Patient leaflet - Bovilis BTV8
B. PACKAGE LEAFLET
PACKAGE LEAFLET FOR:
Bovilis BTV8 suspension for injection for cattle and sheep
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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
Intervet International BV
Wim de Korverstraat 35
5831 AN Boxmeer
The NETHERLANDS
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis BTV8 suspension for injection for cattle and sheep
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose (1 ml) contains:
Active ingredient: bluetongue virus serotype 8: 500 antigenic units* (* inducing a virus neutralising antibody response in chickens of > 5.0 log2)
Adjuvants: aluminium hydroxide, saponin.
Opalescent pink with resuspendable sediment.
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4. INDICATION(S)
Sheep
To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia*.
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(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.
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* (for details see section 12)
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 months.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
In very rare cases 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, while in cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of vaccinates. After administration of a double dose in cattle and sheep no other reactions were observed. 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.
In very rare cases hypersensitivity reactions may occur.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
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– common (more than 1 but less than 10 animals in 100 animals)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals )
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– rare (more than 1 but less than 10 animals in 10,000 animals)
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– very rare (less than 1 animal in 10,000 animals, including isolated reports)
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
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7. TARGET SPECIES
Cattle and sheep.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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.
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9. ADVICE ON CORRECT ADMINISTRATION
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.
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10. WITHDRAWAL PERIOD
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 this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.Once broached use within 8 hours, provided the product is not subject to temperatures above 37 °C or contaminated.
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12. SPECIAL WARNING(S)
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 or 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 in animals:
Vaccinate healthy animals only.
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.
Pregnancy and lactation:
The vaccine can be used during pregnancy and lactation.
Fertility:
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 bluetongue virus.
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.
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
Detailed information on this product is available on the website of the European Medicines Agency
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15. OTHER INFORMATION