REPEVAX %v/v Suspension for Injection

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

TETANUS TOXOID DIPHTHERIA TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN POLIO VIRUS TYPE 1 INACTIVATED POLIO VIRUS TYPE 2 INACTIVATED POLIO VIRUS TYPE 3 INACTIVATED ADSORBED FIMBRIAE TYPES 2 + 3

Saadav alates:

Sanofi Pasteur MSD Ltd

INN (Rahvusvaheline Nimetus):

TETANUS TOXOID DIPHTHERIA TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN POLIO VIRUS TYPE 1 INACTIVATED

Annus:

%v/v

Ravimvorm:

Suspension for Injection

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Volitamisolek:

Authorised

Loa andmise kuupäev:

0000-00-00

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
REPEVAX, suspension for injection
Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced
antigen(s) content)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Diphtheria toxoid............................................................ Not less than 2 IU* (2 Lf)
Tetanus toxoid ............................................................ Not less than 20 IU* (5 Lf)
Pertussis antigens
Pertussis toxoid........................................................................... 2.5 micrograms
Filamentous haemagglutinin.......................................................... 5 micrograms
Pertactin...................................................................................... 3 micrograms
Fimbriae Types 2 and 3................................................................5 micrograms
Poliovirus (Inactivated)**
Type 1................................................................................. 40 D antigen units
Type 2 .................................................................................. 8 D antigen units
Type 3 ................................................................................. 32 D antigen units
Adsorbed on aluminium phosphate....................................................... 1.5 mg (0.33 mg aluminium)
*
As lower confidence limit (p = 0.95) of activity measured according to the assay described in the European Pharmacopoeia.
** Produced in Vero cells.
REPEVAX may contain traces of formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine
serum albumin, which are used during the manufacturing process (see sections 4.3 and 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in vial
REPEVAX appears as a uniform, clo