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Urinary Tract Tumors Medications


Drugs associated with Urinary Tract Tumors

The following drugs and medications are in some way related to, or used in the treatment of Urinary Tract Tumors. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Urinary Tract Tumors

Micromedex Care Notes:

Bladder Cancer

Medical Encyclopedia:

Bladder cancer Cancer Cancer - renal pelvis or ureter Tumor
Drug List: Theracys Tice-Bcg Tice-Bcg-Vaccine Valstar
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Miscellaneous antineoplastics


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antineoplastics or anticancer drugs affect growth and cell division i.e. are antiproliferative. They work by different mechanisms to prevent the development and spread of neoplastic cells.

They also affect rapidly dividing normal cells, therefore are likely to suppress the bone marrow, suppress growth, impair healing, cause sterility and cause hair loss.

See also

Medical conditions associated with miscellaneous antineoplastics:

Acne Acute Lymphoblastic Leukemia Acute Lymphocytic Leukemia Acute Nonlymphocytic Leukemia Acute Promyelocytic Leukemia Adrenal Cortical Carcinoma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anemia Cancer Cervical Cancer Colorectal Cancer Cutaneous T-cell Lymphoma Esophageal Carcinoma Glioblastoma Multiforme Granuloma Annulare Hodgkin's Lymphoma Leprosy, Erythema Nodosum Leprosum Lymphoma Macular Degeneration Melanoma Melanoma, Metastatic Multiple Myeloma Myelodysplastic Syndrome Non-Small Cell Lung Cancer Ovarian Cancer Pityriasis rubra pilaris Prostate Cancer Renal Cell Carcinoma Rheumatoid Arthritis Rosacea Small Cell Lung Cancer Tuberculosis, Prophylaxis Urinary Tract Tumors Drug List: Hexalen Proleukin Revlimid Sotret Zytiga Accutane Amnesteem Claravis Vesanoid Velcade Vidaza Camptosar Elspar Ergamisol Erwinaze Hycamtin Lysodren Matulane Oncaspar Ontak Photofrin Targretin Thalomid Theracys Tice-Bcg Tice-Bcg-Vaccine Trisenox Visudyne
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OncoTICE


OncoTICE powder for suspension

2-8 X 108 CFU Tice BCG

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Oncotice is and what it is used for 2. Before you are given Oncotice 3. How Oncotice is given 4. Possible side effects 5. How to store Oncotice 6. Further information What Oncotice is and what it is used for

Oncotice contains something called ‘BCG’ (‘Bacillus Calmette-Gu?rin’). This is a bacteria which has been specially altered, so that it can be used as a medicine.

Oncotice is used to: treat bladder cancer prevent bladder cancer from coming back after bladder surgery.

It comes as a powder which is mixed with saline (salt water). It is then run into your bladder through a tube.

BCG is also used as a vaccine for TB (tuberculosis). Oncotice is a much stronger sort of BCG that can’t be used as a vaccine.

Before you are given Oncotice Oncotice should not be given if: You have a urinary tract infection (UTI). This must be treated first. You have blood in your urine. You have or think you have TB (tuberculosis). Before you have Oncotice, your doctor may do a skin reaction test, to see if you have TB. This is called a Tuberculin Test. If you have had Oncotice before, this may give you a positive result in this test. You are HIV-positive. You may need to have a blood test for HIV. Tell your doctor if any of the following apply to you: you have been a drug user and have shared a needle you have had unsafe sex you have had a blood transfusion. You have problems with your immune system. This could be something which runs in the family, or is caused by an illness or other medicines you are taking.

Do not have Oncotice if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before being given Oncotice.

Take special care with Oncotice

Check with your doctor or pharmacist before being given the medicine if:

Your bladder wall or the tube coming into your bladder from your kidneys (called the ‘ureter’) have been damaged during previous treatment.

Treatment with Oncotice will not be given until this has healed.

If you are not sure if any of the above apply to you talk to your doctor or pharmacist before being given Oncotice.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicine. This includes medicines obtained without a prescription, including herbal medicines.

Do not have Oncotice and talk to your doctor straight away if:

You are taking medicines for TB.

The following can lower the effect of Oncotice:

antibiotics medicines which affect the immune system (immuno-suppressants) medicines which affect the production of bone marrow cells (bone marrow suppressants) radiation treatment.

If you are having any of these medicines or are having radiation treatment, your doctor will probably delay giving you Oncotice.

Using Oncotice with food and drink Do not drink any liquid for 4 hours before you are given Oncotice. Do not drink any liquid for 2 hours after you have been given Oncotice. Pregnancy and breast-feeding

Do not have Oncotice if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Oncotice will not affect your being able to drive or use any tools or machines.

Important information about some of the ingredients of Oncotice Oncotice contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before being given this medicine. This medicine contains a very small amount of potassium (less than 1mmol or 39mg per dose). This means it is essentially ‘potassium-free’. How Oncotice is given

You will always be given Oncotice by a doctor or nurse.

Before it is given Do not drink any liquid the 4 hours before Oncotice is given to you. You will be asked to pass water immediately before Oncotice is given to you. Being given your medicine First your genital area will be cleaned with a sterile solution. A nurse will then pass a small flexible tube into your bladder. This will remove any urine that is still in your bladder. Oncotice is then run into your bladder through this tube. This will only take a few minutes. The tube will then be removed. After it has been given Oncotice will be left in your bladder for 2 hours. During this time you should move around a little. This makes sure that the Oncotice is spread around all of your bladder. Do not drink any liquid for 2 hours after you have been given Oncotice. After 2 hours you will be asked to pass water, to empty your bladder. You should do this while sitting down to avoid splashing your urine around the toilet. During the next 6 hours If you need to pass water again, also do this while sitting down. Every time you pass water, add two cups of household bleach to the toilet. Leave the bleach and urine to stand in the toilet for 15 minutes before flushing. How often Oncotice is given

Oncotice is usually given once a week for 6 weeks. After this some people have ‘maintenance therapy’, where you may be given more doses. Your doctor will talk to you about this.

Having sex in the week after having Oncotice

If you have sexual intercourse during the week after being given the medicine, you must use a condom. This will lower the chance of the BCG bacteria being passed to your partner.

If you have more Oncotice than you should

Oncotice is made up from a standard bottle by your doctor, pharmacist or nurse. It is unlikely that you will receive too much Oncotice. If you do have too much, your doctor will check carefully to see whether you have BCG infection.

If necessary you will need to have treatment for TB.

OncoTICE Side Effects

Like all medicines, Oncotice can cause side effects, although not everybody gets them.

If you notice the following side effects, see your doctor straight away: a high temperature (fever) above 39 °C that lasts for more than 12 hours, even after taking medicines like paracetamol to lower your temperature. signs of a BCG or TB infection: cough or bronchitis chest pain or tightness sweating sore throat cold in the nose swelling of your lymph glands.

See your doctor straight away if you notice any of these side effects.

Other side effects include:

Very common

(affects more than 1 in 10 people)

bladder infection, pain when passing water, having to pass water often, feeling the need to pass water and bloody urine. Usually this goes away within two days. flu-like symptoms such as fever and feeling off-colour and tired (malaise). This usually happens about 4 hours after treatment and last for 24 to 48 hours.

Common

(affects less than 1 in 10 people)

painful joints or arthritis muscle pain or stiffness feeling sick (nausea) and being sick (vomiting) abdominal pain or diarrhoea chest infection anaemia problems with passing water or having a large amount of blood in your urine shivering with a high temperature (fever).

Uncommon

(affects less than 1 in 100 people)

skin rash jaundice (yellow colour of your skin or eyes) pus in your urine difficulty passing water low blood count (shown in blood tests)

Rare

(affects less than 1 in every 1,000 people)

inflammation of the genitals or prostate.

Very Rare

(affects less than 1 in every 10,000 people)

headache back pain increased muscle tension swollen legs or arms low blood pressure blood problems (shown in blood tests) flatulence or discomfort following meals loss of appetite or weight loss hair loss prickling or itching skin open sores on your skin eye infection feeling confused, sleepy or dizzy kidney problems

Tell your doctor if any side effect is severe or lasts longer than 48 hours.

If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How to store Oncotice

Keep Oncotice out of the reach and sight of children.

Oncotice will be stored in the hospital according to the instructions given by the manufacturer on the packaging.

Store at 2 °C to 8 °C (in a refrigerator).

Do not use Oncotice after the expiry date which is stated on the carton and label.

Further information What Oncotice contains The active substance is Bacillus Calmette-Gu?rin (BCG). It is a specially treated bacteria to be used as a medicine. The other ingredients are: lactose, asparagine, citric acid (E330), potassium phosphate, magnesium sulfate, iron ammonium citrate, glycerol (E422), ammonium hydroxide (E527), zinc formate. What Oncotice looks like and contents of the pack

Oncotice is a freeze-dried powder, packed in 2 ml glass vials (available in packs of 1), each containing 1 dose of 12.5 mg (equivalent to 2 to 8 x 108 CFU) of BCG.

The Marketing authorisation holder is: N.V. Organon PO Box 20 5340 BH Oss The Netherlands The Manufacturer is: Organon Teknika Corporation 100 Rodolphe Street Building 1300 Durham NC27712 USA

This leaflet was last updated in December 2007.

To listen to or request a copy of this leaflet in braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name: Oncotice

Reference Number: PL 05003/0046

This is a service provided by the Royal National Institute for Blind People

OncoTICE (Tice BCG)

June 2004

REF: USoncviV5.2


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Theracys


Generic Name: bacillus of calmette and guerin vaccine, live (Intravesical route)

ba-SILL-us of KAL-met and GARE-in VAX-een, lyve

Intravesical route(Powder for Suspension)

Bacillus of calmette and guerin infections have been reported in health care workers and patients due to exposure to the vaccine during preparation and administration. Bacillus of calmette and guerin is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical bacillus of calmette and guerin. THERACYS(R) and TICE(R) BCG contains live, attenuated mycobacteria and because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material .

Commonly used brand name(s)

In the U.S.

Theracys Tice BCG

Available Dosage Forms:

Powder for Solution Powder for Suspension

Therapeutic Class: Vaccine

Uses For Theracys

Bacillus Calmette-Gu?rin (BCG) is used as a solution that is run through a tube (instilled through a catheter) into the bladder to treat bladder cancer. The exact way it works against cancer is not known, but it may work by stimulating the body's immune system.

BCG is to be administered only by or under the immediate supervision of your doctor.

Before Using Theracys

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of BCG for treatment of cancer in children with use in other age groups.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aclarubicin Adalimumab Aldesleukin Altretamine Amonafide Amsacrine Asparaginase Azacitidine Azathioprine Bleomycin Broxuridine Busulfan Capecitabine Carboplatin Carmustine Certolizumab Pegol Chlorambucil Cisplatin Cladribine Cyclophosphamide Cytarabine Cytarabine Liposome Dacarbazine Dactinomycin Daunorubicin Daunorubicin Citrate Liposome Decitabine Docetaxel Doxifluridine Doxorubicin Hydrochloride Doxorubicin Hydrochloride Liposome Edatrexate Eflornithine Epirubicin Estramustine Etanercept Etoposide Everolimus Fingolimod Floxuridine Fludarabine Fluorouracil Fotemustine Gallium Nitrate Gemcitabine Golimumab Hydroxyurea Idarubicin Ifosfamide Irinotecan Lomustine Mechlorethamine Melphalan Mercaptopurine Methotrexate Mitolactol Mitomycin Mitotane Mitoxantrone Mycophenolic Acid Oxaliplatin Paclitaxel Pegaspargase Pentostatin Pipobroman Pirarubicin Plicamycin Procarbazine Raltitrexed Rilonacept Rituximab Sirolimus Streptozocin Tacrolimus Teceleukin Tegafur Temsirolimus Teniposide Thioguanine Thiotepa Topotecan Treosulfan Trimetrexate Trofosfamide Uracil Mustard Ustekinumab Vinblastine Vincristine Vincristine Liposome Vindesine Vinorelbine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abatacept Leflunomide Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Fever—Infection may be present and could cause problems Immunity problems—BCG treatment is less effective and there is a risk of infection Urinary tract infection—Infection and irritation of the bladder may occur Proper Use of bacillus of calmette and guerin vaccine, live

This section provides information on the proper use of a number of products that contain bacillus of calmette and guerin vaccine, live. It may not be specific to Theracys. Please read with care.

Your doctor will ask you to empty your bladder completely before the solution is instilled into it.

Follow your doctor's instructions carefully about how long to hold the solution in your bladder:

The solution should be held in your bladder for 2 hours. If you think you cannot hold it, tell your health care professional. During the first hour, your doctor may have you lie for 15 minutes each on your stomach, back, and each side. When you do empty your bladder, you should be sitting down.

It is important that you drink extra fluids for several hours after each treatment with BCG so that you will pass more urine. Also, empty your bladder frequently. This will help prevent bladder problems.

BCG is a live product. In other words, it contains active bacteria that can cause infection. Some bacteria will be present for several hours in urine that you pass after each treatment with BCG. Any urine that you pass during the first 6 hours after each treatment should be disinfected with an equal amount (usually about 1 cup) of undiluted household bleach. After the bleach is added to the urine, it should be allowed to sit for 15 minutes before it is flushed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using Theracys

While you are being treated with BCG, and for 6 to 12 weeks after you stop treatment with it, avoid contact with people who have tuberculosis. If you think you have been exposed to someone with tuberculosis, tell your doctor.

While you are being treated with BCG and for a few weeks after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval.

Theracys Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common Blood in urine fever and chills frequent urge to urinate increased frequency of urination joint pain nausea and vomiting painful urination (severe or continuing) Rare Cough skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Burning during first urination after treatment

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Cough fever

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Theracys side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Theracys resources Theracys Side Effects (in more detail) Theracys Use in Pregnancy & Breastfeeding Theracys Drug Interactions Theracys Support Group 0 Reviews for Theracys - Add your own review/rating BCG Vaccine Prescribing Information (FDA) TheraCys Concise Consumer Information (Cerner Multum) TheraCys MedFacts Consumer Leaflet (Wolters Kluwer) Compare Theracys with other medications Tuberculosis, Prophylaxis Urinary Tract Tumors
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Carbon Dioxide Oxygen Mixture


Dosage Form: gas
Carbon Dioxide Oxygen Mixture

COMPRESSED GAS, OXIDIZING, N.O.S.
(  % CARBON DIOXIDE USP,    %OXYGEN USP) UN 3156 NON-FLAMMABLE 2    OXIDIZER 5.1   30460D (06/02)
OXYGEN CONTENT OVER 23.5% Rx only. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. WARNING: Administration of this gas may be hazardous or contraindicated. For use only by under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindication and side effects, and the precautions to be taken. CAUTION: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. MIXTURES CONTAINING CARBON DIOXIDE CAN INCREASE RESPIRATION AND HEART RATE. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Cylinder temperature should not exceed 52C (125F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.  CARBON DIOXIDE CAS: 124-38-9 OXYGEN CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
FILLED and INSPECTED BY GENERAL AIR SERVICE and SUPPLY DENVER, CO 80204

COMPRESSED GAS, OXIDIZING, N.O.S.
(  % CARBON DIOXIDE USP,    %OXYGEN USP) UN 3156 NON-FLAMMABLE 2    OXIDIZER 5.1   30460D (06/02)
OXYGEN CONTENT OVER 23.5% Rx only. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. WARNING: Administration of this gas may be hazardous or contraindicated. For use only by under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindication and side effects, and the precautions to be taken. CAUTION: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. MIXTURES CONTAINING CARBON DIOXIDE CAN INCREASE RESPIRATION AND HEART RATE. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Cylinder temperature should not exceed 52C (125F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.  CARBON DIOXIDE CAS: 124-38-9 OXYGEN CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
FILLED and INSPECTED BY GENERAL AIR SERVICE and SUPPLY DENVER, CO 80204


Carbon Dioxide Oxygen Mixture 
Carbon Dioxide Oxygen Mixture  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 21220-129 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbon Dioxide (Carbon Dioxide) Carbon Dioxide 200 mL  in 1 L Oxygen (Oxygen) Oxygen 800 mL  in 1 L Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 21220-129-01 7101 L In 1 CYLINDER None 2 21220-129-02 707 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1975
Labeler - General Air Service & Supply Co (151227338) Establishment Name Address ID/FEI Operations General Air Service & Supply Co 006686091 manufacture Revised: 10/2010General Air Service & Supply Co

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Cytarabine Injection Solution


1. Name Of The Medicinal Product

Cytarabine Injection Solution 20 mg/ml and 100 mg/ml

2. Qualitative And Quantitative Composition

For Cytarabine Injection Solution 100 mg/ml: Cytarabine BP 100 mg/ml

For Cytarabine Injection Solution 20 mg/ml: Cytarabine BP 20 mg/ml

There is no overage for these formulations.

3. Pharmaceutical Form

Cytarabine Injection Solution 100 mg/ml: Aqueous, sterile solution for injection.

Cytarabine Injection Solution 20 mg/ml: Aqueous, sterile, isotonic solution for injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Cytarabine may be used alone or in combination with other antineoplastic agents. It is indicated alone or in combination for induction of remission and/or maintenance in patients with acute myeloid leukaemia, acute non-lymphoblastic leukaemias, acute lymphoblastic leukaemias, acute lymphocytic leukaemia, erythroleukaemia, blast crises of chronic myeloid leukaemia, diffuse histiocytic lymphomas (non-Hodgkin's lymphomas of high malignancy), meningeal leukaemia and meningeal neoplasms. Clinicians should refer to the current literature on combination therapy before initiating treatment.

Cytarabine Injection Solution is a ready to use solution with a concentration of 20 mg/ml and 100 mg/ml. The 20 mg/ml presentation is suitable for intravenous, subcutaneous and intrathecal use.

Cytarabine Injection Solution 100 mg/ml can be administered by the intravenous and subcutaneous routes. Cytarabine Injection Solution 100 mg/ml should not be administered by the intrathecal route due to the slight hypertonicity of this formulation. (See side effects section).

Cytarabine Injection Solution can be diluted with Sterile Water for Injection BP, Glucose Injection BP or Sodium Chloride 0.9% Injection BP. Prepared infusions, in the recommended diluents should be used immediately. Alternatively, the diluted infusion fluids may be stored at 2-8°C, protected from light, but portions remaining unused after 24 hours must be discarded.

4.2 Posology And Method Of Administration

Remission Induction: Adults.

Continuous Dosing: The usual dose in leukaemia, is 2 mg/kg by rapid intravenous injection daily for ten days. If after ten days neither therapeutic response nor toxicity has been observed, the dose may be increased to 4 mg per kg until a therapeutic response or toxicity is evident. Daily blood counts should be taken. Almost all patients can be carried to toxicity with these doses.

Alternatively, 0.5 to 1 mg/kg may be infused daily in 1-24 hours for ten days, and then at a rate of 2 mg/kg/day until toxicity is observed. Continue to toxicity or until remission occurs. Results from one hour infusions have been satisfactory in the majority of patients.

Intermittent dosing: Cytarabine may be given as intermittent IV doses of 3-5 mg/kg daily, for Five consecutive days This course of treatment can be repeated after an interval of 2 to 9 days, and repeated until the therapeutic response or toxicity is exhibited.

Evidence of bone marrow improvement has been reported to occur 7-64 days after the beginning of therapy.

In general, if a patient shows neither remission nor toxicity after a trial period, then cautiously administered higher doses can be administered. Generally patients tolerate higher doses given by rapid intravenous injection rather than slow infusion.

As a single agent for induction of remissions in patients with acute leukaemia, Cytarabine has been given in doses of 200 mg/m2 by continuous IV Infusion for five days at approximately 2 week intervals.

Maintenance therapy: To maintain remission, doses of 1-1.5 mg/kg may be given intravenously or subcutaneously, once or twice weekly.

Leukaemic Meningitis: Therapy for established meningitis employs a wide variety of dose regimens but a recommended total daily dose not exceeding 100 mg, alternating with Methotrexate (given either systemically or intrathecally) is recommended. Cytarabine Injection has been given intrathecally at doses of 10-30 mg per m2 three times a week until CSF findings return to normal. Cytarabine Injection Solution 100mg/mL should not be administered by the intrathecal route due to the slight hypertonicity of this formulation. (See side effects section).

Myelosuppression, anaemia and thrombocytopenia occur almost to all patients given daily infusions or injections. Myelosuppression is biphasic and nadirs at 7-9 and 15-24 days. Evidence of bone marrow improvement may be expected 7-64 (mean 28) days after the beginning of treatment.

Children: Children appear to tolerate higher doses of Cytarabine than adults, and where the range of doses is given, children should receive the higher dose.

Elderly: No data is available to suggest that a change in dose is necessary in the elderly. However, the elderly patient is more susceptible to toxic reactions and therefore particular attention should be paid to drug induced leucopenia, thrombocytopenia and anaemia.

4.3 Contraindications

Cytarabine is contraindicated in patients with known hypersensitivity to the drug. Therapy with Cytarabine should not be considered in patients with pre-existing drug-induced bone marrow suppression, unless in the opinion of the physician the potential benefits outweigh the hazards. Cytarabine should not be used in the management of non-malignant disease, except for immunosuppression.

4.4 Special Warnings And Precautions For Use

Special Warnings and Precautions:

Cytarabine is a potent bone marrow suppressant. Patients receiving the drug should be kept under close medical supervision. Leucocyte and platelet counts should be performed frequently and daily during induction. One case of anaphylaxis that resulted in cardiopulmonary arrest and necessitated resuscitation has been reported. This occurred immediately after intravenous Cytarabine was administered.

Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of dosage schedules). These reactions include reversible corneal toxicity; cerebral and cerebellar dysfunction, usually reversible; severe gastrointestinal ulceration including pneumatosis cysteroides intestinalis, leading to peritonitis; sepsis and liver abscess; and pulmonary oedema.

Cytarabine has been shown to be mutagenic and carcinogenic in animals.

Cytarabine should only be used under the constant supervision by physicians experienced in therapy with cytotoxic agents. Hyperuricaemia secondary to lysis of neoplastic cells may occur in patients receiving Cytarabine; serum uric acid concentrations should be monitored.

Periodic determinations of renal and hepatic functions and bone marrow should also be performed and the drug should be used with caution in patients with impaired hepatic function.

However, dosage reduction does not appear to be necessary in patients with impaired renal function. The human liver apparently detoxifies a substantial fraction of the administered dose. The drug should be used with caution and at a reduced dose when liver function is poor. Frequent platelet and leucocyte counts are mandatory. Therapy should be suspended or modified when drug-induced bone marrow depression results in a platelet count of less than 50,000 or a polymorphonuclear count of under 1000 per cubic mm. Counts may continue to fall after the therapy has been discontinued and may reach lowest values after five to seven days. Therapy may be restarted when the bone marrow appears to be recovering on successive bone marrow studies. Therapy should not wait until the normal blood values are obtained to be re-initiated.

When intravenous doses are given quickly, patients may become nauseated and may vomit for several hours afterwards. The problem tends to be less severe when infused.

The safety of the drug has not been established in infants.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

i) Cardiac Glycosides

G.I. absorption of oral digoxin tablets may be substantially reduced in patients receiving combination chemotherapy regimens (including regimens containing cytarabine), possibly as a result of temporary damage to intestinal mucosa caused by the cytotoxic agents. Limited data suggest that the extent of G.I. absorption of digitoxin is not substantially affected by concomitant administration of combination chemotherapy regimens known to decrease absorption of digoxin.

ii) Anti-Infective Agents

One in vitro study indicates that cytarabine may antagonise the activity of gentamicin against Klebsiella pneumoniae. Limited data may suggest that cytarabine may antagonise the anti-infective activity of flucytosine, possibly by competitive inhibition of the anti-infective uptake by fungi.

4.6 Pregnancy And Lactation

Use in Pregnancy:

Cytarabine is teratogenic in some animal species. It should not be used in pregnant women (especially during the first trimester), or in those who may become pregnant, unless the possible benefits outweigh the potential risks. Women who are, or become, pregnant during treatment with Cytarabine should be informed of the risks.

Use in Lactation:

It is not known if Cytarabine or its metabolite is distributed into breast milk, and it should not be used.

4.7 Effects On Ability To Drive And Use Machines

No documented effect on ability to drive or operate machinery.

4.8 Undesirable Effects

Haematological Effects:

The major adverse effect of Cytarabine is the haematological toxicity. Myelosuppression is manifested by megaloblastosis, reticulocytopenia, thrombocytopenia and anaemia.

These appear to be more evident after high doses and continuous infusions; the severity depends on the dose of the drug and schedule of administration.

GI Effects:

Nausea and vomiting occur and are generally more frequent following rapid IV administration than with continuous IV infusion of the drug.

Diarrhoea, anorexia, oral and anal inflammation or ulceration and less frequently abdominal pain, sore throat, oesophagitis, oesophageal ulceration and gastrointestinal haemorrhage may also occur.

Other reported adverse effects of Cytarabine include fever, rash, alopecia, skin ulceration, conjunctivitis, chest pain, urinary retention, dizziness, neuritis or neural toxicity and pain, cellulitis or thrombophlebitis at the site of injection. Cytarabine has also been associated with renal dysfunction, hepatic dysfunction and jaundice in some patients. It has also been associated with sepsis, irritation or sepsis at the injection site, neuritis or neurotoxicity rash, freckling, skin and mucosal bleeding, chest pain, joint pain and reduction in reticulocytes.

A Cytarabine reaction is characterised by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis and malaise. It usually occurs 6-12 hours after administration. Corticosteroids have been shown to be beneficial in treating or preventing this syndrome. If the symptoms of the syndrome are serious enough to warrant treatment, corticosteroids should be contemplated as well as continuation of Cytarabine therapy.

4.9 Overdose

Cessation of therapy followed by management of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics as required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits DNA polymerase and may also inhibit certain acid kinase enzymes. Primarily the drug acts as a false nucleoside and competes for enzymes involved in the conversion of Cytidine nucleotide to deoxycytidine nucleotide and also incorporation into the DNA.

Cytarabine has no effect on non proliferating cells nor on proliferating cells unless in the S phase. It is a cell cycle specific antineoplastic drug.

5.2 Pharmacokinetic Properties

Oral administration is ineffective due to rapid deamination in the gut. Cytidine deaminase is concentrated in the liver and intravenous doses show biphasic elimination with half lives of approximately 10 minutes and 1-3 hours.

After 24 hours 80% of a dose has been eliminated either as the inactive metabolite or as the unchanged Cytarabine, mostly in urine but some in bile.

CSF levels of 50% of plasma levels are achieved with IV infusion. Intrathecal dosing results in slower elimination (T1/2 2-11 hours).

Cytarabine is rapidly and widely distributed into tissues, crosses the blood brain barrier and also the placenta.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Cytarabine Injection Solution 100 mg/ml: Water for Injections BP

Cytarabine Injection Solution 20 mg/ml: Sodium Chloride BP

Water for Injections BP

6.2 Incompatibilities

Solutions of Cytarabine have been reported to be incompatible with various drugs, i.e. Carbenicillin Sodium, Cephalothin Sodium, Fluorouracil, Gentamicin Sulphate, Heparin Sodium, Hydrocortisone Sodium Succinate, Insulin-regular, Methylprednisolone Sodium Succinate, Nafacillin Sodium, Oxacillin Sodium, Penicillin G Sodium. However, the incompatibility depends on several factors (e.g. concentrations of the drug, specific diluents used, resulting pH, temperature). Specialised references should be consulted for specific compatibility information.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C. Protect from Light.

In diluted infusion fluids store at 2-8°C and protect from light for a maximum of 24 hours.

6.5 Nature And Contents Of Container

Cytarabine Injection Solution 20mg/ml is supplied in the following packs in both conventional glass vials and ONCO-TAIN® vials:

100 mg in 5 ml vial: Pack of 5

500 mg in 25 ml vial: Singles

1 gram in 50 ml vial: Singles

Cytarabine Injection Solution 100mg/ml is supplied in the following packs in conventional glass vials and ONCO-TAIN® vials:

100 mg in 1ml vial: Pack of 5

500 mg in 5 ml vial: Pack of 5 and Singles

1 g in 10 ml vial: Singles

2 g in 20 ml vial: Singles

Cytarabine Injection Solution 100mg/ml is also supplied in the following packs in ONCO•VIALS®:

100mg in 1ml vial: Pack of 5 and Singles

500mg in 5ml vial: Pack of 5 and Singles

1g in 10ml vial: Pack of 5 and Singles

2g in 20ml vial: Pack of 5 and Singles

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Faulding Pharmaceuticals Plc

Queensway

Royal Leamington Spa

Warwickshire, CV31 3RW

United Kingdom

8. Marketing Authorisation Number(S)

Cytarabine Injection Solution 100 mg/ml: PL 04515/0057

Cytarabine Injection Solution 20 mg/ml: PL 04515/0040

9. Date Of First Authorisation/Renewal Of The Authorisation

Cytarabine Injection Solution 100 mg/ml: 7th July 1992/ 9th September 1997

Cytarabine Injection Solution 20 mg/ml: 7th July 1992/ 10 September 1997

10. Date Of Revision Of The Text

14 August 2001

11 Legal Category

POM


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Robinul Powder


1. Name Of The Medicinal Product

Robinul Powder

2. Qualitative And Quantitative Composition

Robinul Powder consists of Glycopyrrolate (glycopyrronium bromide) 100% w/w.

3. Pharmaceutical Form

White, crystalline powder.

4. Clinical Particulars 4.1 Therapeutic Indications

Iontophoretic treatment of the plantar and palmar skin for idiopathic hyperhidrosis.

4.2 Posology And Method Of Administration

Route of Administration: Iontophoresis

Dosage and Administration:

A 0.05% solution in distilled water of Glycopyrrolate USP is applied to palmar or plantar skin. When treating the foot or hand, sufficient solution to cover the palm or sole is placed in a non-metallic container and the anode, of sheet metal larger in area than the part being treated, is placed in the solution. The sole or palm is separated from the anode by 5mm of plastic foam or a layer of lint or sponge sheet.

In all cases an electrical circuit is completed by placing another limb in lukewarm tap water containing the cathode, similarly shielded from direct contact with the skin.

Recommended average conditions are 90 volts DC at 10-20 mA for adults (including older patients) and 2-10 mA for children, for 12 minutes at each site, depending on the patient's skin tolerance, body weight and size. Only one site should be treated at a time and only two sites in any one day. Treatments should not be repeated within seven days, but may be repeated later varying the precise conditions according to the recurrence and severity of hyperhidrosis. See also 'Special warnings and special precautions for use' below.

4.3 Contraindications

Glaucoma. Do not use during pregnancy.

4.4 Special Warnings And Precautions For Use

Glycopyrrolate may cause tachycardia.

This product should be used with great caution in patients with cardiovascular disease, thyrotoxicosis and obstructive disorders of the lower urinary tract. Patients with mycotic or other skin infections should not be treated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not applicable.

4.6 Pregnancy And Lactation

Do not use during pregnancy, as safety in this condition has not been established. Reproduction studies in rats and rabbits revealed no teratogenic effects from glycopyrrolate. However, diminished rates of conception and of survival at weaning were observed in rats, in a dose related manner. Studies in dogs suggest that this may be due to diminished seminal secretion, which is evident at high doses of glycopyrrolate. The significance of this for man is not clear.

4.7 Effects On Ability To Drive And Use Machines

Since this drug may cause drowsiness, patients receiving glycopyrrolate should not drive or operate machinery immediately after treatment unless it has been shown not to affect their physical or mental ability.

4.8 Undesirable Effects

Dryness of the mouth, blurred vision and mild abdominal discomfort may occur. Exercise care in patients with prostatic hypertrophy. Due to the effect of anticholinergics on mucous secretions, it is advisable not to treat people with chronic bronchitis. Occasionally difficulty in eating may occur and micturition may be temporarily affected for some hours after treatment. A mild tingling feeling may occur in the immersed areas during treatment and any recent cuts or cracks in the skin may smart when the current is increased at the start of iontophoresis. The latter can be avoided by covering the lesion with a thin smear of petroleum jelly. Avoid over-exertion especially in hot weather, until any side effects have disappeared.

4.9 Overdose

Not appropriate for the product.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Glycopyrrolate is an anticholinergic agent. The pharmacological particulars of anticholinergic drugs are well documented in the scientific literature.

5.2 Pharmacokinetic Properties

This product is indicated for use by Topical Iontophoresis for hyperhidrosis. Glycopyrrolate is a Quaternary Ammonium Compound and as such is absorbed through the skin in negligible amounts only.

5.3 Preclinical Safety Data

Nothing of relevance to the prescriber.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Not applicable - no other constituents present.

6.2 Incompatibilities

None.

6.3 Shelf Life

48 months unopened. 14 days after reconstitution.

6.4 Special Precautions For Storage

There are no special storage precautions for this product.

6.5 Nature And Contents Of Container

The product is presented in a screw cap amber bottle containing 3, 5 or 10g of glycopyrrolate USP.

6.6 Special Precautions For Disposal And Other Handling

The product should only be used by specialist units experienced in IONTOPHORETIC technique. The electrodes and treated skin areas must be placed in non-metallic containers and separated carefully by layers of, for example, sponge or lint. Direct contact between electrodes and skin must be avoided otherwise burns may result. The current must be very slowly increased from zero mA and decreased to zero mA at the beginning and end of the treatment period respectively to avoid any Faradic discharge between the electrode and skin on removal of the patient's limb from the container of solution. Instruct patient that contact must not be broken during treatment. Prior to use in iontophoresis a stock solution of Robinul powder (glycopyrrolate) may be made up with freshly boiled and cooled distilled or deionised water. Glycopyrrolate does hydrolyse slowly at pH 7 and it is recommended that stock solutions be discarded after not more than 14 days.

The solution must not be alkaline otherwise glycopyrrolate will hydrolyse more rapidly.

ADMINISTRATION DETAILS

7. Marketing Authorisation Holder

Anpharm Limited

Roscrea

Co. Tipperary

Ireland

8. Marketing Authorisation Number(S)

PL 15372/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

1st July, 1997.

10. Date Of Revision Of The Text

May, 2003.


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Vaniqa Topical


Generic Name: eflornithine (Topical route)

ef-LOR-ni-theen

Commonly used brand name(s)

In the U.S.

Vaniqa

Available Dosage Forms:

Cream

Therapeutic Class: Hair Growth Retardant

Pharmacologic Class: Ornithine Decarboxylase Inhibitor

Uses For Vaniqa

Eflornithine is used to slow down bodily substances called enzymes that help hair grow. The effect is slower facial hair growth.

This medicine is available only with your doctor's prescription.

Before Using Vaniqa

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of eflornithine in children under the age of 12 years with use in other age groups. However, this medicine is not expected to cause different side effects or problems in older children than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Vaniqa

This medicine comes with a patient instruction sheet. Read this sheet carefully and follow the directions. If you have any questions on how to use this medicine, be sure to ask your health care professional.

This medicine is usually used on the face and nearby involved areas under the chin only. Do not get the medicine in your eyes, nose, or mouth. Rinse thoroughly with water and contact your doctor if the medicine gets in the eyes

You need to continue your normal hair removal procedures while using this medicine, and the medicine should be applied at least five minutes after the unwanted hair has been removed. You should wait until the medicine dries before applying cosmetics or sunscreen.

Do not wash the treated areas for at least 4 hours after applying the medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage form (cream): For reduced rate of facial hair growth in women. Adults and children 12 years of age or older—Coat the problem areas on the face and nearby areas under the chin with the medicine two times a day with the second treatment coming at least eight hours after the first. Children under 12 years of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Vaniqa

If skin irritation occurs, reduce the frequency of treatments. If irritation continues, stop using the medicine and contact your doctor.

If no improvement is seen after six months of treatment, stop using the medicine and contact your doctor.

If condition gets worse while you use the medicine, stop the medicine and contact your doctor.

Vaniqa Side Effects

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Acne stinging skin Less common Burning or bleeding skin chapped, red lips chronic acne hair bumps numbness rash reddening of skin swelling of lips tingling skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Vaniqa Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Vaniqa Topical resources Vaniqa Topical Side Effects (in more detail) Vaniqa Topical Use in Pregnancy & Breastfeeding Vaniqa Topical Support Group 8 Reviews for Vaniqa Topical - Add your own review/rating Compare Vaniqa Topical with other medications Hirsutism
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Geref Diagnostic


Generic Name: sermorelin (Injection route)

ser-moe-REL-in

Commonly used brand name(s)

In the U.S.

Geref Geref Diagnostic

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Growth Hormone Releasing Hormone Analog

Uses For Geref Diagnostic

Sermorelin is a synthetic (man-made) version of a naturally occurring substance that causes release of growth hormone from the pituitary gland. Growth hormone is naturally produced by the pituitary gland and is necessary for growth in children. In children who fail to grow normally because their bodies are not producing enough growth hormone, this medicine may be used to increase the amount of growth hormone produced by the pituitary gland.

This medicine is available only with your doctor's prescription.

Before Using Geref Diagnostic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Underactive thyroid—This condition can interfere with the effects of sermorelin Proper Use of sermorelin

This section provides information on the proper use of a number of products that contain sermorelin. It may not be specific to Geref Diagnostic. Please read with care.

If you are injecting this medicine yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine needed has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve the condition.

Each package of sermorelin contains a patient instruction sheet. Read this sheet carefully and make sure you understand:

How to prepare the injection. Proper use of disposable syringes and needles, including safe handling and disposal. How to give the injection. How long the injection is safe to use.

It is best to use a different place on the body for each injection (for example, abdomen, hip, thigh, or upper arm). To help you remember to do this, you may want to keep a record of the date and location for each injection.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Geref Diagnostic

It is very important that your doctor check your progress at regular visits.

