FrancophonIA/ELRC3.0 huggingface dataset:
English: However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking Optruma.
Croatian: Međutim, ako ste u prošlosti uzimali estrogen i pri tome imali veliki porast razine triglicerida, posavjetujte se sa svojim liječnikom prije nego počnete uzimati
English: The bottles contain 100 tablets.
Croatian: Boce sadrže 100 tableta.
English: The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Croatian: Reproduktivni i razvojni učinci proučavani kod životinja u skladu su sa znanim farmakološkim profilom raloksifena.
English: • If you have liver disease
Croatian: • Ako imate bolest jetre.
English: Replacement therapies generally reverse the excessive resorption of bone.
Croatian: Nadomjesna terapija uglavnom zaustavlja prekomjernu resorpciju kosti.
English: Clinical trials showed that a 60 mg daily dose of Optruma significantly decreased total cholesterol (3 to 6 %), and LDL cholesterol (4 to 10 %).
Croatian: Klinička ispitivanja pokazala su da dnevna primjena Optrume u dozi od 60 mg značajno snižava razinu ukupnog kolesterola (3 do 6 %) i LDL-kolesterola (4 do 10 %).
English: Raloxifene is distributed extensively in the body.
Croatian: Raloksifen se ekstenzivno distribuira u tijelu.
English: The female rodents in these studies were treated during their reproductive lives, when their ovaries were functional and highly responsive to hormonal stimulation.
Croatian: Ženke glodavaca u tim ispitivanjima tretirane su tijekom njihovog reproduktivnog života, tj. u vremenu kada su njihovi ovariji funkcionalni i snažno odgovaraju na stimulaciju hormona.
English: No fatalities associated with overdose have been reported.
Croatian: Nisu prijavljeni slučajevi smrtnog ishoda povezani s predoziranjem.
English: It does not matter what time of day you take your tablet but taking the tablet at the same time each day will help you remember to take it. You may take it with or without food.
Croatian: Nije važno u koje doba dana uzimate tabletu, međutim, uzimanje tablete svakoga dana u isto vrijeme može Vam pomoći da ne zaboravite uzeti lijek.
English: Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine, because Optruma may not work as well.
Croatian: Recite svom liječniku ako uzimate kolestiramin, koji se uglavnom koristi kao lijek za snižavanje razine masnoća, jer Optruma možda neće djelovati jednako dobro.
English: Pharmacotherapeutic group: Selective Oestrogen Receptor Modulator, ATC code: G03XC01.
Croatian: Farmakoterapijska skupina: selektivni modulator estrogenskih receptora, ATK oznaka: G03XC01.
English: Optruma is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Croatian: Optruma se primjenjuje isključivo u žena u postmenopauzi i ne smiju je uzimati žene koje još uvijek mogu zatrudnjeti.
English: After 3 years therapy Optruma decreased fibrinogen (6.71 %).
Croatian: Optruma je smanjila fibrinogen (6,71 %).
English: b) Effects on lipid metabolism and cardiovascular risk
Croatian: b) Učinci na metabolizam lipida i srčano-krvožilni rizik
English: Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
Croatian: Terapija se ne smije nastaviti prije nego što se izliječi nastalo stanje i bolesnica postane potpuno pokretljiva.
English: If you take more Optruma than you should you could have leg cramps and dizziness.
Croatian: Ako uzmete više Optrume nego što ste trebali mogu se pojaviti grčevi u nogama i omaglica.
English: Optruma does not stimulate breast tissue.
Croatian: Optruma ne stimulira tkivo dojke.
English: When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down.
Croatian: Kada žena uđe u menopauzu, opada razina ženskog spolnog hormona estrogena.
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.
Croatian: Tablica niže prikazuje nuspojave i učestalost opažene u ispitivanjima liječenja i prevencije koja su uključivala preko 13 000 žena u postmenopauzi zajedno s nuspojavama proizašlim iz posmarketinških izvješća.
