FrancophonIA/ELRC3.0 huggingface dataset:
English: Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane.
Danish: Paclitaxel er et cytotoksisk lægemiddel mod cancer, og som ved andre potentielt toksiske forbindelser, skal der udvises forsigtighed ved håndtering af Abraxane.
English: Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Danish: Abraxane i kombination med carboplatin er indiceret til førstelinjebehandling af ikke-småcellet lungecancer hos voksne patienter, der ikke er kandidater til potentielt kurativ kirurgi og/eller strålebehandling.
English: Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet, and hearing) favored Abraxane and carboplatin (p ≤ 0.002).
Danish: Ved anvendelse af gentagen måleanalyse var 3 ud af de 4 delskalaer (perifer neuropati, smerter i hænder/fødder samt hørelse) bedre for Abraxane og carboplatin (p ≤ 0,002).
English: It is hypothesised that this enhanced transendothelial caveolar transport is mediated by the gp-60 albumin receptor, and that there is enhanced accumulation of paclitaxel in the area of tumour due to the albumin-binding protein Secreted Protein Acidic Rich in Cysteine (SPARC).
Danish: Der er fremsat hypotese om, at denne øgede transendoteliale caveolae-transport formidles af gp-60 albuminreceptoren, og at der er øget akkumulering af paclitaxel i tumorområdet på grund af det albuminbindende protein Secreted Protein
English: The exact total dosing volume of 5 mg/ml suspension required for the patient should be calculated and the appropriate amount of reconstituted Abraxane should be injected into an empty, sterile, PVC or non-PVC type intravenous bag.
Danish: Det nøjagtige, totale volumen af 5 mg/ml infusionsvæsken, der kræves til patienten, beregnes, og den korrekte mængde rekonstitueret Abraxane injiceres i en tom, steril (PVC- eller ikke-PVC-type) infusionspose.
English: However, a subsequent analysis in 981 patients receiving Abraxane monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Danish: En efterfølgende analyse hos 981 patienter, der fik monoterapi med Abraxane for metastatisk brystkræft, hvoraf 15 % var ≥ 65 år, og 2 % var ≥ 75 år, viste en højere forekomst af epistaxis, diarré, dehydrering, træthed og perifert ødem hos patienter ≥ 65 år.
English: The frequencies of adverse reactions associated with the administration of Abraxane are listed in Table 6 (Abraxane as monotherapy) and Table 7 (Abraxane in combination with gemcitabine), and Table 9 (Abraxane in combination with carboplatin).
Danish: Hyppighederne af bivirkninger forbundet med administration af Abraxane er angivet i tabel 6 (Abraxane som monoterapi), i tabel 7 (Abraxane i kombination med gemcitabin) og i tabel 9 (Abraxane i kombination med carboplatin).
English: The effect of hepatic impairment on population pharmacokinetics of Abraxane was studied in patients with advanced solid tumours.
Danish: Virkningen af nedsat leverfunktion på populationsfarmakokinetikken af Abraxane blev undersøgt hos patienter med fremskredne solide tumorer.
English: The total combined storage time of reconstituted medicinal product in the vial and in the infusion bag when refrigerated and protected from light is 24 hours.
Danish: Den samlede opbevaringstid for det rekonstituerede lægemiddel i hætteglasset og i infusionsposen, når det opbevares i køleskab og er beskyttet mod lys, er 24 timer.
English: Of the 17 cases of pneumonitis reported in patients treated with Abraxane in combination with gemcitabine, 2 had a fatal outcome.
Danish: Ud af de 17 tilfælde af pneumonitis, som blev rapporteret hos patienter i behandling med Abraxane i kombination med gemcitabin, havde 2 dødelig udgang.
English: The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
Danish: Farmakokinetikken af total-paclitaxel efter 30- og 180-minutters infusioner af Abraxane ved doseringsniveauer på 80 til 375 mg/m2 blev bestemt i kliniske studier.
English: Alopecia was observed in >80% of the patients treated with Abraxane.
Danish: Alopeci blev observeret hos mere end 80 % af patienterne, som blev behandlet med Abraxane.
