FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Types of kidney injury characterized by inflammation (acute interstitial nephritis) or damage to the tubules of the kidney (acute tubular necrosis).
Slovenian: • vrsti ledvičnih poškodb, za kateri je značilno vnetje (akutni intersticijski nefritis) ali poškodovani ledvični tubuli (akutna tubulna nekroza).
English: The geometric mean ratios between the fed and fasted states for Cmax and AUC were 2.5 and 4.6 to 5.1 fold, respectively.
Slovenian: Povprečno geometrično razmerje za Cmax in AUC med jemanjem na tešče in s hrano, je bilo 2,5 in 4,6 do 5,1.
English: The primary efficacy objective of the study was best overall response rate (BORR) in the brain of metastatic melanoma patients with previously untreated brain metastases, as assessed by an independent review committee (IRC).
Slovenian: Primarni cilj učinkovitosti študije je bil delež najboljšega celokupnega odziva (BORR, best overall response rate) v možganih bolnikov z metastatskim melanomom, katerih zasevkov v možganih še niso zdravili, po oceni odbora za neodvisni pregled (IRC).
English: Limited pharmacokinetic data from six adolescent patients aged between 15 and 17 years with stage IIIC or IV BRAF V600 mutation positive melanoma suggest that vemurafenib pharmacokinetic characteristics in adolescents are generally similar to those in adults.
Slovenian: Omejeni farmakokinetični podatki šestih mladostnikov, starih med 15 in 17 let, z melanomom v stadiju IIIC ali IV s pozitivno mutacijo BRAF V600 kažejo, da so farmakokinetične značilnosti vemurafeniba pri mladostnikih v splošnem podobne tistim pri odraslih.
English: Of the patients who experienced cuSCC, approximately 33% experienced > 1 occurrence with median time between occurrences of 6 weeks.
Slovenian: Med bolniki, pri katerih se je pojavil ploščatocelični karcinom kože, je bilo približno 33 % takšnih, pri katerih se je pojavil več kot enkrat; mediana časa med pojavi je bila 6 tednov.
English: New primary melanomas have been reported in clinical trials.
Slovenian: V kliničnih preskušanjih so poročali o novih primarnih melanomih.
English: Two patients (1.5%) developed treatment-emergent absolute QTc values >500 ms (CTC Grade 3), and only one patient (0.8%) exhibited a QTc change from baseline of >60 ms (see section 4.4).
Slovenian: Pri dveh bolnikih (1,5 %) so se pojavile med zdravljenjem nastale absolutne vrednosti intervala QTc > 500 ms (stopnje 3 po CTC) in le enemu bolniku (0,8 %) se je interval QTc od izhodišča spremenil za > 60 ms (glejte poglavje 4.4).
English: The mean QTc effect remained stable between 12-15 ms beyond the first month of treatment, with the largest mean QTc prolongation (15.1 ms; upper 95% CI: 17.7 ms) observed within the first 6 months (n=90 patients).
Slovenian: Povprečni učinek na interval QTc je ostal po prvem mesecu zdravljenja stabilen med 12 in 15 ms, z najdaljšim povprečnim podaljšanjem intervala QTc (15,1 ms, zgornja meja 95-% intervala zaupanja: 17,7 ms), ugotovljenim v prvih 6 mesecih (n = 90 bolnikov).
English: Due to the long half-life of vemurafenib, the full inhibitory effect of vemurafenib on a concomitant medicinal product might not be observed before 8 days of vemurafenib treatment.
Slovenian: Zaradi dolge razpolovne dobe vemurafeniba je mogoče, da popolnega zaviralnega učinka vemurafeniba na sočasno dajano zdravilo ne opazimo, dokler ne mine 8 dni zdravljenja z vemurafenibom.
English: In a clinical study, co-administration of a single dose 960 mg of vemurafenib with rifampicin, significantly decreased the plasma exposure of vemurafenib by approximately 40%.
Slovenian: V klinični študiji je sočasna uporaba enkratnega 960-mg odmerka vemurafeniba z rifampicinom značilno zmanjšala izpostavljenost vemurafenibu v plazmi za približno 40 %.
English: Based on the population PK analysis, age has no statistically significant effect on vemurafenib pharmacokinetics.
