FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Phase III dose-optimisation study in advanced phase CML and Ph+ALL, grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% to 5% of patients across treatment groups.
Maltese: III dwar l-ottimizzazzjoni tad-doża fil-fażi avvanzata ta' CML u Ph+ ALL ġew irrappurtati żidiet ta' grad 3 jew 4 fittransaminases jew bilirubina f'minn 1 % sa 5 % ta' pazjenti li kienu fil-gruppi tal-kura.
English: Step 1: Tap bottom of each bottle (containing 33 g SPRYCEL powder for oral suspension) gently to loosen the powder.
Maltese: Pass 1: Taptap il-qiegħ ta' kull flixkun (li fih 33 g SPRYCEL trab għal sospensjoni orali) bil-mod biex terħi t-trab.
English: Myeloid blast phase CML
Maltese: Mhux magħrufa riattivazzjoni tal-epatite B
English: CHR (chronic CML): WBC ≤ institutional ULN, platelets < 450,000/mm3, no blasts or promyelocytes in peripheral blood, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Maltese: Ċelloli tad-demm bojod (WBC) ≤ ULN istituzzjonali, plejtlits < 450,000/mm3, ebda blasts jew promajeloċiti f'demm periferali, < 5 % majeloċiti miżjud b'metamajeloċiti fid-demm periferali, < 20 % bażofili fiddemm periferali, u ebda involviment ekstramedullari.
English: Discontinuation within 60 months due to disease progression occurred in 11% of SPRYCEL-treated patients and 14% of imatinib-treated patients.
Maltese: Il-waqfien fi żmien 60 xahar minħabba l-progressjoni tal-marda seħħ fi 11 % talpazjenti kkurati bi SPRYCEL u f'14 % tal-pazjenti kkurati b'imatinib.
English: Rare leukocytoclastic vasculitis, skin fibrosis
Maltese: Rari aplasija pura taċ-ċelluli ħomor Disturbi fis-sistema immuni
English: The use of antacids should be considered in place of H2 antagonists or proton pump inhibitors in patients receiving SPRYCEL therapy (see section 4.4).
Maltese: L-użu ta' antaċidi għandu jkun ikkunsidrat minflok antagonisti tar-riċetturi H2 jew inibituri tal-proton pump f'pazjenti li qed jirċievu terapija bi SPRYCEL (ara sezzjoni 4.4).
English: In the Phase III study in patients with newly diagnosed chronic phase CML, one patient (< 1%) of the SPRYCEL-treated patients had a QTcF > 500 msec after a minimum of 12 months follow-up (see section 4.4).
Maltese: III fuq pazjenti ddijanjostikati għall-ewwel darba b'CML fil-fażi kronika, pazjent wieħed (< 1 %) mill-pazjenti kkurati bi SPRYCEL, kellu QTcF ta' > 500 msek wara minimu ta' 12-il xahar ta' follow-up (ara sezzjoni 4.4).
English: An open-label, single-arm, multicentre study was conducted in patients resistant or intolerant to imatinib (i.e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment).
Maltese: Sar studju open-label, b'fergħa waħda, f'ċentri varji fuq pazjenti reżistenti jew intolleranti għal imatinib (jiġifieri pazjenti li sofrew tossiċità sinifikanti waqt it-trattament b'imatinib tant li twaqqfilhom t-trattament).
English: Daily Dose (mg)
Maltese: Doża ta' Kuljum (mg)
English: Uncommon pancreatitis (including acute pancreatitis), upper gastrointestinal ulcer, oesophagitis, ascites*, anal fissure, dysphagia, gastroesophageal reflux disease
Maltese: It-testijiet jistgħu juru: fluwidu madwar il-qalb, fluwidu fil-pulmun, arritmja, newtropenja bid-deni, fsada gastrointestinali, livelli għoljin ta' aċidu uriku fid-demm
English: Instructions for constitution of powder for oral suspension
Maltese: Istruzzjonijiet għall-kostituzzjoni ta' trab għal sospensjoni orali
English: Patients aged 65 years and older are more likely than younger patients to experience pleural effusion, dyspnoea, cough, pericardial effusion and congestive heart failure, and should be monitored closely.
Maltese: Pazjenti ta' 65 sena u akbar huma aktar probabbli minn pazjenti iżgħar li jesperjenzaw effużjoni plewrali, dispnea, sogħla, effużjoni perikardijaka u insuffiċjenza konġestiva tal-qalb, u għandhom jiġu mmonitorjati mill-qrib.
English: Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Maltese: Kun ċert li taqra u tifhem dawn listruzzjonijiet qabel tuża s-sospensjoni orali.
English: Improvements in haemodynamic and clinical parameters have been observed in dasatinib-treated patients with PAH following cessation of dasatinib therapy.
Maltese: Ir-riżultati deskritti hawn taħt huma bbażati fuq minimu ta' sentejn u 7 snin ta' follow-up wara l-bidu tat-terapija b'dasatinib.
English: Median duration of treatment was 23 months for dasatinib (with 44% of patients treated for > 24 months to date) and 3 months for imatinib (with 10% of patients treated for > 24 months to date).
Maltese: It-tul medju tat-trattament kien ta' 23 xahar għal dasatinib (b'44 % tal-pazjenti ttrattati għal > 24 xahar sa llum) u 3 xhur għal imatinib (b'10 % tal-pazjenti ttrattati għal > 24 xahar sa llum).
English: Lymphoid toxicity in rats consisted of lymphoid depletion of the lymph nodes, spleen, and thymus, and decreased lymphoid organ weights.
Maltese: It-tossiċità tallimfojde fil-firien kienet tikkonsisti minn tnaqqis tal-limfojde tal-lymph nodes, tal-milsa, u tat-timu, u tnaqqis fil-piżijiet ta' l-organi tal-limfojde.
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 80 mg tablets dasatinib
Maltese: SPRYCEL 80 mg pilloli miksija b'rita dasatinib
English: Reproductive system and breast disorders Uncommon gynecomastia, menstrual disorder General disorders and administration site conditions Very common peripheral oedemai, fatigue, pyrexia, face oedemaj
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata Komuni ħafna edima periferalii, għeja kbira, deni, edima fil-wiċċj
English: In addition, there were two studies in a total of 161 paediatric patients with Ph+ ALL in which SPRYCEL was administered in combination with chemotherapy.
Maltese: Barra minn hekk, kien hemm żewġ studji f'total ta' 161 pazjent pedjatriku b'Ph+ ALL li fihom SPRYCELingħata flimkien ma' kimoterapija.
English: Patients who develop dyspnoea and fatigue after initiation of therapy should be evaluated for common etiologies including pleural effusion, pulmonary oedema, anaemia, or lung infiltration.
Maltese: Pazjenti li jiżviluppaw dispnea u għejja wara l-bidu tal-kura għandhom jiġu evalwati għal etjoloġiji komuni inkluż effużjoni plewrali, edema pulmonari, anemija jew infiltrazzjoni tal-pulmun.
English: Median duration of treatment for all patients at 7 years of follow-up was 29.8 months (range < 1-92.9 months).
Maltese: Il-perjodu medju ta' trattament għall-pazjenti kollha wara 7 snin ta' follow-up kien ta' 29.8 xahar (medda < 1-92.9 xahar).
English: SPRYCEL 70 mg film-coated tablets dasatinib
Maltese: SPRYCEL 70 mg pilloli miksija b'rita dasatinib
English: Patients achieving early molecular response had a lower risk of transformation, higher rate of progression-free survival (PFS) and higher rate of overall survival (OS), as shown in Table 10.
Maltese: Pazjenti li kisbu rispons molekulari bikri kellhom riskju aktar baxx ta' trasformazzjoni, rata ogħla ta' sopravivenza mingħajr progressjoni (PFS) u rata ogħla ta' sopravivenza globali (OS), kif muri f'Tabella 10.
English: A total of 611 patients were randomised to either the dasatinib 140 mg once daily or 70 mg twice daily group.
Maltese: Total ta' 611-il pazjent ġew magħżula b'mod każwali għall-grupp ta' dasatinib 140 mg darba kuljum jew għall-grupp ta' dasatinib 70 mg darbtejn kuljum.
English: SPRYCEL is prescribed for adults and children at least 1 year of age.
Maltese: SPRYCEL huwa preskritt għall-adulti u għat-tfal ta' talinqas età ta' sena.
English: Prior imatinib (N = 46)b a Patients from Phase II paediatric study of newly diagnosed CML-CP receiving oral tablet formulation b Patients from Phase I and Phase II paediatric studies of imatinib-resistant or intolerant CML-CP receiving oral tablet formulation
Maltese: Dasatinib kien studjat fi studju kliniku fejn 519-il pazjent iddijanjostikat għall-ewwel darba b'CML fil-fażi kronika ntgħażel b'mod każwali u li kien jinkludi wkoll pazjenti b'mard kardijaku fil-passat.
English: In all SPRYCEL treated patients with chronic phase CML, severe fluid retention occurred in 32 patients (6%) receiving SPRYCEL at the recommended dose (n=548).
Maltese: Fil-pazjenti kollha kkurati bi SPRYCEL li kellhom CML fil-fażi kronika, żamma severa ta' fluwidu seħħet fi 32 pazjent (6 %) li kienu qegħdin jirċievu SPRYCEL fid-doża rakkomandata (n = 548).
English: If SPRYCEL must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to:
Maltese: Jekk SPRYCEL irid jingħata ma' inibitur qawwi ta' CYP3A4, ikkunsidra tnaqqis fid-doża għal:
English: SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 50 mg dasatinib (bħala monoidrat).
English: SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 100 mg dasatinib (bħala monoidrat).
English: Very common headache Common neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence Uncommon CNS bleeding*b, syncope, tremor, amnesia, balance disorder
Maltese: Mhux komuni ħruġ ta' demm fis-SNĊ*b, sinkope, rogħda, amnesija, disturb fil-bilanċ
English: In the pivotal study, 106 paediatric patients received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
Maltese: Fl-istudju pivotali, 106 pazjenti pedjatriċi rċivew SPRYCEL flimkien ma' kemoterapija fuq reġimen ta' dożaġġ kontinwu.
English: Among the 126 Ph+ ALL paediatric patients treated with SPRYCEL on a continuous dosing regimen, the median duration of therapy was 23.6 months (range 1.4 to 33 months).
Maltese: Fost il-126 pazjent pedjatriku b'Ph+ ALL ikkurati bi SPRYCEL fuq reġimen ta' dożaġġ kontinwu, it-tul medjan tatterapija kien ta' 23.6 xhur (medda 1.4 sa 33 xahar).
English: A low-fat meal 30 minutes prior to dasatinib resulted in a 21% increase in the mean AUC of dasatinib.
Maltese: Ikla b'ammont baxx ta' xaħam 30 minuta qabel dasatinib irriżultat f'żieda ta' 21 % fl-AUC medju ta' dasatinib.
English: The median duration of treatment for all patients still on therapy with a minimum of 5 years of follow-up (n=205) was 59 months (range 28-66 months).
Maltese: It-tul ta' żmien medjan tal-kura għall-pazjenti kollha li kienu għadhom fuq it-terapija b'minimu ta' 5 snin ta' follow-up (n = 205) kien ta' 59 xahar (medda 28-66 xahar).
English: In the paediatric ALL studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults, within the context of an acute leukaemia patient receiving a background chemotherapy regimen.
Maltese: Fl-istudji ta' ALL pedjatrika, ir-rati ta' anormalitajiet tal-laboratorju kienu konsistenti mal-profil magħruf għal parametri tal-laboratorju fl-adulti, fil-kuntest ta' pazjent b'lewkimja akuta li rċieva reġimen tal-kimoterapija ta' sfond.
English: White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side.
Maltese: Pillola miksija b'rita tonda, tvarja minn bajda għal offwajt, ibbuzzata fuq iż-żewġ naħat, b'“BMS 140” imnaqqxa fuq naħa waħda u “857” fuq in-naħa l-oħra.
English: EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle)
Maltese: EU/1/06/363/015 - 30 x 1 pillola miksijin b'rita (folji b'doża waħda)
English: Pyrexia
Maltese: MCyR
English: Number of patients (%) Transformation at 60 months, n/N (%) Rate of PFS at 60 months (95% CI) Rate of OS at 60 months (95% CI)
Maltese: Rata ta' PFS wara 60 xahar (95 % CI) Rate ta' OS wara 60 xahar (95 % CI)
English: The cardiac adverse reactions of congestive heart failure/cardiac dysfunction, pericardial effusion, arrhythmias, palpitations, QT prolongation and myocardial infarction (including fatal) were reported in patients taking dasatinib.
Maltese: Ir-reazzjonijiet kardijaċi avversi ta' insuffiċjenza konġestiva tal-qalb/disfunzjoni kardijaka, effużjoni perikardijaka, arritmiji, palpitazzjonijiet, titwil tal-QT u infart mijokardijaku (fosthom fatali), kienu rrappurtati f'pazjenti li kienu qed jieħdu dasatinib.
