FrancophonIA/ELRC3.0 huggingface dataset:
English: Birth control medicines containing hormones (such as pills, injections, patches, implants and certain intrauterine devices (IUDs) that release hormones) may not work as well as expected while you are taking Braftovi.
Slovenian: Kontraceptivi, ki vsebujejo hormone (kot so tablete, injekcije, obliži, vsadki in nekateri maternični vložki (IUD), ki sproščajo hormone), morda med jemanjem zdravila Braftovi ne bodo delovali tako zanesljivo, ko je pričakovano.
English: Encorafenib should be withheld for up to 4 weeks.
Slovenian: Vnašanje enkorafeniba je treba prekiniti za do 4 tedne.
English: Panniculitis* Photosensitivity*
Slovenian: Panikulitis* Fotosenzitivnost*
English: If you have liver or kidney problems, your doctor may start you on a lower dose.
Slovenian: Če imate težave z ledvicami ali jetri, vam zdravnik za začetek lahko predpiše manjši odmerek.
English: • Recurrent or intolerable Grade 2 adverse reactions
Slovenian: • Ponavljajoči ali nevzdržni neželeni učinki 2. stopnje
English: Most patients had metastatic disease (95%) and were Stage IVM1c (64%); 27% of patients had elevated baseline serum lactate dehydrogenase (LDH), and 45% of patients had at least 3 organs with tumour involvement at baseline and 3.5% had brain metastases.
Slovenian: Večina bolnikov je imela metastatsko bolezen (95 %) in stadij IVM1c (64 %); 27 % bolnikov je imelo povišano izhodiščno vrednost serumske laktat dehidrogenaze (LDH), 45 % bolnikov je imelo najmanj 3 organe s tumorji v izhodišču in 3,5 % jih je imelo možganske metastaze.
English: • Grade 1-3
Slovenian: • 1.-3. stopnja
English: Dose reduction recommendations for encorafenib are presented in Table 1.
Slovenian: Priporočila za zmanjšanje odmerka enkorafeniba so navedena v preglednici 1.
English: Therefore, concomitant administration of encorafenib with strong CYP3A4 inhibitors should be avoided (due to increased encorafenib exposure and potential increase in toxicity, see section 5.2).
Slovenian: Zato se je treba sočasnemu vnosu enkorafeniba z močnimi inhibitorji encima CYP3A4 izogibati (zaradi povečane izpostavljenosti enkorafenibu in morebitne povečane toksičnosti, glejte poglavje 5.2).
English: 450 mg once daily
Slovenian: 300 mg enkrat dnevno
English: Other medicines and Braftovi
Slovenian: Druga zdravila in zdravilo Braftovi
English: However, given the small magnitude of change in clearance and the high variability in the predicted volume of distribution in the model, weight is unlikely to have a clinically relevant influence on the exposition of encorafenib.
Slovenian: Vseeno pa ima zaradi majhne magnitude sprememb v očistku in visoke variabilnosti napovedanega volumna distribucije v modelu masa malo verjetno klinično pomemben vpliv na izpostavljenost enkorafenibu.
English: The risk of haemorrhage may be increased with concomitant use of anticoagulant and antiplatelet therapy.
Slovenian: Tveganje za pojav krvavitev se poveča ob sočasnem zdravljenju z antikoagulacijskimi in antiagregacijskimi zdravili.
English: The median duration of treatment was longer for Combo 300 vs Enco 300, 52.1 weeks vs 31.5 weeks.
Slovenian: Vrednost mediane trajanja zdravljenja je bila večja za kombinacijo 300 v primerjavi z Enko 300, in sicer 52,1 tedna v primerjavi z 31,5 tedna.
English: In the sub-acute 28-day and sub-chronic 13-week rat toxicology studies, encorafenib treatment at 20 mg/kg/d (dose level approximately 8 times the human exposure at the recommended dose) resulted in decreased testes and epididymis weights with tubular degeneration and oligospermia.
Slovenian: V subakutni 28-dnevni in subkronični 13-tedenski študiji toksičnosti pri podganah je zdravljenje z enkorafenibom z odmerkom 20 mg/kg/d (raven odmerka je približno 8-kratnik vrednosti za izpostavljenost ljudi pri priporočenem odmerku) povzročilo zmanjšane testise in epididimis z degeneracijo tubulov in oligospermijo.
