Zulvac SBV - Patient leaflet, side effects, dosage

3B

PACKAGE LEAFLET:

Zulvac SBV suspension for injection for cattle and 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 SBV suspension for injection for cattle and sheep

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

  Active substance: Inactivated Schmallenberg virus, strain BH80/11–4	Amount per 2 ml dose (cattle) RP* > 1	Amount per 1 ml dose (sheep) RP* > 1
  Adjuvants:
  Aluminium hydroxide	385.2 mg (4 mg Al3+)	192.6 mg (2 mg Al3+)
  Quil-A (Quillaja saponaria saponin extract)	0.4 mg	0.2 mg
  Excipient:
  Thiomersal	0.2 mg	0.1 mg

Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.

Off-white or pink liquid.

Cattle:

For active immunisation of cattle from 3.5 months of age to reduce viraemia associated with infection by Schmallenberg vi­rus.

Onset of immunity: 2 weeks after completion of the primary vaccination course.

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

Sheep:

For active immunisation of sheep from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg vi­rus.

Onset of immunity: 3 weeks after vaccination.

Duration of immunity: 6 months after vaccination.

Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 8 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.

• *Below the level of detection by the validated RT-PCR method at 3.6 log10 RNA copies/ml of plasma for cattle and at 3.4 log10 RNA copies/ml of plasma for sheep.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

Cattle :

A transient increase in rectal temperature, not exceeding 1.5 °C, was very commonly observed during the first 48 hours after vaccination. Local reactions at the injection site in the form of small intramuscular granulomas up to 0.7 cm in diameter which resolve in a maximum of 10 days, also very commonly appeared in the safety studies conducted.

Sheep:

A transient increase in rectal temperature, not exceeding 1.5 °C, was very commonly observed during the first 24 hours after vaccination. Local reactions at the injection site in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm also very commonly appeared in the safety studies conducted. The reactions were observed for at least 47 days in the form of diffuse swelling of less than 2 cm diameter.

Pregnant ewe:

A transient increase in rectal temperature, not exceeding 0.8 °C, was very commonly observed during the first 4 hours after vaccination. Local reactions at the injection site in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm also very commonly appeared in the safety studies conducted. The reactions were observed for at least 97 days in the form of small granulomas of less than 0.5 cm in diameter.

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

Cattle and sheep.

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

Cattle:

Intramuscular use (in the neck).

Primary vaccination:

• – For cattle from 3.5 months of age: administer two doses of 2 ml three weeks apart.

Booster vaccination :

• – Administer two doses of 2 ml three weeks apart, every twelve months.

Sheep:

Subcutaneous use (in the axillar region behind the elbow).

Primary vaccination:

• – For sheep from 3.5 months of age: administer one dose of 1 ml.

• – For female sheep at breeding age: administer one dose of 1 ml at least 14 days prior to breeding.

Booster vaccination:

• – For non-breeding sheep: administer one dose of 1 ml, every 6 months.

• – For female breeding sheep: administer one dose of 1 ml at least 14 days prior to every breeding.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake the vial before use.

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

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

Shelf life after first opening the container: use immediately.

• 12. SPECIAL WARNING(S)

Vaccinate healthy animals only.

Special warnings for each target species:

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:

Sheep: Safety data are available to demonstrate the safety of the vaccine when administered to pregnant sheep. Can be used at 2 months of pregnancy and onwards.

Cattle: The safety and efficacy of the vaccine has not been established in pregnant cattle.

Lactation:

The safety and the efficacy of the vaccine have not been established in lactating animals.

Fertility :

The safety and the efficacy of the vaccine have not been established in breeding males.

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.

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 to protect the environment.

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