FrancophonIA/ELRC3.0 huggingface dataset:
English: In the integrated safety population of patients with melanoma and advanced NSCLC, cuSCC occurred in 2% (19/1076) of patients receiving dabrafenib in combination with trametinib.
Maltese: Filpopolazzjoni ta' sigurtà integrata tal-pazjenti b'melanoma u NSCLC avvanzat, cuSCC seħħ fi 2% (19/1076) tal-pazjenti li ngħataw dabrafenib flimkien ma' trametinib.
English: The proportion of patients experiencing AEs was similar in those aged <65 years and those aged ≥65 years in all clinical trials.
Maltese: Il-proporzjon ta' pazjenti li esperjenzaw AEs kien simili f'dawk fl-età ta' < 65 sena u f'dawk fl-età ta' ≥ 65 sena fil-provi kliniċi kollha.
English: Table 9 Efficacy results for Study MEK116513 (COMBI-v)
Maltese: Tabella 9 Riżultati tal-effikaċja għall-Istudju MEK116513 (COMBI-v)
English: Haemorrhagic events, including major haemorrhagic and fatal haemorrhages, have occurred in patients taking the combination of dabrafenib with trametinib (see section 4.8).
Maltese: Avvenimenti emorraġiċi, inklużi avvenimenti emorraġiċi ewlenin u emorraġiji fatali, seħħew f'pazjenti li kienu qegħdin jieħdu l-kombinazzjoni ta' dabrafenib ma' trametinib (ara sezzjoni 4.8).
English: When dabrafenib is used in combination with trametinib refer to the guidance for medicinal product interactions found in sections 4.4 and 4.5 of dabrafenib and trametinib SmPC.
Maltese: Meta dabrafenib jintuża flimkien ma' trametinib, irreferi għall-gwida għal interazzjonijiet tal-prodotti mediċinali misjuba f'sezzjonijiet 4.4 u 4.5 tal-SmPC ta' dabrafenib u trametinib.
English: Cohorts were enrolled sequentially:
Maltese: Il-gruppi kienu rreġistrati f'sekwenza:
English: In the Phase III study MEK115306 no patients treated with trametinib in combination with dabrafenib had worst-case QTcB prolongation to >500 msec; QTcB was increased more than 60 msec from baseline in 1% (3/209) of patients.
Maltese: Fl-istudju tal-Fażi III MEK115306, ebda pazjent ikkurat bi trametinib flimkien ma' dabrafenib ma kellu l-agħar każ ta' titwil tal-QTcB sa > 500 msek; QTcB żdied b'aktar minn 60 msek mil-linja bażi f'1 % (3/209) tal-pazjenti.
English: Similar results were seen in the 45 patients who crossed over from dabrafenib monotherapy to the trametinib 2 mg once daily and dabrafenib 150 mg twice daily combination in Part C of this study.
Maltese: Ġew osservati riżultati simili fil-45 pazjent li qasmu mill-monoterapija b'dabrafenib għat-terapija b'kombinazzjoni ta' trametinib 2 mg darba kuljum u dabrafenib 150 mg darbtejn kuljum fil-Parti Ċ ta' dan l-istudju.
English: All Treated Subjects Population BRAF V600E (Primary)
Maltese: Il-Popolazzjoni ta' Suġġetti Kkurati Kollha BRAF V600E (Primarja)
English: Treatment with anti-pyretics such as ibuprofen or acetaminophen/paracetamol should be initiated.
Maltese: Għandha tinbeda kura b'antipyretics bħal ibuprofen jew acetaminophen/paracetamol.
English: Non-clinical and clinical trials with retrospective bi-directional Sanger sequencing analyses have shown that the test also detects the less common BRAF V600D mutation and V600E/K601E mutation with lower sensitivity.
Maltese: Provi kliniċi u mhux kliniċi b'analiżi ta' sekwenzar Sanger retrospettiv u bidirezzjonali wrew li t-test jiskopri wkoll il-mutazzjoni l-inqas komuni BRAF V600D u l-mutazzjoni V600E/K601E b'anqas sensittività.
