FrancophonIA/ELRC3.0 huggingface dataset:
English: In humans, dimethyl fumarate is extensively metabolised with less than 0.1% of the dose excreted as unchanged dimethyl fumarate in urine.
Croatian: U ljudi, dimetilfumarat je vrlo podložan metaboliziranju, tako da se manje od 0,1% doze izlučuje u nepromijenjenom obliku u mokraći.
English: 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.
Croatian: 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.
English: Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.
Croatian: Unutar mjesec dana mora se nastaviti s preporučenom dozom održavanja od 240 mg dvaput na dan.
English: Patients treated with Tecfidera may develop severe prolonged lymphopenia (see section 4.8).
Croatian: Bolesnici liječeni Tecfiderom mogu razviti tešku produljenu limfopeniju (vidjeti dio 4.8).
English: 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).
Croatian: - 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).
English: Progressive multifocal leukoencephalopathy (PML) 1
Croatian: Infekcije i infestacije gastroenteritis često progresivna multifokalna leukoencefalopatija (PML)1
English: Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera.
Croatian: Dok uzimate Tecfideru, tvari nazvane ketoni a koje se prirodno stvaraju u tijelu, pojavljuju se vrlo često u testovima mokraće.
English: Overall, 3% of patients treated with Tecfidera discontinued due to flushing.
Croatian: Sveukupno 3% bolesnika liječenih Tecfiderom je prekinulo liječenje zbog navale crvenila.
English: 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.
Croatian: 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
English: 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)
Croatian: Obavijestite svog liječnika prije uzimanja Tecfidere ako imate: - tešku bolest bubrega - tešku bolest jetre
English: Interruption of Tecfidera should be considered in patients with lymphocyte counts <0.5x109/L persisting for more than 6 months.
Croatian: Prekid primjene Tecfidere potrebno je razmotriti u bolesnika s brojem limfocita <0,5x109/l koji traje dulje od 6 mjeseci.
English: 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.
Croatian: EDSS bodova > 3,5, 28% je imalo ≥ 2 relapsa u prethodnoj godini, a 42% je prethodno dobilo drugo odobreno liječenje za MS.
English: Clinical factors, evaluation of any laboratory and imaging investigations could be included as part of this reconsideration.
Croatian: Kao dio ovog ponovnog razmatranja mogu se uključiti klinički čimbenici i ocjenjivanje laboratorijskih pretraga kao i pretraga oslikavanja.
English: Tecfidera treatment should be started gradually to reduce the occurrence of flushing and gastrointestinal adverse reactions (see section 4.2).
Croatian: Početak liječenja Liječenje Tecfiderom treba započeti postupno kako bi se smanjila učestalost navale crvenila i gastrointestinalnih nuspojava (vidjeti dio 4.2).
English: Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients.
Croatian: Dimetilfumarat nije ispitivan u bolesnika s već postojećim niskim brojem limfocita pa je potreban oprez pri liječenju takvih bolesnika.
English: 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.
Croatian: 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)
English: A lymphocyte count <0.2x109/l was observed in 1 patient treated with Tecfidera and in no patients treated with placebo.
Croatian: Broj limfocita <0,2x109/l opažen je kod 1 bolesnika liječenog Tecfiderom i kod niti jednog bolesnika na placebu.
English: 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.
Croatian: 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.
English: In the placebo-controlled studies, measurement of urinary ketones (1+ or greater) was higher in patients treated with Tecfidera (45%) compared to placebo (10%).
Croatian: U placebom kontroliranim ispitivanjima mjerenje ketona u mokraći (1+ ili više) bilo je više u bolesnika liječenih Tecfiderom (45%) u usporedbi s placebom (10%).
English: 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.
Croatian: (n = 20; 95% CI [66,8, 92,8], p < 0,0001) u odnosu na godinu prije početka liječenja.
English: 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.
Croatian: 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.
English: Tecfidera is not expected to affect your ability to drive and use machines.
