FrancophonIA/ELRC3.0 huggingface dataset:
English: Nausea occurred in 41.6 % (114/274) with Grade 3 or 4 observed in 2.6 % (7/274) of patients.
Slovenian: Do navzee je prišlo pri 41,6 % (114/274) bolnikov, pri čemer je bila pri 2,6 % (7/274) bolnikov opažena 3. ali 4. stopnja.
English: Suspicious skin lesions should be managed with dermatological excision and dermatopathologic evaluation.
Slovenian: Vsako sumljivo kožno spremembo je treba izrezati in poslati na histopatološko oceno.
English: New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur when binimetinib is administered in combination with encorafenib (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z zaviralci BRAF, so opazili nove primarne kožne in nekožne malignosti, ki se lahko pojavijo tudi pri jemanju binimetiniba v kombinaciji z enkorafenibom (glejte poglavje 4.8).
English: In cell free system, binimetinib inhibits MEK1 and MEK2 with the half maximal inhibitory concentration (IC50)'s in the 12-46 nM. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation.
Slovenian: V brezceličnem sistemu binimetinib zavira MEK1 in MEK2 pri polovični največji inhibitorni koncentraciji (IC50) 12-46 nM.
English: • If not improved to Grade 2, binimetinib should be permanently discontinued.
Slovenian: • Če se stanje ne izboljša do 2. stopnje, je treba vnašanje binimetiniba trajno prekiniti.
English: In the pooled Combo 450 population, VTE was reported as Grade 1 or 2 in 3.6 % (10/274) of patients and Grade 3 or 4 in 1.1 % (3/274) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bil VTE poročan kot dogodek 1. ali 2. stopnje pri 3,6 % (10/274) bolnikov in 3. ali 4. stopnje pri 1,1 % (3/274) bolnikov.
English: Very common (may affect more than 1 in 10 people) - reduced red blood cell count (anaemia) - problem with the nerves resulting in pain, loss of sensation or tingling in hands and feet - headache - dizziness - bleeding at various sites in the body - problems with your vision (visual impairment) - stomach pain - diarrhoea - being sick (vomiting) - feeling sick (nausea) - constipation
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov) - zmanjšana količina rdečih krvničk (anemija), - težave z živci, ki povzročijo bolečino, izgubo občutljivosti ali mravljinčenje v dlaneh in stopalih,
English: An increased litter incidence of foetal ventricular septal defects and pulmonary trunk alterations was noted at the highest doses.
Slovenian: Pri najvišjih odmerkih so pri leglu zabeležili povečano število defektov v prekatnem pretinu srca pri fetusu in spremembe pljučne arterije.
English: • If the LVEF does not recover within 4 weeks, binimetinib should be permanently discontinued.
Slovenian: • Če se vrednost LVEF ne izboljša v 4 tednih, je treba vnašanje binimetiniba trajno prekiniti.
English: Mektovi can affect your ability to drive or use machines.
Slovenian: Zdravilo Mektovi lahko vpliva na sposobnost upravljanja vozil in strojev.
English: Additionally, the combination of encorafenib and binimetinib prevented the emergence of treatment resistance in BRAF V600E mutant human melanoma xenografts in vivo.
Slovenian: Poleg tega je kombinacija enkorafeniba in binimetiniba pri in vivo preskušanjih ksenotransplantatov s človeškim melanomom z mutacijo BRAF V600E preprečila pojav odpornosti proti zdravljenju.
English: Talk to your doctor immediately if you get blurred vision, loss of vision or other vision changes (such as coloured dots in your vision), halo (seeing blurred outline around objects).
Slovenian: V primeru zamegljenega vida, izgube vida ali drugih sprememb vida (npr. vidite barvaste pikice), kolobarja (vidite zamegljeni obris okrog predmetov) se nemudoma posvetujte z zdravnikom.
English: • Bleeding problems: Mektovi may cause serious bleeding problems.
Slovenian: • Težave s krvavitvami: Zdravilo Mektovi lahko povzroči resne krvavitve.
English: Common (may affect up to 1 in 10 people) - some types of skin tumours such as skin papilloma and basal cell carcinoma - allergic reaction that may include swelling of the face and difficulty breathing - changes in the way things taste - inflammation of the eye (uveitis) - inflammation of the colon (colitis) - redness, chapping or cracking of the skin - inflammation of the fatty layer under the skin, symptoms include tender skin nodules - skin rash with a flat discoloured area or raised bumps like acne (dermatitis acneiform) - redness, skin peeling or blisters on hand and feet (palmar plantar erythrodysesthesia or hand and foot syndrome) - kidney failure - abnormal kidney test results (creatinine elevations) - abnormal blood test results for liver function (blood alkaline phosphatase) - abnormal blood test results for pancreas function (amylase, lipase) - increased skin sensitivity to sunlight
Slovenian: - kožni izpuščaj, z ravno in razbarvano površino ali z izbočenimi deli kot pri aknah (akneiformni dermatitis), - rdeča koža, lupljenje kože ali žulji na rokah in stopalih (sindrom palmarno-plantarne eritrodisestezije ali sindrom roka noga), - odpoved ledvic, - nenormalni rezultati preiskav delovanja ledvic (dvig kreatinina), - nenormalni rezultati preiskav krvi glede delovanja jeter (alkalna fosfataza v krvi), - nenormalni rezultati preiskav krvi glede delovanja trebušne slinavke (amilaza, lipaza),
English: The occurrence of Grade ≥ 3 haemorrhagic events should be managed with dose interruption, reduction or treatment discontinuation (see Table 2 in section 4.2) and as clinically indicated.
Slovenian: Pojav krvavitev 3. stopnje ali višje je treba nadzirati s prekinitvijo vnosa, zmanjšanjem odmerka ali popolnim prenehanjem zdravljenja (glejte preglednico 2 v poglavju 4.2) in kakor je klinično indicirano.
English: For information on the posology and recommended dose modifications of encorafenib, see section 4.2 of encorafenib SmPC.
Slovenian: Za informacije o odmerjanju in priporočenih spremembah odmerka enkorafeniba glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila enkorafenib.
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 1,6 % (4/257) bolnikov je prišlo do dogodkov 3. stopnje.
English: In the pooled Combo 450 population, mostly mild asymptomatic blood CK elevation was reported in 27.0 % (74/274) of patients.
Slovenian: Dvig CK/rabdomioliza Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bil večinoma blag asimptomatični dvig CK poročan pri 27,0 % (74/274) bolnikov.
English: Liver laboratory abnormalities should be managed with dose interruption, reduction or treatment discontinuation (see Table 1 in section 4.2).
Slovenian: Nenormalne laboratorijske izvide delovanja jeter je treba nadzirati s prekinitvijo vnosa, zmanjšanjem odmerka ali popolnim prenehanjem zdravljenja (glejte razpredelnico 1 v poglavju 4.2).
English: Combination with encorafenib
Slovenian: Kombinacija z enkorafenibom
English: • dark urine
Slovenian: • temen urin.
English: Mektovi 15 mg film-coated tablets binimetinib
Slovenian: Mektovi 15 mg filmsko obložene tablete binimetinib
English: Binimetinib should be permanently discontinued.
Slovenian: Vnašanje binimetiniba je treba trajno prekiniti.
English: The occurrence of symptomatic RPED can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Slovenian: Pojav simptomatičnega RPED je mogoče zdraviti z začasno prekinitvijo zdravljenja, zmanjšanjem odmerka ali popolno prekinitvijo zdravljenja (glejte preglednico 1 v poglavju 4.2).
English: • feeling dizzy, tired or lightheaded
Slovenian: • občutek vrtoglavice, utrujenosti ali omotice, • kratko sapo,
English: Table 2: Recommended dose modifications for binimetinib (used in combination with encorafenib) for other adverse reactions
Slovenian: Preglednica 2: Priporočene spremembe odmerka binimetiniba (uporabljenega v kombinaciji z enkorafenibom) pri drugih neželenih učinkih Resnost neželenega učinka
English: The mean (CV %) Cmax,ss was 654 ng/mL (34.7 %) and mean AUCss was 2.35 ug.h/mL (28.0 %) in combination with encorafenib as estimated by population PK modelling.
