natgillin/translations-raw huggingface dataset:
The increased turnover causes accelerated bone loss because the compensatory increase in bone formation is not sufficient to offset increased bone resorption. 
Zvečana premena povzroči pospešeno izgubo kosti, ker kompenzacijsko zvečano nastajanje kosti ne zadošča za nadomeščanje zvečane resorpcije kosti.
WHAT FABLYN IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO FABLYN IN ZA KAJ GA UPORABLJAMO
The study population consisted of 497 women with osteoporosis as defined by low vertebral BMD (T-score ≤ 2.5). 
Populacijo študije je sestavljalo 497 žensk z osteoporozo, definirano z majhno BMD vretenc (T-vrednost ≤ 2,5).
Women in this study had a median age of 63 years (range 44 to 79) and a median time since menopause of 13 years. 
Mediana starost žensk v tej študiji je bila 63 let (razpon 44 do 79), mediani čas od menopavze pa 13 let.
Since less than 2% of lasofoxifene is recovered in urine as unchanged active substance, a study in subjects with renal insufficiency was not conducted. 
Ker se v urinu pojavi manj kot 2 % lasofoksifena v obliki nespremenjene zdravilne učinkovine, pri osebah z insuficienco ledvic niso opravili nobene študije.
Pregnancy and lactation: FABLYN is only for use in postmenopausal women. 
Nosečnost in dojenje: Zdravilo FABLYN se uporablja samo pri ženskah v postmenopavzi.
The number of subjects discontinuing treatment as a result of vaginal bleeding was low [FABLYN: 4 (0.1%), placebo: 0]. 
Število oseb v preiskavi, ki so prekinile zdravljenje zaradi vaginalnih krvavitev, je bilo majhno [zdravilo FABLYN: 4 (0,1 %), placebo: 0].
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
-Radiographic vertebral fractures 
-Rentgensko ugotovljeni vretenčni zlomi
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). 
Lasofoksifen ni bil teratogen pri podganah do odmerka10 mg/kg (AUC, približno 53-krat večja kot pri ljudeh) niti pri kuncih do odmerka 3 mg/kg (pod ravnjo sistemske izpostavljenosti pri ljudeh).
In some cases, these findings were observed to resolve spontaneously on treatment. 
V nekaterih primerih so opazili, da so te spremembe po zdravljenju same od sebe izginile.
These observations support the conclusion that lasofoxifene has no intrinsic estrogen agonist activity in breast tissue. 
Te ugotovitve podpirajo sklep, da lasofoksifen v tkivu dojke nima intrinzične estrogenske agonistične aktivnosti.
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. 
Zato ni verjetno, da bi zdravilo FABLYN spreminjalo farmakokinetiko zdravil, ki se presnavljajo preko izoform CYP ali se prenašajo preko P-glikoproteina MDR1.
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). 
Razmerje med tveganjem in koristjo moramo pretehtati pri bolnicah, ki jih ogrožajo venski trombembolični dogodki ne glede na etiologijo (glejte poglavji 4.3 in 4.8).
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). 
Po peroralnem dajanju lasofoksifena v raztopini, označenega s 14C so v naslednjih 24 dneh prestregli približno 72 % radioaktivnega odmerka (približno 66 % v blatu in 6 % v urinu).
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). 
Statistično signifikantno zvišanje so ugotovili pri apolipoproteinu A-1, ki je povezan s HDL holesterolom, in serumskih trigliceridih (mediane spremembe glede na placebo 6,1 % oziroma 4,9 %).
Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Germany. 
Imetnik dovoljenja za promet z zdravilom je Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Nemčija.
The safety of FABLYN in the treatment of osteoporosis was also assessed in a Phase 2 placebocontrolled trial in Japanese, Korean and Taiwanese women. 
Varnost zdravila FABLYN za zdravljenje osteoporoze so ocenili tudi v preskušanju faze 2, kontroliranem s placebom, pri Japonkah, Korejkah in Tajvankah.
Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. 
Če je dnevni vnos kalcija in/ali vitamina D nezadosten, ju bo treba dodajati prehrani.
FABLYN may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with estrogen deficiency. 
Zdravilo FABLYN lahko zveča pogostnost vročinskih oblivov in ne zmanjšuje pogostnosti vročinskih oblivov, povezanih s pomanjkanjem estrogenov.
Infections and infestations 
Infekcije in parazitske bolezni
The number of hysterectomies in the FABLYN-treated group (27/2,302 patients, 1.2%) and the placebo-treated group (24/2,309 patients, 1.0%) were similar. 
Število histerektomij v skupini, zdravljeni z zdravilom FABLYN (27/2.302 bolnic, 1,2 %), in v skupini, ki je jemala placebo (24/2.309 bolnic, 1,0 %), je bilo podobno.
• The active substance is lasofoxifene. 
