Nobivac Myxo-RHD PLUS Lyophilisate and Solvent for Suspension for Injection for Rabbits

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Myxoma vectored rabbit haemorrhagic disease virus (live)

Available from:

MSD Animal Health UK Limited

ATC code:

QI08AD

INN (International Name):

Myxoma vectored rabbit haemorrhagic disease virus (live)

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Rabbits

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2019-12-05

Summary of Product characteristics

Revised: October 2022
AN: 01329/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Revised: October 2022
AN: 01329/2022
Page 2 of 6
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.
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 com