FrancophonIA/ELRC3.0 huggingface dataset:
English: Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
Danish: Vectibix er indiceret til behandling af voksne patienter med metastatisk kolorektal cancer (mCRC) af RAS-vildtypen:
English: The recommended dose of Vectibix is 6 mg/kg of bodyweight given once every two weeks.
Danish: Den anbefalede dosis Vectibix er 6 mg/kg legemsvægt indgivet én gang hver anden uge.
English: Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter.
Danish: Vectibix skal indgives som en intravenøs infusion via en infusionspumpe med et indbygget lavt proteinbindende 0,2 eller 0,22 μm integreret filter gennem en perifer slange eller et indlagt kateter.
English: Vectibix should not be used in combination with bevacizumab (another monoclonal antibody used in cancer of the bowel) or with a chemotherapy combination known as “IFL”.
Danish: Vectibix bør ikke bruges i kombination med bevacizumab (et andet monoklonalt antistof, der bruges mod kræft i tyktarmen og endetarmen) eller med en kombination af kræftlægemidler kendt som "IFL".
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: kan ramme op til 1 ud af 100 personer
English: No pre- and post-natal development animal studies have been conducted with panitumumab.
Danish: Der er ikke udført nogen dyrestudier med panitumumab med henblik på den præ- og postnatale udvikling.
English: A predefined retrospective subset analysis of 586 patients of the 597 patients with wild-type KRAS (exon 2) mCRC was performed, where tumour samples from these patients were tested for additional RAS and BRAF mutations as previously described.
Danish: Der blev gennemført en forud defineret, retrospektiv undergruppeanalyse af 586 patienter ud af de 597 patienter med vildtype-KRAS-mCRC (exon 2), hvor tumorprøver fra disse patienter blev undersøgt for yderligere RAS- og BRAF-mutationer som tidligere beskrevet.
English: Outcome
Danish: Udfald
English: Pulmonary embolism Epistaxis
Danish: Lungeemboli Epistaxis
English: Vectibix must be administered using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter.
Danish: Vectibix skal indgives med et indbygget lavt proteinbindende 0,2 eller 0,22 μm integreret filter gennem en perifer slange eller et indlagt kateter.
English: Continuing infusion at 80% of original dose
Danish: Fortsæt infusion med 80 % af oprindelig dosis
English: Hypersensitivity1
Danish: Overfølsomhed1
English: Vectibix contains sodium
Danish: Vectibix indeholder natrium
English: Vectibix is used in the treatment of metastatic colorectal cancer (cancer of the bowel) for adult patients with a certain type of tumour known as a “Wild-type RAS tumour”.
Danish: Vectibix anvendes til behandling af metastatisk kolorektalcancer (kræft i tyktarm og endetarm) hos voksne patienter med en særlig type for tumor kendt som ”vildtype-RAS”.
English: 3 See section 4.4 Pulmonary complications
Danish: 4.4 Pulmonale komplikationer
English: Skin reactions were the most frequently occurring adverse reactions in patients receiving panitumumab in combination with chemotherapy.
Danish: Hudreaktioner var de hyppigste bivirkninger hos patienter, som fik panitumumab i kombination med kemoterapi.
English: The efficacy of Vectibix in first-line in combination with FOLFIRI was evaluated in a single-arm study of 154 patients with the primary endpoint of objective response rate (ORR).
Danish: Effekten af Vectibix i første-linje-behandling i kombination med FOLFIRI blev undersøgt i et enkelt armet studie med 154 patienter med objektiv responsrate (ORR) som det primære endepunkt.
English: A trend for OS favouring the control arm was observed in the wild-type KRAS subset of the oxaliplatin cohort (hazard ratio = 1.89; 95% CI: 1.30, 2.75).
Danish: Der observeredes en OS-tendens, der favoriserede kontrolarmen, i undergruppen med KRAS-vildtypen i oxaliplatinkohorten (hazard ratio = 1,89; 95 % CI: 1,30; 2,75).
