FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients who, in the previous 6 months, had a myocardial infarction, unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring in-patient treatment), or New York Heart Association (NYHA) class III/IV heart failure.
Croatian: • bolesnika koji su u prethodnih 6 mjeseci imali infarkt miokarda, nestabilnu anginu pektoris, moždani udar/tranzitornu ishemijsku ataku (TIA), dekompenzirano zatajenje srca (koje zahtijeva bolničko liječenje), ili zatajenje srca NYHA (New York Heart Association) klase III/IV.
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.
Croatian: U takvih se bolesnika liječenje siponimodom treba razmotriti samo ako su očekivane koristi veće od potencijalnih rizika te je potrebno zatražiti savjet kardiologa prije početka liječenja kako bi se odredila najprimjerenija strategija praćenja.
English: 9/l in a patient already receiving siponimod 1 mg should lead to interruption of siponimod therapy until the level reaches 0.6 x 10 9/l when re-initiation of siponimod can be considered.
Croatian: 9/l u bolesnika koji već prima siponimod 1 mg, potrebno je prekinuti terapiju siponimodom dok razina ne dosegne 0,6 x 10
English: - Hypersensitivity to the active substance, or to peanut, soya or any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar, ili na kikiriki, soju ili neku od pomoćnih tari navedenih u dijelu 6.1. - Sindrom imunodeficijencije.
English: With continued up-titration, further heart rate decreases are seen on subsequent days, with maximal decrease from day 1 (baseline) reached on day 5 to 6.
Croatian: Uz nastavak titracije prema višoj dozi, daljnja smanjenja srčane frekvecije uočavaju se u narednim danima, pri čemu se maksimalno smanjenje u odnosu na 1. dan (početak) postiže 5. do 6. dana.
English: CYP2C9 and CYP3A4 inducers
Croatian: CYP2C9 i CYP3A4 induktori
English: After stopping siponimod treatment residual lowering effects on peripheral lymphocyte count may persist for up to 3-4 weeks after the last dose.
Croatian: Nakon prekida liječenja siponimodom rezidualni učinci snižavanja broja perifernih limfocita mogu se zadržati do 3-4 tjedna nakon posljednje doze.
English: Siponimod treatment should be considered in these patients only if the anticipated benefits outweigh the potential risks and a cardiologist must be consulted to determine appropriate monitoring.
Croatian: Liječenje siponimodom u tih bolesnika treba razmotriti samo ako očekivane koristi premašuju moguće rizike te je potrebno zatražiti savjet kardiologa kako bi se odredila primjerena strategija praćenja.
English: % of CYP2C9*1*1 CL/F
Croatian: % od CYP2C9*1*1 CL/F
English: What Mayzent is used for
Croatian: Za što se Mayzent koristi
English: Siponimod is metabolised primarily by cytochrome P450 2C9 (CYP2C9) (79.3%) and to a lesser extent by cytochrome P450 3A4 (CYP3A4) (18.5%).
Croatian: Siponimod se metabolizira prvenstveno putem citokroma P450 2C9 (CYP2C9) (79,3%) i u manjoj mjeri putem citokroma P450 3A4 (CYP3A4) (18,5%).
English: No siponimod dose adjustments are needed in patients with mild, moderate or severe renal impairment.
Croatian: Nisu potrebne prilagodbe doze siponimoda u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega.
English: The efficacy of vaccination is not considered to be compromised if siponimod treatment is paused 1 week prior to vaccination until 4 weeks after (see section 4.4).
Croatian: Smatra se da djelotvornost cijepljenja nije ugrožena ako se liječenje siponimodom privremeno zaustavi 1 tjedan prije cijepljenja i još 4 tjedna nakon cijepljenja (vidjeti dio 4.4).
