FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (< 2% of oral clearance).
Maltese: Fi studju mwettaq f'pazjenti b'mard renali fl-aħħar stadju (ESRD) mogħtija l-emodijalisi, it-tneħħija ta' aliskiren waqt id-dijalisi kien baxx (< 2% tat-tneħħija orali).
English: Over the 12 week period, aliskiren monotherapy lowered systolic/diastolic blood pressure by 14.0/5.1 mmHg, compared to 11.6/3.6 mmHg for ramipril, consistent with aliskiren being non-inferior to ramipril at the dosages chosen and the differences in systolic and diastolic blood pressure were statistically significant.
Maltese: 6/3.6 mmHg għal ramipril, konsistenti b'aliskiren li mhuwiex inferjuri għal ramipril bid-dożi magħżula u d-differenzi fil-pressjoni sistolika u dijastolika tad-demm kienu sinjifikanti statistikament.
English: The RMP shall include: - Deadlines for submission of the APOLLO study results.
Maltese: - Dati ta' skadenza għas-sottomissjoni tar-riżultati tal-istudju APOLLO;
English: Component of a multipack comprising 2 packs, each containing 49 tablets.
Maltese: Jagħmel parti minn pakkett b'ħafna li jkun fih 2 pakketti, kull wieħed ikun fih 49 pillola.
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV).
Maltese: Aliskiren għandu jintuża bil-kawtela f'pazjenti b'insuffiċjenza tal-qalb konġestiva serja (Klassi Funzjonali III-IV ta' l-Assoċjazzjoni Tal-Qalb ta' New York [NYHA]).
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Riprazo 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Maltese: F'pazjenti obeżi li għandhom il-pressjoni għolja li ma wrewx rispons xieraq għal HCTZ 25 mg, kura bl-inklużjoni ta' Riprazo 300 mg ipprovdiet tnaqqis addizzjonali fil-pressjoni tad-demm li seta' jitqabbel ma' kura bl-inklużjoni ta' irbesartan 300 mg jew amlodipine 10 mg.
English: When administered with atorvastatin, steady-state Riprazo AUC and Cmax increased by 50%.
Maltese: Meta ngħata ma' atorvastatin, l-AUC u Cmax fi stat fiss ta' Riprazo żdiedu b'50%.
English: In hypertensive patients, once-daily administration of Riprazo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Maltese: F'pazjenti bil-pressjoni għolja, l-għotja darba kuljum ta' Riprazo b'dożi ta' 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid-doża fil-pressjoni tad-demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta' 24 siegħa ta' l-intervall bejn id-dożi (b'hekk żammew il-benefiċċju ta' kmieni filgħodu) b'medja fil-proporzjon bejn l-ogħla u l-anqas għar-rispons dijastoliku sa' 98% għad-doża ta' 300 mg. 85 sa 90% ta' l-effett massimu li jbaxxi l-pressjoni deher wara ġimgħatejn.
English: Co-administration with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and coadministration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Maltese: L-għoti tiegħu flimkien ma' aliskiren 150 mg wassal għal tnaqqis ta' 61% fl-AUC ta' aliskiren u l-għoti flimkien ma' aliskiren 300 mg wassal għal tnaqqis ta' 38% fl-AUC ta' aliskiren.
English: In post-marketing experience, angioedema or angioedema-like reactions have been reported when aliskiren was co-administered with ACEIs and/or ARBs (see section 4.8).
Maltese: Kienu osservati reazzjonijiet anafilattiċi matul it-trattament b'aliskiren u dan wara li l-prodott tqiegħed fis-suq (ara sezzjoni 4.8).
English: If you think you may be allergic, ask your doctor for advice.
Maltese: Jista' jkollok bżonn attenzjoni medika.