Slovenian: AUCss pa 2,35 ug.h/ml (28,0 %) v kombinaciji z enkorafenibom, ocenjeno s populacijskim farmakokinetičnim modelom.
English: Benefits and risks should be carefully considered before administering binimetinib in combination with encorafenib to patients with a prior or concurrent cancer associated with RAS mutation.
Slovenian: Razmisliti je treba o trajni prekinitvi vnosa binimetiniba in enkorafeniba pri bolnikih, pri katerih se razvijejo nekožne malignosti, pozitivne na mutacijo RAS. Pred dajanjem binimetiniba v kombinaciji z enkorafenibom bolnikom, ki so imeli ali imajo raka, povezanega z mutacijo RAS, je treba skrbno preučiti razmerje med koristjo in tveganjem.
English: HRa (95 % CI) (vs Vem)
Slovenian: HRa (95 % IZ) (proti Vem)
English: If you take more tablets than you should, contact your doctor, pharmacist or nurse straightaway.
Slovenian: Če ste vzeli večji odmerek zdravila Mektovi, kot bi smeli Če ste vzeli več tablet, kot bi smeli, se nemudoma obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: A two-fold increase in total binimetinib exposure (AUC) was observed in patients with moderate (Child-Pugh Class B) and severe (Child-Pugh Class C) hepatic impairment (see section 4.2).
Slovenian: Pugh razreda B) in hudo (Child-Pugh razreda C) okvaro jeter je bilo opaženo dvakratno povečanje skupne izpostavljenosti binimetinibu (AUC) (glejte poglavje 4.2).
English: Panniculitis*
Slovenian: Panikulitis*
English: Table 5:
Slovenian: Prilogi V.
English: BRAF V600 mutant unresectable or metastatic melanoma The safety and efficacy of binimetinib in combination with encorafenib were evaluated in a 2-part Phase III, randomised (1:1:1) active-controlled, open-label, multicenter study in patients with unresectable or metastatic BRAF V600 E or K mutant melanoma (Study CMEK162B2301), as detected using a BRAF assay.
Slovenian: randomizirani (1 : 1 : 1), z aktivno učinkovino nadzorovani, odprti multicentrični študiji III. faze na bolnikih z neresektabilnim ali metastatskim melanomom z mutacijo V600 E ali K gena BRAF (študija CMEK162B2301), zaznano z uporabo analize BRAF.
English: Immune system disorders Hypersensitivityb
Slovenian: Bolezni imunskega sistema Preobčutljivostb
English: • If not improved, binimetinib should be permanently discontinued.
Slovenian: • če se stanje ne izboljša, je treba vnašanje binimetiniba trajno prekiniti.
English: Liver laboratory abnormalities
Slovenian: Nenormalni laboratorijski izvidi delovanja jeter
English: HRa (95 % CI) (vs Enco 300) p value (stratified log-rank)b
Slovenian: HRa (95 % IZ) (proti Enko 300) p-vrednost (stratificirani log-rang test)b
English: Severity of adverse reaction
Slovenian: Resnost neželenega učinkaa
English: In the pooled Combo 450 population, diarrhoea was observed in 38 % (104/274) of patients and was Grade 3 or 4 in 3.3 % (9/274) of 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. ali 4. stopnjo pri 3,3 % (9/274) bolnikov.
English: • Tablet film-coat: polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E533b), iron oxide yellow (E172) and iron oxide black (E172).
Slovenian: • Filmska obloga tablete: polivinil alkohol (E1203), makrogol 3350 (E1521), titanov dioksid
English: As encorafenib is not recommended in patients with moderate (Child Pugh B) or severe hepatic impairment (Child-Pugh C), administration of binimetinib is not recommended in these patients.
Slovenian: Vnašanje enkorafeniba se ne priporoča pri bolnikih z zmerno (Child-Pugh B) ali hudo jetrno okvaro (Child-Pugh C), zato se dajanje binimetiniba ne priporoča pri teh bolnikih (glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila enkorafenib).
English: • liver problems
Slovenian: • težave z jetri.
English: • If improved to Grade 2, binimetinib should be resumed at a lower dose.
Slovenian: • Če se stanje izboljša do 2. stopnje, je treba nadaljevati z vnosom manjšega odmerka binimetiniba.
English: Rhabdomyolysis was reported in 0.4 % (1/274) of patients treated with encorafenib in combination with binimetinib.
Slovenian: Pri bolnikih, zdravljenih z enkorafenibom v kombinaciji z binimetinibom, so poročali o rabdomiolizi pri 0,4 % (1/274) bolnikov.
English: LVD defined as symptomatic or asymptomatic decreases in ejection fraction can occur when binimetinib is administered.
Slovenian: Disfunkcija levega prekata (LVD - Left ventricular dysfunction) Pri uporabi binimetiniba se lahko pojavi LVD, opredeljena kot simptomatično ali asimptomatično zmanjšanje iztisnega deleža.
English: • blood clots
Slovenian: • krvne strdke,
English: An interim OS analysis of study CMEK162B2301 Part 1, (cut-off date 07 November 2017) demonstrated a statistically significant improvement in OS for Combo 450 compared with vemurafenib (see Table 5 and Figure 2).
Slovenian: 7. november 2017) je pokazala statistično pomembno izboljšanje vrednosti OS pri kombinaciji 450 v primerjavi z vemurafenibom (glejte preglednico 5 in sliko 2).
English: The median time to onset of the first event was 2.7 months (range: 0.5 to 17.5 months).
Slovenian: Mediana časa do prvega pojava je bila 2,7 meseca (v razponu:
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, se je glavobol pojavil pri 21,5 % (59/274) bolnikov, pri 1,5 % (4/274) bolnikov je prišlo do dogodkov 3. stopnje.
English: Transaminase increased*
Slovenian: Zvišana vrednost transminaze*
English: How to store Mektovi
Slovenian: Shranjevanje zdravila Mektovi
English: Mektovi contains lactose
Slovenian: Zdravilo Mektovi vsebuje laktozo
English: • Blood clots: Mektovi can cause blood clots in your arms or legs, and if a clot travels to your lungs it could lead to death.
Slovenian: • Krvni strdki: Zdravilo Mektovi lahko v rokah in nogah povzroči nastanek krvnih strdkov.
English: • If not resolved within 4 weeks, binimetinib should be permanently discontinued.
Slovenian: • če se stanje ne izboljša v 4 tednih, je treba vnašanje binimetiniba trajno prekiniti.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES)
Slovenian: Sindrom roka-noga (PPES)
English: Inducers of CYP1A2 enzymes (such as carbamazepine and rifampicin) and inducers of Pgp transport (such as Saint John's wort or phenytoin) may decrease binimetinib exposure, which could result in a decrease of efficacy.
Slovenian: Induktorji encimov CYP1A2 (npr. karbamazepin in rifampicin) in induktorji prenosa s Pgp (npr.
English: Liver laboratory abnormalities including AST and ALT elevations can occur with binimetinib (see section 4.8).
Slovenian: Ob jemanju binimetiniba se lahko pojavijo nenormalni laboratorijski izvidi delovanja jeter, vključno s povišanjem vrednosti AST in ALT (glejte poglavje 4.8).
English: Your doctor or nurse will check your blood pressure before and during treatment with Mektovi.
Slovenian: Pred zdravljenjem z zdravilom Mektovi in med njim vam bosta zdravnik ali medicinska sestra preverila krvni tlak.
English: • Grade 4 PE
Slovenian: • PE 4. stopnje
English: • If improved to Grade 0 or 1, binimetinib should be resumed at same dose.
Slovenian: • Če se stanje izboljša do stopnje 0 ali 1. stopnje, je treba nadaljevati z vnosom enakega odmerka binimetiniba.
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Sistemska razvrstitev organov
English: Talk to your doctor if you are not sure you can drive.
Slovenian: Če niste prepričani, ali lahko upravljate vozila, se posvetujte z zdravnikom.
English: If no improvement within 2 weeks, binimetinib should be withheld until improved to Grade 0 or 1 or to baseline levels, and then resumed at the same dose.
Slovenian: Če se v 2 tednih stanje ne izboljša, je treba vnašanje binimetiniba prekiniti, dokler se stanje ne izboljša do stopnje 0 ali 1. stopnje,
English: • feeling like your heart is pounding, racing or beating irregularly
Slovenian: • občutek razbijanja srca ali pospešenega oz. nepravilnega utripanja srca,
English: Blood alkaline phosphatase increased Common Amylase increased
Slovenian: Zvišana vrednost alkalne fosfataze v krvi
English: Mektovi contains lactose.
Slovenian: Zdravilo Mektovi vsebuje laktozo.
English: Uveitis*
Slovenian: Srbenje*
English: Cutaneous squamous cell carcinomaa
Slovenian: Ploščatocelični karcinom kožea
English: If during treatment patient develops uveitis, see section 4.2 of encorafenib SmPC for guidance.
Slovenian: Če se med terapijo pri bolniku pojavi vnetje uvee, za navodila glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila enkorafenib.
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 2,7 % (7/257) bolnikov je prišlo do dogodkov 3.-4. stopnje.
English: Pneumonitis/ILD can occur with binimetinib.
Slovenian: Pri uporabi binimetiniba se lahko pojavi pljučnica/ILD.
English: Asymptomatic CK elevations are seen in patients treated with binimetinib (see section 4.8), and, rhabdomyolysis was uncommonly reported.
Slovenian: Pri bolnikih, zdravljenih z binimetinibom (glejte poglavje 4.8), so opazili asimptomatična povišanja kreatin fosfokinaze (CK).
English: Left ventricular dysfunction
Slovenian: Disfunkcija levega prekatad
English: Effects of other medicinal products on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Slovenian: Binimetinib se primarno presnavlja z glukuronidacijo preko UGT1A1.
English: Haemorrhagic events were observed in 17.9 % (49/274) of patients in the pooled Combo 450 population.
Slovenian: 17,9 % (49/274) bolnikov.
English: Vomiting*
Slovenian: Bruhanje*
English: Uveitis including iridocyclitis and iritis have been reported in patients treated with binimetinib in combination with encorafenib (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z binimetinibom v kombinaciji z enkorafenibom, so poročali o vnetju uvee, vključno z iridociklitisom in vnetjem šarenice (glejte poglavje 4.8).
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, headache was reported in 12.1% (31/257) of patients and was Grade 3 in 0.4% (1/257) of patients.
Slovenian: V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, glavobol poročali pri 12,1 % (31/257) bolnikov, pri 0,4 % (1/257) bolnikov je bil 3. stopnje.
English: Renal failure*
Slovenian: Odpoved ledvic*
English: Rash led to treatment discontinuation in 0.4 % (1/274) of 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 dajanje odmerkov prekinilo ali se je odmerek spremenil.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, fatigue was observed in 33.5% (86/257) of patients with 1.6% (4/257) Grade 3-4 events.
Slovenian: V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, utrujenost opazili pri 33,5 % (86/257) bolnikov, z dogodki 3.-4. stopnje pri 1,6 % (4/257) bolnikov.
English: Cutaneous reactions • Grade2
Slovenian: Kožne reakcije • 2. stopnja
English: Dose modification was reported in 0.7 % (2/274) of patients.
Slovenian: 0,7 % (2/274) bolnikov so poročali o spremembi odmerka.
English: The safety of binimetinib (45 mg orally twice daily) in combination with encorafenib (450 mg orally once daily) (hereafter referred to as Combo 450) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma, based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1) (hereafter referred to as the pooled Combo 450 population).
Slovenian: Varnost binimetiniba (peroralno 45 mg dvakrat dnevno) v kombinaciji z enkorafenibom (peroralno 450 mg enkrat dnevno) (v nadaljevanju kombinacija 450) so ovrednotili pri 274 bolnikih z neresektabilnim ali metastatskim melanomom z mutacijo V600 gena BRAF na podlagi dveh študij II.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, nausea was observed in 27.2% (70/257) of patients and was Grade 3 in 1.6% (4/257) of patients.
