FrancophonIA/ELRC3.0 huggingface dataset:
English: 2nd occurrence of any grade 2 or 3 AE or persistence after treatment interruption
Croatian: Drugi nastup bilo koje nuspojave stupnja 2 ili 3, ili trajanje nuspojave nakon prekida liječenja
English: Diarrhoea, vomiting, nausea, constipation
Croatian: Poremećaji probavnog sustava dijareja, povraćanje, mučnina, konstipacija pankreatitis
English: In a Phase I trial, asymptomatic grade 3 increases in transaminases (ALT/AST >5 x ULN) and bilirubin (total bilirubin >3x ULN) were reported with concurrent administration of ipilimumab (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID).
Croatian: U ispitivanju faze I su prilikom istodobne primjene ipilimumaba (3 mg/kg) i vemurafeniba (960 mg BID ili 720 mg BID) prijavljeni asimptomatski porast transaminaza (ALT/AST >5 x GGN) i bilirubina (ukupni bilirubin >3x GGN) stupnja 3. Temeljem ovih preliminarnih podataka, istodobna primjena ipilimumaba i vemurafeniba se ne preporučuje.
English: Table 9 shows the overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma.
Croatian: Tablica 9 prikazuje stopu ukupnog odgovora na liječenje i preživljenje bez progresije bolesti u prethodno neliječenih bolesnika s melanomom s pozitivnom BRAF mutacijom V600.
English: Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test (see sections 4.4 and 5.1).
Croatian: Prije primjene vemurafeniba kod bolesnika se validiranim testom mora potvrditi da je tumor pozitivan na mutaciju BRAF V600 (vidjeti dijelove 4.4 i 5.1).
English: Zelboraf 240 mg film-coated tablets vemurafenib
Croatian: Zelboraf 240 mg filmom obložene tablete vemurafenib
English: ● Medicines that influence a protein called P-gp or BCRP (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole, gefitinib).
Croatian: • Lijekove koji djeluju na protein pod nazivom P-gp ili BCRP (npr. verapamil, ciklosporin, ritonavir, kinidin, itrakonazol, gefitinib).
English: A phase II single-arm, multi-centre, multinational study was conducted in 132 patients who had BRAF V600E mutation-positive metastatic melanoma according to the cobas 4800 BRAF V600 Mutation Test and had received at least one prior therapy.
Croatian: Multicentrično, multinacionalno ispitivanje faze II s jednom skupinom bolesnika provedeno je na 132 bolesnika koji su imali metastatski melanom s pozitivnom BRAF mutacijom V600E potvrđenom testom cobas 4800 BRAF V600 Mutation Test, a koji su prethodno primili barem jednu liniju liječenja.
English: Concomitant administration of strong inducers of P-gp, glucuronidation, and/or CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort [Hypericum perforatum]) may lead to suboptimal exposure to vemurafenib and should be avoided.
Croatian: Istodobna primjena snažnih induktora P-glikoproteina, glukuronidacije i/ili CYP3A4 (npr. rifampicina, rifabutina, karbamazepina, fenitoina ili gospine trave [Hypericum perforatum]) može dovesti do suboptimalne izloženosti vemurafenibu i treba ju izbjegavati.
English: ● Tablet core: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate
Croatian: • jezgra tablete: koloidni bezvodni silicijev dioksid, umrežena karmelozanatrij, hidroksipropilceluloza i magnezijev stearat.
English: Radiation treatment
Croatian: Radioterapija
English: ● Thickening of deep tissues underneath the sole of the feet that may be disabling if severe
Croatian: • zadebljanje dubinskog tkiva ispod tabana koje u teškim slučajevima može uzrokovati onesposobljenost
English: Vemurafenib should be used with caution in combination with strong inhibitors of CYP3A4, glucuronidation and/or transport proteins (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir).
