FrancophonIA/ELRC3.0 huggingface dataset:
English: Ataluren is metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes, predominantly UGT1A9 in liver, intestine and kidney.
Slovenian: Ataluren se presnavlja s konjugacijo preko encimov uridin difosfat glukuronoziltransferaz (UGT), predvsem preko UGT1A9 v jetrih, črevesju in ledvicah.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Box
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla
English: Mannitol (E421)
Slovenian: makrogol poloksamer manitol (E421)
English: The safety profile of ataluren is based on pooled data from two randomised, double-blind, 48-week placebo-controlled studies conducted in a total of 232 male patients with Duchenne muscular dystrophy (nmDMD) caused by a nonsense mutation treated at the recommended dose of 40 mg/kg/day (10, 10, 20 mg/kg; n=172) or at a dose of 80 mg/kg/day (20, 20, 40 mg/kg; n=60), as compared to placebo-treated patients (n=172).
Slovenian: Varnostni profil za ataluren temelji na združenih podatkih iz dveh randomiziranih, dvojno slepih, 48tedenskih, s placebom kontroliranih študij, ki so jih izvajali pri skupno 232 moških bolnikih z Duchennovo mišično distrofijo, ki je bila posledica nesmiselne mutacije (nmDMD), zdravljenih s priporočenim odmerkom 40 mg/kg/dan (10, 10, 20 mg/kg; n = 172) ali z odmerkom 80 mg/kg/day (20, 20, 40 mg/kg; n = 60), v primerjavi z bolniki, ki so prejemali placebo (n = 172).
English: Ataluren plasma half-life ranges from 2-6 hours and is unaffected either by dose or repeated administration.
Slovenian: Plazemski razpolovni čas atalurena je od 2-6 ur, niti odmerek niti ponavljajoče se odmerjanje pa nanj ne vplivata.
English: Following multiple dosing, the increase in ataluren and ataluren metabolite is anticipated to be higher in patients with severe renal impairment and end-stage renal disease when compared with patients with normal renal function at steady state.
Slovenian: Po večkratnem odmerjanju je pričakovati, da bo povečanje atalurena in njegovega presnovka večje pri bolnikih s hudo okvaro ledvic in končno ledvično odpovedjo v primerjavi z bolniki z normalnim delovanjem ledvic v stanju dinamičnega ravnovesja.
English: In a clinical study to evaluate the potential for ataluren to inhibit the OATP1B3 transport system using a single-dose of 80 mg telmisartan, an in-vitro selective OATP1B3 substrate, ataluren increased the exposure to telmisartan by 28%.
Slovenian: V klinični študiji, v kateri so vrednotili potencial atalurena za zaviranje sistema za prenašanje OATP1B3 z enkratnim odmerkom 80 mg telmisartana, in-vitro selektivnega OATP1B3, je ataluren za
English: The other ingredients are: polydextrose (E1200), macrogol, poloxamer, mannitol (E421), crospovidone, hydroxyethyl cellulose, artificial vanilla flavour (maltodextrin, artificial flavours and propylene glycol), silica, colloidal anhydrous (E551), magnesium stearate.
Slovenian: Druge sestavine zdravila so: polidekstroza (E1200), makrogol, poloksamer, manitol (E421), krospovidon, hidroksietilceluloza, umetna vanilijeva aroma (maltodekstrin, umetne arome in propilenglikol), koloidni brezvodni silicijev dioksid (E551) in magnezijev stearat.
English: Patients with severe renal impairment (eGFR <30 ml/min) or end-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk (see sections 4.2 and 4.4).
Slovenian: Bolnike s hudo okvaro ledvic (eGFR < 30 ml/min) ali končno ledvično odpovedjo je treba z atalurenom zdraviti le, če pričakovane klinične koristi pretehtajo tveganje (glejte poglavji 4.2 in 4.4).
English: Discard the prepared dose if not taken within 24 hours of preparation if kept refrigerated (2 - 8 °C), or within 3 hours at room temperature (1530 °C).
