INFANRIX diphtheria toxoid / pertactin / pertussis filamentous haemagglutinin / pertussis toxoid / tetanus toxoid 0.5mL injectio

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Pertussis filamentous haemagglutinin, Quantity: 50 microgram/mL; Pertactin, Quantity: 16 microgram/mL; Pertussis toxoid, Quantity: 50 microgram/mL; Tetanus toxoid, Quantity: 20 LfU/mL; Diphtheria toxoid, Quantity: 50 LfU/mL

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis toxoid,Tetanus toxoid

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride

Administration route:

Intramuscular

Units in package:

0.5mL x 1, 0.5mL x 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. INDICATIONS AS OF 8TH JANUARY 1997 - Infanrix (DTPa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. Infanrix (DTPa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

Product summary:

Visual Identification: White turbid suspension; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-12-02

Patient Information leaflet

INFANRIX
®
1
INFANRIX
®
_Diphtheria-tetanus-acellular pertussis (DTPa) vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before your child is given
INFANRIX.
This leaflet answers some of the
common questions about INFANRIX
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 against the
expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD RECEIVING INFANRIX
TALK TO YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE.
You may need to read it again.
WHAT INFANRIX IS
USED FOR
INFANRIX is a vaccine used to
prevent three diseases, diphtheria,
tetanus, and pertussis (whooping
cough). The vaccine is sometimes
called DTPa vaccine.
Diphtheria, tetanus, and pertussis are
all serious life-threatening diseases
caused by bacterial infection. The
vaccine works by causing the body to
produce its own protection
(antibodies) against these diseases.
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. The spasms can be strong
enough to cause bone fractures of the
spine. The death rate is 30-40% of
cases.
PERTUSSIS (WHOOPING COUGH)
Pertussis is a highly infectious
illness. The disease affects the
breathing tra

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
INFANRIX (DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS (DTPA) VACCINE)
SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Diphtheria-tetanus-acellular pertussis (DTPa) vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
INFANRIX DTPa vaccine is a sterile suspension which contains
diphtheria toxoid, tetanus
toxoid and three purified antigens of _Bordetella pertussis
_[pertussis toxoid (PT), filamentous
haemagglutinin (FHA) and pertactin (PRN)] adsorbed onto aluminium
hydroxide hydrate.
The diphtheria and tetanus toxins are obtained from cultures of
_Corynebacterium diphtheriae_
and _Clostridium tetani_ and are then detoxified and purified. The
acellular pertussis vaccine
components (PT, FHA and PRN) are extracted from phase I _Bordetella
pertussis,_ and are
then purified and stabilised.
Each 0.5 mL dose of INFANRIX contains not less than 30 IU of
diphtheria toxoid, 40 IU of
tetanus toxoid, 25

g of PT, 25

g of FHA and 8

g of PRN.
The manufacture of this product includes exposure to bovine derived
materials. No
evidence exists that any case of vCJD (considered to be the human form
of bovine
spongiform encephalopathy) has resulted from the administration of any
vaccine product.
INFANRIX meets the World Health Organisation requirements for
biological substances and
for diphtheria and tetanus vaccines. No substances of human origin are
used in its
manufacture.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Suspension for injection.
Turbid white suspension. Upon storage a white deposit and clear
supernatant can be
observed.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INFANRIX (DTPa) is indicated for active primary immunisation against
diphtheria, tetanus
and pertussis when commenced between 2 months and 12 months of age.
INFANRIX (DTPa) is also indicated as fourth and fifth dose for
children from 15 months of
age up to and including 6 years of age who have been immunised
previously with three or
f