natgillin/translations-raw huggingface dataset:
Hvis diarréen fortsætter længere end 24 timer, mens patienten tager loperamid, skal det overvejes at tilføje orale antibiotika (f.eks. fluorquinolon i 7 dage).
If diarrhoea persists while patient is on loperamide for more than 24 hours, adding oral antibiotic support (e.g. fluoroquinolone for 7 days) should be considered.
Der kan forekomme tidligt indsættende diarré, som typisk optræder ≤ 24 timer efter dosisadministration, og som normalt er forbigående.
Early onset diarrhoea, typically appearing ≤ 24 hours after dose administration, can occur and is usually transient.
De bivirkninger, som kan opstå under ONIVYDE pegyleret liposomal-behandling, er sammenfattet nedenfor og klassificeret efter systemorganklasse og hyppighedskategori (tabel 3).
The adverse reactions that may occur during treatment with ONIVYDE pegylated liposomal are summarised below and are presented by system organ class and frequency category (Table 3).
Det skal du vide, før du begynder at bruge ONIVYDE pegyleret liposomal Følg nøje alle de instruktioner, du får af lægen.
What you need to know before you use ONIVYDE pegylated liposomal Follow carefully all instructions given to you by your doctor.
Det blokerer enzymet topoisomerase I, som medvirker ved delingen af cellernes DNA.
It blocks an enzyme called topoisomerase I, which is involved in the division of cell DNA.
Patienter med risikofaktorer bør kontrolleres nøje for respiratoriske symptomer før og under ONIVYDE pegyleret liposomal-behandlingen.
Patients with risk factors should be closely monitored for respiratory symptoms before and during ONIVYDE pegylated liposomal therapy.
Direkte måling af liposomal irinotecan viser, at 95 % af irinotecan forbliver liposomindkapslet under cirkulation.
Direct measurement of irinotecan shows that 95% of irinotecan remains liposome-encapsulated during circulation.
Nonliposomal irinotecan udviser et højt fordelingsvolumen (138 l/m2).
Non-liposomal irinotecan displays a large volume of distribution (138 l/m2).
Det anbefales, at patienterne præmedicineres med standarddosis af dexamethason (eller et tilsvarende kortikosteroid) sammen med en 5-HT3-antagonist (eller andet antiemetikum) mindst 30 minutter før ONIVYDE pegyleret liposomal-infusionen.
It is recommended that patients receive pre-medication with standard doses of dexamethasone (or an equivalent corticosteroid) together with a 5-HT3 antagonist (or other antiemetic) at least 30 minutes prior to ONIVYDE pegylated liposomal infusion.
Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex Frankrig
Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France
Det er ukendt, om ONIVYDE pegyleret liposomal eller dets metabolitter udskilles i human mælk.
It is unknown whether ONIVYDE pegylated liposomal or its metabolites are excreted into human milk.
Bivirkninger af grad 3 eller højere og alvorlige behandlingsrelaterede bivirkninger var hyppigere hos patienter < 65 år (84,1 % og 50,8 %) end hos patienter ≥ 65 år (68,5 % og 44,4 %).
Grade 3 or higher and serious treatment emergent adverse reactions were more frequent in patients < 65 years (84.1% and 50.8%) compared to patients ≥ 65 years (68.5 % and 44.4%).
Under disse forhold var der en signifikant lineær dosisrelateret tendens til øget hyppighed af kombinationen polypper i livmoderhornenes endometrie-stroma og endometrie-stroma-sarkom.
Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas.
Den populationsfarmakokinetiske analyse af patienter i alderen 28-87 år, hvoraf 11 % var ≥ 75 år, tyder på, at alder ikke har nogen klinisk betydningsfuld effekt på eksponeringen for irinotecan og SN-38.
The population pharmacokinetic analysis in patients aged 28 to 87 years, of whom 11% were ≥75 years suggests that age had no clinically meaningful effect on the exposure to irinotecan and SN-38.
