FrancophonIA/ELRC3.0 huggingface dataset:
English: The most serious observed adverse drug reactions in patients receiving Lonsurf are bone marrow suppression and gastrointestinal toxicity (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi serji osservati tal-mediċina f'pazjenti li qed jirċievu Lonsurf huma trażżin tal-mudullun u tossiċità gastrointestinali (ara sezzjoni 4.4).
English: In total, 507 patients were randomised 2:1 to receive Lonsurf (N = 337) plus best supportive care (BSC) or placebo (N = 170) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Maltese: B'kollox, 507 pazjenti kienu randomizzati 2:1 sabiex jirċievu Lonsurf (N = 337) kif ukoll l-aħjar kura ta' appoġġ (BSC) jew plaċebo (N = 170) kif ukoll BSC.
English: Tabulated list of adverse drug reactions
Maltese: Lista f'tabella tar-reazzjonijiet avversi tal-mediċina
English: A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily.
Maltese: Huwa permess massimu ta' 3 tnaqqis fid-doża għal doża minima ta' 20 mg/m darbtejn kuljum.
English: Of the 800 randomised patients, the median age was 63 years, 61% were male, 58% were Caucasian/White, 35% were Asian/Oriental, and 1% were Black/African American, and all patients had baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Maltese: Mit-800 pazjent randomizzat, l-età medjana kienet ta' 63 sena, 61% kienu rġiel, 58% kienu Kawkasi/Bojod, 35% kienu Asjatiċi/Orjentali, u 1% kienu Suwed/Amerikani Afrikani, u l-pazjenti kollha kellhom
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Lonsurf 15-il mg/6.14 mg pilloli miksija b'rita Lonsurf 20 mg/8.19 mg pilloli miksija b'rita
English: Visual acuity reduced Vision blurred Diplopia
Maltese: Akutezza fil-vista mnaqqsa Vista mċajpra Diplopja
English: An OS analysis of the study, carried out as planned at 72% (N = 574) of events, demonstrated a clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.68; 95% confidence interval [CI] [0.58 to 0.81]; p < 0.0001) and a median OS of 7.1 months vs 5.3 months, respectively; with 1-year survival rates of 26.6% and 17.6%, respectively.
Maltese: Analiżi OS tal-istudju, mwettqa kif ippjanatha f'72% (N = 574) tal-avvenimenti, uriet benefiċċju ta' sopravivenza klinikament relevanti u statistikament sinifikattiv ta' Lonsurf kif ukoll BSC meta mqabbel ma' plaċebo kif ukoll BSC (proporzjon ta' riskju: 0.68; 95% intervall ta' kunfidenza [CI] [0.58 sa 0.81]; p < 0.0001) u OS medjana ta' 7.1 xhur kontra 5.3 xhur, rispettivament; b'rati ta' sopravivenza ta' sena ta' 26.
English: Each pack contains 20 film-coated tablets (2 blisters of 10 tablets each) or 40 film-coated tablets (4 blisters of 10 tablets each), or 60 film-coated tablets (6 blisters of 10 tablets each).
Maltese: Kull pakkett fih 20 pillola miksija b'rita (2 folji ta' 10 pilloli l-waħda) jew 40 pillola miksija b'rita (4 folji ta' 10 pilloli l-waħda), jew 60 pillola miksija b'rita (6 folji ta' 10 pilloli l-waħda)
English: Metastatic gastric cancer
Maltese: Kanċer gastriku metastatiku
English: Patients 65 years of age or older who received Lonsurf had a higher incidence of the following events compared to patients younger than 65 years: - metastatic colorectal cancer (RECOURSE): Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anaemia (26% vs 12%), Grade 3 or 4 leukopenia (26% vs 18%) and Grade 3 or 4 thrombocytopenia (9% vs 2%), - metastatic gastric cancer (TAGS): Grade 3 or 4 neutrophil count decrease (17.0% vs 6.6%), decreased appetite (37.3% vs 31.9%), asthenia (22.2% vs 17.0%) and stomatitis (7.2% vs 2.2%).
Maltese: - kanċer kolorettali metastatiku (RECOURSE): Newtropenija Grad 3 jew 4 (48% vs 30%), anemija Grad 3 (26% vs 12%), lewkopenija Grad 3 jew 4 (26% vs 18%) u tromboċitopenija Grad 3 jew 4 (9% vs 2%), - kanċer gastriku metastatiku (TAGS):
English: EU/1/16/1096/006 60 film-coated tablets
Maltese: EU/1/16/1096/006 60 pillola miksija b'rita
English: See Section 4.8 for how to report adverse reactions.
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rappurtati reazzjonijiet avversi.
English: No correlation was seen for trifluridine nor tipiracil hydrochloride between PK parameters and AST or/and total blood bilirubin.
Maltese: Ma dehret ebda korrelazzjoni għal trifluridine lanqas għal tipiracil hydrochloride bejn il-parametri PK u AST u/jew it-total ta' bilirubin fid-demm.
English: DATE OF REVISION OF THE TEXT MM/YYYY
Maltese: DATA TA' REVIŻJONI TAT-TEST XX/SSSS
English: Total daily dose (mg)
Maltese: Id-doża (mg) totali f'jum
English: In a dose finding study (15 to 35 mg/m2 twice daily), the AUC from time 0 to 10 hours (AUC0-10) of trifluridine tended to increase more than expected based on the increase in dose; however, oral clearance (CL/F) and apparent volume of distribution (Vd/F) of trifluridine were generally constant at the dose range of 20 to 35mg/m2.
Maltese: Linearità/nuqqas ta' linearità Fi studju biex tinstab id-doża (15-il sa 35 mg/m darbtejn kuljum), l-AUC mill-ħin 0 sa 10 sigħat (AUC0-10) ta' trifluridine kellu t-tendenza li jiżdied aktar milli mistenni abbażi ż-żieda fid-doża; madankollu, it-tneħħija mil-ħalq (CL/F) u l-volum apparenti tad-distribuzzjoni (Vd/F) ta' trifluridine kienu ġeneralment kostanti fil-medda tad-doża ta' 20 sa 35mg/m2.
English: Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 20 mg trifluridine u 8.19 mg tipiracil (bħala hydrochloride).
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien S.A. Servier Benelux N.V.
English: Following the multiple-dose administration of Lonsurf at the recommended dose and regimen, the mean elimination half-life (t1/2) for trifluridine on Day 1 of Cycle 1 and on Day 12 of Cycle 1 were 1.4 hours and 2.1 hours, respectively.
Maltese: Wara l-għoti ta' dożi multipli ta' Lonsurf bid-doża u l-kors rakkomandati, il-medja tal-half-life taleliminazzjoni (t1/2) ta' trifluridine fil-Jum 1 taċ-Ċiklu 1 u fil-Jum 12 taċ-Ċiklu 1 kienu 1.4 sigħat u 2.1 sigħat, rispettivament.
English: Recommended dose adjustments
Maltese: Modifikazzjonijiet tad-doża rakkomandati
English: Febrile neutropenia Lymphopenia
Maltese: Uġigħ orofarinġeali Epistassi
English: The DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44% vs 16%, p < 0.0001).
Maltese: Id-DCR (rispons sħiħ jew rispons parzjali jew marda stabbli) kien ogħla b'mod sinifikanti f'pazjenti kkurati b'Lonsurf (44% kontra 16%, p < 0.0001).
English: mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups.
Maltese: L-inċidenza globali ta' avvenimenti avversi (AEs) hija simili f'sottogruppi b'funzjoni normali talkliewi (CrCl ≥ 90 mL/min), indeboliment tal-kliewi ħafif (CrCl = 60 sa 89 mL/min) jew moderat (CrCl = 30 sa 59 mL/min).
English: Tipiracil hydrochloride was an inhibitor of OCT2 and MATE1 in vitro, but at concentrations substantially higher than human plasma Cmax at steady state.
Maltese: Tipiracil hydrochloride kien inibitur ta' OCT2 u MATE1in vitro, imma f'konċentrazzjonijiet ogħla b'mod sostanzjali mill-plażma tal-bniedem Cmax flistat fiss.
English: Neurotoxicity Dysaesthesia Hyperaesthesia Hypoaesthesia Syncope
Maltese: Newrotossiċità Disestesija Iperestesija Ipostesija
English: EU/1/16/1096/005 40 film-coated tablets
Maltese: EU/1/16/1096/005 40 pillola miksija b'rita
English: • you have kidney problems
Maltese: • jekk għandek problemi fil-kliewi
English: After oral administration of Lonsurf with [14C]-trifluridine, at least 57% of the administered trifluridine was absorbed and only 3% of the dose was excreted into faeces.
Maltese: C]-trifluridine, mill-anqas 57% ta' trifluridine mogħti kien assorbit u 3% biss tad-doża ġiet eliminata fl-ippurgar.
English: Photosensitivity reaction Erythema
Maltese: Reazzjoni ta' fotosensittività Eritema
English: Based on a population PK analysis, the exposure of Lonsurf in patients with mild renal impairment (CrCl = 60 to 89 mL/min) was similar to those in patients with normal renal function (CrCl ≥ 90 mL/min).
Maltese: Abbażi tal-analiżi PK tal-popolazzjoni, l-esponiment ta' Lonsurf f'pazjenti b'indeboliment ħafif talkliewi (CrCl 60 sa 89 mL/min) kien simili għal dak f'pazjenti b'funzjoni normali tal-kliewi (CrCl ≥ 90 mL/min).
English: The primary efficacy endpoint was overall survival (OS), and supportive efficacy endpoints were progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), time to deterioration of ECOG performance status ≥2 and Quality of Life (QoL).
Maltese: Il-punt aħħari primarju ta' effikaċja kien sopravivenza totali (OS) u l-punti aħħarija sekondarji ta' effikaċja kienu sopravivenza bla progressjoni (PFS), rata ta' rispons globali (ORR), rata għall-kontroll tal-mard (DCR), żmien għaddeterjorazzjoni tal-istatus tal-prestazzjoni ECOG ≥2 u Kwalità tal-Ħajja (QoL).
English: An updated OS analysis, carried out at 89% (N = 712) of events, confirmed the clinically meaningful and statistically significant survival benefit of Lonsurf plus BSC compared to placebo plus BSC (hazard ratio: 0.69; 95% CI [0.59 to 0.81]; p < 0.0001) and a median OS of 7.2 months vs 5.2 months; with 1-year survival rates of 27.1% and 16.6%, respectively.
Maltese: Analiżi OS tal-istudju aġġornata, mwettqa kif ippjanatha f'89% (N = 712) tal-avvenimenti, ikkonfermat il-benefiċċju ta' sopravivenza klinikament relevanti u statistikament sinifikattiv ta' Lonsurf kif ukoll BSC meta mqabbel ma' plaċebo kif ukoll BSC (proporzjon ta' riskju: 0.69; 95% CI [0.59 sa 0.81]; p < 0.0001) u OS medjana ta' 7.2 xhur kontra 5.2 xhur; b'rati ta' sopravivenza ta' sena ta' 27.
English: Impaired gastric emptying Abdominal distension Anal inflammation Mouth ulceration Dyspepsia
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: Candida infection Bacterial infection Infection
Maltese: Infezzjoni tal-candida Infezzjoni batterjali Infezzjoni
English: • rash, itchy or flaky skin
Maltese: • raxx, ħakk jew qxur fil-ġilda
English: In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP1A2, CYP2B6 or CYP3A4/5.
Maltese: Evalwazzjoni in vitro indikat li trifluridine, tipiracil hydrochloride u FTY ma kellhomx effett ta' induzzjoni fuq CYP1A2, CYP2B6 jew CYP3A4/5 talbnedmin.
English: An OS analysis of the study, carried out as planned at 76% (N = 384) of events, demonstrated that Lonsurf plus BSC resulted in a statistically significant improvement in OS compared to placebo plus BSC with an hazard ratio (HR) of 0.69 (95% CI: 0.56, 0.85; 1- and 2-sided p-values were 0.0003 and 0.0006, respectively) corresponding to a 31% reduction in the risk of death in the Lonsurf group.
Maltese: Analiżi OS tal-istudju, imwettqa kif ippjanata f'76% (N = 384) tal-avvenimenti, uriet li Lonsurf kif ukoll BSC irriżulta f'titjib statistikament sinifikattiv fl-OS meta mqabbel ma' plaċebo kif ukoll BSC bi proporzjon ta' riskju (HR) ta' 0.69 (95% CI: 0.56, 0.85; il-valuri p ta' naħa waħda u taż-żewġ naħiet kienu 0.0003 u 0.0006, rispettivament) li jikkorrispondu għal tnaqqis ta' 31 % fir-riskju ta' mewt filgrupp ta' Lonsurf.
English: The tablet is a white, biconvex, round, film-coated tablet, with a diameter of 7.1 mm and a thickness of 2.7 mm, imprinted with ‘15' on one side, and ‘102' and '15 mg' on the other side, in grey ink.
Maltese: Il-pillola miksija b'rita hija bajda, mżaqqa miż-żewġ naħat, tonda, b'dijametru ta' 7.1 mm u ħxuna ta' 2.7 mm, b''15' stampata fuq naħa waħda, u ‘102' u ‘15 mg' fuq in-naħa l-oħra, b'linka griża.
English: Based upon limited data with a considerable variability, no statistically significant differences were observed in the pharmacokinetics in patients with normal hepatic function versus patients with mild or moderate hepatic impairment.
Maltese: Abbażi ta' dejta limitata b'varjabbiltà konsiderevoli, ebda differenza statistikament sinifikanti ma ġiet osservata fil-farmakokinetiċi f'pazjenti b'funzjoni tal-fwied normali kontra pazjenti b'indeboliment tal-fwied ħafif jew moderat.
English: The incidences of Grade ≥3 neutropenia were higher in the high trifluridine AUC group (47.8%) compared with the low-trifluridine AUC group (30.4%).
Maltese: L-inċidenzi ta' newtropenija tal-Grad ≥ 3 kienu ogħla fil-grupp tal-AUC ta' trifluridine għoli (47.8%) meta mqabbla mal-grupp tal-AUC ta' trifluridine baxx (30.
English: Single-dose administration of Lonsurf (35 mg/m2/dose) increased the mean AUC0-last of trifluridine by 37-fold and Cmax by 22-fold with reduced variability compared to trifluridine alone (35 mg/m2/dose).
Maltese: L-għoti ta' doża waħda ta' Lonsurf (35 mg/m 2/doża) żied l-AUC 0-last medju ta' trifluridine b'37-darba u Cmax bi 22-darba b'varjabilità mnaqqsa meta mqabbel ma' trifluridine biss (35 mg/m 2/doża).
English: Bone marrow suppression
Maltese: Mard perjodontali
English: Hyponatraemia
Maltese: Tromboċitopenija
English: Transport of tipiracil hydrochloride by OCT2 and MATE1 might be affected when Lonsurf is administered concomitantly with inhibitors of OCT2 and MATE1.
Maltese: It-trasport ta' tipiracil hydrochloride permezz ta' OCT2 u MATE1 jista' jkun affetwat meta Lonsurf huwa mogħti b'mod konkomitanti b'inibituri ta' OCT2 u MATE1.
English: Lonsurf is not recommended for use in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN), as a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see section 5.2).
Maltese: Lonsurf mhuwiex rakkomandat għall-użu f'pazjenti b'indeboliment tal-linja bażi moderat jew sever tal-fwied (Kriterji tal-Istitut Nazzjonali tal-Kanċer [NCI] tal-Grupp C u D definiti minn total ta' bilirubin > 1.5 x ULN), peress li hi osservata inċidenza ogħla ta' iperbilirubinemja ta' Grad 3 jew 4 f'pazjenti b'indeboliment tal-linja bażi moderat tal-fwied, għalkemm dan hu bbażat fuq dejta limitata ħafna (ara sezzjoni 5.2)
English: • cough, feeling short of breath, infection of the sinuses, throat, airway or lungs, chest infections
Maltese: • sogħla, tħossok nifsek maqtugħ, infezzjoni tas-sinus, griżmejn, passaġġ tal-arja jew pulmun,
English: However, there was no accumulation for tipiracil hydrochloride, and no further accumulation of trifluridine with successive cycles (Day 12 of Cycles 2 and 3) of administration of Lonsurf.
Maltese: Madankollu, ma kienx hemm akkumulazzjoni ta' tipiracil hydrochloride, u ma kienx hemm aktar akkumulazzjoni ta' trifluridine b'ċikli suċċessivi (Jum 12 taċ-Ċikli 2 u 3) tal-għoti ta' Lonsurf.
English: Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 15-il mg trifluridine u 6.14 mg tipiracil (bħala hydrochloride).
English: In vitro evaluation indicated that trifluridine, tipiracil hydrochloride and FTY had no inductive effect on human CYP isoforms (see section 5.2).
Maltese: Evalwazzjoni in vitro indikat li trifluridine, tipiracil hydrochloride u FTY ma kellhomx effett ta' induzzjoni fuq l-iżoformi CYP talbnedmin (ara sezzjoni 5.2).
English: Talk to your doctor about whether to switch to a different HIV medicine.
Maltese: Kellem lit-tabib tiegħek dwar jekk għandekx tbiddel għal mediċina differenti tal-HIV.
English: • feeling dizzy, headache
Maltese: • tħossok sturdut, uġigħ ta' ras
English: What you need to know before you take Lonsurf 3.
Maltese: X'għandek tkun taf qabel ma tieħu Lonsurf 3.
English: EU/1/16/1096/001 20 film-coated tablets EU/1/16/1096/002 40 film-coated tablets EU/1/16/1096/003 60 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1096/001 20 pillola miksija b'rita
English: In a dedicated study the PK of trifluridine and tipiracil hydrochloride were evaluated in cancer patients with mild or moderate hepatic impairment (National Cancer Institute [NCI] Criteria Group B and C, respectively) and in patients with normal hepatic function.
Maltese: Fi studju dedikat, il-PK ta' trifluridine u tipiracil hydrochloride ġew evalwati f'pazjenti b'kanċer b'indeboliment ħafif jew moderat tal-fwied (Kriterji tal-Istitut Nazzjoanli tal-Kanċer [NCI] Grupp B u Ċ, rispettivament) u f'pazjenti b'funzjoni tal-fwied normali.
English: It is currently unknown whether Lonsurf may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier contraceptive method.
Maltese: Attwalment mhuwiex magħruf jekk Lonsurf jistax inaqqas l-effettività ta' kontraċettivi ormonali, u għaldaqstant in-nisa li qegħdin jużaw kontraċettivi ormonali għandhon iżidu metodu ta' kontraċezzjoni tat-tip barriera.
English: Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110
Maltese: Tel: +353 (0)1 663 8110
English: Administration is not recommended in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin > 1.5 x ULN) as, a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see sections 4.4 and 5.2).
Maltese: L-għoti mhuwiex rakkomandat f'pazjenti b'indeboliment tal-linja bażi moderat jew sever tal-fwied (Kriterji tal-Istitut Nazzjonali tal-Kanċer [NCI, National Cancer Institute] definiti minn total ta' bilirubin > 1.5 x ULN) peress li hi osservata inċidenza ogħla ta' iperbilirubinemja ta' Grad 3 jew 4 f'pazjenti b'indeboliment tal-linja bażi moderat tal-fwied, għalkemm dan hu bbażat fuq dejta limitata ħafna (ara sezzjonijiet 4.4 u 5.2).
English: The CHMP reviewed the data submitted by the marketing authorisation holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report.
Maltese: • sena waħda ta' protezzjoni tal-kummerċjalizzazzjoni Is-CHMP irreveda d-data sottomessa mid-Detentur ta' Awtorizzazzjoni għat-Tqegħid fis-Suq, filwaqt li kkunsidra d-dispożizzjonijiet tal-Artikolu 14(11) tar-Regolament (KE) Nru 726/2004, u jqis li lindikazzjonijiet terapewtiċi ġodda jġibu magħhom benefiċċju kliniku sinifikanti meta mqabbla ma' terapiji eżistenti, kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: Tipiracil hydrochloride was a substrate for OCT2 and MATE1, therefore, the concentration might be increased when Lonsurf is administered concomitantly with inhibitors of OCT2 or MATE1.
Maltese: Tipiracil hydrochloride kien sottostrat ta' OCT2 u MATE1, għaldaqstant, ilkonċentrazzjoni tista' tiżdied meta Lonsurf jingħata b'mod konkomitanti ma' inibituri ta' OCT2 jew MATE1.
English: Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity
Maltese: Uġigħ muskolu-skeletriku Dgħufija muskolari Spażmi fil-muskoli Uġigħ fl-estremitajiet
English: All changes, i.e., leukopenia, anaemia, bone marrow hypoplasia, atrophic changes in the lymphatic and haematopoietic tissues and the gastrointestinal tract, were reversible within 9 weeks of drug withdrawal.
Maltese: Il-bidliet kollha, jiġifieri lewkopenija, anemija, ipoplasja tal-mudullun, bidliet atrofiċi fit-tessuti limfatiċi u ematopojtiċi u l-passaġġ gastrointestinali, kienu riversibbli fi żmien 9 ġimgħat mit-twaqqif tal-mediċina.
English: • a reduced number of red blood cells (anaemia)
Maltese: • numru mnaqqas ta' ċelloli ħomor tad-demm (anemija)
English: Lonsurf 15 mg/6.14 mg film-coated tablets Hypromellose
Maltese: Lonsurf 15-il mg/6.14 mg pilloli miksija b'rita Hypromellose
English: • raised itchy rash, red skin, blisters, skin sloughing off, hives, acne
Maltese: • raxx imqabbeż li jqabbad il-ħak, ġilda ħamra, infafet, ġilda mejta li taqa', urtikarja, akne
English: Sixty one percent (61%, N = 485) of all randomised patients received a fluoropyrimidine as part of their last treatment regimen prior to randomisation, of which 455 (94%) were refractory to the fluoropyrimidine at that time.
