FrancophonIA/ELRC3.0 huggingface dataset:
English: The median duration of open-label treatment was 47.7 weeks among all patients; 67.1 weeks in the 53 patients randomised to everolimus who switched to open-label everolimus and 44.1 weeks in the 172 patients randomised to placebo who switched to open-label everolimus.
Danish: Den mediane varighed af åben behandling var 47,7 uger blandt alle patienter; 67,1 uger for de 53 patienter, der blev randomiseret til everolimus, og som skiftede til open-label everolimus, og 44,1 uger hos de 172 patienter, der blev randomiseret til placebo, og som skiftede til open-label everolimus.
English: The estimated HR was 1.27 (90% CI: 0.95, 1.70) for the comparison of OS in the everolimus alone arm relative to the everolimus + exemestane arm.
Danish: Den estimerede HR var 1,27 (90 % CI: 0,95; 1,70) for sammenligningen af OS i everolimus alene-armen i forhold til everolimus + exemestan-armen.
English: Consider re-initiating treatment at 5 mg daily.
Danish: Overvej at genoptage behandlingen med 5 mg daglig.
English: Absence of menstrual periods (amenorrhoea) has been observed in some female patients receiving Afinitor.
Danish: Kvinders frugtbarhed Der er observeret udeblivelse af menstruationen (amenoré) hos nogle kvinder, der får Afinitor.
English: 10 tablets 30 tablets 90 tablets
Danish: 10 tabletter 30 tabletter 90 tabletter
English: St. John's wort (Hypericum perforatum), a herbal product used to treat depression and other conditions.
Danish: perikon (Hypericum perforatum)- et naturlægemiddel, der bruges til behandling af depression og andre tilstande.
English: If co-administration of a moderate CYP3A4 and/or PgP inhibitor or inducer cannot be avoided, dose adjustments of Afinitor can be taken into consideration based on predicted AUC (see section 4.5).
Danish: Hvis samtidig administration af en moderat CYP3A4- og/eller PgP-hæmmer eller induktor ikke kan undgås, kan det overvejes at foretage dosisjusteringer af Afinitor baseret på forventet AUC (se pkt.
English: Blood tests will also be carried out to check your kidney function (level of creatinine) and liver function (level of transaminases) and your blood sugar and cholesterol levels.
Danish: Der vil også blive taget blodprøver for at kontrollere din nyrefunktion (kreatinin-tal), leverfunktion (transaminase-tal), dit blodsukker og dit kolesteroltal, fordi disse tal også kan påvirkes af Afinitor.
English: In clinical trials and post-marketing spontaneous reports, angioedema has been reported with and without concomitant use of ACE inhibitors (see section 4.4).
Danish: I kliniske studier og spontane rapporter modtaget efter markedsføring er angioødem blevet rapporteret med og uden samtidig behandling med ACE inhibitorer (se punkt 4.4).
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with everolimus (see section 5.3).
Danish: Baseret på prækliniske fund kan fertiliteten hos hanner og hunner kompromitteres af behandling med everolimus (se pkt.
English: The median duration of exemestane treatment was longer in the everolimus + exemestane group at 29.5 weeks (1.0-199.1) compared to 14.1 weeks (1.0-156.0) in the placebo + exemestane group.
Danish: Den mediane behandlingsvarighed med exemestan var længere i everolimus + exemestan-gruppen: 29,5 uger (1,0-199,1) sammenlignet med 14,1 uger (1,0-156,0) i placebo + exemestan-gruppen.
English: Butylhydroxytoluene Magnesium stearate Lactose monohydrate Hypromellose Crospovidone type A Lactose anhydrous
Danish: Butylhydroxytoluen Magnesiumstearat Lactosemonohydrat Hypromellose Crospovidon type A Lactose, vandfri
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must use a highly effective method of contraception (e.g. oral, injected, or implanted non-oestrogen-containing hormonal method of birth control, progesterone-based contraceptives, hysterectomy, tubal ligation, complete abstinence, barrier methods, intrauterine device [IUD], and/or female/male sterilisation) while receiving everolimus, and for up to 8 weeks after ending treatment.
Danish: Kvinder i den fertile alder/Kontraception til mænd og kvinder Kvinder i den fertile alder skal anvende yderst sikker kontraception (fx orale, injicerede eller implanterede ikke-østrogenholdige hormonale præventionsmetoder, progesteron-baserede kontraceptiva, hysterektomi, aflukning af æggeledere, fuldstændig afholdenhed, barriereprævention, intrauterin prævention [IUD] og/eller kvindelig/mandlig sterilisation) under behandlingen med everolimus og i op til 8 uger efter endt behandling.
English: Figure 5 RADIANT-4 - Progression free survival results by pre-specified patient subgroup (independent radiological review)
Danish: Figure 5 RADIANT-4 - Resultater for progressionsfri overlevelse i præ-specificerede undergrupper (uafhængig radiologisk vurdering)
English: Includes (very common) pneumonitis, (common) interstitial lung disease, lung infiltration and (rare) pulmonary alveolar haemorrhage, pulmonary toxicity, and alveolitis d
Danish: Inklusive (meget almindelig) pneumonitis, (almindelig) interstitiel lungesygdom, lungeinfiltration og (sjælden) pulmonal alveolær blødning, pulmonal toksicitet og alveolitis d
English: Telithromycin, clarithromycin Nefazodone Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir
Danish: Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir
English: Vaccinations The use of live vaccines should be avoided during treatment with Afinitor (see section 4.5).
Danish: Vaccinationer Anvendelse af levende vacciner bør undgås under behandling med Afinitor (se pkt.
English: • Headache, dizziness (sign of high blood pressure, also known as hypertension)
Danish: • Hovedpine, svimmelhed (tegn på forhøjet blodtryk, også kendt som hypertension)
English: Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Danish: Afinitor er indiceret til behandling af patienter med progressiv renalcellekarcinom, hvis sygdom er progredieret under eller efter behandling med vaskulær endotel vækstfaktor (VEGF) målrettet terapi.
English: Censoring Times
Danish: Censureringstid
English: Impaired wound healing is a class effect of rapamycin derivatives, including everolimus.
Danish: Nedsat sårheling er en klasseeffekt af rapamycinderivater, inklusiv everolimus.
English: In a post-marketing single-arm study in postmenopausal women with advanced breast cancer (N=92), topical treatment with dexamethasone 0.5 mg/5 ml alcohol-free oral solution was administered as a mouthwash (4 times daily for the initial 8 weeks of treatment) to patients at the time of initiating treatment with Afinitor (10 mg/day) plus exemestane (25 mg/day) to reduce the incidence and severity of stomatitis.
Danish: I et post-marketing, enkeltarms-studie med postmenopausale kvinder med fremskreden brystkræft (N=92) blev der administreret topikal behandling med en alkoholfri oral opløsning med dexamethason 0,5 mg/5 ml som mundskyllevæske (4 gange daglig i de første 8 ugers behandling) til patienter ved opstart af behandling med Afinitor (10 mg/daglig) plus exemestan (25 mg/daglig) for at reducere forekomsten og alvorligheden af stomatitis.
English: Concomitant treatment of Afinitor and potent inhibitors is not recommended.
Danish: Samtidig behandling med Afinitor og potente hæmmere frarådes.
English: Mean oral clearance (CL/F) of everolimus after 10 mg daily dose in patients with advanced solid tumours was 24.5 l/h.
Danish: Middelværdien af oral clearance (CL/F) for everolimus efter en daglig dosis på 10 mg var 24,5 l/t hos patienter med progressive solide tumorer.
English: Hazard ratio p value
Danish: Risiko-ratio p-værdi
English: Hepatic impairment Mild hepatic impairment (Child-Pugh A) - the recommended dose is 7.5 mg daily.
Danish: Nedsat leverfunktion Let nedsat leverfunktion (Child-Pugh A): Den anbefalede startdosis er 7,5 mg daglig.
