Fingolimod Mylan

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970
Public Assessment Report Public Assessment Report (PAR)
01-01-1970

Active ingredient:

fingolimod hydrochlorid

Available from:

Mylan Ireland Limited

ATC code:

L04AA27

INN (International Name):

fingolimod

Therapeutic group:

immunosuppressiva

Therapeutic area:

Multipel Sklerose, Recidiverende-Remitterende

Therapeutic indications:

Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 og 5. 1)orPatients med hurtigt udviklende alvorlige relapserende remitterende multipel sklerose, der er defineret ved 2 eller flere invaliderende tilbagefald i et år, og med 1 eller flere Gadolinium øge læsioner på hjernen MR-scanning eller en betydelig stigning i T2 læsion belastning i forhold til en tidligere de seneste MR -.

Authorization status:

autoriseret

Authorization date:

2021-08-18

Patient Information leaflet

                                50
B.
INDLÆGSSEDDEL
51
INDLÆGSSEDDEL: INFORMATION TIL PATIENTEN
FINGOLIMOD MYLAN 0,5 MG HÅRDE KAPSLER
fingolimod
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, 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 eller apotekspersonalet, 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 eller apotekspersonalet, hvis du får bivirkninger,
herunder bivirkninger, som
ikke er nævnt i denne indlægsseddel. Se punkt 4. Se den nyeste
indlægsseddel på
www.indlægsseddel.dk.
OVERSIGT OVER INDLÆGSSEDLEN:
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at tage Fingolimod Mylan
3.
Sådan skal du tage Fingolimod Mylan
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
HVAD ER FINGOLIMOD MYLAN
Fingolimod Mylan indeholder det aktive stof fingolimod.
HVAD ANVENDES FINGOLIMOD MYLAN TIL
Fingolimod Mylan anvendes til behandling af recidiverende-remitterende
multipel sklerose (MS) hos
voksne og børn og unge (10 år og derover), mere specifikt til:
•
Patienter, som ikke har haft virkning af anden MS-behandling.
eller
•
Patienter, som hurtigt har udviklet svær MS.
Fingolimod Mylan helbreder ikke MS, men det hjælper med at nedsætte
antallet af anfald og forsinker
udviklingen af fysisk invaliditet grundet MS.
HVAD ER MULTIPEL SKLEROSE
MS er en kronisk sygdom, der påvirker centralnervesystemet (CNS), som
udgøres af hjernen og
rygmarven. Ved MS ødelægger betændelse fedtskallen (kaldet myelin),
som ligger omkring nerverne i
CNS, og forhindrer derved nerverne i at fungere normalt. Det kaldes
demyelinisering.
Recidiverende-remitterende MS er kendetegnet ved gentagne attakker
(anfald) med symptomer fra
nervesystemet på grund af betændelse i CNS. Symptomerne varie
                                
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Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Fingolimod Mylan 0,5 mg hårde kapsler
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hver kapsel indeholder 0,5 mg fingolimod (som hydrochlorid).
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Hård kapsel (kapsel)
Brunorange uigennemsigtig overdel og hvid uigennemsigtig hoveddel med
påtrykt "MYLAN" over
"FD 0.5" med sort blæk på både overdel og hoveddel. Størrelse: ca.
16 mm lang.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Fingolimod Mylan er indiceret som sygdomsmodificerende behandling i
monoterapi ved meget aktiv
recidiverende-remitterende multipel sklerose hos følgende grupper af
voksne patienter og pædiatriske
patienter i alderen 10 år og ældre:
•
Patienter med højaktiv sygdom på trods af et fuldstændigt og
tilstrækkeligt behandlingsforløb
med mindst en sygdomsmodificerende behandling (for undtagelser og
information om
udvaskningsperioder, se pkt. 4.4 og 5.1).
eller
•
Patienter med svær hurtig-udviklende recidiverende-remitterende
multipel sklerose, defineret
ved 2 eller flere invaliderende attaker på ét år og med 1 eller
flere gadolinium-opladende
læsioner ved kraniel MR-scanning (magnetisk resonansscanning) eller
en signifikant stigning i
T2-læsionsbyrde i forhold til en tidligere nylig MR-scanning.
4.2
DOSERING OG ADMINISTRATION
Behandlingen bør indledes og gennemføres under opsyn af en læge med
erfaring i multipel sklerose.
Dosering
Hos voksne er den anbefalede dosis af fingolimod en 0,5 mg kapsel
taget oralt en gang dagligt.
Hos pædiatriske patienter (10 år eller derover) afhænger den
anbefalede dosis af kropsvægten:
Pædiatriske patienter med en kropsvægt ≤ 40 kg: en 0,25 mg kapsel
taget oralt en gang dagligt.
Pædiatriske patienter med en kropsvægt > 40 kg: en 0,5 mg kapsel
taget oralt en gang dagligt.
Pædiatriske patienter, som starter med 0,25 mg kapsler og
efterfølgende opnår en stabil kropsvægt på
over 40 kg, bør overgå til 0,5 mg kapsler.
Når der skiftes fra en daglig dosis på 
                                
