FrancophonIA/ELRC3.0 huggingface dataset:
English: Four studies compared the effects of Galvus, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
Slovenian: V štirih študijah so primerjali učinke zdravila Galvus v odmerku 50 ali 100 mg na dan v obdobju 24 tednov z učinki placeba, kadar je bilo uporabljeno kot dodatek k obstoječemu zdravljenju z metforminom (544 bolnikov), pioglitazonom (tiazolidindionom, 463 bolnikov), glimepiridom (sulfonilsečnino, 515 bolnikov) ali insulinom (296 bolnikov).
English: Why has Galvus been approved?
Slovenian: Zakaj je bilo zdravilo Galvus odobreno?
English: The CHMP noted that Galvus was effective as an add-on to metformin, a thiazolidinedione or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin, and concluded that the benefits of the add-on treatment outweigh the risks.
Slovenian: CHMP je ugotovil, da je bilo zdravilo Galvus učinkovito kot dodatek zdravljenju z metforminom, tiazolidindionom ali sulfonilsečnino (zdravljenje z dvema zdraviloma), kot dodatek sulfonilsečnini in metforminu (zdravljenje s tremi zdravili) ali insulinu z metforminom ali brez njega, ter zaključil, da so koristi dodatnega zdravljenja večje od tveganj.
English: Galvus is used to treat type 2 diabetes mellitus.
Slovenian: Zdravilo Galvus se uporablja za zdravljenje sladkorne bolezni tipa 2.
English: In the study involving 296 patients taking insulin, adding Galvus caused a greater reduction in HbA1c levels than adding placebo, but the size of this effect was small possibly due to the fact that the study included long-term patients who were less likely to show improvement..
Slovenian: V študiji, v kateri je sodelovalo 296 bolnikov, ki so jemali insulin, je dodajanje zdravila Galvus povzročilo večje znižanje ravni HbA1c kot dodajanje placeba, vendar je bila razlika zelo majhna, kar je verjetno posledica dejstva, da je študija vključevala dolgotrajne bolnike, pri katerih je bilo izboljšanje stanja manj verjetno.
English: In the study comparing Galvus with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Galvus.
Slovenian: V študiji, v kateri so zdravilo Galvus primerjali z metforminom, so bili opaženi občutno boljši rezultati z metforminom: znižanje HbA1c za 1,5 odstotne točke po 52 tednih v primerjavi z znižanjem za okoli 1 odstotno točko pri bolnikih, ki so prejemali zdravilo Galvus.
English: When used as an add-on to existing treatment for type 2 diabetes, Galvus was more effective than placebo in reducing HbA1c levels.
Slovenian: Pri njegovi uporabi kot dodatna terapija k obstoječemu zdravljenju sladkorne bolezni tipa 2 je bilo zdravilo Galvus pri zniževanju koncentracije HbA1c učinkovitejše od placeba.
English: Galvus used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines.
Slovenian: Kadar se je zdravilo Galvus uporabljalo samostojno, je bilo sicer učinkovito pri zniževanju ravni HbA1c, a manj kot primerjalna zdravila.
English: In combination with metformin and glimepiride, 50 mg Galvus taken twice a day reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.
Slovenian: V kombinaciji z metforminom in glimepiridom je zdravilo Galvus v odmerku 50 mg dvakrat na dan znižalo ravni HbA1c za eno odstotno točko v primerjavi z znižanjem za 0,3 odstotne točke pri bolnikih, ki so jemali placebo.
English: Patients taking Galvus in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.
Slovenian: Pri bolnikih, ki so zdravilo Galvus jemali kot dodatek insulinu z metforminom ali brez njega, se je raven HbA1c znižala za 0,77 odstotne točke, medtem ko se je pri bolnikih, ki so kot dodatek insulinu jemali placebo, znižala le za 0,05 odstotne točke.
English: Five of these studies looked at the effects of Galvus taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea).
