国: アイルランド
言語: 英語
ソース: HMA (Heads of Medicines Agencies)
tylosin tartrate 20 mg/g
Huvepharma N.V.
QJ01FA90
Granules
tylosin
Pigs
2011-04-28
Page 1 of 10 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PHARMASIN 20 MG/G ORAL GRANULES FOR PIGS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tylosin (as tylosin phosphate) : 20 mg per g (equivalent to 20 000 IU) For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Granules Light tan coloured, free flowing granules. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) Pigs: Treatment and prevention of clinical signs of porcine proliferative enteritis (porcine intestinal adenomatosis, proliferative hemorrhagic enteropathy, ileitis) associated with _Lawsonia intracellularis _when the disease has been diagnosed at the group level._ _ 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance and/or to any of the excipients of the product. Do not use in animals with known hypersensitivity to tylosin and other macrolides. Do not use where cross-resistance to other macrolides (MLS resistance) is suspected. Do not use in animals vaccinated with tylosin-sensitive vaccines either at the same time or within 1 week previously. Do not use in animals with hepatic disorders. Do not use in horses – danger of inflammation of the cecum. Page 2 of 10 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) None. 4.5 SPECIAL PRECAUTIONS FOR USE 4.5.1 Special precautions for use in animals This product is only for administration in small quantities of feed for immediate consumption, to individual animals. Animals with acute infections may have a reduced feed intake and should 完全なドキュメントを読む