FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy and safety of Resolor in patients (aged ≥18 or older) with chronic constipation, were evaluated in a 24 week multicentre, randomised, double-blind, placebo controlled study (N=361).
Maltese: L-effikaċja u s-sigurtà ta' Resolor f'pazjenti (ta' ≥18-il sena) bi stitikezza kronika ġew evalwati fi studju b'aktar minn ċentru wieħed, randomizzat, double-blind, ikkontrollat bi plaċebo ta' 24 ġimgħa (N=361).
English: Population pharmacokinetics
Maltese: Proprjetajiet farmakokinetiċi tal-popolazzjoni
English: Effects of prucalopride on pharmacokinetics of other medicinal products A 30% increase in plasma concentrations of erythromycin was found during prucalopride co-administration.
Maltese: L-effetti ta' prucalopride fuq il-farmakokinetika ta' prodotti mediċinali oħrajn Instabet żieda ta' 30% fil-konċentrazzjoni ta' erythromycin fil-plażma waqt l-għoti flimkien ma' prucalopride.
English: The difference between treatment groups in the average weekly frequency of ≥3 SCBMs per week was not statistically significant over Weeks 1-12 which is inconsistent with the 5 other multicentre, randomised, double-blind, 12-week placebo controlled studies demonstrating efficacy at this timepoint in adult patients.
Maltese: Id-differenza bejn il-gruppi ta' kura filfrekwenza medja ta' kull ġimgħa ta' ≥3 SCBM ma kinitx statistikament sinifikanti tul il-Ġimgħat 112, u dan huwa inkonsistenti mal-5 studji l-oħrajn kkontrollati bi plaċebo ta' 12-il ġimgħa, b'aktar minn ċentru wieħed, randomizzati, double-blind u dan juri effikaċja f'dan il-punt ta' żmien f'pazjenti adulti.
English: One film-coated tablet of Resolor 2 mg contains 2 mg prucalopride (as succinate).
Maltese: Pillola waħda miksija b'rita ta' Resolor 2 mg fiha 2 mg ta' prucalopride (bħala succinate).
English: Therapeutic doses of probenecid, cimetidine, erythromycin and paroxetine did not affect the pharmacokinetics of prucalopride.
Maltese: Dożi terapewtiċi ta' probenecid, cimetidine, erythromycin u paroxetine ma affettwawx il-propretajiet farmakokinetiċi ta' prucalopride.
English: The plasma protein binding of prucalopride is about 30%.
Maltese: It-twaħħil ta' prucalopride mal-proteini tal-plażma hu ta' madwar 30%.
English: In vitro, only at concentrations exceeding its 5-HT4 receptor affinity by at least 150-fold, affinity for other receptors was detected.
Maltese: In vitro, kien biss f'konċentrazzjonijiet li qabżu l-affinità tiegħu għarriċettur 5-HT4 b'mill-anqas 150 darba, li kienet rilevata affinità għal riċetturi oħra.
English: Similar results were observed at Week 12: 46.9% in 2 mg Resolor patients versus 19.0% in placebo patients (p<0.001 vs placebo).
Maltese: Riżultati simili ġew osservati f'Ġimgħa 12: 46.9 % f'pazjenti li kienu qed jieħdu 2 mg ta' Resolor kontra 19.0 % f'pazjenti fuq ilplaċebo (p<0.
English: The following side effects have been reported commonly (may affect up to 1 in 10 people): decreased appetite, dizziness, vomiting, disturbed digestion (dyspepsia), windiness, abnormal bowel sounds, tiredness.
Maltese: L-effetti sekondarji li ġejjin ġew irrappurtati b'mod komuni (jistgħu jafettwaw sa persuna 1 minn kull 10): tnaqqis tal-aptit, sturdament, remettar, disturb fid-diġestjoni (dispepsija), gass, ħsejjes mhux normali mill-imsaren, għeja.
English: A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2).
Maltese: Hi rakkomandata doża ta' 1 mg f'individwi li jkollhom indeboliment sever tal-kliewi (ara sezzjoni 4.2).
English: There is limited information on the safety and efficacy of Resolor for use in patients with severe and clinically unstable concomitant disease (e.g. cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders).
Maltese: Hemm informazzjoni limitata dwar is-sigurtà u l-effikaċja ta' Resolor għall-użu f'pazjenti b'mard sever u klinikament instabbli fl-istess ħin (eż. mard kardjovaskulari jew tal-pulmun, disturbi newroloġiċi jew psikjatriċi, kanċer jew AIDS u disturbi endokrinali oħra).
