Country: Bretland
Tungumál: enska
Heimild: VMD (Veterinary Medicines Directorate)
Tilmicosin
Elanco Europe Ltd
QJ01FA91
Tilmicosin
Premix for medicated feeding stuff
POM-V - Prescription Only Medicine – Veterinarian
Pigs, Rabbits
Antimicrobial
Authorized
1995-11-17
Amended Pages: August 2022 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pulmotil G200 Premix for Medicated Feeding Stuff 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Tilmicosin (as phosphate) 200 g/kg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff. A yellowish tan to reddish tan free-flowing granular material. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and rabbits. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: Prevention and treatment of respiratory disease caused by _Actinobacillus _ _pleuropneumoniae, _ _Mycoplasma _ _hyopneumoniae, _ _Pasteurella multocida_ and other organisms sensitive to tilmicosin. Rabbits: Prevention and treatment of respiratory disease caused by _Pasteurella multocida_ and _Bordetella bronchiseptica_, susceptible to tilmicosin. 4.3 CONTRAINDICATIONS Horses or other Equidae, must not be allowed access to feeds containing tilmicosin. Horses fed with tilmicosin medicated feeds may present signs of toxicity with lethargy, anorexia, reduction of feed consumption, loose stools, colic, distension of the abdomen and death. Do not use in case of hypersensitivity to tilmicosin or to any of the excipients 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Under practical conditions, the management of respiratory disease outbreaks recognises that acutely ill animals are inappetant and require parenteral therapy. Amended Pages: August 2022 Page 2 of 7 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin related substances. Official, national and regional antimicrobial policies should be taken into account when the product is used. Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility te Lestu allt skjalið