English: Colitis k
Slovenian: Kolitis k
English: This is a precaution in case a squamous cell carcinoma develops inside your body.
Slovenian: Gre za previdnostni ukrep v primeru, da bi se vam v telesu razvijal ploščatocelični karcinom kože.
English: Results from a dedicated clinical study indicate a 25% higher total encorafenib exposures in patients with mild hepatic impairment (Child-Pugh Class A) compared with subjects with normal liver function.
Slovenian: Rezultati namenskih kliničnih študij navajajo 25 % višjo celokupno izpostavljenost enkorafenibu pri bolnikih z milejšo okvaro jeter (Child-Pugh razreda A) v primerjavi z udeleženci z normalno jetrno funkcijo.
English: Symptomatic treatment and supportive care should be provided as needed.
Slovenian: Po potrebi se izvede zdravljenje simptomov in podporna nega.
English: Therefore, in these patients, binimetinib should be used with caution and for any symptomatic left ventricular dysfunction, Grade 3-4 LVEF or for absolute decrease of LVEF from baseline of ≥ 10%, binimetinib and encorafenib should be discontinued and LVEF should be evaluated every 2 weeks until recovery.
Slovenian: Zato je pri teh bolnikih binimetinib treba uporabljati previdno, v primeru simptomatične disfunkcije levega prekata, LVEF 3. ali 4. stopnje ali pri absolutnem zmanjšanju LVEF z izhodiščne vrednosti ≥ 10 %, je treba prenehati uporabo binimetiniba in enkorafeniba in ocenjevati LVEF vsaka dva tedna do okrevanja.
English: Encorafenib was found to be a substrate of the P-glycoprotein (P-gp) transporters.
Slovenian: Ugotovljeno je bilo, da je enkorafenib substrat prenašalcev P-glikoproteina (P-gp).
English: Braftovi is not recommended during pregnancy.
Slovenian: Zdravilo Braftovi se ne priporoča med nosečnostjo.
English: An additional secondary endpoint included PFS of Combo 450 compared with Enco 300.
Slovenian: Dodatna sekundarna končna točka je vključevala PFS pri zdravljenju s kombinacijo 450 v primerjavi z Enko 300.
English: If you are a woman who could become pregnant, you must use reliable contraception while you are taking Braftovi, and you must continue to use reliable contraception for at least 1 month after taking your last dose.
Slovenian: Če ste ženska z možnostjo zanositve, morate med jemanjem zdravila Braftovi uporabljati zanesljivo kontracepcijo, ki jo morate uporabljati še vsaj 1 mesec po tem, ko vzamete zadnji odmerek.
English: Administration of a single 100 mg dose of encorafenib with a highfat, high-calorie meal decreased the Cmax by 36%, while the AUC was unchanged.
Slovenian: Uporaba enojnega odmerka 100 mg enkorafeniba ob obroku, bogatem z maščobami in kalorijami, zmanjša Cmax za 36 %, pri čemer AUC ostane nespremenjena.
English: Encorafenib should be resumed at a reduced dose when QTcF ≤500 ms.
Slovenian: Vnašanje zmanjšanega odmerka enkorafeniba je treba nadaljevati, ko je dosežena vrednost QTcF ≤ 500 ms.
English: If not improved within 6 weeks, ophthalmic monitoring should be repeated and encorafenib should be permanently discontinued.
Slovenian: Če v 6 tednih ni izboljšanja, je treba ponoviti oftalmološke preglede in trajno prekiniti vnos enkorafeniba.
English: After repeat once-daily dosing, steady-state conditions were reached within 15 days.
Slovenian: Po večkratnem odmerjanju enkrat na dan je bilo stanje dinamičnega ravnovesja doseženo v 15 dneh.
English: Contents of the pack and other information What Braftovi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Braftovi
English: Treatment should continue until the patient no longer derives benefit or the development of unacceptable toxicity.
Slovenian: Zdravljenje naj traja toliko časa, dokler ima bolnik od njega še koristi oziroma dokler se ne razvije nesprejemljiva toksičnost.
English: Other major metabolic pathways involved hydroxylation, carbamate hydrolysis, indirect glucuronidation and glucose conjugate formation.
Slovenian: Ostale glavne metabolne poti vključujejo hidroksilacijo, hidrolizo karbamata, neposredno glukuronidacijo in tvorjenje konjugata z glukozo.
