FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall summary of the scientific evaluation by the CHMP Based on the review of all available data, the consultations with the Healthcare Professionals Organisations (HCPOs) and Scientific Advisory Group (SAG) Psychiatry, the CHMP recommended the following revisions to harmonise the product information for Haldol oral and injectable formulations.
Slovenian: Na podlagi pregleda vseh razpoložljivih podatkov ter posvetovanja z organizacijami zdravstvenih delavcev in znanstveno svetovalno skupino za psihiatrijo je odbor CHMP predlagal naslednje popravke za uskladitev informacij o zdravilu Haldol v formulacijah za peroralno uporabo in injiciranje.
English: As CYP3A4 and, to a lesser extent, CYP2D6 are involved in the metabolism of haloperidol, the potential increase in haloperidol plasma concentrations when a CYP3A4 and/or CYP2D6 inhibitor is coadministered may range between 20 to 40%, although in some cases, increases of up to 100% have been reported, and has been added in section 4.5 Interaction with other medicinal products and other forms of interaction.
Slovenian: Ker CYP3A4 in v manjši meri tudi CYP2D6 sodelujeta pri presnovi haloperidola, je morebitno povečanje koncentracije haloperidola v plazmi ob sočasni uporabi zaviralca CYP3A4 in/ali CYP2D6 v razponu od 20 do 40 %, čeprav so v nekaterih primerih ugotovili povečanje do 100 %.
English: • The Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Slovenian: • odbor CHMP je pregledal vse podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom.
English: Minor changes were included in the remaining sections of the SmPC.
Slovenian: V preostale dele povzetka glavnih značilnosti zdravila so bile vključene manjše spremembe.
English: Grounds for the CHMP opinion Whereas
Slovenian: Podlaga za mnenje odbora CHMP Ob upoštevanju naslednjega:
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Slovenian: Spremembe povzetka glavnih značilnosti zdravila, ki so pomembne za uporabnika, so bile prenesene tudi v navodilo za uporabo in potrjene s strani odbora CHMP.
English: It is a potent central dopamine type 2 receptor antagonist, and at recommended dosages, has no antihistaminergic or anticholinergic activity and minimal alpha 1 adrenergic activity.
Slovenian: V priporočenih odmerkih nima antihistaminergičnega ali antiholinergičnega delovanja in ima minimalno adrenergično delovanje alfa 1.
English: - Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer's dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others.
Slovenian: - zdravljenje perzistentne agresivnosti in psihotičnih simptomov pri bolnikih z zmerno do hudo Alzheimerjevo demenco in vaskularno demenco, če nefarmakološko zdravljenje ni uspelo ali obstaja tveganje poškodovanja sebe ali drugih;
English: Furthermore, observational studies have consistently reported an increased mortality in elderly haloperidol users - the highest mortality risk with haloperidol was in the first 30 days and persists for at least 6 months.
Slovenian: Največje tveganje umrljivosti zaradi haloperidola je bilo v prvih 30 dneh in je trajalo najmanj 6 mesecev.
English: - Symptoms of persistent aggression in children with autism or pervasive developmental disorders
Slovenian: - simptomi perzistentne agresivnosti pri otrocih z avtizmom in prodornimi motnjami v razvoju.
English: - Tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed.
Slovenian: - motnje tikov, vključno s Tourettovim sindromom, pri otrocih in mladostnikih, starih od 10 do 17 let, s hudo okvaro po neuspešnih izobraževalnih, psiholoških in drugih farmakoloških zdravljenjih.
English: - Treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.
Slovenian: - zdravljenje motnje tikov, vključno s Tourettovim sindromom, pri bolnikih s hudo okvaro po neuspešnih izobraževalnih, psiholoških in drugih farmakoloških zdravljenjih;
English: - Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated.
Slovenian: - perzistentne, hude agresije pri otrocih in mladostnikih, starih od 6 do 17 let, z avtizmom ali prodorno razvojno motnjo, če druge oblike zdravljenja niso bile uspešne ali pa jih bolnik ne prenaša;
English: Angioedema was added to section 4.8 Undesirable effects and additional information on the site of action of injectable haloperidol in the treatment and prophylaxis of nausea and vomiting has been included in section 5.1 Pharmacodynamic properties.
Slovenian: V poglavje 4.8 Neželeni učinki je bil dodan angioedem, v poglavje 5.1 Farmakodinamične lastnosti pa dodatne informacije o mestu delovanja haloperidola za injiciranje za zdravljenje in preprečevanje siljenja na bruhanje in bruhanja.
English: - Schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated.
Slovenian: - shizofrenije pri mladostnikih, starih od 13 do 17 let, če druga farmakološka zdravljenja niso bila uspešna ali pa jih bolnik ne prenaša;
English: A SAG and HCPOs consultations were carried out during this procedure at the request of the CHMP.
Slovenian: Na zahtevo odbora CHMP so bila v tem postopku opravljena posvetovanja z znanstveno svetovalno skupino in organizacijami zdravstvenih delavcev.
English: - Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder.
Slovenian: - zdravljenje akutne psihomotorične agitacije, povezane s psihotično motnjo ali z maničnimi epizodami bipolarne motnje I;
English: - Treatment of moderate to severe manic episodes associated with bipolar I disorder.
Slovenian: - zdravljenje zmernih do hudih maničnih epizod, povezanih z bipolarno motnjo I;
English: - Single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated.
Slovenian: - posamezna ali kombinirana profilaksa pri bolnikih z zmernim do visokim tveganjem za pooperativno siljenje na bruhanje in bruhanje, če so druga zdravila neučinkovita ali jih bolnik ne prenaša;
English: - Treatment of schizophrenia in paediatric population
Slovenian: - zdravljenje shizofrenije pri otrocih;
English: - Combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not tolerated.
Slovenian: - kombinirano zdravljenje pooperativnega siljenja na bruhanje in bruhanja, če so druga zdravila neučinkovita ali jih bolnik ne prenaša.
English: - Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate.
Slovenian: - zdravljenje blage do zmerne horee pri Huntingtonovi bolezni, če druga zdravila niso učinkovita, jih bolnik ne prenaša ali peroralno zdravljenje ni primerno;
English: For the injectable formulations: - Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate.
Slovenian: - hitro obvladanje akutne psihomotorične agitacije, povezane s psihotično motnjo ali z maničnimi epizodami bipolarne motnje I, če peroralno zdravljenje ni primerno;
English: - Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated.
Slovenian: - zdravljenje blage do zmerne horee pri Huntingtonovi bolezni, če druga zdravila niso učinkovita ali jih bolnik ne prenaša.
English: Pharmaceutical Form Route of Administration Packaging
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: Page 1/1
Slovenian: Številka EU
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Slovenian: Izmišljeno ime
English: These improvements were not statistically significant.
Slovenian: Omenjeno izboljšanje ni bilo statistično značilno.
English: Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/09/2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 08.09.2015
English: About 4% of an oral dose is excreted unchanged in urine.
Slovenian: 4 % peroralnega odmerka se izloča nespremenjenega z urinom.
English: If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
Slovenian: Če se to zgodi vam, bodite previdni pri vožnji ali upravljanju strojev v času, ko bi lahko prihajalo do nenadnih sprememb jakosti svetlobe, zlasti ko vozite ponoči.
English: Children Ivabradine Anpharm is not intended for use in children and adolescents younger than 18 years.
Slovenian: Ivabradine Anpharm ni namenjen za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment.
Slovenian: Vsi fosfeni so ponehali med zdravljenjem ali po njem, in sicer večina med zdravljenjem (77,5 %).
English: (see section 5.1)
Slovenian: (glejte poglavje 5.1).
English: In this way Ivabradine Anpharm helps to control and reduce the number of angina attacks.
Slovenian: Na ta način Ivabradine Anpharm pripomore k nadzoru in zmanjševanju anginoznih napadov.
English: If you forget to take a dose of Ivabradine Anpharm, take the next dose at the usual time.
Slovenian: Če ste pozabili vzeti odmerek zdravila Ivabradine Anpharm, vzemite naslednji odmerek ob običajnem času.
English: The long-term effects of ivabradine on growth, puberty and general development as well as the longterm efficacy of therapy with ivabradine in childhood to reduce cardiovascular morbidity and mortality have not been studied.
Slovenian: Dolgoročni učinki ivabradina na rast, puberteto in splošen razvoj, kakor tudi dolgoročna učinkovitost terapije z ivabradinom za zmanjševanje srčno-žilne umrljivosti in umrljivosti v otroški dobi niso bili preučevani.
English: If you think that the effect of Ivabradine Anpharm is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Ivabradine Anpharm premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in all subsets of the paediatric population for the treatment of angina pectoris.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z ivabradinom za vse podskupine pediatrične populacije za zdravljenje angine pektoris.
English: 74 received ivabradine (ratio 2:1).
Slovenian: 74 bolnikov je prejemalo ivabradin (razmerje 2:1).
English: It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers.
Slovenian: Uporablja se pri odraslih bolnikih, ki ne prenašajo ali ne morejo jemati zdravil za srce, imenovanih antagonisti receptorjev beta.
English: The most common adverse reactions with this medicine are dose dependent and related to its mode of action:
Slovenian: Najpogostejši neželeni učinki tega zdravila so odvisni od odmerka ter so povezani z njegovim mehanizmom delovanja: Zelo pogosti:
English: The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Slovenian: Možen nastanek tovrstnih pojavov svetlikanja morate upoštevati pri vožnji ali upravljanju s stroji v pogojih, kjer se lahko nenadno spreminja jakost svetlobe, zlasti med vožnjo ponoči.
English: If you are pregnant and have taken Ivabradine Anpharm, talk to your doctor.
Slovenian: Če ste noseči in ste jemali zdravilo Ivabradine Anpharm, se posvetujte z zdravnikom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ivabradine in children aged 0 to less than 6 months for the treatment of chronic heart failure.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z ivabradinom za otroke od 0 do manj kot 6 mesecev starosti za zdravljenje kroničnega srčnega popuščanja.
English: The results on the primary endpoint are mainly driven by the heart failure endpoints, hospitalisation for worsening heart failure (absolute risk reduced by 4.7 %) and deaths from heart failure (absolute risk reduced by 1.1 %).
Slovenian: Rezultat končnega izida je izmerjen predvsem na podlagi izidov srčnega popuščanja, hospitalizacij zaradi poslabšanj srčnega popuščanja (absolutno zmanjšanje tveganja za 4,7 %) in umrljivosti zaradi srčnega popuščanja (absolutno zmanjšanje tveganja za 1,1 %).
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Anpharm.
Slovenian: Koledar, ki je natisnjen na pretisnem omotu s tabletami, vam pomaga, da si zapomnite, kdaj ste nazadnje vzeli tableto zdravila Ivabradine Anpharm.
English: Ivabradine is contraindicated in patients with severe hypotension (blood pressure < 90/50 mmHg) (see section 4.3).
Slovenian: Ivabradin je kontraindiciran pri bolnikih s hudo hipotenzijo (krvnim tlakom < 90/50 mm Hg) (glejte poglavje 4.3).
English: Ivabradine Anpharm may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Slovenian: Ivabradine Anpharm lahko povzroča začasne vidne pojave svetlikanja (prehodno povečanje svetlosti v vidnem polju, glejte “Možni neželeni učinki”).
English: Excipient with known effect: 61.215 mg lactose monohydrate
Slovenian: Pomožna snov z znanim učinkom: 61,215 mg laktoze monohidrata.
English: Patients received standard care including beta-blockers (89 %), ACE inhibitors and/or angiotensin II antagonists (91 %), diuretics (83 %), and anti-aldosterone agents (60 %).
Slovenian: Bolniki so prejemali standardno zdravljenje, ki je vključevalo antagoniste adrenergičnih receptorjev beta (89 %), zaviralce ACE in/ali antagoniste angiotenzina II (91 %), diuretike (83 %) in antagoniste aldosterona (60 %).
English: AV 2nd degree block, AV 3rd degree block
Slovenian: AV blok 2. stopnje, AV blok 3. stopnje sindrom bolnega sinusnega vozla
English: Efficacy was confirmed with 7.5 mg twice daily.
Slovenian: Učinkovitost so potrdili z odmerkom 7,5 mg dvakrat na dan.
