Zulvac 1 Bovis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
30-03-2020
Charakterystyka produktu
(SPC)
30-03-2020
Sprawozdanie z oceny publicznego
(PAR)
30-03-2020
Składnik aktywny:
inactivated bluetongue virus, serotype 1
Dostępny od:
Zoetis Belgium SA
Kod ATC:
QI02AA08
INN (International Nazwa):
inactivated bluetongue virus, serotype 1
Grupa terapeutyczna:
Cattle
Dziedzina terapeutyczna:
Immunologicals
Wskazania:
Active immunisation of cattle from 2½ months of age for the prevention of viraemia caused by bluetongue virus, serotype 1.Onset of immunity: 15 days after completion of the primary vaccination course.Duration of immunity: 12 months.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2011-08-05
Ulotka dla pacjenta
Medicinal product no longer authorised
15
B. PACKAGE LEAFLET
Medicinal product no longer authorised
16
PACKAGE LEAFLET:
ZULVAC1 BOVIS SUSPENSION FOR INJECTION FOR 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. Camprodón s/n "la Riba"
17813 Vall de Bianya
Girona
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 1 Bovis suspension for injection for cattle
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
cattle.
ADJUVANTS:
Aluminium hydroxide (Al
3+
)
4 mg
Saponin
0.4 mg
EXCIPIENT:
Thiomersal
0.2 mg
Off-white or pink liquid.
4.
INDICATIONS(S)
For active immunisation of cattle from 2 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: 15 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
17
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
After first vaccination a rectal temperature increase of up to 1.6°C
may occur very commonly the 3
rd
day
after the injection. Rectal temperatures should then return to normal
values.
After second and third vaccination a rectal temperature increase of up
to 1.3°C and 2.8°C respectively may
occur very commonly one day after the injection and then rectal
temperatures return to normal values.
The frequency of adverse reactions is defined using the follow
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Charakterystyka produktu
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 Bovis suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
calves.
ADJUVANTS:
Aluminium hydroxide (Al
3+
)
4 mg
Saponin
0.4 mg
EXCIPIENT:
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
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle from 2 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: 15 days after completion of the primary vaccination
course.
Duration of immunity: 12 months after completion of the primary
vaccination course.
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 cattle.
No information is available on the use of the vaccine in animals 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)
After first vaccinati
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