FrancophonIA/ELRC3.0 huggingface dataset:
English: Minor reductions in forced expiratory volume in 1 second (FEV1) and in the diffusing capacity of the lung for carbon monoxide (DLCO) values were observed with siponimod treatment.
Slovenian: Pri zdravljenju s siponimodom so opažali rahlo zmanjšanje vrednosti forsiranega ekspiracijskega volumna v prvi sekundi (FEV1) in difuzijske kapacitete pljuč za ogljikov monoksid (DLCO).
English: Atrioventricular conduction
Slovenian: Atrioventrikularno prevajanje
English: Use of siponimod in these patients results in substantially elevated siponimod plasma levels.
Slovenian: Pri uporabi siponimoda pri teh bolnikih je koncentracija siponimoda v plazmi precej zvišana.
English: An ophthalmological evaluation is therefore recommended 3-4 months after treatment initiation.
Slovenian: Zato se 3-4 mesece po začetku zdravljenja priporoča opraviti oftalmološki pregled.
English: Concomitant treatment with anti-neoplastic, immune-modulating or immunosuppressive therapies Anti-neoplastic, immune-modulating or immunosuppressive therapies (including corticosteroids) should be co-administered with caution due to the risk of additive immune system effects during such therapy (see section 4.5).
Slovenian: Sočasno zdravljenje z antineoplastičnimi, imunomodulatornimi ali imunosupresivnimi zdravili Pri sočasni uporabi antineoplastičnih, imunomodulatornih oziroma imunosupresivnih zdravil (vključno s kortikosteroidi) je potrebna previdnost zaradi tveganja za aditivne učinke na imunski sistem pri takem zdravljenju (glejte poglavje 4.5).
English: For 2 mg siponimod given once daily over 10 days, a mean Cmax of 30.4 ng/ml and mean AUCtau of 558 h*ng/ml were observed on day 10.
Slovenian: Pri odmerjanju 2 mg siponimoda enkrat na dan 10 dni so na 10. dan izmerili povprečno Cmax 30,4 ng/ml in povprečno AUCtau 558 h*ng/ml.
English: CYP2C9 is polymorphic and the genotype influences the fractional contributions of the two oxidative metabolism pathways to overall elimination.
Slovenian: CYP2C9 je polimorfen encim in njegov genotip vpliva na to, v kolikšni meri je v celokupno izločanje vpletena katera od dveh poti oksidativnega metabolizma.
English: The upper bound of the one-sided 95% CI for the ΔΔQTcF at all time points remained below 10 ms. Categorical analysis revealed no treatment-emergent QTc values above 480 ms, no QTc increases from baseline of more than 60 ms and no corrected or uncorrected QT/QTc value exceeded 500 ms.
Slovenian: Pri kategorični analizi niso odkrili nobene vrednosti z zdravljenjem povzročenega trajanja intervala QTc nad 480 ms, nobenega podaljšanja intervala QTc od izhodišča za več kot 60 ms in nobene korigirane ali nekorigirane vrednosti razmerja QT/QTc, ki bi presegala 500 ms.
English: Blood and lymphatic system disorders Common
Slovenian: Bolezni krvi in limfatičnega sistema pogosti limfopenija
English: What Mayzent looks like and contents of the pack Mayzent 0.25 mg film-coated tablets are pale red, round film-coated tablets with the company logo on one side and “T” on the other side.
Slovenian: Izgled zdravila Mayzent in vsebina pakiranja Mayzent 0,25 mg filmsko obložene tablete so bledo rdeče okrogle filmsko obložene tablete z logotipom družbe na eni strani in oznako “T” na drugi.
English: After stopping siponimod treatment residual lowering effects on peripheral lymphocyte count may persist for up to 3-4 weeks after the last dose.
Slovenian: Po prekinitvi zdravljenja s siponimodom lahko rezidualni učinek na znižanje števila perifernih limfocitov vztraja še 3 do 4 tedne po prejemu zadnjega odmerka.
