FrancophonIA/ELRC3.0 huggingface dataset:
English: Pixantrone has a moderate to high total plasma clearance of 72.7 l/hr and a low renal excretion accounting for less than 10% of the administered dose in 0-24 hours.
Danish: Pixantron har en moderat til høj plasmaclearance på 72,7 l/t og en lav renal udskillelse, der tegner sig for mindre end 10 % af den administrerede dosis i løbet af 0-24 timer.
English: Although the incidence of severe marrow suppression with clinical consequences is relatively low, patients have been treated with Pixuvri were closely monitored by frequent blood counts, particularly for neutropenia.
Danish: Skønt forekomsten af svær knoglemarvssuppression med kliniske følger er forholdsvis lav, er patienter i behandling med Pixuvri blevet tæt overvåget ved hyppig bestemmelse af blodbilledet, navnlig med henblik på neutropeni.
English: Photosensitivity is a potential risk based on in vitro and in vivo non-clinical data.
Danish: Lysoverfølsomhed er en potentiel risiko baseret på ikke-kliniske in vitro- og in vivo-data.
English: Due to this unique structure, pixantrone produced minimal cardiotoxicity in animal models compared with doxorubicin or mitoxantrone.
Danish: Som følge af denne unikke struktur bevirkede pixantron minimal kardiotoksicitet i dyremodeller i forhold til doxorubicin og mitoxantron.
English: In 11 Pixuvri-treated patients, these events were grade 1-2 and in 2 patients they were grade 3; these events were transient and not Pixuvri dose related.
Danish: Hos 11 patienter behandlet med Pixuvri var disse hændelser af grad 1-2, og hos 2 patienter var de af grad 3; hændelserne var forbigående og uden sammenhæng med dosis af Pixuvri.
English: With the recommended dose and schedule, neutropenia is usually transient, reaching its nadir on days 15-22 following administration on days 1, 8, and 15 with recovery usually occurring by day 28.
Danish: Ved den anbefalede dosering og doseringsplan er neutropeni sædvanligvis forbigående med lavpunkt på dag 15-22 efter administration på dag 1, 8 og 15, og med restitution sædvanligvis indtrædende inden dag 28.
English: Table 1 and Table 2 are recommended as guides to dosage adjustments for days 8 and 15 of the 28- day cycles.
Danish: Det anbefales at følge tabel 1 og tabel 2 som retningslinje for dosisjusteringer på dag 8 og 15 af 28-dages cyklusserne.
English: Infections, including pneumonia, cellulitis, bronchitis, and sepsis have been reported during clinical trials (see section 4.8).
Danish: Infektioner, herunder pneumoni, cellulitis, bronkitis og sepsis, er indberettet i de kliniske studier (se pkt.
English: Single doses of pixantrone up to 158 mg/m2 have been given in dose-escalation clinical trials without evidence of dose-related toxicity.
Danish: Der er blevet administreret enkeltdoser af pixantron op til 158 mg/m2 i kliniske dosiseskaleringsstudier uden tegn på dosisrelateret toksicitet.
English: Skin discolouration and chromaturia are known related effects of Pixuvri administration due to the colour of the compound (blue).
Danish: Ændret hudfarve og kromaturi er kendte virkninger af administration af Pixuvri på grund af stoffets farve (blå).
English: In the study PIX 301, decreased ejection fraction occurred in 13 patients (19.1%) in the Pixuvri group.
Danish: I studie PIX 301 forekom der nedsat uddrivningsfraktion hos 13 patienter (19,1 %) i gruppen behandlet med Pixuvri.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pixuvri in all subsets of the paediatric population in treatment of non-Hodgkin lymphoma.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Pixuvri i alle undergrupper af den pædiatriske population ved behandling af non-Hodgkins lymfom (se pkt.
English: If Pixuvri (lyophilised powder or reconstituted liquid solution) contacts the skin, wash the skin immediately and flush the membranes thoroughly with water.
