FrancophonIA/ELRC3.0 huggingface dataset:
English: • Enzalutamide to treat prostate cancer.
Danish: • Enzalutamid til behandling af prostatakræft.
English: Data from a pharmacokinetic trial in subjects with varying degrees of renal function indicate that total palbociclib exposure (AUCinf) increased by 39%, 42%, and 31% with mild (60 mL/min≤CrCl<90 mL/min), moderate (30 mL/min≤CrCl <60 mL/min), and severe (CrCl <30 mL/min) renal impairment, respectively, relative to subjects with normal (CrCl ≥90 mL/min) renal function.
Danish: Data fra et farmakokinetisk studie med forsøgspersoner med varierende grader af nyrefunktion indikerer, at total palbociclib eksponering (AUCinf) forøgedes med henholdsvis 39 %, 42 % og 31 % ved let (60 ml/min<CrCl<90 ml/min), moderat (30 ml/min<CrCl<60 ml/min) og svært (CrCl<30 ml/min) nedsat nyrefunktion i forhold til forsøgspersoner med normal (CrCl<90 ml/min) nyrefunktion.
English: In the event of a palbociclib overdose, both gastrointestinal (e.g., nausea, vomiting) and haematological (e.g., neutropenia) toxicity may occur and general supportive care should be provided.
Danish: I tilfælde af overdosering af palbociclib kan der forekomme både gastrointestinal (fx kvalme, opkastning) og hæmatologisk toksicitet (fx neutropeni), og der bør gives generel understøttende behandling.
English: Palbociclib induced micronuclei via an aneugenic mechanism in Chinese Hamster Ovary cells in vitro and in the bone marrow of male rats at doses ≥100 mg/kg/day.
Danish: Via en aneugen mekanisme inducerede palbociclib mikronuklei i ovarieceller fra kinesiske hamstere in vitro og i knoglemarven hos hanrotter ved doser ≥ 100 mg/kg/dag.
English: Non-visceral Disease
Danish: Uden visceral sygdom
English: Hazard ratio (95% CI) and 1-sided p-value
Danish: Hazard ratio (95 % CI) og 1-sidet p-værdi
English: The dose of sensitive CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.
Danish: Dosis af følsomme CYP3A-substrater med et snævert terapeutisk indeks (f.eks. alfentanil, ciclosporin, dihydroergotamin, ergotamin, everolimus, fentanyl, pimozid, kinidin, sirolimus og tacrolimus) skal muligvis nedsættes ved samtidig administration af IBRANCE, eftersom IBRANCE kan øge deres eksponering.
English: Withhold IBRANCE until recovery to Grade ≤2 Resume at next lower dose.
Danish: Udsæt IBRANCE indtil bedring til grad ≤ 2 Genoptag med næste lavere dosis.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: • difficulty breathing or shortness of breath
Danish: • Åndenød eller stakåndethed
English: Compared to palbociclib given under overnight fasted conditions, the AUCinf and Cmax of palbociclib increased by 21% and 38% when given with high-fat food, by 12% and 27% when given with low-fat food, and by 13% and 24% when moderate-fat food was given 1 hour before and 2 hours after palbociclib dosing.
Danish: Palbociclib AUCinf og Cmax steg med 21 % og 38 %, når det blev givet med fedtholdig mad sammenlignet med, når palbociclib blev givet i fastende tilstand (over natten), med 12 % og 27 %, når det blev givet med fedtfattig mad, og med 13 % og 24 %, når mad med moderat fedtindhold blev givet 1 time før og 2 timer efter dosering af palbociclib.
English: Table 5 reports the laboratory abnormalities observed in pooled datasets from 3 randomised studies.
Danish: Skema 5 viser de laboratorieafvigelser, der blev observeret i puljede datasæt fra 3 randomiserede studier.
English: Palbociclib-related neoplastic finding in rats included an increased incidence of microglial cell tumours in the central nervous system of males at 30 mg/kg/day; there were no neoplastic findings in female rats at any dose up to 200 mg/kg/day.
Danish: Palbociclib-relaterede neoplastiske fund hos rotter omfattede en øget forekomst af mikroglialcelletumorer i det centrale nervesystem hos hanrotter ved 30 mg/kg/dag; der var ingen neoplastiske fund hos hunrotter ved enhver dosis på op til 200 mg/kg/dag.
English: The capsule length is 18.0 ± 0.3 mm.
Danish: Kapslens længde er 18,0 ± 0,3 mm.
