Syvazul BTV
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
20-01-2022
Vara einkenni
(SPC)
20-01-2022
Opinber matsskýrsla
(PAR)
01-01-1970
Virkt innihaldsefni:
Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004, Inactivated bluetongue virus, serotype 8, strain BEL2006/01
Fáanlegur frá:
LABORATORIOS SYVA, S.A.U.
ATC númer:
QI04AA02
INN (Alþjóðlegt nafn):
Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)
Meðferðarhópur:
Cattle; Sheep
Lækningarsvæði:
Inactivated viral vaccines
Ábendingar:
For active immunisation of sheep to prevent viraemia and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4For active immunisation of cattle to prevent viraemia caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4.
Vörulýsing:
Revision: 3
Leyfisstaða:
Authorised
Leyfisdagur:
2019-01-09
Upplýsingar fylgiseðill
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET :
SYVAZUL BTV SUSPENSION FOR INJECTION FOR SHEEP AND CATTLE
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
LABORATORIOS SYVA, S.A.U.
Av. Párroco Pablo Diez, 49-57
24010 LEÓN
SPAIN
Manufacturer responsible for batch release:
LABORATORIOS SYVA, S.A.U.
Parque Tecnológico de León
Av. Portugal s/n
Parcelas M15-M16
24009 LEÓN
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Syvazul BTV suspension for injection for sheep and cattle
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
ACTIVE SUBSTANCES*:
Inactivated bluetongue virus (BTV)
RP** ≥ 1
* Maximum of two different inactivated bluetongue virus serotypes:
Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1
Inactivated bluetongue virus, serotype 4 (BTV-4), strain
BTV-4/SPA-1/2004
Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
** Relative potency measured by ELISA in relation to a reference
vaccine whose efficacy has been
demonstrated by challenge in the target species.
The number and type(s) of strains included in the final product will
be adapted to the current
epidemiological situation at the time of formulation of the final
product and will be shown on the
label.
ADJUVANTS:
Aluminium hydroxide (Al
3+
)
2.08 mg
Semi-purified saponin from
_Quillaja saponaria_
0.2 mg
18
EXCIPIENT:
Thiomersal
0.1 mg
Pinkish-white suspension for injection easily homogenised by shaking.
4.
INDICATION(S)
Sheep:
For active immunisation of sheep to prevent viraemia* and reduce
clinical signs and lesions caused by
bluetongue virus serotypes 1 and/ or 8 and/or to reduce viraemia* and
clinical signs and lesions caused
by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
*Below the level of detection by the validated RT-PCR method at 1.32
log
10
TCID
50
/ml
Onset of immunity: 39 days after completion of the primary vaccination
s
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Syvazul BTV suspension for injection for sheep and cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES*:
Inactivated bluetongue virus (BTV)
RP** ≥ 1
* Maximum of two different inactivated bluetongue virus serotypes:
Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1
Inactivated bluetongue virus, serotype 4 (BTV-4), strain
BTV-4/SPA-1/2004
Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
** Relative potency measured by ELISA in relation to a reference
vaccine whose efficacy has been
demonstrated by challenge in the target species.
The number and type(s) of strains included in the final product will
be adapted to the current
epidemiological situation at the time of formulation of the final
product and will be shown on the
label.
ADJUVANTS:
Aluminium hydroxide (Al
3+
)
2.08 mg
Semi-purified saponin from
_Quillaja saponaria_
0.2 mg
EXCIPIENT:
Thiomersal
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Pinkish-white suspension easily homogenised by shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sheep:
For active immunisation of sheep to prevent viraemia* and reduce
clinical signs and lesions caused by
bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and
clinical signs and lesions caused
by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
*Below the level of detection by the validated RT-PCR method at 1.32
log
10
TCID
50
/ml
Onset of immunity: 39 days after completion of the primary vaccination
scheme.
3
Duration of immunity: one year after completion of the primary
vaccination scheme.
Cattle:
For active immunisation of cattle to prevent viraemia* caused by
bluetongue virus serotypes 1 and/or
8 and/or to reduce viraemia* caused by bluetongue virus serotype 4
(combination of maximum 2
seroty
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