FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of sachets
Slovenian: Število vrečic
English: Mean Change in 6-Minute Walk Distance (Study 2)
Slovenian: Povprečna sprememba razdalje, prehojene v 6 minutah (študija 2)
English: Figure 5.
Slovenian: Slika 5.
English: In Study 1, a post hoc analysis of the primary endpoint showed that from baseline to Week 48, patients receiving ataluren 40 mg/kg/day had a 12.9 meters mean decline in 6MWD, and patients receiving placebo had a 44.1-meter mean decline in 6MWD (Figure 1).
Slovenian: V študiji 1 je analiza post hoc primarnega opazovanega dogodka pokazala, da se je 6MWD od izhodišča do 48. tedna pri bolnikih, ki so prejemali ataluren 40 mg/kg/dan, v povprečju skrajšala za 12,9 metra, pri bolnikih, ki so prejemali placebo, pa za 44,1 metra (slika 1).
English: No apparent differences of the total ataluren exposure in the control, mild, and severe hepatic impairment groups were observed.
Slovenian: Opazili niso nikakršnih očitnih sprememb v celokupni izpostavljenosti atalurenu v kontrolni skupini, skupini z blago in skupini s hudo okvaro jeter.
English: Pain in extremity, musculoskeletal chest pain
Slovenian: mišično-skeletna bolečina v prsnem košu
English: No clinically relevant change in the plasma concentrations of corticosteroids was seen with co-administration of ataluren.
Slovenian: Pri sočasni uporabi z atalurenom tudi niso opazili klinično pomembnih sprememb koncentracij kortikosteroidov v plazmi.
English: In addition, a 3 to 8 fold increase in ataluren metabolite has been reported in patients with severe renal impairment (eGFR <30 ml/min).
Slovenian: Poleg tega so pri bolnikih s hudo okvaro ledvic (eGFR < 30 ml/min) poročali o 3- do 8-kratnem povečanju presnovka atalurena.
English: Mean Change in 6-Minute Walk Distance (Study 1)
Slovenian: Povprečna sprememba razdalje, prehojene v 6 minutah (študija 1)
English: Elevations of serum creatinine occurred in several nmCF patients treated with ataluren and intravenous aminoglycosides together with other antibiotics for cystic fibrosis exacerbations.
Slovenian: Pri več bolnikih s cistično fibrozo zaradi nesmiselne mutacije, ki so uporabljali ataluren in aminoglikozide za intravensko uporabo skupaj z drugimi antibiotiki za zdravljenje eksacerbacij cistične fibroze, so se zvišale ravni kreatinina v serumu.
English: Because changes in lipid profile (increased triglycerides and cholesterol) were reported for some patients in clinical trials, it is recommended that total cholesterol, LDL, HDL, and triglycerides be monitored on an annual basis in nonsense mutation Duchenne muscular dystrophy (nmDMD) patients receiving ataluren, 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 spremembah ravni lipidov (zvišanju trigliceridov in holesterola), je priporočljivo, da se pri bolnikih z Duchennovo mišično distrofijo zaradi nesmiselne mutacije (nmDMD, nonsense mutation Duchenne muscular dystrophy), ki prejemajo ataluren, enkrat na leto preverijo ravni skupnega holesterola, holesterola LDL in HDL ter trigliceridov, lahko pa tudi pogosteje, če je to potrebno glede na klinično stanje bolnika.
English: Renal function tests
Slovenian: Preiskave delovanja ledvic
English: If you feel dizzy, do not drive, cycle or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste omotični, ne smete voziti, kolesariti ali upravljati strojev.
English: Medicinal product subject to medical prescription
Slovenian: POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: In a rat distribution study a high adrenal concentration of ataluren was observed.
Slovenian: V študiji porazdelitve pri podganah so opazili veliko koncentracijo atalurena v nadledvični žlezi.
English: Translarna is available in 3 strengths, each containing 125 mg, 250 mg and 1000 mg of the active substance, called ataluren.
Slovenian: Zdravilo Translarna je na voljo v 3 jakostih, ki vsebujejo 125 mg, 250 mg ali 1000 mg učinkovine, imenovane ataluren.