English: RAS-associated malignancies have been reported in clinical trials, both with another BRAF inhibitor (chronic myelomonocytic leukaemia and non-cutaneous SCC of the head and neck) as well as with dabrafenib monotherapy (pancreatic adenocarcinoma, bile duct adenocarcinoma) and with dabrafenib in combination with the MEK inhibitor, trametinib (colorectal cancer, pancreatic cancer).
Maltese: Ġew irrapportati malinni assoċjati ma' RAS fi provi kliniċi, kemm ma' inibitur BRAF ieħor (lewkimja majelomonoċitika kronika u SCC mhux kutanji tar-ras u tal-għonq) kif ukoll ma' monoterapija b'dabrafenib (adenokarċinoma pankreatika, adenokarċinoma fil-kanal tal-bila) u ma' dabrafenib f'kombinazzjoni mal-inibitur tal-MEK, trametinib (kanċer kolorettali, kanċer tal-frixa).
English: Age greater than 75 years was a significant predictor of carboxy- and desmethyl-dabrafenib plasma concentrations with a 40% greater exposure in subjects ≥75 years of age, relative to subjects <75 years old.
Maltese: Età ta' aktar minn 75 sena kienet bassar sinifikanti ta' konċentrazzjonijiet fil-plażma ta' carboxy- u desmethyl-dabrafenib b'espożizzjoni ta' 40 % ogħla f'individwi li għandhom 75 sena u aktar, meta mqabbel ma' individwi li għandhom inqas minn 75 sena.
English: • tiredness
Maltese: • Sturdament
English: Data cut-off: 8
Maltese: 1 data cut-off: 8 ta' Awwissu 2016
English: The 5-year overall survival rate was 40% (95% CI: 31.2, 48.4) in the combination arm versus 33% (95% CI: 25.0, 41.0) in the dabrafenib monotherapy arm for patients who had a normal lactate dehydrogenase level at baseline, and 16% (95% CI: 8.4, 26.0) in the combination arm versus 14% (95% CI: 6.8, 23.1) in the dabrafenib monotherapy arm for patients with an elevated lactate dehydrogenase level at baseline.
Maltese: 0, 41.0) fil-fergħa mogħtija monoterapija b'dabrafenib f'każ ta' pazjenti b'livell ta' lactate dehydogenase normali fil-linja bażi u 16% (95% CI: 8.4, 26.0) fil-fergħa tal-kombinazzjoni kontra 14% (95% CI: 6.8, 23.1) fil-fergħa mogħtija monoterapija b'dabrafenib f'każ ta' pazjenti b'livell għoli ta' lactate dehydogenase fil-linja bażi.
English: Based on exposure, relative potency, and pharmacokinetic properties, both hydroxy- and desmethyl-dabrafenib are likely to contribute to the clinical activity of dabrafenib while the activity of carboxy-dabrafenib is not likely to be significant.
Maltese: Ibbażat fuq espożizzjoni, potenza relattiva, u l-proprjetajiet farmakokinetiċi, kemm dabrafenib-hydroxy u desmethyl-x'aktarx li jikkontribwixxu għall-attività klinika ta' dabrafenib, filwaqt li l-attività ta' carboxy-dabrafenib mhijiex probabbli li tkun sinifikanti.
English: • muscle pain
Maltese: • Spażmi fil-muskoli
English: In the previously treated population, 38 patients (67%) had one line of systemic anti-cancer therapy for metastatic disease.
Maltese: Fil-popolazzjoni kkurata qabel, 38 pazjent (67%) kellhom tip wieħed ta' terapija sistemika kontra l-kanċer għal mard metastatiku.
English: Cutaneous squamous cell carcinoma b
Maltese: Karċinoma taċ-ċelluli skwamużi talġilda b
English: Combination with trametinib
Maltese: Kombinazzjoni ma' trametinib
English: 5-year OS analysis (data cut-off: 10-Dec-2018)
Maltese: Analiżi fuq 5 snin (data tal-limitu: 10-Diċ-2018)
English: • Low levels of phosphate (hypophosphataemia) in the blood
Maltese: • Livelli baxxi ta' fosfat (ipofosfatimja) fid-demm
English: In juvenile toxicity studies in rats, effects on growth (shorter long bone length), renal toxicity (tubular deposits, increased incidence of cortical cysts and tubular basophilia and reversible increases in urea and/or creatinine concentrations) and testicular toxicity (degeneration and tubular dilation) were observed (≥0.2 times adult human clinical exposure based on AUC).
