FrancophonIA/ELRC3.0 huggingface dataset:
English: In such patients, treatment with siponimod should be considered only if the anticipated benefits outweigh the potential risks.
Slovenian: Pri takih bolnikih se o zdravljenju s siponimodom sme razmisliti samo v primeru, da pričakovane koristi presegajo možna tveganja.
English: A decision on whether or not siponimod should be re-initiated after resolution needs to take into account the potential benefits and risks for the individual patient.
Slovenian: Pri odločanju glede ponovne uvedbe zdravljenja s siponimodom po izzvenetju makularnega edema je treba upoštevati možne koristi in tveganja za posameznega bolnika.
English: If the overdose constitutes first exposure to siponimod or occurs during the dose titration phase of siponimod it is important to observe for signs and symptoms of bradycardia, which could include overnight monitoring.
Slovenian: Če do prevelikega odmerjanja pride pri prvi izpostavljenosti siponimodu ali v fazi titriranja odmerka siponimoda, je pomembno bolnika opazovati glede znakov in simptomov bradikardije, kar lahko vključuje opazovanje preko noči.
English: • If siponimod is discontinued, the possibility of recurrence of high disease activity should be considered.
Slovenian: • V primeru prekinitve zdravljenja s siponimodom je treba upoštevati možnost ponovitve visoke aktivnosti bolezni.
English: The siponimod fraction found in plasma is 68% in humans.
Slovenian: Pri ljudeh je izmerjena frakcija siponimoda v plazmi 68 %.
English: The differences in T2 lesion volume change and in percentage of brain volume change (average over months 12 and 24) compared to placebo were -1163 mm
Slovenian: Razlika v spremembi velikosti lezij T2 v primerjavi s placebom (povprečja vrednosti po 12 oziroma po 24 mesecih) je bila -1163 mm
English: • fluconazole and certain other medicines can increase the levels of Mayzent in the blood and are not recommended to be taken in combination with Mayzent.
Slovenian: • flukonazol in nekatera druga zdravila lahko zvišajo koncentracijo zdravila Mayzent v krvi in jih ni priporočeno jemati v kombinaciji z zdravilom Mayzent.
English: The study involved randomisation of 1,651 patients to either siponimod 2 mg (N=1,105) or placebo (N=546); 82% of patients treated with siponimod and 78% of placebo-treated patients completed the study.
Slovenian: Študija je vključevala randomizacijo 1.651 bolnikov, tako da so prejemali bodisi siponimod 2 mg (N=1.105) ali placebo (N=546); študijo je zaključilo 82 % bolnikov, ki so prejemali siponimod, in 78 % tistih bolnikov, ki so prejemali placebo.
English: • medicines for an irregular heartbeat, such as amiodarone, procainamide, quinidine or sotalol.
Slovenian: • zdravila za nepravilen srčni ritem, kot so amjodaron, prokainamid, kinidin in sotalol.
English: Siponimod should be used with caution in the elderly due to insufficient data on safety and efficacy (see section 5.2).
Slovenian: Pri starostnikih je pri uporabi siponimoda potrebna previdnost zaradi nezadostnih podatkov o varnosti in učinkovitosti zdravila (glejte poglavje 5.2).
English: Due to its functional antagonism at S1P1 receptors, initial titration of siponimod successively desensitises GIRK channels until the maintenance dose is reached.
Slovenian: Zaradi funkcionalnega antagonizma na receptorjih S1P1 lahko začetna titracija siponimoda sčasoma densenzibilizira kanalčke GIRK, dokler ni dosežen vzdrževalni odmerek.
English: When switching from other disease-modifying therapies, the half-life and mode of action of the other therapy must be considered to avoid an additive immune effect whilst at the same time minimising the risk of disease reactivation.
Slovenian: Pri prehodu z zdravljenja z drugimi zdravili, ki spreminjajo potek bolezni, je treba upoštevati razpolovni čas in način delovanja drugega zdravila, da ne bi pri prišlo do aditivnega delovanja na imunski sistem in da bi hkrati kar najbolj zmanjšali tveganje za reaktivacijo bolezni.
