BTVPUR AlSap 2-4
inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections
18
authorised
no
Medicinal
Medicinal product no longer 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 2-4 suspension for injection for sheep
Each dose of 1 ml of vaccine contains:
Bluetongue virus serotype 2 antigen ..............................................................................6.8–9.5 CCID50*,
Bluetongue virus serotype 4 antigen ..............................................................................7.1–8.5 CCID50*,
Aluminium hydroxide 2.7 mg,
Saponin 30 HU**.
*Cell culture infectious dose 50% equivalent to titre prior to inactivation (log10).
**Haemolytic units.
Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.
*below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission.
Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively.
The duration of immunity is 1 year after primary vaccination course.
None.
Medicinal product no longer authorised
Vaccination may be followed by a small local swelling at the injection site (at most 24 cm²) for a short period (at most 14 days).
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 package leaflet, please inform your veterinary surgeon.
Sheep
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
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.
Zero days.
Keep out of the sight and reach of children. Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Shelf life after first opening the immediate packaging: use immediately.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label after EXP.
Medicinal product no longer authorised
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 sheep.
Special precautions for use in animals: Vaccinate healthy animals only.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Fertility:
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).
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.
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.
Detailed information on this product is available on the website of the European Medicines Agency (/).
The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with aluminium hydroxide and saponin adjuvants. It induces an active and specific immunity against bluetongue virus serotypes
2 and 4 in the vaccinated animals. Not all pack sizes may be marketed.
Medicinal product no longer authorised
Pack sizes:
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)
Box of 1 bottle of 100 doses (1 x 100 ml)
Box of 10 bottles of 100 doses (10 x 100 ml)
The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 2-4 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. Any person intending to manufacture, import, possess, sell, supply and use BTVPUR AlSap 2-4 must consult the relevant Member State’s competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.