Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Tilmicosin
Dopharma Research B.V.
QJ01FA91
Tilmicosin
Solution for use in drinking water/milk
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Chickens, Pigs, Turkeys
Antimicrobial
Authorized
2018-05-14
Revised: February 2024 AN: 03332/2022 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pulmovet 250 mg/ml solution for use in drinking water/milk for cattle, pigs, chickens and turkeys 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Tilmicosin (as tilmicosin phosphate): 250 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _ QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCt Propyl gallate (E310) 0.2 mg Disodium edetate 2.0 mg Phosphoric acid, concentrated (for pH adjustment) Purified water Clear yellow to brown solution. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle (pre-ruminant), pigs, chickens (except hens producing eggs for human consumption) and turkeys. 3.2 INDICATIONS FOR USE FOR EACH 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 _Pasteurella multocida_, _Actinobacillus pleuropneumoniae_ and _Mycoplasma hyopneumoniae_ susceptible to tilmicosin. Chickens: For the treatment and metaphylaxis of respiratory disease associated with _Mycoplasma gallisepticum_ and _M. synoviae_ susceptible to tilmicosin. Revised: February 2024 AN: 03332/2022 Page 2 of 8 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 veterinary medicinal product is used. 3.3 CONTRAINDICATIONS Do not allow horses and other equines access to drinking water containing tilmicosin. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS Important: Must be diluted before administration to animal Read the complete document