natgillin/translations-raw huggingface dataset:
Pharmacotherapeutic group: antipsychotics: diazepines, oxazepines and thiazepines, ATC code:
Farmakoterapeutická skupina: antipsychotiká, diazepíny, oxazepíny a tiazepíny, ATC kód:
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Olanzapín je antipsychotická, antimanická a náladu stabilizujúca látka, ktorá vykazuje š iroký profil farmakologických úč inkov na viaceré receptorové systémy.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α adrenergic; and histamine H1 receptors.
V predklinických š túdiách preukázal olanzapín afinitu k radu receptorov (Ki; < 100 nM) - k serotonínovým 5HT2A/ 2C, 5HT3, 5HT6; dopamínovým D1, D2, D3, D4, D5; cholinergným muskarínovým m1- m5; α
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
zvieratách preukázali antagonistické pôsobenie olanzapínu na 5HT, dopamínové a cholínergné receptory, č je v súlade s väzbovým profilom látky.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Olanzapín vykazoval in vitro väčiu afinitu k š o š serotonínovým 5HT2 receptorom než dopamínovým D2 a vyš 5HT2 ako D2 aktivitu na in vivo
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Olanzapín zniž podmienenú reakciu úniku, č je test na zistenie
Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
antipsychotického úč inku, v dávkach, ktoré eš nevyvolávajú katalepsiu, úč naznač motorické vedľ ie úč
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
reaktivitu v „ anxiolytickom “ teste.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
V š s jednorazovou perorálnou dávkou (10 mg) a sledovaním pomocou pozitrónovej emisnej túdii tomografie (PET) u zdravých dobrovoľ níkov obsadzoval olanzapín viac 5HT2A receptory ako dopamínové D2 receptory.
In addition, a SPECT imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
na olanzapín nižia ako u pacientov odpovedajúcich na iné antipsychotiká a risperidón, zatiaľ o u pacientov odpovedajúcich na klozapín bola porovnateľná.
In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
V medzinárodnej, dvojito zaslepenej, porovnávacej š zahŕajúcej 1 481 pacientov so ň túdii schizofréniou, schizoafektívnymi a príbuznými poruchami a s rôznymi stupň pridruž
In a multinationational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
depresívnych symptómov (priemerné východiskové skóre 16, 6 š MADRS / the Montgomery - kály Asberg Depression Rating Scale /) preukázala prospektívna sekundárna analýza zmenu skóre od východiskovej po koneč hodnotu š
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 pacientov s manickou alebo zmieš anou epizódou bipolárnej poruchy preukázal olanzapín v zníž ení š innosť placebo a valproát semisodium (divalproex). manických symptómov za 3 týž vyš úč
Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Olanzapín taktiežpreukázal porovnateľ úč nú innosť haloperidolom v zmysle podielu pacientov v s symptomatickej remisii mánie a depresie po 6 a 12 týž och.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition
V š kombinovanej terapie u
11 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.
pacientov liečených lítiom alebo valproátom po dobu minimálne 2 týž viedlo pridanie olanzapínu v dne š dávke 10 mg (v kombinácii s lítiom alebo valproátom) ku väčej redukcii symptómov mánie ako tomu bolo pri lieč lítiom alebo valproátom v rámci monoterapie za 6 týž ov.
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
V 12- mesač š prevencie rekurencie u pacientov s manickou epizódou, ktorí dosiahli remisiu pri nej túdii lieč olanzapínom a boli potom randomizovaní na už be ívanie olanzapínu alebo placeba, preukázal olanzapín vočplacebu v primárnom koncovom bode rekurencie bipolárnej poruchy š
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recur rence into mania or recurrence into depression.
V druhej 12- mesač š prevencie rekurencie u pacientov s manickou epizódou, ktorí dosiahli nej túdii remisiu pri lieč kombináciou olanzapínu a lítia a boli potom randomizovaní na už
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
olanzapínu alebo lítia, nebol olanzapín v primárnom koncovom bode rekurencie bipolárnej poruchy štatisticky podradený vočlítiu (olanzapín 30, 0%, lítium 38, 3%; p = 0, 055). i
In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
bipolárnej poruchy definovanej podľ syndrómových (diagnostických) kritérií. a
Paediatric population The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Pediatrická populácia Skúsenosti s mladistvými (vo veku 13 až rokov) sú obmedzené na údaje o krátkodobej úč prípade schizofrénie (6 týž ov) a mánie
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
zahŕali menej ako 200 mladistvých.
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Poč lieč olanzapínom sa zvýš hmotnosť mladistvých podstatne viac ako
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.
Nie sú k dispozícii údaje š
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
nosti sú obmedzené (pozri č 4. 4 a 4. 8).
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Olanzapín sa po perorálnom podaní dobre vstrebáva a dosahuje maximálne plazmatické koncentrácie za 5 až hodín.
