FrancophonIA/ELRC3.0 huggingface dataset:
English: PPES led to discontinuation in 4.1% (9/217) of patients and to dose interruption or dose modification in 23.0% (50/217) of patients.
Slovenian: Zaradi PPES se je pri 4,1 % (9/217) bolnikov prenehalo zdravljenje, pri 23,0 % (50/217) bolnikov pa se je odmerjanje prekinilo ali se je odmerek spremenil.
English: Encorafenib should not be used in patients with wild type BRAF malignant melanoma.
Slovenian: Enkorafeniba ne uporabljajte pri bolnikih z malignim melanomom z nemutiranim genom BRAF (divji tip).
English: CYP3A4 inhibitors
Slovenian: Inhibitorji encima CYP3A4
English: Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017)
Slovenian: Preglednica 6: Študija CMEK162B2301, 1. del: Vmesni rezultati celokupnega preživetja (končni datum 7. november 2017)
English: Liver laboratory abnormalities including AST and ALT elevations have been observed with encorafenib (see section 4.8).
Slovenian: Ob jemanju enkorafeniba so bili opaženi nenormalni laboratorijski izvidi delovanja jeter, vključno s povišanjem AST in ALT (glejte poglavje 4.8).
English: Concomitant agents that are substrates of UGT1A1 (e.g. raltegravir, atorvastatin, dolutegravir) may have increased exposure and should be therefore administered with caution.
Slovenian: (npr. raltegravir, atorvastatin, dolutegravir) lahko povzročijo povečano izpostavljenost in jih je zato treba uporabljati previdno.
English: Recommended dose modifications for encorafenib (when used in combination with binimetinib)
Slovenian: Priporočene spremembe odmerka enkorafeniba (v kombinaciji z binimetinibom)
English: In the pooled encorafenib 300 population, photosensitivity was reported in 4.1% (9/217) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja z enkorafenibom 300 je bil pojav fotosenzitivnosti opažen pri 4,1 % (9/217) bolnikov.
English: • Recurrent Grade 4 (AST or ALT > 20 ULN)
Slovenian: • Ponovni pojav 4. stopnje (AST ali ALT > 20-kratnika ULN)
English: Your doctor will run blood tests to monitor your kidneys before and during treatment.
Slovenian: Zdravnik bo pred zdravljenjem in med njim opravil preiskave krvi in tako spremljal delovanje vaših ledvic.
English: Encorafenib undergoes minimal renal elimination.
Slovenian: Enkorafenib se minimalno izloča prek ledvic.
English: Effect of transporters on encorafenib
Slovenian: Učinek prenašalcev na enkorafenib
English: • Increased transaminases: 13.2% (34/257) overall - Grade 3-4: 5.4% (14/257)
Slovenian: • Povečana raven transaminaze: skupno 13,2 % (34/257) - 3.-4. stopnje: 5,4 % (14/257)
English: This is because it could increase Braftovi side effects.
Slovenian: Ta kombinacija lahko poveča število neželenih učinkov zdravila Braftovi.
English: Hyperkeratosis* Rash*
Slovenian: PPES Hiperkeratoza*
English: Vomiting occurred in 15.2% (39/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
Slovenian: Bruhanje so opazili pri 15,2 % (39/257) bolnikov, pri čemer je pri 0,4 % (1/257) bolnikov prišlo do dogodkov 3. stopnje.
English: Talk to your doctor if you are not sure you can drive.
Slovenian: Če niste prepričani, ali lahko vozite, se posvetujte z zdravnikom.
English: Adverse reactions
Slovenian: Kožne reakcije
English: BRAF V600 Mutant Unresectable or Metastatic Melanoma The safety and efficacy of encorafenib in combination with binimetinib were evaluated in a 2-part Phase III, randomised (1:1:1) active-controlled, open-label, multicentre study in patients with unresectable or metastatic BRAF V600 E or K mutant melanoma (Study CMEK162B2301), as detected using a BRAF assay.
Slovenian: Varnost in učinkovitost enkorafeniba v kombinaciji z binimetinibom sta bili ocenjeni v dvodelni, randomizirani (1 : 1 : 1), z aktivno učinkovino kontrolirani, odprti multicentrični študiji III. faze pri bolnikih z neresektabilnim ali metastatskim melanomom z mutacijo V600 E ali K gena BRAF (študija CMEK162B2301), ki sta bili zaznani z uporabo analiz mutacij gena BRAF.
