natgillin/translations-raw huggingface dataset:
Response to Skilarence can be generally seen as early as week 3 and improves over time. 
Odziv na zdravilo Skilarence lahko običajno opazimo že v 3. tednu in se sčasoma izboljšuje.
See the instructions in the patient leaflet of the contraceptive you are taking. 
Glejte navodila za uporabo kontracepcijskega sredstva, ki ga jemljete.
Patients received treatment for up to 16 weeks and follow-up visits were planned for up to 12 months after treatment was stopped. 
Bolniki so prejemali zdravljenje do 16. tednov, kontrolni obiski pa so bili načrtovani do 12 mesecev po zaključku zdravljenja.
The apparent terminal elimination half-life of monomethyl fumarate is about 2 hours. 
Očitni končni razpolovni čas monometilfumarata je približno 2 uri.
Take the next dose at the usual time and continue taking the medicine exactly as described in this leaflet or exactly as agreed with your doctor. 
Naslednji odmerek vzemite ob običajnem času in nadaljujte z jemanjem zdravila natančno po teh navodilih oziroma natančno po zdravnikovih navodilih.
Two-sided 99.24% CI 
Dvostranski 99,24 % IZ
If you forget to take Skilarence 
Če ste pozabili vzeti zdravilo Skilarence
Prior to launch of Skilarence in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila Skilarence na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
Your doctor will advise you on what care you need to take during Skilarence treatment. 
Zdravnik vam bo svetoval, na kaj morate biti pozorni med zdravljenjem z zdravilom Skilarence.
Long-term efficacy data are currently not available for Skilarence, however, in the pharmacokinetic and clinical studies the systemic exposure, efficacy and safety of Skilarence were shown to be comparable to the active comparator containing dimethyl fumarate. 
Podatki o dolgoročni učinkovitosti zdravila Skilarence trenutno niso na voljo, vendar pa so v farmakokinetičnih in kliničnih študijah dokazali, da so sistemska izpostavljenost, učinkovitost in varnost zdravila Skilarence primerljive z aktivno primerjavo, ki vsebuje dimetilfumarat.
If treatment success is observed before the maximum dose is reached, no further increase of dose is necessary. 
Če je zdravljenje uspešno, preden je dosežen največji odmerek, nadaljnje povečevanje odmerka ni potrebno.
The mean and median values of lymphocytes remained within the normal range during the clinical study. 
Povprečna in mediana vrednost limfocitov sta v klinični študiji ostali znotraj običajnega razpona.
Breakfast 
Zajtrk
Use effective methods of contraception to avoid becoming pregnant during treatment with Skilarence (see also “Other medicines and Skilarence” above). 
Uporabljajte učinkovite kontracepcijske metode, da boste preprečili zanositev med zdravljenjem z zdravilom Skilarence (glejte tudi »Druga zdravila in zdravilo Skilarence« zgoraj).
The majority of patients reported a “very large” or “extremely large” effect of psoriasis on their life based on the Dermatology Life Quality Index (DLQI), with a mean DLQI score of 11.5. 
Večina bolnikov je poročala o »zelo velikem« ali »izjemno velikem« vplivu psoriaze na njihovo življenje na podlagi indeksa DLQI [dermatološki indeks kakovosti življenja], kjer je povprečna ocena DLQI znašala 11,5.
At week 16 (end of treatment), there was no further decline in lymphocyte counts. 
V 16. tednu (konec zdravljenja) ni bilo dodatnega zmanjšanja števila limfocitov.
Before treatment 
Pred zdravljenjem
Clinical studies of Skilarence did not include sufficient numbers of patients aged 65 years and above to determine whether they respond differently compared to patients under 65 years (see section 5.2). 
Klinične študije z zdravilom Skilarence niso vključevale zadostnega števila bolnikov, starih 65 let in več, da bi bilo mogoče ugotoviti, ali se odzivajo drugače, v primerjavi z bolniki, ki so mlajši od 65 let (glejte poglavje 5.2).
Early diagnosis of Fanconi syndrome and discontinuation of Skilarence treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible. 
Zgodnja diagnoza Fanconijevega sindroma in prekinitev zdravljenja z zdravilom Skilarence sta pomembni za preprečevanje nastopa ledvične okvare in osteomalacije, saj je sindrom običajno reverzibilen.
Of the 699 patients, most were Caucasian (99%) and male (65%), and the mean age was 44 years. 
Od 699 bolnikov je bila večina belcev (99 %) in moškega spola (65 %), povprečna starost pa je bila 44 let.
Skilarence is an immunomodulator and may affect the way the immune system responds to infection. 
