FrancophonIA/ELRC3.0 huggingface dataset:
English: Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib.
Maltese: Mekinist 2 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha trametinib dimethyl sulfoxide ekwivalenti għal 2 mg ta' trametinib.
English: In the integrated safety population of trametinib in combination with dabrafenib, decreased LVEF has been reported in 6% (65/1076) of patients, with most cases being asymptomatic and reversible.
Maltese: Fil-popolazzjoni ta' sigurtà integrata ta' trametinib flimkien ma' dabrafenib, kien irrapportat tnaqqis f'LVEF f'6% (65/1076) talpazjenti, bil-biċċa l-kbira tal-każijiet ikunu asintomatiċi u riversibbli.
English: When trametinib is used in combination with dabrafenib see sections 4.4 and 4.5 of the dabrafenib SmPC for interactions.
Maltese: Meta trametinib jintuża flimkien ma' dabrafenib, ara sezzjonijiet 4.4 u 4.5 tal-SmPC ta' dabrafenib għall-interazzjonijiet.
English: Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, have occurred in patients taking trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Maltese: Avvenimenti emorraġiċi, inklużi avvenimenti emorraġiċi ewlenin u emorraġiji fatali, seħħew f'pazjenti li kienu qegħdin jieħdu trametinib bħala monoterapija u flimkien ma' dabrafenib (ara sezzjoni 4.8).
English: Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib.
Maltese: Mekinist 0.5 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha trametinib dimethyl sulfoxide ekwivalenti għal 0.5 mg ta' trametinib.
English: • Trametinib monotherapy
Maltese: • tisgħol / tirremetti bid-demm
English: Trametinib should be permanently discontinued in patients with Grade 3 or 4 left ventricular cardiac dysfunction or clinically significant LVEF reduction which does not recover within 4 weeks (see section 4.4).
Maltese: Trametinib għandu jitwaqqaf għal kollox f'pazjenti b'disfunzjoni kardijaka ventrikulari tax-xellug ta' Grad 3 jew 4 jew tnaqqis fl-LVEF klinikament sinifikanti li ma jirkuprax, fi żmien 4 ġimgħat (ara sezzjoni 4.4).
English: Dose modifications are not recommended for adverse reactions of cutaneous squamous cell carcinoma (cuSCC) or new primary melanoma (see dabrafenib SmPC for further details).
Maltese: Il-modifiki tad-doża mhumiex rakkomandati għal reazzjonijiet avversi ta' karċinoma taċ-ċelluli skwamużi tal-ġilda (cuSCC) jew ta' melanoma primarja ġdida (ara l-SmPC ta' dabrafenib għal aktar dettalji).
English: Alanine aminotransferase increased Blood alkaline phosphatase increased Blood creatine phosphokinase increased a
Maltese: Żieda fl-alanine aminotransferase Żieda fil-alkaline phosphatase fiddemm
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg trametinib.
Maltese: Kull pillola miksija b'rita fiha trametinib dimethyl sulfoxide ekwivalenti għal 2 mg ta' trametinib.
English: Progressive disease or death, n (%)
Maltese: Numru ta' pazjenti Mietu (episodju), n (%)
English: Face oedema Mucosal inflammation Asthenia
Maltese: Infezzjoni fl-apparat tal-awrina Ċellulite
English: Please refer to sections 4.4 and 4.8 of the dabrafenib SmPC.
Maltese: Jekk jogħġbok irreferi għal sezzjonijiet 4.4 u 4.8 tal-SmPC ta' dabrafenib.
English: Dry skin Pruritus Rash Erythema h
Maltese: - Is-sustanzi mhux attivi l-oħra huma
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 Kawkażjatiċi (99%) u rġiel (55%), bl-età medja ta' 51 sena (18% kellhom ≥65 sena).
English: Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets trametinib
Maltese: Informazzjoni għall-pazjent Mekinist 0.5 mg pilloli miksijin b'rita Mekinist 2 mg pilloli miksijin b'rita trametinib
English: Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 6.
Maltese: L-OS medjana u r-rati ta' sopravivenza stmati għal sena, sentejn, 3 snin, 4 snin u 5 snin huma ppreżentati f'Tabella 6.
English: When trametinib is used in combination with dabrafenib please refer to the dabrafenib SmPC (section 4.4).
Maltese: Meta trametinib jintuża flimkien ma' dabrafenib, jekk jogħġbok irreferi għall-SmPC ta' dabrafenib (sezzjoni 4.4.).
