FrancophonIA/ELRC3.0 huggingface dataset:
English: The threshold for the elevated AFP study entry requirement for REACH-2 was determined based on the survival results from a pre-specified subgroup, exploratory analysis from REACH, a previously completed, supportive phase 3 clinical study in 565 HCC patients randomised (1:1) to either Cyramza plus BSC or placebo plus BSC that had disease progression on or after prior sorafenib therapy.
Maltese: Illivell massimu biex wieħed jidħol fl-istudju tal-AFP elevat għal REACH-2 kien determinat skont irriżultati ta' sopravivenza minn sottogrupp speċifikat minn qabel, analiżi esploratorja minn REACH, studju kliniku supportiv,komplut preċedentement ta' fażi 3 f'565 pazjent b'HCC magħżula b'mod arbitrarju (1:1) għal jew Cyramza flimkien ma' BSC jew plaċebo flimkien ma' BSC li kellhom progressjoni tal-marda waqt jew wara terapija preċedenti b'sorafenib.
English: No dose reductions are recommended (see sections 4.4 and 5.1).
Maltese: Ma huwa rrakkomandat l-ebda tnaqqis fid-doża (ara sezzjonijiet 4.4 u 5.1).
English: Progression-free survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.635; 95% CI: 0.536 to 0.752; p<0.0001).
Maltese: Sopravivenza mingħajr progressjoni tjiebet b'mod statistikament sinifikanti f'pazjenti li kienu qed jirċievu Cyramza u paclitaxel meta mqabbla ma' dawk li kienu qed jirċievu plaċebo u paclitaxel (HR 0.635; 95% CI: 0.536 sa 0.752; p<0.0001).
English: Cyramza 10 mg/ml sterile concentrate ramucirumab
Maltese: TAL-PRODOTT MEDIĊINALI Cyramza 10 mg/ml konċentrat għal soluzzjoni għall-infużjoni ramucirumab
English: Ramucirumab in combination with FOLFIRI
Maltese: Plaċebo u FOLFIRI
English: Two-thirds of the patients experienced disease progression while still on first-line therapy (66.8%).
Maltese: Tnejn minn kull tliet pazjenti kellhom progressjoni tal-marda waqt li kien għadhom fuq it-terapija li tintuża l-ewwel (66.8%).
English: Patients were randomised in a 2:1 ratio to receive an intravenous infusion of Cyramza 8 mg/kg (n= 238) or placebo (n= 117) every 2 weeks.
Maltese: Il-pazjenti ġew magħżula b'mod arbitrarju fi proporzjon ta' 2:1 biex jirċievu infużjoni fil-vina ta' 8 mg/kg Cyramza (n= 238) jew plaċebo (n= 117) kull ġimgħatejn.
English: Thrombocytopeniaa Neutropeniaa
Maltese: Tromboċitopenija a Newtropenijaa
English: Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome.
Maltese: Terapija b'ramucirumab għandha titwaqqaf b'mod permanenti jekk il-livell tal-proteina fl-awrina jkun >3 g/24 siegħa jew f'każ ta' sindrome nefrotika.
English: There was no clear deviation from dose proportionality in pharmacokinetics of ramucirumab from 6 mg/kg to 20 mg/kg.
Maltese: Ma kien hemm l-ebda devjazzjoni ċara mill-proporzjonalità tad-doża fil-farmakokinetika ta' ramucirumab minn 6 mg/kg sa 20 mg/kg.
English: Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia have been reported in clinical studies.
Maltese: inkluż infart mijokardijaku, arrest kardijaku, inċident ċerebrovaskulari, u iskemija ċerebrali ġew irrappurtati fi studji kliniċi.
English: No drug-drug interactions were observed between ramucirumab and paclitaxel.
Maltese: Ma kienu osservati l-ebda interazzjonijiet ta' mediċina-mediċina bejn ramucirumab u paclitaxel.
English: In RAISE, the incidence of Grade ≥3 neutropenia was increased with higher ramucirumab exposure.
Maltese: F'RAISE, l-inċidenza ta' newtropenija ta' Grad ≥3 żdiedet ma' espożizzjoni ogħla għal ramucirumab.
English: Figure 8: Kaplan-Meier curves of Overall Survival for Cyramza versus placebo in REACH-2
Maltese: Figura 8: Graff Kaplan-Meier ta' Sopravivenza in Ġenerali għal Cyramza kontra plaċebo f'REACH-2
English: Only use sodium chloride 9 mg/ml (0.9%) solution for injection as a diluent.
Maltese: 9 mg/ml (0.9%) qabel l-użu.
English: i Based on study RAINBOW (ramucirumab plus paclitaxel) and study REVEL (ramucirumab plus docetaxel).
Maltese: i Skont l-istudju RAINBOW (ramucirumab flimkien ma' paclitaxel) u l-istudju REVEL (ramucirumab flimkien ma' docetaxel).
English: The pharmacokinetics of irinotecan and its active metabolite, SN-38, were not affected when co-administered with ramucirumab.
Maltese: Il-farmakokinetika ta' irinotecan u tal-metabolit attiv tiegħu, SN-38, ma ġietx affettwata meta ngħata flimkien ma' ramucirumab.
English: Pack of 1 vial of 10 ml.
Maltese: Pakkett ta' kunjett wieħed ta' 10 ml.
English: Cmin prior to administration of the second, fourth and seventh dose of ramucirumab were 23.5 μg/ml (range of 2.9-76.5 μg/ml), 44.1 μg/ml (range of 4.2-137 μg/ml) and 60.2 μg/ml (range of
Maltese: Fis-serum ta' pazjenti b'HCC, il-medji ġeometriċi tas-Cmin ta' ramucirumab qabel ma tingħata t-tieni, ir-raba' u s-seba' doża ta' ramucirumab kienu 23.5 μg/ml (medda ta' 2.9-76.5 μg/ml), 44.1 μg/ml (medda ta' 4.2-137 μg/ml) u 60.2 μg/ml (medda ta' 18.
English: The most common adverse reactions observed in ramucirumab-treated patients are: neutropenia, fatigue/asthenia, leukopenia, epistaxis, diarrhoea and stomatitis.
Maltese: Każijiet tromboemboliċi fl-arterji (ara sezzjoni 4.4) L-aktar reazzjonijiet avversi komuni osservati f'pazjenti ttrattati b'ramucirumab huma: newtropenija, għeja/astenja, lewkopenija, epistassi, dijarea, u stomatite.
English: Eleven (2.2%) of ramucirumab treated patients and two (0.5%) of control treated patients developed ADAs.
Maltese: Ħdax (2.2%) millpazjenti kkurati b'ramucirumab u żewġ (0.5%) pazjenti kkurati b'kontroll żviluppaw ADAs.
English: If there is medically significant hypertension that cannot be controlled safely with antihypertensive therapy, ramucirumab therapy should be permanently discontinued (see section 4.4).
Maltese: Jekk ikun hemm ipertensjoni li tkun medikament sinifikanti u li ma tistax tiġi kkontrollata b'mod sikur b'terapija antiipertensiva, it-terapija b'ramucirumab għandha titwaqqaf b'mod permanenti (ara sezzjoni 4.4).
English: The HR of OS was 0.82 (95% CI: 0.67 to 1.0) in patients with a KRAS wild type tumour, and 0.89 (95% CI: 0.73 to 1.09) in patients with a KRAS mutant tumour.
Maltese: 82 (95% CI: 0.67 sa 1.0) f'pazjenti b'tumur bi KRAS tat-tip li jinstab fin-natura, u 0.89 (95% CI: 0.73 sa 1.09) f'pazjenti b'tumur b'mutazzjoni fi KRAS.
English: Randomisation was stratified by geographic region, gender, prior maintenance, and ECOG PS. Cyramza at 10 mg/kg or placebo and docetaxel at 75 mg/m2 were each administered by intravenous infusion on day 1 of a 21-day cycle.
Maltese: manteniment qabel, u l-PS ta' ECOG. Cyramza bid-doża ta' 10 mg/kg jew plaċebo u docetaxel bid doża ta' 75 mg/m2 lkoll ingħataw permezz ta' infużjoni fil-vina f'jum 1 minn ċiklu ta' 21 jum.
English: Dose level
Maltese: b'2 livelli.
English: - Abnormal urine test (‘proteinuria'): Cyramza may increase the risk of developing or worsening of abnormal levels of protein in the urine.
Maltese: - Test tal-awrina li mhuwiex normali (‘proteinurja'): Cyramza jista' jżid ir-riskju li jiżviluppaw jew imorru għall-agħar livelli mhux normali ta' proteina fl-awrina.
English: How to store Cyramza
Maltese: X'fih Cyramza
English: 5-FU bolus
Maltese: 5-FU b'livell 1.
English: 50 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
Maltese: Soluzzjoni ta' 50 ml f'kunjett (ħġieġ tat-Tip I) b'tapp tal-lastku chlorobutyl, siġill tal-aluminju u għatu tal-polypropylene.
English: The primary endpoint was OS and the secondary endpoints included PFS, objective response rate (ORR) and quality of life (QoL) using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.
Maltese: L-iskop finali primarju kien OS u l-iskopijiet finali sekondarji kienu jinkludu PFS, rata oġġettiva ta' rispons (ORR-objective response rate) u l-kwalità tal-ħajja (QoL) bl-użu tal-QLQ-C30 tal-Organizzazzjoni Ewropea għar-Riċerka u t-Trattament tal-Kanċer (EORTC - European Organisation for Research and
English: Warnings and precautions
Maltese: Avvenimenti Avversi
English: g Based on study RAISE (ramucirumab plus FOLFIRI).
Maltese: g Skont l-istudju RAISE (ramucirumab flimkien ma' FOLFIRI).
English: Eligible patients were Child Pugh A (score < 7), had creatinine clearance ≥ 60 ml/min, and ECOG PS of 0 or 1.
Maltese: creatinine ≥ 60 ml/min, u ECOG PS ta' 0 jew 1.
English: 10 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
Maltese: Soluzzjoni ta' 10 ml f'kunjett (ħġieġ tat-Tip I) b'tapp tal-lastku chlorobutyl, siġill tal-aluminju u għatu tal-polypropylene.
English: Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome (see section 4.2).
Maltese: Il-kura b'ramucirumab għandha titwaqqaf b'mod permanenti jekk il-livell tal-proteina fl-awrina jkun ta' >3 g/24 siegħa jew f'każ ta' sindrome nefrotika (ara sezzjoni 4.2).
English: Rate - percent (95% CI)
Maltese: Rata - perċentwal (95% CI)
English: Docetaxel dose adjustments
Maltese: Tfal u adolexxenti
English: Figure 6: Kaplan-Meier curves of overall survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Maltese: Kaplan-Meier tas-sopravivenza totali għal Cyramza u docetaxel versus plaċebo u docetaxel f'REVEL
English: Post discontinuation systemic anti-cancer therapy was given to 47.9% of patients receiving Cyramza plus paclitaxel and 46.0% of patients receiving placebo plus paclitaxel.
Maltese: Wara l-waqfien mill-kura tal-istudju ingħatat terapija sistemika kontra l-kanċer lil 47.9% tal-pazjenti li kienu qed jirċievu Cyramza u paclitaxel u 46.0% tal-pazjenti li kienu qed jirċievu plaċebo u paclitaxel.
English: These and other factors investigated had < 20 % effect on ramucirumab disposition.
Maltese: Dawn u fatturi oħra li ġew investigati kellhom < 20 % ta' effett fuq id-dispożizzjoni ta' ramucirumab.
English: Ramucirumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Maltese: IgG1 uman magħmul f'ċelluli tal-ġrieden u firien (NS0) permezz ta' teknoloġija rikombinanti tad-DNA.
English: Following the dose regimen of 10 mg/kg ramucirumab every 3 weeks, the geometric means of ramucirumab Cmin were 28.3 μg/ml (range of 2.5-108 μg/ml) and 38.4 μg/ml (range of 3.1-128 μg/ml)
Maltese: Wara l-programm ta' kura b'doża ta' 10 mg/kg ramucirumab kull tliet ġimgħat, il-medji ġeometriċi tas-Cmin ta' ramucirumab kienu 28.3 μg/ml (firxa ta' 2.5-108 μg/ml) u 38.4 μg/ml (firxa ta' 3.1
English: The disease control rate (complete response plus partial response plus stable disease) was numerically higher in patients on the ramucirumab plus FOLFIRI arm as compared to the placebo plus FOLFIRI arm (74.1% versus 68.8%, respectively).
Maltese: Ir-rata ta' kontroll tal-marda (rispons sħiħ flimkien ma' rispons parzjali flimkien ma' marda stabbli) kienet ogħla b'mod numerikali f'pazjenti fuq il-fergħa ta' ramucirumab u FOLFIRI meta mqabbla mal-fergha tal-plaċebo u FOLFIRI (74.1% vs. 68.8%, rispettivament).
English: Cyramza at 8 mg/kg or placebo was administered by intravenous infusion every 2 weeks (on days 1 and 15) of a 28-day cycle.
Maltese: Cyramza b'doża ta' 8 mg/kg jew plaċebo ingħata b'infużjoni fil-vina kull ġimgħatejn (fil-jiem 1 u 15) f'ċiklu ta' 28 jum.
English: The relative treatment effect (assessed by HR) of Cyramza compared to placebo was generally consistent across subgroups, including age, race, aetiology of disease and reason for discontinuation of sorafenib (progressive disease vs. intolerance).
Maltese: L-effett relattiv ta' trattament (evalwat minn HR) ta' Cyramza meta mqabbel ma' plaċebo kien fil-parti l-kbira konsistenti fost is-sottogruppi, li kienu jinkludu l-età, razza, l-etjoloġija tal-marda u raġuni għat-twaqqif ta' sorafenib (progressjoni tal-marda vs. intolleranza).
English: b Based on study RAINBOW (ramucirumab plus paclitaxel).
Maltese: b Skont l-istudju RAINBOW (ramucirumab flimkien ma'paclitaxel).
English: Cyramza is a concentrate for solution for infusion (also called “sterile concentrate”).
Maltese: Cyramza huwa konċentrat għal soluzzjoni għall-infużjoni (msejjaħ ukoll “konċentrat sterili”).
English: Randomisation was stratified by geographic region, tumour KRAS status (mutant or wild-type), and time to disease progression (TTP) after commencing first-line treatment (<6 months versus ≥6 months).
Maltese: KRAS tat-tumur (mutanti jew li jinstab fin-natura), u ż-żmien sal-progressjoni tal-marda (TTP - time to disease progression) wara li jkun inbeda t-trattament tal-ewwel faxx (<6 xhur versus ≥6 xhur).
English: Vials contain either 100 mg or 500 mg as a 10 mg/ml solution of ramucirumab.
Maltese: Ilkunjetti fihom 100 mg jew 500 mg bħala soluzzjoni ta' 10 mg/ml ta' ramucirumab.
English: In the pooled data from REACH-2 and REACH (patients with alpha fetoprotein ≥ 400 ng/ml), the incidences of Grade ≥ 3 hypertension was increased with higher ramucirumab exposure.
Maltese: Mill-ġabra ta' tagħrif minn REACH-2 u REACH (pazjenti b'fetoproteina alfa ≥ 400 ng/ml), l inċidenzi ta' ipertensjoni ta' Grad ≥ 3 żdiedu b'espożizzjoni aktar għolja ta' ramucirumab. 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà
English: Reduce by 2 dose levels for 5-FU and irinotecan.
Maltese: Naqqas id-doża ta' 5-FU u irinotecan b'2 livelli.
English: Peripheral oedema Infusion-related reactionsa a Terms represent a group of events that describe a medical concept rather than a single event or preferred term.
Maltese: It-termini jirrappreżentaw grupp ta' avvenimenti li jiddeskrivu kunċett mediku aktar milli jiddeskrivu avveniment wieħed jew terminu preferut.
English: Name and address of the manufacturers of the biological active substance ImClone Systems LLC
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva
English: The safety and efficacy of Cyramza in children and adolescents (<18 years) has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Cyramza fit-tfal u fl-adolexxenti (<18-il sena) ma ġewx determinati s'issa.
English: (n= 39) suggested a survival benefit in such patients (HR 0.679, 95% CI 0.327, 1.419) and demonstrated a benefit for progression free survival (PFS) (HR 0.399, 95% CI 0.194, 0.822).
Maltese: sottogrupp ta' pazjenti f'RAINBOW li preċedentemnet kienu kkurati b'trastuzumab (n= 39) tissuġġerixxi benefiċċju ta' sopravivenza f'dawn il-pazjenti (HR 0.679, 95% CI 0.327, 1.419) u wriet benefiċċju ta' sopravivenza mingħajr progressjoni tal-marda (PFS) (HR 0.399, 95% CI 0.194, 0.822).
English: Severe gastrointestinal haemorrhage, including fatal events, were reported in patients with gastric cancer treated with ramucirumab in combination with paclitaxel, and in patients with mCRC treated with ramucirumab in combination with FOLFIRI.
Maltese: Ġew irrappurtati emorraġiji gastrointestinali severi, inkluż każijiet fatali, f'pazjenti b'kanċer tal istonku ttrattati b'ramucirumab flimkien ma' paclitaxel, u f'pazjenti b'mCRC ittrattati b'ramucirumab flimkien ma' FOLFIRI.
English: Time and dose dependency
Maltese: CI = confidence interval
English: c Based on study RAINBOW (ramucirumab plus paclitaxel).
Maltese: c Skont l-istudju RAINBOW (ramucirumab flimkien ma' paclitaxel).
English: Ramucirumab should be permanently discontinued in the event of hepatic encephalopathy or hepatorenal syndrome (see section 4.2).
Maltese: Ramucirumab għandu jitwaqqaf b'mod permanenti f'każ ta' enkefalopatija epatika jew sindromu epatorenali (ara sezzjoni 4.2).
English: f Based on study RAINBOW (ramucirumab plus paclitaxel) and study RAISE (ramucirumab plus FOLFIRI).
Maltese: f Skont l-istudju RAINBOW (ramucirumab flimkien ma' paclitaxel) u l-istudju RAISE (ramucirumab flimkien ma' FOLFIRI).
English: Figure 4: Kaplan-Meier curves of overall survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
Maltese: Kaplan-Meier ta' sopravivenza totali għal Cyramza u FOLFIRI versus plaċebo u FOLFIRI f'RAISE
English: Premedication is recommended with a histamine H1 antagonist (for example diphenhydramine) prior to infusion of ramucirumab.
Maltese: Hija rrakkomandata premedikazzjoni b'antagonist ta' istamina H1 (per eżempju diphenhydramine) qabel l-infużjoni ta' ramucirumab.
English: If Grade 4 diarrhoea does not resolve to Grade ≤1, withhold 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1.
Maltese: Jekk id-dijarea ta' Grad 4 ma tgħaddix għal Grade ≤1, ipposponi l-għoti ta' 5-FU u irinotecan għal massimu ta' 28* jum sakemm tgħaddi għal Grad ≤1.
English: 4.4), patients pre-treated with taxanes (HR 0.81; 95% CI:0.62 to 1.07; mOS 10.8 vs 10.4 months) and those with time since start of prior therapy ≥9 months (HR 0.95; 95% CI: 0.75 to 1.2; mOS: 13.7 vs
Maltese: 4 xhur) u dawk bi żmien ta' ≥9 xhur mill-bidu tat-terapija ta' qabel (HR 0.95; 95% CI: 0.75 sa 1.2; mOS: 13.7 vs
English: Patients were randomised in a 1:1 ratio to receive Cyramza plus docetaxel (n=628) or placebo plus docetaxel (n=625).
Maltese: Il-pazjenti ntagħżlu bi proporzjon ta' 1:1 biex jew jirċievu Cyramza u docetaxel (n=628) jew plaċebo u docetaxel
English: 10.5 months in the Cyramza plus docetaxel arm and 9.1 months in the placebo plus docetaxel arm. PFS was statistically significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (HR 0.762; 95% CI: 0.677 to 0.859; p<0.001).
Maltese: Il-PFS tjieb b'mod sinifikanti u statistiku f'pazjenti li kienu qed jirċievu Cyramza u docetaxel meta mqabbla ma' dawk li kienu qed jirċievu plaċebo u docetaxel (HR 0.762; 95% CI: 0.677 sa 0.859;
English: Each 10 ml vial contains approximately 17 mg sodium.
Maltese: Kull kunjett ta' 10 ml fih madwar 17 -il mg sodium.
English: Ramucirumab should be permanently discontinued in patients who experience gastrointestinal perforations (see section 4.2).
Maltese: Ramucirumab għandu jitwaqqaf b'mod permanenti f'pazjenti li jkollhom perforazzjonijiet gastrointestinali (ara sezzjoni 4.2).
English: The median relative dose intensity of paclitaxel was 87.7% for the Cyramza plus paclitaxel arm and 93.2% for the placebo plus paclitaxel arm. A similar percentage of patients discontinued treatment due to adverse events: 12% of patients treated with Cyramza plus paclitaxel compared with 11% of patients treated with placebo plus paclitaxel.
Maltese: Perċentwal simili ta' pazjenti waqqfu l-kura minħabba każijiet avversi: 12% tal-pazjenti kkurati b'Cyramza u paclitaxel meta mqabbla ma' 11% tal-pazjenti kkurati bi plaċebo u paclitaxel.
English: Cyramza will be permanently stopped if you develop a fistula.
Maltese: Cyramza jitwaqqaf b'mod permanenti jekk inti tiżviluppa fistla.
English: Figure 2: Kaplan-Meier curves of progression-free survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Maltese: Kaplan-Meier ta' sopravivenza mingħajr progressjoni għal Cyramza u paclitaxel versus plaċebo u paclitaxel f'RAINBOW
English: Patients in two Phase 3 studies, RAINBOW and REGARD were tested at multiple time-points for anti-drug antibodies (ADAs).
Maltese: Immunoġeniċità Il-pazjenti f'żewġ studji ta' Fażi 3, RAINBOW u REGARD ġew ittestjati f'ħafna punti ta' żmien għal antikorpi kontra l-mediċina (ADAs - anti-drug antibodies).
English: Ramucirumab is an antiangiogenic therapy and may increase the risk of severe bleeding.
Maltese: Fsada severa Ramucirumab huwa terapija antianġjoġenika u jista' jżid ir-riskju ta' fsada severa.
English: Figure 1: Kaplan-Meier curves of overall survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Maltese: Kaplan-Meier ta' sopravivenza totali għal Cyramza u paclitaxel versus plaċebo u paclitaxel f'RAINBOW
English: Based on PopPK, the mean (CV%) clearance of ramucirumab was 0.015 L/hour (30%) and the mean half-life was 14 days (20%).
Maltese: L/siegħa (30%) u lmedja tal-half-life kienet 14-il jum (20%).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni ta' rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: the geometric means of ramucirumab Cmin were 46.3 μg/ml (range of 7.7-119 μg/ml) and 65.1 μg/ml
Maltese: il-medji ġeometriċi tas-Cmin ta' ramucirumab kienu 46.3 μg/ml (firxa ta' 7.7-119 μg/ml) u 65.1 μg/ml (firxa ta' 14.5-205 μg/ml) qabel l-għoti tat-tielet u l-ħames doża, rispettivament, fis-serum minn pazjenti b'mCRC.
English: However, since ramucirumab is an antiangiogenic therapy and may have the potential to adversely affect wound healing, ramucirumab treatment should be withheld for at least 4 weeks prior to scheduled surgery.
Maltese: minħabba li ramucirumab huwa terapija antianġjoġenika u jista' jkollu l-potenzjal li jaffettwa l-fejqan ta' feriti b'mod avvers, kura b'ramucirumab għandha titwaqqaf għal mill-inqas 4 ġimgħat qabel kirurġija skedata.
English: Tél: +33-(0) 1 55 49 34 34
Maltese: Lilly France SAS Tél: +33-(0) 1 55
English: Withhold 5-FU for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 dose levels for 5-FU.
Maltese: Ipposponi 5-FU għal massimu ta' 28* jum sakemm jgħaddu għal Grad ≤1, imbagħad naqqas id-doża ta' 5-FU b'2 livelli.
English: OS was statistically significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (HR 0.857; 95% CI: 0.751 to 0.979; p=0.024).
Maltese: L-OS tjieb b'mod sinifikanti u statistiku f'pazjenti li kienu qed jirċievu Cyramza u docetaxel meta mqabbel ma' dawk li kienu qed jirċievu plaċebo u docetaxel (HR 0.857; 95% CI: 0.751 sa 0.979;
English: RAINBOW, a global, randomised, double-blind, study of Cyramza plus paclitaxel versus placebo plus paclitaxel, was conducted in 665 patients with locally recurrent and unresectable or metastatic gastric cancer (including GEJ adenocarcinoma) following platinum- and fluoropyrimidine-containing chemotherapy, with or without anthracycline.
Maltese: RAINBOW RAINBOW, studju globali, double-blind ta' Cyramza u paclitaxel versus plaċebo u paclitaxel, li fih il pazjenti ntgħażlu b'mod arbitrarju, sar f'665 pazjent b'kanċer tal-istonku (inkluż adenokarċinoma
English: Figure 7: Kaplan-Meier curves of progression-free survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Maltese: Kaplan-Meier ta' sopravivenza mingħajr progressjoni għal Cyramza u docetaxel versus plaċebo u docetaxel f'REVEL
English: Fatiguea,i Mucosal inflammationd Peripheral oedema a Terms represent a group of events that describe a medical concept rather than a single event or preferred term.
Maltese: Reazzjonijiet marbuta mal infużjonia a It-termini jirrappreżentaw grupp ta' avvenimenti li jiddeskrivu kunċett mediku aktar milli jiddeskrivu avveniment wieħed jew terminu preferut.
English: After dilution, Cyramza is administered as an intravenous infusion over approximately 60 minutes.
Maltese: Wara d-dilwizzjoni, Cyramza jingħata bħala infużjoni filvina fuq perjodu ta' madwar 60 minuta.
English: This is equivalent to approximately 4% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal madwar 4 % tat-teħid massimu ta' sodium mid-dieta rrakkomandat għal ġurnata għal adult.
English: Ramucirumab should be permanently discontinued if medically significant hypertension cannot be controlled with antihypertensive therapy (see section 4.2).
Maltese: Ramucirumab għandu jitwaqqaf b'mod permanenti jekk l-ipertensjoni tkun medikament sinifikanti u ma tkunx tista' tiġi kkontrollata b'terapija antiipertensiva (ara sezzjoni 4.2).
English: Severe gastrointestinal haemorrhage (see section 4.4) Arterial thromboembolic events (see section 4.4)
Maltese: Każijiet tromboemboliċi severi fl-arterji (ara sezzjoni 4.4).