Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Tiamulin Hydrogen Fumarate
HCS bvba
QJ01XQ01
Tiamulin Hydrogen Fumarate
Granules for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Chickens, Pigs, Turkeys
Antimicrobial
Authorized
2018-01-16
Revised: February 2018 AN: 01672/2014 (amended pages) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tyawalt 450 mg/g granules for use in drinking water for pigs, chickens and turkeys (DE, BE, DK, ES, NL, PL, PT, UK) Tyawalt 364.28 mg/g granules for use in drinking water for pigs, chickens and turkeys (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCE: Tiamulin hydrogen fumarate 450 mg (corresponds to 364.28 mg of tiamulin base) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for use in drinking water White to almost white small granules. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs, chickens and turkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs Treatment of Swine Dysentery caused by _Brachyspira hyodysenteriae_ susceptible to tiamulin. The presence of the disease in the herd must be established before the product is used. Treatment of Porcine Colonic Spirochaetosis (colitis) caused by _Brachyspira pilosicoli_ susceptible to tiamulin_. _The presence of the disease in the herd must be established before the product is used. Treatment of Porcine Proliferative Enteropathy (ileitis) caused by _Lawsonia intracellularis _susceptible to tiamulin_. _The presence of the disease in the herd must be established before the product is used. Treatment and metaphylaxis of Enzootic Pneumonia caused by _Mycoplasma hyopneumoniae_, including infections complicated by _Pasteurella multocida _susceptible to tiamulin_. _The presence of the disease in the herd must be established before the product is used. Page 1 of 9 Revised: February 2018 AN: 01672/2014 (amended pages) Treatment of Pleuropneumonia caused by _Actinobacillus _ _pleuropneumoniae_ susceptible to tiamulin. The presence of the disease in the herd must be established before the product is used. Chickens Treatment and metaphylaxis of Chronic Respiratory Disease caused by _Mycoplasma gallisepticum_ and Airsacculitis and Infectious Syn Read the complete document