Ország: Franciaország
Nyelv: angol
Forrás: HMA (Heads of Medicines Agencies)
leptospira Hardjo 1 IU
Pfizer Limited
QI02AB03
Injection
Leptospira vaccine
Cattle
2011-07-21
Revised: October 2011 AN: 00139/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Spirovac_ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) of Spirovac contains the following: ACTIVE SUBSTANCES: Inactivated _Leptospira borgpetersenii_ serovar Hardjo ≥ 2RP* * RP = ELISA RELATIVE POTENCY. ADJUVANT Aluminium hydroxide 3.0 to 3.6 mg of aluminium EXCIPIENTS Formaldehyde <1 mg Thiomersal max 0.01% (w/v) See Section 6.1 for full list of excipients. 3. PHARMACEUTICAL FORM Suspension for injection. Slightly coloured turbid liquid which might contain a loose sediment. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle from 4 weeks of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation - of cattle to prevent kidney colonisation and shedding of _Leptospira _ _ borgpetersenii _serovar Hardjo_ _in urine; a 3 weeks onset of immunity and 12 months duration of protection have been demonstrated by challenge with _Leptospira borgpetersenii _serovar Hardjo. - of cattle persistently infected with _Leptospira borgpetersenii _serovar Hardjo: to reduce urinary shedding of _Leptospira borgpetersenii _serovar Hardjo without clearance of renal colonisation; this effect appears 4 weeks post vaccination and its duration is unknown. The epidemiological significance of the reduced shedding has not been de Olvassa el a teljes dokumentumot