Absolute oral bioavailability relative to intravenous administration has not been determined.
Absolútna perorálna biologická dostupnosť 8 vo vzť k intravenóznemu podaniu nebola stanovená. ahu
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Olanzapín sa metabolizuje v peč konjugáciou a oxidáciou.
The major circulating metabolite is the 1 0-N-glucuronide, which does not pass the blood brain barrier.
Hlavným metabolitom v obehu je 10- N - eni glukuronid, ktorý neprestupuje hematoencefalickou bariérou.
Cytochromes P450- CYP 1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Cytochrómy P450- CYP1A2 a P450 - CYP2D6 prispievajú k tvorbe metabolitov N- desmetylu a 2- hydroxymetylu, vykazujúcich in vivo významne nižiu farmakologickú aktivitu ako olanzapín v š
The predominant pharmacologic activity is from the parent olanzapine.
Prevaž č ná asť
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Po perorálnom podaní, priemerný terminálny polč vyluč
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
U zdravých starš jedincov (nad 65 rokov) sa v porovnaní s mladš jedincami priemerný polč
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
vyluč ovania predĺ (51, 8 oproti 33, 8 hod) a klírens sa zníž (17, 5 oproti 18, 2 l/ hod).
In 44 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
U 44 schizofrenických pacientov starš ako 65 rokov sa pri dávkach 5- 20 mg/ deň ích nepozoroval zvýš výskyt než
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/ hr).
Napriek tomu vykazoval olanzapín (5- 20 mg) porovnateľ
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
nostný profil tak u ž (n=467) ako aj u muž (n=869).
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 pacientov s poš kodením funkcie oblič (klírens kreatinínu < 10 ml/ min) v porovnaní so zdravými iek jedincami nespôsobovala významný rozdiel priemerného polč eliminácie (37, 7 oproti 32, 4 hod) asu alebo klírensu (21, 2 oproti 25, 0 l/ hod).
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Štúdia rovnováhy ukázala, ž približ 57% olanzapínu
12 In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
e
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
ne
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
označ eného rádioaktívnym izotopom sa vyluč do moč vo forme metabolitov.
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
U fajč
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
13
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
iarov s miernym poš kodením peč v porovnaní so zdravými nefajč
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
vylučovania (39, 3 hod) predĺ a klírens (18, 0 l/ hod) sa zníž (48, 8 hod resp.
1
14, 1 l/ hod).
Paediatric population Adolescents (ages 13 to 17 years):
Mladiství (vek 13 až rokov):
The pharmacokinetics of olanzapine are similar between adolescents and adults.
17 V klinických š
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
túdiách bola priemerná expozícia olanzapínu približ o 27% vyšia u mladistvých. ne
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Demografické rozdiely medzi mladistvými a dospelými zahŕali a menšpoč fajč
Such factors possibly contribute to the higher average exposure observed in adolescents.
Tieto faktory mož
5.3 Preclinical safety data
pozorovanej u mladistvých.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
hypoaktivitu, kómu, tras, klonické kŕe, slinenie a pokles telesnej hmotnosti.
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Stredná letálna dávka u myšbola 210 mg/ kg a u krýs 175 mg/ kg.
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Psi tolerovali jednorazovú dávku až 100 mg/ kg s í do nulovou mortalitou.
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Medzi klinické príznaky patril útlm, ataxia, tras, zrýchlený pulz, sť ené až dýchanie, mióza a anorexia.
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
U opíc vyvolala jednorazová perorálna dávka do 100 mg/ kg vyč a vyš dávky č š ie iastoč bezvedomie. né
Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Toxicita po opakovanom podaní Medzi hlavné prejavy toxicity pozorované v 3- mesač šnej túdii u myša 1- roč š u potkanov a í nej túdii psov patril útlm CNS, anticholínergné úč a ochorenia periférnej krvi.
Tolerance developed to the CNS depression.
Na útlm CNS sa vyvinula inky tolerancia.
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.
hladinou prolaktínu u krýs zahŕali pokles hmotnosti ovárií a uteru a morfologické zmeny vaginálneho epitelu a prsných ž liaz.
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
U vš etkých druhov boli pozorované úč na hematologické ukazovatele, inky vrátane na dávke závislom poklese poč leukocytov v krvi u myša neš
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
loveku), sa vyvinula reverzibilná neutropénia, trombocytopénia
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
U psov s cytopéniou sa nepozorovali ž iadne nepriaznivé úč na progenitorové a inky proliferujúce bunky kostnej drene.
Reproductive toxicity Olanzapine had no teratogenic effects.
Reprodukč toxicita ná Olanzapín nemá ž iadne teratogénne úč inky.
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
Estrálne cykly boli ovplyvnené dávkou 1, 1 mg/ kg (č je 3- násobok maximálnej o dávky u človeka) a reprodukč parametre boli u potkanov ovplyvnené dávkou 3 mg/ kg (č je 9 -
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
pozorovalo oneskorenie fetálneho vývoja a prechodný pokles aktivity.
13 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
testov bakteriálnych mutácií in vivo a in vitro testov na cicavcoch.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Karcinogenita Na základe výsledkov š na myš a potkanoch sa zistilo, ž olanzapín nie je karcinogénny.
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
Monohydrát laktózy Prášková celulóza elatinovaný kukurič š Predž ný krob Kukurič š ný krob Koloidný oxid kremič bezvodý itý Magnéziumstearát
6.3 Shelf life
Č použ nosti 6. 3 as iteľ
6.4 Special precautions for storage
Š 6. 4 peciálne upozornenia na uchovávanie
This medicinal product does not require any special storage conditions.
iadne zvláš podmienky na uchovávanie. tne
Blister pack (OPA/ Al/ PVC, Al-foil):
Blistrové balenie (OPA/ AL/ AVC, AL fólia):
14, 28, 35, 56 or 70 tablets in a box.
14, 28, 35, 56 alebo 70 tabliet v š katuľ ke.
6.6 Special precautions for disposal
zlikvidovaný v súlade s miestnymi
Any unused product or waste material should be disposed of in accordance with local requirements.
požiadavkami.
MARKETING AUTHORISATION HOLDER
DRŽITEĽROZHODNUTIA O REGISTRÁCII
MARKETING AUTHORISATION NUMBER(S)
NÉ ÍSLA
9.
Ž 9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DÁTUM PRVEJ REGISTRÁCIE / PREDĹ ENIA REGISTRÁCIE
27 September 2007.
27. 9. 2007.
14 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobné informácie o tomto lieku sú dostupné na internetovej stránke Európskej liekovej agentúry (EMEA) http: // www. emea. europa. eu /.
Each tablet contains 5 mg olanzapine.
Kaž tableta obsahuje 5 mg olanzapínu. dá
Each tablet contains 80.9 mg lactose.
Kaž tableta obsahuje 80, 9 mg laktózy. dá Úplný zoznam pomocných látok, pozri č 6. 1. asť
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 5”.
Tablety sú okrúhle, mierne bikonvexné, slabož tablety s mož ou ojedinelých ž ltých š n a s nápisom “ 5 ”.
16 Olanzapine can be given without regards for meals as absorption is not affected by food.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
Gradual tapering of the dose should be considered when discontinuing olanzapine.
ovanie dávky.
Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Olanzapín sa neodporúč použ u detí a mladistvých vo veku do 18 rokov kvôli nedostatoč
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
Vyš stupeňprírastku na hmotnosti, zmien lipidov a prolaktínu boli í hlásené v krátkodobých š
Elderly A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see also section 4.4).
Starší š Podanie nižej poč nej dávky (5 mg/ deň nie je zvyč indikované, avš má sa zváž u
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
niekoľ dní až dň kým dôjde k zlepš klinického ko týž ov, eniu
17 with olanzapine compared to patients treated with placebo (1.3% vs.
bol v porovnaní s pacientami užívajúcimi placebo 3- násobný nárast CVAE (1, 3% vs.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
18 U vš etkých pacientov lieč ených olanzapínom alebo placebom, u ktorých sa vyskytla cerebrovaskulárna príhoda, boli už predtým prítomné rizikové faktory.
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Parkinsonova choroba Neodporúč sa použ olanzapínu na lieč psychózy súvisiacej s podávaním dopamínového
Rare cases reported as NMS have also been received in association with olanzapine.
NMS je potenciálne ž ohrozujúci stav, ktorý sa objavil v súvislosti s podávaním antipsychotík. ivot Zriedkavé prípady označ ako NMS sa rovnako vyskytli v súvislosti s olanzapínom.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Klinické ené prejavy NMS sú hyperpyrexia, svalová rigidita, zmenený duš
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Ď ími alš príznakmi môž byť
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
u
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
zvýš hladina kreatinínfosfokinázy, myoglobinúria (rabdomyolýza) a akútne ená
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Ak sa u pacienta vyvinú znaky a príznaky, ktoré naznač prítomnosť
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
NMS, alebo
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
ak má vysokú horúč nevysvetleného pôvodu bez ď ích klinických známok NMS, musia sa
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
vysadiť etky antipsychotiká vrátane olanzapínu. vš
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Hyperglykémia a diabetes Zriedkavo bola hlásená hyperglykémia a/ alebo exacerbácia preexistujúceho diabetu, prílež itostne spojená s ketoacidózou alebo kómou, v niekoľkých prípadoch vedúcou aj k úmrtiam pacientov (pozri č 4. 8).
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
V niektorých prípadoch tomu predchádzalo zvýš telesnej hmotnosti, č mohlo byť asť
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
predispozič faktorom.