FrancophonIA/ELRC3.0 huggingface dataset:
English: • CTCAE* non-haematologic Grade 3 or Grade 4 adverse reaction; except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or diarrhoea responsive to antidiarrhoeal medicinal products
Maltese: • CTCAE* reazzjoni avversa mhux ematoloġika tal-Grad 3 jew tal-Grad 4; minbarra dardir u/jew rimettar tal-Grad 3 ikkontrollat minn terapija antiemetika jew dijarea li tirrispondi għal prodotti mediċinali ta' kontra d-dijareja.
English: Palmar-plantar erythrodysaesthesia syndromec
Maltese: Sindromu ta' eritrodiżestiżja palmariplantari c
English: Lonsurf caused an increase in the incidence of myelosuppression including anaemia, neutropenia, leukopenia, and thrombocytopenia.
Maltese: Lonsurf ikkawża żieda fl-inċidenza tal-majelosuppressjoni inkluż anemija, newtropenija, lewkopenija, u tromboċitopenija.
English: There is limited data in Lonsurf treated patients aged 75 years and above (87 patients (10%) in pooled data of the RECOURSE and TAGS studies, of which 2 patients were 85 years or older).
Maltese: Hemm data limitata f'pazjenti kkurati b'Lonsurf li għandhom 75 sena u aktar (87 pazjent (10%) fid data miġbura tal-istudji RECOURSE u TAGS, li minnhom 2 pazjenti kellhom 85 sena jew aktar).
English: Placebo plus BSC (N=170)
Maltese: Plaċebo kif ukoll BSC (N=170)
English: Lonsurf 20 mg/8.19 mg tablet
Maltese: Lonsurf 20 mg/8.19 mg pillola
English: Tests and checks
Maltese: Testijiet u verifiki
English: Thus it is unlikely to cause an interaction with other medicinal products, at recommended doses, due to inhibition of OCT2 and MATE1.
Maltese: Għaldaqstant mhuwiex probabbli li jikkawża interazzjoni ma' prodotti mediċinali oħra, fiddożi rakkomandati, minħabba inibizzjoni ta' OCT2 u MATE1.
English: Therefore, when using antiviral medicinal products that are human thymidine kinase substrates, monitor for possible decreased efficacy of the antiviral medicinal product, and consider switching to an alternative antiviral medicinal product that is not a human thymidine kinase substrate, such as lamivudine, didanosine and abacavir (see section 5.1).
Maltese: Għaldaqstant, waqt l-użu ta' prodotti mediċinali antivirali li huma sottostrati ta' thymidine kinase talbnedmin, immonitorja għat-tnaqqis possibbli fl-effikaċja tal-prodott mediċinali antivirali, u kkunsidra l-bidla għal prodott mediċinali antivirali alternattiv li mhuwiex sottostrat ta' thymidine kinase talbnedmin bħal lamivudine, didanosine u abacavir (ara sezzjoni 5.1).
English: The median OS was 5.7 months (95% CI: 4.8, 6.2) for the Lonsurf group versus 3.6 months (95% CI: 3.1, 4.1) for the placebo group; with 1-year survival rates of 21.2% and 13.0%, respectively.
Maltese: L-OS medjana kienet 5.7 xhur (95% CI: 4.8, 6.2) għall-grupp ta' Lonsurf kontra 3.6 xhur (95% CI: 3.1, 4.1) għall-grupp tal-plaċebo; b'rati ta' sopravivenza ta' sena ta' 21.2 % u 13.0 %, rispettivament.
English: Lonsurf on overall survival was similar in patients <65 years and ≥65 years of age.
Maltese: Leffett ta' Lonsurf fuq is-sopravivenza globali kien simili f'pazjenti <65 sena u ≥65 sena.
English: Protein total decreased
Maltese: Tnaqqis fil-livelli tal-proteini totali
English: The median time to PS ≥ 2 for the Lonsurf group and placebo group was 5.7 months and 4.0 months, respectively, with a hazard ratio of 0.66 (95% CI: [0.56, 0.78]), p < 0.0001.
Maltese: Iż-żmien medjan għal PS ≥ 2 għall-grupp Lonsurf u l-grupp plaċebo kien 5.7 xhur u 4.0 xhur, rispettivament, bi proporzjon ta' riskju ta' 0.66 (95% CI: [0.56, 0.78]), p < 0.0001.
English: Of the 507 randomised patients, the median age was 63 years, 73% were male, 70% were White, 16% were Asian, and <1% were Black/African American, and all patients had baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Maltese: Mill-507 pazjenti randomizzati, l-età medjana kienet ta' 63 sena, 73 % kienu rġiel, 70 % kienu Bojod, 16 % kienu Asjatiċi, u <1 % kienu Suwed/Amerikani Afrikani, u l-pazjenti kollha kellhom Status ta' Prestazzjoni (PS) tal-Eastern Cooperative Oncology Group (ECOG) ta' 0 jew 1.
English: Lonsurf plus BSC (N=337)
Maltese: Lonsurf kif ukoll BSC (N=337)
English: • changes in your heart trace (ECG - electrocardiogram)
Maltese: • bidliet fir-rittmu tal-qalb (ECG - elettrokardjogram)
English: There is limited data on Lonsurf in Black/African American patients but there is no biological rationale to expect any difference between this subgroup and the overall population.
Maltese: Hemm data limitata dwar Lonsurf f'pazjenti Suwed/Afrikani Amerikani imma ma hemmx raġuni bijoloġika li wieħed jistenna kwalunkwe differenza bejn dan is-sottogrupp u l-popolazzjoni ġenerali.
English: The most common adverse drug reactions (≥ 2%) in patients receiving Lonsurf that resulted in treatment discontinuation, dose reduction, dose delay, or dose interruption were neutropenia, anaemia, leukopenia, fatigue, thrombocytopenia, nausea and diarrhoea.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina komuni (≥ 2%) f'pazjenti li jirċievu Lonsurf li rriżultaw fit-twaqqif tal-kura, tnaqqis tad-doża, dewmien tad-doża jew interruzzjoni tad-doża kienu newtropenija, anemija, lewkopenija, għejja, tromboċitopenja, dardir u dijarea.
English: Tipiracil hydrochloride was the major component and 6-hydroxymethyluracil was the major metabolite consistently in human plasma, urine, and faeces.
Maltese: Tipiracil hydrochloride kien il-komponent ewlieni u 6-hydroxymethyluracil kien il-metabolit ewlieni konsistement fil-plażma tal-bnedmin, awrina u ppurgar.
English: The median time to deterioration of ECOG performance status to ≥2 was 4.3 months for the Lonsurf group versus 2.3 months for the placebo group with HR of 0.69 (95% CI: 0.562, 0.854), p-value = 0.0005.
Maltese: Iż-żmien medjan għad-deterjorazzjni tal-istatus tal-prestazzjoni ta' ECOG għal ≥2 kien 4.3 xhur għallgrupp ta' Lonsurf kontra 2.3 xhur għall-grupp tal-plaċebo b'HR ta' 0.69 (95% CI: 0.562, 0.854), valur p = 0.0005.
English: Level 3 dose reduction: From 25 mg/m2 to 20 mg/m2 20 mg/m
Maltese: Tnaqqis fid-doża ta' livell 3: Minn 25 mg/m sa 20 mg/m20 mg/m a
English: The absorbed trifluridine was metabolised, and excreted into urine as FTY and trifluridine glucuronide isomers.
Maltese: It-trifluridine assorbit kien metabolizzat, u eliminat fl-awrina bħala FTY u iżomeri ta' trifluridine glucuronide.
English: - Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172) and magnesium stearate.
Maltese: - Rita: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172) u magnesium stearate.
English: Table 7 - Efficacy results from the Phase III (TAGS) clinical trial in patients with metastatic gastric cancer
Maltese: Tabella 7 - Riżultati ta' effikaċja mill-prova klinika tal-Fażi III (TAGS) f'pazjenti bil-kanċer gastriku metastatiku
English: • viral infection
Maltese: • infezzjonijiet virali
English: Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
Maltese: Lonsurf huwa indikat bħala monoterapija għall-kura ta' pazjenti adulti li jbatu mill-kanċer kolorettali metastatiku (CRC) li kienu kkurati qabel, jew mhumiex meqjusa kandidati għal, b'terapiji disponibbli inkluż kimoterapiji bbażati fuq fluoropyrimidine, oxaliplatin u irinotecan, aġenti kontra l-VEGF, u aġenti kontra l-EGFR.
