Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Inactivated leptospira borgpetersenii serovar hardjo type hardjobovis
Zoetis Belgium S.A.
QI02AB03
Inactivated leptospira borgpetersenii serovar hardjo type hardjobovis
.
Suspension for injection
LR: Licensed Retailer as defined in national legislation
Cattle
leptospira
Immunological
Authorised
2014-02-28
Health Products Regulatory Authority 04 September 2017 CRN000V0F Page 1 of 5 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 hydroxide3.0 to 3.6 mg of aluminium EXCIPIENTS Formaldehyde<1 mg Thiomersalmax 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 reduce kidney colonisation and shedding of _Leptospira borgpetersenii _ serovar Hardjo type hardjobovis to the extent that no viable organisms can be detected by culture in the urine of vaccinated animals after challenge; a 3 weeks onset of immunity and 12 months duration of protection have been demonstrated by challenge with _Leptospira borgpetersenii _serovar Hardjo type hardjobovis. - of cattle persistently infected with _Leptospira borgpetersenii _serovar Hardjo type hardjobovis: to reduce urinary shedding of _Leptospira borgpetersenii _serovar Hardjo type hardjobovis withoutclearance of renal colonisation; this effect appears 4 weeks post vaccination and its duration is unknown.The epidemiological significance of the Health Products Regulatory Authority 04 September 2017 CRN000V0F Page 2 of 5 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. 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 PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PER Прочитайте повний документ