FrancophonIA/ELRC3.0 huggingface dataset:
English: If concomitant use of a strong CYP3A inhibitor is unavoidable, patients should be carefully monitored for safety.
Slovenian: Če je sočasna uporaba močnega inhibitorja encima CYP3A neizogibna, je potrebno varnost bolnikov pozorno spremljati.
English: Fatigue*
Slovenian: Utrujenost*
English: The incidences of liver laboratory abnormalities reported in the pooled Combo 450 population are listed below:
Slovenian: Nenormalen laboratorijski izvid delovanja jeter Pogostost nenormalnih laboratorijskih izvidov delovanja jeter, opaženih pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450, je navedena spodaj:
English: Headache*
Slovenian: Glavobol*
English: Cellulose microcrystalline (E460i) Succinic acid (E363) Crospovidone (E1202) Silica colloidal anhydrous (E551) Magnesium stearate (E470b)
Slovenian: Mikrokristalna celuloza (E460i) Jantarna kislina (E363) Krospovidon (E1202) Brezvodni koloidni silicijev dioksid (E551) Magnezijev stearat (E470b)
English: Based on findings in animals, the use of encorafenib may impact fertility in males of reproductive potential (see section 5.3).
Slovenian: Študije na živalih so pokazale, da lahko uporaba enkorafeniba vpliva na sposobnost razmnoževanja pri samcih (glejte poglavje 5.3).
English: While encorafenib is a relatively potent reversible inhibitor of UGT1A1, no differences in binimetinib exposure have been observed clinically when binimetinib was co-administered with encorafenib.
Slovenian: Učinek enkorafeniba na binimetinib Medtem ko je enkorafenib precej močen reverzibilni inhibitor UGT1A1, pa niso bile klinično opažene nobene razlike v izpostavljenosti binimetinibu, ko je bil binimetinib apliciran skupaj z enkorafenibom.
English: Diarrhoea led to dose discontinuation in 0.4% of patients and to dose interruption or dose modification in 4.4% of patients.
Slovenian: Zaradi driske se je pri 0,4 % bolnikov prenehalo odmerjanje, pri 4,4 % bolnikov pa se je odmerjanje prekinilo ali se je odmerek spremenil.
English: Muscle problems: Braftovi, when taken with binimetinib, can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include: - muscle pain, cramps, stiffness or spasm - dark urine
Slovenian: Težave z mišicami: Zdravilo Braftovi ob sočasnem jemanju z binimetinibom lahko povzroči razkroj mišic (rabdomioliza), zaradi česar lahko pride do okvare ledvic in smrti; znaki in simptomi lahko vključujejo: - bolečine v mišicah, krče, togost ali spazme,
English: • Grade 4
Slovenian: • 4. stopnja
English: Survival at 12 months (95% CI)
Slovenian: Preživetje pri 12 mesecih (95 % IZ)
English: It is recommended that left ventricular ejection fraction (LVEF) is assessed by echocardiogram or multi-gated acquisition (MUGA) scan before initiation of encorafenib and binimetinib, one month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
Slovenian: Priporočeno je, da se pred začetkom uporabe enkorafeniba in binimetiniba oceni iztisni delež levega prekata (LVEF) z ehokardiogramom ali slikanjem MUGA (multi-gated acquisition scan), nato en mesec po začetku uporabe in nato v približno 3-mesečnih intervalih ali pogosteje, kakor je klinično indicirano, v času trajanja zdravljenja.
English: For additional information on warnings and precautions associated with binimetinib treatment, see section 4.4 of binimetinib SmPC.
Slovenian: Za dodatne informacije o opozorilih in varnostnih ukrepih, povezanih z zdravljenjem z binimetinibom, glejte poglavje 4.4 Povzetka glavnih značilnosti zdravila binimetinib.
English: Blood alkaline phosphatase increased
Slovenian: Zvišana vrednost alkalne fosfataze v krvi
English: Most events were mild-moderate: Grade 1 in 12.4% (27/217) of patients, Grade 2 in 26.7% (58/217) and Grade 3 in 12.4% (27/217) of patients.
Slovenian: Večina dogodkov je bila blagih do zmernih: 1. stopnje pri 12,4 % (27/217) bolnikov; 2. stopnje pri 26,7 % (58/217) in 3. stopnje pri 12,4 % (27/217) bolnikov.