English: 50a a At a total daily dose of 50 mg, patients should take 1 x 20 mg/8.19 mg tablet in the morning and 2 x 15 mg/6.14 mg tablets in the evening.
Maltese: Wara doża totali tal-jum ta' 50 mg, il-pazjenti għandhom jieħdu 1 x 20 mg/8.19 mg pillola u 2 x 15 mg/6.14 mg pilloli filgħaxija.
English: a Kaplan-Meier estimates b Methodology of Brookmeyer and Crowley c Stratified log-rank test (strata: region, ECOG status at baseline, prior ramucirumab treatment)
Maltese: Test stratifikat log-rank (strata: reġjun, status ECOG fil-linja bażi, kura preċedenti b'ramucirumab)
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' intolleranza tal-galactose, id-defiċjenza ta' lactase totali jew malassorbiment tal-glucose-galactose ma għandhomx jieħdu dan il-prodott mediċinali.
English: • Lonsurf 20 mg/8.19 mg is a pale red, biconvex, round, film-coated tablet, printed with “20” on one side and “102” and “20 mg” on the other side in grey ink.
Maltese: • Lonsurf 20 mg/8.19 mg hija ħamra ċara, mżaqqa miż-żewġ naħar, tonda, miksija b'rita, b''20' stampata fuq naħa waħda, u ‘102' u ‘20 mg' fuq in-naħa l-oħra, b'linka griża.
English: The target organs identified were the lymphatic and haematopoietic systems and the gastrointestinal tract.
Maltese: L-organi fil-mira identifikati kienu s-sistemi limfatiċi u ematopojtiċi u l-passaġġ gastrointestinali.
English: <0.0001 (1-sided and 2-sided)
Maltese: <0.0001 (naħa waħda u żewġ naħiet)
English: < 0.0001 (1-sided and 2-sided)
Maltese: < 0.0001 (naħa waħda u żewġ naħiet)
English: PFS was significantly improved in patients receiving Lonsurf plus BSC (hazard ratio: 0.48; 95% CI [0.41 to 0.57]; p < 0.0001 (see Table 6, Figure 1 and Figure 2).
Maltese: PFS ittejbet b'mod sinifikanti f'pazjenti li qed jirċievu Lonsurf kif ukoll BSC (proporzjon ta' riskju: 0.48; 95% CI [0.41 sa 0.57]; p < 0.0001 (ara Tabella 6, Figura 1 u Figura 2).
English: Dysgeusia Neuropathy peripheral
Maltese: Disgewsja Newropatija periferali
English: Titanium dioxide (E171) Iron oxide red (E172) Magnesium stearate
Maltese: Titanium dioxide (E171) Iron oxide red (E172)
English: The OS and PFS benefit was observed consistently, in all relevant pre-specified subgroups, including race, geographic region, age (< 65; ≥ 65), sex, ECOG PS, KRAS status, time since diagnosis of first metastasis, number of metastatic sites, and primary tumour site.
Maltese: L-OS u l-benefiċċju PFS kienu osservati b'mod konsistenti, fis-sottogruppi speċifikati minn qabel relevanti kollha, inkluż ir-razza, ir-reġjun ġeografiku, età (< 65; ≥ 65), sess, PS tal-ECOG, status KRAS, tul taż-żmien mid-dijanjożi tal-ewwel metastasi, numru ta' siti metastatiċi, u sit ewlieni tattumur.
English: Other minor metabolites, 5-carboxyuracil and 5-carboxy-2'-deoxyuridine, were detected, but those levels in plasma and urine were at low or trace levels.
Maltese: Metaboliti minuri oħra, 5-carboxyuracil u 5-carboxy-2'deoxyuridine, kienu osservati, imma dawk il-livelli fil-plażma u l-awrina kienu f'livelli baxxi jew ta' traċċa.
English: Metastatic colorectal cancer
Maltese: Kanċer kolerettali metastatiku
English: Each tablet contains 20 mg trifluridine and 8.19 mg tipiracil.
Maltese: Kull pillola fiha 20 mg trifluridine u 8.19 mg tipiracil.
English: 59 mL/min)
Maltese: (CrCl 30 sa 59 mL/min)
English: • Lonsurf 15 mg/6.14 mg is a white, biconvex, round, film-coated tablet, printed with “15” on one side and “102” and “15 mg” on the other side in grey ink.
Maltese: • Lonsurf 15 mg/6.14 mg hija bajda, mżaqqa miż-żewġ naħat, tonda, miksija b'rita, b''15' stampata fuq naħa waħda, u ‘102' u ‘15 mg' fuq in-naħa l-oħra, b'linka griża.
English: Table 5 - Adverse drug reactions reported in clinical trials in patients treated with Lonsurf System Organ Class (MedDRA)a
Maltese: Tabella 5 - Reazzjonijiet avversi tal-mediċina rrapportati fil-provi kliniċi f'pazjenti kkurati b'Lonsurf
English: Tumor assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were performed by the investigator/local radiologist every 8 weeks.
Maltese: Saru valutazzjonijiet tat-tumur, skont il-Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST), verżjoni 1.1, millinvestigatur/radjoloġist lokali kull 8 ġimgħat.
English: The dosage is calculated according to body surface area (BSA) (see Table 1).
Maltese: Id-dożaġġ huwa kkalkolat skont l-erja tas-superfiċje tal-ġisem (body surface area, BSA) (ara Tabella 1).
English: Blood lactate dehydrogenase increased
Maltese: Żieda ta' lactate dehydrogenase fiddemm
English: Each pack contains 20, 40 or 60 film-coated tablets.
Maltese: Kull pakkett fih 20, 40 jew 60 pillola miksija b'rita.
English: • bloating, passing gas, indigestion
Maltese: • nefħa, gass, indiġestjoni
English: • Pulmonary embolism (uncommon): blood clots in lungs.
Maltese: • Emboliżmu pulmonari (mhux komuni): koaguli tad-demm fil-pulmun.
English: The primary efficacy endpoint was overall survival (OS), and supportive efficacy endpoints were progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR).
Maltese: Il-punt aħħari primarju ta' effikaċja kien sopravivenza totali (overall survival, OS) u l-punti aħħarija sekondarji ta' effikaċja kienu sopravivenza bla progressjoni (progression-free survival, PFS), rata ta' rispons globali (overall response rate, ORR) u rata għallkontroll tal-mard (disease response rate, DCR).
English: • shingles (pain and vesicular rash on skin over nerve tracts affected by nerve inflammation from herpes zoster virus)
Maltese: • ħruq ta' Sant' Antnin (uġigħ u raxx vesikulari fil-ġilda fuq is-sistemi tan-nervaturi affetwati minn infjammazzjoni tan-nervaturi mill-virus tal-herpes zoster)
English: The Lonsurf survival benefit was maintained after adjusting for all significant prognostic factors, namely, time since diagnosis of first metastasis, ECOG PS and number of metastatic sites (hazard ratio: 0.69; 95% CI [0.58 to 0.81]).
Maltese: Il-benefiċċju ta' sopravivenza ta' Lonsurf kien miżmum wara l-aġġustament għall-fatturi pronostiċi sinfikattivi kollha, primarjament, it-tul taż-żmien mid-dijanjożi tal-ewwel metastasi, PS talECOG u numru ta' siti metastatiċi (proporzjon ta' riskju: 0.69; 95% CI [0.58 sa 0.81]).
English: • The active substances are trifluridine and tipiracil.
Maltese: • Is-sustanzi attivi huma trifluridine u tipiracil.
English: In vitro studies indicated that trifluridine, tipiracil hydrochloride and 5-[trifluoromethyl] uracil (FTY) did not inhibit the activity of human cytochrome P450 (CYP) isoforms.
