FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in the placebo arm did not cross-over to everolimus at the time of progression.
Danish: Patienter i placebo-armen overgik ikke til everolimus på tidspunktet for progression.
English: The result of the final PFS analysis with 154 PFS events observed based on local investigator assessment showed an estimated HR of 0.74 (90% CI: 0.57, 0.97) in favour of the everolimus + exemestane arm relative to everolimus arm.
Danish: Resultatet af den endelige PFS-analyse med 154 hændelser, observeret baseret på lokal investigator-vurdering, viste en estimeret HR på 0,74 (90 % CI: 0,57; 0,97) til fordel for everolimus + exemestan-armen i forhold til everolimus-armen.
English: The key secondary objective was to estimate the HR of PFS for everolimus + exemestane versus capecitabine.
Danish: Det vigtigste sekundære formål var at estimere HR for PFS for everolimus + exemestan versus capecitabin.
English: Neuroendocrine tumours of pancreatic origin
Danish: Neuroendokrine tumorer udgået fra pancreas
English: Caution should be exercised when Afinitor is taken in combination with orally administered CYP3A4 substrates with a narrow therapeutic index due to the potential for drug interactions.
Danish: Der skal udvises forsigtighed, når Afinitor tages i kombination med oralt administrerede CYP3A4-substrater med et snævert terapeutisk vindue på grund af risiko for lægemiddelinteraktioner.
English: Afinitor may increase the risk of problems with wound healing.
Danish: Afinitor kan øge risikoen for problemer med sårheling.
English: Afinitor is used to treat adult patients with: hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments (so called “non-steroidal aromatase inhibitors”) no longer keep the disease under control.
Danish: Afinitor anvendes til behandling af voksne patienter med: - fremskreden hormonreceptorpositiv brystkræft hos postmenopausale kvinder, hvor andre behandlinger (såkaldte "ikke-steoide aromatasehæmmere") ikke længere er i stand til at holde sygdommen under kontrol.
English: For all analysed subgroups (age, sensitivity to prior hormonal therapy, number of organs involved, status of bone-only lesions at baseline and presence of visceral metastasis, and across major demographic and prognostic subgroups) a positive treatment effect was seen with everolimus + exemestane with an estimated hazard ratio (HR) versus placebo + exemestane ranging from 0.25 to 0.60.
Danish: For alle analyserede undergrupper (alder, sensitivitet for tidligere hormonbehandling, antallet af involverede organer, status for læsioner i knogler alene ved baseline og tilstedeværelse af visceral metastase samt på tværs af store demografiske og prognostiske undergrupper) sås en positiv behandlingsvirkning med everolimus + exemestan med en estimeret risiko-ratio (HR) versus placebo + exemestan på mellem 0,25 og 0,60.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE10
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, andre antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE10
English: Number of Patients still at Risk
Danish: Antal patienter stadig i risiko
English: Patients in the placebo + exemestane arm did not cross over to everolimus at the time of progression.
Danish: Patienter i placebo + exemestan-armen overgik ikke til everolimus på progressiontidspunktet.
English: Afinitor could harm your breast-fed baby.
Danish: Afinitor kan skade dit ammede barn.
English: What you need to know before you take Afinitor
Danish: Det skal du vide, før du begynder at tage Afinitor
English: Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus.
Danish: Non-infektiøs pneumonitis er en klasseeffekt af rapamycinderivater inklusive everolimus.
English: Common Aspartate aminotransferase increased, alanine aminotransferase increased Skin and subcutaneous tissue disorders
Danish: Almindelig Forhøjet aspartataminotransferase, forhøjet alaninaminotransferase Hud og subkutane væv
English: Hyperglycaemia has been reported (see section 4.8).
Danish: Hyperglykæmi er rapporteret (se pkt.
English: If you have taken too much Afinitor, or if someone else accidentally takes your tablets, see a doctor or go to a hospital immediately.
Danish: Hvis du har taget for mange Afinitor-tabletter Hvis du har taget for mange Afinitor-tabletter, eller hvis andre ved et uheld har taget dine tabletter, skal du straks tage til lægen eller på hospitalet.
English: • Swelling of arms, hands, feet, ankles or other part of the body (signs of oedema)
Danish: • Hævelse af arme, hænder, fødder, ankler eller andre dele af kroppen (tegn på vand i kroppen)
English: Management of severe and/or intolerable suspected adverse reactions may require dose reduction and/or temporary interruption of Afinitor therapy.
Danish: Ved svære og/eller uacceptable bivirkninger kan dosisreduktion og/eller midlertidig afbrydelse af behandlingen være påkrævet.
English: St John's Wort (Hypericum perforatum)
Danish: Perikon (Hypericum Perforatum)
English: Those randomised to placebo were then able to receive open-label Afinitor.
Danish: De patienter, som var randomiseret til at få placebo, kunne derefter få open-label Afinitor.
English: Concomitant treatment with potent CYP3A4 inhibitors result in dramatically increased plasma concentrations of everolimus (see section 4.5).
Danish: Samtidig behandling med potente CYP3A4-hæmmere resulterer i dramatisk øgede plasmakoncentrationer af everolimus (se pkt.
English: Hazard ratio (95% CI) from stratified Cox model
Danish: Risikorate (95 % CI) fra stratificeret Cox-model
English: An interaction study in healthy subjects demonstrated that co-administration of an oral dose of midazolam, a sensitive CYP3A substrate probe, with everolimus resulted in a 25% increase in midazolam Cmax and a 30% increase in midazolam AUC(0-inf).
Danish: Et interaktionsstudie med raske forsøgspersoner viste, at samtidig administration af en oral dosis midazolam, et sensitivt CYP3A-testsubstrat, og everolimus resulterede i en stigning på 25% i Cmax og på 30% i AUC(0-inf) for midazolam.
English: Intermediate risk
Danish: Middel risiko
English: The safety, tolerability and pharmacokinetics of everolimus were evaluated in two single oral dose studies of Afinitor tablets in 8 and 34 subjects with impaired hepatic function relative to subjects with normal hepatic function.
Danish: Everolimus' sikkerhed, tolerabilitet og farmakokinetik blev vurderet i to enkeltdosisstudier med Afinitor-tabletter hos 8 og 34 personer med nedsat leverfunktion i forhold til personer med normal leverfunktion.
English: Some mouthwashes and gels can make ulcers worse, so do not try anything without checking with your doctor first.
Danish: Nogle mundskyllevæsker og geler kan gøre sår værre, så du skal tale med din læge, før at du starter på behandling.
English: Some of these infections have been severe (e.g. leading to sepsis, respiratory or hepatic failure) and occasionally fatal.
Danish: Nogle af disse infektioner har været alvorlige (har fx ført til sepsis, respirations- eller leversvigt), og i nogle tilfælde letale.
English: If Afinitor is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride, quinidine or ergot alkaloid derivatives), the patient should be monitored for undesirable effects described in the product information of the orally administered CYP3A4 substrate (see section 4.5).
Danish: Hvis Afinitor tages med orale CYP3A4-substrater med et snævert terapeutisk vindue (fx pimozid, terfenadin, astemizol, cisaprid, quinidin eller sekalealkaloider), skal patienten monitoreres for de bivirkninger, der er beskrevet i produktinformationen for det orale CYP3A4-substrat (se pkt.
English: Dyslipidaemia (including hypercholesterolaemia and hypertriglyceridaemia) has been reported.
Danish: Dyslipidæmi (inklusive hyperkolesterolæmi og hypertriglyceridæmi) er rapporteret.
English: Afinitor may increase blood sugar levels and worsen diabetes mellitus.
Danish: Afinitor kan øge mængden af sukker i blodet og forværre sukkersyge.
English: Demographics were well balanced (pooled median age [61 years; range 27-85], 78% male, 88% Caucasian, number of prior VEGFR-TKI therapies [1-74%, 2-26%]).
Danish: Demografien var velafbalanceret (poolet median-alder [61 år; fra 27 til 85], 78% mænd, 88% kaukasiere, antal tidligere VEGFR-TKI-behandlinger [1-74%, 2-26%]).
English: Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Afinitor (see section 4.8).
Danish: Stomatitis, herunder mundsår og oral mucositis, er den hyppigst rapporterede bivirkning hos patienter, der blev behandlet med Afinitor (se pkt.
English: • Swelling and/or pain in one of the legs, usually in the calf, redness or warm skin in the affected area (signs of blockade of a blood vessel (vein) in the legs caused by blood clotting)
Danish: • Hævelse eller/og smerter i ét af benene, ofte i læggen, rødme eller varm hud i det berørte område (tegn på blokering af en blodåre (vene) i benene pga. en blodprop)
English: • Abnormal results of renal blood tests (increased creatinine)
Danish: • Unormale resultater af blodprøver for nyrefunktionen (forhøjet kreatinin)
English: Blood and lymphatic system disorders Very common Anaemia
Danish: Blod og lymfesystem Meget almindelig
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 4 and Figure 1).
Danish: Effektresultaterne for det primære endepunkt blev indhentet fra den endelige PFS-analyse (se tabel 4 og figur 1).
English: If you are taking other medicines at the same time as Afinitor, your doctor may need to change the dose of Afinitor or the other medicines.
Danish: Hvis du tager anden medicin samtidig med Afinitor, skal din læge måske ændre dosis af Afinitor eller den anden medicin.
English: In a randomised, double-blind, multi-centre trial in patients with functional carcinoid tumours, Afinitor plus depot octreotide was compared to placebo plus depot octreotide.
Danish: I et randomiseret, dobbeltblindet multicenterstudie med patienter med funktionelle karcinoide tumorer blev Afinitor plus depotformulering af octreotid sammenlignet med placebo plus depotformulering af octreotid.
English: Functional carcinoid tumours
Danish: Funktionelle karcinoide tumorer
English: • Abnormal results of liver blood tests (increased alanine and aspartate aminotransferase)
Danish: • Unormale resultater af blodprøver for leverfunktionen (forhøjet alanin- og aspartat-aminotransferase)
English: Based on the results of the two studies, dose adjustment is recommended for patients with hepatic impairment (see sections 4.2 and 4.4).
Danish: Baseret på resultaterne fra de to studier anbefales det at justere dosis hos patienter med nedsat leverfunktion (se pkt.
English: In supportive analyses, positive treatment effect has been observed in all subgroups with the exception of the subgroup of patients with ileum as primary site of tumour origin (Ileum: HR=1.22 [95% CI: 0.56 to 2.65]; Non-ileum: HR=0.34 [95% CI: 0.22 to 0.54]; Lung: HR=0.43 [95% CI: 0.24 to 0.79]) (see Figure 5).
Danish: I understøttende analyser er der observeret positiv behandlingseffekt i alle undergrupper med undtagelse af undergruppen af patienter med primærtumor udgået fra ileum (ileum: HR=1,22 [95 % CI: 0,56-2,65]; ikke-ileum: HR=0,34 [95 % CI: 0,22-0,54]; lunge: HR=0,43 [95 % CI: 0,24-0,79]) (se figur 5).
English: Everolimus has immunosuppressive properties and may predispose patients to bacterial, fungal, viral or protozoan infections, including infections with opportunistic pathogens (see section 4.8).
Danish: Everolimus har immunsuppressive egenskaber og kan prædisponere patienter for infektioner forårsaget af bakterier, svampe, vira eller protozoer, inklusive infektioner med opportunistiske patogener (se pkt.