Croatian: Vemurafenib je potrebno primjenjivati uz oprez u kombinaciji sa snažnim inhibitorima CYP3A4, glukuronidacije i/ili transportnih proteina (npr. ritonavirom, sakvinavirom, telitromicinom, ketokonazolom, itrakonazolom, vorikonazolom, posakonazolom, nefazodonom, atazanavirom.
English: Serious ophthalmologic reactions, including uveitis, iritis and retinal vein occlusion, have been reported.
Croatian: Zabilježene su teške oftalmološke reakcije, uključujući uveitis, iritis i okluziju vene mrežnice.
English: Side effects are listed below by frequency:
Croatian: Nuspojave su u daljnjem tekstu navedene prema učestalosti pojavljivanja:
English: No teratogenicity was observed in embryofoetal development studies in rats and rabbits at doses up to respectively 250 mg/kg/day and 450 mg/kg/day leading to exposures below the anticipated clinical exposure (based on AUC comparison).
Croatian: U ispitivanjima embriofetalnog razvoja nije uočena teratogenost pri dozama do 250 mg/kg na dan u štakora, odnosno do 450 mg/kg na dan u kunića, kojima se postigla izloženost manja od izloženosti očekivane u kliničkoj primjeni (na temelju usporedbe AUC-a).
English: NAME OF THE MEDICINAL PRODUCT Zelboraf 240 mg film-coated tablets.
Croatian: NAZIV LIJEKA Zelboraf 240 mg filmom obložene tablete.
English: ● Medicines that stimulate the metabolising proteins called CYP3A4 or a metabolising process called glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort)
Croatian: • Lijekove koji stimuliraju metaboličke bjelančevine CYP3A4 ili metabolički proces koji se zove glukuronidacija (npr. rifampicin, rifabutin, karbamazepin, fenitoin ili gospina trava).
English: Biliary excretion appears to be another important elimination pathway.
Croatian: Čini se da je drugi važan put eliminacije izlučivanje putem žuči.
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.
Croatian: U testovima in vitro (bakterijska mutacija [AMES test], aberacija kromosoma u humanim limfocitima) ni u mikronukleus testu koštane srži štakora in vivo provedenima s vemurafenibom nisu otkriveni znakovi genotoksičnosti.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku Za primjenu kroz usta
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
Croatian: Medijan (mjeseci) (95% CI)d a Stopa najboljeg ukupnog potvrđenog odgovora prema ocjeni neovisnog ocjenjivačkog povjerenstva, broj bolesnika s odgovorom, n (%) b Dvostrani Clopper-Pearsonov interval pouzdanosti (CI) od 95%
English: Potentiation of radiation treatment toxicity has been reported in patients receiving vemurafenib (see sections 4.4 and 4.8).
Croatian: U bolesnika koji su primali vemurafenib prijavljeno je pojačavanje toksičnosti radioterapije (vidjeti dijelove 4.4 i 4.8).
English: Progression of pre-existing pancreatic adenocarcinoma with KRAS mutation.
Croatian: (5) Progresija postojećeg adenokarcinoma gušterače s mutacijom gena KRAS.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 240 mg vemurafeniba (u obliku koprecipitata vemurafeniba i hipromeloze acetatsukcinata).
English: Dose reduction and/or additional drug level monitoring for P-gp substrate medicinal products with narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) may be considered if these medicinal products are used concomitantly with vemurafenib (see section 4.5).
Croatian: Može se razmotriti smanjenje doze i/ili dodatno praćenje razine lijekova koji su supstrati P-gp-a i imaju uzak terapijski indeks (npr. digoksin, dabigatraneteksilat, aliskiren) ako se ti lijekovi primjenjuju istodobno s vemurafenibom (vidjeti dio 4.5).
English: Concomitant use of vemurafenib with agents metabolized by CYP1A2 with narrow therapeutic windows (e.g. agomelatine, alosetron, duloxetine, melatonin, ramelteon, tacrine, tizanidine, theophylline) is not recommended.
