Spirovac

1 x 5 dose

Suspension for injection

Active substance

Leptospira borgpetersenii (serotype Hardjo) (type hardjobovis) (attenuated)

ATC code

QI02AB03 Leptospira

QI02AB Inactivated bacterial vaccines (including Mycoplasma, Toxoid and Chlamydia)

QI02A Immunologicals for cattle

QI02 Immunologicals for bovidae

QI Immunologicals

Species

Cattle.

Indications

For active immunisation of cattle from 4 weeks of age 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.

Onset of immunity: 3 weeks.

Duration of immunity: 12 months (demonstrated by challenge with Leptospira borgpetersenii serovar Hardjo type hardjobovis).

For active immunisation of cattle from 4 weeks of age persistently infected with

Leptospira borgpetersenii serovar Hardjo type hardjobovis: to reduce urinary shedding of Leptospira borgpetersenii serovar Hardjo type hardjobovis without clearance of renal colonisation. The epidemiological significance of the reduced shedding has not been demonstrated.

Onset of immunity: 4 weeks.

Duration of immunity: unknown.

Dose to be administered and administration route

Dose: 2 ml.

Administration route:

Subcutaneous injection, preferably in the neck. Shake the container well before withdrawing the dose.

Vaccination scheme:

Basic vaccination scheme:

2 doses of vaccine separated by a 4 to 6 week interval, from 4 weeks of age.

Revaccination scheme:

A single 2 ml dose on an annual basis.

Adverse reactions

Cattle:

Very common

(>1 animal / 10 animals treated):

Injection site swelling^¹, Injection site nodule²

¹Diffuse and oedematous, up to 10 cm in diameter which can last for up to 66 days. May be sensitive to palpation the week following vaccination. The swelling is more marked in pregnant animals, particularly in their third trimester of pregnancy, and can be up to 22 cm in diameter following second injection.

²May persist for several weeks.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.