FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: III, magħmul b'mod każwali (1:1:1), ikkontrollat b'mod attiv, open-label, multiċentriku f'pazjenti b'melanoma li ma tistax titneħħa jew metastatika mutanti BRAF V600 E jew K (Studju CMEK162B2301), kif identifikat permezz ta' assaġġ BRAF.
English: Mektovi targets another protein called “MEK” that stimulates cancer cell growth.
Maltese: Mektovi jimmira proteina oħra msejħa “MEK” li tistimula t-tkabbir taċ-ċelluli tal-kanċer.
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.
Maltese: Fil-popolazzjoni Combo 450 miġbura, ġiet osservata dijarea fi 38 % (104/274) tal-pazjenti u kienet ta' Grad 3 jew 4 fi 3.3 % (9/274) tal-pazjenti.
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.
Maltese: Indutturi ta' enzimi CYP1A2 (bħal carbamazepine u rifampicin) u indutturi ta' trasport Pgp (bħal St.
English: Peripheral oedema i
Maltese: Edema periferalii
English: Vomiting occurred in 28.1 % (77/274) of patients with Grade 3 or 4 reported in 2.2 % (6/274) of patients.
Maltese: Ir-rimettar seħħ fi 28.1 % (77/274) tal-pazjenti bi Grad 3 jew 4 fi 2.2 % (6/274) tal-pazjenti.
English: The mean LVEF value dropped by 5.9 % in the pooled Combo 450 population, from a mean of 63.9 % at baseline to 58.1 %.
Maltese: Il-valur medju tal-LVEF naqas b'5.9 % filpopolazzjoni Combo 450 miġbura minn medja ta' 63.9 % fil-linja bażi għal 58.1 %.
English: Pneumonitis/Interstitial lung disease
Maltese: Pulmonite/Marda interstizjali tal-pulmun
English: (see section 4.2 of encorafenib SmPC).
Maltese: (ara sezzjoni 4.2).
English: Rash *
Maltese: Raxx*
English: In patients treated with Combo 450 (n = 274), 194 patients (70.8 %) were < 65 years old, 65 patients (23.7 %) were 65 -74 years old and 15 patients (5.5 %) were aged > 75.
Maltese: 8 %) kellhom < 65 sena, 65 pazjent (23.7 %) kellhom 65 -74 sena u 15-il pazjent (5.5 %) kellhom > 75.
English: Yellow to dark yellow, unscored biconvex, ovaloid film-coated tablets approximately 12 mm in length and 5 mm in width, with the “A” logo debossed on one side of the tablet and “15” on the other side.
Maltese: Pilloli miksija b'rita ovali bikonvessi mhux maqsumin ta' kulur isfar għal isfar skur, ta' tul ta' madwar 12 mm u wisa' ta' 5 mm, bil-logo “A” imnaqqax fuq naħa waħda tal-pillola u “15” fuq in-naħa l-oħra.
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.
Maltese: L-okkorrenza ta' avvenimenti emorraġiċi ta' Grad ≥ 3 għandhom jiġu mmaniġġjati b'interruzzjoni fid-doża, tnaqqis fid-doża jew bi twaqqif tal-kura (ara Tabella 2 f'sezzjoni 4.2) u kif indikat klinikament.
English: Cutaneous malignancies such as cutaneous squamous cell carcinoma (cuSCC) including kerathoacanthoma has been observed in patients treated with binimetinib when used in combination with encorafenib.
Maltese: Ġew osservati malinni tal-ġilda bħal karċinoma taċ-ċelluli skwamużi tal-ġilda (cuSCC, cutaneous squamous cell carcinoma) inkluż keratoakantoma f'pazjenti kkurati b'binimetinib meta jintuża flimkien ma' encorafenib.
English: Table 3: Adverse reactions occurring in patients receiving binimetinib in combination with encorafenib at the recommended dose (n = 274) System Organ Class
Maltese: encorafenib bid-doża rakkomandata (n = 274) Sistema tal-Klassifika talOrgani
English: Vomiting occurred in 15.2% (39/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
Maltese: Rimettar seħħ fi 15.2% (39/257) tal-pazjenti bi Grad 3 irrappurtat f'0.4% (1/257) tal-pazjenti.
