FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8).
Maltese: Ġew osservati abnormalitajiet fit-test tal-funzjoni tal-fwied (inkluż żidiet fl-alanine aminotransferase, aspartate aminotransferase, bilirubin) liippreżentaw ruħhom b'mod mhux komuni bħala epatite (ara sezzjoni 4.8).Kien hemm rapporti iżolati ta' insuffiċjenza epatika li f'xi każijiet wasslet għal riżultati fatali.
English: Population
Maltese: Reżistenza
English: Interstitial lung disease (1.3%), often severe (CTC grade 3-4).
Maltese: Mard interstizjali tal-pulmun (1.3 %), bosta drabi qawwi (CTC grad 3-4).
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows:
Maltese: Reazzjonijiet avversi mhux osservati fi studji kliniċi, iżda osservati fl-annimali, fil-livelli ta' esponiment simili għal livelli ta' esponiment kliniku u ta' relevanza potenzjali għall-użu kliniku kienu kif ġej:
English: Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort/ Hypericum perforatum) should be avoided.
Maltese: Prodotti mediċinali li jingħataw flimkien u li jinduċu CYP3A4 (eż phenytoin, carbamażepine, rifampiċina, barbiturati u St.
English: Histology <0.0001 4.4 times higher in adenocarcinoma than in non-adenocarcinoma
Maltese: <0.0001 4.4 drabi ogħla f'adenokarċinoma milli f'non-adenokarċinoma
English: Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Maltese: Kura minn qabel b'itraconazole (inibitur qawwi ta' CYP3A4) irriżultat f'żieda ta' 80% fl-AUC medja ta' gefitinib f'voluntiera b'saħħithom.
English: Data from non-clinical (in vitro) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarisation process (e.g. QT interval).
Maltese: Dejta minn studji mhux kliniċi (in vitro) indikat li gefitinib għandu potenzjal li jinibixxi l-proċess ta' ripolarizzazzjoni tal-potenzjal tal-azzjoni kardijaku (eżempju intervall QT).
English: There are no data on concomitant treatment with an inhibitor of CYP2D6 but potent inhibitors of this enzyme might cause increased plasma concentrations of gefitinib in CYP2D6 extensive metabolisers by about 2-fold (see section 5.2).
Maltese: Ma hemmx dejta ta' meta jingħata flimkien ma' inibituri ta' CYP2D6, iżda inibituri qawwija ta' din lenzima jistgħu jżidu l-konċentrazzjonijiet ta' gefitinib fil-plasma ta' metabolizzaturi estensivi ta' CYP2D6, b'darbtejn (ara sezzjoni 5.2).
English: The dispersion can also be administered through a naso-gastric or gastrostomy tube.
Maltese: Id-dispersjoni tista' tiġi amministrata ukoll minn tubu naso-gastriku jew talgastrostomija.
English: Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 IRESSA-treated patients).
Maltese: Reazzjonijiet avversi kienu assenjati skont il-kategoriji talfrekwenza f'Tabella 1 fejn possibbli bbażati fuq l-inċidenza ta' rapporti ta' avvenimenti avversi komparabbli miġbura f'sett ta' dejta minn provi kliniċi ta' fażi III ISEL, INTEREST u IPASS (2462 pazjent ikkurat b'IRESSA).
English: HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Maltese: għal sopravivenza totali HR fil-popolazzjoni totali, jew inkella 95% intervall ta' fiduċja għal HR c Intervall ta' fiduċja kompletament taħt il-marġini ta' non-inferjorità ta' 1.154
English: The formation of O-desmethyl gefitinib has been shown, in vitro, to be via CYP2D6.
Maltese: Intwera li l-formazzjoni ta' O-desmethyl gefitinib, in vitro, kienet permezz ta' CYP2D6.
English: This resulted in a 35% increase in exposure to metoprolol.
Maltese: Dan irriżulta f'żieda ta' 35% flesponiment għal metoprolol.
English: In a clinical trial in patients, gefitinib was co-administered with metoprolol (a CYP2D6 substrate).
Maltese: Fi prova klinika f'pazjenti, gefitinib ingħata ma' metoprolol (sottostrat ta' CYP2D6).
English: Administration of gefitinib once daily results in 2- to 8-fold accumulation, with steady state exposures achieved after 7 to 10 doses.
Maltese: Amministrazzjoni ta' gefitinib darba kuljum tirriżulta f'akkumulazzjoni minn 2 sa 8 darbiet aktar bi stat fiss ta' esponimenti jintlaħaq wara 7 sa 10 dożi.
English: Anorexia mild or moderate (CTC grade 1 or 2)
Maltese: Anoressija, ħafifa jew moderata (CTC grad 1 jew 2)
English: AstraZeneca AB SE-151 85
Maltese: AstraZeneca AB Gärtunavägen SE-151 85
English: In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86).
Maltese: F'dak l-istudju, intuża ctDNA miksub minn serum, mhux mill-plasma għal analiżi tal-mutazzjoni ta' EGFR permezz ta' Kitt ta' Test ta' Mutazzjoni ta' EGFR (DxS) (N= 86).
English: Therefore, concomitant administration of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum) may reduce efficacy of the treatment and should be avoided (see section 4.5).
Maltese: Għalhekk amministrazzjoni konġunta ta' sustanzi li jżidu lattività ta' CYP3A4 (bħal; phenytoin, carbamazepine, rifampiċin, barbiturati jew preparazzjonijiet mill-ħxejjex li fihom St John's Wort/Hypericum perforatum) jistgħu jnaqqsu mill-effikaċja tal-kura u għandhom jiġu evitati (ara sezzjoni 4.5)
English: In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%.
Maltese: Fi studju ta' sorveljanza ta' wara tqegħid fis-suq fil-Ġappun (3350 pazjent) ir-rata ta' avvenimenti ta' ILD f'pazjenti li ngħataw gefitinib kien ta' 5.8%.
English: Gefitinib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown.
Maltese: Gefitinib jinibixxi l-proteina trasportatur BCRP in vitro iżda r-relevanza klinika ta' din is-sejba mhix magħrufa.
English: N Objective response rates and 95% CI for difference between treatments
Maltese: N Rati Oġġettivi tarrispons u CI ta' 95% għaddifferenza bejn ittrattamenti
English: In a phase I/II trial studying the use of gefitinib and radiation in paediatric patients, with newly diagnosed brain stem glioma or incompletely resected supratentorial malignant glioma, 4 cases (1 fatal) of Central Nervous System (CNS) haemorrhages were reported from 45 patients enrolled.
Maltese: I/II li tistudja l-użu ta' gefitinib u radjazzjoni f'pazjenti pedjatriċi li għadu kif instabitilhom glijoma fiz-zokk ċentrali tal-moħħ jew glijoma malinna supratentorjali mhux imneħħija kompletament ġew irrappurtati 4 każijiet (1 fatali) ta' emorraġija tas-Sistema Ċentrali Nervuża (CNS, Central Nervous System) fost il-45 pazjent reġistrat.
English: IRESSAcontains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor' (EGFR).
Maltese: IRESSA fih is-sustanza attiva gefitinib li tibblokka proteina msejħa riċettur tal-fattur tat-tkabbir epidermali (EGFR, epidermal growth factor receptor).
English: In a Japanese pharmacoepidemiological case control study in 3,159 patients with NSCLC receiving gefitinib or chemotherapy who were followed up for 12 weeks, the following risk factors for developing ILD (irrespective of whether the patient received IRESSA or chemotherapy) were identified: smoking, poor performance status (PS ≥ 2), CT scan evidence of reduced normal lung (≤ 50%), recent diagnosis of NSCLC (< 6 months), pre-existing ILD, older age (≥ 55 years old) and concurrent cardiac disease.
Maltese: Fi studju farmakoepidemjoloġiku Ġappuniż ta' kontroll tal-każ (case control) fi 3,159 pazjent b'NSCLC u li kienu qed jirċievu gefitinib jew kimoterapija u li ġew segwiti għal 12-il ġimgħa, ġew identifikati l-fatturi ta' riskju li ġejjin għall-iżvilupp ta' ILD (irrispettivament minn jekk il-pazjent kienx qed jirċievi IRESSA jew kimoterapija): tipjip, status ta' prestazzjoni dgħajfa (PS ≥ 2), evidenza b'CT scan ta' tiċkin ta' pulmun normali (<50%), dijanjosi reċenti ta' NSCLC (< 6 xhur), ILD preeżistenti, età akbar (≥ 55 sena), u mard tal-qalb fl-istess ħin.
English: 42.9 v. 20.0 EGFR Mutation+
Maltese: 42.9 v. 20.0
English: The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium laurilsulfate, magnesium stearate, hypromellose (E464), macrogol 300, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
Maltese: L-ingredjenti l-oħra (eċċipjenti) huma lactose monohydrate, microcrystalline cellulose (E460), croscarmellose sodium, povidone (K29-32) (E1201), sodium laurilsulfate, magnesium stearate,
English: Diarrhoea, mainly mild or moderate (CTC grade 1 or 2) Vomiting, mainly mild or moderate (CTC grade 1 or 2) Nausea, mainly mild (CTC grade 1)
Maltese: Dijarrea, l-aktar ħafifa jew moderata (CTC grad 1 jew 2) Rimettar, l-aktar ħafif jew moderat (CTC grad 1 jew 2) Dardir, l-aktar ħafif (CTC grade 1) Stomatite ta' predominanza ħafifa (CTC grad 1)
English: **This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.
Maltese: **Din tinkludi rapporti iżolati ta' indeboliment tal-fwied li f'xi każijiet wassal għal riżultati fatali.
English: Risk of mortality among patients who developed ILD on IRESSA or chemotherapy was higher in patients with the following risk factors: smoking, CT scan evidence of reduced normal lung (≤ 50%), pre-existing ILD, older age (≥ 65 years old), and extensive areas adherent to pleura (≥ 50%).
Maltese: Irriskju ta' mortalità fost pazjenti li żviluppaw ILD waqr li kienu fuq IRESSA jew kimoterapija kien ogħla f'pazjenti b'dawn il-fatturi ta' riskju li ġejjin: tipjip, evidenza b'CT scan ta' tiċkin ta' pulmun normali (< 50 %), ILD pre-eżistenti, età akbar (≥ 65 sena), u żoni estensivi aderenti mal-plewra ( ≥
English: IRESSA is a round brown tablet marked with ‘IRESSA 250' on one side and plain on the other.
Maltese: IRESSA hija pillola kannella, tonda, immarkata “IRESSA 250” fuq naħa waħda u xejn fuq in-naħa loħra.
English: In about 60% of cases, resistance is associated with a secondary T790M mutation for which T790M targeted EGFR TKIs may be considered as a next line treatment option.
Maltese: F'madwar 60% tal-każijiet, ir-reżistenza hija assoċjata ma' mutazzjoni T790M sekondarja li għaliha TKIs tal-EGFR immirati għal T790M jistgħu jitqiesu bħala għażla ta' kura li jmiss.
English: In a phase III open-label clinical trial (IPASS) in 1217 patients comparing IRESSA to carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced NSCLC in Asia, the incidence of ILD-type events was 2.6% on the IRESSA treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
Maltese: III open label (IPASS) f'1217-il pazjent fejn IRESSA tqabblet ma' kimoterapija doppja b'carboplatin/paclitaxel bħala l-ewwel kura f'pazjenti b'NSCLC fl-Asja, linċidenza ta' avvenimenti tat-tip ILD kienet ta' 2.6% fil-fergħa tal-kura b'IRESSA meta mqabbel ma' 1.4% fil-fergħa tal-kura carboplatin/paclitaxel.
English: Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Maltese: Meta gefitinib jingħata ma' ranitidine f'doża li tikkawża elevazzjoni sostnuta tal-pH gastriku ta' ≥ 5 dan irriżulta fi tnaqqis tal-AUC medja ta' gefitinib ta' 47 % f'voluntiera b'saħħithom (ara sezzjoni 4.4 u 5.2)
English: Gefitinib is extensively metabolised in humans.
Maltese: Gefitinib huwa metabolizzat b'mod estensiv fil-bniedem.
English: At initiation of treatment with a CYP3A4 inhibitor, patients should be closely monitored for gefitinib adverse reactions (see section 4.5).
Maltese: Fil-bidu tal-kura b'inibitur CYP3A4, il-pazjenti għandhom jiġu segwiti mill-qrib għal reazzjonijiet avversi ta' gefitinib (ara sezzjoni 4.5).
English: Following oral administration of C-14 labelled gefitinib to lactating rats 14 days post-partum, concentrations of radioactivity in milk were 11-19 fold higher than in blood.
Maltese: Wara amministrazzjoni b'mod orali ta' gefitinib immarkat C-14 f'firien li qed ireddgħu, 14-il jum wara l-ħlas, il-konċentrazzjonijiet ta' radjoattività fil-ħalib kienu bejn 11 u 19-il darba ogħla milli fiddemm.
English: Numbers in square brackets are 95% confidence intervals for HR c Stratified log-rank test for overall; otherwise cox proportional hazards model d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth
Maltese: Numri fil-parentesi kwadri huma 95% confidence intervals għall-HR c Log-rank test stratifikat għat-total; inkella l-mudell tal-perikli proporzjonali cox d Etniċità Ażjatika teskludi pazjenti ta' oriġini Indjana u tirreferi għall-oriġini razzjali tal-grupp tal-pazjent u mhux neċessarjament il-post tat-twelid.
English: Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme.
Maltese: Minn studji fuq annimali deher li gefitinib ma jżidx l-attività tal-enzimi u ma kienx hemm inibizzjoni sinifikanti tal-attività (in vitro) ta' xi enzimi cytochrome P450 oħra.
English: Table 5 Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study
Maltese: Riżultati tal-effikaċja għal gefitinib versus docetaxel mill-istudju INTEREST
English: IRESSA contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free.'
Maltese: IRESSA fih inqas minn 1 mmol (23 mg) ta' sodium għal kull pillola, għalhekk jista' jitqies li huwa essenzjalment “mingħajr sodium”.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini. http://www.ema.europa.eu/.
English: The frequency of adverse drug reactions relating to abnormal laboratory values is based on patients with a change from baseline of 2 or more CTC grades in the relevant laboratory parameters.
Maltese: Il-frekwenza ta' reazzjonijiet avversi tal-mediċina relatati ma' valuri tal-laboratorju li huma abnormali, hija bbażata fuq pazjenti b'tibdil minn linja bażi ta' 2 jew aktar fil-grad CTC skont parametri tal-laboratorju relevanti.
English: Gefitinib is a selective small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase and is an effective treatment for patients with tumours with activating mutations of the EGFR tyrosine kinase domain regardless of line of therapy.
Maltese: Gefitinib huwa inibittur selettiv tal-molekuli żgħartar-reċettur tal-fattur tat-tkabbir epidermali tyrosine kinase u huwa kura effettiva għal pazjenti b'tumuri b'mutazzjonijiet attivanti tad-domain ta' EGFR tyrosine kinase irrispettivament mil-linja ta' terapija.
English: Haemorrhagic cystitis
Maltese: Mhux Ażjatiċi
English: Elevations in alanine aminotransferase, mainly mild to moderate
Maltese: Żidiet ħfief jew moderati ta' alanine aminotransferase
English: Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that gefitinib is a substrate of p-glycoprotein (Pgp).
Maltese: Sustanzi attivi li jistgħu jżidu l-konċentrazzjonijiet ta' gefitinib fil-plasma Studji in vitro urew li gefitinib huwa sottostrat ta' p-glycoprotein (Pgp).
English: Drink the liquid straight away.
Maltese: Tużax likwidi oħra.
English: Pyrexia
Maltese: Docetaxel
English: In the IFUM trial, mutation status was assessed in tumour and ctDNA samples derived from plasma, using the Therascreen EGFR RGQ PCR kit (Qiagen).
Maltese: Fil-prova tal-IFUM, l-istatus ta' mutazzjoni ġie vvalutat f'kampjuni ta' tumuri u ta' ctDNA miksubin mill-plasma, permezz tal-kitt Therascreen EGFR RGQ PCR (Qiagen).
English: Table 4 Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Maltese: Tabella 4 Riżultati tal-kwalità tal-ħajja għal gefitinib versus carboplatin/paclitaxel mill-istudju IPASS
English: Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Maltese: Tabella 6 Riżultati tal-effikaċja għal gefitinib versus plaċebo mill-istudju ISEL
English: Other potential interactions
Maltese: Interazzjonijiet potenzjali oħra
English: Each tablet contains 250 mg gefitinib.
Maltese: Kull pillola fiha 250 mg gefitinib.
English: Corneal epithelia atrophy and corneal translucencies Renal papillary necrosis
Maltese: Atrofija epiteljali tal-kornea u transluċenti tal-kornea Nekrosi papillari renali
English: Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Maltese: Sustanzi attivi li jista'jkollhom il-konċentrazzjonijiet fil-plasma alterati minn gefitinib Studji in vitro urew li gefitinib għandu potenzjal limitat sabiex jinibixxi CYP2D6.
English: A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Maltese: Tnaqqis fil-fertilità kien osservat fil-firien nisa b'doża ta' 20 mg/kg/jum
English: Dry mouth*, predominantly mild (CTC grade 1)
Maltese: Ħalq xott *, ta' predominanza ħafifa (CTC grad 1)
English: Table 3 Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Maltese: Tabella 3 Riżultati tal-effikaċja għal gefitinib versus carboplatin/paclitaxel mill-istudju IPASS
English: From analyses of population pharmacokinetic data in cancer patients, no relationships were identified between predicted steady-state trough concentration and patient age, body weight, gender, ethnicity or creatinine clearance (above 20 ml/min).
Maltese: Minn analiżi ta' dejta farmakokinetika tal-popolazzjoni ta' pazjenti bil-kanċer, ma kienx hemm l-ebda relazzjoni identifikata bejn konċentrazzjoni mbassra fi stat fiss u l-età tal-pazjent, il-piż, sess, ġens u eliminazzjoni ta' kreatinina (aktar minn 20 mgl/min).
English: Concomitant administration with potent inhibitors of CYP3A4 activity (e.g. ketoconazole, posaconazole, voriconazole, protease inhibitors, clarithromycin, telithromycin) may increase gefitinib plasma concentrations.
Maltese: (eż. ketoconazole, posaconazole, voriconazole, inibituri talprotease, clarithromycin, telithromycin) jista' jżid il-konċentrazzjonijiet ta' gefitinib fil-plasma.
English: Patients with poorly tolerated diarrhoea or skin adverse reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement of the 250 mg dose (see section 4.8).
Maltese: Pazjenti li ma jifilħux għall-effetti tad-dijarrea jew b'reazzjonijiet avversi fil-ġilda jistgħu jiġu kkontrollati b'suċċess billi tiġi pprovduta interruzzjoni qasira fit-terapija (sa 14-il ġurnata) segwita mill-ġdid b'doża ta' 250 mg (ara sezzjoni 4.8).
English: EGFR mutation-negative
Maltese: Mutazzjoni negattiva ta' EGFR
English: Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration.
Maltese: Meta jittieħed mill-ħalq, l-assorbiment ta' gefitinib huwa moderatament bil-mod u l-ogħla konċentrazzjoni ta' gefitinib fil-plasma tidher minn 3 sa 7 sigħat wara li tiġi amministrata.
English: 1317 5.3% vs 1.6%
Maltese: Dejjem kien ipejjep 1317 5.3% vs 1.6%
English: In vitro data indicate that CYP3A4 and CYP2D6 are the major P450 isozyme involved in the oxidative metabolism of gefitinib.
Maltese: Minn tagħrif in vitro jidher li CYP3A4 u CYP2D6 huma l-aktar isoenzimi P450 li għandhom x'jaqsmu mal-metaboliżmu li jossida l-gefitinib.
English: LCS symptom improvement rate
Maltese: GĦAMLA KWALITATTIVA
English: Medicinal products that cause significant sustained elevation in gastric pH, such as proton-pump inhibitors and h2-antagonists may reduce bioavailability and plasma concentrations of gefitinib and, therefore, may reduce efficacy.
Maltese: Prodotti mediċinali li jgħollu b'mod sinifikanti u sostnut il-pH gastriku, bħal inibituri proton-pump u antagonisti ta' h2 jistgħu jnaqqsu l-bijodisponibilità u l-konċentrazzjonijiet fil-plasma ta' gefitinib u b'hekk tonqos l-effikaċja.
English: Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1)
Maltese: Konġuntivite, blefarite, u għajnejn xotti*, l-aktar ħfief (CTC grad 1)
English: This increase in exposure may be of clinical relevance since adverse experiences are related to dose and exposure to gefitinib.
Maltese: Iżżieda tista' tkun klinikament relevanti peress li r-reazzjonijiet avversi huma relatati mad-doża u lesponiment.
English: The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' IRESSA fit-tfal u l-adolexxenti ta' anqas minn 18-il sena ma ġewx determinati s'issa.
English: The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes).
Maltese: Id-dispersjoni għandha tinxtorob minnufih wara li ddispersjoni tkun lesta (jiġifieri fi żmien 60 minuta).
English: Stomatitis, predominantly mild in nature (CTC grade 1)
Maltese: Nuqqas ta' enerġija, bi predominanza ħafifa (CTC grad 1)
English: CYP2D6 poor metabolisers
Maltese: Metabilizzaturi dgħajfin ta' CYP2D6
English: IRESSA 250 mg film-coated tablets gefitinib
Maltese: IRESSA 250 mg, pilloli miksija b'rita gefitinib
English: Table 2 Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
Maltese: Tabella 2: Sommarju tal-istatus ta' mutazzjoni tal-linja bażi għall-kampjuni ta' tumuri u ctDNA fil-pazjenti skrinjati kollha evalwabbli għaż-żewġ kampjuni.
English: Hair loss
Maltese: FLOW WRAP
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/ALUMINIUM FOIL LAMINATE FLOW WRAP
Maltese: Tliet strixxi huma ikkombinati b'fojl tal-aluminju laminat over- wrap ġewwa kartuna
English: Film-coated tablets (tablet).
Maltese: Tfarrakx il-pillola.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Maltese: Studji in vitro juru li gefitinib jista' jnaqqas l-attività ta' CYP2D6 b'mod limitat.
English: EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7).
Maltese: Karatteristiċi kliniċi ta' min qatt ma pejjep, istoloġija ta'adenokarċinoma u ġeneru femminili urew li huma fatturi indipendenti li jbassru l-istatus pożittiv ta' mutazzjoni ta' EGFR f'analiżi multivarjanti ta' 786 pazjent Kawkasu minn studji b'gefitinib
English: No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min.
Maltese: Ma hemmx bżonn ta' tibdil fid-doża f'pazjenti b'indeboliment fil-funzjoni renali, bi tneħħija talkrejatinina ta' > 20 ml/min.
English: Overall survival a,b
Maltese: L-endpoint primarju Sopravivenza mingħajr progressjoni a,b
English: Progression free survival ab
Maltese: Sopravivenza mingħajr progressjoni ab