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Florfenicol 300 mg/mL
Sterile Injectable Antibiotic Solution
For Intramuscular and Subcutaneous use in Beef and Non-lactating Dairy Cattle only, and for Intramuscular use in Swine only.
VETERINARY USE ONLY
DESCRIPTION: NUFLOR is a light yellow to straw coloured, slightly viscous solution. Each millilitre contains; Active ingredient: 300 mg florfenicol; Inactive ingredients: 250 mg N-methyl-2-pyrrolidone, polyethylene glycol 300 q.s. 1.0 mL and 150 mg propylene glycol as a preservative.
CLINICAL PHARMACOLOGY: Florfenicol is a synthetic, broad spectrum antibiotic. In vitro and in vivo activity has been demonstrated against the most commonly isolated bacterial pathogens involved in bovine shipping fever including Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus. Also effective in vivo against other bacteria like; Fusobacterium necrophorum, Bacteroides melaninogenicus, both bacteria associated with foot rot, and Moraxella bovis associated with pinkeye. In swine, in vitro and in vivo activity has been demonstrated against bacterial pathogens commonly associated with swine respiratory diseases, including Actinobacillus pleuropneumoniae and Pasteurella multocida.
Florfenicol has also shown significant in vitro activity against the following gram negative pathogens of animals; Escherichia coli, Salmonella spp. and Klebsiella spp. Gram positive activity was shown in vitro against Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Streptococcus bovis, Streptococcus zooepidemicus, Streptococcus suis, Staphylococcus aureus, Staphylococcus intermedius and Staphylococcus epidermidis. In vitro activity against Mycoplasma hyopneumonia and Mycoplasma hyorhinis has also been detected. However, the clinical significance of this activity in cattle or swine is not known.
The pharmacokinetic profile of florfenicol was evaluated in cattle using single intravenous and intramuscular administration at the recommended dose of 20 mg/kg. Intravenous administration of florfenicol resulted in a mean peak serum concentration of 44.56 µg/mL five minutes after dosing and a mean serum concentration of 0.91 µg/mL twelve hours after dosing. The harmonic mean elimination half-life was 154 minutes and the median volume of distribution at steady state (Vdss) was 0.77 L/kg indicating excellent penetration of florfenicol into body tissues and fluids. The median area under the concentration vs time curve (AUCo∞) was 5403 µg/mL x minutes. Intramuscular administration of florfenicol using the same dose resulted in a maximum mean serum concentration (Cmax) of 3.21 µg/mL which occurred 200 minutes (Tmax) after dosing. The mean concentration 24 hours after dosing was 0.77 µg/mL. Florfenicol was detectable in the serum of most animals through 60 hours after dosing with a mean concentration of 0.19 µg/mL. The median AUCo∞ was 4242 µg/mL x minutes and the median bioavailability was 79.8%.
INDICATIONS: CATTLE: NUFLOR Injectable Solution is indicated for the treatment of bovine respiratory disease complex, also called shipping fever, associated with Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus. NUFLOR Injectable Solution is also indicated for the treatment of bovine interdigital phlegmon (foot rot, interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus and for the treatment of infectious bovine keratoconjunctivitis (IBK, Pinkeye) caused by Moraxella bovis. SWINE: NUFLOR Injectable Solution is indicated for the treatment of swine respiratory diseases associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.
DOSAGE AND ADMINISTRATION: CATTLE: NUFLOR Injectable Solution should be administered to cattle either by a single subcutaneous injection at a dose rate of 40 mg/kg body weight (6 mL/45 kg); or by intramuscular injection at a dose of 20 mg/kg body weight (3 mL/45 kg), a total of two doses with a 48 hour interval should be given. Do not inject more than 10 mL into a single site. SWINE: Nuflor Injectable Solution should be administered by intramuscular injection at a dose rate of 15 mg/kg body weight (2.25 mL/45 kg). A second dose should be administered 48 hours later. Do not inject more than 5 mL into a single site. The injection should only be given in the neck.
Clinical improvement should be evident in most treated subjects within 24 hours of initiation of treatment. If a positive response is not noted within 72 hours of initiation of treatment, the diagnosis should be reevaluated.
CAUTION: Transient diarrhea or transient inappetence may occur with the use of this drug. Appetite and stool will usually return to normal within a few days of the end of the treatment period. In swine, peri-anal inflammation and/or rectal eversion may be observed in more than 50% of treated animals. These effects should resolve completely within one week.
Not for use in breeding cattle or breeding swine. The effects of florfenicol on bovine or porcine reproductive performance, pregnancy and lactation have not been assessed.
WARNING: CATTLE: Treated animals must not be slaughtered for use in food for at least 36 days after the latest intramuscular treatment or for at least 55 days after the latest subcutaneous treatment with this drug. Not for use in dairy cows of breeding age. Not for use in veal calves. SWINE: Treated pigs must not be slaughtered for use in food for at least 15 days after the latest treatment with this drug. Exceeding the dose level or number of recommended treatments may result in illegal residues in edible tissues.
NOT FOR HUMAN USE. KEEP OUT OF THE REACH OF CHILDREN. This product contains materials that can be irritating to skin and eyes. Avoid direct contact with skin, eyes and clothes. 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.
Note: to reduce the possibility of excess trim at the site of injection, do not slaughter swine for at least 21 days after the latest treatment with this drug.
STORAGE CONDITIONS: Product should be stored between 2º-25ºC (36º -77ºF).
HOW SUPPLIED: NUFLOR Injectable Solution is packaged in 50 mL, 100 mL, 250 mL and 500 mL multiple dose glass vials.
® SCHERING PLOUGH ANIMAL HEALTH, DIVISION OF SCHERING CANADA INC., POINTE CLAIRE, QUÉBEC, H9R 1B4
NAC No.: 12080654