FrancophonIA/ELRC3.0 huggingface dataset:
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells)
Slovenian: YESCARTA 0,4-2 x 108 celic disperzija za infundiranje aksicabtagen ciloleucel (CAR+ viabilne T-celice)
English: Thirty-two percent (32%) of patients experienced Grade 3 or higher (severe or life-threatening) adverse reactions.
Slovenian: Nevrološki neželeni učinki so se pojavili pri 67 % bolnikov, pri čemer je 32 % bolnikov imelo neželene učinke 3. ali višje stopnje (hude ali smrtno nevarne).
English: Evaluation for haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) should be considered in patients with severe or unresponsive CRS.
Slovenian: Pri bolnikih s hudim ali neodzivnim CRS je treba pomisliti na sindrom hemofagocitne limfohistiocitoze/aktivacije makrofagov (HLH/MAS, haemophagocytic lymphohistiocytosis/macrophage activation syndrome).
English: Prophylactic anti-microbials should be administered according to standard institutional guidelines.
Slovenian: V skladu s standardnimi smernicami ustanove je treba profilaktično dajati protimikrobna snovi učinkovine.
English: It is not known if YESCARTA has the potential to be transferred to the foetus.
Slovenian: Ni znano, ali se lahko zdravilo YESCARTA prenaša na plod.
English: Grade 1
Slovenian: 1. stopnja
English: Eleven percent (11%) of patients experienced Grade 3 or higher (severe, life-threatening, and fatal) CRS.
Slovenian: CRS se je pojavil pri 93 % bolnikov, pri čemer je bil CRS pri 11 % bolnikov 3. ali višje stopnje (huda oblika, smrtno nevaren in smrten).
English: NE (0.4, 29.5)
Slovenian: NO (0,4, 17,3) NO (0,4, 29,5) NO (0,4, 17,3) NO (0,4, 29,5)
English: HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells.
Slovenian: Pri bolnikih, zdravljenih z zdravili, usmerjenimi proti B-celicam, se lahko pojavi reaktivacija HBV, ki v nekaterih primerih povzroči fulminantni hepatitis, odpoved jeter in smrt.
English: Consider alternate immunosuppressants if no improvement or if condition worsens.
Slovenian: Če ni izboljšanja ali se stanje poslabša, razmislite o drugem imunosupresivu.
English: Fatal and serious cases of cerebral oedema have been reported in patients treated with YESCARTA.
Slovenian: Pri bolnikih, zdravljenih z zdravilom YESCARTA, so poročali o smrtnih in resnih primerih možganskega edema.
English: There is no experience of use of YESCARTA in patients with primary CNS lymphoma.
Slovenian: Primarni limfom osrednjega živčnega sistema (OŽS) Izkušenj z uporabo zdravila YESCARTA pri bolnikih s primarnim limfomom OŽS ni.
English: Per Grade 2
Slovenian: Kot 2. stopnja
English: Respiratory, thoracic and mediastinal disorders Very common
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti kašelj dispneja hipoksija plevralni izliv
English: Thrombosis Capillary leak syndrome
Slovenian: Pogosti tromboza sindrom kapilarne krvavitve
English: • Verify that the patient's identity (ID) matches the patient identifiers on the YESCARTA cassette.
Slovenian: • Potrdite, da se identiteta (ID) bolnika ujema z identifikacijskimi oznakami bolnika na kaseti zdravila YESCARTA.
English: Store frozen in vapour phase of liquid nitrogen ≤ -150˚C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte zamrznjeno v parni fazi tekočega dušika ≤ -150 °C.
English: Adverse reactions Dyscalculia Myoclonus
Slovenian: Pogosti ataksija nevropatija epileptični napadi diskalkulija mioklonus
English: After you are given YESCARTA
Slovenian: Po tem, ko prejmete zdravilo YESCARTA
English: YESCARTA must not be irradiated.
Slovenian: Zdravila YESCARTA ni dovoljeno obsevati.
