FrancophonIA/ELRC3.0 huggingface dataset:
English: Ramucirumab is an antiangiogenic therapy and may increase the risk of gastrointestinal perforations.
Danish: Ramucirumab er en antiangiogen behandling, som kan øge risikoen for gastrointestinale perforationer.
English: Chemical and physical in-use stability of Cyramza in sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 24 hours at 2 ºC to 8 ºC or for 4 hours at 25 ºC.
Danish: Der er påvist kemisk og fysisk stabilitet under brug af Cyramza i natriumchloridinjektionsvæske 9 mg/ml (0,9 %) i et tidsrum på 24 timer ved 2 ºC til 8 ºC eller i 4 timer ved 25 ºC.
English: - if you are allergic to ramucirumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Cyramza - hvis du er allergisk over for ramucirumab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Ramucirumab therapy should be temporarily discontinued for at least 4 weeks prior to elective surgery.
Danish: Behandling med ramucirumab skal seponeres midlertidigt i mindst 4 uger inden elektiv kirurgi.
English: The pharmacokinetics of irinotecan and its active metabolite, SN-38, were not affected when co-administered with ramucirumab.
Danish: Farmakokinetikken for irinotecan og den aktive metabolit, SN-38, blev ikke påvirket ved samtidig administration af ramucirumab.
English: Docetaxel dose reductions may be applied based upon the grade of toxicity experienced by the patient.
Danish: Docetaxeldosis kan reduceres afhængigt af den toksicitetsgrad, som patienten oplever.
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).
Danish: Hyppigheden af sygdomskontrol (komplet respons plus partiel respons plus stabil sygdom) var numerisk højere i ramucirumab plus FOLFIRIarmen sammenlignet med placebo plus FOLFIRI-armen (henholdsvis 74,1 % versus 68,8 %).
English: A treatment effect on PFS was observed for all exposure levels produced by 8 mg/kg ramucirumab given every 2 weeks.
Danish: En behandlingseffekt på PFS blev observeret for alle eksponeringsniveauer ved administration af 8 mg/kg ramucirumab givet hver anden uge.
English: The remainder (25%) received prior platinum and fluoropyrimidine combination therapy with anthracycline.
Danish: Resten (25 %) havde tidligere fået platin- og fluorpyrimidin-kombinationsbehandling med antracyklin.
English: Table 1: Criteria to be met prior to each paclitaxel administration Criteria
Danish: Tabel 1: Kriterier, som skal opfyldes inden hver indgift af paclitaxel
English: Severe bleeding: NCI CTCAE Grade 3 or 4 bleeding (see section 4.4).
Danish: Svær blødning: Blødning af NCI CTCAE-grad 3 eller 4 (se pkt.
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.
Danish: Patienter blev også ekskluderet, hvis de havde haft en af følgende: en ATE, grad 4 hypertension, grad 3 proteinuri, en grad 3-4 blødningshændelse eller tarmperforation under førstelinjebehandling med bevacizumab.
English: For HCC patients with evidence of portal hypertension or prior history of oesophageal variceal bleeding, screening for and treatment of oesophageal varices should be performed as per standard of care before starting ramucirumab treatment.
Danish: For HCC-patienter med tegn på portal hypertension eller blødende øsofageale varicer i anamnesen, skal screening og behandling af øsofageale varicer udføres i henhold til gældende standarder inden opstart med ramucirumab.
English: - A hole in the wall of your gut (‘gastrointestinal perforation'): Cyramza may increase the risk of developing a hole in the wall of your gut.
Danish: - Et hul i tarmvæggen ("gastrointestinal perforation"): Cyramza kan øge risikoen for, at man udvikler et hul i tarmvæggen.
English: Neutropenia or Thrombocytopenia
Danish: Neutropeni eller trombocytopeni
English: As a risk to breast-fed newborns/infants cannot be excluded, breast-feeding should be discontinued during treatment with Cyramza and for at least 3 months after the last dose.
Danish: Da det ikke kan udelukkes, at der er en risiko for nyfødte/spædbørn der ammes, skal amning stoppes under behandling med Cyramza og i mindst 3 måneder efter den sidste dosis.
English: There are limited data available about the use of Cyramza in patients with severely impaired kidney function.
Danish: Der er begrænsede data tilgængelige om brug af Cyramza hos patienter med alvorligt nedsat nyrefunktion.
