FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no statistically significant effect of tadalafil on levonorgestrel which suggests the effect of ethinylestradiol is due to inhibition of gut sulphation by tadalafil.
Maltese: Tadalafil ma kellu ebda effett statistikament sinifikanti fuq levonorgestrel li jagħti x'jifhem li l-effett ta' ethinylestradiol hu minħabba l-inibizzjoni tas-sulfazzjoni fl-imsaren permezz ta' tadalafil.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Tabulated summary of adverse reactions
Maltese: Sommarju f'forma tabulari tar-reazzjonijiet avversi
English: What ADCIRCA looks like and contents of the pack ADCIRCA 20 mg comes as orange film-coated tablets.
Maltese: ADCIRCA 20 mg jiġi bħala pilloli oranġjo miksijin b'rita.
English: The other ingredients are:
Maltese: Stima tal-frekwenza:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg tadalafil
Maltese: Kull pillola miksija b'rita fiha 20 mg tadalafil
English: EMA/684724/2012 EMEA/H/C/002208
Maltese: EMA/423469/2011EMA/423469/2011 EMEA/H/C/numru tal-prodott
English: The full EPAR for Krystexxa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Krystexxa is a medicine containing the active substance pegloticase.
Maltese: Krystexxa huwa mediċina li fiha s-sustanza attiva pegloticase.
English: Overall, 42% of patients (36 out of 85) given the medicine every two weeks showed a persistent response; the figure for those given Krystexxa every four weeks was 35% (29 out of 84).
Maltese: B'mod ġenerali, 42% tal-pazjenti (36 minn 85) mogħtija l-mediċina kull ġimagħtejn urew rispons persistenti; il-figura għal dawk mogħtija Krystexxa kull erba' ġimgħat kienet ta' 35% (29 minn 84).
English: This is a summary of the European public assessment report (EPAR) for Krystexxa.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Krystexxa.
English: The active substance in Krystexxa, pegloticase, contains an enzyme called uricase.
Maltese: Is-sustanza attiva fi Krystexxa, pegloticase, fiha enzima msejħa uricase.
English: This summary was last updated in 01-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01-2013.
English: The most common serious side effects with Krystexxa are anaphylaxis (a severe allergic reaction), seen in about 7 patients in 100, infusion reactions (including flushing, skin rashes, itching, sweating, chest pain, difficulty in breathing, chills, and raised blood pressure), seen in about 26 patients in 100, and gout flares (worsening of gout symptoms) which were more common in the first 3 months of treatment.
Maltese: L-iktar effetti sekondarji serji komuni bi Krystexxa huma anafilassi (reazzjoni allerġika severa), li dehret f'madwar 7 minn 100 pazjent, reazzjonijiet tal-infużjoni (inklużi ħmura tal-wiċċ, raxxijiet fuq ilġilda, ħakk, għaraq, uġigħ fis-sider, diffikultà fit-teħid tan-nifs, dehxiet, u pressjoni għolja tad-demm), li dehru f'madwar 26 minn 100 pazjent, u intensifikazzjoni tal-gotta (is-sintomi tal-gotta jmorru għallagħar) li kienu iktar komuni fl-ewwel 3 xhur tal-kura.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Krystexxa on 8 January 2013.
Maltese: Il-Kummissjoni Ewropew tat awtorizzazzjoni għat-tqegħid fis-suq madwar l-Unjoni Ewropea għal Krystexxa f' Fit-8 ta' Jannar 2013.
English: Other information about Krystexxa
Maltese: Informazzjoni oħra dwar Krystexxa:
English: The uricase in Krystexxa is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce uricase.
Maltese: Il-uricase fi Krystexxa hija prodotta minn metodu magħruf bħala 'teknoloġija rikombinanti tad-DNA': issir permezz ta' batterju li jirċievi ġene (DNA), u dan jagħmilha kapaċi tipproduċi uricase.
English: Krystexxa must not be used in people who are hypersensitive (allergic) to pegloticase or any of the other ingredients, and in people with a rare blood disorder called glucose 6-phosphate dehydrogenase (G6PD) deficiency (favism) or similar disorders.