English: After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Slovenian: Po prvih 10 dneh po infundiranju je treba bolnika spremljati po presoji zdravnika.
English: Serious adverse reactions including encephalopathy (22%), aphasia (4%), delirium (4%), and seizures (1%) have been reported in patients administered YESCARTA.
Slovenian: Pri bolnikih, ki so dobili zdravilo YESCARTA, so poročali o resnih neželenih učinkih, vključno z encefalopatijo (22 %), afazijo (4 %), delirijem (4 %) in epileptičnimi napadi (1 %).
English: After the first 10 days following infusion, the patient should be monitored at the physician's discretion.
Slovenian: Po prvih 10 dnevih od infundiranja je treba bolnike spremljati po presoji zdravnika.
English: Vomiting Constipation Abdominal pain Dry mouth
Slovenian: Zelo pogosti driska navzea bruhanje zaprtje bolečine v trebuhu suha usta
English: Treatment algorithms have been developed to ameliorate the neurologic adverse reactions experienced by patients on YESCARTA.
Slovenian: Za lajšanje nevroloških neželenih učinkov, ki se pojavljajo pri bolnikih, zdravljenih z zdravilom YESCARTA, so bili razviti algoritmi zdravljenja.
English: CRS Grade (a)
Slovenian: Preglednica 1: Stopnje CRS in navodila za obravnavo Stopnja CRS (a)
English: Male gender Race White Asian Black ECOG status ECOG 0 ECOG 1 Median number of prior therapies (min, max)
Slovenian: ECOG 0 ECOG 1 Mediano število predhodnih zdravljenj (min, maks) Bolniki z boleznijo, neodzivno na ≥ 2 predhodni vrsti zdravljenj
English: YESCARTA bags must be stored in the vapour phase of liquid nitrogen (≤ -150 ˚C) and YESCARTA must remain frozen until the patient is ready for treatment to ensure viable live autologous cells are administered to the patient.
Slovenian: YESCARTA mora ostati zamrznjeno, dokler ni bolnik pripravljen na zdravljenje, da se zagotovi dajanje viabilnih avtolognih celic bolniku.
English: • A lymphodepleting chemotherapy regimen consisting of cyclophosphamide 500 mg/m2 intravenous and fludarabine 30 mg/m2 intravenous should be administered on the 5th, 4th, and 3rd day before infusion of YESCARTA.
Slovenian: • Na 5., 4. in 3. dan pred infundiranjem zdravila YESCARTA mora bolnik prejeti režim kemoterapije za uničenje limfocitov, sestavljen iz ciklofosfamida 500 mg/m2 intravensko in fludarabina 30 mg/m2intravensko.
English: - Inflammation and swelling of spinal cord which may cause partial or total paralysis of limbs and torso.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) vnetje in oteklina hrbtenjače, ki lahko povzročita delno ali popolno paralizo okončin in trupa
English: B-cell aplasia leading to hypogammaglobulinaemia can occur in patients receiving treatment with YESCARTA.
Slovenian: Pri bolnikih, ki prejemajo zdravljenje z zdravilom YESCARTA, se lahko pojavi B-celična aplazija, ki vodi v hipogamaglobulinemijo.
English: YESCARTA must be administered in a qualified clinical setting.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravilo YESCARTA se mora dajati v usposobljenem kliničnem okolju.
English: • Verify the patient ID again to match the patient identifiers on the YESCARTA bag.
Slovenian: • Ponovno potrdite ujemanje identitete bolnika z identifikacijskimi informacijami o bolniku na vreči zdravila YESCARTA.
English: Cytokine release syndrome
Slovenian: Sindrom sproščanja citokinov
English: • After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Slovenian: • Po 10 dneh od infundiranja je treba bolnika spremljati po presoji zdravnika.
English: The following side effects have been reported with YESCARTA.
Slovenian: Pri zdravilu YESCARTA so poročali o naslednjih neželenih učinkih:
English: Non-sedating, anti-seizure medicines should be considered as clinically indicated for Grade 2 or higher adverse reactions.
