Fatrovax RHD

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

Rabbit hemorrhagic disease virus 2 VP1AB, Rabbit hemorrhagic disease virus VP1A

Fáanlegur frá:

Fatro S.p.A

ATC númer:

QI08AA01

INN (Alþjóðlegt nafn):

Rabbit haemorrhagic disease vaccine (inactivated, recombinant)

Meðferðarhópur:

Rabbits

Lækningarsvæði:

Immunologicals for leporidae

Ábendingar:

For active immunisation of rabbits from the age of 28 days to reduce mortality, infection, clinical signs and organ lesions of rabbit haemorrhagic disease caused by RHDV1 and RHDV2.

Leyfisstaða:

Authorised

Leyfisdagur:

2021-08-16

Upplýsingar fylgiseðill

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
FATROVAX RHD 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:
FATRO S.p.A., Via Emilia 285, 40064 Ozzano dell’Emilia (BO), ITALY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FATROVAX RHD suspension for injection for rabbits
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each dose (0.5 ml) contains:
Active substances:
Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a* ≥1 RP**
Rabbit haemorrhagic disease virus 2 (RHDV2) VP1ab* ≥1 RP**
* recombinant capsid protein
** Relative potency: ELISA test by comparison with a reference serum
in vaccinated mice
Adjuvant:
Aluminium hydroxide (as Al
3+
)
Preservative:
Thiomersal
Whitish aqueous suspension with soft white sedimentation easily
resuspendable.
4.
INDICATION(S)
For active immunisation of rabbits from the age of 28 days to reduce
mortality, infection, clinical
signs and organ lesions of rabbit haemorrhagic disease caused by RHDV1
and RHDV2.
Onset of immunity: 1 week (7 days) after vaccination.
Duration of immunity: 1 year.
5.
CONTRAINDICATIONS
None.
20
6.
ADVERSE REACTIONS
A very small transient nodule at the site of injection may commonly be
visible or palpable in
the first week post vaccination in laboratory trials. In the repeated
dose laboratory trials, upon
necropsy small nodules in the subcutis at the injection site were
commonly observed.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, including
isolated repor

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FATROVAX RHD suspension for injection for rabbits
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.5 ml) contains:
ACTIVE SUBSTANCES
:
Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a*
≥1 RP**
Rabbit haemorrhagic disease virus 2 (RHDV2) VP1ab*
≥1 RP**
* recombinant capsid protein
** Relative potency: ELISA by comparison with a reference serum in
vaccinated mice
ADJUVANT:
Aluminium hydroxide (as Al
3+
)
0.83 mg
EXCIPIENTS:
Thiomersal
0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Whitish aqueous suspension with soft white sedimentation.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Rabbits, including pet (dwarf) rabbits
4.2
INDICATIONS FOR USE, SPECYFING THE TARGET SPECIES
For active immunisation of rabbits from the age of 28 days to reduce
mortality, infection,
clinical signs and organ lesions of rabbit haemorrhagic disease caused
by RHDV1 and
RHDV2.
Onset of immunity: 1 week (7 days) after vaccination.
Duration of immunity: 1 year.
4.3
CONTRAINDICATIONS
None.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
The possible interference of MDAs cannot be excluded at the
recommended age for
vaccination.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Pregnant does should be handled with special care to avoid stress and
risk of abortion.
The safety of reproductive performance in male rabbits was not
evaluated.
Special precautions to be taken by the person administering the
veterinary medicinal product
to animals
In case of accidental self-injection, seek medical advice immediately
and show the package
leaflet or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A very small transient nodule (maximum 5.2 mm diameter) at the site of
injection may
commonly be visible or palpable in the first week post vaccination, in
laboratory trials. In the
repeated dose laboratory trials, upon necro