FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer før og under markedsføringen af lægemidlet.
English: Lasofoxifene has been associated with benign endometrial effects.
Danish: Lasofoxifen har været forbundet med benigne endometrielle påvirkninger.
English: Less than 2% of the administered dose was recovered in the urine as unchanged lasofoxifene.
Danish: Mindre end 2 % af den administrerede dosis blev genfundet i urinen som uomdannet lasofoxifen.
English: Since FABLYN is indicated for use only in postmenopausal women, no assessment of the effect of gender on lasofoxifene pharmacokinetics has been made.
Danish: Da Fablyn udelukkende er indiceret til brug hos postmenopausale kvinder, er der ikke foretaget nogen vurdering af effekten af køn på lasofoxifens farmakokinetik.
English: Pharmacokinetic data from over 2,000 postmenopausal women including patients in selected osteoporosis clinical trials contributed to a population pharmacokinetic analysis.
Danish: Farmakokinetiske data fra mere end 2000 postmenopausale kvinder, inklusive patienter i udvalgte osteoporose-studier, har dannet grundlag for en populationsfarmakokinetisk analyse.
English: • Printed on paper
Danish: • På papir
English: Other venous thromboembolic events could also occur.
Danish: Der sås også andre venøse tromboemboliske hændelser.
English: • FABLYN increases risk of venous thromboembolism (VTE).
Danish: • FABLYN øger risikoen for venøs tromboemboli (VTE).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Sealed pack.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Forseglet pakning.
English: Lasofoxifene was not genotoxic in any of the battery of tests applied.
Danish: Lasofoxifen var ikke genotoksisk i nogen af de omfattende tests, som blev benyttet.
English: Therefore FABLYN is unlikely to alter the pharmacokinetics of medicinal products that are cleared by metabolism via these CYP isoforms, or are transported by MDR1 P-glycoprotein.
Danish: Det er derfor usandsynligt, at Fablyn ændrer farmakokinetikken af lægemidler, der metaboliseres via disse CYPisoformer eller transporteres af MDR1 P-glycoprotein.
English: The recommended dose is one 500 microgram tablet daily.
Danish: Den anbefalede dosis er en tablet på 500 µg dagligt.
English: The suppression of bone turnover markers was evident by 3 months and persisted throughout the 36-month observation period in a sub-study of the PEARL study.
Danish: Hæmningen af knogleomsætningsmarkørerne kunne påvises efter 3 måneder og blev fastholdt gennem en observationsperiode på 36 måneder i et substudie under PEARL-studiet.
English: Lasofoxifene has a half-life of approximately 6 days.
Danish: Lasofoxifen har en halveringstid på ca. 6 dage.
English: • Painful urination, blood in urine
Danish: • Smerter ved vandladning, blod i urinen
English: In both studies, it decreased the severity of the subject's most bothersome baseline VVA symptom, decreased vaginal pH, decreased the percentage of vaginal parabasal cells from the maturation index (MI) and increased the percentage of vaginal superficial cells from the MI.
Danish: I begge studier nedsatte behandlingen sværhedsgraden af patienternes mest generende baseline VVA-symptom, nedsatte vaginalt pH, nedsatte procentdelen af vaginale parabasale celler fra maturation index (MI) og øgede procentdelen af vaginale overfladeceller fra MI.
English: The recommended intake of vitamin D is 400-800 IU daily.
Danish: Det anbefalede daglige indtag af vitamin D er 400-800 IU.
English: Significant increases in BMD were observed as early as 3 months for lumbar spine and total hip.
Danish: Signifikante stigninger i BMD blev set så tidligt som efter 3 måneder for lænderygsøjle og total hofte.
English: Skeletal effects:
Danish: Skeletale virkninger:
English: Therefore, FABLYN should be used for the treatment of osteoporosis only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Danish: Derfor bør Fablyn kun bruges til behandling af osteoporose, efter at behandlingen for mammacancer, herunder adjuverende behandling, er afsluttet.
English: • Pressure in the lower abdomen
Danish: • Trykken i den nedre del af maven
English: Bone formed during two years' administration of lasofoxifene is of normal quality.
Danish: Knoglevæv, der nydannes gennem to år under behandling med lasofoxifen, er af normal kvalitet.
English: These observations support the conclusion that lasofoxifene has no intrinsic estrogen agonist activity in breast tissue.
Danish: Disse observationer støtter konklusionen, at lasofoxifen ikke har nogen egen østrogenagonistisk aktivitet i brystvæv.
English: The effect of FABLYN on the lipid profile was evaluated in a 3-year substudy of the PEARL study; the substudy enrolled 1,014 postmenopausal women.
