Infanrix-hexa

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diphtheria toxoid, adsorbed 30 [iU] (Not less than); Hepatitis B surface antigen, recombinant 10ug; Pertactin 8ug;  ; Pertussis filamentous haemagglutinin 25ug;  ; Pertussis toxoid, adsorbed 25ug;  ; Polio virus type 1 40 DAgU (/dose);  ; Polio virus type 2 8 DAgU (/dose);  ; Polio virus type 3 32 DAgU (/dose);  ; Tetanus toxoid, adsorbed 40 [iU] (Not less than); Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (Covalently bonded to tetanus toxoid 20 - 40micrograms);  

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Diphtheria toxoid, adsorbed 30 IU (Not less than)

Dosage:

0.5 mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Diphtheria toxoid, adsorbed 30 [iU] (Not less than) Hepatitis B surface antigen, recombinant 10ug Pertactin 8ug   Pertussis filamentous haemagglutinin 25ug   Pertussis toxoid, adsorbed 25ug   Polio virus type 1 40 DAgU (/dose)   Polio virus type 2 8 DAgU (/dose)   Polio virus type 3 32 DAgU (/dose)   Tetanus toxoid, adsorbed 40 [iU] (Not less than) Excipient: Aluminium Medium 199 Sodium chloride Water for injection Active: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (Covalently bonded to tetanus toxoid 20 - 40micrograms)   Excipient: Aluminium as aluminium phosphate Lactose

Units in package:

Syringe, glass, single dose, 0.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

GSK Vaccines GmbH

Therapeutic indications:

Infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b.

Product summary:

Package - Contents - Shelf Life: Combination pack, 1 x syringe + 1 x vial - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 10 x syringes + 10 x vials - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 1 x 0.5 mL - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1999-08-24

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
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
INFANRIX HEXA Combined diphtheria-tetanus-acellular pertussis,
hepatitis B, enhanced
inactivated polio vaccine and _Haemophilus influenzae_ type b powder
and suspension for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 mL) contains:
Diphtheria toxoid
1
not less than 30 International Units (IU)
Tetanus toxoid
1
not less than 40 International Units (IU)
_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, hydrated (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+
4
propagated in VERO cells
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
2
Powder and suspension for injection.
The DTPa-HBV-IPV component is presented as a turbid white suspension
in a syringe.
Upon storage, a white deposit and clear supernatant can be observed.
This is a normal
observation.
The Hib component is presented as a white powder in a glass vial.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INFANRIX HEXA is indicated for primary and booster vaccination of
infants and toddlers
against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and
_Haemophilus influenzae_
type b.
The use of INFANRIX HEXA should be in accordance with official
recommendations.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The primary vaccination schedule consists of two or three doses of 0.5
mL which sh