Fingolimod Mylan

Country: European Union

Language: Estonian

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 vesinikkloriid

Available from:

Mylan Ireland Limited

ATC code:

L04AA27

INN (International Name):

fingolimod

Therapeutic group:

Immunosupressandid

Therapeutic area:

Sclerosis Multiplex, Relapsing-Remitting

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 ja 5. 1)orPatients kiiresti arenev raske relapsing remitting sclerosis multiplex määratud 2 või enam puuet ägenemiste ühe aasta, ja on 1 või enam Gadoliinium suurendada kahjustused aju MRI või olulist kasvu, T2 kahjustus koormus võrreldes varasema hiljutise MRT.

Authorization status:

Volitatud

Authorization date:

2021-08-18

Patient Information leaflet

                                48
B. PAKENDI INFOLEHT
49
PAKENDI INFOLEHT: TEAVE PATSIENDILE
FINGOLIMOD MYLAN 0,5 MG KÕVAKAPSLID
fingolimood (
_fingolimodum_
)
ENNE RAVIMI VÕTMIST LUGEGE HOOLIKALT INFOLEHTE, SEST SIIN ON TEILE
VAJALIKKU TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Kui teil on lisaküsimusi, pidage nõu oma arsti või apteekriga.
-
Ravim on välja kirjutatud üksnes teile. Ärge andke seda kellelegi
teisele. Ravim võib olla neile
kahjulik, isegi kui haigusnähud on sarnased.
-
Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti
või apteekriga. Kõrvaltoime
võib olla ka selline, mida selles infolehes ei ole nimetatud. Vt
lõik 4.
INFOLEHE SISUKORD
1.
Mis ravim on Fingolimod Mylan ja milleks seda kasutatakse
2.
Mida on vaja teada enne Fingolimod Mylani võtmist
3.
Kuidas Fingolimod Mylanit võtta
4.
Võimalikud kõrvaltoimed
5.
Kuidas Fingolimod Mylanit säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON FINGOLIMOD MYLAN JA MILLEKS SEDA KASUTATAKSE
MIS ON FINGOLIMOD MYLAN
Fingolimod Mylani toimeaine on fingolimood.
MILLEKS FINGOLIMOD MYLANIT KASUTATAKSE
Fingolimod Mylanit kasutatakse ägenemiste ja remissioonidega
hulgiskleroosi (
_sclerosis multiplex,_
SM) raviks täiskasvanutel, lastel ja noorukitel (vanuses 10 aastat ja
vanemad), täpsemalt:

patsientidel, kelle ravi on vaatamata SM-i ravimite kasutamisele
ebaõnnestunud
või

patsientidel, kellel on kiiresti arenev raske SM.
Fingolimod Mylan ei ravi SM-i, kuid aitab vähendada haiguse
ägenemiste arvu ning aeglustada SM-i
põhjustatud füüsilise puude arenemist.
MIS ON HULGISKLEROOS (_SCLEROSIS MULTIPLEX, SM)_
SM on kestev seisund, mis mõjutab pea-ja seljaajust koosnevat
kesknärvisüsteemi (KNS). SM-i korral
hävitab põletik kesknärvisüsteemis närvide ümber paiknevat
kaitsekesta (seda nimetatakse müeliiniks)
ega lase närvidel õigesti toimida. Seda nimetatakse demüelinise
erumiseks.
Ägenemiste ja remissioonidega kulgevat SM-i iseloomustavad korduvad
närvisüsteemi sümptomite
atakid (haiguse ägenemine), mis 
                                
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Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
1.
RAVIMPREPARAADI NIMETUS
Fingolimod Mylan 0,5 mg kõvakapslid
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks kapsel sisaldab 0,5 mg fingolimoodi (
_fingolimodum_
) (vesinikkloriidina).
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Kõvakapsel (kapsel)
Pruunikasoranži läbipaistmatu kapslikaane ja valge läbipaistmatu
kapslikehaga kapsel, kapslikaanele
ja kapslikehale on musta tindiga trükitud ‘MYLAN’ ja selle all
‘FD 0.5’. Mõõt: pikkus ligikaudu
16 mm.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Fingolimod Mylan on näidustatud haigust modifitseeriva monoteraapiana
täiskasvanutele ja lastele
alates 10 aasta vanusest, kellel on väga aktiivne, ägenemiste (
_relapside_
) ja remissioonidega kulgev
hulgiskleroos
_(Sclerosis multiplex)_
:

patsientidel, kelle haigus on väga aktiivne vaatamata täielikule ja
adekvaatsele ravikuurile
vähemalt ühe haigust modifitseeriva ravimiga (erandid ja teave
väljauhtumisperioodide kohta vt
lõigud 4.4 ja 5.1).
või

patsientidel, kellel on kiiresti progresseeruv hulgiskleroos, mille
puhul on kaks või enam puuet
süvendavat ägenemist aasta jooksul ja üks või enam gadoliiniumiga
kontrasteeruvat kollet aju
magnetresonantstomograafias (MRT) või märkimisväärne T2-kollete
arvu suurenemine
võrreldes viimase MRT-uuringuga.
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Ravi peab alustama ja selle kulgu pidevalt jälgima
_sclerosis multiplex’_
i ravis kogenud arst.
Annustamine
_ _
Soovitatav fingolimoodi annus täiskasvanutele on üks 0,5 mg kapsel
ööpäevas, manustatuna
suukaudselt.
Soovitatav annus lastele (10-aastased ja vanemad) sõltub kehakaalust:
-
Lapsed kehakaaluga ≤ 40 kg: üks 0,25 mg kapsel ööpäevas,
manustatuna suukaudselt.
-
Lapsed kehakaaluga > 40 kg: üks 0,5 mg kapsel ööpäevas,
manustatuna suukaudselt.
Lapsed, kes alustavad annustamist 0,25 mg kapslitega ja hiljem
saavutavad püsiva kehakaalu üle
40 kg, peavad üle minema 0,5 mg kapslite peale.
3
Üleminekul 0,25 mg annuselt 0,5 mg annusele, on s
                                
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Active ingredient fingolimod vesinikkloriid

fingolimod vesinikkloriid

ATC code L04AA27

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Marketed by Mylan Ireland Limited

Mylan Ireland Limited

INN (International Name) fingolimod

fingolimod

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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
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Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
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Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 01-01-1970
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Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
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Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
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Public Assessment Report Public Assessment Report English 01-01-1970
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