FrancophonIA/ELRC3.0 huggingface dataset:
English: Carefully follow all instructions given to you by your doctor or nurse.
Danish: Følg nøje alle de instruktioner, du får af lægen eller sundhedspersonalet.
English: Patients should be informed about the signs and symptoms of thromboembolism and advised to contact their physician or nurse immediately if any such signs or symptoms should occur.
Danish: Patienterne bør informeres om tegn og symptomer på tromboemboli og om omgående at kontakte deres læge eller sundhedspersonalet, hvis sådanne tegn eller symptomer opstår.
English: 92284 Suresnes cedex France
Danish: 92284 Suresnes cedex Frankrig
English: This needs to be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning hos patienter, der er på en natriumkontrolleret diæt.
English: Water for injections See leaflet for further information.
Danish: Vand til injektionsvæsker Se indlægssedlen for yderligere information.
English: It is especially important that you tell your doctor if you have been given irinotecan in any form earlier.
Danish: Det er især vigtigt, at du fortæller lægen, hvis du tidligere har fået andre præparater, der indeholder irinotecan.
English: This includes any possible side effects not listed in this leaflet.
Danish: Det gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 2016
Danish: Dato for første markedsføringstilladelse: 14. oktober 2016
English: If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Ved kontakt med huden vaskes straks grundigt med vand og sæbe.
English: Hypersensitivity reactions, including acute infusion reaction may occur.
Danish: Der kan forekomme overfølsomhedsreaktioner, herunder akutte infusionsreaktioner.
English: You will need to have further (blood or other) tests during treatment so that your doctor can monitor your blood cells and assess how you are responding to the treatment.
Danish: Under behandlingen vil der blive foretaget undersøgelser (blodprøver eller andet), så lægen kan kontrollere dine blodtal og vurdere, hvordan du reagerer på behandlingen.
English: The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
Danish: Koncentratet har en pH på 7,2 og en osmolalitet på 295 mOsm/kg.
English: The LV dose does not require adjustment.
Danish: LV-dosen kræver ikke justering.
English: Neutropenic fever/neutropenic sepsis was reported in 6% of Asian patients compared to 1% of Caucasians patients.
Danish: Neutropen feber/neutropen sepsis blev rapporteret hos 6 % af de asiatiske patienter mod 1 % af de kaukasiske patienter.
English: Maximum supportive care should be instituted to prevent dehydration due to diarrhoea and to treat any infectious complications.
Danish: Maksimal understøttende behandling bør iværksættes for at forhindre dehydrering som følge af diarré og til behandling af komplikationer i forbindelse med eventuelle infektioner.
English: In certain cases, lower doses or longer dosing intervals may be required.
Danish: I nogle tilfælde kan det være nødvendigt at nedsætte dosis eller forlænge intervallerne mellem behandlingerne.
English: Neutropenia/leukopenia was the most notable important haematological toxicity.
Danish: Neutropeni/leukopeni var den vigtigste betydningsfulde hæmatologiske toksicitet.
English: Before you start treatment with ONIVYDE pegylated liposomal, your doctor will perform blood tests (or other medical examinations) to determine the best starting dose for you.
Danish: Før du påbegynder behandling med ONIVYDE pegyleret liposomal, vil lægen tage blodprøver (eller udføre andre lægeundersøgelser) for at fastsætte den bedste startdosis for dig.
English: Patient demographic and entry disease characteristics were well balanced between trial arms.
Danish: Patientdemografiske data og sygdomskarakteristika ved inklusion var velafbalanceret mellem forsøgsgrupperne.
English: The concentrate must be diluted prior to administration and given as single intravenous infusion over 90 minutes.
Danish: Koncentratet skal fortyndes før administration og indgives som en enkelt intravenøs infusion over 90 minutter.
English: Adverse reaction frequency**
Danish: Bivirkningshyppighed**
English: No data are available in patients with total bilirubin more than 2 times the ULN.
Danish: Der foreligger ingen data for patienter med total-bilirubin over 2 gange ULN.
English: The adverse reactions in these patients were similar to those reported with the recommended dosage and regimen.
Danish: Bivirkningerne hos disse patienter svarede til de bivirkninger, der er rapporteret for den anbefalede dosis og det anbefalede regime.
English: Women of childbearing potential / contraception in males and females
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder
English: In case of cholinergic symptoms atropine should be administered.
Danish: I tilfælde af kolinerge symptomer bør der gives atropin.
