FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on the severity of symptoms, degree of CK elevation or creatinine elevation, dose reduction, dose interruption or permanent discontinuation of binimetinib may be required (see Table 1 in section 4.2).
Slovenian: Glede na resnost simptomov in stopnjo dviga CK ali kreatinina je lahko potrebno zmanjšati odmerek oziroma začasno ali popolnoma prekiniti vnos binimetiniba (glejte razpredelnico 1
English: In the safety analysis of pooled studies of encorafenib 450 mg once daily in combination with 45 mg binimetinib twice daily (Combo 450), the incidence of new QTc prolongation > 500 ms was 0.7 % (2/268) in the encorafenib 450 mg plus binimetinib group, and 2.5 % (5/203) in the encorafenib single agent group.
Slovenian: Pri varnostni analizi združenih študij za enkratni dnevni odmerek 450 mg enkorafeniba v kombinaciji s 45 mg binimetiniba dvakrat na dan (kombinacija 450) je bila incidenca podaljšanja intervala QTc za > 500 ms 0,7 % (2/268) v skupini z enkorafenibom 450 mg in binimetinibom ter 2,5 % (5/203) v skupini z enkorafenibom kot samostojnim zdravilom.
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 v 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 pri naslednjih neželenih učinkih: anemija, periferna nevropatija, krvavitve, hipertenzija, srbenje (pogosti) in kolitis, zvišana vrednost amilaze in zvišana vrednost lipaze (občasni).
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 poročane pri 27,4 % (75/274) bolnikov in so dosegle 3. stopnjo pri 2,6 % (7/274) bolnikov.
English: • Increased transaminases: 15.7% (43/274) overall - Grade 3-4: 5.5% (15/274)
Slovenian: • Povečana raven transaminaz: skupno 15,7 % (43/274) - 3.-4. stopnje: 5,5 % (15/274)
English: Median DOR for confirmed responses per BIRC was 12.7 months [95% CI: 9.3, 15.1] for Combo 300 and 12.9 months [95 % CI: 8.9, 15.5] for Enco 300.
Slovenian: Mediana vrednosti DOR za potrjene odzive na posamezen pregled BIRC je znašala 12,7 mesecev [95-odstotni IZ: 9,3, 15,1] za kombinacijo 300 in 12,9 mesecev [95-odstotni IZ: 8,9, 15,5] za Enko 300.
English: - The active substance is binimetinib.
Slovenian: - Učinkovina je binimetinib.
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 dajanje odmerkov, pri 4,4 % bolnikov pa se je dajanje odmerkov prekinilo ali se je odmerek spremenil.
English: How to take Mektovi
Slovenian: Kako jemati zdravilo Mektovi
English: Hypertension led to dose interruption or adjustment in 2.9 % of patients.
Slovenian: Zaradi hipertenzije je bil pri 2,9 % bolnikov vnos prekinjen oziroma odmerek zmanjšan.
English: Peripheral oedema i
Slovenian: Periferni edemi
English: Visual disturbances have been reported in patients treated with binimetinib during clinical studies.
Slovenian: Pri bolnikih, zdravljenih z binimetinibom, so v kliničnih študijah poročali o motnjah vida.
English: Patients receiving binimetinib in combination with 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, ki jemljejo binimetinib v kombinaciji z enkorafenibom, je treba, kot je klinično primerno, pred in med zdravljenjem ter po njem pregledati glavo in vrat, opraviti računalniško tomografijo (CT) prsnega koša/trebuha, pregled zadnjika in ginekološki pregled (pri ženskah) ter pregledati celotno krvno sliko.
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: At the recommended dose (n = 274) in patients with unresectable or metastatic melanoma, the most common adverse reactions (> 25 %) occurring in patients treated with binimetinib administered with encorafenib were fatigue, nausea, diarrhoea, vomiting, retinal detachment, abdominal pain, arthralgia, blood CK increased and myalgia.
Slovenian: Ob priporočenem odmerku binimetiniba v kombinaciji z enkorafenibom pri bolnikih (n = 274) z neresektabilnim ali metastatskim melanomom so bili najpogostejši neželeni učinki (> 25 %) utrujenost, slabost, driska, bruhanje, odstop mrežnice, bolečine v trebuhu, boleči sklepi, zvišana vrednost CK v krvi in bolečine v mišicah.