English: Renal and urinary disorders Proteinuriaa,h General disorders and administration site disorders
Danish: Nyrer og urinveje Proteinuria,f Almene symptomer og reaktioner på administrationssted et
English: e Includes: blood pressure increased, hypertension, and hypertensive cardiomyopathy.
Danish: e Dette omfatter: blodtryksstigning, hypertension og hypertensiv kardiomyopati.
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.
Danish: Ramucirumab skal anvendes med forsigtighed hos patienter med svær levercirrose (Child-Pugh B eller C), cirrose med hepatisk encephalopati, klinisk signifikant ascites forårsaget af cirrose eller hepatorenalt syndrom.
English: Exposure response relationships
Danish: Eksponering/respons-sammenhæng
English: - The active substance is ramucirumab.
Danish: - Aktivt stof: ramucirumab.
English: Cyramza is administered as an intravenous infusion.
Danish: Cyramza administreres som en intravenøs infusion.
English: Cases of gastrointestinal perforation have been reported in patients treated with ramucirumab.
Danish: Der er indberettet tilfælde af gastrointestinal perforation hos patienter behandlet med ramucirumab.
English: Terminology Criteria for Adverse Events [NCI
Danish: ≤ grad 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE])
English: - Severe bleeding: Cyramza may increase the risk of severe bleeding.
Danish: - Alvorlig blødning: Cyramza kan øge risikoen for alvorlig blødning.
English: Ramucirumab has not been studied in patients with severe hepatic impairment (total bilirubin >3.0 ULN and any AST).
Danish: Ramucirumab er ikke undersøgt hos patienter med svært nedsat leverfunktion (total-bilirubin > 3,0 gange ULN og enhver ASAT).
English: The FOLFIRI regimen was: irinotecan 180 mg/m2 administered over 90 minutes and folinic acid 400 mg/m2 administered, simultaneously over 120 minutes; followed by bolus 5-fluorouracil(5-FU) 400 mg/m2 over 2 to 4 minutes; followed by 5-FU 2400 mg/m2 administered by continuous infusion over 46 to 48 hours.
Danish: FOLFIRI-regimet var: Irinotecan 180 mg/m2 administreret over 90 minutter og folinsyre 400 mg/m2 administreret samtidigt over 120 minutter, efterfulgt af bolus fluoruracil (5-FU) 400 mg/m2 over 2-4 minutter og efterfulgt af 5-FU 2.400 mg/m2 administreret ved kontinuerlig infusion over 46-48 timer.
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.
Danish: Derudover var patienterne enten Barcelona Clinic Liver Cancer (BCLC) stadie B samt ikke længere egnede til lokalregional terapi eller BCLC stadie C. Patienter med hjernemetastaser, leptomeningeal sygdom, ukontrolleret rygmarvskompression, tidligere eller nuværende hepatisk encefalopati eller klinisk relevant ascites, alvorlig variceblødning i løbet af 3 måneder før behandling, eller gastriske- eller øsofageale varicer med høj risiko for blødning blev ekskluderet fra studiet.
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.
Danish: Svær gastrointestinal blødning, herunder dødelige hændelser, blev rapporteret hos patienter med gastrisk cancer, som blev behandlet med ramucirumab i kombination med paclitaxel, og hos patienter med mCRC, som blev behandlet med ramucirumab i kombination med FOLFIRI.
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).
Danish: Patienter med HCC skal udvælges på basis af serum AFP koncentration ≥ 400 ng/ml ved anvendelse af en valideret AFP test før behandling med ramucirumab (se pkt.
English: Not known (frequency cannot be estimated from the available data): - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
Danish: Ikke kendt (hyppighed kan ikke estimeres ud fra foreliggende data): - En udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner).
English: Patients who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or other Grade 3 or 4 non-haematological toxicities during docetaxel treatment should have treatment withheld until resolution of the toxicity.
Danish: Behandlingen skal afbrydes hos patienter, som får enten febril neutropeni, neutrofiltal <500 celler/mm3 i mere end 1 uge, svære eller kumulative kutane reaktioner eller andre grad 3 eller 4 ikke-hæmatologiske bivirkninger under docetaxelbehandling, indtil toksiciteten er ophørt.
English: Based on ramucirumab's mechanism of action, it is likely that in animals, ramucirumab will inhibit angiogenesis and result in adverse effects on fertility (ovulation), placental development, developing foetuses and postnatal development.
Danish: Ud fra virkningsmekanismen af ramucirumab er det sandsynligt, at ramucirumab hos dyr vil hæmme angiogenese og medføre uønskede effekter på fertilitet (ægløsning), placentaudvikling, voksende fostre og den postnatale udvikling.
English: 3528 BJ Utrecht The Netherlands
Danish: 3528 BJ Utrecht
English: A second reduction of 10 mg/m2 is recommended if these toxicities persist or reoccur.
Danish: Endnu en dosisreduktion med 10 mg/m2 anbefales, hvis disse toksiciteter varer ved eller vender tilbage.
English: - have liver cancer and have had previous bleeding from enlarged veins in your food pipe (oesophagus) or have high blood pressure in the portal vein, which carries the blood from the bowel and spleen to the liver.
Danish: - har leverkræft og tidligere har haft blødning fra forstørrede årer i spiserøret (øsofagus) eller har højt blodtryk i portåren (blodåren, som fører blodet fra tarmen og milten til leveren).
English: Few between-arm differences were reported after the first month of treatment.
Danish: Efter den første behandlingsmåned blev der kun rapporteret få forskelle mellem de 2 arme.
English: No patients had neutralising antibodies to ramucirumab.
Danish: Ingen patienter havde neutraliserende antistoffer over for ramucirumab.
English: No dose modification.
Danish: Ingen dosisjustering.
English: - have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Danish: - Hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
English: No drug-drug interactions were observed between ramucirumab and paclitaxel.
Danish: Der er ikke observeret lægemiddelinteraktioner mellem ramucirumab og paclitaxel.
English: Hepatocellular carcinoma (HCC)
Danish: Hepatocellulært karcinom (HCC)
English: The median duration of docetaxel therapy was 14.1 weeks for the ramucirumab plus docetaxel arm (with a median of 4.0 infusions received) and 12.0 weeks for the placebo plus docetaxel arm (with a median of 4.0 infusions received).
Danish: Den mediane varighed af docetaxelbehandlingen var 14,1 uger for ramucirumab plus docetaxel-armen (med en median på 4,0 modtagne infusioner) og 12,0 uger for placebo plus docetaxel-armen (med en median på 4,0 modtagne infusioner).
English: There are no data on the effect of ramucirumab on human fertility.
Danish: Der foreligger ingen data vedrørende virkningen af ramucirumab på fertiliteten hos mennesker.
English: Symptoms of a heart attack may include chest pain or heaviness in the chest.
Danish: Symptomer på et hjerteanfald kan omfatte brystsmerter eller tyngdefornemmelse i brystkassen.
English: You should avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Cyramza.
Danish: Du skal undgå at blive gravid under behandlingen med dette lægemiddel og i mindst 3 måneder efter sidste dosis af Cyramza.
English: 11% of patients treated with Cyramza and 6% of patients on placebo discontinued therapy due to adverse events.
Danish: 11 % af de patienter, som fik Cyramza, og 6 % af de patienter, som fik placebo, stoppede med behandlingen på grund af bivirkninger.
English: Hazard ratio (95% CI) Stratified log-rank p-value Progression free survival, months Median (95% CI)
Danish: Hazard ratio (95 % KI) Stratificeret log-rank p-værdi Progressionsfri overlevelse, måneder Median (95 % KI)
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.
Danish: I de samlede data fra REACH-2 og REACH (patienter med alfaføtoprotein ≥ 400 ng/ml) blev forekomsten af grad ≥ 3 hypertension øget ved højere ramucirumab-eksponering.
English: Cyramza has no or negligible influence on the ability to drive and use machines.
Danish: Cyramza påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Pulmonary haemorrhage in NSCLC
Danish: Pulmonal blødning ved NSCLC
English: Chemotherapy-related gastrointestinal toxicity
Danish: Kemoterapi-relateret gastrointestinal toksicitet
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.
Danish: Tærsklen for forhøjet AFP for inklusion i REACH-2 blev bestemt ud fra overlevelsesresultaterne fra en præspecificeret subgruppe eksplorativ analyse fra REACH, et tidligere gennemført, støttende klinisk fase 3-studie af 565 HCC-patienter, som var randomiseret (1:1) til enten Cyramza plus BSC eller placebo plus BSC, og som havde sygdomsprogression under eller efter tidligere sorafenibbehandling.
English: Do not administer the solution if you notice any particulate matter or discolouration.
Danish: Opløsningen må ikke indgives, hvis De observerer partikler eller misfarvning.
