msds sheets Tresaderm Solution - 15ml - 12/box
 

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Tresaderm



Dosage Form: FOR ANIMAL USE ONLY
Tresaderm®
(thiabendazole, dexamethasone, neomycin sulfate solution)

NADA 042-633, Approved by the FDA.

Dermatologic Solution CAUTION

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Tresaderm Description

Dermatologic Solution Tresaderm® (thiabendazole, dexamethasone, neomycin sulfate solution) contains the following active ingredients per mL: 40 mg thiabendazole, 1 mg dexamethasone, 3.2 mg neomycin (from neomycin sulfate). Inactive ingredients: glycerin, propylene glycol, purified water, hypophosphorous acid, calcium hypophosphite; about 8.5% ethyl alcohol and about 0.5% benzyl alcohol.

INDICATIONS

Dermatologic Solution Tresaderm is indicated as an aid in the treatment of certain bacterial, mycotic, and inflammatory dermatoses and otitis externa in dogs and cats. Both acute and chronic forms of these skin disorders respond to treatment with Tresaderm. Many forms of dermatosis are caused by bacteria (chiefly Staphylococcus aureus, Proteus vulgaris and Pseudomonas aeruginosa). Moreover, these organisms often act as opportunistic or concurrent pathogens that may complicate already established mycotic skin disorders, or otoacariasis caused by Otodectes cynotis. The principal etiologic agents of dermatomycoses in dogs and cats are species of the genera Microsporum and Trichophyton. The efficacy of neomycin as an antibacterial agent, with activity against both gram-negative and gram-positive pathogens, is well documented. Detailed studies in various laboratories have verified the significant activity thiabendazole displays against the important dermatophytes. Dexamethasone, a synthetic adrenocorticoid steroid, inhibits the reaction of connective tissue to injury and suppresses the classic inflammatory manifestations of skin disease. The formulation for Tresaderm combines these several activities in a complementary form for control of the discomfort and direct treatment of dermatitis and otitis externa produced by the above-mentioned infectious agents.

Tresaderm Dosage and Administration

Prior to the administration of Dermatologic Solution Tresaderm, remove the ceruminous, purulent or foreign materials from the ear canal, as well as the crust which may be associated with dermatoses affecting other parts of the body. The design of the container nozzle safely allows partial insertion into the ear canal for ease of administration. The amount to apply and the frequency of treatment are dependent upon the severity and extent of the lesions. Five to 15 drops should be instilled in the ear twice daily. In treating dermatoses affecting other than the ear the surface of the lesions should be well moistened (2 to 4 drops per square inch) with Dermatologic Solution Tresaderm twice daily. The volume required will be dependent upon the size of the lesion.

Application of Tresaderm should be limited to a period of not longer than one week.

Precautions

On rare occasions dogs may be sensitive to neomycin. In these animals, application of the drug will result in erythema of the treated area, which may last 24 to 48 hours. Also, evidence of transient discomfort has been noted in some dogs when the drug was applied to fissured or denuded areas. The expression of pain may last 2 to 5 minutes. Application of Dermatologic Solution Tresaderm should be limited to periods not longer than one week.

While systemic side effects are not likely with topically applied corticosteroids, such a possibility should be considered if use of the solution is extensive and prolonged. If signs of salt and water retention or potassium excretion are noticed (increased thirst, weakness, lethargy, oliguria, gastrointestinal disturbances or tachycardia), treatment should be discontinued and appropriate measures taken to correct the electrolyte and fluid imbalance.

Store in a refrigerator 36 - 46°F (2 - 8°C).

Warning

For topical use in dogs and cats.
Avoid contact with eyes.

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 in users, to obtain an MSDS, or for assistance call 1-888-637-4251.

How is Tresaderm Supplied

Product 55871 - Dermatologic Solution Tresaderm Veterinary is supplied in 7.5 mL and 15 mL dropper bottles, each in 12 bottle boxes.

Marketed by
Merial Limited
Duluth, Georgia 30096-4640

(Merial Limited: Registered in England and Wales [Reg. No. 3332751] with registered offices at 27 Knightsbridge, London, SW1X 7QT, England and domesticated in Delaware, USA as Merial LLC).

© 2000 Merial. All rights reserved.

January 2002

Tresaderm is a registered trademark of Merial.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

15 mL

Tresaderm ®
(thiabendazole, dexamethasone,
neomycin sulfate solution)

Dermatologic Solution

CAUTION: Federal (U.S.A.) law
restricts this drug to use by or on
the order of a licensed veterinarian.

Marketed by: Merial LLC,
Duluth, GA 30096-4640, U.S.A.

12 x 15 mL Bottles*

MERIAL


Tresaderm 
dexamethasone, neomycin sulfate, and thiabendazole  solution Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 50604-5587 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength dexamethasone (dexamethasone) dexamethasone 1 mg  in 1 mL neomycin sulfate (neomycin) neomycin 3.2 mg  in 1 mL thiabendazole (thiabendazole) thiabendazole 40 mg  in 1 mL Inactive Ingredients Ingredient Name Strength glycerin   propylene glycol   water   calcium hypophosphite   alcohol   benzyl alcohol   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 50604-5587-3 12 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC (50604-5587-1) 1 50604-5587-1 7.5 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50604-5587-3) 2 50604-5587-4 12 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC (50604-5587-2) 2 50604-5587-2 15 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50604-5587-4)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA042633 11/09/1971
Labeler - Merial Limited (034393582) Revised: 08/2010Merial Limited

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Care Decongestant Nasal Spray


1. Name Of The Medicinal Product

Oxymetazoline 0.05% w/v Nasal Spray

Care Decongestant Nasal Spray

2. Qualitative And Quantitative Composition

The nasal solution contains Oxymetazoline (as hydrochloride) 0.05% w/v.

For excipients, see 6.1

3. Pharmaceutical Form

Nasal spray, solution

4. Clinical Particulars 4.1 Therapeutic Indications

Oxymetazoline Nasal Spray or Care Decongestant Nasal Spray is recommended for the relief of nasal congestion in such conditions as the common cold, catarrh and hayfever.

4.2 Posology And Method Of Administration

Adults and Elderly

While holding upright the spray nozzle should be inserted into each nostril in turn and squeezed firmly twice while breathing in. The application may be repeated up to 2 times a day, or used at bedtime to give relief through the night.

Children

Not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to any component of the medicinal product.

Patients who are receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment; patients suffering from porphyria, glaucoma, coronary artery disease, hypertension, hyperthyroidism or diabetes.

4.4 Special Warnings And Precautions For Use

If symptoms persist, consult your doctor. Prolonged use may result in rhinitis medicamentosa and should therefore be avoided. Treatment should be limited to a maximum of seven days. Keep all medicines safely away from children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

If you are taking other medicines, you should see your doctor for advice before taking this medicine.

4.6 Pregnancy And Lactation

The safety to use in pregnancy has not been established and administration of oxymetazoline during pregnancy should be avoided.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that it may cause local skin reactions (e.g. contact dermatitis) and discolouration.

Benzalkonium chloride may cause local skin irritation.

4.9 Overdose

No statement.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group (ATC code): S01G A04 Sympathomimetics used as decongestants.

Oxymetazoline is an alpha-adrenoceptor agonist which causes local vasoconstriction when applied to nasal membrane.

5.2 Pharmacokinetic Properties

When applied locally to nasal mucosa, oxymetazoline acts within a few minutes and its effects last for up to 12 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzalkonium chloride

Thiomersal

Sodium chloride

Levomenthol

Cineole

Camphor

Methyl salicylate

Poloxamer 188

Sodium citrate (dihydrate) (E331)

Citric acid (anhydrous) (E330)

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

White, low density polyethylene/polyethylene copolymer 15ml bottle.

White, high density polyethylene 15ml and 20ml bottle.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0343

9. Date Of First Authorisation/Renewal Of The Authorisation

24/01/2007

10. Date Of Revision Of The Text

20/12/2010

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable


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Carbon Dioxide Oxygen Mixture


Dosage Form: gas
Carbon Dioxide Oxygen Mixture

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

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


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

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Nazil Ofteno


naphazoline hydrochloride
Dosage Form: eye drops
DRUG FACTS

DRUG FACTS

Active Ingredient

Naphazoline Hydrochloride 0.02%

Purpose

Redness reliever

Use Relieves redness of the eye due to minor eye irritations
Warnings

For external use only

Do not use

if solution changes color or becomes cloudy

Ask a doctor before use

if you havenarrow angle glaucoma

When using this product Do not touch tip of container to any surface to avoid contamination Replace cap after using Overuse may cause more redness of the eye Puplis may become enlarged temporarily
Stop use and ask a doctor if You feel eye pain Change in vision occur Redness or irritation of the eye lasts Condition worsens Symptoms last for more than 72 hours
Keep out of reach of children

 If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Put 1 or 2 drops in the affected eye(s) up to 4 times daily

Other information Store at room temperature Remove contact lenses before using
Inactive ingredients

benzalkonium chloride (as preservative), boric acid, purified water, sodium borate, sodium chloride

Questions?

Call 1-866-282-8871

www.sophia.com.mx

Principal Display Panel

NDC 57619-300-01

Nazil Ofteno

Redness Reliever Eyedrops

0.5 FL OZ (15mL)

Sterile


NAZIL  OFTENO
naphazoline hydrochloride  solution/ drops Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 57619-300 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Naphazoline Hydrochloride (Naphazoline) Naphazoline Hydrochloride 0.20 mg  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 57619-300-01 1 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 1 15 mL In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (57619-300-01)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 04/12/2010
Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636) Establishment Name Address ID/FEI Operations LABORATORIOS SOPHIA, S.A. DE C.V. 810143636 manufacture Revised: 04/2010LABORATORIOS SOPHIA, S.A. DE C.V.
More Nazil Ofteno resources Nazil Ofteno Dosage Nazil Ofteno Use in Pregnancy & Breastfeeding Nazil Ofteno Drug Interactions 0 Reviews for Nazil Ofteno - Add your own review/rating Compare Nazil Ofteno with other medications Eye Dryness/Redness Eye Redness/Itching
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Heliox



Dosage Form: gas
COMPRESSED GAS N.O.S. (HELIUM, OXYGEN 20) LABEL

COMPRESSED GAS, N.O.S. (HELIUM, OXYGEN) NON-FLAMMABLE GAS 2 UN 1956

MEDICAL GAS MIXTURE   BALANCE HELIUM, USP  CAS:   7440-59-7  20.0%OXYGEN, USP   CAS:   7782-44-7

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. RX ONLY.

WARNING: HIGH PRESSURE GAS. MAY ACCELERATE COMBUSTION.

KEEP OIL AND GREASE AWAY. USE ONLY USE WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USE EQUIPMENT RATED FOR CYLINDER PRESSURE. STORE AND USE WITH ADEQUATE VENTILATION. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. OPEN VALVE SLOWLY. ADMINISTRATION OF THIS GAS MIXTURE MAY BE HAZARDOUS OR CONTRAINDICATED. FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF GAS MIXTURES AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN. USE IN ACCORDANCE WITH THE APPROPRIATE MSDS FOR EACH MIXTURE COMPONENT. SECURE CYLINDER WHILE IN TRANSPORTATION, STORAGE AND IN USE.

FIRST AID: IF INHALED, REMOVE TO FRESH AIR. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. IF BREATHING IS DIFFICULT, GIVE OXYGEN. CALL A PHYSICIAN.

SERIAL NUMBER:  0000000   LOT NO:  0000000 - VOLUME: 204.1 - EXP. DATE: 1/1/2015 VER. 3.11

FOR MEDICAL USE ONLY   DO NOT REMOVE THIS PRODUCT LABEL

COMPRESSED GAS N.O.S. (HELIUM, OXYGEN 25) LABEL

COMPRESSED GAS, OXIDIZING, N.O.S. (OXYGEN, HELIUM) NON-FLAMMABLE GAS 2 OXIDIZER 5.1 UN 3156

MEDICAL GAS MIXTURE  25.0% OXYGEN USP   CAS:  7782-44-7  BALANCE HELIUM, USP   CAS:   7440-59-7

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. RX ONLY.

WARNING: OXIDIZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION.

KEEP OIL AND GREASE AWAY. USE ONLY USE WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USE EQUIPMENT RATED FOR CYLINDER PRESSURE. STORE AND USE WITH ADEQUATE VENTILATION. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. OPEN VALVE SLOWLY. ADMINISTRATION OF THIS GAS MIXTURE MAY BE HAZARDOUS OR CONTRAINDICATED. FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF GAS MIXTURES AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN. USE IN ACCORDANCE WITH THE APPROPRIATE MSDS FOR EACH MIXTURE COMPONENT. SECURE CYLINDER WHILE IN TRANSPORTATION, STORAGE AND IN USE.
FIRST AID: IF INHALED, REMOVE TO FRESH AIR. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. IF BREATHING IS DIFFICULT, GIVE OXYGEN. CALL A PHYSICIAN.
SERIAL NUMBER: 0000000   LOT NO:0000000 - VOLUME: 200 - EXP. DATE: 1/1/2015 VER. 3.11
FOR MEDICAL USE ONLY. DO NOT REMOVE THIS PRODUCT LABEL.

COMPRESSED GAS N.O.S. (HELIUM, OXYGEN 30) LABEL

COMPRESSED GAS, OXIDIZING, N.O.S. (HELIUM, OXYGEN) NON-FLAMMABLE GAS 2  OXIDIZER 5.1  UN 3156

MEDICAL GAS MIXTURE  BALANCE HELIUM, USP   CAS:   7440-59-7  30.0% OXYGEN, USP   CAS:   7782-44-7

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. RX ONLY.

WARNING: OXIDIZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION.

KEEP OIL AND GREASE AWAY. USE ONLY USE WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USE EQUIPMENT RATED FOR CYLINDER PRESSURE. STORE AND USE WITH ADEQUATE VENTILATION. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. OPEN VALVE SLOWLY. ADMINISTRATION OF THIS GAS MIXTURE MAY BE HAZARDOUS OR CONTRAINDICATED. FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF GAS MIXTURES AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN. USE IN ACCORDANCE WITH THE APPROPRIATE MSDS FOR EACH MIXTURE COMPONENT. SECURE CYLINDER WHILE IN TRANSPORTATION, STORAGE AND IN USE.
FIRST AID: IF INHALED, REMOVE TO FRESH AIR. IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION. IF BREATHING IS DIFFICULT, GIVE OXYGEN. CALL A PHYSICIAN.
SERIAL NUMBER:  00000000   LOT NO.:0000000 - VOLUME: 204.1 - EXP. DATE: 1/1/2013 VER. 3.11
FOR MEDICAL USE ONLY.  DO NOT REMOVE THIS PRODUCT LABEL.







Heliox 
Heliox  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10006-009 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (OXYGEN) OXYGEN 20 L  in 100 L Inactive Ingredients Ingredient Name Strength HELIUM 80 L  in 100 L Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10006-009-01 6032 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1936
Heliox 
Heliox  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10006-010 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (OXYGEN) OXYGEN 25 L  in 100 L Inactive Ingredients Ingredient Name Strength HELIUM 75 L  in 100 L Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10006-010-01 6032 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1936
Heliox 
Heliox  gas Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10006-011 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (OXYGEN) OXYGEN 30 L  in 100 L Inactive Ingredients Ingredient Name Strength HELIUM 70 L  in 100 L Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10006-011-01 6032 L In 1 CYLINDER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1936
Labeler - Acetylene Oxygen Company (008110181) Registrant - Acetylene Oxygen Company (008110181) Establishment Name Address ID/FEI Operations Acetylene Oxygen Company 809889033 manufacture Revised: 04/2011Acetylene Oxygen Company
More Heliox resources Heliox Drug Interactions Heliox Support Group 0 Reviews · Be the first to review/rate this drug
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Pabrinex Intravenous High Potency Injection


1. Name Of The Medicinal Product

Pabrinex Intravenous High Potency, Solution for injection

2. Qualitative And Quantitative Composition

Each presentation (carton) contains either 5ml or 10ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2.

Each No 1 ampoule contains: 5ml ampoule 10ml ampoule Thiamine Hydrochloride BP 250mg 500mg Riboflavin (as Phosphate Sodium BP) 4mg 8mg Pyridoxine Hydrochloride BP 50mg 100mg Each No 2 ampoule contains: 5ml ampoule 10ml ampoule Ascorbic Acid BP 500mg 1000mg Nicotinamide BP 160mg 320mg Anhydrous Glucose BP 1000mg 2000mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection

4. Clinical Particulars 4.1 Therapeutic Indications

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy; after acute infections, post-operatively and in psychiatric states. Also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.

4.2 Posology And Method Of Administration

Pabrinex is also available as an Intramuscular High Potency Injection. Therefore before administration, ensure that both the Summary of Product Characteristics and ampoule labels refer to the INTRAVENOUS injection.

1) The preferred method of administration of Pabrinex Intravenous High Potency is by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50ml to 100ml physiological saline or glucose 5% and infused over 30 minutes (see “Special Precautions for Storage” section).

2) For a combined injection volume of not more than 10ml (e.g. the contents of one 5ml ampoule number 1 and one 5ml ampoule number 2) the contents of the ampoules are drawn up into a syringe to mix them just before use, then injected slowly, over a period of 10 minutes, into a vein.

Adults:

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy    

10ml solution from Ampoule

Number 1

PLUS

10ml solution from Ampoule

Number 2

OR

   

15ml solution from Ampoule

Number 1

PLUS

15ml solution from Ampoule

Number 2

2 to 3 pairs of 5ml ampoules* (1 pair = ampoule 1 + ampoule 2) diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) and administered over 30 minutes every 8 hours, or at the discretion of the physician.

