Zulvac 8 Ovis Suspension for injection for Sheep 100ml (50 doses)

Zulvac 8 Ovis Suspension for injection for sheep 100ml.

Uses

Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by Bluetongue Virus, serotype 8.

*(Cycling value (Ct) = 36 by a validated RT-PCR method, indicating no presence of viral genome).
Onset of immunity: 25 days after administration of the second dose.

The duration of immunity is at least 1 year after the primary vaccination course.

Dosage and administration

Subcutaneous use.

Apply using aseptic procedures.

Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of injection. The entire content of the bottle should be used immediately after broaching and during the same procedure. Avoid multiple vial broaching.

Administer one dose of 2 ml according to the following vaccination scheme:

1st injection: from 1.5 months of age.

2nd injection: after 3 weeks.

Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.

Advice on correct administration

In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi-injection type vaccination system when larger dose presentations are used.

Contra-indications, warnings, etc

Only use in healthy animals.

Use in other domestic and wild ruminant species that are considered at risk of infection should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. The level of efficacy for other species may differ from that observed in sheep.

No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.

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.

Can be used during pregnancy.

The safety and the efficacy of the vaccine have not been established in breeding males. In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against BTV.

In one laboratory safety study, transient increase in rectal temperature during the 24 hours following vaccination not exceeding 1.2°C and local reaction at the injection site, in most cases in the form of a general swelling (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days) were observed very commonly. These clinical signs have been reported very rarely from the field.

A transient increase in rectal temperature, not exceeding 0.6°C, may occur during the 24 hours following administration of a two-fold overdose.

Administration of a two-fold overdose may be followed in most animals by a local reaction at the injection site. These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 63 days).

The frequency of adverse reactions is defined using the following convention:

• very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
• common (more than 1 but less than 10 animals in 100 animals)
• uncommon (more than 1 but less than 10 animals in 1,000 animals)
• rare (more than 1 but less than 10 animals in 10,000 animals)
• very rare (less than 1 animal in 10,000 animals, including isolated reports)If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Withdrawal period

Zero days.

Pharmaceutical precautions

For animal treatment only.

Keep out of the sight and reach of children.

Store and transport refrigerated (2ºC - 8ºC).

Protect from light. Do not freeze.

Once broached use immediately.

Legal category

 POM-V

Packaging quantities

Pack of 1 bottle of 50 doses (100 ml).
Pack of 1 bottle of 120 doses (240 ml).

Not all pack sizes may be marketed.

Further information

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