English: Pregnancy Reminder Card for women of childbearing potential:
Croatian: Kartica s podsjetnikom o trudnoći za žene reproduktivne dobi:
English: During treatment initiation siponimod should not be concomitantly used in patients receiving class Ia (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) anti-arrhythmic medicinal products, QT-prolonging medicinal products with known arrhythmogenic properties, heart-rate-lowering calcium channel blockers (such as verapamil or diltiazem) or other substances that may decrease heart rate (e.g. ivabradine or digoxin) because of the potential additive effects on heart rate (see section 4.4).
Croatian: Tijekom započinjanja liječenja siponimod se ne smije istodobno koristiti u bolesnika koji primaju antiaritmike klase Ia (npr. kinidin, prokainamid) ili klase III (npr. amiodaron, sotalol), lijekove koji produljuju QT interval s poznatim aritmogenim svojstvima, blokatore kalcijevih kanala koji smanjuju srčanu frekvenciju (kao što su verapamil ili diltiazem) ili druge tvari koje mogu smanjiti srčanu frekvenciju (npr. ivabradin ili digoksin) zbog potencijalnih aditivinih učinaka na srčanu frekvenciju (vidjeti dio 4.4).
English: Physicians should be vigilant for clinical symptoms or MRI findings suggestive of PML.
Croatian: Liječnici trebaju biti oprezni na kliničke simptome i nalaze MR-a koji upućuju na PML.
English: • A negative pregnancy test result is required prior to initiation of treatment in women of childbearing potential.
Croatian: • Rezultat testa na trudnoću mora biti negativan prije početka liječenja u žena reproduktivne dobi.
English: • Be familiar with the Mayzent Prescribing Information.
Croatian: • Trebate poznavati informacije o propisivanju Mayzenta.
English: Titration packs of 12 film-coated tablets in PA/alu/PVC/alu blister in wallet.
Croatian: Pakiranja za titraciju od 12 filmom obloženih tableta u PA/Al/PVC/Al blisteru u ovitku u obliku novčanika.
English: • Cases of progressive multifocal leukoencephalopathy (PML) have been reported with another sphingosine 1-phosphate (S1P) receptor modulator.
Croatian: • Slučajevi progresivne multifokalne leukoencefalopatije (PML) bili su prijavljeni uz drugi modulator sfingozin 1-fosfat (S1P) receptora.
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.
Croatian: Kako Mayzent izgleda i sadržaj pakiranja Mayzent 0,25 mg filmom obložene tablete su blijedo crvene, okrugle filmom obložene tablete s logotipom tvrtke s jedne strane i oznakom „T“ s druge strane.
English: If PML is suspected, siponimod treatment should be suspended until PML has been excluded.
Croatian: Ako se sumnja na PML, potrebno je prekinuti liječenje siponimodom dok se ne isključi PML.
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 (see section 4.4).
Croatian: - Bolesnici koji u anamnezi imaju atrioventrikularni (AV) blok drugog stupnja Mobitz tipa II, AV blok trećeg stupnja, sinoatrijski srčani blok ili sindrom bolesnog sinusa, ako ne nose elektrostimulator srca (vidjeti dio 4.4).
English: - Patients who in the previous 6 months had a myocardial infarction (MI), unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure (see section 4.4).
Croatian: - Bolesnici koji su u prethodnih 6 mjeseci imali infarkt miokarda (IM), nestabilnu anginu pektoris, moždani udar/tranzitornu ishemijsku ataku (TIA), dekompenzirano zatajenje srca (koje zahtijeva bolničko liječenje), ili zatajenje srca NYHA (New York Heart Association) klase III/IV (vidjeti dio 4.4).
English: Reduction in heart rate
Croatian: Smanjenje srčane frekvencije
English: - Patients homozygous for CYP2C9*3 (CYP2C9*3*3) genotype (poor metaboliser).
Croatian: - Bolesnici homozigotni za genotip CYP2C9*3 (CYP2C9*3*3) (spori metabolizatori).
English: Antineoplastic, immune-modulating or immunosuppressive therapies
Croatian: Antineoplastične, imunomodulacijske ili imunosupresivne terapije
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).