Danish: Fablyns virkning på lipidprofilen blev undersøgt i et 3-års substudie under PEARL-studiet; substudiet involverede 1014 postmenopausale kvinder.
English: Most of the side effects that occurred during studies were mild.
Danish: De fleste bivirkninger, som er set, var milde.
English: ** Endometrial hyperplasia events based on investigator reporting rather than histopathology findings and did not require histological confirmation.
Danish: ** Endometriehyperplasi-hændelser baseret på indrapporteringer fra investigatorer uden histopatologi og uden histologisk verifikation.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: The incidence of endometrial cystic change and endometrial thickness was analyzed in a subset of the study population (298 patients) with an annual transvaginal ultrasound (TVU) through 3 years.
Danish: Forekomsten af cystiske endometrieforandringer og endometrietykkelse blev undersøgt hos en undergruppe af studiepopulationen (298 patienter) ved en årlig transvaginal ultralydsundersøgelse (TVU) gennem 3 år.
English: • FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Danish: • FABLYN medfører morfologiske forandringer, især cystisk atrofi i endometriet.
English: The following results of the effects of FABLYN on the endometrium through 5 years of exposure are reported from the PEARL study.
Danish: Følgende information om Fablyns virkning på endometriet gennem 5 års eksponering kommer fra PEARL-studiet.
English: In a population pharmacokinetic analysis, there were no clinically meaningful differences in lasofoxifene pharmacokinetics between postmenopausal women with estimated creatinine clearance as low as 32 ml/min and those with normal creatinine clearance.
Danish: I en populationsfarmakokinetisk analyse ses der ingen klinisk relevante forskelle i lasofoxifens farmakokinetik mellem postmenopausale kvinder med estimeret creatininclearance så lav som 32 ml/min og kvinder med normal creatininclearance.
English: So any vaginal bleeding while you take FABLYN is unexpected.
Danish: Så enhver blødning fra skeden, mens De tager FABLYN, er derfor unormal.
English: In some women, these changes will eventually lead to decreased bone mass, osteoporosis, and increased risk for fractures, particularly of the spine, hip, and wrist.
Danish: Hos nogle kvinder vil disse ændringer i sidste instans føre til nedsat knoglemasse, osteoporose og øget risiko for frakturer, særligt af rygsøjle, hofte og håndled.
English: The efficacy of FABLYN in the treatment of VVA was investigated in two 12-week Phase 3 studies in postmenopausal women with moderate or severe signs and symptoms of VVA, regardless of osteoporosis status (involving 889 patients).
Danish: Fablyns virkning i behandlingen af VVA blev undersøgt i to 12-ugers fase 3-studier med postmenopausale kvinder med moderate eller alvorlige tegn og symptomer på VVA, uafhængigt af osteoporose-status (889 patienter).
English: The safety of FABLYN in the treatment of osteoporosis was assessed in a large (8,556 patients) double-blind, randomized, placebo-controlled multinational Phase 3 fracture trial (the PEARL study).
Danish: Sikkerheden af Fablyn ved osteoporosebehandling blev vurderet i et stort (8556 patienter) dobbeltblindt, randomiseret, placebokontrolleret multinationalt fase 3-fraktur-studie (PEARL-studiet).
English: The increased turnover causes accelerated bone loss because the compensatory increase in bone formation is not sufficient to offset increased bone resorption.
Danish: Den øgede omsætning medfører accelereret knogletab, da den kompensatoriske øgning i knogledannelsen ikke er tilstrækkelig til at opveje den øgede knogleresorption.
English: Animal studies have shown excretion of lasofoxifene in milk.
Danish: Dyreforsøg har vist udskillelse af lasofoxifen i mælk.
English: • The active substance is lasofoxifene.
Danish: • Aktivt stof: lasofoxifen.
English: Because immobilization increases the risk for venous thromboembolic events independent of therapy, FABLYN should be discontinued at least 3 weeks prior to and during prolonged immobilization (e.g., post-surgical recovery, prolonged bed rest), and therapy should be resumed only after the patient is fully ambulatory.
Danish: Da immobilisering i sig selv øger risikoen for venøse tromboemboliske hændelser, bør Fablyn seponeres mindst 3 uger før og under langvarig immobilisering (f.eks. post-operativ hvile, forlænget sengeleje), og behandlingen bør først genoptages, når patienten er fuldt oppegående.
English: FABLYN contains lactose.
Danish: Fablyn indeholder lactose.
English: Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Germany.
Danish: Indehaver af markedsføringstilladelsen er: Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Tyskland.
English: The study population consisted of 497 women with osteoporosis as defined by low vertebral BMD (T-score ≤ 2.5).
Danish: Studiepopulationen bestod af 497 kvinder med osteoporose, defineret ved lav rygsøjle-BMD (Tscore ≤ 2,5).
English: FABLYN is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Danish: Fablyn er indiceret til behandling af osteoporose hos postmenopausale kvinder med øget risiko for frakturer.
English: There is no indication for FABLYN in children and adolescents below 18 years of age since the medicinal product is for use in postmenopausal women only.
Danish: Fablyn er ikke indiceret til børn og unge under 18 år, da lægemidlet kun anvendes til postmenopausale kvinder.
English: The reduction in the incidence of non-vertebral fractures was also observed in postmenopausal women with severe osteoporosis (defined as a baseline lumbar spine BMD T-score ≤ -2.5 + prevalent fracture or BMD T-score ≤ -3) (p = 0.0183).
Danish: Reduktionen i forekomsten af non-vertebrale frakturer blev også set hos postmenopausale kvinder med svær osteoporose (defineret som baseline lænderygsøjle-BMD T-score ≤2,5 + prævalent fraktur eller BMD T-score ≤ -3) (p = 0,0183).
English: FABLYN has no known influence on the ability to drive and use machines.
Danish: Fablyn har ingen kendt virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: These referrals were significantly less frequent in the FABLYN group (0.9%) than in the placebo group (3.3%).
Danish: Der var signifikant færre af disse henvisninger i Fablyn-gruppen (0,9 %) end i placebogruppen (3,3 %).
English: The tablet may be taken any time of day without regard to food and beverage intake.
Danish: Tabletten kan tages på alle tidspunkter af dagen og uden hensyntagen til indtagelse af mad og drikke.
English: As observed with other Selective Estrogen Receptor Modulators (SERMs), slightly decreased (approximately 4%) platelet counts were observed in lasofoxifene-treated patients in PEARL.
Danish: Som for andre selektive østrogenreceptormodulatorer (SERM) er der set et let fald (ca. 4 %) i trombocyttal hos lasofoxifenbehandlede patienter i PEARL-studiet.
English: Since less than 2% of lasofoxifene is recovered in urine as unchanged active substance, a study in subjects with renal insufficiency was not conducted.
Danish: Da mindre end 2 % af lasofoxifen genfindes i urinen som uomdannet substans, er der ikke foretaget undersøgelser på personer med nyreinsufficiens.
English: In some cases, these findings were observed to resolve spontaneously on treatment.
Danish: I nogle tilfælde sås spontan remission af disse fund under behandlingen.
English: BATCH NUMBER Lot:
Danish: FREMSTILLERENS BATCHNUMMER Lot:
English: A less serious event, superficial thrombophlebitis, also has been reported more frequently with FABLYN compared to placebo.
Danish: En mindre alvorlig hændelse, overfladisk tromboflebit, er også set hyppigere med Fablyn sammenlignet med placebo.
English: Vaginal discharge occurred in about one in 26 patients.
Danish: Vaginalt udflåd sås hos 1 ud af 26 patienter.
English: • Abnormal dreams, mood swings
Danish: • Unormale drømme, humørsvingninger
English: Lasofoxifene is a SERM whose biological actions are largely mediated through binding to estrogen receptors.
Danish: Lasofoxifen er en SERM, hvis biologiske virkninger overvejende medieres gennem binding til østrogenreceptorer.
English: The safety of FABLYN in the treatment of osteoporosis was also assessed in a Phase 2 placebocontrolled trial in Japanese, Korean and Taiwanese women.
Danish: Fablyns sikkerhed ved osteoporosebehandling blev også vurderet i et fase-2 placebokontrolleret studie med japanske, koreanske og taiwanesiske kvinder.
English: Do not take FABLYN
Danish: Tag ikke FABLYN
English: Lasofoxifene was not teratogenic in rats up to a dose of 10mg/kg (approximately 53 times the AUC in humans) or rabbits up to a dose of 3 mg/kg (below the level of systemic exposure in humans).
Danish: Lasofoxifen var ikke teratogen hos rotter op til en dosis på 10 mg/kg (ca. 53 gange AUC hos mennesker) eller kaniner op til en dosis på 3 mg/kg (under niveauet for systemisk eksponering hos mennesker).
English: An analysis was conducted of the subjects who were referred to their physician for consideration of treatment with an alternative osteoporosis medicinal product if one of the following was observed: a) ≥7% BMD loss at LS or ≥10% BMD loss at femoral neck at Month 12; b) ≥11% BMD loss at lumbar spine (LS) or ≥14% BMD loss at femoral neck at Month 24; c) ≥2 on-study radiographic vertebral fractures by Month 24.