English: Effect of binimetinib on CYP substrates Binimetinib is a weak reversible inhibitor of CYP1A2 and CYP2C9.
Slovenian: Binimetinib je šibek reverzibilen zaviralec CYP1A2 in CYP2C9.
English: Binimetinib 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 binimetiniba je treba prenehati, dokler se stanje ne izboljša do stopnje 0 ali 1. stopnje, ter nato nadaljevati z enakim odmerkom, če je šlo za prvi pojav, oziroma z zmanjšanim odmerkom, če je šlo za ponovni pojav neželenega učinka
English: • Recurrent or intolerable Grade 2 adverse reactions
Slovenian: • Ponavljajoči se ali nevzdržni neželeni učinki 2. stopnje • Prvi pojav neželenih učinkov 3.
English: Binimetinib is not recommended in patients with a history of RVO.
Slovenian: Uporaba binimetiniba ni priporočljiva pri bolnikih, ki so imeli v preteklosti RVO.
English: Mektovi 15 mg film-coated tablets
Slovenian: Mektovi 15 mg filmsko obložene tablete
English: • First occurrence of Grade 3 (AST or ALT > 5x ULN and blood bilirubin > 2x ULN)
Slovenian: • Prvi pojav 3. stopnje (AST ali ALT > 5-kratnika ULN in bilirubin v krvi > 2-kratnika ULN)
English: Talk to your doctor immediately if you have any symptoms of heart problems such as feeling dizzy, tired, lightheaded, if you have shortness of breath, if you feel like your heart is pounding, racing, beating irregularly or if you have swelling in the legs.
Slovenian: Če imate kakršne koli simptome težav s srcem, kot so občutek vrtoglavice, utrujenosti ali omotice, imate kratko sapo, imate občutek razbijanja srca ali pospešenega oz. nepravilnega utripanja srca ali vam otekajo noge, se nemudoma posvetujte z zdravnikom.
English: If encorafenib is permanently discontinued, then binimetinib should be discontinued.
Slovenian: Če je vnos enkorafeniba trajno prekinjen, je treba ukiniti vnos binimetiniba.
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 do fotosenzibilnosti prišlo pri 4,0 % (11/274) bolnikov.
English: Muscle problems: Mektovi can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include:
Slovenian: Težave z mišicami: Zdravilo Mektovi lahko povzroči razkroj mišic (rabdomioliza), zaradi česar lahko pride do okvare ledvic in smrti; znaki in simptomi lahko vključujejo:
English: It is important to take Mektovi for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.
Slovenian: Zdravila ne prenehajte jemati, če vam tega ne naroči zdravnik.
English: Interstitial lung disease (ILD)/pneumonitis • Grade 2
Slovenian: Intersticijska pljučna bolezen (ILD)/pljučnica
English: • Grade 3 (CK > 5 - 10x upper limit of normal (ULN)) asymptomatic
Slovenian: • 3. stopnja (CK > 5-10-kratnika zgornje meje normalne vrednosti
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, the incidences of liver laboratory abnormalities are listed below:
Slovenian: V 2. delu študije CMEK162B2301 so bile pri bolnikih v okviru zdravljenja s kombinacijo 300 pojavnosti nenormalnih laboratorijskih izvidov delovanja jeter naslednje:
English: If rash worsens or does not improve within 2 weeks with treatment, binimetinib should be withheld until improved to Grade 0 or 1 and then resumed at the same dose if first occurrence or resumed at a reduced dose if recurrent Grade2.
Slovenian: Če se izpuščaj poslabša ali po 2 tednih zdravljenja ne izboljša, je treba z vnosom binimetiniba prenehati, dokler se stanje ne izboljša do stopnje 0 ali 1. stopnje, ter nato nadaljevati z enakim odmerkom, če je šlo za prvi pojav, oziroma z zmanjšanim odmerkom, če je šlo za ponovni pojav neželenega učinka
English: Mektovi is for oral use.
Slovenian: Zdravilo Mektovi je namenjeno za peroralno uporabo.
English: 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: Mektovi is not recommended while breast-feeding.
Slovenian: Zdravilo Mektovi se ne priporoča med dojenjem.
English: In part 1, patients in the study were randomised to receive binimetinib 45 mg orally twice daily plus encorafenib 450 mg orally daily (Combo 450, n = 192), encorafenib 300 mg orally daily (hereafter referred to as Enco 300, n = 194), or vemurafenib 960 mg orally twice daily (hereafter referred to as Vem, n = 191).
