natgillin/translations-raw huggingface dataset:
The most commonly reported adverse reactions leading to discontinuation (incidence >1%) in patients treated with Tecfidera were flushing (3%) and gastrointestinal events (4%). 
Najčešće prijavljene nuspojave koje su dovele do prekida liječenja (incidencija >1%) u bolesnika liječenih Tecfiderom su navala crvenila (3%), i gastrointestinalne smetnje (4%).
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. 
Tecfidera 240 mg tvrde želučanootporne kapsule su zelene boje s otisnutom oznakom „BG-12 240 mg“ i dostupne su u pakiranju od 56 ili 168 kapsula.
Gender and age did not have a clinically significant impact on the pharmacokinetics of dimethyl fumarate. 
Spol i dob nisu klinički značajno utjecali na farmakokinetiku dimetilfumarata.
It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk. 
Nije poznato izlučuju li se dimetilfumarat ili njegovi metaboliti u majčino mlijeko.
Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys. 
Primijećene su promjene na bubrezima nakon ponavljane peroralne primjene dimetilfumarata u miševa, štakora, pasa i majmuna.
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). 
Najčešće nuspojave (incidencija ≥10%) za bolesnike liječene dimetilfumaratom bile su navala crvenila i gastrointestinalne smetnje (npr. proljev, mučnina, bol u abdomenu, bol u gornjem dijelu abdomena).
Dimethyl fumarate has been shown to up regulate Nrf2-dependent antioxidant genes in patients (e.g. NAD(P)H dehydrogenase, quinone 1; [NQO1]). 
Pokazalo se da dimetilfumarat potiče ekspresiju o Nrf2 ovisnih antioksidativnih gena u bolesnika (npr. NAD(P)H dehidrogenaza, kinon 1; [NQO1]).
Angioedema1 
nepoznato angioedem1
Interstitial fibrosis and cortical atrophy were observed at 6 times the recommended dose based on AUC. 
Intersticijska fibroza i kortikalna atrofija opažene su na temelju AUC-a pri dozi 6 puta većoj od preporučene.
Do not store above 30ºC Keep the blisters in the outer carton in order to protect from light 
Ne čuvati na temperaturi iznad 30ºC Blistere čuvati u vanjskom pakiranju radi zaštite od svjetlosti
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. 
Dimetilfumarat i monometilfumarat, primarni metabolit dimetilfumarata, značajno su smanjili aktivaciju imunoloških stanica i posljedično otpuštanje proupalnih citokina kao odgovor na imunološki podražaj u pretkliničkim modelima.
In the testes, degeneration of the seminiferous epithelium was seen in rats and dogs. 
Primijećena je degeneracija seminifernog epitela u testisima štakora i pasa.
In the post-marketing setting most cases of herpes zoster infection were non-serious and resolved with treatment. 
U razdoblju nakon stavljanja lijeka u promet, većina slučajeva herpes zoster infekcija nije bila ozbiljna te se razriješila liječenjem.
Nonclinical studies in rodent, rabbits, and monkeys were conducted with a dimethyl fumarate suspension (dimethyl fumarate in 0.8% hydroxypropyl methylcellulose) administered by oral gavage. 
Pretklinička ispitivanja provedena su u glodavaca, kunića i majmuna sa suspenzijom dimetilfumarata (dimetilfumarat u 0,8% hidroksipropilmetilcelulozi) koja je primijenjena gastričnom sondom.
There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or <0.5x109/L (see Section 4.8). 
Nije bilo povećane incidencije ozbiljnih infekcija opaženih u bolesnika s brojem limfocita <0,8x109/l ili <0,5x109/l (vidjeti dio 4.8).
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). 
Nisu identificirane potencijalne opasnosti od interakcija lijekova u in vitro ispitivanjima inhibicije i indukcije CYP-a, ispitivanju p-glikoproteina ili ispitivanjima vezanja dimetilfumarata i monometilfumarata (primarni metabolit dimetilfumarata) na proteine.
A decision must be made whether to discontinue breast-feeding or to discontinue Tecfidera therapy. 
Potrebno je odlučiti treba li prekinuti dojenje ili terapiju
The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia). 
glikozurija (uz normalne razine šećera u krvi), hiperaminoacidurija i fosfaturija (moguće prisutna istodobno s hipofosfatemijom).
The starting dose is 120 mg twice a day. 
Početna doza je 120 mg dvaput na dan.
No interaction studies have been performed with oral contraceptives containing other progestogens, however an effect of Tecfidera on their exposure is not expected. 
Iako nisu provedena ispitivanja interakcija s oralnim kontraceptivima koji sadrže druge progestagene, učinak Tecfidere na izloženost tim kontraceptivima se ne očekuje.
In mice, the incidence of renal tubular carcinoma was increased at 75 mg/kg/day, at equivalent exposure (AUC) to the recommended human dose. 
U miševa, incidencija bubrežnog tubularnog karcinoma bila je povećana pri 75 mg/kg/dan, pri ekvivalentnoj izloženosti (AUC) preporučene ljudske doze.
Tecfidera has no or negligible influence on the ability to drive and use machines. 
Tecfidera ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Hazard ratio (95% CI) Proportion with 24 week confirmed disability progression Hazard ratio (95% CI) 
Omjer hazarda (95% CI) Udio progresije onesposobljenosti potvrđeno nakon 24 tjedna
Serious effects 
Ozbiljne nuspojave
In addition, 17% of patients had an EDSS score >3.5, 32% had ≥2 relapses in the prior year and 30% had previously received other approved MS treatments. 
EDSS bodova >3,5, 32% je imalo ≥2 relapsa u prethodnoj godini, a 30% je prethodno dobilo drugo odobreno liječenje za MS.
Cases of Fanconi syndrome have been reported for a medicinal product containing dimethyl fumarate in combination with other fumaric acid esters. 
Prijavljeni su slučajevi Fanconijeva sindroma povezani s primjenom lijeka koji sadrži dimetilfumarat u kombinaciji s drugim esterima fumaratne kiseline.
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. 
Kod ljudi, esteraze ekstenzivno metaboliziraju dimetilfumarat prije nego što dođe u sistemsku cirkulaciju, a daljnji metabolizam se odvija kroz ciklus trikarboksilatne kiseline, bez posredovanja sustava citokroma P450 (CYP).
In humans, dimethyl fumarate is extensively metabolised with less than 0.1% of the dose excreted as unchanged dimethyl fumarate in urine. 
U ljudi, dimetilfumarat je vrlo podložan metaboliziranju, tako da se manje od 0,1% doze izlučuje u nepromijenjenom obliku u mokraći.
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. 
Nakon što su ispitanici s multiplom sklerozom uzimali lijek od 240 mg dva puta dnevno s hranom, medijan vršne vrijednosti (Cmax) je bio 1,72 mg/l, a sveukupna izloženost prema površini ispod krivulje (AUC) bila je 8,02 h.mg/l.
Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed. 
Unutar mjesec dana mora se nastaviti s preporučenom dozom održavanja od 240 mg dvaput na dan.
Patients treated with Tecfidera may develop severe prolonged lymphopenia (see section 4.8). 
Bolesnici liječeni Tecfiderom mogu razviti tešku produljenu limfopeniju (vidjeti dio 4.8).
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). 
- Bolesnici s 2 ili više relapsa u jednoj godini i s jednom ili više Gd-pozitivnih lezija na MR mozga (n=42 u DEFINE; n=51 u CONFIRM) ili, - Bolesnici koji nisu imali odgovor na potpuno i odgovarajuće liječenje (barem godinu dana liječenja) beta-interferonom, nakon što su imali barem 1 relaps u prethodnoj godini dok su bili na terapiji, i najmanje 9 T2-hiperintenzivnih lezija u kranijalnoj MR ili barem 1 Gd-pozitivnu leziju, ili bolesnici s nepromijenjenom ili povećanom stopom relapsa u prethodnoj godini u usporedbi s prethodne 2 godine (n=177 u DEFINE; n=141 u CONFIRM).
Progressive multifocal leukoencephalopathy (PML) 1 
Infekcije i infestacije gastroenteritis često progresivna multifokalna leukoencefalopatija (PML)1
Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera. 
Dok uzimate Tecfideru, tvari nazvane ketoni a koje se prirodno stvaraju u tijelu, pojavljuju se vrlo često u testovima mokraće.
Overall, 3% of patients treated with Tecfidera discontinued due to flushing. 
Sveukupno 3% bolesnika liječenih Tecfiderom je prekinulo liječenje zbog navale crvenila.
Since early diagnosis of Fanconi syndrome and discontinuation of the potentially causative drug, e.g. dimethyl fumarate, are important steps to prevent the onset of renal impairment and osteomalacia, the PRAC recommends the inclusion of a warning in SmPC section 4.4 to make physicians aware of the potential risk of Fanconi syndrome including the description of corresponding symptoms. 
Obzirom da su rana dijagnoza Fanconijeva sindroma i prekid primjene potencijalnog lijeka uzročnika primjerice dimetilfumarata, važni koraci za sprječavanje pojave oštećenja bubrega i osteomalacije, PRAC preporučuje uključivanje upozorenja u dio 4.4 sažetka opisa svojstava lijeka, kako bi se liječnike upozorilo na potencijalni rizik od
Talk to your doctor before taking Tecfidera if you have: - severe kidney disease - severe liver disease - a disease of the stomach or bowel - a serious infection (such as pneumonia) 
Obavijestite svog liječnika prije uzimanja Tecfidere ako imate: - tešku bolest bubrega - tešku bolest jetre
Interruption of Tecfidera should be considered in patients with lymphocyte counts <0.5x109/L persisting for more than 6 months. 
Prekid primjene Tecfidere potrebno je razmotriti u bolesnika s brojem limfocita <0,5x109/l koji traje dulje od 6 mjeseci.
In addition, 16% of patients had an EDSS score >3.5, 28% had ≥2 relapses in the prior year and 42% had previously received other approved MS treatments. 
EDSS bodova > 3,5, 28% je imalo ≥ 2 relapsa u prethodnoj godini, a 42% je prethodno dobilo drugo odobreno liječenje za MS.
Clinical factors, evaluation of any laboratory and imaging investigations could be included as part of this reconsideration. 
Kao dio ovog ponovnog razmatranja mogu se uključiti klinički čimbenici i ocjenjivanje laboratorijskih pretraga kao i pretraga oslikavanja.
Tecfidera treatment should be started gradually to reduce the occurrence of flushing and gastrointestinal adverse reactions (see section 4.2). 
Početak liječenja Liječenje Tecfiderom treba započeti postupno kako bi se smanjila učestalost navale crvenila i gastrointestinalnih nuspojava (vidjeti dio 4.2).
Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients. 
Dimetilfumarat nije ispitivan u bolesnika s već postojećim niskim brojem limfocita pa je potreban oprez pri liječenju takvih bolesnika.
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. 
U kliničkom ispitivanju koje je uključilo 71 bolesnika s relapsno remitirajućom multiplom sklerozom, bolesnici koji su primali Tecfideru u dozi od 240 mg dvaput dnevno najmanje 6 mjeseci (n=38) ili nepegilirani interferon najmanje 3 mjeseca (n=33) razvili su usporediv imunološki odgovor (definiran kao povećanje titra poslije cijepljenja za ≥2 puta u odnosu na onaj prije cijepljenja) na toksoid tetanusa (anamnestički antigen) i polisaharidno konjugirano cjepivo protiv meningokoka skupine C (novi antigen), dok je imunološki odgovor na različite serotipove nekonjugiranog 23-valentnog polisaharidnog pneumokoknog cjepiva (antigen neovisan o T-stanicama)
A lymphocyte count <0.2x109/l was observed in 1 patient treated with Tecfidera and in no patients treated with placebo. 
Broj limfocita <0,2x109/l opažen je kod 1 bolesnika liječenog Tecfiderom i kod niti jednog bolesnika na placebu.
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. 
U placebom kontroliranim ispitivanjima faze 3 incidencija infekcija (60% naspram 58%) i ozbiljnih infekcija (2% naspram 2%) bila je slična u bolesnika liječenih Tecfiderom ili placebom.
In the placebo-controlled studies, measurement of urinary ketones (1+ or greater) was higher in patients treated with Tecfidera (45%) compared to placebo (10%). 
U placebom kontroliranim ispitivanjima mjerenje ketona u mokraći (1+ ili više) bilo je više u bolesnika liječenih Tecfiderom (45%) u usporedbi s placebom (10%).
Over the full treatment period (120-week), ARR was 0.2 representing an 84.5% relative reduction in relapses (n=20; 95% CI [66.8, 92.8], p<0.0001), when compared to the year prior to treatment initiation. 
(n = 20; 95% CI [66,8, 92,8], p < 0,0001) u odnosu na godinu prije početka liječenja.
Efficacy (see table below) and safety were demonstrated in subjects with Expanded Disability Status Scale (EDSS) scores ranging from 0 to 5 inclusive, who had experienced at least 1 relapse during the year prior to randomisation, or, in the 6 weeks before randomisation had a brain Magnetic Resonance Imaging (MRI) demonstrating at least one gadolinium-enhancing (Gd+) lesion. 
Expanded Disability Status Scale, EDSS) u rasponu od 0 do 5 uključivo, koji su doživjeli barem 1 relaps tijekom godine prije randomizacije, ili im je u 6 tjedana prije randomizacije provedena magnetska rezonancija (MR) mozga koja je pokazala barem jednu gadolinij-pozitivnu (Gd+) leziju.
Tecfidera is not expected to affect your ability to drive and use machines. 
Ne očekuje se da će Tecfidera utjecati na sposobnost upravljanja vozilima i rada na strojevima.
Adverse reactions, which were more frequently reported in Tecfidera versus placebo-treated patients, are presented in the table below. 
Nuspojave, koje su češće prijavljene u bolesnika koji su primali Tecfideru u odnosu na bolesnike koji su primali placebo, prikazane su u donjoj tablici.
Increase of liver enzymes and cases of drug-induced liver injury (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN), have been reported in post marketing experience following Tecfidera administration, which resolved upon treatment discontinuation. 
Povišenje jetrenih enzima i slučajevi oštećenja jetre izazvanog lijekom (povišenja transaminaza ≥3 puta GGN uz istodobna povišenja ukupnog bilirubina >2 puta GGN) prijavljeni su kod primjene Tecfidere nakon stavljanja lijeka u promet, a nestali su s prestankom liječenja.
There are no or limited amount of data from the use of dimethyl fumarate in pregnant women. 
Nema podataka ili su podaci o primjeni dimetilfumarata u trudnica ograničeni.
The chronic dog study was conducted with oral administration of the dimethyl fumarate capsule. 
Ispitivanje kronične toksičnosti u pasa provedeno je peroralnom primjenom kapsula dimetilfumarata.
Elevations of alanine aminotransferase and aspartate aminotransferase ≥3 times ULN, respectively, were seen in 5% and 2% of patients treated with placebo and 6% and 2% of patients treated with Tecfidera. 
Povišenje razina alanin aminotransferaze i aspartat aminotransferaze ≥3 puta GGN, primijećeno je kod 5% odnosno 2% bolesnika koji su dobivali placebo te 6% i 2% bolesnika liječenih Tecfiderom.
In the MRI cohort 36% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 1.4). 
U MR kohorti 36% bolesnika koji su ušli u ispitivanje imali su Gd+ lezije na početku (srednja vrijednost broja Gd+ lezija 1,4).
Two, 2-year, randomised, double-blind, placebo controlled studies [Study 1 (DEFINE) with 1234 subjects and Study 2 (CONFIRM) with 1417 subjects] of subjects with relapsing-remitting multiple sclerosis (RRMS) were performed. 
Provedena su dva 2-godišnja, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja u ispitanika s relapsno-remitirajućom multiplom sklerozom (RRMS) [Ispitivanje 1 (DEFINE) s 1234 ispitanika i Ispitivanje 2 (CONFIRM) s 1417 ispitanika].
It is not known whether the active substance of Tecfidera passes into breast milk. 
Nije poznato izlučuje li se djelatna tvar iz Tecfidere u majčino mlijeko.
The active substance is dimethyl fumarate. 
Djelatna tvar je dimetilfumarat.
Patients subsequently entered an extension study for a further 96 weeks. 
Bolesnici su potom sudjelovali u nastavku ispitivanja tijekom dodatnih
Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury1 
Poremećaji jetre i žuči povišena aspartat aminotransferaza često povišena alanin aminotransferaza često oštećenje jetre izazvano lijekom1 nepoznato
How to take Tecfidera 
Kako uzimati Tecfideru
In Phase 3 studies in MS patients, upon treatment with Tecfidera mean lymphocyte counts decreased on average by approximately 30% of their baseline value over the first year with a subsequent plateau. 
U ispitivanjima faze 3 u bolesnika s multiplom sklerozom, nakon liječenja Tecfiderom, srednja vrijednost broja limfocita smanjivala se u prosjeku za otprilike 30% od početne vrijednosti tijekom prve godine nakon čega je uslijedio plato.
The effect of Tecfidera on the ability to drive or use machines is not known. 
Učinak Tecfidere na sposobnost upravljanja vozilima i rada na strojevima nije poznat.
