Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Tiamulin
Huvepharma NV
QJ01XQ01
Tiamulin
162 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Porcine
tiamulin
Antibacterial
Authorised
2009-10-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT VETMULIN 162 mg/ml Solution for Injection for pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Pale yellow oily solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment and metaphylaxis of swine dysentery caused by_ Brachyspira hyodysenteriae_. For the treatment of enzootic pneumonia caused by tiamulin-susceptible_ Mycoplasma_ _hyopneumoniae_ and mycoplasmal arthritis caused by tiamulin-susceptible_ Mycoplasma hyosynoviae._ 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active ingredient or any of the excipients. Do not use in cases of known resistance to tiamulin. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Inflammation/scarring may occur at the site of injection. For this reason, it is recommended that the product should be administered into the muscle of the neck. Each ml contains: ACTIVE SUBSTANCE Tiamulin 162 mg/ml EXCIPIENTS Butyl parahydroxybenzoate 0.324 mg/ml Propyl gallate (E310) 0.163 mg/ml For a full list of excipients, see section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _8_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _6_ _5_ _8_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Due to the likely variability (time, geographical) in the Прочитајте комплетан документ