FrancophonIA/ELRC3.0 huggingface dataset:
English: Each MAH shall develop training materials according to the following core elements:
Maltese: Kull MAH għandu jiżviluppa materjal ta' taħriġ skont l-elementi ewlenin li ġejjin:
English: The MAHs are strongly encouraged to collaborate to perform a joint study.
Maltese: Il-MAHs huma mħeġġa bil-qawwa biex jikkollaboraw biex iwettqu studju konġunt.
English: It is available as blue (20 mg) and orange (40 mg) capsules.
Maltese: Huwa disponibbli f'kapsuli blu (20 mg) u oranġjo (40 mg).
English: Yentreve has been studied in a total of 2,850 women with SUI.
Maltese: Yentreve ġie studjat f'total ta' 2,850 mara b'SUI.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) YENTREVE EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) YENTREVE Sommarju ta' l-EPAR għall-pubbliku
English: Yentreve is a medicine containing the active substance duloxetine.
Maltese: Yentreve hija mediċina li fiha s-sustanza attiva duloxetine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yentreve to Eli Lilly Nederland B.V. on 11 August 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Yentreve lil Eli Lilly Nederland B.V. fil-11 ta' Awissu 2004.
English: Yentreve should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Maltese: Yentreve ma għandux jintuża flimkien ma' inibituri talmonoaminoossidażi (monoamine oxidase inhibitors, grupp ta' antidepressivi), fluvoxamine (antidipressiv ieħor), jew ciprofloxacin jew enoxacin (tipi ta' antibijotiċi).
English: The IEF decreased by 52% in the Yentreve group, compared with a decrease of 33% in the placebo-treated group.
Maltese: L-IEF naqset bi 52% fil-grupp ta' Yentreve, kontra tnaqqis ta' 33% fil-grupp ittrattat bil-plaċebo.
English: The active substance in Yentreve, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor (SNRI).
Maltese: Is-sustanza attiva f'Yentreve, duloxetine, hija inibitur ta' l-assorbiment mill-ġdid tas-serotonina u tannoradrenalina (SNRI, serotonin-noradrenaline reuptake inhibitor).
English: Why has Yentreve been approved?
Maltese: Għaliex ġie approvat Yentreve?
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni relatata mar-rakkomandazzjonijiet ta' CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: The four main studies involved 1,913 women and lasted 12 weeks, comparing Yentreve (mostly as 40 mg twice daily) with placebo (a dummy treatment).
Maltese: L-erba' studji prinċipali involvew 1,913-il mara u damu 12-il ġimgħa u qabblu Yentreve (l-aktar bħala doża 40 mg darbtejn kuljum) mal-plaċebo
English: Other information about Yentreve:
Maltese: Aktar tagħrif dwar Yentreve:
English: What is Yentreve?
Maltese: Kif jintuża Yentreve?
English: Yentreve is used to treat moderate to severe stress urinary incontinence (SUI) in women.
Maltese: Yentreve jintuża għat-trattament ta' l-inkontinenza urinarja minn sforz (SUI - stress urinary incontinence) minn moderata għal gravi fin-nisa.
English: How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
Maltese: L-azzjoni ta' duloxetine fi SUI mhijiex ċara, iżda jitqies li, billi żżid il-livelli ta' 5-idrossitripamina e noradrenalina fil-livell tan-nervituri li jikkontrollaw il-muskolatura ta' l-uretra (il-kanal li jgħaqqad il-bużżieqa ma' barra), duloxetine tikkawża għeluq ta' l-uretra aktar bis-saħħa waqt il-bużżieqa timtela bl-awrina.
English: The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients' scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
Maltese: Il-kejl ewlieni ta' l-effikaċja kienu l-frekwenza ta' l-episodji ta' inkontinenza (IEF, jiġifieri l-għadd ta' episodji ta' inkontinenza kull ġimgħa) imniżżla fuq djarju tal-pazjenti u l-punteġġ tal-pazjenti fuq il-bażi ta' kwestjonarju ta' kwalità tal-ħajja speċifiku għall-inkontinenza (I-QOL).
English: The benefit of treatment should be re-assessed at regular intervals.
Maltese: Il-benefiċċju tattrattament għandu jiġi valutat mill-ġdid f'intervalli ta' żmien regolari.
English: The I-QOL questionnaire scores were also improved in the Yentreve group compared with the placebo group.
Maltese: Il-punteġġi tal-kwestjonarju I-QOL tjiebu wkoll fil-grupp tal-pazjenti ttrattati b'Yentreve meta mqabbel mal-grupp ittrattat bil-plaċebo.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Yentreve's benefits are greater than its risks for the treatment of moderate to severe SUI.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċju ta' Yentreve huma ogħla mir-riskji tiegħu fit-trattament ta' l-inkontinenza urinarja minn sforz minn moderata għal gravi.
English: The recommended dose of Yentreve is 40 mg twice a day.
Maltese: Id-doża rrakkomandata ta' Yentreve hi 40 mg darbtejn kuljum.
English: Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Maltese: Xi pazjenti jistgħu jiksbu benefiċċju minn trattament inizjali b'doża ta' 20 mg darbtejn kuljum għal ġimagħtejn qabel ma jgħaddu għaddoża rakkomandata ta' 40 mg, biex inaqqsu n-nawżea (dardir) u l-isturdament.
English: Combining Yentreve with pelvic floor muscle training may provide additional benefit.
Maltese: Li tgħaqqad Yentreve ma' programm ta' eżerċizzju tal-muskolatura tal-qiegħ pelviku (pelvic floor) jista' jagħti aktar benefiċċju.
English: What is the risk associated with Yentreve?
Maltese: X'inhu r-riskju assoċjat ma' Yentreve?
English: The most common side effects with Yentreve (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Yentreve (li dehru f'aktar minn pazjent 1 minn kull 10) huma nawżea, ħalq xott, stitikezza u għeja.
English: How does Yentreve work?
Maltese: Kif ġie studjat Yentreve?
English: Yentreve was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Maltese: Yentreve irriżulta aktar effikaċi mill-plaċebo biss fil-pazjenti li kellhom iktar minn 14-il episodju ta' inkontinenza fil-ġimgħa (SUI minn moderata għal gravi) fil-bidu ta' l-istudju.
English: Survival Probability (%)
Maltese: Probabilità ta' Sopravivenza (%)
English: Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy
Maltese: Les Laboratoires Servier Industrie 905, route de Saran 45520
English: • gastrointestinal problems.
Maltese: • problemi gastrointestinali.
English: System Organ Class (MedDRA)a
Maltese: Sistema tal-Klassifika tal-Organi (MedDRA)
English: Summary of safety profile
Maltese: Sommarju ta' profil tas-sigurtà
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 April 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 ta' April 2016
English: b. Fatal cases have been reported.
Maltese: b. Ġew irrapportati każi fatali.
English: Les Laboratoires Servier 50 rue Carnot 92284 Suresnes Cedex France
Maltese: Les Laboratoires Servier 50 rue Carnot 92284
English: S.A. Servier Benelux N.V.
Maltese: Luxembourg/Luxemburg S.A. Servier Benelux N.V.
English: • feeling of spinning (vertigo)
Maltese: • sensazzjoni ta' tidwir (vertigo)
English: Lonsurf contains two different active substances: trifluridine and tipiracil.
Maltese: Lonsurf fih żewġ sustanzi attivi differenti: trifluridine u tipiracil.
English: Pulmonary embolismb
Maltese: Emboliżmu pulmonari b
English: Frequency groups are defined by the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); and uncommon (≥1/1,000 to < 1/100).
Maltese: Il-gruppi ta' frekwenza huma definiti permezz tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); u mhux komuni (≥1/1,000 sa < 1/100).
English: Menstrual disorder
Maltese: Disturbi menstruwali
English: Aluminium/Aluminium blister with laminated desiccant (Calcium oxide) containing 10 tablets.
Maltese: Aluminju/Folja tal-aluminju b'dessikant laminat (Calcium oxide) li fiha 10 pilloli.
English: Contribution of tipiracil hydrochloride
Maltese: Kontribut ta' tipiracil hydrochloride
English: 0.0003 (1-sided), 0.0006 (2-sided)
Maltese: 0.0003 (naħa waħda), 0.0006 (żewġ naħiet)
English: Gastrointestinal toxicity
Maltese: Tossiċità gastrointestinali
English: 92284 Suresnes Cedex France
Maltese: Suresnes Cedex Franza
English: Pleural effusion Rhinorrhoea Dysphonia Oropharyngeal pain Epistaxis
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Based on the population PK analysis, liver function parameters including alkaline phosphatase (ALP, 36-2322 U/L), aspartate aminotransferase (AST, 11-197 U/L), alanine aminotransferase (ALT, 5-182 U/L) , and total bilirubin (0.17-3.20 mg/dL) were not significant covariates for PK parameters of either trifluridine or tipiracil hydrochloride.
