Anivac VHD Suspension for injection for rabbits

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Rabbit haemorrhagic disease, strain RHDV PHB 98

Disponible depuis:

Pharmagal Bio s.r.o

Code ATC:

QI08AA01

DCI (Dénomination commune internationale):

Rabbit haemorrhagic disease, strain RHDV PHB 98

Dosage:

minimum 1 PD90

forme pharmaceutique:

Suspension for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Rabbits

Domaine thérapeutique:

rabbit haemorrhagic disease virus

indications thérapeutiques:

Immunological - Inactivated Vaccine

Statut de autorisation:

Authorised

Date de l'autorisation:

2008-11-10

Résumé des caractéristiques du produit

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 CONTRAINDICATIONS
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.
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