FrancophonIA/ELRC3.0 huggingface dataset:
English: The fourth study compared Multaq with amiodarone (another medicine used to prevent atrial fibrillation) in 504 patients.
Maltese: Ir-raba' studju qabbel Multaq ma' amiodaron (mediċina oħra li tintuża għall-prevenzjoni talfibrillazzjoni atrijali) f'504 pazjenti.
English: The first three studies, involving, 1,411 patients, found that Multaq was more effective than placebo (a dummy treatment) at preventing atrial fibrillation.
Maltese: L-ewwel tliet studji li involvew, 1,411-il pazjent, sabu li Multaq kien aktar effettiv minn plaċebo (kura finta) fil-prevenzjoni tal-fibrillazzjoni atrijali.
English: Why is Multaq approved?
Maltese: Għaliex ġie approvat Multaq?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Multaq on 26 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Multaq fis-26 ta' Novembru 2009.
English: Multaq is an antiarrhythmic medicine used to maintain normal heart rhythm in adults whose normal heart rhythm has been restored after a period of paroxysmal or persistent atrial fibrillation.
Maltese: Multaq huwa mediċina antiaritmika li tintuża biex iżżomm ritmu normali tal-qalb fl-adulti li r-ritmu talqalb normali tagħhom reġa' lura għan-normal wara perjodu ta' fibrillazzjoni atrijali persistenti jew parossistika.
English: There were six main studies of Multaq in adults who had had atrial fibrillation.
Maltese: Kien hemm sitt studji ewlenin ta' Multaq f'adulti li kellhom fibrillazzjoni atrijali.
English: A sixth study (PALLAS) compared Multaq with placebo in patients over 65 years of age with permanent atrial fibrillation and several risk factors.
Maltese: Is-sitt studju (PALLAS) qabbel Multaq ma' plaċebo f'pazjenti li għandhom aktar minn 65 sena b'fibrillazzjoni atrijali permanenti u diversi fatturi ta' riskju.
English: Multaq prevented fibrillation for an average of 116 days compared to 53 days with placebo.
Maltese: Multaq ipprevjena l-fibrillazzjoni għal medja ta' 116-il jum meta mqabbla ma' 53 jum bi plaċebo.
English: In September 2011 this indication was restricted to the maintenance of normal heart rhythm in ‘persistent' or ‘paroxysmal' atrial fibrillation after normal heart rhythm has been restored.
Maltese: F'Settembru 2011 din l-indikazzjoni kienet ristretta biex jinżamm ir-ritmu tal-qalb normali f'fibrillazzjoni atrijali ‘persistenti' jew ‘parossistika' wara li jerġa' jkun hemm ritmu tal-qalb normali.
English: Other information about Multaq
Maltese: Kif jintuża Multaq?
English: Atrial fibrillation is when the atria (the upper chambers of the heart) contract irregularly and rapidly, and this abnormality can be short-lasting (paroxysmal) or it can last longer than a few days (persistent).
Maltese: Il-fibrillazzjoni atrijali sseħħ meta l-atrija (il-kavitajiet ta' fuq tal-qalb) ikollhom kontrazzjonijiet irregolari u rapidi, u din l-abnormalità tista' tkun ta' perjodu qasir (parossistika) jew tista ddum aktar minn ftit jiem (persistenti).
English: Heart rate was reduced by an average of 11.0 beats per minute in patients taking Multaq compared to 0.7 beats per minute in patients taking placebo.
Maltese: Ittaħbita tal-qalb tnaqqset b'medja ta' 11.0-il taħbita fil-minuta f'pazjenti li jieħdu Multaq meta mqabbla ma' 0.7 taħbitiet fil-minuta f'pazjenti li jieħdu plaċebo.
English: Multaq is available as tablets (400 mg) and the recommended dose is one tablet twice a day, with the morning and evening meals.
Maltese: Multaq jiġi bħala pilloli (400 mg) u d-doża rakkomandata hija pillola darbtejn kuljum meħuda flimkien mal-ikel ta' filgħodu u ta' filgħaxija.
English: The guide will also include information on: when not to use Multaq; medicines that interact with Multaq; the need to monitor the function of the liver, lung, heart and kidneys before and during treatment; and what advice to give to patients on Multaq treatment.