English: The most common adverse reactions observed in ramucirumab-treated patients are: neutropenia, fatigue/asthenia, leukopenia, epistaxis, diarrhoea and stomatitis.
Danish: De hyppigste bivirkninger, som blev observeret hos patienter behandlet med ramucirumab, er neutropeni, træthed/asteni, leukopeni, epistaxis, diarré og stomatitis.
English: Clinical data suggest that no dose adjustments are required in patients with mild or moderate hepatic impairment.
Danish: Kliniske data tyder på, at dosisjustering ikke er nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: A single dose of ramucirumab did not impair wound healing in monkeys using a full-thickness incisional model.
Danish: En enkelt dosis ramucirumab nedsatte ikke sårhelingsevnen hos aber ved anvendelse af en incisionsmodel i fuld tykkelse.
English: The recommended dose of paclitaxel is 80 mg for every square metre (m²) of your body's surface area once every week for 3 weeks followed by 1 week without treatment.
Danish: Den anbefalede dosis paclitaxel er 80 mg for hver kvadratmeter (m²) legemsoverflade én gang ugentligt i 3 uger efterfulgt af 1 uge uden behandling.
English: Do not dilute with other solutions or co-infuse with other electrolytes or medicinal products.
Danish: MÅ IKKE fortyndes med andre opløsninger eller infunderes samtidig med andre elektrolytter eller lægemidler.
English: DO NOT dilute with other solutions or co-infuse with other electrolytes or medicinal products.
Danish: Må ikke fortyndes med andre opløsninger eller infunderes samtidig med andre elektrolytter eller lægemidler.
English: Cyramza has no or negligible influence on your ability to drive and use machines.
Danish: Cyramza påvirker ikke eller kun i ubetydelig grad din evne til at føre motorkøretøj eller betjene maskiner.
English: - blood clots in the arteries:arterial blood clots can lead to a heart attack or stroke.
Danish: - blodpropper i arterierne: arterielle blodpropper kan medføre hjerteanfald eller slagtilfælde.
English: Talk to your doctor or nurse before you are given Cyramza if you:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sygeplejersken, før du får Cyramza, hvis du:
English: A separate infusion line with a protein sparing 0.22 micron filter must be used for the infusion and the line must be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection at the end of the infusion.
Danish: Der skal anvendes en separat infusionsslange med et proteinbesparende 0,22 mikron filter til infusionen, og slangen skal skylles med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske efter infusionen.
English: A second reduction of 15 mg/m2 is recommended if these toxicities persist or reoccur.
Danish: Endnu en dosisreduktion med 15 mg/m2 anbefales, hvis de toksiske reaktioner varer ved eller vender tilbage.
English: Abbreviations: CI = confidence interval, CR= complete response, PR= partial response, CMH = Cochran-Mantel-Haenszel
Danish: Forkortelser: KI = konfidensinterval, CR= komplet respons, PR= partiel respons, CMH= CochranMantel-Haenszel
English: If you are of East Asian origin, you may receive a reduced docetaxel starting dose of 60 mg per every m2 of your body's surface area once every 3 weeks.
Danish: Hvis du er af østasiatisk oprindelse vil du måske få en reduceret startdosis af docetaxel på 60 mg for hver m2 legemsoverflade én gang hver 3. uge.
English: Route and method of administration
Danish: Indgivelsesvej og anvendelsesmåde
English: REACH-2 was a global, randomised, double-blind study of Cyramza plus BSC versus placebo plus BSC that randomised (2:1) 292 patients with HCC who had a serum AFP ≥ 400 ng/ml at study entry.
Danish: REACH-2 var et globalt, randomiseret, dobbeltblindet studie med Cyramza plus BSC versus placebo plus BSC, der randomiserede (2:1) 292 patienter med HCC, som havde serum AFP ≥ 400ng/ml ved indgangen i studieet.
English: Dose modification at day 1 of cycle subsequent to ADR
Danish: Dosisjustering på dag 1 i den efterfølgende serie efter bivirkningen
English: See prescribing information for paclitaxel, for components of FOLFIRI and for docetaxel, as applicable, for premedication requirements and additional information.
Danish: Se de relevante produktresuméer for henholdsvis paclitaxel, FOLFIRI-komponenterne og docetaxel vedrørende krav til præmedicinering og yderligere information.
English: In severe cases, symptoms may include breathing distress caused by narrowing of the airways, faster heartbeat, and feeling faint.
