FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, in both studies, in some patients, the plasma mitotane levels continued to rise despite maintenance or a decrease of the daily dose of mitotane.
Croatian: Osim toga, u nekih bolesnika, u oba ispitivanja razine mitotana u plazmi nastavljale su rasti usprkos održavanju ili smanjenju dnevne doze mitotana.
English: Dose adjustments may be necessary to achieve the desired therapeutic levels in the window between 14 - 20 mg/l and avoid specific adverse reactions (see section 4.2).
Croatian: Prilagodba doze može biti potrebna za postizanje željenih terapijskih razina u prozoru između 14 - 20 mg/l i za izbjegavanje određenih nuspojava (vidjeti dio 4.2).
English: Blood and lymphatic system disorders: All blood cells can be affected with mitotane treatment.
Croatian: Poremećaji krvi i limfnog sustava: Liječenjem mitotanom mogu biti zahvaćene sve krvne stanice.
English: Treatment with Lysodren should be continued as long as clinical benefits are observed.
Croatian: Liječenje Lysodrenom treba nastaviti dok se god primjećuje klinička korist.
English: If you forget to take Lysodren
Croatian: Ako ste zaboravili uzeti Lysodren
English: Lysodren should preferably be taken during meals containing fat-rich food such as milk, chocolate, oil.
Croatian: Lysodren s hranom i pićem Lysodren je poželjno uzimati uz obrok hrane bogate mastima kao što su mlijeko, čokolada, ulje.
English: Patients should be advised not to use any tablets showing signs of deterioration, and caregivers to wear disposable gloves when handling the tablets.
Croatian: Bolesnike treba savjetovati da ne uzimaju tablete koje pokazuju znakove oštećenja, a njegovatelje da nose rukavice za jednokratnu uporabu kada upotrebljavaju tablete.
English: The target plasma mitotane concentration (14 mg/l) was reached in all patients within 3 to 5 months and the total mitotane dose ranged between 283 and 387 g (median value: 363 g).
Croatian: Ciljna koncentracija mitotana u plazmi (14 mg/l) je dostignuta unutar 3 do 5 mjeseci u svih bolesnika, a ukupna doza mitotana je bila u granicama između 283 i 387 g (medijan: 363 g).
English: Autopsy data from patients show that mitotane is found in most tissues of the body, with fat as the primary site of storage.
Croatian: Podaci iz obdukcija na bolesnicima pokazuju da se mitotan nalazi u većini tkiva u organizmu, a masno tkivo je primarno mjesto pohrane.
English: You can divide the total daily dose in two or three intakes.
Croatian: Ukupnu dnevnu dozu možete podijeliti na dva do tri uzimanja.
English: Spironolactone: Mitotane must not be given in combination with spironolactone, since this active substance may block the action of mitotane (see section 4.3).
Croatian: Spironolakton: Mitotan se ne smije davati u kombinaciji sa spironolaktonom jer ta djelatna tvar može spriječiti djelovanje mitotana (vidjeti dio 4.3).
English: Mitotane was given alone or combined with chemotherapy with various agents.
Croatian: Mitotan je primjenjen sam ili u kombinaciji s kemoterapijom s različitim lijekovima.
English: In the absence of information on the specific P450 isoenzymes involved, caution should be taken when co-prescribing active substances metabolised by this route such as, among others, anticonvulsants, rifabutin, rifampicin, griseofulvin and St. John's wort (Hypericum perforatum).
Croatian: U odsutnosti informacija o uključenim specifičnim izoenzimima P450, s oprezom treba istovremeno propisivati djelatne tvari koje se metaboliziraju tim putem kao što su između ostalih antikonvulzivi, rifabutin, rifampicin, grizeofulvin i gospina trava (Hypericum perforatum).
English: In children and adolescents, thyroid problems, neuro-psychological, growth retardation and one case of encephalopathy have been observed.
Croatian: U djece i adolescenata su opaženi problemi sa štitnjačom, neuropsihološki zastoj, zastoj u rastu i jedan slučaj encefalopatije.
English: Available clinical information comes mainly from published data in patients with inoperable or metastatic adrenal carcinoma.
