Merck Resflor Gold (Florfenicol and Flunixin Meglumine) Anti-Inflammatory Drug, 100mL

Resflor Gold (florfenicol and flunixin meglumine) is a simple bovine respiratory disease (BRD) treatment strategy. It involves a combination of two therapies in one dose: the powerful antibiotic florfenicol to kill or inhibit the disease-causing bacteria Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and, the fast-acting non-steroidal anti-inflammatory drug (NSAID) flunixin meglumine to reduce BRD-associated fever.

Key Benefits

• For treatment of bovine respiratory disease BRD associated with Mannheimia haemolytica, Pasteurella multocida,Histophilus somni, and Mycoplasma bovis,
• Control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

Indications

Resflor Gold is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.

A single subcutaneous dosage of 6 mL/hundred pounds can produce improvement in just six hours.1 Resflor Gold should be administered once by subcutaneous injection at a dose rate of 40mg florfenicol/kg body weight and 2.2mg flunixin/kg body weight (6 mL/100 lb). Do not administer more than 10 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated. For the 500 mL vial, do not puncture the stopper more than 20 times.

*Do not administer more than 10 mL at each site.

Caution

For subcutaneous use in beef and non-lactating dairy cattle only. Not for use in female dairy cattle 20 months of age or older or in calves to be processed for veal. The effects of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Resflor Gold, when administered as directed, may induce a transient reaction at the site of injection and underlying tissues that may result in trim loss of edible tissue at slaughter.

Contraindications

Do not use in animals that have shown hypersensitivity to florfenicol or flunixin.

Warnings:

NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains material that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothing. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.

For customer service or to obtain a copy of the MSDS, call 1-800-211-3573. For technical assistance or to report suspected adverse reactions, call 1-800-219-9286.

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 diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully monitored. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that have not been previously diagnosed. Since many NSAIDs possess the potential to produce gastrointestinal ulceration, concomitant use of Resflor Gold® with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored.

Flunixin is a cyclo-oxygenase inhibitory NSAID, and as with others in this class, adverse effects may occur with its use. The most frequently reported adverse effects have been gastrointestinal signs. Events involving suspected renal, hematologic, neurologic, dermatologic, and hepatic effects have also been reported for other drugs in this class.

Not for use in animals intended for breeding purposes. The effects of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. NSAIDs are known to have potential effects on both parturition 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. The effects of flunixin on imminent parturition have not been evaluated in a controlled study. NSAIDs are known to have the potential to delay parturition through a tocolytic effect.

Resflor Gold®, when administered as directed, may induce a transient reaction at the site of injection and underlying tissues that may result in trim loss of edible tissue at slaughter.

Residue Warnings:

Animals intended for human consumption must not be slaughtered within 38 days of treatment. This product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

Adverse Reactions:

Transient inappetence, diarrhea, decreased water consumption, and injection site swelling have been associated with the use of florfenicol in cattle. In addition, anaphylaxis and collapse have been reported post-approval with the use of another formulation of florfenicol in cattle. In cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use of flunixin meglumine.

Animal Safety

A target animal safety study was conducted to evaluate the effects of Resflor Gold® when administered to cattle subcutaneously at 1X, 3X, or 5X the labeled dose for three consecutive days (3X the labeled duration). Decreased feed and water consumption, and decreased body weights (secondary to decreased feed consumption) were observed in the 1X, 3X, and 5X groups. Injection site swellings were noted in the 1X, 3X, and 5X groups.

A separate injection site study was conducted in cattle. The study demonstrated that Resflor Gold®, when administered according to the label directions, may induce a transient local reaction in the subcutaneous and underlying muscle tissue.

Storage:

Do not store above 30°C (86°F). Use within 28 days of first use.