FrancophonIA/ELRC3.0 huggingface dataset:
English: Orally administered dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its primary metabolite, monomethyl fumarate, which is also active.
Slovenian: Peroralno uporabljen dimetilfumarat je predmet hitre predsistemske hidrolize z esterazami, kjer se pretvori v svoj najpomembnejši presnovek, monometil fumarat, ki je prav tako aktiven.
English: Before initiating treatment with Tecfidera, a baseline MRI should be available (usually within 3 months) as a reference.
Slovenian: Pred začetkom zdravljenja z zdravilom Tecfidera naj bi bilo za referenco na voljo izhodiščno slikanje z MR (običajno opravljeno v obdobju 3 mesecev).
English: Patients receiving Tecfidera should be instructed to report symptoms of infections to a physician.
Slovenian: Tecfidera, je treba naročiti, da zdravniku poročajo o simptomih okužb.
English: Adverse reactions, which were more frequently reported in Tecfidera versus placebo-treated patients, are presented in the table below.
Slovenian: Neželeni učinki, pogosteje poročani z zdravilom Tecfidera kot pri bolnikih, zdravljenih s placebom, so predstavljeni v spodnji preglednici.
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.
Slovenian: Opravili so dve 2-letni, randomizirani, dvojno slepi, s placebom kontrolirani študiji [študija 1 (DEFINE) s 1.234 osebami in študija 2 (CONFIRM) s 1.417 osebami], ki so vključevale bolnike z recidivno-remitentno multiplo sklerozo (RRMS).
English: The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
Slovenian: glukozurija (z normalnimi ravnmi sladkorja v krvi), hiperaminoacidurija in fosfaturija (po možnosti sočasno s hipofosfatemijo).
English: When switching patients from another disease modifying therapy to Tecfidera, the half-life and mode of action of the other therapy should be considered in order to avoid an additive immune effect while at the same time, reducing the risk of reactivation of MS.
Slovenian: Pri prehodu zdravljenja bolnikov z drugega zdravljenja, ki spreminja potek bolezni, na zdravljenje z zdravilom Tecfidera, je treba za preprečevanje aditivnega učinka na imunski sistem in sočasnega zmanjševanja tveganja reaktivacije MS upoštevati razpolovno dobo in način delovanja drugega zdravljenja.
English: In placebo-controlled and uncontrolled clinical studies, a total of 2,468 patients have received Tecfidera and been followed for periods up to 4 years with an overall exposure equivalent to 3,588 person-years.
Slovenian: Tecfidera prejelo skupaj 2.468 bolnikov, ki so jih spremljali do 4 leta, s celokupnim ekvivalentom izpostavljenosti 3.588 oseb-let.
English: In subjects with multiple sclerosis, two 240 mg doses were administered 4 hours apart as part of a three times a day dosing regimen.
Slovenian: V študijah so bolniki z multiplo sklerozo v 4-urnih časovnih razmikih prejeli dva 240 mg odmerka kot del režima odmerjanja trikrat na dan.
English: Tecfidera should be taken with food (see section 5.2).
Slovenian: Zdravilo Tecfidera se jemlje s hrano (glejte poglavje 5.2).
English: Four per cent (4%) of patients treated with Tecfidera discontinued due to gastrointestinal events.
Slovenian: Štirje odstotki (4 %) bolnikov, zdravljenih z zdravilom Tecfidera, so se zaradi prebavnih dogodkov prenehali zdraviti.
English: Clinical studies of Tecfidera had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients (see section 5.2).
Slovenian: majhna, in ni vključevala zadostnega števila bolnikov, starih 65 let in več, da bi ugotovili, ali se na zdravljenje odzivajo drugače kot mlajši bolniki (glejte poglavje 5.2).
English: Subjects received Tecfidera 120 mg twice a day for 7 days followed by 240 mg twice a day for 24 weeks.
Slovenian: Tecfidera v odmerku 120 mg dvakrat na dan 7 dni, nato pa 240 mg dvakrat na dan 24 tednov.
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.
Slovenian: Ker dimetilfumarat in monometil fumarat presnavljajo esteraze brez udeležbe sistema CYP450, ocene farmakokinetike pri posameznikih z okvaro jeter niso izvedli.
English: Gender and age did not have a clinically significant impact on the pharmacokinetics of dimethyl fumarate.
Slovenian: Spol in starost nista klinično pomembno vplivala na farmakokinetiko dimetilfumarata.
English: In an ongoing long-term extension study, in which 1736 MS patients are treated with Tecfidera, approximately 5% experienced one or more events of herpes zoster, the majority of which were mild to moderate in severity.