English: Trametinib must be withheld in patients with suspected ILD or pneumonitis, including patients presenting with new or progressive pulmonary symptoms and findings including cough, dyspnoea, hypoxia, pleural effusion, or infiltrates, pending clinical investigations.
Maltese: Trametinib għandu jitwaqqaf f'pazjenti b'ILD suspettat jew b'pulmonite suspettata, inklużi pazjenti li jippreżentaw sintomi u sejbiet pulmonari ġodda jew progressivi inklużi sogħla, qtugħ ta' nifs, ipoksja, effużjoni plewrali, jew infiltrati, sakemm isiru investigazzjonijiet kliniċi.
English: Hepatic adverse reactions have been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Maltese: Reazzjonijiet avversi epatiċi ġew irrapportati fi provi kliniċi bi trametinib bħala monoterapija u flimkien ma' dabrafenib (ara sezzjoni 4.8).
English: Extremadura, 3
Maltese: ANNESS III
English: P value f
Maltese: < 0.001f
English: The median time to onset of the first occurrence of haemorrhagic events for the combination of trametinib and dabrafenib was 94 days in the melanoma Phase III studies and 75 days in the NSCLC study for the patients who had received prior anti-cancer therapy.
Maltese: Il-potenzjal għal dawn l-avvenimenti f'pazjenti b'ammonti baxxi ta' plejtlits (< 75,000) ma ġiex stabbilit għaliex dawn il-pazjenti kienu esklużi mill-provi kliniċi.
English: Call your doctor or nurse and get medical help right away if you have any unusual signs of bleeding, including:
Maltese: Ċempel littabib/a jew infermier/a tiegħek u ikseb għajnuna medika minnufih jekk ikollok xi sinjali mhux tassoltu ta' fsada, inkluż:
English: Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, occurred in patients taking trametinib as monotherapy and in combination with dabrafenib.
Maltese: Avvenimenti emorraġiċi, inklużi avvenimenti emorraġiċi ewlenin u emorraġiji fatali, seħħew f'pazjenti li kienu qegħdin jieħdu trametinib bħala monoterapija u flimkien ma' dabrafenib.
English: separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) and swelling around the eyes
Maltese: Okklużjoni tal-vina retinali (RVO - retinal vein occlusion) u distakkament epiteljali tal-pigment retinali (RPED - Retinal pigment epithelial detachment)
English: Urinary tract infection Cellulitis
Maltese: Newtropenija Anemija
English: As metabolism and biliary excretion are the primary routes of elimination of trametinib, administration of trametinib should be undertaken with caution in patients with moderate to severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: Minħabba li l-metaboliżmu u l-eliminazzjoni mill-marrara huma r-rotot primarji ta' eliminazzjoni ta' trametinib, amministrazzjoni ta' trametinib għandha ssir b'kawtela f'pazjenti b'indeboliment tal-fwied minn moderat sa sever (ara sezzjonijiet 4.2 u 5.2).
English: Study MEK116513 was a 2-arm, randomised, open-label, Phase III study comparing dabrafenib and trametinib combination therapy with vemurafenib monotherapy in BRAF V600 mutation-positive unresectable or metastatic melanoma.
Maltese: L-istudju MEK116513 kien studju bejn 2 gruppi, randomizzat u open-label tal-Fażi III li qabbel itterapija b'kombinazzjoni ta' dabrafenib u trametinib mal-monoterapija b'vemurafenib f'pazjenti b'melanoma li ma tistax titneħħa b'intervent kirurġiku jew metastatika pożittiva għal mutazzjoni BRAF V600.
English: Pyrexia has been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib; however, the incidence and severity of pyrexia are increased with the combination therapy.
Maltese: Ġie rrapportat deni fi provi kliniċi bi trametinib bħala monoterapija u flimkien ma' dabrafenib; madankollu, l-inċidenza u s-severità tad-deni jiżdiedu bit-terapija kkombinata.
English: Disorders associated with visual disturbance, including RPED and RVO, may occur with trametinib as monotherapy and in combination with dabrafenib.
Maltese: Disturbi assoċjati ma' disturbi fil-vista, inklużi RPED u RVO, jistgħu jseħħu bi trametinib bħala monoterapija u flimkien ma' dabrafenib.
English: Renal impairment is unlikely to have a clinically relevant effect on trametinib pharmacokinetics given the low renal excretion of trametinib.
