FrancophonIA/ELRC3.0 huggingface dataset:
English: The non-inferiority criterion was met for PFS with the upper bound limit of the one-sided 97.5% confidence interval (CI) for the associated hazard ratio being less than 1.2.
Danish: Noninferioritetskriteriet blev opfyldt for PFS, idet den øvre grænse for det ensidede 97,5 %-konfidensinterval (KI) for den tilknyttede hazard ratio var under 1,2.
English: To avoid accidental administration into the surrounding tissue and to ensure intravenous delivery of the complete dose, flush the infusion set and catheter/cannula before as well as after the administration.
Danish: For at undgå utilsigtet indgift i det omgivende væv og sikre intravenøs indgivelse af den komplette dosis skal infusionssættet og kateteret/kanylen skylles både før og efter administration.
English: Other metabolites are 3'-p-hydroxypaclitaxel and 6α,3'-p-dihydroxypaclitaxel.
Danish: Andre metabolitter er 3'-p-hydroxypaclitaxel og 6α,3'-p-dihydroxypaclitaxel.
English: An open, randomised, multicentre study was conducted in 789 women with recurrent epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer to compare Apealea (paclitaxel micellar) in combination with carboplatin with solvent-based paclitaxel in combination with carboplatin.
Danish: Et åbent, randomiseret, multicenterstudie blev udført hos 789 kvinder med recidiv af epitelial ovariecancer, primær peritonealcancer og tubacancer for at sammenligne Apealea (paclitaxel (micellær)) i kombination med carboplatin med solvensbaseret paclitaxel i kombination med carboplatin.
English: Administration sets containing a 15 µm polyamide fluid filter should be used.
Danish: Der skal benyttes administrationssæt med et 15 µm-væskefilter af polyamid.
English: • erythromycin, rifampicin: medicines to treat bacterial infections
Danish: • erythromycin, rifampicin: lægemidler mod bakterieinfektion
English: Information is lacking for patients with severe renal impairment (GFR < 30 mL/min).
Danish: Der foreligger inden data om patienter med svært nedsat nyrefunktion (GFR < 30 ml/min).
English: The major route of excretion of paclitaxel-derived material in humans is the faeces, where 6α-hydroxypaclitaxel constitutes the main material.
Danish: Den vigtigste udskillelsesvej for paclitaxel-deriveret materiale hos mennesker er gennem fæces, hvor 6α -hydroxypaclitaxel udgør det væsentligste materiale.
English: • efavirenz, nevirapine, ritonavir, saquinavir, indinavir, nelfinavir: medicines to treat HIV
Danish: • efavirenz, nevirapin, ritonavir, saquinavir, indinavir, nelfinavir: lægemidler til behandling af hiv-infektion
English: General disorders and administration site conditions Asthenia and fatigue were very common and occurred in 23% and 11% of patients, respectively.
Danish: Almene symptomer og reaktioner på administrationsstedet Asteni og træthed var meget almindelige bivirkninger og sås hos hhv. 23 % og 11 % af patienterne.
English: In this limited number of patients, anorexia, fatigue, myalgia, arthralgia, peripheral sensory neuropathy, and diarrhoea were observed more frequently compared to patients younger than 65 years.
Danish: Hos dette begrænsede antal patienter sås anoreksi, træthed, myalgi, artralgi, perifer sensorisk neuropati og diarré hyppigere end hos patienter under 65 år.
English: Once opened, Apealea is recommended to be used immediately.
Danish: Det anbefales, at Apealea anvendes med det samme efter åbning.
English: Anaemia as serious adverse event occurred in 5% of the patients, thrombocytopenia and leukopenia in 3% and 6% of the patients, respectively.
Danish: Anæmi som alvorlig bivirkning sås hos 5 % af patienterne, trombocytopeni og leukopeni hos hhv. 3 og 6 % af patienterne.
English: Peripheral neuropathies (including the preferred terms neuropathy peripheral, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, and polyneuropathy in malignant disease) were reported in 29% of the patients and were mostly (98%) mild to moderate (CTCAE grade ≤ 2).
Danish: Der blev rapporteret om perifere neuropatier (herunder de foretrukne termer perifer neuropati, perifer motorisk neuropati, perifer sensorimotorisk neuropati, perifer sensorisk neuropati, polyneuropati og polyneuropati ved malign sygdom) hos 29 % af patienterne, og der var hovedsageligt (98 %) tale om lette til moderate tilfælde (CTCAE-grad ≤ 2).
English: Treatment should be directed at the major anticipated toxicities, which are nausea, vomiting, diarrhoea, myelosuppression, peripheral sensory neuropathy and peripheral neuropathy.
Danish: Behandling skal rettes mod de væsentligste forventede toksiciteter, dvs. kvalme, opkastning, diarré, myelosuppression, perifer sensorisk neuropati og perifer neuropati.
English: The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Danish: Metaboliseringen af paclitaxel katalyseres delvist af cytokrom P450-isoenzymerne CYP2C8 og CYP3A4 (se pkt.
English: The solution should be injected during approximately one minute towards the inner wall of the vial and not directly onto the powder as this will result in foaming.
Danish: Opløsningen skal sprøjtes i løbet af ca. et minut med kanylen rettet mod indersiden af hætteglasvæggen og ikke direkte mod pulveret, da der ellers kan dannes skum.
English: Peripheral sensory neuropathy and peripheral neuropathy are very common adverse reactions.
Danish: Perifer sensorisk neuropati og perifer neuropati er meget almindelige bivirkninger.
English: The biotransformation and elimination of paclitaxel have been reported in published studies; paclitaxel is mainly eliminated by hepatic metabolism and biliary excretion.
Danish: Med hensyn til paclitaxels biotransformation og elimination fremgår det af publicerede studier, at paclitaxel fortrinsvis elimineres ved hepatisk metabolisering og biliær udskillelse.
English: Mutagenesis, carcinogenesis, impairment of fertility
Danish: Mutagenicitet, karcinogenicitet, nedsat fertilitet
English: Apealea is given to you by a doctor or nurse by a slow drip (infusion) into a vein.
Danish: Du vil få indgivet Apealea af en læge eller sygeplejerske via et drop i en blodåre (infusion).
English: • high blood pressure, blood pressure changes, paleness
Danish: • højt blodtryk, blodtryksændringer, bleghed
English: There are limited data of Apealea in non-Caucasian patients and current data is insufficient to recommend additional dose adjustments (see section 4.4).
Danish: Der foreligger kun begrænsede data om anvendelse af Apealea hos ikke-kaukasiske patienter, og dataene er utilstrækkelige til at kunne anbefale eventuel yderligere dosisjustering (se pkt.
English: Studies in animals being treated with paclitaxel have shown decreased fertility (see section 5.3).
Danish: Studier af dyr, der har fået paclitaxel, har vist nedsat fertilitet (se pkt.
English: • low level of blood platelets or red blood cells
Danish: • lavt antal blodplader eller røde blodlegemer
English: − formation of blood clots
Danish: − dannelse af blodpropper
English: The usual dose is 250 mg/m2 body surface area given every three weeks for up to six treatments.
Danish: Den sædvanlige dosis er 250 mg/m2 legemsoverflade indgivet hver 3. uge i op til 6 behandlingsserier.
English: • low blood pressure, flushing, vein inflammation, vein pain, increased blood flow to some parts of the body
Danish: • lavt blodtryk, rødme, betændelse i blodkar, smerter i blodkar, øget blodtilførsel til nogle dele af kroppen
English: Unopened vials: Store in a refrigerator (2 °C - 8 °C).
Danish: Uåbnede hætteglas: Opbevares i køleskab (2 °C - 8 °C).
English: • fluoxetine: a medicine to treat depression
Danish: • fluoxetin: et lægemiddel mod depression
English: − breathing difficulties
Danish: − vejrtrækningsbesvær
English: Based on limited data, Cmax and AUC increased with dose after 1-hour infusions of Apealea in doses ranging from 150 to 275 mg/m2.
