FLORFENIKEL 300MG/ML INJ 100ML

Target Species Cattle, pigs. 4.2 Indications for use, specifying the target species Cattle: Treatment of respiratory tract infections due to strains of Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol. Pigs: Treatment of acute outbreaks of swine respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol. 4.3 Contraindications Do not use in adult bulls and boars intended for breeding purposes. Do not use in piglets of less than 2 kg. Do not use in case of hypersensitivity to florfenicol or to any of the excipients. Do not use in case of resistance to the active substance. Do not administer intravenously. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals The stopper must be cleaned before removing each dose. Use a dry, sterile syringe and needle. Use of 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 florfenicol and may decrease the effectiveness of treatment with other amfenicols and other antimicrobials 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. Avoid direct contact with skin, mouth and eyes. If eye exposure occurs, flush eyes immediately with clean water. If skin exposure occurs, wash the affected area with clean water. If accidental ingestion occurs, rinse the mouth with plenty of water and seek medical advice immediately. Wash hands after use. People with known hypersensitivity to florfenicol should avoid contact with the veterinary medicinal product. Do not smoke, eat or drink while handling this product. 4.6 Adverse reactions (frequency and seriousness) Cattle: 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 inflammatory lesions at injection site which persist for 14 days. In very rare occasions, anaphylactic reactions were observed. 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). 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. Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen up to 28 days. Under field conditions, approximately 30% of treated pigs may present pyrexia (40oC) associated with either moderate depression or moderate dyspnoea a week or more after administration of the second dose. 4.7 Use during pregnancy and lactation Studies in laboratory species have not produced any evidence of teratogenic or foetotoxic effects. Safety during pregnancy and lactation has not been investigated in the target species. Use only accordingly to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction No data available.
Vat Rate: 20%