Target species
Cattle and Pigs
Indications for use
Diseases caused by florfenicol susceptible bacteria:
Cattle:
Therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.
Swine:
Treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida.
Contra-indications
Do not administer to adult bulls or boars intended for breeding purposes.
Do not administer to cattle producing milk for human consumption.
Do not administer to animals with known hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None
Special precautions for use
Special precautions for use in animals
Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Do not use in piglets of less than 2 kg.
Swab the septum before removing each dose.
Use a dry, sterile syringe and needle.
Special precaution to be taken by the person administering the medicinal product to animals.
Care should be taken to avoid accidental self-injection.
Avoid contact with eyes and skin.
If eye exposure occurs, flush eyes immediately with clean water.
If skin exposure occurs, wash the affected area with clean water.
Wash hands after use.
People with known hypersensitivity to florfenicol should avoid contact with the veterinary medicinal product.
Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women, or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self injection.
Other Precautions
The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.
Adverse reactions
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 veterinary medicinal product may cause inflammatory lesions at injection site which persist for up to 14 days.
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 for up to 28 days.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in cattle and swine during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only accordingly to the benefit/risk assessment by the responsible veterinarian
Interactions
None known
Amounts to be administered and administration route
Cattle:
20 mg/kg body weight (1 ml of SELECTAN per 15 kg) by intramuscular route to be administered twice 48 hours apart.
The volume administered per injection site should not exceed 10 ml.
Swine:
15 mg/kg body weight (1 ml of SELECTAN per 20 kg) by intramuscular injection into the neck muscle twice at 48 hours intervals.
The volume administered per injection site should not exceed 3 ml.
Overdose
In swine, after administration of 3 times the recommended dose or more a reduction in feeding, hydration and weight gain has been observed. After administration of 5 times the recommended dose or more vomiting has also been noted.
Withdrawal periods
Cattle: Meat and offal: 30 days.
Not permitted for use in lactating animals producing milk for human consumption.
Swine: Meat and offal: 18 days.