FrancophonIA/ELRC3.0 huggingface dataset:
English: In the integrated safety population of trametinib in combination with dabrafenib (n=1,076) 265 patients (25%) were ≥65 years of age; 62 patients (6%) were ≥75 years of age.
Maltese: Fil-popolazzjoni ta' sigurtà integrata ta' trametinib flimkien ma' dabrafenib (n=1,076) 265 pazjent (25%) kellhom età ta' ≥ 65 sena; 62 pazjent (6%) kellhom età ta' ≥ 75 sena.
English: For the primary endpoint of investigator-assessed ORR, the ORR in the first-line population was 61.1% (95% CI, 43.5%, 76.9%) and in the previously-treated population was 66.7% (95% CI, 52.9%, 78.6%).
Maltese: Għall-endpoint primarju tal-ORR ivvalutat mill-investigatur, l-ORR fil-popolazzjoni tal-ewwel linja kien ta' 61.1% (95% CI, 43.5%, 76.9%) u fil-popolazzjoni kkurata qabel kien ta' 66.7% (95% CI, 52.9%, 78.6%).
English: Grade 2-3 RPED that improves to Grade 0-1 within 3 weeks
Maltese: RPED ta' Grad 2-3 li jitjieb għal grad 0-1 fi żmien 3 ġimgħat
English: For October 2011, 47% of subjects had crossed over, while for May 2013, 65% of subjects had crossed over.
Maltese: Għal Ottubru 2011, 47% tal-individwi ġew trasferiti, filwaqt li għal Mejju 2013, 65% tal-individwi ġew trasferiti.
English: Table 13 Investigator-assessed RFS results for Study BRF115532 (COMBI-AD)
Maltese: Tabella 13 Riżultati tal-RFS evalwati mill-investigatur għall-Istudju BRF115532 (COMBI-AD)
English: Steady state was achieved by Day 15.
Maltese: Sa Jum 15 inkiseb stat fiss.
English: In studies MEK115306 and MEK116513 <1% (2/209) and 1 % (4/350), respectively, of patients treated with trametinib in combination with dabrafenib developed pneumonitis or ILD (see section 4.8).
Maltese: Fl-istudji MEK115306 u MEK116513, < 1% (2/209) u 1% (4/350), rispettivament, tal-pazjenti kkurati bi trametinib flimkien ma' dabrafenib żviluppaw pulmonite jew ILD (ara sezzjoni 4.8).
English: May 20,
Maltese: 20 ta' Mejju
English: % (95% CI) ORR difference (95% CI)
Maltese: % (95% CI) Differenza talORR (95% CI)
English: CYP3A4 oxidation is considered a minor pathway of metabolism.
Maltese: Ossidazzjoni ta' CYP3A4 huwa kkunsidrat passaġġ minuri tal-metaboliżmu.
English: The primary endpoint was ORR using the RECIST 1.1 assessed by the investigator.
Maltese: L-endpoint primarju kien l-ORR permezz ta' RECIST 1.1 ivvalutati mill-investigatur.
English: Tablet: mannitol (E421), microcrystalline cellulose (E460), hypromellose (E464), croscarmellose sodium (E468), magnesium stearate (E470b), sodium laurilsulfate and colloidal silicon dioxide (E551).
Maltese: Pillola: mannitol (E421), Microcrystalline cellulose (E460), hypromellose (E464), Croscarmellose sodium (E468), Magnesium stearate (E470b), Sodium laurilsulfate u colloidal silicon dioxide (E551).
English: Folliculitis Paronychia Cellulitis Rash pustular
Maltese: Follikulite Paronikja Ċellulite Raxx pustulari
English: Based on the population pharmacokinetic analysis (range 19 to 92 years), age had no relevant clinical effect on trametinib pharmacokinetics.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni (medda 19-92 sena), l-età ma kellha ebda effett kliniku rilevanti fuq il-farmakokinetika ta' trametinib.
English: The mean absolute bioavailability of a single 2 mg tablet dose is 72% relative to an intravenous (IV) microdose.
Maltese: Il-bijodisponibilità assoluta medja ta' doża ta' pillola waħda ta' 2 mg hija 72% meta mqabbla ma' mikrodoża ġol-vini (IV).
English: Disorders associated with visual disturbances, including RPED and RVO, have been observed with trametinib.
Maltese: Disturbi assoċjati ma' disturbi fil-vista, inkluż RPED u RVO, ġew osservati ma' trametinib.
English: Figure 3 Kaplan-Meier curves of overall survival (OS -ad hoc analysis 20 May 2013)
Maltese: Kaplan-Meier ta' sopravivenza globali (OS analiżi ad-hoc 20 ta' Mejju, 2013)
English: Cardiac failure
Maltese: Disturbi kardijaci
English: Mean terminal half-life is 127 hours (5.3 days) after single dose administration.
Maltese: Il-half-life terminali hija ta' 127 siegħa (5.3 ijiem) wara għoti ta' doża waħda.
English: Mekinist 2 mg tablets trametinib
Maltese: Mekinist 2 mg pilloli trametinib
English: Table 14 Summary of efficacy in the combination treatment cohorts based on investigator and independent radiology review
Maltese: Tabella 14 Sommarju tal-effikaċja fil-gruppi ta' kura ta' kombinazzjoni bbażat fuq reviżjoni tar-radjoloġija tal-investigatur u dik indipendenti
English: The investigator-assessed confirmed response rate was 15% (95% CI: 4.4, 34.9) and the median PFS was 3.6 months (95% CI: 1.9, 5.2).
Maltese: Ir-rata tarrispons ikkonfermata vvalutata mill-investigatur kienet ta' 15% (95% CI: 4.4, 34.9) u l-PFS medja kienet ta' 3.6 xhur (95% CI: 1.9, 5.2).
English: Following administration of 2 mg once daily, steady-state geometric mean Cmax, AUC(0-) and predose concentration were 22.2 ng/ml, 370 ng*hr/ml and 12.1 ng/ml, respectively with a low peak:trough ratio (1.8).
Maltese: Wara l-għoti ta' 2 mg darba kuljum, is-Cmax medju ġeometriku ta' stat stabbli, l-AUC(0-) u l-konċentrazzjoni qabel id-doża kienu 22.2 ng/ml, 370 ng*siegħa/mL u 12.1 ng/ml, rispettivament bi proporzjon massimu:minimu baxx (1.8).
English: Primary tumour or tumour from a metastatic site was tested with a validated polymerase chain reaction (PCR) assay developed by Response Genetics Inc.
Maltese: Tumur primarju jew tumur minn sit metastatiku kien ittestjat permezz ta' prova ta' reazzjoni katina ta' polymerase (PCR) ivvalidat, żviluppat minn Response Genetics Inc.
English: Uncommon ≥1/1,000 to <1/100 Rare
Maltese: ≥ 1/1,000 sa < 1/100
English: The proportion of subjects experiencing adverse reactions (AR) and serious adverse reactions (SAR) was similar in the subjects aged <65 years and those aged ≥65 years.
Maltese: Il-proporzjon ta' individwi li kellhom reazzjonijiet avversi (AR) u reazzjonijiet avversi serji (SAR) kien simili flindividwi ta' età < 65 sena u dawk ta' età ≥ 65 sena.
English: Trametinib was phototoxic in an in vitro mouse fibroblast 3T3 Neutral Red Uptake (NRU) assay at significantly higher concentrations than clinical exposures (IC50 at 2.92 µg/ml, ≥130 times the clinical exposure based on Cmax), indicating that there is low risk for phototoxicity to patients taking trametinib.