Maltese: Fi studji tal-effett tossiku fuq iż-żgħar fil-firien, kienu osservati effetti fuq it-tkabbir (tul iqsar talgħadam it-twil), tossiċità renali (depożiti tubulari, żieda fl-inċidenza ta' ċisti kortikali u bażofilja tubulari u żidiet riversibbli fl-urea u/jew fil-konċentrazzjonijiet tal-krejatinina) u effett tossiku fuq ittestikoli (deġenerazzjoni u dilazzjoni tubulari) (≥ 0.2 drabi l-espożizzjoni klinika f'individwi adulti msejsa fuq l-AUC).
English: Adjuvant treatment of Stage III melanoma
Maltese: Trattament adjuvanti ta' melanoma fi Stadju III
English: • medicines to treat cancer, such as cabazitaxel
Maltese: • mediċini għall-kura tal-kanċer, bħal cabazitaxel
English: Table 10 Efficacy data by investigator assessment from COMBI-MB study
Maltese: Tabella 10 L-effikaċja tad-dejta skont l-evalwazzjoni tal-investigatur mill-istudju COMBI-MB
English: In the combination therapy arm of study MEK115306 in patients with unresectable or metastatic melanoma, pyrexia was reported in 57% (119/209) of patients with 7% Grade 3, as compared to the dabrafenib monotherapy arm with 33% (69/211) of patients reporting pyrexia, 2% Grade 3.
Maltese: Fil-fergħa tat-terapija ta' kombinazzjoni tal-istudju MEK115306 f'pazjenti b'melanoma li ma tistax titneħħa b'intervent kirurġiku jew metastatika, id-deni kien irrapportat f'57% (119/209) tal-pazjenti b'7% fil-Grad 3, imqabbla mal-fergħa tal-monoterapija b'dabrafenib, fejn id-deni kien irrapportat f'33% (69/211) talpazjenti bi 2% fil-Grad 3.
English: Hepatic adverse events have been reported in clinical trials with dabrafenib in combination with trametinib (see section 4.8).
Maltese: Avvenimenti avversi epatiċi ġew irrapportati fi provi kliniċi b'dabrafenib flimkien ma' trametinib (ara sezzjoni 4.8).
English: Call your doctor or nurse and get medical help right away if you have any unusual signs of bleeding, including:
Maltese: Ċempel lit-tabib/a jew infermier/a tiegħek u ikseb għajnuna medika minnufih jekk ikollok xi sinjali mhux tas-soltu ta' fsada, inkluż:
English: Focal arterial/perivascular inflammation in various tissues was observed in mice and an increased incidence of hepatic arterial degeneration and spontaneous cardiomyocyte degeneration with inflammation (spontaneous cardiomyopathy) was observed in rats (≥0.5 and 0.6 times clinical exposure for rats and mice respectively).
Maltese: Fil-ġrieden, kienet osservata infjammazzjoni fokali fl-arterji/perivaskulari f'diversi tessuti u fil-firien kienet osservata żieda flinċidenza tad-deġenerazzjoni tal-arterji tal-fwied u deġenerazzjoni spontanja tal-kardjomijoċiti b'infjammazzjoni (kardjomijopatija spontanja) (≥ 0.5 u 0.6 drabi l-esponiment kliniku għall-firien u għall-ġrieden rispettivament).
English: Studies in juvenile animals have shown adverse effects of dabrafenib which had not been observed in adult animals (see section 5.3).
Maltese: Studji fuq annimali żgħar wrew effetti avversi ta' dabrafenib li ma kinux osservati f'annimali adulti (ara sezzjoni 5.3).
English: The trametinib 2 mg once daily and dabrafenib 150 mg twice daily combination demonstrated limited clinical activity in patients who had progressed on a BRAF inhibitor.