Danish: Hvis Pixuvri (det frysetørrede pulver eller den rekonstituerede opløsning) kommer i kontakt med huden, skal det straks afvaskes, og membranerne skylles grundigt med vand.
English: Patients treated with Pixuvri showed a significantly higher rate of complete responses and unconfirmed complete responses (CR/CRu), and a higher objective response rate (ORR), compared to the comparator group (see Table 4).
Danish: Patienter behandlet med Pixuvri viste signifikant højere rate af komplet respons og ubekræftet komplet respons (CR/CRu) og højere rate af objektivt respons (ORR) end behandlingerne i komparatorgruppen (se tabel 4).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet i efter faldende sværhedsgrad.
English: However, in vitro, conversion of pixantrone into the acetylated metabolites by either NAT1 or NAT2 was very limited.
Danish: In vitro omdannedes pixantron imidlertid kun i meget begrænset omfang til acetylerede metabolitter af NAT1 eller NAT2.
English: Women and men must use effective contraception during and up to 6 months after treatment.
Danish: Kvinder og mænd skal anvende sikker kontraception under behandlingen og i seks måneder efter behandlingen.
English: Tell your doctor if you get any symptoms of an infection (for example, fever, chills, trouble breathing, cough, sores in your mouth, trouble swallowing, or severe diarrhoea) after Pixuvri treatment.
Danish: Sig det til lægen, hvis du får symptomer på en infektion (f.eks. feber, kulderystelser, vejrtrækningsbesvær, hoste, mundsår, synkebesvær eller svær diarré) efter behandling med Pixuvri.
English: Pixuvri was mutagenic in the Ames test, increased the number of chromosomal aberrations in human lymphocytes, and increased the frequency of micronuclei in vivo.
Danish: Pixuvri var mutagent i Ames test, øgede antallet af kromosomaberrationer i humane lymfocytter og øgede mikronukleus-frekvensen in vivo.
English: Coagulation parameters, specifically international normalised ratio (INR), should be monitored in the days immediately following the initiation of Pixuvri concurrent therapy.
Danish: Koagulationsparametre, nærmere bestemt den internationale normaliserede ratio (INR), bør overvåges i dagene umiddelbart efter initiering af samtidig behandling med Pixuvri.
English: Hematologic toxicities and complications of neutropenia Hematologic toxicities have been the most frequent toxicity observed but they have, in general, been easily managed with granulocyte-colony stimulating factor (G-CSF) and transfusion support as needed.
Danish: Hæmatotoksiske toksiske virkningerr og komplikationer ved neutropeni Hæmatotoksicitet har været den oftest iagttagne toksiske virkning, men har sædvanligvis været let behandlelig med granulocyt-kolonistimulerende faktor (G-CFS) og støttende transfusion efter behov.
English: Equipment such as vials, needles and syringes used for Pixuvri administration should be handled as toxic waste.
Danish: Udstyr som hætteglas, kanyler og sprøjter, der er anvendt til administration af Pixuvri, bør håndteres som giftigt affald.
English: In dogs, tachycardia and electrocardiography (ECG) changes occurred immediately after treatment.
Danish: Hos hunde opstod der takykardi og EKG-ændringer umiddelbart efter behandlingen.
English: Since most medicinal product-induced photosensitivity reactions are caused by wavelengths within the UV-A range, sunscreen that strongly absorbs UV-A is recommended.
Danish: Da de fleste lægemiddelinducerede lysfølsomhedsreaktioner forårsages af bølgelængder i UVA-området, anbefales solcreme, der effektivt absorberer UVA.
English: There is limited data in patients previously treated with rituximab (38 patients in the Pixuvri arm and 39 patients in the comparator arm).
Danish: For patienter, der tidligere havde været behandlet med rituximab, foreligger der kun begrænsede data (38 patienter i Pixuvri-armen og 39 patienter i standardarmen).
English: Progression Free Survival Probability
Danish: Sandsynlighed for progressionsfri overlevelse
English: Pixuvri kills cancer cells by binding to DNA, resulting in cell death.
Danish: Pixuvri dræber kræftceller ved at binde sig til DNA, så cellerne dør.
English: Pixuvri belongs to a pharmacotherapeutic group of medicines known as ‘antineoplastic agents'.
Danish: Pixuvri tilhører en gruppe lægemidler, som kaldes antineoplastiske midler.
English: Skin and subcutaneous tissue disorders*
Danish: Hud og subkutane væv*
English: The mixture should be a dark blue solution.
Danish: Blandingen skal være en mørkeblå opløsning.
English: There is a possibility that your heart pumping function could decrease as a result of the treatment or you might even develop a serious condition called heart failure, especially if your heart function was already compromised at the beginning of the treatment with Pixuvri.
Danish: Dit hjertes pumpekapacitet vil muligvis blive mindre på grund af behandlingen, eller måske vil du endda kunne udvikle svær hjerteinsufficiens, navnlig hvis din hjertefunktion i forvejen var nedsat, da du blev sat i behandling med Pixuvri.
English: A comprehensive retrospective population PK/PD analysis of Phase 1 trials and combination regimens (Phase 1/2) demonstrated that progression-free survival and Grade 2-3 neutropenia were related to Pixuvri exposure.
Danish: En omfattende retrospektiv farmakokinetisk og farmakodynamisk populationsanalyse af fase 1-studier og af kombinationsregimer (fase 1/2) viste, at progressionsfri overlevelse og neutropeni af grad 2-3 havde sammenhæng med eksponering for Pixuvri.
English: Pixuvri must be administered by physicians who are familiar with the use of antineoplastic agents and have the facilities for regular monitoring of clinical, haematological, and biochemical parameters during and after treatment (see section 6.6).
Danish: Pixuvri skal administreres af læger, der er fortrolige med anvendelse af antineoplastiske midler og råder over faciliteter til regelmæssig overvågning af kliniske, hæmatologiske og biokemiske parametre under og efter behandlingen (se pkt.
English: Pixuvri caused maternal and foetal toxicity in rats and rabbits, even at a dose as low as 1.8 mg/kg given on days 9-11 of pregnancy, higher doses resulting in abortions and total embryo resorption.
Danish: Pixuvri medførte maternel og føtal toksicitet hos rotter og kaniner selv ved doser ned til 1,8 mg/kg givet på dag 9-11 af drægtighedsperioden, mens højere doser medførte aborter og fuldstændig embryoresorption.
English: In vitro inhibition studies
Danish: In vitro-hæmningsstudier
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 °C til 8 °C).
English: After a single intravenous administration of Pixuvri at 29 mg/kg and 38 mg/kg, immediate deaths were seen in mice (114 mg/m2, LD10).
Danish: En enkelt intravenøs administration af Pixuvri på 29 mg/kg og 38 mg/kg medførte øjeblikkelig død hos mus (114 mg/m2, LD10).
English: In dogs, Pixuvri given at 0.5 to 0.9 mg/kg for six cycles did not cause mortality or severe clinical signs, including ECG or body weight changes.
Danish: Hos hunde medførte Pixuvri i en dosis på 0,5-0,9 mg/kg i seks cyklusser ingen dødelighed eller svære kliniske symptomer, herunder EKG- eller kropsvægtforandringer.
English: The terminal half-life ranged from 14.5 to 44.8 hr with a mean of 23.3 ± 8.0 (n=14, CV=34%) and a median of 21.2 hr. Due to the limited contribution of renal clearance, plasma clearance is mainly non-renal.
Danish: Den terminale halveringstid lå fra 14,5-44,8 t med et gennemsnit på 23,3 ± 8,0 (n=14, en variationskoefficient (CV) = 34 %) og en medianværdi på 21,2 t. Den renale clearance er begrænset, hvorfor plasmaclearance hovedsagelig er ikke-renal.
English: Hepatic clearance approximates the hepatic plasma flow, suggesting a high hepatic extraction ratio and, therefore, efficient parent active substance elimination.
Danish: Den hepatiske clearance svarer omtrent til det hepatiske plasmaflow, hvilket tyder på et højt hepatisk ekstraktionsforhold og dermed en effektiv elimination af moderstoffet.
