natgillin/translations-raw huggingface dataset:
Lasofoxifen undergår omfattende metabolisme i mennesker. 
Lasofoxifene is extensively metabolized in humans.
Kvinderne i dette studie var i gennemsnit 63 år (interval 44 til 79) og i gennemsnit var der gået 13 år siden menopausen. 
Women in this study had a median age of 63 years (range 44 to 79) and a median time since menopause of 13 years.
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. 
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.
Lasofoxifens biotransformation og disposition i mennesker er bestemt ved oral administration af 14C 
Biotransformation and disposition of lasofoxifene in humans have been determined following oral administration of 14C-labeled lasofoxifene.
Der er ikke rapporteret tilfælde af overdosering med Fablyn. 
No case of FABLYN overdose has been reported.
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. 
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.
Alle uforklarede mammaforandringer, opstået under Fablyn-behandling, bør undersøges. 
Any unexplained breast abnormality occurring during FABLYN therapy should be investigated.
Patologen skal informeres om patientens brug af lasofoxifen ved vurdering af endometriehistology for at sikre en præcis diagnose af benign cystisk atrofi. 
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.
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. 
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.
Fald i østrogenniveau efter menopause eller ooforektomi fører til accelereret knogletab på grund af forøget knogleomsætning, hvor knogleresorption overstiger knogledannelse. 
Decreases in estrogen levels after menopause or oophorectomy lead to accelerated bone loss due to increased bone turnover, where bone resorption exceeds bone formation.
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). 
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).
Fablyn øgede også signifikant helkrops-knoglemineralindholdet (BMC) sammenlignet med placebo efter 3 år. 
FABLYN also significantly increased whole body bone mineral content (BMC), compared to placebo, at 3 years.
Paroxetin - Den stærke CYP2D6-inhibitor paroxetin øger den systemiske eksponering for lasofoxifen med 35 %, hvilket ikke vurderes at være klinisk relevant. 
Paroxetine - The strong CYP2D6 inhibitor paroxetine increased the systemic exposure of lasofoxifene by 35% which is not considered to be clinically meaningful.
Alle kvinder i studiet fik calcium (600-1200 mg dagligt) og vitamin D (400800 IU dagligt). 
All women in the study received calcium (600-1200 mg/day) and Vitamin D (400-800 IU/day).
Hos patienter med dette i anamnesen bør niveauet af triglycerider i serum monitoreres under behandlingen med lasofoxifen. 
Patients with this medical history should have serum triglycerides monitored when taking lasofoxifene.
Tal med lægen, inden De begynder at tage FABLYN, hvis: 
You should talk to your doctor before starting to take FABLYN:
Lasofoxifens halveringstid hos postmenopausale kvinder er ca. 6 dage ved steady state, hvilket giver små koncentrationsudsving over doseringsintervallet på 24 timer. 
At steady state, the half-life of lasofoxifene in postmenopausal women is approximately 6 days, resulting in small fluctuations in concentrations over the 24-hour dosing interval.
Blisterpakninger med 7, 28 eller 30 tabletter og beholdere med 90 tabletter. 
Blister packs of 7, 28 or 30 tablets and bottles of 90 tablets.
Fablyn må kun anvendes til postmenopausale kvinder. 
FABLYN is only for use in postmenopausal women.
Brug af FABLYN sammen med mad og drikke FABLYN kan tages med eller uden mad og drikke. 
FABLYN can be taken with or without food and drink.
Lasofoxifen har vævs- og cellespecifikke virkninger i østrogen-responsivt væv. 
Lasofoxifene produces tissue and cell-specific effects in estrogen-responsive tissues.
Alle kvinder i studiet fik calcium (1000 mg dagligt) og vitamin D (400-800 IU dagligt). 
All women in the study received calcium (1,000 mg/day) and Vitamin D (400-800 IU/day).
Placebobehandlede kvinder havde en forekomst af cystiske forandringer på 1,9 % over 3 år, mens Fablyn-behandlede kvinder havde en forekomst på 20,4 %. 
