natgillin/translations-raw huggingface dataset:
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
diagnostikuje hepatitída (vrátane hepatocelulérnej, cholestatickej alebo neurč itého poškodenia peč ene), musí sa lieč olanzapínom ukonč.
Skin and subcutaneous tissue disorders
ba
Rash
iť
Photosensitivity reaction Alopecia
Opatrnosť potrebná u pacientov so zníž
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
eným poč
High creatine phosphokinase Increased total bilirubin
leukocytov a/ alebo neutrofilov z akéhokoľ tom
Increased alkaine phosphatase
vek
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
ívajúcich lieky, o ktorých je známe, ž spôsobujú neutropéniu, u pacientov s dôvodu, u pacientov už
15% of baseline body
e
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
anamnézou liekmi navodeného útlmu/ toxicity kostnej drene alebo útlmom kostnej drene spôsobeným súbež ochorením, radiač terapiou alebo chemoterapiou a u pacientov s hypereozinofíliou alebo
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
s myeloproliferatívnou chorobou.
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
Neutropénia bola č hlásená pri súbež už valproátu (pozri č 4. 8). asť
In most patients, levels returned to normal ranges without cessation of treatment.
nom ívaní olanzapínu a
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Pri náhlom ukonč lieč olanzapínom boli veľ zriedkavo (< 0, 01%) hlásené akútne príznaky ako
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
mi
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
potenie, nespavosťtras, úzkosťnevoľ alebo vracanie.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’ s disease, worsening of Parkinsonian symptomatology and ha llucinations were reported very commonly and more frequently than with placebo.
QT interval
Speech disorder was also reported commonly.
V klinických š
During treatment with olanzapine in combination with lithium or divalproex, an increase of  7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
túdiách bolo u pacientov lieč ených olanzapínom klinicky významné predĺ enie intervalu (korekcia QT podľ Fridericii [QTcF] ≥ milisekúnd [msec] kedykoľ po vstupnom
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of  from baseline body weight in 39.9% of 7% patients.
500
65 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
vek
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
etrení u pacientov so vstupnou hodnotou QTcF < 500 msec) menej č (0, 1% až vyš
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
asté
Very common (≥ 10%), common (≥ 1% and < 10%).
1%), bez
Metabolism and nutrition disorders Very common:
signifikantných rozdielov v sprievodných kardiálnych príhodách v porovnaní s placebom.
Weight gain9, elevated triglyceride levels10, increased appetite.
Tak ako u ostatných antipsychotík, je vš potrebná opatrnosťak sa olanzapín predpisuje s liekom
11 Common:
ak
Elevated cholesterol levels Nervous system disorders Very common:
predlž ujúcim QTc interval, najmä u starš pacientov, u pacientov s vrodeným ích ž syndrómom predĺ
Sedation (including: hypersomnia, lethargy, somnolence).
eného QT, s kongestívnou srdcovou nedostatoč ou, hypertrofiou srdca, nosť
Gastrointestinal disorders Common:
hypokaliémiou alebo
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
hypomagneziémiou.
Investigations Very common:
Tromboembólia
With long-term exposure (at least 24 weeks), approximately half of adolescent patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
Č asová súvislosť by olanzapínom a venóznej tromboembólie (VTE) bola hlásená veľ zriedkavo
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
mi
4.9 Overdose
(0, 01%).
Signs and symptoms 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.
inná
Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of 1,500 mg.
medzi výskytom venóznej tromboembólie a lieč olanzapínom nebola bou
Induction of emesis is not recommended.
stanovená.
Standard procedures for management of overdose may be indicated (i. e. gastric lavage, administration of activated charcoal).
Napriek tomu, keď e sú u pacientov so schizofréniou č prítomné získané rizikové
The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
asto
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta- agonist activity since beta stimulation may worsen hypotension.
faktory venóznej tromboembólie, je nutné brať úvahy vš mož rizikové faktory VTE, napr. imobilizácia pacientov, a vykonaťpreventívne
Cardiovascular monitoring is necessary to detect possible arrhythmias.
do opatrenia.
Close medical supervision and monitoring should continue until the patient recovers.
etky
5.
né
5.1 Pharmacodynamic properties
Celkový úč na CNS inok
Pharmacotherapeutic group: antipsychotics: diazepines, oxazepines and thiazepines, ATC code:
Vzhľ adom na primárny úč olanzapínu na CNS je potrebná opatrnosť súbež už
N05AH03.
nom ívaní
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
s inými centrálne pôsobiacimi liekmi čalkoholom.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Pretož pôsobí in vitro ako dopamínový
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.
i
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.
e
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.
antagonista, môž olanzapín antagonizovať inky priamych a nepriamych agonistov dopamínu.
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).
e
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.
úč
67 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.
Záchvaty
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recur rence into mania or recurrence into depression.
