Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TYLOSIN
BIOVET Joint Stock Company
QJ01FA90
TYLOSIN
200 Mg/Ml
Solution for Injection
POM
Bovine, Caprine, Ovine, Porcine
Tylosin
Antibacterial
Authorised
2013-05-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT TYLOSIN BIOVET JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Tylosin 200,000 IU/ml Excipients: Benzyl alcohol (E1519) 40 mg/ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A pale yellow to amber-coloured liquid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep, goats, pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Infections caused my microorganisms susceptible to tylosin. CATTLE (ADULT): - Treatment of respiratory infections, metritis caused by Gram-positive micro-organisms, mastitis caused by _Streptococcus _spp., _Staphylococcus _spp. or _Mycoplasma _and interdigital necrobacillosis, i.e. panaritum or foot rot. CALVES: - Treatment of respiratory infections and necrobacillosis. PIGS: - Treatment of enzootic pneumonia, haemorrhagic enteritis, erysipelas and metritis. - Treatment of arthritis caused by _Mycoplasma _and _Staphylococcus _spp. SHEEP AND GOATS: - Treatment of respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by Gram+ microorganisms or _Mycoplasma _spp. 4.3 CONTRAINDICATIONS Do not administer to horses. Intramuscular injection can be fatal in chickens and turkeys. Do not administer to animals with a known hypersensitivity to tylosin or other macrolides. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 08/04/2016_ _CRN 7022886_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Due to likely variability (time, geographical) in susceptibility of bac Read the complete document