• Zdravilna učinkovina je lasofoksifen.
Lasofoxifene has been associated with benign endometrial effects. 
Lasofoksifen je bil povezan z benignimi učinki na endometrij.
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. 
Inhibitorji protonske črpalke - Podatkov o vplivu sočasnega jemanja inhibitorjev protonske črpalke (PPI) z lasofoksifenom ni na voljo; zato je pri uporabi teh zdravil z lasofoksifenom potrebna previdnost.
Subjects with severe hepatic impairment have not been studied (see section 4.4). 
Oseb s težko okvaro jeter niso proučevali (glejte poglavje 4.4).
These cystic findings contributed to an approximate 1.5 mm increase in mean endometrial thickness. 
Cistične spremembe so prispevale k približno 1,5-milimetrskem zvečanju povprečne debeline endometrija.
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)). 
V 5 letih študije PEARL (ki je zajelo 8.556 bolnic) je zdravljenje z zdravilom FABLYN v primerjavi s placebom zmanjšalo tveganje invazivnega raka dojke za 85 % (placebo: 20 (0,7%), FABLYN: 3 (0,1%); HR 0,15 (CI 0,04, 0,50)), tveganje raka dojke ne glede na vrsto raka za 79 % (placebo: 24 (0,9%), FABLYN: 5 (0,2%); HR 0,21 (CI 0,08, 0,55)), tveganje invazivnega raka dojke, pozitivnega na estrogenske receptorje (ER), za 83 % (placebo: 18 (0,7%), FABLYN: 3 (0,1%); HR 0,17 (CI 0,05, 0,57)) in tveganje invazivnega raka dojke, pozitivnega na ER, za 81 % (placebo: 21 (0,8%), FABLYN: 4 (0,1%); HR 0,19 (CI 0,07, 0,56)).
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. 
Pogostnost cističnih sprememb endometrija in zadebelitve endometrija so v obdobju treh let enkrat na leto analizirali v podskupini študijske populacije (298 bolnic) s transvaginalno ultrazvočno preiskavo (TVU).
Elimination: 
Izločanje:
Ingestion of a high fat meal does not change the oral bioavailability of lasofoxifene. 
Zaužitje zelo mastnega obroka ne spremeni peroralne biološke uporabnosti lasofoksifena.
The increase was observed at 12 months, and did not significantly increase through 3 years. 
Zvečanje so opazili po 12 mesecih in nato do konca triletnega obdobja ni več naraščalo.
Lasofoxifene binds to both albumin and α1-acid glycoprotein; however, it does not affect the binding of either warfarin or propranolol. 
Lasofoksifen se veže tako na albumin kot na α1-kisli glikoprotein; vendar pa ne vpliva na vezavo niti varfarina niti propranolola.
Animal studies have shown excretion of lasofoxifene in milk. 
Študije na živalih so pokazale, da se lasofoksifen izloča v mleko.
• When new information is received that may impact on the current Safety Specification, 
• kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolnice z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze tega zdravila ne smejo jemati
• Abnormal dreams, mood swings 
• nenormalne sanje, nihanje razpoloženja;
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. 
Učinke zdravila FABLYN na BMD pri Japonkah, Korejkah in Tajvankah v postmenopavzi z osteoporozo so raziskali tudi v enoletnem randomiziranem dvojno slepem preskušanju zdravljenja osteoporoze, kontrolirani s placebom.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK
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. 
Lasofoksifen so dajali ženskam v postmenopavzi v enkratnih odmerkih do 100 mg (200-krat večjih od priporočenega enkratnega odmerka) in večkratnih odmerkih, velikih do 10 mg/dan (kar je 20-krat več od priporočenega odmerka) do enega leta dolgo brez resnih neželenih učinkov, povezanih z odmerkom.
It is unlikely that FABLYN will cause vaginal bleeding. 
Ni verjetno, da bi zdravilo FABLYN povzročilo krvavitev iz nožnice.
Clinical data indicate that FABLYN has an estrogen-like agonist effect on bone as well as antagonistic effects on the breast. 
Klinični podatki kažejo, da ima zdravilo FABLYN estrogenu podobno agonistično delovanje na kost, pa tudi antagonistično delovanje na dojko.
• FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium. 
o Zdravilo FABLYN povzroča morfološke spremembe, še posebno cistično atrofijo endometrija.
Lasofoxifene is highly protein bound, predominantly cleared by metabolism and is likely to undergo enterohepatic circulation (see section 5.2). 
Lasofoksifen se močno veže na proteine in se pretežno presnavlja ter je verjetno vključen v enterohepatično cirkulacijo (glejte poglavje 5.2).
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. 
V stanju dinamičnega ravnovesja znaša razpolovni čas lasofoksifena pri ženskah v postmenopavzi približno 6 dni, kar pri 24-urnem presledku med odmerki povzroča majhna nihanja koncentracij.
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. 
Sočasne uporabe zdravila FABLYN in sistemskega estrogenskega ali hormonskega zdravljenja niso preučili, zato sočasna uporaba zdravila FABLYN s sistemskimi estrogeni ni priporočljiva.
The duration of treatment in postmenopausal women was 60 months, 2,852 were randomized to FABLYN and 2,852 were randomized to placebo. 
Zdravljenje žensk v postmenopavzi je trajalo 60 mesecev, 2.852 jih je bilo randomiziranih na zdravilo FABLYN, 2.852 pa na placebo.
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. 
Omejeni klinični podatki kažejo, da je pri bolnicah s hipertrigliceridemijo (> 5,6 mmol/l) v ananmezi, povzročeno s peroralnim estrogenom, lasofoksifen povezan z občutnim zvišanjem serumskih trigliceridov.
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. 
V prenatalni in postnatalni študiji na podganah je lasofoksifen v odmerkih ≥0,01 mg/kg/dan odložil in/ali zaustavil skotitev, zvečal smrtnost mladičev ob skotitvi, spremenil doseganje razvojnih mejnikov in zmanjšal rast.
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. 
Učinke zdravila FABLYN na pogostnost zlomov (preglednica 2) so raziskovali 5 let; BMD in kostne biooznačevalce pri ženskah v postmenopavzi z osteoporozo so proučevali 3 leta v študiji PEARL.
Lasofoxifene produces tissue and cell-specific effects in estrogen-responsive tissues. 
Lasofoksifen povzroča tkivne in celično specifične učinke v tkivih, odzivnih na estrogen.
Lasofoxifene and its metabolites are primarily excreted in feces, with a minor component of urinary excretion of active substance-related material. 
Lasofoksifen in njegovi presnovki se izločajo predvsem z blatom, manjši del z zdravilno učinkovino povezanih snovi pa se izloča z urinom.
In this study, FABLYN significantly increased spine and hip (total hip and all subcomponents of the hip) BMD by 2 to 4%. 
V tej študiji je zdravilo FABLYN signifikantno zvečalo BMD hrbtenice in kolka (kolka kot celote in vseh sestavnih delov kolka) za 2 do 4 %.
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). 
Varnost zdravila FABLYN za zdravljenje osteoporoze so ocenjevali v veliki (8.556 bolnic), dvojno slepi, randomizirani multinacionalni študiji kostnih zlomov faze III, kontrolirani s placebom (študija PEARL).
FABLYN is only for women after the menopause and must not be taken by women who can still become pregnant. 
Zdravilo FABLYN je namenjeno le ženskam v pomenopavzi, ne smejo ga jemati ženske, ki še lahko zanosijo.
• Abnormal or irregular beating of the heart, increased heart rate 
• nenormalno ali nepravilno bitje srca, pospešen srčni utrip;
There is no specific antidote for FABLYN. 
Za zdravilo FABLYN ni specifičnega antidota.
FABLYN has no effect on the risk of ER negative breast cancer or ER negative invasive breast cancers. 
Zdravilo FABLYN ni vplivalo na tveganje ER negativnega ali invazivnega, ER negativnega raka dojke.
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. 
V obeh študijah je zdravilo FABLYN zmanjšalo stopnjo izraženosti najbolj motečega simptoma VVA bolnice ob začetku študije, znižanega nožničnega pH, zmanjšalo odstotni delež vaginalnih parabazalnih celic iz indeksa dozorevanja (MI-maturation index) in zvečalo odstotni delež vaginalnih površinskih celic iz MI.
B. CONDITIONS OF THE MARKETING AUTHORISATION 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Biotransformation and disposition of lasofoxifene in humans have been determined following oral administration of 14C-labeled lasofoxifene. 
Biotransformacijo in odstranjevanje lasofoksifena iz telesa so določili po peroralnem dajanju lasofoksifena, označenega s 14C.
Paroxetine - The strong CYP2D6 inhibitor paroxetine increased the systemic exposure of lasofoxifene by 35% which is not considered to be clinically meaningful. 
Paroksetin - Močni inhibitor CYP2D6 paroksetin je zvečal sistemsko izpostavljenost lasofoksifenu za 35 %, kar ne velja za klinično pomembno.
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). 
Populacijo študije je sestavljalo 8.556 žensk v postmenopavzi z osteoporozo, definirano z zmanjšano BMD (BMD hrbtenice ali kolka vsaj 2,5 standardne deviacije pod povprečno vrednostjo pri zdravih mladih ženskah (T-vrednost)).
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. 
Ker imobilizacija zveča nevarnost venskih trombemboličnih dogodkov ne glede na zdravljenje, je treba zdravilo FABLYN ukiniti najpozneje 3 tedne pred dolgotrajno imobilizacijo in med njo (npr. okrevanje po operaciji, dolgotrajno ležanje v postelji), zdravljenje z zdravilom FABLYN pa smemo znova uvesti šele, ko je bolnica že povsem pokretna.
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. 
Kadar patologi pregledujejo histologijo endometrija, morajo biti seznanjeni z anamnezo jemanja lasofoksifena, da bi zagotovili pravilno diagnozo benigne cistične atrofije, kadar je ta prisotna.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 90 film-coated tablets 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 90 filmsko obloženih tablet
Based on 3- and 5-year human data in the clinical trials, the incidence of cancer during treatment with lasofoxifene was not higher than for placebo. 
Na osnovi podatkov iz 5 in 3 letnih kliničnih študij pogostnost raka med bolnicami, ki so prejemale lasofoksifen ni bila večja kot pri bolnicah, ki so prejemale placebo.
When determining the choice of FABLYN or other therapies, including estrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1). 
Ko se pri ženski v postmenopavzi odločamo med zdravilom FABLYN in drugimi zdravili, vključno z estrogeni, moramo upoštevati simptome menopavze, vpliv na maternično tkivo in tkivo dojk ter tveganja in koristi za srčnožilni sistem (glejte poglavje 5.1).
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. 
Pri ženskah s postmenopavzalno osteoporozo zdravilo FABLYN zmanjša tveganje tako zlomov hrbtenice (zlomov vretenc) kot nehrbteničnih zlomov (nevretenčni zlomi), ne pa zlomov kolkov.
Do not use FABLYN after the expiry date which is stated on the blister or bottle label and on the carton after “EXP:”. 
Zdravila FABLYN ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu ali na nalepki plastenke in na škatli poleg oznake “ Uporabno do:”.
Lasofoxifene was not genotoxic in any of the battery of tests applied. 
Lasofoksifen ni bil toksičen pri nobenem uporabljenem testu iz sklopa testov, ki so ga opravili.
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). 
V preskušanjih zdravljenja osteoporoze je zdravljenje z zdravilom FABLYN povzročilo skladno, statistično signifikantno zaviranje resorpcije kosti in nastajanje kosti, kar se je zrcalilo v spremembah označevalcev premene kostnine v serumu in urinu (npr. C-telopeptida in označevalcev nastajanja kosti: osteokalcina, N-terminalnega propeptida prokolagena tipa 1 in za kost specifične alkalne fosfataze).
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). 
V kliničnih študijah lasofoksifen ni spremenil presnove dekstrometorfana (substrat CYP2D6) in klorzoksazona (substrat CYP2E1) niti farmakokinetike varfarina (substrat CYP2C9), metilprednizolona (substrat CYP3A4) ali digoksina (substrat P-glikoproteina MDR1).
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. 
Vezavna afiniteta poglavitnih presnovkov lasofoksifena v krvi za estrogenski receptor alfa in estrogenski receptor beta je bila vsaj 31-krat oziroma 18-krat manjši od vezavne afinitete lasofoksifena, kar kaže, da ni verjetno, da bi ta presnovka prispevala k farmakološki aktivnosti lasofoksifena.
The apparent oral clearance (CL/F) of lasofoxifene in postmenopausal women is approximately 6.6 l/hr. 
Navidezni peroralni očistek (CL/F) lasofoksifena pri ženskah v postmenopavzi je približno 6,6 l/h.
Uncommon: Palpitations, tachycardia 
Občasni: palpitacije, tahikardija
Triangular, peach-coloured, film-coated tablets debossed with “Pfizer” on one side and “OPR 05” on the other side. 
Trikotne, filmsko obložene tablete breskove barve z vtisnjenim napisom “Pfizer” na eni strani in “OPR 05” na drugi strani.
There was no evidence of osteomalacia, marrow fibrosis, cellular toxicity, woven bone or other abnormalities affecting the quality of the bone following lasofoxifene treatment. 
Znakov osteomalacije, fibroze kostnega mozga, celične toksičnosti, prepletene (retikularne) kostnine ali drugih nenormalnosti, ki bi vplivale na kakovost kosti po zdravljenju z lasofoksifenom, niso našli.
A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1). 
Dokazali so, da zdravilo signifikantno zmanjša pogostnost vretenčnih zlomov in drugih zlomov kosti, ne pa zlomov kolka (glejte poglavje 5.1).
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. 
Izpostavljenost lasofoksifenu v plazmi je bila pri zdravih osebah približno enaka kot pri osebah z blago okvaro jeter (razred A po Child-Pughovi lestvici), pri osebah z zmerno okvaro jeter (razred B po Child-Pughovi lestvici) pa je bila v primerjavi z zdravimi osebami zmerno zvečana (38 %).
• The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs. 
o Potreba po prekinitvi zdravljenja z zdravilom FABLYN in raziskavi vzrokov za pojav nepojasnjene krvavitve iz maternice.