natgillin/translations-raw huggingface dataset:
Filmovertrukken tablet. 
Film-coated tablet.
Vigtig information om nogle af de øvrige indholdsstoffer i FABLYN FABLYN indeholder lactose. 
Important information about some of the ingredients of FABLYN FABLYN contains lactose.
Muskelsitren sås hos 1 ud af 9 patienter. 
Muscle spasms occurred in about one in 9 patients .
• hvis De er overfølsom (allergisk) over for lasofoxifen eller et af de øvrige indholdsstoffer. 
• if you are allergic (hypersensitive) to lasofoxifene or any of the other ingredients of FABLYN.
• Behovet for at stoppe behandlingen med FABLYN og foretage undersøgelser, hvis der opstår uforudset uterusblødning. 
• The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs.
Hvis De sidder for lang tid i den samme stilling, kan Deres blodcirkulation forværres, og det øger risikoen for blodpropper. 
This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots.
Behandlingen nedsatte også knogleomsætningsmarkører. 
It also reduced markers of bone turnover.
Der findes ingen specifik antidot til Fablyn. 
There is no specific antidote for FABLYN.
Virkninger på endometriet: 
Effects on the endometrium:
Rygsøjlefrakturer er den mest almindelige type fraktur som følge af osteoporose hos postmenopausale kvinder. 
Vertebral fractures are the most common type of osteoporotic fracture in postmenopausal women.
5-årsresultater fra stort, multinationalt frakturstudie (PEARL) 
5-year results from large, multinational fracture trial (PEARL)
Postmenopausale kvinder behøver i gennemsnit 1500 mg calcium dagligt. 
Postmenopausal women require an average of 1,500 mg/day of elemental calcium.
Warfarin - Lasofoxifen havde ingen virkning på farmakokinetikken af R- og S-warfarin. 
Warfarin - Lasofoxifene had no effect on the pharmacokinetics of R- and S- warfarin.
Farmakoterapeutisk klassifikation: Selektiv østrogenreceptormodulator (SERM), ATC-kode: {not yet assigned} 
Pharmacotherapeutic group: Selective Estrogen Receptor Modulator (SERM), ATC code: {not yet assigned}
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Eberth 
NAME OF THE MARKETING AUTHORISATION HOLDER Eberth
Indehaveren af markedsføringstilladelsen skal også give adgang til uddannelsesprogrammer for patologer. 
The MAH shall also provide access to educational programme for pathologists.
-Non-vertebrale frakturer 
-Non-vertebral fractures
Denne analyse inkluderede 2049 postmenopausale kvinder, bestående af 85,5 % kaukasiske, 8,6 % latin-amerikanske, 3,4 % asiatiske og 1,9 % afro-amerikanske kvinder. 
This analysis included 2,049 postmenopausal women consisting of 85.5% Caucasian, 8.6% Hispanic, 3.4% Asian, and 1.9% African American.
Nogle asymptomatiske patienter kan muligvis opleve hedeture efter start af behandling. 
In some asymptomatic patients, hot flushes may occur upon beginning therapy.
Hjælpestoffer: Hver filmovertrukken tablet indeholder 71,34 mg lactose. 
Excipient: Each film-coated tablet contains 71.34 mg lactose.
Indehaveren af markedsføringstilladelsen skal inden lanceringstidspunktet sikre, at alle læger, som forventes at udskrive FABLYN eller anvende gynækologisk ultralyd på patienter behandlet med FABLYN, har adgang til et risikominimerings-uddannelsesprogram. 
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all healthcare professionals who are expected to prescribe FABLYN or order gynaecological ultrasound of patients treated with FABLYN, are provided with access to risk minimisation educational programme.
Resultaterne fra et fase 1-studie hos japanske og kaukasiske kvinder stemmer overens med den populationsfarmakokinetiske analyse og viser ingen forskelle i lasofoxifens farmakokinetik mellem disse 2 populationer. 
The results of a phase 1 study in Japanese and Caucasian women was consistent with the population pharmacokinetic analysis and showed no discernible difference in lasofoxifene pharmacokinetics in these two populations.
Denne reduktion blev set gennem det første år og blev fastholdt gennem 5 år. 
This decrease was observed through the first year and was maintained through 5 years.
Alle tilfælde af uforklaret vaginalblødning skal undersøges, hvis det er klinisk indiceret. 
