natgillin/translations-raw huggingface dataset:
Up to now there are no indications for harmfulness in animal tests, possible effects on the foetal eye have not been examined, though.
Testi na živalih doslej niso odkrili škodljivih učinkov, niso pa bili raziskani možni učinki na oko ploda.
Suicide/suicidal thoughts or clinical worsening:
Samomor/samomorilne misli ali klinično poslabšanje:
Your doctor may continue to prescribe Seroquel XR even when you are feeling better.
Zdravnik vam lahko še naprej predpiše Seroquel SR, tudi če se počutite bolje.
Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.
Formalnih študij medsebojnega delovanja s pogosto uporabljanimi srčno-žilnimi zdravili ni bilo.
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Taking these findings into consideration, the benefits of the treatment with quetiapine need to be balanced against the safety risks for the patient.
Upoštevaje te izsledke je treba koristi zdravljenja s kvetiapinom pretehtati v primerjavi z varnostnimi tveganji za bolnika.
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The degree to which quetiapine is excreted into human milk is unknown.
Ni znano, v kolikšni meri se kvetiapin izloča v materino mleko pri človeku.
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The reduction in total and free T4 was maximal within the first two to four weeks of Seroquel treatment, with no further reduction during long-term treatment.
Znižanje celotnega in prostega T4 je bilo največje v prvih dveh do štirih tednih zdravljenja z zdravilom Seroquel; med dolgotrajnim zdravljenjem ni prišlo do dodatnega znižanja.
The need to increase the dose from 150 to 300 mg/day should be based on individual patient evaluation.
Potreba po povečanju odmerka s 150 na 300 mg/dan mora temeljiti na oceni posameznega bolnika.
(19) Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase.
(19) Pojav bolnikov, ki imajo spremembo QT iz < 450 msek na ≥ 450 msek z ≥30 msek povečanjem.
¾Swedish Record Linkage Study (SE-RLS) in accordance with an agreed protocol.
¾ švedsko študijo povezovanja kartotek (SE-RLS) v skladu z dogovorjenim protokolom.
• Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed
• shizofrenije: ko lahko slišite ali zaznavate stvari, ki jih ni, verjamete v stvari, ki niso resnične ali se počutite nenavadno sumničave, zaskrbljene, zmedene, krive, napete ali depresivne.
The available evidence from placebo-controlled clinical trials with Seroquel is presented in sections 4.4, 4.8, 5.1 and 5.2..
Ugotovitve s placebom kontroliranih kliničnih preskušanj zdravila Seroquel so predstavljene v poglavjih 4.4, 4.8, 5.1 in 5.2.
The administration of activated charcoal should be considered.
Lahko razmislimo o uporabi aktivnega oglja.
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Mean change among patients who had this increase was 41.7 mg/dL ( 1.07 mmol/L).
Povprečna sprememba pri bolnikih, ki imajo to povečanje je bila 41,7 mg/dl (≥ 1,07 mmol/l).
The target population have not been studied in the placebo controlled monotherapy studies and the potential better safety profile of alternative antidepressants precluded a positive balance between efficacy and safety in the claimed indication.
Ciljne populacije se ni proučilo v študijah monoterapije, nadzorovanih s placebom, potencialno boljši varnostni profil alternativnih antidepresivov pa je preprečil pozitivno ravnotežje med učinkovitostjo in varnostjo v navedeni indikaciji.
Venous Thromboembolism (VTE):
Venska tromboembolija (VTE):
Thus the potential benefit as add-on treatment was considered.
Zato je bila proučena morebitna korist zdravila, namenjenega dodatnemu zdravljenju.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE, IMETNIKOV DOVOLJENJ ZA PROMET V DRŽAVAH ČLANICAH
Less than 1% of patients had an increase to a prolactin level >100 ug/L.
Manj kot 1 % bolnikov se je koncentracija prolaktina zvišala na > 100 ug/l.
• Seroquel XR can be affected by food and you should therefore take your tablets at least one hour before a meal or prior to bedtime.
• Hrana lahko vpliva na zdravilo Seroquel SR, zato morate vzeti tableto vsaj eno uro pred obrokom ali pred spanjem.
The amended protocols should be submitted to the Reference Member State within two months of the CHMP Opinion on this referral procedure.
Spremenjene protokole je treba predložiti referenčni državi članici v roku dveh mesecev od datuma mnenja CHMP o tem postopku napotitve;
The average molar dose fraction of free quetiapine and the active human plasma metabolite norquetiapine is <5% excreted in the urine.
Povprečni delež molarnega odmerka prostega kvetiapina in aktivnega humanega plazemskega presnovka norkvetiapina, ki se izloči v urinu, je < 5 %.
