FrancophonIA/ELRC3.0 huggingface dataset:
English: This is determined by your height and weight.
Danish: Denne afhænger af din højde og vægt.
English: - if you have very severe liver problems.
Danish: hvis du har meget svære leverproblemer.
English: These are used to treat cancer.
Danish: De anvendes til behandling af kræft.
English: This effect has not been evaluated in humans.
Danish: Denne virkning er ikke vurderet hos mennesker.
English: Time from Randomization (Months)
Danish: Tiden fra randomisering (måneder)
English: Delay treatment until recovery to grade 1.
Danish: Udsæt behandlingen indtil restitution til grad 1.
English: If necessary, your doctor will adjust the dose during treatment.
Danish: Lægen vil om nødvendigt justere din dosis under behandlingen.
English: Unopened vial 5 years
Danish: Uåbnede hætteglas 5 år
English: Caution should be exercised when treating such patients.
Danish: Der bør derfor udvises forsigtighed ved behandling af sådanne patienter.
English: ATC code: L01DB11
Danish: ATC-kode: L01DB11
English: No specific dose adjustment is required in elderly patients (aged ≥ 65 years).
Danish: Der er ikke behov for specifik dosisjustering hos ældre (≥ 65 år).
English: Tell your doctor if you think you have any of the following reactions
Danish: Sig det til lægen, hvis du mener at have nogen af følgende reaktioner
English: There are no data from the use of pixantrone in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af pixantron til gravide kvinder.
English: When these symptoms go away or improve, the infusion can be continued.
Danish: Når symptomerne svinder eller bliver bedre, kan infusionen fortsætte.
English: ORR (CR, Cru, and
Danish: ORR (CR, Cru og
English: No local tolerance study was conducted.
Danish: Der er ikke udført studier af lokal tolerance.
English: This is equivalent to 50% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 50 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: Secondary malignancy (including reports of AML and MDS)
Danish: Sekundær maglinitet (inklusive rapporter om AML og MDS)
English: Your doctor will monitor your heart function if there is any sign or symptom of your heart being affected.
Danish: Lægen skal overvåge din hjertefunktion, hvis der er tegn eller symptomer på, at dit hjerte bliver påvirket.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/764/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/764/001
English: There is currently no information on the safety and efficacy of patients with poor performance status (ECOG > 2).
Danish: Der foreligger ikke på nuværende tidspunkt oplysninger om sikkerheden og virkningen hos patienter med lav performance status (ECOG > 2).
English: If extravasation occurs the administration should be stopped immediately and restarted in another vein.
Danish: Ved ekstravasation skal administrationen straks standses og genoptages i en anden vene.
English: Except for a transient increase in exposure in females after the third cycle, there were no marked differences in pharmacokinetic parameters.
Danish: Bortset fra en forbigående stigning i eksponeringen hos hundyr efter den tredje cyklus var der ingen markante forskelle i farmakokinetiske parametre.
English: Patient demographics and baseline disease characteristics were well balanced between the treatment groups, and no statistically significant differences were noted.
Danish: Patienternes demografiske karakteristika og baselinesygdomskarakteristika var velafbalanceret mellem behandlingsgrupperne, og der blev ikke fundet statistisk signifikante forskelle.
English: Acetylated metabolites are the major biotransformation products of pixantrone.
Danish: Acetylerede metabolitter er de vigtigste biotransformationsprodukter af pixantron.
English: Tumour response was assessed by a blinded independent central review panel according to the international workshop to standardise response criteria for NHL.
Danish: Tumorresponsen blev vurderet af et blindet uafhængigt centralt vurderingspanel i henhold til den internationale workshop om standardisering af responskriterierne for NHL.
English: Acetylated metabolites were pharmacologically inactive and metabolically stable.
Danish: De acetylerede metabolitter var farmakologisk inaktive og metabolisk stabile.
English: Detailed instructions for users
Danish: Detaljerede anvisninger for brugerne
English: The safety of intrathecal use has not been established.
Danish: Sikkerheden ved intratekal anvendelse er ikke klarlagt.
English: AUC (0-24h) (ng.hr/ml )
Danish: AUC (0-24h) (ng.t/ml )
English: Skin sensitivity to sunlight
Danish: Hudoverfølsomhed over for sollys
English: Tell your doctor if you take medicines such as:
Danish: Fortæl det til lægen hvis du bruger lægemidler såsom:
English: Patients with poor performance status
Danish: Patienter med lav performance status
English: Patients with serum creatinine > 2 x Upper Limit of the Normal range (ULN) were excluded from the randomised studies.
Danish: Patienter med serumkreatinin > 2 x øvre normalgrænse (ULN) blev udelukket fra de randomiserede studier.
English: This is extremely important as using more than one medicine at the same time can strengthen or weaken their effect.
Danish: Dette er yderst vigtigt, da lægemidlers virkning kan forstærkes eller svækkes, hvis man bruger flere lægemidler samtidigt.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter "Exp".
English: No long-term animal studies have been performed to establish the carcinogenic potential of Pixuvri.
Danish: Der er ikke udført langtidsforsøg i dyr til bestemmelse af det carcinogene potentiale af Pixuvri.
English: * LLN: Lower Limit of the Normal range ** ANC: Absolute Neutrophil Count
Danish: * LLN: Nedre normalgrænse ** ANC: Absolut neutrofiltal
English: Women of childbearing potential Women of childbearing potential and their partners should be advised to avoid pregnancies.
Danish: Kvinder i den fertile alder Kvinder i den fertile alder og deres partnere bør tilrådes at undgå graviditet.
English: No other significant clinically relevant interactions with CYPP450s were observed.
Danish: Der er ikke iagttaget andre klinisk relevante interaktioner med CYP P450systemet.
English: Do not give this medicine to children under the age of 18 years because there is no information about Pixuvri treatment in children and adolescents.
Danish: Dette lægemiddel må ikke gives til børn under 18 år, da er ikke findes oplysninger om brug af Pixuvri til behandling af børn og unge.
English: This will take approximately one hour unless otherwise stated.
Danish: Hvor længe infusionen tager Den vil tage ca. 1 time, medmindre du får andet at vide.
English: Therefore, metabolism does not appear to be an important elimination pathway for pixantrone.
Danish: Metabolisering synes derfor ikke at være en vigtig eliminationsvej for pixantron.
English: * NYHA: New York Heart Association ** LVEF: Left Ventricular Ejection Fraction
Danish: * NYHA: New York Heart Association ** LVEF: Venstre ventrikels uddrivningsfraktion
English: Overall Survival Probability
Danish: Samlet sandsynlighed for overlevelse
English: It is used for patients whose cancer does not respond or has returned after they have received other chemotherapy treatments.
Danish: Det anvendes til patienter med kræft, som behandlingen ikke virker på, eller som er vendt tilbage, efter at de har fået anden kemoterapibehandling.
English: No drug interactions have been reported in human subjects and no drug-drug interaction studies in humans have been performed.
Danish: Der er ikke beskrevet lægemiddelinteraktioner hos mennesker, og der er ikke udført lægemiddelinteraktionsstudier hos mennesker.
English: If overdose occurs, supportive management is recommended.
Danish: I tilfælde af overdosering anbefales støttende behandling.
English: Similar findings were reported in rats, and in dogs at 116 mg/m2.
Danish: Tilsvarende fund blev gjort hos rotter samt hos hunde ved 116 mg/m2.
English: Table 4 Summary of response per independent assessment panel (ITT population) End-of-Treatment
Danish: Tabel 4 Sammenfatning af respons efter uafhængigt vurderingspanel (ITT-populationen) Ved behandlingens slutning
English: To avoid the risk of long term infertility, sperm banking should be considered.
Danish: For at imødegå risikoen for langvarig infertilitet bør man overveje deponering i en sædbank.
English: Dark blue lyophilised powder.
Danish: Mørkeblåt frysetørret pulver.
English: Severe myelosuppression may occur.
Danish: Svær myelosuppression kan forekomme.
English: The amount of Pixuvri in milligrams that is to be administered to a patient should be determined on the basis of the patient's body surface area (BSA).
Danish: Den mængde Pixuvri i mg, der skal administreres til en patient, bør bestemmes på grundlag af patientens legemsoverflade (BSA).
English: The dose modifications should be considered (see section 4.2).
Danish: Der bør overvejes dosisjusteringer (se pkt.
English: READ ENTIRE PREPARATION INSTRUCTIONS PRIOR TO RECONSTITUTION
Danish: LÆS ALLE ANVISNINGERNE FØR REKONSTITUTION
English: The BSA should be determined using the institutional standard for BSA calculation and should use a weight measured on day 1 of every cycle.
Danish: BSA bør bestemmes i henhold til den internationale standard for beregning af BSA, som baseres på den målte kropsvægt på dag 1 afhver cyklus.
