FrancophonIA/ELRC3.0 huggingface dataset:
English: 75 % of previous dose (both ALIMTA and cisplatin)
Maltese: 75 % tad-doża ta' qabel (kemm ALIMTA kif ukoll cisplatin)
English: Of the randomised patients, 44.9% had a complete/partial response and 51.9% had a response of stable disease to ALIMTA 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' ALIMTA flimkien ma' cisplatin.
English: LIST OF EXCIPIENTS Mannitol, hydrochloric acid, sodium hydroxide (see package leaflet for further information).
Maltese: TA' EĊĊIPJENTI Mannitol, hydrochloric acid, sodium hydroxide (għal aktar informazzjoni ara l-fuljett ta' tagħrif).
English: In vitro studies have shown that pemetrexed behaves as a multitargeted 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 jinibbixxi 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: 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: Lilly France SAS Tél: +33-(0) 1 55 49 34 34
Maltese: Tél: +33-(0) 1 55
English: Children and adolescents There is no relevant use of ALIMTA in the paediatric population
Maltese: Tfal u adolexxenti M'hemm ebda użu rilevanti ta' ALIMTA fil-popolazzjoni pedjatrika.
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: Non-inferiority p-value (HR) Progression free survival (months) Median
Maltese: Il-valur-P (HR) mhux inferjuri Sopravivenza mingħajr progressjoni (xhur)
English: A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with ALIMTA, representing at least 10 total cycles of ALIMTA.
Maltese: Total ta' 169 pazjent (47.1%) spiċċaw ≥ 6 ċikli ta' kura ta' manteniment b'ALIMTA , li jirrappreżentaw għallinqas 10 ċikli sħaħ ta' ALIMTA.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA 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: Alimta 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: *** Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
Maltese: *** It-tabella tar-reazzjonijiet avversi unifikati tikkombina r-riżultati tal-istudji ta' manteniment b'pemetrexed JMEN (N=663) u tat-tkomplija ta' manteniment b'pemetrexed PARAMOUNT (N=539) **** Terminu li jiġbor kollox u jinkludi żieda fil-kreatinina fis-serum/demm, tnaqqis fir-rata ta'
English: ≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with ALIMTA.
Maltese: Kien hemm total ta' 213-il pazjent (48.3%) li temmew ≥ 6 ċikli u total ta' 103 pazjenti (23.4%) li temmew ≥ 10 ċikli ta' kura b'ALIMTA.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2004
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 2004
English: Other undesirable effects include renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis and neuropathy.
Maltese: Effetti mhux mixtieqa oħra jinkludu tossiċitajiet renali, żieda fit-aminotransferases, alopeċja, għeja, diżidratazzjoni, raxx,
English: EMPHACIS, a multicentre, randomised, single-blind phase 3 study of ALIMTA plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with ALIMTA 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'ALIMTA flimkien ma' cisplatin kontra cisplatin, f'pazjenti b'mesoteljoma plewrali malinna u li ma kienu ħadu ebda kimoterapija oħra,wera li pazjenti kkurati b'ALIMTA u cisplatin kellhom medjan ta' vantaġġ ta' sopravivenza klinikament sinifikanti ta' 2.8 xhur fuq pazjenti li rċevew cisplatin waħdu.
English: Skin rash
Maltese: Rash
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 l-gravità ta' reazzjonijiet fil-ġilda (ara sezzjoni 4.2).
English: Median time to tumour progression (months) (95 % CI)
Maltese: Żmien medjan fil-progress tat-tumur (xhur) (95 % CI)
English: Patients treated with ALIMTA 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'ALIMTA 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.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of ALIMTA and then approximately every 9 weeks (corresponding to 3 courses of ALIMTA treatment).
Maltese: B12 (1000 microgramma) fil-ġimgħa ta' qabel li tingħata ALIMTA u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura b'ALIMTA).
English: 50 % of previous dose
Maltese: 50 % tad-doża ta' qabel
English: Each vial contains approximately 54 mg sodium.
Maltese: Kull kunjett fih madwar 54 mg ta' sodium.