Maltese: Wieħed u sittin fil-mija (61%, N = 485) tal-pazjenti randomizzati kollha rċevew fluoropyrimidine bħala parti mill-aħħar kors tal-kura tagħhom qabel ir-randomizzazzjoni, li minnhom 455 (94%) kienu refrattarji għal fluoropyrimidine dak iż-żmien.
English: • burning sensation, unpleasant, increased or loss of sense of touch and other non-severe neurological troubles
Maltese: • sensazzjoni ta' ħruq, sens tal-mess spjaċevoli, miżjud jew imnaqqas u problemi newroloġiċi mhux severi oħrajn
English: The recommended starting dose of Lonsurf in adults is 35 mg/m2/dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4).
Maltese: Id-doża tal-bidu rakkomandata ta' Lonsurf fl-adulti hija ta' 35 mg/m2/doża mogħtija mill-ħalq darbtejn kuljum fil-Jiem 1 sa 5 u l-Jiem 8 sa 12 ta' kull ċiklu ta' 28-jum sakemm il-benefiċċju hu osservat jew sakemm isseħħ tossiċità inaċċettabbli (ara sezzjoni 4.4).
English: Nearly all (99.8%) patients received prior fluoropyrimidine, 100% received prior platinum therapy and 90.5% received prior taxane therapy.
Maltese: In-numru medjan ta' korsijiet preċedenti ta' terapija għal marda metastatika kien 3. Kważi l-pazjenti kollha (99.8%) irċivew fluoropyrimidine preċedenti, 100 % irċivew terapija preċedenti bil-platinu u 90.5 % irċivew terapija preċedenti bit-tassan.
English: Lonsurf contains lactose.
Maltese: Lonsurf fih il-lactose.
English: • runny or bloody nose, sinus problems
Maltese: • imnieħer inixxi jew bi fsada, problemi fis-sinus
English: Median PFS (months)a [95% CI]b Hazard ratio [95% CI] P-valuec
Maltese: Sopravivenza Bla Progressjoni Numru ta' Progressjoni jew Mewt, N (%) PFS medjana (xhur)
English: Gingival bleeding Glossitis
Maltese: Newtropenija bid-deni Linfopenija
English: Lonsurf is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance [CrCl] < 30 mL/min or requiring dialysis, respectively), as Lonsurf has not been studied in these patients (see section 5.2).
Maltese: Lonsurf mhuwiex rakkomandat f'pazjenti b'indeboliment sever tal-kliewi jew mard tal-kliewi talaħħar stadju (tneħħija tal-krejatinina [CrCl] < 30 mL/min jew ħtieġa ta' dijaliżi, rispettivament), minħabba li Lonsurf ma ġiex studjat f'dawn il-pazjenti (ara sezzjoni 5.2).
English: • more noticeable heart-beat, chest pain
Maltese: • bidliet fit-test tal-awrina, demm fl-awrina
English: Serum albumin was found to significantly affect trifluridine clearance, with a negative correlation.
Maltese: Instab li l-albumina tasserum taffetwa b'mod sinfikanti it-tneħħija ta' trifluridine, b'korrelazzjoni negattiva.
English: What Lonsurf contains Lonsurf 15 mg/6.14 mg tablet
Maltese: X'fih Lonsurf Lonsurf 15 mg/6.14 mg pillola
English: Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease (see section 5.1).
Maltese: Lonsurf huwa indikat bħala monoterapija għall-kura ta' pazjenti adulti li jbatu mill-kanċer gastriku metastatiku li jinkludi adenokarċinoma tal-ġunzjoni gastroesofagali, li kienu kkurati qabel b'tal-inqas żewġ korsijiet ta' kura sistemika preċedenti għal marda avvanzata (ara sezzjoni 5.1).
English: Figure 2 - Kaplan-Meier curves of progression-free survival in patients with metastatic colorectal cancer
Maltese: Kaplan-Meier għas-sopravivenza bla progressjoni f'pazjenti bil-kanċer kolorettali metastatiku
English: • accumulation of fluid in the lungs
Maltese: • akkumulazzjoni tal-fluwidu fil-pulmun
English: Lonsurf 20 mg/8.19 mg film-coated tablets Hypromellose
Maltese: Lonsurf 20 mg/8.19 mg pilloli miksija b'rita Hypromellose