Resflor Gold: Product Information

RESFLOR GOLD- florfenicol and flunixin meglumine injection
Merck Sharp & Dohme Corp.

(Florfenicol and Flunixin Meglumine)
Antimicrobial/Non-Steroidal Anti-Inflammatory Drug

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.

PRODUCT INFORMATION

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

RESFLOR GOLD® is an injectable solution of the synthetic antibiotic florfenicol and the non-steroidal anti-inflammatory drug (NSAID) flunixin. Each milliliter of sterile RESFLOR GOLD® contains 300 mg florfenicol, 16.5 mg flunixin as flunixin meglumine, 300 mg 2-pyrrolidone, 35 mg malic acid, and triacetin qs.

INDICATION

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

DOSAGE AND ADMINISTRATION

RESFLOR GOLD® should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg 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.
RESFLOR GOLD® Dosage Guide *
ANIMAL WEIGHT(lb) DOSAGE(mL)
1006.0RecommendedInjectionLocationInjection Location Image
20012.0
30018.0
40024.0
50030.0
60036.0
70042.0
80048.0
90054.0
100060.0

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, concominant 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.

CLINICAL PHARMACOLOGY

The pharmacokinetics (PK) of florfenicol (Table 1) and flunixin (Table 2) after subcutaneous injection of RESFLOR GOLD® is described below:

Table 1. Mean (n=28) pharmacokinetic parameters for florfenicol in cattle after a single subcutaneous administration of RESFLOR GOLD (florfenicol dose of 40 mg/kg BW).
Mean Florfenicol PK parameters in Cattle
PKParameter AUC 0-t *(ng*hr/mL) AUC0-inf (ng*hr/mL) Cmax (ng/mL) Tmax § (hr) T½ (hr) MRT0-inf #(hr)
Mean 242527 247577 11151 6.25 28.5 27.3
SD ß 42741 41391 4194 3.87 9.91 11.6
Table 2. Mean (n=28) pharmacokinetic parameters for flunixin in cattle after a single subcutaneous administration of RESFLOR GOLD (flunixin dose of 2.2 mg/kg BW).
Mean Flunixin PK parameters in Cattle
PKParameter AUC 0-t *(ng*hr/mL) AUC0-inf (ng*hr/mL) Cmax (ng/mL) Tmax § (hr) T½ (hr) MRT0-inf #(hr)
*
AUC 0-t = Area under the plasma-concentration-time curve (AUC) from time zero to the last quantifiable concentrations
AUC0-inf = AUC from time zero to infinity
Cmax = Maximum plasma concentration
§
Tmax = Time at which Cmax was observed
T½ = Terminal elimination half-life
#
MRT0-inf = Mean residence time from time zero to infinity
Þ
n=27
ß
SD = Standard deviation
Mean 13370 14448Þ 1913 1.14 9.5Þ 11.4
SD ß 4964 5116 791 0.97 3.27 4.41
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