Croatian: Ne očekuje se da će Tecfidera utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: Adverse reactions, which were more frequently reported in Tecfidera versus placebo-treated patients, are presented in the table below.
Croatian: Nuspojave, koje su češće prijavljene u bolesnika koji su primali Tecfideru u odnosu na bolesnike koji su primali placebo, prikazane su u donjoj tablici.
English: 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.
Croatian: 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.
English: There are no or limited amount of data from the use of dimethyl fumarate in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni dimetilfumarata u trudnica ograničeni.
English: The chronic dog study was conducted with oral administration of the dimethyl fumarate capsule.
Croatian: Ispitivanje kronične toksičnosti u pasa provedeno je peroralnom primjenom kapsula dimetilfumarata.
English: 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.
Croatian: 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.
English: In the MRI cohort 36% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 1.4).
Croatian: U MR kohorti 36% bolesnika koji su ušli u ispitivanje imali su Gd+ lezije na početku (srednja vrijednost broja Gd+ lezija 1,4).
English: 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.
Croatian: 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].
English: It is not known whether the active substance of Tecfidera passes into breast milk.
Croatian: Nije poznato izlučuje li se djelatna tvar iz Tecfidere u majčino mlijeko.
English: Teл: +359 2 962 12 00
Croatian: ТП ЕВОФАРМА Teл: +359 2 962 12 00
English: The active substance is dimethyl fumarate.
Croatian: Djelatna tvar je dimetilfumarat.
English: Patients subsequently entered an extension study for a further 96 weeks.
Croatian: Bolesnici su potom sudjelovali u nastavku ispitivanja tijekom dodatnih
English: Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury1
Croatian: Poremećaji jetre i žuči povišena aspartat aminotransferaza često povišena alanin aminotransferaza često oštećenje jetre izazvano lijekom1 nepoznato
English: How to take Tecfidera
Croatian: Kako uzimati Tecfideru
English: 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.
Croatian: 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.
English: The effect of Tecfidera on the ability to drive or use machines is not known.
Croatian: Učinak Tecfidere na sposobnost upravljanja vozilima i rada na strojevima nije poznat.
English: Dimethyl fumarate and mono-methylfumarate were negative in a battery of in vitro assays (Ames, chromosomal aberration in mammalian cells).
Croatian: Dimetilfumarat i monometilfumarat bili su negativni u nizu in vitro testova za ispitivanje mutagenosti (Amesov test, kromosomska aberacija u stanicama sisavaca).
English: In clinical trials, 34% of Tecfidera treated patients experienced flushing.
Croatian: U kliničkim ispitivanjima kod 34% bolesnika liječenih Tecfiderom pojavila se navala crvenila.
English: 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.
Croatian: Budući da esteraze metaboliziraju dimetilfumarat i monometilfumarat, bez posredovanja sustava CYP450, procjena farmakokinetike u pojedinaca s oštećenjem jetre nije provedena.
English: 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).
Croatian: 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).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER FOLIJA
English: 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).
Croatian: Tecfidera nije ispitivana u bolesnika s teškim oštećenjem bubrega ili jetre pa je potreban oprez pri liječenju takvih bolesnika (vidjeti dio 4.2).
English: In the majority of patients who experienced gastrointestinal events, it was mild or moderate in severity.
Croatian: U većine bolesnika kod kojih su se javile gastrointestinalne smetnje, one su bile blage ili umjerene.
English: Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets.
Croatian: Zelene i bijele tvrde želučanootporne kapsule, veličine 0, s otisnutom oznakom „BG-12 120 mg“, koje sadrže mikrotablete.
English: Small numerical differences in the response to tetanus toxoid and pneumococcal serotype 3 polysaccharide were noted in favour of non-pegylated interferon.
Croatian: Zabilježen je nešto veći broj bolesnika s odgovorom na toksoid tetanusa i pneumokokni polisaharid serotipa 3 u skupini koja je primala nepegilirani interferon.
