País: Israel
Idioma: anglès
Font: Ministry of Health
RABIES, INACTIVATED, WHOLE VIRUS
SANOFI ISRAEL LTD
J07BG01
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
RABIES, INACTIVATED, WHOLE VIRUS 2.5 IU
I.M
Required
SANOFI PASTEUR, FRANCE
RABIES, INACTIVATED, WHOLE VIRUS
RABIES, INACTIVATED, WHOLE VIRUS
Prevention of rabies in children and adults. It can be used before and after exposure, as a primary vaccination or as a booster dose.
2014-06-30
Page _1_ of 9 _ _ _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 Llegiu el document complet