Maltese: Trametinib kien fototossiku fi prova in vitro tat-Teħid Aħmar Newtrali (NRU) tal-fibroblast 3T3 filġrieden f'konċentrazzjonijiet ferm ogħla mill-esponimenti kliniċi (IC50 at 2.92 g/mL, ≥ 130 darba lesponiment kliniku ibbażat fuq Cmax), li jindika li hemm riskju baxx għal fototossiċità f'pazjenti li ħadu trametinib.
English: Mekinist 0.5 mg tablets trametinib
Maltese: Mekinist 0.5 mg pilloli trametinib
English: Figure 2 Kaplan-Meier curves Updated OS analysis for Study MEK116513
Maltese: 2 Il-kurvaturi Kaplan-Meier Analiżi aġġornata għall-Istudju MEK116513
English: Chemotherapy included patients on dacarbazine (DTIC) 1000 mg/m2 every 3 weeks or paclitaxel 175 mg/m every 3 weeks.
Maltese: Kimoterapija inkludiet pazjenti fuq dacarbazine (DTIC) 1000 mg/m kull 3 ġimgħat jew paclitaxel 175 mg/m2 kull 3 ġimgħat.
English: Other medicines and Mekinist
Maltese: Mediċini oħra u Mekinist
English: Dabrafenib is an inhibitor of RAF kinases.
Maltese: Dabrafenib huwa inibitur ta' kinase RAF.
English: Most patients (87%) in the ITT population had BRAF V600E mutation and 12% of patients had BRAF V600K.
Maltese: Ħafna mill-pazjenti (87%) fil-popolazzjoni ITT kellhom mutazzjoni BRAF V600E u 12% tal-pazjenti kellhom BRAF V600K.
English: The increase in exposure (Cmax and AUC) was dose-proportional following repeat dosing.
Maltese: Iż-żieda fl-espożizzjoni (Cmax u AUC) kienet proporzjonali għad-doża wara doża ripetuta.
English: Mekinist is a medicine that contains the active substance trametinib.
Maltese: Mekinist hija mediċina li fiha s-sustanza attiva trametinib.
English: Effect of other medicinal products on trametinib
Maltese: Effett ta' prodotti mediċinali oħra fuq trametinib
English: Cut-off dates
Maltese: Dati tallimitu
English: The risk of haemorrhage may be increased with concomitant use of antiplatelet or anticoagulant therapy.
Maltese: Ir-riskju ta' emorraġija jista' jiżdied bl-użu konkomitanti ta' terapija antiplejtlits jew antikoagulanti.
English: The combination of trametinib with dabrafenib has shown anti-tumour activity in BRAF V600 mutation positive melanoma cell lines in vitro and delays the emergence of resistance in vivo in BRAF V600 mutation positive melanoma xenografts.
Maltese: Il-kombinazzjoni ta' trametinib ma' dabrafenib uriet attività anti-tumur f'linji ta' ċelloli tal-melanoma pożittiva għall-mutazzjoni BRAF V600 in vitro u ddewwem lemerġenza tar-reżistenza in vivo f'xenografts tal-melanoma pożittiva għall-mutazzjoni BRAF V600.
English: Table 3 Recommended dose modifications for trametinib for RPED
Maltese: Tabella 3 Modifiki fid-doża rrakkomandati għal trametinib għal RPED
English: The most common adverse reactions (incidence ≥20%) for trametinib were rash, diarrhoea, fatigue, oedema peripheral, nausea, and dermatitis acneiform.
Maltese: L-aktar reazzjonijiet avversi komuni (inċidenza ta' ≥ 20%) għal trametinib kienu raxx, dijarea, għeja, edema periferali, dardir, u dermatite akneiforma.
English: Median PFS (months) (95% CI) Hazard Ratio (95% CI) P value Overall Response Rate (%)
Maltese: PFS medjana (xhur) (95% CI) Proporzjon tal-Periklu (95% CI) Valur p Ir-Rata Globali tar-Rispons (%)
English: Administration of a single dose of trametinib with a high-fat, high-calorie meal resulted in a 70% and 10% decrease in Cmax and AUC, respectively compared to fasted conditions (see sections 4.2 and 4.5).