Maltese: Abbażi tal-analiżi PK tal-popolazzjoni, il-parametri tal-funzjoni tal-fwied inkludew alkaline phosphatase (ALP, 36-2322 U/L), aspartate aminotransferase (AST, 11-197 U/L), alanine aminotransferase (ALT, 5-182 U/L), u bilirubin totali (0.17-3.20 mg/dL) ma kinux kovarjanti sinifikanti għall-parametri PK jew ta' trifluridine jew tipiracil hydrochloride.
English: Lactose monohydrate Starch, Pregelatinised (Maize) Stearic acid
Maltese: Lactose monohydrate Lamtu, Preġelatinizzat (Qamħirrum) Aċidu stearic
English: Enterocolitis haemorrhagic Gastrointestinal haemorrhage Pancreatitis acute Ascites
Maltese: Enterokolite emorraġika Emorraġija gastrointestinali Pankreatite akuta Axxite
English: • Anaemia (very common).
Maltese: • Anemija(komuni ħafna).
English: C-reactive protein increased
Maltese: Proteina C-reattiva miżjuda
English: < 0.5 × 109/L
Maltese: (< 0.5 x 10
English: • athlete's foot - fungal infection of feet, yeast infections
Maltese: • athlete's foot - infezzjoni fungali tas-sieq, kandidjażi
English: Repeat-dose toxicity
Maltese: Tossiċità minn dożi ripetuti
English: How to take Lonsurf
Maltese: Tiħux Lonsurf
English: Each film-coated tablet contains 90.735 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 90.735 mg ta' lactose monohydrate.
English: INFORMATION IN BRAILLE Lonsurf 20 mg/8.19 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lonsurf 20 mg/8.19 mg
English: • blood test result indicating inflammation (C-Reactive Protein increased)
Maltese: • riżultat tat-test tad-demm li jindika infjammazzjoni (żieda fil-Proteina C-Reattiva)
English: • Severe gastrointestinal problems: abdominal pain (common), ascites (uncommon), colitis (uncommon), acute pancreatitis (uncommon), ileus (uncommon) and subileus (uncommon).
Maltese: • Problemi gastrointestinali severi: uġigħ addominali (komuni), axxite (mhux komuni), kolite (mhux komuni), pankreatite akuta (mhux komuni), ileus (mhux komuni) u subileus (mhux komuni).
English: The most frequently observed adverse drug reactions (≥ 30%) in patients receiving Lonsurf are neutropenia (53% [34% ≥ Grade 3]), nausea (34% [1% ≥ Grade 3]), fatigue (32% [4% ≥ Grade 3]), anaemia (32% [12% ≥ Grade 3]).
Maltese: L-aktar reazzjonijiet avversi tal-mediċina frekwenti osservati (≥ 30%) osservati f'pazjenti li qed jirċievu Lonsurf huma newtropenija (53% [34% ≥ Grad 3]), dardir (34% [1% ≥ Grad 3]), għejja (32% [4% ≥ Grad 3]), anemija (32% [12% ≥ Grad 3]).
English: Dose in mg (2x daily)
Maltese: Doża f'mg (2x kuljum)
English: INFORMATION IN BRAILLE Lonsurf 15 mg/6.14 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lonsurf 15 mg/6.14 mg
English: Angina pectoris Arrhythmia Palpitations
Maltese: Anġina pectoris Arritmija Palpitazzjonijiet
English: Τηλ: +30 210 939 1000
Maltese: ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: +30 210 939 1000
English: In vitro studies indicated that trifluridine is a substrate for the nucleoside transporters CNT1, ENT1 and ENT2.
Maltese: Studji in vitro indikaw li trifluridine huwa sottostrat għat-trasportaturi tan-nukleosajd CNT1, ENT1 u ENT2.
English: In vitro evaluation of trifluridine and tipiracil hydrochloride was conducted using human uptake and efflux transporters (trifluridine with MDR1, OATP1B1, OATP1B3 and BCRP; tipiracil hydrochloride with OAT1, OAT3, OCT2, MATE1, MDR1 and BCRP).
