Do not use in adult bulls intended for breeding purposes.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in case of resistance to the active substance.
Special precautions for safe use in the target species
Swab septum before removing each dose. Use a dry, sterile syringe and needle.
The veterinary medicinal product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.
Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and may decrease the effectiveness of treatment with other amfenicols, due to the potential for cross resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Do not use the product in known cases of sensitivity to propylene glycol.
Overdose symptoms, emergency procedures, antidotes), if necessary
None.
Adverse reactions
Cattle:
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Anaphylactic reaction
Undetermined frequency (cannot be estimated from the available data)
Reduced food intake1
Loose stool1
Injection site swelling2
Injection site inflammation3
1Quick and complete recovery upon termination of treatment.
2After intramuscular administration: may persist for 14 days; after subcutaneous administration: may persist for 41 days.
3After intramuscular administration: may persist for 32 days; after subcutaneous administration: may persist for 41 days.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Interactions
None known.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Environmental Safety
Special precautions for the protection of the environment:
The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.
Withdrawal Periods
Meat & Offal:
by IM (at 20 mg/kg bodyweight, twice): 30 days
by SC (at 40 mg/kg bodyweight, once): 44 days
Not authorised for use in animals producing milk for human consumption.