FrancophonIA/ELRC3.0 huggingface dataset:
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
Croatian: Međutim, zbog očekivanog smanjenja izloženosti siponimodu, potrebno je razmotriti prikladnost i moguću korist liječenja kad se siponimod kombinira: - sa snažnim CYP3A4/umjerenim CYP2C9 induktorima (npr. karbamazepin) u svih bolesnika bez obzira na genotip - s umjerenim CYP3A4 induktorima (npr. modafinil) u bolesnika s genotipom CYP2C9*1*3 ili
English: Change in cognitive processing speed on Symbol Digit Modality Test score was an exploratory endpoint.
Croatian: Symbol Digit Modality Test) bila je eksploratorna mjera ishoda.
English: What Mayzent is
Croatian: Što je Mayzent
English: Initiation of siponimod treatment results in a transient decrease in heart rate and may also be associated with atrioventricular conduction delays (see section 4.4).
Croatian: Započinjanje liječenja siponimodom rezultira prolaznim smanjenjem srčane frekvencije, a može biti povezano i s odgodama u antrioventrikularnom provođenju (vidjeti dio 4.4).
English: The unbound siponimod pharmacokinetics AUC is 15% and 50% higher in subjects with moderate and severe hepatic impairment, respectively, in comparison with healthy subjects for the 0.25 mg single dose studied.
Croatian: AUC za farmakokinetiku nevezanog siponimoda viši je za 15% u bolesnika s umjerenim oštećenjem funkcije jetre te za 50% u bolesnika s teškim oštećenjem funkcije jetre, u usporedbi sa zdravim ispitanicima za ispitanu jednokratnu dozu od 0,25 mg.
English: Figure 2 Patients with 3- and 6-month CDP based on EDSS-Kaplan-Meier curvesSubgroup with active SPMS (full analysis set, study A2304)
Croatian: Slika 2 Bolesnici s 3-mjesečnim i 6-mjesečnim CDP-om na temelju EDSS a - Kaplan Meierove krivulje - podskupina s aktivnim SPMS-om (analiza potpunog skupa podataka, ispitivanje A2304)
English: Effective contraception should be maintained for at least 10 days following discontinuation of treatment with siponimod.
Croatian: Učinkovitu kontracepciju treba koristiti još barem 10 dana nakon prestanka liječenja siponimodom.
English: (95% CI: -1484, -843 mm 3) and 0.141% (95% CI: 0.020, 0.261%), respectively.
Croatian: (95% CI: -1484; -843 mm 3) odnosno 0,141%
English: This concomitant drug regimen can consist of a moderate CYP2C9/CYP3A4 dual inhibitor (e.g. fluconazole) or a moderate CYP2C9 inhibitor in combination with a separate moderate or strong CYP3A4 inhibitor.
Croatian: Ovaj režim istodobne primjene lijekova može se odnositi na umjereni dvostruki CYP2C9/CYP3A4 inhibitor (npr. flukonazol) ili umjereni CYP2C9 inhibitor u kombinaciji s drugim umjerenim ili jakim CYP3A4 inhibitorom.
English: The highest daily post-dose decrease in absolute hourly mean heart rate is observed on day 1, with the pulse declining on average 5 to 6 beats per minute (bpm).
Croatian: Najveće dnevno smanjenje u apsolutnoj satnoj srednjoj srčanoj frekvenciji, nakon uzimanja doze, opaža se 1. dana, pri čemu se puls smanjivao u prosjeku 5 do 6 otkucaja u minuti.
English: Hypertension was more frequently reported in patients on siponimod (12.6%) than in those given placebo (9.0%) in the phase III clinical study in patients with SPMS.
Croatian: Hipertenzija je bila češće prijavljena u bolesnika na siponimodu (12,6%) nego u onih koji su dobivali placebo (9,0%) u kliničkom ispitivanju faze III u bolesnika s SPMS-om.
English: The effects of end-stage renal disease or haemodialysis on the pharmacokinetics of siponimod have not been studied.
Croatian: Učinci bolesti bubrega u završnom stadiju ili hemodijalize na farmakokinetiku siponimoda nisu bili ispitivani.