Danish: Der blev foretaget en analyse af de patienter, der blev henvist til egen læge med henblik på eventuelt præparatskifte efter observation af et af følgende fund: a) ≥7 % BMD-tab i lænderygsøjle eller ≥10 % BMD-tab i lårbenshals efter 12 måneder; b) ≥11 % BMD-tab i lænderygsøjle eller ≥14 % BMD-tab i lårbenshals efter 24 måneder; c) ≥2 on-study radiografisk verificerede rygsøjlefrakturer efter 24 måneder.
English: FABLYN may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with estrogen deficiency.
Danish: Fablyn øger muligvis hyppigheden af hedeture og kan ikke mindske forekomsten af hedeture forbundet med østrogenmangel.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Disse er beskrevet i den Pharmacovigilance-plan, der er vedtaget i version 1.4 af Risk Management Planen (RMP), som er præsenteret i modul 1.8.2 af ansøgningen om markedsføringstilladelse og enhver følgende opdatering af RMP vedtaget af CHMP
English: Statistically significant increases were seen for apolipoprotein A-1, which is associated with HDL cholesterol, and serum triglycerides (median changes vs. placebo 6.1% and 4.9%, respectively).
Danish: Der blev set statistisk signifikante stigninger i apolipoprotein A-1, som er associeret med HDL-kolesterol, og i serumtriglycerider (gennemsnitlig ændring vs. placebo henholdsvis 6,1 % og 4,9 %).
English: The number of subjects discontinuing treatment as a result of vaginal bleeding was low [FABLYN: 4 (0.1%), placebo: 0].
Danish: Antallet af patienter, der fik seponeret behandlingen på grund af vaginalblødning, var lavt [Fablyn: 4 (0,1 %), placebo: 0].
English: B. CONDITIONS OF THE MARKETING AUTHORISATION
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: The apparent oral clearance (CL/F) of lasofoxifene in postmenopausal women is approximately 6.6 l/hr.
Danish: Lasofoxifens orale clearance (CL/F) hos postmenopausale kvinder er ca. 6,6 l/time.
English: For oral use
Danish: Oral anvendelse
English: Clinical data indicate that FABLYN has an estrogen-like agonist effect on bone as well as antagonistic effects on the breast.
Danish: Kliniske data indikerer, at Fablyn har en østrogenlignende virkning på knoglevæv såvel som antagonistiske virkninger på brystvæv.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER BEHOLDER ETIKET
English: Pregnancy and lactation: FABLYN is only for use in postmenopausal women.
Danish: Graviditet og amning: Fablyn må kun anvendes til postmenopausale kvinder.
English: At 5 years in the overall study population (N=8,556), the incidence of major coronary events, including coronary death, non-fatal myocardial infarction, new ischemic heart disease, hospitalization for unstable angina, and revascularisation procedures, was significantly lower.
Danish: For hele studiepopulationen (N=8556) var der efter 5 år signifikant lavere forekomst af alvorlige koronare hændelser, herunder koronardød, ikke-fatal myokardieinfarkt, ny iskæmisk hjertesygdom, hospitalisering på grund af ustabil angina pectoris og revaskulariseringsprocedurer.
English: The effects of FABLYN on BMD in postmenopausal Japanese, Korean and Taiwanese women with osteoporosis were also examined in a one-year, randomized, placebo-controlled, double-blind osteoporosis treatment trial.
Danish: Fablyns virkning på BMD hos postmenopausale japanske, koreanske og taiwanesiske kvinder med osteoporose blev også undersøgt i et 1-års randomiseret, placebokontrolleret, dobbelblindt osteoporosestudie.
English: FABLYN may be administered any time of day without regard to food or beverage intake.
Danish: Fablyn kan administreres på alle tidspunkter af dagen uden hensyntagen til indtagelse af mad og drikke.
English: A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).
Danish: Der er påvist en signifikant reduktion i forekomsten af vertebrale og non-vertebrale frakturer, men ikke hoftefrakturer (se pkt.
English: Vaginal bleeding was reported in 74 (2.6%) FABLYN-treated women versus 37 (1.3%) placebo-treated women.
Danish: Vaginalblødning blev set hos 74 (2,6 %) Fablyn-behandlede kvinder versus 37 (1,3 %) placebobehandlede kvinder.
English: SmPC, including contraindication of FABLYN in patients with active or past history of VTE.