Croatian: Ako se uz siponimod istodobno primjenjuje antineoplastična, imunomodulacijska ili imunosupresivna terapija (uključujući kortikosteroide) potreban je oprez zbog rizika od aditivnih učinaka na imunološki sustav tijekom takve terapije (vidjeti dio 4.5).
English: When stopping siponimod for planning a pregnancy the possible return of disease activity should be considered.
Croatian: Kad se terapija siponimodom prekida zbog planiranja trudnoće, potrebno je imati u vidu mogući povratak aktivnosti bolesti.
English: Confirmed at 6 months [Nominal p-value for endpoints not included in the hierarchical testing and not adjusted for multiplicity]
Croatian: [Nominalna p-vrijednost za mjere ishoda koje nisu uključene u hijerarhijsko testiranje niti prilagođene za višestrukost] p vrijednost nije potvrdna; postupak hijerarhijskog testiranja završen je prije dostizanja mjere ishoda
English: For further clarifications please refer to your local laboratory.
Croatian: Za dodatna pojašnjenja potrebno je obratiti se lokanom laboratoriju.
English: How to take Mayzent
Croatian: Kako uzimati Mayzent
English: Proportion of patients with 3-month confirmed 20% increase in timed 25-foot walk test Risk reduction
Croatian: Udio bolesnika s 3-mjesečnim potvrđenim povećanjem od 20% na vremenskom testu hodanja (T25W)
English: Packs of 28 film-coated tablets in PA/alu/PVC/alu blisters.
Croatian: Pakiranja od 28 filmom obloženih tableta u PA/Al/PVC/Al blisterima.
English: Also, these patients should not receive concomitant phototherapy with UV-B radiation or PUVA-photochemotherapy.
Croatian: Također, ovi bolesnici ne smiju primati istodobnu fototerapiju s UV-B zračenjem ili PUVA-fotokemoterapiju.
English: • Women of childbearing potential should be counselled before treatment initiation and regularly thereafter about the serious risks of siponimod to the foetus, facilitated by the pregnancy-specific patient reminder card.
Croatian: • Žene reproduktivne dobi je prije započinjanja liječenja te redovno nakon toga potrebno savjetovati o ozbiljnim rizicima siponimoda za fetus, što će olakšati Kartica s podsjetnikom o trudnoći.
English: If you stop taking Mayzent Do not stop taking Mayzent or change your dose without talking to your doctor first.
Croatian: Nemojte prestati uzimati Mayzent ili promijeniti svoju dozu bez prethodnog dogovora sa svojim liječnikom.
English: Excipient with known effect Each tablet contains 59.1 mg lactose (as monohydrate) and 0.092 mg soya lecithin.
Croatian: Jedna tableta sadrži 59,1 mg laktoze (u obliku laktoze hidrata) i 0,092 mg sojinog lecitina.
English: % exposure increase versus CYP2C9*1*1
Croatian: % povećanja izloženosti u odnosu na CYP2C9*1*1
English: Siponimod must not be used in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Croatian: Siponimod se ne smije primjenjivati u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) (vidjeti dio 4.3).
English: Percentage of patients with 3-month CDP
Croatian: Postotak bolesnika s 3-mjesečnim CDP-om
English: Siponimod is a sphingosine-1-phosphate (S1P) receptor modulator.
Croatian: Siponimod je modulator sfingozin 1-fosfat (S1P) receptora.
English: If concomitant treatment with one of the above substances is considered during initiation of treatment with siponimod, advice from a cardiologist should be sought regarding the switch to a non-heart-rate-lowering medicinal product or appropriate monitoring for treatment initiation.
Croatian: Ako se razmatra istodobno liječenje jednom od gore navedenih tvari tijekom započinjanja liječenja siponimodom, potrebno je zatražiti savjet kardiologa oko prijelaza na lijek koji ne smanjuje srčanu frekvenciju ili odgovarajućeg praćenja početka liječenja.
English: The tablets contain soya lecithin.
Croatian: Tablete sadrže sojin lecitin.
English: No dose adjustments for siponimod are needed in patients with mild or moderate hepatic impairment.