English: In CYP2C9*2*2 patients, a 2.7-fold increase in the AUC of siponimod is expected in the presence of moderate CYP2C9/CYP3A4 inhibitors.
Croatian: U CYP2C9*2*2 bolesnika očekuje se povećanje AUC-a siponimoda za 2,7 puta u prisutnosti umjerenih CYP2C9/CYP3A4 inhibitora.
English: • The signs and symptoms of infection during, and up to one month after treatment with siponimod need to be reported immediately to the prescriber.
Croatian: • Znakovi i simptomi infekcije tijekom liječenja te do mjesec dana nakon liječenja siponimodom moraju se odmah prijaviti liječniku koji je propisao lijek.
English: Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes checked and siponimod should be discontinued if significant liver injury is confirmed.
Croatian: Bolesnicima u kojih se razviju simptomi koji ukazuju na jetrenu disfunkciju potrebno je provjeriti jetrene enzime a siponimod obustaviti ako se potvrdi značajno oštećenje jetre.
English: WALLET CONTAINING BLISTER (titration pack of 12 film-coated tablets of 0.25 mg)
Croatian: OVITAK U OBLIKU NOVČANIKA KOJI SADRŽI BLISTER (pakiranje za titraciju s 12 filmom obloženih tableta od 0,25 mg)
English: Table 4 CYP2C9 genotype effect on siponimod CL/F and systemic exposure
Croatian: Tablica 4 Genotip CYP2C9 utječe na CL/F siponimoda i sistemsku izloženost
English: Pregnant women should be advised of potential serious risks to the foetus, and ultrasonography examinations should be performed.
Croatian: Trudnicu je potrebno obavijestiti o mogućim ozbiljnim rizicima za fetus te obaviti preglede ultrazvukom.
English: When stopping siponimod therapy for vaccination, the possible return of disease activity should be considered (see below section “Stopping siponimod therapy”).
Croatian: Kad se prekida liječenje siponimodom zbog cijepljenja, potrebno je uzeti u obzir mogući povratak aktivnosti bolesti (vidjeti u nastavku dio „Prekid terapije siponimodom“.
English: Treatment with siponimod can then be initiated and treatment with beta blocker can be re-initiated after siponimod has been up-titrated to the target maintenance dose (see section 4.5).
Croatian: Liječenje siponimodom zatim se može započeti, a liječenje beta blokatorom može se ponovno započeti nakon što se doza siponimoda titracijom poveća na ciljanu dozu održavanja (vidjeti dio 4.5).
English: Macular oedema with or without visual symptoms was more frequently reported on siponimod (1.8%) than on placebo (0.2%) in the phase III clinical study (see section 4.8).
Croatian: Makularni edem sa ili bez vizualnih simptoma bio je češće prijavljen uz siponimod (1,8%) nego uz placebo (0,2%) u kliničkom ispitivanju faze III (vidjeti dio 4.8).
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.
Croatian: Prema evaluaciji potencijala za interakciju lijekova koristeći fiziološki bazirano farmakokinetičko (PBPK) modeliranje, predviđa se najviše dvostruko povećanje AUC-a siponimoda za genotipove s bilo kojim tipom CYP3A4 i CYP2C9 inhibitora osim za bolesnike s genotipom CYP2C9*2*2.
English: Time to 3-month CDP versus placebo
Croatian: Vrijeme do 3-mjesečnog CDP-a u odnosu na placebo
English: The Patient/Caregiver Guide shall contain the following key messages:
Croatian: Vodič za bolesnika/skrbnika će sadržavati sljedeće ključne poruke:
English: Mayzent contains lactose and soya lecithin
Croatian: Mayzent sadrži laktozu i sojin lecitin
English: Study A2304 was a randomised, double-blind, placebo-controlled, event and follow-up duration driven, phase III study in patients with SPMS who had documented evidence of progression in the prior 2 years in the absence or independent of relapses, no evidence of relapse in the 3 months prior to study enrolment and with a median Expanded Disability Status Scale (EDSS) score of 3.0 to 6.5 at study entry.