English: Time to treatment failure (TTTF - months) Median
Maltese: Żmien sal-falliment tal-kura (TTTF - xhur) Medjan
English: Efficacy of ALIMTA + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Maltese: L-Effikaċja ta' ALIMTA + cisplatin vs. gemcitabine + cisplatin fl-linja ta' kura tal-kanċer talpulmun mhux b'ċelluli żgħar- popolazzjoni ITT u sottogruppi istoloġiċi.
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of ALIMTA 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: 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: 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: Response (n: qualified for response) Response rate (%) (95 % CI) Stable disease (%)
Maltese: Persentaġġ ta' respons (%) (95 % CI)
English: Taste disturbance
Maltese: Twissijiet u prekawzjonijiet
English: Table 3 - Dose modification table for ALIMTA (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: TABELLA 3 - Tabella għall-modifikazzjoni fid-doża ta' ALIMTA (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Newrotossiċità
English: Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection.
Maltese: Pemetrexed mhuwiex kompatibbli ma' diljuwenti li fihom il-kalċju, inklużi l-injezzjoni ta' lactated Ringer u linjezzjoni ta' Ringer.
English: The overall response rate was 14.1 %.
Maltese: 2% konta 1.9%,
English: Pemetrexed has a steady-state volume of distribution of 9 l/m2.
Maltese: pazjent bil-kanċer li kellhom diversi tumuri solidi.Pemetrexed għandu volum tad-distribuzzjoni fiss ta' 9 l/m2 .
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: 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: 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: Consistent with other ALIMTA studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Maltese: Konsistenti ma' studji oħra ta' ALIMTA, f'JMEN ġiet osservata differenza fl-effikaċja skont listoloġija tal-NSCLC.
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: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with ALIMTA 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: (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' manteniment b' ALIMTA 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: CTC a Grade
Maltese: Grad CTCa
English: Nausea
Maltese: Prurite
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: Other medicines and ALIMTA
Maltese: Mediċini oħra u ALIMTA
English: The recommended dose of ALIMTA 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' ALIMTA hi ta' 500 mg/m2 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: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival ALIMTA versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Maltese: Dijagrammi Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u sopravivenza totali ALIMTA kontra plaċebo f'pazjenti b' NSCLC minbarra dwak fejn listoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous:
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, leukopenia, 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, newtropinja,lewkopinja, tromboċitopinja;u tossiċitajiet gastrointestinali li jidhru bħala anoressija, dardir, rimettar dijarrea, stitikezza, farinġite, mukosite u stomatite.
English: Data from the originator medicinal product identified 141 cases of pigmentation disorders such as hyperpigmentation (n=48) and pigmentation disorders NEC (n=80) corresponding mostly to blackish or increased pigmentation, positive de-challenge and positive re-challenge in a number of cases was also described.
Maltese: Tagħrif mill-prodott mediċinali oriġinali identifika 141 każ ta' disturbi ta' pigmentazzjoni bħal iperpigmentazzjoni (n=48) u disturbi ta' pigmentazzjoni NEC (n=80) li jikkorrispondu l-aktar għal pigmentazzjoni li tkun aktarx sewda jew li tkun qed tiżdied, f'numru ta' każijiet ġie deskritt ukoll tnaqqis fil-pigmentazzjoni meta titwaqqaf ilmediċina u żieda fil-pigmentazzjoni meta din terġa' tingħata.
English: NSCLC, first-line treatment
Maltese: NSCLC, l-ewwel linja ta' kura
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: The median OS for the overall population (n = 663) was 13.4 months for the ALIMTA arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI = 0.65-0.95, p = 0.01192).
Maltese: ALIMTA u ta' 10.6 xhur għall-fergħa tal-plaċebo, hazard ratio= 0.79 (95% CI = 0.65 - 0.95; p = 0.01192).
English: Rash/ desquamation Common Pruritus Alopecia
Maltese: Raxx/ deskwamazzjoni
English: ALIMTA 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Maltese: ALIMTA 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 500 mg ta' pemetrexed (bħala pemexetred disodium).
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: SGOT (AST) elevation
Maltese: TWISSIJA(IET) SPEĊJALI
English: Adjusted hazard ratio (HR) (95% CI)
Maltese: Sopravivenza globali medjana (xhur) (95 % CI)
English: Haemoglobin decreased
Maltese: Tnaqqis flemoglobina
English: Marketing Authorisation Holder Eli Lilly Nederland B.V.
