FrancophonIA/ELRC3.0 huggingface dataset:
English: Although they have theoretically interesting hormonal effects, their concentrations during toremifene treatment are too low to have any major biological importance.
Croatian: Iako imaju teoretski zanimljive hormonske učinke njihove koncentracije tijekom liječenja toremifenom preniske su da bi imali veći biološki značaj.
English: In human serum the main metabolite is N-demethyltoremifene with mean half-life of 11 (range 4 - 20) days.
Croatian: U ljudskom serumu glavni metabolit je N-demetiltoremifen s prosječnim poluvijekom od 11 (4 - 20 dana) dana.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnice s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Metabolism and nutrition disorders loss of appetite
Croatian: Poremećaji metabolizma i prehrane gubitak apetita
English: A QT clinical study with a 5-arm parallel design (placebo, moxifloxacin 400 mg, toremifene 20 mg, 80 mg, and 300 mg) has been performed in 250 male patients to characterize the effects of toremifene on the QTc interval duration.
Croatian: Kliničko ispitivanje QT s dizajnom od pet usporednih skupina (placebo, moksifloksacin 400 mg, toremifen 20 mg, 80 mg i 300 mg) provedeno je na 250 muških pacijenata kako bi se odredili učinci toremifena na trajanje QTc intervala.
English: Concomitant use of those drugs with toremifene should be carefully considered.
Croatian: Istodobna primjena tih lijekova s toremifenom mora se pažljivo razmotriti.
English: Action potential studies in isolated rabbit heart have shown that toremifene induce cardiac electrophysiological changes which start to develop at concentrations approximately 10 fold compared to the calculated free therapeutic plasma concentration in human.
Croatian: Ispitivanja akcijskog potencijala na izoliranom srčanom tkivu kunića pokazala su da toremifen inducira elektrofiziološke promjene na srcu koje se počinju razvijati pri koncentracijama od približno 10 puta većim od izračunate slobodne terapijske koncentracije u ljudskoj plazmi.
English: Breast-feeding In rats, decreased body weight gain of the offspring during lactation was observed.
Croatian: Dojenje U štakora je uočena smanjena tjelesna težina potomaka tijekom dojenja.
English: Patients with non-compensated cardiac insufficiency or severe angina pectoris should be closely monitored.
Croatian: Bolesnice s dekompenziranom srčanom insuficijencijom ili teškom anginom pektoris se mora pomno nadzirati.
English: Fertility Toremifene is recommended for postmenopausal patients.
Croatian: Plodnost Toremifen se preporučuje za liječenje postmenopauzalnih bolesnica.
English: Package sizes: 30 and 100 tablets.
Croatian: Veličine pakiranja: 30 i 100 tableta.
English: These findings are postulated to be of little relevance for the safety in man, where toremifene acts mainly as an anti-estrogen.
Croatian: Smatra se da ti nalazi nisu jako važni za sigurnost u ljudi gdje toremifen djeluje uglavnom kao anti-estrogen.
English: Thromboembolic events include deep venous thrombosis, thrombophlebitis and pulmonary embolism (see also section 4.4).
Croatian: Tromboembolijski događaji uključuju duboku vensku trombozu, tromboflebitis i plućnu emboliju (vidjeti također dio 4.4).
English: The anti-tumour effect of toremifene in breast cancer is mainly due to the anti-estrogenic effect, although other mechanisms (changes in oncogene expression, growth factor secretion, induction of apoptosis and influence on cell cycle kinetics) may also be involved in the anti-tumour effect.
Croatian: Antitumorski učinak toremifena u raku dojke je uglavnom uzrokovan antiestrogenim učinkom, iako i drugi mehanizmi (promjene u ekspresiji onkogena, lučenje faktora rasta, indukcija apoptoze i utjecaj na kinetiku staničnog ciklusa) također mogu sudjelovati u antitumorskom učinku.
English: Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
Croatian: Starije bolesnice mogu također biti osjetljivije na učinke na QT interval uzrokovane lijekom.
