FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood or influence its effect (for example antifungals like ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John's Wort or proteasome inhibitors), talk to your doctor.
Maltese: • jekk qed tieħu mediċini oħra li jistgħu jżidu jew inaqqsu l-ammont ta' erlotinib fid-demm tiegħek jew jinfluwenzaw l-effett tiegħu (per eżempju kura kontra l-fungu bħal ketoconazole, inibituri ta' protease, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St.
English: What Tarceva contains:
Maltese: Tiħux Tarceva:
English: See sections 4.2, 4.4, 4.5 and 5.1.
Maltese: 4.4, 4.5, u 5
English: -Diarrhoea7 -Gastrointestinal bleeding4, 7
Maltese: -Fsada gastro intestinali4,7
English: INFORMATION IN BRAILLE tarceva 100 mg
Maltese: tarceva 100 mg
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Roche Registration GmbH.
English: Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class.
Maltese: Ir-reazzjonijiet avversi tal-mediċina minn provi kliniċi (Tabella 1) huma elenkati skont il-klassi tas sistemi u tal-organi MedDRA.
English: In the 45% of patients with known EGFR-expression status, the hazard ratio was 0.68 (95% CI 0.49-0.94) for patients with EGFR-positive tumours and 0.93 (95% CI 0.63-1.36) for patients with EGFR-negative tumours (defined by IHC using EGFR pharmDx kit and defining EGFR-negative as less than 10% tumour cells staining).
Maltese: F'45% tal-pazjenti li kien mgħaruf l-istat ta' espressjoni ta' EGFR, il-hazard ratio kien ta' 0.68 (95% CI 0.49-0.94) għall-pazjenti li kellhom tumuri posittivi għal EGFR u 0.93 (95% CI 0.63-1.36) għallpazjenti b' tumuri negattivi għal EGFR (iddefiniti minn IHC bl-użu ta' kitt EGFR pharmDx u b'EGFR-negattiv iddefinit bħala anqas minn 10% taċ-ċelluli tat-tumur jieħdu l-kulur).
English: Plasma protein binding is approximately 95%.
Maltese: Twaħħil mal-proteini fil-plażma kien ta' madwar 95%.
English: They are present in plasma at levels that are <10% of erlotinib and display similar pharmacokinetics as erlotinib.
Maltese: Huma preżenti fil-plażma f'livelli li huma <10% ta' erlotinib u juru farmakokinetika simili għal dik ta' erlotinib.
English: Exploratory Analysis (40% OS maturity) (n=173)
Maltese: (maturità ta' OS ta' 40%) (n=173)
English: Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 8.3% and 3% of patients, respectively, in study BO18192 and 5.6% and 2.8% of patients, respectively, in study BO25460.
Maltese: Modifiki fid-doża (interruzzjonijiet jew tnaqqis) għal raxx u dijarea kienu meħtieġa fi 8.3% u 3% tal-pazjenti, rispettivament, fl-istudju BO18192 u f'5.6% u 2.8% tal-pazjenti, rispettivament, fl-istudju BO25460.
English: In this study, the overall population showed a benefit for the primary PFS end-point (HR= 0.71 p< 0.0001) and the secondary OS end-point (HR= 0.81 p=0.0088).
Maltese: F'dan l-istudju, il-popolazzjoni globali wriet benefiċċju għall-punt finali primarju ta' PFS (HR= 0.71 p< 0.0001) u l-punt finali sekondarju ta' OS (HR= 0.81 p=0.0088).
English: The BO25460 (IUNO) study was conducted in 643 patients with advanced NSCLC whose tumors did not harbor an EGFR-activating mutation (exon 19 deletion or exon 21 L858R mutation) and who had not experienced disease progression after four cycles of platinum-based chemotherapy.
Maltese: L-istudju BO25460 (IUNO) twettaq fuq 643 pazjent b'NSCLC avanzat li t-tumuri tagħhom ma kellhomx mutazzjoni li tattiva lil EGFR (tneħħija ta' exon 19 jew mutazzjoni ta' exon 21 L858R) u li ma kellhomx progressjoni tal-marda wara erba' ċikli ta' kimoterapija bbażata fuq platinum.
English: In a Phase Ib study, there were no significant effects of gemcitabine on the pharmacokinetics of erlotinib nor were there significant effects of erlotinib on the pharmacokinetics of gemcitabine.
Maltese: Ib, la kien hemm effetti sinifikanti ta' gemcitabine fuq il-farmakokinetika ta' erlotinib, u lanqas effetti sinifikanti ta' erlotinib fuq il-farmakokinetika ta' gemcitabine.
English: In a post-hoc analysis, patients with favourable clinical status at baseline (low pain intensity, good QoL and good PS) may derive more benefit from Tarceva.
Maltese: F'analiżi post-hoc, pazjenti bi stat kliniku favorevoli fil-linja bażi (intensità ta' uġigħ baxxa, QoL tajjeb u PS tajjeb) jistgħu jieħdu aktar benefiċċju minn Tarceva.
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Maltese: Il-Ġermanja Manifattur Roche Pharma AG
English: Similarly, the exposure to the active metabolite increased by about 60% and 48% for AUC and Cmax, respectively.
Maltese: Bl-istess mod, l-espożizzjoni għall-metobolit attiv żdiedet b'madwar 60% u 48% għall-AUC u Cmax, rispettivament.
English: Progression Free Survival (PFS, median in months)* Investigator Assessed **
Maltese: Sopravivenza Mingħajr Progressjoni (PFS, medjan f'xhur)*
English: Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
Maltese: Tarceva 100 mg pilloli miksija b'rita Kull pillola miksija b'rita ta' 100 mg fiha 69.21 mg Lactose monohydrate.
English: Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor.
Maltese: Erlotinib huwa inibitur tar-riċettur tal-fattur ta' żvilupp epidermiku/ tar-riċettur tal-fattur ta' żvilupp epidermiku tip 1 uman (EGFR magħruf ukoll bħala HER1) tyrosine kinase.
English: The percent of patients alive at 12 months was 31.2% and 21.5%, for the Tarceva and placebo groups, respectively.
Maltese: Il-persentaġġ ta' pazjenti ħajjin wara 12-il xhar kien ta' 31.2% u 21.5%, fil-gruppi ta' Tarceva u tal-plaċebo, rispettivament.
English: The geometric mean of the AUC0-inf was 18726 ng•h/mL in the non-smokers and 6718 ng•h/mL in the smokers with a mean ratio of 35.9% (95% CI: 23.7 to 54.3, p < 0.0001).
Maltese: Il-medja ġeometrika ta' AUC0-inf kienet ta' 18726 ng•h/mL f'dawk li ma jpejpux u 6718 ng•h/mL f'dawk li jejpu b'ratio medju ta' 35.9% (95% CI: 23.7 sa' 54.3, p < 0.0001).
English: The primary metabolites OSI-420 and OSI-413 of erlotinib produced by O-demethylation of either side chain have comparable potency to erlotinib in non-clinical in vitro assays and in vivo tumour models.
Maltese: Ilmetaboliti prinċipali OSI-420 u OSI-413 ta' erlotinib riżultat ta' O-demethylation ta' waħda millkatini tal-ġnub għandhom qawwa komparabbli ma' erlotinib f'testijiet mhux kliniċi in vitro u mudelli tat-tumur in vivo.
English: Safety data were comparable between the 300 mg and 150 mg doses; however, there was a numerical increase in the incidence of rash, interstitial lung disease and diarrhoea, in patients receiving the higher dose of erlotinib (see sections 4.2, 4.4, 5.1 and 5.2).
Maltese: Id-data dwar is-sigurtà kienet paragunabbli bejn id-dożi ta' 300 mg u 150 mg; madankollu, kien hemm żieda numerika fl-inċidenza ta' raxx, marda tal-interstizju tal-pulmun u dijarea, f'pazjenti li jirċievu l-ogħla doża ta' erlotinib (ara sezzjonijiet 4.2, 4.4, 5.1 u 5.2).
English: ADRs occurring in ≥ 10% of patients in BR.21 (treated with Tarceva) and PA.3 (treated with Tarceva plus gemcitabine) studies and ADRs occurring more frequently (≥ 3%) than placebo in BR.21 (treated with Tarceva) and PA.3 (treated with Tarceva plus gemcitabine) studies Tarceva (BR.21) N = 485
Maltese: ADRs li seħħew f'≥ 10% tal-pazjenti fl-istudji BR.21 (ittrattati b'Tarceva) u PA.3 (ittrattati b'Tarceva flimkien ma' gemcitabine) u ADRs li seħħew b'mod aktar frekwenti (≥ 3%) millplaċebo fl-istudji BR.21 (ittrattati b'Tarceva) u PA.3 (ittrattati b'Tarceva flimkien ma' gemcitabine)
English: Therefore, caution should be used when erlotinib is combined with a potent CYP3A4 inhibitor, e.g. azole antifungals (i.e. ketoconazole, itraconazole, voriconazole), protease inhibitors, erythromycin or clarithromycin.
Maltese: Għalhekk, l-użu ta' erlotinib flimkien ma' inibitur qawwi ta' CYP3A4 e.ż. azole antifungals (ketoconazole, itraconazole, voriconazole), inibituri tal-protease, erythromycin jew clarithromycin, trid issir b'attenzjoni.
English: The median overall survival was 6.7 months in the Tarceva group (95% CI, 5.5 to 7.8 months) compared with 4.7 months in the placebo group (95% CI, 4.1 to 6.3 months).
Maltese: Is-sopravivenza totali medjana kienet ta' 6.7 xhur fil-grupp b'Tarceva (95% CI, 5.5 sa' 7.8 xhur) meta mqabbel ma' 4.7 xhur filgrupp bil-plaċebo (95% CI, 4.1 sa' 6.3 xhur).
English: Chronic dosing effects observed in at least one animal species or study included effects on the cornea (atrophy, ulceration), skin (follicular degeneration and inflammation, redness, and alopecia), ovary (atrophy), liver (liver necrosis), kidney (renal papillary necrosis and tubular dilatation), and gastrointestinal tract (delayed gastric emptying and diarrhoea).
Maltese: Effetti kroniċi ta' dożaġġ, osservati ta' l-inqas fi speċi ta' annimali waħda jew fi studju, inkludew effetti fuq il-korneja (atrofija, ulċerazzjoni), ġilda (deġenerazzjoni follikulari u infjammazjoni, ħmura u twaqqigħ tax-xahar), ovarji (atrofija), fwied (nekrożi tal-fwied), kliewi ( nekrozi papillari tal-kliewi u dilatazzjoni tat-tubi), u fil-passaġġ gastro-intestinali (l-istonku jdum aktar biex jitbattal u dijarea).
English: These were very common in clinical study PA.3 and common in clinical study BR.21.
Maltese: Dawn kienu komuni ħafna fl-istudju kliniku PA.3 u komuni fl-istudju kliniku BR.21.
English: PFS (median in months)
Maltese: PFS (medjan f'xhur)
English: Placebo (months)
Maltese: Plaċebo (xhur)
English: Erlotinib has a mean apparent volume of distribution of 232 l and distributes into tumour tissue of humans.
Maltese: Erlotinib għandu volum medju ta' distribuzzjoni apparenti ta' 232 l u jiddistribwixxi ruħu fit-tessut tattumur fil-bnedmin.
English: How to store Tarceva
Maltese: Tarceva +
English: 3 Including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumours (see section 4.4).
Maltese: 3 Inkluż imwiet, f'pazjenti li rċevew Tarceva għall-kura ta' NSCLC jew tumuri solidi avanzati oħra (ara sezzjoni 4.4).
English: In a clinical study, the concomitant use of erlotinib with ketoconazole (200 mg orally twice daily for 5 days), a potent CYP3A4 inhibitor, resulted in an increase of erlotinib exposure (86% of AUC and 69% of Cmax).
Maltese: Fi studju kliniku, l-użu ta' erlotinib flimkien ma' ketoconazole (200 mg mill-ħalq darbtejn kuljum għal ħamest ijiem), inibitur qawwi ta' CYP3A4, wassal għal żieda fl-espożizzjoni ta' erlotinib (86% ta' AUC u 69% ta' Cmax).
English: • Reduced kidney function (when given outside the approved indications in combination with chemotherapy)
Maltese: • Funzjoni tal-kliewi mnaqqsa (meta jingħata barra mill-indikazzjonijiet approvati flimkien ma' kimoterapija)
English: Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
Maltese: Tarceva 150 mg pilloli miksija b'rita Kull pillola miksija b'rita ta' 150 mg fiha 103.82 mg Lactose monohydrate.
English: The median PFS was 9.7 weeks in the Tarceva group (95% CI, 8.4 to 12.4 weeks) compared with 8.0 weeks in the placebo group (95% CI, 7.9 to 8.1 weeks).
Maltese: Il-PFS medjan kien ta' 9.7 ġimgħat fil-grupp ta' Tarceva (95% CI, 8.4 sa' 12.4 ġimgħat) meta mqabbel ma' 8.0 ġimgħat fil-grupp tal-plaċebo (95% CI, 7.9 sa' 8.1 ġimgħat).
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Maltese: Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen
English: A higher incidence of ILD (approximately 5% with a mortality rate of 1.5%) is seen among patients in studies conducted in Japan.
Maltese: Inċidenza ogħla ta' ILD (madwar 5% b'rata ta' mortalità ta' 1.5%) hijaosservata fost pazjenti fi studji li twettqu fil-Ġappun.
English: -Corneal perforations -Corneal ulcerations -Uveitis
Maltese: • Każijiet ta' perforazzjoni jew ulċerazzjoni tal-korneja
English: The combination of Tarceva and a statin may increase the potential for statin-induced myopathy, including rhabdomyolysis, which was observed rarely.
Maltese: It-taħlita ta' Tarceva u statin tista' żżid il-potenzjal ta' mijopatija kkawżata minn statin, inkluż rabdomijolisi, li kienet osservata b'mod rari.
English: Suomi/Finland
Maltese: Suomi/Finland Roche Oy
English: (≥1/1,000 to
Maltese: Rari sa <1/1,000)
English: The incidence of adverse drug reactions (ADRs) from clinical trials reported with Tarceva alone or in combination with chemotherapy are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 1.
Maltese: L-inċidenza ta' reazzjonijiet avversi tal-mediċina (ADRs - adverse drug reactions) mill-provi kliniċi rrappurtata b'Tarceva waħdu jew flimkien ma' kimoterapija huma mogħtija fil-qosor skont il-Grad tan-National Cancer Institute-Common Toxicity Criteria (NCI-CTC) fit-Tabella 1.
English: - Maintenance NSCLC therapy after first-line chemotherapy (Tarceva administered as monotherapy)
Maltese: - Terapija ta' manteniment għal NSCLC wara kimoterapija preferita (Tarceva mogħti bħala monoterapija)
English: The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT> 5 x ULN).
Maltese: Is-sigurtà u l-effikaċja ta' erlotinib ma kienux studjati f'pażjenti b'disfunzjoni severa tal-fwied (AST/SGOT u ALT/SGPT > 5 x ULN).
English: Date of first authorization: 19 September 2005 Date of latest renewal: 2 July 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' Settembru 2005
English: In another clinical study, erlotinib was shown not to affect pharmacokinetics of the concomitantly administered CYP3A4/2C8 substrate paclitaxel.
Maltese: Fi studju kliniku ieħor, erlotinib intwera li ma affettwax il-farmakokinetika ta' paclitaxel, susbtrat ta' CYP3A4/2C8, mogħti fl-istess ħin.
English: Although the Cmax was statistically significant lower in moderately hepatic impaired patients, this difference is not considered clinically relevant.
Maltese: Għalkemm f'pazjenti b'indeboliment moderat tal-fwied Cmax kienet inqas b'mod sinifikanti statistikament, din id-differenza mhux ikkunsidrata ta' rilevanza klinika.
English: Erlotinib and P-glycoprotein inhibitors
Maltese: Erlotinib u inibituri ta' P-glycoprotein
English: A population pharmacokinetic analysis in 591 patients receiving single agent Tarceva shows a mean apparent clearance of 4.47 l/hour with a median half-life of 36.2 hours.
Maltese: Analiżi tal-farmakokinetika ta' popolazzjoni f'591 pazjent li ngħataw Tarceva waħdu wriet medja apparenti ta' tneħħija ta' 4.47 l/siegħa b' half-life medjana ta' 36.2 sigħat.
English: This corresponded to an overall average of 63% (range 5-161%) of the steady state observed peak plasma concentrations.
Maltese: Dan jikkorrispondi għall-medja totali ta' 63% (firxa 5161%) ta' l-għola konċentrazzjonijiet fil-plażma osservati fi stat stabbli.
English: In a clinical study, the concomitant use of erlotinib and rifampicin (600 mg orally once daily for 7 days), a potent CYP3A4 inducer, resulted in a 69% decrease in the median erlotinib AUC.
Maltese: Fi studju kliniku, l-użu ta' erlotinib flimkien ma' rifampicin (600 mg mill-ħalq darba kuljum għal sebat ijiem), induttur qawwi ta' CYP3A4, wassal għal tnaqqis ta' 69% fl-AUC medjan ta' erlotinib.
English: Erlotinib is a potent inhibitor of CYP1A1, and a moderate inhibitor of CYP3A4 and CYP2C8, as well as a strong inhibitor of glucuronidation by UGT1A1 in vitro.
Maltese: Elotinib huwa inibitur qawwi ta' CYP1A1, u inibitur moderat ta' CYP3A4 u CYP2C8, kif wkoll huwa inibitur b'saħħtu ta' glukuronidazzjoni minn UGT1A1 in vitro.
English: Tarceva contains a sugar called lactose monohydrate.
Maltese: Tarceva fih zokkor li jissejjaħ lactose monohydrate.
English: Erlotinib and proteasome inhibitors
Maltese: Erlotinib u inibituri ta' proteasome
English: Tarceva should be permanently discontinued in patients who develop gastrointestinal perforation (see section 4.8).
Maltese: Tarceva għandhu jitwaqqaf b'mod permanenti f'pazjenti li jiżviluppaw perforazzjoni gastro-intestinali (ara sezzjoni 4.8).
English: Reduced exposure may also occur with other inducers e.g. phenytoin, carbamazepine, barbiturates or St. John's Wort (hypericum perforatum).
Maltese: Espożizzjoni mnaqqsa tistà tiġri wkoll b'indutturi oħra e.ż. phenytoin, carbamazepine, barbiturates jew St.
English: For the different dose regimens Tarceva is available in strengths of 25 mg, 100 mg or 150 mg.
Maltese: Għal korsijiet ta' dożi differenti Tarceva huwa disponibbli f'qawwiet ta' 25 mg, 100 mg jew 150 mg.
English: Tarceva 25 mg film-coated tablets Tarceva 100 mg film-coated tablets Tarceva 150 mg film-coated tablets Erlotinib
Maltese: Informazzjoni għall-utent Tarceva 25 mg pilloli miksija b'rita Tarceva 100 mg pilloli miksija b'rita Tarceva 150 mg pilloli miksija b'rita
English: The safety and efficacy of erlotinib has not been studied in patients with renal impairment (serum creatinine concentration >1.5 times the upper normal limit).
Maltese: Is-sigurtà u l-effikaċja ta' erlotinib ma kienux studjati f'pazjenti b'indeboliment tal-kliewi (konċentrazzjoni tal-krejatinina fis-serum >1.5 drabi l-għola livell normali).
English: In patients with solid tumours and with moderately impaired hepatic function (Child-Pugh score 7-9), geometric mean erlotinib AUC0-t and Cmax was 27000 ng•h/mL and 805 ng/mL, respectively, as compared to 29300 ng•h/mL and 1090 ng/mL in patients with adequate hepatic function including patients with primary liver cancer or hepatic metastases.
Maltese: 27000 ng•h/mL u 805 ng/mL, rispettivament, kif imqabbel ma' 29300 ng•h/mL u 1090 ng/mL f'pazjenti b'funzjoni tal-fwied adegwata, inkluż pazjenti b'kanċer primarju tal-fwied jew b'metastasi fil-fwied.
English: Patients were randomised 1:1 to receive Tarceva 150 mg daily or up to 4 cycles of platinum based doublet chemotherapy.
Maltese: Il-pazjenti kienu randomised 1:1 biex jirċievu Tarceva 150 mg kuljum jew sa 4 ċikli ta' kimoterapija doublet ibbażata fuq platinum.
English: The primary endpoint was overall survival.
Maltese: Il-punt finali primarju kien is-sopravivenza totali.
English: Baseline
Maltese: Erlotinib
English: -Paronychia -Folliculitis -Acne/
Maltese: -Paronikja -Follikulite
English: Bullous, blistering and exfoliative skin conditions have been reported, including very rare cases suggestive of Stevens-Johnson syndrome/Toxic epidermal necrolysis, which in some cases were fatal (see section 4.8).
Maltese: Kienu rrapportati kundizzjonijiet bullużi, bl-infafet u bil-qxur, inkluż każijiet rari ħafna li jissuġġerixxu s-sindrome Stevens-Johnson/Nekroliżi epidermali tossika, li f'xi każijiet kienu fatali (ara sezzjoni 4.8).
English: The effects of concomitant administration of erlotinib with H2 antagonists and antacids are unknown; however, reduced bioavailability is likely.
Maltese: L-effetti ta' l-għotja ta' erlotinib flimkien ma' antagonisti ta' H2 u antaċidi mhumiex magħrufa; iżda, biodisponibiltà mnaqqsa hija probabbli.
English: Hypersensitivity to erlotinib or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal erlotinib jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate.
Maltese: Tarceva 25 mg pilloli miksija b'rita Kull pillola miksija b'rita ta' 25 mg fiha 27.43 mg Lactose monohydrate.
English: The inhibition of glucuronidation may cause interactions with medicinal products which are substrates of UGT1A1 and exclusively cleared by this pathway.
Maltese: L-inibizzjoni ta' glukuronidazzjoni tista' tikkawża interazzjonijiet ma' prodotti mediċinali oħra li huma substrati ta' UGT1A1 u jitneħħew esklusivament permeżż ta' dan il-passaġġ.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Maltese: Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen
English: The median time to onset of rash and diarrhoea was 10 days and 15 days, respectively.
Maltese: Iż-żmien medjan sal-bidu ta' raxx u dijarea kien ta' 10 ijiem u 15-il jum, rispettivament.
English: Co-administration of rifampicin with a single 450 mg dose of Tarceva resulted in a mean erlotinib exposure (AUC) of 57.5% of that after a single 150 mg Tarceva dose in the absence of rifampicin treatment.
Maltese: L-għotja flimkien ta' rifampicin ma' doża waħda ta' 450 mg ta' Tarceva wassal għal espożizzjoni medja għal erlotinib (AUC) ta' 57.5% ta' dik wara doża waħda ta' 150 mg ta' Tarceva fin-nuqqas ta' kura b'rifampicin.
English: In an open-label, randomised phase III study, ML20650 conducted in 154 patients, the safety of Tarceva for first-line treatment of NSCLC patients with EGFR activating mutations was assessed in 75 patients; no new safety signals were observed in these patients.
Maltese: III open-label u randomised, ML20650, li sar fuq 154 pazjent, is-sigurtà ta' Tarceva għat-trattament tal-ewwel għażla ta' pazjenti b'NSCLC b'mutazzjonijiet li jattivaw lil EGFR kienet evalwata f'75 pazjent; ma kinux osservati sinjali ta' sigurtà ġodda f'dawn il-pazjenti.
English: -Rash
Maltese: -Raxx
English: Potent inducers of CYP3A4 activity increase erlotinib metabolism and significantly decrease erlotinib plasma concentrations.
Maltese: Indutturi potenti ta' l-attività ta' CYP3A4 iżidu l-metaboliżmu ta' erlotinib u sinnifikament inaqqsu lkonċetrazzjoni ta' erlotinib fil-plażma.
English: Grade 3 rash and diarrhoea occurred in 9% and 4% of patients, respectively.
Maltese: Raxx u dijarea ta' Grad 3 seħħew f'9% u 4% tal-pazjenti, rispettivament.
English: Patients were randomised to receive Tarceva or placebo once daily on a continuous schedule plus gemcitabine IV (1000 mg/m2, Cycle 1 - Days 1, 8, 15, 22, 29, 36 and 43 of an 8 week cycle; Cycle 2 and subsequent cycles - Days 1, 8 and 15 of a 4 week cycle [approved dose and schedule for pancreatic cancer, see the gemcitabine SPC]).
Maltese: Il-pazjenti kienu magħżula bladdoċċ biex jingħataw Tarceva jew plaċebo darba kuljum fuq skeda kontinwa flimkien ma' gemcitabine IV (1000 mg/m2, Ċiklu 1 - Ġranet 1, 8, 15, 22, 29, 36 u 43 ta' ċiklu ta' 8 ġimgħat;
English: No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumours (see section 5.1).
Maltese: F'pazjenti b'tumur negattivi għar-Riċettur tal-Fattur ta' Żvilupp Epidermali (EGFR)-IHC ma ntwerewx benefiċċju ta' sopravivenza jew effetti oħra tal-kura ta' rilevanza klinika (ara sezzjoni 5.1).
English: Diarrhoea, dehydration, electrolyte imbalance and renal failure Diarrhoea (including very rare cases with a fatal outcome) has occurred in approximately 50% of patients on Tarceva and moderate or severe diarrhoea should be treated with e.g. loperamide.
Maltese: Dijarea, deidrazzjoni, żbilanċ fl-elettroliti u insuffiċjenza renali Dijarea (inkluż każijiet rari ħafna b'riżultat fatali) seħħet f'madwar 50% tal-pazjenti fuq Tarceva u dijarea moderata jew qawwija għandha tiġi kkurata b' eż. loperamide.
English: n=77
Maltese: Awwissu n=77
English: The tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Maltese: Il-pilloli fihom lactose u m'għandhomx jingħataw lill-pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose.