FrancophonIA/ELRC3.0 huggingface dataset:
English: Invasive dental procedures should, if possible, be avoided in patients treated with Zaltrap and who have previously received or are receiving intravenous bisphosphonates (see section 4.8).
Danish: Operative tandindgreb skal, hvis muligt, undgås hos patienter i behandling med ZALTRAP, som tidligere har fået eller som får intravenøse bisfosfonater (se pkt.
English: • Wounds which heal slowly or not at all: Uncommon (may affect up to 1 in 100 people) - this is when a scar has trouble healing or staying closed, or if a healed wound re-opens.
Danish: • Sår der heler langsomt eller ikke vil hele: Ikke almindelig (kan påvirke op til 1 ud af 100 personer) - dette er når et ar har vanskeligt ved at hele eller holdes lukket, eller hvis et ophelet sår åbnes igen.
English: Clinical data suggest that no change in starting dose is required in patients with mild to moderate renal impairment.
Danish: Kliniske data tyder på, at der ikke kræves ændring af startdosis til patienter med let til moderat nedsat nyrefunktion.
English: Pre-existing hypertension must be adequately controlled before starting aflibercept.
Danish: Eksisterende hypertension skal være tilstrækkeligt under kontrol, før behandling med aflibercept initieres.
English: The most frequent adverse reactions leading to permanent discontinuation in ≥ 1 % of patients treated with the ZALTRAP/FOLFIRI regimen were vascular disorders (3.8 %) including hypertension (2.3 %), infections (3.4 %), asthenia/fatigue (1.6 %, 2.1 %),diarrhoea (2.3 %), dehydration (1 %), stomatitis (1.1 %), neutropenia (1.1 %), proteinuria (1.5 %), and pulmonary embolism (1.1 %).
Danish: De bivirkninger, som hyppigst medførte permanent seponering hos ≥1 % af patienterne behandlet med ZALTRAP/FOLFIRI-regimet, var vaskulære hændelser (3,8 %) inklusive hypertension (2,3 %), infektioner (3,4 %), asteni/træthed (1,6 %, 2,1 %), diarré (2,3 %), dehydrering (1 %), stomatitis (1,1 %), neutropeni (1,1 %), proteinuri (1,5 %) og lungeemboli (1,1 %).
English: Oxaliplatin-based regimens were administered in combination with bevacizumab in 373 patients (30.4 %).
Danish: Oxaliplatin-baserede regimer blev administreret i kombination med bevacizumab hos 373 patienter
English: EXP Shelf life after dilution: see package leaflet.
Danish: EXP Holdbarhed efter fortynding: Se indlægssedlen.
English: Patients received a median number of 9 cycles of the ZALTRAP/FOLFIRI regimen.
Danish: Patienterne fik i gennemsnit 9 cykler med ZALTRAP/FOLFIRI-regimet.
English: If recurrence, 5-FU bolus and infusion doses should additionally be reduced by 20 % in subsequent cycles.
Danish: Ved recidiv bør 5-FU-bolus og -infusionsdoser desuden reduceres med 20 % i efterfølgende cykler.
English: The diagnosis of PRES is confirmed by brain Magnetic Resonance Imaging (MRI).
Danish: Diagnosen PRES bekræftes med MR-scanning af hjernen.
English: The recommended dose of ZALTRAP, administered as an intravenous infusion over 1 hour, is 4 mg / kg of body weight, followed by the FOLFIRI regimen.
Danish: Den anbefalede dosis ZALTRAP er 4 mg/kg legemsvægt som intravenøs infusion over 1 time efterfulgt af FOLFIRI-regime.
English: Increased AST (2) Increased ALT (2)
Danish: Forhøjet ASAT (2) Forhøjet ALAT (2)
English: • Protein in the urine (also called ‘proteinuria'): Very common (may affect more than 1 in 10 people) - this is very commonly seen in tests.
Danish: • Protein i urinen (også kaldet ‘proteinuri'): Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette er meget almindeligt at se i tests.
English: The most common reported form of bleeding was minor (grade 1-2) epistaxis occurring in 27.7 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Danish: Den hyppigst indberettede form for blødning var mindre (grad 1-2) epistaxis, der forekom hos 27,7 % af patienterne i ZALTRAP-armen.
English: Each vial of concentrate for solution for infusion is for single use (single-dose) only.
Danish: Hvert hætteglas med koncentrat til infusionsvæske er udelukkende til engangsbrug (enkeltdosis).
English: Treatment assignment was stratified by the ECOG performance status (0 versus 1 versus 2) and according to prior therapy with bevacizumab (yes or no).
Danish: Behandlingstildelingen blev stratificeret efter ECOG-performancestatus (0 versus 1 versus 2) og efter tidligere behandling med bevacizumab (ja eller nej).
English: 5.3 (4.50 to 5.55)
Danish: 5,3 (4,50 til 5,55)
English: 5.4 (4.53 to 5.68)
Danish: 5,4 (4,53 til 5,68)
English: For additional toxicities related to irinotecan, 5-FU, or folinic acid, refer to the current respective summary of product characteristics.
Danish: For yderligere toksicitet relateret til irinotecan, 5-FU og folinsyre henvises til de respektive produktresuméer.
English: • you have severe or long-lasting diarrhoea, feel sick (nausea) or are being sick (vomiting) - these could cause severe loss of body fluids (called ‘dehydration').
Danish: • du har alvorlig eller langvarig diarré, føler dig dårlig tilpas (kvalme) eller kaster op - dette kan medføre alvorligt tab af væske (kaldet ‘dehydrering').
English: General disorders and administration site conditions Very common
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig Asteni
English: In the event of a severe hypersensitivity reaction (including bronchospasm, dyspnoea, angioedema, and anaphylaxis), aflibercept should be discontinued and appropriate medical measures should be administered (see section 4.2).
Danish: I tilfælde af en svær overfølsomhedsreaktion (inklusive bronkospasme, dyspnø, angioødem og anafylaksi) bør aflibercept seponeres og passende medicinske foranstaltninger administreres (se pkt.
English: Pack size of 1 vial or 3 vials.
Danish: Pakningsstørrelse på 1 eller 3 hætteglas.
English: Infections occurred at a higher frequency in patients receiving the ZALTRAP/FOLFIRI regimen (46.2 %, all grades; 12.3 %, grade 3-4) than in patients receiving the placebo/FOLFIRI regimen (32.7%, all grades; 6.9 %, grade 3-4), including urinary tract infection, nasopharyngitis, upper respiratory tract infection, pneumonia, catheter site infection, and tooth infection.
Danish: Infektioner forekom med større hyppighed hos patienterne i ZALTRAP-armen (46,2 %, alle grader; 12,3 %, grad 3-4), end hos patienterne i placeboarmen (32,7 %, alle grader; 6,9 %, grad 3-4), inklusive urinvejsinfektion, nasofaryngitis, infektion i de øvre luftveje, pneumoni, infektion af katederanlæggelsesstedet og tandinfektion.
English: Among those patients treated with the ZALTRAP/FOLFIRI regimen developing grade 3-4 hypertension, 54 % had onset during the first two cycles of treatment (see section 4.4).
Danish: Blandt patienterne i ZALTRAP-armen som udviklede grad 3-4-hypertension, fik 54 % symptomer i løbet af de første to cykler af behandlingen (se pkt.
English: ‘Palmar-Plantar Erythrodysaesthesia syndrome')
Danish: ‘palmoplantar erytrodysæstesisyndrom')
English: In case of recurrent medically significant or severe hypertension, despite optimal treatment, aflibercept should be suspended until the hypertension is controlled and the aflibercept dose should be reduced to 2 mg/kg for subsequent cycles.
Danish: I tilfælde af recidiverende signifikant eller svær hypertension, trods optimal behandling, bør aflibercept seponeres, indtil hypertensionen er under kontrol, og aflibercept-dosis reduceres til 2 mg/kg i efterfølgende cykler.
