FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of patients were Tanner stage 2 or higher (94.4%) and were >40 kg (95.3%).
Slovenian: Večina bolnikov je imela oceno stopnje razvoja po Tannerju 2 ali več (94,4 %) in telesno maso več kot 40 kg (95,3 %).
English: Symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain.
Slovenian: Po koncu zagona lahko simptomi povsem izzvenijo, nekatere težave pa lahko ostanejo.
English: After 12 months (month 24), 882 patients (86%) were still enrolled.
Slovenian: Po 12 mesecih (po 24 mesecih zdravljenja) je v študiji še vedno sodelovalo 882 (86 %) bolnikov.
English: Caution is required in this subgroup population (see “Paediatric population” in section 4.8).
Slovenian: Pri tej populacijski podskupini je potrebna previdnost (glejte pod naslovom “Pediatrična populacija” v poglavju 4.8).
English: • Women exposed to GILENYA during pregnancy are encouraged to join the pregnancy exposure registry that monitors outcomes of pregnancy.
Slovenian: • 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.
English: Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation***
Slovenian: preobčutljivostne reakcije, vključno z izpuščajem, urtikarijo in angioedemom po začetku zdravljenja***
English: Kaposi's sarcoma****
Slovenian: Kaposijev sarkom****
English: These cases have been confounded by concomitant medicinal products and/or pre-existing disease.
Slovenian: V navedenih primerih so bile vpletene tudi sočasna uporaba drugih zdravil in/ali že prej prisotne bolezni.
English: 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.
Slovenian: 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.
English: 7 x 1 hard capsule
Slovenian: 7 x 1 trda kapsula
English: 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.
Slovenian: 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.
English: The possibility of recurrence of exceptionally high disease activity should be considered.
Slovenian: Upoštevati je treba možnost izjemno visoke aktivnosti bolezni v primeru ponovitve bolezni.
English: 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.
Slovenian: 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.
English: Animal studies and in vitro experiments indicate that fingolimod may also act via interaction with S1P receptors on neural cells.
Slovenian: Rezultati študij na živalih in poskusov in vitro kažejo, da bi lahko deloval tudi prek interakcije z receptorji S1P na živčnih celicah.
English: To switch from teriflunomide, your doctor may advise you to wait for a certain time or to go through an accelerated elimination procedure.
Slovenian: Pri prehodu s teriflunomida vam bo zdravnik verjetno svetoval, da z nadaljevanjem zdravljenja nekaj časa počakate ali pa opravite postopek pospešenega izločanja zdravila.
English: These patients should not receive concomitant phototherapy with UV-B-radiation or PUVA-photochemotherapy.
Slovenian: Ti bolniki se sočasno ne smejo zdraviti s fototerapijo z ultravijoličnimi žarki B (UV-B) ali s fotokemoterapijo s PUVA.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA27
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA27
English: Interference with serological testing
Slovenian: Vpliv na rezultate seroloških testov
English: Alemtuzumab has profound and prolonged immunosuppressive effects.
Slovenian: Alemtuzumab ima izrazit in dolgotrajen imunosupresivni učinek.
English: The capsules should always be swallowed intact, without opening them.
Slovenian: Kapsule je treba vedno zaužiti cele in nepoškodovane, ne da bi jih prej odprli.
English: 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.
Slovenian: 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.
English: If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus).
Slovenian: Če nikoli niste preboleli noric, bo zdravnik pregledal vašo imunost proti virusu, ki povzroča norice (proti virusu varicella zoster).
English: If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned.
Slovenian: Če je prekinitev zdravljenja krajša od zgoraj navedenih, je treba z zdravljenjem nadaljevati z naslednjim odmerkom po načrtovanem razporedu.
English: 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.
Slovenian: 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.
English: • Cases of seizure, including status epilepticus, have been reported.
Slovenian: • Poročali so o primerih epileptičnega napada, kar vključuje epileptični status.
English: 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.
Slovenian: Študija na štirih zdravih prostovoljcih, ki so prejeli enkratni intravenski odmerek radioaktivno označenega analoga fingolimoda, je pokazala, da fingolimod prehaja v možgane.
English: The pharmacologically active metabolite responsible for efficacy is fingolimod phosphate.
Slovenian: Farmakološko aktiven metabolit, ki je odgovoren za učinkovitost, je fingolimodijev fosfat.
English: The swelling usually happens in the first 4 months of Gilenya treatment.
Slovenian: Do otekanja običajno pride v prvih 4 mesecih zdravljenja z zdravilom Gilenya.
English: • Patients should ensure medication compliance and avoid misuse, especially treatment interruption, and repeat cardiac monitoring;
Slovenian: • 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;
English: Exposure to the sun and protection against the sun Fingolimod weakens your immune system.
Slovenian: Izpostavljanje sončni svetlobi in zaščita pred soncem Fingolimod zavira delovanje imunskega sistema.
English: The patient was excluded from the full analysis and safety set.
Slovenian: Podatki tega bolnika niso vključeni v set podatkov za celotno analizo in oceno varnosti (full analysis and safety set).
English: Malignant melanoma****
Slovenian: maligni melanom****
English: 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.
Slovenian: 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.
English: Gilenya can pass into breast milk and there is a risk of serious side effects for the baby.
Slovenian: Zdravilo Gilenya lahko prehaja v materino mleko in obstaja tveganje za resne neželene učinke pri otroku.
English: Furthermore, the receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis.
Slovenian: Poleg tega je znano, da je receptor, na katerega vpliva fingolimod (receptor za sfingozin-1-fosfat) vpleten v nastajanje žilja v času embriogeneze.
English: • Medicines that slow the heartbeat (for example beta blockers, such as atenolol).
Slovenian: • zdravila, ki upočasnjujejo bitje srca (na primer zaviralci adrenergičnih receptorjev beta, kot je atenolol).
English: 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:
Slovenian: 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:
English: Taking Gilenya at the same time each day will help you remember when to take your medicine.
Slovenian: Če boste jemali zdravilo Gilenya vsak dan ob istem času, se boste laže spomnili, kdaj morate vzeti zdravilo.
English: Some cases of disseminated herpes infection, including fatal cases, have been reported even at the 0.5 mg dose.
Slovenian: O nekaj primerih diseminirane okužbe z virusom herpes simpleks, vključno s smrtnimi primeri, so poročali celo pri uporabi 0,5 mg odmerka.
English: Pharmacokinetic data were obtained in healthy adult volunteers, in renal transplant adult patients and in multiple sclerosis adult patients.
Slovenian: Farmakokinetične podatke so pridobivali pri zdravih odraslih prostovoljcih, pri odraslih bolnikih po presaditvi ledvic in pri odraslih bolnikih z multiplo sklerozo.
English: After 34 days, the recovery of the administered dose is 89%.
Slovenian: Po 34 dneh je mogoče prestreči 89 % danega odmerka.
English: Patients with severe lung problems or with smoker's cough may have a higher chance of developing side effects.
Slovenian: Bolniki, ki imajo hude pljučne težave ali kadilski kašelj, so lahko bolj dovzetni za neželene učinke.
English: The mechanism of action of bradycardia and vasoconstriction were also studied in vitro in guinea pigs and isolated rabbit aorta and coronary artery.
Slovenian: Mehanizem delovanja v smislu bradikardije in vazokonstrikcije so proučevali tudi in vitro na budrah in na izolirani kunčji aorti in koronarni arteriji.
English: Nausea***
Slovenian: navzea***
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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.
English: Return of disease activity (rebound) after fingolimod discontinuation
Slovenian: Ponovna aktivacija bolezni (povratni učinek) po prekinitvi uporabe fingolimoda
English: Food intake does not alter Cmax or exposure (AUC) of fingolimod.
Slovenian: Uživanje hrane ne vpliva na Cmax ali na izpostavljenost (AUC) fingolimodu.
English: 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.
Slovenian: 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.
English: INTERMEDIATE CARTON OF MULTIPACK - WALLET (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA SKUPNEGA PAKIRANJA - ZLOŽENKA (BREZ ”BLUE BOX” PODATKOV)
English: 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.
Slovenian: 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.
English: The majority of T and B lymphocytes regularly traffic through lymphoid organs and these are the cells mainly affected by fingolimod.
Slovenian: Večina limfocitov T in B praviloma potuje skozi limfatične organe in fingolimod deluje predvsem na te celice.
English: The relationship of such events to Gilenya is uncertain.
Slovenian: Povezanost takih dogodkov z zdravilom Gilenya ni zanesljivo opredeljena.
English: Starting other therapies during this interval will result in concomitant exposure to fingolimod.
Slovenian: Uvedba drugih zdravil v tem obdobju pomeni sočasno izpostavljenost fingolimodu.
English: This has generally been observed within 12 weeks after stopping fingolimod, but has also been reported up to 24 weeks after fingolimod discontinuation.
Slovenian: 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.
English: Eighteen percent of patients reached a minimal count below 200 cells/microlitre on at least one occasion.
