Each ml contains Florfenicol 300 mg
1. Florfenicol is a synthetic broad spectrum antibiotic effective against most Gram-positive and Gram-negative bacteria isolated from domestic animals.
2. Florfenicol acts by inhibiting protein synthesis at the ribosomal level and is bacteriostatic.
3. Laboratory tests have shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Arcanobacterium pyogenes.
4. Florfenicol is considered to be a bacteriostatic agent, but in vitro studies of florfenicol demonstrate bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni
1. Intramuscular administration at the recommended dose of 20mg/kg maintains efficacious blood levels in cattle for 48 hours.
2. Maximum mean serum concentration (Cmax) of 3.37μg/ml occurs at 3.3 hours (Tmax) after dosing.
3. The mean serum concentration 24 hours after dosing was 0.77μg/ml.
4. The administration of the product by subcutaneous route at the recommended dosage of 40mg/kg maintains bovine efficacious blood levels in cattle (ie above the MIC90 of the main respiratory pathogens) for 63 hours.
5. Maximum serum concentration (Cmax) of approximately 5 μg/ml occurs approximately 5.3 hours (Tmax) after dosing.
6. The mean serum concentration 24 hours after dosing is approximately 2 μg/ml.
7. The harmonic mean elimination half life was 18.3 hours.
Indications for use
1. Diseases caused by florfenicol susceptible bacteria.
2. Preventive and therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of the disease in the herd should be established before preventive treatment.
1. Not to be used in adult bulls intended for breeding purposes.
2. Not for use in cattle producing milk for human consumption.
Use during pregnancy and lactation
3. Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic potential for florfenicol.
4. However, the effect of florfenicol on bovine reproductive performance and pregnancy has not been assessed. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other veterinary medicinal products
Dosage and method of administration
IM route: 20 mg/kg bodyweight (1ml/15kg) to be administered twice 48 hours apart.
1. SC route: 40 mg/kg bodyweight (2ml/15kg) to be administered once only
2. The dose volume given at any one injection site should not exceed 10ml.
3. The injection should only be given in the neck.
Overdose (symptoms, emergency procedures, antidotes)
Special warnings for each target species
Meat and offal*:
1. by IM (at 20 mg/kg bodyweight, twice): 30 days
2. by SC (at 40 mg/kg bodyweight, once): 44 days
1. Not permitted for use in lactating animals producing milk for human consumption.
2. The withdrawal period is calculated from the last administration of the drug. It should be noted that whatever the withdrawal period no food of animal origin can be given to humans during the period of treatment.
1. Shelf-life of the veterinary product as packaged for sale: 2 years
2. Following withdrawal of the first dose, use the product within 28 days.
Special precautions for storage
1. Do not store above 25°C
2. Do not refrigerate
3. Protect from frost.
100 ml bottle