Slovenian: Zavrzite pripravljen odmerek, v kolikor ga niste vzeli v 24 urah po pripravi, če je bil shranjen v hladilniku (2-8 °C), oziroma v 3 urah, če je bil shranjen pri sobni temperaturi (15-30 °C).
English: Pack of 30 sachets.
Slovenian: Pakiranje, ki vsebuje 30 vrečic.
English: The serum creatinine elevations resolved in all cases, with discontinuation of the intravenous aminoglycoside, and either continuation or interruption of Translarna.
Slovenian: Zvišane ravni so se v vseh primerih popravile po prenehanju uporabe aminoglikozidov za intravensko uporabo, bodisi ob nadaljevanju ali prekinitvi zdravljenja z zdravilom Translarna.
English: Medicinal products that affect the p-glycoprotein transporter
Slovenian: Zdravila, ki vplivajo na prenašalec p-glikoprotein
English: Recommended dosing intervals are 6 hours between morning and midday doses, 6 hours between midday and evening doses, and 12 hours between the evening dose and the first dose on the next day.
Slovenian: Priporočeni presledek je 6 ur med jutranjim in popoldanskim odmerkom, 6 ur med popoldanskim in večernim odmerkom ter 12 ur med večernim odmerkom in prvim odmerkom naslednjega dne.
English: In the rat pre/postnatal developmental toxicity study, at exposure about 5 times human exposure, significant maternal toxicity as well as effects on offspring body weight and development of ambulatory activity were observed.
Slovenian: V študiji toksičnosti za prenatalni/postnatalni razvoj pri podganah so pri izpostavljenosti, ki je bila 5-krat večja od tiste pri človeku, opazili znatno toksičnost pri materi ter tudi vpliv na telesno maso mladičev ter razvoj sposobnosti hoje.
English: What you need to know before you take Translarna Do not take Translarna
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Translarna
English: A nonsense mutation in DNA results in a premature stop codon within an mRNA.
Slovenian: Nesmiselna mutacija v DNA povzroči, da se na mRNA prezgodaj pojavi zaključni kodon.
English: You may experience mild headache, nausea, vomiting or diarrhoea.
Slovenian: Lahko se pojavi blag glavobol, slabost, bruhanje ali driska.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ataluren in two subsets of the paediatric population from birth to less than 28 days and infants from 28 days to less than 6 months in nmDMD, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z atalurenom za dve podskupini pediatrične populacije, dojenčke od rojstva do starosti manj kot 28 dni ter otroke, stare od 28 dni do manj kot 6 mesecev, z nmDMD, pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Serum lipids
Slovenian: Serumski lipidi
English: Patients were randomised in a 1:1:1 ratio and received ataluren or placebo 3 times per day (morning, midday, and evening), with 57 receiving ataluren 40 mg/kg/day (10, 10, 20 mg/kg), 60 receiving ataluren 80 mg/kg/day (20, 20, 40 mg/kg), and 57 receiving placebo.
Slovenian: Bolniki so bili randomizirani v razmerju 1 : 1 : 1 in so 48 tednov prejemali ataluren ali placebo 3-krat na dan (zjutraj, popoldne in zvečer), pri čemer jih je 57 prejemalo ataluren 40 mg/kg/dan (10, 10 in 20 mg/kg), 60 ataluren 80 mg/kg/dan (20, 20 in 40 mg/kg), 57 pa jih je prejemalo placebo.
English: The significance for humans is not known.
Slovenian: Kakšen je pomen tega za ljudi, ni znano.
English: As the primary endpoint (change in 6MWD from baseline to Week 48) did not reach statistical significance (p≤0.05),
Slovenian: Ker primarni opazovani dogodek (sprememba v 6MWD od izhodišča do 48. tedna) ni dosegel statistične značilnosti (p ≤ 0,05), je treba vse druge vrednosti p- obravnavanti nominalno.
English: What Translarna looks like and contents of the pack
Slovenian: Izgled zdravila Translarna in vsebina pakiranja
English: Mean Change in Timed Function Tests (Study 2)
Slovenian: Povprečna sprememba v časovno merjenih funkcijskih testih (študija 2)
English: After a single oral dose of radiolabeled ataluren, approximately half of the administered radioactive dose is recovered in the faeces and the remainder was recovered in the urine.
Slovenian: Po dajanju enkratnega peroralnega odmerka radioaktivno označenega atalurena so približno polovico danega radioaktivnega odmerka odkrili v blatu, preostali del pa v urinu.
English: The steady-state is established after approximately two weeks of thrice daily dosing.
Slovenian: Stanje dinamičnega ravnovesja se vzpostavi po približno dveh tednih odmerjanja trikrat na dan.
English: The adverse reactions reported in patients with nmDMD treated with the recommended daily dose of 40 mg/kg/day ataluren in the 2 placebo-controlled studies are presented in Table 1.
Slovenian: Neželeni učinki, o katerih so poročali pri bolnikih z nmDMD, ki so jih zdravili s priporočenim dnevnim odmerkom atalurena 40 mg/kg/dan, so predstavljeni v razpredelnici 1.
English: Your doctor must have done a blood test to confirm that your disease is suitable for treatment with Translarna.
Slovenian: Opozorila in previdnostni ukrepi Zdravnik mora najprej opraviti krvne preiskave, da ugotovi, ali je vaša bolezen primerna za zdravljenje z zdravilom Translarna.
English: Patients should not take a double or extra dose if a dose is missed.
Slovenian: Bolniki, ki so izpustili odmerek, ne smejo vzeti dvojnega ali dodatnega odmerka.
English: Mean Change in Timed Function Tests (Study 1)
Slovenian: Povprečna sprememba v časovno merjenih funkcijskih testih (študija 1)
English: You or your child will have been tested by your doctor before starting treatment with Translarna, in order to confirm that your disease is suitable for treatment with this medicine.
Slovenian: Pred začetkom zdravljenja z zdravilom Translarna bo zdravnik pri vas ali vašem otroku opravil preiskavo, s katero bo ugotovil, ali je bolezen primerna za zdravljenje s tem zdravilom.
English: Frequency not known (frequency cannot be estimated from the available data): - Increases in blood lipids - Increases in test for kidney function
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: In vitro, ataluren is not a substrate for the p-glycoprotein transporter.
Slovenian: In vitro ataluren ni substrat prenašalca p-glikoproteina.
English: The differences favoring ataluren versus placebo in mean changes in timed function tests at Week 48 in the ITT population reached the threshold for a clinically meaningful difference (changes ~1 to 1.5 seconds).
Slovenian: V časovno merjenih funkcijskih testih v 48. tednu so razlike pri populaciji ITT v povprečnih spremembah v korist atalurena v primerjavi s placebom ITT dosegle prag za klinično pomembno razliko (spremembe ~1 do 1,5 sekunde).
English: Nonclinical in vitro experiments in nonsense mutation cellular assays and fish larvae cultured in an ataluren solution have shown that ataluren enabled ribosomal readthroughwith a bell-shaped (inverted-U shaped) concentration-response relationship.
Slovenian: Predklinični poskusi in vitro v celičnih preskusih nesmiselne mutacije in pri ribjih mladicah, gojenih v raztopini atalurena, so pokazali, da je ataluren ribosomom omogočil podaljšanje translacij; povezava med koncentracijo in odzivom je bila v obliki zvona (narobe obrnjene črke U).
English: Co-administration of ataluren with mycophenolate mofetil in healthy subjects did not affect the exposure of its active metabolite, mycophenolic acid (a substrate of UGT1A9).
Slovenian: Sočasna uporaba atalurena z mofetilmikofenolatom pri zdravih prostovoljcih ni vplivala na izpostavljenost njegovemu aktivnemu presnovku, mikofenolni kislini (substrat UGT1A9).
English: Based on the urinary recovery of radioactivity in a single-dose study of radiolabeled ataluren, the oral bioavailability of ataluren is estimated to be ≥ 55%.
Slovenian: Glede na izmerjeno radioaktivnost v urinu v študiji enkratnega odmerka radioaktivno označenega atalurena je ocenjena biološka uporabnost atalurena ≥ 55-odstotna.
