Summary of medicine characteristics - Zulvac 8 Ovis
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 8 Ovis suspension for injection for sheep
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 2 ml of vaccine contains:
Active substance:
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.
Adjuvant(s):
Aluminium hydroxide (Al3+) 4 mg
Quil-A (Quillaja saponaria saponin extract) 0.4 mg
Excipient:
Thiomersal 0.2 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Off-white or pink suspension for injection.
4. CLINICAL PARTICULARS4.1 Target species
Sheep.
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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, serotype 8.
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*(Cycling value (Ct) > 36 by a validated RT-PCR method, indicating no presence of viral genome).
Onset of immunity: 25 days after administration of the second dose.
Duration of immunity: at least 1 year after the primary vaccination course.
4.3 Contraindications
None.
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4.4 Special warnings for each target species
Vaccinate healthy animals only.
Use in other domestic and wild ruminant species that are considered at risk of infection 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.
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4.5 Special precautions for use
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.
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4.6 Adverse reactions (frequency and seriousness)
A transient increase in rectal temperature during the 24 hours following vaccination not exceeding 1.2°C and local reaction at the injection site, in most cases in the form of a general swelling (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days) were observed very commonly in one laboratory safety study. These clinical signs have been reported very rarely from the field.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– 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).
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4.7 Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy.
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 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.
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4.9 Amounts to be administered and administration route
Subcutaneous use.
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. 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.
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.
Re-vaccination:
Any re-vaccination 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).
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Ovidae, inactivated viral vaccines for sheep, bluetongue virus.
ATC vet code: QI04AA02.
To stimulate active immunity against bluetongue virus, serotype 8 in sheep.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Aluminium hydroxide
Quil-A (Quillaja saponaria saponin extract)
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.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light.
Do not freeze.
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6.5 Nature and composition of immediate packaging
Type II hydrolytic glass bottles containing 100 or 240 ml. The glass bottle is closed with butyl stopper and held in place with an aluminium cap.
Pack sizes
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.
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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/2/09/104/001
EU/2/09/104/002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 15/01/2010.
Date of last renewal: 07/11/2014.