Maltese: Għoti ta' doża waħda ta' trametinib ma' ikla b'ħafna kaloriji u b'ħafna xaħam irriżulta fi tnaqqis ta' 70% u 10% fis-Cmax u fl-AUC, rispettivament meta mqabbla mal-kundizzjonijiet ta' sawm (ara sezzjonijiet 4.2 u 4.5) .
English: Yellow, modified oval, biconvex, film-coated tablets, approximately 4.8 x 8.9 mm, with “GS” debossed on one face and “TFC” on the opposing face.
Maltese: Pilloli miksijin b'rita, bikonvessi, ovali modifikati, sofor ta' madwar 4.8 x 8.9 mm, b'‘GS' imnaqqxa fuq wiċċ wieħed u ‘TFC' fuq in-naħa l-oħra.
English: Most subjects had LDH ≤ULN (65%), Eastern Cooperative Oncology Group (ECOG) performance status of 0 (72%), and visceral disease (73%) at baseline.
Maltese: Il-biċċa l-kbira tal-individwi kellhom LDH ≤ ULN (65%), status talprestazzjoni tal-Grupp tal-Koperazzjoni tal-Onkoloġija tal-Lvant (ECOG - Eastern Cooperative Oncology Group) ta' 0 (72%) u marda vixxerali (73%) fil-linja bażi.
English: Renal and urinary disorders Uncommon
Maltese: Disturbi renali u urinarji
English: Dermatitis acneiform Actinic keratosis
Maltese: Dermatite esfoljattiva ġeneralizzata
English: In an embryo-foetal developmental toxicity study with rabbits, decreased foetal body weight, increased abortions, increased incidence of incomplete ossification and skeletal malformations were seen at sub-clinical exposures based on AUC).
Maltese: Fi studju ta' tossiċità tal-iżvilupp embrijofetali, tnaqqis fil-piż tal-ġisem tal-fetu, żieda fl-aborti, inċidenza akbar ta' ossifikazzjoni mhux kompleta u malformazzjonijiet skeletriċi dehru f'esponimenti sottokliniċi bbażati fuq l-AUC).
English: OS analysis (data cut-off: 12-Jan-2015)
Maltese: Analiżi aġġornata (data tallimitu: 12-Jan-2015)
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 study
English: The safety of trametinib monotherapy has been evaluated in the integrated safety population of 329 patients with BRAF V600 mutant unresectable or metastatic melanoma treated with trametinib 2 mg once daily in studies MEK114267, MEK113583, and MEK111054.
Maltese: Is-sigurtà ta' monoterapija bi trametinib ġiet evalwata fil-popolazzjoni ta' sigurtà integrata ta' 329 pazjenti b'melanoma li jew għandha mutazzjoni BRAF V600 u ma titneħħiex b'intervent krurġiku jew li hija metastatika ikkurata bi trametinib 2 mg darba kuljum fl-istudji MEK114267, MEK113583, u MEK111054.
English: Based on updated data with an additional 10 months of follow-up compared to the primary analysis (minimum follow-up of 40 months), the RFS benefit was maintained with an estimated HR of 0.49 [95% CI: (0.40, 0.59)] (Figure 4).
Maltese: Abbażi ta' dejta aġġornata b'10 xhur addizzjonali ta' segwitu meta mqabbla mal-analiżi primarja (segwitu minimu sa 40 xahar), il-benefiċċju RFS inżamm b'HR stmat ta' 0.49 [95 % CI: (0.40, 0.59)] (Figura 4).
English: Hypertension Haemorrhage b
Maltese: Pressjoni għolja Emorraġija b
English: Mekinist can result in the breakdown of muscle (rhabdomyolysis).
