FrancophonIA/ELRC3.0 huggingface dataset:
English: At high doses and after prolonged utilization, brain function impairment can occur.
Slovenian: Visoki odmerki in podaljšano jemanje lahko privedejo do motenj delovanja možganov.
English: OTHER SPECIAL WARNING (S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično.
English: In addition, because of tissue accumulation, mitotane plasma levels should be monitored regularly (e.g. monthly) once the maintenance dose has been reached.
Slovenian: Poleg tega je treba zaradi kopičenja v tkivih koncentracijo mitotana v plazmi redno meriti (npr. enkrat mesečno) po tem, ko je bil vzdrževalni odmerek dosežen.
English: It should be taken into account that dose adjustments do not produce immediate changes in plasma levels of mitotane (see section 4.4).
Slovenian: Upoštevati je treba, da prilagoditve nimajo takojšnjega vpliva na koncentracijo mitotana v plazmi (glejte poglavje 4.4).
English: Elevated liver enzymes Plasma cholesterol increased
Slovenian: Zvišane vrednosti jetrnih encimov Zvišane vrednosti plazemskega holesterola
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.
Slovenian: Plazemske koncentracije mitotana je treba nadzorovati enako kot pri odraslih, posebna pozornost pa je potrebna, ko plazemske koncentracije dosežejo 10 mg/l, saj lahko pride do hitrega povečanja plazemske koncentracije.
English: Because of its lipophilic nature, mitotane is not likely to be dialysable.
Slovenian: Mitotan se zaradi svoje lipofilne narave verjetno ne dializira.
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.
Slovenian: Spremljanje plazemskih koncentracij: Koncentracijo mitotana v plazmi je treba nadzorovati, da se prilagodi odmerek mitotana, zlasti če se zdravljenje začenja z večjimi odmerki.
English: Mitotane tissue accumulation: Fat tissue can act as a reservoir for mitotane, resulting in a prolonged half-life and potential accumulation of mitotane.
Slovenian: Kopičenje mitotana v tkivih: Maščobno tkivo lahko deluje kot zbiralnik mitotana, zaradi česar se podaljša razpolovni čas in poveča možnost kopičenja mitotana.
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
Slovenian: - rifabutin ali rifampicin, ki se uporabljata za zdravljenje tuberkuloze; - grizeofulvin, ki se uporablja za zdravljenje glivičnih okužb; - zeliščni pripravki, ki vsebujejo šentjanževko (Hypericum perforatum);
English: Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi za citotoksična zdravila.
English: Regular monitoring (e.g. every two months) of mitotane plasma levels is also necessary after interruption of treatment.
Slovenian: Redno spremljanje (npr. vsaka dva meseca) plazemske koncentracije mitotana je nujno tudi po prekinitvi zdravljenja.
English: Monitoring of mitotane plasma levels is specially recommended in these patients (see section 4.4).
Slovenian: Za te bolnike še posebej priporočamo spremljanje plazemskih koncentracij mitotana (glejte poglavje 4.4).
English: What Lysodren looks like and contents of the pack
Slovenian: Izgled zdravila Lysodren in vsebina pakiranja
English: Special populations
Slovenian: Posebne populacije bolnikov
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serij
English: You should tell your doctor if any of the following applies to you: - if you have an injury (shock, severe trauma), an infection or if you have any illness while you are taking Lysodren.
Slovenian: Zdravniku morate povedati, če karkoli od naslednjega velja za vas: - če se med jemanjem zdravila Lysodren poškodujete (šok, huda poškodba), če dobite okužbo, ali če imate kakršnokoli bolezen.
English: In patients with mild to moderate hepatic impairment, caution should be exercised and monitoring of liver function should be performed.
Slovenian: Pri bolnikih z blago do zmerno okvarjenim delovanjem jeter je treba biti previden in nadzorovati je treba delovanje jeter.
English: In such cases, thyroid function should be investigated in order to identify a possible thyroid impairment linked to mitotane treatment.
Slovenian: V teh primerih je potrebno preiskati delovanje ščitnice, da se odkrije morebitne motnje delovanja ščitnice povezane z mitotanom.
