Revised: February 2014
AN: 01124/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis SBV, suspension for injection of cattle and sheep.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml of vaccine:
Active substance:
Inactivated Schmallenberg virus (SBV): > 4.0 log2 VN titre1
1Virus Neutralizing (VN) titre in at least 5 out of 7 animals in sheep batch potency test
Adjuvants:
Aluminium hydroxide 16.8 mg
Saponin 0.32 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Opalescent white to pink suspension for injection.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle and sheep.
4.2 Indications for use, specifying the target species
Cattle:
For the active immunisation of cattle to reduce viraemia caused by Schmallenberg virus.
Sheep:
For the active immunisation of sheep to reduce viraemia caused by Schmallenberg virus.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: unknown.
This is a Provisional Marketing Authorisation. A full set of supporting efficacy data is not available for this product.
4.3 Contraindications
None.
4.4 Special warnings
This vaccine has been evaluated for safety and efficacy in sheep and cattle. 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 seropositive animals, including those with maternally derived antibodies.
4.5 Special precautions for use
i) Special precautions for use in animals
Vaccinate only healthy animals.
ii) 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.
4.6 Adverse reactions (frequency and seriousness)
Immunisation may result in a slight rise in temperature (up to about 1oC) for up to three days after vaccination, and temporary swellings at the injection site. In sheep, swellings may be observed in most of the vaccinated animals. In sheep swellings have been observed up to 9 cm2 (average 7.5 cm2), which may last for more than two weeks. No local reactions have been observed in cattle. As with any other vaccine, occasional hypersensitivity reactions may occur.
4.7 Use during pregnancy, lactation or lay
Do not use in pregnant animals.
The safety and efficacy of the vaccine has not been established in breeding males. In these categories of animals the vaccine should be used only according to the risk/benefit assessment by the responsible veterinarian and/or the national Competent Authorities, depending on the current vaccination policies against SBV.
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
Before using the vaccine allow it to reach ambient temperature (15 - 25°C).
Shake the bottle before use and periodically during use.
Use clean and sterile vaccination equipment and avoid the introduction of contamination.
It is recommended to use a multiject vaccination system.
Cattle
Primary vaccination
Cattle from 2 months of age: intramuscular injection of two doses of 2 ml, administered with an interval of approximately 4 weeks.
Revaccination:
As the duration of immunity is not yet established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Sheep
Primary vaccination:
Sheep from 4 months of age: subcutaneous injection of one dose of 2 ml
Revaccination:
As the duration of immunity is not yet established, 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
Not applicable.
4.11 Withdrawal period
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Inactivated viral vaccine, to stimulate active immunity against SBV.
ATCvet code: Cattle: QI02AA
Sheep: QI04AA
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Trometamol
Sodium chloride
Maleic acid
Simethicone emulsion
Aluminium hydroxide
Saponin
Water for injection
6.2 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: provisionally 1 year.
Shelf life after first opening the immediate packaging: use immediately after broaching (maximum within 4 hours).
6.4 Special precautions for storage
Store and transport refrigerated (2 – 8°C).
Protect from direct light.
Do not freeze.
6.5 Nature and composition of immediate packaging
PET vials of 20 or 100 ml, with a halogenobutyl rubber stopper and aluminium cap.
Pack size: box with 1 or 10 vials.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from 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
Intervet UK Ltd
Walton Manor
Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm: 01708/4603
9. DATE OF FIRST AUTHORISATION
Date: 21 May 2013
10. DATE OF REVISION OF THE TEXT
Date: February 2014
12 February 2014
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