BTVPUR Alsap 8
adjuvanted bluetongue virus vaccine
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Medicinal product no longer authorised
authorised
Marketing authorisation holder: MERIAL
29 avenue Tony Garnier 69007 Lyon,
France
Manufacturer responsible for batch release: MERIAL
Laboratory of Lyon Porte des Alpes Rue de l’Aviation,
69800 Saint-Priest
France
BTVPUR AlSap 8 suspension for injection
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Each dose of 1 ml of vaccine contains:
Bluetongue virus serotype 8 antigen ...........................................................................≥ 2.1 log10 pixels* Aluminium hydroxide .................................................................................................................... 2.7 mg
Saponin........................................................................................................................................30 HU**
(*) antigen content (VP2 protein) by immuno-assay (**) Haemolytic units
Medicinal
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue virus serotype 8 (BTV 8).
*below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission
Onset of immunity has been demonstrated 3 weeks after the primary vaccination course. The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
None.
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days).
authorised
A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Sheep and cattle.
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
In cattle and sheep
1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young cattle and sheep born to immune animals).
2nd injection: after 3–4 weeks.
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Annual.
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.
Medicinal
Zero days.
Keep out of the reach and sight of children. Store and transport refrigerated (2 °C-8 °C).
Do not freeze.
Protect from light.
Shelf life after first opening the immediate packaging: immediately after broaching.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Special precautions for use in animals: Vaccinate healthy animals only.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these
authorised
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.
Pregnancy and lactation:
Can be used during pregnancy in ewes. Can be used during pregnancy and lactation in cows.
Fertility:
The safety and the efficacy of the vaccine has 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).
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 decided on a case by case basis.
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions except those mentioned in section ‘Adverse Reactions’ were observed after the administration of a double-dose of vaccine.
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Incompatibilities:
Do not mix with any other veterinary medicinal product.
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 to protect the environment.
Medicinal
Detailed information on this product is available on the website of the European Medicines Agency
The vaccine contains inactivated Bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants. It induces an active and specific immunity against Bluetongue virus serotype 8 in the vaccinated animal.
Not all pack sizes may be marketed. Box of 1 bottle of 10 doses (1 x 10 ml).
Box of 1 bottle of 50 doses (1 x 50 ml).
Box of 10 bottles of 50 doses (10 x 50 ml).
authorised
Box of 1 bottle of 100 doses (1 x 100 ml).
Medicinal
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Box of 10 bottles of 100 doses (10 x 100 ml).