English: QT interval was corrected for heart rate by Fridericia's method.
Maltese: L-intervall tal-QT kien ikkoreġut għar-rata ta' taħbit ta' qalb bil-metodu Fridericia.
English: The recommended starting daily dosage of SPRYCEL powder for oral suspension for paediatric patients with Ph+ CML-CP or Ph+ ALL and adult patients with Ph+ CML-CP who cannot swallow tablets is shown in Table 1.
Maltese: Id-dożaġġ ta' kuljum tal-bidu rakkomandat ta' SPRYCEL trab għal sospensjoni orali għal pazjenti pedjatriċi b'Ph+ CML-CP jew Ph+ ALL u pazjenti adulti b'Ph+ CML-CP li ma jistgħux jibilgħu pilloli sħaħ jidher f'Tabella 1.
English: 85% of the radioactivity recovered in the urine and faeces, respectively.
Maltese: b'4 % u 85 % tar-radjuattività rkuprata fl-awrina u fl-ippurgar, rispettivament.
English: In vitro, dasatinib is active in leukaemic cell lines representing variants of imatinib-sensitive and resistant disease.
Maltese: In vitro, idasatinib hu attiv f'linji ta' ċelluli bil-lewkimja li jirrappreżentaw varjanti ta' mard sensittiv u reżistenti għal imatinib.
English: Myelosuppression was also reported less frequently in the 100 mg once daily treatment group (see Laboratory test abnormalities below).
Maltese: Il-majelosoppressjoni kienet irrappurta wkoll b'mod inqas frekwenti fil-grupp ta' kura li ħa 100 mg darba kuljum (ara Anormalitajiet tat-testijiet tal-laboratorju hawn taħt).
English: Carriers of HBV who require treatment with SPRYCEL should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Maltese: Portatuti tal-HBV li jeħtieġu l-kura b'SPRYCEL għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi tal-infezzjoni attiva tal-HBV waqt il-kura u għal diversi xhur wara li tintemm il-kura (ara sezzjoni 4.8).
English: Gilbert's syndrome
Maltese: Sindrome ta' Gilbert
English: COMBO 450
Maltese: Combo 450 miġbura).
English: EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets
Maltese: EU/1/18/1315/001 84 pillola miksijin b'rita EU/1/18/1315/002 168 pillola miksijin b'rita
English: PVC/PVDC/Alu blister containing 12 tablets.
Maltese: Folja tal-PVC/PVDC/Alu li fiha 12-il pillola.
English: Number of events (progressive disease(PD)) (%)
Maltese: Numru ta' avvenimenti (marda progressiva PD)) (%)
English: Updated analysis, cut-off date: 07 November 2017
Maltese: Analiżi aġġornata, data tal-cut off: 07 ta' Novembru 2017 PFS
English: In vitro, CYP1A2 and CYP2C19 catalyse the formation of the active metabolite, AR00426032 (M3) by oxidative N-desmethylation.
Maltese: In vitro, CYP1A2 u CYP2C19 jikkatalizzaw il-formazzjoni tal-metabolit attiv, AR00426032 (M3) minn N-desmethylation ossidattiv.
English: - The active substance is binimetinib.
Maltese: - Is-sustanza attiva hi binimetinib.
English: Binimetinib is 97.2 % bound to human plasma proteins in vitro.
Maltese: Binimetinib huwa 97.2 % marbut ma' proteini tal-plażma tal-bniedem in vitro.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES)
Maltese: Sindrome tal-eritrodisasteżija palmari plantari (PPES)
English: Each film-coated tablet contains 133.5 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 133.5 mg ta' lactose monohydrate.
English: Binimetinib has phototoxic potential in vitro.
Maltese: Binimetinib għandu potenzjal fototossiku in vitro.
English: Cut-off date: 19 May 2016
Maltese: Data tal-cut off: 19 ta' Mejju 2016
English: In vitro experiments indicate that binimetinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Maltese: Esperimenti in vitro jindikaw li binimetinib huwa substrat ta' glikoproteina P (P-gp) u proteina ta' reżistenza għall-kanċer tas-sider (BCRP, breast cancer resistance protein).
English: Visual impairment was generally reversible.
Maltese: Vista batuta kienet ġeneralment riversibbli.
English: The median (range) binimetinib terminal half-life (T1/2) was 8.66 h (8.10 to 13.6 h).