Slovenian: V 1. delu so bili bolniki v študiji randomizirani na prejemanje 45 mg binimetiniba peroralno dvakrat na dan skupaj z dnevnim odmerkom 450 mg enkorafeniba peroralno (Kombinacija 450, n = 192), z dnevnim odmerkom 300 mg enkorafeniba peroralno (v nadaljevanju Enko 300, n = 194) ali z peroralnim odmerkom 960 mg vemurafeniba dvakrat na dan (v nadaljevanju Vem, n = 191).
English: The median time to definitive 10 % deterioration in the FACT-M score was not reached in the Combo 450 arm and was 22.1 months (95 % CI: 15.2, NE) in the vemurafenib arm with a HR for the difference of 0.46 (95 % CI: 0.29, 0.72).
Slovenian: FACT-M ni bila dosežena pri zdravljenju s kombinacijo 450, pri zdravljenju z vemurafenibom pa je bila 22,1 meseca (95 % IZ: 15,2, NE) z vrednostjo HR razlike 0,46 (95 % IZ: 0,29, 0,72).
English: The extent of drug interactions mediated by UGT1A1 is unlikely to be clinically relevant (see section 5.2); however, as this has not been evaluated in a formal clinical study, UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.
Slovenian: Vendar pa se ta obseg ni ocenil z uradno klinično študijo, zato je pri sočasni uporabi induktorjev UGT1A1 (npr. rifampicina in fenobarbitala) in zaviralcev UGT1A1 (npr. indinavira, atazanavira in sorafeniba) potrebna previdnost.
English: Fertility studies were not conducted with binimetinib.
Slovenian: Z binimetinibom ni bilo izvedenih študij o plodnosti.
English: Effect of transporters on binimetinib
Slovenian: Učinek prenašalcev na binimetinib
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 reaction.
Slovenian: Kakovost življenja (QoL) (končni datum: 19. maj 2016) Za raziskovanje meritev rezultatov, o katerih so bolniki poročali, glede kakovosti življenja in delovanja, glede simptomov melanoma ter neželenih učinkov v povezavi z zdravljenjem, so se uporabili funkcionalna ocena zdravljenja raka - melanom (FACT-M), 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: Hypertension, or worsening of pre-existing hypertension, can occur with the use of binimetinib.
Slovenian: Pri uporabi binimetiniba se lahko pojavi hipertenzija ali poslabšanje obstoječe hipertenzije.
English: Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017)
Slovenian: Preglednica 5: Študija CMEK162B2301, 1. del: Vmesni rezultati celokupnega preživetja (končni datum: 7. november 2017)
English: • medicine typically used to treat high cholesterol such as pravastatin
Slovenian: • zdravilo, ki se običajno uporablja za zdravljenje povišanega holesterola, kot je pravastatin,
English: Median, months (95 % CI)
Slovenian: Mediana, meseci (95 % IZ)
English: HRa (95 % CI) (vs. Vem) Nominal p-value
Slovenian: HRa (95 % IZ) (proti Vem) Nominalna p-vrednost
English: Binimetinib in combination with encorafenib should not be used in patients with wild type BRAF malignant melanoma.
Slovenian: Binimetiniba v kombinaciji z enkorafenibom ne uporabljajte pri bolnikih z malignim melanomom z nemutiranim genom BRAF (divji tip).
English: Table 1: Recommended dose modifications for binimetinib (used in combination with encorafenib) for selected adverse reaction Severity of adverse reactiona
Slovenian: Preglednica 1: Priporočene spremembe odmerka binimetiniba (uporabljenega v kombinaciji z enkorafenibom) pri izbranih neželenih učinkih Resnost neželenega učinkaa
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 bilirubin v krvi > 2-kratnika ULN)
English: Administration of a single 45 mg dose of binimetinib with a high-fat, high-calorie meal decreased the maximum binimetinib concentration (Cmax) by 17 %, while the area under the concentration-time curve (AUC) was unchanged.
Slovenian: Uporaba enkratnega odmerka 45 mg binimetiniba ob obroku, bogatem z maščobami in kalorijami, je zmanjšala najvišjo koncentracijo binimetiniba (Cmax) za 17 %,
English: In the pooled Combo 450 population, LVD was reported in 8.4 % (23/274) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 se je LVD pojavila pri 8,4 % (23/274) bolnikov.
