VERORAB VACCINE

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

INACTIVATED RABIES VIRUS

Disponible depuis:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

DCI (Dénomination commune internationale):

INACTIVATED RABIES VIRUS

Unités en paquet:

01Units Units; 10 Units

Fabriqué par:

SANOFI PASTEUR

Résumé des caractéristiques du produit

1
MY/VER/0322/CCDSv9
1
NAME OF THE MEDICINAL PRODUCT
VERORAB, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN PREFILLED
SYRINGE RABIES
VACCINE, INACTIVATED
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 mL) contains:
Rabies virus*, WISTAR Rabies PM/WI38 1503-3M strain (inactivated)
….. ≥ 2.5 IU **
*
Produced in VERO cells
** Quantity measured according to the NIH test against the
international standard
Excipient with known effect:
Phenylalanine
....................................................................................................................41
micrograms
For the full list of excipients, see Section 6.1.
Verorab may contain traces of polymyxin B, streptomycin and neomycin,
used in the manufacturing
process (see section 4.3).
3
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection in prefilled syringe.
Before reconstitution, the powder is uniform white in colour.
The solvent is a clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VERORAB is indicated for pre-exposure and post-exposure prophylaxis of
rabies in all age groups
(see sections 4.2 and 5.1).
Verorab should be used according to official recommendations.
Pre-exposure prophylaxis should be offered to subjects at high risk of
contamination by the rabies viru
S.
All those at permanent risk, such as the personnel of diagnostic,
research or production laboratories
working on the rabies virus, should be vaccinated.
Vaccination is also recommended for the following categories:
•
chiropterologists and people regularly exposed to the bat rabies
virus.
•
exposed professionals (veterinary personnel, laboratory personnel
handling equipment that is
contaminated or likely to be contaminated, slaughterhouse butchers,
pound personnel, naturalists,
taxidermists, gamekeepers, forest rangers, slaughterhouse personnel).
•
adults and children living in or travelling to enzootic areas.
Booster doses are determined based on the risk of exposure and on
serological tests in accord