Slovenian: Pri osemnajstih odstotkih bolnikov je najnižje število limfocitov najmanj enkrat doseglo vrednost pod 200 celic/mikroliter.
English: 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.
Slovenian: 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.
English: In patients with severe hepatic impairment (Child-Pugh class C), fingolimodphosphate Cmax was decreased by 22% and AUC was not substantially changed.
Slovenian: Pri bolnikih s hudo okvaro jeter (Child-Pugh stopnje C) se je Cmax fingolimodijevega fosfata znižala za 22 %, AUC pa se ni bistveno spremenila.
English: Fingolimod phosphate binds at low nanomolar concentrations to sphingosine 1-phosphate (S1P) receptor 1 located on lymphocytes, and readily crosses the blood-brain barrier to bind to S1P receptor 1 located on neural cells in the central nervous system (CNS).
Slovenian: Fingolimodijev fosfat se v nizkih nanomolarnih koncentracijah veže na receptor 1 za sfingozin-1-fosfat (S1P), ki je na limfocitih, in z lahkoto prehaja krvno-možgansko pregrado ter se veže na receptor 1 za S1P, ki je na živčnih celicah v centralnem živčnem sistemu (CŽS).
English: • Doctors will provide counselling before treatment initiation and regularly thereafter regarding the teratogenic risk of GILENYA and required actions to minimise this risk.
Slovenian: • Zdravnik bo bolnicam pred začetkom zdravljenja in tudi kasneje redno svetoval glede tveganja za teratogeno delovanje zdravila GILENYA in ukrepov, ki jih je treba izvajati za zmanjševanje tveganja.
English: Within 4-6 hours after the first dose of fingolimod 0.5 mg, the lymphocyte count decreases to approximately 75% of baseline in peripheral blood.
Slovenian: V 4-6 urah po prvem odmerku 0,5 mg fingolimoda se število limfocitov v periferni krvi zniža na približno 75 % izhodiščne vrednosti.
English: As the actual duration of these effects is unknown, initiating treatment with Gilenya after alemtuzumab is not recommended unless the benefits of such treatment clearly outweigh the risks for the individual patient.
Slovenian: Dejansko trajanje tega učinka ni znano, zato po zdravljenju z alemtuzumabom ni priporočeno začeti zdravljenja z zdravilom Gilenya, razen če koristi takega zdravljenja nedvomno presegajo tveganja pri posameznem bolniku.
English: Due to the potential for serious adverse reactions to fingolimod in nursing infants, women receiving Gilenya should not breastfeed.
Slovenian: Zaradi možnosti, da pride do resnih neželenih učinkov fingolimoda na dojene otroke, ženske, ki prejemajo zdravilo Gilenya, ne smejo dojiti.
English: Data from preclinical studies do not suggest that fingolimod would be associated with an increased risk of reduced fertility (see section 5.3).
Slovenian: Podatki iz predkliničnih študij ne kažejo, da bi fingolimod lahko povečal tveganje za zmanjšano plodnost (glejte poglavje 5.3).
English: Fingolimod is unlikely to interact with substances mainly cleared by the CYP450 enzymes or by substrates of the main transporter proteins.
Slovenian: Le malo verjetno je, da bi prišlo do interakcij med fingolimodom in učinkovinami, ki se večinoma presnavljajo z encimi CYP450, ali substrati poglavitnih transportnih proteinov.
English: o GILENYA must be stopped 2 months before planning a pregnancy.
Slovenian: o Z jemanjem zdravila GILENYA je treba prenehati 2 meseca pred načrtovanjem nosečnosti.
English: Gilenya has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Gilenya nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: It is contraindicated in women of childbearing potential (including female adolescents) not using effective contraception and in pregnant women.
Slovenian: Kontraindicirano je pri ženskah v rodni dobi (vključno z mladostnicami), ki ne uporabljajo učinkovite kontracepcije, in pri nosečnicah.
English: These measures must be implemented before fingolimod is prescribed to female patients and during treatment.
Slovenian: Gre za ukrepe, ki jih je treba izvajati pred predpisovanjem fingolimoda bolnicam in med samim zdravljenjem.
English: If you have questions about how long to take Gilenya, talk to your doctor or your pharmacist.
Slovenian: Če vas zanima, kako dolgo je treba jemati zdravilo Gilenya, se pogovorite z zdravnikom ali farmacevtom.
English: Use of immunosuppressants soon after the discontinuation of Gilenya may lead to an additive effect on the immune system and caution is therefore indicated.
