Anivac VHD Suspension for Injection for Rabbits

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Rabbit hemorrhagic disease virus

Διαθέσιμο από:

Pharmagal Bio s. r .o.

INN (Διεθνής Όνομα):

Rabbit hemorrhagic disease virus

Φαρμακοτεχνική μορφή:

Suspension for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Rabbits

Θεραπευτική περιοχή:

Inactivated Viral Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2008-10-17

Αρχείο Π.Χ.Π.

Revised: October 2015
AN: 01469/2014
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Anivac VHD Suspension for injection for rabbits
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of vaccine (0.5 ml) contains:
_Active substances:_
Inactivated Rabbit Haemorrhagic Disease Virus strain RHDV PHB98
……min. 1 PD
90
*
_Adjuvant:_
Aluminium hydroxide gel
.................................................................................
1.3 mg
_Excipients:_
Formaldehyde
………………………………………………………………
0.55 mg
Thiomersal
………………………………………………………………
0.05 mg
For a full list of excipients, see section 6.1.
* Protective dose for minimum 90% of vaccinated animals
3.
PHARMACEUTICAL FORM
Suspension for injection.
Suspension of red-brown colour with easily shakeable sediment of
inactivated RHDV
adsorbed on aluminium hydroxide gel that forms 40-60% of the vaccine
if left undisturbed.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Rabbit.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of rabbits to prevent mortality caused by RHD
virus
Onset of immunity: 7 days
Duration of immunity: 1 year based on field data without controlled
challenge
4.3.
CONTRA-INDICATIONS
None.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No information is available on the use of the vaccine in seropositive
animals including
those with maternally derived antibodies; therefore in situations
where high antibody levels
are expected the vaccination protocol should be planned accordingly.
Revised: October 2015
AN: 01469/2014
Page 2 of 4
4.5.
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not vaccinate unhealthy animals.
It is recommended not to vaccinate in the later stages of pregnancy in
order to avoid stress
and handling of pregnant does.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT
TO ANIMALS
In case of accidental self-injection, seek me