English: Women of childbearing potential / Contraception in females Women of childbearing potential must use effective contraception during treatment with encorafenib and for at least 1 month following the last dose.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z enkorafenibom in vsaj še 1 mesec po zadnjem odmerku.
English: Medicinal product interactions
Slovenian: Interakcije zdravila
English: The mean (CV%) apparent clearance (CL/F) of encorafenib was 27.9 L/h (9.15%).
Slovenian: enkorafeniba je bila 27,9 l/h (9,15 %).
English: - Liver problems: Braftovi can cause abnormal blood tests related to how your liver works (raised levels of liver enzymes).
Slovenian: - Težave z jetri: Zdravilo Braftovi lahko povzroči nenormalne rezultate krvnih preiskav delovanja jeter (povišane ravni jetrnih encimov v krvi).
English: Your doctor will check that your heart is working properly before and during your treatment with these medicines.
Slovenian: Zdravnik bo pred zdravljenjem s temi zdravili in med njim preveril, ali vaše srce deluje pravilno.
English: Transaminase increased* Blood creatinine increased* Lipase increased
Slovenian: Zvišana vrednost transminaze* Zvišana vrednost kreatinina v krvi* Zvišana vrednost lipaze
English: Visual impairment* RPED *
Slovenian: Okvara vida* RPED *
English: No dosing recommendation can be made in patients with moderate or severe hepatic impairment (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih z zmerno ali hudo jetrno okvaro se ne more dati priporočil glede odmerkov (glejte poglavji 4.2 in 4.4).
English: Encorafenib suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K).
Slovenian: Enkorafenib zatre pot kinaz RAF/MEK/ERK v tumorskih celicah z več mutiranimi oblikami kinaze BRAF (V600E,
English: Encorafenib and binimetinib (a MEK inhibitor, see section 5.1 of binimetinib SmPC) both inhibit the MAPK pathway, resulting in higher anti-tumour activity.
Slovenian: Enkorafenib in binimetinib (zaviralec MEK, glejte poglavje 5.1 Povzetka glavnih značilnosti zdravila binimetiniba) zavirata pot MAPK, kar pomeni večjo protitumorsko aktivnost.
English: The PFS for encorafenib 300 mg orally daily used in combination with binimetinib 45 mg orally twice daily (Combo 300, n = 258) was compared to the PFS for Enco 300 (n = 280, including 194 patients from Part 1 and 86 patients from Part 2).
Slovenian: Vrednost PFS pri peroralnem jemanju 300 mg enkorafeniba dnevno v kombinaciji s peroralnim jemanjem 45 mg binimetiniba dvakrat dnevno (kombinacija 300, n = 258) se je primerjala z vrednostjo PFS pri Enko 300 (n = 280, vključujoč 194 bolnikov iz 1. dela in 86 bolnikov iz 2. dela).
English: Capsule content
Slovenian: Vsebina kapsule
English: The median age of patients was 56 years (range 20-89), 58% were male, 90% were Caucasian, and 72% of patients had baseline ECOG performance status of 0.
Slovenian: Mediana starosti bolnikov je bila 56 let (od 20 do 89), 58 % bolnikov je bilo moških, 90 % belcev in
English: Printing ink
Slovenian: Črnilo za tisk
English: Based on a population pharmacokinetic analysis, body weight was found to be a significant model covariate on clearance and volume of distribution.
Slovenian: Glede na populacijsko farmakokinetično analizo je telesna masa pomembna sočasna spremenljivka modela za očistek in volumen distribucije.
English: Examples of moderate CYP3A4 inhibitors include, but are not limited to, amiodarone, erythromycin, fluconazole, diltiazem, amprenavir and imatinib.
Slovenian: Primeri zmernih inhibitorjev encima CYP3A4 med drugim vključujejo amiodaron, eritromicin, flukonazol, diltiazem, amprenavir in imatinib.
English: Blood creatinine increased* Amylase increased Lipase increased
Slovenian: Zvišana vrednost kreatinina v krvi* Zvišana vrednost amilaze Zvišana vrednost lipaze
English: If binimetinib is permanently discontinued, encorafenib should be discontinued.
Slovenian: Če je vnos binimetiniba trajno prekinjen, se mora jemanje enkorafeniba prekiniti.
English: • Grade 3
Slovenian: • 3. stopnja
English: Haemorrhagei Hypertension *
Slovenian: Krvavitevi Hipertenzija*
English: When encorafenib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Slovenian: Če se enkorafenib aplicira sočasno z zmernim inhibitorjem encima CYP3A, je treba varnost bolnikov pozorno spremljati.
