Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
TILMICOSIN
Chanelle Pharmaceuticals Manufacturing Limited
QJ01FA91
TILMICOSIN
300 Mg/Ml
Solution for Injection
VPO-Vet.Practitioner Only
Bovine, Ovine
Tilmicosin
Antibacterial
Authorised
2009-11-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Milbotyl 300 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Tilmicosin 300 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle For the treatment of bovine respiratory disease associated with _Mannheimia haemolytica _and _Pasteurella multocida._ For the treatment of interdigital necrobacillosis. Sheep For the treatment of respiratory tract infections caused by _Mannheimia haemolytica _and _Pasteurella multocida._ Treatment of foot rot in sheep caused by _Dichelobacter nodosus _and _Fusobacterium necrophorum._ Treatment of acute ovine mastitis caused by _Staphylococcus aureus _and _Mycoplasma agalactiae_. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 08/06/2015_ _CRN 7018022_ _page number: 1_ 4.3 CONTRAINDICATIONS Do not administer intravenously. Do not administer intramuscularly. Do not administer to lambs weighing less than 15 kg. Do not administer to primates. Do not administer to pigs. Do not administer to horses and donkeys. Do not administer to goats. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES SHEEP The clinical trials did not demonstrate a bacteriological cure in sheep with acute mastitis caused by _Staphylococcus_ _aureus _and _Mycoplasma agalactiae._ Do not administer to lambs weighing less than 15 kg, since there is a real risk of overdosage toxicity. Accurate weighing of Belgenin tamamını okuyun