FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefits of Ocrevus have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ocrevus izkazalo v študijah?
English: What is Ocrevus and what is it used for?
Slovenian: Kaj je zdravilo Ocrevus in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Ocrevus.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The patient should be monitored during the infusion and for at least an hour afterwards, and facilities to manage severe reactions should be readily available.
Slovenian: Bolnika je treba med infundiranjem in še vsaj eno uro po tem spremljati, na voljo pa mora biti oprema za ukrepanje v primeru hudih reakcij.
English: The active substance in Ocrevus, ocrelizumab, is a monoclonal antibody designed to recognise and attach to a target called CD20 on the surface of certain types of white blood cells (so called B cells).
Slovenian: Zdravilna učinkovina v zdravilu Ocrevus, okrelizumab, je monoklonsko protitelo, ki je bilo zasnovano tako, da prepozna tarčno beljakovino, imenovano CD20, ki je prisotna na površini nekaterih vrst belih krvnih celic (t. i. celic B), in se veže nanjo.
English: What are the risks associated with Ocrevus?
Slovenian: Kakšna tveganja so povezana z zdravilom Ocrevus?
English: The European Medicines Agency concluded that the benefits seen with Ocrevus outweighed its risks and recommended that it be authorised in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Ocrevus večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: A third study, in 732 patients with primary progressive multiple sclerosis (PPMS), showed that fewer patients taking Ocrevus had worsening symptoms lasting 12 weeks or more (30%) compared with those taking a placebo (34%).
Slovenian: Tretja študija pri 732 bolnikih s primarno progresivno multiplo sklerozo (PPMS) je pokazala, da je do poslabšanja simptomov, ki je trajalo 12 tednov ali več, prišlo pri manj bolnikih, ki so jemali zdravilo Ocrevus (30 %), kot pri tistih, ki so jemali placebo (34 %).
English: Ocrevus treatment also provided some benefit in patients with primary progressive multiple sclerosis, a condition for which treatments are urgently needed.
Slovenian: Zdravljenje z zdravilom Ocrevus je nekoliko koristilo tudi bolnikom s primarno progresivno multiplo sklerozo, boleznijo, za katero so zdravila nujno potrebna.
English: In two studies of 1,656 patients with relapsing forms of multiple sclerosis (RMS), the average number of relapses in patients treated with Ocrevus was about half that in patients treated with another medicine interferon beta-1a (0.16 versus 0.29 relapses per year).
Slovenian: V dveh študijah, ki sta vključevali 1 656 bolnikov z recidivnimi oblikami multiple skleroze (RMS), je bilo povprečno število recidivov pri bolnikih, zdravljenih z zdravilom Ocrevus, enako približno polovici števila recidivov pri bolnikih, zdravljenih z drugim zdravilom, interferonom beta-1a (0,16 v primerjavi z 0,29 recidiva na leto).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ocrevus have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ocrevus upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: These white blood cells play a role in multiple sclerosis by attacking the sheaths around the nerves in the brain and spinal cord, causing inflammation and damage.
Slovenian: Te bele krvne celice sodelujejo pri multipli sklerozi tako, da napadajo ovojnice okrog živcev v možganih in hrbtenjači, s čimer povzročajo vnetje in poškodbo.
English: For more information about treatment with Ocrevus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ocrevus preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: • adults with primary progressive multiple sclerosis (PPMS), where symptoms get steadily worse over time.
Slovenian: • pri odraslih s primarno progresivno multiplo sklerozo (PPMS), pri kateri se simptomi stalno slabšajo.
English: Why is Ocrevus approved?
Slovenian: Zakaj je bilo zdravilo Ocrevus odobreno?
English: Studies have shown that Ocrevus is effective at reducing the number of relapses and it can also reduce the worsening of symptoms in some patients.
Slovenian: Študije so pokazale, da zdravilo Ocrevus učinkovito zmanjšuje število recidivov in lahko pri nekaterih bolnikih tudi upočasni slabšanje simptomov.
English: By targeting the B cells, Ocrevus helps to reduce their activity and thereby relieves symptoms or slows down the worsening of the disease.
Slovenian: Zdravilo Ocrevus z usmerjanjem na celice B pomaga zmanjševati njihovo dejavnost in s tem blaži simptome ali upočasnjuje slabšanje bolezni.
English: Ocrevus can only be obtained with a prescription and treatment must only be started and supervised by a doctor experienced in treating diseases of the nerves.
Slovenian: Predpisovanje in izdaja zdravila Ocrevus je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolezni živčevja.
English: The most important and most frequently reported side effects with Ocrevus are infusion reactions (such as itching, rash, and difficulty breathing) and infections.
Slovenian: Najpomembnejši neželeni učinki zdravila Ocrevus, o katerih so najpogosteje poročali, so reakcije na infundiranje (srbenje, izpuščaj in težave z dihanjem) in okužbe.
English: Ocrevus is a medicine for treating multiple sclerosis - an inflammatory disease of the nervous system that causes symptoms such as weakness, difficulty walking and problems with vision.
Slovenian: Zdravilo Ocrevus se uporablja za zdravljenje multiple skleroze, tj. vnetnega obolenja živčevja, ki povzroča simptome, kot so šibkost, težave s hojo in težave z vidom.
English: For practical information about using Ocrevus, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ocrevus naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: • adults with relapsing forms of multiple sclerosis (RMS), where the patient has flare-ups (relapses)
Slovenian: • pri odraslih z recidivnimi oblikami multiple skleroze (RMS), pri čemer ima bolnik poslabšanja
English: Ocrevus is given as an infusion (drip) into a vein.
Slovenian: Zdravilo Ocrevus se daje z infundiranjem (kapalno infuzijo) v veno.
English: How does Ocrevus work?
Slovenian: Kako zdravilo Ocrevus deluje?
English: For the full list of side effects reported with Ocrevus, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ocrevus, glejte navodilo za uporabo.
English: Studies showed that Ocrevus was more effective than interferon beta-1a at reducing the number of relapses in patients with relapsing forms of multiple sclerosis.
Slovenian: Študije so pokazale, da je bilo zdravilo Ocrevus pri zmanjševanju števila recidivov pri bolnikih z recidivnimi oblikami multiple skleroze učinkovitejše od interferona beta-1a.
English: How is Ocrevus used?
Slovenian: Kako se zdravilo Ocrevus uporablja?
English: Ocrevus contains the active substance ocrelizumab.
Slovenian: Zdravilo Ocrevus vsebuje zdravilno učinkovino okrelizumab.
English: Date of first authorisation: 28 April 2004 Date of last renewal: 28 April 2009
Slovenian: Datum prve odobritve: 28. april 2004 Datum zadnjega podaljšanja : 28. april 2009
English: Older patients (≥ 65 years old)
Slovenian: Starejši bolniki (≥ 65 let)
English: Safety data are based on literature (mainly retrospective studies).
Slovenian: Podatki o varnosti temeljijo na literaturi (večinoma retrospektivne študije).
English: Do not take a double dose to make up for the forgotten one.
Slovenian: Ne vzemite dvojnega odmerka, da nadomestite pozabljenega.
English: After opening: 1 year.
Slovenian: Po odprtju: 1 leto.
English: • Risk management plan (RMP)
Slovenian: Načrt za obvladovanje tveganja (RMP)
English: These symptoms may reveal complications for which specific medication could be appropriate.
Slovenian: Ti simptomi lahko razkrijejo zaplete, za katere so lahko ustrezna določena zdravila.
English: Lysodren").
Slovenian: Lysorden«).
English: Other effects should be treated symptomatically.
Slovenian: Drugi učinki se zdravijo simptomatično.
English: Treatment should be initiated and followed by a suitably experienced specialist.
Slovenian: Zdravljenje naj uvede in spremlja primerno izkušen zdravnik.
English: EXP After opening: 1 year
Slovenian: EXP: Po odprtju: 1 leto.
English: Nervous system undesirable effects occur in approximately 40 % of patients.
Slovenian: Neželeni učinki na živčevje se pojavijo pri približno 40 % bolnikov.
English: Leucopoenia has been reported in 8 to 12 % of patients.
Slovenian: O levkopeniji so poročali pri 8 do 12 % bolnikov.
English: France Tel: + 33 1 40 33 93 14
Slovenian: Tel: + 33 1 40 33 93 14 Izdelovalec
English: There were recurrences in 40% of children; the survival rate at 5 years was 49%.
Slovenian: Bolezen se je ponovno pojavila pri 40 % otrok, petletno preživetje je bilo 49 %.
English: The target plasma concentration is usually reached within a period of 3 to 5 months.
Slovenian: Ciljna plazemska koncentracija se ponavadi doseže v 3 do 5 mesecih.
English: Tablet.
Slovenian: Tablete.
English: Hypothyroidism and growth retardation may be also observed.
Slovenian: Opaziti je mogoče tudi hipotiroidizem in zaostalost v rasti.
English: UNIQUE IDENTIFIER - 2D BARCODE
Slovenian: ENOLIČNA IDENTIFIKACIJSKA OZNAKA - 2D ČRTNA KODA
English: More than 80 % of patients treated with mitotane have shown at least one type of undesirable effect.
Slovenian: Več kot 80 % bolnikov zdravljenih z mitotanom je imelo vsaj eno vrsto neželenih učinkov.
English: For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Slovenian: Za dodatne informacije o testiranju vzorcev se obrnite na imetnika dovoljenja za promet z zdravilom ali njegovega lokalnega predstavnika (glejte poglavje 7).
English: However, this result should be cautiously taken since the examination of the mitotane effects was not the primary endpoint of the study.
Slovenian: Vendar je treba ta rezultat obravnavati previdno, saj raziskovanje učinkov mitotana ni bil primarni opazovani dogodek v študiji.
English: Mitotane has not been studied in a comprehensive clinical development program.
Slovenian: Mitotana niso preučevali v obsežnem programu kliničnega razvoja.
English: They are bisected on one side and impressed "BL" over "L1" on the other side.
Slovenian: Na eni strani imajo zarezo, na drugi pa vtisnjen napis »BL« nad »L1«.
English: 2.800 04010 Sermoneta (Latina) Italy or
Slovenian: 04010 Sermoneta (Latina) Italija ali
English: Therefore, steroid replacement may be necessary in these patients.
Slovenian: Pri teh bolnikih bo morda potrebna nadomestitev steroidov.
English: Frequency Not Known
Slovenian: Pogostnost ni znana
English: Ambulatory patients should be warned not to drive or use machines.
Slovenian: Bolnike, ki se zdravijo ambulantno, je treba opozoriti, naj ne vozijo in ne upravljajo strojev.
English: Autoimmune hepatitis has been reported in 7 % of patients with no other information on mechanism.
Slovenian: O avtoimunskem hepatitisu so poročali pri 7 % bolnikov brez dodatnih podatkov o mehanizmu.
English: Microcrystalline cellulose (E 460) Macrogol 3350
Slovenian: Mikrokristalna celuloza (E 460) Makrogol 3350
English: Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Table 1: Frequency of adverse reactions identified from literature data
Slovenian: Tabela 1: Pogostnost neželenih reakcij, navedenih v podatkih iz literature Neželena reakcija
English: Some of these effects (anorexia) may constitute the hallmark of initial central nervous system impairment.
Slovenian: Nekateri učinki (anoreksija) predstavljajo začetne znake motenj centralnega živčnega sistema.
English: Skin rashes which have been reported in 5 to 25 % of patients do not seem to be dose related.
Slovenian: Videti je, da izpuščaji na koži, o katerih so poročali pri 5 do 25 % bolnikov, niso odvisni od odmerka.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: ENOLIČNA IDENTIFIKACIJSKA OZNAKA - ČLOVEKU BERLJIVI PODATKI
English: Paediatric patients
Slovenian: Pediatrični bolniki
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Animal studies with similar substances have shown reproductive toxicity (see section 5.3).
Slovenian: V študijah na živalih s podobnimi snovmi so odkrili reproduktivno toksičnost (glejte poglavje 5.3).
English: If no clinical benefits are observed after 3 months at optimal dose, treatment should be permanently discontinued.
Slovenian: Če kliničnih koristi ni opaziti po 3 mesecih optimalnega odmerjanja, je treba z zdravljenjem trajno prekiniti.
English: Overall, the disease-free interval was 7 months (2 to 16 months).
Slovenian: V povprečju je bil čas brez bolezni 7 mesecev (2 do 16
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX23
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX23
English: Therefore, you should tell your doctor if you are using medicines containing any of the following active substances: - warfarin or other anticoagulants (blood thinners), used to prevent blood clots.
Slovenian: Zato morate povedati zdravniku, če uporabljate zdravila, ki vsebujejo katerekoli izmed naslednjih zdravilnih učinkovin: - varfarin in drugi antikoagulanti (zdravila za redčenje krvi), ki se uporabljajo za preprečevanje krvnih strdkov.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: Gastrointestinal disorders are the most frequently reported (10 to 100 % of patients) and are reversible when the dose is reduced.
Slovenian: Bolezni prebavil so najpogosteje poročane (pri 10 do 100 % bolnikov) in so reverzibilne, ko se odmerek zmanjša.
English: This should be taken into account when interpreting the results of hormonal assays and may result in gynaecomastia.
Slovenian: To je treba upoštevati pri interpretaciji rezultatov hormonskih preiskav, lahko pa tudi povzroči ginekomastijo.
English: Dose adjustments, monitoring and discontinuation
Slovenian: Prilagajanje, nadzorovanje in prekinitev odmerjanja
English: Tel: + 33 1 40 33 93 14 medinfo-rd@hra-pharma.com
Slovenian: HRA Pharma Rare Diseases Tel: + 33 1 40 33 93 14 medinfo-rd@hra-pharma.com
English: Opportunistic mycosis
Slovenian: Oportunistična mikoza
English: After intravenous administration, 25% of the dose was excreted as metabolites within 24 hours.
Slovenian: Po intravenskem dajanju se 25 % odmerka izloči v obliki presnovkov v 24 urah.
English: You can divide the total daily dose in two or three intakes.
Slovenian: Skupni dnevni odmerek lahko razdelite v dva ali tri odmerke.
English: Consequently, despite a constant dose, mitotane levels may increase.
Slovenian: Posledično se kljub stalnemu odmerku koncentracija mitotana lahko zviša.
English: Mitotane plasma levels higher than 20 mg/l may be associated with severe undesirable effects and offer no further benefit in terms of efficacy.
Slovenian: Plazemske koncentracije mitotana višje od 20 mg/l so mogoče povezane s hudimi neželenimi učinki in ne prinašajo koristi v smislu učinkovitosti.
English: The activity of liver enzymes (gamma-GT, aminotransferase, alkaline phosphatase) is commonly increased.
Slovenian: Aktivnosti jetrnih encimov (gama-GT, aminotransferaza, alkalna fosfataza) so običajno povečane.
English: A case of cholestatic hepatitis has been reported.
Slovenian: Poročali so o primeru holestatskega hepatitisa.
English: The experience in patients in this age group is very limited.
Slovenian: Izkušenj z bolniki v tej starostni skupini je malo.
English: After six months mitotane plasma levels were undetectable and the patient recovered clinically.
Slovenian: Po šestih mesecih ravni mitotana v plazmi ni bilo mogoče zaznati in bolnik je klinično okreval.
English: Mitotane apparently causes increased formation of 6-betahydroxy cholesterol.
Slovenian: Očitno mitotan povzroči povečano tvorbo 6-beta-hidroksiholesterola.
English: Because of an increased risk of acute adrenocortical insufficiency, patients should be instructed to contact their physician immediately if injury, infection, or any other concomitant illness occurs.
Slovenian: Zaradi povečanega tveganja akutne adrenokortikalne insuficience, je potrebno bolnikom svetovati, da takoj obvestijo svojega zdravnika v primerih poškodbe, okužbe ali katerekoli sočasne druge bolezni.
English: If you accidentally miss a dose, just take the next dose as scheduled.
Slovenian: Če pomotoma izpustite odmerek, vzemite naslednji odmerek po običajnem urniku.
English: The dose of your anticoagulant may need adjustment.
Slovenian: Odmerek antikoagulanta bo morda treba prilagoditi;
English: Psychiatric disorders Confusion
Slovenian: Psihiatrične motnje Zmedenost
English: INSTRUCTIONS FOR USE
Slovenian: NAVODILA ZA UPORABO
English: Paediatric patients The experience in children is limited.
Slovenian: Pediatrična populacija Izkušenj pri otrocih je malo.
English: Liver enzymes levels normalize when the mitotane dose is decreased.
Slovenian: Vrednost jetrnih encimov se normalizira, ko se odmerek mitotana zmanjša.
English: For information on the product, please contact:
Slovenian: Za informacije o zdravilu se obrnite na:
English: Liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) should be periodically monitored, especially during the first months of treatment or when it is necessary to increase the dose.
Slovenian: Redno je treba opravljati teste delovanja jeter (ravni alanin-transaminaze [ALT], aspartat-transaminaze [AST] in bilirubina), zlasti v prvih mesecih zdravljenja ali kadar je treba povečati odmerek.
English: Always keep with you the Lysodren Patient Card included at the end of this leaflet.
Slovenian: Vedno imejte pri sebi izkaznico bolnika za zdravilo Lysodren, ki je priložena na koncu tega navodila.