Maltese: Mhuwiex probabbli li indeboliment renali jkollu effett klinikament rilevanti fuq il-farmakokinetiċi ta' trametinib meta wieħed iqis li l-eliminazzjoni renali ta' trametinib hija baxxa.
English: Exceptions where dose modifications are necessary for only one of the two treatments are detailed below for pyrexia, uveitis, RAS mutation positive non-cutaneous malignancies (primarily related to dabrafenib), left ventricular ejection fraction (LVEF) reduction, retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) and interstitial lung disease (ILD)/pneumonitis (primarily related to trametinib).
Maltese: Jekk iseħħu tossiċitajiet relatati mal-kura meta trametinib jintuża flimkien ma' dabrafenib, mela allura ż-żewġ trattamenti għandu jkollhom id-doża mnaqqsa, interrotta jew imwaqqfa simultanjament. Leċċezzjonijiet, meta jkun hemm bżonn ta' modifika fid-doża għal wieħed biss miż-żewġ trattamenti, huma spjegati fid-dettall hawn taħt għal deni, uveite, tumuri malinni mhux tal-ġilda pożittivi għal mutazzjoni RAS (primarjament b'rabta ma' dabrafenib), tnaqqis tal-frazzjoni tal-ħruġ ventrikolari taxxellug (LVEF), okklużjoni tal-vina retinali (RVO), distakkament epiteljali tal-pigment retinali (RPED) u mard interstizjali tal-pulmun (ILD)/pulmonite (primarjament b'rabta ma' trametinib).
English: The efficacy and safety of the recommended dose of trametinib (2 mg once daily) in combination with dabrafenib (150 mg twice daily) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation was studied in two Phase III studies and one supportive Phase I/II study.
Maltese: L-effikaċja u s-sigurtà tad-doża rrakkomandata ta' trametinib (2 mg darba kuljum) flimkien ma' dabrafenib (150 mg darbtejn kuljum) għall-kura ta' pazjenti adulti b'melanoma metastatika jew li ma tistax titneħħa b'mutazzjoni BRAF V600 ġew studjati f'żewġ studji tal-Fażi III u fi studju ta' sostenn wieħed tal-Fażi I/II.
English: (7.5, NR) a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (≥59%) of investigator-assessed responses were still ongoing.
Maltese: (7.5, NR) a - Sopravivenza Mingħajr Progressjoni (ivvalutata mill-investigatur) b - Rata ta' Rispons Globali = Rispons Sħiħ + Rispons Parzjali ċ - Tul tar-Rispons d - Fil-ħin tar-rappurtar, il-maġġoranza (≥ 59%) tar-reazzjonijiet ivvalutati mill-investigatur kienu għadhom għaddejjin. e - Id-differenza tal-ORR ikkalkolata abbażi tar-riżultat tal-ORR mhux arrotondat f - L-analiżi aġġornata ma kenitx imfassla minn qabel u l-valur-p ma ġiex aġġustat għal ittestjar multiplu NR = Ma ntlaħaqx
English: The PFS result was consistent in the subgroup of patients with V600K mutation positive melanoma (HR=0.50; [95% CI: 0.18, 1.35], p=0.0788).
Maltese: Ir-riżultat PFS kien konsistenti fis-sottogrupp ta' pazjenti b'melanoma pożittiva għall-mutazzjoni V600K (HR = 0.50; \
English: Dehydration Hyponatraemia Hypophosphataemia Hyperglycaemia
Maltese: Żieda fl-alkaline phosphatase fiddemm
English: The Mekinist 2 mg film-coated tablets are pink, round, biconvex, with “GS” debossed on one face and “HMJ” on the opposing face.
Maltese: Mekinist 2 mg pilloli miksijin b'rita huma roża, tondi, bikonvessi b''GS' imnaqqxa fuq wiċċ wieħed u ‘HMJ' fuq in-naħa l-oħra.
English: (months) Median (95% CI)
Maltese: (xhur) Medju (95% CI)
English: • dizziness
Maltese: • Dijarrea
English: PFSa
Maltese: UŻU
English: A population pharmacokinetic analysis indicates that mildly elevated bilirubin and/or AST levels (based on National Cancer Institute [NCI] classification) do not significantly affect trametinib oral clearance.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tindika li livelli kemmxejn elevati ta' bilirubin u/jew AST (abbażi tal-klassiifkazzjoni tal-Istitut Nazzjonali tal-Kanċer [NCI]) ma taffettwax b'mod sinifikanti ttneħħija mill-ħalq ta' trametinib.
