Florkem (Canada)

Company: Ceva Animal Health

Florfenicol Injection 300 mg/mL

Veterinary Use Only

Sterile antibiotic for cattle and swine

DIN 02458527

For Intramuscular and Subcutaneous use in Beef and Non-lactating Dairy Cattle only, and for Intramuscular use in Swine.

Description

Florkem^® is a light yellow to straw coloured, slightly viscous solution. Each millilitre contains 300 mg of the active ingredient florfenicol.

Florkem Indications

Cattle: Florkem^® Injectable Solution is indicated for the treatment of bovine respiratory disease complex, also called shipping fever, associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni (Haemophilus somnus). Florkem^® Injectable Solution is also indicated for the reduction of morbidity associated with bovine respiratory disease (BRD) in feedlot calves, caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni (Haemophilus somnus), during the first 28 days in the feedlot, when administered at the time of arrival. Florkem^® 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: Florkem^® Injectable Solution is indicated for the treatment of swine respiratory diseases associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

Dosage and Administration

Cattle: Florkem^® 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. For feedlot calves at high risk of developing BRD, only the subcutaneous route (SC) of administration (40 mg/kg, once on arrival in the feedlot) is recommended. Do not inject more than 10 mL into a single site.

On Arrival Treatment:

Note: To limit the development of antimicrobial resistance, Florkem^® should only be used as an arrival treatment when: 1) BRD has been diagnosed; and 2) calves are at “high risk” of developing BRD. One or more of the following factors typically characterizes calves at “high risk” of developing BRD. Calves are from multiple farm origins, and/or calves have extended transport times (that may have included few if any rest stops), and/or ambient temperature change(s) from origin to arrival of 17°C or more, and/or animals have had continued exposure to extremely wet and cold weather conditions, and/or calves have experienced excessive shrink or stressful processing procedures, such as castration and dehorning.

Swine: Florkem^® 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 re-evaluated.

CAUTIONS:

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.

Warnings

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 20 months of age or older. Not for use in veal calves. The withdrawal period has not been established in pre-ruminating calves. To limit the development of antimicrobial resistance, Florkem^® should only be used as an arrival treatment in feedlot calves when BRD has been diagnosed and calves are at high risk of developing BRD.

Swine: Treated pigs must not be slaughtered for use in food for at least 15 days after the latest treatment with this drug. 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.

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.

Adverse Reactions

Transient inappetence, decreased water consumption, or diarrhea have been reported very rarely following treatment. Anaphylactic/allergic type reactions have been reported very rarely and may require treatment.

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 Histophilus somni (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 (Vd_ss) was 0.77 L/kg indicating excellent penetration of florfenicol into body tissues and fluids. The median area under the concentration vs time curve (AUC_o∞) was 5403 µg/mL x minutes. Intramuscular administration of florfenicol using the same dose resulted in a maximum mean serum concentration (C_max) of 3.21 µg/mL which occurred 200 minutes (T_max) 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 AUC_o∞ was 4242 µg/mL x minutes and the median bioavailability was 79.8%.

STORAGE CONDITIONS: Store at or below 25°C with minor temperature excursions up to 40°C. Use within 28 days of first puncture.

How Supplied

Florkem^® Injectable Solution is packaged in 50 mL, 100 mL and 250 mL multiple dose translucent multi-layer plastic vials.

Ceva Animal Health Inc. 150 Research Lane, Suite 225, Guelph ON N1G 4T2

1-800-510-8864

^®Florkem is a registered trade mark of Ceva Santé Animale, France

A0319-02

C5535-3120301

CPN: 1221129.1