natgillin/translations-raw huggingface dataset:
Tabel 3: Reduktion af ramucirumabdosis ved proteinuri
Table 3: Ramucirumab dose reductions for proteinuria Initial ramucirumab dose First dose reduction to Second dose reduction to
Ramucirumab skal straks seponeres permanent i tilfælde af en IRR af grad 3 eller 4 (se pkt.
Ramucirumab should be immediately and permanently discontinued in the event of a grade 3 or 4 IRR (see section 4.4).
Under aseptiske forhold overføres den beregnede mængde ramucirumab til den tomme intravenøse infusionsbeholder.
In case of empty intravenous infusion container usage Aseptically transfer the calculated volume of ramucirumab into an empty intravenous infusion container.
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.
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.
Median - måneder (95 % KI)
Median - months (95% CI)
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.
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.
Reducer med 1 dosisniveau for 5-FU og irinotecan.
Reduce by 1 dose level for 5-FU and irinotecan.
Bivirkningerne i hver hyppighedsgruppe er angivet således, at de mest alvorlige er anført først.
Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/957/003
EU/1/14/957/003
Der er ikke udført formelle studier for at vurdere effekten af nedsat leverfunktion på farmakokinetikken for ramucirumab.
No formal studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of ramucirumab.
Den anbefalede dosis af ramucirumab som monoterapi er 8 mg/kg hver anden uge.
The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
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.
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.
Behandling med ramucirumab skal seponeres midlertidigt i tilfælde af svær hypertension, indtil denne er under kontrol ved hjælp af medicinsk behandling.
Ramucirumab therapy should be temporarily discontinued in the event of severe hypertension, until controlled with medical management.
Hazard ratio (95% KI)
Hazard ratio (95% CI)
Cyramza 10 mg/ml koncentrat til infusionsvæske, opløsning ramucirumab
Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab
Ramucirumab skal seponeres permanent hos patienter, som oplever blødning af grad 3 eller 4 (se pkt.
Ramucirumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding (see section 4.2).
Paclitaxel 80 mg/m2 blev administreret ved intravenøs infusion på dag 1, 8 og 15 i hver 28-dages serie.
Paclitaxel at 80 mg/m2 was administered by intravenous infusion on days 1, 8, and 15 of each 28-day cycle.
Median (95 % KI)
Median (95% CI)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - 50 ml hætteglas
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 50 ml vial
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.
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.
Infusionsopløsningen må ikke nedfryses eller rystes.
Do not freeze or shake the infusion solution.
De hæmatologiske kriterier i tabel 2 er opnået
Haematological criteria in Table 2 are met
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.
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.
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.
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.
g Baseret på RAISE studiet (ramucirumab plus FOLFIRI).
g Based on study RAISE (ramucirumab plus FOLFIRI).
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.
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.
Behandling med ramucirumab skal permanent seponeres i tilfælde af urinproteinniveauer på >3 g/24 timer og i tilfælde af nefrotisk syndrom (se pkt.
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).
De hæmatologiske kriterier i tabel 2 er opnået, og feber er ophørt
Haematological criteria in Table 2 are met and fever resolved
En øget incidens af svær hypertension blev rapporteret hos patienter, som fik ramucirumab, sammenlignet med placebo.
An increased incidence of severe hypertension was reported in patients receiving ramucirumab as compared to placebo.
Patienten skal monitoreres under infusionen for tegn på infusionsrelaterede reaktioner (se pkt.
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.
I RAINBOW-studiet var der hyppigere forekomst af grad ≥3 hypertension, neutropeni og leukopeni ved øget ramucirumabeksponering.
In RAINBOW, the incidences of Grade ≥3 hypertension, neutropenia, and leukopenia were increased with higher ramucirumab exposure.
13,8-234 μg/ml).
18.3-123 μg/ml), respectively.
Patienter med ECOG-score ≥2 blev ekskluderet fra de pivotale studier for alle indikationer.
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.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON - 10 ml hætteglas
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 10 ml vial
d Baseret på REVEL studiet (ramucirumab plus docetaxel).
d Based on study REVEL (ramucirumab plus docetaxel).
Gastrointestinale perforationer (se pkt.
Gastrointestinal perforations (see section 4.4).
Behandlingen med Cyramza vil blive stoppet permanent, hvis du udvikler et hul i tarmvæggen.
Cyramza will be permanently stopped if you develop a hole in the wall of your gut.
Ramucirumab skal seponeres straks og permanent hos patienter, som oplever IRR af grad 3 eller 4 (se pkt.
Ramucirumab should be immediately and permanently discontinued in patients who experience a Grade 3 or 4 IRR (see section 4.2).
Forkortelser: KI = konfidensinterval, CR = komplet respons, ORR = objektiv responsrate og PR = partiel respons.
ORR % (95% CI) p-value Abbreviations: CI = confidence interval, CR = complete response, ORR = objective response rate and PR = partial response
i Baseret på RAINBOW studiet (ramucirumab plus paclitaxel) og REVEL studiet (ramucirumab plus docetaxel).
i Based on study RAINBOW (ramucirumab plus paclitaxel) and study REVEL (ramucirumab plus docetaxel).