Croatian: Dostupne kliničke informacije potječu iz objavljenih podataka o bolesnicima s neoperabilnim ili metastatskim karcinomom nadbubrežne žlijezde.
English: Dose and schedule
Croatian: Doziranje i raspored uzimanja
English: EU/1/04/273/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/273/001
English: Metabolism studies in man have identified the corresponding acid, 1,1-(o,p'-dichlorodiphenyl) acetic acid (o,p'-DDA), as the major circulating metabolite, together with smaller quantities of the 1,1-(o,p'
Croatian: Ispitivanja metabolizma u čovjeka otkrila su odgovarajuću kiselinu, 1,1-(o,p'-diklordifenil) acetatnu kiselinu (o,p'-DDA), kao glavni cirkulirajući metabolit zajedno s manjim količinama analoga mitotana 1,1-(o,p'-diklordifenil)-2,2 dikloreten (o,p'-DDE).
English: Central nervous system disorders: Long-term continuous administration of high doses of mitotane may lead to reversible brain damage and impairment of function.
Croatian: Poremećaji središnjeg živčanog sustava: Dugotrajna neprekinuta primjena visokih doza mitotana može voditi reverzibilnom oštećenju i poremećaju funkcije mozga.
English: To be handled only by patients, or caregivers wearing gloves.
Croatian: Lijekom smiju rukovati samo bolesnici ili njegovatelji koji nose rukavice.
English: Gastrointestinal disorders are the most frequently reported (10 to 100 % of patients) and are reversible when the dose is reduced.
Croatian: Gastrointestinalni poremećaji koji su reverzibilni kada se doza smanji najčešće su opisani (10 do 100% bolesnika).
English: Maculopathy Retinal toxicity Diplopia
Croatian: Makulopatija Retinalna toksičnost Diplopija
English: Therefore, the possibility of mitotane-induced liver damage cannot be excluded.
Croatian: Stoga se mogućnost oštećenja jetre uzrokovanog mitotanom ne može isključiti.
English: Use in children and adolescents The starting daily dose of Lysodren is 1.5 to 3.5 g/m2 body surface (this will be calculated by your doctor according to the weight and the size of the child).
Croatian: Početna dnevna doza Lysodrena je 1,5 do 3,5 g/m2 površine tijela (dozu će izračunati Vaš liječnik prema tjelesnoj težini i proporcijama djeteta).
English: A case of cholestatic hepatitis has been reported.
Croatian: Opisan je slučaj kolestatskog hepatitisa.
English: Square opaque white HDPE bottle having a thread on the mouth containing 100 tablets.
Croatian: Četvrtasta, neprozirna, bijela HDPE bočica s navojem na grlu koja sadrži 100 tableta.
English: Treatment should be initiated at 1.5 to 3.5 g/m2/day in children and adolescents with the objective of reaching 4 g/m2/day.
Croatian: Liječenje u djece i adolescenata treba započeti s 1,5 do 3,5 g/m2/dnevno s ciljem dostizanja 4 g/m2/dnevno.
English: This medicine is used for the treatment of symptoms of advanced non operable, metastatic or recurrent malignant tumours of the adrenal glands.
Croatian: Ovaj lijek se koristi za liječenje simptoma uznapredovalog neoperabilnog, metastatskog ili ponavljajućeg zloćudnog tumora nadbubrežne žlijezde.
English: Bleeding time: Prolonged bleeding time has been reported in patients treated with mitotane and this should be taken into account when surgery is considered (see section 4.8).
Croatian: Vrijeme krvarenja: U bolesnika liječenih mitotanom opisivano je produženo vrijeme krvarenja i to treba uzeti u obzir kada se razmatra kirurški zahvat (vidjeti dio 4.8).
English: Available data suggest that mitotane modifies the peripheral metabolism of steroids and that it also directly suppresses the adrenal cortex.
Croatian: Dostupni podaci ukazuju da mitotan mijenja periferni metabolizam steroidnih hormona i također direktno suprimira koru nadbubrežne žlijezde.
English: Lysodren has a major influence on your ability to drive and use machines.
Croatian: Lysodren ima značajan utjecaj na Vašu sposobnost upravljanja vozilima i strojevima.
English: There was a positive linear correlation between the cumulative dose of Lysodren and the plasma levels of mitotane.
Croatian: Postojao je pozitivan linearni međusobni odnos između ukupne doze Lysodrena i razina mitotana u plazmi.
English: Fat-rich food: Data with various mitotane formulations suggest that administration with fat-rich food enhances absorption of mitotane.
Croatian: Hrana bogata mastima: Podaci sa različitim formulacijama mitotana upućuju da primjena s hranom bogatom mastima pojačava apsorpciju mitotana.
English: Mitotane plasma levels should therefore be monitored in order to adjust the Lysodren dose and to avoid reaching toxic levels.
Croatian: Stoga je razine mitotana u plazmi potrebno kontrolirati u svrhu prilagodbe doze Lysodrena i izbjegavanja dostizanja toksičnih razina.
English: Cases of liver damage (hepatocellular, cholestatic and mixed) and autoimmune hepatitis were observed.
Croatian: Uočeni su slučajevi oštećenja jetre (hepatocelularna, kolestatska i mješovita) i autoimunog hepatitisa.
English: Lysodren (Braille applies only to outer carton)
Croatian: PODACI NA BRAILLEOVOM PISMU Lysodren (Braille se navodi samo na kutiji)
English: Hormone binding protein: Mitotane has been shown to increase plasma levels of hormone binding proteins (e.g. sex hormone-binding globulin (SHBG) and corticosteroid-binding globulin (CBG).
Croatian: Protein koji veže hormone: Dokazano je da mitotan povisuje razinu proteina u plazmi koji vežu hormone (npr. globulina koji veže spolne hormone (SBGH) i globulina koji veže kortikosteroide (CBG)).
English: Women of childbearing potential: Women of childbearing potential must use effective contraception during treatment with mitotane (see section 4.6).
Croatian: Žene reproduktivne dobi: Žene reproduktivne dobi moraju koristiti djelotvornu kontracepciju tijekom liječenja mitotanom (vidjeti dio 4.6).
English: In addition, mitotane induces a state of adrenal insufficiency which leads to the disappearance of Cushing syndrome in patients with secreting adrenal carcinoma and necessitates substitution hormonotherapy.
Croatian: Dodatno, mitotan potiče insuficijenciju nadbubrežne žlijezde, što vodi nestanku Cushingovog sindroma u bolesnika sa sekretornim karcinomom nadbubrežne žlijezde i potrebe za nadomjesnim liječenjem hormonima.
English: Improvement after mitotane discontinuation has been observed.
Croatian: Uočeno je poboljšanje nakon prekida uzimanja mitotana.
English: The effect of Lysodren on non functional adrenal cortical carcinoma is not established
Croatian: Učinak Lysodrena na nefunkcionalne karcinome kore nadbubrežne žlijezde nije utvrđen.
English: OTHER SPECIAL WARNING (S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksično.
English: Other undesirable central nervous effects have been reported in literature such as memory defects, aggressiveness, central vestibular syndrome, dysarthria, or Parkinson syndrome.
Croatian: U literaturi su opisane druge nuspojave od strane središnjeg živčanog sustava kao što su gubitak pamćenja, agresivnost, središnji vestibularni sindrom, dizartrija ili Parkinsonov sindrom.
English: Lysodren may harm the foetus.
Croatian: Lysodren može naškoditi fetusu.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.emea.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Exogenous steroids should be administered in such circumstances, since the depressed adrenal gland may not immediately start to secrete steroids.
Croatian: U tim okolnostima treba primijeniti egzogene steroidne hormone jer suprimirana nadbubrežna žlijezda ne mora odmah započeti sekreciju steroidnih hormona.
English: It should be taken into account that dose adjustments do not produce immediate changes in plasma levels of mitotane (see section 4.4).
Croatian: Treba uzeti u obzir da prilagodba doze ne izaziva neposredne promjene razina mitotana u plazmi (vidjeti dio 4.4).
English: Substances metabolised through cytochrome P450 and particularly cytochrome 3A4: Mitotane is a hepatic enzyme inducer and it should be used with caution in case of concomitant use of medicinal products influenced by hepatic metabolism (see section 4.5).
Croatian: Tvari koje se metaboliziraju putem citokroma P450 i osobito putem citokroma 3A4: Mitotan je induktor enzima jetre i treba se koristiti s oprezom u slučaju istovremene primjene s lijekovima na koje utječe metabolizam jetre (vidjeti dio 4.5).
English: The paediatric posology of mitotane has not been well characterised but appears equivalent to that of adults after correction for body surface.
Croatian: Doziranje mitotana u pedijatriji nije točno određeno no čini se jednakim kao u odraslih uz prilagođavanje prema tjelesnoj površini.
English: In a study performed in 8 patients with adrenal carcinoma treated with 2 to 3 g daily of mitotane, a highly significant correlation was found between plasma mitotane concentration and the total mitotane dose.
Croatian: U ispitivanju provedenom na 8 bolesnika s karcinomom nadbubrežne žlijezde liječenih s 2 do 3 g mitotana dnevno utvrđen je vrlo značajan međusobni odnos između koncentracije mitotana u plazmi i ukupne doze mitotana.
English: The administration of mitotane alters the extra-adrenal metabolism of cortisol in humans, leading to a reduction in measurable 17-hydroxy corticosteroids, even though plasma levels of corticosteroids do not fall.
Croatian: Primjena mitotana u ljudi mijenja metabolizam kortizola izvan nadbubrežne žlijezde dovodeći do smanjenja mjerljivih 17-hidroksi kortikosteroida čak i kada se razine kortikosteroida u plazmi ne snizuju.
English: What you need to know before you take Lysodren Do not take Lysodren
Croatian: Što morate znati prije nego počnete uzimati Lysodren
English: Dose adjustment is aimed to reach a therapeutic window (mitotane plasma levels 14 - 20 mg/l) which ensures optimal use of Lysodren with acceptable safety.
Croatian: Cilj prilagođavanja doze je dostizanje terapijskog prozora (razina mitotana u plazmi 14 - 20 mg/l) što osigurava najpovoljniju uporabu Lysodrena uz prihvatljivu sigurnost.
English: - The other ingredients are maize starch, microcrystalline cellulose (E 460), macrogol 3350 and silica colloidal anhydrous.
Croatian: Drugi sastojci su: kukuruzni škrob, mikrokristalična celuloza (E 460), makrogol 3350 i bezvodni, koloidni silicijev dioksid.
English: Shock, severe trauma or infection: Mitotane should be temporarily discontinued immediately following shock, severe trauma or infection, since adrenal suppression is its prime action.
Croatian: Šok, teška ozljeda ili infekcija: Primjena mitotana treba biti prolazno prekinuta odmah kod razvoja šoka, teške ozljede ili infekcije jer primarno djeluje supresijom nadbubrežne žlijezde.
English: Monitoring of plasma levels: Mitotane plasma levels should be monitored in order to adjust the mitotane dose, particularly if high starting doses are considered necessary.
Croatian: Kontrola razina u plazmi: Razine mitotana u plazmi treba kontrolirati zbog prilagodbe doze mitotana, osobito ako je procijenjeno da su potrebne više početne doze.
English: Elevated liver enzymes Plasma cholesterol increased
Croatian: Povišenje jetrenih enzima Povišenje kolesterola u plazmi
English: Warfarin and coumarin-like anticoagulants: Mitotane has been reported to accelerate the metabolism of warfarin through hepatic microsomal enzyme induction, leading to an increase in dose requirements for warfarin.
Croatian: Varfarin i kumarinu slični antikoagulansi: Opisano je da mitotan ubrzava metabolizam varfarina indukcijom mikrosomalnih enzima jetre dovodeći do potrebe za povišenjem doze varfarina.
English: Following discontinuation of mitotane treatment, it is slowly released from storage sites in fat, leading to reported terminal plasma half-lives ranging from 18 to 159 days.
