Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Tylosin
Huvepharma N.V.
QJ01FA90
Tylosin
Granules for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Chickens, Pigs, Turkeys
Antimicrobial
Authorized
2011-04-06
Revised: March 2016 AN: 00632/2015 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pharmasin 100 % w/w Granules for Use in Drinking Water for Pigs, Chickens, Turkeys and Calves. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1.1 g of granules contains Active substance: 1000 mg of tylosin (equivalent to 1100 mg of tylosin tartrate) 3. PHARMACEUTICAL FORM Granules for use in drinking water. White to light yellow coloured granules. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves, pigs, chickens, turkeys 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Calves: Treatment and prevention of pneumonia caused by _ Mycoplasma spp _ when the disease has been established in the herd. Pigs: Treatment and prevention of enzootic pneumonia caused by _Mycoplasma _ _hyopneumoniae_ and _Mycoplasma hyorhinis _when the disease has been established in the herd. Treatment and prevention of Porcine Intestinal Adenomatosis (Ileitis) associated with _Lawsonia intracellularis _when the disease has been established in the herd. Chickens: Treatment and prevention of chronic respiratory diseases (CRD) caused by _Mycoplasma _ _gallisepticum_ and _Mycoplasma _ _synoviae _ when the disease has been established in the flock. Treatment and prevention of necrotic enteritis caused by _Clostridium perfringens_ when the disease has been established in the flock Turkeys: Treatment and prevention of infectious sinusitis caused by _Mycoplasma _ _gallisepticum. _when the disease has been established in the flock Revised: March 2016 AN: 00632/2015 Page 2 of 6 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to tylosin or other macrolides. Do not use in cases of known resistance to tylosin or cross-resistance to other macrolides (MLS-resistance). Do not use in animals vaccinated with tylosin-sensitive vaccines either at the same time or within 1 week previously. Do not use in animals with hepatic disorders. Do not use in horses because of danger for inflammation of the caecum. 4.4 S Read the complete document