FrancophonIA/ELRC3.0 huggingface dataset:
English: 78% of patients had been previously treated with a therapy for their MS.
Slovenian: 78 % bolnikov je že prej prejemalo zdravila zaradi multiple skleroze.
English: In rare cases, the test result may indicate that you should not take Mayzent.
Slovenian: V redkih primerih lahko izvid te preiskave pokaže, da ne smete prejemati zdravila Mayzent.
English: Prior to launch of Mayzent in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Slovenian: Pred prihodom zdravila Mayzent na trg se mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi drugimi vidiki programa.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi bili lahko noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: These tumour findings were either regarded as mouse-specific or attributable to metabolic liver adaptations in the particularly sensitive rat species and are of questionable human relevance.
Slovenian: Te ugotovitve glede tumorjev so bodisi opredeljene kot specifične za miši ali pa jih je mogoče pripisati metabolni adaptaciji jeter pri posebno občutljivi vrsti podgan, njihov pomen za človeka pa je vprašljiv.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Slovenian: V okviru posameznega organskega sistema so neželeni učinki navedeni po pogostnosti, pri čemer so najpogostejši navedeni najprej.
English: • high blood pressure (hypertension), sometimes with symptoms such as headache and dizziness
Slovenian: • visok krvni tlak (hipertenzija), v nekaterih primerih skupaj s simptomi, kot sta glavobol in omotičnost
English: Do not use this medicine after the expiry date which is stated on the carton/blister foil after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli oziroma foliji pretisnega omota poleg oznake “EXP”.
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.
Slovenian: Če je izvid testa negativen, je priporočeno cepljenje, zdravljenje s siponimodom pa je treba odložiti za 1 mesec, da lahko cepljenje začne učinkovati v celoti.
English: There is no specific antidote to siponimod available.
Slovenian: Specifičnega antidota za siponimod ni.
English: Before the start of treatment your blood will also be tested to check how well your liver is working.
Slovenian: Pred začetkom zdravljenja bodo s krvno preiskavo ugotavljali tudi, kako dobro delujejo vaša jetra.
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).
Slovenian: Pri kroničnem zdravljenju se to zmanjšanje ni odrazilo s pojavljanjem klinično pomembnih neželenih dogodkov in ni bilo povezano s povečanjem obsega poročil o kašlju ali dispneji (glejte poglavje 5.1).
English: • Doctors will provide counselling in the event of pregnancy and evaluation of the outcome of any pregnancy.
Slovenian: • V primeru nosečnosti bodo zdravniki bolnicam zagotovili ustrezno svetovanje in vrednotenje izida katerekoli nosečnosti.
English: It is unknown whether siponimod or its major metabolites are excreted in human milk.
Slovenian: Ni znano, ali se siponimod ali njegovi poglavitni presnovki izločajo v materino mleko.
English: If you miss a dose when you are on the regular treatment dose (day 7 onwards), take it as soon as you remember.
Slovenian: Če pozabite vzeti odmerek, ko jemljete običajne odmerke (od 7. dne dalje), vzemite pozabljeni odmerek takoj, ko se spomnite.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA42
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA42
English: In monkeys, effects on muscle and skin were additionally observed.
Slovenian: Pri opicah so poleg tega opažali učinke na mišice in kožo.
English: - Hypersensitivity to the active substance, or to peanut, soya or any of the excipients listed in section 6.1.
Slovenian: - Preobčutljivost na učinkovino, arašide, sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Your doctor may decide not to prescribe Mayzent because it could intensify the effect on irregular heartbeat.
Slovenian: Zdravnik se bo morda odločil, da vam ne bo predpisal zdravila Mayzent, ker bi lahko okrepilo učinek na nepravilen srčni ritem.
English: In embryofoetal development studies conducted in rats and rabbits, siponimod induced embryotoxic effects in the absence of maternal toxicity.
Slovenian: V študijah embriofetalnega razvoja pri podganah in kuncih je siponimod induciral embriotoksične učinke brez toksičnih učinkov na mater.
English: • if you think your MS is getting worse or if you notice any new or unusual symptoms.
Slovenian: • če se opažate poslabšanje multiple skleroze ali nove ali neobičajne simptome.
English: Reduction of the peripheral blood lymphocytes
Slovenian: Znižanje števila limfocitov v periferni krvi
English: The MAH shall ensure that in each Member State (MS) where Mayzent is marketed, all physicians who intend to prescribe Mayzent are provided with an updated Physician Education Pack, including:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer je zdravilo Mayzent na trgu, vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Mayzent, prejeli posodobljen paket izobraževalnih gradiv za zdravnike, ki bo vseboval:
English: These may be symptoms of a type of meningitis caused by a fungal infection (cryptococcal meningitis).
Slovenian: Lahko gre za simptome vrste meningitisa, ki ga povzroča glivična okužba (kriptokokni meningitis).
English: • Due to the potential teratogenic risk of siponimod women of childbearing potential should:
Slovenian: • Zaradi možnega tveganja za teratogeno delovanje siponimoda za ženske v rodni dobi velja:
English: There is no experience with Mayzent in elderly patients.
Slovenian: Z uporabo zdravila Mayzent pri starejših bolnikih ni na voljo nobenih izkušenj.
English: If anything indicates that you may be at higher risk of suffering from these effects, your doctor may decide to monitor you more closely at the start of treatment, refer you first to a heart specialist (cardiologist), or choose not to give you Mayzent.
Slovenian: Če bi karkoli kazalo, da imate povečano tveganje za razvoj teh težav, se vaš zdravnik lahko odloči, da vas bo na začetku zdravljenja bolj skrbno spremljal, vas pred zdravljenjem napoti k specialistu za srce (kardiologu), ali pa se odloči, da vam zdravila Mayzent ne bo predpisal.
English: Mayzent may pass into breast milk and there is a risk of serious side effects for the baby.
Slovenian: Zdravilo Mayzent lahko prehaja v materino mleko in obstaja tveganje za resne neželene učinke pri otroku.
English: • Potential long-term safety implications in CYP2C9 poor metabolisers:
Slovenian: • Možne dolgoročne posledice pri slabih presnavljalcih encima CYP2C9:
English: Your doctor may want you to have an eye examination 3 or 4 months after starting treatment and possibly again later.
Slovenian: Zdravnik vam bo verjetno naročil, da opravite očesni pregled 3 ali 4 mesece po začetku zdravljenja in kasneje ponovno.
English: • After stopping treatment with Mayzent, patients should inform their doctor immediately if their disease symptoms are getting worse (e.g. weakness or visual changes) or if they notice any new symptoms.
Slovenian: • Po prekinitvi zdravljenja z zdravilom Mayzent morajo bolniki takoj obvestiti zdravnika, če se simptomi njihove bolezni slabšajo (če na primer opažajo šibkost ali spremembe vida) ali če opazijo pojav novih simptomov.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravnik vam bo povedal ali vam vaša bolezen dopušča varno vožnjo in uporabo strojev.
English: Other medicines and Mayzent
Slovenian: Druga zdravila in zdravilo Mayzent
English: Siponimod can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
Slovenian: Zdravljenje s siponimodom je načeloma mogoče začeti takoj po prekinitvi zdravljenja z interferonom beta oziroma z glatiramerjevim acetatom.
English: • What Mayzent is and how it works.
Slovenian: • Pojasnilo, kaj je zdravilo Mayzent in kako deluje.
English: The effect of siponimod on human fertility has not been evaluated.
Slovenian: Vpliva siponimoda na plodnost pri ljudeh niso ovrednotili.
English: You will be given a titration pack, with which your dose will be gradually increased over 5 days.
Slovenian: Prejeli boste titracijsko pakiranje, s pomočjo katerega boste v poteku 5 dni postopoma zviševali odmerek.
English: The purpose of the titration phase is to reduce the risk of side effects on your heart at the start of treatment.
Slovenian: Titracijska faza zdravljenja je namenjena zmanjševanju tveganja za neželene učinke na srce na začetku zdravljenja.
English: • regularly applying sunscreen with a high degree of UV protection.
Slovenian: • redno nanašate sredstvo z visokim faktorjem zaščite pred UV svetlobo.
English: Slow heart rate (bradycardia) and irregular heartbeat During the first days of treatment, Mayzent can cause the heart rate to slow down (bradycardia).
Slovenian: Počasno bitje srca (bradikardija) in nepravilno bitje srca Prvi dan zdravljenja lahko zdravilo Mayzent povzroči, da se bitje srca upočasni (bradikardija).
English: Change in cognitive processing speed on Symbol Digit Modality Test score was an exploratory endpoint.
Slovenian: Sprememba ocene hitrosti kognitivnega procesiranja pri izvajanju testa kodiranja (Symbol Digit Modalities Test, SDMT) je bila eksploratorni cilj opazovanja.
English: Mayzent is used to treat adults with secondary progressive multiple sclerosis (SPMS) with active disease.
Slovenian: Zdravilo Mayzent uporabljamo za zdravljenje odraslih s sekundarno progresivno multiplo sklerozo (SPMS), ki imajo aktivno bolezen.