Olanzapín sa má použ opatrne u pacientov so záchvatmi v anamnéze alebo u tých, ktorí sú ívať vystavení faktorom, ktoré môž zniž
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).
u
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.
ovať š
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
U pacientov lieč ených olanzapínom boli
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
záchvaty hlásené zriedkavo.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
Vo väčine týchto prípadov boli v anamnéze prítomné záchvaty alebo iné rizikové faktory.
5.2 Pharmacokinetic properties
Tardívna dyskinéza V roč
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
ných alebo kratš porovnávacích š ích
The absorption is not affected by food.
túdiách bol olanzapín š
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
tatisticky významne menej
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.
spojený so vznikom dyskinézy vyvolanej lieč Napriek tomu riziko tardívnej dyskinézy pri bou. dlhodobom už ívaní narastá, a preto, ak sa u pacienta, ktorý je lieč olanzapínom, objavia znaky ený alebo príznaky tardívnej dyskinézy, má sa zváž zníž dávky alebo vysadenie lieč Tieto
The predominant pharmacologic activity is from the parent olanzapine.
prechodne zhorš alebo aj objaviť
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
by.
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 ích pacientov starš ako 65 rokov sa, tak ako u ostatných antipsychotík, odporúč pravidelne merať krvný tlak.
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
ích
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).
a
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Š preukázali rozlič než
68 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).
bu
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).
túdie s pacientami vo veku 13- 17 rokov
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
né
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
iaduce reakcie, vrátane zvýš telesnej hmotnosti, zmien metabolických enia
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
parametrov a zvýš hladín prolaktínu.
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
Dlhodobé výsledky súvisiace s týmito udalosť neboli skúmané a teda nie
1
enia sú známe (pozri č 4. 8 a 5. 1). asti
The pharmacokinetics of olanzapine are similar between adolescents and adults.
65 Tablety Zalasta obsahujú laktózu.
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Pacienti so zriedkavými dedič nými problémami galaktózovej intolerancie, Lappovej deficiencie laktázy alebo malabsorpcie glukózo- galaktózy nemajú už tento ívať liek.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
4. 5 Liekové a iné interakcie
Such factors possibly contribute to the higher average exposure observed in adolescents.
Interakč š né túdie sa uskutoč len u dospelých. nili
5.3 Preclinical safety data
Mož interakcie ovplyvň
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.
adom na fakt, ž olanzapín je metabolizovaný izoenzýmom CYP1A2, látky, ktoré môž Vzhľ
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
špecificky indukovať alebo inhibovať tento izoenzým, môž ovplyvniť
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
farmakokinetiku olanzapínu.
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
metabolizmus olanzapínu, č môž následne viesť Fajč a karbamazepín môž indukovať zníž
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
enie koncentrácie olanzapínu. eniu
Tolerance developed to the CNS depression.
u Pozorovali sa zanedbateľ prípadne len né,
Growth parameters were decreased at high doses.
o e mierne zvýš hodnoty ené
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.
ku
Haematologic toxicity:
klírensu olanzapínu.
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).
Hoci klinický dopad je pravdepodobne minimálny, odporúč sa klinické a monitorovanie a v nevyhnutných prípadoch je mož zváž zvýš dávok olanzapínu (pozri č 4. 2).
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Inhibícia CYP1A2 Preukázalo sa, ž fluvoxamín, š
Reproductive toxicity Olanzapine had no teratogenic effects.
pecifický inhibítor CYP1A2, významne spomaľ
Sedation affected mating performance of male rats.
olanzapínu.
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).
Priemerné zvýš maximálnej koncentrácie (Cmax) olanzapínu fluvoxamínom bolo enie 54% u ž nefajč
69 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.
ien
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
iarok a 77% u muž fajč
6.
ov
PHARMACEUTICAL PARTICULARS
Priemerné zvýš
6.1 List of excipients
plochy pod krivkou enie
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
už ívajúcich fluvoxamín, prípadne iný inhibítor CYP1A2, ako napr. ciprofloxacín, sa má zvážiť zníž poč nej dávky olanzapínu.
6.2 Incompatibilities
iť enie
Not applicable.
dávok olanzapínu.
6.3 Shelf life
uje
2 years.
má už minimálne 2 hodiny pred, resp. po podaní olanzapínu. ívať
6.4 Special precautions for storage
Mož ovplyvnenie úč iných liekov olanzapínom
This medicinal product does not require any special storage conditions.
Olanzapín môž antagonizovať inky priamych a nepriamych agonistov dopamínu.
6.5 Nature and contents of container
úč
Blister pack (OPA/ Al/ PVC, Al-foil):
Olanzapín in vitro neinhibuje hlavné izoenzýmy CYP450 (napr.
14, 28, 35, 56 or 70 tablets in a box.
1A2, 2D6, 2C9, 2C19, 3A4). akávajú sa preto žiadne osobitné interakcie, č dokazujú aj in vivo š Ne
Not all pack sizes may be marketed.
túdie, ktoré nepreukázali
6.6 Special precautions for disposal
Olanzapín nevykazoval ž iadnu interakciu so súbež podávaným lítiom alebo biperidenom. ne
Any unused product or waste material should be disposed of in accordance with local requirements.
Monitorovanie terapeutických plazmatických hladín valproátu neukázalo, ž by pri zač prídavnej medikácie olanzapínom bola pož adovaná úprava dávkovania valproátu.
MARKETING AUTHORISATION HOLDER
atí
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Všeobecná CNS aktivita Opatrnosť potrebná u pacientov konzumujúcich alkohol alebo už
8.
je
EU/ 1/ 07/ 415/ 022-026
ívajúcich lieky, ktoré môž u
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
spôsobiťdepresiu centrálneho nervového systému.
27 September 2007.
Súbež už né ívanie olanzapínu s antiparkinsonikami u pacientov s Parkinsonovou chorobou a demenciou sa neodporúč (pozri č 4. 4).
70 10.
asť
DATE OF REVISION OF THE TEXT
QTc interval
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
66 Opatrnosť potrebná, ak sa olanzapín podáva súbež s liekmi, ktoré predlž QTc interval (pozri č 4. 4). asť
71 1.
je
Zalasta 20 mg tablets
ne
2.
ujú
Each tablet contains 20 mg olanzapine.
4. 6 Gravidita a laktácia
Excipient:
Gravidita:
For a full list of excipients, see section 6.1.
Pre gravidné ž nie sú ž iadne primerané a dobre kontrolované š
3.
eny
Tablet.
túdie.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 20”.
byť pouč o nutnosti informovať
4.
ené
CLINICAL PARTICULARS
svojho lekára, ak poč lieč as
4.1 Therapeutic indications
olanzapínom otehotnejú alebo by
Adults Olanzapine is indicated for the treatment of schizophrenia.
Avš vzhľ
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
ak,
Olanzapine is indicated for the treatment of moderate to severe manic episode.
loveka sa má olanzapín podávať
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
poč gravidity len vtedy, ak jeho potenciálny prínos pre matku prevýšmož riziko pre plod.
4.2 Posology and method of administration
Veľ zriedkavo boli spontánne hlásené než
Adults Schizophrenia:
iaduce udalosti ako tras, hypertónia, letargia a ospalosťu
The recommended starting dose for olanzapine is 10 mg/ day.
detí narodených matkám, ktoré už olanzapín v treť trimestri.
Manic episode:
ívali
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
om
Preventing recurrence in bipolar disorder:
Laktácia:
The recommended starting dose is 10 mg/ day.
V š sa u zdravých dojč túdii
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5- 20 mg/ day.
iacich
Gradual tapering of the dose should be considered when discontinuing olanzapine.
Priemerná ien oval
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).
expozícia dieť a (mg/ kg) v rovnováž stave bola odhadnutá na 1, 8% z dávky olanzapínu podanej
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).
nom
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
matke (mg/ kg).
In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
Pacientky je potrebné pouč o tom, ž poč lieč olanzapínom nesmú dojč svoje dieť a.
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
iť
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
4. 7 Ovplyvnenie schopnosti viesťvozidlá a obsluhovaťstroje
Dose escalation, when indicated, should be conservative in such patients.
š túdie o úč inkoch na schopnosť viesť vozidlá a obsluhovať
(See sections 4.5 and 5.2.)
Nakoľ ko
4.3 Contraindications
olanzapín môž spôsobiť
Hypersensitivity to the active substance or to any of the excipients.
ospalosť
Patients with known risk for narrow-angle glaucoma.
závraty, pacienti musia byť a
4.4 Special warnings and precautions for use
opatrní pri obsluhe strojov, vrátane
Patients should be closely monitored during this period.
vedenia motorových vozidiel.
1.5%, respectively).
4. 8 Než iaduce úč inky
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Dospelí iaduce reakcie (pozorované u ≥1% pacientov) spojené s už Najč astejš hlásené než
Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e. g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
v klinických š túdiách boli ospalosťnárast telesnej hmotnosti, eozinofília, zvýš hladiny prolaktínu,
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
cholesterolu, glukózy a triglyceridov (pozri č 4. 4), glukozúria, zvýš chuť jedla, závrat,
There was a 3-fold increase in CVAE in patients treated
akatízia, parkinsonizmus (pozri č 4. 4), dyskinéza, ortostatická hypotenzia, anticholinergné úč prechodné asymptomatické zvýš peč a edém.
73 with olanzapine compared to patients treated with placebo (1.3% vs.
asť ových transamináz (pozri č 4. 4), vyráž asténia, únava enie eň asť ka,
0.4%, respectively).
inky,
The efficacy of olanzapine was not established in these trials.
V nasledujúcej tabuľ sú uvedené než
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
iaduce reakcie a laboratórne vyšetrenia získané zo spontánnych
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
hlásení a z klinických štúdií.
Rare cases reported as NMS have also been received in association with olanzapine.
V rámci jednotlivých skupín frekvencií sú nežiaduce úč usporiadané inky nosti.
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).
Frekvencia je definovaná nasledovne: