natgillin/translations-raw huggingface dataset:
Based on the physical-chemical and biopharmaceutical properties (very low oral bioavailability), eluxadoline is expected to have minimal abuse or dependence liability.
Na temelju fizičko-kemijskih i biofarmaceutskih svojstava (vrlo niska bioraspoloživost nakon peroralne primjene), očekuje se da će eluksadolin imati minimalan utjecaj na zlouporabu ili ovisnost.
Based on the PK, safety, and efficacy trial simulation results, a starting dose of approximately 25 mg/m2/day on schedule 4/2 in paediatric patients with GIST (ages 6-11 and 12-17 years) is predicted to provide comparable sunitinib plasma exposures, and subsequently safety and efficacy to those in adult patients with GIST treated at 50 mg/day on schedule 4/2.
Na temelju rezultata simulacije ispitivanja FK, sigurnosti i djelotvornosti, predviđa se da će početna doza od približno 25 mg/m2/dan po shemi 4/2 kod pedijatrijskih bolesnika s GIST-om (u dobi od 6-11 i 12-17 godina) pružati usporedne vrijednosti izloženosti sunitiniba u plazmi, te posljedično sigurnost i djelotvornost, s onima kod odraslih bolesnika s GIST-om liječenih pri 50 mg/dan po shemi 4/2.
Based on the population pharmacokinetic analysis in HCV-infected patients, geometric mean steady-state AUC0-24 for ledipasvir (n = 2,113), sofosbuvir (n = 1,542), and GS-331007 (n = 2,113) were 7,290, 1,320 and 12,000 ng•h/mL, respectively.
Na temelju analize populacijske farmakokinetike u pacijenata zaraženih HCV-om, geometrijska srednja vrijednost AUC0-24 u stanju dinamičke ravnoteže za ledipasvir (n = 2113), sofosbuvir (n = 1542) i GS-331007 (n = 2113) iznosila je 7290, 1320 odnosno 12 000 ng•h/ml.
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, the predicted steady-state AUC (95% CI) was 23%-37% higher in Asian patients (N=523) than in non- Asian patients (N=691).
Na temelju populacijske farmakokinetičke analize podataka iz Ispitivanja 1001, 1005 i 1007, očekivani AUC u stanju dinamičke ravnoteže (95% CI) bio je 23%-37% viši u bolesnika azijskog podrijetla (N=523) nego u bolesnika drugih rasa (N=691).
Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 MabThera once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 to 49 days).
Na temelju populacijske farmakokinetičke analize podataka za 97 bolesnika s s granulomatozom s poliangitisom i mikroskopskim poliangitisom koji su primali lijek MabThera u dozi od 375 mg/m2 jedanput tjedno tijekom četiri tjedna, procijenjen medijan terminalnog poluvremena eliminacije bio je 23 dana (raspon od 9 do 49 dana).
Based on the population pharmacokinetic analysis, 12- to 14- year-old adolescents weighing less than 50 kg should receive children's doses (see section 4.2).
Na osnovu populacijske farmakokinetičke analize, adolescenti u dobi od 12-14 godina koji teže manje od 50 kg trebaju primati doze za djecu (vidjeti dio 4.2)
Based on the population pharmacokinetic analysis, 12- to 14- year-old adolescents weighing less than 50 kg should receive children’s doses (see section 4.2).
Na osnovu populacijske farmakokinetičke analize, adolescenti u dobi od 12-14 godina koji teže manje od 50 kg trebaju primati doze za djecu (vidjeti dio 4.2).
Based on the population pharmacokinetic analysis, no significant difference was observed in the pharmacokinetics of Perjeta between patients < 65 years (n=306) and patients ≥ 65 years (n=175).
U populacijskoj farmakokinetičkoj analizi nije opažena značajna razlika u farmakokinetici lijeka Perjeta između bolesnika mlađih od 65 godina (n=306) i bolesnika u dobi od ≥ 65 godina (n=175).
Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46%) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Na temelju rezultata populacijske farmakokinetičke analize, koja je uključivala bolesnike širokoga dobnog raspona (od 27 do 86 godina) te 234 (46%) bolesnika od 65 godina ili starijih, ustanovljeno je da dob nema utjecaja na farmakokinetiku 5'-DFUR i 5-FU.
Based on the population pharmacokinetics analysis (range 19 to 92 years), age had no relevant clinical effect on trametinib pharmacokinetics.
Na temelju populacijske farmakokinetičke analize (u rasponu od 19 do 92 godine), dob nije imala klinički značajnog utjecaja na farmakokinetiku trametiniba.
