natgillin/translations-raw huggingface dataset:
Fingolimod blood clearance is 6.32.3 l/h, and the average apparent terminal half-life (t1/2) is 6-9 days. 
Očistek fingolimoda iz krvi je 6,32,3 l/h, povprečen navidezni končni razpolovni čas izločanja (t1/2) je 6-9 dni.
Be sure to tell your doctor about any changes in your vision. 
Zagotovo obvestite zdravnika o vsaki spremembi vida, ki jo opazite.
Otherwise, it may not be possible for the doctor to understand the results of the test, and for certain types of blood test your doctor may need to take more blood than usual. 
V nasprotnem primeru zdravnik ne bo mogel pravilno razumeti izvidov preiskav, za nekatere vrste krvnih preiskav pa vam bodo morali odvzeti več krvi kot običajno.
What is multiple sclerosis 
Kaj je multipla skleroza
After oral administration, about 81% of the dose is slowly excreted in the urine as inactive metabolites. 
Po peroralnem odmerjanju se približno 81 % odmerka počasi izloča z urinom v obliki neaktivnih metabolitov.
This post-dose effect persists over the following days, although usually to a milder extent, and usually abates over the next weeks. 
Ta učinek po odmerjanju traja tudi v naslednjih dneh, čeprav je običajno manj izražen in običajno v naslednjih tednih oslabi.
The macula is a small area of the retina at the back of the eye which enables you to see shapes, colours, and details clearly and sharply. 
Makula je majhen predel mrežnice na očesnem ozadju, ki nam omogoča, da vidimo oblike, barve in podrobnosti jasno in ostro.
- more than 2 weeks after one month of treatment. 
• za več kot 2 tedna po prvem mesecu zdravljenja.
The recommended dose is: 
Priporočeni odmerek:
Although the estimated risk appears to increase with cumulative exposure over time, an exact relationship with the duration of treatment is unknown. 
Čeprav se zdi, da se ocenjeno tveganje s kumulativno izpostavljenostjo zdravilu sčasoma povečuje, natančna povezava s trajanjem zdravljenja ni znana.
Fingolimod is extensively distributed to body tissues with a volume of distribution of about 1,200260 litres. 
Fingolimod se obsežno porazdeli po tkivih v telesu z volumnom porazdelitve približno 1.200260 litrov.
• GILENYA is teratogenic. 
• Zdravilo GILENYA je teratogeno.
Depressed mood 
depresivno razpoloženje
Approximately 15-20% of T lymphocytes have an effector memory phenotype, cells that are important for peripheral immune surveillance. 
Približno 15-20 % limfocitov T ima fenotip efektorskih spominskih celic, ki so pomembne za periferni imunski nadzor.
Inhaled salmeterol has also been shown to have a modest positive chronotropic effect. 
Pokazalo se je, da ima tudi inhaliranje salmeterola zmeren pozitivni kronotropni učinek.
Expanded Disability Status Score (EDSS) was between 0 and 5.5. 
Na razširjeni lestvici statusa invalidnosti (Expanded Disability Status Score - EDSS) so dosegli od 0 do 5,5 točk.
A third study targeting the same adult patient population was completed after registration of Gilenya. 
Tretjo študijo, ki je bila usmerjena na enako populacijo odraslih bolnikov, so zaključili po registraciji zdravila Gilenya.
The following information is particularly important for children and adolescents and their caregivers: - Before you start Gilenya, your doctor will check your vaccination status. 
Za otroke in mladostnike ter njihove negovalce so zlasti pomembne naslednje informacije: - Preden boste začeli jemati zdravilo Gilenya, bo zdravnik preveril vaše stanje cepljenosti.
There are very limited data available in children between 10-12 years old (see sections 4.4, 4.8 and 
O uporabi pri otrocih, starih od 10 do 12 let, je na voljo zelo malo podatkov (glejte poglavja 4.4, 4.8 in
PML is an opportunistic infection caused by John Cunningham virus (JCV), which may be fatal or result in severe disability. 