English: Therefore, the plasma concentrations of the substances metabolised via cytochrome P450 may be modified.
Slovenian: Zaradi tega se lahko spremenijo plazemske koncentracije snovi, ki se presnavljajo preko citokroma P450.
English: Liver damage (hepatocellular/cholestatic /mixed)
Slovenian: (hepatocelularna/holestats ka/mešana)
English: Caution should be taken when co-prescribing active substances metabolised by this pathway such as, among others, sunitinib and midazolam.
Slovenian: Pri sočasnem predpisovanju učinkovin, ki se presnavljajo po tej poti, kot sta, med drugimi, sunitinib in midazolam, je potrebna previdnost.
English: What Lysodren is and what it is used for What you need to know before you take Lysodren How to take Lysodren
Slovenian: Kaj je zdravilo Lysodren in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Lysodren Kako jemati zdravilo Lysodren Možni neželeni učinki
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.
Slovenian: Varfarin in kumarinu podobna antikoagulacijska zdravila: Poročajo, da mitotan pospešuje presnavljanje varfarina z indukcijo mikrosomskih encimov v jetrih.
English: The use of mitotane in patients with severe hepatic impairment is not recommended.
Slovenian: Uporaba mitotana pri bolnikih s hudo ledvično okvaro ni priporočljiva.
English: Lysodren may interfere with several medicines.
Slovenian: Zdravilo Lysodren lahko vpliva na delovanje več zdravil.
English: Lysodren 500 mg tablets
Slovenian: Lysodren 500 mg tablete
English: Mitotane is an adrenal cytotoxic active substance, although it can apparently also cause adrenal inhibition without cellular destruction.
Slovenian: Mitotan je zdravilna učinkovina z nadledvičnim citotoksičnim delovanjem, čeprav ima lahko zaviralen učinek na nadledvično žlezo očitno tudi brez uničenja celic.
English: Particularly, mitotane has been shown to have an inductive effect on cytochrome 3A4.
Slovenian: Zlasti je za mitotan dokazano, da inducira citokrom 3A4.
English: Treatment with Lysodren should be continued as long as clinical benefits are observed.
Slovenian: Zdravljenje z Lysodrenom naj traja dokler so opazni blagodejni učinki zdravila.
English: Its biochemical mechanism of action is unknown.
Slovenian: Biokemijski mehanizem delovanja mitotana ni poznan.
English: Prolonged bleeding time appears a frequent finding (90 %): although the exact mechanism of such an effect is unknown and its relation with mitotane or with the underlying disease is uncertain, it should be taken into account when surgery is considered.
Slovenian: Čas krvavitve je pogosto podaljšan (90 %): povezava z mitotanom ali obstoječim bolezenskim stanjem je tudi nejasna.
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.
Slovenian: Šok, huda travma ali okužba: Ker je poglavitno delovanje mitotana supresija nadledvične žleze, je potrebno zdravljenje začasno prekiniti v primerih šoka, hude travme ali okužbe.
English: Any unused product or waste material should be disposed of in accordance with local requirements
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Balance disorders
Slovenian: Motnje ravnotežja
English: Dosing should be individually adjusted based on mitotane plasma levels monitoring and clinical tolerance until mitotane plasma levels reach the therapeutic window 14 - 20 mg/l.
Slovenian: Odmerjanje je treba prilagoditi vsakemu bolniku posebej na podlagi nadzorovanja plazemskih koncentracij mitotana in klinične tolerance, dokler plazemske koncentracije mitotana ne dosežejo območja terapevtskih koncentracij 14-20 mg/l.
English: Not Known
Slovenian: Neznana
English: The effect of Lysodren on non functional adrenal cortical carcinoma is not established
Slovenian: Učinek Lysodrena na nefunkcionalne karcinome skorje nadledvične žleze ni dognan.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Koruzni škrob
English: dichlorodiphenyl)-2,2 dichloroethene (o,p'-DDE) analogue of mitotane.
Slovenian: dikloroetena (o,p'-DDE).
English: Improvement after mitotane discontinuation has been observed.
