Amprolium

Teva Animal Health, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Indications
• Warnings:
• Residue Warning
• Precautions
• Dosage and Administration
• Inactive ingredients
• Storage
• Package/Label Principal Display Panel
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient: amprolium ………………………9.6%

Indications

INDICATIONS: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves. For a satisfactory diagnosis a microscopic examination of the feces should be done before treatment. When treating outbreaks, drug should be administered promptly after diagnosis is determined.

Warnings:

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 reactions in users, to obtain more information, or to obtain a MSDS, contact Teva Animal Health at 1-800-759-3664.

Residue Warning

RESIDUE WARNING: Withdraw 24 hours before slaughter. 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

PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention. 

Restricted Drug (California)-Use Only As Directed.

Dosage and Administration

DOSAGE AND ADMINISTRATION:

5-Day Treatment Protocol

Daily Dosage: 10mg amprolium/kg

(10mg per 2.2 lb. body weight)

21-Day Prevention Protocol

Daily Dosage: 5 mg amprolium/kg

(5 mg per 2.2 lb body weight)

USE DIRECTIONS: There are 96 mg of amprolium in every 1 mL of Amprolium 9.6% Oral Solution.

1 fl oz= 29.57mL

1 fl oz = 2 measuring tablespoonfuls

8 fl oz = ½ pint (236.56mL)

16 fl oz = 1 pint (473.12mL)

IN DRINKING WATER

Mix Amprolium 9.6% Oral Solution daily with fresh drinking water.

5-DAY TREATMENT: Add Amprolium 9.6% Oral Solution to drinking water at the rate of 16 fl oz/100 gal. At the usual rate of water consumption this will provide an intake of approximately 10 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 5 days. Use on a herd basis only; When one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated.

21-DAY TREATMENT: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add Amprolium 9.6% Oral Solution to drinking water at the rate of 8 fl oz/100 gal. At usual rates of water consumption this will provide an intake of approximately 5 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 21 days.

AS A DRENCH

Amprolium 9.6% Oral Solution drench solutions may be stored in a clean, closed, labeled container for up to 3 days.

5-DAY TREATMENT: Add 3 fl oz Amprolium 9.6% Oral Solution to 1 pt of water and, with a dose syringe, give 1 fl oz of this drench solution for each 100 lb (45kg) body weight. This will provide a dose of approximately 10 mg amprolium/kg (2.2 lb) body weight. Give daily for 5 days. Use on a herd basis only; When one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated.

21-DAY TREATMENT: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 ½ fl oz of Amprolium 9.6% Oral Solution to 1 pt of water and, with a dose syringe, give 1 fl oz of this drench solution for each 100 lb (45kg) body weight. This will provide a dose of approximately 5 mg amprolium/kg (2.2 lb) body weight. Give daily for 21 days. .

Inactive ingredients

Inactive Ingredients: Benzoic Acid, Purified Water, Hydrochloric Acid, Sodium Hydroxide

Storage

Store at controlled room temperature 20°-25°-C (68°-77°-F).

Benzoic acid 0.1% added as preservative

Technical Assistance: 1-800-759-3664.

Package/Label Principal Display Panel

Package/Label Principal Display Panel