Danish: Begrænsede data viste, at Cmax og AUC øgedes med dosis efter 1-times infusioner af Apealea i doser på 150-275 mg/m2.
English: Withhold treatment until symptoms resolve to grade ≤ 1
Danish: Indstil behandlingen indtil bedring til grad ≤ 1
English: Swirl the vial again in upright position for approximately 20 seconds, then gently invert it five times.
Danish: Drej hætteglasset igen i opret stilling frem og tilbage i ca. 20 sekunder, og vend det dernæst op og ned fem gange.
English: Alopecia was observed in 45% of patients and was abrupt in onset.
Danish: Alopeci sås hos 45 % af patienterne og havde en pludselig debut.
English: After reconstitution, each mL of solution contains up to approximately 3.60 mg (0.157 mmol) sodium.
Danish: Efter rekonstitution indeholder hver ml opløsning op til ca. 3,60 mg (0,157 mmol) natrium.
English: Apealea: solvent-based paclitaxel:
Danish: Apealea: Solvensbaseret paclitaxel:
English: Apealea contains sodium
Danish: Apealea indeholder natrium
English: Apealea is a cancer medicine containing the active substance paclitaxel, which belongs to a group of medicines called taxanes.
Danish: Det indeholder det aktive stof paclitaxel, som tilhører en gruppe lægemidler, der kaldes taxaner.
English: b The dose of carboplatin should be reduced by 1 AUC unit for treatment cycles following the occurrence of febrile neutropenia or low platelet count (< 75 × 109/L).
Danish: b Carboplatin-dosen bør reduceres med 1 AUC-enhed i behandlingsserierne efter forekomst af febril neutropeni eller lavt trombocyttal (< 75 × 109/l).
English: In addition, paclitaxel induces microtubule bundle formation throughout the cell cycle and induces microtubule aster formation during mitosis.
Danish: Desuden inducerer paclitaxel dannelse af mikrotubulusbundter gennem hele cellecyklussen og inducerer dannelse af mikrotubulus-asters under mitosen.
English: Apealea has been given as monotherapy in a total of 132 patients at doses ranging between 90 mg/m2 in a 3-week regimen to weekly doses of 250 mg/m2 for various indications.
Danish: Apealea er givet som enkeltstofbehandling til i alt 132 patienter i doser, der varierede mellem 90 mg/m2 i et 3-ugers regime og ugentlige doser på 250 mg/m2 til forskellige indikationer.
English: − nerve disorder in arms and legs which causes tingling, numbness or burning pain*
Danish: − nerveforstyrrelse i arme og ben, der kan give stikkende fornemmelse, brændende smerte eller følelsesløshed*
English: In particular, tell your doctor or nurse before you are given Apealea if you are using:
Danish: Du skal navnlig sige det til lægen eller sygeplejersken, før du får Apealea, hvis du bruger:
English: Non-inferiority analyses on PFS and OS in a randomised trial in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (PP population)a
Danish: Non-inferioritetsanalyser for PFS og OS i et randomiseret studie hos patienter med recidiv af epitelial ovariecancer, primær peritonealcancer og tubacancer (PP-population)a
English: Median time to death [months] (95% CI)
Danish: Median tid til død [måneder] (95 %-KI)
English: • primary peritoneal cancer - a cancer of the cells lining the space between the wall of the belly and the internal organs
Danish: • primær bughindekræft - en kræftsygdom i bughindens celler, dvs. den hinde, der beklæder bughulens vægge og de indre organer i bughulen
English: Baseline neutrophil count < 1.5 × 109/L.
Danish: Neutrofiltal ved baseline < 1,5 × 109/l.
English: Patients with hepatic impairment have not been studied with Apealea but may be at increased risk of toxicity, particularly from myelosuppression.
