natgillin/translations-raw huggingface dataset:
The patient may take the missed dose only if they leave 4 hours between doses. 
Bolesnik smije uzeti propuštenu dozu samo ako je između doza proteklo 4 sata.
Patients should be instructed to discontinue Tecfidera and seek immediate medical care if they experience signs or symptoms of anaphylaxis. 
Bolesnicima se mora savjetovati da prekinu uzimati Tecfideru i potraže hitnu medicinsku pomoć ako osjete znakove ili simptome anafilaksije.
Other circulating metabolites included fumaric acid, citric acid and monomethyl fumarate. 
Drugi cirkulirajući metaboliti uključuju fumaratnu kiselinu, citratnu kiselinu i monometilfumarat.
How Tecfidera works 
Kako Tecfidera radi
However, due to Tecfidera immunomodulatory properties (see section 5.1), if a patient develops a serious infection, suspending treatment with Tecfidera should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy. 
zbog imunomodulatornih svojstava Tecfidere (vidjeti dio 5.1), ako bolesnik razvije ozbiljnu infekciju potrebno je razmotriti privremeni prekid liječenja Tecfiderom i ponovno procijeniti omjer koristi i rizika prije ponovnog uvođenja terapije.
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. 
Prikazano je da dimetilfumarat prelazi kroz membranu placente u krv fetusa u štakora i kunića, s omjerima plazmatske koncentracije u fetusu prema majci 0,48 do 0,64 odnosno 0,1.
The downstream metabolism of fumaric acid occurs through the tricarboxylic acid cycle, with exhalation of CO2 serving as a primary route of elimination. 
Nizvodni metabolizam fumaratne kiseline se zbiva kroz ciklus trikarboksilatne kiseline, tako da je izdisanje CO2 glavni put eliminacije.
Reddening of the face or body (flushing) is a very common side effect. 
Crvenjenje lica ili tijela (navala crvenila) vrlo je česta nuspojava.
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 je primijenjen peroralno u dozama u od 25, 75, 200 i 400 mg/kg/dan u miševa, a pri dozama od 25, 50, 100 i 150 mg/kg/dan u štakora.
- Very rare (<1/10,000) - Not known (frequency cannot be estimated from the available data) 
- rijetko (≥1/10 000 i <1/1000) - vrlo rijetko (<1/10 000) - nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
A single 240 mg 14C-dimethyl fumarate dose study identified glucose as the predominant metabolite in human plasma. 
Ispitivanje jednokratnom dozom od 240 mg 14C-dimetilfumarata je pokazalo da je glukoza predominantni metabolit u ljudskoj plazmi.
The frequencies described in the table below are based on 769 patients treated with Tecfidera 240 mg twice a day and 771 patients treated with placebo 
Učestalosti opisane u tablici u nastavku temelje se na 769 bolesnika liječenih Tecfiderom 240 mg dva puta dnevno i 771 bolesnika koji su dobivali placebo.
The relevance of these findings to human risk is unknown. 
Nije poznata relevantnost ovih nalaza za rizik u ljudi.
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). 
Farmakokinetika Tecfidere u ovih adolescentnih bolesnika bila je sukladna onoj prethodno opaženoj u odraslih bolesnika (Cmax: 2,00±1,29 mg/l; AUC0-12hr: 3,62±1,16 h.mg/l, što odgovara ukupnom dnevnom AUC-u od 7,24 h.mg/l).
Flushing is usually described as flushing or hot flush, but can include other events (e.g. warmth, redness, itching, and burning sensation). 
Navala crvenila je obično opisana kao navala crvenila ili navala vrućine, ali može uključiti druge promjene (npr. toplinu, crvenilo, svrbež i osjećaj žarenja).
120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs. 
Kapsule od 120 mg: 14 kapsula u PVC/PE/PVDC-PVC aluminijskim blister pakiranjima.
Therefore, all pharmacokinetic analyses related to dimethyl fumarate were performed with plasma monomethyl fumarate concentrations. 
Prema tome, sve farmakokinetičke analize u odnosu na dimetilfumarat su obavljene s koncentracijama monometilfumarata u plazmi.
Before initiating treatment with Tecfidera, a baseline MRI should be available (usually within 3 months) as a reference. 
