FrancophonIA/ELRC3.0 huggingface dataset:
English: Pemetrexed Pfizer 1,000mg vial:
Maltese: Pemetrexed Pfizer kunjett ta' 1,000 mg:
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, insuffiċjenza renali u renali/ġenitoawrinarji-oħrajn.
English: Pemetrexed undergoes limited hepatic metabolism.
Maltese: Pemetrexed ikollu metaboliżmu limitat fil-fwied.
English: Common Dyspepsia
Maltese: Komuni Dispepsja
English: **In the pemetrexed /cisplatin arm, randomised and treated (N=225) and fully supplemented (N=167).
Maltese: **Fil-fergħa ta' pemetrexed /cisplatin, każwali u trattati (N=225) u mogħtija suppliment tul it-terapija kollha (N=167).
English: Superio rity p
Maltese: Superjo rità
English: 50% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: 100% tad-doża ta' qabel Kriterji Komuni ta' Tossiċità tal-Istitut tal-Kanċer (CTC v2.0; NCI 1998)
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' każijiet avversi meta mqabbla ma' pazjenti li għandhom inqas minn 65 sena.
English: Squamous cell (N = 473)
Maltese: Ċellula tat-tip skwamuża (N = 473)
English: Each pack contains one glass vial of 100 mg, 500 mg or 1,000 mg pemetrexed.
Maltese: Kull pakkett fih kunjett wieħed tal-ħġieġ ta' 100 mg, 500 mg jew 1,000 mg pemetrexed ).
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 każwali ġew magħżula biex jirċievu pemetrexed jinkludu: reazzjoni allerġika/sensittività eċċessiva, eritema multiforme, arritmija supraventrikulari u emboliżmu pulmomarju.
English: Clinically relevant toxicities with respect to gender were similar to the overall population in patients receiving pemetrexed plus cisplatin.
Maltese: Tossiċitajiet klinikament rilevanti skond is-sess, kienu simili għall-popolazzjoni totali f'pazjenti li rċevew pemetrexed flimkien ma' cisplatin.
English: System organ class Frequency Event*
Maltese: Sistema tal-klassifika tal-organi
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Pfizer.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' Pemetrexed Pfizer.
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
Maltese: 426 pazjent bil-kanċer li kellhom diversi tumuri solidi.
English: Pemetrexed Pfizer must only be further diluted with 5% glucose solution, without preservative.
Maltese: Pemetrexed Pfizer irid jerġa' jiġi dilwit biss b'soluzzjoni ta' 5% glukożju, mingħajr preservattiv.
English: No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified.
Maltese: Ma kienet identifikata l-ebda relazzjoni bejn l-AST (SGOT), l-ALT (SGPT), jew it-total ta' bilirubina u l-farmakokinetika ta' pemetrexed.
English: Oral folic acid and intramuscular vitamin B12 supplementation do not affect the pharmacokinetics of pemetrexed.
Maltese: B12 minn ġol-muskoli ma jinfluwenzawx il-farmakokinetika ta' pemetrexed.
English: You will also receive an injection of vitamin B12 (1,000 micrograms) in the week before administration of Pemetrexed Pfizer and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Pfizer treatment).
Maltese: B12 (1,000 mikrogramma) fil-ġimgħa ta' qabel li tingħata Pemetrexed Pfizer u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura bi Pemetrexed Pfizer).
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjoni (ara sezzjoni 6.6) kull kunjett fih 25 mg/ml ta' pemetrexed.
English: Haemoglobin decreased
Maltese: Tnaqqis fl-emoglobina
English: A multi-centre, 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 multiċentriku, każwali u double-blind bi plaċebo bħala kontroll ta' Fażi 3, (JMEN), qabbel l-effikaċja u s-sigurtà ta' trattament ta' manteniment bi pemetrexed flimkien mal-aħjar kura ta' sostenn (AKS) (n = 441) ma' dik ta' plaċebo flimkien ma' AKS (n = 222) f'pazjenti b'kanċer tal-pulmun mhux b'ċelluli żgħar (non-small cell lung cancer, NSCLC) lokalment avvanzat (Stadju IIIB) jew metastatiku (Stadju IV) u li ma għamilx progress wara 4 ċikli ta' kura preferenzjali doppja (doublet) li kien fiha cisplatin jew carboplatin flimkien ma' gemcitabine, paclitaxel jew docetaxel.
English: The recommended dose of pemetrexed 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 hi ta' 500 mg/m2 tal-erja tas-superfiċje tal-ġisem (body surface area, BSA) mogħtija bħala infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Other (N = 252)
Maltese: Oħrajn (N = 252)
English: Dose modification table for pemetrexed (as a single agent or in combination) and cisplatin - Non-haematologic toxicities a, b
Maltese: Tabella għall-modifikazzjoni ta' pemetrexed (bħala terapija b'sustanza unika jew ikkombinata) u cisplatin - Tossiċitajiet mhux ematoloġiċi a, b
English: EMPHACIS, a multi-centre, 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 każwali, multiċentrali, ta' fażi 3, single-blind, 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: The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leucopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, and stomatitis.
Maltese: L-aktar effetti mhux mixtieqa li ġew irrapportati b'mod komuni u li għandhom x'jaqsmu ma' pemetrexed kemm jekk jintuża bħala monoterapija u kemm jekk jintuża flimkien ma' prodotti mediċinali oħra huma t-tnaqqis fil-funzjoni tal-mudullun li jidher bħala anemija, newtropenja, lewkopenija, tromboċitopenja; u tossiċitajiet gastrointestinali li jidhru bħala anoreksja, dardir, rimettar, dijarea, stitikezza, farinġite, mukożitè u stomatite.
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: 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 bi pemetrexed kien konsistenti internament fis-sottogruppi varji (inklużi stadju tal-marda, rispons fil-bidu, ECOG PS, stat ta' tipjip, sess, istoloġija u età) u simili għal dak osservat fl-analiżi mhux aġġustati ta' OS u PFS.
English: There were no clinically relevant differences observed for the safety profile of pemetrexed within the histology subgroups.
Maltese: Ma ġewx osservati differenzi klinikament relevanti fil-profil ta' sigurtà ta' pemetrexed fis-sottogruppi istoloġiċi.
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Pemetrexed Pfizer 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Pfizer 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Pfizer 1,000 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: The infusion will last approximately 10 minutes.
Maltese: L-infużjoni ddum madwar 10 minuti.
English: Statistically significant differences in pulmonary function tests were also observed.
Maltese: Differenzi statistikament sinifikanti kienu osservati wkoll fit-testijiet tal-funzjoni tal-pulmun.
English: Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia, mucositis, sensory polyneuropathy, and rash.
Maltese: Sintomi ta' doża eċċessiva li ġew irrapportati jinkludu: newtropenja, anemija, tromboċitopenja, mukożitè, polinewropatija sensittiva, u raxx.
English: However, patients with hepatic impairment, such as bilirubin > 1.5times 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 darbiet il-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: 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 (HR) 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.
English: 50% of previous dose (both pemetrexed and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: 50% tad-doża ta' qabel (kemm pemetrexed u cisplatin) Dawn il-kriterji jissodisfaw id-definizzjoni ta' ≥CTC Grad 2 ta' fsada tal-Kriterji ta' Tossiċità Komuni (CTC) ta' l-Istitut Nazzjonali tal-Kanċer (CTC v2.0; NCI 1998).
English: Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and toxic epidermal necrolysis
Maltese: Kundizzjonijiet bullożi (mard tal-ġilda b'ħafna nfafet)- li jinkludu s-sindromu ta' Stevens-Johnson u Nekrożi epidermali tossika
English: a Statistically significant for non-inferiority, with the entire confidence interval for HR well below the 1.17645 non-inferiority margin (p < 0.001).
Maltese: Statistikament sinjifikanti biex ma tkunx inferjuri, bl-intervall ta' kunfidenza għal HR kollu kemm hu ħafna taħt il-marġni ta' 1.17645 li turi li mhemmx inferjorità (p < 0.001).
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: Other medicines and Pemetrexed Pfizer
Maltese: Mediċini oħra u Pemetrexed Pfizer
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: 50% of previous dose
Maltese: 50% tad-doża ta' qabel
English: Renal Disorders Common Renal disorders****
Maltese: Disturbi fil kliewi****
English: Patients should be regularly monitored for acute tubular necrosis, decreased renal function and signs and symptoms of nephrogenic diabetes insipidus (e.g. hypernatraemia).
Maltese: Ilpazjenti għandhom jiġu mmonitorjati regolarment għal nekrożi tubulari akuta, funzjoni renali indebolita u sinjali u sintomi ta' inspidus tad-dijabete nefroġenika (eż. ipernatremija).
English: Creatinine clearance should be ≥ 45 ml/min.
Maltese: It-tneħħija tal-kreatinina għandha tkun ta' ≥ 45 ml/min.
English: Consistent with other pemetrexed studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Maltese: Konsistenti ma' studji oħra ta' pemetrexed, f'JMEN ġiet osservata differenza fl-effikaċja skont listoloġija tal-NSCLC.
English: Liver: abnormal blood tests
Maltese: Kliewi: testijiet tad-demm anormali
English: Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, and acetylsalicylic acid (>1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Maltese: Pazjenti b'insuffiċjenza renali minn ħafifa għal moderata (tneħħija ta' kreatinina bejn 45 u 79 ml/min) għandhom jevitaw li jieħdu mediċini antinfjammatorji li mhumiex sterojdi (non-steroidal antiinflammatory drugs, 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: Pack of 1 vial.
Maltese: Pakkett b'kunjett wieħed.
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 punt aħħari 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: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent-to-treat; N = total population size.
Maltese: ITT = intenzjoni li tittratta; N = daqs tal-popolazzjoni kollha.
English: Grade toxicity
Maltese: Grad ta tossiċità
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 mgħotija rkuprata mingħajr ebda modifikazzjoni fl-awrina fl-ewwel 24 siegħa minn meta tkun ngħatat id-doża.