* or equivalent volume of 5ml and/or 10ml ampoules

    Psychosis following narcosis or E.C.T; toxicity from acute infections    

5ml Ampoule Number 1

PLUS

5ml Ampoule Number 2

10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes twice daily for up to 7 days.

    Haemodialysis    

5ml Ampoule Number 1

PLUS

5ml Ampoule Number 2

10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes once every two weeks at the end of dialysis.

   

Elderly: as for adults.

Children: Pabrinex Intravenous High Potency is rarely indicated for administration to children, however suitable doses are as follows:

Under 6 years quarter of the adult dose 6 - 10 years third of the adult dose 10 - 14 years half to two thirds of the adult dose 14 years and over as for the adult dose 4.3 Contraindications

Known hypersensitivity to any of the active constituents or to the excipients.

4.4 Special Warnings And Precautions For Use

Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential. Initial warning signs of a reaction to Pabrinex are sneezing or mild asthma and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intravenous High Potency is administered. To minimise the risk of such events with Pabrinex Intravenous High Potency, the preferred mode of administration is by infusion over a period of 30 minutes.

This medicine is for injection into a vein only and should not be given by any other route

Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended – reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.

4.6 Pregnancy And Lactation

No adverse effects have been noted at recommended doses when used as clinically indicated.

However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. However given the nature of the product, no effects are anticipated.

4.8 Undesirable Effects

Occasionally, hypotension and mild paraesthesia from continued high doses of thiamine; occasionally mild ache at local site of injection.

4.9 Overdose

In the unlikely event of overdosage, treatment is symptomatic and supportive.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pabrinex Intravenous High Potency contains vitamins B1, B2, B6, nicotinamide, vitamin C and glucose.

ATC code: A11EB

5.2 Pharmacokinetic Properties

Not supplied.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars 6.1 List Of Excipients

Edetic acid

Sodium hydroxide

Water for Injections

6.2 Incompatibilities

If it is necessary to administer Pabrinex Intravenous High Potency in infusion, it is recommended that Pabrinex IV HP is administered in physiological saline or glucose 5%.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

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

Storage of diluted Pabrinex Intravenous High Potency

The stability of Pabrinex Intravenous High Potency in intravenous infusion fluids, at room temperature, is as follows:

Intravenous infusion fluid

In the light

Glucose 5%

7 hours

Physiological saline (sodium chloride 0.9%)

7 hours

Glucose 4.3% with sodium chloride 0.18%

4 hours

Glucose 5% with potassium chloride 0.3%

4 hours

Sodium lactate M/6

7 hours

Although no further specific data are available, the solutions are expected to be stable for longer periods when protected from light. Store diluted solutions at 2°C to 8°C if not used immediately. Do not freeze.

6.5 Nature And Contents Of Container

Pabrinex Intravenous High Potency is supplied in pairs of amber glass ampoules of 5ml or 10ml. Pack sizes contain ten pairs of 5ml or five pairs of 10ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

7. Marketing Authorisation Holder

Archimedes Pharma UK Limited

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

UK

8. Marketing Authorisation Number(S)

PL 12406/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: October 1993

Date of the latest renewal: October 2003

10. Date Of Revision Of The Text

22 July 2010


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Vicks Sinex Decongestant Nasal Spray


1. Name Of The Medicinal Product

Vicks Sinex Decongestant Nasal Spray

2. Qualitative And Quantitative Composition

ACTIVE INGREDIENT

 

 

Percentage quantity

Specification

Oxymetazoline hydrochloride

0.050% w/v

Ph. Eur

3. Pharmaceutical Form

Non-pressurised, aqueous nasal spray solution.

4. Clinical Particulars 4.1 Therapeutic Indications

The symptomatic relief of congestion of the upper respiratory tract due to the common cold, hay fever and sinusitis.

4.2 Posology And Method Of Administration

Adults and children over 12 years:

1-2 sprays per nostril every 6-8 hours unless otherwise advised by your doctor.

Topical application as a nasal spray.

4.3 Contraindications

See your doctor for advice before taking this medicine if you suffer from high blood pressure, any heart complaint, diabetes, thyroid disease, hepatic or renal disorders.

4.4 Special Warnings And Precautions For Use

See your doctor if you feel worse or do not feel better after 7 days. Inform your doctor if you develop new symptoms.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

If you are taking other medicines, you should see your doctor for advice before taking this medicine.

4.6 Pregnancy And Lactation

Before using this medicine, obtain advice from your doctor if you intend to become pregnant, are pregnant or are breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

4.9.1 Symptoms

No information.

4.9.2 Treatment of overdose

No information.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Oxymetazoline hydrochloride:

?-Adrenergic imidazoline derivative, providing localised nasal vasoconstriction.

5.2 Pharmacokinetic Properties

Not applicable. The product provides purely local action.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Menthol

Eucalyptol

Sodium citrate dihydrate

Tyloxapol

Citric acid anhydrous

Chlorhexidine digluconate

Benzalkonium chloride

Camphor

Disodium edetate

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

15ml or 20ml polyethylene/polypropylene copolymer bottle with L. D polyethylene dip tube to spray orifice. Green polypropylene screw cap.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Procter & Gamble (Health & Beauty Care) Limited

The Heights,

Brooklands,

Weybridge,

Surrey

KT13 0XP

8. Marketing Authorisation Number(S)

PL 0129/5011R

9. Date Of First Authorisation/Renewal Of The Authorisation

12th June 1990

10. Date Of Revision Of The Text

June 2009


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Nitrogen Liquid


Dosage Form: liquid
Nitrogen, Refrigerated Liquid

NITROGEN,

REFRIGERATED

LIQUID NF



UN 1977 Rx ONLY


NON-FLAMMABLE
GAS
2
SCHWARCZ
LIQUID NITROGEN SERVICE, INC.
CRYOGENIC SPECIALISTS
(310) 659-8146
(800) 723-5882
LOS ANGELES, CA 90035-2435
ALWAYS KEEP CONTAINER IN UPRIGHT POSITION
WWW.SCRYO.COM
WARNING! EXTREMELY COLD LIQUID GAS
CAN CAUSE SEVERE FROSTBITE
CAN CAUSE RAPID SUFFOCATION
MAY CAUSE DIZZINESS AND DROWSINESS
Rx ONLY
WARNING: Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken.
Do not drop. Use hand truck for container movement. Do not get liquid in eyes, on skin, or clothing. Store and use with adequate ventilation. Close valve when not in use and when empty. For liquid withdrawal, wear face shield or goggles, and gloves. Use in accord with Praxair, Inc. Form L-4630 (MSDS), safe practices booklet l-3499, and manufacturer's operating instructions for this container.
FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration, preferably mouth-to-mouth. If breathing is difficult, give oxygen.
NITROGEN, REFRIGERATED 
nitrogen  liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42392-001 Route of Administration RESPIRATORY (INHALATION) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGEN (NITROGEN) NITROGEN 1 L  in 1 L Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 42392-001-00 160 L In 1 DEWAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 02/01/2012
Labeler - Schwarcz Liquid Nitrogen Service, Inc. (600829014) Registrant - Schwarcz Liquid Nitrogen Service, Inc. (600829014) Establishment Name Address ID/FEI Operations Schwarcz Liquid Nitrogen Service, Inc. 600829014 manufacture Revised: 02/2012Schwarcz Liquid Nitrogen Service, Inc.

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Hemoban



Dosage Form: solution
Hemoban

DIRECTIONS FOR USE

REF 10808 – Hemoban – 1oz/30mL
NPN 00638331
For dental use only.
USA: Rx only.

1. DESCRIPTION

Hemoban is formulated to control minor hemorrhage during dental restorative procedures. Hemoban may be used on a cotton pellet or more commonly with retraction cord. Hemoban contains 25% aluminum chloride.

2. INDICATIONS

Indicated for the control of minor hemorrhage during dental restorative procedures.

3. CONTRAINDICATIONS

This product should not be used with individuals with known sensitivities to aluminum chloride.

4. PRECAUTIONS

Use only as directed. Hemoban may interfere with the setting reactions of dental materials, specifically addition-type (VPS) silicone impression materials. To prevent a setting failure, gently rinse the tissue after the hemostasis has been achieved.

5. WARNINGS

Do not swallow. Keep out of reach of children. For professional dental use only.

6. DOSAGE AND ADMINISTRATION Dispense a small amount of Hemoban into a clean dappen dish or disposable cup. For hemorrhage control prior to making a restorative impression, soak a suitable length of retraction cord in Hemoban, then using a cord-packing instrument, place the retraction cord into the gingival sulcus. Hemoban is compatible with all impression techniques – though it is recommended that critical areas be gently rinsed with water prior to application of addition-type (VPS) impression materials to preclude inhibition of the setting reaction of the impression material. For minor hemorrhage control in situations other than making restorative impressions, soak a cotton pellet in Hemoban and apply for several seconds to the area, then rinse gently with water. 7. STORAGE

Store between 59°-86°F (15°-30°C). Protect from freezing.

