Oti-Pack E syringe treatment
 

Pills
 

ED Pills

ED Drugs
 

H. pylori eradication agents


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.

Agents used in treatment of Helicobacter Pylori are medicines used for stomach acid inhibition, combined with antibacterial agents. Treatment is for one week with a proton pump inhibitor or an antacid (or antisecretory agents), and two appropriate antibacterial agents. This one week triple therapy does give a good eradication rate.

See also

Medical conditions associated with H. pylori eradication agents:

Helicobacter Pylori Infection Drug List: Prevpac-Therapy-Pack Pylera Helidac-Therapy-Pack
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NEULASTA


Neulasta 6 mg solution for injection in a pre-filled syringe

pegfilgrastim

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 Neulasta is and what it is used for 2. Before you use Neulasta 3. How to use Neulasta 4. Possible side effects 5. How to store Neulasta 6. Further information What Neulasta Is And What It Is Used For

Neulasta is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important as they help your body fight infection. These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.

Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.

Before You Use Neulasta Do not use Neulasta if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of Neulasta. Take special care with Neulasta

Please tell your doctor:

if you experience a cough, fever and difficulty breathing;
if you have sickle cell anaemia;
if you get left upper abdominal pain or pain at the tip of your shoulder;
if you have an allergy to latex. The needle cover on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions. Using other medicines

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Neulasta has not been tested in pregnant women. It is important to tell your doctor if you:

are pregnant;
think you may be pregnant; or
plan to become pregnant.

You must stop breast feeding if you use Neulasta.

Driving and Using Machines

The effect of Neulasta on the ability to drive or use machines is not known.

Important information about some of the ingredients of Neulasta

Neulasta contains sorbitol (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Neulasta. Neulasta is essentially sodium-free.

How To Use Neulasta

Neulasta is for use in adults aged 18 and over.

Always take Neulasta exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

Do not shake Neulasta vigorously as this may affect its activity.

Injecting Neulasta yourself

Your doctor may decide that it would be more convenient for you to inject Neulasta yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

For further instructions on how to inject yourself with Neulasta, please read the section at the end of this leaflet.

If you use more Neulasta than you should

If you use more Neulasta than you should contact your doctor, nurse or pharmacist.

If you forget to inject Neulasta

If you have forgotten a dose of Neulasta, you should contact your doctor to discuss when you should inject the next dose.

NEULASTA Side Effects

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

A very common side effect (likely to occur in more than 1 in 10 patients) is bone pain. Your doctor will tell you what you can take to ease the bone pain.

Common side effects (likely to occur in fewer than 1 in 10 patients) include; pain and redness at the site of the injection, headaches, and general aches and pains in the joints, muscles, chest, limbs, neck or back. An uncommon side effect (likely to occur in fewer than 1 in 100 patients) is nausea.

Allergic-type reactions to Neulasta, including redness and flushing, skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face), have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.

Increased spleen size and very rare cases (likely to occur in fewer than 1 in 10,000 patients) of spleen rupture have been reported after the use of Neulasta. Some cases of splenic rupture were fatal.

It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.

Rare (likely to occur in fewer than 1 in 1000 patients) cases of breathing problems have been reported after taking G-CSFs. If you have a cough, fever and difficulty breathing please tell your doctor.

Some changes may occur in your blood, but these will be detected by routine blood tests. Your platelet count may become low which might result in bruising. Your white blood cell count may become high for a short period of time.

Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role.

Very rarely (likely to occur in fewer than 1 in 10,000 patients) cutaneous vasculitis (inflammation of the blood vessels in the skin) has occurred in patients receiving Neulasta.

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 Neulasta

Keep out of the reach and sight of children.

Do not use Neulasta after the expiry date which is stated on the box and on the syringe label (EXP). The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

You may take Neulasta out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.

Do not freeze. Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.

Keep the container in the outer carton in order to protect from light.

Do not use Neulasta if you notice it is cloudy or there are particles in it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Neulasta contains

Neulasta contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.

The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.

The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.

What Neulasta looks like and contents of the pack

Neulasta is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).

Each pack contains 1 pre-filled syringe. The syringes are provided either with or without a blister wrapping. It is a clear, colourless liquid.

Marketing Authorisation Holder and Manufacturer: Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands Further information

If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Amgen Limited Tel: +44 (0)1223 420305

This leaflet was last approved in December 2009.

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.

Instructions for injecting with the Neulasta pre-filled syringe

This section contains information on how to give yourself an injection of Neulasta. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist. If you have questions about how to inject, please ask your doctor, nurse, pharmacist for assistance.

How do you, or the person injecting you, use Neulasta pre-filled syringe?

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.

Equipment that you need

To give yourself a subcutaneous injection you will need:

a pre-filled syringe of Neulasta; and
alcohol wipes or similar. What should I do before I give myself a subcutaneous injection of Neulasta? 1. Remove from the refrigerator.
2. Do not shake the pre-filled syringe.
3. Do not remove the cover from the syringe until you are ready to inject.
4. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
5. Check the appearance of Neulasta. It must be a clear and colourless liquid. If there are particles in it, you must not use it.
6. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Neulasta in any other way (for example, do not warm it in a microwave or in hot water).
7. Wash your hands thoroughly.
8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach. How do I prepare my Neulasta injection?

Before you inject Neulasta you must do the following:

1. Hold the syringe barrel and gently take the cover from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.
2. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
3. You can now use the pre-filled syringe. Where should I give my injection?

The most suitable places to inject yourself are:

the top of your thighs; and
the abdomen, except for the area around the navel.

If someone else is injecting you, they can also use the back of your arms.

How do I give my injection? 1. Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
2. Put the needle fully into the skin as shown by your nurse or doctor.
3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
4. Inject the liquid slowly and evenly, always keeping your skin pinched.
5. After injecting the liquid, remove the needle and let go of your skin.
6. If you notice a spot of blood at the injection site dab away with a cotton ball or tissues. Do not rub the injection site. If needed, you may cover the injection site with a bandage.
7. Only use each syringe for one injection. Do not use any Neulasta that is left in the syringe.

Remember

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes Do not put the cover back on used needles.
Keep used syringes out of the reach and sight of children.
The used syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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GlucaGen Hypokit 1 mg


GlucaGen HypoKit 1mg

[Glucagon biosynthetic (rys)]

What you should know about GlucaGen Hypokit 1mg

Please read this leaflet carefully before using this medicine. This leaflet does not contain all of the information about the product that you may need to know, so please ask your doctor or pharmacist if you have any questions.

What is in your medicine

The active ingredient is glucagon biosynthetic (rys) 1mg. Other ingredients are lactose monohydrate, hydrochloric acid, sodium hydroxide and water for injections. GlucaGen HypoKit 1mg consists of a powder for injection (GlucaGen 1mg) with accompanying diluent (Diluent for GlucaGen 1mg) for preparation of glucagon injection. The pack contains:

1 vial with white powder containing 1 mg glucagon (rys) 1 pre-filled syringe containing 1ml diluent (water for injections, Ph.Eur.) for reconstitution

The reconstituted product contains 1mg/ml (1iu/ml) glucagon (rys).

Glucagon is a hyperglycaemic agent (i.e. increases blood glucose). It works by releasing glucose into the bloodstream from glycogen stored in the liver. Independently of this effect, glucagon also inhibits the motility (natural movement) of the smooth muscles in the gastrointestinal tract.

The marketing authorisation holder and manufacturer is: Novo Nordisk A/S Novo All? DK-2880 Bagsvaerd Denmark What is GlucaGen HypoKit 1mg for?

Glucagon is used for the treatment of severe hypoglycaemic reactions (“hypo” or low blood sugar) which may occur if you have diabetes and are treated with insulin. The glucagon acts by releasing sugar into the bloodstream from glucose (or glycogen) stored in the liver. Glucagon is also used in hospitals to temporarily stop movement of the bowels during examinations of the gastrointestinal tract.

Before you take GlucaGen Conditions where GlucaGen should not be used

GlucaGen should not be used if you have phaeochromocytoma (high blood pressure due to a tumour near the kidney). You should not use GlucaGen if you are allergic to glucagon or any of the constituents (these are listed above).

Precautions

For GlucaGen to work in the treatment of hypoglycaemia, sugar (as glycogen) must be present in your liver. GlucaGen will not work properly if you are fasting, if you have underactive adrenal glands, hypoglycaemia lasting a long time or hypoglycaemia caused by drinking too much alcohol. Because GlucaGen depletes glycogen stores, you must be given sugar by mouth as soon as you are able to take it after you have responded to the treatment or after the diagnostic procedure is over. This will prevent the occurrence of secondary hypoglycaemia. Take extra care if you use GlucaGen and have an insulinoma or glucagonoma (tumours of the pancreas which secrete insulin or glucagon respectively). It should be kept in mind that glucagon has the opposite effect to insulin. Caution must be observed when GlucaGen is used in diabetics, or in elderly patients with a heart condition, in connection with endoscopy or radiography. Other medicines

Indomethacin (used in treatment of rheumatic diseases and gout) may prevent or even reverse the hyperglycaemic effect of glucagon. The effect of injected GlucaGen is not known to be influenced by medicines other than insulin or indomethacin.

GlucaGen may increase the anticoagulant effect of warfarin.

Pregnancy and lactation

Glucagon does not cross the placenta and may be used in the treatment of severe hypoglycaemia during pregnancy.

Breast-feeding following treatment of severe hypoglycaemic reactions with GlucaGen does not put your baby at risk.

Driving or operating machinery

GlucaGen is not known to produce any effect on your ability to drive or operate machinery. However, you should not drive or operate machinery immediately following recovery from severe hypoglycaemia because symptoms, such as blurred vision, may still be present and because of the possibility of recurrence of hypoglycaemia.

How to take GlucaGen GlucaGen is given by injection; it may be given subcutaneously, intramuscularly or intravenously. Before injection, a solution of Glucagon must be prepared using the diluent provided in the pack. Carefully read “Preparing the solution for injection”. Following reconstitution, if the solution is not clear (viscous appearance or solid particles present) it must not be used for injection. Treatment of severe hypoglycaemia

Administration to the patient by relatives or friends

Glucagon is often prescribed for treatment of hypoglycaemia so that close friends or relatives can give the injection if you become hypoglycaemic and are unable to take sugar by mouth. Under these circumstances glucagon is usually injected under the skin or into the upper and outer muscle of the thigh, but follow your doctor’s instructions on how to give the injection. Follow your doctor’s instructions concerning the appropriate dose for treating hypoglycaemia. The recommended dose for treatment of hypoglycaemia in diabetics is 1mg ( = 1ml, all of solution) for adults and children over 25kg or aged 6-8 years and 0.5mg ( = ?ml, half of solution) for children under 25kg or aged 6-8 years. Following injection of glucagon, carbohydrate must be given (eg glucose tablets or sugar) by mouth as soon as sufficient recovery has taken place. This will restore the stored sugar (glycogen) in the liver and prevent the blood sugar falling again. If recovery has not taken place within 10 minutes of the glucagon injection a doctor must be called immediately so that intravenous glucose can be given. Make sure that your relatives or close friends know that if you become unconscious medical assistance must always be sought.

Administration by medical personnel

Administer 1mg (adults and children over 25kg or aged 6-8 years) or 0.5mg (children below 25kg or aged 6-8 years) by subcutaneous, intramuscular, or intravenous injection. If the patient does not respond within 10 minutes a medical doctor must be contacted and intravenous glucose should be given. When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia. Diagnostic Indications

Examination of the Gastrointestinal Tract

(a)The dose ranges from 0.2 to 2mg depending on the diagnostic techniques used and the route of administration. The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2 to 0.5mg given intravenously or 1mg given intramuscularly; the usual dose to relax the colon is 0.5 to 0.75mg intra-venously or 1 to 2mg intramuscularly.
Onset of action after an intravenous injection of 0.2-0.5mg occurs within one minute and the duration of effect is between 5 and 20 minutes depending on the organ under examination. The onset of action after an intramuscular injection of 1 - 2mg occurs after 5-15 minutes and lasts approximately 10-40 minutes depending on the organ. (b)In computerised tomography (CT), nuclear magnetic resonance scanning (NMR) and digital subtraction angiography (DSA) intravenous doses of up to 1mg are used.

When the diagnostic procedure is completed, give oral carbohydrate to restore the liver glycogen and prevent occurrence of secondary hypoglycaemia.