English: Pneumonitis/Interstitial lung disease
Slovenian: Pljučnica/intersticijska pljučna bolezen (ILD)
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 (peroralni odmerek 300 mg enkrat na dan) v kombinaciji z binimetinibom (peroralni odmerek 45 mg dvakrat na dan) se je ocenila 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: • High blood pressure: Mektovi can raise blood pressure.
Slovenian: • Visok krvni tlak: Zaradi zdravila Mektovi se lahko krvni tlak poviša.
English: Binimetinib undergoes minimal renal elimination.
Slovenian: Binimetinib se minimalno izloča preko ledvic.
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 1 od 100 bolnikov) - slabotne obrazne mišice in paraliza obraznih mišic,
English: • Increased transaminases: 13.2% (34/257) overall - Grade 3-4: 5.4% (14/257)
Slovenian: • Povečana raven transaminaz: skupno 13,2 % (34/257) - 3.-4. stopnje: 5,4 % (14/257)
English: VTE led to dose interruptions or dose modifications in 1.1 % (3/274) patients and to additional therapy in 4.7 % (13/274) of patients.
Slovenian: Zaradi VTE je bilo treba prekiniti vnos ali spremeniti odmerek pri 1,1 % (3/274) bolnikov in začeti dodatno zdravljenje pri 4,7 %
English: Heart problems: Mektovi can affect how well your heart works (left ventricular ejection fraction decrease); signs and symptoms can include:
Slovenian: Težave s srcem: Zdravilo Mektovi lahko vpliva na delovanje srca (zmanjšanje iztisnega deleža levega prekata); znaki in simptomi lahko vključujejo:
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: Primarna meritev za oceno učinkovitosti je bila preživetje brez napredovanja (PFS) pri kombinaciji 450 v primerjavi z vemurafenibom.
English: It should be considered to permanently discontinue binimetinib.
Slovenian: Razmisliti je treba o trajni prekinitvi vnosa binimetiniba.
English: Name and address of the manufacturer responsible for batch release
Slovenian: SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (see below, Table 1 and Table 2).
Slovenian: Z namenom obvladovanja neželenih učinkov je lahko potrebno zmanjšanje odmerka oziroma začasna ali popolna prekinitev zdravljenja (glejte spodnji preglednici 1 in 2).
English: Binimetinib in combination with encorafenib in patients who have progressed on a BRAF inhibitor
Slovenian: Binimetinib v kombinaciji z enkorafenibom pri bolnikih z napredovano boleznijo ob jemanju zaviralca BRAF
English: Your doctor will run blood tests to check for muscle problems before and during treatment.
Slovenian: Zdravnik bo pred zdravljenjem in med njim opravil preiskave krvi in tako preveril, ali imate težave z mišicami.
English: The occurrence of LVEF decrease can be managed with treatment interruption, dose reduction or with treatment discontinuation (see section 4.2).
Slovenian: Pojav zmanjšanja LVEF je mogoče zdraviti z začasno prekinitvijo zdravljenja, zmanjšanjem odmerka ali popolno prekinitvijo zdravljenja (glejte poglavje 4.2).
English: Bleeding problems: Mektovi can cause serious bleeding problems.
Slovenian: Težave s krvavitvami: Zdravilo Mektovi lahko povzroči resne krvavitve.
English: • an herbal treatment for depression: St. John's wort
Slovenian: • rastlinsko zdravilo za depresijo: šentjanževka,
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, se je utrujenost pojavila pri 43,8 % (120/274) bolnikov, vključno s 3. stopnjo pri 2,9 % (8/274) bolnikov.
English: • Grade 2 Left ventricular ejection fraction (LVEF) decrease or asymptomatic, absolute decrease in LVEF of greater than 10 % from baseline that is below lower limit of normal (LLN)
Slovenian: Srčni dogodki • Zmanjšani ali asimptomatični iztisni delež levega prekata (LVEF) 2. stopnje, absolutno zmanjšanje LVEF za več kot
English: - itching - dry skin - hair loss or thinning (alopecia) - skin rash of various types - thickening of the outer layers of the skin - joint pain (arthralgia) - muscle pain, weakness or spasm - back pain - pain in the extremities - fever - swelling of the hands or feet (peripheral oedema), localised swelling - fatigue - abnormal blood test results for liver function - abnormal blood test result related to blood creatine kinase, indicating damage to heart and muscle
Slovenian: - bolečine v rokah in nogah, - povišana telesna temperatura, - otekanje rok ali stopal (periferni edem), lokalno otekanje, - utrujenost, - nenormalni rezultati preiskav krvi glede delovanja jeter, - nenormalen rezultat preiskave krvi, povezane s kreatin kinazo v krvi, kar nakazuje na poškodbe srca in mišic.
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017)
Slovenian: Slika 2: Študija CMEK162B2301, 1.del: Grafikon po Kaplan-Meierjevem modelu vmesnega celokupnega preživetja (končni datum: 7. november 2017)
English: After repeat twice-daily dosing concomitantly with encorafenib, steady-state conditions for binimetinib were reached within 15 days with no major accumulation.
Slovenian: Po večkratnem odmerjanju dvakrat na dan hkrati z enkorafenibom se je stacionarno stanje za binimetinib doseglo v
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 0,4 % (1/257) bolnikov je prišlo do dogodkov 3. stopnje.
English: The highest dose of binimetinib evaluated as single agent in clinical studies was 80 mg administered orally twice daily and was associated with ocular (chorioretinopathy) and skin toxicities (dermatitis acneiform).
Slovenian: 80 mg peroralno dvakrat na dan ter je bil povezan z očesno (horioretinopatija) in kožno toksičnostjo (akneiformni dermatitis).
English: The median time to first occurrence of LVD (any grade) was 4.4 months (range 0.03 to 21.3 months) in patients who developed an LVEF below 50 %.
Slovenian: Mediana časa do prvega pojava LVD (katere koli stopnje) je bila 4,4 meseca (v razponu od 0,03 do
English: Fatal gastric ulcer haemorrhage with multiple organ failure as a concurrent cause of death, occurred in one patient.
Slovenian: Pri enem bolniku je krvavitev iz želodčne razjede s sočasno odpovedjo več organov povzročila smrt.
English: LVD led to treatment discontinuation in 0.4% (1/274) of patients and led to dose interruptions or dose reductions in 6.6 % (18/274) of patients.
Slovenian: Zaradi LVD se je zdravljenje prenehalo izvajati pri 0,4 % (1/274) bolnikov, pri 6,6 % (18/274) bolnikov je bil vnos prekinjen oziroma odmerek zmanjšan.
English: Talk to your doctor immediately if you get muscle pain, cramps, stiffness, spasm, dark urine.
Slovenian: V primeru bolečin v mišicah, krčev, togosti, spazmov in temnega urina se posvetujte z zdravnikom.
English: In the pooled Combo 450 population, anaemia was reported in 19.7 % (54/274) of patients; 4.7 % (13/274) of patients had Grade 3 or 4.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bila anemija poročana pri 19,7 % (54/274) bolnikov; pri 4,7 % (13/274) bolnikov je prišlo do dogodkov 3. ali 4. stopnje.
English: Age, body weight
Slovenian: Posebne populacije Starost, telesna masa
English: In the pooled Combo 450 population, RPED was reported in 29.6 % (81/274) of patients.
Slovenian: Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 se je RPED pojavil pri 29,6 % (81/274) bolnikov.
English: • Grade 4 (CK > 10x ULN) asymptomatic
Slovenian: • 4. stopnja (CK > 10-kratnika
English: Adverse reaction
Slovenian: Trajanje odziva
English: Tell your doctor immediately if you get severe headache, feel dizzy or lightheaded or if your blood pressure measured on a home blood pressure device is much higher than usual.
Slovenian: Če imate hud glavobol, občutek vrtoglavice ali omotice oz. če ste si z domačo napravo za merjenje krvnega tlaka izmerili veliko višji krvni tlak kot običajno, se nemudoma posvetujte z zdravnikom.
English: See the package leaflet for further information.
Slovenian: Več informacij je navedenih v navodilu za uporabo.
English: VTE can occur when binimetinib is administered (see section 4.8).
Slovenian: Pri uporabi binimetiniba se lahko pojavi VTE (glejte poglavje 4.8).
English: Therefore, the extent of drug interactions mediated by UGT1A1 is minimal, and unlikely clinically relevant; however, as this has not been evaluated in a formal clinical study, UGT1A1 inducers or inhibitors should be administered with caution.
Slovenian: Zato je obseg interakcij z zdravili, ki vplivajo na UGT1A1, minimalen in verjetno ni klinično pomemben.