Any unexplained vaginal bleeding should be investigated as clinically indicated.
• hvis De tager FABLYN, bør De motionere (f.eks. gå ture) eller lave regelmæssige øvelser med Deres ben og fødder, hvis De rejser over lange afstande. 
• if you are taking FABLYN, you should walk around or exercise your legs and feet at regular intervals when traveling long distances.
I dette studie øgede Fablyn signifikant rygsøjle- og hofte-BMD (total hofte og alle subkomponenter af hoften) med 2 til 4 %. 
In this study, FABLYN significantly increased spine and hip (total hip and all subcomponents of the hip) BMD by 2 to 4%.
Gennemsnitlig international normalized ratio (INR)-AUC og maksimal værdi af INR efter en enkeltdosis warfarin, administreret sammen med lasofoxifen, var henholdsvis ca. 8 % og 16 % lavere end efter warfarin alene. 
Mean international normalized ratio (INR) AUC and maximum value of INR after single-dose warfarin administration with lasofoxifene were approximately 8% and 16% lower, respectively, than after warfarin alone.
Virkninger på vulvovaginal atrofi (VVA): 
Effects on vulvar and vaginal atrophy (VVA):
YDERLIGERE OPLYSNINGER 
Further information
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. 
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.
Lasofoxifen har været forbundet med benigne endometrielle påvirkninger. 
Lasofoxifene has been associated with benign endometrial effects.
Mindre end 2 % af den administrerede dosis blev genfundet i urinen som uomdannet lasofoxifen. 
Less than 2% of the administered dose was recovered in the urine as unchanged lasofoxifene.
Da Fablyn udelukkende er indiceret til brug hos postmenopausale kvinder, er der ikke foretaget nogen vurdering af effekten af køn på lasofoxifens farmakokinetik. 
Since FABLYN is indicated for use only in postmenopausal women, no assessment of the effect of gender on lasofoxifene pharmacokinetics has been made.
Farmakokinetiske data fra mere end 2000 postmenopausale kvinder, inklusive patienter i udvalgte osteoporose-studier, har dannet grundlag for en populationsfarmakokinetisk analyse. 
Pharmacokinetic data from over 2,000 postmenopausal women including patients in selected osteoporosis clinical trials contributed to a population pharmacokinetic analysis.
• På papir 
• Printed on paper
Der sås også andre venøse tromboemboliske hændelser. 
Other venous thromboembolic events could also occur.
• FABLYN øger risikoen for venøs tromboemboli (VTE). 
• FABLYN increases risk of venous thromboembolism (VTE).
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Forseglet pakning. 
OTHER SPECIAL WARNING(S), IF NECESSARY Sealed pack.
Lasofoxifen var ikke genotoksisk i nogen af de omfattende tests, som blev benyttet. 
Lasofoxifene was not genotoxic in any of the battery of tests applied.
Det er derfor usandsynligt, at Fablyn ændrer farmakokinetikken af lægemidler, der metaboliseres via disse CYPisoformer eller transporteres af MDR1 P-glycoprotein. 
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.
Den anbefalede dosis er en tablet på 500 µg dagligt. 
The recommended dose is one 500 microgram tablet daily.
Hæmningen af knogleomsætningsmarkørerne kunne påvises efter 3 måneder og blev fastholdt gennem en observationsperiode på 36 måneder i et substudie under PEARL-studiet. 
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.
Lasofoxifen har en halveringstid på ca. 6 dage. 
Lasofoxifene has a half-life of approximately 6 days.
• Smerter ved vandladning, blod i urinen 
• Painful urination, blood in urine
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. 
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.
Det anbefalede daglige indtag af vitamin D er 400-800 IU. 
The recommended intake of vitamin D is 400-800 IU daily.
Signifikante stigninger i BMD blev set så tidligt som efter 3 måneder for lænderygsøjle og total hofte. 
Significant increases in BMD were observed as early as 3 months for lumbar spine and total hip.
Skeletale virkninger: 
Skeletal effects:
Derfor bør Fablyn kun bruges til behandling af osteoporose, efter at behandlingen for mammacancer, herunder adjuverende behandling, er afsluttet. 
Therefore, FABLYN should be used for the treatment of osteoporosis only after the treatment of breast cancer, including adjuvant therapy, has been completed.
