FrancophonIA/ELRC3.0 huggingface dataset:
English: The effectiveness and safety of Abraxane in patients with central nervous system (CNS) metastases has not been established.
Danish: Effekten og sikkerheden ved behandling med Abraxane hos patienter med metastaser i centralnervesystemet (CNS) er ikke blevet fastslået.
English: Uncommon: Pneumonitis3
Danish: Ikke almindelig: Pneumonitis3
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: The safety and efficacy of Abraxane in children and adolescents aged 0-17 years has not been established.
Danish: Abraxanes sikkerhed og virkning hos børn og unge i alderen 0-17 år er ikke klarlagt.
English: Abbreviations: ANC=Absolute Neutrophil Count; WBC=white blood cell
Danish: Forkortelser: ANC=Absolut neutrofiltal (ANC=Absolute Neutrophil Count); WBC=hvide blodlegemer
English: P-value (chi-square test)
Danish: P-værdi(chi2 -test)
English: • a medicine called clopidogrel used to prevent blood clots.
Danish: • et lægemiddel, der kaldes clopidogrel og anvendes til at forebygge blodpropper.
English: Abraxane should not be used in combination with other anticancer agents.
Danish: Abraxane bør ikke anvendes sammen med andre kræftlægemidler.
English: There is limited experience of Abraxane/carboplatin use in patients 75 years or older.
Danish: Der er begrænset erfaring med anvendelse af Abraxane/carboplatin hos patienter 75 år og derover.
English: Then, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete resuspension of any powder occurs.
Danish: Derefter bør hætteglasset forsigtigt og langsomt hvirvles og/eller vendes på hovedet i mindst to minutter, indtil alt pulver er helt opløst.
English: The fraction of free paclitaxel was significantly higher with Abraxane (6.2%) than with solvent-based paclitaxel (2.3%).
Danish: Fraktionen af frit paclitaxel var signifikant højere med Abraxane (6,2 %) end med solvensbaseret paclitaxel (2,3 %).
English: Do not administer the reconstituted suspension if particulate matter is observed in the vial.
Danish: Administrer ikke den rekonstituerede suspension, hvis der ses partikler i hætteglasset.
English: This resulted in significantly higher exposure to unbound paclitaxel with Abraxane compared with solvent-based paclitaxel, even though the total exposure is comparable.
Danish: Dette medførte signifikant højere eksponering for ubundet paclitaxel med Abraxane sammenlignet med solvensbaseret paclitaxel, selvom den totale eksponering er sammenlignelig.
English: Patients weighing 50 kg had paclitaxel AUC approximately 25% lower than those weighing 75 kg.
Danish: Patienter, der vejer 50 kg havde en paclitaxel-AUC, der var ca. 25 % lavere end for patienter, der vejede 75 kg.
English: fluoxetine)
Danish: fluoxetin)
English: OR < 50,000
Danish: ELLER < 50.000
English: Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume Abraxane at a reduced dose.
Danish: Ud af de patienter, der fik behandlingen afbrudt på grund af perifer neuropati, var 44% (31/70 patienter) i stand til at genoptage Abraxane med en reduceret dosis.
English: Progression-free Survivala (independent review)
Danish: Progressionsfri overlevelsea (uafhængig gennemgang)
English: If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.
Danish: Hvis der er synligt bundfald eller bundfældning, skal hætteglasset forsigtigt vendes på hovedet igen for at sikre fuldstændig resuspension før brug.
English: Abraxane may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery.
Danish: Abraxane kan muligvis forårsage bivirkninger såsom træthed (meget almindeligt) og svimmelhed (almindeligt), der kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: How often will you receive Abraxane?
Danish: Hvor tit skal jeg have Abraxane?
English: Following Abraxane administration to patients with solid tumours, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%).
Danish: Efter administration af Abraxane til patienter med solide tumorer fordeles paclitaxel ligeligt i blodceller og plasma, og det er bundet til plasmaproteiner i høj grad (94 %).
English: Warnings and precautions Talk to your doctor or nurse before using Abraxane
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du bruger Abraxane
English: Overall Response Rate Confirmed complete or partial overall response, n (%)
Danish: Bekræftet fuldstændigt eller delvist samlet respons, n (%)
English: 2 As reported in the post-marketing surveillance of Abraxane.
Danish: 2 Indberettet i forbindelse med overvågning efter markedsføring af Abraxane.