English: Therefore, the concomitant use of toremifene with such drugs should be avoided.
Croatian: Stoga se mora izbjegavati istodobna primjena toremifena s takvim lijekovima.
English: An additive effect on QT interval prolongation between Fareston and the following drugs and other medicinal products that may prolong the QTc interval cannot be excluded.
Croatian: Dodatni učinak prolongacije QT intervala između Farestona i sljedećih lijekova te drugih lijekova koji mogu produljiti QTc interval ne može se isključiti.
English: If you forget to take Fareston
Croatian: Ako ste zaboravili uzeti Fareston
English: The usual dose is one 60 mg tablet taken orally, once daily.
Croatian: Uobičajena doza je jedna tableta od 60 mg uzeta kroz usta, jednom dnevno.
English: The mean concentration of toremifene at steady-state is 0.9 (range 0.6 - 1.3) µg/ml at the recommended dose of 60 mg per day.
Croatian: Prosječna koncentracija toremifena u stanju dinamičke ravnoteže je 0,9 (raspon 0,6 - 1,3) µg/ml pri preporučenoj dozi od 60 mg na dan.
English: As other members of this class, e.g. tamoxifen and clomifene, toremifene binds to estrogen receptors and may produce estrogenic, anti-estrogenic or both effects, depending upon the duration of treatment, animal species, gender, target organ and variable selected.
Croatian: Kao i drugi lijekovi ove skupine primjerice tamoksifen i klomifen, toremifen se veže na estrogenske receptore i može imati estrogene, antiestrogene ili obje vrste učinka ovisno o trajanju liječenja, životinjskoj vrsti, spolu, ciljnom organu i odabranoj varijabli.
English: Very common side effects (may affect more than 1 in 10 people ) - hot flushes, sweating.
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba) - navale vrućine, znojenje.
English: The main metabolic pathway, N-demethylation, is mediated mainly by CYP3A.
Croatian: Glavni metabolički put razgradnje, N-demetilacija je uglavnom posredovana enzimom CYP3A.
English: In some experimental cancers and/or using high-dose, toremifene displays anti-tumour effects which are not estrogen-dependent.
Croatian: U nekim eksperimentalnim liječenjima raka i/ili kod uporabe visokih doza toremifen iskazuje antitumorske učinke koji ne ovise o estrogenu.
English: What you need to know before you take Fareston
Croatian: Što morate znati prije nego počnete uzimati Fareston
English: Patients with additional risk of endometrial cancer, e.g. patients suffering from hypertension or diabetes, having high BMI (> 30) or history of hormone replacement therapy should be closely monitored (see also section 4.8).
Croatian: Bolesnice s dodatnim rizikom od raka endometrija, primjerice bolesnice koje boluju od hipertenzije ili dijabetesa, osobe s visokim BMI (> 30) ili anamnezom hormonske nadomjesne terapije se mora pomno nadzirati (vidjeti također dio 4.8).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1996
Croatian: Datum prvog odobrenja: 14. veljače 1996.
English: Fareston increases the QT interval in a dose-related manner (see also section 4.4).
Croatian: Fareston povećava QT interval na način ovisan o dozi (vidjeti također dio 4.4).
English: As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications.
Croatian: Budući da žene u pravilu imaju dulji QTc interval od muškaraca, mogu biti osjetljivije na lijekove koji produljuju QTc.
English: - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias.
Croatian: - klinički značajnom bradikardijom - klinički značajnim zatajenjem srca sa smanjenom ejekcijskom frakcijom lijeve klijetke - prethodnom anamnezom simptomatskih aritmija.
English: Your doctor will conduct regular medical checkups if you have high blood pressure, diabetes, have taken hormone replacement therapy or if you are obese (BMI over 30).
Croatian: Vaš će liječnik redovito obavljati medicinske provjere ako imate visoki krvni tlak, dijabetes, ako ste uzeli nadomjesnu hormonsku terapiju ili ako ste pretili (indeks tjelesne mase iznad 30).
