natgillin/translations-raw huggingface dataset:
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).
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