English: Anemia and thrombocytopenia were more commonly reported in the Abraxane arm than in the Taxol arm (54% versus 28% and 45% versus 27% respectively).
Danish: Anæmi og trombocytopeni blev hyppigere reporteret i Abraxane-armen end i Taxol-armen (hhv. 54 % versus 28 % og 45 % versus 27 %).
English: A higher median cumulative dose of gemcitabine was delivered in the Abraxane/gemcitabine arm (11400 mg/m2) when compared with the gemcitabine arm (9000 mg/m2).
Danish: En højere median kumulativ dosis af gemcitabin blev givet i Abraxane/gemcitabin-armen (11.400 mg/m2) sammenlignet med gemcitabin-armen (9.000 mg/m2).
English: In the comparator treatment arm, gemcitabine monotherapy was administered to patients (N = 430) in accordance with the recommended dose and regimen.
Danish: I den sammenlignende behandlingsarm blev gemcitabin monoterapi administreret til patienter (N = 430) i henhold til den anbefalede dosis og regime.
English: The median relative dose intensity of Abraxane was 81%.
Danish: Den mediane relative dosisintensitet for Abraxane var 81%.
English: Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during administration of the medicinal product.
Danish: Da der er risiko for ekstravasation, tilrådes det at overvåge infusionsstedet nøje for mulige infiltrationer under administrationen af lægemidlet.
English: Pharmacokinetic/pharmacodynamic modeling indicates that there is no correlation between hepatic function (as indicated by the baseline albumin or total bilirubin level) and neutropenia after adjusting for Abraxane exposure.
Danish: Farmakokinetiske/farmakodynamiske modeller indikerer, at der ikke er nogen korrelation mellem leverfunktion (indikeret ved niveauet af baseline-albumin eller totalbilirubin) og neutropeni efter justering for Abraxane-eksponering.
English: Grade 3-4
Danish: Grad 3-4
English: • if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm3 - your doctor will advise you on this).
Danish: • hvis du har et nedsat antal hvide blodlegemer (neutrofiltal ved baseline<1.500 celler/mm3- din læge kan fortælle dig om dette).
English: Reconstitution of 250 mg:
Danish: Rekonstitution af 250 mg:
English: Abraxane should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
Danish: Abraxane bør ikke anvendes under graviditeten eller til fertile kvinder, der ikke anvender sikker kontraception, medmindre moderens kliniske tilstand kræver behandling med paclitaxel.
English: On the basis of the scientific conclusions for paclitaxel albumin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing paclitaxel albumin is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for paclitaxel albumin er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder paclitaxel albumin, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Pregnant staff should not handle Abraxane.
Danish: Gravide kvinder bør ikke håndtere Abraxane.
English: What Abraxane is used for Abraxane is used to treat the following types of cancer:
Danish: Anvendelse Abraxane anvendes til behandling af de følgende kræfttyper:
English: The key secondary endpoints were progressionfree survival (PFS) and overall response rate (ORR), both assessed by independent, central, blinded radiological review using RECIST guidelines (Version 1.0).
Danish: De vigtigste sekundære endepunkter var progressionsfri overlevelse (progression-free survival, PFS) og samlet responsrate (overall response rate, ORR), begge vurderet ved en uafhængig, central, blindet radiologisk gennemgang ved at bruge retningslinjer fra RECIST (version 1.0).
English: The median time to improvement by at least 1 grade was 21 days, and the median time to improvement from Grade 3 peripheral neuropathy to Grade 0 or 1 was 29 days.
Danish: Mediantiden til stigning med mindst 1 grad var 21 dage, og mediantiden til stigning fra grad 3 perifer neuropati til grad 0 eller 1 var 29 dage.
English: 1On Day 1 of the 21-day cycle reduce the dose of Abraxane and carboplatin simultaneously.
Danish: 1På Dag 1 i 21-dages cyklussen reduceres dosis af Abraxane og carboplatin på samme tid.
English: Abraxane is supplied as a sterile lyophilised powder for reconstitution before use.
Danish: Abraxane leveres som et sterilt, frysetørret pulver til rekonstitution inden brug.
English: Rare: Pancytopenia
Danish: Sjælden: Pancytopeni
English: • medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic),
Danish: • medicin til behandling af infektioner (dvs. antibiotika som erythromycin, rifampicin osv. Spørg din læge, sundhedspersonalet eller apotekspersonalet, hvis du ikke er sikker på, om den medicin,
English: Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with Abraxane.