English: Extended observation (>6 hours after first dose): o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose, extend heart rate monitoring for at least 2 more hours and until the heart rate increases again.
Slovenian: Podaljšano opazovanje (>6 ur po prejemu prvega odmerka): o Če srčna frekvenca po 6 urah doseže najnižjo vrednost po prejemu prvega odmerka, je treba spremljanje podaljšati za najmanj 2 uri in do zvišanja srčne frekvence.
English: Your doctor will need to prescribe a new titration pack and you will have to restart treatment at day 1.
Slovenian: Zdravnik vam bo moral predpisati novo titracijsko pakiranje in ponovno boste morali začeti z odmerkom za 1. dan.
English: Your doctor may refer you to a heart specialist, as your medicines may need to be changed because Mayzent may also slow down your heartbeat in the first days of treatment.
Slovenian: Zdravnik se bo morda odločil, da vas napoti k specialistu za srce (kardiologu), saj vam bo treba morda prilagoditi odmerjanje drugih zdravil, ker zdravilo Mayzent v prvih dneh zdravljenja prav tako lahko upočasnjuje srčni utrip.
English: • Doctors will provide counselling before treatment initiation and regularly thereafter regarding the potential teratogenic risk of siponimod and required actions to minimise this risk.
Slovenian: • Zdravnik bo bolnicam pred začetkom zdravljenja in tudi kasneje redno svetoval glede možnega tveganja za teratogeno delovanje siponimoda in ukrepov, ki jih je treba izvajati za zmanjševanje tega tveganja.
English: Table 2 Tabulated list of adverse reactions
Slovenian: Preglednica 2 Tabelarični seznam neželenih učinkov
English: Siponimod treatment with single or multiple doses for 28 days is not associated with clinically relevant increases in airway resistance as measured by forced expiratory volume in 1 second (FEV1) and forced expiratory flow (FEF) during expiration of 25 to 75% of the forced vital capacity (FEF25-75%).
Slovenian: Zdravljenje z enkratnim ali večkratnim odmerjanjem siponimoda 28 dni ni bilo povezano s klinično pomembnim povečanjem upora v dihalnih poteh glede na izmerjene vrednosti forsiranega ekspiracijskega volumna v prvi sekundi (FEV1) in pretoka zraka med forsiranim izdihom (forced expiratory flow, FEF) pri izdihovanje 25 do 75 % forsirane vitalne kapacitete (FEF25-75%).
English: - Immunodeficiency syndrome.
Slovenian: - Sindrom imunske pomanjkljivosti.
English: • Do not initiate siponimod treatment in patients with severe active infection until infection is resolved.
Slovenian: • Bolnikom z aktivno hudo okužbo ne uvajajte zdravljenja s siponimodom, dokler ni okužba odpravljena.
English: - Severe liver impairment (Child-Pugh class C).
Slovenian: - Huda okvara jeter (Child-Pugh stopnje C).
English: - During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6).
Slovenian: - V času nosečnosti in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (glejte poglavji 4.4 in 4.6).
English: • if you have high blood pressure that cannot be controlled by medicines.
Slovenian: • če imate visok krvni tlak, ki ga ni mogoče uravnati z zdravili: potrebne bodo redne meritve krvnega tlaka.
English: If it is almost time for your next dose, skip the missed dose and continue as usual.
Slovenian: Če je že skoraj čas za naslednji odmerek, preskočite izpuščeni odmerek in nadaljujte z jemanjem zdravila po običajnem urniku.
English: Siponimod readily crosses the blood-brain barrier.
Slovenian: Siponimod z lahkoto prehaja hematoencefalno bariero.
English: Starting other therapies during this interval will result in concomitant exposure to siponimod.
Slovenian: Uvedba drugih zdravil v tem obdobju pomeni sočasno izpostavljenost siponimodu.
English: • Patients should be informed about the risk of skin malignancies while on treatment with siponimod and should be cautioned against exposure to sunlight without protection.
Slovenian: • Bolnike je treba obvestiti o tveganju za kožnega raka v času zdravljenja s siponimodom in jih opozoriti, naj se brez zaščite ne izpostavljajo sončni svetlobi.
English: You may not notice any symptoms in the early stages of macular oedema, and it can cause some of the same visual symptoms as an MS attack (optic neuritis).
Slovenian: V zgodnjih fazah razvoja makularnega edema morda ne opazite nobenega simptoma, lahko pa povzroča enake vidne simptome kot zagon multiple skleroze (optični nevritis).
English: Table 1 Dose titration regimen to reach maintenance dosage
Slovenian: Preglednica 1 Režim titracije odmerka za doseganje vzdrževalnega odmerjanja
English: In certain cases the patient may not receive treatment with siponimod due to specific CYP2C9 genotype status.
Slovenian: V določenih primerih bolniki ne smejo prejemati zdravljenja s siponimodom, če imajo poseben genotipski status CYP2C9.
English: If you have to restart Mayzent more than 4 days after you stopped taking it, your doctor will prescribe a new titration pack and you will have to restart treatment at day 1 again.
Slovenian: Če morate ponovno začeti z jemanjem zdravila Mayzent po tem, ko ga niste vzeli več kot 4 dni, vam bo zdravnik predpisal novo titracijsko pakiranje in ponovno boste morali začeti z odmerkom za 1. dan.
English: Proportion of patients with 4-point worsening in Symbol Digit Modality Test Risk reduction
Slovenian: delež bolnikov s poslabšanjem ocene na testu kodiranja (Symbol Digit Modality Test) za 4 točke zmanjšanje tveganja
English: You must use effective contraception during treatment and up to 10 days after stopping treatment (see “Pregnancy, breast-feeding and fertility”).
Slovenian: V času zdravljenja in še 10 dni po prekinitvi zdravljenja morate uporabljati učinkovito kontracepcijo (glejte pod naslovom “Nosečnost, dojenje in plodnost”).
English: These measures must be implemented before siponimod is prescribed to female patients and during treatment.
Slovenian: Ti ukrepi morajo biti izvedeni pred predpisovanjem siponimoda bolnicam in tudi med zdravljenjem.
English: An apparent systemic clearance (CL/F) of 3.11 l/h was estimated in MS patients.
Slovenian: Pri bolnikih z multiplo sklerozo je ocenjen navidezni sistemski očistek (CL/F) 3,11 l/h.
English: • Convulsions, fits
Slovenian: • konvulzije, krči
English: The receptor affected by siponimod (sphinosine-1-phosphate receptor) is known to be involved in vascular formation during embryogenesis.
Slovenian: Znano, da je receptor, na katerega vpliva siponimod, (receptor za sfingozin-1-fosfat) vpleten v nastajanje žilja v času embriogeneze.
English: Characteristics in specific groups or special populations
Slovenian: Značilnosti pri posebnih skupinah bolnikov
English: Do not use Mayzent during pregnancy, if you are trying to become pregnant or if you are a woman who could become pregnant and you are not using effective contraception.
Slovenian: Zdravila Mayzent ne uporabljajte v času nosečnosti oziroma če želite zanositi ali če ste ženska v rodni dobi in ne uporabljate učinkovite kontracepcije.
English: Mayzent can cause a swelling in the macula (the area of the eye that enables you to see shapes, colours and details) known as macular oedema.
Slovenian: Zdravilo Mayzent lahko povzroča otekanje v predelu makule (rumene pege, predela v očesu, ki vam omogoča, da vidite oblike, barve in podrobnosti) - tako otekanje imenujemo makularni edem.
English: Siponimod induces a dose-dependent reduction of the peripheral blood lymphocyte count within 6 hours of the first dose, due to the reversible sequestration of lymphocytes in lymphoid tissues.
Slovenian: Siponimod inducira od odmerka odvisno znižanje števila limfocitov v periferni krvi v 6 urah po prejemu prvega odmerka, ker povzroči reverzibilno sekvestracijo limfocitov v limfatičnem tkivu.