Croatian: Ispitivanje A2304 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze III, s dizajnom vođenim događajima i trajanjem praćenja, u bolesnika s SPMS-om koji su imali dokumentirane dokaze progresije u prethodne 2 godine bez relapsa ili neovisno o relapsima, bez dokaza relapsa u 3 mjeseca prije uključivanja u ispitivanje te s medijanom rezultata na Proširenoj ljestvici za ocjenu stupnja onesposobljenosti (engl.
English: In patients with a CYP2C9*3*3 genotype, siponimod should not be used (see sections 4.3, 4.4 and
Croatian: U bolesnika s genotipom CYP2C9*3*3 ne smije se primjenjivati siponimod (vidjeti dijelove 4.3, 4.4 i
English: • Before initiating treatment, a recent complete blood count (CBC) (i.e. within 6 months or after discontinuation of prior therapy) should be available.
Croatian: • Prije započinjanja liječenja treba biti dostupan noviji nalaz kompletne krvne slike (KKS) (tj. napravljene unutar 6 mjeseci ili nakon prekida prethodne terapije).
English: Table 2 Tabulated list of adverse reactions
Croatian: Tablica 2 Tablični popis nuspojava
English: Caution should be exercised when siponimod is initiated in patients receiving beta blockers due to the additive effects on lowering heart rate (see section 4.4).
Croatian: Potreban je oprez kad se započinje terapija siponimodom u bolesnika koji primaju beta blokatore zbog aditivnih učinaka na smanjenje srčane frekvencije (vidjeti dio 4.4).
English: In the phase III study in patients with SPMS, liver function test increases were more frequently observed in patients on siponimod (11.3%) than in those on placebo (3.1%), mainly due to liver transaminase (ALT/AST) and GGT elevations.
Croatian: U ispitivanju faze III u bolesnika s SPMS-om, povišenja rezultata testa jetrene funkcije bila su češće opažena u bolesnika na siponimodu (11,3%) nego u onih na placebu (3,1%), uglavnom zbog povišenja jetrenih transaminaza (ALT/AST) i GGT-a.
English: The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during siponimod treatment and for up to 4 weeks after treatment (see section 4.4).
Croatian: Primjena živih atenuiranih cjepiva može uključivati rizik od infekcije i zato se treba izbjegavati tijekom liječenja siponimodom te do 4 tjedna nakon liječenja (vidjeti dio 4.4).
English: It may also cause your heartbeat to become irregular at the beginning of treatment.
Croatian: Lijek također može uzrokovati nepravilne otkucaje srca na početku liječenja.
English: Before initiating treatment, a recent complete blood count (CBC) (i.e. within last 6 months or after discontinuation of prior therapy) should be available.
Croatian: Prije početka liječenja treba biti dostupna nedavno napravljena kompletna krvna slika (KKS) (tj. unutar zadnjih 6 mjeseci ili nakon prekida primjene prethodne terapije).
English: • Perform liver function tests prior to initiating siponimod treatment.
Croatian: • Napravite testove jetrene funkcije prije započinjanja liječenja siponimodom.
English: If any of these side effects becomes severe, tell your doctor or pharmacist.
Croatian: Ako bilo koja od ovih nuspojava postane teška, obavijestite svog liječnika ili ljekarnika.
English: • Be vigilant for skin malignancies while on treatment with siponimod.
Croatian: • Budite oprezni radi uočavanja kožnih zloćudnih bolesti tijekom liječenja siponimodom.
English: The recommended maintenance dose is 1 mg daily in patients with a CYP2C9*2*3 genotype (1.4-1.7% of the population) and in patients with a *1*3 genotype (9-12% of the population) to avoid increased exposure to siponimod (see sections 4.2 and 5.2).
Croatian: Preporučena doza održavanja je 1 mg dnevno u bolesnika s genotipom CYP2C9*2*3 (1,4-1,7% populacije) te u bolesnika s genotipom *1*3 (9-12% populacije) kako bi se izbjegla povećana izloženost siponimodu (vidjeti dijelove 4.2 i 5.2).