Maltese: Evalwazzjoni in vitro ta' trifluridine u tipiracil hydrochloride twettqet bl-użu tal-assorbiment talbniedem u trasportaturi tal-effluss (trifluridine b'MDR1, OATP1B1, OATP1B3 u BCRP; tipiracil hydrochloride b'OAT1, OAT3, OCT2, MATE1, MDR1 u BCRP).
English: KRAS status was wild (49%) or mutant (51%) at study entry.
Maltese: L-istatus KRAS kien salvaġġ (49%) jew mutanti (51%) mad-dħul fl-istudju.
English: Haematocrit decreased a. Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term.
Maltese: Termini preferuti differenti tal-MedDRA li kienu meqjusa klinikament simili kienu miġbura f'terminu wieħed.
English: 1a
Maltese: 1a a
English: NAME OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
Maltese: FIS-SUQ Les Laboratoires Servier
English: In vitro studies indicated that trifluridine, tipiracil hydrochloride and FTY (inactive metabolite of trifluridine) did not inhibit the CYP isoforms tested (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5).
Maltese: Studji in vitro indikaw li trifluridine, tipiracil hydrochloride u FTY (metabolit inattiv ta' trifluridine) ma impedixxux l-iżoformi CYP ittestjati (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 u CYP3A4/5).
English: • Thrombocytopenia (very common).
Maltese: • Tromboċitopenija(komuni ħafna).
English: Servier Italia S.p.A. Tel: +39 06 669081
Maltese: Tel: +39 06 669081
English: In RECOURSE and TAGS studies, 9.4% and 17.3% of patients in the Lonsurf group respectively received G-CSF mainly for therapeutic use.
Maltese: Flistudji RECOURSE u TAGS, 9.4% u 17.3 % tal-pazjenti fil-grupp Lonsurf rispettivament irċevew G-CSF primarjament għall-użu terapewtiku.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC59 Mechanism of action
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, antimetaboliti, kodiċi ATC:
English: Reflux gastritis
Maltese: Rifluss gastrite
English: Hazard ratio [95% CI] P-valuec
Maltese: Proporzjon ta' riskju [95% CI] Valur P
English: • low levels of phosphates, sodium, potassium or calcium in your blood
Maltese: • livelli baxxi ta' phosphates, sodium, potassium jew calcium fid-demm tiegħek
English: Tablets per dose (2x daily)
Maltese: Pilloli għal kull doża (2x kuljum)
English: Trifluridine was mainly eliminated by metabolism via TPase to form an inactive metabolite, FTY.
Maltese: Trifluridine kien prinċiparjament eliminat mill-metaboliżmu permezz ta' TPase sabiex jifforma metabolit inattiv, FTY.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1096/001-006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1096/001-006
English: Iron oxide red (E172) Iron oxide yellow (E172) Titanium dioxide (E171) Indigo carmine aluminium lake (E132) Carnauba wax
Maltese: Iron oxide red (E172) Iron oxide yellow (E172) Titanium dioxide (E171) Indigo carmine aluminium lake (E132) Xemgħa tal-karnawba Talc
English: Papaellinas Ltd. Τηλ: +357 22741741
Maltese: Τηλ: +357 22741741
English: Approximately half (55.4%) of patients received prior irinotecan, 33.3% received prior ramucirumab, and 16.6% received prior HER2-targeted therapy.
Maltese: Bejn wieħed u ieħor nofs (55.4%) il-pazjenti rċivew irinotecan preċedenti, 33.3 % irċivew ramucirumab preċedenti, u 16.6 % irċivew terapija preċedenti mmirata lejn HER2.
English: Lonsurf is comprised of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride, at a molar ratio 1:0.5 (weight ratio,
Maltese: Lonsurf huwa magħmul minn analogu tan-nukleosidi antineoplastiku bbażata fuq thymidine, u linibitur ta' thymidine phosphorylase (TPase), tipiracil hydrochloride, bi proporzjon molari 1:0.5
English: Level 2 dose reduction: From 30 mg/m2 to 25 mg/m2 25 mg/m2
Maltese: Tnaqqis fid-doża ta' livell 2: Minn 30 mg/m sa 25 mg/m25 mg/m a
English: Gastrectomy
Maltese: Gastrektomija
English: No adjustment of the starting dose is required in patients ≥ 65 years old (see sections 4.8, 5.1 and 5.2).
Maltese: Mhux meħtieġ aġġustament tad-doża f'pazjenti ≥ 65 sena (ara sezzjonijiet 4.8, 5.1 u 5.2).
English: Hazard ratio for death, 0.68 (95% CI, 0.58-0.81) P<0.0001
Maltese: Prorporzjon ta' riskju tal-mewt, 0.68 (95% CI, 0.58-0.81) P<0.0001
English: The adverse drug reactions observed from the 533 treated patients with metastatic colorectal cancer in the placebo-controlled Phase III (RECOURSE) clinical trial and the 335 treated patients with metastatic gastric cancer in the placebo-controlled Phase III (TAGS) clinical trial, are shown in Table 5.
Maltese: Ir-reazzjonijiet avversi tal-mediċina osservati minn 533 pazjent ikkurati bil-kanċer kolorettali metastatiku fil-prova klinika kkontrollata minn plaċebo tal-Fażi III (RECOURSE) u t-335 pazjent ikkurati bil-kanċer gastriku metastatiku fil-prova klinika kkontrollata minn plaċebo tal-Fażi III (TAGS), huma murija f'Tabella 5.
English: Progression-free Survival Probability (%)
Maltese: Probabilità ta' Sopravivenza bla progressjoni (%)
English: Each film-coated tablet contains 120.980 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 120.980 mg ta' lactose monohydrate.
English: Lonsurf had no clinically relevant effect on QT/QTc prolongation compared with placebo in an open label study in patients with advanced solid tumours.
Maltese: Lonsurf ma kellux effett kliniku relevanti fuq il-prolongazzjoni QT/QTc meta mqabbel mal-plaċebo fi studju open label f'pazjenti b'tumuri solidi avvanzati.
English: - Printing ink: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), carnauba wax and talc.
Maltese: - Linka tal-istampar: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), xemgħa tal-karnawba u talc.
English: Other medicines and Lonsurf
Maltese: Mediċini oħra u Lonsurf
English: A higher exposure of Lonsurf was observed in moderate renal impairment (CrCl = 30 to 59 mL/min).
Maltese: Esponiment ogħla ta' Lonsurf kien osservat f'indeboliment moderat tal-kliewi (CrCl 30 sa 59 mL/min).
English: Primary cancer was gastric (71.0%) or gastroesophageal junction cancer (28.6%) or both (0.4%).
Maltese: Il-kanċer primarju kien gastriku (71.0%) jew kanċer tal-ġunzjoni esofagali (28.6%) jew it-tnejn (0.4%).
English: The primary site of disease was colon (62%) or rectum (38%).
Maltese: Is-siti prinċipali tal-marda kienu l-kolon (62%) jew ir-rektum (38%).
English: Anxiety Insomnia
Maltese: Ansjetà Insomnija
English: In nonclinical studies, trifluridine/tipiracil hydrochloride demonstrated antitumour activity against both 5-fluorouracil (5-FU) sensitive and resistant colorectal cancer cell lines.
Maltese: Fi studji mhux kliniċi, trifluridine/tipiracil hydrochloride wera attività kontra t-tumuri kontra l-linja taċ-ċelluli tal-kanċer kolorettali sensittivi u reżistenti għal 5-fluorouracil (5-FU).
English: After oral administration of Lonsurf with [14C]-tipiracil hydrochloride, at least 27% of the administered tipiracil hydrochloride was absorbed and 50% of the total radioactivity dose measured into faeces, suggestive of moderate gastrointestinal absorption of tipiracil hydrochloride.
Maltese: C]tipiracil hydrochloride, mill-anqas 27% ta' tipiracil hydrochloride mogħti kien assorbit u 50% tad-doża ta' radjuattività totali mkejla fl-ippurgar, li jissuġerixxi assorbiment gastrointestinali moderat ta' tipiracil hydrochloride.
English: Of the 533 patients in the RECOURSE study who received Lonsurf, 306 (57%) patients had normal renal function (CrCl ≥ 90 mL/min), 178 (33%) patients had mild renal impairment (CrCl 60 to 89 mL/min), and 47 (9%) had moderate renal impairment (CrCl 30 to 59 mL/min), with data missing for 2 patients.
