FrancophonIA/ELRC3.0 huggingface dataset:
English: The warning signs of a hypo may come on suddenly and can include: cold sweat, cool pale skin, headache, rapid heart beat, feeling sick, feeling very hungry, temporary changes in vision, drowsiness, unusual tiredness and weakness, nervousness or tremor, feeling anxious, feeling confused, difficulty in concentrating.
Maltese: Is-sinjali ta' twissija ta' ipogliċemija jistgħu jkunu f'daqqa u jistgħu jinkludu: togħriq kiesaħ, ġilda kiesħa u pallida, uġigħ ta' ras; qalb tħabbat malajr; tħossok marid; tħossok bil-ġuħ ħafna; bidla filvista temporanja; ngħas; għeja mhux tas-soltu u debulizza; nervożità jew rogħda; tħossok konfuż; diffikultà biex tikkonċentra.
English: Hypoglycaemic coma and hypoglycaemic unconsciousness
Maltese: X'inhu Enyglid u għalxiex jintuża
English: 90 tablets: EU/1/09/580/015
Maltese: EU/1/09/580/015
English: Combination with metformin
Maltese: .8 Effetti mhux mixtieqa
English: Repaglinide should be avoided during pregnancy.
Maltese: Repaglinide għandu jiġi evitat waqt it-tqala.
English: The 2 mg tablets are pink, marbled, round, biconvex with bevelled edges and possible darker spots.
Maltese: Il-pilloli ta' 2 mg huma roża, mraħħma, tondi, mżaqqa fuq żewġ naħat bi truf iċċanfrati u possibilment bi dbabar aktar suwed.
English: 60 tablets: EU/1/09/580/002
Maltese: EU/1/09/580/002
English: Repaglinide metabolites are excreted primarily via the bile.
Maltese: Il-metaboli ta' repaglinide jiġu mneħħija primarjament permezz tal-bile.
English: The effect of ketoconazole, a prototype of potent and competitive inhibitors of CYP3A4, on the pharmacokinetics of repaglinide has been studied in healthy subjects.
Maltese: L-effett ta' ketoconazole, l-eżempju klassiku ta' inibituri qawwijin u kompetittivi ta' CYP3A4, fuq ilfarmakokinetika ta' repaglinide, kien studjat f'pazjenti b'saħħithom.
English: 120 tablets: EU/1/09/580/016 180 tablets: EU/1/09/580/021 270 tablets: EU/1/09/580/017 360 tablets: EU/1/09/580/018
Maltese: EU/1/09/580/017 360 pillola:
English: 90 tablets: EU/1/09/580/009
Maltese: EU/1/09/580/009
English: 360 tablets: EU/1/09/580/006
Maltese: EU/1/09/580/006
English: 30 tablets: EU/1/09/580/001
Maltese: EU/1/09/580/001
English: Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
Maltese: L-użu ta' repaglinide f'każ ta' falliment sekondarju għal sustanzi li jikkawżaw it-tnixxija tal-insulina ma ġiex investigat fi studji kliniċi.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Maltese: Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni u riskju ta' kanċer, ma turi l-ebda periklu speċjali għall-bnedmin.
English: The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction), see sections 4.8 and 5.1.
Maltese: L-użu ta' repaglinide jista' jkun assoċjat ma' żieda fl-inċidenza tas-sindromu koronarju akut (eż. infart mijokardjali), ara sezzjonijiet 4.8 u 5
English: 90 tablets: EU/1/09/580/003
Maltese: EU/1/09/580/003
English: This phenomenon is known as secondary failure, to distinguish it from primary failure, where the medicinal product is ineffective in an individual patient when first given.
Maltese: Dan il-fenomenu huwa magħruf bħala falliment sekondarju biex jiġi distint minn falliment primarju, fejn il-prodott mediċinali ma jkunx effettiv f'pazjent individwali millewwel darba li tingħata.
English: 120 tablets: EU/1/09/580/004 180 tablets: EU/1/09/580/019 270 tablets: EU/1/09/580/005 360 tablets: EU/1/09/580/006
Maltese: EU/1/09/580/019 270 pillola:
English: It has not been studied in these age groups.
Maltese: Gruppi speċjali ta' pazjenti
English: 120 tablets: EU/1/09/580/010 180 tablets: EU/1/09/580/020 270 tablets: EU/1/09/580/011 360 tablets: EU/1/09/580/012
Maltese: EU/1/09/580/020 270 pillola:
English: Less than 1% of repaglinide is recovered in faeces.
Maltese: Inqas minn 1% ta' repaglinide joħroġ fl-ippurgar.
English: 60 tablets: EU/1/09/580/008
Maltese: EU/1/09/580/008
English: 180 tablets: EU/1/09/580/019
Maltese: EU/1/09/580/018
English: Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β-cells in the pancreatic islets.
Maltese: Repaglinide inaqqas b'mod akut il-livelli tal-glucose fid-demm billi jistimula l-ħruġ ta' l-insulina mill-frixa, effett li jiddependi fuq il-funzjoni taċ-ċelloli  fl-islets pankreatiċi.
English: Abdominal pain, diarrhoea Common Vomiting, constipation
Maltese: Uġigħ addominali, dijarea Komuni Rimettar, stitikezza
English: KRKA-POLSKA Sp.z o.o.
Maltese: GĦALL-ĦRUĠ TALLOTT
English: Busuttil Ltd. Tel: + 356 21 445 855
Maltese: Tel: + 356 21 445 855
English: Combination with insulin secretagogues
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: 1 Artikolu 29(4) tad-Direttiva 2001/83/KE, kif emendat.
English: The Rapporteur was Dr. Frits Lekkerkerker and Co-Rapporteur was Dr. Ian Hudson.
Maltese: Ir-Rapporteur kien Dr. Frits Lekkerkerker u l-Ko-Rapporteur kien Dr. Ian Hudson.
English: London, 18 September 2007 EMEA/283378/2007
Maltese: Londra, 18 ta' Settembru 2007 EMEA/448450/2007
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: International Non-Proprietary Name (INN): lansoprazole
Maltese: Mhux Patentat (INN): lansoprazole
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
Maltese: OPINJONI WARA REFERENZA SKOND L'ARTIKOLU 29(4)1 GĦALL
English: The Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, the Netherlands, Norway, Poland, Portugal, the Slovak Republic, Spain and Sweden.
Maltese: L-Istat Membru ta' referenza kien ir-Renju Unit u l-Istati Membri Konċernati kienu l-Awstrija, il-Belġju, irRepubblika Ċeka, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, l-Ungerija, l-Irlanda, l-Olanda, inNorveġja, il-Polonja, il-Portugall, ir-Repubblika tas-Slovakkja, Spanja, u l-Iżvezja.
English: The Marketing Authorisation Holder provided written explanations on 30 March 2007.
Maltese: Id-detentur ta' l-Awtorizzazzjoni GħatTqegħid fis-Suq ipprovda spjegazzjonijiet bil-miktub fit-30 ta' Marzu 2007.
English: The Czech Republic, Spain and Portugal referred the reasons for disagreement to the EMEA on 30 November 2006.
Maltese: Ir-Repubblika Ċeka, Spanja u l-Portugall, irreferew ir-raġunijiet għan-nuqqas ta' qbil lill-EMEA fit-30 ta' Novembru 2006.
English: Lansoprazole 15 & 30 mg gastro-resistant capsules, hard are generic preparations containing lansoprazole as the active substance.
Maltese: Kapsuli gastro-reżistenti iebsin Lansoprazole tal-15 u 30 mg, huma preparazzjonijiet ġeneriċi li fihom lansoprazole bħala s-sustanza attiva.
English: TEVA UK Limited submitted applications for mutual recognition of Lansoprazole and associated names, 15 and 30 mg, gastro-resistant capsules, hard, on the basis of the marketing authorisation granted by the United Kingdom on 9 December 2005.
Maltese: TEVA UK Limited ippreżentat applikazzjonijiet għar-rikonoxximent reċiproku tal-kapsuli gastro-reżistenti Lansoprazole tal-15 u 30 mg u ismijiet assoċjati, skond l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mirRenju Unit fid-9 ta' Diċembru 2005.
English: Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion and is used for the treatment of duodenal and benign gastric ulcers, gastro-oesophageal reflux disease and associated conditions.
Maltese: Lansoprazole huwa inibitur proton pump li jinibixxi t-tnixxija ta' laċidu gastriku li jintuża fit-trattament ta' ulċeri duwodenali u beninni fl-istonku, marda reflux gastroesofagali u kundizzjonijiet assoċjati.
English: During their 18 - 21 June 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazole and associated names, that the objections raised by the Czech Republic, Spain and Portugal should not prevent the granting of a Marketing Authorisation and that the valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Waqt il-laqgħa tagħhom ta' bejn it-18 u l-21 ta' Ġunju 2007, il-CHMP, fid-dawl tat-tagħrif ġenerali mogħti u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien ta' l-opinjoni li, l-proporzjon ta' riskju/benefiċċju kien favorevoli għal Lansoprazole u ismijiet assoċjati, li l-oġġezzjonijiet imressqa mir-Repubblika Ċeka, Spanja u l-Portugall m'għandhomx iċaħħdu l-għoti ta' Awtorizzazzjoni għal Tqegħid fis-Suq u li s-Sommarju talKaratteristiċi tal-Prodott validu, it-tikketta u l-fuljett ta' tagħrif huma l-verżjonijiet finali miksuba waqt ilproċedura ta' koordinazzjoni tal-Grupp.
English: European Medicines Agency Evaluation of Medicines for Human Use
Maltese: KUMITAT GĦALL-PRODOTTI MEDIĊINALI
English: The arbitration procedure started on 14 December 2006 with the adoption of a list of questions.
Maltese: Il-proċedura arbitrarja bdiet fl-14 ta' Diċembru 2006 bl-adozzjoni ta' lista ta' mistoqsijiet.
English: Lansoprazole and associated names
Maltese: Isem Internazzjonali
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP)
English: A positive opinion was adopted by consensus on 21 June 2007.
Maltese: Ġiet adottata opinjoni pożittiva b'kunsens fil-21 ta' Ġunju 2007.
English: 24 April 2017
Maltese: 24 ta' April 2017
English: Female fertility was not investigated.
Maltese: Il-fertilità femminili ma ġietx investigata.
English: Abbreviation: CI = confidence interval.
Maltese: CI = confidence interval;
English: • Median (m)
Maltese: • Medjan (m)
English: Hospira UK Limited
Maltese: Hospira UK Limited Horizon
English: ATC code: L01BA04.
Maltese: L01BA04.
English: UNIQUE IDENTIFIER- 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: *Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Maltese: Komuni ħafna- ≥ 10%; Komuni - > 5% and < 10%.
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Maltese: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event - Kriterji ta' Terminoloġija Komuni għal Każijiet Avversi; NCI = National Cancer Institute - Istitut Nazzjonali tal-Kanċer; SGOT = serum glutamic oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
English: Adenocarcinom a (N = 847)
Maltese: Adenokarcinom a (N = 847)
English: ITT population (N = 1725)
Maltese: Popolazzjoni ITT (N = 1725)
English: Honey Lane
Maltese: Honey Lane Hurley
English: Contains mannitol
Maltese: Fih mannitol
English: Placebo*** (N = 402)
Maltese: Plaċebo*** (N = 402)
English: Loss of sensation
Maltese: Telf ta' sensazzjoni
English: Stomatitis/ Pharyngitis 14.7 1.1 Nausea
Maltese: Stomatite/Farinġite 14.7 1.1 Dardir
English: The pH of the reconstituted solution is between 5.7 and 7.7.
Maltese: Il-pH tas-soluzzjoni rikostitwita hi bejn 5.7 u 7.7.
