ANIVAC VHD SUSPENSION FOR INJECTION FOR RABBITS

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

RABBIT HAEMORRHAGIC DISEASE VIRUS, STRAIN PHB 98

Tilgængelig fra:

Pharmagal Bio s.r.o

ATC-kode:

QI08AA01

INN (International Name):

RABBIT HAEMORRHAGIC DISEASE VIRUS, STRAIN PHB 98

Dosering:

1

Lægemiddelform:

Suspension for Injection

Recept type:

POM

Terapeutisk gruppe:

Rabbits

Terapeutisk område:

Rabbit haemorrhagic disease virus vaccine

Terapeutiske indikationer:

Immunological - Inactivated vaccine

Autorisation status:

Authorised

Autorisation dato:

2008-11-10

Produktets egenskaber

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 23/10/2015_
_CRN 7020182_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not vaccin