Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
tylosin tartrate
Franklin Pharmaceuticals Ltd.
QJ01FA90
200 Mg/Ml
Solution for Injection
Porcine
Antibacterial
Authorised
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tyloject 200 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. A clear, yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is specifically formulated for the treatment and prevention of infections caused by organisms sensitive to Tylosin e.g. _Spirochaetes, Leptospira, Actinomyces, Mycoplasmas, Haemophilus pertussis. Moraxella bovis,_ _Streptococci spp., Neissieria spp_. and some Gram negative bacteria. It is also effective against some _Mycoplasmas,_ _Chlamydiae _and _Rickettsiae._ The product is recommended for use in the treatment of a wide range of common respiratory and genito-urinary tract, otitis, cellulitis and secondary bacterial conditions associated with viral disease or postoperative infections in pigs. 4.3 CONTRAINDICATIONS Do not use in very young animals. This product contains Benzyl Alcohol, which has been documented to cause adverse reactions in neonates. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Oedema of the anal mucosa, partial anal protrussion, erythema and prutitis have occasionally been reported following medication in pigs. This product contains Benzyl Alcohol which has been documented to cause adverse reactions in neonates. Hence the product should not be used in young animals. Each ml contains: Active substance Tylosin tartrate 200 mg Excipients Benzyl alcohol 10 mg For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/04/2011_ _CRN 7010617_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR US Olvassa el a teljes dokumentumot