English: Dry skin*
Slovenian: - temnenje kože,
English: The safety of encorafenib (300 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 257 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the Combo 300 population), based on the Phase III study (CMEK162B2301, Part 2).
Slovenian: Varnost enkorafeniba (peroralno 300 mg enkrat dnevno) v kombinaciji z binimetinibom (peroralno 45 mg dvakrat dnevno) se ovrednotili pri 257 bolnikih z neresektabilnim ali metastatskim melanomom z mutacijo V600 gena BRAF (v nadaljevanju populacija v okviru kombinacije 300) na podlagi študije III. faze (CMEK162B2301, 2. del).
English: Renal dysfunction
Slovenian: Disfunkcija ledvic
English: Encorafenib was phototoxic in an in vitro 3T3 Neutral Red Uptake Test. Encorafenib was not a sensitiser in the in vivo mouse sensitization assay.
Slovenian: Enkorafenib je bil fototoksičen pri in vitro testu 3T3 s privzemom barvila nevtralno rdeče.
English: Number of events (%)
Slovenian: Število dogodkov (%) Mediana, meseci
English: If you take more capsules than you should, contact your doctor, pharmacist or nurse straightaway.
Slovenian: Če ste vzeli več kapsul, kot bi smeli, se nemudoma obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: These melanomas are usually removed by surgery and treatment with Braftovi (and binimetinib) can continue without interruption.
Slovenian: zdravljenje z zdravilom Braftovi (in binimetinibom) pa se lahko neprekinjeno nadaljuje.
English: Braftovi 75 mg hard capsules encorafenib This medicine is subject to additional monitoring.
Slovenian: Braftovi 50 mg trde kapsule Braftovi 75 mg trde kapsule enkorafenib Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: The involvement of several uptake transporter families (OCT1, OATP1B1, OATP1B3 and OATPB1) was investigated in vitro using relevant transporter inhibitors.
Slovenian: OATP1B3 in OATPB1) je bila raziskana in vitro, pri čemer so uporabili ustrezne inhibitorje prenašalcev.
English: • Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520)
Slovenian: • Črnilo za tisk: šelak (E904), črni železov oksid (E172), propilen glikol (E1520)
English: HR (95% CI) (vs Enco 300) p-value (stratified log-rank)
Slovenian: HR (95 % IZ) (proti Enko 300) p-vrednost (stratificirani lograng test)
English: Encorafenib should be permanently discontinued.
Slovenian: Vnašanje enkorafeniba je treba trajno prekiniti.
English: Uncommon (may affect up to 1 in 100 people) - weakness and paralysis of face muscles - inflammation of the pancreas (pancreatitis) causing severe abdominal pain
Slovenian: Občasni lahko se pojavijo pri do 1 od 100 bolnikov) - oslabelost in paraliza mišic obraza,,
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017)
Slovenian: Študija CMEK162B2301, 1. del:: Grafikon po Kaplan-Meierjevem modelu vmesnega celokupnega preživetja (končni datum 7. november 2017)
English: If rash worsens or does not improve within 2 weeks with treatment, encorafenib should be withheld until Grade 0 or 1 and then resumed at the same dose.
Slovenian: Če se izpuščaj poslabša ali po 2 tednih zdravljenja ne izboljša, je treba prenehati z vnosom enkorafeniba, dokler ni dosežena stopnja 0 ali 1. stopnja, ter nato nadaljevati z enakim odmerkom.
English: Encorafenib in combination with binimetinib in patients who have progressed on a BRAF inhibitor There are limited data for the use of the combination of encorafenib with binimetinib in patients who have progressed on a prior BRAF inhibitor given for the treatment of unresectable or metastatic melanoma with BRAF V600 mutation.
Slovenian: Na voljo so omejeni podatki o uporabi enkorafeniba v kombinaciji z binimetinibom pri bolnikih, pri katerih je ob predhodnem jemanju inhibitorja BRAF, ki so ga prejemali za zdravljenje neresektabilnega ali metastatskega melanoma z mutacijo V600 gena BRAF, bolezen napredovala.
English: In the pooled Combo 450 population, anaemia was reported in 19.7% (54/274) of patients; 4.7% (13/274) patients had a Grade 3 or 4.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bila anemija opažena pri 19,7 % (54/274) bolnikov; pri 4,7 % (13/274) bolnikov je prišlo do dogodkov 3. ali 4. stopnje.
English: Uveitis including iritis and iridocyclitis
Slovenian: Vnetje uvee, vključno z vnetjem šarenice in iridociklitisom
English: New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur when encorafenib is administered (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z inhibitorji BRAF, so bili opaženi novi primarni malignomi, dermalni in nedermalni, in se lahko pojavijo pri jemanju enkorafeniba (glejte poglavje 4.8).
English: The encorafenib single agent (300 mg orally once daily) safety profile is based on data from 217 patients with unresectable or metastatic BRAF V600-mutant melanoma (hereafter referred to as the pooled encorafenib 300 population).
Slovenian: Varnostni profil enkorafeniba kot samostojnega zdravila (300 mg enkrat dnevno) temelji na podatkih 217 bolnikov z neresektabilnim ali metastatskim melanomom z mutacijo V600 gena BRAF (v nadaljevanju združena populacija bolnikov, zdravljenih s 300 mg enkorafeniba).
English: Nausea occurred in 41.6% (114/274) with Grade 3 or 4 observed in 2.6% (7/274) of patients.
Slovenian: Do slabosti je prišlo pri 41,6 % (114/274) bolnikov, pri čemer je bila pri 2,6 % (7/274) bolnikov opažena 3. ali 4. stopnja.
English: Encorafenib should be used with caution in patients with severe renal impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s hudo ledvično okvaro je ob uporabi enkorafeniba potrebna previdnost (glejte poglavji 4.4. in 5.2).
English: For information on the posology and recommended dose modifications of binimetinib, see section 4.2 of binimetinib SmPC.
Slovenian: Za informacije o odmerjanju in priporočenih spremembah odmerka binimetiniba glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila binimetinib.
English: It should be considered to permanently discontinue encorafenib.
Slovenian: Treba je razmisliti o trajni prekinitvi vnosa enkorafeniba.
English: Serious side effects Braftovi may cause serious side effects.
Slovenian: Zdravilo Braftovi lahko povzroči resne neželene učinke.
English: New primary malignancies
Slovenian: Novi primarni malignomi
English: It is important to take Braftovi for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.
Slovenian: Pomembno je, da zdravilo Braftovi jemljete tako dolgo, kot vam je predpisal zdravnik.
English: Diarrhoea occurred in 28.4% (73/257) of patients with Grade 3 reported in 1.6% (4/257) of patients.
Slovenian: Drisko so opazili pri 28,4 % (73/257) bolnikov, pri čemer je pri 1,6 % (4/257) bolnikov prišlo do dogodkov 3. stopnje.
English: Or, encorafenib should be permanently discontinued.
Slovenian: Ali pa je treba trajno prekiniti vnos enkorafeniba.
English: HR (95% CI) (vs Vem) p-value (stratified log-rank)
Slovenian: HR (95 % IZ) (proti Vem) p-vrednost (stratificirani lograng test)
English: Liver laboratory abnormality
Slovenian: Nenormalni laboratorijski izvidi delovanja jeter
English: • If improved to Grade 0 or 1 or to baseline levels, then it should be resumed at a reduced dose level.
Slovenian: • Če se stanje izboljša do stopnje 0 ali 1. stopnje oziroma do izhodiščnih vrednosti, potem je treba nadaljevati z zmanjšanim odmerkom.
English: Encorafenib induced CYP1A2, CYP2B6, CYP2C9 and CYP3A4 in human primary hepatocytes.
Slovenian: Enkorafenib je pri človeških primarnih hepatocitih induciral CYP1A2, CYP2B6, CYP2C9 in CYP3A4.
English: Number of events (progressive disease (PD)) (%)
Slovenian: PFS (primarna analiza) Število dogodkov (progresivna bolezen (PD) (%) 98 (51,0)
English: Basal cell carcinoma* Skin papilloma*
Slovenian: Ploščatocelični karcinom kožea Bazalnocelični karcinom*
English: Encorafenib in combination with binimetinib in patients with brain metastases There are limited efficacy data with the combination of encorafenib and binimetinib in patients with a BRAF V600 mutant melanoma which have metastasised to the brain (see section 5.1).
Slovenian: Na voljo so omejeni podatki o učinkovitosti kombinacije enkorafeniba in binimetiniba pri bolnikih z melanomom z mutacijo V600 gena BRAF, ki imajo metastaze v možganih (glejte poglavje 5.1).
