Zulvac SBV (Inactivated Schmallenberg virus, strain...) – Summary of product characteristics - QI02AA

Updated on site: 09-Feb-2018

Medication name: Zulvac SBV
ATC: QI02AA
Substance: Inactivated Schmallenberg virus, strain BH80/11-4
Manufacturer: Zoetis Belgium SA

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

ZULVAC SBV suspension for injection for cattle and sheep

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Amount per 2 ml dose

Amount per 1 ml dose

 

(cattle)

(sheep)

Inactivated Schmallenberg virus,

RP* ≥ 1

RP* ≥ 1

 

 

Adjuvants:

385.2 mg (4 mg Al3+)

192.6 mg (2 mg Al3+)

Aluminium hydroxide

Saponin

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

For the full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Suspension for injection.

Off-white or pink liquid.

4.CLINICAL PARTICULARS

4.1Target species

Cattle and sheep.

4.2Indications for use, specifying the target species

Cattle:

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

Onset of immunity: 14 days after completion of the primary vaccination course. Duration of immunity: 12 months 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: 21 days after vaccination.

Duration of immunity: 6 months after vaccination.

Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 4.9 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.

4.3Contraindications

None.

4.4Special warnings for each target species

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

4.5Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals.

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.

4.6Adverse reactions (frequency and seriousness)

In cattle, a transient increase in rectal temperature, not exceeding 1.5 °C, may very commonly occur during the 48 hours following vaccination. Local reactions may very commonly appear in the vaccinated animals in the form of small intramuscular granulomas up to 0.7 cm of diameter, which resolve in a maximum of 10 days.

In sheep, a transient increase in rectal temperature, not exceeding 1.5 ºC, may very commonly occur during the first 24 hours after vaccination. Local reactions may very commonly appear in the vaccinated animals in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm. The reactions may last for at least 47 days in the form of diffuse swelling of less than 2 cm diameter.

In pregnant ewes, a transient increase in rectal temperature, not exceeding 0.8 ºC, may very commonly occur during the first 4 hours after vaccination. Local reactions may very commonly appear in the vaccinated animals in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm. The reactions may persist for at least 97 days in the form of small granules of less than 0.5 cm of diameter.

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

-very common (more than 1 in 10 animals displaying adverse reactions 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).

4.7Use during pregnancy, lactation or lay

Pregnancy:

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

Cattle: The safety and efficacy of the vaccine have not been established during pregnancy.

Fertility:

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

Lactation:

The safety and the efficacy of the vaccine have not been established during lactation.

4.8Interaction 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.

4.9Amounts to be administered and administration route

Shake the vial before use.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Not applicable.

4.11 Withdrawal period(s)

Zero days.

5.IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for bovidae, inactivated viral vaccines for cattle. ATCvet code: QI02AA.

To stimulate active immunity against Schmallenberg virus in cattle and sheep.

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Aluminium hydroxide

Saponin

Thiomersal

Potassium chloride

Potassium dihydrogen phosphate

Disodium phosphate dihydrate

Sodium chloride

Water for injections

6.2Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 1 year.

Shelf life after first opening the immediate packaging: use immediately.

6.4.Special precautions for storage

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

Do not freeze.

6.5Nature and composition of immediate packaging

Cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7.MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/14/178/001

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 06/02/2015

10.DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Comments