Maltese: Mekinist jista' jirriżulta fit-tkissir tal-muskolu (rabdomijolosi).
English: The response was durable with median DoR in the previously-treated population reaching 9.8 months (95% CI, 6.9, 16.0) by investigator assessment.
Maltese: Irrispons kien durabbli bid-DoR medjan fil-popolazzjoni kkurata qabel jilħaq id-9.8 xhur (95% CI, 6.9, 16.0) fil--valutazzjoni tal-investigatur.
English: Permanently discontinue trametinib.
Maltese: Waqqaf trametinib b'mod permanenti.
English: 7.5d 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 dabrafenib+trametinib and 42% of vemurafenib) of investigator-assessed responses were still ongoing
Maltese: d 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% ta' dabrafenib+trametinib u 42% ta' vemurafenib) tarreazzjonijiet ivvalutati mill-investigatur kienu għadhom għaddejjin NR = Ma ntlaħaqx
English: Film coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol, iron oxide yellow (E172) (for 0.5 mg tablets), polysorbate 80 (E433) and iron oxide red (E172) (for 2 mg tablets).
Maltese: Il-kisja tar-rita: hypromellose (E464), Titanium dioxide (E171), Polyethylene glycol, Iron oxide yellow (E172) (għal 0.5 mg pilloli), polysorbate 80 (E433) u Iron oxide red (E172) (għal 2 mg pilloli).
English: The pharmacokinetics of trametinib were characterised in 223 patients enrolled in clinical trials with trametinib who had mild renal impairment and 35 patients with moderate renal impairment using a population pharmacokinetic analysis.
Maltese: Il-farmakokinetika ta' trametinib kienet ikkaratterizzata f'223 pazjent irreġistrati fi provi kliniċi b'trametinib li kellhom indeboliment renali ħafif u 35 pazjent b'indeboliment renali moderat permezz ta' analiżi farmakokinetika tal-popolazzjoni.
English: Trametinib has a volume of distribution of approximately 1200 L determined following administration of a 5 g intravenous microdose.
Maltese: Trametinib għandu volum ta' distribuzzjoni ta' madwar 1200 L determinat wara l-għoti ta' 5 g mikrodoża ġol-vini.
English: In the first-line population, 68% of patients had not progressed after 9 months.
Maltese: Fil-popolazzjoni tal-ewwel linja, 68% tal-pazjenti ma wrew lebda progressjoni fil-marda wara 9 xhur.
English: 75 mg twice daily
Maltese: 75 mg darbtejn kuljum
English: Trametinib suppressed levels of phosphorylated ERK in BRAF mutant melanoma tumour cell lines and melanoma xenograft models.
Maltese: Trametinib rażżan livelli ta' ERK fosforilat f'riti taċ-ċelluli tat-tumur tal-melanoma b'mutazzjoni BRAF u mudelli ta' xenograft tal-melanoma.
English: The 5-year overall survival rate was 46% (95% CI: 38.8, 52.0) in the combination arm versus 28% (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: Based on in vitro and in vivo data, trametinib is unlikely to significantly affect the pharmacokinetics of other medicinal products via interaction with CYP enzymes or transporters (see section 5.2).
Maltese: Ibbażat fuq dejta in vitro u in vivo, trametinib probabbilment jaffettwa b'mod sinifikanti lfarmakokinetika ta' prodotti mediċinali oħra permezz ta' interazzjoni ma' enzimi CYP jew trasportaturi (ara sezzjoni 5.2).
English: Rash has been observed in about 60% of patients when given as monotherapy and in about 24% of patients in trametinib and dabrafenib combination studies in the integrated safety population.
Maltese: Ġie osservat raxx f'madwar 60% tal-pazjenti mogħtija monoterapija u f'madwar 24% tal-pazjenti flistudji ta' kombinazzjoni ta' trametinib u dabrafenib fl-popolazzjoni ta' sigurtà integrata.
English: EU/1/14/931/005 7 film-coated tablets EU/1/14/931/006 30 film-coated tablets
Maltese: EU/1/14/931/005 7 pilloli miksijin b'rita EU/1/14/931/006 30 pillola miksijin b'ritaz
English: Gastrointestinal perforation Colitis
Maltese: Perforazzjoni gastrointestinali Kolite
English: Trametinib is an in vitro substrate of the efflux transporter P-gp.
Maltese: Trametinib huwa substrat in vitro ta' BSEP u t-trasportatur ta' effluss P-gp.
English: Table 5 Adverse reactions reported in the integrated safety population of trametinib in combination with dabrafenib in the studies MEK115306, MEK116513
Maltese: Reazzjonijiet avversi rrapportati fil-popolazzjoni ta' sigurtà integrata ta' trametinib flimkien ma' dabrafenib fl-istudji MEK115306, MEK116513
English: Most subjects had LDH ≤ULN (67%), ECOG performance status of 0 (70%), and visceral disease (78%) at baseline.
Maltese: Il-biċċa l-kbira tal-individwi kellhom LDH ≤ ULN (67%), status tal-prestazzjoni ECOG ta' 0 (70%) u marda vixxerali (78%) fil-linja bażi.
English: Symptoms such as blurred vision, decreased acuity, and other visual disturbances have been reported in the clinical trials with trametinib (see sections 4.2 and 4.4).
Maltese: Sintomi bħal vista mċajpra, tnaqqis fl-akutezza, u disturbi viżivi oħrajn ġew irrappurtati fil-provi kliniċi bi trametinib (ara sezzjonijiet 4.2 u 4.4).
English: Mekinist 0.5 mg film-coated tablets EU/1/14/931/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Mekinist 0.5 mg pilloli miksijin b'rita EU/1/14/931/001
English: As trametinib is metabolised predominantly via deacetylation mediated by hydrolytic enzymes (e.g. carboxyl-esterases), its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions (see section 5.2).
Maltese: Minħabba li trametinib huwa metabolizzat primarjament permezz ta' deaċetilazzjoni medjata minn enzimi idrolitiċi (eż. carboxyl-esterases), il-farmakokinetika tiegħu x'aktarx li tiġi affettwata minn sustanzi oħrajn permezz ta' interazzjonijiet metaboliċi (ara sezzjoni 5.2).
English: Severe cutaneous adverse reactions
Maltese: Reazzjonijiet avversi gravi tal-ġilda
English: The majority of subjects had a BRAF V600E mutation (85%).
Maltese: Il-maġġoranza tal-individwi kellhom mutazzjoni BRAF V600E (85%).
English: May present with symptoms such as fever, rash, increased liver transaminases, and visual disturbances b Events include but are not limited to: epistaxis, haematochezia, gingival bleeding, haematuria, and rectal, haemorrhoidal, gastric, vaginal, conjunctival, intracranial and post-procedural haemorrhage.
Maltese: Tista' tippreżenta ruħha b'sintomi bħal deni, raxx, żieda fit-tranżaminażi tal-fwied, u disturbi fil-vista a Avvenimenti jinkludu iżda mhumiex limitati għal: epistassi, haematochezia, ħruġ ta' demm mill-ħanek, ematurja, u emorraġija tar-rektum, mal-murliti, gastrika, vaġinali, konġunktivali, intrakranjali u emorraġija postproċedurali.
English: Frequency (all grades)
Maltese: Frekwenza (il-gradi kollha)
English: Symptoms such as blurred vision, decreased acuity, and other visual phenomena have been reported in the clinical trials with trametinib (see section 4.8).
Maltese: Sintomi bħal vista mċajpra, tnaqqis fl-akutezza u fenomeni viżivi oħrajn ġew irrappurtati fil-provi kliniċi b'trametinib (ara sezzjoni 4.8).