English: Each hard capsule contains 50 mg encorafenib.
Slovenian: Ena trda kapsula vsebuje 50 mg enkorafeniba.
English: • Recurrent Grade 4 adverse reactions
Slovenian: • Ponovni pojav neželenih učinkov 4. stopnje
English: In the pooled Combo 450 population, diarrhoea was observed in 38% (104/274) of patients and was Grade 3-4 in 3.3% (9/274) patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bila driska opažena pri 38 % (104/274) bolnikov in je dosegla 3.-4. stopnjo pri 3,3 % (9/274) bolnikov.
English: Each hard capsule contains 75 mg encorafenib.
Slovenian: Ena trda kapsula vsebuje 75 mg enkorafeniba.
English: • If improved to Grade 0 or 1 or to baseline levels, it should be resumed at a reduced dose.
Slovenian: • Če se stanje izboljša do stopnje 0 ali 1. stopnje oziroma do izhodiščnih vrednosti, je treba nadaljevati z zmanjšanim odmerkom.
English: The incidence of Grade 3 or 4 elevation was 0.7% (2/274).
Slovenian: Pojav dviga do 3. ali 4. stopnje je bil opažen pri 0,7 % (2/274) bolnikov.
English: Encorafenib should be maintained.
Slovenian: Vnašanje enkorafeniba je treba nadaljevati.
English: Tell your doctor immediately if you vomit and become dehydrated.
Slovenian: Če bruhate in ste dehidrirani, o tem takoj obvestite zdravnika.
English: Specifically, encorafenib inhibits in vitro and in vivo BRAFV600E, D and K mutant melanoma cell growth.
Slovenian: Natančneje, enkorafenib in vitro in in vivo zavira rast celic melanomov pri mutacijah BRAFV600E, D in K. Enkorafenib ne zavira signalov kinaz RAF/MEK/ERK v celicah z divjim tipom kinaze BRAF.
English: Rash led to discontinuation in 0.5% (1/217) of patients and to dose interruption or dose modification in 7.4% (16/217) of patients.
Slovenian: Zaradi izpuščaja se je pri 0,5 % (1/217) bolnikov prenehalo zdravljenje, pri 7,4 % (16/217) bolnikov pa se je odmerjanje prekinilo ali se je odmerek spremenil.
English: This could affect the ability to father a child. Talk to your doctor if this is a concern for you.
Slovenian: To lahko vpliva na zmožnost spočetja otroka.
English: Benefits and risks should be carefully considered before administering encorafenib to patients with a prior or concurrent cancer associated with RAS mutation.
Slovenian: Pred dajanjem enkorafeniba bolnikom, ki so imeli ali imajo raka, povezanega z mutacijo gena RAS, je treba skrbno razmisliti o koristih in tveganjih.
English: - Bleeding problems: Braftovi may cause serious bleeding problems.
Slovenian: - Krvavitve: Zdravilo Braftovi lahko povzroči resne krvavitve.
English: In the pooled Combo 450 population, fatigue occurred in 43.8% (120/274) of patients including Grade 3 in 2.9% (8/274) of patients.
Slovenian: Pri združeni populaciji bolnikov, zdravljenih v okviru kombinacije 450, so utrujenost opazili pri 43,8 % (120/274) bolnikov, pri čemer je pri 2,9 % (8/274) bolnikov prišlo do dogodkov 3. stopnje.
English: If during treatment patient develops RPED or RVO, see section 4.2 of binimetinib SmPC for guidance.
Slovenian: Če se med terapijo pri bolniku pojavi odstop retinalnega pigmentnega epitelija (RPED) ali okluzija retinalne vene (RVO), za navodila glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila binimetinib.
English: Dose interruption or dose modification occurred in 1.1% (3/274) of patients.
Slovenian: Zdravljenje je bilo zaradi krvavitev treba prekiniti pri 1,1 % (3/274) bolnikov.
English: If Grade 1 or 2 uveitis does not respond to specific (e.g. topical) ocular therapy or for Grade 3 uveitis, encorafenib should be withheld and ophthalmic monitoring should be repeated within 2 weeks.
Slovenian: okularno zdravljenje ali v primeru vnetja uvee 3. stopnje, je treba vnašanje enkorafeniba prekiniti in ponoviti oftalmološki pregled v 2 tednih.