Dyreforsøg har vist, at den kvindelige fertilitet sandsynligvis vil blive påvirket under behandling med ramucirumab (se pkt.
Female fertility is likely to be compromised during treatment with ramucirumab based on studies in animals (see section 5.3).
Figur 8: Kaplan-Meier kurver for samlet overlevelse for Cyramza versus placebo i REACH-2
Figure 8: Kaplan-Meier curves of Overall Survival for Cyramza versus placebo in REACH-2
Effektdata er vist i tabel 11.
Efficacy results are shown in Table 11.
Ved tilbagevendende grad 2 diarré, reduceres med 1 dosisniveau for 5-FU og irinotecan.
For recurrent Grade 2 diarrhoea, reduce by 1 dose level for 5-FU and irinotecan.
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.
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)
Én ml koncentrat til infusionsvæske, opløsning indeholder 10 mg ramucirumab.
One ml of concentrate for solution for infusion contains 10 mg ramucirumab.
Cyramza bruges til behandling af fremskreden kræft i tyktarmen eller endetarmen hos voksne.
Cyramza is used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults.
LÆGEMIDLETS NAVN Cyramza 10 mg/ml koncentrat til infusionsvæske, opløsning
Cyramza 10 mg/ml concentrate for solution for infusion
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/957/001 - 1 hætteglas med 10 ml.
EU/1/14/957/001 - 1 vial of 10 ml.
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
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.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 500 mg/50 ml
Concentrate for solution for infusion 500 mg/50 ml
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.
Paclitaxel and docetaxel are also given by a drip into a vein (intravenous infusion) over a period of approximately 60 minutes.
Reducer med 2 dosisniveauer for 5-FU og irinotecan.
Reduce by 2 dose levels for 5-FU and irinotecan.
Dag 1: ≥ 100 x 109/l Dag 8 og 15: ≥ 75 x 109/l
Days 8 and 15: ≥75 x 109/L
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.
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.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET - 10 ml hætteglas
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - 10 ml vial
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET - 50 ml hætteglas
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - 50 ml vial
Ramucirumab er kontraindiceret til patienter med NSCLC, hvor der er tumorkavitation, eller hvor tumor involverer større blodkar (se pkt.
For patients with NSCLC, ramucirumab is contraindicated where there is tumour cavitation or tumour involvement of major vessels (see section 4.4).
Symptomerne omfatter alvorlige mavesmerter, opkastning, feber eller kulderystelser.
Symptoms include severe abdominal pain, being sick (vomiting), fever or chills.
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).
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
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.
≥65 years old (OS HR 1.10, 95% CI: 0.89, 1.36; median OS [mOS]: 9.2 vs 9.3 months, see section
f Baseret på RAINBOW studiet (ramucirumab plus paclitaxel) og RAISE studiet (ramucirumab plus FOLFIRI).
f Based on study RAINBOW (ramucirumab plus paclitaxel) and study RAISE (ramucirumab plus FOLFIRI).
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs brug efter fortynding.
METHOD AND ROUTE(S) OF ADMINISTRATION
Hvis diarré er bedret til grad ≤1, reduceres med 1 dosisniveau for 5-FU.
If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Der foreligger ingen data om behandling med ramucirumab hos patienter med svært nedsat leverfunktion (se pkt.
There are no data regarding ramucirumab administration in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Seponer 5-FU i højst 28* dage indtil restitution til grad ≤1, herefter reduceres dosis med 2 niveauer for 5-FU.
Withhold 5-FU for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 dose levels for 5-FU.
Stratificeret log-rank p-værdi 12-ugers PFS-rate % (95 % KI)
Hazard ratio (95% CI) Stratified log-rank p-value 12-week PFS rate% (95% CI) Abbreviations: CI = confidence interval
Tabel 2 angiver de kriterier, som skal opfyldes inden FOLFIRI.
Criteria to be met prior to FOLFIRI are provided in Table 2.
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.
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).
Ramucirumab skal seponeres permanent hos patienter, som oplever en svær ATE (se pkt.
Ramucirumab should be permanently discontinued in patients who experience a severe ATE (see section 4.2).
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).
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).
c Baseret på RAINBOW studiet (ramucirumab plus paclitaxel).
c Based on study RAINBOW (ramucirumab plus paclitaxel).
Der er rapporteret om en øget forekomst af proteinuri hos patienter i behandling med ramucirumab sammenlignet med placebo.
An increased incidence of proteinuria was reported in patients receiving ramucirumab as compared to placebo.
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).
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).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 100 mg/10 ml
Concentrate for solution for infusion 100 mg/10 ml
I REVEL-studiet var der hyppigere forekomst af grad ≥3 febril neutropeni og hypertension ved øget ramucirumabeksponering.
In REVEL, the incidences of Grade ≥3 febrile neutropenia and hypertension were increased with higher ramucirumab exposure.
b Baseret på RAINBOW studiet (ramucirumab plus paclitaxel).
b Based on study RAINBOW (ramucirumab plus paclitaxel).
