FrancophonIA/ELRC3.0 huggingface dataset:
English: Papendorpseweg 83 3528 BJ Utrecht
Maltese: Eli Lilly Nederland B.V. Papendorpseweg 83 3528 BJ Utrecht L-Olanda
English: Branchburg New Jersey NJ 08876
Maltese: ImClone Systems LLC 33 ImClone Drive, Branchburg New Jersey NJ 08876
English: Hypokalaemiaa,b Hyponatraemiaa Hypoalbuminaemiaa
Maltese: Ipokalimjaa,b Iponatrimjaa Ipoalbuminimjaa
English: Store in a refrigerator (2 ºC - 8 ºC).
Maltese: Aħżen fi friġġ (2 ºC - 8 ºC ).
English: No liver metastases: ALT/AST ≤3 x ULN Liver metastases: ALT/AST ≤5 x ULN
Maltese: ALT/AST ≤3 x ULN
English: The ECOG PS was 1 for 72% of patients.
Maltese: Il-PS ta' ECOG kien 1 għal 72% tal-pazjenti.
English: c Based on study REACH-2 and REACH (single-agent ramucirumab in HCC).
Maltese: c Skont l-istudju REACH-2 u REACH (ramucirumab bħala sustanza waħidha f'HCC).
English: In 32 of the 33 pre-specified sub-group analyses for OS, the HR was < 1.0.
Maltese: Fi 32 mit-33 analiżi speċifikati minn qabel ta' sottogruppi għal OS, l-HR kien < 1.0.
English: Table 4: FOLFIRI dose reductions FOLFIRI componenta
Maltese: Tabella 4: Tnaqqis fid-dożi ta' FOLFIRI
English: gemcitabine (25%), taxane (24%), and bevacizumab (14%); 22% of patients received prior maintenance therapy.
Maltese: L-aktar terapiji komuni li ngħataw qabel kienu jinkludu pemetrexed (38%), gemcitabine (25%), taxane (24%), u bevacizumab (14%); 22% tal-pazjenti rċevew terapija ta' manteniment qabel.
English: A relevant exposure-efficacy association was observed for ramucirumab in REACH-2 (see section 5.2).
Maltese: Assoċjazzjoni rilevanti ta' espożizzjoni-effikaċja ġiet osservata għal ramucirumab f'REACH-2 (ara sezzjoni 5.2).
English: Non-small cell lung cancer (NSCLC)
Maltese: Kanċer tal-pulmun mhux b'ċelluli żgħar (NSCLC - Non-small cell lung cancer)
English: Ramucirumab has not been studied in patients with severe hepatic impairment (total bilirubin >3.0 ULN and any AST).
Maltese: Ramucirumab ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (bilirubin totali >3.0 ULN u kwalunkwe AST).
English: h Includes cases of nephrotic syndrome.
Maltese: h Jinkludi każijiet ta' sindromu nefrotiku.
English: Includes: anal haemorrhage, diarrhoea haemorrhage, gastric haemorrhage, gastrointestinal haemorrhage, haematemesis, haematochezia, haemorrhoidal haemorrhage, Mallory-Weiss syndrome, melaena, oesophageal haemorrhage, rectal haemorrhage, and upper gastrointestinal haemorrhage.
Maltese: Jinkludi emorraġija anali, emorraġija bid-dijarea, emorraġija gastrika, emorraġija gastrointestinali, ematemeżi, ematokeżja, emorraġija emarrojdali, sindromu Mallory-Weiss, melena,
English: Placebo N=117
Maltese: N=117
English: Arterial thromboembolic events
Maltese: Avvenimenti tromboemboliċi arterjalia
English: Clinically relevant reactions (including Grade ≥3) associated with antiangiogenic therapy observed in ramucirumab-treated patients across clinical studies were: gastrointestinal perforations, infusionrelated reactions and proteinuria (see sections 4.2 and 4.4).
Maltese: Reazzjonijiet rilevanti b'mod kliniku (inkluż ta' Grad ≥ 3) assoċjati ma' terapija antianġjoġenika li ġew osservati f'pazjenti kkurati b'ramucirumab fl-istudji kliniċi kollha kienu: peforazzjonijiet gastrointestinali, reazzjonijiet marbuta mal-infużjoni u proteinurja (ara sezzjonijiet 4.2 u 4.4).
