FrancophonIA/ELRC3.0 huggingface dataset:
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 irrappurtati b'mod komuni u li għandhom x'jaqsmu ma' pemetrexed kemm jekk intuża bħala monoterapija kif ukoll jekk jintuża flimkien ma' prodotti mediċinali oħra huma t-tnaqqis fil-funzjoni tal-mudullun tal-għadam li jidher bħala anemija, newtropenja, lewkopenja, tromboċitopenja; u tossiċitajiet gastrointestinali li jidhru bħala anoressija, dardir, rimettar dijarrea, stitikezza, farinġite, mukosite u stomatite.
English: Common Vomiting Mucositis/ stomatitis
Maltese: Common Newropatija tassensazzjoni
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: Graff Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u sopravivenza totali pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous:
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 aspirin (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section
Maltese: Pazjenti b'insuffiċjenza renali minn ħafifa għal moderata (tneħħija ta' kreatinina bejn 45 u 79 ml/min) għandhom jevitaw li jieħdu mediċini antiinfjammatorji li mhumiex sterojdi (NSAIDs) bħal ibuprofen, u aspirina (> 1.3 g kuljum) minn jumejn qabel, dakinhar, u sa jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.5).
English: CIAMBRA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: CIAMBRA 500 mg: Kull kunjett fih 500 milligrams ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
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: -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. xhur u 2.6 xhur rispettivament) (proporzjon ta' riskju = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Maltese: ITT = intenzjoni li tikkura; n = daqs tal-popolazzjoni kollha.
English: Table 3 - Dose modification table for CIAMBRA (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: Tabella 3 - Tabella għall-modifikazzjoni fid-doża ta' CIAMBRA (bħala sustanza waħedha jew f'terapija kkombinata) u cisplatin - Newrotossiċità Grad CTC
English: Statistically significant differences in pulmonary function tests were also observed.
Maltese: Differenzi statistikament sinifikanti kienu osservati wkoll fit-testijiet tal-funzjoni talpulmun.
English: Patients in both study arms were fully supplemented with folic acid and vitamin B12.
Maltese: Il-pazjenti fiż-żewġ fergħat tal-istudju ġew mogtija lfolic acid u l-vitamina B12.
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: Common Taste disturbance
Maltese: Disturbi fissistema nervuża Komuni
English: CIAMBRA 500 mg powder for concentrate for solution for infusion Pemetrexed
Maltese: CIAMBRA 500 mg tab għal konċnetrat għall-soluzzjoni għall-infużjoni Pemetrexed
English: After reconstitution (see section 6.6), each vial contains 25 mg/mL of pemetrexed.
Maltese: Wara r-rikostituzzjoni (ara sezzjoni 6.6), kull kunjett fih 25 mg/mL ta' pemetrexed. Eċċipjenti b'effett magħruf:
English: Fatigue Common Fever
Maltese: Żieda filkreatinina
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Maltese: Il-volum xieraq tas-soluzzjoni rikostitwita ta' pemetrexed irid jerga' jiġi dilwit sa 100 ml b' soluzzjoni għall-injezzjoni ta' 9 mg/ml(0.9%)sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
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, and administered as an intravenous infusion over 10 minutes.
Maltese: Il-volum xieraq tas-soluzzjoni rikostitwita ta' pemetrexed irid jerġa' jiġi dilwit sa 100 ml b' soluzzjoni għall-injezzjoni ta' 9 mg/ml(0.9%)sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
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% tal-pazjenti li b'mod arbitrarju ġew magħżula biex jirċievu pemetrexed jinkludu: newtropenja bid-deni, infezzjoni, tnaqqis fil-plejtlits, dijarea, stitikezza, alopeċja, ħakk, deni (fin-nuqqas ta' newtropenja), mard fissuperfiċji tal-għajn (inkluża l-konġuntivite), żieda fit-tixrid ta' dmugħ, sturdament u newropatija motorja.
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Maltese: It-tabella taħt tati l-frekwenza u s-severità tal-effetti mhux mixtieqa li ġew irrapportati f > 5% tal-265 pazjent li ntgħażlu b'mod arbitrarju biex jirċievu pemetrexed waħdu b'supplimentazzjoni ta' folic acid u vitamina
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f'< 1% tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu cisplatin u pemetrexed jinkludu arritmja u newropatija motorja.
English: In clinical trials, cases of colitis (including intestinal and rectal bleeding, sometimes fatal, intestinal perforation, intestinal necrosis and typhlitis) have been reported uncommonly in patients treated with pemetrexed.
Maltese: Fi studji kliniċi, b'mod mhux komuni, ġew irrapportati każijiet ta' kolite (li jinkludu fsada intestinali u rettali, xi kultant fatali, perforazzjoni intestinali, nekrożi intestinali u tiflite), f pazjenti kkurati b'pemetrexed.
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% 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: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Maltese: Tossiċitajiet klinikament rilevanti li ġew irrapportati f'≥ 1% u ≤ 5% tal-pazjenti li ntgħażlu b'mod arbitrarju biex jirċievu cisplatin u pemetrexed jinkludu: żieda fl-AST, żieda fl-ALT, infezzjoni, newtropenja bid-deni, insuffiċjenza renali, deni, deidratazzjoni, konġuntivite u tnaqqis fit-tneħħija ta' kreatinina.
English: Common Neuropathysensory
Maltese: Newropatijatassensazzjoni
English: PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Maltese: Graff Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u Sopravivenza Totali (OS) għat-tkomplija ta' manteniment bi pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous (kkwantifikat permezz ta' għażla b'mod arbitrarju)
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f'> 1% u < 5% tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu pemetrexed jinkludu: infezzjoni mingħajr newtropenja, newtropenja biddeni, reazzjoni allerġika/sensittivita aċċessiva, żieda fil-krejatinina, newropatija motorja, newropatija tas-sensazzjoni, eritema multiforme u wġigħ addominali.
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 tas-sensaazzjoni, u raxx.
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 perjodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: CIAMBRA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: CIAMBRA 100 mg: Kull kunjett fih 100 milligrams ta' pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Once in the cell, pemetrexed is rapidly and efficiently converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase.
Maltese: Ladarba jkun fiċ-ċellula, pemetrexed jiġi konvertit malajr u b'mod effiċjenti f'forom ta' poliglutamati permezz tal-enzima folylpolyglutamate synthetase.
English: For precautions to be taken before handling or administering CIAMBRA, see section 6.6.
Maltese: Għal prekawzjonijiet li għandhom jittieħdu qabel ma tmiss jew tamministra CIAMBRA, ara sezzjoni 6.6.
English: This suggests that pemetrexed may impair male fertility.
Maltese: Irriskju jikber f persuni li jkunu diġà immunosoppressi minħabba l-marda li jkollhom.
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Maltese: Meta tinkludi l-fażi tal-induzzjoni l-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous kien ta' 18.6 xhur għall-fergħa ta' pemetrexed u ta' 13.6 xhur għall-fergħa tal-plaċebo (proporzjon ta' riskju =0.71, 95% CI = 0.56-0.88, p = 0.002).
English: Grade 34 toxicity
Maltese: Grad ta' tossiċi tà 3
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/m2 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 perjodu ta' għaxar minuti f'426 pazjent bil-kanċer li kellhom varjetà ta' tumuri solidi.
English: A hospital pharmacist, nurse or doctor will have mixed the CIAMBRA powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Maltese: Qabel ma' jingħatalek, it-trab ta' CIAMBRA jiġi mħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mill-ispiżjar talisptar, infermier jew tabib.
English: Pemetrexed was not mutagenic in either the in vitro chromosome aberration test in Chinese hamster ovary cells, or the Ames test. Pemetrexed has been shown to be clastogenic in the in vivo micronucleus test in the mouse.
