natgillin/translations-raw huggingface dataset:
Children and adolescents below the age of 18 years should not take this medicine because it has not been studied in this age group.
Otroci in mladostniki, mlajši od 18 let, tega zdravila ne smejo uporabljati, saj ga v tej starostni skupini niso preučevali.
A risk to newborns or infants cannot be excluded.
Tveganja za dojenega novorojenca ali otroka ne moremo izključiti.
No specific antidote is known.
Specifičen antidot ni znan.
A modified or weakened immune system as well as genetic or environmental factors can also constitute risk factors.
Spremenjen ali oslabljen imunski sistem ter tudi genetski ali okoljski dejavniki lahko prav tako predstavljajo dejavnike tveganja.
You may not need the maximum dose of 720 mg per day.
Morda ne boste potrebovali najvišjega odmerka 720 mg na dan.
How many tablets to take during the day Number of tablets per day
Število tablet, ki jih je treba vzeti tekom dneva Število tablet na dan
9/L or other pathological results are identified.
9/l ali drugi patološki rezultati.
The demographic and baseline characteristics were well balanced between the treatment groups.
Demografski in izhodiščne lastnosti so bile med skupinami zdravljenja dobro uravnotežene.
This helps to reduce stomach problems and other side effects.
To pomaga zmanjšati želodčne težave in druge stranske učinke.
Brain infection called PML
Okužba možganov, imenovana PML
Immunosuppression is a risk factor for the use of live vaccines.
Imunosupresija je dejavnik tveganja za uporabo živih cepiv.
Most patients (91%) were <65 years of age.
Večina bolnikov (91 %) je bila mlajša od 65 let.
White blood cells help your body to fight infections.
Bele krvničke pomagajo pri obrambi vašega telesa pred okužbami.
A previous infection with JCV is considered a prerequisite for the development of PML.
Pretekla okužba z virusom JC se šteje za predpogoj za razvoj PML.
The only adverse reactions that led to discontinuation of treatment in >5% of patients were gastrointestinal reactions.
Edini neželeni učinki, ki so povzročili prekinitev zdravljenja pri > 5 % bolnikov, so bile reakcije v prebavilih.
Dimethyl fumarate works on cells of the immune system (the body's natural defences).
Dimetilfumarat deluje na celice imunskega sistema (naravne obrambne mehanizme telesa).
Non-clinical safety pharmacology and genotoxicity data reveal no special hazard for humans.
Neklinična farmakologija varnosti in podatki o genotoksičnosti ne kažejo na posebno tveganje za ljudi.
Lunch Evening meal
Kosilo Večerni obrok
In particular, tell your doctor if you are taking the following:
Še zlasti obvestite zdravnika, če jemljete naslednja zdravila:
One-sided 97.5% repeated CI (lower limit)
Enostranski ponovljeni 97,5 % IZ (spodnja meja)
Tell your doctor if you have or have had problems with your stomach or intestines.
Obvestite svojega zdravnika, če imate ali če ste imeli težave z želodcem ali črevesjem.
The safety and efficacy of Skilarence in paediatric patients below the age of 18 years have not been established.
Varnost in učinkovitost zdravila Skilarence pri pediatričnih bolnikih, mlajših od 18 let, še nista bili dokazani.
The risk of vaccination should be weighed against the benefit.
Treba je pretehtati tveganje cepljenja v primerjavi z njihovo koristjo.
Summary of clinical efficacy after 16 weeks treatment in Study 1102 Assessment
Preglednica 1: Povzetek klinične učinkovitosti po 16-tedenskem zdravljenju v študiji 1102
In any case blood counts should be monitored until values have returned to the normal range.
V vsakem primeru je treba spremljati krvno sliko, dokler se vrednosti ne vrnejo v običajen razpon.
Certain types of vaccines (live vaccines) may cause infection if used during treatment with Skilarence.
Nekatere vrste cepiv (živa cepiva) lahko povzročijo okužbo, če jih uporabimo med zdravljenjem z zdravilom Skilarence.
It changes the activity of the immune system and reduces the production of substances involved in causing psoriasis.
Spremeni aktivnost imunskega sistema in zmanjša nastajanje snovi, ki povzročajo psoriazo.
