Quintanrix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-09-2008
Summary of Product characteristics Summary of Product characteristics (SPC)
10-09-2008
Public Assessment Report Public Assessment Report (PAR)
10-09-2008

Active ingredient:

Diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis, hepatitis B surface antigen (rDNA), Haemophilus influenzae type b polysaccharide

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07CA10

INN (International Name):

diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)

Therapeutic group:

Vaccines

Therapeutic area:

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

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.

Product summary:

Revision: 2

Authorization status:

Withdrawn

Authorization date:

2005-02-17

Patient Information leaflet

                                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 
                                
                                Read the complete document

Summary of Product characteristics

                                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
                                
                                Read the complete document

Similar products

Active ingredient Diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis, hepatitis B surface antigen (rDNA), Haemophilus influenzae type b polysaccharide

Diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis, hepatitis B surface antigen (rDNA), Haemophilus influenzae type b polysaccharide

ATC code J07CA10

J07CA10

Marketed by GlaxoSmithKline Biologicals S.A.

GlaxoSmithKline Biologicals S.A.

INN (International Name) diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)

diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 10-09-2008
Summary of Product characteristics Summary of Product characteristics Bulgarian 10-09-2008
Public Assessment Report Public Assessment Report Bulgarian 10-09-2008
Patient Information leaflet Patient Information leaflet Spanish 10-09-2008
Summary of Product characteristics Summary of Product characteristics Spanish 10-09-2008
Public Assessment Report Public Assessment Report Spanish 10-09-2008
Patient Information leaflet Patient Information leaflet Czech 10-09-2008
Summary of Product characteristics Summary of Product characteristics Czech 10-09-2008
Public Assessment Report Public Assessment Report Czech 10-09-2008
Patient Information leaflet Patient Information leaflet Danish 10-09-2008
Summary of Product characteristics Summary of Product characteristics Danish 10-09-2008
Public Assessment Report Public Assessment Report Danish 10-09-2008
Patient Information leaflet Patient Information leaflet German 10-09-2008
Summary of Product characteristics Summary of Product characteristics German 10-09-2008
Public Assessment Report Public Assessment Report German 10-09-2008
Patient Information leaflet Patient Information leaflet Estonian 10-09-2008
Summary of Product characteristics Summary of Product characteristics Estonian 10-09-2008
Public Assessment Report Public Assessment Report Estonian 10-09-2008
Patient Information leaflet Patient Information leaflet Greek 10-09-2008
Summary of Product characteristics Summary of Product characteristics Greek 10-09-2008
Public Assessment Report Public Assessment Report Greek 10-09-2008
Patient Information leaflet Patient Information leaflet French 10-09-2008
Summary of Product characteristics Summary of Product characteristics French 10-09-2008
Public Assessment Report Public Assessment Report French 10-09-2008
Patient Information leaflet Patient Information leaflet Italian 10-09-2008
Summary of Product characteristics Summary of Product characteristics Italian 10-09-2008
Public Assessment Report Public Assessment Report Italian 10-09-2008
Patient Information leaflet Patient Information leaflet Latvian 10-09-2008
Summary of Product characteristics Summary of Product characteristics Latvian 10-09-2008
Public Assessment Report Public Assessment Report Latvian 10-09-2008
Patient Information leaflet Patient Information leaflet Lithuanian 10-09-2008
Summary of Product characteristics Summary of Product characteristics Lithuanian 10-09-2008
Public Assessment Report Public Assessment Report Lithuanian 10-09-2008
Patient Information leaflet Patient Information leaflet Hungarian 10-09-2008
Summary of Product characteristics Summary of Product characteristics Hungarian 10-09-2008
Public Assessment Report Public Assessment Report Hungarian 10-09-2008
Patient Information leaflet Patient Information leaflet Maltese 10-09-2008
Summary of Product characteristics Summary of Product characteristics Maltese 10-09-2008
Public Assessment Report Public Assessment Report Maltese 10-09-2008
Patient Information leaflet Patient Information leaflet Dutch 10-09-2008
Summary of Product characteristics Summary of Product characteristics Dutch 10-09-2008
Public Assessment Report Public Assessment Report Dutch 10-09-2008
Patient Information leaflet Patient Information leaflet Polish 10-09-2008
Summary of Product characteristics Summary of Product characteristics Polish 10-09-2008
Public Assessment Report Public Assessment Report Polish 10-09-2008
Patient Information leaflet Patient Information leaflet Portuguese 10-09-2008
Summary of Product characteristics Summary of Product characteristics Portuguese 10-09-2008
Public Assessment Report Public Assessment Report Portuguese 10-09-2008
Patient Information leaflet Patient Information leaflet Romanian 10-09-2008
Summary of Product characteristics Summary of Product characteristics Romanian 10-09-2008
Public Assessment Report Public Assessment Report Romanian 10-09-2008
Patient Information leaflet Patient Information leaflet Slovak 10-09-2008
Summary of Product characteristics Summary of Product characteristics Slovak 10-09-2008
Public Assessment Report Public Assessment Report Slovak 10-09-2008
Patient Information leaflet Patient Information leaflet Slovenian 10-09-2008
Summary of Product characteristics Summary of Product characteristics Slovenian 10-09-2008
Public Assessment Report Public Assessment Report Slovenian 10-09-2008
Patient Information leaflet Patient Information leaflet Finnish 10-09-2008
Summary of Product characteristics Summary of Product characteristics Finnish 10-09-2008
Public Assessment Report Public Assessment Report Finnish 10-09-2008
Patient Information leaflet Patient Information leaflet Swedish 10-09-2008
Summary of Product characteristics Summary of Product characteristics Swedish 10-09-2008
Public Assessment Report Public Assessment Report Swedish 10-09-2008

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Quintanrix