Summary of medicine characteristics - BTVPUR AlSap 2-4
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
1. NAME OF THE VETERINARY MEDICINAL PRODUCTBTVPUR AlSap 2–4 suspension for injection for sheep
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONEach dose of 1ml of vaccine contains:
Bluetongue virus serotype 2 antigen............................................................
Bluetongue virus serotype 4 antigen...........................................................
* Cell culture infectious dose 50% equivalent to titre prior to inactivation
Aluminium hydroxide
Saponin
**Haemolytic units
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
4. CLINICAL PARTICULARS
4.1 Target species
Sheep
2.7 mg, 30 HU**
6.8–9.5 CCID50*
.7.1–8.5 CCID50*
4.2 Indications for use, specifying the target species
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 indicating no infectious viru
validated RT-PCR method at 3.68 log10 RNA copies/ml, ission)
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 im
None.
4.4
4.3 Co
ns
is 1 year after primary vaccination course.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in ese species should be undertaken with care and it is advisable to test the vaccine on a small number imals prior to mass vaccination. The level of efficacy for other species may differ from that ed in sheep.
4.5 Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
24 cm2) for a
Special precautions to be taken by the person administering the veterinary medicinal pro animals
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
4.6 Adverse reactions (frequency and seriousness)Vaccination may be followed by a small local swelling at the injection site (at short period (at most 14 days).
.1 °C, may occur
A transient increase in body temperature, normally not exceeding an average o within 24 hours after vaccination.
-
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
The safety and the efficacy of the vaccine have not been establis reeding 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).
4.8 Interaction with other medicinal productsther forms of interaction
4.8 Interaction with other medicinal productsther forms of interactionNo 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.
4.9 Amounts to be administered and
Subcutaneous use.
Apply usual aseptic procedures Shake gently immediately befor injection. The entire content same procedure. Avoid multi
Administer one dose of 1 m
use. Avoid bubble formation, as this can be irritating at the site of e bottle should be used immediately after broaching and during the ial broaching.
cutaneously according to the following vaccination scheme:
Annual.
Primary vaccination
nth of age in naive animals (or from 2.5 months of age in young animals born
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 4.11 Withdrawal periodZero days.5. IMMUNOLOGICAL PROPERTIESPharmacotherapeutic group: inactivated bluetongue virus vaccine for sheep. ATCvet code QI04AA02.The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with alumini saponin adjuvants. It induces an active and specific immunity against bluetongue vi and 4 in the vaccinated animals.ydroxide and erotypes 26. PHARMACEUTICAL PARTICULARS6.1 List of excipientsSilicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.6.2 IncompatibilitiesDo not mix with any other veterinary medicinal pr6.3 Shelf lifeShelf life of the veterinary medicinal pro Shelf life after first opening the immedia
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 4.11 Withdrawal periodZero days.5. IMMUNOLOGICAL PROPERTIESPharmacotherapeutic group: inactivated bluetongue virus vaccine for sheep. ATCvet code QI04AA02.The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with alumini saponin adjuvants. It induces an active and specific immunity against bluetongue vi and 4 in the vaccinated animals.ydroxide and erotypes 26. PHARMACEUTICAL PARTICULARS6.1 List of excipientsSilicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.6.2 IncompatibilitiesDo not mix with any other veterinary medicinal pr6.3 Shelf lifeShelf life of the veterinary medicinal pro Shelf life after first opening the immediaStore and transport refrigerated Do not freeze.
Protect from light.
6.4 Special precautions for st
ackage for sale: 18 months. ging: use immediately.
6.5 Nature and composition of immediate packaging
Polypropylene bottle of 50 or 100 ml with butyl elastomer closure.
Box of 10 bottl
Box of 1 bottl
Box of 10
es (1 × 100 ml).
0 doses (10 × 100 ml). doses (1 × 50 ml).
f 50 doses (10 × 50 ml).
Box of 1 bottle o
Type I glass bottle of 10 ml with butyl elastomer closure. Box of 1 bottle of 10 doses (1 × 10 ml).
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such productsF THE AUTHORISATION
Any unused veterinary medicinal product or waste materials derived from such veterinary me products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/REN
10. DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency ).