FrancophonIA/ELRC3.0 huggingface dataset:
English: Vemurafenib revealed no evidence of teratogenicity in rat or rabbit embryo/foetuses (see section 5.3).
Slovenian: Vemurafenib ni pokazal znakov teratogenosti pri zarodkih podgan ali kunčjih samic (glejte poglavje 5.3).
English: Patients co-treated with such agents should be carefully monitored for safety and dose modifications applied if clinically indicated (see Table 1 in section 4.2).
Slovenian: Bolnike, ki se sočasno zdravijo s temi zdravili, je treba skrbno spremljati glede varnosti in prilagoditi odmerek, če je klinično indicirano (glejte preglednico 1 v poglavju 4.2).
English: 2nd occurrence of any grade 4 AE or persistence of any grade 4 AE after 1st dose reduction
Slovenian: 2. pojav katerega koli neželenega dogodka stopnje 4 ali prisotnost katerega koli neželenega dogodka stopnje 4 po 1. zmanjšanju odmerka
English: What Zelboraf contains
Slovenian: Kaj vsebuje zdravilo Zelboraf
English: Median (months) (95% CI)d
Slovenian: mediana (meseci) (95-% IZ)
English: A single-arm, multicentre study (N = 146) of vemurafenib was conducted in adult patients with histologically confirmed metastatic melanoma harbouring the BRAF V600 mutation (according to the cobas 4800 BRAF V600 Mutation Test) and with brain metastases.
Slovenian: Multicentrična študija z enim krakom (n = 146), v kateri so preskušali vemurafenib, je bila izvedena pri odraslih bolnikih s histološko potrjenim metastatskim melanomom z mutacijo BRAF V600 (glede na cobas 4800 BRAF V600 Mutation Test) in zasevki v možganih.
English: In case of suspected overdose, vemurafenib should be withheld and supportive care initiated.
Slovenian: Pri sumu na preveliko odmerjanje je treba uporabo vemurafeniba prekiniti in uvesti podporno oskrbo.
English: ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
Slovenian: Povzetek neželenih učinkov, prikazan v preglednicah Neželeni učinki, o katerih so poročali pri bolnikih z melanomom, so navedeni spodaj po organskih sistemih MedDRA, pogostnosti in stopnji izrazitosti.
English: ● medicines for nausea and vomiting (e.g. ondansetron, domperidone).
Slovenian: • zdravila proti slabosti in bruhanju (npr. ondasetron, domperidon);
English: ● Progression of a type of pre-existing cancers with RAS mutations (Chronic Myelomonocytic
Slovenian: • napredovanje že prej prisotnih vrst rakov z mutacijami RAS (kronične mielomonocitne levkemije, adenokarcinoma trebušne slinavke),
English: How to take Zelboraf
Slovenian: Kako jemati zdravilo Zelboraf
English: CuSCC was most commonly treated by local excision.
Slovenian: Ploščatocelični karcinom kože so večinoma zdravili z lokalno ekscizijo.
English: In patients who develop cuSCC, it is recommended to continue the treatment without dose adjustment.
Slovenian: Pri bolnikih, ki se jim pojavi ploščatocelični karcinom kože, je priporočljivo nadaljevati zdravljenje brez zmanjšanja odmerka.
English: Progression of pre-existing chronic myelomonocytic leukaemia with NRAS mutation.
Slovenian: (4) Napredovanje že prej obstoječe kronične mielomonocitne levkemije z mutacijo NRAS.
English: It cannot be excluded that vemurafenib pharmacokinetics could be affected by such medicines through influence on P-gp (e.g. verapamil, cyclosporine, quinidine) or BCRP (e.g. cyclosporine, gefitinib).
Slovenian: Ne moremo pa izključiti možnosti, da lahko takšna zdravila prek vpliva na P-gp (npr. verapamil, ciklosporin, kinidin) ali BCRP (npr. ciklosporin, gefitinib) vplivajo na farmakokinetiko vemurafeniba.
English: If you take more Zelboraf than you should, talk to your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Zelboraf, kot bi smeli Če ste vzeli večji odmerek zdravila Zelboraf, kot bi smeli, se nemudoma posvetujte z zdravnikom.
English: Tell your doctor immediately if you get eye pain, swelling, redness, blurred vision or other vision changes during your treatment.
Slovenian: Če se med zdravljenjem pojavi bolečina v očeh, oteklost, rdečica, zamegljen vid ali druge spremembe vida, se takoj posvetujte z zdravnikom.
English: Following discontinuation of vemurafenib, monitoring for non-cuSCC should continue for up to 6 months or until initiation of another anti-neoplastic therapy.
