BTVPUR AlSap 2-4

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

bluetongue-virus serotype-2 antigen, bluetongue-virus serotype-4 antigen

Available from:

Mérial

ATC code:

QI04AA02

INN (International Name):

inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections

Therapeutic group:

Sheep

Therapeutic area:

bluetongue virus, Inactivated viral vaccines, Immunologicals for ovidae

Therapeutic indications:

Active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.

Product summary:

Revision: 4

Authorization status:

Withdrawn

Authorization date:

2010-11-04

Patient Information leaflet

11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
BOX OF 1 BOTTLE OF 10 ML
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 2-4 suspension for injection for sheep
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 1ml of vaccine contains:
BTV2 antigen
................................................................................................................
6.8–9.5 CCID
50
*,
BTV4 antigen
................................................................................................................
7.1–8.5 CCID
50
*,
Aluminium hydroxide, Saponin, qs 1 dose *.
*see package leaflet.
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
10 doses (10 ml)
5.
TARGET SPECIES
Sheep
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Withdrawal period: zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
Medicinal product no longer authorised
12
10.
EXPIRY DATE
EXP {month/year}
Once broached, use immediately.
11.
SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2
°
C – 8
°
C).
Do not freeze.
Protect from light.
12.
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only. To be supplied only on veterinary
prescription.
14.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Keep out of the sight and reach of children.
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/10/108/005
17.
MANUFACTURER’S BATCH NUMBER
Lot {number}
Medicinal product no longer authorised
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
BOX OF 1 BOTTLE OF 50 ML, OR OF 10 BOTTLES OF 50 ML, OR OF 1 BOTTLE OF
100 ML, OR OF 10 BOTTLES OF
100 ML
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
B

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 2-4 suspension for injection for sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1ml of vaccine contains:
ACTIVE SUBSTANCES:
Bluetongue virus serotype 2 antigen
...............................................................................
6.8–9.5 CCID
50
*
Bluetongue virus serotype 4 antigen
...............................................................................
7.1–8.5 CCID
50
*
* Cell culture infectious dose 50% equivalent to titre prior to
inactivation (log
10
)
ADJUVANTS:
Aluminium hydroxide
2.7 mg,
Saponin
30 HU**
**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
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 by the validated RT-PCR method at 3.68
log
10
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.
4.3
CONTRAINDICATIONS
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.
Medicinal product no longer authorised
3
4.5
SPECIAL PRECAUTIONS FOR USE
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
Not applicable.