FrancophonIA/ELRC3.0 huggingface dataset:
English: A consistent improvement (ramucirumab plus docetaxel vs placebo plus docetaxel) was observed in important subgroups for PFS and OS. OS subgroup results included the following: non-squamous histology (HR 0.83; 95% CI: 0.71 to 0.97; median OS [mOS]: 11.1 vs 9.7 months) and squamous histology (HR 0.88; 95% CI: 0.69 to 1.13; mOS: 9.5 vs 8.2 months); patients with prior maintenance (HR 0.69; 95% CI: 0.51 to 0.93; mOS: 14.4 vs 10.4 months); time since start of prior therapy <9 months (HR 0.75; 95% CI: 0.64 to 0.88; mOS: 9.3 vs 7.0 months); patients <65 years old (HR 0.74, 95% CI: 0.62, 0.87; mOS: 11.3 vs 8.9 months).
Danish: Subgrupperesultater for OS inkluderede følgende: ikke-planocellulær histologi (HR 0,83; 95 % KI: 0;71-0,97; median OS [mOS]: 11,1 vs 9,7 måneder) og planocellulær histologi (HR 0,88; 95 % KI: 0,69-1,13; mOS: 9,5 vs 8,2 måneder); patienter med tidligere vedligeholdelsesbehandling (HR 0,69; 95 % KI: 0,51-0,93; mOS: 14,4 vs 10,4 måneder); tid siden start af tidligere behandling < 9 måneder (HR 0,75; 95 % KI: 0,64-0,88; mOS: 9,3 vs 7,0 måneder; patienter < 65 år (HR 0,74, 95 % KI: 0,62-0,87; mOS: 11,3 vs 8,9 måneder).
English: Patients were required to have experienced disease progression during, or within 4 months after the last dose of first-line therapy and with ECOG PS 0-1.
Danish: Patienterne skulle have oplevet sygdomsprogression under førstelinjebehandling eller inden for 4 måneder efter sidste dosis af førstelinjebehandlingen og have en ECOG PS på 0-1.
English: Branchburg New Jersey NJ 08876
Danish: ImClone Systems LLC 33 ImClone Drive, Branchburg New Jersey NJ 08876
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
Danish: Almindelige bivirkninger (kan ramme op til 1 ud af 10 personer): - feber ledsaget af et lavt antal hvide blodlegemer - lave niveauer i blodet af det protein, der hedder albumin - infusionrelaterede reaktioner - udslæt - rødme, hævelse, følelsesløshed/prikkende følelse, eller smerte og/eller afskalning af huden på hænder og fødder (hånd-fod-syndrom) - lavt natriumindhold i blodet (hyponatriæmi), som kan medføre træthed og forvirring eller muskeltrækninger - forvirring og/eller desorientering hos patienter med kroniske leverproblemer - blokering af tarmen; symptomerne kan omfatte forstoppelse og mavesmerter - unormal vækst af blodkar - alvorlig infektion (blodforgiftning) - lavt kaliumindhold i blodet (hypokaliæmi), som kan medføre muskelsvaghed, muskeltrækninger eller unormal hjerterytme
English: The HR of OS was 0.82 (95% CI: 0.67 to 1.0) in patients with a KRAS wild type tumour, and 0.89 (95% CI: 0.73 to 1.09) in patients with a KRAS mutant tumour.
Danish: HR for OS var 0,82 (95 % KI: 0,67-1,0) hos patienter med KRAS wild type tumor, og 0,89 (95 % KI: 0,73-1,09) hos patienter med KRAS-muterende tumor.
English: Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level.
Danish: Når urinproteinniveauet er faldet til <2 g/24timer, bør behandlingen genoptages med en lavere dosis.
English: gemcitabine (25%), taxane (24%), and bevacizumab (14%); 22% of patients received prior maintenance therapy.
Danish: De hyppigste tidligere behandlinger inkluderede pemetrexed (38 %), gemcitabin (25 %), taxan (24 %) og bevacizumab (14 %), 22 % af patienterne havde tidligere fået vedligeholdelsesbehandling.
English: If a patient experiences a second Grade 1 or 2 infusion-related reaction (IRR) administer dexamethasone (or equivalent); then, for subsequent infusions, premedicate with the following or equivalent medicinal products: an intravenous histamine H1 antagonist (for example diphenhydramine hydrochloride), paracetamol and dexamethasone.
Danish: Derefter skal der ved efterfølgende infusioner gives præmedicinering med følgende eller tilsvarende lægemidler: En intravenøs histamin H1-antagonist (f.eks. diphenhydraminhydrochlorid), paracetamol og dexamethason.