Maltese: Studji in vitro indikaw li trifluridine, tipiracil hydrochloride u 5-[trifluoromethyl] uracil (FTY) ma inibixxux l-attività tal-iżoformi taċ-ċitokromu P450 (CYP) tal-bnedmin.
English: Pancytopenia Granulocytopenia Monocytopenia Erythropenia Leukocytosis Monocytosis
Maltese: Panċitopenija Granuloċitopenija Monoċitopenija Eritropenija Lewkoċitożi Monoċitożi
English: Following a single dose of Lonsurf (35 mg/m2) in patients with advanced solid tumours, the apparent volume of distribution (Vd/F) for trifluridine and tipiracil hydrochloride was 21 L and 333 L, respectively.
Maltese: Wara doża waħda ta' Lonsurf (35 mg/m2) f'pazjenti b'tumuri solidi avvanzati, il-volum apparenti tad-distribuzzjoni (Vd/F) ta' trifluridine u tipiracil hydrochloride kienu madwar 21 L u 333 L, rispettivament.
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/6.14 mg tablets trifluridine/tipiracil
Maltese: TAL-PRODOTT MEDIĊINALI Lonsurf 15-il mg/6.14 mg pilloli trifluridine/tipiracil
English: • Trifluridine stops the growth of cancer cells.
Maltese: • Trifluridine iwaqqaf it-tkabbir taċ-ċelluli tal-kanċer.
English: For low albumin values ranging from 2.2 to 3.5 g/dL, the corresponding clearance values range from 4.2 to 3.1 L/h.
Maltese: Għal valuri baxxi tal-albumina minn 2.2 sa 3.5 g/dL, il-valuri tat-tneħħija korrispondenti huma minn 4.2 sa 3.1 L/h.
English: Tel: +34 91 748 96 30
Maltese: Laboratorios Servier S.L. Tel: +34 91 748 96 30
English: NAME OF THE MEDICINAL PRODUCT Lonsurf 20 mg/8.19 mg tablets trifluridine/tipiracil
Maltese: TAL-PRODOTT MEDIĊINALI Lonsurf 20 mg/8.19 mg pilloli trifluridine/tipiracil
English: After single oral administration of Lonsurf with [14C]-tipiracil hydrochloride, recovered radioactivity was 77% of the dose, which consisted of 27% urinary excretion and 50% faecal excretion.
Maltese: C]-tipiracil hydrochloride,ir-radjoattività rkuprata kienet ta' 77% tad-doża, li kkonsistiet minn 27% ta' eliminazzjoni tal-awrina u 50% eliminazzjoni tal-ippurgar.
English: There is no relevant use of Lonsurf in the paediatric population for the indications of metastatic colorectal cancer and metastatic gastric cancer.
Maltese: Ma hemmx użu relevanti ta' Lonsurf fil-popolazzjoni pedjatrika għall-indikazzjonijiet tal-kanċer kolorettali metastatiku u kanċer gastriku metastatiku.
English: Each tablet contains 15 mg trifluridine and 6.14 mg tipiracil
Maltese: Kull pillola fiha 15-il mg trifluridine u 6.14 mg tipiracil.
English: OS appeared more favourable in the high AUC group compared to the low AUC group (median OS of 9.3 vs. 8.1 months, respectively).
Maltese: L-OS deher aktar favorevoli fil-grupp tal-AUC għoli meta mqabbel mal-grupp tal-AUC baxx (OS medjan ta' 9.3 kontra 8.1 xhur, rispettivament)
English: • low levels of albumin or total protein in the blood
Maltese: • livelli baxxi ta' albumina jew proteina totali fid-demm
English: In the pharmacokinetic (PK) analyses of the multiple dose administration of Lonsurf (35 mg/m2/dose, twice daily for 5 days a week with 2 days rest for 2 weeks followed by a 14-day rest, repeated every 4 weeks), trifluridine area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) was approximately 3-fold higher and maximum concentration (Cmax) was approximately 2-fold higher after multiple dose administration (Day 12 of Cycle 1) of Lonsurf than after single-dose (Day 1 of Cycle 1).