English: HRa (95 % CI) (vs. Vem) Nominal p-value
Maltese: HRa (95 % CI) (vs. Vem) valur p nominali HRa (95 % CI) (vs.
English: Similar results were observed per Investigator assessment.
Maltese: Ġew osservati riżultati simili skont l-evalwazzjoni tal-Investigatur.
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.
Maltese: Fl-Istudju CMEK162B2301-Parti 2, fil-fergħa Combo 300 arm, anemija ġiet osservata f'9.7% (25/257) tal-pazjenti bi Grad 3-4 irrappurtat fi 2.7% (7/257) tal-pazjenti.
English: Number of Events (%) Median, months (95 % CI)
Maltese: Numru ta' avvenimenti (marda progressiva) (%) Medjana, xhur (95% CI)
English: 84 film-coated tablets 168 film-coated tablets
Maltese: 84 pillola miksijin b'rita 168 pillola miksijin b'rita
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattożju, b'defiċjenza totali għal-lattażju jew b'malassorbiment ta' glukożju-galattożju m'għandhomx jieħdu dan il-prodott mediċinali.
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.
Maltese: Fil-popolazzjoni Combo 450 miġbura, VTE ġie rrappurtat bħala ta' Grad 1 jew 2 f'3.6 % (10/274) tal-pazjenti u Grad 3 jew 4 f'1.1 % (3/274) tal pazjenti.
English: • a particular change (mutation) in a gene responsible for producing a protein called BRAF, and
Maltese: • bidla partikolari (mutazzjoni) fil-ġene responsabbli għal produzzjoni ta' proteina msejħa
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).
Maltese: Ġiet osservata żieda ta' darbtejn fl-esponiment totali għal binimetinib (AUC) f'pazjenti b'indeboliment tal-fwied moderat (Child-Pugh Klassi B) u sever
English: The proportion of patients experiencing adverse events and serious adverse events were similar in patients aged <65 years and those aged > 65 years.
Maltese: Il proporzjon tal-pazjenti li esperjenzaw reazzjonijiet avversi u avvenimenti avversi serji kien simili fil pazjenti li kellhom < 65 sena u dawk li kellhom >65 sena.
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.
Maltese: Ir-raxx wassal għat-twaqqif tal-kura f'0.4 % (1/274) tal-pazjenti u għal interruzzjoni fid-doża jew modifikazzjoni fid-doża f'1.1 % (3/274) tal-pazjenti.
English: Encorafenib + binimetinib n = 192 (Combo 450)
Maltese: Riżultati interim ta' sopravivenza globali (data tal-cut-off 7 ta' Novembru 2017) Encorafenib + binimetinib n = 192 (Combo 450)
English: Grade 3 events occurred in 1.1 % (3/274) of patients.
Maltese: Avvenimenti ta' Grad 3 seħħew f'1.1 % (3/274) tal-pazjenti.
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.
Maltese: Għalhekk, illimitu ta' interazzjonijiet mediċinali minn UGT1A1 huwa minimu, u aktarx mhuwiex klinikament rilevanti; madankollu, peress li dan ma ġiex evalwat fi studju kliniku formali, indutturi jew inibituri ta' UGT1A1 għandhom jingħataw b'kawtela.
English: New onset elevated blood pressure or worsening of pre-existing hypertension were reported in 11.7 % (32/274) of patients treated with the Combo 450.
Maltese: Bidu ġdid ta' żieda fil-pressjoni tad-demm jew aggravar ta' ipertensjoni preeżistenti ġew irrappurtati f'1.7 % (32/274) tal-pazjenti kkurati bil-Combo 450.
English: If encorafenib is temporarily interrupted (see section 4.2 of encorafenib SmPC), binimetinib should be interrupted.
Maltese: Jekk encorafenib jiġi interrott temporanjament (ara sezzjoni 4.2 tal-SmPC ta' encorafenib),
English: In a gastric irritation study in rats, an increased incidence of superficial mucosal lesions and of hemorrhagic ulcers were observed.