Placebo-treated women had a 1.9% incidence in cystic change over 3 years, whereas the FABLYNtreated women had a 20.4% incidence.
Det er ikke normalt, at FABLYN giver blødning fra skeden. 
It is unlikely that FABLYN will cause vaginal bleeding.
Der var ingen tegn på osteomalaci, knoglemarvsfibrose, cellulær toksicitet, woven bone eller andre abnormiteter, som kunne påvirke knoglekvaliteten efter lasofoxifen-behandling. 
There was no evidence of osteomalacia, marrow fibrosis, cellular toxicity, woven bone or other abnormalities affecting the quality of the bone following lasofoxifene treatment.
Hvis De har glemt at tage FABLYN 
If you forget to take FABLYN
Behandlingen kan genoptages, så snart De kan bevæge Dem normalt igen og efter aftale med lægen. 
Treatment with FABLYN can be restarted as soon as you regain your mobility and in consultation with your doctor.
• Kraftig sveden 
• Excessive sweating
Lasofoxifen er i høj grad proteinbundet, elimineres hovedsageligt ved metabolisme og indgår sandsynligvis i den enterohepatiske cirkulation (se pkt. 
Lasofoxifene is highly protein bound, predominantly cleared by metabolism and is likely to undergo enterohepatic circulation (see section 5.2).
Se indlægssedlen for yderligere information. 
Contains lactose See the package leaflet for further information.
I kliniske studier ændrede lasofoxifen ikke metaboliseringen af dextromethorphan (CYP2D6-substrat) og chlorzoxazon (CYP2E1-substrat) eller farmakokinetikken af warfarin (CYP2C9-substrat), methylprednisolon (CYP3A4-substrat) eller digoxin (MDR1 P-glycoproteinsubstrat). 
In clinical studies, lasofoxifene did not alter the metabolism of dextromethorphan (CYP2D6 substrate) and chlorzoxazone (CYP2E1 substrate) or the pharmacokinetics of warfarin (CYP2C9 substrate), methylprednisolone (CYP3A4 substrate) or digoxin (MDR1 P-glycoprotein substrate).
Lasofoxifens steady state-farmakokinetik stemmer overens med, hvad der kunne forventes ud fra enkeltdosis-farmakokinetikken. 
Steady-state pharmacokinetics of lasofoxifene are consistent with expectations from its single-dose pharmacokinetics.
• De anbefalede tiltag for at nedsætte risikoen for venøs tromboemboli baseret på produktresuméet, 
• The approaches recommended for mitigation of risk of venous thromboembolism based on the
Der blev udført flere diagnostiske uterine procedurer på Fablyn-behandlede patienter som følge af vaginal blødning (som beskrevet i protokollen) og asymptomatiske endometriefund (f.eks. mistanke om uteruspolypper, endometrietykkelse). 
Diagnostic uterine procedures were performed in a greater number of FABLYN-treated patients as a result of vaginal bleeding (as mandated by the protocol) and asymptomatic endometrial findings (e.g., suspected uterine polyps, endometrial thickness).
Ældre: 
Elderly:
Kvinderne i dette studie var i gennemsnit 67 år (interval 59 til 80) og i gennemsnit var der gået 20 år siden menopausen. 
Women enrolled in this study had a median age of 67 years (range 59 to 80) and a median time since menopause of 20 years.
Lasofoxifen og dets metabolitter udskilles primært i fæces med kun en mindre del af det lasofoxifen-relaterede materiale udskilt i urinen. 
Lasofoxifene and its metabolites are primarily excreted in feces, with a minor component of urinary excretion of active substance-related material.
Flere Fablyn-behandlede patienter (7,0 %) end placebobehandlede patienter (2,7 %) fik foretaget en diagnostisk procedure. 
More FABLYN-treated patients (7.0%) had a diagnostic procedure compared to placebo-treated patients (2.7%).
Disse bivirkninger kan forekomme som vist nedenfor: 
These side effects may occur with certain frequencies, which are defined as follows:
• Øvrige indholdsstoffer: vandfrit lactose; mikrokrystalliseret cellulose; croscarmellose natrium; silica; kolloid vandfri silica; magnesiumstearat; sunset yellow FCF (E110); hypromellose; lactosemonohydrat; titandioxid (E171)og triacetin. 
• The other ingredients are lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica, colloidal anhydrous; magnesium stearate; sunset yellow FCF aluminium lake (E110); hypromellose; lactose monohydrate; titanium dioxide (E171) and triacetin.
• Træthed, unormal eller kraftig blødning, som oftest fra næsen 
• Tiredness, abnormal or excessive bleeding commonly from the nose
Tabletterne findes i blisterpakninger med 7, 28 eller 30 tabletter, og i beholder med 90 tabletter. 
The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing 90 tablets.
Placebobehandlede kvinder havde et fald i den gennemsnitlige endometrietykkelse på 0,7 mm fra baseline over 3 år, mens Fablyn-behandlede kvinder havde en gennemsnitlig stigning på 1,4 mm. 
Placebo-treated women had a 0.7 mm mean decrease from baseline in endometrial thickness over 3 years, whereas the FABLYN-treated women had a 1.4 mm mean increase.
Lasofoxifen blev undersøgt som en enkeltdosis på 0,25 mg hos raske frivillige og frivillige med mild eller moderat leverinsufficiens. 
Lasofoxifene was studied, as a single 0.25 mg dose, in healthy subjects and subjects with mild or moderate hepatic impairment.
Lasofoxifen udviser lineær farmakokinetik over et bredt dosisområde efter administration af enkeltdosis (op til 100 mg) og flerdosis (op til 20 mg en gang dagligt). 
Lasofoxifene exhibits linear pharmacokinetics over a wide dose range following single-dose (up to 100 mg) and multiple-dose (up to 20 mg once daily) administration.
Virkninger på brystvæv: 
Effects on breast:
Ketoconazol - Den stærke CYP3A4/5-inhibitor ketoconazol øger den systemiske eksponering for lasofoxifen med 20 %, hvilket ikke vurderes at være klinisk relevant. 
Ketoconazole - The strong CYP3A4/5 inhibitor ketoconazole increased the systemic exposure of lasofoxifene by 20% which is not considered to be clinically meaningful.
• hvis De har eller har haft blodpropper, f.eks. i blodåre, lunger eller øjne (blodprop i benene, 
• if you currently have or previously had blood clots, for example in your veins, lungs or eyes
I det samme studie var der efter 5 år ingen stigning i risikoen for apopleksi, herunder hæmoragisk, iskæmisk, embolisk apopleksi, ikke-specificeret apopleksi og transitorisk iskæmisk hændelse hos Fablyn-behandlede patienter. 
In the same study at 5 years, there was no increase in the risk of stroke including hemorrhagic, ischemic, embolic stroke, stroke type unspecified and transient ischemic attacks in FABLYN-treated patients.
Fablyn eliminerer ikke risikoen for mammacancer (se pkt. 
FABLYN does not eliminate the risk of breast cancer (see section 5.1).
• hvis De har blødning fra skeden. 
• if you have any vaginal bleeding.
Der er fundet tre metabolitter af lasofoxifen i plasma: det direkte glucuronidkonjugat, glucuronid af en hydroxyleret metabolit og methyleret catechol. 
Three metabolites of lasofoxifene were detected in plasma: the direct glucuronide conjugate, the glucuronide of a hydroxylated metabolite, and the methylated catechol.
Trekantede, ferskenfarvede filmovertrukne tabletter præget med “Pfizer” på den ene side og “OPR 05” på den anden side. 
Triangular, peach-coloured, film-coated tablets debossed with “Pfizer” on one side and “OPR 05” on the other side.
Fablyn påvirker ikke risikoen for østrogenreceptor-negativ mammacancer eller østrogenreceptor-negativ invasiv mammacancer. 