English: • Tiredness, breathlessness, dizziness, pale skin (signs of low level of red blood cells, possibly due to a type of anaemia called pure red cell aplasia)
Danish: • Træthed, stakåndethed, svimmelhed, bleg hud (tegn på lavt niveau af røde blodlegemer, der muligvis skyldes en type blodmangel, der kaldes pure red cell aplasia)
English: Secondary endpoints included overall survival (OS), overall response rate, disease control rate, safety, change in quality of life (FACT-G) and time to World Health Organisation performance status (WHO PS) deterioration.
Danish: De sekundære endepunkter omfattede total overlevelse (OS), total responsrate, sygdomskontrolrate, sikkerhed, ændring i livskvalitet (FACT-G) og tid til forværring af World Health Organisation performance-status (WHO PS).
English: • Nail disorders, breaking of your nails
Danish: • Neglesygdomme, knækkede negle
English: Dose adjustments should be made if a patient's hepatic (Child-Pugh) status changes during treatment (see also sections 4.4 and 5.2).
Danish: Dosisjustering bør foretages, hvis patientens leverfunktion (Child-Pugh) ændres under behandlingen (se også pkt.
English: Moderate CYP3A4/PgP inhibitors Erythromycin
Danish: Moderate CYP3A4/PgP-hæmmere Erythromycin
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
Danish: I kliniske studier og post-marketing spontane rapporter er everolimus blevet forbundet med alvorlige tilfælde af hepatitis B reaktivering, inklusive letale tilfælde.
English: Other secondary objectives included the evaluation of OS, objective response rate, clinical benefit rate, safety, time to ECOG performance deterioration, time to QoL deterioration, and treatment satisfaction (TSQM).
Danish: Øvrige sekundære formål inkluderede evalueringen af OS, objektiv responsrate, rate for klinisk fordel, sikkerhed, tid til forværring af ECOG performance, tid til forværring af QoL og tilfredshed med behandlingen (TSQM).
English: Log-rank p value: <0.0001
Danish: Log-rank p værdi: <0,0001
English: No. of patients still at risk Time (months) Afinitor
Danish: Antal patienter med fortsat risiko Tid (måneder)
English: Secondary endpoints included safety, objective response rate, response duration and overall survival (OS).
Danish: Sekundære endepunkter inkluderede sikkerhed, objektiv responsrate, responsvarighed og total overlevelse (OS).
English: A total of 309 patients were randomised in a 1:1:1 ratio to the combination of everolimus (10 mg daily) + exemestane (25 mg daily) (n=104), everolimus alone (10 mg daily) (n=103), or capecitabine (1250 mg/m dose twice daily for 2 weeks followed by one week rest, 3-week cycle) (n=102).
Danish: I alt blev 309 patienter randomiseret i en 1:1:1 ratio til kombinationen af everolimus (10 mg dagligt) + exemestan (25 mg dagligt) (n=104), everolimus alene (10 mg dagligt) (n=103) eller capecitabin (1250 mg/m2-dosis to gange dagligt i 2 uger, efterfulgt af en uges pause, 3 ugers cyklus) (n=102).
English: Afinitor is only recommended for use in patients with severe hepatic impairment (Child-Pugh C) if the potential benefit outweighs the risk (see sections 4.2 and 5.2).
Danish: Afinitor er kun anbefalet til behandling af patienter med stærkt nedsat leverfunktion (Child-Pugh C), hvis de potentielle fordele opvejer risiciene (se pkt.
English: Secondary endpoints included safety, objective tumour response rate, overall survival, disease-related symptoms, and quality of life.
Danish: De sekundære endepunkter omfattede sikkerhed, objektiv tumorresponsrate, overlevelse, sygdomsrelaterede symptomer og livskvalitet.
English: The primary endpoint for the study was PFS evaluated by RECIST (Response Evaluation Criteria in Solid Tumors).
Danish: Det primære endepunkt for studiet var PFS evauleret ved RECIST (Response Evaluation Criteria in Solid Tumours).
English: • Fever, sore throat, mouth ulcers due to infections (signs of low level of white blood cells,
Danish: • Feber, ondt i halsen, mundsår pga. infektioner (tegn på et lavt antal hvide blodlegmer,
English: • Fever, skin rash, joint pain and inflammation, as well as tiredness, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools, dark urine (may be signs of hepatitis B reactivation)
Danish: • Feber, hududslæt, smerter og inflammation (betændelseslignende reaktion) i led samt træthed, appetitløshed, kvalme, gulsot (gullig hud), smerter i den øverste højre del af maven, lys afføring, mørk urin (kan være tegn på opblussen af hepatitis B-infektion)
English: At the time of data cut-off, the median duration of treatment was 27.5 weeks (range 2.0-165.7) in the everolimus + exemestane arm, 20 weeks (1.3-145.0) in the everolimus arm, and 26.7 weeks (1.4-177.1) in the capecitabine arm.
Danish: Ved tidspunktet for data cut-off, var median-varigheden af behandling 27,5 uger (interval 2,0-165,7) i everolimus + exemestan-armen, 20 uger (1,3-145,0) i everolimus-armen og 26,7 uger (1,4-177,1) i capecitabin-armen.
English: Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, andre rapamycin-derivater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Demographics and disease characteristics were generally balanced (median age 63 years [range 22 to 86], 76% Caucasian, history of prior somatostatin analogue [SSA] use).
Danish: Demografiske karakteristika og sygdomskarakteristika var generelt velbalancerede (medianalder 63 år [interval 22 til 86], 76 % kaukasier, behandling med somatostatinanaloger (SSA) i anamnesen).
English: What Afinitor contains The active substance is everolimus.
Danish: Afinitor indeholder: Aktivt stof: everolimus.
English: • Dry mouth
Danish: • Tør mund
English: Median overall survival (months) (95% CI) Median overall survival
Danish: Median total overlevelse (måneder) (95% CI) Median total overlevelse
English: Secondary endpoints included overall survival (OS), objective response rate, clinical benefit rate, safety, change in quality of life (QoL) and time to ECOG PS (Eastern Cooperative Oncology Group performance status) deterioration.
Danish: De sekundære endepunkter omfattede total overlevelse (OS), objektiv responsrate, rate for klinisk fordel, sikkerhed, ændring i livskvalitet (QoL) og tid til forværring af ECOG PS (Eastern Cooperative Oncology Group performance status).
English: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with Afinitor (see section 4.8).
Danish: Der er observeret tilfælde af nyresvigt (inklusive akut nyresvigt), nogle med letalt udfald, hos patienter behandlet med Afinitor (se pkt.
English: Agents whose plasma concentration may be altered by everolimus Based on in vitro results, the systemic concentrations obtained after oral daily doses of 10 mg make inhibition of PgP, CYP3A4 and CYP2D6 unlikely.
Danish: Lægemidler, hvis plasmakoncentration kan blive påvirket af everolimus Baseret på in vitro resultater, er det usandsynligt, at PgP, CYP3A4 og CYP2D6 hæmmes ved de systemiske koncentrationer, der opnås efter daglig oral dosis af 10 mg. Hæmning af CYP3A4 og PgP i tarmen kan dog ikke udelukkes.
English: If patients require co-administration of a potent CYP3A4 inducer, an Afinitor dose increase from 10 mg daily up to 20 mg daily should be considered using 5 mg increments or less applied on Day 4 and 8 following start of the inducer.
Danish: Hvis en patient har brug for samtidig administration af potente CYP3A4-hæmmere, bør det overvejes at øge Afinitor-dosis fra 10 mg/dag til 20 mg/dag med stigninger på 5 mg eller mindre på dag 4 og 8 og derefter opstart af behandling med induktor.
English: How to take Afinitor
Danish: Sådan skal du tage Afinitor
English: The most frequent Grade 3-4 adverse reactions (incidence ≥1/100 to <1/10) were stomatitis, anaemia, hyperglycaemia, infections, fatigue, diarrhoea, pneumonitis, asthenia, thrombocytopenia, neutropenia, dyspnoea, proteinuria, lymphopenia, haemorrhage, hypophosphataemia, rash, hypertension, pneumonia, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased and diabetes mellitus.
