BTVPUR
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
27-10-2020
Karatteristiċi tal-prodott
(SPC)
27-10-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
18-10-2018
Ingredjent attiv:
bluetongue-virus serotype-1 antigen, bluetongue virus serotype 8 antigen
Disponibbli minn:
Boehringer Ingelheim Vetmedica GmbH
Kodiċi ATC:
QI04AA02, QI02AA08
INN (Isem Internazzjonali):
inactivated vaccine against bluetongue virus serotypes 1 and 8
Grupp terapewtiku:
Sheep; Cattle
Żona terapewtika:
Immunologicals
Indikazzjonijiet terapewtiċi:
SheepActive immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/ or 8 (combination of maximum 2 serotypes), active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1,2, 4 and/ or 8 (combination of maximum 2 serotypes), active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).CattleActive immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1, 2, 4 and/ or 8, and to reduce clinical signs caused by bluetongue virus serotypes when observed in this species: serotype 1, 4 and / or 8 (combination of maximum 2 serotypes).Active immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1, 2, 4 and/ or 8, and to reduce clinical signs caused by bluetongue virus serotypes when observed in this species: serotype 1, 4 and / or 8 (combination of maximum 2 serotypes).Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).
Sommarju tal-prodott:
Revision: 12
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2010-12-17
Fuljett ta 'informazzjoni
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
BTVPUR SUSPENSION FOR INJECTION FOR SHEEP AND 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:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
69800 Saint-Priest
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR suspension for injection for sheep and cattle
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
ACTIVE SUBSTANCE*:
Inactivated Bluetongue Virus .........................................
≥
strain specific pass level (log
10
pixels) **
* maximum of two different inactivated bluetongue virus serotypes
(**)Strain-specific
pass levels
(**) Antigen content (VP2
protein) by immuno-assay
BTV1
1.9 log10 pixels/mL
BTV2
1.82 log10 pixels/mL
BTV4
1.86 log10 pixels/mL
BTV8
2.12 log10 pixels/mL
A confirmatory final potency test by seroneutralisation in rats is
conducted when a batch is released.
ADJUVANTS:
Al3+ (as hydroxide)
..................................................................................................................
2.7 mg
Saponin
...................................................................................................................................
30 HU**
(
**
)
Haemolytic units
The type of strain(s) (two strains at most) 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.
Appearance: homogeneous milky white.
20
4.
INDICATION(S)
Active immunisation of sheep to prevent viraemia* and to reduce
clinical signs caused by Bluetongue
Virus Serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).
Active immunisation of cattle to prevent viraemia* caused by
bluetongue virus serotypes 1, 2, 4 and/or
8, and to r
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR suspension for injection for sheep and cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES *:
Inactivated bluetongue virus ........................................
≥
strain specific pass level (log10 pixels) **
(*) maximum of two different inactivated bluetongue virus serotypes
(**)Strain-specific
pass levels
(**) Antigen content (VP2
protein) by immuno-assay
BTV1
1.9 log10 pixels/mL
BTV2
1.82 log10 pixels/mL
BTV4
1.86 log10 pixels/mL
BTV8
2.12 log10 pixels/mL
A confirmatory final potency test by seroneutralisation in rats is
conducted when a batch is released.
ADJUVANTS:
Al
3+
(as hydroxide)
2.7 mg
Saponin
30 HU**
(
**
)
Haemolytic units
For the full list of excipients, see section 6.1.
The type of strain(s) (two strains at most) 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
Appearance: homogeneous milky white .
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of sheep to prevent viraemia* and to reduce
clinical signs caused by bluetongue
virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).
Active immunisation of cattle to prevent viraemia* caused by
bluetongue virus serotypes 1, 2, 4 and/or
8, and to reduce clinical signs caused by bluetongue virus serotypes
1, 4 and/or 8 (combination of
maximum 2 serotypes).
*below the level of detection by the validated RT-PCR method at 3.68
log
10
RNA copies/ml,
indicating no infectious virus transmission.
3
Onset of immunity has been demonstrated 3 weeks (or 5 weeks in sheep
for BTV2) after the primary
vaccination course
for BTV-1, BTV-2 (cattle), BTV-4 and BTV-8 serotypes.
The duration of immunity for cattle and sheep is 1 year after primary
vaccination course.
4.3
CONTRAINDICATIO
Aqra d-dokument sħiħ
