natgillin/translations-raw huggingface dataset:
Commonly used medicinal products in patients with multiple sclerosis, intramuscular interferon beta-1a and glatiramer acetate, were clinically tested for potential interactions with dimethyl fumarate and did not alter the pharmacokinetic profile of dimethyl fumarate. 
Zdravili, ki se pri bolnikih z multiplo sklerozo pogosto uporabljata, intramuskularni interferon beta-1a in glatiramer acetat, so klinično preskusili glede možnih medsebojnih delovanj z dimetilfumaratom; spremembe farmakokinetičnega profila dimetilfumarata niso ugotovili.
If therapy is continued in the presence of moderate to severe prolonged lymphopenia, the risk of an opportunistic infection, including PML, cannot be ruled out (see section 4.4 subsection PML). 
Če se zdravljenje v primeru zmerne do hude dolgotrajne limfopenije nadaljuje, ni mogoče izključiti tveganja oportunistične okužbe, vključno s PML (glejte poglavje 4.4,
Most subjects, including those who experienced a serious herpes zoster infection, had lymphocyte counts above the lower limit of normal. 
Pri večini preiskovancev, tudi tistih z resno okužbo s herpesom zostrom, je bilo število limfocitov nad spodnjo mejo normale.
After starting therapy, complete blood counts, including lymphocytes, must be performed every 3 months. 
Po začetku zdravljenja je treba vsake 3 mesece izvesti preiskavo celotne krvne slike, vključno z limfociti.
Clinical factors, evaluation of any laboratory and imaging investigations could be included as part of this reconsideration. 
ta ponovni razmislek je mogoče vključiti klinične dejavnike ter ocene morebitnih laboratorijskih in slikovnih preiskav.
 Taking your medicine with food can help to reduce the side effects above 
- trebušna bolečina ali krči  Jemanje zdravila s hrano lahko pomaga zmanjšati zgoraj navedene neželene učinke
The increased incidence of elevations of hepatic transaminases in patients treated with Tecfidera relative to placebo was primarily seen during the first 6 months of treatment. 
Večja incidenca zvišanj jetrnih transaminaz pri bolnikih, zdravljenih z zdravilom Tecfidera, v primerjavi s tistimi, zdravljenimi s placebom, je bila opazna predvsem prvih 6 mesecev zdravljenja.
- medicines that affect the kidneys including some antibiotics (used to treat infections), “water tablets” (diuretics), certain types of painkillers (such as ibuprofen and other similar antiinflammatories and medicines purchased without a doctor's prescription) and medicines that contain lithium - Taking Tecfidera with certain types of vaccines (live vaccines) may cause you to get an infection and should, therefore, be avoided. 
- zdravila, ki vplivajo na ledvice, vključno z nekaterimi antibiotiki (uporabljajo se za zdravljenje okužb), tablete za odvajanje vode (diuretiki), nekatere vrste zdravil proti bolečini (kot je ibuprofen in druga podobna protivnetna zdravila in zdravila, ki jih kupite brez zdravniškega recepta) in zdravila, ki vsebujejo litij
What Tecfidera is used for Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients. 
Zdravilo Tecfidera se uporablja za zdravljenje recidivno-remitentne multiple skleroze (MS) pri odraslih bolnikih.
240 mg capsules: 56 or 168 capsules in PVC/PE/PVDC-PVC aluminium blister packs. 
240 mg kapsule: 56 ali 168 kapsul v pretisnih omotih PVC/PE/PVDC-PVC-aluminij.
In a small 24-week open-label uncontrolled study in paediatric patients with RRMS aged 13 to 17 years (120 mg twice a day for 7 days followed by 240 mg twice a day for the remainder of treatment; safety population, n=22), followed by a 96 week extension study (240mg twice per day ; safety population n=20), the safety profile appeared similar to that observed in adult patients. 
