Zulvac 1+8 Ovis

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02

MAH:

Zoetis Belgium SA

ATC_code:

QI04AA02

INN:

inactivated bluetongue serotype 1+8 vaccine

therapeutic_group:

Sheep

therapeutic_area:

bluetongue virus, SHEEP, Inactivated viral vaccines

therapeutic_indication:

Active immunisation of sheep from 1.5 months of age to prevent viraemia caused by bluetongue virus, serotypes 1 and 8.Onset of immunity: 21 days after completion of the primary vaccination scheme.Duration of immunity: 12 months.

leaflet_short:

Revision: 6

authorization_status:

Authorised

authorization_date:

2011-03-14

PIL

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
ZULVAC 1+8 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+8 Ovis suspension for injection for sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 2 ml of vaccine contains:
ACTIVE SUBSTANCE:
Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
RP* ≥ 1
Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
RP* ≥ 1
*Relative Potency by a mice potency test compared to a reference
vaccine that was shown efficacious
in sheep.
ADJUVANT:
Aluminium hydroxide
4 mg (Al
3+
)
Saponin
0.4 mg
EXCIPIENT:
Thiomersal
0.2 mg
Off-white or pink liquid.
4.
INDICATION(S)
Active immunisation of sheep from 1.5 months of age for the
prevention* of viraemia caused by
Bluetongue virus, serotypes 1 and 8.
*(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.
18
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient increase in rectal temperature, not exceeding 1.2 °C, may
occur commonly during the 24
hours following vaccination.
Vaccination may be followed in most animals 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 reactions is defined using the following
c

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 1+8 Ovis suspension for injection for sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
RP* ≥ 1
Inactivated Bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
RP* ≥ 1
*Relative Potency by a mice potency test compared to a reference
vaccine that was shown efficacious
in sheep.
ADJUVANTS:
Aluminium hydroxide
4 mg (Al
3+
)
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
Active immunisation of sheep from 1.5 months of age for the
prevention* of viraemia caused by
Bluetongue virus, serotypes 1 and 8.
*(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.
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
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient increase in