Maltese: Il-kombinazzjoni ta' trametinib 2 mg darba kuljum u dabrafenib 150 mg darbtejn kuljum uriet attività klinika limitata f'pazjenti li wrew progress fuq inibitur BRAF.
English: The assay was designed to detect the BRAF V600E and V600K mutations with high sensitivity (down to 5% V600E and V600K sequence in a background of wild-type sequence using DNA extracted from FFPE tissue).
Maltese: L-analiżi kienet maħsuba biex tidentifika l-mutazzjonijiet V600E u V600K BRAF b'sensittività għolja (sa 5 % ta' sekwenza V600E u V600K fi sfond ta' sekwenza ta' tip selvaġġ billi jintuża DNA estratt minn tessut FFPE).
English: Most subjects were Caucasian (>99%) and male (53%), with a median age of 56 years (28% were ≥65 years).
Maltese: Il-biċċa l-kbira tal-individwi kienu Kawkasi (>99 %) u Rġiel (53 %), b'età medja ta' 56 sena (28 % kellhom l-età ta' ≥ 65 sena).
English: Tafinlar in combination with trametinib can result in the breakdown of muscle (rhabdomyolysis).
Maltese: Tafinlar flimkien ma' trametinib jista' jirriżulta fit-tkissir tal-muskolu (rabdomijolosi).
English: No clinically relevant effect of dabrafenib or its metabolites on the QTc interval was observed.
Maltese: Ma kien osservat l-ebda effett relevanti klinikament ta' dabrafenib jew il-metaboliti tiegħu fuq l-intervall tal-QTc.
English: In 1% of patients receiving dabrafenib as monotherapy in the integrated safety population, serious non-infectious febrile events were identified as fever accompanied by severe rigors, dehydration, hypotension and/or acute renal insufficiency or pre-renal origin in subjects with normal baseline renal function.
Maltese: F'1 % tal-pazjenti li ngħataw dabrafenib bħala monoterapija fil-popolazzjoni ta' sigurtà integrata, avvenimenti serji mhux infettivi ta' deni ġew definiti bħala deni akkumpanjat minn tertir sever, deidratazzjoni, pressjoni baxxa u/jew insuffiċjenza renali akuta ta' oriġini pre-renali f'individwi b'funzjoni renali normali fil-linja bażi.
English: The safety profile from MEK116513 is generally similar to that of MEK115306 with the following exceptions: 1) The following adverse reactions have a higher frequency category as compared to MEK115306: muscle spasm (very common); renal failure and lymphoedema (common); acute renal failure (uncommon); 2) The following adverse reactions have occurred in MEK116513 but not in MEK115306: cardiac failure, left ventricular dysfunction, interstitial lung disease (uncommon).
Maltese: 1) Ir-reazzjonijiet mhux mixtieqa li ġejjin għandhom kategorija ta' frekwenza ogħla meta mqabbel ma' MEK115306: spażmi fil-muskoli (komuni ħafna); insuffiċjenza renali u limfoedema (komuni); insuffiċjenza renali akuta (mhux komuni); 2) Ir-reazzjonijiet mhux mixtieqa li ġejjin seħħew f'MEK116513 imma mhux f'MEK115306: insuffiċjenza kardijaka, disfunzjoni ventrikulari tax-xellug, mard interstizjali tal-pulmun (mhux komuni); 3) Ir-reazzjonijiet mhux mixtieqa li ġejjin seħħew f'MEK116513 u BRF115532 imma mhux f'MEK115306 u BRF113928: rabdomijolożi(mhux komuni)
English: Medicinal products that alter the pH of the upper gastrointestinal (GI) tract (e.g. proton pump inhibitors, H2-receptor antagonists, antacids) are not expected to reduce the bioavailability of dabrafenib.
Maltese: Prodotti mediċinali li jbiddlu l-pH tal-parti ta' fuq tal-passaġġ gastrointestinali (GIgastrointestinal) (eż. inibituri tal-pompa tal-protoni, antagonisti tar-riċettur ta' H2, antaċidi) mhumiex mistennija li jnaqqsu l-bijodisponibilità ta' dabrafenib.