English: Abbreviations: CI = confidence interval, CR= complete response, PR= partial response, CMH= Cochran-Mantel-Haenszel
Maltese: CI = intervall ta' kunfidenza (confidence interval), CR= rispons sħiħ (complete response), PR= rispons parzjali (partial response), CMH= Cochran-Mantel-Haenszel
English: Stratified CMH p-value
Maltese: Valur p CMH stratifikat
English: Cyramza is a cancer medicine that contains the active substance ramucirumab, which is a monoclonal antibody.
Maltese: Cyramza huwa mediċina kontra l-kanċer li fih is-sustanza attiva ramucirumab, li huwa antikorp monoklonali.
English: Table 11: Summary of efficacy data - ITT population Cyramza plus docetaxel N=628
Maltese: Tabella 11: Sommarju tad-dejta ta' effikaċja - popolazzjoni ITT Cyramza u docetaxel N=628
English: Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
Maltese: Cyramza, flimkien ma' FOLFIRI (irinotecan, folinic acid, u 5-fluorouracil), huwa indikat għat trattament ta' pazjenti adulti b'kanċer kolorektali metastatiku (mCRC - metastatic colorectal cancer) bi progressjoni tal-marda waqt jew wara terapija preċedenti b'bevacizumab, oxaliplatin u wieħed mill fluoropyrimidines.
English: Based on population pharmacokinetic approach (PopPK), the mean (% coefficient of variation [CV%]) volume of distribution at steady state for ramucirumab was 5.4L (15%).
Maltese: Abbażi tal-metodu farmakokinetiku tal-popolazzjoni PK (PopPK - population pharmacokinetics), ilmedja (% tal-koeffiċjent ta' varjazzjoni [CV% - % coefficient of variation]) tal-volum ta' distribuzzjoni fl-istat fiss (steady state) għal ramucirumab kienet 5.4 L (15%).
English: Hepatic encephalopathyc
Maltese: Enkefalopatija epatikac
English: ADRs are listed below by MedDRA body system organ class.
Maltese: L-ADRs huma elenkati hawn taħt skont is-sistema ta' klassifika tal-organi MedDRA.
English: A minimal grade of inflammation and/or mononuclear cell infiltration was seen in several organs.
Maltese: Grad minimu ta' infjammazzjoni u/jew infiltrazzjoni ta'ċelluli mononukleari deheret f'diversi organi.
English: Cyramza may cause changes in laboratory tests.
Maltese: Cyramza jista' jikkawża tibdil fir-riżultati ta' testijiet tal-laboratorju.
English: Intestinal obstructiona
Maltese: Ostruzzjoni intestinalia
English: Fistula
Maltese: Fistla
English: Aspirin use at doses up to 325 mg/day was permitted (see section 5.1).
Maltese: L-użu ta' aspirina f'dożi sa 325 mg/jum kien permess (ara sezzjoni 5.1).
English: Table 10: Summary of efficacy data - ITT population Cyramza plus FOLFIRI N=536
Maltese: Sommarju tad-dejta ta' effikaċja- Popolazzjoni ITT Cyramza u FOLFIRI N=536
English: Based on PopPK, the following covariates were found to have no impact on ramucirumab disposition: age, sex, race, albumin levels.
Maltese: ramucirumab: età, sess, razza, livelli ta' albumina.
English: Pack of 1 vial of 50 ml.
Maltese: Pakkett ta' kunjett wieħed ta' 50 ml.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC21.
Maltese: Sustanzi antineoplastiċi, antkorpi monoklonali Kodiċi ATC:
English: For recurrent Grade 2 stomatitis, reduce by 2 dose levels for 5-FU.
Maltese: Għal stomatite ta' Grad 2 rikurrenti, naqqas id-doża ta' 5-FU b'2 livelli.
English: There are limited safety data available for patients with severe renal impairment (creatinine clearance 15 to 29 ml/min) treated with ramucirumab (see sections 4.2 and 5.2).
Maltese: Hemm dejta limitata dwar sigurtà għal pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina minn 15 sa 29 ml/min) ikkurati b'ramucirumab (ara sezzjonijiet 4.2 u 5.2).
English: The final total volume in the container should be 250 ml.
Maltese: Il-volum totali finali fil-kontenitur għandu jkun ta' 250 ml.
English: Pack of 2 vials of 10 ml.
Maltese: Pakkett ta' 2 kunjetti ta' 10 ml.
English: - The other ingredients are histidine, histidine monohydrochloride, sodium chloride, glycine (E640), polysorbate 80 (E433) and water for injections (see section 2 “Cyramza contains sodium”).
Maltese: - Is-sustanzi l-oħra huma histidine, histidine monohydrochloride, sodium chloride, glycine (E640), polysorbate 80 (E433) u ilma għall-injezzjonijiet (ara sezzjoni 2 “Cyramza fih sodium”).
English: Pulmonary haemorrhage in NSCLC
Maltese: Emorraġija mill-pulmuni f'NSCLC
English: The FOLFIRI regimen was: irinotecan 180 mg/m2 administered over 90 minutes and folinic acid 400 mg/m2 administered, simultaneously over 120 minutes; followed by bolus 5-fluorouracil(5-FU) 400 mg/m2 over 2 to 4 minutes; followed by 5-FU 2400 mg/m2 administered by continuous infusion over 46 to 48 hours.
Maltese: L-iskeda ta' għoti ta' FOLFIRI kienet: 180 mg/m2 irinotecan mogħti fuq perjodu ta' 90 minuta u 400 mg/m2 folinic acid mogħti, fl-istess ħin fuq perjodu ta' 120 minuta; segwit minn 400 mg/m2
English: Spontaneous development of fistula (see section 4.4).
Maltese: Żvilupp spontanju ta' fistla (ara sezzjoni 4.4).
English: 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)
Maltese: Rari (≥1/10,000 sa <1/1,000)
English: In the pivotal studies there is limited evidence that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Maltese: Fl-istudji prinċipali kien hemm evidenza limitata li pazjenti li għandhom 65 sena jew aktar qegħdin f'riskju akbar ta' każijiet avversi meta mqabbla ma' pazjenti li għandhom inqas minn 65 sena.
English: The primary endpoint was overall survival (OS) and the secondary endpoints included progression free survival (PFS) and overall response rate (ORR).
Maltese: Il-punt finali primarju kien sopravivenza totali (OS - overall survival) u l-punti finali sekondarji kienu jinkludu sopravivenza mingħajr progressjoni (PFS - progression free survival) u rata ta' rispons totali (ORR - overall response rate).
English: Rasha
Maltese: Raxxa
English: Patients were randomised in a 1:1 ratio to receive Cyramza plus paclitaxel (n=330) or placebo plus paclitaxel (n=335).
Maltese: Il-pazjenti ntgħażlu b'mod arbitrarju fi proporzjon ta' 1:1 biex jirċievu Cyramza u paclitaxel (n=330) jew plaċebo u paclitaxel (n=335).
English: Based on PopPK, ramucirumab exposure in patients with mild hepatic impairment (total bilirubin >1.0-1.5 upper limit of normal (ULN) and any AST or total bilirubin ≤1.0 ULN and AST >ULN) or moderate hepatic impairment (total bilirubin > 1.5-3.0 ULN and any AST) was similar to patients with normal hepatic function (total bilirubin and AST ≤ ULN).
Maltese: Abbażi ta' PopPK, espożizzjoni għal ramucirumab f'pazjenti b'indeboliment ħafif tal-fwied (bilirubin totali >1.0-1.5 limitu ta' fuq tan-normal (ULN - upper limit of normal) u kwalunkwe AST jew bilirubin totali ≤1.0 ULN u AST >ULN) jew indeboliment moderat tal-fwied (bilirubin totali > 1.5-3.0 ULN u kwalunkwe AST) kien jixbah lil dak ta' pazjenti b'funzjoni normali tal-fwied (bilirubin totali u AST ≤ ULN).
