FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.2% of patients had diarrhoea classified as Grade 4.
Maltese: 0.2 % tal-pazjenti kellhom dijarea kklassifikata bħala Grad 4.
English: • Diet modifications
Maltese: • Modifikazzjonijiet fid-dieta
English: Pooled safety data of 1710 patients treated with Nerlynx monotherapy showed a higher incidence of dermatologic toxicities in Asian patients (57.1%) versus Caucasian patients (34.6%).
Maltese: Data ta' sigurtà miġbura tal-1710 pazjenti ttratti b'monoterapija b'Nerlynx uriet inċidenza ogħla ta' tossiċitajiet dermatoloġiċi f'pazjenti Asjatiċi (57.1%) kontra pazjenti Kawkasi (34.6%).
English: Following concomitant administration with repeated doses of 600 mg rifampicin, a strong CYP3A4/Pgp inducer, neratinib exposures were significantly decreased with mean values that were 24% and 13% of reference values (neratinib administered alone) for Cmax and AUC, respectively.
Maltese: Wara għoti konkomitanti b'dożi ripetuti ta' 600 mg rifampicin, induttur qawwi ta' CYP3A4/Pgp, l esponimenti għal neratinib tnaqqsu b'mod sinifikanti b'valuri medji li kienu 24 % u 13 % tal-valuri ta' referenza (neratinib mogħti waħdu) għas-Cmax u għall-AUC, rispettivament.
English: Nerlynx 40 mg film-coated tablets neratinib
Maltese: Nerlynx 40 mg pilloli miksijin b'rita neratinib
English: The most common Grade 3-4 adverse reactions were diarrhoea (Grade 3, 36.9% and Grade 4, 0.2%) and vomiting (Grade 3, 3.4% and Grade 4, 0.1%).
Maltese: Ir-reazzjonijiet avversi ta' Grad 3-4 l-aktar komuni kienu dijarea (Grad 3, 36.9% u Grad 4, 0.2%) u rimettar (Grad 3, 3.4% u Grad 4, 0.1%).
English: Neratinib was not a potent inhibitor of human BSEP efflux transporter activity in vitro, with a reported IC50 value of > 10µM.
Maltese: Neratinib ma kienx inibitur qawwi ta' attività tat-trasportatur ta' eflluss ta' BSEP tal-bniedem in vitro, b'valur IC50 irrappurtat ta' > 10µM.
English: • Grade 1 diarrhoea [increase of < 4 stools per day over baseline]
Maltese: • Dijarea ta' Grad 1 [żieda ta' < 4 ippurgar kuljum aktar mil-linja bażi]
English: 160 mg daily
Maltese: 160 mg kuljum
English: The incidence of serious adverse reactions in the Nerlynx arm vs placebo arm was 7.0% vs. 5.7% (<65 years-old) and 9.9% vs. 8.1% (≥65 years-old).
Maltese: 7.0 % kontra 5.7 % (<65 sena) u 9.9 % kontra 8.1 % (≥65 sena).
English: Concomitant use of strong CYP3A4/P-gp inhibitors (e.g. atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, ketoconazole, itraconazole, clarithromycin, telithromycin, and voriconazole) should be avoided.
Maltese: nelfinavir, ritonavir, saquinavir, ketoconazole, itraconazole, clarithromycin, telithromycin, u voriconazole) għandu jiġi evitat.
English: Neratinib produced no inhibitory activity towards the uptake transporters, OATP1B1*1a, OATP1B3, OAT1, OAT3 and OCT2, with reported IC50 values were > 10µM.
Maltese: Neratinib ma pproduċa l-ebda attività inibitorja lejn it-trasportaturi tat-teħid, OATP1B1*1a, OATP1B3, OAT1,
English: The neratinib metabolites M3, M6, M7 and M11 were shown to have similar potencies to neratinib in either in vitro enzyme (binding assays) or cell based assays against cells expressing ERBB1, ERBB2 (HER2) and ERBB4.
Maltese: Il-metaboliti ta' neratinib M3, M6, M7 u M11 urew li kellhom qawwiet simili għal neratinib f'jew enzima in vitro (assaysta' twaħħil) jew assaysi bbażati fuq iċ ċellula li jesprimu ERBB1, ERBB2 (HER2) u ERBB4.
English: • Grade 4 ALT (>20 x ULN)
Maltese: • ALT ta' Grad 4 (>20 x ULN)
English: CYP3A4/P-gp inducers
Maltese: Indutturi ta' CYP3A4/Pgp
English: The safety of Nerlynx and how effective it is has not been studied in this age group.
Maltese: Is-sigurtà ta' Nerlynx u kemm huwa effettiv ma ġietx studjata f'dan il-grupp ta' età.
English: In the Nerlynx monotherapy group, 16.7% of patients experienced rash.
Maltese: Fil-grupp ta' monoterapija b'Nerlynx, 16.7 % tal-pazjenti esperjenzaw raxx.
English: Hepatic-associated adverse reactions in the pivotal phase III study, ExteNET (3004), were reported more frequently in the Nerlynx arm compared to the placebo arm (12.4% vs. 6.6%), due primarily to alanine aminotransferase (ALT) increased (8.5% vs. 3.2%), aspartate aminotransferase (AST) increased (7.4 vs 3.3%) and blood alkaline phosphatase increased (2.1% vs. 1.1%).
Maltese: III, ExteNET (3004), ġew irrappurtati b'mod aktar frekwenti fil-fergħa ta' Nerlynx meta mqabbel mal-fergħa ta' plaċebo (12.4% kontra 6.6%), minħabba primarjament żieda fl-alanina aminostransferażi (ALT) (8.5% kontra 3.2%), żieda fl-aspartat aminotransferażi (AST) (7.4 kontra 3.3%) u żieda fil-fosfatażi alkalina fid-demm
English: In the Nerlynx monotherapy group, 7.8% patients experience nail disorders.
Maltese: Fil-grupp ta' monoterapija b'Nerlynx, 7.8 % tal-pazjenti esperjenzaw disturbi tad-difer.
English: • Grade 3 diarrhoea [increase of ≥ 7 stools per day over baseline; incontinence; hospitalization indicated; limiting self-care activities of daily living] lasting ≤ 2 days
Maltese: • Dijarea ta' Grad 3 [żieda ta' ≥ 7 ippurgar kuljum aktar mil-linja bażi; inkontinenza; dħul fl-isptar indikat; li tillimita attivitajiet ta'
English: Neratinib at 10 µM appeared to inhibit the BCRP efflux transporter.
Maltese: Neratinib b'10 µM deher li jinibixxi t-trasportatur ta' effluss ta' BCRP.
English: Neratinib binds to the HER2 receptor, reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and potently inhibits tumour cell proliferation in vitro.
Maltese: HER2, inaqqas l-EGFR u l-awtofosforilazzjoni ta' HER2, il-passaġġi tal-għoti ta' sinjali downstream ta' MAPK u AKT, u potenzjalment jinibixxi il-profilerazzjoni taċ-ċellula tat-tumur in vitro.
English: Neratinib is metabolised primarily in liver microsomes by CYP3A4 and to a lesser extent by flavincontaining monooxygenase (FMO).
Maltese: Neratinib jiġi metabolizzat primarjament f'mikrożomi tal-fwied minn CYP3A4 u sa livell inqas minn monoossiġenażi li fiha flavin (FMO).
English: The incidence of Grade 1 and Grade 2 was 13.3% and 2.9% respectively; 0.4% of Nerlynx-treated patients experienced Grade 3 rash.
Maltese: L-inċidenza ta' Grad 1 u Grad 2 kienet 13.3 % u 2.9 % rispettivament; 0.4 % tal-pazjenti ttrattati b'Nerlynx esperjenzaw raxx ta' Grad 3.
English: Neratinib inhibited EGFR and/or HER2-expressing carcinoma cell lines with a cellular IC50 <100 nM.
Maltese: Neratinib inibixxa l-EGFR u/jew il-linji ċellulari tal-karċinoma li jesprimu HER2 b'IC50 ċellulari <100 nM.
English: In healthy subjects, digoxin increased Cmax by 54% and AUC increased by 32% when co-administered with multiple oral doses of neratinib 240 mg compared with exposures of digoxin alone.
Maltese: F'individwi b'saħħithom, digoxin żied is-Cmax b'54 % u l-AUC żdiedet bi 32 % meta ngħata flimkien ma' ħafna dożi orali ta' neratinib 240 mg meta mqabbel ma' esponimenti ta' digoxin waħdu.
English: Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin should be monitored at 1 week, then monthly for the first 3 months and every 6 weeks thereafter while on treatment or as clinically indicated (see Section 4.2).
Maltese: It-testijiet tal-funzjoni tal-fwied inkluż alanina aminotransferażi (ALT), aspartat aminotransferażi (AST), u bilirubina totali għandhom jiġu mmonitorjati wara ġimgħa, imbagħad kull xahar għall-ewwel 3 xhur u kull 6 ġimgħat wara dan waqt li jkunu għaddejjin bit-trattament jew kif indikat klinikament (ara Sezzjoni 4.2).
English: 3 Includes nail disorder, paronychia, onychoclasis, and nail discolouration.
Maltese: 3 Jinkludi disturb tad-difer, paronikja, onikoklażi, u skulurament tad-difer.
English: The median cumulative duration of any grade diarrhoea was 59 days and the median cumulative duration of Grade 3 diarrhoea was 5 days.
Maltese: Id-durata kumulattiva medjana ta' dijarea ta' kwalunkwe grad kienet 59 jum u d-durata kumulattiva medjana ta' dijarea ta' Grad 3 kienet 5 ijiem.
English: Elderly patients (≥65 years of age) are at a higher risk of renal insufficiency and dehydration which may be a complication of diarrhoea and these patients should be carefully monitored.
Maltese: Pazjenti anzjani (età ta' ≥65 sena) jinsabu f'riskju ogħla ta' indeboliment tal-kliewi u deidrazzjoni li tista' tkun kumplikazzjoni tad-dijarea u dawn il-pazjenti għandhom jiġu mmonitorjati b'attenzjoni.
English: Prior Trastuzumab
Maltese: Doża maqbuża
English: In the analysis of pooled safety data, the majority of TEAEs in the Skin and Subcutaneous Disorders SOC in Asians were Grade 1 (43.3%) and Grade 2 (12.3%); in Caucasians, the incidence of Grade 1 and Grade 2 events was 25.6% and 7.8%, respectively.
Maltese: Fl-analiżi tad-data ta' sigurtà miġbura, il-maġġoranza ta' TEAEs fis-SOC għad-Disturbi fil-Ġilda u fit-Tessuti ta' Taħt il-Ġilda fl-Asjatiċi kienu Grad 1 (43.3%) u Grad 2 (12.3%); fil-Kawkasi, linċidenza ta' avvenimenti ta' Grad 1 u Grad 2 kienet 25.6 % u 7.8 %, rispettivament.
English: Treatment-emergent adverse reactions leading to hospitalisation in the Nerlynx arms versus the placebo arm was 6.3% vs 4.9% in the <65 years-old group and 8.7% vs. 8.1% in the ≥65 years-old group.
Maltese: Reazzjonijiet avversi li dehru milt-trattament li wasslu għal dħul fl-isptar fil-fergħat ta' Nerlynx kontra l-fergħa ta' plaċebo kienu 6.3 % kontra 4.9 % fil-grupp ta' <65 sena u 8.7 % kontra 8.1 % fil grupp ta' ≥65 sena.
English: A single 240 mg dose of neratinib combined with lansoprazole decreased AUC by up to 70%.
Maltese: 240 mg ta' neratinib flmkien ma' lansoprazole jnaqqsu l-AUC b'sa 70 %.
English: A single dose of 240 mg neratinib taken with food increased Cmax and AUC by approximately 17% and 23%, respectively, compared with administration in the fasting state.
Maltese: Doża waħda ta' 240 mg neratinib meħuda mal-ikel żiedet is-Cmax u l-AUC b'madwar 17 % u 23 %, rispettivament, meta mqabbel ma' għoti flistat sajjem.
English: In patients with known cardiac risk factors, conduct cardiac monitoring, including assessment of LVEF, as clinically indicated.
Maltese: F'pazjenti b'fatturi ta' riskju kardijaku magħrufa, wettaq monitoraġġ kardijaku, inkluż valutazzjoni tal-LVEF, kif indikat klinikament.
English: Grade 3 adverse reactions were reported in 1.6% vs 0.5% and Grade 4 adverse reactions were reported in 0.2% vs. 0.1%, Nerlynx- and placebo-treated patients, respectively.
Maltese: Reazzjonijiet avversi ta' Grad 3 ġew irrappurtati f'1.6 % kontra 0.5 % u reazzjonijiet avversi ta' Grad 4 ġew irrappurtati f'0.2 % kontra 0.1 %, pazjenti ttrattati b'Nerlynx u dawk iittrattati bi plaċebo, rispettivament.
English: • Grade 3 bilirubin (>3-10 x ULN)
Maltese: • Bilirubina ta' Grad 3 (>3-10 x ULN)
English: The table below lists adverse reactions observed with neratinib based on the assessment of pooled data from 1,710 patients.
Maltese: It-tabella t'hawn taħt telenka r-reazzjonijiet avversi osservati b'neratinib abbażi tal-valutazzjoni tad data miġbura minn 1,710 pazjenti.
English: At baseline, 57.4% had hormone receptor positive disease (defined as ER-positive and/or PgR-positive), 23.6% were node negative, 46.8% had one to three positive nodes and 29.6% had four or more positive nodes.
Maltese: Fil-linja bażi, 57.4 % kellhom marda pożittiva għar-riċettur tal-ormon (definita bħala pożittiva għall-ER u/jew pożittiva għall-PgR), 23.6 % kienu negattivi għan-nodulu, 46.8 % kellhom wieħed sa tliet noduli pożittivi u 29.6 % kellhom erba' noduli pożittivi jew aktar.
English: Following the administration of a single radiolabelled dose of 200 mg neratinib oral solution, 97.1% and 1.1% of the administered dose was recovered in the faeces and urine, respectively.
Maltese: L-eskrezzjoni ta' neratinib hija primarjament permezz tal-ippurgar Wara l-għoti ta' doża waħda radjutikkettata ta' 200 mg neratinib soluzzjoni orali, 97.1 % u 1.1 % tad doża mogħtija ġie rkuprat fl-ippurgar u fl-awrina, rispettivament.
English: Invasive disease-free survival Disease-free survival including ductal carcinoma in situ
Maltese: Sopravivenza mingħajr marda inkluż karċinoma fil-kanal in situ
English: Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: Missed dose
Maltese: Noduli Pożittivi
English: Hepatotoxicity
Maltese: Plaċebo
English: Each film-coated tablet contains neratinib maleate, equivalent to 40 mg neratinib.
Maltese: Kull pillola miksija b'rita fiha neratinib maleate, ekwivalenti għal 40 mg neratinib.
English: Hazard ratio (95% CI)2
Maltese: Proporzjon ta' periklu (95% C
English: Neratinib may inhibit breast cancer resistance protein (BCRP) moderately as suggested by in vitro studies.
Maltese: Neratinib jista' jinibixxi l-proteina ta' reżistenza għall-kanċer tas-sider (BCRP) moderatament kif issuġġerit minn studji in vitro.
English: Of the 1,660 patients treated with Nerlynx monotherapy without loperamide prophylaxis, 94.6% experienced at least 1 episode of diarrhoea.
Maltese: Mill-1,600 pazjent ittrattatb'monoterapija b'Nerlynx mingħajr profilassi ta' loperamide, 94.6 %
English: Nerlynx has not been studied in patients with severe renal impairment including patients on dialysis.
Maltese: Nerlynx ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi sever inkluż pazjenti fuq dijaliżi.
English: Nerlynx dose modifications for adverse reactions
Maltese: Modifikazzjonijiet fid-doża għal reazzjonijiet avversi
English: Oval, red film-coated tablet with ‘W104' debossed on one side.
Maltese: Pillola miksija b'rita ovali ħamra b'“W104” imnaqqxa fuq naħa waħda.
English: • Grade 4 bilirubin (>10 x ULN)
Maltese: • Bilirubina ta' Grad 4 (>10 x ULN)
English: In patients with severe hepatic impairment (Child-Pugh C) there is a 2.8-fold increase of exposure to neratinib (see Section 5.2).
Maltese: Indeboliment tal-fwied F'pazjenti b'indeboliment tal-fwied sever (Child-Pugh C) hemm żieda ta' 2.8 darbiet ta' esponiment għal neratinib (ara Sezzjoni 5.2).
English: Other medicines and Nerlynx
Maltese: Mediċini oħra u Nerlynx
English: Dose modifications for diarrhoea Severity of diarrhoea*
Maltese: Tabella 3: Modifikazzjonijiet fid-doża għad-dijarea Severità tad-dijarea*
English: • Grade 2 diarrhoea lasting 5 days or longer‡
Maltese: • Dijarea ta' Grad 2 li ddum 5 ijiem jew aktar‡
English: Each film coated tablet contains neratinib maleate equivalent to 40 mg neratinib.
Maltese: Kull pillola miksija b'rita fiha neratinib maleate ekwivalenti għal 40 mg neratinib.
English: 1-3 Positive Nodes
Maltese: 1-3 Noduli Pożittivi
English: There was no difference in frequency of SAEs in the Skin SOC between Asian and Caucasian subgroups.
Maltese: Ma kien hemm l-ebda differenza fil-frekwenza ta' SAEs fis-SOC Ġilda bejn is-sottogruppi ta' Asjatiċi u Kawkasi.
English: Sequential
Maltese: Sekwenzjali
English: • Fail to recover to Grade 0 to 1 from treatment-related toxicity,
Maltese: • Ma jirnexxilhomx jirkupraw għal Grad 0 sa 1 minn tossiċità relatata mat-trattament,
English: Co-administration of a single oral dose of 240 mg of neratinib in the presence of ketoconazole (400 mg once daily for 5 days), a strong CYP3A4/P-gp inhibitor, increased neratinib systemic exposure.
Maltese: (400 mg darba kuljum għal 5 ijiem), inibitur qawwi ta' CYP3A4/Pgp, esponiment sistemiku miżjud għal neratinib.
English: The serious adverse reactions most frequently reported in the ≥65 years-old group were vomiting (2.3%), diarrhoea (1.7%), dehydration (1.2%), and renal failure (1.2%).
Maltese: Ir-reazzjonijiet avversi serji li ġew irrappurtati bl-aktar mod frekwenti fil-grupp ta' età ta' ≥65 sena kienu rimettar (2.3%), dijarea (1.7%),
English: o The Summary of Product Characteristics o Guide for healthcare professionals o Patient educational material The Guide for healthcare professionals shall contain the following key elements: o Name of the product, active substance and approved indication of the product o Relevant information on the safety concern “Gastrointestinal toxicity (diarrhoea)” (e.g. seriousness, severity, frequency, time to onset, duration, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern o Key message to convey in patients counselling on how to prevent and minimise Gastrointestinal toxicity through appropriate monitoring and management: o prophylactic treatment with antidiarrhoeal medicinal product o dietary changes o dose modification (with guideline to adjust doses)/ discontinuation of treatment o The importance of handing over the educational material to the patients/carers at the end of counselling o Remarks on the importance of reporting ADRs
Maltese: Tossiċità gastrointestinali permezz ta' monitoraġġ u ġestjoni xierqa: o kura profilattika bi prodott mediċinali kontra d-dijarea o bidla fid-dieta o modifikazzjoni fid-doża (b'linja gwida sabiex jiġu aġġustati d-dożi)/ twaqqif tal-kura o L-importanza li jingħata l-materjal edukattiv lill-pazjenti/persuni li jieħdu ħsiebhom fl-aħħar tal konsulenza o Rimarki dwar l-importanza tar-rappurtar ta' ADRs
English: The most common adverse reactions of any grade were diarrhoea (93.6%), nausea (42.5%), fatigue (27.3%), vomiting (26.8%), abdominal pain (22.7%), rash (15.4%), decreased appetite (13.7%), abdominal pain upper (13.2%), stomatitis (11.2%), and muscle spasms (10.0%).
Maltese: għeja (27.3%), rimettar (26.8%), uġigħ addominali (22.7%), raxx (15.
English: What you need to know before you take Nerlynx 3.
Maltese: X'għandek tkun taf qabel ma tieħu Nerlynx 3.
English: Discontinue Nerlynx for patients who:
Maltese: Waqqaf Nerlynx għal pazjenti li:
English: Grade 3 AST increased was reported in 0.5% vs 0.3% and Grade 4 AST increased was reported in 0.2% vs 0.0%, of Nerlynx- vs placebo-treated patients.
Maltese: Żieda fl-AST ta' Grad 3 ġiet irrappurtata f'0.5 % kontra 0.3 % u żieda fl-AST ta' Grad 4 ġiet irrappurtata f'0.2 % kontra 0.0 % ta' pazjenti kkurati b'Nerlynx kontra dawk ittrattati bi plaċebo.
English: Diarrhoea was also the most common adverse reaction leading to discontinuation, 14.4 % of patients treated with Nerlynx without loperamide prophylaxis discontinued treatment due to diarrhoea.
Maltese: Id-dijarea kienet ukoll ir-reazzjoni avversa l-aktar komuni li wasslet għal twaqqif, 14.4 % tal-pazjenti ttrattatib'Nerlynx mingħajr profilassi b'loperamide waqqfu t-trattament minħabba dijarea.
English: Co-administration with the following medical products that are strong inducers of the CYP3A4/P-gp isoform of cytochrome P450:
Maltese: L-għoti flimkien mal-prodotti mediċi li ġejjin li huma indutturi qawwija tal-iżoforma CYP3A4/Pgp taċ-ċitokromu P450:
English: • If grade 3 diarrhoea persists longer than 3weeks, discontinue Nerlynx permanently.
Maltese: • Jekk id-dijarea ta' grad 3 tippersisti għal aktar minn 3 ġimgħat, waqqaf Nerlynx għalkollox.
English: Left ventricular function
Maltese: Funzjoni ventrikolari tax-xellug
English: * Refer to Table 3 and Table 4 below for management of diarrhoea and hepatotoxicity † Per CTCAE v4.0
Maltese: * Irreferi għal Tabella 3 u Tabella 4 hawn taħt għall-ġestjoni tad-dijarea u tal-epatotossiċità
English: Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.).
Maltese: (eż. tossiċitajiet intollerabbli, reazzjonijiet avversi persistenti ta' Grad 2, eċċ.).
English: Some side effects associated with taking more Nerlynx than you should are: diarrhoea, nausea, vomiting and dehydration.
Maltese: Xi effetti sekondarji assoċjati mat-teħid ta' Nerlynx aktar milli suppost huma: dijarea, nawsja, rimettar u deidrazzjoni.
English: Nerlynx dose modification is recommended based on individual safety and tolerability.
Maltese: Il-modifikazzjoni fid-doża ta' Nerlynx hija rakkomandata abbażi tas-sigurtà u t-tollerabbiltà tal individwu.
English: Section 6), - if you have a severe liver problem, - if you are taking fluconazole (a medicine for fungal infections), - if you are taking rifampicin (a medicine for tuberculosis (TB)), - if you are taking erythromycin (antibiotic for infections), - if you are taking carbamazepine, phenobarbital, or phenytoin (medicines for seizures), - if you are taking diltiazem or verapamil (medicines for high blood pressure and chest pain), - if you are taking St. John's wort (herbal product for depression).
Maltese: - jekk għandek problema severa tal-fwied, - jekk qed tieħu fluconazole (mediċina għal infezzjonijiet fungali), - jekk qed tieħu rifampicin (mediċina għat-tuberkulożi (TB)), - jekk qed tieħu erythromycin (antibijotiku għall-infezzjonijiet), - jekk qed tieħu carbamazepine, phenobarbital, jew phenytoin (mediċini għall-aċċessjonijiet), - jekk qed tieħu diltiazem jew verapamil (mediċini għall-pressjoni għolja tad-demm u wġigħ fis sider),
English: Nerlynx has not been studied in patients with less than lower limit of normal left ventricular ejection fraction (LVEF) or with significant cardiac history.
Maltese: Nerlynx ma ġiex studjat f'pazjenti b'inqas mil-limitu aktar baxx tal-frazzjoni tal-ħruġ ventrikolari tax-xellug (LVEF) normali jew bi storja kardijaka sinifikanti.
English: Preliminary metabolite profiling in human plasma indicates that after oral administration, neratinib undergoes oxidative metabolism through CYP3A4.
Maltese: neratinib jgħaddi minn metaboliżmu ossidattiv permezz ta' CYP3A4.
English: • If diarrhoea resolves to Grade 0-1 in longer than one week, then resume Nerlynx treatment at reduced dose (see Table 1).
Maltese: • Jekk id-dijarea tiġi riżolta għal Grad 0-1 f'aktar minn ġimgħa, imbagħad kompli t-trattament b'Nerlynx b'doża mnaqqsa (ara Tabella 1).
English: Co-administration with moderate CYP3A4/P-gp inhibitors:
Maltese: L-għoti flimkien ma' inibituri moderati ta' CYP3A4/P-gp:
English: Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Table 1, Table 2, Table 3, and Table 4.
Maltese: Il-ġestjoni ta' xi reazzjonijiet avversi tista' teħtieġ interruzzjoni fid-doża u/jew tnaqqis fid doża kif muri fit-Tabella 1, Tabella 2, Tabella 3, u Tabella 4.
English: • Interrupt Nerlynx treatment
Maltese: • Waqqaf it-trattament b'Nerlynx għalkollox
English: It is currently unknown whether neratinib may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a barrier method.
Maltese: Bħalissa mhuwiex magħruf jekk neratinib jistax inaqqas l-effettività ta' kontraċettivi ormonali li jaħdmu sistemikament, u għalhekk nisa li jkunu qegħdin jużaw kontraċettivi ormonali li jaħdmu sistemikament għandhom iżidu metodu ta' kontraċezzjoni barriera.
English: Grapefruit juice should be avoided during treatment with Nerlynx (see Section 4.5).
Maltese: Il-meraq tal-grejpfrut għandu jiġi evitat waqt kura b'Nerlynx (ara Sezzjoni 4.5).
English: • Any grade with complicated features†
Maltese: • Kwalunkwe grad b'karatteristiċi kkumplikati†
English: • Grade 4 diarrhoea [life-threatening consequences; urgent intervention indicated]
Maltese: periklu għall-ħajja; intervent urġenti indikat]
English: In subjects with severe pre-existing hepatic impairment (Child-Pugh Class C) without cancer, the clearance of neratinib was decreased by 36% and exposure to neratinib increased by about 3-fold as compared to healthy volunteers.
Maltese: F'individwi b'indeboliment tal-fwied preeżistenti sever (Child Pugh Klassi C) mingħajr kanċer, it-tneħħija ta' neratinib tnaqqset b'36 % u lesponiment għal neratinib żdied b'madwar 3 darbiet meta mqabbel ma' voluntiera b'saħħithom.
English: Nerlynx 40 mg film-coated tablets
Maltese: Nerlynx 40 mg pilloli miksijin b'rita
English: • Grade 3 diarrhoea lasting between 2 days and 3 weeks‡
Maltese: • Dijarea ta' Grad 3 li ddum bejn jumejn u 3 ġimgħat‡
English: Do not use in children under 18 years of age.
Maltese: Tużax fi tfal taħt l-età ta' 18-il sena.
English: After discontinuation of a strong CYP3A4/P-gp inhibitor, resume previous dose of Nerlynx 240 mg (see Section 4.4 and Section 4.5).
Maltese: 40 mg) li tittieħed darba kuljum ma' inibitur qawwi ta' CYP3A4/Pgp. Wara t-twaqqif ta' inibitur qawwi ta' CYP3A4/Pgp, kompli d-doża preċedenti ta' Nerlynx ta' 240 mg (ara Sezzjoni 4.4 u Sezzjoni 4.5).