Slovenian: Po prenehanju zdravljenja z vemurafenibom se mora nadzor glede ploščatoceličnega karcinoma, ki se ne nahaja na koži, nadaljevati še 6 mesecev ali do uvedbe drugega antineoplastičnega zdravljenja.
English: During clinical trials with vemurafenib, grade 3 adverse reactions reported more frequently in females than males were rash, arthralgia and photosensitivity.
Slovenian: Med neželene učinke stopnje 3, ki so bili med kliničnimi preskušanji vemurafeniba pri ženskah opisani pogosteje kot pri moških, spadajo kožni izpuščaj, artralgija in fotosenzibilnost.
English: It cannot be excluded that vemurafenib may increase the exposure of medicines transported by BCRP (e.g. methotrexate, mitoxantrone, rosuvastatin).
Slovenian: Možnosti, da vemurafenib poveča izpostavljenost zdravilom, ki se prenašajo z BCRP (npr. metotreksatu, mitoksantronu, rosuvastatinu), ni mogoče izključiti.
English: Like all medicines, Zelboraf can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: • Very common: GGT
Slovenian: • zelo pogosti: GGT (gama-glutamiltransferaza);
English: However, in repeat-dose toxicity studies, no histopathological findings were noted on reproductive organs in males and females in rats and dogs at doses up to 450 mg/kg/day (at exposures below the anticipated clinical exposure based on AUC comparison).
Slovenian: Toda v študijah toksičnosti ponavljajočih se odmerkov niso ugotovili histopatoloških izsledkov na reproduktivnih organih samcev in samic pri podganah in psih v odmerkih do 450 mg/kg/dan (pri izpostavljenostih, nižjih od pričakovanih kliničnih izpostavljenosti na podlagi primerjanih AUC).
English: The relative proportions of vemurafenib and its metabolites were characterised in a human mass balance study with a single dose of 14C-labeled vemurafenib administered orally.
Slovenian: Sorazmerne deleže vemurafeniba in njegovih presnovkov so določili v raziskavi masnega ravnovesja pri človeku z enkratnim odmerkom s
English: ● Severe skin reactions can happen while taking Zelboraf.
Slovenian: • Med jemanjem zdravila Zelboraf se lahko pojavijo hude kožne reakcije.
English: Change ≥ 1 grade from baseline to any grade Change ≥ 1 grade from baseline to grade 3 or higher
Slovenian: Zvišanje ravni kreatinina od izhodišča (za 1 stopnjo ali več) do katere koli stopnje Zvišanje ravni kreatinina od izhodišča (za 1 stopnjo ali več) do stopnje 3 ali več
English: Beware of fatigue or eye problems that could be a reason for not driving.
Slovenian: Zavedati se morate, da se lahko pojavita utrujenost in težave z očmi, zaradi katerih se je vožnji morda bolje odpovedati.
English: In animal studies, vemurafenib was found to cross the placenta.
Slovenian: V študijah na živalih so ugotovili, da vemurafenib prehaja placento.
English: Musculoskeletal/Connective Tissue disorder
Slovenian: Bolezni mišično-skeletnega sistema/vezivnega tkiva
English: If co-administration cannot be avoided, exercise caution, as vemurafenib may increase plasma exposure of CYP1A2 substrate drugs.
Slovenian: Če se sočasnemu dajanju ne moremo izogniti, je potrebna previdnost, ker lahko vemurafenib poveča izpostavljenost v plazmi zdravilom, ki so substrati CYP1A2.
English: ● Medicines that could be influenced by a protein called P-gp (e.g. aliskiren, colchicine, digoxin, everolimus, fexofenadine) or a protein called BCRP (e.g. methotrexate, mitoxantrone, rosuvastatin).
Slovenian: • zdravila, na katera lahko vpliva beljakovina P-gp (npr. aliskiren, kolhicin, digoksin, everolimus, feksofenadin) ali beljakovina, imenovana BCRP (npr. metotreksat, mitoksantron, rosuvastatin);
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.
Slovenian: V populacijski farmakokinetični analizi podatkov pridobljenih iz kliničnih preskušanj bolnikov z metastatskim melanomom, zvišanje aspartat aminotransferaze (AST) in alanin aminotransferaze (ALT) do trikratne vrednosti zgornje meje normalne vrednosti ni vplivalo na navidezni očistek vemurafeniba.
English: Serious ophthalmologic reactions, including uveitis, iritis and retinal vein occlusion, have been reported.
Slovenian: Poročali so o resnih neželenih učinkih na očeh, vključno z uveitisom, iritisom in zaporo mrežnične vene.
English: Posology adjustments
Slovenian: Prilagoditve odmerjanja
English: ● Skin rash, blistering, peeling or discoloration of the skin
Slovenian: • kožni izpuščaj, mehurje, luščenje ali obarvanje kože,
English: ● Medicines that are mainly eliminated by metabolising proteins called CYP1A2 (e.g caffeine, olanzapine, theophylline), CYP3A4 (e.g. some oral contraceptives) or called CYP2C8.
Slovenian: • zdravila, ki se večinoma izločajo z beljakovinami, ki sodelujejo pri presnovi, imenovanimi CYP1A2 (npr. kofein, olanzapin, teofilin), CYP3A4 (npr. nekatera peroralna kontracepcijska sredstva) ali CYP2C8;
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).
Slovenian: Teratogenosti niso opazili v študijah razvoja zarodkov in plodov pri podganah in kunčjih samicah pri odmerkih do 250 mg/kg/dan in 450 mg/kg/dan; te izpostavljenosti so nižje od pričakovanih kliničnih izpostavljenosti (na podlagi primerjanih AUC).
English: Taking too much Zelboraf may increase the likelihood and severity of side effects.
Slovenian: Uporaba prevelikega odmerka zdravila Zelboraf lahko poveča verjetnost za pojav neželenih učinkov ali neželene učinke poslabša.
English: This inhibitory effect was confirmed in the ERK phosphorylation and cellular anti-proliferation assays in available melanoma cell lines expressing V600-mutant BRAF.
Slovenian: Zaviralen učinek je bil potrjen z analizo fosforilacije ERK (extracelullar signal-regulated kinase) in testi proliferacije celic pri celičnih linijah melanoma, ki imajo izraženo V600 mutacijo BRAF.
English: ● Allergic reactions can happen while taking Zelboraf and may be severe.
Slovenian: • Med jemanjem zdravila Zelboraf lahko pride do alergijske reakcije, ki je lahko huda.
English: ● Shortness of breath, which may be accompanied by a cough, fever or chills (pneumonitis)
Slovenian: • zasoplost, ki jo lahko spremlja kašelj, zvišana telesna temperatura ali mrazenje (pnevmonitis),
English: The median Tmax was increased from 4 to 7.5 hours when a single vemurafenib dose was taken with food.
Slovenian: Mediani tmax je bil po enkratnem odmerku vemurafeniba, vzetem s hrano, povečan s 4 na 7,5 ur.
English: (a)
Slovenian: (e)
English: This is a precautionary measure in case a squamous cell carcinoma lesion would develop inside your body.
Slovenian: Takšni preventivni pregledi so namenjeni odkrivanju lezij ploščatoceličnega karcinoma, ki se lahko razvijejo v vašem telesu.
English: No adjustment to the starting dose is needed for patients with mild or moderate renal impairment.
Slovenian: Bolnikom z blago ali zmerno ledvično okvaro začetnih odmerkov ni treba prilagajati.
English: Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).
Slovenian: Vemurafenib je indiciran za samostojno zdravljenje odraslih bolnikov z neresektabilnim ali metastatskim melanomom, s pozitivno mutacijo BRAF V600 (glejte poglavje 5.1).
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.
Slovenian: Sočasna uporaba vemurafeniba z učinkovinami, ki se presnavljajo prek CYP1A2 in imajo ozko terapevtsko okno (npr. agomelatinom, alosetronom, duloksetinom, melatoninom, ramelteonom, takrinom, tizanidinom, teofilinom), ni priporočljiva.
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.
Slovenian: Sočasna uporaba močnih induktorjev P-gp, glukuronidacije in/ali CYP3A4 (npr. rifampicina, rifabutina, karbamazepina, fenitoina ali šentjanževke [Hypericum perforatum]) lahko vodi v suboptimalno izpostavljenost vemurafenibu in se ji je treba izogibati.
English: 2nd occurrence of any grade 2 or 3 AE or persistence after treatment interruption
Slovenian: 2. pojav katerega koli neželenega dogodka stopnje 2 ali 3 ali prisotnost tudi po prekinitvi zdravljenja
English: ● If you get any side effects, talk to your doctor.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
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).
Slovenian: Pred uporabo vemurafeniba je treba z validirano preiskavo potrditi, da ima bolnik tumor s pozitivno mutacijo BRAF V600 (glejte poglavji 4.4 in 5.1).
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).
Slovenian: Pri sočasni uporabi ipilimumaba (3 mg/kg) in vemurafeniba (960 mg dvakrat na dan ali 720 mg dvakrat na dan) so v preskušanju faze I poročali o asimptomatskih zvišanjih transaminaz (ALT/AST > 5 x ULN) in bilirubina (celokupni bilirubin > 3 x ULN) stopnje 3.
English: ● Medicines that strongly inhibit the metabolising protein called CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir)
Slovenian: • zdravila, ki močno zavirajo presnovno beljakovino, imenovano CYP3A4 (npr. ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol, nefazodon, atazanavir);
English: Table 9 shows the overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma.
Slovenian: Preglednica 9 prikazuje celokupni odziv in preživetje brez napredovanja bolezni pri predhodno nezdravljenih bolnikih z melanomom s pozitivno BRAF V600 mutacijo.
English: Concomitant administration of strong inducers of CYP3A4, P-gp and glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort [hypericin]) might lead to decreased exposure of vemurafenib and should be avoided when possible (see section 4.5).
Slovenian: Sočasno dajanje močnih induktorjev CYP3A4, P-gp in glukuronidacije (npr. rifampicina, rifabutina, karbamazepina, fenitoina ali šenjanževke [hipericin]) lahko vodi do zmanjšane izpostavljenosti vemurafenibu, zato se mu je treba izogibati, kadar je to mogoče (glejte poglavje 4.5).
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).
Slovenian: Po prihodu vemurafeniba na trg so v povezavi z njim poročali o reakciji na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms) (glejte poglavje 4.8).
English: Within each frequency grouping, ADRs are presented in order of decreasing severity and were reported using NCI-CTCAE v 4.0 (common toxicity criteria) for assessment of toxicity.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti; neželeni učinki so bili poročani v skladu z lestvico skupnih kriterijev toksičnosti (NCI-CTCAE v4.0).
English: ● medicines for depression (e.g. amitriptyline, imipramine)
Slovenian: • zdravila proti depresiji (npr. amitriptilin, imipramin),
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).
Slovenian: Pred sočasnim zdravljenjem z vemurafenibom moramo razmisliti o prilagoditvi odmerkov zdravil, ki se pretežno presnavljajo prek CYP1A2 ali CYP3A4, glede na njihovo terapevtsko okno (glejte poglavji 4.5 in 4.6).
English: No adjustment to the starting dose is needed for patients with hepatic impairment.
Slovenian: Bolnikom z jetrno okvaro začetnih odmerkov ni treba prilagajati.
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.
Slovenian: Multicentrična mednarodna študija faze II, ki je vključevala le eno skupino, je bila opravljena pri 132 bolnikih z metastatskim melanomom s pozitivno BRAF V600 mutacijo glede na mutacijski test cobas 4800 BRAF V600 Mutation Test, ki so prejeli vsaj eno predhodno zdravljenje.
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Slovenian: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Nemčija
English: Zelboraf 240 mg film-coated tablets vemurafenib
Slovenian: Zelboraf 240 mg filmsko obložene tablete vemurafenib
English: There are only very limited data available in patients with moderate to severe hepatic impairment.
Slovenian: Podatkov o bolnikih z zmerno do hudo jetrno okvaro je le malo.
English: Diarrhoea, vomiting, nausea, constipation
Slovenian: Bolezni prebavil driska, bruhanje, slabost, zaprtost pankreatitis
English: ● Tablet core: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate
Slovenian: • jedro tablete: brezvodni koloidni silicijev dioksid, premreženi natrijev karmelozat, hidroksipropilceluloza, magnezijev stearat;
English: ● Medicines that influence a protein called P-gp or BCRP (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole, gefitinib).
Slovenian: • zdravila, ki vplivajo na beljakovino, imenovano P-gp ali BCRP (npr. verapamil, ciklosporin, ritonavir, kinidin, itrakonazol, gefitinib);
English: Vemurafenib was shown to be phototoxic, in vitro, on cultured murine fibroblasts after UVA irradiation, but not in vivo in a rat study at doses up to 450 mg/kg/day (at exposures below the anticipated clinical exposure (based on AUC comparison).
Slovenian: In vitro se je vemurafenib izkazal za fototoksičnega v kulturi mišjih fibroblastov po obsevanju z UVA, ne pa tudi v študiji in vivo na podganah pri odmerkih do 450 mg/kg/dan (pri izpostavljenostih, nižjih od pričakovanih kliničnih izpostavljenosti na podlagi primerjanih AUC).
English: Of the specimens available from the non-clinical and clinical studies (n=920), that were mutation-positive by the cobas test and additionally analyzed by sequencing, no specimen was identified as being wild type by both Sanger and 454 sequencing.
Slovenian: Vzorcem, ki so bili na voljo iz nekliničnih in kliničnih študij (n = 920) in pri katerih je bila glede na test cobas prisotna mutacija, so še dodatno določili zaporedje.
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).
