FrancophonIA/ELRC3.0 huggingface dataset:
English: This document is a summary of the European public assessment report (EPAR) for Leflunomide medac.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Leflunomide medac.
English: Other information about Leflunomide medac:
Maltese: Informazzjoni oħra dwar Leflunomide medac:
English: Leflunomide medac leflunomide
Maltese: Kif jintuża Leflunomide medac?
English: Leflunomide medac is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Maltese: Leflunomide medac jintuża biex jikkura adulti b'artrite rewmatojde attiva (marda tas-sistema immuni li tikkawża infjammazzjoni tal-ġogi) jew artrite psorjatika attiva (marda li tikkawża rqajja' ħomor bilqoxra fuq il-ġilda u infjammazzjoni tal-ġogi).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide medac on 27 July 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Leflunomide medac valida flUnjoni Ewropea kollha fis-27 ta' Lulju 2010.
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide medac has been shown to have comparable quality and to be bioequivalent to Arava.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Leflunomide medac wera li għandu kwalità komparabbli ma' u huwa bijoekwivalenti għal Arava.
English: Leflunomide medac is a medicine that contains the active substance leflunomide.
Maltese: Leflunomide medac huwa mediċina li fiha s-sustanza attiva leflunomide.
English: Leflunomide medac treatment usually starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Maltese: Il-kura b'Leflunomide medac ġeneralment tibda b'‘doża ta' tagħbija' ta' 100 mg darba kuljum għal tlett ijiem, segwita minn doża ta' manteniment.
English: Because Leflunomide medac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Maltese: Minħabba li Leflunomide medac huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċju u r-riskju tagħha huma meqjusa li huma analogi għal dawk tal-mediċini ta' referenza.
English: Because Leflunomide medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Maltese: Billi Leflunomide medac huwa mediċina ġenerika, l-istudji ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċini ta' referenza, Arava.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku leflunomide
English: How has Leflunomide medac been studied?
Maltese: Kif ġie studjat Leflunomide medac?
English: What is Leflunomide medac?
Maltese: Għalxiex jintuża Leflunomide medac?
English: What are the benefit and risk of Leflunomide medac?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Leflunomide medac?
English: This means that Leflunomide medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Maltese: Dan ifisser li Leflunomide medac jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Arava.
English: A risk management plan has been developed to ensure that Leflunomide medac is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Leflunomide medac jintuża bl-aktar mod sigur possibbli.
English: Why has Leflunomide medac been approved?
Maltese: Għaliex ġie approvat Leflunomide medac?
English: Leflunomide medac treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Maltese: Il-kura b'Leflunomide medac għandha tinbeda u tiġi sorveljata minn speċjalista li għandu esperjenza fil-kura tal-artrite rewmatojde u l-artrite psorjatika.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide medac, and regularly during treatment.
Maltese: Inqas ma jkun hemm limfoċiti inqas ikun hemm infjammazzjoni, u dan jgħin biex jiġu kkontrollati s-sintomi tal-artrite.
English: 3 x 28 tablets
Maltese: 3 x 28 pillola
English: (Invented) name Strength Pharmaceutical form
Maltese: Isem (Inventat) Qawwa
English: 3 years.
Maltese: 10 minuti.
English: Lilly France Zone Industrielle 2 Rue du Colonel Lilly 67640 Fegersheim France
Maltese: Lilly France Zone Industrielle 2 Rue du Colonel Lilly 67640 Fegersheim Franza
English: * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10 %.
Maltese: Komuni ħafna- ≥ 10%; Komuni - > 5% and < 10%.
English: 500 mg
Maltese: INDIVIDWALI 500 mg
English: Dose of Pemetrexed Lilly (mg/m2)
Maltese: Doża ta' Pemetrexed Lilly (mg/m2)
English: 95 % CI for HR
Maltese: 95% CI għal HR
English: Mannitol (E421)
Maltese: 6.1 Lista ta' eċċipjenti Mannitol (E421)
English: LIST OF EXCIPIENTS Mannitol, hydrochloric acid, sodium hydroxide
Maltese: Mannitol, hydrochloric acid, sodium hydroxide.
English: The other ingredients are mannitol (E421), hydrochloric acid and sodium hydroxide (see section 2 “Pemetrexed Lilly contains sodium”)
Maltese: Is-sustanzi l-oħra huma mannitol (E421), hydrochloric acid u sodium hydroxide (ara sezzjoni 2 “Pemetrexed Lilly fih sodium”).
English: Pemetrexed Lilly contains sodium
Maltese: Pemetrexed Lilly fih sodium
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 l istudju kien ta' 64.3% għal pemetrexed u 71.7% għal plaċebo.
English: N = 863 0.94
Maltese: N=863 0.94a
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 September 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 14 ta' Settembru 2015
English: 75 % of previous dose
Maltese: 75% tad-doża ta' qabel
English: - Pemetrexed Lilly 100 mg: 1 vial of 10ml - Pemetrexed Lilly 500 mg: 1 vial of 50ml
Maltese: - Pemetrexed Lilly 100 mg: kunjett wieħed ta' 10 mL - Pemetrexed Lilly 500 mg: kunjett wieħed ta' 50 mL
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' erythropoietin/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: *P-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Maltese: * Valuri P < 0.05 meta tqabbel pemetrexed/cisplatin ma' gemcitabine/cisplatin, permezz tal-Fisher Exact test. ** Irreferi għas-CTC (v 2.0; NCI 1998) ta' l-Istitut Nazzjonali tal-Kanċer għal kull Grad ta'
English: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3 %, > 6cycles: 6.4 %: p = 0.046).
Maltese: Ġiet osservata, wisq probabbli kkawżata mill-mediċina taħt studju, żieda fl-inċidenza ta' newtropinja 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 (both Pemetrexed Lilly and cisplatin)
Maltese: 75% tad-doża ta' qabel (kemm Pemetrexed Lilly kif ukoll cisplatin).
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking Pemetrexed Lilly.
Maltese: Supplimentazzjoni b'vitamini: it-tabib tiegħek jordnalek folic acid (vitamina) orali jew xi prodott multivitaminiku li fih folic acid (350 sa 1000 microgramma) li trid tieħu darba kuljum waqt ittrattament b'Pemetrexed Lilly.
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI = 0.84-1.05).
Maltese: Studju ta' Fażi 3, open-label, randomised, magħmul f'ħafna ċentri b'pemetrexed flimkien ma' cisplatin kontra gemcitabine flimkien ma' cisplatin f'pazjenti b'kanċer tal-pulmun mhux b'ċelluli żgħar (NSCLC) lokalment avanzat jew metastatiku (Stadju IIIb jew IV) u li qatt ma ħadu ebda kimoterapija, wera li pemetrexed flimkien ma' cisplatin (popolazzjoni bl-Intenzjoni Li Tikkura (ITT) n = 862) laħaq l-endpoint primarju u wera effikaċja klinika simili għal gemcitabine flimkien ma' cisplatin (ITT n=863) fis-sopravivenza totali (proporzjon aġġustat ta' riskju 0.94; 95% CI = 0.841.05).
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 ( > 1/1,000 sa < 1/100), Rari ( > 1/10,000 sa < 1/1,000), Rari ħafna (≤ 1/10,000) u mhijiex magħrufa (ma tistax tittieħed stima mit-tagħrif disponibbli).
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 lhalf-life ta' l-eliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni tal-kliewi normali (tneħħija tal-krejatinina ta' 90 mL/min).
English: Concomitant yellow fever vaccine (see section 4.5).
Maltese: Vaċċin tal-yellow fever fl-istess żmien (ara Sezzjoni 4.5). 4.4
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95 % CI = 0.94-1.15), and overall response rate was 30.6 % (95 % CI = 27.3-33.9) for pemetrexed plus cisplatin versus 28.2 % (95 % CI = 25.0-31.4) for gemcitabine plus cisplatin.
Maltese: Il-medjan ta' PFS kien ta' 4.8 xhur għal pemetrexed flimkien ma' cisplatin kontra 5.1 xhur għal gemcitabine flimkien ma' cisplatin (proporzjon aġġustat ta' riskju 1.04; 95% CI = 0.94-1.15), u r-rata ta' rispons totali kien 30.6% (95% CI = 27.3- 33.9) għal pemetrexed flimkien ma' cisplatin kontra 28.2% (95% CI = 25.
English: - if you have recently received or are about to receive a vaccine against yellow fever.
Maltese: - jekk ħadt dan l-aħħar jew dalwaqt ser tieħu tilqima kontra l-yellow fever.
English: Pemetrexed Lilly 100 mg contains less than 1 mmol (23 mg) sodium per vial, i.e. essentially ‘sodiumfree'.
Maltese: Pemetrexed Lilly 100 mg fih inqas minn mmol 1 ta' sodium (23 mg) f'kull kunjett, i.e. essenzjalment huwa ‘ħieles mis-sodium'.
English: Marketing Authorisation Holder Eli Lilly Nederland B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-suq Eli Lilly Nederland B.V.
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: 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 b'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).
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa pazjent 1 minn kull 1,000)
English: Pemetrexed Lilly.
Maltese: Tużax Pemetrexed Lilly
English: Other (N = 252)
Maltese: (N=252)
English: ** In the pemetrexed/cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Maltese: ** Fil-fergħa ta' pemetrexed/cisplatin, ntgħażlu bl-addoċċ u kkurati (N = 225) u mogħtija suppliment tul it-terapija kollha (N = 167)
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Lilly.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' Pemetrexed Lilly.
English: Overall response rate** (95 % CI)
Maltese: Log Rank p-value* Ir-rata ta' rispons globali** (95% CI)
English: Of the randomised patients, 44.9 % had a complete/partial response and 51.9 % had a response of stable disease to pemetrexed plus cisplatin induction.
Maltese: Mill-pazjenti li ġew magħżula b'mod arbitrarju, 44.9% kellhom rispons komplet/parzjali u 51.9% kellhom rispons ta' marda stabbli għall-kura inizjali ta' pemetrexed flimkien ma' cisplatin.
English: Other medicines and Pemetrexed Lilly
Maltese: Mediċini oħra u Pemetrexed Lilly
English: 95% CI = 1.08-2.26, p = 0.018).
Maltese: = 0.65 - 0.95; p = 0.01192.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Lilly and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Lilly treatment).
Maltese: B12 (1000 microgramma) fil-ġimgħa ta' qabel li tingħata Pemetrexed Lilly u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura b'Pemetrexed Lilly).
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, folic acid analogues, ATC code: L01BA04
Maltese: Sustanzi antineoplastiċi, antimetaboliti, analogi ta' folic acid, Kodiċi
English: EMPHACIS, a multicentre, randomised, single-blind phase 3 study of pemetrexed plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with pemetrexed and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone.
Maltese: EMPHACIS, studju ta' fażi 3, single-blind, magħmul f'ħafna ċentri, randomised,b' pemetrexed flimkien ma' cisplatin kontra cisplatin, f'pazjenti b'mesoteljoma plewrali malinna u li ma kienu ħadu ebda kimoterapija oħra,wera li pazjenti kkurati b'pemetrexed u cisplatin kellhom medjan ta' vantaġġ ta' sopravivenza klinikament sinifikanti ta' 2.8 xhur fuq pazjenti li rċevew cisplatin waħdu.
English: Pemetrexed Lilly 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Maltese: Pemetrexed Lilly 500 mg: Kull kunjett fih 500 milligramm ta' pemetrexed (bħala pemetrexed disodium)
English: 50 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: 100% tad-doża ta' qabel a Kriterji ta' Tossiċità Komuni ta' l-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998) b Minbarra n-newrotossiċità
English: Creatinine clearance should be ≥ 45 mL/min.
Maltese: It-tneħħija tal-krejatinina għandha tkun ta' ≥ 45 mL/min.
English: The relative treatment effect of pemetrexed was internally consistent across subgroups (including disease stage, induction response, ECOG PS, smoking status, gender, histology and age) and similar to that observed in the unadjusted OS and PFS analyses.
Maltese: Dan l-effett fil-kura b'pemetrexed kien konsistenti internament fis-sottogruppi varji (inklużi stadju tal marda, rispons fil-bidu, ECOG PS, stat ta' tipjip, sess, istoloġija u età) u simili għal dak osservat flanaliżi mhux aġġustati ta' OS u PFS.
English: Pemetrexed Lilly 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Maltese: Pemetrexed Lilly 100 mg: Kull kunjett fih 100 milligramm ta' pemetrexed (bħala pemetrexed disodium)
English: After reconstitution (see section 6.6), each vial contains 25 mg/mL of pemetrexed.
Maltese: Wara r-rikostituzzjoni (ara sezzjoni 6.6), kull kunjett fih 25 mg/mL ta' pemetrexed
English: After reconstitution, each vial contains 25 mg/mL of pemetrexed.
Maltese: 25 mg/mL pemetrexed.
English: Table 3 - Dose modification table for Pemetrexed Lilly (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: Tabella 3 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Lilly (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Newrotossiċità
English: 50 % of previous dose
Maltese: 50% tad-doża ta' qabel
English: Children and adolescents There is no relevant use of Pemetrexed Lilly in the paediatric population
Maltese: Tfal u adolexxenti M'hemm ebda użu rilevanti ta' Pemetrexed Lilly fil-popolazzjoni pedjatrika.
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Lilly is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: F'pazjenti kkurati għall-kanċer tal-pulmun mhux b'ċelluli żgħar wara kimoterapija preċedenti, id-doża rakkomandata ta' Pemetrexed Lilly hi ta' 500 mg/m2 BSA mogħtija b'infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated
Maltese: Effikaċja ta' pemetrexedma' cisplatin vs. cisplatin f'mesoteljoma plewrali malinna
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (n = 441) with that of placebo plus BSC (n = 222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first line doublet therapy containing Cisplatin or Carboplatin in combination with Gemcitabine, Paclitaxel, or Docetaxel.
Maltese: (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' manteniment b' pemetrexedflimkien mal-aħjar kura ta' sosteniment (AKS) (n = 441) ma' dik ta' plaċebo flimkien ma' AKS (n = 222) f'pazjenti b'Kanċer tal-Pulmun Mhux b'Ċelluli Żgħar (NSCLC) lokalment avanzat (Stadju IIIB) jew metastatiku (Stadju IV) u li magħmlux progress wara 4 ċikli ta' kura doppja (doublet) tal-ewwel linja li kien fiha Cisplatin jew Carboplatin flimkien ma' Gemcitabine, Paclitaxel jew Docetaxel.
English: Pemetrexed Lilly 500 mg contains approximately 54 mg sodium per vial.
Maltese: Kull kunjett fih madwar 54 mg ta' sodium.
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 839 patients with NSCLC who were randomized to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomized to receive cisplatin and gemcitabine.
Maltese: It-tabella hawn taħt tati l-frekwenza u s-severità ta' l-effetti mhux mixtieqa li huma kkunsidrati possibbilment relatati ma' l-mediċina taħt studju u li ġew irrapportati f'> 5% ta' 839 pazjent b'NSCLC li b'mod arbitrarju ntgħażlu biex jirċievu cisplatin u pemetrexed u 830 pazjent b'NSCLC li b'mod arbitrarju ntgħażlu biex jirċievu cisplatin u gemcitabine.
English: When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature (2 °C to 8 °C).
Maltese: Meta ppreparati kif suppost, l-istabbilità kimika u fiżika ta' waqt l-użu, tas-soluzzjonijiet rikostitwiti u ta' infużjoni ta' pemetrexed, ġiet ippruvata għal 24 siegħa f'temperatura ta' friġġ (2 °C sa 8 °C).
English: Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and acetylsalicylic acid (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Maltese: Pazjenti b'insuffiċjenza renali minn ħafifa għal moderata (tneħħija ta' krejatinina bejn 45 u 79 mL/min) għandhom jevitaw li jieħdu mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs) bħal ibuprofen, u acetylsalycilic acid (> 1.3 g kuljum) minn jumejn qabel, dakinhar, u sa jumejn wara lgħoti ta' pemetrexed (ara sezzjoni 4.5).
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60, 95% CI = 0.49-0.73, p < 0.00001).
Maltese: pemetrexed fuq dik il-fergħa ta' plaċebo (n = 581, popolazzjoni analizzata indipendentement; medjan ta' 4.0 xhur u 2.0 xhur, rispettivament) (hazard ratio = 0.60, 95% CI = 0.49-0.73, p < 0.00001).
English: Pemetrexed has a steady-state volume of distribution of 9 L/m2.
Maltese: pazjent bil-kanċer li kellhom diversi tumuri solidi.Pemetrexed għandu volum tad-distribuzzjoni fiss ta' 9 L/m2 .
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: mesoteljoma plewrali malinna kien dimonstrat fil-fergħa ta' pemetrexed/cisplatin (212-il pazjent)meta kkomparat mal-fergħa ta' cisplatin waħdu (218-il pazjent) meta ġie użat il-Lung Cancer Symptom Scale.
English: Side effects with Pemetrexed Lilly may include:
Maltese: Effetti sekondarji ta' Peremetrex Lilly jistgħu jinkludu:
English: Pemetrexed Lilly (pemetrexed) is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Maltese: Pemetrexed Lilly (pemetrexed) hija sustanza antifolatika, antikanċeroġenika u għandu iżjed minn obbjettiv wieħed.
English: Response (n: qualified for response) Response rate (%) (95 % CI) Stable disease (%)
Maltese: Persentaġġ ta' respons (%) (95% CI)
English: A total of 169 patients (47.1 %) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed.
Maltese: Total ta' 169 pazjent (47.1%) spiċċaw ≥ 6 ċikli ta' kura ta' manteniment b'pemetrexed , li jirrappreżentaw għallinqas 10 ċikli sħaħ ta' pemetrexed.
English: When prepared as directed, reconstituted and infusion solutions of Pemetrexed Lilly contain no antimicrobial preservatives.
Maltese: Meta ppreparati kif suppost, is-soluzzjonijiet rikostitwiti u ta' infużjoni ta' Pemetrexed Lilly ma jkun fihom ebda preservattiv antimikrobiku.
English: Data from the originator medicinal product identified 141 cases of pigmentation disorders such as hyperpigmentation (n=48) and pigmentation disorders NEC (n=80) corresponding mostly to blackish or increased pigmentation, positive de-challenge and positive re-challenge in a number of cases was also described.
Maltese: Tagħrif mill-prodott mediċinali oriġinali identifika 141 każ ta' disturbi ta' pigmentazzjoni bħal iperpigmentazzjoni (n=48) u disturbi ta' pigmentazzjoni NEC (n=80) li jikkorrispondu l-aktar għal pigmentazzjoni li tkun aktarx sewda jew li tkun qed tiżdied, f'numru ta' każijiet ġie deskritt ukoll tnaqqis fil-pigmentazzjoni meta titwaqqaf il mediċina u żieda fil-pigmentazzjoni meta din terġa' tingħata.
English: Adjusted hazard ratio (HR) (95 % CI)
Maltese: Sopravivenza globali medjana (xhur) (95% CI)