Anivac VHD Suspension for Injection for Rabbits

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: VMD (Veterinary Medicines Directorate)

Veiklioji medžiaga:

Rabbit hemorrhagic disease virus

Prieinama:

Pharmagal Bio s. r .o.

INN (Tarptautinis Pavadinimas):

Rabbit hemorrhagic disease virus

Vaisto forma:

Suspension for injection

Recepto tipas:

POM-V - Prescription Only Medicine – Veterinarian

Farmakoterapinė grupė:

Rabbits

Gydymo sritis:

Inactivated Viral Vaccine

Autorizacija statusas:

Authorized

Leidimo data:

2008-10-17

Prekės savybės

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