English: Median PFS (months) (95% CI)
Maltese: PFS medja (xhur) (95 % CI)
English: Caution should be exercised and additional monitoring of digoxin is recommended when digoxin (a transporter substrate) is used concomitantly with dabrafenib and at discontinuation of dabrafenib (see section 4.5).
Maltese: Għandha tiġi eżerċitata kawtela u huwa rakkomandat li jsir monitoraġġ addizzjonali ta' digoxin meta digoxin (substrat trasportatur) meta dabrafenib jintuża flimkien ma' warfarin u wara waqfien ta' dabrafenib (ara sezzjoni 4.5).
English: Tafinlar 75 mg capsules dabrafenib
Maltese: Tafinlar 75 mg kapsuli dabrafenib
English: Most subjects were Caucasian (>96%) and male (55%), with a median age of 55 years (24% were ≥65 years).
Maltese: Ilbiċċa l-kbira tal-individwi kienu Kawkasi (>96 %) u Rġiel (55 %), b'età medja ta' 55 sena (24 % kellhom l-età ta' ≥ 65 sena).
English: Combination 2
Maltese: F'sena 2
English: • some medicines used for pain relief, such as fentanyl and methadone
Maltese: • xi mediċini użati għat-tnaqqis tal-uġigħ, bħal fentanyl u methadone
English: In these patients a 13% (95 CI: 5.0, 27.0) confirmed response rate was observed with a median PFS of 3.6 months (95% CI: 2, 4).
Maltese: F'dawn il-pazjenti ġiet osservata rata ta' rispons ikkonfermata ta' 13 % (95 % CI: 5.0, 27.0) b'PFS medja ta' 3.6 xhur (95 % CI: 2, 4).
English: • Low levels of sodium (hyponatraemia) or phosphate (hypophosphataemia) in the blood
Maltese: • Livelli baxxi ta' sodju (iponatremja) jew fosfat (ipofosfatemja) fid-demm
English: New primary melanomas have been reported in clinical trials in patients treated with dabrafenib.
Maltese: Melanomi primarji ġodda ġew irrapportati fi provi kliniċi f'pazjenti kkurati b'dabrafenib.
English: In addition, older patients experienced more serious adverse reactions compared to younger patients (41% versus 22%).
Maltese: Barra minn hekk, pazjenti akbar fl-età esperjenzaw aktar reazzjonijiet avversi serji meta mqabbla ma' pazjenti iżgħar fl-età (41 % kontra 22 %).
English: Left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction If dabrafenib is being used in combination with trametinib and absolute decrease of >10% in LVEF compared to baseline and the ejection fraction is below the institution's lower limit of normal (LLN), please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Maltese: Tnaqqis tal-frazzjoni tal-ħruġ ventrikolari tax-xellug (LVEF)/ disfunzjoni ventrikulari tax-xellug Jekk dabrafenib qiegħed jintuża flimkien ma' trametinib u tnaqqis assolut ta' > 10% fl-LVEF meta mqabbel mal-linja bażi u l-frazzjoni tal-ħruġ huwa taħt il-limitu minimu tal-istituzzjoni tan-normal (LLN), jekk jogħġbok irreferi għall-SmPC ta' trametinib (ara sezzjoni 4.2) għal struzzjonijiet dwar ilmodifika fid-doża għal trametinib.
English: Following co-administration of a single dose of rosuvastatin (OATP1B1, OATP1B3 and BCRP substrate) with repeat-dose dabrafenib 150 mg twice daily in 16 patients, Cmax of rosuvastatin increased 2.6-fold whereas the AUC was only minimally changed (7% increase).
Maltese: Wara l-għoti ta' doża waħda ta' rosuvastatin (OATP1B1, OATP1B3 u sottostrat ta' BCRP) flimkien ma' doża ripetuta ta' dabrafenib 150 mg darbtejn kuljum f'16-il pazjent, Cmax ta' rosuvastatin żdiedet bi 2.6 darbiet filwaqt li l-AUC inbidlet bi ftit biss (żieda ta' 7%).
