natgillin/translations-raw huggingface dataset:
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.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all healthcare professionals who are expected to prescribe FABLYN or order gynaecological ultrasound of patients treated with FABLYN, are provided with access to risk minimisation educational programme.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo pred prihodom zdravila na trg zagotovil ustrezen dostop do izobraževalnega programa za zmanjševanje tveganja vsem zdravstvenim delavcem, ki so pristojni za predpisovanje zdravila FABLYN ali za napotitev bolnic zdravljenih z zdravilom FABLYN na ginekološko ultrazvočno preiskavo.
The reduction in the incidence of non-vertebral fractures was also observed in postmenopausal women with severe osteoporosis (defined as a baseline lumbar spine BMD T-score ≤ -2.5 + prevalent fracture or BMD T-score ≤ -3) (p = 0.0183).
Zmanjšanje pogostnosti nevretenčnih zlomov so opazili tudi pri ženskah v postmenopavzi s hudo osteoporozo (opredeljeno kot T-vrednost BMD ledvene hrbtenice na začetku študije ≤ -2,5 + prevladujoč zlom ali T-vrednost ≤ -3) (p = 0,0183).
• Decreased pulse in feet, bruising
• oslabljen utrip v stopalih, modrice.
FURTHER INFORMATION
DRUGI PODATKI
All women in the study received calcium (1,000 mg/day) and Vitamin D (400-800 IU/day).
Vse ženske v tej študiji so jemale kalcij (1.000 mg/dan) in vitamin D (400-800 i.e./dan).
Table 1: Adverse reactions observed in placebo-controlled osteoporosis treatment clinical trials in more FABLYN-treated women than in placebo-treated women
Preglednica 1: Neželeni učinki, ki so jih opazili v kliničnih preskušanjih zdravljenja osteoporoze, kontroliranih s placebom, pri več ženskah, zdravljenih z zdravilom FABLYN, kot pri ženskah, ki so jemale placebo
Unexplained uterine bleeding.
Nepojasnjena krvavitev iz maternice.
If you take more tablets than you should, tell your doctor or pharmacist.
Če ste vzeli večji odmerek zdravila FABLYN , kot bi smeli Če ste vzeli več tablet, kot bi smeli, povejte svojemu zdravniku ali farmacevtu.
Based on the absence of clinically relevant effects of cholestyramine (anion exchange resin), fluconazole (CYP2C9 inhibitor), ketoconazole (CYP3A4/5 inhibitor) and paroxetine (CYP2D6 inhibitor) on lasofoxifene pharmacokinetics, other anion exchange resins and other inhibitors of these CYP isoforms are unlikely to produce clinically meaningful alterations in FABLYN exposure and no dose adjustments are required.
Na podlagi odsotnosti klinično pomembnih učinkov holestiramina (anionska izmenjevalna smola), flukonazola (inhibitor CYP2C9), ketokonazola (inhibitor CYP3A4/5) in paroksetina (inhibitor CYP2D6) na farmakokinetiko lasofoksifena ni verjetno, da bi druge smole za izmenjavo anionov in drugi inhibitorji izoform CYP povzročali klinično pomembne spremembe izpostavljenosti zdravilu FABLYN in zato prilagoditve odmerka niso potrebne.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije pri sesalcih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
• This medicine has been prescribed for you.
• Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
It is not known whether lasofoxifene is excreted in human milk.
Ni znano, ali se lasofoksifen izloča v materino mleko.
MARKETING AUTHORISATION NUMBER EU/1/08/500/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/500/001
FABLYN-treated and placebo-treated groups had similar incidences of endometrial hyperplasia and endometrial cancer (see section 5.1).
Skupine bolnic, zdravljene z zdravilom FABLYN, in tiste, ki so jemale placebo, so imele podobno pogostnost endometrijske hiperplazije in endometrijskega raka (glejte poglavje 5.1).
All women in the study received calcium (600-1200 mg/day) and Vitamin D (400-800 IU/day).
Vse ženske v tej študiji so jemale kalcij (6001.200 mg/dan) in vitamin D (400-800 i.e./dan).
Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: Fibroma, uterine leiomyoma Rare:
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Občasni: fibrom, maternični leiomiom
FABLYN is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Zdravilo FABLYN je indicirano za zdravljenje osteoporoze pri ženskah v postmenopavzi z zvečanim tveganjem zloma kosti.
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo odobreno {MM/LLLL}
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.
V primerjavi s placebom je zdravilo FABLYN signifikantno zižalo celotni holesterol, LDL holesterol, z LDL povezani apolipoprotein B-100 in Creaktivni protein z veliko občutljivostjo (mediane spremembe -10,4 %, -15,8 %, -11,8 % oziroma12,5 %); pri HDL holesterolu in VLDL holesterolu signifikantnih sprememb v primerjavi s placebom niso našli.
Ketoconazole - The strong CYP3A4/5 inhibitor ketoconazole increased the systemic exposure of lasofoxifene by 20% which is not considered to be clinically meaningful.
Ketokonazol - Močni inhibitor CYP3A4/5 ketokonazol je zvečal sistemsko izpostavljenost lasofoksifenu za 20 %, kar ne velja za klinično pomembno.
It must not be taken by women of child-bearing potential, pregnant women and lactating women (see section 4.6).
Ženske v rodni dobi, nosečnice in doječe matere ga ne smejo jemati (glejte poglavje 4.6).
Decreases in estrogen levels after menopause or oophorectomy lead to accelerated bone loss due to increased bone turnover, where bone resorption exceeds bone formation.
Znižanje koncentracije estrogenov po menopavzi ali ooforektomiji povzroči pospešeno izgubo kosti zaradi zvečanja premene kostnine, pri katerem je resorpcija kosti večja od njenega nastajanja.
FABLYN is used to treat osteoporosis in women after the menopause (postmenopausal osteoporosis) who are likely to break bones, especially in the spine, hips and wrists.
Zdravilo FABLYN se uporablja za zdravljenje osteoporoze pri ženskah po menopavzi (postmenopavzalna osteoporoza), pri katerih bi lahko prišlo do zlomov kosti, posebno še v hrbtenici, kolkih in zapestjih.
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.
Lasofoksifen je lahko pri nekaterih osebah povezan z benignimi učinki na endometrij: cistično spremembo endometrija, vidno z ultrazvokom, in histološko benigno cistično atrofijo (varianta atrofičnega endometrija), ki prispeva k približno 1,5-milimetrskem povečanju povprečne debeline endometrija.
FABLYN has no known influence on the ability to drive and use machines.
Ni znano, da bi zdravilo FABLYN vplivalo na sposobnost vožnje in upravljanja s stroji.
As observed with other Selective Estrogen Receptor Modulators (SERMs), slightly decreased (approximately 4%) platelet counts were observed in lasofoxifene-treated patients in PEARL.
Kot pri ostalih zdravilih iz skupine SERM (Selective Estrogen Receptor Modulators) so pri bolnicah v študiji PEARL, ki so bile zdravljene z lasofoksifenom, opazili rahlo zmanjšanje števila trombocitov (za približno 4%).
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.
V podskupini študijske populacije, kjer so proučevali endometrijsko histologijo (1.080 bolnic) s TVU po 3 letih, so poročali o histološko benignih endometrijskih polipih pri 20 od 366 (5,5 %) žensk, zdravljenih z zdravilom FABLYN, in 12 od 360 (3,3 %) žensk, ki so jemale placebo.
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.
Ugotovili so pet presnovnih poti lasofoksifena: direktna glukuronidacija; direktna sulfatacija; hidroksilacija na fenilnem tetralinskem delu molekule (s poznejšo konjugirano presnovo kateholnih vmesnih produktov z metilacijo in glukuronidacijo); oksidacija na pirolidinskem obroču; in fenilna hidroksilacija.
Lasofoxifene is a SERM whose biological actions are largely mediated through binding to estrogen receptors.
Lasofoksifen je SERM, ki biološko učinkuje večinoma prek vezave na estrogenske receptorje.
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.
V 3-letni podštudiji študije PEARL (n=760) je zdravilo FABLYN po 3 letih signifikantno zvečalo BMD (v primerjavi s placebom) v ledveni hrbtenici (3,3 %), celotnem kolku (3,0 %), stegneničnem vratu (3,3 %), velikem trohantru (3,6 %), intertrohanternem predelu (2,6 %), Wardovem trikotniku (5,9 %) in podlaktu (1,8 %).
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).
Razlog, da so postopek maternične diagnostike opravili pri večjem številu bolnic zdravljenih z zdravilom FABLYN kot pa je narekoval protokol, so bile vaginalne krvavitve (kot je narekoval protokol) in asimptomatske endometrijske ugotovitve (npr. sum na maternične polipe, zadebelitev endometrija).
FABLYN contains lactose.
Zdravilo FABLYN vsebuje laktozo.
• References to authoritative international guidelines relevant for uterine surveillance.
o Navedba verodostojnih mednarodnih smernic, ki se nanašajo na spremljanje stanja maternice, kot reference.
Vertebral fractures are the most common type of osteoporotic fracture in postmenopausal women.
Najpogostejša vrsta zlomov zaradi osteoporoze pri ženskah v postmenopavzi so vretenčni zlomi.
This decrease was observed through the first year and maintained through 5 years.
To zmanjšanje so opazili prvem letu in je vztrajalo vseh 5 let.
If you forget to take FABLYN
Če ste pozabili vzeti zdravilo FABLYN
Bone histomorphometry
Histomorfometrija kosti
So any vaginal bleeding while you take FABLYN is unexpected.
Zato je vsaka krvavitev iz nožnice med zdravljenjem z zdravilom FABLYN nepričakovana.
FABLYN also significantly increased whole body bone mineral content (BMC), compared to placebo, at 3 years.
Zdravilo FABLYN je v primerjavi s placebom po 3 letih tudi signifikantno zvečalo vsebnost kostnih mineralov v vsem telesu (BMC-Bone Mineral Content).
Lasofoxifene is extensively metabolized in humans.
Lasofoksifen se pri ljudeh v veliki meri presnavlja.
Effects on breast:
Učinki na dojke:
This decrease was observed through the first year and was maintained through 5 years.
To zmanjšanje so opazili v prvem letu in je trajalo vseh 5 let.
• Very rare: affects less than 1 user in 10,000
• Zelo redki: pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov
90 film-coated tablets
90 filmsko obloženih tablet
Pharmacokinetic data from over 2,000 postmenopausal women including patients in selected osteoporosis clinical trials contributed to a population pharmacokinetic analysis.
K populacijski farmakokinetični analizi so prispevali farmakokinetični podatki, pridobljeni pri okrog 2.000 ženskah v postmenopavzi, vključno z bolnicami v izbranih kliničnih preskušanjih osteoporoze.