Slovenian: V tekoči dolgoročni podaljšani študiji, v okviru katere se 1736 preiskovancev z MS zdravi z zdravilom Tecfidera, se je pri približno 5 % preiskovancev vsaj enkrat pojavil herpes zoster, večina teh okužb pa je bila blaga do zmerna.
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.
Slovenian: Učinkovitost (glejte spodnjo preglednico) in varnost so dokazali pri bolnikih z razširjeno lestvico stopnje prizadetosti (EDSS, Expanded Disability Status Scale) z rezultati od 0 do vključno 5, ki so imeli vsaj 1 recidiv v letu pred randomizacijo, ali pri katerih je magnetnoresonančno slikanje (MRS), opravljeno 6 tednov pred randomizacijo, pokazalo vsaj eno lezijo, vidno z gadolinijem (Gd+).
English: Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Slovenian: Simptomi PML so lahko podobni recidivu MS. Značilni simptomi, povezani s PML, so raznoliki, se razvijajo tekom več dni ali tednov in vključujejo napredujočo šibkost ene strani telesa ali okorelost udov, motnje vida ter spremembe mišljenja, spomina in orientacije, ki povzročijo zmedenost in osebnostne spremembe.
English: Angioedema1
Slovenian: neznana angioedem1
English: You may take the missed dose if you leave at least 4 hours between the doses.
Slovenian: Izpuščeni odmerek lahko vzamete, če so do naslednjega odmerka še vsaj 4 ure.
English: In two healthy volunteer studies, the administration of 325 mg (or equivalent) non-enteric coated acetylsalicylic acid, 30 minutes prior to Tecfidera, dosing over 4 days and over 4 weeks, respectively, did not alter the pharmacokinetic profile of Tecfidera.
Slovenian: V dveh študijah na zdravih prostovoljcih je odmerjanje 325 mg (ali ustreznika) acetilsalicilne kisline brez gastrorezistentne obloge 30 minut pred uporabo zdravila Tecfidera, ki je trajalo 4 dni oziroma 4 tedne, ni spremenilo farmakokinetičnega profila zdravila Tecfidera.
English: Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4).
Slovenian: Previdnost je potrebna pri zdravljenju bolnikov s hudo ledvično ali hudo jetrno okvaro (glejte poglavje 4.4).
English: Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Slovenian: Na podlagi načina delovanja učinkovine ni teoretičnih razlogov, ki bi narekovali zmanjšanje odmerka za starejše bolnike.
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.
Slovenian: Večina teh primerov je poročala o ne-resnih neželenih učinkih, vendar pa so poročali tudi o primerih resnih neželenih učinkov, med drugim o diseminiranem herpesu zostru, oftalmičnem herpesu zostru, ušesnem herpesu zostru, nevrološki okužbi s herpesom zostrom, meningoencefalitisu zaradi herpesa zostra in meningomielitisu zaradi herpesa zostra.
English: Prior to initiating treatment with Tecfidera, a current complete blood count, including lymphocytes, must be performed.
Slovenian: Pred uvedbo zdravljenja z zdravilom Tecfidera je treba izvesti preiskavo celotne krvne slike, vključno z limfociti.
English: The benefit/risk balance of the therapy should be reconsidered in discussion with the patient in the context of other therapeutic options available.
Slovenian: V pogovoru z bolnikom je treba ponovno pretehtati razmerje med koristmi in tveganjem zdravljenja glede na druge možnosti zdravljenja, ki so na voljo.
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).
Slovenian: V kliničnih študijah pri bolnikih s psoriazo je dimetilfumarat vplival na fenotipe limfocitov z zmanjšanjem profilov provnetnih citokinov (TH1, TH17), s čimer zavira protivnetni odziv (TH2).
English: The downstream metabolism of fumaric acid occurs through the tricarboxylic acid cycle, with exhalation of CO2 serving as a primary route of elimination.
Slovenian: Presnova fumarne kisline poteka v ciklu trikarboksilne kisline, glavno pot izločanja pa je izdihovanje CO2.
English: In rats, the incidence of renal tubular carcinoma was increased at 100 mg/kg/day, approximately 2 times higher exposure than the recommended human dose.
Slovenian: Pri podganah se je incidenca karcinoma ledvičnih tubulov zvišala pri 100 mg/kg/dan, kar je približno 2-kratnik izpostavljenosti pri priporočenem odmerku pri ljudeh.
English: Dimethyl fumarate and mono-methylfumarate were negative in a battery of in vitro assays (Ames, chromosomal aberration in mammalian cells).
Slovenian: Dimetilfumarat in monometilfumarat sta bila negativna v nizu preskusov in vitro (Ames, kromosomska aberacija celic sesalcev).
English: Tecfidera has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Tecfidera nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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.
Slovenian: V študijah 3. faze pri bolnikih z MS se je po zdravljenju z zdravilom Tecfidera v prvem letu srednje število limfocitov povprečno zmanjšalo za približno 30 % izhodiščne vrednosti,
English: Limited data is available on ALC in patients with herpes zoster infection in the post-marketing setting.
Slovenian: Pri bolnikih, okuženih s herpesom zostrom, so iz obdobja trženja na voljo omejeni podatki glede ALC.
English: The other ingredients are microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, triethyl citrate, methacrylic acid - methyl methacrylate copolymer (1:1), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, simeticone, sodium laurilsulfate , polysorbate 80, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide and black iron oxide (E172).
Slovenian: Druge sestavine zdravila so: mikrokristalna celuloza, premrežen natrijev karmelozat, smukec, brezvodni koloidni silicijev dioksid, magnezijev stearat, trietil citrat, metakrilna kislina - metil metakrilat kopolimer (1:1), metakrilna kislina - etil akrilat kopolimer (1:1) disperzija 30 %, simetikon, natrijev lavrilsulfat, polisorbat 80, želatina, titanov dioksid (E171), briljantno modra FCF (E133),
English: The capsule should be swallowed whole.
Slovenian: Način uporabe peroralna uporaba Kapsulo je treba pogoltniti celo.
English: The symptoms of PML may be similar to an MS relapse.
Slovenian: Simptomi PML so lahko podobni simptomom recidiva multiple skleroze.
English: For those patients who may experience flushing or gastrointestinal adverse reactions, taking Tecfidera with food may improve tolerability (see sections 4.4, 4.5 and 4.8).
Slovenian: Za bolnike, ki imajo prebavne neželene učinke ali vročinsko oblivanje, lahko jemanje zdravila Tecfidera s hrano izboljša prenašanje (glejte poglavja 4.4, 4.5 in 4.8).
English: Tecfidera has not been studied in patients with renal or hepatic impairment.
Slovenian: Zdravila Tecfidera niso preučili pri bolnikih z okvaro ledvic ali jeter.
English: Gastro-resistant hard capsule
Slovenian: gastrorezistentna trda kapsula
English: Herpes zoster infections
Slovenian: Okužbe s herpesom zostrom
English: In an in vivo study, co-administration of Tecfidera with a combined oral contraceptive (norgestimate and ethinyl estradiol) did not elicit any relevant change in oral contraceptive exposure.
Slovenian: V študiji in vivo sočasno dajanje zdravila Tecfidera s kombiniranim peroralnim kontraceptivom (norgestimat in etinilestradiol) ni povzročilo pomembnih sprememb v izpostavljenosti peroralnemu kontraceptivu.
English: In case of clinical suspicion of PML, MRI should be performed immediately for diagnostic purposes.
Slovenian: Če obstaja klinični sum na PML, je treba v diagnostične namene slikanje z MR izvesti takoj.
English: Further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Slovenian: Nadalje se presnovi v ciklu trikarboksilne kisline, brez sodelovanja sistema citokroma P450 (CYP).
English: A rare but serious kidney disorder (Fanconi Syndrome) has been reported for a medicine containing dimethyl fumarate, in combination with other fumaric acid esters, used to treat psoriasis (a skin disease).
Slovenian: O redkem, a resnem ledvičnem obolenju (Fanconijev sindrom) so poročali v povezavi s kombinacijo zdravila, ki vsebuje dimetilfumarat in druge estre fumarne kisline in se uporablja za zdravljenje psoriaze (kožne bolezni).
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%).
Slovenian: V s placebom kontroliranih študijah so bile izmerjene vrednosti ketonov v urinu (1+ ali več) pogostejše pri bolnikih, zdravljenih z zdravilom Tecfidera (45 %), v primerjavi s placebom (10 %).
English: Upon recovery and in the absence of alternative treatment options, decisions about whether or not to restart Tecfidera after treatment discontinuation should be based on clinical judgement.
Slovenian: Če ni drugih možnosti zdravljenja, je ob okrevanju treba odločitev o tem, ali po prekinitvi dajanja zdravila Tecfidera med zdravljenjem ponovno začeti z dajanjem tega zdravila ali ne, sprejeti na podlagi klinične presoje.
English: Monitor patients taking Tecfidera for signs and symptoms of herpes zoster especially when concurrent lymphocytopenia is reported.
Slovenian: Bolnike, ki jemljejo zdravilo Tecfidera, spremljajte glede znakov in simptomov herpesa zostra, zlasti če obstajajo poročila o sočasni limfocitopeniji.
English: Cases of Fanconi syndrome have been reported for a medicinal product containing dimethyl fumarate in combination with other fumaric acid esters.
Slovenian: O primerih Fanconijevega sindroma so poročali v povezavi s kombinacijo zdravila, ki vsebuje dimetilfumarat in druge estre fumarne kisline.
English: Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients.
Slovenian: Dimetilfumarata niso preučili pri bolnikih z obstoječim nizkim številom limfocitov, zato je potrebna pri zdravljenju teh bolnikov previdnost.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The relevance of these findings to human risk is unknown.
Slovenian: Pomen teh ugotovitev za človeka ni znan.
English: 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).
Slovenian: 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.
English: The forestomach of mice and rats does not have a human counterpart.
Slovenian: Za predželodec miši in glodavcev pri ljudeh ni ustreznega organa.
English: Treatment initiation
Slovenian: Uvajanje zdravljenja
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).
Slovenian: 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).
English: This involves balancing the benefit of breast-feeding for your child, and the benefit of therapy for you.
Slovenian: To pomeni pretehtanje koristi dojenja za vašega otroka in koristi zdravljenja za vas.
English: The most commonly reported adverse reactions leading to discontinuation (incidence >1%) in patients treated with Tecfidera were flushing (3%) and gastrointestinal events (4%).
Slovenian: 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 %).
English: Talk to your doctor about how to manage these side effects.
Slovenian: O obvladovanju teh neželenih učinkov se pogovorite z zdravnikom.
English: No malformations were observed at any dose of dimethyl fumarate in rats or rabbits.
Slovenian: Pri nobenem odmerku dimetilfumarata niso opazili deformacij pri podganah ali kuncih.
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).
Slovenian: Zdravila Tecfidera niso preučili pri bolnikih s hudo okvaro ledvic ali jeter, zato je pri teh bolnikih potrebna previdnost (glejte poglavje 4.2).
English: 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).
Slovenian: 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).
English: The safety of Tecfidera in paediatric patients with multiple sclerosis below the age of 18 has not yet been established.
Slovenian: Varnost zdravila Tecfidera pri otrocih z mutliplo sklerozo, mlajših od 18 let, še ni bila dokazana.
English: 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.
Slovenian: 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.
English: In mice, the incidence of renal tubular carcinoma was increased at 75 mg/kg/day, at equivalent exposure (AUC) to the recommended human dose.
Slovenian: Pri miših se je incidenca karcinoma ledvičnih tubulov zvišala pri 75 mg/kg/dan, kar je ustreznik izpostavljenosti (AUC) pri priporočenem odmerku pri ljudeh.
English: It is not known whether the active substance of Tecfidera passes into breast milk.
Slovenian: Dojenje Ni znano, ali učinkovina zdravila Tecfidera prehaja v materino mleko.
English: Interruption of Tecfidera should be considered in patients with lymphocyte counts <0.5x109/L persisting for more than 6 months.
Slovenian: 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.
English: 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.
Slovenian: 107c(7) Direktive 2001/83/ES, in vseh poznejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Tecfidera is not expected to affect your ability to drive and use machines.
Slovenian: Ni pričakovano, da bi zdravilo Tecfidera vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: What Tecfidera looks like and contents of the pack
Slovenian: Izgled zdravila Tecfidera in vsebina pakiranja
English: There are no or limited amount of data from the use of dimethyl fumarate in pregnant women.
Slovenian: Podatkov o uporabi dimetilfumarata pri nosečnicah ni oziroma so omejeni.
English: 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.
Slovenian: 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.
English: It is initially metabolised by esterases, which are ubiquitous in the gastrointestinal tract, blood and tissues, before it reaches the systemic circulation.
Slovenian: Preden doseže sistemski obtok, ga presnovijo esteraze, ki so v prebavilih, krvi in tkivu prisotne povsod.
English: Dimethyl fumarate demonstrated therapeutic activity in multiple models of inflammatory and neuroinflammatory injury.
Slovenian: Dimetilfumarat kaže terapevtski učinek pri več modelih vnetnih in nevrovnetnih poškodb.
English: The starting dose is 120 mg twice a day.
Slovenian: Začetni odmerek je 120 mg dvakrat na dan.
English: Tecfidera has not been studied in combination with anti-neoplastic or immunosuppressive therapies and caution should, therefore, be used during concomitant administration.
Slovenian: Zdravila Tecfidera niso preučili v kombinaciji z zdravili proti novotvorbam ali imunosupresivi, zato je potrebna pri sočasni uporabi s temi zdravili previdnost.
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.
Slovenian: 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.