English: The usual starting dose for adults is 2 to 3 g (4 to 6 tablets) per day.
Slovenian: Običajni začetni odmerek za odrasle je 2 do 3 g (4 do 6 tablet) na dan.
English: The name of my Doctor is: Phone: ……………………………….
Slovenian: Tel. številka: ……………………………….
English: Risk of adrenal insufficiency: All patients with non functional tumour and 75% of patients with functional tumour show signs of adrenal insufficiency.
Slovenian: Tveganje za oslabljeno delovanje nadledvične žleze: Vsi bolniki z nefunkcionalnim tumorjem in 75 % bolnikov s funkcionalnim tumorjem kažejo znake oslabljenega delovanja nadledvične žleze.
English: Due to the prolonged half-life, significant serum concentrations may persist for weeks after cessation of therapy.
Slovenian: Zaradi podaljšanega razpolovnega časa lahko znatne koncentracije v serumu vztrajajo več tednov po koncu zdravljenja.
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).
Slovenian: Uporaba pri otrocih in mladostnikih Začetni dnevni odmerek zdravila Lysodren je 1,5 do 3,5 g/m telesne površine (zdravnik jo bo izračunal na podlagi teže in velikosti otroka).
English: Lysodren is available in plastic bottles of 100 tablets.
Slovenian: Zdravilo Lysodren je na voljo v plastičnih steklenicah s 100 tabletami.
English: There was a positive linear correlation between the cumulative dose of Lysodren and the plasma levels of mitotane.
Slovenian: Obstajala je pozitivna linearna korelacija med kumulativnim odmerkom Lysodrena in plazemskimi koncentracijami mitotana.
English: In case of mild toxicity, the dose should be reduced until the maximum tolerated dose is attained.
Slovenian: V primeru blage toksičnosti je potrebno odmerek zmanjševati, dokler se ne doseže največji prenosljivi odmerek.
English: If serious adverse reactions occur, such as neurotoxicity, treatment with mitotane may need to be temporarily interrupted.
Slovenian: Če se pojavijo resni neželeni učinki, kot npr. nevrotoksičnost, je morda potrebno začasno prekiniti zdravljenje z mitotanom.
English: Therefore, the possibility of mitotane-induced liver damage cannot be excluded.
Slovenian: Zato možnosti jetrne okvare, ki jo sproži mitotan, ni možno izključiti.
English: You must not use Lysodren with medicines containing spironolactone, often used as a diuretic for heart, liver or kidney diseases.
Slovenian: Zdravila Lysodren ne smete uporabljati skupaj z zdravili, ki vsebujejo spironolakton, ki se pogosto uporablja kot diuretik pri boleznih srca, jeter ali ledvic.
English: What Lysodren is and what it is used for
Slovenian: Kaj je zdravilo Lysodren in za kaj ga uporabljamo
English: In children and adolescents, thyroid problems, neuro-psychological, growth retardation and one case of encephalopathy have been observed.
Slovenian: Pri otrocih in mladostnikih so opazili težave s ščitnico, nevro-psihološko nazadovanje, zaostajanje v rasti in en primer encefalopatije.
English: Although no specific information on pharmacodynamic interactions in the central nervous system is available, this should be borne in mind when co-prescribing medicinal products with central nervous system depressant action.
Slovenian: Čeprav specifični podatki o farmakodinamičnih interakcijah v centralnem živčnem sistemu niso na voljo, pa je ta učinek mitotana potrebno upoštevati pri sočasnem predpisovanju zdravil, ki delujejo sedativno na osrednji živčni sistem.
English: Non-clinical data on the general toxicity of mitotane is limited.
Slovenian: Nekliničnih podatkov o splošni toksičnosti mitotana je malo.
English: If it is urgent to control Cushing's symptoms in highly symptomatic patients, higher starting doses between 4 - 6 g per day could be necessary and daily dose increased more rapidly (e.g. every week).
Slovenian: Če je nadzor simptomov Cushingovega sindroma pri zelo simptomatskih bolnikih nujen, bo morda treba uporabiti večje začetne odmerke od 4-6 g na dan in dnevni odmerek povečevati hitreje (npr.
English: No unchanged mitotane has been found in bile or in urine, where o,p'-DDA predominates, together with several of its hydroxylated metabolites.
Slovenian: V žolču ali v urinu ne najdemo nespremenjenega mitotana, prevladuje pa o,p'-DDA skupaj z več svojimi hidroksiliranimi presnovki.