FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 2- [ 4- (2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES buffer) Sodium chloride
Danish: 2- [ 4- (2-hydroxyethyl) piperazin-1-yl] ethansulfonsyre (HEPES-buffer) Natriumchlorid
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Cytotoxic: handle with caution and special disposal.
Danish: Cytotoksisk: Udvis forsigtighed ved håndteringen og følg særlige regler for bortskaffelse.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: 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.
Danish: Der anbefales nøje monitorering af blodtal, og myeloide vækstfaktorer bør overvejes til patienter, som tidligere har fået abdominal strålebehandling.
English: • Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.
Danish: • Der skal udvises forsigtighed for at undgå ekstravasation, og infusionsstedet skal kontrolleres for tegn på inflammation.
English: A dose increase of ONIVYDE pegylated liposomal to 70 mg/m should be considered if tolerated in subsequent cycles.
Danish: En forhøjelse af ONIVYDE pegyleret liposomal-dosis til 70 mg/m bør overvejes i efterfølgende cyklusser, hvis det tolereres.
English: ONIVYDE pegylated liposomal should be withheld if neutropenic fever occurs or the absolute neutrophil count drops below 1,500 cells/mm
Danish: ONIVYDE pegyleret liposomal-behandling skal udskydes, hvis der opstår neutropen feber, eller det absolutte neutrofiltal falder til under 1.500 celler/mm
English: ONIVYDE pegylated liposomal with food and drink
Danish: Brug af ONIVYDE pegyleret liposomal sammen med mad og drikke
English: Diarrhoea can occur early (onset in ≤ 24 hours after starting ONIVYDE pegylated liposomal) or late (> 24 hours) (see section 4.8).
Danish: Diarré kan optræde tidligt (inden for ≤ 24 timer efter start af ONIVYDE pegyleret liposomal) eller sent (> 24 timer) (se pkt.
English: Description of selected adverse reactions The following adverse reactions were observed in the NAPOLI-1 clinical study:
Danish: Beskrivelse af udvalgte bivirkninger Følgende bivirkninger blev observeret i det kliniske studie NAPOLI-1:
English: 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).
Danish: 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).
English: 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.
Danish: I toksicitetsstudier med enkeltdoser og gentagne doser på mus, rotter og hunde var målorganerne for toksicitet mave-tarm-kanalen og det hæmatologiske system.
English: ONIVYDE pegylated liposomal is not recommended for use in patients with severe renal impairment (CLcr < 30 ml/min).
Danish: ONIVYDE pegyleret liposomal anbefales ikke til patienter med svært nedsat nyrefunktion (CLcr < 30 ml/min).
English: Type I glass vial with a grey chlorobutyl stopper and an aluminium seal with a flip-off cap, containing 10 ml of concentrate.
Danish: Hætteglas (type I-glas) med en grå chlorbutylprop og aluminiumsforsegling med flip-off-låg indeholdende 10 ml koncentrat.
English: History of prior abdominal radiation increases the risk of severe neutropenia and febrile neutropenia following ONIVYDE pegylated liposomal treatment.
Danish: Tidligere abdominal strålebehandling øger risikoen for svær neutropeni og febril neutropeni efter ONIVYDE pegyleret liposomal-behandling.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 43mg/10 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 43 mg/10 ml
English: ONIVYDE pegylated liposomal should be discontinued in case of severe hypersensitivitiy reactions.
Danish: ONIVYDE pegyleret liposomal bør seponeres i tilfælde af svære overfølsomhedsreaktioner.
English: 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.
Danish: SN-38 er ca. 1.000 gange så potent som irinotecan som hæmmer af topoisomerase I, oprenset fra humane og murine tumorcellelinjer.
English: Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.
Danish: Der skal udvises forsigtighed for at undgå ekstravasation, og infusionsstedet skal kontrolleres for tegn på inflammation.
English: 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).
Danish: Det bør overvejes at erstatte disse med ikke-enzyminducerende behandlinger mindst 2 uger før initiering af ONIVYDE pegyleret liposomal-behandlingen (se pkt.
English: First occurrence
Danish: Første tilfælde
English: SN-38 is subsequently conjugated predominantly by the enzyme UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite.
Danish: SN-38 konjugeres efterfølgende overvejende af enzymet UDP-glukuronosyltransferase 1A1 (UGT1A1) og danner en glukuronidmetabolit.
English: White to slightly yellow opaque isotonic liposomal dispersion.
Danish: Hvid til svagt gul, uigennemsigtig isotonisk liposomal dispersion.
English: Table 5: Summary of mean (±standard deviation) total irinotecan and total SN-38 Analyte PK parameters
Danish: Tabel 5: Oversigt over gennemsnitlig (± standardafvigelse) total-irinotecan og total-SN-38 Analyt
English: The severity of effects was dose-related and reversible.
Danish: Sværhedsgraden var dosisrelateret, og toksiciteten var reversibel.
English: 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).
Danish: Der var ikke tilstrækkelige data for patienter med svært nedsat nyrefunktion (CLcr < 30 ml/min) til at vurdere indvirkningen på farmakokinetikken (se pkt.
English: 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.
Danish: 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.
English: For patients experiencing late diarrhoea, the median time to late diarrhoea onset was 8 days from the previous dose of ONIVYDE pegylated liposomal.
Danish: For patienter, som fik sent indsættende diarré, var mediantiden til sent indsættende diarré 8 dage efter den forudgående ONIVYDE pegyleret liposomal-dosis.
English: Irinotecan is metabolized by carboxylesterase to SN-38.
Danish: Irinotecan metaboliseres af carboxylesterase til SN-38.
English: In pregnant rats there was a decrease in placental weight and in the offspring a decrease in foetal viability and increase in behavioural abnormalities.
Danish: Hos drægtige rotter sås fald i placentavægt og i fostrenes levedygtighed samt stigning i adfærdsmæssige abnormiteter.
English: Underweight patients (body mass index < 18.5 kg/m
Danish: Undervægtige patienter (body mass index (BMI) < 18,5 kg/m
English: 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
Danish: 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
English: l/m t1/2 effective h
Danish: t1/2 effective time
English: 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.
Danish: Behandling med loperamid bør påbegyndes straks efter første tilfælde af ikkeformet eller løs afføring eller straks efter afføring hyppigere end normalt.
English: ONIVYDE pegylated liposomal has moderate influence on the ability to drive and use machines.
Danish: ONIVYDE pegyleret liposomal påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Strong CYP3A4 inhibitors should be discontinued at least 1 week prior to starting ONIVYDE pegylated liposomal therapy.
Danish: Potente CYP3A4-hæmmere bør seponeres mindst 1 uge før initiering af ONIVYDE pegyleret liposomal-behandlingen.
English: The metabolic conversion of irinotecan to the active metabolite SN-38 is mediated by carboxylesterase enzymes.
Danish: Den metaboliske konvertering af irinotecan til den aktive metabolit SN-38 medieres af carboxylesteraseenzymer.
English: The diluted solution is clear to slightly white to slightly opalescent and free from visible particles.
Danish: Den fortyndede infusionsvæske er klar til svagt hvid eller svagt opaliserende og fri for synlige partikler.
English: • 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.
Danish: • 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.
English: 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.
Danish: 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.
English: Hepatic, renal, respiratory or other toxicities
Danish: Hepatiske, renale, respiratoriske eller andre toksiciteter af grad 3 eller 4
English: Toxicity grade (value) by NCI CTCAE v 4.01
Danish: NCI CTCAE v 4.01
English: Pulmonary toxicity
Danish: Pulmonal toksicitet
English: Complete blood cell count monitoring is recommended during ONIVYDE pegylated liposomal treatment.
Danish: Komplet blodtælling anbefales under ONIVYDE pegyleret liposomal-behandlingen.
English: 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.
Danish: 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.
English: The use of gloves, goggles and protective clothing when handling or administering ONIVYDE pegylated liposomal is recommended.
Danish: Det anbefales at anvende handsker, beskyttelsesbriller og særligt arbejdstøj ved håndtering og administration af ONIVYDE pegyleret liposomal.
English: The plasma protein binding of ONIVYDE pegylated liposomal is negligible (< 0.44% of total irinotecan in ONIVYDE pegylated liposomal).
Danish: ONIVYDE pegyleret liposomals plasmaproteinbinding er ubetydelig (< 0,44 % af total irinotecan i ONIVYDE pegyleret liposomal).
English: Onivyde pegylated liposomal has been associated with thromboembolic events such as pulmonary embolism, venous thrombosis and arterial thromboembolism.
Danish: ONIVYDE pegyleret liposomal er blevet forbundet med tromboemboliske hændelser såsom lungeemboli, venetrombose og arteriel trombose.
English: 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.
Danish: I dyremodeller er det påvist, at ONIVYDE pegyleret liposomal udvider plasmaniveauet af irinotecan og forlænger eksponeringen for den aktive metabolit SN-38 på tumorstedet.
English: Common: Dyspnoea, Dysphonia
Danish: Almindelig: Dyspnø, dysfoni
English: Thrombocytopenia Leukopenia
Danish: Trombocytopeni Leukopeni
English: 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.
Danish: Nonliposomal irinotecan og SN-38 var genotoksiske in vitro i kromosomaberrationstest i CHO-celler og i in vivo-mikronukleustest hos mus.
English: Individuals who are 7/7 homozygous for the UGT1A1*28 allele are at increased risk for neutropenia from non-liposomal irinotecan.
Danish: Mennesker, som er 7/7-homozygote for UGT1A1*28-allellen, har øget risiko for neutropeni ved behandling med nonliposomal irinotecan.
English: 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.
Danish: 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.
English: There are no adequate data on the use of ONIVYDE pegylated liposomal in pregnant women.
Danish: Der er ingen relevante data fra anvendelse af ONIVYDE pegyleret liposomal til gravide kvinder.
English: * MedDRA version 14.1 ** Rare occurrence cannot be estimated from the NAPOLI-1study due to the small sample size
Danish: ** Frekvensen ”Sjælden” kan ikke estimeres i NAPOLI-1-studiet, fordi patienttallet er for lille.
English: Forty-one percent (41%) of patients treated with ONIVYDE pegylated liposomal across the clinical program were ≥ 65 years.
Danish: 41 % af de patienter, som blev behandlet med ONIVYDE pegyleret liposomal i det kliniske program, var ≥ 65 år.
English: 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.
Danish: 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.
English: In vitro studies indicate that irinotecan, SN-38 and another metabolite aminopentane carboxylic acid (APC) do not inhibit cytochrome P-450 isozymes.
Danish: In vitro-studier indikerer, at irinotecan, SN-38 og en anden metabolit, aminopentancarboxylsyre (APC), ikke hæmmer CYP-isozymer.
English: Aseptic techniques must be followed during the preparation of the infusion.
Danish: Aseptisk teknik skal anvendes under klargøring af infusionsvæsken.
English: Objective Response Rate
Danish: Objektiv responsrate
English: After you have been given ONIVYDE pegylated liposomal you will be given two other medicines, leucovorin and 5-fluorouracil.
Danish: Efter du har fået ONIVYDE pegyleret liposomal, får du to andre lægemidler, leucovorin og 5-fluoruracil.
English: • Aseptic techniques must be followed during the preparation of the infusion.
Danish: • Aseptisk teknik skal anvendes under klargøring af infusionsvæsken.
English: Abbreviations: 5-FU/LV=5-fluorouracil/leucovorin; CI=confidence interval
Danish: Forkortelser: 5-FU/LV = 5-fluoruracil/leucovorin.
English: The dose concentration and strength are different in comparison to non-liposomal irinotecans.
Danish: Dosiskoncentration og styrke er forskellige i forhold til nonliposomale formuleringer af irinotecan.
English: 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.
Danish: 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.
English: Co-administration of ONIVYDE pegylated liposomal +5-FU/LV does not alter the pharmacokinetics of ONIVYDE pegylated liposomal based on the population pharmacokinetic analysis.
Danish: Samtidig administration af ONIVYDE pegyleret liposomal og 5-FU/LV ændrer ikke de farmakokinetiske egenskaber for ONIVYDE pegyleret liposomal baseret på en populationsfarmakokinetisk analyse.
English: Patients receiving concomitant non-liposomal irinotecan and ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased SN-38 exposure by 109%.
Danish: Hos patienter, som får samtidig behandling med nonliposomal irinotecan og ketoconazol, en CYP3A4- og UGT1A1-hæmmer, er eksponeringen for SN-38 øget med 109 %.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning.
English: Patients who require further dose reduction should discontinue treatment.
Danish: Behandlingen bør seponeres hos patienter, som har behov for yderligere dosisreduktion.
English: 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).
Danish: 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).
English: In a population pharmacokinetic analysis, mild-to-moderate renal impairment had no effect on the exposure of total SN-38 after adjusting for BSA.
Danish: I en populationsfarmakokinetisk analyse havde let til moderat nedsat nyrefunktion ingen indvirkning på eksponeringen for total-SN-38 efter justering for legemsoverflade (BSA).
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: Liposome encapsulation of irinotecan extends circulation and limits distribution relative to those of the non-liposomal irinotecan.
Danish: Liposomindkapslingen af irinotecan forlænger cirkulationen og begrænser fordelingen i forhold til nonliposomal irinotecan.
English: 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.
Danish: 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).
English: 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%)].
Danish: 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 %)).
English: Neutropenia/leukopenia
Danish: Neutropeni/leukopeni
English: Patients with prior Whipple procedure
Danish: Patienter, som har fået foretaget Whipples operation
English: No interaction of ONIVYDE pegylated liposomal (irinotecan) with other medicinal products is known.
Danish: Der kendes ingen interaktioner mellem ONIVYDE pegyleret liposomal (irinotecan) og andre lægemidler.
English: There are no data on the impact of ONIVYDE pegylated liposomal on human fertility.
Danish: Der findes ingen data om indvirkningen af ONIVYDE pegyleret liposomal på human fertilitet.
English: Median PFS (months) (95% CI)
Danish: Median PFO (måneder) (95 % CI)
English: Following Grade 3 or 4 diarrhoea, the subsequent dose of ONIVYDE pegylated liposomal should be reduced, (see section 4.2).
Danish: Efter diarré af grad 3 eller 4 bør den efterfølgende ONIVYDE pegyleret liposomal-dosis reduceres (se pkt.
English: Patients randomised to ONIVYDE pegylated liposomal monotherapy received 100 mg/m as an intravenous infusion over 90 minutes every 3 weeks.
Danish: Patienter, som var randomiseret til ONIVYDE pegyleret liposomal-monoterapi, fik 100 mg/m som intravenøs infusion over 90 minutter hver tredje uge.