FrancophonIA/ELRC3.0 huggingface dataset:
English: Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8 % or 3.22 cases per 1,000 patient years.
Croatian: Tijekom svih placebo kontroliranih kliničkih ispitivanja raloksifena u osteoporozi pojava venskih tromboembolijskih događaja, uključujući duboku vensku trombozu, plućnu emboliju i trombozu vene retine, očitovala se s učestalošću od približno 0,8 % ili 3,22 slučaja na 1000 bolesnika-godina.
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).
Croatian: raloksifen nije utjecao na incidenciju infarkta miokarda, hospitalizaciju zbog akutnog koronarnog sindroma, moždani udar ili ukupnu smrtnost, uključujući ukupnu srčano-krvožilnu smrtnost, u usporedbi s placebom (za porast rizika od moždanog udara sa smrtnim ishodom vidjeti dio 4.4).
English: Common: Headache, including migraine a
Croatian: Poremećaji živčanog sustava Često: glavobolja, uključujući migrenu a
English: Uncommon: Fatal strokes
Croatian: Manje često: fatalni moždani udari
English: Optruma should not be used in patients with severe renal impairment (see section 4.3).
Croatian: Optrumu ne smiju uzimati bolesnice s teškim oštećenjem bubrega (vidjeti dio 4.3).
English: Peak concentrations of raloxifene are reduced with co-administration with ampicillin.
Croatian: Vršne koncentracije raloksifena smanjene su tijekom istodobne primjene ampicilina.
English: Optruma is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Croatian: Optruma je indicirana u liječenju i prevenciji osteoporoze u žena u postmenopauzi.
English: Tablet Core: Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate.
Croatian: Jezgra tablete: povidon, polisorbat 80, bezvodna laktoza, laktoza hidrat, krospovidon, magnezijev stearat.
English: In the 4th year alone, Optruma reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Croatian: Optruma je smanjila rizik novonastalog prijeloma kralješka za 39 % (RR 0,61; CI 0,43; 0,88).
English: There were no differences between the raloxifene and placebo groups with respect to the incidence of reported uterine bleeding.
Croatian: Nije postojala razlika između raloksifenske i placebo skupine u pogledu incidencije krvarenja iz maternice.
English: Very common: Vasodilation (hot flushes) Uncommon: Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis, Arterial thromboembolic reactions a
Croatian: Vrlo često: vazodilatacija (navale crvenila uz osjećaj vrućine) Manje često: venski tromboembolijski događaji, uključujući duboku vensku trombozu, plućnu emboliju, trombozu vene retine, tromboflebitis površinskih vena arterijske tromboembolijske reakcije a
English: Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Croatian: Aktivni ili venski tromboembolijski događaji (VTE) u anamnezi, uključujući duboku vensku trombozu, plućnu emboliju i trombozu vene retine.
English: Hepatic impairment: Optruma should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Croatian: Optrumu ne smiju uzimati bolesnice s oštećenjem jetre (vidjeti dio 4.3 i 4.4).
English: 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.
Croatian: Liječenje Optrumom tijekom 4 godine smanjilo je incidenciju prijeloma kralježaka za 46 % (RR 0,54; CI 0,38; 0,75), odnosno 32 % (RR 0,68; CI 0,56; 0,83) u bolesnica s osteoporozom, odnosno osteoporozom s postojećim prijelomom.
English: Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (>5.6 mmol/l), raloxifene may be associated with a marked increase in serum triglycerides.
Croatian: Ograničeni klinički podaci sugeriraju da primjena raloksifena može biti povezana sa značajnim porastom serumskih triglicerida u bolesnica koje su imale hipertrigliceridemiju (> 5,6 mmol/l)
English: Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin
Croatian: Raloksifen umjereno povisuje koncentraciju globulina za koje se vežu hormoni, uključujući globuline za koje se vežu steroidni spolni hormoni (SHBG), globuline za koje se veže tiroksin (TBG) te globuline za koje se vežu kortikosteroidi (CBG), koje prati povišenje ukupnih koncentracija hormona.
English: Optruma is used to treat and prevent osteoporosis in postmenopausal women.
Croatian: Optruma se primjenjuje u liječenju i prevenciji osteoporoze u žena u postmenopauzi.
English: These results may have been confounded by baseline differences in BMD and vertebral fractures.
Croatian: Ti rezultati mogu biti iskrivljeni (confounded) zbog razlike u početnom BMD-u i broju prijeloma kralježaka između dvije skupine.
English: In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3 % of patients treated with raloxifene and 2.6 % of patients treated with placebo.
Croatian: U ispitivanju (RUTH) žena u postmenopauzi s dokazanom koronarnom bolešću srca ili s povećanim rizikom od koronarnih događaja pojavila se dodatna nuspojava, kolelitijaza, u 3,3 % bolesnica koje su liječene raloksifenom i 2,6 % bolesnica koje su uzimale placebo.