English: Dehydration (1) Decreased appetite Weight loss
Danish: Dehydrering (1) Nedsat appetit Vægttab
English: OS in ITT population excluding patients who progressed during or within 6 months of adjuvant therapy demonstrated an HR (95 % CI) of 0.78 (0.68 to 0.90) [median OS (95 % CI) with Placebo/FOLFIRI 11.9 months (10.88 to 13.01) and with ZALTRAP/FOLFIRI 13.8 months (12.68 to 15.44)]
Danish: Bestemt ved IVRS b Samlet overlevelse i ITT populationen, eksklusive patienter, som progredierede under eller indenfor 6 måneder efter adjuverende behandling, viste en HR (95 % CI) på 0,78 (0,68 til 0,90) [median OS (95 %) for placebo/FOLFIRI 11,9 måneder (10,88 til 13,01) og for ZALTRAP/FOLFIRI 13,8 måneder (12,68 til 15,44)].
English: Among the 1,226 randomised patients, 89.4 % and 90.2 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively, received prior oxaliplatin-based combination chemotherapy in the metastatic/advanced setting.
Danish: Blandt de 1226 randomiserede patienter fik henholdsvis 89,4 % og 90,2 % af de patienter, der behandledes med placebo/FOLFIRI og ZALTRAP/FOLFIRI-regimet, forudgående oxaliplatin-baseret kombinationskemoterapi i det metastaserende/avancerede miljø.
English: In the pivotal MCRC study, anaemia, nausea, vomiting, constipation, alopecia, increased alkaline phosphatase, and hyperbilirubinaemia occurred in ≥ 20 % of patients.
Danish: I det pivotale mCRC-studie forekom anæmi, kvalme, opkastning, obstipation, alopeci, forhøjet basisk fosfatase og hyperbilirubinæmi hos ≥20 % af patienterne.
English: Approximately 10 % of patients (10.4 % and 9.8 % of patients treated with the placebo/FOLFIRI and ZALTRAP/FOLFIRI regimens, respectively) received prior oxaliplatin-based adjuvant chemotherapy and progressed on or within 6 months of completion of adjuvant chemotherapy.
Danish: Cirka 10 % af patienterne (henholdsvis 10,4 % patienter behandlet med placebo/FOLFIRI-regimet og 9,8 % patienter behandlet med ZALTRAP/FOLFIRI-regimet) modtog forudgående oxaliplatin-baseret adjuverende kemoterapi og progredierede ved eller inden for 6 måneder fra gennemførelse af den adjuverende kemoterapi.
English: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Germany
Danish: Sanofi Aventis Deutschland GmbH Industriepark Hoechst 65926 Frankfurt am Main Tyskland
English: In patients receiving ZALTRAP, the adverse reactions in patients with mild renal impairment at baseline in three Phase III placebo-controlled clinical studies (N = 352) were comparable with those of patients without renal impairment (N = 642).
Danish: I tre placebo-kontrollerede kliniske fase III studier (N=352) var bivirkningerne hos ZALTRAPbehandlede patienter med let nedsat nyrefunktion ved baseline (N=352) sammenlignelige med bivirkningerne hos patienter uden nedsat nyrefunktion (N=642).
English: In case of recurrent medically significant or severe hypertension, despite optimal treatment, ZALTRAP should be suspended until the hypertension is controlled and the dose reduced to 2 mg / kg for subsequent cycles.
Danish: I tilfælde af recidiverende signifikant eller svær hypertension, trods optimal behandling, bør ZALTRAP seponeres, indtil hypertensionen er under kontrol, og dosis reduceres til 2 mg/kg i efterfølgende cykler.
English: Monitoring of complete blood count (CBC) with platelets is recommended at baseline, prior to initiation of each cycle of aflibercept, and as clinically necessary.
Danish: Komplet blodtælling (CBC) inklusive trombocytter anbefales ved baseline, før initiering af hver cyklus med aflibercept og efter klinisk behov.
English: ZALTRAP will be given with other chemotherapy medicines including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Danish: ZALTRAP vil blive givet sammen med anden kemoterapi-medicin, herunder ‘5-fluoruracil', ‘folinsyre' og ‘irinotecan'.
English: Febrile neutropenia Thrombocytopenia (2)
Danish: Febril neutropeni Trombocytopeni (2)
English: GI perforation including fatal GI perforation has been reported in patients treated with ZALTRAP.
