FrancophonIA/ELRC3.0 huggingface dataset:
English: during treatment with Cyramza or anytime thereafter: - Blocking of the arteries by a blood clot (‘arterial thromboembolic events'):
Maltese: Każijiet tromboemboliċi serji, xi kultant fatali, fl-arterji (ATEs - arterial thromboembolic events)
English: Each 50 ml vial contains approximately 85 mg sodium (main component of cooking/table salt).
Maltese: Kull kunjett ta' 50 ml fih madwar 85 mg ta' sodium (l-ingredjent prinċipali fil-melħ għat-tisjir u għall-ikel).
English: Ramucirumab should be used with caution in patients with severe liver cirrhosis (Child-Pugh B or C), cirrhosis with hepatic encephalopathy, clinically significant ascites due to cirrhosis, or hepatorenal syndrome.
Maltese: Ramucirumab għandu jintuża b'kawtela f'pazjenti b'ċirrożi severa tal-fwied (Child-Pugh B jew C), ċirrożi b'enċefalopatija epatika, axxite klinikament sinifikanti minħabba ċirrożi, jew sindrome epatoreanali.
English: Reproductive toxicity studies with ramucirumab have not been performed, however, animal models link angiogenesis, VEGF and VEGF Receptor 2 to critical aspects of female reproduction, embryo-foetal development, and postnatal development.
Maltese: Ma sarux studji dwar tossiċità fuq is-sistema riproduttiva b'ramucirumab, madankollu, mudelli talannimali (animal models) urew konnessjoni bejn anġjoġenesi, VEGF u Riċettur 2 ta' VEGF, u aspetti kritiċi ta' riproduzzjoni fin-nisa, żvilupp tal-embriju u tal-fetu, u żvilupp wara t-twelid.
English: In addition, patients were either Barcelona Clinic Liver Cancer (BCLC) stage B and no longer amenable to locoregional therapy, or were BCLC stage C. Patients with brain metastases, leptomeningeal disease, uncontrolled spinal cord compression, a history of or current hepatic encephalopathy or clinically meaningful ascites, severe variceal bleeding in the 3 months prior to treatment, or gastric or oesophageal varices at high risk of bleeding were excluded from the study.
Maltese: Pazjenti b'metastasi fil-moħħ, marda leptomeninġeali, kompressjoni bla kontroll tannervituri tas-sinsla tad-dahar, enkefalopatija epatika fil-passat jew kurrenti jew axxite klinikament rilevanti, fsada variċeali severa fit-3 xhur qabel it-trattament, jew variċi gastriċi jew esofagali f'riskju għoli ta' fsada kienu esklużi mill-istudju.
English: Patients receiving any kind of therapeutic anticoagulation and/or chronic therapy with non-steroidal anti-inflammatory drugs or anti-platelet agents were excluded from the REVEL NSCLC clinical trial.
Maltese: Pazjenti li qed jirċievu kwalunkwe tip ta' antikoagulazzjoni terapewtika u/jew terapija kronika b'mediċini antiinfjammatorji li mhumiex sterojdi jew sustanzi li jaħdmu kontra l-plejtlits kienu esklużi mill-prova klinika REVEL NSCLC.
English: If stomatitis/mucositis has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Maltese: Jekk l-istomatite/mukosite jirkupraw għal Grad ≤1, naqqas id doża ta' 5-FU b'livell 1.
English: Haematological criteria in Table 2 are not met and fever resolved
Maltese: Il-kriterji ematoloġiċi f'Tabella 2 ma ntlaħqux u d deni niżel
English: The primary QoL analysis showed similar time to deterioration for all Lung Cancer Symptom Scale (LCSS) scores between treatment arms.
Maltese: L-investigazzjonijiet primarji tal-Kwalità tal-Ħajja (QoL - Quality of Life) urew żminijiet simili għal deterjorament bejn il-fergħat ta' trattament għall-punteġġi kollha fuq l-Iskala ta' Sintomi tal-Kanċer tal-Pulmun (LCSS - Lung Cancer Symptom Scale).