English: There are no clinical data with encorafenib in patients with severe renal impairment.
Slovenian: Klinični podatki o uporabi enkorafeniba pri bolnikih s hudo ledvično okvaro niso na voljo.
English: In the pooled Combo 450 population, photosensitivity was observed in 4.0% (11/274) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bil pojav fotosenzitivnosti ugotovljen pri 4,0 % (11/274) bolnikov.
English: If one of these toxicities occurs, see section 4.2 of binimetinib SmPC for dose modification instructions for binimetinib.
Slovenian: Če se pojavi eden od teh toksičnih učinkov, glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila binimetinib, kjer so navedena navodila za spreminjanje odmerka binimetiniba.
English: Concurrent use of strong CYP3A inhibitors during treatment with encorafenib should be avoided.
Slovenian: Sočasnemu dajanju močnih inhibitorjev CYP3A se je med zdravljenjem z enkorafenibom treba izogibati.
English: Other skin cancers: Treatment with Braftovi may result in a different type of skin cancer such as cutaneous squamous cell carcinoma.
Slovenian: Druge vrste kožnega raka: Zdravljenje z zdravilom Braftovi lahko povzroči druge vrste kožnega raka,
English: Examples of moderate or strong CYP3A4 inducers include, but are not limited to carbamazepine, rifampicin, phenytoin and St. John's Wort.
Slovenian: Primeri zmernih ali močnih induktorjev encima CYP3A4 med drugim vključujejo karbamazepin, rifampicin, fenitoin in šentjanževko.
English: HRa (95% CI) (vs Vem)
Slovenian: HRa (95 % IZ) (proti Vem)
English: At the recommended dose (n = 274) in patients with unresectable or metastatic melanoma, the most common adverse reactions (>25%) occurring in patients treated with encorafenib administered with binimetinib were fatigue, nausea, diarrhoea, vomiting, retinal detachment, abdominal pain, arthralgia, blood CK increased and myalgia.
Slovenian: Ob priporočenem odmerku enkorafeniba v kombinaciji z binimetinibom pri bolnikih (n = 274) z neresektabilnim ali metastatskim melanomom so bili najpogostejši neželeni učinki (> 25 %) utrujenost, slabost, driska, bruhanje, odstop mrežnice, bolečine v trebuhu, artralgija, povečana količina CK v krvi in bolečine v mišicah.
English: • Increased transaminases: 15.7% (43/274) overall - Grade 3-4: 5.5% (15/274)
Slovenian: • Povečana raven transaminaze: skupno 15,7 % (43/274) - 3.-4. stopnje: 5,5 % (15/274)
English: Patients receiving encorafenib should undergo a head and neck examination, chest/abdomen computerised tomography (CT) scan, anal and pelvic examinations (for women) and complete blood cell counts prior to initiation, during and at the end of treatment as clinically appropriate.
Slovenian: Bolnikom je treba pred in med zdravljenjem z enkorafenibom ter po njem pregledati glavo in vrat, opraviti računalniško tomografijo (CT) prsnega koša/trebuha, pregled zadnjika in ginekološki pregled (pri ženskah) in celotno krvno sliko, kot je klinično primerno.
English: If uveitis is Grade 1 and it improves to Grade 0, then treatment should be resumed at the same dose.
Slovenian: Če je vnetje uvee 1. stopnje in se izboljša na stopnjo 0, je treba nadaljevati zdravljenje z enakim odmerkom.
English: Agents that are CYP3A4 substrates should be co-administered with caution.
Slovenian: Učinkovine, ki so substrati encima CYP3A4, je treba sočasno aplicirati previdno.
English: Suspicious skin lesions should be managed with dermatological excision and dermatopathologic evaluation.
Slovenian: Vsako sumljivo lezijo na koži je treba izrezati in poslati na histopatološko oceno.
English: Figure 1 Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date: 19 May 2016)
Slovenian: Slika 1: Študija CMEK162B2301, 1. del: Grafikon po Kaplan-Meierjevem modelu preživetja brez napredovanja glede na podatke neodvisnega centralnega pregleda (končni datum 19. maj 2016)
English: In the pooled Combo 450 population, cuSCC including keratoacanthomas was observed in 3.3% (9/274) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bil pojav cuSCC, vključno s keratoakantomi, opažen pri 3,3 % (9/274) bolnikov.
English: In case of vomiting after administration of encorafenib, the patient should not take an additional dose and should take the next scheduled dose.
Slovenian: Če bolnik po vnosu enkorafeniba bruha, ne sme vzeti dodatnega odmerka, ampak mora naslednji odmerek vzeti po običajnem urniku.
English: If uveitis is Grade 2 or 3 and it improves to Grade 0 or 1, then treatment should be resumed at a reduced dose.
Slovenian: Če je vnetje uvee 2. ali 3. stopnje in se izboljša na stopnjo 0 ali 1. stopnjo, je treba nadaljevati zdravljenje z zmanjšanim odmerkom.
English: Cutaneous reactions • Grade 2
Slovenian: Kožne reakcije • 2. stopnja
English: erythromycin, penicillin) - medicines typically used to treat epilepsy (seizures) (such as phenytoin, carbamazepine) - medicines typically used to treat cancer (such as methotrexate, imatinib) - medicines typically used to treat high cholesterol (such as rosuvastatin, atorvastatin) - an herbal treatment for depression: St. John's wort - some medicines for HIV treatment such as ritonavir, amprenavir, raltegravir, dolutegravir - birth control medicines containing hormones - medicines typically used to treat high blood pressure (such as diltiazem, bosentan, furosemide) - a medicine used to treat an uneven heartbeat: amiodarone.
Slovenian: - zdravila, ki se običajno uporabljajo za zdravljenje epilepsije (epileptičnih napadov) (kot sta fenitoin, karbamazepin), - zdravila, ki se običajno uporabljajo za zdravljenje raka (kot sta metotreksat, imatinib), - zdravila, ki se običajno uporabljajo za zdravljenje povišanih vrednosti holesterola (kot sta rosuvastatin, atorvastatin), - rastlinsko zdravilo za depresijo: šentjanževka, - nekatera zdravila za zdravljenje okužbe z virusom HIV kot so ritonavir, amprenavir, raltegravir,
English: The occurrence of Grade ≥3 haemorrhagic events should be managed with dose interruption or treatment discontinuation (see Table 3 in section 4.2) and as clinically indicated.
Slovenian: Pojav krvavitev 3. ali višje stopnje je treba nadzirati s prekinitvijo vnosa ali popolnim prenehanjem zdravljenja (glejte preglednico 3 v poglavju 4.2) in kakor je klinično indicirano.
English: Patients with mild to severe hepatic impairment may have increased encorafenib exposure (see section 5.2).
Slovenian: Bolniki z blago do hudo jetrno okvaro so lahko bolj izpostavljeni enkorafenibu (glejte poglavje 5.2).
English: Renal failure events, including acute kidney injury and renal impairment, were reported in 3.3% (9/274) patients treated with encorafenib and binimetinib with Grade 3 or 4 events in 2.2% (6/274) of patients.
Slovenian: vključno z akutno poškodbo ledvic in ledvično okvaro, so bili opaženi pri 3,3 % (9/274) bolnikov, zdravljenih z enkorafenibom in binimetinibom, pri čemer je pri 2,2 % (6/274) šlo za dogodke 3. ali 4. stopnje.
English: Encorafenib should be withheld until improved to Grade 0 or 1 and resumed at the same dose if first occurrence, or resumed at a reduced dose if recurrent Grade 3.
Slovenian: Vnašanje enkorafeniba je treba prekiniti, dokler se stanje ne izboljša do stopnje 0 ali 1. stopnje, ter nato nadaljevati z enakim odmerkom, če je šlo za prvo pojav, oziroma z zmanjšanim odmerkom, če je šlo za ponovitev neželenega učinka 3. stopnje.
English: If encorafenib is permanently discontinued, then binimetinib should be discontinued.
Slovenian: Če je vnos enkorafeniba trajno prekinjen, je treba prekiniti vnos binimetiniba.
English: • Increased GGT: 14.0% (36/257) overall - Grade 3-4: 4.7% (12/257)
Slovenian: • Povečana vrednost GGT: skupno 14,0 % (36/257) - 3.-4. stopnje: 4,7 % (12/257)
English: Constipation occurred in 24.1% (66/274) of patients and was Grade 1 or 2.
Slovenian: Do zaprtja je prišlo pri 24,1 % (66/274) bolnikov in je doseglo 1. ali 2. stopnjo.
English: Gelatin (E441) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Slovenian: Želatina (E441) Titanov dioksid (E171) Rdeči železov oksid (E172) Rumeni železov oksid (E172) Črni železov oksid (E172)
English: In the pooled encorafenib 300 population, new primary melanoma events occurred in 4.1% of patients (9 /217) and was reported as Grade 1 in 1.4% (3/217) of patients, Grade 2 in 2.1% (4/217) of patients, Grade 3 in 0.5% (1/217) of patients and Grade 4 in 0.5% (1/217) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja z enkorafenibom 300, je bil pojav novih primarnih melanomov opažen pri 4,1 % (9/217) bolnikov, in sicer 1. stopnje pri 1,4 % (3/217) bolnikov, 2. stopnje pri 2,1 % (4/217) bolnikov, 3. stopnje pri 0,5 % (1/217) bolnikov in 4. stopnje pri 0,5 % (1/217) bolnikov.
English: Neuropathy peripheral* Dysgeusia*
Slovenian: Periferna nevropatija* Disgevzija*
English: Abdominal pain was reported in 27.4% (75/274) of patients and was Grade 3 in 2.6% (7/274) patients.
Slovenian: Abdominalne bolečine so bile opažene pri 27,4 % (75/274) bolnikov in so dosegle 3. stopnjo pri 2,6 % (7/274) bolnikov.
English: The Functional Assessment of Cancer Therapy-Melanoma (FACT-M), the European Organisation for Research and Treatment of Cancer's core quality of life questionnaire (EORTC QLQ-C30) and the EuroQoL-5 Dimension-5 Level examination (EQ-5D-5L) were used to explore patient-reported outcomes (PRO) measures of health-related Quality of Life, functioning, melanoma symptoms, and treatment-related adverse reactions.
Slovenian: Kakovost življenja (QoL) (končni datum: 19. maj 2016) Za raziskovanje meritev rezultatov, o katerih so bolniki poročali glede kakovosti življenja in funkcionalnega stanja v povezavi z zdravjem in simptomov melanoma ter neželenih učinkih v povezavi z zdravljenjem, so se uporabili ocena funkcionalnosti zdravljenja raka - melanom (FACTM), glavni vprašalnik o kakovosti življenja Evropske organizacije za raziskave in zdravljenje raka (EORTC QLQ-C30) in 5-dimenzijski 5-stopenjski vprašalnik EuroQoL (EQ-5D-5L).
English: Gamma-glutamyl transferase (GGT) increased* Transaminase increased*
Slovenian: Zvišana vrednost gamaglutamiltransferaze (GGT)* Zvišana vrednost transminaze*
English: Dermatitis acneiform
Slovenian: Akneiformni dermatitis
English: RPED occurred in 29.6% (81/274) of patients, most of them had Grade 1-2 and 1.8% (5/274) had Grade 3 events.
Slovenian: RPED so opazili pri 29,6 % (81/254) bolnikov, pri čemer je pri večini prišlo do dogodka 1.-2. stopnje, pri 1,8 % (5/274) bolnikov pa do dogodka 3. stopnje.
English: Pancreatitis*
Slovenian: Pankreatitis*
English: Additionally, the combination of encorafenib and binimetinib prevented the emergence of resistance in BRAFV600E mutant human melanoma xenografts in vivo.
Slovenian: Poleg tega je kombinacija enkorafeniba in binimetiniba pri in vivo preskušanjih človeških ksenograftov z melanomom z mutacijo BRAFV600E preprečila pojavitev odpornosti proti zdravljenju.
English: Overall, results suggest that single agent encorafenib has the potential to cause mild increases in heart rate.
Slovenian: Na splošno pa rezultati kažejo, da lahko zdravljenje z enkorafenibom kot samostojnim zdravilom povzroči blago povišanje srčnega utripa.
English: Most events were mild-moderate: Grade 1 in 2.3% (5/217); Grade 2 in 3.7% (8/217) and Grade 3 in 1.4% (3/217) of patients.
Slovenian: Večina dogodkov je bila blagih do zmernih: 1. stopnje pri 2,3 % (5/217) bolnikov, 2. stopnje pri 3,7 % (8/217) in 3. stopnje pri 1,4 % (3/217) bolnikov.
English: Arthritis *
Slovenian: Artritis*
English: Effect of encorafenib on transporters
Slovenian: Učinek enkorafeniba na prenašalce
English: HRa (95% CI) (vs Enco 300)
Slovenian: HRa (95 % IZ) (proti Enko 300)
English: In the pooled Combo 450 population, mild, mostly Grade 1, asymptomatic blood creatinine elevation was noted in 6.2% (17/274) of patients treated with the Combo 450 mg.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 so poročali o blagem dvigu kreatinina v krvi, večinoma 1. stopnje, pri 6,2 % (17/274) bolnikov, ki so jemali kombinacijo 450 mg.
English: The most common adverse drug reactions (ADRs) (>25%) reported with encorafenib 300 were hyperkeratosis, alopecia, PPES, fatigue, rash, arthralgia, dry skin, nausea, myalgia, headache, vomiting and pruritus.
Slovenian: Med najpogostejšimi neželenimi učinki zdravila (NUZ) (> 25 %), o katerih so poročali v zvezi z enkorafenibom 300, so bili hiperkeratoza, alopecija, sindrom roka-noga, utrujenost, izpuščaj, artralgija, suha koža, slabost,
English: Most events were mild, with Grade 3 or 4 events reported in 0.7% (2/274) of patients.
Slovenian: Večina dogodkov je bila za blagih, o dogodkih 3. ali 4. stopnje pa so poročali pri 0,7 % (2/274) bolnikov.
English: If encorafenib is used during pregnancy or if the patient becomes pregnant while taking encorafenib, the patient should be informed of the potential hazard to the foetus.
Slovenian: Če bolnica jemlje enkorafenib med nosečnostjo ali med jemanjem enkorafeniba zanosi,
English: If no improvement within 4 weeks, encorafenib should be withheld until improved to Grade 0 or 1 or to pretreatment/baseline levels and then resumed at the same dose.
Slovenian: Če se v 4 tednih stanje ne izboljša, je treba vnašanje enkorafeniba prekiniti, dokler ni doseženo izboljšanje do stopnje 0 ali 1. stopnje oziroma vrednosti pred zdravljenjem/izhodiščnih vrednosti, nato je treba nadaljevati z enakim odmerkom.
English: When encorafenib was used at a dose of 300 mg once daily in combination with binimetinib 45 mg twice daily (Combo 300) in study CMEK162B2301-Part 2, the frequency category was lower compared to the pooled Combo 450 population for the following adverse reactions: anemia, peripheral neuropathy, haemorrhage, hypertension, pruritus (common); and colitis, increased amylase and increased lipase (uncommon).
Slovenian: Ko se je enkorafenib uporabljal pri odmerku 300 mg enkrat na dan v kombinaciji z odmerkom 45 mg binimetiniba dvakrat na dan (kombinacija 300) v 2. delu študije CMEK162B2301, je bila pogostnost nižja v primerjavi z združeno populacijo bolnikov v okviru zdravljenja s kombinacijo 450 za naslednje neželene učinke: anemija, periferna nevropatija, krvavitve, hipertenzija, srbenje (pogosti); in kolitis,
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, the incidence of liver laboratory abnormalities was:
Slovenian: V 2. delu študije CMEK162B2301 je bila pri bolnikih v okviru zdravljenja s kombinacijo 300 pogostnost nenormalnih laboratorijskih izvidov delovanja jeter naslednja:
English: If not improved despite supportive therapy within 2 weeks, encorafenib should be withheld until improved to Grade 0 or 1 and treatment should be resumed at same dose level or at a reduced dose.
Slovenian: Če kljub podporni terapiji v 2 tednih ni izboljšanja, je treba vnašanje enkorafeniba prekiniti, dokler se stanje ne izboljša do stopnje 0 ali 1. stopnje, ter nato nadaljevati zdravljenje z enakim oziroma z zmanjšanim odmerkom.
English: Your doctor will run blood tests to check your liver before and during treatment.
Slovenian: Zdravnik bo pred zdravljenjem in med njim opravil preiskave krvi in tako preveril delovanje vaših jeter.
English: • Capsule shell: gelatin (E441), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)
Slovenian: • Ovojnica kapsule: želatina (E441), titanov dioksid (E171), rdeči železov oksid (E172), rumeni železov oksid (E172), črni železov oksid (E172)
English: Neuropathy peripheral* Dizziness*
Slovenian: Periferna nevropatija* Omotica*
English: Moderate CYP3A4 inhibitors should be co-administered with caution.
Slovenian: Zmerne inhibitorje encima CYP3A4 je treba sočasno aplicirati previdno.