Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
TIAMULIN FUMARATE
Huvepharma NV
QJ01XX
TIAMULIN FUMARATE
450 mg/g
Granules
POM
Fowl - Chicken, Fowl - Turkey, Porcine
Other antibacterials
Antibacterial
Authorised
2009-03-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmulin 450 mg/g granules for use in drinking water for pigs, chickens and turkeys 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each gram contains tiamulin hydrogen fumarate 450.0 mg (equivalent to tiamulin 364.2 mg) EXCIPIENTS: For a full list of excipients: see section 6.1 3 PHARMACEUTICAL FORM Granules for use in drinking water. White to pale yellow granules. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs, chickens and turkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs For the treatment of swine dysentery caused by tiamulin-susceptible _Brachyspira hyodysenteriae_. For the treatment of enzootic pneumonia caused by tiamulin-susceptible _Mycoplasma hyopneumoniae_. Chickens Treatment and metaphylaxis of chronic respiratory infections (CRD) and air sacculitis caused by tiamulin-susceptible strains of _Mycoplasma gallisepticum _and _Mycoplasma synoviae_. Turkeys Treatment and metaphylaxis of infectious sinusitis and air sacculitis caused by tiamulin-susceptible strains of _Mycoplasma gallisepticum _and _Mycoplasma synoviae _and _Mycoplasma meleagridis_. The presence of the disease in the herd or flock must be established before use. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient or to any of the excipients. Do not use in known cases of resistance to tiamulin. Do not administer products containing ionophores such as monensin, salinomycin or narasin during or for at least 7 days before or after treatment with the product. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 24/05/2016_ _CRN 7019992_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EAC Прочетете целия документ