English: Cyramza):
Maltese: Fsada severa:
English: Hazard ratio (95% CI) Stratified log-rank p-value 12-week PFS rate% (95% CI) Abbreviations: CI = confidence interval
Maltese: Medjan (95% CI) Hazard ratio (95% CI) Stratified log-rank p-value Rata ta' Rispons Oġġettiv (CR + PR) ORR % (95% CI) p-value Abbrevjazzjonijiet:
English: Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1).
Maltese: Cyramza flimkien ma' paclitaxel huwa indikat għall-kura ta' pazjenti adulti b'kanċer avvanzat talistonku jew b'adenokarċinoma fl-għaqda gastro-esofaġali bi progressjoni tal-marda wara li tkun ingħatat kimoterapija li jkun fiha platinum u fluoropyrimidine (ara sezzjoni 5.1).
English: In case of overdose, supportive therapy should be used.
Maltese: għandha tintuża terapija ta' sostenn.
English: For patients with TTP ≥6 months after commencing first-line treatment the HR of OS was 0.86 (95% CI: 0.73 to 1.01), and 0.86 (95% CI: 0.64 to 1.13) in patients with TTP <6 months after commencing first-line treatment.
Maltese: Għal pazjenti b'TTP ≥6 xhur wara li jkunu bdew it-trattament tal-ewwel faxx l-HR ta' OS kien 0.86 (95% CI: 0.73 sa 1.01), u 0.86 (95% CI: 0.64 sa 1.13) f'pazjenti b'TTP <6 xhur wara li jkunu bdew it-trattament tal-ewwel faxx.
English: Vascular disorders
Maltese: Distrubi vaskulari
English: Progression-free survival was statistically significantly improved in patients receiving Cyramza as compared with patients receiving placebo (HR 0.483; 95%CI: 0.376 to 0.620; p<0.0001), corresponding to a 52% reduction in the risk of progression or death and an increase in median PFS to 2.1 months for Cyramza from 1.3 months for placebo.
Maltese: Sopravivenza mingħajr progressjoni tjiebet b'mod statistikament sinifikanti f'pazjenti li kienu qed jirċievu Cyramza meta mqabbla ma' pazjenti li kienu qed jirċievu plaċebo (HR 0.483; 95% CI: 0.376 sa 0.620; p < 0.0001), li jaqbel ma' tnaqqis ta'
English: Patients were also excluded if they had experienced any of: an ATE, Grade 4 hypertension, Grade 3 proteinuria, a grade 3-4 bleeding event, or bowel perforation during first-line bevacizumab therapy.
Maltese: Grad 4, proteinurja ta' Grad 3, avveniment ta' ħruġ ta' demm ta' grad 3-4, jew perforazzjoni talmusrana waqt it-terapija tal-ewwel faxx b'bevacizumab.
English: One ml of concentrate for solution for infusion contains 10 mg of ramucirumab.
Maltese: U KWANTITATTIVA Millilitru wieħed ta' konċentrat għal soluzzjoni għall-infużjoni fih 10 mg ramucirumab.
English: Ramucirumab should be immediately and permanently discontinued in the event of a grade 3 or 4 IRR (see section 4.4).
Maltese: Ramucirumab għandu jitwaqqaf b'mod immedjat u permanenti f'każ ta' IRR ta' grad 3 jew 4 (ara sezzjoni 4.4).
English: The recommended dose of docetaxel is 75 mg for every square metre (m²) of your body's surface area once every 3 weeks.
Maltese: Id-doża rrakkomandata ta' docetaxel hija 75 mg/m2 mogħtija permezz ta'
English: Patients treated with Cyramza experienced a statistically significant improvement in OS, compared to placebo (Table 12).
Maltese: Il pazjenti ttrattati b'Cyramza kellhom titjib statistikament sinifikanti fl-OS meta mqabbel ma' plaċebo (Tabella 12).
English: Ramucirumab therapy should be temporarily discontinued if the urine protein level is ≥2 g/24 hours.
Maltese: Il-kura b' ramucirumab għandha titwaqqaf b'mod temporanju jekk il-livell tal-proteina fl-awrina tkun ≥2 g/24 siegħa.
English: Add a sufficient quantity of sodium chloride 9 mg/ml (0.9%) solution for injection to the container to make the total volume 250 ml.
Maltese: Żid kwantità biżżejjed ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%)
English: There was an increase in median PFS of 1.5 months in favour of the Cyramza plus paclitaxel arm: 4.4 months in the Cyramza plus paclitaxel arm and 2.9 months in the placebo plus paclitaxel arm.
Maltese: Kien hemm żieda ta' 1.5 xhur fil-medjan ta' PFS favur il-fergħa ta' Cyramza u paclitaxel: 4.4 xhur fil-fergħa ta' Cyramza u paclitaxel u 2.9 xhur fil-fergħa ta' plaċebo u paclitaxel.
English: RAISE was a global, randomised, double-blind, study of Cyramza plus FOLFIRI versus placebo plus FOLFIRI, in patients with mCRC, who had disease progression on or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
Maltese: RAISE RAISE kien studju globali, fejn la l-pazjenti li ntgħażlu b'mod arbitrarju u lanqas l-investigaturi ma kienu jafu liema sustanza qed tintuża, ta' Cyramza u FOLFIRI versus plaċebo u FOLFIRI, f'pazjenti b'mCRC, li kellhom progressjoni tal-marda waqt jew wara t-terapija tal-ewwel faxx b'bevacizumab, oxaliplatin, u wieħed mill-fluoropyrimidines.
English: Unopened vial 3 years.
Maltese: madwar 60 minuta.
English: If you experience an infusion-related reaction during Cyramza therapy, you will be given premedication for all future infusions.
Maltese: Cyramza, inti tingħata premedikazzjoni għal kull infuzjoni oħra fil-futur.
English: Patients with HCC should be selected based on a serum AFP concentration of ≥ 400 ng/ml with a validated AFP test prior to ramucirumab treatment (see section 5.1).
Maltese: L-ittestjar għal Fetoproteina alfa (AFP- Alpha fetoprotein) f'HCC Qabel it-trattament b' ramucirumab, pazjenti b'HCC għandhom jiġu magħżula skont konċentrazzjoni ta' AFP ta' ≥ 400 ng/ml b'test ivvalidat għal AFP (ara sezzjoni 5.1).
English: Ramucirumab therapy should be temporarily discontinued for at least 4 weeks prior to elective surgery.
Maltese: It-terapija b'ramucirumab għandha titwaqqaf b'mod temporanju għal mill-inqas 4 ġimgħat qabel kirurġija elettiva.
English: Table 8: Summary of efficacy data - Intent to treat (ITT) population Cyramza plus paclitaxel N=330
Maltese: Tabella 8: Sommarju tad-dejta ta' effikaċja - Popolazzjoni bl-intenzjoni li tiġi ttrattata (ITT-intent to treat)
English: One ml of concentrate contains 10 mg ramucirumab.
Maltese: Millilitru wieħed ta' konċentrat fih 10 mg ramucirumab.
English: Elective surgery or impaired wound healing
Maltese: Kirurġija elettiva jew dewmien fil-fejqan tal-feriti
English: Gastrointestinal disorders Stomatitis Diarrhoea
Maltese: Tossiċità gastrointestinali marbuta mal-kimoterapija
English: For recurrent Grade 2 diarrhoea, reduce by 1 dose level for 5-FU and irinotecan.
Maltese: Għal dijarea ta' Grad 2 rikurrenti, naqqas id-doża ta' 5-FU u irinotecan b'livell 1.
English: Sites in East Asia administered a reduced dose of docetaxel at 60 mg/m2 every 21 days.
Maltese: Postijiet fl-Asja tal-Lvant taw doża mnaqqsa ta' 60 mg/m2 ta' docetaxel kull 21 jum.