English: dexamethasone, a corticosteroid used to treat a wide variety of conditions including inflammatory or immune problems.
Danish: dexamethason, et kortikosteroid, som bruges til behandling af en lang række tilstande, blandt andet forskellige betændelseslignende reaktioner og problemer med immunforsvaret.
English: Grade 4 Discontinue treatment.
Danish: Grad 4 Seponer behandlingen.
English: Everolimus 10 mg + exemestane: 7.82 months Placebo + exemestane: 3.19 months
Danish: Everolimus 10 mg + exemestan: 7,82 måneder Placebo + exemestan: 3,19 måneder
English: Table 6 RADIANT-4 - Progression-free survival results
Danish: Table 6 RADIANT-4 - Resultater for progressionsfri overlevelse
English: • Sudden onset of shortness of breath, chest pain or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more arteries in your lungs become blocked)
Danish: • Pludseligt opstået åndenød, brystsmerter eller ophostning af blod (kan være tegn på en blodprop i lungerne, en tilstand, der opstår, når en eller flere af arterierne i dine lunger tilstoppes)
English: Supportive PFS analysis was based on local investigator review.
Danish: Understøttende PFS-analyser var baseret på den lokale investigators vurdering.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Afinitor in all subsets of the paediatric population in neuroendocrine tumours of pancreatic origin, thoracic neuroendocrine tumours and in renal cell carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Afinitor i alle undergrupper af den pædiatriske population med neuroendokrine tumorer udgået fra pancreas, neuroendokrine tumorer i thorax og ved renalcellekarcinom (se pkt.
English: Cases of PJP/PCP, some with fatal outcome, have been reported in patients who received everolimus.
Danish: Der er rapporteret tilfælde af PJP/PCP med letal udgang hos patienter, der fik behandling med everolimus.
English: If patients require co-administration of a moderate CYP3A4 or PgP inhibitor, dose reduction to 5 mg daily or 2.5 mg daily may be considered.
Danish: Hvis patienter har brug for samtidig administration af en moderat hæmmer af CYP3A4 eller PgP, kan det overvejes at reducere dosis til 5 mg eller 2,5 mg daglig.
English: The major target organs were male and female reproductive systems (testicular tubular degeneration, reduced sperm content in epididymides and uterine atrophy) in several species; lungs (increased alveolar macrophages) in rats and mice; pancreas (degranulation and vacuolation of exocrine cells in monkeys and minipigs, respectively, and degeneration of islet cells in monkeys), and eyes (lenticular anterior suture line opacities) in rats only.
Danish: De store målorganer var reproduktionsorganer hos begge køn (tubulær testikeldegeneration, reduceret mængde sædvæske i bitestikel og uterin atrofi) hos flere arter; og lunger (stigning i alveolære makrofager) hos rotter og mus; pancreas (degranulering og vakuolation af eksokrine celler i henholdsvis aber og minigrise samt degenerering af øceller i aber), og øjne (uklarheder ved lentikulare anteriore suturlinier) hos rotter alene.
English: The most common adverse reactions leading to discontinuation were pneumonitis (including interstitial lung disease), stomatitis, fatigue and dyspnoea.
Danish: De bivirkninger, som hyppigst medførte seponering, var pneumonitis (inklusiv interstitiel lungesygdom), stomatitis, træthed og dyspnø.
English: Non-infectious pneumonitis (including interstitial lung disease) has been frequently reported in patients taking Afinitor (see section 4.8).
Danish: Non-infektiøs pneumonitis (herunder interstitiel lungesygdom) har været rapporteret hyppigt hos patienter, der tog Afinitor (se pkt.
English: At the time of the final OS analysis, the median duration of everolimus treatment was 24.0 weeks (range 1.0-199.1 weeks).
Danish: På tidspunktet for den endelige OS-analyse var den mediane behandlingsvarighed med everolimus 24,0 uger (interval 1,0-199,1 uger).
English: Moderate hepatic impairment (Child-Pugh B) - the recommended dose is 5 mg daily.
Danish: Moderat nedsat leverfunktion (Child-Pugh B): Den anbefalede startdosis er 5 mg daglig.
English: Everolimus/Exemestane (n/N=80/104) Everolimus (n/N=74/103)
Danish: Censoreringstidspunkter Everolimus/Exemestan (n/N=80/104) Everolimus (n/N=74/103)
English: However, oral doses of everolimus in female rats at ≥0.1 mg/kg (approximately 4% of the AUC0-24h in patients receiving the 10 mg daily dose) resulted in increases in pre-implantation loss.
Danish: Orale doser af everolimus på ≥0,1 mg/kg (ca. 4 % af AUC0-24h hos patienter, der fik en dosis på 10 mg daglig) til hunrotter, resulterede dog i en stigning i præ-implantationstab.
English: Censoring Times Everolimus (n/N = 155/277) Placebo (n/N = 111/139)
Danish: Censureringstid Everolimus (n/N = 155/277) Placebo (n/N = 111/139)
English: The median duration of blinded treatment was 40.4 weeks for patients receiving Afinitor and 19.6 weeks for those receiving placebo.
Danish: Den mediane varighed af blindet forsøgsbehandling var 40,4 uger for patienter, der fik Afinitor, og 19,6 uger for dem, der fik placebo.
English: In a male fertility study in rats, testicular morphology was affected at 0.5 mg/kg and above, and sperm motility, sperm head count, and plasma testosterone levels were diminished at 5 mg/kg which caused a reduction in male fertility.
Danish: I et fertilitetsstudie med hanrotter påvirkedes testikelmorfologien ved 0,5 mg/kg og derover, og sædcellemotilitet, antal sædceller og plasmatestosteronniveau faldt ved 5 mg/kg, hvilket medførte et fald i fertilitet hos hanrotterne.
English: No clinical safety or efficacy data are currently available to support dose adjustment recommendations for the management of adverse reactions in patients with hepatic impairment.
Danish: På det nuværende tidspunkt er der ingen tilgængelige data vedrørende klinisk sikkerhed og effekt, som understøtter anbefaling af dosisjustering ved bivirkninger hos patienter med nedsat leverfunktion.
English: In a population pharmacokinetic analysis of 170 patients with advanced solid tumours, no significant influence of creatinine clearance (25-178 ml/min) was detected on CL/F of everolimus.
Danish: I en farmakokinetisk populationsanalyse af 170 patienter med progressive massive tumorer sås der ingen signifikant effekt af kreatininclearance (25-178 ml/min) på everolimus' CL/F.
English: Elevations of serum creatinine, usually mild, and proteinuria have been reported (see section 4.8).
Danish: Forhøjet serumkreatinin, som regel let forhøjet, og proteinuri er rapporteret (se pkt.
English: In healthy subjects, high fat meals reduced systemic exposure to everolimus 10 mg (as measured by AUC) by 22% and the peak plasma concentration Cmax by 54%.
Danish: Hos raske forsøgspersoner nedsatte måltider med højt fedtindhold eksponeringen for everolimus 10 mg (målt ved AUC) med 22% og peak-plasmakoncentrationen Cmax med 54%.
English: The other ingredients are butylhydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A and lactose anhydrous.
Danish: Øvrige indholdsstoffer: butylhydroxytoluen , magnesiumstearat, lactosemonohydrat, hypromellose, crospovidon type A og vandfri lactose.
English: A single-arm study in postmenopausal breast cancer patients treated with Afinitor plus exemestane suggested that an alcohol-free corticosteroid oral solution, administered as a mouthwash during the initial 8 weeks of treatment, may decrease the incidence and severity of stomatitis (see section 5.1).
Danish: Et enkeltarms-studie med postmenopausale brystkræftpatienter, der blev behandlet med Afinitor plus exemestan, tyder på, at en alkoholfri oral opløsning med kortikosteroid, administreret som mundskyllevæske i de første 8 ugers behandling, kan nedsætte forekomsten og alvorligheden af stomatitis (se pkt.
English: advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas.
Danish: - fremskredne tumorer (kræftknuder) kaldet neuroendokrine tumorer, som stammer fra maven, tarmene, lungerne eller bugspytkirtlen.
English: Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein or serum creatinine, is recommended prior to the start of Afinitor therapy and periodically thereafter.
Danish: Det anbefales at monitorere nyrefunktionen, herunder måling af blodureanitrogen (BUN), urinprotein eller serumkreatinin, inden opstart af behandling med Afinitor og med jævne mellemrum herefter.
English: If the moderate inhibitor is discontinued, consider a washout period of at least 2 to 3 days (average elimination time for most commonly used moderate inhibitors) before the Afinitor dose is returned to the dose used prior to initiation of the co-administration.
Danish: Hvis den moderate hæmmer seponeres, bør en udvaskningsperiode på mindst 2-3 dage (gennemsnitlig eliminationstid for de hyppigst anvendte moderate hæmmere) overvejes, før behandlingen fortsætter med den Afinitor-dosis, der blev anvendt før initiering af kombinationsbehandlingen.
English: Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
Danish: Afinitor er indiceret til behandling af inoperable eller metastaserende højt eller moderat differentierede neuroendokrine tumorer udgået fra pancreas hos voksne med progressiv sygdom.
English: Everolimus 10 mg + exemestane (n/N = 310/485) Placebo + exemestane (n/N = 200/239)
Danish: Everolimus 10 mg + exemestan (n/N = 310/485) Placebo + exemestan (n/N = 200/239)
English: The recommended dose is 10 mg everolimus once daily.
Danish: Den anbefalede dosis er 10 mg everolimus en gang dagligt.
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 6 and Figure 4).
Danish: Effektresultaterne for det primære endepunkt var baseret på den endelige PFS-analyse (se tabel 6 og figur 4).
English: In the second study of 34 subjects with different impaired hepatic function compared to normal subjects, there was a 1.6-fold, 3.3-fold and 3.6-fold increase in exposure (i.e. AUC0-inf) for subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, respectively.
Danish: I det andet studie med 34 personer med forskellige grader af nedsat leverfunktion, der blev sammenlignet med personer med normal leverfunktion, var der 1,6 gange, 3,3 gange og 3,6 gange øget eksponering (dvs. AUC0-uendelig) hos personer med henholdsvis let (Child-Pugh A), moderat (Child-Pugh B) og svært nedsat leverfunktion (Child-Pugh C).
English: • Dry skin, skin exfoliation, skin lesions
Danish: • Tør hud, skællende hud, skader på huden
English: If treatment with the inducer is discontinued, consider a washout period of at least 3 to 5 days (reasonable time for significant enzyme de-induction), before the Afinitor dose is returned to the dose used prior to initiation of the co-administration.
Danish: Hvis behandlingen med induktor seponeres, bør en udvaskningsperiode på mindst 3-5 dage (passende tid til ophør af signifikant udtalt enzyminduktion) overvejes, før behandlingen fortsætter med den Afinitor-dosis, der blev anvendt før initiering af kombinationsbehandlingen.
English: Re-initiate treatment at 5 mg daily.
Danish: Genoptag behandlingen med 5 mg daglig.
English: In patients with advanced solid tumours, peak everolimus concentrations (Cmax) are reached at a median time of 1 hour after daily administration of 5 and 10 mg everolimus under fasting conditions or with a light fat-free snack.
Danish: Hos patienter med progressive massive tumorer blev maksimum-koncentrationer (Cmax) af everolimus nået ved en mediantid på 1 time efter daglig administration af 5 og 10 mg everolimus fastende eller sammen med et let fedtfrit mellemmåltid.