Maltese: ġiet osservata inċidenza miżjuda ta' leżjonijiet mukożali superfiċjali u ta' ulċeri emorraġiċi.
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)
Maltese: • Tnaqqis fil-frazzjoni tal-ħruġ ventrikolari tax-xellug (LVEF) ta' Grad 2 jew tnaqqis asintomatiku u assolut fil-LVEF ta' aktar minn 10 % mil-linja bażi li jinsab taħt il-limitu aktar baxx tan-normal (LLN, lower limit of normal)
English: How to take Mektovi
Maltese: Mediċini oħra u Mektovi
English: Haemorrhagic events led to discontinuation of treatment in 1.1 % (3/274) of patients.
Maltese: L-avvenimenti emorraġiċi wasslu għat-twaqqif tal-kura f'1.1 % (3/274) talpazjenti.
English: The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (see below, Table 1 and Table 2).
Maltese: L-immaniġġjar tar-reazzjonijiet avversi jista' jeħtieġ tnaqqis fid-doża, interruzzjoni temporanja jew waqfien tal-kura (ara hawn taħt, Tabella 1 u Tabella 2).
English: In rabbits, mortality, maternal physical signs of toxicity, lower gestational body weight and abortion were noted.
Maltese: Fil-fniek, ġew innutati mortalità, sinjali fiżiċi materni ta' effett tossiku, piż tal-ġisem ġestazzjonali aktar baxx u abort.
English: • liver problems
Maltese: • Problemi ta' fsada:
English: In clinical study sub-analysis, however, there was no apparent relationship observed between binimetinib exposure and UGT1A1 mutation status.
Maltese: Madankollu, f'sottoanaliżi ta' studju kliniku, ma kien hemm l-ebda relazzjoni apparenti osservata bejn l-esponiment għal binimetinib u l-istatus ta' mutazzjoni UGT1A1.
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, the apparent volume of distribution (Vz/F) of binimetinib is 374 L.
Maltese: Wara doża orali waħda ta' 45 mg [14C] binimetinib f'individwi b'saħħithom, il-volum apparenti ta' distribuzzjoni (Vz/F) ta' binimetinib huwa 374 L. Bijotrasformazzjoni
English: In addition, simulations to investigate the effect of 400 mg atazanavir (UGT1A1 inhibitor) on the exposure of 45 mg binimetinib predicted similar binimetinib Cmax in the presence or absence of atazanavir.
Maltese: Barra minn hekk, simulazzjonijiet sabiex jinvestigaw l-effett ta' 400 mg atazanavir (inibitur ta' UGT1A1) fuq l-esponiment ta' 45 mg binimetinib bassru Cmax ta' binimetinib simili fil-preżenza jew fin-nuqqas ta' atazanavir.
English: In repeat-dose toxicity studies, no concern in terms of fertility was raised from pathological examination of reproductive organs in rats and monkeys.
Maltese: Fi studji ta' effett tossiku minn dożi ripetuti, ma tqajjem l ebda tħassib f'termini ta' fertilità mill-eżami patoloġiku tal-organi riproduttivi fil-firien u fix-xadini.
English: Venous thromboembolismf
Maltese: Uġigħ fl-estremitajiet
English: CI = confidence interval; CR = complete response; DCR = disease control rate (CR+PR+SD+NonCR/Non-PD; Non-CR/Non-PD applies only to patients without a target lesion who did not achieve CR or have PD); HR = hazard ratio; NE = not estimable; PFS = progression-free survival; PR = partial response; SD = stable disease.
Maltese: CI = intervall ta' kunfidenza; CR = rispons komplet; DCR = rata tal-kontroll tal-marda (CR+PR+SD+Mhux
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.
Maltese: Fl-Istudju CMEK162B2301-Parti 2, fil-fergħa Combo 300, għeja ġiet osservata fi 33.5% (86/257) tal pazjenti b'1.6% (4/257) avvenimenti ta' Grad 3-4.
English: Table 1: Recommended dose modifications for binimetinib (used in combination with encorafenib) for selected adverse reaction Severity of adverse reactiona
Maltese: Tabella 1: Modifikazzjonijiet fid-doża rrakkomandati għal binimetinib (użat flimkien ma' encorafenib) għar-reazzjoni avversa magħżula
English: Part 1 of study CMEK162B2301 demonstrated a statistically significant improvement in PFS in the patients treated with Combo 450 compared with patients treated with vemurafenib.