English: Progression-Free Survival Death or progression, n (%)
Danish: Død eller progression, n (%)
English: Common: Increased bilirubin, Increased alanine aminotransferase, Increased aspartate aminotransferase, Increased international normalised ratio
Danish: Almindelig: Forhøjet bilirubin, forhøjet alanin-aminotransferase, forhøjet aspartat-aminotransferase, forhøjet INR (international normaliseret ratio)
English: A thorough medical history should be obtained in order to identify patients with multiple risk factors in addition to the underlying neoplasm.
Danish: Der bør indhentes en grundig anamnese for at identificere patienter med flere risikofaktorer ud over den underliggende neoplasme.
English: Patients should not breast-feed until one month after the last dose.
Danish: Patienter bør først amme en måned efter den sidste dosis.
English: There have been reports of overdosage with non-liposomal irinotecan at doses up to approximately twice the recommended therapeutic dose of irinotecan, which may be fatal.
Danish: Der er rapporteret overdosering med nonliposomal irinotecan i doser op til omkring det dobbelte af den anbefalede terapeutiske dosis af irinotecan, hvilket kan være dødeligt.
English: Within each system organ class and frequency category, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt systemorganklasse og hyppighedskategori er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Per RECIST guidelines, v 1.1.
Danish: I henhold til RECIST-retningslinjer, version 1.1.
English: BATCH NUMBER
Danish: BATCHNUMMER Batch:
English: 95% CI of Rate
Danish: 95 % CI for rate
English: Myelosuppression/neutropenia
Danish: Myelosuppression/neutropeni
English: The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby allowing it to act for longer.
Danish: Det er meningen, at liposomerne skal ophobes i svulsten, hvor de frigiver lægemidlet langsomt over tid, hvilket betyder, at det virker i længere tid.
English: Each pack contains one vial with 10 ml of concentrate.
Danish: Hver pakning indeholder et hætteglas med 10 ml koncentrat.
English: Therefore, based on results from animal studies and the mechanism of action of irinotecan, ONIVYDE pegylated liposomal should not be used during pregnancy unless clearly necessary.
Danish: På baggrund af resultater fra dyrestudier og irinotecans virkningsmekanisme bør ONIVYDE pegyleret liposomal derfor ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
English: Ask your doctor for advice if you are planning to have a baby.
Danish: Spørg lægen til råds, hvis du planlægger at blive gravid.
English: Due to its mechanism of action, irinotecan is considered a potential carcinogen.
Danish: På grund af irinotecans virkningsmekanisme betragtes stoffet som potentielt karcinogent.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX19
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer, ATC-kode: L01XX19
English: In patients experiencing early diarrhoea, therapeutic and prophylactic atropine should be considered unless contraindicated.
Danish: Til patienter med tidlig diarré bør profylaktisk eller terapeutisk behandling med atropin overvejes, medmindre det er kontraindiceret.
English: Common: Hypotension
Danish: Almindelig: Hypotension
English: Mean baseline albumin level was 3.6 g/dl, and baseline KPS was 90-100 in 55% of patients.
Danish: Gennemsnitligt baseline-albuminniveau var 3,6 g/dl, og baseline-KPS var 90-100 hos 55 % af patienterne.
English: Each pack contains one vial.
Danish: Hver pakning indeholder et hætteglas.
English: Tell your doctor if you are or think you may be pregnant.
Danish: Fortæl det til lægen, hvis du er gravid eller har mistanke om, at du er gravid.
English: N=353 refers to all the subjects included in the population PK analysis Values are obtained from published data [Schaaf LJ et al. Clin Cancer Res. 2006 Jun 15;12:3782-91]
Danish: N=353 refererer til alle de forsøgspersoner, der blev inkluderet i den populationsfarmakokinetiske analyse Værdierne stammer fra publicerede data (Schaaf LJ et al. Clin Cancer Res. 2006 Jun 15;12:3782-91).
English: Patients should have loperamide (or equivalent) readily available to begin treatment for late diarrhoea.
Danish: Patienterne bør være forsynet med loperamid (eller tilsvarende) til iværksættelse af behandling for sent indsættende diarré.
English: As soon as the first liquid stool occurs, the patient should start drinking large volumes of beverages containing electrolytes.
Danish: Allerede ved den første flydende afføring skal patienten begynde at drikke store mængder væske indeholdende elektrolytter.
English: Tell your doctor or nurse about any of the following serious side effects straight away:
Danish: Fortæl straks lægen eller sundhedspersonalet, hvis du får en eller flere af følgende alvorlige bivirkninger:
English: Very common (may affect more than 1 in 10 people) - Low levels of white blood cells (neutropenia and leukopenia), Low level of red blood cells
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 patienter) - Lavt antal hvide blodlegemer (neutropeni og leukopeni), lavt antal røde blodlegemer
English: Febrile neutropenia (body temperature > 38°C and neutrophil count ≤ 1,000 cells/mm³) should be urgently treated in the hospital with broad-spectrum intravenous antibiotics.
Danish: Febril neutropeni (legemstemperatur > 38 °C og neutrofiltal ≤ 1.000 celler/mm³) bør behandles akut på hospital med bredspektrede intravenøse antibiotika.
English: Acute infusion and related reactions
Danish: Akutte infusionsreaktioner og relaterede reaktioner
English: This was not seen in morphologically normal pups.
Danish: Dette sås ikke hos morfologisk normale unger.
English: ONIVYDE pegylated liposomal must not be used instead of other medicines containing irinotecan because it behaves differently when it is contained in the liposomes than when it is given in its free form.
Danish: ONIVYDE pegyleret liposomal må ikke anvendes i stedet for andre lægemidler, som indeholder irinotecan, fordi det virker på en anden måde, når det er indkapslet i liposomer, end når det indgives i fri form.
English: Dose modifications for leukopenia and thrombocytopenia are based on NCI CTCAE toxicity grading and are the same as recommended for neutropenia above.
Danish: Dosisændringerne ved leukopeni og trombocytopeni er baseret på NCI CTCAE-toksicitetsgrader og er de samme som anbefalet ovenfor for neutropeni.
English: If ONIVYDE pegylated liposomal is used during pregnancy or if the patient becomes pregnant while receiving therapy, the patient should be informed about the potential hazard to the foetus.
Danish: Hvis ONIVYDE pegyleret liposomal anvendes under graviditet, eller hvis patienten bliver gravid under behandlingen, bør patienten informeres om den potentielle risiko for fosteret.
English: 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.
Danish: Hvis diarréen fortsætter længere end 24 timer, mens patienten tager loperamid, skal det overvejes at tilføje orale antibiotika (f.eks. fluorquinolon i 7 dage).
English: Early onset diarrhoea, typically appearing ≤ 24 hours after dose administration, can occur and is usually transient.
Danish: Der kan forekomme tidligt indsættende diarré, som typisk optræder ≤ 24 timer efter dosisadministration, og som normalt er forbigående.
English: 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).
Danish: De bivirkninger, som kan opstå under ONIVYDE pegyleret liposomal-behandling, er sammenfattet nedenfor og klassificeret efter systemorganklasse og hyppighedskategori (tabel 3).
English: What you need to know before you use ONIVYDE pegylated liposomal Follow carefully all instructions given to you by your doctor.
Danish: Det skal du vide, før du begynder at bruge ONIVYDE pegyleret liposomal Følg nøje alle de instruktioner, du får af lægen.
English: It blocks an enzyme called topoisomerase I, which is involved in the division of cell DNA.
Danish: Det blokerer enzymet topoisomerase I, som medvirker ved delingen af cellernes DNA.
English: Patients with risk factors should be closely monitored for respiratory symptoms before and during ONIVYDE pegylated liposomal therapy.
Danish: Patienter med risikofaktorer bør kontrolleres nøje for respiratoriske symptomer før og under ONIVYDE pegyleret liposomal-behandlingen.
English: Direct measurement of irinotecan shows that 95% of irinotecan remains liposome-encapsulated during circulation.
Danish: Direkte måling af liposomal irinotecan viser, at 95 % af irinotecan forbliver liposomindkapslet under cirkulation.
English: Non-liposomal irinotecan displays a large volume of distribution (138 l/m2).
Danish: Nonliposomal irinotecan udviser et højt fordelingsvolumen (138 l/m2).
English: 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.
Danish: 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.
English: Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France
Danish: Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex Frankrig
English: It is unknown whether ONIVYDE pegylated liposomal or its metabolites are excreted into human milk.
Danish: Det er ukendt, om ONIVYDE pegyleret liposomal eller dets metabolitter udskilles i human mælk.
English: 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%).
Danish: 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 %).
English: 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.
Danish: Under disse forhold var der en signifikant lineær dosisrelateret tendens til øget hyppighed af kombinationen polypper i livmoderhornenes endometrie-stroma og endometrie-stroma-sarkom.
English: 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.
Danish: 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.
English: 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.