Slovenian: Če se pri bolniku pojavi ploščatocelični karcinom kože, priporočamo nadaljevanje zdravljenja brez zmanjšanja odmerka vemurafeniba (glejte poglavji 4.4 in 4.8).
English: A total of 57 patients out of 673 whose tumours were analysed retrospectively by sequencing were reported to have BRAF V600K mutation-positive melanoma in NO25026.
Slovenian: V študiji NO25026 so skupno 57 bolnikom od 673, z retrospektivnim določanjem zaporedja, določili melanom s pozitivno BRAF V600K mutacijo.
English: 3rd occurrence of any grade 2 or 3 AE or persistence after 2nd dose reduction
Slovenian: 3. pojav katerega koli neželenega dogodka stopnje 2 ali 3 ali prisotnost tudi po 2. zmanjšanju odmerka
English: Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000
Slovenian: Občasni: ≥ 1/1.000 do < 1/100
English: Upon Data Safety Monitoring Board (DSMB) recommendation, those results were released in January 2011 and the study was modified to permit dacarbazine patients to cross over to receive vemurafenib.
Slovenian: V skladu s priporočili Data Safety Monitoring Board (DSMB) so te rezultate objavili januarja 2011.
English: No cases of overdose have been observed with Zelboraf.
Slovenian: Pri zdravilu Zelboraf niso zasledili primerov prevelikega odmerjanja.
English: Co-administration of vemurafenib increased the plasma exposure (AUC) of caffeine (CYP1A2 substrate) 2.6-fold.
Slovenian: Sočasno dajanje vemurafeniba in kofeina je kofeinu (substratu CYP1A2) 2,6-kratno povečalo izpostavljenost v plazmi (AUC).
English: ● In case of vomiting, continue to take Zelboraf as usual and do not take an additional dose.
Slovenian: • Če bruhate, ne vzemite dodatnega odmerka, z jemanjem zdravila Zelboraf nadaljujte normalno.
English: Censored results at time of cross-over
Slovenian: podatki, krnjeni v času prehoda na vemurafenib
English: ● Rash, itching, dry or scaly skin
Slovenian: • kožni izpuščaj, srbenje, suha ali luskasta koža,
English: Potentiation of radiation toxicity
Slovenian: Povečanje toksičnosti obsevanja
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 240 mg vemurafeniba (v obliki precipitata vemurafeniba in hipromeloze acetat sukcinata).
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)
Slovenian: Preglednica 9: Celokupni odziv in preživetje brez napredovanja bolezni pri predhodno nezdravljenih bolnikih z melanomom s pozitivno BRAF V600 mutacijo vemurafenib dakarbazin p-vrednost
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,
Slovenian: Med najpogostejšimi neželenimi učinki vseh stopenj (> 30 %), o katerih so poročali v zvezi z vemurafenibom, so artralgija, utrujenost, kožni izpuščaj, fotosenzibilnostna reakcija, alopecija, navzea, diareja, glavobol, srbenje, bruhanje, kožni papilomi in hiperkeratoza.
English: ● Weight loss
Slovenian: • izguba teka,
English: A total of 675 patients were randomised to vemurafenib (n=337) or dacarbazine (n=338).
Slovenian: Skupaj je bilo randomiziranih 675 bolnikov, 337 zdravljenih z vemurafenibom in 338 z dakarbazinom.
English: Mild to severe photosensitivity was reported in patients who received vemurafenib in clinical studies (see section 4.8).
Slovenian: Pri bolnikih, ki so v kliničnih študijah prejemali vemurafenib, je bila opisana blaga do huda fotosenzibilnost (glejte poglavje 4.8).
English: ● A type of cancer (non-cutaneous squamous cell carcinoma)
Slovenian: • vrsta raka (ploščatocelični karcinom, ki se ne nahaja na koži),
English: Potentiation of radiation treatment toxicity has been reported in patients receiving vemurafenib (see sections 4.4 and 4.8).
Slovenian: Pri bolnikih, zdravljenih z vemurafenibom, so poročali o povečanju toksičnosti obsevanja (glejte poglavji 4.4 in 4.8).
English: Resume dosing at 480 mg twice daily (or discontinue permanently if the dose has already been lowered to 480 mg twice daily).
Slovenian: Ponovno začnite z odmerkom 480 mg dvakrat na dan (ali dokončno prenehajte, če je odmerek že bil znižan na 480 mg dvakrat na dan).
English: Dose reduction of the concomitant CYP1A2 substrate drug may be considered, if clinically indicated.
Slovenian: Razmisli se lahko o zmanjšanju odmerka sočasno uporabljenega zdravila, če je to klinično indicirano.