Slovenian: V petih študijah so pri skupno 3 644 bolnikih proučevali učinke zdravila Galvus, uporabljenega samostojno, ter jih primerjali z učinki placeba (zdravila brez zdravilne učinkovine), metformina, rosiglitazona (tiazolidindiona) ali gliklazida (sulfonilsečnine).
English: What is Galvus used for?
Slovenian: Za kaj se zdravilo Galvus uporablja?
English: How does Galvus work?
Slovenian: Kako zdravilo Galvus deluje?
English: What is Galvus?
Slovenian: Kaj je zdravilo Galvus?
English: How has Galvus been studied?
Slovenian: Kako je bilo zdravilo Galvus raziskano?
English: How is Galvus used?
Slovenian: Kako se zdravilo Galvus uporablja?
English: A further study compared Galvus with placebo as an add-on treatment in 318 patients who were already taking metformin and glimepiride.
Slovenian: V nadaljnji študiji so pri 318 bolnikih, ki so že jemali metformin ali glimepirid, zdravilo Galvus primerjali s placebom, če je bilo uporabljeno kot dodatek zdravljenju.
English: A further study compared Galvus with placebo as an add-on treatment in 449 patients who were already taking a stable dose of long-acting insulin.
Slovenian: V nadaljnji študiji so pri 449 bolnikih, ki so že jemali ustaljen odmerek insulina z dolgotrajnim delovanjem, zdravilo Galvus primerjali s placebom, kadar sta bila uporabljena kot dodatek zdravljenju.
English: • wearing appropriate protective clothing.
Slovenian: • nosite ustrezna zaščitna oblačila,
English: You may not feel anything or you may feel dizzy or tired.
Slovenian: Morda ne boste čutili ničesar, lahko pa boste postali omotični ali utrujeni.
English: • pain in hands or feet
Slovenian: • bolečine v rokah in stopalih
English: Tests before and during treatment
Slovenian: Preiskave pred in med zdravljenjem
English: Your doctor may decide to keep you under observation.
Slovenian: Zdravnik se bo morda odločil, da vas zadrži na opazovanju.
English: The safety and efficacy of siponimod in children and adolescents aged 0 to 18 years have not yet been established.
Slovenian: Varnost in učinkovitost siponimoda pri otrocih in mladostnikih, starih 0 do 18 let, še nista bili dokazani.
English: Ask your doctor about reliable methods of contraception.
Slovenian: Z zdravnikom se pogovorite o zanesljivih metodah kontracepcije.
English: Siponimod is taken with or without food.
Slovenian: Siponimod se jemlje skupaj s hrano ali brez nje.
English: Study month
Slovenian: meseci v študiji
English: Mayzent is taken once daily.
Slovenian: Zdravilo Mayzent se jemlje enkrat na dan.
English: These could be serious and possibly even life-threatening.
Slovenian: Te okužbe so lahko resne in v nekaterih primerih celo življenjsko nevarne.
English: Take tablet(s) at the same time every day.
Slovenian: Tablete jemljite vsak dan ob istem času.
English: • if you have severe breathing problems when sleeping (sleep apnoea).
Slovenian: • če imate hude težave z dihanjem med spanjem (apnejo v spanju).
English: Unexpected neurological or psychiatric symptoms/signs
Slovenian: Nepričakovani nevrološki ali psihiatrični simptomi/znaki
English: Race/Ethnicity
Slovenian: Rasa/etnična pripadnost
English: In both species, prenatal mortality was increased.
Slovenian: Pri obeh vrstah je prišlo do povečane prenatalne umrljivosti.
English: Your doctor will advise you on this if this is relevant for you.
Slovenian: Glede tega vam bo svetoval vaš zdravnik, če je to za vas pomembno.
English: At least overnight extended monitoring is recommended.
Slovenian: Priporoča se podaljšano spremljanje najmanj preko noči.
English: Do not give this medicine to children and adolescents below 18 years of age because it has not yet been studied in this age group.
