natgillin/translations-raw huggingface dataset:
These side effects may occur with certain frequencies, which are defined as follows: 
Neželeni učinki se pojavijo z določeno pogostnostjo, ki je določena kot:
Your doctor may recommend that you stop treatment at least 3 weeks prior to this time. 
Mogoče vam bo zdravnik priporočil, da vsaj 3 tedne prej prekinete zdravljenje.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Do not take a double dose to make up for a forgotten tablet. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
Similar results for vaginal pH and MI were observed in the PEARL study. 
Podobne rezultate za vaginalni pH in MI so dosegli v študiji PEARL.
Most of the side effects that occurred during studies were mild. 
Večina neželenih učinkov, ki so se pojavili med študijami, je bila blagih.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR). 
V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
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. 
To je potrebno zato, ker dolgotrajno sedenje v istem položaju lahko zmanjša prekrvavitev in lahko poveča tveganje za nastanek krvnih strdkov;
Other venous thromboembolic events could also occur. 
Lahko se pojavijo tudi drugi venski trombembolični dogodki.
These changes are not considered to be clinically meaningful. 
Ti spremembi ne veljata za klinično pomembni.
Overall, the reproductive and developmental effects observed in animals are consistent with the SERM class of compounds. 
Na splošno se reprodukcijski in razvojni učinki, ki so jih ugotovili pri živalih, ujemajo s skupino spojin SERM.
-All clinical fractures 
-Vsi klinični zlomi
• if you are pregnant or breast-feeding. 
• če ste noseči ali dojite.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE 
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
• OTHER CONDITIONS 
DRUGI POGOJI
These differences are not considered to be clinically meaningful. 
Te razlike ne veljajo za klinično pomembne.
Therefore safety and efficacy have not been studied (see section 5.2). 
Zato študije varnosti in učinkovitosti niso izvedli (glejte poglavje 5.2).
** Endometrial hyperplasia events based on investigator reporting rather than histopathology findings and did not require histological confirmation. 
**Primeri endometrijske hiperplazije so temeljili na poročanju raziskovalcev, ne na histopatoloških izidih, in zanje ni bila potrebna histološka potrditev.
• if you are allergic (hypersensitive) to lasofoxifene or any of the other ingredients of FABLYN. 
• če ste alergični (preobčutljivi) na lasofoksifen ali katerokoli sestavino zdravila FABLYN;
This programme should focus on interpretation of endometrial biopsy of women treated with FABLYN. 
Ta program bo osredotočen predvsem na interpretacijo biopsije endometrija žensk, ki so se zdravile z zdravilom FABLYN.
This must be investigated by your doctor before starting treatment. 
Pregledati vas mora vaš zdravnik, še preden začnete zdravljenje;
It belongs to a group of medicines called Selective Estrogen Receptor Modulators (SERM). 
Pripada skupini zdravil, ki se imenujejo selektivni modulatorji estrogenskih receptorjev (SERM).
It must be in line with authoritative international guidelines and supported by evidence published in peer reviewed medical journals. 
Program mora biti v skladu z verodostojnimi mednarodnimi smernicami in podprt z navedbami v strokovni medicinski periodiki.
Do not take FABLYN if you are pregnant or breast-feeding as it might be excreted in mother's milk. 
Ne jemljite zdravila FABLYN, če ste noseči ali dojite, ker bi se zdravilo lahko izločalo v materino mleko.
Pharmacovigilance system 
Sistem farmakovigilance
The overall incidence of vaginal bleeding was low (≤ 2.6% in all treatment groups). 
Skupna pogostnost vaginalnih krvavitev je bila majhna (≤ 2,6 % v vseh zdravljenih skupinah).
The Manufacturer is Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Germany. 
Izdelovalec je Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Nemčija.
Lasofoxifene is highly bound to proteins in human plasma (>99%). 
Lasofoksifen se v velikem deležu veže na beljakovine v človeški plazmi (>99 %).
Abbreviations: n= number of patients; CI = Confidence Intervals a p < 0.0001; b p = 0.0004; c p = 0.0002; d p = 0.0020; e p = 0.0004 
Okrajšave: n= število bolnic; CI = intervali zaupanja ap < 0,0001; bp = 0,0004; cp = 0,0002; dp = 0,0020; e p = 0,0004
Effects on lipid metabolism and cardiovascular risk: 
Učinki na presnovo lipidov in kardiovaskularno tveganje:
In each system organ class and frequency, adverse reactions are not presented in order of decreasing seriousness but in alphabetical order. 
Pri vsakem organskem sistemu v posamezni skupini pogostnosti neželenih učinkov niso navedene po padajoči resnosti ampak po abecednem redu.
OTHER SPECIAL WARNING(S), IF NECESSARY Sealed pack. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zalepljeno pakiranje.
Bone formed during two years' administration of lasofoxifene is of normal quality. 
Kost, ki nastane med dveletno uporabo lasofoksifena, je normalne kakovosti.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being 
• v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z
In addition, women taking FABLYN should be advised to move about periodically during prolonged travel. 
Poleg tega moramo ženskam, ki jemljejo zdravilo FABLYN, svetovati, naj se med dolgotrajnimi potovanji v rednih presledkih nekoliko sprehodijo.
Name and address of the manufacturer responsible for batch release Pfizer Manufacturing Deutschland GmbH 
Ime in naslov izdelovalca, odgovornega za sproščanje serije Pfizer Manufacturing Deutschland GmbH
• Diabetes (typical symptoms are excessive thirst, frequent urination) 
• sladkorna bolezen (tipični simptomi so čezmerna žeja, pogosto odvajanje vode);
• if you have or have had breast cancer. 
• če imate ali ste kdaj prej imeli raka dojke;
Lasofoxifene has a half-life of approximately 6 days. 
Lasofoksifen ima razpolovni čas približno 6 dni.
The recommended dose is one 500 microgram tablet daily. 
Priporočeni odmerek je ena 500 mikrogramska tableta na dan.
In some asymptomatic patients, hot flushes may occur upon beginning therapy. 
Pri nekaterih bolnicah brez simptomov se lahko po začetku zdravljenja pojavijo vročinski oblivi.
Absorption: 
Absorpcija:
The MAH shall also provide access to educational programme for pathologists. 
Imetnik dovoljenja za promet z zdravilom bo zagotovil dostop do izobraževalnega programa tudi patologom.
Adult (postmenopausal women): 
Odrasle bolnice (ženske v postmenopavzi):
Although all of these tumours are believed to be the result of rodent-specific hormonal mechanisms, their relevance for humans is currently unknown. 
Ti tumorji so verjetno posledica hormonskih mehanizmov, ki so značilni za glodalce, vendar pa njihovega pomena pri človeku trenutno ne poznamo.
5-year results from large, multinational fracture trial (PEARL) 
5-letni rezultati velikega multinacionalnega preskušanja zlomov (PEARL)
Effects on vulvar and vaginal atrophy (VVA): 
Učinki na atrofijo vulve in vagine (VVA-vulvar and vaginal atrophy):
Adverse reactions are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)). 
Opisani neželeni učinki so navedeni spodaj po organskem sistemu in pogostnosti (zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100)> in redki (≥1/10.000 do <1/1.000)).
Name and address of the manufacturer of the biological active substance Not applicable 
Ime in naslov izdelovalca biološke zdravilne učinkovine Navedba smiselno ni potrebna
Effects on the endometrium: 
Učinki na endometrij:
Taking FABLYN with food and drink 
Jemanje zdravila FABLYN skupaj s hrano in pijačo
Any unexplained vaginal bleeding should be investigated as clinically indicated. 
Vsako nepojasnjeno krvavitev iz nožnice je treba ustrezno klinično raziskati.
Due to the chronic nature of the disease process, FABLYN is intended for long-term use (see section 5.1). 
Zaradi kronične narave bolezenskega procesa je zdravilo FABLYN namenjeno za dolgotrajno uporabo (glejte poglavje 5.1).
Linearity/non-linearity: 
Linearnost/nelinearnost:
Therefore, FABLYN should be used for the treatment of osteoporosis only after the treatment of breast cancer, including adjuvant therapy, has been completed. 
Zato smemo zdravilo FABLYN uporabiti za zdravljenje osteoporoze šele potem, ko je zdravljenje raka dojke, vključno z dopolnilnim zdravljenjem, končano.
The apparent volume of distribution (V/F) of lasofoxifene in postmenopausal women is approximately 1,350 l. 
Navidezni volumen porazdelitve (V/F) lasofoksifena pri ženskah v postmenopavzi je približno 1.350 l.
Table 2: Fracture incidence in postmenopausal women over 5 years 
Preglednica 2: Pogostnost zlomov pri ženskah v postmenopavzi v obdobju 5 let
• Tiredness, abnormal or excessive bleeding commonly from the nose 
• utrujenost, nenormalna ali čezmerna krvavitev, navadno iz nosu;
Treatment with FABLYN can be restarted as soon as you regain your mobility and in consultation with your doctor. 
Zdravljenje z zdravilom FABLYN se lahko začne, takoj ko se spet začnete gibati, prej pa se posvetujte s svojim zdravnikom;
Pharmacotherapeutic group: Selective Estrogen Receptor Modulator (SERM), ATC code: {not yet assigned} 
Farmakoterapevtska skupina: Selektiven modulator estrogenskih receptorjev (SERM), oznaka ATC: {not yet assigned}
• Pressure in the lower abdomen 
• pritisk v spodnjem delu trebuha;
No studies on the effects on the ability to drive and use machines have been performed. 
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
• if you are taking FABLYN, you should walk around or exercise your legs and feet at regular intervals when traveling long distances. 
• če jemljete zdravilo FABLYN, se morate med dolgimi potovanji občasno sprehoditi ali v rednih presledkih razgibati noge in stopala.
You should talk to your doctor before starting to take FABLYN: 
Pogovorite se s svojim zdravnikom, preden začnete jemati zdravilo FABLYN:
• Dry mouth, flatulence (excessive amount of air or gases in the stomach or the intestine), 
• suha usta, vetrovi (čezmerna količina zraka ali plinov v želodcu ali črevesu), bolečina v želodcu;
The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing 90 tablets. 
Tablete so na voljo v pretisnih omotih, ki vsebujejo 7, 28 ali 30 tablet, in v plastenkah, ki vsebujejo 90 tablet.
INFORMATION IN BRAILLE FABLYN 
PODATKI V BRAILLOVI PISAVI FABLYN
Excipient: Each film-coated tablet contains 71.34 mg lactose. 
Pomožna snov: Ena filmsko obložena tableta vsebuje 71,34 mg laktoze.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih vrst sladkorjev, se pred začetkom jemanja tega zdravila posvetujte z njim.
This analysis included 2,049 postmenopausal women consisting of 85.5% Caucasian, 8.6% Hispanic, 3.4% Asian, and 1.9% African American. 
V to analizo je bilo vključenih 2.049 žensk v postmenopavzi, in sicer 85,5 % belk, 8,6 % Latinoameričank, 3,4 % Azijk in 1,9 % Afroameričank.
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. 
Vpliv zdravila FABLYN na profil lipidov so ovrednotili v 3-letni podštudiji študije PEARL; podštudija je zajela 1.014 žensk v postmenopavzi.
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. 
Supresija označevalcev premene kostnine je postala očitna po 3 mesecih in je v podštudiji študije PEARL trajala celotno 36-mesečno obdobje opazovanja.
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. 
V populacijski farmakokinetični analizi ni bilo klinično pomembnih razlik v farmakokinetiki lasofoksifena med ženskami v postmenopavzi z ocenjenim očistkom kreatinina do 32 ml/min in tistimi z normalnim očistkom kreatinina.
Warfarin - Lasofoxifene had no effect on the pharmacokinetics of R- and S- warfarin. 
Varfarin - Lasofoksifen ni vplival na farmakokinetiko R- in S-varfarina.
The disposition of lasofoxifene was evaluated in 758 subjects in conventional clinical pharmacology studies. 
Odstranjevanje lasofoksifena so ovrednotili v konvencionalnih kliničnofarmakoloških študijah pri 758 osebah.