English: It is recommended to reduce the docetaxel dose by 10 mg/m2 for all following cycles.
Maltese: Tnaqqis addizzjonali ta' 10 mg/m2 huwa rrakkomandat jekk dawn it-tossiċitajiet jippersistu jew iseħħu mill-ġdid.
English: There was an increase in median survival of 1.6 months in favour of the Cyramza plus FOLFIRI arm: 13.3 months in the Cyramza plus FOLFIRI arm and 11.7 months in the placebo plus FOLFIRI arm. Progression-free survival was statistically significantly improved in patients receiving Cyramza plus FOLFIRI compared with those receiving placebo plus FOLFIRI (HR 0.793; 95% CI: 0.697 to 0.903; p=0.0005).
Maltese: Sopravivenza mingħajr progressjoni tjiebet b'mod sinifikanti u statistiku f'pazjenti li kienu qed jirċievu Cyramza u FOLFIRI meta mqabbla ma' dawk li kienu qed jirċievu plaċebo u FOLFIRI (HR 0.793; 95%CI: 0.697 sa 0.903; p=0.0005).
English: No patients had neutralising antibodies to ramucirumab.
Maltese: L-ebda pazjent/a ma kellu/ha antikorpi li jinnewtralizzaw kontra ramucirumab.
English: Package leaflet: Information for the user Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab
Maltese: Informazzjoni għall-utent Cyramza 10 mg/ml konċentrat għal soluzzjoni għall-infużjoni ramucirumab
English: ≥65 years old (OS HR 1.10, 95% CI: 0.89, 1.36; median OS [mOS]: 9.2 vs 9.3 months, see section
Maltese: Ma kienu osservati l-ebda differenzi fl-effikaċja bejn il-fergħat ta' trattament fis-sottogrupp ta' pazjenti b'età ≥ 65 sena (OS HR 1.10, 95% CI: 0.89, 1.36; medjan OS [mOS]: 9.2 vs 9.3 xhur, ara sezzjoni 4.4), pazjenti ttrattati qabel b'taxanes (HR 0.81; 95% CI:0.
English: Comorbidities associated with advanced age, performance status and the likely tolerability to chemotherapy should therefore be thoroughly evaluated prior to the initiation of treatment in the elderly (see sections 4.2 and 5.1).
Maltese: Komorbiditajiet assoċjati ma' età avvanzata, listat ta' eżekuzzjoni u t-tollerabbiltà probabbli għall-kimoterapija għandhom għalhekk jiġu vvalutati tajjeb ħafna qabel il-bidu tat-trattament fl-anzjani (ara sezzjonijiet 4.2 u 5.1).
English: In RAINBOW, the incidences of Grade ≥3 hypertension, neutropenia, and leukopenia were increased with higher ramucirumab exposure.
Maltese: F'RAINBOW, l-inċidenzi ta' ipertensjoni, newtropenija u lewkopenija ta' Grad ≥3 żdiedu ma' espożizzjoni ogħla għal ramucirumab.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Cyramza in all subsets of the paediatric population in gastric adenocarcinoma, in adenocarcinoma of the colon and rectum, in lung carcinoma, and liver cancer (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Cyramza f'kull sett tal-popolazzjoni pedjatrika fl-adenokarċinoma tal-istonku, l-adenokarċinoma tal-kolon u tar-rektum, f'karċinoma tal-pulmun u kanċer tal-fwied (ara sezzjoni 4.2 għalinformazzjoni dwar l-użu pedjatriku).
English: The recommended dose of paclitaxel is 80 mg/m2 administered by intravenous infusion over approximately 60 minutes on days 1, 8 and 15 of a 28 day cycle.
Maltese: mogħtija permezz ta' infużjoni fil-vina fuq perjodu ta' madwar 60 minuta fil-jiem numru 1, 8 u
English: Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 levels for
Maltese: Ipposponi 5-FU u irinotecan għal massimu ta' 28* jum sakemm tgħaddi għal Grad ≤1,
English: FOLFIRI treatment over placebo plus FOLFIRI.
