FrancophonIA/ELRC3.0 huggingface dataset:
English: The table below gives the adverse reactions and frequencies observed in treatment and prevention studies involving over 13,000 postmenopausal women along with adverse reactions arising from postmarketing reports.
Slovenian: Spodnja tabela prikazuje neželene učinke in pogostnosti, ki so jih opazili v študijah zdravljenja in preprečevanja, v katerih je sodelovalo več kot 13.000 postmenopavzalnih žensk, vključno z neželenimi učinki iz poročil v obdobju trženja.Zdravljenje v teh študijah je trajalo od 6 do 60 mesecev.
English: What Evista looks like and contents of the pack Evista are white, oval, film coated tablets which are marked with the number 4165.
Slovenian: Evista so bele, ovalne, filmsko obložene tablete, ki so označene s številko 4165.
English: Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
Slovenian: V primerjavi s placebom uporaba raloksifena ni pokazala povezave s krvavim izcedkom, krvavitvami ali hiperplazijo endometrija.
English: Driving and using machines Evista has no or negligible effects on driving or using machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Evista nima učinkov ali ima zanemarljive učinke na vožnjo ali upravljanje s stroji.
English: A similar frequency of increases was noted among placebo patients.
Slovenian: Podobno pogostnost zvišanja so opazili tudi pri bolnicah, ki so prejemale placebo.
English: Marketing Authorisation Holder Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, D-81379 Munich, Germany.
Slovenian: Imetnik dovoljenja za promet z zdravilom Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, D-81379 Muenchen, Nemčija.
English: Compared to placebo there was no increased use in Evista treated patients.
Slovenian: V primerjavi s placebom ni bila opažena povečana uporaba pri bolnicah, zdravljenih z zdravilom Evista.
English: In rare cases, blood levels of liver enzymes may increase during treatment with Evista.
Slovenian: V redkih primerih se lahko med zdravljenjem z zdravilom Evista zvišajo koncentracije jetrnih encimov v krvi.
English: In clinical trials, Evista did not stimulate the postmenopausal uterine endometrium.
Slovenian: V kliničnih preskušanjih zdravilo Evista ni stimuliralo postmenopavzalnega materničnega endometrija.
English: Across all placebo-controlled trials, Evista was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
Slovenian: V vseh s placebom nadzorovanih preskušanjih vpliva zdravljenja z zdravilom Evista ni bilo mogoče razlikovati od vpliva placeba, kar zadeva pogostnost in stopnjo simptomov v zvezi z dojkami (brez nabrekanja, občutljivosti in bolečin v dojkah).
English: There is no relevant use of Evista in the paediatric population.
Slovenian: Uporaba zdravila Evista ni primerna pri pediatrični populaciji.
English: Therefore, Evista should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Slovenian: Zdravilo Evista se za zdravljenje in preprečevanje osteoporoze lahko uporablja le po zaključenem zdravljenju raka dojke, vključno z vso spremljajočo terapijo.
English: Evista should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
Slovenian: Zdravilo Evista je treba prenehati jemati pri katerikoli bolezni ali motnji, ki vodi do daljše imobilizacije bolnice.
English: Evista does not stimulate breast tissue.
Slovenian: Zdravilo Evista ne stimulira tkiva dojk.
English: 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).
Slovenian: Podobno v študiji RUTH raloksifen v primerjavi s placebom ni vplival na incidenco miokardnega infarkta, hospitalizacije akutnega koronarnega sindroma, kapi ali celokupno smrtnost, vključno s celokupno kardiovaskularno smrtnostjo (za povečanje tveganja smrtne kapi glejte poglavje 4.4).
English: PHARMACEUTICAL FORM AND CONTENTS 14 film coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 filmsko obloženih tablet
English: In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/kg) and hydrocephaly (≥ 10 mg/kg) were seen.
Slovenian: Pri kuncih so opažali splave, majhno pogostnost defektov ventrikularnega septuma (≥ 0,1 mg/kg) in hidrocefalijo (≥ 10 mg/kg).
English: Musculoskeletal and connective tissue disorders Common: Leg cramps
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti: krči v nogah
English: 84 film coated tablets
Slovenian: 84 filmsko obloženih tablet
English: PHARMACEUTICAL FORM AND CONTENTS 100 film coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 100 filmsko obloženih tablet
English: There was no difference between treatment groups in the incidence of new nonvertebral fractures.
Slovenian: V incidenci novih nevretenčnih zlomov ni bilo razlik med zdravljenimi skupinami.
English: • If you have any further questions, ask your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja se posvetujte z zdravnikom ali farmacevtom.
English: Endometrial thickness measurements in Evista treated women were not different from baseline after 4 years of therapy.
Slovenian: Meritve debeline endometrija pri ženskah, ki so bile zdravljene z zdravilom Evista, se po 4 letih terapije niso razlikovale od začetnih vrednosti.
English: Based on these risk factors, prevention of osteoporosis with Evista 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.
Slovenian: Glede na naštete dejavnike tveganja je preventiva osteoporoze z zdravilom Evista 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, upoštevajoč, da obstaja pri teh ženskah veliko tveganje za zlome kosti zaradi osteoporoze skozi vso nadaljnjo življenjsko dobo.
English: Evista therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Slovenian: Osemletno zdravljenje z zdravilom Evista pri bolnicah, vključenih v študijo zdravljenja osteoporoze, ni značilno vplivalo na tveganje za srčnožilne dogodke.
English: In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0 % or 3.88 cases per 1,000 patient-years in the raloxifene group and 1.4 % or 2.70 cases per 1,000 patient-years in the placebo group.
Slovenian: V študiji RUTH so se venski tromboembolični zapleti pojavljali v približno 2,0 % ali 3,88 primerih na 1.000 bolnških let v skupini raloksifena in 1,4 % ali 2,70 primerih na 1.000 bolnških let v skupini placeba.
English: In postmenopausal women with osteoporosis, Evista reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Slovenian: Pri ženskah po menopavzi, ki imajo osteoporozo, zdravilo Evista zmanjša incidenco zlomov vretenc, ohrani kostno maso in poveča mineralno kostno gostoto (BMD - bone mineral density).
English: Therefore Evista is not recommended to be used in patients with hepatic insufficiency.
Slovenian: Zato uporabe zdravila Evista ne priporočamo pri bolnicah z jetrno insuficienco.
English: Warnings and precautions Talk to your doctor or pharmacist before you take Evista.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Evista se posvetujte z zdravnikom ali farmacevtom.
English: During an average follow-up of 5.6 years, 59 (1.2%) raloxifene-treated women died due to a stroke compared to 39 (0.8%) placebo-treated women.
Slovenian: Med povprečnim spremljanjem 5,6 let je 59 (1,2 %) žensk, ki so se zdravile z raloksifenom in 39 (0,8 %) žensk, ki so se zdravile s placebom, umrlo zaradi kapi.
English: What Evista is and what it is used for What you need to know before you take Evista How to take Evista
Slovenian: Kaj je zdravilo Evista in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Evista Kako jemati zdravilo Evista Možni neželeni učinki
English: The frequencies for postmarketing reports were calculated from placebo-controlled clinical trials (comprising a total of 15,234 patients, 7,601 on raloxifene 60 mg and 7,633 on placebo) in postmenopausal women with osteoporosis, or established coronary heart disease (CHD) or increased risk for CHD, without comparison to the frequencies of adverse events in the placebo assignment groups.
Slovenian: Pogostnosti za poročila v obdobju trženja so bile preračunane iz placebo nadzorovanih kliničnih preskušanj (v katera je bilo vključenih 15234 bolnic, 7601 jih je prejemalo 60 mg raloksifena in 7633 jih je prejemalo placebo) pri postmenopavzalnih ženskah z osteoporozo, ugotovljeno koronarno boleznijo srca (CHD) ali s povečanim tveganjem za CHD, brez primerjave s pogostnostmi neželenih učinkov v placebo skupini.
English: 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.
Slovenian: Pri mišjih samicah je povečana incidenca ovarijskih tumorjev pri tistih živalih, ki so prejele 9 do 242 mg/kg (0,3- do 32-kratne AUC za človeka), vključevala tako benigne kot maligne tumorje, ki so izvirali iz granulozne ali tekalne plasti celic ovarijskih foliklov, ter benigne tumorje epitelijskega izvora.
English: Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Slovenian: Med zdravljenjem je treba skrbno spremljati vrednosti serumskih koncentracij celokupnega bilirubina, gama-glutamil transferaze, alkalne fosfataze, ALT in AST, če pri bolnici ugotovimo zvišane vrednosti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER BOX FILM COATED TABLETS:
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA S PRETISNIM OMOTOM S FILMSKO OBLOŽENIMI TABLETAMI:
English: In the osteoporosis treatment study, significantly fewer Evista-treated patients required initiation of hypolipidaemic therapy compared to placebo.
Slovenian: V študiji zdravljenja osteoporoze je bila pri bolnicah, zdravljenih z zdravilom Evista, uvedba hipolipemične terapije potrebna pri značilno manjšem številu v primerjavi s placebom.
English: Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin (CBG), with corresponding increases in total hormone concentrations.
Slovenian: Raloksifen zmerno poveča koncentracije globulinov, na katere se vežejo hormoni, vključno z globulini, na katere se vežejo steroidni spolni hormoni, globulini, na katere se veže tiroksin, in globulini za vezavo kortikosteroidov, kar povzroči ustrezno povečanje skupne koncentracije hormonov.
English: 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.
Slovenian: V preskušanjih preventive osteoporoze z zdravilom Evista so bili odstotki preiskovank, pri katerih so ugotovili povečanje ali zmanjšanje BMD med terapijo z raloksifenom, naslednji: za hrbtenico so pri 37 % preiskovank ugotovili zmanjšanje in pri 63 % povečanje BMD; za celoten kolk so pri 29 % ugotovili zmanjšanje in pri 71 % povečanje BMD.
English: Evista should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Slovenian: Jetrna okvara: Zdravila Evista ne smemo uporabljati pri bolnikih z jetrno okvaro (glejte poglavje 4.3 in 4.4).
English: Evista should not be used in patients with severe renal impairment (see section 4.3).
Slovenian: Zdravila Evista ne smemo uporabljati pri bolnikih s hudo ledvično okvaro (glejte poglavje 4.3).
English: Flu syndrome was reported by 16.2 % of Evista treated patients and 14.0 % of placebo treated patients.
Slovenian: O sindromu gripe so poročali pri 16,2 % bolnic, zdravljenih z zdravilom Evista, in pri 14,0 % bolnic, ki so jemale placebo.
English: If you take more Evista than you should you could have leg cramps and dizziness.
Slovenian: Če ste vzeli večji odmerek zdravila Evista, kot bi smeli, se pri vas lahko pojavijo krči v nogah ali omotica.
English: Evista produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
Slovenian: Zdravilo Evista je povzročilo značilno povečanje kostne gostote v kolku in hrbtenici, pa tudi značilno povečanje celotne kostne mineralne mase v telesu v primerjavi s placebom.
English: The incidence of stroke mortality was 2.2 per 1,000 women per year for raloxifene versus 1.5 per 1,000 women per year for placebo (see section 4.4).
Slovenian: Pogostnost smrtnosti zaradi kapi je bila 2,2 na 1000 žensk na leto za raloksifen proti 1,5 na 1000 žensk na leto za placebo (glejte poglavje 4.4).
English: The safety of Evista in patients with breast cancer has not been adequately studied.
Slovenian: Zadostnih študij o varnosti zdravila Evista pri bolnicah z rakom dojke ni.
English: Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in Evista patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3 % Evista and 18.2 % placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6 % for Evista and 7.1 % placebo).
Slovenian: V primerjavi z bolnicami, ki so prejemale placebo, je bila pogostnost pojavov vazodilatacije (navali vročine) zmerno povečana pri bolnicah, zdravljenih z zdravilom Evista (pri kliničnih preskušanjih za preventivo osteoporoze, trajanje menopavze 2 do 8 let - 24,3 % pri zdravilu Evista in 18,2 % pri placebu; pri kliničnih raziskavah za zdravljenje osteoporoze, povprečna starost 66 let - 10,6 % pri zdravilu Evista in 7,1 % pri placebu).
English: There was no difference between Evista and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Slovenian: Tudi ni bilo razlike med ženskami, zdravljenimi z zdravilom Evista, in tistimi, ki so prejemale placebo, kar zadeva incidenco vaginalne krvavitve (krvavega izcedka) ali izcedka iz nožnice.
English: c) Effects on the endometrium and on the pelvic floor
Slovenian: c) Vplivi na endometrij in medenično dno
English: NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Daiichi Sankyo Europe GmbH
English: 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.
Slovenian: Pri ženskah po menopavzi, ki so bile 4 leta zdravljene z raloksifenom, so poročali o benignih polipih endometrija v 0,9 % primerov v primerjavi z 0,3 % primerov pri ženskah, ki so prejemale le placebo.
English: NAME OF THE MEDICINAL PRODUCT Evista 60 mg film coated tablets
Slovenian: IME ZDRAVILA Evista 60 mg filmsko obložene tablete
English: Evista does not treat postmenopausal symptoms, such as hot flushes.
Slovenian: Zdravilo Evista ne zdravi postmenopavzalnih simptomov, kakor so navali vročine.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za peroralno uporabo.
English: 28 film coated tablets
Slovenian: 28 filmsko obloženih tablet
English: Evista lowers total cholesterol and LDL ("bad") cholesterol.
Slovenian: Zdravilo Evista znižuje vrednost celokupnega holesterola in LDL ('slabega') holesterola.
English: See leaflet for further information
Slovenian: Za nadaljnje informacije glejte navodilo.
English: This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1 % for Evista and 1.9 % for placebo; and in the treatment population occurred at an incidence of 7.1 % for Evista and 6.1 % for placebo.
Slovenian: To je bil periferni edem, ki se je v skupini, pri kateri so raloksifen uporabljali za preventivo, pojavljal z incidenco 3,1 % za zdravilo Evista in 1,9 % za placebo ter v skupini, pri kateri so raloksifen uporabljali za zdravljenje, z incidenco 7,1 % za zdravilo Evista in 6,1 % za placebo.
English: Evista reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47
Slovenian: Zdravilo Evista je zmanjšalo incidenco kliničnih zlomov vretenc za 35 % v primerjavi s placebom (HR 0,65, CI 0,470,89).
English: Common: Headache, including migraine a
Slovenian: Pogosti: glavobol, vključno z migrenoa
English: How to store Evista
Slovenian: Kako jemati zdravilo Evista
English: The majority of side effects seen with Evista have been mild.
Slovenian: Neželeni učinki, ki so jih opažali pri zdravilu Evista, so bili večinoma blagi.
English: In the 4th year alone, Evista reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Slovenian: Samo v četrtem letu zdravljenja je prejemanje zdravila Evista znižalo tveganje za nov zlom vretenca za 39 % (RR 0,61 pri 95 % CI 0,43-0,88).
English: a) Skeletal Effects
Slovenian: a) Vplivi na okostje
English: In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/kg).
Slovenian: Pri podganah so se pojavili zastoj razvoja ploda, valovita rebra in ledvične ciste (≥ 1 mg/kg).
English: Another adverse reaction observed was leg cramps (5.5 % for Evista, 1.9 % for placebo in the prevention population and 9.2 % for Evista, 6.0 % for placebo in the treatment population).
Slovenian: Naslednji opaženi neželeni učinek so bili krči v nogah (5,5 % pri zdravilu Evista in 1,9 % pri placebu v skupini, v kateri so raloksifen uporabljali za preventivo, ter 9,2 % pri zdravilu Evista in 6,0 % pri placebu v skupini, v kateri so raloksifen uporabljali za zdravljenje).
English: Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
Slovenian: Ženskam, ki s hrano vnašajo majhne količine kalcija in vitamina D, na splošno svetujemo, naj jemljejo dodatke kalcija in vitamina D.
English: Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Slovenian: Zdravilo Evista je indicirano za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.
English: Propylene glycol Indigo carmine (E 132)
Slovenian: Črnilo: šelak propilenglikol indigotin (E132)
English: Renal impairment:
Slovenian: Ledvična okvara:
English: In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8 % of 2,557 Evista treated patients and 11.1 % of 2,576 placebo treated patients.
Slovenian: V populaciji, pri kateri so raloksifen uporabljali za zdravljenje, so zdravljenje zaradi kateregakoli od kliničnih neželenih dogodkov prekinili pri 12,8 % od 2557 bolnic, zdravljenih z zdravilom Evista, in pri 11,1 % od 2576 bolnic, ki so prejemale placebo.
English: In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7 % of 581 Evista treated patients and 11.1 % of 584 placebo-treated patients.
Slovenian: V populaciji, pri kateri so raloksifen uporabljali za preventivo, so zdravljenje zaradi kateregakoli od neželenih učinkov prekinili pri 10,7 % od 581 bolnic, zdravljenih z zdravilom Evista, in pri 11,1 % od 584 bolnic, ki so prejemale placebo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/073/001 14 film coated tablets EU/1/98/073/002 28 film coated tablets EU/1/98/073/003 84 film coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/98/073/001 14 filmsko obloženih tablet
English: Evista is used to treat and prevent osteoporosis in postmenopausal women.
Slovenian: Zdravilo Evista se uporablja za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.
English: Over the 4 years of the osteoporosis treatment trial (involving 7,705 patients), Evista 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).
Slovenian: V več kot 4 letih preskušanja zdravljenja osteoporoze, ki je vključevalo 7.705 bolnic, je zdravljenje z zdravilom Evista 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 0,130,58) ter tveganje za invazivni rak dojke, pozitiven za estrogenske receptorje (ER), za 79 % (RR 0,21 pri 95 % CI 0,07-0,50).
English: 6.3 Shelf-life 3 years.
Slovenian: 6.3 Rok uporabnosti
English: Reproductive system and breast disorders Common: Mild breast symptoms a such as pain, enlargement and tenderness General disorders and administration site conditions Very common: Flu syndrome
Slovenian: Pogosti: blagi simptomi v dojkaha, kot so bolečina, povečanje in občutljivost za dotik Splošne težave in spremembe na mestu aplikacije Zelo pogosti: sindrom gripe
English: Evista 60 mg film coated tablets raloxifene hydrochloride
Slovenian: EVISTA 60 mg filmsko obložene tablete raloksifenijev klorid
English: Evista contains lactose.
Slovenian: Zdravilo Evista vsebuje laktozo.
English: In a study comparing Evista with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Slovenian: iv) Histomorfometrija (kakovost kosti): V raziskavi, v kateri so zdravilo Evista 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.
English: What Evista contains - The active substance is raloxifene hydrochloride.
Slovenian: Kaj vsebuje zdravilo Evista - Učinkovina je raloksifenijev klorid.
English: In patients with moderate and mild renal impairment, Evista should be used with caution.
Slovenian: Zdravilo Evista moramo uporabljati previdno pri bolnikih z zmerno in blago ledvično okvaro.
English: In a study of 7,705 postmenopausal women with a mean age of 66 years and with osteoporosis or osteoporosis with an existing fracture, Evista treatment for 3 years reduced the incidence of vertebral fractures by 47 % (RR 0.53, CI 0.35, 0.79; p < 0.001) and 31 % (RR 0.69, CI 0.56, 0.86; p < 0.001) respectively.
Slovenian: i) Incidenca zlomov: V raziskavi pri 7.705 ženskah po menopavzi s srednjo starostjo 66 let in z osteoporozo je 3-letno zdravljenje z zdravilom Evista 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 obstoječim zlomom pa je bila incidenca zlomov vretenc zmanjšana za 31 % (RR 0,69 pri 95 % CI 0,56-0,86; p < 0,001).
English: Evista contains the active substance raloxifene hydrochloride.
Slovenian: Zdravilo Evista vsebuje učinkovino raloksifenijev klorid.
English: Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
Slovenian: Jedro tablete: povidon polisorbat 80 brezvodna laktoza laktoza monohidrat krospovidon magnezijev stearat
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Evista in vsebina pakiranja
English: Evista 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.
Slovenian: Štiriletno zdravljenje z zdravilom Evista 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 obstoječim zlomom pa je incidenca zmanjšana za 32 % (RR 0,68 pri 95 % CI 0,56-0,83).