natgillin/translations-raw huggingface dataset:
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.
In the same study at 5 years, there was no increase in the risk of stroke including hemorrhagic, ischemic, embolic stroke, stroke type unspecified and transient ischemic attacks in FABLYN-treated patients. 
V isti študiji pri bolnicah, zdravljenih z zdravilom FABLYN, po 5 letih ni poraslo tveganje za možgansko kap, vključno s hemoragično, ishemično, embolično kapjo, nedoločeno vrsto možganske kapi in tranzitornimi ishemičnimi atakami.
Placebo-treated women had a 0.7 mm mean decrease from baseline in endometrial thickness over 3 years, whereas the FABLYN-treated women had a 1.4 mm mean increase. 
Pri ženskah, ki so prejemale placebo, se je v obdobju 3 let debelina endometrija zmanjšala povprečno za 0,7 mm od izhodiščne debeline, pri ženskah, zdravljenih z zdravilom FABLYN, pa se je za povprečno 1,4 mm zvečala.
Endocrine disorders 
Bolezni endokrinega sistema
In clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding, in accordance with guidelines for postmenopausal women (see section 4.4). 
V klinični praksi ti benigni izvidi, v skladu s smernicami za ženske v postmenopavzi, ne upravičujejo nadaljnjih diagnostičnih postopkov pri ženskah, ki nimajo krvavitev iz nožnice (glejte poglavje 4.4).
The effects of FABLYN on bone are manifested as reductions in the serum and urine levels of bone turnover markers, increases in bone mineral density (BMD), and decreases in incidence of fractures. 
Delovanje zdravila FABLYN na kost se kaže kot znižanje koncentracije označevalcev premene kostnine v serumu in urinu, zvečanje mineralne gostote kosti (BMD-Bone Mineral Density) in zmanjšanje pogostnosti zlomov
Muscle spasms occurred in about one in 9 patients . 
Mišični spazmi so se pojavili približno pri eni od 9 bolnic, ki so jemale zdravilo FABLYN.
More FABLYN-treated patients (7.0%) had a diagnostic procedure compared to placebo-treated patients (2.7%). 
Tak diagnostičen postopek je imelo več bolnic, zdravljenih z zdravilom FABLYN (7,0 %), kot bolnic, ki so jemale placebo (2,7 %).
Three metabolites of lasofoxifene were detected in plasma: the direct glucuronide conjugate, the glucuronide of a hydroxylated metabolite, and the methylated catechol. 
V plazmi so odkrili tri presnovke lasofoksifena: direktni glukuronidni konjugat, glukuronid hidroksiliranega presnovka in metilirani katehol.
Lasofoxifene clearance may be increased in patients chronically treated with inducers of CYP3A4 and UGTs (eg, phenytoin, carbamazepine, barbiturates and St John's Wort) resulting in reduced steadystate concentrations and may result in reduced efficacy. 
Očistek lasofoksifena se lahko poveča pri bolnicah, kronično zdravljenih z induktorji CY3A4 in UGT encimov (npr. fenitoin, karbamazepin, barbiturati, šentjanževka), kar povzroči nižjo koncentracijo v stanju dinamičnega ravnovesja in posledično manjšo učinkovitost zdravila.
In clinical trials, FABLYN-treated women had an increased risk of venous thromboembolic events (deep vein thrombosis and pulmonary embolism) compared to placebo. 
V kliničnih preskušanjih je bila pri ženskah, zdravljenih z zdravilom FABLYN, zvečana nevarnost venskih trombemboličnih dogodkov (globoka venska tromboza in pljučna embolija), v primerjavi s tistimi, ki so jemale placebo.
• The other ingredients are lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica, colloidal anhydrous; magnesium stearate; sunset yellow FCF aluminium lake (E110); hypromellose; lactose monohydrate; titanium dioxide (E171) and triacetin. 
• Pomožne snovi so brezvodna laktoza, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvodni koloidni silicijev dioksid; magnezijev stearat, oranžno FCF (E110), hipromeloza, laktoza monohidrat, titanov dioksid (E171) in triacetin.
In a population pharmacokinetic analysis, no discernible difference in lasofoxifene pharmacokinetics was detected in different racial groups. 
Pri populacijski farmakokinetični analizi niso odkrili vidne razlike farmakokinetike lasofoksifena pri različnih rasah.
