Norfenicol 300 mg/ml Solution for Injection for Cattle and Swine.
Cattle and Swine.
Indications for use, specifying the target species
Cattle: Treatment of respiratory tract infections in clinically diseased cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, susceptible to Florfenicol
Swine: Treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to Florfenicol.
Do not use in adult bulls or boars intended for breeding purposes.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cases of known resistance.
Special warnings None.
Special precautions for use
i. Special precautions for use in animals Do not use in piglets of less than 2 kg. Use a suitable draw-off needle or automatic dosing syringe to avoid excessive puncturing of the closure. Florfenicol should be used for treatment of severe infections only. Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the florfenicol and may decrease the effectiveness of treatment with other antimicrobials (e.g. Ceftiofur) due to the potential for crossresistance.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Do not use the product in known cases of sensitivity to the active substance or to any of the excipients. Care should be taken to avoid accidental self-injection.
Adverse reactions (frequency and seriousness)
Cattle: Administration of the product by the intramuscular or subcutaneous route may cause inflammatory lesions (swelling and hardness) at the injection site which may persist for 31 days. 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. In very rare cases, anaphylactic shock has been reported in cattle.
Pigs: 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. Under field conditions approximately 30 % of treated pigs presented with pyrexia (40?C) associated with either moderate depression or moderate dyspnea a week or more after administration of the second dose.