English: The atrioventricular conduction delays manifested in most of the cases as first-degree atrioventricular (AV) blocks (prolonged PR interval on electrocardiogram).
Slovenian: Upočasnitev atrioventrikularnega prevajanja se je v večini primerov pokazala kot atrioventrikularni (AV) blok prve stopnje (podaljšanje intervala PR na elektrokardiogramu).
English: UV therapy during Mayzent treatment may increase your risk of developing skin cancer.
Slovenian: Zdravljenje z UV žarki v času zdravljenja z zdravilom Mayzent lahko poveča tveganje za razvoj kožnega raka.
English: Estimated CL/F (L/h)
Slovenian: pogostnost pri belcih ocenjen CL/F (l/h)
English: Anti-arrhythmic medicinal products, QT-prolonging medicinal products, medicinal products that may decrease heart rate
Slovenian: Antiaritmiki, zdravila, ki podaljšujejo interval QT, zdravila, ki lahko znižajo srčno frekvenco
English: Gender Results from population pharmacokinetics suggest that gender-based dose adjustment is not necessary.
Slovenian: Rezultati populacijske farmakokinetične analize kažejo, da prilagajanje odmerjanja na osnovi spola ni potrebno.
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).
Slovenian: V času zdravljenja z zdravilom Mayzent in do 4 tedne po zaključku zdravljenja z njim ne smete prejeti določenih vrst cepiv (ki jih imenujemo živa atenuirana cepiva), ker bi lahko sprožila okužbe, ki bi jih sicer morala preprečiti (glejte poglavje 2).
English: In the phase III clinical study, 1% of all discontinuations met one of these criteria.
Slovenian: V klinični študiji faze III bil eden od obeh navedenih pogojev izpolnjen pri 1 % vseh prekinitev zdravljenja.
English: • Titration pack as wallet containing 12 tablets, and
Slovenian: • titracijsko pakiranje v obliki zloženke, ki vsebuje 12 tablet, in
English: • Mayzent is contraindicated in:
Slovenian: • Zdravilo Mayzent je kontraindicirano pri:
English: Treatment with siponimod should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
Slovenian: Zdravljenje s siponimodom mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
English: Before you start treatment, your doctor will explain the risk and ask you to do a pregnancy test to ensure that you are not pregnant.
Slovenian: Preden začnete z zdravljenjem, vam bo zdravnik pojasnil, za kakšno tveganje gre, in vam naročil, da opravite test nosečnosti, s katerim se boste prepričali, da niste noseči.
English: Siponimod is distributed to body tissues with a moderate mean volume of distribution of 124 litres.
Slovenian: Siponimod se porazdeli po tkivih v telesu s srednje velikim povprečnim volumnom porazdelitve 124 litrov.
English: What you need to know before you take Mayzent
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Mayzent
English: A very rare brain infection called progressive multifocal leukoencephalopathy (PML) can cause symptoms similar to SPMS.
Slovenian: Zelo redka možganska okužba, ki jo imenujemo progresivna multifokalna levkoencefalopatija (PML), lahko povzroča podobne simptome kot sekundarno progresivna multipla skleroza.
English: • involuntary shaking of the body (tremor)
Slovenian: • nehoteno tresenje telesa (tremor)
English: Siponimod and its metabolites are excreted in the milk of rats.
Slovenian: Siponimod in njegovi presnovki se izločajo v mleko pri podganah.
English: Use of immunosuppressants within this period may lead to an additive effect on the immune system and therefore caution should be exercised for 3 to 4 weeks after the last dose.
Slovenian: Pri uporabi imunosupresivov v tem obdobju lahko pride do aditivnega učinka na imunski sistem, zato je previdnost potrebna še 3 do 4 tedne po prejemu zadnjega odmerka.
English: It can occur in patients taking medicines like Mayzent and other medicines used for treating MS.
Slovenian: Pojavi se lahko pri bolnikih, ki jemljejo zdravila, kot je Mayzent, ali druga zdravila za zdravljenje multiple skleroze.
English: The immune system effects of siponimod may increase the risk of infections (see section 4.8).
Slovenian: Zaradi učinkov siponimoda na imunski sistem lahko pride do povečanega tveganja za okužbe (glejte poglavje 4.8).
English: • Pack containing 120 tablets
Slovenian: • pakiranje, ki vsebuje 120 tablet.
English: Concomitant use of these substances during treatment initiation may be associated with severe bradycardia and heart block.
Slovenian: V času uvajanja zdravljenja je sočasna uporaba teh učinkovin lahko povezana s hudo bradikardijo in srčnim blokom.
English: • Irregular heartbeat (atrioventricular block)
Slovenian: • nereden srčni utrip (atrioventrikularni blok)
English: Initiation of treatment may result in decreased heart rate and indirect prolongation of the QT interval during the titration phase.
Slovenian: Uvajanje zdravljenja lahko povzroči znižanje srčne frekvence in posredno podaljšanje intervala QT v fazi titracije odmerka.
English: The risk of recurrence after re-challenge has not been evaluated.
Slovenian: Tveganja za ponovitev bolezni po ponovni uvedbi zdravila niso ovrednotili.
English: Clinical studies included patients up to the age of 61 years.
Slovenian: V klinične študije so bili vključeni bolniki, ki so bili stari do 61 let.
English: • if you could become pregnant, because siponimod can harm the unborn baby when used during pregnancy.
Slovenian: • če bi lahko zanosili, saj siponimod lahko škoduje nerojenemu otroku, če ga ženska uporablja v času nosečnosti.
English: • lung function test results showing decreased function
Slovenian: • izvidi preiskav pljučne funkcije, ki kažejo na zmanjšano funkcijo
English: Regular measurements of pulse rate and blood pressure are required and electrocardiograms should be performed (see sections 4.2 and 4.4).
Slovenian: Bolniku je treba redno meriti frekvenco pulza in krvni tlak ter pridobivati elektrokardiograme (glejte poglavji 4.2 in 4.4).
English: One patient (with a history of depression) who took 84 mg siponimod experienced a slight elevation in liver transaminases.
Slovenian: Pri enem bolniku (z anamnezo depresije), ki je vzel 84 mg siponimoda, je prišlo do rahlega zvišanja vrednosti jetrnih aminotransferaz.
English: Siponimod should be stopped at least 10 days before a pregnancy is planned (see section 4.4).
Slovenian: Z jemanjem siponimoda je treba prenehati najmanj 10 dni pred načrtovanjem nosečnosti (glejte poglavje 4.4).
English: In the vast majority (90%) of SPMS patients, lymphocyte counts return to the normal range within 10 days of stopping therapy.
Slovenian: Pri veliki večini (90 %) bolnikov s sekundarno progresivno multiplo sklerozo se število limfocitov vrne v okvir normalnih vrednosti v 10 dneh po prekinitvi zdravljenja.
English: • if you have an infection.
Slovenian: • če prebolevate okužbo.
English: In clinical studies treatment was discontinued if the elevation exceeded a 3-fold increase and the patient showed symptoms related to hepatic function or if the elevation exceeded a 5-fold increase.
Slovenian: V kliničnih študijah so jemanje siponimoda prekinili, če je bilo zvišanje več kot 3-kratno in so se pri bolniku pojavili simptomi, povezani z delovanjem jeter, ali če je bilo zvišanje več kot 5-kratno.
English: Bradycardia Atrioventricular block (first and second degree)
Slovenian: Srčne bolezni pogosti bradikardija atrioventrikularni blok (prve in druge stopnje)
English: In the extension part of the phase III clinical study, a case of cryptococcal meningitis (CM) has been reported (see section 4.4).
Slovenian: V podaljšanju klinične študije faze III so poročali o primeru kriptokoknega meningitisa (glejte poglavje 4.4).
English: Patients should be observed for relevant signs of possible severe exacerbation or return of high disease activity upon siponimod discontinuation and appropriate treatment should be instituted as required.
Slovenian: Bolnike je treba opazovati glede znakov, ki bi lahko pomenili, da gre za hudo poslabšanje ali ponovitev visoke aktivnosti bolezni po prekinitvi uporabe siponimoda in po potrebi uvesti ustrezno zdravljenje.
English: If you forget to take Mayzent
Slovenian: Če ste pozabili vzeti zdravilo Mayzent
English: The test identifies two variant alleles for CYP2C9: CYP2C9*2 (rs1799853, c.430C>T) and CYP2C9*3 (rs1057910, c.1075A>C).
Slovenian: S testom je mogoče prepoznati dva različna alela za encim CYP2C9: CYP2C9*2 (rs1799853, c.430C>T) in CYP2C9*3 (rs1057910, c.1075A>C).
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.
Slovenian: Po prejemu prvega titracijskega odmerka se začne srčna frekvenca zniževati v eni uri in prvi dan je njeno znižanje največje po približno 3 do 4 urah.
English: A core pharmacodynamic effect of siponimod is a dose-dependent reduction of the peripheral lymphocyte count to 20-30% of baseline values.
