BANAMINE (FLUNIXIN MEGLUMINE) PASTE [MERCK SHARP & DOHME CORP.]

BANAMINE (FLUNIXIN MEGLUMINE) PASTE [MERCK SHARP & DOHME CORP.]
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NDC 0061-0214-02
Set ID 26d5eb1e-e9f3-4c3f-abb2-fe432cf09353
Category PRESCRIPTION ANIMAL DRUG LABEL
Packager Merck Sharp & Dohme Corp.
Generic Name
Product Class
Product Number
Application Number NADA137409
  • 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
    2502502.5125
    5005005.0250
    7507507.5375
    1000100010.0500

    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

    PRINCIPAL DISPLAY PANEL - 1500 mg Syringe Label
  • INGREDIENTS AND APPEARANCE
    BANAMINE 
    flunixin meglumine paste
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0061-0214
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Flunixin Meglumine (UNII: 8Y3JK0JW3U) (Flunixin - UNII:356IB1O400) Flunixin1500 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Carboxymethylcellulose (UNII: 05JZI7B19X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0061-0214-0230 g in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA13740911/11/2011
    Labeler - Merck Sharp & Dohme Corp. (001317601)

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