Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Tilmicosin
Emdoka bvba
QJ01FA91
Tilmicosin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Sheep
Antimicrobial
Authorized
2011-04-20
Revised: June 2016 AN: 00650/2015 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 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 EXCIPIENT: 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 (pH=6). 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. Revised: June 2016 AN: 00650/2015 Page 2 of 8 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. 4.4SPECIAL 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 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. 4.5 SPECIAL PRECAUTIONS FOR USE _SPECIAL PRECAUTIONS FOR USE IN ANIMALS_ Official, national and regional antimicrobial policies Read the complete document