Slovenian: V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, slabost opazili pri 27,2 % (70/257) bolnikov, pri 1,6 % (4/257) bolnikov je bila 3. stopnje.
English: • eye problems including glaucoma or increased pressure in your eyes
Slovenian: • težave s krvavitvami ali če jemljete zdravila, ki lahko povzročijo krvavitve, • težave z očmi, vključno z glavkomom ali povišanim tlakom v očeh,
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, RPED was observed in 12.5% (32/257) of patients with 0.4% (1/257) Grade 4 event.
Slovenian: V 2. delu študije CMEK162B2301 so RPED pri bolnikih, zdravljenih v okviru kombinacije 300, opazili pri 12,5 % (32/257) bolnikov, pri 0,4 % (1/257) bolnikov je bila 4. stopnje.
English: Cutaneous malignancies
Slovenian: Kožne malignosti
English: Binimetinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity.
Slovenian: Binimetinib zavira aktivacijo proteinov MEK, ki jo sproži
English: • If resolved within 4 weeks, binimetinib should be resumed at a reduced dose, or
Slovenian: • Če se v 4 tednih stanje izboljša, je treba nadaljevati z zmanjšanim odmerkom binimetiniba, ali • vnašanje binimetiniba je treba trajno prekiniti.
English: Facial paresis was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Slovenian: O parezi obraza so poročali, ko se je binimetinib uporabljal v kombinaciji z enkorafenibom (glejte poglavje 4.8 Povzetka glavnih značilnosti zdravila enkorafenib).
English: HRa (95 % CI) (vs Vem) p-value (stratified log-rank) HRa (95 % CI) (vs. Enco 300) p-value (stratified log-rank)
Slovenian: HRa (95-odstotni IZ) (proti Enko 300) p-vrednost (stratificirani log-rang test)
English: Binimetinib should be withheld.
Slovenian: Vnašanje binimetiniba je treba prekiniti.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, haemorrhagic events were observed in 6.6% (17/257) of patients and were Grade 3-4 in 1.6% (4/257) of patients.
Slovenian: V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, krvavitve opazili pri 6,6 % (17/257) bolnikov, ki so bile pri 1,6 % (4/257) bolnikov 3-4. stopnje.
English: Blood creatinine elevation and renal failure occurred when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Slovenian: Pri jemanju binimetiniba v kombinaciji z enkorafenibom sta se pojavila dvig kreatinina v krvi in odpoved ledvic (glejte poglavje 4.8 Povzetka glavnih značilnosti zdravila enkorafenib).
English: In patients treated with Combo 450, dermatitis acneiform occurred in 4.4 % (12/274) of patients, was Grade 1 and 2 and no event led to treatment discontinuation.
Slovenian: Pri bolnikih, zdravljenih s kombinacijo 450, se je akneiformni dermatitis pojavil pri 4,4 % (12/274) bolnikov.
English: Patients at risk COMBO 450
Slovenian: ki so se zdravili s kombinacijo 450.
English: Dizziness*
Slovenian: Vrtoglavica*
English: • If improved to Grade 0 or 1, binimetinib should be resumed at reduced dose, or
Slovenian: • Če se stanje izboljša do stopnje 0 ali 1. stopnje, je treba nadaljevati z zmanjšanim odmerkom binimetiniba, ali
English: • If improved to Grade 0 or 1 or baseline level, binimetinib should be resumed at reduced dose, or
Slovenian: • Če se stanje izboljša do stopnje 0 ali 1. stopnje oziroma do izhodiščne vrednosti, je treba nadaljevati z zmanjšanim odmerkom binimetiniba, ali
English: Pruritus*
Slovenian: Driska*
English: Binimetinib should be maintained.
Slovenian: Vnašanje binimetiniba je treba nadaljevati.
English: Abdominal pain*
Slovenian: Bolečine v trebuhu*