Based on the population PK analysis the exposure to daratumumab was similar between white (n = 197) and non-white (n = 26) subjects.
Prema populacijskoj farmakokinetičkoj analizi, izloženost daratumumabu bile su slične u bijelaca (n = 197) i ispitanika drugih rasa (n = 26).
Based on the population PK analysis, daratumumab steady state is achieved approximately 5 months into the every 4-week dosing period (by the 21st infusion), and the mean (SD) ratio of Cmax at steady-state to Cmax after the first dose was 1.6 (0.5).
Prema populacijskoj farmakokinetičkoj analizi, daratumumab postiže stanje dinamičke ravnoteže približno 5 mjeseci nakon početka razdoblja primjene jedanput svaka 4 tjedna (do 21. infuzije), a srednja vrijednost (SD) omjera Cmax u stanju dinamičke ravnoteže i Cmax nakon prve doze iznosila je 1,6 (0,5).
Based on the population PK analysis, liver function parameters including alkaline phosphatase (ALP, 36-2322 U/L), aspartate aminotransferase (AST, 11-197 U/L), alanine aminotransferase (ALT, 5-182 U/L) , and total bilirubin (0.17-3.20 mg/dL) were not significant covariates for PK parameters of either trifluridine or tipiracil hydrochloride.
Temeljem analize populacijske PK, parametri funkcije jetre uključujući alkalnu fosfatazu (ALP, 36- 2322 U/L), aspartat aminotransferazu (AST, 11-197 U/L), alanin aminotransferazu (ALT, 5-182 U/L) , i ukupni bilirubin (0,17-3,20 mg/dL), nisu bili značajne kovarijante za PK parametre niti za trifluridin niti tipiracilklorid.
Based on the population- pharmacokinetic (PK) model, the volume of distribution (V/F) is approximately 349 L (SE: ± 2.73%).
Na osnovu populacijisko-farmakokinetičkog (PK) modela, volumen distribucije (V/F) iznosi otprilike 349 L (SE: ± 2,73%).
Based on the population- pharmacokinetic (PK) model, the volume of distribution (V/F) is approximately 349 L (SE: ± 2.73%).
Na osnovu populacijsko-farmakokinetičkog (PK) modela, volumen distribucije (V/F) iznosi otprilike 349 L (SE: ± 2,73%).
Based on the population- pharmacokinetic (PK) model, the volume of distribution (Vz) is approximately 319 L (SE: ± 2.7%).
Na osnovi populacijsko- farmakokinetičkog (PK) modela, volumen distribucije (Vz) iznosi otprilike 319 l (SE: ± 2,7 %).
Based on the rare occurrence of haemophilia A in women, experience regarding the treatment during pregnancy and breastfeeding is not available.
Na temelju rijetke pojavnosti hemofilije A u žena nisu dostupna iskustva s liječenjem tijekom trudnoće i dojenja.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast feeding is not available.
Zbog rijetke pojave hemofilije A kod žena nema dostupnih iskustva u pogledu primjene faktora VIII tijekom trudnoće i dojenja.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast- feeding is not available.
Budući da se hemofilija B rijetko javlja u žena, iskustva s primjenom faktora IX tijekom trudnoće i dojenja nisu dostupna.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast- feeding is not available.
Uslijed rijetke pojave hemofilije B u žena, nisu dostupna iskustva u svezi s primjenom faktora IX tijekom trudnoće i dojenja.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available.
Uslijed rijetke pojave hemofilije B u žena, nisu dostupna iskustva u svezi s korištenjem faktora IX tijekom trudnoće i dojenja.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available.
Zbog rijetke pojave hemofilije B u žena, nije dostupno iskustvo s primjenom faktora IX tijekom trudnoće i dojenja.
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81 % of the dose was recovered within 7 days in faeces (68 % of dose) and urine (13 % of dose).
Na temelju izlučivanja spoja(eva) nakon oralne, 14C-označene doze imatiniba, oko 81 % doze izlučilo se u roku od 7 dana u stolici (68 % doze) i mokraći (13 % doze).
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Na temelju izlučivanja spoja(eva) nakon oralne 14C-označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Na temelju izlučivanja spoja(eva) nakon oralne, pomoću 14C- označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Na temelju izlučivanja spoja(eva) nakon oralne, pomoću 14C-označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
Based on the reported cases and the suggested mechanism of action, it is deemed appropriate to include the risk of renal failure and acute renal failure as a new warning and as a new adverse drug reaction in the summary of product characteristics.