English: The MAH shall submit an updated risk management plan (RMP) that adequately describes all the safety concerns, the pharmacovigilance activities and the interventions designed to identify, characterise, prevent or minimise the risks within a month following the Commission Decision of the renewal procedure (EMEA/H/C/853/R/068).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jippreżenta pjan tal-immaniġġar tar-riskju (RMP) aġġornat li jiddeskrivi b'mod xieraq ittħassib rigward is-sigurtà, l-attivitajiet ta' farmakoviġilazna u l-interventi kollha maħsuba biex ir-riskji kollha jiġu identifikati, ikkaratterizzati, ipprevjenuti jew minimizzati fi żmien xahar mid-Deċiżjoni tal-Kummissjoni dwar il-proċedura ta' tiġdid (EMEA/H/C/853/R/068).
English: Concomitant use of Riprazo with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Maltese: L-użu konkomitanti ta' Riprazo ma' ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: Pregnancy
Maltese: Ġenerali
English: What Riprazo looks like and contents of the pack Riprazo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Maltese: Riprazo 150 mg pilloli miksijin b'rita huma pilloli roża ċar, konvessi miż-żewġ naħat, tondi, ittimbrati ‘IL' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
English: Riprazo 150 mg film-coated tablets
Maltese: Riprazo 150 mg pilloli miksijin b'rita
English: - The concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m 2) (see sections 4.2, 4.4, 4.5 and
Maltese: L-użu ta' aliskiren ma' ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'dijabete mellitus jew b'indeboliment renali (GFR < 60 ml/min/1.73 m2) u mhuwiex rakkomandat f'pazjenti oħra (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: Riprazo 300 mg film-coated tablets
Maltese: Riprazo 300 mg pilloli miksijin b'rita
English: Medicinal products affecting serum potassium levels Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels (e.g. potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, heparin) may lead to increases in serum potassium.
Maltese: Prodotti mediċinali li jaffettwaw livelli ta' potassium fis-serum L-użu flimkien ma' aġenti oħra li jaffettwaw l-RAAS, ta' NSAIDs jew ta' aġenti li jżidu l-livelli ta' potassium fis-serum (eż. dijuretiċi li ma jħallux il-potassium jintilef, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium, heparin) jista' jwassal għal żidied tal-potassium fis-serum.
English: No additional blood pressure lowering effect was detected with 300 mg aliskiren compared to 150 mg aliskiren.
Maltese: Ma deher l-ebda effett ta' tnaqqis ieħor fil-pressjoni tad-demm meta ngħataw 300 mg aliskiren imqabbel ma' 150 mg aliskiren.
English: However, as with other medicinal products acting on the renin-angiotensin system, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Maltese: Madankollu, kif jiġri bi prodotti medċinali oħra li jaħdmu fuq is-sistema tar-renin-angiotensin, hemm żieda fir-riskju ta' insuffiċjenza tal-kliewi, inkluż indeboliment akut tal-kiewi, meta l-pazjenti bi stenożi tal-arterja renali jiġu kkurati b'aliskiren.
English: Concomitant use of Riprazo with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see
Maltese: L-użu konkomitanti ta' Riprazo ma' ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjoni
English: Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side.
Maltese: Pillola miksija b'rita Pillola roża ċar, konvessa miż-żewġ naħat, tonda, ittimbrata ‘IL' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
English: Compared to a diuretic (hydrochlorothiazideHCTZ), Riprazo 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Maltese: Matul medda ta' 12-il ġimgħa, ilmonoterapija b'aliskiren naqqset il-pressjoni sistolika/dijastolika tad-demm b'14.0/5.1 mmHg, meta mqabbel mal-11.
English: Pregnancy and breast-feeding
Maltese: Meraq tal-grejpfruit
English: You should not take this medicine together with grapefruit juice.
Maltese: M'ghandekx tieħu din il-mediċina mal-meraq tal-grejpfrut.
English: As with other medicinal products acting on the renin-angiotensin system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
Maltese: Bħal bi prodotti mediċinali oħra li jaħdmu fuq is-sistema tar-renin -angiotensin, anġjoedima jew sintomi li jissuġġerixxu anġjoedima (nefħa fil-wiċċ, fix-xofftejn, filgerżuma u/jew fl-ilsien) kienu rrappurtati f'pazjenti kkurati b'aliskiren.
English: The primary endpoint was a composite of cardiovascular and renal complications.
