Zulvac 1+8 Ovis - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zulvac 1+8 Ovis suspension for injection for sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 2 ml of vaccine contains:

Active substances:

Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1         RP* > 1

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.

Adjuvants:

Aluminium hydroxide

Saponin

Excipients:

Thiomersal

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection. Off-white or pink liquid.

4. CLINICAL PARTICULARS4.1 Target species

Sheep

• 4.2 Indications for use, specifying the target species

Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by

Bluetongue virus, serotypes 1 and 8.

• *(Cycling value (Ct) > 36 by a validated RT-PCR method, indicating no presence of viral genome).

Onset of immunity: 21 days after completion of the primary vaccination scheme.

Duration of immunity: 12 months after completion of the primary vaccination scheme.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species 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.

• 4.5 Special 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

Not applicable.

• 4.6 Adverse reactions (frequency and seriousness)

A transient increase in rectal temperature, not exceeding 1.2 °C, may occur commonly during the 24 hours following vaccination.

Vaccination 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 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days).

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)

• 4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy.

No data are available on safety in lactating animals.

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 Bluetongue virus (BTV).

4.8 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.

• 4.9 Amounts to be administered and administration route

Subcutaneous use.

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.

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.

Avoid multiple vial broaching.

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.

Revaccination:

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

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

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).

• 4.11 Withdrawal period(s)

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated viral vaccines for sheep, Bluetongue virus.

ATCvet code: QI04AA02.

To stimulate active immunity against Bluetongue virus, serotypes 1 and 8 in sheep.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Aluminium hydroxide

Saponin

Thiomersal

Potassium chloride

Potassium dihydrogen phosphate

Disodium hydrogen phosphate dodecahydrate

Sodium chloride

Water for injections.

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

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

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

6.4. Special precautions for storage

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

Protect from light.

Do not freeze.

• 6.5 Nature and composition of immediate packaging

High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.

Pack sizes:

Pack of 1 bottle of 10 doses (20 ml).

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.

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

7. MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/11/120/001–003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14/03/2011.

Date of last renewal: 07/01/2016