natgillin/translations-raw huggingface dataset:
Cases of Fanconi syndrome have been reported for a medicinal product containing dimethyl fumarate in combination with other fumaric acid esters. 
O primerih Fanconijevega sindroma so poročali v povezavi s kombinacijo zdravila, ki vsebuje dimetilfumarat in druge estre fumarne kisline.
Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients. 
Dimetilfumarata niso preučili pri bolnikih z obstoječim nizkim številom limfocitov, zato je potrebna pri zdravljenju teh bolnikov previdnost.
In humans, dimethyl fumarate is extensively metabolised by esterases before it reaches the systemic circulation and further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system. 
Pri ljudeh dimetilfumarat izčrpno presnovijo esteraze, preden doseže sistemski obtok in se nadalje presnovi v ciklu trikarboksilne kisline, pri katerem ne sodeluje sistem citokroma P450 (CYP).
Dimethyl fumarate and monomethyl fumarate, the primary metabolite of dimethyl fumarate, significantly reduced immune cell activation and subsequent release of proinflammatory cytokines in response to inflammatory stimuli in preclinical models. 
V predkliničnih modelih dimetilfumarat in monometil fumarat, glavni presnovek dimetilfumarata, močno zmanjšujeta imunsko aktivacijo celice in posledično sproščanje provnetnih citokinov v odgovor na vnetno draženje.
The relevance of these findings to human risk is unknown. 
Pomen teh ugotovitev za človeka ni znan.
Potential drug interaction risks were not identified from in vitro CYP-inhibition and induction studies, a p-glycoprotein study, or studies of the protein binding of dimethyl fumarate and monomethyl fumarate (a primary metabolite of dimethyl fumarate). 
Možnih tveganj medsebojnega delovanja zdravil v študijah in vitro zaviranja in indukcije CYP, študiji pglikoproteina ali študijah vezave beljakovin dimetilfumarata in monometilfumarata (primarnega presnovka dimetilfumarata) niso opredelili.
The forestomach of mice and rats does not have a human counterpart. 
Za predželodec miši in glodavcev pri ljudeh ni ustreznega organa.
Treatment initiation 
Uvajanje zdravljenja
However, when reported, most patients experienced grade 2 (< 0.8 × 109/L to 0.5 × 109/L) or grade 3 (<0.5 × 109/L to 0.2 × 109/L) lymphopenia (see section 4.4). 
V primerih, o katerih pa so poročali, pa je večina bolnikov imela limfopenijo 2. stopnje (od < 0,8 × 109/l do 0,5 × 109/l) ali 3. stopnje (od < 0,5 × 109/l do 0,2 × 109/l) (glejte poglavje 4.4).
This involves balancing the benefit of breast-feeding for your child, and the benefit of therapy for you. 
To pomeni pretehtanje koristi dojenja za vašega otroka in koristi zdravljenja za vas.
The most commonly reported adverse reactions leading to discontinuation (incidence >1%) in patients treated with Tecfidera were flushing (3%) and gastrointestinal events (4%). 
Najpogosteje poročani neželeni učinki, ki so povzročili prekinitev zdravljenja (incidenca > 1 %) pri bolnikih, zdravljenih z zdravilom Tecfidera, so bili vročinsko oblivanje (3 %) in prebavni dogodki (4 %).
Talk to your doctor about how to manage these side effects. 
O obvladovanju teh neželenih učinkov se pogovorite z zdravnikom.
No malformations were observed at any dose of dimethyl fumarate in rats or rabbits. 
Pri nobenem odmerku dimetilfumarata niso opazili deformacij pri podganah ali kuncih.
Tecfidera has not been studied in patients with severe renal or severe hepatic impairment and caution should, therefore, be used in these patients (see section 4.2). 
Zdravila Tecfidera niso preučili pri bolnikih s hudo okvaro ledvic ali jeter, zato je pri teh bolnikih potrebna previdnost (glejte poglavje 4.2).
The incidence of squamous cell papilloma and carcinoma in the nonglandular stomach (forestomach) was increased at equivalent exposure to the recommended human dose in mice and below exposure to the recommended human dose in rats (based on AUC). 
