FrancophonIA/ELRC3.0 huggingface dataset:
English: - herpes zoster (shingles) with symptoms such as blisters, burning, itching or pain of the skin, typically on one side of the upper body or the face, and other symptoms, like fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
Slovenian: - herpes zoster (pasovec) s simptomi, kot so mehurčki, pekoč občutek, srbenje ali boleča koža, tipično na eni strani zgornjega dela telesa ali obraza, in drugi simptomi, kot so povišana telesna temperatura in šibkost v zgodnjih fazah okužbe, čemur sledi otopelost, srbenje ali rdeči madeži s hudo bolečino
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.
Slovenian: V celotnem obdobju zdravljenja (120 tednov) je bila letna stopnja recidivov 0,2, kar pomeni 84,5% relativno zmanjšanje deleža recidivov (n=20; 95-% IZ [66,8; 92,8], p < 0,0001), v primerjavi z letom pred začetkom zdravljenja.
English: In rare cases hypophosphataemic osteomalacia with nonlocalised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur.
Slovenian: V redkih primerih hipofosfatemične osteomalacije z nelokalizirano bolečino v kosteh se lahko pojavijo zvišane ravni alkalne fosfataze v serumu in stresni zlomi.
English: Based on data from placebo-controlled studies, the majority of patients with elevations had hepatic transaminases that were <3 times the upper limit of normal (ULN).
Slovenian: Na podlagi podatkov iz študij, kontroliranih s placebom, je imela večina bolnikov z zvišanji jetrne transaminaze, < 3-krat višje od zgornje normalne vrednosti (ULN).
English: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.
Slovenian: Prehodno zvečanje povprečnega števila eozinofilcev so ugotavljali v prvih 2 mesecih zdravljenja.
English: If lymphocyte count is found to be below the normal range, thorough assessment of possible causes should be completed prior to initiation of treatment with Tecfidera.
Slovenian: Če je ugotovljeno, da je število limfocitov pod normalno vrednostjo, je treba pred začetkom zdravljenja z zdravilom Tecfidera podrobno oceniti možne vzroke.
English: The lower offspring body weight was considered secondary to maternal toxicity.
Slovenian: Nižjo telesno maso potomcev so pripisali toksičnosti za mater.
English: Reddening of the face or body (flushing) is a very common side effect.
Slovenian: Rdečina obraza ali telesa (vročinsko oblivanje) je zelo pogost neželeni učinek.
English: If herpes zoster occurs, appropriate treatment for herpes zoster should be administered.
Slovenian: Če se pojavi herpes zoster, je treba uvesti ustrezno zdravljenje za herpes zoster.
English: Based on clinical pharmacology studies, no dose adjustments are needed (see section 5.2).
Slovenian: Na podlagi kliničnih farmakoloških študij prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Tecfidera may affect your white blood cell counts, your kidneys and liver.
Slovenian: Zdravilo Tecfidera lahko vpliva na število belih krvničk, vaše ledvice in jetra.
English: Therefore, all pharmacokinetic analyses related to dimethyl fumarate were performed with plasma monomethyl fumarate concentrations.
Slovenian: Zato so vse farmakokinetične analize za dimetilfumarat izvedli s koncentracijami monometil fumarata v plazmi.
English: At the first sign or symptom suggestive of PML, Tecfidera should be withheld and appropriate diagnostic evaluations need to be performed.
Slovenian: Ob prvem znaku ali simptomu, ki kaže na PML, je treba zadržati dajanje zdravila Tecfidera in izvesti ustrezno diagnostično vrednotenje.
English: Contents of the pack and other information What Tecfidera contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Tecfidera
English: Food does not have a clinically significant effect on exposure of dimethyl fumarate.
Slovenian: Hrana nima klinično pomembnega učinka na izpostavljenost dimetilfumaratu.
English: In vitro CYP induction studies did not demonstrate an interaction between Tecfidera and oral contraceptives.
Slovenian: Študije induciranja CYP in vitro niso pokazale medsebojnega delovanja med zdravilom Tecfidera in peroralnimi kontraceptivi.
English: Capsule print (black ink)
Slovenian: Natis na kapsuli (črno črnilo)
English: These data should be considered cautiously regarding limitations of the study design (no control arm, pre- versus post-dose comparison) (see section 4.2).
Slovenian: Na te podatke moramo gledati previdno zaradi omejitev v zasnovi študije (odsotnost kontrolne skupine, primerjava med stanjem pred odmerjanjem in po odmerjanju) (glejte poglavje 4.2).
English: In Study 1, patients had the following median baseline characteristics: age 39 years, disease duration 7.0 years, EDSS score 2.0.
Slovenian: V študiji 1 so imeli bolniki naslednje mediane vrednosti za izhodiščne karakteristike: starost 39 let, trajanje bolezni 7,0 let, rezultat po EDSS 2,0.
