Adacel Polio

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

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

Boleh didapati daripada:

Sanofi-Aventis Australia Pty Ltd

Kelas:

Medicine Registered

Risalah maklumat

ADACEL
®
 POLIO

_Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids
(Adsorbed) Combined with Inactivated_
_Poliovirus Type 1, 2 and 3 (Vero cell)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ADACEL
®
 POLIO.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your doctor
has weighed the risks of you or your
child having ADACEL
®
 POLIO
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINE, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ADACEL
®
 POLIO
IS USED FOR
ADACEL
®
 POLIO is a vaccine used
to help prevent whooping cough
(pertussis), tetanus, diphtheria and
polio.
This vaccine is for use as a booster in
adults, adolescents and children aged
four years and older who have
previously received childhood
immunisation.
Children from four to six years of
age should have already received
four doses of whooping cough,
tetanus, diphtheria and polio vaccine.
ADACEL
®
 POLIO is not intended
for primary immunisation.
The use of ADACEL
®
 POLIO
should be determined on the basis of
official recommendations and by
your doctor.
Polio, whooping cough, tetanus and
diphtheria cause significant sickness
and sometimes death in unvaccinated
infants, children, and adults.
_HOW IT WORKS_
ADACEL
®
 POLIO works by causing
the body to produce its own
protection against whooping cough,
tetanus, diphtheria, and polio. It does
this by making substances called
antibodies in the blood, which fight
the bacteria and toxins that cause
these diseases. If a vaccinated person
comes into contact with these
bacteria and toxins, the body is
usually ready to destroy them.
It usually takes several weeks after
vaccination to develop protection
against these diseases.
A course of whooping cough,
tetanus, diphtheria and polio vaccine
is usually

Ciri produk

ADACEL POLIO Product Information 

Page 1 of 14 
AUSTRALIAN PRODUCT INFORMATION 
NAME OF THE DRUG 
ADACEL
®
 POLIO 
Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids
(Adsorbed) Combined with 
Inactivated Poliovirus Type 1, 2 and 3 (Vero cell) 
DESCRIPTION 
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: 
2.5 µg 
pertussis toxoid  
5 µg 
pertussis filamentous haemagglutinin 
5 µg 
pertussis fimbriae types 2 and 3  
3 µg 
pertussis pertactin 

2 IU (2 LfU) 
diphtheria toxoid 

20 IU (5 LfU
a
) 
tetanus toxoid 
40 DagU 
poliovirus inactivated type 1, Vero (Mahoney) 
8 DagU 
poliovirus inactivated type 2, Vero (MEF1) 
32 DagU 
poliovirus inactivated type 3, Vero (Saukett) 
1.5 mg 
aluminium phosphate (equivalent to 0.33 mg aluminium) 
0.6% v/v 
phenoxyethanol 

0.025 µg 
polymyxin B sulphate 

0.02 µg 
neomycin 

0.2 µg 
streptomycin 

0.005 mg 
formaldehyde 

0.02 mg 
glutaraldehyde 

0.01% 
polysorbate 80 
water for injections to 0.5 mL 
a
   The formulated content of 5LfU per 0.5 mL of tetanus
toxoid is the same as in the related 
product Tripacel
®
. 
The vaccine is prepared from: adsorbed purified and
formaldehyde detoxified diphtheria and 
tetanus toxins; adsorbed
purified and glutaraldehyde detoxified pertussis toxin (pertussis
toxoid or 
PT); adsorbed purified and
formaldehyde treated filamentous haemagglutinin (FHA); adsorbed 
purified pertactin (PRN) and 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 Product Information 

Page 2 of 14 
ADACEL
®
 POLIO is a diphtheria-tetanus-acellular pertussis combination
vaccine (dTpa) 
combined with