Slovenian: Tega zdravila se ne sme dajati otrokom in mladostnikom, ki so stari manj kot 18 let, saj uporaba zdravila v tej starostni skupini še ni bila proučena.
English: Your doctor will advise you on this.
Slovenian: Glede tega vam bo svetoval vaš zdravnik.
English: • Periodic safety update reports (PSURs) The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Missed dose after day 6
Slovenian: Izpuščeni odmerek po 6. dnevu
English: Both are single nucleotide polymorphisms.
Slovenian: V obeh primerih gre za enojni nukleotidni polimorfizem.
English: Take the tablet with water.
Slovenian: Tableto zaužijte z vodo.
English: Follow the instructions on the pack (see also the “Titration pack” table).
Slovenian: Upoštevajte navodila, ki so označena na pakiranju (glejte tudi preglednico “Titracijsko pakiranje”).
English: • The importance of reporting adverse reactions.
Slovenian: • Pomen poročanja o neželenih učinkih.
English: • if you have ever had liver problems.
Slovenian: • če ste imeli kadarkoli težave z jetri.
English: Elderly patients (65 years of age and above)
Slovenian: Starostniki (stari 65 let ali več)
English: • What multiple sclerosis is.
Slovenian: • Pojasnilo, kaj je multipla skleroza.
English: You will have to restart at day 1.
Slovenian: Ponovno boste morali začeti z odmerkom za 1. dan.
English: Risk of infections
Slovenian: Tveganje za okužbe
English: Post-dose declines on the following days are less pronounced.
Slovenian: Zmanjšanje frekvence po odmerjanju je v naslednjih dneh manj izraženo.
English: Women of childbearing potential/Contraception in females
Slovenian: Ženske v rodni dobi / kontracepcija pri ženskah
English: If you are allergic to peanut or soya, do not use this medicine.
Slovenian: Če ste alergični na arašide ali sojo, ne smete jemati tega zdravila.
English: On day 6, you will switch to your regular treatment dose.
Slovenian: 6. dan boste prešli na jemanje ustreznega običajnega odmerka za zdravljenje.
English: Mayzent will stay in your body for up to 10 days after you stop taking it.
Slovenian: Zdravilo Mayzent bo ostalo v vašem telesu še 10 dni po tem, ko ga boste prenehali jemati.
English: Additional exposure of 0.25 mg on day 5 does not compromise patient safety.
Slovenian: Dodatna izpostavljenost zaradi za 0,25 mg večjega odmerka na 5. dan ne ogroža bolnikove varnosti.
English: Study duration was variable for individual patients (median study duration was 21 months, range: 1 day to 37 months).
Slovenian: Trajanje študije je bila spremenljivka pri posameznem bolniku (mediano trajanje študije je bilo 21 mesecev, od 1 dan do 37 mesecev).
English: Siponimod has no or negligible influence on the ability to drive and use machines.
Slovenian: Siponimod nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In these patients, it is recommended that an electrocardiogram (ECG) is obtained prior to dosing and at the end of the observation period.
Slovenian: Pri teh bolnikih se priporoča posneti elektrokardiogram (EKG) pred odmerjanjem in na koncu obdobja opazovanja.
English: How quickly this medicine is broken down (metabolised) in the body varies from patient to patient and different people therefore require different doses.
Slovenian: Od bolnika do bolnika se razlikuje, kako hitro se to zdravilo v telesu razgrajuje (presnavlja), zato različni ljudje potrebujejo različne odmerke.
English: If this applies to you, note that it is nevertheless safe for you to take five 0.25 mg tablets on day 5 of the titration period as indicated above.
Slovenian: Če se to pokaže pri vas, morate vedeti, da je kljub temu varno, če v titracijskem obdobju na 5. dan vzamete pet 0,25-miligramskih tablet, kot je navedeno zgoraj.
English: The absolute oral bioavailability of siponimod is approximately 84%.
