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

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AMPROMED FOR CALVES (amprolium) solution
[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)

9.6% Oral Solution

Coccidiostat

FOR ORAL USE IN ANIMAL 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:

1Gallon (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 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: 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.

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

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

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AMPROMED FOR CALVES 
amprolium solution
Product Information
Product TypeOTC ANIMAL DRUG LABELItem Code (Source)NDC:61133-8251
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMPROLIUM (AMPROLIUM ION) AMPROLIUM ION96 mg  in 1 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61133-8251-33785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20048207/30/2012
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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