Slovenian: Bistven farmakodinamičen učinek siponimoda je od odmerka odvisno znižanje števila perifernih limfocitov na 20-30 % izhodiščne vrednosti.
English: Advise women of potential serious risks to the foetus if siponimod is used during pregnancy or if the patient becomes pregnant while taking it.
Slovenian: Ženske opozorite na možna resna tveganja za plod, če siponimod uporabljajo v času nosečnosti ali če zanosijo v času zdravljenja.
English: Siponimod absorption is extensive (≥70%, based on the amount of radioactivity excreted in urine and the amount of metabolites in faeces extrapolated to infinity).
Slovenian: Siponimod se obsežno absorbira (v ≥70 %, na osnovi v neskončnost ekstrapoliranih podatkov o količini radioaktivno označene učinkovine, ki se izloči z urinom, in o količini metabolitov v blatu).
English: Patients were randomised 2:1 to receive either once-daily siponimod 2 mg or placebo.
Slovenian: Bolniki so bili v razmerju 2:1 randomizirani tako, da so enkrat na dan prejemali bodisi siponimod 2 mg ali placebo.
English: In vitro investigations indicated that siponimod and its major systemic metabolites M3 and M17 do not show any clinically relevant drug-drug interaction potential at the therapeutic dose of 2 mg once daily for all investigated CYP enzymes and transporters, and do not necessitate clinical investigation.
Slovenian: Rezultati raziskav in vitro kažejo, da siponimod in njegova poglavitna sistemska presnovka M3 in M17 pri odmerjanju terapevtskega odmerka 2 mg enkrat na dan ne kažejo potenciala za klinično pomembno medsebojno delovanje z drugimi zdravili za nobenega od encimov CYP in prenašalcev, ki so jih raziskovali, tako da klinično raziskovanje pri tem ni potrebno.
English: Contains lactose and soya lecithin.
Slovenian: Vsebuje laktozo in sojin lecitin.
English: During the first 6 days of treatment initiation the recommended daily dose should be taken once daily in the morning with or without food.
Slovenian: V prvih 6 dneh uvajanja zdravljenja je priporočeni dnevni odmerek treba vzeti enkrat na dan, in sicer zjutraj, skupaj s hrano ali brez nje.
English: If any of the above applies to you, tell your doctor before taking Mayzent.
Slovenian: Če karkoli od navedenega velja za vas, povejte zdravniku, preden začnete jemati zdravilo Mayzent.
English: In clinical studies, second-degree AV blocks, usually Mobitz type I (Wenckebach), have been observed in less than 1.7% of patients at the time of treatment initiation.
Slovenian: V kliničnih študijah so AV blok druge stopnje, običajno tipa Mobitz I, (Wenckebachova periodika) v času uvajanja zdravila opažali pri manj kot 1,7 % bolnikov.
English: Siponimod was not studied in patients with significant QT prolongation (QTc >500 msec) or who were treated with QT-prolonging medicinal products.
Slovenian: Uporabe siponimoda niso proučevali pri bolnikih, ki so imeli pomembno podaljšanje intervala QT (QTc >500 msec) ali so prejemali zdravila, ki podaljšujejo interval QT.
English: • Patients should inform their doctor straight away if there is worsening of multiple sclerosis after stopping treatment with siponimod.
Slovenian: • Bolnice morajo takoj obvestiti zdravnika, če pride do poslabšanja multiple skleroze po prekinitvi zdravljenja s siponimodom.
English: This is due to the reversible sequestration of lymphocytes in lymphoid tissues (see section 5.1).
Slovenian: Do tega pride zaradi reverzibilne sekvestracije limfocitov v limfatičnem tkivu (glejte poglavje 5.1).
English: If you have taken too many Mayzent tablets, or if you take your first tablet from the treatment dose pack instead of the titration pack by mistake, call your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Mayzent kot bi smeli Če ste vzeli preveč tablet zdravila Mayzent ali če ste pomotoma vzeli prvo tableto iz pakiranja za redno zdravljenje namesto iz titracijskega pakiranja, takoj pokličite zdravnika.
English: Median age was 47 years, median disease duration was 15 years and median EDSS score at baseline was 6.0.
Slovenian: Mediana starosti je bila 47 let, mediana trajanja bolezni je bilo 15 let in mediana ocene EDSS ob izhodišču je bila 6,0.
English: The possibility of severe exacerbation of disease after stopping siponimod treatment should be considered.
Slovenian: Upoštevati je treba možnost hudega poslabšanja bolezni po prekinitvi zdravljenja s siponimodom.