Nobivac Myxo

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Rabbit fibroma virus

Available from:

Intervet UK Ltd

ATC code:

QI08AD01

INN (International Name):

Rabbit fibroma virus

Authorization status:

Expired

Summary of Product characteristics

Revised 08 June 2010
AN. 01604/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Myxo
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
PER DOSE 1 ML RECONSTITUTED PRODUCT:
Shope fibroma virus

10
3.0
and

10
4.9
pfu
3
PHARMACEUTICAL FORM
Lyophilisate for suspension for injection.
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Rabbits
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
As an aid in the prevention of myxomatosis in rabbits.
Onset of immunity: The onset of immunity was established as two weeks
after
vaccination.
Duration of immunity: The duration of immunity was established as 6
months.
4.3
CONTRAINDICATIONS
Do not vaccinate unhealthy animals. The vaccine may not be effective
in rabbits
incubating the disease at the time of vaccination. Some animals may be
immunologically incompetent and fail to respond to vaccination.
Do not use in animals intended for human consumption.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN
BY THE PERSON
ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS.
4.5.1 Special precautions for use in animals
If a rabbit with a degree of immunity is heavily challenged with
myxomatosis, then
atypical myxomatosis (‘lumpy bunny syndrome’) may be observed. In
these instances,
the rabbits do not develop typical clinical signs of myxomatosis, only
the dermal lesions
(hence ‘lumpy bunny syndrome’). Prognosis for recovery from
atypical myxomatosis is
good, although may be protracted, providing concomitant problems such
as stress,
pasteurellosis, etc, do not interfere.
The vaccine virus may spread to susceptible in-contact rabbits.
Revised 08 June 2010
AN. 01604/2009
4.5.2 Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Particular care should be taken to avoid self-injection when
administering intradermal
inoculations.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Following vaccination a small