Danish: herunder kontraindikationen vedrørende patienter med aktiv eller tidligere tilfælde af VTE.
English: No dose adjustment for FABLYN is necessary in elderly patients.
Danish: Dosisjustering af Fablyn er ikke nødvendig hos ældre patienter.
English: Lasofoxifene is slowly absorbed from the gastrointestinal tract with maximal plasma concentrations attained on average by approximately 6 hours after dosing.
Danish: Lasofoxifen absorberes langsomt fra mave-tarm-kanalen og maksimale plasmakoncentrationer opnås gennemsnitligt 6 timer efter dosering.
English: Lasofoxifene is extensively metabolized in humans.
Danish: Lasofoxifen undergår omfattende metabolisme i mennesker.
English: Women in this study had a median age of 63 years (range 44 to 79) and a median time since menopause of 13 years.
Danish: Kvinderne i dette studie var i gennemsnit 63 år (interval 44 til 79) og i gennemsnit var der gået 13 år siden menopausen.
English: Lasofoxifene has been administered to postmenopausal women at single doses as high as 100 mg (200 times the recommended unit dose) and multiple doses as high as 10 mg/day (20 times the recommended dose) for up to one year without dose-related serious adverse reactions.
Danish: Lasofoxifen er administreret til postmenopausale kvinder i enkeltdoser så høje som 100 mg (200 gange den anbefalede enkeltdosis) og i flere doser så høje som 10 mg dagligt (20 gange den anbefalede dosis) i op til et år uden alvorlige dosis-relaterede bivirkninger.
English: Biotransformation and disposition of lasofoxifene in humans have been determined following oral administration of 14C-labeled lasofoxifene.
Danish: Lasofoxifens biotransformation og disposition i mennesker er bestemt ved oral administration af 14C
English: No case of FABLYN overdose has been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering med Fablyn.
English: In a prenatal and postnatal study in rats, at ≥0.01 mg/kg/day lasofoxifene delayed and/or disrupted parturition, increased pup mortality at birth, altered the achievement of developmental milestones, and reduced growth.
Danish: I en prænatal og postnatal undersøgelse af lasofoxifen hos rotter, der fik ≥0.01 mg/kg/dag, sås forsinket og/eller afbrudt partus, forøget mortalitet hos ungerne ved fødslen, ændret tidspunkt for udviklingstrin og nedsat vækst.
English: Any unexplained breast abnormality occurring during FABLYN therapy should be investigated.
Danish: Alle uforklarede mammaforandringer, opstået under Fablyn-behandling, bør undersøges.
English: Pathologists should be made aware of a history of lasofoxifene use when assessing endometrial histology, to ensure an accurate diagnosis of benign cystic atrophy when present.
Danish: Patologen skal informeres om patientens brug af lasofoxifen ved vurdering af endometriehistology for at sikre en præcis diagnose af benign cystisk atrofi.
English: Relative to placebo, FABLYN significantly decreased total cholesterol, LDL cholesterol, LDL-associated apolipoprotein B-100, and high sensitivity C-reactive protein (median changes -10.4%, -15.8%, -11.8%, -12.5%, respectively); no significant changes versus placebo were seen for HDL cholesterol or VLDL cholesterol.
Danish: I forhold til placebo nedsatte Fablyn signifikant totalkolesterol, LDL-kolesterol, LDL-associeret apolipoprotein B-100 og high-sensitivity C-reaktivt protein (gennemsnitlige ændringer henholdsvis -10,4 %, -15,8 %, -11,8 %, -12,5 %); Der blev ikke set signifikante ændringer af HDL-kolesterol eller VLDL-kolesterol.
English: Decreases in estrogen levels after menopause or oophorectomy lead to accelerated bone loss due to increased bone turnover, where bone resorption exceeds bone formation.
Danish: Fald i østrogenniveau efter menopause eller ooforektomi fører til accelereret knogletab på grund af forøget knogleomsætning, hvor knogleresorption overstiger knogledannelse.
English: The study population consisted of 8,556 postmenopausal women with osteoporosis as defined by low BMD (vertebral or hip BMD at least 2.5 standard deviations below the mean value for healthy young women).
Danish: Studiepopulationen bestod af 8556 postmenopausale kvinder med osteoporose, defineret ved lav BMD (rygsøjle- eller hofte-BMD mindst 2,5 SD under den gennemsnitlige værdi for raske unge kvinder).
English: FABLYN also significantly increased whole body bone mineral content (BMC), compared to placebo, at 3 years.
Danish: Fablyn øgede også signifikant helkrops-knoglemineralindholdet (BMC) sammenlignet med placebo efter 3 år.