Slovenian: Populacijska farmakokinetična analiza kaže, da starost nima pomembnega vpliva na farmakokinetiko vemurafeniba.
English: CYP3A4 is the primary enzyme responsible for the metabolism of vemurafenib in vitro.
Slovenian: CYP3A4 je primarni encim, ki je odgovoren za presnavljanje vemurafeniba in vitro.
English: ● If you forget a dose and it is more than 4 hours before your next dose, just take your dose as soon as you remember it. Take the next dose at the usual time.
Slovenian: • Če ste pozabili vzeti odmerek, naslednjega pa naj bi vzeli več kot čez 4 ure, preprosto vzemite odmerek takoj, ko se spomnite.
English: Vemurafenib might decrease the efficacy of hormonal contraceptives (see section 4.5).
Slovenian: Vemurafenib lahko zmanjša učinkovitost hormonskih kontraceptivov (glejte poglavje 4.5).
English: The population elimination half-life estimated by the population PK analysis for vemurafenib is 51.6 hours (the 5th and 95th percentile range of the individual half-life estimates is 29.8 - 119.5 hours).
Slovenian: Populacijski eliminacijski razpolovni čas, ocenjen s populacijsko farmakokinetično analizo za vemurafenib, je 51,6 ure (razpon od 5. do 95. percentila eliminacijskega časa, ocenjenega individualno, je od 29,8 do 119,5 ure).
English: ● Blockage of blood flow to part of the eye (retinal vein occlusion)
Slovenian: • zaviranje pretoka krvi v dele očesa (zapora mrežnice vene),
English: Your doctor will also do some blood tests to check your liver and kidney functions before you start taking Zelboraf and during treatment.
Slovenian: Zdravnik bo opravil tudi določene preiskave krvi, s katerimi bo preveril delovanje jeter in ledvic pred začetkom zdravljenja in med zdravljenjem z zdravilom
English: Based on preclinical data and the human mass balance study, major part of vemurafenib is eliminated via the liver.
Slovenian: Kot kažejo predklinični podatki in raziskava masnega ravnovesja pri človeku, se večji del vemurafeniba odstrani skozi jetra.
English: Although transient tumour regressions were seen, the best overall response rate (BORR) was 0% (95% CI: 0%, 46%) based on confirmed responses.
Slovenian: Čeprav so opazili prehodna zmanjšanja tumorjev, je bil glede na potrjene odzive delež najboljšega celokupnega odziva (BORR) 0 % (95-% IZ: 0 %, 46 %).
English: ● A type of severe skin reaction characterised by rash accompanied by fever and inflammation of internal organs such as liver and kidney
Slovenian: • vrsta hude kožne reakcije, za katero je značilen izpuščaj, povezan z zvišano telesno temperaturo in vnetjem notranjih organov, kot so jetra in ledvice,
English: • To grade 3
Slovenian: • do stopnje 3
English: Monitoring should continue for 6 months following discontinuation of vemurafenib or until initiation of another anti-neoplastic therapy.
Slovenian: Nadzor se mora nadaljevati še 6 mesecev po prenehanju zdravljenja z vemurafenibom ali do uvedbe drugega antineoplastičnega zdravljenja.
English: Other malignancies
Slovenian: Druge malignosti
English: Table 6: Kinase inhibitory activity of vemurafenib against different BRAF kinases Kinase
Slovenian: Preglednica 6: Inhibitorna kinazna aktivnost vemurafeniba pri različnih BRAF kinazah
English: ● Film-coating: iron oxide red, macrogol 3350, polyvinyl alcohol, talc and titanium dioxide.
Slovenian: • filmska obloga: rdeči železov oksid, makrogol 3350, polivinilalkohol, smukec, titanov dioksid.
English: If during treatment the QTc exceeds 500 ms, vemurafenib treatment should be temporarily interrupted, electrolyte abnormalities (including magnesium) should be corrected, and cardiac risk factors for QT prolongation (e.g. congestive heart failure, bradyarrhythmias) should be controlled.
Slovenian: Če se interval QTc med zdravljenjem podaljša prek 500 ms, je treba zdravljenje z vemurafenibom začasno prekiniti, odpraviti nepravilnosti elektrolitov (vključno z magnezijem) in obvladati srčne dejavnike tveganja za podaljšanje intervala QT (npr. kongestivno srčno popuščanje, bradiaritmije).
English: Table 3: ADRs occurring in patients treated with vemurafenib in the phase II or phase III study and events originating from safety reports across all trials(1) and post-marketing sources(2).
Slovenian: Preglednica 3: Neželeni učinki, ki so se pojavili pri bolnikih, zdravljenih z vemurafenibom v študiji faze II in III in dogodki iz varnostnih poročil vseh preskušanj(1) in obdobja po prihodu zdravila na trg(2)
English: Cases of sarcoidosis have been reported in patients treated with vemurafenib, mostly involving the skin, lung and eye.
Slovenian: Pri bolnikih, zdravljenih z vemurafenibom, so poročali o primerih sarkoidoze, ki so večinoma vključevali kožo, pljuča in oči.
English: Secondary objectives included an evaluation of the efficacy of vemurafenib using BORR in the brain of previously treated patients, duration of response (DOR), progression-free survival (PFS) and overall survival (OS) in patients with melanoma metastatic to the brain (see table 10).
Slovenian: Sekundarni cilji so vključevali oceno učinkovitosti vemurafeniba glede na BORR v možganih predhodno zdravljenih bolnikov, trajanje odziva (DOR, duration of response), preživetje brez napredovanja bolezni (PFS) in celokupno preživetje (OS) pri bolnikih z melanomom, ki je zaseval v možgane (glejte preglednico 10).
English: In case of vomiting after vemurafenib administration the patient should not take an additional dose of the medicinal product but the treatment should be continued as usual.
Slovenian: Če bolnik po zaužitju vemurafeniba bruha, ne sme vzeti dodatnega odmerka zdravila, ampak mora z zdravljenjem normalno nadaljevati.
English: Number of crossover patients (%)
Slovenian: Število bolnikov, ki je prešlo na vemurafenib (%)
English: Table 10: Efficacy of vemurafenib in patients with brain metastases
Slovenian: Preglednica 10: Učinkovitost vemurafeniba pri bolnikih z zasevki v možganih
English: Concomitant administration of strong CYP3A4 inhibitors or inducers or inhibitors/inducer of transport protein activity may alter vemurafenib concentrations.
Slovenian: Sočasno dajanje močnih zaviralcev/induktorjev CYP3A4 ali zaviralcev/induktorjev aktivnosti prenašalnih beljakovin lahko spremeni koncentracije vemurafeniba.
English: Vemurafenib may increase the plasma exposure of medicinal products that are P-gp substrates.
Slovenian: Vemurafenib lahko poveča plazemsko izpostavljenost zdravilom, ki so substrati P-gp.
English: The co-primary efficacy endpoints of the study were overall survival (OS) and progression-free survival (PFS).
Slovenian: Primarna opazovana dogodka učinkovitosti v študiji sta bila celokupno preživetje (OS, overall survival) in preživetje brez napredovanja bolezni (PFS, progression-free survival).
English: Side effects are listed below by frequency:
Slovenian: Spodaj so glede na pogostnost navedeni neželeni učinki:
English: Dupuytren's contracture and plantar fascial fibromatosis Dupuytren's contracture and plantar fascial fibromatosis have been reported with vemurafenib.
Slovenian: Dupuytrenova kontraktura in fibromatoza plantarne fascije Pri jemanju vemurafeniba so poročali o Dupuytrenovi kontrakturi in fibromatozi plantarne fascije.
English: Vemurafenib has minor influence on the ability to drive and use machines.
Slovenian: Vemurafenib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: ● Cough.
Slovenian: • kašelj.
English: Any suspicious skin lesions should be excised, sent for dermatopathologic evaluation and treated as per local standard of care.
Slovenian: Vsako sumljivo spremembo je treba izrezati, poslati na histopatološko oceno in jo zdraviti v skladu z lokalnimi smernicami.
English: Vemurafenib should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Slovenian: Nosečnice ne smejo prejemati vemurafeniba, razen če možne koristi za mater odtehtajo možna tveganja za plod.
English: Interrupt treatment until grade 0 - 1.
Slovenian: Prekinite zdravljenje, dokler se neželeni dogodek ne zniža na stopnjo 0 do 1.
English: Although metabolism does not appear to result in a relevant amount of metabolites in plasma, the importance of metabolism for excretion cannot be excluded.