SultanHealthcare
411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601
Toll Free: 800-637-8582 • Phone: 201-871-1232
Fax: 201-871-0321 • www.sultanhealthcare.com

Made in the USA
Form #0010801DF (R 7/22/09)

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

Sultan®

REF 10802

Hemoban
Topical Hemostatic Solution

Directions: Soak cotton tip applicator pr pledget of cotton with Hemoban.
Apply to bleeding area with pressure until hemorrhage is arrested.
(NOTE: Should a small dark coagulum appear, flush away with water.
This will have no effect on hemostatic action.)

Warning: Corrosive. Consult MSDS for more information.
Each gram contains 250mg. Aluminum Chloride in 750mg. aqueous vehicle.
Contains no Epinephrine.

Manufactured for:
SultanHealthcare
411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601
Toll Free: 800-637-8582 • Phone: 201-871-1232
Fax: 201-871-0321 • www.sultanhealthcare.com

Net Contents:
1 gallon (3.8L)

Rx Only
For Dental Use Only

LOT
EXP

Made in USA
0010802LA (R 7/23/09)


Hemoban 
aluminum chloride  solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0699-1082 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aluminum Chloride (Aluminum Cation) Aluminum Chloride 250 mg  in 1 g Inactive Ingredients Ingredient Name Strength Water   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0699-1082-08 4490.9 g In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963
Hemoban 
aluminum chloride  solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0699-1081 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aluminum Chloride (Aluminum Cation) Aluminum Chloride 250 mg  in 1 g Inactive Ingredients Ingredient Name Strength Water   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0699-1081-01 35.6 g In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963
Labeler - DSHealthcare (056296981) Establishment Name Address ID/FEI Operations DENTSPLY Caulk 083235549 MANUFACTURE Revised: 02/2010DSHealthcare

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Surolan



Dosage Form: FOR ANIMAL USE ONLY
Surolan®

otic suspension
(miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

Rx

Antifungal, antibacterial and anti-inflammatory
For otic use in dogs only

CAUTION

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

Surolan Description

Surolan contains 23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B sulfate and 5 mg/mL prednisolone acetate. Inactive ingredients are colloidal silicon dioxide and liquid paraffin.

INDICATIONS

Surolan is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Surolan Dosage and Administration

Shake well before use.

The external ear should be thoroughly cleaned and dried before the initiation of treatment. Verify that the eardrum is intact. Instill 5 drops of Surolan in the ear canal twice daily and massage the ear. Therapy should continue for 7 consecutive days.

Contraindications

Surolan is contraindicated in dogs with suspected or known hypersensitivity to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate.

Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity.

Warnings

Not for use in humans. Keep this and all drugs out of reach of children.

ANIMAL WARNINGS

Do not administer orally.

For otic use only.

Precautions

Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membranes are not ruptured.

If overgrowth of non-susceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

Long-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hypoadrenalcorticism in dogs.

The safe use of Surolan in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.

Adverse Reactions

In the field study, 161 dogs treated with Surolan were included in the safety database. Two dogs experienced reduced hearing at the end of treatment; on follow-up one dog had normal hearing capacity while the other case was lost for follow-up. The owner of another dog reported that on day 4 of treatment, build-up of the medication decreased the dog's hearing. At the end of treatment, this dog had normal hearing as assessed by the investigator. Residue build-up was reported in 1 dog and pain upon drug application in another dog.

A total of 161 dogs treated with the active control was included in the safety database and adverse reactions were reported in 8 dogs treated with the active control. One dog experienced reduced hearing at the end of treatment. Residue build-up was noted in 1 dog. Four dogs vomited during treatment, 1 dog showed red pustules on the pinna and head shaking was observed in another dog.

Foreign market experience: the following adverse events were reported voluntarily during post-approval use of the product in foreign markets: deafness, reduced hearing, topical hypersensitivity reactions and red blisters on pinna.

For a copy of the Material Safety Data Sheet (MSDS), for technical assistance or to report adverse reactions call V?toquinol USA Inc. at 1-800-835-9496.

PHARMACOLOGY

By virtue of its 3 active ingredients, Surolan has antibacterial, antifungal, and anti-inflammatory activity. Polymyxin B sulfate is a broad-spectrum polypeptide antibiotic with activity against both Gram-positive and Gram-negative species. Miconazole nitrate is a synthetic imidazole derivative with antifungal activity and antibacterial activity against Gram-positive bacteria. Moreover, synergistic effects between miconazole nitrate and polymyxin B sulfate have been demonstrated in an in vitro study(1). Prednisolone acetate is a glucocorticoid with anti-inflammatory activity. A study performed using an experimentally-induced model of ear inflammation in mice demonstrated the effectiveness of prednisolone acetate in treating ear inflammation either alone or in combination with the other active ingredients of Surolan(2).

MICROBIOLOGY

The compatibility and additive effect of each of the components in Surolan was demonstrated in a component effectiveness and non-interference study. An in vitro study of organisms collected from clinical cases of otitis externa at a veterinary teaching hospital and from dogs enrolled in the clinical effectiveness study for Surolan determined that polymyxin B sulfate and miconazole nitrate inhibit the growth of bacteria and yeast commonly associated with canine otitis externa. Furthermore, a synergistic effect of the two antimicrobials was demonstrated. The addition of prednisolone acetate to the combination did not impair antimicrobial activity to any clinically-significant extent.

ANIMAL SAFETY

The following adverse reactions were reported in a study when Surolan was administered at 1X, 3X and 5X for 42 consecutive days (6 times the recommended treatment duration) in laboratory Beagles: hypersensitivity reactions which included mild erythema and hyperemia, painful and sensitive ear canals on examination, changes in hematology, clinical chemistry and urinalysis values consistent with the systemic absorption of topical corticosteroids, and veterinary observations of pale ear canals.

EFFECTIVENESS

Of 337 dogs enrolled in the field study, 176 dogs were included in the effectiveness database; 91 were treated with Surolan and 85 were treated with an FDA-approved active control. Clinical evaluations of otitis externa included pain/discomfort, swelling, redness, and exudate. A non-inferiority evaluation was used to compare Surolan with the active control with respect to each clinical sign of otitis externa and overall clinical improvement. Surolan was determined to be non-inferior to treatment with the active control for otitis externa. Malassezia pachydermatis and Staphylococcus pseudintermedius were identified pre-treatment in at least 10 cases that were clinically responsive to Surolan.

Table 1. Mean Percentage of Improvement in Clinical Signs of Otitis Externa Clinical sign Surolan
N=91 Active control
N=85 Pain/discomfort 94.4% 91.7% Swelling 89.1% 90.5% Redness 91.2% 86.1% Exudate 83.1% 82.1% Overall 96.7% 95.2% How is Surolan Supplied

Surolan is available in 15 mL and 30 mL plastic dispensing bottles with applicator tip for otic use.

STORAGE AND HANDLING

Store at or below 25 °C (77 °F).

NADA 141-298, Approved by FDA.

Manufactured for V?toquinol USA Inc. by:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Copyright © 2009, Janssen Animal Health

Date of most recent labeling revision: 09/2009

US - 973772

REFERENCES Pietschmann S. et al. (2009)
Synergistic effects of miconazole and polymyxin B on microbial pathogens.
Veterinary Research Communications 33(6), 489-505 Bolinder A. et al. (2006)
In vivo efficacy study of the anti-inflammatory properties of Surolan
The Canadian Journal of Veterinary Research 70, 234-236 PRINCIPAL DISPLAY PANEL - 15 mL Box

NDC 17030-947-15

Surolan®

otic suspension
(miconazole nitrate,
polymyxin B sulfate,
prednisolone acetate)

15mL

For otic use in dogs only.

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

NADA 141-298
Approved by FDA

V?toquinol


Surolan 
miconazole nitrate, polymyxin b sulfate, and prednisolone acetate  suspension/ drops Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 17030-947 Route of Administration AURICULAR (OTIC) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength miconazole nitrate (miconazole) miconazole nitrate 23 mg  in 1 mL polymyxin B sulfate (polymyxin B) polymyxin B sulfate 0.5293 mg  in 1 mL prednisolone acetate (prednisolone) prednisolone acetate 5 mg  in 1 mL Inactive Ingredients Ingredient Name Strength paraffin   Product Characteristics Color WHITE (opaque) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 17030-947-15 1 BOTTLE In 1 BOX contains a BOTTLE, WITH APPLICATOR 1 15 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the BOX (17030-947-15) 2 17030-947-30 1 BOTTLE In 1 BOX contains a BOTTLE, WITH APPLICATOR 2 30 mL In 1 BOTTLE, WITH APPLICATOR This package is contained within the BOX (17030-947-30)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141298 12/30/2009
Labeler - Vetoquinol USA Inc (106824209) Establishment Name Address ID/FEI Operations Jansen Pharmaceutica NV 370005019 MANUFACTURE Revised: 12/2009Vetoquinol USA Inc
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Zinacef


ZINACEF 1.5 g, 750 mg and 250 mg

cefuroxime sodium powder for injection

Please read this leaflet carefully before starting to take your medicine. Keep it safe, as you may want to read it again. This leaflet contains important information about Zinacef injection. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.