English: Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 8.
Maltese: L-OS medjana u r-rati ta' sopravivenza stmati għal sena, sentejn, 3 snin, 4 snin u 5 snin huma ppreżentati f'Tabella 8.
English: It is currently unknown if hormonal contraceptives are affected by trametinib.
Maltese: Attwalment mhuwiex magħruf jekk kontraċettivi ormonali humiex affettwati minn trametinib.
English: Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets
Maltese: Mekinist 0.5 mg pilloli miksijin b'rita Mekinist 2 mg pilloli miksijin b'rita
English: Hazard ratio (95% CI)
Maltese: Proporzjon talPeriklu (95% CI)
English: 1-year rate (95% CI)
Maltese: Rata ta' sena (95% CI)
English: Rhabdomyolysis
Maltese: L-anzjani
English: 3-year rate (95% CI)
Maltese: Rata ta' 3 snin (95% CI)
English: Animal studies have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali urew tossiċità riproduttiva (ara sezzjoni 5.3). Trametinib m'għandux jingħata lil nisa tqal.
English: • Inflammation of the lung (pneumonitis or interstitial lung disease)
Maltese: • Infjammazzjoni tal-pulmun (pulmonite jew mard interstizjali tal-pulmun)
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg or 2 mg of trametinib.
Maltese: Kull pillola miksija b'rita fiha trametinib dimethyl sulfoxide ekwivalenti għal 0.5 mg jew 2 mg ta' trametinib.
English: Grade (CTC-AE)* Recommended trametinib dose modifications Used as monotherapy or in combination with dabrafenib
Maltese: Grad (CTC-AE)* Bidliet rakkomandati fid-doża ta' trametinib Użat bħala monoterapija jew flimkien ma' dabrafenib
English: • Cohort A: Monotherapy (dabrafenib 150 mg twice daily), 84 patients enrolled.
Maltese: • Grupp A: Monoterapija (dabrafenib 150 mg darbtejn kuljum), 84 pazjent irreġistrati. 78 pazjent kienet ingħatatilhom kura sistemika preċedenti għall-mard metastatiku tagħhom.
English: Up to 3 in 100 people taking Mekinist in combination with dabrafenib may develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).
Maltese: Sa 3 minn kull 100 persuna li jkunu qegħdin jieħdu Mekinist flimkien ma' dabrafenib jistgħu jiżviluppaw tip differenti ta' kanċer tal-ġilda msejjaħ karċinoma taċ-ċelloli skwamużi tal-ġilda (cuSCC).
English: Mild and moderate renal impairment had no effect on trametinib exposure (<6% for either group).
Maltese: Indeboliment renali ħafif u moderat ma kellhom ebda effett fuq lespożizzjoni ta' trametinib (< 6% għal kull grupp).
English: In Cohort A of this study, trametinib did not demonstrate clinical activity in patients who had progressed on a prior BRAF inhibitor therapy.
Maltese: F'Grupp A ta' dan l-istudju, trametinib ma weriex attività klinika f'pazjenti li kienu urew progress fuq terapija ta' inibituri BRAF qabel.
English: In vitro and in vivo studies demonstrated that trametinib is metabolised predominantly via deacetylation alone or in combination with mono-oxygenation.
Maltese: Studji in vitro u in vivo wrew li trametinib huwa metabolizzat primarjament permezz ta' deaċetilitazzjoni waħdu jew flimkien ma' monossiġinazzjoni.
English: Tabulated list of adverse reactions
Maltese: Lista ppreżentata f'tabella tar-reazzjonijiet avversi
English: • dark-coloured urine
Maltese: • Infjammazzjoni tal-frixa
English: Name and address of the manufacturers responsible for batch release Glaxo Wellcome, S.A.
Maltese: Isem u indirizz tal-manifatturi responsabbli għall-ħruġ tal-lott
English: How should you take Mekinist in combination with dabrafenib
Maltese: It-teħid ta' Mekinist ma' dabrafenib:
English: In a single-arm Phase II study, designed to evaluate the objective response rate, safety, and pharmacokinetics following dosing of trametinib at 2 mg once daily in patients with BRAF V600E, V600K, or V600D mutation-positive metastatic melanoma (MEK113583), two separate cohorts were enrolled: Cohort A: patients with prior treatment with a BRAF inhibitor either with or without other prior therapy, Cohort B: patients with at least 1 prior chemotherapy or immunotherapy, without prior treatment with a BRAF inhibitor.
