natgillin/translations-raw huggingface dataset:
There are no data from the use of bazedoxifene in pregnant women.
Podatkov o uporabi bazedoksifena pri nosečnicah ni na voljo.
a of subjects with ≥1 new vertebral fracture Kaplan-Meier rate estimates p-value=0.015
a oseb z ≥ 1 novim zlomom vretenc Ocene pogostnosti po Kaplan-Meierju vrednost p = 0,015
The pharmacokinetics of a 20 mg single-dose of bazedoxifene were evaluated in a study in 26 healthy postmenopausal women.
Farmakokinetiko 20 mg enkratnega odmerka bazedoksifena so ovrednotili v študiji pri 26 zdravih ženskah v postmenopavzi.
What CONBRIZA is and what it is used for What you need to know before you take CONBRIZA How to take CONBRIZA
Kaj je zdravilo CONBRIZA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo CONBRIZA Kako jemati zdravilo CONBRIZA Možni neželeni učinki
if you have or have had a blood clot (for example, in the blood vessels in your legs, lungs, or eyes).
če imate ali ste kdaj imeli krvni strdek (na primer v krvnih žilah nog, pljuč ali oči).
In rats, treatment with bazedoxifene for approximately one year partially prevented the effects of ovariectomy on numerous skeletal parameters (bone mineral content, bone mineral density, and architecture).
Pri podganah je približno enoletno dajanje bazedoksifena delno preprečilo učinke ovariektomije na številne parametre skeleta (vsebnost mineralov v kosteh, mineralna kostna gostota in arhitektura kosti).
The treatment effect was similar among those with and without prevalent vertebral fractures (Table 1).
Učinek zdravljenja je bil pri bolnicah s prisotnimi zlomi vretenc in pri tistih brez njih podoben (preglednica 1).
The efficacy of bazedoxifene was established in two multicentre, double-blind, randomised, placeboand active-control, Phase 3 trials: 3-year osteoporosis treatment trial and a 2-year osteoporosis prevention trial.
Učinkovitost bazedoksifena so dokazali v dveh multicentričnih, dvojno slepih, randomiziranih, s placebom in drugo zdravilno učinkovino nadzorovanih preskušanjih 3. faze: 3-letno preskušanje zdravljenja osteoporoze in 2-letno preskušanje preprečevanja osteoporoze.
if you are immobile (unable to move) for some time, such as being wheel-chair bound, sitting for a prolonged period of timeor having to stay in bed while recovering from an operation or illness.
če ste daljši čas nepokretni (se ne morete premikati), na primer vezani na invalidski voziček, dolgo časa sedite ali morate med okrevanjem po operaciji ali bolezni ostati v postelji.
The majority of adverse reactions occurring during the clinical trials were mild to moderate in severity and did not lead to discontinuation of therapy.
Neželeni učinki, ki so se pojavili med kliničnimi preskušanji, so bili po izraženosti večinoma blagi do zmerni in niso zahtevali prekinitve zdravljenja.
The most frequent drug-related adverse reactions in double-blind, randomised studies were hot flushes and muscle spasms (includes leg cramps).
Najpogostejši neželeni učinki, povezani z zdravilom, v dvojno slepih randomiziranih študijah so bili vročinski oblivi in mišični krči (vključno s krči v nogah).
This medicine should be taken with an adequate amount of calcium and vitamin D. Consult your doctor to see if your dietary calcium and vitamin D intake is adequate and whether you need calcium and vitamin D supplementation.
To zdravilo jemljite z ustrezno količino kalcija in vitamina D. Posvetujte se z zdravnikom, ali uživate hrano z dovolj kalcija in vitamina D in ali potrebujete dodatke kalcija in vitamina D. Če jemljete dodatke kalcija in/ali vitamina D, jihlahko jemljete sočasno s tem zdravilom.
The mean pharmacokinetic parameters of bazedoxifene after multiple doses in healthy postmenopausal ambulatory women who were naturally postmenopausal or who had undergone bilateral oophorectomy are summarized in Table 2.
Povprečni farmakokinetični parametri bazedoksifena po večkratnih odmerkih pri zdravih pokretnih ženskah v postmenopavzi, ki so imele bodisi naravno menopavzo bodisi bilateralno ooforektomijo, so povzeti v preglednici 2.
There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin, azithromycin, or an antacid containing aluminium and magnesium hydroxide.
Med bazedoksifenom in naslednjimi zdravili ni bilo pomembnih farmakokinetičnih interakcij: ibuprofen, atorvastatin, azitromicin in antacid, ki je vseboval aluminijev in magnezijev hidroksid.
The mean LS and FN T-scores at baseline were -2.4 and -1.7, respectively.
Povprečni oceni T LS in FN v izhodišču sta bili -2,4 oziroma -1,7.
Elderly patients
Starejše bolnice
Elderly patients No dose adjustment is necessary based on age (see section 5.2).
Starejše bolnice Prilagajanje odmerka na podlagi starosti ni potrebno (glejte poglavje 5.2).
Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Imetnik dovoljenja za promet z zdravilom: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija.
Importantly, in both species, the administration of bazedoxifene had no deleterious effects on bone quality.
Pomembno je, da pri nobeni od teh dveh živalskih vrst dajanje bazedoksifena ni škodljivo vplivalo na kakovost kosti.
Bazedoxifene is eliminated with a half-life of approximately 30 hours.
Bazedoksifen se odstranjuje iz telesa z razpolovnim časom približno 30 ur.
In a post-hoc analysis, the 10-year fracture probability as an index of baseline fracture risk was determined.
V naknadni (post-hoc) analizi so ugotovili 10-letno verjetnost zloma kot indeks tveganja izhodiščnega zloma.
After 3 years the relative risk was 1.63 and after a 5 year study period the relative risk was 1.50.
Po 3 letih je relativno tveganje znašalo 1,63, po petih letih izvajanja študije pa je relativno tveganje znašalo 1,50.
In a post-hoc analysis, the relative risk of non-vertebral fractures in bazedoxifene-treated subjects decreased with increased fracture probability.
V naknadni analizi se je relativno tveganje za nevretenčne zlome pri osebah, zdravljenih z bazedoksifenom, zmanjševalo z rastočo verjetnostjo zlomov.
It is used for the treatment of osteoporosis in women after they have reached menopause, when they are at an increased risk of fractures.
Uporablja se za zdravljenje osteoporoze pri ženskah po doseženi menopavzi, ko jih bolj ogrožajo zlomi kosti.
After 7 year study period the relative risk was 1.51 (see section 5.1).
Po 7 letih izvajanja študije je relativno tveganje znašalo 1,51 (glejte poglavje 5.1).
if you have any unexplained vaginal bleeding.
če imate nepojasnjeno krvavitev iz nožnice.
Bazedoxifene undergoes metabolism by uridine diphosphate glucuronosyltransferase (UGT) enzymes in the intestinal tract and liver (see section 5.2).
Bazedoksifen se presnavlja preko encimov uridin difosfat glukuroniltransferaz (UGT) v črevesju in jetrih (glejte poglavje 5.2).
Similar reductions in the rate of bone turnover have been observed in the osteoporosis prevention study.
Podobno zmanjšanje hitrosti premene kostnine so opazili v študiji preprečevanja osteoporoze.
CONBRIZA contains the active substance bazedoxifene, and is a medicine that belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs).
Zdravilo CONBRIZA vsebuje zdravilno učinkovino bazedoksifen in je zdravilo, ki spada v skupino nehormonskih zdravil z imenom selektivni modulatorji estrogenskih receptorjev (SERM).
Studies in rats have shown adverse effects on fertility (see section 5.3).
Študije na podganah so pokazale škodljive vplive na plodnost (glejte poglavje 5.3).
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 je k redni prehrani treba dodajati.
Impaired renal function showed little or no influence on bazedoxifene pharmacokinetics, and no dosing adjustment is required.
Zmanjšano delovanje ledvic je malo ali nič vplivalo na farmakokinetiko bazedoksifena, prilagajanje odmerjanja torej ni potrebno.
If you forget to take CONBRIZA
Če ste pozabili vzeti zdravilo CONBRIZA
CONBRIZA 20 mg film-coated tablets
CONBRIZA 20 mg filmsko obložene tablete
Osteoporosis treatment trial
Preskušanje zdravljenja osteoporoze
The risk factors associated with VTE cases in clinical trials included: advanced age, obesity, immobilisation, surgery, major trauma and malignancy.
Dejavniki tveganja, povezani s primeri VTE v kliničnih preskušanjih bazedoksifena, so obsegali: višjo starost, debelost, imobilizacijo, operacijo, večje poškodbe in raka.
Based on in vitro bazedoxifene plasma protein binding characteristics, drug interactions with warfarin, digoxin and diazepam are unlikely.
Na podlagi in vitro značilnosti vezave bazedoksifena na plazemske beljakovine je medsebojno delovanje z varfarinom, digoksinom in diazepamom malo verjetno.
An additional study evaluating the effects of a standardized medium-fat meal on the pharmacokinetics of bazedoxifene at steady-state showed a 42% and 35% increase in Cmax and AUC, respectively, when 20 mg bazedoxifene was administered with food.
Dodatna študija, v kateri so ocenjevali učinke standardiziranega srednje mastnega obroka na farmakokinetiko bazedoksifena v stanju dinamičnega ravnovesja, je pokazala 42 % porast Cmax in 35 % porast AUC, če so 20 mg bazedoksifena dajali s hrano.
Do not take CONBRIZA
Ne jemljite zdravila CONBRIZA
When single doses of 20 mg bazedoxifene were administered with a high-fat meal, Cmax and AUC increased by 28% and 22%, respectively.
Ko so dajali enkratne 20 mg odmerke bazedoksifena z obrokom z visoko vsebnostjo maščob, je Cmax porasla za 28 % in AUC za 22 %.
Race No pharmacokinetic differences based on ethnic group were observed.
Rasa Opazili niso nikakršnih farmakokinetičnih razlik med pripadnicami različnih etničnih skupin.
This medicine may cause harm to your unborn child if taken during pregnancy.
Če bi to zdravilo jemali v nosečnosti, bi lahko škodovalo vašemu nerojenemu otroku.
Osteoporosis prevention trial
Preskušanje preprečevanja osteoporoze
PVC/Aclar blister packs of 7, 28, 30, 84, and 90 film-coated tablets.
Pretisni omoti iz PVC/Aclar, ki vsebujejo po 7, 28, 30, 84 ali 90 filmsko obloženih tablet.
It must not be taken by women who are pregnant or who could still have a baby.
Nosečnice ali ženske, ki bi še vedno lahko zanosile, ga ne smejo jemati.
If you have other events affecting the eye and/or vision (seeing sparks or flashes of light, narrowing of visual field, and swelling of eye or eyelid)
če imate druge neželene učinke, ki vplivajo na oko in/ali vid (videnje isker ali bliskov svetlobe, zoženje vidnega polja in otekanje očesa ali očesne veke)
After 3 years the relative risk was 1.63 and after a 5 year study period the relative risk was 1.50; after 7 years the relative risk was 1.51 (see sections 4.8 and 5.1).
Po treh letih je relativno tveganje znašalo 1,63, po petih letih izvajanja študije pa je relativno tveganje znašalo 1,50; po 7 letih je relativno tveganje znašalo 1,51 (glejte poglavji 4.8 in 5.1).
Therecommendeddose is one tablet by mouth daily.Taking more than one tablet daily is not more effective and may carry additional risks.
Če vzamete več kot eno tableto na dan učinkovitost ne bo večja, lahko pa je to povezano z dodatnimi tveganji.
When determining the choice of CONBRIZA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Pri odločanju za zdravljenje z zdravilom CONBRIZA ali drugimi zdravili, vključno z estrogeni, je treba upoštevati simptome menopavze, delovanje na tkiva maternice in dojk in kardiovaskularna tveganja in koristi (glejte poglavje 5.1) pri posamezni ženski v postmenopavzi posebej.
Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Ena filmsko obložena tableta vsebuje bazedoksifenijev acetat v količini, ki ustreza 20 mg bazedoksifena.
In a 30-day study, bazedoxifene increased hormone-binding globulin concentrations, including corticosteroid-binding globulin (CBG), sex hormone-binding globulin (SHBG) and thyroxine-binding globulin (TBG).
V 30-dnevni študiji je bazedoksifen zvišal koncentracije globulinov, ki vežejo hormone, med drugim globulina, ki veže kortikosteroide (CBG), globulina, ki veže spolne hormone (SHBG), in globulina, ki veže tiroksin (TBG).
Bazedoxifene must not be taken by women of child-bearing potential (see sections 4.6 and 5.3).
Ženske v rodni dobi bazedoksifena ne smejo jemati (glejte poglavji 4.6 in 5.3).
The other ingredients are lactose monohydrate (see section 2 “CONBRIZA contains lactose”), microcrystalline cellulose, pre-gelatinised starch (maize), sodium starch glycolate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171) and macrogol 400.
- Druge sestavine zdravila so laktoza monohidrat (glejte poglavje 2 ''Zdravilo CONBRIZA vsebuje laktozo''), mikrokristalna celuloza, predgelirani škrob (koruzni), natrijev karboksimetilškrob, natrijev lavrilsulfat, koloidni brezvodni silicijev dioksid, magnezijev stearat, askorbinska kislina, hipromeloza, titanov dioksid (E171) in makrogol 400.
Cerebrovascular effects
Možganskožilni učinki
It is contraindicated in women of child-bearing potential (see section 4.3).
Kontraindicirano je pri ženskah v rodni dobi (glejte poglavje 4.3).
The effects of bazedoxifene treatment on bone, uterus, and mammary gland were assessed in ovariectomized rats (0.15 to 1.5 mg/kg/day) and non-human primates [Cynomolgus macaques] (0.2 to 25.0 mg/kg/day).
Učinki dajanja bazedoksifena na kosti, maternico in mlečne žleze so ocenjevali pri ovariektomiranih podganah (odmerki 0,15 do 1,5 mg/kg/dan) in nehumanih primatih [Cynomolgus macaques] (0,2 do 25,0 mg/kg/dan).
Use of CONBRIZA is not recommended in women at an increased risk for venous thromboembolic events.
Uporaba zdravila CONBRIZA ni priporočljiva pri ženskah z zvečanim tveganjem venskih trombemboličnih dogodkov.
Safety and efficacy have not been evaluated further in patients with hepatic insufficiency.
Pri bolnicah z insuficienco jeter varnosti in učinkovitosti niso natančneje ovrednotili.
The partial preservation of bone mass was achieved by reductions in the ovariectomy-induced increases in bone turnover, evaluated by biochemical markers of bone turnover and histomorphometric indices measured in cancellous and cortical bone.
Delna ohranitev kostne mase je bila dosežena z zmanjšanjem zvečanja premene kostnine, povzročenega z ovariektomijo, vrednotenega z biokemijskimi označevalci premene kostnine in histomorfometrijskimi indeksi, izmerjenimi v retikularni in kortikalni kosti.
Bazedoxifene was not genotoxic or mutagenic in a battery of tests, including in vitro bacterial reverse mutation assay, in vitro mammalian cell forward mutation assay at the thymidine kinase (TK±) locus in L5178Y mouse lymphoma cells, in vitro chromosome aberration assay in Chinese hamster ovary (CHO) cells, and in vivo mouse micronucleus assay.
Bazedoksifen ni bil genotoksičen ali mutagen v seriji testov, med drugim pri in vitro bakterijskem testu reverznih mutacij, in vitro testu naprednih mutacij v sesalskih celicah na lokusu timidinske kinaze (TK±) v celicah mišjega limfoma L5178Y, in vitro testu kromosomskih aberacij v ovarijskih celicah kitajskega hrčka (CHO) in in vivo mikronukleusnem testu pri miših.
In clinical trials, the highest rate of VTE was observed during the first year of treatment, with a relative risk of 2.69 compared to placebo.
V kliničnih preskušanjih so največji delež VTE opažali v prvem letu zdravljenja, pri čemer je relativno tveganje v primerjavi s placebom znašalo 2,69.
This study included mostly Caucasian (87.3%) subjects who were either osteoporotic without baseline vertebral fracture (BMD T-score at lumbar spine [LS] or femoral neck [FN] between -2.5 and -4.0) or osteoporotic, with at least 1 mild baseline vertebral fracture.
V to študijo so bile vključene večinoma belke (87,3 %), ki so bodisi imele osteoporozo brez izhodiščnega zloma vretenc (ocena T na lestvici MKG na ledveni hrbtenici [LS] ali stegneničnem vratu [FN] med -2,5 in -4,0), bodisi so imele osteoporozo z vsaj enim blagim izhodiščnim zlomom vretenc.
The effect of bazedoxifene on BMD at other skeletal sites was similar.
Učinek bazedoksifena na MKG na drugih mestih v skeletu je bil podoben.
Very common(may affect more than 1 in 10 people):
Zelo pogosti(pojavijo se lahko pri več kot 1 od 10 bolnic):
In subjects with a fracture probability of 20% or greater (n = 618), the risk of non-vertebral fractures in bazedoxifene-treated subjects was decreased by 55% (95% CI: 18-76) compared to placebo-treated subjects.
Pri osebah z verjetnostjo zloma 20 % ali več (n = 618) se je nevarnost nevretenčnih zlomov pri osebah, zdravljenih z bazedoksifenom, v primerjavi z osebami, ki so prejemale placebo, zmanjšala za 55 % (95 % IZ: 18-76).
CONBRIZA is associated with an increased risk of venous thromboembolism (VTE).
Zdravilo CONBRIZA je povezano s povečanim tveganjem za pojav venske trombembolije (VTE).
Bazedoxifene acts as both an oestrogen-receptor agonist and/or antagonist, depending upon the cell and tissue type and target genes.
Bazedoksifen deluje kot oboje, agonist ali antagonist estrogenskih receptorjev, odvisno od vrste celic in tkiva in pa tarčnih genov.
Repeated-dose studies in normally cycling rodents and cynomolgus monkeys revealed a marked stimulation of ovarian follicle growth without ovulation, leading to partly haemorrhagic-ovarian cysts and markedly elevated estradiol levels.
Študije ponavljajočih se odmerkov pri glodalcih in opicah cinomolgus z normalnim ciklom so pokazale izrazito spodbujanje rasti ovarijskih foliklov brez ovulacije, kar povzroči nastanek delno hemoragičnih ovarijskih cist in izrazito zvišano koncentracijo estradiola.
No data are available on the concomitant use with agents used in the treatment of early or advanced breast cancer.
O sočasni uporabi z zdravili, ki se uporabljajo za zdravljenje zgodnjega ali napredovalega raka dojk, podatkov ni na voljo.
Safety and efficacy of bazedoxifene have not been evaluated in patients with hepatic impairment; use in this population is not recommended (see sections 4.4 and 5.2).
Pri bolnicah z okvaro jeter varnosti in učinkovitosti bazedoksifena niso ovrednotili; uporaba zdravila pri tej skupini bolnic ni priporočljiva (glejte poglavji 4.4 in 5.2).
The observation of benign, ovarian granulosa-cell tumours in female mice and rats administered bazedoxifene is a class effect of SERMs, related to its pharmacology in rodents when treated during their reproductive lives, when their ovaries are functional and responsive to hormonal stimulation.
Opaženi benigni ovarijski granulozocelularni tumorji pri mišjih in podganjih samicah, ki so prejemale bazedoksifen, je učinek skupine SERM, ki je povezan z njihovo farmakologijo pri samicah glodalcev, ki jih prejemajo v reproduktivni dobi, ko so njihovi jajčniki funkcionalni in se odzivajo na hormonsko stimulacijo.
Effects on the breast
Učinki na maternico
Negligible amounts of bazedoxifene were eliminated in urine.
Z urinom se je izločila zanemarljiva količina bazedoksifena.
if you have any vaginal bleeding while you take CONBRIZA, you should speak with your doctor.
če med jemanjem zdravila CONBRIZA začnete krvaveti iz nožnice, se morate pogovoriti z zdravnikom.
White to off-white, capsule-shaped, film-coated tablet debossed on one side with “WY20”.
Bela do sivobela, po obliki kapsuli podobna filmsko obložena tableta z napisom “WY20”, vtisnjenim na eni strani.
Bazedoxifene functions primarily as an oestrogen-receptor antagonist in uterine and breast tissues.
Bazedoksifen deluje primarno kot antagonist estrogenskih receptorjev v tkivih maternice in dojk.
In vitro data suggest that bazedoxifene is unlikely to interact with co-administered medicinal products via CYP-mediated metabolism.
Podatki in vitro kažejo, da je malo verjetno, da bazedoksifen medsebojno deluje s sočasno danimi zdravili preko presnove, ki jo uravnava CYP.
CONBRIZA has only been studied in women who have reached menopause, and therefore is not recommended.
Zdravilo CONBRIZA so raziskovali le pri ženskah, ki so dosegle menopavzo, zato ga pri ženskah pred menopavzo ne priporočamo.
Additionally, uterine wet weights were reduced compared with untreated animals and histologic evaluation demonstrated little to no difference from the untreated controls.
Poleg tega je bila vlažna teža maternice v primerjavi z živalmi, ki niso prejemale bazedoksifena, zmanjšana, histološki pregled pa je pokazal malo ali nič razlik med njimi in kontrolno skupino.
The disposition of a single 20 mg dose of bazedoxifene was compared in patients with hepatic impairment [Child-Pugh Class A (n=6), B (n=6), and C (n=6)] and subjects with normal hepatic function (n=18).
Primerjali so presnovo enkratnega 20 mg odmerka bazedoksifena pri bolnicah z okvaro jeter [razredi A (n = 6), B (n = 6) in C (n = 6) po Child-Pughovi lestvici] in bolnicah z normalnim delovanjem jeter (n = 18).
If you stop taking CONBRIZA
Če ste prenehali uporabljati zdravilo CONBRIZA
What CONBRIZA looks like and contents of the pack
Izgled zdravila CONBRIZA in vsebina pakiranja
Patients with hepatic impairment showed a 4.3-fold increase in area under the curve (AUC) [on average] compared with controls.
Bolnice z okvarami jeter so v primerjavi s kontrolno skupino pokazale 4,3-kratno zvečanje površine pod krivuljo (AUC) [povprečno].
CONBRIZA is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.
Zdravilo CONBRIZA je indicirano za zdravljenje postmenopavzalne osteoporoze pri ženskah z zvečanim tveganjem zlomov.
In the breast-density study, an ancillary study of the osteoporosis treatment study, 444 postmenopausal women (mean age = 59 years) with osteoporosis from all 4 treatment groups, were evaluated for mammographic breast density changes at 24 months.
V študiji preverjanja gostote dojk, stranski študiji ob študiji zdravljenja osteoporoze, je bilo ocenjenih 444 žensk v obdobju po menopavzi (povprečna starost = 59 let) z osteoporozo iz vseh 4 skupin zdravljenja, glede na spremembe v mamografski gostoti dojk po 24 mesecih.
Subjects with no baseline fracture n=757
Osebe brez izhodiščnih zlomov n = 757
On average, patients with hepatic impairment showed a 4.3-fold increase in AUC compared with controls.
Bolnice z okvaro jeter so v primerjavi s kontrolno skupino pokazale v povprečju 4,3-kratno zvečanje AUC.
Blood triglycerides increased, alanine aminotransferase increased, aspartate aminotransferase increased.
Preiskave zvišani trigliceridi v krvi, zvišana alaninaminotransferaza, zvišana aspartataminotransferaza
On average, compared to women 51 to 64 years of age (n=8), women 65 to 74 years of age (n=8) showed a 1.5-fold increase in AUC, and women 75 years of age (n=8) showed a 2.3-fold increase in AUC.
V primerjavi z ženskami, starimi 51 do 64 let (n = 8), so imele ženske, stare 65 do 74 let (n = 8), 1,5-krat večjo AUC, ženske, stare  75 let (n = 8), pa 2,3-krat večjo AUC.
If you take more CONBRIZA than you should
Če ste vzeli večji odmerek zdravila CONBRIZA, kot bi smeli
The effect on triglycerides in the bazedoxifene 20 mg and raloxifene 60 mg groups was similar to placebo.
Učinek na trigliceride v skupinah z bazedoksifenom v odmerku 20 mg in raloksifenom v odmerku 60 mg je bil podoben učinku placeba.
After 7 years of treatment with bazedoxifene the increases in BMD relative to placebo remained statistically significant at the femoral neck, femoral trochanter, and total hip.
Po sedmih letih zdravljenja z bazedoksifenom so povečanja MKG v primerjavi s placebom ostala statistično pomembna za stegnenični vrat, stegnenični trohanter in celoten kolk.
Subjects with 1 baseline fracture n=967
Osebe z ≥ 1 izhodiščnim zlomom n = 967
Like the rodent results, bazedoxifene treatment in non-human primates resulted in uterine and mammary gland atrophy without other histological differentiation from untreated animals.
Podobno kot pri glodalcih je dajanje bazedoksifena nehumanim primatom povzročilo atrofijo maternice in mlečnih žlez brez drugih histoloških razlik v primerjavi z živalmi, ki niso prejemale bazedoksifena.