Preparing the solution for injection The GlucaGen 1mg vial has a protective, tamper-evident plastic cap. This must be pushed off before use. The cap cannot be replaced once taken off. If the cap is not securely fastened to a new vial the pack should be returned to the pharmacy. 1 Push the orange plastic cap off the vial. Pull the needle cover off the syringe and insert the needle through the rubber disc of the vial. Inject all of the liquid from the syringe into the vial.
2 Without withdrawing the syringe and needle, gently shake the vial until the GlucaGen is completely dissolved and the solution is clear. Do not use if the solution has a viscous appearance or there are solid particles present. 3 Make sure that the plunger is completely down. Draw back all of the solution into the syringe. Be careful that the plunger is not pulled out of the syringe.
4 The solution is used for injection. Ensure there is no air remaining in the syringe before giving the injection. When the patient responds administer oral carbohydrate (eg dextrosol, sweet biscuits or a sweet drink) to prevent a further “hypo”. Possible problems with GlucaGen treatment Side effects Severe side effects are very rare, although nausea and vomiting may occur occasionally, especially with doses above 1mg or with rapid injection (less than 1 minute). In rare cases low blood pressure (you may feel faint or light headed) may occur up to 2 hours after use in connection with endoscopy. You may have a rapid heartbeat for a short time after injection of GlucaGen. Side effects suggesting toxicity of GlucaGen have not been reported. If you experience a rash, itching or shortness of breath following an injection of GlucaGen contact your doctor immediately and do not use the product again until your doctor has advised you that it is safe to do so. If you experience any other reaction which is likely to have been caused by GlucaGen please tell your doctor or pharmacist. Overdose

Overdosage of GlucaGen may cause nausea and vomiting. Serum potassium levels may also decrease and should be monitored and corrected if necessary.

Storage of GlucaGen HypoKit 1mg Store your packs of GlucaGen HypoKit 1mg in a refrigerator at 2 to 8°C. Do not freeze. Protect from light. A pack carried for use may be kept at normal surrounding temperature (maximum 25°C) for up to 18 months. The expiry date printed on the outside of the pack is for storage in a refrigerator. Do not use the GlucaGen HypoKit 1mg after this date. If you are keeping a pack at normal surrounding temperatures, write the date when you take it out of the refrigerator on the outside. If you have not used the GlucaGen in the meantime, discard the pack after 18 months from this date or at the expiry date, whichever is the sooner. The glucagon solution must be prepared immediately prior to use. Any portion of the contents remaining after use should be discarded. Keep your medicine out of the reach of children.

Date of leaflet preparation: October 2001

The address of Novo Nordisk in the UK is:

Novo Nordisk Limited Broadfield Park Brighton Road Crawley West Sussex RH11 9RT

GlucaGen Hypokit is a trademark owned by Novo Nordisk A/S, Denmark

© 2000/2002

Novo Nordisk A/S

8-9402-01-005-1


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Sentry HC Worm X



Dosage Form: FOR ANIMAL USE ONLY
Broad Spectrum De-Wormer Chewable Tablets for Large Dogs INDICATIONS & USAGE

For Removal of Hookworms in Puppies and Dogs

Ancylostoma caninum Uncinaria stenocephala For Removal of Large Roundworms (Ascarids) in Puppies and Dogs
Toxocara canis Toxascaris leonina To Prevent Reinfection of Large Roundworms in Puppies, Adult Dogs and Lactating Bitches After Whelping
Toxocara canis ACTIVE INGREDIENT (in each chewable) Pyrantel Pamoate (113.5 mg) How is Sentry HC Worm X Supplied Net Contents:    2 Tablet Count
Net Contents:    4 Tablet Count
Net Contents:  12 Tablet Count STORAGE Store at controlled room temperature of 59-86 degrees F (15-30 degrees C). PACKAGE LABEL PRINCIPAL DISPLAY PANEL Sentry HC Worm X
Distributed by:
Sergeant's Pet Care Products, Inc., Omaha NE 68130
www.sentrypetcare.com
ANADA #200-281, Approved by FDA
Sentry HC Worm X 
pyrantel pamoate  tablet, chewable Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-402 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 113.5 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor LIVER (Pork Liver Powder) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 21091-402-02 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 2 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-02) 2 21091-402-04 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 4 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-04) 3 21091-402-12 6 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 12 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-12)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200281 01/16/2008
Labeler - Sergeant's Pet Care Products, Inc. (876995171) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 manufacture Revised: 11/2010Sergeant's Pet Care Products, Inc.

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Begrivac 2010 / 2011 suspension for injection in pre-filled syringe


1. Name Of The Medicinal Product

Begrivac® 2010/2011 / suspension for injection in pre-filled syringe

Influenza vaccine (split virion, inactivated)

2. Qualitative And Quantitative Composition

Influenza virus (inactivated, split) of the following strains*:

A/California/07/2009 (H1N1) - derived strain used NYMC X-181

15 micrograms HA**

A/Perth/16/2009 (H3N2) - like strain used NYMC X-187

derived from A/Victoria/210/2009

15 micrograms HA**

B/Brisbane/60/2008 - derived strain used NYMC BX-35

15 micrograms HA**

----------------------------------------------------------------------------------------------------------------------

per 0.5 ml dose

* propagated in fertilised hen's eggs from healthy chicken flocks .

** haemagglutinin

This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2010/2011 season.

For a full list of excipients see section 6.1.

3. Pharmaceutical Form

Suspension for injection in pre-filled syringe.

Slightly opalescent.

4. Clinical Particulars 4.1 Therapeutic Indications

Prophylaxis of influenza, especially in those who run an increased risk of associated complications.

The use of Begrivac 2010/2011 should be based on official recommendations.

4.2 Posology And Method Of Administration

Adults and children from 36 months: 0.5 ml.

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.

For children, who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Immunisation should be carried out by intramuscular or deep subcutaneous injection.

For instructions for preparation, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin.

The vaccine may contain residues of polymyxin B, formaldehyde, diethylether or polysorbate 80.

Immunisation shall be postponed in patients with febrile illness or acute infection.

4.4 Special Warnings And Precautions For Use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Begrivac 2010/2011 should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Begrivac 2010/2011 may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immuno-suppressant treatment.

Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the IgM response by the vaccine.

4.6 Pregnancy And Lactation

The limited data from vaccinations in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

Begrivac 2010/2011 may be used during lactation.

4.7 Effects On Ability To Drive And Use Machines

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

4.8 Undesirable Effects

Adverse reactions observed from clinical trials

The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 – 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination.

The following undesirable effects have been observed during clinical trials with the following frequencies:

Very common (>1/10); common (

Nervous system disorders

Common:

Headache*

Skin and subcutaneous tissue disorders

Common:

Sweating*

Musculoskeletal and connective tissue disorders

Common:

Myalgia, arthralgia*

General disorders and administration site conditions

Common:

Fever, malaise, shivering, fatigue. Local reactions: redness, swelling, pain, ecchymosis, induration.*

* These reactions usually disappear within 1-2 days without treatment.

Adverse reactions reported from post-marketing surveillance

Adverse reactions reported from post-marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:

Blood and lymphatic system disorders:

Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders:

Allergic reactions, in rare cases leading to shock, angioedema

Nervous system disorders:

Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barr? syndrome

Vacsular disorders:

Vasculitis associated in very rare cases with transient renal involvement.

Skin and subcutaneous tissue disorders:

Generalised skin reactions including pruritus, urticaria or non-specific rash.

4.9 Overdose

Overdosage is unlikely to have any untoward effect.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Influenza vaccine

ATC-Code: J07BB02

Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Buffer solution (pH = 7.2) containing: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

1 year

6.4 Special Precautions For Storage

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

0.5 ml suspension in pre-filled syringe (Type I glass) with plunger stopper (bromobutyl rubber) with or without needle – in pack sizes of 1, 10 or 20 (2 ? 10)

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The vaccine should be allowed to reach room temperature before use.

Shake before use.

For children, when a dose of 0.25 ml is indicated, the following procedure is recommended:

Syringe without mark for the 0.25 ml dose:

The pre-filled syringe should be held in the upright position and half of the volume should be eliminated. The remaining volume should be injected.

Syringe with a mark for the 0.25 ml dose:

Discard half the contained volume up to the mark (little black line indicated on the syringe barrel below the label), before injection.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Novartis Vaccines and Diagnostics GmbH

P.O. Box 1630

D-35006 Marburg

8. Marketing Authorisation Number(S)

national:

MRP: DE/H/125/01

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorization (national): 8. August 1996

Renewal of the authorization: 20. February 2008

10. Date Of Revision Of The Text

May 2010


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Agrippal


1. Name Of The Medicinal Product

AGRIPPAL, Suspension for injection in pre-filled syringe

Influenza vaccine (surface antigen, inactivated)

(2010/2011 SEASON)

2. Qualitative And Quantitative Composition

Influenza virus surface antigens (haemagglutinin and neuraminidase), of the following strains*:

A/California/07/2009 (H1N1) - derived strain used NYMC X-181

15 micrograms HA**

A/Perth/16/2009 (H3N2) - like strain used NYMC X-187 derived from A/Victoria/210/2009

15 micrograms HA**

B/Brisbane/60/2008

15 micrograms HA**

Per 0.5 ml dose

* propagated in fertilized hens' eggs from healthy chicken flocks

** haemagglutinin

This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the 2010/2011 season.

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Suspension for injection in pre-filled syringe.

The vaccine appears as a clear liquid.

4. Clinical Particulars 4.1 Therapeutic Indications

Prophylaxis of influenza, especially in those who run an increased risk of associated complications.

The use of AGRIPPAL should be based on official recommendations.

4.2 Posology And Method Of Administration

Adults and children from 36 months: 0.5 ml

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.

For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Immunisation should be carried out by intramuscular or deep subcutaneous injection.

For instructions for preparation, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin.

The vaccine may contain residues of the following substances, e.g. kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.

Immunisation shall be postponed in patients with febrile illness or acute infection.

4.4 Special Warnings And Precautions For Use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

AGRIPPAL should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

AGRIPPAL may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA results. The transient false positive reactions could be due to the IgM response by the vaccine.

4.6 Pregnancy And Lactation

The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

AGRIPPAL may be used during lactation.

4.7 Effects On Ability To Drive And Use Machines

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

4.8 Undesirable Effects

ADVERSE REACTIONS OBSERVED FROM CLINICAL TRIALS

The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 – 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination.

The following undesirable effects have been observed during clinical trials with the following frequencies:

Very common (

Nervous system disorders

Common (:

Headache*

Skin and subcutaneous tissue disorders

Common (:

Sweating*

Musculoskeletal and connective tissue disorders

Common (:

Myalgia, arthralgia*

General disorders and administration site conditions

Common (:

Fever, malaise, shivering, fatigue.

Local reactions: redness, swelling, pain, ecchymosis, induration.*

*These reactions usually disappear within 1-2 days without treatment.

ADVERSE REACTIONS REPORTED FROM POST-MARKETING SURVEILLANCE

Adverse reactions reported from post marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:

Blood and lymphatic system disorders:

Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders:

Allergic reactions, in rare cases leading to shock, angioedema

Nervous system disorders:

Neuralgia, paraesthesiae, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain-Barr? syndrome

Vascular disorders:

Vasculitis associated in very rare cases with transient renal involvement

Skin and subcutaneous tissue disorders:

Generalised skin reactions including pruritus, urticaria or non-specific rash

4.9 Overdose

Overdosage is unlikely to have any untoward effect.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Influenza vaccine, ATC code: J07BB02.

Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium chloride

Potassium chloride

Potassium dihydrogen phosphate

Disodium phosphate dihydrate

Magnesium chloride hexahydrate

Calcium chloride dihydrate

Water for Injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

1 year.

6.4 Special Precautions For Storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

0.5 ml of suspension in pre-filled syringe (type I glass) with needle (23 G, 1” or 25 G, 1” or 25 G, 5/8”), equipped with a rubber plunger stopper – pack size of 1 or 10.

0.5 ml of suspension in pre-filled syringe (type I glass) without needle, equipped with a rubber plunger stopper – pack size of 1 or 10.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The vaccine should be allowed to reach room temperature before use.

Shake before use.

If half a dose (0.25 ml) is to be administered, discard half the contained volume (up to the mark indicated on the syringe barrel), before injection.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina 1, SIENA, Italy

8. Marketing Authorisation Number(S)

PL 13767/0004

9. Date Of First Authorisation/Renewal Of The Authorisation

22 December 1998

22 January 2009

10. Date Of Revision Of The Text

06/2010


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SOMAVERT 10mg, 15mg and 20mg powder and solvent for solution for injection


SOMAVERT 10 mg powder and solvent for solution for injection

SOMAVERT 15 mg powder and solvent for solution for injection

SOMAVERT 20 mg powder and solvent for solution for injection

Pegvisomant

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 SOMAVERT is and what it is used for 2. Before you use SOMAVERT 3. How to use SOMAVERT 4. Possible side effects 5. How to store SOMAVERT 6. Further information What Somavert Is And What It Is Used For

SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders.

SOMAVERT is a product of biotechnology. The active substance in SOMAVERT, pegvisomant is known as a growth hormone receptor antagonist. These substances decrease the action of GH and levels of IGF-I circulating in the blood.

