FrancophonIA/ELRC3.0 huggingface dataset:
English: Specialised pre-natal monitoring will be performed.
Croatian: Provest će se posebno prenatalno praćenje.
English: Patients above 61 years of age were not included.
Croatian: Bolesnici u dobi iznad 61 godine nisu bili uključeni.
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.
Croatian: Manja smanjenja vrijednosti forsiranog ekspiratornog volumena u prvoj sekundi (FEV1) i difuzijskog kapaciteta za ugljikov monoksid (DLCO) bila su opažena uz liječenje siponimodom.
English: No data are available for concomitant use of these medicinal products with siponimod.
Croatian: Nema dostupnih podataka o istodobnoj primjeni tih lijekova sa siponimodom.
English: MRI evaluations were performed at screening and every 12 months.
Croatian: Evaluacije MR-om bile su obavljene na probiru te svakih 12 mjeseci.
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).
Croatian: Dodatne mjere sekundarnog ishoda uključivale su vrijeme do 6-mjesečnog CDP-a, postotak promjene volumena mozga i mjere aktivnosti upalne bolesti (anualizirana stopa relapsa, lezije na MR-u).
English: • Patients need to have chickenpox vaccination 1 month before starting siponimod treatment, if the patient is not protected against the virus.
Croatian: • Bolesnici se trebaju cijepiti protiv vodenih kozica 1 mjesec prije početka liječenja siponimodom, ako bolesnik nije zaštićen od virusa.
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.
Croatian: Kod prijelaza s drugih terapija koje modificiraju tijek bolesti, moraju se razmotriti poluvijek i način djelovanja druge terapije kako bi se izbjegao aditivni imunološki učinak te istovoremeno minimalizirao rizik od reaktivacije bolesti.
English: Use of siponimod in these patients results in substantially elevated siponimod plasma levels.
Croatian: Primjena siponimoda u tih bolesnika rezultira znatno povišenim razinama siponimoda u plazmi.
English: The main target organs of toxicity in rodents included the lung, liver, thyroid, kidney and uterus/vagina.
Croatian: Glavni ciljni organi toksičnosti u glodavaca uključivali su pluća, jetru, štitnjaču, bubreg i uterus/vaginu.
English: o Extend heart rate monitoring for at least overnight in a medical facility and until resolution of findings in patients requiring pharmacological intervention during monitoring at treatment initiation/re-initiation.
Croatian: o Produžiti praćenje srčane frekvencije najmanje preko noći u medicinskoj ustanovi te do povlačenja nalaza u bolesnika kojima je potrebna farmakološka intervencija tijekom praćenja kod započinjanja/ponovnog započinjanja liječenja.
English: Study month
Croatian: Mjesec ispitivanja
English: If you forget to take Mayzent for 4 or more days in a row, call your doctor before you take the next dose.
Croatian: Ako zaboravite uzeti Mayzent 4 ili više dana uzastopno, obavijestite svog liječnika prije nego što uzmete sljedeću dozu.
English: As cases of macular oedema have also occurred on longer-term treatment, patients should report visual disturbances at any time while on siponimod therapy and an evaluation of the fundus, including the macula, is recommended.
Croatian: Budući da su se slučajevi makularnog edema također pojavili tijekom dugoročnog liječenja, bolesnici trebaju prijaviti poremećaje vida u bilo kojem trenutku za vrijeme terapije siponimodom te se preporučuje pregled očne pozadine, uključujući i makulu.
English: Initiation of treatment may result in decreased heart rate and indirect prolongation of the QT interval during the titration phase.
Croatian: Početak liječenja može rezultirati smanjenom srčanom frekvencijom i neizravnim produljenjem QT intervala tijekom faze titracije.
English: • Patients should report immediately symptoms indicating low heart rate (such as dizziness, vertigo, nausea or palpitations) after the first dose of siponimod and during the titration period.
Croatian: • Bolesnici trebaju odmah prijaviti simptome koji ukazuju na nisku srčanu frekvenciju (kao što su omaglica, vrtoglavica, mučnina ili palpitacije) nakon prve doze siponimoda i tijekom razdoblja titracije.
English: • The importance of reporting adverse reactions.
Croatian: • Važnost prijavljivanja nuspojava.
English: Therefore the efficacy of the investigated oral contraceptive was maintained under siponimod treatment.
Croatian: Stoga se djelotvornost ispitivanog oralnog kontraceptiva održala tijekom liječenja siponimodom.
English: Your doctor will advise you on this if this is relevant for you.
