Your browser does not support JavaScript! AMPROMED FOR CALVES (AMPROLIUM) POWDER [BIMEDA, INC., DIVISION OF CROSS VETPHARM GROUP]

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AMPROMED FOR CALVES (amprolium) powder
[Bimeda, Inc., Division of Cross Vetpharm Group]


Category DEA Schedule Marketing Status
OTC ANIMAL DRUG LABEL Abbreviated New Animal Drug Application
Drug Label Sections

AmproMed™ FOR CALVES 

(amprolium)

20% Soluble Powder

Coccidiostat´╗┐

FOR ANIMAL USE ONLY

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN


Restricted Drug (California) – Use Only as Directed

ANADA 200-464, Approved by FDA


INDICATION: An Aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves.

Net Contents:

25 lb (11.34 kg)

ACTIVE INGREDIENT: amprolium..............20%

Use Directions: There are 220 mg of amprolium in every 1 gram of AMPROMED FOR CALVES

 5-Day Treatment Protocol21-Day Prevention Protocol 

Daily Dosage: 10 mg amprolium/kg

(10 mg per 2.2 lb body weight)

Daily Dosage: 10 mg amprolium/kg

(10 mg per 2.2 lb body weight)

 1 oz=3 1/2 measuring tablespoonfuls 1 oz=28.35 grams

In Drinking Water: Mix AMPROMED FOR CALVES daily with fresh drinking water. Stock solution for water proportioners may be stored in a clean, closed, labeled container for up to 3 days.

5-DAY TREATMENT: Add AMPROMED FOR CALVES to drinking water at the rate of 4 oz/50 gallon. One 10 oz pack to 125 gallons of water. For use in automatic water proportioners that meter 1 fl oz of stock solution per gallon of drinking water, add 1 pouch (10 oz) in 1 gallon of water to make stock solution. 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. Treatment should be 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 AMPROMED FOR CALVES to drinking water at the rate of 4 oz/100 gallon. One 10 oz pack to 250 gallons of water. For use in automatic water proportioners that meter 1 fl oz of stock solution per gallon of drinking water, add 1/2 pouch (5 oz) in 1 gallon of water to make stock solution. 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 oz AMPROMED FOR CALVES to 1 qt (32 fl oz) of water and, with a dosage syringe, give 1 fl oz of this 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. Treatment should be 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 TREATMENT: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 1/2 oz AMPROMED FOR CALVES to 1 qt (32 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.

CAUTION: 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.

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.

STORAGE: Store at 20°C - 25°C (68°F - 77°F), excursions permitted between 15°C - 30°C (59°F - 86°F),

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 MSDS contact Bimeda, Inc. at 1-888-524-6332.

HOW SUPPLIED: 10 oz Pouches and 25 lb Pail.

image description

AMPROMED FOR CALVES 
amprolium powder
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:61133-8250
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMPROLIUM (AMPROLIUM ION) AMPROLIUM ION220 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61133-8250-1283.5 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20046405/23/2011
Labeler - Bimeda, Inc., Division of Cross Vetpharm Group (060492923)
Registrant - Bimeda, Inc., Division of Cross Vetpharm Group (060492923)
Establishment
NameAddressID/FEIBusiness Operations
Bimeda, Inc., Division of Cross Vetpharm Group060492923manufacture
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Jiuzhou654682061api manufacture

Revised: 7/2013
 
Bimeda, Inc., Division of Cross Vetpharm Group

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