Dimethyl fumarate and mono-methylfumarate were negative in a battery of in vitro assays (Ames, chromosomal aberration in mammalian cells). 
Dimetilfumarat i monometilfumarat bili su negativni u nizu in vitro testova za ispitivanje mutagenosti (Amesov test, kromosomska aberacija u stanicama sisavaca).
In clinical trials, 34% of Tecfidera treated patients experienced flushing. 
U kliničkim ispitivanjima kod 34% bolesnika liječenih Tecfiderom pojavila se navala crvenila.
As dimethyl fumarate and monomethyl fumarate are metabolised by esterases, without the involvement of the CYP450 system, evaluation of phamacokinetics in individuals with hepatic impairment was not conducted. 
Budući da esteraze metaboliziraju dimetilfumarat i monometilfumarat, bez posredovanja sustava CYP450, procjena farmakokinetike u pojedinaca s oštećenjem jetre nije provedena.
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). 
Međutim, unutar prijavljenih slučajeva u većine bolesnika prijavljena je limfopenija 2. stupnja (< 0,8 × 109/l do 0,5 × 109/l) ili 3. stupnja (< 0,5 × 109/l do 0,2 × 109/l) (vidjeti dio 4.4).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER FOLIJA
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). 
Tecfidera nije ispitivana u bolesnika s teškim oštećenjem bubrega ili jetre pa je potreban oprez pri liječenju takvih bolesnika (vidjeti dio 4.2).
In the majority of patients who experienced gastrointestinal events, it was mild or moderate in severity. 
U većine bolesnika kod kojih su se javile gastrointestinalne smetnje, one su bile blage ili umjerene.
Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets. 
Zelene i bijele tvrde želučanootporne kapsule, veličine 0, s otisnutom oznakom „BG-12 120 mg“, koje sadrže mikrotablete.
Small numerical differences in the response to tetanus toxoid and pneumococcal serotype 3 polysaccharide were noted in favour of non-pegylated interferon. 
Zabilježen je nešto veći broj bolesnika s odgovorom na toksoid tetanusa i pneumokokni polisaharid serotipa 3 u skupini koja je primala nepegilirani interferon.
Upon treatment with Tecfidera, mean lymphocyte counts decreased over the first year with a subsequent plateau. 
Nakon liječenja Tecfiderom, srednja vrijednost broja limfocita smanjivala se tijekom prve godine, nakon čega je uslijedio plato.
Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4). 
Potreban je oprez u liječenju bolesnika s teškim oštećenjem bubrega ili teškim oštećenjem jetre (vidjeti dio 4.4).
Lymphocyte counts <0.5x109/l were observed in <1% of patients treated with placebo and 6% of patients treated with Tecfidera. 
Vrijednosti broja limfocita <0,5x109/l opažene su u <1% bolesnika na placebu i u 6% bolesnika liječenih Tecfiderom.
The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class. 
Nuspojave su prikazane kao preporučeni MedDRA termini prema MedDRA klasifikaciji organskih sustava.
In the MRI cohort 45% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 2.4). 
U MR kohorti 45% bolesnika koji su ušli u ispitivanje imali su Gd+ lezije na početku (srednja vrijednost broja Gd+ lezija 2,4).
Regular dose 240 mg twice a day. 
Redovna doza 240 mg dva puta na dan
Not known (frequency cannot be estimated from the available data) 
- smanjenje broja krvnih pločica Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
Changes in renal laboratory tests have been seen in clinical trials in subjects treated with dimethyl fumarate (see section 4.8). 
U kliničkim ispitivanjima u ispitanika liječenih dimetilfumaratom primijećene su promjene u laboratorijskim testovima bubrega (vidjeti dio 4.8).
In clinical studies with psoriasis patients, dimethyl fumarate affected lymphocyte phenotypes through a down-regulation of pro-inflammatory cytokine profiles (TH1, TH17), and biased towards anti-inflammatory production (TH2). 
dimetilfumarat je utjecao na fenotipove limfocita preko smanjenja profila proupalnih citokina (TH1, TH17) te je bio pristran prema protuupalnoj produkciji (TH2).
Preclinical studies indicate that dimethyl fumarate pharmacodynamic responses appear to be primarily mediated through activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway. 
Pretklinička ispitivanja pokazuju da dimetilfumarat izaziva farmakodinamičke odgovore prvenstveno aktivacijom signalnog puta nuklearnog transkripcijskog faktora Nrf2 [engl. nuclear factor