natgillin/translations-raw huggingface dataset:
In vitro, raloxifene did not interact with the binding of warfarin, phenytoin, or tamoxifen. 
Raloksifen ni vplival na vezavo varfarina, fenitoina ali tamoksifena in vitro.
Always take this medicine exactly as your doctor has told you. 
Pomembno je, da nadaljujete z jemanjem zdravila Optruma toliko časa kot vam je predpisal vaš zdravnik.
In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7 % of 581 Optruma treated patients and 11.1 % of 584 placebo-treated patients. 
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 Optruma, in pri 11,1 % od 584 bolnic, ki so prejemale placebo.
• Headache including migraine 
• Glavobol vključno z migreno • Krči v nogah
In the 4th year alone, Optruma reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88). 
Samo v četrtem letu zdravljenja je prejemanje zdravila Optruma znižalo tveganje za nov zlom vretenca za 39 % (RR 0,61 pri 95 % CI 0,43-0,88).
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. 
Raziskave so pokazale značilno zmanjšanje incidence zlomov vretenc, ne pa tudi kolka.
• Increased risk of blood clots in the eyes (retinal vein thrombosis) 
• Povečano tveganje krvnih strdkov v očeh (tromboza retinalnih ven)
Raloxifene has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Raloksifen nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
b. Tabulated summary of adverse reactions 
b) Tabelarični pregled neželenih učinkov
Therefore Optruma is not recommended to be used in patients with hepatic insufficiency. 
Optruma ne priporočamo pri bolnicah z jetrno insuficienco.
Hepatic impairment: Optruma should not be used in patients with hepatic impairment (see section 4.3 and 4.4). 
Zdravila Optruma ne smemo uporabljati pri bolnikih z jetrno okvaro (glejte poglavje 4.3 in 4.4).
Blister boxes contain 14, 28, or 84 tablets. 
14, 28 ali 84 tablet.
• Increased risk of blood clots in the legs (deep vein thrombosis) 
• Povečano tveganje krvnih strdkov v nogah (globoka venska tromboza)
Raloxifene is distributed extensively in the body. 
Raloksifen se v veliki meri porazdeli po telesu.
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). 
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
No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified. 
V teh raziskavah niso ugotovili nobenih klinično pomembnih učinkov sočasne uporabe naštetih zdravil na plazemske koncentracije raloksifena.
Contents of the pack and other information 
Shranjevanje zdravila Optruma Vsebina pakiranja in dodatne informacije
Another adverse reaction observed was leg cramps (5.5 % for Optruma, 1.9 % for placebo in the prevention population and 9.2 % for Optruma, 6.0 % for placebo in the treatment population). 
Naslednji opaženi neželeni učinek so bili krči v nogah (5,5 % pri zdravilu Optruma in 1,9 % pri placebu v skupini, v kateri so raloksifen uporabljali za preventivo, ter 9,2 % pri zdravilu Optruma in 6,0 % pri placebu v skupini, v kateri so raloksifen uporabljali za zdravljenje).
Renal impairment: 
Jetrna okvara:
Must not be used in women with child bearing potential (see section 4.6). 
Zdravilo se ne sme uporabljati pri ženskah v rodni dobi (glejte poglavje 4.6).
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset 
• Gastrointestinalni simptomi kot so siljenje na bruhanje, bruhanje, bolečina v trebuhu in razdražen želodec
What Optruma looks like and contents of the pack 
Izgled zdravila Optruma in vsebina pakiranja
Optruma is indicated for the treatment and prevention of osteoporosis in postmenopausal women. 
Zdravilo Optruma je indicirano za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.
Unexplained uterine bleeding. 
Nerazložljiva krvavitev iz maternice.
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 bile 4 leta zdravljene z raloksifenom, so poročali o benignih polipih endometrija v 0,9 % primerov v primerjavi z
Presystemic glucuronidation is extensive. 
Raloksifen je podvržen obsežni predsistemski glukuronidaciji.
In the RUTH study, leg cramps were observed in 12.1 % of raloxifene-treated patients and 8.3 % of placebo-treated patients. 
V študiji RUTH so opažali krče v nogah pri 12,1 % bolnic zdravljenih z raloksifenom in 8,3 % bolnic, ki so jemale placebo.
If you wish you may take a glass of water with it. Do not break or crush the tablet before taking it. A broken or crushed tablet may taste bad and there is a possibility that you will receive an incorrect dose. 
Prelomljena ali zdrobljena tableta je lahko neprijetnega okusa in obstaja možnost, da ne boste prejeli pravega odmerka.
Common side effects (affects 1 to 10 users in 100) are: 
Pogosti neželeni učinki (prizadanejo 1 do 10 bolnic od 100 bolnic) so:
Optruma is used to treat and prevent osteoporosis in postmenopausal women. 
Zdravilo Optruma se uporablja za zdravljenje in preprečevanje osteoporoze pri ženskah po menopavzi.
Over the 4 years of the osteoporosis treatment trial (involving 7,705 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 več kot 4 letih preskušanja zdravljenja osteoporoze, ki je vključevalo 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 0,130,58) ter tveganje za invazivni rak dojke, pozitiven za estrogenske receptorje (ER), za 79 % (RR 0,21 pri 95 % CI 0,07-0,50).
Special populations 
Posebne skupine bolnic
Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy. 
Tveganje je primerljivo z ugotovljenim tveganjem, povezanim z uporabo trenutno predpisovane hormonske nadomestne terapije.
In one of these trials the women had previously undergone hysterectomy. 
V enem od teh preskušanj so imele ženske pred zdravljenjem tudi opravljeno kirurško odstranitev maternice.
Raloxifene is absorbed rapidly after oral administration. 
Po peroralni uporabi se raloksifen absorbira hitro.
If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines. 
Če jemljete zdravila za srce, ki vsebujejo digitalis, ali antikoagulante za redčenje krvi, kakor je npr.
• Mild breast symptoms such as pain, enlargement and tenderness 
• Blagi simptomi dojk kot so bolečina, povečanje in občutljivost
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 povzročil motnje ovarijskega ciklusa med zdravljenjem, ne pa zakasnitve plodnega parjenja po prenehanju zdravljenja.
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. 
iv) Histomorfometrija (kakovost kosti): 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.
Generally calcium and vitamin D supplements are advised in women with a low dietary intake. 
Ženskam, ki s hrano vnašajo majhne količine kalcija in vitamina D, na splošno svetujemo, naj jemljejo dodatke kalcija in vitamina D. Starejši:
Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin 
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.
<2D barcode carrying the unique identifier included.> 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
• Gallstones 
• Žolčni kamni
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. 
Med povprečnim spremljanjem 5,6 let je 59 (1,2 %) žensk, ki so se zdravile z raloksifenom in 39
Its clinical use, therefore, cannot be recommended in breastfeeding women. 
Tveganja za novorojenčke/dojenčke ni mogoče izključiti, zato njegove klinične uporabe pri doječih materah ne priporočamo.
In patients with moderate and mild renal impairment, Optruma should be used with caution. 
Zdravilo Optruma moramo uporabljati previdno pri bolnikih z zmerno in blago ledvično okvaro.
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. 
Aktivni venski tromboembolični zapleti ali venski tromboembolični zapleti v anamnezi, vključno s trombozo globokih ven, pljučno embolijo in trombozo retinalnih ven.
- The active substance is raloxifene hydrochloride. 
- Zdravilna učinkovina je raloksifenijev klorid.
However, there was an increase in death due to stroke in women assigned to raloxifene. 
Vendar je bilo pri ženskah, ki so dobivale raloksifen, več smrti zaradi kapi.
Optruma contains the active substance raloxifene hydrochloride. 
Zdravilo Optruma vsebuje zdravilno učinkovino raloksifenijev klorid.
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride 
Optruma 60 mg filmsko obložene tablete raloksifenijev klorid
Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia. 
V primerjavi s placebom uporaba raloksifena ni pokazala povezave s krvavim izcedkom,
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 povečanje pogostnosti pojava tumorjev ovarija, ki so izvirali iz granulozne ali tekalne plasti celic ovarijskih foliklov.
In a study of 7,705 postmenopausal women with a mean age of 66 years and with osteoporosis or osteoporosis with an existing fracture, Optruma 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. 
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 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 obstoječim zlomom pa je bila incidenca zlomov vretenc zmanjšana za 31 % (RR 0,69 pri 95 % CI 0,56-0,86; p < 0,001).
However, modest decreases in the prothrombin time have been observed, and if raloxifene is given concurrently with warfarin or other coumarin derivatives, the prothrombin time should be monitored. 
Če bolnico zdravimo sočasno z raloksifenom in varfarinom ali drugimi kumarinskimi derivati, je torej treba spremljati protrombinski čas.
EU/1/98/074/001 14 film coated tablets EU/1/98/074/002 28 film coated tablets EU/1/98/074/003 84 film coated tablets 
EU/1/98/074/002 28 filmsko obloženih tablet
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER BOX FILM COATED TABLETS: 
ŠKATLA S PRETISNIM OMOTOM S FILMSKO OBLOŽENIMI TABLETAMI:
Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene. 
Vsaka tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg raloksifena.
Optruma mimics some of the helpful effects of oestrogen after the menopause. 
Po menopavzi zdravilo Optruma posnema nekatere koristne učinke estrogena.
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion. 
Pri odraslih bolnikih, ki so vzeli več kot 120 mg raloksifena naenkrat, so poročali o simptomih krčev in omotice.
Optruma 60 mg film coated tablets 
IME ZDRAVILA Optruma 60 mg filmsko obložene tablete
• If you are being treated or have been treated for blood clots in the legs (deep vein thrombosis), 
• Če vas trenutno zdravijo zaradi krvnih strdkov ali so vas v preteklosti zdravili zaradi krvnih strdkov v nogah (tromboza globokih ven), v pljučih (pljučna embolija) ali v očeh (tromboza retinalnih ven).
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. 
1.000 bolnških let v skupini raloksifena in 1,4 % ali 2,70 primerih na 1.000 bolnških let v skupini placeba.
The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals. 
Bolnica jo lahko vzame ob kateremkoli času dneva, ne glede na obroke.
In the osteoporosis treatment study, significantly fewer Optruma-treated patients required initiation of hypolipidaemic therapy compared to placebo. 
uvedba hipolipemične terapije potrebna pri značilno manjšem številu v primerjavi s placebom.
Very common: Gastrointestinal symptoms a such as nausea, vomiting, abdominal pain, dyspepsia 
Zelo pogosti: gastrointestinalni simptomia, kot so navzea, bruhanje, bolečine v trebuhu,
Optruma and oestrogen affect bone remodelling and calcium metabolism similarly. 
iii) Kinetika kalcija: Zdravilo Optruma in estrogen imata podoben vpliv na prestrukturiranje kostnega tkiva in presnovo kalcija.
A similar frequency of increases was noted among placebo patients. 
Podobno pogostnost zvišanja so opazili tudi pri bolnicah,
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 obstoječim zlomom pa je incidenca zmanjšana za 32 % (RR 0,68 pri 95 % CI 0,56
Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo. 
Pri ženskah, zdravljenih z raloksifenom, ves čas ni bilo razlike v debelini endometrija v primerjavi z debelino endometrija pri tistih, ki so prejemale placebo.
Uncommon: Fatal strokes 
Občasni: smrtne kapi Žilne bolezni
Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5 times the controls. 
Ko so bolnicam s cirozo in blago jetrno okvaro (razred A po Child-Pughu) dali en odmerek raloksifena, so izmerili plazemske koncentracije raloksifena, ki so bile približno 2,5-krat višje od tistih, ki so jih ugotovili pri preiskovankah iz kontrolne skupine.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause. 
Osteoporoza je bolezen, zaradi katere se zmanjša gostota kosti in te postanejo krhke.
It is important that you continue taking Optruma for as long as your doctor prescribes the medicine, Optruma can treat or prevent your osteoporosis only if you continue to take the tablets. 
Zdravilo Optruma lahko zdravi in preprečuje osteoporozo samo, če nadaljujete z jemanjem tablet.
Superficial vein thrombophlebitis occurred in a frequency of less than 1 %. 
Tromboflebitis povrhnjih ven se je pojavljal s pogostnostjo, manjšo od
No cases of raloxifene overdose were reported during clinical trials. 
Med temi kliničnimi študijami niso poročali o prevelikem odmerjanju raloksifena.
Common: Headache, including migraine a 
Bolezni živčevja Pogosti: glavobol, vključno z migrenoa
Optruma is only for use in postmenopausal women. 
Zdravilo Optruma je namenjeno le za zdravljenje žensk po menopavzi.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in Optruma treated patients compared to placebo. 
Pri bolnicah, zdravljenih z zdravilom Optruma, je bilo v primerjavi s tistimi, ki so prejemale placebo, ugotovljeno relativno tveganje 1,60 (CI 0,95, 2,71).
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
Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebocontrolled clinical trials of raloxifene in osteoporosis. 
Med zdravljenjem z raloksifenom v s placebom nadzorovanih kliničnih študijah raloksifena pri osteoporozi so opažali tudi rahlo znižanje (6-10 %) števila trombocitov.
14 film coated tablets 28 film coated tablets 84 film coated tablets 
84 filmsko obloženih tablet
In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8 % of 2,557 Optruma treated patients and 11.1 % of 2,576 placebo treated patients. 
od 2557 bolnic, zdravljenih z zdravilom Optruma, in pri 11,1 % od 2576 bolnic, ki so prejemale placebo.
Co-administration of raloxifene and warfarin does not alter the pharmacokinetics of either compound. 
Sočasna uporaba raloksifena in varfarina ne spremeni farmakokinetike nobene od teh snovi, opaženo pa je bilo zmerno skrajšanje protrombinskega časa.
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene 
Vsaka filmsko obložena tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg raloksifena.
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base. 
Ena filmsko obložena tableta vsebuje 60 mg raloksifenijevega klorida, kar ustreza 56 mg proste baze raloksifena.
In clinical trials, Optruma did not stimulate the postmenopausal uterine endometrium. 
c) Vplivi na endometrij in medenično dno V kliničnih preskušanjih zdravilo Optruma ni stimuliralo postmenopavzalnega materničnega endometrija.
Common: Mild breast symptoms a such as pain, enlargement and tenderness 
Pogosti: blagi simptomi v dojkaha, kot so bolečina, povečanje in občutljivost za dotik
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 povečana incidenca ovarijskih tumorjev pri tistih živalih, ki so prejele 9 do 242 mg/kg (0,3- do 32-kratne AUC za človeka),
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.
Peak concentrations of raloxifene are reduced with co-administration with ampicillin. 
Sočasno jemanje ampicilina zmanjša najvišje koncentracije raloksifena.
Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed. 
Med zdravljenjem je treba skrbno spremljati vrednosti serumskih koncentracij celokupnega bilirubina, gama-glutamil transferaze,
Talk to your doctor or pharmacist before you take Optruma. 
Pred začetkom jemanja zdravila Optruma se posvetujte s svojim zdravnikom ali s farmacevtom.
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. 
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
100 film coated tablets 
28 filmsko obloženih tablet
Optruma 
dispepsija
Optruma contains lactose 
Škatle s pretisnimi omoti vsebujejo po
Optruma must not be taken by women of child bearing potential. 
Zdravila Optruma ne smejo jemati ženske v rodni dobi.
So any vaginal bleeding while you take Optruma is unexpected. 
Malo verjetno je, da bi zdravilo Optruma povzročilo krvavitev iz nožnice, zato je vsaka krvavitev iz nožnice v času jemanja zdravila Optruma nepričakovana in morate prositi svojega zdravnika, naj vas pregleda.
Anhydrous lactose Lactose monohydrate Crospovidone 
Jedro tablete: povidon polisorbat 80 brezvodna laktoza laktoza monohidrat krospovidon magnezijev stearat
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 ledvične ciste (≥
The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 - 1.95). 
HR = 1,44, (1,66 - 1,95).
Titanium dioxide (E 171) Polysorbate 80 
Filmska obloga tablete: titanov dioksid (E171) polisorbat 80 hipromeloza makrogol 400 karnauba vosek
Film coated tablet. 
FARMACEVTSKA OBLIKA Filmsko obložena tableta
Gastrointestinal disorders 
Občasni: trombocitopenijaa
How to store Optruma 
Shranjevanje zdravila Optruma
Magnesium stearate 
Stopnje holecistomije za raloksifen
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS): 
PRETISNI OMOT (VSE VELIKOSTI PAKIRANJ PRETISNIH OMOTOV):
Optruma reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. 
Pri ženskah s postmenopavzalno osteoporozo zdravilo Optruma zmanjša tveganje za zlome vretenc.
Raloxifene was not genotoxic in any of the extensive battery of test systems applied. 
Z nobenim od velikega števila uporabljenih testnih sistemov niso ugotavljali genotoksičnih učinkov raloksifena.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJ ZA PROMET Datum pridobitve dovoljenja za promet: 5. avgust 1998
OTHER 
V
The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology. 
Pri bolnicah, pri katerih obstaja tveganje za pojav venskih tromboemboličnih zapletov kakršnekoli etiologije, je treba upoštevati razmerje med koristnostjo jemanja zdravila in tveganjem, ki ga jemanje zdravila povzroča.
Tablet coating: 
Bolezni prebavil
Propylene glycol Indigo carmine (E 132) 
šelak propilenglikol indigotin (E132) 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.
BATCH NUMBER 
PRILOGA I
Tell your doctor or pharmacist. 
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
EU/1/98/074/004 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/98/074/004