English: In addition, based on a population pharmacokinetic analysis that included 183 patients with advanced cancer, where 40 patients had mild hepatic impairment based on National Cancer Institute (NCI) classification (total bilirubin ≤ Upper Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin >1.0 to 1.5 × ULN and any AST), mild hepatic impairment had no effect on the pharmacokinetics of palbociclib.
Danish: Herudover viste en populationsfarmakokinetisk analyse af 183 patienter med fremskreden kræft, hvoraf 40 patienter havde let nedsat leverfunktion baseret på National Cancer Institute (NCI)-klassificeringen (total-bilirubin ≤ øverste grænse for normal (ULN) og aspartat aminotransferase (ASAT) > ULN eller total-bilirubin > 1,0 til1,5 × (ULN) og enhver ASAT), at let nedsat leverfunktion ingen indvirkning har på palbociclibs farmakokinetik (PK).
English: Women of childbearing potential/Contraception
Danish: Kvinder i den fertile alder/prævention
English: Despite these male reproductive organ findings, there were no effects on mating or fertility in male rats at projected exposure levels 13 times human clinical exposure based on AUC.
Danish: Trods disse fund på forplantningsorganer hos hanrotter var der ingen påvirkning af parring eller fertilitet hos hanrotter ved forventede eksponeringsniveauer på 13 gange den kliniske humane eksponering baseret på AUC.
English: IBRANCE 75 mg, 100 mg, and 125 mg are available in blister packs of 21 or 63 hard capsules and in plastic bottles of 21 hard capsules.
Danish: Ibrance 75 mg, 100 mg og 125 mg fås i blisterpakninger med 21 eller 63 hårde kapsler og plastbeholder med 21 hårde kapsler.
English: Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).
Danish: Baseret på in vitro-data kan palbociclib hæmme genoptagelses-transportøren, organisk-kationtransportør OCT1 og derved muligvis øge eksponeringen for lægemidler, der er substrater for dette transportprotein (fx metformin).
English: The concomitant use of strong CYP3A inhibitors including, but not limited to: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole, and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4).
Danish: Samtidig brug af potente CYP3A-hæmmere, herunder, men ikke begrænset til clarithromycin, indinavir, itraconazol, ketoconazol, lopinavir/ritonavir, nefazodon, nelfinavir, posaconazol, saquinavir, telaprevir, telithromycin, voriconazol og grapefrugt eller grapefrugtjuice, bør undgås (se pkt.
English: The pharmacokinetics of palbociclib have not been studied in patients requiring haemodialysis.
Danish: Palbociclibs farmakokinetik er ikke blevet undersøgt hos patienter som har behov for hæmodialyse.
English: Therefore, administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g., pravastatin, rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions.
Danish: Derfor kan samtidig administration af palbociclib og lægemidler, som er substrater for P-gp (fx digoxin, dabigatran, colchicin) eller BCRP (fx pravastatin, rosuvastatin, sulfasalazin), medføre øget virkning og øgede bivirkninger af disse lægemidler.
English: Effect of tamoxifen on palbociclib exposure
Danish: Tamoxifens indvirkning på eksponeringen for palbociclib
English: Laboratory abnormalities observed in pooled dataset from 3 randomised studies (N=872)
Danish: Laboratorieafvigelser, der blev observet i puljede datasæt fra 3 randomiserede studier (N=872)
English: Efficacy results - PALOMA-3 study (investigator assessment, intent-to-treat population)
Danish: Skema 8 - Effektdata - PALOMA-3 (investigatorvurderet, intent-to-treat-population)
English: PAL=palbociclib; LET=letrozole; PCB=placebo.
Danish: PAL=palbociclib; LET=letrozol; PCB=placebo.
English: Final overall survival (OS) (13 April 2018 cutoff) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value†
Danish: Endelig samlet overlevelse (OS) (13. april 2018 som skæringsdato) Antal hændelser (%) Median [måneder (95 % CI)] Hazard ratio (95% CI) og p-værdi p=0,0429
English: The capsule length is 19.4 ± 0.3 mm.
Danish: Kapslens længde er 19,4 ± 0,3 mm.
English: The most common (≥2%) Grade ≥3 adverse reactions of palbociclib were neutropenia, leukopenia, infections, anaemia, aspartate aminotransferase (AST) increased, fatigue, and alanine aminotransferase (ALT) increased.
Danish: De hyppigste (≥ 2 %) bivirkninger grad ≥ 3 var neutropeni, leukopeni, infektioner, anæmi, forhøjet aspartataminotransferase (ASAT), træthed og forhøjet alaninaminotransferase (ALAT).
English: Adverse reactions based on pooled dataset from 3 randomised studies (N=872)
Danish: Bivirkninger baseret på puljede datasæt fra 3 randomiserede studier (N = 872) Systemorganklasse
English: Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA-3 study (23 October 2015 cutoff)
Danish: Kaplan-Meier-kurver over progressionsfri overlevelse (investigatorvurderet, intent-to-treat-population) - PALOMA-3 studiet (23. oktober 2015 som skæringsdato)
English: • Carbamazepine and phenytoin, used to stop seizures or fits.
Danish: • Carbamazepin og phenytoin, som anvendes til at stoppe krampeanfald.
English: Capsule shell: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Danish: Kapselskal: gelatine, rød jernoxid (E172), gul jernoxid (E172), titandioxid (E171).
English: Printing ink: shellac, titanium dioxide (E171), ammonium hydroxide (28% solution), propylene glycol, simeticone (see section 2 “IBRANCE contains lactose”).
Danish: Printblæk: shellak, titandioxid (E171), ammoniumhydroxid (28% opløsnig), propylenglycol, simeticon (se afsnit 2).
English: IBRANCE dose modification and management - Non-haematological toxicities CTCAE Grade
Danish: Anbefalet dosisjustering og håndtering af IBRANCE - Ikke-hæmatologiske bivirkninger CTCAE-grad
English: Therefore, men may consider sperm preservation before taking IBRANCE.
Danish: Mænd bør derfor overveje at få opbevaret sæd i en sædbank, inden de tager IBRANCE.
English: Similarly, a reduction in the risk of disease progression or death in the palbociclib plus letrozole arm was observed in 512 patients whose tumour tested positive for Rb protein expression by immunohistochemistry (IHC) (HR of 0.543 [95% CI: 0.433, 0.681], mPFS 27.4 months versus 13.7 months).
Danish: Der blev også observeret en reduktion i risiko for sygdomsprogression eller død i palbociclib plus letrozolarmen hos 512 patienter med tumor testet positiv for Rb-proteinekspression ved immunhistokemi (IHC) (HR 0,543 [95 % CI: 0,433; 0,681], mPFS 27,4 måneder versus 13,7 måneder).
English: The following medicines may have increased risk of side effects when given with IBRANCE:
Danish: Følgende lægemidler kan øge risikoen for bivirkninger, når de gives samtidig med IBRANCE:
English: The mean fraction unbound (fu) of palbociclib in human plasma in vivo increased incrementally with worsening hepatic function.
Danish: Den gennemsnitlige fraktion af ubundet (fu) palbociclib i humant plasma in vivo forøgedes i takt med forværret leverfunktion.
English: Data from a pharmacokinetic trial in subjects with varying degrees of hepatic function indicate that palbociclib unbound exposure (unbound AUCinf) decreased by 17% in subjects with mild hepatic impairment (Child-Pugh class A), and increased by 34% and 77% in subjects with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment, respectively, relative to subjects with normal hepatic function.
Danish: Data fra et farmakokinetisk studie med forsøgspersoner med varierende grader af leverfunktion indikerer, at eksponering for ubundet palbociclib (ubundet AUCinf) faldt med 17 % hos forsøgspersoner med let nedsat leverfunktion (Child-Pugh-klasse A) og forøgedes med henholdsvis 34 % og 77 % hos forsøgspersoner med moderat (Child-Pugh-klasse B) og svært (Child-Pugh-klasse C) nedsat leverfunktion sammenlignet med forsøgspersoner med normal leverfunktion.
English: Palbociclib did not affect mating or fertility in female rats at any dose tested up to 300 mg/kg/day (approximately 3 times human clinical exposure based on AUC), and no adverse effects were observed in female reproductive tissues in repeat-dose toxicity studies up to 300 mg/kg/day in the rat and 3 mg/kg/day in the dog (approximately 5 and 3 times human clinical exposure based on AUC, respectively).
Danish: Palbociclib påvirkede ikke parring eller fertilitet hos hunrotter uanset den testede dosis på op til 300 mg/kg/dag (ca. 3 gange den humane kliniske eksponering baseret på AUC), og der blev ikke observeret negative virkninger på hunlige forplantningsorganer i toksicitetsstudier med gentagen indgift på op til 300 mg/kg/dag hos hunrotter og 3 mg/kg/dag hos hunde (henholdsvis ca. 5 og 3 gange den humane kliniske eksponering baseret på AUC).
English: Data from a DDI study in healthy male subjects indicated that palbociclib exposures were comparable when a single dose of palbociclib was coadministered with multiple doses of tamoxifen and when palbociclib was given alone.
Danish: Data fra et lægemiddelinteraktionsstudie med raske mandlige forsøgspersoner viste, at eksponeringen for palbociclib var den samme, når en enkelt dosis palbociclib blev administreret samtidigt med flere doser tamoxifen, som når palbociclib blev administreret alene.
English: What you need to know before you take IBRANCE
Danish: Det skal du vide, før du begynder at tage IBRANCE
English: Coadministration of multiple doses of palbociclib with midazolam increased the midazolam AUCinf and Cmax values by 61% and 37%, respectively, as compared with administration of midazolam alone.
Danish: Administration af flere doser palbociclib sammen med midazolam øgede midazolam AUCinfog Cmax med henholdsvis 61 % og 37 % sammenlignet med administration af midazolam alene.
English: Absolute neutrophil counts (ANC) of ≥1000/mm3 and platelet counts of ≥50,000/mm3 are recommended to receive IBRANCE.
Danish: Inden administration af IBRANCE anbefales et absolut neutrofiltal (ANC) ≥ 1.000/mm og trombocyttal ≥ 50.000/mm3.
English: Shellac
Danish: Shellack
English: In addition, based on a population pharmacokinetic analysis that included 183 patients with advanced cancer, where 73 patients had mild renal impairment and 29 patients had moderate renal impairment, mild and moderate renal impairment had no effect on the pharmacokinetics of palbociclib.
Danish: Herudover viste en populationsfarmakokinetisk analyse af 183 patienter med fremskreden kræft, hvoraf 73 patienter havde let nedsat nyrefunktion og 29 patienter havde moderat nedsat nyrefunktion, at let og moderat nedsat nyrefunktion ingen indvirkning har på PK for palbociclib.
English: Hazard ratio [(95% CI) and p-value]
Danish: Hazard ratio ((95 % CI) og p-værdi)
English: A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy or on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to palbociclib plus fulvestrant or placebo plus fulvestrant and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Danish: I alt 521 præ-, peri- og postmenopausale kvinder, hvor sygdommen havde progredieret ved eller inden for 12 måneder efter afslutning af adjuverende endokrin terapi eller ved eller inden for 1 måned efter forudgående endokrin terapi for fremskreden sygdom, blev randomiseret i forholdet 2:1 til palbociclib plus fulvestrant eller placebo plus fulvestrant og stratificeret iht.
English: Progression-Free Survival by Investigator Assessment Number of events (%) Median PFS [months (95% CI)]
Danish: Progressionsfri overlevelese baseret på investigators vurdering Antal hændelser (%) Median PFS (måneder (95 % CI))
English: Palbociclib was negative for carcinogenicity in transgenic mice at doses up to 60 mg/kg/day (No Observed Effect Level [NOEL] approximately 11 times human clinical exposure based on AUC).
Danish: Palbociclib var ikke karcinogent hos transgene mus ved doser på op til 60 mg/kg/dag (No Observed Effect Level [NOEL], ca. 11 gange den kliniske humane eksponering baseret på AUC).
English: Table 4 reports the adverse reactions from the pooled dataset of 3 randomised studies.
Danish: Skema 4 viser bivirkningerne fra det puljede datasæt fra tre randomiserede studier.
English: Please refer to the Summary of Product Characteristics of fulvestrant.
Danish: Se produktresuméet for fulvestrant for yderligere oplysninger.
English: Treatment of pre/perimenopausal women with the combination of palbociclib plus an aromatase inhibitor should always be combined with an LHRH agonist (see section 4.4).
Danish: Behandling af præ- og perimenopausale kvinder med kombinationen palbociclib plus en aromatasehæmmer skal altid kombineres med en LHRH-agonist (se pkt.
English: In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patient.
Danish: Afbryd straks behandlingen med Ibrance hos patienter, der har nye eller forværrende symptomer og mistanke om ILS/pneumonitis, og vurder patienten.
English: Patients with advanced symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Danish: Patienter med fremskreden symptomatisk visceral spredning med risiko for livstruende komplikationer på kort sigt (herunder patienter med massive ukontrollerede effusioner (pleural, perikardial, peritoneal), pulmonal lymfangitis og mere end 50 % leverinvolvering) var ikke egnede til inklusion i studiet.
English: What IBRANCE contains - The active substance is palbociclib.
Danish: IBRANCE indeholder: - Aktivt stof: palbociclib.
English: This was evident for pre/perimenopausal women (HR of 0.46 [95% CI: 0.28, 0.75]) and postmenopausal women (HR of 0.52 [95% CI: 0.40, 0.66]) and patients with visceral site of metastatic disease (HR of 0.50 [95% CI: 0.38, 0.65]) and non-visceral site of metastatic disease (HR of 0.48 [95% CI: 0.33, 0.71]).
Danish: Dette var evident for præ-/perimenopausale kvinder (HR 0,46 [95 % CI: 0,28-0,75]) og postmenopausale kvinder (HR 0,52 [95 % CI: 0,40-0,66]) og patienter med visceral metastatisk sygdom (HR 0,50 [95 % CI: 0,38-0,65]) og patienter med ikke-visceral metastatisk sygdom (HR 0,48 [95 % CI: 0,33-0,71]).
English: The efficacy of palbociclib in combination with letrozole versus letrozole plus placebo was evaluated in an international, randomised, double-blind, placebo-controlled, parallel-group, multicentre study conducted in women with ER-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer who had not received prior systemic treatment for their advanced disease.
Danish: Virkningen af palbociclib i kombination med letrozol versus letrozol plus placebo blev evalueret i et internationalt, randomiseret, dobbeltblind, placebokontrolleret, multicenterstudie med parallelle grupper hos kvinder med ER-positiv, HER2-negativ lokalt fremskreden brystkræft, hvor kurativ resektion eller strålebehandling ikke var mulig, eller metastatisk brystkræft, som ikke forudgående havde fået systemisk behandling for deres fremskredne sygdom.
English: 63 hard capsules
Danish: 21 hårde kapsler
English: You should not breast-feed while taking IBRANCE.
Danish: Amning Du må ikke amme, mens du tager IBRANCE.
English: Drug-drug interaction between palbociclib and oral contraceptives
Danish: Interaktion mellem palbociclib og orale kontraceptiva
English: No dose adjustments are needed for mild and moderate CYP3A inhibitors.
Danish: Dosisjustering er ikke nødvendig ved svage og moderate CYP3A-hæmmere.
English: Efficacy results in visceral and non-visceral disease from PALOMA-3 study
Danish: Skema 9 - Effektdata ved visceral og ikke-visceral sygdom fra PALOMA-3 studiet (intent-totreat population) Visceral sygdom
English: - if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for palbociclib eller et af de øvrige indholdsstoffer i IBRANCE
English: Concomitant treatment with inhibitors or inducers of CYP3A4
Danish: Samtidig behandling med CYP3A4-hæmmere eller -induktorer
English: * Secondary endpoints results are based on confirmed and unconfirmed responses according to RECIST 1.1.
Danish: * Sekundære endepunktsresultater er baseret på bekræftet og ubekræftet respons iht.
English: Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Danish: Patienter med fremskreden/metastatisk symptomatisk visceral spredning, der på kort sigt havde risiko for livstruende komplikationer (herunder patienter med massive ukontrollerede effusioner (pleural, perikardial, peritoneal), pulmonal lymfangitis og mere end 50 % leverinvolvering) var ikke egnede til inklusion i studiet.
English: Effects of other medicinal products on the pharmacokinetics of palbociclib
Danish: Virkninger af andre lægemidler på palbociclibs farmakokinetik
English: Kaplan-Meier plot of overall survival (intent-to-treat population) - PALOMA-3 study (13 April 2018 cutoff)
Danish: Kaplan-Meier-kurver over samlet overlevelse (intent-to-treat-population)PALOMA-3 studiet (13. april 2018 som skæringsdato)
English: Reduced foetal body weights were observed at a maternally toxic dose of 300 mg/kg/day in rats (3 times human clinical exposure based on AUC), and an increased incidence of skeletal variations, including small phalanges in the forelimb was observed at a maternally toxic dose of 20 mg/kg/day in rabbits (4 times human clinical exposure based on AUC).
Danish: Der blev observeret reduceret fostervægt ved en toksisk dosis på 300 mg/kg/dag hos hunrotter (3 gange den kliniske eksponering baseret på AUC), og en øget forekomst af skeletvariationer, herunder de små falanges i forbenene, ved en toksisk dosis på 20 mg/kg/dag hos hunkaniner (4 gange den kliniske eksponering baseret på AUC).
English: However, in a follow-up study with fresh tumour samples, no relation between RB1 expression and tumour response was observed.
Danish: Der blev dog ikke observeret relation mellem Rb1-ekspression og tumorrespons i et follow-up studie med friske tumorprøver.