Blood sampling for safety clinical laboratory tests at follow-up visits was only performed in case of abnormalities at the preceeding visit.
Vzorčenje krvi za varnostne klinične laboratorijske preiskave ob obiskih za spremljanje so izvedli le v primeru nenormalnih vrednosti ob predhodnem obisku.
Allergic or hypersensitivity reactions are rare but may be very serious.
Alergijske ali preobčutljivostne reakcije so redke, a so lahko zelo resne.
Most adverse reactions were considered mild and did not lead to discontinuation of study treatment.
Večina neželenih učinkov je bilo blagih in niso povzročili prekinitve zdravljenja s študijskim zdravilom.
Psoriasis is a disease causing thickened, inflamed, red areas on the skin, often covered by silvery scales.
Psoriaza je bolezen, ki povzroča odebeljena, vneta, rdeča področja na koži, ki so pogosto pokrita a srebrnkastimi luskami.
You must avoid using other products that contain fumarates to prevent taking too much.
Uporabi drugih zdravil, ki vsebujejo fumarate, se morate izogibati, da boste preprečili prevelik vnos.
Persistent moderate or severe lymphopenia during treatment with dimethyl fumarate is also considered a risk factor for PML.
Vztrajna zmerna ali huda limfopenija med zdravljenjem z dimetilfumaratom se prav tako šteje za dejavnik tveganja za PML.
Your doctor will start your treatment with a low dose (using 30 mg Skilarence tablets).
Zdravnik bo vaše zdravljenje začel z nizkim odmerkom (z uporabo 30 mg tablet zdravila Skilarence).
The frequency of adverse reactions is defined using the following convention: 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); very rare (<1/10,000); and not known (cannot be estimated from available data).
Incidenca spodnjih neželenih učinkov je izražena po naslednjih kategorijah: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
In case of unclear symptoms Fanconi syndrome should be considered and appropriate examinations should be performed.
V primeru nejasnih simptomov je treba pomisliti na Fanconijev sindrom in opraviti ustrezne preiskave.
To improve tolerability, it is recommended to begin treatment with a low initial dose with subsequent gradual increases.
Za izboljšanje prenašanja zdravila je priporočljivo začeti zdravljenje z nizkim začetnim odmerkom z nadaljnjimi postopnimi povečanji.
Allergic or hypersensitivity reactions
Alergijske ali preobčutljivostne reakcije
During treatment a complete blood count with differential should be performed every 3 months.
Med zdravljenjem je treba vsake 3 mesece opraviti oceno celotne krvne slike z diferencialno sliko.
Very common Very common Common Common Very rare Very rare
zelo pogosti zelo pogosti pogosti pogosti zelo redki zelo redki
During treatment with Skilarence, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided.
Med zdravljenjem z zdravilom Skilarence se je treba izogniti sočasni uporabi drugih derivatov fumarne kisline (lokalni ali sistemski).
Do not take Skilarence if you are pregnant or trying to become pregnant, as Skilarence may harm your baby.
Ne jemljite zdravila Skilarence, če ste noseči ali če se trudite zanositi, saj lahko zdravilo Skilarence škoduje vašemu otroku.
PML is an opportunistic infection caused by the John-Cunningham virus (JCV) that can be fatal or cause severe disabilities.
PML je oportunistična okužba, ki jo povzroča virus JC (John Cunninghamov) in ki je lahko smrtna ali pa lahko povzroči hudo prizadetost.
Talk to your doctor if you have bad diarrhoea and are concerned that other medicines you are taking might not work.
Pogovorite se z zdravnikom, če imate hudo drisko in vas skrbi, da druga zdravila, ki jih jemljete, morda ne delujejo.
Pharmacotherapeutic group: Other immunosuppressants, ATC code: L04AX07
Farmakoterapevtska skupina: drugi imunosupresivi, oznaka ATC: L04AX07
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
− Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
If PML is suspected, treatment with Skilarence should be stopped immediately and further appropriate neurological and radiological examinations performed.
Ob sumu na PML je treba zdravljenje z zdravilom Skilarence takoj prekiniti ter opraviti dodatne ustrezne nevrološke in radiološke preiskave.
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.