English: However, because of an expected reduction in siponimod exposure, the appropriateness and possible benefit of the treatment should be considered when siponimod is combined: - with strong CYP3A4/moderate CYP2C9 inducers (e.g. carbamazepine) in all patients regardless of genotype - with moderate CYP3A4 inducers (e.g. modafinil) in patients with a CYP2C9*1*3 or *2*3
Slovenian: Zaradi pričakovanega zmanjšanja izpostavljenosti siponimodu pa je v primeru zdravljenja v kombinaciji z naslednjimi zdravili treba pretehtati primernost in možne koristi zdravljenja: - z močnimi induktorji CYP3A4 oziroma zmernimi induktorji CYP2C9 (kot je karbamazepin) pri vseh bolnikih ne glede na genotip, - z zmernimi induktorji CYP3A4 (kot je modafinil) pri bolnikih z genotipom CYP2C9*1*3 ali
English: Laboratory tests involving the use of circulating mononuclear cells require larger blood volumes due to reduction in the number of circulating lymphocytes.
Slovenian: Zaradi znižanega števila cirkulirajočih limfocitov je za laboratorijske preiskave, ki vključujejo uporabo cirkulirajočih mononuklearnih celic, potrebna večja količina krvi.
English: However, residual pharmacodynamic effects, such as lowering effects on peripheral lymphocyte count, may persist for up to 3-4 weeks after the last dose.
Slovenian: Rezidualni farmakodinamični učinki zdravila, kot je učinek zniževanja števila perifernih limfocitov, pa lahko vztrajajo še 3 do 4 tedne po prejemu zadnjega odmerka.
English: Since initiation of treatment results in decreased heart rate, siponimod should not be used concomitantly with these medicinal products during treatment initiation.
Slovenian: Ker uvajanje zdravljenja s siponimodom povzroča znižanje srčne frekvence, se tega zdravila ne sme uporabljati sočasno z navedenimi zdravili v času titriranja odmerka.
English: The pregnancy-specific patient reminder card shall contain the following key messages:
Slovenian: Opozorilna kartica za bolnice glede nosečnosti mora vsebovati naslednja ključna sporočila:
English: Figure 1 Patients with 3- and 6-month CDP based on EDSS-Kaplan-Meier curves (full analysis set, study A2304)
Slovenian: Slika 1 Bolniki s 3-mesečnim in 6-mesečnim potrjenim napredovanjem invalidnosti na osnovi ocene EDSS - Kaplan-Meierjeve krivulje (podatki bolnikov za celotno analizo, full analysis set, študija A2304)
English: • Exercise caution when administering concomitant treatment with anti-neoplastic, immune-modulating or immunosuppressive therapies (including corticosteroids) due to the risk of additive immune system effects.
Slovenian: • Previdnost je potrebna pri sočasnem dajanju antineoplastičnih, imunomodulatornih oziroma imunosupresivnih zdravil (vključno s kortikosteroidi) zaradi tveganja za aditivno delovanje na imunski sistem.
English: • Be familiar with the Mayzent Prescribing Information.
Slovenian: • Natančno preglejte informacije o zdravilu Mayzent.
English: • carbamazepine and certain other medicines can lower the levels of Mayzent in your blood and can therefore stop it from working properly.
Slovenian: • karbamazepin in nekatera druga zdravila lahko znižajo koncentracijo zdravila Mayzent v krvi in s tem preprečijo, da bi zdravilo ustrezno delovalo.
English: Pregnant women should be advised of potential serious risks to the foetus, and ultrasonography examinations should be performed.
Slovenian: Nosečim ženskam je treba strokovno svetovati glede možnih resnih tveganj za plod in izvajati ultrazvočne preiskave.
English: If you need to have a vaccination, talk to your doctor first.
Slovenian: • cepiva: če morate biti cepljeni, se najprej posvetujte z zdravnikom.
English: Siponimod is eliminated from the systemic circulation mainly due to metabolism and subsequent biliary/faecal excretion.
Slovenian: Siponimod se iz sistemskega krvnega obtoka izloča večinoma s presnavljanjem in nato izločanjem z žolčem oziroma blatom.
English: • Patients should report any unexpected neurological or psychiatric symptoms/signs (such as sudden onset of severe headache, confusion, seizures and vision changes) or accelerated neurological deterioration to their doctors.
Slovenian: • Bolniki morajo sporočiti svojim zdravnikom, če opažajo nepričakovane nevrološke ali psihiatrične simptome ali znake (kot so nenaden pojav hudega glavobola, zmedenost, napad s krči in spremembe vida) ali pospešeno slabšanje nevrološkega stanja.
