Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Mycoplasma hyopneumoniae strain p-5722-3
Elanco Animal Health, Eli Lilly and Company Limited
QI09AB13
Mycoplasma hyopneumoniae strain p-5722-3
Not Currently Available
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
mycoplasma
Immunological
Authorised
2011-01-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT STELLAMUNE MYCOPLASMA 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains ACTIVE SUBSTANCE Inactivated_ Mycoplasma hyopneumoniae_ at least 10,529 RU* at release to ensure 6000 RU* throughout shelf-life. * = Relative ELISA Units ADJUVANTS Liquid paraffin 0.09 ml EXCIPIENTS Thiomersal 0.185 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Emulsion for injection 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Fattening pigs from one week of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of fattening pigs to reduce lung lesion scores caused by_ Mycoplasma hyopneumoniae_ infection. Protection against_ Mycoplasma hyopneumoniae_ reduces the impact of secondary bacterial infection with _Pasteurella multocida_, offering improved health and economic benefits. Immunity is acquired two weeks following the second vaccination and protection lasts throughout the fattening period. 4.3 CONTRAINDICATIONS The use of immunosuppressant drugs or procedures is contraindicated within one month of vaccination. 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_ _ _ _1_ _1_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _0_ _7_ _8_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy animals. In any animal population, a small number of individuals may fail to respond fully to vaccinat Citiți documentul complet