English: Translarna 1000 mg granules for oral suspension Each sachet contains 1000 mg ataluren.
Slovenian: Translarna 1000 mg zrnca za peroralno suspenzijo Ena vrečica vsebuje 1000 mg atalurena.
English: Peak plasma levels of ataluren are attained approximately 1.5 hours after dosing in subjects who received medicinal product within 30 minutes of a meal.
Slovenian: Največje koncentracije atalurena se pri osebah, ki vzamejo zdravilo v 30 minutah pred obrokom, pojavijo približno 1,5 ure po odmerjanju.
English: Drink water or other liquids regularly to avoid dehydration while taking Translarna.
Slovenian: Da preprečite dehidracijo med jemanjem zdravila Translarna, pogosto pijte vodo ali druge tekočine.
English: Translarna 1000 mg granules for oral suspension EU/1/13/902/003
Slovenian: Translarna 1000 mg zrnca za peroralno suspenzijo EU/1/13/902/003
English: These results indicate that fewer patients receiving ataluren 40 mg/kg/day worsened in 6MWD over 48 weeks.
Slovenian: Ti rezultati kažejo, da se je 6MWD v 48 tednih poslabšala pri manj bolnikih, ki so prejemali ataluren 40 mg/kg.
English: Translarna 125 mg granules for oral suspension EU/1/13/902/001
Slovenian: Translarna 125 mg zrnca za peroralno suspenzijo EU/1/13/902/001
English: Ataluren should not be co-administered with intravenous aminoglycosides, based on cases of decreased renal function observed in a clinical trial in patients with nmCF (see section 4.3).
Slovenian: Ataluren se ne sme uporabljati sočasno z aminoglikozidi za intravensko uporabo, saj so v kliničnem preskušanju pri bolnikih s cistično fibrozo zaradi nesmiselne mutacije opazili primere zmanjšanega delovanja ledvic (glejte poglavje 4.3 ).
English: No dose adjustment is required when ataluren is co-administered with medicinal products that are substrates of UGT1A9.
Slovenian: Odmerka pri sočasni uporabi atalurena z zdravili, ki so substrati UGT1A9, ni treba prilagajati.
English: Based on the in vitro studies, ataluren is not expected to be an inhibitor of neither p-gp mediated transport nor of cytochrome P450 mediated metabolism.
Slovenian: Študije in vitro so pokazale, da ni pričakovati, da bi ataluren zaviral prenos s p-glikoproteinom ali presnovo s citokromom P450.
English: This means that further evidence on this medicinal product is awaited.European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu.
English: In timed function tests (TFTs), tests of time to run/walk 10 meters, time to climb 4 stairs, and time to descend 4 stairs, ataluren-treated patients demonstrated smaller increases in the time it takes to run/walk 10 meters, climb 4 stairs, and descend 4 steps, indicating slowing of nmDMD progression relative to placebo.
Slovenian: čas, ki so ga potrebovali za tek/hojo na 10 m, vzpenjanje po 4 stopnicah in spuščanje po 4 stopnicah, manj podaljšal, kar kaže na to, da je ataluren upočasnil napredovanje nmDMD v primerjavi s placebom.
English: The mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in observed time to run/walk 10 meters (better by 1.2 seconds, p=0.117), time to climb 4 stairs (better by 1.8 seconds, p=0.058), and time to descend 4 stairs (better by 1.8 seconds, p=0.012), Figure 5.
Slovenian: Povprečna sprememba v časovno merjenih funkcijskih testih od izhodišča do 48. tedna je bila boljša v skupini z atalurenom 40 mg/kg/dan kot v skupini s placebom, tako pri času teka/hoje na 10 metrov (boljša za 1,2 sekundi, p = 0,117), času vzpenjanja po 4 stopnicah (boljša za 1,8 sekunde, p = 0,058) kot tudi času spuščanja po 4 stopnicah (boljša za 1,8 sekunde, p = 0,012); slika 5.
English: If there is a delay of more than 3 hours after the morning or midday doses or more than 6 hours after the evening dose, the dose should not be taken, and patients should resume their usual dosing schedule.