However, the committee agreed that long-term safety on add-on treatment is needed when considering the potentially large number of possible combinations and the potential long-term safety concerns identified (i.e. metabolic changes and EPS related events).
Vendar se je odbor strinjal, da je potrebna dolgoročna varnost dodatnega zdravljenja, če se proučuje potencialno veliko število možnih kombinacij, poleg tega pa je treba opredeliti morebitne dolgoročne varnostne pomisleke (tj. metabolne spremembe in neželene učinke, povezane z EPS).
• Abnormal muscle movements.
• Nenormalne gibe mišic.
Mild asthenia, peripheral oedema, irritability
blaga astenija, periferni edemi, razdražljivost
Other psychiatric conditions for which Seroquel XR is prescribed can also be associated with an increased risk of suicide related events.
Druga psihiatrična stanja za katere se predpisuje zdravilo Seroquel SR so lahko tudi povezana s povečanjem tveganja za dogodke, povezane s samomorom.
• Feeling more hungryIncreased appetite
• Občutek večje lakote
Elderly patients with dementia-related psychosis: Seroquel XR is not approved for the treatment of dementia-related psychosis.
Starejši bolniki s psihozo, povezano z demenco: Zdravilo Seroquel SR ni odobreno za zdravljenje psihoze, povezane z demenco.
Caution should be exercised when quetiapine is used concomitantly with medicinal products known to cause electrolyte imbalance or to increase QT interval.
Potrebna je previdnost, če se kvetiapin uporablja sočasno z zdravili, za katere je znano, da povzročijo elektrolitsko neravnovesje ali podaljšajo QTc interval.
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Whilst the prevention of absorption in overdose has not been investigated, gastric lavage can be indicated in severe poisonings and if possible to perform within one hour of ingestion.
Čeprav preprečevanje absorpcije pri prevelikem odmerjanju ni raziskano, lahko uporabimo izpiranje želodca pri hudi zastrupitvi in, če je mogoče ne kasneje od ene ure po zaužitju.
Nonetheless, the CHMP noted that the pattern of adverse events in the randomised phase of this stidy was similar to that seen in the short-term studies.
Kljub temu je CHMP ugotovil, da je vzorec neželenih učinkov v naključni fazi te študije podoben vzorcu v kratkoročnih študijah.
• Bipolar depression and major depressive episodes in major depressive disorder: where you may feel sad or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can't sleep.
• bipolarne depresije in velike depresivne epizode pri veliki depresivni motnji: ko se lahko počutite žalostne ali depresivne, krive, brez energije, izgubite apetit ali ne morete spati.
An increase in LDL cholesterol of ≥30 mg/dL ( 0.769 mmol/L) has been very commonly observed.
Povečanje LDL holesterola ≥ 30 mg/dl (≥ 0,769 mmol/l) je bilo opisano v zelo pogostih primerih.
Increased appetite
večji apetit
The incidences of ADRs associated with quetiapine therapy, are tabulated below according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group 1995).
Pogostnost pojavljanja neželenih učinkov, povezanih z uporabo kvetiapina, je navedena v spodnji tabeli v skladu z obliko, ki jo priporoča Council for International Organizations of Medical Sciences (Delovna skupina CIOMS III 1995).
This may make you feel dizzy or faint (may lead to falls).
Posledica sta lahko omotica ali omedlevica (lahko povzroči padce).
Priapism, Galactorrhoea
priapizem, galaktoreja
The protocol should be submitted to the Reference Member State within two months of the CHMP Opinion on this referral procedure.
Slednjega je treba predložiti referenčni državi članici v roku dveh mesecev od datuma mnenja CHMP o tem postopku napotitve;
This increase in clearance reduced systemic quetiapine exposure (as measured by AUC) to an average of 13% of the exposure during administration of quetiapine alone; although a greater effect was seen in some patients.
To povečanje očistka je zmanjšalo sistemsko izpostavljenost kvetiapinu (merjeno z AUC) na povprečno 13 % izpostavljenosti med uporabo samega kvetiapina, pri nekaterih bolnikih pa je bil zabeležen večji učinek.
The incidence of these reactions had decreased significantly after 1 week postdiscontinuation.
Incidenca simptomov se je sigifikantno zmanjšala po enem tednu po odtegnitvi.
The overall safety profile in the elderly patients was similar to that in younger adult patients; however a higher frequency of somnolence, dizziness and extrapyramidal symptoms (EPS) was observed.
Splošni varnostni profil pri starejših bolnikih je bil podoben varnostnemu profilu pri mlajših odraslih bolnikih; vendar so bili pogosteje opaženi zaspanost, vrtoglavica in ekstrapiramidni simptomi (EPS).