Maltese: FOLFIRI versus plaċebo u FOLFIRI f'RAISE
English: Hypoalbuminaemiaa Hyponatraemiaa
Maltese: Ipoalbuminimja Iponatrimjaa
English: Figure 3: Kaplan-Meier curves of overall survival for Cyramza versus placebo in REGARD
Maltese: Kaplan-Meier ta' sopravivenza totali għal Cyramza versus plaċebo f'REGARD
English: There was an increase in median survival of 2.3 months in favour of the Cyramza plus paclitaxel arm: 9.63 months in the Cyramza plus paclitaxel arm and 7.36 months in the placebo plus paclitaxel arm.
Maltese: Kien hemm żieda ta' 2.3 xhur fil-medjan ta' sopravivenza favur il-fergħa ta' Cyramza u paclitaxel: 9.63 xhur fil-fergħa ta' Cyramza u paclitaxel u 7.36 xhur fil-fergħa ta' plaċebo u paclitaxel.
English: The recommended dose of ramucirumab is 8 mg/kg on days 1 and 15 of a 28 day cycle, prior to paclitaxel infusion.
Maltese: Id-doża rrakkkomandata ta' ramucirumab hija ta' 8 mg/kg fil-jiem numru 1 u 15 minn ċiklu ta'
English: Immunogenicity
Maltese: Tromboċitopenija
English: Tables 6 and 7 below list the adverse drug reactions (ADRs) from placebo controlled phase III clinical trials associated with ramucirumab used either as a monotherapy treatment for gastric cancer and HCC or in combination with different chemotherapy regimens for the treatment of gastric cancer, mCRC and NSCLC.
Maltese: III kkontrollati bi plaċebo assoċjati ma' ramucirumab użat jew bħala monoterapija fit-trattament ta' kanċer gastriku u HCC jew f'taħlita flimkien ma' skedi differenti ta' kimoterapija għat-trattament ta' kanċer gastriku, mCRC jew NSCLC.
English: Paclitaxel at 80 mg/m2 was administered by intravenous infusion on days 1, 8, and 15 of each 28-day cycle.
Maltese: infużjoni fil-vina fil-jiem 1, 8, u 15 ta' kull ċiklu ta' 28 jum.
English: Cyramza treatment will be permanently stopped if you:
Maltese: Terapija b'ramucirumab għandha titwaqqaf b'mod permanenti f'każ ta':
English: Ramucirumab should be immediately and permanently discontinued in patients who experience a Grade 3 or 4 IRR (see section 4.2).
Maltese: Ramucirumab għandu jitwaqqaf b'mod immedjat u permanenti f'pazjenti li jkollhom IRR ta' Grad 3 jew 4 (ara sezzjoni 4.2).
English: Overall survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.807; 95% CI: 0.678 to 0.962; p=0.0169).
Maltese: Is-sopravivenza totali tjiebet b'mod statistikament sinifikanti f'pazjenti li kieu qed jirċievu Cyramza u paclitaxel meta mqabbla ma' dawk li kieu qed jirċievu plaċebo u paclitaxel (HR 0.807; 95% CI: 0.678
English: In HCC patients, hepatic encephalopathy was reported at a higher rate in the ramucirumab-treated patients compared to the placebo-treated patients (see section 4.8).
Maltese: F'pazjenti b'HCC, l-enkefalopatija epatika ġiet irrapportata b'rata ogħla fil-pazjenti ttrattati b'ramucirumab meta mqabbla mal-pazjenti ttrattati b'plaċebo (ara sezzjoni 4.8).
English: Dose modifications of each component of FOLFIRI should be made independently and are provided in Table 4.
Maltese: Modifikazzjonijiet fid-doża ta' kull komponent ta' FOLFIRI għandhom isiru b'mod indipendenti u huma mogħtija f'Tabella 4.