• Trykken i den nedre del af maven 
• Pressure in the lower abdomen
Knoglevæv, der nydannes gennem to år under behandling med lasofoxifen, er af normal kvalitet. 
Bone formed during two years' administration of lasofoxifene is of normal quality.
Disse observationer støtter konklusionen, at lasofoxifen ikke har nogen egen østrogenagonistisk aktivitet i brystvæv. 
These observations support the conclusion that lasofoxifene has no intrinsic estrogen agonist activity in breast tissue.
Fablyns virkning på lipidprofilen blev undersøgt i et 3-års substudie under PEARL-studiet; substudiet involverede 1014 postmenopausale kvinder. 
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.
De fleste bivirkninger, som er set, var milde. 
Most of the side effects that occurred during studies were mild.
** Endometriehyperplasi-hændelser baseret på indrapporteringer fra investigatorer uden histopatologi og uden histologisk verifikation. 
** Endometrial hyperplasia events based on investigator reporting rather than histopathology findings and did not require histological confirmation.
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN 
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Forekomsten af cystiske endometrieforandringer og endometrietykkelse blev undersøgt hos en undergruppe af studiepopulationen (298 patienter) ved en årlig transvaginal ultralydsundersøgelse (TVU) gennem 3 år. 
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.
• FABLYN medfører morfologiske forandringer, især cystisk atrofi i endometriet. 
• FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Følgende information om Fablyns virkning på endometriet gennem 5 års eksponering kommer fra PEARL-studiet. 
The following results of the effects of FABLYN on the endometrium through 5 years of exposure are reported from the PEARL study.
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. 
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.
Så enhver blødning fra skeden, mens De tager FABLYN, er derfor unormal. 
So any vaginal bleeding while you take FABLYN is unexpected.
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. 
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.
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). 
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).
Sikkerheden af Fablyn ved osteoporosebehandling blev vurderet i et stort (8556 patienter) dobbeltblindt, randomiseret, placebokontrolleret multinationalt fase 3-fraktur-studie (PEARL-studiet). 
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).
Den øgede omsætning medfører accelereret knogletab, da den kompensatoriske øgning i knogledannelsen ikke er tilstrækkelig til at opveje den øgede knogleresorption. 
The increased turnover causes accelerated bone loss because the compensatory increase in bone formation is not sufficient to offset increased bone resorption.
Dyreforsøg har vist udskillelse af lasofoxifen i mælk. 
Animal studies have shown excretion of lasofoxifene in milk.
• Aktivt stof: lasofoxifen. 
• The active substance is lasofoxifene.
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. 
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.
Fablyn indeholder lactose. 
FABLYN contains lactose.
Indehaver af markedsføringstilladelsen er: Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Tyskland. 
Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Germany.
Studiepopulationen bestod af 497 kvinder med osteoporose, defineret ved lav rygsøjle-BMD (Tscore ≤ 2,5). 
The study population consisted of 497 women with osteoporosis as defined by low vertebral BMD (T-score ≤ 2.5).
Fablyn er indiceret til behandling af osteoporose hos postmenopausale kvinder med øget risiko for frakturer. 
FABLYN is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Fablyn er ikke indiceret til børn og unge under 18 år, da lægemidlet kun anvendes til postmenopausale kvinder. 
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.
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). 
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).
Fablyn har ingen kendt virkning på evnen til at føre motorkøretøj eller betjene maskiner. 
FABLYN has no known influence on the ability to drive and use machines.
Der var signifikant færre af disse henvisninger i Fablyn-gruppen (0,9 %) end i placebogruppen (3,3 %). 
These referrals were significantly less frequent in the FABLYN group (0.9%) than in the placebo group (3.3%).
Tabletten kan tages på alle tidspunkter af dagen og uden hensyntagen til indtagelse af mad og drikke. 
The tablet may be taken any time of day without regard to food and beverage intake.
Som for andre selektive østrogenreceptormodulatorer (SERM) er der set et let fald (ca. 4 %) i trombocyttal hos lasofoxifenbehandlede patienter i PEARL-studiet. 
As observed with other Selective Estrogen Receptor Modulators (SERMs), slightly decreased (approximately 4%) platelet counts were observed in lasofoxifene-treated patients in PEARL.
Da mindre end 2 % af lasofoxifen genfindes i urinen som uomdannet substans, er der ikke foretaget undersøgelser på personer med nyreinsufficiens. 
Since less than 2% of lasofoxifene is recovered in urine as unchanged active substance, a study in subjects with renal insufficiency was not conducted.
I nogle tilfælde sås spontan remission af disse fund under behandlingen. 
In some cases, these findings were observed to resolve spontaneously on treatment.
FREMSTILLERENS BATCHNUMMER Lot: 
BATCH NUMBER Lot:
En mindre alvorlig hændelse, overfladisk tromboflebit, er også set hyppigere med Fablyn sammenlignet med placebo. 
A less serious event, superficial thrombophlebitis, also has been reported more frequently with FABLYN compared to placebo.
Vaginalt udflåd sås hos 1 ud af 26 patienter. 
Vaginal discharge occurred in about one in 26 patients.
• Unormale drømme, humørsvingninger 
• Abnormal dreams, mood swings
Lasofoxifen er en SERM, hvis biologiske virkninger overvejende medieres gennem binding til østrogenreceptorer. 
Lasofoxifene is a SERM whose biological actions are largely mediated through binding to estrogen receptors.
Fablyns sikkerhed ved osteoporosebehandling blev også vurderet i et fase-2 placebokontrolleret studie med japanske, koreanske og taiwanesiske kvinder. 
The safety of FABLYN in the treatment of osteoporosis was also assessed in a Phase 2 placebocontrolled trial in Japanese, Korean and Taiwanese women.
Tag ikke FABLYN 
Do not take FABLYN
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). 
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).
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. 
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.
Fablyn øger muligvis hyppigheden af hedeture og kan ikke mindske forekomsten af hedeture forbundet med østrogenmangel. 
FABLYN may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with estrogen deficiency.
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 
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.
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 %). 
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).
Antallet af patienter, der fik seponeret behandlingen på grund af vaginalblødning, var lavt [Fablyn: 4 (0,1 %), placebo: 0]. 
The number of subjects discontinuing treatment as a result of vaginal bleeding was low [FABLYN: 4 (0.1%), placebo: 0].
B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN 
B. CONDITIONS OF THE MARKETING AUTHORISATION
Lasofoxifens orale clearance (CL/F) hos postmenopausale kvinder er ca. 6,6 l/time. 
The apparent oral clearance (CL/F) of lasofoxifene in postmenopausal women is approximately 6.6 l/hr.
Oral anvendelse 
For oral use
Kliniske data indikerer, at Fablyn har en østrogenlignende virkning på knoglevæv såvel som antagonistiske virkninger på brystvæv. 
Clinical data indicate that FABLYN has an estrogen-like agonist effect on bone as well as antagonistic effects on the breast.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner. 
No studies on the effects on the ability to drive and use machines have been performed.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER BEHOLDER ETIKET 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Graviditet og amning: Fablyn må kun anvendes til postmenopausale kvinder. 
Pregnancy and lactation: FABLYN is only for use in postmenopausal women.
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. 
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.
Fablyns virkning på BMD hos postmenopausale japanske, koreanske og taiwanesiske kvinder med osteoporose blev også undersøgt i et 1-års randomiseret, placebokontrolleret, dobbelblindt osteoporosestudie. 
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.
Fablyn kan administreres på alle tidspunkter af dagen uden hensyntagen til indtagelse af mad og drikke. 
FABLYN may be administered any time of day without regard to food or beverage intake.
Der er påvist en signifikant reduktion i forekomsten af vertebrale og non-vertebrale frakturer, men ikke hoftefrakturer (se pkt. 
A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).
Vaginalblødning blev set hos 74 (2,6 %) Fablyn-behandlede kvinder versus 37 (1,3 %) placebobehandlede kvinder. 
Vaginal bleeding was reported in 74 (2.6%) FABLYN-treated women versus 37 (1.3%) placebo-treated women.
herunder kontraindikationen vedrørende patienter med aktiv eller tidligere tilfælde af VTE. 
SmPC, including contraindication of FABLYN in patients with active or past history of VTE.
Dosisjustering af Fablyn er ikke nødvendig hos ældre patienter. 
No dose adjustment for FABLYN is necessary in elderly patients.
Lasofoxifen absorberes langsomt fra mave-tarm-kanalen og maksimale plasmakoncentrationer opnås gennemsnitligt 6 timer efter dosering. 
Lasofoxifene is slowly absorbed from the gastrointestinal tract with maximal plasma concentrations attained on average by approximately 6 hours after dosing.