English: Objective response rate [ORR(complete response [CR] + partial response [PR])] was significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (Odds ratio 2.140; 95% CI: 1.499 to 3.160; p=0.0001).
Danish: Objektiv responsrate [ORR (komplet respons [CR] + partiel respons [PR])] var signifikant bedre hos de patienter, som fik Cyramza plus paclitaxel sammenlignet med dem, som fik placebo plus paclitaxel (oddsratio 2,140; 95 % KI: 1,499 til 3,160; p=0,0001).
English: Pack of 1 vial of 50 ml.
Danish: Pakning med 1 hætteglas med 50 ml.
English: Ramucirumab therapy must be initiated and supervised by physicians experienced in oncology.
Danish: Behandling med ramucirumab må kun initieres og administreres under tilsyn af en onkolog.
English: Pack of 2 vials of 10 ml.
Danish: Pakning med 2 hætteglas med 10 ml.
English: The concentrate for solution for infusion (or sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow solution in a glass vial with a rubber stopper.
Danish: Koncentratet til infusionsvæske, opløsning (eller sterilkoncentratet) er en klar til let opaliserende og farveløs til let gul opløsning i et hætteglas med gummiprop.
English: Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.
Danish: Cyramza i kombination med docetaxel er indiceret til behandling af voksne patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer med sygdomsprogression efter platinbaseret kemoterapi.
English: A second dose reduction (see Table 3) is recommended if a urine protein level ≥2 g/24 hours reoccurs.
Danish: Yderligere dosisreduktion (se tabel 3) anbefales, hvis urinproteinniveau ≥ 2 g/24 timer vender tilbage.
English: 10 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
Danish: 10 ml-opløsning i et hætteglas (type I-glas) med en gummiprop af klorbutyl, en aluminiumsforsegling og en polypropylenhætte.
English: Includes: anal haemorrhage, diarrhoea haemorrhage, gastric haemorrhage, gastrointestinal haemorrhage, haematemesis, haematochezia, haemorrhoidal haemorrhage, Mallory-Weiss syndrome, melaena, oesophageal haemorrhage, rectal haemorrhage, and upper gastrointestinal haemorrhage.
Danish: Dette omfatter: anal blødning, blodig diarré, gastrisk blødning, gastrointestinal blødning, hæmatemese, hæmatokeksi, hæmorideblødning, Mallory-Weiss-syndrom, melæna, øsofageal blødning, rektal blødning og øvre gastrointestinal blødning.
English: 2,000 mg/m2 over 46-48 hours
Danish: 2.000 mg/m2 over 46-48 timer
English: Patients with a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders, a recent history of severe (Grade ≥3) bleeding or who had experienced an arterial thrombotic event (ATE) in the 12 months
Danish: Patienter med tidligere ukontrolleret arvelig eller erhvervet blødnings- eller trombotiske sygdomme, nyligt tilfælde af svær (grad ≥3) blødning, eller som havde haft en arteriel tromboembolisk hændelse (ATE) indenfor 12 måneder før randomisering, blev ekskluderet.
English: 50 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
Danish: 50 ml-opløsning i et hætteglas (type I-glas) med en gummiprop af klorbutyl, en aluminiumsforsegling og en polypropylenhætte.
English: b Includes: hypokalaemia and blood potassium decreased.
Danish: b Dette omfatter: hypokaliæmi og fald i kaliumniveauet i blodet.
English: FOLFIRI chemotherapy is given by intravenous infusion, after the Cyramza infusion has finished.
Danish: Når du får Cyramza i kombination med FOLFIRI FOLFIRI-kemoterapi gives som intravenøs infusion, efter Cyramza-infusionen er færdig.
English: Ramucirumab should be permanently discontinued in the event of hepatic encephalopathy or hepatorenal syndrome (see section 4.2).
Danish: Ramucirumab skal seponeres permanent i tilfælde af hepatisk encefalopati eller hepatorenalt syndrom (se pkt.
English: (12.5%), thrombocytopenia (4.2%), diarrhoea (2.3%) and stomatitis (2.3%).
Danish: De hyppigste bivirkninger (≥1 %), der medførte seponering af en eller flere af FOLFIRI-komponenterne, var neutropeni (12,5 %), trombocytopeni (4,2 %), diarré (2,3 %) og stomatitis (2,3 %).
English: Time and dose dependency
Danish: Tids- og dosisafhængighed
English: Tél: +33-(0) 1 55 49 34 34
Danish: Lilly France SAS Tél: +33-(0) 1 55 49 34 34
English: Fatiguea,i Mucosal inflammationd Peripheral oedema a Terms represent a group of events that describe a medical concept rather than a single event or preferred term.
Danish: Perifert ødem a Termen repræsenterer en gruppe bivirkninger, som beskriver et medicinsk begreb frem for en enkelt bivirkning eller en foretrukken term.
English: Cyramza will be permanently stopped if you experience severe bleeding.
Danish: Behandlingen med Cyramza vil blive stoppet permanent, hvis du oplever alvorlige blødning.
English: Aseptically transfer the calculated volume of ramucirumab to the intravenous container.
Danish: Under aseptiske forhold overføres den beregnede mængde ramucirumab til den intravenøse beholder.
English: EU/1/14/957/001-003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/957/001-003
English: There have been no formal studies with Cyramza in patients with renal impairment.
Danish: Der er ikke udført formelle studier med Cyramza til patienter med nedsat nyrefunktion.
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)
Danish: Behandlingen med Cyramza vil blive stoppet permanent, hvis du: - udvikler en blodprop i en arterie - udvikler et hul i tarmvæggen - får alvorlig blødning - får en alvorlig infusionsrelateret reaktion - udvikler forhøjet blodtryk, som ikke kan kontrolleres med medicin - udskiller mere end en vis mængde protein i urinen, eller hvis De udvikler en alvorlig nyresygdom (nefrotisk syndrom) - udvikler unormale rørlignende forbindelser eller passager inde i kroppen mellem indre organer og huden eller andet væv (fistler) - udvikler forvirring og/eller bliver desorienteret i forbindelse med kroniske leverproblemer - nedsat nyrefunktion (i forbindelse med leversvigt)
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.
Danish: Cyramza er indiceret som monoterapi til behandling af voksne patienter med fremskreden eller inoperabelt hepatocellulært karcinom, med serum alfaføtoprotein (AFP) ≥ 400 ng/ml og som tidligere er blevet behandlet med sorafenib.
English: Symptoms may include: increased muscle tension, back pain, chest pain and/or tightness, chills, flushing, difficulty in breathing, wheezing, and feeling of tingling or numbness in hands or feet.
Danish: Symptomerne kan være: øget muskelspænding, rygsmerter, brystsmerter og/eller strammende fornemmelse i brystregionen, kulderystelser, rødme, vejrtrækningsbesvær, hvæsende vejrtrækning samt prikken og stikken eller følelsesløshed i hænder eller fødder.
English: The recommended dose of ramucirumab is 8 mg/kg on days 1 and 15 of a 28 day cycle, prior to paclitaxel infusion.
Danish: Den anbefalede dosis af ramucirumab er 8 mg/kg på dag 1 og 15 i en 28-dages-serie inden infusion af paclitaxel.
English: The metabolism of ramucirumab has not been studied.
Danish: Biotransformation Metabolismen for ramucirumab er ikke undersøgt.
English: Table 9: Summary of efficacy data - ITT population
Danish: Tabel 9: Resumé af effektdata - ITT-population
English: Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget for krav om brailleskrift
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Ikke almindelig (≥ 1/1.000 til <1/100)
English: REVEL, a randomised, double-blind study of Cyramza plus docetaxel versus placebo plus docetaxel, was conducted in 1253 patients with locally advanced or metastatic squamous or non-squamous NSCLC with disease progression on or after one platinum-based therapy.
Danish: REVEL, et randomiseret, dobbeltblindt studie med Cyramza plus docetaxel versus placebo plus docetaxel, blev udført med 1.253 patienter med lokalt fremskreden eller metastatisk planocellulær eller ikke-planocellulær NSCLC med sygdomsprogression under eller efter en platinbaseret behandling.
English: Table 8: Summary of efficacy data - Intent to treat (ITT) population Cyramza plus paclitaxel N=330
Danish: Tabel 8: Resumé af effektdata - Intent to treat (ITT)-population Cyramza plus paclitaxel N=330
English: 4.4), patients pre-treated with taxanes (HR 0.81; 95% CI:0.62 to 1.07; mOS 10.8 vs 10.4 months) and those with time since start of prior therapy ≥9 months (HR 0.95; 95% CI: 0.75 to 1.2; mOS: 13.7 vs
Danish: 4.4), af patienter tidligere behandlet med taxan (HR 0,81; 95 % KI: 0,62-1,07; mOS 10,8 vs 10,4 måneder) og for dem, hvor tiden siden påbegyndelse af tidligere behandling var ≥9 måneder (HR 0,95; 95 % KI: 0,75-1,2; mOS: 13,7 vs 13,3 måneder).
English: The recommended dose of ramucirumab is 8 mg/kg every 2 weeks administered by intravenous infusion, prior to FOLFIRI administration.
