Dimethyl fumarate Accord

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970

Active ingredient:

dímetýl fúmarat

Available from:

Accord Healthcare S.L.U.

ATC code:

L04AX07

INN (International Name):

dimethyl fumarate

Therapeutic group:

Ónæmisbælandi lyf

Therapeutic area:

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Therapeutic indications:

Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Authorization status:

Leyfilegt

Authorization date:

2023-02-15

Patient Information leaflet

                                33
B. FYLGISEÐILL
34
FYLGISEÐILL: UPPLÝSINGAR FYRIR SJÚKLING
DIMETHYL FUMARATE ACCORD 120 MG MAGASÝRUÞOLIN HÖRÐ HYLKI
DIMETHYL FUMARATE ACCORD 240 MG MAGASÝRUÞOLIN HÖRÐ HYLKI
dímetýlfúmarat (dimethyl fumarate)
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ NOTA
LYFIÐ. Í HONUM ERU MIKILVÆGAR
UPPLÝSINGAR.
-
Geymið fylgiseðilinn. Nauðsynlegt getur verið að lesa hann
síðar.
-
Leitið til læknisins eða lyfjafræðings ef þörf er á frekari
upplýsingum.
-
Þessu lyfi hefur verið ávísað til persónulegra nota. Ekki má
gefa það öðrum. Það getur valdið
þeim skaða, jafnvel þótt um sömu sjúkdómseinkenni sé að
ræða.
-
Látið lækninn eða lyfjafræðing vita um allar aukaverkanir.
Þetta gildir einnig um aukaverkanir
sem ekki er minnst á í þessum fylgiseðli. Sjá kafla 4.
Í FYLGISEÐLINUM ERU EFTIRFARANDI KAFLAR:
1.
Upplýsingar um Dimethyl fumarate Accord og við hverju það er
notað
2.
Áður en byrjað er að nota Dimethyl fumarate Accord
3.
Hvernig nota á Dimethyl fumarate Accord
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á Dimethyl fumarate Accord
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM DIMETHYL FUMARATE ACCORD OG VIÐ HVERJU ÞAÐ ER
NOTAÐ
UPPLÝSINGAR UM DIMETHYL FUMARATE ACCORD
Dimethyl fumarate Accord er lyf sem inniheldur virka efnið
DÍMETÝLFÚMARAT
.
VIÐ HVERJU DIMETHYL FUMARATE ACCORD ER NOTAÐ
DIMETHYL FUMARATE ACCORD ER ÆTLAÐ TIL MEÐFERÐAR VIÐ MS-SJÚKDÓMI
(HEILA- OG MÆNUSIGGI) MEÐ
ENDURTEKNUM KÖSTUM HJÁ SJÚKLINGUM 13 ÁRA OG ELDRI.
MS-sjúkdómur er langvinnur sjúkdómur sem hefur áhrif á
miðtaugakerfið, þar á meðal heila og mænu.
MS-sjúkdómur með endurteknum köstum einkennist af endurteknum
einkennum frá taugakerfinu
(köstum). Einkennin eru mismunandi hjá hverjum og einum en á meðal
þeirra eru yfirleitt erfiðleikar
við göngu, tilfinning um jafnvægisleysi og sjónerfiðleikar (t.d.
þokusýn eða tvísýni). Þessi einkenni
geta horfið algjörlega að loknu kasti, en sum þei
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI LYFS
Dimethyl fumarate Accord 120 mg magasýruþolin hörð hylki
Dimethyl fumarate Accord 240 mg magasýruþolin hörð hylki
2.
INNIHALDSLÝSING
Dimethyl fumarate Accord 120 mg magasýruþolin hörð hylki
Hvert magasýruþolið hart hylki inniheldur 120 mg dímetýlfúmarat
(dimethyl fumarate)
Dimethyl fumarate Accord 240 mg magasýruþolin hörð hylki
Hvert magasýruþolið hart hylki inniheldur 240 mg dímetýlfúmarat
(dimethyl fumarate)
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Magasýruþolið hart hylki (magasýruþolið hylki)
Dimethyl fumarate Accord 120 mg magasýruþolin hörð hylki
Stærð „0“ (u.þ.b. 21,3 x 7,5 mm) hörð gelatínhylki með
grænni hettu og hvítum bol með svartri áletrun
„HR1“ á bolnum sem innihalda hvítar til beinhvítar,
kringlóttar, tvíkúptar, sýruhúðaðar smátöflur sem
eru sléttar báðum megin.
Dimethyl fumarate Accord 240 mg magasýruþolin hörð hylki
Stærð „0“ (u.þ.b. 21,3 x 7,5 mm) hörð gelatínhylki með
grænni hettu og bol með svartri áletrun „HR2“
á bolnum sem innihalda hvítar til beinhvítar, kringlóttar,
tvíkúptar, sýruhúðaðar smátöflur sem eru
sléttar báðum megin.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
Dimethyl fumarate Accord er ætlað til meðferðar við MS-sjúkdómi
með endurteknum köstum
(relapsing remitting multiple sclerosis, RRMS) hjá fullorðnum
sjúklingum og börnum 13 ára og eldri.
4.2
SKAMMTAR OG LYFJAGJÖF
Meðferð skal hafin undir eftirliti læknis sem hefur reynslu af
meðferð MS-sjúkdóms.
Skammtar
Upphafsskammtur er 120 mg tvisvar á dag. Eftir 7 daga skal auka
skammtinn að ráðlögðum
viðhaldsskammti, 240 mg tvisvar á dag (sjá kafla 4.4).
Ef sjúklingur gleymir að taka skammt á ekki að tvöfalda skammt.
Sjúklingurinn má eingöngu taka
skammtinn sem gleymdist ef hann lætur 4 klst. líða á milli
skammta. Að öðrum kosti þarf
sjúklingurinn að bíða fram að næsta áætlaða skammti.
Með þ
                                
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Active ingredient dímetýl fúmarat

dímetýl fúmarat

ATC code L04AX07

L04AX07

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) dimethyl fumarate

dimethyl fumarate

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