מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Tylosin tartrate
Dopharma Research B.V.
QJ01FA90
Tylosin tartrate
Powder for use in drinking water/milk
POM: Prescription Only Medicine as defined in relevant national legislation
tylosin
2022-12-23
1. NAME OF THE VETERINARY MEDICINAL PRODUCT_ _ TYLOGRAN, 1000 mg/g, granules for use in drinking water/milk for cattle (calves), pigs, chickens and turkeys (AT, BE, BG, CZ, CY, DE, DK, EE, EL, FI, HU, IE, IS, IT, LT, LU, LV, NL, NO, PL, PT, RO, SE, SK) TYLOGRAN, 100%, granules for use in drinking water/milk for cattle (calves), pigs, chickens and turkeys (FR) TYLOGRAN, 909 mg/g, granules for use in drinking water/milk for cattle (calves), pigs, chickens and turkeys (HR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1.1 g contains: ACTIVE SUBSTANCE: 1 g of tylosin (1000000 IU tylosin, equivalent to 1.1 g of tylosin tartrate) Almost white to slightly yellow, granular powder. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle (calves), pigs, chickens and turkeys. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Calves: treatment and metaphylaxis of - pneumonia caused by _Mycoplasma _ spp. Pigs: treatment and metaphylaxis of - enzootic pneumonia caused by _Mycoplasma hyopneumoniae_ and _Mycoplasma hyorhinis_ ; - Porcine Intestinal Adenomatose (PIA or Ileitis) associated with _Lawsonia intracellularis_ . Turkeys: treatment and metaphylaxis of - infectious sinusitis caused by _Mycoplasma gallisepticum_ . Chickens: treatment and metaphylaxis of - chronic respiratory diseases (CRD) caused by _Mycoplasma gallisepticum_ and _Mycoplasma synoviae_ ; - necrotic enteritis caused by _Clostridium perfringens_ . The presence of the disease in the group/flock must be established before the veterinary medicinal product is used. 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to tylosin or other macrolides. Do not use in animals with hepatic disorders. Do not use in horses. 3.4 SPECIAL WARNINGS Severely sick animals that exhibit an altered eating and drinking behaviour should be medicated parenterally. Do not use in cases of known resistance to tylosin or cross-resistance to other macrolides (MLS- resistance). 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: Due to likely variabi קרא את המסמך השלם