FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: Post hoc ikke-stratificerede subgruppeanalyser af RAINBOW-patienter, som tidligere var behandlet med trastuzumab (n=39), tyder på en overlevelsesfordel for disse patienter (HR 0,679, 95 % Ki 0,327; 1,419), og viste en fordel mht. progressionsfri overlevelse (PFS) (HR 0,399, 95 % KI 0,194; 0,822).
English: Tel. +370 (5) 2649600
Danish: Eli Lilly Lietuva Tel. +370 (5) 2649600
English: No formal studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of ramucirumab.
Danish: Der er ikke udført formelle studier for at vurdere effekten af nedsat nyrefunktion på farmakokinetikken for ramucirumab.
English: Cyramza will be permanently stopped if you develop a fistula.
Danish: Behandlingen med Cyramza vil blive stoppet permanent, hvis du udvikler en fistel.
English: Name and address of the manufacturers of the biological active substance ImClone Systems LLC
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: There have been no formal studies with Cyramza in patients with hepatic impairment.
Danish: Der er ikke udført formelle studier med Cyramza hos patienter med nedsat leverfunktion.
English: Cyramza as a single agent The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
Danish: Cyramza som monoterapi Den anbefalede dosis af ramucirumab som monoterapi er 8 mg/kg hver anden uge.
English: Talk to your doctor or nurse immediately if any of the following applies to you (or you are not sure)
Danish: Du skal straks kontakte din læge eller sygeplejerske, hvis et eller flere af følgende punkter er relevante for dig (eller du er i tvivl) under behandlingen med Cyramza eller til enhver tid efterfølgende:
English: For recurrent Grade 2 stomatitis, reduce by 2 dose levels for 5-FU.
Danish: Ved tilbagevendende grad 2 stomatitis, reduceres med 2 dosisniveauer for 5-FU.
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.
Danish: RAINBOW, et globalt, randomiseret, dobbeltblindet studie med Cyramza plus paclitaxel versus placebo plus paclitaxel, blev udført med 665 patienter med lokalt recidiverende og ikke-resecerbar eller metastatisk gastrisk cancer (herunder GEJ adenokarcinom), efter platin- og fluorpyrimidinbaseret kemoterapi med eller uden antracyklin.
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.
Danish: Den anbefalede dosis af paclitaxel er 80 mg/m2 indgivet ved intravenøs infusion over ca. 60 minutter på dag 1, 8 og 15 i en 28-dages-serie.
English: Pack of 1 vial of 10 ml.
Danish: Pakning med 1 hætteglas med 10 ml.
English: Cyramza will be permanently stopped if you develop a blood clot in your arteries.
Danish: Behandlingen med Cyramza vil blive stoppet permanent, hvis du udvikler en blodprop i en arterie.
English: Table 3: Ramucirumab dose reductions for proteinuria Initial ramucirumab dose First dose reduction to Second dose reduction to
Danish: Tabel 3: Reduktion af ramucirumabdosis ved proteinuri
English: Ramucirumab should be immediately and permanently discontinued in the event of a grade 3 or 4 IRR (see section 4.4).
Danish: Ramucirumab skal straks seponeres permanent i tilfælde af en IRR af grad 3 eller 4 (se pkt.
English: In case of empty intravenous infusion container usage Aseptically transfer the calculated volume of ramucirumab into an empty intravenous infusion container.
Danish: Under aseptiske forhold overføres den beregnede mængde ramucirumab til den tomme intravenøse infusionsbeholder.
English: REGARD, a multinational, randomised, double-blind study of Cyramza plus BSC versus placebo plus BSC, was conducted in 355 patients with locally recurrent and unresectable, or metastatic gastric cancer (including GEJ adenocarcinoma) following platinum- or fluoropyrimidine-containing chemotherapy.
Danish: REGARD, et multinationalt, randomiseret, dobbeltblindet studie med Cyramza plus BSC versus placebo plus BSC, blev udført med 355 patienter med lokalt recidiverende og ikke-resecerbar, eller metastatisk gastrisk cancer (herunder GEJ-adenokarcinom), efter platin- eller fluorpyrimidin-baseret kemoterapi.
English: Median - months (95% CI)
Danish: Median - måneder (95 % KI)
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.
Danish: Cyramza gives i kombination med docetaxel, en anden kræftmedicin, til behandling af fremskreden lungekræft hos voksne, hvis sygdom er blevet værre efter behandling med medicin mod kræft.