English: The occurrence of secondary cancers, including AML and MDS, may occur during or after treatment with Pixuvri.
Danish: Forekomsten af sekundære kræftformer, inklusive AML og MDS, kan ske under eller efter behandling med Pixuvri.
English: Genotoxicity studies confirmed the potential for clastogenic effects in mammalian cells in vitro and in vivo.
Danish: Genotoksicitetsstudierne bekræftede potentialet for klastogene virkninger i pattedyrceller in vitro og in vivo.
English: Males showed, however, slightly higher exposure than females.
Danish: Hos handyr var eksponeringen imidlertid lidt højere end hos hundyr.
English: This study randomised 140 patients (1:1) to treatment with either Pixuvri or to an investigator chosen single-agent chemotherapy on the comparator arm.
Danish: I dette studie randomiseredes 140 patienter (1:1) til behandling enten med Pixuvri eller med en af studielederen valgt kemoterapeutisk monoterapi.
English: Adequate contraceptive precautions must be used when receiving Pixuvri and for up to 6 months after treatment.
Danish: Der skal bruges sikker prævention under behandlingen med Pixuvri og indtil seks måneder efter behandlingen.
English: The non-vesicant properties of Pixuvri minimise the risk of local reaction following extravasation.
Danish: Pixuvri er ikke udpræget vævstoksisk, hvilket minimerer risikoen for lokalreaktion efter ekstravasation.
English: Immunisation with live virus vaccines is contraindicated due to the immunosuppression associated with Pixuvri therapy (see section 4.3).
Danish: Vaccination med levende virus er kontraindiceret på grund af den immunsuppression, der er forbundet med behandling med Pixuvri (se pkt.
English: The safety and efficacy of Pixuvri in children aged < 18 years has not yet been established.
Danish: Pixuvris sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Calculation of the individual dose to be administered to a patient must be based on the strength of the reconstituted solution that contains 5.8mg/ml pixantrone and the dose recommendation of 50 mg/m2.
Danish: Beregning af den individuelle dosis, der skal administreres til en patient, skal baseres på styrken af den rekonstituerede opløsning, som indeholder 5,8 mg/ml pixantron, og dosisanbefalingen på 50 mg/m2.
English: Pixuvri Dose (mg/m2) Number of patients
Danish: Dosis af Pixuvri (mg/m2)
English: This yields a dark blue solution with a pixantrone concentration of 5.8 mg/ml.
Danish: Herved fremkommer en mørkeblå opløsning med en koncentration af pixantron på 5,8 mg/ml.
English: Any grade 3 or 4 drug-related non cardiac toxicity other than nausea or vomiting
Danish: Enhver lægemiddelrelateret, ikke-kardiel toksicitet af grad 3 eller 4 bortset fra kvalme og opkastning
English: Any grade 3 or 4 NYHA* cardiovascular toxicity or persistent LVEF** decline
Danish: Enhver kardiovaskulær toksicitet af NYHA* grad 3 eller 4, eller persisterende fald i LVEF**
English: Upon reconstitution and dilution, this medicinal product contains approximately 1g (43 mmol) sodium per dose, equivalent to 50% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Efter rekonstitution og fortynding indeholder dette lægemiddel cirka 1 g (43 mmol) natrium pr. dosis, svarende til 50 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: In addition, caution should be taken when pixantrone is continuously co-administered with efflux transport inducers such as rifampicin, carbamazepin and glucocorticoids, as pixantrone excretion might be increased with a consequent decrease of systemic exposure.
Danish: Der bør desuden udvises forsigtighed ved kontinuerlig koadministration af pixantron med effluxinducerende stoffer som rifampicin, carbamazepin og glukokortikoider, da udskillelsen af pixantron kan tænkes at øges med deraf følgende mindskelse af den systemiske eksponering.
English: Event (death) Median OS (95% CI)
Danish: Antal hændelser (død) Median samlet overlevelse (95 % SI)
English: Figure 2 PIX 301 Overall survival-end of study
Danish: Figur 2 Samlet overlevelse i PIX 301 ved studiets slutning
English: Pixuvri may be metabolised in the liver and/or excreted in the bile.
Danish: Pixuvri kan metaboliseres i leveren og/eller udskilles i galden.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Cardiac function should be monitored before initiation and during the treatment with Pixuvri .
Danish: Hjertefunktionen bør overvåges før initiering og under behandlingen med Pixuvri.
English: Figure 1 PIX301 Progression-free survival - end of study
Danish: Figur 1 Progressionsfri overlevelse i PIX301 ved studiets slutning
English: Cardiac failure events (MedDRA terms cardiac failure, cardiac failure acute and cardiac failure congestive) occurred in 6 patients (8.8%) treated with Pixuvri (2 patients with grade 1-2, 1 patient with grade 3, and 3 patients, 2 considered as unrelated, with grade 5).
Danish: Hændelser i form af hjerteinsufficiens (MedDRA-betegnelserne hjerteinsufficiens, akut hjerteinsufficiens og kongestiv hjerteinsufficiens) forekom hos 6 patienter (8,8 %), der blev behandlet med Pixuvri (2 patienter med grad 1-2, 1 patient med grad 3, og 3 patienter, hvoraf 2 blev vurderet som urelaterede, med grad 5).
English: As a precaution, patients should be advised to follow sun protection strategies, including wearing sun protective clothing and using sunscreen.
Danish: Som sikkerhedsforanstaltning bør patienterne instrueres i at beskytte sig mod solen med beskyttende tøj og solcreme.
English: Uncommon Spontaneous penile erection
Danish: Ikke almindelig Spontan erektion
English: Other toxicities such as nausea, vomiting, and diarrhoea were generally infrequent, mild, reversible, manageable, and expected in patients treated with cytotoxic agents.
Danish: Andre toksiske virkninger som kvalme, opkastning og diarré var sædvanligvis ikke hyppige, var lette, reversible og kontrollerbare og svarede til det forventelige hos patienter i behandling med cytotoksiske stoffer.
English: P-value
Danish: P- værdi
English: Pain/redness of the injection site may occur rarely during infusion of Pixuvri.
Danish: Smerte og rødme på injektionsstedet optræder i sjældne tilfælde under infusion af Pixuvri.
English: One case of photosensitivity reaction has been reported in the clinical trial program considered as non-serious and with outcome recovered.
Danish: Der er blevet indberettet et tilfælde af lysoverfølsomhedsreaktion i det kliniske studieprogram, dette tilfælde blev vurderet som ikke-alvorligt og patienten kom sig efterfølgende.
English: Furthermore, because it incorporates a nitrogen heteroatom into the ring structure and does not have ketone groups, pixantrone has less potential for generating reactive oxygen species, binding iron, and forming alcohol metabolites that are felt to cause the cardiac toxicity of anthracyclines.
Danish: Da pixantron indeholder et nitrogenheteroatom i ringen og er uden ketongruppe, har det desuden mindre potentiale for dannelse af reaktive oxygenforbindelser, binding af jern og dannelse af de alkoholmetabolitter, der formodes at være årsag til kardiotoksiciteten af antracycliner.
English: The amounts (dose) of Pixuvri that will be given to you will depend on your body surface area in square meters (m2).
Danish: Den mængde (dosis), du vil få, afhænger af din legemsoverflade i kvadratmeter (m2).
English: The development of haematological malignancies such as secondary acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) is a recognised risk associated with anthracycline treatment and other topoisomerase II inhibitors.
Danish: Udviklingen af blodkræftssygdomme, såsom sekundær akut myeloid leukæmi (AML) eller myelodysplastisk syndrom (MDS) er en erkendt risiko forbundet med antracyklinbehandling og andre topoisomerase II-hæmmere.
English: After repeated administrations of Pixuvri at doses as low as 0,1 mg/kg/day, a dose-dependent testicular atrophy was detected in the dogs.
