Страна: Франция
Язык: английский
Источник: HMA (Heads of Medicines Agencies)
Inactivated Haemophilus Parasuis 3.4 IU, Inactivated Haemophilus Parasuis 8.1 IU
Fort Dodge Animal Health
QI09AC
Suspension for injection
Inactivated bacterial vaccines and antisera
Pigs
2012-02-23
Revised: November 2012 AN: 02051/2011 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn M.hyo – Parasuis, suspension for injection for pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES PER 2 ML DOSE Inactivated _Mycoplasma hyopneumoniae_, strain P-5722-3 RP * 1 – 1.9 Inactivated _Haemophilus parasuis_ serotype 4, strain 2170B RP * 1 – 8.1 Inactivated _Haemophilus parasuis_ serotype 5, strain IA84-29755 RP * 1 – 3.4 * Relative potency as compared to a reference in an in-vitro ELISA assay ADJUVANT: Carbopol 941 4.0 mg EXCIPIENTS: Thiomersal 0.2 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Semi-transparent, homogeneous, pale red solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (fatteners). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of pigs to reduce lung lesions caused by _Mycoplasma hyopneumoniae_ and to reduce lesions and clinical signs caused by _Haemophilus parasuis_ serotypes 4 and 5. Onset of immunity against _Mycoplasma hyopneumoniae_ has been demonstrated one week after second vaccination. Onset of immunity against _Haemophilus parasuis_ serotype 4 and 5 has been demonstrated 3.5 weeks after second vaccination. Duration of immunity studies indicate that the vaccine protects for 6 months after the second vaccination against _Mycoplasma hyopneumoniae_ and _Haemophilus parasuis_ serotypes 4 and 5. Revised: November 2012 AN: 02051/2011 Page 2 of 4 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The efficacy of the _H. parasuis_ components of the vaccin Прочитать полный документ