Swallow the tablet whole. 
Tableto pogoltnite celo.
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. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
There are no adequate data from the use of lasofoxifene in pregnant women. 
O uporabi lasofoksifena pri nosečnicah ni na voljo zadostnih podatkov.
* Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings. 
* Hipertrofija endometrija je izraz v slovarju MedDRA, ki predstavlja ultrazvočno ugotovitev spremenjene debeline endometrija.
Like all medicines, FABLYN can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo FABLYN neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Lasofoxifene was studied, as a single 0.25 mg dose, in healthy subjects and subjects with mild or moderate hepatic impairment. 
Lasofoksifen so v obliki enkratnega 0,25 miligramskega odmerka proučevali pri zdravih osebah in osebah z blagimi ali zmernimi okvarami jeter.
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. 
Oksidacija z več citokromi P450, med drugim CYPs 2D6 in 3A4/5, in konjugacija lasofoksifena sta dva primarna mehanizma odstranjevanja lasofoksifena iz sistemskega krvnega obtoka.
Any unexplained breast abnormality occurring during FABLYN therapy should be investigated. 
Vsako nepojasnjeno nenormalnost dojk, ki se pojavi med zdravljenjem z zdravilom FABLYN, moramo raziskati.
To assess bone quality, bone biopsies were obtained from 71 postmenopausal women enrolled in BMD trials after 2 years of treatment. 
Za ocenjevanje kakovosti kosti so odvzeli kostne biopsije 71 ženskam v postmenopavzi, ki so bile vključene v preskušanja BMD, po 2 letih zdravljenja.
FABLYN does not eliminate the risk of breast cancer (see section 5.1). 
Zdravilo FABLYN ne odpravi tveganja raka dojke (glejte poglavje 5.1).
This medicine does not require any special storage conditions. 
Za shranjevanje zdravila niso potrebna posebna navodila.
• Painful urination, blood in urine 
• bolečine pri odvajanju vode, kri v urinu
• Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs. 
o Na osnovi kliničnih preskušanj so morfološke spremembe, ki jih povzroči zdravilo FABLYN, benigne in ne zahtevajo nadaljnjih preiskav, razen pri pojavu krvavitev iz nožnice.
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. 
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 1.4 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
Blister packs of 7, 28 or 30 tablets and bottles of 90 tablets. 
Pretisni omoti s 7, 28 ali 30 tabletami in plastenke z 90 tabletami.
• If you have any further questions, ask your doctor or pharmacist. 
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
• 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). 
• če ste nekaj časa nepokretni, na primer, če morate oditi v bolnišnico ali morate ležati, med okrevanjem po operaciji ali bolezni, ker se v takem primeru lahko zveča nevarnost nastajanja krvnih strdkov (globoka venska tromboza, pljučna embolija ali tromboza mrežnične vene).
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). 
Učinkovitost zdravila FABLYN za zdravljenje VVA so raziskali v dveh 12-tedenskih študijah faze 3 pri ženskah v postmenopavzi z zmernimi ali težkimi znaki in simptomi VVA, ne glede na status osteoporoze (zajeli sta 889 bolnic).
The duration of treatment in postmenopausal women was 12 months, 124 were exposed to FABLYN and 125 were exposed to placebo. 
Zdravljenje žensk v postmenopavzi je trajalo 12 mesecev, 124 jih je bilo izpostavljenih zdravilu FABLYN, 125 pa placebu.
Distribution: 
Porazdelitev:
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. 
Pri nekaterih ženskah te spremembe sčasoma povzročijo zmanjšanje kostne mase, osteoporozo in zvečano nevarnost zlomov, posebno hrbtenice, kolka in zapestja.
• if you have severe liver disease. 
• če imate hudo bolezen ledvic.
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. 
Opravili so analizo oseb, ki so jih napotili k njihovemu zdravniku za oceno možnosti zdravljenja s kakšnim drugim zdravilom za osteoporozo, če so opazili kaj od naslednjega: a) ≥7 % izgubo BMD v ledveni hrbtenici (LS) ali ≥10 % izgubo BMD v stegneničnem vratu v 12. mesecu; b) ≥11 % izgubo BMD v LS ali ≥14 % izgubo BMD v stegneničnem vratu v 24. mesecu; c) ≥2 rentgenskemu vretenčnemu zlomu, nastalim med študijo do 24. meseca.
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. 
Po 5 letih je bila v celotni populaciji študije (N=8.556) pogostnost pomembnih koronarnih dogodkov, vključno s koronarno smrtjo, miokardnim infarktom, ki se ni končal z bolničino smrtjo, novo ishemično boleznijo srca, hospitalizacijo zaradi nestabilne angine in postopki revaskularizacije, signifikantno manjše.
It results in increased mean endometrial thickness. 
Posledica je povečana povprečna debelina endometrija.
These referrals were significantly less frequent in the FABLYN group (0.9%) than in the placebo group (3.3%). 
Te napotitve so bile signifikantno redkejše v skupini z zdravilom FABLYN (0,9 %) kot v skupini s placebom (3,3 %).
To assess the effect of FABLYN on diagnostic uterine procedures (i.e., hysteroscopy, saline infused sonohysterogram, endometrial biopsy, polypectomy or dilation and curettage), an analysis was conducted on women without planned TVU surveillance (4,055 patients). 
Da bi ocenili vpliv zdravila FABLYN na postopke maternične diagnostike (npr. histerektomija, sonohisterogram z vbrizganjem fiziološke raztopine, endometrijska biopsija, polipektomija ali dilatacija in kiretaža), so analizirali ženske brez načrtovanega nadzora s TVU (4.055 bolnic).
It also reduced markers of bone turnover. 
Zmanjšali so se označevalci premene kostnine.
This binding results in the activation of some estrogenic pathways and a blockade of others. 
Ta vezava nekatere estrogenske presnovne poti aktivira, druge pa blokira.
FABLYN Placebo Relative risk reduction (95% CI) vs. placebo 
FABLYN Placebo Relativno zmanjšanje tveganja (95% CI) v primerjavi s placebom
Lasofoxifene is slowly absorbed from the gastrointestinal tract with maximal plasma concentrations attained on average by approximately 6 hours after dosing. 
Lasofoksifen se počasi absorbira iz prebavil, najvišje plazemske koncentracije so povprečno dosežene približno 6 ur po odmerku.
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. 
Rezultati faze 1 študije na Japonkah in belkah so se skladali s populacijsko farmakokinetično analizo in niso kazali vidnih razlik farmakokinetike lasofoksifena pri teh dveh populacijah.
The tablet may be taken any time of day without regard to food and beverage intake. 
Tableto lahko bolnica vzame ob kateremkoli dnevnem času ne glede na uživanje hrane in pijače.
No data are available on its concomitant use with agents used in the treatment of early or advanced breast cancer. 
Podatkov o sočasni uporabi lasofoksifena z zdravili, ki se uporabljajo pri zdravljenju zgodnjega ali napredovalega raka dojke, ni na voljo.
NAME OF THE MARKETING AUTHORISATION HOLDER Eberth 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Eberth
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. 
Pri ženskah, vključenih v to študijo, je bila mediana starost 67 let (razpon 59 do 80), mediani čas od menopavze pa 20 let.
Since FABLYN is indicated for use only in postmenopausal women, no assessment of the effect of gender on lasofoxifene pharmacokinetics has been made. 
Ker je uporaba zdravila FABLYN indicirana samo pri ženskah v postmenopavzi, vpliva spola na farmakokinetiko lasofoksifena niso proučevali.
Within this study, 12.9% of FABLYN-treated women and 12.3% of placebo-treated women discontinued therapy due to adverse events. 
Med to študijo je 12,9 % žensk, zdravljenih z zdravilom FABLYN, in 12,3 % žensk, ki so jemale placebo, prekinilo zdravljenje zaradi neželenih učinkov.
Most of the adverse reactions occurring during the studies were mild and generally did not require discontinuation of therapy. 
Večina neželenih učinkov, ki so se pojavili v teh dveh študijah, je bila blaga in zaradi njih na splošno ni bilo treba prekinjati zdravljenja.