English: Effects of other medicinal products on encorafenib Encorafenib is primarily metabolised by CYP3A4.
Slovenian: Vplivi drugih zdravil na enkorafenib Enkorafenib se primarno metabolizira s CYP3A4.
English: However if the missed dose is more than 12 hours late, skip that dose and take your next dose at the usual time.
Slovenian: Če pa s pozabljenim odmerkom zamujate več kot 12 ur, ta odmerek preskočite in vzemite naslednjega ob običajnem času.
English: Encorafenib should be withheld, supportive measures such as topical therapy should be instituted, and the patient should be reassessed weekly.
Slovenian: Vnašanje enkorafeniba je treba prekiniti in uvesti podporne ukrepe, kot je topično zdravljenje, in tedensko preverjati stanje bolnika.
English: Besides the serious side effects mentioned above, people taking Braftovi may also get other side effects.
Slovenian: Poleg zgoraj navedenih resnih neželenih učinkov se lahko pri bolnikih, ki jemljejo zdravilo Braftovi, pojavijo še drugi neželeni učinki.
English: Unstratified subgroup analyses demonstrated point estimates in favour of Combo 450, including LDH at baseline, ECOG performance status and AJCC stage.
Slovenian: Nestratificirane analize podskupin so pokazale ocenjene vrednosti v korist kombinaciji 450, vključno pri izhodiščni vrednosti encima LDH, stanju zmogljivosti ECOG in stadiju po AJCC.
English: CK elevation and rhabdomyolysis
Slovenian: Dvig CK in rabdomioliza
English: When Braftovi is used in combination with binimetinib, which targets another protein that stimulates cancer cell growth, the combination slows down or stops the growth of your cancer.
Slovenian: Ko se zdravilo Braftovi uporabi v kombinaciji z binimetinibom, ki deluje na drug protein, ki spodbuja rast rakavih celic, ta kombinacija upočasni ali zaustavi rast rakavih celic.
English: Other secondary efficacy comparisons between Combo 450 and either vemurafenib or Enco 300 included overall survival (OS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR) as assessed by BIRC and by investigator assessment.
Slovenian: Druge primerjave sekundarne učinkovitosti med kombinacijo 450 in vemurafenibom ali Enko 300 so vključevale celokupno preživetje (overall survival - OS), objektivno stopnjo odziva (objective response rate - ORR), trajanje odziva (duration of response - DoR) in stopnjo nadzora bolezni (disease control rate - DCR), kot so jih ocenili odbor BIRC in raziskovalci.
English: Non-cutaneous malignancies Based on its mechanism of action, encorafenib may promote malignancies associated with activation of RAS through mutation or other mechanisms.
Slovenian: Na podlagi svojega mehanizma delovanja lahko enkorafenib povzroči malignome, povezane z aktivacijo gena RAS zaradi mutacije ali drugih mehanizmov.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE46
Slovenian: Farmakoterapevtska skupina:zdravilo z delovanjem na novotvorbe (citostatik), zaviralec proteinskih kinaz, oznaka ATC: L01XE46
English: For new primary non-cutaneous RAS mutation-positive malignancies: it should be considered to discontinue encorafenib and binimetinib permanently.
Slovenian: Za nove primarno nedermalne malignome, pozitivne na mutacijo RAS: razmisliti je treba o trajni prekinitvi vnosa enkorafeniba in binimetiniba.
English: This observation was similar to that described in humans as central serous-like chorioretinopathy or central serous retinopathy.
Slovenian: To opažanje je podobno tistemu, opisanemu pri ljudeh kot centralna serozna horioretinopatija ali centralna serozna retinopatija.
English: In particular, tell your doctor if you are taking anything in this list or any other medicines: - some medicines to treat fungal infections (such as itraconazole, posaconazole, fluconazole) - some medicines to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin,
Slovenian: Še posebej zdravnika opozorite, če jemljete katero izmed v spodnjem seznamu navedenih zdravil ali katero koli drugo zdravilo: - nekatera zdravila za zdravljenje glivičnih okužb (kot so itrakonazol, posakonazol, flukonazol), - nekatera zdravila za zdravljenje bakterijskih okužb (kot so rifampicin, klaritromicin,
English: Braftovi is for oral use.
