País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
INACTIVATED LEPTOSPIRA BORGPETERSENII SEROVAR HARDJO
Pfizer Healthcare Ireland
QI02AB03
Suspension for Injection
Immunological
Bovine
2008-03-14
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 demonstrated. The vaccination may not prevent abortion in cows in which placental infection has already occurred. 4.3 CONTRAINDICATIONS None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/10/2011_ _CRN 7007861_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinated cattle may be positive in diagnostic tests for leptospirosis and therefore unacceptable for export to some countries. 4.5 SPECIAL Llegiu el document complet