FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack-size: 56 x 1 film-coated tablets (7 blisters of 8 x 1 tablet)
Croatian: Veličina pakiranja: 56 x 1 filmom obložena tableta (7 blistera s 8 x 1 tabletom)
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.
Croatian: Žene reproduktivne dobi / Kontracepcija u žena Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom i najmanje 6 mjeseci nakon liječenja.
English: Grenzach-Wyhlen Germany
Croatian: Grenzach-Wyhlen Njemačka
English: ● If you notice any changes in your skin while taking this medicine, please talk to your doctor as soon as possible.
Croatian: • Ako primijetite bilo kakve promjene na koži dok uzimate ovaj lijek, što prije se obratite liječniku.
English: ● Swelling of the face, lips or tongue
Croatian: • oticanje lica, usana ili jezika
English: (z) As of February 01, 2012, a total of 675 patients were evaluable for the post-hoc analysis update of PFS.
Croatian: (z) Od 1. veljače 2012. je za ažuriranu post-hoc analizu PFS-a bilo dostupno ukupno 675 bolesnika.
English: It is important to keep taking Zelboraf for as long as your doctor prescribes it for you.
Croatian: Važno je da nastavite uzimati Zelboraf onoliko dugo koliko Vam ga liječnik propisuje.
English: The population pharmacokinetic analysis indicated a 17% greater apparent clearance (CL/F) and a 48% greater apparent volume of distribution (V/F) in males than in females.
Croatian: Populacijska farmakokinetička analiza ukazala je na 17% veći prividni klirens (CL/F) i 48% veći prividni volumen raspodjele (V/F) u muškaraca nego u žena.
English: Zelboraf has side effects that can affect your ability to drive or to operate machines.
Croatian: Zelboraf ima nuspojave koje mogu utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor, ATC code: L01XE15
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein-kinaze, ATK oznaka: L01XE15
English: Cohort 2 Previously treated n = 56
Croatian: 2. kohorta Prethodno liječeni n = 56
English: Vemurafenib should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Croatian: Vemurafenib se ne smije primijeniti u trudnica osim ako moguća dobrobit za majku ne nadilazi moguće rizike za fetus.
English: This leaflet was last revised in <{MM/YYYY}> Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: QT prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de Pointes.
Croatian: Produljenje QT-intervala može dovesti do povećanog rizika za ventrikularne aritmije, uključujući Torsade de Pointes.
English: Estimated from 16,403 melanomas with annotated BRAF codon 600 mutations in the public COSMIC database, release 71 (November 2014).
Croatian: Procijenjeno na temelju 16403 melanoma s označenim mutacijama kodona 600 gena BRAF u javnoj bazi podataka COSMIC, izdanje 71 (Studeni 2014.).
English: If you take more Zelboraf than you should
Croatian: Ako uzmete više lijeka Zelboraf nego što ste trebali
English: Based on the population PK analysis, age has no statistically significant effect on vemurafenib pharmacokinetics.
Croatian: Na temelju populacijske farmakokinetičke analize, dob nema statistički značajan utjecaj na farmakokinetiku vemurafeniba.
English: Your doctor will also do some blood tests to check your liver and kidney functions before you start taking Zelboraf and during treatment.
Croatian: Liječnik će provoditi i neke krvne pretrage kako bi provjerio rad jetre i bubrega prije nego što počnete uzimati Zelboraf i tijekom liječenja.
English: ● Allergic reactions that may include swelling of the face and difficulty breathing
Croatian: • alergijske reakcije koje mogu obuhvaćati oticanje lica i otežano disanje
English: • Common: ALT, alkaline phosphatase, bilirubin
Croatian: • Često: ALT, alkalna fosfataza, bilirubin
English: Beware of fatigue or eye problems that could be a reason for not driving.
Croatian: Obratite pozornost na umor ili probleme s očima koji mogu predstavljati razlog da ne upravljate vozilom.
English: ● The active substance is vemurafenib.
Croatian: • Djelatna tvar je vemurafenib.
English: Vemurafenib might decrease the efficacy of hormonal contraceptives (see section 4.5).
Croatian: Vemurafenib može umanjiti djelotvornost hormonskih kontraceptiva (vidjeti dio 4.5).
English: A causal relationship between the medicinal product and the adverse event is at least a reasonable possibility.
Croatian: (3) Uzročna povezanost lijeka s nuspojavom predstavlja barem razumnu mogućnost.
English: ● Regularly during your treatment and up to 6 months after your treatment, your doctor needs to check your skin for a type of cancer called “cutaneous squamous cell carcinoma”.
Croatian: • Redovito tijekom liječenja i do 6 mjeseci nakon završetka liječenja liječnik Vam mora pregledavati kožu zbog moguće pojave jedne vrste raka kože koji se zove "planocelularni karcinom kože".
English: Carefully consider benefits and risks before administering vemurafenib to patients with a prior or concurrent cancer associated with RAS mutation.
Croatian: Pomno razmotrite koristi i rizike prije nego primijenite vemurafenib bolesnicima s prijašnjim ili postojećim karcinomom povezanim s RAS mutacijom.
English: If you are taking any of these medicines (or if you are not sure), please talk to your doctor before taking Zelboraf.
Croatian: Ako uzimate neki od tih lijekova (ili niste sigurni), molimo obratite se svom liječniku prije nego uzmete Zelboraf.
English: The median number of brain target lesions at baseline was 2 (range 1 to 5), in both cohorts.
Croatian: Medijan broja ciljnih moždanih lezija na početku ispitivanja iznosio je 2 (raspon: 1 do 5) u obje kohorte.
English: Unstratified log-rank test for PFS and Chi-squared test for Overall Response Rate.
Croatian: Nestratificirani log-rang test za PFS i hi-kvadrat test za stopu ukupnog odgovora na liječenje.
English: Pinkish white to orange white, oval, biconvex film-coated tablets of approximately 19 mm, with ‘VEM' engraved on one side.
Croatian: Ružičasto-bijele do narančasto-bijele, ovalne, bikonveksne, filmom obložene tablete veličine približno 19 mm, s utisnutom oznakom "VEM" na jednoj strani.
English: However, exposures in the embryofoetal development studies were below the clinical exposure based on AUC comparison, it is therefore difficult to define to what extent these results can be extrapolated to humans.
Croatian: S obzirom da su razine izloženosti u ispitivanjima embriofetalnog razvoja bile niže od izloženosti u kliničkoj primjeni na temelju usporedbe AUC-a, teško je odrediti do koje se mjere ti rezultati mogu ekstrapolirati na ljude.
English: PHARMACEUTICAL FORM AND CONTENTS 56 x 1 film-coated tablets
Croatian: OBLIK I SADRŽAJ 56 x 1 filmom obložena tableta
English: Patients should be closely monitored when re-starting vemurafenib after an episode of pancreatitis.
Croatian: Bolesnici moraju biti pod strogim nadzorom kada ponovo započinju uzimanje vemurafeniba nakon epizode pankreatitisa.
English: Unexplained abdominal pain should be promptly investigated (including measurement of serum amylase and lipase).
Croatian: Neobjašnjiva bol u abdomenu hitno mora biti ispitana (uključujući određivanje vrijednosti serumske amilaze i lipaze).
English: If you get any of these:
Croatian: Ako nastupi nešto od sljedećeg:
English: The safety and efficacy of vemurafenib in children less than 18 years old have not been established.
Croatian: Sigurnost i djelotvornost vemurafeniba u djece mlađe od 18 godina nisu ustanovljene.
English: Non-censored results at time of cross-over: March 31 2011: HR (95% CI) = 0.47 (0.35, 0.62); October 3 2011: HR (95% CI) = 0.67 (0.54, 0.84); February 1 2012: HR (95% CI) = 0.76 (0.63, 0.93); December 20 2012: HR (95% CI) = 0.79 (0.66, 0.95)
Croatian: Cenzurirani rezultati u vrijeme prelaska u drugu skupinu Necenzurirani rezultati u vrijeme prelaska u drugu skupinu: 31. ožujka 2011.: HR (95% CI) = 0,47 (0,35; 0,62); 3 listopada 2011.: HR (95% CI) = 0,67 (0,54; 0,84); 1. veljače 2012.: HR (95% CI) = 0,76 (0,63; 0,93); 20. prosinca 2012.: HR (95% CI) = 0,79 (0,66; 0,95)
English: The in vivo relevance of this finding is unknown, but a risk for a clinically relevant effect on concomitantly administered CYP2C8 substrates cannot be excluded.
Croatian: Nije poznata važnost tog nalaza in vivo, no ne može se isključiti rizik od klinički značajnog učinka na istodobno primijenjene supstrate CYP2C8.
English: Any suspicious skin lesions should be excised, sent for dermatopathologic evaluation and treated as per local standard of care.
Croatian: Svaku sumnjivu kožnu leziju potrebno je kirurški odstraniti, poslati na dermatopatološku analizu i liječiti prema lokalnim standardnim metodama liječenja.
English: At the pre-specified interim analysis with a December 30, 2010 data cut-off, significant improvements in the co-primary endpoints of OS (p<0.0001) and PFS (p<0.0001) (unstratified log-rank test) were observed.
Croatian: U prethodno planiranoj međuanalizi podataka prikupljenih do 30. prosinca 2010. opažena su značajna poboljšanja u obje primarne mjere ishoda: OS (p < 0,0001) i PFS (p < 0,0001) (nestratificirani logrank test).
English: Further monitoring is recommended in particular in patients with moderate to severe hepatic impairment monthly during the first 3 months of treatment followed by every 3 months thereafter or more often as clinically indicated.
Croatian: Dodatne kontrole preporučuju se osobito u bolesnika s umjerenim do teškim oštećenjem jetre, i to svaki mjesec u prva 3 mjeseca liječenja, a zatim svaka 3 mjeseca ili češće ako postoji klinička indikacija.
English: Median overall survival was 15.9 months (95% CI: 11.6, 18.3).
Croatian: Medijan ukupnog preživljenja iznosio je 15,9 mjeseci (95% CI: 11,6; 18,3).
English: No new safety signals were observed in a clinical study with six adolescent patients.
Croatian: U kliničkom ispitivanju sa šest adolescentnih bolesnika nisu primijećeni novi sigurnosni signali.
English: Important information about some of the ingredients of Zelboraf This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Croatian: Važne informacije o nekim sastojcima lijeka Zelboraf Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: Monitoring for skin lesions should occur as outlined in section 4.4.
Croatian: Kontrole kožnih lezija potrebno je provoditi kako je navedeno u dijelu 4.4.
English: (y) As of December 30, 2010, a total of 549 patients were evaluable for PFS and 439 patients were evaluable for overall response rate.
Croatian: Od 30. prosinca 2010. na PFS se moglo analizirati ukupno 549, a na ukupan odgovor na liječenje 439 bolesnika.
English: Based on the criteria for drug induced liver injury developed by an international expert working group of clinicians and scientists, liver injury was defined as any one of the following laboratory abnormalities:
Croatian: Temeljeno na kriterijima za oštećenje tkiva jetre uzrokovano lijekovima koje je ustanovila međunarodna skupina stručnjaka kliničara i znanstvenika, oštećenjem tkiva jetre smatra se bilo koje od navedenih laboratorijskih odstupanja:
English: Figure 1: Kaplan-Meier curves of overall survival - previously untreated patients (December 20, 2012 cut-off)
Croatian: Slika 1: Kaplan-Meierove krivulje ukupnog preživljenja - prethodno neliječeni bolesnici (podaci do zaključno 20. prosinca 2012.)
English: LDH: Lactate Dehydrogenase, ECOG PS: Eastern Cooperative Oncology Group Performance Status
Croatian: LDH: laktatna dehidrogenaza, ECOG PS: opće stanje po ECOG ljestvici (Eastern Cooperative Oncology Group Performance Status), GGN: gornja granica normale
English: Taking your tablets
Croatian: Uzimanje tableta
English: Treatment with vemurafenib should continue until disease progression or the development of unacceptable toxicity (see tables 1 and 2 below).
Croatian: Liječenje vemurafenibom potrebno je nastaviti do progresije bolesti ili do razvoja neprihvatljive toksičnosti (vidjeti tablice 1 i 2 niže u tekstu).
English: LDH >ULN
Croatian: LDH > GGN
English: They are oval with “VEM” engraved on one side.
Croatian: Ovalnog su oblika, s utisnutom oznakom "VEM" na jednoj strani.
English: If a dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen.
Croatian: Ako se doza propusti, može se uzeti do 4 sata prije vremena predviđenog za sljedeću dozu kako bi se održao raspored uzimanja dvaput na dan.
English: ● Tell your doctor if you have kidney or liver problems.
Croatian: • Recite liječniku ako imate tegoba s bubrezima ili jetrom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/751/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/751/001
English: The effects of Zelboraf in people younger than 18 years old are not known.
Croatian: Nisu poznati učinci lijeka Zelboraf u osoba mlađih od 18 godina.
English: Zelboraf targets proteins made from this modified gene and slows down or stops the development of your cancer.
Croatian: Zelboraf ciljano djeluje na proteine koje stvara taj promijenjeni gen te usporava ili zaustavlja napredovanje raka.
English: Forty-nine percent of patients failed ≥ 2 prior therapies.
Croatian: Četrdeset i devet posto bolesnika nije uspješno odgovorilo na ≥ 2 prethodne linije liječenja.
English: • ≥ 3x ULN ALT with simultaneous elevation of bilirubin concentration > 2x ULN
Croatian: • ≥ 3x GGN ALT s istovremenim povećanjem koncentracije bilirubina > 2x GGN
English: The overall survival rate at 6 months was 77% (95% CI: 70%, 85%) and at 12 months was 58% (95% CI: 49%,
Croatian: Stopa ukupnog preživljenja nakon 6 mjeseci bila je 77% (95% CI: 70%, 85%), a nakon 12 mjeseci 58% (95% CI: 49%, 67%).
English: ● Tell your doctor if you have had, or are going to have radiotherapy, as Zelboraf may worsen radiation treatment side effects.
Croatian: • Obavijestite liječnika ako ste primili ili trebate primiti terapiju zračenjem jer Zelboraf može pogoršati nuspojave liječenja zračenjem.
English: Results from the phase I study (NO25390) in paediatric patients
Croatian: Rezultati iz ispitivanja faze I (NO25390) u pedijatrijskih bolesnika
English: INFORMATION IN BRAILLE zelboraf
Croatian: 16. PODACI NA BRAILLEOVOM PISMU zelboraf
English: Patients should be made aware of the potential fatigue or eye problems that could be a reason for not driving.
Croatian: Bolesnicima je potrebno napomenuti da mogući umor ili problemi s očima mogu predstavljati razlog da ne upravljaju vozilom.
English: All terms included are based on the highest percentage observed among phase II and phase III clinical trials.
Croatian: Sve nuspojave uključene su temeljem najvećeg postotka opaženog u kliničkim ispitivanjima faze II ili faze III.
English: ● Film-coating: iron oxide red, macrogol 3350, polyvinyl alcohol, talc and titanium dioxide.
Croatian: • film ovojnica: crveni željezov oksid, makrogol 3350, polivinilni alkohol, talk i titanijev dioksid.
English: ● use a lip balm and a broad spectrum sunscreen (minimum of Sun Protection Factor (SPF) 30, re-applied every 2 to 3 hours).
Croatian: • na usne nanesite balzam, a na kožu sredstvo za zaštitu od sunca širokog spektra (zaštitni faktor najmanje 30, nanositi svaka 2-3 sata).
English: Number of events (%) Median PFS (months) (95% CI)
Croatian: Broj događaja (%) Medijan PFS (mjeseci) (95% CI)
English: Previous history of cancer
Croatian: Rak u povijesti bolesti
English: Most lesions classified as “other” (43%) were benign skin lesions (e.g. verruca vulgaris, actinic keratosis, benign keratosis, cyst/benign cyst).
Croatian: Većina lezija klasificiranih kao "drugo" (43%) bile su benigne lezije kože (npr. verruca vulgaris, aktinička keratoza, benigna keratoza, cista/benigna cista).
English: See monitoring measures in section 4.4.
Croatian: Vidjeti mjere praćenja u dijelu 4.4.
English: Treatment with vemurafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Croatian: Liječenje vemurafenibom mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv karcinoma.
English: • Uncommon: AST
Croatian: • Manje često: AST
English: However, the parent compound was the predominant component (95%) in plasma.
Croatian: Međutim, dominantna sastavnica u plazmi je osnovni spoj (95%).
English: Table 2: Dose modification schedule based on prolongation of the QT interval QTc value
Croatian: Tablica 2: Raspored prilagodbe doze na temelju produljenja QT-intervala QTc-interval
English: Elderly No special dose adjustment is required in patients aged > 65 years old.
Croatian: Nije potrebno posebno prilagođavati dozu bolesnicima starijima od 65 godina.
English: Re-initiation of treatment should occur once the QTc decreases below 500 ms and at a lower dose as described in table 2.
Croatian: Liječenje se može ponovno započeti nakon što QTc-interval padne ispod 500 ms, i to uz nižu dozu, kako je prikazano u tablici 2.
English: ● If it is less than 4 hours before your next dose, skip the missed dose.
Croatian: • Ako je do sljedeće doze ostalo manje od 4 sata, preskočite propuštenu dozu.
English: How to take Zelboraf
Croatian: Kako uzimati Zelboraf
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.
Croatian: Zbog dugog poluvijeka vemurafeniba, potpun inhibitorni učinak vemurafeniba na istodobno primijenjene lijekove možda se neće primijetiti prije 8. dana liječenja vemurafenibom.
English: Zelboraf is an anticancer medicine that contains the active substance vemurafenib.
Croatian: Zelboraf je lijek za liječenje raka koji sadrži djelatnu tvar vemurafenib.
English: There is no specific antidote for overdose of vemurafenib.
Croatian: Nema specifičnog antidota za predoziranje vemurafenibom.
English: Variability in exposure may also occur due to differences in gastro-intestinal fluid content, volumes, pH, motility and transition time and bile composition.
Croatian: Do varijabilnosti u izloženosti može doći uslijed razlika u sadržaju tekućine u gastrointestinalnom traktu, volumenu, pH, motilitetu, vremenu prolaska te u sastavu žuči.
English: In the phase III study, ninety-four (28%) of 336 patients with unresectable or metastatic melanoma treated with vemurafenib were ≥ 65 years.
Croatian: U ispitivanju faze III su 94 od 336 bolesnika (28%) s neresektabilnim ili metastatskim melanomom liječenih vemurafenibom imala 65 ili više godina.
English: In animal studies, vemurafenib was found to cross the placenta.
Croatian: U ispitivanjima na životinjama ustanovljeno je da vemurafenib prolazi kroz placentu.
English: Initiation of treatment with vemurafenib is not recommended in patients with QTc>500 milliseconds (ms).
Croatian: Ne preporučuje se započeti liječenje vemurafenibom u bolesnika koji imaju QTc > 500 milisekundi (ms).
English: At steady state, the mean vemurafenib exposure in plasma is stable during the 24-hour interval as indicated by the mean ratio of 1.13 between the plasma concentrations before and 2-4 hours after the morning dose.
Croatian: U stanju dinamičke ravnoteže prosječna je izloženost vemurafenibu u plazmi stabilna tijekom 24-satnog razdoblja, što pokazuje srednji omjer od 1,13 između koncentracija u plazmi prije te 2-4 sata nakon jutarnje doze.
English: In a phase III clinical trial (MO25515, N= 3219), a higher incidence of potentiation of radiation toxicity was reported when vemurafenib patients received radiation prior to and during vemurafenib therapy (9.1%) compared to those patients who received radiation and vemurafenib concomitantly (5.2 %) or to those whose radiation treatment was prior to vemurafenib (1.5%).
Croatian: U kliničkom ispitivanju faze III (MO25515, N= 3219) veća incidencija pojačavanja radijacijske toksičnosti prijavljena je kada su bolesnici liječeni vemurafenibom primali radioterapiju prije i tijekom liječenja vemurafenibom (9,1%) nego u bolesnika koji su radioterapiju i vemurafenib primali istodobno (5,2%) ili u onih koji su liječeni radioterapijom prije primjene vemurafeniba (1,5%).
English: ● Inflammatory disease mainly affecting the skin, lung and eye (sarcoidosis)
Croatian: • upalna bolest koja uglavnom zahvaća kožu, pluća i oko (sarkoidoza)
English: It was designed to detect the predominant BRAF V600E mutation with high sensitivity (down to 5% V600E sequence in a background of wild type sequence from FFPE-derived DNA).
Croatian: Osmišljen je tako da s visokom osjetljivošću otkrije predominantnu BRAF mutaciju V600E (do 5% sekvence V600E u pozadini sekvence divljeg tipa iz DNK dobivene iz FFPE).
English: ● Swelling usually in the legs (peripheral oedema)
Croatian: • oticanje, obično nogu (periferni edem)
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).
Croatian: Prosječan učinak na QTc-interval ostao je stabilan između 12-15 ms nakon prvog mjeseca liječenja, a najveće prosječno produljenje QTc-intervala (15,1 ms; gornja granica 95%-tnog CI: 17,7 ms) opaženo je unutar prvih 6 mjeseci (n=90 bolesnika).
English: For patients treated with stereotactic radiotherapy (SRT) or surgery, a new RECIST-assessable brain lesion must have developed following this prior therapy.
Croatian: Bolesnici liječeni stereotaktičkom radioterapijom (SRT) ili kirurškim zahvatom morali su imati novu moždanu leziju mjerljivu prema RECIST kriterijima, koja se razvila nakon te prethodne terapije.
English: They are available in aluminium perforated unit dose blisters in packs of 56 x 1 tablets.
Croatian: Dostupne su u aluminijskom perforiranom blister pakiranju djeljivom na jedinične doze, u veličini pakiranja od 56 x 1 tablete.
English: The efficacy of vemurafenib has been evaluated in 336 patients from a phase III clinical trial (NO25026) and 278 patients from two phase II clinical trials (NP22657 and MO25743).
Croatian: Djelotvornost vemurafeniba procijenjena je u 336 bolesnika u kliničkom ispitivanju faze III (NO25026) i u 278 bolesnika u dvama kliničkim ispitivanjima faze II (NP22657 i MO25743).
English: ● A medicine used to prevent blood clots called warfarin
Croatian: • Lijek za sprječavanje stvaranja krvnih ugrušaka pod nazivom varfarin.
English: Dermatologic reactions
Croatian: Dermatološke reakcije
English: The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE).
Croatian: Intenzitet kliničkih nuspojava stupnjevan prema Zajedničkim terminološkim kriterijima za nuspojave (Common Terminology Criteria for Adverse Events, verzija 4.0, CTC-AE).
English: Food (high fat meal) increases the relative bioavailability of a single 960 mg dose of vemurafenib.
Croatian: Hrana (punomastan obrok) povećava relativnu bioraspoloživost jedne doze od 960 mg vemurafeniba.
English: ● Difficulty breathing
Croatian: • otežano disanje
English: Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000
Croatian: Za određivanje učestalosti korištene su sljedeće kategorije: vrlo često ≥ 1/10 često ≥ 1/100 i < 1/10 manje često ≥ 1/1000 i < 1/100 rijetko ≥ 1/10 000 i < 1/1000 vrlo rijetko < 1/10 000
English: It is currently unknown whether vemurafenib at a plasma level of 100 µM observed in patients at steady state (approximately 50 µg/ml) may decrease plasma concentrations of concomitantly administered CYP2B6 substrates, such as bupropion.
Croatian: Zasad nije poznato može li vemurafenib u koncentraciji od 100 µm, kakva je opažena u plazmi bolesnika u stanju dinamičke ravnoteže (približno 50 µg/ml), sniziti plazmatske koncentracije istodobno primijenjenih supstrata CYP2B6, primjerice bupropiona.