Croatian: Liječnik će Vas savjetovati vezano uz to, u slučaju da se to odnosi na Vas.
English: The test identifies two variant alleles for CYP2C9: CYP2C9*2 (rs1799853, c.430C>T) and CYP2C9*3 (rs1057910, c.1075A>C).
Croatian: Testom se utvrđuju dva varijantna alela za CYP2C9: CYP2C9*2 (rs1799853, c.430C>T) i CYP2C9*3 (rs1057910, c.1075A>C).
English: The exposure levels (AUC) at the respective NOAELs for embryofoetal (rats and rabbits) and pre/postnatal (rats) development were below the human systemic exposure (AUC) at a daily dose of 2 mg and consequently no safety margin exists.
Croatian: Razine izloženosti (AUC) pri odgovarajućim NOAEL vrijednostima za embriofetalni (štakori i kunići) i pre-/postnatalni (štakori) razvoj bili su ispod sistemske izloženosti u ljudi (AUC) pri dnevnoj dozi od 2 mg i stoga ne postoji sigurnosna granica.
English: Dizziness Seizure Tremor
Croatian: Omaglica Napadaj Tremor
English: Reduction of the peripheral blood lymphocytes
Croatian: Smanjenje limfocita u perifernoj krvi
English: Siponimod was not studied in patients with significant QT prolongation (QTc >500 msec) or who were treated with QT-prolonging medicinal products.
Croatian: Siponimod nije bio ispitivan u bolesnika sa značajnim produljenjem QT intervala (QTc >500 msec) ili onih koji su bili liječeni lijekovima koji produljuju QT interval.
English: Therefore, patients should not drive or use machines during the first day of treatment initiation with siponimod (see section 4.4).
Croatian: Stoga, bolesnici ne smiju upravljati vozilima ili raditi sa strojevima tijekom prvog dana započinjanja liječenja siponimodom (vidjeti dio 4.4).
English: During and for up to 4 weeks after stopping treatment with Mayzent, you should not be given certain types of vaccine (called live attenuated vaccines) as they could trigger the infection that they were supposed to prevent (see section 2).
Croatian: Tijekom liječenja te do 4 tjedna nakon prestanka liječenja Mayzentom ne biste smjeli primati neke vrste cjepiva (koja se nazivaju živim atenuiranim cjepivima) jer bi ona mogla izazvati infekciju koju bi inače trebala spriječiti (vidjeti dio 2.).
English: • Rash with small fluid-filled blisters, appearing on reddened skin (symptoms of a viral infection called herpes zoster that can be severe)
Croatian: • Osip s mjehurićima ispunjenima tekućinom, koji se pojavljuju na crvenoj koži (simptomi virusne infekcije zvane herpes zoster, a koja može biti teška)
English: Discontinuation of treatment 1 week prior to planned vaccination until 4 weeks after is recommended.
Croatian: Preporučuje se prekinuti liječenje 1 tjedan prije planiranog cijepljenja do 4 tjedna nakon njega.
English: Your doctor will need to prescribe a new titration pack and you will have to restart treatment at day 1.
Croatian: Liječnik će Vam morati propisati novo pakiranje za titraciju i morat ćete ponovno početi liječenje od 1. dana.
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).
Croatian: Nekoliko je bolesnika osjetilo blage do umjerene simptome uključujući omaglicu i bol nesrčanog podrijetla u grudnom košu, koji su se povukli u roku od 24 sata bez intervencije (vidjeti dio 4.8).
English: Your doctor will need to prescribe a new titration pack.
Croatian: Liječnik će Vam morati propisati novo pakiranje za titraciju.
English: • Siponimod is not recommended in patients with cardiac disease or taking concomitant medicines known to decrease heart rate.
Croatian: • Siponimod se ne preporučuje u bolesnika sa srčanom bolešću ili onih koji istodobno uzimaju lijekove za koje je poznato da smanjuju srčanu frekvenciju.
English: An ophthalmological evaluation is therefore recommended 3-4 months after treatment initiation.
Croatian: Zato se preporučuje oftalmološka evaluacija 3-4 mjeseca nakon početka liječenja.
English: Your white blood cell (lymphocyte) count may remain low for up to 3 to 4 weeks after you stop taking Mayzent.
Croatian: Broj bijelih krvnih stanica (limfocita) može ostati nizak 3 do 4 tjedna nakon što prestanete uzimati Mayzent.
English: If tested negative, vaccination is recommended and treatment with siponimod should be postponed for 1 month to allow the full effect of vaccination to occur.