Slovenian: Po prenehanju jemanja mitotana so opazili izboljšanje.
English: Like all medicines, Lysodren can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Caregivers should wear disposable gloves when handling the tablets.
Slovenian: skrbnikom pa, naj med rokovanjem s tabletami uporabljajo rokavice za enkratno uporabo.
English: Lysodren has a major influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Lysodren ima velik vpliv na sposobnost vožnje in upravljanja s stroji.
English: In order to find the optimal dose for you, your doctor will monitor regularly the levels of Lysodren in your blood.
Slovenian: Zdravnik bo redno spremljal ravni zdravila Lysodren v vaši krvi, da bi ugotovil optimalni odmerek za vas.
English: - The active substance is mitotane.
Slovenian: - Zdravilna učinkovina je mitotan.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(ŠTEVILKE) DOVOLJENJA(DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: Since mitotane is mainly metabolised through the liver, mitotane plasma levels are expected to increase if liver function is impaired.
Slovenian: Ker se mitotan presnavlja predvsem preko jeter, se pričakuje, da bodo plazemske koncentracije mitotana višje pri bolnikih z okvarjenim delovanjem jeter.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Lactation (see section 4.6)
Slovenian: 4.3 Kontraindikacije Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Among the latter, three studies find such an increase only in patients in whom mitotane plasma is above 14 mg/l.
Slovenian: Izmed slednjih, so tri takšen učinek dokazale le pri bolnikih s plazemskimi koncentracijami mitotana nad
English: The paediatric posology of mitotane has not been well characterised but appears equivalent to that of adults after correction for body surface.
Slovenian: Odmerjanje mitotana pri pediatričnih bolnikih ni povsem določeno, vendar se zdi, da je po prilagoditvi odmerjanja glede na telesno površino, ekvivalentno odmerjanju pri odraslih bolnikih.
English: Patients should be advised not to use any tablets showing signs of deterioration, and caregivers to wear disposable gloves when handling the tablets.
Slovenian: Bolnikom je treba svetovati, naj ne uporabljajo tablet, ki kažejo znake kvarjenja,
English: How to take Lysodren
Slovenian: Kako jemati zdravilo Lysodren
English: Mitotane was given alone or combined with chemotherapy with various agents.
Slovenian: Sodelujoči so jemali samo mitotan ali pa kombinacije mitotana z drugimi učinkovinami.
English: mg/l could suggest that patients with mitotane plasma levels ≥ 14 mg/l could have an improvement in disease control rate (62.9% versus 33.5%; p< 0.
Slovenian: Analiza bolnikov, ki so dosegli ravni mitotana ≥ 14 mg/l vsaj enkrat v 6 mesecih, v primerjavi z bolniki z ravnmi mitotana v plazmi < 14 mg/l, bi lahko dokazala, da pri bolnikih z ravnmi mitotana v plazmi ≥ 14 mg/l pride do izboljšanja deleža nadzorovane bolezni (62,9 % v primerjavi s 33,5 %; p < 0,0001).
English: Side effects may occur with certain frequencies, which are defined as follows: - very common: may affect more than 1 in 10 people - common: may affect up to 1 in 10 people - not known: frequency cannot be estimated from the available data
Slovenian: - zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov; - pogosti: pojavijo se lahko pri 1 od 10 bolnikov;
English: Muscoloskeletal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva
English: Neuro-psychological retardation may be observed during mitotane treatment.
Slovenian: V času zdravljenja z mitotanom lahko opazimo nevro-psihološko nazadovanje.
English: You must not breast-feed while taking Lysodren and even after stopping it.
Slovenian: Med jemanjem zdravila Lysodren in tudi po njem ne smete dojiti.
English: Clinical information comes mainly from a prospective trial (n= 24 patients) in children and adolescents aged at diagnosis from 5 months to 16 years (median age: 4 years) who had an unresectable primary tumour or who presented a tumour recurrence or a metastasic disease; most of the children (75%) presented with endocrine symptoms.
Slovenian: Pediatrična populacija Klinični podatki so zbrani predvsem iz velikega retrospektivnega preskušanja (n = 24 bolnikov) pri otrocih in mladostnikih, starih od 5 mesecev do 16 let (mediana starosti: 4 leta) ob postavitvi diagnoze,
English: Leucopenia (including neutropenia), anemia and thrombocytopenia have been reported frequently during mitotane treatment (see section 4.8).
Slovenian: Med zdravljenjem z mitotanom so pogosto poročali o levkopeniji (vključno z nevtropenijo), anemiji in trombocitopeniji (glejte poglavje 4.8).
English: Hypercholesterolemia Hypertriglyceridaemia
Slovenian: Hipertrigliceridemija
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.
Slovenian: Če lahko zanosite, morate med zdravljenjem z zdravilom Lysodren in tudi po njem uporabljati učinkovito kontracepcijsko metodo.
English: - if you have severe kidney problems - if you are using any medicines mentioned below (see "Other medicines and Lysodren") - if you have gynaecological problems such as bleeding and/ or pelvic pain.
Slovenian: - če uporabljate katera koli spodaj omenjena zdravila (glejte poglavje »Druga zdravila in zdravilo Lysodren«);
English: Plasma triglycerides increased
Slovenian: Zvišane vrednosti plazemskih trigliceridov
English: Mental impairment Polyneuropathy Movement disorder Dizziness Headache
Slovenian: Motnje umskih sposobnosti Polinevropatija Motnje pri gibanju Omotica
English: Tell your doctor immediately if you have taken accidentally more Lysodren than you should or if a child has accidentally swallowed some.
Slovenian: Če ste vzeli večji odmerek zdravila Lysodren, kot bi smeli Nemudoma obvestite zdravnika, če ste pomotoma zaužili večji odmerek zdravila Lysodren, kot bi smeli ali če nekaj zdravila Lysodren pogoltne otrok.
English: Lysodren 500 mg tablets mitotane
Slovenian: Lysodren 500 mg tablete mitotan
English: This medicine is used for the treatment of symptoms of advanced non operable, metastatic or recurrent malignant tumours of the adrenal glands.
Slovenian: Uporablja se za zdravljenje simptomov napredovalega metastatskega ali ponavljajočega se malignega tumorja skorje nadledvične žleze, ki ga ni mogoče kirurško odstraniti.
English: Blood uric acid decreased Blood androstenedione decreased (in females) Blood testosterone decreased (in females) Sex hormone binding globulin increased Blood free testosterone decreased (in males)
Slovenian: Znižane vrednosti androstendiona v krvi (pri ženskah) Znižane vrednosti testosterona v krvi (pri ženskah)
English: Non-malignant ovarian macrocysts (with symptoms such as pelvic pain, bleeding) have been described.
Slovenian: Ženske pred menopavzo Opisane so bile nemaligne makrociste na jajčnikih (s simptomi, kot sta medenična bolečina in krvavitev).
English: Fat-rich food: Data with various mitotane formulations suggest that administration with fat-rich food enhances absorption of mitotane.
Slovenian: Hrana, bogata z maščobami: Na podlagi podatkov o različnih pripravkih mitotana ugotavljajo, da jemanje s hrano, bogato z maščobo, pospeši absorpcijo mitotana (glejte poglavje 5.2).
English: Animal reproduction studies have not been conducted with mitotane.
Slovenian: Študije vpliva mitotana na razmnoževanje pri živalih niso bile izvedene.
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).
Slovenian: 5 mesecih, pri čemer je bil skupen odmerek mitotana v območju 283 do 387 g (mediana vrednost:
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.
Slovenian: 20 mg/l), ki zagotavlja optimalno uporabo zdravila Lysodren ob sprejemljivi varnosti.
English: Hepatotoxicity has been observed in patients treated with mitotane.
Slovenian: Pri bolnikih, zdravljenih z mitotanom, so opazili hepatotoksičnost.
English: Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Hepatic or renal impairment: There are insufficient data to support the use of mitotane in patients with severe hepatic or renal impairment.
Slovenian: Jetrna ali ledvična okvara: Pri bolnikih s hudo jetrno ali ledvično okvaro ni dovolj podatkov, s katerimi bi lahko upravičili uporabo mitotana.