English: CARTON
Maltese: Mejt
English: Furthermore, giant migrating contractions are induced by prucalopride.
Maltese: Barra minn hekk, prucalopride jikkawża kontrazzjonijiet migranti kbar ħafna.
English: Pollakiuria
Maltese: Pollakjurja
English: The effect of Resolor on spontaneous bowel movements (SBM) also proved to be statistically superior to placebo for the portion of patients that had an increase of ≥1 SBM/week over the 12-week treatment period.
Maltese: Ġie stabbilit ukoll li l-effett ta' Resolor fuq ippurgar spontanju (spontaneous bowel movementsSBM) kien statistikament superjuri għall-plaċebo għall-proporzjon ta' pazjenti li kellhom żieda ta' ≥1 SBM/ġimgħa fuq il-perjodu ta' kura ta' 12-il ġimgħa.
English: Resolor 1 mg film-coated tablets Resolor 2 mg film-coated tablets prucalopride
Maltese: Resolor 1 mg pilloli miksijin b'rita Resolor 2 mg pilloli miksijin b'rita prucalopride
English: - Renal impairment requiring dialysis.
Maltese: - Indeboliment tal-kliewi li jeħtieġ dijaliżi.
English: The primary efficacy endpoint was the proportion (%) of subjects that reached normalisation of bowel movements defined as an average of three or more spontaneous, complete bowel movements (SCBM) per week over the 12-week treatment period.
Maltese: Il-punt aħħari primarju tal-effikaċja kien ilproporzjon (%) ta' individwi li laħqu normalizzazzjoni tal-movimenti tal-imsaren definita bħala medja ta' tliet movimenti jew aktar spontanji kompleti tal-imsaren (SCBM) kull ġimgħa tul il-perjodu talkura ta' 12-il ġimgħa.
English: Prucalopride o.d. displays time-independent kinetics during prolonged treatment.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: Prucalopride is rapidly absorbed; after a single oral dose of 2 mg in healthy subjects, Cmax was attained in 2-3 hours.
Maltese: Prucalopride jiġi assorbit malajr; wara doża orali waħda ta' 2 mg f'individwi b'saħħithom, is-Cmax intlaħqet fi żmien 2-3 sigħat.
English: These are equivalent to the colonic mass movements in humans, and provide the main propulsive force to defecation.
Maltese: Dawn huma ekwivalenti għall-movimenti tal-massa kolonika fil-bnedmin, u jipprovdu lforza propulsiva prinċipali għall-ippurgar.
English: In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
Maltese: F'każ ta' dijarrea akuta, tista' tonqos l-effikaċja tal-kontraċettivi orali u għalhekk huwa rakkomandat li jintuża metodu kontraċettiv addizzjonali sabiex ikun evitat il-falliment possibbli tal-kontraċezzjoni orali (ara l-informazzjoni dwar il-preskrizzjoni tal-kontraċettiv orali).
English: A large fraction of the active substance is excreted unchanged (60-65% of the administered dose in urine and about 5% in faeces).
Maltese: Porzjon kbir mis-sustanza attiva jitneħħa mhux mibdul (60-65% tad-doża mogħtija fl-awrina u madwar 5% fl-ippurgar).
English: Each film-coated tablet contains 2 mg prucalopride (as succinate).
Maltese: Kull pillola miksija b'rita fiha 2 mg ta' prucalopride (bħala prucalopride succinate).
English: The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (i.e., responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the prucalopride (25.1%) and placebo (20.7%) treatment groups.
Maltese: Il-proporzjon ta' pazjenti bi frekwenza medja ta' ≥3 movimenti spontanji kompleti talimsaren (SCBM- Spontaneous Complete Bowel Movements) fil-ġimgħa (jiġifieri, dawk li wieġbu) tul il-fażi ta' kura double-blind ta' 24 ġimgħa ma kienx statistikament differenti (p=0.367) bejn il-grupp ta' kura ta' Resolor (25.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (including pregnancy, embryonal/foetal development, parturition or postnatal development) (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq issistema riproduttiva (inkluż fuq it-tqala, l-iżvilupp tal-embriju/fetu, il-ħlas jew l-iżvilupp wara ttwelid) (ara 5.3). Resolor mhuwiex rakkomandat waqt it-tqala u f'nisa li jistgħu joħorġu tqal li ma jużawx kontraċettiv.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Maltese: Informazzjoni mhux klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva, ma turi l-ebda periklu speċjali għall-bnedmin u għall-iżvilupp.
English: The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months.
Maltese: L-effikaċja ta' prucalopride ġiet stabbilita fi studji double-blind, ikkontrollati bi plaċebo, li damu għaddejjin sa 3 xhur.
English: Caution should be exercised when prescribing Resolor to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment (see section 4.2).
Maltese: Għandu jkun hemm kawtela meta tingħata riċetta għal Resolor lil pazjenti b'indeboliment sever talfwied (Child-Pugh klassi C) minħabba dejta limitata f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 4.2).
English: Older people (>65 years): Start with 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily.
Maltese: Persuni akbar fl-età (>65 sena): Ibda b'doża ta' 1 mg darba kuljum (ara sezzjoni 5.2); jekk ikun meħtieġ, id-doża tista' tiżdied għal 2 mg darba kuljum.
English: Each film-coated tablet contains 2 mg prucalopride (as succinate)
Maltese: Kull pillola miksija b'rita fiha 2 mg ta' prucalopride (bħala succinate)
English: This study did not show significant differences between Resolor and placebo at either dose, based on mean QT measurements and outlier analysis.
Maltese: Dan l-istudju ma weriex differenzi sinifikanti bejn Resolor u l-plaċebo b'kull doża, ibbażat fuq il-kejl medju tal-QT u outlier analysis.
English: Resolor contains the active substance prucalopride.
Maltese: X'inhu Resolor u gћalxiex jintuża Resolor fih is-sustanza attiva prucalopride.
English: Each film-coated tablet contains 1 mg prucalopride (as succinate)
Maltese: Kull pillola miksija b'rita fiha 1 mg ta' prucalopride (bħala succinate)
English: EU/1/09/581/001 (28 tablets) EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/007 (84 tablets)
Maltese: EU/1/09/581/001 (28 pillola) EU/1/09/581/003 (7 pilloli) EU/1/09/581/005 (14-il pillola)
English: EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/002 (28 tablets) EU/1/09/581/008 (84 tablets)
Maltese: EU/1/09/581/004 (7 pilloli) EU/1/09/581/006 (14-il pillola) EU/1/09/581/002 (28 pillola)
English: In case of prolonged treatment, the benefit should be reassessed at regular intervals.
Maltese: Fil-każ ta' kura fit-tul, il-benefiċċju għandu jerġa' jiġi evalwat f'intervalli regolari.
English: EU/1/09/581/002 (28 tablets) EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/008 (84 tablets)
Maltese: EU/1/09/581/002 (28 pillola) EU/1/09/581/004 (7 pilloli) EU/1/09/581/006 (14-il pillola)
English: The primary endpoint of the study was met: a statistically significantly higher percentage of subjects in the Resolor group (37.9%) had an average of ≥3 SCBMs/week compared with subjects in the placebo treatment group (17.7%) (p<0.0001) over the 12-week double-blind treatment period.
Maltese: Il-punt aħħari primarju ntlaħaq: perċentwal statistikament ogħla b'mod sinifikanti ta' individwi fil-grupp ta' Resolor (37.9%) kellhom medja ta' ≥3 SCBMs/ġimgħa meta mqabbel ma' individwi fil-grupp ta' kura bi plaċebo (17.7%) (p <0.
English: Renal excretion is the main route of elimination of prucalopride (see section 5.2).
Maltese: It-tneħħija mill-kliewi hi r-rotta prinċipali tat-tneħħija ta' prucalopride (ara sezzjoni 5.2).
English: EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/001 (28 tablets) EU/1/09/581/007 (84 tablets)
Maltese: EU/1/09/581/003 (7 pilloli) EU/1/09/581/005 (14-il pillola) EU/1/09/581/001(28 pillola)
English: Paediatric population: Resolor should not be used in children and adolescents younger than 18 years (see section 5.1).
Maltese: Resolor ma għandux jintuża fi tfal u adolexxenti li għandhom inqas minn 18il sena (ara sezzjoni 5.1).
English: At Week 4, the proportion of patients with an improvement of ≥1 versus baseline in the Patient Assessment of Constipation-Quality of Life satisfaction subscale (PAC-QOL) was 47.7% in patients treated with Resolor 2 mg compared with 20.2% in patients on placebo.
Maltese: 7 % f'pazjenti kkurati b'Resolor 2 mg meta mqabbla ma' 20.2 % f'pazjenti fuq il-plaċebo.
English: The following uncommon side effects have also been seen (may affect up to 1 in 100 people): tremors, pounding heart, rectal bleeding, increase in frequency of passing urine (pollakiuria), fever and feeling unwell.
Maltese: Dehru wkoll l-effetti sekondarji mhux komuni li ġejjin (jistgħu jafettwaw sa persuna 1 minn kull 100): rogħda, qalb tħabbat bil-qawwi, fsada rektali, żieda fil-frekwenza li tgħaddi l-awrina (pollakjurja), deni u ma tħossokx tajjeb.
English: Metabolism is not the major route of elimination of prucalopride.
Maltese: Il-metaboliżmu mhuwiex ir-rotta prinċipali tat-tneħħija ta' prucalopride.
English: Dizziness
Maltese: Bijotrasformazzjoni
English: It is extensively excreted unchanged in urine (approximately 60% of the dose) and in vitro metabolism is very slow.
Maltese: Jitneħħa b'mod estensiv mhux mibdul fl-awrina (madwar 60% tad-doża) u l-metaboliżmu in vitro hu baxx ħafna.
English: Cases of spontaneous abortion have been observed during clinical studies, although, in the presence of other risk factors, the relationship to prucalopride is unknown.
Maltese: Ġew osservati każijiet ta' abort spontanju matul l-istudji kliniċi, għalkemm, fil-preżenza ta' fatturi ta' riskju oħrajn, mhix magħrufa rrelazzjoni ma' prucalopride.
English: Iffeza 50 Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation
Maltese: Mikrogramm/5 Mikrogramm pro Sprühstoß Druckgasinhalation
English: Target species Route of administration
Maltese: Mod ta' Amministrazzjoni Ippakkjar
English: Content Package size
Maltese: Kontenut Daqs talpakkett Perjodu ta' Tiżmim
English: 10 glass vials
Maltese: Numru ta' l-UE Isem kummerċjali Qawwa
English: An updated version of the Risk Management Plan will be submitted to National Competent Authorities within 3 months of the Commission Decision for this procedure, to reflect the updated information on the paediatric population as agreed by CHMP.
Maltese: Verżjoni aġġornata tal-Pjan tal-Ġestjoni tar-Riskji sejra tiġi sottomessa lill-Awtoritajiet Kompetenti Nazzjonali fi żmien 3 xhur mid-Deċiżjoni tal-Kummissjoni għal din il-proċedura, sabiex tirrifletti linformazzjoni aġġornata dwar il-popolazzjoni pedjatrika kif qabel fuqha s-CHMP.
English: Conditions of the marketing authorisations
Maltese: Kundizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: ITT population (N=1725)
Maltese: Popolazzjoni ITT (N = 1725)
English: Excipients: mannitol, hydrochloric acid, sodium hydroxide (E524).
Maltese: Eċċipjenti: mannitol, hydrochloric acid, sodium hydroxide (E524).
English: ≥ 50,000/mm
Maltese: ≥ 100,000 ċellula/mm
English: Dose of Pemetrexed Krka (mg/m
Maltese: Doża ta' Pemetrexed Krka (mg/m
English: See section 2 "Pemetrexed Krka contains sodium".
Maltese: Ara taqsima 2 “Pemetrexed Krka fih sodium”.
English: ** which is derived from the term “renal/genitourinary other”.
Maltese: ** li ġejja mit-terminu “renali/ġenito-awrinarji oħrajn”.
English: *p-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test.
Maltese: * Valuri P < 0.05 meta tqabbel pemetrexed/cisplatin ma' gemcitabine/cisplatin, permezz tal-Fisher Exact test.
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be ≤ 3-times upper limit of normal.
Maltese: L- alkaline phosphatase (AP), l- aspartate aminotransferase (AST jew SGOT) u l- alanine aminotransferase (ALT jew SGPT) għandhom ikunu ≤ 3 darbiet il-limitu massimu tan-normal.
English: The total bilirubin should be ≤ 1.5-times upper limit of normal.
Maltese: It-total ta' bilirubina għandu jkun ≤ 1.5 darbiet il-limitu massimu tan-normal.
English: Pemetrexed + Cisplatin Gemcitabine + Cisplatin
Maltese: Gemcitabine + Cisplatin
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' endpoints ta' effikaċjaprimarjafil-popolazzjoni Kwalifikata b'Protokoll (PQ).
English: Pemetrexed Krka contains sodium
Maltese: Pemetrexed Krka fih sodium
English: Frequenc
Maltese: Frekwenza
English: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Maltese: Id-datatal-PFS ġew parzjalment ikkonfermati minn stħarriġ indipendenti (400/1725 pazjent ġew magħżula b'mod arbitrarjugħall-istħarriġ).
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: 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: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04.
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, analogi ta' folic acid, Kodiċi ATC:
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: 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) - Not known (cannot be estimated from the 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) - Mhijiex magħrufa (ma tistax tiġi stimata mit-tagħrif disponibbli).
English: Efficacy of pemetrexed vs. docetaxel in NSCLC - ITT population
Maltese: Effikaċja ta' pemetrexed vs docetaxel f'popolazzjoni ITT - NSCLC Pemetrexed
English: 3 and platelets should be ≥ 100,000 cells/mm Creatinine clearance should be ≥ 45 ml/min.
Maltese: 3 u l plejtlits għandhom ikunu ≥ 100,000 ċellula/mm It-tneħħija tal-krejatinina għandha tkun ta' ≥ 45 ml/min.
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 ta' leliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni tal-kliewi normali (tneħħija talkrejatinina ta' 90 ml/min).
English: What Pemetrexed Krka contains - The active substance is pemetrexed.
Maltese: Is-sustanza attiva hi pemetrexed.
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) (E524)
Maltese: Hydrochloric acid (għall-aġġustament ta' pH) Sodium hydroxide (għall-aġġustament ta' pH) (E524)
English: Fisher's exact pvalue*
Maltese: Fisher's exact p-value*
English: A multi-centre, 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 (HR) 0.94; 95% CI=0.84-1.05).
Maltese: Studju multiċentrali ta' Fażi 3, open-label, randomised, 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 lendpoint primarju u wera effikaċja klinika simili għal gemcitabine flimkien ma' cisplatin (ITT N=863) fis-sopravivenza totali (proporzjon aġġustat ta' riskju (HR) 0.94; 95% CI=0.84-1.05).
English: Abbreviation: CI = confidence interval.
Maltese: CI = Intervall ta' Kunfidenza
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 Krka.
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 Krka.
English: Pemetrexed/Cisplati n (N=839)
Maltese: Pemetrexed/ Cisplatin (N=839)
English: Large Cell Carcinoma
Maltese: Iam Cell Cardnnma
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml pemetrexed.
Maltese: Wara r-rikostituzzjoni (ara taqsima 6.6), kull kunjett ikun fih 25 mg/ml pemetrexed.
English: • Median (m)
Maltese: NUMRU(I)
English: ****Combined term includes increased serum/blood creatinine, decreased glomerular filtration rate, renal failure and renal/genitourinary- other.
Maltese: **** Terminu li jiġbor kollox u jinkludi żieda fil-kreatinina fis-serum/demm, tnaqqis fir-rata ta' filtrazzjoni glomerulari, insuffiċjenzi renali u renali/ġenitourinarji-oħrajn.
English: Excipient with known effect Each vial contains approximately 54 mg (2.35 mmol) sodium.
Maltese: Eċċipjent b'effett magħruf Kull kunjett fih madwar 54 mg (2.35 mmol) ta' sodium.
English: Clinically relevant CTC toxicity that was reported in <1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Maltese: Tossiċità CTC klinikament rilevanti li ġiet irrapportata f' < 1% tal-pazjenti li b'mod arbitrarju ġew magħżula biex jirċievu pemetrexed jinkludu: reazzjoni allerġika/sensittività eċċessiva, eritema multiforme, arritmja supraventrikulari u emboliżmu pulmunarju.
English: For instructions on reconstitution and dilution of Pemetrexed Krka before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwizzjoni ta' Pemetrexed Krka qabel l-amministrazzjoni, ara sezzjoni 6.6.
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: 75% of previous dose (both Pemetrexed Krka and cisplatin)
Maltese: 75 % tad-doża ta' qabel (kemm Pemetrexed Krka kif ukoll cisplatin)
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=0.046).