English: (hypokalaemia) which are currently not corrected by treatment - if you have a very slow heart rate (bradycardia) - if you have a heart failure - if you have a history of abnormal heart rhythms (arrhythmias) - if you are taking other medicines that may affect your heart (see section 2 Other medicines and
Croatian: (hipokalijemija), koja nije pod liječničkom kontrolom - ako imate vrlo spore otkucaje srca (bradikardija) - ako imate srčano zatajenje - ako imate anamnezu poremećenog srčanog ritma (aritmije) - ako uzimate druge lijekove koji mogu djelovati na Vaše srce (pogledajte dio 2 Drugi lijekovi i
English: You should contact your doctor immediately if you notice any of the following: - swelling or tenderness in your calf - unexplained shortness of breath or sudden chest pain - vaginal bleeding or changes in vaginal discharge.
Croatian: Morate odmah obavijestiti svog liječnika ako primijetite bilo koje od sljedećeg: - oticanje ili osjetljivost u stražnjem dijelu potkoljenice - neobjašnjiv nedostatak zraka ili iznenadna bol u prsnom košu - vaginalno krvarenje ili promjene u vaginalnom iscjetku.
English: White, round, flat, bevelled edge tablet with TO 60 on one side.
Croatian: Bijela, okrugla, plosnata tableta ukošenog ruba, s oznakom TO 60 na jednoj strani.
English: The elimination of toremifene and its metabolites was significantly increased in patients with activated liver function and decreased in patients with impaired liver function.
Croatian: Eliminacija toremifena i njegovih metabolita znatno je povećana u bolesnica s aktiviranom jetrenom funkcijom i smanjena u bolesnica s oštećenom jetrenom funkcijom.
English: Toremifene has no influence on the ability to drive and use machines.
Croatian: Toremifen ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The pattern of the liver damage was predominantly hepatocellular.
Croatian: Oštećenje jetre pretežno je bilo hepatocelularnog tipa.
English: Fareston causes certain abnormal changes in the electrical recording of the heart (electrocardiogram or ECG).
Croatian: Fareston može izazvati promjene u snimanju električne aktivnosti srca (elektrokardiogram ili EKG).
English: Toremifene binds specifically to estrogen receptors, competitively with oestradiol, and inhibits estrogeninduced stimulation of DNA synthesis and cell replication.
Croatian: Toremifen se specifično veže na estrogenske receptore, natječući se s estradiolom, te inhibirajući estrogenom induciranu stimulaciju sinteze DNK i replikaciju stanica.
English: Non clinical in vitro and in vivo studies have evidenced the potential of toremifene and its metabolite to prolong cardiac repolarisation and this can be attributed to the blockade of hERG channels.
Croatian: Neklinička ispitivanja in vitro te in vivo dokazala su potencijal toremifena i njegovih metabolita za produljivanjem srčane repolarizacije, što se može pripisati blokadi hERG kanala.
English: If signs or symptoms that may be associated with cardiac arrhythmia occur during treatment with Fareston, treatment should be stopped and an ECG should be performed.
Croatian: Ako se tijekom liječenja Farestonom pojave znakovi ili simptomi koji mogu biti povezani sa srčanom aritmijom, liječenje se mora prekinuti i mora se učiniti EKG.
English: Theoretically the metabolism of toremifene is inhibited by drugs known to inhibit the CYP3A enzyme system which is reported to be responsible for its main metabolic pathways.
Croatian: Teoretski, metabolizam toremifena je inhibiran lijekovima za koje se zna da inhibiraju sustav enzima CYP3A koji je odgovoran za glavne putove metaboličke razgradnje toremifena.
English: Enzyme complex, known to be responsible for the metabolism of toremifene in humans, is cytochrome P450-dependent hepatic mixed function oxidase.
Croatian: Enzimski kompleks za koji se zna da je odgovoran za metabolizam toremifena u ljudi je citokrom P450 ovisna jetrena oksidaza mješovite funkcije.
English: Toremifene is a nonsteroidal triphenylethylene derivative.