Na temelju prijavljenih slučajeva i predloženog mehanizma djelovanja, smatra se primjerenim uključiti rizik od zatajenja bubrega i akutnog zatajenja bubrega kao novo upozorenje te kao novu nuspojavu lijeka u sažetak opisa svojstava lijeka.
Based on the reported cases, it is deemed appropriate to include ‘limbal stem cell deficiency’ as a adverse drug reaction in the table regarding corneal disorders in the summary of product characteristics.
Na temelju zabilježenih slučajeva, smatra se primjerenim uključiti u tablicu ‘nedostatak limbalnih matičnih stanica’ kao nuspojavu koja se odnosi na poremećaje rožnice u Sažetku opisa svojstava lijeka.
Based on the required dose for the patient expressed in mg, withdraw aseptically the corresponding volume containing 20 mg dexrazoxane per ml from the appropriate number of vials containing concentrate.
Ovisno o potrebnoj dozi za pacijenta izraženoj u mg, aseptički izvucite odgovarajući volumen s 20 mg deksrazoksana po ml iz odgovarajućeg broja bočica s koncentratom.
Based on the required dose for the patient, withdraw the necessary volume of ZALTRAP concentrate from the vial.
Na temelju doze koja je potrebna za bolesnika izvucite odgovarajući volumen ZALTRAP koncentrata iz bočice.
Based on the results from clinical trials with other authorized erythropoietins approximately 8% of patients treated with erythropoietin are expected to experience adverse reactions.
Na temelju rezultata kliničkih ispitivanja s drugim odobrenim eritropoetiima, kod približno 8% bolesnika liječenih eritropoetinom mogu se očekivati neželjene reakcije.
Based on the results from clinical trials with other authorized erythropoietins approximately 8% of patients treated with erythropoietin are expected to experience adverse reactions.
Na temelju rezultata kliničkih ispitivanja s drugim odobrenim eritropoetiima, kod približno 8% bolesnika liječenih eritropoetinom mogu se očekivati nuspojave.
Based on the results from this study, Aptivus oral solution might be expected to have a similar interaction profile as the capsules.
Stoga se može očekivati sličan profil interakcija Aptivus oralne otopine i kapsula.
Based on the results of a Phase 3 study in mantle cell lymphoma, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopaenia, lymphopaenia, myalgia, arthralgia, taste loss, dizziness, upper respiratory infection, mucositis, and rhinitis.
Na temelju rezultata ispitivanja faze III limfoma plaštenih stanica, vjerojatnost nastanka određenih nuspojava u starijih bolesnika (u dobi od 65 godina), uključujući nastanak pleuralnog izljeva, tjeskobe, depresije, nesanice, dispneje, leukopenije, limfopenije, mialgije, artralgije, gubitka osjeta okusa, omaglice, infekcije gornjih dišnih puteva, mukozitisa i rinitisa.
Based on the results of a Phase 3 study in renal cell carcinoma, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including oedema, diarrhoea, and pneumonia.
Na temelju rezultata ispitivanja faze III karcinoma bubrežnih stanica, vjerojatnost nastanka određenih nuspojava može biti veća u starijih bolesnika (u dobi od 65 godina), uključujući edeme, proljev i upalu pluća.
Based on the results of a population pharmacokinetic analysis, the enoxaparin sodium kinetic profile is not different in elderly subjects compared to younger subjects when renal function is normal.
Na temelju rezultata analize populacijske farmakokinetike, farmakokinetički profil enoksaparinnatrija ne razlikuje se u starijih ispitanika u usporedbi s mlađim ispitanicima ako je funkcija bubrega normalna.
Based on the results of a single dose administration study of recommended doses of oral mycophenolate mofetil and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that co- administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Na temelju rezultata ispitivanja jednokratne primjene oralnog mofetilmikofenolata i intravenskog ganciklovira u preporučenoj dozi te poznatih učinaka oštećenja bubrega na farmakokinetiku mofetilmikofenolata (vidjeti dio 4.2) i ganciklovira, pretpostavilo se da će istodobna primjena tih lijekova (koji se natječu za mehanizam bubrežnog tubularnog izlučivanja) rezultirati povećanjem koncentracija MPAG-a i ganciklovira.
Based on the results of Analysis of Variance (ANOVA), body weight is the main covariate of exposure (by Cmax and AUC) in relapsing remitting multiple sclerosis (RRMS) subjects, but did not affect safety and efficacy measures evaluated in the clinical studies.
