FrancophonIA/ELRC3.0 huggingface dataset:
English: • polyvinyl chloride (PVC) containing bis(2-ethylhexyl) phthalate (DEHP)
Danish: Infusionssættene skal være fremstillet af et af følgende materialer: • polyvinylchlorid (PVC) indeholdende bis(2-ethylhexyl)phthalat (DEHP)
English: Do not use ZALTRAP: • if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section
Danish: • hvis du er allergisk over for aflibercept eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Respiratory, thoracic and mediastinal disorders Very common
Danish: Aneurismer og arterielle dissektioner Luftveje, thorax og mediastinum Meget almindelig Dyspnø Epistaxis
English: 0.812 (0.634 to 1.042)
Danish: 0,812 (0,634 til 1,042)
English: An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section
Danish: Der er observeret en øget risiko for grad 3-4 hypertension (inklusive hypertension og et tilfælde af essentiel hypertension) hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt.
English: In sub-group analysis of overall survival, a benefit consistent with the overall population was observed in patients < 65 years old and ≥ 65 years old who received the ZALTRAP/FOLFIRI regimen.
Danish: I subgruppeanalyse af samlet overlevelse hos patienter <65 år og ≥65 år der fik ZALTRAP/FOLFIRIregimet, observeredes en fordel svarende til den for den samlede population.
English: Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles.
Danish: Præmedicinering med kortikosteroider og/eller antihistaminer kan overvejes i de efterfølgende cykler.
English: Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP.
Danish: Hjerteinsufficiens og nedsat ejektionsfraktion er blevet rapporteret hos patienter behandlet med ZALTRAP.
English: 0.645 (0.498 to 0.835)
Danish: 0,645 (0,498 til 0,835)
English: The most common reported grades 3-4 reactions ( ≥5 % incidence) reported at least 2 % greater incidence for the ZALTRAP/FOLFIRI regimen as compared to the placebo/FOLFIRI regimen in order of decreasing frequency, were neutropenia, diarrhoea, hypertension, leucopenia, stomatitis, fatigue, proteinuria, and asthenia (see Table 1).
Danish: De hyppigst rapporterede grad 3-4 reaktioner (≥5 % forekomst) med mindst 2 % højere forekomst for ZALTRAP/FOLFIRI-regimet end for placebo/FOLFIRI-regimet var, med faldende frekvens: neutropeni, diarré, hypertension, leukopeni, stomatitis, træthed, proteinuri og asteni (se Tabel 1).
English: Signs may include feeling very tired, weak, and/or dizzy, or having changes in the colour of your stool.
Danish: Symptomer på blødning kan være træthed, svaghed og/eller svimmelhed eller ændringer i farven på din afføring.
English: Tel.: 0800 04 36 996 Tel. aus dem Ausland: +49 69 305 70 13
Danish: Tel. aus dem Ausland: +49 69 305 70 13
English: • Blocking of the veins by a blood clot (also called ‘venous thrombo-embolic events'): Common (may affect up to 1 in 10 people) - this may include a blood clot in the lungs or legs.
Danish: • Blokering af blodårerne på grund af en blodprop (også kaldet ‘venøse tromboemboliske hændelser'): Almindeligt (kan påvirke op til 1 ud af 10 personer) - dette kan omfatte en blodprop i lungerne eller benene.
English: There are no data regarding the administration of aflibercept in patients with severe hepatic impairment.
Danish: Der foreligger ingen data vedrørende administration af aflilbercept til patienter med svært nedsat leverfunktion.
English: A total of 1,226 patients were randomised (1:1) to receive either ZALTRAP (N = 612; 4 mg/kg as a 1 hour intravenous infusion on day 1) or placebo (N = 614), in combination with 5-fluouracil plus irinotecan [FOLFIRI: 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-FU 400 mg/m² intravenous bolus, followed by 5-FU 2,400 mg /m² continuous intravenous infusion over 46-hours].
Danish: Ialt 1226 patienter blev randomiseret (1:1) til at få enten ZALTRAP (N=612; 4 mg/kg som 1 times intravenøs infusion på dag 1) eller placebo (N=614), i kombination med 5-fluouracil plus irinotecan [FOLFIRI: irinotecan 180 mg/m2 intravenøs infusion over 90 minutter og folinsyre (dl racemisk) 400 mg/m²
English: 6.90 (6.51 to 7.20)
Danish: 6,90 (6,51 til 7,20)
English: This population included; 549 patients with mild renal impairment (CL CR between 50-80 ml/min), 96 patients with moderate renal impairment (CL CR between 30-50 ml/min), and 5 patients with severe renal impairment (CL CR < 30 ml/min).
Danish: Denne population omfattede: 549 patienter med let nedsat nyrefunktion (CLCR mellem 50-80 ml/min.
English: ZALTRAP is a medicine used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults.
Danish: ZALTRAP er et lægemiddel der bruges til at behandle fremskreden kræft i tyktarmen og endetarmen hos voksne.
English: One ml of concentrate contains 25 mg aflibercept.
Danish: En ml koncentrat indeholder 25 mg aflibercept.
English: • Cardiac failure and ejection fraction decreased
Danish: • Hjerteinsufficiens og nedsat ejektionsfraktion
English: • drop in the number of certain cells in the blood that help it to clot (thrombocytopenia)
Danish: • fald i antallet af visse celler i blodet (blodplader), der hjælper det med at koagulere
English: One vial of 4 ml contains 100 mg of aflibercept (25 mg / ml).
Danish: Et 4 ml hætteglas indeholder 100 mg aflibercept (25 mg/ml).
English: • Heart failure (also called cardiac failure); Uncommon (may affect up to 1 in 100 people) - Signs may include shortness of breath when you lie down or when you exert yourself, excessive tiredness or leg swelling.
Danish: • Hjertesvigt (også kaldet hjerteinsufficiens): Ikke almindeligt (kan påvirke op til 1 ud af 100 personer) - symptomerne kan omfatte åndenød når du ligger ned, eller når du anstrenger dig, overdreven træthed eller hævede ben.
English: • The other ingredients are: 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: - Øvrige indholdsstoffer: Saccharose, natriumchlorid, natriumcitratdihydrat, citronsyremonohydrat, polysorbat 20, natriumdihydrogenphosphatmonohydrat, dinatriumphosphatheptahydrat, natriumhydroxid og/eller saltsyre samt vand til injektionsvæsker.
English: Nephrotic syndrome (1) Thrombotic microangiopathy (1)
Danish: Nefrotisk syndrom (1) Trombotisk mikroangiopati (1)
English: Venous thromboembolic events (VTE)
Danish: Venøs tromboemboli (VTE)
English: 0.661 (0.512 to 0.852)
Danish: 0,661 (0,512 til 0,852)
English: 0.862 (0.676 to 1.100)
Danish: 0,862 (0,676 til 1,100)
English: What ZALTRAP looks like and contents of the pack ZALTRAP is a concentrate for solution for infusion (sterile concentrate).
Danish: Udseende og pakningstørrelser ZALTRAP er et koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: • Arterial thromboembolic events (ATE)
Danish: • Arteriel tromboemboli (ATE)
English: Metabolism and nutrition disorders Very common
Danish: Metabolisme og ernæring Meget almindelig Nedsat appetit Vægttab
English: Patients should be monitored for signs and symptoms of cardiac failure and ejection fraction decreased.
Danish: Patienter bør monitoreres for tegn og symptomer på hjerteinsufficiens og nedsat ejektionsfraktion.
English: ZALTRAP should be suspended when proteinuria ≥2 grams per 24 hours and resumed when proteinuria < 2 grams per 24 hours.
Danish: ZALTRAP bør seponeres ved proteinuri ≥2 gram per 24 timer og genoptages ved proteinuri <2 gram per 24 timer.
English: GI perforation (1) Rectal haemorrhage Fistula (1) Aphthous stomatitis Proctalgia
Danish: GI-perforation (1) Rektal blødning Fistel (1) Aftøs stomatitis Proktalgi
English: An increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events has been reported in patients treated with aflibercept (see section 4.8).
Danish: Der er rapporteret om en øget risiko for blødninger, inklusive svær og til tider dødelig blødning, hos patienter behandlet med aflibercept (se pkt.
English: Signs may include stomach pain, being sick (vomiting), fever or chills.