Danish: Apealea er ikke undersøgt hos patienter med nedsat leverfunktion, men disse patienter kan have øget risiko for toksicitet, navnlig som følge af myelosuppression.
English: These patients should be vigilantly monitored by physicians for the occurrence of cardiac events.
Danish: Lægerne bør overvåge disse patienter meget omhyggeligt for hjertehændelser.
English: Dose recommendations for Apealea as well as for carboplatin in the case of myelosuppression should be followed (see section
Danish: Dosisanbefalingerne for Apealea og carboplatin ved myelosuppression bør følges (se pkt.
English: Uncommon: Vertigo, deafness, inner ear disorder, tinnitus
Danish: Ikke almindelig: Vertigo, døvhed, forstyrrelse i det indre øre, tinnitus
English: Solvent-based paclitaxel
Danish: Solvensbaseret paclitaxel
English: • ketoconazole, or other medicines to treat fungal infections
Danish: • ketoconazol eller andre lægemidler mod svampeinfektion
English: Patients with mildly or moderately impaired renal function (glomerular filtration rate (GFR) 89−60 mL/min or GFR 59−30 mL/min, respectively) may be treated with Apealea without a dose modification.
Danish: Patienter med let til moderat nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) på hhv. 89-60 ml/min og 59-30 ml/min) kan behandles med Apealea uden ændring af dosis.
English: In the study, 35% of the patients in the paclitaxel micellar group and 30% of the patients in the solvent-based paclitaxel group, respectively, received GCSF to treat neutropenia.
Danish: 35 % af patienterne i studiet i gruppen med paclitaxel (micellær), og 30 % af patienterne i gruppen med solvensbaseret paclitaxel fik G-CSF til behandling af neutropeni.
English: Therefore, 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: Derfor bør der udvises forsigtighed ved samtidig administration af paclitaxel og lægemidler, der er kendte hæmmere af enten CYP2C8 eller CYP3A4 (f.eks. ketoconazol og andre imidazol-svampemidler, erythromycin, fluoxetin, gemfibrozil, clopidogrel, cimetidin, ritonavir, saquinavir, indinavir og nelfinavir), da toksiciteten ved paclitaxel kan øges på grund af større paclitaxel-eksponering.
English: The most common clinically significant adverse reactions associated with the use of Apealea are neutropenia, gastrointestinal disorders, peripheral neuropathy, arthralgia/myalgia, and infusion site reactions.
Danish: De mest almindelige klinisk signifikante bivirkninger, der er forbundet med anvendelse af Apealea, er neutropeni, gastrointestinale forstyrrelser, perifer neuropati, artralgi/myalgi og reaktioner på infusionsstedet.
English: It should not be interchanged with other paclitaxel formulations.
Danish: Det må ikke udskiftes med andre paclitaxel-formuleringer.
English: Median months (95% CI)
Danish: Median måneder (95 % KI)
English: No analysis of the effect of age, gender or body size on the elimination of Apealea has been undertaken.
Danish: Betydningen af alder, køn, etnisk oprindelse og kropsstørrelse Det er ikke undersøgt, hvilken indvirkning alder, køn og kropsstørrelse har på eliminationen af Apealea.
English: • low blood levels of potassium, magnesium or sodium
Danish: • lavt niveau af kalium, magnesium eller natrium i blodet
English: Women of childbearing potential must use effective contraception during treatment and for six months afterwards.
Danish: Kvinder, der kan blive gravide, skal anvende sikker prævention under behandlingen og i 6 måneder efter endt behandling.
English: Patients that have total bilirubin > 5 × ULN or AST > 10 × ULN should not be treated with paclitaxel.
Danish: Patienter med total bilirubin > 5 × ULN eller ASAT > 10 × ULN bør ikke behandles med paclitaxel.
English: Most hypersensitivity reactions related to Apealea are mild to moderate and mainly occur as skin and subcutaneous tissue disorders, general disorders and administration site conditions, but serious hypersensitivity reactions including anaphylactic shock have been reported.
