natgillin/translations-raw huggingface dataset:
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).
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.
Nekateri od teh neželenih učinkov, kot so npr. pordelost obraza ali telesa (zardevanje), driska, želodčne težave in slabost, se običajno izboljšajo v nadaljevanju zdravljenja.
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).
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).
Proteinuria* Renal failure* Fanconi syndrome*
Bolezni sečil proteinurija* odpoved ledvic* Fanconijev sindrom*
Rare side effects (may affect up to 1 in 1,000 people): - allergic skin reaction
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - alergične reakcije na koži
What you need to know before you take Skilarence
Kaj morate vedeti, preden boste vzeli zdravilo Skilarence
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
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
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).
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).
Symptoms include fever, pain, aching muscles, headache, loss of appetite and a general feeling of weakness.
Simptomi vključujejo povišano telesno temperaturo, bolečine, boleče mišice, glavobol, izgubo teka in splošen občutek šibkosti.
Further metabolism occurs through oxidation via the tricarboxylic acid cycle forming carbon dioxide and water.
Nadaljnja presnova poteka z oksidacijo prek cikla trikarboksilne kisline, pri čemer nastajata ogljikov dioksid in voda.
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).
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).
If you are affected, be careful when driving or using machines.
Če se ti učinki pojavijo pri vas, bodite pri upravljanju vozil in strojev previdni.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Zdravilo Skilarence vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni 'brez natrija'.
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.
Po klinično pomembnem izboljšanju kožnih lezij je treba razmisliti o postopnem zmanjšanju dnevnega odmerka zdravila Skilarence do vzdrževalnega odmerka, ki ga potrebuje posameznik.
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.
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.
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).
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).
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.
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.
Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets.
Velikosti pakiranj: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 in 400 gastrorezistentnih tablet.
Prior to initiating treatment with Skilarence, a current complete blood count (including differential blood count and platelet count) should be available.
Pred uvedbo zdravljenja z zdravilom Skilarence mora biti na voljo trenutna celotna krvna slika (vključno z diferencialno krvno sliko in številom trombocitov).
Patients developing lymphopenia should be monitored after stopping treatment until their lymphocyte count has returned to the normal range (see section 4.8).
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).
Skilarence tablets must be swallowed whole with fluid during or immediately after a meal.
Tablete zdravila Skilarence je treba pogoltniti cele s tekočino med jedjo ali takoj po jedi.
It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk.
Ni znano, ali se dimetilfumarat ali njegovi presnovki izločajo v materino mleko.
3/279 (1.1%) of the patients started on Skilarence.
9/l, kar predstavlja 3/279 (1,1 %) bolnike, pri katerih je bilo uvedeno zdravljenje z zdravilom Skilarence.
• 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
• 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
These medicines taken together with Skilarence could increase the risk of side effects on your kidneys.
Jemanje teh zdravil skupaj z zdravilom Skilarence bi lahko povečalo tveganje za pojav stranskih učinkov na vaše ledvice.
Vaccination during treatment with Skilarence has not been studied.
Cepljenja med zdravljenjem z zdravilom Skilarence niso preučevali.
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.
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.
Patients should be made aware that they are likely to experience flushing in the first few weeks of taking Skilarence (see section 4.8).
Bolnike je treba opozoriti, da obstaja velika verjetnost vročinskega oblivanja v prvih tednih jemanja zdravila Skilarence (glejte poglavje 4.8).
Do not take Skilarence - if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6) - if you have severe problems with your stomach or intestines - if you have severe liver or kidney problems - if you are pregnant or breast-feeding
Ne jemljite zdravila Skilarence - če ste alergični na dimetilfumarat ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate hude težave z želodcem ali prebavili;
The tablets are packed in PVC/PVDC-aluminium blisters.
Tablete so pakirane v pretisne omote iz PVC/PVDC-aluminija.
At week 16, patients treated with Skilarence had a lower mean DLQI compared to placebo (5.4 vs 8.8).
V 16. tednu so imeli bolniki, zdravljeni z zdravilom Skilarence, v primerjavi s placebom nižji povprečni DLQI (5,4 v primerjavi z 8,8).
Skilarence 30 mg is available in packs containing 42, 70 and 210 gastro-resistant tablets.
Zdravilo Skilarence 30 mg je na voljo v pakiranjih, ki vsebujejo 42, 70 in 210 gastrorezistentnih tablet.
Further studies have shown that dimethyl fumarate (and to a lesser extent monomethyl fumarate) reacts partially with reduced glutathione forming a glutathioneadduct.
Dodatne študije so pokazale, da dimetilfumarat (in v manjši meri monometilfumarat) deloma reagira z znižanim glutationom in tvori adukt glutationa.
Skilarence is a medicine that contains the active substance dimethyl fumarate.
Skilarence je zdravilo, ki vsebuje učinkovino dimetilfumarat.
- Pregnancy and breast-feeding.
− Nosečnost in dojenje.
Skilarence may reduce the number of your white blood cells.
Zdravilo Skilarence lahko zmanjša število belih krvničk pri vas.
The main activity of dimethyl fumarate and monomethyl fumarate is considered to be immunomodulatory, resulting in a shift in T helper cells (Th) from the Th1 and Th17 profile to a Th2 phenotype.
Glavna aktivnost dimetilfumarata in monometilfumarata naj bi bila imunomodulacijska, ki povzroča premik T-celic pomagalk (Th) s profila Th1 in Th17 v fenotip Th2.
For patients with pre-existing infections of clinical relevance, the physician should decide if treatment with Skilarence should only be initiated once the infection has resolved.
Pri bolnikih z obstoječimi klinično pomembnimi okužbami se mora zdravnik odločiti, ali se lahko zdravljenje z zdravilom Skilarence uvede šele, ko okužba mine.
If you have a serious infection, either before starting treatment with Skilarence or during treatment, your doctor may advise you not to take Skilarence until the infection has resolved.
Če imate resno okužbo, ki se pojavi pred uvedbo zdravljenja z zdravilom Skilarence ali med njim, vam bo zdravnik morda svetoval, da zdravila Skilarence ne jemljete, dokler okužba ne izzveni.
Your dose will be increased every week as shown in the table below (switching to 120 mg Skilarence tablets from week 4 onwards).
Vaš odmerek bo vsak teden povečal, kot je prikazano v spodnji preglednici (prehod na 120 mg tablete zdravila Skilarence od 4. tedna dalje).
704 patients were randomised to receive Skilarence, an active comparator (Fumaderm, a combination product with the same content of dimethyl fumarate plus 3 monoethyl fumarate salts) and placebo in a ratio of 2:2:1.
704 bolnikov je bilo randomiziranih za prejemanje zdravila Skilarence, aktivne primerjave (zdravilo Fumaderm, kombinirano zdravilo z enako vsebnostjo dimetilfumarata in s 3 monometilnimi fumaratnimi solmi) in placeba, v razmerju 2:2:1.
The inflammatory cytokine production is reduced with induction of proapoptotic events, inhibition of keratinocyte proliferation, reduced expression of adhesion molecules, and diminished inflammatory infiltrate within psoriatic plaques.
Nastajanje provnetnih citokinov se zmanjša z induciranjem proapoptotičnih dogodkov, inhibicijo proliferacije keratinocitov, zmanjšanim izražanjem adhezijskih molekul in zmanjšanim vnetnim infiltratom v psoriatičnih plakih.
In vitro studies have shown that hydrolysis of dimethyl fumarate to monomethyl fumarate occurs rapidly at pH 8 (pH in the small intestine), but not at pH 1 (pH in the stomach).
Študije in vitro so pokazale, da hidroliza dimetilfumarata v monometilfumarat hitro poteče pri pH 8 (pH v tankem črevesju), ne pa pri pH 1 (pH v želodcu).
Gastrointestinal tolerability can be improved by following the dose titration schedule on initiating Skilarence treatment and by taking Skilarence with food (see sections 4.2 and 4.8).
Prenašanje v prebavilih je mogoče izboljšati z upoštevanjem načrta za titracijo ob začetku zdravljenja z zdravilom Skilarence in z jemanjem zdravila Skilarence skupaj s hrano (glejte poglavji 4.2 in 4.8).
Diarrhoea was a common adverse reaction (36.9%) among patients taking Skilarence, leading to medicinal product withdrawal in about 10% of patients.
Diareja je bila pri bolnikih, ki so jemali zdravilo Skilarence, pogost neželeni učinek (36,9 %) in je povzročila opustitev jemanja zdravila pri približno 10 % bolnikov.
Avoid strong alcoholic drinks (more than 50 ml of spirits containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol can interact with this medicine.
Med zdravljenjem z zdravilom Skilarence se izogibajte uživanju močnih alkoholnih pijač (več kot 50 ml žgane pijače, ki vsebuje več kot 30 volumskih odstotkov alkohola), saj lahko alkohol medsebojno deluje s tem zdravilom.
There are no data available with Skilarence in paediatric patients.
Podatkov o uporabi zdravila Skilarence pri pediatričnih bolnikih ni na voljo.
If the side effects are not troublesome, your dose will be increased until your condition is well controlled.
Če neželeni učinki ne bodo povzročali težav, bo vaš odmerek povečeval, dokler vaša bolezen ne bo zadostno nadzorovana.
The coating of the gastro-resistant tablets is designed to prevent gastric irritation.
Obloga gastrorezistentnih tablet je zasnovana za preprečevanje draženja črevesja.
The objectives of the educational programme are to inform health care professionals about the risk of serious infections, mainly opportunistic infections such as progressive multifocal leukoencephalopathy (PML), and to provide guidance on the monitoring of lymphocyte and leukocyte count abnormalities.
Cilji izobraževalnega programa so obveščanje zdravstvenih delavcev o tveganjih resnih okužb, zlasti oportunističnih okužb, kot je progresivna multifokalna levkoencefalopatija (PML), in posredovanje smernic za spremljanje nenormalnih vrednosti limfocitov in levkocitov.
There was a trend in the efficacy endpoint PASI score mean % change from baseline, indicating the onset of a clinical response to Skilarence as early as week 3 (-11.8%) which became statistically significant compared to placebo by week 8 (-30.9%).
Opazili so trend v primarnem opazovanem dogodku učinkovitosti - spremembo povprečne ocene PASI v % od izhodišča, kar kaže na nastop kliničnega odziva na zdravilo Skilarence že v 3. tednu (-11,8 %), ki je do 8. tedna postal statistično pomemben v primerjavi s placebom (-30,9 %).