Maltese: Eli Lilly Nederland B.V.
English: Between patient variability in clearance is moderate at 19.3 %.
Maltese: Il-varjabilità fit-tneħħija bejn il-pazjenti hija moderata f'perċentwali ta' 19.3%.
English: The dose of ALIMTA is 500 milligrams for every square metre of your body's surface area.
Maltese: Id-doża ta' ALIMTA hi 500 milligramma għal kull metru kwadru ta' l-erja tas-superfiċje tal-ġisem tiegħek.
English: Stomatitis/
Maltese: Uġigħ
English: 100 % of previous dose
Maltese: 100 % tad-doża ta' qabel
English: All patients included in this study had an ECOG performance status 0 or 1.
Maltese: Il-pazjenti kollha inklużi f'dan l-istudju kellhom ECOG performance status ta' 0 jew 1.
English: ALIMTA 500 mg powder for concentrate for solution for infusion This medicinal product contains approximately 54 mg of sodium per vial.
Maltese: ALIMTA 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċinali fih madwar 54 mg ta' sodium f'kull kunjett.
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 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: Low haemoglobin level (anaemia) Low platelet count
Maltese: Livell baxx ta' emoglobina (anemija)
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Maltese: Il-pazjenti għandhom jieħdu b'mod orali folic acid jew xi prodott multivitaminiku li jkun fih folic acid (minn 350 sa 1,000 mikrogramma) kuljum.
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).
English: Frequency
Maltese: Frekwenza*
English: ALIMTA 100 mg powder for concentrate for solution for infusion This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree'.
Maltese: ALIMTA 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċinali fih inqas minn mmol 1 ta' sodium (23 mg) f'kull kunjett, jiġifieri tista' tgħid li huwa ‘hieles mis-sodium'.
English: *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Maltese: *** Skont is-CTC (v2.0; NCI 1998) ta' l-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u l alopeċja għandhom jiġu rrapportati biss bħala Grad 1 jew 2.
English: ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed
Maltese: ALIMTA 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni pemetrexed
English: During a periodic regulatory review of the use of pemetrexed a number of cases describing pigmentation disorders has been described with a common frequency.
Maltese: Waqt evalwazzjoni perjodika regulatorja dwar l-użu ta' pemetrexed, ġew deskritti numru ta' każijiet ta' disturbi ta' pigmentazzjoni rrapportati b'frekwenza komuni.
English: Common Taste disturbance Eye disorders Common Conjunctivitis
Maltese: Disturbi fissistema nervuża Komuni
English: EXPIRY DATE
Maltese: DATA TA'SKADENZA
English: ALIMTA (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: ALIMTA (pemetrexed) hija sustanza antifolatika, antikanċeroġenika u għandu iżjed minn obbjettiv wieħed.
English: Patients in both study arms were fully supplemented with folic acid and vitamin B12.
Maltese: Il-pazjenti fiż-żewġ fergħat tal-istudju ġew mogħtija l folic acid u l-vitamina B12.
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Maltese: *** Skont is-CTC (v 2.0; NCI 1998)ta' l-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u l alopeċja għandhom jiġu rrapportati bħala Grad 1 jew 2 biss.
English: ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed
Maltese: ALIMTA 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: The ALIMTA maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Maltese: Il-profili ta' sigurtà dwar il-manteniment b'ALIMTA kienu simili għaż-żewġ studji JMEN u PARAMOUNT.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/290/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/290/001
English: In the data from the originator product, 91 cases of cellulitis, 42 of dermatitis, 13 cases of dermo-hypodermitis, and 3 cases of pseudocellulitis were identified.
Maltese: Minn tagħrif mill-prodott oriġinali ġew identifikati 91 każ ta' ċellulite, 42 ta' dermatite, 13-il każ ta' dermo-ipodermatite u 3 każi ta' psewdoċellulite.
English: Efficacy of ALIMTA plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated
Maltese: Effikaċja ta' ALIMTA ma' cisplatin vs. cisplatin f'mesoteljoma plewrali malinna
English: Rash Alopecia
Maltese: Alopeċja
English: The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
Maltese: Il- farmakokinetiċi ta' pemetrexed huma konsistenti f'diversi ċikli ta' kura.