Maltese: Ittragward finali primarju kien taħlita ta' kumplikazzjonijiet kardjovaskulari u renali.
English: Relative AUC and Cmax of aliskiren in subjects with renal impairment ranged between 0.8 to 2 times the levels in healthy subjects following single dose administration and at steady state.
Maltese: AUC u Cmax relattivi ta' aliskiren f'individwi b'indeboliment renali kellhom medda ta' bejn 0.8 sa darbtejn il-livelli f'individwi b'saħħithom wara li ngħatat doża waħda u fi stat fiss.
English: The use of aliskiren in combination with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Maltese: L-użu konkomitanti ta' aliskiren ma' ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'dijabete mellitus jew b'indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: Packs containing 98 (2x49) or 280 (20x14) tablets are multi-packs.
Maltese: Pakketti li jkun fihom 98 (2x49) jew 280 (20x14) pillola huma pakketti b'ħafna.
English: Aliskiren belongs to a class of medicines called renin inhibitors.
Maltese: Aliskiren jagħmel parti minn klassi ta' mediċini li jissejjħu inibituri ta' renin.
English: Check with your doctor or pharmacist
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Administration of a single oral dose of 300 mg aliskiren was associated with very minor changes in the pharmacokinetics of aliskiren (change in Cmax of less than 1.2 fold; increase in AUC of up to 1.6 fold) compared to matched healthy subjects.
Maltese: L-għoti ta' doża waħda ta' 300 mg aliskiren kienet assoċjata ma' tibdiliet baxxi talfarmakokinetiċi ta' aliskiren (bidla fis-Cmax ta' anqas minn 1.2 drabi; żieda fil-AUC sa 1.6 drabi) mqabbel ta' pazjenti b'saħħithom imlaqqgħin.
English: - verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat angina pectoris.
Maltese: - verapamil, mediċina li tintuża biex tbaxxi l-pressjoni għolja, biex tirranġa r-ritmu tal-qalb jew għall-kura ta' anġina pectoris.
English: Treatment of essential hypertension in adults.
Maltese: Kura ta' pressjoni għolja naturali fl-adulti.
English: Package leaflet: information for the user
Maltese: Sorsi oħra ta' informazzjoni
English: The change in plasma levels of aliskiren in the presence of ketoconazole or verapamil is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical trials.
Maltese: Il-bidla fil-livelli tal-plażma ta' aliskiren filpreżenza ta' ketoconazole jew verapamil hija mistennija li tkun fil-medda li tintlaħaq li kieku d-doża ta' aliskiren kellha tiġi rduppjata; id-dożi ta' aliskiren ta' mhux aktar minn 600 mg, jew darbtejn logħla d-doża terapewtika rakkomandata, instabu li jkunu ttollerati sewwa fi provi kliniċi kkontrollati.
English: No controlled clinical data are available on the use of Riprazo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Maltese: M'hemmx tagħrif kliniku kkontrollat dwar l-użu ta' Riprazo f'pazjenti bi stenożi tal-arterja renali unilaterali jew bilaterali, jew fi stenożi f'kilwa waħda.
English: What Riprazo looks like and contents of the pack Riprazo 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Maltese: Riprazo 300 mg pilloli miksijin b'rita huma pilloli aħmar ċar, konvessi miż-żewġ naħat, f'għamla ovali, ittimbrati ‘IU' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
English: Increases in serum potassium have been observed with aliskiren in post-marketing experience and these may be exacerbated by concomitant use of other agents acting on the RAAS or by non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Żidiet tal-potassium fis-serum ġew osservati b'aliskiren wara l-esperjenza ta' wara t-tqegħid fis-suq u dawn jistgħu jiħraxu bl-użu konkomitanti ta' sustanzi oħra li jaġixxu fuq RAAS jew ta' mediċini antinfjammatorji mhux sterojdi (NSAIDs).
English: Component of a multipack comprising 20 packs, each containing 14 tablets.
Maltese: Jagħmel parti minn pakkett b'ħafna li jkun fih 20 pakkett, kull wieħed ikun fih 14-il pillola.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see other P-gp references in section 4.5).