Slovenian: Zdravilo Braftovi je za peroralno uporabo.
English: It is unknown whether encorafenib or its metabolites are excreted in human milk.
Slovenian: Dojenje Ni znano, ali se enkorafenib oziroma njegovi metaboliti izločajo v materino mleko.
English: When Braftovi was used on its own in clinical trials
Slovenian: Ko se je se zdravilo Braftovi v kliničnih preskušanjih uporabljalo samostojno
English: The median (range) encorafenib terminal half-life (T1/2) was 6.32 h (3.74 to 8.09 h).
Slovenian: Srednja vrednost (obseg) končne razpolovne dobe enkorafeniba (T1/2) je bila 6,32 h (od 3,74 do 8,09h).
English: The median time to onset of the first event of cuSCC (all grades) was 6.5 months (range 1.0 to 22.8 months).
Slovenian: Mediana časa do prvega pojava cuSCC (vse stopnje) je bila 6,5 meseca (v razponu od 1,0 do 22,8 meseca).
English: Part 2 of Study CMEK162B2301 was designed to assess the contribution of binimetinib to the encorafenib and binimetinib combination.
Slovenian: 2. del študije CMEK162B2301 je bil zasnovan z namenom vrednotenja doprinosa binimetiniba v kombinaciji enkorafeniba in binimetiniba.
English: At doses of encorafenib between 600 to 800 mg once daily, renal dysfunction (Grade 3 hypercreatinaemia) was observed in 3 out of 14 patients.
Slovenian: Pri odmerkih enkorafeniba med 600 in 800 mg enkrat dnevno je bila okvara ledvic (hiperkreatinemija 3. stopnje) opažena pri 3 od 14 bolnikov.
English: Gastrointestinal disorders were typically managed with standard therapy.
Slovenian: Bolezni prebavil so bile večinoma obvladovane s standardnim zdravljenjem.
English: Visual impairment, including blurred vision and reduced visual acuity, occurred in 21.5% (59/274) of patients.
Slovenian: Okvara vida, vključno z zamegljenim vidom in zmanjšano ostrino vida, je bila opažena pri 21,5 % (59/274) bolnikov.
English: Braftovi is an anti-cancer medicine that contains the active substance encorafenib.
Slovenian: Braftovi je zdravilo proti raku, ki vsebuje zdravilno učinkovino enkorafenib.
English: In the 4-week and 13-week rat toxicity studies, clinical signs, reduced body weight reduced epididymides and prostate weights and microscopic findings in testes, epididymides, stomach and skin were noted.
Slovenian: V 4-tedenskih in 13-tedenskih študijah toksičnosti pri podganah so bili opaženi naslednji klinični znaki: zmanjšana telesna masa, zmanjšana epididimis in masa prostate ter mikroskopske sledi v testisih, epididimisu, trebuhu in na koži.
English: An analysis of time to definitive 10% deterioration in EORTC QLQ-C30 score provided with similar results.
Slovenian: Analiza časa do dokončnega 10-odstotnega poslabšanja pri oceni z vprašalnikom EORTC QLQ-C30 je pokazala podobne rezultate.
English: Model-based predictions for ketoconazole suggest an increase of approx. 5-fold for encorafenib AUC and 3 to 4-fold for encorafenib Cmax.
Slovenian: Po napovedih na podlagi modela za ketokonazol se predvideva povečanje - približno 5-kratno za AUC enkorafeniba in od 3- do 4-kratno za Cmax enkorafeniba.
English: Patients had histologically confirmed cutaneous or unknown primary melanoma but those with uveal or mucosal melanoma were excluded.
Slovenian: Bolniki so imeli histološko potrjen kožni ali neznani primarni melanom, vendar so bili bolniki z uvealnim ali mukoznim melanomom izključeni.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom,
English: There is no known antidote for encorafenib.
Slovenian: Za enkorafenib ni znanega antidota.
English: Alternative agents with no or minimal CYP3A induction potential should be considered.
Slovenian: Razmisliti je treba o alternativnih učinkovinah z minimalno indukcijo encima CYP3A ali brez nje.
English: No overall differences in safety or efficacy were observed between elderly patients (≥ 65) and younger patients.
Slovenian: Med starejšimi (≥ 65 let) in mlajšimi bolniki skupno ni bilo opaženih razlik glede varnosti ali učinkovitosti.
