Kelacyl 100 mg/ml Solution for Injection 100ml

Target species Cattle and pigs (sows). 4.2 Indications for use, specifying the target species In cattle: - treatment of respiratory infections caused by strains of Histophilus somni, Mannheimia haemolytica, Mycoplasma bovis, Pasteurella multocida susceptible to marbofloxacin. - treatment of acute mastitis caused by strains of Escherichia coli susceptible to marbofloxacin during the lactation period. In pigs: - treatment of Postpartum Dysgalactia Syndrome –PDS-(Metritis Mastitis Agalactia syndrome), caused by bacterial strains susceptible to marbofloxacin. 4.3 Contraindications Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). Do not use in cases of hypersensitivity to the active substance,to any other quinolone or to any of the excipients. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced by gram-positive bacteria. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to (fluoro)quinolones should avoid contact with the veterinary medicinal 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 the label to the physician. In case of contact with skin or eyes, rinse with plenty of water. Wash hands after use. 4.6 Adverse reactions (frequency and seriousness) Transitory inflammatory lesions can occur very rarely at the injection site, without clinical impact, when administered via the intramuscular or subcutaneous route. Administration by the intramuscular route may cause very rarely transient local reactions such as pain and swelling at the injection site and inflammatory lesions which may persist for at least 12 days after injection. However, in cattle, the subcutaneous route was shown to be better tolerated locally than the intramuscular route. Therefore, the subcutaneous route is recommended in heavy cattle. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation or lay Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Safety of the veterinary medicinal product at 2 mg/kg body weight has been established in pregnant cows or in sucking calves and piglets when used in cows and sows. Can be used during pregnancy and lactation. Safety of the veterinary medicinal product at 8 mg/kg body weight has not been established in pregnant cows or in sucking calves when used in cows. Therefore, this dose regimen should be used only according to the benefit/risk assessment by the responsible veterinarian. In case of use in lactating cow, see section 4.11. 4.8 Interaction with other medicinal products and other forms of interaction None known.
Vat Rate: 20%