Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Tilmicosin
Industrial Veterinaria, S.A.
QJ01FA91
Tilmicosin
300 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Sheep
tilmicosin
Antibacterial
Authorised
2010-12-17
Health Products Regulatory Authority 18 June 2019 CRN0094DC Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Hymatil 300 mg/ml solution for injection for cattle and sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Tilmicosin.............................................................. 300 mg EXCIPIENTS: Propylene glycol.................................................... 250 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, yellowish to brown-yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: Treatment of bovine respiratory disease associated with _Mannheimia haemolytica_ and _Pasteurella multocida._ Treatment of interdigital necrobacillosis. Sheep: 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._ 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 _Staphyloccocus aureus_ and _Mycoplasma agalactiae_. Do not administer to lambs weighing less than 15 kg since there is a risk of overdose toxicity. Accurate weighing of lambs is important to avoid overdose. The use of a 2 ml or smaller syringe will facilitate accurate dosing. Health Products Regulatory Authority 18 June 2019 CRN0094DC Page 2 of Lugege kogu dokumenti