Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Tylosin
Huvepharma N.V.
Pharmaco
Tylosin
Premix for medicated feeding stuff
POM-V - Prescription Only Medicine – Veterinarian
Chickens, Pigs
Antimicrobial
Authorized
2009-11-04
Revised: July 2020 AN: 01504/2019 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pharmasin 100 000 IU/g Premix for medicated feeding stuff for pigs, broilers and pullets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: Active substance: Tylosin (as tylosin phosphate) : 100 000 IU Excipients: For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff. Light tan coloured, free flowing granules. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs, broilers and pullets. 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) Pigs: - Treatment and metaphylaxis of Porcine Intestinal Adenomatosis (PIA) associated with _Lawsonia intracellularis _when the disease has been diagnosed at the group or herd level. Broilers and pullets: - Treatment and metaphylaxis of respiratory infections caused by _Mycoplasma gallisepticum_ and _Mycoplasma synoviae, _when the disease has been diagnosed in the flock. - Treatment and metaphylaxis of necrotic enteritis caused by _Clostridium perfringens_, when the disease has been diagnosed in the flock. Revised: July 2020 AN: 01504/2019 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use in animals with known sensitivity to the active substance and/or to any of the excipients of the veterinary medicinal product. Do not use in animals with known hyper sensitivity to tylosin and other macrolides. Do not use where cross-resistance to other macrolides (MLS-resistance) is suspected. 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. Danger of inflammation of the cecum. 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) None. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Animals with acute infections may have a reduced feed intake and should be treated with a suitable injectable product first. ‘Due to likely variability (time, geographical) in suscept Read the complete document