FrancophonIA/ELRC3.0 huggingface dataset:
English: A validated, robust, reliable and sensitive test with a prespecified positivity threshold and demonstrated utility for the determination of EGFR mutation status, using either tumor DNA derived from a tissue sample or circulating free DNA (cfDNA) obtained from a blood (plasma) sample, should be performed according to local medical practice.
Maltese: Test ivvalidat, robust, affidabbli u sensittiv li għandu livell limitu ta' pożittività speċifikat minn qabel u li huwa muri li huwa utli biex jiġi determinat l-istat ta' mutazzjoni ta' EGFR, bl-użu ta' DNA tattumur derivata minn kampjun ta' tessut jew DNA ħielsa fiċ-ċirkolazzjoni (cfDNA - circulating free DNA) miksuba minn kampjun tad-demm (plażma), għandu jitwettaq skont il-prattika medika lokali.
English: Tarceva is available in strengths of 25 mg, 100 mg and 150 mg.
Maltese: Tarceva huwa disponibbli bħala pilloli b'qawwiet ta' 25 mg, 100 mg u 150 mg.
English: PVC blister sealed with aluminium foil containing 30 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC issiġillati b'folja ta' l-aluminju li fihom 30 pillola.
English: However, when Tarceva was dosed in a staggered manner 2 hours before or 10 hours after ranitidine 150 mg b.i.d., erlotinib exposure [AUC] and maximum concentrations [Cmax] decreased only by 15% and 17%, respectively.
Maltese: Madankollu, meta Tarceva kien iddożat waħdu, sagħtejn qabel jew 10 sigħat wara ranitidine 150 mg b.i.d., l-espożizzjoni għal erlotinib [AUC] u l-konċentrazzjonijiet massimi [Cmax] naqsu biss bi 15% u 17%, rispettivament.
English: The most frequent ADRs seen in patients treated with Tarceva in study ML20650 were rash and diarrhoea (any Grade 80% and 57%, respectively), most were Grade 1/2 in severity and manageable without intervention.
Maltese: L-aktar ADRs frekwenti osservati f'pazjenti ttrattati b'Tarceva fl-istudju ML20650 kienu raxx u dijarea (kull Grad 80% u 57%, rispettivament), il-biċċa l-kbira kienu ta' Grad 1/2 fis-severità u setgħu jiġu mmaniġġjati mingħajr intervent.
English: • The other ingredients are:
Maltese: Data ta' waqfien:
English: These studies were conducted in a total of 1532 patients with advanced, recurrent or metastatic NSCLC following first-line standard platinum-based chemotherapy, no new safety signals were identified.
Maltese: Dawn l-istudji twettqu fuq total ta' 1532 pazjent b'NSCLC avanzat, rikorrenti jew metastatiku wara kimoterapija standard tal-ewwel għażla bbażata fuq platinum, ma kinux identifikati sinjali ta' sigurtà ġodda.
English: No data are available regarding the influence of severe hepatic dysfunction on the pharmacokinetics of erlotinib.
Maltese: M'hemmx dejta disponibbli dwar l-influwenza ta' funzjoni ħażina tal-fwied severa fuq il-farmakokinetika ta' erlotinib.
English: The geometric mean of the Cmax was 1056 ng/mL in the non-smokers and 689 ng/mL in the smokers with a mean ratio for smokers to non-smokers of 65.2% (95% CI: 44.3 to 95.9, p = 0.031).
Maltese: Il-medja ġeometrika ta' Cmax kienet ta' 1056 ng/mL f'dawk li ma jpejpux u 689 ng/mL f'dawk li jpejpu b' ratio medju ta' dawk li jpejpu għal dawk li ma jpejpux ta' 65.2% (95% CI: 44.3 sa' 95.9, p = 0.031).
English: The physiological relevance of the strong inhibition of CYP1A1 is unknown due to the very limited expression of CYP1A1 in human tissues.
Maltese: Ir-rilevanza fiżjoloġika ta' l-inibizzjoni b'saħħita ta' CYP1A1 mhix magħrufa minħabba d-dehra limitata ħafna ta' CYP1A1 fit-tessut uman.
English: When erlotinib was co-administered with ciprofloxacin, a moderate CYP1A2 inhibitor, the erlotinib exposure [AUC] increased significantly by 39%, while no statistically significant change in Cmax was found.
Maltese: Meta erlotinib ingħata flimkien ma' ciprofloxacin, inibitur moderat ta' CYP1A2, l-espożizzjoni għal erlotinib [AUC] żdiedet b'mod sinifikattiv b'39%, waqt li ma nstabet l-ebda bidla ta' sinifikanza statistika f'Cmax.
English: The geometric mean of the C24h was 288 ng/mL in the non-smokers and 34.8 ng/mL in the smokers with a mean ratio of 12.1% (95% CI: 4.82 to 30.2, p = 0.0001).
Maltese: Il-medja ġeometrika ta' C24h kienet ta' 288 ng/mL f'dawk li ma jpejpux u 34.8 ng/mL f'dawk li jpejpu b' ratio medju ta' 12.1% (95% CI:
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Maltese: FIS-SUQ Roche Registration GmbH.
English: CI of HR
Maltese: OS (xhur)
English: Erlotinib is characterised by a decrease in solubility at pH above 5.
Maltese: Erlotinib huwa kkaratterizzat minn tnaqqis fis-solubilità f'pH ta' aktar minn 5.
English: The proportion of patients who experienced complete response, partial response or stable disease was 44.0% and 27.5%, respectively, for the Tarceva and placebo groups (p = 0.004).
Maltese: Il-proporzjon ta' pazjenti li kellhom rispons komplut, rispons parzjali jew marda stabbli kien ta' 44.0% u 27.5%, rispettivament, għall-gruppi ta' Tarceva u plaċebo (p=0.004).
English: Based on population pharmacokinetic analysis, no clinically significant relationship between predicted apparent clearance and patient age, bodyweight, gender and ethnicity were observed.
Maltese: Ibbażat fuq analizi tal-farmakokinetika tal-popolazzjoni, ma ġiet osservata l-ebda relazzjoni klinikament sinnifikanti bejn it-tneħħija apparenti stmata u l-eta' tal-pazjent, piż, sess u etniċità.
English: Extrahepatic metabolism by CYP3A4 in intestine, CYP1A1 in lung, and CYP1B1 in tumour tissue also potentially contribute to the metabolic clearance of erlotinib.
Maltese: Metaboliżmu mhux fil-fwied, minn CYP3A4 ġol-musrana, CYP1A1 fil-pulmun, u CYP1B1 fit-tessut tat-tumur ukoll jikkontribwixxu potenzjalment għat-tneħħija metabolika ta' erlotinib.
English: Erlotinib and medicinal products altering pH
Maltese: Erlotinib u prodotti mediċinali li jbiddlu l-pH
English: Pre-treatment or co-administration of Tarceva did not alter the clearance of the prototypical CYP3A4 substrates, midazolam and erythromycin, but did appear to decrease the oral bioavailability of midazolam by up to 24%.
Maltese: Kura minn qabel jew għotja fl-istess ħin ta' Tarceva ma bidlux it-tneħħija tas-substrati prototipiċi ta' CYP3A4, midazolam u erythromycin, iżda dehru li jnaqqsu il-biodisponibiltà orali ta' midazolam b'sa 24%.
English: Contact lens use is also a risk factor for keratitis and ulceration.Very rare cases of corneal perforation or ulceration have been reported during use of Tarceva (see section 4.8).
Maltese: Kienu irrappurtati każijiet rari ħafna ta' perforazzjoni tal-korneja jew ulċerazzjoni waqt l-użu ta' Tarceva (ara sezzjoni 4.8).
English: Abnormal blood tests for the liver function
Maltese: Anormalitajiet fit-test talfunzjoni tal fwied5
English: Erlotinib increases platinum concentrations.
Maltese: Erlotinib iżid il-konċentrazzjonijiet ta' platinum.
English: Erlotinib is metabolised in the liver by the hepatic cytochromes in humans, primarily CYP3A4 and to a lesser extent by CYP1A2.
Maltese: Erlotinib huwa metabolizzat fil-fwied minn ċitokromi epatiċi fil-bnedmin, primarjament CYP3A4 u ftit anqas minn CYP1A2.
English: Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract, like proton pump inhibitors, H2 antagonists and antacids, may alter the solubility of erlotinib and hence its bioavailability.
Maltese: Prodotti mediċinali li jbiddlu l-pH tal-parti ta' fuq ta' l-apparat Gastro-Intestinali (GI) bħal inibituri tal-pompi tal-protoni, antagonisti ta' H2 u antaċidi, jistgħu jbiddlu s-solubilità ta' erlotinib u għalhekk il-biodisponibiltà tiegħu.
English: Single oral doses of Tarceva up to 1000 mg erlotinib in healthy subjects, and up to 1600 mg in cancer patients have been tolerated.
Maltese: Dożi singoli mill-ħalq ta' Tarceva sa' 1000 mg ta' erlotinib f'soġġetti f'saħħithom, u sa' 1600 mg f'pazjenti bil-kanċer kienu ttollerati.
English: Gastrointestinal disorders
Maltese: Perforazzjoni gastro-intestinali
English: Data from reproductive toxicology tests in rats and rabbits at doses near the maximum tolerated dose and/or maternally toxic doses showed reproductive (embryotoxicity in rats, embryo resorption and foetotoxicity in rabbits) and developmental (decrease in pup growth and survival in rats) toxicity, but was not teratogenic and did not impair fertility.
Maltese: Dejta minn testijiet dwar it-tossiċità riproduttiva fil-firien u fniek b'dożi li jqarrbu d-doża massima tollerata u/jew dożi li huma tossiċi għall-omm, uriet tossiċità riproduttiva (tossiċità fl-embriju tal-firien, l-embriju jiġi assorbit lura u tossiċità fil-fetu fil-fniek) u tossiċità fl-iżvilupp (tnaqqis fit-tkabbir tal-ferħ u fissopravivenza fil-firien), iżda ma kienx teratoġeniku u ma tellifx il-fertilità.
English: Secondary efficacy endpoints were all consistent with the primary endpoint and no difference was detected for OS between patients treated with erlotinib 300 mg and 150 mg daily (HR 1.03, 95% CI 0.80 to 1.32).
Maltese: Il-punti finali sekondarji tal-effikaċja kienu kollha konsistenti mal-punt finali primarju u ma ġiet osservata l-ebda differenza għal OS bejn pazjenti ttrattati b'erlotinib 300 mg u 150 mg kuljum (HR
English: Tarceva 150 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 150' engraved on one side and is available in pack sizes of 30 tablets.
Maltese: Tarceva 150 mg huwa pprovdut bħala pillola miksija b'rita, tonda, ta' kulur abjad għal safrani b'‘T 150' minquxa fuq naħa waħda u huwa disponibbli f'pakketti ta' 30 pillola.
English: • Eyelash changes
Maltese: .8 Effetti mhux mixtieqa
English: CI of Δ HR
Maltese: Δ (xhur)
English: Most were Grade 1/2 in severity and manageable without intervention.
Maltese: Ħafna kienu Grad 1/2 fis-severità u kienu kkontrollati mingħajr l-ebda intervent.
English: Alternate treatments lacking potent CYP3A4 inducing activity should be considered when possible.
Maltese: Kura alternattiva, mingħajr attività qawwija li tinduċi lil CYP3A4, trid tiġi kkunsidrata meta possibli.
English: Rare side effects (may affect up to 1 in 1,000 people): • Flushed or painful palms or soles (Palmar plantar erythrodysaesthesia syndrome)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000):
English: 90% of patients on Tarceva developed rash within the first 44 days.
Maltese: 90% tal-pazjenti fuq Tarceva żviluppaw raxx fl-ewwel 44 ġurnata.
English: Patients who never smoked had a much greater benefit from erlotinib (survival HR = 0.42, 95% CI 0.28-0.64) compared with current or ex-smokers (HR = 0.87, 95% CI 0.71-1.05).
Maltese: HR = 0.42, 95% CI 0.28-0.64) meta mqabbla ma' pazjenti li qed ipejpu jew kienu jpejpu (HR = 0.87, 95% CI 0.71-1.05).
English: In a study of 4 patients (3 with non-small cell lung cancer [NSCLC], and 1 with laryngeal cancer) receiving 150 mg daily oral doses of Tarceva, tumour samples from surgical excisions on Day 9 of treatment revealed tumour concentrations of erlotinib that averaged 1185 ng/g of tissue.
Maltese: Fi studju ta' 4 pazjenti (3 b'kanċer tal-pulmun mhux taċ-ċellula żgħira [NSCLS], u wieħed b'kanċer tal-larinġi) li ngħataw dożi kuljum ta' 150 mg ta' Tarceva mill-ħalq, kampjuni tattumur li ttieħdu minn qtugħ kirurġiku fil-Ġurnata numru 9 tal-kura wrew konċetrazzjoni fit-tumur ta' erlotinib b'medja ta' 1185 ng/g tat-tessut.
English: Erlotinib and coumarin-derived anticoagulants
Maltese: Erlotinib u sustanzi kontra t-tagħqid tad-demm derivati minn coumarin
English: Table 3: Efficacy results of Tarceva versus chemotherapy in trial ML20650 (EURTAC)
Maltese: Tabella 3: Riżultati tal-effikaċja ta' Tarceva kontra kimoterapija fil-prova ML20650 (EURTAC) Tarceva Kimoterapija Proporzjon ta' Periklu (CI ta' 95%)
English: This study was conducted in 889 patients with locally advanced or metastatic NSCLC who did not progress after 4 cycles of platinum-based doublet chemotherapy.
Maltese: Dan listudju twettaq fuq 889 pazjent b'NSCLC avanzat lokalment jew metastatiku li m'għamlux progress wara 4 ċikli ta' kimoterapija doublet ibbażata fuq platinum.
English: -Keratitis -Conjunctivitis1
Maltese: -Nefrite1
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.
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.
English: Tarceva 150 mg film-coated tablets
Maltese: Tarceva 150 mg pilloli miksija b'rita
English: The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years.
Maltese: Is-sigurtà u l-effikaċja ta' erlotinib fl-indikazzjonijiet approvati ma ġewx determinati f'pazjenti taħt letà ta' 18-il sena.
English: In a meta-analysis of NSCLC randomised controlled clinical trials (excluding phase I and single-arm phase II studies due to lack of control groups), the incidence of ILD-like events was 0.9% on Tarceva compared to 0.4% in patients in the control arms.
Maltese: II minħabba nuqqas ta' gruppi ta' kontroll), l-inċidenza ta' każijiet jixbhu lil ILD kienet ta' 0.9% fuq Tarceva meta mqabbel ma' 0.4% f'pazjenti fil-gruppi ta' kontroll.
English: This effect was accompanied by a 24% increase in apparent erlotinib plasma clearance.
Maltese: Dan l-effett kien akkumpanjat minn żjieda ta' 24% fittneħħija apparenti ta' erlotinib mill-plażma.
English: Results of a pharmacokinetic interaction study indicated a significant 2.8-, 1.5- and 9-fold reduced AUCinf, Cmax and plasma concentration at 24 hours, respectively, after administration of Tarceva in smokers as compared to non-smokers.
Maltese: Ir-riżultati ta' studju ta' interazzjoni farmakokinetika indikaw tnaqqis sinnifikanti ta' 2.8-, 1.5-, u 9drabi l-AUCinf, Cmax u l-konċentrazzjoni tal-plażma wara 24 siegħa, rispettivament, wara l-għotja ta' Tarceva f'pazjenti li jpejpu meta mqabbla ma' dawk li ma jpejpux.
English: NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Erlotinib
Maltese: Tarceva 25 mg pilloli miksija b'rita Erlotinib
English: Extrahepatic metabolism by CYP3A4 in intestine, CYP1A1 in lung, and 1B1 in tumour tissue potentially contribute to the metabolic clearance of erlotinib.
Maltese: Metaboliżmu mhux mill-fwied, minn CYP3A4 fil-musrana, CYP1A1 filpulmun, u 1B1 fit-tessut tat-tumur potenzjalment jikkontribwixxu għat-tneħħija metabolika ta'
English: Results are shown in the table below (results for the group of metastatic and locally advanced patients are derived from exploratory subgroup analysis).
Maltese: Ir-riżultati huma murija fit-tabella taħt (riżultati għall-grupp ta' pazjenti b'kanċer metastatiku jew avanzat lokalment huma derivati minn analiżi esploratorja ta' sottogrupp).
English: Excipients with known effect
Maltese: Ma ġewx identifikati effetti ta' kovarjanti ġodda.
English: Stomatitis
Maltese: Analiżi
English: Eye irritation due to conjunctivitis/keratoconjunctivitis (very common: may affect more than 1 out of 10 people) and keratitis (common: may affect up to 1 in 10 people).
Maltese: • Irritazzjoni fl-għajnejn ikkawżata minn konġuntivite/keratokonġuntivite (komuni ħafna: jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) u keratite (komuni: jistgħu jaffettwaw sa persuna waħda minn kull 10).
English: Tarceva has not been studied in patients under the age of 18 years.
Maltese: Ma sarux studji dwar Tarceva f'pazjenti b'età inqas minn 18-il sena.
English: Dose modifications (interruptions or reductions) for rash and diarrhoea were needed in 11% and 7% of patients, respectively.
Maltese: Modifiki fid-doża (interruzzjonijiet jew tnaqqis) għal raxx u dijarea kienu meħtieġa fi 11% u 7% tal-pazjenti, rispettivament.
English: Potent inhibitors of CYP3A4 activity decrease erlotinib metabolism and increase erlotinib plasma concentrations.
Maltese: Inibituri qawwija ta' l-attività ta' CYP3A4 inaqqsu l-metaboliżmu ta' erlotinib u jżidu ilkonċentrazzjoni ta' erlotinib fil-plażma.
English: Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 25' engraved on one side and is available in pack sizes of 30 tablets.
Maltese: Tarceva 25 mg huwa pprovdut bħala pillola miksija b'rita, tonda, ta' kulur abjad għal safrani b'‘T 25' minquxa fuq naħa waħda u huwa disponibbli f'pakketti ta' 30 pillola.
English: NAME OF THE MEDICINAL PRODUCT Tarceva 150 mg film-coated tablets Erlotinib
Maltese: Tarceva 150 mg pilloli miksija b'rita Erlotinib
English: Dose reductions by 25 mg steps have not been investigated.
Maltese: Tnaqqis tad-doża bi kwantitajiet ta' 25 mg ma ġewx investigati.
English: The clinical relevance of these differences is unclear.
Maltese: Ir-rilevanza klinika ta' dawn id-differenzi mhux ċara.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2. tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Based on pharmacokinetic data no dose adjustments appear necessary in patients with mild or moderate renal impairment (see section 5.2).
Maltese: Ibbażat fuq dejta farmakokinetika, ma jidhirx li hemm bżonn ta' aġġustament fid-doża f'pazjenti b'indeboliment ħafif jew moderat renali (ara sezzjoni 5.2).
English: Any Grade
Maltese: U KWANTITATTIVA
English: Gastrointestinal perforations have been observed (uncommon: may affect up to 1 in 100 people).
Maltese: • Kienu osservati perforazzjonijiet gastro-intestinali (mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100).
English: APPROPRIATE
Maltese: LISTA
English: There were no significant effects of erlotinib on the pharmacokinetics of capecitabine.
Maltese: Ma kien hemm l-ebda effetti sinifikanti ta' erlotinib fuq il-farmakokinetika ta' capecitabine.
English: Study endpoints included overall survival, progression-free survival (PFS), response rate, duration of response, time to deterioration of lung cancer-related symptoms (cough, dyspnoea and pain), and safety.
Maltese: Il-punti finali tal-istudju inkludew sopravivenza totali, sopravivenza mingħajr progressjoni (PFS), rata ta' rispons, tul tar-rispons, żmien sakemm is-sintomi relatati mal-kanċer tal-pulmun (sogħla, qtugħ ta' nifs u uġigħ) jiddeterjoraw, u sigurtà.
English: Tarceva 100 mg film-coated tablets
Maltese: Tarceva 100 mg pilloli miksija b'rita
English: NAME OF THE MEDICINAL PRODUCT Tarceva 100 mg film-coated tablets Erlotinib
Maltese: Tarceva 100 mg pilloli miksija b'rita Erlotinib
English: Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see section 4.5).
Maltese: L-użu flimkien ma' substrati u modulaturi ta' CYP3A4 jista' jinħtieġ aġġustament fid-doża (ara sezzjoni 4.5).
English: Erlotinib is eliminated by hepatic metabolism and biliary excretion.
Maltese: Erlotinib jiġi eliminat permezz ta' metaboliżmu fil-fwied u eskrezzjoni biljari.
English: Significant interactions with the clearance of other CYP3A4 substrates are therefore unlikely.
Maltese: Għalhekk, interazzjonijiet sinifikanti mat-tneħħija ta' substrati oħra ta' CYP3A4 huma improbabbli.
English: A second population pharmacokinetic analysis was conducted that incorporated erlotinib data from 204 pancreatic cancer patients who received erlotinib plus gemcitabine.
Maltese: Sar analiżi tal-farmakokinetika tal-popolazzjoni ieħor li nkorpora dejta ta' erlotinib minn 204 pazjenti b'kanċer tal-frixa li rċevew erlotinib flimkien ma' gemcitabine.
English: -Liver function test abnormalities
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Hazard Ratio (95% CI)
Maltese: 82 (95% CI: 0.69, 0.98),
English: Tarceva 25 mg film coated tablets
Maltese: Tarceva 25 mg pilloli miksija b'rita
English: Each film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 25 mg erlotinib (bħala erlotinib hydrochloride).
English: EGFR mutations may lead to constitutive activation of anti-apoptotic and proliferation signaling pathways.
Maltese: Mutazzjonijiet ta' EGFR jistgħu jwasslu għall-attivazzjoni kostituttiva tar-rotot ta' sinjalazzjoni anti apoptotiċi u ta' proliferazzjoni.
English: Pregnancy
Maltese: Esploratorja
English: Although statistically significant, the magnitude of this difference is not considered to be clinically relevant.
Maltese: Għalkemm statistikament sinifikanti, il-kobor ta' din id-differenza mhux ikkunsidrat li huwa klinikament rilevanti.
English: Each film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 150 mg ta' erlotinib (bħala erlotinib hydrochloride).
English: Interstitial Lung Disease
Maltese: Disturbi psikjatriċi
English: Pancreatic cancer (Tarceva administered concurrently with gemcitabine)
Maltese: Kanċer tal-frixa (Tarceva mogħti flimkien ma' gemcitabine)
English: • Brittle and loose nails
Maltese: • Diffikultà biex tieħu nifs, sogħla
English: Tarceva is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR).
Maltese: Tarceva huwa mediċina li tintuża fil-kura tal-kanċer billi tipprevjeni l-attività ta' proteina msejħa riċettur tal-fattur tal-iżvilupp epidermali (EGFR).
English: Baseline demographic and disease characteristics of the patients were similar between the 2 treatment groups, 100 mg Tarceva plus gemcitabine or placebo plus gemcitabine, except for a slightly larger proportion of females in the erlotinib/gemcitabine arm compared with the placebo/gemcitabine arm:
Maltese: Il-linja bażi tal-karatteristiċi demografiċi u tal-marda tal-pazjenti kienu simili bejn iż-żewġ gruppi ta' kura, 100 mg ta' Tarceva flimkien ma' gemcitabine jew plaċebo flimkien ma' gemcitabine, għajr għal proporzjon kemmxejn akbar ta' nisa fil-grupp ta' erlotinib/gemcitabine meta mqabbel mal-grupp ta' plaċebo/gemcitabine:
English: (months)
Maltese: (xhur)
English: Co-administration of erlotinib with omeprazole, a proton pump inhibitor (PPI), decreased the erlotinib exposure [AUC] and maximum concentration [Cmax] by 46% and 61%, respectively.
Maltese: L-għotja flimkien ta' erlotinib ma' omeprazole, inibitur tal-pompi tal-protoni (PPI), naqqsu l-espożizzjoni għal erlotinib [AUC] u l-konċentrazzjoni massima [Cmax] b'
English: Studies in animals have shown no evidence of impaired fertility.
Maltese: Studji fuq l-annimali ma wrew l-ebda evidenza ta' tnaqqis fil-fertilità.
English: Other medicines and Tarceva
Maltese: Mediċini oħra u Tarceva
English: Hepato biliary disorders
Maltese: Popolazzjoni b'marda Metastatika
English: The efficacy and safety of Tarceva as second/third-line therapy was demonstrated in a randomised, double-blind, placebo-controlled trial (BR.21), in 731 patients with locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen.
Maltese: L-effikaċja u s-sigurtà ta' Tarceva bħala terapija tat-tieni/ tielet preferenza intweriet fi prova randomised, double-blind u kkontrollata bil-plaċebo (BR.21), f'731 pazjent b'NSCLC lokalment avanzat jew li mmetastatizza wara falliment ta' minn ta' l-inqas kors wieħed ta' kimoterapija.
English: Use of Tarceva in patients with severe hepatic dysfunction is not recommended (see section 5.2).
Maltese: Lużu ta' Tarceva f'pazjenti b'disfunzjoni severa tal-fwied mhux irrakkomandat (ara sezzjoni 5.2).
English: Warnings and precautions:
Maltese: Twissijiet u prekawzjonijiet:
English: In a phase I dose escalation study in NSCLC patients who were current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg. Steady-state trough plasma concentrations at a 300 mg dose in current smokers in this study was 1.22 µg/mL (n=17).
Maltese: Id-doża ta' 300 mg ma wrietx titjib fl-effikaċja fit-trattament tat-tieni għażla wara li falliet il-kimoterapija meta mqabbla mad doża rrakkomandata ta' 150 mg f'pazjenti li jkomplu jpejpu s-sigaretti.