FILAVAC VHD K C+V Suspension for Injection for Rabbits

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)

Aktīvā sastāvdaļa:

Rabbit haemorrhagic disease virus, Rabbit haemorrhagic disease virus type 2

Pieejams no:

Filavie

ATĶ kods:

QI08AA01

SNN (starptautisko nepatentēto nosaukumu):

Rabbit haemorrhagic disease virus, Rabbit haemorrhagic disease virus type 2

Zāļu forma:

Suspension for injection

Receptes veids:

POM-V - Prescription Only Medicine – Veterinarian

Ārstniecības grupa:

Rabbits

Ārstniecības joma:

Inactivated Viral Vaccine

Autorizācija statuss:

Authorized

Autorizācija datums:

2017-04-24

Produkta apraksts

Revised: October 2020
AN: 00198/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FILAVAC VHD K C+V SUSPENSION FOR INJECTION FOR RABBITS.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.5 ml) of vaccine contains:
Active substances:
Rabbit haemorrhagic disease virus strain LP.SV.2012 (variant strain
2010, RHDV2),
inactivated…………………….……………………………………………………….min
1
PD90% *
Rabbit haemorrhagic disease virus strain IM507.SC.2011 (classical
strain, RHDV1),
inactivated……………………………………………………………………….…….min
1
PD90% *
Adjuvant:
Aluminium hydroxide
…………………………………….…………..…………0.35
mg
(*) Protective dose in at least 90% of the vaccinated animals.
Excipients:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Reddish homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Rabbits
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of rabbits from 10 weeks of age, to reduce
mortality due to
rabbit haemorrhagic disease caused by classical (RHDV1) and type 2
(RHDV2) virus
strains.
Onset of immunity: 1 week.
Duration of immunity: 1 year.
Revised: October 2020
AN: 00198/2020
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
No information is available on the use of the vaccine in seropositive
animals,
including animals with maternally derived antibodies. Thus, in
situations where a high
level
of
antibodies
is
expected,
the
vaccination
scheme
must
be
adjusted
accordingly.
The efficacy of the vaccine in animals younger than 10 weeks of age
has not been
demonstrated.
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
In case of accidental self-