Danish: Grad 4 neutropeni (<500 celler/mm3) forekom hos 9 % af de patienter, der blev behandlet med Abraxane.
English: In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving Abraxane.
Danish: Generelt var hyppigheden og sværhedsgraden af neurotoksicitet dosisafhængig hos patienter, der fik Abraxane.
English: Two hundred and twenty nine patients treated with Abraxane in the randomized, controlled clinical trial were evaluated for safety.
Danish: 229 patienter, der blev behandlet med Abraxane i det randomiserede, kontrollerede kliniske studier, blev evalueret med hensyn til sikkerhed.
English: Very common: Anorexia
Danish: Meget almindelig: Anoreksi
English: Very common: Dyspnoea
Danish: Meget almindelig: Dyspnø
English: Delay doses until recovery
Danish: Udsæt dosis indtil bedring
English: Fifty-nine percent received study medicinal product as second or greater than second-line therapy.
Danish: 59 % fik studiemedicinen som anden linje behandling eller senere behandling.
English: It may harm them, even if their signs of illness are the same as yours.
Danish: 16,1 [15,0; 18,3] (n = 135)
English: Animal studies with Abraxane showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Danish: Dyrestudier viste irreversible, toksiske virkninger på de mandlige forplantningsorganer ved klinisk relevante eksponeringsniveauer.
English: The median time to disease progression was 5.3 months (175 mg/m2; 95% CI: 4.6-6.2 months) and 6.1 months (300 mg/m2; 95% CI: 4.2-9.8 months).
Danish: Den mediane tid til sygdomsprogression var 5,3 måneder (175 mg/m2; 95 % CI: 4,6 - 6,2 måneder) og 6,1 måneder (300 mg/m2; 95 % CI: 4,2 - 9,8 måneder).
English: Asthenia/Fatigue was reported in 40% of the patients.
Danish: Asteni/træthed blev rapporteret af 40 % af patienterne.
English: Pharmacokinetic interactions between Abraxane and gemcitabine have not been evaluated in humans.
Danish: Farmakokinetiske interaktioner mellem Abraxane og gemcitabin er ikke blevet evalueret hos mennesker.
English: 1 Peripheral neuropathy evaluated using the SMQ (broad scope).
Danish: 1 Perifer neuropati evalueret ved brug af SMQ (bredt defineret).
English: If patients experience nausea, vomiting and diarrhoea following the administration of Abraxane, they may be treated with commonly used anti-emetics and constipating agents.
Danish: Hvis patienterne oplever kvalme, opkastning og diarré efter administration af Abraxane, kan de behandles med de almindeligt anvendte antiemetika og obstiperende midler.
English: For treatment of metastatic breast cancer, Abraxane is usually given once every three weeks (on day 1 of a 21-day cycle).
Danish: Til behandling af metastatisk brystkræft gives Abraxane sædvanligvis én gang hver tredje uge (på dag 1 i en 21-dages cyklus).
English: ABRAXANE+Gemcitabine Gemcitabine
Danish: ABRAXANE+gemcitabin Gemcitabin
English: The response rates in all patients were 39.5% (95% CI: 24.9%-54.2%) and 47.6% (95% CI: 35.3%-60.0%), respectively.
Danish: Responsraterne hos alle patienter var henholdsvis 39,5 % (95 % CI: 24,9 % - 54,2 %) og 47,6 % (95 % Cl: 35,3 % - 60,0 %).
English: Dose adjustments during treatment of breast cancer
Danish: Doseringsjustering under behandlingen af brystkræft
English: Unopened vials of Abraxane are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Danish: Uåbnede hætteglas med Abraxane er stabile indtil den dato, der er angivet på emballagen, så længe hætteglasset opbevares i den ydre karton for at beskytte mod lys.
English: There were no clinically relevant pharmacokinetic interactions between Abraxane and carboplatin.
Danish: Der var ingen klinisk relevante farmakokinetiske interaktioner mellem Abraxane og carboplatin.
English: Limiting the infusion of Abraxane to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.
Danish: Hvis infusionstiden af Abraxane følger anvisningerne og begrænses til 30 minutter, reduceres risikoen for infusionsrelaterede reaktioner.
English: The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Danish: Den rekonstituerede infusionsvæske har en pH-værdi på 6-7,5 og en osmolalitet på 300-360 mOsm/kg.
English: Do not breast feed when taking Abraxane as it is not known if the active ingredient paclitaxel passes into the mother's milk.
Danish: Du må ikke amme, mens du tager Abraxane, da det er ukendt, om det aktive stof paclitaxel udskilles i mælken.
English: Do not use Abraxane
Danish: Brug ikke Abraxane:
English: First Second
Danish: Første Anden
English: Anaemiaa,b Neutropenia a,b Thrombocytopeniab,c a 405 patients assessed in Abraxane/gemcitabine-treated group b 388 patients assessed in gemcitabine-treated group c 404 patients assessed in Abraxane/gemcitabine-treated group
Danish: Anæmia,b Neutropeni a,b Trombocytopenib,c a 405 patienter vurderet i gruppen behandlet med Abraxane/gemcitabin b 388 patienter vurderet i gruppen behandlet med gemcitabin c 404 patienter vurderet i gruppen behandlet med Abraxane/gemcitabin
English: The most common clinically significant adverse reactions associated with the use of Abraxane have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
Danish: De hyppigste klinisk signifikante bivirkninger forbundet med anvendelse af Abraxane har været neutropeni, perifer neuropati, artralgi/myalgi og gastrointestinale symptomer.
English: Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases.
Danish: 64 % af patienterne havde nedsat performance-status (ECOG 1 eller 2) ved indgang i studiet; 79 % havde viscerale metastaser; og 76 % havde >3 metastaselokalisationer.
English: ANNEX IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Danish: BILAG IV Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: Patients in the Abraxane/carboplatin arm had a significantly higher overall response rate compared with patients in the control arm: 33% versus 25%, p = 0.005 (Table 12).
Danish: Patienter i Abraxane/carboplatin-armen havde en signifikant højere samlet responsrate sammenlignet med patienter i kontrolarmen: 33 % versus 25 %, p = 0,005 (Tabel 12).
English: Based on non-compartmental PK analysis, the plasma clearance of paclitaxel with Abraxane was larger (43%) than that following a solvent-based paclitaxel injection and its volume of distribution was also higher (53%).
Danish: Baseret på en non-kompartmental farmakokinetisk analyse var plasmaclearance af paclitaxel med Abraxane større (43 %) end clearance efter en solvensbaseret paclitaxelindsprøjtning, og fordelingsvolumenen var også højere (53 %).
English: However, from a microbiological point of view, unless the method of reconstituting and filling of the infusion bags precludes the risks of microbial contamination, the product should be used immediately after reconstitution and filling of the infusion bags.
Danish: Ud fra et mikrobiologisk synspunkt skal produktet dog anvendes straks efter rekonstitution og fyldning af infusionsposerne, medmindre metoden til rekonstitution og fyldning af infusionsposerne udelukker risiko for mikrobiel kontaminering.
English: Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6-hydroxypaclitaxel; and to two minor metabolites, 3'-p-hydroxypaclitaxel and 6-3'-p-dihydroxypaclitaxel.
Danish: Baseret på den offentliggjorte litteratur viser in vitro-studier med humane levermikrosomer og vævssnit, at paclitaxel primært bliver metaboliseret til 6-hydroxypaclitaxel og til to mindre metabolitter, 3'-p-hydroxypaclitaxel og 6-3'-p-dihydroxypaclitaxel.
English: Taking into account the seriousness of the event, as well as the fact that scleroderma is included in the SmPC of several solvent-based paclitaxel products, the MAH is requested to add scleroderma to section 4.8 of the SmPC with frequency not known.
Danish: I betragtning af hændelsens alvor, samt at sklerodermi er inkluderet i produktresuméet for flere opløsningsmiddelbaserede paclitaxel produkter, bedes MAH tilføje sklerodermi til afsnit 4.8 iproduktresuméet med hyppigheden ikke kendt.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Abraxane should not be substituted for or with other paclitaxel formulations.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Abraxane bør ikke erstatte eller erstattes med andre paclitaxelformuleringer.
English: Gastrointestinal Toxicity: Grade 3 mucositis or diarrhoea
Danish: Gastrointestinal toksicitet: Grad 3 mukosit eller diarré
English: In this phase III randomized, controlled, open-label trial, adverse reactions resulting in death within 30 days of the last dose of study drug were reported for 4% of patients receiving Abraxane in combination with gemcitabine and for 4% of patients receiving gemcitabine monotherapy.
