VERORAB

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

RABIES, INACTIVATED, WHOLE VIRUS

Disponibil de la:

SANOFI ISRAEL LTD

Codul ATC:

J07BG01

Forma farmaceutică:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Compoziție:

RABIES, INACTIVATED, WHOLE VIRUS 2.5 IU

Calea de administrare:

I.M

Tip de prescriptie medicala:

Required

Produs de:

SANOFI PASTEUR, FRANCE

Grupul Terapeutică:

RABIES, INACTIVATED, WHOLE VIRUS

Zonă Terapeutică:

RABIES, INACTIVATED, WHOLE VIRUS

Indicații terapeutice:

Prevention of rabies in children and adults. It can be used before and after exposure, as a primary vaccination or as a booster dose.

Data de autorizare:

2014-06-30

Caracteristicilor produsului

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_ _
_VERO-PI-10.23 _
1. NAME OF THE MEDICINAL PRODUCT
Verorab, powder and solvent for suspension for injection
Rabies vaccine, inactivated
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, with 0.5 mL of solvent, 1 vial 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 effects:
Phenylalanine
...................................................................................................................
4.1 micrograms
For the full list of excipients, see section 6.1.
Verorab may contain traces of polymyxin B, streptomycin, and neomycin,
which are used in the manufacturing process
(see section 4.3).
3.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
Before reconstitution, the powder is a uniform white colour.
The solvent is a clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Verorab is indicated for the prevention of rabies in children and
adults. It can be used before and after exposure to the
rabies virus, as a primary vaccination or as a booster dose.
Pre-Exposure Prevention of Rabies (Pre-Exposure Vaccination)
Pre-exposure vaccination should be offered to subjects at high risk of
contamination by the rabies virus.
All those at permanent risk, such as the personnel of a diagnostic,
research or production laboratory working with the
rabies virus, should be vaccinated. A serological test is recommended
every 6 months (see section 4.4)
.
Pre-exposure vaccination should also be considered for subjects at
frequent risk of exposure to the rabies virus, such
as
:
-
veterinarians, veterinarians’ assistants, and animal handlers
-
those who, either by profession or leisure activity, are in contact
with species such as dogs, cats, skunks,
raccoons, bats or other species likely to have rabies. Examples of
such people are gamekeepers, hunt