Zulvac 8 Bovis

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

ATC code:

QI02AA08

INN (International Name):

inactivated bluetongue virus, serotype 8

Therapeutic group:

Cattle

Therapeutic area:

Immunologicals

Therapeutic indications:

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

Product summary:

Revision: 7

Authorization status:

Withdrawn

Authorization date:

2010-01-15

Patient Information leaflet

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET FOR:
ZULVAC 8 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. Camprodon s/n "la Riba"
17813 Vall de Bianya
Girona
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZULVAC 8 Bovis suspension for injection for cattle
3.
STATEMENT
OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose of 2 ml of vaccine contains:
Inactivated blue
T
ongue 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
cattle.
ADJUVANTS:
Aluminium hydroxide (Al
3+
)
4 mg
Saponin
0.4 mg
EXCIPIENT:
Thiomersal
0.2 mg
4.
INDICATION(S)
Active immunisation of cattle from 3 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.
The duration of immunity is at least 1 year after the primary
vaccination course.
18
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
In one laboratory safety study, no adverse reactions were observed
after the first injection of a single dose of
vaccine to calves.
After the second injection of a single dose, a slight and transient
but significant increase in the mean rectal
temperature of 0.4ºC was very commonly recorded in the vaccinated
calves during the first 24 hours. On day
2 after vaccination, rectal temperatures had returned to normal
values. This clinical sign has been reported
very rarely from the field.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals displaying adverse
reaction(s)

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZULVAC 8 Bovis suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each dose of 2 ml of the 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
cattle.
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
Off-white or pink suspension for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cattle from 3 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.
The duration of immunity is at least 1 year after the primary
vaccination course.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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
cattle.
3
No information is available on the use of the vaccine in animals with
maternally derived antibodies however
the vaccine has been shown safe and efficacious in seropositive
cattle.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only use in 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)
In one laboratory safety study, no adverse reactions were observed
after the first injection of a single dose