natgillin/translations-raw huggingface dataset:
UGT1A1-aktiviteten er nedsat hos personer med genetiske polymorfier, som fører til nedsat enzymaktivitet, f.eks. UGT1A1*28-polymorfi. 
UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity such as the UGT1A1*28 polymorphism.
1,2-distearoyl-sn-glycero-3-phosphocholin (DSPC) Cholesterol 
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Cholesterol
Hvis diarréen fortsætter i mere end 48 timer, seponeres loperamid, væskeelektrolytter kontrolleres og erstattes, og antibiotikabehandlingen fortsættes, indtil ledsagesymptomerne er forsvundet. 
If diarrhoea persists for more than 48 hours, stop loperamide, monitor and replace fluid electrolytes and continue antibiotic support until resolution for accompanying symptoms.
ONIVYDE pegyleret liposomal anbefales ikke til børn og unge under 18 år. 
ONIVYDE pegylated liposomal is not recommended for use in adolescents and children below the age of 18 years.
Værdierne er estimeret ud fra den populationsfarmakokinetiske analyse. 
Values are estimated from population PK analysis
Nonliposomal irinotecan var teratogent hos rotter og kaniner ved doser under den humane terapeutiske dosis. 
Non-liposomal irinotecan was teratogenic in rats and rabbits at doses below the human therapeutic dose.
- Hvis du får tegn eller symptomer på en blodprop, såsom pludselig smerte eller hævelse i et ben eller en arm, pludseligt indsættende hoste, brystsmerter eller vejrtrækningsbesvær. 
- if you experience signs or symptoms of a blood clot, like sudden pain and swelling in a leg or an arm, sudden onset of coughing, chest pain or difficulty breathing.
ONIVYDE pegyleret liposomals sikkerhed og virkning hos børn og unge ≤ 18 år er endnu ikke klarlagt. 
The safety and efficacy of ONIVYDE pegylated liposomal in children and adolescents aged ≤ 18 years have not yet been established.
Ny eller progressiv dyspnø, hoste og feber bør straks medføre afbrydelse af ONIVYDE pegyleret liposomal-behandlingen, indtil der er foretaget en diagnostisk evaluering. 
New or progressive dyspnoea, cough, and fever should prompt interruption of ONIVYDE pegylated liposomal treatment, pending diagnostic evaluation.
Nonliposomal irinotecans plasmaproteinbinding er moderat (30-68 %), og SN-38 er kraftigt bundet til humane plasmaproteiner (ca. 95 %). 
The plasma protein binding of non-liposomal irinotecan is moderate (30% to 68%), and SN-38 is highly bound to human plasma proteins (approximately 95%).
Behandling af metastatisk pancreasadenokarcinom i kombination med fluoruracil (5-FU) og leucovorin (LV) til voksne patienter, som er progredieret efter gemcitabinbaseret behandling. 
Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
Hos asiatiske patienter blev der sammenlignet med kaukasiere observeret en lavere incidens af diarré (14 ud af 73 kaukasiere (19,2 %) havde diarré ≥ grad 3, og 1 ud af 33 asiatiske patienter (3,3 %) havde diarré ≥ grad 3), men en højere incidens og højere sværhedsgrad af neutropeni. 
Compared to Caucasians, Asian patients were observed with a lower incidence of diarrhoea [14 (19.2%) out of 73 Caucasians had a ≥ Grade 3 diarrhoea, and 1 out of 33 (3.3%) Asians had a ≥ Grade 3 diarrhoea], but a higher incidence and higher severity of neutropenia.
I kliniske forsøg blev ONIVYDE pegyleret liposomal indgivet i doser på op til 210 mg/m til patienter med forskellige former for cancer. 
In clinical trials, ONIVYDE pegylated liposomal was administered at doses up to 210 mg/m to patients with various cancers.
De mest signifikante rapporterede bivirkninger var svær neutropeni og svær diarré. 
The most significant adverse reactions reported were severe neutropenia and severe diarrrhoea.
Camptotheciner er specifikke hæmmere af enzymet DNA-topoisomerase I. Irinotecan og dets aktive metabolit SN-38 binder reversibelt til topoisomerase I-DNA-komplekset og inducerer enkeltstrengs-DNA-brud, som hindrer DNA-replikation og er årsag til stoffets cytotoksiske egenskab. 
Camptothecins act as specific inhibitors of the enzyme DNA topoisomerase I. Irinotecan and its active metabolite SN-38 bind reversibly to the topoisomerase I-DNA complex and induce single-strand DNA lesions which block the DNA replication fork and are responsible for the cytotoxicity.
2- [ 4- (2-hydroxyethyl) piperazin-1-yl] ethansulfonsyre (HEPES-buffer) Natriumchlorid 
2- [ 4- (2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES buffer) Sodium chloride
I en puljet analyse af 353 patienter var højere SN-38-Cmax i plasma forbundet med øget sandsynlighed for neutropeni, og højere total-irinotecan-Cmax i plasma var forbundet med øget sandsynlighed for diarré. 
In a pooled analysis from 353 patients, higher plasma SN-38 Cmax was associated with increased likelihood of experiencing neutropenia, and higher plasma total irinotecan Cmax was associated with increased likelihood of experiencing diarrhoea.
Sikkerheden og virkningen af ONIVYDE pegyleret liposomal blev undersøgt i et multinationalt, randomiseret, åbent, kontrolleret klinisk forsøg (NAPOLI-1), der afprøvede to behandlingsregimer hos patienter med metastatisk pancreasadenokarcinom, som havde dokumenteret sygdomsprogression efter gemcitabin eller gemcitabinindeholdende behandling. 
The safety and efficacy of ONIVYDE pegylated liposomal were investigated in a multinational, randomised, open label, controlled clinical trial (NAPOLI-1) that tested two treatment regimens for patients with metastatic pancreatic adenocarcinoma who had documented disease progression after gemcitabine or gemcitabine-containing therapy.
Cytotoksisk: Udvis forsigtighed ved håndteringen og følg særlige regler for bortskaffelse. 
Cytotoxic: handle with caution and special disposal.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Der anbefales nøje monitorering af blodtal, og myeloide vækstfaktorer bør overvejes til patienter, som tidligere har fået abdominal strålebehandling. 
Close monitoring of blood counts is recommended, and the use of myeloid growth factors should be considered for patients with a history of abdominal radiation.
• Der skal udvises forsigtighed for at undgå ekstravasation, og infusionsstedet skal kontrolleres for tegn på inflammation. 
• Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.
En forhøjelse af ONIVYDE pegyleret liposomal-dosis til 70 mg/m bør overvejes i efterfølgende cyklusser, hvis det tolereres. 
A dose increase of ONIVYDE pegylated liposomal to 70 mg/m should be considered if tolerated in subsequent cycles.
ONIVYDE pegyleret liposomal-behandling skal udskydes, hvis der opstår neutropen feber, eller det absolutte neutrofiltal falder til under 1.500 celler/mm 
ONIVYDE pegylated liposomal should be withheld if neutropenic fever occurs or the absolute neutrophil count drops below 1,500 cells/mm
Brug af ONIVYDE pegyleret liposomal sammen med mad og drikke 
ONIVYDE pegylated liposomal with food and drink
Diarré kan optræde tidligt (inden for ≤ 24 timer efter start af ONIVYDE pegyleret liposomal) eller sent (> 24 timer) (se pkt. 
Diarrhoea can occur early (onset in ≤ 24 hours after starting ONIVYDE pegylated liposomal) or late (> 24 hours) (see section 4.8).
Beskrivelse af udvalgte bivirkninger Følgende bivirkninger blev observeret i det kliniske studie NAPOLI-1: 
Description of selected adverse reactions The following adverse reactions were observed in the NAPOLI-1 clinical study:
Analysen omfattede 68 patienter med moderat (CLcr 30-59 ml/min) og 147 patienter med let (CLcr 60-89 ml/min) nedsat nyrefunktion samt 135 patienter med normal nyrefunktion (CLcr > 90 ml/min). 
The analysis included 68 patients with moderate (CLcr 30-59 ml/min), 147 patients with mild (CLcr 60-89 ml/min) renal impairment, and 135 patients with normal renal function (CLcr > 90 ml/min).
I toksicitetsstudier med enkeltdoser og gentagne doser på mus, rotter og hunde var målorganerne for toksicitet mave-tarm-kanalen og det hæmatologiske system. 
In single and repeated dose toxicity studies in mice, rats and dogs, the target organs of toxicity were the gastrointestinal tract and the hematologic system.
ONIVYDE pegyleret liposomal anbefales ikke til patienter med svært nedsat nyrefunktion (CLcr < 30 ml/min). 
ONIVYDE pegylated liposomal is not recommended for use in patients with severe renal impairment (CLcr < 30 ml/min).
Hætteglas (type I-glas) med en grå chlorbutylprop og aluminiumsforsegling med flip-off-låg indeholdende 10 ml koncentrat. 
Type I glass vial with a grey chlorobutyl stopper and an aluminium seal with a flip-off cap, containing 10 ml of concentrate.
Tidligere abdominal strålebehandling øger risikoen for svær neutropeni og febril neutropeni efter ONIVYDE pegyleret liposomal-behandling. 
History of prior abdominal radiation increases the risk of severe neutropenia and febrile neutropenia following ONIVYDE pegylated liposomal treatment.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 43 mg/10 ml 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 43mg/10 ml
ONIVYDE pegyleret liposomal bør seponeres i tilfælde af svære overfølsomhedsreaktioner. 
ONIVYDE pegylated liposomal should be discontinued in case of severe hypersensitivitiy reactions.
SN-38 er ca. 1.000 gange så potent som irinotecan som hæmmer af topoisomerase I, oprenset fra humane og murine tumorcellelinjer. 
SN-38 is approximately 1,000 times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumour cell lines.
Der skal udvises forsigtighed for at undgå ekstravasation, og infusionsstedet skal kontrolleres for tegn på inflammation. 
Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.
Det bør overvejes at erstatte disse med ikke-enzyminducerende behandlinger mindst 2 uger før initiering af ONIVYDE pegyleret liposomal-behandlingen (se pkt. 
Consideration should be given to substituting with non-enzyme inducing therapies at least 2 weeks prior to initiation of ONIVYDE pegylated liposomal therapy (see section 4.5).
Første tilfælde 
First occurrence
SN-38 konjugeres efterfølgende overvejende af enzymet UDP-glukuronosyltransferase 1A1 (UGT1A1) og danner en glukuronidmetabolit. 
SN-38 is subsequently conjugated predominantly by the enzyme UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite.
Hvid til svagt gul, uigennemsigtig isotonisk liposomal dispersion. 
White to slightly yellow opaque isotonic liposomal dispersion.
Tabel 5: Oversigt over gennemsnitlig (± standardafvigelse) total-irinotecan og total-SN-38 Analyt 
Table 5: Summary of mean (±standard deviation) total irinotecan and total SN-38 Analyte PK parameters
Sværhedsgraden var dosisrelateret, og toksiciteten var reversibel. 
The severity of effects was dose-related and reversible.
Der var ikke tilstrækkelige data for patienter med svært nedsat nyrefunktion (CLcr < 30 ml/min) til at vurdere indvirkningen på farmakokinetikken (se pkt. 
There was insufficient data in patients with severe renal impairment (CLcr < 30 ml/min) to assess its effect on pharmacokinetics (see sections 4.2 and 4.4).
Du må ikke spise grapefrugt eller drikke grapefrugtjuice, mens du er i behandling med ONIVYDE pegyleret liposomal, da det kan øge virkningen af det aktive stof i ONIVYDE pegyleret liposomal. 
Avoid eating grapefruits and drinking grapefruit juice while you are receiving ONIVYDE pegylated liposomal as it may increase the availability of the active substance of ONIVYDE pegylated liposomal in your body.
For patienter, som fik sent indsættende diarré, var mediantiden til sent indsættende diarré 8 dage efter den forudgående ONIVYDE pegyleret liposomal-dosis. 
For patients experiencing late diarrhoea, the median time to late diarrhoea onset was 8 days from the previous dose of ONIVYDE pegylated liposomal.
Irinotecan metaboliseres af carboxylesterase til SN-38. 
Irinotecan is metabolized by carboxylesterase to SN-38.
Hos drægtige rotter sås fald i placentavægt og i fostrenes levedygtighed samt stigning i adfærdsmæssige abnormiteter. 
In pregnant rats there was a decrease in placental weight and in the offspring a decrease in foetal viability and increase in behavioural abnormalities.
Undervægtige patienter (body mass index (BMI) < 18,5 kg/m 
Underweight patients (body mass index < 18.5 kg/m
NOAEL (niveau uden observerede bivirkninger) hos rotter og hunde efter 90 minutters intravenøs infusion af ONIVYDE pegyleret liposomal én gang hver tredje uge i 18 uger var 155 mg/m 
The no-observed-adverse-effect level (NOAEL) in rats and dogs following 90 min intravenous infusion of ONIVYDE pegylated liposomal once every 3 weeks for 18 weeks was 155 mg/m
t1/2 effective time 
l/m t1/2 effective h
Behandling med loperamid bør påbegyndes straks efter første tilfælde af ikkeformet eller løs afføring eller straks efter afføring hyppigere end normalt. 
Loperamide should be initiated at first occurrence of poorly formed or loose stools or at the earliest onset of bowel movements more frequent than normal.
ONIVYDE pegyleret liposomal påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner. 
ONIVYDE pegylated liposomal has moderate influence on the ability to drive and use machines.
Potente CYP3A4-hæmmere bør seponeres mindst 1 uge før initiering af ONIVYDE pegyleret liposomal-behandlingen. 
Strong CYP3A4 inhibitors should be discontinued at least 1 week prior to starting ONIVYDE pegylated liposomal therapy.
Den metaboliske konvertering af irinotecan til den aktive metabolit SN-38 medieres af carboxylesteraseenzymer. 
The metabolic conversion of irinotecan to the active metabolite SN-38 is mediated by carboxylesterase enzymes.
Den fortyndede infusionsvæske er klar til svagt hvid eller svagt opaliserende og fri for synlige partikler. 
The diluted solution is clear to slightly white to slightly opalescent and free from visible particles.
• Øvrige indholdsstoffer: 1,2-distearoyl-sn-glycero-3-phosphocholin (DSPC), cholesterol, N-(carbonyl-methoxypolyethylenglycol-2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamin (MPEG-2000-DSPE),saccharoseoctasulfat, 2- [4- (2-hydroxyethyl)piperazin-1-yl] ethansulfonsyre (HEPES-buffer), natriumchlorid og vand til injektionsvæsker. 
• The other ingredients are: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC); cholesterol, N-(carbonyl-methoxypolyethylene glycol-2000)-1,2-distearoly-sn-glycero-3-phosphoethanolam ine (MPEG-2000-DSPE); Sucrose octasulphate; 2- [4- (2-Hydroxyethyl)piperazin-1-yl]ethanesulfonic acid (HEPES buffer); sodium chloride and water for injections.
ONIVYDE pegyleret liposomal bruges til behandling af voksne patienter med metastatisk bugspytkirtelkræft (kræft i bugspytkirtlen, som har spredt sig til andre steder i kroppen), som tidligere er blevet behandlet med lægemidlet gemcitabin. 
ONIVYDE pegylated liposomal is used to treat adult patients with metastatic pancreatic cancer (cancer of the pancreas that has already spread elsewhere in the body) whose previously cancer treatment included a medicine called gemcitabine.
Hepatiske, renale, respiratoriske eller andre toksiciteter af grad 3 eller 4 
Hepatic, renal, respiratory or other toxicities
NCI CTCAE v 4.01 
Toxicity grade (value) by NCI CTCAE v 4.01
Pulmonal toksicitet 
Pulmonary toxicity
Komplet blodtælling anbefales under ONIVYDE pegyleret liposomal-behandlingen. 
Complete blood cell count monitoring is recommended during ONIVYDE pegylated liposomal treatment.
Patienterne bør gøres opmærksomme på risikoen for sent indsættende diarré, som kan være svækkende og i sjældne tilfælde livstruende, eftersom vedvarende løs eller vandig afføring kan medføre dehydrering, forstyrrelser i elektrolytbalancen, kolitis, gastrointestinal ulceration, infektion og sepsis. 
Patients should be made aware of the risk of delayed diarrhoea which can be debilitating and, on rare occasions, life threatening since persistent loose or watery stools can result in dehydration, electrolyte imbalance, colitis, gastrointestinal (GI) ulceration, infection or sepsis.
Det anbefales at anvende handsker, beskyttelsesbriller og særligt arbejdstøj ved håndtering og administration af ONIVYDE pegyleret liposomal. 
The use of gloves, goggles and protective clothing when handling or administering ONIVYDE pegylated liposomal is recommended.
ONIVYDE pegyleret liposomals plasmaproteinbinding er ubetydelig (< 0,44 % af total irinotecan i ONIVYDE pegyleret liposomal). 
The plasma protein binding of ONIVYDE pegylated liposomal is negligible (< 0.44% of total irinotecan in ONIVYDE pegylated liposomal).
ONIVYDE pegyleret liposomal er blevet forbundet med tromboemboliske hændelser såsom lungeemboli, venetrombose og arteriel trombose. 
Onivyde pegylated liposomal has been associated with thromboembolic events such as pulmonary embolism, venous thrombosis and arterial thromboembolism.
I dyremodeller er det påvist, at ONIVYDE pegyleret liposomal udvider plasmaniveauet af irinotecan og forlænger eksponeringen for den aktive metabolit SN-38 på tumorstedet. 
In animal models, ONIVYDE pegylated liposomal has been shown to extend plasma levels of irinotecan and prolong the exposure to the active metabolite SN-38 at the site of the tumour.
Almindelig: Dyspnø, dysfoni 
Common: Dyspnoea, Dysphonia
Trombocytopeni Leukopeni 
Thrombocytopenia Leukopenia
Nonliposomal irinotecan og SN-38 var genotoksiske in vitro i kromosomaberrationstest i CHO-celler og i in vivo-mikronukleustest hos mus. 
Non-liposomal irinotecan and SN-38 were genotoxic in vitro in the chromosomal aberration test on CHO-cells as well as in the in vivo micronucleus test in mice.
Mennesker, som er 7/7-homozygote for UGT1A1*28-allellen, har øget risiko for neutropeni ved behandling med nonliposomal irinotecan. 
Individuals who are 7/7 homozygous for the UGT1A1*28 allele are at increased risk for neutropenia from non-liposomal irinotecan.
Kemisk og fysisk stabilitet for den fortyndede infusionsvæske er påvist ved 15-25 °C i op til 6 timer og i køleskab (2-8 °C) i højst 24 timer. 
Chemical and physical stability for the diluted solution for infusion has been demonstrated at 15-25°C for up to 6 hours or in the refrigerator (2ºC-8ºC) for no more than 24 hours.
Der er ingen relevante data fra anvendelse af ONIVYDE pegyleret liposomal til gravide kvinder. 
There are no adequate data on the use of ONIVYDE pegylated liposomal in pregnant women.
** Frekvensen ”Sjælden” kan ikke estimeres i NAPOLI-1-studiet, fordi patienttallet er for lille. 
* MedDRA version 14.1 ** Rare occurrence cannot be estimated from the NAPOLI-1study due to the small sample size
41 % af de patienter, som blev behandlet med ONIVYDE pegyleret liposomal i det kliniske program, var ≥ 65 år. 
Forty-one percent (41%) of patients treated with ONIVYDE pegylated liposomal across the clinical program were ≥ 65 years.
Modsat oplevede patienter > 75 år (n = 12) hyppigere alvorlige bivirkninger, udskydelse af dosering, dosisreduktion og seponering end patienter ≤ 75 år (n = 105) ved behandling med ONIVYDE pegyleret liposomal + 5-FU/LV i studiet med pancreasadenokarcinom. 
Conversely, patients > 75 years (n=12) experienced more frequent serious adverse reactions, dose delay, dose reduction and discontinuation compared to patients ≤ 75 years (n=105) when treated with ONIVYDE pegylated liposomal +5-FU/LV in the pancreatic adenocarcinoma study.
In vitro-studier indikerer, at irinotecan, SN-38 og en anden metabolit, aminopentancarboxylsyre (APC), ikke hæmmer CYP-isozymer. 
In vitro studies indicate that irinotecan, SN-38 and another metabolite aminopentane carboxylic acid (APC) do not inhibit cytochrome P-450 isozymes.
Aseptisk teknik skal anvendes under klargøring af infusionsvæsken. 
Aseptic techniques must be followed during the preparation of the infusion.
Objektiv responsrate 
Objective Response Rate
Efter du har fået ONIVYDE pegyleret liposomal, får du to andre lægemidler, leucovorin og 5-fluoruracil. 
After you have been given ONIVYDE pegylated liposomal you will be given two other medicines, leucovorin and 5-fluorouracil.
• Aseptisk teknik skal anvendes under klargøring af infusionsvæsken. 
• Aseptic techniques must be followed during the preparation of the infusion.
Forkortelser: 5-FU/LV = 5-fluoruracil/leucovorin. 
Abbreviations: 5-FU/LV=5-fluorouracil/leucovorin; CI=confidence interval
Dosiskoncentration og styrke er forskellige i forhold til nonliposomale formuleringer af irinotecan. 
The dose concentration and strength are different in comparison to non-liposomal irinotecans.
Der er set sepsis med neutropen feber og efterfølgende septisk shock med dødelig udgang hos patienter med metastatisk pancreasadenokarcinom, som blev behandlet med ONIVYDE pegyleret liposomal. 
Sepsis with neutropenic fever and consequent septic shock with fatal outcome has been observed in patients with metastatic pancreatic adenocarcinoma treated with ONIVYDE pegylated liposomal.
Samtidig administration af ONIVYDE pegyleret liposomal og 5-FU/LV ændrer ikke de farmakokinetiske egenskaber for ONIVYDE pegyleret liposomal baseret på en populationsfarmakokinetisk analyse. 
Co-administration of ONIVYDE pegylated liposomal +5-FU/LV does not alter the pharmacokinetics of ONIVYDE pegylated liposomal based on the population pharmacokinetic analysis.
Hos patienter, som får samtidig behandling med nonliposomal irinotecan og ketoconazol, en CYP3A4- og UGT1A1-hæmmer, er eksponeringen for SN-38 øget med 109 %. 
Patients receiving concomitant non-liposomal irinotecan and ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased SN-38 exposure by 109%.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning. 
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion.
Behandlingen bør seponeres hos patienter, som har behov for yderligere dosisreduktion. 
Patients who require further dose reduction should discontinue treatment.
Patienter, som får samtidig behandling med nonliposomal irinotecan og CYP3A4-enzyminducerende antikonvulsiva (phenytoin, phenobarbital eller carbamazepin), har væsentligt nedsat eksponering for irinotecan (AUC reduceret med 12 % ved perikon, 57-79 % ved phenytoin, phenobarbital og carbamazepin) og SN-38 (AUC reduceret med 42 % ved perikon, 36-92 % ved phenytoin, phenobarbital og carbamazepin). 
Patients receiving concomitant non-liposomal irinotecan and CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital or carbamazepine have substantially reduced exposure to irinotecan (AUC reduction by 12% with St John's wort, 57%-79% with phenytoin, phenobarbital, or carbamazepine) and SN-38 (AUC reduction by 42% with St John's wort, 36%-92% with phenytoin phenobarbital, or carbamazepine).
I en populationsfarmakokinetisk analyse havde let til moderat nedsat nyrefunktion ingen indvirkning på eksponeringen for total-SN-38 efter justering for legemsoverflade (BSA). 
In a population pharmacokinetic analysis, mild-to-moderate renal impairment had no effect on the exposure of total SN-38 after adjusting for BSA.
Hos patienter, som er kendt homozygote for UGT1A1*28, og som ikke har haft lægemiddelrelateret toksicitet i første behandlingscyklus (reduceret dosis på 50 mg/m2), kan ONIVYDE pegyleret liposomal-dosis øges til i alt 70 mg/m i efterfølgende cyklusser, baseret på den enkelte patients tolerance. 
Patients who are known to be homozygous for UGT1A1*28 and without drug related toxicities during the first cycle of therapy (reduced dose of 50 mg/m2) may have the dose of ONIVYDE pegylated liposomal increased to a total dose of 70 mg/m in subsequent cycles based on individual patient tolerance.
Ved administration til gravide kvinder kan ONIVYDE pegyleret liposomal skade fosteret, eftersom det er påvist, at det vigtigste indholdsstof, irinotecan, er embryotoksisk og teratogent hos dyr (se pkt. 
ONIVYDE pegylated liposomal can cause harm to the foetus when administered to the pregnant woman, as the main ingredient irinotecan has been shown to be embryotoxic and teratogenic in animals (see section 5.3).