Zulvac 1 Ovis - Patient leaflet, side effects, dosage

X

• 9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

• 10. EXPIRY DATE

EXP {month/year}

Once broached use immediately.

• 11. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Protect from light.

Do not freeze.

• 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED P MATERIALS, IF ANY

Disposal: read package leaflet.

--

• 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
  
  RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE

  For animal treatment only. To be supplied only on veterinary prescription.

  
  

EU/2/11/131/001

EU/2/11/131/005

EU/2/11/131/006

NUFACTURER’S BATCH NUMBER

Lot {number}

EXP {month/year}

PACKAGE LEAFLET:

Zulvac 1 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. Camprodon s/n „la Riba“

17813 Vall de Bianya

Girona

SPAIN

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zulvac 1 Ovis suspension for injection for sheep

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

Each 2 ml dose contains:

Active substance:

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

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

Adjuvant:

Excipient:

Off-white or pink liquid.

For active immunisation of sheep from 1 and a half months of age for the prevention of viraemia caused by Bluetongue Virus (BTV), serotypes 1.

*(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

None.

■

• 6. ADVERSE REACTIONS

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

Vaccination may be followed very commonly 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, inclu ing 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 Q

Sheep

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

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

Revaccination:

Any revaccination 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.

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.

• 10. WITHDRAWAL PERIOD(S)

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 label after EXP.

Once broached use immediately.

• 12. SPECIAL WARNING(S)

Vaccinate only healthy animals.

CX

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

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.

Pregnancy:

Can be used during pregnancy.

Lactation:

No data is available on safety in lactating animals. The use in lactating animals is therefore not recommended.

,O

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 Bluetongue virus (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

.               Xx

• 15. OTHER INFORMATION