FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to 24 months.
Slovenian: Izkušnje s podobnimi zdravili, ki vsebujejo dimetilfumarat, kažejo koristi zdravljenja do vsaj 24 mesecev.
English: This could cause stomach and intestinal problems.
Slovenian: To lahko povzroči težave z želodcem in črevesjem.
English: 9/L but is ≥0.7 x10
Slovenian: 9/l, vendar je ≥ 0,7 x 10
English: Evening of dimethyl fumarate
Slovenian: Zvečer dimetilfumarata
English: Taking Skilarence with food delayed the tmax of monomethyl fumarate from 3.5 to 9.0 hours.
Slovenian: Jemanje zdravila Skilarence skupaj s hrano je upočasnilo tmax monometilfumarata s 3,5 na 9,0 ur.
English: 9/L, the blood test must be repeated and if the levels are confirmed to be below 0.7x10
Slovenian: 9/l, je treba krvno preiskavo ponoviti in če so potrjene vrednost pod 0,7 x 10
English: Therefore, the tablets should not be crushed, divided, dissolved or chewed.
Slovenian: Zato se tablet ne sme drobiti, deliti, topiti ali žvečiti.
English: For symptoms see below.
Slovenian: Za simptome teh bolezni glejte besedilo spodaj.
English: The maximum daily dose allowed is 720 mg (3 x 2 tablets of Skilarence 120 mg).
Slovenian: Največji dovoljeni dnevni odmerek je 720 mg (3 x 2 tableti zdravila Skilarence 120 mg).
English: Patients receiving Skilarence should be instructed to report symptoms of infection to a physician.
Slovenian: Bolnikom, ki prejemajo zdravilo Skilarence, je treba naročiti, da morajo o simptomih okužbe poročati zdravniku.
English: Patients who develop lymphopenia should be monitored for signs and symptoms of opportunistic infections, particularly for symptoms indicative of PML.
Slovenian: Bolnike, pri katerih se razvije limfopenija, je treba spremljati glede znakov in simptomov oportunističnih okužb, še zlasti glede simptomov, ki kažejo na PML.
English: 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.
Slovenian: 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.
English: During the Phase III placebo-controlled clinical trial, renal function was not seen to deteriorate during therapy across treatment groups.
Slovenian: V kliničnem preskušanju III. faze, nadzorovanem s placebom, v skupinah zdravljenja niso opazili poslabšanja delovanja ledvic med zdravljenjem.
English: From the fourth week, treatment is switched to only 1 tablet of Skilarence 120 mg in the evening.
Slovenian: Od četrtega tedna dalje se zdravljenje zamenja z 1 samo tableto zdravila Skilarence 120 mg zvečer.
English: 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.
Slovenian: 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.
English: E-08740 Sant Andreu de la Barca, Barcelona Spain
Slovenian: E-08740 Sant Andreu de la Barca, Barcelona Španija
English: Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death.
Slovenian: Progresivna multifokalna levkoencefalopatija (PML) je redka, a resna okužba možganov, ki lahko povzroči hudo prizadetost ali smrt.
English: Treatment week
Slovenian: Teden zdravljenja
English: 593, Sant Andreu de la Barca, Barcelona, 08740, Spain
Slovenian: 593, Sant Andreu de la Barca, Barcelona, 08740, Španija
English: Take your tablets during or immediately after a meal.
Slovenian: Tablete vzemite skupaj s hrano ali takoj po obroku.
English: The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
Slovenian: Najpomembnejši znaki so: proteinurija, glukozurija (z normalnimi ravnmi sladkorja v krvi), hiperaminoacidurija in fosfaturija (lahko sočasno s hipofosfatemijo).
English: 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.
Slovenian: Izdihovanje CO2, ki nastane zaradi presnove monometilfumarata, je primarna pot izločanja; le majhne količine intaktnega monometilfumarata se izločajo z urinom ali blatom.
English: There are limited data from the use of dimethyl fumarate in pregnant women.
Slovenian: Podatkov o uporabi dimetilfumarata pri nosečnicah je malo.
English: 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
Slovenian: 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
English: 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).
Slovenian: 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).
English: No studies on the ability to drive and use machines have been conducted.
Slovenian: Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: More than 90% of these diarrhoea events were of mild to moderate severity (see section 4.4).
Slovenian: Več kot 90 % teh dogodkov diareje je bilo blage do zmerne jakosti (glejte poglavje 4.4).
English: Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
Slovenian: Napredovanje lahko vključuje simptome, kot so poliurija, polidipsija in šibkost proksimalnih mišic.
English: Renal function (e.g. creatinine, blood urea nitrogen and urinalysis) should be checked prior to initiation of treatment and every 3 months thereafter.
Slovenian: Delovanje ledvic (npr. kreatinin, dušik sečnine v krvi in analiza urina) je treba preveriti pred uvedbo zdravljenja in vsake 3 mesece po tem.
English: Uncommon Not known Not known
Slovenian: občasni neznana neznana
English: Unconjugated dimethyl fumarate, however, cannot be detected in the plasma of animals or psoriatic patients following oral administration.
Slovenian: Nekonjugiranega dimetilfumarata pa ni mogoče zaznati v plazmi živali ali psoriatričnih bolnikov po peroralnem dajanju.
English: 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.
Slovenian: 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.
English: In cases of severe or prolonged diarrhoea during treatment with Skilarence, absorption of other medicinal products may be affected.
Slovenian: V primerih hude ali dlje časa trajajoče diareje med zdravljenjem z zdravilom Skilarence se lahko spremeni absorpcija drugih zdravil.
English: 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.
Slovenian: 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.
English: Risk factors can include previous immunosuppressive treatment and the existence of certain concomitant disorders (such as some autoimmune disorders or malignant haematological conditions).
Slovenian: Dejavniki tveganja lahko vključujejo preteklo imunosupresivno zdravljenje in obstoj določenih sočasnih bolezni (npr. nekaterih avtoimunih bolezni ali malignih krvnih bolezni).
English: 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.
Slovenian: 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.
English: Hence it is reasonable to expect the long-term efficacy of Skilarence to also be comparable to dimethyl fumarate-containing products.
Slovenian: Zato je smotrno pričakovati, da bodo dolgoročni učinki zdravila Skilarence prav tako primerljivi z dolgoročnimi učinki zdravil, ki vsebujejo dimetilfumarat.
English: Fertility There are no human or animal data on the effects of Skilarence on fertility.
Slovenian: Plodnost Ni podatkov iz študij pri ljudeh ali na živalih o vplivu zdravila Skilarence na plodnost.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: However, there was an increased number of foetuses with the variations “supernumerary liver lobe” and “abnormal iliac alignment” at maternally toxic doses.
Slovenian: Kljub temu pa so opazili povečano število zarodkov s spremembami »nadštevilni lobus jeter« in »nenormalna iliakalna povezava« pri odmerkih, toksičnih za mater.
English: How to take Skilarence 4.
Slovenian: Kako jemati zdravilo Skilarence 4.
English: Haematological changes
Slovenian: Hematološke spremembe
English: 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).
Slovenian: 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).
English: Some of these side effects, such as reddening of the face or body (flushing), diarrhoea, stomach problems and nausea usually improve as you continue treatment.
Slovenian: Nekateri od teh neželenih učinkov, kot so npr. pordelost obraza ali telesa (zardevanje), driska, želodčne težave in slabost, se običajno izboljšajo v nadaljevanju zdravljenja.
English: The efficacy of oral contraceptives may be reduced and the use of an alternative barrier contraceptive method is recommended to prevent possible failure of contraception (see the prescribing information of the oral contraceptive).
Slovenian: Učinkovitost peroralnih kontracepcijskih sredstev se lahko zmanjša, zato je priporočljivo uporabljati alternativne pregradne kontracepcijske metode, ki preprečuje morebitno odpoved kontracepcije (glejte navodila za predpisovanje peroralnega kontracepcijskega sredstva).
English: Proteinuria* Renal failure* Fanconi syndrome*
Slovenian: Bolezni sečil proteinurija* odpoved ledvic* Fanconijev sindrom*
English: Rare side effects (may affect up to 1 in 1,000 people): - allergic skin reaction
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - alergične reakcije na koži
English: What you need to know before you take Skilarence
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Skilarence
English: In particular, in the clinical study there was a slight decrease in mean lymphocyte counts starting between weeks 3 and 5 and reaching a maximum in week 12 where approximately one third of patients had lymphocyte values below 1.0x10
Slovenian: Še zlasti so v klinični študiji opazili rahlo zmanjšanje povprečnega števila limfocitov, ki se je začelo med tretjim in petim tednom ter doseglo vrh v 12. tednu, ko je imela približno tretjina bolnikov vrednosti limfocitov pod 1,0 x 10
English: The safety and efficacy of Skilarence was assessed in one double-blind, 3-arm, placebo- and active comparator-controlled Phase III study (1102) in patients with moderate to severe plaque psoriasis (Study 1102).
Slovenian: Varnost in učinkovitost zdravila Skilarence so ocenjevali v eni dvojno slepi študiji III. faze (1102) s tremi skupinami, kontrolirani s placebom in aktivnim primerjalnim zdravilom, opravljeni pri bolnikih z zmerno do hudo psoriazo v plakih (Študija 1102).
English: Symptoms include fever, pain, aching muscles, headache, loss of appetite and a general feeling of weakness.
Slovenian: Simptomi vključujejo povišano telesno temperaturo, bolečine, boleče mišice, glavobol, izgubo teka in splošen občutek šibkosti.
English: Further metabolism occurs through oxidation via the tricarboxylic acid cycle forming carbon dioxide and water.
Slovenian: Nadaljnja presnova poteka z oksidacijo prek cikla trikarboksilne kisline, pri čemer nastajata ogljikov dioksid in voda.
English: In the clinical study a total of 20.8% of patients receiving Skilarence experienced flushing, which was mild in the majority of cases (see section 4.4).
Slovenian: V klinični študiji se je pri skupno 20,8 % bolnikov, ki so prejemali zdravilo Skilarence, pojavilo vročinsko oblivanje, ki je bilo v večini primerov blago (glejte poglavje 4.4).
English: If you are affected, be careful when driving or using machines.
Slovenian: Če se ti učinki pojavijo pri vas, bodite pri upravljanju vozil in strojev previdni.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Slovenian: Zdravilo Skilarence vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni 'brez natrija'.
English: After clinically relevant improvement of the skin lesions has been achieved, consideration should be given to gradual reduction of the daily dose of Skilarence to the maintenance dose required by the individual.
Slovenian: Po klinično pomembnem izboljšanju kožnih lezij je treba razmisliti o postopnem zmanjšanju dnevnega odmerka zdravila Skilarence do vzdrževalnega odmerka, ki ga potrebuje posameznik.
English: Patients began treatment with tablets containing 30 mg/day dimethyl fumarate or placebo, titrating up to a maximum of 720 mg/day in both active treatment arms as described in section 4.2.
Slovenian: Bolniki so pričeli zdravljenje s tabletami, ki so vsebovale 30 mg/dan dimetilfumarata ali placebo, s titracijo do največ 720 mg/dan v obeh skupinah z aktivnim zdravljenjem, kot je opisano v poglavju 4.2.
English: The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions; kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML).
Slovenian: Najresnejši neželeni učinki, ki se lahko pojavijo ob zdravljenju z zdravilom Skilarence, so alergijske ali preobčutljivostne reakcije; odpoved ledvic ali bolezen ledvic, imenovana Fanconijev sindrom, ali pa huda okužba možganov, imenovana progresivna multifokalna levkoencefalopatija (PML).
English: Based on available data suggesting that fumaric acid esters may activate cellular pathways related to the development of renal tumours, a potential tumorigenic activity of exogenously administered dimethyl fumarate on the kidneys cannot be excluded.
Slovenian: Na podlagi razpoložljivih podatkov, ki kažejo, da lahko estri fumarne kisline aktivirajo celične poti, povezane z razvojem ledvičnih tumorjev, potenciala za tumorogeno aktivnost eksogeno danega dimetilfumarata na ledvice ni mogoče izključiti.
English: Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets.
Slovenian: Velikosti pakiranj: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 in 400 gastrorezistentnih tablet.
English: Prior to initiating treatment with Skilarence, a current complete blood count (including differential blood count and platelet count) should be available.
Slovenian: Pred uvedbo zdravljenja z zdravilom Skilarence mora biti na voljo trenutna celotna krvna slika (vključno z diferencialno krvno sliko in številom trombocitov).
English: Patients developing lymphopenia should be monitored after stopping treatment until their lymphocyte count has returned to the normal range (see section 4.8).
Slovenian: Bolnike, pri katerih se razvije limfopenija, je treba po končanem zdravljenju spremljati, dokler se njihovo število limfocitov ne vrne v običajen razpon (glejte poglavje 4.8).
English: Skilarence tablets must be swallowed whole with fluid during or immediately after a meal.
Slovenian: Tablete zdravila Skilarence je treba pogoltniti cele s tekočino med jedjo ali takoj po jedi.
English: It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se dimetilfumarat ali njegovi presnovki izločajo v materino mleko.
English: 3/279 (1.1%) of the patients started on Skilarence.
Slovenian: 9/l, kar predstavlja 3/279 (1,1 %) bolnike, pri katerih je bilo uvedeno zdravljenje z zdravilom Skilarence.
English: • The guide for healthcare professionals shall contain the following key elements: o Relevant information on PML (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for PML o Details on how to minimise the risk of PML through appropriate monitoring and management, including laboratory monitoring of lymphocyte and leukocyte prior to and during treatment, and criteria for treatment discontinuation o Key messages to convey in counselling of patients
Slovenian: • Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente: o Pomembne informacije o PML (npr. resnost, izraženost, pogostnost, čas do nastopa, reverzibilnost neželenega učinka, kot je ustrezno) o Podrobnosti o populaciji, pri kateri je tveganje za PML večje o Podrobnosti o možnosti zmanjševanja tveganja za PML z ustreznim spremljanjem in obvladovanjem, vključno z laboratorijskim spremljanjem števila limfocitov in levkocitov pred zdravljenjem in med njim, ter kriteriji za prekinitev zdravljenja o Ključna sporočila, ki jih je treba posredovati bolnikom v okviru svetovanja
English: These medicines taken together with Skilarence could increase the risk of side effects on your kidneys.
Slovenian: Jemanje teh zdravil skupaj z zdravilom Skilarence bi lahko povečalo tveganje za pojav stranskih učinkov na vaše ledvice.
English: Vaccination during treatment with Skilarence has not been studied.
Slovenian: Cepljenja med zdravljenjem z zdravilom Skilarence niso preučevali.
English: The anti-inflammatory and immunomodulating effects of dimethyl fumarate and its metabolite monomethyl fumarate are not fully elucidated but are thought to be mainly due to the interaction with the intracellular reduced glutathione of cells directly involved in the pathogenesis of psoriasis.
Slovenian: Protivnetni in imunomodulirajoči učinki dimetilfumarata in njegovega presnovka monometilfumarata niso v celoti pojasnjeni, predpostavljajo pa, da do njih prihaja v glavnem zaradi medsebojnega delovanja z medcelično znižanim glutationom celic, ki so neposredno vključene v patogenezo psoriaze.
English: Patients should be made aware that they are likely to experience flushing in the first few weeks of taking Skilarence (see section 4.8).
Slovenian: Bolnike je treba opozoriti, da obstaja velika verjetnost vročinskega oblivanja v prvih tednih jemanja zdravila Skilarence (glejte poglavje 4.8).