English: • Hot flushes (vasodilatation)
Croatian: • navale crvenila uz osjećaj vrućine (vazodilatacija)
English: Superficial vein thrombophlebitis occurred in a frequency of less than 1 %.
Croatian: Tromboflebitis površinskih vena javljao se s učestalošću manjom od 1 %.
English: • Headache including migraine
Croatian: • glavobolja uključujući migrenu • grčevi u nogama
English: 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.
Croatian: Nakon pojedinačne doze raloksifena primijenjene u bolesnika s cirozom jetre i blagim oštećenjem jetre (stadij A prema Child-Pughu) nastale koncentracije raloksifena u plazmi bile su približno 2,5 puta više od kontrolnih.
English: For oral use Read the package leaflet before use.
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: Uncommon side effects (affects 1 to 10 users in 1000) are:
Croatian: Manje česte nuspojave (javljaju se u 1 do 10 na 1000 korisnika):
English: 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.
Croatian: Relativni rizik od venskih tromboembolijskih događaja tijekom liječenja raloksifenom iznosio je 1,60 (CI 0,95; 2,71) uspoređujući s placebom te 1,0 (CI 0,3; 6,2) uspoređujući s estrogenskom ili hormonskom nadomjesnom terapijom.
English: In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8 % in the raloxifene-treated patients and 4.7 % in the placebo-treated patients.
Croatian: U ispitivanju RUTH u koje je bilo uključeno 10 101 žena u postmenopauzi s dokazanom koronarnom bolesti srca ili s povećanim rizikom za koronarne događaje, pojava vazodilatacije (navala crvenila uz osjećaj vrućine) uočena je u 7,8 % bolesnica koje su liječene raloksifenom i 4,7 % bolesnica koje su liječene placebom.
English: 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.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Primjena raloksifena povezana je s povećanim rizikom od razvoja venskih tromboembolijskih događaja koji je sličan onom prijavljenom riziku pri primjeni hormonske nadomjesne terapije.
English: • Increased risk of blood clots in the legs (deep vein thrombosis)
Croatian: • povećan rizik od krvnih ugrušaka u nogama (duboka venska tromboza)
English: 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).
Croatian: Grčevi u nogama još su jedna uočena nuspojava (5,5 % kod Optrume i 1,9 % kod placeba u skupini koja je uzimala raloksifen za prevenciju te 9,2 % kod Optrume i 6,0 % kod placeba u skupini koja je uzimala raloksifen za liječenje).
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, 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.
Croatian: U ispitivanju provedenom na 7705 žena u postmenopauzi srednje dobi od 66 godina s osteoporozom ili osteoporozom s postojećim prijelomom, 3-godišnje liječenje Optrumom smanjilo je incidenciju prijeloma kralježaka za 47 % (RR 0,53; CI 0,35; 0,79; p < 0,001) odnosno za
English: Optruma does not treat postmenopausal symptoms, such as hot flushes.
Croatian: Optruma ne služi za liječenje simptoma postmenopauze, poput navala crvenila uz osjećaj vrućine.
English: 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.
Croatian: Ako zbog srca uzimate lijekove koji sadrže digitalis ili antikoagulanse poput varfarina za razrjeđivanje
English: So any vaginal bleeding while you take Optruma is unexpected.
Croatian: Stoga se ne očekuje krvarenje iz rodnice dok uzimate Optrumu.
English: This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1 % for Optruma and 1.9 % for placebo; and in the treatment population occurred at an incidence of 7.1 % for Optruma and 6.1 % for placebo.
Croatian: To je bio periferni edem koji se javio s incidencijom od 3,1 % za Optrumu i 1,9 % za placebo u skupini koja je uzimala raloksifen za prevenciju; te koji se javio s incidencijom od 7,1 % za Optrumu i 6,1 % za placebo u skupini koja je uzimala raloksifen za liječenje.
English: No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
Croatian: Nisu ustanovljeni klinički značajni učinci istodobne primjene tih lijekova na koncentraciju raloksifena u plazmi.
English: 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.
Croatian: implantacija embrija kasni i poremećena je s posljedičnim produženjem gestacije i smanjenjem broja mladunčadi, ali nema utjecaja na njihov razvoj do trenutka samostalnog hranjenja.
English: България ТП "Ели Лили Недерланд" Б.В.
Croatian: ТП "Ели Лили Недерланд" Б.В. - България тел.
English: B. PACKAGE LEAFLET
Croatian: b. Tablični sažetak nuspojava
English: OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
Croatian: OPTRUMA 60 mg filmom obložene tablete raloksifenklorid
English: Very common: Gastrointestinal symptoms a such as nausea, vomiting, abdominal pain, dyspepsia
Croatian: Vrlo često: gastrointestinalni simptomi a kao što su mučnima, povraćanje, bol u abdomenu, dispepsija
English: In children, symptoms of accidental overdose included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
Croatian: Simptomi slučajnog predoziranja u djece uključivali su ataksiju, omaglicu, povraćanje, osip, proljev,
English: 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.
Croatian: U skupini od 581 bolesnice koje su uzimale Optrumu u svrhu prevencije, liječenje je prekinuto zbog bilo koje nuspojave u 10,7 %, a u skupini od 584 bolesnica koje su uzimale placebo u 11,1 % slučajeva.
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).
Croatian: Incidencija smrtnosti od moždanog udara bila je 2,2 od 1000 žena godišnje u skupini koja je primala raloksifen prema 1,5 od 1000 žena godišnje u placebo skupini (vidjeti dio 4.4).
English: • Increased risk of blood clots in the eyes (retinal vein thrombosis)
Croatian: • povećan rizik od krvnih ugrušaka u očima (tromboza vene retine)
English: In the RUTH study, leg cramps were observed in 12.1 % of raloxifene-treated patients and 8.3 % of placebo-treated patients.
Croatian: U ispitivanju RUTH uočena je pojava grčeva u nogama u 12,1 % bolesnica koje su liječene raloksifenom i 8,3 % bolesnica koje su dobivale placebo.
English: Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Istodobna primjena antacida koji sadrže kalcijev karbonat ili aluminijev i magnezijev hidroksid ne utječe na sistemsku izloženost raloksifenu.
English: In clinical trials, Optruma did not stimulate the postmenopausal uterine endometrium.
Croatian: Optruma nije stimulirala endometrij maternice u postmenopauzi.
English: Lot {number}
Croatian: BROJ SERIJE Lot {broj}
English: Superficial vein thrombophlebitis occurred in a frequency of 1 % in the raloxifene group and 0.6 % in the placebo group.
Croatian: Tromboflebitis površinskih vena javio se s učestalosti od 1 % u skupini liječenoj raloksifenom i 0,6 % u skupini koja je dobivala placebo.
English: A relative risk of 1.60 (CI 0.95, 2.71) was observed in Optruma treated patients compared to placebo.
Croatian: Relativni rizik u bolesnica liječenih Optrumom bio je 1,60 (CI 0,95 - 2,71), uspoređujući sa skupinom na placebu.
English: Optruma 60 mg film coated tablets
Croatian: NAZIV LIJEKA Optruma 60 mg filmom obložene tablete
English: This must be investigated by your doctor.
Croatian: U tom slučaju morate se javiti svom liječniku radi pregleda.
English: Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 60 mg raloksifenklorida, što odgovara 56 mg slobodne baze raloksifena.
English: Optruma must not be taken by women of child bearing potential.
Croatian: Optrumu ne smiju uzimati žene generativne dobi.
English: Optruma contains the active substance raloxifene hydrochloride.
Croatian: Što Optruma sadrži - Djelatna tvar je raloksifenklorid.
English: In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/kg).
Croatian: U štakora su se pojavili zastoj razvoja ploda, valovita rebra te bubrežne ciste (≥ 1 mg/kg).
English: Polysorbate 80
Croatian: Papendorpseweg 83
English: • Mild breast symptoms such as pain, enlargement and tenderness
Croatian: • blagi simptomi dojki kao što su bol, povećanje i osjetljivost
English: • If you are being treated or have been treated for blood clots in the legs (deep vein thrombosis),
Croatian: • Ako se liječite ili ste bili liječeni zbog krvnih ugrušaka u nogama (duboka venska tromboza), u plućima (plućna embolija) ili u očima (tromboza vene retine).
English: 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.
Croatian: uočena su umjerena smanjenja protrombinskog vremena što iziskuje praćenje tog vremena kod istodobne primjene raloksifena s varfarinom ili derivatima kumarina.
English: The following convention has been used for the classification of the adverse reactions: very common
Croatian: Unutar svake grupe učestalost nuspojave klasificirana je na sljedeći način: vrlo često (≥ 1/10), često
English: 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).
Croatian: Optrumom u usporedbi s placebom smanjilo je rizik od ukupnog karcinoma dojke za 62 % (RR 0,38; CI 0,21; 0,69), rizik od invazivnog karcinoma dojke za 71 % (RR 0,29; CI 0,13; 0,58), i rizik od invazivnog karcinoma dojke pozitivnog na estrogenski receptor (ER) za 79 % (RR 0,21; CI 0,07;
English: Eli Lilly Slovakia s.r.o.
Croatian: Slovenská republika Eli Lilly Slovakia s.r.o.
English: Very common: Flu syndrome Common: Peripheral oedema
Croatian: Često: periferni edemi
English: 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
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/074/001 14 filmom obloženih tableta
English: • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
Croatian: • probavni simptomi poput mučnine, povraćanja, bolova u trbuhu i nadražaja želuca
English: 100 film coated tablets
Croatian: OBLIK I SADRŽAJ 100 filmom obloženih tableta
English: In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Croatian: U odraslih bolesnica koje su uzele više od 120 mg u jednokratnoj dozi prijavljeni su simptomi grčeva u nogama i omaglice.
English: Titanium dioxide (E 171) Polysorbate 80
Croatian: Ovojnica tablete: titanijev dioksid (E 171) polisorbat 80 hipromeloza makrogol 400 karnauba vosak
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.
Croatian: (koja uključuju ukupno 15 234 bolesnice, 7601 koje su uzimale raloksifen od 60 mg i 7633 koje su uzimale placebo) u žena u postmenopauzi s osteoporozom, ili dokazanom koronarnom bolesti srca
English: Uncommon: Thrombocytopenia a
Croatian: Manje često: trombocitopenija a
English: • Gallstones
Croatian: • žučni kamenci
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Optruma
English: In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.
Croatian: U ispitivanju žena u postmenopauzi s dokazanom koronarnom bolesti srca ili povećanim rizikom od koronarnih događaja, raloksifen u usporedbi s placebom nije utjecao na incidenciju infarkta miokarda,
English: As safety information regarding co-administration of raloxifene with systemic oestrogens is limited, such use is not recommended.
Croatian: Ne preporučuje se istodobno uzimanje raloksifena i sistemskih estrogena jer su podaci o sigurnosti takve primjene ograničeni.
English: Compared to placebo there was no increased use in Optruma treated patients.
Croatian: Optrumom nije bilo njihove značajno veće primjene u usporedbi s bolesnicama na placebu.
English: Common: Mild breast symptoms a such as pain, enlargement and tenderness
Croatian: Često:blagi simptomi dojki a kao što su bol, povećanje i osjetljivost
English: How to store Optruma
Croatian: Kako čuvati Optrumu
English: Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
Croatian: U skupini žena koje su liječene raloksifenom debljina endometrija nije se razlikovala od skupine žena koje su uzimale placebo.
English: Common side effects (affects 1 to 10 users in 100) are:
Croatian: • povišen krvni tlak Česte nuspojave (javljaju se u 1 do 10 na 100 korisnika):
English: The influence of concomitant medication on raloxifene plasma concentrations was evaluated in the prevention and treatment trials.
Croatian: U ispitivanjima prevencije i liječenja proučen je utjecaj istodobno primijenjenih lijekova na koncentracije raloksifena u plazmi.
English: Due to the nature of this disease process, Optruma is intended for long term use.
Croatian: Optruma je namijenjena za dugotrajnu primjenu.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Uputa o lijeku: Informacije za korisnika Optruma 60 mg filmom obložene tablete raloksifenklorid Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Često: osip a
English: Raloxifene has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Raloksifen ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 60 mg raloksifenklorida, što odgovara 56 mg raloksifena
English: Tablet core:
Croatian: Oštećenje jetre:
English: Laboratórios Vitória S.A. Tel: + 351- 21 4758300
Croatian: Tel: + 351- 21 4758300
English: Endometrial thickness measurements in Optruma treated women were not different from baseline after 4 years of therapy.
Croatian: Nakon 4 godine, u žena koje su liječene Optrumom, izmjerena debljina endometrija nije se razlikovala od početnih vrijednosti.
English: Povidone
Croatian: Pretrage
English: Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
Croatian: D općenito se savjetuje uzimanje nadomjestaka kalcija i vitamina D.
English: 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.
Croatian: liječenje je prekinuto zbog bilo kojeg štetnog kliničkog događaja u 12,8 %, a u skupini od 2576
English: Optruma
Croatian: Doziranje
English: Industrie Farmaceutiche Riunite s.r.l.
Croatian: Esteve Pharmaceuticals, S.A.
English: Tel: +39-055 56801
Croatian: Industrie Farmaceutiche Riunite s.r.l Tel: +39-055 56801
English: Charles de Giorgio Ltd. Tel: + 356 25600 500
Croatian: Tel: +356 25600 500
English: Eli Lilly Ges.m.b.H.
Croatian: m.b.H.
English: Fewer Optruma treated women than placebo treated women required surgical intervention for uterine prolapse.
Croatian: Manji broj kirurških zahvata zbog prolapsa maternice zabilježen je u žena liječenih Optrumom u usporedbi sa ženama koje su uzimale placebo.
English: 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).
Croatian: (279 mg/kg/dan) zabilježena je povećana incidencija tumora ovarija porijekla iz granuloznih ili teka stanica.
English: Optruma reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Croatian: U žena s postmenopauzalnom osteoporozom Optruma smanjuje rizik od prijeloma kralježaka.
English: Severe renal impairment.
Croatian: Teško oštećenje bubrega.