Before You Use Somavert Do not use SOMAVERT If you are allergic (hypersensitive) to pegvisomant or to any of the other ingredients of SOMAVERT. Take special care with SOMAVERT: If you experience disturbed vision or headaches while using SOMAVERT you must contact your doctor immediately. Your doctor or nurse will monitor the levels of IGF-I (Insulin-like growth factors) circulating in the blood and adjust the dose of SOMAVERT if necessary. Your doctor should also monitor your adenoma (benign tumour). Your doctor or nurse will monitor the level of liver enzymes in the blood every 4-6 weeks for the first six months of treatment with SOMAVERT. Administration of SOMAVERT should be discontinued if signs of liver disease persist. If you are diabetic, your doctor may need to adjust the amount of insulin or other medicines you are using. Female patients should use adequate contraception as fertility may be increased. See also the section about Pregnancy below. Using other medicines

You must tell your doctor if you have previously used other medicines for the treatment of acromegaly or medicines for the treatment of diabetes.

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

As part of your treatment you may be given other medicines. It is important to keep using all your medicines as well as SOMAVERT unless you are told otherwise by your doctor or pharmacist.

Pregnancy and breast-feeding:

The effects of SOMAVERT in pregnant women are not known, and so the use of SOMAVERT in pregnant women is not recommended. You are advised to not become pregnant while taking SOMAVERT therapy. In case you become pregnant, you must consult your doctor. Ask your doctor or pharmacist for advice before taking any medicine.

It is not known if SOMAVERT passes into breast milk. You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.

Driving and using machines:

No studies on the effects on the ability to drive and use machines have been performed.

Important information about some of the ingredients of SOMAVERT

This medicinal product contains less than 1 mmol sodium (23 mg) per 10 mg dose, less than 1 mmol sodium (23 mg) per 15 mg dose, or less than 1 mmol sodium (23 mg) per 20 mg dose i.e. essentially ‘sodium-free’.

How To Use Somavert

Always inject SOMAVERT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

A starting dose of 80 mg of SOMAVERT will be given subcutaneously (just under the skin) by your doctor. Following this, the usual daily dose of SOMAVERT is 10 mg, which is given by subcutaneous injection (just under the skin).

Every four to six weeks your doctor will make appropriate dose adjustments, made in increments of 5 mg pegvisomant/day, based on your so-called serum IGF-I levels to maintain an optimal therapeutic response.

Method and route of administration

SOMAVERT is injected under the skin. The injection can be self-administered or given by another person, for example your doctor or his/her assistant. The detailed instructions on injection procedure provided at the end of this leaflet must be followed. You should continue to inject SOMAVERT for as long as instructed by your doctor.

SOMAVERT must be dissolved before use. The injection must not be mixed in the same syringe or vial as any other medicine.

Fatty tissue of the skin can build-up at the site of injection. To avoid this, use a slightly different place for your injection each time, as described in Step 2 of the ‘Instructions for Preparing and Giving an Injection of Somavert’ section of this leaflet. This gives your skin and the area under your skin time to recover from one injection before it receives another one in the same place.

If you have the impression that the effect of SOMAVERT is too strong or too weak, talk to your doctor or pharmacist.

If you inject more SOMAVERT than you should

If you accidentally inject more SOMAVERT than told to by your doctor it is unlikely to be serious, but you should contact your doctor or pharmacist immediately.

If you forget to use SOMAVERT

If you forget to give yourself an injection you should inject the next dose as soon as you remember and then continue to inject SOMAVERT as prescribed by your doctor. Do not inject a double dose to make up for forgotten individual doses

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

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

Common side effects (likely to occur in fewer than 1 in 10 patients) include: Headache, dizziness, sleepiness, uncontrolled trembling. Diarrhoea, constipation, feeling sick, being sick, feeling bloated, indigestion, gas. Sweating, itching, rash. Joint pain, muscle pain, swelling of the extremities. Increased blood cholesterol, weight gain, increased blood glucose, increased appetite. Increased blood pressure. Bruising or bleeding at injection site, soreness or swelling at injection site, build up of fat below the surface of the skin at injection site. Flu-like illness, fatigue. Increased levels of substances that measure the function of the liver. These can be seen in the results of blood tests. Abnormal dreams, problems sleeping. Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include: Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed. Decreased sense of touch, abnormal sense of taste, migraine. Eyestrain, eye pain, inner ear problems. Shortness of breath. Dry mouth, increased saliva, tooth problems, hemorrhoids. Blood in the urine, protein in the urine, increased urine, kidney problems. Facial swelling, dry skin, tendency to bruise, night sweats. Arthritis. Increased fatty substances in the blood, decreased blood glucose. Fever, weakness, feeling abnormal, impaired healing. Anger, lack of interest, feeling confused, increased sex drive, panic attack, loss of memory.

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.

About 17% of patients will develop antibodies to growth hormone during treatment. The antibodies do not seem to stop SOMAVERT from working.

How To Store Somavert

Keep out of the reach and sight of children

Do not use SOMAVERT after the expiry date which is stated on the vial and the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C) Do not freeze. Keep the vials in the outer carton in order to protect from light.

After preparing the SOMAVERT solution it must be used immediately. Carefully dispose of any SOMAVERT solution that has not been injected.

Do not use SOMAVERT if you notice that the solution is cloudy or contains particulate matter.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

Further Information What SOMAVERT contains The active substance is pegvisomant. One vial of powder contains either10 mg, 15 mg, or 20 mg. After reconstitution with 1 ml of solvent, 1 ml of the clear solution contains either 10 mg, 15 mg, or 20 mg pegvisomant. The other ingredients are glycine, mannitol (E421), sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate. The solvent is water for injections. One vial of solvent contains 8 ml water for injections. What SOMAVERT looks like and contents of the pack

SOMAVERT is presented as a powder and a solvent for injection, in a vial. Powder in a vial (either10 mg, 15 mg, or 20 mg pegvisomant) and solvent in a vial (8 ml). Pack sizes of 1 and 30. Not all pack sizes are marketed. The powder is white and the solvent is clear and colourless.

Marketing Authorisation holder: Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom Manufacturer: Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs Belgium

For any information about this medicine product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Pfizer Limited Tel:+44 (0)1737 331111

This leaflet was last approved on: December 2007

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. There are also links to other websites about rare diseases and treatments

Instructions For Preparing And Giving An Injection Of Somavert Introduction

The following instructions explain how to prepare and inject SOMAVERT. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the technique of self-injection. Do not attempt to self-inject until you are sure that you understand how to prepare and give an injection.

The powder must be dissolved with the solvent before use.

This injection should not be mixed in the same syringe or vial with any other medicine.

Step 1. Choosing The Method For Preparing The Somavert Solution

There are 2 methods for preparing the SOMAVERT solution. Please discuss with your healthcare professional which method is best for you:

a) The Vial Adapter Method (MIXJECT), b) The Non-Vial Adapter Method. a) VIAL ADAPTER METHOD (MIXJECT)

GETTING STARTED

Wash your hands thoroughly. Collect: 1 vial of powder (SOMAVERT), 1 vial of solvent (Water for Injections), 1 luer-lock syringe of 1ml (for both reconstituting the SOMAVERT solution and giving the injection) is recommended. However, other sizes and types of syringes can be used for the preparation and injection of SOMAVERT. Please consult your healthcare professional for further information. 2 MIXJECT vial adapters, 1 detachable needle (25 to 30 gauge), Alcohol or antiseptic swabs and a proper disposal container for used needles and syringes. Inspect the expiry dates on both the vial label and the syringe label. They should not be used after the month and year shown.

After reconstitution with 1 ml of solvent, 1 ml of the clear solution contains either 10 mg, 15 mg, or 20 mg pegvisomant.

PREPARING THE SOMAVERT DOSE FOR INJECTION

1. Remove the protective plastic caps from the tops of both vial of solvent and vial of SOMAVERT (Fig. 1). Take care not to touch the rubber vial stoppers. At this point, the stoppers are clean. If the stoppers are touched or otherwise contaminated, you must clean them with an antiseptic or alcohol swab before inserting a vial adapter through the stopper.
2. Open only one of the vial adapters by peeling back the protective cover. Leave the adapter in the plastic packaging and do not touch the spike of the adapter. 3. While holding the plastic adapter packaging, place the adapter over the solvent vial and insert the piercing spike of the vial adapter all the way in through the rubber stopper of the solvent vial, using a pushing motion. (Fig. 2). Remove the plastic packaging from the vial adapter and discard. 4. Remove the syringe from the protective packaging. Pull the plunger of the syringe out to the 1 ml mark. Hold the solvent vial, placed on a flat surface, with one hand and connect the tip of the syringe to the vial adapter by twisting the syringe on the vial adapter clockwise (Fig. 3). Gently push the plunger until the air is injected into the vial.

ADDING SOLVENT

5. Securely grasp the solvent vial, adapter and syringe assembly. Carefully turn the vial, adapter and syringe assembly upside down. Bring to eye level (Fig. 4).
6. Slide one hand carefully down the solvent vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper part of the syringe. With the other hand, slowly pull the syringe plunger down to slightly past the 1 ml mark.

Examine the solution in the syringe for air bubbles. If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger up to eject only the air bubbles back into the vial. Recheck that 1 ml of solvent remains in the syringe.

Carefully turn the solvent vial, adapter and syringe assembly and place them upright on a clean surface. Do not remove the syringe from the adapter at this point.

7. As explained for the first vial adapter, open now the second vial adapter by peeling back the protective cover. Do not touch the vial adapter. Do not remove the adapter from the plastic packaging. While holding the plastic adapter packaging, place the adapter over the SOMAVERT vial and insert the piercing spike of the vial adapter all the way in through the rubber stopper of the SOMAVERT vial, using a pushing motion (Fig. 5). Remove the plastic packaging from the vial adapter and discard. 8. Disconnect the syringe from the solvent vial adapter and attach it to the vial adapter on the vial of SOMAVERT. Tilt the vial of SOMAVERT, adapter and syringe assembly to the side and gently inject the solvent down the inner side of the vial of SOMAVERT (Fig 6). Discard the solvent vial as directed by your healthcare provider. 9. Hold the vial of SOMAVERT with the adapter and syringe still attached upright between your hands and gently roll it to dissolve the powder (Fig. 7). DO NOT SHAKE THE VIAL. The solution should be clear after the powder is dissolved. If the solution is cloudy or hazy, do not inject it. Notify your pharmacy and request a replacement vial. Do not throw the vial away because the pharmacy may request that you return it.

PREPARING THE INJECTION

10. Securely grasp the vial containing the SOMAVERT reconstituted solution, vial adapter and syringe assembly. Carefully turn the vial, adapter and syringe assembly upside down. Bring to eye level. 11. As before, slide one hand carefully down the vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper portion of the syringe. With the other hand, slowly pull the syringe plunger down to withdraw the full contents of the vial (1 ml). (Fig.8).

Visually inspect the syringe for air bubbles. If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger up to eject only the air bubbles back into the vial. Recheck that 1 ml of the solution remains in the syringe. Carefully turn the vial containing the SOMAVERT reconstituted solution, adapter and syringe assembly and place them upright on a clean surface. Do not remove the syringe from the adapter at this point.

12. Open the needle packaging so that only the end of the needle to be connected to the syringe is exposed. The needle should be partially left in its protective packaging. Lay the needle with its protective packaging on the tabletop. Disconnect the syringe from the vial. Discard the protective packaging and attach the needle to the syringe. Keep the plastic cap on the needle while preparing the site for injection (Fig. 9). Once reconstituted, SOMAVERT should be used immediately. Please proceed to “STEP 2. GIVING THE INJECTION” b) NON VIAL ADAPTER METHOD

Getting Started

Wash your hands thoroughly. Collect one vial of powder (SOMAVERT) and one vial of solvent (Water for Injections), one 3-ml syringe with a 21-gauge, 1-inch detachable needle, one standard 1 ml insulin syringe, alcohol or antiseptic swabs and a proper disposal container for used needles. Inspect the expiry dates on both the vial label and the syringe label. They should not be used after the month and year shown.

After reconstitution with 1 ml of solvent, 1 ml of the clear solution contains either 10 mg, 15 mg, or 20 mg pegvisomant.

Preparing the SOMAVERT dose for injection

Remove the protective plastic caps from the tops of both vials. Take care not to touch the rubber vial stoppers. At this point, the stoppers are clean. If the stoppers are touched or otherwise contaminated, you must clean them with an antiseptic or alcohol swab before inserting a needle through the stopper.

Carefully remove the cap from the needle of the larger syringe (3 ml) and set the cap aside. This is the solvent syringe.

1. Pull the plunger of the solvent syringe down to the 1 ml mark. With one hand, securely hold the vial of solvent and, with the other hand, insert the needle of the solvent syringe straight through the center of the rubber stopper and deep into the vial. Gently push the plunger until the air is injected into the vial. (Fig. 1)

ADDING SOLVENT

2. Securely grasp the solvent vial and syringe assembly, with the needle still deeply inserted into the vial. Carefully turn the vial and syringe assembly upside down. Bring to eye level. (Fig. 2) 3. Slide one hand carefully down the solvent vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper part of the syringe. With the other hand, slowly pull the syringe plunger down to slightly past the 1 ml mark.