Slovenian: Pri neželenih reakcijah 2. stopnje ali več je treba razmisliti o nesedativnih zdravilih proti epileptičnim napadom.
English: Kite Pharma EU B.V. Science Park 406
Slovenian: Science Park 406
English: HCP Educational program
Slovenian: Izobraževalni program za zdravstvene delavce
English: Adverse drug reactions identified with YESCARTA
Slovenian: Preglednica 3: Neželeni učinki, ugotovljeni pri zdravilu YESCARTA
English: Concurrent CRS
Slovenian: Ocena stopnje Sočasen CRS
English: Dizziness Aphasia
Slovenian: Dolgotrajne citopenije
English: In particular, you must not be given certain vaccines called live vaccines:
Slovenian: Še zlasti ne smete biti cepljeni z nekaterimi cepivi, ki se imenujejo živa cepiva: • 6 tednov pred kratkim režimom kemoterapije (imenovane kemoterapija za uničenje limfocitov),
English: • Once thawed, YESCARTA is stable at room temperature (20 °C-25 °C) for up to 3 hours.
Slovenian: • Odtajano zdravilo YESCARTA je do 3 ure stabilno pri sobni temperaturi (20 °C-25 °C).
English: Treatment algorithms have been developed to ameliorate some of the CRS symptoms experienced by patients on YESCARTA.
Slovenian: Za lajšanje nekaterih simptomov CRS, ki se pojavljajo pri bolnikih, zdravljenih z zdravilom
English: Each patient-specific single infusion bag contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg.
Slovenian: Ena infuzijska vreča za enkratno uporabo, specifična za bolnika, vsebuje disperzijo anti-CD19 CAR T-celic v približno 68 ml za ciljni odmerek 2 x 106
English: YESCARTA 0.4 - 2 x 108 cells dispersion for infusion axicabtagene ciloleucel (CAR+ viable T cells) For intravenous use only.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE YESCARTA 0,4-2 x 108 celic disperzija za infundiranje aksicabtagen ciloleucel (CAR+ viabilne T-celice) Samo za intravensko uporabo.
English: Encephalopathy Headache Tremor
Slovenian: Zelo pogosti encefalopatija glavobol tremor omotica afazija
English: lightheadedness, fluid in the lungs, which may be severe and can be fatal (all symptoms of a condition called cytokine release syndrome).
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) zvišana telesna temperatura, mrzlica, zmanjšan krvni tlak, ki lahko povzroči simptome, kot so omotica, vrtoglavica, tekočina v pljučih, ki so lahko resni ali smrtni (vsi simptomi stanja, ki se imenuje sindrom sproščanja citokinov)
English: • Inspect the product bag for any breaches of container integrity before thawing.
Slovenian: • Pred odtajanjem preglejte, ali je okrnjena celovitost vsebnika vreče z zdravilom.
English: Cardiac arrest Cardiac failure
Slovenian: Pogosti zastoj srca srčno popuščanje
English: Kite Pharma EU B.V. Science Park 408
Slovenian: Science Park 408
English: How you are given YESCARTA
Slovenian: Kako boste zdravilo prejeli YESCARTA
English: NE (0.0, 29.5)
Slovenian: 14,0 (0,0, 17,3) NO (0,0, 29,5) 14,0 (0,0, 17,3) NO (0,0, 29,5)
English: Patients should be monitored at least daily for 10 days at the qualified healthcare facility following infusion for signs and symptoms of neurologic toxicity.
Slovenian: Bolnike je treba prvih 10 dni po infundiranju vsaj dnevno spremljati glede znakov in simptomov nevrološke toksičnosti v usposobljeni klinični ustanovi.
English: Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis.
Slovenian: Za profilakso pred epileptičnimi napadi je treba razmisliti o nesedativnih zdravilih proti epileptičnim napadom (npr. levetiracetam).
English: Leukopenia Neutropenia Anaemia
Slovenian: Zelo pogosti levkopenija nevtropenija anemija trombocitopenija
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Obsevanje bi lahko povzročilo inaktivacijo zdravila.
English: Talk to your doctor if you need to have any vaccinations.
Slovenian: Če se morate cepiti s katerim koli cepivom, se posvetujte z zdravnikom.
English: - Fluid in the lungs.
Slovenian: Pogosti pljučni edem
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Ena sterilna vreča za infundiranje.
English: How YESCARTA is given
Slovenian: Kako se daje zdravilo YESCARTA
English: Tachycardia Arrhythmia
Slovenian: Zelo pogosti tahikardija aritmija
English: Grading assessment
Slovenian: POSTOPEK UPORABE
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: n/s = navedba ni smiselna/potrebna
English: The pregnancy status of women of child bearing potential must be verified before starting YESCARTA treatment.
Slovenian: Pred uvedbo zdravljenja z zdravilom YESCARTA je treba pri ženskah v rodni dobi opraviti test nosečnosti.
English: Discuss pregnancy with your doctor if you have received YESCARTA.
Slovenian: Če ste dobili zdravilo YESCARTA, se o nosečnosti pogovorite z zdravnikom.
English: Clinical efficacy and safety DLBCL, PMBCL and DLBCL arising from follicular lymphoma (ZUMA-1)
Slovenian: DLBCL, PMBCL in DLBCL zaradi folikularnega limfoma (ZUMA-1) Z zdravilom YESCARTA je bilo skupaj zdravljenih 108 bolnikov v odprti, multicentrični študiji
English: Medicines given before YESCARTA treatment
Slovenian: Po prejemu zdravila YESCARTA
English: The availability of YESCARTA must be confirmed prior to starting the lymphodepleting regimen.
Slovenian: Pred začetkom režima za uničenja limfocitov (limfocitna deplecija) je treba potrditi, da je zdravilo
English: How to store YESCARTA
Slovenian: Shranjevanje zdravila YESCARTA
English: Local biosafety guidelines should be followed for unused medicine or waste material.
Slovenian: Pri ravnanju z neuporabljenim zdravilom ali odpadnim materialom je treba upoštevati lokalne smernice za zagotavljanje biološke varnosti.
English: Bilirubin increased
Slovenian: Pogosti povišana raven bilirubina
English: Dispersion for infusion
Slovenian: Drugi viri informacij
English: - Signs and symptoms of blood clots.
Slovenian: Spremljati je treba pojav znakov in simptomov
English: - Lung infection.
Slovenian: Pogosti glivične okužbe
English: Ninety-eight percent (98%) of patients recovered from CRS.
Slovenian: Osemindevetdeset odstotkov (98 %)
English: - Extreme tiredness.
Slovenian: Zelo pogosti delirij tesnoba
English: A total of 108 patients were treated with YESCARTA in a phase 1/2 open-label, multicentre, singlearm study in patients with relapsed or refractory aggressive B-cell NHL.
Slovenian: faze z enim krakom pri bolnikih s ponovljenim ali neodzivnim, agresivnim B-celičnim NHL.
English: General disorders and administration site conditions Very common
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: • The YESCARTA product bag must not be removed from the cassette if the information on the patient-specific label does not match the intended patient.
Slovenian: • Če se podatki na nalepki, specifični za bolnika, ne ujemajo s podatki bolnika, ki mu je zdravilo namenjeno, vreče zdravila YESCARTA ni dovoljeno vzeti iz kasete.
English: OTHER
Slovenian: Črna
English: Diarrhoea Nausea
Slovenian: Bolezni živčevja
English: Hypersensitivity Histiocytosis Haematophagic
Slovenian: Pogosti preobčutljivost hematofagična histiocitoza
English: Further information on Mayzent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Mayzent.
Slovenian: Nadaljnje informacije za zdravilo Mayzent so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Mayzent.
English: The maintenance dose is either 1 mg or 2 mg daily, depending on how quickly the patient's body can process the medicine.
Slovenian: Vzdrževalni odmerek je 1 mg ali 2 mg na dan, odvisno od tega, kako hitro lahko bolnikovo telo predela zdravilo.
English: What measures are being taken to ensure the safe and effective use of Mayzent?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mayzent?
English: The dose is then progressively increased to reach the ‘maintenance' dose on the sixth day.
Slovenian: Odmerek se nato postopno povečuje, da se šesti dan doseže „vzdrževalni“ odmerek.
English: Mayzent is available as tablets and should be taken once a day.
Slovenian: Zdravilo Mayzent je na voljo v obliki tablet in ga je treba jemati enkrat dnevno.
English: This is determined by the use of a blood or saliva test to measure the activity of the patient's liver enzyme CYP2C9.
Slovenian: To se določi s pomočjo testa krvi ali sline za merjenje dejavnosti bolnikovega jetrnega encima CYP2C9.
English: Other information about Mayzent
Slovenian: Druge informacije o zdravilu Mayzent
English: The Agency therefore decided that Mayzent's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zato zaključila, da so koristi zdravila Mayzent večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Treatment is started with a dose of 0.25 mg daily for two days.
Slovenian: Zdravljenje se začne z odmerkom 0,25 mg enkrat na dan prva dva dni.
English: As for all medicines, data on the use of Mayzent are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Mayzent stalno spremljajo.
English: The medicine must also not be used in patients who previously had certain severe infections (known as progressive multifocal leukoencephalopathy or cryptococcal meningitis).
Slovenian: Zdravilo se prav tako ne sme uporabljati pri bolnikih, ki so pred tem že imeli določene hude okužbe (znane kot progresivna multifokalna levkoencefalopatija ali kriptokokni meningitis).
English: It must not be used in patients who have recently had a stroke and in patients with certain heart disorders (because of its effects on heart rate and blood pressure), severe liver disorders and in pregnant women and women who can become pregnant and are not using effective contraception.
Slovenian: Ne sme se uporabljati pri bolnikih, ki so pred kratkim doživeli možgansko kap, ter bolnikih z nekaterimi boleznimi srca (zaradi učinkov zdravila na srčni utrip in krvni tlak) in hudimi obolenji jeter ter nosečnicah in ženskah, ki lahko zanosijo in ne uporabljajo učinkovite kontracepcije.
English: It is used in patients with active disease, which means that patients still have relapses or signs of inflammation can be seen in scans.
Slovenian: Uporablja se pri bolnikih z aktivno boleznijo, kar pomeni, da imajo bolniki še vedno zagone ali da so znaki vnetja vidni na slikovnih posnetkih.
English: What benefits of Mayzent have been shown in studies?
Slovenian: Kakšne koristi zdravila Mayzent so se pokazale v študijah?
English: Why is Mayzent authorised in the EU?
Slovenian: Zakaj je zdravilo Mayzent odobreno v EU?
English: Mayzent must also not be used in patients who have inherited a gene known as CYP2C9*3 from both parents, which makes them unable to process the medicine fast enough.
Slovenian: Zdravilo Mayzent se prav tako ne sme uporabljati pri bolnikih, ki so podedovali gen, znan pod imenom CYP2C9 * 3, od obeh staršev, zaradi česar zdravila ne morejo predelati dovolj hitro.
English: The most common side effects with Mayzent (which may affect more than 1 in 10 people) are headache and hypertension (high blood pressure).
Slovenian: Najpogostejša neželena učinka zdravila Mayzent (ki se lahko pojavita pri več kot 1 bolniku od 10) sta glavobol in hipertenzija (povišan krvni tlak).
English: The European Medicines Agency therefore decided that Mayzent should only be used in patients whose disease is active with signs of inflammation.
Slovenian: Evropska agencija za zdravila je zato sklenila, da se lahko zdravilo Mayzent uporablja le pri bolnikih, pri katerih je bolezen aktivna z znaki vnetja.
English: An overview of Mayzent and why it is authorised in the EU
Slovenian: Pregled zdravila Mayzent in zakaj je odobreno v EU
English: What are the risks associated with Mayzent?
Slovenian: Kakšna tveganja so povezana z zdravilom Mayzent?
English: Mayzent must also not be used in patients with cancer and certain immune disorders due to its effect on the immune system.
Slovenian: Zdravilo Mayzent se tudi ne sme uporabljati pri bolnikih z rakom in določenimi imunskimi motnjami zaradi njegovega vpliva na imunski sistem.
English: What is Mayzent and what is it used for?
Slovenian: Kaj je zdravilo Mayzent in za kaj se uporablja?
English: Mayzent was shown to be effective at delaying the progression of the disease in a 3-year main study involving 1,651 patients with secondary progressive MS, of whom 779 had active disease with a relapse within 2 years or other signs of inflammation in scans.
Slovenian: Zdravilo Mayzent se je izkazalo za učinkovito pri upočasnitvi napredovanja bolezni v triletni glavni študiji, v katero je bilo vključenih 1 651 bolnikov s sekundarno progresivno multiplo sklerozo, od katerih jih je 779 imelo aktivno bolezen z zagonom v dveh letih ali druge znake vnetja na slikovnih posnetkih.
English: Side effects reported with Mayzent are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Mayzent, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The materials will include a guide for patients with key safety information about Mayzent, as well as a pregnancy reminder card for women who can become pregnant.
Slovenian: Gradivo bo vsebovalo navodila za bolnike s ključnimi varnostnimi informacijami o zdravilu Mayzent, pa tudi opozorilno kartico glede nosečnosti za ženske, ki bi lahko zanosile.
English: For more information about using Mayzent, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Mayzent glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mayzent have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Mayzent upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Disease progression was defined as worsening of the disease that is independent from a relapse and is maintained over at least 3 months, as assessed using a standard scale called EDSS.
Slovenian: Napredovanje bolezni je bilo opredeljeno kot poslabšanje bolezni, ki je neodvisno od zagona in traja vsaj tri mesece, kot je bilo ocenjeno na podlagi standardne lestvice, imenovane EDSS (razširjena lestvica statusa invalidnosti).
English: The company that markets Mayzent will ensure that doctors expected to prescribe the medicine receive educational materials, including a checklist covering the necessary screening, pre-treatment and longterm monitoring of patients.
Slovenian: Podjetje, ki trži zdravilo Mayzent, bo za zdravnike, ki naj bi predpisovali zdravilo, zagotovilo izobraževalno gradivo, vključno s kontrolnim seznamom, ki bo zajemal potrebne presejalne preglede, predhodno zdravljenje in dolgotrajno spremljanje bolnikov.
English: The active substance in Mayzent, siponimod, blocks the action of some receptors (targets) on cells called sphingosine-1-phosphate receptors, which are involved in the movement of lymphocytes (immune cells) around the body.
Slovenian: Učinkovina v zdravilu Mayzent, siponimod, zavira delovanje nekaterih receptorjev (tarč) na celicah, imenovanih receptorji sfingozin-1-fosfata, ki sodelujejo pri gibanju limfocitov (imunskih celic) po telesu.
English: Mayzent must not be used in patients who are hypersensitive (allergic) to siponimod, or to peanut, soya or any of the other ingredients of the medicine.
Slovenian: Zdravilo Mayzent se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) siponimod, arašide, sojo ali katero koli drugo sestavino zdravila.
English: In MS, the immune system (the body's defences) attacks and damages the protective sheath around the nerves in the brain and spinal cord.
Slovenian: Pri multipli sklerozi imunski sistem (obrambni mehanizem telesa) napade in poškoduje zaščitno ovojnico, ki obdaja živce v možganih in hrbtenjači.
English: During the study, 25% of patients with active secondary progressive MS taking Mayzent had disease progression compared with 35% of patients taking placebo (a dummy treatment).
Slovenian: Med študijo je do napredovanja bolezni prišlo pri 25 % bolnikov z aktivno sekundarno progresivno multiplo sklerozo, ki so jemali zdravilo Mayzent, v primerjavi s 35 % bolnikov, ki so jemali placebo (zdravilo brez učinkovine).