English: Due to risk for the foetus, siponimod is contraindicated during pregnancy and in women of childbearing potential not using effective contraception.
Croatian: Zbog rizika za fetus siponimod je kontraindiciran tijekom trudnoće i u žena reproduktivne dobi koje ne upotrebljavaju učinkovitu kontracepciju.
English: The possibility of severe exacerbation of disease after stopping siponimod treatment should be considered.
Croatian: Potrebno je uzeti u obzir mogućnost teške egzacerbacije bolesti nakon prekida liječenja siponimodom.
English: Women of childbearing potential must use effective contraception during treatment and for at least ten days following the last dose of siponimod (see section 4.4).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja te najmanje deset dana nakon posljednje doze siponimoda (vidjeti dio 4.4).
English: Patient/Caregiver Guide:
Croatian: Vodič za bolesnika/skrbnika:
English: If PML is suspected, treatment should be suspended until PML has been excluded.
Croatian: Ako se sumnja na PML, liječenje je potrebno prekinuti dok se ne isključi PML.
English: Patients treated with siponimod should be cautioned against exposure to sunlight without protection.
Croatian: Bolesnike liječene siponimodom je potrebno upozoriti da se ne izlažu sunčevom svjetlu bez zaštite.
English: How Mayzent works
Croatian: Kako djeluje Mayzent
English: Macular oedema
Croatian: Makularni edem
English: Siponimod has not been studied in combination with antineoplastic, immune-modulating or immunosuppressive therapies.
Croatian: Siponimod nije bio ispitivan u kombinaciji s antineoplastičnim, imunomodulacijskim ili imunosupresivnim terapijama.
English: Siponimod is contraindicated in patients with severe liver impairment (Child-Pugh class C).
Croatian: Siponimod je kontraindiciran u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
English: Key secondary endpoints were time to 3-month confirmed worsening of at least 20% from baseline in the timed 25-foot walk test (T25W) and change from baseline in T2 lesion volume.
Croatian: Ključne mjere sekundarnog ishoda bile su vrijeme do 3-mjesečnog potvrđenog pogoršanja od najmanje 20% u odnosu na početni rezultat na testu hodanja uz mjerenje vremena (engl. timed 25-foot walk test, T25W) te promjena volumena T2 lezija u odnosu na početni.
English: Initiation of treatment should be delayed in patients with severe active infection until resolution.
Croatian: Potrebno je odgoditi početak liječenja u bolesnika s teškom aktivnom infekcijom dok se ona ne izliječi.
English: Before initiation of treatment with siponimod, patients should be genotyped for CYP2C9 to determine their CYP2C9 metaboliser status (see section 4.2).
Croatian: Prije početka liječenja siponimodom bolesnicima se mora genotipizirati CYP2C9 kako bi se odredio njihov CYP2C9 metabolizatorski status (vidjeti dio 4.2).
English: - if you have ever had progressive multifocal leukoencephalopathy or cryptococcal meningitis.
Croatian: - ako imate sindrom imunodeficijencije. - ako ste ikad imali progresivnu multifokalnu leukoencefalopatiju ili kriptokokni meningitis.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava, nuspojave su poredane po učestalosti, počevši od najučestalijih.
English: • Do not prescribe siponimod in patients homozygous for CYP2C9*3*3.
Croatian: • Nemojte propisati siponimod bolesnicima koji su homozigotni za CYP2C9*3*3.
English: Continuation of siponimod therapy in patients with macular oedema has not been evaluated.
Croatian: Nastavak terapije siponimodom u bolesnika s makularnim edemom nije bio ocjenjivan.
English: • Arrange an ophthalmological evaluation prior to initiating therapy and follow-up evaluations while receiving therapy in patients with a history of diabetes mellitus, uveitis or underlying/co-existing retinal disease.
Croatian: • Dogovorite oftalmološki pregled prije započinjanja terapije i naknadne kontrole tijekom primanja terapije u bolesnika koji u anamnezi imaju šećernu bolest, uveitis ili osnovnu/istodobnu bolest mrežnice.
