FrancophonIA/ELRC3.0 huggingface dataset:
English: Vemurafenib revealed no evidence of teratogenicity in rat or rabbit embryo/foetuses (see section 5.3).
Croatian: Vemurafenib nije pokazao znakove teratogenosti u embrija/fetusa štakora i kunića (vidjeti dio 5.3).
English: Tell your doctor immediately if you get eye pain, swelling, redness, blurred vision or other vision changes during your treatment.
Croatian: Odmah obavijestite liječnika ako se tijekom liječenja pojave bol, oticanje ili crvenilo očiju, zamagljen vid ili druge promjene vida.
English: The effects of vemurafenib on medicinal products that are substrates of BCRP are unknown.
Croatian: Nisu poznati učinci vemurafeniba na lijekove koji su supstrati BCRP-a.
English: ● A type of severe skin reaction characterised by rash accompanied by fever and inflammation of internal organs such as liver and kidney
Croatian: • vrsta teške kožne reakcije koju karakterizira osip praćen vrućicom i upalom unutarnjih organa,
English: Concomitant administration of strong CYP3A4 inhibitors or inducers or inhibitors/inducer of transport protein activity may alter vemurafenib concentrations.
Croatian: Istodobna primjena snažnih inhibitora ili induktora CYP3A4 odnosno inhibitora/induktora aktivnosti transportnih proteina može promijeniti koncentracije vemurafeniba.
English: • To grade 4
Croatian: • do 4. stupnja
English: Carcinogenicity studies have not been conducted with vemurafenib.
Croatian: Nisu provedena ispitivanja kancerogenosti vemurafeniba.
English: Data are insufficient to determine the effect of metabolic or excretory hepatic impairment on vemurafenib pharmacokinetics (see sections 4.2 and
Croatian: Podaci nisu dovoljni da bi se odredio učinak oštećenja metaboličke ili ekskretorne funkcije jetre na farmakokinetiku vemurafeniba (vidjeti dijelove 4.2 i 4.4).
English: The effect of food on steady state vemurafenib exposure is currently unknown.
Croatian: Učinak hrane na izloženost vemurafenibu u stanju dinamičke ravnoteže za sada nije poznat.
English: Patients who develop adverse reactions should receive appropriate symptomatic treatment.
Croatian: Bolesnici koji razviju nuspojave moraju primiti odgovarajuću simptomatsku terapiju.
English: The majority of patients was male (61%), Caucasian (99%), and had stage M1c disease (61%).
Croatian: Većina je bolesnika bila muškog spola (61%) i bijele rase (99%) te imala stadij bolesti M1c (61%).
English: Do not use Zelboraf after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Zelboraf se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“/ „EXP“.
English: A total of 675 patients were randomised to vemurafenib (n=337) or dacarbazine (n=338).
Croatian: Randomizirano je ukupno 675 bolesnika, u skupinu liječenu vemurafenibom (n=337) ili u skupinu liječenu dakarbazinom (n=338).
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.
Croatian: Prestanite uzimati Zelboraf i odmah potražite liječničku pomoć ako imate bilo koji simptom alergijske reakcije poput oticanja lica, usana ili jezika, otežanog disanja, osipa ili osjećaja da ćete se onesvijestiti.
English: BRAFV600G BRAFV600M BRAFV600A
Croatian: V600D BRAFV600G
English: ● medicines for bacterial infections (e.g. azithromycin, clarithromycin)
Croatian: • lijekove za liječenje bakterijskih infekcija (npr. azitromicin, klaritromicin)
English: Cases of sarcoidosis have been reported in patients treated with vemurafenib, mostly involving the skin, lung and eye.
Croatian: U bolesnika liječenih vemurafenibom prijavljeni su slučajevi sarkoidoze koja je uglavnom zahvaćala kožu, pluća i oko.
English: • Problem with the nerves that can produce pain, loss of sensation and/or muscle weakness
Croatian: • tegobe sa živcima koje mogu izazvati bol, gubitak osjeta i/ili mišićnu slabost (periferna neuropatija)
English: New primary melanomas have been reported in clinical trials.
Croatian: U kliničkim su ispitivanjima zabilježeni slučajevi novih primarnih melanoma.
English: * Includes acute kidney injury, renal impairment, and laboratory changes consistent with acute kidney injury.
Croatian: * Uključuju akutno oštećenje tkiva bubrega, oštećenje bubrežne funkcije i promjene laboratorijskih nalaza koje odgovaraju akutnom oštećenju tkiva bubrega.
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.
Croatian: • Ako zaboravite uzeti dozu lijeka, a do sljedeće je doze preostalo više od 4 sata, uzmite dozu čim se sjetite.
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).
Croatian: Preporučena doza vemurafeniba je 960 mg (4 tablete od 240 mg) dvaput na dan (što odgovara ukupnoj dnevnoj dozi od 1920 mg).
English: Dose modified for acute kidney injury
Croatian: Prilagodba doze zbog akutnog oštećenja tkiva bubrega
English: Posology adjustments resulting in a dose below 480 mg twice daily are not recommended.
Croatian: Ne preporučuju se prilagodbe doziranja koje bi rezultirale dozom manjom od 480 mg dvaput na dan.
English: Co-administration of itraconazole, a strong CYP3A4/Pgp inhibitor, increased steady state vemurafenib AUC by approximately 40%.
Croatian: Istodobna primjena itrakonazola, snažnog inhibitora CYP3A4/P-gp-a, povećala je AUC vemurafeniba u stanju dinamičke ravnoteže za približno 40%.
English: After cessation of vemurafenib treatment, a washout of 8 days might be necessary to avoid an interaction with a subsequent treatment.
Croatian: Nakon prestanka liječenja vemurafenibom moglo bi biti potrebno osmodnevno razdoblje ispiranja kako bi se izbjegle interakcije sa sljedećim liječenjem.
English: The incidence of cuSCC in vemurafenib-treated patients across studies was approximately 20%.
Croatian: Incidencija planocelularnog karcinoma kože u bolesnika liječenih vemurafenibom kroz sva je ispitivanja bila približno 20%.
English: Potentiation of radiation toxicity
Croatian: Pojačavanje radijacijske toksičnosti
English: In case of suspected overdose, vemurafenib should be withheld and supportive care initiated.
Croatian: U slučaju sumnje na predoziranje potrebno je prekinuti primjenu vemurafeniba i uvesti potporno liječenje.
English: Caution should be used when administering Vemurafenib with strong CYP3A4/PgP inhibitors.
Croatian: Potreban je oprez kada se vemurafenib primjenjuje sa snažnim inhibitorima CYP3A4/P-gp-a.
English: Cases reported include recall phenomenon, radiation skin injury, radiation pneumonitis, radiation esophagitis, radiation proctitis, radiation hepatitis, cystitis radiation, and radiation necrosis.
Croatian: Prijavljeni slučajevi uključuju fenomen upalne reakcije na ozračenom mjestu, ozljedu kože uzrokovanu zračenjem, radijacijski pneumonitis, radijacijski ezofagitis, radijacijski proktitis, radijacijski hepatitis, radijacijski cistitis i radijacijsku nekrozu.
English: Stop taking Zelboraf and talk to your doctor immediately if you get a skin rash with any of the following symptoms: blisters on your skin, blisters or sores in your mouth, peeling of your skin, fever, redness or swelling of your face, hands, or soles of your feet.
Croatian: Prestanite uzimati Zelboraf i odmah se obratite liječniku ako dobijete osip kože s bilo kojim od sljedećih simptoma: mjehurići na koži, mjehurići ili afte u ustima, ljuštenje kože, vrućica, crvenilo ili oticanje lica, šaka ili tabana.
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).
Croatian: Sekundarne mjere ishoda uključivale su ocjenjivanje djelotvornosti vemurafeniba na temelju BORR-a u mozgu prethodno liječenih bolesnika, trajanje odgovora, preživljenje bez progresije bolesti (engl. progression-free survival, PFS) i ukupno preživljenje (engl. overall survival, OS) u bolesnika s melanomom koji je metastazirao u mozak (vidjeti tablicu 10).
English: Of the patients who experienced cuSCC, approximately 33% experienced > 1 occurrence with median time between occurrences of 6 weeks.
Croatian: Približno 33% bolesnika u kojih se razvio planocelularni karcinom kože imalo je > 1 pojave, a medijan vremena između pojava bio je 6 tjedana.
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.
Croatian: Iako ograničene malim brojem bolesnika, analize djelotvornosti u tih bolesnika s tumorom s pozitivnom mutacijom V600K su ukazale na podjednaku korist od liječenja vemurafenibom glede ukupnog preživljenja, preživljenja bez progresije bolesti i potvrđenog najboljeg ukupnog odgovora na liječenje.
English: Serum creatinine should be measured before initiation of treatment and monitored during treatment as clinically indicated (see sections 4.2 and 4.8).
Croatian: Potrebno je odrediti vrijednost kreatinina u serumu prije početka liječenja i kontrolirati ga tijekom liječenja sukladno kliničkoj indikaciji (vidjeti dijelove 4.2 i 4.8).
English: This inhibitory effect was confirmed in the ERK phosphorylation and cellular anti-proliferation assays in available melanoma cell lines expressing V600-mutant BRAF.
Croatian: Ovaj inhibitorni učinak potvrđen je u testovima ERK-fosforilacije i stanične antiproliferacije u dostupnim staničnim linijama melanoma koje izražavaju BRAF s mutacijom V600.
English: Monitoring should continue for 6 months following discontinuation of vemurafenib or until initiation of another anti-neoplastic therapy.
Croatian: Nadzor je potrebno provoditi tijekom 6 mjeseci nakon prestanka liječenja vemurafenibom ili do započinjanja terapije nekim drugim lijekom za liječenje novotvorina.
English: Resume dosing at 480 mg twice daily (or discontinue permanently if the dose has already been lowered to 480 mg twice daily).
Croatian: Nastaviti liječenje dozom od 480 mg dvaput na dan (ili trajno obustaviti liječenje ako je doza već smanjena na 480 mg dvaput na dan).
English: Table 6: Kinase inhibitory activity of vemurafenib against different BRAF kinases Kinase
Croatian: Tablica 6: Inhibitorna aktivnost vemurafeniba na različite BRAF kinaze
English: 7th nerve paralysis, neuropathy peripheral
Croatian: Poremećaji živčanog sustava glavobolja, disgeuzija, omaglica paraliza 7. živca, periferna neuropatija
English: Conjugation metabolites (glucuronidation and glycosylation) were also identified in humans.
Croatian: U ljudi su pronađeni i metaboliti konjugacije (glukuronidacije i glikolizacije).
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.
Croatian: Očekuje se da će povremeno uzimanje vemurafeniba natašte imati ograničen utjecaj na izloženost u stanju dinamičke ravnoteže zbog velike kumulacije vemurafeniba u stanju dinamičke ravnoteže.
English: In the phase II study, AUC0-8h and Cmax at day 1 were 22.1 ± 12.7 µg⋅h/mL and 4.1 ± 2.3 µg/mL.
Croatian: U ispitivanju faze II, AUC0-8h je prvoga dana primjene iznosio 22,1 ± 12,7 µg⋅h/ml, a Cmax 4,1 ± 2,3 µg/ml.
English: ● Feeling tired (fatigue)
Croatian: • osjećaj umora (izmorenost)
English: Concomitant administration of CYP2C8 substrates with a narrow therapeutic window should be made with caution since vemurafenib may increase their concentrations.
Croatian: Potreban je oprez kod istodobne primjene supstrata CYP2C8 s uskom terapijskom širinom jer vemurafenib može povisiti njihove koncentracije.
English: A clinical drug interaction study demonstrated that multiple oral doses of vemurafenib (960 mg twice daily) increased the exposure of a single oral dose of the P-gp substrate digoxin, approximately 1.8 and 1.5 fold for digoxin AUClast and Cmax, respectively.
Croatian: U kliničkom ispitivanju interakcije između lijekova pokazalo se da su višestruke oralne doze vemurafeniba (960 mg dvaput na dan) povećale izloženost digoksinu, supstratu P-gp-a, nakon primjene jednokratne oralne doze, i to AUClast digoksina približno 1,8 puta, a Cmax približno 1,5 puta.
English: Therefore an effect of vemurafenib on the foetus cannot be excluded.
Croatian: Stoga se ne može isključiti mogućnost da vemurafenib utječe na fetus.
English: Events should be managed with dose reduction with treatment interruption or with treatment discontinuation (see section 4.2).
Croatian: Te događaje treba zbrinuti smanjivanjem doze uz privremen prekid liječenja ili trajnim prekidom liječenja (vidjeti dio 4.2).
English: Cases of cuSCC were typically managed with simple excision, and patients generally continued on treatment without dose modification (see sections 4.2 and 4.4).
Croatian: Slučajevi planocelularnog karcinoma standardno su liječeni jednostavnom ekscizijom, a bolesnici su općenito nastavili liječenje bez promjene doze (vidjeti dijelove 4.2 i 4.4).
English: ● Sunburn, being more sensitive to sunlight
Croatian: • sunčane opekline, povećana osjetljivost na sunce
English: Dose adjustments for CYP3A4 substrates with narrow therapeutic window may be considered, if clinically indicated (see sections 4.4 and 4.6).
Croatian: Može se razmotriti prilagodba doze supstrata CYP3A4 s uskom terapijskom širinom, ako je to klinički indicirano (vidjeti dijelove 4.4 i 4.6).
English: Preclinical data generated in biochemical assays demonstrated that vemurafenib can potently inhibit BRAF kinases with activating codon 600 mutations (table 6).
Croatian: Neklinički podaci dobiveni u biokemijskim testovima pokazali su da vemurafenib može snažno inhibirati BRAF kinaze s aktivirajućim mutacijama kodona 600 (Tablica 6).
English: This can occur on the area that was treated with radiation, such as the skin, esophagus, bladder, liver, rectum, and lungs.
Croatian: To se može dogoditi u područjima koja su bila zračena, poput kože, jednjaka, mokraćnog mjehura, jetre, rektuma i pluća.
English: Dupuytren's contracture and plantar fascial fibromatosis Dupuytren's contracture and plantar fascial fibromatosis have been reported with vemurafenib.
Croatian: Dupuytrenova kontraktura i plantarna fascijalna fibromatoza Kod primjene vemurafeniba prijavljene su Dupuytrenova kontraktura i plantarna fascijalna fibromatoza.
English: Vemurafenib should be used with caution in patients with severe renal impairment and patients should be closely monitored.
Croatian: Vemurafenib je potrebno primjenjivati uz oprez u bolesnika s teškim oštećenjem bubrežne funkcije i takve bolesnike treba pomno nadzirati.
English: In patients who experience severe hypersensitivity reactions, vemurafenib treatment should be permanently discontinued (see section 4.4).
Croatian: U bolesnika koji razviju teške reakcije preosjetljivosti treba trajno obustaviti liječenje vemurafenibom (vidjeti dio 4.4).
English: Dose reduction of the concomitant CYP1A2 substrate drug may be considered, if clinically indicated.
Croatian: Može se razmotriti sniženje doze istodobno primijenjenog lijeka koji je supstrat CYP1A2, ako je to klinički indicirano.
English: On this basis, the efficacy of contraceptive pills metabolized by CYP3A4 used concomitantly with vemurafenib might be decreased.
Croatian: Na temelju navedenoga, djelotvornost kontracepcijskih tableta koje se metaboliziraju putem CYP3A4 može biti smanjena kada se uzimaju istodobno s vemurafenibom.
English: Vemurafenib should not be used in patients with wild type BRAF malignant melanoma.
Croatian: Vemurafenib se ne smije primjenjivati u bolesnika koji imaju maligni melanom s divljim tipom BRAF gena.
English: Co-administration of vemurafenib increased the plasma exposure (AUC) of caffeine (CYP1A2 substrate) 2.6-fold.
Croatian: Istodobna primjena vemurafeniba povećala je plazmatsku izloženost (AUC) kofeinu (supstratu CYP1A2) 2,6 puta.
English: Treatment with vemurafenib is not recommended in patients with uncorrectable electrolyte abnormalities (including magnesium), long QT syndrome or who are taking medicinal products known to prolong the QT interval.
Croatian: Ne preporučuje se liječenje vemurafenibom u bolesnika s nepopravljivim poremećajima elektrolita (uključujući magnezij), sindromom produljenog QT-intervala te u onih koji uzimaju lijekove za koje je poznato da produljuju QT-interval.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE PERFORATED BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PERFORIRANI BLISTER DJELJIV NA JEDINIČNE DOZE
English: Abnormal findings should be managed according to clinical practices.
Croatian: Svako odstupanje od normalnih nalaza treba liječiti sukladno kliničkoj praksi.
English: In the population pharmacokinetic analysis using data from clinical trials in patients with metastatic melanoma, increases in AST and ALT up to three times the upper limit of normal did not influence the apparent clearance of vemurafenib.
Croatian: U populacijskoj farmakokinetičkoj analizi u kojoj su korišteni podaci iz kliničkih ispitivanja u bolesnika s metastatskim melanomom, porast vrijednosti AST-a i ALT-a do tri puta iznad gornje granice normalnih vrijednosti nije utjecao na prividni klirens vemurafeniba.
English: Other malignancies
Croatian: Druge zloćudne bolesti
English: Concurrent administration with ipilimumab
Croatian: Istodobna primjena s ipilimumabom
English: Table 8: Overall survival in previously untreated patients with BRAF V600 mutation-positive melanoma by LDH, tumour stage and ECOG status (post hoc analysis, December 20, 2012 cutoff, censored results at time of cross over)
Croatian: Tablica 8: Ukupno preživljenje u prethodno neliječenih bolesnika s melanomom s pozitivnom BRAF mutacijom V600 prema LDH, stadiju tumora i ECOG statusu (post-hoc analiza, podaci do zaključno 20. prosinca 2012., cenzurirani rezultati u vrijeme prelaska)
English: There are no data in patients with severe renal impairment (see sections 4.2 and 4.4).
Croatian: Nema podataka za bolesnike s teškim oštećenjem bubrežne funkcije (vidjeti dijelove 4.2 i 4.4).
English: Effects of vemurafenib on Drug Metabolizing Enzymes Results from an in vivo drug-drug interaction study in metastatic melanoma patients demonstrated that vemurafenib is a moderate CYP1A2 inhibitor and a CYP3A4 inducer.
Croatian: Učinci vemurafeniba na enzime koji metaboliziraju lijekove Rezultati ispitivanja interakcija između lijekova in vivo u bolesnika s metastatskim melanomom pokazali su da je vemurafenib umjeren inhibitor CYP1A2 i induktor CYP3A4.
English: In the event the patient develops Cutaneous Squamous Cell Carcinoma (cuSCC), it is recommended to continue the treatment without modifying the dose of vemurafenib (see sections 4.4 and 4.8).
Croatian: U slučaju da se u bolesnika razvije planocelularni karcinom kože, preporučuje se nastaviti s liječenjem bez prilagodbe doze vemurafeniba (vidjeti dijelove 4.4 i 4.8).
English: No data are available in patients with melanoma harbouring rare BRAF V600 mutations other than V600E and V600K.
Croatian: Nema dostupnih podataka o bolesnicima s melanomom s rijetkom BRAF mutacijom V600, a koja nije V600E ili V600K.
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).
Croatian: Tablica 3: Nuspojave zabilježene u bolesnika liječenih vemurafenibom u ispitivanju faze II ili faze III i događaji koji potječu iz izvješća o sigurnosti primjene iz svih ispitivanja i izvora nakon stavljanja lijeka u promet Klasifikacija organskih sustava
English: Repeat-dose toxicology studies identified the liver and bone marrow as target organs in the dog.
Croatian: Ispitivanja toksičnosti ponovljenih doza pokazala su da su u pasa ciljni organi jetra i koštana srž.
English: EXPIRY DATE
Croatian: Zaključni datumi
English: Mild induction of CYP2B6 by vemurafenib was noted in vitro at a vemurafenib concentration of 10 µM.
Croatian: Opažena je blaga indukcija CYP2B6 vemurafenibom in vitro pri koncentraciji vemurafeniba od 10 µm.
English: ● Tingling or burning feelings in hands and feet
Croatian: • trnci ili žarenje u šakama i stopalima
English: The most common (≥ 5%) Grade 3 ADRs were cuSCC, keratoacanthoma, rash, arthralgia and gamma-glutamyltransferase (GGT) increased.
Croatian: Najčešće nuspojave 3. stupnja (≥ 5%) bile su planocelularni karcinom kože, keratoakantom, osip, artralgija i povišena razina gama-glutamiltransferaze (GGT).
English: ● medicines for nausea and vomiting (e.g. ondansetron, domperidone).
Croatian: • lijekove za liječenje mučnine i povraćanja (npr. ondansetron, domperidon).
English: It cannot be excluded that vemurafenib may increase the exposure of medicines transported by BCRP (e.g. methotrexate, mitoxantrone, rosuvastatin).
Croatian: Ne može se isključiti mogućnost da vemurafenib poveća izloženost lijekovima koji se prenose pomoću BCRP-a (npr. metotreksatu, mitoksantronu, rosuvastatinu).
English: Progression of pre-existing chronic myelomonocytic leukaemia with NRAS mutation.
Croatian: Progresija postojeće kronične mijelomonocitne leukemije s mutacijom gena NRAS.
English: Severe dermatologic reactions have been reported in patients receiving vemurafenib, including rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis in the pivotal clinical trial.
Croatian: U bolesnika liječenih vemurafenibom zabilježene su teške kožne reakcije, uključujući rijetke slučajeve Stevens-Johnsonovog sindroma i toksične epidermalne nekrolize u pivotalnim kliničkim ispitivanjima.
English: In the human mass balance study with vemurafenib administered orally, on average 95% of the dose was recovered within 18 days.
Croatian: U ispitivanju masene bilance u ljudi, kod peroralne se primjene vemurafeniba prosječno 95% doze ustanovi unutar 18 dana.
English: Accumulation occurs upon multiple twice daily dosing of vemurafenib.
Croatian: Nakon višestrukog doziranja dvaput na dan dolazi do nakupljanja vemurafeniba.
English: ● Difficulty or pain when swallowing, chest pain, heartburn or acid reflux (esophagitis).
Croatian: ● otežano gutanje ili bol prilikom gutanja, bol u prsištu, žgaravicu ili povrat kiseline (ezofagitis).
English: In another clinical trial, vemurafenib increased Cmax and AUC of a single 2 mg dose of tizanidine (CYP1A2 substrate) approximately 2.2-fold and 4.7-fold, respectively.
Croatian: U drugom kliničkom ispitivanju vemurafenib je povećao Cmax i AUC jednokratne doze od 2 mg tizanidina (supstrata CYP1A2) približno 2,2 puta odnosno 4,7 puta.
English: Cases of renal toxicity have been reported with vemurafenib ranging from creatinine elevations to acute interstitial nephritis and acute tubular necrosis, some observed in the setting of dehydration events.
Croatian: Kod primjene vemurafeniba prijavljeni su slučajevi toksičnosti za bubrege, koji su se kretali od povišenih vrijednosti kreatinina do akutnog intersticijskog nefritisa i akutne tubularne nekroze; neki od njih primijećeni su u uvjetima dehidracije.
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.
Croatian: Farmakokinetički parametri za vemurafenib utvrđeni su pomoću nekompartmentalne analize u ispitivanjima faze I i faze III (u 20 bolesnika nakon 15 dana primjene doze od 960 mg dvaput na dan i 204 bolesnika u stanju dinamičke ravnoteže 22. dana) kao i populacijske farmakokinetičke analize koristeći zbirne podatke za 458 bolesnika, od kojih je 457 bilo bijele rase.
English: The majority of cases were mild to moderate, but severe, disabling cases of Dupuytren's contracture have also been reported (see section 4.8).
Croatian: Većina slučajeva bila je 1. ili 2. stupnja težine, no prijavljeni su i teški, onesposobljavajući slučajevi Dupuytrenove kontrakture (vidjeti dio 4.8).
English: V600D
Croatian: V600M