ADACEL POLIO pertussis vaccine - acellular, diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus 0.5mL

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis fimbriae 2 + 3,Pertussis toxoid,Poliovirus,Tetanus toxoid

Fáanlegur frá:

Sanofi-Aventis Australia Pty Ltd

INN (Alþjóðlegt nafn):

Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis fimbriae 2 + 3,Pertussis toxoid,Poliovirus,Tetanus to

Leyfisstaða:

Registered

Vara einkenni

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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