AMPROMED FOR CALVES- amprolium solution

AmproMed FOR CALVES by

Drug Labeling and Warnings

AmproMed FOR CALVES by is a Animal medication manufactured, distributed, or labeled by Bimeda Inc., Bimeda, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

AmproMed™ FOR CALVES

(amprolium)

9.6% Oral Solution

Coccidiostat

FOR ORAL USE IN ANIMALS ONLY

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

Restricted Drug (California) – Use Only as Directed

ANADA 200-482, Approved by FDA

Net Contents:

1 Gallon (128 fl oz) (3.785 L)

ACTIVE INGREDIENT: amprolium..............9.6%

INDICATIONS: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zuernii 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.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION:

USE DIRECTIONS: There are 96 mg of Amprolium in every 1 mL of AmproMed™ FOR CALVES

• 5 Day Treatment Protocol: 21 Day Prevention Protocol
• Daily Dosage: 10 mg amprolium/kg (10 mg per 2.2 lb body weight) 1 fl oz = 29.57 mL 1 fl oz = 2 measuring tablespoonfuls:

  Daily Dosage: 5 mg amprolium/kg

  (5 mg per 2.2 lb body weight)

  8 fl oz = ½ pint (236.56 mL)

  16 fl oz = 1 pint (473.12 mL)

IN DRINKING WATER:

Mix AmproMed™ FOR CALVES daily with fresh drinking water.

5-DAY TREATMENT: Add AMPROMED™ FOR CALVES to drinking water at the rate of 16 fl oz/100 gallon. 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 PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add AMPROMED™ FOR CALVES to drinking water at the rate of 8 fl oz/100 gallon. 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: AMPROMED™ FOR CALVES drench solutions may be stored in a clean, labeled container for up to 3 days.

5-DAY TREATMENT: Add 3 fl oz AMPROMED™ FOR CALVES to 1 pt (16 oz) of water and, with a dosage syringe, give 1 fl oz of this drench solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 10 mg amprolium/kg (2.2) 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 should be treated.

21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 1/2 fl oz of AMPROMED™ FOR CALVES to 1 pt (16 fl oz) of water and, with a dose syringe, give 1 fl oz of this solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 5 mg amprolium/kg (2.2 lb) body weight. Give daily for 21 days.

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.

WARNINGS

WARNING: Not for Human Use. Keep this and all drugs out of reach of children.

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

PRECAUTIONS

PRECAUTIONS: MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention. Sodium Benzoate 0.1% add as preservative.

STORAGE AND HANDLING

STORAGE: Store container in an upright position. Store between 5°C - 25°C (41°F - 77°F), with brief excursions to 40°C.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMPROMED FOR CALVES 
amprolium solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 61133-8251
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR)	AMPROLIUM ION	96 mg  in 1 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-8251-3	3785 mL in 1 JUG
2	NDC: 61133-8251-4	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200482	07/30/2012

Labeler - Bimeda Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda, Inc.		060492923	manufacture