Slovenian: Če je zamuda več kot 3 ure po jutranjem ali popoldanskem odmerku ali več kot 6 ur po večernem odmerku, bolniki odmerka ne smejo vzeti in morajo nadaljevati z jemanjem odmerkov po običajnem razporedu.
English: Translarna 250 mg granules for oral suspension EU/1/13/902/002
Slovenian: Translarna 250 mg zrnca za peroralno suspenzijo EU/1/13/902/002
English: Translarna 250 mg granules for oral suspension Each sachet contains 250 mg ataluren.
Slovenian: Translarna 250 mg zrnca za peroralno suspenzijo Ena vrečica vsebuje 250 mg atalurena.
English: If you are late in taking Translarna by less than 3 hours after the morning or midday doses, or by less than 6 hours after the evening dose, take the dose.
Slovenian: Če ste zamudili odmerek zdravila Translarna za manj kot 3 ure po jutranjem ali popoldanskem odmerku ali za manj kot 6 ur po večernem odmerku, vzemite odmerek.
English: Translarna 125 mg granules for oral suspension Translarna 250 mg granules for oral suspension Translarna 1000 mg granules for oral suspension
Slovenian: Translarna 125 mg zrnca za peroralno suspenzijo Translarna 250 mg zrnca za peroralno suspenzijo Translarna 1000 mg zrnca za peroralno suspenzijo
English: Thus, the mean change in observed 6MWD from baseline to Week 48 was 31.3 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.056).
Slovenian: 6MWD, ki so jo zabeležili od izhodišča do 48. tedna, je bila torej za 31,3 metra boljša v skupini, ki je prejemala ataluren 40 mg/kg/dan, kot v skupini s placebom (p = 0,056).
English: Granules for oral suspension 30 sachets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Zrnca za peroralno suspenzijo 30 vrečic
English: Nausea, upper abdominal pain, flatulence, abdominal discomfort, constipation
Slovenian: Bolezni prebavil bruhanje navzea, bolečine v zgornjem delu trebuha, flatulenca, neugodje v trebuhu,
English: White to off-white granules.
Slovenian: Bela ali skoraj bela zrnca.
English: Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9 (eg rifampicin).
Slovenian: Kadar se ataluren uporablja sočasno z zdravili, ki so induktorji UGT1A9 (npr. rifampicin), je potrebna previdnost.
English: If there is a delay in the administration of ataluren of less than 3 hours after the morning or midday doses or less than 6 hours after the evening dose, the dose should be taken with no changes to the subsequent dose schedules.
Slovenian: Če je zamuda pri dajanju atalurena manj kot 3 ure po jutranjem ali popoldanskem odmerku ali manj kot 6 ur po večernem odmerku, je treba vzeti odmerek, ne da bi se spremenil časovni razpored jemanja pri naslednjih odmerkih.
English: Because small increases in mean serum creatinine, blood urea nitrogen (BUN), and cystatin C were observed in the controlled studies of nmDMD, it is recommended that serum creatinine, BUN, and cystatin C be monitored every 6 to 12 months in nmDMD patients receiving ataluren, or more frequently as needed based on the patient's clinical status.
Slovenian: Ker so v kontroliranima študijama pri bolnikih z nmDMD opazili rahlo zvišanje povprečnih koncentracij kreatinina v serumu, sečninskega dušika v krvi in cistatina C, je priporočljivo, da se pri bolnikih z nmDMD, ki prejemajo ataluren, vsakih 6 do 12 mesecev preverijo koncentracije kreatinina v serumu, sečninskega dušika v krvi in cistatina C, lahko pa tudi pogosteje, če je to potrebno glede na klinično stanje bolnika.
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services Ltd.
Slovenian: Almac Pharma Services Ltd.
English: No dosage adjustment is required for patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni treba prilagajati.
English: It is unlikely that the pharmacokinetics of ataluren are significantly affected by UGT1A9 polymorphisms in a Caucasian population.
