Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk
Bovilis BTV8 suspension for injection for cattle and sheep
Company name: MSD Animal Health
Address: Walton Manor
Walton
Milton Keynes
MK7 7AJ
Telephone: 01908 685685 (Customer Support Centre)
Fax: 01908 685555
Email: vet-support.uk@merck.com
Website: www.msd-animal-health.co.uk
Qualitative and quantitative composition
Active substance 1 ml dose contains: Bluetongue Virus Serotype 8 (prior to inactivation): 500 Antigenic
Units *.
(* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2).
Adjuvants
Aluminium hydroxide (as 100%) 16.7 mg and Saponin 0.31 mg.
Target species
Cattle and sheep
Indications for use
Sheep
To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia*.
*(cycling value (Ct) >30 by a validated rRT-PCR method, indicating absence of infectious virus).
Cattle
To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia*.
* (for details see section Special warnings for each target species).
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 months.
Contra-indications
None.
Special warnings for each target species
This vaccine has been shown to reduce but not prevent viraemia in cattle. The extent of this reduction has been shown by epidemiological modelling studies to be likely to reduce virus transmission to an extent that can limit the spread of an outbreak in a vaccinated population. This vaccine has been tested for safety 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.
Special precautions for use
Vaccinate healthy animals only.
Operator warnings:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Vaccination may result in a slight rise in temperature (usually not more than 0.5°C, in individual cases up to about 2°C) for up to three days after vaccination, and temporary swellings at the injection site. In sheep these swellings typically last for up to three weeks. In cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of the vaccinated animals. Occasional hypersensitivity reactions may occur.
Use during pregnancy, lactation or lay
The vaccine can be used during pregnancy and lactation.
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 benefit/risk assessment by the responsible veterinarian and/or the national Competent Authorities, depending on the current vaccination policies against BTV.
Interactions
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.
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.
Sheep
Primary vaccination:
Sheep from 1 month of age: subcutaneous injection of a single dose of 1 ml.
Revaccination:
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Cattle
Primary vaccination
Cattle from 6 weeks of age: subcutaneous injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.
Revaccination:
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Overdose
No adverse reactions other than those described in section "Adverse Reactions" were observed following administration of a double dose in cattle and sheep. However, the temperature rise may be 0.5°C higher and the swellings may be more pronounced and palpable for a longer period. In sheep, swellings may still be palpable after six weeks.
Withdrawal periods
Zero days.
Immunological properties
ATCvet code Sheep: QI04AA02 & Cattle: QI02AA08
Inactivated viral vaccine, to stimulate active immunity against Bluetongue Virus Serotype 8.
Excipients
Trometamol, Sodium chloride, Maleic acid, Simeticone emulsion, Aluminium hydroxide, Saponin and Water for injection.
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
10, 20 and 50 ml vials: 2 years.
100, 200, 250 and 500 vials: 12 months.
Shelf-life after first opening the immediate packaging: 8 hours, provided the product is not subject to temperatures above 37°C or contaminated.
Special precautions for storage
Store and transport refrigerated (2°C to 8°C). Protect from light. Do not freeze.
Immediate packaging
PET vials of 10, 20, 50, 100, 200, 250 or 500 ml, with a rubber stopper and aluminium cap.
Pack size: cardboard box with 1 or 10 vials.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Marketing Authorisation Holder (if different from distributor)
Intervet International BV, Wim de Körverstraat 35 , 5831 AN Boxmeer, The Netherlands.
The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Any person intending to import, sell, supply and/or use Bovilis BTV8 must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
For animal treatment only. Keep out of reach and sight of children.