Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
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
Sanofi Pasteur MSD Ltd
TETANUS TOXOID DIPHTHERIA TOXOID PERTUSSIS TOXOID FILAMENTOUS HAEMAGGLUTININ (FHA) PERTACTIN POLIO VIRUS TYPE 1 INACTIVATED
%v/v
Suspension for Injection
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
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 Prečítajte si celý dokument