COMPOSITION
Florfenicol ................................................................................................................................................... 30g
Excipient qsp ........................................................................................................................................... 100 ml
PHARMACEUTICAL PROPERTIES
Florfenicol is a synthetic broad-spectrum antibiotic active against most Gram-positive and Gram-negative bacteria isolated from domestic animals. Florfenicol is a bacteriostatic antibiotic, which acts by inhibiting bacterial protein synthesis at the ribosome level. In vitro tests have shown that florfenicol is active against the pathogenic bacteria most commonly implicated in respiratory diseases including: Mannheimia haemolytica and Pasteurella multocida in cattle and sheep, and Histophilus somni in cattle.
Intramuscular administration of florfenicol at the recommended dose of 20 mg florfenicol per kg in cattle maintains effective blood levels for 48 hours. The mean maximum serum concentration (C max ) of 3.37 pg/ml appears 3.3 hours (t max ) after administration. The mean serum concentration, 24 hours after administration, is 0.77 pg/ml.
Intramuscular administration of florfenicol at the recommended dose of 40 mg florfenicol per kg in cattle maintains effective plasma concentrations for 63 hours. The maximum serum concentration (C max ) of approximately 5 pg/ml appears approximately 5.3 hours (t max ) after administration. The mean serum concentration 24 hours after administration is approximately 2 pg/ml. The mean elimination half-life is 18.3 hours.
After intramuscular administration of florfenicol (20 mg/kg) in sheep, the mean maximum serum concentration of 10 pg/ml is reached within 1 hour. After a third intramuscular administration, the maximum serum concentration of 11.3 pg/mL is reached in 1.5 hours. The elimination half-life is estimated at 13.76 ± 6.42 h. The bioavailability is about 90%.
TARGET SPECIES
Cattle and sheep.
INDICATIONS
Diseases caused by germs sensitive to florfenicol.
In cattle :
Treatment of respiratory tract infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni . The presence of the disease in the flock should be established before treatment.
In sheep :
Treatment of respiratory tract infections due to Mannheimia haemolytica and Pasteurella multocida .
ADMINISTRATION AND DOSAGE
In cattle :
- Deep intramuscular route: 20 mg of florfenicol per kg of bodyweight, i.e. 1 ml of solution per 15 kg of bodyweight, twice at 48 hour intervals.
- Subcutaneous route : 40 mg of florfenicol per kg of bodyweight, i.e. 2 ml of solution per 15 kg of bodyweight, once only.
- The volume administered should not exceed 10 ml per injection site. The injection must be carried out at the level of the animal's neck.
In sheep :
- Deep intramuscular route : 20 mg of florfenicol per kg of bodyweight, i.e. 1 ml of solution per 15 kg of bodyweight, per day for 3 consecutive days.
- The volume administered should not exceed 4 ml.
CONTRAINDICATIONS AND INTERACTIONS
- Do not administer to adult bulls and rams intended for breeding.
- Do not use in case of known hypersensitivity to the active substance.
- Do not use in animals producing milk intended for human consumption .
- Studies in laboratory animals have not revealed any teratogenic or foetotoxic effects. However, the effects of florfenicol in cows and ewes on reproductive performance and pregnancy have not been evaluated. The use of the specialty should only be done after evaluation of the benefit/risk ratio by the veterinarian.
SIDE EFFECTS
In cattle:
- Decreased food intake and softening of faeces may occur during treatment. Treated animals regain their appetite quickly and completely as soon as the treatment is stopped.
- Administration of the specialty by intramuscular and subcutaneous routes may cause inflammatory lesions at the injection site which may persist for 14 days.
- In very rare cases, anaphylactic shock has been reported in cattle.
In sheep:
- A decrease in food consumption may occur during treatment. Treated animals regain their appetite quickly and completely as soon as the treatment is stopped.
- Administration of the specialty by the intramuscular route may cause inflammatory lesions at the injection site which may persist for up to 28 days. Typically, these lesions are mild and transient .
PRECAUTIONS FOR USE
Precautions for use in animals :
- The use of the specialty should only be carried out after verification of the sensitivity of the strains and must take into account the recommendations of the antibiotic therapy.
- Respect the recommended dosage.
Precautions to be taken by the person administering the veterinary medicinal product to animals:
- In case of accidental contact with skin or eyes, rinse immediately with plenty of water.
- In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
WITHDRAWAL PERIOD
Meat and offal :
- Cattle :
- 30 days (intramuscular route)
- 44 days (subcutaneous route)
- Sheep : 39 days
Milk : Do not use in animals producing milk for human consumption.
STORAGE CONDITIONS
- Unopened container: Keep the product in the commercial packaging, protected from light and at a temperature not exceeding 25°C.
- After opening the bottle: 4 weeks.
PHARMACEUTICAL FORM AND PRESENTATION
Solution for injection.
Bottles of 20, 50, 100 and 250 ml.