FrancophonIA/ELRC3.0 huggingface dataset:
English: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3 %, > 6 cycles: 6.4 %: p=0.046).
Maltese: B'espożizzjoni itwal ġew osservati żidiet fir-reazzjonijiet avversi (kull grad).Ġiet osservata, wisq probabbli kkawżata mill-mediċina taħt studju, żieda fl-inċidenza ta' newtropinja ta' Grad 3/4 b'espożizzjoni itwal għal pemetrexed (≤6 ċikli: 3.3%, > 6 ċikli: 6.4%: p=0.046).
English: • Conjunctivitis (inflamed eye)
Maltese: • Konġuntivite (għajn infjammata)
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: Il-pazjenti għandhom jiġu sorveljati regolarment għal nekrożi tubulari akuta, tnaqqis fil-funzjoni tal-kliewi u sinjali u sintomi ta 'insipidus tad-dijabete nefroġeniku (eż. Hypernatraemia).
English: a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI
Maltese: Tossiċità Komuni (CTC) tal-Istitut Nazzjonali tal-Kanċer (CTC v2.0; NCI 1998).
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: Disturbi infettivi u mhux infettivi tad-dermis, l-ipodermis u/jew it-tessut ta' taħt il-ġilda ġew irrapportati bi frekwenza mhux magħrufa (eż. dermo-ipodermite akuta batterjali, psewdoċellulite, dermatite).
English: Hepatic impairment: 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: • Hepatitis (inflammation of the liver) • Anaphylactic shock (severe allergic reaction)
Maltese: • Xokk anafilattiku (reazzjoni allerġika severa)
English: Children and adolescents There is no relevant use of Pemetrexed Sandoz in the paediatric population.
Maltese: Tfal u adolexxenti M'hemm ebda użu rilevanti ta' Pemetrexed Sandoz fil-popolazzjoni pedjatrika.
English: Stomatitis/Pharyngitis
Maltese: .1 Proprjetajiet farmakodinamiċi
English: Nadir ANC < 500/mm3 and nadir platelets ≥ 50,000/mm3
Maltese: /mm3 u lgħadd l-iktar baxx ta' plejtlits  50,000 /mm3
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' sagħtejn madwar 30 minuta wara li tkun saret l-infużjoni ta' pemetrexed fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
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 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: Elderly: 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: Stomatitis/ Pharyngitis 14.7 1.1 17.4 1.1 Nausea
Maltese: Mukosite/Stomatite 6.8 0.8 1.7 0.0
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 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: 50% of previous dose
Maltese: 50 % tad-doża ta' qabel
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq il-website tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: 75% of previous dose (both pemetrexed and cisplatin)
Maltese: 75 % tad-doża ta' qabel (kemm pemetrexed kif ukoll cisplatin).
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 talpulmun.
English: Pemetrexed Sandoz 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Maltese: Pemetrexed Sandoz 500 mg: Kull kunjett fih 500 milligramma ta' pemetrexed (bħala pemetrexed disodium)
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: 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: Vomiting Anorexia Constipation Stomatitis/ Pharyngitis
Maltese: Dijarrea Rimettar Stomatite/ Farinġite Tqallih Anoressija
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 listudji kliniċi b'pemetrexed, ħafna drabi meta ngħata ma' sustanza ċitotossika oħra.
English: Fatigue Pain
Maltese: Popolazzjoni pedjatrika
English: Pemetrexed Sandoz 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium).
Maltese: Pemetrexed Sandoz 1000 mg: Kull kunjett fih 1000 milligramma ta' pemetrexed (bħala pemetrexed disodium)
English: • Acute renal failure
Maltese: • Irritazzjoni tal-ġilda u ħakk
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) or with glucose 50 mg/ml (5%) 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) jew bi glucose 50 mg/ml (5%) soluzzjoni għal injezzjoni (mingħajr preservattiv), u jingħata bħala infużjoni fil-vini għal 10 minuti.
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 randomised to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomised to receive cisplatin and gemcitabine.