English: If you are taking a beta blocker, such as atenolol or propranolol, your doctor may ask you to temporarily stop your beta-blocker treatment until you have reached your full daily dose of Mayzent.
Slovenian: Če jemljete zaviralec adrenergičnih receptorjev beta, kot sta atenolol in propranolol, vam bo zdravnik morda naročil, da začasno prekinete zdravljenje z zaviralcem adrenergičnih receptorjev beta, dokler ne začnete prejemati polnega dnevnega odmerka zdravila Mayzent.
English: If Mayzent is used during pregnancy, there is a risk of harm to the unborn baby.
Slovenian: Pri uporabi zdravila Mayzent v času nosečnosti obstaja tveganje za škodljivo delovanje na nerojenega otroka.
English: The primary endpoint of the study was the time to 3-month confirmed disability progression (CDP) determined as at least a 1-point increase from baseline in EDSS (0.5 point increase for patients with baseline EDSS of 5.5 or more) sustained for 3 months.
Slovenian: Primarni cilj opazovanja v študiji je bil čas do 3-mesečnega potrjenega napredovanja invalidnosti, pri čemer je bilo napredovanje opredeljeno kot zvišanje ocene EDSS od izhodiščne za najmanj 1 točko (oziroma zvišanje za 0,5 točke pri bolnikih z izhodiščno oceno EDSS 5,5 ali več), ki je vztrajalo 3 mesece.
English: You should limit your exposure to the sun and UV rays by:
Slovenian: Za zmanjšano izpostavljenost sončni svetlobi in ultravijoličnim (UV) žarkom morate poskrbeti tako, da:
English: 9/l, if confirmed, should lead to dose reduction to 1 mg, because in clinical studies siponimod dose was reduced in patients with absolute lymphocyte counts <0.2 x 10 9/l.
Slovenian: 9/l, mu je treba znižati odmerek na 1 mg, ker so v kliničnih študijah bolnikom z absolutnim številom limfocitov <0,2 x 10
English: The efficacy of siponimod has been investigated in a phase III study evaluating once-daily doses of 2 mg in patients with SPMS.
Slovenian: Učinkovitost siponimoda so raziskovali v študiji faze III z vrednotenjem enkrat dnevnega odmerjanja 2 mg zdravila bolnikom s sekundarno progresivno multiplo sklerozo.
English: • Be using effective contraception during treatment and for at least 10 days after stopping treatment to avoid pregnancy due to the potential risk of harm to the unborn baby.
Slovenian: • da morajo uporabljati učinkovito kontracepcijo v času zdravljenja in še najmanj 10 dni po prekinitvi zdravljenja, da bi preprečile nosečnost, zaradi možnega tveganja za škodljive učinke zdravljenja na nerojenega otroka,
English: • Liver function tests should be performed before starting treatment and repeated if there are symptoms suggestive of hepatic dysfunction.
Slovenian: • Vrednosti testov delovanja jeter je treba določiti pred začetkom zdravljenja in preiskavo ponoviti, če pride do simptomov, ki kažejo na okvaro delovanja jeter.
English: Mayzent 2 mg film-coated tablets are available in packs containing 28 tablets.
Slovenian: Mayzent 2 mg filmsko obložene tablete so na voljo v pakiranjih, ki vsebujejo 28 tablet.
English: If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Slovenian: Če bolnik izpusti odmerek, naj naslednji predpisani odmerek vzame po razporedu in naj naslednjič ne vzame dvojnega odmerka.
English: What Mayzent is and what it is used for
Slovenian: Kaj je zdravilo Mayzent in za kaj ga uporabljamo
English: Assessments of CBC are also recommended periodically during treatment.
Slovenian: Hemogram je priporočeno pregledovati tudi periodično med zdravljenjem.
English: • if you have changes in your vision, for example if the centre of your vision becomes blurred or has shadows, a blind spot develops in the centre of your vision, or you have problems seeing colours or fine detail.
Slovenian: • če opažate spremembe vida, na primer če postane centralni del vidnega polja zamegljen ali se vam pred očmi pojavljajo sence, če v centralnem delu vidnega polja opažate slepo pego ali če imate težave z zaznavanjem barv ali podrobnosti.
English: Animal studies have demonstrated siponimod-induced embryotoxicity and foetotoxicity in rats and rabbits and teratogenicity in rats, including embryo-foetal deaths and skeletal or visceral malformations at exposure levels comparable to the human exposure at the daily dose of 2 mg (see section 5.3).
Slovenian: Študije na živalih so pokazale s siponimodom povzročeno embriotoksičnost in fetotoksičnost pri podganah in kuncih ter teratogenost pri podganah, kar vključuje smrt zarodka in ploda ter skeletne in visceralne malformacije pri ravni izpostavljenosti, ki je primerljiva z izpostavljenostjo pri ljudeh ob odmerjanju 2 mg na dan (glejte poglavje 5.3).
English: Class Ia and class III antiarrhythmic medicinal products have been associated with cases of torsades de pointes in patients with bradycardia.
Slovenian: Antiaritmike razredov Ia in III pri bolnikih z bradikardijo povezujejo s primeri torsades de pointes.
English: The side effects described in this leaflet may still occur during this period (see “Possible side effects” in section 4).
Slovenian: V tem času lahko še vedno pride do neželenih učinkov, ki so opisani v tem navodilu za uporabo (glejte poglavje 4 “Možni neželeni učinki”).
English: Pulmonary function
Slovenian: Pljučna funkcija
English: In addition, clinical experience with another sphingosine-1-phosphate receptor modulator indicated a 2-fold higher risk of major congenital malformations when administered during pregnancy compared with the rate observed in the general population.
Slovenian: Poleg tega klinične izkušnje z uporabo drugega modulatorja receptorja za sfingozin-1-fosfat (S1P) kažejo 2-kratno povečanje tveganja za pomembne prirojene nepravilnosti pri odmerjanju zdravila v času nosečnosti v primerjavi s pogostnostjo teh nepravilnosti v splošni populaciji.
English: • medicines that affect the immune system, such as chemotherapy, immunosuppressants or other medicines to treat MS.
Slovenian: • zdravila, ki vplivajo na imunski sistem, kot so kemoterapevtiki, imunosupresivna zdravila, ali druga zdravila za zdravljenje multiple skleroze.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: A few patients experienced mild to moderate symptoms including dizziness and non-cardiac chest pain, which resolved within 24 hours without intervention (see section 4.8).
Slovenian: Pri nekaj bolnikih je prišlo do blago do zmerno izraženih simptomov, med drugim do omotičnosti in nekardialne bolečine v prsnem košu, ki je izzvenela v 24 urah brez posebnega zdravljenja (glejte poglavje 4.8).
English: The single-dose pharmacokinetic parameters were not different between Japanese and Caucasian healthy subjects, indicating absence of ethnic sensitivity on the pharmacokinetics of siponimod.
Slovenian: Farmakokinetični parametri pri prejemu enkratnega odmerka se pri zdravih osebah niso razlikovali med Japonci in belci, kar kaže na to, da etnična pripadnost ne vpliva na farmakokinetiko siponimoda.
English: The median EDSS was 6.0 at baseline.
Slovenian: Mediana ocene EDSS ob izhodišču je bila 6,0.
English: What Mayzent is and what it is used for What you need to know before you take Mayzent How to take Mayzent
Slovenian: Kaj je zdravilo Mayzent in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Mayzent Kako jemati zdravilo Mayzent Možni neželeni učinki
English: Results from population pharmacokinetics suggest that dose adjustment is not necessary in elderly patients (age 65 years and above).
Slovenian: Rezultati populacijske farmakokinetične analize kažejo, da pri starejših bolnikih (starih 65 let in več) ni treba prilagajati odmerjanja.
English: How much Mayzent to take
Slovenian: Koliko zdravila Mayzent je treba jemati
English: Although there are no data to establish that patients with pre-existing liver disease are at increased risk of developing elevated liver function test values when taking siponimod, caution should be exercised in patients with a history of significant liver disease.