English: The patient may take the missed dose only if they leave 4 hours between doses.
Slovenian: Bolnik sme vzeti izpuščeni odmerek le, če so med odmerkoma minile 4 ure.
English: The pharmacokinetic profile of 240 mg dimethyl fumarate twice a day was evaluated in a small, openlabel, uncontrolled study in patients with RRMS aged 13 to 17 years (n=21).
Slovenian: Farmakokinetični profil dimetilfumarata v odmerku 240 mg dvakrat na dan so ocenjevali v majhni odprti nekontrolirani študiji pri bolnikih z RRMS, starih od 13 do 17 let (n=21).
English: Do not divide, crush, dissolve, suck or chew the capsule as this may increase some side effects.
Slovenian: Kapsule ne razpolavljajte, ne drobite, ne raztapljajte, ne sesajte in ne žvečite, saj lahko to poveča število nekaterih neželenih učinkov.
English: No clinical data are available on the efficacy and safety of live attenuated vaccines in patients taking Tecfidera.
Slovenian: Kliničnih podatkov o učinkovitosti in varnosti živih atenuiranih cepiv pri bolnikih, ki jemljejo zdravilo Tecfidera, ni na voljo.
English:  Stop taking Tecfidera and call a doctor straight away Very common side effects
Slovenian:  Takoj morate prenehati jemati zdravilo Tecfidera in poklicati zdravnika Zelo pogosti neželeni učinki
English: Flushing is usually described as flushing or hot flush, but can include other events (e.g. warmth, redness, itching, and burning sensation).
Slovenian: Vročinsko oblivanje je običajno opisano kot vročinsko oblivanje ali vročinski val, lahko pa vključuje še druge pojave (npr. občutek vročine, rdečino, srbenje in pekoč občutek).
English: Do not use Tecfidera if you are pregnant unless you have discussed this with your doctor.
Slovenian: Nosečnost Če ste noseči, ne uporabljajte zdravila Tecfidera, če se o tem niste pogovorili z zdravnikom.
English: Magnetic Resonance imaging (MRI)
Slovenian: Slikanje z magnetno resonanco (slikanje z MR)
English: Efficacy in patients with high disease activity: Consistent treatment effect on relapses in a subgroup of patients with high disease activity was observed, whilst the effect on time to 3-month sustained disability progression was not clearly established.
Slovenian: V podskupini bolnikov z zelo aktivno boleznijo so opazili učinke stalnega zdravljenja na recidive, medtem ko so učinki glede na čas pri 3-mesečnem trajnostnem napredovanju bolezni niso bili jasno dokazani.
English: In humans, dimethyl fumarate is extensively metabolised with less than 0.1% of the dose excreted as unchanged dimethyl fumarate in urine.
Slovenian: Pri ljudeh se dimetilfumarat izčrpno presnovi, pri čemer se manj kot 0,1 % odmerka izloči kot nespremenjenega dimetilfumarata s sečem.
English: The incidence of serious flushing, which may be characterised by generalised erythema, rash and/or pruritus, was seen in less than 1% of patients treated with Tecfidera (see sections 4.2, 4.4 and 4.5).
Slovenian: Incidenca resnega vročinskega oblivanja, za katerega so lahko značilni generalizirani eritem, izpuščaj in/ali pruritus, so opazili pri manj kot 1 % bolnikov, zdravljenih z zdravilom Tecfidera (glejte poglavja 4.2, 4.4 in 4.5).
English: A short course of treatment with 75 mg non-enteric coated acetylsalicylic acid may be beneficial in patients affected by intolerable flushing (see section 4.5).
Slovenian: Kratek cikel zdravljenja s 75 mg acetilsalicilne kisline brez gastrorezistentne obloge lahko pomaga bolnikom z neznosnim vročinskim oblivanjem (glejte poglavje 4.5).
English: Compared to placebo, subjects treated with Tecfidera had a clinically meaningful and statistically significant reduction on: the primary endpoint in Study 1, proportion of subjects relapsed at 2 years; and the primary endpoint in Study 2, annualised relapse rate at 2 years.
Slovenian: V primerjavi s placebom so imeli bolniki, zdravljeni z zdravilom Tecfidera, klinično pomembno in statistično značilno zmanjšanje teh 2 opazovanih dogodkov: primarni opazovani dogodek v študiji 1, delež oseb z recidivom pri 2 letih; in primarni opazovani dogodek v študiji 2, letni delež recidiva pri 2 letih.
English: On the basis of the scientific conclusions for dimethyl fumarate (multiple sclerosis) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing dimethyl fumarate (multiple sclerosis) is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za dimetilfumarat (multipla skleroza) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) dimetilfumarat (multipla skleroza) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: In the placebo-controlled studies most patients (>98%) had normal lymphocyte values prior to initiating treatment.
