FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipients: Mannitol (E 421), hydrochloric acid , sodium hydroxide (see package leaflet for further information).
Maltese: Eċċipjenti: Mannitol (E 421), hydrochloric acid, sodium hydroxide (ara l-fuljett ta' tagħrif għal aktar informazzjoni).
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking CIAMBRA.
Maltese: Supplimentazzjoni b'vitamini: it-tabib tiegħek jordnalek folic acid (vitamina) orali jew xi prodott multivitaminiku li fih folic acid (350 sa 1000 mikrogramma) li trid tieħu darba kuljum waqt ittrattament b' CIAMBRA.
English: Pharmacotherapeutic group: antineoplastic agent, folic acid analogues, ATC code: L01BA04
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, analogi ta' folic acid, Kodiċi ATC:
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 (16.1% kontra 27.3%, p<0.001) u trasfużjonijiet ta' plejtlits (1.8% kontra 4.5%, p=0.002).
English: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Maltese: Iddata tal-PFS ġew parzjalment ikkonfermati minn stħarriġ indipendenti (400/1725 pazjent ġew magħżula b'mod arbitrarju għall-istħarriġ).
English: Pemetrexed*** (N =800)
Maltese: Frekwenza* Avveniment** Pemetrexed*** (N =800)
English: Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection.
Maltese: Pemetrexed huwa fiżikament inkompatibbli ma' dilwenti li fihom il-kalċju, inklużi l-injezzjoni ta' lactated Ringer u l-injezzjoni ta' Ringer.
English: Response (n: qualified for response) Response rate (%) (95 % CI) Stable disease (%)
Maltese: Rispons (n: eliġibbli għar-rispons) Rata ta' rispons (%) (95 % CI) Marda stabbli (%)
English: The pH of the reconstituted solution is between 6.6 and 7.8 The Osmolality of the reconstituted solution is 230-270 mOsmol/kg
Maltese: L-osmolalità tas-soluzzjoni rrikostitwita hija 230-270 mOsmol/kg
English: For instructions on reconstitution and dilution of CIAMBRA before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwizzjoni ta' CIAMBRA qabel lamministrazzjoni, ara sezzjoni 6.6.
English: - The other ingredients are mannitol (E 421), hydrochloric acid (pH adjustment) and sodium hydroxide (pH adjustment) (see section 2, “Ciambra contains sodium”).
Maltese: - Is-sustanzi l-oħra huma mannitol (E421), hydrochloric acid (pH adjustment) u sodium hydroxide (għal-aġġustament tal-pH) (ara sezzjoni 2, “Ciambra fih sodium”).
English: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare
English: 95% CI = 1.08-2.26, p = 0.018).
Maltese: 64-0.96, p=0.0195).
English: Preparation and administration precautions:
Maltese: Prekawzjonijiet fil-preparazzjoni u l-amministrazzjoni:
English: 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: Dan il-prodott mediċinali fih 54 mg sodium f'kull kunjett, ekwivalenti għal 2,7% tal-ammont massimu rakkomandat mill-WHO ta 2 g sodium li għandu jittieħed kuljum minn adult.
English: 75 % of previous dose (both CIAMBRA and cisplatin)
Maltese: 75 % tad-doża ta' qabel (kemm CIAMBRA kif ukoll cisplatin).
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' tumur.
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 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: Patients with renal impairment (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method)
Maltese: Pazjenti b'indeboliment tal-kliewi (Formula Standard Cockcroft & Gault jew Metodu tat-tneħħija misserum Tc99m-DPTA biex tiġi kkalkulata r-Rata ta' Filtrazzjoni Glomerulari) Pemetrexed primarjament jiġi eliminat bla ebda modifikazzjoni permezz ta' tneħħija mill-kliewi.
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Maltese: Kategorija farmakoterapewtika: sustanza antineoplastika, analogi ta' folic acid, Kodiċi ATC:
English: How to store CIAMBRA
Maltese: Tużax CIAMBRA
English: CIAMBRA 500 mgcontains 54 mg sodium (main component of cooking salt) in each vial.
Maltese: CIAMBRA 500 mg Din il-mediċina fiha 54 mg sodium (il-komponent prinċipali tal-melħ tattisjir) f'kull kunjett.
English: CIAMBRA 100 mg contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Maltese: CIAMBRA 100 mg Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment‘ħieles mis-sodium'.
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: Log Rank p-value* Time to treatment failure (months) (95 % CI)
Maltese: Log Rank p-value* Żmien sal-falliment fil-kura (xhur) (95 % CI)
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: Creatinine clearance decreased**
Maltese: Tnaqqis fittneħħija talkreatinina**
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 ingħatat id-doża.
English: There is no relevant use of CIAMBRA in the paediatric population.
Maltese: M'hemm ebda użu rilevanti ta' CIAMBRA fil-popolazzjoni pedjatrika.
English: Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority 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 <0.001).
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of CIAMBRA and then approximately every 9 weeks (corresponding to 3 courses of CIAMBRA treatment).
Maltese: B12 (1000 mikrogramma) fil-ġimgħa ta' qabel li tingħata CIAMBRA u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura b' CIAMBRA).
English: Chemical and physical in-use stability of the infusion solution of pemetrexed was demonstrated for 24 hours at 2°C-8°C or 15-25°C.
Maltese: L-istabbilità kimika u fiżika ta' waqt l-użu tas-soluzzjoni tal-infużjoni ta' pemetrexed ġiet ippruvata għal 24 siegħa f'temperatura ta' 2°C-8°C jew 15-25°C.
English: Other medicines and CIAMBRA
Maltese: Mediċini oħra u CIAMBRA
English: 95 % CI for HR Non-inferiority p-value (HR)
Maltese: 95 % CI għal HR Il-valur-P (HR) mhux inferjuri
English: Immune-mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Maltese: Anemija emolitika medjata mis-sistema immuni (qerda ta' ċelluli ħomor tad-demm medjata minn antikorpi)
English: Name and address of the manufacturer responsible for batch release Oncotec Pharma Produktion GmbH Am Pharmapark
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Oncotec Pharma Produktion GmbH
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;
Maltese: Analiżi tal-impatt tal-istoloġija ta' NSCLC fuq l-effett tat-trattament fuq is-sopravivenza kienet favur 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 kienet favur docetaxel għal 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 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 inġenerali (n= 663) kien ta' 13.4 xhur għall-fergħa ta' pemetrexed u ta' 10.6 xhur għall-fergħa tal-plaċebo, proporzjon ta' riskju= 0.79 (95 %CI = 0.650.95; p = 0.01192.
English: The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N=519), and compared to patients who received > 6 cycles of pemetrexed (N=281).
Maltese: L-inċidenza ta' reazzjonijiet avversi ġiet analizzata f pazjenti li rċevew ≤ 6 ċikli ta' manteniment b'pemetrexed (N=519), u mqabbla mal-pazjenti li rċevew > 6 ċikli ta' pemetrexed (N=281).
English: This is equivalent to 2,7% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 2,7% tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: 50% of previous dose (both CIAMBRA and cisplatin)
Maltese: 50 % tad-doża ta' qabel (kemm CIAMBRA kif ukoll cisplatin).
English: CY MENARINI HELLAS AE Τηλ: +30 210 8316111-13
Maltese: Τηλ: +30 210 8316111-13
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 tal-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: Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Each vial contains 500 mg ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Table 2 - Dose modification table for CIAMBRA (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b
Maltese: Tabella 2 - tabella għall-modifikazzjoni fid-doża ta' CIAMBRA (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin- tossiċitajiet li mhumiex ematoloġiċi a, b
English: For storage conditions after reconstitution/dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: NSCLC, first-line treatment:
Maltese: NSCLC, it-tieni linja ta' kura:
English: Pemetrexed has a steady-state volume of distribution of9 l/m2.
Maltese: Pemetrexed għandu volum tad-distribuzzjoni fl-istat fiss ta' 9 l/m
English: A multicentre, 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 (PARAMOUNT), 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 NSCLC 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 wrew ebda progress wara 4 ċikli ta' par ta' kura tal-ewwel linja b'pemetrexed flimkien ma' cisplatin.
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the pemetrexed arm versus 21.7% on the placebo arm.
Maltese: Fil-ħin ta' din l-analiżi finali ta' sopravivenza, 28.7% talpazjenti kienu ħajjin jew ma baqgħux jiġu segwiti fuq il-fergħa ta' pemetrexed kontra 21.7% fuq ilfergħa ta' plaċebo.
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: 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: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornamenti sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
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 temporanju ġew irrapportati b'mod mhux komuni matul listudji kliniċi b'pemetrexed, ħafna drabi meta ngħata ma' sustanza ċitotossika oħra.