Danish: I alvorlige tilfælde kan symptomerne omfatte åndedrætsbesvær forårsaget af forsnævrede luftveje og hurtigere hjerteslag samt mathedsfølelse.
English: ADRs of haemangioma and thrombotic microangiopathy were reported in ramucirumab clinical trials at a frequency of common (1.5%) and rare (0.03%), respectively, and through post-marketing reporting.
Danish: Bivirkningerne hæmangiom og trombotisk mikroangiopati blev rapporteret med en hyppighed på henholdsvis almindelig (1,5%) og sjælden (0,03%) i kliniske forsøg med ramucirumab, og ved rapportering efter markedsføring.
English: Overall survival, months Median (95% CI)
Danish: Samlet overlevelse, måneder Median (95 % KI)
English: NSCLC patients with recent pulmonary bleeding (>2.5 ml or bright red blood) as well as patients with evidence of baseline tumour cavitation, regardless of histology, or those with any evidence of tumour invasion or encasement of major blood vessels have been excluded from clinical trials (see section 4.3).
Danish: NSCLC-patienter med nylig pulmonal blødning (> 2,5 ml eller lyst rødt blod) såvel som patienter med evidens for baseline-tumorkavitation, uanset histologi, eller patienter med evidens for, at tumor involverer eller indkapsler større blodkar, blev ekskluderet fra de kliniske studier (se pkt.4.3).
English: Paclitaxel dose reductions may be applied based upon the grade of toxicity experienced by the patient.
Danish: Paclitaxeldosis kan reduceres afhængig af den toksicitetsgrad, som patienten oplever.
English: Excipients: histidine, histidine monohydrochloride, sodium chloride, glycine, polysorbate 80, water for injections.
Danish: Hjælpestoffer: histidin, histidinhydrochlorid, natriumchlorid, glycin, polysorbat 80, vand til injektionsvæsker.
English: The recommended dose of Cyramza for the treatment of lung cancer is 10 mg per kilogram of your body weight once every 3 weeks.
Danish: Den anbefalede dosis af Cyramza til behandling af lungekræft er 10 mg pr. kilogram legemsvægt én gang hver 3. uge.
English: Includes: leukopenia and white blood cell count decreased.
Danish: Dette omfatter: leukopeni og nedsat antal hvide blodlegemer.
English: Inspect the content of the vials for particulate matter and discolouration (the concentrate for solution for infusion should be clear to slightly opalescent and colourless to slightly yellow without visible particles) prior to dilution.
Danish: Kontroller indholdet af hætteglassene for partikler og misfarvning (koncentratet til opløsning til infusion skal være klar til let opaliserende og farveløs til let gul uden synlige partikler) inden fortynding.
English: Calculate the dose and volume of ramucirumab needed to prepare the infusion solution.
Danish: Beregn den dosis og volumen af ramucirumab, som skal bruges til at klargøre infusionsopløsningen.
English: 5-FU infusion 2,400 mg/m2 over 46-48 hours
Danish: 5-FU infusion 2.400 mg/m2 over 46-48 timer
English: There are limited safety data available for patients with severe renal impairment (creatinine clearance 15 to 29 ml/min) treated with ramucirumab (see sections 4.2 and 5.2).
Danish: Der foreligger begrænsede sikkerhedsdata for patienter med svært nedsat nyrefunktion (kreatininclearance 15-29 ml/min), som behandles med ramucirumab (se pkt.
English: Efficacy, as measured by improvements in OS, was associated with increasing ramucirumab exposure range produced by 8 mg/kg ramucirumab given every 2 weeks and by 10 mg/kg ramucirumab given every 3 weeks.
Danish: Effekten, målt som forbedring i OS, var associeret med øget grad af ramucirumabeksponering opnået ved administration af 8 mg/kg ramucirumab givet hver 2. uge og ved 10 mg/kg ramucirumab givet hver 3. uge.
English: Ramucirumab is an antiangiogenic therapy and may increase the risk of severe bleeding.
Danish: Ramucirumab er en antiangiogen behandling, som kan øge risikoen for svær blødning.
English: c Based on study REACH-2 and REACH (single-agent ramucirumab in HCC).
Danish: c Baseret på studierne REACH-2 og REACH (ramucirumab monoterapi ved HCC).
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.
Danish: Patienterne blev randomiseret i forholdet 2:1 til at få en intravenøs infusion af Cyramza 8 mg/kg (n= 238) eller placebo (n= 117) hver anden uge.