Slovenian: Zdi se, da pri presnavljanju ne pride do pomembnih količin presnovkov v plazmi, čeprav pomembnosti presnove pri izločanju ne moremo izključiti.
English: ● Types of skin cancers (basal cell carcinoma, new primary melanoma)
Slovenian: • vrste kožnega raka (bazalnocelični karcinom, novi primarni melanom),
English: Kidney or liver problems
Slovenian: Težave z ledvicami ali jetri
English: Although limited by the low number of patients, efficacy analyses among these patients with V600K-positive tumours suggested similar treatment benefit of vemurafenib in terms of OS, PFS and confirmed best overall response.
Slovenian: Kljub omejenemu številu bolnikov analize učinkovitosti med temi bolniki z V600K pozitivnimi tumorji kažejo dobrobit zdravljenja z vemurafenibom glede na celokupno preživetje, preživetje brez napredovanja bolezni in potrjen najboljši celokupni odziv.
English: Analysis of centralised ECG data from an open-label uncontrolled phase II QT sub-study in 132 patients dosed with vemurafenib 960 mg twice daily (NP22657) showed an exposure-dependent QTc prolongation.
Slovenian: Analiza centraliziranih podatkov o EKG iz podštudije intervala QT v odprti, nekontrolirani študiji faze II pri 132 bolnikih, ki so prejemali 960 mg vemurafeniba dvakrat na dan (NP22657), je pokazala od izpostavljenosti odvisno podaljšanje intervala QTc.
English: Older patients (≥ 65 years) may be more likely to experience adverse reactions, including cuSCC, decreased appetite, and cardiac disorders.
Slovenian: Pri starejših bolnikih (≥ 65 let) je možna večja verjetnost neželenih učinkov, vključno s ploščatoceličnim karcinomom kože, zmanjšanjem teka in motnjami srčnega ritma.
English: Vemurafenib is for oral use.
Slovenian: Vemurafenib je namenjen peroralni uporabi.
English: Women of childbearing potential / Contraception in females Women of childbearing potential have to use effective contraception during treatment and for at least 6 months after treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in vsaj še 6 mesecev po zdravljenju uporabljati učinkovito kontracepcijsko zaščito.
English: ● Change in liver tests results (GGT increase)
Slovenian: • spremembe v izvidih jetrnih testov (zvišanje GGT),
English: - Cohort 1 with previously untreated patients (N = 90): Patients who had not received previous treatment for brain metastases; prior systemic therapy for metastatic melanoma was allowed, excluding BRAF inhibitors and MEK inhibitors.
Slovenian: - 1. skupina: predhodno nezdravljeni bolniki (n = 90) - bolniki, katerih zasevkov v možganih še niso zdravili; predhodno sistemsko zdravljenje metastatskega melanoma brez zaviralcev BRAF in MEK je bilo dovoljeno.
English: (95% CI)d
Slovenian: (95-% IZ)
English: ● Thickening of tissues underneath the palm of the hand which may cause tightening of the fingers inward; it can be disabling if severe
Slovenian: • zadebelitev tkiv pod dlanjo, ki lahko povzroči, da zategnjene prste vleče proti dlani; če je huda,
English: Maintain vemurafenib at a dose of 960 mg twice daily.
Slovenian: Ohranite odmerek vemurafeniba 960 mg dvakrat na dan.
English: Very common ≥ 1/10
Slovenian: Zelo pogosti: ≥ 1/10
English: The overall survival rate at 6 months was 77% (95% CI: 70%, 85%) and at 12 months was 58% (95% CI: 49%,
Slovenian: Delež 6-mesečnega preživetja je bil 77 % (95-% interval zaupanja: 70 %; 85 %), delež 12-mesečnega preživetja pa je bil 58 % (95-% interval zaupanja: 49 %; 67 %).
English: The efficacy and safety of vemurafenib in patients with tumours expressing rare BRAF V600 mutations other than V600E and V600K have not been convincingly established (see section 5.1).
Slovenian: Dokazi o učinkovitosti in varnosti vemurafeniba pri bolnikih s tumorji z izraženo redko BRAF V600 mutacijo, ki ni V600E ali V600K, niso prepričljivi (glejte poglavje 5.1).
English: A risk for increased exposure in patients with severe renal impairment cannot be excluded.
