Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
TILMICOSIN
Huvepharma NV
QJ01FA91
TILMICOSIN
40
Premix for Med.Feedstuffs
POM
Porcine, Rabbits
Tilmicosin
Antibacterial
Authorised
2009-02-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tilmovet 40 g/kg Premix for medicated feeding stuff for pigs and rabbits 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 40 g tilmicosin per kg Excipients: For the 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 (weaned piglets and fattening 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. Do not use in animals hypersensitive to tilmicosin and when there is resistance to tilmicosin or cross resistance to other macrolides like tylosin, erythromycin or lincomycin. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES With regard to the management of respiratory disease outbreaks, it should be noted that acutely ill animals are likely to be inappetant and therefore require parenteral treatment. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________ Læs hele dokumentet