Maltese: Fl-analiżi farmakokinetiċi (PK) fl-għoti ta' dożi multipli ta' Lonsurf (35 mg/m2/doża, darbtejn kuljum għal 5 ijiem fil-ġimgħa b'jumejn mistrieħ għal ġimagħtejn, segwita minn 14-il jum mistrieħ, ripetuta kull 4 ġimgħat), l-erja ta' trifluridine taħt il-kurva tal-konċentrazzjoni fil-ħin mill-ħin 0 sal-aħħar konċentrazzjoni li tista' titkejjel (AUC0-last) kienet bejn wieħed u ieħor 3-darbiet ogħla u lkonċentrazzjoni massima (Cmax) kienet bejn wieħed u ieħor darbtejn ogħla wara l-għoti ta' dożi multipli (Jum 12 taċ-Ċiklu 1) ta' Lonsurf milli wara doża waħda (Jum 1 taċ-Ċiklu 1).
English: • high blood sugar (hyperglycaemia), increased salt, urea, creatinine and potassium in your blood
Maltese: • livell għoli ta' zokkor fid-demm (ipergliċemija), żieda fil-melħ, urea, krejatinina u potassium fid demm tiegħek
English: PFS was significantly improved in patients receiving Lonsurf plus BSC compared to placebo plus BSC (HR of 0.57; 95% CI [0.47 to 0.70]; p < 0.0001 (see Table 7, Figure 3 and Figure 4).
Maltese: Il-PFS tjiebet b'mod sinifikanti fil-pazjenti li rċivew Lonsurf kif ukoll BSC meta mqabbel ma' plaċebo kif ukoll BSC (HR ta' 0.57; 95% CI [0.47 sa 0.70]; p < 0.0001 (ara Tabella 7, Figura 3 u Figura 4).
English: In total, 800 patients were randomised 2:1 to receive Lonsurf (N = 534) plus best supportive care (BSC) or matching placebo (N = 266) plus BSC. Lonsurf dosing was based on BSA with a starting dose of 35 mg/m2/dose.
Maltese: B'kollox, 800 pazjent kien randomizzati 2:1 sabiex jirċievu Lonsurf (N = 534) kif ukoll l-aħjar kura ta' appoġġ (best supportive care, BSC) jew plaċebo li jaqbel (N = 266) kif ukoll BSC.
English: Septic shockb
Maltese: Xokk settiku b
English: The effect was also maintained in regorafenib-naive patients (hazard ratio: 0.69, 95% CI [0.57 to 0.83]).
Maltese: L-effett kien miżmum ukoll fil-pazjenti li qatt ma ħadu regorafenib (proporzjon ta' riskju: 0.69, 95% CI [0.57 sa 0.83]).
English: Lonsurf 15 mg/6.14 mg film-coated tablets Lonsurf 20 mg/8.19 mg film-coated tablets trifluridine/tipiracil
Maltese: Lonsurf 15-il mg/6.14 mg pilloli miksijin b'rita Lonsurf 20 mg/8.19 mg pilloli miksijin b'rita trifluridine/tipiracil
English: Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting and during therapy (see section 4.8).
Maltese: Huwa rrakkomandat monitoraġġ tal-proteinurija permezz ta' analiżi tal-awrina bid-dipstick qabel ilbidu ta' u waqt it-terapija (ara sezzjoni 4.8).
English: The clinical efficacy and safety of Lonsurf were evaluated in an international, randomised, doubleblind, placebo-controlled Phase III study (RECOURSE) in patients with previously treated metastatic colorectal cancer.
Maltese: L-effikaċja u sigurtà klinika ta' Lonsurf kienu evalwati fi studju tal-Fazi III (RECOURSE) internazzjonali, randomizzat, double-blind, ikkontrollat minn plaċebo f'pazjenti b'kanċer kolorettali metastatiku kkurat qabel.
English: The ORR (complete response + partial response) was not significantly higher in patients treated with Lonsurf (4.5% vs 2.1 %, p-value = 0.2833) but the DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Lonsurf (44.1% vs 14.5%, p < 0.0001).