Danish: Symptomerne kan omfatte mavesmerter, kvalme (opkastning), feber eller kulderystelser.
English: In the pivotal study of MCRC patients, positive responses in the ADA assay were observed at higher levels in patients treated with the placebo/FOLFIRI regimen [18/526 (3.4 %)] than with the ZALTRAP/FOLFIRI regimen [8/521 (1.5 %)].
Danish: I det pivotale studie med mCRC-patienter blev der i højere grad observeret positiv respons i ADA-analysen hos patienter i placeboarmen [18/526 (3,4 %)] end i ZALTRAP-armen [8/521 (1,5 %)].
English: Fistula formation involving GI and non-GI sites has occurred in patients treated with aflibercept (see section 4.8).
Danish: Fisteldannelse omfattende GI og ikke-GI-lokaliteter er forekommet hos patienter behandlet med aflibercept (se pkt.
English: Palmar-Plantar Erythrodysaesthesia syndrome
Danish: Palmoplantar erytrodysæstesisyndrom
English: Aflibercept should be discontinued in patients with compromised wound healing requiring medical intervention (see section 4.2).
Danish: Aflibercept bør seponeres hos patienter med kompromitteret sårheling, som kræver intervention (se pkt.
English: 11.7 (9.96 to 13.77) 12.5 (10.78 to 15.47)
Danish: 11,7 (9,96 til 13,77) 12,5 (10,78 til 15,47)
English: Aflibercept treatment should be discontinued in patients who develop nephrotic syndrome or TMA (see section 4.2).
Danish: Aflibercept bør seponeres hos patienter, der udvikler nefrotisk syndrom eller TMA (se pkt.
English: 0.797 (0.679 to 0.936)
Danish: 0,797 (0,679 til 0,936)
English: Treatment with corticosteroids and/or antihistamines can be initiated as clinically indicated.
Danish: Behandling med kortikosteroider og/eller antihistaminer kan initieres, hvis det er klinisk indiceret.
English: ZALTRAP 25 mg / ml sterile concentrate aflibercept
Danish: ZALTRAP 25 mg/ml sterilt koncentrat aflibercept
English: Treatment with corticosteroids and/or antihistamines can be used as clinically indicated.
Danish: Behandling med kortikosteroider og/eller antihistaminer kan benyttes, hvis det er klinisk indiceret.
English: 6.7 (5.72 to 8.21)
Danish: 6,7 (5,72 til 8,21)
English: Median OS (95 % CI) (months)
Danish: Median OS (95 % CI) (måneder)
English: Positive results in the neutralising antibody assay in the MCRC pivotal study were also higher in patients treated with the placebo/FOLFIRI regimen [2/526 (0.38 % )] than with the ZALTRAP/FOLFIRI regimen [1/521 (0.19 %)].
Danish: I det pivotale mCRC-studie var positive resultater i analysen af neutraliserende antistoffer også hyppigere hos patienterne i placeboarmen [2/526 (0,38 %)] end i ZALTRAP-armen [1/521 (0,19 %)].
English: VTE including deep vein thrombosis (DVT) and pulmonary embolism (infrequently fatal) have been reported in patients treated with aflibercept (see section 4.8).
Danish: Der er rapporteret om VTE inklusive dyb venetrombose (DVT) og lungeemboli (sjældent dødelig) hos patienter behandlet med aflibercept (se pkt.
English: Thrombocytopenia has been reported in patients treated with the ZALTRAP/FOLFIRI regimen.
Danish: Der er rapporteret om trombocytopeni hos patienter behandlet med ZALTRAP/FOLFIRI-regimet.
English: An increased risk of grade 3-4 hypertension (including hypertension and one case of essential hypertension) has been observed in patients receiving the ZALTRAP/FOLFIRI regimen.
Danish: Der er observeret en øget risiko for grad 3-4 hypertension (inklusive hypertension og et tilfælde af essentiel hypertension) hos patienter i ZALTRAP-armen.
English: One vial of 8 ml contains 200 mg of aflibercept (25 mg / ml).
Danish: Et 8 ml hætteglas indeholder 200 mg aflibercept (25 mg/ml).
English: Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles (see section 4.2).