Slovenian: Verjetnost, da bi imeli polimorfizmi UGT1A9 pri populaciji belcev pomembnejši vpliv na farmakokinetiko atalurena, je majhna.
English: If you are late by more than 3 hours after the morning or midday doses, or by more than 6 hours after the evening dose, do not take the dose.
Slovenian: Če ste zamudili odmerek za več kot 3 ure po jutranjem ali popoldanskem odmerku ali za več kot 6 ur po večernem odmerku, odmerka ne vzemite.
English: Translarna is available in sachets of 125 mg, 250 mg or 1000 mg.
Slovenian: Zdravilo Translarna je na voljo v 125-mg, 250-mg ali 1000-mg vrečicah.
English: The amount of the liquid or semi-solid food can be increased based on your preference.
Slovenian: Če želite, lahko količino tekočine ali redke hrane povečate.
English: Paediatric population
Slovenian: Imobilni bolniki
English: In patients with a baseline 6MWD <350 meters, the mean change in observed 6MWD from baseline to Week 48 was 68 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.0053).
Slovenian: Pri bolnikih z izhodiščno 6MWD < 350 metrov je bila povprečna sprememba v razdalji, prehojeni v 6 minutah, ki so jo zabeležili od izhodišča do 48. tedna, za 68 metrov boljša v skupini, ki je prejemala ataluren 40 mg/kg/dan, kot v skupini s placebom (p = 0,0053).
English: Translarna is available in the following sachet strengths: 125 mg, 250 mg and 1000 mg of ataluren per sachet.
Slovenian: Zdravilo Translarna je na voljo v vrečicah z naslednjimi jakostmi: 125 mg, 250 mg in 1000 mg atalurena na vrečico.
English: Granules for oral suspension.
Slovenian: Zrnca za peroralno suspenzijo
English: Common side effects (may affect up to 1 in 10 people): - Decreased appetite - High blood triglyceride levels - Headache - Feeling sick - Weight loss - High blood pressure - Cough - Nosebleed - Constipation - Wind - Stomach discomfort - Stomach pain - Rash - Arm or leg pain - Chest pain - Involuntary urination - Blood in urine - Fever
Slovenian: - zmanjšan tek, - zvišane ravni trigliceridov v krvi, - glavobol, - slabost, - izguba telesne mase, - visok krvni tlak, - kašelj, - krvavitve iz nosa, - zaprtost, - vetrovi,
English: The maternal systemic exposure at the no observed effect level (NOEL) for neonatal toxicity was about 3 times human exposure.
Slovenian: neonatalne toksičnosti je bila približno 3-krat večja od izpostavljenosti pri človeku.
English: Translarna 1000 mg granules for oral suspension ataluren
Slovenian: Translarna 1000 mg zrnca za peroralno suspenzijo ataluren
English: An approximately 40% decrease of mean total ataluren exposure in the moderate hepatic impairment group versus the control group was noted probably due to the small sample size and variability.
Slovenian: Opazili pa so približno 40-odstotno zmanjšanje povprečne celokupne izpostavljenosti atalurenu v skupini z zmerno okvaro jeter, v primerjavi s kontrolno skupino.
English: 250 mg sachets mg sachets
Slovenian: 250-mg vrečice mg vrečice
English: Polydextrose (E1200)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi polidekstroza (E1200)
English: The full contents of each sachet should be mixed with at least 30 ml of liquid (water, milk, fruit juice) or 3 tablespoons of semi-solid food (yoghurt or apple sauce).
Slovenian: Celotno vsebino posamezne vrečice je treba zmešati z najmanj 30 ml tekočine (vode, mleka, sadnega soka) ali s 3 žlicami redke hrane (jogurta ali jabolčne čežane).
English: Contact your doctor if you take more than the recommended dose of Translarna.
Slovenian: Če ste vzeli večji odmerek zdravila Translarna, kot bi smeli Če ste vzeli večji odmerek zdravila Translarna od priporočenega, se posvetujte z zdravnikom.
English: Renal toxicity (nephrosis in the distal nephron) occurred in repeat oral dose studies in mice at systemic exposure equivalent to 0.3 times the steady state AUC in patients administered Translarna at respective morning, midday, and evening doses of 10-, 10-, 20-mg/kg and higher.
