Zulvac 1+8 Bovis

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02

MAH:

Zoetis Belgium SA

ATC_code:

QI02AA08

INN:

inactivated bluetongue virus, serotypes 1 and 8

therapeutic_group:

Cattle

therapeutic_area:

bluetongue virus, Immunologicals, Immunologicals for bovidae, Cattle, Inactivated viral vaccines

therapeutic_indication:

Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1 and 8.*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).

leaflet_short:

Revision: 6

authorization_status:

Authorised

authorization_date:

2012-03-08

PIL

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
ZULVAC 1+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. Camprodón s/n "la Riba"
17813 Vall de Bianya
Girona
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 1+8 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
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
4 mg (Al
3+
)
Saponin
1 mg
EXCIPIENT:
Thiomersal
0.2 mg
4.
INDICATION(S)
For active immunisation of cattle from 3 months of age for the
prevention* of viraemia caused by
bluetongue virus (BTV), 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
course.
Duration of immunity: 12 months after completion of the primary
vaccination course.
18
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient increase in rectal temperature, not exceeding 2.7 C, was
commonly observed during the 48
hours following vaccination in field safety studies.
Local reactions of < 2 cm diameter were very commonly observed while
reactions of up to 5cm
diameter were commonly observed after administration of a single dose
in field safety studies. These
resolved within a maximum of 25 days. Local reactions may increase
slightly following the second
dose in this case lasting up to 15 days. Local reactions of up to 5 cm
diameter we

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zulvac 1+8 Bovis suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCE(S):
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 cattle.
ADJUVANT(S):
Aluminium hydroxide
4 mg (Al
3+
)
Saponin
1 mg
EXCIPIENT(S):
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 3 months of age for the
prevention* of viraemia caused by
bluetongue virus (BTV), 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
course
Duration of immunity: 12 months after completion of the primary
vaccination course.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No information is available on the use of the vaccine in seropositive
animals including those with
maternally derived antibodies.
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
3
of animals prior to mass vaccination. The level of efficacy for other
species may differ from that
observed in cattle.
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)
A transient increase in rectal