English: Reduce by 1 dose level for 5-FU and irinotecan.
Danish: Reducer med 1 dosisniveau for 5-FU og irinotecan.
English: Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Danish: Bivirkningerne i hver hyppighedsgruppe er angivet således, at de mest alvorlige er anført først.
English: EU/1/14/957/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/957/003
English: No formal studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of ramucirumab.
Danish: Der er ikke udført formelle studier for at vurdere effekten af nedsat leverfunktion på farmakokinetikken for ramucirumab.
English: The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
Danish: Den anbefalede dosis af ramucirumab som monoterapi er 8 mg/kg hver anden uge.
English: Cyramza is given in combination with paclitaxel, another anti-cancer medicine, for the treatment of advanced stomach cancer (or cancer of the junction between the oesophagus and the stomach) in adults whose disease has worsened after treatment with medicines to treat cancer.
Danish: Cyramza gives i kombination med paclitaxel, en anden kræftmedicin, til behandling af fremskreden mavekræft (eller kræft i overgangen mellem spiserøret og mavesækken) hos voksne, hvis sygdom er blevet værre efter behandling med medicin mod kræft.
English: Ramucirumab therapy should be temporarily discontinued in the event of severe hypertension, until controlled with medical management.
Danish: Behandling med ramucirumab skal seponeres midlertidigt i tilfælde af svær hypertension, indtil denne er under kontrol ved hjælp af medicinsk behandling.
English: Hazard ratio (95% CI)
Danish: Hazard ratio (95% KI)
English: Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab
Danish: Cyramza 10 mg/ml koncentrat til infusionsvæske, opløsning ramucirumab
English: Ramucirumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding (see section 4.2).
Danish: Ramucirumab skal seponeres permanent hos patienter, som oplever blødning af grad 3 eller 4 (se pkt.
English: Paclitaxel at 80 mg/m2 was administered by intravenous infusion on days 1, 8, and 15 of each 28-day cycle.
Danish: Paclitaxel 80 mg/m2 blev administreret ved intravenøs infusion på dag 1, 8 og 15 i hver 28-dages serie.
English: Median (95% CI)
Danish: Median (95 % KI)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 50 ml vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - 50 ml hætteglas
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.
Danish: Der var en stigning i den mediane overlevelse på 2,3 måneder til fordel for Cyramza plus paclitaxel-gruppen: 9,63 måneder i Cyramza plus paclitaxel-gruppen og 7,36 måneder i placebo plus paclitaxel-gruppen.
English: Do not freeze or shake the infusion solution.
Danish: Infusionsopløsningen må ikke nedfryses eller rystes.
English: Haematological criteria in Table 2 are met
Danish: De hæmatologiske kriterier i tabel 2 er opnået
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.
Danish: Progressionsfri overlevelse var statistisk signifikant forbedret hos patienter, som fik Cyramza sammenlignet med patienter, som fik placebo (hazard ratio [HR] 0,483; 95 % KI: 0,376 til 0,620; p= 0,0001), svarende til en reduktion på 52 % i risikoen for progression eller død og en stigning i den mediane progressionsfri overlevelse til 2,1 måneder for Cyramza fra 1,3 måneder for placebo.
English: Overall survival was statistically significantly improved in patients receiving Cyramza as compared with patients receiving placebo (hazard ratio [HR] 0.776; 95%CI: 0.603 to 0.998; p= 0.0473), corresponding to a 22% reduction in the risk of death and an increase in median survival to 5.2 months for Cyramza from3.8 months for placebo.
Danish: Den samlede overlevelse var statistisk signifikant forbedret hos de patienter, som fik Cyramza sammenlignet med de patienter, som fik placebo (hazard ratio [HR] 0,776; 95 % KI: 0,603 til 0,998; p= 0,0473), svarende til en reduktion på 22 % i risikoen for død og en stigning i den mediane overlevelse til 5,2 måneder for Cyramza fra 3,8 måneder for placebo.
English: g Based on study RAISE (ramucirumab plus FOLFIRI).
Danish: g Baseret på RAISE studiet (ramucirumab plus FOLFIRI).
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.
