FrancophonIA/ELRC3.0 huggingface dataset:
English: At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).
Maltese: Fl-aħħar tal-istudju, 9% tal-pazjenti li kienu ħadu Efient mietu minħabba kawżi kardjovaskulari jew kellhom attakk tal-qalb jew puplesija (643 minn 6,813) meta mqabbla ma' 11% tal-pazjenti li kienu ħadu clopidogrel (781 minn 6,795).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Efient on 25 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Efient fil-25 ta' Frar 2009.
English: Other information about Efient
Maltese: Informazzjoni oħra dwar Efient:
English: In one main study Efient, given as a 60-mg starting dose followed by 10-mg ‘maintenance' doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin.
Maltese: Fi studju ewlieni Efient, mogħti bħala doża tal-bidu ta' 60- mg segwita minn dożi ta' ‘manteniment' ta' 10-mg, tqabbel ma' clopidogrel (inibitur ieħor tal-aggregazzjoni tal-pjatsrini), biż-żewġ mediċini jittieħdu flimkien mal-aspirina.
English: What is the risk associated with Efient?
Maltese: X'inhu r-riskju assoċjat ma'Efient?
English: This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day.
Maltese: Imbagħad din tiġi segwita b'doża ta' 10 mg meħuda darba kuljum, ħlief f'pazjenti li jiżnu inqas minn 60 kg, li għandhom jieħdu 5 mg darba kuljum.
English: Why has Efient been approved?
Maltese: Għaliex ġie approvat Efient?
English: What benefit has Efient shown during the studies?
Maltese: Liema benefiċċju wera Efient waqt l-istudji mwettqa?
English: The CHMP decided that Efient's benefits are greater than its risks, when given together with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.
Maltese: Is-CHMP ddeċieda li l-benefiċċji ta' Efient huma ikbar mir-riskji tiegħu, meta jingħata mal-aspirina, għall-prevenzjoni ta' episodji aterotrombotiċi f'pazjenti b'sindromu koronarju akut li għaddejjin minn intervent koronarju minn ġol-ġilda primarju jew ittardjat.
English: It includes unstable angina (a severe type of chest pain) and heart attack.
Maltese: Tinkuldi l-anġina mhux stabbli (tip ta' wġigħ gravi fis-sider) u l-attakki tal-qalb.
English: Efient is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention.
Maltese: Efient jittieħed flimkien mal-aspirina għall-prevenzjoni ta' episodji aterotrombotiċi (problemi kkawżati minn emboli tad-demm u twebbis tal-arterji) f'pazjenti b'sindromu koronarju akut li jkunu qegħdin jagħmlu intervent koronarju minn ġol-ġilda.
English: Efient was more effective than clopidogrel at reducing the total number of cardiovascular deaths, heart attacks or strokes.
Maltese: Efient kien aktar effettiv minn clopidogrel fit-tnaqqis tan-numru totali ta' mwiet għal raġunijiet kardjovaskulari, attakki tal-qalb u puplesiji.
English: The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention.
Maltese: L-istudju kien jinvolvi kważi 14,000 adult b'sindromu koronarju akut li kien ser ikollhom intervent koronarju minn ġol-ġilda.
English: What is Efient?
Maltese: X'inhu Efient?
English: How has Efient been studied?
Maltese: Kif ġie studjat Efient?
English: Microsatellite instability (MSI)
Maltese: Instabilità mikrosatellitari (microsatellite instability - MSI)
English: Date of renewal: 19 November 2015
Maltese: Data tal-aħħar tiġdid: 19 ta' Novembru 2015
English: 3741 LM Baarn The Netherlands
Maltese: 3741 LM Baarn L-Olanda
English: 126 capsules
Maltese: 126 kapsula
English: Rare / Very rare
Maltese: Rari / Rari ħafna
English: Grade 2b,c Any occurrence
Maltese: Grad 2b,c Kull każ
English: Haemoglobin ≥6.2 mmol/l
Maltese: Emoglobina ≥6.2 mmol/l
English: System Organ Classa
Maltese: Sistema talKlassifika talOrgania
English: Lactose (one type of sugar).
Maltese: Lactose (tip ta' zokkor).
English: 42 capsules
Maltese: 42 kapsula
English: Standard dosea: 25 mg/m2
Maltese: Doża standard dosea: 25 mg/m2
English: 2132 WT Hoofddorp The Netherlands
Maltese: 2132 WT Hoofddorp L-Olanda
English: Median (Range) ≥65, n (%)
Maltese: Medjan (Firxa) ≥65, n (%)
English: Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Ireland
Maltese: Millmount Healthcare Limited Block7, City North Business Campus, Stamullen Co.
English: Linearity/non-linearity
Maltese: Linejarità/Nuqqas ta' linejarità
English: There were no clinically relevant differences in safety between males (N=382) and females (N=139) in the FLAGS study.
Maltese: Ma kien hemm ebda differenzi klinikament rilevanti fis-sigurtà ta' bejn irġiel (N=382) u nisa (N=139) fl-istudju FLAGS.
English: Each hard capsule contains 70.2 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 70.2 mg lactose monohydrate.
English: CYP2A6 inhibitors
Maltese: Impedituri ta' CYP2A6
English: Oteracil, gimeracil, 5-FU, and tegafur were 8.4%, 32.2%, 18.4%, and 52.3% protein bound, respectively.
Maltese: Oteracil, gimeracil, 5-FU, u tegafur kienu 8.4%, 32.2%, 18.4%, u 52.3% marbuta ma' proteini, rispettivament.
English: • Contraindications for cisplatin; refer to the cisplatin SmPC.
Maltese: • Kontraindikazzjonijiet għal cisplatin; irreferi għal SmPC ta' cisplatin.
English: The cycles are repeated.
Maltese: Iċ-ċikli jiġu ripetuti.
English: Hepatitis B reactivation
Maltese: Riattivazzjoni ta' epatite B
English: Each hard capsule contains 93.6 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 93.6 mg lactose monohydrate.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 14 ta' Mar 2011
English: ECOG Performance Status, n (%)
Maltese: Stat ta' Prestazzjoni ECOG, n (%)
English: Black or African American Asian
Maltese: Amerikan Iswed jew Afrikan Ażjatiku
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Nordic Group B.V., Siriusdreef 41, 2132 WT Hoofddorp, The Netherlands 12.
Maltese: Nordic Group B.V., Siriusdreef 41 , 2132 WT Hoofddorp, L-Olanda 12.
English: Patients with renal impairment (see sections 4.2, 4.3, 4.4, and 5.2)
Maltese: Pazjenti b'indeboliment tal-kliewi (ara sezzjonijiet 4.2, 4.3, 4.4, u 5.2)
English: There have been some case reports of foetal abnormalities.
Maltese: Kien hemm xi każijiet rapportati ta' abnormalitajiet fetali.
English: Ink: red iron oxide (E172), yellow iron oxide (E172), Indigo carmine (E132), carnauba wax, bleached shellac, glyceryl monooleate
Maltese: Linka: red iron oxide (E172), yellow iron oxide (E172), Indigo carmine (E132), carnauba wax, bleached shellac, glyceryl monooleate
English: • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Maltese: • Nuqqas ta' dihydropyrimidine dehydrogenase (DPD) magħruf.
English: Disseminated intravascular coagulation
Maltese: Koagulazzjoni intravaskulari mifruxa
English: American Indian or Alaska Native Other
Maltese: Amerikan Indjan jew ta' Oriġini mill-Alaska
English: Liver function test abnormal, gamma glutamyltransferase increased
Maltese: Test tal-funzjoni tal-fwied mhux normali, żieda fil-gamma glutamyltransferase,
English: Manufacturer Nordic Pharma Tolweg 15
Maltese: Manifattur Nordic Pharma Tolweg 15
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA < PC:
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM < PC:
English: Standard dose (mg/m2)
Maltese: Doża standard (mg/m2)
English: Table 1: Standard dose and dose reductions allowed for Teysuno and/or for cisplatin
Maltese: Tabella 1: Doża standard u tnaqqis fid-doża permessi għal Teysuno u/jew għal cisplatin
English: Table 9: Overall survival and progression-free survival in FLAGS
Maltese: Tabella 9: Sopravivenza globali u sopravivenza mingħajr progressjoni fi FLAGS
English: Adrenal haemorrhage
Maltese: Emorraġija adrenali
English: Tegafur is a prodrug of 5-FU with good oral bioavailability.
Maltese: Tegafur huwa prodrug ta' 5-FU b'bijodisponibilità orali tajba.
English: Baseline or Grade 1
Maltese: Linja bażi jew Grad 1
English: Other fluoropyrimidines
Maltese: Fluoropyrimidines oħra
English: The oteracil component of Teysuno did not affect the pharmacokinetic profiles of 5-FU, tegafur, gimeracil, FBAL, or uracil.
Maltese: Il-komponent oteracil ta' Teysuno ma affettwax il-profili farmakokinetiċi ta' 5-FU, tegafur, gimeracil, FBAL, jew uracil.
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC53.
Maltese: Grupp farmakoterapewtiku: sustanzi antineoplastiċi, antimetaboliti, Kodiċi ATC:
English: In vitro evaluation using human liver microsomes indicated that neither tegafur, gimeracil nor oteracil showed any relevant inhibitory effects on enzyme activities of the cytochrome P450 isoforms tested (i.e., CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4).
Maltese: L-evalwazzjoni in vitro permezz ta' mikrosomi tal-fwied tal-bniedem indikat li la tegafur, gimeracil lanqas oteracil ma wrew effetti impeditorji rilevanti fuq l-attivitajiet enzimatiċi tal-isoformi ta' cytochrome P450 ittestjati (i.e., CYP1A1/2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E1 u CYP3A4).
English: Cardiac failure, acute myocardial infarction, pericardial effusion, atrial fibrillation, angina pectoris, cardiac fibrillation, tachycardia, palpitations
Maltese: Falliment kardijaku, infart mijokardjali akut, effużjoni perikardjali, fibrilazzjoni atrijali, anġina pektoris, fibrillazzjoni kardijaka, takikardja, palpitazzjonijiet
English: Acute hepatic failure
Maltese: Falliment epatiku akut
English: INFORMATION IN BRAILLE Teysuno 20 mg/5.8 mg/15.8 mg 17.
Maltese: INFORMAZZJONI BIL-BRAILLE Teysuno 20 mg/5.8 mg/15.8 mg 17.
English: In a study performed in patients with renal impairment, the most common adverse reactions reported over all cycles across all cohorts were diarrhoea (57.6%), nausea (42.4%), vomiting (36.4%), fatigue (33.3%) and anaemia (24.2%).
Maltese: Fi studju li sar fuq pazjenti b'indeboliment tal-kliewi, l-aktar reazzjonijiet avversi komuni rapportati fuq iċ-ċikli kollha fil-koorti kollha kienu dijarea (57.6%), dardir (42.4%), remettar (36.4%), għeja (33.3%) u anemija (24.2%).
English: INFORMATION IN BRAILLE Teysuno 15 mg/4.35 mg/11.8 mg 17.
Maltese: INFORMAZZJONI BIL-BRAILLE Teysuno 15 mg/4.35 mg/11.8 mg 17.
English: Calculate BSA to 2 decimal places.
Maltese: Ikkalkula BSA għal 2 postijiet deċimali.
