País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Tilmicosin phosphate
Elanco GmbH
QJ01FA91
Tilmicosin phosphate
200 gram(s)/kilogram(s)
Premix for medicated feeding stuff
POM: Prescription Only Medicine as defined in relevant national legislation
tilmicosin
Authorised
1997-01-24
Health Products Regulatory Authority 24 July 2018 CRN000YKH Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pulmotil G200 Premix for medicated feedingstuff 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 feedingstuff. 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 E_quidae_, must not be allowed access to feeds containing tilmicosin. Horses fed with tilmicosin medicated feeds may present signs of toxicity with Health Products Regulatory Authority 24 July 2018 CRN000YKH Page 2 of 7 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. 4.5 SPECIAL PRECAUTIONS FOR USE 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 tilmi Llegiu el document complet