Bovilis Blue-8

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

bluetongue virus vaccine, serotype 8 (inactivated)

Available from:

Intervet International B.V.

ATC code:

QI04AA02

INN (International Name):

bluetongue virus vaccine (inactivated) serotype 8

Therapeutic group:

Cattle; Sheep

Therapeutic area:

Immunologicals for ovidae

Therapeutic indications:

SheepFor the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.CattleFor the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2017-11-21

Patient Information leaflet

16
B. PACKAGE LEAFLET
page 16 of 20
17
PACKAGE LEAFLET:
BOVILIS BLUE-8 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 Blue-8 suspension for injection for cattle and sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml of vaccine contains:
Bluetongue virus inactivated, serotype 8
10
6.5
CCID
50
*
Aluminium hydroxide
6 mg
Purified saponin (Quil A)
0.05 mg
Thiomersal
0.1 mg
(* equivalent to titre prior to inactivation)
4.
INDICATION(S)
Sheep
For the active immunisation of sheep from 2.5 months of age to prevent
viraemia* and to reduce
clinical signs 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:
20 days after the second dose.
Duration of immunity:
1 year after the second dose.
Cattle
For the active immunisation of cattle from 2.5 months of age to
prevent 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:
31 days after the second dose.
Duration of immunity:
1 year after the second dose.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
An average increase in body temperature varying between 0.5 and 1.0
ºC is a common reaction
observed in sheep and cattle. It lasted not longer than 24 to 48
hours. Transient fever was observed in
rare cases. Temporary local reactions can occur very rarely at the
injection site in the form of a nodule
page 17 of 20
18
of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears
within 14 days, at the latest and
which may be painful. Loss of appetite can occur in very rare cases.
Hypersensitivity reactions are
very rarely observed.
The frequency of adverse re

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
page 1 of 20
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Blue-8 suspension for injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of vaccine contains:
ACTIVE SUBSTANCE:
Bluetongue virus inactivated, serotype 8: 10
6.5
CCID
50
*
(* equivalent to titre prior to inactivation)
ADJUVANTS:
Aluminium hydroxide
6 mg
Purified saponin (Quil A) 0.05 mg
EXCIPIENT:
Thiomersal
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White or pinkish-white.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sheep
For the active immunisation of sheep from 2.5 months of age to prevent
viraemia* and to reduce
clinical signs 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:
20 days after the second dose.
Duration of immunity:
1 year after the second dose.
Cattle
For the active immunisation of cattle from 2.5 months of age to
prevent 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:
31 days after the second dose.
Duration of immunity:
1 year after the second dose.
4.3
CONTRAINDICATIONS
None.
page 2 of 20
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Occasionally, the presence of maternally derived antibodies in ovines
of minimum recommended age
might interfere with the protection induced by the vaccine.
No information is available on the use of the vaccine in seropositive
bovines, 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
of animals prior to mass vaccination. The level of