FrancophonIA/ELRC3.0 huggingface dataset:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Podrobnije informacije o ovom lijeku dostupne su na internetskim stranicama Europske agencije za lijekove http://www.ema.europa.eu.
English: Raloxifene should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
Croatian: Primjenu raloksifena treba prekinuti u slučaju pojave bolesti ili stanja koja dovode do dugotrajne imobilizacije.
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: - If you have severe kidney problems.
Croatian: Ako imate teške probleme s bubrezima.
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 bolesnica lijek greškom uzme tijekom trudnoće ili tijekom uzimanja lijeka ostane u drugom stanju, treba je upozoriti na moguće opasnosti za fetus (vidjeti dio 5.3).
English: No adverse effects on cognitive function have been seen.
Croatian: Nisu primijećeni nepoželjni učinci na kognitivne funkcije.
English: Raloxifene Teva can treat or prevent your osteoporosis only if you continue to take the tablets.
Croatian: Raloksifen Teva Vam može liječiti ili spriječiti osteoporozu samo ako nastavite uzimati tablete.
English: • Skin around the vein is red and painful (superficial vein thrombophlebitis).
Croatian: • koža oko vene je crvena i bolna (tromboflebitis površinskih vena).
English: Raloxifene 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: Raloksifen je povezan sa smanjenjem resorpcije kosti i sa srednjim pozitivnim pomakom u ravnoteži kalcija od 60 mg na dan, prije svega zbog smanjenog gubitka kalcija urinom.
English: United Kingdom Teva UK Limited Tel: +44 1977628500
Croatian: Teva UK Limited Tel: +44 1977628500
English: Other medicines and Raloxifene Teva
Croatian: Drugi lijekovi i Raloksifen Teva
English: Do not take Raloxifene Teva if you are breast-feeding as it might be excreted in mother's milk.
Croatian: Nemojte uzimati Raloksifen Teva ako dojite jer se lijek može izlučivati u majčino mlijeko.
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 pripravaka bila je dopuštena tijekom programa kliničkih istraživanja 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 rizika za sve pojave VTE događaja u ispitivanju RUTH bio je HR = 1,44, (1,06 - 1,95).
English: Raloxifene (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Croatian: Raloksifen (n = 317) je uspoređivan s kontinuiranom kombiniranom hormonskom nadomjesnom terapijom (HNT) (n = 110) ili cikličkom HNT-om (n = 205) u bolesnica tijekom nekih kliničkih istraživanja.
English: Swensweg 5, 2031 GA, Haarlem The Netherlands
Croatian: Swensweg 5, 2031 GA, Haarlem Nizozemska
English: How to store Raloxifene Teva Contents of the pack and other information
Croatian: Kako čuvati Raloksifen Teva Sadržaj pakiranja i druge informacije
English: Until safety and efficacy have been evaluated further in patients with hepatic insufficiency, the use of raloxifene is not recommended in this patient population.
Croatian: Dok se dodatno ne procijene sigurnost i djelotvornost u bolesnika s insuficijencijom jetre, uzimanje raloksifena ne preporučuje se toj skupini bolesnika.
English: This binding results in differential expression of multiple oestrogen-regulated genes in different tissues.
Croatian: Posljedica tog vezanja jest diferencijalna ekspresija višestrukih estrogen-reguliranih gena u raznim tkivima.
English: 14 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Croatian: Filmom obložena tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 84 filmom obložene tablete
English: Nervous system disorders Common: Headache, including migraine a
Croatian: Poremećaji živčanog sustava Često: glavobolja, uključujući migrenua
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 April 2010
Croatian: Datum prvog odobrenja: 29. travnja 2010.
English: What you need to know before you take Raloxifene Teva
Croatian: Što morate znati prije nego počnete uzimati Raloksifen Teva
English: • Hot flushes (vasodilatation).
Croatian: • navale vrućine (vazodilatacija).
English: If you take more Raloxifene Teva than you should you could have leg cramps and dizziness.
Croatian: Ako uzmete više Raloksifena Teva nego što ste trebali mogu se pojaviti grčevi u nogama i omaglica.
English: Raloxifene therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Croatian: Terapija raloksifenom u trajanju od 8 godina nije značajno utjecala na rizik od nastanka srčano krvožilnih događaja u bolesnica uključenih u ispitivanje liječenja osteoporoze.
English: There is no relevant use of Raloxifene in the paediatric population.
Croatian: Nema relevantne primjene Raloksifena u pedijatrijskoj populaciji.
English: Endometrial biopsies taken after six months therapy with raloxifene 60 mg daily demonstrated non-proliferative endometrium in all patients.
