Fenflor 300mg Injection for Cattle 250ml

Target species Cattle. 4.2 Indications for use, specifying the target species Diseases caused by florfenicol susceptible bacteria. Treatment and metaphylaxis of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, where the presence of the disease in the herd has been established. 4.3 Contraindications 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. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals Swab septum before removing each dose. Use a dry, sterile syringe and needle. The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. Use of the 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. 4.6 Adverse reactions (frequency and seriousness) 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. On very rare occasions, anaphylactic reactions have been reported. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 4.7 Use during pregnancy, lactation or lay 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 accordingly to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction None known.