Fatrovax RHD Suspension for Injection for Rabbits

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Rabbit haemorrhagic disease virus

Available from:

Fatro S.p.A

ATC code:

QI08AA01

INN (International Name):

Rabbit haemorrhagic disease virus

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Rabbits

Therapeutic area:

Inactivated Viral Vaccine

Authorization status:

Authorized

Authorization date:

2021-09-21

Summary of Product characteristics

Issued: September 2021
AN: 01087/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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 type 2 (RHDV2) VP1ab* ≥1 RP**
* recombinant capsid protein
** Relative potency: ELISA by comparison with a reference serum
ADJUVANT:
Aluminium hydroxide (as Al
3+
)
0.83 mg
EXCIPIENTS:
Thiomersal
0.05 mg
For the full list of excipients, see section 6.1.
RP*: Relative potency (ELISA test) by comparison with a reference
serum
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 RHDV and RHDV2.
Onset of immunity: 1 week
Duration of immunity: 1 year
Issued: September 2021
AN: 01087/2019
Page 2 of 6
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Low levels of maternally derived antibodies against RHD virus do not
interfere
with vaccine efficacy. However, no information is available on the use
of the
vaccine in animals with high levels of maternally derived antibodies.
Thus, in
situations where a high level of maternally derived antibodies against
RHD
virus is expected, the vaccination scheme must be adjusted
accordingly.
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.
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 sho