Na temelju rezultata analize varijance (ANOVA), tjelesna težina je glavna kovarijata izloženosti (prema Cmax i AUC) u ispitanika s relapsno-remitirajućom multiplom sklerozom (RRMS), ali ne utječe na mjere sigurnosti i djelotvornosti procijenjene u kliničkim ispitivanjima.
Based on the results of both PFS and OS endpoints, the Data Monitoring Committee established for this study recommended that the study be completed and patients in the HD-Dex arm be crossed over to the Pom + LD-Dex arm.
Na temelju rezultata ishoda PFS-a i ukupnog preživljenja, odbor za nadzor podataka uspostavljen za ovo ispitivanje preporučio je da se ispitivanje dovrši i da se bolesnici iz skupine HD-Dex prebace u skupinu Pom + LD-Dex.
Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
Na osnovi rezultata kliničkih ispitivanja preporučuje se liječenje u trajanju od najmanje šest mjeseci.
Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
Na osnovi rezultata kliničkih ispitivanja, preporučuje se liječenje u trajanju od najmanje šest mjeseci.
Based on the results of drug-drug clinical interaction studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded.
Na temelju rezultata kliničkih ispitivanja interakcija lijekova (npr. escitalopram, zolpidem, etinilestradiol) indukcija metaboličkih enzima telaprevirom se ne može isključiti.
Based on the results of drug-drug interaction clinical studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded.
Na osnovu rezultata kliničkih ispitivanja interakcija lijekova (npr. escitalopram, zolpidem, etinilestradiol), indukcija metaboličkih enzima telaprevirom se ne može isključiti.
Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450-mediated interactions involving tenofovir with other medicinal products is low.
Na temelju rezultata in vitro pokusa i s obzirom na poznati put izlučivanja tenofovira, potencijal za interakcije posredstvom CYP450, koje uključuju tenofovirdizoproksilfumarat s drugim lijekovima, je nizak.
Based on the results of in vitro studies, a part of oteracil is non-enzymatically degraded to 5-azauracil (5-AZU) by gastric fluid, and is then converted to cyanuric acid (CA) in the digestive tract.
Bazirano na rezultatima in vitro studija, dio oteracila se neenzimatski razgrađuje želučanim sokovima u 5-azauracil (5- AZU), a potom konvertira u probavnom traktu u cijanurnu kiselinu (CA).
Based on the results of in vitro studies, a part of oteracil is non-enzymatically degraded to 5-azauracil (5-AZU) by gastric fluid, and is then converted to cyanuric acid (CA) in the digestive tract.
Bazirano na rezultatima in vitro studija, dio oteracila se neenzimatski razgrađuje želučanim sokovima u 5-azauracil (5-AZU), a potom konvertira u probavnom traktu u cijanurnu kiselinu (CA).
Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Na temelju rezultata ispitivanja peroralne primjene u miševa i štakora zaključeno je da olanzapin nije kancerogen.
Based on the results of population pharmacokinetic analyses that included Caucasian, African American/African, Asian and Hispanic/Non-Hispanic patients, race and ethnicity had no clinically meaningful effect on the pharmacokinetics of Eperzan clearance.
S obzirom na rezultate populacijskih farmakokinetičkih analiza koje su uključivale bijelce, Afroamerikance/Afrikance, Azijate, Hispanoamerikance te bolesnike koji nisu hispanoameričkog podrijetla, rasa i etničko podrijetlo nisu klinički značajno utjecali na farmakokinetiku klirensa lijeka Eperzan.
Based on the results of study BM 16550, ibandronic acid 3 mg intravenous injection, administered every 3 months is expected to be at least as effective in preventing fractures as the oral regimen of ibandronic acid 2.5 mg daily.
Na temelju rezultata ispitivanja BM 16550 procjenjuje se da će intravenska injekcija ibandronatne kiseline od 3mg koja se daje svaka tri mjeseca biti barem jednako djelotvorna u sprječavanju prijeloma kao peroralna doza ibandronatne kiseline od 2,5mg koja se uzima jedanput dnevno.
Based on the results of the cumulative evaluations and considering the pharmacological plausibility of anticholinergic effect on urinary function, there is sufficiently robust evidence to warrant an update of the Product Information with ‘urinary retention, bladder outlet obstruction and dysuria" as ADRs associated to UMEC/VI.
