מדינה: רומניה
שפה: אנגלית
מקור: HMA (Heads of Medicines Agencies)
mycoplasma hyopneumoniae 1 RP
Pfizer GmbH
QI09AB13
Suspension for injection
Mycoplasma vaccine
Pigs Food
2011-12-08
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn MH-One Emulsion for injection for pigs Suvaxyn M.Hyo Mono (France and Denmark) Emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative composition Quantitative composition (2.0 ml dose) ACTIVE SUBSTANCES: Inactivated _Mycoplasma _ _hyopneumoniae_, strain P-5722- 3 RP * (undiluted) 1.00 ADJUVANTS: Carbopol #941 4.00 mg Squalane ** 3.24 mg EXCIPIENTS: Thiomersal 0.20 mg * Relative Potency unit determined by ELISA antigen quantification (_in vitro_ potency test) of undiluted serials compared to a reference vaccine. ** As component of MetaStim (that also contains Pluronic L-121 and Polysorbate 80). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Brownish-gray emulsion for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs of a minimum age of 7 days. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs of a minimum age of 7 days to reduce lung lesions that are caused by _Mycoplasma hyopneumoniae. _ Onset of immunity: 2 weeks following vaccination. Duration of immunity: 6 months. 2 4.3 CONTRA-INDICATIONS See section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Administer only to animals in good health. Avoid stress in the animals around the time of vaccination. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMIN קרא את המסמך השלם
1 A PPENDIX 1 S UMMARY OF P RODUCT C HARACTERISTICS 2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn MH-One (all countries, except for France and Denmark) Emulsion for injection for pigs Suvaxyn M.Hyo Mono (France and Denmark) Emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative composition Quantitative composition (2.0 ml dose) ACTIVE SUBSTANCES: Inactivated _Mycoplasma _ _hyopneumoniae_, strain P-5722-3 RP * (undiluted) 1.00 ADJUVANTS: Carbopol #941 4.00 mg Squalane ** 3.24 mg EXCIPIENTS: Thiomersal 0.20 mg * Relative Potency unit determined by ELISA antigen quantification (_in vitro_ potency test) of undiluted serials compared to a reference vaccine. ** As component of MetaStim (that also contains Pluronic L-121 and Polysorbate 80). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Brownish- gray emulsion for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs of a minimum age of 21 days. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs of a minimum age of 21 days to reduce lung lesions that are caused by _Mycoplasma hyopneumoniae. _ Onset of immunity: 4 weeks following vaccination. Duration of immunity: 6 months. 4.3 CONTRA-INDICATIONS See section 4.7. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Administer only to animals in good health. קרא את המסמך השלם