Zulvac 1 Ovis
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
01-04-2020
Fachinformation
(SPC)
01-04-2020
Öffentlichen Beurteilungsberichts
(PAR)
01-04-2020
Wirkstoff:
inactivated bluetongue virus, serotype-1
Verfügbar ab:
Zoetis Belgium SA
ATC-Code:
QI04AA02
INN (Internationale Bezeichnung):
inactivated bluetongue virus, serotype-1
Therapiegruppe:
Sheep
Therapiebereich:
Immunologicals
Anwendungsgebiete:
Active immunisation of sheep from 1.5 months of age for the prevention of viraemia caused by bluetongue virus, serotypes-1.Onset of immunity: 21 days after completion of the primary vaccination scheme.Duration of immunity: 12 months.
Produktbesonderheiten:
Revision: 6
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2011-08-05
Gebrauchsinformation
Medicinal product no longer authorised
16
B. PACKAGE LEAFLET
Medicinal product no longer authorised
17
PACKAGE LEAFLET:
ZULVAC 1 OVIS SUSPENSION FOR INJECTION FOR 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. Camprodón s/n "la Riba"
17813 Vall de Bianya
Girona
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 1 Ovis suspension for injection for sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each 2 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1
RP* ≥ 1
*Relative Potency by a mice potency test compared to a reference
vaccine that was shown efficacious in
sheep.
ADJUVANT:
Aluminium hydroxide (Al
3+
)
4 mg
Saponin
0.4 mg
EXCIPIENT:
Thiomersal
0.2 mg
Off-white or pink liquid.
4.
INDICATION(S)
For active immunisation of sheep from 1 and a half months of age for
the prevention* of viraemia caused
by Bluetongue Virus (BTV), serotypes 1.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR 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
Medicinal product no longer authorised
18
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient increase in rectal temperature, not exceeding 1.2 °C, may
occur very commonly during the 24
hours following vaccination.
Vaccination may be followed very commonly by a local reaction at the
injection site. These reactions take
the form in most cases of a general swelling of the injection site
(persisting for not more than 7 days) or of
palpable nodules (subcutaneous granuloma possibly persisting for more
than 48 days).
The frequency of adverse reacti
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Fachinformation
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
Zulvac 1 Ovis suspension for injection for sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCES:
Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1
RP* ≥ 1
*Relative Potency by a mice potency test compared to a reference
vaccine that was shown efficacious in
sheep.
ADJUVANTS:
Aluminium hydroxide (Al
3+
)
4 mg
Saponin
0.4 mg
EXCIPIENTS:
Thiomersal
0.2 mg
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
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of sheep from 1 and a half months of age for
the prevention* of viraemia caused
by Bluetongue Virus (BTV), serotype 1.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR 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
4.3
CONTRAINDICATIONS
None.
Medicinal product no longer authorised
3
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.
No information is available on the use of the vaccine in seropositive
animals including those with
maternally derived antibodies.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
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