English: Optruma should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
Croatian: Liječenje Optrumom treba se prekinuti u slučaju nastanka bolesti ili stanja koja dovode do dugotrajne imobilizacije.
English: The doctor may also advise you to take calcium and vitamin D supplements.
Croatian: Liječnik Vam također može preporučiti uzimanje nadomjestaka kalcija i vitamina D.
English: HDL cholesterol and triglyceride concentrations did not change significantly.
Croatian: Koncentracije HDL-kolesterola i triglicerida nisu se značajno promijenile.
English: Optruma should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
Croatian: Optrumu ne smiju uzimati bolesnice sa znacima ili simptomima raka endometrija jer sigurnost u toj skupini bolesnica nije još dovoljno ispitana.
English: 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.
Croatian: Većina doze raloksifena i glukuronidnih metabolita izlučuje se unutar 5 dana i prvenstveno se nalaze u fecesu, a manje od 6 % se izlučuje urinom.
English: If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da imate bolest nepodnošenja laktoze, jedne vrste šećera, prije nego što počnete uzimati ovaj lijek posavjetujte se sa svojim liječnikom.
English: Effects on prothrombin time may develop over several weeks if Optruma treatment is started in patients who are already on coumarin anticoagulant therapy.
Croatian: Učinci na protrombinsko vrijeme mogu se razviti tijekom nekoliko tjedana nakon što se uvede terapija Optrumom bolesnicama koje već uzimaju kumarinsku antikoagulantnu terapiju.
English: In the osteoporosis treatment trial, endometrial thickness was evaluated annually in a subset of the study population (1,644 patients) for 4 years.
Croatian: U istraživanju liječenja osteoporoze, u razdoblju od 4 godine jednom godišnje ispitana je debljina endometrija u podskupini ispitivane populacije (1644 bolesnice).
English: • Blood clot in an artery (for example stroke, including an increased risk of dying from stroke)
Croatian: • krvni ugrušak u arteriji (na primjer moždani udar, uključujući povećan rizik od smrti uslijed moždanog udara)
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3).
Croatian: Ako se lijek greškom uzme tijekom trudnoće ili tijekom uzimanja lijeka bolesnica ostane trudna, bolesnicu se mora upozoriti o mogućim opasnostima za fetus (vidjeti dio 5.3).
English: Elderly: No dose adjustment is necessary for the elderly.
Croatian: Prilagođavanje doze kod starijih nije potrebno.
English: In general, it does not change triglycerides or HDL ("good") cholesterol.
Croatian: Uglavnom ne mijenja razinu triglicerida ili HDL („dobrog“) kolesterola.
English: • Flu syndrome
Croatian: • sindrom nalik gripi
English: 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.
Croatian: Optruma je povezana sa smanjenjem resorpcije kosti i sa srednjim pozitivnim pomakom u ravnoteži kalcija od 60 mg dnevno prije svega zbog smanjenog gubitka kalcija urinom.
English: Data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/or genespecific.
Croatian: Podaci upućuju da estrogenski receptori reguliraju gensku ekspresiju na najmanje dva različita načina koja su ligandno, tkivno i/ili genski specifična.
English: Concomitant use of vaginal oestrogen preparations was allowed in the clinical trial programme, if necessary to treat atrophic vaginal symptoms.
Croatian: Istodobna primjena vaginalnih estrogenskih preparata bila je dopuštena tijekom programa kliničkih ispitivanja ako je bilo potrebno liječiti simptome vaginalne atrofije.
English: The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 - 1.95).
Croatian: Omjer hazarda za sve pojave VTE događaja u ispitivanju RUTH bio je HR = 1,44, (1,06 - 1,95).
English: Film coated tablet.
Croatian: Filmom obložena tableta.
English: Endometrial biopsies taken after six months therapy with Optruma 60 mg daily demonstrated nonproliferative endometrium in all patients.
Croatian: Biopsije endometrija uzete nakon šestomjesečne terapije Optrumom u dozi od 60 mg dnevno u svih su bolesnica pokazale neproliferativni endometrij.