Danish: HR for OS var 0,86 (95 % KI: 0,73-1,01) for patienter med TTP ≥ 6 måneder efter påbegyndelse af førstelinjebehandling var og 0,86 (95 % KI: 0,64-1,13) for patienter med TTP < 6 måneder efter påbegyndelse af førstelinjebehandling.
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).
Danish: Behandling med ramucirumab skal permanent seponeres i tilfælde af urinproteinniveauer på >3 g/24 timer og i tilfælde af nefrotisk syndrom (se pkt.
English: Haematological criteria in Table 2 are met and fever resolved
Danish: De hæmatologiske kriterier i tabel 2 er opnået, og feber er ophørt
English: An increased incidence of severe hypertension was reported in patients receiving ramucirumab as compared to placebo.
Danish: En øget incidens af svær hypertension blev rapporteret hos patienter, som fik ramucirumab, sammenlignet med placebo.
English: The patient should be monitored during infusion for signs of infusion-related reactions (see section 4.4) and the availability of appropriate resuscitation equipment should be ensured.
Danish: Patienten skal monitoreres under infusionen for tegn på infusionsrelaterede reaktioner (se pkt.
English: In RAINBOW, the incidences of Grade ≥3 hypertension, neutropenia, and leukopenia were increased with higher ramucirumab exposure.
Danish: I RAINBOW-studiet var der hyppigere forekomst af grad ≥3 hypertension, neutropeni og leukopeni ved øget ramucirumabeksponering.
English: 18.3-123 μg/ml), respectively.
Danish: 13,8-234 μg/ml).
English: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≥2 patients Patients with ECOG score ≥2 were excluded from the pivotal studies in all indications, therefore the safety and efficacy of Cyramza in this patient population is unknown.
Danish: Patienter med ECOG-score ≥2 blev ekskluderet fra de pivotale studier for alle indikationer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 10 ml vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - 10 ml hætteglas
English: d Based on study REVEL (ramucirumab plus docetaxel).
Danish: d Baseret på REVEL studiet (ramucirumab plus docetaxel).
English: Gastrointestinal perforations (see section 4.4).
Danish: Gastrointestinale perforationer (se pkt.
English: Cyramza will be permanently stopped if you develop a hole in the wall of your gut.
Danish: Behandlingen med Cyramza vil blive stoppet permanent, hvis du udvikler et hul i tarmvæggen.
English: Ramucirumab should be immediately and permanently discontinued in patients who experience a Grade 3 or 4 IRR (see section 4.2).
Danish: Ramucirumab skal seponeres straks og permanent hos patienter, som oplever IRR af grad 3 eller 4 (se pkt.
English: ORR % (95% CI) p-value Abbreviations: CI = confidence interval, CR = complete response, ORR = objective response rate and PR = partial response
Danish: Forkortelser: KI = konfidensinterval, CR = komplet respons, ORR = objektiv responsrate og PR = partiel respons.
English: i Based on study RAINBOW (ramucirumab plus paclitaxel) and study REVEL (ramucirumab plus docetaxel).
Danish: i Baseret på RAINBOW studiet (ramucirumab plus paclitaxel) og REVEL studiet (ramucirumab plus docetaxel).
English: Female fertility is likely to be compromised during treatment with ramucirumab based on studies in animals (see section 5.3).
Danish: Dyreforsøg har vist, at den kvindelige fertilitet sandsynligvis vil blive påvirket under behandling med ramucirumab (se pkt.
English: Figure 8: Kaplan-Meier curves of Overall Survival for Cyramza versus placebo in REACH-2
Danish: Figur 8: Kaplan-Meier kurver for samlet overlevelse for Cyramza versus placebo i REACH-2
English: Efficacy results are shown in Table 11.
Danish: Effektdata er vist i tabel 11.
English: For recurrent Grade 2 diarrhoea, reduce by 1 dose level for 5-FU and irinotecan.
Danish: Ved tilbagevendende grad 2 diarré, reduceres med 1 dosisniveau for 5-FU og irinotecan.
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)
Danish: Ved dosisregimet med 10 mg/kg ramucirumab hver 3. uge i kombination med docetaxel var de geometriske middelværdier af ramucirumab-Cmin i serum fra patienter med NSCLC henholdsvis 28,3 μg/ml (interval 2,5-108 μg/ml) og 38,4 μg/ml (interval 3,1-128 μg/ml) inden administration af den 3. og 5. dosis ramucirumab.
English: One ml of concentrate for solution for infusion contains 10 mg ramucirumab.
Danish: Én ml koncentrat til infusionsvæske, opløsning indeholder 10 mg ramucirumab.
English: Cyramza is used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults.
Danish: Cyramza bruges til behandling af fremskreden kræft i tyktarmen eller endetarmen hos voksne.
English: Cyramza 10 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Cyramza 10 mg/ml koncentrat til infusionsvæske, opløsning
English: EU/1/14/957/001 - 1 vial of 10 ml.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/957/001 - 1 hætteglas med 10 ml.
English: Following the dose regimen of 8 mg/kg every 2 weeks, the geometric means of ramucirumab Cmin prior to administration of the fourth and seventh dose of ramucirumab given as a single agent in advanced gastric cancer patients' serum were 49.5 μg/ml (range of 6.3-228 μg/ml) and 74.4 μg/ml (range of 13.8-234 μg/ml), respectively.
Danish: Efter dosisregimet med 8 mg/kg hver anden uge var de geometriske middelværdier for ramucirumab Cmin i serum, inden administration af den 4. og 7. dosis ramucirumab givet som monoterapi, ved fremskreden gastrisk cancer henholdsvis 49,5 μg/ml (interval 6,3-228 μg/ml) og 74,4 μg/ml (interval
English: Concentrate for solution for infusion 500 mg/50 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 500 mg/50 ml
English: Paclitaxel and docetaxel are also given by a drip into a vein (intravenous infusion) over a period of approximately 60 minutes.
Danish: Når du får Cyramza i kombination med paclitaxel eller docetaxel Paclitaxel og docetaxel gives også ind i en vene via et drop (intravenøs infusion) over et tidsrum på ca. 60 minutter.
English: Reduce by 2 dose levels for 5-FU and irinotecan.
Danish: Reducer med 2 dosisniveauer for 5-FU og irinotecan.
English: Days 8 and 15: ≥75 x 109/L
Danish: Dag 1: ≥ 100 x 109/l Dag 8 og 15: ≥ 75 x 109/l
English: Also, patients receiving any kind of therapeutic anticoagulation and/or chronic therapy with non-steroidal anti-inflammatory drugs or other antiplatelets agents or those with untreated, clinically unstable brain/CNS metastases were excluded Aspirin use at doses up to 325 mg/day was permitted.
Danish: Patienter, som var i enhver form for terapeutisk antikoagulationsbehandling og/eller i kronisk behandling med nonsteroide anti-inflammatoriske lægemidler eller andre trombocytfunktionshæmmende midler, og patienter med ubehandlede, klinisk ustabile hjerne/CNSmetastaser blev også ekskluderet.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - 10 ml vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET - 10 ml hætteglas
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - 50 ml vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET - 50 ml hætteglas
English: For patients with NSCLC, ramucirumab is contraindicated where there is tumour cavitation or tumour involvement of major vessels (see section 4.4).
Danish: Ramucirumab er kontraindiceret til patienter med NSCLC, hvor der er tumorkavitation, eller hvor tumor involverer større blodkar (se pkt.
English: Symptoms include severe abdominal pain, being sick (vomiting), fever or chills.
Danish: Symptomerne omfatter alvorlige mavesmerter, opkastning, feber eller kulderystelser.
English: Tel. + 49-(0) 6172 273 2222
Danish: Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222
English: Baseline patient demographics and disease characteristics were generally balanced between arms: the median age was 61 years; 71% of patients were male; 61% were Caucasian, 35% Asian; the ECOG PS was 0 for 39% of patients, 1 for
Danish: Baseline-patientdemografi og sygdomskarakteristika var generelt balanceret mellem grupperne: den mediane alder var 61 år, 71 % af patienterne var mænd, 61 % var kaukasere, 35 % var asiater, ECOG PS var 0 for 39 % af patienterne og 1 for 61 % af patienterne, 81 % af patienterne havde målbar sygdom, 79 % af patienterne havde gastrisk cancer, mens 21 % havde adenokarcinom i den gastroøsofagale overgang (GEJ).
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
Danish: Der blev ikke observeret forskelle i effekten mellem de 2 behandlingsarme i subgrupperne af patienter ≥65 år (OS HR 1,10, 95 % KI: 0,89-1,36; median OS [mOS]: 9,2 vs 9,3 måneder, se pkt.
English: f Based on study RAINBOW (ramucirumab plus paclitaxel) and study RAISE (ramucirumab plus FOLFIRI).
Danish: f Baseret på RAINBOW studiet (ramucirumab plus paclitaxel) og RAISE studiet (ramucirumab plus FOLFIRI).
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs brug efter fortynding.
English: If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Danish: Hvis diarré er bedret til grad ≤1, reduceres med 1 dosisniveau for 5-FU.
English: There are no data regarding ramucirumab administration in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Der foreligger ingen data om behandling med ramucirumab hos patienter med svært nedsat leverfunktion (se pkt.
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.
Danish: Seponer 5-FU i højst 28* dage indtil restitution til grad ≤1, herefter reduceres dosis med 2 niveauer for 5-FU.
English: Hazard ratio (95% CI) Stratified log-rank p-value 12-week PFS rate% (95% CI) Abbreviations: CI = confidence interval
Danish: Stratificeret log-rank p-værdi 12-ugers PFS-rate % (95 % KI)
English: Criteria to be met prior to FOLFIRI are provided in Table 2.
Danish: Tabel 2 angiver de kriterier, som skal opfyldes inden FOLFIRI.
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).
Danish: Cyramza i kombination med paclitaxel er indiceret til behandling af voksne patienter med fremskreden gastrisk cancer eller adenokarcinom i den gastroøsofagale overgang med sygdomsprogression efter tidligere platin- og fluorpyrimidinbaseret kemoterapi (se pkt.
English: Ramucirumab should be permanently discontinued in patients who experience a severe ATE (see section 4.2).
Danish: Ramucirumab skal seponeres permanent hos patienter, som oplever en svær ATE (se pkt.
English: Tel: + 46-(0) 8 7378800
Danish: Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800
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).
Danish: OS var statistisk signifikant bedre hos de patienter, der fik Cyramza plus docetaxel, sammenlignet med dem, som fik placebo plus docetaxel (HR 0,857; 95 % KI: 0,751-0,979; p=0,024).
English: c Based on study RAINBOW (ramucirumab plus paclitaxel).
Danish: c Baseret på RAINBOW studiet (ramucirumab plus paclitaxel).
English: An increased incidence of proteinuria was reported in patients receiving ramucirumab as compared to placebo.
Danish: Der er rapporteret om en øget forekomst af proteinuri hos patienter i behandling med ramucirumab sammenlignet med placebo.
English: Overall survival was statistically significantly improved in patients receiving Cyramza plus FOLFIRI compared with those receiving placebo plus FOLFIRI (HR 0.844; 95% CI: 0.730 to 0.976; p=0.0219).
Danish: Den samlede overlevelse var statistisk signifikant bedre hos de patienter, der fik Cyramza plus FOLFIRI, sammenlignet med dem, der fik placebo plus FOLFIRI (HR 0,844; 95 % KI: 0,730-0,976; p=0,0219).
English: Concentrate for solution for infusion 100 mg/10 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 100 mg/10 ml
English: In REVEL, the incidences of Grade ≥3 febrile neutropenia and hypertension were increased with higher ramucirumab exposure.
Danish: I REVEL-studiet var der hyppigere forekomst af grad ≥3 febril neutropeni og hypertension ved øget ramucirumabeksponering.
English: b Based on study RAINBOW (ramucirumab plus paclitaxel).
Danish: b Baseret på RAINBOW studiet (ramucirumab plus paclitaxel).
English: Baseline patient demographics and disease characteristics were generally balanced between arms: the median age was 62 years; 67% of patients were male; 82% were Caucasian, 13% Asian; the ECOG PS
Danish: Patienternes demografi og sygdomskarakteristika ved baseline var generelt velbalanceret mellem armene: Medianalderen var 62 år, 67 % af patienterne var mænd, 82 % var kaukasiere, 13 % asiater; ECOG-PS var 0 for 32 % af patienterne og 1 for 67 % af patienterne, 73 % af patienterne havde ikkeplanocellulær histologi, og 26 % havde planocellulær histologi.
English: Figure 7: Kaplan-Meier curves of progression-free survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Danish: Figur 7: Kaplan-Meier-kurver for progressionsfri overlevelse for Cyramza plus docetaxel versus placebo plus docetaxel i REVEL
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”).
Danish: - Øvrige indholdsstoffer: histidin, histidinhydrochlorid, natriumchlorid, glycin (E640), polysorbat