BANAMINE- flunixin meglumine paste

Banamine by

Drug Labeling and Warnings

Banamine by is a Animal medication manufactured, distributed, or labeled by Merck Sharp & Dohme Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Paste –1500 mg
flunixin/syringe
Veterinary

For Oral Use in Horses Only

PRODUCT
INFORMATION

WARNINGS

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

DESCRIPTION

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

VETERINARY INDICATIONS

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

SPL UNCLASSIFIED SECTION

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

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

FOOD SAFETY WARNING

WARNING Do not use in horses intended for human consumption.

PRECAUTIONS

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.

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION

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.

DOSAGE TABLE

Syringe Mark*	Horse Weight (lbs)	BANAMINE Paste Delivered (g)	Mg Flunixin Delivered
* Use dial edge nearest syringe barrel to mark dose.
0	—	—	—
250	250	2.5	125
500	500	5.0	250
750	750	7.5	375
1000	1000	10.0	500

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.

SPL UNCLASSIFIED SECTION

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

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

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

SPL UNCLASSIFIED SECTION

For patent information: http://www.merck.com/product/patent/home.html

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)
Paste

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

MERCK
Animal Health

INGREDIENTS AND APPEARANCE

BANAMINE 
flunixin meglumine paste

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 0061-0214
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Flunixin Meglumine (UNII: 8Y3JK0JW3U) (Flunixin - UNII:356IB1O400)	Flunixin	1500 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Starch, Corn (UNII: O8232NY3SJ)
Propylene Glycol (UNII: 6DC9Q167V3)
Carboxymethylcellulose (UNII: 05JZI7B19X)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0061-0214-02	30 g in 1 SYRINGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA137409	11/11/2011

Labeler - Merck Sharp & Dohme Corp. (001317601)