HEXAXIM DTPa-hepB-IPV-Hib Suspension for injection in pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

29-04-2021

Public Assessment Report (PAR)

22-11-2017

Active ingredient:

Tetanus protein, Quantity: 22 microgram; Haemophilus type B polysaccharide, Quantity: 12 microgram; Pertussis toxoid, Quantity: 25 microgram; Diphtheria toxoid, Quantity: 20 IU; Poliovirus, Quantity: 8 DAgU; Poliovirus, Quantity: 40 DAgU; Tetanus toxoid, Quantity: 40 IU; Pertussis filamentous haemagglutinin, Quantity: 25 microgram; Poliovirus, Quantity: 32 DAgU; hepatitis B surface antigen, Quantity: 10 microgram

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Diphtheria toxoid,hepatitis B surface antigen,Haemophilus type B polysaccharide,Pertussis filamentous haemagglutinin,Pertussis t

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: sucrose; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; water for injections; aluminium hydroxide hydrate; trometamol; tyrosine; arginine hydrochloride; histidine; isoleucine; leucine; lysine hydrochloride; phenylalanine; threonine; tryptophan; valine; cystine; methionine

Administration route:

Intramuscular

Units in package:

1 single dose pre-filled syringe with 1 or 2 separate needles, 10 single dose pre-filled syringes with 1 or 2 separate needles per each syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. Use of this vaccine should be in accordance with the national recommendation as per the current Immunisation Handbook.

Product summary:

Visual Identification: Hexaxim is a whitish, cloudy suspension.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 48 Months; 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:

2014-09-11

Patient Information leaflet

HEXAXIM
®
_DTPA-HEPB-IPV-HIB_
_Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), poliomyelitis (inactivated) and_
_Haemophilus influenzae type b conjugate vaccine (adsorbed)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOUR CHILD IS VACCINATED.
•
Keep this leaflet. You may need
to read it again.
•
If you have any further questions,
ask your doctor or pharmacist.
•
This vaccine has been prescribed
for your child. Do not pass it on
to others.
•
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
IN THIS LEAFLET:
•
What Hexaxim is and what it is
used for
•
Before your child is given
Hexaxim
•
How Hexaxim is given
•
Possible side effects
•
Storing Hexaxim
•
Further information
WHAT HEXAXIM IS AND
WHAT IT IS USED FOR
Hexaxim (DTPa-hepB-IPV-Hib) is a
vaccine used to protect against
infectious diseases.
Hexaxim helps to protect against
diphtheria, tetanus, pertussis,
hepatitis B, poliomyelitis and serious
diseases caused by Haemophilus
influenzae type b. Hexaxim can be
given to children from six weeks of
age.
The vaccine works by causing the
body to produce its own protection
(antibodies) against the bacteria and
viruses that cause these different
infections:
•
Diphtheria is an infectious
disease that usually first affects
the throat. In the throat, the
infection causes pain and
swelling which can lead to
suffocation. The bacteria that
cause the disease also make a
toxin (poison) that can damage
the heart, kidneys and nerves.
•
Tetanus (often called lock jaw) is
usually caused by the tetanus
bacteria entering a deep wound.
The bacteria make a toxin
(poison) that causes spasms of the
muscles, leading to inability to
breathe and the possibility of
suffocation.
•
Pertussis (often called whooping
cough) is a highly infectious
illness that affects the airways. It
causes severe coughing that may
lead to problems with breathing.
The cou

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Summary of Product characteristics

hexa-ccdsv7-piv4-21apr21
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
HEXAXIM (DTPA-HEPB-IPV-HIB) – SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Hexaxim
DTPa-hepB-IPV-Hib - Diphtheria, tetanus, pertussis (acellular,
component), hepatitis B
(rDNA), poliomyelitis (inactivated) and
_Haemophilus influenzae_
type b conjugate vaccine
(adsorbed).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hexaxim is a preservative free liquid formulation for intramuscular
administration which
combines: Diphtheria and Tetanus toxoids, Acellular Pertussis
(2-component), Recombinant
Hepatitis B surface antigen, Inactivated Poliomyelitis virus and
_Haemophilus influenzae_
type
b polysaccharide conjugated to tetanus protein.
Each 0.5 mL, adsorbed to aluminium hydroxide hydrate (0.6 mg,
expressed as Al3+), contains:
TABLE 1 - HEXAXIM COMPOSITION
ACTIVE SUBSTANCE
QUANTITY (PER 0.5 ML DOSE)
Diphtheria Toxoid
≥ 20 IU
1
Tetanus Toxoid
≥ 40 IU
2
Bordetella Pertussis
•
Pertussis Toxoid
•
Pertussis Filamentous Haemagglutinin
25 micrograms
25 micrograms
Hepatitis B surface antigen
3
10 micrograms
Poliovirus (Inactivated)4
Type 1 (Mahoney)
Type 2 (MEF-1)
Type 3 (Saukett)
40 D antigen
5
Units
6
8 D antigen
5
Units
6
32 D antigen
5
Units
6
_Haemophilus_ type B polysaccharide
conjugated to Tetanus protein
12 micrograms
22 – 36 micrograms
1
As lower confidence limit (p= 0.95) and not less than 30 I.U as mean
value
2
As lower confidence limit (p= 0.95)
3
Surface antigen of hepatitis B virus produced from recombinant strain
of the yeast _Hansenula polymorpha_
4
Produced on vero cells
5
Quantity of antigen in the final bulk product, according to WHO (TRS
910, 2002)
6
Or equivalent antigenic quantity determined by a suitable
immunochemical method
The vaccine may contain traces of glutaral, formaldehyde, neomycin,
streptomycin and
polymyxin B.
Contains phenylalanine. For the full list of excipients, see Section
6.1 List of excipients.
hexa-ccdsv7-piv4-21apr21
Page 2 of 14
3
PHARMACEUTICAL FORM
Hexaxim is a whitish, cloudy suspension for injection

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