Maltese: Mill-533 pazjent fl-istudju RECOURSE li rċevew Lonsurf, 306 (57%) pazjent kellhom funzjoni normali tal-kliewi (CrCl ≥ 90 mL/min), 178 (33%) pazjent kellhm indeboliment ħafif tal-kliewi (CrCl 60 sa 89 mL/min), u 47 (9%) kellhom indeboliment moderat tal-kliewi (CrCl 30 sa 59 mL/min), bid-data nieqsa ta' 2 pazjenti.
English: - Film coat: hypromellose, macrogol (8000), titanium dioxide (E171), and magnesium stearate.
Maltese: - Rita: hypromellose, macrogol (8000), titanium dioxide (E171), u magnesium stearate.
English: It is unknown whether Lonsurf may reduce the effectiveness of hormonal contraceptives.
Maltese: Mhuwiex magħruf jekk Lonsurf inaqqasx l-effettività tal-kontraċettivi ormonali.
English: Enteritis infectious Lung infection
Maltese: Enterite infettuża
English: • passing out (syncope)
Maltese: • ħass ħażin (sinkope)
English: Hazard ratio for death, 0.69 (95% CI, 0.56-0.85) P=0.0003 (1-sided) ; p =0.0006 (2-sided)
Maltese: Prorporzjon ta' riskju tal-mewt, 0.69 (95% CI, 0.56-0.85) P=0.0003 (naħa waħda) ; p =0.0006 (żewġ naħiet)
English: Following uptake into cancer cells, trifluridine, is phosphorylated by thymidine kinase, further metabolised in cells to a deoxyribonucleic acid DNA substrate, and incorporated directly into DNA, thereby interfering with DNA function to prevent cell proliferation.
Maltese: Wara l-assorbiment fiċ-ċelluli tal-kanċer, trifluridine huwa fosforilat minn thymidine kinase, metaboliżat aktar f'ċelluli għal sottostrat ta' deoxyribonucleic acid DNA, u inkorporat direttament fidDNA, għaldaqstant jinterferixxi mal-funzjoni tad-DNA sabiex jipprevjeni l-proliferazzjoni taċ-ċelluli.
English: Paraesthesia Burning sensation Lethargy Dizziness Headache
Maltese: Paresteżija Sensazzjoni ta' ħruq Letarġija
English: • Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to
Maltese: • Indeboliment ħafif tal-kliewi (CrCl 60 sa 89 mL/min) jew indeboliment moderat tal-kliewi
English: Lonsurf plus BSC (N=534)
Maltese: Lonsurf kif ukoll BSC (N=534)
English: Lonsurf caused an increase in the incidence of gastrointestinal toxicities including nausea, vomiting and diarrhoea.
Maltese: Lonsurf ikkawża żieda fl-inċidenza ta' effetti tossiċi gastrointestinali inkluż id-dardir, rimettar u dijarea.
English: Placebo plus BSC (N=266)
Maltese: Plaċebo kif ukoll BSC (N=266)
English: The OS and PFS benefit was observed consistently, in all randomization strata and across most pre specified subgroups, including sex, age (< 65; ≥ 65 years), ethnic origin, ECOG PS, prior ramucirumab treatment, prior irinotecan treatment, number of prior regimens (2; 3; ≥ 4), previous gastrectomy, primary tumour site (gastric; gastroesophageal junction) and HER2 status.
Maltese: Il-benefiċċju tal-OS u PFS ġie osservat b'mod konsistenti, fl-istrati tar-randomizzazzjoni kollha u filbiċċa l-kbira tas-sottogruppi speċifikati minn qabel, inkluż sess, età (< 65; ≥ 65 sena), oriġini etnika, PS ta' ECOG, kura preċedenti b'ramucirumab, kura preċedenti b'irinotecan, numru ta' korsijiet preċedenti (2; 3; ≥ 4), gastrektomija preċedenti, sit tat-tumur primarju (gastriku; ġunzjoni gastroesofagali) u status tal-HER2.
English: Table 6 - Efficacy results from the Phase III (RECOURSE) clinical trial in patients with metastatic colorectal cancer
Maltese: Tabella 6 - Riżultati ta' effikaċja mill-prova klinika tal-Fażi III (RECOURSE) f'pazjenti bilkanċer kolorettali metastatiku