Summary of medicine characteristics - BTVPUR Alsap 8
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml of vaccine contains:
Bluetongue virus serotype 8 antigen..........................
-
(*) Antigen content (VP2 protein) by immuno-assay
Aluminium hydroxide................................................
Saponin.......................................................................
-
(** ) Haemolytic units
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
4. CLINICAL PARTICULARS
4.1 Target species
Sheep and cattle
4.2 Indications for use, specifyi
Active immunisation of sheep a bluetongue virus serotype 8.
* (below the level of detection by indicating no infectious virus tran
e to prevent viraemia* and to reduce clinical signs caused by
the validated RT-PCR method at 3.14 log10 RNA copies/ml, smission)
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.
4.3 Contra
None.
4.4 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 and cattle.
4.5 Special precautions for use
Vaccinate healthy animals only.
or a short
None
4.6 Adverse reactions (frequency and seriousness)
Vaccination may be followed by a small local swelling at the injection site (at mos period (at most 14 days).
, may occur
A transient increase in body temperature, normally not exceeding an avera within 24 hours after vaccination.
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy in ewes. Can be used during pregnancy and lactation in cows.
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 th rent vaccination policies against Bluetongue Virus (BTV).
4.8 Interaction with other medicinal products 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.
4.9 Amounts to be administered and administration route
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine.
4.11 Withdrawal period
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code: QI04AA02 (sheep QI02AA08 (cattle).
The vaccine contains inactivated bluetongue virus serotype 8 with aluminium hydroxi adjuvants. It induces an active and specific immunity against bluetongue virus serotyp vaccinated animal.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Aluminium hydroxide
Purified saponin Silicon antifoam Phosphate buffer Glycine buffer Water for injection
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
6.4 Special precautions for storage°C-8 °C).
6.5 Nature and composition of immediate packaging
Polypropylene bottle of 50 or 100 ml with butyl elastomere closure. Box of 1 bottle of 100 doses (1 × 100 ml).
Box of 10 bottles of 100 doses (10 × 100 ml).
Box of 1 bottle of 50 doses (1 × 50 ml).
Box of 10 bottles of 50 doses (10 × 50 ml).
Type I glass bottle of 10 ml with butyl elastomere 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
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal 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)
EU/2/09/094/001
EU/2/09/094/002
EU/2/09/094/003
EU/2/09/094/004
EU/2/09/094/005
F THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEW
17/03/200910. DATE OF REVISION OF THE TEX
Detailed information on this pro.
lable on the website of the European Medicines Agency