Examine the solution in the syringe for air bubbles. If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger up to eject only the air bubbles back into the vial. Recheck that 1 ml of solvent remains in the syringe, then withdraw the needle from the vial. (Fig 3)

4. Insert the needle of the solvent syringe straight through the stopper of the vial with the powder (SOMAVERT). Tilt the syringe to the side and gently inject the solvent down the inner side of the vial of SOMAVERT. When the solvent syringe is empty, withdraw it from the vial. Discard the solvent vial, syringe, and needle as directed by your healthcare provider. To minimise accidental injury, recap the needle only if instructed to do so by your healthcare provider, and in the manner demonstrated to you by your healthcare provider. (Fig 4) 5. Hold the vial of SOMAVERT upright between your hands and gently roll it to dissolve the powder. DO NOT SHAKE THE VIAL. The solution should be clear after the powder is dissolved. If the solution is cloudy or hazy, do not inject it. Notify your pharmacy and request a replacement vial. Do not throw the vial away because the pharmacy may request that you return it. Inject SOMAVERT immediately. (Fig. 5)

PREPARING THE INJECTION

6. Clean the rubber stopper of the vial of SOMAVERT with an antiseptic or alcohol swab. Remove the cap from the syringe (1 ml). Pull the syringe plunger down to the 1-ml mark. With one hand, securely hold the vial. With the other hand, insert the needle straight through the center of the rubber stopper and deep into the vial. Gently push the plunger until the air is injected into the vial. Securely grasp the vial and syringe assembly, with the needle still deeply inserted into the vial. Carefully turn the vial and syringe assembly upside down. Bring to eye level. (Fig. 6) 7. As before, slide one hand carefully down the vial so that with your thumb and forefinger you can securely grasp the neck of the vial, and with your other fingers, the upper portion of the syringe. With the other hand, slowly pull the syringe plunger down to withdraw the full contents of the vial (1 ml). To keep the needle tip within the liquid, you may have to slowly back it out of the stopper as you draw out the liquid.

Visually inspect the syringe for air bubbles. If bubbles are present, tap the syringe barrel until the bubbles rise to the top of the syringe. Carefully push the plunger up to eject only the air bubbles back into the vial. Recheck that 1 ml of the solution remains in the syringe, then withdraw the needle from the vial.

Recap the needle as directed by your health care provider to minimise accidental injury while preparing the site for injection. (Fig. 7)

GIVING THE INJECTION

Choose an injection site on the upper arm, upper thigh, abdomen or buttocks. Always move on to a different area with each day’s injection. It may be helpful to keep a record of each day’s injection site as you take your daily dose of SOMAVERT. Do not use an area that has a rash or broken skin, or is bruised or lumpy.

Clean the site with an antiseptic or alcohol swab, let the skin dry before injecting the product. Uncap the needle if previously recapped.

8. With one hand, gently pinch up the skin at the site of injection. Hold the syringe with the other hand, and in a single, smooth motion, push the needle completely into the skin straight down (at a 90-degree angle). (Fig. A) 9. Be sure to keep the needle all the way into the skin while you slowly push the syringe plunger down until the barrel is empty.

Release the pinched skin and pull the needle straight out. (Fig. B)

10. Do not rub the injection area. A small amount of bleeding may occur. If necessary, apply a clean, dry cotton swab over the area and press gently for 1 or 2 minutes, or until the bleeding has stopped. (Fig. C) Disposing of Supplies

The syringe and needle should NEVER be reused. Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.

All questions should be handled by a doctor, nurse or pharmacist familiar with SOMAVERT.


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Ivomec Plus



Dosage Form: FOR ANIMAL USE ONLY
ivomec®Plus
(1% w/v ivermectin and
10% w/v clorsulon in a sterile solution)
Injection for Cattle

NADA 140-833, Approved by the FDA       67302, 67303, 67304, 67305

For the effective treatment and control of internal parasites, including adult liver flukes, and external parasites.

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

INTRODUCTION

The ability of IVOMEC® (ivermectin) to deliver internal and external parasite control has been proven in cattle markets around the world. Now, Merial Limited combines ivermectin, the active ingredient of IVOMEC, with clorsulon, an effective adult flukicide. A single injection of Ivomec Plus (ivermectin and clorsulon) offers all the benefits of Ivomec Plus control of adult Fasciola hepatica.

The dosage level of clorsulon supplied by Ivomec Plus is effective only against adult liver flukes (Fasciola hepatica).

PRODUCT DESCRIPTION

Ivomec Plus is a ready-to-use sterile solution containing 1% w/v ivermectin, 10% clorsulon, 40% glycerol formal, and propylene glycol, q.s. ad 100%. It is formulated to deliver the recommended dose level of 200 mcg ivermectin/kg and 2 mg clorsulon/kg given subcutaneously behind the shoulder at the rate of 1 mL per 110 lb (50 kg) body weight.

MODE OF ACTION

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier. Clorsulon is rapidly absorbed into the circulating blood. Erythrocytes with bound drug as well as plasma are ingested by Fasciola hepatica. Adult Fasciola hepatica are killed by clorsulon because of inhibition of enzymes in the glycolytic pathway, which is their primary source of energy.

INDICATIONS

Ivomec Plus Injection is indicated for the effective treatment and control of the following parasites of cattle:

Gastrointestinal Roundworms (adults and fourth-stage larvae):
Ostertagia ostertagi (including inhibited O. ostertagi)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Bunostomum phlebotomum
Nematodirus helvetianus (adults only)
N. spathiger (adults only)
Oesophagostomum radiatum
Lungworms (adults and fourth-stage larvae):
Dictyocaulus viviparus
Liver Flukes:
Fasciola hepatica (adults only)
Cattle Grubs (parasitic stages):
Hypoderma bovis
H. lineatum
Sucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mange Mites (cattle scab1):
Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovis

1 Ivermectin has been approved as a scabicide by USDA/APHIS. Federal regulations require that cattle infested with or exposed to scabies (i.e., infestations with Psoroptes ovis) be treated. Ivermectin when used according to label instructions meets this requirement. Treated cattle may be shipped interstate, but they must not be mixed with other cattle for 14 days following treatment. The federal regulations make no restriction on the movement of cattle not affected with or exposed to scabies. However, individual states have additional regulations to govern the interstate shipment of cattle and the regulatory veterinarian in the state of destination should be consulted for applicable regulations on the use of ivermectin in the control of scabies. Persistent Activity

Ivomec Plus Injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei, and Cooperia oncophora for 14 days after treatment.

DOSAGE

Ivomec Plus should be given only by subcutaneous injection at a dose volume of 1 mL per 110 lb (50 kg) body weight. This volume will deliver 10 mg ivermectin and 100 mg clorsulon. For example:

Body Weight
(lb) Dose
(mL) 220 2 330 3 440 4 550 5 660 6 770 7 880 8 990 9 1100 10 ADMINISTRATION

Ivomec Plus (ivermectin and clorsulon) Injection is to be given subcutaneously only. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16-gauge, 1/2" to 3/4" sterile needle is recommended. Inject the solution subcutaneously (under the skin) behind the shoulder (see illustration).

Any single-dose syringe or standard automatic syringe equipment may be used with the 50 mL pack size. When using the 200 mL, 500 mL or 1000 mL pack size, use only automatic syringe equipment.

Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections.

No special handling or protective clothing is necessary.

The viscosity of the product increases in cool temperatures.

Administering IVOMEC® Plus at temperatures of 5°C (41°F) or below may be difficult. Users can make dosing easier by warming both the product and injection equipment to about 15°C (59°F).

ANIMAL SAFETY

In breeding animals (bulls and cows), ivermectin and clorsulon used at the recommended level had no effect on breeding performance.

Warning

NOT FOR USE IN HUMANS.
Keep this and all drugs out of the reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact Merial at 1-888-637-4251.

RESIDUE WARNING

Do not treat cattle within 49 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Precautions

Transitory discomfort has been observed in some cattle following subcutaneous administration. Soft-tissue swelling at the injection site has also been observed. These reactions have disappeared without treatment. Divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction. Different injection sites should be used for other parenteral products.

Ivomec Plus Injection has been developed specifically for use in cattle only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

For subcutaneous injection in cattle only.

This product is not for intravenous or intramuscular use.

Restricted Drug (California) - use only as directed.

When to Treat Cattle with Grubs

Ivomec Plus effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season.

Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities. Killing Hypoderma lineatum when it is in the tissue surrounding the esophagus (gullet) may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. These reactions are not specific to treatment with Ivomec Plus, but can occur with any successful treatment of grubs. Cattle should be treated either before or after stages of grub development. Consult your veterinarian concerning the proper time for treatment.

Cattle treated with Ivomec Plus after the end of the heel fly season may be retreated with ivermectin during the winter for internal parasites, mange mites or sucking lice, without danger of grub-related reactions. A planned parasite control program is recommended.

Protect product from light.

Environmental Safety

Studies indicate that when ivermectin comes in contact with soil it readily and tightly binds to the soil and becomes inactive overtime. Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit water runoff from feedlots to enter lakes, streams or ponds. Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific.

When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

How is Ivomec Plus Supplied

Ivomec Plus Injection is available in four ready-to-use pack sizes:

The 50 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 10 head of 550 lb (250 kg) cattle.

The 200 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 40 head of 550 lb (250 kg) cattle.

The 500 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle.

The 1000 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle.

IVOMEC and Cattle Head Logo are registered trademarks of Merial Limited.

Copyright © 2010 Merial Limited. All Rights Reserved.

Distributed by:
Merial Limited
Duluth, GA 30096 USA

Made in Brazil

Rev. 08/2010

PRINCIPAL DISPLAY PANEL - 1000 mL Carton

NADA 140-833, Approved by the FDA
Product 67305

ivomec®Plus

(1% w/v ivermectin and
10% w/v clorsulon in a sterile solution)

Injection for Cattle

Treats 200–550 lb Cattle

For the treatment and control of internal
parasites, including adult liver flukes, and
external parasites.

1000 mL
MERIAL


Ivomec Plus 
ivermectin and clorsulon  injection Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50604-4747 Route of Administration SUBCUTANEOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 10 mg  in 1 mL clorsulon (clorsulon) clorsulon 100 mg  in 1 mL Inactive Ingredients Ingredient Name Strength glycerol formal   Propylene Glycol   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 50604-4747-1 1 BOTTLE In 1 CARTON contains a BOTTLE 1 50 mL In 1 BOTTLE This package is contained within the CARTON (50604-4747-1) 2 50604-4747-2 1 BOTTLE In 1 CARTON contains a BOTTLE 2 200 mL In 1 BOTTLE This package is contained within the CARTON (50604-4747-2) 3 50604-4747-3 1 BOTTLE In 1 CARTON contains a BOTTLE 3 500 mL In 1 BOTTLE This package is contained within the CARTON (50604-4747-3) 4 50604-4747-4 1 BOTTLE In 1 CARTON contains a BOTTLE 4 1000 mL In 1 BOTTLE This package is contained within the CARTON (50604-4747-4)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140833 10/01/1990
Labeler - Merial Limited (034393582) Revised: 09/2010Merial Limited

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Adrenogenital Syndrome Medications


Definition of Adrenogenital Syndrome: Congenital adrenal hyperplasia refers to a group of inherited disorders relating to the adrenal glands, characterized by a deficiency in the hormones cortisol and aldosterone and an overproduction of androgen. More...

Drugs associated with Adrenogenital Syndrome

The following drugs and medications are in some way related to, or used in the treatment of Adrenogenital Syndrome. 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 Adrenogenital Syndrome

Medical Encyclopedia:

Congenital adrenal hyperplasia
Drug List: A-Methapred-Solution Baycadron De-Sone-La-Injection Decadron Deltasone Depo-Medrol-Suspension Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Florinef Florinef-Acetate Medrol Medrol-Dosepak Methylprednisolone-Dose-Pack Meticorten Solu-Medrol-Solution Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Zema-Pak-10-Day
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Monistat 1 Combo Pack Cream


Pronunciation: mi-KON-a-zole
Generic Name: Miconazole
Brand Name: Monistat 1 Combo Pack
Monistat 1 Combo Pack Cream is used for:

Treating vaginal yeast infections and relieving external vulvar itching and irritation associated with yeast infection.

Monistat 1 Combo Pack Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Monistat 1 Combo Pack Cream if: you are allergic to any ingredient in Monistat 1 Combo Pack Cream you have never had a vaginal yeast infection diagnosed by a doctor

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

Before using Monistat 1 Combo Pack Cream:

Some medical conditions may interact with Monistat 1 Combo Pack Cream. 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 the blood disease porphyria or a history of liver disease, or you have been exposed to HIV if you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, once a month or 3 in 6 months) if you are taking antibiotics

Some MEDICINES MAY INTERACT with Monistat 1 Combo Pack Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of side effects such as bruising or bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Monistat 1 Combo Pack Cream 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 Monistat 1 Combo Pack Cream:

Use Monistat 1 Combo Pack Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Monistat 1 Combo Pack Cream comes with an additional patient leaflet. Read it carefully and reread it each time you get Monistat 1 Combo Pack Cream refilled. Monistat 1 Combo Pack Cream is for vaginal use only. Do not use in the eyes or take by mouth. Suppositories - Using the applicator provided, insert the suppository high into the vagina at bedtime. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Monistat 1 Combo Pack Cream. To clear up your infection completely, continue using Monistat 1 Combo Pack Cream for the full course of treatment. If you miss a dose of Monistat 1 Combo Pack Cream, use it as soon as possible. If it is almost time for your next dose, 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 Monistat 1 Combo Pack Cream.

Important safety information: Monistat 1 Combo Pack Cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Monistat 1 Combo Pack Cream in your eyes, flush with a generous amount of cool water. It is important to use Monistat 1 Combo Pack Cream for the full course of treatment. Failure to do so may decrease the effectiveness of Monistat 1 Combo Pack Cream and increase the risk that the fungus will no longer be sensitive to Monistat 1 Combo Pack Cream and will not be able to be treated by this or certain other antibiotics in the future. If your symptoms do not improve within 3 days, if they last more than 7 days, or if they become worse, stop using Monistat 1 Combo Pack Cream and contact your health care provider at once. You may have a more serious illness. Do not use Monistat 1 Combo Pack Cream for itching caused by other conditions. Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Monistat 1 Combo Pack Cream. Change out of wet bathing suits or damp workout clothes as soon as possible. Continue using Monistat 1 Combo Pack Cream even during your menstrual period. Do not use tampons while you are using Monistat 1 Combo Pack Cream or until all of your symptoms go away. Use unscented pads or pantiliners. Do not have vaginal sexual intercourse while you are using Monistat 1 Combo Pack Cream. Monistat 1 Combo Pack Cream may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use these products for at least 1 day after treatment with Monistat 1 Combo Pack Cream. Do not use tampons, douches, spermicides, or other vaginal products while using Monistat 1 Combo Pack Cream. Overuse of topical products may worsen your condition. Do not use Monistat 1 Combo Pack Cream in CHILDREN younger than 12 years of age unless advised to do so by your health care provider. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Monistat 1 Combo Pack Cream, discuss with your doctor the benefits and risks of using Monistat 1 Combo Pack Cream during pregnancy. It is unknown if Monistat 1 Combo Pack Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Monistat 1 Combo Pack Cream, check with your doctor or pharmacist. Possible side effects of Monistat 1 Combo Pack Cream:

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:

Headache; mild vaginal burning, irritation, or itching; stomach cramps.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever or chills; foul-smelling vaginal discharge; nausea; severe or prolonged vaginal burning, irritation, or itching; stomach pain; swelling; vomiting.

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: Monistat Combo Pack 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.

Proper storage of Monistat 1 Combo Pack Cream:

Store Monistat 1 Combo Pack Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Monistat 1 Combo Pack Cream out of the reach of children and away from pets.

General information: If you have any questions about Monistat 1 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Monistat 1 Combo Pack Cream 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 Monistat 1 Combo Pack Cream. 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 Monistat 1 Combo Pack resources Monistat 1 Combo Pack Side Effects (in more detail) Monistat 1 Combo Pack Use in Pregnancy & Breastfeeding Monistat 1 Combo Pack Drug Interactions 0 Reviews for Monistat Combo Pack - Add your own review/rating Compare Monistat 1 Combo Pack with other medications Vaginal Yeast Infection
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Rhophylac 300 (1500 IU)


CSL Behring

Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe

Active substance: Human anti-D immunoglobulin

Please read all of this leaflet carefully before you are given this medicine Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or healthcare professional. 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 healthcare professional. In this leaflet:

1. What Rhophylac is and what it is used for
2. Before you are given Rhophylac
3. How Rhophylac will be administered
4. Possible side effects
5. How to store Rhophylac
6. Further information

What Rhophylac Is And What It Is Used For What is Rhophylac?

Rhophylac is a ready-to-use solution for injection, which comes in a pre-filled syringe. The solution contains special proteins, isolated from human blood plasma. These proteins belong to the class of so called "immunoglobulins", also called antibodies. The active ingredient of Rhophylac is a specific antibody called "anti-D (Rh) immunoglobulin". This antibody works against Rhesus factor type D.

What is Rhesus factor type D?

Rhesus factors are special characteristics of human red blood cells. About 85% of the population carry the so called Rhesus factor type D (abbreviated "Rh(D)"). These people are called Rh(D)-positive. People who do not carry Rhesus factor type D are called Rh(D)-negative.

What is anti-D (Rh) immunoglobulin?

Anti-D (Rh) immunoglobulin is an antibody, which works against Rhesus factor type D and is produced by the human immune system. When a Rh(D)-negative person receives Rh(D)-positive blood, her/his immune system will recognise the Rh(D)-positive red blood cells as "foreign" to her/his body, and will attempt to destroy them. For this purpose, the immune system will build specific antibodies against Rhesus factor type D. This process is called "immunisation" and it usually takes some time (2–3 weeks). Therefore, the Rh(D)-positive red blood cells will not be destroyed upon the first contact, and no signs or symptoms are usually seen then. But when the same Rh(D)-negative person receives Rh(D)-positive blood a second time, the antibodies will be "ready at hand" and her/his immune system will destroy the foreign red blood cells immediately.

How Rhophylac works

If a Rh(D)-negative person is given a sufficient amount of human anti-D (Rh) immunoglobulin, immunisation against Rhesus factor type D can be prevented. To achieve this, treatment with Rhophylac should commence before or early enough after the first contact to Rh(D)-positive red blood cells. The anti-D (Rh) immunoglobulins contained in Rhophylac will then destroy the foreign Rh(D)-positive red blood cells immediately. Thus, the person's immune system will not be prompted to build-up its own antibodies.

What Rhophylac is used for

Rhophylac is used in two distinct situations:

A) You are a Rh(D)-negative pregnant woman, who carries a Rh(D)-positive baby
In this special situation you may be immunised by red blood cells from your baby passing over into your own blood circulation. If this happens, the first baby is not usually affected and fully healthy. But in the next Rh(D)-positive baby, the mother's antibodies would destroy the baby's red blood cells already during pregnancy. This may lead to serious complications with the baby, including his/her possible death.

As a Rh(D)-negative pregnant woman, you may receive anti-D (Rh) immunoglobulins in the following situations:

when you carry or have just delivered a Rh(D)-positive baby; when you lose a Rh(D)-positive baby (miscarriage, threatened miscarriage or abortion); when your pregnancy is severely complicated (ectopic pregnancy or hydatidiform mole); when it is likely that your baby's red blood cells have passed over into your own blood circulation (transplacental haemorrhage resulting from antepartum haemorrhage). This may, for example, happen when you experience vaginal bleedings during pregnancy; when your doctor needs to perform testing methods for foetal deformities (amniocentesis, chorionic biopsy); when your doctor or midwife needs to try moving the baby from outside (e.g., external version of the baby or other obstetric manipulative procedures); when you have an accident hurting your stomach or gut (abdominal trauma).

B) You are a Rh(D)-negative person, who has accidentally received infusions (transfusions) of Rh(D)-positive blood (mismatched transfusion). This also applies to any blood products containing Rh(D)-positive red blood cells.

Before You Are Given Rhophylac You should not receive Rhophylac If you are hypersensitive (allergic) to human immunoglobulins, to human albumin or to any of the other ingredients of Rhophylac (please see section 6 of this leaflet for a full statement of all ingredients). Please tell your doctor or healthcare professional prior to treatment about any medicine or food which you have not well tolerated earlier. You must not receive injections into a muscle, if you suffer from a severe reduction in the number of platelets (thrombocytopenia), any other severe blood clotting disorder. Please tell your doctor or healthcare professional prior to treatment if this applies to you. In this case Rhophylac may be given to you only by injection into a vein. Special care should be taken with Rhophylac For protecting Rh(D)-negative women after delivery of a Rh(D)-positive baby, Rhophylac is always given to the mother, not to the newborn baby. Rhophylac is not intended for use in Rh(D)-positive persons. Rhophylac may trigger hypersensitivity reactions (allergic responses).
Early signs of hypersensitivity reactions may appear as small itching bubbles on your skin (hives) or all over your body (generalised urticaria), tightness of the chest, wheezing, fall in blood pressure (hypotension) or a shock-like state (anaphylaxis). Please keep those signs in mind, and if such symptoms occur, please tell your doctor or healthcare professional immediately. They will then stop the administration of the product and treat you depending on the nature and severity of the side effect. Rhophylac may also contain human immunoglobulins (antibodies) of the IgA type.
Persons who have low levels of the IgA type immunoglobulins are thus more likely to experience a hypersensitivity reaction. Should you have low levels of the IgA type immunoglobulins, please tell your doctor or healthcare professional. Your doctor will then very thoroughly weigh the benefit of treatment with Rhophylac against the increased risk of hypersensitivity reactions. For your safety, your doctor or healthcare professional will observe you for at least 20 minutes after receiving Rhophylac.

Information on safety with respect to infections

Rhophylac is made from human blood plasma (this is the liquid part of the blood).

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include

careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,

and

the testing of each donation and pools of plasma for signs of virus/infections.

Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses and other types of infections.

The measures taken for Rhophylac are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus.

The measures may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.

Immunoglobulins like Rhophylac have not been associated with hepatitis A or parvovirus B19 infections. This is possibly because antibodies against these infections are also present in immunoglobulins. These antibodies may help preventing hepatitis A or parvovirus B19 infections.

It is strongly recommended that every time you receive a dose of Rhophylac the name and batch number of the product are recorded in order to maintain a record of the batches used.

Taking other medicines Always tell your doctor or healthcare professional if you are taking or have recently taken any other medicines. This also applies to medicines obtained without a prescription.

Interactions of Rhophylac with other treatments have not been investigated in clinical studies. The information given in this section is derived from the literature and from current guidelines.

Vaccinations

Rhophylac may impair the efficacy of vaccinations with live virus vaccines, for example against measles, mumps, rubella (German measles) or varicella (chicken pox).

Such vaccinations should therefore not be given until 3 months after you were last given Rhophylac. Please inform your vaccinating doctor about your treatment with Rhophylac. If you have just had a vaccination within the last 2–4 weeks Please tell your doctor or healthcare professional prior to treatment. Please also inform your vaccinating doctor after the treatment. He can then plan to check the efficacy of your vaccination.

Laboratory tests

After you were given Rhophylac, the results of some blood tests (serological testing) may be altered for a certain period of time. If you are a mother having received Rhophylac before delivery, the results of some blood tests in your newborn baby may also be affected.

Should you or your newborn baby have such blood tests, please inform your doctor or healthcare professional that you were treated with Rhophylac. Pregnancy and breast-feeding

This medicinal product is used in pregnancy or early after delivery. In clinical studies with 432 mothers who received Rhophylac before delivery, no side effects were seen in their children.

Driving and operating machines:

No effects of Rhophylac on the ability to drive and use machines are expected.

How To Use Rhophylac Rhophylac will be injected by your doctor or healthcare professional into a muscle or directly into a vein. Your doctor will decide how much Rhophylac you should receive and which is the appropriate route of administration. The syringe should be brought to room or body temperature before use. One syringe should be used for one patient only (even if product is left over then).

Please note the early signs of hypersensitivity reactions given in section 2 of this leaflet. If such symptoms occur, please tell your doctor or healthcare professional immediately.

If you receive more Rhophylac than the usual dose

No data are available on overdosage.

If you are treated with Rhophylac after a mismatched transfusion, you may receive quite a large amount of the product (up to 3,000 micrograms, equivalent to 20 ml or 10 syringes). In this case there is an increased risk for a special complication called haemolytic reaction. This results from the intended destruction of the foreign Rh(D)-positive red blood cells. For this reason your doctor or healthcare person will monitor you closely and may need to do special blood tests.

In other Rh(D)-negative people more frequent or more severe side effects are not expected, even after large amounts of Rhophylac ("overdosage").

Possible Side Effects

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

If you are given Rhophylac into a muscle, you may feel local pain and tenderness at the injection site.

The following side effects may occur occasionally (between 1 in 100 and 1 in 1,000 persons treated):

fever and chills (shivering), generally feeling unwell (malaise), headache, skin reactions.

The following side effects may occur rarely (between 1 in 1,000 and 1 in 10,000 persons treated):

nausea and/or vomiting, low blood pressure (hypotension), rapid heartbeat or pulse rate (tachycardia), hypersensitivity reactions (allergic or anaphylactic type), including difficulty in breathing (dyspnoea) and shock.
Please note the early signs of hypersensitivity reactions given in section 2 of this leaflet. If such symptoms occur, please tell your doctor or health care professional immediately.

Such side effects may occur even when you have previously received human immunoglobulins and had tolerated them well.

Please tell your doctor or healthcare professional if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet. How To Store Rhophylac Keep out of the reach and sight of children. Store in a refrigerator (+2 to +8 °C). Do not freeze. Keep the syringe in the outer carton (in its sealed plastic pack) in order to protect from light.

Do not use Rhophylac after the expiry date. It is stated on the outer carton and the syringe label in the format MM.YYYY (M = month, Y = year). The expiry date refers to the last day of that month.

Do not use Rhophylac if you notice that the solution is cloudy or has deposits.