Maltese: Il-half-life terminali (T1/2) ta' binimetinib medjana (medda) kienet ta' 8.66 sigħat (8.10 to 13.6 sigħat).
English: • Grade 4 (CK > 10x ULN) asymptomatic
Maltese: • Grad 4 (CK > 10x ULN) asintomatiku
English: • Uncomplicated deep vein thrombosis (DVT) or pulmonary embolism (PE) ≤ Grade 3
Maltese: • Trombożi tal-vini fondi mhux ikkumplikata (DVT, deep vein thrombosis) jew emboliżmu pulmonari (PE, pulmonary embolism) ≤ Grad 3
English: Gastrointestinal disorders were typically managed with standard therapy.
Maltese: Id-disturbi gastro-intestinali ġew tipikament immaniġġjati b'terapija standard.
English: • a medicine used to treat breathing problems, theophylline.
Maltese: • mediċina użata għall-kura ta' problemi fin-nifs, theophylline.
English: • Tablet core: lactose monohydrate, cellulose microcrystalline (E460i), silica colloidal anhydrous (E551), croscarmellose sodium (E468) and magnesium stearate (E470b).
Maltese: • Qalba tal-pillola: lactose monohydrate, cellulose microcrystalline (E460i), silica colloidal anhydrous (E551), croscarmellose sodium (E468) u magnesium stearate (E470b).
English: See section 2 “Mektovi contains lactose”.
Maltese: Ara sezzjoni 2 “Mektovi fih lattożju”.
English: Mektovi 15 mg tablets binimetinib
Maltese: Mektovi 15 mg pilloli binimetinib
English: Each pack contains either 84 or 168 tablets.
Maltese: Kull pakkett fih 84 jew 168 pillola.
English: Haemorrhagic events were observed in 17.9 % (49/274) of patients in the pooled Combo 450 population.
Maltese: L-avvenimenti emorraġiċi ġew osservati fi 17.9 % (49/274) tal-pazjenti fil-popolazzjoni Combo 450 miġbura.
English: • Grade 2 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x - ≤ 5x upper limit of normal (ULN)
Maltese: (AST, aspartate aminotransferase) jew alanina aminotransferażi (ALT, alanine aminotransferase) > 3x - ≤ 5x limitu ogħla tan-normal (ULN)
English: Photosensitivity*
Maltese: Fotosensittività*
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE41
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, inibitur ta' kinażi tal-proteini, Kodiċi ATC:
English: • Increased GGT: 14.6% (40/274) overall - Grade 3-4: 8.4% (23/274)
Maltese: • Żieda fil-GGT: 14.6 % (40/274) globali - Grad 3-4 : 8.4 % (23/274)
English: Quality of Life (QoL) (cut-off date: 19 May 2016)
Maltese: Kwalità tal-Ħajja (QoL, Quality of Life ) (data tal-cut-off: 19 ta' Mejju 2016)
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of interim overall survival (cut-off date: 7 November 2017)
Maltese: Studju CMEK162B2301, Parti 1: Plott Kaplan-Meier ta' sopravivenza globali interim (data tal-cut-off: 7 ta' Novembru 2017)
English: Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date 19 May 2016)
Maltese: Studju CMEK162B2301, Parti 1: Plott Kaplan-Meier ta' sopravivenza ħielsa minn progressjoni reviżjoni ċentrali indipendenti (data tal-cut-off 19 ta' Mejju 2016)
English: • Grade 3 (CK > 5 - 10x upper limit of normal (ULN)) asymptomatic
Maltese: • Grad 3 (CK > 5 - 10x limitu ogħla tan-normal (ULN, upper limit of normal)) asintomatiku
English: a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Maltese: a Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer (NCI CTCAE) verżjoni 4.03
English: Preliminary Part 2 data at a cut-off date of 9 November 2016 demonstrated the contribution of binimetinib with an improved median PFS estimate of 12.9 months (95 % CI: 10.1, 14.0) for Combo 300 compared to 9.2 months (95 % CI: 7.4, 11.0) for Enco 300 (Parts 1 and 2) per independent central review (BIRC).
Maltese: Data preliminarja ta' Parti 2 f'data tal-cut-off tad-9 ta' Novembru 2016, uriet il-kontribuzzjoni ta' binimetinib bi stima ta' PFS medjana mtejba ta' 12.9 xhur (95 % CI: 10.1, 14.0) u għal Combo 300 meta mqabbel ma' 9.2 xhur (95 % CI: 7.4, 11.0) Enco 300 (Partijiet 1 u 2) skont ir-reviżjoni indipendenti (BIRC).