English: The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
Slovenian: Poglavitni aktivni presnovek je N-demetilirani derivat (S 18982) z izpostavljenostjo, ki znaša približno 40 % tiste pri matični učinkovini.
English: Ivabradine Anpharm mainly works by reducing the heart rate by a few beats per minute.
Slovenian: Ivabradine Anpharm deluje predvsem tako, da znižuje srčno frekvenco za nekaj utripov na minuto.
English: In this study, ivabradine was administered as oral liquid formulation or tablet twice daily.
Slovenian: V tej študiji so ivabradin dajali v obliki peroralne tekočine oz. tablet dvakrat na dan.
English: - Chronic heart failure in adult patients whose heart rate is over or equal to 75 beats per minute.
Slovenian: - odraslih bolnikov s kroničnim srčnim popuščanjem in srčnim utripom višjim ali enakim 75 utripom na minuto.
English: Annopol 6B - 03-236 Warszawa, Poland Laboratorios Servier, S.L, Avda.
Slovenian: Annopol 6B - 03-236 Varszawa, Poljska Laboratorios Servier, S.L, Avda.
English: Ivabradine Anpharm should be taken during meals.
Slovenian: Zdravilo Ivabradine Anpharm morate jemati med obrokom.
English: Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo.
Slovenian: Ivabradin je S-enantiomer in ni dokazov za njegovo biološko konverzijo in vivo.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine Anpharm.
Slovenian: Če karkoli od naštetega velja za vas, se takoj pogovorite z zdravnikom pred jemanjem zdravila Ivabradine Anpharm ali med njim.
English: - Paediatric population: The pharmacokinetic profile of ivabradine in paediatric chronic heart failure patients aged 6 months to less than 18 years is similar to the pharmacokinetics described in adults when a titration scheme based on age and weight is applied.
Slovenian: - Pediatrična populacija: farmakokinetični profil ivabradina pri pediatričnih bolnikih s kroničnim srčnim popuščanjem, starih od 6 mesecev do manj kot 18 let, je podoben farmakokinetičnim lastnostim, ki so opisane pri odraslih bolnikih, ko se uporablja shema titriranja, ki temelji na starosti in telesni masi bolnika.
English: Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour monitoring should be considered when determining resting heart rate before initiation of ivabradine treatment and in patients on treatment with ivabradine when titration is considered.
Slovenian: Glede na to, da lahko srčna frekvenca precej niha, morate razmisliti o zaporednem merjenju srčne frekvence, EKG in 24-urnem ambulantnem spremljanju, ko določate srčno frekvenco v mirovanju pred uvedbo zdravljenja z ivabradinom ter pri bolnikih, ki jemljejo ivabradin in pri katerih menite, da je potrebno titrirati odmerek.
English: The safety and efficacy of ivabradine for the treatment of chronic heart failure in children aged below 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost ivabradina pri zdravljenju kroničnega srčnega popuščanja pri otrocih, mlajših od 18 let, nista bili dokazani.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people rare: may affect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 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 največ 1 od 10 bolnikov občasni: pojavijo se lahko pri največ 1 od 100 bolnikov redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
English: In the SIGNIFY study atrial fibrillation was observed in 5.3% of patients taking ivabradine compared to 3.8% in the placebo group.
Slovenian: V študiji SIGNIFY so opažali atrijsko fibrilacijo pri 5,3 % bolnikov, ki so jemali ivabradin, v primerjavi s 3,8 % bolnikov, ki so prejemali placebo.
English: Heart failure must be stable before considering ivabradine treatment.
Slovenian: Srčno popuščanje naj bo stabilno, preden se odločite za zdravljenje z ivabradinom.
English: Irregular rapid contraction of the heart, abnormal perception of heartbeat, uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).
Slovenian: Neredne, hitre kontrakcije srčne mišice, nenormalno zaznavanje srčnega utripa, nenadzorovan krvni tlak, glavobol, omotica in zamegljen vid (nejasen vid).
