FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies have shown that pemetrexed behaves as a multi-targeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Maltese: Studji in vitro wrew li pemetrexed jaġġixxi bħala antifolat b'iżjed minn objettiv wieħed billi jinibixxi thymidylate synthase (TS), dihydrofolate reductase (DHFR), u glycinamide ribonucleotide formyltransferase (GARFT), li huma enzimi dipendenti fuq il-folat u huma kruċjali għall-bijosintesi de novo tan-nukleotidi thymidine u purine.Pemetrexed jittieħed ġewwa ċ-ċelluli permezz taż-zewġ sistemi tat-trasport, it-trasportatur ta' folat ridott u proteina fil-membrana li jeħel magħha l-folat.
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion 10 ml vial (transparent type I glass) with bromobutyl rubber stopper and aluminium cap with tear off part made of polypropylene (embossed with sign “FLIP OFF”): containing 100 mg pemetrexed.
Maltese: Pemetrexed Krka 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett ta' 10 ml (trasparenti tal-ħġieġ ta' Tip I) b'tapp tal-lasktu bromobutyl u għatu tal-aluminju b'parti li tiċċarrat magħmula minn polypropylene (b'sinjal imqabbeż ta' “FLIP OFF”) li fih 100 mg.
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion 50 ml vial (transparent type I glass) with bromobutyl rubber stopper and aluminium cap with tear off part made of polypropylene (embossed with sign “FLIP OFF”): containing 500 mg pemetrexed.
Maltese: Pemetrexed Krka 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett ta' 50 ml (trasparenti tal-ħġieġ ta' Tip I) b'tapp tal-lasktu bromobutyl u għatu tal-aluminju b'parti li tiċċarrat magħmula minn polypropylene (b'sinjal imqabbeż ta' “FLIP OFF”) li fih 500 mg.
English: Grade 3
Maltese: °C u 8
English: 50% of previous dose (both Pemetrexed Krka and cisplatin)
Maltese: 50 % tad-doża ta' qabel (kemm Pemetrexed Krka kif ukoll cisplatin)
English: Pemetrexed Krka 500 mg contains 54 mg sodium (main component of cooking/table salt) per vial.
Maltese: Pemetrexed Krka 500 mg fih madwar 54 mg ta' sodium (komponent ewlieni ta' melħ għat-tisjir/talmejda) f'kull kunjett.
English: Chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at 2°C to 8°C (and 25°C).
Maltese: L-istabbilità kimika u fiżika ta' waqt l-użu, tas-soluzzjonijiet rikostitwiti u ta' infużjoni ta' pemetrexed ġiet ippruvata għal 24 siegħa f'temperatura ta' 2°C sa 8°C (u 25°C).
English: May 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Mejju 2018
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: 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: Common Rash/desquamation
Maltese: Raxx/ deskwamazzjoni
English: Other medicines and Pemetrexed Krka
Maltese: Mediċini oħra u Pemetrexed Krka
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 multiċentrali ta' Fażi 3, open-label, randomised, 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: 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: Pemetrexed Krka (pemetrexed) is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Maltese: Pemetrexed Krka (pemetrexed) huwa sustanza antifolatika, antikanċeroġenika u għandu iżjed minn obbjettiv wieħed.
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion This medicinal product contains 54 mg sodium per vial, equivalent to 2.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Pemetrexed Krka 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċinali fih 54 mg sodium f'kull kunjett ekwivalenti għal 2.7% tat-teħid massimu ta' kuljum mis-2 g ta' sodium rakkomandat mill-WHO għal adult.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Krka and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Krka treatment).
Maltese: B12 (1000 microgramma) fil-ġimgħa ta' qabel li tingħata Pemetrexed Krka u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura b'Pemetrexed Krka).
English: Table 3 - Dose modification table for Pemetrexed Krka (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: TABELLA 3 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Krka (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Newrotossiċità Grad CTC
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 multiċentrali ta' Fażi 3 kkontrollat bil-plaċebo, open-label, 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: Excipient with known effect Each vial contains approximately 11 mg (0.48 mmol) sodium.
Maltese: Eċċipjent b'effett magħruf Kull kunjett fih madwar 11 mg (0.48 mmol) ta' sodium.
English: Side effects with Pemetrexed Krka may include:
Maltese: Effetti sekondarji ta' Pemetrexed Krka jistgħu jinkludu:
English: Pemetrexed Krka 500 mg: Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Krka 500 mg: Kull kunjett fih 500 mg ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: However, patients with hepatic impairment, such as bilirubin > 1.5-times the upper limit of normal and/or aminotransferase > 3.0-times the upper limit of normal (hepatic metastases absent) or > 5.0-times the upper limit of normal (hepatic metastases present), have not been specifically studied.
Maltese: Madankollu, ma ġewx studjati speċifikament pazjenti b'indeboliment tal-fwied, bħal każijiet ta' bilirubina > 1.5 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: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
Maltese: * Irreferi għal verżjoni 2 tas-CTC tal-Istitut Nazzjonali tal-Kanċer għal kull grad ta' tossiċità.
English: Pemetrexed Krka 100 mg: Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Krka 100 mg: Kull kunjett fih 100 mg ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate)
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 sinifikanti biex ma tkunx inferjuri, bl-intervall ta' kunfidenza għal HR kollu kemm hu ħafna taħt il-marġni ta' 1.17645 li turi li m'hemmx inferjorità (p <.001).
English: Common (may affect up to 1 in 10 people) - Allergic reaction: skin rash / burning or prickling sensation - Infection including sepsis - Fever - Dehydration - Kidney failure - Irritation of the skin and itching - Chest pain - Muscle weakness - Conjunctivitis (inflamed eye) - Upset stomach - Pain in the abdomen - Taste change - Liver: abnormal blood tests - Watery eyes - Increased skin pigmentation
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) - Reazzjoni allerġika: raxx tal-ġilda/ sensazzjoni ta' tingiż jew ħruq - Infezzjoni li tinkludi s-sepsis - Deni - Deidrazzjoni - Insuffiċjenza tal-kliewi - Irritazzjoni tal-ġilda u ħakk - Uġigħ fis-sider - Dgħufija fil-muskoli - Konġuntivite (għajn infjammata) - Taqlib fl-istonku - Uġigħ fl-addome - Tibdil fit-togħma - Fwied: testijiet tad-demm anormali - Għajnejn idemmgħu - Żieda fil-pigmentazzjoni tal-ġilda
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 multiċentrali ta' Fażi 3 kkontrollat bil-plaċebo, double-blind, u b'mod arbitrarju (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' tkomplija ta' manteniment b' pemetrexed flimkien ma' BSC (N=359) ma' dik ta' plaċebo flimkien ma' BSC (N=180) f'pazjenti li għandhom kanċer tal-pulmun mhux b'ċelluli żgħar u li jkun lokalment avanzat(Stadju IIIB) jew metastatiku (Stadju IV), ħlief meta listoloġija 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: 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 Krka 500 mg powder for concentrate pemetrexed
Maltese: Pemetrexed Krka 500 mg trab għal konċentrat 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: **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Maltese: ** Irreferi għas-CTC (v 2.0; NCI 1998) tal-Istitut Nazzjonali tal-Kanċer għal kull Grad ta' Tossiċità.
English: These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥ CTC Grade 2 bleeding.
Maltese: Kriterji ta' Tossiċità Komuni ta' l-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998) Minbarra n-newrotossiċità
English: Stomatitis/Pharyngitis
Maltese: 5. PROPRJETAJIET FARMAKOLOĠIĊI
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: Table 1 - Dose modification table for Pemetrexed Krka (as single agent or in combination) and cisplatin - Haematologic toxicities
Maltese: TABELLA 1 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Krka (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Tossiċitajiet ematoloġiċi
English: Pemetrexed Krka 100 mg powder for concentrate pemetrexed
Maltese: Pemetrexed Krka 100 mg trab għal konċentrat pemetrexed
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Maltese: ITT = intenzjoni li tikkura; N = daqs talpopolazzjoni totali.
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' krejatinina bejn 45 u 79 ml/min) għandhom jevitaw li jieħdu mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs), bħal ibuprofen, u acetylsalicylic acid (> 1.3 g kuljum) minn jumejn qabel, dakinhar, u sa jumejn wara l għoti ta' pemetrexed (ara sezzjoni 4.5).