Croatian: Nisu potrebne prilagodbe doze siponimoda u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
English: Prior treatment with immunosuppressive or immune-modulating therapies
Croatian: Prethodno liječenje imunosupresivnim ili imunomodulacijskim terapijama
English: • If the maintenance dose is interrupted for 4 or more consecutive daily doses, treatment must be re-initiated with a new titration pack.
Croatian: • Ako se doza održavanja prekine propuštanjem 4 ili više uzastopnih dnevnih doza, liječenje se mora ponovo započeti s novim pakiranjem za titraciju.
English: Siponimod belongs to a group of medicines called sphingosine-1-phosphate (S1P) receptor modulators.
Croatian: Siponimod pripada skupini lijekova koji se nazivaju modulatori sfingozin 1-fosfat (S1P) receptora.
English: • A pregnancy test must be carried out and negative results verified by the doctor before starting treatment.
Croatian: • Prije početka liječenja mora se napraviti test na trudnoću i negativan rezultat mora potvrditi liječnik.
English: In patients with a CYP2C9*2*3 or *1*3 genotype, the recommended maintenance dose is 1 mg taken once daily (four tablets of 0.25 mg) (see sections 4.4 and 5.2).
Croatian: U bolesnika s genotipom CYP2C9*2*3 ili *1*3 preporučena doza održavanja je 1 mg i uzima se jedanput na dan (četiri tablete od 0,25 mg) (vidjeti dijelove 4.4 i 5.2).
English: In patients with CYP2C9*2*3 or *1*3 genotype, the recommended maintenance dose is 1 mg taken once daily (4 x 0.25 mg) (see above and sections 4.4 and 5.2).
Croatian: U bolesnika s genotipom CYP2C9*2*3 ili *1*3, preporučena doza održavanja je 1 mg (4 x 0,25 mg) i uzima se jedanput na dan (vidjeti gore i dijelove 4.4 i 5.2).
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%).
Croatian: Siponimod se ekstenzivno metabolizira, uglavnom putem citokroma P450 2C9 (CYP2C9) (79,3%) te u manjoj mjeri putem citokroma P450 3A4 (CYP3A4) (18,5%).
English: Packs of 120 film-coated tablets in PA/alu/PVC/alu blisters.
Croatian: Pakiranja od 120 filmom obloženih tableta u PA/Al/PVC/Al blisterima.
English: Excipient with known effect Each tablet contains 57.3 mg lactose (as monohydrate) and 0.092 mg soya lecithin.
Croatian: Jedna tableta sadrži 57,3 mg laktoze (u obliku laktoze hidrata) i 0,092 mg sojinog lecitina.
English: Treatment initiation recommendation in patients with certain pre-existing cardiac conditions As a precautionary measure, patients with the following cardiac conditions should be observed for a period of 6 hours after the first dose of siponimod for signs and symptoms of bradycardia (see also section 4.3): - sinus bradycardia (heart rate <55 bpm), - history of first- or second-degree [Mobitz type I] AV block, - history of myocardial infarction, or - history of heart failure (patients with NYHA class I and II).
Croatian: Preporuka za početak liječenja u bolesnika s određenim već postojećim srčanim stanjima Kao mjera opreza potrebno je bolesnike sa sljedećim srčanim stanjima promatrati tijekom razdoblja od 6 sati nakon prve doze zbog mogućih znakova i simptoma bradikardije (vidjeti i dio 4.3): - sinusna bradikardija (srčana frekvencija <55 bpm), - AV blok prvog ili drugog stupnja [Mobitz tip I] u anamnezi, - infarkt miokarda u anamnezi, ili - zatajenje srca u anamnezi (bolesnici s NYHA klasom I i II).
English: Proportion of patients with 6-month confirmed disability progression
Croatian: Udio bolesnika sa 6-mjesečnom potvrđenom progresijom onesposobljenosti Smanjenje rizika
English: • Patients should report any symptoms of visual impairment immediately to the prescriber during and for up to one month after the end of treatment with siponimod.
Croatian: • Bolesnici trebaju odmah prijaviti bilo kakve simptome oštećenja vida liječniku koji je propisao lijek, tijekom liječenja te do mjesec dana nakon završetka liječenja siponimodom.
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.
Croatian: Zbog značajnog povećanja izloženosti siponimodu, ne preporučuje se istodobna primjena siponimoda i lijekova koji uzrokuju umjerenu inhibiciju CYP2C9 i umjerenu do jaku inhibiciju CYP3A4.
English: The decrease in heart rate induced by siponimod can be reversed by atropine or isoprenaline.
Croatian: Smanjenje srčane frekvencije uzrokovano siponimodom može se obrnuti atropinom ili izoprenalinom.
English: Siponimod causes a transient reduction in heart rate and atrioventricular conduction on treatment initiation (see sections 4.4 and 4.8), which is mechanistically related to the activation of G-protein-coupled inwardly rectifying potassium (GIRK) channels via S1P1 receptor stimulation leading to cellular hyperpolarisation and reduced excitability.
Croatian: Siponimod uzrokuje prolazno smanjenje srčane frekvencije i atrioventrikularnog provođenja na početku liječenja (vidjeti dijelove 4.4 i 4.8), što je mehanistički povezano s aktivacijom ulazno ispravljačkih kalijevih kanala povezanih s G proteinom (engl.
English: Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported for another sphingosine 1-phosphate (S1P) receptor modulator.
Croatian: Prijavljeni su rijetki slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES) kod primjene drugog modulatora sfingozin 1-fosfat (S1P) receptora.
English: Because of the potential additive effect on heart rate, treatment with siponimod should generally not be initiated in patients who are concurrently treated with these substances (see section 4.5).
Croatian: Zbog potencijalnog aditivnog učinka na srčanu frekveciju, liječenje siponimodom općenito se ne smije započinjati u bolesnika koji se istodobno liječe tim tvarima (vidjeti dio 4.5).
English: CYP2C9 genotype
Croatian: Genotip CYP2C9
English: These patients should not receive concomitant phototherapy with UV-B radiation or PUVA-photochemotherapy.
Croatian: Ovi bolesnici ne smiju primiti istodobnu fototerapiju UV-B zračenjem ili PUVA-fotokemoterapiju.
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.
Croatian: Mayzent 2 mg filmom obložene tablete su blijedo žute, okrugle filmom obložene tablete s logotipom tvrtke s jedne strane i oznakom „II“ s druge strane.
English: TITRATION
Croatian: TITRACIJA
English: Because of the potential additive effect on heart rate, treatment with siponimod should generally not be initiated in patients who are concurrently treated with these substances (see section 4.4).
Croatian: Zbog mogućeg aditivnog učinka na srčanu frekvenciju, liječenje siponimodom općenito se ne smije započinjati u bolesnika koji se istodobno liječe tim lijekovima (vidjeti dio 4.4).
English: o QTc prolongation >500 msec o Severe untreated sleep apnoea o History of symptomatic bradycardia o History of recurrent syncope o Uncontrolled hypertension o Concomitant treatment with class Ia (e.g. quinidine, procainamide) or class III anti-arrhythmic medications, calcium channel blockers (such as verapamil, diltiazem) and other medications (e.g. ivabradine or digoxin)
Croatian: o Produljenje QTc intervala >500 msec o Teška neliječena apneja u snu o Simptomatska bradikardija u anamnezi o Rekurentna sinkopa u anamnezi o Nekontrolirana hipertenzija o Istodobno liječenje antiaritmicima klase Ia (npr. kinidin, prokainamid) ili klase III, blokatorima kalcijevih kanala (kao što su verapamil, diltiazem) i drugim lijekovima (npr. ivabradin, digoksin) za koje je poznato da smanjuju srčanu frekvenciju
English: 5 tablets
Croatian: 5 tableta
English: • Monitoring requirements at treatment initiation: Prior to initiating treatment: o Perform vitals and baseline ECG prior to the first dose of siponimod in patients with sinus bradycardia (heart rate [HR] <55 bpm), history of first- or second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure (patients with NYHA class I and II).