What is Zinacef?

Zinacef contains cefuroxime, which is an antibiotic belonging to the cephalosporin class. Antibiotics are used to kill the bacteria or “germs” which cause infections.

What Zinacef contains

Each vial contains:

The active ingredient - cefuroxime 250 mg or 750 mg or 1.5 g (as sodium salt).

Other ingredients - none.

Zinacef is supplied in single vials of cefuroxime 250 mg, 750 mg or 1.5 g.

Product licence holder and manufacturer Product licence held by Glaxo Operations UK Ltd. trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Manufactured by GlaxoSmithKline Manufacturing S.p.A. Verona Italy What Zinacef does

This medicine is used to treat infections of the airways; ear, nose and throat; urinary tract; bones and joints; pelvis; blood and wounds; gonorrhoea and meningitis.

Your doctor has decided to give you Zinacef because you have an infection or to protect you from infection before an operation or during dialysis. Sometimes Zinacef is used at the same time as other antibiotics and the correct dose is checked by blood tests.

Before having Zinacef Make sure your doctor knows: if you think you may be pregnant if you are breast-feeding if you have been told that you are allergic to Zinacef, cefuroxime or other antibiotics e.g. penicillin if you have been told that your kidneys are not working as well as they should be if you are taking a diuretic such as furosemide if you are taking an aminoglycoside type antibiotic or any other antibiotics. You and your doctor should also know that: if your urine is tested for sugar, Zinacef does not normally cause a false positive result as occurs with some other cephalosporin antibiotics if you have any blood tests, Zinacef can cause changes to the results.

Like other medicines used to treat meningitis, Zinacef may take a while to clear the body of all the meningitis infection. Because of this, hearing loss caused by meningitis has occurred in a few patients after using Zinacef to treat the disease.

Dosage and administration

The correct dose of Zinacef will be decided by your doctor and depends on the type of infection and your weight and age. Zinacef will usually be given by a doctor or nurse either directly into a vein or into a muscle. In some cases, it may be added to a “drip” intravenous infusion. Zinacef is made up by adding the following amount of sterile water or other recommended diluting solution.

Vial Size 250mg Intramuscular injection (suspension): 1ml Intravenous injection (solution): 2ml Intravenous infusion (solution): - Vial Size 750mg Intramuscular injection (suspension): 3ml Intravenous injection (solution): 6ml Intravenous infusion (solution): - Vial Size 1.5g Intramuscular injection (suspension): - Intravenous injection (solution): 15ml Intravenous infusion (solution): - Vial Size 1.5g infusion Intramuscular injection (suspension): - Intravenous injection (solution): - Intravenous infusion (solution): 50ml

The usual adult dose is from 750 mg to 1.5 g three times a day: bigger or more frequent doses are sometimes needed. The duration of treatment depends on the type of infection. In special cases, just one 1.5 g dose is sufficient.

To treat pneumonia in adults, the usual dose of Zinacef is 1.5 g, twice a day for 2 to 3 days, followed by a 7 day course of the oral form of Zinacef, called Zinnat (cefuroxime axetil).

To treat a sudden worsening of chronic bronchitis, the usual dose of Zinacef is 750 mg, twice a day for 2 to 3 days, followed by a 5 to 7 day course of Zinnat.

The duration of your treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment.

For infants and children, the dose is based on body weight and is usually between 30 mg to 100 mg per kilogram daily divided into three or four separate doses. For newborn children the dose is as for infants and children, but is divided into 2 or 3 doses.

The daily dose depends on whether it is a simple or complicated infection and on whether other antibiotics are being used at the same time.

For patients with kidney problems the dose of Zinacef will be reduced.

Your medication will usually be given to you by a health professional. However if you think you may have missed a dose or have received too much medicine please tell your doctor or nurse.

Zinacef Side Effects

Along with its needed effects, a medicine may cause unwanted effects. Most people given Zinacef find it causes no problems.

A few people can be allergic to antibiotics, if any of the following rare side effects appear soon after having your injection, tell your doctor immediately:

sudden wheeziness, chest tightness, pain or collapse, as these may be symptoms of an acute allergic reaction to your medicine. The more common side effects of Zinacef that could happen to between in 1 in 10 and 1 in 100 people taking it include: changes to “blood counts” or tests used to measure the functioning of organs in the body such as the liver pain or inflammation at the site of injection (thrombophlebitis). Uncommon side effects that could happen to between 1 in 100 and 1 in 1,000 people taking Zinacef include: skin lumps or hives skin rash (red spots), itchiness diarrhoea or vomiting. Rare side effects that could happen to between 1 in 1,000 and 1 in 10,000 people include: as with other antibiotics after long courses of treatment, thrush in the vagina or mouth can occur easy bruising (thrombocytopenia) fever. Very rare side effects that could happen to less 1 in 10,000 taking Zinacef include: swelling of eyelids, face or lips severe diarrhoea from colitis (lower end of the bowel inflamed) kidney inflammation blistering or peeling skin.

If you feel unwell or have any unusual discomfort you do not understand, tell the doctor as soon as possible.

Storage

If you keep the vials at home, keep them away from heat and light which could spoil them. As with all medicines, keep Zinacef vials safely away from children. Store any unopened vials at room temperature below 25°C (77°F). Store reconstituted vials in a fridge at 2-8°C for no longer than 24 hours. Do not autoclave (a method of sterilization often used in hospitals).

What to do with any unused medication

If you are at home and your doctor stops your treatment, return any unused Zinacef vials to a pharmacist for disposal. Only keep your medication if your doctor tells you to. Do not use the unopened vials after the expiry date on the label or carton.

Further information

Remember this medicine is for you. Only a doctor can prescribe it for you.

This leaflet does not tell you everything about your medication. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

You may be able to find out more about prescribed medicines from books in public libraries.

Leaflet last updated 3 May 2006

The information provided applies only to Zinacef

Zinacef and Zinnat are registered trademarks of the GlaxoSmithKline group of companies

© 2006 GlaxoSmithKline group of companies


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Equell



Dosage Form: FOR ANIMAL USE ONLY
Equell®
(ivermectin)
Paste 1.87%
Anthelmintic and Boticide

FOR ORAL USE IN HORSES ONLY

Removes worms and bots with a single dose.

Contents will treat up to 1320 lb body weight.

Net Weight: 0.225 oz (6.42 g)

INDICATIONS

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. Equell (ivermectin) Paste provides effective control of the following parasites in horses:

Large Strongyles (adults)
  Strongylus vulgaris (also early forms in blood vessels)
  S. edentatus (also tissue stages)
  S. equinus
  Triodontophorus spp. including T. brevicauda, T. serratus
  Craterostomum acuticaudatum

Small Strongyles (adults, including those resistant to some benzimidazole class compounds)
  Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus
  Cyathostomum spp. including C. catinatum, C. pateratum
  Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, C. brevicapsulatus
  Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, C. minutus
  Cylicodontophorus spp.
  Petrovinema poculatum

Small Strongyles (fourth-stage larvae)

Pinworms (adults and fourth-stage larvae)
  Oxyuris equi

Ascarids (adults and third- and fourth-stage larvae)
  Parascaris equorum

Hairworms (adults)
  Trichostrongylus axei

Large-mouth Stomach Worms (adults)
  Habronema muscae

Bots (oral and gastric stages)
  Gasterophilus spp. including G. intestinalis and G. nasalis

Lungworms (adults and fourth-stage larvae)
  Dictyocaulus arnfieldi

Intestinal Threadworms (adults)
  Strongyloides westeri

Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae

Dermatitis caused by Neck Threadworm microfilariae, Onchocerca sp.

Equell Dosage and Administration

This syringe contains sufficient paste to treat one 1320-lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) of body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb (114 kg) of body weight.

While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking. Lock the ring in place by making a 1/4 turn to the right. Make sure that the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the syringe tip into the horse’s mouth at the space between the teeth. Depress the plunger as far as it will go, depositing paste on the back of the tongue. Immediately raise the horse's head for a few seconds after dosing. Parasite Control Program

All horses should be included in a regular parasite control program with particular attention being paid to mares, foals, and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. Equell Paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.

Product Advantages Broad-spectrum Control

Equell Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Equell Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.

ANIMAL SAFETY

Equell Paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

Warnings

Do not use in horses intended for human consumption.

Not for use in humans. Keep this and all drugs out of reach of children. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Bimeda, Inc. at 1-888-524-6332.

Precautions

Equell Paste has been formulated specifically for use in horses only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Environmental Safety

Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

Store at room temperature (25°C/77°F), with excursions permitted between 15°- 30°C (59°- 86°F).

