Χώρα: Γερμανία
Γλώσσα: Αγγλικά
Πηγή: HMA (Heads of Medicines Agencies)
tylosin phosphate 250 mg/g
Huvepharma N.V.
QJ01FA90
Granules
tylosin
Pigs
2009-03-12
SUMMARY OF PRODUCT CHARACTERISTICS PHARMASIN 250 MG/G ORAL GRANULES Huvepharma NV Page 1 of 13 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PHARMASIN 250 MG/G ORAL GRANULES FOR PIGS (BE, CZ, DE, IT, PL, NL) TYLMASIN GRANULAT (DK) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: Active substance: Tylosin (as tylosin phosphate) : 250 mg per g (equivalent to 250 000 IU) Excipients: For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Oral 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. SUMMARY OF PRODUCT CHARACTERISTICS PHARMASIN 250 MG/G ORAL GRANULES Huvepharma NV Page 2 of 13 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. SUMMARY OF PRODUCT CHARACTERISTICS PHARMASIN 250 MG/G ORAL GRANULES Huvepharma NV Page 3 of 13 4 Διαβάστε το πλήρες έγγραφο