Nuflor Minidose

Cattle

Nuflor Minidose Data Sheet

Presentation 
A clear colourless to yellow solution for injection containing 450 mg/ml florfenicol. 

Uses 
Preventive and therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol. The presence of the disease in the herd should be confirmed before administering preventive treatment. 

Dosage and administration 
Subcutaneous route: 40 mg/kg body weight (4ml/45 kg) to be administered once only. 
Intramuscular route: 20 mg/kg body weight (2 ml/45 kg) to be administered twice 48 hours apart. 
The injection should only be given in the neck. The dose volume given at any one injection site should not exceed 10 ml. 

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid under-dosing. 
Swab septum before removing each dose. Use a dry, sterile needle and syringe. 
For 250 ml vials, do not broach the vial more than 25 times. 

Contra-indications, warnings, etc 
Do not use in adult bulls intended for breeding purposes. 
Do not use in case of known hypersensitivity to the active substance or to any of the excipients. 
Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic potential for florfenicol. 
However, the effect of florfenicol on bovine reproductive performance and pregnancy has not been assessed. Use only according to the benefit-risk assessment by the responsible veterinarian. 

Special precautions for use in animals 
The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. 
Do not use where resistance to florfenicol or other amphenicols is known to occur.Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to florfenicol and other amphenicols. 
The prolonged or repeated use of the veterinary medicinal product should be avoided by improving farming management practices, cleaning and disinfection measures and eliminating any stress condition. 

Adverse reactions 

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. 
Subcutaneous injection of the product at the maximum recommended volume of 10 ml per injection site may cause transient local algesia and clinically obvious swelling at the injection site. Local algesia may persist for some days. 
Injection site swellings decrease over time but may persist for up to 61 days. 
Intramuscular injection of the product at the maximum recommended volume of 10 ml per injection site may cause transient local algesia and clinically obvious swelling at the injection site. Local algesia may persist for some days. 
Injection site swellings decrease over time but may persist for up to 24 days. Inflammatory lesions at the injection site (seen at necropsy) may persist for 37 days after injection. 

Operator warnings

Care should be taken to avoid accidental self-injection. In case of self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Avoid direct contact with skin, mouth and eyes. Wash hands after treatment. 
For animal treatment only. Keep out of the reach and sight of children. 

Withdrawal periods

Meat and offal: 
by SC (at 40 mg/kg body weight, once): 64 days. 
by IM (at 20 mg/kg body weight, twice): 37 days. 
Not permitted for use in lactating animalsproducing milk for human consumption. 

Pharmaceutical precautions 
This veterinary medicinal product does not require any special temperature storage conditions. 
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 
Keep the vial in the outer carton in order to protect from light. 
Shelf-life after first opening the immediate packaging: 28 days. 
Medicines should not be disposed of via wastewater or household waste. 
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 

Legal category 
POM-V 

Packaging Quantities 
50, 100 and 250 ml colourless type II glass multiple dose vials, sealed with bromobutyl rubber stoppers secured with aluminium overseal. Not all pack sizes may be marketed. 

Further information 
Nil 

Marketing authorisation number 
Vm 01708/4541. 

Significant Changes 
GTIN (Global Trade Item No) 
Nuflor Minidose 1x100ml: 
08713184083968, 
Nuflor Minidose 1x250ml: 
08713184083975