Slovenian: Pri uporabi imunosupresivov kmalu po prekinitvi jemanja zdravila Gilenya lahko pride do aditivnega učinka na imunski sistem, zato je pri tem potrebna previdnost.
English: • Physicians should assess Tanner staging and measure height and weight as per standard of care;
Slovenian: • zdravniki morajo ocenjevati stopnjo razvoja po Tannerju in meriti telesno višino ter telesno maso bolnikov v skladu s standardno zdravstveno oskrbo;
English: Fingolimod can induce bradycardia upon treatment initiation.
Slovenian: Fingolimod lahko po začetku zdravljenja sproži bradikardijo.
English: Merkel cell carcinoma*** Blood and lymphatic system disorders Common:
Slovenian: karcinom Merklovih celic*** Bolezni krvi in limfatičnega sistema pogosti:
English: Subjects on fingolimod treatment have a normal bronchodilator response to inhaled beta-agonists.
Slovenian: Osebe, ki se zdravijo s fingolimodom imajo normalen bronhodilatatorni odziv na inhalacijske agoniste adrenergičnih receptorjev beta.
English: Progressive multifocal leukoencephalopathy (PML)** Cryptococcal infections** Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common:
Slovenian: progresivna multifokalna levkoencefalopatija (PML)** kriptokokne okužbe** Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) pogosti:
English: Assessments of CBC are also recommended periodically during treatment, at month 3 and at least yearly thereafter, and in case of signs of infection.
Slovenian: Hemogram je priporočeno pregledovati periodično med zdravljenjem, in sicer po 3 mesecih, nato pa najmanj enkrat na leto, ter v primeru znakov okužbe.
English: It was concluded that bradycardia could be mediated primarily by activation of inward-rectifying potassium channel or G-protein activated inwardly rectifying K
Slovenian: Ugotovili so, da bi bradikardijo lahko posredovala predvsem aktivacija navznoter usmerjevalnega kalijevega kanalčka (inward-rectifying potassium channel, IKACh) ali z G-proteinom aktiviranega navznoter usmerjevalnega kalijevega kanalčka (G-protein activated inwardly rectifying K
English: Autoimmune haemolytic anaemia*** Peripheral oedema***
Slovenian: avtoimunska hemolitična anemija*** periferni edem***
English: The MAH shall ensure that in each Member State (MS) where GILENYA is marketed, all physicians who intend to prescribe GILENYA are provided with an updated Physician Information Pack, including:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer je zdravilo GILENYA na trgu, vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo GILENYA, prejeli posodobljen paket izobraževalnih gradiv za zdravnike, ki bo vseboval:
English: Infections could be serious and life-threatening.
Slovenian: Lahko pride tudi do resnih in smrtno nevarnih okužb.
English: • Stopping GILENYA therapy may result in return of disease activity.
Slovenian: • Prekinitev zdravljenja z zdravilom GILENYA lahko povzroči ponovno aktivacijo bolezni.
English: Physicians should carefully monitor patients, especially those with concurrent conditions or known factors, such as previous immunosuppressive therapy.
Slovenian: Zdravniki morajo skrbno spremljati bolnike, zlasti tiste s sočasno prisotnimi drugimi boleznimi ali znanimi dejavniki, kot je predhodno imunosupresivno zdravljenje.
English: Pooled results of Studies D2301 and D2302 showed a consistent and statistically significant reduction in annualised relapse rate compared to comparator in subgroups defined by gender, age, prior multiple sclerosis therapy, disease activity or disability levels at baseline.
Slovenian: Združeni rezultati študij D2301 in D2302 so enotno in s statistično značilnostjo pokazali zmanjšanje na leto preračunane pogostnosti zagonov v primerjavi z uporabo primerjalnega zdravila oziroma placeba, in sicer v podskupinah po spolu, starosti, predhodnem zdravljenju multiple skleroze, aktivnosti bolezni in stopnji invalidnosti ob izhodišču.
English: Gilenya can also cause an irregular heartbeat, especially after the first dose.
Slovenian: Zdravilo Gilenya lahko povzroča tudi nepravilno bitje srca, zlasti po prvem odmerku.
English: - Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
Slovenian: - Bolniki s povečanim tveganjem za oportunistične okužbe, vključno z bolniki z oslabljenim imunskim odzivom (tudi bolniki, ki v tem času prejemajo imunosupresivna zdravila ali imajo oslabljen imunski odziv zaradi predhodnega zdravljenja).
English: On the basis of the scientific conclusions for fingolimod the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing fingolimod is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za fingolimod odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) fingolimodnespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.