Cadorex Solution for Injection 300mg/ml

Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs. Qualitative and quantitative composition Each ml contains: active substance: Florfenicol 300 mg Indications for use, specifying the target species Cattle: Diseases caused by florfenicol susceptible bacteria: Treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Sheep: Treatment of ovine respiratory tract infections due to Mannheimia haemolytica and Pasteurella multocida susceptible to florfenicol. Pigs: Treatment of acute outbreaks of swine respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol. Contraindications Do not use in adult bulls and rams intended for breeding purposes. Do not administer to boars intended for breeding. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Special warnings for each target species Do not exceed the recommended treatment dose or the recommended duration of treatment. Special precautions for use This medicinal product does not contain any antimicrobial preservative. Special precautions for use in animals: The safety of the product has not been established in sheep under 7 weeks of age. Do not use in piglets of less than 2 kg. The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. 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 and subcutaneous routes may cause inflammatory lesions at injection site which persist for 14 days. In very rare cases, anaphylactic shocks have been reported in bovines. Sheep: A decrease in food consumption may occur during the treatment period. The treated animals recover quickly and completely upon termination of the treatment. Administration of the product by the intramuscular route may cause inflammatory lesions at the injection site which may persist up to 28 days. Typically, these are mild and transient. CADOREX 300 mg/ml Florfenicol solution for injection for cattle, sheep and pigs 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 (40ºC) associated with either moderate depression or moderate dyspnoea a week or more after administration of the second dose. 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. Use during pregnancy, lactation or lay Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic potential for florfenicol. Cattle and Sheep: The effect of florfenicol on bovine and ovine reproductive performance and pregnancy has not been assessed. Use only accordingly to the benefit/risk assessment by the responsible veterinarian. Pigs: The safety of the product in sows during pregnancy and lactation has not been demonstrated. Do not use the product during pregnancy and lactation. Amounts to be administered and administration route Cattle: Intramuscular route: 20 mg of florfenicol/kg bodyweight (equivalent to 1 ml of the product/ 15 kg bodyweight) to be administered twice 48 hours apart using a 16 gauge needle. Subcutaneous route: 40 mg of florfenicol/kg bodyweight (equivalent to 2 ml of the product/ 15 kg bodyweight) to be administered once using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml. The injection should only be given in the neck. Sheep: 20 mg of florfenicol/kg bodyweight (equivalent to 1 ml of the product/15 kg bodyweight) by intramuscular injection daily for three consecutive days. The volume administered per injection site should not exceed 4 ml. Pigs: 15 mg of florfenicol/kg bodyweight (equivalent to 1 ml of the product/20 kg bodyweight) by intramuscular injection into the neck muscle twice at 48 hours intervals using a 16-gauge needle. The volume administered per injection site should not exceed 3 ml. For intramuscular, it is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours after the second injection. If clinical signs of respiratory disease persist 48 hours after the last injection, treatment should be changed using another formulation or another antibiotic and continued until clinical signs have resolved. Wipe the stopper before removing each dose. BREATHING NEVER WAS SO EASY Use a dry sterile needle and syringe. To ensure a correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. As the vial should not be broached more than 25 times, the user should select the most appropriate vial size according to the target species to be treated. When treating groups of animals in one run, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper. The draw-off needle should be removed after treatment. Withdrawal period(s) Cattle: Meat and offal: by IM route: 30 days; by SC route: 44 days. Milk: Not authorised for use in lactating animals producing milk for human consumption including pregnant animals intended to produce milk for human consumption. Sheep: Meat and offal: by IM route: 39 days. Milk: Not authorised for use in lactating animals producing milk for human consumption including pregnant animals intended to produce milk for human consumption. Pigs: Meat and offal: by IM route: 18 days Shelf-life Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 28 days Special precautions for storage Store below 30ºC. Do not freeze. Pack sizes: Cardboard box containing 1 vial of 100 ml. Cardboard box containing 1 vial of 250 ml. Not all pack sizes may be marketed.