Danish: I dette randomiserede, kontrollerede, åbne fase III-studie, blev bivirkninger, der førte til døden i løbet af 30 dage efter den sidste dosis studiemedicin, rapporteret hos 4% af de patienterne, der fik Abraxane i kombination med gemcitabin, og hos 4% af de patienterne, der fik gemcitabin-monoterapi.
English: There was a statistically significant improvement in OS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates.
Danish: Der var en statistisk signifikant stigning i OS hos patienter, der blev behandlet med Abraxane/gemcitabin versus gemcitabin alene, med 1,8 måneders stigning i median OS, 28% samlet reduktion i risiko for død, 59% forbedring i 1-års overlevelse og 125% forbedring i 2-års overlevelsesrater.
English: Grades 1-4
Danish: Grad 1-4
English: Instructions for use, handling and disposal
Danish: Brugsanvisning, håndtering og bortskaffelse
English: Your doctor will arrange a pregnancy test before starting treatment with Abraxane.
Danish: Din læge vil sørge for en graviditetstest, inden behandlingen med Abraxane påbegyndes.
English: Although limited data is available, no clear benefit in terms of prolonged overall survival has been demonstrated in pancreatic adenocarcinoma patients with normal CA 19-9 levels prior to start of treatment with Abraxane and gemcitabine (see section 5.1).
Danish: Selvom data er begrænsede, er der ikke påvist nogen tydelig fordel med hensyn til langvarig samlet overlevelse hos patienter med adenokarcinom i pancreas med normale CA-19-9-niveauer før behandling med Abraxane og gemcitabin (se pkt.
English: A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Danish: Et randomiseret, åbent multicenterstudie blev udført hos 1.052 kemoterapi-naïve patienter med Stadie IIIb/IV ikke-småcellet lungecancer.
English: Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on Abraxane with 10% being Grade 3, and no cases of Grade 4.
Danish: Perifer neuropati (hovedsagelig grad 1 eller 2 sensorisk neuropati) blev observeret hos 68 % af patienterne, der fik Abraxane; heraf var 10 % grad 3, og ingen var grad 4 (se pkt.
English: ABX/GEM : GEM :
Danish: (PT med risiko) ABX/GEM:
English: Proporti on of
Danish: Pro po rti on of
English: Febrile Neutropenia: Grade 3 or 4
Danish: Febril neutropeni: Grad 3 eller 4
English: For the treated population, the median relative dose intensity for gemcitabine was 75% in the Abraxane/gemcitabine arm and 85% in the gemcitabine arm.
Danish: For den behandlede population var den mediane relative dosisintensitet for gemcitabin 75% i Abraxane/gemcitabin-armen og 85% i gemcitabin-armen.
English: • Abraxane is used in non-small cell lung cancer where surgery or radiotherapy would not be suitable to treat the disease.
Danish: • Abraxane anvendes til ikke-småcellet lungekræft, hvis operation eller strålebehandling ikke er egnet til at behandle sygdommen.
English: Proportion of Survival both study arms treatment was administered until disease progression or development of an unacceptable toxicity.
Danish: I begge studiearme blev behandlingen administreret indtil sygdomsprogression eller udvikling af uacceptabel toksicitet.
English: • Abraxane is also used together with a medicine called carboplatin if you have the most common type of lung cancer, called “non-small cell lung cancer”.
Danish: • Abraxane anvendes sammen med et lægemiddel, der kaldes carboplatin, hvis du har den mest almindelige type lungekræft, der kaldes ”ikke-småcellet lungekræft”.
English: Abraxane is an albumin-bound nanoparticle formulation of paclitaxel, which may have substantially different pharmacological properties compared to other formulations of paclitaxel (see sections 5.1 and 5.2).
Danish: Abraxane er en albuminbundet nanopartikelformulering af paclitaxel, som kan have væsentligt forskellige farmakologiske egenskaber sammenlignet med andre formuleringer af paclitaxel (se pkt.
English: In one study, Abraxane was administered as a 30-minute infusion at a dose of 175 mg/m2 to 43 patients with metastatic breast cancer.
Danish: I ét studie blev Abraxane indgivet som en 30-minutters infusion i en dosis på 175 mg/m2 til 43 patienter med metastaserende brystkræft.