Hexaxim

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Diphtheria toxoid, adsorbed 30 Lf U equivalent to not less than 20 IU; Haemophilus influenzae type b polysaccharide 12ug ((polyribosylribitol phosphate) conjugated to tetanus protein (22-36 mcg)); Hepatitis B virus surface antigen 10ug; Pertussis filamentous haemagglutinin 25ug (adsorbed); Pertussis toxoid, adsorbed 25ug; Polio virus type 1 40 DAgU (Mahoney); Polio virus type 2 8 DAgU (MEF-1); Polio virus type 3 32 DAgU (Saukett); Tetanus toxoid, adsorbed 10 Lf U equivalent to not less than 40 IU

זמין מ:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (שם בינלאומי):

Diphtheria toxoid, adsorbed 30 Lf U (equivalent to not less than 20 IU)

טופס פרצבטיות:

Suspension for injection

הרכב:

Active: Diphtheria toxoid, adsorbed 30 Lf U equivalent to not less than 20 IU Haemophilus influenzae type b polysaccharide 12ug ((polyribosylribitol phosphate) conjugated to tetanus protein (22-36 mcg)) Hepatitis B virus surface antigen 10ug Pertussis filamentous haemagglutinin 25ug (adsorbed) Pertussis toxoid, adsorbed 25ug Polio virus type 1 40 DAgU (Mahoney) Polio virus type 2 8 DAgU (MEF-1) Polio virus type 3 32 DAgU (Saukett) Tetanus toxoid, adsorbed 10 Lf U equivalent to not less than 40 IU Excipient: Aluminium hydroxide Amino acids Dibasic sodium phosphate Monobasic potassium phosphate Sucrose Trometamol Water for injection

סוג מרשם:

Prescription

תוצרת:

Sanofi Pasteur SA

סממני תרפויטית:

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.

leaflet_short:

Package - Contents - Shelf Life: Syringe, glass, tip cap closure. Two needles provided separately. - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. One needle provided separately. - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. Twenty needles provided separately. - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. Ten needles provided separately. - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration.

תאריך אישור:

2013-07-24

עלון מידע

HEXAXIM
®
1
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 br

מאפייני מוצר

hexa-ccdsv8-ccdsv10-dsv7-15feb23
Page 1
NEW ZEALAND DATA SHEET
1
HEXAXIM (SUSPENSION FOR INJECTION)
Hexaxim 0.5 mL, suspension for injection
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 Al
3+
), 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 microgram
25 microgram
Hepatitis B surface antigen
3
10 microgram
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 influenzae_ type B polysaccharide conjugated to Tetanus
protein
12 microgram
22 – 36 microgram
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 Or equivalent activity determined by an immunogenicity evaluation
4 Surface antigen of hepatitis B virus produced from recombinant
strain of the yeast Hansenula polymorpha
5 Produced on vero cells
6 Quantity of antigen in the final bulk product, according to WHO (TRS
673, 1992)
7 Or equivalent antigenic quantity determined by a suitable
immunochemical method
hexa-ccdsv8-ccdsv10-dsv7-15feb23
Page 2
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.
3
PHARMACEUTICAL FORM
4
HEXAXIM IS A WHITISH CLOUDY SUSPEN