Croatian: Ako je test negativan, preporučuje se cijepljenje i početak liječenja treba odgoditi za 1 mjesec kako bi se omogućio puni učinak cijepljenja.
English: An apparent systemic clearance (CL/F) of 3.11 l/h was estimated in MS patients.
Croatian: Prividni sistemski klirens (CL/F) od 3,11 l/h bio je procijenjen u bolesnika s MS-om.
English: Mayzent lowers the number of white cells in your blood.
Croatian: Mayzent smanjuje broj bijelih krvnih stanica.
English: • Physician's Checklist to consider prior to prescribing Mayzent;
Croatian: • Kontrolni popis za liječnika koji treba provjeriti prije propisivanja Mayzenta;
English: • Patients will be informed by their doctor of the need for effective contraception while on treatment and for 10 days after discontinuation.
Croatian: • Bolesnice će informirati njihov liječnik o potrebi za učinkovitom kontracepcijom za vrijeme liječenja i 10 dana nakon prestanka liječenja.
English: Treatment with Mayzent will be overseen by a doctor who is experienced in the treatment of MS.
Croatian: Liječenje Mayzentom nadzirat će liječnik koji ima iskustva u liječenju MS-a.
English: The negative chronotropic effect of co-administration of siponimod and propranolol was evaluated in a dedicated pharmacodynamic/safety study.
Croatian: Negativan kronotropni učinak istodobne primjene siponimoda i propranolola bio je ocjenjivan u posebnom ispitivanju farmakodinamike/sigurnosti.
English: Difference in T2 lesion volume change
Croatian: Razlika u promjeni volumena T2 lezija
English: • For patients with certain heart problems, an ECG before initiating treatment with siponimod will be needed.
Croatian: • Za bolesnike s određenim srčanim problemima bit će potrebno napraviti EKG prije početka liječenja.
English: These observations were slightly higher (approximately 0.15 L mean change from baseline in FEV1) in patients with respiratory disorders such as chronic obstructive pulmonary disease (COPD) or asthma treated with siponimod.
Croatian: Ta su opažanja bila nešto veća (srednja promjena FEV1 otprilike 0,15 L u odnosu na početnu vrijedost) u bolesnika s respiratornim poremećajima poput kronične opstruktivne plućne bolesti (KOPB) ili astme liječenih siponimodom.
English: Treatment with siponimod should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
Croatian: Liječenje siponimodom mora započeti i nadgledati liječnik s iskustvom u liječenju multiple skleroze.
English: • medicines for an irregular heartbeat, such as amiodarone, procainamide, quinidine or sotalol.
Croatian: • lijekove za nepravilne otkucaje srca, kao što su amiodaron, prokainamid, kinidin ili sotalol.
English: After the first titration dose, the heart rate decrease starts within one hour and the day 1 decline is maximal at approximately 3 to 4 hours.
Croatian: Nakon prve titracijske doze smanjenje srčane frekvecije započinje u roku od jedan sat i smanjenje 1. dana doseže maksimum nakon otprilike 3 do 4 sata.
English: Treatment needs to be reinitiated with a new titration pack.
Croatian: Liječenje je potrebno ponovno započeti s novim pakiranjem za titraciju.
English: However, other skin malignancies, including melanoma, have also been reported in patients treated with siponimod and in patients on long-term therapy with another S1P modulator.
Croatian: Međutim, druge kožne zloćudne bolesti, uključujući melanom, također su bile prijavljene u bolesnika liječenih siponimodom te u bolesnika na dugoročnoj terapiji nekim drugim S1P modulatorom.
English: The chance of developing macular oedema (see above) is higher in patients with diabetes.
Croatian: Mogućnost razvoja makularnog edema (vidjeti gore) veća je u oboljelih od šećerne bolesti.
English: • Perform genotyping for CYP2C9 before treatment initiation to determine the siponimod maintenance dose.
Croatian: • Genotipizirati CYP2C9 prije početka liječenja kako bi se odredila doza održavanja za siponimod.
English: - During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6).
Croatian: - Tijekom trudnoće i u žena reproduktivne dobi koje ne upotrebljavaju učinkovitu kontracepciju (vidjeti dijelove 4.4 i 4.6).
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).
Croatian: • ako ste ikad imali bilo koje od sljedećih stanja (čak i ako primate terapiju za njih): teška bolest srca, nepravilni ili poremećeni otkucaji srca (aritmija), moždani udar ili druga bolest povezana s krvnim žilama u mozgu, usporeni puls, nesvjestica, poremećaj srčanog ritma (na što upućuju odstupanja u EKG-u).