Maltese: Parti 1 tal-istudju CMEK162B2301 wera titjib statistikament sinifikanti fil-PFS fil-pazjenti kkurati b'Combo 450 meta mqabbel mal-pazjenti kkurati b'vemurafenib.
English: Dizziness*
Maltese: Prurite*
English: Colitisg
Maltese: Koliteg
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.
Maltese: L-Evalwazzjoni Funzjonali tal-Kura għall-Kanċer-Melanoma (FACT-M, Functional Assessment of Cancer Therapy-Melanoma), il-kwestjonarju ewlieni tal-kwalità tal-ħajja tal-Organizzazzjoni Ewropea għar-Riċerka u l-Kura tal-Kanċer (EORTC QLQ-C30) u l-eżami EuroQoL-5 tal-Livell Dimensjoni-5
English: As encorafenib is not recommended in patients with moderate (Child Pugh B) and severe hepatic impairment (Child Pugh C), administration of binimetinib is not recommended in these patients (see sections 4.2 and 5.2).
Maltese: Peress li encorafenib mhux irrakkomandat f'pazjenti b'indeboliment epatiku moderat (Child Pugh B) u sever (Child Pugh C), l-għoti ta' binimetinib mhux irrakkomandat f'dawn il-pazjenti (ara sezzjonijiet 4.2 u 5.2).
English: • Grade 3 or Grade 4
Maltese: • Grad 3 jew Grad 4
English: The recommended dose of Mektovi is 45 mg (3 tablets of 15 mg) twice daily, taken about 12 hours apart (corresponding to a daily dose of 90 mg).
Maltese: Id-doża rakkomandata ta' Mektovi hija 45 mg (3 pilloli ta' 15 mg) darbtejn kuljum li jittieħdu madwar 12-il siegħa minn xulxin (li tikkorrispondi għal doża ta' kuljum ta' 90 mg).
English: carbamazepine
Maltese: Dożi maqbuża
English: There are insufficient data to evaluate potential differences in the exposure of binimetinib by race or ethnicity.
Maltese: M'hemmx dejta biżżejjed biex jiġu evalwati d-differenzi potenzjali fl-esponiment ta' binimetinib skont ir-razza jew l-etniċità.
English: Transaminase increased*
Maltese: Żieda fit-transaminase*
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, the incidences of liver laboratory abnormalities are listed below:
Maltese: Fl-Istudju CMEK162B2301-Parti 2, fil-fergħa Combo 300, l-inċidenzi ta' anormalitajiet tallaboratorju fil-fwied huma elenkati hawn taħt:
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.
Maltese: Fil-popolazzjoni Combo 450 miġbura, uġigħ ta' ras seħħet f'21.5% (59/274) tal-pazjenti inkluż Grad 3
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.
Maltese: Fl-Istudju CMEK162B2301-Parti 2, fil-fergħa Combo 300, RPED ġiet osservata fi 12.5% (32/257) talpazjenti b'0.4% (1/257) b'avveniment ta' Grad 4.
English: Visual impairment, including vision blurred and reduced visual acuity, occurred in 21.5 % (59/274) of patients.
Maltese: Vista batuta, inkluż vista mċajpra u akutezza viżwali mnaqqsa seħħew f'21.5 % (59/274) tal-pazjenti.
English: CK elevation/rhabdomyolysis
Maltese: Severità tar-reazzjoni avversaa
English: A similar proportion of patients in each treatment arm received subsequent treatment with checkpoint inhibitors, mainly pembrolizumab, nivolumab and ipilimumab (34.4 % Combo 450 arm, 36.1 % encorafenib arm, 39.8 % vemurafenib arm).
Maltese: Proporzjon simili ta' pazjenti f'kull fergħa ta' kura rċivew kura sussegwenti b'inibituri tal-punt tal kontroll, prinċipalment pembrolizumab, nivolumab u ipilimumab (34.4 % fergħa ta' Combo 450,
English: Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A).
