Syvazul BTV suspension for injection for sheep and cattle – patient leaflet, side effects, dosage

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

Marketing authorisation holder:

LABORATORIOS SYVA, S.A.U.

Av. Párroco Pablo Diez, 49-57

24010 LEÓN

SPAIN

Manufacturer responsible for batch release:

LABORATORIOS SYVA, S.A.U.

Parque Tecnológico de León

Av. Portugal s/n

Parcelas M15-M16

24009 LEÓN

SPAIN

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Syvazul BTV suspension for injection for sheep and cattle

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

Each ml contains:

Active substances*:

Inactivated bluetongue virus (BTV) RP** > 1

* Maximum of two different inactivated bluetongue virus serotypes:

Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1

Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004

Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01

* * Relative potency measured by ELISA in relation to a reference vaccine whose efficacy has been demonstrated by challenge in the target species.

The number and type(s) of strains included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.

Adjuvants:

Aluminium hydroxide (Al³⁺)

2.08 mg 0.2 mg

Semi-purified saponin from Quillaja saponaria

Excipient:

Thiomersal

0.1 mg

Pinkish-white suspension for injection easily homogenised by shaking.

4. INDICATION(S)

Sheep:

For active immunisation of sheep to prevent viraemia* and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/ or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).

*Below the level of detection by the validated RT-PCR method at 1.32 log10 TCID50/ml

Onset of immunity: 39 days after completion of the primary vaccination scheme.

Duration of immunity: one year after completion of the primary vaccination scheme.

Cattle:

For active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1 and/ or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).

*Below the level of detection by the validated RT-PCR method at 1.32 log10 TCID50/ml

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

Duration of immunity: one year after completion of the primary vaccination scheme.

5. CONTRAINDICATIONS

None.

6. ADVERSE REACTIONS

The development of local reactions is very common at the site of injection after vaccination.

Erythema associated with mild to moderate oedema is very common from 1 to 6 days after the administration.

A painless nodule that may reach up to 3.8 cm diameter in sheep and 7 cm diameter in cattle develops very commonly after 2 to 6 days and diminishes progressively over time.

An abscess may appear on rare occasions.

Most local reactions disappear or become residual (< 1cm) before 70 days in sheep and 30 days in cattle, although residual nodules can persist after that time.

A transient increase in rectal temperature, not exceeding 2.3 °C, during the 48 hours following vaccination, is very common.

The following might be observed on rare occasions in sheep and on very rare occasions in cattle:

• Reproductive system disorders: abortion, perinatal mortality or premature parturition
• Systemic disorders: apathy, recumbency, fever, anorexia or lethargy.

The following might be observed on very rare occasions in sheep and cattle:

• Reduction in milk production
• Neurological disorders: paralysis, ataxia, blindness or incoordination
• Respiratory tract disorders: pulmonary congestion, dyspnoea
• Digestive tract disorders: rumen atony or bloating
• Hypersensitivity reactions: with hypersalivation
• Death.

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 and cattle.

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

Shake well before use.

Sheep:

Subcutaneous use.

Administer subcutaneously to sheep from 3 months of age, according to the following scheme:

• Primary vaccination: administer a single 2 ml dose
• Revaccination: administer one dose of 2 ml after 12 months.

Cattle:

Intramuscular use.

Administer intramuscularly to cattle from 2 months of age in naïve animals or from 3 months of age in calves born to immune cattle, according to the following scheme:

• Primary vaccination: administer two doses of 4 ml 3 weeks apart
• Revaccination: administer one dose of 4 ml after 12 months.

9. ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

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).

Do not freeze.

Protect from light.

Store in the original package.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP. The expiry date refers to the last date of that month.

Shelf life after first opening the immediate packaging: 10 hours.

12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate healthy animals only.

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 and cattle.

No information is available on the use of the vaccine in sheep with maternally-derived antibodies.

No information is available on the use of the vaccine containing BTV4 serotype in cattle 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.

People with known hypersensitivity to aluminium hydroxide, thiomersal or saponins should avoid contact with the veterinary medicinal product.

Pregnancy:

Can be used during pregnancy.

Lactation:

Can be used during lactation.

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):

After administration of a double dose, no other adverse reactions different to those mentioned in ‘ADVERSE REACTIONS’ were observed.

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

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

15. OTHER INFORMATION

Pack sizes:

Cardboard box with 1 vial containing 80 ml.

Cardboard box with 1 vial containing 200 ml.

Not all pack sizes may be marketed.

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.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien laboratorios syva, s.a.u. Av. Pârroco Pablo Diez, 49-57 ES-24010 Leon

Lietuva

laboratorios syva, s.a.u.

Av. Pârroco Pablo Diez, 49-57

ES-24010 Leon

TnX. 210 9851200

Latvija

laboratorios syva, s.a.u.

Av. Párroco Pablo Díez, 49-57

ES-24010 León

United Kingdom (Northern Ireland) laboratorios syva, s.a.u.

Av. Párroco Pablo Díez, 49-57

ES-24010 León

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