Bluevac BTV (previously known as Bluevac BTV8)

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated]

Tillgänglig från:

CZ Veterinaria S.A.

ATC-kod:

QI04AA02

INN (International namn):

bluetongue virus inactivated, serotype 8

Terapeutisk grupp:

Sheep, Cattle

Terapiområde:

Immunologicals

Terapeutiska indikationer:

SheepActive immunisation against bluetongue virus serotype 8 to prevent viraemia and to reduce clinical signs.Onset of immunity: 20 days after second dose.Duration of immunity: 1 year after second dose.CattleActive immunisation against bluetongue virus serotype 8 to prevent viraemia.Onset of immunity: 31 days after second dose.Duration of immunity: 1 year after second dose.

Produktsammanfattning:

Revision: 7

Bemyndigande status:

Authorised

Tillstånd datum:

2011-04-14

Bipacksedel

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
BLUEVAC BTV 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
Marketing authorisation holder and manufacturer
responsible for batch release:
CZ Veterinaria, S.A.
La Relva s/n - Torneiros
36410 Porriño (Spain)
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BLUEVAC BTV Suspension for injection for cattle and sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated bluetongue virus (BTV)
One of the following inactivated bluetongue virus serotypes:
Inactivated bluetongue virus, serotype 1 (BTV-1), strain
BTV-1/ALG/2006/01
≥ 22.60 µg/ml
Inactivated bluetongue virus, serotype 4 (BTV-4), strain
BTV-4/SPA-1/2004
≥ 2.55 µg/ml
Inactivated bluetongue virus, serotype 8 (BTV-8), strain
BTV8/BEL/2006/01
≥ 55.80 µg/ml
ADJUVANTS:
Aluminium hydroxide
6 mg
Purified saponin (Quil A)
0.05 mg
EXCIPIENT:
Thiomersal
0.1 mg
The type of strain included in the final product will be selected
based on the epidemiological situation
at the time of manufacturing and will be stated on the label.
White or pinkish-white suspension.
4.
INDICATION(S)
Sheep
For active immunisation of sheep to prevent the viraemia* caused by
bluetongue virus serotype 1 or 4
or 8) and to reduce clinical signs caused by bluetongue virus serotype
8.
* Below the level of detection by the validated RT-PCR method at 1
log10 TCID
50
/ml for serotypes 8
and 4, and 1.3 log10
TCID
50
/ml for serotype 1
18
Onset of immunity:
21 days after completion of the primary vaccination scheme.
Duration of immunity:
1 year after completion of the primary vaccination scheme.
Cattle
For active immunisation of cattle to prevent viraemia* caused by
bluetongue virus serotype 1 or 4or 8
* Below the level of detection by the validated RT-PCR method at 1
log10 TCID
50
/ml for serotypes 8
and 4, and 1.3 log10
TCID
50
/ml for serotype 1.

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BLUEVAC BTV Suspension for injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated bluetongue virus (BTV)
One of the following inactivated bluetongue virus serotypes:
Inactivated bluetongue virus, serotype 1 (BTV-1), strain
BTV-1/ALG/2006/01
≥ 22.60 µg/ml
Inactivated bluetongue virus, serotype 4 (BTV-4), strain
BTV-4/SPA-1/2004
≥ 2.55 µg/ml
Inactivated bluetongue virus, serotype 8 (BTV-8), strain
BTV8/BEL/2006/01
≥ 55.80 µg/ml
ADJUVANTS:
Aluminium hydroxide
6 mg
Purified saponin (Quil A)
0.05 mg
EXCIPIENTS:
Thiomersal
0.1 mg
For the full list of excipients, see section 6.1.
The type of strain included in the final product will be selected
based on the epidemiological situation
at the time of manufacturing and will be stated on the label.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White or pinkish-white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sheep
For active immunisation of sheep to prevent the viraemia* caused by
bluetongue virus serotype 1 or 4
or 8) and to reduce clinical signs caused by bluetongue virus serotype
8
* Below the level of detection by the validated RT-PCR method at 1
log10 TCID
50
/ml for serotypes 8
and 4, and 1.3 log10
TCID
50
/ml for serotype 1.
Onset of immunity:
21 days after completion of the primary vaccination scheme.
3
Duration of immunity:
1 year after completion of the primary vaccination scheme.
Cattle
For active immunisation of cattle to prevent viraemia* caused by
bluetongue virus serotype 1 or 4 or 8.
*
Below the level of detection by the validated RT-PCR method at 1 log10
TCID
50
/ml for serotypes 8
and 4, and 1.3 log10
TCID
50
/ml for serotype 1.
Onset of immunity:
BTV, serotype 1: 28 days after completion of the primary vaccination
scheme
BTV, serotype 4: 21 days after completion of the primary vaccination
sche