English: Table 1 - Dose modification table for CIAMBRA (as single agent or in combination) and cisplatin - Haematologic toxicities
Maltese: Tabella 1 - Tabella għall-modifikazzjoni fid-doża ta' CIAMBRA (bħala sustanza waħedha jew f'terapija kombinata) u cisplatin - Tossiċitajiet ematoloġiċi
English: CIAMBRA 100 mg powder for concentrate for solution for infusion CIAMBRA 500 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Informazzjoni għall-utent CIAMBRA 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni CIAMBRA 500 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni 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 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 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: An insufficient number of patients has been studied with creatinine clearance of below 45 ml/min.
Maltese: Ġew studjati numru insuffiċjenti ta' pazjenti bi tneħħija tal-kreatinina ta' inqas minn 45 ml/min.
English: EXP
Maltese: Pha
English: When using CIAMBRA in combination with cisplatin:
Maltese: Meta tuża CIAMBRA flimkien ma' cisplatin:
English: Each 10 mL vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Each vial contains 100 mg ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
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 bl-Intenzjoni Li Jiġu Kkurati [ITT - Intent To Treat], n = 283) u 7.9 xhur f'pazjenti kkurati b'docetaxel (ITT n = 288).
English: CIAMBRA in combination with cisplatin The recommended dose of CIAMBRA 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: CIAMBRA flimkien ma' cisplatin Id-doża rakkomandata ta' CIAMBRA hija 500 mg/m tal-erja tas-superfiċje tal-ġisem (BSA) mogħtija bħala infużjoni minn ġol-vina fuq perjodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
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) tal-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u l-alopeċja għandhom jiġu rrapportati bħala Grad 1 jew 2 biss.
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 mill-inqas 10 ċikli sħaħ ta' pemetrexed.
English: The vial is covered with a shrink-wrapped plastic sleeve .
Maltese: Kull pakkett fih kunjett wieħed.
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 aspirin at higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Maltese: F'pazjenti b'funzjoni normali tal-kliewi (tneħħija tal-krejatinina ≥ 80 ml/min), dożi għolja ta' mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs - non-steroidal anti-inflammatory drugs, bħal ibuprofen > 1600 mg/kuljum) kif ukoll doża għolja ta' aspirina (≥ 1.3 g kuljum) jistgħu jnaqqsu leliminazzjoni ta' pemetrexed u, b'hekk, tiżdied l-inċidenza ta' każijiet avversi ta' pemetrexed.
English: You must continue taking the folic acid for 21 days after the last dose of CIAMBRA.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' CIAMBRA.
English: Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis
Maltese: Kundizzjonijiet bullużi (mard tal-ġilda b'ħafna nfafet)- li jinkludu s-sindromu ta' Stevens-Johnson u Nekrożi epidermali tossika
English: Rash/ desquamation
Maltese: Raxx/ deskwamazzjoni
English: Sepsis, sometimes fatal, has been commonly reported during clinical trials with pemetrexed.
Maltese: Sepsis, xi kultant fatali, ġiet rrapportata b'mod komuni fi provi kliniċi b'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 il-fergħa ta' plaċebo (n = 581, popolazzjoni analizzata indipendentement; medjan ta' 4.0 xhur u 2.0 xhur, rispettivament) (proporzjon ta' riskju= 0.60, 95%CI = 0.49-0.73, p < 0.00001).
English: Patients should be regularly monitored for acute tubular necrosis, decreased renal function and signs and symptoms of nephrogenic diabetes insipidus (e.g. hypernatraemia).
Maltese: Ilpazjenti għandhom jiġu mmonitorjati regolarment għal nekrożi tubulari akuta, funzjoni renali indebolita u sinjali u sintomi ta' inspidus taddijabete nefroġenika (eż. ipernatremija).
English: After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjoni, kull kunjett ikun fih 25 mg/ml ta' pemetrexed.
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-ewwel linja ta' kura talkanċer tal-pulmun mhux b'ċelluli żgħar- popolazzjoni ITT u sottogruppi istoloġiċi.
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 =
Maltese: Informazzjoni klinika limitata, minn prova separata, kkontrollata u, randomised ta' Fażi 3, tissuġġerixxi li l-informazzjoni dwar l-effikaċja (sopravivenza totali, sopravivenza mingħajr progressjoni) għal pemetrexed hija 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: Constipation
Maltese: Disturbi