Zulvac 8 Ovis - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Zulvac 8 Ovis suspension for injection for sheep

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

Manufacturer responsible for batch release :

Zoetis Manufacturing & Research Spain, S.L.

Ctra. de Camprodon, s/n°

Finca La Riba

Vall de Bianya

Gerona, 17813

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zulvac 8 Ovis suspension for injection for sheep

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

One dose of 2 ml of vaccine contains:

Active substance:

Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* > 1

Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.

Adjuvant(s):

Aluminium hydroxide (Al3+) 4 mg

Quil-A (Quillaja saponaria saponin extract) 0.4 mg

Excipient:

Thiomersal

Off-white or pink suspension for injection.

• 4. INDICATION(S)

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. Duration of immunity: at least 1 year after the primary vaccination course.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

A 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 in one laboratory safety study. These clinical signs have been reported very rarely from the field.

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

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Sheep.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Subcutaneous use.

Apply usual 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.

Primary vaccination:

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.

Re-vaccination:

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

• 9. ADVICE ON CORRECT ADMINISTRATION

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

• 10. WITHDRAWAL PERIOD

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C – 8 °C).

Protect from light.

Do not freeze.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and on the label after EXP.

Shelf-life after first opening the container: use immediately.

• 12. SPECIAL WARNING(S)

Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.

Special warnings for each target species:

Vaccinate healthy animals only.

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.

Special precautions for use in animals:

Not applicable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Pregnancy:

Can be used during pregnancy.

Fertility:

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.

Interaction with other medicinal products and other forms of interaction:

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.

Overdose (symptoms, emergency procedures, antidotes) :

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).

Incompatibili­ties:

Do not mix with any other veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ).

• 15. OTHER INFORMATION