V majhni 24-tedenski odprti nekontrolirani študiji pri otrocih z RRMS, starih od 13 do 17 let (120 mg dvakrat na dan 7 dni, nato 240 mg dvakrat na dan preostali čas zdravljenja; populacija za oceno varnosti, n=22), kateri je sledila 96-tedenska podaljšana študija (240 mg dvakrat na dan; populacija za oceno varnosti, n=20), je bil varnostni profil podoben kot pri odraslih bolnikih.
The incidence of serious gastrointestinal events, including gastroenteritis and gastritis, was seen in 1% of patients treated with Tecfidera (see section 4.2). 
Incidenca resnih prebavnih dogodkov, vključno z gastroenteritisom in gastritisom, se je pojavila pri 1 % bolnikov, zdravljenih z zdravilom Tecfidera (glejte poglavje 4.2).
Potassium hydroxide Black iron oxide (E172) 
šelak kalijev hidroksid črni železov oksid (E172)
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. 
Poleg tega je imelo 17 % bolnikov rezultat po EDSS > 3,5, 32 % jih je imelo ≥ 2 recidiva v predhodnem letu in 30 % se jih je predhodno zdravilo z drugimi odobrenimi oblikami zdravljenja MS.
There are no data on the effects of dimethyl fumarate on human fertility. 
Ni podatkov o vplivu dimetilfumarata na plodnost pri ljudeh.
What Tecfidera is and what it is used for What you need to know before you take Tecfidera How to take Tecfidera 
Kaj je zdravilo Tecfidera in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tecfidera Kako jemati zdravilo Tecfidera
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. 
Ker sta zgodnje diagnosticiranje Fanconijevega sindroma in prekinitev zdravljenja z zdravilom, ki je možen vzrok za ta sindrom, npr. dimetilfumarata, pomembna za preprečevanje pojava ledvične okvare in osteomalacije, odbor PRAC priporoča, da se v poglavje 4.4 Povzetka glavnih značilnosti zdravila doda opozorilo, ki bo zdravnike opozarjalo na morebitna tveganja za pojav Fanconijevega sindroma, skupaj z opisom pripadajočih simptomov.
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. 
Poleg tega je imelo 16 % bolnikov rezultat po EDSS > 3,5, 28 % jih je imelo ≥ 2 recidiva v predhodnem letu in 42 % se jih je predhodno zdravilo z drugimi odobrenimi oblikami zdravljenja MS.
No studies on the ability to drive and use machines have been conducted but no effects potentially influencing this ability were found to be related to dimethyl fumarate in clinical studies. 
Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli, vendar v kliničnih študijah niso ugotovili učinkov, povezanih z dimetilfumaratom, ki bi lahko vplivali na to sposobnost.
A complete blood count is recommended prior to initiating Tecfidera and regularly during treatment (see Blood/laboratory tests above). 
Pred začetkom zdravljenja z zdravilom Tecfidera je priporočljivo izvesti preiskavo celotne krvne slike, ki jo je treba izvajati tudi redno med zdravljenjem (glejte podpoglavje Krvni/laboratorijski testi zgoraj).
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. 
Zvišanja alanin aminotransferaze in aspartat aminotransferaze, ≥ 3-krat ULN, so opazili pri 5 % oz. 2 % bolnikov, zdravljenih s placebom, in 6 % oz. 2 % bolnikov, zdravljenih z zdravilom Tecfidera.
Dimethyl fumarate was administered orally at doses of 25, 75, 200 and 400 mg/kg/day in mice, and at doses of 25, 50, 100, and 150 mg/kg/day in rats. 
Dimetilfumarat so peroralno dajali mišim v odmerkih 25, 75, 200 in 400 mg/kg/dan in v odmerkih 25, 50, 100 in
120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs. 
120 mg kapsule: 14 kapsul v pretisnih omotih PVC/PE/PVDC-PVC-aluminij.
The findings were observed at approximately the recommended dose in rats and 3 times the recommended dose in dogs (AUC basis). 
Te izsledke so opazili pri približno priporočenem odmerku pri podganah in pri 3-kratniku priporočenega odmerka pri psih (na osnovi AUC).