The pharmacokinetics of lasofoxifene have not been evaluated in a paediatric population. 
Farmakokinetike lasofoksifena v otroški populaciji niso preučili.
• Burning sensation, dizziness, numbness, memory impairment, impaired or partial loss of movement of a limb, headache, restless legs syndrome (an irresistible urge to move legs to stop an uncomfortable or odd sensations) 
• pekoč občutek, omotica, odrevenelost, spominske motnje, zmanjšana ali delno izgubljena gibljivost katerega od udov, glavobol, sindrom nemirnih nog (nepremagljiva želja, da bi migali z nogami in se s tem rešili nelagodnih ali čudnih občutkov);
Steady-state pharmacokinetics of lasofoxifene are consistent with expectations from its single-dose pharmacokinetics. 
Farmakokinetika lasofoksifena je v stanju dinamičnega ravnovesja skladna s pričakovanji na podlagi njegove farmakokinetike enkratnega odmerka.
Your doctor may also advise you to take Calcium and Vitamin D supplements while you are treated with FABLYN if your daily intakes are not considered sufficient. 
Če bo zdravnik mnenja, da zaužijete dnevno premalo kalcija in vitamina D, vam bo mogoče svetoval, da med zdravljenjem z zdravilom FABLYN jemljite ustrezna prehranska dopolnila.
Patients with this medical history should have serum triglycerides monitored when taking lasofoxifene. 
Pri bolnicah s takšno anamnezo je treba med zdravljenjem z lasofoksifenom nadzorovati nivo serumskih trigliceridov.
In two-year carcinogenicity studies conducted in rats (≥1 mg/kg/day; 7 times systemic exposure following a human dose of 0.5 mg/day based on plasma AUC) an increased incidence of renal tubular adenoma and carcinoma in males and granulosa cell tumours of the ovary in females was noted. 
V dveletnih študijah kancerogenosti, ki so jih opravili pri podganah (≥1 mg/kg/dan; 7-krat večja sistemska izpostavljenost kot po odmerku 0,5 mg/dan pri človeku na podlagi plazemske AUC) so opazili večjo pogostnost tubularnega adenoma in karcinoma ledvic pri samcih in granulozocelularnih tumorjev pri samicah.
If you stop taking FABLYN 
Če ste prenehali jemati zdravilo FABLYN
New radiographic vertebral fracture in patients without any prevalent fracture at baseline Percentage of patients with new fracture n=1,970 
Novi rentgenski vretenčni zlomi pri bolnicah brez prevladujočega zloma v izhodišču Odstotni delež bolnic z novim zlomom n=1.970
Take special care with FABLYN 
Bodite posebno pozorni pri uporabi zdravila FABLYN
In all women with a uterus at baseline, histologically benign endometrial polyps were reported in 34 of 2,302 (1.5%) FABLYN-treated women versus 18 of 2,309 (0.8%) placebo-treated women. 
Od vseh žensk, ki so na začetku študije imele maternico, so o histološko benignih endometrijskih polipih poročali pri 34 od 2.302 (1.5%) žensk, zdravljenih z zdravilom FABLYN, v primerjavi z 18 od 2.309 (0,8 %) žensk, ki so jemale placebo.
There was no difference between FABLYN- and placebo-treated women in the incidences of endometrial carcinoma and endometrial hyperplasia. 
Med ženskami, zdravljenimi z zdravilom FABLYN, in tistimi, ki so jemale placebo, ni bilo razlik glede pogostnosti karcinoma endometrija in endometrijske hiperplazije.
Hot flush occurred in about one in 11 patients and was most commonly reported during the first 6 months of treatment. 
11 bolnic, ki so jemale zdravilo FABLYN, in sicer najpogosteje med prvimi 6 meseci zdravljenja.
Do not take FABLYN 
Ne uporabljajte zdravila FABLYN
• Infection in the ear, eye, respiratory tract or skin, diarrhea, blood in stools 
• okužbe ušes, oči, dihal ali kože, driska, kri v blatu;
Immune system disorders 
Bolezni imunskega sistema
Mean international normalized ratio (INR) AUC and maximum value of INR after single-dose warfarin administration with lasofoxifene were approximately 8% and 16% lower, respectively, than after warfarin alone. 
Po enkratnem odmerku varfarina z lasofoksifenom je bila srednja vrednost mednarodnega normaliziranega kvocienta (INR) površine pod krivuljo (AUC) manjša za približno 8 %, največja vrednost INR po enkratnem odmerku varfarina z lasofoksifenom pa je bila približno 16 % manjša kot pri samem varfarinu.
Renal insufficiency: 
Insuficienca ledvic:
FABLYN film-coated tablets are supplied in PVC blisters with aluminum foil backing or HDPE bottles with polyethylene/aluminum foil lined polypropylene child-resistant closures. 
Filmsko obložene tablete FABLYN so na voljo v polivinilkloridnih (PVC) pretisnih omotih z aluminijasto prekrivno folijo ali v plastenkah iz polietilena velike gostote (HDPE) s polipropilenskimi za otroke varnimi zaporkami, prevlečenimi s folijo iz polietilena in aluminija.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
As a consequence of these benign effects, more FABLYN-treated patients had a diagnostic uterine procedure compared to placebo-treated patients in the PEARL trial (see section 5.1). 
Zaradi teh benignih učinkov je imelo diagnostične preiskave maternice več bolnic, zdravljenih z zdravilom FABLYN, v primerjavi z bolnicami, ki so v študiji PEARL jemale placebo (glejte poglavje 5.1).
Table 1 lists adverse reactions occurring in the two osteoporosis treatment clinical trials that occurred at an incidence greater than placebo. 
V preglednici 1 so navedeni neželeni učinki, ki so se pogosteje kot pri placebu pojavili v dveh kliničnih preskušanjih zdravljenja osteoporoze.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept.
Safety and efficacy of FABLYN have not been evaluated in patients with severe renal insufficiency; therefore, FABLYN should be used with caution in these patients (see section 4.2 and section 5.2). 
Varnosti in učinkovitosti zdravila FABLYN niso ovrednotili pri bolnicah s hudo insuficienco ledvic; zato je treba pri teh bolnicah zdravilo FABLYN uporabljati previdno (glejte poglavje 4.2 in 5.2).
All clinical fractures Percentage of patients with clinical fracture n=2,852 
Vsi klinični zlomi Odstotni delež bolnic s kliničnim zlomom n=2.852
HOW TO TAKE FABLYN 
KAKO JEMATI ZDRAVILO FABLYN
No dose adjustment is necessary in elderly female patients (see section 5.2). 
Pri starejših bolnicah prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
These included, in some subjects, a small excess in the incidence of vaginal bleeding as well as endometrial cystic change viewed on ultrasound and histological benign cystic atrophy (a variant of atrophic endometrium). 
Pri nekaterih osebah so ti vključevali tudi nekoliko zvečano pogostnost krvavitve iz nožnice, kot tudi cistično spremembo endometrija, vidno z ultrazvokom, in histološko benigno cistično atrofijo (različica atrofičnega endometrija).
Significantly fewer women treated with FABLYN experienced moderate or severe vertebral fractures (as determined by the Genant scale) compared to women treated with placebo (5.2% placebo-treated women versus 3.3% FABLYN-treated women; p = 0.0006). 
Zmerni ali težki vretenčni zlomi (klasificirane po Genantovi lestvici) je dobilo signifikantno manj žensk od tistih, ki so jemale placebo (5,2 % žensk s placebom in 3,3 % žensk, zdravljenih z zdravilom FABLYN; p = 0,0006).
There were 0.48 events/100 patient years in the placebo group and 0.36 events/100 patient years among FABLYN-treated patients (HR = 0.75; 95% CI 0.51, 1.10, p = 0.140). 
V skupini s placebom je bilo 0,48 dogodka/100 bolnikov-let in 0,36 dogodka/100 bolnikov-let med bolnicami, zdravljenimi z zdravilom FABLYN (HR = 0,75; 95 % CI 0,51, 1,10 p = 0,140).
FABLYN may be administered any time of day without regard to food or beverage intake. 
Zdravilo FABLYN se lahko jemlje ob poljubnem dnevnem času ne glede na uživanje hrane ali pijače.
The programme materials shall be provided via the following means: 
Izobraževalni programi bodo dostopni:
Common adverse reactions considered to be related to FABLYN therapy were muscle spasms, hot flush and vaginal discharge. 
Pogosti neželeni učinki, za katere menijo, da so bili povezani z zdravljenjem z zdravilom FABLYN, so bili mišični spazmi, vročinski oblivi in izcedek iz nožnice.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 
• Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.