English: Rare: Radiation recall phenomenon, radiation pneumonitis
Danish: Sjælden:Radiation recall-fænomen, pneumonitis ved strålebehandling
English: People with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received Abraxane with gemcitabine in a clinical trial lived longer than people who had only received gemcitabine.
Danish: Personer med metastatisk kræft i bugspytkirtlen (kræft i bugspytkirtlen, der har spredt sig til andre dele af kroppen), som fik Abraxane sammen med gemcitabin i et klinisk studie, levede længere end personer, der kun fik gemcitabin.
English: Mild to moderate renal impairment (creatinine clearance ≥30 to <90 ml/min) has no clinically important effect on the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Danish: Let til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 til <90 ml/min) har ingen klinisk vigtig virkning på paclitaxels maksimale eliminationshastighed og systemiske eksponering (AUC og Cmax).
English: Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of Abraxane in metastatic breast cancer.
Danish: Data fra 106 patienter, der indgik i to enkeltarmede, ublindede studier og fra 454 patienter, der blev behandlet i et randomiseret fase III sammenligningsstudie understøtter brugen af Abraxane ved metastaserende brystkræft.
English: • Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight,
Danish: • Fingerneglssmerte, fingerneglsubehag, tab af fingernegle, udslæt, hudsmerte, rød hud fra sollys,
English: Table 2: Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma
Danish: Tabel 2: Dosismodifikationer for neutropeni og/eller trombocytopeni ved cyklusstart eller i løbet af en cyklus for patienter med adenokarcinom i pancreas
English: Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation.
Danish: På grund af potentielle, alvorlige bivirkninger hos ammede spædbørn er Abraxane kontraindiceret under amning.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Administer Abraxane using an infusion set incorporating a 15 µm filter to avoid administration of these strands.
Danish: Administrer Abraxane via et infusionssæt med et indsat 15 µm filter for at undgå administration af disse tråde.
English: The majority of alopecia events occurred less than one month after initiation of Abraxane.
Danish: De fleste tilfælde af alopeci forekom inden for en måned efter behandlingsstart med Abraxane.
English: Population pharmacokinetic analyses for Abraxane indicate that gender, race (Asian vs. White), and type of solid tumours do not have a clinically important effect on systemic exposure (AUC and Cmax) of paclitaxel.
Danish: Populationsfarmakokinetiske analyser af Abraxane indikerer, at køn, race (asiatisk versus hvid) og typen af solide tumorer ikke har en klinisk vigtig virkning på paclitaxels systemiske eksponering (AUC og Cmax).
English: 1st dose level reduction 2nd dose level reduction If additional dose reduction required
Danish: 1. reduktion af dosisniveau 2. reduktion af dosisniveau Hvis yderligere dosisreduktioner er nødvendige
English: Male patients treated with Abraxane are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment.
Danish: Mandlige patienter behandlet med Abraxane anbefales at anvende sikker kontraception samt at undgå at gøre kvinder gravide under og i seks måneder efter behandlingen.
English: Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose.
Danish: Efter administration anbefales det, at den intravenøse slange skylles med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske for at sikre administration af hele dosis.
English: Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.
Danish: Den samlede responsrate, tid til sygdomsprogression, progressionsfri overlevelse og samlet overlevelse for patienter, der fik >førstelinjebehandling, er vist nedenfor.
English: • People with metastatic breast cancer who received Abraxane where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.
Danish: • Personer med metastatisk brystkræft, der fik Abraxane, efter en anden behandlingsmetode ikke havde hjulpet, havde større sandsynlighed for at opleve en reduktion i tumorstørrelse og levede længere end personer, der fik en anden behandling.
English: For non-small cell lung cancer patients treated with Abraxane and carboplatin, the median time to first occurrence of Grade 3 treatment related peripheral neuropathy was 121 days, and the median time to improvement from Grade 3 treatment related peripheral neuropathy to Grade 1 was 38 days.
Danish: Hos patienter med ikke-småcellet lungecancer i behandling med Abraxane og carboplatin var mediantiden til første forekomst af behandlingsrelateret grad 3 perifer neuropati 121 dage, og mediantiden til forbedring af behandlingsrelateret grad 3 perifer neuropati til grad 1 var 38 dage.
English: • Abraxane is used in metastatic breast cancer when at least one other therapy has been tried but has not worked and you are unsuitable for treatments containing a group of medicines called “anthracyclines”.
Danish: • Abraxane anvendes til metastatisk brystkræft, når mindst en anden behandlingsmetode er blevet forsøgt, men ikke har hjulpet, og behandling med en gruppe lægemidler, der kaldes ”antracykliner”, ikke er egnet til dig.
English: In a repeat dose study with 12 patients receiving Abraxane administered intravenously at 260 mg/m2, intrapatient variability in AUC was 19% (range = 3.21%-37.70%).
Danish: I et studie med 12 patienter, der fik gentagne doser Abraxane på 260 mg/m2 i.v., var den intraindividuelle variabilitet i AUC 19 % (interval 3,21-37,70 %).
English: OR Nadir ANC <500/mm3 for > 1 week
Danish: Nadir-ANC < 500/mm3 i > 1 uge
English: For treatment of non-small cell lung cancer Abraxane is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Abraxane dose has been given.
Danish: Til behandling af ikke-småcellet lungekræft gives Abraxane én gang ugentligt (dvs. på dag 1, 8 og 15 i hver 21-dages cyklus), hvor carboplatin gives en gang hver tredje uge (dvs. kun på dag 1 i hver 21-dages cyklus), umiddelbart efter Abraxane-dosis er blevet givet.
English: What you need to know before you are given Abraxane
Danish: Det skal du vide, før du begynder at få Abraxane
English: Each ml of Abraxane contains approximately 4.2 mg of sodium.
Danish: Hver ml Abraxane indeholder cirka 4,2 mg natrium.
English: Reduce to next lower dose levela; discontinue treatment if ADR persists
Danish: Reducer til det næste lavere dosisniveaua; seponer behandlingen, hvis bivirkningen varer ved
English: flushing, thrush, severe infection in your blood which may be caused by reduced white blood cells
Danish: trøske (svampeinfektion), svær infektion i blodet, som kan være forårsaget af et nedsat antal hvide blodlegemer
English: If the suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Hvis suspensionen kommer i kontakt med huden, skal huden straks vaskes grundigt med vand og sæbe.
English: The protein binding of paclitaxel following Abraxane was evaluated by ultrafiltration in a within-patient comparison study.
Danish: Paclitaxels proteinbinding efter administration af Abraxane blev vurderet ved ultrafiltrering i et intraindividuelt sammenligningsstudie.
English: 26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006a
Danish: >Førstelinjebehandling 26,5 [18,98; 34,05] (n = 132) 13,2 [7,54; 18,93] (n = 136) 0,006a
English: Abraxane contains human serum albumin-paclitaxel nanoparticles of approximately 130 nm in size, where the paclitaxel is present in a non-crystalline, amorphous state.
Danish: Abraxane indeholder nanopartikler med en størrelse på ca. 130 nm, der består af humant serumalbumin, hvor paclitaxel findes i en ikke-krystallinsk, amorf tilstand.
English: After ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with Abraxane and gemcitabine and promptly initiate appropriate treatment and supportive measures (see section 4.2).
Danish: Efter infektiøs ætiologi er udelukket og pneumonitis diagnosticeret, seponeres Abraxane og gemcitabin permanent, og passende behandling og støttebehandling påbegyndes straks (se pkt.
English: Very common: Arthralgia, myalgia.
Danish: Meget almindelig: Artralgi, myalgi
English: This analysis included patients with normal hepatic function (n=130), and pre-existing mild (n=8), moderate (n=7), or severe (n=5) hepatic impairment (according to NCI Organ Dysfunction Working Group criteria).
Danish: Denne analyse omfattede patienter med normal leverfunktion (n=130) og let (n=8), moderat (n=7) eller svært (n=5) nedsat leverfunktion (i henhold til kriterierne fra NCI Organ Dysfunction Working Group).
English: Dose adjustments during treatment of non-small cell lung cancer:
Danish: Dosisjusteringer i løbet af behandling af ikke-småcellet lungecancer:
English: • Abraxane is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
Danish: • Abraxane anvendes sammen med et lægemiddel, der kaldes gemcitabin, hvis du har metastatisk kræft i bugspytkirtlen.
English: Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Danish: Da der ikke foreligger et farmakokinetisk lægemiddelinteraktionsstudie, bør der udvises forsigtighed, når paclitaxel indgives samtidigt med lægemidler, der vides at hæmme enten CYP2C8 eller CYP3A4 (f.eks. ketoconazol og andre imidazol-antimykotika, erythromycin, fluoxetin, gemfibrozil, clopidogrel, cimetidin, ritonavir, saquinavir, indinavir og nelfinavir), da paclitaxels toksicitet kan øges på grund af højere eksponering for paclitaxel.
English: A multicenter, multinational, randomized, open-label study was conducted in 861 patients to compare Abraxane/gemcitabine versus gemcitabine monotherapy as first-line treatment in patients with metastatic adenocarcinoma of the pancreas.
Danish: Der blev udført et multicenter, multinationalt, randomiseret, åbent studie hos 861 patienter for at sammenligne Abraxane/gemcitabin med gemcitabin-monoterapi som førstelinjebehandling hos patienter med metastatisk adenokarcinom i pancreas.
English: Of the 431 patients with pancreatic adenocarcinoma who were randomized to receive Abraxane in combination with gemcitabine, the majority (93%) were white, 4% were black and 2% were Asian.
Danish: Ud af de 431 patienter med adenokarcinom i pancreas, der blev randomiseret til Abraxane i kombination med gemcitabin, var hovedparten (93 %) hvide, 4 % var sorte og 2 % var asiatiske.
English: • Decreased or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when standing up, shaking, facial nerve paralysis
Danish: • Svage eller manglende reflekser, ufrivillige bevægelser, smerter langs en nerve, besvimelse, svimmelhed, når du rejser dig, rysten, lammelse af ansigtsnerven
English: • Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood,
Danish: • Infektion, feber med nedsat antal af en type hvide blodlegemer (neutrofiler) i blodet, blussen,
English: • if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane (listed in section 6);
Danish: • hvis du er allergisk (overfølsom) over for paclitaxel eller et af de øvrige indholdsstoffer i
English: For patients of 75 years and older, no benefit for the combination treatment of Abraxane and gemcitabine in comparison to gemcitabine monotherapy has been demonstrated.
Danish: Hos patienter på 75 år og ældre blev der ikke demonstreret en fordel af kombinationsbehandling med Abraxane og gemcitabin sammenlignet med monoterapi med gemcitabin.
English: CI = confidence interval; HRA/T = hazard ratio of Abraxane/carboplatin to solvent-based paclitaxel/carboplatin; pA/pT = response rate ratio of Abraxane/carboplatin to solvent-based paclitaxel/carboplatin.
Danish: CI = konfidensinterval, HRA/T = Hazard ratio af Abraxane/carboplatin til solvensbaseret paclitaxel/carboplatin, pA/pT = responsrate for Abraxane/carboplatin i forhold til solvensbaseret paclitaxel/carboplatin.
English: The results show that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN) has no clinically important effect on pharmacokinetics of paclitaxel.
Danish: Resultaterne viser, at let nedsat leverfunktion (totalbilirubin > 1 til ≤1,5 x øvre normalværdi) ikke har nogen klinisk vigtig virkning på paclitaxels farmakokinetik.
English: Febrile neutropenia occurred in four patients on Abraxane.
Danish: Febril neutropeni forekom hos fire patienter, som fik Abraxane.
English: Population pharmacokinetic analysis for Abraxane included patients with ages ranging from 24 to 85 years old and shows that age does not significantly influence the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Danish: En populationsfarmakokinetisk analyse af Abraxane inkluderede patienter i aldersintervallet fra 24 til 85 år og viser, at alder ikke har en signifikant indflydelse på paclitaxels maksimale eliminationshastighed og systemiske eksponering (AUC og Cmax).
English: 3 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving Abraxane monotherapy for breast cancer and for other indications using MedDRA SMQ Interstitial lung disease.
Danish: 3 Hyppigheden af pneumonitis er beregnet på grundlag af poolede data hos 1.310 patienter i kliniske studier, der fik Abraxane-monoterapi for brystkræft og for andre indikationer, på grundlag af MedDRA, SMQ interstitiel lungesygdom.
English: The study compared Abraxane in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer.
Danish: Studiet sammenlignede Abraxane i kombination med carboplatin med solvensbaseret paclitaxel i kombination med carboplatin som førstelinjebehandling hos patienter med fremskreden ikke-småcellet lungecancer.
English: Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting only, 40% in the metastatic setting only, and 19% in both metastatic and adjuvant settings.
Danish: 14 % af patienterne havde ikke tidligere fået kemoterapi; 27 % havde alene fået kemoterapi som adjuverende behandling, 40 % alene som behandling for metastaserende sygdom og 19 % havde fået både adjuverende behandling og behandling for metastaserende sygdom.
English: In the very elderly (≥75 years) who received Abraxane and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation including haematologic toxicities, peripheral neuropathy, decreased appetite and dehydration.
Danish: Hos meget ældre patienter (≥75 år), som fik Abraxane and gemcitabin, var der en højere forekomst af alvorlige bivirkninger, der førte til seponering af behandlingen, herunder hæmatologiske toksiciteter, perifer neuropati, nedsat appetit og dehydrering.
English: In patients with metastatic breast cancer, after a 30-minute infusion of Abraxane at 260 mg/m2, the mean value for cumulative urinary excretion of unchanged active substance accounted for 4% of the total administered dose with less than 1% as the metabolites 6-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel, indicating extensive non-renal clearance.
Danish: Efter 30-minutters infusion af Abraxane 260 mg/m2 til patienter med metastatisk brystkræft udgjorde den gennemsnitlige kumulative udskillelse af uomdannet aktivt stof i urinen 4 % af den totale administrerede dosis med under 1 % som metabolitterne 6-hydroxypaclitaxel og 3'-p-hydroxypaclitaxel, hvilket indikerer omfattende ikke-renal clearance.
English: If foaming or clumping occurs, the suspension should stand for at least 15 minutes until foam subsides.
Danish: Hvis der forekommer skumdannelse eller sammenklumpning, skal suspensionen stå i mindst 15 minutter, indtil skummet lægger sig.
English: The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.
Danish: Det naturlige forløb af perifer neuropati, forårsaget af kumulativ toksicitet af Abraxane efter mere end 6 behandlinger, indtil neuropatien vendte tilbage til baseline, blev ikke evalueret og forbliver ukendt.
English: There is no relevant use of Abraxane in the paediatric population in the indication of metastatic breast cancer or pancreatic adenocarcinoma or non-small cell lung cancer.
Danish: Det er ikke relevant at anvende Abraxane hos den pædiatriske population til indikationerne metastaserende brystkræft, adenokarcinom i pancreas eller ikke-småcellet lungecancer.
English: Breast cancer (Abraxane administered as monotherapy)
Danish: Brystkræft (Abraxane administreret som monoterapi)
English: There have been rare reports of reduced visual acuity due to cystoid macular oedema during treatment with Abraxane.
Danish: Der har været sjældne rapporter om nedsat synsskarphed på grund af cystoidt makulaødem under behandling med Abraxane.
English: Peripheral Neuropathy: Grade 3 or 4
Danish: Perifer neuropati: Grad 3 eller 4
English: Erlotinib should not be coadministered with Abraxane plus gemcitabine (see section 4.5).
Danish: Erlotinib bør ikke administreres sammen med Abraxane plus gemcitabin (se pkt.
English: Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Danish: Abraxane i kombination med gemcitabin er indiceret til førstelinjebehandling af voksne patienter med metastatisk adenokarcinom i pancreas.
English: Adjustment of the starting Abraxane dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥30 to <90 ml/min).
Danish: Justering af startdosis af Abraxane er ikke nødvendig for patienter med let til moderat nedsat nyrefunktion (estimeret kreatininclearance ≥ 30 til < 90 ml/min).
English: Paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see section 5.3).
Danish: Paclitaxel og/eller dets metabolitter blev udskilt i mælken hos diegivende rotter (se pkt.