Danish: De hyppigste bivirkninger af Grad 3-4 (hyppighed ≥1/100 til <1/10) var stomatitis, anæmi, hyperglykæmi, infektioner, træthed, diarré, pneumonitis, asteni, trombocytopeni, neutropeni, dyspnø, proteinuri, lymfopeni, hæmoragi, hypofosfatæmi, udslæt, hypertension, pneumoni, forhøjet alaninaminotransferase (ALAT), forhøjet aspartat-aminotransferase (ASAT) og diabetes mellitus.
English: • Spontaneous bleeding or bruising (signs of low level of platelets, also known as thrombocytopenia)
Danish: • Spontan blødning eller blå mærker (tegn på lavt niveau af blodplader, også kendt som trombocytopeni)
English: Monitoring of blood cholesterol and triglycerides prior to the start of Afinitor therapy and periodically thereafter, as well as management with appropriate medical therapy, is recommended.
Danish: Monitorering af kolesterol og triglycerider i blodet før opstart af behandling med Afinitor og periodisk herefter samt passende medicinsk behandling anbefales.
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with cases of PJP/PCP, some with fatal outcome (see section 4.4).
Danish: I kliniske studier og spontane rapporter modtaget efter markedsføring er everolimus blevet associeret med tilfælde af PJP/PCP, hvoraf nogle var med letal udgang (se punkt 4.4).
English: Includes (very common) stomatitis, (common) aphthous stomatitis, mouth and tongue ulceration and (uncommon) glossodynia, glossitis e
Danish: Inklusive (meget almindelig) stomatitis, (almindelig) aftøs stomatitis, mund- og tungeulceration og (ikke almindelig) glossodyni, glossitis e
English: Advanced neuroendocrine tumours of pancreatic origin (pNET) RADIANT-3 (study CRAD001C2324), a phase III, multicentre, randomised, double-blind study of Afinitor plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pNET, demonstrated a statistically significant clinical benefit of Afinitor over placebo by a 2.4-fold prolongation of median progression-free-survival (PFS) (11.04 months versus 4.6 months), (HR 0.35; 95% CI: 0.27, 0.45; p<0.0001) (see Table 5 and Figure 3).
Danish: Progressive neuroendokrine tumorer udgået fra pancreas (pNET) RADIANT-3 (studier CRAD001C2324), et fase-III, multicenter, randomiseret, dobbeltblindet studie af Afinitor plus bedste understøttende behandling (BSC) versus placebo samt BSC hos patienter med fremskreden pNET, viste en statistisk signifikant klinisk fordel ved behandling med Afinitor i forhold til placebo, med en 2,4 gange forlængelse af den mediane progressionsfri overlevelse (PFS) (11,04 måneder versus 4,6 måneder) (HR 0,35; 95% CI: [0,27; 0,45]; p<0,0001) (se tabel 5 og figur 3).
English: Hormone receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Danish: Afinitor er indiceret til behandling af fremskreden hormonreceptorpositiv, HER2/neu-negativ brystcancer i kombination med exemestan hos postmenopausale kvinder uden symptomatisk, visceral sygdom efter recidiv eller progression efter en non-steroid aromatasehæmmer.
English: The use of live vaccines should be avoided during treatment with Afinitor (see section 4.4).
Danish: Anvendelse af levende vacciner bør undgås under behandling med Afinitor (se pkt.
English: Preparations containing St John's Wort should not be used during treatment with everolimus
Danish: Naturlægemidler indeholdende perikon må ikke anvendes under behandling med everolimus.
English: In total, 416 patients were randomised 2:1 to receive Afinitor (n=277) or placebo (n=139).
Danish: I alt blev 416 patienter randomiseret 2:1 til at modtage Afinitor (n=277) eller placebo (n=139).