English: Continuing infusion at 60% of original dose
Danish: Fortsæt infusion med 60 % af oprindelig dosis
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vectibix 20 mg/ml sterile concentrate panitumumab
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Vectibix 20 mg/ml sterilt koncentrat panitumumab i.v.
English: The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 91% of the patients.
Danish: Studiet blev analyseret prospektivt efter tumor-KRAS-status (exon 2), som kunne evalueres hos 91 % af patienterne.
English: All patients should be advised regarding the potential risk of panitumumab on pre- and post-natal development prior to initiation of Vectibix therapy.
Danish: Alle patienter skal inden iværksættelse af behandlingen med Vectibix rådgives om den mulige risiko ved panitumumab for så vidt angår den præ- og postnatale udvikling.
English: In the final analysis, the hazard ratio for PFS was 1.27 (95% CI: 1.06, 1.52).
Danish: I den endelige analyse var hazard ratio for PFS 1,27 (95 % CI: 1,06; 1,52).
English: The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions.
Danish: Infusionsslangen bør skylles med en natriumchloridinjektions/infusionsvæske før og efter administration af Vectibix for at undgå at blande med andre lægemidler eller injektions/infusionsvæsker.
English: Wild-type KRAS (exon 2) population
Danish: Vildtype-KRAS-population (exon 2)
English: 4 Ulcerative keratitis, skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis are panitumumab ADRs that were reported in the post-marketing setting.
Danish: 4 Ulcerativ keratitis, hudnekrose, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse er de lægemiddelbivirkninger af panitumumab, der er rapporteret efter markedsføring af præparatet.
English: Vectibix administered as a single agent or in combination with chemotherapy exhibits nonlinear pharmacokinetics.
Danish: Vectibix indgivet som et enkelt middel eller kombineret med kemoterapi udviser en ikke-lineær farmakokinetik.
English: No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) solution for injection in polyvinyl chloride bags or polyolefin bags.
Danish: Der er ikke observeret nogen uforligeligheder mellem Vectibix og 9 mg/ml (0,9 %) natriumchloridinjektionsvæske, opløsning, i polyvinylchloridposer eller polyolefinposer.
English: Subsequent to the development of severe skin and subcutaneous reactions, infectious complications including sepsis, in rare cases leading to death, cellulitis and local abscesses requiring incisions and drainage were reported.
Danish: Efter udviklingen af alvorlige hud- og subkutane reaktioner blev der rapporteret infektiøse komplikationer, herunder sepsis, i sjældne tilfælde med døden til følge, cellulitis samt lokale abscesser, hvor incisioner og drænage var påkrævet.
English: A predefined retrospective subset analysis of 143 patients of the 154 patients with wild-type KRAS (exon 2) mCRC was performed, where tumour samples from these patients were tested for additional RAS mutations.
Danish: Der blev gennemført en foruddefineret retrospektiv undergruppeanalyse af 143 patienter ud af de 154 patienter med vildtype-KRAS-mCRC (exon 2), hvor tumorprøver fra de pågældende patienter blev undersøgt for yderligere RAS-mutationer.
English: Median (months) (95% CI) Hazard ratio (95% CI) PFS
Danish: Median (måneder) (95 % CI) Hazard ratio (95 % CI) PFS
English: Skin rash most commonly occurred on the face, upper chest, and back, but could extend to the extremities.
Danish: Hududslæt forekom oftest i ansigtet, på den øvre brystkasse og ryg, men kunne også ses på ekstremiteterne.
English: • low red blood cell numbers (anaemia); low potassium levels in the blood (hypokalaemia); low magnesium levels in the blood (hypomagnesaemia);
Danish: • lavt antal røde blodlegemer (blodmangel), lave kaliumniveauer i blodet (hypokaliæmi), lave magnesiumniveauer i blodet (hypomagnesiæmi)
English: • The incidence of binding antibodies (excluding predose positive patients) was 1% as detected by the acid-dissociation ELISA and < 1% as detected by the Biacore assay;
Danish: • Hyppigheden af bindende antistoffer (eksklusive patienter, der var positive inden dosering) var 1 % påvist ved syredissociations-ELISA og < 1 % påvist ved Biacore-analysen;
English: The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 93% of the patients.
Danish: Studiet blev analyseret prospektivt efter tumor-KRAS-status (exon 2), som kunne evalueres hos 93 % af patienterne.
English: Vectibix must not be administered as an intravenous push or bolus.
Danish: Vectibix må ikke indgives som en intravenøs stød- eller bolusdosis.
English: Continuing infusion at 100% of original dose
Danish: Fortsæt infusion med 100 % af oprindelig dosis
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg apotekspersonalet, hvordan De skal bortskaffe medicinrester.
English: PHARMACEUTICAL FORM AND CONTENTS 5 mL of concentrate for solution for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 5 ml koncentrat til infusionsvæske, opløsning.
English: During or following treatment you may experience an infusion reaction.
Danish: Der kan opstå en infusionsrelateret reaktion under eller efter behandling.
English: • low white blood numbers (leucopenia); low calcium levels in the blood (hypocalcaemia); low phosphates in the blood (hypophosphataemia); high glucose in the blood (hyperglycaemia);
Danish: • lavt antal hvide blodlegemer (leukopeni), lave calciumniveauer i blodet (hypokalcæmi), lavt niveau af fosfat i blodet (hypofosfatæmi), højt glukoseindhold i blodet (blodsukker) (hyperglykæmi)
English: The data in the table below describe adverse reactions reported from clinical studies in patients with mCRC who received panitumumab as a single agent or in combination with chemotherapy (n = 2,224) and spontaneous reporting.
Danish: Nedenstående tabel beskriver bivirkninger, der er blevet rapporteret i kliniske studier med patienter med mCRC, som fik panitumumab i monoterapi eller i kombination med kemoterapi (n = 2.224), og fra spontan rapportering.
English: First-line combination with bevacizumab and oxaliplatin or irinotecan-based chemotherapy
Danish: Første-linje-kombination med bevacizumab og oxaliplatin- eller irinotecan-baseret kemoterapi
English: Median TTP (months)
Danish: Median TTP (mdr.)
English: • Each mL of concentrate contains 20 mg panitumumab.
Danish: • Hver ml koncentrat indeholder 20 mg panitumumab.
English: Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients.
Danish: Alvorlige (NCI-CTC grad 3) hudreaktioner blev indberettet for 23 %, og livstruende (NCI-CTC grad 4) hudreaktioner for < 1 % af patienterne.
English: Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions (occurring within 24 hours of an infusion) were reported in Vectibix-treated patients, including severe infusion-related reactions (NCI-CTC grade 3 and grade 4).
Danish: På tværs af kliniske studier med monoterapi og kombinationsbehandling til mCRC (n = 2.224) blev der indberettet infusionsrelaterede reaktioner (opstået inden for 24 timer efter infusion) hos de Vectibixbehandlede patienter, herunder alvorlige, infusionsrelaterede reaktioner (NCI-CTC, grad 3 og 4).
English: For clinical management of dermatological reactions, including dose modification recommendations, see section 4.4.
Danish: 4.4 vedrørende håndtering af dermatologiske reaktioner, herunder anbefalinger vedrørende dosisændring.
English: Dermatologic reactions and soft tissue toxicity
Danish: Dermatologiske reaktioner og bløddelstoksicitet
English: Eye infection Eyelid infection
Danish: Øjeninfektion Øjenlågsinfektion
English: Deep vein thrombosis Hypotension Hypertension Flushing
Danish: Dyb venetrombose Hypotension Hypertension Rødme
English: The incidence of these additional RAS mutations (KRAS exons 3, 4 and NRAS exons 2, 3, 4) in the wild-type KRAS (exon 2) population was approximately 10%.
Danish: Forekomsten af disse yderligere RAS-mutationer (KRAS-exon 3, 4 og NRAS-exon 2, 3, 4) i populationen med vildtype-KRAS (exon 2) var cirka 10 %.
English: Across all clinical trials, skin reactions occurred in approximately 94% of patients receiving Vectibix as monotherapy or in combination with chemotherapy (n = 2,224).
Danish: På tværs af alle kliniske studier opstod der hudreaktioner hos cirka 94 % af de patienter, som fik Vectibix som monoterapi eller i kombination med kemoterapi (n = 2.224).
English: Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL.
Danish: Hvert hætteglas indeholder enten 100 mg panitumumab i 5 ml eller 400 mg panitumumab i 20 ml.
English: • blood clot in the lung (pulmonary embolism) the symptoms of which may be sudden onset of shortness of breath or chest pain; nose bleed (epistaxis); blood clot in a deep vein (deep vein thrombosis); high blood pressure (hypertension); flushing;
Danish: • blodprop i lungen (lungeemboli) symptomerne på dette kan være pludselig stakåndethed eller brystsmerter, næseblod (epistaxis), blodprop i en dybtliggende blodåre (dyb venetrombose), højt blodtryk (hypertension), rødme
English: Median PFS (months)
Danish: Median PFS (mdr.)
English: For the mutant KRAS subset, the hazard ratio for PFS was 1.25 with 95% CI: 0.91-1.71.
Danish: Undergruppen med KRAS-mutationer havde en hazard ratio for PFS på 1,25 med 95 % CI: 0,91-1,71.
English: • The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and water for injections.
Danish: • Øvrige indholdsstoffer: natriumchlorid, natriumacetattrihydrat, (is)eddikesyre og vand til injektionsvæsker.
English: Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), water for injections.
Danish: Natriumchlorid, natriumacetattrihydrat, (is)eddikesyre, vand til injektionsvæsker.
English: Patients should be periodically monitored for hypomagnesaemia and accompanying hypocalcaemia prior to initiating Vectibix treatment, and periodically thereafter for up to 8 weeks after the completion of treatment (see section 4.8).
Danish: Monitoreringen skal indledes før behandlingen initieres og gennemføres regelmæssigt herefter i indtil 8 uger efter behandlingen seponeres (se pkt.
English: In patients experiencing a mild or moderate (CTCAE v 4.0 grades 1 and 2) infusion-related reaction the infusion rate should be reduced for the duration of that infusion.
Danish: Nedsæt infusionshastigheden hos patienter, der får en mild eller moderat (CTCAE v. 4.0, grad 1 og 2) infusionsrelateret reaktion under en given infusion.
English: Life-threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix.
Danish: Der er observeret livstruende og letale infektiøse komplikationer, herunder nekrotiserende fasciitis og sepsis, hos patienter, der blev behandlet med Vectibix.
English: Vectibix should not be administered in combination with IFL chemotherapy or with bevacizumabcontaining chemotherapy.
Danish: Vectibix bør ikke indgives sammen med IFL-kemoterapi eller kemoterapi indeholdende bevacizumab.
English: • blue colouration of the skin and mucous membranes (cyanosis);
Danish: • blåfarvning af hud og slimhinder (cyanose)
English: Do not shake or vigorously agitate the vial.
Danish: Hætteglasset må ikke rystes eller bevæges for meget.
English: Diarrhoea1
Danish: Diaré1
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: However, an increased number of serious adverse events were reported in elderly patients treated with Vectibix in combination with FOLFIRI (45% versus 32%) or FOLFOX (52% versus 37%) chemotherapy compared to chemotherapy alone (see section 4.4).
Danish: Der blev dog indberettet et øget antal alvorlige bivirkninger hos ældre patienter, som blev behandlet med Vectibix i kombination med kemoterapi med FOLFIRI (45 % vs. 32 %) eller FOLFOX (52 % vs. 37 %) sammenlignet med kemoterapi alene (se pkt.
English: Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy.
Danish: Dermatologiske reaktioner (herunder bivirkninger på negle), der er observeret hos patienter, som blev behandlet med Vectibix eller andre EGFR-hæmmere, vides at være forbundet med den farmakologiske virkning af behandlingen.
English: • hair loss (alopecia); mouth ulcers and cold sores (stomatitis); inflammation of the mouth
Danish: • hårtab (alopeci), mundsår og forkølelsessår (stomatitis), betændelse i munden
English: Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver ml infusionskoncentrat indeholder 0,150 mmol natrium svarende til 3,45 mg natrium.
English: Dose regulation
Danish: Dosisregulering
English: • diarrhoea; nausea; vomiting; abdominal pain; constipation; decreased appetite; decreased weight;
Danish: • diaré, kvalme, opkastning, mavesmerter, forstoppelse, nedsat appetit, vægttab
English: For clinical management of infusion-related reactions, see section 4.4.
Danish: 4.4 vedrørende information om den kliniske behandling af infusionsrelaterede reaktioner.
English: • spreading infection below the skin (cellulitis); hair follicle inflammation (folliculitis); localised infection; skin rash with pus-filled blisters (rash pustular); urinary tract infection;
Danish: • spredning af en infektion under huden (cellulitis), hårfollikelbetændelse (folliculitis), lokal infektion, hududslæt med pusfyldte blærer (pustuløst udslæt), urinvejsinfektion
English: In the post-marketing setting, serious cases of keratitis and ulcerative keratitis have been rarely reported (see section 4.4).
Danish: Efter markedsføring af præparatet er der indberettet sjældne tilfælde af alvorlig keratitis og ulcerativ keratitis (se pkt.
English: The efficacy of Vectibix in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (FOLFOX) was evaluated in a randomised, controlled trial of 1,183 patients with mCRC with the primary endpoint of PFS. Other key endpoints included the OS, ORR, time to response, time to progression (TTP), and duration of response.
Danish: Effekten af Vectibix i kombination med oxaliplatin, fluoruracil (5-FU) og leucovorin (FOLFOX) blev undersøgt i et randomiseret, kontrolleret studie med 1.183 patienter med mCRC, hvor det primære endepunkt var PFS. Andre centrale endepunkter var OS, ORR, tid indtil respons, tid indtil progression (TTP) samt responsvarighed.
English: Electrolyte disturbances
Danish: Elektrolytforstyrrelser
English: • inflammation of the lungs (interstitial lung disease).
Danish: • betændelsestilstand i lungerne (interstitiel lungesygdom)
English: Skin fissures Acne
Danish: Hudfissurer Acne
English: • dehydration;
Danish: • væskemangel (dehydrering)
English: Vectibix in combination with bevacizumab and chemotherapy regimens
Danish: Vectibix kombineret med bevacizumab og kemoterapeutiske regimer
English: Prior to infusion, Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection to a final concentration not to exceed 10 mg/mL (for preparation instructions see section 6.6).
Danish: Før infusion skal Vectibix fortyndes med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske, opløsning, til en endelig koncentration, der ikke overstiger 10 mg/ml (se pkt.
English: Among patients with wild-type RAS mCRC, PFS, OS, and ORR were improved for subjects receiving panitumumab plus chemotherapy (FOLFOX or FOLFIRI) compared with those receiving chemotherapy alone.
Danish: Blandt patienter med vildtype-RAS-mCRC blev den progressionsfrie overlevelse (PFS), den samlede overlevelse (OS) og den objektive responsrate (ORR) forbedret for patienter, der fik panitumumab plus kemoterapi (FOLFOX eller FOLFIRI), sammenlignet med dem, der fik kemoterapi alene.
English: 427 (92%) patients were evaluable for KRAS status of which 184 had mutations.
Danish: 427 (92 %) patienter var evaluerbare for så vidt angår
English: • The incidence of neutralising antibodies (excluding predose positive patients) was < 1%;
Danish: • Hyppigheden af neutraliserende antistoffer (eksklusive patienter, der var positive inden dosering) var < 1 %;
English: Growth of eyelashes Lacrimation increased Ocular hyperaemia Dry eye
Danish: Vækst af øjenvipper Øget tåreflåd Okulær hyperæmi Øjentørhed Øjenkløe
English: Other medicines and Vectibix
Danish: Brug af anden medicin sammen med Vectibix
English: Your doctor may decide to treat the rash, adjust the dose or discontinue your treatment with Vectibix.
Danish: Deres læge kan beslutte, at udslættet skal behandles, dosis skal justeres, eller at behandling med Vectibix skal ophøre.
English: How to use Vectibix
Danish: Sådan skal De bruge Vectibix
English: • chest pain; pain; chills; pain in the extremity; immune reaction (hypersensitivity); rapid heart rate (tachycardia);
Danish: • brystsmerter, smerter, kulderystelser, smerter i ekstremiteter, immunreaktion (overfølsomhed), hurtig hjerterytme (puls) (takykardi)
English: The efficacy of Vectibix in second-line in combination with irinotecan, 5-fluorouracil (5-FU) and leucovorin (FOLFIRI) was evaluated in a randomised, controlled trial of 1,186 patients with mCRC with the primary endpoints of OS and PFS. Other key endpoints included the ORR, time to response, TTP, and duration of response.
Danish: Effekten af Vectibix i anden-linje-behandling i kombination med irinotecan, fluoruracil (5-FU) og leucovorin (FOLFIRI) blev undersøgt i et randomiseret, kontrolleret studie med 1.186 patienter med mCRC med de primære endepunkter OS og PFS. Andre centrale endepunkter var ORR, tid indtil respons, TTP samt responsvarighed.
English: A greater frequency of pulmonary embolism, infections (predominantly of dermatologic origin), diarrhoea, electrolyte imbalances, nausea, vomiting and dehydration was also observed in the treatment arms using Vectibix in combination with bevacizumab and chemotherapy.
Danish: Der blev desuden observeret en større hyppighed af lungeembolier, infektioner (hovedsagelig af dermatologisk oprindelse), diaré, elektrolytforstyrrelser, kvalme, opkastning og dehydrering i behandlingsarmene, der anvendte
English: • skin ulcer; scab; excess hair growth (hypertrichosis); redness and swelling of palms of hands or soles of feet (hand-foot syndrome); excess sweating (hyperhidrosis); skin reaction (dermatitis);
Danish: • hudsår, skorpedannelse, kraftig hårvækst (hypertrikose), hudrødme og hævelse i håndfladerne eller på fodsålerne (hånd-fod-syndrom), kraftig svedtendens (hyperhidrose), hudreaktion (dermatitis)
English: Package Leaflet: Information for the user Vectibix 20 mg/mL concentrate for solution for infusion panitumumab
Danish: Indlægsseddel: Information til brugeren Vectibix 20 mg/ml koncentrat til infusionsvæske, opløsning panitumumab
English: However, an increased number of serious adverse reactions were reported in elderly patients treated with Vectibix in combination with FOLFIRI or FOLFOX chemotherapy compared to chemotherapy alone (see section 4.8).
Danish: Et øget antal alvorlige bivirkninger blev dog indberettet hos ældre patienter, der blev behandlet med Vectibix i kombination med kemoterapi med FOLFIRI eller FOLFOX sammenlignet med kemoterapi alene (se pkt.
English: The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment.
Danish: Vectibix' sikkerhed og virkning er ikke undersøgt hos patienter med nedsat nyre- eller leverfunktion.