Hexavac

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

purified diphtheria toxoid, Purified Tetanus Toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis B surface antigen, Inactivated Type 1 Poliovirus (Mahoney), inactivated type 2 poliovirus (MEF 1), Inactivated Type 3 Poliovirus (Saukett), Haemophilus influenzae type b polysaccharide

Saadav alates:

Sanofi Pasteur MSD, SNC

ATC kood:

J07CA

INN (Rahvusvaheline Nimetus):

diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted

Terapeutiline rühm:

Vaccines

Terapeutiline ala:

Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria

Näidustused:

This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2000-10-23

Infovoldik

38
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
B.
PACKAGE LEAFLET
Medicinal product no longer authorised
39
PACKAGE 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 further questions, please ask your doctor or your
pharmacist.
-
This vaccine has been prescribed for your child and you should not
pass it on to others.
In this leaflet
:
1.
What HEXAVAC is and what it is used for
2.
Before you use HEXAVAC
3.
How to use HEXAVAC
4.
Possible side effects
5.
Storing HEXAVAC
6.
Further information
HEXAVAC suspension for injection in pre-filled syringe
Diphtheria,
tetanus,
acellular
pertussis,
inactivated
poliomyelitis,
hepatitis
B
(recombinant)
and
_Haemophilus influenzae_ type b conjugate vaccine, adjuvanted.
The active substances are:
Purified diphtheria toxoid
....................................................... equal to or
greater than 20 IU* (30 Lf)
Purified tetanus
toxoid............................................................
equal to or greater than 40 IU* (10 Lf)
Purified pertussis toxoid
......................................................... 25
micrograms
Purified pertussis filamentous haemagglutinin ......................
25 micrograms
Hepatitis B surface antigen
**................................................ 5.0 micrograms
Inactivated type 1 poliovirus
(Mahoney)................................ D antigen^: 40 units
†
Inactivated type 2 poliovirus (MEF 1)
................................... D antigen^: 8 units
†
Inactivated type 3 poliovirus
(Saukett)................................... D antigen^: 32 units
†
_Haemophilus _
_influenzae_
type
b
polysaccharide
(polyribosylribitol
phosphate)
12 micrograms
conjugated to tetanus toxoid (24 micrograms)
for one adjuvanted dose of 0.5 ml
*
As lower confidence limit (p = 0.95).
**
Surface antigen of hepatitis B virus produced from recombinant strain
2150-2-3 of the yeast
_Saccharomyces cerevisiae_.
^
Quantity of antigen i

Toote omadused

_ _
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
HEXAVAC suspension for injection in pre-filled syringe
Diphtheria,
tetanus,
acellular
pertussis,
inactivated
poliomyelitis,
hepatitis
B
(recombinant)
and
_Haemophilus influenzae_ type b conjugate vaccine, adjuvanted.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml adjuvanted dose contains:
Active substances:
Purified diphtheria toxoid
....................................................... equal to or
greater than 20 IU* (30 Lf)
Purified tetanus
toxoid............................................................
equal to or greater than 40 IU* (10 Lf)
Purified pertussis toxoid
......................................................... 25
micrograms
Purified pertussis filamentous haemagglutinin ......................
25 micrograms
Hepatitis B surface antigen
**................................................ 5.0 micrograms
Inactivated type 1 poliovirus
(Mahoney)................................ D antigen^: 40 units
†
Inactivated type 2 poliovirus (MEF 1)
................................... D antigen^: 8 units
†
Inactivated type 3 poliovirus
(Saukett)................................... D antigen^: 32 units
†
_Haemophilus _
_influenzae_
type
b
polysaccharide
(polyribosylribitol
phosphate)
12 micrograms
conjugated to tetanus toxoid (24 micrograms)
Adjuvanted on aluminium hydroxide (0.3 mg)
*
As lower confidence limit (p = 0.95).
**
Surface antigen of hepatitis B virus produced from recombinant strain
2150-2-3 of the yeast
_Saccharomyces cerevisiae_.
^
Quantity of antigen in the final bulk product, according to W.H.O.
(TRS 673, 1992)
†
Or equivalent antigenic quantity determined by a suitable
immunochemical method
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe
HEXAVAC is a slightly opaque white suspension
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
This combined vaccine is indicated for primary and booster vaccination
of child