Maltese: Il-gwida ser tinkludi wkoll informazzjoni dwar: meta m'għandekx tuża Multaq; il-mediċini li jinteraġixxu ma' Multaq; il-ħtieġa li l-funzjoni talfwied, il-pulmun, il-qalb u l-kliewi tiġi sorveljata qabel u matul il-kura; u x'parir għandu jingħata lillpazjenti dwar il-kura ta' Multaq.
English: The active substance in Multaq, dronedarone, works mainly by blocking channels through which charged particles of potassium flow in and out of the heart muscle cells.
Maltese: Is-sustanza attiva f'Multaq, id-dronedaron, taħdem l-aktar billi timblokka l-kanali li minnhom, partiċelli ċċarġjati ta' potassju, jidħlu u joħoġu miċ-ċelloli tal-muskoli tal-qalb.
English: Multaq must not be taken with medicines that can cause torsades de pointes (a type of rapid heart beat), or with dabigatran (a medicine to prevent blood clotting).
Maltese: Multaq m'għandux jittieħed ma' mediċini li jistgħu jikkawżaw torsades de pointes (tip ta' taħbit tal-qalb mgħaġġel), jew ma' dabigatran (mediċina li tipprevjeni l-emboli tad-demm).
English: Increased flow of charged particles produces the excessive electrical activity that leads to atrial fibrillation and rapid heart rate.
Maltese: Iż-żieda fil-fluss ta' partiċelli ċċarġjati tipproduċi l-attività elettrika eċċessiva li twassal għall-fibrillazzjoni atrijali u t-taħbit tal-qalb mgħaġġel.
English: By reducing the flow of potassium through the channels, Multaq slows down contractions in the atria and so prevents fibrillation and lowers the heart rate.
Maltese: Bit-tnaqqis tal-fluss tal-potassju permezz tal-kanali, Multaq inaqqas il-kontrazzjonijiet flatria u għalhekk jipprevjeni l-fibrillazzjoni u jbaxxi t-taħbit tal-qalb.
English: What are the risks associated with Multaq?
Maltese: Kif jaħdem Multaq?
English: Multaq was originally approved to prevent atrial fibrillation from coming back or to lower the heart rate in adults who have had or have non-permanent atrial fibrillation.
Maltese: Oriġinarjament Multaq kien approvat għall-prevenzjoni li terġa' sseħħ fibrillazzjoni atrijali jew biex ibaxxi r-ritmu tal-qalb f'adulti li kellhom jew li għandhom fibrillazzjoni atrijali mhux permanenti.
English: For the full list of all side effects reported with Multaq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Multaq, ara l-fuljett ta' tagħrif.
English: Multaq should only be prescribed after alternative treatment options have been considered.
Maltese: Multaq għandu jiġi preskritt biss wara li jkunu tqiesu għażliet ta' kura alternattivi.
English: Patients who have had previous liver or lung injury following treatment with amiodarone (another antiarrhythmic medicine) must not be given Multaq.
Maltese: Pazjenti li qabel kellhom ħsara fil-fwied jew fil-pulmun wara kura b'amiodaron (mediċina oħra kontra n-nuqqas talirregolarità) m'għandhomx jingħataw Multaq.
English: RO-011171 Bucharest Romania
Maltese: RO-011171 Bucharest Rumanija
English: Nerviano, Milan Italy
Maltese: Nerviano, Milan Italja
English: PLIVA CROATIA Ltd. 10000 Zagreb
Maltese: PLIVA CROATIA Ltd. 10000
English: Progression free survival (months)
Maltese: Survival Time (months)
English: *Definition of frequency terms: Very common - ≥10%; Common - >5% and <10%.
Maltese: Komuni ħafna- ≥ 10%; Komuni - > 5% and < 10%.
English: Superiority p-value
Maltese: Log Rank p-value*
English: 11 Ion Mihalache Blvd. 011171 Bucharest Romania
Maltese: Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd. 011171 Bucharest Rumanija
English: Date of first authorisation: 18 January 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Jannar 2016
English: Dose of pemetrexed (mg/m2)
Maltese: Doża ta' pemetrexed (mg/m2)
English: EU/1/15/1063/001 4 ml vial EU/1/15/1063/002 20 ml vial EU/1/15/1063/004 34 ml vial EU/1/15/1063/003 40 ml vial
Maltese: EU/1/15/1063/001 4 ml kunjett EU/1/15/1063/002 20 ml kunjett EU/1/15/1063/004 34 ml kunjett EU/1/15/1063/003 40 ml kunjett
English: Median HR (95 % CI)
Maltese: HR (95 % CI)
English: The percentage of patients that received post study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Maltese: Il-persentaġġ ta' pazjenti li rċevew kura wara listudju kien ta' 64.3% għal pemetrexed u 71.7% għal plaċebo.
English: The pH is between 7.0 and 8.0.
Maltese: Il-pH huwa bejn 7.0 għal 8.0.
English: Store and transport refrigerated (2°C to 8°C).
Maltese: Dan il-prodott għandu jiġi trasportat u maħżun fil-friġġ (2°C sa 8°C).
English: 11 Ion Mihalache Blvd.
Maltese: SINDAN-PHARMA S.R.L. 11 Ion Mihalache Blvd.
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 mis-serum Tc99m-DPTA biex tiġi kkalkulata r-Rata ta' Filtrazzjoni Glomerulari)
English: How to store Armisarte
Maltese: Tużax Armisarte
English: Excipients: trometamol, anhydrous citric acid, methionine and water for injections.
Maltese: Eċċipjenti: trometamol, anhydrous citric acid, methionine u ilma ta' l-injezzjonijiet.
English: Cytotoxic Must only be diluted in 5% glucose solution.
Maltese: Għandu jiġi dilwit b'soluzzjoni ta' 5% glucose.
English: For instructions on dilution of Armisarte before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq dilwizzjoni ta' pemetrexed qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Actavis Italy S.p.A. Viale Pasteur 10
Maltese: Viale Pasteur 10
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: 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: Frequency estimate: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to
Maltese: Komuni ħafna ( > 1/10 ), Komuni ( > 1/100 sa < 1/10), Mhux komuni ( > 1/1000
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04.
Maltese: Kategorija farmakoterapewtika: sustanzi antinejoplastiċi, analogi ta' folic acid, Kodiċi ATC:
English: 1 x 4 ml vial (100 mg/4 ml) 1 x 20 ml vial (500 mg/20 ml) 1 x 34 ml vial (850 mg/34 ml) 1 x 40 ml vial (1000 mg/40 ml)
Maltese: Qisien tal-Pakkett 1 x 4 ml kunjett (100 mg/4 ml) 1 x 20 ml kunjett (500 mg/20 ml) 1 x 34 ml kunjett (850 mg/34 ml) 1 x 40 ml kunjett (1000 mg/40 ml)
English: < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and not known (cannot be estimated from available data).
Maltese: sa < 1/100), Rari ( > 1/10,000 sa < 1/1000), Rari ħafna (≤ 1/10,000) u mhijiex magħrufa (ma tistax tiġi stimata mit-tagħrif li hemm disponibbli).
English: Time to treatment failure (TTTF - months)
Maltese: PFS Time (Months)
English: Trometamol is incompatible with cisplatin resulting in degradation of cisplatin.
Maltese: Trometamol huwa inkompatibbli ma' cisplatin u jirriżulta fid-degradazzjoni ta' cisplatin .
English: Armisarte must only be diluted with 5% glucose solution, without preservative.
Maltese: Armisarte għandu jiġi dilwit biss ma' soluzzjoni ta' 5% ta' glucose, mingħajr preservattivi.
English: Other medicines and Armisarte
Maltese: Mediċini oħra u Armisarte
English: CTCa Grade
Maltese: Grad CTCa
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95 % CI = 0.94-1.15), and overall response rate was 30.6% (95 % CI = 27.3-33.9) for pemetrexed plus cisplatin versus 28.2% (95 % CI = 25.0-31.4) for gemcitabine plus cisplatin.
Maltese: Il-medjan ta' PFS kien ta' 4.8 xhur għal pemetrexed flimkien ma' cisplatin kontra 5.1 xhur għal gemcitabine flimkien ma' cisplatin (proporzjon aġġustat ta' riskju 1.04; 95% CI = 0.94-1.15), u r-rata ta' rispons totali kien 30.6% (95% CI = 27.3- 33.9) għal pemetrexed flimkien ma' cisplatin kontra 28.2% (95% CI = 25.
English: Pemetrexed total systemic clearance is 91.8 ml/min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 ml/min).
Maltese: It-tneħħija sistemika totali ta' Pemetrexed hija ta' 91.8 ml/min u lhalf-life ta' l-eliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni tal-kliewi normali
English: 4 ml vial 20 ml vial 34 ml vial 40 ml vial
Maltese: 4ml kunjett 20ml kunjett 34ml kunjett 40ml kunjett
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 receiving Armisarte.
Maltese: Supplimentazzjoni b'vitamini: it-tabib tiegħek jordnalek folic acid (vitamina) orali jew xi prodott multivitaminiku li fih folic acid (350 sa 1000 microgramma) li trid tieħu darba kuljum waqt it trattament bi Armisarte.
English: Common Pain Oedema Renal Disorders Common Renal disorders**** Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT=serum glutamic oxaloacectic aminotransferase; SGPT=serum glutamic pyruvic aminotransferase.
Maltese: SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
English: National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: Komuni (CTC) ta' l-Istitut Nazzjonali tal-Kanċer (CTC v2.0; NCI 1998).
English: Response rate (%) (95 % CI) Stable disease (%)
Maltese: Persentaġġ ta' respons (%) (95 % CI)
English: Colourless glass vial (type I) with type I rubber (bromobutyl) serum stopper and an aluminium cap with polypropylene disk.
Maltese: Kunjett tal-ħġieġ mhux ikkulurit (tip I)b'tapp għas-serum tal-lasktu (bromobutyl) ta' Tip I u kappa tal-aluminium b'diska tal polypropylene.
English: Pemetrexed/ cisplatin (N=839)
Maltese: Frekwenza Avveniment** Pemetrexed/ cisplatin (N = 839)
English: 50% of previous dose 100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: 50 % tad-doża ta' qabel a Kriterji ta' Tossiċità Komuni ta' l-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998)
English: **In the pemetrexed/cisplatin arm, randomized and treated (N=225) and fully supplemented (N=167)
Maltese: ** Fil-fergħa ta' pemetrexed/cisplatin, ntgħażlu bl-addoċċ u kkurati (N = 225) u mogħtija suppliment tul itterapija kollha (N = 167)
English: Breast-feeding (see section 4.6).
Maltese: reazzjonijiet fil-ġilda (ara sezzjoni 4.2).
English: Armisarte 25 mg/ml sterile concentrate pemetrexed
Maltese: Armisarte25mg/ml konċentrat għal soluzzjoni għall-infużjoni pemetrexed
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: The appropriate volume of pemetrexed concentrate must be diluted to 100 ml with 5% glucose solution and administered as an intravenous infusion over 10 minutes.
Maltese: Ilvolum xieraq ta' konċentrat ta' pemetrexed għandu jiġi dilwit għal 100ml b' soluzzjoni ta' 5% glucose u amministrata bħala infużjoni fuq 10 minuti.
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,bi pemetrexed flimkien ma' cisplatin kontra cisplatin, f'pazjenti b'mesoteljoma plewrali malinna u li ma kienu ħadu ebda kimoterapija oħra,wera li pazjenti kkurati bi pemetrexed u cisplatin kellhom medjan ta' vantaġġ ta' sopravivenza klinikament sinifikanti ta' 2.8 xhur fuq pazjenti li rċevew cisplatin waħdu.
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 <.001).
English: Response (n: qualified for response)
Maltese: MANIFATTUR(I) RESPONSABBLI
English: You must continue taking the folic acid for 21 days after the last dose of Armisarte.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' Armisarte.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Armisarte and then approximately every 9 weeks (corresponding to 3 courses of Armisarte treatment).
Maltese: B12 (1000 microgramma) fil-ġimgħa ta' qabel li tingħata Armisarte u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura bi Armisarte).
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: Pemetrexed fuq dik il-fergħa ta' plaċebo (n = 581, popolazzjoni analizzata indipendentement; medjan ta' 4.0 xhur u 2.0 xhur, rispettivament) (hazard ratio = 0.60, 95%CI = 0.49-0.73,p < 0.00001).Analiżi
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR=0.78; 95 % CI = 0 .61-1.00, p=0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n=172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95 % CI = 1.08-2.26, p = 0.018).
Maltese: 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: 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 bi pemetrexed , li jirrappreżentaw għallinqas 10 ċikli sħaħ ta' pemetrexed.
English: Trometamol (for pH adjustment) Anhydrous citric acid Methionine
Maltese: Anhydrous citric acid Methionine Ilma ta' l-injezzjonijiet
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
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: Armisarte 25 mg/ml concentrate for solution for infusion pemetrexed
Maltese: Armisarte 25 mg/ml konċentrat għal soluzzjoni għall-infużjoni
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: - Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis - Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) - Hepatitis (inflammation of the liver) - Anaphylactic shock (severe allergic reaction)
Maltese: - Kundizzjonijiet bullożi (mard tal-ġilda b'ħafna nfafet)- li jinkludu s-sindromu ta' Stevens-Johnson u Nekrożi epidermali tossika - Anemija emolitika kkawżata mis-sistema immunitarja tiegħek stess (jinqerdu ċ-ċelluli ħomor taddemm minħabba l-antikorpi)
English: The other ingredients are trometamol (for pH adjustment), anhydrous citric acid, methionine and water for injection.
Maltese: L-ingredjenti l-oħra huma trometamol (għal aġġustament tal-pH), anhydrous citric acid, methionine u ilma ta' l-injezzjonijiet.
English: Table 3 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: TABELLA 3 - Tabella għall-modifikazzjoni fid-doża ta' pemetrexed (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Newrotossiċità
English: 75% of previous dose (both pemetrexed and cisplatin)
Maltese: 75 % tad-doża ta' qabel (kemm pemetrexed kif ukoll cisplatin)
English: There is no relevant use of Armisarte in the paediatric population
Maltese: M'hemm ebda użu rilevanti ta' Armisarte fil-popolazzjoni pedjatrika.
English: When using Armisarte in combination with cisplatin:
Maltese: Meta tuża Armisarte flimkien ma' cisplatin:
English: Pemetrexed in combination with cisplatin The recommended dose of pemetrexed 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' pemetrexed 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: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Maltese: L-Effikaċja ta' pemetrexed + cisplatin vs. gemcitabine + cisplatin fl-linja ta' kura tal-kanċer tal pulmun mhux b'ċelluli żgħar- popolazzjoni ITT u sottogruppi istoloġiċi.
English: 50% of previous dose a
Maltese: 50 % tad-doża ta' qabel
English: Common Taste disturbance Eye disorders Common Conjunctivitis
Maltese: Disturbi fis sistema nervuża Komuni
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
Maltese: * Irreferi għal verżjoni 2 tas-CTC ta' l-Istitut Nazzjonali tal-Kanċer għal kull grad ta' tossiċità.
English: One ml contains 25 mg pemetrexed (as pemetrexed diacid).
Maltese: Kull ml ta' konċentrat fih 25 mg pemetrexed (bħala pemetrexed diacid).
English: The dose of Armisarte is 500 milligrams for every square metre of your body's surface area.
Maltese: Id-doża ta' Armisarte hi 500 milligramma għal kull metru kwadru ta'
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: pemetrexed u ta' 10.6 xhur għall-fergħa tal-plaċebo, hazard ratio= 0.79 (95 %CI = 0.65 - 0.95; p = 0.01192.
English: *P-values <0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Maltese: * Valuri P <0.05 meta tqabbel pemetrexed/cisplatin ma' gemcitabine/cisplatin, permezz tal-Fisher Exact test. ** Irreferi għas-CTC (v 2.0; NCI 1998) ta' l-Istitut Nazzjonali tal-Kanċer għal kull Grad ta' Tossiċità. *** Skont is-CTC (v 2.0; NCI 1998)ta' l-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u l-alopeċja għandhom jiġu rrapportati bħala Grad 1 jew 2 biss.
English: One vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid).
Maltese: Kull kunjett ta' 34 ml konċentrat fih 850 mg pemetrexed (bħala pemetrexed diacid).