Geref Diagnostic Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common Pain, redness, or swelling at the place of injection Rare Itching trouble in swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare Dizziness flushing headache sleepiness trouble sitting still

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Geref Diagnostic resources Geref Diagnostic Use in Pregnancy & BreastfeedingGeref Diagnostic Support Group0 Reviews · Be the first to review/rate this drug Geref MedFacts Consumer Leaflet (Wolters Kluwer)
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Octreotide Mayne


Octreotide Mayne 50 micrograms/1ml solution for injection

Octreotide Mayne 100 micrograms/1ml solution for injection

Octreotide Mayne 200 micrograms/ml solution for injection

Octreotide Mayne 500 micrograms/1 ml solution for injection

Octreotide acetate

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Octreotide Mayne is and what it is used for 2. Before you use Octreotide Mayne 3. How to use Octreotide Mayne 4. Possible side effects 5. How to store Octreotide Mayne 6. Further information What Octreotide Mayne is and what it is used for

Octreotide Mayne is a synthetic version of a hormone that occurs naturally in the body, called somatostatin. Octreotide inhibits the release of growth hormone and some gut hormones and secretions.

Octreotide Mayne is used:

To treat the symptoms that occurs with hormone producing gastrointestinal tumours. These symptoms are associated with the over-production of some of the body's natural substances which may result in an imbalance of your natural hormone levels. This imbalance may cause a variety of symptoms in the stomach, pancreas or intestines (gut). To reduce the levels of growth hormone and Insulin-like growth factor number 1 (IGF-1) if you have acromegaly and to improve symptoms that you may have due to over-production of these hormones. Prior to having an operation on the pancreas, to prevent further complications. Before you use Octreotide Mayne Octreotide Mayne should not be used if you are: allergic to octreotide or any of the ingredients in Octreotide Mayne (see Section 6). Special care will be taken: as Octreotide may affect your blood sugar levels. You or your doctor should closely monitor your blood sugar levels. if you have a tumour (growth) that produces insulin (insulinoma). You or your doctor should closely monitor your blood sugar levels. if you have any thyroid problems if you have gallstones if you have liver disease if you are pregnant or planning to become pregnant. If you do become pregnant, tell your doctor immediately. if you are breast-feeding Taking other medicines:

Please tell your doctor if you are taking any of the following medicines;

ciclosporin (a drug used after a transplant) cimetidine (a drug used to reduce stomach acid) bromocriptine (a drug used in Parkinson's disease or in acromegaly or to suppress breast milk) terfenadine (to relieve allergic symptoms) carbamazepine (a drug used in psychiatric disorders, epilepsy, trigeminal neuralgia and neuropathy) digoxin (medicine for certain heart problems) warfarin (a drug used to thin the blood)

Other medicines that are metabolised by the liver can also be affected, so tell your doctor or pharmacist about all the medicines you are taking.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use Octreotide if you are pregnant, unless you have been told by your doctor that it is absolutely necessary for you to do so.

You should not breastfeed your infant whilst receiving treatment with Octreotide, unless you have been told to do so.

How to use Octreotide Mayne injection

Always use Octreotide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure of anything.

A doctor or nurse will usually give you this medicine.

The medicine will be given to your either as a subcutaneous injection (underneath the skin) or as a slow intravenous injection (via a drip into the vein).

The usual dosages are given below; however your doctor will decide what dosage to give to you, as this depends on the nature of your treatment, your age and your medical condition:

To treat the symptoms that occur with hormone producing gastrointestinal tumours: 50 micrograms each 24 hours or each 12 hours, depending on your response, the dose may be increased to 100 to 200 micrograms every 8 hours. The usual recommended maximum daily dosage is 600 micrograms. If you have acromegaly: initial doses of 50 to 100 micrograms, every 8 hours. For most patients the dosage is 200 to 300 micrograms per day and the maximum daily dosage is 1500 micrograms. Prior to having an operation on the pancreas: 100 micrograms every 8 hours for 7 days, starting on the day of the operation.

Your injection should be given between meals or at bedtime in order to reduce stomach and intestinal (gut) side effects.

To reduce discomfort, Octreotide Mayne solution for injection should reach room temperature before administration. Multiple subcutaneous injections at short intervals at the same administration site should be avoided.

If you use more Octreotide Mayne than advised: if you think you have had too much Octreotide, tell your doctor or nurse immediately.

Octreotide Mayne Side Effects

As other medicinal products, Octreotide Mayne injection can cause side effects although not everybody gets them.

If any of the following happen, tell your doctor immediately: severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing). pancreatitis - this may give you sudden severe pains in your abdomen. It may occur in the first few hours or days of treatment. intestinal obstruction - you may feel constipation and pains.

These are very serious side effects. You may need urgent medical attention. These side effects are rare (occur in less than 1 in 1000 patients but more than 1 in 10,000).

Tell your doctor as soon as possible if you notice any of the following side effects:

Common (occurs in less than 1 in 10 patients but more than 1 in 100):

changes in blood sugar levels (both high or low levels may occur) diarrhoea vomiting steatorrhea (fatty material in the faeces) flatulence - excessive gas in your stomach or bowels feeling sick stomach pain gallstones that could gives gallbladder pain pain where the injection has been given

Uncommon (occurs in less than 1 in 100 patients but more than 1 in 1000):

severe loss of appetite (anorexia) being sick epigastric pain (pain in upper part of stomach)

Rare (occurs in less than 1 in 1000 patients but more than 1 in 10,000):

ileus-like conditions (your gut may not work properly) loss of hair rashes heart beating slower than normal

Your doctor will take blood tests to check for changes in liver function, which is a side effect of treatment with Octreotide.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Octreotide Mayne

Store in a refrigerator (2°C - 8°C). Do not freeze. Store the vial in the outer carton in order to protect the product from light.

The multidose vials of Octreotide 200 micrograms/ml solution for injection for daily use may be stored for two weeks below 25°C.

Octreotide Mayne, diluted in 0.9% sodium chloride would not normally be stored for longer than 24 hours in a refrigerator.

Keep out of the reach and sight of children.

Do not use Octreotide after the expiry date stated on the carton and label.

The injection should only be used if it is clear and free of particles.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

Other information

Octreotide Mayne is available as vials containing a clear, colourless solution for injection. It contains octreotide as the active ingredient.

The vials also contain Glacial Acetic Acid, Sodium Acetate Trihydrate, Sodium Chloride and Water for Injections. The multi-dose vials additionally contain Phenol (a preservative).

This medicinal product contains less than 1 mmol (23 mg) of sodium (i.e., essentially sodium free) per ml of solution.

Octreotide Mayne is available in the following pack sizes: Octreotida Mayne solution for injection 50 micrograms/1 ml (packs of 5, or 30 vials) Octreotida Mayne solution for injection 100 micrograms/1 ml (packs of 5, or 30 vials) Octreotida Mayne solution for injection 500 micrograms/1 ml (packs of 5, or 30 vials) Octreotida Mayne solution for injection 200 micrograms/ ml (packs of 1 or 10 multidose vials)

The vials may be overwrapped with a protective plastic to minimise the risk of spillage if the vials break; these vials are referred to as ONCO-TAIN.

Marketing authorisation holder and manufacturer: Mayne Pharma Plc Queensway Royal Leamington Spa Warwickshire CV31 3RW United Kingdom

This leaflet was last approved in June 2007


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Fluorouracil 25 mg / ml Injection (Hospira UK Ltd)


1. Name Of The Medicinal Product

Fluorouracil 25mg/ml Injection.

2. Qualitative And Quantitative Composition

Each 1 ml contains 25mg of fluorouracil.

Presentations

250mg / 10ml

500mg / 20ml

2.5g / 100ml

Amount fluorouracil present (as sodium salt) per vial

250mg

500mg

2.5g

For excipients see 6.1

3. Pharmaceutical Form

Solution for injection.

Clear, colourless or slightly yellow solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Fluorouracil may be used alone, or in combination, for the management of common malignancies particularly cancer of the colon and breast.

4.2 Posology And Method Of Administration

Adults:

Selection of an appropriate dose and treatment regime depends upon the condition of the patient, the type of carcinoma being treated and whether fluorouracil is to be administered alone or in combination with other therapy. Initial treatment should be given in hospital and the total daily dose should not exceed 0.8 - 1 gram. It is customary to calculate the dose in accordance with the patient's actual bodyweight unless there is obesity, oedema or some form of abnormal fluid retention such as ascites. Ideal weight is used as the basis for calculation in such cases. The initial dose should be reduced by one-third to one half in patients with any of the following:

1. Cachexia.

2. Major surgery within preceding 30 days.

3. Reduced bone marrow function.

4. Impaired hepatic or renal function.

Initial Treatment:

This may be in the form of an infusion or an injection, the former usually being preferred because of lesser toxicity.

Intravenous infusion:

15mg/kg bodyweight but not more than 1g per infusion, diluted in 300 - 500ml of 5% glucose or 0.9% NaCl injection and given over 4 hours. Alternatively the daily dose may be infused over 30 - 60 minutes or may be given as a continuous infusion over 24 hours. The infusion may be repeated daily until there is evidence of toxicity or a total dose of 12 - 15g has been reached.

Intravenous Injection:

12mg/kg bodyweight may be given daily for 3 days and then, if there is no evidence of toxicity, 6mg/kg on alternate days for 3 further doses.

An alternative regimen is 15mg/kg as a single intravenous injection once a week throughout the course.

Intra-arterial infusion:

5/7.5mg/kg bodyweight daily may be given by 24 hour continuous intra-arterial infusion.

Maintenance therapy:

An initial intensive course may be followed by maintenance therapy providing there are no significant toxic effects.

In all instances, toxic side effects must disappear before maintenance therapy is started.

The initial course of fluorouracil can be repeated after an interval of 4 to 6 weeks from the last dose or, alternatively, treatment can be continued with intravenous injections of 5-15mg/kg bodyweight at weekly intervals.

This sequence constitutes a course of therapy. Some patients have received up to 30g at a maximum rate of 1 g daily.

A more recent alternative method is to give 15mg/kg IV once a week throughout the course of treatment. This obviates the need for an initial period of daily administration.

In combination with irradiation

Irradiation combined with fluorouracil has been found to be useful in the treatment of certain types of metastatic lesions in the lungs and for the relief of pain caused by recurrent, inoperable growth. The standard dose of fluorouracil should be used.

Children:

No recommendations are made regarding the use of fluorouracil in children.

Elderly:

Fluorouracil should be used in the elderly with similar considerations as in younger adults. notwithstanding that incidence of concomitant medical illness is higher in the former group.

4.3 Contraindications

Fluorouracil is contraindicated in seriously debilitated patients or those with bone marrow depression after radiotherapy or treatment with other antineoplastic agents.

Fluorouracil is strictly contraindicated in pregnant or breast feeding women.

Fluorouracil should not be used in the management of non-malignant disease.

4.4 Special Warnings And Precautions For Use

It is recommended that fluorouracil be given only by, or under the strict supervision of , a qualified physician who is conversant with the use of potent antimetabolites.

All patients should be admitted to hospital for initial treatment.

Adequate treatment with fluorouracil is usually followed by leucopenia, the lowest white blood cell (W.B.C.) count commonly being observed between the 7th and 14th day of the first course, but occasionally being delayed for as long as 20 days. The count usually returns to normal by the 30th day. Daily monitoring of platelet and W.B.C. Count is recommended and treatment should be stopped if platelets fall 100,000 per mm3 or the W.B.C. count falls below 3,500 per mm3. If the total count is less than 2000 per mm3, and especially if there is granulocytopenia, it is recommended that the patient be placed in protective isolation in the hospital and treated with appropriate measures to prevent systemic infection.

Treatment should also be stopped at the first sign of oral ulceration or if there is evidence of gastrointestinal side effects such as stomatitis, diarrhoea or bleeding from the gastrointestinal tract or haemorrhage at any site. The ratio between effective and toxic dose is small and therapeutic response is unlikely without some degree of toxicity. Care must be taken therefore, in the selection of patients and adjustment of dosage.

Fluorouracil should be used with caution in patients with reduced renal or liver function or jaundice. Isolated cases of angina, ECG abnormalities and rarely, myocardial infarction have been reported following administration of Fluorouracil. Caution should therefore be exercised in treating patients who experience chest pain during courses of treatment, or patients with a history of heart disease.

There have been reports of increased toxicity in patients who have reduced activity/deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Various agents have been reported to biochemically modulate the antitumour efficacy or toxicity of Fluorouracil, common drugs include Methotrexate, Metronidazole, Leucovorin as well as Allopurinol and Cimetidine which can affect the availability of the active drug.

Marked elevations of prothrombin time and INR have been reported in a few patients stabilised on warfarin therapy following initiation of fluorouracil regimes.

A clinically significant interaction between the antiviral sorivudine and fluorouracil prodrugs, resulting from inhibition of dihydropyrimidine dehydrogenase by sorivudine or chemically related analogues. Caution should be taken when using Fluorouracil in conjunction with medications which may affect dihydropyrimidine dehydrogenase activity.

4.6 Pregnancy And Lactation

Fluorouracil is strictly contraindicated in pregnant or breast feeding women.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Diarrhoea, nausea and vomiting are observed quite commonly during therapy and may be treated symptomatically. An anti-emetic may be given for nausea and vomiting.

Alopecia may be seen in a substantial number of cases particularly in females, but is reversible. Other side effects Include dermatitis, pigmentation, changes in the nails , ataxia and fever.

There have been reports of chest pain, tachycardia ,breathlessness and ECG changes after administration of fluorouracil. Special attention is therefore advisable in treating patients with a history of heart disease or those who develop chest pain during treatment.

Systemic fluorouracil treatment has been associated with various types of ocular toxicity. Peripheral neuropathy may occur.

A transient reversible cerebellar syndrome has been reported following fluorouracil treatment. Rarely, a reversible confusional state may occur. Cases of leucoencephalopathy have also been reported.

Additionally several other reports have been noted including:

Incidences of excessive lacrimation, dacryostenosis, visual changes and photophobia.

Palmar-plantar erythrodysesthesia syndrome has been reported as an unusual complication of high dose bolus or protracted continuous therapy for 5-fluorouracil.

4.9 Overdose

The symptoms and signs of overdosage are qualitatively similar to the adverse reactions and should be managed as indicated under "Special Warnings and Precautions and " Undesirable Effects".

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Fluorouracil is an analogue of uracil, a component of ribonucleic acid. The drug is believed to function as an antimetabolite. After intracellular conversion to the active deoxynucleotide, it interferes with the synthesis of DNA by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase. Fluorouracil may also interfere with RNA synthesis.

5.2 Pharmacokinetic Properties

After intravenous administration, fluorouracil is distributed through the body water and disappears from the blood within 3 hours. It is preferentially taken up by actively dividing tissues and tumours after conversion to its nucleotide. Fluorouracil readily enters the C.S.F. and brain tissue.

Following I.V. administration, the plasma elimination half-life averages about 16 minutes and is dose dependent. Following a single I.V. dose of Fluorouracil approximately 15% of the dose is excreted unchanged in the urine within 6 hours; over 90% of this is excreted in the first hour. The remainder is mostly metabolised in the liver by the usual body mechanisms for uracil.

5.3 Preclinical Safety Data

Preclinical information has not been included because the toxicity profile of fluorouracil has been established after many years of clinical use. Please refer to section 4.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide

Water for Injections.

6.2 Incompatibilities

5-Fluorouracil is incompatible with Carboplatin, Cisplatin, Cytarabine. Diazepam, Doxorubicin, other Anthracyclines and possibly Methotrexate.

Formulated solutions are alkaline and it is recommended that admixture with acidic drugs or preparations should be avoided.

6.3 Shelf Life

Before use: 24 months

In use: Chemical and physical in-use stability has been demonstrated for 5 days at 20-21°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

Do not store above 25°C. Do not refrigerate or freeze. Keep container in the outer carton.

The pH of fluorouracil injection is 8.9 and the drug has maximal stability over the pH range 8.6 to 9.0.

If a precipitate has formed as a result of exposure to low temperatures, redissolve by heating to 60°C accompanied by vigorous shaking. Allow to cool to body temperature prior to use.

The product should be discarded if it appears brown or dark yellow in solution.

6.5 Nature And Contents Of Container

Type I Conventional Clear Glass Vials with rubber closures.

Type I Clear Onco-Tain® Vials with rubber closures.

250 mg/10ml: Pack Size 5.

500 mg/20ml: Pack Size 10.

2.5 g/100 ml: Pack Size Singles and 10's.

Not all presentations or pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Cytotoxic Handling Guidelines

Should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.

Fluorouracil Injection should only be prepared for administration by professionals who have been trained in the safe use of the preparation. Preparation should only be carried out in an aseptic cabinet or suite dedicated for the assembly of cytotoxics.

In the event of spillage, operators should put on gloves, face mask, eye protection and disposable apron and mop up the spilled material with a absorbent material kept in the area for that purpose. The area should then be cleaned and all contaminated material transferred to a cytotoxic spillage bag or bin and sealed for incineration.

Contamination

Fluorouracil is an irritant, contact with skin and mucous membranes should be avoided.

In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat the transient stinging of the skin. Medical advice should be sought if the eyes are affected or if the preparation is inhaled or ingested.

Please refer to company for COSHH hazard datasheets.

Preparation Guidelines

a) Chemotherapeutic agents should be prepared for administration only by professionals who have been trained in the safe use of the preparation.

b) Operations such as reconstitution of powder and transfer to syringes should be carried out only under aseptic conditions in a suite or cabinet dedicated for the assembly of cytotoxics.

c) The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield.

d) Pregnant personnel are advised not to handle chemotherapeutic agents.

Disposal

Syringes, Onco•Vials® and adaptors containing remaining solution, absorbent materials, and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerated at 700°C.

Diluents

Fluorouracil Injection may be diluted with Glucose 5% Injection or Sodium Chloride 0.9% Injection or Water for Injections immediately before parenteral use.

7. Marketing Authorisation Holder

Hospira UK Limited

Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW

United Kingdom.

8. Marketing Authorisation Number(S)

PL 04515/0024

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 20 August 1985

Renewal of Authorisation: 19 July 2004

10. Date Of Revision Of The Text

12 August 2011


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Helium



Helium, COMPRESSED        

Helium, COMPRESSED

UN1046

USP

NON-FLAMMABLE GAS 2

MEDICAL GAS

Rx only

Linde

WARNING: Administration of Helium may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Helium and is familiar with the indications, effect, dosages, methods and frequency and duration of administration, and the hazards, methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken. When used as a diluent for oxygen to produce respirable mixtures, user must assure sufficient oxygen concentration to sustain life.

CAUTION: HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION. Open valve slowly and close after each use. Keep away from heat, flame or sparks. Do not strike arc or laser beam on cylinder. Transport, store, and use with adequate ventilation. Use equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52°C (125°F). Always secure cylinder in upright position. Return cylinder with 25 psig pressure. Return cylinder with cylinder cap secured, if applicable. Use this product in accordance with it's specific Material Safety Data Sheet, available at Web Site: www.lindeus.com. FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is is difficult, give oxygen. Call a physician.

DO NOT REMOVE THIS PRODUCT LABEL.