Slovenian: Absolutna peroralna biološka uporabnost siponimoda je približno 84 %.
English: The majority of cases occurred within the first 3-4 months of therapy.
Slovenian: Do večine primerov je prišlo v prvih 3-4 mesecih zdravljenja.
English: • Patient/Caregiver Guide to be provided to all patients;
Slovenian: • vodnik za bolnike/skrbnike, ki ga morajo prejeti vsi bolniki;
English: Patients who experienced bradycardia were generally asymptomatic.
Slovenian: Bolniki, pri katerih je prišlo do bradikardije, so bili večinoma asimptomatski.
English: For further clarifications please refer to your local laboratory.
Slovenian: Prosimo, da se za dodatna pojasnila obrnete na lokalni labolatorij.
English: Make sure to tell your doctor if you are taking or receiving any of the following medicines or therapies:
Slovenian: Zdravniku morate povedati, če jemljete ali uporabljate katero od naslednjih zdravil ali terapij:
English: The apparent elimination half-life of siponimod is approximately 30 hours.
Slovenian: Navidezni razpolovni čas izločanja siponimoda je približno 30 ur.
English: The film-coated tablets should be swallowed whole with water.
Slovenian: Filmsko obložene tablete je treba zaužiti cele, skupaj z vodo.
English: Potential to prolong the QT interval
Slovenian: Zmožnost podaljševanja intervala QT
English: Total and unbound AUCs were only slightly increased (by 23 to 33%) compared to healthy subjects.
Slovenian: AUC celokupnega in nevezanega siponimoda sta bili nekoliko (za 23 do 33 %) večji kot pri zdravih osebah.
English: • Women exposed to siponimod during pregnancy are encouraged to join the pregnancy exposure programme (PRegnancy outcomes Intensive Monitoring, PRIM) that monitors outcomes of pregnancy.
Slovenian: • Ženske, ki so v času nosečnosti izpostavljene siponimodu, se spodbuja, da se vključijo v program izpostavljenosti v nosečnosti (program intenzivnega spremljanja izidov nosečnosti, PRegnancy outcomes Intensive Monitoring programme - PRIM), ki je namenjen spremljanju izidov nosečnosti.
English: The most common adverse drug reactions are headache (15%) and hypertension (12.6%).
Slovenian: Najpogostejša neželena učinka sta glavobol (15 %) in hipertenzija (12,6 %).
English: On your first day of treatment with Mayzent, therefore, you should not drive or use machines.
Slovenian: Zato prvi dan zdravljenja z zdravilom Mayzent ne smete voziti in upravljati strojev.
English: On the first 6 days of treatment, it is recommended that you take the tablets in the morning with or without food.
Slovenian: Za prvih 6 dni zdravljenja je priporočljivo, da tablete vzamete zjutraj skupaj s hrano ali brez nje.
English: • Other reminders:
Slovenian: • Druga opozorila:
English: - Active malignancies.
Slovenian: - Aktivna maligna bolezen.
English: Your chance of developing macular oedema is higher if you have had it before or if you have ever had uveitis (an inflammation of the eye).
Slovenian: Možnost, da se pri vas razvije makularni edem, je večja, če ste ga imeli že kdaj prej ali če ste že kdaj imeli uveitis (vnetje očesa).
English: Such events have not been reported for siponimod in the development programme.
Slovenian: V razvojnem programu siponimoda niso poročali o nobenem takem dogodku.
English: • Bradyarrhythmia (including conduction defects) during treatment initiation:
Slovenian: • Bradiaritmija (vključno z motnjami prevajanja) v času uvajanja zdravljenja:
English: Specific measures are also included in the Physician Education Pack.
Slovenian: Posebni ukrepi so opisani tudi v Kontrolnem seznamu za zdravnika.
English: Your doctor may instruct you to take only 1 mg once daily (four 0.25 mg tablets) if the blood test performed before the start of treatment showed that your body breaks down Mayzent slowly (see “Tests before and during treatment”).