Slovenian: V s placebom kontroliranih študijah je imela večina bolnikov (> 98 %) pred začetkom zdravljenja normalne vrednosti limfocitov.
English: The pharmacokinetics of Tecfidera in these adolescent patients was consistent with that previously observed in adult patients (Cmax: 2.00±1.29 mg/l; AUC0-12hr: 3.62±1.16 h.mg/l, which corresponds to an overall daily AUC of 7.24 h.mg/l).
Slovenian: Farmakokinetika zdravila Tecfidera pri teh mladostniških bolnikih se je skladala s farmakokinetiko, ki so jo predhodno ugotovili pri odraslih bolnikih (Cmax: 2,00±1,29 mg/l; AUC0-12hr: 3,62±1,16 h.mg/l, kar ustreza celotni dnevni AUC 7,24 h.mg/l).
English: Small numerical differences in the response to tetanus toxoid and pneumococcal serotype 3 polysaccharide were noted in favour of non-pegylated interferon.
Slovenian: Opazili so manjše številčne razlike v odzivu na tetanusni toksoid in prevmokokni polisaharid serotipa 3 v korist nepegiliranega interferona.
English: Titanium dioxide (E171) Brilliant Blue FCF (E133) Yellow iron oxide (E172)
Slovenian: Ovoj kapsule želatina titanov dioksid (E171) briljantno modra FCF (E133) rumen železov oksid (E172)
English: Among the 10 patients with MRI data between weeks 64 and week 72 of the extension study, the median number of subjects with new or newly enlarging T2 hyperintense lesions was 0 (range 0,2).
Slovenian: Med 10 bolniki s podatki, pridobljenimi z MRS, med 64. tednom in 72. tednom podaljšane študije je bilo mediano število novih ali na novo zvečanih T2 hiperintenzivnih lezij 0 (razpon 0,2).
English: Symptoms may include dyspnoea, hypoxia, hypotension, angioedema, rash or urticaria.
Slovenian: Simptomi lahko obsegajo dispnejo, hipoksijo, hipotenzijo, angioedem, izpuščaj ali urtikarijo.
English: Assessment of serum aminotransferases (e.g. alanine aminotransferase (ALT), aspartate aminotransferase (AST)) and total bilirubin levels are recommended prior to treatment initiation and during treatment as clinically indicated.
Slovenian: Določanje aktivnosti serumskih aminotransferaz (npr. alanin aminotransferaze (ALT), aspartat aminotransferaze (AST)) in koncentracije celotnega bilirubina je priporočljivo pred začetkom zdravljenja in tudi med zdravljenjem, če je to klinično indicirano.
English: These data were derived from 2 pivotal Phase 3 placebo-controlled, double-blind clinical trials with a total of 1,529 patients treated with Tecfidera and for up to 24 months with an overall exposure of 2,371 person-years (see section 5.1).
Slovenian: Ti podatki so dobljeni iz 2 osrednjih, s placebom kontroliranih, dvojno slepih kliničnih preskušanj 3. faze s skupaj 1.529 bolniki, zdravljenimi z zdravilom Tecfidera do 24 mesecev, s celokupno izpostavljenostjo 2.371 oseb-let (glejte poglavje 5.1).
English: The adverse reactions described in the Toxicology and Reproduction toxicity sections below were not observed in clinical studies, but were seen in animals at exposure levels similar to clinical exposure levels.
Slovenian: Neželenih učinkov, opisanih v spodnjih poglavjih Toksikologija in Vpliv na sposobnost razmnoževanja, v kliničnih študijah niso opazili, vendar so jih opazili pri živalih s podobnimi ravnmi izpostavljenosti, kot so ravni klinične izpostavljenosti.
English: Other circulating metabolites included fumaric acid, citric acid and monomethyl fumarate.
Slovenian: Drugi presnovki v obtoku vključujejo fumarno kislino, citronsko kislino in monometil fumarat.
English: 109/L and <0.8 x 109/L for at least six months; 2% of patients experienced lymphocyte counts <0.5 x 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy.
Slovenian: 109/l in <0,8 x 109/l vsaj šest mesecev; 2 % bolnikov je imelo število limfocitov <0,5 x 109/l vsaj šest mesecev, in v tej skupini je število limfocitov ob nadaljevanju zdravljenja večinoma ostalo <0,5 x 109/l.
English: - swelling of the face, lips, mouth or tongue (angioedema) - wheezing, difficulty breathing or shortness of breath (dyspnoea, hypoxia) - dizziness or loss of consciousness (hypotension)
Slovenian: - oteklost obraza, ustnic, ust, ali jezika (angioedem), - sopenje, težave z dihanjem ali zasoplost (dispnea, hipoksija), - omotica ali izguba zavesti (hipotenzija),
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Če se zdravljenje v primeru zmerne do hude dolgotrajne limfopenije nadaljuje, ni mogoče izključiti tveganja oportunistične okužbe, vključno s PML (glejte poglavje 4.4,
English: Most subjects, including those who experienced a serious herpes zoster infection, had lymphocyte counts above the lower limit of normal.