Incidenca ploščatoceličnega papiloma in karcinoma v proventrikulu (predželodcu) se je zvišala pri ustrezniku izpostavljenosti priporočenega odmerka pri ljudeh pri miših in pod ustreznikom priporočenega odmerka pri ljudeh pri podganah (na podlagi AUC).
The safety of Tecfidera in paediatric patients with multiple sclerosis below the age of 18 has not yet been established. 
Varnost zdravila Tecfidera pri otrocih z mutliplo sklerozo, mlajših od 18 let, še ni bila dokazana.
Dimethyl fumarate has been shown to cross the placental membrane into fetal blood in rats and rabbits, with ratios of fetal to maternal plasma concentrations of 0.48 to 0.64 and 0.1 respectively. 
Pokazalo se je, da dimetilfumarat pri podganah in kuncih prehaja skozi membrano posteljice v kri ploda, z razmerjem koncentracije v plazmi pri plodu glede na mater 0,48 proti 0,64 pri podganah in 0,1 pri kuncih.
In mice, the incidence of renal tubular carcinoma was increased at 75 mg/kg/day, at equivalent exposure (AUC) to the recommended human dose. 
Pri miših se je incidenca karcinoma ledvičnih tubulov zvišala pri 75 mg/kg/dan, kar je ustreznik izpostavljenosti (AUC) pri priporočenem odmerku pri ljudeh.
It is not known whether the active substance of Tecfidera passes into breast milk. 
Dojenje Ni znano, ali učinkovina zdravila Tecfidera prehaja v materino mleko.
Interruption of Tecfidera should be considered in patients with lymphocyte counts <0.5x109/L persisting for more than 6 months. 
O prekinitvi zdravljenja z zdravilom Tecfidera je treba razmisliti pri bolnikih, pri katerih je število limfocitov več kot 6 mesecev < 0,5 x 109/l.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
107c(7) Direktive 2001/83/ES, in vseh poznejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Tecfidera is not expected to affect your ability to drive and use machines. 
Ni pričakovano, da bi zdravilo Tecfidera vplivalo na vašo sposobnost upravljanja vozil in strojev.
What Tecfidera looks like and contents of the pack 
Izgled zdravila Tecfidera in vsebina pakiranja
There are no or limited amount of data from the use of dimethyl fumarate in pregnant women. 
Podatkov o uporabi dimetilfumarata pri nosečnicah ni oziroma so omejeni.
Tecfidera 240 mg gastro-resistant hard capsules are green and printed with ‘BG-12 240 mg' and are available in packs containing 56 or 168 capsules. 
Zdravilo Tecfidera 240 mg gastrorezistentne trde kapsule so zelene z natisom "BG-12 240 mg"; na voljo so v pakiranjih, ki vsebujejo po 56 ali 168 kapsul.
It is initially metabolised by esterases, which are ubiquitous in the gastrointestinal tract, blood and tissues, before it reaches the systemic circulation. 
Preden doseže sistemski obtok, ga presnovijo esteraze, ki so v prebavilih, krvi in tkivu prisotne povsod.
Dimethyl fumarate demonstrated therapeutic activity in multiple models of inflammatory and neuroinflammatory injury. 
Dimetilfumarat kaže terapevtski učinek pri več modelih vnetnih in nevrovnetnih poškodb.
The starting dose is 120 mg twice a day. 
Začetni odmerek je 120 mg dvakrat na dan.
Tecfidera has not been studied in combination with anti-neoplastic or immunosuppressive therapies and caution should, therefore, be used during concomitant administration. 
Zdravila Tecfidera niso preučili v kombinaciji z zdravili proti novotvorbam ali imunosupresivi, zato je potrebna pri sočasni uporabi s temi zdravili previdnost.
In phase III placebo-controlled studies, the incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with Tecfidera or placebo, respectively. 
V študijah 3. faze, nadzorovanih s placebom, je bila incidenca okužb (60 % v primerjavi s 58 %) in resnih okužb (2 % v primerjavi z 2 %) podobna pri bolnikih, zdravljenih z zdravilom Tecfidera in placebom.
Data from healthy volunteer studies suggest that dimethyl fumarate-associated flushing is likely to be prostaglandin mediated. 
Podatki iz študij pri zdravih prostovoljcih kažejo, da vročinsko oblivanje, povezano z dimetilfumaratom, verjetno posredujejo prostaglandini.
Tecfidera is a medicine that contains the active substance dimethyl fumarate. 
Zdravilo Tecfidera vsebuje učinkovino dimetilfumarat.
Cases of overdose with Tecfidera have been reported. 
Poročali so o primerih prevelikega odmerjanja zdravila Tecfidera.
What Tecfidera is and what it is used for What Tecfidera is 
Kaj je zdravilo Tecfidera in za kaj ga uporabljamo Kaj je zdravilo Tecfidera
No interaction studies have been performed with oral contraceptives containing other progestogens, however an effect of Tecfidera on their exposure is not expected. 
S peroralnimi kontraceptivi, ki vsebujejo druge progestogene, niso opravili študij medsebojnega delovanja, vendar ne pričakujemo učinka zdravila
There is no relevant use of Tecfidera in children aged less than 10 years for the indication of relapsing remitting multiple sclerosis. 
Zdravilo Tecfidera ni primerno za uporabo za indikacijo recidivno-remitentne multiple skleroze pri otrocih, starih manj kot 10 let.
Evidence from healthy volunteer studies suggests that Tecfidera-associated flushing is likely to be prostaglandin mediated. 
Dokazi, pridobljeni v študijah na zdravih prostovoljcih, kažejo, da vročinsko oblivanje, povezano z zdravilom Tecfidera, verjetno posredujejo prostaglandini.
Lymphocyte counts <0.5x109/l were observed in <1% of patients treated with placebo and 6% of patients treated with Tecfidera. 
Število limfocitov < 0,5 x 109/l so opazili pri < 1 % bolnikov, ki so prejemali placebo, in 6 % bolnikov, zdravljenih z zdravilom Tecfidera.
Progressive multifocal leukoencephalopathy (PML) 1 
Infekcijske in parazitske bolezni gastroenteritis pogosti progresivna multifokalna levkoencefalopatija (PML)1
PML has occurred in the setting of moderate to severe prolonged lymphopenia (see section 4.4). 
PML se je pojavljala v okviru zmerne do hude dolgotrajne limfopenije (glejte poglavje 4.4).
Placebo Tecfidera 240 mg twice a day 
placebo Tecfidera 240 mg dvakrat na dan placebo Tecfidera 240 mg dvakrat na dan glatiramer acetat
Patients treated with Tecfidera may develop severe prolonged lymphopenia (see section 4.8). 
Pri bolnikih, zdravljenih z zdravilom Tecfidera, se lahko razvije huda dolgotrajna limfopenija (glejte poglavje 4.8).
56 gastro-resistant hard capsules 168 gastro-resistant hard capsules 
56 gastrorezistentnih trdih kapsul 168 gastrorezistentnih trdih kapsul
The most common adverse reactions (incidence ≥10%) for patients treated with dimethyl fumarate were flushing and gastrointestinal events (i.e. diarrhoea, nausea, abdominal pain, abdominal pain upper). 
Povzetek varnostnega profila Najpogostejši neželeni učinki (incidenca ≥ 10 %) za bolnike, zdravljene z dimetilfumaratom, so bili vročinsko oblivanje in prebavni dogodki (tj. driska, navzea, trebušna bolečina, bolečine v zgornjem delu trebuha).
Findings in the forestomach of mice and rats consisted of squamous epithelial hyperplasia and hyperkeratosis; inflammation; and squamous cell papilloma and carcinoma in studies of 3 months or longer in duration. 
Izsledki v predželodcu miši in podgan so v 3-mesečnih in daljših študijah so bili sestavljeni iz ploščatocelične hiperplazije in hiperkeratoze epitelija in vnetje ter ploščatocelični papilom in karcinom.
A lymphocyte count <0.2x109/l was observed in 1 patient treated with Tecfidera and in no patients treated with placebo. 
< 0,2 x 109/l so opazili pri 1 bolniku, zdravljenim z zdravilom Tecfidera, in pri nobenem od bolnikov, ki so prejemali placebo.
Tecfidera is not recommended during pregnancy and in women of childbearing potential not using appropriate contraception (see section 4.5). 
Zdravila Tecfidera ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo ustrezne kontracepcije (glejte poglavje
Concomitant administration of non-live vaccines according to national vaccination schedules may be considered during Tecfidera therapy. 
Med zdravljenjem z zdravilom Tecfidera lahko pride v poštev sočasna uporaba neživih cepiv v skladu z nacionalnimi programi cepljenja.
In dogs that received daily oral doses of dimethyl fumarate for 11 months, the margin calculated for cortical atrophy was observed at 3 times the recommended dose based on AUC. 
Pri psih, ki so 11 mesecev prejemali dnevne peroralne odmerke dimetilfumarata, so opazili izračunano mejo za kortikalno atrofijo pri 3-kratniku priporočenega odmerka na osnovi AUC.
Resolution of the adverse reactions has been observed after treatment was discontinued. 
Ti neželeni učinki so izzveneli po prekinitvi zdravljenja.
The effect of Tecfidera on the ability to drive or use machines is not known. 
Učinek zdravila Tecfidera na sposobnost vožnje ali upravljanja strojev ni znan.
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) 
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA
Renal tubule epithelial regeneration, suggestive of injury, was observed in all species. 
Pri vseh vrstah so opazili regeneracijo epitelija ledvičnih tubulov, kar kaže na poškodbo.
Drug-induced liver injury, including liver enzyme increase (≥ 3 upper limit of normal (ULN)) and elevation of total bilirubin levels (≥ 2 ULN) can result from treatment with dimethyl fumarate. 
Zaradi zdravljenja z dimetilfumaratom lahko nastanejo okvare jeter, povzročene z zdravilom, vključno z zvišanjem jetrnih encimov (≥ 3 zgornja meja normalnih vrednosti (upper limit of normal - ULN)) in zvišanjem koncentracije celotnega bilirubina (≥ 2 ULN).
The incidence of gastrointestinal events (e.g. diarrhoea [14% versus 10%], nausea [12% versus 9%], upper abdominal pain [10% versus 6%], abdominal pain [9% versus 4%], vomiting [8% versus 5%] and dyspepsia [5% versus 3%]) was increased in patients treated with Tecfidera compared to placebo, respectively. 
9 %], bolečina v zgornjem delu trebuha [10 % v primerjavi s 6 %], bolečina v trebuhu [9 % v primerjavi s 4 %], bruhanje [8 % v primerjavi s 5 %] in dispepsija [5 % v primerjavi s 3 %]) je bila večja pri bolnikih, zdravljenih z zdravilom Tecfidera, kot pri bolnikih, zdravljenih s placebom.
Serious effects 
Resni neželeni učinki
Tecfidera has not been studied in patients with severe active gastrointestinal disease and caution should, therefore, be used in these patients. 
Zdravila Tecfidera niso preučili pri bolnikih s hudo aktivno boleznijo prebavil, zato je pri teh bolnikih potrebna previdnost.
In a clinical study involving a total of 71 patients with relapsing remitting multiple sclerosis, patients on Tecfidera 240 mg twice daily for at least 6 months (n=38) or non-pegylated interferon for at least 3 months (n=33), mounted a comparable immune response (defined as ≥2-fold increase from pre- to post-vaccination titer) to tetanus toxoid (recall antigen) and a conjugated meningococcal C polysaccharide vaccine (neoantigen), while the immune response to different serotypes of an unconjugated 23-valent pneumococcal polysaccharide vaccine (T-cell independent antigen) varied in both treatment groups. 
V klinični študiji, ki je zajela vsega skupaj 71 bolnikov z recidivno remitentno multiplo sklerozo, so bolniki, ki so prejemali zdravilo Tecfidera v odmerku 240 mg dvakrat na dan, vsaj 6 mesecev (n=38) ali nepegiliran interferon vsaj 3 mesece (n=33), razvili primerljiv imunski odziv (definiran kot ≥2-kratno zvečanje titra pred cepljenjem na titer po cepljenju) na tetanusni toksoid (spominski antigen) in na konjugirano meningokokno C polisaharidno cepivo
No untoward clinical consequences were observed in clinical trials. 
kliničnih preskušanjih niso opazili neugodnih kliničnih posledic.
(95% CI) 
Razmerje obetov (95-% IZ)
In the placebo-controlled studies, the incidence of flushing (34% versus 4%) and hot flush (7% versus 2%) was increased in patients treated with Tecfidera compared to placebo, respectively. 
V študijah, kontroliranih s placebom, se je incidenca vročinskega oblivanja (34 % v primerjavi s 4 %) in vročinskih valov (7 % v primerjavi z 2 %) zvišala pri bolnikih, zdravljenih z zdravilom Tecfidera v primerjavi z bolniki, zdravljenimi s placebom.
Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury1 
Bolezni jeter, žolčnika in žolčevodov zvišana aspartat aminotransferaza pogosti zvišana alanin aminotransferaza pogosti z zdravili povzročena okvara jeter1
Laboratory abnormalities 
Nenormalni laboratorijski testi
In monkeys that received daily oral doses of dimethyl fumarate for 12 months, single cell necrosis was observed at 2 times the recommended dose based on AUC. 
Pri opicah, ki so 12 mesecev prejemale dnevne peroralne odmerke dimetilfumarata, so opazili nekrozo posamičnih celic pri 2-kratniku priporočenega odmerka na osnovi AUC.
Changes in renal laboratory tests have been seen in clinical trials in subjects treated with dimethyl fumarate (see section 4.8). 
V kliničnih preskušanjih so pri bolnikih, zdravljenih z dimetilfumaratom, opazili spremembe ledvičnih laboratorijskih testov (glejte poglavje 4.8).
Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets. 
Zelene in bele gastrorezistentne trde kapsule, velikosti 0, z napisom ‘BG-12 120 mg', ki vsebujejo mikrotablete.
Tecfidera treatment should be started gradually to reduce the occurrence of flushing and gastrointestinal adverse reactions (see section 4.2). 
Zdravljenje z zdravilom Tecfidera je treba uvajati postopoma, da zmanjšamo pogostnost vročinskega oblivanja in neželenih učinkov na prebavila (glejte poglavje 4.2).
Following 240 mg twice a day administered with food, the median peak (Cmax) was 1.72 mg/l and overall area under the curve (AUC) exposure was 8.02 h.mg/l in subjects with multiple sclerosis. 
Po dajanju 240 mg dvakrat na dan s hrano je bila pri osebah z multiplo sklerozo mediana najvišje koncentracije (Cmax) 1,72 mg/l in celotna površina pod krivuljo (AUC)
The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class. 
Neželeni učinki so navedeni z izrazi, ki jih priporoča MedDRA, in glede na MedDRA organske sisteme.
How to take Tecfidera 
Kako jemati zdravilo Tecfidera
Dimethyl fumarate was negative in the in vivo micronucleus assay in the rat. 
Dimetilfumarat je bil pri podganah v preskusu mikronukleusov in vivo negativen.
These may affect more than 1 in 10 people: - reddening of the face or body feeling warm, hot, burning or itchy (flushing) - loose stools (diarrhoea) - feeling sick (nausea) - stomach pain or stomach cramps 
Pojavijo se lahko pri več kot 1 od 10 bolnikov: - rdečina obraza ali telesa, občutek toplote, vročine, pekoč občutek ali občutek srbenja (vročinsko oblivanje) - redko blato (driska) - siljenje na bruhanje (navzea)
No studies have been performed evaluating the efficacy and safety of Tecfidera when switching patients from other disease modifying therapies to Tecfidera. 
Predhodno zdravljenje z imunosupresivnimi ali imunomodulirajočimi zdravili Študije, ki bi ocenjevale učinkovitost in varnost zdravila Tecfidera pri prehodu zdravljenja bolnikov z drugih zdravljenj, ki spreminjajo potek bolezni, na zdravljenje z zdravilom Tecfidera, niso bile izvedene.
Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg' containing microtablets. 
Zelene gastrorezistentne trde kapsule, velikosti 0, z napisom ‘BG-12 240 mg', ki vsebujejo mikrotablete.
How Tecfidera works 
Kako deluje zdravilo Tecfidera
Regular dose 240 mg twice a day. 
Redni odmerek 240 mg dvakrat na dan.
Feeling hot 
Vročinsko oblivanje
Upon treatment with Tecfidera, mean lymphocyte counts decreased over the first year with a subsequent plateau. 
Po zdravljenju z zdravilom Tecfidera se je povprečno število limfocitov v prvem letu zmanjšalo, preden je doseglo konstantno raven.
A single 240 mg 14C-dimethyl fumarate dose study identified glucose as the predominant metabolite in human plasma. 
dimetilfumarata so identificirali glukozo kot prevladujoči presnovek v plazmi pri človeku.
Hazard ratio (95% CI) Proportion with 24 week confirmed disability progression Hazard ratio (95% CI) 
Št. oseb Letni delež recidiva Razmerje pogostnosti (95-% IZ) Delež recidiva Razmerje tveganj (95-% IZ) Delež z 12-tedenskim potrjenim napredovanjem bolezni Razmerje tveganj (95-% IZ) Delež s 24-tedenskim potrjenim napredovanjem bolezni Razmerje tveganj (95-% IZ)
In clinical trials, 3 patients out of a total of 2,560 patients treated with dimethyl fumarate experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions. 
V kliničnih preskušanjih so 3 bolniki od skupaj 2.560 bolnikov, zdravljenih z dimetilfumaratom,
Consider withholding Tecfidera treatment in patients with serious infections until the infection has resolved (see section 4.8). 
Pri bolnikih z resnimi okužbami je treba razmisliti o začasni prekinitvi zdravljenja z zdravilom Tecfidera, dokler okužba ne izzveni (glejte poglavje 4.8).
Tecfidera 120 mg gastro-resistant hard capsules are green and white and printed with ‘BG-12 120 mg' and are available in packs containing 14 capsules. 
Zdravilo Tecfidera 120 mg gastrorezistentne trde kapsule so zelene in bele z natisom "BG-12 120 mg"; na voljo so v pakiranjih, ki vsebujejo po 14 kapsul.
Hypotension1 
neznana hipotenzija1
Herpes zoster (shingles) may occur with Tecfidera treatment. 
Pri zdravljenju z zdravilom Tecfidera se lahko pojavi herpes zoster (pasovec).
Tecfidera is for oral use 
Zdravilo Tecfidera je za peroralno uporabo.
In case of unclear symptoms Fanconi syndrome should be considered and appropriate examinations should be performed. 
Fanconijev sindrom in opraviti ustrezne preiskave.
However, Tecfidera should be taken with food due to improved tolerability with respect to flushing or gastrointestinal adverse events (see section 4.2). 
Vendar pa je treba zdravilo Tecfidera jemati s hrano zaradi boljšega prenašanja vročinskega oblivanja ali prebavnih neželenih učinkov (glejte poglavje 4.2).
Oral administration of dimethyl fumarate to male rats at 75, 250, and 375 mg/kg/day prior to and during mating had no effects on male fertility up to the highest dose tested (at least 2 times the recommended dose on an AUC basis). 
Peroralno dajanje dimetilfumarata podganjim samcem v odmerkih 75, 250 in 375 mg/kg/dan pred parjenjem in med njim ni vplivalo na plodnost samcev do najvišjega testiranega odmerka (vsaj 2kratnik priporočenega odmerka na osnovi AUC).
The mechanism of dimethyl fumarate induced anaphylaxis is unknown. 
Mehanizem anafilaksije, ki jo povzroča dimetilfumarat, je neznan.
Due to the design of the studies, high disease activity was defined as follows: - Patients with 2 or more relapses in one year, and with one or more Gd-enhancing lesions on brain MRI (n=42 in DEFINE; n=51 in CONFIRM) or, - Patients who have failed to respond to a full and adequate course (at least one year of treatment) of beta-interferon, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or patients having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years (n=177 in DEFINE; n=141 in CONFIRM). 
(n = 42 za DEFINE; n = 51 za CONFIRM) ali - bolniki, ki se niso odzivali na poln in ustrezen cikel (vsaj eno leto zdravljenja) z betainterferoni, ki so imeli v preteklem letu vsaj 1 recidiv, medtem ko so se zdravili, in ki so imeli vsaj 9 T2-hiperintenzivnih lezij na MRS možganov ali vsaj 1 lezijo, vidno z Gd, ali bolniki, ki so v preteklem letu imeli nespremenjeno ali večje število lezij v primerjavi s prejšnjima
Overall, 3% of patients treated with Tecfidera discontinued due to flushing. 
Na splošno so se zaradi vročinskega oblivanja 3 % bolnikov, zdravljenih z zdravilom Tecfidera, prenehali zdraviti.