BTVPUR AlSap 1

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

bluetongue-virus serotype-1 antigen

MAH:

Merial

ATC_code:

QI04AA02

INN:

bluetongue-virus serotype-1 antigen

therapeutic_group:

Sheep; Cattle

therapeutic_area:

Immunologicals

therapeutic_indication:

Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotype 1.Onset of immunity has been demonstrated three weeks after the primary vaccination course. The duration of immunity for cattle and sheep is one year after the primary vaccination course.

leaflet_short:

Revision: 4

authorization_status:

Withdrawn

authorization_date:

2010-12-17

PIL

Medicinal product no longer authorised
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
BOX OF 1 BOTTLE OF 10 ML,
BOX OF 1 BOTTLE OF 50 ML,
BOX OF 10 BOTTLES OF 50 ML,
BOX OF 1 BOTTLE OF 100 ML,
BOX OF 10 BOTTLES OF 100 ML
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 1 suspension for injection for sheep and cattle
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 1 ml contains:
Inactivated BTV1
.....................................................................................................
≥
1.9 log
10
pixels*
Aluminium hydroxide, Saponin, qs 1 dose (*)
(
*
)
see package leaflet
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
1 bottle of 10 doses (1x 10 ml)
1 bottle of 50 doses (1 x 50 ml)
10 bottles of 50 doses (10 x 50 ml)
1 bottle of 100 doses (1 x 100 ml)
10 bottles of 100 doses (10 x 100 ml)
5.
TARGET SPECIES
Sheep and cattle
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use
Read the package leaflet before use.
Medicinal product no longer authorised
11
8.
WITHDRAWAL PERIOD
Withdrawal period: zero days
9.
SPECIAL WARNING(S), IF NECESSARY
10.
EXPIRY DATE
EXP {month/year}
Once broached, use immediately.
11.
SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Do not freeze.
Protect from light.
12.
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
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/2/10/112/005
EU/2/10/112/003
EU/2/10/112/004
EU/2/10/112/001
EU/2/10/112/002
Medicinal product no longer authorised
12
17.
MANUFACTURER’S BATCH NUMBER
Lot {number}
Medicinal product no longer authorised
13
MINIMUM PARTICUL

SPC

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 1 suspension for injection for sheep and cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Inactivated Bluetongue Virus Serotype 1
.................................................................
≥
1.9 log
10
pixels*
(
*
)
Antigen content (VP2 protein) by immuno-assay
ADJUVANTS:
. Al
3+
(as hydroxide)
2.7 mg
. Saponin
30 HU**
(
**
)
Haemolytic units
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Homogeneous milky white suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of sheep and cattle to prevent viraemia* and to
reduce clinical signs caused by
bluetongue virus serotype 1.
*(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 weeks after the primary
vaccination course.
The duration of immunity for cattle and sheep is 1 year after the
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 and cattle.
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
None
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In very rare cases it has been observed a small local swelling at