AMPROMED FOR CALVES- amprolium solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR)

Available from:

Bimeda Inc.

INN (International Name):

AMPROLIUM

Composition:

AMPROLIUM ION 96 mg in 1 mL

Administration route:

ORAL

Prescription type:

OTC

Therapeutic indications:

AmproMed™ FOR CALVES (amprolium) 9.6% Oral Solution Coccidiostat Restricted Drug (California) – Use Only as Directed Approved by FDA under ANADA # 200-482 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.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

AMPROMED FOR CALVES- AMPROLIUM SOLUTION
BIMEDA INC.
----------
AMPROMED™ FOR CALVES
(AMPROLIUM)
_9.6% ORAL SOLUTION COCCIDIOSTAT_
RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED
Approved by FDA under ANADA # 200-482
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 AND ADMINISTRATION: 5-DAY TREATMENT PROTOCOL 21-DAY PREVENTION PROTOCOL
Daily Dosage: 10 mg amprolium/kg
(10 mg per 2.2 lb body weight)
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 AmproMed
FOR
CALVES
1 fl oz = 29.57 mL
1 fl oz = 2 measuring tablespoons
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 9.6% Oral Solution 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 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: AMPROMED FOR CALVES drench solutions may be stored i