BTVPUR Alsap 8
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
17-05-2018
Charakterystyka produktu
(SPC)
17-05-2018
Sprawozdanie z oceny publicznego
(PAR)
16-05-2018
Składnik aktywny:
bluetongue virus serotype 8 antigen
Dostępny od:
Merial
Kod ATC:
QI02AA08
INN (International Nazwa):
adjuvanted bluetongue virus vaccine
Grupa terapeutyczna:
Sheep; Cattle
Dziedzina terapeutyczna:
Immunologicals for ovidae, Immunologicals for bovidae
Wskazania:
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.*(below the level of detection by the validated RT-PCR method at 3.14log10 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.The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Withdrawn
Data autoryzacji:
2009-03-17
Ulotka dla pacjenta
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 8 suspension for injection
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 1 ml of vaccine contains: BTV8
antigen...............................................
≥
2.1 log10 pixels*
Aluminium hydroxide, Saponin, qs 1 dose (*)
(*) see package leaflet
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
1 bottle of 10 doses (1 x 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.
8.
WITHDRAWAL PERIOD
Withdrawal period: zero days.
Medicinal product no longer authorised
11
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10.
EXPIRY DATE
EXP {month/year}
Shelf life after first opening the immediate packaging: immediately
after broaching.
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/2/09/094/001
EU/2/09/094/002
EU/2/09/094/003
EU/2/09/094/004
EU/2/09/094/005
Medicinal product no longer authorised
12
17.
MANUFACTURER’S BATCH NU
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Charakterystyka produktu
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 8, suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml of vaccine contains:
ACTIVE SUBSTANCES:
Bluetongue virus serotype 8 antigen
...........................................................................
≥
2.1 log10 pixels*
(*) Antigen content (VP2 protein) by immuno-assay
ADJUVANTS:
Aluminium hydroxide
....................................................................................................................
2.7 mg
Saponin
........................................................................................................................................
30 HU**
(**) Haemolytic units
EXCIPIENTS:
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, SPECIFYING THE TARGET SPECIES
Active immunisation of sheep and cattle to prevent viraemia* and to
reduce clinical signs caused by
bluetongue virus serotype 8.
* (below the level of detection by the validated RT-PCR method at 3.14
log10 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
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