PML je oportunistična okužba, ki jo povzroča virus John-Cunningham (virus JC) in je lahko smrtna ali povzroči hudo invalidnost.
• Doctors will provide counselling in the event of pregnancy and evaluation of the outcome of any pregnancy. 
• V primeru nosečnosti bodo zdravniki bolnici zagotovili svetovanje in vrednotenje izida katerekoli nosečnosti.
They usually did not require treatment and resolved within the first 24 hours on treatment. 
Običajno zaradi njih ni bilo potrebno zdravljenje, izzvenele pa so v prvih 24 urah zdravljenja.
Posterior reversible encephalopathy syndrome (PRES)* 
sindrom posteriorne reverzibilne encefalopatije (PRES)*
Never take a double dose to make up for a forgotten dose. 
Nikoli ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
• Corticosteroids, due to a possible added effect on the immune system. 
• kortikosteroide, zaradi možnosti dodatnega delovanja na imunski sistem.
Detailed information of adverse reactions with no recommendation should not be included in this section. 
Podrobne informacije o neželenih učinkih, ki ne vsebujejo priporočil, ne smejo biti navedene v tem poglavju.
Gilenya will stay in your body for up to 2 months after you stop taking it. 
Zdravilo Gilenya bo ostalo v vašem telesu še do 2 meseca po tem, ko ga boste prenehali jemati.
The safety and efficacy of Gilenya in children aged below 10 years have not yet been established. 
Varnost in učinkovitost zdravila Gilenya pri otrocih, starih manj kot 10 let, še nista bili dokazani.
If these effects are pronounced, tell your doctor, because you may need treatment right away. 
V primeru, da so navedeni učinki zelo izraženi, obvestite zdravnika, saj morda potrebujete takojšnje zdravljenje.
- more than 7 days during weeks 3 and 4 of treatment. 
• za več kot 7 dni v 3. in 4. tednu zdravljenja,
Both studies included adult patients who had experienced ≥2 relapses in the prior 2 years or ≥1 relapse during the prior year. 
V obe študiji so vključili odrasle bolnike, ki so imeli v predhodnih 2 letih ≥2 zagona ali v predhodnem letu ≥1 zagon.
Not known (frequency cannot be estimated from the available data): - Peripheral swelling 
Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov): - periferne otekline.
o Specific recommendations regarding vaccination for patients initiating GILENYA treatment. 
o Specifična priporočila glede cepljenja za bolnike, ki začenjajo zdravljenje z zdravilom GILENYA.
Clinical experience and pharmacokinetic information in patients aged above 65 years are limited. 
Obseg kliničnih izkušenj in farmakokinetičnih podatkov pri bolnikih, ki so stari več kot 65 let, je omejen.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi bili lahko noseči ali načrtujete nosečnost, se posvetujte z zdravnikom, preden začnete jemati to zdravilo.
There are no data available for paediatric patients below 10 years old. 
Za pediatrične bolnike, ki so stari manj kot 10 let, ni na voljo nobenih podatkov.
Neutrophil count decreased * Not reported in Studies FREEDOMS, FREEDOMS II and TRANSFORMS. 
znižano število nevtrofilcev * O tem sindromu v študijah FREEDOMS, FREEDOMS II in TRANSFORMS niso poročali.
Your doctor will tell you whether your illness allows you to drive vehicles, including a bicycle, and use machines safely. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravnik vam bo povedal, ali vam vaša bolezen dopušča varno vožnjo, tudi vožnjo s kolesom, in uporabo strojev.
After 12 months (month 36), 856 patients (93%) were still enrolled. 
Po 12 mesecih (po 36 mesecih zdravljenja) je v študiji še vedno sodelovalo 856 (93 %) bolnikov.
• Physicians should reassess on an annual basis the benefit of GILENYA treatment versus risk in each patient, especially pediatric patients. 
• Zdravniki morajo enkrat na leto ponovno pretehtati koristi zdravljenja z zdravilom GILENYA v primerjavi s tveganji pri vsakem bolniku, zlasti pri pediatričnih bolnikih.
Other medicines and Gilenya Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo Gilenya Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
During and for up to 2 months after treatment with Gilenya, you should not receive certain types of vaccine (live attenuated vaccines) as they could trigger the infection that they were supposed to prevent. 
V času zdravljenja z zdravilom Gilenya in do 2 meseca po njem ne smete prejeti določenih vrst cepiv (živih atenuiranih cepiv), ker bi lahko sprožila okužbe, ki bi jih morala preprečiti.
It should also be noted that a negative anti-JCV antibody test does not preclude the possibility of subsequent JCV infection. 
Poleg tega je treba opozoriti, da negativen izvid tega testa ne izključuje možnosti naknadne okužbe z virusom JC.
Severe exacerbation of disease after Gilenya discontinuation*** 
hudo poslabšanje bolezni po prekinitvi uporabe zdravila Gilenya***
- Autoimmune form of anaemia (decreased amount of red blood cells) where red blood cells are destroyed (autoimmune haemolytic anaemia). 
- avtoimunska oblika anemije (zmanjšano število rdečih krvnih celic), pri kateri prihaja do razpada rdečih krvnih celic (avtoimunska hemolitična anemija).
Gilenya can be taken with or without food. 
Zdravilo Gilenya je mogoče jemati s hrano ali brez nje.
Fingolimod and fingolimod phosphate are highly protein bound (>99%). 
Fingolimod in fingolimodijev fosfat se v veliki meri vežeta na proteine (>99 %).
84 capsules (3 packs of 28) 
84 kapsul (3 pakiranja po 28)
- Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). 
- bolniki z zelo aktivno boleznijo kljub celotnemu in ustreznemu poteku zdravljenja z najmanj enim zdravilom, ki spreminja potek bolezni (za izjeme in podatke o vmesnih obdobjih brez zdravljenja glejte poglavji 4.4 in 5.1).
PML can only occur in the presence of a JCV infection. 
PML se lahko razvije samo v primeru okužbe z virusom JC.
The majority of patients were Tanner stage 2 or higher (94.4%) and were >40 kg (95.3%). 
Večina bolnikov je imela oceno stopnje razvoja po Tannerju 2 ali več (94,4 %) in telesno maso več kot 40 kg (95,3 %).
Symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain. 
Po koncu zagona lahko simptomi povsem izzvenijo, nekatere težave pa lahko ostanejo.
After 12 months (month 24), 882 patients (86%) were still enrolled. 
Po 12 mesecih (po 24 mesecih zdravljenja) je v študiji še vedno sodelovalo 882 (86 %) bolnikov.
Caution is required in this subgroup population (see “Paediatric population” in section 4.8). 
Pri tej populacijski podskupini je potrebna previdnost (glejte pod naslovom “Pediatrična populacija” v poglavju 4.8).
• Women exposed to GILENYA during pregnancy are encouraged to join the pregnancy exposure registry that monitors outcomes of pregnancy. 
• Ženske, ki so v času nosečnosti izpostavljene zdravilu GILENYA, se spodbuja, da se vključijo v register izpostavljenosti nosečnic, s pomočjo katerega se spremlja izide nosečnosti.
Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation*** 
preobčutljivostne reakcije, vključno z izpuščajem, urtikarijo in angioedemom po začetku zdravljenja***
These cases have been confounded by concomitant medicinal products and/or pre-existing disease. 
V navedenih primerih so bile vpletene tudi sočasna uporaba drugih zdravil in/ali že prej prisotne bolezni.
Your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur. 
Tudi število belih krvnih celic (število limfocitov) lahko v tem času ostane znižano in še vedno lahko pride do neželenih učinkov, ki so opisani v tem navodilu za uporabo.
