Nobivac Myxo-RHD Plus

País: União Europeia

Língua: inglês

Origem: EMA (European Medicines Agency)

Ingredientes ativos:

Live myxoma vectored RHD virus strain 009, Live myxoma vectored RHD virus strain MK1899

Disponível em:

Intervet International B.V.

Código ATC:

QI08AD

DCI (Denominação Comum Internacional):

myxomatosis and rabbit haemorrhagic viral disease vaccine (live recombinant)

Grupo terapêutico:

Rabbits

Área terapêutica:

Immunologicals for leporidae

Indicações terapêuticas:

For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2).

Status de autorização:

Authorised

Data de autorização:

2019-11-19

Folheto informativo - Bula

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
Nobivac Myxo-RHD PLUS
lyophilisate and solvent for suspension for injection for rabbits
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:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for
injection for rabbits
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
Live myxoma vectored RHD virus strain 009: 10
3.0
- 10
5.8
FFU *
Live myxoma vectored RHD virus strain MK1899: 10
3.0
- 10
5.8
FFU*
*Focus Forming Units
Lyophilisate: off-white or cream-coloured pellet.
Solvent: clear colourless solution.
4.
INDICATION(S)
For active immunisation of rabbits from 5 weeks of age onwards to
reduce mortality and clinical signs
of myxomatosis and rabbit haemorrhagic disease (RHD) caused by
classical RHD virus (RHDV1) and
RHD type 2 virus (RHDV2).
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient temperature increase of 1–2 °C can commonly occur. A
small, non-painful swelling
(maximum 2 cm diameter) at the injection site is commonly observed
within the first two weeks after
vaccination. The swelling will resolve completely by 3 weeks after
vaccination. In pet rabbits, local
reactions at the injection site such as necrosis, scabs, crusts or
hair loss may occur in very rare cases.
Serious hypersensitivity reactions, which may be fatal, may occur
after vaccination in very rare cases.
19
The appearance of mild clinical signs of myxomatosis may occur within
3 weeks of vaccination in
very rare cases. Recent or latent infection with field myxoma virus
seems to play a role in this to a
certain extent.
The frequency of adverse reactions i

Características técnicas

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for
injection for rabbits
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Live myxoma vectored RHD virus strain 009: 10
3.0
- 10
5.8
FFU*
Live myxoma vectored RHD virus strain MK1899: 10
3.0
- 10
5.8
FFU*
*Focus Forming Units
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white or cream-coloured pellet.
Solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Rabbits.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of rabbits from 5 weeks of age onwards to
reduce mortality and clinical signs
of myxomatosis and rabbit haemorrhagic disease (RHD) caused by
classical RHD virus (RHDV1) and
RHD type 2 virus (RHDV2).
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
High levels of maternally derived antibodies against myxoma virus
and/or RHD virus can potentially
reduce the efficacy of the product. To ensure the full duration of
immunity, vaccination from 7 weeks
of age is advised in this case.
Rabbits that have been vaccinated previously with another myxomatosis
vaccine, or that have
experienced natural myxomatosis infection in the field, may not
develop an adequate immune
response against rabbit haemorrhagic disease following vaccination.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient temperature increase of 1 – 2 °C can commonly occur. A
small, non-painful swelling
(maximum 2 cm diameter) at the injection si