The CHMP re-evaluated the data submitted by the MAH in the Mutual Recognition type II variation, additional information submitted by the MAH in written and by oral explanations during this referral procedure.
CHMP je ponovno proučil podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom v spremembi tipa II po postopku z medsebojnim priznavanjem, in dodatne informacije, ki jih je imetnik dovoljenja za promet z zdravilom predložil v pisnih ali ustnih obrazložitvah med tem postopkom napotitve.
In the 6-week active-controlled switching study the primary outcome variable was the proportion of patients who showed lack of efficacy, ie, who discontinued study treatment due to lack of efficacy or whose PANSS total score increased 20% or more from randomization to any visit.
V 6-tedenski študiji prehoda z aktivno kontrolo je bila primarna spremenljivka izida delež bolnikov, pri katerih učinkovitost ni bila zadostna, tj. bolnikov, ki so študijo zaradi nezadostne učinkovitosti prekinili ali pri katerih se je celotni seštevek po PANSS v primerjavi z randomizacijo na kateremkoli pregledu povečal za 20 % ali več.
Important information about some of the ingredients of Seroquel XR Seroquel XR contains lactose which is a type of sugar.
Pomembne informacije o nekaterih sestavinah zdravila Seroquel SR Zdravilo Seroquel SR vsebuje laktozo, ki je vrsta sladkorja.
Dysphagia8
disfagija8
Although long-term efficacy data are lacking the committee concluded to be acceptable to extrapolate maintenance data from the monotherapy studies.
Čeprav manjkajo podatki o dolgoročni učinkovitosti, je odbor zaključil, da je sprejemljivo pridobiti vzdrževalne podatke iz študij monoterapije;
The CHMP concluded that the safety profile for add-on treatment in short-term studies was similar to the safety demonstrated for mono-therapy.
CHMP je zaključil, da je bil varnostni profil dodatnega zdravljenja v kratkoročnih študijah podoben varnosti, izkazani pri monoterapiji.
Perform the following new PASS studies in MDD patients to further characterise the long-term safety and use of quetiapine XR, including the specialist care setting:
izvesti naslednje nove študije o varnosti po odobritvi pri bolnikih z MDD, da bi nadalje opredelili dolgoročno varnost in uporabo kvetiapina XR, vključno z opredelitvijo specialistične oskrbe:
Leucopenia 1
levkopenija1
Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatinine phosphokinase.
Med kliničnimi znaki so hipertermija, spremenjeno duševno stanje, mišična rigidnost, avtonomna nestabilnost in zvišanje kreatin-fosfokinaze.
If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Seroquel XR should be considered.
Če se pojavijo znaki in simptomi zapoznele diskinezije, je potrebno premisliti o zmanjšanju odmerka ali prekinitvi uporabe zdravila Seroquel SR.
(5) Exacerbation of pre-existing diabetes has been reported in very rare cases.
(5) V zelo redkih primerih je bilo opisano poslabšanje obstoječe sladkorne bolezni.
The mean clearance of quetiapine in the elderly is approximately 30 to 50% lower than that seen in adults aged 18 to 65 years.
Povprečni očistek kvetiapina pri starejših je za približno 30 do 50 % manjši kot pri odraslih v starosti od 18 do 65 let.
Metabolic Risk
Metabolično tveganje:
The pharmacokinetics of quetiapine does not differ between men and women.
Spol: Kinetika kvetiapina se med moškimi in ženskami ne razlikuje.
In post marketing experience, there have been very rare reports of overdose of quetiapine alone resulting in death or coma or QT-prolongation.
V obdobju po trženju zdravila so opisani zelo redki primeri prevelikega odmerjanja samega kvetiapina, ki so povzročili smrt ali komo ali podaljšanje intervala QT.
On the basis of this, concomitant use of quetiapine with CYP3A4 inhibitors is contraindicated.
Glede na to je sočasna uporaba kvetiapina z zaviralci CYP3A4 kontraindicirana.
Taking Seroquel XR with food and drink
Jemanje zdravila Seroquel SR skupaj s hrano in pijačo
This is most likely to occur within the first few weeks of treatment.
Pojavi se pretežno v prvih tednih zdravljenja.
In addition, a 6-week placebo controlled study for the treatment of schizophrenia (n = 222 patients, aged 13-17) was performed.
Poleg tega je bila opravljena 6-tedenska, s placebom kontrolirana študija za zdravljenje shizofrenije (n = 222 bolnikov, starih od 13 do 17 let).
Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period and therefore dose reduction or more gradual titration should be considered if this occurs.
