Quintanrix
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
10-09-2008
Valmisteyhteenveto
(SPC)
10-09-2008
Julkisesta arviointikertomuksesta
(PAR)
10-09-2008
Aktiivinen ainesosa:
Diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis, hepatitis B surface antigen (rDNA), Haemophilus influenzae type b polysaccharide
Saatavilla:
GlaxoSmithKline Biologicals S.A.
ATC-koodi:
J07CA10
INN (Kansainvälinen yleisnimi):
diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)
Terapeuttinen ryhmä:
Vaccines
Terapeuttinen alue:
Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Diphtheria
Käyttöaiheet:
Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.The use of Quintanrix should be determined on the basis of official recommendations.
Tuoteyhteenveto:
Revision: 2
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2005-02-17
Pakkausseloste
Medicinal Product no longer authorised
32
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
33
PACKAGE LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING
THIS MEDICINE.
-
Keep this leaflet until your child has finished the complete
vaccination course. You may need to
read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for your child and should not be
passed on to others.
IN THIS LEAFLET
:
1.
What Quintanrix is and what it is used for
2.
Before your child receives Quintanrix
3.
How Quintanrix is given
4.
Possible side effects
5.
Storing Quintanrix
6.
Further information
QUINTANRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and
Haemophilus_ _type b conjugate
vaccine (adsorbed)
-
The active substances contained in 1 dose (0.5 ml) of Quintanrix are:
Diphtheria toxoid
1
not less than 30 International Units
Tetanus toxoid
1
not less than 60 International Units
Inactivated _Bordetella pertussis_
2
not less than 4 International Units
Hepatitis B surface antigen (rDNA)
2, 3
10 micrograms
_Haemophilus influenzae_ type b polysaccharide
(polyribosylribitol phosphate)
2
2.5 micrograms
conjugated to tetanus toxoid as a carrier
5-10 micrograms
1
adsorbed on aluminium hydroxide, hydrated
Total: 0.26 milligrams Al
3+
2
adsorbed on aluminium phosphate
Total: 0.40 milligrams Al
3+
3
produced in _Saccharomyces_ _cerevisae_ cells by recombinant DNA
technology
-
The other ingredients in the vaccine are: lactose, thiomersal
(preservative), sodium chloride and
water for injections.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER:
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
1.
WHAT QUINTANRIX IS AND WHAT IT IS USED FOR
Quintanrix is a white slightly milky liquid obtained by mixing the
vial containing the diphtheria (D),
tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid
(DTPw-HBV) with the vial
containing
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Valmisteyhteenveto
Medicinal Product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Quintanrix powder and suspension for suspension for injection
Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and
Haemophilus_ _type b conjugate
vaccine (adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 30 International Units
Tetanus toxoid
1
not less than 60 International Units
Inactivated _Bordetella pertussis_
2
not less than 4 International Units
Hepatitis B surface antigen (rDNA)
2, 3
10 micrograms
_Haemophilus influenzae_ type b polysaccharide
(polyribosylribitol phosphate)
2
2.5 micrograms
conjugated to tetanus toxoid as a carrier
5-10 micrograms
1
adsorbed on aluminium hydroxide, hydrated
Total: 0.26 milligrams Al
3+
2
adsorbed on aluminium phosphate
Total: 0.40 milligrams Al
3+
3
produced in _Saccharomyces_ _cerevisae_ cells by recombinant DNA
technology
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection
The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B
(DTPw-HBV) component is a turbid
white suspension.
The lyophilised _Haemophilus influenzae_ type b (HIB) component is a
white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Quintanrix is indicated for primary immunisation of infants (during
the first year of life) against
diphtheria, tetanus, pertussis, hepatitis B and invasive disease
caused by _Haemophilus influenzae_
type b and for booster immunisation of young children during the
second year of life.
The use of Quintanrix should be determined on the basis of official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Primary vaccination: _
The primary vaccination schedule consists of three doses of 0.5 ml to
be administered at intervals of
at least 4 weeks within the first six months of life in accordance
with local official recommendatio
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