English: - Renal impairment: the impact of renal impairment (creatinine clearance from 15 to 60 ml/min) on ivabradine pharmacokinetic is minimal, in relation with the low contribution of renal clearance (about 20 %) to total elimination for both ivabradine and its main metabolite S 18982 (see section
Slovenian: - Ledvična okvara: učinek ledvične okvare (očistek kreatinina od 15 do 60 ml/min) na farmakokinetiko ivabradina je minimalen, kar je povezano z majhnim prispevkom ledvičnega očistka (približno 20 %) k skupnemu izločanju tako ivabradina kot njegovega poglavitnega presnovka S 18982 (glejte poglavje 4.2).
English: The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation.
Slovenian: Učinki v srcu so specifični za sinusni vozel, brez delovanja na čase intraatrijskega, atrioventrikularnega ali intraventrikularnega prevajanja, ali na kontraktilnost miokarda ali repolarizacijo prekatov.
English: The safety profile, over one year, was similar to the one described in adult CHF patients.
Slovenian: Po enem letu je bil varnostni profil v skladu s tistim pri odraslih bolnikih s kroničnim srčnim popuščanjem.
English: In addition there was no clinically significant effect of ivabradine on the pharmacokinetics of simvastatin, amlodipine, lacidipine, on the pharmacokinetics and pharmacodynamics of digoxin, warfarin and on the pharmacodynamics of aspirin.
Slovenian: Poleg tega ivabradin ni imel klinično signifikantnega učinka na farmakokinetiko simvastatina, amlodipina in lacidipina, na farmakokinetiko ter farmakodinamiko digoksina in varfarina ter na farmakodinamiko aspirina.
English: Ivabradine is contraindicated for use in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated (see sections 4.3 and 5.2).
Slovenian: Pri bolnikih s hudo jetrno okvaro je ivabradin kontraindiciran, saj ga pri njih niso proučevali in bi lahko pričakovali veliko povečanje sistemske izpostavljenosti (glejte poglavji 4.3 in 5.2).
English: The PK/PD relationship of ivabradine in paediatric chronic heart failure patients aged 6 months to less than 18 years is similar to the PK/PD relationship described in adults.
Slovenian: razmerje ivabradina pri pediatričnih bolnikih s kroničnim srčnim popuščanjem, starih od 6 mesecev do manj kot 18 let, je podobno PK/PD razmerju, ki so ga opisali pri odraslih.
English: What Ivabradine Anpharm is and what it is used for What you need to know before you take Ivabradine Anpharm How to take Ivabradine Anpharm Possible side effects
Slovenian: Kaj je zdravilo Ivabradine Anpharm in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ivabradine Anpharm Kako jemati zdravilo Ivabradine Anpharm
English: In the SHIFT trial more patients experienced episodes of increased blood pressure while treated with ivabradine (7.1%) compared to patients treated with placebo (6.1%).
Slovenian: V študiji SHIFT je imelo več bolnikov med zdravljenjem z ivabradinom obdobja zvišanega krvnega tlaka (7,1 %) v primerjavi z bolniki, ki so prejemali placebo (6,1 %).
English: What Ivabradine Anpharm contains - The active substance is ivabradine (as hydrochloride).
Slovenian: Kaj vsebuje zdravilo Ivabradine Anpharm - Učinkovina je ivabradin (v obliki klorida).
English: There is no evidence of a toxic effect of long-term ivabradine treatment on the retina (see section 5.1).
Slovenian: Ni dokazov, da bi imelo dolgotrajno zdravljenje z ivabradinom toksičen učinek na mrežnico (glejte poglavje 5.1).
English: Symptomatic treatment of chronic stable angina pectoris
Slovenian: 4.1 Terapevtske indikacije Simptomatsko zdravljenje kronične stabilne angine pektoris
English: - Hepatic impairment: in patients with mild hepatic impairment (Child Pugh score up to 7) unbound AUC of ivabradine and the main active metabolite were about 20% higher than in subjects with normal hepatic function.
Slovenian: - Jetrno popuščanje: pri bolnikih z blagim jetrnim popuščanjem (Child-Pughov seštevek do 7) je nevezana površina pod krivuljo (AUC) ivabradina in poglavitnega aktivnega presnovka za približno 20 % večja, kot pri preiskovancih z normalnim delovanjem jeter.