Maltese: Krystexxa ma jistax jintuża f'nies b'sensittività eċċessiva (allerġiċi) għal pegloticase jew għal xi sustanza oħra, u f'nies b'disturb rari fid-demm imsejjaħ defiċjenza (faviżmu) ta' glukożju-6-fosfat deidroġenażi (G6PD) jew disturbi simili.
English: What is the risk associated with Krystexxa?
Maltese: X'inhu r-riskju assoċjat ma' Krystexxa?
English: For the full list of side effects reported with Krystexxa, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati bi Krystexxa, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe use of Krystexxa?
Maltese: Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Krystexxa?
English: What is Krystexxa?
Maltese: X'inhu Krystexxa?
English: Krystexxa is only used in patients who cannot control their uric acid levels even at maximum doses of conventional medicines called xanthine oxidase inhibitors, or who are unable to use such medicines.
Maltese: Krystexxa jintuża biss f'pazjenti li ma jistgħux jikkontrollaw il-livelli ta' aċidu uriku tagħhom anki fid-dożi massimi tal-mediċini konvenzjonali msejħa inibituri ta' xanthine oxidase, jew li ma jistgħux jużaw it-tali mediċini.
English: Why has Krystexxa been approved?
Maltese: Għaliex ġie approvat Krystexxa?
English: In Krystexxa, uricase has been attached to a chemical, polyethylene glycol (PEG), which decreases the rate at which uricase is removed from the body, allowing its action to last longer.
Maltese: Fi Krystexxa, uricase twaħħlet ma' sustanza kimika, polyethylene glycol (PEG), li tnaqqas ir-rata li fiha uricase titneħħa mill-ġisem, sabiex l-azzjoni tiegħu tkun tista' ddum iktar.
English: The CHMP concluded that Krystexxa was highly effective in reducing uric acid levels.
Maltese: Is-CHMP ikkonkluda li Krystexxa kien ferm effettiv fit-tnaqqis tal-livelli ta' aċidu uriku.
English: Krystexxa was studied in two main studies involving 225 patients with severe tophaceous gout in whom allopurinol, a xanthine oxidase inhibitor, had previously failed to control their uric acid levels or could not be used due to side effects.
Maltese: Krystexxa ġie studjat f'żewġ studji ewlenin li involvew 225 pazjent b'gotta tofaċea severa li fihom, allopurinol, inibitur ta' xanthine oxidase, ma rnexxilux jikkontrolla l-livelli ta' aċidu uriku tagħhom jew ma setax jintuża minħabba effetti sekondarji.
English: Krystexxa is used to treat adult patients with severe chronic (long-term) tophaceous gout.
Maltese: Krystexxa jintuża biex jikkura pazjenti adulti b'gotta tofaċea kronika severa (fit-tul).
English: Uricase breaks down uric acid into another substance, allantoin, which can be passed out of the body in the urine.
Maltese: Uricase tkisser l-aċidu uriku f'sustanza oħra, allantoin, li tista' tinħareġ mill-ġisem fl-urina.
English: Reactions are more common in patients who develop antibodies (proteins produced by the immune system, the body's natural defences) that reduce the effect of the treatment.
Maltese: Ir-reazzjonijiet huma komuni f'pazjenti li jiżviluppaw antikorpi (proteini prodotti mis-sistema immuni, id-difiżi naturali tal-ġisem) li jnaqqsu l-effett tal-kura.
English: For severely affected patients who cannot be treated effectively with conventional methods, the Committee considered that Krystexxa addressed an unmet need, since no alternative treatments are available.
Maltese: Għal pazjenti milqutin b'mod sever li ma jistgħux jiġu kkurati b'mod effettiv b'metodi konvenzjonali, il-Kumitat qies li Krystexxa indirizza ħtieġa mhux issodisfata, peress li ma hemm disponibbli l-ebda kura alternattiva.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Maltese: Huwa disponibbli bħala konċentrat li jsir soluzzjoni għal infużjoni (bid-dripp) ġol-vina.
English: Although there may be serious side effects (such as infusion reactions and gout flares) these were considered manageable.
Maltese: Għad li jista' jkun hemm effetti sekondarji serji (bħal reazzjonijiet tal-infużjoni u intensifikazzjoni tal-gotta), dawn tqiesu kontrollabbli.
English: How has Krystexxa been studied?
Maltese: Kif ġie studjat Krystexxa?
English: Krystexxa is given as an infusion into a vein every two weeks, at a recommended dose of 8 mg.
Maltese: Krystexxa jingħata bħala infużjoni f'vina kull ġimagħtejn, b'doża rakkomandata ta' 8 mg.
English: Once levels of uric acid are below 6 mg/dl, this allows crystals in the joints to dissolve, slowly shrinking the tophi.
Maltese: Ladarba l-livelli ta' aċidu uriku jaqgħu taħt 6 mg/dl, dan jippermetti sabiex il-kristalli fil-ġogi jinħallu, u bil-mod il-mod iċekknu t-tofi.
English: The effects of Krystexxa were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Krystexxa ġew ittestjati l-ewwel f'mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: The main measure of effectiveness was the number of patients who showed a persistent response to the treatment, defined as uric acid level in the blood below 6 mg/dl for at least 80% of the time during both the third and sixth months of the study.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li wrew rispons persistenti għall-kura, iddefinit bħala livell ta' aċidu uriku fiddemm ta' inqas minn 6 mg/dl għal tal-inqas 80% taż-żmien matul kemm it-tliet xhur kif ukoll is-sitt xhur tal-istudju.
English: Levels of uric acid are therefore measured before each infusion and the doctor should only continue Krystexxa treatment as long as the patient continues to benefit with uric acid levels in the blood lowered below a threshold of 6 mg/dl.
Maltese: Għaldaqstant, il-livelli ta' aċidu uriku jitkejlu qabel kull infużjoni u t-tabib għandu jkompli bil-kura bi Krystexxa sakemm il-pazjent ikompli jibbenefika b'livelli ta' aċidu uriku fid-demm imnaqqas taħt limitu ta' 6 mg/dl.
English: To reduce the risk of these reactions, patients are given other medicines before treatment with Krystexxa.
Maltese: Biex jonqos ir-riskju ta' dawn irreazzjonijiet, il-pazjenti jingħataw mediċini oħrajn qabel il-kura bi Krystexxa.
English: Krystexxa was shown to be more effective than placebo in reducing uric acid levels.
Maltese: Intwera li Krystexxa huwa iktar effettiv mill-plaċebo fit-tnaqqis tal-livelli ta' aċidu uriku.
English: The CHMP therefore decided that Krystexxa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għaldaqstant, is-CHMP iddeċieda li l-benefiċċji ta' Krystexxa huma ikbar mir-riskji tagħha u rrakkomanda li tingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, Hungary
Maltese: Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, L-Ungerija
English: 319, Pinner Road North Harrow Middlesex HA1 4HF United Kingdom
Maltese: 319 Pinner Road North Harrow HA1 4HF
English: Rash Alopecia
Maltese: Rash Alopeċja
English: 10.3 N = 10.3 N = 0.94a
Maltese: 10.9 N=411
English: * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10%.
Maltese: Komuni ħafna- ≥ 10%; Komuni - > 5% and < 10%.
English: It may harm them,
Maltese: Uġigħ, ħmura, nefħa u ġrieħi f'ħalqek Dardir
English: Gemcitabine/ cisplatin (N= 830)
Maltese: Gemcitabine/cisplati n (N = 830)
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment)
Maltese: Hydrochloric acid (E507) (għall-aġġustament tal-pH) Sodium hydroxide (E524) (għall-aġġustament tal-pH)
English: Log Rank p-value* Overall response rate**
Maltese: Log Rank p-value* Ir-rata ta' rispons globali**
English: Dose of Pemetrexed Accord (mg/m2)
Maltese: Doża ta' Pemetrexed Accord (mg/m2)
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Maltese: Effikaċja ta' pemetrexed vs docetaxel f'popolazzjoni ITT - NSCLC Pemetrexed
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 January 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 18 Jannar 2016
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: Pemetrexed Accord contains sodium
Maltese: Pemetrexed Accord fih sodium
English: Response (n: qualified for response) Response rate (%) (95 % CI) Stable disease (%)
Maltese: Respons (n: eliġibbli għar-respons) Persentaġġ ta' respons (%) (95 % CI) marda stabbli(%)
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: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, analogi ta' folic acid, Kodiċi ATC:
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: Adjusted Hazard ratio (HR) (95 %CI)
Maltese: Proporzjon ta' riskju aġġustat (HR) (95% CI)
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 < 1/1,000), Rari ħafna (≤ 1/10,000) u mhijiex magħrufa (ma tistax tiġi stimata mit-tagħrif li hemm disponibbli).
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: Pemetrexed/ cisplatin (N= 839)
Maltese: Frekwenza Avveniment* Pemetrexed/cisplatin (N = 839)
English: How to store Pemetrexed Accord Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
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 drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Maltese: Studji in vitro b'mikrożomi tal-fwied umani juru li mhux previst li pemetrexed jikkawża l-inibizzjoni klinikament sinifikanti tat-tneħħija metabolika ta' mediċini li jkunu metabolizzati b'CYP3A, CYP2D6, CYP2C9, u CYP1A2.
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 fit-aminotransferases, alopeċja, għeja, diżidratazzjoni, raxx, infezzjoni/sepsis u newropatija.
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, mittromboċitopenja u mill-anemija (jew panċitopenja) (ara sezzjoni 4.8).
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 b'pemetrexed.
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
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: Grade toxicit y (%)
Maltese: Kull grad ta' tossiċit à (%)
English: 50 % of previous dose (both Pemetrexed Accord and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: 50 % tad-doża ta' qabel a Kriterji ta' Tossiċità Komuni ta' l-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998)
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: Renal disorders Common Renal disorders**** 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.
Maltese: SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
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: 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 Accord.
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 Accord.
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: Pemetrexed is 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' lactated Ringer u l-injezzjoni ta' Ringer.
English: 75 % of previous dose (both Pemetrexed Accord and cisplatin)
Maltese: 75 % tad-doża ta' qabel (kemm Pemetrexed Accord kif ukoll cisplatin ).
English: Marketing Authorisation Holder Accord Healthcare S.L.U.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-suq Accord Healthcare S.L.U.
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: Common SGPT (ALT) elevation SGOT (AST) elevation
Maltese: Żieda fl-ALT (SGPT) Żieda fl-AST (SGOT)
English: For instructions on reconstitution and dilution of Pemetrexed Accord before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwizzjoni ta' Pemetrexed Accord qabel l-amministrazzjoni, ara sezzjoni 6.6.
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 leffetti tossiċi possibbli tal-kura kontra l-kanċer.
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n= 399, 9.3 versus 8.0 months, adjusted HR= 0.78; 95% CI= 0 .61-1.00, p= 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n= 172, 6.2 versus 7.4 months, adjusted HR= 1.56;95% CI = 1.08-2.26, p = 0.018).
Maltese: Analiżi ta' l-impatt ta' l-istoloġija ta' NSCLC fuq issopravivenza totali wriet id-differenzi ta' pemetrexed kontra docetaxel għal kull tip ta' istoloġija minbarra l-istoloġiji li fil-biċċa l-kbira tagħhom kienu tat-tip squamous (n=399, 9.3 kontra 8.0 xhur, HR aġġustat = 0.78; 95% CI =0 .61-1.00, p = 0.047) u istoloġija ta' karċinoma b'tip ta' ċellula squamous (n=172, 6.2 kontra 7.4 xhur, HR aġġustat = 1.56; 95% CI =1.08-2.26, p = 0.018).
English: Grade 3 or 4 mucositis
Maltese: Grad ta' tossiċit à 3 - 4
English: The other ingredients are mannitol, hydrochloric acid and sodium hydroxide (see section 2).
Maltese: Is-sustanzi l-oħra huma mannitol, hydrochloric acid u sodium hydroxide (ara sezzjoni 2).
English: Other (N=252)
Maltese: Oħrajn (N=252)
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: 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 għallkura inizjali ta' pemetrexed flimkien ma' cisplatin.
English: NSCLC, maintenance treatment JMEN
Maltese: NSCLC, kura ta' manteniment
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: 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).
English: Creatinine clearance should be  45 ml/min.
Maltese: It-tneħħija tal-krejatinina għandha tkun ta' ≥ 45 ml/min.