FrancophonIA/ELRC3.0 huggingface dataset:
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: The other ingredients are mannitol, hydrochloric acid concentrated and trometamol.
Maltese: Is-sustanzi l-oħra huma mannitol, hydrochloric acid ikkonċentrat u trometamol.
English: 75 % of previous dose 75 % of previous dose
Maltese: 75 % tad-doża ta' qabel
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: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Maltese: Id-data tal-PFS ġew parzjalment ikkonfermati minn stħarriġ indipendenti (400/1725 pazjent ġew magħżula b'mod arbitrarju għall- istħarriġ).
English: Pemetrexed Fresenius Kabi 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed diacid).
Maltese: Pemetrexed Fresenius Kabi 500 mg: Kull kunjett fih 500 milligramm ta' pemetrexed (bħala pemetrexed diacid)
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 (15.2 % konta 1.9 %, rispettivament).
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 bi 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: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Fresenius Kabi.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara laħħar doża ta' Pemetrexed Fresenius Kabi.
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 tannormal u/jew aminotransferase > 3.0 darbiet il-limitu massimu tan-normal (mingħajr metastażi filfwied) jew > 5.0 darbiet il-limitu massimu tan-normal (b'metastażi fil-fwied).
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.
English: Creatinine clearance decreased**
Maltese: Tnaqqis fittneħħija talkrejatinina**
English: Detailed information on this product is available on the website of European Medicinal Agency http://www.ema/europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini http://www.ema/europa.eu
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 għall- kura inizjali ta' pemetrexed flimkien ma' cisplatin.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Fresenius Kabi and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Fresenius Kabi treatment).
Maltese: B12 (1000 microgramma) fil-ġimgħa ta' qabel li tingħata Pemetrexed Fresenius kabi u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura b'Pemetrexed Fresenius Kabi).
English: Pemetrexed Fresenius Kabi in combination with cisplatin The recommended dose of Pemetrexed Fresenius Kabi is 500 mg/m of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: Pemetrexed Fresenius Kabi flimkien ma' cisplatin Id-doża rakkomandata ta' Pemetrexed Fresenius Kabi hi ta' 500 mg/m ta' l-erja tas-superfiċje tal ġisem (BSA) mogħtija bħala infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Table 3 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin-Neurotoxicity
Maltese: TABELLA 3 - Tabella għall-modifikazzjoni fid-doża ta' pemetrexed (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Newrotossiċità
English: 50 % of previous dose 100 % of previous dose a
Maltese: 100 % tad-doża ta' qabel a
English: Grades toxicity
Maltese: Grad ta' tossiċità
English: Pemetrexed has a steady-state volume of distribution of 9 l/m2.
Maltese: Pemetrexed għandu volum taddistribuzzjoni fiss ta'9 l/m
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: Concomitant use contraindicated Yellow fever vaccine: risk of fatal generalised vaccinale disease (see section 4.3).
Maltese: Il-vaċċin tal-yellow fever: riskju ta' mard vaċċinali ġeneralizzat li jwassal għall-mewt (ara sezzjoni 4.3).
English: Read the package leaflet before use.
Maltese: Kull pakkett ta' fih kunjett wieħed.
English: How to store Pemetrexed Fresenius Kabi
Maltese: Mediċini oħra u Pemetrexid Fresenius Kabi
English: Side effects with Pemetrexed Fresenius Kabi may include:
Maltese: Effetti sekondarji ta' Pemetrexed Fresenius Kabi jistgħu jinkludu:
English: ** In the pemetrexed /cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Maltese: ** Fil-fergħa ta' pemetrexed /cisplatin, ntgħażlu bl-addoċċ u kkurati (N = 225) u mogħtija suppliment tul it-terapija kollha (N = 167)
English: For infusion solution of pemetrexed, chemical and physical in-use stability was demonstrated for 21 days at refrigerated temperature and 7 days at room temperature.
Maltese: Għall-infużjoni Soluzzjoni ta 'pemetrexed, kimika u fiżika waqt l-użu ntweriet għal 21 jum f'temperatura refriġerati u 7 ijiem f'temperatura tal-kamra.
English: Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion Pemetrexed Fresenius Kabi 500 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Informazzjoni għall-utent Pemetrexid Fresenius Kabi 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Pemetrexid Fresenius Kabi 500 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni pemetrexed
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: BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: BSA mogħtija b'infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
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: 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 blIntenzjoni Li Jiġu Kkurati(ITT), n = 283) u 7.9 xhur f'pazjenti kkurati b'docetaxel (ITT n = 288).
English: Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section 4.2).
Maltese: Dexamethasone (jew l-ekwivalenti) mogħti qabel il-kura jista' jnaqqas l-inċidenza u lgravità ta' reazzjonijiet fil-ġilda (ara sezzjoni 4.2).
English: Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory medicinal product (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: 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: Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (excess fluid in body tissue, causing swelling).
Maltese: Pulmonite interstizjali (il-boroż ta' l-arja ġewwa 'l pulmun irabbu qoxra) Edima (fluwidu żejjed fit-tessuti tal-ġisem li jikkawża nefħa).
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: 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: 75 % of previous dose (both pemetrexed and cisplatin)
Maltese: 75 % tad-doża ta' qabel (kemm pemetrexed kif ukoll cisplatin )
English: Common Neuropathysensory
Maltese: Minbarra n-newrotossiċità
English: Median time to tumour progression (months) (95% CI)
Maltese: Żmien medjan fil-progress tat-tumur (xhur) (95 % CI)
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 fissottogruppi istoloġiċi.
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 tal- pulmun mhux b'ċelluli żgħar- popolazzjoni ITT u sottogruppi istoloġiċi.
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
Maltese: Il-medjan tal-OS tal-popolazzjoni in ġenerali (n= 663) kien ta' 13.4 xhur għallfergħa ta' pemetrexed u ta' 10.6 xhur għall-fergħa tal-plaċebo, hazard ratio= 0.79 (95% CI = 0.65
English: Large cell (N=153)
Maltese: Ċellula kbira (N=153)
English: In patients with normal renal function (creatinine clearance > 80 ml/min), high doses of non-steroidal anti-inflammatory medicinal product (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acid at 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: NeuropathySensory
Maltese: Il-Ġermanja
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività għas-sustanza attiva jew għal kwalunkwe eċċipjent elenkati fit-taqsima 6.1.
English: 50 % of previous dose (both pemetrexed and cisplatin)
Maltese: 50 % tad-doża ta' qabel (kemm pemetrexed kif ukoll cisplatin)
English: Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin-Non-haematologic toxicities a, b
Maltese: TABELLA 2 - Tabella għall-modifikazzjoni fid-doża għal pemetrexed (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin- Tossiċitajiet li mhumiex ematoloġiċi a,b
English: Stomatitis/
Maltese: Dijarrea
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 (as single agent or in combination) and cisplatin- Haematologic toxicities
Maltese: TABELLA 1 - Tabella għall-modifikazzjoni fid-doża ta' pemetrexed (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Tossiċitajiet ematoloġiċi
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: *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 fittogħma u l- alopeċja għandhom jiġu rrapportati bħala Grad 1 jew 2 biss.
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: 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 (finnuqqas ta' newtropinja), mard fis-superfiċji tal-għajn (inkluża l-konġuntivite), żieda fit-tixrid ta' dmugħ, sturdament u newropatija motorja.
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomised and treated patients
Maltese: * Valuri P < 0.05 meta tqabbel pemetrexed/cisplatin ma' gemcitabine/cisplatin, permezz talFisher
English: When prepared as directed, reconstituted and infusion solutions of Pemetrexed Fresenius Kabi contain no antimicrobial preservatives.
Maltese: Meta ppreparati kif suppost, is-soluzzjonijiet rikostitwiti u ta' infużjoni ta' Pemetrexed Fresenius Kabi ma jkun fihom ebda preservattiv antimikrobiku.
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: MARKETING AUTHORISATION NUMBER EU/1/16/1115/002
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1115/002
English: After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjoni, kull kunjett fih 25 mg/ml ta' pemetrexed.
English: Reconstitute 100-mg vials with 4.2 ml of 5% glucose intravenous infusion resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kunjetti ta' 100 mg b'4.2 ml, ta' infużjoni intravenuża ta' 5 % glukożju li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Rash Alopecia
Maltese: Prurite Alopeċja
English: Median overall survival (months) (95% CI)
Maltese: Sopravivenza globali medjana (xhur) (95 % CI)
English: Reconstitute 500-mg vials with 20 ml of 5% glucose intravenous infusion resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kunjetti ta' 500 mg b'20 ml ta' infużjoni intravenuża ta' 5% glukożju li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
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 838 mg/m infused over a 10-minute period.
Maltese: Wara l-għoti ta' pemetrexed bħala mediċina weħidha, il-proprjetajiet farmakokinetiċi ta' pemetrexed ġew evalwati f'dożi li jvarjaw bejn 0.2 sa 838 mg/m infużi fuq perijodu ta' għaxar minuti f'426 pazjent bil-kanċer li kellhom diversi tumuri solidi.
English: MARKETING AUTHORISATION NUMBER EU/1/16/1115/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1115/001
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) talpazjenti 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.