Patient leaflet - Zulvac 1+8 Bovis
B. PACKAGE LEAFLET
PACKAGE LEAFLET: Zulvac 1+8 Bovis Suspension for injection for cattle
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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
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 1+8 Bovis suspension for injection for cattle
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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
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 cattle.
Adjuvants:
4 mg (Al3+)
1 mg
0.2 mg
Aluminium hydroxide Saponin
Excipient:
Thiomersal
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4. INDICATION(S)
For active immunisation of cattle from 3 months of age for the prevention of viraemia caused by bluetongue virus (BTV), 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 course.
Duration of immunity: 12 months after completion of the primary vaccination course.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
A transient increase in rectal temperature, not exceeding 2.7 C, was commonly observed during the 48 hours following vaccination in field safety studies.
Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5cm diameter were commonly observed after administration of a single dose in field safety studies. These resolved within a maximum of 25 days. Local reactions may increase slightly following the second dose in this case lasting up to 15 days. Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
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)
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– 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.
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7. TARGET SPECIES
Cattle
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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 3 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.
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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.
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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 after the expiry date which is stated on the carton and label after EXP.
Once broached use immediately.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate only healthy animals.
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 cattle.
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) :
A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of two-fold overdose.
Incompatibilities :
Do not mix with any other veterinary medicinal product.
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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.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED