natgillin/translations-raw huggingface dataset:
Andre bivirkninger, som er blevet rapporteret (hyppighed ikke kendt) med ipilimumab i kombination med nivolumab, inkluderer: afstødning af transplanterede solide organer en række stofskiftekomplikationer efter kræftbehandling karakteriseret ved høje koncentrationer af kalium og phosphat i blodet og lav koncentration af calcium i blodet (tumorlysesyndrom) en betændelseslignende sygdom (højst sandsynligt af autoimmun oprindelse), der påvirker øjnene, huden og membranerne i ørerne, hjernen og rygmarven (Vogt-Koyanagi-Harada syndrom) betændelseslignende reaktion i sækken, der ligger omkring hjertet, og ophobning af væske omkring hjertet (sygdomme i perikardiet) 
A group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium (tumour lysis syndrome) An inflammatory disorder (most likely of autoimmune origin) affecting the eyes, skin and the membranes of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome) Inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial disorders)
Ipilimumabs CL øgedes med 9 % og nivolumabs CL øgedes med 29 %, når ipilimumab 3 mg/kg blev administreret i kombination med nivolumab 1 mg/kg, hvilket ikke blev anset for klinisk relevant. 
When ipilimumab 3 mg/kg was administered in combination with nivolumab 1 mg/kg, the CL of ipilimumab was increased by 9% and the CL of nivolumab was increased by 29%, which was not considered clinically relevant.
Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af pneumonitis, herunder interstitiel lungesygdom, 6,2 % (34/547). 
In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of pneumonitis including interstitial lung disease was 6.2% (34/547).
Almindelig dyspnø, hoste Ikke almindelig respirationssvigt, akut respiratorisk distress syndromb, lungeinfiltrat, lungeødem, 
Uncommon respiratory failure, acute respiratory distress syndromeb, lung infiltration, pulmonary oedema, pneumonitis, allergic rhinitis
Almindelig sløret syn, øjensmerter Ikke almindelig uveitisc, glaslegemeblødning, iritisc, øjenødemd, blefaritisd, nedsat synsskarphed, fornemmelse af fremmedlegeme i øjet, konjunktivitis 
Uncommon uveitisc, vitreous haemorrhage, iritisc, eye oedemad, blepharitisd, reduced visual acuity, foreign body sensation in eyes, conjunctivitis
Immunrelateret endokrinopati 
Immune-related endocrinopathy
Afhængigt af sværhedsgraden af myotoksicitet skal behandlingen med ipilimumab i kombination med nivolumab udsættes eller seponeres (se pkt. 
Based on the severity of myotoxicity, ipilimumab in combination with nivolumab should be withheld or discontinued (see section 4.2), and appropriate treatment instituted.
Laboratorietestabnormiteter ved ipilimumab i kombination med nivolumab 
Laboratory abnormalities with ipilimumab in combination with nivolumab
Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af abnorme leverfunktionstests 18,5 % (101/547). 
In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of liver function test abnormalities was 18.5% (101/547).
Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af pneumonitis, herunder interstitiel lungesygdom, 7,8 % (35/448). 
In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of pneumonitis including interstitial lung disease, was 7.8% (35/448).
Ipilimumab er associeret med svære immunrelaterede neurologiske bivirkninger. 
Ipilimumab is associated with serious immune-related neurological adverse reactions.
Ved grad 2 (symptomatisk) pneumonitis bør ipilimumab i kombination med nivolumab udsættes og kortikosteroider initieres med en dosis ækvivalent med methylprednisolon 1 mg/kg/dag. 
For Grade 2 (symptomatic) pneumonitis, ipilimumab in combination with nivolumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
Det endokrine system Meget almindelig hypotyroidisme hypotyroidisme, hypertyroidisme 
Not known solid organ transplant rejectionh Endocrine disorders Very common hypothyroidism hypothyroidism, hyperthyroidism
Ved grad 2 eller 3 stigning i serumkreatinin bør ipilimumab i kombination med nivolumab udsættes, og kortikosteroider initieres med en dosis ækvivalent med methylprednisolon 0,5-1 mg/kg/dag. 
For Grade 2 or 3 serum creatinine elevation, ipilimumab in combination with nivolumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
Resolution forekom hos 37 patienter (77,1 %) med en mediantid til resolution på 13,2 uger (0,1+ 
Resolution occurred in 37 patients (77.1%) with a median time to resolution of 13.2 weeks (range: 0.1+-106.0+).
Almindelig hypopituitarisme (herunder hypofysitis)c, hypotyroidismec Ikke almindelig binyrebarkinsufficiensc, sekundær binyrebarkinsufficiensd, hypertyroidismec, hypogonadisme 
Immune system disorders Uncommon hypersensitivity Very rare anaphylactic reaction Endocrine disorders Common hypopituitarism (including hypophysitis)c, hypothyroidismc Uncommon adrenal insufficiencyc, secondary adrenocortical insufficiencyd, hyperthyroidismc, hypogonadism
Hos patienter, som fik ipilimumab 3 mg/kg monoterapi i MDX010-20, indtrådte moderat til svær eller dødelig (Grad 2-5) immunrelateret levertoksicitet mellem 3 til 9 uger efter behandlingsstart. 
In patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, time to onset of moderate to severe or fatal (Grade 2-5) immune-related hepatotoxicity ranged from 3 to 9 weeks from the start of treatment.
række af symptomer (meningitis): nakkestivhed, følsomhed over for stærkt lys og hovedpine, influenza-lignende ubehag betændelse i hjertemusklen, svaghed i hjertemusklen, væske omkring hjertet betændelse i leveren eller skjoldbruskkirtlen, små knuder af inflammationsceller (celler, der er involveret i kroppens selvforsvar mod diverse skadelige stimuli) i forskellige organer i kroppen bughulebetændelse smertefulde hudlæsioner på arme, ben og ansigt (erythema nodosum) overaktiv hypofyse nedsat funktion af biskjoldbruskkirtlen øjenbetændelse, inflammation i øjenmuskulaturen nedsat hørelse dårlig blodcirkulation som gør fingre og tæer følelsesløse eller hvide vævsskader i hænder og fødder med rødme, hævelse og blæredannelse 
triad of symptoms (meningism): neck stiffness, intolerance of bright light and headache, flu-like discomfort inflammation of the heart muscle, weakness of the heart muscle, fluid around the heart inflammation of the liver or the pancreas, nodules of inflammatory cells in various organs of your body infection within the abdomen painful skin lesions of the arms and legs and face (erythema nodosum) overactive pituitary gland decreased function of the parathyroid gland inflammation of the eye, eye muscle inflammation decreased hearing poor blood circulation which makes toes and fingers numb or pale damage to the tissues of the hands and feet resulting in redness, swelling and blisters
Ved symptomatisk hypotyroidisme bør ipilimumab i kombination med nivolumab udsættes og substitutionsbehandling med thyroideahormon initieres efter behov. 
For symptomatic hypothyroidism, ipilimumab in combination with nivolumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Hos patienter, der fik ipilimumab 3 mg/kg monoterapi i MDX010-20, indtrådte moderate til svære eller dødelige (Grad 2-5) hudbivirkninger med en mediantid på 3 uger (0,9-16 uger) efter behandlingsstart. 
In patients who received ipilimumab 3 mg/kg monotherapy in MDX010-20, the median time to onset of moderate to severe or fatal (Grade 2-5) skin adverse reactions was 3 weeks (range 0.9-16 weeks) from start of treatment.
Svær nefritis og nedsat nyrefunktion er observeret med ipilimumab i kombination med nivolumab (se pkt. 
Severe nephritis and renal dysfunction have been observed with ipilimumab in combination with nivolumab (see section 4.8).
Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af udslæt 48,8 % (267/547). 
In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af thyroidearelaterede bivirkninger 25,2 % (113/448). 
In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of thyroid disorders was 25.2% (113/448).
Almindelig hypotension, rødmen, hedeture Ikke almindelig vaskulitis, angiopatib, perifer iskæmi, ortostatisk hypotension 
Uncommon vasculitis, angiopathyb, peripheral ischaemia, orthostatic hypotension Rare temporal arteritisd
Sjælden serøs nethindeløsning serøs nethindeløsning 
Rare serous retinal detachment serous retinal detachment
Ipilimumab er associeret med alvorlig immunrelateret levertoksicitet. 
Ipilimumab is associated with serious immune-related hepatotoxicity.
Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af thyroidearelaterede bivirkninger 27,2 % (149/547). 
In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
b. Tabel over bivirkninger 
b. Tabulated list of adverse reactions
Ved symptomatisk diabetes bør ipilimumab i kombination med nivolumab udsættes og insulinbehandling initieres efter behov. 
For symptomatic diabetes, ipilimumab in combination with nivolumab should be withheld, and insulin replacement should be initiated as needed.
Nivolumab+ipilimumab (hændelser: 63/155), median og 95 % CI: N.A. (39,06; N.A.) ──Δ─── Nivolumab (hændelser: 71/171), median og 95 % CI: N.A. (40,21; N.A.) Ipilimumab (hændelser: 103/164), median og 95 % CI: 21,49 måneder (16,85; 29,08) 
Nivolumab+Ipilimumab (events: 63/155), median and 95% CI: N.A. (39.06, N.A.) ──Δ─── Nivolumab (events: 71/171), median and 95% CI: N.A. (40.21, N.A.) Ipilimumab (events: 103/164), median and 95% CI: 21.49 months (16.85, 29.08)
Hvis der opstår forværring, eller der ikke sker bedring på trods af initiering af kortikosteroider, skal kortikosteroiddosis øges op til en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag, og ipilimumab i kombination med nivolumab skal seponeres permanent. 
If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents and ipilimumab in combination with nivolumab must be permanently discontinued.
Nivolumab+ipilimumab (hændelser: 59/123), median og 95 % CI: N.A. (26,45; N.A.) ──Δ─── Nivolumab (hændelser: 71/117), median og 95 % CI: 23,46 måneder (13,01; 36,53) Ipilimumab (hændelser: 77/113), median og 95 % CI: 18,56 måneder (13,67; 23,20) 
Nivolumab+Ipilimumab (events: 59/123), median and 95% CI: N.A. (26.45, N.A.) ──Δ─── Nivolumab (events: 71/117), median and 95% CI: 23.46 months (13.01, 36.53) Ipilimumab (events: 77/113), median and 95% CI: 18.56 months (13.67, 23.20)
Hvis du har glemt at bruge YERVOY 
If you miss a dose of YERVOY
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel. 
If you have any further questions about your treatment or the use of this medicine, ask your doctor.
Hos RCC-patienter, der blev behandlet med ipilimumab 1 mg/kg i kombination med nivolumab 3 mg/kg, var hyppigheden af nefritis eller nedsat nyrefunktion 8,8 % (48/547). 
In patients treated with ipilimumab 1 mg/kg in combination with nivolumab 3 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af udslæt 65,0 % (291/448). 
In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of rash was 65.0% (291/448).
Median responsvarighedg 
Median duration of responseg
Nivolumab versus ipilimumab (primær analyse) - HR (99,5 % CI): 0,55 (0,42; 0,73); p-værdi: < 0,0001 Nivolumab+ipilimumab versus nivolumab (deskriptiv analyse) - HR (95 % CI): 0,76 (0,62; 0,95) 
Nivolumab+ipilimumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: < 0.0001 Nivolumab vs. ipilimumab (primary analysis) - HR (99.5% CI): 0.55 (0.42, 0.73); p-value: < 0.0001
Hazard ratio var ved analysetidspunktet 0,66; (99,8 % CI 0,48-0,91) med 166/425 hændelser i kombinationsarmen, og 209/422 hændelser i sunitinib-armen. 
At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for ipilimumab in combination with nivolumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
Et 10 ml hætteglas indeholder 50 mg ipilimumab. 
One 10 ml vial contains 50 mg of ipilimumab.
Ipilimumab i kombination med nivolumab (se pkt. 
Ipilimumab in combination with nivolumab (see section 4.2)
Ipilimumab skal seponeres permanent hos patienter med svær (Grad 3 eller 4) diarre eller colitis (se pkt. 
Ipilimumab must be permanently discontinued in patients with severe (Grade 3 or 4) diarrhoea or colitis (see section 4.2), and systemic high-dose intravenous corticosteroid therapy should be initiated immediately.
slangen med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske eller 50 mg/ml (5 %) glucose injektionsvæske. 
Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion.
Almindelige bivirkninger (kan forekomme hos færre end 1 ud af 10 personer) tumorsmerter nedsat funktion af skjoldbruskkirtlen, hvilket kan medføre træthed eller vægtstigning, nedsat funktion (hypopituitarisme) af eller betændelseslignende reaktion (hypofysitis) i hypofysen, der er placeret nederst i hjernen væskemangel forvirring nerveskader (medfører smerter, svaghed og kramper), svimmelhed, hovedpine sløret syn, øjensmerter lavt blodtryk, forbigående rødme i ansigtet og på halsen, intens varmefølelse med svedudbrud og hurtig hjertebanken åndenød (dyspnø), hoste blødning i maven eller tarmene, tarmbetændelse (tyktarmsbetændelse), forstoppelse, halsbrand, mavesmerter unormal leverfunktion betændelseslignende reaktion (inflammation) på indersiden af visse organer inflammation og rødme på huden, farveændringer som pletter på huden (vitiligo), nældefeber (kløende, hævet udslæt), hårtab eller udtynding af håret, voldsom nattesved, tør hud muskelsmerter og ledsmerter (artralgi), muskelkramper kulderystelser, manglende energi, væskeansamlinger (hævelse), smerter influenza‑lignende sygdom vægttab 
Common (may affect up to 1 in 10 people) tumour pain underactive function of the thyroid gland which can cause tiredness or weight gain, underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain dehydration confusion damage to the nerves (causing pain, weakness and cramps), dizziness, headache, blurred vision, pain in the eye low blood pressure, temporary redness of the face and neck, feeling of intense heat with sweating and rapid heart beat shortness of breath (dyspnoea), cough bleeding in the stomach or intestine, inflammation of the intestines (colitis), constipation, heartburn, stomach pain abnormal function of the liver inflammation of the inner surface lining of a particular organ inflammation and redness of the skin, skin colour change in patches (vitiligo), hives (itchy, bumpy rash), hair loss or thinning, excessive sweating at night, dry skin pain in muscles and joints(arthralgia), muscle spasms shivering, lack of energy, oedema (swelling), pain flu-like illness weight loss
meningisme, myokarditis, perikardieeffusion, kardiomyopati, autoimmun hepatitis, erythema nodosum, autoimmun pancreatitis, hyperpituitarisme, hypoparatyroidisme, infektiøs peritonitis, episcleritis, scleritis, Raynaudfænomen, palmar-plantar erythrodysæstesi syndrom, cytokinfrigivelsessyndrom, sarkoidose, nedsat gonadotropin, leukopeni, polycytæmi, lymfocytose, okulær myositis og neurosensorisk høretab. 
These additional reactions occurred at a frequency of < 1% unless otherwise noted: meningism, myocarditis, pericardial effusion, cardiomyopathy, autoimmune hepatitis, erythema nodosum, autoimmune pancreatitis, hyperpituitarism, hypoparathyroidism, infectious peritonitis, episcleritis, scleritis, Raynaud's phenomenon, palmar-plantar erythrodysaesthesia syndrome, cytokine release syndrome, sarcoidosis,
Ved grad 3 eller 4 pneumonitis skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 2-4 mg/kg/dag. 
For Grade 3 or 4 pneumonitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,55 (0,40; 0,75) Nivolumab versus ipilimumab - hazard ratio: 0,54 (0,40; 0,73) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 1,02 (0,73; 1,43) 
Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.55 (0.40, 0.75) Nivolumab vs. Ipilimumab - hazard ratio: 0.54 (0.40, 0.73) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 1.02 (0.73, 1.43)
Hvis der opstår forværring, eller der ikke sker bedring på trods af initiering af kortikosteroider, skal kortikosteroiddosis øges op til en dosis ækvivalent med methylprednisolon 24 mg/kg/dag, og ipilimumab i kombination med nivolumab skal seponeres permanent. 
If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and ipilimumab in combination with nivolumab must be permanently discontinued.
Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af nefritis eller nedsat nyrefunktion 5,1 % (23/448). 
In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
Undersøgelser 
Investigationsb
YERVOY 5 mg/ml koncentrat til infusionsvæske, opløsning 2. 
NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml concentrate for solution for infusion 2.
Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,59 (0,42; 0,82) Nivolumab versus ipilimumab - hazard ratio: 0,84 (0,61; 1,16) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 0,70 (0,49; 0,99) 
Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.59 (0.42, 0.82) Nivolumab vs. Ipilimumab - hazard ratio: 0.84 (0.61, 1.16) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.70 (0.49, 0.99)
De regimer, der indeholdt ipilimumab, viste en statistisk signifikant fordel over for gp100-kontrolgruppen i forhold til OS. Hazard ratio (HR) for OS var 0,66 (95 % CI: 0,51; 0,87; p = 0,0026) til fordel for ipilimumab monoterapi sammenlignet med gp100. 
The hazard ratio (HR) for comparison of OS between ipilimumab monotherapy and gp100 was 0.66 (95% CI: 0.51, 0.87; p = 0.0026).
Ved grad 4 diarré eller colitis skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag. 
For Grade 4 diarrhoea or colitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Dosis/doser udsættes, indtil symptomerne forsvinder, og behandling med kortikosteroider er afsluttetb 
Withhold dose(s) until symptoms resolve and management with corticosteroids is completeb
Alle behandlede patienter 
Two patients in the 10
Ipilimumab kan forårsage inflammation i de endokrine organer, som manifesterer sig som hypophysitis, hypopituitarisme, binyrebarkinsufficiens og hypotyroidisme (se pkt. 
Ipilimumab can cause inflammation of the endocrine system organs, manifesting as hypophysitis, hypopituitarism, adrenal insufficiency, and hypothyroidism (see section 4.8), and patients may present with nonspecific symptoms, which may resemble other causes such as brain metastasis or underlying disease.
Almindelig dehydrering, hypokaliæmi Ikke almindelig hyponatriæmi, alkalose, hypophosphatæmi, tumorlysesyndrom, hypocalcæmid 
Uncommon hyponatremia, alkalosis, hypophosphatemia, tumour lysis syndrome, hypocalcaemiad Psychiatric disorders
Sjælden polymyositisd Nyrer og urinveje Ikke almindelig nyresvigtb, glomerulonephritisc, autoimmun nefritisd, renal tubulær acidose, hæmaturid 
Musculoskeletal and connective tissue disorders Common arthralgia, myalgia, musculoskeletal painf, muscle spasms Uncommon polymyalgia rheumatica, myositisd, arthritis, muscular weaknessd Rare polymyositisd Renal and urinary disorders Uncommon renal failureb, glomerulonephritisc, autoimmune nephritisd, renal tubular acidosis, haematuriad
Ved behandlingsstart var karakteristika velbalancerede på tværs af grupperne. 
Baseline characteristics were well balanced across groups.
I fase 3‑studiet MDX010-20, (se pkt. 
In the Phase 3 study MDX010-20, (see section 5.1), patients received a median of 4 doses (range 1-4).
Ipilimumab som monoterapi (se pkt. 
Ipilimumab as monotherapy (see section 4.2)
Aktivt stof: Ipilimumab. 
What YERVOY contains The active substance is ipilimumab.
Ikke almindelig paraneoplastisk syndrom Blod og lymfesystem Almindelig anæmi, lymfopeni Ikke almindelig hæmolytisk anæmib, trombocytopeni, eosinofili, neutropeni 
Uncommon paraneoplastic syndrome Blood and lymphatic system disorders Common anaemia, lymphopenia
Ved grad 3 diarré eller colitis, som observeres med ipilimumab i kombination med nivolumab, skal behandlingen seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag. 
Grade 3 diarrhoea or colitis observed with ipilimumab in combination with nivolumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Ikke almindelig sarkoidose Ikke kendt afstødning af transplanterede solide organerh 
Solid organ transplant rejection
1 hætteglas indeholder 200 mg ipilimumab. 
Each vial contains 200 mg ipilimumab.
Ved grad 4 stigning i serumkreatinin skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider bør initieres med en dosis ækvivalent med methylprednisolon 12 mg/kg/dag. 
For Grade 4 serum creatinine elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
4.8), bør patienter, som har brug for samtidig behandling med antikoagulantia, monitoreres tæt. 
Since gastrointestinal haemorrhage is an adverse reaction with ipilimumab (see section 4.8), patients who require concomitant anticoagulant therapy should be monitored closely.
Ikke almindelig pleuraeffusion Mave-tarm-kanalen Meget almindelig colitisa, diarré, opkastning, kvalme, abdominalsmerter diarre, opkastning, kvalme 
Uncommon pleural effusion Gastrointestinal disorders Very common colitisa, diarrhoea, vomiting, nausea,
du tidligere har haft en betændelseslignende reaktion (inflammation) i lungerne. 
if you have any history of inflammation of the lungs
Ved grad 3 eller 4 forhøjelse af aminotransferase eller total-bilirubin seponeres ipilimumab i kombination med nivolumab permanent, og kortikosteroider initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag. 
For Grade 3 or 4 transaminase or total bilirubin elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.