Flunazine Equine Paste

Company: Bimeda

(flunixin meglumine)

ANADA 200-581, Approved by FDA

SYRINGE CONTAINS FLUNIXIN MEGLUMINE EQUIVALENT TO 1500 mg FLUNIXIN

FOR ORAL USE IN HORSES ONLY

KEEP OUT OF REACH OF CHILDREN

Warning

Do not use in horses intended for human consumption.

Flunazine Equine Paste Caution

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

Flunazine Equine Paste Indications

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.

Contraindications

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

Precautions

The effect of flunixin meglumine 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 flunixin meglumine.

Side Effects

During field studies with flunixin meglumine, no significant side effects were reported.

Dosage and Administration

The recommended dose of flunixin meglumine is 0.5 mg per lb of body weight once daily. The Flunazine^® Equine 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.

DOSAGE TABLE

* Use dial edge nearest syringe barrel to mark dose.

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 Flunazine Injectable Solution, followed by Flunazine^® Equine Paste on Days 2 to 5. Flunixin meglumine treatment should not exceed 5 consecutive days.

TOXICITY: No toxic effects were observed in rats given oral flunixin meglumine 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 5 consecutive days.

Storage

Store at 20°C - 25°C (69°F - 77°F); excursions permitted between 15°C - 30°C (between 59°F - 86°F).

Apple Flavored

Flunazine^® is a Registered Trademark of Bimeda, Inc.

N.A. Corp. Address: Bimeda, Inc., One Tower Lane, Oakbrook Terrace, IL 60181

Manufactured by: Bimeda-MTC Animal Health Inc., Cambridge, ON Canada N3C 2W4

Manufactured for: Bimeda, Inc., Le Sueur, MN 56058

www.bimedaus.com

CPN: 1399114.1