I intent-to-treat-populationen (alle randomiserede) var medianalderen 63 år (31-87 år), 57 % var mænd, 61 % var kaukasiere, og 33 % var asiater.
In the intent to treat (all randomised) population, the median age was 63 years (range 31-87 years), 57 % were males, and 61% were Caucasian and 33% were Asian.
Irinotecan tilhører en gruppe af kræftmidler, som kaldes topoisomerasehæmmere.
Irinotecan belongs to a group of cancer medicines called ‘topoisomerase inhibitors'.
Administration af levende eller levende svækkede vacciner til patienter, som er immunkompromitterede på grund af kemoterapeutika, herunder ONIVYDE pegyleret liposomal, kan medføre alvorlige og dødelige infektioner, og vaccination med levende vacciner bør derfor undgås.
Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic medicinal products including ONIVYDE pegylated liposomal may result in serious or fatal infections; therefore vaccination with a live vaccine should be avoided.
Patienter med UGT1A1-allel
Patients with UGT1A1 allele
I studier af sikkerhedsfarmakologi hos hunde havde ONIVYDE pegyleret liposomal ingen effekt på kardiovaskulære, hæmodynamiske, elektrokardiografiske eller respiratoriske parametre i doser op til 18 mg/kg eller 360 mg/m2.
In safety pharmacology studies in dogs, ONIVYDE pegylated liposomal had no effect on cardiovascular, hemodynamic, electrocardiographic, or respiratory parameters at doses up to 18 mg/kg or 360 mg/m
Tabel 4: Effektresultater fra det kliniske studie NAPOLI-1
Table 4: Efficacy results from NAPOLI-1 clinical study
Cmax ng/ml t1/2 effective time
Cmax ng/ml t1/2 effective h
Der blev observeret et retikulonodulært mønster ved thoraxrøntgen hos en lille procentdel af patienterne i et klinisk studie med irinotecan.
A reticulo-nodular pattern on chest X-ray was observed in a small percentage of patients enrolled in a clinical study with irinotecan.
Risikofaktorerne er bl.a. allerede eksisterende lungesygdom, brug af pneumotoksiske lægemidler eller kolonistimulerende faktorer og tidligere strålebehandling.
Risk factors include pre-existing lung disease, use of pneumotoxic medicinal products, colony stimulating factors or having previously received radiation therapy.
For nonliposomal irinotecan indgivet til rotter én gang om ugen i 13 uger i maksimumdosis på 150 mg/m² blev der ikke rapporteret behandlingsrelaterede tumorer 91 uger efter behandlingsafslutning.
For non-liposomal irinotecan, in rats treated once a week during 13 weeks at the maximum dose of 150 mg/m², no treatment related tumours were reported 91 weeks after the end of treatment.
Dette stemmer overens med den populationsfarmakokinetiske analyse, som viste lavere eksponering for irinotecan og højere eksponering for dets aktive metabolit SN-38 hos asiater end hos kaukasiere.
This is consistent with the population pharmacokinetic analysis that showed a lower exposure to irinotecan and a higher exposure to its active metabolite SN-38 in Asians than in Caucasians.
ONIVYDE pegyleret liposomal kan påvirke din evne til at føre motorkøretøj og betjene maskiner (fordi du kan blive søvnig, svimmel og udmattet under behandlingen med ONIVYDE pegyleret liposomal).
ONIVYDE pegylated liposomal may influence your ability to drive and use machines (as you may be sleepy, dizzy and exhausted with the use of ONIVYDE pegylated liposomal).
Tidligere Whipples operation
Prior Whipple procedure
Nye hændelser (alle af grad 1 eller 2) forekom generelt tidligt i ONIVYDE pegyleret liposomal-behandlingen, og der blev kun registreret hændelser efter den femte dosis hos 2 ud af 10 patienter.
New events (all grade 1 or grade 2) occurred generally early during ONIVYDE pegylated liposomal treatment, with only 2 out of 10 patients noted with events after the fifth dose.
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.