Danish: De fleste overfølsomhedsreaktioner ved anvendelse af Apealea er lette til moderate og viser sig typisk som symptomer i huden og det subkutane væv og som almene symptomer og reaktioner på administrationsstedet, men der er også rapporteret om alvorlige overfølsomhedsreaktioner, herunder anafylaktisk shock.
English: In the case of febrile neutropenia or low platelet count (< 75 × 109/L), the dose of carboplatin should be reduced by 1 AUC unit in the treatment cycles following recovery.
Danish: Ved febril neutropeni eller lavt trombocyttal (< 75 × 109/l) bør carboplatin-dosen reduceres med 1 AUC-enhed i behandlingsserierne efter bedringen.
English: The proportions of patients treated at first or second relapse were then equal in both treatment groups (76% were treated at first relapse and 24% at second relapse).
Danish: Andelen af patienter, der blev behandlet efter første recidiv, og andelen af patienter, der blev behandlet efter andet recidiv, var da lige stor i de to behandlingsgrupper (76 % blev behandlet efter første recidiv og 24 % efter andet recidiv).
English: Patients with severe renal impairment (GFR < 30 mL/min) should not be treated with paclitaxel (see section 5.2).
Danish: Patienter med svært nedsat nyrefunktion (GFR < 30 ml/min) bør ikke behandles med paclitaxel (se pkt.
English: Premedication was not mandated prior to infusion of paclitaxel micellar.
Danish: Præmedicinering var ikke påkrævet forud for infusion af paclitaxel (micellær).
English: Package leaflet: Information for the user Apealea 60 mg powder for solution for infusion paclitaxel
Danish: Indlægsseddel: Information til brugeren Apealea 60 mg pulver til infusionsvæske, opløsning paclitaxel
English: Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Danish: Samtidig administration af paclitaxel og lægemidler, der er kendte inducere af enten CYP2C8 eller CYP3A4 (f.eks. rifampicin, carbamazepin, phenytoin, efavirenz, nevirapin), anbefales ikke, da effekten af paclitaxel kan svækkes på grund af lavere paclitaxel-eksponering.
English: Swirl the vial in an upright position for approximately for 20 seconds.
Danish: Drej hætteglasset i opret stilling frem og tilbage i ca. 20 sekunder.
English: What you need to know before you are given Apealea Do not use Apealea if you:
Danish: Det skal du vide, før du begynder at få Apealea Brug ikke Apealea:
English: Based on the published literature, in vitro studies indicate that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine does not affect protein binding of paclitaxel.
Danish: In vitro-studier viser, at tilstedeværelsen af cimetidin, ranitidin, dexamethason eller diphenhydramin ikke har nogen indvirkning på paclitaxels proteinbinding, jf. den publicerede litteratur.
English: • sensation of heaviness in the legs
Danish: • tyngdefølelse i benene
English: • reduced liver, kidney or heart function
Danish: • hvis du har nedsat lever-, nyre- eller hjertefunktion
English: The frequency of undesirable effects listed in Table 2 is defined using the following convention: 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), and not known (cannot be estimated from the available data).
Danish: sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Second dose level reduction: a Grade of the adverse reaction is defined according to Common Terminology Criteria for Adverse Events (CTCAE).
Danish: Common Terminology Criteria for Adverse Events (CTCAE).
English: Neutropenia resolved to ≥ 1.5 × 109/L before the next course of treatment.
Danish: Neutropeni bedredes til ≥ 1,5 × 109/l før den efterfølgende behandlingsserie.
English: Apealea has moderate influence on the ability to drive or use machines.
Danish: Apealea påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: First dose level reduction:
Danish: Første dosisreduktion:
English: − build-up of water in tissue because of blocked lymph vessel
Danish: − væskeophobning i vævet på grund af blokerede lymfekar
English: There were more reports of infusion site pain in the group receiving paclitaxel micellar as compared to the group treated with solvent-based paclitaxel (8% and 1%, respectively).
Danish: Der var flere rapporter om smerter på infusionsstedet i den gruppe, der fik paclitaxel (micellær), end i den gruppe, der fik solvensbaseret paclitaxel (hhv. 8 % og 1 %).
English: In the pivotal clinical study, patients were either treated with Apealea (paclitaxel micellar) at a dose of 250 mg/m2 in combination with carboplatin or with solvent-based paclitaxel at a dose of 175 mg/m2 in combination with carboplatin (N = 391 in each arm).
Danish: I det pivotale kliniske studie blev patienterne enten behandlet med Apealea (paclitaxel (micellær)) i en dosis på 250 mg/m2 i kombination med carboplatin eller med solvensbaseret paclitaxel i en dosis på 175 mg/m2 i kombination med carboplatin (N = 391 i begge grupper).
English: Erythema, rash, pruritus, urticaria
Danish: Erytem, udslæt, pruritus, urticaria
English: • skin inflammation with blisters
Danish: • betændelse i huden med blister
English: The main metabolite of paclitaxel is 6α-hydroxypaclitaxel.
Danish: Paclitaxels hovedmetabolit er 6α -hydroxypaclitaxel.
English: The recommended dose of Apealea is 250 mg/m2 body surface area (BSA) given as an intravenous infusion over 1 hour followed by carboplatin every three weeks for six cycles.
Danish: Den anbefalede dosis Apealea er 250 mg/m2 legemsoverflade (BSA) indgivet som en intravenøs infusion over 1 time efterfulgt af carboplatin hver 3. uge i seks serier.
English: Listing of adverse reactions System Organ Class
Danish: Tabel 2: Oversigt over bivirkninger Systemorganklasse
English: The non-inferiority criterion was met for OS in the PP population with the upper bound limit of the one-sided 97.5% CI for the associated hazard ratio being less than 1.185 (Table 4; Figures 1 and 2).
Danish: Noninferioritetskriteriet blev opfyldt for OS hos PP-populationen, idet den øvre grænse for det ensidede 97,5 %-KI for den tilknyttede hazard ratio var under 1,185 (tabel 4; figur 1 og 2).
English: • weakness, tiredness
Danish: • svaghed, træthed
English: Renal excretion accounts for a minor part, less than 15% of the dose.
Danish: En mindre del udskilles gennem nyrerne (under 15 % af dosis).
English: A population pharmacokinetics study with albumin-bound paclitaxel demonstrated that patients with mild and moderate renal impairment (creatinine clearance ≥ 30 to < 90 mL/min) have an elimination rate similar to that of patients with normal renal function.
Danish: Et farmakokinetisk populationsstudie med albumin-bundet paclitaxel viste, at patienter med let og moderat nedsat nyrefunktion (kreatininclearance ≥ 30-< 90 ml/min) havde en eliminationshastighed, der svarer til eliminationshastigheden hos patienter med normal nyrefunktion.
English: Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (see section 5.1).
Danish: Apealea i kombination med carboplatin er indiceret til behandling af voksne patienter med første recidiv af platinfølsom epitelial ovariecancer, primær peritonealcancer og tubacancer (se pkt.
English: Apealea may cause side effects such as tiredness or dizziness that may reduce your ability to drive or use machines.
Danish: Apealea kan give bivirkninger som træthed eller svimmelhed, der kan nedsætte evnen til at føre motorkøretøj og betjene maskiner.
English: Cytotoxic Apealea should not be interchanged with other paclitaxel formulations.
Danish: Cytotoksisk Apealea må ikke udskiftes med andre paclitaxel-formuleringer.
English: Uncommonly these can lead to severe allergic shock.
Danish: Dette kan i nogle tilfælde føre til alvorligt allergisk shock (ikke almindelig bivirkning).
English: Apealea should not be interchanged with other paclitaxel formulations.
Danish: Apealea bør ikke udskiftes med andre paclitaxel-formuleringer.
English: Kaplan-Meier curve of OS (PP population)
Danish: Kaplan-Meier-kurve for OS (PP-population)