Summary of Product Characteristics.
Presentation:
Nuflor is a light golden sterile non-aqueous solution for injection, containing 300 mg/ml florfenicol.
Uses:
Florfenicol is a broad-spectrum synthetic antibiotic active against most Gram-positive and Gram-negative bacteria isolated from
domestic animals.
In pigs it is used for the treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
The product should be used in conjunction with susceptibility testing.
Dosage and Administration:
Wipe the stopper before removing each dose. Use a dry, sterile syringe and needle.
Do not use in piglets of less than 2 kg.
Do not broach the vial more than 25 times.
15 mg/kg bodyweight (1 ml per 20 kg) by intramuscular injection into the neck muscle twice at 48 hour intervals using a 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.
Contra-indications, warnings etc:
Meat and offal: 18 days.
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.
Do not administer to boars intended for breeding.
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.
Studies in laboratory animals have not revealed any evidence of embryo- or foeto-toxic potential. However, the safety of the product in sows during pregnancy and lactation has not been demonstrated. Use of NUFLOR Swine Injectable during pregnancy and lactation is not therefore recommended.
Operator warnings:
Do not use the product in known cases of sensitivity to propylene glycol and polyethylene glycols.
For animal treatment only.
Keep out of the reach of children.
Pharmaceutical precautions:
Do not store above 25°C. Do not refrigerate. Protect from frost.
Following withdrawal of the first dose, use the product within 28 days.
When the container is opened for the first time, the date on which any product remaining in the container should be discarded should be calculated. A statement of the in-use shelf life of the product is given on the package insert. This date should be written in the space provided on the label.
Discard unused material. Any unused product or waste material should be disposed of in accordance with guidance from your local waste regulatory authority.
Package quantities:
100 and 250ml glass vials
MA Number:
Vm 00201/4188 (UK), VPA 10277/74/1-5 (Ireland)
References:
- De Haas V and Lockwood PW. Report No A-28370.
Data on file, Schering Plough Animal Health.
- Terreni et al. IPVS 2002, Ames, Iowa, US.
Data on file, Schering-Plough Animal Health.
- Jackson JA and Lockwood PW. Report No. A-27625.
Data on file, Schering-Plough Animal Health.
- Sensitivity data on file, Schering-Plough Animal Health.
- Veterinary Laboratory Data from Rennes.
Data on file, Schering-Plough Animal Health.
Nuflor is only available from your veterinary surgeon from whom advice should be sought.
Further information is available from: Schering-Plough Animal Health, Division of Schering-Plough Ltd, Breakspear Road South, Harefield, Uxbridge, Middlesex UB9 6LS.
Date of preparation: April 2003 SP000667
Disclaimer: Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the product label or package insert.
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