Label: FLUNAZINE- flunixin meglumine paste
- NDC Code(s): 61133-6007-1
- Packager: Bimeda Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated November 28, 2018
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WARNINGS AND PRECAUTIONS
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.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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.
INDICATIONS & USAGE
INDICATIONS: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
DOSE: 0.5 mg per pound of body weight per day for up to 5 days. Each calibration on the syringe' doses 250 lbs of body weight. Administer orally 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. *Use dial edge nearest syringe barrel to mark dose.
ACTIVITY: Flunixin meglumine is a potent, nonnarcotic, nonsteroidal , analgesic agent with 1 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 1 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.
- STORAGE AND HANDLING
DOSAGE & ADMINISTRATION
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.
Syringe Mark* Horse Weight (lbs) Flunazine® Equine Paste Delevered (g) mg Flunixin Delivered 0 --- --- --- 250 250 2.5 125 500 500 5.0 250 750 750 7.5 375 1000 1000 10.0 500
* 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.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
flunixin meglumine paste
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61133-6007 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUNIXIN MEGLUMINE (UNII: 8Y3JK0JW3U) (FLUNIXIN - UNII:356IB1O400) FLUNIXIN MEGLUMINE 1500 mg in 30 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-6007-1 30 g in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200581 02/26/2015 Labeler - Bimeda Inc. (060492923) Registrant - Bimeda Inc. (060492923) Establishment Name Address ID/FEI Business Operations Bimeda-MTC Animal Health 256232216 manufacture