English: Randomisation was stratified by weight loss over the prior 3 months (≥ 10% versus < 10%), geographic region, and location of the primary tumour (gastric versus GEJ).
Maltese: L-għażla b'mod arbitrarju ġiet stratifikata skont telf ta' piż fit-3 xhur ta' qabel (≥ 10% versus < 10%), ir-reġjun ġeografiku, u l-post tat-tumur primarju (fl-istonku versus GEJ). Id-demografiċi fil-linja bażi u l-karatteristiċi tal-marda kienu bbilanċjati.
English: Symptoms included rigors/tremors, back-pain/spasms, chest pain and/or tightness, chills, flushing, dyspnoea, wheezing, hypoxia, and paraesthesia.
Maltese: Sintomi kienu jinkludu riġidità/rogħda, uġigħ fid-dahar/spażmi, uġigħ u/jew tagħfis fis-sider, tkexkix ta' bard, fwawar, qtugħ ta' nifs, tħarħir, ipoksja, u paresteżija.
English: Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 levels for 5-FU and irinotecan.
Maltese: Ipposponi l-għoti ta' 5-FU u irinotecan għal massimu ta' 28* jum sakemm tgħaddi għal Grad ≤1, imbagħad naqqas id doża ta' 5-FU u irinotecan b'2 livelli.
English: When receiving Cyramza in combination with paclitaxel or docetaxel
Maltese: Plaċebo u docetaxel
English: Lilly Hungária Kft.
Maltese: Tħawwadx il-kunjett.
English: Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Maltese: Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
English: Cyramza is given in combination with docetaxel, another anti-cancer medicine, for the treatment of adult patients with advanced stage of lung cancer whose disease has worsened after treatment with medicines to treat cancer.
Maltese: Cyramza jingħata flimkien ma' docetaxel, mediċina oħra kontra l-kanċer, għat-trattament ta' pazjenti adulti bi stadju avvanzat ta' kanċer tal-pulmun li l-marda tagħhom tkun marret għall-agħar wara trattament b'mediċini li jittrattaw il-kanċer.
English: For the
Maltese: OĦRA TAL
English: Table 12: Summary of efficacy data in REACH-2 - Intent to treat (ITT) population Cyramza N=197
Maltese: Tabella 12: Sommarju tad-dejta dwar l-effikaċja f'REACH-2 - Intenzjoni għat-trattament talpopolazzjoni (ITT)
English: A limited number of non-Caucasian, especially Black patients (2.6%) were included.
Maltese: Kawkasiċi, speċjalment pazjenti Suwed (2.6%).
English: e Includes: blood pressure increased, hypertension, and hypertensive cardiomyopathy.
Maltese: e Jinkludi: żieda fil-pressjoni tad-demm, ipertensjoni, u kardjomijopatija ipertensiva.
English: Common side effects (may affect up to 1 in 10 people): - fever accompanied by low white blood cell counts - low blood levels of a protein called albumin - infusion-related reactions - rash - redness, swelling, numbness/tingling, or pain and/or skin peeling in hands and/or feet (called hand-foot syndrome) - low blood levels of sodium (hyponatraemia) which can cause tiredness and confusion or muscle twitching - confusion and/or disorientation in patients with chronic liver problems - intestinal blockage; symptoms may include constipation and abdominal pain - abnormal growth of blood vessels - serious infection (sepsis) - low blood levels of potassium (hypokalaemia) which can cause muscle weakness, twitching or abnormal heart rhythm
Maltese: - tkabbir mhux normali fl-istrutturi tubulari li jġorru d-demm (arterji,vini jew kapillari) - infezzjoni serja (sepsi) - livelli baxxi ta' potassium fid-demm (ipokalimja) li jistgħu jikkawżaw dgħufija fil-muskoli,
English: There was an increase in median PFS of 1.2 months in favour of the Cyramza plus FOLFIRI arm: 5.7 months in the Cyramza plus FOLFIRI arm and 4.5 months in the placebo plus FOLFIRI arm. Efficacy results are shown in Table 10 and Figures 4 and 5.