English: • Initiate treatment with a titration pack that lasts for 5 days.
Slovenian: • Zdravljenje začnite s titracijskim pakiranjem, ki zadostuje za 5 dni zdravljenja.
English: Your doctor may want you to have eye examinations before you start treatment and regularly while you are on treatment.
Slovenian: Zdravnik vam bo svetoval, da opravite pregled oči pred začetkom zdravljenja in nato preglede opravljate redno tudi v času zdravljenja.
English: • An ophthalmological evaluation 3-4 months after treatment initiation with siponimod is recommended.
Slovenian: • Priporoča se, da bolnik opravi oftalmološki pregled 3-4 mesece po začetku zdravljenja s siponimodom.
English: Siponimod is contraindicated in women of childbearing potential not using effective contraception (see section 4.3).
Slovenian: Uporaba siponimoda je kontraindicirana pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (glejte poglavje 4.3).
English: Patients with symptoms and signs consistent with CM should undergo prompt diagnostic evaluation.
Slovenian: Pri bolnikih s simptomi in znaki, ki kažejo na kriptokokni meningitis, je treba takoj izvesti diagnostično obravnavo.
English: TITRATION
Slovenian: Titracija
English: Initiation of siponimod treatment has been associated with transient atrioventricular conduction delays that follow a similar temporal pattern to the observed decrease in heart rate during dose titration.
Slovenian: Uvajanje zdravljenja s siponimodom povezujejo s prehodno upočasnitvijo atrioventrikularnega prevajanja s podobnim časovnim potekom kot pri znižanju srčne frekvence v času titracije odmerka.
English: Siponimod has not been studied in combination with antineoplastic, immune-modulating or immunosuppressive therapies.
Slovenian: Uporabe siponimoda v kombinaciji z antineoplastičnimi, imunomodulatornimi ali imunosupresivnimi zdravili niso proučevali.
English: • Be informed before treatment initiation and regularly thereafter by their physician about siponimod serious risks to the foetus and about the contraindication in pregnant women and in women of childbearing potential not using effective contraception, facilitated by the Pregnancy Reminder Card.
Slovenian: • da jih mora njihov zdravnik pred začetkom zdravljenja in redno tudi kasneje obveščati o resnih tveganjih siponimoda za plod in o tem, da je uporaba siponimoda kontraindicirana v času nosečnosti in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, pri čemer naj si zdravnik pomaga z opozorilno kartico glede nosečnosti,
English: Treatment with Mayzent will be overseen by a doctor who is experienced in the treatment of MS.
Slovenian: Zdravljenje z zdravilom Mayzent bo nadzoroval zdravnik z izkušnjami pri zdravljenju multiple skleroze.
English: Resumption of therapy will be dependent on whether or not another cause of liver injury is determined and on the benefits to the patient of resuming therapy versus the risks of recurrence of liver dysfunction.
Slovenian: Zdravljenje se bolniku sme ponovno uvesti v primeru, da pri njem odkrijejo drug vzrok okvare jeter in korist pri ponovni uvedbi zdravljenja presega tveganje za ponovitev okvare jeter.
English: In such patients, treatment with siponimod should be considered only if the anticipated benefits outweigh the potential risks, and advice from a cardiologist should be sought prior to initiation of treatment in order to determine the most appropriate monitoring strategy.
Slovenian: Pri takih bolnikih se o zdravljenju s siponimodom sme razmisliti samo v primeru, da pričakovane koristi presegajo možna tveganja, pred začetkom zdravljenja pa se je treba posvetovati s kardiologom glede najbolj primerne strategije spremljanja bolnika.
English: • Patients should read the package leaflet thoroughly before starting treatment and should keep the package leaflet in case they need to refer to it again during treatment.
Slovenian: • Bolniki morajo pred začetkom zdravljenja natančno prebrati navodilo za uporabo in ga shraniti, če ga bodo v času zdravljenja morda želeli ponovno prebrati.
English: Additional secondary endpoints included time to 6-month CDP, percent brain volume change and measures of inflammatory disease activity (annualised relapse rate, MRI lesions).
Slovenian: Med drugimi sekundarnimi cilji opazovanja so bili čas do 6-mesečnega potrjenega napredovanja invalidnosti, odstotna sprememba prostornine možganov in kazalci vnetne aktivnosti bolezni (pogostnost zagonov, preračunana na eno leto, lezije na MR posnetkih).
English: No cases of progressive multifocal leukoencephalopathy (PML) have been reported for siponimod in the development programme; however, they have been reported for another S1P receptor modulator.
Slovenian: V okviru razvojnega programa niso pri uporabi siponimoda poročali o nobenem primeru progresivne multifokalne levkoencefalopatije (PML), so pa o njih poročali pri uporabi drugega modulatorja receptorja za S1P.
English: • If a woman becomes pregnant while on treatment with siponimod, treatment must be discontinued.
Slovenian: • Če ženska v času zdravljenja s siponimodom zanosi, mora zdravljenje prekiniti.
English: If you do become pregnant while taking Mayzent, tell your doctor straight away.
Slovenian: Če se kljub vsemu zgodi, da zanosite v času jemanja zdravila Mayzent, takoj obvestite zdravnika.
English: Patients without a physician-confirmed history of varicella or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before starting siponimod (see below section “Vaccination”).
Slovenian: Bolnike, pri katerih anamneze noric ni potrdil zdravnik oziroma nimajo dokumentacije o opravljenem celotnem cepljenju proti virusu noric, je treba testirati na prisotnost protiteles proti virusu varicella zoster pred začetkom zdravljenja s siponimodom (glejte spodaj poglavje “Cepljenje”).
English: Due to risk for the foetus, siponimod is contraindicated during pregnancy and in women of childbearing potential not using effective contraception.
Slovenian: Zaradi tveganja za plod je uporaba siponimoda kontraindicirana v času nosečnosti in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: The Patient/Caregiver Guide shall contain the following key messages:
Slovenian: Vodnik za bolnike/skrbnike mora vsebovati naslednja ključna sporočila:
English: If you stop taking Mayzent Do not stop taking Mayzent or change your dose without talking to your doctor first.
Slovenian: Ne prenehajte jemati zdravila Mayzent in ne spreminjajte odmerka, ne da bi se prej posvetovali s svojim zdravnikom.
English: Steady state was reached after approximately 6 days of multiple once-daily administration of siponimod.
Slovenian: Do stanja dinamičnega ravnovesja je prišlo po približno 6 dneh večkratnega odmerjanja siponimoda enkrat na dan.
English: - Patients homozygous for CYP2C9*3 (CYP2C9*3*3) genotype (poor metaboliser).
Slovenian: - Bolniki, ki imajo homozigotni genotip CYP2C9*3 (CYP2C9*3*3) (slabi presnavljalci).
English: Because of a significant increase in exposure to siponimod, concomitant use of siponimod and medicinal products that cause moderate CYP2C9 and moderate or strong CYP3A4 inhibition is not recommended.
Slovenian: Zaradi precejšnjega povečanja izpostavljenosti siponimodu se ne priporoča sočasna uporaba siponimoda z zdravili, ki zmerno zavirajo CYP2C9 in zmerno ali močno zavirajo CYP3A4.
English: The co-administration of fluconazole (moderate CYP2C9/strong CYP3A4 inhibitor) 200 mg daily at steady state and a single dose of siponimod 4 mg in healthy volunteers with a CYP2C9*1*1 genotype led to a 2-fold increase in the area under the curve (AUC) of siponimod.
Slovenian: Sočasno odmerjanje flukonazola (zmernega zaviralca CYP2C9/močnega zaviralca CYP3A4) v odmerku 200 mg na dan v stanju dinamičnega ravnovesja in enkratnega odmerka siponimoda 4 mg je pri zdravih prostovoljcih z genotipom CYP2C9*1*1 povzročilo dvakratno povečanje površine pod krivuljo (AUC) siponimoda.
English: Discontinuation of treatment 1 week prior to planned vaccination until 4 weeks after is recommended.
Slovenian: Priporočeno je, da bolnik zdravljenje prekine en teden pred načrtovanim cepljenjem in z zdravljenjem ne začne še 4 tedne po cepljenju.
English: Treatment needs to be reinitiated with a new titration pack.
Slovenian: V teh primerih morajo zdravljenje začeti od začetka z novim titracijskim pakiranjem.
English: According to evaluation of the drug interaction potential using physiologically based pharmacokinetic (PBPK) modelling, a maximum of a 2-fold increase in the AUC of siponimod is predicted across genotypes with any type of CYP3A4 and CYP2C9 inhibitors except for patients with a CYP2C9*2*2 genotype.
Slovenian: Po podatkih vrednotenja potenciala za interakcije s pomočjo farmakokinetičnega modeliranja na osnovi fizioloških procesov je mogoče pričakovati največ dvakratno povečanje AUC siponimoda pri vseh genotipih pri odmerjanju katere koli vrste zaviralca CYP3A4 ali CYP2C9 razen pri bolnikih z genotipom CYP2C9*2*2.
English: Re-initiation of maintenance therapy after treatment interruption If maintenance treatment is interrupted for 4 or more consecutive daily doses, siponimod needs to be re-initiated with a new titration pack.
Slovenian: Ponovna uvedba zdravljenja po prekinitvi vzdrževalnega zdravljenja Če bolnik prekine vzdrževalno zdravljenje tako, da izpusti 4 ali več zaporednih dnevnih odmerkov, mora zdravljenje s siponimodom ponovno začeti od začetka z novim titracijskim pakiranjem.
English: Siponimod increased the placebo-corrected baseline-adjusted mean QTcF (ΔΔQTcF) by more than 5 ms, with a maximum mean effect of 7.8 ms (2 mg) and 7.2 ms (10 mg), respectively, at 3 h post-dose.
Slovenian: Rezultati ne kažejo na aritmogeni potencial siponimoda zaradi podaljševanja intervala QT. Siponimod je podaljšal vrednost korigiranega (za vrednost pri uporabi placeba) in na izhodiščno vrednost prilagojenega povprečja trajanja QTcF (ΔΔQTcF) za več kot 5 ms z največjim povprečnim učinkom 7,8 ms (pri odmerku 2 mg) oziroma 7,2 ms (pri odmerku 10 mg) pri meritvi 3 ure po odmerjanju.
English: o Appropriate management should be initiated and observation continued until the symptoms/findings have resolved if the following events are observed: a.
Slovenian: o Če pride do naslednjih motenj, je treba uvesti ustrezno zdravljenje in nadaljevati z opazovanjem bolnika, dokler se simptomi ne umirijo oziroma izvidi ne normalizirajo: a.
English: Siponimod should be used with caution in the elderly (see section 4.2).
Slovenian: Pri starostnikih je pri uporabi siponimoda potrebna previdnost (glejte poglavje 4.2).
English: • Should a pregnancy occur during treatment or within 10 days following discontinuation of treatment with siponimod, it should be immediately reported to the doctor or to Novartis by calling [insert local number] or visiting [insert URL], irrespective of adverse outcomes observed.
Slovenian: • Če ženska v času zdravljenja ali v 10 dneh po prekinitvi zdravljenja s siponimodom zanosi, je treba to takoj poročati zdravniku ali družbi Novartis na telefonsko številko [vpišite lokalno številko] ali preko spletne strani [vpišite naslov], tudi če je izid nosečnosti neugoden.
English: • Should a patient develop any unexpected neurological or psychiatric symptoms/signs or accelerated neurological deterioration, a complete physical and neurological examination should promptly be scheduled and MRI should be considered.
Slovenian: • Če pri bolniku pride do nepričakovanih nevroloških ali psihiatričnih simptomov oziroma znakov ali do pospešenega slabšanja nevrološkega stanja, je treba takoj izvesti celoten klinični in nevrološki pregled ter razmisliti o magnetnoresonančnem (MR) slikanju.
English: Low lymphocyte counts are maintained with daily dosing.
Slovenian: Ob vsakodnevnem odmerjanju ostaja število limfocitov znižano.
English: Table 3 Clinical and MRI results of study A2304
Slovenian: Preglednica 3 Klinični parametri in izvidi MR slikanja v študiji A2304
English: • Cases of progressive multifocal leukoencephalopathy (PML) have been reported with another sphingosine 1-phosphate (S1P) receptor modulator.
Slovenian: • O primerih progresivne multifokalne levkoencefalopatije (PML) so poročali pri uporabi drugega modulatorja receptorja za sfingozin-1-fosfat (S1P).
English: If CM is diagnosed, appropriate treatment should be initiated.
Slovenian: V primeru postavljene diagnoze kriptokoknega meningitisa je treba uvesti ustrezno zdravljenje.
English: Proportion of patients with 6-month confirmed disability progression
Slovenian: delež bolnikov s 6-mesečnim potrjenim napredovanjem invalidnosti zmanjšanje tveganja
English: • if you have symptoms such as unexplained nausea, vomiting, abdominal pain, tiredness, yellowing of the skin or whites of the eyes or abnormally dark urine.
Slovenian: • če imate simptome, kot so nepojasnjen občutek slabosti, bruhanje, bolečine v trebuhu, utrujenost, rumeno obarvanje kože ali beločnic ali nenormalno temno obarvan urin: lahko gre za simptome težav z jetri.
English: Siponimod is extensively metabolised, mainly by cytochrome P450 2C9 (CYP2C9) (79.3%), and to a lesser extent by cytochrome P450 3A4 (CYP3A4) (18.5%).
Slovenian: Siponimod se obsežno presnavlja, pretežno s citokromom P450 2C9 (CYP2C9) (79,3 %) in v manjši meri s citokromom P450 3A4 (CYP3A4) (18,5 %).
English: How Mayzent works
Slovenian: Kako deluje zdravilo Mayzent
English: Your doctor will advise you on this (see “Other medicines and Mayzent”).
Slovenian: • če se nameravate cepiti proti katerikoli bolezni: zdravnik vam bo glede tega ustrezno svetoval (glejte pod naslovom “Druga zdravila in zdravilo Mayzent”).
English: The ARR (confirmed relapses) was reduced by 46% (ARR ratio 0.54; 95% CI: 0.39, 0.77) compared to placebo.
Slovenian: Pogostnost (potrjenih) zagonov, preračunana na eno leto (annualised relapse rate ARR), je bila manjša za 46 % (razmerje ARR 0,54; 95-odstotni IZ: 0,39, 0,77) v primerjavi z uporabo placeba.
English: Mayzent 2 mg film-coated tablets are pale yellow, round film-coated tablets with the company logo on one side and “II” on the other side.
Slovenian: Mayzent 2 mg filmsko obložene tablete so bledo rumene okrogle filmsko obložene tablete z logotipom družbe na eni strani in oznako “II” na drugi.
English: • Patients with a history of second-degree Mobitz type II atrioventricular (AV) block, third-degree AV block, sino-atrial heart block or sick sinus syndrome, if they do not wear a pacemaker.
Slovenian: • bolnikih z anamnezo atrioventrikularnega bloka druge stopnje tipa Mobitz II ali atrioventrikularnega bloka tretje stopnje, sinuatrialnega bloka ali bolezni sinusnega vozla, če nimajo srčnega spodbujevalnika.
English: Patients with hypertension uncontrolled by medication were excluded from participation in clinical studies and special care is indicated if patients with uncontrolled hypertension are treated with siponimod.
Slovenian: V klinične študije niso vključevali bolnikov, ki so imeli neurejeno hipertenzijo kljub jemanju zdravil, zato je potrebna posebna pozornost pri bolnikih, ki imajo neurejeno hipertenzijo in jemljejo siponimod.
English: (95% CI: -1484, -843 mm 3) and 0.141% (95% CI: 0.020, 0.261%), respectively.
Slovenian: (95-odstotni IZ: -1484, -843 mm 3), razlika v odstotku spremembe prostornine možganov v primerjavi s placebom (povprečja vrednosti po 12 oziroma po 24 mesecih) pa je bila 0,141 % (95-odstotni IZ: 0,020, 0,261 %).
English: Therefore, before initiation of treatment in women of childbearing potential a negative pregnancy test result must be available and counselling should be provided regarding serious risk to the foetus.
Slovenian: Zato morajo ženske v rodni dobi pred začetkom zdravljenja s siponimodom opraviti nosečnostni test, ki mora biti negativen, ženske pa je treba opozoriti na resno tveganja za plod.
English: Siponimod has not been studied in patients with arrhythmias requiring treatment with class Ia (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic medicinal products.
Slovenian: Uporabe siponimoda niso proučevali pri bolnikih z aritmijami, pri katerih bi bilo potrebno zdravljenje z antiaritmiki razreda Ia (na primer s kinidinom ali prokainamidom) ali razreda III (na primer z amiodaronom ali sotalolom).