Committee for Veterinary Medicinal Products
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چکیده
1. Lincomycin is an antibiotic derived from Streptomyces lincolnensis. It belongs to the lincosamide group which also includes pirlimycin and clindamycin. In veterinary medicine, it is used in monopreparations and in combination product with other antibiotics such as spectinomycin, sulfadimidine and gentamicin. It is administered to poultry orally, sometimes in the feed or drinking water, at doses equivalent to up to 50 mg/kg bw/day for up to 7 days. It is administered to swine orally, at doses of up to 10 mg/kg bw/day for up to 21 days, or intramuscularly at a dose of 15 mg/kg bw/day for up to 7 days. In calves and sheep, it is administered intramuscularly at doses of up to 15 mg/kg bw/day for up to 4 days. There is also a preparation containing lincomycin, neomycin and methylprednisolone for intramammary administration to dairy cattle; 1 tube (200 mg lincomycin) is administered per teat. Most of the safety studies used either "premix" grade lincomycin or lincomycin complying with the specification in the US Pharmacopoeia. The grades differed in their lincomycin factor B content, up to 5% in the case of the USP grade and up to 10% in the "premix" grade. It was considered that the differences in specification would not result in significant differences in toxicity.
منابع مشابه
The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/CVMP/315/98 - FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE: DEVELOPMENT PHARMACEUTICS FOR VETERINARY MEDICINAL PRODUCTS RELEASED FOR CONSULTATION BY CVMP
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An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 20 November 2014 EMA/CHMP/ CVMP/ SWP/169430/2012 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterina...
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