Danish: Præmedicinering med kortikosteroider og/eller antihistaminer kan overvejes i de efterfølgende cykler (se pkt.
English: The hazard ratio (95 % CI) of overall survival was 0.77 (0.64 to 0.93) for ECOG performance status 0 and 0.87 (0.71 to 1.06) for ECOG
Danish: Analyse for OS og PFS blev også udført ved ECOG PS. Hazard-ratio (95 % CI) for samlet overlevelse var 0,77 (0,64 til 0,93) for ECOG performance status 0 og 0,87 (0,71 til 1,06) for ECOG performance status 1.
English: Median PFS (95 % CI) (months)
Danish: Median PFS (95 % CI) (måneder)
English: 0.777 (0.655 to 0.921)
Danish: 0,777 (0,655 til 0,921)
English: In other studies, PRES was reported in patients treated with monotherapy ZALTRAP (0.5 %) and in combination with other chemotherapies (see section 4.4).
Danish: I andre studier blev PRES rapporteret hos patienter behandlet med ZALTRAP (0,5 %) som monoterapi og i kombination med anden kemoterapi (se pkt.
English: ZALTRAP Treatment delay and dose modification
Danish: Udsættelse af behandling og dosisjustering
English: Potential for compromised wound healing (wound dehiscence, anastomotic leakage) has been reported with aflibercept (see section 4.8).
Danish: Der er rapporteret om mulighed for kompromiteret sårheling (sårruptur, anastomotisk lækage) med aflibercept (se pkt.
English: • Blocking of the arteries by a blood clot (also called ‘arterial thrombo-embolic events'): Common (may affect up to 1 in 10 people) - this may lead to a stroke or heart attack.
Danish: • Blokering af pulsårerne på grund af en blodprop (også kaldet ‘arterielle tromboemboliske hændelser'): Almindeligt (kan påvirke op til 1 ud af 10 personer) - dette kan medføre slagtilfælde eller hjerteanfald.
English: Mild to moderate hypersensitivity reactions to ZALTRAP (including flushing, rash, urticaria, and pruritus) (see section 4.4)
Danish: Lette til moderate overfølsomhedsreaktioner på ZALTRAP (inklusive ansigtsrødme, udslæt, urticaria og pruritus) (se pkt.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie 75008 Paris
Danish: Indehaver af markedsføringstilladelsen sanofi-aventis groupe 54, rue La Boétie
English: STATEMENT OF ACTIVE SUBSTANCE(S )
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: Signs may include chest pain, coughing, being short of breath, difficulty breathing or coughing up blood.
Danish: Symptomerne kan omfatte smerter i brystet, hoste, stakåndethed, vejrtrækningsbesvær eller ophostning af blod.
English: Aflibercept should not be administered to patients with severe haemorrhage (see section 4.2).
Danish: Aflibercept bør ikke administreres til patienter med svær blødning (se pkt.
English: Arterial thromboembolic events (ATE)
Danish: Arteriel tromboemboli (ATE)
English: In the pivotal study of MCRC patients, ATE (including transient ischaemic attack, cerebrovascular accident, angina pectoris, intracardiac thrombus, myocardial infarction, arterial embolism, and ischaemic colitis) were reported in 2.6 % of patients treated with the ZALTRAP/FOLFIRI regimen and 1.5 % of patients treated with the placebo/FOLFIRI regimen.
Danish: I det pivotale studie med mCRC-patienter blev ATE (inklusive transitorisk iskæmisk attak, cerebrovaskulær hændelse, angina pectoris, intrakardiel trombe, myokardieinfarkt, arteriel emboli og iskæmisk colitis) indberettet hos 2,6 % af patienterne i ZALTRAP-armen og hos 1,5 % i placeboarmen.
English: Hypersensitivity (1)
Danish: Overfølsomhed (1)
English: Proteinuria (see section 4.4)
Danish: Proteinuri (se pkt.
English: OS and PFS by stratification factors were performed.
Danish: Der blev udført analyser for samlet overlevelse (OS) og progressionsfri overlevelse (PFS) ved stratifikationsfaktorer.
English: Administration of the infusion solution
Danish: Administration af infusionsvæsken
English: Arterial thromboembolic events
Danish: Arteriel tromboemboli
English: 12.4 (11.17 to 13.54) 13.9 (12.72 to 15.64)
Danish: 12,4 (11,17 til 13,54) 13,9 (12,72 til 15,64)
English: 0.766 (0.645 to 0.908)
Danish: 0,766 (0,645 til 0,908)
English: This may include medicines obtained without a prescription or herbal medicines.
Danish: Dette gælder også for medicin som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: Other signs may include swelling in one or both legs, pain or tenderness in one or both legs, discolouration and warmth of the skin on 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, misfarvning og varme i huden på det berørte ben eller synlige blodårer.
English: ZALTRAP must not be administered as an intravitreal injection (see section 4.3).
Danish: ZALTRAP må ikke administreres som intravitreal injektion (se pkt.
English: Skin and subcutaneous tissue disorders Very common
Danish: Hud og subkutane væv
English: In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Danish: I pivotalstudiet med mCRC-patienter er der rapporteret om svære overfølsomhedsreaktioner hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt.
English: Infections and infestations Very common
Danish: Infektioner og parasitære sygdomme Meget almindelig Infektion (1)
English: Number of events, n (%) Median PFS (95 % CI) (months)
Danish: Antal hændelser, n (%) Gennemsnit PFS (95 % CI) (måneder)
English: 0.788 (0.671 to 0.925)
Danish: 0,788 (0,671 til 0,925)
English: Grade 4 hypertension (hypertensive crisis) was reported in 1 patient (0.2 %) treated with the ZALTRAP/FOLFIRI regimen.
Danish: Grad 4 hypertension (hypertensiv krise) blev indberettet hos 1 patient (0,2 %) i ZALTRAP-armen.
English: Median overall survival (95 % CI) (months)
Danish: Median samlet overlevelse (95 % CI) (måneder)
English: A higher incidence of severe diarrhoea has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Danish: Der er observeret en højere forekomst af svær diarré hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt.
English: 6.9 (6.37 to 7.20)
Danish: 6,9 (6,37 til 7,20)
English: There have been no formal studies with ZALTRAP in patients with renal impairment.
Danish: Der er ikke gennemført formelle studier med ZALTRAP hos patienter med nedsat nyrefunktion.
English: 6.9 (6.24 to 7.20)
Danish: 6,9 (6,24 til 7,20)
English: Male and female fertility are likely to be compromised during treatment with aflibercept based on studies in monkeys (see section 5.3).
Danish: Baseret på studier hos aber er det sandsynligt, at mænds og kvinders fertilitet påvirkes af behandling med aflibercept (se pkt.
English: 0.758 (0.661 to 0.869)
Danish: 0,758 (0,661 til 0,869)
English: ZALTRAP/FOLFIRI Treatment delay or dose modification Neutropenia or thrombocytopenia (see sections 4.4 and 4.8)
Danish: Udsættelse af behandling eller dosisjustering Neutropeni eller trombocytopeni (se pkt.
English: Number of death events, n (%) Median overall survival (95 % CI) (months)
Danish: Samlet overlevelse Antal dødsfald, n (%) Gennemsnit samlet overlevelse (95 % CI) (måneder)
English: Aflibercept should be discontinued in patients that develop PRES (see section 4.2).
Danish: Aflibercept bør seponeres hos patienter, der udvikler PRES (se pkt.
English: • The active substance is aflibercept.
Danish: ZALTRAP indeholder - Aktivt stof: aflibercept.
English: GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8).
Danish: GI-perforation, inklusive dødelig GI-perforation, er blevet rapporteret hos patienter behandlet med aflibercept (se pkt.
English: The most common grade 3-4 neutropenic complication was the occurrence of febrile neutropenia in 4.3 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 1.7 % of patients treated with the placebo/FOLFIRI regimen.
Danish: Den hyppigste grad 3-4 neutropeniske komplikation var forekomst af febril neutropeni hos 4,3 % af patienterne i ZALTRAParmen og hos 1,7 % i placeboarmen.
English: Dose modification of FOLFIRI regimen (see section 4.2), anti-diarrhoeal medicinal products, and rehydration as needed should be instituted.
Danish: 4.2), antidiarrépræparater og rehydrering bør institueres efter behov.