English: In vitro, encorafenib inhibited the hepatic transporter OCT1, but is unlikely to be an effective inhibitor clinically.
Slovenian: In vitro je enkorafenib zavrl jetrnega prenašalca OCT1, vendar je malo verjetno, da bi bil klinično učinkovit inhibitor.
English: Dose modification
Slovenian: Sprememba odmerka
English: Ask your doctor, pharmacist or nurse for advice.
Slovenian: Za nasvet vprašajte zdravnika, farmacevta ali medicinsko sestro.
English: For new primary cutaneous malignancies: No dose modifications are required for encorafenib.
Slovenian: Za nove primarno dermalne malignome: odmerka enkorafeniba ni potrebno spreminjati.
English: Study CMEK162B2301, Part 1
Slovenian: Študija CMEK162B2301, 1. del
English: For co-administration with CYP3A4 and UGT1A1 substrates that undergo gut extraction, a minor to moderate interaction is expected.
Slovenian: Za skupno aplikacijo s substratoma CYP3A4 in UGT1A1, ki se absorbirata v črevesju, se pričakuje manjša do zmerna interakcija.
English: Additionally, in the 13-week rat toxicity study, reversible clinical pathology changes were noted at doses ≥ 100 mg/kg/d.
Slovenian: Poleg tega so bile v 13-tedenski študiji toksičnosti pri podganah pri odmerkih ≥ 100 mg/kg/d opažene reverzibilne spremembe klinične patologije.
English: - Eye problems: Braftovi, when taken with binimetinib, can cause serious eye problems.
Slovenian: - Težave z očmi: Zdravilo Braftovi, kadar se jemlje z binimetinibom, lahko povzroči resne težave z očmi.
English: A definitive 10% deterioration in FACT-M and in EORTC QLQC30 was significantly delayed in patients treated with Combo 450 relative to other treatments.
Slovenian: 10-odstotno dokončno poslabšanje pri oceni FACT-M in vprašalniku EORTC QLQ-C30 je bilo glede na druga zdravljenja bistveno zakasnjeno pri bolnikih, ki so se zdravili s kombinacijo 450.
English: In the absence of clinical data, encorafenib is not recommended in patients with moderate or severe hepatic impairment.
Slovenian: Zaradi pomanjkanja kliničnih podatkov uporaba enkorafeniba ni priporočljiva za bolnike z zmerno ali hudo jetrno okvaro.
English: Patients should ensure adequate fluid intake during treatment.
Slovenian: Med zdravljenjem morajo bolniki vnašati zadostne količine tekočin.
English: The recommended dose of Braftovi is 6 capsules of 75 mg once daily (corresponding to a daily dose of 450 mg).
Slovenian: Priporočeni odmerek zdravila Braftovi je 6 kapsul po 75 mg enkrat dnevno (kar ustreza dnevnemu odmerku 450 mg).
English: Most events were Grade 1 or 2 (14.6%) and 3.3% were Grade 3-4 events.
Slovenian: Večina dogodkov je bila 1. ali 2. stopnje (14,6 %), 3,3 % primerov pa je bilo 3. ali 4. stopnje.
English: Polyamide/aluminum/PVC/aluminum blister containing 6 capsules.
Slovenian: Poliamid/aluminij/PVC/aluminij pretisni omot s 6 kapsulami.
English: Study CMEK162B2301, Part 2:
Slovenian: Študija CMEK162B2301, 2. del:
English: The primary efficacy outcome measure was progression-free survival (PFS) of Combo 450 compared with vemurafenib as assessed by a blinded independent review committee (BIRC).
Slovenian: Meritev rezultata primarne učinkovitosti je bila preživetje brez napredovanja (progression-free survival - PFS) pri zdravljenju s kombinacijo 450 v primerjavi z vemurafenibom po ocenah neodvisnega slepega odbora za pregled (blinded independent review committee - BIRC).
English: Braftovi may reduce sperm count in males.
Slovenian: Zdravilo Braftovi lahko zmanjša število spermijev pri moških.
English: Side effects when Braftovi and binimetinib are taken together
Slovenian: Neželeni učinki, ko se zdravilo Braftovi in binimetinib jemljeta skupaj
English: Ophthalmic lesions were partially reversible and consisted of a separation or detachment in the retina between the outer rods and cones layer and retinal pigmented epithelium at the central macula at the fovea.