Prije početka liječenja Tecfiderom, treba biti na raspolaganju početni MR nalaz (napravljen obično unutar 3 mjeseca), kao referentni nalaz.
Mean and median lymphocyte counts remained within normal limits. 
Srednja vrijednost broja limfocita i medijan ostali su u granicama normale.
Subjects received Tecfidera 120 mg twice a day for 7 days followed by 240 mg twice a day for 24 weeks. 
Ispitanici su primali Tecfideru u dozi od 120 mg dvaput na dan tijekom 7 dana te potom 240 mg dvaput na dan tijekom 24 tjedna.
On average, lymphocyte counts decreased by approximately 30% of baseline value. 
U prosjeku se broj limfocita smanjio otprilike za 30% od početne vrijednosti.
DK-3400 Hillerod 
DK-3400 Hillerød
At the first sign or symptom suggestive of PML, Tecfidera should be withheld and appropriate diagnostic evaluations need to be performed. 
Kod prvog znaka ili simptoma koji ukazuje na PML, primjenu Tecfidere treba prekinuti te provesti odgovarajuće dijagnostičke procjene.
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. 
Uobičajeno korišteni lijekovi u bolesnika s multiplom sklerozom, intramuskularni interferon beta-1a i glatirameracetat, klinički su ispitani na potencijalne interakcije s dimetilfumaratom i pokazalo se da nisu promijenili farmakokinetički profil dimetilfumarata.
A transient increase in mean eosinophil counts was seen during the first 2 months of therapy. 
Prolazno povišenje srednje vrijednosti broja eozinofila zabilježeno je tijekom prva 2 mjeseca terapije.
Orally administered dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its primary metabolite, monomethyl fumarate, which is also active. 
Peroralno primijenjeni dimetilfumarat prolazi brzu predsistemsku hidrolizu pomoću esteraza i pretvara se u svoj primarni metabolit, monometilfumarat, koji je također aktivan.
240 mg capsules: 56 or 168 capsules in PVC/PE/PVDC-PVC aluminium blister packs. 
Kapsule od 240 mg: 56 ili 168 kapsula u PVC/PE/PVDC-PVC aluminijskim blister pakiranjima.
These data should be considered cautiously regarding limitations of the study design (no control arm, pre- versus post-dose comparison) (see section 4.2). 
Ove je podatke potrebno oprezno razmotriti s obzirom na ograničenja dizajna ispitivanja (nije bilo kontrolne skupine ni usporedbe prije naspram poslije doze) (vidjeti dio 4.2).
In clinical trials, 3 patients out of a total of 2,560 patients treated with dimethyl fumarate experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions. 
U kliničkim ispitivanjima 3 od ukupno 2560 bolesnika liječenih dimetilfumaratom imala su ozbiljne simptome navale crvenila, koje su vjerojatno bile reakcije preosjetljivosti ili anafilaktoidne reakcije.
Tecfidera seems to work by stopping the body's defence system from damaging your brain and spinal cord. 
Čini se da Tecfidera djeluje zaustavljajući oštećenja mozga i leđne moždine izazvana djelovanjem obrambenog sustava tijela.
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. 
Kod prelaska bolesnika s druge terapije koja modificira tijek bolesti na Tecfideru, treba uzeti u obzir poluvijek i način djelovanja druge terapije kako bi se izbjegao aditivni imunološki učinak uz istovremeno smanjenje rizika od reaktivacije MS-a.
If JCV testing is undertaken, it should be considered that the influence of lymphopenia on the accuracy of anti-JCV antibody test has not been studied in dimethyl fumarate treated patients. 
Ako je provedeno JCV testiranje, treba uzeti u obzir da utjecaj limfopenije na točnost testa na anti-JCV protutijela nije ispitana u bolesnika koji se liječe dimetilfumaratom.
Capsule contents (enteric-coated microtablets) 
Sadržaj kapsule (acidorezistentne mikrotablete)
Early diagnosis of Fanconi syndrome and discontinuation of dimethyl fumarate treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible. 
Rano dijagnosticiranje Fanconijeva sindroma i prekid liječenja dimetilfumaratom važni su za sprječavanje nastanka oštećenja bubrega i osteomalacije, jer je ovaj sindrom obično reverzibilan.