English: Patients with no prior bevacizumab excluding adjuvant only (n ( %))
Danish: Patienter med forudgående bevacizumab behandling eksklusive patienter med kun adjuverende (n (%))
English: Rectal haemorrhage Fistula (1) Aphthous stomatitis Haemorrhoids Proctalgia Toothache
Danish: Rektal blødning Fistel (1) Aftøs stomatitis Hæmorroider Proktalgi Tandpine
English: Patients with no prior bevacizumab (n (%)) Median OS (95 % CI) (months)
Danish: Patienter uden forudgående bevacizumab (n (%)) Median OS (95 % CI) (måneder)
English: In the pivotal study of MCRC patients, proteinuria (compiled from clinical and laboratory data) was reported in 62.2 % patients treated with the ZALTRAP/FOLFIRI regimen compared to 40.7 % patients treated with the placebo/FOLFIRI regimen.
Danish: I det pivotale studie med mCRC-patienter blev der indberettet proteinuri (sammensat af kliniske data og laboratoriedata) hos 62,2 % af patienterne i ZALTRAP-armen og hos 40,7 % i placeboarmen.
English: 100 mg / 4 ml 1 vial
Danish: 100 mg/4 ml 1 hætteglas 3 hætteglas
English: Leucopenia (2) Neutropenia (1),(2) Thrombocytopenia (2)
Danish: Blod og lymfesystem Meget almindelig Leukopeni (2) Neutropeni (1),(2) Trombocytopeni (2)
English: In the pivotal study of MCRC patients, hypertension (all grades) has been reported in 41.2 % of patients treated with ZALTRAP/FOLFIRI and 10.7 % of patients treated with placebo/FOLFIRI.
Danish: I det pivotale studie med mCRC-patienter er der rapporteret om hypertension (alle grader) hos 41,2 % af patienterne i ZALTRAP-armen og hos 10,7 % i placeboarmen.
English: / L (see section 4.2).
Danish: 9/l (se pkt.
English: Compromised wound healing (1)
Danish: Kompromitteret sårheling (1)
English: Aflibercept treatment should be discontinued in patients who experience an ATE (see section 4.2).
Danish: Aflibercept bør seponeres hos patienter, der oplever en ATE (se pkt.
English: One ml of concentrate for solution for infusion contains 25 mg aflibercept*.
Danish: En ml koncentrat til infusionsvæske, opløsning indeholder 25 mg aflibercept*.
English: Dehydration (all grades) has been observed in 9.0 % of patients treated with ZALTRAP/FOLFIRI and 3.0 % of patients treated with placebo/FOLFIRI.
Danish: Dehydrering (alle grader) er observeret hos 9,0 % af patienterne i ZALTRAP-armen og hos 3,0 % i placeboarmen.
English: • Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Danish: • Svære overfølsomhedsreaktioner (inklusive bronkospasme, dyspnø, angioødem og anafylaksi)
English: Patients with no prior bevacizumab (n (%)) Median PFS (95 % CI) (months)
Danish: Patienter uden forudgående bevacizumab (n (%)) Median PFS (95 % CI) (måneder)
English: Cardiac failure and ejection fraction decreased
Danish: Hjerteinsufficiens og nedsat ejektionsfraktion
English: In the pivotal study of MCRC patients, diarrhoea (all grades) has been observed in 69.2 % of patients treated with ZALTRAP/FOLFIRI and 56.5 % of patients treated with placebo/FOLFIRI.
Danish: I det pivotale studie med mCRC-patienter er der observeret diarré (alle grader) hos 69,2 % af patienterne i ZALTRAP-armen og hos 56,5 % i placeboarmen.
English: Compromised wound healing
Danish: Kompromitteret sårheling
English: • runny nose
Danish: • rindende næse
English: Performance status and co-morbidities
Danish: Performancestatus og komorbiditet
English: Impairment of fertility
Danish: Fertilitetshæming
English: Oropharyngeal pain Rhinorrhoea
Danish: Orofanryngeale smerter Rinorré
English: Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1)
Danish: Arteriel tromboemboli (1) Venøs tromboemboli (1) Blødning (1)
English: Patients with prior bevacizumab (n (%))
Danish: Patienter med forudgående bevacizumab (n (%))