SPIROVAC

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

INACTIVATED LEPTOSPIRA BORGPETERSENII SEROVAR HARDJO

제공처:

Pfizer Healthcare Ireland

ATC 코드:

QI02AB03

약제 형태:

Suspension for Injection

치료 그룹:

Immunological

치료 영역:

Bovine

승인 날짜:

2008-03-14

제품 특성 요약

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