Maltese: L-ORR (rispons sħiħ + rispons parzjali) ma kienx ogħla b'mod sinifikanti f'pazjent kkurati b'Lonsurf (4.5% vs 2.1 %, valur p = 0.2833) iżda d-DCR (rispons sħiħ jew rispons parzjali jew marda stabbli) kien ogħla b'mod sinifikanti f'pazjenti kkurati b'Lonsurf (44.1% vs 14.5%, p < 0.0001).
English: The tablet is a pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with ‘20' on one side, and ‘102' and ‘20 mg' on the other side, in grey ink.
Maltese: Il-pillola miksija b'rita hija ħamra ċara, mżaqqa miż-żewġ naħat, tonda, b'dijametru ta' 7.6 mm u ħxuna ta' 3.2 mm, b''20' stampata fuq naħa waħda, u ‘102' u ‘20 mg' fuq in-naħa l-oħra, b'linka griża.
English: Serious infections have been reported following treatment with Lonsurf (see section 4.8).
Maltese: Ġew irrapportati infezzjonijiet serji wara l-kura b'Lonsurf (ara sezzjoni 4.8).
English: Caution is required when using medicinal products that are human thymidine kinase substrates, e.g., zidovudine.
Maltese: Il-kawtela hija meħtieġa waqt l-użu ta' prodotti mediċinali li huma sottostrati ta' thymidine kinase talbnedmin, eż., zidovudine.
English: In vitro interaction studies
Maltese: Studji dwar l-interazzjoni in-vitro
English: This 4 week period is called a ‘cycle.'
Maltese: Dan il-perjodu ta' 4 ġimgħat jissejjaħ ‘ċiklu'.
English: • Neutropenia (very common), febrile neutropenia (common) and septic shock (uncommon).
Maltese: • Newtropenija (komuni ħafna), newtropenija bid-deni (komuni) u xokk settiku (mhux komuni).
English: Plasma protein binding of tipiracil hydrochloride was below 8%.
Maltese: It-twaħħil tal-proteina fil-plażma ta' tipiracil hydrochloride kien taħt 8%.
English: In the Phase III clinical trials, treatment-related infections occurred more frequently in Lonsurf-treated patients (5.8%) compared to those receiving placebo (1.8%).
Maltese: Fil-provi kliniċi tal-Fażi III, infezzjonijiet relatati mal-kura seħħew b'mod aktar frekwenti f'pazjenti kkurati b'Lonsurf (5.8%) meta mqabbla ma' dawk li rċevew plaċebo (1.8%).
English: Marketing Authorisation Holder Les Laboratoires Servier 50 rue Carnot
Maltese: 50 rue Carnot
English: • Dose reductions are permitted to a minimum dose of 20 mg/m2/dose twice daily.
Maltese: • It-tnaqqis fid-doża huwa permess sa doża minima ta' 20 mg/m 2/doża darbtejn kuljum.
English: Among these patients, the OS benefit with Lonsurf was maintained (hazard ratio: 0.75, 95% CI [0.59 to 0.94]).
Maltese: Fost dawn il-pazjenti, il-benefiċċju tal-OS b'Lonsurf kien miżmum (proporzjon ta' riskju: 0.75, 95% CI [0.59 sa 0.94]).
English: Half-life time (t1/2) and the accumulation ratio of trifluridine and tipiracil hydrochloride were similar between the moderate, mild and normal hepatic function patients.
Maltese: Il-ħin tan-nofs ħajja (t1/2) u l-propozjon ta' akkumulazzjoni ta' trifluridine u tipiracil hydrochloride kienu simili bejn il-pazjenti b'funzjoni tal-fwied moderata, ħafifa u normali.
English: The mean t1/2 values for tipiracil hydrochloride on Day 1 of Cycle 1 and on Day 12 of Cycle 1 were 2.1 hours and 2.4 hours, respectively.
Maltese: Il-valuri t1/2 medji ta' tipiracil hydrochloride fil-Jum 1taċ-Ċiklu 1 u filJum 12 taċ-Ċiklu 1 kienu ta' 2.1 sigħat u 2.4 sigħat, rispettivament.
English: Lonsurf comes in two strengths.
Maltese: X'inhu Lonsurf u gћalxiex jintuża 2.
English: s r.o.
Maltese: P<0.