English: Compatibility with other diluents has not been determined.
Danish: Foreneligheden med andre fortyndingsvæsker er ikke klarlagt.
English: Other common toxicities
Danish: Andre almindelige toksiske virkninger
English: Pixuvri has been shown to cause phototoxic effects on 3T3 cells in vitro.
Danish: Pixuvri er påvist at medføre fototoksiske virkninger på 3T3-celler in vitro.
English: The infusion may need to be slowed down or stopped.
Danish: I så fald kan det være nødvendigt at standse infusionen eller give den langsommere.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Reconstitute and dilute before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Skal rekonstitueres og fortyndes inden brug.
English: The recommended dose is 50 mg/m2.
Danish: Den anbefalede dosis er 50 mg/m2.
English: During treatment with pixantrone, you should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment).
Danish: Når du i behandling med pixantron, bør du begrænse eller undgå udsættelse for naturligt eller kunstigt sollys (solarier eller behandling med UVA/B).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Pixuvri has a deep blue colour and for several days after receiving Pixuvri, your skin and eyes may develop a bluish discolouration, and your urine may have a bluish discolouration.
Danish: Pixuvri har en dybblå farve, og i nogle dage efter, at du har fået Pixuvri vil din hud og dine øjne muligvis være farvet blå, og din urin vil muligvis også være blålig.
English: ADRs are listed in Table 3 below by MedDRA system organ class and by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).
Danish: systemorganklasse og hyppighed: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000), meget sjælden (< 1/10 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Experience with pixantrone is limited to patients with LVEF ≥ 45% with most patients having values ≥ 50%.
Danish: Erfaringerne med pixantron er begrænset til patienter med LVEF ≥ 45 %, og hos de fleste patienter er værdien ≥ 50 %.
English: Some caution is advised in obese patients as data on BSA- based dosing is very limited for this group.
Danish: Der rådes til forsigtighed hos adipøse patienter, da data om dosering på grundlag af BSA er meget begrænsede for denne gruppe.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Danish: Anvendes det ikke straks, er brugeren ansvarlig for opbevaringstid og -betingelser før brug, og opbevarestiden vil normalt ikke være over 24 timer ved 2 °C til 8 °C, medmindre en rekonstitutionen og fortyndingen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Table 2 Treatment modifications for non-hematologic toxicities
Danish: Tabel 2 Behandlingsjustering ved ikke-hæmatologisk toksicitet
English: Dose modification and the timing of subsequent doses should be determined by clinical judgement depending on the degree and duration of myelosuppression.
Danish: Dosisjustering og tidspunktet for efterfølgende doser bør fastsættes efter et klinisk skøn baseret på myelosuppressionens grad og varighed.
English: Breast-feeding It is unknown whether Pixuvri/metabolites are excreted in human milk.
Danish: Amning Det er ukendt, om Pixuvri/metabolitter udskilles i human mælk.
English: * ADRs discussed below
Danish: * Bivirkninger gennemgås nedenfor
English: Recombinant hematopoietic growth factors may be used according to institutional or European Society for Medical Oncology (ESMO) guidelines.
Danish: Rekombinante hæmopoietiske vækstfaktorer kan anvendes efter behandlingsfacilitetens egne retningslinjer eller retningslinjerne for European Society for Medical Oncology (ESMO).
English: Following intravenous administration, plasma concentrations of pixantrone reached the maximal concentration at the end of infusion and then declined poly-exponentially.
Danish: Ved intravenøs administration nåede plasmakoncentrationerne af pixantron maksimum ved infusionens slutning og faldt derefter polyeksponentielt.
English: Whilst the effect on fertility has not been ascertained, a precaution will be to advise male patients to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment to allow new sperm to mature.
Danish: Skønt virkningen på fertiliteten ikke er bekræftet, kan mandlige patienter som sikkerhedsforanstaltning tilrådes at bruge kontraception (fortrinsvis barrieremetoden) under behandlingen og i en periode på seks måneder efter behandlingen for at tillade modning af nye spermier.
English: Before the infusion is administered you may be given medicines to prevent or reduce possible reactions to Pixuvri, such as medicines to prevent sickness.
Danish: Før infusionen gives, skal du have medicin til at forebygge eller mindske eventuelle reaktioner mod Pixuvri, herunder medicin til forebyggelse af kvalme.
English: Distribution Pixuvri has a large volume of distribution of 25.8 l and is approximately 50% bound to plasma proteins.