Slovenian: V študijah s ponavljajočimi peroralnimi odmerki pri miših se je pojavila toksičnost za ledvice (nefroza v distalnem nefronu) pri sistemski izpostavljenosti, ki je bila enaka 0,3-kratni AUC v stanju dinamičnega ravnovesja pri bolnikih, ki so jemali jutranje, popoldanske in večerne odmerke zdravila
English: The full contents of each sachet should be mixed with at least 30 ml of liquid (water, milk, fruit juice), or 3 tablespoons of semi-solid food (yoghurt or apple sauce).
Slovenian: Celotno vsebino posamezne vrečice je treba zmešati z najmanj 30 ml tekočine (vode, mleka, sadnega soka), ali s 3 žlicami redke hrane (jogurta ali jabolčne čežane).
English: Mix the prepared dose well before taking it.
Slovenian: Preden vzamete pripravljeni odmerek, ga dobro premešajte.
English: A post-hoc analysis of time to persistent 10% worsening in 6MWD showed that 26% of patients in the ataluren 40 mg/kg/day arm had progressed at Week 48 compared to 44% in the placebo group (p=0.0652) (Figure 2).
Slovenian: 48 tednih do tega prišlo pri 26 % bolnikov v skupini z atalurenom 40 mg/kg/dan, v primerjavi s 44 % bolnikov v skupini s placebom (p = 0,0652) (slika 2).
English: ≥150 meters and less than 80% predicted without the need for assistive devices during a screening
Slovenian: Vsi bolniki so morali biti v presejalnem 6-minutnem testu hoje sposobni prehoditi ≥ 150 metrov in manj kot 80 % predvidene vrednosti ne da bi potrebovali medicinsko-tehnične pripomočke.
English: Caution should be exercised when ataluren is co-administered with adefovir.
Slovenian: Ob sočasnem dajanju atalurena in adefovirja je potrebna previdnost.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: Translarna may not be as effective in treating your symptoms if you take more than the recommended dose.
Slovenian: Če boste vzeli večji odmerek od priporočenega, zdravilo Translarna morda ne bo tako učinkovito pri zdravljenju vaših simptomov.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Aluminium sachet
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: In the ITT population, the difference between the ataluren and placebo arms in mean change in observed 6MWD from baseline to Week 48 was 15.4 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm.
Slovenian: V populaciji z namenom zdravljenja (ITT, intent-to-treat) je bila povprečna razlika med krakom z atalurenom in placebom v spremembi 6MWD od izhodišča do 48. tedna, za 15,4 metra boljša v kraku z atalurenom 40 mg/kg/dan kot v kraku s placebom.
English: In the urine, unchanged ataluren and the acyl glucuronide metabolite account for <1% and 49%, respectively, of the administered dose.
Slovenian: < 1 % danega odmerka v urinu predstavlja ataluren v nespremenjeni obliki, 49 % pa acil glukuronidni presnovek.
English: Respiratory, thoracic, and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, epistaksa
English: The recommended dose is the same for all age ranges, i.e. 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (for a total daily dose of 40 mg/kg body weight).
Slovenian: Priporočeni odmerek je enak za vse razpone starosti, in je 10 mg/kg telesne mase zjutraj, 10 mg/kg telesne mase opoldne in 20 mg/kg telesne mase zvečer (za skupni dnevni odmerek 40 mg/kg telesne mase).
English: In these patients, the mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in time to run/walk 10 meters (better by 3.5 seconds), time to climb 4 stairs (better by 6.4 seconds), and time to descend 4 stairs (better by 5.0 seconds).
Slovenian: Povprečna sprememba v časovno merjenih funkcijskih testih od izhodišča do 48. tedna je bila pri teh bolnikih boljša v skupini z atalurenom 40 mg/kg/dan kot v skupini s placebom, tako pri času teka/hoje na 10 metrov (boljša za 3,5 sekunde), času vzpenjanja po 4 stopnicah (boljša za 6,4 sekunde) kot tudi času spuščanja po 4 stopnicah (boljša za 5,0 sekund).