English: It is unlikely that Optruma will cause vaginal bleeding.
Croatian: Nije vjerojatno da će Optruma uzrokovati krvarenje iz rodnice.
English: Optruma therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Croatian: Liječenje Optrumom u trajanju od 8 godina nije značajno utjecalo na rizik nastanka srčano-krvožilnih događaja u bolesnica uključenih u ispitivanje liječenja osteoporoze.
English: 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.
Croatian: Gubitak kosti izrazito je brz prvih 10 godina nakon menopauze, kada je kompenzatorno povećanje koštane izgradnje nedostatno u usporedbi s gubitkom zbog resorpcije.
English: There is no specific antidote for raloxifene hydrochloride.
Croatian: Ne postoji specifični antidot za raloksifenklorid.
English: If you stop taking Optruma
Croatian: Ako prestanete uzimati Optrumu
English: Optruma (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Croatian: Optruma (n = 317) je uspoređena s kontinuiranom kombiniranom hormonskom nadomjesnom terapijom (HNT) (n = 110) ili cikličkom HNT-om (n = 205) u bolesnica tijekom nekih kliničkih ispitivanja.
English: Rare cases of moderate increases in AST and/or ALT have been reported where a causal relationship to raloxifene can not be excluded.
Croatian: Zabilježeni su rijetki slučajevi umjerenog porasta razine AST i/ili ALT, gdje se ne može isključiti uzročna povezanost s raloksifenom.
English: Raloxifene is metabolised primarily in the liver.
Croatian: Raloksifen se primarno metabolizira u jetri.
English: Optruma are white, oval, film coated tablets which are marked with the number 4165.
Croatian: Optruma su bijele, ovalne, filmom obložene tablete s otisnutim brojem 4165.
English: The blister boxes contain 14, 28 or 84 tablets.
Croatian: Kutije s blisterima sadrže 14, 28 ili 84 tablete.
English: d) Effects on breast tissue
Croatian: d) Učinci na tkivo dojke
English: Any uterine bleeding during Optruma therapy is unexpected and should be fully investigated by a specialist.
Croatian: Svako krvarenje iz maternice tijekom liječenja Optrumom nije očekivano te ga specijalist mora u potpunosti ispitati.
English: Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Croatian: Sistemska izloženost (AUC) raloksifenu u toj skupini životinja bila je približno 400 puta veća od vrijednosti u žena u postmenopauzi koje su dobivale dozu od 60 mg.
English: Therefore, Optruma should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Croatian: Stoga Optrumu treba uzimati u liječenju i prevenciji osteoporoze samo nakon što je liječenje karcinoma dojke, uključujući i adjuvantnu terapiju, završeno.
English: 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.
Croatian: Od 4. do 8. godine liječenja bolesnicama je bilo dopušteno istodobno uzimanje bisfosfonata, kalcitonina i fluorida i sve bolesnice uključene u ovo ispitivanje primale su nadomjestke kalcija i vitamina D.
English: Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
Croatian: Povećavanje doza raloksifena rezultira, nešto manjim od proporcionalnog, povećanjem površine ispod krivulje koncentracije u plazmi prema vremenu (AUC).
English: <2D barcode carrying the unique identifier included.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.>
English: What you need to know before you take Optruma Do not take Optruma:
Croatian: Što morate znati prije nego počnete uzimati Optrumu
English: The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps.
Croatian: Dvije najčešće dijagnoze povezane s krvarenjem iz maternice tijekom terapije raloksifenom bile su atrofija endometrija i benigni polipi endometrija.
English: The increase correlated with total bilirubin concentrations.
Croatian: Povišenje je koreliralo s koncentracijom ukupnog bilirubina.
English: No cases of raloxifene overdose were reported during clinical trials.
Croatian: Nije bilo prijavljenih slučajeva predoziranja raloksifenom tijekom kliničkih ispitivanja.