English: Table 8: Demographics and baseline characteristics of patients in the FLAGS study
Maltese: Tabella 8: Id-demografija u l-karatteristiċi tal-linja bażi ta' riferiment ta' pazjenti fl-istudju ta' FLAGS
English: Platelet count ≥100 x 109/l
Maltese: Għadd ta' plejtlits ≥100 x 109/l
English: Hazard Ratio [95% CI]
Maltese: Proporzjon ta' Ħsara [95% CI]
English: Nordic Drugs Tlf: +46 40-36 66 00 info@nordicdrugs.no
Maltese: Tlf: +46 40-36 66 00 info@nordicdrugs.no
English: Capsule contents: lactose monohydrate, magnesium stearate Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulphate, talc
Maltese: Kull kapsula fiha: lactose monohydrate, magnesium stearate Il-qoxra tal-kapsula: gelatin, red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulphate, talc
English: After multiple dose administration (30 mg/m2, expressed as tegafur content, twice daily for 14 days; N=10), the median Tmax of tegafur, gimeracil, and oteracil was 0.8, 1.0, and 2.0 hours, respectively, and the corresponding mean ± SD AUC(0-12h) and Cmax was 19967 ± 6027 ng.hr/ml and 2970 ± 852 ng/ml for tegafur, 1483 ± 527 ng.hr/ml and 305 ± 116 ng/ml for gimeracil, and 692 ± 529 ng.hr/ml and 122 ± 82 ng/ml for oteracil.
Maltese: Wara t-teħid ta' doża multipla (30 mg/m2, imfisser bħala kontenut ta' tegafur, darbtejn kuljum għal 14il jum; N=10), it-Tmax medjan ta' tegafur, gimeracil, u oteracil kienu ta' 0.8, 1.0, u 2.0 sigħat, rispettivament, u l-medja korrispondenti ± SD AUC(0-12h) u Cmax kienu 19967 ± 6027 ng.hr/ml u 2970 ± 852 ng/ml għal tegafur, 1483 ± 527 ng.hr/ml u 305 ± 116 ng/ml għal gimeracil, u 692 ± 529 ng.hr/ml u 122 ± 82 ng/ml għal oteracil.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity reaction, nail disorder
Maltese: Nekrolisi epidermali tossika, sindromu ta' StevensJohnson, reazzjoni ta' fotosensitività, disturbi tad-dwiefer
English: Fatal cases have been reported following capecitabine interaction.
Maltese: Ġew irrappurtati każijiet fatali wara interazzjoni ma' capecitabine.
English: • Severe bone marrow suppression (severe leukopaenia, neutropaenia, or thrombocytopaenia; see section 4.2, Table 5).
Maltese: • Trażżin sever tal-mudullun (lewkopenija severa, newtropenija, jew tromboċitopenija; ara sezzjoni 4.2, Tabella 5).
English: Teysuno contains the active substances tegafur gimeracil and oteracil.
Maltese: Teysuno fih is-sustanzi attivi tegafur, gimeracil u oteracil.
English: the median Tmax for Teysuno components tegafur, gimeracil, and oteracil was 0.5, 1.0, and 2.0 hours, respectively, and the mean ± standard deviation (SD) AUC0-inf and Cmax was 14595 ± 4340 ng.hr/ml and 1762 ± 279 ng/ml for tegafur, 1884 ± 640 ng.hr/ml and 452 ± 102 ng/ml for gimeracil, 556 ± 281 ng.hr/ml and 112 ± 52 ng/ml for oteracil.
Maltese: N=14), It-Tmax medjan għal komponenti ta' Teysuno tegafur, gimeracil, u oteracil kienu ta' 0.5, 1.0, u 2.0 sigħat, rispettivament, u l-medja ± id-devjazzjoni standard (SD) AUC0-inf u Cmax kienu ta' 14595 ± 4340 ng.hr/ml u 1762 ± 279 ng/ml għal tegafur, 1884 ± 640 ng.hr/ml u 452 ± 102 ng/ml għal gimeracil, 556 ± 281 ng.hr/ml u 112 ± 52 ng/ml għal oteracil.
English: Each pack contains either 42 capsules, 84 capsules or 126 capsules.
Maltese: Kull pakkett fih 42 kapsula, 84 kapsula jew 126 kapsula.
English: Musculoskeletal pain
Maltese: Uġigħ muskoloskeletriku
English: Glucose/galactose intolerance/malabsorption
Maltese: Intolleranza/assorbiment mhux tajjeb ta' glucose/galactose
English: The 5-FU pharmacokinetic profile was similar in the presence and absence of oteracil.
Maltese: Il-profil farmakokinetiku ta' 5-FU kien simili fil-preżenza u l-assenza ta' oteracil.
English: Gimeracil increases 5-fluorouracil (5-FU) exposure by inhibiting DPD, the primary enzyme for metabolizing 5-FU.
Maltese: Gimeracil iżid l-espożizzjoni ta' 5-fluorouracil (5-FU) billi jimpedixxi DPD, l-enzima prinċipali li timmetabolizza 5-FU.
English: Hyperbilirubinaemia, alanine aminotransferase increased, aspartate aminotransferase increased
Maltese: Iperbilirubinemija, żieda f'alanine aminotransferase, żieda f'aspartate aminotransferase
English: A Phase I study established the current regimen by evaluating cohorts of Teysuno and cisplatin of 30 mg/m2 and 60 mg/m2 (dose-limiting toxicities [DLTs] seen were fatigue, and diarrhoea and dehydration); 25 mg/m2 and 60 mg/m2; and 25 mg/m2 and 75 mg/m2.
Maltese: Studju ta' Fażi I stabilixxa l-programm ta' kura attwali billi evalwa koorti ta' Teysuno u cisplatin ta' 30 mg/m2 u 60 mg/m2 (restrizzjonijiet ta' doża minħabba tossiċitajiet [DLTs] li dehru kienu għeja, u dijarra u diżidrazzjoni); 25 mg/m2 u 60 mg/m2; u 25 mg/m2 u 75 mg/m2.
English: Comparison of safety between 71 patients ≥70 years old (elderly) and 450 patients <70 years old treated with Teysuno in combination with cisplatin in the FLAGS study demonstrated that the incidence of all Grade 3 or higher adverse reactions (62% vs 52%), all serious adverse reactions (30% vs 19%), and the rate of premature withdrawal due to adverse reactions from both Teysuno and cisplatin (21% vs 12%) appeared to be higher among patients ≥70 years old.
Maltese: Paragun ta' sigurtà fost 71 pazjent ≥70 sena (anzjani) u 450 pazjent <70 sena kkurati b'Teysuno flimkien ma' cisplatin fl-istudju FLAGS wera li l-inċidenza ta' reazzjonijiet avversi ta' Grad 3 jew aktar (62% vs 52%), ir-reazzjonijiet avversi serji kollha (30% vs 19%), u r-rata ta' waqfien prematur dovuta għal reazzjonijiet avversi kemm minn Teysuno u cisplatin (21% vs 12%) dehret li kienet ogħla fost pazjenti ≥70 sena.
English: Standard anti-diarrhoeal therapy (e.g., loperamide) and intravenous fluids/electrolytes should be initiated early when diarrhoea develops.
Maltese: Terapija standard kontra d-dijarea (eż., loperamide) u fluwidi/elettroliti ġol-vina għandhom jinbdew meta tiżviluppa d-dijarea.
English: Second dose reductiona: to 15 mg/m2 BSA ≥ 2.17 m2
Maltese: It-tieni tnaqqis fid-dożaa: għal 20 mg/m2 BSA ≥ 2.17 m2
English: Nordic Drugs Tlf: +45 70 20 08 40 info@nordicdrugs.dk
Maltese: Tlf: +45 70 20 08 40 info@nordicdrugs.dk
English: Exposure of 5-FU was not statistically significantly different between the two groups.
Maltese: L-espożizzjoni għal 5-FU ma kienx statistikament sinifikanti differenti bejn iż-żewġ gruppi.
English: The gimeracil component did not affect the pharmacokinetic profile of tegafur.
Maltese: Il-komponent ta' gimeracil ma affettwax il-profil farmakokinetiku ta' tegafur.
English: Patient characteristics are provided in Table 8.
Maltese: Modifikazzjonijiet mnaqqsa għal tossiċitajiet ematoloġiċi Tabella 5:
English: However, polyglutamated methotrexate inhibits thymidylate synthase and dihydrofolate reductase, potentially increasing cytotoxicity of 5-FU.
Maltese: Madanakollu, polyglutamated methotrexate jimpedixxi thymidylate synthase u dihydrofolate reductase, u potenzjalment iżid iċ-ċitotossiċità ta' 5-FU.
English: Neutropenia, leukopenia, anaemia, thrombocytopenia
Maltese: Newtropenja, lewkopenija, anemija, tromboċitopenija
English: Median [95% CI].
Maltese: Medjan [95% CI]. xhur
English: Teysuno is contraindicated during breast-feeding (see section 4.3).
Maltese: Teysuno huwa kontraindikat fit-tqala (ara sezzjoni 4.3).
English: Rare side effects (may affect 1 to 10 in 10,000 people) and very rare side effects (may affect less than 1 in 10,000 people) include:
Maltese: Effetti sekondarji rari (li jistgħu jaffettwaw minn 1 sa 10 persuni f'10,000) u effett sekondarji rari ħafna (li jaffettwa inqas minn persuna 1 f'10,000) jinkludu:
English: 20 mg capsulea (white)
Maltese: kapsula ta' 20 mga (bajda)
English: The main metabolic pathway for tegafur is through conversion to 5-FU via CYP2A6 in the liver, whereas gimeracil was stable in human liver homogenate (S9 fraction) with adenosine 3'-phosphate 5'-phosphosulfphate lithium salt (PAPS; a co-factor for sulfotransferase) or nicotinamide adenine dinucleotide phosphate (NADPH).
Maltese: Il-passaġġ metaboliku ewlieni għal tegafur isir bil-konverżjoni ta' 5-FU permezz ta' CYP2A6 filfwied, filwaqt li gimeracil kien stabbli fl-omoġenat tal-fwied tal-bniedem (frazzjoni S9) b' adenosine 3'-phosphate 5'phosphosulfphate lithium salt (PAPS; ko-fattur għal sulfotransferase) jew nicotinamide adenine dinucleotide phosphate (NADPH).
English: Musculoskeleta l and connective tissue disorders
Maltese: Disturbi muskoloskeletri ċi u tat-tessut konnettiv
English: It is a fixed dose combination of three active substances, tegafur, which after absorption is converted into the anti-cancer substance 5-FU; gimeracil, a dihydropyrimidine dehydrogenase (DPD) inhibitor to prevent degradation of 5-FU by the body; and, oteracil, an orotate phosphoribosyltransferase (OPRT) inhibitor that decreases the activity of 5-FU in normal gastrointestinal mucosa.
Maltese: Huwa kombinazzjoni ta' tliet sustanzi attivi f'doża fissa, tegafur, li wara li jiġi assorbit jiġi konvertit fis-sustanza ta' kontra l-kanċer 5-FU; gimeracil, impeditur ta' dihydropyrimidine dehydrogenase (DPD) li jipprevjeni d-degradazzjoni ta' 5-FU mill-ġisem; u, oteracil, impeditur ta' orotate phosphoribosyltransferase (OPRT) li jnaqqas l-attività ta' 5-FU f'mukosa gastrointestinali normali.
English: • Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction).
Maltese: • Trattament reċenti jew fl-istess waqt bi brivudine (ara sezzjonijiet 4.4 u 4.5 għall-interazzjoni bejn mediċina u oħra).
English: 15 mg capsulea (brown/white)
Maltese: kapsula ta' 15 mga (kannella/bajd a)
English: Teysuno is contraindicated in pregnancy (see section 4.3).
Maltese: Teysuno huwa kontraindikat waqt it-treddigħ (ara sezzjoni 4.3).
English: Among the metabolites, 9.5% to 9.7% of the administered tegafur was excreted in the urine as 5-FU and approximately 70% to 77% as FBAL, accounting for approximately 83% to 91% of the administered Teysuno dose (total tegafur + 5-FU + FBAL).
Maltese: Fost il-metaboliti, 9.5% sa 9.7% tat-tegafur li ngħata kien eliminat fl-awrina bħala 5-FU u madwar 70% sa 77% bħala FBAL, li jgħodd għal madwar 83% sa 91% tad-doża ta' Teysuno li ngħatat (tegafurtotali + 5-FU + FBAL).
English: In man, the apparent terminal elimination half-life (T1/2) of 5-FU observed after administration of Teysuno (containing tegafur, a 5-FU prodrug) was longer (approximately 1.6 - 1.9 hours) than that previously reported after intravenous administration of 5-FU (10 to 20 minutes).
Maltese: Fil-bniedem, ġie osservat li l-half-life apparenti ta' eliminazzjoni terminali (T1/2) ta' 5-FU wara li ngħata Teysuno (li fih tegafur, prodrug ta' 5-FU) kien itwal (madwar 1.6 - 1.9 sigħat) minn dak rapportat qabel wara l-għoti ġol-vina ta' 5-FU (10 sa 20 minuta).
English: Among 593 patients treated with Teysuno in combination with cisplatin, the most common severe adverse reactions (Grade 3 or higher with frequency of at least 10%) were neutropaenia, anaemia, and fatigue.
Maltese: Fost 593 pazjent ikkurat b'Teysuno flimkien ma' cisplatin, l-aktar reazzjonijiet komuni avversi severi (Grad 3 jew ogħla bi frekwenza ta' mill-anqas 10%) kienu newtropenija, anemija, u għeja.
English: First dose reductiona: to 20 mg/m2 BSA ≥ 2.13 m2
Maltese: L-ewwel tnaqqis fid-dożaa: għal 20 mg/m2 BSA ≥ 2.13 m2
English: Median [95% CI], months
Maltese: Medjan [95% CI], xhur
English: Vertigo, ear congestion, ear discomfort
Maltese: Vertigo, konġestjoni tal-widna, skonfort tal-widna
English: The median Tmax for 5-FU was 2.0 hours and the mean AUC(0-12h) and Cmax was 870 ± 405 ng.hr/ml and 165 ± 62 ng/ml, respectively.
Maltese: It-Tmax medjan għal 5-FU kien ta' 2.0 sigħat u l-AUC(0-12h) medjan u Cmax kien ta' 870 ± 405 ng.hr/ml u 165 ± 62 ng/ml, rispettivament.
English: A population PK analysis of Teysuno components and metabolites assessed the influence of various factors, including gender, age, food, ethnicity (Caucasian vs Asian), renal function, and hepatic function in 315 patients.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tal-komponenti u l-metaboliti ta' Teysuno assessjat l-influwenza ta' fatturi diversi, li jinkludu l-ġeneru sesswali, età, ikel, etnicità (Kawkasi vs Ażjatiku), funzjoni tal-kliewi, u funzjoni tal-fwied fi 315-il pazjent.
English: Marketing Authorisation Holder Nordic Group B.V.
Maltese: FIS-SUQ Nordic Group B.V.
English: • Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil) or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanzi attivi (tegafur, gimeracil, u oteracil) jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1).
English: DPD inducers
Maltese: Induċaturi ta' DPD
English: Platelets Haemoglobin Teysuno dose modification
Maltese: Emaglobina Modifikazzjoni fid-doża ta' Teysuno
English: The median Tmax for 5-FU was 2.0 hours and the mean AUC0-inf and Cmax was 842 ± 252 ng.hr/ml and 174 ± 58 ng/ml.
Maltese: It-Tmax medjan għal 5-FU kien ta' 2.0 sigħat u l-AUC-0-inf medjan u Cmax kien ta' 842 ± 252 ng.hr/ml u 174 ± 58 ng/ml.
English: This CYP2A6*4 allele is uncommon in the Caucasian population.
Maltese: Dan l-allel ta' CYP2A6*4 mhux komuni fil-popolazzjoni Kawkasi.