Danish: Den anbefalede ramucirumabdosis er 8 mg/kg hver anden uge som intravenøs infusion før administration af FOLFIRI.
English: Ramucirumab should be temporarily discontinued for severe hypertension until controlled with medical management.
Danish: Ramucirumab skal seponeres midlertidigt ved svær hypertension, indtil denne er bragt under kontrol med medicinsk behandling.
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.
Danish: RAISE var et globalt, randomiseret, dobbeltblindt studie med Cyramza plus FOLFIRI versus placebo plus FOLFIRI til patienter med mCRC, som havde sygdomsprogression under eller efter førstelinjebehandling med bevacizumab, oxaliplatin og et fluorpyrimidin.
English: 1,600 mg/m2 over 46-48 hours
Danish: 1.600 mg/m2 over 46-48 timer
English: In a study conducted in animals, ramucirumab did not impair wound healing.
Danish: I et dyreforsøg nedsatte ramucirumab ikke sårhelingsevnen.
English: Symptoms included rigors/tremors, back-pain/spasms, chest pain and/or tightness, chills, flushing, dyspnoea, wheezing, hypoxia, and paraesthesia.
Danish: Symptomerne omfattede rystelser, rygsmerter/kramper, brystsmerter og/eller strammende fornemmelse i brystet, kulderystelser, rødme, dyspnø, hvæsen, hypoxi og paræstesi.
English: A trend towards less efficacy with increasing age has been observed in patients receiving ramucirumab plus docetaxel for the treatment of advanced NSCLC with disease progression after platinum-based chemotherapy (see section 5.1).
Danish: Der er observeret en tendens til mindre effekt jo højere alder hos patienter, som fik ramucirumab plus docetaxel til behandling af fremskreden NSCLC med sygdomsprogression efter platinbaseret kemoterapi (se pkt 5.1).
English: The most frequent component of FOLFIRI to be discontinued was the 5-FU bolus.
Danish: 5-FU bolus var den FOLFIRI-komponent, der hyppigst blev seponeret.
English: Spontaneous development of fistula (see section 4.4).
Danish: Spontan opståen af fistler (se pkt.
English: Gastric cancer and gastro-oesophageal junction (GEJ) adenocarcinoma
Danish: Gastrisk cancer og adenokarcinom i den gastroøsofagale overgang (GEJ)
English: What you need to know before you are given Cyramza You must not be given Cyramza
Danish: Det skal du vide, før du begynder at bruge Cyramza Sådan får du Cyramza
English: Each 50 ml vial contains approximately 85 mg sodium.
Danish: Hvert 50 ml hætteglas indeholder cirka 85 mg natrium.
English: Cyramza is a cancer medicine that contains the active substance ramucirumab, which is a monoclonal antibody.
Danish: Det indeholder det aktive stof ramucirumab, som er et monoklonalt antistof.
English: Only use sodium chloride 9 mg/ml (0.9%) solution for injection as a diluent.
Danish: Brug kun 9 mg/ml (0,9 %) natriumchloridinjektionsvæske som fortyndingsmiddel.
English: The recommended dose of ramucirumab is 10 mg/kg on day 1 of a 21 day cycle, prior to docetaxel infusion.
Danish: Den anbefalede ramucirumabdosis er 10 mg/kg på dag 1 i en 21-dages-serie før infusion af docetaxel.
English: Hepatocellular carcinoma
Danish: Hepatocellulært karcinom
English: Haematological criteria in Table 2 are not met
Danish: Hæmatologiske kriterier i tabel 2 er ikke opnået
English: Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
Danish: Cyramza i kombination med FOLFIRI (irinotecan, folinsyre og fluoruracil) er indiceret til behandling af voksne patienter med metastatisk kolorektal cancer (mCRC) med sygdomsprogression under eller efter tidligere behandling med bevacizumab, oxaliplatin og et fluorpyrimidin.
English: Clinical data suggest that no dose adjustments are required in patients with mild, moderate or severe renal impairment (see sections 4.4 and 5.2).
Danish: Kliniske data tyder på, at dosisjustering ikke er nødvendig hos patienter med let, moderat eller svært nedsat nyrefunktion (se pkt.
English: Exposure-response analyses indicated that efficacy was correlated with ramucirumab exposure across pivotal studies.
Danish: I alle pivotale studier indikerede eksponerings-respons-analyser, at effekten var korreleret til eksponeringen for ramucirumab.
English: Very common side effects (may affect more than 1 in 10 people): - low white blood cell counts (may increase the risk of infection) - feeling tired or weak - diarrhoea - nose bleed - inflammation of the lining of the mouth - swelling of hands, feet and legs due to fluid retention - high blood pressure - low platelet count (blood cells that help the blood to clot) - abdominal pain - inflammation of mucous membranes, such as digestive and respiratory tracts - headache - protein in the urine (abnormal urine test)
Danish: Meget almindelige bivirkninger (kan ramme mere end 1 ud af 10 personer): - lavt antal hvide blodlegemer (kan øge risikoen for infektion) - trætheds- eller svaghedsfornemmelse - diarré - næseblod - betændelse i mundens slimhinde - hævede hænder, fødder og ben på grund af væskeophobning - forhøjet blodtryk - lavt antal blodplader (blodceller, som hjælper blodet med at størkne) - mavesmerter - betændelse i slimhinderne, såsom i fordøjelseskanalen og luftvejene.
English: Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome.
Danish: Behandling med ramucirumab skal seponeres permanent, hvis urinproteinniveauet er > 3 g/24 timer eller i tilfælde af nefrotisk syndrom.
English: Hepatic encephalopathy or hepatorenal syndrome (see section 4.4).
Danish: Hepatisk encefalopati eller hepatorenalt syndrom (se pkt.
English: Cyramza is used 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 and for whom treatment of Cyramza in combination with paclitaxel is not suitable.
Danish: Cyramza bruges 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, og hvor behandling med Cyramza sammen med paclitaxel ikke er hensigtsmæssigt.
English: If Grade 4 diarrhoea does not resolve to Grade ≤1, withhold 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1.
Danish: Hvis grad 4 diarré ikke bedres til grad ≤1, seponeres 5-FU og irinotecan i højst 28* dage indtil restitution til grad ≤1.
English: General disorders and administration site disorders
Danish: Almene symptomer og reaktioner på administrationsstedet
English: If stomatitis/mucositis has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Danish: Hvis stomatitis/mucositis er bedret til grad ≤1, reduceres med 1 dosisniveau for 5-FU.
English: An increased incidence of stomatitis was reported in patients receiving ramucirumab in combination with chemotherapy as compared to patients treated with placebo plus chemotherapy.
Danish: En øget forekomst af stomatitis blev indberettet for patienter, der fik ramucirumab i kombination med kemoterapi, sammenlignet med patienter, som fik placebo plus kemoterapi.
English: A hospital pharmacist, nurse or doctor will have diluted the contents of the vial with sodium chloride 9 mg/ml
Danish: Sygehusapotekets farmaceut, sygeplejerske eller læge har fortyndet indholdet i hætteglasset med natriumchloridinfusionsvæske 9 mg/ml (0,9 %) inden brug.
English: Ramucirumab therapy should be permanently discontinued in the event of: Severe arterial thromboembolic events (see section 4.4).
Danish: Behandling med ramucirumab skal seponeres permanent i tilfælde af: Svære arterielle tromboemboliske hændelser (se pkt.
English: Haematological criteria in Table 2 are not met and fever resolved
Danish: De hæmatologiske kriterier i tabel 2 er ikke opnået, og feber er ophørt
English: Table 10: Summary of efficacy data - ITT population Cyramza plus FOLFIRI N=536
Danish: Tabel 10: Resumé af effektdata - ITT-population Cyramza plus FOLFIRI N=536
English: Ramucirumab therapy should be temporarily discontinued if the urine protein level is ≥2 g/24 hours.
Danish: Behandlingen med ramucirumab skal seponeres midlertidigt, hvis urinproteinniveauet er ≥ 2 g/24 timer.
English: Treatment with Cyramza may need to be stopped temporarily until the levels of protein in the urine decrease and then treatment resumed at a lower dose, or stopped permanently if the urine protein level does not reduce sufficiently.
Danish: Derefter kan behandlingen genoptages ved en lavere dosis eller stoppes permanenet, hvis mængden af protein i urinen ikke nedsættes tilstrækkeligt.
English: A second dose reduction is recommended if a urine protein level ≥2 g/24 hours reoccurs.
Danish: En yderligere dosisreduktion er anbefalet, såfremt urinproteinniveauer på ≥2 g/24 timer vender tilbage.
English: Ramucirumab should be permanently discontinued in patients who experience gastrointestinal perforations (see section 4.2).
Danish: Ramucirumab skal seponeres permanent hos patienter, som oplever gastrointestinale perforationer (se pkt.
English: The recommended dose of docetaxel is 75 mg/m2 administered by intravenous infusion over approximately 60 minutes on day 1 of a 21 day cycle.
Danish: Den anbefalede docetaxeldosis er 75 mg/m2 som intravenøs infusion over cirka 60 minutter på dag 1 i en 21-dages-serie.