Nobivac Myxo-RHD
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
25-03-2021
Karatteristiċi tal-prodott
(SPC)
25-03-2021
Rapport ta 'Valutazzjoni Pubblika
(PAR)
12-09-2023
Ingredjent attiv:
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009
Disponibbli minn:
Intervet International BV
Kodiċi ATC:
QI08AD
INN (Isem Internazzjonali):
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009
Grupp terapewtiku:
Rabbits
Żona terapewtika:
Immunologicals
Indikazzjonijiet terapewtiċi:
For active immunisation of rabbits from five weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease.Onset of immunity: 3 weeks.Duration of immunity: 1 year.
Sommarju tal-prodott:
Revision: 4
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2011-09-07
Fuljett ta 'informazzjoni
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET
Nobivac Myxo-RHD 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
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection
for rabbits
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of reconstituted vaccine contains:
Live myxoma vectored RHD virus strain 009:
≥
10
3.0
and
≤
10
6.1
FFU*
*Focus Forming Units
Lyophilisate: off-white or cream-coloured pellet.
Solvent: clear colourless solution.
Reconstituted product: off-pink or pink coloured suspension.
4.
INDICATION(S)
For active immunisation of rabbits to reduce mortality and clinical
signs of myxomatosis and to
prevent mortality due to rabbit haemorrhagic disease (RHD) caused by
classical RHD virus strains.
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 (max.
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, in very rare cases,
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 the appearance of mild clinical signs of myxomatosis may occur
within 3 weeks of vaccination.
Recent or latent infection with field myxoma virus seems to play a
role in this to a certain extent.
22
The frequency of adverse reactions is defined using the following
convention:
−
very common (more than 1 in 10 animals treated displaying adverse
reactions)
−
common (mo
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Karatteristiċi tal-prodott
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection
for rabbits
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Live myxoma vectored RHD virus strain 009:
≥
10
3.0
and
≤
10
6.1
FFU*
*Focus Forming Units
EXCIPIENTS:
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.
Reconstituted product: off-pink or pink coloured suspension.
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 to prevent mortality due to rabbit haemorrhagic
disease (RHD) caused by
classical RHD virus strains.
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy rabbits.
3
Rabbits that have been vaccinated previously with another myxomatosis
vaccine, or that have
experienced natural myxomatosis infection in the field, may not
develop a proper immune response
against rabbit haemorrhagic disease following vaccination.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
None.
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 site is commonly observed
within the first two weeks after
vaccination. The swelling will resolve completely by 3 weeks after
vaccination. In pet rabbits, in very
rare cases, local reactions at the injection site such as necrosis,
scabs, crusts or hair loss may occur. In
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