Lusduna

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-01-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
22-01-2019
Public Assessment Report Public Assessment Report (PAR)
22-01-2019

Active ingredient:

insulin glargin

Available from:

Merck Sharp & Dohme B.V.

ATC code:

A10AE04

INN (International Name):

insulin glargine

Therapeutic group:

Narkotika anvendt i diabetes

Therapeutic area:

Diabetes Mellitus

Therapeutic indications:

Behandling af diabetes mellitus hos voksne, unge og børn i alderen 2 år og derover.

Product summary:

Revision: 2

Authorization status:

Trukket tilbage

Authorization date:

2017-01-03

Patient Information leaflet

                                28
B. INDLÆGSSEDDEL
Lægemidlet er ikke længere autoriseret
29
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
LUSDUNA 100 ENHEDER/ML INJEKTIONSVÆSKE, OPLØSNING, I FYLDT PEN
insulin glargin
Dette lægemiddel er underlagt supplerende overvågning. Dermed kan
der hurtigt tilvejebringes nye
sikkerhedsoplysninger. Du kan hjælpe ved at indberette alle de
bivirkninger, du får. Se sidst i punkt 4,
hvordan du indberetter bivirkninger.
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, HERUNDER BRUGSANVISNINGEN TIL
LUSDUNA NEXVUE FYLDT PEN,
INDEN DU BEGYNDER AT TAGE DETTE LÆGEMIDDEL, DA DEN INDEHOLDER VIGTIGE
OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er
mere, du vil vide.
-
Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor
være med at give medicinen
til andre. Det kan være skadeligt for andre, selvom de har de samme
symptomer, som du har.
-
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du
får bivirkninger, herunder
bivirkninger, som ikke er nævnt her. Se punkt 4.
Se den nyeste indlægsseddel på www.indlaegsseddel.dk
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at tage Lusduna.
3.
Sådan skal du tage Lusduna.
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
Lusduna indeholder insulin glargin. Dette er et modificeret insulin,
der ligner humant insulin meget.
Lusduna anvendes til at behandle sukkersyge (diabetes mellitus) hos
voksne, unge og børn fra 2 år og
opefter.
Diabetes mellitus er en sygdom, som skyldes, at kroppen ikke danner
tilstrækkeligt insulin til at holde
blodets sukkerindhold under kontrol. Insulin glargin er
langtidsvirkende og har en jævn
blodsukkersænkende effekt.
2.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE LUSDUNA
TAG IKKE LUSDUNA
-
hvis du er allergisk over for insulin glargin eller et af de øvrige
indholdsstoffer i Lusduna
(angivet i punkt 6).
Lusduna er kun egnet t
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
Lægemidlet er ikke længere autoriseret
2
Dette lægemiddel er underlagt supplerende overvågning. Dermed kan
nye sikkerhedsoplysninger
hurtigt tilvejebringes. Læger og sundhedspersonale anmodes om at
indberette alle formodede
bivirkninger. Se i pkt. 4.8, hvordan bivirkninger indberettes.
1.
LÆGEMIDLETS NAVN
LUSDUNA 100 enheder/ml injektionsvæske, opløsning, i fyldt pen
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hver ml indeholder 100 enheder insulin glargin* (svarende til 3,64
mg).
Hver pen indeholder 3 ml injektionsvæske, opløsning, svarende til
300 enheder.
*Insulin glargin er fremstillet ved rekombinant DNA-teknologi i
_Escherichia coli_.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Injektionsvæske, opløsning (injektion). Nexvue.
Klar farveløs opløsning.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Behandling af diabetes mellitus hos voksne, unge og børn fra 2 år og
opefter.
4.2
DOSERING OG ADMINISTRATION
Dosering
LUSDUNA indeholder insulin glargin, en insulin-analog. Den har en lang
virkningsvarighed.
LUSDUNA skal doseres en gang dagligt. Det kan gives på et hvilket som
helst tidspunkt af dagen,
men på samme tid hver dag.
Dosering og tidspunkt for dosering skal tilpasses individuelt. Til
patienter med type 2-diabetes
mellitus kan LUSDUNA også indgives sammen med orale antidiabetika.
Styrken af dette præparat er angivet i enheder. Disse enheder gælder
udelukkende for insulin glargin
og er ikke det samme som IE eller de enheder, der bruges til at angive
styrken på andre
insulinanaloger (se pkt. 5.1).
Særlige populationer
_Ældre (≥ 65 år)_
Hos ældre kan en fremadskridende forringelse af nyrefunktionen føre
til et stadigt fald i
insulinbehovet.
_Nedsat nyrefunktion_
Hos patienter med nedsat nyrefunktion kan insulinbehovet være
reduceret på grund af nedsat
insulinmetabolisme.
Lægemidlet er ikke længere autoriseret
3
_Nedsat leverfunktion_
Hos patienter med nedsat leverfunktion kan insulinbehovet mindskes på
grund af nedsat evne
                                
                                Read the complete document

Similar products

Active ingredient insulin glargin

insulin glargin

ATC code A10AE04

A10AE04

Marketed by Merck Sharp & Dohme B.V.

Merck Sharp & Dohme B.V.

INN (International Name) insulin glargine

insulin glargine

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Patient Information leaflet Patient Information leaflet Bulgarian 22-01-2019
Summary of Product characteristics Summary of Product characteristics Bulgarian 22-01-2019
Public Assessment Report Public Assessment Report Bulgarian 22-01-2019
Patient Information leaflet Patient Information leaflet Spanish 22-01-2019
Summary of Product characteristics Summary of Product characteristics Spanish 22-01-2019
Public Assessment Report Public Assessment Report Spanish 22-01-2019
Patient Information leaflet Patient Information leaflet Czech 22-01-2019
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Public Assessment Report Public Assessment Report Czech 22-01-2019
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Public Assessment Report Public Assessment Report German 22-01-2019
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