Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Tilmicosin
Dopharma Research B.V.
QJ01FA91
Tilmicosin
250 milligram(s)/millilitre
Solution for use in drinking water/milk
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Chickens, Pigs, Turkeys
tilmicosin
Antibacterial
Authorised
2018-05-04
Health Products Regulatory Authority 03 October 2019 CRN008WJY Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pulmovet 250 mg/ml solution for use in drinking water or milk replacer for cattle, pigs, chickens and turkeys 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: _ACTIVE SUBSTANCE:_ Tilmicosin (as tilmicosin phosphate): 250 mg _EXCIPIENTS:_ Propyl gallate (E310): 0.2 mg Disodium edetate: 2.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for use in drinking water or milk replacer. Clear yellow to brown solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (pre-ruminant), pigs, chickens (except hens producing eggs for human consumption) and turkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Calves: For the treatment and metaphylaxis of bovine respiratory disease, associated with _Mannheimia haemolytica_, _Pasteurella _ _multocida_, _Mycoplasma bovis_ and _M. dispar_ susceptible to tilmicosin. Pigs: For the treatment and metaphylaxis of respiratory disease associated with _Mycoplasma hyopneumoniae_, _Pasteurella _ _multocida_, _Actinobacillus pleuropneumoniae_ susceptible to tilmicosin. Chickens: For the treatment and metaphylaxis of respiratory disease associated with _Mycoplasma gallisepticum_ and _M. synoviae_ susceptible to tilmicosin. Turkeys: For the treatment and metaphylaxis of respiratory disease associated with _Mycoplasma gallisepticum_ and _M. synoviae_ susceptible to tilmicosin. The presence of the disease in the group/flock must be established before the product is used. 4.3 CONTRAINDICATIONS Do not allow horses and other equines access to drinking water containing tilmicosin. Do not use in case of hypersensitivity to tilmicosin or to any of the excipients. Health Products Regulatory Authority 03 October 2019 CRN008WJY Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Important: Must be diluted before administration to animals. Pigs, chickens and turkeys: Water consu Læs hele dokumentet