English: • Liver function tests should be performed before starting treatment and repeated if there are symptoms suggestive of hepatic dysfunction.
Croatian: • Treba napraviti testove funkcije jetre prije početka liječenja i ponoviti ih ako se pojave simptomi koji upućuju na jetrenu disfunkciju.
English: • Report immediately to the prescribing physician any (intended or unintended) pregnancy, during treatment and up to 10 days following discontinuation of siponimod treatment.
Croatian: • Odmah prijaviti liječniku koji je propisao lijek svaku (planiranu ili neplaniranu) trudnoću, tijekom liječenja i do 10 dana nakon prestanka primjene siponimoda.
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.
Croatian: Ponovni nastavak terapije ovisit će o tome utvrdi li se neki drugi uzrok oštećenja jetre te o koristima nastavka terapije za bolesnika u odnosu na rizike ponovne pojave jetrene disfunkcije.
English: Pulmonary function
Croatian: Plućna funkcija
English: This is due to the reversible sequestration of lymphocytes in lymphoid tissues (see section 5.1).
Croatian: To je uzrokovano reverzibilnom sekvestracijom limfocita u limfoidnim tkivima (vidjeti dio 5.1).
English: • The other ingredients are: Tablet core: Lactose monohydrate (see “Mayzent contains lactose”), microcrystalline cellulose, crospovidone, glycerol dibehenate, colloidal anhydrous silica.
Croatian: • Drugi sastojci su: Jezgra tablete: laktoza hidrat (vidjeti „Mayzent sadrži laktozu“), mikrokristalična celuloza, krospovidon, gliceroldibehenat, koloidni bezvodni silicijev dioksid.
English: Blood pressure should be regularly monitored during treatment with siponimod.
Croatian: Potrebno je redovito pratiti krvni tlak tijekom liječenja siponimodom.
English: • Patients must use effective contraception during the treatment with siponimod.
Croatian: • Bolesnici moraju koristiti učinkovitu kontracepciju tijekom liječenja siponimodom.
English: A core pharmacodynamic effect of siponimod is a dose-dependent reduction of the peripheral lymphocyte count to 20-30% of baseline values.
Croatian: Osnovni je farmakodinamički učinak siponimoda o dozi ovisno smanjenje broja perifernih limfocita na 20-30% početnih vrijednosti.
English: On chronic treatment, this reduction did not translate into clinically significant adverse events and was not associated with an increase in reports of cough or dyspnoea (see section 5.1).
Croatian: Kod kroničnog liječenja to smanjenje nije uzrokovalo klinički značajne nuspojave te nije bilo povezano s povećanim brojem prijavljenih slučajeva kašlja ili dispneje (vidjeti dio 5.1).
English: Results from the study showed a variable but consistent risk reduction in the time to 3- and 6-month CDP with siponimod compared to placebo in subgroups defined based on gender, age, pre-study relapse activity, baseline MRI disease activity, disease duration and disability levels at baseline.
Croatian: Rezultati ispitivanja pokazali su varijabilno ali dosljedno smanjenje rizika u vremenu do 3-mjesečnog i 6-mjesečnog CDP-a uz siponimod u usporedbi s placebom u podskupinama definiranim na temelju spola, dobi, aktivnosti relapsa prije ispitivanja, početne aktivnosti bolesti na MR-u, trajanja bolesti i razina onesposobljenosti na početku.
English: What Mayzent is and what it is used for
Croatian: Što je Mayzent i za što se koristi
English: Siponimod should be used with caution in the elderly (see section 4.2).
Croatian: Siponimod se mora upotrebljavati oprezno u starijih (vidjeti dio 4.2).
English: Consequently, siponimod is contraindicated during pregnancy (see section 4.3).
Croatian: Posljedično tome, siponimod je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: Siponimod should be stopped at least 10 days before a pregnancy is planned (see section 4.4).
Croatian: Potrebno je prekinuti primjenu siponimoda najmanje 10 dana prije no što se planira trudnoća (vidjeti dio 4.4).
English: Heart rate and rhythm
Croatian: Srčana frekvencija i ritam
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Mayzent Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
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%).
Croatian: Liječenje siponimodom s jednokratnom ili višestrukim dozama tijekom 28 dana nije povezano s klinički relevantnim povećanjima u otporu dišnih puteva mjerenom forsiranim ekspiratornim volumenom u prvoj sekundi (FEV1) i forsiranim ekspiratornim protokom (FEF) tijekom ekspiracije 25 do 75% forsiranog vitalnog kapaciteta (FEF25-75%).