Further Information What Rhophylac contains The active substance is human anti-D (Rh) immunoglobulin (antibodies of the IgG type against the so called Rhesus factor type D). The other ingredients are human albumin, glycine and sodium chloride. This product contains a maximum of 30 mg/ml of human plasma proteins of which 10 mg/ml is human albumin as stabiliser. At least 95% of the other plasma proteins are human immunoglobulins (antibodies) of the IgG type. Rhophylac contains not more than 5 micrograms/ml human immunoglobulins (antibodies) of the IgA type. What Rhophylac looks like and contents of the pack

Rhophylac 300 is a clear or slightly pearly solution for injection. It comes in a glass syringe prefilled with 2 ml of solution containing 1,500 IU (300 micrograms) of anti-D immunoglobulin.

The pack contains 1 pre-filled syringe and 1 injection needle, both packed in one blister pack (a clear plastic container sealed with a paper foil).

Marketing Authorisation Holder and Manufacturer CSL Behring GmbH Emil-von-Behring-Strasse 76 35041, Marburg Germany

This leaflet was last approved in: 06/2010


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Mycelex-7 Combo Pack Cream


Pronunciation: kloe-TRIM-a-zole
Generic Name: Clotrimazole
Brand Name: Mycelex-7 Combo Pack
Mycelex-7 Combo Pack Cream is used for:

Treating vaginal yeast infections and relieving external vulvar itching and irritation associated with yeast infection.

Mycelex-7 Combo Pack Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Mycelex-7 Combo Pack Cream if: you are allergic to any ingredient in Mycelex-7 Combo Pack Cream you have never had a vaginal yeast infection diagnosed by a doctor you have itching caused by a condition other than a yeast infection you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting

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

Before using Mycelex-7 Combo Pack Cream:

Some medical conditions may interact with Mycelex-7 Combo Pack Cream. 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 the blood disease porphyria or a history of liver disease or diabetes, or you have been exposed to HIV if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, your symptoms return within 2 months) or your symptoms do not clear up with treatment if you are taking antibiotics

Some MEDICINES MAY INTERACT with Mycelex-7 Combo Pack Cream. However, no specific interactions with Mycelex-7 Combo Pack Cream are known at this time.

Ask your health care provider if Mycelex-7 Combo Pack Cream 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 Mycelex-7 Combo Pack Cream:

Use Mycelex-7 Combo Pack Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Mycelex-7 Combo Pack Cream. Talk to your pharmacist if you have questions about this information. Mycelex-7 Combo Pack Cream is for vaginal use only. Do not use it rectally or take by mouth. Suppositories - Using the applicator provided, insert 1 suppository high into the vagina at bedtime for 7 days. Mycelex-7 Combo Pack Cream comes with one applicator to be used for all 7 days of treatment. Do not throw away applicator after use. Separate the pieces of the applicator and wash with warm, soapy water immediately after use. Rinse thoroughly. Make sure the applicator is completely dry before the next use. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Mycelex-7 Combo Pack Cream. To clear up your infection completely, use Mycelex-7 Combo Pack Cream for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Mycelex-7 Combo Pack Cream, use it as soon as possible. If it is almost time for your next dose, 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 Mycelex-7 Combo Pack Cream.

Important safety information: Mycelex-7 Combo Pack Cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Mycelex-7 Combo Pack Cream in your eyes, flush with a generous amount of cool water. Be sure to use Mycelex-7 Combo Pack Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. If your symptoms do not improve within 3 days, if they last more than 7 days, or if they get worse, check with your doctor. Do not use Mycelex-7 Combo Pack Cream for itching caused by other conditions. Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Mycelex-7 Combo Pack Cream. Change out of wet bathing suits or damp workout clothes as soon as possible. Continue using Mycelex-7 Combo Pack Cream even during your menstrual period. Do not use tampons while you are using Mycelex-7 Combo Pack Cream or until all of your symptoms go away. Use unscented pads or pantiliners. Do not have vaginal sexual intercourse while you are using Mycelex-7 Combo Pack Cream. Mycelex-7 Combo Pack Cream may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use tampons, douches, spermicides, or other vaginal products while using Mycelex-7 Combo Pack Cream. If you use topical products too often, your condition may become worse. Mycelex-7 Combo Pack Cream should not be used in CHILDREN younger than 12 years old; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mycelex-7 Combo Pack Cream while you are pregnant. It is not known if Mycelex-7 Combo Pack Cream is found in breast milk. If you are or will be breast-feeding while you use Mycelex-7 Combo Pack Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Mycelex-7 Combo Pack Cream:

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:

Headache; mild vaginal burning, irritation, or itching; stomach cramps.

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); fever or chills; foul-smelling vaginal discharge; nausea; severe or prolonged vaginal burning, irritation, or itching; stomach pain; swelling; vomiting.

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: Mycelex-7 Combo Pack 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.

Proper storage of Mycelex-7 Combo Pack Cream:

Store Mycelex-7 Combo Pack Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Avoid temperatures above 86 degrees F (30 degrees C). Avoid freezing. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Mycelex-7 Combo Pack Cream out of the reach of children and away from pets.

General information: If you have any questions about Mycelex-7 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Mycelex-7 Combo Pack Cream 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 Mycelex-7 Combo Pack Cream. 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 Mycelex-7 Combo Pack resources Mycelex-7 Combo Pack Side Effects (in more detail) Mycelex-7 Combo Pack Use in Pregnancy & Breastfeeding Mycelex-7 Combo Pack Support Group 0 Reviews for Mycelex-7 Combo Pack - Add your own review/rating Compare Mycelex-7 Combo Pack with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Influenza vaccine (split virion, inactivated) Ph. Eur.


1. Name Of The Medicinal Product

Influenza vaccine (split virion, inactivated), pre-filled syringe

2. Qualitative And Quantitative Composition

Split influenza virus* (inactivated with ?-Propiolactone) of the following strains:

A/California/7/2009 (H1N1)-like strain (A/California/7/2009 NYMC X-181)

15 micrograms HA**

A/Perth/16/2009 (H3N2)-like strain (A/Victoria/210/2009/NYMC X-187)

15 micrograms HA**

B/Brisbane/60/2008-like strain (B/Brisbane/60/2008)

15 micrograms HA**

per 0.5 ml dose.

* propagated in fertilised hens' eggs from healthy chicken flocks

** haemagglutinin

This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2010/2011 season.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Suspension for injection in a pre-filled syringe.

Clear to slightly opaque liquid with some sediment that resuspends upon shaking.

4. Clinical Particulars 4.1 Therapeutic Indications

Prophylaxis of influenza, especially in those who run an increased risk of associated complications.

The use of Influenza vaccine (split virion, inactivated) should be based on official recommendations.

4.2 Posology And Method Of Administration

Posology

Adults and children from 5 years:

0.5 ml

For children aged less than 9 years, who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Method of administration

Immunisation should be carried out by intramuscular or deep subcutaneous injection.

For instructions for preparation, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients (see section 6.1), to eggs, ovalbumin or chicken proteins.

The vaccine may contain residues of the following substances: neomycin, polymyxin.

Immunisation shall be postponed in patients with febrile illness or acute infection.

4.4 Special Warnings And Precautions For Use

During the 2010 Southern Hemisphere influenza season, there was an unexpected increase in reports of fever and febrile convulsions in children aged less than 5 years following seasonal influenza vaccination with the flu vaccine of the same strain composition as contained in this product. Febrile convulsions were reported uncommonly (i.e. reporting frequency estimated to be in the range However, the vaccine is recommended for use in children only from 5 years of age.

(*estimated from epidemiological investigations).

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine.

Influenza vaccine (split virion, inactivated) should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Influenza vaccine (split virion, inactivated) may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

Following influenza vaccination, false positive results in serological tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the IgM response to the vaccine.

4.6 Pregnancy And Lactation

Pregnancy

The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

Lactation

Influenza vaccine (split virion, inactivated) may be used during lactation.

4.7 Effects On Ability To Drive And Use Machines

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

4.8 Undesirable Effects

Adverse reactions observed from clinical trials

The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirements, including at least 50 adults aged 18 – 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first three days following vaccination.

The following undesirable effects have been observed during clinical trials with the following frequencies: Very common (>1/10), common (

Organ class

Very common

> 1/10

Common

Uncommon

Rare

Very rare

< 1/10,000

Nervous system disorders

 

Headache*

     

Skin and subcutaneous tissue disorders

 

Sweating*

     

Musculoskeletal and connective tissue disorders

 

Myalgia, arthralgia*

     

General disorders and administration site conditions

 

Fever, malaise, shivering, fatigue.

Local reactions: redness, swelling, pain, ecchymosis, induration*

     

* These reactions usually disappear within 1-2 days without treatment

Adverse reactions reported from post-marketing surveillance

Adverse reactions reported from post marketing surveillance are, in addition to the reactions which have also been observed during the clinical trials, the following:

Blood and lymphatic system disorders

Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders

Allergic reactions, in rare cases leading to anaphylactic shock, angioedema

Nervous system disorders

Neuralgia, paraesthesia, convulsions (including febrile convulsions)

Neurological disorders, such as encephalomyelitis, neuritis and Guillain-Barr? syndrome

Vascular disorders

Vasculitis associated in very rare cases with transient renal involvement

Skin and subcutaneous tissue disorders

Generalised skin reactions including pruritus, urticaria or non-specific rash

4.9 Overdose

Overdosage is unlikely to have any untoward effects.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07B B02

Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6 to 12 months.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium chloride

Anhydrous disodium phosphate

Sodium dihydrogen phosphate dihydrate

Potassium chloride

Potassium dihydrogen phosphate

Calcium chloride

Water for injection

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

15 months.

6.4 Special Precautions For Storage

Store in a refrigerator (2°C to 8°C). Do not freeze.

Keep the syringe in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

0.5 ml suspension in pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) with or without attached needle in pack sizes of 1 or 10, respectively.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The vaccine should be allowed to reach room temperature before use. Shake before use. After shaking, the vaccine should appear as a homogenous suspension. The vaccine must be inspected visually prior to administration and should not be used if there is any variation of physical appearance (see section 3).

Influenza vaccine (split virion, inactivated) is presented as a single use syringe and any remaining contents should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

CSL Biotherapies GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

8. Marketing Authorisation Number(S)

PL 22236/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

19 April 2005 / 29 March 2009

10. Date Of Revision Of The Text

03 August 2010


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Vetrimec Plus



Dosage Form: FOR ANIMAL USE ONLY
VETone™
Vetrimec™ PLUS
(Ivermectin-Clorsulon)

Injection for Cattle

1% w/v ivermectin and 10% w/v clorsulon in a sterile solution

ANADA 200-436         Approved by the FDA

For the effective treatment and control of internal parasites, including adult liver flukes, and external parasites. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

INTRODUCTION

The ability of ivermectin to deliver internal and external parasite control has been proven in cattle markets around the world. Now, Vetrimec™ Plus combines ivermectin with clorsulon, an effective adult flukicide.

A single injection of Vetrimec™ Plus (ivermectin and clorsulon) offers all the benefits of an ivermectin injection plus control of adult Fasciola hepatica.

The dosage level of clorsulon supplied by Vetrimec™Plus is effective only against adult liver flukes (Fasciola hepatica).

PRODUCT DESCRIPTION

Vetrimec™ Plus is a ready-to-use sterile solution containing 1% w/v ivermectin, 10% clorsulon, 40% glycerol formal, and propylene glycol, q.s. ad 100%. It is formulated to deliver the recommended dose level of 200 mcg ivermectin/kg and 2 mg clorsulon/kg given subcutaneously behind the shoulder at the rate of 1 mL per 110 lb (50 kg) body weight.

MODE OF ACTION

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

Clorsulon is rapidly absorbed into the circulating blood. Erythrocytes with bound drug as well as plasma are ingested by Fasciola hepatica. Adult Fasciola hepatica are killed by clorsulon because of inhibition of enzymes in the glycolytic pathway, which is their primary source of energy.

INDICATIONS

Vetrimec™ Plus Injection is indicated for the effective treatment and control of the following parasites in cattle:

Gastrointestinal Roundworms (adults and fourth-stage larvae):

Ostertagia ostertagi (including inhibited O. ostertagi)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Bunostomum phlebotomum
Nematodirus helvetianus (adults only)
N. spathiger (adults only)
Oesophagostomum radiatum

Lungworms (adults and fourth-stage larvae):

Dictyocaulus viviparus

Liver Flukes:

Fasciola hepatica (adults only)

Cattle Grubs (parasitic stages):

Hypoderma bovis

H. lineatum

Sucking Lice:

Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus

Mange Mites (cattle scab*):

Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovis

Persistent Activity

Ivermectin and clorsulon injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei, and Cooperia oncophora for 14 days after treatment.

* Ivermectin has been approved as a scabicide by USDA/APHIS. Federal regulations require that cattle infested with or exposed to scabies (i.e., infestations with Psoroptes ovis) be treated. Ivermectin when used according to label instructions meets this requirement. Treated cattle may be shipped interstate, but they must not be mixed with other cattle for 14 days following treatment.

The federal regulations make no restriction on the movement of cattle not affected with or exposed to scabies. However, individual states have additional regulations to govern the interstate shipment of cattle and the regulatory veterinarian in the state of destination should be consulted for applicable regulations on the use of ivermectin in the control of scabies.

DOSAGE

Vetrimec™ Plus should be given only by subcutaneous injection at a dose volume of 1 mL per 110 lb (50 kg) body weight. This volume will deliver 10 mg ivermectin and 100 mg clorsulon. For example:

Body Weight (lb) Dose (mL) 220 2 330 3 440 4 550 5 660 6 770 7 880 8 990 9 1100 10 ADMINISTRATION

Vetrimec™ Plus (ivermectin and clorsulon) Injection is to be given subcutaneously only. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16-gauge,?" to ?" sterile needle is recommended. Inject the solution subcutaneously (under the skin) behind the shoulder (see illustration).

Any single-dose syringe or standard automatic syringe equipment may be used with the 50 mL or 100 mL pack size. When using the 250 mL, 500 mL or 1000 mL pack size, use only automatic syringe equipment.

Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections.

No special handling or protective clothing is necessary.

The viscosity of the product increases in cool temperatures. Administering Vetrimec™ Plus at temperatures of 5 °C (41 °F) or below may be difficult. Users can make dosing easier by warming both the product and injection equipment to about 15 °C (59 °F).

ANIMAL SAFETY

In breeding animals (bulls and cows), ivermectin and clorsulon used at the recommended level had no effect on breeding performance.

WARNING

NOT FOR USE IN HUMANS.

Keep this and all drugs out of the reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact MWI at 1-888-694-8381.

RESIDUE INFORMATION: Do not treat cattle within 49 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

PRECAUTIONS

Transitory discomfort has been observed in some cattle following subcutaneous administration. Soft-tissue swelling at the injection site has also been observed. These reactions have disappeared without treatment. Divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction. Different injection sites should be used for other parenteral products.

Vetrimec™ Plus Injection has been developed specifically for use in cattle only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

For subcutaneous injection in cattle only.

This product is not for intravenous or intramuscular use.

When to Treat Cattle with Grubs

Vetrimec™ Plus effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season.

Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities.

Killing Hypoderma lineatum when it is in the tissue surrounding the esophagus (gullet) may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. These reactions are not specific to treatment with Vetrimec™ Plus, but can occur with any successful treatment of grubs. Cattle should be treated either before or after these stages of grub development. Consult your veterinarian concerning the proper time for treatment.

Cattle treated with Vetrimec™ Plus after the end of the heel fly season may be retreated with ivermectin during the winter for internal parasites, mange mites, or sucking lice, without danger of grub-related reactions. A planned parasite control program is recommended.

STORAGE

Protect product from light.

Store at 15°- 30°C (59°- 86°F).

ENVIRONMENTAL SAFETY

Studies indicate that when ivermectin comes in contact with soil it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain aquatic organisms.

Do not permit water runoff from feedlots to enter lakes, streams, or ponds. Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

HOW SUPPLIED

Vetrimec™ Plus Injection is available in five ready-to-use pack sizes:

The 50 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 10 head of 550 lb (250 kg) cattle.

The 100 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 20 head of 550 lb (250 kg) cattle.

The 250 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 50 head of 550 lb (250 kg) cattle.

The 500 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle.

The 1000 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle.

Restricted Drug - California. Use Only as Directed.

Made in the UK.

Manufactured by:
Norbrook Laboratories Limited,

Newry, Co. Down, Northern Ireland.

Distributed by: MWI
Meridian, ID 83680
(888) 694-8381
www.vetone.net

VETone™

002684I03

Principal Display Panel – 1000 mL – Bottle Label

NDC 13985-038-06 1000mL

VETone™

Vetrimec™ PLUS

(Ivermectin-Clorsulon)

Injection for Cattle

1% w/v ivermectin and 10% w/v clorsulon in a sterile solution

FOR ANIMAL USE ONLY.

KEEP PUT OF REACH OF CHILDREN.

ANADA 200-436

Approved by the FDA

V1 504036

Net Contents: 1000 mL

Principal Display Panel – 1000 mL – Carton Label

NDC 13985-038-06 1000 mL

VETone™

Vetrimec™ PLUS

(Ivermectin-Clorsulon)

(Injection for Cattle)

1% w/v ivermectin and 10% w/v clorsulon in a sterile solution

Treat 200 – 550 lb Cattle

For the treatment and control of internal parasites, including adult liver flukes, and external parasites.

ANADA 200-436

Approved by the FDA

V1 504036 Net Contents: 1000 mL


Vetrimec Plus FOR CATTLE 
ivermectin and clorsulon  injection, solution Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 13985-038 Route of Administration SUBCUTANEOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 10 mg  in 1 mL clorsulon (clorsulon) clorsulon 100 mg  in 1 mL Inactive Ingredients Ingredient Name Strength propylene glycol   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 13985-038-01 1 VIAL In 1 CARTON contains a VIAL, PLASTIC 1 50 mL In 1 VIAL, PLASTIC This package is contained within the CARTON (13985-038-01) 2 13985-038-02 1 VIAL In 1 CARTON contains a VIAL, PLASTIC 2 100 mL In 1 VIAL, PLASTIC This package is contained within the CARTON (13985-038-02) 3 13985-038-04 1 VIAL In 1 CARTON contains a VIAL, PLASTIC 3 250 mL In 1 VIAL, PLASTIC This package is contained within the CARTON (13985-038-04) 4 13985-038-05 1 VIAL In 1 CARTON contains a VIAL, PLASTIC 4 500 mL In 1 VIAL, PLASTIC This package is contained within the CARTON (13985-038-05) 5 13985-038-06 1 VIAL In 1 CARTON contains a VIAL, PLASTIC 5 1000 mL In 1 VIAL, PLASTIC This package is contained within the CARTON (13985-038-06)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200436 04/20/2007
Labeler - MWI/VetOne (019926120) Registrant - Norbrook Laboratories Limited (214580029) Establishment Name Address ID/FEI Operations Armagh Road 232880554 MANUFACTURE, ANALYSIS Establishment Name Address ID/FEI Operations Carnbane Industrial Estate 211218325 MANUFACTURE Revised: 03/2010MWI/VetOne

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AVONEX 30 micrograms powder and solvent for solution for injection


AVONEX 30 micrograms powder and solvent for solution for injection

(Interferon beta-1a)

BIO-SET Presentation

Read all of this leaflet carefully before you start using this medicine.

Even if you have used Avonex before, some of the information may have changed.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your 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.

(Notes information)

Latest issue: 12/2008

This leaflet is changed from time to time.

Please check every time you get your prescription refilled to see if the leaflet has been updated.

In this leaflet: 1. What AVONEX is and what it is used for 2. Before you use AVONEX 3. How to use AVONEX 4. Possible side effects 5. How to store AVONEX 6. Further information 7. How to inject AVONEX What Avonex Is And What It Is Used For What AVONEX is

The active ingredient in Avonex is a protein called interferon beta-1a. Interferons are natural substances made in your body to help protect you from infections and diseases. The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.

What AVONEX is used for

Avonex is used to treat Multiple Sclerosis (MS). Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS.

Everyone has their own set of MS symptoms. These can include:

feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness, numbness in the face, arms or legs acute or chronic pain, bladder and bowel problems, sexual problems and problems seeing things difficulty in thinking and concentrating, depression.

MS also tends to flare up from time to time: this is called a relapse.

(Notes information)

Avonex works best when you use it at the same time, once a week, on a regular basis.

Do not stop your Avonex treatment without speaking to your neurologist.

Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS. Your doctor will advise you for how long you can use Avonex or when to stop.

How AVONEX works

Multiple sclerosis is linked to nerve (brain or spinal cord) damage. In MS, your body’s defence system reacts against it’s own myelin – the ‘insulation’ that surrounds nerve fibres. When myelin is damaged, the messages between the brain and other parts of the body are disrupted. This is what causes the symptoms of MS. Avonex seems to work by stopping your body’s defence system from attacking the myelin.

Before You Use Avonex Do not use AVONEX if you are allergic (hypersensitive) to interferon beta, human serum albumin or any of the other ingredients in Avonex if you are pregnant, do not start using Avonex if you have severe depression or think about committing suicide.

Talk to a doctor straight away if any of these apply to you.

(Notes information)

Avonex and allergic reactions. Because Avonex is based on a protein, there is a small chance of an allergic reaction.

More about depression. If you have severe depression or thoughts about suicide, you must not use Avonex.

If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods.

Take special care with AVONEX

Talk to your doctor first:

If you have or have had in the past:

depression or problems affecting your moods thoughts about committing suicide.

Changes to your mood, thoughts about suicide, feeling unusually sad, anxious or worthless, should be reported to your doctor immediately.

epilepsy or other seizure disorders not controlled by medication serious kidney or liver problems a low number of white blood cells or platelets, which can cause an increased risk of infection, bleeding or anaemia heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmias).

Talk to your doctor if you have any of these conditions, or if they worsen whilst taking Avonex.

Tell your doctor you are using AVONEX: if you are having a blood test. Avonex may interfere with the results.

(Notes information)

Sometimes you will need to remind other medical staff that you are being treated with Avonex. For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result.

Using other medicines

If you are using other medicines, especially those used to treat epilepsy or depression. Avonex may affect other medicines or be affected by them. This includes any other medicines including medicines obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant, do not start using Avonex.

If you could get pregnant, you need to use contraception while you use Avonex. If you are planning a baby or if you become pregnant while you are using Avonex, tell your doctor. You and your doctor can discuss if you should carry on with treatment. If you are already pregnant, or think that you might be, talk to a doctor as soon as you can. If you want to breastfeed talk to your doctor first. Driving and using machines

If you feel dizzy, do not drive. Avonex makes some people feel dizzy. If this happens to you, or if you get any other side effects that could affect your ability, do not drive or use machines.

Important information about some of the ingredients of AVONEX

This medicine is essentially ‘sodium-free’. It contains less than 23 mg (1 mmol) sodium in each weekly dose.

How To Use Avonex

The usual dose for adults and adolescents aged 12 years and over

One injection of Avonex, once a week.

Try to use Avonex at the same time on the same day each week.

Not for children

Avonex is not to be used in children below the age of 12 years.

Injecting yourself

You can inject Avonex yourself without the help of your doctor, if they have trained you to do this. The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX).

If you have trouble handling the syringe, ask your doctor who may be able to help.

(Notes information)

There are more details on how to inject Avonex at the end of this leaflet.

Alternate needle:

Your pack of Avonex already includes a needle for injection. It may be possible for your doctor to prescribe you a shorter and thinner needle, depending on your body type. Talk to your doctor to see if this is appropriate for you.

If you have problems handling the syringe, talk to your doctor about using a syringe grip. This is a specially designed holder to help you with injecting Avonex.

How long to use AVONEX

Your doctor will tell you how long you need to keep using Avonex. It is important to continue using Avonex regularly. Do not make changes unless your doctor tells you.

If you inject too much

You should only have one injection of Avonex, once a week. If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice.

If you miss an injection

If you miss your usual weekly dose, inject a dose as soon as you can. Then leave a week before using Avonex again. Continue injecting on this new day every week. If you have a preferred day for using Avonex, talk to your doctor about managing the dose, to get back to your preferred day.

Do not use two injections to make up for a missed injection.

Possible Side Effects

Like all medicines, Avonex can cause side effects, although not everyone gets them.

(Notes information)

Although the list of possible side effects can seem worrying, it’s possible that you may not have any of them.

Serious side effects: get medical help

Serious allergic reactions

If you get any of these:

swelling of the face, lips or tongue difficulty breathing a rash.

Call a doctor immediately. Do not use any more Avonex until you have spoken to a doctor.

Depression

If you get any symptoms of depression:

feeling unusually sad, anxious or worthless.

Call a doctor immediately.

Liver problems

If you get any of these symptoms:

yellowing of your skin or the whites of your eyes (jaundice) itching all over feeling sick, being sick (nausea and vomiting) easy bruising of the skin.

Call a doctor immediately as they may be signs of a possible liver problem.

Side effects seen in clinical trials

(Notes information)

Side effects seen in clinical trials. These are the side effects that people reported when Avonex was being tested. The figures are based on how many people said they’d had them. It gives you an idea how likely you are to get similar side effects.

Very common side effects
(at least 1 in 10 people are affected)

flu-like symptoms – headache, muscle aches, chills or a fever: see Flu-like symptoms, below headache.

Common side effects
(less than 1 in 10 people are affected)

loss of appetite feeling weak and tired difficulty sleeping depression flushing runny nose diarrhoea (loose stools) feeling or being sick (nausea or vomiting) numbness or tingling of skin rash, bruising of the skin increased sweating, night sweats pain in your muscles, joints, arms, legs or neck muscle cramps, stiffness in the joints and muscles pain, bruising and redness at the injection site changes to blood tests. Symptoms you might notice are tiredness, repeated infection, unexplained bruising or bleeding.

Uncommon side effects
(less than 1 in 100 people affected)

hair loss changes to your monthly period burning feeling at the site of injection.

Rare side effects
(less than 1 in 1,000 people affected)

difficulty breathing.

If any of the effects trouble you, talk to your doctor.

Other side effects

(Notes information)

These effects have been seen in people using Avonex, but we do not know how likely they are to happen.

an underactive or overactive thyroid nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (seeing or hearing things that are not real), confusion or suicide numbness, dizziness, seizures or fits and migraines an awareness of your heartbeat (palpitations), a rapid or irregular heartbeat, or heart problems which would have the following symptoms: a reduced ability to exercise, inability to lie flat in bed, shortness of breath or swollen ankles liver problems as described above nettle rash or blister-like rash, itching, worsening of psoriasis if you have it swelling or bleeding at the site of injection, or chest pain after an injection gaining or losing weight changes to test results, including changes to liver function tests.

If any of the effects trouble you, talk to your doctor.

Effects of the injection Feeling faint: Your first injection of Avonex may be given by your doctor. It may make you feel faint. You may even actually faint. This is unlikely to happen again. Just after an injection, your muscles may feel tense or very weak – as though you are having a relapse. This is rare. It only happens when you inject and the effects soon pass. They may happen any time after starting on Avonex. If you notice any irritation or skin problems after an injection, talk to your doctor.

Flu-like symptoms

(Notes information)

Three simple ways to help reduce the impact of flu-like symptoms:

1. Use your Avonex injection just before bedtime. This may allow you to sleep through the effects. 2. Take paracetamol or ibuprofen half an hour before your Avonex injection and continue taking it for up to a day. Speak to your doctor or pharmacist about a suitable dose. 3. If you have a fever, drink plenty of water to keep you hydrated.

Some people find that after injecting Avonex, they feel like they have flu. Signs are:

headache muscle aches chills or a fever.

These symptoms are not really flu.

You can’t pass it on to anyone else. They are more common when you first start using Avonex. As you keep using your injections, the flu-like symptoms gradually decrease.

How To Store Avonex

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the label.

Store below 25 °C.

Once prepared in the syringe use as soon as possible. However, the prepared syringe can be stored in the fridge (between 2 °C and 8 °C) for up to 6 hours before you inject. Do not freeze.

Bring it out half an hour before injecting.

Do NOT use AVONEX if you notice:

The seal of the cap of the BIO-SET device is broken. The sealed plastic tray is damaged or opened. The liquid in the vial obtained after reconstitution is not colourless or slightly yellow in colour or you can see particles floating in it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information Ingredients

The active ingredient is: Interferon-beta 1a 30 micrograms

The other ingredients are: Human serum albumin, sodium chloride, dibasic sodium phosphate and monobasic sodium phosphate.

What is in your Avonex pack

A box of Avonex Bioset has four doses of Avonex.

Each dose comes in a sealed plastic tray and has a white to off-white coloured powder in a glass container (vial) and an injection syringe filled with water. These are mixed together to make up the injection you take (solution for injection). A separate needle to give the injection is also included in the tray.

Marketing Authorisation Holder is: Biogen Idec Limited Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom Avonex is made by: Biogen Idec BV Robijnlaan 8 NL-2132 WX Hoofddorp The Netherlands Biogen Idec Denmark Manufacturing ApS Biogen Idec All? 1 DK-3400 Hiller?d Denmark

You can get a larger print version of this leaflet by calling the local representatives.

For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Biogen Idec Limited Tel:+44 (0) 1628 50 1000

This leaflet was last approved in 12/2008

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu

How To Inject Avonex

You should have had training in how to inject Avonex.

These notes are a reminder. If there’s anything you’re not sure about, check with your doctor or pharmacist.

Where to inject Avonex is injected into a muscle, for example, the upper thigh muscle. Injection of Avonex into the buttocks is not recommended. Use a different injection site each week. This means less risk of irritation to your skin and muscle. Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound. A Getting ready 1. Take a tray out of the box.

Check the expiry date on the lid of the tray. Do not use it if it is out-of-date.

Peel back the paper lid completely. Check the blister tray contains:

one BIO-SET (vial + base + cap) one syringe one injection needle (see picture “Contents of the plastic tray”). 2. Wash your hands thoroughly with soap and water and dry them. 3. Prepare alcohol wipes and sticking plasters (not supplied) if you need them. 4. Find a clean, hard surface to lay out the items needed for your injection. Lay the tray down on it. B. Preparing the injection 1 Remove cap off the vial
Twist, then pull cap off.
Do not touch the connection port. 2 Pull the cap off the syringe
Hold the base of the syringe. Pull the cap off.
Do not touch the connection port.
Do not push on the plunger. 3 Line up the syringe and vial
Place the Bio-Set on a flat surface.
Line up the two connection ports so that they are in a straight line.
Hold the syringe by the base. Screw it firmly clockwise into the vial. 4 Push the syringe down until it clicks
Keep the Bio-Set on the flat surface and hold the syringe by the base.
Keep them in a straight line.
Tip: If the syringe is at an angle to the Bio-Set, it will leak.
Push the syringe until it clicks. 5 Mix the water and powder
Slowly inject all the water from the syringe into the vial.
Tip: Don’t push the plunger quickly. This turns the solution to foam that can’t be drawn into the syringe.
Push the plunger right down to get air out of the syringe. 6 Dissolve the powder fully
Pick up the vial and the syringe, keeping them attached and straight.
Gently swirl the vial until all the powder has dissolved.
Do not shake: this will make froth. 7 Fill the syringe
Turn the syringe and vial upside down, still in a straight line.
Tip: If the syringe is at an angle to the Bio-Set, it will leak.
Slowly pull the plunger until all the liquid is in the syringe. 8 Separate syringe and vial
Hold the filled syringe by the base. Turn it anti-clockwise to remove it from the Bio-Set vial.
Do not touch the connection port on the syringe. C: Giving the injection 1 Check the liquid in the syringe
It should be clear and colourless.
If the solution is any colour except colourless or slightly yellow, or if you can see particles floating in it, do not inject. 2 Fit the needle
Unwrap the needle to expose the connection port. Keep the cover on.
Push and twist the needle clockwise onto the syringe.
Now pull off the plastic needle cover.
Do not twist it.
Tip: If you twist the needle cover to remove it, you may accidentally remove the needle as well. 3 Remove any air
To remove air, point the syringe needle upwards. Gently tap to bring air bubbles to the top.
Push the plunger carefully to remove the air. Don’t let more than a small drop of liquid escape. 4 Clean and stretch the injection site
If you need to, use an alcohol wipe to clean the skin at the injection site you’ve chosen. Allow the skin to dry.
With one hand, stretch the skin around the injection site.
Relax your muscle.
5 Make the injection
Insert the injection needle with a quick dart-like thrust at right angles to the skin, into the muscle
The needle must go all the way in.
Press the plunger slowly until the syringe is empty. 6 Pull the needle out
Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
If you use alcohol wipes, hold one on the injection site.
Put a plaster over the site of injection if you need to.
Dispose of the rubbish properly
After you have finished each injection, put the needle, syringe and vial into a special container (such as a sharps bin), not in ordinary rubbish. Waste paper and used wipes can be put in an ordinary rubbish bin.
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E45 Cream (Forum Health Products Limited )


1. Name Of The Medicinal Product

E45 Cream

2. Qualitative And Quantitative Composition

Anhydrous Lanolin

 

1.0%

w/w

White Soft Paraffin

BP

14.5%

w/w

Light Liquid Paraffin

PhEur

12.6%

w/w

3. Pharmaceutical Form

A cream

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, traumatic dermatitis, sunburn, the dry stage of eczema and certain dry cases of psoriasis.

4.2 Posology And Method Of Administration

For topical application.

Adults, Children, Babies and the Elderly - Apply to the affected part two or three times daily.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The labelling states:

For external use only.

If symptoms persist, consult your doctor.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions known.

4.6 Pregnancy And Lactation

The safety of E45 Cream in pregnancy and lactation has not been assessed but is thought unlikely to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely, but should they occur, may take the form of an allergic rash. Should this occur, use of the product should be discontinued.

4.9 Overdose

E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no pre-clinical safety data of relevance to the consumer.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Empilan GMS, cetyl alcohol, sodium cetostearyl sulphate, carbomer, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, citric acid monohydrate, purified water.

6.2 Incompatibilities

Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.

6.3 Shelf Life

Aluminium tubes and polypropylene tubs: 3 years.

All other containers: 2 years.

6.4 Special Precautions For Storage

Store below 25°C for polyethylene tubes and pump pack, made of polypropylene and polyethylene and consisting of a plastic bottle and a pump system with a dip tube. None for aluminium tubes and polypropylene tubs.

6.5 Nature And Contents Of Container

A collapsible aluminium tube, internally lacquered with a membrane seal and plastic screw cap. Pack sizes: 15, 50 or 100 g.

(The 100 g tube is for dispensing only. One hundred tubes will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)

A polyethylene tube with membrane seal and plastic screw cap. Pack sizes 15 or 50 g.

A polypropylene securipot with a white polythene pilfer-proof screw cap. Pack sizes: 125, 350 or 500 g.

A white polypropylene jar with a white polyethylene push-on, tamper-evident closure. Pack sizes: 250, 300 or 500 g.

((The 500 g jar is for dispensing only. Thirty-six jars will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)

A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or polypropylene dispenser having a polythene covered follower plate.

Pack sizes: 500 or 900 g.

A pump pack made of polypropylene and polyethylene, consisting of a plastic bottle and a pump system with a dip tube. Pack size: 500 g.

A pump pack made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g

Not all pack sizes are necessarily marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Wellcroft Road

Slough,

SL1 4AQ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0404

9. Date Of First Authorisation/Renewal Of The Authorisation

25th September 1991

10. Date Of Revision Of The Text

07/10/2011

11 DOSIMETRY

IF APPLICABLE

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

IF APPLICABLE


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Skin Cancer Medications


Definition of Skin Cancer:

Skin cancer is the uncontrolled growth of skin cells. If left unchecked, these cancer cells can spread from the skin into other tissues and organs.

There are different types of skin cancer. Basal cell carncinoma is the most common. Melanoma is less common, but more dangerous.

Drugs associated with Skin Cancer

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

Topics under Skin Cancer Basal Cell Carcinoma (6 drugs) Melanoma (16 drugs in 2 topics) Squamous Cell Carcinoma (2 drugs) Learn more about Skin Cancer

Micromedex Care Notes:

Liposarcoma Squamous Cell Carcinoma

Medical Encyclopedia:

Skin cancer

Drugs.com Health Center:

Skin Cancer
Drug List: Carac-Cream Efudex-Cream Efudex-Occlusion-Pack Fluoroplex-Cream
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Allergy Relief Tablets


loratadine
Dosage Form: tablet
Drug Facts Active ingredient

loratadine 10mg

Purpose

antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Warnings Adverse Reactions Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When Using

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children.

Overdose

In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only) safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only) store at 20-25°C (68-77°F) (see USP Controlled Room Temperature) Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions

call 1-800-452-0051

 

 Distributed by Target Corp.

Minneapolis, MN 55403

copyright 2009 Target Brands, Inc.

All Rights Persevered

Principal Display

Target


ALLERGY RELIEF MEDICATION 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-315 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code GG;296 Contains          Packaging # NDC Package Description Multilevel Packaging 1 11673-315-10 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 5 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-10) 2 11673-315-40 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-40) 3 11673-315-18 1 BOTTLE In 1 CARTON contains a BOTTLE 3 180 TABLET In 1 BOTTLE This package is contained within the CARTON (11673-315-18) 4 11673-315-60 6 BLISTER PACK In 1 CARTON contains a BLISTER PACK 4 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-60) 5 11673-315-30 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-30) 6 11673-315-15 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 6 5 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA075209 01/31/2010
Labeler - Target Brands, Inc. (006961700) Revised: 09/2010Target Brands, Inc. More Allergy Relief Tablets resources Allergy Relief Tablets Side Effects (in more detail) Allergy Relief Tablets Dosage Allergy Relief Tablets Use in Pregnancy & Breastfeeding Allergy Relief Tablets Drug Interactions 0 Reviews for Allergy Reliefs - Add your own review/rating Compare Allergy Relief Tablets with other medications Hay Fever Urticaria
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Meningitis, Listeriosis Medications


Drugs associated with Meningitis, Listeriosis

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


Drug List: Baycadron De-Sone-La-Injection Decadron Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Solurex-Injection Solurex-La-Injection Zema-Pak-10-Day
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Mycobacterium avium-intracellulare, Treatment Medications


Drugs associated with Mycobacterium avium-intracellulare, Treatment

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


Drug List: Azithromycin-3-Day-Dose-Pack Biaxin Biaxin-Xl-Extended-Release-Tablets Cipro Cipro-I-V Cipro-Xr-Extended-Release-Tablets Floxin Myambutol Mycobutin Zithromax Zmax-Extended-Release-Oral-Suspension
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