Maltese: II b'fergħa waħda, imfassal biex jevalwa r-rata ta' rispons oġġettiva, is-sigurtà, u lfarmakokinetika wara dożaġġ ta' trametinib 2.0 mg darba kuljum f'pazjenti b'melanoma metastatika pożittiva għal mutazzjoni BRAF V600E, V600K, jew V600D ta' BRAF (MEK113583), ġew irreġistrati żewġ gruppi separati:
English: An additional OS analysis was undertaken based upon the 20 May 2013 data cut, see Table 12.
Maltese: Saret analiżi addizzjonali tal-OS abbażi tal-qasma tad-dejta tal-20 ta' Mejju 2013, ara Tabella 12.
English: Progression-Free Survival
Maltese: Soppravvivenza Mingħajr Progressjoni
English: • Thickening of the outer layer of the skin (hyperkeratosis), patches of thick, scaly, or crusty skin
Maltese: • Żieda fil-kreatina phosphokinase, enzima li tinstab l-aktar fil-qalb, fil-moħħ u fil-muskoli skeletali
English: The median time to first presentation of ILD or pneumonitis was 160 days (range: 60 to 172 days).
Maltese: Il-ħin medjan għallewwel preżentazzjoni ta' ILD jew pulmonite kien ta' 160 jum (medda: 60 sa 172 jum).
English: Taking Mekinist or the combination of Mekinist and dabrafenib can cause serious bleeding including in your brain, the digestive system (such as stomach, rectum or intestine), lungs, and other organs, and can lead to death.
Maltese: It-teħid ta' Mekinist jew il-kombinazzjoni ta' Mekinist u dabrafenib jista' jikkawża fsada serja, inkluż f'moħħok, fis-sistema diġestiva (bħall-istonku, ir-rektum jew l-imsaren), fil-pulmun u f'organi oħrajn, filwaqt li jista' saħansitra jwassal għal mewt.
English: The bMx THxID BRAF assay is an allele-specific PCR performed on DNA extracted from FFPE tumour tissue.
Maltese: Il-prova bMx THxID BRAF hija PCR speċifika għall-allele mwettqa fuq DNA estratt minn tessut tat-tumur tal-FFPE.
English: Mekinist 2 mg film-coated tablets trametinib
Maltese: Mekinist 2 mg pilloli miksijin b'rita trametinib
English: Resume trametinib at a lower dose (reduced by 0.5 mg) or discontinue trametinib in patients taking trametinib 1 mg daily.
Maltese: Kompli trametinib b'doża aktar baxxa (imnaqqsa b' 0.5 mg) jew waqqaf trametinib f'pazjenti li jieħdu trametinib 1 mg kuljum.
English: Take Mekinist tablets and dabrafenib capsules with you when possible.
Maltese: Ħu l-pilloli ta' Mekinist u l-kapsuli ta' dabrafenib miegħek meta jkun possibbli.
English: In clinical trials, the median time to onset of the first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 and 5 months.
Maltese: Fi provi kliniċi, il-ħin medju għall-ewwel okkorrenza ta' disfunzjoni ventrikulari tax-xellug, insuffiċjenza kardijaka u tnaqqis fl-LVEF kien bejn xahrejn u 5 xhur.
English: • have any liver problems.
Maltese: • għandek jew qatt kellek problemi fil-kliewi.
English: • widespread rash, fever, and enlarged lymph nodes (DRESS-syndrome or drug hypersensitivity syndrome).
Maltese: • raxx mifrux, deni, u glandoli limfatiċi minfuħin (sindrome ta' DRESS jew sindrome ta' sensittività eċċessiva għall-mediċina). ieqaf uża l-mediċina u fittex parir mediku minnufih
English: OUTER CARTON
Maltese: Kollass kardijaku
English: Use with dabrafenib may render hormonal contraceptives less effective and therefore an alternative method of contraception, such as a barrier method, should be used when trametinib is used in combination with dabrafenib.
Maltese: L-użu ma' dabrafenib jista' jrendi l-kontraċettivi ormonjali f'inqas effettivi u, għalhekk, għandu jintuża metodu alternattiv ta' kontraċezzjoni, bħal metodi ta' barriera, meta trametinib jintuża flimkien ma' dabrafenib.
English: Trametinib should be used with caution in patients with moderate or severe hepatic impairment (see sections 4.2 and 4.4).