Dimethyl fumarate is not quantifiable in plasma following oral administration of Tecfidera. 
Dimetilfumarat se ne može kvantificirati u plazmi nakon peroralne primjene Tecfidere.
Concurrent therapy with nephrotoxic medicinal products (such as aminoglycosides, diuretics, nonsteroidal anti-inflammatory drugs or lithium) may increase the potential of renal adverse reactions (e.g. proteinuria see section 4.8) in patients taking Tecfidera (see section 4.4 Blood/laboratory tests). 
Istodobna terapija s nefrotoksičnim lijekovima (kao što su aminoglikozidi, diuretici, nesteroidni protuupalni lijekovi ili litij) može povećati mogućnost bubrežnih nuspojava (npr. proteinurije, vidjeti dio 4.8) u bolesnika koji uzimaju Tecfideru (vidjeti dio 4.4 Krvni/laboratorijski testovi).
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). 
Drugi sastojci su mikrokristalična celuloza, umrežena karmelozanatrij, talk, silicijev dioksid, koloidni bezvodni, magnezijev stearat, trietilcitrat, metakrilatna kiselina - metilmetakrilat kopolimer (1:1), metakrilatna kiselina - etilakrilat kopolimer (1:1) 30% disperzija, simetikon, natrijev laurilsulfat, polisorbat 80, želatina, titanijev dioksid (E171), brilliant blue FCF (E133), žuti željezov oksid (E172), šelak, kalijev hidroksid i crni željezov oksid (E172).
Food does not have a clinically significant effect on exposure of dimethyl fumarate. 
Hrana nema klinički značajan učinak na izloženost dimetilfumaratu.
In case of unclear symptoms Fanconi syndrome should be considered and appropriate examinations should be performed. 
U slučaju pojave nejasnih simptoma, potrebno je uzeti u obzir Fanconijev sindrom te provesti odgovarajuće pretrage.
Study 2 contained a rater-blinded (i.e. study physician/ investigator assessing the response to study treatment was blinded) reference comparator of glatiramer acetate. 
Ispitivanje 2 bilo je slijepo za ocjenjivača (tj. liječnik/ispitivač koji procjenjuje odgovor na liječenje u ispitivanju ne zna koju tvar uzima ispitanik) i uključivalo je za usporedbu referentni lijek glatirameracetat.
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. 
Zabilježen je dosljedan učinak liječenja relapsa u podskupini bolesnika s visokom aktivnošću bolesti, dok učinak u vremenu do 3 mjeseca kontinuiranog napredovanja onesposobljenosti nije jasno utvrđen.
Exhalation of CO2 is the primary route of dimethyl fumarate elimination accounting for 60% of the dose. 
Eliminacija Glavni put eliminacije dimetilfumarata je izdisanje CO2, čime se eliminira 60% doze.
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). 
Farmakokinetički profil dimetilfumarata u dozi od 240 mg primjenjivane dvaput na dan bio je procijenjen u malom otvorenom nekontroliranom ispitivanju u bolesnika s RRMS-om u dobi od 13 do 17 godina (n=21).
Most subjects, including those who experienced a serious herpes zoster infection, had lymphocyte counts above the lower limit of normal. 
U većine ispitanika, uključujući i one u kojih je nastupila ozbiljna herpes zoster infekcija, broj limfocita bio je iznad donje granice normale.
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. 
U dvama ispitivanjima sa zdravim dobrovoljcima, primjena 325 mg (ili ekvivalenta) acetilsalicilatne kiseline bez acidorezistentne ovojnice, 30 minuta prije Tecfidere, kroz 4 dana odnosno kroz 4 tjedna doziranja, nije promijenila farmakokinetički profil Tecfidere.
There are no data on the effects of dimethyl fumarate on human fertility. 
Nema podataka o učinku dimetilfumarata na plodnost u ljudi.
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. 
Na temelju znanstvenih zaključaka za dimetilfumarat (multipla skleroza), CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) dimetilfumarat (multipla skleroza) nepromijenjen, uz predložene izmjene informacija o lijeku.
These may affect up to 1 in 100 people: - Allergic reactions (hypersensitivity) - reduction in blood platelets 
Mogu se javiti u do 1 na 100 osoba: - alergijske reakcije (preosjetljivost)
Tecfidera has not been studied in combination with anti-neoplastic or immunosuppressive therapies and caution should, therefore, be used during concomitant administration. 
Tecfidera nije ispitivana u kombinaciji s antineoplastičnim ili imunosupresivnim terapijama pa je stoga potreban oprez tijekom istodobne primjene.
No untoward clinical consequences were observed in clinical trials. 
U kliničkim ispitivanjima nisu opažene nepovoljne kliničke posljedice.
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). 
Ako se terapija nastavlja u prisutnosti umjerene do teške produljene limfopenije, ne može se isključiti rizik od oportunističke infekcije, uključujući PML (vidjeti dio 4.4,
No malformations were observed at any dose of dimethyl fumarate in rats or rabbits. 
Nisu zabilježene malformacije kod bilo koje doze dimetilfumarata u štakora ili kunića.
What Tecfidera is used for Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients. 
Tecfidera se koristi za liječenje relapsno-remitirajuće multiple skleroze (MS) u odraslih bolesnika.
In rare cases hypophosphataemic osteomalacia with nonlocalised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur. 
U rijetkim slučajevima može se pojaviti hipofosfatemična osteomalacija s nelokaliziranim koštanim bolovima, povišenom razinom alkalne fosfataze u serumu i stres frakturama.
Tecfidera is a medicine that contains the active substance dimethyl fumarate. 
Tecfidera je lijek koji sadrži djelatnu tvar dimetilfumarat.
Dimethyl fumarate exposure increases in an approximately dose proportional manner with single and multiple doses in the 120 mg to 360 mg dose range studied. 
Izloženost dimetilfumaratu povećava se približno proporcionalno dozi s jednokratnim i višekratnim dozama u ispitivanom rasponu od 120 mg do 360 mg.
- Very common (≥1/10) - Common (≥1/100 to <1/10) - Uncommon (≥1/1, 000 to <1/100) - Rare (≥1/10, 000 to <1/1,000) 
Incidencija nuspojava je izražena prema sljedećim kategorijama: - vrlo često (≥1/10) - često (≥1/100 i <1/10) - manje često (≥1/1000 i <1/100)
Prior to initiating treatment with Tecfidera, a current complete blood count, including lymphocytes, must be performed. 
Prije početka liječenja Tecfiderom mora se provesti kompletna krvna slika, uključujući limfocite.
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. 
U štakora, incidencija bubrežnog tubularnog karcinoma bila je povećana pri 100 mg/kg/dan, pri približno 2 puta višoj izloženosti od preporučene ljudske doze.
No studies have been performed evaluating the efficacy and safety of Tecfidera when switching patients from other disease modifying therapies to Tecfidera. 
Nema provedenih ispitivanja ocjene djelotvornosti i sigurnosti Tecfidere prilikom prelaska bolesnika s druge terapije koja modificira tijek bolesti na Tecfideru.
Discontinuations due to elevated hepatic transaminases were <1% and similar in patients treated with Tecfidera or placebo. 
Prekid liječenja zbog povišenih razina jetrenih transaminaza bio je <1% i sličan u bolesnika liječenih Tecfiderom ili placebom.
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). 
Kratka kura liječenja dozom od 75 mg acetilsalicilatne kiseline bez acidorezistentne ovojnice može imati povoljan učinak u bolesnika s nepodnošljivim navalama crvenila (vidjeti dio 4.5).
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). 
Među 10 bolesnika s podacima o provedenom MR-u između 64. i 72. tjedna nastavka ispitivanja, medijan broja ispitanika s novim ili novoproširenim T2 hiperintenzivnim lezijama bio je 0
The findings were observed at approximately the recommended dose in rats and 3 times the recommended dose in dogs (AUC basis). 
Nalazi su primijećeni kod otprilike preporučene doze u štakora i one 3 puta veće od preporučene doze kod pasa (na temelju
Renal and faecal elimination are secondary routes of elimination, accounting for 15.5% and 0.9% of the dose respectively. 
Sekundarni putovi eliminacije su preko bubrega i fecesa, što čini 15,5% odnosno 0,9% doze.
Since the renal pathway is a secondary route of elimination for dimethyl fumarate accounting for less than 16% of the dose administered, evaluation of pharmacokinetics in individuals with renal impairment was not conducted. 
Budući da je bubrežna eliminacija sekundarni put eliminacije dimetilfumarata, što čini manje od 16% primijenjene doze, procjena farmakokinetike u pojedinaca s oštećenjem bubrega nije provedena.
The limited long-term experience with Tecfidera could contribute to the low evidence regarding a potential association of dimethyl fumarate and Fanconi syndrome in the MS indication. 
Moguće je da je ograničeno iskustvo dugotrajne primjene lijeka Tecfidera pridonosi niskoj razini dokaza potencijalne povezanosti dimetilfumarata i Fanconijeva sindroma u indikaciji multiple skleroze.
In subjects with multiple sclerosis, two 240 mg doses were administered 4 hours apart as part of a three times a day dosing regimen. 
ispitivanjima s ispitanicima s multiplom sklerozom, dvije doze od 240 mg su primijenjene u razmaku od 4 sata, kao dio rasporeda doziranja od tri puta dnevno.
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). 
Rijedak ali ozbiljan poremećaj bubrega (Fanconijev sindrom) prijavljen je uz primjenu lijeka koji sadrži dimetilfumarat u kombinaciji s drugim esterima fumaratne kiseline, a koristi se za liječenje psorijaze (kožne bolesti).
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). 
Ti su podaci dobiveni iz 2 pivotalna, placebom kontrolirana i dvostruko slijepa klinička ispitivanja faze 3, s ukupno 1529 bolesnika liječenih Tecfiderom i do 24 mjeseca uz ukupnu izloženost od 2371 bolesnik-godine (vidjeti dio 5.1).
The mechanism by which dimethyl fumarate exerts therapeutic effects in multiple sclerosis is not fully understood. 
Mehanizam kojim dimetilfumarat ispoljava terapijsko djelovanje u multiploj sklerozi nije u potpunosti razjašnjen.
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. 
U usporedbi s placebom, ispitanici liječeni Tecfiderom su imali klinički značajno i statistički značajno smanjenje: udjela ispitanika s relapsom unutar 2 godine (primarna mjera ishoda Ispitivanja 1) i godišnje stopa relapsa nakon 2 godine (primarna mjera ishoda Ispitivanja 2).
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. 
U malom 24-tjednom otvorenom nekontroliranom ispitivanju u pedijatrijskih bolesnika s relapsno-remitirajućom multiplom sklerozom (RRMS) u dobi od 13 do 17 godina (120 mg dvaput na dan tijekom 7 dana te potom 240 mg dvaput na dan tijekom preostalog razdoblja liječenja; populacija u kojoj se procjenjivala sigurnost, n=22), nakon kojeg je uslijedio nastavak ispitivanja u trajanju od 96 tjedana (240 mg dvaput na dan; populacija u kojoj se procjenjivala sigurnost n=20), sigurnosni profil je bio sličan onome opaženom u odraslih bolesnika.
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). 
Incidencija papiloma skvamoznih stanica i karcinoma nežljezdanog želuca (predželuca) bila je povećana pri ekvivalentnoj izloženosti preporučene ljudske doze u miševa i ispod izloženosti preporučene ljudske doze u štakora (na temelju AUC-a).
However, Tecfidera should be taken with food due to improved tolerability with respect to flushing or gastrointestinal adverse events (see section 4.2). 
Međutim, Tecfideru treba uzeti s hranom, jer se time poboljšava podnošljivost obzirom na navalu crvenila ili gastrointestinalne štetne događaje (vidjeti dio 4.2).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS HEAT SEALED BLISTER CARD 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP TOPLINSKI ZATVORENA BLISTER KARTICA
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. 
Nisu provedena ispitivanja učinka na sposobnost upravljanja vozilima i rada sa strojevima, ali u kliničkim ispitivanjima nije ustanovljeno da su učinci koji bi mogli utjecati na tu sposobnost povezani s dimetilfumaratom.
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. 
U jednom in vivo ispitivanju istodobna primjena Tecfidere s kombiniranim oralnim kontraceptivima (norgestimat i etinilestradiol) nije značajno promijenila izloženost oralnim kontraceptivima.
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. 
4.2 Doziranje i način primjene Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju multiple skleroze.