Infanrix Penta

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

Poliovirus; Pertactin; Pertussis filamentous haemagglutinin; Pertussis toxoid; Diphtheria toxoid; Hepatitis B surface antigen recombinant; Tetanus toxoid

थमां उपलब्ध:

GlaxoSmithKline Australia Pty Ltd

वर्ग:

Medicine Registered

सूचना पत्रक

INFANRIX(R) PENTA
1
INFANRIX(R) PENTA 
_Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B
and Inactivated Poliovirus Vaccine_
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about INFANRIX
PENTA  vaccine.  It does not contain
all the available information.  It does
not take the place of talking to your
doctor, nurse or pharmacist. 
All medicines and vaccines have
risks and benefits.  Your doctor has
weighed the possible risks of your
child having INFANRIX PENTA
against the expected benefits. 
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD RECEIVING INFANRIX
PENTA TALK TO YOUR DOCTOR, NURSE
OR PHARMACIST. 
KEEP THIS LEAFLET WITH THIS VACCINE.
You may need to read it again
WHAT INFANRIX
PENTA IS USED FOR
INFANRIX PENTA is a vaccine
used to prevent five diseases,
diphtheria, tetanus, pertussis
(whooping cough), hepatitis B and
poliomyelitis (polio).  The vaccine
works by causing the body to
produce its own protection
(antibodies) against these diseases. 
Diphtheria, tetanus, and pertussis are
all serious life-threatening diseases
caused by bacterial infection.
Hepatitis B and poliomyelitis are
infectious diseases caused by viral
infection. 
DIPHTHERIA
Diphtheria mainly affects the airways
and sometimes the skin.  Generally
the airways become inflamed
(swollen) causing severe breathing
difficulties and sometimes
suffocation.  The bacteria also release
a toxin (poison), which can cause
nerve damage, heart problems, and
death. The risk of serious
complications and death is greater in
the very young and elderly. 
TETANUS (LOCKJAW) 
Tetanus bacteria enter the body
through wounded skin.  Wounds that
are especially prone to infection are
burns, fractures, deep wounds or
wounds contaminated with soil, dust,
horse manure or wood splinters.  The
bacteria release a toxin (poison),
which can cause muscle stiffness,
painful muscle spasms, fits and
death. �

उत्पाद विशेषताएं

INFANRIX PENTA PRODUCT INFORMATION

Issue 7   

1

INFANRIX
®
 PENTA
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B
and Inactivated 
Poliovirus Vaccine 

DESCRIPTION 

INFANRIX
®
 PENTA vaccine is a sterile suspension which contains diphtheria
toxoid, tetanus 
toxoid, three purified antigens of _Bordetella pertussis _[pertussis
toxoid (PT), pertussis filamentous 
haemagglutinin (FHA) and pertactin (PRN)] and the purified major
surface antigen (HBsAg) of the 
hepatitis B virus (HBV), adsorbed on aluminium salts. It also contains
three types of inactivated 
polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3:
Saukett strain). 

The diphtheria and tetanus toxoids are obtained by formaldehyde
treatment of purified  
_Corynebacterium diphtheriae_ and _Clostridium tetani_ toxins.
 The acellular pertussis vaccine 
components are obtained by extraction and purification from phase
I _Bordetella pertussis _cultures_,_ 
followed by irreversible detoxification of the pertussis toxin by
glutaraldehyde and formaldehyde 
treatment, and formaldehyde treatment of FHA and PRN.
The diphtheria toxoid, tetanus toxoid and 
acellular pertussis components are adsorbed onto aluminium salts.  

The surface antigen of the HBV (HBsAg) is produced by culture of
genetically-engineered 
_Saccharomyces cerevisiae _yeast cells which carry the gene coding
for the major surface antigen of 
the HBV.  This HBsAg expressed in yeast cells is purified by several
physico-chemical steps. 

The three polioviruses are cultivated on a continuous VERO cell line,
purified and inactivated with 
formaldehyde. 

A 0.5 mL dose of vaccine contains 30IU (25 Lf U) of diphtheria
toxoid, 40IU (10 Lf U) of tetanus 
toxoid,  25µg of adsorbed PT, 25µg of adsorbed pertussis FHA, 8µg
of adsorbed PRN, 10µg of 
adsorbed recombinant HBsAg protein, 40 D-antigen units of type 1
(Mahoney), 8 D-a