FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with renal impairment: (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method)
Maltese: Pazjenti b'indeboliment tal-kliewi (Formula Standard Cockcroft & Gault jew Metodu tat-tneħħija misserum Tc99m-DPTA biex tiġi kkalkulata r-Rata ta' Filtrazzjoni Glomerulari) Pemetrexed primarjament jiġi eliminat bla ebda modifikazzjoni permezz ta' tneħħija mill-kliewi.
English: Adjusted Hazard
Maltese: Sopravivenza Totali
English: 9 l/m2.
Maltese: ċellula/mm3.
English: Conjunctivitis (inflamed eye)
Maltese: Konġuntivite (għajn infjammata)
English: Pemetrexed Accord 100 mg contains less than 1 mmol sodium (23 mg) sodium per vial, i.e. essentially ‘sodium-free'.
Maltese: Pemetrexed Accord 100 mg fih anqas minn 1 mmol ta' sodium (23 mg) f'kull kunjett, jiġifieri esenzjalment huwa mingħajr sodium.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: (N = 1725) Adenocarcinoma (N=847)
Maltese: (N=847) Ċellula kbira N=153)
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, hazard ratio= 0.79 (95% CI = 0.65 - 0.95; p = 0.01192).
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: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: 95 % CI for HR Non-inferiority p-value (HR)
Maltese: 95 % CI għal HR
English: Mannitol, hydrochloric acid, sodium hydroxide (see package leaflet for further information).
Maltese: TA' EĊĊIPJENTI Mannitol, hydrochloric acid, sodium hydroxide (għal aktar informazzjoni ara l-fuljett ta' tagħrif).
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 Accord 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Accord 1000 mg: Kull kunjett fih 1000 milligramma ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Liver: abnormal blood tests
Maltese: Kliewi : testijiet tad-demm anormali
English: There were no clinically relevant differences observed for the safety profile of pemetrexed plus cisplatin within the histology subgroups.
Maltese: Ma dehrux differenzi klinikament rilevanti fil-profil ta' sigurtà ta' pemetrexed flimkien ma' cisplatin fis-sottogruppi ta' istoloġija.
English: A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the pemetrexed/cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Maltese: Titjib statistikament sinifikanti fis-sintomi klinikament rilevanti (uġigħ u qtugħ ta' nifs) assoċjati ma' mesoteljoma plewrali malinna kien dimonstrat fil-fergħa ta' pemetrexed/cisplatin (212-il pazjent) meta kkomparat mal-fergħa ta' cisplatin waħdu (218-il pazjent) meta ġie użat il-Lung Cancer Symptom Scale.Differenzi statistikament sinifikanti kienu osservati wkoll fit-testijiet tal-funzjoni tal-pulmun.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Accord and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Accord treatment).
Maltese: B12 (1000 microgramma) fil-ġimgħa ta' qabel li tingħata Pemetrexed Accord u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura b'Pemetrexed Accord).
English: Pemetrexed Accord.
Maltese: X'fih Pemetrexed Accord
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Pemetrexed Accord 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Accord 500 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Accord 1000 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni pemetrexed
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.
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: Other medicines and Pemetrexed Accord
Maltese: Mediċini oħra u Pemetrexed Accord
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - 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: Pemetrexed Accord 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Accord 500 mg: Kull kunjett fih 500 milligramm ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate)
English: 95 % CI for median
Maltese: 95 % CI għal medjan
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 arbitrarju (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 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: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Accord.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' Pemetrexed Accord.
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: 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: Pemetrexed Accord 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Accord 100 mg: Kull kunjett fih 100 milligramm ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate)
English: CTC a Grade
Maltese: Twissijiet u prekawzjonijiet
English: Children and adolescents There is no relevant use of Pemetrexed Accord in the paediatric population
Maltese: Tfal u adolexxenti M'hemm ebda użu rilevanti ta' Pemetrexed Accord fil-popolazzjoni pedjatrika.
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 arbitrarju (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' tkomplija ta' manteniment b'pemetrexedflimkien 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 avanzat(Stadju IIIB) jew metastatiku (Stadju IV), ħlief meta l-istoloġija turi li fil-biċċa l-kbira ċ-ċelluli jkunu tat-tip squamous u li ma jwrew ebda progress wara 4 ċikli ta' kura primarja doppja ta' pemetrexed flimkien ma' cisplatin.
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, pruritis/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 b'mod arbitrarju ġew magħżula 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.
English: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Maltese: Dijagrammi Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u sopravivenza totali pemetrexed kontra plaċebo f'pazjenti b' NSCLC minbarra dwak fejn listoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous:
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, randomised,magħmul f'ħafna ċentri b'pemetrexed kontra docetaxel f'pazjenti b'NSCLC lokalment avvanzat jew metastatiku wara kimoterapija preċedenti, wera żminijiet medjani ta' sopravivenza ta' 8.3 xhur f'pazjenti kkurati b'pemetrexed (Popolazzjoni bl-Intenzjoni Li Jiġu Kkurati(ITT) , n = 283) u 7.9 xhur f'pazjenti kkurati b'docetaxel (ITT n = 288).
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 flawrina, b'70% sa 90% tad-doża mgħotija rkuprata mingħajr ebda modifikazzjoni fl-awrina fl-ewwel 24 siegħa minn meta tkun ngħatat id-doża.
English: Clinical efficacy
Maltese: Effikaċja klinika:
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95 % CI= 0.64-0.96).
Maltese: Mill-bidu tal-kura primarja inizjali ta' pemetrexed flimkien ma' cisplatin, l-OS medjan tal-pazjenti kien ta' 16.9 xhur għall-fergħa ta' pemetrexedu ta' 14.0 xhur għall-fergħa ta' plaċebo (hazard ratio= 0.78, 95% CI= 0.64-0.96).
English: In patients with normal renal function (creatinine clearance > 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acidat higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Maltese: F'pazjenti li jkollhom il-kliewi jaħdmu normali (tneħħija tal-krejatinina ≥ 80 ml/min), dożi għolja ta' mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs, bħal ibuprofen > 1600 mg/kuljum) kif ukoll doża għolja ta' acetylsalicylic acid (≥ 1.3 g kuljum) jistgħu jnaqqsu l-eliminazzjoni ta' pemetrexed u, b'hekk, tiżdied l-inċidenza ta' każijiet avversi ta' pemetrexed.
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) (hazard ratio = 0.60, 95% CI = 0.49-0.73,p < 0.00001).
English: Common Rash/ desquamation
Maltese: Raxx/ deskwamazzjoni
English: Median overall survival (months) (95 % CI)
Maltese: Sopravivenza globali medjana (xhur) (95 % CI)
English: Table 3 - Dose modification table for Pemetrexed Accord (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: TABELLA 3 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Accord (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Newrotossiċità Grad CTCa
English: Pemetrexed Accord 1000 mg contains approximately 108 mg sodium per vial.
Maltese: Pemetrexed Accord 1000 mg fih madwar 108 mg ta' sodium f'kull kunjett.
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' Tossiċità. *** Skont is-CTC (v 2.0; NCI 1998)ta' l-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u lalopeċja għandhom jiġu rrapportati bħala Grad 1 jew 2 biss.
English: Median time to tumour progression (months) (95 % CI)
Maltese: Log Rank p-value* Żmien medjan fil-progress tat-tumur (xhur) (95 % CI)
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Accord 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 Accord 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: Table 2 - Dose modification table for Pemetrexed Accord (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b
Maltese: TABELLA 2 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Accord (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin- Tossiċitajiet li mhumiex ematoloġiċia,b
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95 % CI = 0.51-0.81, p = 0.0002).
Maltese: L-istudju laħaq il-punt primarju tiegħu u wera titjib statistikament sinifikanti fil-PFS fil-fergħa ta' pemetrexed meta mqabbel mal-fergħa tal-plaċebo (n=472, popolazzjoni eżaminata b'mod indipendenti; medjan ta' 3.9 ta' xahar u 2.6 ta' xahar rispettivament) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 1000 mg of pemetrexed.
Maltese: Pemetrexed Accord 1000 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett tal-ħġieġ ta' Tip I b'tapp tal-lasktu bromobutyl griż b'siġill li jista' jinqala' ta' kulur blu jgħajjat li fih 1000 mg ta' pemetrexed.
English: Each vial contains approximately 108 mg sodium.
Maltese: Kull kunjett fih madwar 108 mg ta' sodium.
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Accord 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 500 mg ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
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 bl-addoċċ 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: VIAL
Maltese: KUNJETT
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'
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg
Maltese: INDIVIDWALI 100 mg
English: Infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue have been reported with an unknown frequency (e.g. acute bacterial dermo-hypodermitis, pseudocellulitis, dermatitis).
Maltese: B'frekwenza mhux magħrufa ġew irrapportati disturbi infettivi u mhux infettivi tad-dermis, l-ipodermis u/jew tattessut ta' taħt il-ġilda (eż. dermo-ipodermite batterjali akuta, psewdoċellulite, dermatite).
English: Creatinine elevation Creatinine clearance decreased**
Maltese: Tnaqqis fittneħħija talkrejatinina**
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated
Maltese: Effikaċja ta' pemetrexed ma' cisplatin vs. cisplatin f'mesoteljoma plewrali malinna
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 100ml b' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Maltese: Reazzjoni allerġika: raxx tal-ġilda/ sensazzjoni ta' tingiż jew ħruq Infezzjoni li tinkludi s-sepsis
English: To be taken into consideration by patients on a controlled sodium diet.
Maltese: Li għandu jiġi kkunsidrat minn pazjenti fuq dieta kkontrollata tas-sodium.
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Maltese: It-tabella hawn taħt tati l-frekwenza u s-severità ta' l-effetti mhux mixtieqa li ġew irrapportati f'>5% tal-265 pazjent li ntgħażlu b'mod arbitrarju biex jirċievu pemetrexed waħdu b'supplimentazzjoni ta' folic acid u vitamina
English: Fatigue (tiredness)
Maltese: Epatite (infjammazzjoni tal-fwied)
English: PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Maltese: Dijagrammi Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u Sopravivenza Totali (OS) għat-tkomplija ta' manteniment b'pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous ( kkwantifikat permezz ta' għażla b'mod arbitrarju)
English: Stomatitis/ Pharyngitis Diarrhoea without colostomy
Maltese: Dijarrea Rimettar Stomatite/ Farinġite Tqallih Anoressija
English: definition of ≥ CTC Grade 2 bleeding
Maltese: Dawn il-kriterji jissodisfaw id-definizzjoni ta' ≥CTC Grad 2 ta' fsada tal-Kriterji ta' Tossiċità
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride 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 100ml b' soluzzjoni għall-injezzjoni ta' 9mg/ml(0.9%)sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: Pemetrexed Accord should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: (BSA) mogħtija bħala infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Patients with hepatic impairment
Maltese: Disturbi gastro intestinali