Danish: Ved gentagen administration af Pixuvri i doser ned til 0,1 mg/kg/dag sås dosisafhængig testikelatrofi hos hunde.
English: Pixuvri should not be administered to patients with an active, severe infection or in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose them to serious infection.
Danish: Pixuvri bør ikke anvendes til patienter med aktiv svær infektion, tilbagevendende eller kroniske infektioner i anamnesen eller underliggende sygdom, der kan disponere for alvorlige infektioner.
English: Changes in cardiac function including decreased LVEF or fatal congestive heart failure (CHF) may occur during or after treatment with Pixuvri.
Danish: Ændringer i hjertefunktionen, herunder nedsat LVEF eller fatal kongestiv hjerteinsufficiens (CHF) kan optræde under eller efter behandling med Pixuvri.
English: Devices and surfaces accidentally contaminated with Pixuvri must be treated with a solution of sodium hypochlorite (100 µl of water and 20 µl of sodium hypochlorite [7 ± 2% of available chlorine] for 0.58 mg of Pixuvri).
Danish: Udstyret og overflader, der utilsigtet er kontamineret med Pixuvri, skal behandles med en opløsning af natriumhypochlorit (100 µl vand og 20 µl natriumhypochlorit [7 ± 2 % frit chlor] til 0,58 mg Pixuvri).
English: The skin discolouration generally disappears over a few days to weeks as the medicinal product is cleared.
Danish: Farveforandringen af huden svinder sædvanligvis i løbet af nogle dage, efterhånden som lægemidlet elimineres.
English: Mechanism of action The active substance of Pixuvri is pixantrone , a cytotoxic aza-anthracenedione.
Danish: Virkningsmekanisme Det aktive stof i Pixuvri, pixantron, er et cytotoksisk aza-antracendion.
English: Repeated MUGA scan or ECHO determinations of LVEF should be considered in patients with risk factors such as high cumulative exposure to prior anthracyclines or significant pre-existing cardiac disease.
Danish: Gentagne bestemmelser af LVEF ved MUGAskanning eller ekkokardiografi bør overvejes hos patienter med risikofaktorer såsom tidligere høj kumulativ eksponering for antracycliner eller præeksisterende kardiel sygdom af væsentligt omfang.
English: The most common toxicity is bone marrow suppression, particularly of the neutrophil lineage.
Danish: Den oftest forekommende toksiske virkning er knoglemarvssuppression, navnlig for celler af neutrofil oprindelse.
English: A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity.
Danish: Der anbefales kardiel udredning ved baseline med MUGA-skanning eller ekkokardiografi, navnlig hos patienter med risikofaktorer for øget kardiotoksicitet.
English: Neoplasm progression
Danish: Progression af neoplasmer
English: The cardiotoxic potential of Pixuvri compared with equiactive doses of doxorubicin and mitoxantrone in treatment-naïve and doxorubicin-pre-treated mice was evaluated.
Danish: Det kardiotoksiske potentiale af Pixuvri blev vurderet i forhold til ækvivalente doser af doxorubicin og mitoxantron hos behandlingsnaive og doxorubicin-forbehandlede mus.
English: Three Pixuvri patients (4.4%) had tachycardia, arrhythmia, sinus tachycardia, supraventricular tachycardia or bradycardia.
Danish: 3 patienter behandlet med Pixuvri (4,4 %) fik takykardi, arytmi, sinustakykardi, supraventrikulær takykardi eller bradykardi.
English: Uncommon: may affect up to 1 in 100 people - severe infections such as septic shock, bronchitis, pneumonia, candidiasis, cellulitis, meningitis,
Danish: Ikke almindelig: kan påvirke op til 1 ud af 100 personer - svære infektioner som septisk shock, bronkitis, lungebetændelse, candidainfektion, cellulitis,
English: The powder should completely dissolve in 60 seconds with agitation.
Danish: Pulveret skal opløses fuldstændigt ved omrystning i 60 sekunder.
English: Lactose monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Danish: Laktosemonohydrat Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering)