Product Ref: PFA1801 Category: A
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Category | POM-V |
Temperature | Ambient |
MA/VM/EU No: | 42058/4000 |
Species |
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VMD Link | https://www.vmd.defra.gov.uk/productinformationdatabase/files/SPC_Documents/SPC_154672.PDF |
NOAH Link | |
Dosage | 6 mg/kg bodyweight (1 ml/30 kg bodyweight) as a single injection by the subcutaneous or intravenous route. If clinical signs of respiratory or enteric disease persist 48 hours after the first injection, an additional dose at 6 mg/kg bodyweight may be administered. It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours. For the treatment of acute bovine mastitis, Advocin 180 should be administered at 6 mg/kg bodyweight (1 ml/30 kg bodyweight) as a single injection by the subcutaneous or intravenous route. The clinical signs should be monitored carefully and supportive therapy should be given as appropriate. If clinical signs of acute bovine mastitis persist 36-48 hours after the first injection, the antibiotic treatment should be reviewed. It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 36-48 hours. For treatment of cattle weighing more than 450 kg, divide the subcutaneous dose so that no more than 15 ml are injected at one site. When dosing a large number of animals from a single vial, the use of an automatic syringe is recommended to avoid excessive broaching of the rubber stopper. |
Withdrawals | Do not use in cases of hypersensitivity to the active substance, to other (fluoro)quinolones or to any of the excipients. Use of the product deviating from the instructions given above may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. For fluoroquinolones as a class, over-dosage at multiples of the recommended dose has been shown to induce erosion of articular cartilage. Care should be taken to dose accurately and Advocin 180 should be used with caution in animals with joint disease or cartilage growth disorders. Subcutaneous injection of the product induces a moderate inflammatory response in the tissue around the injection site. The resultant lesions may persist for up to 30 days. At doses of three times the therapeutic dose (18 mg/kg bw), erythema of the nasal and ocular mucosae was induced and food intake was reduced. Studies in laboratory animals have shown adverse effects on reproduction. At high doses in rats (100 to 200 mg/kg/day), increase in foetal delayed ossification and in dilation of the cerebral ventricles were observed. Dams given high doses produced fewer live pups per litter and pup weight and survival were adversely affected. The safety of the product has not been established during pregnancy in cows. The use is not recommended during pregnancy. The safety of the product has not been assessed in breeding bulls. Withdrawal period Meat and offal: 8 days. Milk: 4 days. Operator warnings Persons with known hypersensitivity to (fluoro)quinolones should avoid contact with the product. Care should be taken to avoid accidental self-injection as it can induce a slight irritation. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician. In case of contact with skin or eyes rinse with plenty of water. Wash hands after use. Do not eat, drink or smoke during application. |