Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Tilmicosin
Emdoka
QJ01FA91
Tilmicosin
300 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Sheep
tilmicosin
Antibacterial
Authorised
2011-04-21
1. NAME OF THE VETERINARY MEDICINAL PRODUCT TILMODIL 300 mg/ml Solution for Injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Tilmicosin 300 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ Propylene glycol 250 mg Phosphoric acid (for pH adjustment) Water for injections Clear, yellowish to brown-yellowish solution. _ _ 3. CLINICAL PARTICULARS 3.1 TARGET SPECIES Cattle and sheep. 3.2 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_ . 3.3 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 cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS 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 real 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. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: Official, national and regional a Citiți documentul complet