Maltese: Madankollu, inibituri ta' CYP3A4 ta' spiss jeffettwaw ukoll P-gp. Żieda fl-esponiment għal aliskiren waqt l-għotja fl-istess ħin ta' inibituri ta' CYP3A4 li jimpedixxu wkoll P-gp tista' għalhekk tkun mistennija (ara referenzi oћra ghal P-gp f'sezzjoni 4.5).
English: EU/2/08/088/004 Acticam 5 mg/ml solution for injection
Maltese: EU/2/08/088/004 Acticam 5 mg/ml Soluzzjoni għall-injezzjoni
English: Glass vial
Maltese: Perjodu ta' Tiżmim
English: Packaging Content Package size
Maltese: Mhux applikabbli.
English: Target species Route of administration
Maltese: Speċi li fuqhom għandu jintuża lprodott
English: Dogs and cats sc/iv
Maltese: Kunjett ta' linjezzjoni (ħġieġ)
English: Fresenius Kabi Polska Sp. z o.o.
Maltese: Fresenius Kabi Polska Sp. z o.o. ul.
English: Sienkiewicza 25, Kutno, 99-300, Poland
Maltese: Sienkiewicza 25, 99-300 Kutno
English: The overall response rate was 14.1 %.
Maltese: Il-rata ta' respons globali kienet ta'14.1%.
English: Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Maltese: Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF
English: Dose for cisplatin (mg/m
Maltese: Doża ta' cisplatin (mg/m
English: ≥ 100,000 cells/mm
Maltese: jkun ≥ 100,000 ċellula/mm
English: Dose of pemetrexed (mg/m
Maltese: Doża ta' pemetrexed (mg/m
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be ≤ 3 times upper limit of normal.
Maltese: L- alkaline phosphatase (AP), l- aspartate aminotransferase (AST jew SGOT) u l- alanine aminotransferase (ALT jew SGPT) għandhom ikunu ≤ 3 darbiet il-limitu massimu tan-normal.
English: Excipients: Mannitol, hydrochloric acid concentrated, trometamol
Maltese: Eċċipjenti: Mannitol, hydrochloric acid ikkonċentrat, trometamol
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Maltese: Effikaċja ta' pemetrexed vs docetaxel f'popolazzjoni ITT - NSCLC pemetrexed
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 July 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 lulju 2016
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Maltese: Ġew evalwati wkoll lanaliżi ta' sensittività ta' endpoints ta' effikaċja primarja fil-popolazzjoni Kwalifikata b'Protokoll (PQ).
English: The recommended dose of cisplatin is 75 mg/m
Maltese: Id-doża rakkomandata ta' cisplatin hi ta' 75 mg/m
English: Hydrochloric acid concentrated (E507) (pH adjustment) Trometamol (pH adjustment)
Maltese: Hydrochloric acid, ikkonċentrat (E507) (aġġustament ta' pH) Trometamol (aġġustament ta' pH)
English: The pH of the reconstituted solution is between 6.6 and 7.8.
Maltese: IlpH tas-soluzzjoni rikostitwita hi bejn 6.6 u 7.8.
English: National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: Kriterji ta' Tossiċità Komuni ta' l-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998)
English: The percentage of patients that received post study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Maltese: Ilpersentaġġ ta' pazjenti li rċevew kura wara l- istudju kien ta' 64.3% għal pemetrexed u 71.7% għal plaċebo.
English: Common SGPT (ALT) elevation
Maltese: Żieda fl-SGPT (ALT)
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, analogi ta' folic acid, Kodiċi ATC:
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: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari(jistgħu jaffettwaw sa 1 minn kull 1,000 persuna)
English: Frequency estimate: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <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: Komuni ħafna ( > 1/10 ), Komuni ( > 1/100 sa < 1/10), Mhux komuni ( > 1/1,000 sa < 1/100), Rari ( > 1/10,000 sa < 1/1,000), Rari ħafna (≤ 1/10,000) u mhijiex magħrufa (ma tistax tiġi stimata mit tagħrif li hemm disponibbli).
English: 50 % of previous dose a
Maltese: 50 % tad-doża ta' qabel a
English: Overall response rate** (95% CI)
Maltese: Ir-rata ta' rispons globali** (95 % CI)
English: Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Maltese: Avvenimenti li dehru b'mod rari jinkludu s-sindromu ta' Stevens- Johnson u Toxic epidermal necrolysis.
English: Lot 14.
Maltese: B12.
English: Survival time (months) ▪ Median (m) ▪ 95% CI for median ▪ HR ▪ 95% CI for HR ▪ Non-inferiority p-value (HR)
Maltese: ▪ Medjan (m) ▪ 95 % CI għal medjan ▪ HR ▪ 95 % CI għal HR ▪ Il-valur-P (HR) mhux inferjuri
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%, > 6cycles: 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: NSCLC, maintenance treatment
Maltese: NSCLC, kura ta' manteniment
English: In vitro studies indicate that pemetrexed is approximately 81 % bound to plasma proteins.
Maltese: Studji in vitro jindikaw li madwar 81% ta' pemetrexed jintrabat mal-proteini talplażma.
English: CTC
Maltese: ANC
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of medicinal product metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Maltese: Studji in vitro b'mikrożomi tal-fwied umani juru li mhux previst li pemetrexed jikkawża l-inibizzjoni klinikament sinifikanti tat-tneħħija metabolika ta' prodotti mediċinali li jkunu metabolizzati b'CYP3A, CYP2D6, CYP2C9, u CYP1A2.
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 Pemetrexed Fresenius Kabi.
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 ittrattament b'Pemetrexed Fresenius Kabi.
English: Patients also required lower administration of erythropoietin/darbopoietin (10.4% versus 18.1%, p<0.001), G-CSF/GM-CSF (3.1% versus 6.1%, p=0.004), and iron preparations (4.3% versus 7.0%, p=0.021).
Maltese: Il-pazjenti kellhom bżonn ukoll ta' anqas għotjiet ta' erythropoietin/darbopoietin (10.4% kontra 18.1%, p<0.001), G-CSF/GM-CSF (3.1% kontra 6.1%, p=0.004), u preparazzjonijiet ta' ħadid (4.3% kontra 7.0%, p=0.021).
English: SGOT (AST) elevation
Maltese: Żieda fl-SGOT (AST)
English: Nausea Anorexia
Maltese: Tqallih Anoressija
English: Common Rash/desquamation 6.6
Maltese: Rimettar Mukosite/stomatite 6.8
English: A total of 213 patients (48.3%) completed ≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with pemetrexed.
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'pemetrexed.
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 l- half-life ta' l-eliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni talkliewi normali (tneħħija tal-krejatinina ta' 90 ml/min).
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI = 0.84-1.05).
Maltese: Studju ta' Fażi 3, open-label, randomised, magħmul f'ħafna ċentri b'pemetrexed flimkien ma' cisplatin kontra gemcitabine flimkien ma' cisplatin f'pazjenti b'kanċer tal-pulmun mhux b'ċelluli żgħar (NSCLC) lokalment avanzat jew metastatiku (Stadju IIIb jew IV) u li qatt ma ħadu ebda kimoterapija, wera li pemetrexed flimkien ma' cisplatin (popolazzjoni bl-Intenzjoni Li Tikkura (ITT) n = 862) laħaq l- endpoint primarju u wera effikaċja klinika simili għal gemcitabine flimkien ma' cisplatin (ITT n=863) fis-sopravivenza totali (proporzjon aġġustat ta' riskju 0.94; 95% CI = 0.84-1.05).
English: Response (n: qualified for response) ▪ Response rate (%) (95% CI) ▪ Stable disease (%)
Maltese: ▪ Persentaġġ ta' respons (%) (95 % CI) ▪ marda stabbli(%)
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 = 0.941.15), 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 Fresenius Kabi 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed diacid).
Maltese: Pemetrexed Fresenius Kabi 100 mg: Kull kunjett fih 100 milligramm ta' pemetrexed (bħala pemetrexed diacid).
English: Common Pain Edema 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 oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Maltese: SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.