INFANRIX-IPV 0.5mL injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tetanus toxoid, Quantity: 20 LfU/mL; Poliovirus, Quantity: 80 AgU/mL; Pertussis filamentous haemagglutinin, Quantity: 50 microgram/mL; Poliovirus, Quantity: 16 AgU/mL; Pertactin, Quantity: 16 microgram/mL; Poliovirus, Quantity: 64 AgU/mL; Pertussis toxoid, Quantity: 50 microgram/mL; Diphtheria toxoid, Quantity: 50 LfU/mL

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

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

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: aluminium hydroxide hydrate; water for injections; neomycin sulfate; polymyxin B sulfate; sodium chloride; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium

Administration route:

Intramuscular

Units in package:

10 x single dose pre-filled syringes with and without needle, 1 x single dose pre-filled syringe with and without needle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. INFANRIX-IPV is indicated for use in a three dose primary schedule for immunisation of infants from 6 weeks of age and over, against diphtheria, tetanus, pertussis and poliomyelitis. INFANRIX-IPV is also indicated as a single booster dose for children, up to and including 6 years of age, who have previously been immunised against diphthereia, tetanus, pertussis and polio.

Product summary:

Visual Identification: Turbid liquid, white deposit, colourless supernatant.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2009-04-30

Patient Information leaflet

INFANRIX-IPV
1
INFANRIX-IPV
_Combined Diphtheria -Tetanus-acellular Pertussis (DTPa) and
Inactivated Poliovirus Vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before your child is given
INFANRIX-IPV.
This leaflet answers some common
questions about INFANRIX-IPV. 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 risks of your child
having INFANRIX-IPV against the
benefits they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD RECEIVING THIS VACCINE,
ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE VACCINE.
You may need to read it again.
WHAT INFANRIX-IPV IS
USED FOR
INFANRIX-IPV is a vaccine used in
infants from 6 weeks of age and over
to prevent four diseases, diphtheria,
tetanus, pertussis (whooping cough)
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.
Poliomyelitis is an infectious disease
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. The spasms can be strong
enough to cause bone fractures of the
spine. The death

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
INFANRIX IPV (COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS
(DTPA) AND INACTIVATED POLIOVIRUS VACCINE) SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Combined diphtheria, tetanus, acellular pertussis (DTPa) and
inactivated poliovirus vaccine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Diphtheria toxoid
1
not less than 30 International units (25 Lf)
Tetanus toxoid
1
not less than 40 International units (10 Lf)
_Bordetella pertussis_ antigens
Pertussis toxoid (PT)
1
25 micrograms
Filamentous Haemagglutinin (FHA)
1
25 micrograms
Pertactin (PRN)
1
8 micrograms
Poliovirus (inactivated) (IPV)
type 1 (Mahoney strain)
2
40 D-antigen unit
type 2 (MEF-1 strain)
2
8 D-antigen unit
type 3 (Saukett strain)
2
32 D-antigen unit
1
adsorbed on aluminium hydroxide hydrate (Al(OH)
3
)
0.5 milligrams Al
3+
2
propagated in VERO cells
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
pertactin. The three
polioviruses are cultivated on a continuous VERO cell line, purified
and inactivated with
formaldehyde.
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.
2
INFANRIX IPV vaccine meets the World Health Organisation requirements
for manufacture
of biological substances, of diphtheria, tetanus, pertussis and
combined vaccines, and of
inactivated poliomyelitis vaccines
.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
INFANRIX IPV also contains residual amounts of neomycin sulfate and
polymyxin B sulfate,
which are carried o