English: 5-year OS analysis (data cut-off: 08-Oct-2018)
Maltese: Analiżi fuq 5 snin (Data tallimitu: 08-Ott-2018)
English: Patients with LVEF lower than the institutional lower limit of normal were not included in clinical trials with trametinib.
Maltese: Il-pazjenti b'LVEF taħt il-limitu minimu tal-istituzzjoni tan-normal ma ġewx inklużi fil-provi kliniċi bi trametinib.
English: Patients ≥65 years were more likely to experience SARs and ARs leading to permanent discontinuation of medicinal product, dose reduction and dose interruption than those <65 years.
Maltese: Pazjenti ≥ 65 sena kienu aktar probabbli li jkollhom ARs li jwasslu għat-twaqqif permanenti tal-prodott mediċinali, tnaqqis fid-doża u interruzzjoni tad-doża minn dawk < 65 sena.
English: oC please refer to the dabrafenib SmPC (section 4.2) for dose modifications for dabrafenib.
Maltese: oC, jekk jogħġbok irreferi għall-SmPC ta' dabrafenib (sezzjoni 4.2) għall-modifiki fid-doża għal dabrafenib.
English: Primary analysis (data cutoff: 26-Aug-2013)
Maltese: Analiżi primarja (data tallimitu: 26-Aww-2013)
English: The safety of trametinib in combination with dabrafenib has been evaluated in the integrated safety population of 1,076 patients with BRAF V600 mutant unresectable or metastatic melanoma, Stage III BRAF V600 mutant melanoma following complete resection (adjuvant treatment) and advanced NSCLC treated with trametinib 2 mg once daily and dabrafenib 150 mg twice daily.
Maltese: Is-sigurtà ta' trametinib flimkien ma' dabrafenib ġiet evalwatafil-popolazzjoni ta' sigurtà integrata ta' 1,076 pazjent b'melanoma li jew għandha mutazzjoni BRAF V600 u ma titneħħiex b'intervent krurġiku jew li hija metastatika, melanoma fi Stadju III b'mutazzjoni BRAF V600 wara tneħħija sħiħa b'intervent kirurġiku (trattament adjuvanti) u NSCLC avvanzat ikkurati b'trametinib 2 mg darba kuljum u dabrafenib 150 mg darbtejn kuljum.
English: EU/1/14/931/001 7 film-coated tablets EU/1/14/931/002 30 film-coated tablets
Maltese: EU/1/14/931/001 7 pilloli miksijin b'rita EU/1/14/931/002 30 pillola miksijin b'rita
English: Chorioretinopathy Papilloedema Retinal detachment Retinal vein occlusion
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The Mekinist 0.5 mg film-coated tablets are yellow, modified oval, biconvex, with “GS” debossed on one face and “TFC” on the opposing face.
Maltese: Mekinist 0.5 mg pilloli miksijin b'rita huma sofor ovali modifikati, bikonvessi, b''GS' imnaqqxa fuq wiċċ wieħed u ‘TFC' fuq in-naħa l-oħra.
English: Tablet film coating Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Iron oxide yellow(E172)
Maltese: Kisja tal-pillola b'rita Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Iron oxide yellow (E172)
English: As it cannot be excluded that strong inhibition of hepatic P-gp may result in increased levels of trametinib, caution is advised when co-administering trametinib with medicinal products that are strong inhibitors of P-gp (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole).
Maltese: Trametinib huwa substrat in vitro tat-trasportatur tal-effluss P-gp. Minħabba li ma jistax jiġi eskluż li inibizzjoni qawwija ta' P-gp epatika tista' tirriżulta f'żieda fil-livelli ta' trametinib, huwa rrakkomandat li tingħata attenzjoni meta trametinib jingħata flimkien ma' prodotti mediċinali li huma inibituri qawwija ta' P-gp (eż. verapamil, cyclosporine, ritonavir, quinidine, itraconazole).