Croatian: Biopsije endometrija uzete nakon šestomjesečne terapije raloksifenom u dozi od 60 mg na dan u svih su bolesnica pokazale neproliferativni endometrij.
English: Raloxifene Teva is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Croatian: Raloksifen Teva primjenjuje se isključivo u žena u postmenopauzi i ne smiju ga uzimati žene koje još uvijek mogu zatrudnjeti.
English: If you forget to take Raloxifene Teva Take a tablet as soon as you remember and then continue as before.
Croatian: Uzmite tabletu čim se sjetite i potom nastavite kao prije.
English: - If you have any unexplained vaginal bleeding.
Croatian: Ako imate neobjašnjivo krvarenje iz rodnice.
English: • Increased risk of blood clots in the lungs (pulmonary embolism).
Croatian: • povećan rizik od krvnih ugrušaka u plućima (plućna embolija).
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A.
Croatian: België/Belgique/Belgien
English: Raloxifene does not stimulate breast tissue.
Croatian: Raloksifen ne stimulira tkivo dojke.
English: Therefore, raloxifene should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Croatian: Stoga raloksifen treba uzimati u liječenju i prevenciji osteoporoze samo nakon što je liječenje karcinoma dojke, uključujući i adjuvantnu terapiju, završeno.
English: No cases of raloxifene overdose were reported during clinical trials.
Croatian: Nije bilo prijavljenih slučajeva predoziranja raloksifenom tijekom kliničkih istraživanja.
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 od nastanka venskih tromboembolijskih događaja bilo koje etiologije.
English: It is unlikely that Raloxifene Teva will cause vaginal bleeding.
Croatian: Nije vjerojatno da će Raloksifen Teva uzrokovati krvarenje iz rodnice.
English: 6.5 Nature and contents of container Transparent PVC/PVdC - Aluminium blisters.
Croatian: Prozirni PVC/PVdC - aluminijski blisteri.
English: Teva UK Ltd, Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG UK
Croatian: Teva UK Ltd, Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG Velika Britanija
English: th 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: 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: Tél: +(33) 1 55 91 7800
Croatian: Teva Santé Tél: +(33) 1 55 91 7800
English: There was no difference between treatment groups in the incidence of new nonvertebral fractures.
Croatian: Nije bilo razlika između terapijskih skupina u učestalosti pojave novih nevertebralnih prijeloma.
English: No data are available on the concomitant use of raloxifene and agents used in the treatment of early or advanced breast cancer.
Croatian: Nema raspoloživih podataka o istodobnom uzimanju raloksifena i lijekova koji se koriste u liječenju ranog ili uznapredovalog karcinoma dojke.
English: Polydextrose (E1200) Titanium dioxide (E171) Hypromellose (E464) Macrogol 4000
Croatian: Ovojnica tablete: polidekstroza (E1200) titanijev dioksid (E171) hipromeloza (E464) makrogol 4000
English: What Raloxifene Teva is and what it is used for What you need to know before you take Raloxifene Teva How to take Raloxifene Teva Possible side effects
Croatian: Što je Raloksifen Teva i za što se koristi Što morate znati prije nego počnete uzimati Raloksifen Teva Kako uzimati Raloksifen Teva
English: After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
Croatian: Nakon 4 godine raloksifen nije povećao rizik od karcinoma endometrija ili jajnika.
English: Do not use this medicine after the expiry date which is stated on the outer carton or foil after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili foliji iza oznake “EXP”.
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 ovisi o sistemskoj interkonverziji i enterohepatičkom kruženju raloksifena i njegovih glukuronidnih metabolita.
English: In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene Teva.
Croatian: U rijetkim slučajevima, razine jetrenih enzima u krvi mogu porasti za vrijeme liječenja lijekom
English: When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Croatian: Prilikom odluke o izboru raloksifena ili drugih terapija, uključujući i estrogene, u pojedinih žena u postmenopauzi moraju se uzeti u obzir simptomi menopauze, učinci na tkivo maternice i dojke te srčano-krvožilni rizici i koristi (vidjeti dio 5.1).
English: In addition, in a study with 2.5 x the recommended daily dose of raloxifene 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 raloksifena nije postojao dokaz o proliferaciji endometrija niti povećanje volumena maternice.
English: The film-coated tablets are white to off-white, oval shaped and embossed with the number “60” on one side and “N” on the other side.
Croatian: Filmom obložene tablete su bijele do gotovo bijele, ovalnog oblika s utisnutom oznakom „60” na jednoj strani i „N” na drugoj strani.
English: The clinically most important adverse reactions reported in postmenopausal women treated with Raloxifen 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 Raloksifenom bili su venski tromboembolijski događaji (vidjeti dio 4.4) koji su se pojavili u manje od 1% liječenih bolesnica.