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. 
4.2 Odmerjanje in način uporabe Zdravljenje naj se začne pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem multiple skleroze.
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 je, da dimetilfumarat pri bolnikih zvišuje antioksidativne gene, odvisne od Nrf2 (npr. NAD(P)H dehidrogenaza, kinon 1; [NQO1]).
Tecfidera should not be used during breast-feeding. 
Zdravila Tecfidera ne uporabljajte med dojenjem.
Interstitial fibrosis and cortical atrophy were observed at 6 times the recommended dose based on AUC. 
Fibrozo intersticija in kortikalno atrofijo so opazili pri 6-kratniku priporočenega odmerka na osnovi AUC.
Discontinuations due to elevated hepatic transaminases were <1% and similar in patients treated with Tecfidera or placebo. 
Prekinitev zdravljenja zaradi zvišanja jetrnih transaminaz je bila < 1 % in podobna pri bolnikih, zdravljenih z zdravilom Tecfidera ali s placebom.
The chronic dog study was conducted with oral administration of the dimethyl fumarate capsule. 
Kronično študijo pri psih so izvedli s peroralnim dajanjem kapsul dimetilfumarata.
Orally administered dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its primary metabolite, monomethyl fumarate, which is also active. 
Peroralno uporabljen dimetilfumarat je predmet hitre predsistemske hidrolize z esterazami, kjer se pretvori v svoj najpomembnejši presnovek, monometil fumarat, ki je prav tako aktiven.
Before initiating treatment with Tecfidera, a baseline MRI should be available (usually within 3 months) as a reference. 
Pred začetkom zdravljenja z zdravilom Tecfidera naj bi bilo za referenco na voljo izhodiščno slikanje z MR (običajno opravljeno v obdobju 3 mesecev).
Patients receiving Tecfidera should be instructed to report symptoms of infections to a physician. 
Tecfidera, je treba naročiti, da zdravniku poročajo o simptomih okužb.
Adverse reactions, which were more frequently reported in Tecfidera versus placebo-treated patients, are presented in the table below. 
Neželeni učinki, pogosteje poročani z zdravilom Tecfidera kot pri bolnikih, zdravljenih s placebom, so predstavljeni v spodnji preglednici.
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. 
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).
The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia). 
glukozurija (z normalnimi ravnmi sladkorja v krvi), hiperaminoacidurija in fosfaturija (po možnosti sočasno s hipofosfatemijo).
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. 
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.
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. 
Tecfidera prejelo skupaj 2.468 bolnikov, ki so jih spremljali do 4 leta, s celokupnim ekvivalentom izpostavljenosti 3.588 oseb-let.
In subjects with multiple sclerosis, two 240 mg doses were administered 4 hours apart as part of a three times a day dosing regimen. 
V študijah so bolniki z multiplo sklerozo v 4-urnih časovnih razmikih prejeli dva 240 mg odmerka kot del režima odmerjanja trikrat na dan.
Tecfidera should be taken with food (see section 5.2). 
Zdravilo Tecfidera se jemlje s hrano (glejte poglavje 5.2).
Four per cent (4%) of patients treated with Tecfidera discontinued due to gastrointestinal events. 
Štirje odstotki (4 %) bolnikov, zdravljenih z zdravilom Tecfidera, so se zaradi prebavnih dogodkov prenehali zdraviti.
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). 
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).
Subjects received Tecfidera 120 mg twice a day for 7 days followed by 240 mg twice a day for 24 weeks. 
Tecfidera v odmerku 120 mg dvakrat na dan 7 dni, nato pa 240 mg dvakrat na dan 24 tednov.
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. 
Ker dimetilfumarat in monometil fumarat presnavljajo esteraze brez udeležbe sistema CYP450, ocene farmakokinetike pri posameznikih z okvaro jeter niso izvedli.
Gender and age did not have a clinically significant impact on the pharmacokinetics of dimethyl fumarate. 