Slovenian: Pri bolnikih s hudo okvaro ledvic tveganja za povečano izpostavljenost ne moremo izključiti.
English: Pinkish white to orange white, oval, biconvex film-coated tablets of approximately 19 mm, with ‘VEM' engraved on one side.
Slovenian: Rožnatobele do oranžnobele, ovalne, bikonveksne filmsko obložene tablete, približno 19 mm v premeru, z oznako VEM, vtisnjeno na eni strani.
English: If you stop taking Zelboraf
Slovenian: Če ste prenehali jemati zdravilo Zelboraf
English: While taking the medicinal product, patients should be advised to wear protective clothing and use a broad spectrum Ultraviolet A (UVA)/Ultraviolet B (UVB) sunscreen and lip balm (Sun Protection Factor ≥ 30) when outdoors to help protect against sunburn.
Slovenian: Bolnikom je treba svetovati, naj med jemanjem zdravila za preprečitev sončnih opeklin nosijo zaščitna oblačila in uporabljajo širokospektralno ultravijolično A (UVA)/ultravijolično B (UVB) sredstvo za sončenje in mazilo za ustnice (zaščitni faktor SPF ≥ 30), kadar so na prostem.
English: Heart disorder
Slovenian: Motnje delovanja srca
English: ● medicines for bacterial infections (e.g. azithromycin, clarithromycin)
Slovenian: • zdravila proti bakterijskim okužbam (npr. azitromicin, klaritromicin),
English: Film-coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Slovenian: Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec rdeči železov oksid (E172)
English: No signs of genotoxicity were identified in in vitro assays (bacterial mutation [AMES Assay], human lymphocyte chromosome aberration) nor in the in vivo rat bone marrow micronucleus test conducted with vemurafenib.
Slovenian: Znakov genotoksičnosti niso ugotovili ne v preizkusih in vitro (bakterijskih mutacij [preizkus AMES], kromosomskih aberacij človeških limfocitov), niti v mikrojedrnem testu kostnega mozga podgan in vivo, opravljenih z vemurafenibom.
English: With a median follow-up of 12.9 months (range, 0.6 to 20.1), the primary endpoint of confirmed best overall response rate (CR + PR) as assessed by an independent review committee (IRC) was 53% (95% CI: 44%, 62%).
Slovenian: Mediana spremljanja je bila 12,9 meseca (razpon: od 0,6 do 20,1 meseca), primarni cilj študije je bil potrjen najboljši celokupni odziv (popolni in delni odziv (CR + PR)) po oceni odbora za neodvisni pregled (ICR, independent review committee); ta delež je znašal 53 % (95-% interval zaupanja: 44 %; 62 %).
English: Nine of the 132 patients enrolled into NP22657 had V600K mutation-positive tumours according to retrospective Sanger sequencing.
Slovenian: Devet od 132 bolnikov, vključenih v študijo NP22657, je imelo tumorje z V600K pozitivno mutacijo glede na retrospektivno določanje zaporedja po metodi Sanger.
English: ● Change in liver tests results (ALT, alkaline phosphatase and bilirubin increase)
Slovenian: • spremembe v izvidih jetrnih testov (zvišanje ALT, alkalne fosfataze in bilirubina),
English: Previous history of cancer
Slovenian: Anamneza raka
English: Progression of pre-existing pancreatic adenocarcinoma with KRAS mutation.
Slovenian: Napredovanje že obstoječega adenokarcinoma trebušne slinavke z mutacijo KRAS.
English: There were no increases to Grade 4 ALT, alkaline phosphatase or bilirubin.
Slovenian: Zvišanja ALT, alkalne fosfataze ali bilirubina do stopnje 4 ni bilo.
English: It is not known whether vemurafenib is excreted in human milk.
Slovenian: Ni znano, ali se vemurafenib izloča v materino mleko.
English: Occasional intake of vemurafenib on an empty stomach is expected to have limited influence on steady state exposure due to the high accumulation of vemurafenib at steady state.
Slovenian: Občasno jemanje vemurafeniba na prazen želodec naj bi imelo majhen vpliv na izpostavljenost v stanju dinamičnega ravnovesja zaradi visoke akumulacije vemurafeniba v stanju dinamičnega ravnovesja.
English: The effect of food on steady state vemurafenib exposure is currently unknown.
Slovenian: Vpliv hrane na izpostavljenost vemurafenibu v stanju dinamičnega ravnovesja trenutno ni znan.
English: Best overall confirmed response rate as assessed by independent review committee, number of responders n (%) b Two-sided 95% Clopper-Pearson Confidence Interval (CI) c Duration of response as assessed by an Independent Review Committee d Kaplan-Meier estimate e Assessed by investigator
Slovenian: d a Delež najboljšega potrjenega celokupnega odziva po oceni odbora za neodvisni pregled, število odzivnih bolnikov n (%) b Dvostranski 95-% Clopper-Pearsonov interval zaupanja (IZ) c Trajanje odziva po oceni odbora za neodvisni pregled d
English: ● Skin problems including warts
Slovenian: • težave s kožo, vključno z bradavicami,
English: Most lesions classified as “other” (43%) were benign skin lesions (e.g. verruca vulgaris, actinic keratosis, benign keratosis, cyst/benign cyst).
Slovenian: Večina sprememb, opredeljenih kot "drugo" (43 %), so bile benigne kožne spremembe (npr. navadna bradavica, aktinična keratoza, benigna keratoza, cista/benigna cista).
English: In addition, patients should undergo a chest Computerised Tomography (CT) scan, prior to treatment and every 6 months during treatment.
Slovenian: Poleg tega morajo bolniki pred zdravljenjem in na 6 mesecev med zdravljenjem opraviti računalniško tomografijo (CT) prsnega koša.
English: Mild induction of CYP2B6 by vemurafenib was noted in vitro at a vemurafenib concentration of 10 µM.
Slovenian: Blaga indukcija CYP2B6 z vemurafenibom je bila opažena in vitro, pri 10 µM koncentraciji vemurafeniba.
English: PFS - overall Median (months)e
Slovenian: PFS - celokupno mediana (meseci)e
English: Stop taking Zelboraf and get medical help immediately if you have any symptoms of an allergic reaction such as swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation.
Slovenian: Prenehajte z jemanjem zdravila Zelboraf in takoj poiščite medicinsko pomoč, če se pri vas pojavi kateri koli od simptomov alergijske reakcije, kot so oteklost obraza, ust ali jezika, težko dihanje, kožni izpuščaj ali omedlevica.
English: The recommended dose of vemurafenib is 960 mg (4 tablets of 240 mg) twice daily (equivalent to a total daily dose of 1,920 mg).
Slovenian: Priporočeni odmerek vemurafeniba je 960 mg (4 tablete po 240 mg) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 1920 mg).
English: Results from the Phase III study (NO25026) in previously untreated patients An open-label, multicentre, international, randomised phase III study supports the use of vemurafenib in previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma.
Slovenian: Rezultati študije faze III (NO25026) pri predhodno nezdravljenih bolnikih Odprta, multicentrična, randomizirana mednarodna študija faze III podpira uporabo vemurafeniba pri predhodno nezdravljenih bolnikih z neresektabilnim ali metastatskim melanomom s pozitivno mutacijo BRAF V600E.
English: There is no information about the safety of Zelboraf in pregnant women.
Slovenian: O varnosti zdravila Zelboraf pri nosečnicah ni podatkov.
English: This can occur on the area that was treated with radiation, such as the skin, esophagus, bladder, liver, rectum, and lungs.
Slovenian: To se lahko pojavi na delu, ki so ga zdravili z obsevanjem, kot je koža, požiralnik, sečni mehur, jetra, danka in pljuča.
English: The pharmacokinetic parameters for vemurafenib were determined using non-compartmental analysis in a phase I and phase III studies (20 patients after 15 days of dosing at 960 mg twice daily, and 204 patients in steady state day 22) as well as by population PK analysis using pooled data from 458 patients.
Slovenian: Farmakokinetične parametre vemurafeniba so določili z nerazdelčno analizo v študijah faze I in faze III (pri 20 bolnikih po 15 dneh odmerjanja 960 mg dvakrat na dan in 204 bolnikih v stanju dinamičnega ravnovesja 22. dan), kot tudi s populacijsko farmakokinetično analizo, v kateri so bili uporabljeni kumulativni podatki 458 bolnikov.
English: Renal toxicity
Slovenian: Ledvična toksičnost