Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis fimbriae 2 + 3,Pertussis toxoid,Poliovirus,Tetanus toxoid
Sanofi-Aventis Australia Pty Ltd
Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis fimbriae 2 + 3,Pertussis toxoid,Poliovirus,Tetanus to
Registered
1 ada-pol-ccdsv12-piv2-30jun20 AUSTRALIAN PRODUCT INFORMATION – ADACEL POLIO (PERTUSSIS VACCINE - ACELLULAR AND DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED) COMBINED WITH INACTIVATED POLIOVIRUS TYPE 1, 2 AND 3 (VERO CELL)) 1 NAME OF THE MEDICINE Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids (Adsorbed) Combined with Inactivated Poliovirus Type 1, 2 and 3 (Vero cell) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Adacel Polio is a sterile, uniform cloudy, white suspension for injection in prefilled syringes or vials. Each 0.5 mL dose of Adacel Polio contains: Diphtheria toxoid 2 IU (2 Lf) Tetanus toxoid 20 IU (5 Lf 1 ) Pertussis toxoid 2.5 micrograms Pertussis filamentous haemagglutinin 5 micrograms Pertactin 3 micrograms Pertussis fimbriae 2 + 3 5 micrograms Poliovirus inactivated type 1, Vero (Mahoney) 40 D antigen Units Poliovirus inactivated type 2, Vero (MEF1) 8 D antigen Units Poliovirus inactivated type 3, Vero (Saukett) 32 D antigen Units Adsorbed on aluminium phosphate 1.5 mg (0.33mg aluminium) 1 The formulated content of 5Lf of tetanus toxoid per 0.5 mL is the same as in the related product Tripacel®. This vaccine may contain traces of formaldehyde, glutaral, streptomycin sulfate, neomycin, polymyxin B sulfate and bovine serum albumin, and Medium 199 Hanks without phenol red (including phenylalanine), which are used during the manufacturing process. For the full list of excipients, see Section 6.1 List of excipients. 2 ada-pol-ccdsv12-piv2-30jun20 The vaccine is prepared from: purified formaldehyde-detoxified and adsorbed diphtheria and tetanus toxins; purified and glutaral-detoxified and adsorbed pertussis toxin (pertussis toxoid or PT); purified formaldehyde treated and adsorbed filamentous haemagglutinin (FHA); purified and adsorbed pertactin (PRN) and co-purified and adsorbed fimbriae types 2 and 3 (FIM); and poliomyelitis viruses type 1, 2 and 3 cultivated on Vero cells, purified and then inactivated by formaldehyde. Adacel Polio is a diphtheria-tetanus-acellular pertussis comb Olvassa el a teljes dokumentumot