English: Translarna 125 mg granules for oral suspension ataluren
Slovenian: Translarna 125 mg zrnca za peroralno suspenzijo ataluren
English: The mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in time to run/walk 10 meters (better by 1.5 seconds), time to climb 4 stairs (better by 2.4 seconds), and time to descend 4 stairs (better by 1.6 seconds), Figure 3.
Slovenian: Povprečna sprememba v časovno merjenih funkcijskih testih od izhodišča do 48. tedna je bila boljša v skupini z atalurenom 40 mg/kg/dan kot v skupini s placebom, tako pri času teka/hoje na 10 metrov (boljša za 1,5 sekunde), času vzpenjanja po 4 stopnicah (boljša za 2,4 sekunde) kot tudi času spuščanja po 4 stopnicah (boljša za 1,6 sekunde); slika 3.
English: Change in lipid profile (increased triglycerides and cholesterol)
Slovenian: Presnovne in prehranske motnje zmanjšan tek, hipertrigliceridemija spremembe ravni lipidov (zvišane ravni trigliceridov in holesterola)
English: Meters (±SE)
Slovenian: NN: {številka}
English: Patients must have a nonsense mutation in the dystrophin gene as part of their underlying disease state, as determined by genetic testing.
Slovenian: Osnovna bolezen bolnikov mora biti posledica nesmiselne mutacije gena za distrofin, ki je bila ugotovljena z genetskimi preiskavami.
English: An increase in ataluren exposure and in ataluren metabolite has been reported in patients with severe renal impairment (eGFR <30 ml/min).
Slovenian: Pri bolnikih s hudo okvaro ledvic (eGFR < 30 ml/min) so poročali o povečanju izpostavljenosti atalurenu in njegovem presnovku.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v udih,
English: In vivo, the only metabolite detected in plasma after oral administration of radio-labelled ataluren was the ataluren-O-1β-acyl glucuronide; exposure to this metabolite in humans was approximately 8% of the plasma AUC of ataluren.
Slovenian: In vivo je bil edini presnovek, opažen v plazmi po peroralnem dajanju radioaktivno označenega atalurena, ataluren-O-1β-acil glukuronid.
English: How to store Translarna
Slovenian: Shranjevanje zdravila Translarna
English: Translarna 125 mg granules for oral suspension Each sachet contains 125 mg ataluren.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Translarna 125 mg zrnca za peroralno suspenzijo Ena vrečica vsebuje 125 mg atalurena.
English: Translarna 250 mg granules for oral suspension ataluren
Slovenian: Translarna 250 mg zrnca za peroralno suspenzijo ataluren
English: The amount of the liquid or semi-solid food can be increased based on patient preference.
Slovenian: Če bolnik želi, lahko količino tekočine ali redke hrane poveča.
English: The recommended dose is 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (for a total daily dose of 40 mg/kg body weight).
Slovenian: Priporočeni odmerek je 10 mg/kg telesne mase zjutraj, 10 mg/kg telesne mase popoldne in 20 mg/kg telesne mase zvečer (skupni dnevni odmerek je torej 40 mg/kg telesne mase).
English: The recommended dose is 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (adding up to a total daily dose of 40 mg/kg body weight).
Slovenian: Priporočeni odmerek je 10 mg/kg telesne mase zjutraj, 10 mg/kg telesne mase zgodaj popoldne in 20 mg/kg telesne mase zvečer (to pomeni, da je skupni dnevni odmerek 40 mg/kg telesne mase).
English: Each sachet contains 1000 mg of ataluren
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena vrečica vsebuje 1000 mg atalurena
English: The pharmacokinetics of ataluren are unlikely to be affected by medicinal products that inhibit the p-glycoprotein transporter.
Slovenian: Verjetnost, da bi zdravila, ki zavirajo prenašalec p-glikoprotein, vplivala na farmakokinetiko atalurena, je majhna.
English: Placental transfer was shown of radiolabelled ataluren in rats.
Slovenian: Pri podganah so opazili, da je radioaktivno označen ataluren prehajal skozi placento.