English: • Risk Management Plan (RMP)
Croatian: LIJEKA • Plan upravljanja rizikom
English: Raloxifene Teva 60 mg is available in pack sizes of 14, 28 and 84 film-coated tablets.
Croatian: Raloksifen Teva 60 mg dostupan je u pakiranjima sa 14, 28 i 84 filmom obložene tablete.
English: White to off-white, film coated, oval shaped tablets, embossed with the number “60” on one side and “N” on the other side of the tablet.
Croatian: Bijela do gotovo bijela, filmom obložena tableta ovalnog oblika s utisnutom oznakom „60“ na jednoj strani i „N“ na drugoj strani.
English: Raloxifene and oestrogen affect bone remodelling and calcium metabolism similarly.
Croatian: Raloksifen i estrogen slično utječu na pregradnju kosti i metabolizam kalcija.
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: Raloksifen je povezan s povećanim rizikom od razvoja venskih tromboembolijskih događaja koji je sličan onom prijavljenom pri primjeni hormonske nadomjesne terapije.
English: In postmenopausal women with osteoporosis, raloxifene reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Croatian: U žena u postmenopauzi koje boluju od osteoporoze raloksifen smanjuje incidenciju prijeloma kralježaka, čuva koštanu masu i povećava mineralnu gustoću kostiju (BMD, bone mineral density).
English: After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9 % of the 211 women treated with raloxifene 60 mg/day compared to 1.8 % of the 219 women who received placebo.
Croatian: Nakon trogodišnjeg liječenja, transvaginalnim ultrazvukom izmjereno je povećanje debljine endometrija od najmanje 5 mm u 1,9 % od 211 žena koje su liječene raloksifenom u dozi od 60 mg/dan u usporedbi s 1,8 % od 219 žena koje su dobivale placebo.
English: Frequently co-administered medicinal products included: paracetamol, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, ibuprofen, and naproxen), oral antibiotics, H1 antagonists, H2 antagonists, and benzodiazepines.
Croatian: paracetamol, nesteroidne protuupalne lijekove (kao što su acetilsalicilatna kiselina, ibuprofen i naproksen), oralne antibiotike, H1-antagoniste, H2-antagoniste i benzodiazepine.
English: Effects on prothrombin time may develop over several weeks if raloxifene 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 bolesnicama koje već uzimaju kumarinsku antikoagulantnu terapiju uvede terapija raloksifenom.
English: What Raloxifene Teva looks like and contents of the pack
Croatian: Kako Raloksifen Teva izgleda i sadržaj pakiranja
English: Raloxifene has no or negligible influence on the ability to drive and use machines.
Croatian: Raloksifen nema ili ima zanemariv utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Deutschland Teva GmbH Tel: +49 73140208
Croatian: Teva GmbH Tel: +49 73140208
English: Based on these risk factors, prevention of osteoporosis with raloxifene 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.
Croatian: Na temelju navedenih rizičnih čimbenika prevencija osteoporoze raloksifenom indicirana je u žena unutar deset godina od nastupa menopauze, s vrijednošću BMD-a kralježnice u rasponu od 1,0 do 2,5 SD ispod srednje vrijednosti zdrave mlade populacije, uzimajući u obzir visoki doživotni rizik od nastanka osteoporotičnih prijeloma.
English: Raloxifene should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Croatian: Raloksifen ne smiju uzimati bolesnice s oštećenjem jetre (vidjeti dio 4.3 i 4.4).
English: In a study comparing raloxifene with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
Croatian: U ispitivanju u kojem je uspoređivan raloksifen s estrogenom, kosti bolesnica koje su liječene jednim od lijekova bile su histološki uredne, bez dokaza o poremećaju mineralizacije, iskrivljenju kostiju ili fibrozi srži.
English: Raloxifene Teva mimics some of the helpful effects of oestrogen after the menopause.
Croatian: Raloksifen Teva oponaša neke korisne učinke estrogena nakon menopauze.
English: - If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice).
Croatian: Ako imate bolest jetre (primjeri bolesti jetre uključuju cirozu, blago oštećenje jetre ili kolestatsku žuticu).
English: Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
Croatian: Istodobna primjena antacida koji sadrže kalcijev karbonat ili aluminijev i magnezijev hidroksid ne utječe na sistemsku raspoloživost raloksifena.
English: Raloxifene decreases resorption of bone; this effect on bone is manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in BMD and decreases in the incidence of fractures.
Croatian: Raloksifen smanjuje resorpciju kosti; taj učinak na kosti iskazuje se smanjenjem razine biljega koštane pregradnje u serumu i urinu, smanjenjem resorpcije kosti na temelju ispitivanja kinetike radioaktivnoobilježenog kalcija, povećanjem BMD-a i smanjenjem inicidencije prijeloma.