Slovenian: Čeprav ni podatkov, ki bi pri bolnikih z že prisotno boleznijo jeter potrjevali povečano tveganje za zvišanje vrednosti testov jetrne funkcije v času jemanja siponimoda, je pri uporabi pri bolnikih z anamnezo pomembne bolezni jeter potrebna previdnost.
English: • if you have ever had any of the following conditions (even if you are receiving treatment for them): severe heart disease, irregular or abnormal heartbeat (arrhythmia), stroke or other disease related to the blood vessels in the brain, a slow heart rate, fainting, disturbance of heart rhythm (indicated by abnormal ECG results).
Slovenian: • če ste imeli kadarkoli katero od naslednjih bolezni (tudi če prejemate zdravila zanjo): hudo bolezen srca, neredno ali nepravilno bitje srca (aritmijo), možgansko kap ali drugo bolezen krvnih žil v možganih, počasen srčni utrip, omedlevico, motnje srčnega ritma (ki so opazne na posnetku EKG).
English: No interaction studies have been performed with oral contraceptives containing other progestagens, however an effect of siponimod on the efficacy of oral contraceptives is not expected.
Slovenian: S peroralnimi kontracepcijskimi sredstvi, ki vsebujejo druge progestogene, niso izvedli interakcijskih študij, vendar ni pričakovati, da bi siponimod vplival na učinkovitost preoranih kontraceptivov.
English: This reduces nerve damage caused by SPMS and as a result Mayzent helps to slow down the effects of the disease activity (such as worsening disability, brain lesions and relapses).
Slovenian: To zmanjša okvaro živcev, ki jo povzroča sekundarno progresivna multipla skleroza in na ta način zdravilo Mayzent lahko pomaga upočasniti razvoj okvar, ki so posledica aktivnosti bolezni (kot so poslabšanje invalidnosti, spremembe v možganih in zagoni bolezni).
English: • Reproductive toxicity:
Slovenian: • Vpliv na sposobnost razmnoževanja:
English: Some patients presented with blurred vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine ophthalmological examination.
Slovenian: Pri nekaterih bolnikih je prišlo do zamegljenega vida ali zmanjšanja vidne ostrine, pri drugih pa ni bilo simptomov, diagnozo so jim postavili pri rutinskem oftalmološkem pregledu.
English: In repeat-dose toxicity studies in mice, rats and monkeys, siponimod markedly affected the lymphoid system (lymphopenia, lymphoid atrophy and reduced antibody response), which is consistent with its primary pharmacological activity at S1P1 receptors (see section 5.1).
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih pri miših, podganah in opicah je siponimod močno vplival na limfatični sistem (limfopenija, atrofija limfatičnega tkiva in zmanjšanje protitelesnega odziva), kar se ujema z njegovim primarnim farmakološkim delovanjem na receptorje S1P1 (glejte poglavje 5.1).
English: Blood pressure effects
Slovenian: Vpliv na krvni tlak
English: During the first 6 days of treatment, if you have forgotten to take your dose on one day, call your doctor before you take the next dose.
Slovenian: Če v prvih 6 dneh zdravljenja en dan pozabite vzeti odmerek, pokličite zdravnika, preden vzamete naslednji odmerek.
English: Unchanged siponimod was not detected in urine.
Slovenian: V urinu niso zasledili nespremenjenega siponimoda.
English: Physicians should be vigilant for clinical symptoms or magnetic resonance imaging (MRI) findings that may be suggestive of PML.
Slovenian: Zdravniki morajo biti pozorni na klinične simptome in izvide magnetnoresonančnega (MR) slikanja, ki bi lahko kazali na PML.
English: Manufacturer Novartis Pharma GmbH Roonstrasse 25
Slovenian: Proizvajalec Novartis Pharma GmbH Roonstrasse 25
English: • For patients with certain heart problems, an ECG before initiating treatment with siponimod will be needed.
Slovenian: • Bolnikom, ki imajo določene težave s srcem, je treba pred začetkom zdravljenja s siponimodom posneti EKG.