natgillin/translations-raw huggingface dataset:
The decrease in oestrogen availability which occurs at menopause, leads to marked increases in bone resorption, bone loss and risk of fracture.
Zmanjšanje razpoložljivosti estrogena, ki nastopi ob menopavzi, povzro i znatno pove anje resorpcije kosti, izgubo kostne mase in pove anje nevarnosti za zlome kosti.
Bone loss is particularly rapid for the first 10 years after menopause when the compensatory increase in bone formation is inadequate to keep up with resorptive losses.
Izguba kostne mase je še posebej hitra v prvih 10 letih po menopavzi, ko proces kompenzacijskega pove anja tvorbe kostnega tkiva ne zadostuje, da bi nadomestil izgubo kostnega tkiva zaradi resorpcije.
In postmenopausal women with osteoporosis, OPTRUMA reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Pri ženskah po menopavzi, ki imajo osteoporozo, zdravilo OPTRUMA zmanjša incidenco zlomov vretenc, ohrani kostno maso in pove a mineralno kostno gostoto (BMD – bone mineral density).
Based on these risk factors, prevention of osteoporosis with OPTRUMA is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
Glede na naštete dejavnike tveganja je preventiva osteoporoze z zdravilom OPTRUMA indicirana v obdobju desetih let po nastopu menopavze pri tistih ženskah, ki imajo vrednosti BMD za hrbtenico za 1, 0 do 2, 5 SD nižje od srednje vrednosti zdrave mlade populacije, upoštevajo, da obstaja pri teh ženskah veliko tveganje za zlome kosti zaradi osteoporoze skozi vso nadaljnjo življenjsko dobo.
Likewise, OPTRUMA is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/ or with vertebral fractures, irrespective of BMD.
Podobno velja, da je zdravilo OPTRUMA indicirano za zdravljenje osteoporoze ali ugotovljene osteoporoze pri ženskah, ki imajo vrednosti BMD za hrbtenico za 2, 5 SD nižje od srednje vrednosti zdrave mlade populacije in/ ali imajo zlome vretenc, ne glede na vrednosti BMD.
Forty five women with osteoporosis or 15 women with
V raziskavi pri 7. 705 ženskah po menopavzi s srednjo starostjo 66 let in z osteoporozo je 3- letno zdravljenje z zdravilom OPTRUMA zmanjšalo incidenco zlomov vretenc za 47% (relativno tveganje (RR) 0, 53 pri 95% intervalu zaupanja (CI) 0, 35– 0, 79; p < 0, 001), pri ženskah z osteoporozo in obstoje im zlomom pa je bila incidenca zlomov vretenc zmanjšana za 31% (RR 0, 69 pri 95% CI 0, 56– 0, 86; p < 0, 001).
7 osteoporosis with an existing fracture would need to be treated with OPTRUMA for 3 years to prevent one or more vertebral fractures.
Da bi prepre ili enega ali ve zlomov vretenc, bi bilo treba z zdravilom OPTRUMA zdraviti petinštirideset žensk z osteoporozo ali 15 žensk z osteoporozo in obstoje im zlomom 3 leta.
OPTRUMA treatment for 4 years reduced the incidence of vertebral fractures by 46% (RR 0.54, CI 0.38, 0.75) and 32% (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Štiriletno zdravljenje z zdravilom OPTRUMA je pri bolnicah z osteoporozo zmanjšalo incidenco zlomov vretenc za 46% (RR 0, 54 pri 95% CI 0, 38– 0, 75), pri bolnicah z osteporozo in obstoje im zlomom pa je incidenca zmanjšana za 32% (RR 0, 68 pri 95% CI 0, 56– 0, 83).
In the 4th year alone, OPTRUMA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
Samo v etrtem letu zdravljenja je prejemanje zdravila OPTRUMA znižalo tveganje za nov zlom vretenca za 39% (RR 0, 61 pri 95% CI 0, 43– 0, 88).
An effect on non-vertebral fractures has not been demonstrated.
Vpliva na nevreten ne zlome niso dokazali.
From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin and fluorides and all patients in this study received calcium and vitamin D supplementation.
Od etrtega do osmega leta zdravljenja so bolnicam dovolili so asno jemanje difosfonatov, kalcitonina in fluoridov in vse bolnice iz te raziskave so jemale dodatke kalcija in vitamina D.
In the RUTH study overall clinical fractures were collected as a secondary endpoint.
V študiji RUTH so kot sekundarni cilj zbirali podatke o celotnih klini nih zlomih.
Optruma reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47 0.89).
Optruma je zmanjšala incidenco klini nih zlomov vretenc za 35% v primerjavi s placebom (HR 0, 65, CI 0, 47 – 0, 89).
During the whole length of the study concomitant use of other bone-active medications was permitted.
Med celotnim trajanjem študije je bila dovoljena so asna uporaba drugih zdravil, ki u inkujejo na kosti.
The efficacy of OPTRUMA once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
U inkovitost zdravljenja z zdravilom OPTRUMA enkrat dnevno so ugotavljali pri ženskah po menopavzi, starih do 60 let, z maternico ali brez nje, in sicer med 2 - letnim zdravljenjem s tem zdravilom.
Three trials included 1,764 postmenopausal women who were treated with OPTRUMA and calcium or calcium supplemented placebo.
V treh klini nih preskušanjih je sodelovalo 1. 764 žensk po menopavzi, ki so bile zdravljene z zdravilom OPTRUMA in dodatki kalcija ali s placebom in dodatki kalcija.
OPTRUMA produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
Zdravilo OPTRUMA je povzro ilo zna ilno pove anje kostne gostote v kolku in hrbtenici, pa tudi zna ilno pove anje celotne kostne mineralne mase v telesu v primerjavi s placebom.
This increase was generally a 2% increase in BMD compared to placebo.
Na splošno je šlo za 2- odstotno pove anje BMD v primerjavi s placebom.
A similar increase in BMD was seen in the treatment population who received OPTRUMA for up to 7 years.
Podobno pove anje BMD so ugotovili pri zdravljeni populaciji, ki je prejemala zdravilo OPTRUMA do 7 let.
In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37% decreased and 63% increased; and for the total hip 29% decreased and 71% increased.
V preskušanjih preventive osteoporoze z zdravilom OPTRUMA so bili odstotki preiskovank, pri katerih so ugotovili pove anje ali zmanjšanje BMD med terapijo z raloksifenom, naslednji: za hrbtenico so pri 37% preiskovank ugotovili zmanjšanje in pri 63% pove anje BMD; za celoten kolk so pri 29% ugotovili zmanjšanje in pri 71% pove anje BMD.
OPTRUMA and oestrogen affect bone remodelling and calcium metabolism similarly.
Uporaba zdravila OPTRUMA je bila povezana z zmanjšano
OPTRUMA was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
8 resorpcijo kostnega tkiva in s srednjim pozitivnim premikom ravnotežja kalcija za 60 mg na dan, kar je bilo predvsem posledica zmanjšane izgube kalcija z urinom.
In a study comparing OPTRUMA with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
V raziskavi, v kateri so zdravilo OPTRUMA primerjali z estrogenom, so ugotavljali, da je pri obeh zdravilih kostno tkivo zdravljenih bolnic histološko normalno in da ni nobenih znakov defektov v mineralizaciji kosti, kostnega spleta ali fibroze kostnega mozga.
Raloxifene decreases resorption of bone; this effect on bone is manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in BMD and decreases in the incidence of fractures.
Ta u inek na kosti se kaže v obliki znižanja koncentracije indikatorjev kostne presnove v serumu in urinu, zmanjšanja resorpcije kosti, ugotovljenega na podlagi raziskav kinetike radiološko ozna enega kalcija, pove anja BMD in v obliki zmanjšanja incidence zlomov.
b) Effects on lipid metabolism and cardiovascular risk
b) Vplivi na presnovo lipidov in sr nožilno tveganje
Clinical trials showed that a 60 mg daily dose of OPTRUMA significantly decreased total cholesterol (3 to 6%), and LDL cholesterol (4 to 10%).
Klini ne raziskave so pokazala, da dnevni odmerek zdravila OPTRUMA 60 mg zna ilno zniža vrednosti skupnega holesterola (3 do 6%) in LDL holesterola (4 do 10%).
Women with the highest baseline cholesterol levels had the greatest decreases.
To znižanje je bilo najve je pri ženskah z najvišjimi za etnimi vrednostmi holesterola.
HDL cholesterol and triglyceride concentrations did not change significantly.
Koncentracije HDL holesterola in trigliceridov se niso zna ilno spremenile.
After 3 years therapy OPTRUMA decreased fibrinogen (6.71%).
Po 3 letih terapije z zdravilom OPTRUMA je znižana vrednost fibrinogena (6, 71%).
In the osteoporosis treatment study, significantly fewer OPTRUMA-treated patients required initiation of hypolipidaemic therapy compared to placebo.
V študiji zdravljenja osteoporoze je bila pri bolnicah, zdravljenih z zdravilom OPTRUMA, uvedba hipolipemi ne terapije potrebna pri zna ilno manjšem številu v primerjavi s placebom.
OPTRUMA therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Osemletno zdravljenje z zdravilom OPTRUMA pri bolnicah, vklju enih v študijo zdravljenja osteoporoze, ni zna ilno vplivalo na tveganje za sr nožilne dogodke.
Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
Podobno v študiji RUTH raloksifen v primerjavi s placebom ni vplival na incidenco miokardnega infarkta, hospitalizacije akutnega koronarnega sindroma, kapi ali celokupno smrtnost, vklju no s celokupno kardiovaskularno smrtnostjo (za pove anje tveganja smrtne kapi glejte poglavje 4. 4).
8 The relative risk of venous thromboembolic events observed during raloxifene treatment was 1.60 (CI 0.95, 2.71) when compared to placebo, and was 1.0 (CI 0.3, 6.2) when compared to oestrogen or hormonal replacement therapy.
Relativno tveganje za venske tromboemboli ne zaplete, ki so jih ugotovili med zdravljenjem z raloksifenom, je bilo RR 1, 60 (CI 0, 95, 2, 71) v primerjavi s placebom, in RR 1, 0 (95% CI 0, 3– 6, 2) v primerjavi z estrogensko ali hormonsko nadomestno terapijo.
The risk of a thromboembolic event was greatest in the first four months of therapy.
Tveganje za tromboemboli ne zaplete je bilo najve je v prvih štirih mesecih terapije.
c) Effects on the endometrium and on the pelvic floor
c) Vplivi na endometrij in medeni no dno
In clinical trials, OPTRUMA did not stimulate the postmenopausal uterine endometrium.
V klini nih preskušanjih zdravilo OPTRUMA ni stimuliralo postmenopavzalnega materni nega endometrija.
Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Prou ili so rezultate skoraj 3. 000 transvaginalnih ultrazvo nih preiskav pri 831 ženskah iz vseh skupin odmerjanja.
Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
Pri ženskah, zdravljenih z raloksifenom, ves as ni bilo razlike v debelini endometrija v primerjavi z debelino endometrija pri tistih, ki so prejemale placebo.
After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9% of the 211 women treated with raloxifene 60 mg/ day compared to 1.8% of the 219 women who received placebo.
Pri 1, 9% od 211 žensk, ki so jih zdravili z raloksifenom v odmerku 60 mg na dan, so po 3 letih zdravljenja ugotovili najmanj 5- milimetrsko pove anje debeline endometrija, kar so ugotavljali s transvaginalnim ultrazvokom, v primerjavi z 1, 8% od 219 žensk, ki so prejemale placebo.
There were no differences between the raloxifene and placebo groups with respect to the incidence of reported uterine bleeding.
Glede incidence krvavitve iz maternice v poro ilih ni bilo razlik med skupino, ki je jemala raloksifen, in tisto, ki je prejemala placebo.
Endometrial biopsies taken after six months therapy with OPTRUMA 60 mg daily demonstrated non- proliferative endometrium in all patients.
Biopsija endometrija po šestih mesecih terapije z zdravilom OPTRUMA v odmerku 60 mg na dan je pri vseh bolnicah pokazala neproliferativni endometrij.
In addition, in a study with 2.5 x the recommended daily dose of OPTRUMA there was no evidence of endometrial proliferation and no increase in uterine volume.
Poleg tega v raziskavi z 2, 5- kratnim priporo enim dnevnim odmerkom zdravila OPTRUMA ni bilo nobenih znakov proliferacije endometrija in niso ugotovili pove anja prostornine maternice.
Endometrial thickness measurements in OPTRUMA treated women were not different from baseline after 4 years of therapy.
Meritve debeline endometrija pri ženskah, ki so bile zdravljene z zdravilom OPTRUMA, se po 4 letih terapije niso razlikovale od za etnih vrednosti.
There was no difference between OPTRUMA and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Tudi ni bilo razlike med ženskami, zdravljenimi z zdravilom OPTRUMA, in
Fewer OPTRUMA treated women than placebo treated women required surgical intervention for uterine prolapse.
V skupini, zdravljeni z zdravilom OPTRUMA, je manj žensk potrebovalo kirurški poseg zaradi prolapsa maternice kot v skupini, ki je prejemala placebo.
Safety information following 3 years of raloxifene treatment suggests that raloxifene treatment does not increase pelvic floor relaxation and pelvic floor surgery.
Podatki o varnosti po 3 letih zdravljenja z raloksifenom kažejo, da slednje ne pove a pojavnosti popuš anja medeni nega dna in operacijskih posegov na medeni nem dnu.
After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
Po 4 letih raloksifen ni pove al tveganja za nastanek raka endometrija ali raka jaj nikov.
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
Pri ženskah po menopavzi, ki so se 4 leta zdravile z raloksifenom, so poro ali o benignih polipih endometrija pri 0, 9% bolnic v primerjavi z 0, 3% bolnic, ki so prejemale placebo.
OPTRUMA does not stimulate breast tissue.
Zdravilo OPTRUMA ne stimulira tkiva dojk.
Across all placebo-controlled trials, OPTRUMA was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
V vseh s placebom nadzorovanih preskušanjih vpliva zdravljenja z zdravilom OPTRUMA ni bilo mogo e razlikovati od vpliva placeba, kar zadeva pogostnost in stopnjo simptomov v zvezi z dojkami (brez nabrekanja, ob utljivosti in bole in v dojkah).
Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), OPTRUMA treatment compared to placebo reduced the risk of total breast cancer by 62% (RR 0.38; CI 0.21, 0.69), the risk of invasive breast cancer by 71% (RR 0.29, CI 0.13, 0.58) and the risk of invasive oestrogen receptor (ER) positive breast cancer by 79% (RR 0.21, CI 0.07, 0.50).
V ve kot 4 letih preskušanja zdravljenja osteoporoze, ki je vklju evalo 7. 705 bolnic, je zdravljenje z zdravilom OPTRUMA v primerjavi s placebom zmanjšalo tveganje za vse vrste raka dojke za 62% (RR 0, 38 pri 95% CI 0, 21– 0, 69), tveganje za invazivni rak dojke za 71% (RR 0, 29 pri 95% CI 0, 13 – 0, 58) ter tveganje za invazivni rak dojke, pozitiven za estrogenske receptorje (ER), za 79% (RR 0, 21 pri 95% CI 0, 07– 0, 50).
OPTRUMA has no effect on the risk of ER negative breast cancers.
Zdravilo OPTRUMA ne vpliva na tveganje za ER negativne vrste raka dojke.
No adverse effects on cognitive function have been seen.
Opazili niso nobenih neželenih u inkov na kognitivno funkcijo.
9 5.2 Pharmacokinetic properties
5. 2 Farmakokineti ne lastnosti
The time to reach average maximum plasma concentration and bioavailability are functions of systemic interconversion and enterohepatic cycling of raloxifene and its glucuronide metabolites.
Njegova absolutna biološka uporabnost je 2%. as, potreben, da raloksifen doseže povpre ne vrednosti maksimalne plazemske koncentracije in biološke uporabnosti, je odvisen od sistemske interkonverzije ter enterohepati ne cirkulacije raloksifena in njegovih glukuronidnih presnovkov.
Raloxifene is strongly bound to plasma proteins (98-99%).
Raloksifen se mo no veže na plazemske beljakovine (98– 99%).
Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4 '- glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′ -diglucuronide.
Raloksifen se že pri prvem prehodu skozi jetra v veliki meri presnovi v glukuronidne konjugate: raloksifen- 4 '- glukuronid, raloksifen- 6- glukuronid in raloksifen- 6, 4' - diglukuronid.
Raloxifene comprises less than 1% of the combined concentrations of raloxifene and the glucuronide metabolites.
Koli ina samega raloksifena je manjša od 1% celotnega seštevka koncentracij raloksifena in njegovih glukuronidnih presnovkov.
Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Koncentracija raloksifena se vzdržuje z enterohepati no cirkulacijo, zato je njegov plazemski razpolovni as 27, 7 ure.
Results from single oral doses of raloxifene predict multiple dose pharmacokinetics.
Rezultati meritev po dajanju enega samega peroralnega odmerka raloksifena napovedujejo farmakokinetiko ve odmerkov.
Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
Pove evanje odmerkov raloksifena povzro i nekaj manj kot sorazmerno pove anje površine pod krivuljo plazemske koncentracije po asu (AUC).
Excretion
10 Izlo anje
The majority of a dose of raloxifene and glucuronide metabolites are excreted within 5 days and are found primarily in the faeces, with less than 6% excreted in urine.
Ve ji del odmerka raloksifena in njegovih glukuronidnih presnovkov se izlo i v roku 5 dni in jih najdemo predvsem v blatu, manj kot 6% pa se jih izlo i z urinom.
Renal insufficiency - Less than 6% of the total dose is eliminated in urine.
Ledvi na insuficienca – Manj kot 6% celotnega odmerka se izlo i z urinom.
In a population pharmacokinetic study, a 47% decrease in lean body mass adjusted creatinine clearance resulted in a 17% decrease in raloxifene clearance and a 15% decrease in the clearance of raloxifene conjugates.
V populacijski farmakokineti ni raziskavi je 47% znižanje o istka kreatinina, prilagojenega telesni masi brez maš evja, povzro ilo 17% znižanje o istka raloksifena in 15% znižanje o istka konjugatov raloksifena.
In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/ theca cell origin was observed in high-dose females (279 mg/ kg/ day).
V 2- letni raziskavi kancerogenosti zdravila na podganah so pri samicah, ki so prejemale visoke odmerke (279 mg/ kg/ dan), ugotovili pove anje pogostnosti pojava tumorjev ovarija, ki so izvirali iz granulozne ali tekalne plasti celic ovarijskih foliklov.
Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Sistemska izpostavljenost raloksifenu (AUC) v tej skupini preiskovanih podgan je bila približno 400- krat ve ja od vrednosti za ženske po menopavzi, ki dobi odmerek 60 mg.
In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/ kg, and prostatic leiomyoblastoma in males given 210 mg/ kg.
V 21- mese ni raziskavi kancerogenosti na miših so ugotavljali pove ano incidenco tumorjev testisa, ki so izvirali iz intersticijskih celic, adenomov prostate in adenokarcinomov pri samcih, ki so prejemali odmerke 41 ali 210 mg/ kg, ter leiomioblastoma prostate pri samcih, ki so prejemali odmerke 210 mg/ kg.
In female mice, an increased incidence of ovarian tumours in animals given 9 to 242 mg/ kg (0.3 to 32 times the AUC in humans) included benign and malignant tumours of granulosa/ theca cell origin and benign tumours of epithelial cell origin.
Pri mišjih samicah je pove ana incidenca ovarijskih tumorjev pri tistih živalih, ki so prejele 9 do 242 mg/ kg (0, 3 - do 32- kratne AUC za loveka), vklju evala tako benigne kot maligne tumorje, ki so izvirali iz granulozne ali tekalne plasti celic ovarijskih foliklov, ter benigne tumorje epitelijskega izvora.
The female rodents in these studies were treated during their reproductive lives, when their ovaries were functional and highly responsive to hormonal stimulation.
Glodavske samice, ki so bile vklju ene v te raziskave, so zdravilo prejemale v rodni dobi, ko so njihovi ovariji še delovali in so se mo no odzivali na stimulacijo s hormoni.
In contrast to the highly responsive ovaries in this rodent model, the human ovary after menopause is relatively unresponsive to reproductive hormonal stimulation.
V nasprotju z mo no odzivnimi ovariji v tem glodavskem modelu pa je loveški (t. j. ženski) ovarij po menopavzi sorazmerno neodziven na stimulacijo s spolnimi hormoni.
10 Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
Z nobenim od velikega števila uporabljenih testnih sistemov niso ugotavljali genotoksi nih u inkov raloksifena.
The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Reproduktivni in razvojni u inki, ki so jih opažali pri živalih, so v skladu z znanim farmakološkim profilom raloksifena.
At doses of 0.1 to 10 mg/ kg/ day in female rats, raloxifene disrupted estrous cycles of female rats during treatment, but did not delay fertile matings after treatment termination and only marginally reduced litter size, increased gestation length, and altered the timing of events in neonatal development.
Pri odmerkih od 0, 1 do 10 mg/ kg/ dan pri podganjih samicah je raloksifen povzro il motnje ovarijskega ciklusa med zdravljenjem, ne pa zakasnitve plodnega parjenja po prenehanju zdravljenja.
When given during the preimplantation period, raloxifene delayed and disrupted embryo implantation resulting in prolonged gestation and reduced litter size but development of offspring to weaning was not affected.
Povzro il je le mejno zmanjšanje števila mladi ev in podaljšanje gestacije ter spremenil mejna razvojna obdobja v asu neonatalnega razvoja. e so raloksifen dali v asu pred implantacijo, je zakasnil implatancijo embrija, povzro il motnje pri implatanciji in posledi no podaljšano gestacijo ter zmanjšanje števila mladi ev, vendar pa razvoj mladi ev do odstavitve ni bil moten.
Teratology studies were conducted in rabbits and rats.
Raziskave teratogenih u inkov so opravili na kuncih in podganah.
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/ kg).
Pri podganah so se pojavili zastoj razvoja ploda, valovita rebra in ledvi ne ciste (≥ 1 mg/ kg).
Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Raloksifen deluje na podganji uterus kot mo an antiestrogen in je prepre il rast od estrogena odvisnih tumorjev dojke pri podganah in miših.
Shellac Propylene glycol Indigo carmine (E 132)
rnilo: šelak propilenglikol indigotin (E132)
OPTRUMA tablets are packed either in PVC/ PE/ PCTFE blisters or in high density polyethylene bottles.
Tablete OPTRUMA so pakirane v pretisne omote Aclar ali v stekleni ke iz polietilena visoke gostote.
Bottles contain 100 tablets.
Stekleni ke vsebujejo po 100 tablet.
11 Not all pack sizes may be marketed in all countries.
V vseh državah na trgu ni vseh navedenih pakiranj.
Eli Lilly Nederland B. V Grootslag 1-5 NL-3991 RA Houten The Netherlands
Eli Lilly Nederland B. V Grootslag 1- 5 NL- 3991 RA Houten Nizozemska
5 August 2003
5. avgust 2003
13 A.
13 DODATEK II