FrancophonIA/ELRC3.0 huggingface dataset:
English: Lysodren should preferably be taken during meals containing fat-rich food such as milk, chocolate, oil.
Slovenian: Zdravilo Lysodren je po možnosti treba jemati med obroki, ki vsebujejo hrano, bogato z maščobami, kot so mleko, čokolada ali olje.
English: Blood and lymphatic system disorders: All blood cells can be affected with mitotane treatment.
Slovenian: Bolezni krvi in limfatičnega sistema: Zdravljenje z mitotanom lahko vpliva na vse krvne celice.
English: Dose may be reduced after 2 or 3 months according to the mitotane plasma levels or in case of serious toxicity.
Slovenian: Odmerek se lahko zmanjša po 2 ali 3 mesecih, glede na plazemske koncentracije mitotana, ali če se pojavi resna toksičnost.
English: Square opaque white HDPE bottle having a thread on the mouth containing 100 tablets.
Slovenian: Kvadratna neprozorna bela plastenka iz HDPE z navojem na ustju, ki vsebuje 100 tablet.
English: Lysodren should be given to pregnant women only if clearly needed and if the clinical benefit clearly outweighs any potential risk to the foetus.
Slovenian: Lysodren naj se daje nosečnicam le, kadar je to brez dvoma potrebno in kadar klinične koristi pretehtajo potencialna tveganja za plod.
English: To be handled only by patients, or caregivers wearing gloves.
Slovenian: Z zdravilom smejo rokovati le bolniki ali skrbniki, ki nosijo rokavice.
English: In two of the 3 patients, plasma levels of more than 14 mg/l were achieved within 15 days and in one of them levels above 20 mg/l were achieved within approximately 30 days.
Slovenian: Pri dveh od treh bolnikov, je bila plazemska koncentracija 14 mg/l dosežena v 15 dneh in pri enem je bila koncentracija nad 20 mg/l dosežena po približno 30 dneh.
English: For induction with cytochrome P450, see section 4.5.
Slovenian: P450 glejte poglavje 4.5.
English: Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (ACC).
Slovenian: Simptomatsko zdravljenje napredovalega (neizrezljivega, metastatskega ali relapsiranega) karcinoma skorje nadledvične žleze (ACC- adrenal cortical carcinoma).
English: Tablets should be taken with a glass of water during meals containing fat-rich food (see section 4.5).
Slovenian: Tablete je treba zaužiti s kozarcem vode in med obroki, ki vsebujejo hrano, bogato z maščobami (glejte poglavje 4.5).
English: 76-78, avenue du Midi
Slovenian: CENTRE SPECIALITES PHARMACEUTIQUES 76-78, avenue du Midi
English: Women should be urged to seek medical advice if they experience gynaecological symptoms such as bleeding and/or pelvic pain.
Slovenian: Ženskam je treba svetovati, naj v primeru ginekoloških simptomov, kot je krvavitev in/ali medenična bolečina, poiščejo zdravniško pomoč.
English: Ask your doctor for advice.
Slovenian: Posvetujte se z zdravnikom.
English: Your doctor may start treatment at higher doses such as 4 to 6 g (8 to 12 tablets).
Slovenian: Zdravnik bo morda začel zdravljenje z večjim odmerkom, na primer 4 do 6 g (8 do 12 tablet).
English: Anorexia
Slovenian: Anoreksija
English: Lysodren is an antitumoral medicine.
Slovenian: Zdravilo Lysodren je protitumorsko zdravilo.
English: Autopsy data from patients show that mitotane is found in most tissues of the body, with fat as the primary site of storage.
Slovenian: S pomočjo obdukcijskih podatkov bolnikov je bilo ugotovljeno, da se mitotan nahaja v večini tkiv v telesu, poglavitno mesto nalaganja pa so maščobna tkiva.
English: You should swallow the tablets with a glass of water during meals containing fat-rich food.
Slovenian: Tablete morate pogoltniti s kozarcem vode, med obroki, ki vsebujejo hrano, bogato z maščobami.
English: In terms of overall survival, four studies conclude that mitotane treatment does not increase the survival rate whereas five find an increase in the survival rate.
Slovenian: Štiri študije mitotana so zaključile, da zdravljenje z mitotanom ne poveča stopnje preživetja, pet študij pa je dokazalo, da mitotan poveča stopnjo preživetja.
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.
Slovenian: Pri otrocih in mladostnikih je treba zdravljenje začeti z odmerkom 1,5 do 3,5 g/m2/dan z namenom doseči 4 g/m2/dan.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Leucopoenia Bleeding time prolonged
Slovenian: Levkopenija Podaljšano trajanje krvavitve
English: The prolonged elimination of mitotane from the body after discontinuation of Lysodren should be considered.
Slovenian: Upoštevati je potrebno podaljšano izločanje mitotana iz telesa po prekinitvi jemanja Lysodrena.
English: The total daily dose may be divided in two or three doses according to patient's convenience.
Slovenian: Skupni dnevni odmerek je treba razdeliti v dva ali tri odmerke, kakor je primerno za bolnika.
English: Lysodren (Braille applies only to outer carton)
Slovenian: Lysodren (Napis v Braillovi pisavi je samo na zunanji škatli)
English: The genotoxic and carcinogenic potential of mitotane has not been investigated.
Slovenian: Genotoksičnost in kancerogeni potencial mitotana nista raziskana.
English: There are some data suggesting that mitotane plasma above 14 mg/l may result in enhanced efficacy (see section 5.1).
Slovenian: Nekateri podatki so pokazali, da lahko koncentracije mitotana v plazmi nad 14 mg/l okrepijo učinkovitost (glejte poglavje 5.1).
English: Dose and schedule
Slovenian: Odmerek in razpored odmerjanja
English: Central nervous system disorders: Long-term continuous administration of high doses of mitotane may lead to reversible brain damage and impairment of function.
Slovenian: Motnje osrednjega živčnega sistema: Dolgotrajno neprekinjeno dajanje visokih odmerkov mitotana lahko povzroči reverzibilne poškodbe možganov in motnje delovanja.
English: Other undesirable central nervous effects have been reported in literature such as memory defects, aggressiveness, central vestibular syndrome, dysarthria, or Parkinson syndrome.
Slovenian: Drugi neželeni učinki na osrednji živčni sistem poročani v literaturi so na primer motnje spomina, nasilnost,osrednji centralni vestibularni sindrom, disartrija in Parkinsonov sindrom.
English: Store in the original container.
Slovenian: Shranjujte v originalnem vsebniku.
English: Contents of the pack and other information What Lysodren contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Lysodren
English: Adverse reactions listed below are classified according to frequency and system organ class.
Slovenian: Spodaj našteti neželeni učinki zdravila so razvrščeni po organskem sistemu in pogostnosti.
English: Epigastric discomfort
Slovenian: Epigastrično nelagodje
English: Indeed, neurologic toxicity has been associated with levels above 20 mg/l and therefore this threshold should not be reached.
Slovenian: Pri koncentracijah nad 20 mg/l je dejansko prišlo do nevrološke toksičnosti, zato se tega praga ne sme preseči.
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.
Slovenian: V študiji z 8 bolniki s karcinomi nadledvične žleze, ki so bili zdravljeni z 2 do 3 g mitotana dnevno, so odkrili zelo dobro korelacijo med plazemskimi koncentracijami mitotana in skupnim odmerkom mitotana.
English: Lysodren with food and drink
Slovenian: Zdravilo Lysodren skupaj s hrano in pijačo:
English: This leaflet is available in all European languages on the EMA website.
Slovenian: To navodilo za uporabo je na voljo v vseh uradnih jezikih EU/EGP na spletni strani Evropske agencije za zdravila.
English: Mitotane plasma levels and the possible relationship with its efficacy were studied in the FIRM ACT trial, a randomized, prospective, controlled, open-label, multicenter, parallel-group study to compare the efficacy of etoposide, doxorubicin and cisplatin plus mitotane (EDP/M) to that of streptozotocin plus mitotane (Sz/M) as first-line treatment in 304 patients.
Slovenian: Ravni mitotana v plazmi in morebitno povezanost z njegovo učinkovitostjo so preučevali v preskušanju FIRM ACT - randomizirani, prospektivni, nadzorovani, odprti, multicentrični študiji z vzporednimi skupinami, v kateri so primerjali učinkovitost etopozida, doksorubicina ter cisplatina v kombinaciji z mitotanom (EDP/M) z učinkovitostjo kombinacije streptozotocina in mitotana (Sz/M)
English: A starting dose higher than 6 g/day is generally not recommended.
Slovenian: Na splošno ni priporočljivo uporabiti začetnih odmerkov, večjih od 6 g/dan.
English: One case of encephalopathy has been observed in a paediatric patient five months after initiation of the treatment; this case was considered to be related to an increased mitotane plasma level of 34.5 mg/l.
Slovenian: Pri enem pediatričnem bolniku so pet mesecev po začetku zdravljenja opazili primer encefalopatije, za katerega pa so menili, da ni povezan s povišano ravnijo mitotana v plazmi na 34,5 mg/l.
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.
Slovenian: V obeh študijah pa so opazili, da so se pri nekaterih bolnikih plazemske koncentracije mitotana še naprej povečevale ne glede na stalen ali zmanjšan dnevni odmerek mitotana.
English: If you are pregnant or planning to become pregnant, tell your doctor.
Slovenian: Zdravnika obvestite, če ste noseči ali če načrtujete nosečnost.
English: Due to the lipophilic nature of mitotane, it is likely to be excreted in breast milk.
Slovenian: Ker je mitotan lipofilne narave, je verjetno, da se izloča v materinem mleku.
English: White, biconvex, round, scored tablets.
Slovenian: Bele, bikonveksne, okrogle tablete z zarezami.
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).
Slovenian: Ker ni poznano, kateri izoencimi P450 so vpleteni, je potrebna pazljivost pri sočasnem predpisovanju zdravilnih učinkovin, ki se presnavljajo po tej poti, med drugim tudi antikonvulzivov, rifabutina, rifampicina, grizeofulvina in šentjanževke (Hypericum perforatum).
English: Available clinical information comes mainly from published data in patients with inoperable or metastatic adrenal carcinoma.
Slovenian: Klinični podatki, ki so na voljo, so zbrani predvsem iz objavljenih podatkov o bolnikih s kirurško neodstranljivimi ali metastatskimi karcinomi nadledvične žleze.
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).
Slovenian: Proteini, ki se vežejo na hormone: Pokazali so, da mitotan poveča plazemske koncentracije proteinov, ki se vežejo na hormone (npr. globulina, ki se veže na spolne hormone (SHBG) in globulina, ki se veže na kortikosteroide (CBG)).
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.
Slovenian: Poleg tega mitotan vzbudi stanje insuficience nadledvične žleze, zaradi česar izgine Cushingov sindrom pri bolnikih z izločujočim karcinomom nadledvične žleze, zaradi česar je potrebna nadomestna hormonska terapija.
English: - if you are allergic to mitotane or any of the other ingredients of this medicine (listed in section - if you are breast-feeding.
Slovenian: - če ste alergični na mitotan ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: Other medicines and Lysodren
Slovenian: Druga zdravila in zdravilo Lysodren
English: If you forget to take Lysodren
Slovenian: Če ste pozabili vzeti zdravilo Lysodren
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).
Slovenian: Ker mitotan zviša plazemske koncentracije beljakovin, ki se vežejo na stereoide, so za optimalno odmerjanje nadomestnih steroidov potrebna merjenja prostega kortizola in kortikotropina (ACTH) (glejte poglavje 4.8).
English: Caution and close monitoring of mitotane plasma levels are highly recommended when treating overweight patients.
Slovenian: Previdnost in pozorno spremljanje plazemskih koncentracij mitotana sta zelo priporočena pri zdravljenju bolnikov s prekomerno telesno maso.
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.
Slovenian: Plazemske koncentracije mitotana je treba izmeriti po vsakem prilagajanju odmerka in v pogostih intervalih (npr. vsaka dva tedna), dokler ni dosežen optimalni vzdrževalni odmerek.
English: Bottle of 100 tablets.
Slovenian: Plastenka s 100 tabletami.
English: Exogenous steroids should be administered in such circumstances, since the depressed adrenal gland may not immediately start to secrete steroids.
Slovenian: V teh primerih je potrebno dajati eksogene steroide, saj nadledvična žleza morda ne začne takoj izločati steroidov.
English: Therefore, monitoring of mitotane plasma levels (e.g. every two months) is also necessary after interruption of treatment, as prolonged release of mitotane can occur.
Slovenian: Zato je spremljanje plazemske koncentracije mitotana (npr. vsaka dva meseca) nujno tudi po prekinitvi zdravljenja, saj lahko pride do podaljšanega sproščanja mitotana.
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'
Slovenian: Študije presnove pri človeku so pokazale, da je poglavitni presnovek v obtoku 1,1-(o,p'-diklorodifenil) ocetna kislina (o,p'-DDA) z manjšimi količinami analoga mitotana 1,1-(o,p'-diklorodifenil)-2,2
English: Isolated cases of complicated cysts have been reported (adnexal torsion and haemorrhagic cyst rupture).
Slovenian: Poročali so o posameznih primerih zapletenih cist (torzija adneksov in razpok hemoragične ciste).
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.
Slovenian: Mitotan se po prekinitvi zdravljenja začne počasi sproščati iz maščobnih tkiv, kjer se nalaga, kar privede do terminalne razpolovne dobe 18 do 159 dni.
English: Mitotane plasma levels should therefore be monitored in order to adjust the Lysodren dose and to avoid reaching toxic levels.
Slovenian: Koncentracijo mitotana v plazmi je treba nadzorovati, da se prilagodi odmerek zdravila Lysodren in prepreči doseganje toksičnih koncentracij.
English: What you need to know before you take Lysodren Do not take Lysodren
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lysodren Ne jemljite zdravila Lysodren:
English: Substances metabolised through cytochrome P450: Mitotane has been shown to have an inductive effect on cytochrome P450 enzymes.
Slovenian: Snovi, ki se presnavljajo preko citokroma P450: Za mitotan je dokazano, da ima pospeševalni učinek na encime citokroma P450.
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).
Slovenian: Spironolakton: Mitotan se ne sme dajati sočasno s spironolaktonom, ker lahko ta zdravilna učinkovina ovira delovanje mitotana (glejte poglavje 4.3).
English: Oral use.
Slovenian: za peroralno uporabo.
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.
Slovenian: Pred začetkom zdravljenja: Pred začetkom zdravljenja z mitotanom je treba kirurško odstraniti velike metastatske mase, da se zmanjša tveganje za infarkt in krvavitve v tumorju zaradi hitrega citotoksičnega učinka mitotana.
English: Women of childbearing potential: Women of childbearing potential must use effective contraception during treatment with mitotane (see section 4.6).
Slovenian: Ženske v rodni dobi: Ženske v rodni dobi morajo v času zdravljenja z mitotanom uporabljati učinkovito kontracepcijsko metodo (glejte poglavje 4.6).
English: Concomitant use with spironolactone (see section 4.5)
Slovenian: Sočasna uporaba s spironolaktonom (glejte poglavje 4.5)
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.
Slovenian: Zdravljenje pri odraslih je treba začeti z odmerkom 2-3 g mitotana na dan in odmerek progresivno povečevati (npr. v dvotedenskih intervalih), dokler ravni mitotana v plazmi ne dosežejo območja terapevtskih koncentracij 14-20 mg/l.
English: Lysodren tablets are white, biconvex, round and scored.
Slovenian: Zdravilo Lysodren so bele, bikonveksne, okrogle tablete z zarezo.
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).
Slovenian: Snovi, ki se presnavljajo preko citokroma P450 in zlasti citokroma 3A4: Mitotan je pospeševalec jetrnih encimov in se mora uporabljati previdno v primerih sočasne uporabe zdravil, na katere vpliva jetrna presnova (glejte poglavje 4.5).
English: Medicinal products active on central nervous system: Mitotane can cause central nervous system undesirable effects at high concentrations (see section 4.8).
Slovenian: Zdravila, ki delujejo na osrednje živčevje: V visokih koncentracijah mitotan lahko povzroči neželene učinke v osrednjem živčnem sistemu (glejte poglavje 4.8).
English: SN: NN:
Slovenian: NN:
English: Data on a limited number of exposed pregnancies indicate abnormalities on the adrenals of the foetus after exposure to mitotane.
Slovenian: Podatki iz omejenega števila izpostavitev med nosečnostjo nakazujejo okvare nadledvične žleze pri plodu po izpostavljenosti mitotanu.
English: Each tablet contains 500 mg of mitotane.
Slovenian: Vsaka tableta vsebuje 500 mg mitotana.
English: Paediatric patients: In children and adolescents, neuro-psychological retardation can be observed during mitotane treatment.
Slovenian: Pediatrični bolniki: Pri otrocih in mladostnikih lahko v času zdravljenja z mitotanom opazimo nevropsihološko nazadovanje.
English: Available data suggest that mitotane modifies the peripheral metabolism of steroids and that it also directly suppresses the adrenal cortex.
Slovenian: Podatki, ki so na voljo, kažejo, da mitotan spremeni periferno presnovo steroidov, in da neposredno zavira delovanje skorje nadledvične žleze.
English: The threshold of 20 mg/l was reached for cumulative amounts of mitotane of approximately 500 g. In another study, 3 patients with adrenal carcinoma received Lysodren according to a precise protocol allowing fast introduction of a high dose if the product was well tolerated: 3 g (as 3 intakes) on day 1, 4.5 g on day 2, 6 g on day 3, 7.5 g on day 4 and 9 g on day 5.