English: Each 10 ml vial contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Maltese: Kull kunjett ta' 10 ml fih inqas minn mmol 1 ta' sodium (23 mg), jiġifieri tista' tgħid li huwa essenzjalment ‘nieqes mis-sodium'.
English: Gastrointestinal perforationa
Maltese: Perforazzjoni gastrointestinalia
English: Post discontinuation systemic anticancer therapy was given to 54% of patients receiving Cyramza plus FOLFIRI and 56% of patients receiving placebo plus FOLFIRI.
Maltese: Terapija sistemika kontra l-kanċer wara t-twaqqif ingħatat lil 54% tal pazjenti li kienu qed jirċievu Cyramza u FOLFIRI u 56% tal-pazjenti li kienu qed jirċievu plaċebo u
English: ≤ Grade 1 (National Cancer Institute Common
Maltese: ≤ Grad 1 (Kriterji tal-Istitut Nazzjonali tal
English: Odd ratio
Maltese: TAGĦRIF
English: 5-FU and irinotecan.
Maltese: 5-FU u irinotecan b'livell 1.
English: Pre-specified subgroup analyses for both PFS and OS according to age (<65 and ≥65 years), gender, race, ECOG PS (0 or ≥1), number of organs involved, liver metastases only, site of primary tumour (colon or rectum), carcinoembryonic antigen levels (<200 μg/L, ≥200 μg/L), all showed a treatment effect favouring Cyramza plus
Maltese: (<65 u ≥65 sena), is-sess tal-persuna, ir-razza, il-PS ta' ECOG (0 jew ≥1), in-numru ta' organi involuti, metastasi fil-fwied biss, post tat-tumur primarju (kolon jew rektum), livelli ta' antiġen karċinoembrijoniku (<200 μg/L, ≥200 μg/L), ilkoll urew effett tat-trattament favur it-trattament b'Cyramza u FOLFIRI aktar minn plaċebo u FOLFIRI.
English: Samples were tested from 956 patients: 527 ramucirumab treated patients and 429 control treated patients.
Maltese: Il-kampjuni ġew ittestjati mingħand 956 pazjent: 527 pazjent ikkurat b'ramucirumab u 429 pazjent ikkurati b'kontroll.
English: Each 50 ml vial contains approximately 85 mg sodium.
Maltese: Kull kunjett ta' 50 ml fih madwar 85 mg sodium.
English: The ORR was similar for both treatment arms (13.4% versus 12.5%, ramucirumab plus FOLFIRI versus placebo plus FOLFIRI, respectively).
Maltese: 12.5%, ramucirumab u FOLFIRI versus plaċebo u FOLFIRI, rispettivament).
English: - have severe kidney problems.
Maltese: - għandek problemi severi bil-kliewi.
English: 500 mg/50 ml
Maltese: INDIVIDWALI 500 mg/50 ml
English: Gastric cancer and gastro-oesophageal junction (GEJ) adenocarcinoma
Maltese: Kanċer tal-istonku u adenokarċinoma fl-għaqda gastro-esofaġali (GEJ - gastro-oesophageal junction) Cyramza flimkien ma' paclitaxel
English: ADRs of haemangioma and thrombotic microangiopathy were reported in ramucirumab clinical trials at a frequency of common (1.5%) and rare (0.03%), respectively, and through post-marketing reporting.
Maltese: Reazzjonijiet avversi minn sorsi oħra Ġew irrapportati ADRs ta' emanġjoma u mikroanġjopatija trombotika f'provi kliniċi b'ramucirumab b'frekwenza ta' komuni (1.5 %) u rari (0.03 %), rispettivament, u minn rappurtar wara li l-prodott tqiegħed fis-suq.
English: Based on PopPK, ramucirumab exposure was similar in patients with mild renal impairment (creatinine clearance [CrCl] ≥60 to <90 ml/min), moderate renal impairment (CrCl ≥30 to <60 ml/min) or severe renal impairment (CrCl 15 to 29 ml/min) as compared to patients with normal renal function (CrCl ≥90 ml/min).
Maltese: < 90 ml/min), indeboliment moderat tal-kliewi (CrCl ≥ 30 sa <60 ml/min) jew indeboliment sever talkliewi (CrCl 15 sa 29 ml/min) meta mqabbla ma' dik ta' pazjenti b'funzjoni normali tal-kliewi (CrCl ≥90 ml/min).
English: Gastrointestinal perforations (see section 4.4).
Maltese: Perforazzjonijiet gastrointestinali (ara sezzjoni 4.4).
English: In the RAISE study, in mCRC patients treated with ramucirumab plus FOLFIRI, the most frequent (≥1%) ADR that led to the discontinuation of ramucirumab was proteinuria (1.5%).
Maltese: Fl-istudju RAISE, f'pazjenti mCRC ttrattati b'ramucirumab u FOLFIRI, l-aktar ADR frekwenti (≥1%) li wassal għat-twaqqif ta' ramucirumab kien proteinuria (1.5%).
English: Median age was 62 years and 40% of patients were ≥65 years; 57% of patients were male; 76% were White and 20% Asian; 49% had ECOG PS 0; 49% of patients had KRAS mutant tumours; and 24% of patients had TTP <6 months after commencing first-line treatment.
Maltese: Il-medjan tal-età kien 62 sena u 40% tal-pazjenti kellhom ≥65 sena; 57% tal-pazjenti kienu rġiel; 76% kienu Bojod u 20% kienu Asjatiċi; 49% kellhom PS ta' ECOG ta' 0; 49% tal-pazjenti kellhom tumuri b'mutazzjoni fi KRAS; u 24% tal-pazjenti kellhom TTP <6 xhur wara li bdew ittrattament tal-ewwel faxx.
English: Posology adjustments for ramucirumab
Maltese: Aġġustamenti fil-pożoloġija għal ramucirumab
English: ORR % (95% CI) p-value Abbreviations: CI = confidence interval, CR = complete response, ORR = objective response rate and PR = partial response
Maltese: CI = interval ta' kunfidenza (confidence interval), CR = rispons komplet (complete response), ORR = rata ta' rispons oġġettiv (objective response rate) u PR = rispons parzjali (partial response)
English: Ramucirumab is a human receptor-targeted antibody that specifically binds VEGF Receptor 2 and blocks binding of VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand stimulated activation of VEGF Receptor 2 and its downstream signalling components, including p44/p42 mitogen-activated protein kinases, neutralising ligand-induced proliferation and migration of human endothelial cells.
Maltese: B'riżultat ta' dan, ramucirumab jinibixxi attivazzjoni tarriċettur 2 ta' VEGF stimulata minn ligand u l-komponenti tiegħu li jagħtu sinjali biex jattivaw proċessi aktar l-isfel fir-rotta, inklużi kinases tal-proteina p44/p42 attivati minn mitogen, u b'hekk jinnewtralizza proliferazzjoni indotta minn ligand u migrazzjoni ta' ċelluli tal-endotelju tal-bniedem.
English: Eli Lilly Lietuva
Maltese: Eli Lilly Lietuva Tel.
English: Neutropeniaa Leukopeniaa,c Thrombocytopeniaa
Maltese: Newtropenijaa Lewkopenijaa,c
English: A total of 1072 patients were randomised (1:1) to receive either Cyramza (n=536) at 8 mg/kg or placebo (n=536), in combination with FOLFIRI.
Maltese: Total ta' 1,072 pazjent intgħażlu b'mod arbitrarju (1:1) biex jew jirċievu Cyramza (n=536) bid-doża ta' 8 mg/kg jew plaċebo (n=536), flimkien ma' FOLFIRI.
English: Other medicines and Cyramza
Maltese: Mediċini oħra u Cyramza
English: The remainder (25%) received prior platinum and fluoropyrimidine combination therapy with anthracycline.
Maltese: Il-kumplament (25%) kienu rċivew terapija qabel bi platinum flimkien ma' fluoropyrimidine u ma' anthracycline.
English: Efficacy
Maltese: RESPONSABBLI
English: RAINBOW
Maltese: OĦRAJN
English: A trend towards less efficacy with increasing age has been observed in patients receiving ramucirumab plus docetaxel for the treatment of advanced NSCLC with disease progression after platinum-based chemotherapy (see section 5.1).
Maltese: Ġiet osservata tendenza ta' tnaqqis fl-effikaċja b'żieda fl-età f'pazjenti li kienu qed jirċievu ramucirumab u docetaxel għat-trattament ta' NSCLC avvanzat bi progressjoni tal-marda wara kimoterapija abbażi tal-platinum (ara sezzjoni 5.1).
English: Objective response rate [ORR(complete response [CR] + partial response [PR])] was significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (Odds ratio 2.140; 95% CI: 1.499 to 3.160; p=0.0001).
Maltese: Ir-rata oġġettiva ta' rispons[ORR (rispons sħiħ [CR - complete response] + rispons parzjali [PR - partial response]) tjieb b'mod sinifikanti f'pazjenti li kienu qed jirċievu Cyramza u paclitaxel meta mqabbla ma' dawk li kienu qed jirċievu plaċebo u paclitaxel (Proporzjon ta' probabbiltà (Odds Ratio) 2.140; 95% CI: 1.499 sa 3.160; p=0.0001).
English: A consistent improvement (ramucirumab plus docetaxel vs placebo plus docetaxel) was observed in important subgroups for PFS and OS. OS subgroup results included the following: non-squamous histology (HR 0.83; 95% CI: 0.71 to 0.97; median OS [mOS]: 11.1 vs 9.7 months) and squamous histology (HR 0.88; 95% CI: 0.69 to 1.13; mOS: 9.5 vs 8.2 months); patients with prior maintenance (HR 0.69; 95% CI: 0.51 to 0.93; mOS: 14.4 vs 10.4 months); time since start of prior therapy <9 months (HR 0.75; 95% CI: 0.64 to 0.88; mOS: 9.3 vs 7.0 months); patients <65 years old (HR 0.74, 95% CI: 0.62, 0.87; mOS: 11.3 vs 8.9 months).
Maltese: Ir-riżultati tas-sottogruppi ta' OS kienu jinkludu li ġej: istoloġija mhux skwamuza (HR 0.83; 95% CI: 0.71 sa 0.97; OS medjan [mOS]: 11.1 vs 9.7 xhur) u istoloġija skwamuża (HR 0.88; 95% CI: 0.69 sa 1.13; mOS: 9.5 vs 8.2 xhur); pazjenti b'manteniment qabel (HR 0.69; 95% CI: 0.51 sa 0.93; mOS: 14.4 vs 10.
English: 11% of patients treated with Cyramza and 6% of patients on placebo discontinued therapy due to adverse events.
Maltese: 11 % tal-pazjenti kkurati b'Cyramza u 6% tal-pazjenti fuq plaċebo waqqfu t-terapija minħabba każijiet avversi.
English: Chemical and physical in-use stability of Cyramza in sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 24 hours at 2 ºC to 8 ºC or for 4 hours at 25 ºC.
Maltese: L-istabbiltà kimika u fiżika ta' Cyramza waqt l-użu f'soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%) intweriet għal 24 siegħa f'temperatura ta' 2 ºC sa 8 ºC jew għal 4 sigħat f'temperatura ta' 25 ºC.
English: 5-FU infusion 2,400 mg/m2 over 46-48 hours
Maltese: Infużjoni ta' 5-FU 2,400 mg/m2
English: Tel. + 49-(0) 6172 273 2222
Maltese: Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222
English: Severe bleeding: NCI CTCAE Grade 3 or 4 bleeding (see section 4.4).
Maltese: Fsada ta' Grad 3 jew 4 ta' NCI CTCAE (ara sezzjoni 4.4).
English: Ramucirumab is an antiangiogenic therapy and may increase the risk of gastrointestinal perforations.
Maltese: Perforazzjonijiet gastrointestinali Ramucirumab huwa terapija antianġjoġenika u jista' jżid ir-riskju ta' perforazzjonijiet gastrointestinali.
English: 100 mg/10 ml
Maltese: INDIVIDWALI 100 mg/10 ml
English: The most frequent (≥1%) ADRs leading to discontinuation of one or more components of FOLFIRI were: neutropenia
Maltese: (≥1%) li wasslu għat-twaqqif ta' komponent wieħed jew aktar ta' FOLFIRI kienu: newtropenija
English: Day 1: ≥1.5 x 109/L
Maltese: Jum 1: ≥1.5 x 109/L
English: If a patient experiences a second Grade 1 or 2 infusion-related reaction (IRR) administer dexamethasone (or equivalent); then, for subsequent infusions, premedicate with the following or equivalent medicinal products: an intravenous histamine H1 antagonist (for example diphenhydramine hydrochloride), paracetamol and dexamethasone.
Maltese: Jekk pazjent ikollu it-tieni reazzjoni ta' Grad 1 jew 2 marbuta mal-infużjoni (IRR- infusion related reaction) agħti dexamethasone (jew mediċina ekwivalenti); imbagħad, għal infużjonijiet sussegwenti, ippremedika bil-prodotti mediċinali li ġejjin jew prodotti mediċinali ekwivaleni għalihom: amministrazzjoni ġol vina ta' antagonist ta' istamina H1 (per eżempju diphenhydramine hydrochloride), paracetamol udexamethasone.
English: REVEL, a randomised, double-blind study of Cyramza plus docetaxel versus placebo plus docetaxel, was conducted in 1253 patients with locally advanced or metastatic squamous or non-squamous NSCLC with disease progression on or after one platinum-based therapy.
Maltese: REVEL REVEL, studju ta' Cyramza u docetaxel versus plaċebo u docetaxel, fejn la l-pazjenti li ntgħazlu b'mod arbitrarju u lanqas l-investigaturi ma kienu jafu liema sustanza qed titnuża, sar f'1,253 pazjent b'NSCLC avvanzat b'mod lokali jew metastatiku skwamuż jew mhux skwamuż bi progressjoni talmarda waqt jew wara terapija waħda abbażi tal-platinum.
English: The target organs identified in repeated dose cynomolgus monkey toxicity studies were kidney (glomerulonephritis), bone (thickening and abnormal endochondral ossification of the epiphyseal growth plate) and female reproductive organs (decreased weight of ovaries and uterus).
Maltese: L-organi fil-mira identifikati fi studji ta' effett tossiku minn dożi ripetuti f'xadini cynomolgus kienu l kliewi (glomerulonefrite), l-għadam (żieda fil-ħxuna u ossifikazzjoni endokondrali mhux normali taż żona epifisjali ta' tkabbir) u l-organi ta' riproduzzjoni tal-mara (tnaqqis fil-piż tal-ovarji u l-utru).
English: - A hole in the wall of your gut (‘gastrointestinal perforation'): Cyramza may increase the risk of developing a hole in the wall of your gut.
Maltese: - Toqba fil-membrana tal-istonku jew tal-musrana (‘perforazzjoni gastrointestinali'): Cyramza jista' jżid ir-riskju ta' toqba fil-membrana tal-istonku jew tal-musrana tiegħek.
English: Day 1: ≥100 x 109/L
Maltese: Jum 1: ≥100 x 109/L
English: Cyramza plus paclitaxel arm was 27.9% and in the placebo plus paclitaxel arm was 16.1%.
Maltese: L-ORR fil-fergħa ta' Cyramza u paclitaxel kienet 27.9% u fil-fergħa ta' plaċebo u paclitaxel kienet 16.1%.
English: Hepatic encephalopathy or hepatorenal syndrome (see section 4.4).
Maltese: Enkefalopatija epatika jew sindromu epatorenali (ara sezzjoni 4.4).
English: Elderly patients with NSCLC
Maltese: Pazjenti anzjani b'NSCLC
English: The recommended dose of ramucirumab is 10 mg/kg on day 1 of a 21 day cycle, prior to docetaxel infusion.
Maltese: Id-doża rrakkomandata ta' ramucirumab hija ta' 10 mg/kg f'jum 1 minn ċiklu ta' 21 jum, qabel infużjoni ta' docetaxel.