English: Talk to your doctor or pharmacist before taking Lysodren.
Slovenian: Pred začetkom jemanja zdravila Lysodren se posvetujte z zdravnikom ali farmacevtom.
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.
Slovenian: Takoj obvestite zdravnika, ki se bo morda odločil začasno prekiniti zdravljenje; - če imate težave z jetri: povejte svojemu zdravniku, če med zdravljenjem z zdravilom Lysodren opazite katerega od naslednjih znakov in simptomov težav z jetri: srbenje, rumena obarvanost oči ali kože, temen urin in bolečine ali neprijeten občutek v desnem zgornjem delu trebuha.
English: HRA Pharma Rare Diseases
Slovenian: Imetnik dovoljenja za promet z zdravilom HRA Pharma Rare Diseases
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).
Slovenian: Pri bolnikih z blago ali zmerno jetrno ali ledvično okvaro je potrebna previdnost, zlasti pa je priporočeno spremljanje plazemskih koncentracij mitotana
English: Lysodren may harm the foetus.
Slovenian: Zdravilo Lysodren lahko škoduje plodu.
English: Caution should be exercised and frequent monitoring of mitotane plasma levels is especially recommended in these patients.
Slovenian: Pri teh bolnikih je treba je biti previden, predvsem pa je priporočljivo redno nadzorovati plazemske koncentracije mitotana.
English: NAME AND ADDRESS OF THE MARKETING AUTORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM HRA Pharma Rare Diseases
English: Red blood cell, white blood cell and platelet counts should be monitored during mitotane treatment.
Slovenian: Med zdravljenjem z mitotanom je treba spremljati število rdečih in belih krvničk ter trombocitov.
English: - if you are being treated with medicines containing spironolactone (see "Other medicines and
Slovenian: Med jemanjem zdravila Lysodren ne smete dojiti; - če se zdravite z zdravili, ki vsebujejo spironolakton (glejte poglavje »Druga zdravila in zdravilo
English: Hypouricaemia
Slovenian: Hipourikemija
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.emea.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju..
English: Your doctor may prescribe you some hormonal treatment (steroids) while you are taking Lysodren.
Slovenian: Zdravnik vam bo med zdravljenjem z zdravilom Lysodren morda predpisal zdravljenje s hormoni
English: Ataxia Paresthesia Vertigo Sleepiness
Slovenian: Ataksija Parestezija Vrtoglavica Zaspanost
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.
Slovenian: Izkaznica navaja, da so nagnjeni k insuficienci nadledvične žleze in da naj se v primeru nujne zdravstvene oskrbe izvedejo primerni previdnostni ukrepi.
English: The patient should be followed closely, taking into account that impairment is reversible, but given the long half-life and the lipophilic nature of mitotane, it may take weeks to return to normal.
Slovenian: vendar lahko pa zaradi dolge razpolovne dobe in lipofilne narave mitotana, traja več tednov, da se stanje normalizira.
English: Therefore, patients should be closely monitored for a change in anticoagulant dose requirements when mitotane is administered to patients on coumarin-like anticoagulants.
Slovenian: Zato je treba bolnike, ki se sočasno zdravijo z mitotanom in kumarinu podobnimi antikoagulacijskimi zdravili, skrbno spremljati zaradi morebitne spremembe odmerka antikoagulacijskega zdravila.
English: There is no experience on the use of mitotane in older patients, so data are insufficient to give a dose recommendation in this group.
Slovenian: Pri uporabi mitotana pri starejših bolnikih ni izkušenj, zato ni podatkov s katerimi bi se lahko priporočil odmerek za to skupino bolnikov.
English: Nausea
Slovenian: Bruhanje
English: Gynaecomastia
Slovenian: Ginekomastija
English: Your doctor may decide to stop treatment with Lysodren temporarily or to lower the dose if you experience certain side effects.
Slovenian: Če se pojavijo nekateri neželeni učinki, se bo zdravnik morda odločil začasno prekiniti zdravljenje z zdravilom Lysodren ali zmanjšati odmerek.