7 x 1 hard capsule 
7 x 1 trda kapsula
Before you start Gilenya, your doctor will confirm whether you have enough white blood cells in your blood and may want to repeat a check regularly. 
Preden boste začeli zdravljenje z zdravilom Gilenya, bo zdravnik preveril, ali imate v krvi dovolj belih krvnih celic, lahko bo tudi želel, da to preiskavo redno ponavljate.
The possibility of recurrence of exceptionally high disease activity should be considered. 
Upoštevati je treba možnost izjemno visoke aktivnosti bolezni v primeru ponovitve bolezni.
Fingolimod and fingolimod phosphate are not excreted intact in urine but are the major components in the faeces, with amounts representing less than 2.5% of the dose each. 
Fingolimod in fingolimodijev fosfat se ne izločata nespremenjena z urinom, sta pa glavni sestavini tistega dela odmerka, ki se izloči z blatom, pri čemer znaša količina vsake od njiju manj kot 2,5 % odmerka.
Animal studies and in vitro experiments indicate that fingolimod may also act via interaction with S1P receptors on neural cells. 
Rezultati študij na živalih in poskusov in vitro kažejo, da bi lahko deloval tudi prek interakcije z receptorji S1P na živčnih celicah.
To switch from teriflunomide, your doctor may advise you to wait for a certain time or to go through an accelerated elimination procedure. 
Pri prehodu s teriflunomida vam bo zdravnik verjetno svetoval, da z nadaljevanjem zdravljenja nekaj časa počakate ali pa opravite postopek pospešenega izločanja zdravila.
These patients should not receive concomitant phototherapy with UV-B-radiation or PUVA-photochemotherapy. 
Ti bolniki se sočasno ne smejo zdraviti s fototerapijo z ultravijoličnimi žarki B (UV-B) ali s fotokemoterapijo s PUVA.
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA27 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA27
Interference with serological testing 
Vpliv na rezultate seroloških testov
Alemtuzumab has profound and prolonged immunosuppressive effects. 
Alemtuzumab ima izrazit in dolgotrajen imunosupresivni učinek.
The capsules should always be swallowed intact, without opening them. 
Kapsule je treba vedno zaužiti cele in nepoškodovane, ne da bi jih prej odprli.
Your doctor may want you to undergo an eye examination, especially if: - the centre of your vision gets blurry or has shadows; - you develop a blind spot in the centre of your vision; - you have problems seeing colours or fine detail. 
Zdravnik vas bo morda napotil na pregled oči, zlasti če: - postane centralni del vidnega polja zamegljen ali se vam pred očmi pojavljajo sence; - če v centralnem delu vidnega polja opažate slepo pego; - če imate težave z zaznavanjem barv ali podrobnosti.
If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus). 
Če nikoli niste preboleli noric, bo zdravnik pregledal vašo imunost proti virusu, ki povzroča norice (proti virusu varicella zoster).
If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned. 
Če je prekinitev zdravljenja krajša od zgoraj navedenih, je treba z zdravljenjem nadaljevati z naslednjim odmerkom po načrtovanem razporedu.
Least Square Mean # One patient randomised to receive interferon beta-1a by intramuscular injection was unable to swallow the double-dummy medication and discontinued from study. 
povprečje po metodi najmanjših kvadratov # En bolnik, ki je bil randomiziran na prejemanje interferona beta-1a z intramuskularno injekcijo, ni mogel požirati dvojno prikritega zdravila in je prekinil sodelovanje v študiji.
• Cases of seizure, including status epilepticus, have been reported. 
• Poročali so o primerih epileptičnega napada, kar vključuje epileptični status.
A study in four healthy subjects who received a single intravenous dose of a radioiodolabelled analogue of fingolimod demonstrated that fingolimod penetrates into the brain. 
Študija na štirih zdravih prostovoljcih, ki so prejeli enkratni intravenski odmerek radioaktivno označenega analoga fingolimoda, je pokazala, da fingolimod prehaja v možgane.
The pharmacologically active metabolite responsible for efficacy is fingolimod phosphate. 
Farmakološko aktiven metabolit, ki je odgovoren za učinkovitost, je fingolimodijev fosfat.
The swelling usually happens in the first 4 months of Gilenya treatment. 
Do otekanja običajno pride v prvih 4 mesecih zdravljenja z zdravilom Gilenya.
• Patients should ensure medication compliance and avoid misuse, especially treatment interruption, and repeat cardiac monitoring; 
• bolniki morajo jemati zdravilo skladno z navodili in se izogibati nepravilni uporabi zdravila, zlasti v primeru prekinitve zdravljenja, in ponavljati preglede za spremljanja delovanja srca;
Exposure to the sun and protection against the sun Fingolimod weakens your immune system. 
Izpostavljanje sončni svetlobi in zaščita pred soncem Fingolimod zavira delovanje imunskega sistema.
The patient was excluded from the full analysis and safety set. 
Podatki tega bolnika niso vključeni v set podatkov za celotno analizo in oceno varnosti (full analysis and safety set).
Malignant melanoma**** 
maligni melanom****
The pharmacokinetics of fingolimod and fingolimod phosphate do not differ in males and females, in patients of different ethnic origin, or in patients with mild to severe renal impairment. 
Farmakokinetične lastnosti fingolimoda in fingolimodijevega fosfata se ne razlikujejo med moškimi in ženskami, med bolniki različnega etničnega izvora ali pri bolnikih z blago do hudo okvaro ledvic.
Gilenya can pass into breast milk and there is a risk of serious side effects for the baby. 
Zdravilo Gilenya lahko prehaja v materino mleko in obstaja tveganje za resne neželene učinke pri otroku.
Furthermore, the receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis. 
Poleg tega je znano, da je receptor, na katerega vpliva fingolimod (receptor za sfingozin-1-fosfat) vpleten v nastajanje žilja v času embriogeneze.
• Medicines that slow the heartbeat (for example beta blockers, such as atenolol). 
• zdravila, ki upočasnjujejo bitje srca (na primer zaviralci adrenergičnih receptorjev beta, kot je atenolol).
Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: 
Zdravilo Gilenya je indicirano kot samostojna terapija, ki spreminja potek bolezni pri zelo aktivni recidivno-remitentni multipli sklerozi, za naslednji skupini odraslih bolnikov in pediatričnih bolnikov, starih 10 let ali več:
Taking Gilenya at the same time each day will help you remember when to take your medicine. 
Če boste jemali zdravilo Gilenya vsak dan ob istem času, se boste laže spomnili, kdaj morate vzeti zdravilo.
Some cases of disseminated herpes infection, including fatal cases, have been reported even at the 0.5 mg dose. 
O nekaj primerih diseminirane okužbe z virusom herpes simpleks, vključno s smrtnimi primeri, so poročali celo pri uporabi 0,5 mg odmerka.
Pharmacokinetic data were obtained in healthy adult volunteers, in renal transplant adult patients and in multiple sclerosis adult patients. 
Farmakokinetične podatke so pridobivali pri zdravih odraslih prostovoljcih, pri odraslih bolnikih po presaditvi ledvic in pri odraslih bolnikih z multiplo sklerozo.
After 34 days, the recovery of the administered dose is 89%. 
Po 34 dneh je mogoče prestreči 89 % danega odmerka.
Patients with severe lung problems or with smoker's cough may have a higher chance of developing side effects. 
Bolniki, ki imajo hude pljučne težave ali kadilski kašelj, so lahko bolj dovzetni za neželene učinke.
The mechanism of action of bradycardia and vasoconstriction were also studied in vitro in guinea pigs and isolated rabbit aorta and coronary artery. 
Mehanizem delovanja v smislu bradikardije in vazokonstrikcije so proučevali tudi in vitro na budrah in na izolirani kunčji aorti in koronarni arteriji.
Nausea*** 
navzea***
With continued daily dosing, the lymphocyte count continues to decrease over a two-week period, reaching a minimal count of approximately 500 cells/microlitre or approximately 30% of baseline. 
Z nadaljevanjem vsakodnevnega odmerjanja se število limfocitov znižuje še nadaljnja dva tedna in doseže najnižje število približno 500 celic/mikroliter ali približno 30 % izhodiščne vrednosti.
Prior to launch of GILENYA 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 (NCA). 
Pred prihodom zdravila GILENYA na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi drugimi vidiki programa.
Return of disease activity (rebound) after fingolimod discontinuation 
Ponovna aktivacija bolezni (povratni učinek) po prekinitvi uporabe fingolimoda
Food intake does not alter Cmax or exposure (AUC) of fingolimod. 
Uživanje hrane ne vpliva na Cmax ali na izpostavljenost (AUC) fingolimodu.
Before you start treatment with Gilenya your doctor will explain the risk to you and ask you to do a pregnancy test in order to ensure that you are not pregnant. 
Preden boste začeli zdravljenje z zdravilom Gilenya, vam bo zdravnik pojasnil, kakšno je tveganje, in vam naročil, da opravite test nosečnosti, da se prepriča, da niste noseči.
INTERMEDIATE CARTON OF MULTIPACK - WALLET (WITHOUT BLUE BOX) 
VMESNA ŠKATLA SKUPNEGA PAKIRANJA - ZLOŽENKA (BREZ ”BLUE BOX” PODATKOV)
Animal studies have shown that this redistribution reduces the infiltration of pathogenic lymphocytes, including pro-inflammatory Th17 cells, into the CNS, where they would be involved in nerve inflammation and nervous tissue damage. 
Študije na živalih so pokazale, da se zaradi navedene prerazporeditve zmanjša infiltracija patogenih limfocitov, vključno s Th 17 celicami vnetnega odziva, v CŽS, kjer so sicer vpleteni v procese vnetja živcev in poškodb živčnega tkiva.
The majority of T and B lymphocytes regularly traffic through lymphoid organs and these are the cells mainly affected by fingolimod. 
Večina limfocitov T in B praviloma potuje skozi limfatične organe in fingolimod deluje predvsem na te celice.
The relationship of such events to Gilenya is uncertain. 
Povezanost takih dogodkov z zdravilom Gilenya ni zanesljivo opredeljena.
Starting other therapies during this interval will result in concomitant exposure to fingolimod. 
Uvedba drugih zdravil v tem obdobju pomeni sočasno izpostavljenost fingolimodu.
This has generally been observed within 12 weeks after stopping fingolimod, but has also been reported up to 24 weeks after fingolimod discontinuation. 
Tako poslabšanje so praviloma opažali v času 12 tednov po prenehanju jemanja fingolimoda, o njem pa so poročali tudi v času do 24 tednov po prekinitvi uporabe fingolimoda.
Eighteen percent of patients reached a minimal count below 200 cells/microlitre on at least one occasion. 
Pri osemnajstih odstotkih bolnikov je najnižje število limfocitov najmanj enkrat doseglo vrednost pod 200 celic/mikroliter.
Gilenya is not intended for use in children below 10 years old as it has not been studied in MS patients in this age group. 
Zdravilo Gilenya ni namenjeno uporabi pri otrocih, ki so stari manj kot 10 let, saj ga pri bolnikih z multiplo sklerozo v tej starostni skupini niso proučevali.
In patients with severe hepatic impairment (Child-Pugh class C), fingolimodphosphate Cmax was decreased by 22% and AUC was not substantially changed. 
Pri bolnikih s hudo okvaro jeter (Child-Pugh stopnje C) se je Cmax fingolimodijevega fosfata znižala za 22 %, AUC pa se ni bistveno spremenila.