English: At a single, relatively low, maternal dose of 30 mg/kg radiolabelled ataluren, the highest measured concentration of radioactivity in rat milk was 37% of the maternal plasma concentration.
Slovenian: Po enkratnem relativno majhnem odmerku radioaktivno označenega atalurena 30 mg/kg, ki so ga dali materi, je najvišja izmerjena koncentracija radioaktivnosti v mleku pri podganah znašala 37 % plazemske koncentracije pri materi.
English: Administration of ataluren on a body weight-adjusted basis (mg/kg) resulted in similar steady-state exposures (AUC) among children and adolescents with nmDMD over a broad range of body weights.
Slovenian: Dajanje odmerkov atalurena, prilagojenih telesni masi (mg/kg), je pri otrocih in mladostnikih z nmDMD in zelo različnimi telesnimi masami povzročilo podobne izpostavljenosti (AUC) v stanju dinamičnega ravnovesja.
English: Weeks
Slovenian: Tedni
English: In addition, ataluren was found to increase nephrotoxicity of intravenous aminoglycosides.
Slovenian: Poleg tega je bilo ugotovljeno, da ataluren poveča nefrotoksičnost aminoglikozidov za intravensko uporabo.
English: Similarly, ataluren is not expected in vivo to be an inducer of cytochrome P450 isoenzymes.
Slovenian: Prav tako ni pričakovati, da bi ataluren in vivo induciral izoencime citokroma P450.
English: The effect of co-administration of ataluren with other nephrotoxic medicinal products is unknown.
Slovenian: Učinek sočasne uporabe atalurena in drugih nefrotoksičnih zdravil ni znan.
English: Other endpoints included in both trials were time to persistent 10% worsening in 6MWD, change in time to run/walk 10 meters at Week 48, change in time to climb 4 stairs at Week 48, and change in time to descend 4 stairs at Week 48.
Slovenian: so bili čas do trajnega 10-% poslabšanja 6MWD, sprememba v času prehojenih/pretečenih 10 metrov v 48. tednu, sprememba v času vzpenjanja po 4 stopnicah v 48. tednu in sprememba v času spuščanja po 4 stopnicah v 48. tednu.
English: Adverse reactions reported in >1 ataluren-treated patients with nmDMD at a frequency greater than placebo in the 2 placebo-controlled studies (pooled analysis)
Slovenian: Neželeni učinki, o katerih so poročali pri > 1 bolniku, zdravljenih z atalurenom, z nmDMD v 2 s placebom kontroliranih študijah (združena analiza).
English: Ataluren-treated patients experienced clinical benefit as measured by numerically favorable differences versus placebo across the primary and secondary efficacy endpoints.
Slovenian: Za bolnike, zdravljene z atalurenom, so ugotovili klinično korist za primarni in sekundarni opazovani dogodek učinkovitosti, izmerjeno kot numerično boljše razdalje v primerjavi s placebom.
English: Patients were required to have documented confirmation of the presence of a nonsense mutation in the dystrophin gene as determined by gene sequencing.
Slovenian: Prav tako so bolniki morali imeti potrdilo o prisotnosti nesmiselne mutacije gena za distrofin, ki je bila ugotovljena s sekvenciranjem genov.
English: Translarna is white to off-white granules for oral suspension in sachets.
Slovenian: Zdravilo Translarna je v obliki belih ali skoraj belih zrnc za peroralno suspenzijo v vrečicah.
English: Age-adjusted dosing is not required.
Slovenian: Prilagajanje odmerka glede na starost ni potrebno.
English: This premature stop codon in the mRNA causes disease by terminating translation before a full-length protein is generated.
Slovenian: Ta prezgodnji zaključni kodon na mRNA prekine translacijo, še preden nastane beljakovina s polno dolžino, in s tem povzroči bolezen.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ataluren in one subset of the paediatric population aged 6 months to less than 5 years old in nmDMD, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z atalurenom za eno podskupino pediatrične populacije in sicer otroke, stare od 6 mesecev do manj kot 5 let, z nmDMD, pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: How to take Translarna
Slovenian: Kako jemati zdravilo Translarna
English: Treatment of patients with severe renal impairment (eGFR <30 ml/min) or end-stage renal disease is not recommended (see sections 4.4 and 5.2).
