Quintanrix

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

Buy It Now

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:

Difteri toxoid, tetanus toxoid, inaktiveret, Bordetella pertussis, hepatitis B overflade antigen (rDNA), Haemophilus influenzae type b polysakkarid

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:

Vacciner

Therapeutic area:

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

Therapeutic indications:

Quintanrix er indiceret til primær immunisering af spædbørn (under det første år af livet) mod difteri, stivkrampe, kighoste, hepatitis B og invasiv sygdom forårsaget af Haemophilus influenzae type b og for booster immunisering af børn under den andet år af livet. Brug af Quintanrix bør fastsættes på grundlag af de officielle anbefalinger.

Product summary:

Revision: 2

Authorization status:

Trukket tilbage

Authorization date:

2005-02-17

Patient Information leaflet

                                Lægemidlet er ikke længere autoriseret til salg
32
B. INDLÆGSSEDDEL
Lægemidlet er ikke længere autoriseret til salg
33
INDLÆGSSEDDEL
LÆS HELE DENNE INDLÆGSSEDDEL OMHYGGELIGT FØR DIT BARN MODTAGER
VACCINEN.
-
Gem denne indlægsseddel indtil dit barn har fuldført hele
vaccinationsprogrammet. Du får
muligvis behov for at læse den igen.
-
Hvis du har yderligere spørgsmål, bedes du kontakte din læge eller
apoteket.
-
Denne vaccine er ordineret til dit barn og må ikke gives videre til
andre.
DENNE INDLÆGSSEDDEL FORTÆLLER
:
1.
Hvad er Quintanrix, og hvad det anvendes til
2.
Før dit barn modtager Quintanrix
3.
Hvordan Quintanrix gives
4.
Mulige bivirkninger
5.
Opbevaring af Quintanrix
6.
Yderligere oplysninger
QUINTANRIX, PULVER OG VÆSKE TIL SUSPENSION TIL INJEKTION
Difteri, stivkrampe, kighoste (hel celle), hepatitis B (rDNA) og
hæmofilus type b konjugeret vaccine
(adsorberet)
-
De aktive substanser i 1 dosis (0,5 ml) af Quintanrix er:
Difteri toxoid
1
mindst 30 International Units
Stivkrampe toxoid
1
mindst 60 International Units
Inaktiveret _Bordetella kighoste_
2
mindst 4International Units
Hepatitis B overflade antigen (rDNA)
2, 3
10 mikrogram
_Hæmofilus influenzae_ type b polysakkarid
(polyribosylribitolfosfat)
2
2.5 mikrogram
konjugeret til stivkrampe toxoid som bærestof
5-10 mikrogram
1
adsorberet til aluminiumhydroxidhydrat
Total: 0.26 milligram Al
3+
2
adsorberet til aluminiumfosfat
Total: 0.40 milligram Al
3+
3
Fremstillet i _Saccharomyces_ _cerevisae_ celler vha. rekombinant DNA
teknologi.
-
De andre indholdsstoffer i vaccinen er: laktose, thiomersal
(konserveringsmiddel),
natriumchlorid og vand til injektion.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN OG FREMSTILLER:
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
1.
HVAD QUINTANRIX ER OG HVAD DET ANVENDES TIL
Quintanrix er en hvid, lidt mælkeagtig, væske som fås ved at blande
hætteglasset indeholdende
difteri (D), tetanus (stivkrampe) (T), Pertussis (kighoste) (Pw) og
hepatitis B (HBV) væske (DTPw
HB
                                
                                Read the complete document

Summary of Product characteristics

                                Lægemidlet er ikke længere autoriseret til salg
1
BILAG I
PRODUKTRESUME
Lægemidlet er ikke længere autoriseret til salg
2
1.
LÆGEMIDLETS NAVN
Quintanrix, pulver og væske til suspension til injektion.
Difteri, stivkrampe, kighoste (hel celle), hepatitis B (rDNA) og
hæmofilus type b konjugeret vaccine
(adsorberet)
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Efter rekonstituering indeholder 1 dosis (0.5 ml):
Difteri toxoid
1
mindst 30 International Units
Stivkrampe toxoid
1
mindst 60 International Units
Inaktiveret _Bordetella kighoste_
2
mindst 4 International Units
Hepatitis B overflade antigen (rDNA)
2, 3
10 microgram
_Haemophilus influenzae_ type b polysakkarid
(polyribosylribitolfosfat)
2
2.5 microgram
konjugeret til stivkrampe toxoid som bærestof
5-10 microgram
1
adsorberet til aluminiumhydroxidhydrat
Total: 0.26 milligram Al
3+
2
adsorberet til aluminiumfosfat
Total: 0.40 milligram Al
3+
3
Fremstillet i _Saccharomyces_ _cerevisae_ celler vha. rekombinant DNA
teknologi.
Hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Pulver og væske til suspension til injektion
Den flydende difteri, stivkrampe, kighoste (hel celle), hepatitis B
(DTPw HBV) komponent er en uklar
hvid suspension. Den frysetørrede _Haemophilus influenzae_ type b
(HIB)komponent er et hvidt pulver.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
_ _
Quintanrix er indiceret til primær immunisering af spædbørn (under
første leveår) mod difteri,
stivkrampe, kighoste, hepatitis B og angribende sygdom forårsaget af
_Haemophilus influenzae_ type
b, og til booster immunisering af småbørn under 2. leveår.
Brug af Quintanrix bør besluttes på baggrund af officielle
anbefalinger.
4.2
DOSERING OG INDGIVELSESMÅDE
Dosering
_Primær vaccination: _
Det primære vaccinationsprogram består af tre doser af 0,5 ml som
skal administreres med
intervaller på mindst 4 uger, inden for de første 6 levemåneder i
overensstemmelse med lokale
officielle anbefalinger. Den første dosis kan administreres ved en
alder på 6 uger. Følgen
                                
                                Read the complete document

Similar products

Active ingredient Difteri toxoid, tetanus toxoid, inaktiveret, Bordetella pertussis, hepatitis B overflade antigen (rDNA), Haemophilus influenzae type b polysakkarid

Difteri toxoid, tetanus toxoid, inaktiveret, Bordetella pertussis, hepatitis B overflade antigen (rDNA), Haemophilus influenzae type b polysakkarid

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 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 English 10-09-2008
Summary of Product characteristics Summary of Product characteristics English 10-09-2008
Public Assessment Report Public Assessment Report English 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

Search alerts related to this product

Alerts Quintanrix Difteri toxoid, tetanus inaktiveret, diphtheria, tetanus, pertussis hepatitis

Quintanrix Difteri toxoid, tetanus inaktiveret, diphtheria, tetanus, pertussis hepatitis

View documents history

Documents history Documents history

Quintanrix