Summary of Product Characteristics (SmPC) - Zulvac 1 Bovis
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 1 Bovis suspension for injection for cattle
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
Active substance:
RP* > 1
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 calves.
Adjuvants:
Aluminium hydroxide (Al3+) Saponin
0.4 mg
Excipient:
Thiomersal
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection. Off-white or pink liquid
4. CLINICAL PARTICULARS
4.1 Target species
.2 mg
Cattle.
4.2 Indications for use, specifying the target species
For active immunisation of cattle from 2 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotype 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 course.
Duration of immunity: 12 months after completion of the primary vaccination course.
4.3 Contraindications
4.4 Special warnings for each target species
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. No information is available on the use of the vaccine in animals with maternally derived antibodies
4.5 Special precautions for use
Special precautions for use in animals Vaccinate only healthy animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None
4.6 Adverse reactions (frequency and seriousness)
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, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy. No data is available on safety in lactating animals. The use in lactating animals is therefore not recommended.
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).
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.
4.9 Amounts to be administered and administration route
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
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.
In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi- injection type vaccination system when larger dose presentations are used.
Revaccination:
Any revaccination 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
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.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus. ATCvet code: QI02AA08
To stimulate active immunity against Bluetongue Virus, serotype 1 in cattle.
6. PHARMACEUTICAL PARTICULARS
6.1 List of exci
Aluminium hydroxide Saponin Thiomersa Potassium
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 after broaching.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C).
Protect from light.
Do not freeze.
6.5 Nature and composition of immediate packaging
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.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Zoetis Belgium SA
Rue Laid Burniat 1 1348 Louvain-la-Neuve
BELGIUM
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/11/130/001
EU/2/11/130/002
EU/2/11/130/003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 05/08/2011
Date of last renewal: 18/04/2016
10. DATE OF REVISION OF THE TEXT
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.