Resflor Gold® Antimicrobial/Non Steroidal Anti-inflammatory

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.
  • The fast-acting non-steroidal anti-inflammatory drug (NSAID) flunixin meglumine to reduce BRD-associated fever.

Efficacy
In a multi-site field study, calves with naturally occurring BRD were treated with RESFLOR GOLD®, Nuflor Gold® (NADA 141-265), or saline. A treatment success was defined as a calf with normal respiration to mild respiratory distress, normal attitude to mildly depressed, and a rectal temperature < 104.0 °F on Day 11. The treatment success rate for BRD for the RESFLOR GOLD® treatment group (68.4%) was statistically significantly greater (p =0.0255) compared to the saline control treatment group (42.9%). RESFLOR GOLD® was non-inferior to Nuflor Gold® for the treatment of BRD, with a one-sided 95% lower confidence bound for the difference between the two treatments equal to -13.2%. In the same study, the change in rectal temperature from pre-treatment to six hours post-treatment was evaluated to determine the effectiveness of RESFLOR GOLD® for the control of BRD-associated pyrexia. The proportion of calves whose rectal temperatures decreased by ≥ 2.0 °F from pre-treatment to six hours post-treatment was statistically significantly greater (p = 0.0019) in the RESFLOR GOLD® treatment group compared to the saline control treatment group. The mean decrease in rectal temperature from pre-treatment to six hours post-treatment was statistically significantly greater in the RESFLOR GOLD® treatment group compared to the Nuflor Gold® and saline control treatment groups (p = 0.0031 and 0.0002, respectively). The effectiveness of RESFLOR GOLD for the treatment of BRD associated with Mycoplasma bovis was demonstrated by examining the M. bovis data from cattle enrolled in the BRD treatment study described above. There were numerically more treatment successes (6 of 8 calves, 75%) than treatment failures (2 of 8 calves, 25%) in RESFLOR GOLD-treated calves that cultured positive for M. bovis pre-treatment.

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.

http://msd-safetydatasheets.com/frame.asp - Search for #SP001649

Description
Resflor Gold® is an injectable solution of the synthetic antibiotic florfenicol and the nonsteroidal 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.

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.

Administration and Dosage
A single subcutaneous dosage of 6 mL/hundred pounds can produce improvement in just six hours! 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 500mL vial, do not puncture the stopper more than 10 times.

Resflor Gold® Dosage Guide®

ANIMAL WEIGHT (lb)DOSAGE (mL)
1006.0
20012.0
30018.0
40024.0
50030.0
60036.0
70042.0
80048.0
90054.0
100060.0

* 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 and flunixin on bovine reproductive performance, pregnancy, and lactation have not been determined. When administered according to the label directions, RESFLOR GOLD may induce a transient local reaction in the subcutaneous and underlying muscle tissue.

Supply Information
Resflor Gold is available in 100, 250, and 500mL sterile, multiple-dose, glass vials.

Contact information
US only:
Merck Animal Health
livestocktechsrvc@merck-animal-health.com
1-800-211-3574

Website
www.resflorgold.com

Product Label(s) and MSDS