English: • Excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of diabetes)
Danish: • Voldsom tørst, hyppig vandladning, øget appetit med vægttab, træthed (tegn på sukkersyge)
English: Includes all reactions within the ‘infections and infestations' system organ class including (common) pneumonia, urinary tract infection; (uncommon) bronchitis, herpes zoster, sepsis, abscess, and isolated cases of opportunistic infections [e.g. aspergillosis, candidiasis, PJP/PCP and hepatitis B (see also section 4.4)] and (rare) viral myocarditis b
Danish: Inklusive alle tilfælde inden for systemorganklassen “infektioner og parasitære sygdomme” inklusive (almindelig) pneumoni, urinvejsinfektion; (ikke almindelig) bronkitis, herpes zoster, sepsis, abscesser og isolerede tilfælde af opportunistiske infektioner [fx aspergillose, candidiasis, PJP/PCP og hepatitis B (se også pkt.
English: Renal impairment No dose adjustment is required (see section 5.2).
Danish: Der er ikke behov for dosisjustering (se pkt.
English: • Severely decreased urine output (sign of kidney failure)
Danish: • Stærkt nedsat vandladning (tegn på nyresvigt)
English: Clinical benefit rate c
Danish: Rate for klinisk fordel c n/a d e a
English: The median duration of blinded study treatment was 141 days (range 19-451 days) for patients receiving everolimus and 60 days (range 21-295 days) for those receiving placebo.
Danish: Den mediane varighed af blindet forsøgsbehandling var 141 dage (interval 19-451 dage) for patienter, der fik everolimus, og 60 dage (interval 21-295 dage) for dem, der fik placebo.
English: • Thirst, low urine output, dark urine, dry flushed skin, irritability (signs of dehydration)
Danish: • Tørst, nedsat vandladning, mørk urin, tør, rød hud, irritabilitet (tegn på væskemangel)
English: CYP3A4 and PgP inhibitors increasing everolimus concentrations Substances that are inhibitors of CYP3A4 or PgP may increase everolimus blood concentrations by decreasing metabolism or the efflux of everolimus from intestinal cells.
Danish: CYP3A4- og PgP-hæmmeres øgning af everolimus-koncentrationer Stoffer, der hæmmer CYP3A4 eller PgP, kan øge blodkoncentrationer af everolimus ved at nedsætte metabolismen eller effluksen af everolimus fra tarmcellerne.
English: Monitoring of fasting serum glucose is recommended prior to the start of Afinitor therapy and periodically thereafter.
Danish: Det anbefales at monitorere faste-serum-glucose før opstart af behandling med Afinitor og periodisk derefter.
English: • Swelling of the face, around the eyes, mouth, and inside the mouth and/or throat, as well as the tongue and difficulty breathing or swallowing (also known as angioedema), may be signs of an allergic reaction
Danish: • Hævelse i ansigtet, rundt om øjnene, munden og inden i munden og/eller halsen samt tungen med vejrtrækningsbesvær eller synkebesvær (også kendt som angioødem).
English: • Inflammation of the inner lining of the mouth, stomach, gut
Danish: • Betændelse i slimhinden i munden, maven eller tarmene
English: CYP3A4 and PgP inducers decreasing everolimus concentrations Substances that are inducers of CYP3A4 or PgP may decrease everolimus blood concentrations by increasing metabolism or the efflux of everolimus from intestinal cells.
Danish: CYP3A4- og PgP-induktorers nedsættelse af everolimus-koncentrationer Stoffer, der inducerer CYP3A4 eller PgP, kan nedsætte blodkoncentrationer af everolimus ved at øge metabolismen eller effluks af everolimus ud af tarmcellerne.
English: n/a d e
Danish: Ikke relevant e
English: They are engraved with “5” on one side and “NVR” on the other.
Danish: De er præget med “5” på den ene side og “NVR” på den anden.
English: • Heartburn (dyspepsia)
Danish: • Halsbrand (dyspepsi)
English: Everolimus + BSC (n/N = 113/205) Placebo + BSC (n/N = 65/97)
Danish: Censoreringstidspunkter Everolimus + BSC (n/N = 113/205) Placebo + BSC (n/N = 65/97)