Kvetiapin lahko povzroči ortostatsko hipotenzijo, še posebej med začetnim titriranjem odmerka; če se to zgodi, pride v poštev zmanjšanje odmerka ali postopnejše titriranje.
Furthermore, the long-term safety implications of treatment with Seroquel on growth and maturation have not been studied beyond 26 weeks.
Poleg tega niso raziskane dolgoročne varnostne posledice glede rasti in dozorevanja, če zdravljenje z zdravilom Seroquel traja več kot 26 tednov.
- The Committee considered the referral made under article 6(13) Commission Regulation (EC) No 1084/2003, for Seroquel XR and associated names initiated by the MAH (see annex I).
- je odbor proučil napotitev v skladu s členom 6(13) Uredbe Komisije (ES) št. 1084/2003 za zdravilo Seroquel XR in z njim povezana imena, ki jo je sprožil imetnik dovoljenja za promet z zdravilom (glej Dodatek I);
Given the primary central nervous system effects of quetiapine, Seroquel XR should be used with caution in combination with other centrally acting medicinal products and alcohol.
Ker kvetiapin deluje v prvi vrsti na osrednje živčevje, je treba zdravilo Seroquel SR previdno uporabljati v kombinaciji z drugimi centralno delujočimi zdravili in alkoholom.
The two adjunct (add-on) therapy studies, in patients with inadequate response to at least one initial antidepressant showed statistically and clinically relevant effects for quetiapine compared to placebo.
Dve študiji pomožne (dodatne) terapije pri bolnikih z neustreznim odzivom na vsaj en začetni antidepresiv sta pokazali statistično in klinično pomembne učinke kvetiapina v primerjavi s placebom.
- The CHMP recognised that for add-on treatment relevant effects have been demonstrated in patients not responding to at least one antidepressant treatment.
- je CHMP ugotovil, da so bili za dodatno zdravljenje dokazani pomembni učinki pri bolnikih, ki se ne odzivajo na vsaj eno antidepresivno zdravljenje.
Levels of TBG were unchanged and in general, reciprocal increases in TSH were not observed, with no indication that quetiapine causes clinically relevant hypothyroidism.
Koncentracija TBG se ni spremenila in recipročnega zvišanja TSH praviloma niso opažali; ni znakov, da kvetiapin povzroča klinično pomemben hipotiroidizem.
The CHMP agreed that the potential long-term safety concerns could be manageable by updated warnings in the product information and by collection of data in the already ongoing and in new post authorisation safety studies (PASSs) which will be included in the updated Risk Management Plan.
CHMP se je strinjal, da je možno potencialne dolgoročne varnostne pomisleke obvladati s posodobljenimi opozorili v informacijah o zdravilu in z zbiranjem podatkov v tekočih in novih študijah o varnosti po odobritvi (PASS), ki bodo vključeni v posodobljen načrt za obvladovanje tveganja.
Liver problems If you have liver problems your doctor may change your dose.
Težave z jetri Če imate težave z jetri, vam bo zdravnik morda spremenil odmerek.
The CHMP has recommended the granting of the variation of the Marketing Authorisation(s) for which the Summary of Product Characteristics and package leaflet are set out in Annex III for Seroquel XR and associated names (see Annex I) and in accordance to the conditions set out in Annex IV.
CHMP je priporočil odobritev spremembe dovoljenja (dovoljenj) za promet z zdravilom, za katerega sta povzetek glavnih značilnosti zdravila in navodilo za uporabo določena v Dodatku III za zdravilo Seroquel XR in z njim povezana imena (glej Dodatek I) ter v skladu s pogoji, določenimi v Dodatku IV.
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Pack sizes of 10, 30, 50, 60 and 100 tablets are registered for all strengths.
Pakiranja za vse jakosti so 10, 30, 50, 60 in 100 tablet.
Norquetiapine is primarily formed and eliminated via CYP3A4.
Norkvetiapin v prvi vrsti nastaja in se odstranjuje s CYP3A4.
Quetiapine is an atypical antipsychotic agent, which together with its active metabolite - norquetiapine interacts with several neurotransmitter receptors.
Kvetiapin je atipični antipsihotik, ki skupaj s svojim aktivnim metabolitom norkvetiapinom deluje na številne nevrotransmitorne receptorje.
• prevention of recurrence in patients with bipolar disorders, in patients whose maniac or depressive episode has responded to quetiapine treatment.
• preprečevanje ponovitve pri bolnikih z bipolarno motnjo, bolnikih, katerih manična ali depresivna epizode se je odzvala na zdravljenje s kvetiapinom.
(21) See Section 5.1
(21) Glejte poglavje 5.1
Constipation, dyspepsia
zaprtje, dispepsija
Following pregnancies in which quetiapine was used, neonatal withdrawal symptoms were observed.
Ko so sledili nosečnostim, med katerimi so ženske uporabljale kvetiapin, so opažali odtegnitvene simptome pri novorojenčkih.
The short-term efficacy demonstrated in the two add-on studies in patients with inadequate response to initial antidepressant monotherapy treatment balanced positively with the already know safety profile of quetiapine.
Kratkoročna učinkovitost, dokazana v dveh študijah dopolnilnega zdravljenja pri bolnikih z neustreznim odzivom na začetno antidepresivno zdravljenje z monoterapijo, je bila ob že znanem varnostnem profilu kvetiapina pozitivna.
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If any of the following side effects get serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
In a multiple dose trial in patients to assess the pharmacokinetics of quetiapine given before and during treatment with carbamazepine (a known hepatic enzyme inducer), co-administration of carbamazepine significantly increased the clearance of quetiapine.
V preskušanju z več odmerki, narejenega pri bolnikih za oceno farmakokinetike kvetiapina, uporabljenega pred in med zdravljenjem s karbamazepinom (znanim induktorjem jetrnih encimov), je sočasna uporaba karbamazepina pomembno povečala očistek kvetiapina.
Quetiapine has no appreciable affinity at muscarinic or benzodiazepine receptors.
Kvetiapin nima upoštevanja vredne afinitete za muskarinske ali benzodiazepinske receptorje.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Responder rates (YMRS improvement ≥50%) were 64% for Seroquel 400 mg/day, 58% for 600 mg/day and 37% in the placebo arm.
Deleži odzivnih (izboljšanje YMRS za ≥ 50 %) so bili 64 % za Seroquel 400 mg/dan, 58 % za 600 mg/dan in 37 % v kraku s placebom.
Quetiapine treatment was associated with small dose-related decreases in thyroid hormone levels, particularly total T4 and free T4.
Zdravljenje s kvetiapinom je bilo povezano z majhnim, z odmerkom povezanim, znižanjem koncentracije ščitničnih hormonov, zlasti celotnega T4 in prostega T4.
Concomitant use of quetiapine with a strong hepatic enzyme inducer such as carbamazepine or phenytoin substantially decreases quetiapine plasma concentrations, which could affect the efficacy of quetiapine therapy.
Sočasna uporaba kvetiapina z močnim induktorjem jetrnih encimov kot sta karbamazepin ali fenitoin, bistveno zmanjša koncentracijo kvetiapina v plazmi, kar bi lahko neugodno vplivalo na terapijo s kvetiapinom.
As for other antipsychotic agents, the exact mechanism of action of quetiapine is unknown but the combination of receptor antagonism with a higher selectivity for serotonin 5HT2 relative to dopamine D2 receptors may contribute to its psychotropic activity and mood stabilizing properties.
Kot pri drugih antipsihotikih tudi pri kvetiapinu ni natančno znan mehanizem delovanja, vendar lahko kombinacija antagonizma receptorjev z višjo selektivnostjo za serotonin 5HT2 v zvezi z dopaminskimi receptorji D2 prispeva k njegovemu psihotropnemu delovanju in lastnostim stabilizacije razpoloženja.
The CHMP, based on the data available and further to consultation of the clinical neuroscience scientific advisory group (SAG-CNS), considered that efficacy in the therapeutic indication applied by the MAH, i.e., monotherapy in patients with recurrent major depression episodes that cannot be appropriately managed with alternative antidepressants, was not explicitly studied in the performed studies.
CHMP je na podlagi razpoložljivih podatkov in po posvetovanju z Znanstveno svetovalno skupino za klinično nevroznanost (SAG-CNS) menil, da učinkovitost terapevtske indikacije, ki jo je navedel imetnik dovoljenja za promet z zdravilom, tj. monoterapija pri bolnikih s ponavljajočimi se velikimi depresivnimi epizodami, ki jih ni možno ustrezno obvladati z alternativnimi antidepresivi, v izvedenih študijah ni bila nedvoumno proučena.
In an interaction study in healthy volunteers, concomitant administration of quetiapine (dosage of 25 mg) with ketoconazole, a CYP3A4 inhibitor, caused a 5- to 8-fold increase in the AUC of quetiapine.
V študiji medsebojnega delovanja pri zdravih prostovoljcih je sočasna uporaba kvetiapina (v odmerku 25 mg) z zaviralcem CYP3A4 ketokonazolom povzročila od 5- do 8-kratno povečanje AUC kvetiapina.