INFANRIX HEXA injection composite pack (pre-filled syringe and vial)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Hepatitis B surface antigen recombinant, Quantity: 20 microgram/mL; Tetanus toxoid, Quantity: 80 IU/mL; Pertussis filamentous haemagglutinin, Quantity: 50 microgram/mL; Pertussis toxoid, Quantity: 50 microgram/mL; Diphtheria toxoid, Quantity: 60 IU/mL; Pertactin, Quantity: 16 microgram/mL; Poliovirus, Quantity: 16 DAgU; Poliovirus, Quantity: 64 DAgU; Poliovirus, Quantity: 80 DAgU

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Diphtheria toxoid,Haemophilus influenza type B polyribose ribitol phosphate,Hepatitis B surface antigen recombinant,Pertactin,Pe

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: aluminium phosphate; sodium chloride; aluminium hydroxide hydrate; neomycin sulfate; polymyxin B sulfate; water for injections; 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 monodose vials and, with or without attached needle AUST L 19009, 1 syringe (0.5mL), 10 syringe (0.5mL), 1 monodose vial and

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

INFANRIX hexa is indicated for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b. INFANRIX hexa is also indicated for use as booster dose if boosting with hepatitis B, poliomyelitis, and Haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required. Refer to DOSAGE AND ADMINISTRATION for further information.

Product summary:

Visual Identification: Turbid liquid, white deposit, colourless supernatant; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2007-01-09

Patient Information leaflet

INFANRIX
HEXA
1
INFANRIX
HEXA
_Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B,
Inactivated Poliovirus and _
_Haemophilus influenzae type b Vaccine _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given INFANRIX
HEXA.
This leaflet answers some of the
common questions about INFANRIX
HEXA 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 HEXA
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD RECEIVING INFANRIX
HEXA TALK TO YOUR DOCTOR, NURSE
OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE.
You may need to read it again.
WHAT INFANRIX HEXA
IS USED FOR
INFANRIX HEXA is a vaccine used
to prevent six diseases: diphtheria,
tetanus, pertussis (whooping cough),
hepatitis B, poliomyelitis (polio) and
_Haemophilus influenzae_
type b (Hib).
The vaccine works by causing the
body to produce its own protection
(antibodies) against these diseases.
Diphtheria, tetanus, pertussis and Hib
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, f

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
INFANRIX HEXA (COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS
(DTPA), HEPATITIS B, POLIOVIRUS AND HAEMOPHILUS INFLUENZAE TYPE B
VACCINE) POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B,
Poliovirus and
Haemophilus influenzae type b vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 30 International units
Tetanus toxoid
1
not less than 40 International units
Bordetella pertussis antigens
Pertussis toxoid (PT)
1
25 micrograms
Filamentous Haemagglutinin (FHA)
1
25 micrograms
Pertactin (PRN)
1
8 micrograms
Hepatitis B surface antigen (HBs)
2,3
10 micrograms
Poliovirus (inactivated) (IPV)
type 1 (Mahoney strain)
4
40 D-antigen unit
type 2 (MEF-1 strain)
4
8 D-antigen unit
type 3 (Saukett strain)
4
32 D-antigen unit
Haemophilus influenzae type b polysaccharide
10 micrograms
(polyribosylribitol phosphate, PRP)
3
conjugated to tetanus toxoid as carrier protein
20 - 40 micrograms
1
adsorbed on aluminium hydroxide hydrate (Al(OH)
3
)
0.5 milligrams Al
3+
2
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA
technology
3
adsorbed on aluminium phosphate (AlPO
4
)
0.32 milligrams Al
3+
2
4
propagated in VERO cells
LIST OF EXCIPIENTS WITH KNOWN EFFECT
INFANRIX HEXA also contains residual amounts of neomycin sulfate and
polymyxin B
sulfate, which is carried over from the manufacturing process.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
The DTPa-HBV-IPV component is presented as a turbid white suspension.
Upon storage, a
white deposit and clear supernatant can be observed. This is a normal
observation.
The Hib component is presented as a white pellet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INFANRIX HEXA is indicated for primary immunisation of infants from
the age of 6 weeks
against diphtheria, tetanus, pertussis, hep