Zulvac SBV
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
11-03-2020
Vara einkenni
(SPC)
11-03-2020
Opinber matsskýrsla
(PAR)
07-01-2015
Virkt innihaldsefni:
Inactivated Schmallenberg virus, strain BH80/11-4
Fáanlegur frá:
Zoetis Belgium SA
ATC númer:
QI02AA
INN (Alþjóðlegt nafn):
Inactivated Schmallenberg virus, strain BH80/11-4
Meðferðarhópur:
Cattle; Sheep
Lækningarsvæði:
Immunologicals for bovidae, Inactivated viral vaccines
Ábendingar:
For active immunisation of cattle and sheep from 3.5 months of age to prevent viraemia associated with infection by Schmallenberg virus.
Vörulýsing:
Revision: 3
Leyfisstaða:
Authorised
Leyfisdagur:
2015-02-06
Upplýsingar fylgiseðill
15
3B
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
ZULVAC SBV SUSPENSION FOR INJECTION FOR CATTLE AND SHEEP
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Zoetis Manufacturing & Research Spain, S.L.
Ctra. de Camprodón, s/n°
Finca La Riba
Vall de Bianya
Gerona, 17813
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac SBV suspension for injection for cattle and sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCE:
AMOUNT PER 2 ML DOSE
(CATTLE)
AMOUNT PER 1 ML DOSE
(SHEEP)
Inactivated Schmallenberg virus,
strain BH80/11-4
RP* ≥ 1
RP* ≥ 1
_ _
ADJUVANTS:
Aluminium hydroxide
Quil-A (
_Quillaja saponaria_
_ _
saponin
extract)
385.2 mg (4 mg Al
3+
)
0.4 mg
192.6 mg (2 mg Al
3+
)
0.2 mg
EXCIPIENT:
Thiomersal
0.2 mg
0.1 mg
*Relative potency (mice potency test) compared to a reference vaccine
that was shown efficacious in
the target animal species.
Off-white or pink liquid.
4.
INDICATION(S)
Cattle:
For active immunisation of cattle from 3.5 months of age to reduce
viraemia* associated with
infection by Schmallenberg virus.
Onset of immunity: 2 weeks after completion of the primary vaccination
course.
17
Duration of immunity: 1 year after completion of the primary
vaccination course.
Sheep:
For active immunisation of sheep from 3.5 months of age to reduce
viraemia* associated with
infection by Schmallenberg virus.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 months after vaccination.
Vaccination of breeding sheep before pregnancy according to the
recommended schedule described in
section 8 results in reduction of viraemia* and transplacental
infection associated with infection by
Schmallenberg virus during the first trimester of pregnancy.
*Below the level of detection by the validated RT-PCR method at 3.6
log
10
RNA copi
Lestu allt skjalið
Vara einkenni
1
ANNEX I
0B
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac SBV suspension for injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
AMOUNT PER 2 ML DOSE
(CATTLE)
AMOUNT PER 1 ML DOSE
(SHEEP)
Inactivated Schmallenberg virus,
strain BH80/11-4
RP* ≥ 1
RP* ≥ 1
_ _
ADJUVANTS:
Aluminium hydroxide
Quil-A (
_Quillaja saponaria_
saponin
extract)
_ _
385.2 mg (4 mg Al
3+
)
0.4 mg
192.6 mg (2 mg Al
3+
)
0.2 mg
EXCIPIENT:
Thiomersal
0.2 mg
0.1 mg
*Relative potency (mice potency test) compared to a reference vaccine
that was shown efficacious in
the target animal species.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Off-white or pink liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
For active immunisation of cattle from 3.5 months of age to reduce
viraemia* associated with
infection by Schmallenberg virus.
Onset of immunity: 2 weeks after completion of the primary vaccination
course.
Duration of immunity: 1 year after completion of the primary
vaccination course.
Sheep:
For active immunisation of sheep from 3.5 months of age to reduce
viraemia* associated with
infection by Schmallenberg virus.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 months after vaccination.
Vaccination of breeding sheep before pregnancy according to the
recommended schedule described in
section 4.9 results in reduction of viraemia* and transplacental
infection associated with infection by
Schmallenberg virus during the first trimester of pregnancy.
3
*Below the level of detection by the validated RT-PCR method at 3.6
log
10
RNA copies/ml of plasma
for cattle and at 3.4 log
10
RNA copies/ml of plasma for sheep.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
No information is available on the use of the vaccine in seropositive
animals including those with
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