Croatian: Ne preporučuje se istodobna primjena vemurafeniba s lijekovima koji se metaboliziraju putem CYP1A2, a imaju usku terapijsku širinu (npr. agomelatin, alosetron, duloksetin, melatonin, ramelteon, takrin, tizanidin, teofilin).
English: Call a doctor immediately.
Croatian: • osjećaj da ćete se onesvijestiti, odmah pozovite liječnika.
English: Monitoring of these lesions occurs as outlined above for cutaneous squamous cell carcinoma.
Croatian: Kontrole tih oštećenja kože provode se na isti način kako je ranije navedeno za planocelularni karcinom kože.
English: In patients who experience severe hypersensitivity reactions, vemurafenib treatment should be permanently discontinued.
Croatian: U bolesnika koji razviju tešku reakciju preosjetljivosti potrebno je trajno obustaviti liječenje vemurafenibom.
English: Dose adjustments for medicinal products predominantly metabolised via CYP1A2 or CYP3A4 should be considered based on their therapeutic windows before concomitantly treating with vemurafenib (see sections 4.5 and 4.6).
Croatian: Prije početka istodobne primjene s vemurafenibom potrebno je razmotriti prilagodbu doze lijekova koji se pretežno metaboliziraju putem CYP1A2 ili CYP3A4 na temelju njihove terapijske širine (vidjeti dijelove 4.5 i 4.6).
English: The most common adverse drug reactions (ADR) of any grade (> 30%) reported with vemurafenib include arthralgia, fatigue, rash, photosensitivity reaction, alopecia, nausea diarrhea, headache,
Croatian: Najčešće nuspojave bilo kojeg stupnja (> 30%) prijavljene kod liječenja vemurafenibom uključuju artralgiju, umor, osip, fotosenzitivne reakcije, alopeciju, mučninu, proljev, glavobolju, pruritus, povraćanje, kožni papilom i hiperkeratozu.
English: Photosensitivity reaction, actinic keratosis, rash, rash maculo-papular, pruritus, hyperkeratosis, erythema, palmarplantar erythrodysaesthesia syndrome, alopecia, dry skin, sunburn
Croatian: Poremećaji kože i potkožnog tkiva fotosenzitivne reakcije, aktinička keratoza, osip, makulopapularni osip, pruritus, hiperkeratoza, eritem, sindrom palmarno-plantarne eritrodizestezije, alopecija, suha koža, sunčane opekline papularni osip, panikulitis (uključujući nodozni eritem), folikularna keratoza toksična epidermalna nekroliza
English: Liver injury, including cases of severe liver injury, has been reported with vemurafenib (see section 4.8).
Croatian: Oštećenje tkiva jetre, uključujući slučajeve teškog oštećenja tkiva jetre, prijavljeno je pri liječenju vemurafenibom (vidjeti dio 4.8).
English: ● A type of cancer (non-cutaneous squamous cell carcinoma)
Croatian: • vrsta raka kože (planocelularni karcinom koji nije na koži)
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetke (mogu se javiti u do 1 na 1000 osoba):
English: ● Medicines that strongly inhibit the metabolising protein called CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir)
Croatian: • Lijekove koji snažno potiskuju aktivnost metaboličke bjelančevine CYP3A4 (npr. ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol, nefazodon, atazanavir).
English: CuSCC was most commonly treated by local excision.
Croatian: Planocelularni karcinom kože najčešće je liječen lokalnom ekscizijom.
English: In patients who experience a severe dermatologic reaction, vemurafenib treatment should be permanently discontinued.
Croatian: U bolesnika koji razviju tešku kožnu reakciju potrebno je trajno obustaviti liječenje vemurafenibom.
English: Maintain vemurafenib at a dose of 960 mg twice daily.
Croatian: Stupanj 1 ili Stupanj 2 (podnošljivo) Održavati dozu vemurafeniba od 960 mg dvaput na dan.
English: In vitro studies suggest that CYP3A4 metabolism and glucuronidation are responsible for the metabolism of vemurafenib.
Croatian: Ispitivanja in vitro ukazuju da su za metabolizam vemurafeniba odgovorni metabolizacija putem CYP3A4 i glukuronidacija.
English: There are only limited data available in patients with severe renal impairment (see section 5.2).
Croatian: Podaci u bolesnika s teškim oštećenjem bubrežne funkcije su vrlo ograničeni (vidjeti dio 5.2).
English: Reversible toxic effects (hepatocellular necrosis and degeneration) in the liver at exposures below the anticipated clinical exposure (based on AUC comparisons) were noted in the 13-week dog study.
Croatian: U 13-tjednom istraživanju u pasa opaženi su reverzibilni toksični učinci u jetri (hepatocelularna nekroza i degeneracija) pri izloženosti manjoj od izloženosti očekivane u kliničkoj primjeni (na temelju usporedbe AUC-a).
English: ● Severe skin reactions can happen while taking Zelboraf.
Croatian: • Dok uzimate Zelboraf mogu nastati teške kožne reakcije.
English: ● Headache
Croatian: • glavobolja
English: No cases of overdose have been observed with vemurafenib in clinical trials.
Croatian: U kliničkim ispitivanjima nisu zabilježeni slučajevi predoziranja vemurafenibom.
English: Each film-coated tablet contains 240 milligrams (mg) of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Croatian: Jedna filmom obložena tableta sadrži 240 miligrama (mg) vemurafeniba (u obliku koprecipitata vemurafeniba i hipromeloze acetatsukcinata).
English: Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Hydroxypropylcellulose
Croatian: Jezgra tablete karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat hidroksipropilceluloza
English: A decision must be made whether to discontinue breast-feeding or to discontinue vemurafenib therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Uzimajući u obzir korist dojenja za dijete i dobrobit liječenja za ženu, nužno je donijeti odluku o tome hoće li se prekinuti dojenje ili privremeno ili trajno obustaviti liječenje vemurafenibom.
English: Mild to severe photosensitivity was reported in patients who received vemurafenib in clinical studies (see section 4.8).
Croatian: U bolesnika koji su primali vemurafenib u kliničkim ispitivanjima zabilježena je blaga do umjerena fotosenzitivnost (vidjeti dio 4.8).
English: ● Skin rash, blistering, peeling or discoloration of the skin
Croatian: ● kožni osip, mjehure po koži, ljuštenje ili promjenu boje kože
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.
Croatian: Omjeri geometrijskih sredina za Cmax i AUC bili su 2,5 odnosno 4,6 do 5,1 puta veći kod uzimanja lijeka na pun želudac u odnosu na uzimanje natašte.
English: All patients treated were at least 15 years of age and weighed at least 45 kg. Three patients were treated with vemurafenib 720 mg twice daily, and three patients were treated with vemurafenib 960 mg twice daily.
Croatian: Tri su bolesnika liječena vemurafenibom u dozi od 720 mg dvaput na dan, a tri bolesnika vemurafenibom u dozi od 960 mg dvaput na dan.
English: Exercise caution and consider additional INR (International Normalised Ratio) monitoring when vemurafenib is used concomitantly with warfarin.
Croatian: International Normalised Ratio, INR) kada se vemurafenib primjenjuje istodobno s varfarinom.
English: Eye problems
Croatian: Tegobe s očima
English: Cases of cuSCC (which include those classified as keratoacanthoma or mixed keratoacanthoma subtype) have been reported in patients treated with vemurafenib (see section 4.8).
Croatian: U bolesnika liječenih vemurafenibom zabilježeni su slučajevi planocelularnog karcinoma kože (koji uključuju one klasificirane kao keratoakantom ili podtipove miješanog keratoakantoma) (vidjeti dio 4.8).
English: It is not known whether vemurafenib is excreted in human milk.
Croatian: Nije poznato izlučuje li se vemurafenib u majčino mlijeko.
English: Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma (see section 4.8).
Croatian: U nekontroliranom otvorenom kliničkom ispitivanju faze II u prethodno liječenih bolesnika s metastatskim melanomom opaženo je produljenje QT-intervala ovisno o izloženosti lijeku (vidjeti dio 4.8).
English: Vemurafenib is for oral use.
Croatian: Vemurafenib se primjenjuje kroz usta.
English: ● Abnormal kidney blood test results (creatinine increased).
Croatian: • odstupanja u nalazima krvnih pretraga bubrežne funkcije (povišena vrijednost kreatinina)
English: Immune System Disorders
Croatian: Poremećaji imunološkog sustava sarkoidoza
English: February 1,
Croatian: Podaci do zaključno 1. veljače 2012.
English: December 30,
Croatian: Podaci do zaključno 30. prosinca 2010.
English: There are only very limited data available in patients with moderate to severe hepatic impairment.
Croatian: Podaci u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije su vrlo ograničeni.
English: Events originating from safety reports across all trials (2) Events originating from post-marketing sources.
Croatian: (1) Događaji koji potječu iz izvješća o sigurnosti primjene iz svih ispitivanja
English: Number of crossover patients (%)
Croatian: Broj smrtnih ishoda (%)
English: Number of deaths
Croatian: BROJ SERIJE
English: Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with vemurafenib in the post-marketing setting (see section 4.8).
Croatian: Nakon stavljanja lijeka u promet kod primjene vemurafeniba prijavljena je reakcija na lijek uz eozinofiliju i sustavne simptome (DRESS) (vidjeti dio 4.8).
English: Progression-free survival Hazard Ratio (95% CI)
Croatian: Preživljenje bez progresije bolesti Omjer hazarda (95% CI)
English: Cases of radiation recall and radiation sensitization have been reported in patients treated with radiation either prior, during, or subsequent to vemurafenib treatment.
Croatian: U bolesnika liječenih radioterapijom prije, tijekom ili nakon liječenja vemurafenibom prijavljeni su slučajevi upalnih reakcija na ozračenom mjestu (engl. radiation recall) i pojačane osjetljivosti na zračenje.
English: Toxic epidermal necrolysis (e), StevensJohnson syndrome (f)
Croatian: StevensJohnsonov sindrom
English: Liver injury(1)(2) (g)
Croatian: (1)(2) (g)
English: Stage MIC
Croatian: Stadij M1C
English: Liver injury
Croatian: Oštećenje tkiva jetre
English: Nine of the 132 patients enrolled into NP22657 had V600K mutation-positive tumours according to retrospective Sanger sequencing.
Croatian: Prema retrospektivnom sekvencioniranju Sangerovom metodom, 9 od 132 bolesnika uključena u ispitivanje NP22657 imalo je tumore s pozitivnom mutacijom V600K.
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib (see sections 4.3 and 4.8).
Croatian: Kod liječenja vemurafenibom zabilježene su ozbiljne reakcije preosjetljivosti, uključujući anafilaksiju (vidjeti dijelove 4.3 i 4.8).
English: Drug reaction with eosinophilia and systemic symptoms(1)(2)
Croatian: reakcija na lijek uz eozinofiliju i sustavne simptome
English: ● Inflammation of blood vessels
Croatian: • upala krvnih žila
English: PFS - brain only Median (months)e
Croatian: PFS - samo mozak
English: No adjustment to the starting dose is needed for patients with hepatic impairment.
Croatian: U bolesnika s oštećenjem jetrene funkcije nije potrebna prilagodba početne doze.
English: Grade 4 1st occurrence of any grade 4 AE Discontinue permanently or interrupt vemurafenib treatment until grade 0 - 1.
Croatian: Trajno obustaviti ili privremeno prekinuti liječenje vemurafenibom dok se ne postigne stupanj 0 - 1.
English: Focal bone marrow necrosis was noted in one dog in a prematurely terminated 39-week BID dog study at exposures similar to the anticipated clinical exposure (based on AUC comparisons).
Croatian: U jednoga je psa u prijevremeno prekinutom 39-tjednom istraživanju (doziranje dvaput na dan) pri izloženosti sličnoj izloženosti očekivanoj u kliničkoj primjeni (na temelju usporedbe AUC-a) opažena fokalna nekroza koštane srži.
English: Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Croatian: Prije primjene vemurafeniba u bolesnika se validiranim testom mora potvrditi da je tumor pozitivan na BRAF mutaciju V600.
English: Treatment
Croatian: Lijek
English: Arthralgia, myalgia, pain in extremity, musculoskeletal pain, back pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija, mialgija, bol u udovima, mišićno-koštana bol, bol u leđima artritis
English: No adjustment to the starting dose is needed for patients with mild or moderate renal impairment.
Croatian: U bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije nije potrebna prilagodba početne doze.
English: Table 5: Acute kidney injury cases in the phase III study Vemurafenib (%) Dacarbazine (%)
Croatian: Tablica 5: Slučajevi akutnog oštećenja tkiva bubrega u ispitivanju faze III
English: Worsening of radiation treatment side effects can occur in patients who are treated with radiation before, during, or after Zelboraf treatment.
Croatian: U bolesnika koji su prije, tijekom ili nakon liječenja lijekom Zelboraf liječeni zračenjem može doći do pogoršanja nuspojava liječenja zračenjem.
English: Hepatic enzyme increase (c)
Croatian: Povišene vrijednosti jetrenih enzima
English: Effect of other medicinal products on vemurafenib
Croatian: Učinci vemurafeniba na druge lijekove
English: Most patients were male (56%) and Caucasian (99%), the median age was 54 years (24% were ≥ 65 years), all patients had ECOG performance status of 0 or 1, and the majority of patients had stage M1c disease (65%).
Croatian: Većina je bolesnika bila muškog spola (56%) i bijele rase (99%), a medijan dobi iznosio je 54 godine (24% bolesnika imalo je ≥ 65 godina).
English: Limited data are available in patients with hepatic impairment.
Croatian: Podaci u bolesnika s oštećenjem jetrene funkcije su ograničeni.
English: QTc>500 ms at baseline
Croatian: QTc > 500 ms na početku liječenja
English: ● Inflammation of the fatty tissue under the skin
Croatian: • upala potkožnog masnog tkiva.
English: QTc increase meets values of both >500 ms and >60 ms change from pre-treatment values
Croatian: Produljenje QTc na > 500 ms i promjena za > 60 ms u odnosu na vrijednosti prije liječenja
English: CYP3A4 is the primary enzyme responsible for the metabolism of vemurafenib in vitro.
Croatian: Primarni enzim odgovoran za metabolizam vemurafeniba in vitro je CYP3A4.
English: Fatigue, pyrexia, oedema peripheral, asthenia
Croatian: Opći poremećaji i reakcije na mjestu primjene umor, pireksija, periferni edem, astenija
English: Pancreatitis has been reported in vemurafenib-treated subjects.
Croatian: U ispitanika liječenih vemurafenibom prijavljen je pankreatitis.
English: Concomitant use of vemurafenib with agents metabolized by CYP3A4 with narrow therapeutic windows is not recommended.
Croatian: Ne preporučuje se istodobna primjena vemurafeniba s lijekovima koji se metaboliziraju putem CYP3A4, a imaju usku terapijsku širinu.
English: Surveillance for non-cuSCC should occur as outlined in section 4.4.
Croatian: Potrebno je provoditi mjere nadzora pojave planocelularnog karcinoma koji nije na koži kako je opisano u dijelu 4.4.
English: Table 9: Overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma vemurafenib dacarbazine p-value (x)
Croatian: Tablica 9: Stopa ukupnog odgovora na liječenje i preživljenje bez progresije bolesti u prethodno neliječenih bolesnika s melanomom s pozitivnom BRAF mutacijom V600
English: ● Diarrhoea
Croatian: • kašalj