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Similar products

Active ingredient fingolimod hydrochlorid

fingolimod hydrochlorid

ATC code L04AA27

L04AA27

Marketed by Mylan Ireland Limited

Mylan Ireland Limited

INN (International Name) fingolimod

fingolimod

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
Patient Information leaflet Patient Information leaflet Spanish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Spanish 01-01-1970
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
Summary of Product characteristics Summary of Product characteristics Czech 01-01-1970
Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet German 01-01-1970
Summary of Product characteristics Summary of Product characteristics German 01-01-1970
Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Estonian 01-01-1970
Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
Summary of Product characteristics Summary of Product characteristics Greek 01-01-1970
Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
Summary of Product characteristics Summary of Product characteristics English 01-01-1970
Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 01-01-1970
Summary of Product characteristics Summary of Product characteristics French 01-01-1970
Public Assessment Report Public Assessment Report French 01-01-1970
Patient Information leaflet Patient Information leaflet Italian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Italian 01-01-1970
Public Assessment Report Public Assessment Report Italian 01-01-1970
Patient Information leaflet Patient Information leaflet Latvian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Latvian 01-01-1970
Public Assessment Report Public Assessment Report Latvian 01-01-1970
Patient Information leaflet Patient Information leaflet Lithuanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-01-1970
Public Assessment Report Public Assessment Report Lithuanian 01-01-1970
Patient Information leaflet Patient Information leaflet Hungarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Hungarian 01-01-1970
Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Maltese 01-01-1970
Public Assessment Report Public Assessment Report Maltese 01-01-1970
Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
Summary of Product characteristics Summary of Product characteristics Dutch 01-01-1970
Public Assessment Report Public Assessment Report Dutch 01-01-1970
Patient Information leaflet Patient Information leaflet Polish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Polish 01-01-1970
Public Assessment Report Public Assessment Report Polish 01-01-1970
Patient Information leaflet Patient Information leaflet Portuguese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Portuguese 01-01-1970
Public Assessment Report Public Assessment Report Portuguese 01-01-1970
Patient Information leaflet Patient Information leaflet Romanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Romanian 01-01-1970
Public Assessment Report Public Assessment Report Romanian 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovak 01-01-1970
Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovenian 01-01-1970
Public Assessment Report Public Assessment Report Slovenian 01-01-1970
Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Finnish 01-01-1970
Public Assessment Report Public Assessment Report Finnish 01-01-1970
Patient Information leaflet Patient Information leaflet Swedish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Swedish 01-01-1970
Public Assessment Report Public Assessment Report Swedish 01-01-1970
Patient Information leaflet Patient Information leaflet Norwegian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Norwegian 01-01-1970
Patient Information leaflet Patient Information leaflet Icelandic 01-01-1970
Summary of Product characteristics Summary of Product characteristics Icelandic 01-01-1970
Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Croatian 01-01-1970
Public Assessment Report Public Assessment Report Croatian 01-01-1970

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