Maltese: Pemetrexed ma kienx mutaġeniku kemm fit-test in vitro ta' aberrazzjoni kromosomali li sar fuq iċċelluli ovarji tal-ħamster Ċiniż kif ukoll fit-test Ames.
English: CIAMBRA 100 mg powder for concentrate for solution for infusion Pemetrexed
Maltese: CIAMBRA 100 mg tab għal konċnetrat għall-soluzzjoni għall-infużjoni Pemetrexed
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: (n = 441) ma' dik ta' plaċebo flimkien ma' BSC (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' par ta' kura tal-ewwel linja li kien fih Cisplatin jew Carboplatin flimkien ma' Gemcitabine, Paclitaxel jew Docetaxel.
English: Use an inactivated vaccine where it exists (poliomyelitis) (see section 4.4).
Maltese: Uża vaċċin inattivat jekk ikun jeżisti (poljomijelite) (ara sezzjoni 4.4).
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kunjetti ta' 100mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodjum (23 mg) f'kull kunjett, i.e. huwa essenzjalment ‘ħieles mis-sodjum'.
English: Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 500 mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed
English: Nadir platelets <50,000 /mm regardless of nadir ANC
Maltese: Fwied: testijiet tad-demm anormali
English: CTC
Maltese: PC:
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: B'frekwenza mhux magħrufa ġew irrapportati disturbi infettivi u mhux infettivi tad-dermis, lipodermis u/jew tat-tessut ta' taħt il-ġilda (eż. dermo-ipodermite batterjali akuta, psewdoċellulite, dermatite).
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Maltese: 3 xhur għall-fergħa tal-plaċebo (proporzjon ta' riskju = 0.70, 95% CI = 0.56-0.88, p=0.002).
English: The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Maltese: Minħabba li fl-istess individwu jkun hemm varjabilità kbira fl-istat ta' koagulazzjoni waqt il-mard u l possibilità ta' interazzjoni bejn antikoagulanti li jittieħdu b'mod orali u l-kimoterapija kontra l-kanċerikun hemmbżonn ta' monitoragg tal-INR (International Normalised Ratio) aktar spiss, jekk ikun deċiż li l-pazjent għandu jingħatalu kura b'antikoagulanti orali.
English: Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
Maltese: In-nisa li jista' jkollhom it-tfal għandhom jużaw kontraċezzjoni effettiva waqt il-kura b'pemetrexed (ara sezzjoni 4.6).
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95 % CI = 0.64-0.96, p = 0.0195).
Maltese: Wara li bdiet il-kura b'pemetrexed flimkien ma' cisplatin (4 ċikli), il-kura bi pemetrexed kienet statistikament superjuri għal plaċebo għall-OS (medjan 13.9 xhur kontra 11.0 xhur, proporzjoni ta' riskju = 0.78, 95%CI=0.
English: In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min), the concomitant administration of pemetrexed with NSAIDs (e.g. ibuprofen) or aspirin at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Maltese: F'pazjenti li jkollhom insuffiċjenza renali ħafifa għal moderata (tneħħija tal-kreatinina bejn 45 u 79 ml/min) l-għoti ta' pemetrexed fl-istess żmien ma' NSAIDs (eż. ibuprofen) jew aspirina f'dożi għoljin għandu jkun evitat minn jumejn qabel, dakinhar u sa jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.4).
English: Paclitaxel, or Docetaxel.
Maltese: - Żomm dan il-fuljett.
English: As a result there is sufficient evidence suggesting a causal relationship between the use of pemetrexed and infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue including acute bacterial dermo-hypodermitis, cellulitis, pseudocellulitis and dermatitis.
Maltese: B'hekk jirriżulta li hemm evidenza suffiċjenti li tissuġġerixxi relazzjoni kawżali bejn l-użu ta' pemetrexed u disturbi infettivi u mhux infettivi tad-dermis, l-ipodermis u/jew tat-tessut ta' taħt il-ġilda inkluż dermoipodermatite batterjali akuta, ċellulite, psewdoċellulite u dermatite.
English: Efficacy of pemetrexed plus cisplatin vs.cisplatin in malignant pleural mesothelioma Randomized and treated patients
Maltese: Effikaċja ta' pemetrexed ma' cisplatin vs. cisplatin f'mesoteljoma plewrali malinna in azjenti magħżula b'mod arbitrarju u kkurati patients
English: CIAMBRA (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: CIAMBRA (pemetrexed) hija sustanza antifolatika, antikanċeroġenika b'iżjed minn obbjettiv wieħed li taħdem billi tfixkel proċessi metaboliċi kruċjali li jiddipendu mill-folat u li huma essenzjali għarreplikazzjoni taċ-ċelluli.
English: In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Maltese: Fin-nuqqas ta' tagħrif dwar l-interazzjoni potenzjali ma' NSAIDs li jkollhom half-life itwal bħal piroxicam jew rofecoxib, l-għoti ta' pemetrexed fl-istess żmien f'pazjenti b'insuffiċjenza renali minn ħafifa għal moderata għandu jitwaqqaf mill-anqas minn 5 ijiem qabel, dakinhar u mill-inqas jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.4).
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f'< 1 % tal-pazjenti li ntgħażlu b'mod arbitrarju biex jirċievu pemetrexed jinkludu arritmji supraventrikulari.
English: All patients were diagnosed with Stage IIIB or IV NSCLC and had received prior platinumbased chemotherapy.
Maltese: Il-pazjenti kollha kienu ddijanjostikati li kellhom NSCLC fi Stadju IIIB je IV u li diġà kienu rċevew kemoterapija bbażata fuq il-platinum.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of CIAMBRA 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' CIAMBRA.
English: Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 100 mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed
English: EU Number
Maltese: EU/1/99/108/004
English: Packaging
Maltese: Kontenut Daqs talpakkett
English: bottle (HDPE) with child-resistant closure bottle (HDPE) with screw cap blister (alu/alu)
Maltese: EU/1/99/108/006 Ferriprox 1000 mg Pilloli miksija b'rita Jittieħed mill-ħalq folja (alu/alu)
English: Content Package size bottle (HDPE)
Maltese: EU/1/99/108/001 Ferriprox 500 mg Pilloli miksija b'rita Jittieħed mill-ħalq flixkun (HDPE)
English: Do not take DUTREBIS:
Maltese: Tiħux DUTREBIS:
English: BENCHMRK 1 and 2 Pooled
Maltese: BENCHMRK 1 u 2 Raggruppati
English: (UGT1A1 induction)
Maltese: (induzzjoni ta' UGT1A1)
English: Placebo + OBT (N = 237)
Maltese: Plaċebo + OBT (N = 237)
English: Final dose population N=96
Maltese: Popolazzjoni fid-doża finali N=96
English: Nucleoside/tide reverse transcriptase inhibitors (NRTIs)
Maltese: Inibituri ta' nucleoside reverse transcriptase (NRTIs)
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Maltese: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU Ir-Renju Unit
English: Percent HIV-RNA < 50 copies/ml (95 % CI)
Maltese: HIV-RNA perċentwali < 400 kopja/ml (95 % CI)
English: • The other ingredients are: hypromellose (2910), croscarmellose sodium, lactose monohydrate, silicon dioxide (colloidal), magnesium stearate, and microcrystalline cellulose.
Maltese: • Is-sustanzi l-oħra huma: hypromellose (2910), croscarmellose sodium, lactose monohydrate, silicon dioxide (colloidal), magnesium stearate, u microcrystalline cellulose.
English: BE/LU
Maltese: IL-PROVVISTA U L
English: 156 cells/mm
Maltese: 156 ċellola/mm
English: Pack size: 1 bottle containing 60 tablets.
Maltese: Daqs tal-pakkett: flixkun li fih 60 pillola.
English: • cladribine - used to treat hairy cell leukaemia.
Maltese: • cladribine - użat biex jikkura lewkimja tal-‘hairy cell'.