Dimethyl fumarate Neuraxpharm

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-12-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
22-12-2023
Public Assessment Report Public Assessment Report (PAR)
22-12-2023

Active ingredient:

dimetil fumarat

Available from:

Laboratorios Lesvi S.L.

ATC code:

L04AX07

INN (International Name):

dimethyl fumarate

Therapeutic group:

imunosupresivi

Therapeutic area:

Multipla Skleroza, Рецидивно-Ремиттирующее

Therapeutic indications:

Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Product summary:

Revision: 4

Authorization status:

odobren

Authorization date:

2022-05-13

Patient Information leaflet

                                31
B. UPUTA O LIJEKU
Lijek koji više nije odobren
32
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
DIMETILFUMARAT NEURAXPHARM 120 MG TVRDE ŽELUČANOOTPORNE KAPSULE
DIMETILFUMARAT NEURAXPHARM 240 MG TVRDE ŽELUČANOOTPORNE KAPSULE
dimetilfumarat
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika. To uključuje
i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Dimetilfumarat Neuraxpharm i za što se koristi
2.
Što morate znati prije nego počnete uzimati Dimetilfumarat
Neuraxpharm
3.
Kako uzimati Dimetilfumarat Neuraxpharm
4.
Moguće nuspojave
5.
Kako čuvati Dimetilfumarat Neuraxpharm
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE DIMETILFUMARAT NEURAXPHARM I ZA ŠTO SE KORISTI
ŠTO JE DIMETILFUMARAT NEURAXPHARM
Dimetilfumarat Neuraxpharm lijek je koji sadrži djelatnu tvar
DIMETILFUMARAT
.
ZA ŠTO SE KORISTI DIMETILFUMARAT NEURAXPHARM
DIMETILFUMARAT NEURAXPHARM KORISTI SE ZA LIJEČENJE
RELAPSNO-REMITIRAJUĆE MULTIPLE SKLEROZE
(MS) U BOLESNIKA U DOBI OD 13 I VIŠE GODINA.
MS je dugotrajno stanje koje utječe na središnji živčani sustav
(SŽS), uključujući mozak i leđnu
moždinu. Relapsno-remitirajuća MS je karakterizirana ponavljanim
napadima (relapsima) simptoma
živčanog sustava. Simptomi variraju od bolesnika do bolesnika, ali
obično uključuju teškoće pri
hodanju, poremećaje ravnoteže i probleme s vidom (npr. zamućen vid
ili dvoslike). Ovi simptomi
mogu u potpunosti nestati jednom kad je relaps prošao, ali neki
problemi mogu i ostati.
KAKO DJELUJE DIMETILFUMARAT NEURAXPHARM
Čini se da lijek Dimetilfumarat Neura
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
Dimetilfumarat Neuraxpharm 120 mg tvrde želučanootporne kapsule
Dimetilfumarat Neuraxpharm 240 mg tvrde želučanootporne kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Dimetilfumarat Neuraxpharm 120 mg:
Jedna kapsula sadrži 120 mg dimetilfumarata.
Dimetilfumarat Neuraxpharm 240 mg:
Jedna kapsula sadrži 240 mg dimetilfumarata.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda želučanootporna kapsula
Dimetilfumarat Neuraxpharm 120 mg: tvrde želatinozne kapsule, duljine
19 mm, s bijelim tijelom i sa
svjetlozelenom kapicom te otisnutom oznakom „120 mg” na tijelu.
Dimetilfumarat Neuraxpharm 240 mg: tvrde želatinozne kapsule, duljine
23 mm, svjetlozelene boje, s
otisnutom oznakom „240 mg” na tijelu.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Dimetilfumarat Neuraxpharm indiciran je za liječenje odraslih i
pedijatrijskih bolesnika u dobi od 13 i
više godina s relapsno-remitirajućom multiplom sklerozom (RRMS).
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje treba započeti pod nadzorom liječnika s iskustvom u
liječenju multiple skleroze.
Doziranje
Početna doza je 120 mg dvaput na dan. Nakon 7 dana, dozu je potrebno
povisiti na preporučenu dozu
održavanja od 240 mg dvaput na dan (vidjeti dio 4.4).
Ako bolesnik propusti dozu, ne smije uzeti dvostruku dozu. Bolesnik
smije uzeti propuštenu dozu
samo ako je između doza proteklo 4 sata. U suprotnom, bolesnik treba
pričekati vrijeme kada prema
rasporedu uzima sljedeću dozu.
Privremeno smanjenje doze na 120 mg dvaput na dan može smanjiti
pojavu navala crvenila i nuspojave
probavnog sustava. Unutar mjesec dana mora se nastaviti s
preporučenom dozom održavanja od 240 mg
dvaput na dan.
Lijek Dimetilfumarat Neuraxpharm treba uzeti s hranom (vidjeti dio
5.2). Uzimanje lijeka
Dimetilfumarat Neuraxpharm s hranom može poboljšati podnošljivost u
bolesnika koji imaju navale
crvenila ili nuspojave probavnog sustava (vidjeti dijelove 4.4, 
                                
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Similar products

Active ingredient dimetil fumarat

dimetil fumarat

ATC code L04AX07

L04AX07

Marketed by Laboratorios Lesvi S.L.

Laboratorios Lesvi S.L.

INN (International Name) dimethyl fumarate

dimethyl fumarate

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