Bovela

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI02AD02

INN (International Name):

bovine viral diarrhoea vaccine (modified live)

Therapeutic area:

Immunologicals for bovidae, Live viral vaccines

Therapeutic indications:

For active immunisation of cattle from 3 months of age to reduce hyperthermia and to minimise the reduction of leukocyte count caused by bovine viral diarrhoea virus (BVDV-1 and BVDV-2), and to reduce virus shedding and viraemia caused by BVDV-2.For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2014-12-22

Patient Information leaflet

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
BOVELA LYOPHILISATE AND SOLVENT FOR 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 and manufacturer responsible for batch
release:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovela lyophilisate and solvent for suspension for injection for
cattle
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (2 ml) contains:
Lyophilisate:
Modified live BVDV*-1, non-cytopathic parent strain KE-9:
10
4.0
–10
6.0
TCID
50
**,
Modified live BVDV
_*_
-2, non-cytopathic parent strain NY-93:
10
4.0
–10
6.0
TCID
50
**.
*
Bovine viral diarrhoea virus
**
Tissue culture infectious dose 50%
Lyophilisate: Off-white colour without foreign matter.
Solvent: Clear, colourless solution.
4.
INDICATION(S)
For active immunisation of cattle from 3 months of age to reduce
hyperthermia and to minimise the
reduction of leukocyte count caused by bovine viral diarrhoea virus
(BVDV-1 and BVDV-2), and to
reduce virus shedding and viraemia caused by BVDV-2.
For active immunisation of cattle against BVDV-1 and BVDV-2, to
prevent the birth of persistently
infected calves caused by transplacental infection.
Onset of immunity:
3 weeks after immunisation.
Duration of immunity:
1 year after immunisation.
5.
CONTRAINDICATION
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
6.
ADVERSE REACTIONS
An increase in body temperature within the physiological range is
common within 4 hours of
vaccination and spontaneously resolves within 24 hours (clinical
studies).
Mild swellings or nodules up to 3 cm diameter were observed at the
injection site and disappeared
within 4 days post vaccination (clinical studies).
20
Hypersensitivity reactions, including anaphylactic-type reactions,
have been reported very rarely
(post-marketing saf

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovela lyophilisate and solvent for suspension for injection for
cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
Lyophilisate:
ACTIVE SUBSTANCES:
Modified live BVDV*-1, non-cytopathic parent strain KE-9:
10
4.0
–10
6.0
TCID
50
**,
Modified live BVDV
_*_
-2, non-cytopathic parent strain NY-93:
10
4.0
–10
6.0
TCID
50
**.
*
Bovine viral diarrhoea virus
**
Tissue culture infectious dose 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
Lyophilisate: Off-white colour without foreign matter.
Solvent: Clear, colourless solution.
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 to reduce
hyperthermia and to minimise the
reduction of leukocyte count caused by bovine viral diarrhoea virus
(BVDV-1 and BVDV-2), and to
reduce virus shedding and viraemia caused by BVDV-2.
For active immunisation of cattle against BVDV-1 and BVDV-2, to
prevent the birth of persistently
infected calves caused by transplacental infection.
Onset of immunity:
3 weeks after immunisation.
Duration of immunity:
1 year after immunisation.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
To ensure the protection of animals introduced to the herd where BVDV
is circulating, vaccination has
to be completed 3 weeks before introduction.
3
The cornerstone of bovine viral diarrhoea (BVD)-eradication is
identification and culling of
persistently infected animals. A definitive diagnosis of persistent
infection can only be established
upon re-testing in blood after an interval of at least 3 weeks. In
some limited cases with newborn
calves, positive ear notches for BVDV vaccine strain were reported by
molecular