English: Upon treatment with Tecfidera, mean lymphocyte counts decreased over the first year with a subsequent plateau.
Croatian: Nakon liječenja Tecfiderom, srednja vrijednost broja limfocita smanjivala se tijekom prve godine, nakon čega je uslijedio plato.
English: Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4).
Croatian: Potreban je oprez u liječenju bolesnika s teškim oštećenjem bubrega ili teškim oštećenjem jetre (vidjeti dio 4.4).
English: Lymphocyte counts <0.5x109/l were observed in <1% of patients treated with placebo and 6% of patients treated with Tecfidera.
Croatian: Vrijednosti broja limfocita <0,5x109/l opažene su u <1% bolesnika na placebu i u 6% bolesnika liječenih Tecfiderom.
English: The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Croatian: Nuspojave su prikazane kao preporučeni MedDRA termini prema MedDRA klasifikaciji organskih sustava.
English: In the MRI cohort 45% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 2.4).
Croatian: U MR kohorti 45% bolesnika koji su ušli u ispitivanje imali su Gd+ lezije na početku (srednja vrijednost broja Gd+ lezija 2,4).
English: Regular dose 240 mg twice a day.
Croatian: Redovna doza 240 mg dva puta na dan
English: Not known (frequency cannot be estimated from the available data)
Croatian: - smanjenje broja krvnih pločica Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: Changes in renal laboratory tests have been seen in clinical trials in subjects treated with dimethyl fumarate (see section 4.8).
Croatian: U kliničkim ispitivanjima u ispitanika liječenih dimetilfumaratom primijećene su promjene u laboratorijskim testovima bubrega (vidjeti dio 4.8).
English: 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).
Croatian: dimetilfumarat je utjecao na fenotipove limfocita preko smanjenja profila proupalnih citokina (TH1, TH17) te je bio pristran prema protuupalnoj produkciji (TH2).
English: 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.
Croatian: Pretklinička ispitivanja pokazuju da dimetilfumarat izaziva farmakodinamičke odgovore prvenstveno aktivacijom signalnog puta nuklearnog transkripcijskog faktora Nrf2 [engl. nuclear factor
English: 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.
Croatian: Incidencija gastrointestinalnih smetnji (npr. proljev [14% u odnosu na 10%], mučnina [12% u odnosu na 9%], bol u gornjem dijelu trbuha [10% u odnosu na 6%], bol u trbuhu [9% u odnosu na 4%],
English: 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
Croatian: Mogu se javiti u više od 1 na 10 osoba: - crvenjenje lica ili tijela, osjećaj topline, vrućine, žarenja ili svrbeža (navala crvenila) - mekane stolice (proljev)
English: Effects on the immune system In preclinical and clinical studies, dimethyl fumarate demonstrated anti-inflammatory and immunomodulatory properties.
Croatian: U pretkliničkim i kliničkim ispitivanjima dimetilfumarat je pokazao protuupalna i imunomodulacijska svojstva.
English: Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg' containing microtablets.
Croatian: Zelene tvrde želučanootporne kapsule, veličine 0, s otisnutom oznakom „BG-12 240 mg“, koje sadrže mikrotablete.
English: The majority of cases were non-serious, however, serious cases, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster oticus, herpes zoster infection neurological, herpes zoster meningoencephalitis and herpes zoster meningomyelitis have been reported.
Croatian: očni herpes zoster, ušni herpes zoster, herpes zoster infekciju neurološkog sustava, meningoencefalitis uzrokovan herpes zosterom te meningomijelitis uzrokovan herpes zosterom.
English: Evidence from healthy volunteer studies suggests that Tecfidera-associated flushing is likely to be prostaglandin mediated.
Croatian: Dokazi iz ispitivanja sa zdravim dobrovoljcima ukazuju na to da je navala crvenila povezana s Tecfiderom najvjerojatnije posredovana prostaglandinima.
