Zulvac BTV
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
01-09-2021
Summary of Product characteristics
(SPC)
01-09-2021
Public Assessment Report
(PAR)
01-09-2021
Active ingredient:
One of the following inactivated bluetongue virus strains:Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
Available from:
Zoetis Belgium SA
ATC code:
QI02AA
INN (International Name):
Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)
Therapeutic group:
Sheep; Cattle
Therapeutic area:
Immunologicals, Immunologicals for bovidae, Inactivated viral vaccines, bluetongue virus, SHEEP
Therapeutic indications:
Active immunisation of sheep from 6 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8, and for the reduction of viraemia caused by bluetongue virus, serotype 4 and active immunisation of cattle from 12 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8.
Product summary:
Revision: 2
Authorization status:
Authorised
Authorization date:
2017-04-25
Patient Information leaflet
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET:
ZULVAC 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:
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 BTV suspension for injection for sheep and cattle
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCES:
One of the following inactivated bluetongue
virus strains
AMOUNT PER 2 ML DOSE
(BTV-1, BTV-4, BTV-8
in sheep;
BTV-1, BTV-8 in cattle)
AMOUNT PER 4 ML
DOSE
(BTV-4 in cattle)
Inactivated bluetongue virus, serotype 1,
strain BTV-1/ALG2006/01 E1
RP* ≥ 1
n.a.
Inactivated bluetongue virus, serotype 8,
strain BTV-8/BEL2006/02
RP* ≥ 1
n.a.
Inactivated bluetongue virus, serotype 4,
strain SPA-1/2004
RP* ≥ 0.8
RP* ≥ 0.8
ADJUVANTS:
Al
3+
(as hydroxide)
4 mg
8 mg
Quil-A (
_Quillaja saponaria_
saponin extract)
0.4 mg
0.8 mg
EXCIPIENTS:
Thiomersal
0.2 mg
0.4 mg
n.a.: not applicable
*Relative potency by a mice potency test compared to a reference
vaccine efficacious in sheep and/or
cattle.
29
The type of strain 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. The target species will
also be shown on the label.
Off-white or pink liquid.
4.
INDICATION(S)
Sheep:
Active immunisation of sheep from 6 weeks of age for the prevention*
of viraemia caused by
bluetongue virus, serotype 1 or serotype 8.
Active immunisation of sheep from 6 weeks of age for the reduction* of
viraemia caused by
bluetongue virus, serotype 4.
*Below the level of detection of <3.9 log
10
genome copies/ml by the validated RT-qPCR method,
indicating no presenc
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac BTV suspension for injection for sheep and cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
One of the following inactivated bluetongue
virus strains
AMOUNT PER 2 ML DOSE
(BTV-1, BTV-4, BTV-8
in sheep;
BTV-1, BTV-8 in cattle)
AMOUNT PER 4 ML
DOSE
(BTV-4 in cattle)
Inactivated bluetongue virus, serotype 1,
strain BTV-1/ALG2006/01 E1
RP* ≥ 1
n.a.
Inactivated bluetongue virus, serotype 8,
strain BTV-8/BEL2006/02
RP* ≥ 1
n.a.
Inactivated bluetongue virus, serotype 4,
strain SPA-1/2004
RP* ≥ 0.8
RP* ≥ 0.8
ADJUVANTS:
Al
3+
(as hydroxide)
4 mg
8 mg
Quil-A (
_Quillaja saponaria_
saponin extract)
0.4 mg
0.8 mg
EXCIPIENTS:
Thiomersal
0.2 mg
0.4 mg
For the full list of excipients, see section 6.1.
n.a.: not applicable
*Relative potency by a mice potency test compared to a reference
vaccine efficacious in sheep and/or
cattle.
The type of strain 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. The target species will
also be shown on the label.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Off-white or pink liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sheep:
Active immunisation of sheep from 6 weeks of age for the prevention*
of viraemia caused by
bluetongue virus, serotype 1 or serotype 8.
3
Active immunisation of sheep from 6 weeks of age for the reduction* of
viraemia caused by
bluetongue virus, serotype 4.
*Below the level of detection of <
3.9 log
10
genome copies/ml by the validated RT-qPCR method,
indicating no presence of viral genome.
Onset of immunity: 21 days after completion of the primary vaccination
scheme.
Duration of immunity: 12 months after completion of the primary
vaccination scheme.
Cattle:
Active immunisation of cattle from 12 weeks of age for the
prevention** of viraemia caused by
bl
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