FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains lactose (found in milk or dairy products).
Danish: Lægemidlet indeholder lactose, som findes i mælk og mejeriprodukter.
English: If Grade 4 on Day 22, see Grade 4 dose modification guidelines below.
Danish: I tilfælde af grad 4 på dag 22, se retninglinjerne herunder for grad 4 dosisjustering.
English: Patient-reported symptoms were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and its Breast Cancer Module (EORTC QLQ-BR23).
Danish: Patientrapporterede symptomer blev vurderet ved hjælp af spørgeskema fra European Organisation for Research and Treatment of Cancer (EORTC) vedrørende livskvalitet (QLQ)-C30 og dets Breast Cancer Module (EORTC QLQ-BR23).
English: No dose adjustment is required.
Danish: Dosisjustering ikke nødvendig.
English: Secondary endpoints included OR, CBR, overall survival (OS), safety, and time-to-deterioration (TTD) in pain endpoint.
Danish: Sekundære endepunkter omfattede OR, CBR, samlet overlevelse (OS), sikkerhed og tid indtil forværring (TTD) for smerte-endepunktet.
English: * letrozole or fulvestrant
Danish: * letrozol eller fulvestrant
English: Tell your healthcare provider right away if you have any new or worsening symptoms including:
Danish: Fortæl det straks til lægen, hvis du oplever nye eller forværrende symptomer, herunder:
English: If Grade 3 on Day 15, continue IBRANCE at the current dose to complete cycle and repeat complete blood count on Day 22.
Danish: I tilfælde af grad 3 på dag 15, fortsæt med IBRANCE på det nuværende dosisniveau for at fuldføre forløbet, og gentag komplet blodtælling på dag 22.
English: Interstitial lung disease/pneumonitis
Danish: Interstitiel lungesygdom/pneumonitis
English: Similarly, no relation was observed when studying the response to palbociclib in in vivo models with patient-derived xenografts (PDX models).
Danish: Tilsvarende blev der ikke observeret nogen sammenhæng, når man undersøgte responset på palbociclib i in vivo modeller med xenografer fra patienter (PDXmodeller).
English: Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE when taken in combination with endocrine therapy.
Danish: Alvorlig, livstruende eller letal ILS og/eller pneumonitis kan forekomme hos patienter behandlet med IBRANCE, når det tages i kombination med endokrin behandling.
English: Available clinical data are reported in the clinical efficacy and safety section (see section
Danish: De tilgængelige kliniske data er beskrevet i afsnittet om klinisk virkning og sikkerhed (se pkt.
English: Women of childbearing potential or their partners
Danish: Kvinder i den fertile alder og deres partnere
English: OR* [% (95% CI)] OR* measurable disease [% (95% CI)] CBR* [% (95% CI)] N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; PFS=progression-free survival.
Danish: OR* (% (95 % CI)) OR* målbar sygdom (% (95 % CI)) CBR* (% (95 % CI)) N=antal patienter; CI=konfidensinterval; NE=ikke estimerbart; OR=objektiv respons; CBR=positiv klinisk respons (clinical benefit response); PFS=progressionsfri overlevelse.
English: Second dose reduction
Danish: Anden dosisnedsættelse
English: The results from the investigator-assessed PFS and final OS data from PALOMA-3 study are presented in Table 8.
Danish: Resultaterne fra investigatorvurderet PFS og endelige OS-data fra PALOMA-3-studiet vises i skema 8.
English: It is not known if IBRANCE is excreted in breast milk.
Danish: Det vides ikke om IBRANCE udskilles i modermælken.
English: • Cyclosporine, everolimus, tacrolimus, and sirolimus used in organ transplantation to prevent rejection.
Danish: • Ciclosporin, everolimus, tacrolimus og sirolimus, som anvendes ved organtransplantation for at forhindre afstødning.
English: The pharmacokinetics of palbociclib were characterised in patients with solid tumours including advanced breast cancer and in healthy volunteers.
Danish: Palbociclibs farmakokinetik blev karakteriseret hos patienter med solide tumorer herunder fremskreden brystkræft og hos raske frivillige.
English: Grading according to CTCAE 4.0.
Danish: CTCAE 4.0.
English: In each treatment arm the majority of patients were White, had documented sensitivity to prior hormonal therapy, and were postmenopausal.
Danish: Størstedelen af patienterne i begge behandlingsarme var hvide, havde dokumenteret følsomhed for forudgående hormonbehandling og var postmenopausale.
English: It is unknown whether palbociclib is excreted in human milk.
Danish: Det er ukendt, om palbociclib udskilles i human mælk.