Slovenian: Zdravljenje bolnikov s hudo okvaro ledvic (eGFR < 30 ml/min) ali končno odpovedjo ledvic ni priporočljivo (glejte poglavji 4.4 in 5.2).
English: The elimination of ataluren is likely dependent on hepatic and renal glucuronidation of ataluren followed by renal and hepatic excretion of the resulting glucuronide metabolite.
Slovenian: Izločanje atalurena je verjetno odvisno od glukuronidacije atalurena v jetrih in ledvicah, ki ji sledi izločitev nastalega glukuronidnega presnovka skozi ledvice in jetra.
English: Breast-feeding should be discontinued during treatment with ataluren.
Slovenian: Med zdravljenjem z atalurenom je treba prenehati z dojenjem.
English: These findings were seen in dogs at systemic exposure equivalent to 0.8 times the steady state AUC in patients administered Translarna at respective morning, midday, and evening doses of 40 mg/kg/day and higher.
Slovenian: Vse to so pri psih opazili pri sistemski izpostavljenosti, ki je bila enaka 0,8-kratni AUC v stanju dinamičnega ravnovesja pri bolnikih, ki so jemali jutranje, popoldanske in večerne odmerke zdravila Translarna 40 mg/kg/dan ali večje.
English: Your doctor will monitor your blood pressure every 6 months, if you are taking a corticosteroid medicine.
Slovenian: Če uporabljate zdravilo, ki vsebuje kortikosteroide, bo zdravnik vsakih 6 mesecev preveril vaš krvni tlak.
English: In order to confirm the efficacy and safety of ataluren in the treatment of ambulant patients with nmDMD aged 5 years or older, the MAH should conduct and submit the results of a multicentre, randomised, double-blind, 18-month, placebocontrolled study, followed by a 18-month open label extension, according to an agreed protocol.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za potrditev učinkovitosti in varnosti atalurena za zdravljenje bolnikov z Duchennovo mišično distrofijo kot posledico nesmiselne mutacije, ki so stari 5 let ali več in lahko hodijo, opraviti multicentrično, randomizirano, dvojno slepo 18-mesečno študijo, nadzorovano s placebom, ki ji bo sledilo 18-mesečno odprto podaljšanje, skladno s sprejetim protokolom, ter predložiti rezultate študije.
English: Evening mg sachets mg sachets mg sachets
Slovenian: Zvečer mg vrečice mg vrečice mg vrečice mg vrečice mg vrečice mg vrečice
English: Translarna is a medicine that contains the active substance ataluren.
Slovenian: Kaj je zdravilo Translarna in za kaj ga uporabljamo Translarna je zdravilo, ki vsebuje učinkovino ataluren.
English: Aminoglycosides have been shown to reduce the readthrough activity of ataluren in vitro.
Slovenian: Aminoglikozidi dokazano zmanjšajo učinek atalurena na podaljšanje translacije in vitro.
English: Evening
Slovenian: Popoldne
English: Renal function monitoring
Slovenian: Spremljanje delovanja ledvic
English: You may have one or more of the following side effects after taking Translarna:
Slovenian: Ko boste vzeli zdravilo Translarna, se lahko pri vas pojavi eden ali več neželenih učinkov, navedenih v nadaljevanju:
English: Caution should also be exercised when ataluren is co-administered with OAT3 substrates (eg, ciprofloxacin), especially those OAT3 substrates with a narrow therapeutic window.
Slovenian: Kadar se ataluren uporablja sočasno z zdravili, ki so substrati OAT3 (npr. ciprofloksacin), zlasti substrati OAT3 z majhno terapevtsko širino, je prav tako potrebna previdnost.
English: There should be 6 hours between morning and midday doses, 6 hours between midday and evening doses, and 12 hours between the evening dose and the first dose on the next day.
Slovenian: Presledek med jutranjim in popoldanskim odmerkom naj bo 6 ur, med popoldanskim in večernim odmerkom prav tako 6 ur, med večernim odmerkom in prvim odmerkom naslednjega dne pa 12 ur.
English: Heat-sealed laminated aluminium foil sachet: polyethylene terephthalate (child resistance), polyethylene (coloring and polyester/foil bond), aluminum foil (moisture barrier), adhesive (polyurethane class), copolymer of ethylene and methacrylic acid (sealant resin for packaging integrity).
Slovenian: Toplotno zavarjena vrečica iz laminirane aluminijaste folije: polietilen tereftalat (varnost za otroke), polietilen (obarvanost in vezava poliestra/folije), aluminijasta folija (zaščita pred vlago), lepilo (poliuretansko), kopolimer etilena in metakrilne kisline (tesnilna smola za neokrnjenost pakiranja).
English: If you become pregnant while taking Translarna, consult your doctor immediately as it is recommended not to take Translarna while you are pregnant or breast-feeding.
Slovenian: Če zanosite med jemanjem zdravila Translarna, se takoj posvetujte z zdravnikom, saj jemanje zdravila Translarna med nosečnostjo in dojenjem ni priporočljivo.
English: These findings suggested that co-administration of Translarna and intravenous aminoglycosides may potentiate the nephrotoxic effect of the aminoglycosides.
Slovenian: Te ugotovitve kažejo, da lahko sočasna uporaba zdravila Translarna in aminoglikozidov za intravensko uporabo okrepi nefrotoksični učinek aminoglikozidov.
English: Translarna should be administered orally after mixing it to a suspension in liquid or in semi-solid food.
Slovenian: Zdravilo Translarna je treba dati peroralno, potem ko se s tekočino ali redko hrano zmeša v suspenzijo.
English: Over 48 weeks, ataluren-treated patients showed less decline in muscle function, as evidenced by smaller increases in the time to run/walk 10 meters, climb 4 steps, and descend 4 steps in the atalurentreated group relative to placebo.
Slovenian: V 48 tednih je bil upad mišične funkcije pri bolnikih, zdravljenih z atalurenom, manjši, kar je bilo dokazano z manjšim povečanjem časa teka/hoje na 10 metrov, časa vzpenjanja po 4 stopnicah in časa spuščanja po 4 stopnicah v skupini, zdravljeni z atalurenom, v primerjavi s skupino, ki je prejemala placebo.
English: Non-clinical data revealed no hazard for humans based on a standard male and female fertility study in rats (see section 5.3).
Slovenian: Predklinični podatki na osnovi standardne študije o plodnosti podganjih samcev in samic niso razkrili nobene nevarnosti za ljudi (glejte poglavje 5.3).
English: The medicine is taken by mouth mixed in liquid or semi-solid food.
Slovenian: Zdravilo se jemlje skozi usta, potem ko se zmeša s tekočino ali redko hrano.
English: No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Pri bolnikih z blago, zmerno ali hudo okvaro jeter prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
English: Patients should maintain adequate hydration while taking ataluren (see section 4.4).
Slovenian: Zato morajo bolniki med jemanjem atalurena poskrbeti za zadostno hidracijo (glejte poglavje 4.4).
English: Because hypertension with use of concomitant systemic corticosteroids was reported for some patients in clinical trials, it is recommended that resting systolic and diastolic blood pressure be monitored every 6 months in nmDMD patients receiving ataluren concomitantly with corticosteroids, or more frequently as needed based on the patient's clinical status.
Slovenian: Ker so pri nekaterih bolnikih, ki so sodelovali v kliničnih preskušanjih, poročali o hipertenziji, povezani s sočasno uporabo sistemskih kortikosteroidov, je priporočljivo, da se pri bolnikih z nmDMD, ki sočasno uporabljajo ataluren in kortikosteroide, vsakih 6 mesecev preverita sistolični in diastolični krvni tlak med mirovanjem, lahko pa tudi pogosteje, če je to potrebno glede na klinično stanje bolnika.
English: Significance of the urinary bladder tumours for humans is considered unlikely.
Slovenian: Verjetnost, da bi bilo odkritje tumorjev sečnega mehurja pomembno za človeka, je majhna.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja eritematozni izpuščaj