English: Raloxifene should not be co-administered with cholestyramine (or other anion exchange resins), which significantly reduces the absorption and enterohepatic cycling of raloxifene.
Croatian: Raloksifen se ne smije istodobno primjenjivati s kolestiraminom (ili s drugim anion izmjenjivačkim smolama), koji značajno smanjuje apsorpciju i enterohepatično kruženje raloksifena.
English: Presystemic glucuronidation is exten sive.
Croatian: Predsistemska glukuronidacija je opsežna.
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.
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), što je popraćeno povišenjem ukupnih koncentracija hormona.
English: In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/kg, and prostatic leiomyoblastoma in males given 210 mg/kg.
Croatian: U ispitivanju karcinogenosti u miševa u trajanju od 21 mjeseca zabilježena je veća incidencija tumora intersticijskih stanica testisa i adenoma i adenokarcinoma prostate u mužjaka koji su dobivali 41 ili 210 mg/kg i leiomioblastoma u mužjaka koji su dobivali 210 mg/kg.
English: The safety of raloxifene in patients with breast cancer has not been adequately studied.
Croatian: Sigurnost primjene raloksifena u bolesnica s karcinomom dojke nije dovoljno ispitivana.
English: Raloxifene 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: Raloksifen ne smiju uzimati bolesnice sa znacima ili simptomima karcinoma endometrija jer u njih sigurnost još nije primjereno ispitana.
English: Raloxifene is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
Croatian: Raloksifen nije učinkovit u smanjivanju vazodilatacije (navala crvenila uz osjećaj vrućine) niti drugih simptoma menopauze povezanih s manjkom estrogena.
English: Marketing Authorisation Holder: Teva B.V.
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka: Teva B.V.
English: A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Croatian: Pokazalo se da značajno smanjuje incidenciju prijeloma kralježaka, ali ne i kuka.
English: Likewise, raloxifene is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/or with vertebral fractures, irrespective of BMD.
Croatian: Također, raloksifen je indiciran u liječenju osteoporoze ili utvrđene osteoporoze u žena s vrijednošću BMD kralježnice od 2,5 SD ispod srednje vrijednosti zdrave mlade populacije i/ili s prijelomima kralježaka neovisno o BMD-u.
English: In patients with moderate and mild renal impairment, raloxifene should be used with caution.
Croatian: Kod bolesnica s umjerenim i blagim bubrežnim oštećenjem raloksifen treba uzimati s oprezom.
English: If you stop taking Raloxifene Teva
Croatian: Ako prestanete uzimati Raloksifen Teva
English: In the osteoporosis treatment study, significantly fewer raloxifene-treated patients required initiation of hypolipidaemic therapy compared to placebo.
Croatian: U ispitivanju liječenja osteoporoze značajno manji broj bolesnica liječenih raloksifenom zahtijevao je uvođenje hipolipemičke terapije u usporedbi sa skupinom koja je primala placebo.
English: Raloxifene Teva belongs to a group of non-hormonal medicines called selective oestrogen receptor modulators (SERMs).
Croatian: Kako Raloksifen Teva djeluje Raloksifen Teva pripada skupini lijekova koji nisu hormoni, a koji se nazivaju selektivnim modulatorima estrogenskih receptora.
English: - If you have liver problems, as there is insufficient experience in people with liver problems.
Croatian: − Ako imate problema s jetrom, budući da ne postoji dovoljno iskustvo s primjenom lijeka u ljudi s takvim problemima.
English: Three trials included 1,764 postmenopausal women who were treated with raloxifene and calcium or calcium supplemented placebo.
Croatian: Tri su istraživanja obuhvatila 1764 žene u postmenopauzi koje su liječene raloksifenom i kalcijem ili placebom s nadomjestkom kalcija.
English: In clinical trials, raloxifene did not stimulate the postmenopausal uterine endometrium.
Croatian: U kliničkim istraživanjima raloksifen nije stimulirao endometrij maternice u postmenopauzi.
English: Raloxifene should not be used in children of any age.
Croatian: Raloksifen ne smiju uzimati djeca bilo koje dobi.
English: - The active substance is raloxifene hydrochloride.
Croatian: - Djelatna tvar je raloksifenklorid.
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 dovodi do povećanja površine ispod krivulje koncentracije u plazmi prema vremenu (AUC) koje je nešto manje od proporcionalnog.
English: TEVA Pharmaceutical Works Private Limited Company Pallagi ùt 13, 4042 Debrecen Hungary
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet TEVA Pharmaceutical Works Private Limited Company Pallagi ùt 13, 4042 Debrecen