Danish: GI-perforation inklusive dødelig GI-perforation er blevet indberettet hos patienter, som blev behandlet med ZALTRAP.
English: Table 1 - Adverse reactions reported in patients treated with the ZALTRAP/FOLFIRI regimen from the MCRC study
Danish: Tabel 1 - Bivirkninger rapporteret hos patienter behandlet med ZALTRAP/FOLFIRI-regimet i mCRCstudiet
English: If the bleeding is severe, your doctor will stop your treatment with ZALTRAP.
Danish: Hvis det drejer sig en alvorlig blødning, vil lægen stoppe behandlingen med ZALTRAP.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given ZALTRAP and during your treatment.
Danish: Hvis noget af ovenstående gælder for dig (eller du ikke er sikker), så tal med din læge, apotekspersonalet eller sundhedspersonalet, før du får ZALTRAP og under behandlingen.
English: The patient should remain under close medical supervision to monitor any adverse reactions (see section 4.8).
Danish: Patienten skal holdes under tæt overvågning for at monitorere eventuelle bivirkninger (se pkt.
English: ZALTRAP must not be administered as an intravitreal injection (see section 2 of the package leaflet).
Danish: ZALTRAP må ikke administreres som intravitreal injektion (se punkt 2 i indlægssedlen).
English: 5-FU bolus should be reduced and the infusion dose reduced by 20 %.
Danish: 5-FU-bolus bør reduceres og infusionsdosis reduceres med
English: If you are uncertain contact your doctor.
Danish: Kontakt lægen, hvis du er usikker på noget.
English: Other signs include swelling in one or both legs, pain or tenderness in one or both legs while standing or walking, warmth of the skin on the affected leg, red or discoloured skin in the affected leg or visible veins.
Danish: Andre symptomer omfatter hævelse i det ene eller begge ben, smerter eller ømhed i det ene eller begge ben, når man står eller går, varme i huden på det berørte ben, rød eller misfarvet hud på det berørte ben eller synlige blodårer.
English: Signs of allergic reaction may include rash or itching, skin redness, feeling dizzy or faint, being short of breath, tight chest or throat, or swelling of the face.
Danish: Symptomer på allergiske reaktioner kan omfatte udslæt eller kløe, rødmen af huden, følelse af svimmelhed eller besvimelse, stakåndethed, trykken for brystet, tillukning i halsen eller hævelse af ansigtet.
English: Severe proteinuria, nephrotic syndrome, and thrombotic microangiopathy (TMA) have been observed in patients treated with aflibercept (see section 4.8).
Danish: Svær proteinuri, nefrotisk syndrom og trombotisk mikroangiopati (TMA) er observeret hos patienter behandlet med aflibercept (se pkt.
English: The hazard ratio (95 % CI) of progression free survival was 0.76 (0.63 to 0.91) for ECOG performance status 0 and 0.75 (0.61 to 0.92) for ECOG performance status 1.
Danish: Hazard-ratio for progressionsfri overlevelse var 0,76 (0,63 til 0,91) for ECOG performance status 0 og 0,75 (0,61 til 0,92) for ECOG performance status 1.
English: Proteinuria should be monitored by urine dipstick analysis and/or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria before each aflibercept administration.
Danish: Før hver aflibercept-administration bør proteinuri monitoreres ved urinsticks-analyse og/eller bestemmelse af protein-kreatinin-forholdet i urinen (UPCR) for udvikling eller forværring.
English: Other signs include feeling confused, problems with sight, walking, coordination or balance, problems in saying words or slurring of speech.
Danish: Andre symptomer omfatter en følelse af forvirring, synsproblemer, gangproblemer, koordinationsproblemer eller balanceproblemer, problemer med at udtale ord eller sløret tale.
English: Note: Adverse reactions are reported using MedDRA version MEDDRA13.1 and graded using NCI CTC version 3.0 (1) See “Description of selected adverse reactions” in this section (2) Based on laboratory values (percentages done on patients with laboratory assessments) (3) Compilation of clinical and laboratory data
Danish: Bemærk: Bivirkninger er rapporteret ved hjælp af MedDRA version MEDDRA13.1 og gradueret ved hjælp af NCI CTC version 3.0 (1) Se "Beskrivelse af udvalgte bivirkninger" i dette afsnit (2) Baseret på laboratorieværdier (procentdele udledt på patienter med laboratorievurderinger) (3) Sammensat af kliniske data og laboratoriedata (4) Ikke rapporteret i mCRC-studiet; imidlertid blev PRES rapporteret hos patienter behandlet med aflibercept som monoterapi og i kombination med kemoterapi, som ikke var FOLFIRI, i andre studier.
English: • High blood pressure (also called ‘hypertension'): Very common (may affect more than 1 in 10 people) - this may develop or get worse.
Danish: • Forhøjet blodtryk (også kaldet ‘hypertension'): Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette kan udvikles eller forværres.
English: In other studies, PRES was reported in patients treated with aflibercept as monotherapy and in combination with other chemotherapies (see section 4.8).
Danish: I andre studier blev PRES rapporteret hos patienter behandlet med aflibercept som monoterapi og i kombination med anden kemoterapi (se pkt.
English: Most aflibercept-induced effects were reversible after a 5-month drug free period with the exception of skeletal and nasal cavity findings.
Danish: De fleste aflibercept-inducerede påvirkninger var reversible efter en 5-måneders medicinfri periode med undtagelse af fund i skelet og næsehule De fleste fund ansås at være relateret til aflibercepts farmakologiske aktivitet.
English: Common (may affect up to 1 in 10 people)
Danish: Almindeligt (kan påvirke op til 1 ud af 10 personer)
English: Clinical data suggest that no change in aflibercept dose is required in patients with mild to moderate hepatic impairment.
Danish: Kliniske data tyder på, at der ikke kræves ændring af aflibercept-dosis til patienter med let til moderat nedsat leverfunktion.
English: In patients with RAS wild type tumours the HR (95 % CI) for OS was 0.7 (0.5-1.0) with a median OS of 16.0 months for patients treated with aflibercept, and 11.7 months for the patients treated with placebo.
Danish: Hos patienter med RASvildtypetumor var HR (95 % CI) for samlet overlevelse (OS) 0,7 (0,5-1,0) med en median OS på 16,0 måneder for patienter, som fik aflibercept, og 11,7 måneder for patienter i placebogruppen.
English: In sexually mature female cynomolgus monkeys inhibition of ovarian function and follicular development was evidenced.
Danish: Hos seksuelt modne huncynomolgusaber er der påvist tegn på hæmning af ovariefunktion og follikeludvikling.
English: • Holes in the gut (also called ‘gastro-intestinal perforation'): Uncommon (may affect up to 1 in 100 people) - this is a hole in the stomach, food pipe, gut or bowel.
Danish: • Huller i tarmen (også kaldet ‘gastrointestinal perforation'): Ikke almindeligt (kan påvirke op til 1 ud af 100 personer) - dette er et hul i mavesækken, spiserøret eller tarmene.
English: Stratified log-rank test p-value
Danish: Stratificeret Log-Rank test p-værdi Progressionsfri overlevelse (PFS)
English: After dilution in the infusion bag
Danish: Efter fortynding i infusionsposen
English: ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) have been observed in patients treated with aflibercept (see section 4.8).
Danish: Der er observeret ATE (inklusive transitorisk iskæmisk attak, cerebrovaskulær hændelse, angina pectoris, intrakardiel trombe, myokardieinfarkt, arteriel emboli og iskæmisk colitis) hos patienter behandlet med aflibercept (se pkt.
English: • difficulty when breathing
Danish: • åndedrætsbesvær
English: Preparation of the infusion solution
Danish: Klargøring af infusionsopløsningen
English: 200 mg / 8 ml 1 vial
Danish: 200 mg/8 ml 1 hætteglas
English: 11.7 (9.66 to 13.27) 13.8 (11.01 to 15.87)
Danish: 11,7 (9,66 til 13,27) 13,8 (11,01 til 15,87)
English: Also contains sucrose, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium hydroxide and/or hydrochloric acid and water for injections.
Danish: Indeholder også saccharose, natriumchlorid, natriumcitratdihydrat, citronsyremonohydrat, polysorbat 20, dinatriumphosphatheptahydrat, natriumdihydrogenphosphatmonohydrat, natriumhydroxid og/eller saltsyre samt vand til injektionsvæsker.
English: Grade 3 hypertension (requiring adjustment in existing anti-hypertensive therapy or treatment with more than one medicinal product) was reported in 1.5 % of patients treated with the placebo/FOLFIRI regimen and 19.1 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Danish: Grad 3 hypertension (der krævede justering af eksisterende antihypertensiv behandling eller behandling med mere end et lægemiddel) blev indberettet hos 1,5 % af patienterne i placeboarmen og hos 19,1 % i ZALTRAP-armen.
English: 0.817 (0.714 to 0.935)
Danish: 0,817 (0,714 til 0,935)
English: Signs of infection may include fever, chills, cough, burning on passing water or muscle ache.
Danish: Symptomer på infektion kan omfatte feber, kulderystelser, hoste, brændende fornemmelse, når du lader vandet, eller muskelsmerter.
English: If recurrence, the treatment should be suspended until <2 grams per 24 hours and then the dose reduces to 2 mg/kg.
Danish: Ved recidiv bør behandlingen seponeres indtil <2 gram/24 timer, og derefter reduceres dosis til 2 mg/kg.
English: A higher incidence of neutropenic complications (febrile neutropenia and neutropenic infection) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Danish: Der er observeret en højere forekomst af neutropeniske komplikationer (febril neutropeni og neutropenisk infektion) hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt.
English: Reproductive and developmental toxicology
Danish: Reproduktions- og udviklingstoksikologi
English: Sodium citrate dihydrate
Danish: Natriumcitratdihydrat
English: Compromised wound healing Aflibercept impaired wound healing in animal models (see section 5.3).
Danish: Kompromitteret sårheling Aflibercept hæmmede sårhelingen i dyrestudier (se pkt.
English: Signs may include chest pain or heaviness in the chest, sudden numb or weak feeling in the face, arms, or legs.
Danish: Symptomerne kan omfatte smerter i brystet eller tung fornemmelse i brystet, pludselig følelsesløshed eller svaghedsfølelse i ansigt, arme eller ben.
English: Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased.
Danish: Seponer ZALTRAP hos patienter, der oplever hjerteinsufficiens og nedsat ejektionsfraktion.
English: • Low white blood cell count (also called ‘neutropenia'): Very common (may affect more than 1 in 10 people) - this can cause serious infections.
Danish: • Lavt antal hvide blodlegemer (også kaldet ‘neutropeni'): Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette kan medføre alvorlige infektioner.
English: In other studies, severe intracranial haemorrhage and pulmonary haemorrhage/haemoptysis including fatal events have occurred in patients receiving ZALTRAP (see section 4.4).
Danish: I andre studier er der forekommet svær intrakraniel blødning og pulmonal blødning/hæmoptyse inklusive dødelige hændelser hos patienter, der fik ZALTRAP (se pkt.
English: The concentrate is a clear, colourless to pale yellow solution.
Danish: Koncentratet er en klar, farveløs til lysegul opløsning.
English: Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections
Danish: Dinatriumphosphatheptahydrat Natriumdihydrogenphosphatmonohydrat Natriumhydroxid og/eller saltsyre (til justering af pH) Vand til injektionsvæsker
English: 12.06 (11.07 to 13.08) 13.50 (12.52 to 14.95)
Danish: 12,06 (11,07 til 13,08) 13,50 (12,52 til 14,95)
English: The FOLFIRI regimen to be used is irinotecan 180 mg/m intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400 mg / m² intravenous bolus, followed by 5-FU 2400 mg / m² continuous intravenous infusion over 46 hours.
Danish: 90 minutter og folinsyre (dl racemisk) 400 mg/m² som intravenøs infusion over 2 timer på samme tidspunkt på dag 1 via en Y-linje, efterfulgt af 5-fluoruracil (5-FU) 400 mg/m² som intravenøs bolus, efterfulgt af 5-FU 2.400 mg/m² som kontinuerlig intravenøs infusion over 46 timer.
English: 6.7 (5.75 to 8.21)
Danish: 6.7 (5,75 til 8,21)