English: Strong inhibitors of CYP3A4 may lead to increased toxicity (see section 4.5).
Danish: Potente CYP3A4-hæmmere kan medføre øget toksicitet (se pkt.
English: Updated analysis (23 October 2015 cutoff) IBRANCE plus fulvestrant (N=347)
Danish: Opdateret analyse (23. oktober 2015som skæringsdato) IBRANCE plus fulvestrant (N = 347)
English: The median time to first episode of any grade neutropenia was 15 days (12-700 days) and the median duration of Grade ≥3 neutropenia was 7 days across 3 randomised clinical studies.
Danish: Mediantiden til første episode af enhver grad af neutropeni var 15 dage (12-700 dage), og medianvarigheden af neutropeni grad ≥ 3 var 7 dage på tværs af 3 randomiserede kliniske studier.
English: Cyclin D1 and CDK4/6 are downstream of multiple signalling pathways which lead to cellular proliferation.
Danish: Cyclin D1 og CDK4/6 er downstream for flere signalveje, der fører til celleproliferation.
English: IBRANCE is used to treat patients with certain types of breast cancer (hormone receptor-positive, human epidermal growth factor receptor 2-negative) which have spread beyond the original tumour and/or to other organs.
Danish: IBRANCE bruges til at behandle patienter med visse former for brystkræft (hormon receptor-positiv, human epidermal vækstfaktor receptor 2-negativ), som har spredt sig ud over den oprindelige tumor og/eller til andre organer.
English: Day 1 of cycle:
Danish: Dag 1 i forløbet:
English: Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 9.
Danish: Yderligere effektmål (OR og TTR) vurderet i sub-grupper af patienter med eller uden visceral sygdom er vist i skema 9.
English: IBRANCE contains lactose
Danish: IBRANCE indeholder lactose
English: A more mature update of efficacy data is reported in Table 8.
Danish: En senere opdatering af effektdata er vist i skema 8.
English: Testing of palbociclib in a panel of molecularly profiled breast cancer cell lines revealed high activity against luminal breast cancers, particularly ER-positive breast cancers.
Danish: Testning af palbociclib i et panel af molekylært profilerede brystkræftcellelinjer viste en høj aktivitet på luminal brystkræft, især ER-positiv brystkræft.
English: *If further dose reduction below 75 mg/day is required, discontinue the treatment.
Danish: 75 mg/dag* *Hvis yderligere dosisnedsættelse til under 75 mg/dag er nødvendig, skal behandlingen seponeres.
English: The Kaplan-Meier curves for PFS based on the updated cutoff date of 31 May 2017 are displayed in Figure 1 below.
Danish: Kaplan-Meier-kurverne over PFS baseret på 31. maj 2017 som skæringsdato er vist i figur 1 herunder.
English: All patients had received prior systemic therapy and most patients in each treatment arm had received a previous chemotherapy regimen for their primary diagnosis.
Danish: Alle patienter havde fået forudgående systemisk behandling og de fleste patienter i begge behandlingsarme havde forudgående fået kemoterapi for deres primære diagnose.
English: No capsule should be ingested if it is broken, cracked, or otherwise not intact.
Danish: Kapslerne må ikke indtages, hvis de er knuste, revnede eller defekte på anden måde.
English: Grade 3 ANCb (<1000 to 500/mm3) + Fever ≥38.5 ºC and/or infection
Danish: Grad 3 ANC (< 1.000 til 500/mm + feber ≥ 38,5 ºC og/eller infektion
English: i ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA Query
Danish: i ILS/pneumonitis omfatter alle rapporterede foretrukne termer, der er en del af standardiseret
English: First dose reduction
Danish: Første dosisnedsættelse
English: Coadministration of CYP3A inducers may lead to decreased palbociclib exposure and consequently a risk for lack of efficacy.
Danish: Samtidig administration af CYP3A-induktorer kan medføre nedsat eksponering for palbociclib og dermed risiko for manglende virkning.
English: Complete blood count should be monitored prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated.
Danish: Komplet blodtælling skal udføres inden start af behandling med IBRANCE og i begyndelsen af hvert forløb samt på dag 15 i de første 2 forløb samt ved klinisk indikation.
English: Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Danish: Det anbefales at afbryde behandlingen, nedsætte dosis eller udsætte start af en cyklus hos patienter, som udvikler neutropeni af grad 3 eller 4.
English: In addition, food intake significantly reduced the intersubject and intrasubject variability of palbociclib exposure.
Danish: Derudover reducerede fødeindtagelse væsentligt den inter-individuelle og intra-individuelle variabiliteten af eksponeringen for palbociclib.
English: HDPE bottle with a PP closure containing 21 hard capsules.