Zdravilo Skilarence je imunomodulator in lahko vpliva na način odzivanja imunskega sistema na okužbo.
Depending on the results of these blood and urine tests, your doctor may reduce your dose of Skilarence or stop treatment. 
Glede na rezultate teh krvnih in urinskih preiskav vam lahko vaš zdravnik zmanjša odmerek zdravila
No apparent dose relationship and no risk factors for the occurrence of these adverse reactions could be identified. 
Odkrili niso nobene očitne povezave z odmerkom in nobenih dejavnikov tveganja za pojav teh neželenih učinkov.
Skilarence may cause problems with your blood, liver or kidneys. 
Zdravilo Skilarence lahko povzroči težave s krvjo, jetri ali ledvicami.
Other medicines and Skilarence 
Druga zdravila in zdravilo Skilarence
Reddening of the face or body (flushing) is a very common side effect which may affect more than 1 in 10 people. 
Rdečina obraza ali telesa (zardevanje) je zelo pogost neželeni učinek, ki prizadene več kot 1 od 10 bolnikov.
Importantly, Fanconi syndrome can occur without elevated creatinine levels or low glomerular filtration rate. 
Pomembno je vedeti, da se lahko Fanconijev sindrom pojavi brez povišanih ravni kreatinina ali nizke stopnje glomerulne filtracije.
These adducts were detected in animal studies in the intestinal mucosa of rats and to a smaller extent in portal vein blood. 
Te adukte so zaznali v študijah na živalih v črevesni sluznici podgan in v manjši meri v krvi v portalni veni.
Maintenance of long term efficacy has been well described for other dimethyl fumarate-containing products, and therefore the treatment benefits seen with Skilarence at 16 weeks can be expected to be maintained in patients treated over the long term for at least 24 months. 
Ohranjanje dolgoročne učinkovitosti je bilo dobro opisano za druga zdravila, ki vsebujejo dimetilfumarat, zato je mogoče pričakovati, da se bodo učinki zdravljenja, ki so jih opazili pri zdravilu Skilarence v 16. tednu, ohranili pri bolnikih, ki so bili zdravljeni v daljšem obdobju vsaj 24 mesecev.
What you need to know before you take Skilarence 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Skilarence 3.
If you need a vaccination, talk to your doctor. 
Če potrebujete cepljenje, se posvetujte z zdravnikom.
This interaction with glutathione leads to the inhibition of translocation into the nucleus and the transcriptional activity of the nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB). 
Ta interakcija z glutationom povzroča inhibicijo translokacije v nukleus in transkripcijsko dejavnost stopnjevalca nuklearnega faktorja kappa lahke verige aktiviranih celic B (NF-κB).
Skilarence is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. 
Zdravilo Skilarence je namenjeno za uporabo pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnostiko in zdravljenjem psoriaze.
It is recommended to monitor hepatic function (SGOT, SGPT, gamma-GT, AP) prior to initiation of treatment and every 3 months thereafter, since elevation of hepatic enzymes has been observed in some patients in the Phase III study. 
Priporočljivo je spremljanje delovanja jeter (SGOT, SGPT, gama-GT, AP) pred uvedbo zdravljenja in vsake 3 mesece po tem, saj so pri nekaterih bolnikih iz študije III. faze opazili porast jetrnih encimov.
If you take more Skilarence than you should If you think you have taken too many Skilarence tablets, talk to your doctor or pharmacist. 
Če ste vzeli večji odmerek zdravila Skilarence, kot bi smeli Če menite, da ste vzeli preveliko število tablet zdravila Skilarence, se posvetujte z zdravnikom ali farmacevtom.
In particular, if you are taking a contraceptive medicine (the pill), the effect may be reduced and you may need to use other barrier methods to prevent pregnancy. 
Zlasti, če jemljete kontracepcijska sredstva (kontracepcijske tablete), se njihov učinek lahko zmanjša in boste morda za preprečevanje nosečnosti morali uporabljati druge, pregradne kontracepcijske metode.
Dimethyl fumarate does not show any binding affinity to serum proteins which may further contribute to its rapid elimination from the circulation. 
Dimetilfumarat ne kaže nobene vezavne afinitete za serumske beljakovine, kar lahko nadalje prispeva k njegovemu hitremu izločanju iz krvnega obtoka.
Dosage modifications may also be necessary if abnormalities in laboratory parameters are observed (see section 4.4). 
Prilagoditve odmerkov bodo morda potrebne tudi, če se pokažejo abnormalnosti v laboratorijskih parametrih (glejte poglavje 4.4).
The benefits of treatment with Skilarence were also supported by patient self-perceived improvements in their quality of life. 
Koristi zdravljenja z zdravilom Skilarence so podprla tudi izboljšanja kakovosti življenja bolnikov, kot so jih zaznali bolniki sami.
Based on the pharmacology of dimethyl fumarate, a need for dose adjustment in the elderly is not expected. 
Na podlagi farmakologije dimetilfumarata ni pričakovati potrebe po prilagajanju odmerka pri starejših.
Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »EXP«.
What Skilarence is and what it is used for 2. 
Kaj je zdravilo Skilarence in za kaj ga uporabljamo 2.
Typical symptoms associated with PML are diverse, become worse 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. 
Tipični simptomi, povezani s PML, so raznoliki, se v obdobju nekaj dni do tednov poslabšajo in vključujejo progresivno šibkost ene strani telesa ali nespretnost udov, motnje vida in spremembe v razmišljanju, spominu in orientaciji, kar vodi v zmedenost in spremembe osebnosti.
The MAH shall ensure that in each Member State where Skilarence is marketed, healthcare professionals who are expected to prescribe and dispense Skilarence have access to the following educational package. 
Imetnik dovoljenja za promet mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Skilarence trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo zdravilo predpisovali in izdajali, prejeli naslednji paket izobraževalnih gradiv.
Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to 24 months. 
Izkušnje s podobnimi zdravili, ki vsebujejo dimetilfumarat, kažejo koristi zdravljenja do vsaj 24 mesecev.
This could cause stomach and intestinal problems. 
To lahko povzroči težave z želodcem in črevesjem.
9/L but is ≥0.7 x10 
9/l, vendar je ≥ 0,7 x 10
Evening of dimethyl fumarate 
Zvečer dimetilfumarata
Taking Skilarence with food delayed the tmax of monomethyl fumarate from 3.5 to 9.0 hours. 
Jemanje zdravila Skilarence skupaj s hrano je upočasnilo tmax monometilfumarata s 3,5 na 9,0 ur.
9/L, the blood test must be repeated and if the levels are confirmed to be below 0.7x10 
9/l, je treba krvno preiskavo ponoviti in če so potrjene vrednost pod 0,7 x 10
Therefore, the tablets should not be crushed, divided, dissolved or chewed. 
Zato se tablet ne sme drobiti, deliti, topiti ali žvečiti.
For symptoms see below. 
Za simptome teh bolezni glejte besedilo spodaj.
The maximum daily dose allowed is 720 mg (3 x 2 tablets of Skilarence 120 mg). 
Največji dovoljeni dnevni odmerek je 720 mg (3 x 2 tableti zdravila Skilarence 120 mg).
Patients receiving Skilarence should be instructed to report symptoms of infection to a physician. 
Bolnikom, ki prejemajo zdravilo Skilarence, je treba naročiti, da morajo o simptomih okužbe poročati zdravniku.
Patients who develop lymphopenia should be monitored for signs and symptoms of opportunistic infections, particularly for symptoms indicative of PML. 
Bolnike, pri katerih se razvije limfopenija, je treba spremljati glede znakov in simptomov oportunističnih okužb, še zlasti glede simptomov, ki kažejo na PML.
This dose is then increased by 1 Skilarence 120 mg tablet per week at different times of day for the subsequent 5 weeks, as shown in the table below. 
Ta odmerek se nato povečuje za 1 tableto zdravila Skilarence 120 mg na teden v različnih obdobjih dneva nadaljnjih 5 tednov, kot je prikazano v spodnji preglednici.
During the Phase III placebo-controlled clinical trial, renal function was not seen to deteriorate during therapy across treatment groups. 
V kliničnem preskušanju III. faze, nadzorovanem s placebom, v skupinah zdravljenja niso opazili poslabšanja delovanja ledvic med zdravljenjem.
From the fourth week, treatment is switched to only 1 tablet of Skilarence 120 mg in the evening. 
Od četrtega tedna dalje se zdravljenje zamenja z 1 samo tableto zdravila Skilarence 120 mg zvečer.
If a patient develops an infection during treatment with Skilarence, suspension of treatment should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy. 
Če se pri bolniku med zdravljenjem z zdravilom Skilarence razvije okužba, je treba razmisliti o prekinitvi zdravljenja in pred ponovno uvedbo zdravljenja znova oceniti koristi in tveganja.
E-08740 Sant Andreu de la Barca, Barcelona Spain 
E-08740 Sant Andreu de la Barca, Barcelona Španija
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death. 
Progresivna multifokalna levkoencefalopatija (PML) je redka, a resna okužba možganov, ki lahko povzroči hudo prizadetost ali smrt.
Treatment week 
Teden zdravljenja
593, Sant Andreu de la Barca, Barcelona, 08740, Spain 
593, Sant Andreu de la Barca, Barcelona, 08740, Španija
Take your tablets during or immediately after a meal. 
Tablete vzemite skupaj s hrano ali takoj po obroku.
The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia). 
Najpomembnejši znaki so: proteinurija, glukozurija (z normalnimi ravnmi sladkorja v krvi), hiperaminoacidurija in fosfaturija (lahko sočasno s hipofosfatemijo).
Exhalation of CO2 resulting from the metabolism of monomethyl fumarate is the primary route of elimination; only small amounts of intact monomethyl fumarate are excreted through urine or faeces. 
Izdihovanje CO2, ki nastane zaradi presnove monometilfumarata, je primarna pot izločanja; le majhne količine intaktnega monometilfumarata se izločajo z urinom ali blatom.
There are limited data from the use of dimethyl fumarate in pregnant women. 
Podatkov o uporabi dimetilfumarata pri nosečnicah je malo.
For the total leukocyte count, a decline became apparent at week 12 of treatment; it slowly increased again at week 16 (end of treatment); and 12 months after stopping treatment all patients had values above 3.0x10 
Pri skupnem številu levkocitov je zmanjšanje postalo očitno v 12. tednu zdravljenja; število je počasi znova naraslo v 16. tednu (konec zdravljenja); dvanajst mesecev po prenehanju zdravljenja pa so imeli vsi bolniki vrednosti nad 3,0 x 10
In case of individual intolerability of the increased dosage during weeks 4 to 16, the patient was to return to the last tolerated dose taken since the start of week 4, which was to be maintained until end of the treatment period (week 16). 
V primeru neprenašanja povečanega odmerka pri posamezniku od 4. do 16. tedna so bolnika vrnili na zadnji prenašani odmerek, ki ga je jemal od začetka 4. tedna, in ta odmerek je moral bolnik jemati so konca obdobja zdravljenja (16. teden).
No studies on the ability to drive and use machines have been conducted. 
Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
Leukopenia: If a marked decrease in the total number of white blood cells is found, the situation should be monitored carefully and treatment with Skilarence should be discontinued at levels below 3.0x10 
Levkopenija: Če je ugotovljeno izrazito zmanjšanje skupnega števila belih krvničk, je treba stanje natančno spremljati, zdravljenje z zdravilom Skilarence pa je treba prekiniti, če so ravni nižje od 3,0 x 9/l.
Published clinical experience with dimethyl fumarate-containing products shows that individual episodes of flushing usually begin shortly after taking the tablets and resolve within a few hours. 
Objavljene klinične izkušnje z zdravili, ki vsebujejo dimetilfumarat, kažejo, da so se posamezne epizode vročinskega oblivanja običajno začele kmalu po zaužitju tablet in so izzvenele v nekaj urah.
When switching patients from such therapies to Skilarence, the half-life and mode of action of the other therapy should be considered in order to avoid additive effects on the immune system. 
Ob prehodu bolnikov s teh zdravljenj na zdravljenje z zdravilom Skilarence je treba upoštevati razpolovni čas in način delovanja teh drugih zdravil, da se izognemo aditivnim učinkom na imunski sistem.
You will have blood and urine tests before treatment and then regularly during your treatment to make sure that you are not getting these complications and can continue to take this medicine. 
Pred zdravljenjem in nato v rednih intervalih med zdravljenjem bodo pri vas opravili krvne in urinske preiskave, s katerimi se bodo prepričali, da se ti zapleti ne bodo pojavili pri vas in da lahko še naprej jemljete to zdravilo.
The European Medicines Agency has waived the obligation to submit the results of studies with Skilarence in all subsets of the paediatric population in this indication (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Skilarence za eno ali več podskupin pediatrične populacije s to indikacijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
More than 90% of these diarrhoea events were of mild to moderate severity (see section 4.4). 
Več kot 90 % teh dogodkov diareje je bilo blage do zmerne jakosti (glejte poglavje 4.4).
Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness. 
Napredovanje lahko vključuje simptome, kot so poliurija, polidipsija in šibkost proksimalnih mišic.
Renal function (e.g. creatinine, blood urea nitrogen and urinalysis) should be checked prior to initiation of treatment and every 3 months thereafter. 
Delovanje ledvic (npr. kreatinin, dušik sečnine v krvi in analiza urina) je treba preveriti pred uvedbo zdravljenja in vsake 3 mesece po tem.
Uncommon Not known Not known 
občasni neznana neznana
Unconjugated dimethyl fumarate, however, cannot be detected in the plasma of animals or psoriatic patients following oral administration. 
Nekonjugiranega dimetilfumarata pa ni mogoče zaznati v plazmi živali ali psoriatričnih bolnikov po peroralnem dajanju.
If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further. 
Če opazite, da izločate več urina, ste bolj žejni ali pijete več kot običajno, da se vaše mišice zdijo šibkejše, se vam zlomi kost ali da imate bolečine, se čimprej posvetujte z zdravnikom, ki bo te znake dodatno raziskal.
In cases of severe or prolonged diarrhoea during treatment with Skilarence, absorption of other medicinal products may be affected. 
V primerih hude ali dlje časa trajajoče diareje med zdravljenjem z zdravilom Skilarence se lahko spremeni absorpcija drugih zdravil.
After your condition has improved sufficiently, your doctor will consider how to gradually reduce the daily dose of Skilarence to what you need to maintain your improvement. 
Ko se bo vaše stanje zadovoljivo izboljšalo, bo zdravnik razmislil o tem, kako postopno zmanjšati dnevni odmerek zdravila Skilarence na odmerek, ki je potreben za ohranitev tega izboljšanja.
Risk factors can include previous immunosuppressive treatment and the existence of certain concomitant disorders (such as some autoimmune disorders or malignant haematological conditions). 
Dejavniki tveganja lahko vključujejo preteklo imunosupresivno zdravljenje in obstoj določenih sočasnih bolezni (npr. nekaterih avtoimunih bolezni ali malignih krvnih bolezni).
If treatment success was observed before the maximum dose of 720 mg/day of dimethyl fumarate was reached, no further increase of dosage was necessary and the dosage was to be steadily reduced to an individual maintenance dose. 
Če so opazili uspešnost zdravljenja pred doseženim največjim odmerkom dimetilfumarata 720 mg/dan, ni bilo potrebno nadaljnje večanje odmerka in odmerek so enakomerno zmanjševali na vzdrževalni odmerek za posameznika.
Hence it is reasonable to expect the long-term efficacy of Skilarence to also be comparable to dimethyl fumarate-containing products. 
Zato je smotrno pričakovati, da bodo dolgoročni učinki zdravila Skilarence prav tako primerljivi z dolgoročnimi učinki zdravil, ki vsebujejo dimetilfumarat.
Fertility There are no human or animal data on the effects of Skilarence on fertility. 
Plodnost Ni podatkov iz študij pri ljudeh ali na živalih o vplivu zdravila Skilarence na plodnost.
Renal findings in dogs included minimal to moderate tubular hypertrophy, increased incidence and severity of tubular vacuolation and minimal to slight tubular degeneration, which were considered toxicologically relevant. 
Ugotovitve v zvezi z jetri pri psih so vključevale minimalno do zmerno tubularno hipertrofijo, povečano incidenco in jakost tubularne vakuolacije in minimalno do rahlo tubularno degeneracijo, ki so jih upoštevali kot toksikološko pomembne.
Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided because it may lead to increased dissolution rates of Skilarence and, therefore, may increase the frequency of gastrointestinal adverse reactions. 
Treba se je izogibati uživanju večjih količin močnih alkoholnih pijač (z več kot 30 % volumskimi odstotki alkohola), saj lahko povečajo stopnje raztapljanja zdravila Skilarence in lahko na ta način povečajo pogostnost neželenih reakcij v prebavilih.
However, there was an increased number of foetuses with the variations “supernumerary liver lobe” and “abnormal iliac alignment” at maternally toxic doses. 
Kljub temu pa so opazili povečano število zarodkov s spremembami »nadštevilni lobus jeter« in »nenormalna iliakalna povezava« pri odmerkih, toksičnih za mater.
How to take Skilarence 4. 
Kako jemati zdravilo Skilarence 4.
Haematological changes 
Hematološke spremembe
Rebound (defined as worsening of ≥125% of baseline PASI value) was assessed after 2 months off treatment and was shown not to be a clinical concern with fumaric acid esters, as it was documented in very few patients (Skilarence 1.1% and active comparator 2.2%, compared to 9.3% in the placebo group). 
Ponovni pojav simptomov (opredeljen kot poslabšanje za ≥ 125 % od izhodiščne vrednosti PASI) so ocenili po 2 mesecih brez zdravljenja in dokazali, da ta pri estrih fumarne kisline ne predstavlja kliničnega zadržka, saj je bil dokumentiran pri zelo majhnem številu bolnikov (Skilarence 1,1 % in aktivna primerjava 2,2 %, v primerjavi z 9,3 % v skupini s placebom).