Company name: Vétoquinol UK Ltd
Address: Vétoquinol House
Great Slade
Buckingham Industrial Park
Buckingham
MK18 1PA
Telephone: 01280 814500
Fax: 01280 825460
Email: office@vetoquinol.co.uk
Website: www.vetoquinol.co.uk
Kefloril 300mg/ml Solution for injection for cattle and pigs
Company name: Vétoquinol UK Ltd
Address: Vétoquinol House
Great Slade
Buckingham Industrial Park
Buckingham
MK18 1PA
Telephone: 01280 814500
Fax: 01280 825460
Email: office@vetoquinol.co.uk
Website: www.vetoquinol.co.uk
Solution for injection containing florfenicol 300mg. Light yellow to yellow, clear viscous liquid.
Swine: treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Cattle: diseases caused by florfenicol susceptible bacteria.
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.
Swine
15 mg/kg bodyweight (1 ml per 20 kg) by intramuscular injection into the neck muscle twice at
48-hour intervals using a dry, sterile 16-gauge needle.
The volume administered per injection site should not exceed 3 ml.
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.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Cattle
For treatment:
IM route: 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart using a 16 gauge needle.
SC route: 40 mg/kg bodyweight (2 ml/15 kg) to be administered once only using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml.
The injection should only be given in the neck.
For prevention:
SC route: 40 mg/kg bodyweight (2 ml/15 kg) to be administered once only using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml.
The injection should only be given in the neck.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Contra-indications, warnings, etc
Do not administer to boars and adult bulls intended for breeding purposes.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special precautions for use in animals
Swab the stopper before removing each dose. Use a dry, sterile syringe and needle.
Do not use in piglets of less than 2 kg.
The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.
Use a suitable draw-off needle or automatic dosing syringe to avoid excessive puncturing of the closure.
User warnings
Care should be taken to avoid accidental self-injection.
In case of accidental self injection, seek medical advice and show the label to the doctor.
Do not use the product in known cases of sensitivity to propylene glycol and polyethylene glycols.
Avoid direct contact with skin, eyes or mouth.
In case of accidental spillage of the solution onto skin, wash off immediately with soap and water.
In case of accidental contact with eyes, rinse immediately with plenty of water.
Adverse reactions (frequency and seriousness)
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.
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 route may cause swelling at the injection site which may persist for 14 days. Inflammation at the injection site may persist up to 32 days after administration.
Administration of the product by the subcutaneous route may cause swelling and inflammation at the injection site which may persist at least for 41 days.
Use during pregnancy, lactation or lay
Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic potential for florfenicol.
Swine: the safety of the product in sows during pregnancy and lactation has not been demonstrated. Use of the product during pregnancy and lactation is therefore not recommended.
Cattle: 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Cattle:
Not known.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Withdrawal Periods
Swine:
Meat and offal: 18 days
Cattle:
Meat and offal: by IM (at 20 mg/kg bodyweight, twice): 30 days
by SC (at 40 mg/kg bodyweight, once): 44 days
Milk: Not permitted for use in lactating animals producing milk for human consumption.
Incompatibilities
Shelf-life after first opening the immediate packaging: 28 days
This veterinary medicinal product does not require any special storage conditions.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Cardboard box containing 100 or 250 ml Type I amber glass bottle closed with a bromobutyl rubber stopper and aluminium seal.
Pharmacotherapeutic group: Antibacterials for systemic use ATCVet Code: QJ01BA90
Pharmacodynamic properties
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. However, bactericidal activity has been demonstrated in-vitro against Actinobacillus pleuropneumoniae, Pasteurella multocida, Mannheimia haemolytica and Histophilus somni.
In-vitro testing has shown that florfenicol is active against the bacterial pathogens most commonly isolated in respiratory diseases in pigs, including Actinobacillus pleuropneumoniae and Pasteurella multocida. Laboratory tests have also shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Acquired resistance to florfenicol is mediated by efflux pump resistance associated with a floR gene. Such resistance has not yet been identified in the target pathogens except for Pasteurella multocida. Cross resistance with chloramphenicol can occur.
Resistance to florfenicol and other antimicrobials has been identified in the food-borne pathogen Salmonella typhimurium.
Pharmacokinetic particulars
Swine:
After single intramuscular administration of the recommended dose of 15mg/kg to pigs maximum mean plasma concentration (Cmax) of 2.8 μg/ml occurs at 2 hours (Tmax) after dosing.
After administration to pigs by the intramuscular route, florfenicol is rapidly excreted, primarily in urine. Florfenicol is extensively metabolised.
Cattle:
Intramuscular administration at the recommended dose of 20 mg/kg maintains efficacious blood levels in cattle for 48 hours. Maximum mean plasma concentration (Cmax) of 3.86 μg/ml occurs at 5 hours (Tmax) after dosing. The mean plasma concentration 24 hours after dosing was 1.56 μg/ml.
After subcutaneous administration of the recommended dose of 40 mg florfenicol/kg b.w., maximum plasma concentration (Cmax) of approximately 3.5 μg/ml occurs approximately 7.0 hours (Tmax) after dosing. The mean plasma concentration 24 hours after dosing is approximately 2 μg/ml.
The harmonic mean elimination half life was 18.8 hours.
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