BANAMINE® TRANSDERMAL

(flunixin transdermal solution)

Product Description

BANAMINE® TRANSDERMAL (flunixin transdermal solution) for control of fever associated with bovine respiratory disease and acute bovine mastitis, and the control of pain associated with foot rot, is the first and only non-steroidal anti-inflammatory (NSAID) cattle product available with a convenient pour-on route of administration.

Indications

Banamine Transdermal pour-on is indicated for the control of pyrexia associated with bovine respiratory disease and acute bovine mastitis, and the control of pain associated with foot rot in beef cattle 2 months of age and older and dairy cattle.

Not for use in beef and dairy bulls intended for breeding over 1 year of age, replacement dairy heifers over 20 months of age, dry dairy cows, dairy calves, or veal calves.

Dosage

Apply only once at a dose of 3.3 mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically in a narrow strip along the dorsal midline from the withers to the tailhead. Round the dose up to the nearest weight increment on the dosing chamber. If pyrexia, or the pain associated with foot rot persists, the diagnosis should be re-evaluated and alternative therapy considered. Do not treat cattle if the hide is wet or may get wet in the six hours after dosing because effectiveness has not been evaluated under wet hide conditions.

Practice the Administration and Overfill Reduction Instructions a few times to become familiar with operating the package before dosing animals.

Contraindications

NSAIDs inhibit production of prostaglandins which are important in signaling the initiation of parturition. The use of flunixin can delay parturition and prolong labor which may increase the risk of stillbirth. Do not use Banamine Transdermal pour-on within 48 hours of expected parturition. Do not use in animals showing hypersensitivity to flunixin meglumine.

Supplied

100-mL bottles
250-mL bottles
1-L bottles

Storage

Store at or below 30°C (86°F). Use within 6 months of first opening.

Residue Warnings

Milk that has been taken during treatment and for 48 hours after treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days of treatment. Not for use in replacement dairy heifers 20 months of age or older or dry dairy cows; use in these cattle may cause drug residues in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Approved only as a single topical dose in cattle. Repeated treatments may result in violative residues in milk or in edible tissues.

Precautions

As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with renal, cardiovascular, and/or hepatic dysfunction. Banamine Transdermal should be used with caution in animals with suspected pre-existing gastric erosions or ulcerations. Concurrent administration of other NSAIDs, corticosteroids, or potentially nephrotoxic drugs should be avoided or used only with careful monitoring because of the potential increase of adverse events. Banamine Transdermal is approved only as a single topical dose. The safety of repeated treatment has not been evaluated.

NSAIDs are known to have potential effects on both parturition (see Contraindications) and the estrous cycle. There may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of the estrous cycle. NSAIDs are known to have the potential to delay parturition through a tocolytic effect. The use of NSAIDs in the immediate post-partum period may interfere with uterine involution and expulsion of fetal membranes. Cows should be monitored carefully for placental retention and metritis if Banamine Transdermal pour-on is used within 24 hours after parturition.

Not for use in beef and dairy bulls intended for breeding over 1 year of age because reproductive safety has not been evaluated.

Safety

Not for use in humans. Keep out of reach of children. Flunixin transdermal solution is a potent non-steroidal anti-inflammatory drug (NSAID), and ingestion may cause gastrointestinal irritation and bleeding, kidney, and central nervous system effects.

This product has been shown to cause severe and potentially irreversible eye damage (conjunctivitis, iritis, and corneal opacity) and irritation to skin in laboratory animals. Users should wear suitable eye protection (face shields, safety glasses, or goggles) to prevent eye contact; and chemical resistant gloves and appropriate clothing (such as long-sleeve shirt and pants) to prevent skin contact and/or drug absorption. Wash hands after use.

In case of accidental eye contact, flush eyes immediately with water and seek medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses. In case of accidental skin contact and/or clothing contamination, wash skin thoroughly with soap and water and launder clothing with detergent. In case of ingestion do not induce vomiting and seek medical attention immediately. Probable mucosal damage may contraindicate the use of gastric lavage. Provide product label and/or package insert to medical personnel.

Contact

U.S. only: Merck Animal Health livestocktechsrvc@merck-animal-health.com or call 1-800-211-3573
For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov
For additional information, please see the product label.

References

1. Technical Bulletin SPAH-BA-58.

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