A suspension for injection containing per 2 ml dose inactivated Leptospira borgpetersenii serovar Hardjo type hardjobovis vaccine containing (≥ 2RP*), the adjuvant aluminium hydroxide (3.0 to 3.6 mg aluminium), and the excipients formaldehyde (<1 mg) and thiomersal (max. 0.01 %w/v). *RP = ELISA Relative Potency

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 week onset of immunity and 12 month duration of protection has been demonstrated by challenge with Leptospira borgpetersenii serovar Hardjo type hardjobovis.

For active immunisation of cattle persistently infected with Leptospira borgpetersenii serovar Hardjo type hardjobovis. Vaccination reduces urinary shedding of Leptospira borgpetersenii serovar Hardjo type hardjobovis 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.

2 ml

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

2 doses of vaccine separated by a 4 to 6 week interval. Calves as young as 4 weeks of age may be vaccinated.

A single 2 ml dose on an annual basis.

A diffuse and oedematous swelling up to 10 cm in diameter, sometimes sensitive to palpation, could occur in up to 40% of animals and can last for up to 66 days after completion of vaccination. The reaction to subsequent vaccinations and the reaction in pregnant animals are more marked. The injection site reaction may be sensitive to palpation the week following vaccination and may persist as a hard nodule for several weeks.

No adverse drug reactions other than those listed above occurred after administration of twice the normal dose. As part of the natural response following vaccination, and following an overdose of twice the maximum dose of the vaccine, a reactive lymphadenopathy in the local lymph node as well as production of a subcutaneous, granulomatous, inflammatory reaction could be visible under the skin for at least 2 months. The total duration of this reaction in the underlying tissues is not known.

The swelling is more marked in pregnant animals. A diffuse swelling of up to 22 cm in diameter can occur following the second injection. This swelling is more marked in pregnant animals especially in their third trimester.

Vaccinated cattle may be positive for diagnostic tests for leptospirosis and therefore unacceptable for export to some countries.

Zero days.

Even though animals may have been vaccinated, the risk of transmission of leptospirosis from cattle to their handlers, albeit very much reduced, remains. Appropriate precautions should be maintained at all times and prompt medical advice sought in the event of clinical signs of possible infection.

Store and transport refrigerated (2 - 8°C). Do not freeze. Protect from light.

Once the immediate packaging has been opened, the contents should be used within 10 hours.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Do not mix with any other veterinary medicinal product.

Any unused product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

For animal treatment only.

Keep out of reach and sight of children.

Packs containing 5 doses (10 ml) or 25 doses (50 ml). Not all pack sizes may be marketed.

Spirovac can be used during pregnancy and lactation.

Vaccination induces humoral antibody response and cell-mediated immunity as measured by serology and gamma-interferon production. A marked, statistically significant difference is also seen in the anamnestic response following a single booster vaccination or infection (challenge) 12 months after primary vaccination.

A strong serological cross-reactivity post vaccination has been demonstrated against Leptospira interrogans serovar Hardjo, a closely related species in the same serovar. This was sustained for at least 12 months following primary vaccination, and is also seen in the anamnestic response following a single booster vaccination. A challenge model is not available to document protection.