English: BOTTLE LABEL, BOTTLE CARTON:
Croatian: NALJEPNICA NA BOCI, KUTIJA ZA BOCU:
English: It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
Croatian: Agonistički djeluje na kosti te djelomično na metabolizam kolesterola (sniženje razine ukupnog i LDL-kolesterola), ali ne i na hipotalamus ili na tkiva maternice ili dojke.
English: No data are available on the concomitant use of Optruma and agents used in the treatment of early or advanced breast cancer.
Croatian: Nema raspoloživih podataka o istodobnom uzimanju Optrume i lijekova koji se koriste u liječenju ranog ili uznapredovalog karcinoma dojke.
English: • If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness as these may increase your risk of blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
Croatian: • Ako ste neko vrijeme imobilizirani, na primjer, ako se koristite invalidskim kolicima, trebate biti primljeni u bolnicu ili trebate ostati u krevetu radi oporavka nakon kirurškog zahvata ili neočekivane bolesti budući da to može povećati rizik za nastanak krvnih ugrušaka (duboka venska tromboza, plućna embolija ili tromboza vene retine).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER BOX FILM COATED TABLETS:
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S BLISTEROM S FILMOM OBLOŽENIM TABLETAMA:
English: Optruma mimics some of the helpful effects of oestrogen after the menopause.
Croatian: Optruma oponaša neke korisne učinke estrogena nakon menopauze.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
English: The majority of side effects seen with Optruma have been mild.
Croatian: Većina nuspojava primijećenih s Optrumom su blage.
English: Optruma belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
Croatian: Optruma pripada skupini lijekova koji nisu hormoni, a koji se nazivaju selektivnim modulatorima estrogenskih receptora.
English: • If you have active uterine cancer, as there is insufficient experience of Optruma use in women with this disease.
Croatian: • Ako imate aktivni karcinom maternice, s obzirom na to da ne postoji dovoljno iskustva s primjenom Optrume u žena s tom bolešću.
English: If you forget to take Optruma
Croatian: Ako ste zaboravili uzeti Optrumu
English: In contrast to the highly responsive ovaries in this rodent model, the human ovary after menopause is relatively unresponsive to reproductive hormonal stimulation.
Croatian: Suprotno ovarijima koji snažno odgovaraju u modelu s glodavcima, ljudski (tj. ženski) ovarij nakon menopauze relativno ne reagira na stimulaciju spolnim hormonima.
English: There was no difference between treatment groups in the incidence of new nonvertebral fractures.
Croatian: Nije bilo razlika između terapijskih skupina u incidenciji novih nevertebralnih prijeloma.
English: This binding results in differential expression of multiple oestrogen-regulated genes in different tissues.
Croatian: Posljedica tog vezanja jest diferencijalna ekspresija multiplih estrogen-reguliranih gena u raznim tkivima.
English: 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.
Croatian: Pri dozama od 0,1 do 10 mg/kg/dan u ženki štakora raloksifen je poremetio estrogenske cikluse kod ženki štakora tijekom liječenja, ali nije odgodio plodno parenje po prekidu liječenja i samo je djelomično smanjio broj mladunčadi, produžio vrijeme gestacije i promijenio vrijeme razvojnih događaja u neonatalnom periodu.
English: As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
Croatian: Kao selektivni modulator estrogenskih receptora (SERM) raloksifen ima selektivna agonistička ili antagonistička djelovanja na tkiva koja podliježu učincima estrogena.
English: Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Croatian: Plazmatske koncentracije raloksifena bile su približno 2,5 puta više od kontrolne skupine i bile su u korelaciji s koncentracijom bilirubina.
English: • Skin around the vein is red and painful (superficial vein thrombophlebitis)
Croatian: • koža oko vene je crvena i bolna (tromboflebitis površinskih vena)
English: The time to reach average maximum plasma concentration and bioavailability are functions of systemic interconversion and enterohepatic cycling of raloxifene and its glucuronide metabolites.
Croatian: Vrijeme potrebno da dosegne prosječnu vršnu koncentraciju u plazmi i bioraspoloživost, funkcije su sistemske interkonverzije i enterohepatičkog kruženja raloksifena i njegovih glukuronidnih metabolita.
