Syvazul BTV

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

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

Διαθέσιμο από:

LABORATORIOS SYVA, S.A.U.

Φαρμακολογική κατηγορία (ATC):

QI04AA02

INN (Διεθνής Όνομα):

Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)

Θεραπευτική ομάδα:

Cattle; Sheep

Θεραπευτική περιοχή:

Inactivated viral vaccines

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Revision: 3

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2019-01-09

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

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