Banamine

Merck Sharp & Dohme Corp.

Banamine (FLUNIXIN MEGLUMINE)

FULL PRESCRIBING INFORMATION: CONTENTS*

• CAUTION
• BANAMINE DESCRIPTION
• INDICATIONS BANAMINE
• ACTIVITY
• BANAMINE CONTRAINDICATIONS
• WARNING
• PRECAUTIONS
• SIDE EFFECTS
• BANAMINE DOSAGE AND ADMINISTRATION
• TOXICITY
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label

FULL PRESCRIBING INFORMATION

Paste –1500 mg
flunixin/syringe
Veterinary

For Oral Use in Horses Only

PRODUCT INFORMATION

CAUTION

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

BANAMINE DESCRIPTION

Each 30-gram syringe of BANAMINE Paste contains flunixin meglumine equivalent to 1500 mg flunixin.

INDICATIONS BANAMINE

Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.

ACTIVITY

Flunixin meglumine is a potent, nonnarcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test. Oral studies in the horse show onset of flunixin activity occurs within 2 hours of administration. Peak response occurs between 12 and 16 hours and duration of activity is 24 to 36 hours.

BANAMINE CONTRAINDICATIONS

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

WARNING

Not for use in horses intended for human consumption.

PRECAUTIONS

The effect of BANAMINE Paste on pregnancy has not been determined. Studies to date show there is no detrimental effect on stallion spermatogenesis with or following the recommended dose of BANAMINE Paste.

SIDE EFFECTS

During field studies with BANAMINE Paste, no significant side effects were reported.

BANAMINE DOSAGE AND ADMINISTRATION

The recommended dose of flunixin is 0.5 mg per lb of body weight once daily. The BANAMINE Paste syringe, calibrated in twelve 250-lb weight increments, delivers 125 mg of flunixin for each 250 lbs (see dosage table). One syringe will treat a 1000-lb horse once daily for 3 days, or three 1000-lb horses one time.

The paste is orally administered by inserting the nozzle of the syringe through the interdental space, and depositing the required amount of paste on the back of the tongue by depressing the plunger.

Treatment may be given initially by intravenous or intramuscular injection of BANAMINE Solution, followed by BANAMINE Granules or BANAMINE Paste on Days 2 to 5. BANAMINE treatment should not exceed 5 consecutive days.

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 gastrointestinal 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 fifteen consecutive days.

HOW SUPPLIED

BANAMINE Paste, 1500 mg is available in a single 30-g syringe.

Store below 25°C (77°F). Do not Freeze.

U.S. Patent No. 5,484,931

PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label

Syringe contains flunixin
meglumine equivalent to
1500 mg
FLUNIXIN
Net Wt 30 g

NDC 0061-0214-02

Banamine ^®
(FLUNIXIN MEGLUMINE)
Paste

For oral use in horses only.
Warning: Not for use in horses intended
for human consumption.
Caution: Federal law restricts this drug to
use by or on the order
of a licensed veterinarian.
NADA #137-409, Approved by FDA.

MERCK
Animal Health