Bovilis BTV8

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

bluetongue virus vaccine, serotype 8 (inactivated)

MAH:

Intervet International BV

ATC_code:

QI04AA02

INN:

bluetongue virus serotype 8

therapeutic_group:

Sheep; Cattle

therapeutic_area:

Inactivated viral vaccines, bluetongue virus, SHEEP

therapeutic_indication:

Cattle To stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia Sheep To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia,

leaflet_short:

Revision: 4

authorization_status:

Withdrawn

authorization_date:

2010-09-06

PIL

16
B. PACKAGE LEAFLET
Medicinal product no longer authorised
17
PACKAGE LEAFLET FOR:
BOVILIS BTV8 SUSPENSION FOR INJECTION FOR CATTLE AND SHEEP
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The NETHERLANDS
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis BTV8 suspension for injection for cattle and sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose (1 ml) contains:
Active ingredient: bluetongue virus serotype 8: 500 antigenic units*
(* inducing a virus neutralising antibody response in chickens of ≥
5.0 log
2
)
Adjuvants: aluminium hydroxide, saponin.
Opalescent pink with resuspendable sediment.
4.
INDICATION(S)
Sheep
To stimulate active immunity in sheep from 1 month of age against
bluetongue virus serotype 8 to
prevent viraemia
*
.
*(cycling value (Ct) > 30 by a validated rRT-PCR method, indicating
absence of infectious virus)
Cattle
To stimulate active immunity in cattle from 6 weeks of age against
bluetongue virus serotype 8 to
reduce viraemia*.
* (for details see section 12)
Onset of immunity:
3 weeks after vaccination.
Duration of immunity:
6 months.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
In very rare cases vaccination may result in a slight rise in
temperature (usually not more than 0.5 °C,
in individual cases up to about 2 °C) for up to three days after
vaccination, and temporary swellings at
the injection site. In sheep, these swellings typically last for up to
three weeks, while in cattle small
palpable swellings may still be present up to six weeks after
vaccination in approximately one third of
Medicinal product no longer authorised
18
vaccinates. After administration of a double dose in cattle and sheep
no other reactions were observed.
However, the temperature rise may be 0.5 °C higher and the swellings
may be more pronounced and
palpable for a longer period. In sheep, swellings may still b

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis BTV8 suspension for injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (1 ml) contains:
ACTIVE SUBSTANCE:
Bluetongue virus serotype 8 (prior to inactivation): 500 antigenic
units*.
(* inducing a virus neutralising antibody response in chickens of ≥
5.0 log
2
)
ADJUVANTS
Aluminium hydroxide (as 100%)
16.7 mg
Saponin
0.31 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Opalescent pink with resuspendable sediment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sheep
To stimulate active immunity in sheep from 1 month of age against
bluetongue virus serotype 8 to
prevent viraemia
*
.
*(cycling value (Ct) > 30 by a validated rRT-PCR method, indicating
absence of infectious virus)
Cattle
To stimulate active immunity in cattle from 6 weeks of age against
bluetongue virus serotype 8 to
reduce viraemia*.
* (for details see section 4.4)
Onset of immunity:
3 weeks after vaccination.
Duration of immunity:
6 months.
4.3
CONTRAINDICATIONS
None.
Medicinal product no longer authorised
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
This vaccine has been shown to reduce but not prevent viraemia in
cattle. The extent of this reduction
has been shown by epidemiological modelling studies to be likely to
reduce virus transmission to an
extent that can limit the spread of an outbreak in a vaccinated
population.
This vaccine has been tested
for safety in sheep and cattle. 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 and cattle.
No information is available on the use of th