Croatian: Nakon prekida liječenja, mitotan se polako otpušta iz mjesta pohrane u masnom tkivu vodeći do opisanog poluvijeka u plazmi u rasponu od 18 do 159 dana.
English: Treatment in adults should be started with 2 - 3 g mitotane per day and increased progressively (e.g. at two-week intervals) until mitotane plasma levels reach the therapeutic window 14 - 20 mg/l.
Croatian: Liječenje odraslih je potrebno započeti s 2 - 3 g mitotana dnevno i postupno povećavati (npr. u razmacima od dva tjedna) dok razina mitotana u plazmi ne dostigne terapijski prozor od 14 - 20 mg/l.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Before the initiation of the treatment: Large metastatic masses should be surgically removed as far as possible before starting mitotane treatment, in order to minimise the risk of infarction and haemorrhage in the tumour due to a rapid cytotoxic effect of mitotane.
Croatian: Prije početka liječenja: Prije početka liječenja mitotanom kirurški je potrebno ukloniti velike metastatske mase u što većem obimu kako bi se smanjio rizik infarkta i krvarenja u tumor zbog brzog citotoksičnog učinka mitotana.
English: Medicinal products active on central nervous system: Mitotane can cause central nervous system undesirable effects at high concentrations (see section 4.8).
Croatian: Lijekovi s djelovanjem na središnji živčani sustav: U visokim koncentracijama mitotan uzrokuje neželjena djelovanja na središnji živčani sustav (vidjeti dio 4.8).
English: Caution and close monitoring of mitotane plasma levels are highly recommended when treating overweight patients.
Croatian: Oprez i pažljivo kontroliranje razina mitotana u plazmi osobito se preporučuje tijekom liječenja bolesnika prekomjerne tjelesne težine.
English: Adverse reactions listed below are classified according to frequency and system organ class.
Croatian: Niže prikazane nuspojave klasificirane su po učestalosti i organskim sustavima.
English: Mitotane plasma levels should be monitored as for adults, with particular attention when plasma levels reach 10 mg/l as a quick increase in plasma levels may be observed.
Croatian: Razine mitotana u plazmi treba kontrolirati kao u odraslih, osobito pažljivo kada se dostigne razina u plazmi od 10 mg/l jer može biti primijećen brzi rast razina u plazmi.
English: If you may become pregnant, you should use an effective contraception during treatment with Lysodren and even after stopping it, ask your doctor for advice.
Croatian: Ako možete zatrudnjeti, morate koristiti djelotvornu kontracepciju tijekom te čak i nakon prekida liječenja Lysodrenom.
English: White, biconvex, round, scored tablets.
Croatian: Bijele, bikonveksne, okrugle tablete s razdjelnom crtom.
English: Premenopausal women: Ovarian macrocysts have been observed with higher incidence in this population.
Croatian: Žene u predmenopauzi: U toj je populaciji uočena veća incidencija makrocista na jajnicima.
English: Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (ACC).
Croatian: Simptomatsko liječenje uznapredovalog (neresektabilnog, metastatskog ili relapsa) karcinoma kore nadbubrežne žlijezde.
English: - -if you have liver problems: Tell your doctor if you develop any of the following signs and symptoms of liver problems during Lysodren treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area.
Croatian: - ako imate problema s jetrom: Obavijestite svog liječnika ako tijekom liječenja Lysodrenom primijetite bilo koji od navedenih znakova i simptoma problema s jetrom: svrbež, žutilo očiju ili kože, tamna mokraća i bol ili nelagoda u gornjem desnom dijelu trbuha.
English: Lysodren is an antitumoral medicine.
Croatian: Lysodren je protutumorski lijek.
English: Mitotane tissue accumulation: Fat tissue can act as a reservoir for mitotane, resulting in a prolonged half-life and potential accumulation of mitotane.
Croatian: Nakupljanje mitotana u tkivima: Masno tkivo može djelovati kao spremnik mitotana rezultirajući produljenim poluvijekom i mogućim nakupljanjem mitotana.
English: The use of mitotane in patients with severe renal impairment is not recommended and, in cases of mild to moderate renal impairment, caution should be exercised.
Croatian: U bolesnika s teškim oštećenjem bubrega uporaba mitotana se ne preporučuje, a u slučajevima blagog do umjerenog oštećenja bubrega potreban je oprez.
English: In patients with mild or moderate hepatic or renal impairment, caution should be exercised and monitoring of mitotane plasma levels is particularly recommended (see section 4.2).
Croatian: U bolesnika s blagim ili umjerenim oštećenjem jetre ili bubrega potreban je oprez te se osobito preporučuju kontrole razina mitotana u plazmi (vidjeti dio 4.2).
English: - antiepileptics - rifabutin or rifampicin, used to treat tuberculosis - griseofulvin, used in the treatment of fungal infections - herbal preparations containing St. John's wort (Hypericum perforatum) - Sunitinib: to treat cancer
Croatian: Moguća je prilagodba doze Vašeg antikoagulansa. - antiepileptici - rifabutin ili rifampicin, koji se koriste za liječenje tuberkuloze - griseofulvin, koji se koristi za liječenje gljivičnih infekcija - biljni pripravci koji sadrže gospinu travu (Hypericum perforatum) - sunitinib za liječenje raka
English: Mitotane plasma levels should be assessed after each dose adjustment and at frequent intervals (e.g. every two weeks), until the optimal maintenance dose is reached.
Croatian: Razine mitotana u plazmi moraju se odrediti nakon svake prilagodbe doze i u čestim razmacima (npr. svaka dva tjedna) sve do dostizanja najpovoljnije doze održavanja.
English: Lysodren 500 mg tablets
Croatian: Lysodren 500 mg tablete
English: Serious undesirable effects appear linked to the cumulative exposure to mitotane and are most likely to occur when mitotane plasma levels are at 20 mg/l or above.
Croatian: Ozbiljne nuspojave čine se povezanim s kumulativnim izlaganjem mitotanu i najvjerojatnije se događaju kada su razine mitotana u plazmi 20mg/l ili više.
English: Nervous system undesirable effects appear reversible after cessation of mitotane treatment and decrease in plasma levels (see section 4.4).
Croatian: Nuspojave od strane živčanog sustava čine se reverzibilnim nakon prekida liječenja i sniženja razina mitotana u plazmi (vidjeti dio 4.4).
English: Particularly, mitotane has been shown to have an inductive effect on cytochrome 3A4.
Croatian: Osobito, pokazalo se da je mitotan induktor citokroma 3A4.
English: Isolated cases of complicated cysts have been reported (adnexal torsion and haemorrhagic cyst rupture).
Croatian: Zabilježena je pojava izoliranih slučajeva kompliciranih cista (torzija adneksa i prsnuće hemoragične ciste).
English: Patients should carry with them the Lysodren Patient Card provided with the package leaflet indicating that they are prone to adrenal insufficiency and that, in case of emergency care, adequate precautionary measures should be taken.
Croatian: Bolesnici moraju sa sobom nositi Lysodren karticu za bolesnika priloženu uz Uputu o lijeku koja upućuje na njihovu sklonost insuficijenciji nadbubrežne žlijezde i potrebu primjene odgovarajućih mjera opreza u slučaju hitnog liječenja.
English: Lysodren may interfere with several medicines.
Croatian: Lysodren može utjecati na druge lijekove.
English: Since mitotane increases plasma levels of steroid binding proteins, free cortisol and corticotropin (ACTH) determinations are necessary for optimal dosing of steroid substitution (see section 4.8).
Croatian: Kako mitotan povisuje u plazmi razine proteina koji vežu steroidne hormone, za najpovoljnije doziranje nadomjestka steroidnih hormona potrebno je odrediti slobodni kortizol i kortikotropin (ACTH) (vidjeti dio 4.8).
English: Lysodren has a major influence on the ability to drive and use machines.
Croatian: Lysodren značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Paediatric patients: In children and adolescents, neuro-psychological retardation can be observed during mitotane treatment.
Croatian: Pedijatrijska populacija: Tijekom liječenja mitotanom u djece i adolescenata se može primjetiti neuropsihološka retardacija.