Slovenian: Očesne lezije so bile delno reverzibilne in so vključevale ločitev ali odstop v mrežnici med zunanjo plastjo paličic in čepkov in mrežničnega pigmentnega epitelija v centru rumene pege v fovei.
English: Polyamide/aluminum/PVC/aluminum blister containing 4 capsules.
Slovenian: Poliamid/aluminij/PVC/aluminij pretisni omot s 4 kapsulami.
English: Uveitis and visual impairment were generally reversible.
Slovenian: Vnetje uvee in okvare vida so bile večinoma reverzibilne.
English: Visual disturbances have been reported in some patients treated with encorafenib during clinical studies.
Slovenian: Poročali so o motnjah vida pri nekaterih bolnikih, ki so v kliničnih študijah jemali enkorafenib.
English: The highest administered dose occurred as a dosing error in one patient who took encorafenib at a dose of 600 mg twice daily for 1 day (total dose 1200 mg).
Slovenian: Najvišji vneseni odmerek je bil posledica napake pri določanju odmerka za enega bolnika, ki je 1 dan jemal dva 600-miligramska odmerka enkorafeniba dnevno (v skupnem odmerku 1200 mg).
English: The embryo-foetal development study in rabbits indicated that encorafenib induced foetal toxicity with lower foetal weights and transitory changes in skeletal development.
Slovenian: Embriofetalna razvojna študija pri zajcih navaja, da je enkorafenib povzročil fetalno toksičnost z nižjo težo fetusa in prehodne spremembe v skeletnem razvoju.
English: Observed cases of renal failure including acute kidney injury and renal impairment were generally associated with vomiting and dehydration.
Slovenian: Pri opaženih primerih okvare ledvic, vključno z akutno poškodbo ledvic in ledvično okvaro, sta se pogosto pojavila tudi bruhanje in dehidracija.
English: 28 hard capsules 112 hard capsules
Slovenian: 28 trdih kapsul 112 trdih kapsul
English: Encorafenib 450 mg in combination with binimetinib (n = 274)
Slovenian: Enkorafenib 450 mg v kombinaciji z binimetinibom (n = 274)
English: Since encorafenib is moderately bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with encorafenib.
Slovenian: Enkorafenib je zmerno vezan na proteine v plazmi, zato hemodializa verjetno ne bo učinkovita pri zdravljenju prevelikega odmerjanja enkorafeniba.
English: Encorafenib is an inhibitor of UGT1A1.
Slovenian: Enkorafenib je inhibitor UGT1A1.
English: BRAF mutation testing
Slovenian: Test mutacij gena BRAF
English: Each pack contains either 28 or 112 hard capsules.
Slovenian: Eno pakiranje vsebuje 28 ali 112 trdih kapsul.
English: Encorafenib is both an inhibitor and inducer of CYP3A4.
Slovenian: Enkorafenib je obenem inhibitor in induktor encima CYP3A4.
English: No formal clinical study has been conducted to evaluate the effect of renal impairment on the pharmacokinetics of encorafenib.
Slovenian: Za ocenjevanje vpliva farmakokinetike enkorafeniba na okvaro ledvic ni bila izvedena nobena uradna klinična študija.
English: What you need to know before you take Braftovi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Braftovi
English: If you continue Braftovi on its own while the other medicine (binimetinib) is temporarily stopped based on your doctor's decision, you may get some of the side effects given in the lists above, although the frequency may change (increase or decrease).
Slovenian: Če zdravilo Braftovi jemljete samostojno, medtem ko je vnos drugih zdravil (binimetiniba) začasno prekinjen, ker se je tako odločil zdravnik, se lahko pri vas pojavijo nekateri stranski učinki, navedeni zgoraj, pri čemer se njihova pogostnost lahko spremeni (poveča ali zmanjša).
English: Skin hyperpigmentation*
Slovenian: Hiperpigmentacija kože*
English: Do not take Braftovi if you are allergic to encorafenib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na enkorafenib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Additionally, no differences in exposure have been observed clinically when binimetinib is co-administered with encorafenib.
Slovenian: Poleg tega niso bile klinično opažene razlike v izpostavljenosti, ko je binimetinib apliciran skupaj z enkorafenibom.