Tritanrix HepB

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
07-01-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
07-01-2014
Public Assessment Report Public Assessment Report (PAR)
07-01-2014

Active ingredient:

Diphtheria toxoid, hepatitis B surface antigen, Bordetella pertussis (inactivated), tetanus toxoid

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07CA05

INN (International Name):

diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)

Therapeutic group:

Vacciner

Therapeutic area:

Hepatitis B; Tetanus; Immunization; Whooping Cough; Diphtheria

Therapeutic indications:

Tritanrix HepB er indiceret til aktiv immunisering mod difteri, stivkrampe, pertussis og hepatitis B (HBV) hos spædbørn fra seks uger og fremefter (se afsnit 4.

Product summary:

Revision: 15

Authorization status:

Trukket tilbage

Authorization date:

1996-07-19

Patient Information leaflet

                                Lægemidlet er ikke længere autoriseret til salg
31
B. INDLÆGSSEDDEL
Lægemidlet er ikke længere autoriseret til salg
32
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
TRITANRIX HEPB INJEKTION, SUSPENSION
Difteria (D), tetanus (T), pertussis (helcelle) (Pw) og hepatitis B
(rDNA) (HBV) vaccine (adsorberet)
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DIT BARN MODTAGER VACCINEN.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
-
Lægen har ordineret Tritanrix HepB til dit barn personligt. Lad
derfor være med at give
Tritanrix HepB til andre.
-
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller
du bemærker bivirkninger,
som ikke er nævnt her.
OVERSIGT OVER INDLÆGSSEDLEN
:
1.
Tritanrix HepBs virkning og hvad du skal bruge det til
2.
Det skal du vide, før dit barn modtager Tritanrix HepB
3.
Sådan skal du tage Tritanrix HepB
4.
Bivirkninger
5.
Sådan opbevarer du Tritanrix HepB
6.
Yderligere oplysninger
1.
TRITANRIX HEPBS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
Tritanrix HepB er en vaccine, som anvendes til børn for at beskytte
mod fire sygdomme: difteri,
tetanus (stivkrampe), pertussis (kighoste) samt hepatitis B. Vaccinen
virker ved at hjælpe kroppen til
selv at producere egne beskyttelse (antistoffer) mod disse sygdomme.
•
DIFTERI:
Difteri angriber hovedsagelig luftvejene og nogle gange huden.
Generelt bliver luftvejene
betændte (opsvulmede), hvilket medfører vejrtrækningsbesvær og
nogle gange kvælning.
Bakterierne frigiver også et toksin (giftstof), som kan give
nerveskade, hjerteproblemer og endda
medføre døden.
•
STIVKRAMPE (TETANUS):
Stivkrampebakterier kommer ind i kroppen via snitsår, rifter eller
sår i
huden. Sår særligt udsat for infektion er brandsår, brud, dybe sår
eller sår forurenet med jord, støv,
hestemøg/gødning eller træflis. Bakterierne frigiver et toksin
(giftstof), som kan give
muskelstivhed, smertefulde muskelkramper, krampeanfald og endda
medføre døden.
Muskelkramperne kan
                                
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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
Tritanrix HepB, injektion, suspension,
Difteria (D), tetanus (T), pertussis (helcelle) (Pw) og hepatitis B
(rDNA) (HBV) vaccine (adsorberet)
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
1 dosis (0,5 ml) indeholder:
Difteritoxoid
1
ikke mindre end 30 IU
Tetanustoxoid
1
ikke mindre end 60 IU
_Bordetella pertussis_
(inaktiveret)
2
ikke mindre end 4 IU
Hepatitis B virus overflade antigen
2,3
10 mikrogram
1
Adsorberet til aluminiumhydroxid, hydreret
0,26 milligram Al
3+
2
Adsorberet til aluminiumphosphat
0,37 milligram Al
3+
3
Produceret på gærceller (
_Saccharomyces cerevisiae_
) ved rekombinant DNA-teknologi
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Injektion, suspension,
Uklar hvid suspension
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Tritanrix HepB er indiceret til aktiv immunisering mod difteri,
tetanus, pertussis og hepatitis B (HBV)
hos børn fra 6 uger og opefter
(
Se afsnit 4.2
).
4.2
DOSERING OG INDGIVELSESMÅDE
_Dosering _
Den anbefalede dosis er 0,5 ml.
Primær vaccination:
Det primære vaccinationsprogram består af tre doser indenfor de
første seks levemåneder. Hvor HBV
vaccine ikke gives ved fødslen, kan den kombinerede vaccine gives
allerede i 8 ugers alderen. Hvor
der er en høj endemisk forekomst af HBV, skal praksis med at
administrere HBV vaccinen ved fødsel
fortsættes. I disse tilfælde skal vaccination med den kombinerede
vaccine indledes i 6 ugers alderen.
Tre vaccinedoser skal administreres med intervaller på mindst 4 uger.
Når Tritanrix HepB gives som et 6-10-14-ugers program, anbefales det
at administrere en dosis HBV-
vaccine ved fødslen for at forbedre beskyttelsen.
I tilfælde af børn født af mødre, som er HBV bærere, skal de
immunoprofylaktiske forholdsregler for
hepatitis B ikke ændres. Dette kan indebære separat vaccination med
HBV og DTPw vacciner og kan
også omfatte indgift af HBIg ved fød
                                
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Similar products

Active ingredient Diphtheria toxoid, hepatitis B surface antigen, Bordetella pertussis (inactivated), tetanus toxoid

Diphtheria toxoid, hepatitis B surface antigen, Bordetella pertussis (inactivated), tetanus toxoid

ATC code J07CA05

J07CA05

Marketed by GlaxoSmithKline Biologicals S.A.

GlaxoSmithKline Biologicals S.A.

INN (International Name) diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)

diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)

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Patient Information leaflet Patient Information leaflet Bulgarian 07-01-2014
Summary of Product characteristics Summary of Product characteristics Bulgarian 07-01-2014
Public Assessment Report Public Assessment Report Bulgarian 07-01-2014
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