Croatian: Toremifen je nesteroidni derivat trifeniletilena.
English: Do not take Fareston together with the following medicines as there is an increased risk that your heartbeat may be altered (see section 2 Do not take Fareston): - medicines used to treat abnormal heart rhythm (antiarrhythmics); such as quinidine,
Croatian: Nemojte uzimati Fareston zajedno sa sljedećim lijekovima jer postoji povećani rizik za promjenu otkucaja Vašeg srca (pogledajte dio 2 Nemojte uzimati Fareston): - lijekove za liječenje nenormalnog srčanog ritma (antiaritmici); poput kinidina, hidrokinidina,
English: For reasons of drug safety, toremifene is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia
Croatian: Zbog sigurnosnih razloga toremifen je stoga kontraindiciran u bolesnica s: - kongenitalnim ili dokumentiranim stečenim produljenjem QT segmenta - poremećajima elektrolita, posebice neliječenom hipokalijemijom
English: Fareston is used for the treatment of a certain type of breast tumour in women who have had their menopause.
Croatian: Fareston se koristi za liječenje određene vrste tumora dojke u žena poslije menopauze.
English: What Fareston looks like and contents of the pack White, round, flat, bevelled edge tablet with TO 60 on one side.
Croatian: Kako Fareston izgleda i sadržaj pakiranja Bijela, okrugla, plosnata tableta ukošenog ruba, s oznakom TO 60 na jednoj strani.
English: Its steady-state concentrations are about twice compared to those of the parent compound.
Croatian: Njegove koncentracije u stanju dinamičke ravnoteže su oko dva puta veće u usporedbi s koncentracijama ishodišnog spoja.
English: In post-menopausal breast cancer patients, toremifene treatment is associated with modest reductions in both total serum cholesterol and low density lipoprotein (LDL).
Croatian: U postmenopauzalnih bolesnica s rakom dojke, liječenje toremifenom povezano je s umjerenom redukcijom i serumskog kolesterola i lipoproteina niske gustoće (LDL).
English: Hypercalcemia may occur at the beginning of toremifene treatment in patients with bone metastasis and thus these patients should be closely monitored.
Croatian: Hiperkalcijemija se može pojaviti u početku liječenja toremifenom u bolesnica s metastazama u kostima, i stoga te bolesnice moraju biti pomno nadzirane.
English: In mice, estrogens induce ovarian and testicular tumours as well as hyperostosis and osteosarcomas.
Croatian: U miševa, estrogeni su inducirali tumore jajnika i testisa, kao i hiperostozu i osteosarkome.
English: Fareston is not recommended for patients with estrogen receptor negative tumours.
Croatian: Fareston se ne preporučuje za bolesnice čiji su tumori negativni na estrogenski receptor.
English: There are no systematic data available from patients with labile diabetes, from patients with severely altered performance status or from patients with cardiac failure.
Croatian: Nisu dostupni sistematizirani podaci za bolesnice s nereguliranim dijabetesom, bolesnica s teško promijenjenim funkcionalnim stanjem ili za bolesnice sa zatajenjem srca.
English: endometrial cancer
Croatian: rak endometrija
English: Driving and using machines Fareston has no influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Fareston nema utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: LIST OF EXCIPIENTS lactose monohydrate
Croatian: POPIS POMOĆNIH TVARI laktoza monohidrat
English: There are no adequate data from the use of Fareston in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni Farestona u trudnica.
English: One tablet contains 28.5 mg of lactose.
Croatian: Jedna tableta sadrži 28,5 mg laktoze.
English: Vascular disorders hot flushes thromboembolic events
Croatian: Krvožilni poremećaji navale vrućine tromboembolijski događaji
English: Patients with a history of severe thromboembolic disease should generally not be treated with toremifene (see also section 4.8).
Croatian: Bolesnice s anamnezom teške tromboembolijske bolesti se općenito ne smije liječiti toremifenom (vidjeti također dio 4.8).
English: Enzyme inducers, like phenobarbital, phenytoin and carbamazepine, may increase the rate of toremifene metabolism thus lowering the steady-state concentration in serum.
Croatian: Induktori enzima poput fenobarbitala, fenitoina i karbamazepina mogu povećati brzinu metabolizma toremifena snižavajući tako stanje dinamičke ravnoteže koncentracije u serumu.
English: Toremifene has a species-specific estrogen-like effect in mice and causes similar tumours.
Croatian: Toremifen ima za vrstu specifičan učinak nalik estrogenu kao u miševa te uzrokuje slične tumore.
English: Your doctor may advise you to stop taking Fareston and perform a medical test to see how your heart is working (ECG).
Croatian: Liječnik Vam može savjetovati da prestanete uzimati Fareston i obavite medicinsku pretragu koja će pokazati kako Vaše srce radi (EKG) (pogledajte dio 2 Nemojte uzimati Fareston).
English: Three minor metabolites have been detected in human serum: (deaminohydroxy)toremifene, 4-hydroxytoremifene, and N,N-didemethyltoremifene.
Croatian: U ljudskom serumu uočena su tri manje važna metabolita: (deaminohidroksi)toremifen, 4hidroksitoremifen i N,N-didemetiltoremifen.
English: EU/1/96/004/002 100 tablets
Croatian: EU/1/96/004/002 100 tableta
English: It has similar anti-estrogenic, albeit weaker anti-tumour activity than the parent compound.
Croatian: Ima sličnu antiestrogenu, iako slabiju antitumorsku aktivnost od ishodišnog spoja.
English: Drugs which decrease renal calcium excretion, e.g. thiazide diuretics, may increase the risk of hypercalcaemia.
Croatian: Lijekovi koji smanjuju bubrežno izlučivanje kalcija poput tiazidskih diuretika mogu povećati rizik od hiperkalcemije.
English: Frequency not known (cannot be estimated from the available data) - low number of white blood cells, which are important in fighting infection (leukopenia) - low number of red blood cells (anaemia) - low number of platelets (thrombocytopenia)
Croatian: Nepoznata učestalost (ne može se procijeniti iz dostupnih podataka) - nizak broj bijelih krvnih stanica koje su važne u borbi protiv infekcija (leukopenija) - nizak broj crvenih krvnih stanica (anemija)
English: Characteristics in patients
Croatian: Karakteristike u bolesnica
English: Fareston contains the active substance toremifene, an anti-estrogen.
Croatian: Fareston sadrži djelatnu tvar toremifen, anti-estrogen.
English: Pharmacokinetics of toremifene were investigated in an open study with four parallel groups of ten subjects: normal subjects, patients with impaired (mean AST 57 U/L - mean ALT 76 U/L - mean gamma GT 329 U/L) or activated liver function (mean AST 25 U/L - mean ALT 30 U/L - mean gamma GT 91 U/L - patients treated with antiepileptics) and patients with impaired renal function (creatinine: 176 µmol/L).
Croatian: Farmakokinetika toremifena ispitivana je u otvorenom ispitivanju s četiri usporedne skupine od deset ispitanica: zdrave ispitanice, bolesnice s oštećenom (prosječna AST 57 U/l - prosječna ALT 76 U/lprosječna gama GT 329 U/l) ili aktiviranom jetrenom funkcijom (prosječna AST 25 U/l - prosječna ALT 30 U/l - prosječna gama GT 91 U/l - bolesnice liječene antiepilepticima) i bolesnice s oštećenom bubrežnom funkcijom (kreatinin: 176 µmol/l).
English: In this study the kinetics of toremifene in patients with impaired renal function were not significantly altered as compared to normal subjects.
Croatian: U ovom ispitivanju kinetika toremifena u bolesnica s oštećenom bubrežnom funkcijom nije se značajnije mijenjala u usporedbi sa zdravim ispitanicama.
English: - Pre-existing endometrial hyperplasia and severe hepatic failure are contra-indications in long term use of toremifene.