FABLYN has no effect on the risk of ER negative breast cancer or ER negative invasive breast cancers.
• Hævede hænder, arme, fødder eller ben, bensmerter 
• Swelling of hands, arms, feet or legs, limb pain
Nye radiografisk verificerede rygsøjlefrakturer hos patienter med ≥ 1 baseline-fraktur 
New radiographic vertebral fracture in patients with ≥ 1 baseline fracture
I osteoporose-studierne resulterede Fablyn-behandling i en konstant, statistisk signifikant hæmning af knogleresorption og knogledannelse, afspejlet i ændringer i serum- og urinindholdet af knogleomsætningsmarkører (f.eks. C-telopeptid og knogledannelsesmarkører: osteocalcin, procollagen type 1 N-terminal propeptid og knoglespecifik alkalisk fosfatase). 
In the osteoporosis treatment trials, FABLYN therapy resulted in consistent, statistically significant suppression of bone resorption and bone formation, as reflected by changes in serum and urine markers of bone turnover (e.g., C-telopeptide and markers of bone formation: osteocalcin, procollagen type 1 N-terminal propeptide, and bone-specific alkaline phosphatase).
I et 3-års substudie under PEARL-studiet (n=760) forøgede Fablyn signifikant BMD (sammenlignet med placebo) i lænderygsøjle (3,3 %), total hofte (3,0 %), lårbenshals (3,3 %), trochanter major (3,6 %), intertrochantær-område (2,6 %), Wards trekant (5,9 %) og underarm (1,8 %) efter 3 år. 
In a 3-year substudy of the PEARL study (n=760), FABLYN significantly increased BMD (compared to placebo) at lumbar spine (3.3%), total hip (3.0%), femoral neck (3.3%), greater trochanter (3.6%), intertrochanteric area (2.6%), Ward's triangle (5.9%) and forearm (1.8%) at 3 years.
Fablyn filmovertrukne tabletter findes i PVC-blisterpakninger med aluminumsfolie eller i HDPEbeholdere med børnesikret polypropylenlåg, der er beklædt med polyethylen/aluminumsfolie. 
FABLYN film-coated tablets are supplied in PVC blisters with aluminum foil backing or HDPE bottles with polyethylene/aluminum foil lined polypropylene child-resistant closures.
Dette medfører en forøgelse af den gennemsnitlige endometrietykkelse. 
It results in increased mean endometrial thickness.
Der findes ingen oplysninger om samtidig brug af Fablyn og midler mod tidlig eller fremskreden mammacancer. 
No data are available on its concomitant use with agents used in the treatment of early or advanced breast cancer.
Plasmaindholdet af lasofoxifen var omtrent det samme hos raske frivillige som hos frivillige med mild leverinsufficiens (Child-Pugh Class A) og moderat øget (38 %) hos frivillige med moderat leverinsufficiens (Child-Pugh Class B) sammenlignet med raske frivillige. 
Plasma lasofoxifene exposure was approximately the same in healthy subjects as in subjects with mild hepatic impairment (Child-Pugh Class A) and was modestly increased (38%) in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to healthy subjects.
Gennem 5 års follow-up fik 37 Fablyn-behandlede kvinder (1,3 % eller 2,90 pr. 1000 patientår) VTE sammenlignet med 18 placebobehandlede kvinder (0,6 % eller 1,41 pr. 1000 patientår) og hazard ratio var 2,06 (95 % CI: 1,17; 3,61). 
Through 5 years of follow-up, 37 FABLYN-treated women (1.3%, or 2.90 per 1,000 patients years) had a VTE compared to 18 placebo-treated women (0.6%, or 1.41 per 1,000 patients years) and the hazard ratio was 2.06 (95% CI: 1.17, 3.61).
I en undergruppe af studiepopulationen, designet til at undersøge endometriehistologi (1080 patienter) ved en TVU efter 3 år, blev der fundet histologisk benigne endometriepolypper hos 20 af 366 (5,5 %) Fablynbehandlede kvinder og hos 12 af 360 (3,3 %) placebobehandlede kvinder. 