Danish: Fordeling Pixuvri har et stort fordelingsvolumen på 25,8 l og er ca. 50 % bundet til plasmaproteiner.
English: Most patients had received prior doxorubicin or equivalent at dose of up to 450 mg/m².
Danish: De fleste patienter havde fået forudgående doxorubicin eller tilsvarende i doser på op til 450 mg/m2.
English: As metabolism appears to be limited, biliary excretion of unchanged pixantrone may be the major elimination pathway.
Danish: Da metaboliseringen synes at være begrænset, kan biliær udskillelse af uændret pixantron være den vigtigste eliminationsvej.
English: The incidence of severe infections was low and opportunistic infections associated with immunocompromise were not seen.
Danish: Forekomsten af svære infektioner var lav, og der forekom ikke opportunistiske infektioner betinget af immunsuppression.
English: In particular, make sure to tell your doctor if you are currently using, or have recently used, any of the following medicines:
Danish: Fortæl det især til lægen, hvis du bruger eller for nylig har brugt nogle af følgende lægemidler:
English: After transferring, thoroughly mix the contents of the infusion bag.
Danish: Efter overførsel blandes indholdet af infusionsposen omhyggeligt.
English: Your doctor will carry out some tests before you are given Pixuvri.
Danish: Lægen vil foretage nogle test, før du får Pixuvri.
English: Warnings and precautions Talk to your doctor before using Pixuvri:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du bruger Pixuvri:
English: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton, Lancashire BL5 3XX United Kingdom
Danish: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton, Lancashire BL5 3XX Storbritannien
English: This applies to women who can become pregnant and men receiving Pixuvri who may be able to father a child.
Danish: Dette gælder kvinder, der kan blive gravide, og fertile mænd, der får Pixuvri.
English: Prevention of photosensitivity reactions
Danish: Forebyggelse af lysoverfølsomhedsreaktioner
English: Pixuvri with food and drink You do not have to change your diet after treatment with Pixuvri unless instructed by your doctor.
Danish: Brug af Pixuvri sammen med mad og drikke Du behøver ikke at ændre kost efter behandlingen med Pixuvri, medmindre lægen har sagt det til dig.
English: Date of latest renewal: 06 June 2019
Danish: Dato for første markedsføringstilladelse: 10. maj 2012 Dato for seneste fornyelse: 06. juni 2019
English: Uncommon Hypersensitivity to the medicinal product
Danish: Ikke almindelig Overfølsomhed for lægemidlet
English: The final concentration of pixantrone in the infusion bag should be less than 580 microgram /ml based upon input of reconstituted medicinal product.
Danish: Den endelige koncentration af pixantron i infusionsposen skal være mindre end 580 µg/ml, baseret på den tilsatte mængde rekonstitueret lægemiddel.
English: The mixture should be a clear and dark blue solution.
Danish: Blandingen skal være en klar, mørkeblå opløsning.
English: In repeated-dose studies in mice, rats, and dogs, the main findings were myelotoxicity, nephrotoxicity (except dogs), and testicular damage.
Danish: Ved studier med gentagne doser hos mus, rotter og hunde var de vigtigste fund myelotoksicitet, nefrotoksicitet (bortset fra hunde) og testikelbeskadigelse.
English: Minimal cardiotoxicity of Pixuvri was also demonstrated with repeat treatment cycles at the same doses.
Danish: Desuden påvistes der minimal kardiotoksicitet af Pixuvri ved gentagne behandlingscyklusser med samme doser.
English: In vitro studies with the most common human cytochrome P450 isoforms (including CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4) have shown a possible mixed-type inhibition of CYP1A2 and CYP2C8 that may be of clinical relevance.
Danish: In vitro-studier med de almindeligste humane CYP P450-isoformer (herunder CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 og 3A4) har vist hæmning af CYP1A2 og CYP2C8, muligvis af blandet type, som kan være klinisk relevant.
English: In human urine, the compound was mainly excreted unchanged, and very small amounts of phase I and phase II acetylated metabolites were found.
Danish: I human urin blev stoffet hovedsagelig udskilt i uændret form, og der fandtes kun meget små mængder metabolitter acetyleret i fase I og fase II.
English: In the EU recommended dose refers to the base of the active substance (pixantrone).
Danish: I EU henviser den anbefalede dosis til det aktive stofs (pixantron) basisstoffet.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: Handle with caution.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk: Bør omgås med forsigtighed.
English: Patients with neutropenia are more susceptible to infections, although, in the clinical studies there was no increased incidence of atypical, difficult-to-treat infections, such as systemic mycotic infections or infections with opportunistic organisms such as Pneumocystis jiroveci.
Danish: Patienter med neutropeni er mere modtagelige for infektioner, skønt der i de kliniske studier ikke var forhøjet forekomst af atypiske, vanskeligt behandlelige infektioner som systemiske mykoser eller infektioner med opportunistiske organismer som Pneumocystis jiroveci.
English: Pixantrone dimaleate up to 27 mg/kg given twice a week for 4 weeks did not induce any cardiotoxic effects, while mitoxantrone, as expected, was cardiotoxic at all tested doses (0.6, 1.6, and 1.5 mg/kg).
Danish: Pixantrondimaleat, op til 27 mg/kg to gange ugentligt i fire uger, forårsagede ingen kardiotoksiske virkninger, hvorimod mitoxantron som forventet var kardiotoksisk ved alle testede doser (0,6, 1,6 og 1,5 mg/kg).
English: Pixuvri must not be used with other medicines unless your doctor has told you it is safe to do so.
Danish: Brug ikke Pixuvri sammen med andre lægemidler, medmindre lægen har fortalt dig, at du kan gøre det uden risiko.
English: Secondary malignancy
Danish: Sekundær malignitet
English: It is not known whether Pixuvri has an effect on the ability to drive a car or use machines.
Danish: Det vides ikke, om Pixuvri påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: Kidney function and histology were similarly not affected both in 4- and 26-week studies.
Danish: Tilsvarende var der ingen påvirkning af nyrernes funktion eller histologi i 4-ugers eller 26 ugers-studierne.
English: Infections have been associated with hospitalisation, septic shock, and death.
Danish: Infektionerne har været forbundet med indlæggelse, septisk shock og mors.
English: Although a risk to inhibition of pixantrone towards CYP2C8 could not be ascertained, caution should be observed when co-administering substances that are primarily metabolised via CYP2C8, such as repaglinide, rosiglitazone, or paclitaxel e.g. by careful monitoring for side effects.
Danish: Skønt det ikke har været muligt at bekræfte risikoen for, at pixantron hæmmer CYP2C8, bør der udvises forsigtighed ved koadministration af midler, der primært metaboliseres via CYP2C8, såsom repaglinid, rosiglitazon og paclitaxel, f.eks. ved nøje overvågning for bivirkninger.
English: If you will be exposed to sunlight, you should wear sunprotective clothing and use sunscreen that strongly absorbs UV-A.
Danish: Hvis du bliver udsat for sollys, bør du bære tøj, der beskytter mod sollys og bruge solcreme med høj beskyttelsesfaktor mod UV-A.
English: For the study overall, patient median age was 59, 61% were male, 64% were Caucasian, 76% had Ann Arbor stage III/IV disease at baseline, 74% had a baseline
Danish: For studiet som helhed var patienternes mediane alder 59 år, 61 % var mænd, 64 % var af kaukasisk race, 76 % havde sygdom i Ann Arbor stadium III/IV ved baseline, 74 % havde en International Prognostic Index (IPI) score ved baseline på ≥ 2, og 60 % havde fået ≥ 3 foregående kemoterapeutiske behandlinger.
English: Mantle cell lymphoma patients were not included in the pivotal study.
Danish: Patienter med mantlecellelymfom blev ikke inkluderet i det pivotale studie.
English: Embryotoxicity was characterised by reduced mean foetal weight, foetal malformations and incomplete or delayed foetal ossification.
Danish: Embryotoksiciteten var karakteriseret af nedsat gennemsnitsvægt for fosteret, føtale misdannelser og ufuldstændig eller forsinket føtal ossifikation.
English: For subsequent courses, the prior dose can usually be repeated if white blood cell and platelet counts have returned to acceptable levels.
Danish: Ved de efterfølgende behandlingsforløb kan den foregående dosis sædvanligvis gentages, hvis leukocyt- og trombocyttal er restitueret til acceptable niveauer.
English: Pixantrone did inhibit OCT1-mediated metformin transport in vitro, but is not expected to inhibit OTC1 in vivo at clinically relevant concentrations.
Danish: Pixantron hæmmede OCT1-medieret transport af metformin in vitro, men forventes ikke at hæmme OTC1 in vivo ved klinisk relevante koncentrationer.