English: 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 hazard ratio (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, proporzon ta' riskju (HR) aġġustat = 0.78; 95% CI=0.61-1.00, p = 0.
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Krka.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' Pemetrexed Krka.
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' pemetrexed u ta' 14.0 xhur għall-fergħa ta' plaċebo (hazard ratio= 0.78, 95% CI= 0.64-0.96).
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: Avvenimenti serji ċerebrovaskulari u kardjovaskulari, li jinkludu infart mijokardijaku angina 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: 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: 6% (95% CI=27.3-33.9) għalpemetrexed flimkien ma'cisplatin kontra28.2% (95% CI=25.0-31.4)għal gemcitabineflimkien ma'cisplatin.
English: Median overall survival (months) (95% CI) Log rank p-value*
Maltese: Log Rank p-value* Żmien medjan fil-progress tat-tumur (xhur) (95 % CI)
English: pemetrexed/ Cisplatin (N=168)
Maltese: Frekwenza Avveniment* Pemetrexed/cisplatin N=168
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.
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: Clinically relevant CTC toxicity of any grade that was reported in ≥1% and ≤5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Maltese: Tossiċità CTC klinikament rilevanti ta' kwalunkwe grad li ġiet irrapportata f' ≥ 1% u  5% (komuni) tal-pazjenti li 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: Clinically relevant CTC toxicities that were reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' ≥ 1% u ≤ 5% (komuni) tal-pazjenti li ntgħażlu bl-addoċċ biex jirċievu cisplatin u pemetrexed jinkludu: insuffiċjenza renali, infezzjoni, deni, newtropenja bid-deni, żieda fl-AST,ALT u GGT, urtikarja, u uġigħ fis-sider.
English: 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 acid at higher doses (≥ 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 dożi 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: - Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) - Hepatitis (inflammation of the liver) - Anaphylactic shock (severe allergic reaction)
Maltese: Johnson u Nekrożi epidermali tossika - Anemija emolitika kkawżata mis-sistema immunitarja tiegħek stess (jinqerdu ċ-ċelluli ħomor tad-demm minħabba l-antikorpi) - Epatite (infjammazzjoni tal-fwied) - Xokk anafilattiku (reazzjoni allerġika severa)
English: Table 2 - Dose modification table for Pemetrexed Krka (as single agent or in combination) and cisplatin - Non-haematologic toxicities a, b
Maltese: TABELLA 2 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Krka (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin- Tossiċitajiet li mhumiex ematoloġiċi a,b
English: Uncommon (may affect up to 1 in 100 people) - Acute renal failure - Fast heart rate - Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed/radiation therapy - Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) - Interstitial pneumonitis (scarring of the air sacs of the lung) - Oedema (excess fluid in body tissue, causing swelling) - Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer therapy - Pancytopenia- combined low counts of white cells, red cells and platelets - Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna) - Jerġa' jidher l-effett tar-radjazzjoni (raxx tal-ġilda bħal meta tinħaraq b'mod sever minħabba tixmix żejjed), li jista' jseħħ fuq ġilda li tkun ġiet esposta qabel għar-radjoterapija, minn ġranet sa snin wara li tkun saret ir-radjazzjoni - Kundizzjonijiet bullożi (mard tal-ġilda b'ħafna nfafet)- li jinkludu s-sindromu ta' Stevens
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Pemetrexed Krka 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Irrikostitwixxi kunjetti ta' 500 mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Limited clinical data from a separate randomized, Phase 3, controlled trial, suggest that efficacy data (overall survival, progression-free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (N=41) and patients who did not receive previous docetaxel treatment (N=540).
Maltese: Informazzjoni klinika limitata, minn studju separat, kkontrollat u, randomised ta' Fażi 3, tissuġġerixxi li l-informazzjoni dwar l-effikaċja (sopravivenza totali, sopravivenza mingħajr progressjoni) għal pemetrexed huma simili bejn il-pazjenti li kienu ġew ikkurati qabel b'docetaxel(N=41) u pazjenti li ma rċevewx kura b'docetaxel qabel (N=540).