Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
INACTIVATED WHOLE CELL CONCENTRATE OF M. HYOPNEUMONIAE STRAIN 11
Intervet Ireland Limited
QI09AB13
INACTIVATED WHOLE CELL CONCENTRATE OF M. HYOPNEUMONIAE STRAIN 11
Unknown
Emulsion for Injection
POM
Porcine
Mycoplasma vaccine
Immunological - Inactivated vaccine
Authorised
2012-01-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis M Hyo ID ONCE emulsion for injection for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.2 ml contains: ACTIVE SUBSTANCE: _Mycoplasma hyopneumoniae_ inactivated_,_ strain 11: 6.5 log 2 Ab titre* * Mean antibody titre (Ab) obtained after inoculation of mice with a 1/1,000 pig dose. ADJUVANT: light liquid paraffin 34.6 mg dl- -tocopheryl acetate 2.5 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emulsion for injection. White to nearly white emulsion with creamy appearance after shaking. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of pigs to reduce pulmonary lesions and the decrease in daily weight gain during the finishing period due to infection caused by_ Mycoplasma hyopneumoniae_. Onset of immunity: 3 weeks after vaccination. Duration of immunity: 22 weeks after vaccination. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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_ _0_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _7_ _6_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate healthy animals only. Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user: This Olvassa el a teljes dokumentumot