natgillin/translations-raw huggingface dataset:
Olanzapine Mylan has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Pokazalo se da Olanzapine Mylan sprječava ponavljanje tih simptoma u bolesnika s bipolarnim poremećajem čije su epizode manije reagirale na liječenje olanzapinom.
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Klirens olanzapina u plazmi bio je niži u starijih nego u mlađih ispitanika, u žena nego u muškaraca te u nepušača nego pušača.
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1 %; a potential contributing factor could be high plasma valproate levels.
U jednom kliničkom ispitivanju u bolesnika s bipolarnom manijom, kombinacijska terapija valproata i olanzapina uzrokovala je incidenciju neutropenije od 4,1 %; mogući faktor koji je tome pridonio mogle su biti visoke razine valproata u plazmi.
Olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Terapija olanzapinom započinje dozom od 2,5 mg na dan i titrira se na maksimalno 15 mg na dan na temelju stručne procjene ispitivača.
Very common symptoms in overdose (> 10 % incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Vrlo česti simptomi predoziranja (incidencija > 10 %) obuhvaćaju tahikardiju, agitaciju/agresivnost, dizartriju, različite ekstrapiramidalne simptome te smanjenu razinu svijesti u rasponu od sedacije do kome.
14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l< 1.467 mmol/l) to high (≥ 1.467 mmol/l).
14 Uočeno za normalne početne razine triglicerida natašte (< 1,016 mmol/l) koje su porasle na visoke razine (≥ 1,467 mmol/l) i promjene vrijednosti triglicerida natašte od početnih graničnih vrijednosti (≥ 1,016 mmol/l-< 1,467 mmol/l) do visokih vrijednosti (≥ 1,467 mmol/l).
- The active substance is olanzapine.
- Djelatna tvar je olanzapin.
Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section
tromboembolija (uključujući plućnu emboliju i duboku vensku trombozu) (vidjeti dio 4.4)
Hypothermia12
hipotermija12
What Olanzapine Mylan looks like and contents of the pack
Kako Olanzapine Mylan izgleda i sadržaj pakiranja
The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Primjena olanzapina u liječenju psihoza povezanih s dopaminskim agonistima u bolesnika s Parkinsonovom bolešću se ne preporučuje.
Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.5).
Preporučuje se klinički nadzor, a po potrebi se može razmotriti i povećanje doze olanzapina (vidjeti dio 4.5).
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
Sljedeća tablica sažima nuspojave zabilježene s većom učestalosti u adolescentnih bolesnika (u dobi od 13 do 17 godina) u odnosu na odrasle bolesnike ili nuspojave identificirane samo u kratkotrajnim kliničkim ispitivanjima u adolescentnih bolesnika.
• Weight gain has been seen in patients taking Olanzapine Mylan.
• Opaženo je povećanje tjelesne težine u bolesnika koji uzimaju Olanzapine Mylan.
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Veličine promjena vrijednosti ukupnog kolesterola natašte, LDL kolesterola, triglicerida i prolaktina bile su veće u adolescenata nego u odraslih (vidjeti dijelove 4.4 i 4.8).
- The other ingredients are: (tablet core) lactose monohydrate (see section 2 ‘Olanzapine contains lactose'), maize starch, preglatinised maize starch, crospovidone type A, magnesium stearate and (tablet coating) polyvinyl alcohol, titanium dioxide (E171), talc (E553b), soya lecithin (E322) (see section 2 ‘Olanzapine Mylan contains soya lecithin'), xanthan gum (E415).
- Ostali sastojci su: (jezgra tablete) laktoza hidrat (pogledajte 2. odjeljak „Olanzapine sadrži laktozu”), kukuruzni škrob, prethodno gelirani kukuruzni škrob, krospovidon tipa A, magnezijev stearat i (ovojnica tablete) polivinilni alkohol, titanijev dioksid (E171), talk (E553b), sojin lecitin (E322) (pogledajte 2. odjeljak „Olanzapine Mylan sadrži sojin lecitin”), ksantanska guma (E415).
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Mogući utjecaj olanzapina na druge lijekove Olanzapin može antagonistički djelovati na učinke izravnih i neizravnih agonista dopamina.
Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Ispitivanja ponašanja životinja koje su primale olanzapin ukazivala su na antagonizam s 5HT, dopaminom i kolinergicima u skladu s profilom vezanja na receptore.
However, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
No potreban je oprez ako se olanzapin uzima uz lijekove za koje je poznato da produljuju QTc interval, osobito u starijih bolesnika, u bolesnika s prirođenim dugim QT sindromom, kongestivnim zatajenjem srca, hipertrofijom srca, hipokalemijom ili hipomagnezijemijom.
Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Dokazano je da fluvoksamin, specifični inhibitor CYP1A2, značajno inhibira metabolizam olanzapina.
Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
S obzirom na učinak olanzapina na središnji živčani sustav potreban je oprez ako se koristi u kombinaciji s ostalim lijekovima sa središnjim djelovanjem te alkoholom.
Standard procedures for management of overdose may be indicated (i.e. gastric lavage, administration of activated charcoal).
Mogu biti indicirani standardni postupci liječenja predoziranja (npr. ispiranje želuca, primjena aktivnog ugljena).
Increased alkaline phosphatase10
povišena alkalna fosfataza10
In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % vs. 1.5 %, respectively).
U placebom kontroliranim kliničkim ispitivanjima (trajanja od 6 do 12 tjedana) starijih bolesnika (srednja vrijednost dobi 78 godina) s psihozom i/ili poremećajima ponašanja uzrokovanih demencijom zabilježeno je dvostruko povećanje incidencije smrtnosti u bolesnika liječenih olanzapinom u usporedbi s bolesnicima liječenim placebom (3,5 % u odnosu na 1,5 %).
In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
U ispitivanjima usporednih skupina u trajanju do godinu dana ili kraće, olanzapin je bio povezan sa statistički značajno nižom incidencijom diskinezije koja se javlja s liječenjem.
• Liver or kidney disease
• Bolest jetre ili bubrega
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2 % of overdose cases) and cardiopulmonary arrest.
Druge medicinski značajne posljedice predoziranja obuhvaćaju delirij, konvulzije, komu, mogući neuroleptički maligni sindrom, respiratornu depresiju, aspiraciju, hipertenziju ili hipotenziju, srčane aritmije (< 2 % slučajeva predoziranja) i kardiopulmonalni arest.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
U kliničkim ispitivanjima u bolesnika s psihozom uzrokovanom lijekom (agonisti dopamina) povezanom s Parkinsonovom bolesti, vrlo često je zabilježeno pogoršanje simptoma parkinsonizma i halucinacija i češće nego s placebom.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Ako imate dodatna pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
Patients with known risk of narrow-angle glaucoma.
Bolesnici s poznatim rizikom za glaukom oštrog kuta.
In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
U mladunčadi štakora kojima je davan olanzapin primijećeni su zastoj u fetalnom razvoju i prolazno smanjenje razina aktivnosti.
In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30 % of olanzapine treated patients with normal baseline prolactin value.
8 U kliničkim ispitivanjima u trajanju do 12 tjedana, koncentracije prolaktina u plazmi prelazile su gornju granicu normalnog raspona u približno 30 % bolesnika liječenih olanzapinom s normalnom početnom vrijednosti prolaktina.
Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Budući da se olanzapin metabolizira preko CYP1A2, tvari koje mogu specifično inducirati ili inhibirati taj izoenzim mogu utjecati na farmakokinetiku olanzapina.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1 % to 1 %) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
U kliničkim ispitivanjima, klinički značajna produljenja QTc (Fridericia QT korekcija [QTcF] ≥ 500 milisekundi [msek] bilo kada nakon početne vrijednosti u bolesnika s početnom vrijednošću QTcF < 500 milisekundi) bila su manje česta (0,1 % do 1 %) u bolesnika liječenih olanzapinom, bez značajnih razlika u povezanim kardijalnim događajima u usporedbi s placebom.
Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Redovito treba pratiti tjelesnu težinu, npr. na početku te nakon 4, 8 i 12 tjedana nakon početka liječenja olanzapinom te svaka 3 mjeseca nakon toga.
Clinical signs included sedation, ataxia, tremors, increased heart rate, laboured respiration, miosis, and anorexia.
Klinički znakovi uključivali su sedaciju, ataksiju, tremore, ubrzani rad srca, otežano disanje, miozu i anoreksiju.
SPECIAL STORAGE CONDITIONS Do not store above 25C.
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25 °C.
Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Reverzibilni učinci sukladni s porastom prolaktina u štakora uključivali su smanjenje težine jajnika i maternice te morfološke promjene epitela rodnice i mliječnih žljezda.
Anticholinergic activity
Antikolinergičko djelovanje
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
U ispitivanju na zdravim dojiljama, olanzapin se izlučivao u majčino mlijeko.
If you suddenly stop taking Olanzapine Mylan, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Ako naglo prestanete s uzimanjem Olanzapine Mylan mogu se pojaviti simptomi poput znojenja, nesanice, drhtanja, tjeskobe ili mučnine i povraćanja.
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
U bolesnika koji su primali olanzapin za liječenje manične epizode, nastavite terapiju istom dozom za sprječavanje relapsa.
There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Prijavljeni su osjećaj nemira, hipertonija, hipotonija, tremor, nesanica, respiratorni distres i poremećaj u hranjenju.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychoticand risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Osim toga, ispitivanje jednofotonskom emisijskom računalnom tomografijom (SPECT, engl. single photon emission computed tomography) snimanja u bolesnika sa shizofrenijom otkrila su da bolesnici koji reagiraju na olanzapin imaju manju zauzetost strijatalnih D2 receptora od bolesnika koji su reagirali na neke druge antipsihotike i risperidon, dok je zauzetost bila usporediva s onom u bolesnika koji su reagirali na klozapin.
In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see section 4.4).
U kliničkim ispitivanjima u starijih bolesnika s demencijom, liječenje olanzapinom bilo je povezano s povišenom incidencijom smrti i cerebrovaskularnih nuspojava u odnosu na placebo (vidjeti dio 4.4).
Haematologic toxicity
Hematološka toksičnost
12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95 % confidence interval utilising the Olanzapine Integrated Database.
12 Štetni događaj identificiran iz spontanih izvješća nakon stavljanja lijeka u promet s učestalošću koja je procijenjena na gornju granicu 95-postotnog intervala pouzdanosti upotrebom integrirane baze podataka za olanzapin.
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Vrlo česte nuspojave povezane s primjenom olanzapina u ovoj skupini bolesnika bile su poremećen hod i padanje.
Decreased bioavailability
Smanjena bioraspoloživost
Olanzapine is not indicated for use in the treatment of children and adolescents.
Olanzapin nije indiciran za primjenu u liječenju djece i adolescenata.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Svi bolesnici koji su liječeni olanzapinom i placebom u kojih se javio cerebrovaskularni događaj, prethodno su imali čimbenike rizika.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Nije utvrđena uzročna povezanost između pojave venske tromboembolije i liječenja olanzapinom.
You should swallow the Olanzapine Mylan tablets whole with water.
Olanzapine Mylan tablete progutajte cijele s vodom.
10 As assessed by measured values from clinical trials in the Olanzapine Integrated Database.
10 Prema procjeni izmjerenih vrijednosti iz kliničkih ispitivanja u integriranoj bazi podataka za olanzapin.
Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Znakovi oralne toksičnosti u glodavaca bili su karakteristični za snažne neuroleptičke spojeve: hipoaktivnost, koma, tremor, kloničke konvulzije, salivacija te smanjena tjelesna težina.
The most frequently (seen in ≥ 1 % of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Najčešće zabilježene nuspojave (uočene u ≥ 1 % bolesnika) povezane s primjenom olanzapina u kliničkim ispitivanjima bile su somnolencija, povećanje tjelesne težine, eozinofilija, povišene vrijednosti prolaktina, kolesterola, glukoze i triglicerida (vidjeti dio 4.4), glukozurija, povećan apetit, omaglica, akatizija, parkinsonizam, leukopenija, neutropenija (vidjeti dio 4.4), diskinezija, ortostatska hipotenzija, antikolinergički učinci, prolazni asimptomatski porast razina jetrenih aminotransferaza (vidjeti dio 4.4), osip, astenija, umor, pireksija, artralgija, povišena alkalna fosfataza, povišena gamaglutamiltransferaza, povišena mokraćna kiselina, povišena kreatin fosfokinaza i edemi.
Patients treated with any antipsychotic medicines, including olanzapine, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
U bolesnika liječenih bilo kojim antipsihotikom, uključujući olanzapin, potrebno je redovito pratiti razinu lipida prema smjernicama korištenih antipsihotika, na primjer, na početku liječenja, 12 tjedana nakon početka liječenja olanzapinom te svakih 5 godina nakon toga.
6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
6 U kliničkim ispitivanjima incidencija parkinsonizma i distonije u bolesnika liječenih olanzapinom bila je brojčano veća, ali nije bila statistički znatno različita u odnosu na placebo.
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Tijekom liječenja olanzapinom, u adolescenata je primijećen veći porast tjelesne težine u usporedbi s odraslim osobama.
Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
Ostali simptomi mogu biti: akutna smetenost, napadaji (epilepsija), koma, kombinacija vrućice, ubrzanog disanja, znojenja, ukočenosti mišića i omamljenosti ili pospanosti, usporavanje disanja, aspiracija, visoki krvni tlak ili niski krvni tlak, poremećaj srčanog ritma.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo models.
Olanzapin je in vitro pokazao veći afinitet za serotoninske 5HT2 nego dopaminske D2 receptore te veće djelovanje na 5 HT2 nego D2 u in vivo modelima.
Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Olanzapin nije indiciran za liječenje djece i adolescenata mlađih od 18 godina.
Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines, e.g. measuring of blood glucose at baseline, 12 weeks after starting olanzapine treatment and annually thereafter.
Savjetuje se odgovarajuće kliničko praćenje bolesnika u skladu s važećim smjernicama korištenja antipsihotika, na primjer redovito mjerenje početne vrijednosti glukoze u krvi 12 tjedana nakon početka liječenja olanzapinom te jednom godišnje nakon toga.
9 Adverse event identified from clinical trials in the Olanzapine Integrated Database.
9 Štetni događaj identificiran iz kliničkih ispitivanja u integriranoj bazi podataka za olanzapin.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
U ispitivanju istodobne terapije u bolesnika liječenih litijem ili valproatom tijekom najmanje 2 tjedna, dodavanje 10 mg olanzapina (istodobna terapija litijem ili valproatom), rezultiralo je većim smanjenjem simptoma manije nego monoterapija litija ili valproata nakon 6 tjedana.
Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).
Vremenska povezanost liječenja olanzapinom i venske tromboembolije (VTE) zabilježena je manje često (< 0,01 % i < 1 %).
What Olanzapine Mylan contains
Što Olanzapine Mylan sadrži
In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/hr).
U bolesnika s oštećenjem bubrega (klirens kreatinina < 10 ml/min) nije bilo značajne razlike u odnosu na zdrave ispitanike u srednjoj vrijednosti poluvremena eliminacije (37,7 u odnosu na 32,4 sata) ili klirensu (21,2 u odnosu na 25,0 l/sat).
BOTTLE LABEL AND CARTON LABEL
OZNAČAVANJE NA BOCI I KUTIJI
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Dodatni znakovi mogu obuhvaćati povišenu kreatin fosfokinazu, mioglobinuriju (rabdomiolizu) te akutno zatajenje bubrega.
Olanzapine-treated patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Bolesnici liječeni olanzapinom imali su nižu incidenciju parkinsonizma, akatizije i distonije u usporedbi s titriranim dozama haloperidola.
Bottles:
Boce::
The exact amount is shown on your Olanzapine Mylan tablet pack.
Točna količina navedena je na pakiranju tableta Olanzapine Mylan.
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
2 Prosječni porast vrijednosti lipida natašte (ukupni kolesterol, LDL kolesterol i trigliceridi) bio je veći u bolesnika bez dokazane disregulacije lipida na početku.
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 Akutni simptomi kao što su znojenje, nesanica, tremor, anksioznost, mučnina i povraćanje zabilježeni su prilikom naglog prekida primjene olanzapina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNURAŠNJA KUTIJA MULTIPAKIRANJA (BEZ PLAVE KUTIJE)
A small study of the effect of impaired liver function in 6 subjects with clinically significant (Childs Pugh Classification A (n = 5) and B (n = 1)) cirrhosis revealed little effect on the pharmacokinetics of orally administered olanzapine (2.5 - 7.5 mg single dose): Subjects with mild to moderate hepatic dysfunction had slightly increased systemic clearance and faster elimination half-time compared to subjects with no hepatic dysfunction (n = 3).
Malo ispitivanje utjecaja oštećene funkcije jetre, provedeno u 6 ispitanika s klinički značajnom (Child Pugh A (n = 5) i B (n = 1)) cirozom, pokazalo je mali učinak na farmakokinetiku peroralno primijenjenog olanzapina (jedna doza od 2,5 - 7,5 mg): ispitanici s blagom do umjerenom disfunkcijom jetre imali su blago povišen sistemski klirens i brže poluvrijeme eliminacije u usporedbi s ispitanicima koji nisu imali disfunkciju jetre (n = 3).
In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
U bolesnika s manijom ili miješanim epizodama bipolarnog poremećaja, olanzapin je pokazao superiornu djelotvornost u odnosu na placebo i valproat seminatrij (divalproeks) u smanjenju simptoma manije tijekom 3 tjedna.