Slovenian: Zdravnik vam bo morda naročil, da morate jemati samo 1 mg enkrat na dan (štiri 0,25-miligramske tablete), če bodo krvne preiskave, ki jih boste opravili pred začetkom zdravljenja, pokazale, da se zdravilo Mayzent v vašem telesu razgrajuje počasi (glejte “Preiskave pred in med zdravljenjem”).
English: The effect persisted with continued treatment.
Slovenian: Z nadaljevanjem zdravljenja se je ta učinek ohranjal.
English: • Summary of Product Characteristics;
Slovenian: • povzetek glavnih značilnosti zdravila;
English: Mayzent lowers the number of white cells in your blood.
Slovenian: Zdravilo Mayzent znižuje število belih krvnih celic v krvi.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Pri tem ustrezna kategorija pogostnosti posameznega neželenega učinka temelji na naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
English: Neither dialysis nor plasma exchange would result in meaningful removal of siponimod from the body.
Slovenian: Niti dializa niti izmenjava plazme ne omogočata odstranitve pomembne količine siponimoda iz telesa.
English: • if you have an infection or if your immune system does not work properly (for example due to a disease or to medicines that suppress the immune system; see also “Other medicines and Mayzent”).
Slovenian: • če imate okužbo ali vaš imunski sistem ne deluje ustrezno (na primer zaradi bolezni ali zdravil, ki zavirajo delovanje imunskega sistema; glejte tudi pod naslovom “Druga zdravila in zdravilo Mayzent”).
English: The effects of therapeutic (2 mg) and supratherapeutic (10 mg) doses of siponimod on cardiac repolarisation were investigated in a thorough QT study.
Slovenian: Učinek terapevtskih (2 mg) in supraterapevtskih (10 mg) odmerkov siponimoda na repolarizacijo srca so proučevali v podrobni študiji intervala QT.
English: Other side effects include those listed below.
Slovenian: Drugi možni neželeni učinki vključujejo spodaj navedene težave.
English: (Primary endpoint)
Slovenian: (primarni cilj opazovanja)
English: The pharmacological activity of the main metabolites M3 and M17 is not expected to contribute to the clinical effect and the safety of siponimod in humans.
Slovenian: Farmakološka aktivnost poglavitnih dveh metabolitov M3 in M17 predvidoma ne prispeva h kliničnim učinkom in varnosti uporabe siponimoda pri ljudeh.
English: • swollen hands, ankles, legs or feet (peripheral oedema)
Slovenian: • otekline rok, gležnjev, nog ali stopal (periferni edemi)
English: • blood test results showing increased liver enzyme levels
Slovenian: • izvidi krvnih preiskav, ki kažejo zvišane vrednosti jetrnih encimov
English: Potential of other medicinal products to affect siponimod pharmacokinetics
Slovenian: Potencial drugih zdravil za vplivanje na farmakokinetiko siponimoda
English: Siponimod had no effect on male reproductive organs in rats and monkeys or on fertility parameters in rats.
Slovenian: Siponimod ni vplival na moške reproduktivne organe pri podganah in opicah ali na parametre plodnosti pri podganah.
English: Your doctor may ask you to stop taking these to avoid an increased effect on the immune system.
Slovenian: Zdravnik vam bo morda naročil, da ta zdravila prenehate jemati, da ne bi prišlo do okrepljenega delovanja na imunski sistem.
English: Due to the high plasma protein binding (>99.9%) of siponimod, haemodialysis is not expected to alter the total and unbound siponimod concentration and no dose adjustments are anticipated based on these considerations.
Slovenian: Zaradi obsežne vezave siponimoda na proteine v plazmi (>99,9 %) hemodializa predvidoma ne vpliva na koncentracije celokupnega in nevezanega siponimoda in na osnovi navedenega prilagajanje odmerkov ni predvideno.
English: Siponimod should not be used during breast-feeding.
