natgillin/translations-raw huggingface dataset:
Kliniske data tyder på, at der ikke kræves ændring af aflibercept-dosis til patienter med let til moderat nedsat leverfunktion. 
Clinical data suggest that no change in aflibercept dose is required in patients with mild to moderate hepatic impairment.
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. 
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.
Hos seksuelt modne huncynomolgusaber er der påvist tegn på hæmning af ovariefunktion og follikeludvikling. 
In sexually mature female cynomolgus monkeys inhibition of ovarian function and follicular development was evidenced.
• 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. 
• 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.
Stratificeret Log-Rank test p-værdi Progressionsfri overlevelse (PFS) 
Stratified log-rank test p-value
Efter fortynding i infusionsposen 
After dilution in the infusion bag
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. 
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).
• åndedrætsbesvær 
• difficulty when breathing
Klargøring af infusionsopløsningen 
Preparation of the infusion solution
200 mg/8 ml 1 hætteglas 
200 mg / 8 ml 1 vial
11,7 (9,66 til 13,27) 13,8 (11,01 til 15,87) 
11.7 (9.66 to 13.27) 13.8 (11.01 to 15.87)
Indeholder også saccharose, natriumchlorid, natriumcitratdihydrat, citronsyremonohydrat, polysorbat 20, dinatriumphosphatheptahydrat, natriumdihydrogenphosphatmonohydrat, natriumhydroxid og/eller saltsyre samt vand til injektionsvæsker. 
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.
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. 
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.
0,817 (0,714 til 0,935) 
0.817 (0.714 to 0.935)
Symptomer på infektion kan omfatte feber, kulderystelser, hoste, brændende fornemmelse, når du lader vandet, eller muskelsmerter. 
Signs of infection may include fever, chills, cough, burning on passing water or muscle ache.
Ved recidiv bør behandlingen seponeres indtil <2 gram/24 timer, og derefter reduceres dosis til 2 mg/kg. 
If recurrence, the treatment should be suspended until <2 grams per 24 hours and then the dose reduces to 2 mg/kg.
Der er observeret en højere forekomst af neutropeniske komplikationer (febril neutropeni og neutropenisk infektion) hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt. 
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).
Reproduktions- og udviklingstoksikologi 
Reproductive and developmental toxicology
Natriumcitratdihydrat 
Sodium citrate dihydrate
Kompromitteret sårheling Aflibercept hæmmede sårhelingen i dyrestudier (se pkt. 
Compromised wound healing Aflibercept impaired wound healing in animal models (see section 5.3).
Symptomerne kan omfatte smerter i brystet eller tung fornemmelse i brystet, pludselig følelsesløshed eller svaghedsfølelse i ansigt, arme eller ben. 
Signs may include chest pain or heaviness in the chest, sudden numb or weak feeling in the face, arms, or legs.
Seponer ZALTRAP hos patienter, der oplever hjerteinsufficiens og nedsat ejektionsfraktion. 
Discontinue ZALTRAP in patients who experience cardiac failure and ejection fraction decreased.
• Lavt antal hvide blodlegemer (også kaldet ‘neutropeni'): Meget almindeligt (kan påvirke mere end 1 ud af 10 personer) - dette kan medføre alvorlige infektioner. 
• Low white blood cell count (also called ‘neutropenia'): Very common (may affect more than 1 in 10 people) - this can cause serious infections.
I andre studier er der forekommet svær intrakraniel blødning og pulmonal blødning/hæmoptyse inklusive dødelige hændelser hos patienter, der fik ZALTRAP (se pkt. 
In other studies, severe intracranial haemorrhage and pulmonary haemorrhage/haemoptysis including fatal events have occurred in patients receiving ZALTRAP (see section 4.4).
Koncentratet er en klar, farveløs til lysegul opløsning. 
The concentrate is a clear, colourless to pale yellow solution.
Dinatriumphosphatheptahydrat Natriumdihydrogenphosphatmonohydrat Natriumhydroxid og/eller saltsyre (til justering af pH) Vand til injektionsvæsker 
Sodium phosphate dibasic heptahydrate Sodium phosphate monobasic monohydrate Sodium hydroxide and/or hydrochloric acid (for pH adjustment) Water for injections
12,06 (11,07 til 13,08) 13,50 (12,52 til 14,95) 
12.06 (11.07 to 13.08) 13.50 (12.52 to 14.95)
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. 
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.
6.7 (5,75 til 8,21) 
6.7 (5.75 to 8.21)
Infusionssættene skal være fremstillet af et af følgende materialer: • polyvinylchlorid (PVC) indeholdende bis(2-ethylhexyl)phthalat (DEHP) 
• polyvinyl chloride (PVC) containing bis(2-ethylhexyl) phthalate (DEHP)
• hvis du er allergisk over for aflibercept eller et af de øvrige indholdsstoffer (angivet i punkt 6). 
Do not use ZALTRAP: • if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section
Aneurismer og arterielle dissektioner Luftveje, thorax og mediastinum Meget almindelig Dyspnø Epistaxis 
Respiratory, thoracic and mediastinal disorders Very common
0,812 (0,634 til 1,042) 
0.812 (0.634 to 1.042)
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. 
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
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. 
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.
Præmedicinering med kortikosteroider og/eller antihistaminer kan overvejes i de efterfølgende cykler. 
Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles.
Hjerteinsufficiens og nedsat ejektionsfraktion er blevet rapporteret hos patienter behandlet med ZALTRAP. 
Cardiac failure and ejection fraction decreased have been reported in patients treated with ZALTRAP.
0,645 (0,498 til 0,835) 
0.645 (0.498 to 0.835)
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). 
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).
Symptomer på blødning kan være træthed, svaghed og/eller svimmelhed eller ændringer i farven på din afføring. 
Signs may include feeling very tired, weak, and/or dizzy, or having changes in the colour of your stool.
• 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. 
• 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.
Der foreligger ingen data vedrørende administration af aflilbercept til patienter med svært nedsat leverfunktion. 
There are no data regarding the administration of aflibercept in patients with severe hepatic impairment.
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 
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].
6,90 (6,51 til 7,20) 
6.90 (6.51 to 7.20)
Denne population omfattede: 549 patienter med let nedsat nyrefunktion (CLCR mellem 50-80 ml/min. 
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).
ZALTRAP er et lægemiddel der bruges til at behandle fremskreden kræft i tyktarmen og endetarmen hos voksne. 
ZALTRAP is a medicine used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults.
En ml koncentrat indeholder 25 mg aflibercept. 
One ml of concentrate contains 25 mg aflibercept.
• Hjerteinsufficiens og nedsat ejektionsfraktion 
• Cardiac failure and ejection fraction decreased
• fald i antallet af visse celler i blodet (blodplader), der hjælper det med at koagulere 
• drop in the number of certain cells in the blood that help it to clot (thrombocytopenia)
Et 4 ml hætteglas indeholder 100 mg aflibercept (25 mg/ml). 
One vial of 4 ml contains 100 mg of aflibercept (25 mg / ml).
• 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. 
• 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.
- Øvrige indholdsstoffer: Saccharose, natriumchlorid, natriumcitratdihydrat, citronsyremonohydrat, polysorbat 20, natriumdihydrogenphosphatmonohydrat, dinatriumphosphatheptahydrat, natriumhydroxid og/eller saltsyre samt vand til injektionsvæsker. 
• 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.
Nefrotisk syndrom (1) Trombotisk mikroangiopati (1) 
Nephrotic syndrome (1) Thrombotic microangiopathy (1)
Venøs tromboemboli (VTE) 
Venous thromboembolic events (VTE)
0,661 (0,512 til 0,852) 
0.661 (0.512 to 0.852)
0,862 (0,676 til 1,100) 
0.862 (0.676 to 1.100)
Udseende og pakningstørrelser ZALTRAP er et koncentrat til infusionsvæske, opløsning (sterilt koncentrat). 
What ZALTRAP looks like and contents of the pack ZALTRAP is a concentrate for solution for infusion (sterile concentrate).
• Arteriel tromboemboli (ATE) 
• Arterial thromboembolic events (ATE)
Metabolisme og ernæring Meget almindelig Nedsat appetit Vægttab 
Metabolism and nutrition disorders Very common
Patienter bør monitoreres for tegn og symptomer på hjerteinsufficiens og nedsat ejektionsfraktion. 
Patients should be monitored for signs and symptoms of cardiac failure and ejection fraction decreased.
ZALTRAP bør seponeres ved proteinuri ≥2 gram per 24 timer og genoptages ved proteinuri <2 gram per 24 timer. 
ZALTRAP should be suspended when proteinuria ≥2 grams per 24 hours and resumed when proteinuria < 2 grams per 24 hours.
GI-perforation (1) Rektal blødning Fistel (1) Aftøs stomatitis Proktalgi 
GI perforation (1) Rectal haemorrhage Fistula (1) Aphthous stomatitis Proctalgia
Der er rapporteret om en øget risiko for blødninger, inklusive svær og til tider dødelig blødning, hos patienter behandlet med aflibercept (se pkt. 
An increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events has been reported in patients treated with aflibercept (see section 4.8).
Symptomerne kan omfatte mavesmerter, kvalme (opkastning), feber eller kulderystelser. 
Signs may include stomach pain, being sick (vomiting), fever or chills.
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 %)]. 
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 %)].
Fisteldannelse omfattende GI og ikke-GI-lokaliteter er forekommet hos patienter behandlet med aflibercept (se pkt. 
Fistula formation involving GI and non-GI sites has occurred in patients treated with aflibercept (see section 4.8).
Palmoplantar erytrodysæstesisyndrom 
Palmar-Plantar Erythrodysaesthesia syndrome
Aflibercept bør seponeres hos patienter med kompromitteret sårheling, som kræver intervention (se pkt. 
Aflibercept should be discontinued in patients with compromised wound healing requiring medical intervention (see section 4.2).
11,7 (9,96 til 13,77) 12,5 (10,78 til 15,47) 
11.7 (9.96 to 13.77) 12.5 (10.78 to 15.47)
Aflibercept bør seponeres hos patienter, der udvikler nefrotisk syndrom eller TMA (se pkt. 
Aflibercept treatment should be discontinued in patients who develop nephrotic syndrome or TMA (see section 4.2).
0,797 (0,679 til 0,936) 
0.797 (0.679 to 0.936)
Behandling med kortikosteroider og/eller antihistaminer kan initieres, hvis det er klinisk indiceret. 
Treatment with corticosteroids and/or antihistamines can be initiated as clinically indicated.
ZALTRAP 25 mg/ml sterilt koncentrat aflibercept 
ZALTRAP 25 mg / ml sterile concentrate aflibercept
Behandling med kortikosteroider og/eller antihistaminer kan benyttes, hvis det er klinisk indiceret. 
Treatment with corticosteroids and/or antihistamines can be used as clinically indicated.
6,7 (5,72 til 8,21) 
6.7 (5.72 to 8.21)
Median OS (95 % CI) (måneder) 
Median OS (95 % CI) (months)
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 %)]. 
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 %)].
Der er rapporteret om VTE inklusive dyb venetrombose (DVT) og lungeemboli (sjældent dødelig) hos patienter behandlet med aflibercept (se pkt. 
VTE including deep vein thrombosis (DVT) and pulmonary embolism (infrequently fatal) have been reported in patients treated with aflibercept (see section 4.8).
Der er rapporteret om trombocytopeni hos patienter behandlet med ZALTRAP/FOLFIRI-regimet. 
Thrombocytopenia has been reported in patients treated with the ZALTRAP/FOLFIRI regimen.
Der er observeret en øget risiko for grad 3-4 hypertension (inklusive hypertension og et tilfælde af essentiel hypertension) hos patienter i ZALTRAP-armen. 
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.
Et 8 ml hætteglas indeholder 200 mg aflibercept (25 mg/ml). 
One vial of 8 ml contains 200 mg of aflibercept (25 mg / ml).
Præmedicinering med kortikosteroider og/eller antihistaminer kan overvejes i de efterfølgende cykler (se pkt. 
Pre-treatment with corticosteroids and/or antihistamines may be considered in subsequent cycles (see section 4.2).
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. 
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
Median PFS (95 % CI) (måneder) 
Median PFS (95 % CI) (months)
0,777 (0,655 til 0,921) 
0.777 (0.655 to 0.921)
I andre studier blev PRES rapporteret hos patienter behandlet med ZALTRAP (0,5 %) som monoterapi og i kombination med anden kemoterapi (se pkt. 
In other studies, PRES was reported in patients treated with monotherapy ZALTRAP (0.5 %) and in combination with other chemotherapies (see section 4.4).
Udsættelse af behandling og dosisjustering 
ZALTRAP Treatment delay and dose modification
Der er rapporteret om mulighed for kompromiteret sårheling (sårruptur, anastomotisk lækage) med aflibercept (se pkt. 
Potential for compromised wound healing (wound dehiscence, anastomotic leakage) has been reported with aflibercept (see section 4.8).
• 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. 
• 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.
Lette til moderate overfølsomhedsreaktioner på ZALTRAP (inklusive ansigtsrødme, udslæt, urticaria og pruritus) (se pkt. 
Mild to moderate hypersensitivity reactions to ZALTRAP (including flushing, rash, urticaria, and pruritus) (see section 4.4)
Indehaver af markedsføringstilladelsen sanofi-aventis groupe 54, rue La Boétie 
Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie 75008 Paris
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 
STATEMENT OF ACTIVE SUBSTANCE(S )
Symptomerne kan omfatte smerter i brystet, hoste, stakåndethed, vejrtrækningsbesvær eller ophostning af blod. 
Signs may include chest pain, coughing, being short of breath, difficulty breathing or coughing up blood.
Aflibercept bør ikke administreres til patienter med svær blødning (se pkt. 
Aflibercept should not be administered to patients with severe haemorrhage (see section 4.2).
Arteriel tromboemboli (ATE) 
Arterial thromboembolic events (ATE)
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. 
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.
Overfølsomhed (1) 
Hypersensitivity (1)
Proteinuri (se pkt. 
Proteinuria (see section 4.4)
Der blev udført analyser for samlet overlevelse (OS) og progressionsfri overlevelse (PFS) ved stratifikationsfaktorer. 
OS and PFS by stratification factors were performed.
Administration af infusionsvæsken 
Administration of the infusion solution
Arteriel tromboemboli 
Arterial thromboembolic events
12,4 (11,17 til 13,54) 13,9 (12,72 til 15,64) 
12.4 (11.17 to 13.54) 13.9 (12.72 to 15.64)
0,766 (0,645 til 0,908) 
0.766 (0.645 to 0.908)
Dette gælder også for medicin som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler. 
This may include medicines obtained without a prescription or herbal medicines.
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. 
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.
ZALTRAP må ikke administreres som intravitreal injektion (se pkt. 
ZALTRAP must not be administered as an intravitreal injection (see section 4.3).
Hud og subkutane væv 
Skin and subcutaneous tissue disorders Very common
I pivotalstudiet med mCRC-patienter er der rapporteret om svære overfølsomhedsreaktioner hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt. 
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).
Infektioner og parasitære sygdomme Meget almindelig Infektion (1) 
Infections and infestations Very common
Antal hændelser, n (%) Gennemsnit PFS (95 % CI) (måneder) 
Number of events, n (%) Median PFS (95 % CI) (months)
0,788 (0,671 til 0,925) 
0.788 (0.671 to 0.925)
Grad 4 hypertension (hypertensiv krise) blev indberettet hos 1 patient (0,2 %) i ZALTRAP-armen. 
Grade 4 hypertension (hypertensive crisis) was reported in 1 patient (0.2 %) treated with the ZALTRAP/FOLFIRI regimen.
Median samlet overlevelse (95 % CI) (måneder) 
Median overall survival (95 % CI) (months)
Der er observeret en højere forekomst af svær diarré hos patienter behandlet med ZALTRAP/FOLFIRI-regimet (se pkt. 
A higher incidence of severe diarrhoea has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
6,9 (6,37 til 7,20) 
6.9 (6.37 to 7.20)
Der er ikke gennemført formelle studier med ZALTRAP hos patienter med nedsat nyrefunktion. 
There have been no formal studies with ZALTRAP in patients with renal impairment.
6,9 (6,24 til 7,20) 
6.9 (6.24 to 7.20)
Baseret på studier hos aber er det sandsynligt, at mænds og kvinders fertilitet påvirkes af behandling med aflibercept (se pkt. 
Male and female fertility are likely to be compromised during treatment with aflibercept based on studies in monkeys (see section 5.3).
0,758 (0,661 til 0,869) 
0.758 (0.661 to 0.869)
Udsættelse af behandling eller dosisjustering Neutropeni eller trombocytopeni (se pkt. 
ZALTRAP/FOLFIRI Treatment delay or dose modification Neutropenia or thrombocytopenia (see sections 4.4 and 4.8)
Samlet overlevelse Antal dødsfald, n (%) Gennemsnit samlet overlevelse (95 % CI) (måneder) 
Number of death events, n (%) Median overall survival (95 % CI) (months)