natgillin/translations-raw huggingface dataset:
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.
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).