Banamine Granules

Manufacturer: Intervet/Schering-Plough Animal Health

(flunixin Meglumine)

Granules - 250 Mg & 500 Mg

Veterinary

For Oral Use In Horses Only

Nada #106-616, Approved By Fda.

Banamine Granules Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Each 10-gram packet of BANAMINE Granules contains flunixin meglumine equivalent to 250 mg flunixin and each 20- gram packet of BANAMINE Granules contains flunixin meglumine equivalent to 500 mg flunixin.

Pharmacology

Flunixin meglumine is a potent non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine or codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show the onset of flunixin activity occurs within two hours of administration. Peak response occurs between 12 and 16 hours and the duration of activity is 24 to 36 hours.

Banamine Granules Indications

BANAMINE Granules are recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

Warning

Not for use in horses intended for food.

Precautions

The effect of BANAMINE Granules on pregnancy has not been determined. Studies to date show that there is not a detrimental effect on stallion spermatogenesis with or following the recommended dose of BANAMINE Granules.

Contraindications

There are no known contraindications to this drug when used as directed.

Toxicity

No toxic effects were observed in rats given oral flunixin 2 mg/kg per day for 42 days. Higher doses produced ulceration of the gastro-intestinal tract. The emetic dose in dogs is between 150 and 250 mg/kg. Flunixin was well tolerated in monkeys dosed daily with 4 mg/kg for 56 days. No adverse effects occurred in horses dosed orally with 1.0 or 1.5 mg/lb for 15 consecutive days.

Side Effects

During clinical studies, no significant side effects were reported.

Banamine Granules Dosage And Administration

The recommended dose of flunixin is 0.5 mg per pound of body weight daily; i.e. one 10-gram packet treats 500 pounds and one 20-gram packet treats 1000 pounds. The granules are easily administered by sprinkling on a small amount of feed. Treatment may be given initially by intravenous or intramuscular injection of BANAMINE Solution, followed by BANAMINE Granules on days 2 to 5. BANAMINE treatment should not exceed 5 consecutive days.

Store Between 2° And 30°c (36° And 86°f).

How Supplied

BANAMINE Granules, 250 mg are available in 10-gram packets, box of 50 (NDC 0061-0255-02) and BANAMINE Granules, 500 mg are available in 20-gram packets, box of 25 (NDC 0061-0255-03).

JANUARY 2001

Packaged for: Schering-Plough Animal Health Corp., Union, New Jersey 07083.

Made in Ireland.

Copyright © 1978, 1985, 1988, 1989, Schering-Plough Animal Health.

All rights reserved.

24250806

Nac No.

10470171