natgillin/translations-raw huggingface dataset:
Liposomindkapslingen af irinotecan forlænger cirkulationen og begrænser fordelingen i forhold til nonliposomal irinotecan. 
Liposome encapsulation of irinotecan extends circulation and limits distribution relative to those of the non-liposomal irinotecan.
Den populationsfarmakokinetiske analyse tyder på, at asiater har 56 % lavere gennemsnitlig steady state-koncentration af total-irinotecan end kaukasiere (henholdsvis 3,93 (95 % CI: 3,68-4,2) og 1,74 (95 % CI: 1,58-1,93) mg/l) og 8 % højere gennemsnitlig steady state-koncentration af totalSN-38 (henholdsvis 0,97 (95 % CI: 0,92-1,03) og 1,05 (95 % CI: 0,98-1,11) ng/ml). 
The population pharmacokinetic analysis suggest that Asians have 56% lower total irinotecan average steady state concentration (3.93 [95%CI: 3.68-4.2] and 1.74 [95%CI: 1.58-1.93] mg/l, respectively) and 8% higher total SN-38 average steady state concentration (0.97 [95%CI: 0.92-1.03] and 1.05 [95%CI: 0.98-1.11] ng/ml, respectively) than Caucasians.
Hos patienter, der fik ONIVYDE pegyleret liposomal + 5-FU/LV, var incidensen af neutropeni ≥ grad 3 højere hos asiatiske patienter (18 ud af 33 (55 %)) end hos kaukasiske patienter (13 ud af 73 (18 %)). 
In patients receiving ONIVYDE pegylated liposomal +5-FU/LV, the incidence of ≥ Grade 3 neutropenia was higher among Asian patients [18 of 33 (55%)] compared to Caucasians patients [13 of 73 (18%)].
Neutropeni/leukopeni 
Neutropenia/leukopenia
Patienter, som har fået foretaget Whipples operation 
Patients with prior Whipple procedure
Der kendes ingen interaktioner mellem ONIVYDE pegyleret liposomal (irinotecan) og andre lægemidler. 
No interaction of ONIVYDE pegylated liposomal (irinotecan) with other medicinal products is known.
Der findes ingen data om indvirkningen af ONIVYDE pegyleret liposomal på human fertilitet. 
There are no data on the impact of ONIVYDE pegylated liposomal on human fertility.
Median PFO (måneder) (95 % CI) 
Median PFS (months) (95% CI)
Efter diarré af grad 3 eller 4 bør den efterfølgende ONIVYDE pegyleret liposomal-dosis reduceres (se pkt. 
Following Grade 3 or 4 diarrhoea, the subsequent dose of ONIVYDE pegylated liposomal should be reduced, (see section 4.2).
Patienter, som var randomiseret til ONIVYDE pegyleret liposomal-monoterapi, fik 100 mg/m som intravenøs infusion over 90 minutter hver tredje uge. 
Patients randomised to ONIVYDE pegylated liposomal monotherapy received 100 mg/m as an intravenous infusion over 90 minutes every 3 weeks.
Hvis der opstår ekstravasation, anbefales grundig skylning af stedet med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske og/eller sterilt vand samt pålægning af is. 
Should extravasation occur, flushing the site with sodium chloride 9 mg/ml (0.9%) solution for injection and/or sterile water and applications of ice are recommended.
De primære inklusionskriterier for patienter med metastatisk pancreasadenokarcinom i NAPOLI-1-studiet var Karnofsky-performancestatus (KPS) ≥ 70, normalt bilirubinniveau, aminotransferaseniveauer ≤ 2,5 gange ULN eller ≤ 5 gange ULN for patienter med levermetastaser og albumin ≥ 3,0 g/dl. 
Key eligibility criteria for patients with metastatic adenocarcinoma of the pancreas in the NAPOLI-1 clinical study were Karnofsky Performance Status (KPS) ≥ 70, normal bilirubin level, transaminase levels ≤ 2.5 times the ULN or ≤ 5 times the ULN for patients with liver metastases and albumin ≥ 3.0 g/dl.
ONIVYDE pegyleret liposomal er et lægemiddel mod kræft, som indeholder det aktive stof irinotecan. 
ONIVYDE pegylated liposomal is a cancer medicine that contains the active substance irinotecan.
Tabel 3: Rapporterede bivirkninger ved ONIVYDE pegyleret liposomal-behandling i det kliniske studie NAPOLI-1 
Table 3: Adverse reactions reported with ONIVYDE pegylated liposomal therapy in the NAPOLI-1 clinical study
Administration af ONIVYDE pegyleret liposomal sammen med CYP3A4-induktorer kan derfor reducere den systemiske eksponering for ONIVYDE pegyleret liposomal. 
Therefore, co-administration of ONIVYDE pegylated liposomal with inducers of CYP3A4 may reduce systemic exposure of ONIVYDE pegylated liposomal.
Behandlede rotters unger med ydre abnormiteter udviste nedsat fertilitet. 
In rats, pups born from treated animals and having external abnormalities showed a decrease in fertility.
Den populationsfarmakokinetiske analyse af 196 mandlige og 157 kvindelige patienter tyder på, at køn ikke har nogen klinisk betydningsfuld effekt på eksponeringen for irinotecan og SN-38 efter justering for BSA. 
The population pharmacokinetic analysis in 196 male and 157 female patients suggests that gender had no clinically meaningful effect on the exposure to irinotecan and SN-38 after adjusting for body surface area (BSA).
ONIVYDE pegyleret liposomal leveres som en hvid til svagt gul, uigennemsigtig isotonisk liposomal dispersion i et hætteglas af glas. 
ONIVYDE pegylated liposomal is supplied as a white to slightly yellow opaque isotonic liposomal dispersion in a glass vial.
Den kumulative udskillelse af irinotecan og dets metabolitter (SN-38 og SN-38-glukuronid) i galde og urin over en periode på 48 timer efter administration af nonliposomal irinotecan til to patienter var ca. 25-50 % (100-300 mg/m 
The cumulative biliary and urinary excretion of irinotecan and its metabolites (SN-38 and SN-38 glucuronide) over a period of 48 hours following administration of non-liposomal irinotecan in two patients ranged from approximately 25% (100 mg/m2) to 50%
ONIVYDE pegyleret liposomal + 5-FU/LV (N = 117) 
ONIVYDE pegylated liposomal +5-FU/LV (N= 117)
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ONIVYDE pegyleret liposomal i alle undergrupper af den pædiatriske population ved behandling af pancreasadenokarcinom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with ONIVYDE pegylated liposomal in all subsets of the paediatric population in treatment of adenocarcinoma of the pancreas (see section 4.2 for information on paediatric use).
Du må ikke få ONIVYDE pegyleret liposomal, hvis du er gravid, da det kan skade fosteret. 
You should not be given ONIVYDE pegylated liposomal if you are pregnant as it may harm the baby.
ONIVYDE pegyleret liposomal og ikke dosiseskalerer til 70 mg/m 2, er den første anbefalede dosisreduktion til 43 mg/m og den anden til 
ONIVYDE pegylated liposomal and do not dose escalate to 70 mg/m 2, the recommended first dose reduction is to 43 mg/m and the second dose reduction is to 35 mg/m 2.
Patienter med svær knoglemarvsinsufficiens bør ikke behandles med ONIVYDE pegyleret liposomal. 
Patients with severe bone marrow failure should not be treated with ONIVYDE pegylated liposomal.
Almindelig: Lymfopeni 
Common: Lymphopenia
ONIVYDE pegyleret liposomal er et cytotoksisk lægemiddel. 
ONIVYDE pegylated liposomal is a cytotoxic medicinal product.
Patienter med nedsat bilirubinglukuronidering, f.eks. med Gilberts syndrom, kan have øget risiko for myelosuppression ved behandling med ONIVYDE pegyleret liposomal. 
Patients with deficient glucuronidation of bilirubin, such as those with Gilbert's syndrome, may be at greater risk of myelosuppression when receiving therapy with ONIVYDE pegylated liposomal.
Det aktive stof er indkapslet i små fedtpartiker, som kaldes liposomer. 
This active substance is held in tiny lipid (fatty) particles called liposomes.
Farmakokinetikken for total-irinotecan og total-SN-38 i plasma blev evalueret hos cancerpatienter, som fik ONIVYDE pegyleret liposomal som enkeltstof eller som del af kombinationskemoterapi i doser på 50-155 mg/m². 
The plasma pharmacokinetics of total irinotecan and total SN-38 were evaluated in patients with cancer who received ONIVYDE pegylated liposomal, as a single agent or as part of combination chemotherapy, at doses between 50 and 155 mg/m2.
Dosisjustering 
Dosage adjustments
ONIVYDE pegyleret liposomal bør undgås hos patienter med bilirubin > 2,0 mg/dl eller aspartataminotransferase (ASAT) og alanin-aminotransferase (ALAT) > 2,5 gange den øvre normalgrænse (ULN) eller > 5 gange ULN, hvis der forekommer levermetastaser (se pkt. 
The use of ONIVYDE pegylated liposomal should be avoided in patients with bilirubin > 2.0 mg/dl, or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) or > 5 times ULN if liver metastasis is present (see section 4.4).
ONIVYDE pegyleret liposomal skal indgives før LV efterfulgt af 5-FU. 
ONIVYDE pegylated liposomal should be administered before LV followed by 5-FU.
Almindelig: Hypoglykæmi, hyponatriæmi, hypofosfatæmi 
Common: Hypoglycaemia, Hyponatraemia, Hypophosphataemia
Tredje tilfælde 
Third occurrence
11-20 % af nonliposomal irinotecan udskilles i urinen, < 1 % af SN-38 og 3 % af SN-38-glukuronid. 
The urinary excretion of non-liposomal irinotecan is 11% to 20%; SN-38 < 1%; and SN-38 glucuronide is 3%.
Der er rapporteret infusionsreaktioner primært i form af udslæt, urticaria, periorbitalt ødem eller pruritus hos patienter i ONIVYDE pegyleret liposomal-behandling. 
Infusion reactions primarily consisting of rash, urticaria, periorbital oedema or pruritus were reported in patients receiving ONIVYDE pegylated liposomal treatment.
Indstil behandlingen med ONIVYDE pegyleret liposomal ved diarré af grad 2-4 og indled behandling af diarréen. 
Withhold ONIVYDE pegylated liposomal for Grade 2-4 diarrhoea and initiate treatment for diarrhoea.
ONIVYDE pegyleret liposomal anvendes i kombination med 2 andre kræftmidler kaldet 5-fluoruracil og leucovorin. 
ONIVYDE pegylated liposomal is used in combination with other cancer medicines, called 5-fluorouracil and leucovorin.
30 måneder. 
Unopened vial 30 months.
Rateforskel (95 % CI) p-værdi 
Rate Difference (95% CI) p-value
ONIVYDE pegyleret liposomal er til intravenøs anvendelse. 
ONIVYDE pegylated liposomal is for intravenous use.
ONIVYDE pegyleret liposomal må kun gives af læger og sundhedspersonale, som er uddannet i at give kræftmedicin. 
ONIVYDE pegylated liposomal must only be given by healthcare professionals trained in giving anticancer medicines
I kliniske studier med nonliposomal irinotecan indgivet ved en ugentlig dosering havde patienter med beskedent forhøjet total-bilirubin i serum (1,0-2,0 mg/dl) ved baseline signifikant større sandsynlighed for at få neutropeni af grad 3 eller 4 i første cyklus end patienter med et bilirubinniveau under 1,0 mg/dl. 
In clinical studies of non-liposomal irinotecan administered on a weekly dosage schedule, patients with modestly elevated baseline serum total bilirubin levels (1.0 to 2.0 mg/dl) had a significantly greater likelihood of experiencing first cycle Grade 3 or Grade 4 neutropenia than those with bilirubin levels that were less than 1.0 mg/dl.
Samlet set blev der ikke registreret væsentlige kliniske forskelle i sikkerhed og virkning mellem patienter ≥ 65 år og patienter < 65 år i NAPOLI-1-studiet, selv om seponering var hyppigere (14,8 % mod 7,9 %) i den førstnævnte gruppe, som blev behandlet med ONIVYDE pegyleret liposomal + 5-FU/LV, og i nogle tilfælde forsvandt bivirkningerne ikke. 
Overall, no major clinical differences in safety or efficacy were reported between patients ≥ 65 years and patients < 65 years, although a higher frequency of discontinuation (14.8% vs 7.9%) was noted in the former group treated with ONIVYDE pegylated liposomal +5-FU/LV in the NAPOLI-1 study and in some cases the adverse reactions did not resolve.
De farmakokinetiske (PK) parametre for total-irinotecan og total-SN-38 efter administration af 70 mg/m² ONIVYDE pegyleret liposomal er vist i tabel 5. 
The pharmacokinetic parameters of total irinotecan and SN-38 analytes, following the administration of ONIVYDE pegylated liposomal 70 mg/m are presented in Table 5.
Hvis du får ONIVYDE pegyleret liposomal, bør du først amme en måned efter den sidste dosis. 
If you are given ONIVYDE you should not breast-feed until one month after the last dose.
Det er påvist, at nonliposomal irinotecan forårsager atrofi af de hanlige og hunlige kønsorganer hos dyr efter gentagne daglige doser af irinotecan (se pkt. 
Non-liposomal irinotecan was shown to cause atrophy of male and female reproductive organs after multiple daily irinotecan doses in animals (see section 5.3).
Mediantid til nadir for neutropeni ≥ grad 3 er 23 dage (8-104) efter første ONIVYDE pegyleret liposomal-dosis. 
The median time to nadir for ≥ Grade 3 neutropenia is 23 (range 8-104) days post first dose of treatment with ONIVYDE pegylated liposomal.
ONIVYDE pegyleret liposomal-behandlingen bør udsættes, indtil diarréen er reduceret til ≤ grad 1 (2-3 afføringer mere per dag end før behandling). 
ONIVYDE pegylated liposomal treatment should be delayed until diarrhoea resolves to ≤ Grade 1 (2-3 stools/day more than pre-treatment frequency).
N-(carbonyl-methoxypolyethylenglycol-2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamin (MPEG-2000-DSPE) 
N-(carbonyl-methoxypolyethylene glycol-2000)-1, 2-distearoly-sn-glycero-3-phosphoethanolamine (MPEG-2000-DSPE)
Kolinerge reaktioner 
Cholinergic reactions
Ikke almindelig: Hypoksi 
Uncommon: Hypoxia
Asteni og anoreksi af grad 3 nødvendiggør ikke dosisjustering. 
Excludes asthenia and anorexia; asthenia and Grade 3 anorexia do not require dose adjustment.
En ny behandlingscyklus bør ikke påbegyndes, før det absolutte neutrofiltal er ≥ 1.500 celler/mm 
A new cycle of therapy should not begin until the absolute neutrophil count is ≥ 1,500 cells/mm
Første tilfælde Seponer behandlingen 
Third occurrence Discontinue treatment
Nonliposomal irinotecan forårsagede atrofi af hanlige kønsorganer hos både rotter og hunde efter gentagne daglige doser på henholdsvis 20 mg/kg og 0,4 mg/kg. 
Non-liposomal irinotecan caused atrophy of male reproductive organs both in rats and dogs after multiple daily doses of 20 mg/kg and 0.4 mg/kg, respectively.These effects were reversible upon cessation of treatment.
Før infusionen får du muligvis medicin mod kvalme og opkastning. 
You may receive pre-medication against nausea and vomiting.
I det kliniske studie forekom tidligt indsættende diarré hos 35 patienter (29,9 %), og kolinerge bivirkninger forekom hos 4 patienter (3,4 %), som fik ONIVYDE pegyleret liposomal + 5-FU/LV. 
In the clinical study, early diarrhoea onset occurred in 35 patients (29.9%) and cholinergic events occurred in 4 patients (3.4%) receiving ONIVYDE pegylated liposomal +5-FU/LV.
ONIVYDE pegyleret liposomal (liposomal irinotecan) må kun ordineres og administreres af læger og sundhedspersonale med erfaring i cancerbehandling. 
ONIVYDE pegylated liposomal (irinotecan) must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies.
Totalirinotecan 
Total irinotecan
• ONIVYDE pegyleret liposomal leveres som en steril liposomal dispersion i en koncentration på 4,3 mg/ml, som skal fortyndes før administration. 
• ONIVYDE pegylated liposomal is supplied as a sterile liposomal dispersion at a concentration of 4.3 mg/ml and must be diluted prior to administration.
• ONIVYDE pegyleret liposomal skal indgives før leucovorin efterfulgt af 5-fluoruracil. 
• ONIVYDE pegylated liposomal should be administered before leucovorin followed by 5-fluorouracil.
En ny behandlingscyklus bør ikke påbegyndes, før diarréen er reduceret til ≤ grad 1 (2-3 afføringer mere per dag end før behandling). 
A new cycle of therapy should not begin until diarrhoea resolves to ≤ Grade 1 (2-3 stools/day more than pre-treatment frequency).
Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel. 
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Forsøget var designet til at vurdere den kliniske virkning og sikkerhed af ONIVYDE pegyleret liposomal-monoterapi og ONIVYDE pegyleret liposomal + 5-FU/LV sammenlignet med en aktiv kontrolgruppe, som fik 5-FU/LV. 
The trial was designed to assess the clinical efficacy and safety of ONIVYDE pegylated liposomal monotherapy or ONIVYDE pegylated liposomal +5-FU/LV compared to an active control arm of 5-FU/LV.
Brug ikke ONIVYDE pegyleret liposomal: 
Do not use ONIVYDE pegylated liposomal:
Saccharoseoctasulfat 
Sucrose octasulphate
Meget almindelig: Hypokaliæmi, hypomagnesiæmi, dehydrering, appetitløshed 
Very common: Hypokalaemia, Hypomagnesaemia, Dehydration, Decreased appetite
Følgende bivirkninger, der betragtes som muligvis eller sandsynligvis relateret til administration af ONIVYDE pegyleret liposomal, blev rapporteret hos 264 patienter med metastatisk pancreasadenokarcinom, hvoraf 147 fik ONIVYDE pegyleret liposomal-monoterapi (100 mg/m2), og 
The following adverse reactions, considered to be possibly or probably related to the administration of ONIVYDE pegylated liposomal, were reported in 264 patients with metastatic adenocarcinoma of the pancreas, 147 of whom received ONIVYDE pegylated liposomal monotherapy (100 mg/m and 117 received ONIVYDE pegylated liposomal (70 mg/m2) in combination with 5-FU/LV.
1 ml ONIVYDE pegyleret liposomal indeholder 0,144 mmol (3,31 mg) natrium. 
Each ml of ONIVYDE pegylated liposomal contains 0.144 mmol (3.31 mg) sodium.
ONIVYDE pegyleret liposomal må ikke blandes med andre lægemidler end dem, der er anført under pkt. 
ONIVYDE pegylated liposomal must not be mixed with other medicinal products except those mentioned in section 6.6.
Der anbefales ingen dosisændring for toksicitet af grad 1 og 2. 
For Grade 1 and 2 toxicities there are no dose modifications recommended.
Andet tilfælde 
Second occurrence
Under behandlingen med ONIVYDE pegyleret liposomal og i 1 måned efter, behandlingen er stoppet, skal du bruge et sikkert præventionsmiddel, som passer dig, så du ikke bliver gravid i denne periode. 
During your ONIVYDE pegylated liposomal treatment and one month after you should choose an effective birth control method which suits you, to prevent pregnancy in this period of time.
Der skal udvises forsigtighed ved brug af ONIVYDE pegyleret liposomal til patienter med BMI < 18,5 kg/m 
Caution should be exercised when using ONIVYDE pegylated liposomal in patients with body mass index < 18.5 kg/m
Mænd skal anvende kondom under ONIVYDE pegyleret liposomal-behandlingen og i 4 måneder derefter. 
Males should use condoms during ONIVYDE pegylated liposomal treatment and 4 months thereafter.
Hvis du ved tidligere behandlinger med ONIVYDE pegyleret liposomal har oplevet kraftig sveden, mavekramper og øget spytdannelse sammen med tidligt indsættende hyppig og flydende afføring, vil du muligvis ved efterfølgende behandlinger få lægemidler for at forhindre disse bivirkninger eller nedsætte sværhedsgraden af dem, før du får ONIVYDE pegyleret liposomal. 
If you have experienced sweating, abdominal cramping and salivation together with early frequent and liquid stools in previous treatments with ONIVYDE pegylated liposomal, you may receive additional medicines before ONIVYDE pegylated liposomal to prevent or reduce this in the following treament cycles.
På baggrund af interaktionen mellem nonliposomal irinotecan og ketoconazol kan administration af ONIVYDE pegyleret liposomal sammen med andre UGT1A1-hæmmere (f.eks. atazanavir, gemfibrozil, indinavir) muligvis også øge den systemiske eksponering for ONIVYDE pegyleret liposomal. 
Based on the drug interaction of non-liposomal irinotecan and ketoconazole, co-administration of ONIVYDE pegylated liposomal with other inhibitors of UGT1A1 (e.g. atazanavir, gemfibrozil, indinavir) may also increase systemic exposure of ONIVYDE pegylated liposomal.
ONIVYDE pegyleret liposomal må ikke indgives til patienter med tarmobstruktion og kronisk inflammatorisk tarmsygdom, før denne er forsvundet. 
ONIVYDE pegylated liposomal must not be administered to patients with bowel obstruction, and chronic inflammatory bowel disease, until it is resolved.
Spørg lægen, hvis du har spørgsmål om virkningen af ONIVYDE pegyleret liposomal, eller hvorfor dette lægemiddel er blevet ordineret til dig. 
If you have any questions about how ONIVYDE pegylated liposomal works or why this medicine has been prescribed for you, ask your doctor.
Præmedicinering 
Pre-medication
I det kliniske studie, der evaluerede ONIVYDE pegyleret liposomal + 5-FU/LV, svarede hyppigheden af neutropeni ≥ grad 3 hos disse patienter (2 ud af 7 (28,6 %)) til hyppigheden hos patienter, som ikke var homozygote for UGT1A1*28-allellen, og som fik en startdosis på 70 mg/m 
In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, the frequency of ≥ Grade 3 neutropenia in these patients [2 of 7 (28.6%)] was similar to the frequency in patients not homozygous for the UGT1A1*28 allele who received a starting dose of ONIVYDE pegylated liposomal of 70 mg/m
ONIVYDE pegyleret liposomal, leucovorin og 5-fluoruracil skal indgives sekventielt. 
ONIVYDE pegylated liposomal, leucovorin and 5-fluorouracil should be administered sequentially.
Kvinder i den fertile alder skal anvende sikker kontraception under ONIVYDE pegyleret liposomal-behandlingen og i 1 måned derefter. 
Women of childbearing potential should use effective contraception during ONIVYDE pegylated liposomal treatment and 1 month thereafter.
ONIVYDE pegyleret liposomal er udelukkende til engangsbrug. 
ONIVYDE pegylated liposomal is for single use only.
I det kliniske studie, der evaluerede ONIVYDE pegyleret liposomal + 5-FU/LV, havde patienter, som havde fået foretaget Whipples operation, højere risiko for alvorlige infektioner efter behandling med ONIVYDE pegyleret liposomal + 5-FU/LV end patienter, som ikke havde fået foretaget Whipples operation (9 ud af 29 (30 %) mod 11 ud af 88 (12,5 %)). 
In the clinical study evaluating ONIVYDE pegylated liposomal +5-FU/LV, patients with a prior Whipple procedure had a higher risk of serious infections following treatment with ONIVYDE pegylated liposomal +5-FU/LV [9 of 29 (30%)] compared to 11 of 88 (12.5%) patients with no prior Whipple procedure.
t x nanog/ml 
Cmax ng/ml
Fordelingen af ONIVYDE pegyleret liposomal og nonliposomal irinotecan er ikke fuldt belyst hos mennesker. 
The disposition of ONIVYDE pegylated liposomal and non-liposomal irinotecan has not been fully elucidated in humans.
Der findes ingen kendt antidot mod overdosering af ONIVYDE pegyleret liposomal. 
There is no known antidote for overdose of ONIVYDE pegylated liposomal.
12 % af patienterne havde ikke tidligere fået metastasebehandling, 56 % af patienterne havde fået én tidligere metastasebehandling, og 32 % af patienterne havde fået to eller flere tidligere metastasebehandlinger. 
Disease characteristics included 68% of patients with liver metastases and 31% with lung metastases; 12% of patients had no prior lines of metastatic therapy, 56 % of patients had 1 prior line of metastatic therapy, 32% of patients had 2 or more prior lines of metastatic therapy.
Interaktion med potente CYP3A4-induktorer 
Interactions with strong CYP3A4 inducers
Patienter med hyperbilirubinæmi havde højere koncentrationer af total SN-38 (se pkt. 
Patients with hyperbilirubinaemia had higher concentrations for total SN-38 (see section 5.2) and therefore the risk of neutropenia is increased.
Den fortyndede infusionsvæske kan opbevares ved stuetemperatur (15-25 °C) i op til 6 timer eller i køleskab (2-8 °C) i højst 24 timer før brug. 
The diluted solution for infusion can be stored at ambient temperature (15°C to 25°C)for up to 6 hours or in the refrigerator (2ºC - 8ºC) for no more than 24 hours prior to use.
Det aktive stof i ONIVYDE pegyleret liposomal er irinotecan (en topoisomerase I-hæmmer) indkapslet i en dobbeltlags lipidvesikel (et liposom). 
The active substance in ONIVYDE pegylated liposomal is irinotecan (topoisomerase I inhibitor) encapsulated in a lipid bilayer vesicle or liposome.
Diarré og relaterede bivirkninger 
Diarrhoea and related adverse reactions
Almindelig: Søvnløshed 
Common: Insomnia