English: After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
Croatian: Nakon 4 godine raloksifen nije povećao rizik za karcinom endometrija ili jajnika.
English: The clinically most important adverse reactions reported in postmenopausal women treated with Optruma were venous thromboembolic events (see section 4.4), which occurred in less than 1% of treated patients.
Croatian: Klinički najznačajnije nuspojave prijavljene kod žena u postmenopauzi liječenih Optrumom bili su venski tromboembolijski događaji (vidjeti dio 4.4) koji su se pojavili u manje od 1% liječenih bolesnica.
English: a) Skeletal Effects
Croatian: a) Učinci na skelet
English: Elliptically shaped, white tablets imprinted with the code '4165'.
Croatian: Tablete su eliptičnog oblika, bijele boje, s otisnutom šifrom „4165“.
English: In patients with moderate and mild renal impairment, Optruma should be used with caution.
Croatian: Kod bolesnica sa umjerenim i blagim bubrežnim oštećenjem Optrumu treba uzimati s oprezom.
English: • If you have any unexplained vaginal bleeding.
Croatian: • Ako imate neobjašnjivo krvarenje iz rodnice.
English: The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
Croatian: Odnos rizika i koristi mora se uzeti u obzir kod bolesnica s rizikom nastanka venskih tromboembolijskih događaja bilo koje etiologije.
English: Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.
Croatian: Iako na početku ne moraju postojati simptomi, osteoporoza uzrokuje češće lomove kostiju, naročito kralježnice, kukova i ručnih zglobova i može uzrokovati bolove u leđima, gubitak na visini i pogrbljenost.
English: In the RUTH study overall clinical fractures were collected as a secondary endpoint.
Croatian: U ispitivanju RUTH prikupljeni su podaci o ukupnim kliničkim prijelomima kao sekundarnom ishodu.
English: 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.
Croatian: Nadalje, u ispitivanju u kojemu je primijenjena doza raloksifena 2,5 puta veće od preporučene dnevne doze Optrume nije postojao dokaz o proliferaciji endometrija niti povećanje volumena maternice.
English: Optruma and oestrogen affect bone remodelling and calcium metabolism similarly.
Croatian: Optruma i estrogen slično utječu na pregradnju kosti i metabolizam kalcija.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Raloxifene comprises less than 1 % of the combined concentrations of raloxifene and the glucuronide metabolites.
Croatian: Raloksifen čini manje od 1 % zbrojnih koncentracija raloksifena i glukuronidnih metabolita.
English: A reduction in the risk of hip fractures has not been shown.
Croatian: Nije se pokazalo smanjenje rizika od prijeloma kuka.
English: However, there was an increase in death due to stroke in women assigned to raloxifene.
Croatian: Međutim, postojao je porast smrtnosti uslijed moždanog udara u žena kojima je dodijeljen raloksifen.
English: EXP {MM/YYYY}
Croatian: ROK VALJANOSTI EXP {MM/GGGG}
English: Optruma has no or negligible effects on driving or using machines.
Croatian: Optruma ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima ili strojevima.
English: Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebocontrolled clinical trials of raloxifene in osteoporosis.
Croatian: Blago smanjenje (6-10 %) broja trombocita zabilježeno je tijekom liječenja raloksifenom u placebo kontroliranim kliničkim istraživanjima raloksifena u osteoporozi.
English: • Increased risk of blood clots in the lungs (pulmonary embolism)
Croatian: • povećan rizik od krvnih ugrušaka u plućima (plućna embolija)
English: An effect on non-vertebral fractures has not been demonstrated.
Croatian: Učinak na nevertebralne prijelome nije pokazan.
English: Three trials included 1,764 postmenopausal women who were treated with Optruma and calcium or calcium supplemented placebo.
Croatian: Tri su ispitivanja obuhvatila 1764 žene u postmenopauzi koje su liječene Optrumom i kalcijem ili placebom s nadomjestkom kalcija.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.