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Animal NDC 0061-0214-02 Banamine

Flunixin Meglumine

Animal Product Information

Field Name Field Value
Animal NDC Code 0061-0214-02
Proprietary Name Banamine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Flunixin Meglumine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Merck Sharp & Dohme Corp.
Product Type Prescription Animal Drug
Usage Information
    INDICATIONS BANAMINE Paste is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Active Ingredient(s)
  • Flunixin Meglumine
Inactive Ingredient(s)
  • STARCH, CORN (O8232NY3SJ)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • CARBOXYMETHYLCELLULOSE (05JZI7B19X)
  • WATER (059QF0KO0R)
  • STARCH, CORN (O8232NY3SJ)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • CARBOXYMETHYLCELLULOSE (05JZI7B19X)
  • WATER (059QF0KO0R)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA137409 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Banamine Images

Banamine Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Paste –1500 mg
flunixin/syringe
Veterinary

For Oral Use in Horses Only

PRODUCT
INFORMATION

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.

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

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.

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


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.


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.


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

Use dial edge nearest syringe barrel to mark dose.

Horse Weight (lbs)BANAMINE Paste Delivered (g)Mg Flunixin Delivered
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.


How Supplied



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


Storage And Handling



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


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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.