English: Administration of encorafenib should be undertaken with caution at a reduced dose of 300 mg once daily in patients with mild hepatic impairment (Child-Pugh Class A).
Slovenian: Pri bolnikih z blago jetrno okvaro (Child-Pugh razreda A) je potrebna previdnost in enkorafenib vnašati z zmanjšanim odmerkom 300 mg enkrat dnevno.
English: Basal cell carcinoma
Slovenian: Ploščatocelični karcinom kožea
English: Vomiting occurred in 28.1% (77/274) of patients with Grade 3 or 4 reported in 2.2% (6/274) of patients.
Slovenian: Do bruhanja je prišlo pri 28,1 % (77/274) bolnikov, pri čemer je bila pri 2,2 % (6/274) bolnikov opažena 3. ali 4. stopnja.
English: Pancreatic enzyme elevation, mostly asymptomatic, was reported in the pooled Combo 450 population.
Slovenian: Pankreatitis Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bil opažen večinoma asimptomatični dvig encimov trebušne slinavke.
English: In the pooled encorafenib 300 population, facial paresis was observed in 7.4% (16/217) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja z enkorafenibom 300 je bil pojav cuSCC opažen pri 7,4 % (16/217) bolnikov.
English: Also tell your doctor if you have headache, dizziness or weakness.
Slovenian: V primeru glavobola, vrtoglavice ali oslabelosti se prav tako posvetujte z zdravnikom.
English: In the Combo 300 arm in Part 2 of the pivotal study, PPES was observed in 3.9% (10/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
Slovenian: V 2. delu osnovne študije so pri bolnikih, zdravljenih v okviru kombinacije 300, PPES opazili pri 3,9 % (10/257) bolnikov, pri čemer je pri 0,4 % (1/257) bolnikov prišlo do dogodka 3. stopnje.
English: In the pooled encorafenib 300 population, rash was reported in 43.3% (94/217) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja z enkorafenibom 300 je bil pojav izpuščaja opažen pri 43,3 % (94/217) bolnikov.
English: In the pooled Combo 450 population, headache occurred in 21.5% (59/274) of patients, including Grade 3 in 1.5% (4/274) of patients.
Slovenian: Pri združeni populaciji bolnikov, zdravljenih v okviru kombinacije 450, so glavobol opazili pri 21,5 % (59/274) bolnikov, pri čemer je pri 1,5 % (4/274) bolnikov prišlo do dogodkov 3. stopnje.
English: It may cause harm or birth defects to an unborn baby.
Slovenian: Nerojenemu otroku lahko povzroči trajne poškodbe ali razvoj prirojenih motenj.
English: Caution should be exercised if a moderate CYP3A inhibitor is co-administered with encorafenib.
Slovenian: Previdnost je potrebna tudi v primeru, ko se ob sočasnem zdravljenju z enkorafenibom jemlje zmeren inhibitor CYP3A.
English: The hard capsule (capsule) has an orange opaque cap and flesh opaque body, with a stylised “A” printed on the cap and “LGX 50mg” printed on the body.
Slovenian: Trda kapsula (kapsula) ima pokrovček neprozorne oranžne barve in telo neprozorne kožne barve z natisnjeno stilizirano črko »A« na pokrovčku in napisom »LGX 50mg« na telesu.
English: Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules
Slovenian: Braftovi 50 mg trde kapsule Braftovi 75 mg trde kapsule
English: Common cuSCC a New Primary Melanoma*
Slovenian: Novi primarni melanom*
English: In the pooled Combo 450 population, uveitis was reported in 4.4% (12/274) of patients, and was Grade 1 in 0.4% (1/274), Grade 2 in 3.6% (10/274) and Grade 3 in 0.4% (1/274).
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bil pojav vnetja uvee opažen pri 4,4 % (12/274) bolnikov, in sicer 1. stopnje pri 0,4 % (1/274), 2. stopnje pri 3,6 % (10/274)
English: Arthralgia* Myalgiag Pain in extremity Back pain
Slovenian: Bolečine v mišicahg Bolečine v okončinah Bolečine v hrbtu
English: • Recurrent Grade 3 adverse reactions
Slovenian: • Ponovni pojav neželenih učinkov 3. stopnje
English: Renal failure *
Slovenian: Okvara ledvic*
English: • Recurrent Grade 3 (AST or ALT > 5x ULN and blood bilirubin > 2x ULN)
Slovenian: • Ponovni pojav 3. stopnje (AST ali ALT > 5-kratnika ULN in krvni bilitubin > 2kratnika ULN)
English: Talk to your doctor, pharmacist or nurse before taking Braftovi, about all of your medical conditions, particularly if you have any of the following: - heart problems including alteration of the electrical activity of your heart (QT interval prolongation) - bleeding problems or if you are taking medicines that may cause bleeding - eye problems - liver or kidney problems
Slovenian: - težave s srcem, vključno s spremembami v električni aktivnosti srca (podaljšanje intervala QT), - težave s krvavitvami ali če jemljete zdravila, ki lahko povzročijo krvavitve, - težave z očmi,
English: Encorafenib should be permanently discontinued if patient is unable to tolerate 100mg once daily.
Slovenian: Če bolnik ne more prenašati odmerka 100 mg enkrat dnevno, je treba jemanje enkorafeniba trajno prekiniti.
English: Rash led to discontinuation in 0.4% (1/274) patients and to dose interruption or dose modification in 1.1% (3/274) of patients.
Slovenian: Zaradi izpuščaja se je pri 0,4 % (1/274) bolnikov prenehalo zdravljenje, pri 1,1 % (3/274) bolnikov pa se je odmerjanje prekinilo ali se je odmerek spremenil.
English: In the pooled Combo 450 population, facial paresis occurred in 0.7% (2/274) of patients including Grade 3 in 0.4% (1/274) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je prišlo do pareze obraza pri 0,7 % (2/274) bolnikov, vključno s 3. stopnjo pri 0.4% (1/274) bolnikov.
English: Facial paresisc
Slovenian: Pareza obrazac
English: The hard capsule (capsule) has a flesh coloured opaque cap and white opaque body, with a stylised “A” printed on the cap and “LGX 75mg” printed on the body.
Slovenian: Braftovi 75 mg trde kapsule Trda kapsula (kapsula) ima pokrovček neprozorne kožne oranžne barve in telo neprozorne bele barve z natisnjeno stilizirano črko »A« na pokrovčku in napisom »LGX 75mg« na telesu.
English: Effects of encorafenib on other medicinal products CYP substrates
Slovenian: Vplivi enkorafeniba na druga zdravila
English: Braftovi 75 mg: Each hard capsule contains 75 mg encorafenib.
Slovenian: Braftovi 75 mg: Ena trda kapsula vsebuje 75 mg enkorafeniba.
English: Braftovi 75 mg hard capsules Each hard capsule contains 75 mg of encorafenib.
Slovenian: Braftovi 75 mg trde kapsule Ena trda kapsula vsebuje 75 mg enkorafeniba.
English: Arthralgia*
Slovenian: Artralgija*
English: RPED has also been reported in patients treated with encorafenib in combination with binimetinib (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z enkorafenibom v kombinaciji z binimetinibom, so poročali tudi o odstopu retinalnega pigmentnega epitelija (RPED) (glejte poglavje 4.8).
English: Braftovi 50 mg hard capsules Each hard capsule contains 50 mg of encorafenib.
Slovenian: Braftovi 50 mg trde kapsule Ena trda kapsula vsebuje 50 mg enkorafeniba.
English: Uveitis *
Slovenian: Driska*
English: The half maximal inhibitory concentration (IC50) of encorafenib against BRAFV600E, BRAF and CRAF enzymes was determined to be 0.35, 0.47 and 0.30 nM, respectively.
Slovenian: in CRAF je bila ugotovljena v količini 0,35, 0,47 in 0,30 nM za vsakega od navedenih.
English: Ocular events
Slovenian: Očesni dogodki
English: Avoid driving or using machines if you have any problems with your vision, or have any other side effects that can affect your ability to drive or use machines (see section 4), while taking Braftovi.
Slovenian: Če imate težave z vidom ali se pojavljajo drugi neželeni učinki, ki lahko vplivajo na vašo sposobnost upravljanja vozil in strojev
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, anaemia was observed in 9.7% (25/257) of patients with Grade 3-4 reported in 2.7% (7/257) patients.
Slovenian: V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, anemijo opazili pri 9,7 % (25/257) bolnikov, pri čemer je pri 2,7 % (7/257) bolnikov prišlo do dogodkov 3.-4. stopnje.