Croatian: - Anamneza hiperplazije endometrija i teško zatajenje jetre kontraindikacije su za dugoročnu uporabu toremifena.
English: In general, however, nonsteroidal triphenylethylene derivatives are predominantly antiestrogenic in rats and man and estrogenic in mice.
Croatian: Općenito su nesteroidni trifeniletilenski derivati uglavnom antiestrogeni u štakora i ljudi dok u miševa iskazuju estrogeno djelovanje.
English: A few cases of hypercalcaemia have been reported in patients with bone metastases at the beginning of toremifene treatment.
Croatian: Nekoliko slučajeva hiperkalcijemije uočeno je u bolesnica s metastazama u kostima u početku liječenja toremifenom.
English: Fareston has been shown to prolong the QTc interval on the electrocardiogram in some patients in a dose-related manner.
Croatian: Dokazano je da Fareston produljuje QTc interval na elektrokardiogramu u nekih bolesnica što je u vezi s primijenjenom dozom lijeka.
English: The most frequent adverse reactions are hot flushes, sweating, uterine bleeding, leukorrhea, fatigue, nausea, rash, itching, dizziness and depression.
Croatian: Najčešće nuspojave su navale vrućine, znojenje, krvarenje maternice, leukoreja, umor, mučnina, osip, svrbež, omaglica i depresija.
English: Hepatic impairment Toremifene should be used cautiously in patients with liver impairment (see section 5.2).
Croatian: Oštećenje jetrene funkcije Toremifen se u bolesnika s oštećenom jetrenom funkcijom mora primijeniti s oprezom (vidjeti dio 5.2).
English: Fareston should not be used during pregnancy.
Croatian: Fareston se ne smije primjenjivati tijekom trudnoće.
English: How to take Fareston
Croatian: Kako uzimati Fareston
English: - if you have unstable diabetes - if your general well-being is severely deteriorated - if you have previously had a condition in which blood clots formed in blood vessels, for example in your lungs (lung embolism) or in the veins of your legs (deep vein thrombosis).
Croatian: - ako imate neregulirani dijabetes - ako je Vaše opće stanje jako narušeno - ako ste ranije imali stanje u kojem je dolazilo do stvaranja ugrušaka u krvnim žilama, na primjer u plućima (plućna embolija) ili u venama nogu (duboka venska tromboza)
English: Toremifene treatment has been associated with changes in liver enzyme levels (increases of transaminases) and in very rare occasions with more severe liver function abnormalities (jaundice).
Croatian: Liječenje toremifenom povezano je s promjenama u razinama jetrenih enzima (porasti transaminaza) te u vrlo rijetkim slučajevima s teškim abnormalnostima jetrene funkcije (žutica).
English: Toremifene is extensively metabolised.
Croatian: Toremifen podliježe opsežnom metabolizmu.
English: Reproductive system and uterine bleeding endometrial hypertrophy endometrial polyps endometrial hyperplasia,
Croatian: Poremećaji reproduktivnog sustava i dojki krvarenje maternice, leukoreja hipertrofija endometrija polipi endometrija hiperplazija endometrija
English: Toremifene should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Croatian: Toremifen se ne smije koristiti istodobno s drugim lijekovima koji produljuju QT interval (vidjeti također dio 4.5).
English: In particular please tell your doctor if you are taking any of the following: - water tablets (diuretics of thiazide type) - medicines to prevent blood clotting such as warfarin - medicines used to treat epilepsy such as carbamazepine, phenytoin, phenobarbital - medicines used to treat fungal infections such as ketoconazole, itraconazole, voriconazole,
Croatian: Naročito molimo da obavijestite svog liječnika ako uzimate bilo što od sljedećeg: - tablete za izlučivanje vode (diuretici tiazidnog tipa) - lijekove koji sprječavaju stvaranje krvnih ugrušaka poput varfarina - lijekove za liječenje epilepsije kao što su karbamazepin, fenitoin, fenobarbital - lijekove za liječenje gljivičnih infekcija poput ketokonazola, itrakonazola, vorikonazola,