Slovenian: Siponimoda se med dojenjem ne sme uporabljati.
English: Siponimod did not exert any phototoxic or dependence potential and was not genotoxic in vitro and in vivo.
Slovenian: Siponimod ni izkazoval fototoksičnega potenciala ali potenciala za razvoj odvisnosti in ni bil genotoksičen niti in vitro niti in vivo.
English: Your doctor will need to prescribe a new titration pack.
Slovenian: Zdravnik vam bo moral predpisati novo titracijsko pakiranje.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with siponimod in one or more subsets of the paediatric population in the treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s siponimodom za eno ali več podskupin pediatrične populacije za zdravljenje multiple skleroze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Treatment dose The recommended dose is 2 mg once daily (one tablet of 2 mg Mayzent) with or without food.
Slovenian: Priporočeni odmerek je 2 mg enkrat na dan (ena 2-miligramska tableta zdravila Mayzent) skupaj s hrano ali brez nje.
English: The conduction abnormalities typically were transient, asymptomatic, resolved within 24 hours and did not require discontinuation of treatment.
Slovenian: Prevodne motnje so bile običajno prehodne in asimptomatske, izzvenele so v 24 urah in zaradi njih ni bilo treba prekinjati zdravljenja.
English: • Novartis has put in place a PRegnancy outcomes Intensive Monitoring (PRIM) programme, which is a registry based on enhanced follow-up mechanisms to collect information about pregnancy in patients exposed to siponimod immediately before or during pregnancy and on infant outcomes 12 months post-delivery.
Slovenian: • Družba Novartis je vzpostavila program intenzivnega spremljanja izidov nosečnosti (PRegnancy outcomes Intensive Monitoring (PRIM) programme), ki predstavlja register na osnovi mehanizmov okrepljenega spremljanja za pridobivanje podatkov o nosečnostih pri bolnicah, ki so bile izpostavljene siponimodu tik pred zanositvijo ali v času nosečnosti, in o izidih pri dojenčkih v 12 mesecih po rojstvu.
English: • Mayzent is not recommended in:
Slovenian: • Zdravilo Mayzent ni priporočeno pri:
English: • Macular oedema:
Slovenian: • Makularni edem:
English: • Infections, including varicella zoster reactivation, reactivation of the other viral infections, PML and other rare opportunistic infections:
Slovenian: • Okužbe, vključno z reaktivacijo okužbe z virusom varicella zoster, reaktivacijo drugih virusnih okužb, progresivno multifokalno levkoencefalopatijo (PML) in drugimi redkimi oportunističnimi okužbami:
English: Clinical evaluations were performed at screening and every 3 months and at the time of relapse.
Slovenian: Klinično vrednotenje so izvajali pri presejalnem postopku (screening), nato pa vsake 3 mesece in v času zagona.
English: Despite a delay in Tmax to 8 hours after a single dose, food intake had no effect on the systemic exposure of siponimod (Cmax and AUC), therefore siponimod may be taken without regard to meals (see section 4.2).
Slovenian: Kljub podaljšanju tmax po prejemu enkratnega odmerka na 8 ur uživanje hrane ni vplivalo na sistemsko izpostavljenost siponimodu (Cmax in AUC), zato se lahko siponimod jemlje ne glede na uživanje hrane (glejte poglavje 4.2).
English: The majority of elevations occurred within 6 months of starting treatment.
Slovenian: Do zvišanih vrednosti je večinoma prišlo v 6 mesecih po začetku zdravljenja.
English: • Siponimod should be stopped at least 10 days before a pregnancy is planned.
Slovenian: • Z jemanjem siponimoda je treba prenehati najmanj 10 dni pred načrtovanjem nosečnosti.
English: After siponimod therapy has been stopped, siponimod remains in the blood for up to 10 days.
Slovenian: Po prekinitvi zdravljenja s siponimodom ostane siponimod v krvi še do 10 dni.