In a subset of the study population designed to look at endometrial histology (1,080 patients) with a TVU at 3 years, histologically benign endometrial polyps were reported in 20 of 366 (5.5%) FABLYN-treated women and 12 of 360 (3.3%) placebo-treated women.
Signifikant færre Fablyn-behandlede kvinder fik moderate eller alvorlige rygsøjlefrakturer (bestemt ved Genant-skala) sammenlignet med placebobehandlede kvinder (5,2 % placebobehandlede kvinder versus 3,3 % Fablyn-behandlede kvinder; p = 0,0006). 
Significantly fewer women treated with FABLYN experienced moderate or severe vertebral fractures (as determined by the Genant scale) compared to women treated with placebo (5.2% placebo-treated women versus 3.3% FABLYN-treated women; p = 0.0006).
Clearance af lasofoxifen kan være øget hos patienter i kronisk behandling med inducere af CYP3A4 og UGT-enzymer (f.eks. phenytoin, carbamazepin, barbiturater og perikum), hvilket vil resultere i lavere steady state-koncentrationer og potentielt nedsat effekt. 
Lasofoxifene clearance may be increased in patients chronically treated with inducers of CYP3A4 and UGTs (eg, phenytoin, carbamazepine, barbiturates and St John's Wort) resulting in reduced steadystate concentrations and may result in reduced efficacy.
Sammenlignet med placebo nedsatte Fablyn-behandling risikoen for invasiv mammacancer med 85 % (placebo: 20 (0,7 %), Fablyn: 3 (0,1 %); HR 0,15 (CI 0,04; 0,50)), risikoen for alle typer af mammacancer med 79 % (placebo: 24 (0,9 %), Fablyn: 5 (0,2 %); HR 0,21 (CI 0,08; 0,55)), risikoen for østrogenreceptor-positiv invasiv mammacancer med 83 % (placebo: 18 (0,7 %), Fablyn: 3 (0,1 %); HR 0,17 (CI 0,05; 0,57)) og risikoen for østrogenreceptor-positiv mammacancer med 81 % (placebo: 21 (0,8 %), Fablyn: 4 (0,1 %); HR 0,19 (CI 0,07; 0,56)). 
Over the 5 years of the PEARL study (involving 8,556 patients), FABLYN treatment compared to placebo reduced the risk of invasive breast cancer by 85% (placebo: 20 (0.7%), FABLYN: 3 (0.1%); HR 0.15 (CI 0.04, 0.50)), the risk of all breast cancer by 79% (placebo: 24 (0.9%), FABLYN: 5 (0.2%); HR 0.21 (CI 0.08, 0.55)), the risk of estrogen receptor (ER) positive invasive breast cancer by 83% (placebo: 18 (0.7%), FABLYN: 3 (0.1%); HR 0.17 (CI 0.05, 0.57)) and the risk of estrogen receptor (ER) positive breast cancer by 81% (placebo: 21 (0.8%), FABLYN: 4 (0.1%); HR 0.19 (CI 0.07, 0.56)).
Der er ikke observeret nogen klinisk betydende ændringer i lasofoxifens farmakokinetik i aldersgruppen 40 til 80 år i en farmakokinetisk populationsanalyse. 
No clinically meaningful differences in lasofoxifene pharmacokinetic were observed over the age range of 40 to 80 years of age based on the results of a population pharmacokinetic analysis.
I alt 2852 personer blev randomiseret til Fablyn og 2852 til placebo. 
The duration of treatment in postmenopausal women was 60 months, 2,852 were randomized to FABLYN and 2,852 were randomized to placebo.
Dosisjustering er ikke nødvendig hos ældre kvindelige patienter (se pkt. 
No dose adjustment is necessary in elderly female patients (see section 5.2).
• Brændende fornemmelse, svimmelhed, følelsesløshed, hukommelsestab, nedsat eller delvis nedsat bevægelighed af lemmerne, hovedpine, uro i benene (en uimodståelig trang til at bevæge benene for at stoppe en ubehagelig eller mærkelig fornemmelse i benet) 
• Burning sensation, dizziness, numbness, memory impairment, impaired or partial loss of movement of a limb, headache, restless legs syndrome (an irresistible urge to move legs to stop an uncomfortable or odd sensations)
Fablyns virkning på knoglevæv viser sig ved reduktion af serumog urinindholdet af knogleomsætningsmarkører, forøgelse af knoglemineraldensiteten (BMD) samt nedsat forekomst af frakturer. 
The effects of FABLYN on bone are manifested as reductions in the serum and urine levels of bone turnover markers, increases in bone mineral density (BMD), and decreases in incidence of fractures.
* Endometriehypertrofi er en MedDRA-term, som betegner endometrietykkelse påvist ved ultralyd. 
* Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings.
Hos kvinder med en uterus ved baseline blev der fundet histologisk benigne endometriepolypper hos 34 af 2302 (1,5 %) Fablyn-behandlede kvinder versus 18 af 2309 (0,8 %) placebobehandlede kvinder. 
In all women with a uterus at baseline, histologically benign endometrial polyps were reported in 34 of 2,302 (1.5%) FABLYN-treated women versus 18 of 2,309 (0.8%) placebo-treated women.
Risk-benefit bør vurderes for patienter med risiko for venøse tromboemboliske hændelser af enhver ætiologi (se pkt. 
The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology (see sections 4.3 and 4.8).
Der er identificeret fem metaboliske pathways for lasofoxifen: direkte glucuronidation; direkte sulfonering; hydroxylering af phenyltetralin-delen (med efterfølgende konjugerende metabolisme af catechol-intermediaterne ved metylering og glucuronidation); oxidering af pyrrolidinringen; og phenylhydroxylering. 
Five metabolic pathways of lasofoxifene have been identified: direct glucuronidation; direct sulfation; hydroxylation at the phenyl tetraline moiety (with subsequent conjugative metabolism of the catechol intermediates by methylation and glucuronidation); oxidation at the pyrrolidine ring; and phenyl hydroxylation.
I den tilsvarende 2-års undersøgelse på mus (≥2 mg/kg/dag; mindre end den systemiske eksponering efter en human dosis på 0,5 mg/dag baseret på plasma-AUC) sås en øget forekomst af adrenokorticale adenomer og carcinomer, interstitielle celletumorer i testes, benigne og maligne ovarietumorer og benigne uterine glandulære polypper. 
In the corresponding 2-year study in mice (≥2 mg/kg/day; less than systemic exposure following a human dose of 0.5 mg/day based on plasma AUC), there was an increased incidence of adrenal cortical adenoma and carcinoma, interstitial cell tumors of the testis, benign and malignant ovarian tumors and benign uterine glandular polyps.
Lasofoxifens fordelingsvolumen hos postmenopausale kvinder er ca. 1350 l. 
The apparent volume of distribution (V/F) of lasofoxifene in postmenopausal women is approximately 1,350 l.
• Betændelse i øret, øjet, halsen eller huden, diarré, blod i afføringen 
• Infection in the ear, eye, respiratory tract or skin, diarrhea, blood in stools
• BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
Lasofoxifen kan være forbundet med benigne endometrielle virkninger: cystiske endometrieforandringer set ved ultralydsundersøgelser og histologisk påvist benign cystisk atrofi (en variant af atrofisk endometrium), der medfører en forøgelse af den gennemsnitlige endometrietykkelse på ca. 1,5 mm. 
Lasofoxifene may be associated with benign endometrial effects: endometrial cystic change viewed on ultrasound and histological benign cystic atrophy (a variant of atrophic endometrium), contributing to approximately 1.5 mm increase in mean endometrial thickness.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 24 February 2009
Procentdel af patienter med nye frakturer n=778 
Percentage of patients with new fracture n=778
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 90 filmovertrukne tabletter 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 90 film-coated tablets