Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Tylosin
Huvepharma N.V.
QJ01FA90
Tylosin
Granules
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Antimicrobial
Authorized
2009-11-04
Revised: July 2020 AN: 01504/2019 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pharmasin 20 000 IU/g Oral Granules for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: Active substance: Tylosin (as tylosin phosphate) : 20 000 IU Excipients: For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Granules Light tan coloured, free flowing granules. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES) Pigs: - Treatment and metaphylaxis of clinical signs of porcine proliferative enteritis (porcine intestinal adenomatosis, proliferative hemorrhagic enteropathy, ileitis) associated with Lawsonia intracellularis when the disease has been diagnosed at the group level. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance and/or to any of the excipients of the product. Do not use in animals with known hypersensitivity 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. Revised: July 2020 AN: 01504/2019 Page 2 of 5 4.4 SPECIAL WARNINGS (FOR EACH TARGET SPECIES) None. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals This product is only for administration in small quantities of feed for immediate consumption, to individual 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 susceptibility of bacteria for tylosin, bacteriological sampling and susceptibility testing are recommended. Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to Tylosin and other macrolid Read the complete document