Patient leaflet - Zulvac 1 Bovis
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 Bovis suspension for injection for cattle
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 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
RP* > 1
Adjuvants:
Aluminium hydroxide (Al3+)
Saponin
Excipient:
Thiomersal
Off-white or pink liquid.
4. INDICATIONS(S)
4 mg 0.4 mg
0.2 mg
For active immunisation of cattle from 2 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: 15 days after completion of the primary vaccination scheme.
Duration of immunity: 12 months after completion of the primary vaccination scheme.
5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS (7>
After first vaccination a rectal temperature increase of up to 1.6°C may occur very commonly the 3rd day after the injection. Rectal temperatures should then return to normal values.
After second and third vaccination a rectal temperature increase of up to 1.3°C and 2.8°C respectively may occur very commonly one day after the injection and then rectal temperatures return to normal values.
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
Cattle
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use.
Primary vaccination:
Administer one dose of 2 ml according to the following vaccination scheme:
1st injection: from 2.5 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 reachof 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.
No information is available on the use of the vaccine in animals 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 cattle.
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.
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).
Interactions with other medical 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 two-fold overdose a rectal temperature increase up to 2.1°C may occur 1 day after the injection and then rectal temperatures return to normal values.
A slight to moderate increase of local reactions may commonly be observed after a 2-fold overdose lasting for a maximum of 56 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 http://www.ema.europa.eu/
15. OTHER INFORMATION
Cardboard box with one type I glass vial of 20 ml (containing 10 doses) with a chlorobutyl rubber stopper and aluminium cap.
Cardboard box with one type II glass vial of either 100 ml (containing 50 doses) or 240 ml (containing 120 doses) with a chlorobutyl rubber stopper and aluminium cap.
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