Spol in starost nista klinično pomembno vplivala na farmakokinetiko dimetilfumarata.
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. 
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.
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. 
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+).
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. 
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.
Angioedema1 
neznana angioedem1
You may take the missed dose if you leave at least 4 hours between the doses. 
Izpuščeni odmerek lahko vzamete, če so do naslednjega odmerka še vsaj 4 ure.
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. 
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.
Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4). 
Previdnost je potrebna pri zdravljenju bolnikov s hudo ledvično ali hudo jetrno okvaro (glejte poglavje 4.4).
Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly. 
Na podlagi načina delovanja učinkovine ni teoretičnih razlogov, ki bi narekovali zmanjšanje odmerka za starejše bolnike.
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. 
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.
Prior to initiating treatment with Tecfidera, a current complete blood count, including lymphocytes, must be performed. 
Pred uvedbo zdravljenja z zdravilom Tecfidera je treba izvesti preiskavo celotne krvne slike, vključno z limfociti.
The benefit/risk balance of the therapy should be reconsidered in discussion with the patient in the context of other therapeutic options available. 
V pogovoru z bolnikom je treba ponovno pretehtati razmerje med koristmi in tveganjem zdravljenja glede na druge možnosti zdravljenja, ki so na voljo.
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). 
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).
The downstream metabolism of fumaric acid occurs through the tricarboxylic acid cycle, with exhalation of CO2 serving as a primary route of elimination. 
Presnova fumarne kisline poteka v ciklu trikarboksilne kisline, glavno pot izločanja pa je izdihovanje CO2.
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. 
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.
Dimethyl fumarate and mono-methylfumarate were negative in a battery of in vitro assays (Ames, chromosomal aberration in mammalian cells). 
Dimetilfumarat in monometilfumarat sta bila negativna v nizu preskusov in vitro (Ames, kromosomska aberacija celic sesalcev).
Tecfidera has no or negligible influence on the ability to drive and use machines. 
Zdravilo Tecfidera nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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. 
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,
Limited data is available on ALC in patients with herpes zoster infection in the post-marketing setting. 
Pri bolnikih, okuženih s herpesom zostrom, so iz obdobja trženja na voljo omejeni podatki glede ALC.
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). 
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),
The capsule should be swallowed whole. 
Način uporabe peroralna uporaba Kapsulo je treba pogoltniti celo.
The symptoms of PML may be similar to an MS relapse. 
Simptomi PML so lahko podobni simptomom recidiva multiple skleroze.
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). 
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).
Tecfidera has not been studied in patients with renal or hepatic impairment. 
Zdravila Tecfidera niso preučili pri bolnikih z okvaro ledvic ali jeter.
Gastro-resistant hard capsule 
gastrorezistentna trda kapsula
Herpes zoster infections 
Okužbe s herpesom zostrom
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. 
V študiji in vivo sočasno dajanje zdravila Tecfidera s kombiniranim peroralnim kontraceptivom (norgestimat in etinilestradiol) ni povzročilo pomembnih sprememb v izpostavljenosti peroralnemu kontraceptivu.
In case of clinical suspicion of PML, MRI should be performed immediately for diagnostic purposes. 
Če obstaja klinični sum na PML, je treba v diagnostične namene slikanje z MR izvesti takoj.
Further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system. 
Nadalje se presnovi v ciklu trikarboksilne kisline, brez sodelovanja sistema citokroma P450 (CYP).
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). 
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).
In the placebo-controlled studies, measurement of urinary ketones (1+ or greater) was higher in patients treated with Tecfidera (45%) compared to placebo (10%). 
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 %).
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. 
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.
Monitor patients taking Tecfidera for signs and symptoms of herpes zoster especially when concurrent lymphocytopenia is reported. 
Bolnike, ki jemljejo zdravilo Tecfidera, spremljajte glede znakov in simptomov herpesa zostra, zlasti če obstajajo poročila o sočasni limfocitopeniji.