Fluenz

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-12-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
03-12-2014
Public Assessment Report Public Assessment Report (PAR)
03-12-2014

Active ingredient:

Reassortant influenza-virus (levende, svækkede) af følgende stammer:A/California/7/2009 (H1N1)pdm09 lignende stamme, A/Victoria/361/2011 (H3N2) som stamme, B/Massachusetts/2/2012 lignende stamme

Available from:

MedImmune LLC

ATC code:

J07BB03

INN (International Name):

influenza vaccine (live attenuated, nasal)

Therapeutic group:

Vacciner

Therapeutic area:

Influenza, Human; Immunization

Therapeutic indications:

Prophylax af influenza hos individer 24 måneder til under 18 år. Brug af Fluenz bør være baseret på officielle anbefalinger.

Product summary:

Revision: 4

Authorization status:

Trukket tilbage

Authorization date:

2011-01-27

Patient Information leaflet

                                21
B. INDLÆGSSEDDEL
Lægemidlet er ikke længere autoriseret til salg
22
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
FLUENZ NÆSESPRAY, SUSPENSION
Influenzavaccine (levende svækket, nasal)
Dette lægemiddel er underlagt supplerende overvågning. Dermed kan
der hurtigt tilvejebringes nye
oplysninger om sikkerheden. Du kan hjælpe ved at indberette alle de
bivirkninger, du får. Se sidst i
punkt 4, hvordan du indberetter bivirkninger.
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN VACCINEN GIVES, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER
TIL DIG ELLER DIT BARN.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen, sundhedspersonalet eller på apoteketspersonalet, hvis
der er mere, du vil vide.
-
Lægen har ordineret denne vaccine til dig eller dit barn personligt.
Lad derfor være med at
give den til andre.
-
Tal med lægen, sundhedspersonalet eller apotekspersonalet, hvis en
bivirkning bliver værre,
eller du får bivirkninger, som ikke er nævnt her. Se punkt 4.
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du får Fluenz
3.
Sådan gives Fluenz
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Fluenz er en vaccine til at forebygge influenza. Den anvendes hos
børn og unge i alderen 24 måneder
op til 18 år.
Når en person får vaccinen, vil immunsystemet (kroppens naturlige
forsvarssystem) producere dets
egen beskyttelse mod influenzavirus. Ingen af indholdsstofferne i
vaccinen kan forårsage influenza.
Fluenz-vaccinens virus er dyrket i hønseæg. Vaccinen er rettet mod
tre stammer af influenzavirus
hvert år, efter de årlige anbefalinger fra
Verdenssundhedsorganisationen (World Health
Organisation, WHO).
2.
DET SKAL DU VIDE, FØR DU FÅR FLUENZ
DU VIL IKKE FÅ FLUENZ

HVIS DU ER ALLERGISK
over for æg, æggeprotein, gentamicin eller gelatine eller et af de
øvrige
indholdsstoffer (angivet i punkt 6 ”Pakningsstørrelser og
yderligere oplysninger”). Ved tegn
på overfølsomhedsreaktioner, se punkt 4 
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
Lægemidlet er ikke længere autoriseret til salg
2
Dette lægemiddel er underlagt supplerende overvågning. Dermed kan
nye sikkerhedsoplysninger
hurtigt tilvejebringes. Læger og sundhedspersonale anmodes om at
indberette alle mistænkte
bivirkninger. Se i pkt. 4.8, hvordan bivirkninger indberettes.
1.
LÆGEMIDLETS NAVN
FLUENZ næsespray, suspension
Influenzavaccine (levende svækket, nasal)
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Reassortant influenzavirus* (levende svækket) fra følgende
stammer**:
A/California/7/2009 (H1N1)pdm09-lignende stamme
(A/California/7/2009, MEDI 228029)
10
7,0±0,5
FFU***
A/Victoria/361/2011 (H3N2)-lignende stamme
(A/Texas/50/2012, MEDI 237514)
10
7,0±0,5
FFU***
B/Massachusetts/2/2012-lignende stamme
(B/Massachusetts/2/2012, MEDI 237751)
10
7,0±0,5
FFU***
.......................................................................................................pr.
0,2 ml dosis
*
formeret i befrugtede hønseæg fra sunde hønsehold.
**
produceret i VERO-celler ved revers genteknologi. Dette produkt
indeholder genetisk
modificerede organismer (GMO’er).
***
fluorescent focus units (FFU)
Denne vaccine følger WHO’s anbefalinger (nordlige halvkugle) og
EU’s beslutning for
sæson 2013/2014.
Denne vaccine kan indeholde rester af følgende stoffer: æggeprotein
(f.eks. ovalbumin) og gentamicin.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Næsespray, suspension
Suspensionen er farveløs til svag gullig, klar til opaliserende. Der
kan være små hvide partikler
til stede.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Influenzaprofylakse hos personer i alderen 24 måneder op til 18 år.
Brugen af FLUENZ bør være baseret på officielle anbefalinger.
Lægemidlet er ikke længere autoriseret til salg
3
4.2
DOSERING OG ADMINISTRATION
Dosering
_Børn og unge fra 24 måneder: _
0,2 ml (administreret som 0,1 ml pr. næsebor).
Børn, som ikke tidligere er blevet vaccineret mod sæsonbestemt
influenza, bør have en 2. dosis
efter mindst 4
                                
                                Read the complete document

Similar products

Active ingredient Reassortant influenza-virus (levende, svækkede) af følgende stammer:A/California/7/2009 (H1N1)pdm09 lignende stamme, A/Victoria/361/2011 (H3N2) som stamme, B/Massachusetts/2/2012 lignende stamme

Reassortant influenza-virus (levende, svækkede) af følgende stammer:A/California/7/2009 (H1N1)pdm09 lignende stamme, A/Victoria/361/2011 (H3N2) som stamme, B/Massachusetts/2/2012 lignende stamme

ATC code J07BB03

J07BB03

Marketed by MedImmune LLC

MedImmune LLC

INN (International Name) influenza vaccine (live attenuated, nasal)

influenza vaccine (live attenuated, nasal)

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Patient Information leaflet Patient Information leaflet Bulgarian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-12-2014
Public Assessment Report Public Assessment Report Bulgarian 03-12-2014
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Summary of Product characteristics Summary of Product characteristics Spanish 03-12-2014
Public Assessment Report Public Assessment Report Spanish 03-12-2014
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Fluenz