Danish: Beholder af HDPE med et låg af PP indeholdende 21 hårde kapsler.
English: † 1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomisation.
Danish: 1-sidet p-værdi fra stratificeret log-rank test efter tilstedeværelse af viscerale metastaser og følsomhed for tidligere endokrinbehandling pr. randomisering.
English: Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported (see section 4.8).
Danish: Yderligere tilfælde af ILS/pneumonitis er observeret efter markedsføring, hvor dødsfald blev rapporteret (se pkt.
English: With repeated once daily administration, palbociclib accumulates with a median accumulation ratio of 2.4 (range 1.5-4.2).
Danish: Ved gentagen administration en gang dagligt akkumuleres palbociclib med en median akkumulationsratio på 2,4 (1,5-4,2).
English: However, IBRANCE may cause fatigue and patients should exercise caution when driving or using machines.
Danish: Palbociclib kan dog forårsage træthed, og patienter bør udvise forsigtighed ved kørsel af motorkøretøj eller betjening af maskiner.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE33.
Danish: Farmakoterapeutisk gruppe: Antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE33.
English: Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles.
Danish: Overvej dosisnedsættelse i tilfælde af længerevarende (> 1 uge) restitution fra neutropeni grad 3 eller tilbagevendende neutropeni grad 3 på dag 1 i efterfølgende behandlingsforløb.
English: In the dosing range of 25 mg to 225 mg, the area under the curve (AUC) and Cmax increase proportionally with dose in general.
Danish: I doseringsområdet fra 25 mg til 225 mg steg arealet under kurven (AUC) og Cmax generelt proportionalt med dosis.
English: Febrile neutropenia has been reported in 0.9% of patients receiving IBRANCE in combination with fulvestrant and in 1.7% of patients receiving palbociclib in combination with letrozole.
Danish: Febril neutropeni er blevet rapporteret hos 0,9 % af de patienter, som fik IBRANCE i kombination med fulvestrant, og hos 1,7 % af de patienter, der fik palbociclib i kombination med letrozol.
English: Patients should be monitored for signs and symptoms of infection and treated as medically appropriate (see section 4.2).
Danish: Patienterne skal monitoreres for symptomer på infektion og behandles på en hensigtsmæssig måde (se pkt.
English: Pre/perimenopausal women received the LHRH agonist goserelin.
Danish: Præ-/perimenopausale kvinder fik LHRH-agonisten goserelin.
English: • Pimozide used to treat schizophrenia and chronic psychosis.
Danish: • Pimozid, som anvendes til behandling af skizofreni og kronisk psykose.
English: Through inhibition of CDK4/6, palbociclib reduced cellular proliferation by blocking progression of the cell from G1 into S phase of the cell cycle.
Danish: Gennem hæmning af CDK4/6 reducerer palbociclib celleproliferation ved at blokere cellens progression fra G1-fasen til S-fasen i cellecyklussen.
English: Febrile neutropenia has been reported in about 2% of patients exposed to IBRANCE across the overall clinical programme.
Danish: Febril neutropeni blev rapporteret hos ca. 2 % af de patienter, som fik IBRANCE på tværs af det samlede kliniske program.
English: • Nefazodone used to treat depression.
Danish: • Nefazodon, som anvendes til behandling af depression.
English: In faeces, the sulfamic acid conjugate of palbociclib was the major drug-related component, accounting for 25.8% of the administered dose.
Danish: I fæces var sulfaminsyrekonjugatet af palbociclib den vigtigste lægemiddelrelaterede komponent og udgjorde for 25,8 % af den administrerede dosis.
English: The geometric mean apparent oral clearance (CL/F) of palbociclib was 63 L/h, and the mean plasma elimination half-life was 28.8 hours in patients with advanced breast cancer.
Danish: Den geometrisk gennemsnitlige tilsyneladende orale clearance (CL/F) af palbociclib var 63 l/time, og den gennemsnitlige plasma eliminationshalveringstid var 28,8 timer hos patienter med fremskreden brystkræft.
English: Patients receiving palbociclib should not breast feed.
Danish: Patienter, der får palbociclib, bør ikke amme.
English: Pharmacokinetics of palbociclib has not been evaluated in patients <18 years of age.
Danish: Pædiatrisk population Palbociclibs farmakokinetik er ikke blevet evalueret hos patienter < 18 år.
English: IBRANCE is an anticancer medicine containing the active substance palbociclib.
Danish: IBRANCE er et lægemiddel mod kræft, der indeholder det aktive stof palbociclib.
English: You should avoid becoming pregnant while taking IBRANCE.
Danish: Du skal undgå at blive gravid, mens du tager IBRANCE.
English: In the placebo plus fulvestrant arm, 15.5% of randomised patients received palbociclib and other CDK inhibitors as post progression subsequent treatments.
Danish: I placebo plus fulvestrant-armen fik 15,5 % af randomiserede patienter palbociclib og andre CDKhæmmere som efterfølgende behandlinger efter progression.
English: Based on these results, palbociclib should be taken with food (see section 4.2).
Danish: Baseret på disse resultater skal palbociclib tages med mad (se pkt.
English: The following medicines may reduce the effectiveness of IBRANCE:
Danish: Følgende lægemidler kan nedsætte virkningen af IBRANCE:
English: Food effect
Danish: Effekt af føde
English: Palbociclib should not be taken with grapefruit or grapefruit juice (see section 4.5).
Danish: Palbociclib må ikke tages med grapefrugt eller grapefrugtjuice (se pkt.
English: The exposure of animals at the no observed effect level for aneugenicity was approximately 7 times human clinical exposure based on AUC.
Danish: Eksponeringen hos dyr ved niveauet for ikke observeret effekt for at inducere aneuploidi var ca. 7 gange den humane kliniske eksponering baseret på AUC.
English: The recommended dose is 125 mg of IBRANCE taken once a day for 3 weeks followed by 1 week without taking IBRANCE.
Danish: Den anbefalede dosis af IBRANCE er 125 mg, en gang dagligt i 3 uger efterfulgt af 1 uge, hvor du ikke tager IBRANCE.
English: A total of 405 PFS events were observed; 245 events (55.2%) in the palbociclib plus letrozole arm and 160 (72.1%) in the comparator arm respectively.
Danish: Der observeredes i alt 405 PFS-hændelser; henholdsvis 245 hændelser (55,2 %) i palbociclib plus letrozol-armen og 160 (72,1 %) i komparatorarmen.
English: How to take IBRANCE 4.
Danish: Sådan skal du tage IBRANCE 4.
English: Comparator arms*
Danish: Komparatorarme*
English: No dose adjustment of IBRANCE is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min).
Danish: Dosisjustering af IBRANCE er ikke nødvendig hos patienter med let, moderat eller svært nedsat nyrefunktion (kreatinin-clearance [CrCl] ≥ 15 ml/min).
English: Randomised Phase 3 Study PALOMA-3: IBRANCE in combination with fulvestrant
Danish: Randomiseret fase 3-studie PALOMA-3: IBRANCE i kombination med fulvestrant
English: It should be taken with food, preferably a meal to ensure consistent palbociclib exposure (see section 5.2).
Danish: Det skal tages med mad og helst i forbindelse med et måltid for at sikre ensartet eksponering for palbociclib (se pkt.
English: The efficacy and safety of palbociclib have not been studied in patients with critical visceral disease (see section 5.1).
Danish: Palbociclibs virkning og sikkerhed er ikke blevet undersøgt hos patienter med kritisk alvorlig sygdom (se pkt.
English: When recovered to Grade ≤2, start the next cycle at the same dose.
Danish: Ved bedring til grad ≤ 2, start næste forløb på samme dosisniveau.
English: The mean absolute bioavailability of palbociclib after an oral 125 mg dose is 46%.
Danish: Palbociclibs gennemsnitlige, absolutte biotilgængelighed efter en oral dosis på 125 mg er 46 %.
English: Palbociclib is considered to have the potential to impair reproductive function and fertility in male humans based on nonclinical findings in rats and dogs.
Danish: Palbociclib anses for at have en potentiel negativ virkning på reproduktion og fertilitet hos mænd baseret på ikke-kliniske fund hos rotter og hunde.
English: Carcinogenicity
Danish: Karcinogenecitet
English: These findings were observed in rats and/or dogs at exposures  9 times or subtherapeutic compared to human clinical exposure based on AUC, respectively.
Danish: Disse fund blev observeret hos rotter og/eller hunde ved eksponeringer på henholdsvis  9 gange eller subterapeutisk niveau sammenlignet med human klinisk eksponering baseret på AUC.
English: In vitro, palbociclib is not an inhibitor of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, and 2D6, and is not an inducer of CYP1A2, 2B6, 2C8, and 3A4 at clinically relevant concentrations.
Danish: In vitro hæmmer palbociclib ikke CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19 og 2D6 og inducerer ikke CYP1A2, 2B6, 2C8 og 3A4 ved klinisk relevante koncentrationer.
English: The European Medicines Agency has waived the obligation to submit the results of studies with IBRANCE in all subsets of the paediatric population in the treatment of breast 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 IBRANCE i alle undergrupper af den pædiatriske population ved behandlingen af brystkræft (se pkt.
English: Withhold IBRANCE, until recovery to Grade ≤2, and repeat complete blood count monitoring within 1 week.
Danish: Udsæt IBRANCE, indtil bedring til grad ≤ 2, og gentag komplet blodtælling inden for 1 uge.
English: Food intake increased the palbociclib exposure in this small subset of the population, but did not alter palbociclib exposure in the rest of the population to a clinically relevant extent.
Danish: Eksponeringen for palbociclib steg ved fødeindtagelse i en lille undergruppe af populationen, men ændrede ikke eksponeringen for palbociclib i resten af populationen i et klinisk relevant omfang.
English: Laboratory abnormalities
Danish: Laboratorieabnormiteter
English: • Voriconazole, itraconazole, ketoconazole, and posaconazole used to treat fungal infections.
Danish: • Voriconazol, itraconazol, ketoconazol og posaconazol, som anvendes til behandling af svampeinfektioner.
English: Based on male reproductive organ findings (seminiferous tubule degeneration in testis, epididymal hypospermia, lower sperm motility and density, and decreased prostate secretion) in nonclinical safety studies, male fertility may be compromised by treatment with palbociclib (see section 5.3).
Danish: Baseret på fund i hanlige reproduktionsorganer (degeneration af tubuli seminiferi i testes, epidymal hypospermi, nedsat spermmotilitet og -tæthed og nedsat prostatasekretion) i ikke-kliniske sikkerhedsstudier, kan mandlig fertilitet blive kompromitteret ved behandling med palbociclib (se pkt.
English: Interstitial Lung Disease (narrow).
Danish: MedDRA Query Interstitial Lung Disease (smal).
English: Palbociclib may decrease fertility in men.
Danish: Frugtbarhed Palbociclib kan nedsætte fertiliteten hos mænd.
English: 100 mg/day
Danish: 100 mg/dag
English: Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3, and no Grade 4 or fatal cases were reported.
Danish: På tværs af de kliniske studier (PALOMA-1, PALOMA-2, PALOMA-3) havde 1,4 % af patienter behandlet med IBRANCE ILS/pneumonitis af enhver grad, 0,1 % havde grad 3.
English: For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, complete blood counts for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated.
Danish: Hos patienter, som får neutropeni af højst grad 1 eller 2 i de første 6 forløb, kan monitoreringen af komplet blodtælling nedsættes til hver 3. måned og foretages inden start af et forløb samt ved klinisk indikation.
English: Additional efficacy measures (OR and time to response [TTR]) assessed in the sub-groups of patients with or without visceral disease based on the 31-May-2017 updated cutoff date are displayed in Table 7.
Danish: Yderligere effektmål (objektiv respons (OR) og tid til første respons (TTR)) vurderet i sub-grupper af patienter med eller uden visceral sygdom, baseret på den opdaterede skæringsdato for data 31. maj 2017, er vist i skema 7.
English: Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea).
Danish: Monitorer patienter for lungesymptomer, der tyder på ILS/pneumonitis (f.eks. hypoxi, hoste, dyspnø).
English: Palbociclib did not prolong the QTc to any clinically relevant extent at the recommended dose of 125 mg daily (Schedule 3/1).
Danish: Palbociclib forlængede ikke QTc i klinisk relevant grad ved den rekommanderede dosis på 125 mg dagligt (doseringsplan 3/1).
English: If you stop taking IBRANCE
Danish: Hvis du holder op med at tage IBRANCE
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them: Contact your doctor immediately if you have any of these symptoms:
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Dose reductions or dose modifications due to any adverse reaction occurred in 38.4% of patients receiving IBRANCE in randomised clinical studies regardless of the combination.
Danish: Dosisnedsættelse eller doseringsændringer på grund af bivirkninger forekom hos 38,4 % af patienter, som fik IBRANCE i randomiserede kliniske studier, uafhængigt af kombinationen.
English: IBRANCE is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: IBRANCE bør ikke anvendes under graviditet ellertil kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: A total of 335 patients in the palbociclib plus fulvestrant arm and 166 patients in the fulvestrant only arm completed the questionnaire at baseline and at least 1 postbaseline visit.
Danish: Ialt 335 patienter i palbociclib plus fulvestrant-armen og 166 patienter i placebo pluse fulvestrant-armen udfyldte spørgeskemaet ved baseline og ved mindst et efterfølgende besøg.
English: Randomised Phase 3 Study PALOMA-2: IBRANCE in combination with letrozole
Danish: Randomiseret fase 3-studie PALOMA-2: IBRANCE i kombination med letrozol