FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Maltese: Fi studji kliniċi, ma kienx hemm indikazzjoni li pazjenti ta' 65 sena jew aktar għandhom riskju akbar ta' reazzjonijiet avversi meta mqabbla ma' pazjenti li għandhom inqas minn 65 sena.
English: Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n = 164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8 % versus 5.3 %, respectively) and alanine aminotransferase elevation (15.2 % versus 1.9 %, respectively).
Maltese: Tossiċitajiet ta' laboratorju klinikament rilevanti ta' Grad 3 u Grad 4 kienu simili bejn ir-riżultati integrati ta' Fażi 2 minn tliet studji ta' pemetrexed bħala mediċina weħidha (n = 164) u l-istudju ta' Fażi 3 ta' pemetrexed bħala mediċina weħidha deskritta hawn fuq bl-eċċezzjoni ta' newtropenja (12.8 % kontra 5.3 %, rispettivament) u ż-żieda fl-alanine aminotransferase (15.2 % kontra 1.9 %, rispettivament).
English: Alopecia Common Rash/desquamation 6.6
Maltese: Rimettar Mukosite/stomatite 6.8
English: CTC
Maltese: PC GC
English: Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion This medicinal product contains 108 mg sodium per 1,000 mg vial, equivalent to 5.40% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 108 mg sodium f'kull kunjett ta' 1,000 mg, ekwivalenti għal 5.40% talammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult.
English: Each 1,000 mg vial contains approximately 108 mg sodium.
Maltese: Kull kunjett ta' 1,000 mg fih madwar 108 mg ta' sodium.
English: Pemetrexed medac contains sodium
Maltese: Pemetrexed medac fih sodium
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 każwali, 44.9 % kellhom rispons komplet/parzjali u 51.9 % kellhom rispons ta' marda stabbli għall- kura inizjali ta' pemetrexed flimkien ma' cisplatin.
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10 %.
Maltese: SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
English: Pemetrexed is primarily eliminated in the urine, with 70 % to 90 % of the administered dose being recovered unchanged in urine within the first 24 hours following administration.
Maltese: Pemetrexed jiġi primarjament eliminat fl-awrina, b'70 % sa 90 % tad-doża mogħtija rkuprata mingħajr ebda modifikazzjoni fl-awrina flewwel 24 siegħa minn meta tkun ngħatat id-doża.
English: The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N = 519), and compared to patients who received > 6 cycles of pemetrexed (N = 281).
Maltese: L-inċidenza ta' reazzjonijiet avversi ġiet analizzata f'pazjenti li rċevew ≤ 6 ċikli ta' manteniment b'pemetrexed (N = 519), u mqabbla mal-pazjenti li rċevew > 6 ċikli ta' pemetrexed (N = 281).
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett ta' 100 mg, jiġifieri essenzjalment “ħieles mis-sodium”.
English: Your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (3501,000 µg) that you must take once a day while you are taking Pemetrexed medac.
Maltese: It-tabib tiegħek jordnalek folic acid (vitamina) orali jew xi prodott multivitaminiku li fih folic acid (350 - 1,000 µg) li trid tieħu darba kuljum waqt it-trattament b'pemetrexed medac.
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 ikun sit ta' metastasi f'każ ta' tumur.
English: Pemetrexed medac 1,000 mg: Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed medac 1,000 mg: Kull kunjett fih 1,000 mg ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
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, randomizzat, b'pemetrexed flimkien ma' cisplatin kontra cisplatin, f'pazjenti b'mesoteljoma plewrali malinna u li ma kienu ħadu ebda kemoterapija 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: − kidney: abnormal blood tests
Maltese: − kliewi: testijiet tad-demm anormali
English: Pemetrexed medac 100 mg: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed medac 100 mg: Kull kunjett fih 100 mg ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: However patients with hepatic impairment such as bilirubin > 1.5 times the upper limit of normal and/or aminotransferase > 3.0 times the upper limit of normal (hepatic metastases absent) or > 5.0 times the upper limit of normal (hepatic metastases present) have not been specifically studied.
Maltese: Madankollu, ma ġewx studjati speċifikament pazjenti b'indeboliment tal-fwied bħal każijiet ta' bilirubina > 1.5 drabi l-limitu massimu tan-normal u/jew aminotransferase > 3.0 darbiet il-limitu massimu tan-normal (mingħajr metastażi fil-fwied) jew > 5.0 darbiet il-limitu massimu tan-normal (b'metastażi fil-fwied).
English: Each pack consists of one vial containing 100 , 500 or 1,000 mg of pemetrexed.
Maltese: Kull pakkett ta' Pemetrexed medac fih kunjett wieħed li fih 100, 500 jew 1,000 mg ta' pemetrexed.
English: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Maltese: Studju ta' Fażi 3, open-label, randomizzat, magħmul f'ħafna ċentri b'pemetrexed kontra docetaxel f'pazjenti b'NSCLC lokalment avvanzat jew metastatiku wara kemoterapija preċedenti, wera żminijiet medjani ta' sopravivenza ta' 8.3 xhur f'pazjenti kkurati b'pemetrexed (Popolazzjoni bl-Intenzjoni Li Tiġi Kkurata (ITT), n = 283) u 7.9 xhur f'pazjenti kkurati b'docetaxel (ITT n = 288).
English: Children and adolescents There is no relevant use of Pemetrexed medac in the paediatric population.
Maltese: Tfal u adolexxenti M'hemm ebda użu rilevanti ta' Pemetrexed medac fil-popolazzjoni pedjatrika.
English: Pemetrexed medac 500 mg: Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed medac 500 mg: Kull kunjett fih 500 mg ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Pemetrexed in combination with cisplatin
Maltese: Pemetrexed/cisplatin
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 (eliminazzjoni ta' krejatinina ta' bejn 45 u 79 ml/min) għandhom jevitaw li jieħdu mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs) bħal ibuprofen, u acetylsalicylic acid (> 1.3 g kuljum) minn jumejn qabel, dakinhar, u sa jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.5).
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups ITT population and histology subgroups
Maltese: L-Effikaċja ta' pemetrexed + cisplatin vs. gemcitabine + cisplatin fl-linja ta' kura tal-kanċer talpulmun mhux b'ċelluli żgħar- popolazzjoni ITT u sottogruppi istoloġiċi.
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 tagħti l-frekwenza u s-severità tal-effetti mhux mixtieqa li huma kkunsidrati possibbilment relatati mal-mediċina taħt studju u li ġew irrapportati f'>5 % ta' 839 pazjent b'NSCLC li b'mod każwali ntgħażlu biex jirċievu cisplatin u pemetrexed u 830 pazjent b'NSCLC li b'mod każwali ntgħażlu biex jirċievu cisplatin u gemcitabine.
English: Rash/ desquamation Common Pruritus Alopecia
Maltese: Dispepsja/qrusa tal-istonku
English: The median OS for the overall population (n = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95 % CI = 0.65 - 0.95, p = 0.01192).
Maltese: Il-medjan tal-OS tal-popolazzjoni in ġenerali (n = 663) kien ta' 13.4 xhur għall-fergħa ta' pemetrexed u ta' 10.6 xhur għall-fergħa tal-plaċebo, proporzjon tal-periklu = 0.79 (95 % CI = 0.65 - 0.95; p = 0.01192).
English: − conjunctivitis (inflamed eye)
Maltese: − epatite (infjammazzjoni tal-fwied)
English: Pemetrexed medac 100 mg powder for concentrate for solution for infusion This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free'.
Maltese: Pemetrexed medac 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) f'kull kunjett ta' 100 mg, jiġifieri essenzjalment “ħieles mis-sodium”.
English: The recommended dose of Pemetrexed medac is 500 mg/m² of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: Id-doża rakkomandata ta' Pemetrexed medac hi ta' 500 mg/m² tal-erja tas-superfiċje tal-ġisem (BSA) mogħtija bħala infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Vitamin supplementation
Maltese: Il-vitamina
English: Anorexia
Maltese: Tqallih Anoressija
English: − taste change
Maltese: Probabbiltà ta' Sopravivenza
English: Do not use Pemetrexed medac
Maltese: Tużax Pemetrexed medac
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: Studju ta' Fażi 3 kkontrollat bil-plaċebo, open-label, magħmul f'ħafna ċentri u b'mod każwali (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' manteniment b'pemetrexed flimkien 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 avvanzat (Stadju IIIB) jew metastatiku (Stadju IV) u li ma għamlux progress wara 4 ċikli ta' kura doppja (doublet) tal-ewwel linja li kien fiha cisplatin jew carboplatin flimkien ma' gemcitabine, paclitaxel jew docetaxel.
