Zulvac 8 Ovis

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02

Available from:

Zoetis Belgium SA

ATC code:

QI04AA02

INN (International Name):

inactivated bluetongue virus, serotype 8

Therapeutic group:

Sheep

Therapeutic area:

Immunologicals

Therapeutic indications:

Active immunisation of sheep from 1.5 months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2010-01-15

Patient Information leaflet

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
ZULVAC 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. de Camprodón, s/n°
Finca La Riba
Vall de Bianya
Gerona, 17813
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 8 Ovis suspension for injection for sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose of 2 ml of vaccine contains:
ACTIVE SUBSTANCE:
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(S):
Aluminium hydroxide (Al
3+
)
4 mg
Quil-A (
_Quillaja saponaria_
saponin extract)
0.4 mg
EXCIPIENT:
Thiomersal
0.2 mg
Off-white or pink suspension for injection.
4.
INDICATION(S)
Active immunisation of sheep from 1.5 months of age for the
prevention* of viraemia caused by bluetongue
virus, serotype 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating
no presence of viral genome).
18
Onset of immunity: 25 days after administration of the second dose.
Duration of immunity: at least 1 year after the primary vaccination
course.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient increase in rectal temperature during the 24 hours
following vaccination not exceeding 1.2°C and
local reaction at the injection site, in most cases in the form of a
general swelling (persisting for not more
than 7 days) or of palpable nodules (subcutaneous granuloma, possibly
persisting for more than 48 days)
were observed very commonly in one laboratory safety study. These
clinical signs have been reported very
rarely from the field.
The frequency of adverse reactions is defined using the following
convention:
- very

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 8 Ovis suspension for injection for sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 2 ml of vaccine contains:
ACTIVE SUBSTANCE:
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(S):
Aluminium hydroxide (Al
3+
)
4 mg
Quil-A (
_Quillaja saponaria_
saponin extract)
0.4 mg
EXCIPIENT:
Thiomersal
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Off-white or pink suspension for injection.
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, serotype 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating
no presence of viral genome).
Onset of immunity: 25 days after administration of the second dose.
Duration of immunity: at least 1 year after the primary vaccination
course.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
3
Use in other domestic and wild ruminant species that are considered at
risk of infection 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
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or the
label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)