English: Pemetrexed Pfizer 500mg vial:
Maltese: Pemetrexed Pfizer kunjett ta' 500 mg:
English: Median time to tumour progression (months) (95% CI)
Maltese: Żmien medjan fil-progress tat-tumur (xhur) (95% CI)
English: A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed.
Maltese: Total ta' 169 pazjent (47.1 %) spiċċaw ≥ 6 ċikli ta' kura ta' manteniment b'pemetrexed, li jirrappreżentaw għallinqas 10 ċikli sħaħ ta' pemetrexed.
English: Rarely seen events include Stevens-Johnson syndrome and toxic epidermal necrolysis.
Maltese: Każijiet li dehru b'mod rari jinkludu s-sindromu ta' Stevens-Johnson u nekroliżi epidermali tossika.
English: Stomatitis
Maltese: Pożoloġija
English: Therefore, all patients treated with pemetrexed must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatment-related toxicity (see section 4.2).
Maltese: B12 bħala miżura profilattika biex tonqos it-tossiċità relatata mal-kura (ara sezzjoni 4.2).
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 tal-istoloġija.
English: A multi-centre, 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 [ITT] population N = 283) and 7.9 months for patients treated with docetaxel (ITT N = 288).
Maltese: Studju multiċentriku, każwali ta' Fażi 3, bit-tikketta tingħaraf, 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: Common SGPT (ALT) elevation 7.9 SGOT (AST) elevation 6.8
Maltese: Żieda fl-ALT (SGPT) 6.5 0.1 2.2 Żieda fl-AST (SGOT) 5.9 0.0
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Store the 100 mg vial below 30°C.
Maltese: Pemetrexed Pfizer 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Aħżen Il-kunjett ta' 100 mg f'temperatura taħt 30°C.
English: No statistically significant differences in any other individual Grade 3/4/5 adverse reactions were seen with longer exposure.
Maltese: Ma dehru ebda differenzi statistikament sinifikanti fir-reazzjonijiet individwali avversi oħra ta' Grad 3/4/5 b'espożizzjonijiet itwal.
English: Overall response rate** 41.3% (95% CI)
Maltese: Ir-rata ta' rispons globali** (95% CI)
English: A multi-centre, 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 każwali, double-blind, multiċentriku, bi plaċebo bħala kontroll ta' Fażi 3 (PARAMOUNT), qabbel l-effikaċja u s-sigurtà ta' kura ta' tkomplija ta' manteniment bi pemetrexed flimkien ma' BSC (N=359) ma' dik ta' plaċebo flimkien ma' BSC (N=180) f'pazjenti li għandhom kanċer tal-pulmun 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 skwamużi u li ma wrew ebda progress wara 4 ċikli ta' kura primarja doppja ta' pemetrexed flimkien ma' cisplatin.
English: Icepharma hf. Sími: +354 540 8000
Maltese: Sími: +354 540 8000
English: Adjusted hazard ratio
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
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, lOS medjan tal-pazjenti kien ta' 16.9 xhur għall-fergħa ta' pemetrexed u ta' 14.0 xhur għall-fergħa ta' plaċebo (hazard ratio= 0.78, 95% CI= 0.64-0.96).
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 ta' Cockcroft & Gault jew Metodu tat-tneħħija mis-serum ta' Tc99m-DPTA biex tiġi kkalkulata r-rata ta' filtrazzjoni glomerulari) Pemetrexed jiġi eliminat prinċipalment bla ebda modifikazzjoni permezz ta' tneħħija mill-kliewi.
English: Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident, and transient ischaemic attack, have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Maltese: Każijiet ċerebrovaskulari u kardjovaskulari serji, li jinkludu infart mijokardijaku, anġina pectoris, inċident ċerebrovaskulari u attakk iskemiku tranżitorju ġew irrapportati mhux frekwentement matul l-istudji kliniċi b'pemetrexed, ħafna drabi meta ngħata ma' sustanza ċitotossika oħra.
English: Haemolytic anaemia (anaemia due to destruction of red blood cells) Hepatitis (inflammation of the liver)
Maltese: Anemija emolitika (anemija minħabba li jinqerdu ċ-ċelluli ħomor tad-demm) Epatite (infjammazzjoni tal-fwied)
English: How to use Pemetrexed Pfizer
Maltese: X'fih Pemetrexed Pfizer
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study medicinal product that have been reported in > 5% of 839 patients with NSCLC who were randomised to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomised to receive cisplatin and gemcitabine.
Maltese: It-tabella hawn taħt tagħti l-frekwenza u s-severità ta' l-effetti mhux mixtieqa li huma kkunsidrati possibbilment relatati mal-prodott mediċinali 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: 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 =
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Pfizer has finished.
Maltese: Cisplatin ukoll jingħata b'infużjoni f'waħda mill-vini tiegħek, u jingħata madwar 30 minuta wara li tkun spiċċat l-infużjoni ta' Pemetrexed Pfizer.
English: Creatinine elevation Creatinine clearance decreased**
Maltese: Tnaqqis fit-tneħħija ta' kreatinina**