English: With decreased CYP2C9 metabolic activity in the respective genotypes, a larger effect of the CYP3A4 perpetrators on siponimod exposure is anticipated (see section 4.5).
Croatian: Uz smanjenu metaboličku aktivnost CYP2C9 u navedenim genotipovima, predviđa se veći učinak CYP3A4 inhibitora i induktora na izloženost siponimodu (vidjeti dio 4.5).
English: • Women of childbearing potential must use effective contraception during treatment and for at least 10 days following discontinuation of treatment with siponimod.
Croatian: • Žene reproduktivne dobi moraju upotrebljavati učinkovitu kontracepciju tijekom liječenja i još najmanje 10 dana nakon prekida liječenja siponimodom.
English: The pregnancy-specific patient reminder card shall contain the following key messages:
Croatian: Kartica s podsjetnikom o trudnoći mora sadržavati sljedeće ključne poruke:
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.
Croatian: Kategorijska analiza nije otkrila nikakve vrijednosti QTc intervala tijekom liječenja iznad 480 ms, nikakva povišenja QTc intervala u odnosu na početni za više od 60 ms i nikakvu korigiranu ili nekorigiranu vrijednost QT/QTc intervala koja je premašivala 500 ms.
English: CYP2C9 is a polymorphic enzyme and the drug-drug interaction (DDI) effect in the presence of CYP3A or CYP2C9 perpetrator drugs is predicted to be dependent on the CYP2C9 genotype.
Croatian: CYP2C9 je polimorfni enzim i predviđa se da će učinak interakcija između lijekova (engl. drug-drug interaction, DDI) u prisutnosti lijekova induktora ili inhibitora CYP3A ili CYP2C9 biti ovisan o genotipu CYP2C9.
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.
Croatian: Međutim, rezidualni farmakodinamički učinci, kao što su učinci snižavanja broja perifernih limfocita, mogu potrajati do 3-4 tjedna nakon posljednje doze.
English: Experience is limited in patients receiving concurrent therapy with heart-rate-lowering calcium channel blockers (such as verapamil or diltiazem) or other substances that may decrease heart rate (e.g. ivabradine or digoxin) as these medicinal products were not studied in patients receiving siponimod in clinical studies.
Croatian: Iskustvo je ograničeno u bolesnika koji primaju istodobnu terapiju blokatorima kalcijevih kanala koji smanjuju srčanu frekvenciju (kao što su verapamil ili diltiazem) ili drugim tvarima koje mogu smanjiti srčanu frekvenciju (npr. ivabradin ili digoksin) zato što ti lijekovi nisu bili ispitivani u bolesnika koji su primali siponimod u kliničkim ispitivanjima.
English: Proportion of patients with 3-month confirmed disability progression (primary endpoint) Risk reduction
Croatian: Udio bolesnika s 3-mjesečnom potvrđenom progresijom onesposobljenosti (mjera primarnog ishoda)
English: Time to onset of 3-month and 6-month CDP was significantly delayed in siponimod-treated patients with active disease, by 31% compared to placebo (hazard ratio [HR] 0.69; 95% CI: 0.53, 0.91) and by 37% compared to placebo (HR 0.63; 95% CI: 0.47, 0.86), respectively.
Croatian: Vrijeme do nastupa 3-mjesečnog i 6-mjesečnog CDP-a bilo je značajno odgođeno u bolesnika liječenih siponimodom s aktivnom bolešću, za 31% u usporedbi s placebom (omjer hazarda [HR] 0,69; 95% CI: 0,53; 0,91) odnosno za 37% u usporedbi s placebom (HR 0,63; 95% CI: 0,47; 0,86).
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.
Croatian: • bolesnika koji u anamnezi imaju atrioventrikularni (AV) blok drugog stupnja Mobitz tip II, AV blok trećeg stupnja, sinoatrijski srčani blok ili sindrom bolesnog sinusa, ako ne nose elektrostimulator srca.
English: Patients with symptoms and signs consistent with CM should undergo prompt diagnostic evaluation.
Croatian: Bolesnici sa simptomima i znakovima koji ukazuju na KM trebaju odmah biti upućeni na dijagnostičku obradu.