English: • Patients should inform their doctor straight away if there is worsening of multiple sclerosis after stopping treatment with siponimod.
Croatian: • Bolesnici trebaju odmah informirati svog liječnika ako nastupi pogoršanje multiple skleroze nakon prestanka primjene siponimoda.
English: In the extension part of the phase III clinical study, a case of cryptococcal meningitis (CM) has been reported (see section 4.4).
Croatian: U produžetku kliničkog ispitivanja faze III bio je prijavljen slučaj kriptokoknog meningitisa (KM) (vidjeti dio 4.4).
English: Siponimod did not affect male and female fertility in rats up to the highest dose tested, representing an approximate 19-fold safety margin based on human systemic exposure (AUC) at a daily dose of 2 mg.
Croatian: Siponimod nije utjecao na plodnost mužjaka i ženki štakora do najviše ispitivane doze, što predstavlja približno 19 puta veću sigurnosnu granicu na temelju sistemske izloženosti ljudi (AUC) pri dnevnoj dozi od 2 mg.
English: Although no dose adjustment is needed in patients with mild or moderate hepatic impairment, caution should be exercised when initiating treatment in these patients (see sections 4.4 and 5.2).
Croatian: Iako nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem jetre, potreban je oprez kod započinjanja liječenja u tih bolesnika (vidjeti dijelove 4.4 i 5.2).
English: • phototherapy with UV radiation or PUVA photochemotherapy.
Croatian: • fototerapiju UV zračenjem ili PUVA fotokemoterapiju.
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.
Croatian: • Liječnici će pružiti savjetovanje prije početka liječenja i redovito nakon toga o potencijalnom teratogenom riziku siponimoda i potrebnim radnjama da se taj rizik minimizira.
English: However, an increase in the rate of herpes zoster infections was reported on siponimod (2.5%) compared to placebo (0.7%).
Croatian: Međutim, prijavljeno je povećanje stope herpes zoster infekcija uz siponimod (2,5%) u usporedbi s placebom (0,7%).
English: Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity (see section 5.1).
Croatian: Mayzent je indiciran za liječenje odraslih bolesnika sa sekundarno progresivnom multiplom sklerozom (SPMS) s aktivnom bolešću potvrđenom relapsima ili nalazima upalne aktivnosti na slikovnim pretragama (vidjeti dio 5.1).
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.
Croatian: • Bolesnici trebaju temeljito pročitati uputu o lijeku prije započinjanja liječenja i čuvati uputu o lijeku u slučaju da im ponovo zatreba tijekom liječenja.
English: An up-titration regimen is used to reach the clinically therapeutic dose of 2 mg siponimod after 6 days and 4 additional days of dosing are required to reach the steady-state plasma concentrations.
Croatian: Režim postpunog povećanja doze koristi se da bi se postigla klinički terapijska doza od 2 mg siponimoda nakon 6 dana, a 4 dodatna dana doziranja potrebna su da bi se postigle koncentracije u plazmi u stanju dinamičke ravnoteže.
English: Since initiation of treatment results in decreased heart rate, siponimod should not be used concomitantly with these medicinal products during treatment initiation.
Croatian: Budući da započinjanje liječenja rezultira smanjenom srčanom frekvencijom, siponimod se ne smije koristiti istodobno s tim lijekovima tijekom započinjanja liječenja.
English: • Siponimod is contraindicated in patients with immunodeficiency syndrome.
Croatian: • Siponimod je kontraindiciran u bolesnika sa sindromom imunodeficijencije.
English: • Titration pack as wallet containing 12 tablets, and
Croatian: • Pakiranje za titraciju kao ovitak u obliku novčanika koji sadrži 12 tableta i
English: Due to the risk of serious cardiac rhythm disturbances or significant bradycardia, siponimod should not be used in patients with: - history of symptomatic bradycardia or recurrent syncope, - uncontrolled hypertension, or - severe untreated sleep apnoea.
Croatian: Zbog rizika od ozbiljnih poremećaja srčanog ritma ili značajne bradikardije, siponimod se ne smije koristiti u bolesnika koji imaju: - simptomatsku bradikardiju ili rekurentnu sinkopu u anamnezi, - nekontroliranu hipertenziju, ili - tešku neliječenu apneju u snu.
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.
Croatian: 9/l, potrebno je smanjiti dozu na 1 mg, zato što je u kliničkim ispitivanjima doza siponimoda bila smanjena u bolesnika s apsolutnim brojem limfocita <0,2 x 10