English: Tel: +420-283-004-111
Maltese: s r.o. Tel: +420-283-004-111
English: Store below 30°C
Maltese: Aħżen f'temperatura taħt 30
English: Rash Alopecia
Maltese: Raxx Alopeċja
English: ITT population and histology subgroups
Maltese: ITT u sottogruppi istoloġiċi
English: • 95% CI for HR
Maltese: • 95% CI għal HR
English: • Median
Maltese: • Medjan
English: There are many sorts of NSAIDs with different durations of activity.
Maltese: Hemm ħafna tipi ta' NSAIDs b'tul ta' żmien ta' attività differenti.
English: Alkaline phosphatase (ALP), aspartate aminotransferase (AST or SGOT), and alanine aminotransferase (ALT or SGPT) should be ≤ 3-times upper limit of normal.
Maltese: Alkaline phosphatase (ALP), aspartate aminotransferase (AST jew SGOT) u alanine aminotransferase (ALT jew SGPT) għandhom ikunu ≤ 3-darbiet il-massimu tan-normal.
English: Frequency Event*
Maltese: Frekwenza*
English: 2D barcode carrying the unique identifier included
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Myelosuppression is usually the dose-limiting toxicity.
Maltese: Il-majelosoppressjoni normalment hija it-tossiċità li tillimita d-doża.
English: Common Rash/desquamation 8.1
Maltese: Raxx/deskwamazzjoni 8.1 0.1 3.7
English: • Response rate (%) (95% CI)
Maltese: • Rata ta' rispons (%) (95% CI)
English: The active substance is pemetrexed.
Maltese: Is-sustanza attiva hija pemetrexed.
English: The percentage of patients that received post-study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Maltese: Il-persentaġġ ta' pazjenti li rċevew kura wara listudju kien ta' 64.3% għal pemetrexed u 71.7% għal plaċebo.
English: Pfizer Pharma PFE GmbH Tel: + 49 (0) 800 8535555
Maltese: PFE GmbH Tel: + 49 (0) 800 8535555
English: • Stable disease (%)
Maltese: • Marda stabbli (%)
English: Malignant pleural mesothelioma
Maltese: Mesoteljoma plewrali malinna
English: Stomatitis/Pharyngitis 23.2 3.0 Nausea
Maltese: Stomatite/Farinġite 23.2 Dardir
English: Dose of pemetrexed (mg/m2)
Maltese: Doża ta' pemetrexed (mg/m
English: Efficacy of pemetrexed vs. docetaxel in NSCLC - ITT population pemetrexed docetaxel
Maltese: Effikaċja ta' pemetrexed vs docataxel f'popolazzjoni ta' NSCLC - ITT Pemetrexed
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues.
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi.
English: Anaphylactic shock (severe allergic reaction)
Maltese: Xokk anafilattiku (reazzjoni allerġika severa)
English: N = 863 0.94a
Maltese: N = 863 0.94
English: CTC a Grade
Maltese: Grad CTC
English: Common ALT (SGPT) elevation
Maltese: Żieda fl-SGPT (ALT)
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Maltese: Komuni ħafna ( > 1/10 ), komuni ( > 1/100 sa < 1/10), mhux komuni ( > 1/1000 sa < 1/100), rari ( > 1/10,000 sa < 1/1000), rari ħafna (≤ 1/10,000) u mhijiex magħrufa (ma tistax tiġi stmata mir-rapporti ta' informazzjoni spontanja li hemm disponibbli).
English: The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day (see section 4.4).
Maltese: Il-kortikosterojdi għandu jkun ekwivalenti għal 4 mg ta' dexamethasone meħud b'mod orali darbtejn kuljum (ara sezzjoni 4.4).
English: Dose for cisplatin (mg/m2)
Maltese: Doża għal Cisplatin (mg/m
English: 75% of previous dose (both pemetrexed and cisplatin)
Maltese: 75% tad-doża ta' qabel (kemm pemetrexed u cisplatin)
English: In vitro studies indicate that pemetrexed is approximately 81% bound to plasma proteins.
Maltese: Studji in vitro jindikaw li madwar 81% ta' pemetrexed jintrabat mal-proteini tal-plażma.
English: Adjusted hazard ratio (HR) (95% CI)
Maltese: Proporzjon ta' riskju aġġustat (HR) (95% CI)
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Maltese: Ġew evalwati wkoll l-analiżi ta' sensittività ta' punti aħħarin ta' effikaċja primarja fil-popolazzjoni Kwalifikata b'Protokoll (Protocol Qualified, PQ).
English: Patients also required lower administration of erythropoietin/darbopoietin (10.4% versus 18.1%, p < 0.001), G-CSF/GM-CSF (3.1% versus 6.1%, p = 0.004), and iron preparations (4.3% versus 7.0%, p = 0.021).
Maltese: Il-pazjenti kellhom bżonn ukoll ta' anqas għotjiet ta' eritropoijetin/darbopoietin (10.4% kontra 18.1%, p<0.001), G-CSF/GM-CSF (3.1% kontra 6.1%, p = 0.004), u preparazzjonijiet ta' ħadid (4.3% kontra 7.0%, p = 0.021).
English: Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia, and anaemia (or pancytopenia) (see section 4.8).
Maltese: Pemetrexed jista' jissopprimi l-funzjoni tal-mudullun kif manifestat min-newtropenja, tromboċitopenja u anemija (jew panċitopenja) (ara sezzjoni 4.8).
English: Pemetrexed total systemic clearance is 91.8 ml/min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 ml/min).
Maltese: It-tneħħija sistemika totali ta' pemetrexed hija ta' 91.8 ml/min u l-half-life tal-eliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni tal-kliewi normali (tneħħija tal-kreatinina ta' 90 ml/min).
English: Mesothelioma
Maltese: Mesoteljoma
English: NSCLC, first-line treatment
Maltese: NSCLC, It-trattament tal-ewwel preferenza
English: A significant increase in the incidence of possibly study-medicinal product-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤6 cycles: 3.3%, >6 cycles: 6.4%: p=0.046).
Maltese: Ġiet osservata, wisq probabbli kkawżata mill-prodott mediċinali taħt studju, żieda fl-inċidenza ta' newtropenja ta' Grad 3/4 b'espożizzjoni itwal għal pemetrexed (≤6 ċikli: 3.3%, > 6 ċikli: 6.4%: p=0.046).
English: 75% of previous dose
Maltese: 75% tad-doża ta' qabel
English: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Maltese: Id-data tal-PFS ġew parzjalment ikkonfermati minn stħarriġ indipendenti (400/1725 pazjent ġew magħżula b'mod każwali għall-istħarriġ).
English: The total bilirubin should be ≤ 1.5-times upper limit of normal.
Maltese: It-total ta' bilirubina għandu jkun ta' ≤ 1.5 darbiet il-limitu massimu tan-normal.
English: A total of 213 patients (48.3%) completed ≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with pemetrexed.
Maltese: Kien hemm total ta' 213-il pazjent (48.3 %) li temmew ≥ 6 ċikli u total ta' 103 pazjenti (23.4 %) li temmew ≥ 10 ċikli ta' kura bi pemetrexed.
English: Breast-feeding (see section 4.6).
Maltese: Treddigħ (ara sezzjoni 4.6)
English: Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
Maltese: B12 u folic acid jingħatawlek sabiex jitnaqqsu l-effetti tossiċi possibbli tal-kura kontra l-kanċer.
English: Between-patient variability in clearance is moderate at 19.3%.
Maltese: Il-varjabilità fit-tneħħija bejn il-pazjenti hija moderata f'perċentwali ta' 19.3 %.
English: NSCLC, maintenance treatment JMEN
Maltese: NSCLC, trattament ta' manteniment
English: Other undesirable effects include renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis and neuropathy.
Maltese: Effetti mhux mixtieqa oħra jinkludu tossiċitajiet renali, żieda f'aminotransferases, alopeċja, għeja, diżidratazzjoni, raxx, infezzjoni/sepsis u newropatija.
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1,000 micrograms) that you must take once a day while you are taking Pemetrexed Pfizer.
Maltese: Supplimentazzjoni b'vitamini: it-tabib tiegħek ser jordnalek folic acid (vitamina) orali jew xi prodott multivitaminiku li fih folic acid (350 sa 1000 mikrogramma) li trid tieħu darba kuljum waqt it-trattament b'Pemetrexed Pfizer.
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of medicinal products metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Maltese: Riżultati ta' studji in vitro b'mikrożomi tal-fwied umani juru li mhux previst li pemetrexed jikkawża l-inibizzjoni klinikament sinifikanti tat-tneħħija metabolika ta' prodotti mediċinali li jkunu metabolizzati b'CYP3A, CYP2D6, CYP2C9, u CYP1A2.
English: Leucocytes decreased 17.8 Platelets decreased
Maltese: Tnaqqis fil-lewkoċiti 17.8
English: In vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter).
Maltese: Studji in vitro juru li b'mod attiv OAT3 (organic anion transporter) inixxi lil pemetrexed.
English: In vitro studies have shown that pemetrexed behaves as a multi-targeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Maltese: Studji in vitro wrew li pemetrexed jaġixxi bħala antifolat b'iżjed minn objettiv wieħed billi jinibbixxi thymidylate synthase (TS), dihydrofolate reductase (DHFR), u glycinamide ribonucleotide formyltransferase (GARFT), li huma enzimi dipendenti fuq il-folate u huma kruċjali għall-bijosintesi de novo tan-nukleotidi thymidine u purine.
English: Efficacy parameter pemetrexed / cisplatin (N = 226)
Maltese: Parametru ta' effikaċja Pemetrexed / Cisplatin (N = 226)
English: Method of administration For Precautions to be taken before handling or administering Pemetrexed Pfizer, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwazzjoni ta' Pemetrexed Pfizer qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Pemetrexed total systemic exposure (AUC) and maximum plasma concentration increase proportionally with dose.
Maltese: L-espożizzjoni sistemika totali (AUC) u l-ogħla konċentrazzjoni fil-plażma ta' pemetrexed jiżdiedu proporzjonalment mad-doża.
English: Alkaline phosphatase, AST, and ALT ≤ 5-times upper limit of normal is acceptable if liver has tumour involvement.
Maltese: Alkaline phosphatase, AST u ALT ≤ 5 darbiet il-limitu massimu tan-normal hu aċċettabbli jekk il-fwied għandu involviment ta' tumur.
English: Pre-medication regimen
Maltese: TAL-PRODOTT MEDIĊINALI
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 wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Reconstituted and infusion solutions: When prepared as directed, chemical and physical in-use stability has been demonstrated for 24 hours at refrigerated temperature (2°C to 8°C) and at 25°C.
Maltese: Meta ppreparati kif suppost, l-istabbilità kimika u fiżika ta' waqt l-użu ġiet ippruvata għal 24 siegħa f'temperatura ta' friġġ (2°C sa 8°C) u f'25°C.
English: AST (SGOT) elevation
Maltese: Żieda fl-SGOT (AST)
English: Kaplan-Meier plots of overall survival by histology
Maltese: Dijagrammi Kaplan Meier tas-sopravivenza totali skont l-istoloġija
English: A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the pemetrexed /cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Maltese: Titjib statistikament sinifikanti fis-sintomi klinikament rilevanti (uġigħ u qtugħ ta' nifs) assoċjati ma' mesoteljoma plewrali malinna kien dimonstrat fil-fergħa ta' pemetrexed/cisplatin (212-il pazjent) meta kkomparat mal-fergħa ta' cisplatin waħdu (218-il pazjent) permezz tal-Lung Cancer Symptom Scale.
English: Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4% versus 28.9%, p < 0.001), red blood cell transfusions (16.1% versus 27.3%, p < 0.001) and platelet transfusions (1.8% versus 4.5%, p =0.002).
Maltese: Pazjenti kkurati bi pemetrexed u cisplatin kellhom bżonn ta' anqas trasfużjonijiet (16.4% kontra 28.9%, p<0.001), trasfużjonijiet ta' ċelluli ħomor tad-demm (16.1% kontra 27.3%, p<0.001) u trasfużjonijiet ta' plejtlits (1.8% kontra 4.5%, p = 0.002).