CONTENTS: Cylinder
Type Liters    K 5688 [_] M 2830 [_] _______ _______ _______

Distributed by:
Linde Gas North America LLC
Linde
575 Mountain Ave.
Murray Hill, NJ 07974

CAS 7440-59-7

L&SP 4014 MG006D


Helium  
Helium  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25373-010 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Helium (Helium) Helium 99 L  in 100 L Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 25373-010-04 5688 L In 1 CYLINDER None 2 25373-010-05 2830 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 11/27/1990
Labeler - Linde Gas North America LLC (805568339) Establishment Name Address ID/FEI Operations Linde Gas North America LLC 010263301 MANUFACTURE Revised: 12/2011Linde Gas North America LLC

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EZ-OX Plus


Generic Name: oxygen
Dosage Form: gas
EZ-OX Plus COMPRESSED OXYGEN USP


Enter section text here




Enter section text here

WARNING: CYLINDER WITH HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION.  Secure cylinder and provide adequate ventilation in storage and use.  Keep oil and grease away.  No smoking in cylinder area.  Do not use or store near heat or open flame.  Keep out of reach of children.  Use only with equipment cleaned for oxygen service and rated for cylinder pressure.  Cylinder temperature should not exceed 125°F(52°C).  Use in accordance with Material Safety Data Sheet and CGA Publication p-1.  WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.  For all other medical applications Rx ONLY.  Uninterrupted use of high concentrations of oxygen over a long duration without monitoring its effect on oxygen content of arterial blood, may be harmful.  Use only with pressure reducing equipment and apparatus designed for oxygen.  Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitating equipment.  CAUTION: Federal law prohibits dispensing without prescription.  Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug producer in accordance with the Federal Food, Drug, and Cosmetic Act.  Produced by Air Liquefaction.  CAUTION: USE NO OIL ON VALVE OR CONNECTIONS.  DO NOT REMOVE THIS EZ-OX PRODUCT LABEL.
EZ-OX Plus 
oxygen  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64735-101 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (Oxygen) Oxygen 99 L  in 100 L Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 64735-101-04 708 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1960
Labeler - Air Liquide Healthcare America Corporation (087757167) Establishment Name Address ID/FEI Operations Air Liquide Healthcare America Corporation 067631762 manufacture Establishment Name Address ID/FEI Operations Air Liquide Healthcare America Corporation 831996520 manufacture Establishment Name Address ID/FEI Operations Air Liquide Healthcare America Corporation 026523431 manufacture Establishment Name Address ID/FEI Operations Air Liquide Healthcare America Corporation 023215130 manufacture Establishment Name Address ID/FEI Operations Air Liquide Healthcare America Corporation 808357268 manufacture Establishment Name Address ID/FEI Operations Air Liquide Healthcare America Corporation 963593863 manufacture Revised: 10/2010Air Liquide Healthcare America Corporation
More EZ-OX Plus resources EZ-OX Plus Drug Interactions EZ-OX Plus Support Group 0 Reviews · Be the first to review/rate this drug
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Methotrexate Injection


1. Name Of The Medicinal Product

Methotrexate Injection 5mg/2ml., Methotrexate Injection 25 mg/ml and Methotrexate Injection 100 mg/ml

2. Qualitative And Quantitative Composition

Active Constituent

 

 

5 mg/2 ml

25 mg/ml

100 mg/ml

Methotrexate

Ph Eur

5 mg

25 mg

100 mg

Other Constituents

 

 

 

 

 

 

 

 

Sodium Chloride

BP

17.2 mg

4.9 mg

None

Sodium Hydroxide

BP

QS

QS

QS

Water for Injections

BP

To 2 ml

To 1 ml

To 1 ml

There is a 5 % manufacturing overage included in the formulation.

3. Pharmaceutical Form

Sterile solution of Methotrexate in Water for Injections.

4. Clinical Particulars 4.1 Therapeutic Indications

Methotrexate is indicated in the treatment of neoplastic disease, such as trophoblastic neoplasms and leukaemia, and the symptomatic treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy.

Methotrexate Injection B.P. may be given by the intramuscular, intravenous, intra-arterial, intrathecal routes.

Note: Methotrexate Injection B.P, 1g /10ml and 5g /50ml presentations are hypertonic and therefore are not suitable for intrathecal use. In addition, the 500mg/20ml and 1g/40ml presentations are not suitable for intrathecal use

4.2 Posology And Method Of Administration

Adults and children

Antineoplastic Chemotherapy

Methotrexate is active orally and parenterally. Methotrexate Injection B.P. may be given by the intramuscular, intravenous, intra-arterial or intrathecal routes. Dosage is related to the patient's body weight or surface area. Methotrexate has been used with beneficial effect in a wide variety of neoplastic diseases, alone and in combination with other cytotoxic agents.

Note: Methotrexate Injection B.P, 1g /10ml and 5g /50ml presentations are hypertonic and therefore are not suitable for intrathecal use. In addition, the 500mg/20ml and 1g/40ml presentations are not suitable for intrathecal use

Choriocarcinoma and Similar Trophoblastic Diseases

Methotrexate is administered orally or intramuscularly in doses of 15-30mg daily for a 5 day course. Such courses may be repeated 3-5 times as required, with rest periods of one or more weeks interposed between courses until any manifesting toxic symptoms subside.

The effectiveness of therapy can be evaluated by 24 hours quantitative analysis of urinary chorionic gonadotrophin hormone (HCG). Combination therapy with other cytotoxic drugs, has also been reported as useful.

Hydatidiform mole may precede or be followed by choriocarcinoma, and Methotrexate has been used in similar doses for the treatment of hydatidiform mole and chorioadenoma destruens.

Breast Carcinoma

Prolonged cyclic combination with Cyclophosphamide, Methotrexate and Fluorouracil has given good results when used as adjuvant treatment to radical mastectomy in primary breast cancer with positive axillary lymph nodes. Methotrexate dosage was 40mg/m2 intravenously on the first and eighth days.

Leukaemia

Acute granulocytic leukaemia is rare in children but common in adults and this form of leukaemia responds poorly to chemotherapy.

Methotrexate is not generally a drug of choice for induction of remission of lymphoblastic leukaemia. Oral Methotrexate dosage 3.3mg/m2 daily, and Prednisolone 40-60mg/m2 daily for 4-6 weeks has been used. After a remission is attained, Methotrexate in a maintenance dosage of 20-30mg/m2 orally or by I.M. injection has been administered twice weekly. Twice weekly doses appear to be more effective than daily drug administration. Alternatively, 2.5mg/kg has been administered I.V. every 14 days.

Meningeal Leukaemia

Some patients with leukaemia are subject to leukaemic invasions of the central nervous system and the CSF should be examined in all leukaemia patients.

Passage of Methotrexate from blood to the cerebrospinal fluid is minimal and for adequate therapy the drug should be administered intrathecally. Methotrexate may be given in a prophylactic regimen in all cases of lymphocytic leukaemia. Methotrexate is administered by intrathecal injection in doses of 200-500 microgram/kg body weight. The administration is at intervals of 2 to 5 days and is usually repeated until the cell count of cerebrospinal fluid returns to normal. At this point one additional dose is advised. Alternatively, Methotrexate 12mg/m2 can be given once weekly for 2 weeks, and then once monthly. Large doses may cause convulsions and untoward side effects may occur as with any intrathecal injection, and are commonly neurological in character.

Note: Methotrexate Injection B.P, 1g /10ml and 5g /50ml presentations are hypertonic and therefore are not suitable for intrathecal use. In addition, the 500mg/20ml and 1g/40ml presentations are not suitable for intrathecal use.

Lymphomas

In Burkitt's Tumour, stages 1-2, Methotrexate has prolonged remissions in some cases. Recommended dosage is 10-25mg per day orally for 4 to 8 days. In stage 3, Methotrexate is commonly given concomitantly with other antitumour agents. Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods, and in stage 3 they respond to combined drug therapy with Methotrexate given in doses of 0.625mg to 2.5mg/kg daily. Hodgkin's Disease responds poorly to Methotrexate and to most types of chemotherapy.

Mycosis Fungoides

Therapy with Methotrexate appears to produce clinical remissions in one half of the cases treated. Recommended dosage is usually 2.5 to 10mg daily by mouth for weeks or months and dosage should be adjusted according to the patient's response and haematological monitoring. Methotrexate has also been given intramuscularly in doses of 50mg once weekly or 25mg twice weekly.

Psoriasis Chemotherapy

Cases of severe uncontrolled psoriasis, unresponsive to conventional therapy, have responded to weekly single, oral, I.M. or I.V. doses of 10-25mg per week, and adjusted according to the patient's response. An initial test dose one week prior to initiation of therapy is recommended to detect any idiosyncrasy. A suggested dose range is 5-10mg.

An alternative dosage schedule consists of 2.5 to 5mg of Methotrexate administered orally at 12 hour intervals for 3 doses each week or at 8-hour intervals for 4 doses each week; weekly dosages should not exceed 30mg.

A daily oral dosage schedule of 2 to 5mg administered orally for 5 days followed by a rest period of at least 2 days may also be used. The daily dose should not exceed 6.25mg.

The patient should be fully informed of the risks involved and the clinician should pay particular attention to the appearance of liver toxicity by carrying out liver function tests before starting Methotrexate treatment, and repeating these at 2 to 4 month intervals during therapy. The aim of therapy should be to reduce the dose to the lowest possible level with the longest possible rest period. The use of Methotrexate may permit the return to conventional topical therapy which should be encouraged.

4.3 Contraindications

Significantly impaired renal function.

Significantly impaired hepatic function

Pre-existing blood dyscrasias, such as significant marrow hypoplasia, leukopenia, thrombocytopenia or anaemia.

Methotrexate is contraindicated in pregnancy.

Because of the potential for serious adverse reactions from methotrexate in breast fed infants, breast feeding is contra-indicated in women taking methotrexate.

Patients with a known allergic hypersensitivity to methotrexate should not receive methotrexate.

4.4 Special Warnings And Precautions For Use

WARNINGS

Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy.

Because of the possibility of fatal or severe toxic reactions, the patient should be fully informed by the physician of the risks involved and be under his constant supervision.

Deaths have been reported with the use of Methotrexate in the treatment of psoriasis.

In the treatment of psoriasis, Methotrexate should be restricted to severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established by biopsy and/or after dermatological consultation.

1. Full blood counts should be closely monitored before, during and after treatment. If a clinically significant drop in white-cell or platelet count develops, methotrexate should be withdrawn immediately. Patients should be advised to report all symptoms or signs suggestive of infection.

2. Methotrexate may be hepatotoxic, particularly at high dosage or with prolonged therapy. Liver atrophy, necrosis, cirrhosis, fatty changes, and periportal fibrosis have been reported. Since changes may occur without previous signs of gastrointestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy. If substantial hepatic function abnormalities develop, methotrexate dosing should be suspended for at least 2 weeks.Special caution is indicated in the presence of pre-existing liver damage or impaired hepatic function. Concomitant use of other drugs with hepatotoxic potential (including alcohol) should be avoided.

3. Methotrexate has been shown to be teratogenic; it has caused foetal death and/or congenital anomalies. Therefore it is not recommended in women of childbearing potential unless there is appropriate medical evidence that the benefits can be expected to outweigh the considered risks. Pregnant psoriatic patients should not receive Methotrexate.

4. Renal function should be closely monitored before, during and after treatment. Caution should be exercised if significant renal impairment is disclosed. Reduce dose of methotrexate in patients with renal impairment. High doses may cause the precipitation of methotrexate or its metabolites in the renal tubules. A high fluid throughput and alkalinisation of the urine to pH 6.5 – 7.0, by oral or intravenous administration of sodium bicarbonate (5 x 625mg tablets every three hours) or acetazolamide (500mg orally four times a day) is recommended as a preventative measure . Methotrexate is excreted primarily by the kidneys. Its use in the presence of impaired renal function may result in accumulation of toxic amounts or even additional renal damage.

5. Diarrhoea and ulcerative stomatitis are frequent toxic effects and require interruption of therapy, otherwise haemorrhagic enteritis and death from intestinal perforation may occur.

6. Methotrexate affects gametogenesis during the period of its administration and may result in decreased fertility which is thought to be reversible on discontinuation of therapy. Conception should be avoided during the period of Methotrexate administration and for at least 6 months thereafter. Patients and their partners should be advised to this effect.

7. Methotrexate has some immunosuppressive activity and immunological responses to concurrent vaccination may be decreased. The immunosuppressive effect of Methotrexate should be taken into account when immune responses of patients are important or essential.

8. Pleural effusions and ascites should be drained prior to initiation of methotrexate therapy.

9. Deaths have been reported with the use of methotrexate. Serious adverse reactions including deaths have been reported with concomitant administration of methotrexate (usually in high doses) along with some non-steroidal anti-inflammatory drugs (NSAIDs).

10. Concomitant administration of folate antagonists such as trimethoprim/sulphamethoxazole has been reported to cause an acute megaloblastic pancytopenia in rare instances.

11. Systemic toxicity may occur following intrathecal administration. Blood counts should be monitored closely.

12. A chest X-ray is recommended prior to initiation of methotrexate therapy.

13. If acute methotrexate toxicity occurs, patients may require folinic acid.

PRECAUTIONS

Methotrexate has a high potential toxicity, usually dose related, and should be used only by physicians experienced in antimetabolite chemotherapy, in patients under their constant supervision. The physician should be familiar with the various characteristics of the drug and its established clinical usage.

Before beginning methotrexate therapy or reinstituting methotrexate after a rest period, assessment of renal function, liver function and blood elements should be made by history, physical examination and laboratory tests.

It should be noted that intrathecal doses are transported into the cardiovascular system and may give rise to systemic toxicity. Systemic toxicity of methotrexate may also be enhanced in patients with renal dysfunction, ascites, or other effusions due to prolongation of serum half-life.

Carcinogenesis, mutagenesis, and impairment of fertility: Animal carcinogenicity studies have demonstrated methotrexate to be free of carcinogenic potential. Although methotrexate has been reported to cause chromosomal damage to animal somatic cells and bone marrow cells in humans, these effects are transient and reversible. In patients treated with methotrexate, evidence is insufficient to permit conclusive evaluation of any increased risk of neoplasia.

Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans, during and for a short period after cessation of therapy. In addition, methotrexate causes, embryotoxicity, abortion and foetal defects in humans. Therefore the possible risks of effects on reproduction should be discussed with patients of childbearing potential (see 'Warnings').

Patients undergoing therapy should be subject to appropriate supervision so that signs or symptoms of possible toxic effects or adverse reactions may be detected and evaluated with minimal delay. Pretreatment and periodic haematological studies are essential to the use of Methotrexate in chemotherapy because of its common effect of haematopoietic suppression. This may occur abruptly and on apparent safe dosage, and any profound drop in blood cell count indicates immediate stopping of the drug and appropriate therapy. In patients with malignant disease who have pre-existing bone marrow aplasia, leukopenia, thrombocytopenia or anaemia, methotrexate should be used with caution, if at all.

In general, the following laboratory tests are recommended as part of essential clinical evaluation and appropriate monitoring of patients chosen for or receiving Methotrexate therapy: complete haemogram; haematocrit; urinalysis; renal function tests; liver function tests and chest X-ray.

The purpose is to determine any existing organ dysfunction or system impairment. The tests should be performed prior to therapy, at appropriate periods during therapy and after termination of therapy.

Liver biopsy may be considered after cumulative doses> 1.5g have been given, if hepatic impairment is suspected.

Methotrexate is bound in part to serum albumin after absorption, and toxicity may be increased because of displacement by certain drugs such as salicylates, sulphonamides, phenytoin, and some antibacterials such as tetracycline, chloramphenicol and para-aminobenzoic acid. These drugs, especially salicylates and sulphonamides, whether antibacterial, hypoglycaemic or diuretic, should not be given concurrently until the significance of these findings is established.

Vitamin preparations containing folic acid or its derivatives may alter response to Methotrexate.

Methotrexate should be used with extreme caution in the presence of infection, peptic ulcer, ulcerative colitis, debility, and in extreme youth and old age. If profound leukopenia occurs during therapy, bacterial infection may occur or become a threat. Cessation of the drug and appropriate antibiotic therapy is usually indicated. In severe bone marrow depression, blood or platelet transfusions may be necessary.

Since it is reported that Methotrexate may have an immunosuppressive action, this factor must be taken into consideration in evaluating the use of the drug where immune responses in a patient may be important or essential.

In all instances where the use of Methotrexate is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risks of toxic effects or adverse reactions. Most such adverse reactions are reversible if detected early. When such effects or reactions do occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgement of the physician. Reinstitution of Methotrexate therapy should be carried out with caution, with adequate consideration of further need for the drug and alertness as to the possible recurrence of toxicity.

Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Methotrexate is extensively protein bound and may be displaced by certain drugs such as salicylates, hypoglycaemics, diuretics, sulphonamides, diphenylhydantoins, tetracyclines, chloramphenicol and p-aminobenzoic acid, and the acidic anti-inflammatory agents, so causing a potential for increased toxicity when used concurrently.

Concomitant use of other drugs with nephrotoxic or hepatotoxic potential (including alcohol) should be avoided.

Vitamin preparations containing folic acid or its derivatives may decrease the effectiveness of methotrexate.

Caution should be used when NSAIDs and salicylates are administered concomitantly with methotrexate. These drugs have been reported to reduce the tubular secretion of methotrexate and thereby may enhance its toxicity. Concomitant use of NSAIDs and salicylates has been associated with fatal methotrexate toxicity.

However, patients using constant dosage regimens of NSAIDs have received concurrent doses of methotrexate without problems observed.

Renal tubular transport is also diminished by probenecid and penicillins; use of these with methotrexate should be carefully monitored.

Severe bone marrow depression has been reported following the concurrent use of methotrexate and co-trimoxazole or trimethoprim. Concurrent use should probably be avoided.

Methotrexate-induced stomatitis and other toxic effects may be increased by the use of nitrous oxide.

An increased risk of hepatitis has been reported following the use of methotrexate and the acitretin metabolite, etretinate. Consequently, the concomitant use of methotrexate and acitretin should be avoided.

4.6 Pregnancy And Lactation

Abortion, foetal death, and/or congenital anomalies have occurred in pregnant women receiving Methotrexate, especially during the first trimester of pregnancy. Methotrexate is contraindicated in the management of psoriasis or rheumatoid arthritis in pregnant women. Women of childbearing potential should not receive Methotrexate until pregnancy is excluded. For the management of psoriasis or rheumatoid arthritis, Methotrexate therapy in women should be started immediately following a menstrual period and appropriate measures should be taken in men or women to avoid conception during and for at least 6 months following cessation of Methotrexate therapy.

Both men and women receiving Methotrexate should be informed of the potential risk of adverse effects on reproduction. Women of childbearing potential should be fully informed of the potential hazard to the foetus should they become pregnant during Methotrexate therapy. In cancer chemotherapy, Methotrexate should not be used in pregnant women or women of childbearing potential who might become pregnant unless the potential benefits to the mother outweigh the possible risks to the foetus.

Defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, and infertility have been reported in patients receiving Methotrexate.

Methotrexate is distributed into breast milk. Because of the potential for serious adverse reactions to Methotrexate in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

The most common adverse reactions include ulcerative stomatitis, leukopenia, nausea and abdominal distress. Although very rare, anaphylactic reactions to methotrexate have occurred. Others reported are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection. In general, the incidence and severity of side effects are considered to be dose-related. Adverse reactions as reported for the various systems are as follows:

Skin: Stevens-Johnson syndrome, epidermal necrolysis, erythematous rashes, pruritus, urticaria, photosensitivity, pigmentary changes, alopecia, ecchymosis, telangiectasia, acne, furunculosis. Lesions of psoriasis may be aggravated by concomitant exposure to ultraviolet radiation. Skin ulceration in psoriatic patients and rarely painful erosion of psoriatic plaques have been reported. The recall phenomenon has been reported in both radiation and solar damaged skin.

Blood: Bone marrow depression, leukopenia, thrombocytopenia, anaemia, hypogammaglobulinaemia, haemorrhage from various sites, septicaemia.

Alimentary System: Gingivitis, pharyngitis, stomatitis, anorexia, vomiting, diarrhoea, haematemesis, melaena, gastrointestinal ulceration and bleeding, enteritis, hepatic toxicity resulting in active liver atrophy, necrosis, fatty metamorphosis, periportal fibrosis, or hepatic cirrhosis. In rare cases the effect of methotrexate on the intestinal mucosa has led to malabsorption or toxic megacolon.

Hepatic: Hepatic toxicity resulting in significant elevations of liver enzymes, acute liver atrophy, necrosis, fatty metamorphosis, periportal fibrosis or cirrhosis or death may occur, usually following chronic administration.

Urogenital System: Renal failure, azotaemia, cystitis, haematuria, defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, infertility, abortion, foetal defects, severe nephropathy. Vaginitis, vaginal ulcers, cystitis, haematuria and nephropathy have also been reported.

Pulmonary System: Infrequently an acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported. Acute pulmonary oedema has also been reported after oral and intrathecal use. Pulmonary fibrosis is rare. A syndrome consisting of pleuritic pain and pleural thickening has been reported following high doses.

Central Nervous System: Headaches, drowsiness, blurred vision, aphasia, hemiparesis and convulsions have occurred possibly related to haemorrhage or to complications from intra-arterial catheterization. Convulsion, paresis, Guillain-Barre syndrome and increased cerebrospinal fluid pressure have followed intrathecal administration.

Other reactions related to, or attributed to the use of Methotrexate such as pneumonitis, metabolic changes, precipitation of diabetes, osteoporotic effects, abnormal changes in tissue cells and even sudden death have been reported.

There have been reports of leukoencephalopathy following intravenous methotrexate in high doses, or low doses following cranial-spinal radiation.

Adverse reactions following intrathecal methotrexate are generally classified into three groups, acute, subacute, and chronic. The acute form is a chemical arachnoiditis manifested by headache, back or shoulder pain, nuchal rigidity, and fever. The subacute form may include paresis, usually transient, paraplegia, nerve palsies, and cerebellar dysfunction. The chronic form is a leukoencephalopathy manifested by irritability, confusion, ataxia, spasticity, occasionally convulsions, dementia, somnolence, coma, and rarely, death. There is evidence that the combined use of cranial radiation and intrathecal methotrexate increases the incidence of leukoencephalopathy.

Additional reactions related to or attributed to the use of methotrexate such as osteoporosis, abnormal (usually 'megaloblastic') red cell morphology, precipitation of diabetes, other metabolic changes, and sudden death have been reported.

4.9 Overdose

Calcium Folinate (Calcium Leucovorin) is a potent agent for neutralizing the immediate toxic effects of Methotrexate on the haematopoietic system. Where large doses or overdoses are given, Calcium Folinate may be administered by intravenous infusion in doses up to 75mg within 12 hours, followed by 12mg intramuscularly every 6 hours for 4 doses. Where average doses of Methotrexate appear to have an adverse effect 6-12mg of Calcium Folinate may be given intramuscularly every 6 hours for 4 doses. In general, where overdosage is suspected, the dose of Calcium Folinate should be equal to or higher than, the offending dose of Methotrexate and should be administered as soon as possible; preferably within the first hour and certainly within 4 hours after which it may not be effective.

Other supporting therapy such as blood transfusion and renal dialysis may be required. Effective clearance of methotrexate has been reported with acute, intermittent haemodialysis using a high flux dialyser.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Methotrexate is an antimetabolite which acts principally by competitively inhibiting the enzyme, dihydrofolate reductase. In the process of DNA synthesis and cellular replication, folic acid must be reduced to tetrahydrofolic acid by this enzyme, and inhibition by Methotrexate interferes with tissue cell reproduction. Actively proliferating tissues such as malignant cells are generally more sensitive to this effect of Methotrexate. It also inhibits antibody synthesis.

Methotrexate also has immunosuppressive activity, in part possibly as a result of inhibition of lymphocyte multiplication. The mechanism(s) of action in the management of rheumatoid arthritis of the drug is not known, although suggested mechanisms have included immunosuppressive and/or anti-inflammatory effect.

5.2 Pharmacokinetic Properties

In doses of 0.1mg (of Methotrexate) per kg, Methotrexate is completely absorbed from the G.I. tract; larger oral doses may be incompletely absorbed. Peak serum concentrations are achieved within 0.5 - 2 hours following I.V. / I.M. or intra-arterial administration. Serum concentrations following oral administration of Methotrexate may be slightly lower than those following I.V. injection.

Methotrexate is actively transported across cell membranes. The drug is widely distributed into body tissues with highest concentrations in the kidneys, gall bladder, spleen, liver and skin. Methotrexate is retained for several weeks in the kidneys and for months in the liver. Sustained serum concentrations and tissue accumulation may result from repeated daily doses. Methotrexate crosses the placental barrier and is distributed into breast milk. Approximately 50% of the drug in the blood is bound to serum proteins.

In one study, Methotrexate had a serum half-life of 2-4 hours following I.M. administration. Following oral doses of 0.06mg/kg or more, the drug had a serum half-life of 2-4 hours, but the serum half-life was reported to be increased to 8-10 hours when oral doses of 0.037mg/kg were given.

Methotrexate does not appear to be appreciably metabolised. The drug is excreted primarily by the kidneys via glomerular filtration and active transport. Small amounts are excreted in the faeces, probably via the bile. Methotrexate has a biphasic excretion pattern. If Methotrexate excretion is impaired accumulation will occur more rapidly in patients with impaired renal function. In addition, simultaneous administration of other weak organic acids such as salicylates may suppress Methotrexate clearance.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Other Constituents

 

 

5 mg/2 ml

25 mg/ml

100 mg/ml

Sodium Chloride

BP

17.2 mg

4.9 mg

None

Sodium Hydroxide

BP

QS

QS

QS

Water for Injections

BP

To 2 ml

To 1 ml

To 1 ml

There is a 5 % manufacturing overage included in the formulation.

6.2 Incompatibilities

Immediate precipitation or turbidity results when combined with certain concentrations of

Droperidol, Heparin Sodium, Metoclopramide Hydrochloride, Ranitidine

Hydrochloride in syringe.

6.3 Shelf Life

5 mg/2 ml and 25 mg/ml – 24 months

100 mg/ ml - 30 months

6.4 Special Precautions For Storage

For the 1g/40ml presentation : Store between 2-8°C. Protect from light.

For all other prersentations: Store below 25°C. Protect from light and freezing.

Unused portions of opened vials must not be stored and should be discarded immediately. Prepared infusions, not used immediately, must be stored at 2-8°C for no longer than 24 hours from the time of preparation.

6.5 Nature And Contents Of Container

Conventional Glass Vials (5 mg/ 2 ml, 50mg/2ml, 250mg/10ml, 500mg/20ml, 1 g/10 ml and 5 g/50 ml):

Type I glass vial, 2ml, 13mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in packs of 5 vials.

Type I glass vial, 10ml, 13mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in packs of 5 vials.

Type I glass vial, 20ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Type I glass vial, 10ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Type I glass vial, 50ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Onco-TainTM Vials (5 mg/2 ml, 50mg/2ml, 500mg/20ml, 1 g/10 ml and 5 g/50 ml only):

Clear Type I Onco-TainTM vial, 2ml, 13mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in packs of 5 vials.

Clear Type I Onco-TainTM vial, 20ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Clear Type I Onco-TainTM vial, 10ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Clear Type I Onco-TainTM vial, 50ml, 20mm, 1704 rubber closure, aluminium seal with plastic 'flip-off' top in single vial packs.

Onco-Vial TM (Shell Glass Vials )(500mg/20ml, 1g/40ml, 1 g/10 ml and 5 g/ 50 ml only):

Clear Type I shell glass vial, 10ml, 15mm, west type 4405/50 rubber closure in single vial packs.

Clear Type I shell glass vial, 50ml, 27mm, west type 4405/50 rubber closure in single vial packs.

Clear Type I shell glass vial, 50ml, 27mm, west type 4416/50 rubber closure in single vial packs.

Not all presentations and pack sizes listed above may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Faulding Pharmaceuticals Plc

Queensway

Royal Leamington Spa

Warwickshire, CV31 3RW

8. Marketing Authorisation Number(S)

5 mg/2 ml presentation: PL 04515/0013

25 mg/ml presentation: PL 04515/0015

100 mg/ml presentation: PL 04515/0038

9. Date Of First Authorisation/Renewal Of The Authorisation

21st August 1985/11th March 1996

10. Date Of Revision Of The Text

12th July 2000


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Methotrexate 100 mg / ml Injection (Hospira UK Ltd)


1. Name Of The Medicinal Product

Methotrexate 100 mg/ml Injection

2. Qualitative And Quantitative Composition

Each ml of solution contains 100 mg methotrexate (sodium salt formed in situ)

Each vial of 10 ml of solution contains 1 g methotrexate (sodium salt formed in situ)

Each vial of 50 ml of solution contains 5 g methotrexate (sodium salt formed in situ)

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for Injection

Vials containing a clear yellow/orange solution

4. Clinical Particulars 4.1 Therapeutic Indications

Methotrexate is indicated in the treatment of neoplastic disease, such as trophoblastic neoplasms and leukaemia, and the symptomatic treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy.

Methotrexate Injection B.P. may be given by the intramuscular, intravenous, intraarterial, intrathecal routes.

NOTE: Methotrexate Injection 1 g/10 ml and 5 g/50 ml are hypertonic and therefore are not suitable for intrathecal use. The 500 mg/20 ml should not be administered by the intrathecal route.

4.2 Posology And Method Of Administration

Adults and children

Antineoplastic Chemotherapy

Methotrexate is active orally and parenterally. Methotrexate Injection B.P. may be given by the intramuscular, intravenous, intraarterial or intrathecal routes. Dosage is related to the patient's body weight or surface area. Methotrexate has been used with beneficial effect in a wide variety of neoplastic diseases, alone and in combination with other cytotoxic agents.

Note:Methotrexate Injection 1 g in 10 ml and 5 g in 50 ml are hypertonic and thus it is not recommended for intrathecal use.

Choriocarcinoma and Similar Trophoblastic Diseases

Methotrexate is administered orally or intramuscularly in doses of 15-30 mg daily for a 5 day course. Such courses may be repeated 3-5 times as required, with rest periods of one or more weeks interposed between courses until any manifesting toxic symptoms subside.

The effectiveness of therapy can be evaluated by 24 hours quantitative analysis of urinary chorionic gonadotrophin hormone (HCG). Combination therapy with other cytotoxic drugs, has also been reported as useful.

Hydatidiform mole may precede or be followed by choriocarcinoma, and methotrexate has been used in similar doses for the treatment of hydatidiform mole and chorioadenoma destruens.

Breast Carcinoma

Prolonged cyclic combination with cyclophosphamide, methotrexate and fluorouracil has given good results when used as adjuvant treatment to radical mastectomy in primary breast cancer with positive axillary lymph nodes. Methotrexate dosage was 40 mg/m2 intravenously on the first and eighth days.

Leukaemia

Acute granulocytic leukaemia is rare in children but common in adults and this form of leukaemia responds poorly to chemotherapy.

Methotrexate is not generally a drug of choice for induction of remission of lymphoblastic leukaemia. Oral methotrexate 3.3 mg/m2 daily, and prednisolone 40-60 mg/m2 daily for 4-6 weeks has been used. After a remission is attained, methotrexate in a maintenance dosage of 20-30 mg/m2 orally or by I.M. injection has been administered twice weekly. Twice weekly doses appear to be more effective than daily drug administration. Alternatively, 2.5 mg/kg has been administered I.V. every 14 days.

Meningeal Leukaemia

Some patients with leukaemia are subject to leukaemic invasions of the central nervous system and the CSF should be examined in all leukaemia patients.

Passage of methotrexate from blood to the cerebrospinal fluid is minimal and for adequate therapy the drug should be administered intrathecally. Methotrexate may be given in a prophylactic regimen in all cases of lymphocytic leukaemia. The dose of intrathecal Methotrexate is constant regardless of age or body surface area in patients over the age of 3 years of age, the maximum intrathecal dose should be 12 mg in such patients. Patients under the age of 3 years should be treated in accordance with combination chemotherapy protocols. The administration is at weekly intervals and is usually repeated until the cell count of cerebrospinal fluid returns to normal. At this point one additional dose is advised. Large doses may cause convulsions and untoward side effects may occur as with any intrathecal injection, and are commonly neurological in character.

NOTE: Methotrexate Injection 1 g in 10 ml and 5 g in 50 ml are not recommended for intrathecal use and the 500 mg/20 ml is not recommended for intrathecal use.

Lymphomas

In Burkitt's Tumour, stages 1-2, methotrexate has prolonged remissions in some cases. Recommended dosage is 10-25 mg per day orally for 4 to 8 days. In stage 3, methotrexate is commonly given concomitantly with other antitumour agents. Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods, and in stage 3 they respond to combined drug therapy with methotrexate given in doses of 0.625 mg to 2.5 mg/kg daily. Hodgkin's disease responds poorly to methotrexate and to most types of chemotherapy.

Mycosis Fungoides

Therapy with methotrexate appears to produce clinical remissions in one half of the cases treated. Recommended dosage is usually 2.5 to 10 mg daily by mouth for weeks or months and dosage should be adjusted according to the patient's response and haematological monitoring. Methotrexate has also been given intramuscularly in doses of 50 mg once weekly or 25 mg twice weekly.

Psoriasis Chemotherapy

Cases of severe uncontrolled psoriasis, unresponsive to conventional therapy, have responded to weekly single, oral, I.M. or I.V. doses of 10-25 mg per week, and adjusted according to the patient's response. An initial test dose one week prior to initiation of therapy is recommended to detect any idiosyncrasy. A suggested dose range is 5-10 mg.

An alternative dosage schedule consists of 2.5 to 5 mg of methotrexate administered orally at 12 hour intervals for 3 doses each week or at 8-hour intervals for 4 doses each week; weekly dosages should not exceed 30 mg.

A daily oral dosage schedule of 2 to 5 mg administered orally for 5 days followed by a rest period of at least 2 days may also be used. The daily dose should not exceed 6.25 mg.

The patient should be fully informed of the risks involved and the clinician should pay particular attention to the appearance of liver toxicity by carrying out liver function tests before starting methotrexate treatment, and repeating these at 2 to 4 month intervals during therapy. The aim of therapy should be to reduce the dose to the lowest possible level with the longest possible rest period. The use of methotrexate may permit the return to conventional topical therapy which should be encouraged.

4.3 Contraindications

Significantly impaired renal function.

Significantly impaired hepatic function

Pre-existing blood dyscrasias, such as significant marrow hypoplasia, leukopenia, thrombocytopenia or anaemia.

Methotrexate is contraindicated in pregnancy.

Because of the potential for serious adverse reactions from methotrexate in breast fed infants, breast feeding is contraindicated in women taking methotrexate.

Patients with a known allergic hypersensitivity to methotrexate should not receive methotrexate.

4.4 Special Warnings And Precautions For Use

WARNINGS

Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy.

Because of the possibility of fatal or severe toxic reactions, the patient should be fully informed by the physician of the risks involved and be under his constant supervision.

Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported. Symptoms typically include dyspnoea, cough (especially a dry non-productive cough) and fever for which patients should be monitored at each follow-up visit. Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.

Methotrexate should be withdrawn from patients with pulmonary symptoms and a thorough investigation should be made to exclude infection. If methotrexate induced lung disease is suspected treatment with corticosteroids should be initiated and treatment with methotrexate should not be restarted.

Deaths have been reported with the use of methotrexate in the treatment of psoriasis.

In the treatment of psoriasis, methotrexate should be restricted to severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established by biopsy and/or after dermatological consultation.

1. Full blood counts should be closely monitored before, during and after treatment. If a clinically significant drop in white-cell or platelet count develops, methotrexate should be withdrawn immediately. Patients should be advised to report all symptoms or signs suggestive of infection.

2. Methotrexate may be hepatotoxic, particularly at high dosage or with prolonged therapy. Liver atrophy, necrosis, cirrhosis, fatty changes, and periportal fibrosis have been reported. Since changes may occur without previous signs of gastrointestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy. If substantial hepatic function abnormalities develop, methotrexate dosing should be suspended for at least 2 weeks. Special caution is indicated in the presence of pre-existing liver damage or impaired hepatic function. Concomitant use of other drugs with hepatotoxic potential (including alcohol) should be avoided.

3. Methotrexate has been shown to be teratogenic; it has caused foetal death and/or congenital anomalies. Therefore it is not recommended in women of childbearing potential unless there is appropriate medical evidence that the benefits can be expected to outweigh the considered risks. Pregnant psoriatic patients should not receive methotrexate.

4. Renal function should be closely monitored before, during and after treatment. Caution should be exercised if significant renal impairment is disclosed. Reduce dose of methotrexate in patients with renal impairment. High doses may cause the precipitation of methotrexate or its metabolites in the renal tubules. A high fluid throughput and alkalinisation of the urine to pH 6.5 – 7.0, by oral or intravenous administration of sodium bicarbonate (5 x 625 mg tablets every three hours) or acetazolamide (500 mg orally four times a day) is recommended as a preventative measure. Methotrexate is excreted primarily by the kidneys. Its use in the presence of impaired renal function may result in accumulation of toxic amounts or even additional renal damage.

5. Diarrhoea and ulcerative stomatitis are frequent toxic effects and require interruption of therapy, otherwise haemorrhagic enteritis and death from intestinal perforation may occur.

6. Methotrexate affects gametogenesis during the period of its administration and may result in decreased fertility which is thought to be reversible on discontinuation of therapy. Conception should be avoided during the period of methotrexate administration and for at least 6 months thereafter. Patients and their partners should be advised to this effect.

7. Methotrexate has some immunosuppressive activity and immunological responses to concurrent vaccination may be decreased. The immunosuppressive effect of methotrexate should be taken into account when immune responses of patients are important or essential.

8. Pleural effusions and ascites should be drained prior to initiation of methotrexate therapy.

9. Deaths have been reported with the use of methotrexate. Serious adverse reactions including deaths have been reported with concomitant administration of methotrexate (usually in high doses) along with some non-steroidal anti-inflammatory drugs (NSAIDs).

10. Concomitant administration of folate antagonists such as trimethoprim/sulphamethoxazole has been reported to cause an acute megaloblastic pancytopenia in rare instances.

11. Systemic toxicity may occur following intrathecal administration. Blood counts should be monitored closely.

12. A chest X-ray is recommended prior to initiation of methotrexate therapy.

13. If acute methotrexate toxicity occurs, patients may require folinic acid.

PRECAUTIONS

Methotrexate has a high potential toxicity, usually dose related, and should be used only by physicians experienced in antimetabolite chemotherapy, in patients under their constant supervision. The physician should be familiar with the various characteristics of the drug and its established clinical usage.

Before beginning methotrexate therapy or reinstituting methotrexate after a rest period, assessment of renal function, liver function and blood elements should be made by history, physical examination and laboratory tests.

It should be noted that intrathecal doses are transported into the cardiovascular system and may give rise to systemic toxicity. Systemic toxicity of methotrexate may also be enhanced in patients with renal dysfunction, ascites, or other effusions due to prolongation of serum half-life.

Carcinogenesis, mutagenesis, and impairment of fertility: Animal carcinogenicity studies have demonstrated methotrexate to be free of carcinogenic potential. Although methotrexate has been reported to cause chromosomal damage to animal somatic cells and bone marrow cells in humans, these effects are transient and reversible. In patients treated with methotrexate, evidence is insufficient to permit conclusive evaluation of any increased risk of neoplasia.

Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans, during and for a short period after cessation of therapy. In addition, methotrexate causes, embryotoxicity, abortion and foetal defects in humans. Therefore the possible risks of effects on reproduction should be discussed with patients of childbearing potential (see 'Warnings').

Patients undergoing therapy should be subject to appropriate supervision so that signs or symptoms of possible toxic effects or adverse reactions may be detected and evaluated with minimal delay. Pretreatment and periodic haematological studies are essential to the use of methotrexate in chemotherapy because of its common effect of haematopoietic suppression. This may occur abruptly and on apparent safe dosage, and any profound drop in blood cell count indicates immediate stopping of the drug and appropriate therapy. In patients with malignant disease who have pre-existing bone marrow aplasia, leukopenia, thrombocytopenia or anaemia, methotrexate should be used with caution, if at all.

In general, the following laboratory tests are recommended as part of essential clinical evaluation and appropriate monitoring of patients chosen for or receiving methotrexate therapy: complete haemogram; haematocrit; urinalysis; renal function tests; liver function tests and chest X-ray.

The purpose is to determine any existing organ dysfunction or system impairment. The tests should be performed prior to therapy, at appropriate periods during therapy and after termination of therapy.

Liver biopsy may be considered after cumulative doses>1.5 g have been given, if hepatic impairment is suspected.

Methotrexate is bound in part to serum albumin after absorption, and toxicity may be increased because of displacement by certain drugs such as salicylates, sulphonamides, phenytoin, and some antibacterials such as tetracycline, chloramphenicol and para-aminobenzoic acid. These drugs, especially salicylates and sulphonamides, whether antibacterial, hypoglycaemic or diuretic, should not be given concurrently until the significance of these findings is established.

Vitamin preparations containing folic acid or its derivatives may alter response to methotrexate.

Methotrexate should be used with extreme caution in the presence of infection, peptic ulcer, ulcerative colitis, debility, and in extreme youth and old age. If profound leukopenia occurs during therapy, bacterial infection may occur or become a threat. Cessation of the drug and appropriate antibiotic therapy is usually indicated. In severe bone marrow depression, blood or platelet transfusions may be necessary.

Since it is reported that methotrexate may have an immunosuppressive action, this factor must be taken into consideration in evaluating the use of the drug where immune responses in a patient may be important or essential.

In all instances where the use of methotrexate is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risks of toxic effects or adverse reactions. Most such adverse reactions are reversible if detected early. When such effects or reactions do occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgement of the physician. Reinstitution of methotrexate therapy should be carried out with caution, with adequate consideration of further need for the drug and alertness as to the possible recurrence of toxicity.

Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Methotrexate is extensively protein bound and may be displaced by certain drugs such as salicylates, hypoglycaemics, diuretics, sulphonamides, diphenylhydantoins, tetracyclines, chloramphenicol and p-aminobenzoic acid, and the acidic anti-inflammatory agents, so causing a potential for increased toxicity when used concurrently.

Concomitant use of other drugs with nephrotoxic or hepatotoxic potential (including alcohol) should be avoided.

Vitamin preparations containing folic acid or its derivatives may decrease the effectiveness of methotrexate.

Caution should be used when NSAIDs and salicylates are administered concomitantly with methotrexate. These drugs have been reported to reduce the tubular secretion of methotrexate and thereby may enhance its toxicity. Concomitant use of NSAIDs and salicylates has been associated with fatal methotrexate toxicity.

However, patients using constant dosage regimens of NSAIDs have received concurrent doses of methotrexate without problems observed.

Renal tubular transport is also diminished by probenecid and penicillins; use of these with methotrexate should be carefully monitored.

Severe bone marrow depression has been reported following the concurrent use of methotrexate and co-trimoxazole or trimethoprim. Concurrent use should probably be avoided.

Methotrexate-induced stomatitis and other toxic effects may be increased by the use of nitrous oxide.

An increased risk of hepatitis has been reported following the use of methotrexate and the acitretin metabolite, etretinate. Consequently, the concomitant use of methotrexate and acitretin should be avoided.

4.6 Pregnancy And Lactation

Abortion, foetal death, and/or congenital anomalies have occurred in pregnant women receiving methotrexate, especially during the first trimester of pregnancy. Methotrexate is contraindicated in the management of psoriasis or rheumatoid arthritis in pregnant women. Women of childbearing potential should not receive methotrexate until pregnancy is excluded. For the management of psoriasis or rheumatoid arthritis, methotrexate therapy in women should be started immediately following a menstrual period and appropriate measures should be taken in men or women to avoid conception during and for at least 6 months following cessation of methotrexate therapy.

Both men and women receiving methotrexate should be informed of the potential risk of adverse effects on reproduction. Women of childbearing potential should be fully informed of the potential hazard to the foetus should they become pregnant during methotrexate therapy. In cancer chemotherapy, methotrexate should not be used in pregnant women or women of childbearing potential who might become pregnant unless the potential benefits to the mother outweigh the possible risks to the foetus.

Defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, and infertility have been reported in patients receiving methotrexate.

Methotrexate is distributed into breast milk. Because of the potential for serious adverse reactions to methotrexate in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

The most common adverse reactions include ulcerative stomatitis, leukopenia, nausea and abdominal distress. Although very rare, anaphylactic reactions to methotrexate have occurred. Others reported are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection. In general, the incidence and severity of side effects are considered to be dose-related. Adverse reactions as reported for the various systems are as follows:

Skin: Stevens-Johnson syndrome, epidermal necrolysis, erythematous rashes, pruritus, urticaria, photosensitivity, pigmentary changes, alopecia, ecchymosis, telangiectasia, acne, furunculosis. Lesions of psoriasis may be aggravated by concomitant exposure to ultraviolet radiation. Skin ulceration in psoriatic patients and rarely painful erosion of psoriatic plaques have been reported. The recall phenomenon has been reported in both radiation and solar damaged skin.

Blood: Bone marrow depression, leukopenia, thrombocytopenia, anaemia, hypogammaglobulinaemia, haemorrhage from various sites, septicaemia.

Alimentary System: Gingivitis, pharyngitis, stomatitis, anorexia, vomiting, diarrhoea, haematemesis, melaena, gastrointestinal ulceration and bleeding, enteritis, hepatic toxicity resulting in active liver atrophy, necrosis, fatty metamorphosis, periportal fibrosis, or hepatic cirrhosis. In rare cases the effect of methotrexate on the intestinal mucosa has led to malabsorption or toxic megacolon.

Hepatic: Hepatic toxicity resulting in significant elevations of liver enzymes, acute liver atrophy, necrosis, fatty metamorphosis, periportal fibrosis or cirrhosis or death may occur, usually following chronic administration.

Urogenital System: Renal failure, azotaemia, cystitis, haematuria, defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, infertility, abortion, foetal defects, severe nephropathy. Vaginitis, vaginal ulcers, cystitis, haematuria and nephropathy have also been reported.

Pulmonary System: Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported (see Section 4.4 Special warnings and special precautions for use). Acute pulmonary oedema has also been reported after oral and intrathecal use. Pulmonary fibrosis is rare. A syndrome consisting of pleuritic pain and pleural thickening has been reported following high doses.

Central Nervous System: Headaches, drowsiness, blurred vision, aphasia, hemiparesis and convulsions have occurred possibly related to haemorrhage or to complications from intraarterial catheterization. Convulsion, paresis, Guillain-Barre syndrome and increased cerebrospinal fluid pressure have followed intrathecal administration.

Other reactions related to, or attributed to the use of methotrexate such as pneumonitis, metabolic changes, precipitation of diabetes, osteoporotic effects, abnormal changes in tissue cells and even sudden death have been reported.

There have been reports of leukoencephalopathy following intravenous methotrexate in high doses, or low doses following cranial-spinal radiation.

Adverse reactions following intrathecal methotrexate are generally classified into three groups, acute, subacute, and chronic. The acute form is a chemical arachnoiditis manifested by headache, back or shoulder pain, nuchal rigidity, and fever. The subacute form may include paresis, usually transient, paraplegia, nerve palsies, and cerebellar dysfunction. The chronic form is a leukoencephalopathy manifested by irritability, confusion, ataxia, spasticity, occasionally convulsions, dementia, somnolence, coma, and rarely, death. There is evidence that the combined use of cranial radiation and intrathecal methotrexate increases the incidence of leukoencephalopathy.

Additional reactions related to or attributed to the use of methotrexate such as osteoporosis, abnormal (usually 'megaloblastic') red cell morphology, precipitation of diabetes, other metabolic changes, and sudden death have been reported.

4.9 Overdose

Calcium folinate (calcium leucovorin) is a potent agent for neutralizing the immediate toxic effects of methotrexate on the haematopoietic system. Where large doses or overdoses are given, calcium folinate may be administered by intravenous infusion in doses up to 75 mg within 12 hours, followed by 12 mg intramuscularly every 6 hours for 4 doses. Where average doses of methotrexate appear to have an adverse effect 6-12 mg of calcium folinate may be given intramuscularly every 6 hours for 4 doses. In general, where overdosage is suspected, the dose of calcium folinate should be equal to or higher than, the offending dose of methotrexate and should be administered as soon as possible; preferably within the first hour and certainly within 4 hours after which it may not be effective.

Other supporting therapy such as blood transfusion and renal dialysis may be required. Effective clearance of methotrexate has been reported with acute, intermittent haemodialysis using a high flux dialyser.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Methotrexate is an antimetabolite which acts principally by competitively inhibiting the enzyme, dihydrofolate reductase. In the process of DNA synthesis and cellular replication, folic acid must be reduced to tetrahydrofolic acid by this enzyme, and inhibition by methotrexate interferes with tissue cell reproduction. Actively proliferating tissues such as malignant cells are generally more sensitive to this effect of methotrexate. It also inhibits antibody synthesis.

Methotrexate also has immunosuppressive activity, in part possibly as a result of inhibition of lymphocyte multiplication. The mechanism(s) of action in the management of rheumatoid arthritis of the drug is not known, although suggested mechanisms have included immunosuppressive and/or anti-inflammatory effect.

5.2 Pharmacokinetic Properties

In doses of 0.1 mg (of methotrexate) per kg, methotrexate is completely absorbed from the gastrointestinal tract; larger oral doses may be incompletely absorbed. Peak serum concentrations are achieved within 0.5 - 2 hours following intravenous, intramuscular or intraarterial administration. Serum concentrations following oral administration of methotrexate may be slightly lower than those following intravenous injection.

Methotrexate is actively transported across cell membranes. The drug is widely distributed into body tissues with highest concentrations in the kidneys, gall bladder, spleen, liver and skin. Methotrexate is retained for several weeks in the kidneys and for months in the liver. Sustained serum concentrations and tissue accumulation may result from repeated daily doses. Methotrexate crosses the placental barrier and is distributed into breast milk. Approximately 50% of the drug in the blood is bound to serum proteins.

In one study, methotrexate had a serum half-life of 2-4 hours following intramuscular administration. Following oral doses of 0.06 mg/kg or more, the drug had a serum half-life of 2-4 hours, but the serum half-life was reported to be increased to 8-10 hours when oral doses of 0.037 mg/kg were given.

Methotrexate does not appear to be appreciably metabolised. The drug is excreted primarily by the kidneys via glomerular filtration and active transport. Small amounts are excreted in the faeces, probably via the bile. Methotrexate has a biphasic excretion pattern. If methotrexate excretion is impaired accumulation will occur more rapidly in patients with impaired renal function. In addition, simultaneous administration of other weak organic acids such as salicylates may suppress methotrexate clearance.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide and Water for Injections

6.2 Incompatibilities

Immediate precipitation or turbidity results when combined with certain concentrations of droperidol, heparin sodium, metoclopramide hydrochloride, ranitidine hydrochloride in syringe.

6.3 Shelf Life

As packaged for sale – 30 months

After dilution – Chemical and physical in-use stability has been demonstrated in dextrose 5% and sodium chloride 0.9% infusion solutions for 30 days at 4°C in PVC containers when protected from light.

From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

As packaged for sale – Do not store above 25°C. Do not freeze. Keep container in the outer carton.

After dilution – see 6.3.

6.5 Nature And Contents Of Container

1 g/10 ml - Conventional, or Onco-Tain® Type I glass vial with rubber stopper, aluminium seal and plastic 'flip-off' top, or Onco-Vial ®Type I glass vials with rubber stopper. Packs containing 1 vial.

5 g/50 ml - Conventional, or Onco-Tain® Type I glass vial with rubber stopper, aluminium seal and plastic 'flip-off' top, or Onco-Vial ®Type I glass vials with rubber stopper. Packs containing 1 vial.

Not all presentations and pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Single use only. Discard any unused contents.

Onco-Vials ® should be used with an appropriate Faulding administration device.

7. Marketing Authorisation Holder

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire, CV31 3RW

8. Marketing Authorisation Number(S)

PL 04515/0038

9. Date Of First Authorisation/Renewal Of The Authorisation

7th June 1994

10. Date Of Revision Of The Text

January 2008


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Cyclessa


Generic Name: ethinyl estradiol and desogestrel (EH thih nill ess tra DYE ole and des oh JESS trel)
Brand Names: Apri, Cesia, Cyclessa, Desogen, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet

What is Cyclessa (ethinyl estradiol and desogestrel)?

Ethinyl estradiol and desogestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and desogestrel are used as contraception to prevent pregnancy.

Ethinyl estradiol and desogestrel may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cyclessa (ethinyl estradiol and desogestrel)? Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Cyclessa (ethinyl estradiol and desogestrel)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke or blood clot;

circulation problems (especially if caused by diabetes);

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease or liver cancer;

severe high blood pressure;

severe migraine headaches;

a heart valve disorder; or

a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dosage adjustment or special tests to safely take birth control pills.

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

high cholesterol or if you are overweight;

a history of depression;

gallbladder disease;

diabetes;

seizures or epilepsy;

a history of irregular menstrual cycles; or

a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. How should I take Cyclessa (ethinyl estradiol and desogestrel)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat. What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week 3, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Cyclessa (ethinyl estradiol and desogestrel)? Do not smoke while using this medication, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Cyclessa (ethinyl estradiol and desogestrel) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

swelling in your hands, ankles, or feet;

a breast lump; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cyclessa (ethinyl estradiol and desogestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

an antibiotic;

phenylbutazone (Azolid, Butazolidin);

St. John's wort;

seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.

This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Cyclessa resources Cyclessa Side Effects (in more detail)Cyclessa Use in Pregnancy & BreastfeedingDrug ImagesCyclessa Drug InteractionsCyclessa Support Group5 Reviews for Cyclessa - Add your own review/rating Cyclessa Advanced Consumer (Micromedex) - Includes Dosage Information Cyclessa Prescribing Information (FDA) Apri Prescribing Information (FDA) Caziant Prescribing Information (FDA) Cesia Prescribing Information (FDA) Desogen Consumer Overview Desogen MedFacts Consumer Leaflet (Wolters Kluwer) Desogen Prescribing Information (FDA) Emoquette Prescribing Information (FDA) Kariva Prescribing Information (FDA) Mircette Consumer Overview Mircette Prescribing Information (FDA) Ortho-Cept Prescribing Information (FDA) Reclipsen Prescribing Information (FDA) Solia Prescribing Information (FDA) Velivet Prescribing Information (FDA) Compare Cyclessa with other medications Abnormal Uterine BleedingBirth ControlEndometriosisGonadotropin InhibitionPolycystic Ovary Syndrome Where can I get more information? Your pharmacist can provide more information about ethinyl estradiol and desogestrel.

See also: Cyclessa side effects (in more detail)


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Surpass Cream



Dosage Form: FOR ANIMAL USE ONLY
Surpass®
(1% diclofenac sodium)
Topical Anti-Inflammatory Cream
For Use in Horses

NADA 141-186, Approved by FDA

Veterinary Package Insert

Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Surpass® topical cream contains 1% diclofenac sodium. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) of the phenylacetic acid class. The chemical name for diclofenac is sodium [o- (2,6-dichloroanilino)phenyl]acetate. The empirical formula is C14H10Cl2NNaO2 and the molecular weight is 318.13. Surpass topical cream contains 1% diclofenac sodium in a base composed of Phospholipon 90H, propylene glycol, alcohol (5.94%), vitamin E acetate, benzethonium chloride and purified water in the Wisdom® liposomal formulation.

Indications

Surpass topical cream is indicated for the control of pain and inflammation associated with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal interphalangeal (hock, knee, fetlock and pastern) joints in horses.

Dosage and Administration

Always provide the Client Information Sheet with the prescription.

Dosage: Apply a five-inch (5") ribbon of Surpass topical cream twice daily over the affected joint for up to ten days.

Administration: Wear rubber gloves to prevent absorption into the hands. Rub the cream thoroughly into the hair covering the joint until it disappears.

Contraindications

Surpass topical cream is contraindicated in animals with known hypersensitivity to diclofenac.

Warnings

Not for horses intended for human consumption.

User Safety: Keep out of reach of children. Not for human use. Consult a physician in case of accidental ingestion by humans.

Wear gloves to prevent absorption into the hands. Direct contact with the skin should be avoided. If contact occurs, the skin should be washed immediately with soap and water.

Animal Safety:  For topical use in horses only. Owners should be advised to observe for signs of potential drug toxicity (See Information for Owner or Person Treating Animal and Adverse Reactions).

Precautions

Exceeding the recommended dosage or treating multiple joints may increase plasma concentrations of diclofenac (See Animal Safety). The systemic effects of excess diclofenac doses that exceed the recommended label amount and duration have not been evaluated.

Horses should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data before and periodically during administration of any NSAID. Owners should be advised to observe for signs of potential drug toxicity (See Information for Owner or Person Treating Animal).

Treatment with Surpass Cream should be terminated if signs such as inappetence, colic, fecal abnormalities, anemia or depression are observed.

As a class, NSAIDs may be associated with gastrointestinal and renal toxicity. When NSAIDs inhibit prostaglandins that cause inflammation, they may also inhibit prostaglandins that maintain normal homeostatic function. These anti-prostaglandin effects may result in clinically significant disease in patients with underlying or preexisting disease more often than in healthy patients. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with renal, cardiovascular and/or hepatic dysfunction.

Studies to determine the effect of Surpass topical cream when administered concomitantly with other drugs have not been conducted. Since many NSAIDs possess the potential to induce gastric ulceration, concomitant use of Surpass Cream with any other anti-inflammatory drugs, such as other NSAIDs and corticosteroids, should be avoided. Drug compatibility should be monitored closely in patients receiving adjunctive therapy.

The safety of Surpass Cream has not been investigated in breeding, pregnant or lactating horses, or in horses under one year of age.

Adverse Reactions

During the field study, one diclofenac-treated horse developed colic on day four of the study and responded to symptomatic treatment. One placebo-treated horse exhibited mildly jaundiced mucous membranes on day five. Adverse reactions during the safety study included a gastric ulcer in one horse that received 5.6X the recommended dosage, diarrhea and uterine discharge in one horse that received 2.8X the recommended dosage, and weight loss in four of the six horses in the 5.6X dosage group.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance, call 1-866-638-2226.

Information for Owner or Person Treating Animal

Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with NSAID intolerance. Adverse reactions may include: weight loss, colic, diarrhea, or icterus. Serious adverse reactions associated with this drug class can occur without warning and, in rare situations, result in death. Owners should be advised to discontinue NSAID therapy and contact their veterinarian immediately if signs of intolerance are observed. The majority of patients with drug-related adverse reactions recover when the signs are recognized, drug administration is stopped, and veterinary care is initiated.

Clinical Pharmacology

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic properties. The mechanism of action of diclofenac, like other NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity.

Effectiveness

In a controlled field study, 82 horses with osteoarthritis were treated with Surpass topical cream (42 horses) or placebo (40 horses). Lameness examinations were performed in horses with osteoarthritis associated with the tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal interphalangeal joints. Investigators were masked to treatment. Investigators and owners were instructed to apply the test article over the affected joint twice daily (BID) for five days. Actual doses received by individual horses were calculated using tube weight measurements. The mean dose applied during the study was 73 mg per application. Average lameness scores showed statistically significant improvement following treatment with Surpass topical cream.

One diclofenac-treated horse developed colic and responded to symptomatic treatment on day four of the study. Day five bloodwork for the horse that colicked showed decreases in RBC, Hb and HCT, with an increase in PMNs, compared to pretreatment values. One placebo-treated horse exhibited mildly jaundiced mucous membranes on day five. No other adverse reactions were noted during the study.

Animal Safety

A controlled safety study was conducted with Surpass topical cream. Four groups of six healthy adult horses received 0, 0.6, 1.7 or 2.8X the recommended daily dose for twenty-eight days. The daily dose was divided into two applications on day one of the study. For the remainder of the study, the entire daily dose was given at one time on 0, 1, 3 or 5 joints (tarsal, carpal, metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal joints), depending on the dosage group. The control group of six horses was sham-dosed by rubbing the joints daily for twenty-eight days. An additional study group evaluated six horses that received 5.6X the recommended daily dose of Surpass topical cream distributed over five joints on a single day. This dose group was observed for fourteen days without additional treatment.

Clinical examinations, hematology, serum chemistry, synovial fluid analyses, gross necropsy and histopathology were performed. At necropsy, one horse in the 5.6X group had a glandular gastric ulcer. A horse in the 2.8X group had diarrhea and uterine discharge throughout the study. Four of the six horses in the 5.6X group lost weight during the study.

Dose-dependent increases in diclofenac plasma concentrations were detected in horses in the 1.7X and 2.8X treatment groups.

Storage Information

Store at up to 25°C (77°F). Protect from freezing.

How Supplied

Surpass topical cream is white to pinkish-white and is packaged in 124-gram trilaminate tubes.

Surpass and Wisdom are registered trademarks of Boehringer Ingelheim Vetmedica, Inc.

Manufactured for:
Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.
Manufactured under U.S. Patent Nos. 4,937,078 and 6,936,273.
© 2009 Boehringer Ingelheim Vetmedica, Inc.
All Rights Reserved.
449801L-00-0901
Revised 01/2009
Code 449811

Client Information Sheet

This summary contains important information about Surpass® topical cream. You should read this information before treating your horse with Surpass Cream. This sheet of information is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you have any questions about this information or to learn more about Surpass topical cream.

1. What is Surpass topical cream?

Surpass topical cream contains 1% diclofenac sodium. Diclofenac is a prescription non-narcotic, non-steroidal anti-inflammatory drug (NSAID) that controls pain. Diclofenac is used for the control of pain and inflammation associated with osteoarthritis (OA) in hock, knee, fetlock or pastern joints in horses.

2. What kind of results can I expect when my horse is being treated with Surpass Cream?

Osteoarthritis is a painful condition caused by the progressive deterioration of the cartilage, accompanied by changes in the bone and soft tissues of the joint. This disease is characterized by pain and loss of function of the affected joint.

While Surpass topical cream is not a cure for osteoarthritis, it does control the pain and inflammation associated with OA and increases the horse’s mobility. The response to Surpass Cream will vary from horse to horse. In most horses, maximum improvement is seen in less than one week.

3. Which horses should not receive treatment with Surpass topical cream?

Surpass Cream is for topical use in horses only. Surpass Cream should not be used in horses exhibiting allergic reactions to diclofenac. Surpass topical cream is not for horses intended for human consumption. The safety of Surpass Cream has not been determined in horses less than one year of age, in horses used for breeding, pregnant mares, or mares nursing foals.

4. How do I apply Surpass topical cream to my horse?

Wear gloves to prevent absorption into the hands. Direct contact with the skin should be avoided. If contact occurs, the skin should be washed immediately with soap and water. Apply a five-inch (5") ribbon of Surpass Cream twice daily over the affected joint for up to ten days. Rub it thoroughly into the hair covering the joint until it disappears.

5. What should I tell my veterinarian?

Tell your veterinarian if your horse has experienced allergic reactions to diclofenac or other medications. Tell your veterinarian if your horse is pregnant or nursing a foal, or if you intend to breed the horse. Tell your veterinarian if your horse has ever been diagnosed with an ulcer.

6. What possible side effects may occur in my horse’s therapy?

Horses should undergo a thorough history and physical examination by a veterinarian before the initiation of any Surpass therapy. Using more than the recommended amount of Surpass topical cream (for example, by treating multiple joints) has not been tested and is not recommended. Excessive doses to the skin have been shown to enter the bloodstream and this may increase the risk of side effects. Adverse reactions associated with NSAIDs may include: weight loss, colic, diarrhea, or yellowing of the gums, skin, or whites of the eyes (jaundice). Serious adverse reactions associated with this drug class can occur without warning and, in rare situations, result in death. Discontinue the use of Surpass Cream and contact your veterinarian immediately if these signs are observed. The majority of patients with drug-related adverse reactions recover when the signs are recognized, drug administration is stopped, and veterinary care, if appropriate, is initiated.

7. What precautions should I take before administering Surpass topical cream?

Wear gloves to prevent absorption into the hands. Direct contact with the skin should be avoided. If contact occurs, the skin should be washed immediately with soap and water.

Surpass topical cream should only be applied to horses. Keep Surpass Cream and all medications out of the reach of children. Surpass Cream is not for human use. Contact a physician in case of accidental ingestion by people.

8. Can Surpass topical cream be given with other medications?

Surpass Cream should not be given with any other anti-inflammatory drugs, such as other NSAIDs (for example, aspirin, phenylbutazone, flunixin) and corticosteroids (for example, cortisone, prednisone, dexamethasone, triamcinolone). Tell your veterinarian about all medicines that you are planning to administer in addition to Surpass Cream. These should include other medications that you can obtain without a prescription.

9. How should I store Surpass topical cream?

Store at up to 25°C (77°F). Protect from freezing. Keep Surpass Cream and all medications out of reach of children.

10. What else should I know about Surpass topical cream?

This document provides a summary of information about Surpass topical cream. If you have questions or concerns about Surpass Cream or osteoarthritis pain, talk to your veterinarian.

As with all prescription medications, Surpass Cream should only be administered to the patient for whom it was prescribed, and should only be used as prescribed.

To report a suspected adverse reaction, call 1-866-638-2226.

Surpass is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.
Manufactured for:
Boehringer Ingelheim Vetmedica, Inc.
St. Joseph, MO 64506 U.S.A.
Manufactured under U.S. Patent Nos. 4,937,078 and 6,936,273.

©2009 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

449804L-00-0901
 

Tube Label 124 g Display Carton 124 g
SURPASS 
diclofenac sodium  cream Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0010-4498 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 0.01 g  in 1 g Inactive Ingredients Ingredient Name Strength WATER 0.77 g  in 1 g Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0010-4498-01 1 TUBE In 1 CARTON contains a TUBE 1 124 g In 1 TUBE This package is contained within the CARTON (0010-4498-01)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141186 05/20/2004
Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091) Registrant - Boehringer Ingelheim Vetmedica, Inc. (007134091) Revised: 10/2010Boehringer Ingelheim Vetmedica, Inc.
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Equioxx



Dosage Form: FOR ANIMAL USE ONLY
Equioxx®
Oral Paste for Horses (firocoxib)

Non-steroidal anti-inflammatory drug for oral use in horses only.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Equioxx® (firocoxib) belongs to the coxib class of non-narcotic, non-steroidal anti-inflammatory drugs. Firocoxib is a white crystalline compound described chemically as 3-(cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)-5,5-dimethylfuranone. The empirical formula is C17H20O5S, and the molecular weight is 336.4. The structural formula is shown below:

Indications

Equioxx Oral Paste is administered for up to 14 days for the control of pain and inflammation associated with osteoarthritis in horses.

Dosage and Administration

Always provide the Client Information Sheet with the prescription. The recommended dosage of Equioxx (firocoxib) for oral administration in horses is 0.045 mg/lb (0.1 mg/kg) of body weight once daily for up to14 days. In target animal safety studies, toxicity was seen at the recommended dose when the duration of treatment exceeded 30 days.

Each marking on the syringe will treat 250 pounds of body weight, and each notch corresponds to approximately a 50 lb weight increment. To deliver the correct dose, round the horse's body weight up to the nearest 50 pound increment (if the body weight is an exact 50 pound increment, do not round up). Unlock the knurled ring on the syringe plunger by rotating it ? turn. Slide the knurled ring along the plunger shaft so that the side nearest the barrel is at the appropriate 50 lb weight notch. Rotate the plunger ring ? turn to lock it in place and ensure it is locked.

Equioxx may be given with or without food.

Contraindications

Horses with hypersensitivity to firocoxib or other NSAIDs should not receive Equioxx Oral Paste.

Warnings

For oral use in horses only. Do not use in horses intended for human consumption.

Human Warnings

Not for use in humans. Keep this and all medications out of the reach of children. Consult a physician in case of accidental ingestion by humans.

Animal Safety

Clients should be advised to observe for signs of potential drug toxicity and be given a Client Information Sheet with each prescription.

For technical assistance or to report suspected adverse events, call 1-877-217-3543.

Precautions

Horses should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data before and periodically during administration of any NSAID. Clients should be advised to observe for signs of potential drug toxicity and be given a Client Information Sheet with each prescription. See Information for Owner or Person Treating Horse section of this package insert.

Treatment with Equioxx should be terminated if signs such as inappetance, colic, abnormal feces, or lethargy are observed.

As a class, cyclooxygenase inhibitory NSAIDs may be associated with renal and gastrointestinal toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached or avoided. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since many NSAIDs possess the potential to produce gastrointestinal ulcerations, concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored. The concomitant use of protein bound drugs with Equioxx Oral Paste has not been studied in horses. The influence of concomitant drugs that may inhibit the metabolism of Equioxx Oral Paste has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

The safe use of Equioxx Oral Paste in horses less than one year in age, horses used for breeding, or in pregnant or lactating mares has not been evaluated.

Consider appropriate washout times when switching from one NSAID to another NSAID or corticosteroid.

Adverse Reactions

In controlled field studies, 127 horses (ages 3 to 37 years) were evaluated for safety when given Equioxx Oral Paste at a dose of 0.045 mg/lb (0.1 mg/kg) orally once daily for up to 14 days. The following adverse reactions were observed. Horses may have experienced more than one of the observed adverse reactions during the study.

Adverse Reactions Seen in U.S. Field Studies Adverse
Reactions Equioxx
n=127 Active Control
n=125 Equioxx (firocoxib) Oral Paste was safely used concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics, during the field studies. Abdominal pain 0 1 Diarrhea 2 0   Excitation 1 0   Lethargy 0 1   Loose stool 1 0   Polydipsia 0 1   Urticaria 0 1   Information for Owner or Person Treating Horse

You should give a Client Information Sheet to the person treating the horse and advise them of the potential for adverse reactions and the clinical signs associated with NSAID intolerance. Adverse reactions may include erosions and ulcers of the gums, tongue, lips and face, weight loss, colic, diarrhea, or icterus. Serious adverse reactions associated with this drug class can occur without warning and, in rare situations, result in death. Clients should be advised to discontinue NSAID therapy and contact their veterinarian immediately if any of these signs of intolerance are observed. The majority of patients with drug-related adverse reactions recover when the signs are recognized, drug administration is stopped, and veterinary care is initiated.

Clinical Pharmacokinetics / Pharmacodynamics Pharmacokinetics

When administered as a 0.045 mg/lb (0.1 mg/kg) dose in oral paste to adult horses with normal access to roughage, feed, and water, the absolute bioavailability of firocoxib from Equioxx paste is approximately 79%. Following oral administration, drug peak concentration (Cmax) of 0.08 mcg/mL can be reached at 4 hours (Tmax) post-dosing. However, in some animals, up to 12 hours may be needed before significant plasma concentrations are observed. Little drug amount distributes into blood cells. The major metabolism mechanism of firocoxib in the horse is decyclopropylmethylation followed by glucuronidation of that metabolite. Based upon radiolabel studies, the majority of label is eliminated in the urine as the decyclopropylmethylated metabolite. Despite a high rate of plasma protein binding (98%), firocoxib exhibits a large volume of distribution (mean Vd(ss) = 1652 mL/kg). The terminal elimination half-life (T?) in plasma averages 30-40 hours after IV or oral paste dosing. Therefore, drug accumulation occurs with repeated dose administrations and steady state concentrations are achieved beyond 6-8 daily oral doses in the horse. Dose linearity exists from 1?-2? of 0.1 mg/kg/day.

Mode of action

Equioxx (firocoxib) is a cyclooxygenase-inhibiting (coxib) class, non-narcotic, non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic activity in animal models.

Effectiveness

Two hundred fifty-three client-owned horses of various breeds, ranging in age from 2 to 37 years and weighing from 595 to 1638 lbs, were randomly administered Equioxx or an active control drug in multi-center field studies. Two hundred forty horses were evaluated for effectiveness and 252 horses were evaluated for safety. Horses were assessed for lameness, pain on manipulation, range of motion, joint swelling, and overall clinical improvement in a non-inferiority evaluation of Equioxx compared to an active control. At study's end, 84.4% of horses treated with Equioxx were judged improved on veterinarians' clinical assessment, and 73.8% were also rated improved by owners. Horses treated with Equioxx showed improvement in veterinarian-assessed lameness, pain on manipulation, range of motion, and joint swelling that was comparable to the active control.

Acceptability

Equioxx Oral Paste was rated both convenient to administer (95.3%) and acceptable to the horse (97.6%) by owners in the multi-center field study.

Animal Safety

In a target animal safety study, firocoxib was administered orally to healthy adult horses (two male castrates and four females per group) at 0, 0.1, 0.3 and 0.5 mg firocoxib/kg body weight (1, 3 and 5? the recommended dose) for 30 days. Administration of firocoxib at 0.3 and 0.5 mg/kg body weight was associated with an increased incidence of oral ulcers as compared to the control group but, no oral ulcers were noted with 0.1 mg/kg. There were no other drug-related adverse findings in this study.

In another target animal safety study, firocoxib was administered orally to healthy adult horses (four males or male castrates and four females per group) at 0, 0.1, 0.3 and 0.5 mg firocoxib/kg body weight (1, 3 and 5? the recommended dose) for 42 days. Administration of firocoxib at 0.1, 0.3 and 0.5 mg/kg body weight was associated with delayed healing of pre-existing oral (lip, tongue, gingival) ulcers. In addition, the incidence of oral ulcers was higher in all treated groups as compared to the control group.

Clinical chemistry and coagulation abnormalities were seen in several horses in the 0.5 mg/kg (5?) group. One 5? male horse developed a mildly elevated BUN and creatinine over the course of the study, prolonged buccal mucosal bleeding time (BMBT), and a dilated pelvis of the right kidney. Another 5? male had a similar mild increase in creatinine during the study but did not have any gross abnormal findings. One female in the 5? group had a prolonged BMBT, bilateral tubulointerstitial nephropathy and bilateral papillary necrosis.

Tubulointerstitial nephropathy occurred in one 3? female, two 3? male horses, and the 5? female horse discussed above with the prolonged BMBT. Papillary necrosis was present in one 1? male horse and the 5? female horse discussed above. Despite the gross and microscopic renal lesions, all of the horses were clinically healthy and had normal hematology, clinical chemistry and urinalysis values.

In another target animal safety study, firocoxib was administered orally to healthy adult horses (three females, two male castrates and one male per group) at 0, 0.25 mg/kg, 0.75 mg/kg and 1.25 mg/kg (2.5, 7.5 and 12.5? the recommended dose of 0.1 mg/kg) for 92 days. An additional group of three females, two male castrates and one male per group, was dosed at 1.25 mg/kg for 92 days but was monitored until Days 147-149. There were treatment-related adverse events in all treated groups. These consisted of ulcers of the lips, gingiva and tongue and erosions of the skin of the mandible and head. Gross and microscopic lesions of the kidneys consistent with tubulointerstitial nephropathy were seen in all treated groups. Papillary necrosis was seen in the 2.5? and 12.5? groups. In addition, several 12.5? horses had elevated liver enzymes (GGT, SDH, AST and ALT). One 2.5? horse had increased urine GGT and urine protein levels which was due to renal hemorrhage and nephropathy. Gastric ulcers of the margo plicatus and glandular area were more prevalent in the 2.5? and 7.5? groups, but not seen in the 12.5? group. The group of horses that were monitored until Days 147-149 showed partial to full recovery from oral and skin ulcers, but no recovery from tubulointerstitial nephropathy.

Storage Information

Store below 86°F (30°C). Brief excursions up to 104°F (40°C) are permitted.

How Supplied

Equioxx is available in packs of 20 individually-boxed syringes and packs of 72 individually wrapped syringes. Each syringe contains 6.93 grams of Equioxx paste, sufficient to treat a 1250 lb. horse.

Marketed by:
Merial LLC, Duluth, GA 30096-4640

Made in Brazil

For technical assistance or to report suspected adverse reactions, call 1-877-217-3543.

NADA 141-253, Approved by FDA

©2009 Merial. All Rights Reserved.

U.S. Pat. No.: 5981576, 6020343

®Equioxx is a registered trademark of Merial.

Rev. 10-09

PATIENT PACKAGE INSERT

Equioxx®
Oral Paste for Horses (firocoxib)

Non-steroidal anti-inflammatory drug

Information for Horse Owners

Equioxx® Oral Paste is administered for up to 14 days for the control of pain and inflammation associated with osteoarthritis in horses.

This summary contains important information about Equioxx. You should read this information before you start giving your horse Equioxx paste and review it each time your prescription is refilled. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or you want to know more about Equioxx.

   

What is Equioxx?

Equioxx is a veterinary prescription non-steroidal anti-inflammatory drug
(NSAID) of the coxib class used to control pain and inflammation associated with osteoarthritis in horses. Osteoarthritis (OA) is a painful condition caused by progressive "wear and tear" of cartilage and other parts of the joints that may result in the following changes or signs in your horse:

Limping or lameness. Decreased activity or exercise (reluctance to stand, walk, trot or run, or difficulty in performing these activities). Stiffness or decreased movement of joints.    

How to give Equioxx to your horse.

Equioxx should be given according to your veterinarian's instructions. Do not change the way you give Equioxx to your horse without first speaking with your veterinarian. Do not exceed 14 days of treatment.

The recommended dosage of Equioxx (firocoxib) for oral administration in horses is 0.045 mg/lb (0.1 mg/kg) of body weight once daily for up to 14 days. Each marking on the syringe will treat 250 pounds of body weight, and each notch corresponds to approximately a 50 lb weight increment. To deliver the correct dose, round the horse's body weight up to the nearest 50 pound increment (if the body weight is an exact 50 pound increment, do not round up). Unlock the knurled ring on the syringe plunger by rotating it ? turn. Slide the knurled ring along the plunger shaft so that the side nearest the barrel is at the appropriate 50 lb weight notch. Rotate the plunger ring ? turn to lock it in place and ensure it is locked.

Equioxx may be given with or without food.

   

What kind of results can I expect when my horse is on Equioxx for OA?

While Equioxx is not a cure for osteoarthritis, it can control the pain and
inflammation associated with OA and can improve your horse's mobility.

Response varies from horse to horse, but improvement can be quite dramatic. Improvement can be seen in just a few hours in most horses.    

Which horses should not receive Equioxx?

Your horse should not be given Equioxx if he/she:

Has an allergic reaction to firocoxib, the active ingredient in Equioxx. Has previously had an allergic reaction (such as hives, facial or lower limb swelling, or red or itchy skin) to aspirin or other NSAIDs. Is presently taking aspirin, phenylbutazone, flunixin meglumine, diclofenac, ketoprofen, or other NSAIDs or corticosteroids. The safety of Equioxx has not been determined in horses less than one year of age or in breeding horses, pregnant or lactating mares.    

Equioxx paste should only be given orally to horses.

Equioxx is not for use in horses intended for human food consumption. People should not take Equioxx. Keep Equioxx and all medications out of the reach of children. Consult a physician in case of accidental ingestion by humans.    

What to tell/ask your veterinarian before giving Equioxx.

Talk to your veterinarian about:

The signs of OA you have observed in your horse, such as limping or stiffness. If any tests, such as X-rays, will be done before Equioxx is prescribed. How often your horse may need to be examined by your veterinarian. The risks and benefits of using Equioxx.

Tell your veterinarian if your horse has ever had the following medical problems:

Any side effects from taking Equioxx or other NSAIDs, such as aspirin or phenylbutazone. Any kidney disease. Any liver disease. Any gastrointestinal ulcers.

Tell your veterinarian about:

Other medical problems or allergies that your horse has now, or has had in the past. All medicines that you are giving or plan to give to your horse, including those you can get without a prescription and any dietary supplements.

Tell your veterinarian if you plan to breed your horse, or if your mare is pregnant or nursing a foal.

   

What are the possible side effects that may occur in my horse during Equioxx
therapy?

Equioxx, like other NSAIDS, may cause some side effects. Serious side effects associated with NSAID therapy in horses can occur with or without warning. The most common side effects associated with Equioxx therapy involve the tongue, lips and skin of the mouth and face (erosions and ulcers of the mucosa and skin) and the kidney. Gastrointestinal, kidney and liver problems have also been reported with other NSAIDs. Look for the following side effects that may indicate your horse is having a problem with Equioxx or may have another medical problem:

Sores or ulcers on the tongue and inside of mouth. Sores, scabs, redness, or rubbing of the facial skin, particularly around the mouth. Change in eating or drinking habits (frequency or amount consumed). Change in urination habits (frequency or color). Yellowing of gums, skin, or whites of the eyes (jaundice). Unexpected weight loss. Change in behavior (such as increased or decreased activity level).

It is important to stop therapy and contact your veterinarian if you think your horse has a medical problem or side effect while taking Equioxx paste. If you have additional questions about possible side effects, talk with your veterinarian or call 1-877-217-3543.

   

Can Equioxx be given with other medications?

Equioxx should not be given with other NSAIDs (for example, aspirin, phenylbutazone, diclofenac, ketoprofen or flunixin) or systemic corticosteroids (for example, prednisone, cortisone, dexamethasone, or triamcinolone).

Tell your veterinarian about all medications that you have given your horse in the past, and any medications you are planning to give with Equioxx paste. This should include other medicines that you can get without a prescription or any dietary supplements. Your veterinarian may want to check that all of your horse's medicines can be given together.

   

What do I do in case my horse receives more than the prescribed amount of Equioxx?

Consult your veterinarian if your horse receives more than the prescribed
amount of Equioxx.    

What else should I know about Equioxx?

This sheet provides a summary of information about Equioxx paste and general information about NSAIDs. If you have any questions or concerns about Equioxx or osteoarthritis pain, talk with your veterinarian. As with all prescribed medicines, Equioxx paste should only be given to the horse for which it is prescribed. It should be given to your horse only for the condition for which it is prescribed, at the labeled dose and duration. It is important to periodically discuss your horse's response to Equioxx paste. Your veterinarian will determine if your horse is responding as expected and if your horse should continue receiving Equioxx paste. PRINCIPAL DISPLAY PANEL - 6.93 g Syringe Carton

[NADA 141-253,
Approved by FDA]

Equioxx®
(firocoxib)

Non-steroidal
anti-inflammatory
for the control of pain
and inflammation associated
with osteoarthritis in horses.

Net Wt. 6.93 g

Oral Paste for Horses

Caution: Federal law restricts
this drug to use by or on the
order of a licensed veterinarian.


Equioxx 
firocoxib  paste Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 50604-6597 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength firocoxib (firocoxib) firocoxib 8.2 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 50604-6597-1 1 SYRINGE In 1 CARTON contains a SYRINGE, PLASTIC 1 6.93 g In 1 SYRINGE, PLASTIC This package is contained within the CARTON (50604-6597-1) 2 50604-6597-2 72 SYRINGE In 1 CARTON contains a SYRINGE, PLASTIC 2 6.93 g In 1 SYRINGE, PLASTIC This package is contained within the CARTON (50604-6597-2)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141253 12/30/2005
Labeler - Merial Limited (034393582) Revised: 06/2010Merial Limited
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Symlin Vial


Pronunciation: PRAM-lin-tide
Generic Name: Pramlintide
Brand Name: Symlin

Symlin Vial is used along with insulin. It may increase the risk of severe low blood sugar caused by insulin. The risk may be higher in patients with type 1 diabetes. If this occurs, it is seen within 3 hours after an injection of Symlin Vial. Use caution if you will be driving or performing other possibly unsafe tasks. Be sure you understand how to use Symlin Vial and how to recognize low blood sugar. Discuss any questions or concerns with your health care provider.


Symlin Vial is used for:

Treating diabetes in certain patients who also use insulin.

Symlin Vial is an amylin analog. It works by slowing down food digestion. This prevents blood sugar from rising as quickly after you eat. It may also help you feel full faster.

Do NOT use Symlin Vial if: you are allergic to any ingredient in Symlin Vial, including metacresol you have a condition that causes your stomach to empty very slowly (gastroparesis) you cannot tell when your blood sugar is low you take an alpha glucosidase inhibitor (eg, acarbose) or an anticholinergic (eg, scopolamine, hyoscyamine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Symlin Vial:

Some medical conditions may interact with Symlin Vial. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have vision or coordination problems, or a history of stomach or bowel problems if you have had severe low blood sugar within the past 6 months, have diabetic nerve disease (eg, peripheral neuropathy), or have high hemoglobin A1c if you have trouble using your insulin therapy or monitoring your blood sugar levels if you are on dialysis if you take medicine that helps food move through your stomach more quickly

Some MEDICINES MAY INTERACT with Symlin Vial. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta blockers (eg, propranolol), clonidine, guanethidine, or reserpine because they may hide the symptoms of low blood sugar Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fibrates (eg, clofibrate), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), pentoxifylline, propoxyphene, salicylates (eg, aspirin), sulfonamide antibiotics (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased Alpha glucosidase inhibitors (eg, acarbose) or anticholinergics (eg, scopolamine, hyoscyamine) because they may increase the risk of Symlin Vial's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Symlin Vial may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Symlin Vial:

Use Symlin Vial as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Symlin Vial comes with an extra patient information sheet called a Medication Guide. It also comes with a "Patient Instructions for Use" sheet. Read these information sheets carefully before you use Symlin Vial. Read them again each time you get Symlin Vial refilled. Use Symlin Vial immediately before major meals, as directed by your health care provider. A health care provider will teach you how to use Symlin Vial. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Symlin Vial if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Symlin Vial is given as an injection under the skin, usually in the stomach area or upper thigh. Do not inject Symlin Vial into the arm, because it may not absorb properly. Rotate injection sites so you do not use the same site repeatedly. Do not mix Symlin Vial in the same syringe with insulin or inject it in the same area as insulin. Inject Symlin Vial at least 2 inches away from where you inject your insulin. If you store Symlin Vial in the refrigerator, allow it to warm to room temperature before you inject a dose. This may decrease the chance of a reaction at the injection site. Symlin Vial may affect the way other medicines are absorbed into your body. Some medicines may need to be taken at least 1 hour before or 2 hours after using Symlin Vial. Talk with your doctor or pharmacist about how you should take any other medicines with Symlin Vial. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. Continue to use Symlin Vial even if you feel well. Do not miss any doses. If you miss a dose of Symlin Vial, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Symlin Vial.

Important safety information: Dizziness may occur while you are using Symlin Vial. This effect may be worse if you take it with alcohol or certain medicines. Use Symlin Vial with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing low blood sugar. Nausea is a common side effect of Symlin Vial. Mild nausea is more likely during the first weeks of treatment and usually does not last long. Tell your doctor if nausea continues or is bothersome. Do NOT use Symlin Vial if your blood sugar is too low, you skip a meal, you plan to eat a meal with fewer than 250 calories or 30 grams of carbohydrates, you are sick and cannot eat your usual meal, you are having surgery or a medical test for which you cannot eat, or you are pregnant or breast-feeding and have not talked to your doctor. Do not use more than your prescribed dose of Symlin Vial without checking with your doctor. Using more than the prescribed dose may cause nausea and vomiting, and you may not be able to eat the amount of food you usually eat. If you use more of Symlin Vial than the prescribed dose, pay close attention to the amount of insulin use. You may have greater risk of developing low blood sugar. Contact your doctor or other health care provider for instructions. Tell your doctor or dentist that you take Symlin Vial before you receive any medical or dental care, emergency care, or surgery. Talk with your health care provider about all of your diabetes medicines and how to use them. Do not start, stop, or change the dose of any diabetes medicine unless your doctor tells you to. If you stop using Symlin Vial for any reason (eg, surgery, illness), contact your doctor. Follow your doctor's instructions for restarting Symlin Vial. Symlin Vial may increase the risk of severe low blood sugar caused by insulin. Low blood sugar may also occur if you use too much of Symlin Vial, use too much insulin, skip a meal, or exercise more than usual. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals. Carry an ID card at all times that says you take Symlin Vial. Monitor your blood sugar levels as directed by your health care provider. Most patients will monitor blood sugar before meals, after meals, and at bedtime. If your blood sugar is often higher or lower than it should be, check with your doctor. Follow the diet and exercise program given to you by your health care provider. Ask your health care provider what you should do if you miss a dose of your insulin. It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. If any of these occur, talk with your doctor. A change in your medicine may be needed. Lab tests, including fasting blood sugar levels and hemoglobin A1c, may be performed while you use Symlin Vial. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Symlin Vial should not be used in CHILDREN; safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Symlin Vial, contact your doctor. You will need to discuss the benefits and risks of using Symlin Vial while you are pregnant. It is not known if Symlin Vial is found in breast milk. If you are or will be breast-feeding while you are using Symlin Vial, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Symlin Vial:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased appetite; indigestion; minor redness, swelling, itching, or pain at the injection site; nausea; stomach pain; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); seizure; severe of persistent nausea; symptoms of low blood sugar (eg, chills, dizziness, drowsiness, fainting, fast heartbeat, headache, increased hunger, irritability, nervousness, sweating, tremor, trouble concentrating, weakness).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Symlin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; dizziness; flushing; severe nausea; vomiting.

Proper storage of Symlin Vial:

Store new (unused) vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store opened (used) vials in the refrigerator or at room temperature, up to 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Throw away used vials after 30 days, even if they still contain medicine. Do not use Symlin Vial if it has been frozen or heated above room temperature, or if it is expired. Keep Symlin Vial out of the reach of children and away from pets.

General information: If you have any questions about Symlin Vial, please talk with your doctor, pharmacist, or other health care provider. Symlin Vial is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Symlin Vial. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Symlin resources Symlin Side Effects (in more detail) Symlin Use in Pregnancy & Breastfeeding Symlin Drug Interactions Symlin Support Group 2 Reviews for Symlin - Add your own review/rating Compare Symlin with other medications Diabetes, Type 1 Diabetes, Type 2
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Triple Wormer



Dosage Form: FOR ANIMAL USE ONLY
TripleWormer™
(pyrantel pamoate/praziquantel)

FOR PUPPIES AND SMALL DOGS

Durvet Triple Wormer™ Flavored Chewables
Package contents: Blisters of 2 or 12 chewables

DRUG FACTS

Active Ingredients (in each chewable)

Pyrantel Pamoate (30mg) and Praziquantel (30mg)

Purpose

De-wormer for Small Dogs and Puppies Only (6.0 to 25 pounds)

Uses

For the treatment and control of

Roundworms (Toxocara canis, Toxascaris leonina) Hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) Tapeworms (Dipylidium caninum, Taenia pisiformis) Human Warning

Keep this and all medication out of the reach of children. To obtain product information, including a Material Safety Data Sheet (MSDS), call 1-800-821-5570.

When Using This Product:

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness. Durvet Triple Wormer™ Flavored Chewables are safe for use in puppies12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested. You May Notice

Vomiting, loose stools (with or without blood) and decreased activity following treatment. If you notice these signs, contact a veterinarian.

Directions

Each flavored chewable contains 30 mg of pyrantel pamoate and 30 mg of praziquantel. The dose for each drug is 2.27 mg per pound of body weight (5 mg/kg). Please refer to the following dosing table for help finding the right dose for your dog.

Durvet Triple Wormer™ Flavored Chewables Dosing Table Dog Weight Number of Chewables 6.0 to 12.0 pounds 1 12.1 to 25 pounds 2 More than 25 pounds Use the 114 mg size You should weigh your dog to make sure you are giving the right dose. Durvet Triple Wormer™ Flavored Chewables are palatable if offered by hand. If your dog does not voluntarily eat the chewable, you can hide the chewable in a small amount of food or place it in the back of the dog's mouth for forced swallowing. Make sure that the dog eats the complete dose. Watch the dog for a few minutes after dosing to make sure the chewable is not rejected. OTHER INFORMATION Recommended De-Worming Schedule

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. De-worming schedules may vary depending on the climate where you live and the activity of your dog.

Re-treatment

Re-treatment of your dog may be necessary as determined by laboratory fecal examination and/or if your dog is living where re-infections are likely to occur. Consult your veterinarian for assistance in the diagnosis and prevention of re-infection. In case of re-infection with tapeworms (Dipylidium caninum), consult your veterinarian for advice on how to remove fleas from the dog and the environment.

Storage

Store at controlled room temperature of 59-86°F (15-30°C).

Questions? Comments?

To report a suspected adverse reaction, call 1-800-821-5570

If you have questions or comments about this product, please write: Durvet, Inc., PO Box 279, Blue Springs, MO 64013

Manufactured for:
Durvet, Inc., 100 S.E. Magellan Drive, Blue Springs, MO 64014

MADE IN USA

NADA141-261, Approved by FDA ACAV P002632-1 06/07

PRINCIPAL DISPLAY PANEL - 30 mg Tablet Carton

NDC 30798-185-61

FOR PUPPIES AND SMALL DOGS

TripleWormer™
(pyrantel pamoate/praziquantel)

2
tablets

CHEWABLE FLAVORED DOG DE-WORMER TABLETS

Broad Spectrum
De-Wormer

For Puppies & Small Dogs
6 lbs. to 25 lbs.

For the treatment and control of:

roundworms (Toxocara canis, Toxascaris leonina);

hookworms (Ancylostoma caninum, Ancylostoma
braziliense, Uncinaria stenocephala);

tapeworms (Dipylidium caninum,Taenia
pisiformis) in dogs and puppies.

Active ingredient: Each flavored chewable contains
30 mg pyrantel pamoate and 30 mg praziquantel.

KEEP OUT OF REACH OF CHILDREN

FOR USE ONLY AS DIRECTED ON PACKAGE INSERT & BACK PANEL

NET CONTENTS: 2 FLAVORED TABLETS
NADA #141-261, APPROVED BY FDA

durvet


Triple Wormer 
pyrantel pamoate and praziquantel  tablet, chewable Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 30798-185 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pyrantel pamoate (pyrantel) pyrantel pamoate 30 mg praziquantel (praziquantel) praziquantel 30 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color BROWN Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 30798-185-61 2 TABLET In 1 BOX, UNIT-DOSE None 2 30798-185-71 12 TABLET In 1 BOX, UNIT-DOSE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141261 03/06/2010
Labeler - Durvet, Inc. (056387798) Registrant - Virbac AH, Inc. (131568396) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 MANUFACTURE Revised: 03/2010Durvet, Inc.

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