Maltese: It-tabella hawn taħt tati l-frekwenza u s-severità tal-effetti mhux mixtieqa li huma kkunsidrati possibbilment relatati mal-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 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 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: 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 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: 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: Pemetrexed Sandoz 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Maltese: Pemetrexed Sandoz 100 mg: Kull kunjett fih 100 milligramma ta' pemetrexed (bħala pemetrexed disodium)
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: Other (N = 252)
Maltese: Oħrajn (N=252)
English: For precautions to be taken before handling or administering Pemetrexed Sandoz, see section 6.6.
Maltese: Għal Prekawzjonijiet li għandhom jittieħdu qabel ma tmiss jew tamministra Pemetrexed Sandoz, ara sezzjoni 6.6.
English: • Liver: abnormal blood tests
Maltese: • Fwied: testijiet tad-demm anormali
English: Frequency Event**
Maltese: Avveniment**
English: Pemetrexed
Maltese: Pemetrexed Placebo
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 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' pemetrexed flimkien 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: 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, mukożite, polinewropatija sensittiva, u raxx.
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Sandoz during pregnancy.
Maltese: It-tabib tiegħek jiddiskuti miegħek dwar irriskju potenzjali li tieħu Pemetrexed Sandoz waqt it-tqala.
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) tal-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: ** Which is derived from the term “renal/genitourinary other”.
Maltese: * Definizzjoni tat-termini ta' frekwenza:
English: • Allergic reaction: skin rash / burning or prickling sensation
Maltese: • Reazzjoni allerġika: raxx tal-ġilda/ sensazzjoni ta' tingiż jew ħruq
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Sandoz 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 Sandoz.
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: In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of nonsteroidal anti-inflammatory drugs (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 għoljin ta' mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs, bħal ibuprofen > 1600 mg/kuljum) kif ukoll dożi għoljin 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: • Response rate (%) (95% CI)
Maltese: Respons (n: eliġibbli għar-respons) Persentaġġ ta' respons (%) (95 % CI) marda stabbli(%)
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: The use of Pemetrexed Sandoz should be avoided during pregnancy.
Maltese: L-użu ta' Pemetrexed Sandoz għandu jiġi evitat waqt it-tqala.
English: • Fever
Maltese: •Dardir
English: 1998) definition of ≥ CTC Grade 2 bleeding.
Maltese: Dawn il-kriterji jissodisfaw id-definizzjoni ta' ≥CTC Grad 2 ta' fsada tal-Kriterji ta'
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: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma
Maltese: Effikaċja ta' pemetrexed ma' cisplatin vs. cisplatin f'mesoteljoma plewrali malinna
English: NSCLC, first-line treatment
Maltese: NSCLC, l-ewwel linja ta' kura:
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 Sandoz flimkien ma' cisplatin fis-sottogruppi ta' istoloġija.
English: • Interstitial pneumonitis (scarring of the air sacs of the lung)
Maltese: • Pulmonite interstizjali (il-boroż tal-arja ġewwa 'l pulmun irabbu qoxra)
English: Pemetrexed Sandoz 100 mg contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Maltese: Pemetrexed Sandoz 100 mg fih inqas minn 1 mmol sodium (23 mg) għal kull kunjett, jiġifieri hija essenzjalment mingħajr sodium.
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: Ebewe Pharma GmbH Nfg.
Maltese: METODU TA' KIF GĦANDU JINGĦATA
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: 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: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Pemetrexed Sandoz 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Sandoz 500 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Sandoz 1000 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni pemetrexed
English: After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjonikull kunjett fih 25 mg/ml ta' pemetrexed.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
Maltese: INDIVIDWALI 500 mg
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 b'mod arbitrarju 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: Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Maltese: Domaniewska 50C 02-672 Warszawa Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
English: • Oedema (excess fluid in body tissue, causing swelling)
Maltese: • Edima (fluwidu żejjed fit-tessuti tal-ġisem li jikkawża nefħa).
English: Limited clinical data from a separate randomised, 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).
English: Large cell (N = 153)
Maltese: Ċellula kbira (N=153)