Danish: I intent-to-treat-populationen (alle randomiserede) var medianalderen 63 år (31-87 år), 57 % var mænd, 61 % var kaukasiere, og 33 % var asiater.
English: Irinotecan belongs to a group of cancer medicines called ‘topoisomerase inhibitors'.
Danish: Irinotecan tilhører en gruppe af kræftmidler, som kaldes topoisomerasehæmmere.
English: 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.
Danish: 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.
English: Patients with UGT1A1 allele
Danish: Patienter med UGT1A1-allel
English: 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
Danish: 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.
English: Table 4: Efficacy results from NAPOLI-1 clinical study
Danish: Tabel 4: Effektresultater fra det kliniske studie NAPOLI-1
English: Cmax ng/ml t1/2 effective h
Danish: Cmax ng/ml t1/2 effective time
English: A reticulo-nodular pattern on chest X-ray was observed in a small percentage of patients enrolled in a clinical study with irinotecan.
Danish: Der blev observeret et retikulonodulært mønster ved thoraxrøntgen hos en lille procentdel af patienterne i et klinisk studie med irinotecan.
English: Risk factors include pre-existing lung disease, use of pneumotoxic medicinal products, colony stimulating factors or having previously received radiation therapy.
Danish: Risikofaktorerne er bl.a. allerede eksisterende lungesygdom, brug af pneumotoksiske lægemidler eller kolonistimulerende faktorer og tidligere strålebehandling.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Prior Whipple procedure
Danish: Tidligere Whipples operation
English: 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.
Danish: 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.
English: UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity such as the UGT1A1*28 polymorphism.
Danish: UGT1A1-aktiviteten er nedsat hos personer med genetiske polymorfier, som fører til nedsat enzymaktivitet, f.eks. UGT1A1*28-polymorfi.
English: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Cholesterol
Danish: 1,2-distearoyl-sn-glycero-3-phosphocholin (DSPC) Cholesterol
English: If diarrhoea persists for more than 48 hours, stop loperamide, monitor and replace fluid electrolytes and continue antibiotic support until resolution for accompanying symptoms.
Danish: Hvis diarréen fortsætter i mere end 48 timer, seponeres loperamid, væskeelektrolytter kontrolleres og erstattes, og antibiotikabehandlingen fortsættes, indtil ledsagesymptomerne er forsvundet.
English: ONIVYDE pegylated liposomal is not recommended for use in adolescents and children below the age of 18 years.
Danish: ONIVYDE pegyleret liposomal anbefales ikke til børn og unge under 18 år.
English: Values are estimated from population PK analysis
Danish: Værdierne er estimeret ud fra den populationsfarmakokinetiske analyse.
English: Non-liposomal irinotecan was teratogenic in rats and rabbits at doses below the human therapeutic dose.
Danish: Nonliposomal irinotecan var teratogent hos rotter og kaniner ved doser under den humane terapeutiske dosis.
English: - 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.
Danish: - 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.
English: The safety and efficacy of ONIVYDE pegylated liposomal in children and adolescents aged ≤ 18 years have not yet been established.
Danish: ONIVYDE pegyleret liposomals sikkerhed og virkning hos børn og unge ≤ 18 år er endnu ikke klarlagt.
English: New or progressive dyspnoea, cough, and fever should prompt interruption of ONIVYDE pegylated liposomal treatment, pending diagnostic evaluation.
Danish: Ny eller progressiv dyspnø, hoste og feber bør straks medføre afbrydelse af ONIVYDE pegyleret liposomal-behandlingen, indtil der er foretaget en diagnostisk evaluering.
English: 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%).
Danish: Nonliposomal irinotecans plasmaproteinbinding er moderat (30-68 %), og SN-38 er kraftigt bundet til humane plasmaproteiner (ca. 95 %).
English: 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.
Danish: Behandling af metastatisk pancreasadenokarcinom i kombination med fluoruracil (5-FU) og leucovorin (LV) til voksne patienter, som er progredieret efter gemcitabinbaseret behandling.
English: 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.
Danish: 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.
English: In clinical trials, ONIVYDE pegylated liposomal was administered at doses up to 210 mg/m to patients with various cancers.
Danish: I kliniske forsøg blev ONIVYDE pegyleret liposomal indgivet i doser på op til 210 mg/m til patienter med forskellige former for cancer.
English: The most significant adverse reactions reported were severe neutropenia and severe diarrrhoea.
Danish: De mest signifikante rapporterede bivirkninger var svær neutropeni og svær diarré.