natgillin/translations-raw huggingface dataset:
Tabel 1: Bivirkninger set i placebokontrollerede osteoporose-studier med en højere hyppighed hos Fablyn-behandlede end hos placebobehandlede kvinder 
Table 1: Adverse reactions observed in placebo-controlled osteoporosis treatment clinical trials in more FABLYN-treated women than in placebo-treated women
Det endokrine system 
Endocrine disorders
Ifølge klinisk praksis (og retningslinjer for postmenopausale kvinder), vil disse benigne fund dog ikke berettige til yderligere undersøgelser hos kvinder uden vaginalblødning, da risikoen ved en diagnostisk undersøgelse af uterus overstiger fordelene. 
However, in clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding (in accordance with guidelines for postmenopausal women), as the risks of diagnostic uterine procedures in asymptomatic women outweigh any benefits.
Hvis De er gravid eller ammer, må De ikke tage FABLYN, da det kan udskilles i modermælken. 
Do not take FABLYN if you are pregnant or breast-feeding as it might be excreted in mother's milk.
Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig. 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Fablyn er ikke undersøgt hos kvinder med mammacancer i anamnesen. 
FABLYN has not been studied in women with a prior history of breast cancer.
I 2-års carcinogenicitets-undersøgelser på rotter (≥1 mg/kg/dag; 7 gange den systemiske eksponering efter en human dosis på 0,5 mg/dag, baseret på plasma-AUC) sås en øget forekomst af renale tubulære adenomer og carcinomer hos hanner og granulosacelletumorer i ovarierne hos hunner. 
In two-year carcinogenicity studies conducted in rats (≥1 mg/kg/day; 7 times systemic exposure following a human dose of 0.5 mg/day based on plasma AUC) an increased incidence of renal tubular adenoma and carcinoma in males and granulosa cell tumours of the ovary in females was noted.
Bindingsaffiniteter for de vigtigste cirkulerende metabolitter af lasofoxifen var mindst henholdsvis 31 og 18 gange mindre end bindingsaffiniteten for lasofoxifen til østrogenreceptor alpha og østrogenreceptor beta. 
The binding affinities of the major circulating metabolites of lasofoxifene were at least 31-fold and 18fold less than those of lasofoxifene for the estrogen receptor alpha and the estrogen receptor beta, respectively, indicating that these metabolites are unlikely to contribute to the pharmacologic activity of lasofoxifene.
Almindelige bivirkninger relateret til Fablyn var muskeltrækninger, hedeture og vaginalt udflåd. 
Common adverse reactions considered to be related to FABLYN therapy were muscle spasms, hot flush and vaginal discharge.
Der var 0,48 hændelser/100 patientår i placebo-gruppen og 0,36 hændelser/100 patientår blandt Fablyn-behandlede patienter (HR = 0,75; 95 % CI 0,51; 1,10 p = 0,140). 
There were 0.48 events/100 patient years in the placebo group and 0.36 events/100 patient years among FABLYN-treated patients (HR = 0.75; 95% CI 0.51, 1.10, p = 0.140).
MARKEDSFØRINGSTILLADELSESNUMRE EU/1/08/500/001 
MARKETING AUTHORISATION NUMBER EU/1/08/500/001
For at vurdere knoglekvaliteten, blev der efter 2 års behandling taget knoglebiopsier fra 71 postmenopausale kvinder. 
To assess bone quality, bone biopsies were obtained from 71 postmenopausal women enrolled in BMD trials after 2 years of treatment.
• Nedsat puls i fødderne, blå mærker 
• Decreased pulse in feet, bruising
Venøse Tromboemboliske hændelser (VTE): Den alvorligste bivirkning relateret til Fablyn var VTE (dyb venetrombose, lungeemboli og retinal venetrombose). 
Venous Thromboembolic Events: The most serious adverse reaction related to FABLYN was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis).
Aktuelle eller tidligere venøse tromboemboliske hændelser, herunder dyb venetrombose, lungeemboli og retinal venetrombose. 
Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
De har en alvorlig leversygdom. 
• if you have severe liver disease.
• Mundtørhed, luftafgang fra tarmen (meget luft i maven eller tarmen), mavepine 
• Dry mouth, flatulence (excessive amount of air or gases in the stomach or the intestine),
Det vides ikke, om lasofoxifen udskilles i modermælken. 
It is not known whether lasofoxifene is excreted in human milk.
I fertilitets-undersøgelser med rotter sås en lille påvirkning af hannernes reproduktive ydeevne ved doser ≥10 mg/kg/dag (ca. 42 gange AUC hos mennesker), hvilket kom til udtryk i en nedsættelse af parringsindeks, implantationssteder og fostre. 
In fertility studies conducted in rats with lasofoxifene, slight effects on male reproductive performance occurred at ≥10 mg/kg/day (approximately 42 times the AUC in humans) as evidenced by decreases in copulation index, implantation sites, and fetuses sired.
En øget forekomst af analatresi, hypoplasti af halen, ødemer og fleksur af ekstremiteter blev observeret hos fostre af gravide rotter, der havde fået doser på 100 mg/kg (ca. 400 gange AUC hos mennesker), og var forbundet med en øget embryo-føtal letalitet og generel mistrivsel. 
Increased incidence of imperforate anus, hypoplastic tail, edema and limb flexures noted in fetuses of pregnant rats dosed at 100 mg/kg (approximately 400 times the AUC in humans) were associated with increased embryo-fetal lethality and generalized failure to thrive.
Brug ikke FABLYN efter den udløbsdato, der står på Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.. 
The expiry date refers to the last day of that month.
FABLYN er en trekantet, ferskenfarvet, filmovertrukken tablet mærket med “Pfizer” på den ene side og “OPR 05” på den anden side. 
What FABLYN looks like and contents of the pack FABLYN tablets are triangular, peach coloured, film-coated tablets marked with “Pfizer” on one side and “OPR 05” on the other.
Disse omfattede hos visse forsøgspersoner en mindre stigning i forekomsten af vaginalblødning såvel som cystiske endometrieforandringer, set ved ultralydsundersøgelser og histologisk påvist benign cystisk atrofi (en variant af atrofisk endometrium). 
These included, in some subjects, a small excess in the incidence of vaginal bleeding as well as endometrial cystic change viewed on ultrasound and histological benign cystic atrophy (a variant of atrophic endometrium).
Der var 0,51 hændelser/100 patientår hos Fablyn-behandlede patienter sammenlignet med 0,75 hændelser/100 patientår hos placebobehandlede patienter (HR 0,68; 95 % CI 0,50; 0,93, p= 0,016). 
There were 0.51 events/100 patient-years for FABLYN-treated patients compared to 0.75 events/100 patient-years in placebo-treated patients (HR 0.68; 95% CI 0.50, 0.93, p= 0.016).
• Unormal eller uregelmæssig hjertebanken, hurtig puls 
• Abnormal or irregular beating of the heart, increased heart rate
Efter oral administration af en opløsning af 14C-mærket lasofoxifen i mennesker genfandtes ca. 72 % af den radioaktive dosis efter 24 
Following oral administration of 14C-labeled lasofoxifene in solution to humans, approximately 72% of the radioactive dose was recovered by day 24 (approximately 66% in feces and 6% in urine).
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
I kliniske studier er der set en øget risiko for venøse tromboemboliske hændelser (dyb venetrombose og lungeemboli) hos Fablyn-behandlede kvinder sammenlignet med placebo. 
In clinical trials, FABLYN-treated women had an increased risk of venous thromboembolic events (deep vein thrombosis and pulmonary embolism) compared to placebo.
Knoglehistomorfometri 
Bone histomorphometry
I Fablyn gruppen fik signifikant færre kvinder multiple radiografisk verificerede rygsøjlefrakturer sammenlignet med placebogruppen gennem 5 års behandling (p < 0,0001). 
Significantly fewer women experienced multiple radiographic vertebral fractures in the FABLYN treatment group versus the placebo group throughout 5 years of dosing (p < 0.0001).
FABLYN hører til den gruppe af ikke-hormonel medicin, der kaldes selektive østrogenreceptor-modulerende stoffer (SERM). 
It belongs to a group of medicines called Selective Estrogen Receptor Modulators (SERM).
FARMAKOLOGISKE EGENSKABER 
PHARMACEUTICAL PARTICULARS
FABLYN anvendes til behandling af knogleskørhed hos kvinder, der har passeret overgangsalderen (postmenopausal knogleskørhed), og som har øget risiko for knoglebrud, især i rygsøjlen, hofterne eller håndleddene. 
FABLYN is used to treat osteoporosis in women after the menopause (postmenopausal osteoporosis) who are likely to break bones, especially in the spine, hips and wrists.
I alt 124 kvinder fik Fablyn og 125 fik placebo. 
The duration of treatment in postmenopausal women was 12 months, 124 were exposed to FABLYN and 125 were exposed to placebo.
Begrænsede kliniske data tyder på, at lasofoxifen kan være forbundet med en stigning i triglyceridniveauet i serum hos patienter med tidligere oral østrogeninduceret hypertriglyceridæmi (>5,6 mmol/l). 
Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (> 5.6 mmol/l), lasofoxifene may be associated with a marked increase in serum triglycerides.
Samtidig brug af Fablyn og systemisk behandling med østrogener eller hormoner er ikke undersøgt. 
The concurrent use of FABLYN and systemic estrogen or hormone therapy has not been studied and therefore concomitant use of FABLYN with systemic estrogens is not recommended.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder lasofoxifentartrat, svarende til 500 μg lasofoxifen. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms lasofoxifene.
De har en alvorlig nyresygdom. 
• if you have severe kidney disease.
Abnormt cervix-smear, forhøjet alanin-aminotransferase, forhøjet blodsukker, forhøjede 
Common: Aspartate aminotransferase increased Uncommon: Alanine aminotransferase increased, blood glucose increased, smear cervix abnormal,
• Meget sjældne bivirkninger: Forekommer hos færre end 1 ud af 10.000 patienter 
• Very rare: affects less than 1 user in 10,000
Ikke almindelig: 
Rare:
• Spørg lægen eller på apoteket, hvis der er mere, De vil vide. 
• If you have any further questions, ask your doctor or pharmacist.
Fablyn er beregnet til langtidsbrug på grund af sygdommens kroniske natur (se pkt. 
Due to the chronic nature of the disease process, FABLYN is intended for long-term use (see section 5.1).
Radiografisk verificerede rygsøjlefrakturer 
-Radiographic vertebral fractures
Meget almindelige bivirkninger: 
Very common side effects:
• Tørre øjne, hårtab, hududslæt, nattesved, kløe, varmefølelse, vægtøgning 
• Dry eye, hair loss, skin rash, night sweats, itching, feeling hot, weight gain
Behandlingen blev seponeret som følge af bivirkninger hos 12,9 % af de Fablyn-behandlede kvinder og 12,3 % af de placebobehandlede kvinder. 
Within this study, 12.9% of FABLYN-treated women and 12.3% of placebo-treated women discontinued therapy due to adverse events.
Lasofoxifens 2 primære eliminationsveje er oxidering af en række cytochrome P450-systemer, herunder CYP 2D6 og 3A4/5, samt konjugering af lasofoxifen. 
Oxidation, by multiple cytochrome P450s including CYPs 2D6 and 3A4/5, and conjugation of lasofoxifene are the two primary mechanisms of elimination of lasofoxifene from the systemic circulation.
• Forstoppelse 
• Constipation
Indehaver af markedsføringstilladelsen og fremstiller 
SUBSTANCE AND MANUFACTURING AUTHORISATION
Tabel 1 indeholder de bivirkninger, der blev set i de to osteoporose-studier med en højere hyppighed blandt Fablyn-behandlede personer end blandt placebo-behandlede personer. 
Table 1 lists adverse reactions occurring in the two osteoporosis treatment clinical trials that occurred at an incidence greater than placebo.
Alle kliniske frakturer Procentdel af patienter med kliniske frakturer n=2852 
All clinical fractures Percentage of patients with clinical fracture n=2,852
Køn: 
Gender:
Hos kvinder med knogleskørhed efter overgangsalderen nedsætter FABLYN risikoen for brud i rygsøjlen (vertebrale brud) og brud i arme, ben og håndled, (ikke-vertebrale brud), men ikke hoftebrud. 
In women with postmenopausal osteoporosis, FABLYN reduces the risk of both fractures of the spine (vertebral fractures) and non-spine fractures (non-vertebral fractures), but not hip fractures.
Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Vær ekstra forsigtig med at tage FABLYN 
Take special care with FABLYN
Sjældne bivirkninger: 
Rare side effects:
Der var ingen forskel i forekomsten af endometriekarcinom og endometriehyperplasi mellem Fablyn- og placebobehandlede kvinder. 
There was no difference between FABLYN- and placebo-treated women in the incidences of endometrial carcinoma and endometrial hyperplasia.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder lasofoxifentartrat, svarende til 500 mikrogram lasofoxifen. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains lasofoxifene tartrate, equivalent to 500 microgram lasofoxifene.
Dosisjustering af Fablyn er ikke nødvendig hos patienter med mild til moderat leverinsufficiens. 
No dose adjustment for FABLYN is necessary for patients with mild or moderate hepatic insufficiency.
Fablyn må ikke anvendes til kvinder i den fødedygtige alder, gravide eller ammende kvinder (se pkt. 
It must not be taken by women of child-bearing potential, pregnant women and lactating women (see section 4.6).
Tabletovertræk: 
Tablet coating:
Lasofoxifens farmakokinetik er ikke undersøgt hos børn. 
The pharmacokinetics of lasofoxifene have not been evaluated in a paediatric population.
Fablyn nedsatte signifikant forekomsten af alle kliniske frakturer fra 12,1 % for placebo til 9,3 % for Fablyn (relativ reduktion af risiko = 25 %, p = 0,0004). 
FABLYN significantly decreased the incidence of all clinical fractures from 12.1% for placebo to 9.3% for FABLYN (relative risk reduction = 25%, p = 0.0004).
Non-vertebrale frakturer Procentdel af patienter med non-vertebrale frakturer n=2852 
Non-vertebral fractures Percentage of patients with non-vertebral fracture n=2,852
Sjælden: Positionel vertigo, sygdom i det indre øre, ubehag i øret Hjerte 
Ear discomfort, inner ear disorder, vertigo positional Cardiac disorders
FABLYN indeholder: 
What FABLYN contains
Fablyn nedsatte signifikant forekomsten af non-vertebrale frakturer fra 10,4 % for placebo til 8,1 % for Fablyn (relativ reduktion af risiko = 24 %, p = 0,0020). 
FABLYN significantly decreased the incidence of non-vertebral fractures from 10.4% for placebo to 8.1% for FABLYN (relative risk reduction = 24%, p = 0.0020).
BMD og knoglebiomarkører hos postmenopausale kvinder med osteoporose blev undersøgt gennem 3 år i PEARLstudiet. 
The effects of FABLYN on fracture incidence (table 2) were examined through 5 years; and BMD and bone biomarkers in postmenopausal women with osteoporosis were examined through 3 years in the PEARL study.
Fablyn nedsatte signifikant forekomsten af nye radiografisk verificerede rygsøjlefrakturer (undtagen forværring af tidligere frakturer) fra 9,3 % for placebo til 5,6 % for Fablyn (relativ reduktion af risiko = 41 %, p < 0,0001). 
FABLYN significantly decreased the incidence of new radiographic vertebral fractures (excluding worsening of previous fractures) from 9.3% for placebo to 5.6% for FABLYN (relative risk reduction = 41%, p < 0.0001).
Lactosemonohydrat 
Lactose anhydrous
Ifølge klinisk praksis og retningslinjer for postmenopausale kvinder, vil disse benigne fund ikke berettige til yderligere undersøgelser hos kvinder uden vaginalblødning (se pkt. 
In clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding, in accordance with guidelines for postmenopausal women (see section 4.4).
Alopeci, erytem, nattesved, pruritus 
Uncommon: Alopecia, erythema, night sweats, pruritus Rare:
• Almindelige bivirkninger: Forekommer hos mellem 1 og 10 ud af 100 patienter 
• Common: affects 1 to 10 users in 100
Infektioner og parasitære sygdomme Ikke almindelig: 
Metabolism and nutrition disorders Uncommon: Diabetes mellitus Rare:
Sikkerhed og effekt af lasofoxifen er ikke undersøgt hos patienter med leverinsufficiens med leverfunktionstest >1,5 ULN. 
Safety and efficacy of lasofoxifene have not been evaluated in patients with hepatic insufficiency with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Sjælden: Følelse af beruselse, hypertermi, inflammation, polyp, thorakalt ubehag, udfyldning, ødem Undersøgelser 
Chest discomfort, feeling drunk, hyperthermia, inflammation, mass, oedema, polyp Investigations
• Meget almindelige bivirkninger: Forekommer hos flere end 1 ud af 10 patienter. 
• Very common: affects more than 1 user in 10
Sikkerhed og effekt af Fablyn er ikke undersøgt hos patienter med leverfunktionstest >1,5 ULN. 
Safety and efficacy of FABLYN have not been evaluated in patients with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Behandlingen blev seponeret som følge af bivirkninger hos 3,2 % af de Fablyn-behandlede og 8,0 % af de placebobehandlede kvinder. 
Within this study, 3.2% of FABLYN-treated women and 8.0% of placebo-treated women discontinued therapy due to adverse events.
Hos kvinder med en prævalent rygsøjlefraktur ved baseline reducerede Fablyn signifikant forekomsten af nye radiografisk verificerede rygsøjlefrakturer fra 14,2 % for placebo til 8,7 % for Fablyn (relativ reduktion af risiko = 42%, p = 0,0004). 
In women with a prevalent vertebral fracture at baseline, FABLYN significantly reduced the incidence of new vertebral radiographic fractures from 14.2% for placebo to 8.7% for FABLYN (relative risk reduction = 42%, p = 0.0004).
Hos kvinder uden prævalent rygsøjlefraktur ved baseline var forekomsten af nye radiografisk verificerede rygsøjlefrakturer signifikant reduceret fra 7,4 % for placebo til 4,4% for Fablyn (relativ reduktion af risiko = 41 %, p = 0,0002). 
In women without any prevalent vertebral fractures at baseline, the incidence of new radiographic vertebral fractures was significantly reduced from 7.4% for placebo to 4.4% for FABLYN (relative risk reduction = 41%, p = 0.0002).
• Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her. 
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Disse cystiske fund medførte en forøgelse af den gennemsnitlige endometrietykkelse på ca. 1,5 mm. Som følge af disse benigne påvirkninger fik flere Fablyn-behandlede end placebo-behandlede patienter foretaget en diagnostisk undersøgelse af uterus under PEARL-studiet (se pkt. 
As a consequence of these benign effects, more FABLYN-treated patients had a diagnostic uterine procedure compared to placebo-treated patients in the PEARL trial (see section 5.1).
• På baggrund af de kliniske studier er de morfologiske forandringer, forårsaget af FABLYN, 
• Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs.
Sjælden: Bronkitis, cellulitis, cervicitis, diverticulit, furunculus, genital candidiasis, herpes simplex, 
Arthritis infective, bronchitis, cellulitis, cervicitis, diverticulitis, fungal infection, furuncle, genital candidiasis, herpes simplex ophthalmic, impetigo, labyrinthitis,
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER - 7 tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 7 tablets
Sjælden: Kronisk obstruktiv lungesygdom, lungegranulom, vasomotorisk rinit Mave-tarm-kanalen 
Chronic obstructive pulmonary disease, pulmonary granuloma, vasomotor rhinitis Gastrointestinal disorders
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER - 30 tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 30 tablets
• hvis De ikke har mulighed for at bevæge Dem i et stykke tid, som f.eks. hvis De skal indlægges, eller hvis De skal ligge i sengen efter en operation eller en sygdom. 
• if you are immobile for some time, such as, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an illness, as these may increase your risk of blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
Fablyn må ikke anvendes til kvinder i den fødedygtige alder (se pkt. 
FABLYN must not be taken by women of childbearing potential (see section 4.3).
Sjælden: Artropati, bursitis, coccygodyni, costochondritis, dactylitis, exostose, hæmartrose, kontraktur af ekstremitet, ledstivhed, muskelkontraktur, muskeltrækninger, muskuloskeletale gener, periartrit, rheumatoid artrit, rotator cuff-syndrom, smerter i kæbe, tendosynovitis, trommestikfingre Nyrer og urinveje Ikke almindelig: 
Arthropathy, bursitis, clubbing, coccydynia, costochondritis, dactylitis, exostosis, extremity contracture, haemarthrosis, joint stiffness, muscle contracture, muscle twitching, musculoskeletal discomfort, pain in jaw, periarthritis, rheumatoid arthritis,
Sjælden: Abnorm EKG T-bølge, abnormt fund ved røntgen af thorax, abnorm serumkreatinin, abnorm ultralydsundersøgelse af bryst, abnorm ultralydsundersøgelse af ovarier blod i urinen, forhøjet 5′-nukleotidase, forhøjet gamma-glutamyltransferase, forhøjet low density lipoprotein, forhøjede serumtriglycerider, nedsat fodpuls, nedsat high density lipoprotein, nedsat knogletæthed, nedsat serumalbumin, nedsat trombocyttal, positiv test for hepatitis Boverfladeantigen, 
5′ nucleotidase increased, blood albumin decreased, blood creatinine abnormal, blood triglycerides increased, blood urine present, bone density decreased, chest X-ray abnormal, electrocardiogram T wave abnormal, gamma-glutamyltransferase increased, hepatitis B surface antigen positive, high density lipoprotein decreased, low density lipoprotein increased, pedal pulse decreased, platelet count decreased, ultrasound breast
LÆGEMIDLETS NAVN FABLYN 500 mikrogram Filmovertrukne tabletter. 
NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) FABLYN 500 mikrogram filmovertrukne tabletter lasofoxifen 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION FABLYN 500 microgram film-coated tablets lasofoxifene
Fortsæt blot med den sædvanlige dosis. 
Take your next tablet and continue as before.
Vaginal candidiasis, vaginal infektion, vulvovaginitis, urinvejsinfektion, 
Uncommon: Urinary tract infection, vaginal candidiasis, vaginal infection, vulvovaginitis Rare:
• Ubehag i brystet, brystsmerter, blødning fra skeden, kløe i kønsorganerne 
• Breast stiffening, breast pain, vaginal bleeding, genital itching
• Sjældne bivirkninger: Forekommer hos mellem 1 og 10 ud af 10.000 patienter 
• Rare: affects 1 to 10 users in 10,000
Nye radiografisk verificerede rygsøjlefrakturer Procentdel af patienter med nye frakturer n=2748 
New radiographic vertebral fractures Percentage of patients with new fracture n=2,748
Metabolisme og ernæring 
Pregnancy and breast-feeding
Protonpumpehæmmere - Der findes ikke oplysninger om samtidig brug af protonpumpehæmmere og lasofoxifen. 
Proton pump inhibitors - Data on the effect of concomitant administration of proton pump inhibitors (PPIs) with lasofoxifene is not available; thus, use of these agents with lasofoxifene should be considered with caution.
Der er ikke foretaget undersøgelser på personer med svær leverinsufficiens (se pkt. 
Subjects with severe hepatic impairment have not been studied (see section 4.4).