Maltese: Mhu meħtieġ l-ebda aġġustament fid-doża f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh A).
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.
Maltese: Dermatite acneiforme F'pazjenti kkurati bil-Combo 450, dermatite acneiforme seħħet f'4.4 % (12/274) tal-pazjenti, kienet ta' Grad 1 u 2 u l-ebda avveniment ma wassal għal twaqqif tal-kura.
English: Additionally, the combination of encorafenib and binimetinib prevented the emergence of treatment resistance in BRAF V600E mutant human melanoma xenografts in vivo.
Maltese: Barra minn hekk, il-kombinazzjoni ta' encorafenib u binimetinib ipprevjeniet id-dehra ta' reżistenza għall-kura fil-xenografts tal-melanoma tal-bniedem mutanti BRAFV600E in vivo.
English: Blood alkaline phosphatase increased Common Amylase increased
Maltese: Żieda fil-fosfatażi alkalina fid-demm Komuni Żieda fl-amilażi
English: In the pooled Combo 450 population, mostly mild asymptomatic blood CK elevation was reported in 27.0 % (74/274) of patients.
Maltese: Fil-popolazzjoni Combo 450 miġbura, elevazzjoni ta' CK fid-demm l-aktar ħafifa asintomatika ġiet irrappurtata f'27.0 % (74/274) tal-pazjenti.
English: An increased litter incidence of foetal ventricular septal defects and pulmonary trunk alterations was noted at the highest doses.
Maltese: difetti settali ventrikolari fil-fetu u bidliet fl-arterja pulmonari.
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.
Maltese: Għeja Fil-popolazzjoni Combo 450 miġbura, għeja seħħet fi 43.8% (120/274) tal-pazjenti inkluż Grad 3 fi
English: Abdominal pain was reported in 27.4 % (75/274) of patients and was Grade 3 in 2.6 % (7/274) patients.
Maltese: L-uġigħ addominali ġie rrappurtat f'27.4 % (75/274) tal-pazjenti u kien ta' Grad 3 fi 2.6 % (7/274) tal-pazjenti.
English: What you need to know before you take Mektovi 3.
Maltese: X'għandek tkun taf qabel ma tieħu Mektovi 3.
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).
Maltese: Il-kejl tar-riżultat tal-effikaċja primarja kien sopravivenza ħielsa minn progressjoni (PFS, progressionfree survival) ta' Combo 450 mqabbla ma' vemurafenib kif ivvalutat minn kumitat ta' reviżjoni indipendenti blinded (BIRC, blinded independent review committee).
English: • If the LVEF does not recover within 4 weeks, binimetinib should be permanently discontinued.
Maltese: • Jekk il-LVEF ma jirkuprax fi żmien 4 ġimgħat, binimetinib għandu jitwaqqaf b'mod permanenti.
English: For additional information on warnings and precautions associated with encorafenib treatment, see section 4.4 of encorafenib SmPC.
Maltese: Għal informazzjoni addizzjonali dwar ittwissijiet u l-prekawzjonijiet assoċjati ma' kura b'encorafenib, ara sezzjoni 4.4 tal-SmPC ta'
English: The median duration of exposure was 11.7 months in patients treated with Combo 450, 7.1 months in patients treated with encorafenib 300 mg and 6.2 months in patients treated with vemurafenib.
Maltese: Id-durata medjana tal-esponiment kienet ta' 11.7 xhur f'pazjenti kkurati b'Combo 450, 7.1 xhur f'pazjenti kkurati b'encorafenib 300 mg u 6.2 xhur f'pazjenti kkurati b'vemurafenib.
English: Therapy should be discontinued if the patient is not able to tolerate 30 mg orally twice daily.
Maltese: It-terapija għandha titwaqqaf jekk il-pazjent ma jkunx jista' jittollera 30 mg oralment darbtejn kuljum.
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).
Maltese: L-okkorrenza ta' RPED sintomatiku tista' tiġi mmaniġġjata b'interruzzjoni fil-kura, tnaqqis fid-doża jew bi twaqqif tal-kura (ara Tabella 1 f'sezzjoni 4.2).