English: • some medicines to treat bacterial infections such as rifampicin, ciprofloxacin
Maltese: • xi mediċini għall-kura ta' infezzjonijiet batteriċi bħal rifampicin, ciprofloxacin
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E533b) Iron oxide yellow (E172) Iron oxide black (E172)
Maltese: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Diossidu tat-titanju (E171) Talk (E533b)
English: Interstitial lung disease (ILD)/pneumonitis • Grade 2
Maltese: Mard interstizjali tal-pulmun (ILD, interstitial lung disease)/pulmonite • Grad 2
English: Rhabdomyolysis/Creatine phosphokinase (CK) elevation
Maltese: Elevazzjoni ta' Rabdomijoliżi/Fosfokinażi tal-kreatina (CK, Creatine phosphokinase)
English: In vitro, CYP1A2 and CYP2C19 catalyse the formation of the active metabolite, which represents less than 20 % of the binimetinib exposure clinically.
Maltese: In vitro, CYP1A2 u CYP2C19 jikkatalizza lformazzjoni tal-metabolit attiv, li jirrappreżenta inqas minn 20 % tal-esponiment għal binimetinib b'mod kliniku.
English: Adverse reactions are listed below by MedDRA body system organ class and the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt skont is-sistema tal-klassifika tal-organi tal-ġisem MedDRA u skont il-konvenzjoni ta' frekwenza li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindromu tal-eritrodiżestija palmari-plantari
English: Binimetinib is metabolised by UGTs and CYP1A2 and is a substrate for Pgp.
Maltese: Binimetinib hu mmetabolizzat b'UGTs u b'CYP1A2 u hu sottostrat għal Pgp.
English: The median age of patients was 56 years (range 20-89), 58 % were male, 90 % were Caucasian, and 72 % of patients had baseline ECOG performance status of 0.
Maltese: L-età medjana tal-pazjenti kienet 56 sena (medda 20 - 89), 58 % kienu rġiel, 90 % kienu Kawkasi, u 72 % tal-pazjenti kellhom status tal-prestazzjoni ECOG fil-linja bażi ta' 0.
English: In the pooled Combo 450 population, photosensitivity was observed in 4.0 % (11/274) of patients.
Maltese: Fil-popolazzjoni Combo 450 miġbura, ġiet osservata l-fotosensittività f'4.0 % (11/274) tal-pazjenti.
English: • Symptomatic retinal pigment epithelial detachments (RPED) (Grade 2 or 3)
Maltese: • Distakkamenti epiteljali talpigment retinali (RPED, retinal pigment epithelial detachment) sintomatiċi (Grad 2 jew 3)
English: Cutaneous reactions • Grade2
Maltese: Reazzjonijiet tal-ġilda • Grad 2
English: • Recurrent Grade 4 adverse reactions
Maltese: • Reazzjonijiet avversi ta' Grad 4 rikorrenti
English: • Grade 3 or 4 LVEF decrease or symptomatic left ventricular dysfunction (LVD)
Maltese: • Tnaqqis fil-LVEF ta' Grad 3 jew 4 jew disfunzjoni sintomatika ventrikolari taxxellug (LVD, left ventricular dysfunction)
English: In patients treated with Combo 450, VTE occurred in 4.7 % (13/274) of patients, including 2.2 % (6/274) of patients who developed pulmonary embolism.
Maltese: F'pazjenti kkurati b'Combo 450, VTE seħħ f'4.7 % (13/274) tal-pazjenti, inkluż 2.2 % (6/274) tal pazjenti li żviluppaw emboliżmu pulmonari.
English: p value (stratified log-rank)b
Maltese: Enco 300) valur p (log-rank stratifikat)b
English: • Muscle problems: Mektovi can cause breakdown of muscle (rhabdomyolysis).
Maltese: • Problemi fil-muskoli: Mektovi jista' jikkawża kollass tal-muskolu (rabdomijoliżi).
English: How to store Mektovi 6.
Maltese: Kif taħżen Mektovi 6.
English: In urine, 6.5 % of the radioactivity was excreted as binimetinib.
Maltese: Fl-awrina, 6.5 % tar radjuattività ġie eliminat bħala binimetinib.