Slovenian: 363 g) Pražna vrednost 20 mg/l je bila dosežena pri kumulativni količini mitotana približno 500 g. V drugi študiji so trije bolniki s karcinomom nadledvične žleze prejemali Lysodren po natančnem protokolu, ki je omogočal hitro vzpostavitev visokega odmerka (če so bolniki Lysodren dobro prenašali), in sicer: 3 g (v treh delih) prvi dan; 4,5 g drugi dan; 6 g tretji dan; 7,5 g četrti dan in 9 g peti dan. Odmerjanje Lysodrena se je nadaljevalo s prilagajanjem na pojavljanje neželenih učinkov in plazemske koncentracije mitotana.
English: - The other ingredients are maize starch, microcrystalline cellulose (E 460), macrogol 3350 and silica colloidal anhydrous.
Slovenian: - Pomožne snovi so koruzni škrob, mikrokristalna celuloza (E 460), makrogol 3350, brezvoden koloidni silicijev dioksid.
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.
Slovenian: Dajanja mitotana pri človeku spremeni presnovo kortizola izven nadledvične žleze, kar zmanjša merljive koncentracije 17-hidroksi kortikosteroidov, čeprav ostanejo koncentracije kortikosteroidov v plazmi nespremenjene.
English: Nervous system undesirable effects appear reversible after cessation of mitotane treatment and decrease in plasma levels (see section 4.4).
Slovenian: Izgleda, da so neželeni učinki na živčevje reverzibilni po prekinitvi zdravljenja z mitotanom in po znižanju plazemskih koncentracij (glejte poglavje 4.4).
English: Your doctor should do blood tests to check your liver function before and during treatment with Lysodren, and as clinically indicated.
Slovenian: Vaš zdravnik mora narediti krvne teste za preverjanje delovanja jeter pred in med zdravljenjem z zdravilom Lysodren ter kot je klinično indicirano; - če imate hude težave z ledvicami;
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).
Slovenian: Za doseganje želenih terapevtskih ravni v območju 14-20 mg/l in izogibanje specifičnim neželenim reakcijam je morda potrebno prilagajanje odmerka (glejte poglavje 4.2).
English: Mitotane overdose may lead to central nervous system impairment especially if mitotane plasma levels are above 20 mg/l.
Slovenian: Preveliko odmerjanje mitotana lahko povzroči motnje delovanja osrednjega živčnega sistema, še posebej če so plazemske koncentracije mitotana večje od 20 mg/l.
English: However, dichlorodiphenyltrichlorethane (DDT) and other polychlorinated biphenyl analogues are known to have deleterious effects on fertility, pregnancy and development, and mitotane could be expected to share these properties.
Slovenian: Vendar so diklorodifeniltrikloretan (DDT) in drugi analogi polikloriranih difenilov znani po škodljivih učinkih na plodnost, nosečnost in telesni razvoj.
English: Premenopausal women: Ovarian macrocysts have been observed with higher incidence in this population.
Slovenian: Ženske pred menopavzo: v tej populaciji so opazili večjo pojavnost makrocist na jajčnikih.
English: Women of childbearing potential must use an effective contraception during treatment and after discontinuation of treatment as long as mitotane plasma levels are detectable.
Slovenian: Ženske v rodni dobi morajo v času zdravljenja in po prekinitvi zdravljenja, dokler so koncentracije mitotana v plazmi zaznavne, uporabljati učinkovito kontracepcijsko metodo.
English: Treatment can be resumed when mitotane plasma levels will be ranged between 14 - 20 mg/l.
Slovenian: Zdravljenje se lahko nadaljuje, ko je plazemska koncentracija mitotana med 14 in 20 mg/l.
English: Warfarin and coumarin-like anticoagulants: When administering mitotane to patients on coumarinlike anticoagulants, patients should be closely monitored for a change in anticoagulant dose requirements (see section 4.5).
Slovenian: Varfarin in kumarinu podobna antikoagulacijska zdravila: Kadar se mitotan daje bolnikom, ki uporabljajo kumarinu podobne antikoagulante, je treba bolnike skrbno spremljati zaradi morebitne spremembe odmerka antikoagulacijskega zdravila (glejte poglavje 4.5).
English: Therefore, the plasma concentrations of the substances metabolised via cytochrome 3A4 may be modified.
Slovenian: Zato se lahko spremenijo plazemske koncentracije snovi, ki se presnavljajo prek citokroma 3A4.