Spirovac

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Inactivated leptospira borgpetersenii serovar hardjo type hardjobovis

Available from:

Zoetis Belgium S.A.

ATC code:

QI02AB03

INN (International Name):

Inactivated leptospira borgpetersenii serovar hardjo type hardjobovis

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

LR: Licensed Retailer as defined in national legislation

Therapeutic group:

Cattle

Therapeutic area:

leptospira

Therapeutic indications:

Immunological

Authorization status:

Authorised

Authorization date:

2014-02-28

Summary of Product characteristics

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