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 fissottogruppi varji (inklużi stadju tal-marda, rispons fil-bidu, ECOG PS, stat ta' tipjip, sess, istoloġija u età) u simili għal dak osservat fl-analiżi mhux aġġustati ta' OS u PFS.
English: Grade
Maltese: LOTT
English: • Non-inferiority p-value (HR) Progression free survival (months)
Maltese: • Il-valur-P (HR) mhux inferjuri Sopravivenza mingħajr progressjoni (xhur)
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: Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Maltese: It-treddigħ għandu jieqaf waqt itterapija b'pemetrexed (ara sezzjoni 4.3).
English: Package leaflet: Information for the user Pemetrexed medac 100 mg powder for concentrate for solution for infusion Pemetrexed medac 500 mg powder for concentrate for solution for infusion Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Informazzjoni għall-utent Pemetrexed medac 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Pemetrexed medac 500 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Pemetrexed medac 1,000 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni pemetrexed
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 %, > 6 cycles: 6.4 %: p = 0.046).
Maltese: B'espożizzjoni itwal ġew osservati żidiet fir-reazzjonijiet avversi (kull Grad).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.
English: Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection.
Maltese: Pemetrexed mhuwiex kompatibbli ma' dilwenti li fihom il-kalċju, inklużi l-injezzjoni ta' Ringer lactated u l-injezzjoni ta' Ringer.
English: Excipient with known effect
Maltese: Effetti sekondarji possibbli
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95 % CI = 0.64 - 0.96, p = 0.0195).
Maltese: Wara li bdiet il-kura b'pemetrexed flimkien ma' cisplatin (4 ċikli), il-kura b'pemetrexed kienet statistikament superjuri għal plaċebo għall-OS (medjan 13.9 xhur kontra 11.0 xhur, proporzjon talperiklu = 0.78, 95 %CI = 0.64 - 0.96, p = 0.0195).
English: *** Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N = 663) and PARAMOUNT continuation pemetrexed maintenance (N = 539) studies.
Maltese: N = 663) u tat-tkomplija ta' manteniment b'pemetrexed (PARAMOUNT: N = 539), b'pemetrexed bħala sustanza waħidha.
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' ≥ 1 % u ≤ 5 % (komuni) tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu cisplatin u pemetrexed jinkludu: insuffiċjenza renali, infezzjoni, deni, newtropenja bid-deni, żieda fl-AST,ALT u GGT, urtikarja, u uġigħ fis-sider.
English: Table 3 - Dose modification table for premetrexed (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: Tabella 3 - Tabella għall-modifikazzjoni fid-doża ta' pemetrexed (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Newrotossiċità
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size
Maltese: ITT = intenzjoni li tikkura; n = daqs talpopolazzjoni kollha
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed medac.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' Pemetrexed medac.
English: An insufficient number of patients has been studied with creatinine clearance of below 45 ml/min.
Maltese: Ġew studjati numru insuffiċjenti ta' pazjenti b'eliminazzjoni tal-krejatinina ta' inqas minn 45 ml/min.
English: Abbreviation: CI = confidence interval * p-value refers to comparison between arms ** In the pemetrexed/cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Maltese: CI = Intervall ta' Kunfidenza * valur-p jirreferi għat-tqabbil ta' bejn iż-żewġ fergħat ** Fil-fergħa ta' pemetrexed/cisplatin, ntgħażlu b'mod każwali u kkurati (N = 225) u mogħtija suppliment tul it-terapija kollha (N = 167)
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 100 mg powder for concentrate for solution for infusion Pemetrexed medac 500 mg powder for concentrate for solution for infusion Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion
Maltese: Pemetrexed medac 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Pemetrexed medac 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Pemetrexed medac 1,000 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
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: L-istudju laħaq ir-riżultat primarju tiegħu u wera titjib statistikament sinifikanti fil-PFS fil-fergħa ta' pemetrexed fuq dik il-fergħa ta' plaċebo (n = 581, popolazzjoni analizzata indipendentement; medjan ta' 4.0 xhur u 2.0 xhur, rispettivament) (proporzjon tal-periklu = 0.60, 95 %CI = 0.49 - 0.73, p < 0.00001).
English: Limited clinical data from a separate randomized, Phase 3, controlled trial, suggest that efficacy data (overall survival, progression free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (n = 41) and patients who did not receive previous docetaxel treatment (n = 540).
Maltese: Informazzjoni klinika limitata, minn studju separat, kkontrollat u, randomizzat ta' Fażi 3, tissuġġerixxi li l-informazzjoni dwar l-effikaċja (sopravivenza totali, sopravivenza mingħajr progressjoni) għal pemetrexed huma simili bejn il-pazjenti li kienu ġew ikkurati qabel b'docetaxel (n = 41) u pazjenti li ma rċevewx kura b'docetaxel qabel (n = 540).
English: C/ Castello, nº1, Pol. Las Salinas,
Maltese: C/ Castello, nº1, Pol. Las Salinas, Sant Boi de Llobregat 08830 Barcelona, Spanja
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Maltese: Il-volum xieraq tas-soluzzjoni rikostitwita ta' pemetrexed irid jerġa' jiġi dilwit sa 100 ml b'soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer's injection and Ringer's injection.
Maltese: Pemetrexed huwa fiżikament inkompatibbli ma dilwenti li fihom calcium, inklużi l-injezzjoni ta'
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' ≥ 1 % u ≤ 5 % (komuni) tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu pemetrexed jinkludu: infezzjoni mingħajr newtropenja, newtropenja bid-deni, reazzjoni allerġika/sensittivita aċċessiva, żieda fil-krejatinina, newropatija motorja, newropatija sensittiva, eritema multiforme u wġigħ addominali.
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (n = 359) with that of placebo plus BSC (n = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of pemetrexed in combination with cisplatin.
Maltese: Studju ta' Fażi 3 kkontrollat bil-plaċebo, double-blind, magħmul f'ħafna ċentri u b'mod każwali (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' tkomplija ta' manteniment b' pemetrexed flimkien ma' BSC (n = 359) ma' dik ta' plaċebo flimkien ma' BSC (n = 180) f'pazjenti li għandhom kanċer talpulmun mhux b'ċelluli żgħar u li jkun lokalment avvanzat (Stadju IIIB) jew metastatiku (Stadju IV), ħlief meta l-istoloġija turi li fil-biċċa l-kbira ċ-ċelluli jkunu tat-tip skwamuż u li ma urew ebda progress wara 4 ċikli ta' kura primarja doppja ta' pemetrexed flimkien ma' cisplatin.
English: − liver: abnormal blood tests
Maltese: − fwied: testijiet tad-demm anormali
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m² infused over a 10-minute period.
Maltese: Wara l-għoti ta' pemetrexed bħala mediċina weħidha, il-proprjetajiet farmakokinetiċi ta' pemetrexed ġew evalwati f'dożi li jvarjaw bejn 0.2 sa 838 mg/m² infużi fuq perijodu ta' għaxar minuti f'426 pazjent bil-kanċer li kellhom diversi tumuri solidi.
English: The recommended dose of cisplatin is 75 mg/m² BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Maltese: Id-doża rakkomandata ta' cisplatin hi ta' 75 mg/m² BSA infuża fuq perijodu ta' sagħtejn madwar 30 minuta wara li tkun saret l-infużjoni ta' pemetrexed fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: − interstitial pneumonitis (scarring of the air sacs of the lung)
Maltese: − pulmonite interstizjali (il-boroż tal-arja ġewwa 'l pulmun irabbu qoxra)
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Maltese: Tossiċità CTC klinikament rilevanti ta' kwalunkwe grad li ġiet irrapportata f'≥ 1 % u ≤ 5 % (komuni) tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu pemetrexed jinkludu: newtropinja bid-deni, infezzjoni, tnaqqis fil-plejtlits, dijarea, stitikezza, alopeċja, ħakk, deni (fin-nuqqas ta' newtropinja), mard fis-superfiċji tal-għajn (inkluża l-konġuntivite), żieda fit-tixrid ta' dmugħ, sturdament u newropatija motorja.