Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Tilmicosin
Elanco Europe Ltd
QJ01FA91
Tilmicosin
Concentrate for oral solution
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Chickens, Pigs, Turkeys
Antimicrobial
Authorized
2000-04-04
Revised: September 2020 AN: 00822/2020 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pulmotil AC 250 mg/ml Concentrate for Oral Solution for Use in Drinking Water or Milk Replacer 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Tilmicosin (as phosphate) 250 mg/ml EXCIPIENTS: Propyl gallate 0.2 mg/ml Disodium edetate 2.0 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for Oral Solution for use in drinking water or milk replacer. Clear yellow to amber coloured solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (except hens producing eggs for human consumption), Turkeys Pigs Calves (non ruminant) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: For the treatment and metaphylaxis of respiratory disease in pig herds, associated with _Mycoplasma hyopneumoniae, Pasteurella multocida, _ _Actinobacillus pleuropneumoniae _and other organisms susceptible to tilmicosin. Chickens: For the treatment and metaphylaxis of respiratory disease in chicken flocks, associated with _Mycoplasma gallisepticum _and _M. synoviae. _ Turkeys: For the treatment and metaphylaxis of respiratory disease in turkey flocks, associated with _Mycoplasma gallisepticum _and _M. synoviae. _ Calves: For the treatment and metaphylaxis of bovine respiratory disease, associated with _Mannheimia haemolytica, Pasteurella multocida, Mycoplasma _ _bovis, M. dispar _and other organisms susceptible to tilmicosin. The presence of the disease in the group/flock must be established before the product is used. Revised: September 2020 AN: 00822/2020 Page 2 of 7 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Important: Must be diluted before administration to animals. Pigs, chickens and turkeys: Water consumption should be monitored in order to guarantee adequat Read the complete document