natgillin/translations-raw huggingface dataset:
- 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)
Aflibercept bør seponeres hos patienter, der udvikler PRES (se pkt.
Aflibercept should be discontinued in patients that develop PRES (see section 4.2).
ZALTRAP indeholder - Aktivt stof: aflibercept.
• The active substance is aflibercept.
GI-perforation, inklusive dødelig GI-perforation, er blevet rapporteret hos patienter behandlet med aflibercept (se pkt.
GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8).
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.
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.
4.2), antidiarrépræparater og rehydrering bør institueres efter behov.
Dose modification of FOLFIRI regimen (see section 4.2), anti-diarrhoeal medicinal products, and rehydration as needed should be instituted.
Patienter med forudgående bevacizumab behandling eksklusive patienter med kun adjuverende (n (%))
Patients with no prior bevacizumab excluding adjuvant only (n ( %))
Rektal blødning Fistel (1) Aftøs stomatitis Hæmorroider Proktalgi Tandpine
Rectal haemorrhage Fistula (1) Aphthous stomatitis Haemorrhoids Proctalgia Toothache
Patienter uden forudgående bevacizumab (n (%)) Median OS (95 % CI) (måneder)
Patients with no prior bevacizumab (n (%)) Median OS (95 % CI) (months)
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.
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.
100 mg/4 ml 1 hætteglas 3 hætteglas
100 mg / 4 ml 1 vial
Blod og lymfesystem Meget almindelig Leukopeni (2) Neutropeni (1),(2) Trombocytopeni (2)
Leucopenia (2) Neutropenia (1),(2) Thrombocytopenia (2)
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.
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.
9/l (se pkt.
/ L (see section 4.2).
Kompromitteret sårheling (1)
Compromised wound healing (1)
Aflibercept bør seponeres hos patienter, der oplever en ATE (se pkt.
Aflibercept treatment should be discontinued in patients who experience an ATE (see section 4.2).
En ml koncentrat til infusionsvæske, opløsning indeholder 25 mg aflibercept*.
One ml of concentrate for solution for infusion contains 25 mg aflibercept*.
Dehydrering (alle grader) er observeret hos 9,0 % af patienterne i ZALTRAP-armen og hos 3,0 % i placeboarmen.
Dehydration (all grades) has been observed in 9.0 % of patients treated with ZALTRAP/FOLFIRI and 3.0 % of patients treated with placebo/FOLFIRI.
• Svære overfølsomhedsreaktioner (inklusive bronkospasme, dyspnø, angioødem og anafylaksi)
• Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Patienter uden forudgående bevacizumab (n (%)) Median PFS (95 % CI) (måneder)
Patients with no prior bevacizumab (n (%)) Median PFS (95 % CI) (months)
Hjerteinsufficiens og nedsat ejektionsfraktion
Cardiac failure and ejection fraction decreased
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.
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.
Kompromitteret sårheling
Compromised wound healing
• rindende næse
• runny nose
Performancestatus og komorbiditet
Performance status and co-morbidities
Fertilitetshæming
Impairment of fertility
Orofanryngeale smerter Rinorré
Oropharyngeal pain Rhinorrhoea
Arteriel tromboemboli (1) Venøs tromboemboli (1) Blødning (1)
Arterial thromboembolism (1) Venous thromboembolism (1) Haemorrhage (1)
Patienter med forudgående bevacizumab (n (%))
Patients with prior bevacizumab (n (%))
I det pivotale studie med mCRC-patienter blev der indberettet fistler (anale, enterovesikale, enterokutane, kolovaginale, intestinale) hos 9 ud af 611 patienter (1,5 %) i ZALTRAP-armen og hos 3 ud af 605 patienter (0,5 %) i placeboarmen.
In the pivotal study of MCRC patients, fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites) were reported in 9 of 611 patients (1.5 %) treated with the ZALTRAP/FOLFIRI
Stratificeret hazard-ratio (95 % CI)
Stratified hazard ratio (95 % CI)
Svære overfølsomhedsreaktioner (inklusive bronkospasme, dyspnø, angioødem og anafylaksi) (se pkt.
Severe hypersensitivity reactions (including bronchospasm, dyspnoea, angioedema, and anaphylaxis) (see sections 4.3 and 4.4)
Der er ikke gennemført formelle studier med ZALTRAP hos patienter med nedsat leverfunktion (se pkt.
There have been no formal studies with ZALTRAP in patients with renal impairment (see section 5.2).
Ikke almindelig GI-perforation (1)
GI perforation (1)
Grad 3 GI-fisteldannelse forekom hos 2 patienter, som blev behandlet med ZALTRAP (0,3 %), og hos en patient, som blev behandlet med placebo (0,2 %).
Grade 3 GI fistula formation occurred in 2 patients treated with ZALTRAP (0.3 %) and in 1 placebo-treated patient (0.2 %).
Brug af anden medicin sammen med ZALTRAP Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Fisteldannelse, både fra GI-kanalen og udenfor GI-kanalen, er forekommet hos patienter, som blev behandlet med ZALTRAP.
Fistula formation involving GI and non-GI sites has occurred in patients treated with ZALTRAP.
Grad 3-4 ATE forekom hos 1,7 % af de patienter, som blev behandlet med ZALTRAP, og hos 1,0 % af de placebobehandlede patienter (se pkt.
Grade 3-4 ATE occurred in 1.7 % of patients treated with ZALTRAP and 1.0 % of patients treated with placebo (see section
Grad 3-4 blødning inklusive GI-blødning, hæmaturi og postoperativ blødning blev indberettet hos 2,9 % af patienterne i ZALTRAP-armen og hos 1,7 % i placeboarmen.
Grade 3-4 haemorrhage including GI haemorrhage, haematuria, and post-procedural haemorrhage was reported in 2.9 % of patients receiving the ZALTRAP/FOLFIRI regimen compared with 1.7 % of patients receiving the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev kompromitteret sårheling indberettet hos 3 af patienterne (0,5 %) i ZALTRAP-armen og hos 5 af patienterne (0,8 %) i placeboarmen.
In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8 %) treated with the placebo/FOLFIRI regimen.
Holdbarhed efter fortynding i infusionspose
Shelf-life after dilution in the infusion bag
Et 8 ml hætteglas med koncentrat indeholder 200 mg aflibercept.
One 8 ml vial of concentrate contains 200 mg aflibercept.
Det skal du vide, før du begynder at bruge ZALTRAP
What you need to know before you are given ZALTRAP
I det pivotale studie med mCRC-patienter blev der indberettet neutropeni (alle grader) hos 67,8 % af patienterne i ZALTRAP-armen og hos 56,3 % i placeboarmen.
In the pivotal study of MCRC patients, neutropenia (all grades) has been reported in 67.8 % of patients treated with ZALTRAP/FOLFIRI and 56.3 % of patients treated with placebo/FOLFIRI.
Grad 3-4 GIperforation forekom hos 0,8 % af de patienter, som blev behandlet med ZALTRAP, og hos 0,2 % af de patienter, som blev behandlet med placebo (se pkt.
Grade 3-4 GI perforation events occurred in 0.8 % of patients treated with ZALTRAP and 0.2 % of patients treated with placebo (see section 4.4).
De hyppigst rapporterede bivirkninger (alle grader, ≥20 % forekomst) med mindst 2 % højere forekomst for ZALTRAP/FOLFIRI-regimet end for placebo/FOLFIRI-regimet var, med faldende frekvens: leukopeni, diarré, neutropeni, proteinuri, forhøjet aspartataminotransferase (ASAT),
The most common adverse reactions (all grades, ≥ 20 % 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 leucopenia, diarrhoea, neutropenia, proteinuria, increased aspartate aminotransferase (AST), stomatitis, fatigue, thrombocytopenia, increased alanine aminotransferase (ALT), hypertension, weight loss, decreased appetite, epistaxis, abdominal pain, dysphonia, increased serum creatinine, and headache (see Table 1).
I det pivotale studie med mCRC-patienter blev der rapporteret alle grader af VTE hos 9,3 % af patienterne i ZALTRAP-armen og hos 7,3 % i placeboarmen.
In the pivotal study of MCRC patients, all grades VTE occurred in 9.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 7.3 % of patients treated with the placebo/FOLFIRI regimen.
611 patienter blev behandlet med ZALTRAP 4 mg/kg hver anden uge (en cyklus), og 605 patienter blev behandlet med placebo/FOLFIRI.
The safety of ZALTRAP in combination with FOLFIRI was evaluated in 1,216 patients previously treated for metastatic colorectal cancer, of which 611 patients were treated with ZALTRAP 4 mg/kg every two weeks (one cycle) and 605 patients were treated with placebo/FOLFIRI in a phase III study.
Kompromitteret sårheling i grad 3 blev indberettet hos 2 af patienterne (0,3 %) i ZALTRAP-armen og hos ingen af patienterne i placeboarmen.
Grade 3 compromised wound healing was reported in 2 patients (0.3 %) treated with the ZALTRAP/FOLFIRI regimen and in none of the patients treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter er der rapporteret om svære overfølsomhedsreaktioner hos 0,3 % af patienterne i ZALTRAP-armen og hos 0,5 % i placeboarmen (se pkt.
In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in 0.3 % of patients treated with the ZALTRAP/FOLFIRI regimen and 0.5 % of patients treated with the placebo/FOLFIRI regimen (see section 4.4).
Et 4 ml hætteglas med koncentrat indeholder 100 mg aflibercept.
One 4 ml vial of concentrate contains 100 mg aflibercept.
Arteriel tromboemboli (1) Venøs tromboemboli (1)
Arterial thromboembolism (1) Venous thromboembolism (1)
Venøs tromboemboli
Venous thromboembolic events
I det pivotale studie med mCRC-patienter blev der indberettet GI-perforation (alle grader) hos 3 ud af 611 patienter i ZALTRAP-armen og hos 3 ud af 605 patienter i placeboarmen.
In the pivotal study of MCRC patients, GI perforation (all grades) was reported in 3 of 611 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 3 of 605 patients (0.5 %) treated with the placebo/FOLFIRI regimen.
I det pivotale studie med mCRC-patienter blev der indberettet blødningsepisoder (alle grader) hos 37,8 % af patienterne i ZALTRAP-armen og hos 19,0 % i placeboarmen.
In the pivotal study of MCRC patients, episodes of bleeding/haemorrhage (all grades) was reported in 37.8 % of patients treated with the ZALTRAP/FOLFIRI regimen compared to 19.0 % of patients treated with the placebo/FOLFIRI regimen.
ZALTRAP 25 mg/ml koncentrat til infusionsopløsning aflibercept
ZALTRAP 25 mg / ml concentrate for solution for infusion aflibercept
Grad 3-4 fistler forekom hos 0,2 % af de patienter, som blev behandlet med ZALTRAP, og 0,1 % af de patienter, som blev behandlet med placebo (se pkt.
Grade 3-4 fistula occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Hændelser af grad 3-4 forekom hos 11 patienter (1,8 %) i ZALTRAP-armen og hos 3 patienter (0,5 %) i placeboarmen.
Grade 3-4 events occurred in 11 patients (1.8 %) treated with the ZALTRAP/FOLFIRI regimen and 3 patients (0.5 %) treated with the placebo/FOLFIRI regimen.