INFORMATION FOR HORSE OWNERS

Swelling and itching reactions after treatment with ivermectin paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp. microfilariae). These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Equell Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

ANADA 200-320, Approved by FDA

Manufactured by:
Virbac AH Inc.
3200 Meacham Blvd
Fort Worth, Texas 76137

Distributed by:
Bimeda, Inc.
Le Sueur, MN 56058

Equell is a Registered Trademark of Virbac SA.

November 2009

301981-01

PRINCIPAL DISPLAY PANEL - 6.42 g Syringe Carton

Equell®
(ivermectin)

Paste 1.87%

Anthelmintic and Boticide

Removes worms and bots with a single dose.

Contents will treat up to 1320 lb. body weight.

FOR ORAL USE IN HORSES ONLY

Net Weight: 0.225 oz (6.42 g)

ANADA 200-320, Approved by FDA

Bimeda


Equell 
ivermectin  paste Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 61133-7010 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ivermectin (Ivermectin) Ivermectin 200 ug Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 61133-7010-1 1 SYRINGE In 1 CARTON None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200320 01/14/2010
Labeler - Bimeda Inc (043653216) Registrant - Virbac AH Inc (131568396) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 MANUFACTURE Revised: 01/2010Bimeda Inc

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Zimecterin



Dosage Form: FOR ANIMAL USE ONLY
Zimecterin®
(ivermectin) 1.87% Paste INDICATIONS

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Zimecterin® (ivermectin) Paste provides effective treatment and control of the following parasites in horses.

Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus and Craterostomum acuticaudatum;
Small Strongyles (adults, including those resistant to some benzimidazole class compounds) – Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum;
Small Strongyles – Fourth-stage larvae;
Pinworms (adults and fourth-stage larvae) – Oxyuris equi;
Ascarids (adults and third- and fourth-stage larvae) – Parascaris equorum;
Hairworms (adults) – Trichostrongylus axei;
Large-mouth Stomach Worms (adults) – Habronema muscae;
Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis;
Lungworms (adults and fourth-stage larvae) – Dictyocaulus arnfieldi;
Intestinal Threadworms (adults) – Strongyloides westeri;
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae;
Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

Zimecterin Dosage and Administration

This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight. (1) While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking. (2) Lock the ring in place by making a 1/4 turn to the right. (3) Make sure that the horse's mouth contains no feed. (4) Remove the cover from the tip of the syringe. (5) Insert the syringe tip into the horse's mouth at the space between the teeth. (6) Depress the plunger as far as it will go, depositing paste on the back of the tongue. (7) Immediately raise the horse's head for a few seconds after dosing.

PARASITE CONTROL PROGRAM

All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs. Zimecterin® (ivermectin) Paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.

PRODUCT ADVANTAGES Broad-spectrum Control

Zimecterin® Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Zimecterin® Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.

ANIMAL SAFETY

Zimecterin® (ivermectin) Paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

STORAGE INFORMATION

Store at 68° F - 77° F (20-25° C). Excursions between 59° F - 86° F (15-30° C) are permitted.

Warning

Do not use in horses intended for human consumption.

Not for use in humans. Keep this and all drugs out of reach of children.
Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Merial at 1-888-637-4251.

Precautions

Zimecterin® (ivermectin) Paste has been formulated specifically for use in horses only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Environmental Safety

Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

INFORMATION FOR HORSE OWNERS

Swelling and itching reactions after treatment with Zimecterin® (ivermectin) Paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp.) microfilariae. These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Zimecterin® Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

Manufactured by: Merial Sa?de Animal Ltda., Paulinia, S?o Paulo, CEP 13140-970, Brazil

Manufactured for: Merial Limited, Operational Headquarters, 3239 Satellite Blvd., Duluth, GA 30096-4640, U.S.A.

PRINCIPAL DISPLAY PANEL - 6.08 g label

Product 70961
For Oral Use in Horses Only

Zimecterin®
(ivermectin) 1.87% Paste

Anthelmintic and Boticide

For Treatment of Large Strongyles, Small Strongyles,
Pinworms, Roundworms (Ascarids), Hairworms,
Neck Threadworms, Large-mouth Stomach Worms,
Bots. See carton for complete indications and use
directions. Consult your veterinarian for assistance in
the diagnosis, treatment and control of parasitism.

NADA 134-314, Approved by the FDA
U.S. Pat. 4,199,569

Net Wt. 0.21 oz (6.08 g)

MERIAL

PRINCIPAL DISPLAY PANEL - 6.08 g box

Zimecterin®
(ivermectin) 1.87% Paste
ANTHELMINTIC AND BOTICIDE

MERIAL

CONTENTS WILL TREAT UP TO 1250 lb BODY WEIGHT.

Removes worms and bots
with a single dose.
For Oral Use in Horses Only
NADA 134-314, Approved by FDA

Net Wt. 0.21 oz (6.08 g)


Zimecterin 
ivermectin  paste Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50604-7096 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (ivermectin) ivermectin 18.7 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 50604-7096-1 6.08 g In 1 SYRINGE, PLASTIC None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA134314 06/15/1984
Labeler - Merial Limited (034393582) Revised: 10/2009Merial Limited

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Tetradure



Dosage Form: FOR ANIMAL USE ONLY
Tetradure™
300
(OXYTETRACYCLINE) INJECTION

ANTIBIOTIC

Each mL contains 300 mg of oxytetracycline base as amphoteric oxytetracycline.

For Use in Beef Cattle, Non-lactating Dairy Cattle, Calves, Including Pre-ruminating (Veal) Calves and Swine.

READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT.

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

INTRODUCTION

Tetradure™ 300 (Oxytetracycline) Injection is a sterile, ready to use solution of the broad-spectrum antibiotic oxytetracycline dihydrate. Oxytetracycline is an antimicrobial agent that is effective in treatment of a wide range of diseases caused by susceptible gram-positive and gram-negative bacteria.

Tetradure™ 300 should be stored at room temperature 59°-86°F (15°-30°C). The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum or exudates.

INGREDIENTS

Tetradure™ 300 (oxytetracycline) Injection is a sterile, pre-constituted solution of the broad-spectrum antibiotic oxytetracycline dihydrate. Each mL contains 300 mg oxytetracycline as base, 40% (v/v) glycerol formal, 10% (v/v) polyethylene glycol 200, 2.7% (w/v) magnesium oxide, 0.4% (w/v) sodium formaldehyde sulphoxylate (as a preservative) and monoethanolamine (as required to adjust pH).

INDICATIONS

Tetradure™ 300 is intended for use in treatment for the following disease when due to oxytetracycline-susceptible organisms:

Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves

Tetradure™ 300 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., and Histophilus spp. Tetradure™ 300 is indicated for the treatment of the infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis, foot-rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococcal and streptococcal organisms sensitive to oxytetracycline. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica.

Swine

Tetradure™ 300 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona.

In sows Tetradure™ 300 is indicated as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

PHARMACOLOGY

Oxytetracycline is derived from the metabolic activity of the actinomycete, Streptomyces rimosus. Oxytetracycline is an antimicrobial agent that is effective in the treatment of a wide range of diseases caused by susceptible gram-positive and gram-negative bacteria.

The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum or exudates.

Studies have shown that the half-life of oxytetracycline in blood following intramuscular treatment with Tetradure™ 300 at 5 mg per pound of bodyweight is approximately 23 hours in cattle and 18 hours in swine.

Studies have shown when Tetradure™ 300 is administered once intramuscularly to cattle or swine at 9 mg per pound of bodyweight, blood oxytetracycline concentration of greater than 0.2 mcg/mL have been observed for 3 to 4 days.

Studies have shown when Tetradure™ 300 is administered once intramuscularly or subcutaneously to cattle at 13.6 mg per pound of bodyweight, blood oxytetracycline concentration of greater than 0.2 mcg/mL have been observed for at least 7 to 8 days.

Tetradure Dosage and Administration Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves

A single intramuscular or subcutaneous dosage of 13.6 mg of oxytetracycline per pound of bodyweight, Tetradure™ 300 is recommended for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica.

At a single intramuscular or subcutaneous dose range of 9 to 13.6 mg of oxytetracycline per pound of bodyweight, Tetradure™ 300 is recommended in the treatment of the following conditions:

(1) Bacterial pneumonia caused by Pasteurella spp (shipping fever) in calves and yearlings where retreatment is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable. (2) Infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis.

For other indications Tetradure™ 300 is to be administered intramuscularly, subcutaneously or intravenously at a level of 3 to 5 mg of oxytetracycline per pound of bodyweight per day. In treatment of foot-rot and advanced cases of other indicated diseases, a dosage level of 5 mg per pound of bodyweight per day is recommended. Treatment should be continued 24 to 48 hours following remission of disease signs, however, not to exceed a total of four (4) consecutive days. If improvement is not noted within 24 to 48 hours of the beginning of treatment, diagnosis and therapy should be re-evaluated.

Do not administer intramuscularly in the neck of small calves due to lack of sufficient muscle mass.

Use extreme care when administering this product by intravenous injection. Perivascular injection or leakage from an intravenous injection may cause severe swelling at the injection site.

Swine

A single dosage of 9 mg of oxytetracycline per pound of bodyweight administered intramuscularly is recommended in the treatment of bacterial pneumonia caused by Pasteurella multocida in swine, where retreatment is impractical due to husbandry conditions or where repeated restraint is inadvisable.

Tetradure™ 300 can also be administered by intramuscular injection at a level of 3 to 5 mg of oxytetracycline per pound of bodyweight per day. Treatment should be continued 24 to 48 hours following remission of disease signs; however, not to exceed a total of four (4) consecutive days. If improvement is not noted within 24 to 48 hours of the beginning of treatment, diagnosis and therapy should be re-evaluated.

For sows, administer once intramuscularly 3 mg of oxytetracycline per pound of bodyweight approximately eight (8) hours before farrowing or immediately after completion of farrowing as an aid in the control of infectious enteritis in baby pigs.

For swine weighing 25 lbs of bodyweight and under, Tetradure™ 300 should be administered undiluted for treatment at 9 mg/lb but should be administered diluted for treatment at 3 or 5 mg/lb.

9 mg dosage of undiluted Tetradure™ 300 3 or 5 mg/lb dosage volume of diluted Tetradure™ 300 Bodyweight 9 mg/lb 3 mg/lb Dilution* 5 mg/lb * To prepare dilutions, add one part of Tetradure™ 300 to three (3), five (5) or seven (7) parts of the sterile water, or 5% dextrose solution as indicated; the diluted product should be used immediately. 5 lb 0.15 mL 0.4 mL 37.5 mg/mL 0.7 mL 10 lb 0.30 mL 0.6 mL 50 mg/mL 1.0 mL 25 lb 0.75 mL 1.0 mL 75 mg/mL 1.7 mL Precautions

Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site in adult beef cattle and non-lactating dairy cattle and 5 mL intramuscularly per injection site in adult swine, may result in antibiotic residues beyond the withdrawal time.

Consult with your veterinarian prior to administering this product in order to determine to proper treatment required in the event of an adverse reaction. At the first sign of any adverse reaction, discontinue use of the product and seek the advice of your veterinarian. Some of the reactions may be attributable either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

Shortly after injection treated animals may have transient hemoglobinuria resulting in darkened urine.

As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. The absence of a favourable response following treatment, or the development of new signs or symptoms may suggest an overgrowth of non-susceptible organisms. If superinfections occur, the use of this product should be discontinued and appropriate specific therapy should be instituted.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Tetradure™ 300 in conjunction with penicillin.

STORAGE

Store at room temperature, 59°-86°F (15°-30°C). Keep from freezing.

Warnings

WARNINGS: Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Not for use in lactating dairy animals. Rapid intravenous administration may result in animal collapse. Oxytetracycline should be administered intravenous slowly over a period of at least 5 minutes.

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.

CAUTION

Intramuscular or subcutaneous injection may result in local tissue reactions which persist beyond the slaughter withdrawal period. This may result in trim loss of edible tissue at slaughter.

Intramuscular injection in the rump area may cause mild temporary lameness associated with swelling at the injection site. Subcutaneous injection in the neck area may cause swelling at the injection site.

Adverse Reactions

Reports of adverse reactions associated with oxytetracycline administration include injection site swelling, restlessness, ataxia, trembling, swelling of eyelids, ears, muzzle, anus and vulva (or scrotum and sheath in males), respiratory abnormalities (labored breathing), frothing at the mouth, collapse and possibly death. Some of these reactions may be attributed either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

PRESENTATION

Tetradure™ 300 is available in 100 mL, 250 mL and 500 mL vials.

Livestock Drug - Not for Human Use.
Restricted Drug(s) California. Use Only as Directed.

DISTRIBUTED BY:
Merial Limited
Duluth, GA 30096-4640, USA

™Tetradure is a trademark and Cattle Head Logo is a registered trademark of Merial Limited.
MADE IN THE UK

U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053

Rev. 06-2003

008630109

NADA 141-143, APPROVED BY THE FDA

PRINCIPAL DISPLAY PANEL - 100 mL Carton

Tetradure™
300

(OXYTETRACYCLINE) INJECTION

ANTIBIOTIC

Each mL contains 300 mg of Oxytetracycline
base as amphoteric oxytetracycline.

For the treatment of diseases in beef cattle,
non-lactating dairy cattle, calves, including
pre-ruminating (veal) calves and swine.

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

NADA 141-143, Approved By FDA

U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053

Net Contents:
100 mL

MERIAL


Tetradure 300 
oxytetracycline  injection, solution Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 50604-0415 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength oxytetracycline (oxytetracycline) oxytetracycline 300 mg  in 1 mL Inactive Ingredients Ingredient Name Strength glycerol formal   polyethylene glycol   magnesium oxide   sodium formaldehyde sulfoxylate   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 50604-0415-1 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 1 100 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-1) 2 50604-0415-2 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 2 250 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-2) 3 50604-0415-3 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 3 500 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-3)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141143 07/31/1993
Labeler - Merial Limited (034393582) Revised: 09/2010Merial Limited
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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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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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FML


fluorometholone
Dosage Form: ophthalmic suspension
FML®
(fluorometholone ophthalmic suspension, USP) 0.1%

Sterile

DESCRIPTION

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name:

Fluorometholone: 9-Fluoro-11?,17-dihydroxy-6?-methylpregna-1,4-diene-3,20-dione.

Structural Formula:

Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust the pH. FML® suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.

CLINICAL PHARMACOLOGY

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of documented steroid-responders, fluorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. The ultimate magnitude of the rise was equivalent for both drugs.

INDICATIONS AND USAGE

FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

CONTRAINDICATIONS

FML® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. FML® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

Corticosteroids are not effective in mustard gas keratitis and Sj?gren's keratoconjunctivitis.

PRECAUTIONS General:

The initial prescription and renewal of the medication order beyond 20 milliliters of FML® suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

Information for Patients:

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

The preservative in FML® suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling FML® suspension to insert soft contact lenses.

Carcinogenesis, mutagenesis, impairment of fertility:

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

Pregnancy:

Teratogenic effects. Pregnancy Category C: Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in infants below the age of 2 years have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.

Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS).

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of FML® suspension. Other adverse events reported with the use of FML® suspension include: allergic reactions, visual disturbance (blurry vision), and taste perversion.

DOSAGE AND ADMINISTRATION

Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

The dosing of FML® suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

HOW SUPPLIED

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

     5mL in 10mL bottle NDC 11980-211-05
   10mL in 15mL bottle NDC 11980-211-10
   15mL in 15mL bottle NDC 11980-211-15

Note: Store between 2° and 25°C (36° - 77°F); protect from freezing. Shake well before using.
Rx Only

Revised June 2003


©2003 Allergan, Inc.
Irvine, CA 92612, U.S.A. 4708X
® Marks owned by Allergan, Inc. 71598US10M

ALLERGAN

NDC 11980-211-15

Rx Only

FML®

(fluorometholone

ophthalmic suspension,

USP) 0.1%

15 mL sterile

ALLERGAN

NDC 11980-211-15 Rx Only

FML®

(fluorometholone

ophthalmic suspension,

USP) 0.1%

15 mL sterile


FML 
fluorometholone  suspension/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 11980-211 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fluorometholone (fluorometholone) fluorometholone 1 mg  in 1 mL Inactive Ingredients Ingredient Name Strength benzalkonium chloride   edetate disodium   polysorbate 80   polyvinyl alcohol   water   sodium chloride   sodium phosphate, dibasic   sodium phosphate, monobasic   sodium hydroxide   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 11980-211-05 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (11980-211-05) 2 11980-211-10 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 2 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (11980-211-10) 3 11980-211-15 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 3 15 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (11980-211-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA016851 02/01/1972
Labeler - Allergan, Inc. (144796497) Establishment Name Address ID/FEI Operations Allergan, Inc. 362898611 MANUFACTURE Revised: 10/2010Allergan, Inc. More FML resources FML Side Effects (in more detail) FML Dosage FML Use in Pregnancy & Breastfeeding FML Drug Interactions 0 Reviews for FML - Add your own review/rating Compare FML with other medications Eye Dryness/Redness Eye Redness/Itching Eyelash Hypotrichosis
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Lamisil AT 1% Spray


1. Name Of The Medicinal Product

Lamisil® AT 1% Spray

2. Qualitative And Quantitative Composition

10mg terbinafine hydrochloride per 1g spray solution

For excipients, see Section 6.1.

3. Pharmaceutical Form

Cutaneous spray, solution

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of tinea pedis (athlete's foot) and tinea cruris, (dhobie (jock) itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

4.2 Posology And Method Of Administration

Adults

Lamisil AT 1% Spray is applied once daily, for one week. Cleanse and dry the affected areas thoroughly before applying Lamisil AT 1% Spray from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area.

Duration and frequency of treatment:

Interdigital type tinea pedis, and tinea cruris: Once a day for one week.

Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, a physician should be consulted.

Use of Lamisil AT 1% Spray in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.

Use of Lamisil AT 1% Spray in children

Not to be used in children under 16 years of age. Experience with Lamisil AT 1% Spray in children is limited and its use cannot, therefore, be recommended.

4.3 Contraindications

Known hypersensitivity to terbinafine or any of the excipients contained in the spray solution (see 6.1 List of excipients).

4.4 Special Warnings And Precautions For Use

Lamisil AT 1% Spray should be used with caution in patients with lesions where alcohol could be irritating.

Lamisil AT 1% Spray is for external use only. It may be irritating to the eyes. Lamisil AT 1% Spray should not be used on the face.

In case of accidental contact with the eyes, rinse eyes thoroughly with running water.

Avoid inhalation. In case of accidental inhalation, consult a physician if any symptoms develop or persist.

Lamisil AT 1% Spray should be kept out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No drug interactions are known with Lamisil AT 1% Spray, however as a precaution it is recommended that other medicinal products are not applied on the treated areas.

4.6 Pregnancy And Lactation

Animal studies did not reveal any teratogenic or embryofoetotoxic potential of terbinafine. No cases of malformations in humans have been reported with Lamisil to date. However, since clinical experience in pregnant women is very limited, Lamisil AT 1% Spray should be used only if clearly indicated during pregnancy. Terbinafine is excreted in breast milk and therefore, mothers should not receive Lamisil AT 1% Spray whilst breast-feeding. Infants should also not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Redness, itching or stinging may occur at the site of application; however, treatment rarely has to be discontinued for this reason. These harmless symptoms must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives, which are rare but require discontinuation.

4.9 Overdose

No case of overdosage has been reported with Lamisil AT 1% Spray. Should, however, Lamisil AT 1% Spray be inadvertently ingested, adverse effects similar to those observed with an overdosage of Lamisil Tablets (e.g. headache, nausea, epigastric pain and dizziness) are to be expected. The alcohol content (23.5%) of the spray solution has to be taken into account.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01 A)

Terbinafine is an allylamine which has a broad spectrum of antifungal activity in fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. At low concentrations terbinafine is fungicidal against dermatophytes and moulds. The activity against yeasts is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

5.2 Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application to humans; systemic exposure is thus very slight.

5.3 Preclinical Safety Data

In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100mg/kg a day. At high oral doses, the liver and possibly also the kidneys were identified as potential target organs.

In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69mg/kg a day, an increased incidence of liver tumours was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys.

During the studies of high dose oral terbinafine in monkeys, refractile irregularities were observed in the retina at the higher doses (non-toxic effect level was 50mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in ocular tissue and disappeared after drug discontinuation. They were not associated with histological changes.

A standard battery of in vitro and in vivo genotoxicity tests revealed no evidence of a mutagenic or clastogenic potential for the drug.

No adverse effects on fertility or other reproduction parameters were observed in studies in rats or rabbits.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified water

Ethanol (23.5% w/w)

Propylene glycol

Cetomacrogol 1000

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 30°C. Do not refrigerate.

6.5 Nature And Contents Of Container

Lamisil AT 1% Spray is available as a white round HDPE bottle with a crimped mouth and spray pump in pack sizes of 15ml and 30ml.

6.6 Special Precautions For Disposal And Other Handling

See 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use.

For manipulation of the spray pump the bottle can be held in the upright or inverted position.

When using Lamisil AT 1% Spray for the first time, the patient will need to depress the actuator a few times (usually up to 3 actuations) before the solution is dispensed.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd.

Wimblehurst Road

Horsham

RH12 5AB

UK

Trading as Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0147

9. Date Of First Authorisation/Renewal Of The Authorisation

7th December 2001

10. Date Of Revision Of The Text

27th April 2009

Legal Category: GSL


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Anthralin Cream


Pronunciation: AN-thrah-lin
Generic Name: Anthralin
Brand Name: Examples include Dritho-Scalp and Zithronal RR
Anthralin Cream is used for:

Treating psoriasis.

Anthralin Cream is a topical antimitotic. It works by slowing the reproduction of skin cells.

Do NOT use Anthralin Cream if: you are allergic to any ingredient in Anthralin Cream you have active inflamed psoriatic eruptions

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

Before using Anthralin Cream:

Some medical conditions may interact with Anthralin 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 inflamed psoriatic eruptions, folliculitis, other skin problems, or kidney disease

Some MEDICINES MAY INTERACT with Anthralin Cream. Because little, if any, of Anthralin Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

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

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

Anthralin Cream is for external use only. Avoid contact with the eyes, nose, and mouth. Do not apply to folds or creases of the skin. Wash and completely dry the affected area. Apply a small amount onto the lesions and rub it in gently and carefully. At the end of each skin treatment period, rinse the skin completely with cool to lukewarm water before washing it with soap. The margins of lesions may gradually become stained (purple/brown) as you continue to use Anthralin Cream, but the staining will disappear after your treatment is finished. For scalp treatment, wash your hair before applying Anthralin Cream. Rinse your hair with water, and comb it to remove scaling. Apply Anthralin Cream while your scalp is still damp. Rub the medicine into the lesions well. Do not apply Anthralin Cream to areas where there are no lesions. Remove any medicine that may be behind the ears. At the end of each scalp treatment period, rinse your hair and scalp completely with cool to lukewarm water. Shampoo your hair and scalp to remove any additional cream (which may have become red/brown). Wash your hands immediately after using Anthralin Cream, unless your hands are part of the treated area. If excessive soreness or spreading of lesions occurs after using Anthralin Cream, contact your health care provider. If you miss a dose of Anthralin 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 Anthralin Cream.

Important safety information: Anthralin Cream may be harmful if swallowed. If you may have taken Anthralin Cream by mouth, contact your local poison control center or emergency room immediately. Anthralin Cream may stain skin or hair. Temporary discoloration of hair and fingernails may occur while using Anthralin Cream, but can be minimized by carefully applying the medicine. To prevent discoloration of the tub or shower, always rinse the tub or shower with lukewarm water right after washing or showering. Use a cleanser to remove any deposit on the surface of the tub or shower. Use protective dressings while using Anthralin Cream to prevent staining of clothing and bed sheets unless instructed otherwise by your doctor. Staining of fabric may be permanent. Contact with plastics and other materials may cause staining and should be avoided. Use Anthralin Cream with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Anthralin Cream, discuss with your doctor the benefits and risks of using Anthralin Cream during pregnancy. It is unknown if Anthralin Cream is excreted in breast milk. Do not breast-feed while taking Anthralin Cream. Possible side effects of Anthralin 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:

Irritation; staining of treated areas.

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); severe skin soreness; spreading of lesions.

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: Anthralin 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 Anthralin Cream:

Store Anthralin Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anthralin Cream out of the reach of children and away from pets.

General information: If you have any questions about Anthralin Cream, please talk with your doctor, pharmacist, or other health care provider. Anthralin 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 Anthralin 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 Anthralin resources Anthralin Side Effects (in more detail) Anthralin Use in Pregnancy & Breastfeeding Anthralin Support Group 0 Reviews for Anthralin - Add your own review/rating Compare Anthralin with other medications Psoriasis
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Vet One Chlorhexidine



Dosage Form: FOR ANIMAL USE ONLY
MWI/Vet One 2% Chlorhexidine solution MWI/Vet One 2% Chlorhexidine solution

ACTIVE INGREDIENTS:
2% Chlorhexidine Gluconate.

CAUTION:
Avoid contact with eyes and mucous membranes. This product is not to be used in ears. If contact is made, flush immediately and thoroughly with clean water. For use on horses and dogs.

Product No. 1CHL008
8CHL008-108
Distributed by:
MWI
Meridian, ID 83680
(888) 694-8381
MWI/Vet One 2% Chlorhexidine solution

PRODUCT DESCRIPION:
A topical aqueous cleaning solution for use on horses and dogs for application to superficial cuts, abrasions or insect stings.

DILUTE:
1 ounce (2 tablespoons) of Chlorhexidine Solution per gallon of clean water.
DIRECTIONS FOR USE:
Rinse skin area to be treated with Chlorhexidine Solution. Wipe away excess and pat dry with sterilized gauze or sponge.
MWI/Vet One 2% Chlorhexidine solution


Vet One Chlorhexidine 
chlorhexidine gluconate  solution Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 13985-017 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (CHLORHEXIDINE) Chlorhexidine Gluconate 2 g  in 0.1 L Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 13985-017-80 3.785 L In 1 JUG None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2010
Labeler - MWI VETERINARY SUPPLY CO (019926120) Revised: 01/2010MWI VETERINARY SUPPLY CO

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