English: PML has occurred in the setting of moderate to severe prolonged lymphopenia (see section 4.4).
Croatian: PML se pojavio u uvjetima umjerene do teške i produljene limfopenije (vidjeti dio 4.4).
English: Gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience gastrointestinal events, these events may continue to occur intermittently throughout treatment with Tecfidera.
Croatian: Gastrointestinalne smetnje imaju tendenciju pojave rano u tijeku liječenja (prvenstveno u prvom mjesecu) i u bolesnika s gastrointestinalnim smetnjama, te su se smetnje ponekad isprekidano ponavljale i tijekom daljnjeg liječenja Tecfiderom.
English: 56 gastro-resistant hard capsules 168 gastro-resistant hard capsules
Croatian: 56 tvrdih želučanootpornih kapsula 168 tvrdih želučanootpornih kapsula
English: 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).
Croatian: Peroralna primjena dimetilfumarata u mužjaka štakora od 75, 250 i 375 mg/kg/dan prije i za vrijeme parenja nije imala utjecaja na mušku plodnost do najviše testirane doze (najmanje 2 puta veće od preporučene doze na temelju AUC-a).
English: Tecfidera should not be used during breast-feeding.
Croatian: Tecfideru se ne smije uzimati dok dojite.
English: The forestomach in rodents does not have a human counterpart.
Croatian: Predželudac u glodavaca nema ekvivalenta u ljudi.
English:  Stop taking Tecfidera and call a doctor straight away Very common side effects
Croatian: Prekinite uzimanje Tecfidere i javite se odmah liječniku.
English: 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.
Croatian: U placebom kontroliranim ispitivanjima, incidencija navale crvenila (34% u odnosu na 4%) odnosno navale vrućine (7% u odnosu na 2%) bila je povećana u bolesnika liječenih Tecfiderom u usporedbi s placebom.
English: Renal tubule epithelial regeneration, suggestive of injury, was observed in all species.
Croatian: U svih vrsta životinja primijećena je regeneracija bubrežnog tubularnog epitela, što upućuje na pojavu ozljede.
English: Dimethyl fumarate was negative in the in vivo micronucleus assay in the rat.
Croatian: Dimetilfumarat je bio negativan u in vivo mikronukleusnom testu u štakora.
English: The median number of new or newly enlarging T2 hyperintense lesions changed from 2 in the 8 week pre-treatment evaluation period to 0 in the final 8 weeks of the treatment period (median change -2, n=16).
Croatian: 2 u 8-tjednom razdoblju procjene prije liječenja na 0 u zadnjih 8 tjedana terapijskog razdoblja
English: In Study 2, patients had the following median baseline characteristics: age 37 years, disease duration 6.0 years, EDSS score 2.5.
Croatian: starost 37 godina, trajanje bolesti 6,0 godina i EDSS bodova 2,5.
English: Tecfidera has not been studied in patients with severe active gastrointestinal disease and caution should, therefore, be used in these patients.
Croatian: Tecfidera nije ispitivana u bolesnika s teškom aktivnom bolešću probavnog sustava pa je potreban oprez pri liječenju takvih bolesnika.
English: In Study 1, patients had the following median baseline characteristics: age 39 years, disease duration 7.0 years, EDSS score 2.0.
Croatian: starost 39 godina, trajanje bolesti 7,0 godina, EDSS bodovi 2,0.
English: Tηλ: +30 210 8771500
Croatian: Genesis Pharma SA Tηλ: +30 210 8771500
English: MedDRA System Organ Class Adverse reaction
Croatian: MedDRA klasifikacija organskih sustava
English: Data from healthy volunteer studies suggest that dimethyl fumarate-associated flushing is likely to be prostaglandin mediated.
Croatian: Podaci iz ispitivanja sa zdravim dobrovoljcima ukazuju na to da je navala crvenila povezana s dimetilfumaratom najvjerojatnije posredovana prostaglandinima.