Florophenicol 30% Inj.

Solution for parenteral administration

Composition

Contains per ml:

• Florfenicol – 300 mg.
• Excipients ad – 1 ml.

Description:
Florfenicol is a synthetic broad-spectrum antibiotic effective against most Gram-positive and Gram-negative bacteria isolated from domestic animals. Florfenicol acts by inhibiting protein synthesis at the ribosomal level and is bacteriostatic. 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, and against the bacterial pathogens most commonly isolated in respiratory diseases in pigs, including Actinobacillus pleuropneumoniae and Pasteurella multocida.

Indications

Florfenicol 30% is indicated for 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. It is additionally indicated for treatment of acute outbreaks of respiratory disease in pigs caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.

Contra indications

• Not for use in cattle producing milk for human consumption.
• Not to be used in adult bulls or boars intended for breeding purposes.
• Do not administer in cases of previous allergic reactions to florfenicol.

Side effects
In cattle, a decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment. Administration of the product by the intramuscular and subcutaneous routes may cause inflammatory lesions at injection site which persist for 14 days.

In swine, commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/oedema which may affect 50% of the animals. These effects can be observed for one week. Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen up to 28 days.

Dosage
For subcutaneous or intramuscular injection.

Cattle:
Treatment (IM) : 1 ml per 15 kg body weight, twice at a 48-h interval.
Treatment (SC) : 2 ml per 15 kg body weight, administered once.
Prevention (SC) : 2 ml per 15 kg body weight, administered once.

The injection should only be given in the neck. The dose should not exceed 10 ml per injection site.

Swine : 1 ml per 20 kg body weight (IM), twice at a 48-hour interval.

The injection should only be given in the neck. The dose should not exceed 3 ml per injection site.

It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours after the second injection. If clinical signs of respiratory disease persist 48 hours after the last injection, treatment should be changed using another formulation or another antibiotic and continued until clinical signs have resolved. Note: Florfenicol 30% is not for use in cattle producing milk for human consumption.

Withdrawal times
– For meat:
Cattle : 30 days (IM route).
44 days (SC route).
Swine : 18 days.

Packaging

• Vial of 100 ml.