Slovenian: Pri večini preiskovancev, tudi tistih z resno okužbo s herpesom zostrom, je bilo število limfocitov nad spodnjo mejo normale.
English: After starting therapy, complete blood counts, including lymphocytes, must be performed every 3 months.
Slovenian: Po začetku zdravljenja je treba vsake 3 mesece izvesti preiskavo celotne krvne slike, vključno z limfociti.
English: Clinical factors, evaluation of any laboratory and imaging investigations could be included as part of this reconsideration.
Slovenian: ta ponovni razmislek je mogoče vključiti klinične dejavnike ter ocene morebitnih laboratorijskih in slikovnih preiskav.
English:  Taking your medicine with food can help to reduce the side effects above
Slovenian: - trebušna bolečina ali krči  Jemanje zdravila s hrano lahko pomaga zmanjšati zgoraj navedene neželene učinke
English: 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.
Slovenian: 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.
English: - 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.
Slovenian: - 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
English: What Tecfidera is used for Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients.
Slovenian: Zdravilo Tecfidera se uporablja za zdravljenje recidivno-remitentne multiple skleroze (MS) pri odraslih bolnikih.
English: 240 mg capsules: 56 or 168 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Slovenian: 240 mg kapsule: 56 ali 168 kapsul v pretisnih omotih PVC/PE/PVDC-PVC-aluminij.
English: 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.
Slovenian: 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.
English: Mutagenesis
Slovenian: Mutageneza
English: The incidence of serious gastrointestinal events, including gastroenteritis and gastritis, was seen in 1% of patients treated with Tecfidera (see section 4.2).
Slovenian: Incidenca resnih prebavnih dogodkov, vključno z gastroenteritisom in gastritisom, se je pojavila pri 1 % bolnikov, zdravljenih z zdravilom Tecfidera (glejte poglavje 4.2).
English: Potassium hydroxide Black iron oxide (E172)
Slovenian: šelak kalijev hidroksid črni železov oksid (E172)
English: 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.
Slovenian: 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.
English: There are no data on the effects of dimethyl fumarate on human fertility.
Slovenian: Ni podatkov o vplivu dimetilfumarata na plodnost pri ljudeh.
English: What Tecfidera is and what it is used for What you need to know before you take Tecfidera How to take Tecfidera
Slovenian: Kaj je zdravilo Tecfidera in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tecfidera Kako jemati zdravilo Tecfidera
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.
Slovenian: 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.
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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: A complete blood count is recommended prior to initiating Tecfidera and regularly during treatment (see Blood/laboratory tests above).
Slovenian: 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).
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.
Slovenian: 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.
English: 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.
Slovenian: Dimetilfumarat so peroralno dajali mišim v odmerkih 25, 75, 200 in 400 mg/kg/dan in v odmerkih 25, 50, 100 in
English: 120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Slovenian: 120 mg kapsule: 14 kapsul v pretisnih omotih PVC/PE/PVDC-PVC-aluminij.
English: The findings were observed at approximately the recommended dose in rats and 3 times the recommended dose in dogs (AUC basis).
Slovenian: Te izsledke so opazili pri približno priporočenem odmerku pri podganah in pri 3-kratniku priporočenega odmerka pri psih (na osnovi AUC).
English: Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje naj se začne pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem multiple skleroze.
English: Dimethyl fumarate has been shown to up regulate Nrf2-dependent antioxidant genes in patients (e.g. NAD(P)H dehydrogenase, quinone 1; [NQO1]).
Slovenian: Pokazalo se je, da dimetilfumarat pri bolnikih zvišuje antioksidativne gene, odvisne od Nrf2 (npr. NAD(P)H dehidrogenaza, kinon 1; [NQO1]).
English: Tecfidera should not be used during breast-feeding.
Slovenian: Zdravila Tecfidera ne uporabljajte med dojenjem.
English: Interstitial fibrosis and cortical atrophy were observed at 6 times the recommended dose based on AUC.
Slovenian: Fibrozo intersticija in kortikalno atrofijo so opazili pri 6-kratniku priporočenega odmerka na osnovi AUC.
English: Discontinuations due to elevated hepatic transaminases were <1% and similar in patients treated with Tecfidera or placebo.
Slovenian: Prekinitev zdravljenja zaradi zvišanja jetrnih transaminaz je bila < 1 % in podobna pri bolnikih, zdravljenih z zdravilom Tecfidera ali s placebom.
English: The chronic dog study was conducted with oral administration of the dimethyl fumarate capsule.
Slovenian: Kronično študijo pri psih so izvedli s peroralnim dajanjem kapsul dimetilfumarata.