Maltese: Trametinib għandu jintuża b'kawtela f'pazjenti b'indeboliment epatiku moderat jew sever (ara sezzjonijiet 4.2 u 4.4).
English: Film-coated tablet
Maltese: Fissuri fil-ġilda Fotosensittività
English: • Stomach ache
Maltese: • Vista mċajpra
English: The management of adverse reactions may require dose reduction, treatment interruption or treatment discontinuation (see Tables 1 and 2).
Maltese: Il-ġestjoni ta' reazzjonijiet avversi tista' tkun teħtieġ tnaqqis tad-doża, interruzzjoni tal-kura jew twaqqif tal-kura (ara Tabella 1 u t-Tabella 2).
English: Interstitial lung disease
Maltese: Interazzjonijiet tal-prodott mediċinali
English: • Decreased appetite
Maltese: • nuqqas ta' aptit
English: Mekinist 0.5 mg film-coated tablets trametinib
Maltese: Mekinist 0.5 mg pilloli miksijin b'rita trametinib
English: The efficacy and safety of trametinib in patients with BRAF unresectable or metastatic mutant melanoma (V600E and V600K) were evaluated in a randomised open-label Phase III study (MEK114267 [METRIC]).
Maltese: L-effikaċja u s-sigurtà ta' trametinib f'pazjenti b'melanoma mutanti tal-BRAF (V600E u V600K) li ma tistax titneħħa b'intervent kirurġiku jew metastatika ġew evalwati fi studju open label randomizzat ta' Fażi
English: Hazard ratio is obtained from the stratified Pike model.
Maltese: Il-proporzjon ta' periklu jinkiseb mill-istratifikazzjoni tal-mudell Pike.
English: Dyspnoea
Maltese: Deidratazzjoni
English: Colitis and gastrointestinal perforation, including fatal outcome, have been reported in patients taking trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Maltese: Kienu rrappurtati kolite u perforazzjoni gastrointestinali, uħud minnhom saħansitra fatali, f'pazjenti li jieħdu trametinib bħala monoterapija u flimkien ma' dabrafenib (ara sezzjoni 4.8).
English: Of the patients with confirmed disease progression in the chemotherapy arm, a total of 51 (47%) crossed over to receive trametinib.
Maltese: Mill-pazjenti bi progressjoni tal-marda ikkonfermata fil-fergħa tal-kimoterapija, total ta' 51 (47%) ittrasferew ruħhom biex jirċievu trametinib.
English: Hyperkeratosis
Maltese: Artralġja
English: In the ITT population, 54% of patients were male and all were Caucasian.
Maltese: Fil-popolazzjoni ITT, 54% tal-pazjenti kienu rġiel u kollha kienu Kawkażjatiċi.
English: Signs or symptoms of rhabdomyolysis should warrant an appropriate clinical evaluation and treatment as indicated (see section 4.4).
Maltese: Sinjali jew sintomi ta' rabdomijolożi għandhom jiggarantixxu evalwazzjoni u kura klinika xierqa kif indikat (ara sezzjoni 4.4).
English: Overall response rate, % (95% CI)
Maltese: Rata gloabli ta' rispons, % (95% CI)
English: Infections and infestation Common
Maltese: Infezzjoni u infestazzjonijiet Komuni
English: In rats, hypertrophy of the physis and increased bone turnover were observed, but the physeal hypertrophy is not expected to be clinically relevant for adult humans.
Maltese: Fil-firien, ġew osservati ipertrofija talfiżis u tibdil miżjud ta' għadam, iżda l-ipertrofija fiżjali mhijiex mistennija li tkun klinikament rilevanti għall-bniedem adulti.
English: Median months OS (95% CI)
Maltese: Xhur medjani OS (95% CI)
English: Total dose recovery was low after a 10-day collection period (<50%) following administration of a single oral dose of radiolabelled trametinib as a solution, due to the long elimination half-life.
Maltese: L-irkupru totali tad-doża kien baxx wara perjodu ta' 10 ijiem ta' ġbir (< 50%) wara l-għoti ta' doża waħda orali ta' trametinib radjutikkettat bħala soluzzjoni, minħabba l-half-life twila ta' eliminazzjoni.
English: The majority of subjects had BRAF V600E mutation-positive melanoma (89%).
Maltese: Il-maġġoranza tal-individwi kellhom melanoma pożittiva għal mutazzjoni BRAF V600E (89%).
English: th
Maltese: oC.