Na temelju rezultata kumulativnih ocjena i uzimajući u obzir farmakološku vjerojatnost antikolinergičkog učinka na mokraćnu funkciju, postoji dovoljno robusnih dokaza koji opravdavaju ažuriranje informacija o lijeku kako bi se „urinarna retencija , opstrukcija pražnjenja mjehura i dizurija“ uvrstile kao nuspojave povezane s primjenom umeklidinijeva bromida/vilanterola.
Based on the results of the phase 3 studies, elderly patients may be more likely to experience certain adverse reactions, including face oedema, pneumonia, pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopaenia, lymphopaenia, myalgia, arthralgia, ageusia, dizziness, upper respiratory infection, mucositis, and rhinitis.
Na temelju rezultata faze III ispitivanja , u starijih bolesnika može postojati veća vjerojatnost nastanka određenih nuspojava, uključujući edem lica, upalu pluća, pleuralni izljev, anksioznost, depresiju, nesanicu, dispneju, leukopeniju, limfopeniju, mijalgiju, artralgiju, ageuziju, omaglicu, infekciju gornjih dišnih puteva, mukozitis i rinitis.
Based on the results of the population pharmacokinetic analysis, Perjeta exposure in patients with mild (creatinine clearance [CLcr] 60 to 90 ml/min, N=200) and moderate renal impairment (CLcr 30 to 60 ml/min, N=71) was similar to that in patients with normal renal function (CLcr greater than 90 ml/min, N=200).
Rezultati populacijske farmakokinetičke analize pokazuju da je izloženost lijeku Perjeta u bolesnika s blagim (klirens kreatinina [CLcr] 60 do 90 ml/min, N=200) i umjerenim oštećenjem bubrežne funkcije (CLcr 30 do 60 ml/min, N=71) bila podjednaka onoj u bolesnika s normalnom bubrežnom funkcijom (CLcr iznad 90 ml/min, N=200).
Based on the results of the studies, the Committee decided that Ozurdex’s benefits are greater than its risks in patients with uveitis or macular oedema related to blocked veins, and recommended that it be given marketing authorisation.
Na temelju rezultata ispitivanja Odbor je odlučio da korist od lijeka Ozurdex nadmašuje s njim povezane rizike kod bolesnika s uveitisom ili makularnim edemom povezanim s blokiranim venama i preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between Zoledronic acid Teva therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Na osnovi pregleda i kliničkih ispitivanja i post-marketinškog praćenja, postoje dostatni dokazi koji podupiru postojanje veze između liječenja Zoledronatnom kiselinom Teva, prijavljenih slučajeva hipokalcemije i sekundarnog razvoja srčanih aritmija.
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Na temelju pregleda kliničkih i postmarkatinških ispitivanja, postoji dovoljno dokaza koji podupiru povezanost liječenja zoledronatnom kiselinom i prijavljenih slučajeva hipokalcemije i posljedičnog razvoja srčane aritmije.
Based on the similar reslizumab exposure observed in patients older than 65 years of age as compared to patients 18 to <65 years of age, no dose adjustment is recommended (see section 5.2).
Na temelju slične izloženosti reslizumabu u bolesnika starijih od 65 godina u usporedbi s bolesnicima u dobi od 18 do <65 godina, ne preporučuje se prilagodba doze (vidjeti dio 5.2).
Based on the stratified Cochran-Mantel-Haenszel test (2-sided).
Na temelju stratificiranog Cochran-Mantel-Haenszelovog testa (2-stranog).
Based on the stratified log-rank test (1-sided).
Na temelju stratificiranog log-rang testa (1-stranog).
Based on the stratified log-rank test (1-sided).
Na temelju stratificiranog log-rang testa (1-stranog). d.
Based on the study design, patients whose tender and swollen joint counts had not improved by at least 20% were considered non-responders at Week 16.
Prema planu ispitivanja, bolesnici u kojih nije nastupilo poboljšanje u broju bolnih i otečenih zglobova za najmanje 20%, smatrani su u 16. tjednu bolesnicima bez odgovora.
Based on the three cases of SJS and the potentially life-threatening and severe consequences of the event SJS/TEN an update of section 4.8 of the SmPC is recommended.
Na temelju ta tri slučaja SJS-a i potencijalno životno opasnih i teških posljedica događaja SJS/TEN, preporučuje se ažurirati dio 4.8 Sažetka opisa svojstava lijeka.
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%.
Na temelju radioaktivnosti zabilježene u urinu u ispitivanju jedne doze radiološki označenog atalurena, oralna bioraspoloživost atalurena je procijenjena na >55%.