English: • Provide patients with the Patient/Caregiver Guide and Pregnancy Reminder Card for women of childbearing potential.
Croatian: Vodič za bolesnika/skrbnika i Karticu s podsjetnikom o trudnoći za žene reproduktivne dobi.
English: The use of live attenuated vaccines should be avoided while patients are taking siponimod and for 4 weeks after stopping treatment (see section 4.5).
Croatian: Potrebno je izbjegavati primjenu živih atenuiranih cjepiva dok bolesnici uzimaju siponimod te 4 tjedna nakon prekida liječenja (vidjeti dio 4.5).
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.
Croatian: Istodobna primjena flukonazola (umjerenog CYP2C9/snažnog CYP3A4 inhibitora) 200 mg dnevno u stanju dinamičke ravnoteže te jednokratne doze od 4 mg siponimoda u zdravih dobrovoljaca s genotipom CYP2C9*1*1 dovelo je do dvostrukog povećanja u površini ispod krivulje (AUC) siponimoda.
English: Mayzent contains the active substance siponimod.
Croatian: Mayzent sadrži djelatnu tvar siponimod.
English: The co-administration of siponimod 2 mg daily in the presence of 600 mg daily doses of rifampin (strong CYP3A4 and moderate CYP2C9 inducer) decreased siponimod AUCtau,ss and Cmax,ss by 57% and 45%, respectively, in CY2C9*1*1 subjects.
Croatian: Istodobna primjena siponimoda 2 mg dnevno u prisutnosti dnevnih doza rifampina (snažnog CYP3A4 i umjerenog CYP2C9 induktora) od 600 mg smanjila je AUCtau,ss siponimoda za 57% i Cmax,ss za 45% u ispitanika s genotipom CY2C9*1*1.
English: In the phase III clinical study in patients with SPMS the overall rate of infections was comparable between the patients on siponimod and those on placebo (49.0% versus 49.1%, respectively).
Croatian: U kliničkom ispitivanju faze III u bolesnika s SPMS-om ukupna stopa infekcija bila je usporediva između bolesnika na siponimodu i onih koji su primali placebo (49,0% u odnosu na 49,1%).
English: The mean half-life of siponimod was unchanged in hepatic impairment.
Croatian: Srednji poluvijek siponimoda bio je nepromijenjen kod oštećenja funkcije jetre.
English: PBPK modelling indicates a differential CYP2C9 genotype-dependent inhibition and induction of CYP3A4 pathways.
Croatian: PBPK modeliranje ukazuje na diferencijalnu inhibiciju i indukciju CYP3A4 puteva ovisnu o genotipu CYP2C9.
English: Stopping siponimod therapy
Croatian: Prekid terapije siponimodom
English: If a woman becomes pregnant while on treatment, siponimod must be discontinued.
Croatian: Ako žena zatrudni tijekom liječenja, primjena siponimoda mora se prekinuti.
English: • If a woman becomes pregnant while on treatment with siponimod, treatment must be discontinued.
Croatian: • Ako žena zatrudni tijekom liječenja siponimodom, liječenje se mora prekinuti.
English: It is recommended that siponimod be discontinued if a patient develops macular oedema.
Croatian: Preporučuje se prekid terapije siponimodom ako se u bolesnika razvije makularni edem.
English: Cutaneous neoplasms
Croatian: Kožne neoplazme
English: Your doctor may want to vaccinate you against chickenpox before you start treatment.
Croatian: Vaš će liječnik možda zatražiti da se cijepite protiv vodenih kozica prije nego počnete liječenje.
English: Macular oedema was more frequently reported in patients receiving siponimod (1.8%) than in those given placebo (0.2%).
Croatian: Makularni edem bio je češće prijavljen u bolesnika koji su primali siponimod (1,8%) nego u onih koji su primali placebo (0,2%).
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.
Croatian: Vaše lijekove jer bi Vam i Mayzent mogao usporiti otkucaje srca u prvih nekoliko dana liječenja.
English: Nausea Diarrhoea Musculoskeletal and connective tissue disorders Common
Croatian: Mučnina Proljev Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često