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.
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
Figur 7: Kaplan-Meier-kurver for progressionsfri overlevelse for Cyramza plus docetaxel versus placebo plus docetaxel i REVEL
Figure 7: Kaplan-Meier curves of progression-free survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
- Øvrige indholdsstoffer: histidin, histidinhydrochlorid, natriumchlorid, glycin (E640), polysorbat
- The other ingredients are histidine, histidine monohydrochloride, sodium chloride, glycine (E640), polysorbate 80 (E433) and water for injections (see section 2 “Cyramza contains sodium”).
Samlet overlevelse var statistisk signifikant bedre hos de patienter, som fik Cyramza plus paclitaxel, sammenlignet med dem, som fik placebo plus paclitaxel (HR 0,807; 95 % KI: 0,678 til 0,962; p=0,0169).
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).
Figur 6: Kaplan-Meier-kurver for samlet overlevelse for Cyramza plus docetaxel versus placebo plus docetaxel i REVEL
Figure 6: Kaplan-Meier curves of overall survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Figur 3: Kaplan-Meier-kurver for samlet overlevelse for Cyramza versus placebo i REGARD
Figure 3: Kaplan-Meier curves of overall survival for Cyramza versus placebo in REGARD
I RAISE-studiet var der hyppigere forekomst af grad ≥3 neutropeni ved øget ramucirumabeksponering.
In RAISE, the incidence of Grade ≥3 neutropenia was increased with higher ramucirumab exposure.
Day 1: ≥ 1,5 x 109/l Dag 8 og 15: ≥ 1,0 x 109/l
Days 8 and 15: ≥1.0 x 109/L
Udskyd 5-FU og irinotecan i højst 28* dage indtil restitution til grad ≤1, herefter reduceres dosis med 1 niveau for 5-FU og irinotecan.
Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 1 level for 5-FU and irinotecan.
Figur 4: Kaplan-Meier-kurver for samlet overlevelse for Cyramza plus FOLFIRI versus placebo plus FOLFIRI i RAISE
Figure 4: Kaplan-Meier curves of overall survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
- Hvert 50 ml hætteglas indeholder 500 mg ramucirumab.
- Each 50 ml vial contains 500 mg of ramucirumab.
Udslæta
Fistula
- Hvert 10 ml hætteglas indeholder 100 mg ramucirumab.
- Each 10 ml vial contains 100 mg of ramucirumab.
Cyramza er indiceret som monoterapi til behandling af voksne patienter med fremskreden gastrisk cancer eller adenokarcinom i den gastroøsofagale overgang (GEJ) med sygdomsprogression efter tidligere platin- eller fluorpyrimidinbaseret kemoterapi, for hvem behandling med paclitaxel ikke er hensigtsmæssig.
Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).
brug efter fortynding.
For IV use after dilution.
Figur 2: Kaplan-Meier-kurver for progressionsfri overlevelse for Cyramza plus paclitaxel versus placebo plus paclitaxel i RAINBOW
Figure 2: Kaplan-Meier curves of progression-free survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Figur 1: Kaplan-Meier-kurver for samlet overlevelse for Cyramza plus paclitaxel versus placebo plus paclitaxel i RAINBOW
Figure 1: Kaplan-Meier curves of overall survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Udskyd 5-FU og irinotecan i højst 28* dage indtil restitution til grad ≤1, herefter reduceres dosis med 2 niveauer for 5-FU og irinotecan.
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.
Hvert 50 ml hætteglas indeholder 500 mg ramucirumab.
Each 50 ml vial contains 500 mg of ramucirumab.
Hvert 10 ml hætteglas indeholder 100 mg ramucirumab.
Each 10 ml vial contains 100 mg of ramucirumab.
Ramucirumab skal seponeres permanent hos patienter, som udvikler fistler (se pkt.
Ramucirumab treatment should be discontinued in patients who develop fistula (see section 4.2).
Justering af paclitaxeldosis
Paclitaxel dose adjustments
Arterielle tromboemboliske hændelsera
Arterial thromboembolic eventsa
Dosisjustering af FOLFIRI
FOLFIRI dose adjustments
Hvis diarré er bedret til grad ≤1, reduceres med 1 dosisniveau for 5-FU og irinotecan.
If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU and irinotecan.
Der var en øget median PFS på 1,2 måneder til fordel for Cyramza plus FOLFIRI: 5,7 måneder i Cyramza plus FOLFIRI-armen og 4,5 måneder i placebo plus FOLFIRI-armen.
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.
Der var en stigning i den mediane progressionsfri overlevelse (PFS) på 1,5 måneder til fordel for Cyramza plus paclitaxel-gruppen: 4,4 måneder i Cyramza plus paclitaxel-gruppen og 2,9 måneder i placebo plus paclitaxel-gruppen.
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.
Stratificeret log-rank p-værdi Forkortelser: KI = Konfidensinterval
Hazard ratio (95% CI) Stratified log-rank p-value Abbreviations: CI = confidence interval
Første dosisreduktion til
Initial dose