Croatian: • Zahtjevi za praćenje na početku liječenja: Prije početka liječenja: o Provjeriti vitalne znakove i napraviti početni EKG prije prve doze siponimoda u bolesnika sa sinusnom bradikardijom (srčana frekvencija <55 otkucaja u minuti), AV blokom prvog ili drugog stupnja [Mobitz tip I] u anamnezi, ili infarktom miokarda ili zatajenjem srca (bolesnici s NYHA klasom I i II) u anamnezi.
English: Percentage of patients with 6-month CDP
Croatian: Postotak bolesnika sa 6-mjesečnim CDP-om
English: If treatment with siponimod is considered, advice from a cardiologist should be sought regarding the switch to non-heart-rate-lowering medicinal products or appropriate monitoring for treatment initiation.
Croatian: Ako se razmatra liječenje siponimodom, potrebno je zatražiti savjet kardiologa oko prijelaza na lijek koji ne smanjuje srčanu frekvenciju ili odgovarajućeg praćenja kod početka liječenja.
English: Your doctor may decide to keep you under observation.
Croatian: Liječnik može odlučiti držati
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(I) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Until 6 hours after first dose: o Observe patients with sinus bradycardia (heart rate <55 bpm), history of first- or second-degree [Mobitz type I] AV block or a history of myocardial infarction or heart failure (patients with NYHA class I and II) for a period of 6 hours after the first dose of siponimod for signs and symptoms of bradycardia and obtain an ECG at the end of the 6-hour monitoring period.
Croatian: Do 6 sati nakon prve doze: o Bolesnike sa sinusnom bradikardijom (srčana frekvencija <55 otkucaja u minuti) ili AV blokom prvog ili drugog stupnja [Mobitz tip I] u anamnezi ili infarktom miokarda ili zatajenjem srca (bolesnici s NYHA klasom I i II) u anamnezi promatrati tijekom razdoblja od 6 sati nakon prve doze siponimoda zbog mogućih znakova i simptoma bradikardije te napraviti EKG na kraju 6-satnog razdoblja praćenja.
English: o If necessary, the decrease in heart rate induced by siponimod can be reversed by parenteral doses of atropine or isoprenaline.
Croatian: o Ako je potrebno, smanjenje srčane frekvencije inducirano siponimodom može se poništiti parenteralnim dozama atropina ili izoprenalina.
English: • Do not initiate siponimod treatment in patients with macular oedema until resolution.
Croatian: • Nemojte započeti liječenje siponimodom u bolesnika s makularnim edemom dok se ne povuče.
English: Hazard ratio: 0.74, p=0.0058; (95% Cl: 0.60, 0.92); risk reduction: 26%
Croatian: Omjer hazarda: 0,74, p=0,0058; (95% Cl: 0,60; 0,92); smanjenje rizika: 26%
English: Bradyarrhythmia
Croatian: Bradiaritmija
English: Hazard ratio: 0.69 (95% Cl: 0.53, 0.91); risk reduction: 31%
Croatian: Omjer hazarda: 0,69 (95% Cl: 0,53; 0,91); smanjenje rizika: 31%
English: • If a titration dose is missed on one day during the first 6 days of treatment, treatment must be re-initiated with a new titration pack.
Croatian: • Ako se propusti titracijska doza jednog od prvih 6 dana liječenja, liječenje se mora ponovo započeti s novim pakiranjem za titraciju.
English: Steady state was reached after approximately 6 days of multiple once-daily administration of siponimod.
Croatian: Stanje dinamičke ravnoteže bilo je dosegnuto nakon ponavljane primjene siponimoda tijekom otprilike 6 dana jedanput na dan.
English: • Pregnancy Reminder Card for women of childbearing potential.
Croatian: • Karticu s podsjetnikom o trudnoći za žene reproduktivne dobi.
English: Number of Mayzent 0.25 mg tablets to take
Croatian: Broj tableta Mayzenta od 0,25 mg koje treba uzeti