English: Dose re-escalation to 45 mg twice daily is not recommended if the dose reduction is due to left ventricular dysfunction (LVD) or any Grade 4 toxicity.
Maltese: 45 mg darbtejn kuljum mhijiex irrakkomandata jekk it-tnaqqis fid-doża jkun minħabba disfunzjoni ventrikolari tax-xellug (LVD) jew kwalunkwe tossiċità ta' Grad 4.
English: Basal cell carcinoma*
Maltese: Karċinoma taċ-ċellula bażali*
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.
Maltese: Fl-Istudju CMEK162B2301-Parti 2, fil-fergħa Combo 300, avvenimenti emorraġiċi ġew osservati f'6.6% (17/257) tal-pazjenti u kienu ta' Grad 3-4 f'1.6% (4/257) tal-pazjenti.
English: Binimetinib is a weak inhibitor of OAT3, and caution should be taken when it is used with sensitive substrates (such as pravastatin or ciprofloxacin).
Maltese: Binimetinib hu inibitur dgħajjef ta' OAT3 u għandu jkun hemm kawtela meta jintuża ma' sottostrati sensittivi (bħal pravastatin jew ciprofloxacin).
English: Fatal gastric ulcer haemorrhage with multiple organ failure as a concurrent cause of death, occurred in one patient.
Maltese: F'pazjent wieħed seħħet emorraġija ta' ulċera gastrika fatali b'insuffiċjenza tal-organu multipla bħala kawża konkurrenti ta' mewt.
English: If binimetinib is temporarily interrupted, encorafenib should be reduced to 300 mg once daily during the time of binimetinib dose interruption (see Tables 1 and 2) as encorafenib is not well-tolerated at the dose of 450 mg as a single agent.
Maltese: Jekk binimetinib jiġi interrott temporanjament, encorafenib għandu jitnaqqas għal 300 mg darba kuljum waqt il-perjodu ta' interruzzjoni tad-doża ta' binimetinib (ara Tabelli 1 u 2) peress li encorafenib ma jiġix ittollerat sew bid-doża ta' 450 mg bħala aġent uniku.
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.
Maltese: Bid-doża rakkomandata (n = 274) f'pazjenti b'melanoma li ma tistax titneħħa jew metastatika, ir-reazzjonijiet avversi l-aktar komuni (> 25 %) li seħħew f'pazjenti kkurati b'binimetinib mogħti ma' encorafenib kienu għeja, nawsja, dijarea, rimettar, distakkament tar-retina, uġigħ addominali, artralġja, żieda fis-CK fid-demm u mijalġija.
English: • Liver problems: Mektovi can cause abnormal blood tests related to your liver (raised levels of liver enzymes).
Maltese: • Problemi fil-fwied: Mektovi jista' jikkawża testijiet tad-demm mhux normali relatati mal fwied tiegħek (livelli elevati ta' enzimi tal-fwied).
English: Few patients requiring dose interruptions or dose reductions (0.7 % or 2/274).
Maltese: Ftit pazjenti kienu jeħtieġu interruzzjonijiet fid-doża jew tnaqqis fid doża (0.7 % jew 2/274).
English: - The other ingredients are:
Maltese: Problemi ta' fsada:
English: Cutaneous squamous cell carcinomaa
Maltese: Karċinoma taċ-ċelluli skwamużi talġildaa
English: There are no data on the effect on fertility in humans for binimetinib.
Maltese: Effetti ta' prodotti mediċinali oħra fuq binimetinib.
English: • a medicine for carcinoma treatment called sorafenib
Maltese: • mediċina għall-kura tal-karċinoma msejħa sorafenib
English: Mektovi contains lactose
Maltese: Mektovi fih lattożju
English: • Grade 4 PE
Maltese: • PE ta' Grad 4
English: Hypertension*
Maltese: Ipertensjoni *
English: Table 2: Recommended dose modifications for binimetinib (used in combination with encorafenib) for other adverse reactions
Maltese: Tabella 2: Modifikazzjonijiet fid-doża rrakkomandati għal binimetinib (użat flimkien ma' encorafenib) għal reazzjonijiet avversi oħra