Maltese: Kien hemm żieda ta' 1.2 xhur fil-medjan tal-PFS favur il-fergħa ta' Cyramza u FOLFIRI: 5.7 xhur fil-fergħa ta' Cyramza u FOLFIRI u 4.5 xhur fil-fergħa ta' plaċebo u FOLFIRI.
English: Tel: + 44-(0) 1256 315000
Maltese: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: The median OS in patients with any grade neutropenia was greater in the ramucirumab arm (16.1 months) than in the placebo arm (12.6 months).
Maltese: Il-medjan ta' OS f'pazjenti b'kwalunkwe grad ta' newtropinja kien ikbar filfergħa ta' ramucirumab (16.1 ta' xahar) milli fil-fergħa tal-plaċebo (12.6 ta' xahar).
English: You should avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Cyramza.
Maltese: Inti għandek tevita li tinqabad tqila waqt li tkun qed tieħu din il-mediċina u għal mill-inqas 3 xhur wara l-aħħar doża ta' Cyramza.
English: Depending on the protein level measured, Cyramza may be temporarily discontinued.
Maltese: Skont il-livell ta' proteina mkejla, Cyramza jista' jitwaqqaf b'mod temporanju.
English: In REVEL, the incidences of Grade ≥3 febrile neutropenia and hypertension were increased with higher ramucirumab exposure.
Maltese: F'REVEL, l-inċidenzi ta' newtropenija bid-deni u ipertensjoni ta' Grad ≥3 żdiedu ma' espożizzjoni ogħla għal ramucirumab.
English: There was an increase in median PFS of 1.5 months in favour of the Cyramza plus docetaxel arm: 4.5 months in the Cyramza plus docetaxel arm and 3 months in the placebo plus docetaxel arm. ORR was significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (22.9% vs. 13.6%, p<0.001).
Maltese: L-ORR (rispons sħiħ [CR - complete response] + rispons parzjali [PR - partial response]) tjieb b'mod sinifikanti f'pazjenti li kienu qed jirċievu Cyramza u docetaxel meta mqabbel ma' dawk li kienu qed jirċievu plaċebo u docetaxel (22.9% vs. 13.6%, p<0.001).
English: Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.
Maltese: Il-monoterapija b'Cyramza hija indikata għat-trattament f'pazjenti adulti b'karċinoma epatoċellulari avvanzata jew li mhijiex operabbli u li għandhom livell ta' fetoproteina alfa (AFP-alpha fetoprotein)
English: If you become pregnant during treatment with Cyramza, your doctor will discuss with you if the benefit of treatment for you is greater than any possible risk to you or your unborn baby.
Maltese: Qabel ma tirċievi Cyramza, jista' jkun li inti tingħata mediċina oħra biex tnaqqas ir-riskju ta'
English: Table 6: ADRs reported in patients treated with ramucirumab as monotherapy in phase 3 clinical trials (REGARD, REACH-2 and REACH patients with alpha fetoprotein ≥ 400 ng/ml)
Maltese: III (REGARD, REACH-2 u REACH pazjenti b'fetoproteina alfa ≥ 400 ng/ml)
English: - develop a blood clot in your arteries - develop a hole in the wall of your gut - experience severe bleeding - experience a severe infusion-related reaction - develop high blood pressure that cannot be controlled with medicine - are passing more than a certain amount of protein with your urine or if you develop a severe kidney disease (nephrotic syndrome) - develop abnormal tube-like connections or passageways inside the body between internal organs and skin or other tissues (fistula) - develop confusion and/or disorientation associated with chronic liver problems - decline in kidney function (in the setting of liver failure)
Maltese: - tiżviluppa pressjoni għolja li ma tistax tiġi kkontrollata bil-mediċina - qed tagħmel aktar minn ċertu ammont ta' proteina mal-awrina jew tiżviluppa mard qawwi tal kliewi (sindrome nefrotika)