English: Tafinlar 50 mg capsules dabrafenib
Maltese: Tafinlar 50 mg kapsuli dabrafenib
English: Adjusted hazard ratio (95% CI) p-value
Maltese: Proporzjon ta' periklu (95% CI) valur-p
English: • blurred vision
Maltese: • telf tal-vista
English: Includes drug hypersensitivity f
Maltese: Tinkludi sensittività eċċessiva għall-mediċina f
English: Renal failure due to pyrexia-associated pre-renal azotaemia or granulomatous nephritis was uncommon; however dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN).
Maltese: Insuffiċjenza renali minħabba ażotemija pre-renali assoċjata mad-deni jew nefrite granulomatika ma kinitx komuni; madankollu dabrafenib ma ġiex studjat f'pazjenti b'insuffiċjenza renali (definita bħala kreatinina > 1.5 x ULN).
English: Terminal half-life of dabrafenib following an intravenous single microdose is 2.6 hours.
Maltese: Il-half-life terminali ta' dabrafenib wara mikrodoża waħda ġol-vina hija ta' 2.6 sigħat.
English: Constipation
Maltese: Nefrite
English: These results did not meet the pre-specified boundary to claim statistical significance at this first OS interim analysis (HR=0.50; p=0.000019).
Maltese: Dawn irriżultati ma laħqux il-bordura speċifikata minn qabel sabiex jitqiesu li għandhom sinjifikat statistiku fl-ewwel analiżi interim tal-OS (HR=0.50; p=0.000019).
English: Fever has been reported in clinical trials with dabrafenib as monotherapy and in combination with trametinib (see section 4.8).
Maltese: Id-deni kien irrapportat fi provi kliniċi b'dabrafenib bħala monoterapija u flimkien ma' trametinib (ara sezzjoni 4.8).
English: After an oral dose, the major route of elimination of dabrafenib is metabolism, mediated via CYP3A4 and CYP2C8.
Maltese: Wara doża orali, ir-rotta ewlenija tal-eliminazzjoni ta' dabrafenib huwa l-metaboliżmu, medjat minn CYP3A4 u CYP2C8.
English: MEK115306 was a Phase III, randomised, double-blinded study comparing the combination of dabrafenib and trametinib to dabrafenib and placebo in first-line therapy for subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma.
Maltese: MEK115306 kien studju randomizzat u double-blinded tal-Fażi III li jqabbel il-kombinazzjoni ta' dabrafenib u trametinib ma' dabrafenib u plaċebo f'terapija tal-ewwel linja għal individwi b'melanoma tal-ġilda pożittiva għal mutazzjoni BRAF V600E/K li ma tistax titneħħa (Stadju IIIC) jew metastatika (Stadju IV).
English: In the Phase III clinical trials MEK115306 and MEK116513 in patients with unresectable or metastatic melanoma, cuSCC occurred in 10% (22/211) of patients receiving dabrafenib as a monotherapy and in 18% (63/349) of patients receiving vemurafenib as a monotherapy, respectively.
Maltese: Fil-provi kliniċi tal-Fażi III MEK115306 u MEK116513 f'pazjenti b'melanoma li ma tistax titneħħa b'intervent kirurġiku jew metastatika, cuSCC dehret f'10% (22/211) tal-pazjenti li ngħataw dabrafenib bħala monoterapija u fi 18% (63/349) tal-pazjenti li ngħataw vemurafenib bħala monoterapija, rispettivament.
English: (95% CI: 22.5, 34.6) in the vemurafenib monotherapy arm for patients who had a normal lactate dehydrogenase level at baseline, and 16% (95% CI: 9.3, 23.3) in the combination arm versus 10% (95% CI: 5.1, 17.4) in the vemurafenib monotherapy arm for patients with an elevated lactate dehydrogenase level at baseline.
Maltese: 38.8, 52.0) fil-fergħa ta' kombinazzjoni kontra 28% (95% CI: 22.5, 34.6) fil-fergħa mogħtija monoterapija b'vemurafenib f'każ ta' pazjenti b'livell ta' lactate dehydogenase normali fil-linja bażi u 16% (95% CI: 9.3, 23.3) fil-fergħa tal-kombinazzjoni kontra 10% (95% CI: 5.1, 17.4) fil-fergħa mogħtija monoterapija b'vemurafenib f'każ ta' pazjenti b'livell għoli ta' lactate dehydogenase fil-linja bażi.
English: Take Tafinlar capsules and trametinib tablets with you when possible.
Maltese: Ħu l-kapsuli ta' Tafinlar u l-pilloli ta' trametinib miegħek meta jkun possibbli.
English: Administration of gemfibrozil (a CYP2C8 inhibitor) 600 mg twice daily, with dabrafenib 75 mg twice daily, resulted in a 47% increase in dabrafenib AUC but did not alter dabrafenib Cmax relative to administration of dabrafenib 75 mg twice daily alone.
Maltese: L-għoti ta' gemfibrozil (inibitur ta' CYP2C8) 600 mg darbtejn kulljum ma' dabrafenib 75 mg darbtejn kuljum, irriżulta f'żieda ta' 47 % fl-AUC ta' dabrafenib iżda ma bidilx is-Cmax ta' dabrafenib meta mqabbel mal-għoti ta' dabrafenib 75 mg darbtejn kuljum waħdu.
English: In clinical trials ophthalmologic reactions, including uveitis, iridocyclitis and iritis, have been reported in patients treated with dabrafenib as monotherapy and in combination with trametinib.
Maltese: Fi provi kliniċi, ġew irrapportati reazzjonijiet oftalmoloġiċi, inkluż uveite, iridoċiklite u irite, f'pazjenti kkurati b'dabrafenib bħala monoterapija u flimkien ma' trametinib.
English: • have any liver problems.
Maltese: • għandekx jew qattx kellek problemi fil-kliewi.
English: N=1 2.9 (NR, NR)
Maltese: N=1 2.9 (4.8, NR)
English: Hepatic adverse events have been reported in clinical trials with dabrafenib in combination with trametinib.
Maltese: Avvenimenti avversi epatiċi ġew irrapportati fi provi kliniċi b'dabrafenib flimkien ma' trametinib.
English: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg dabrafenib.
Maltese: Kull kapsula iebsa fiha dabrafenib mesilate ekwivalenti għal 50 mg dabrafenib.
English: Dabrafenib related material is excreted primarily in faeces, with 71% of an oral dose recovered in faeces; 23% of the dose was recovered in urine in the form of metabolites only.
Maltese: Il-materjal relatat ma' dabrafenib jitneħħa primarjament mal-ippurgar, b'71 % tad-doża orali rkuprata fl-ippurgar; 23 % tad-doża kienet irkuprata fl-awrina fil-forma ta' metaboliti biss.
English: Overall confirmed response n (%) (95% CI)
Maltese: Rispons ikkonfermat globali n (%) (95% CI)
English: Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of dabrafenib.
Maltese: Kull kapsula iebsa fiha dabrafenib mesilate ekwivalenti għal 75 mg dabrafenib.
English: These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
Maltese: Dan ir-raxx serju fil-ġilda jaf iseħħ wara deni u sintomi li jixbhu lill-influwenza (sindrome ta' Stevens-Johnson).
English: • have or have had any gastrointestinal problems such as diverticulitis (inflamed pouches in the colon) or metastases to the gastrointestinal tract.
Maltese: • għandek jew kellek xi problemi gastrointestinali bħal divertikulite (boroż infjammati fil-kolon) jew metastasi fil-passaġġ gastrointestinali.
English: Liver problems
Maltese: Problemi ta' fsada
English: Folliculitis
Maltese: Majalġja
English: 3rd dose reduction
Maltese: GĦAMLA KWALITATTIVA
English: Most patients were Caucasian (99%) and male (55%), with a median age of 51 years (18% were ≥65 years).
Maltese: Ilbiċċa l-kbira tal-pazjenti kienu Kawkasi (99%) u rġiel (55%), bl-età medja ta' 51 sena (18% kellhom ≥65 sena).
English: Adverse reactions
Maltese: RESPONSABBLI
English: • Dizziness
Maltese: • Dijarrea
English: Pain in extremity Muscle spasms i
Maltese: Uġigħ fl-estremitajiet Spażmi fil-muskoli i