natgillin/translations-raw huggingface dataset:
109 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
110 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
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.
a
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
U fajč
111 Haematologic toxicity:
104 Hematologická toxicita:
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Manitol Mikrokryš talická celulóza Krospovidón Čiastoč substituovaná hyprolóza ne Aspartám Kremič vápenatý itan Magnéziumstearát
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
Orodisoergovateľ tablety Zalasta sú dostupné v š kách po 14, 28, 35, 56 alebo 70 tabliet
6.6 Special precautions for disposal
v blistrovom balení (Al/ OPA/ Al/ PVC).
Any unused product or waste material should be disposed of in accordance with local requirements.
Š 6. 6 peciálne opatrenia na likvidáciu < a iné zaobchádzanie s liekom >
112 7.
105 7.
113 1.
1.
Zalasta 10 mg orodispersible tablets
Zalasta 7, 5 mg orosdispergovateľ tablety né
Each orodispersible tablet contains 10 mg olanzapine.
Kaž tableta obsahuje 7, 5 mg olanzapínu. dá
Each orodispersible tablet contains 1.00 mg aspartame.
Kaž tableta obsahuje 0, 75 mg aspartámu. dá
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).
106 Olanzapín je indikovaný na prevenciu rekurencie u pacientov s bipolárnou poruchou, ktorí pri manickej epizóde odpovedali na lieč olanzapínom (pozri č 5. 1).
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
ako 24 hodín.
Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapín sa môž podávať ohľ na jedlo, pretož absorpcia nie je ovplyvň
Gradual tapering of the dose should be considered when discontinuing olanzapine.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
114 Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Orodispergovateľ tabletu Zalasta je potrebné vlož do úst, kde sa rýchlo rozpustí v slinách, takž sa
Removal of the intact orodispersible tablet from the mouth is difficult.
dá ľ ahko prehltnúťOdstrániť.
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients
V placebom kontrolovaných klinických š
115 compared to patients treated with placebo (3.5% vs.
túdiách (trvanie 6- 12 týž ov) u dň
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
V placebom kontrolovaných klinických š túdiách boli pozorované než iaduce zmeny v lipidoch (pozri č 4. 8.).
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Zmeny lipidov sa majú lieč tak, ako je to klinicky vhodné, najmä u pacientov asť iť s dyslipidémiou a u pacientov s rizikovými faktormi pre vývoj porúch lipidového spektra.
116 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Zvýš opatrnosť
117 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Posturálna hypotenzia V klinických štúdiách olanzapínu sa zriedka u starš pacientov pozorovala posturálna hypotenzia.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
užívajúcich fluvoxamín, prípadne iný inhibítor CYP1A2, ako napr. ciprofloxacín, sa má zváž iť zníž poč nej dávky olanzapínu.
118 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Všeobecná CNS aktivita Opatrnosť potrebná u pacientov konzumujúcich alkohol alebo už
disorders
Zvýš telesnej
Weight gain1
Zvýš
Elevated cholesterol
hladiny ené
119
hmotnosti1
levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
ketoacidózou alebo kómou, vrátane niekoľ kých fatálnych prípadov (pozri č 4. 4)
exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
ená do jedla
Nervous system disorders
asť Hypotermia
Somnolence Cardiac disorders
Poruchy nervového systému
Dizziness Akathisia6 Parkinsonism6 Dyskinesia 6
Parkinsonizmus6 Dyskinéza 6
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
112 (pozri č 4. 4) asť Dystónia (vrátane kruhových pohybov oč ných gúľ) Tardívna dyskinéza
Vascular disorders
Symptómy z vysadenia7
Rash
ného
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions
Poruchy kostrovej a svalovej sústavy a spojivového tkaniva
120 Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
1
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
V jednej klinickej š u pacientov v manickej fáze bipolárnej poruchy bola pri lieč valproátom
121 valproate levels.
túdii
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.
Zdá sa, ž klinicky
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
Zvýš peč ových transamináz (ALT/ AST; pozri č 4. 4).
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
Nárast hmotnosti o ≥7% v porovnaní s poč nou telesnou hmotnosť (kg) sa vyskytoval veľ 9
Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/ l) to high (≥ 5.17 mmol/ l) were very common.
Zmeny hladín celkového cholesterolu nalač z normálnej poč nej hodnoty (< 4, 39 mmol/ l) na
12 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
poč nej hodnoty (≥4, 39 - < 5, 17 mmol/ l) na ≥5, 17 mmol/ l sa vyskytovali veľ č 12
4.9 Overdose
mi asto.
Signs and symptoms
4. 9 Predávkovanie
122 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.
Príznaky a symptómy Medzi veľ č príznaky predávkovania (výskyt > 10%) patrí tachykardia, agitácia/ agresivita, mi asté dyzartria, rôzne extrapyramídové príznaky a zníž stupeň
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.
neuroleptický malígny syndróm, útlm dýchania, aspirácia, hypertenzia alebo hypotenzia, sr dcová arytmia (< 2% prípadov predávkovania) a zástava dýchania a č innosti srdca.
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
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
Na rozdiel od niektorých iných antipsychotík, olanzapín zvyš uje reaktivitu v „ anxiolytickom “ teste.
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 dvoch z dvoch placebom kontrolovaných a dvoch z troch porovnávacích kontrolovaných š túdií s viac ako 2 900 schizofrenickými pacientmi s pozitívnymi i negatívnymi symptómami vykazoval olanzapín š
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
V medzinárodnej, dvojito zaslepenej, porovnávacej š zahŕajúcej 1 481 pacientov so ň túdii schizofréniou, schizoafektívnymi a príbuznými poruchami a s rôznymi stupň pridruž
123 (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
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
Olanzapín sa podával vo flexibilnej dávke od 2, 5 mg až 20 do mg denne.
In 44
ích
124 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
Reversible
kých psov,
125 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
Not applicable.
119 Neaplikovateľ né.
126 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovinsko ka
127 1.
1.
Zalasta 15 mg orodispersible tablets
Zalasta 10 mg orosdispergovateľ tablety né
Each orodispersible tablet contains 15 mg olanzapine.
Kaž tableta obsahuje 10 mg olanzapínu. dá
Each orodispersible tablet contains 1.50 mg aspartame.
Kaž tableta obsahuje 1, 00 mg aspartámu. dá
128 Olanzapine can be given without regards for meals as absorption is not affected by food.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
Removal of the intact orodispersible tablet from the mouth is difficult.
dá ľahko prehltnúťOdstrániť orodispergovateľ tabletu z úst bez poruš je ť. túto nú
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).
121 hlásené v krátkodobých š túdiách u adolescentných pacientov v porovnaní so š túdiami s dospelými pacientmi (pozri č 4. 4, 4. 8, 5. 1 a 5. 2). asti
129 duration) of elderly patients (mean age 78 years) with dementia-related 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.
starš pacientov (priemerný vek 78 rokov) s psychózou súvisiacou s demenciou a/ alebo poruchami ích správania bola u pacientov liečených olanzapínom 2- násobná incidencia úmrtia v porovnaní s š pacientami už ívajúcimi placebo (3, 5% vs.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
U vš etkých pacientov lieč ených olanzapínom alebo placebom, u ktorých sa vyskytla cerebrovaskulárna príhoda, boli už predtým prítomné rizikové faktory.
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.
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).
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.
U diabetických pacientov a pacientov s rizikovými faktormi pre vývoj ným diabetu, u ktorých sa odporúč pravidelná kontrola glukózy, je vhodné prísluš klinické monitorovanie.
8).
V placebom kontrolovaných klinických š č 4. 8.).
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Zmeny lipidov sa majú lieč tak, asť iť
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.
túdiách boli pozorované nežiaduce zmeny v lipidoch (pozri ako je to klinicky vhodné, najmä u pacientov
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
s dyslipidémiou a u pacientov s rizikovými faktormi pre vývoj porúch lipidového spektra.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Anticholinergný úč inok inok, skúsenosti z klinických š Aj keďolanzapín in vitro prejavil anticholinergný úč ž
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Keď e sú vš klinické skúsenosti s podávaním olanzapínu ak pacientom s inými súbež nými ochoreniami obmedzené, pri predpisovaní pacientom s hypertrofiou prostaty alebo paralytickým ileom a podobnými stavmi sa odporúč postupovať
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.
Č asto, najmä na zač iatku lieč bolo pozorované prechodné asymptomatické zvýš hladiny
130 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Zvýš opatrnosť
131 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Posturálna hypotenzia V klinických štúdiách olanzapínu sa zriedka u starš pacientov pozorovala posturálna hypotenzia.
4.5 Interaction with other medicinal products and other forms of interaction
124 4. 5 Liekové a iné interakcie
Interaction studies have only been performed in adults.
Interakč š né túdie sa uskutoč len u dospelých. nili
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
adom na fakt, ž olanzapín je metabolizovaný izoenzýmom CYP1A2, látky, ktoré môž Vzhľ
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
špecificky indukovať alebo inhibovať tento izoenzým, môž ovplyvniť
Only slight to moderate increase in olanzapine clearance has been observed.
farmakokinetiku olanzapínu.
132 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Monitorovanie terapeutických plazmatických hladín valproátu neukázalo, ž by pri zač prídavnej medikácie olanzapínom bola pož adovaná úprava dávkovania valproátu.
4.6 Pregnancy and lactation
4. 6 Gravidita a laktácia 125 Gravidita:
Pregnancy:
Pacientky musia
Thrombocytopenia Allergic reaction
ketoacidózou alebo kómou, vrátane
133 Metabolism and nutrition disorders Weight gain1
triglyceridov2, 5 Glukozúria Zvýš chuť ená do jedla
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
niekoľ kých fatálnych prípadov (pozri č 4. 4) asť Hypotermia
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Ospalosť
Nervous system disorders Somnolence
Závrat Akatízia6
Dizziness Akathisia6
Záchvaty, prič om š väčinou bol hlásený ich výskyt
seizures or risk factors
Bradykardia ž QT c Predĺ enie (pozri č 4. 4) asť
Cardiac disorders
Ventrikulárna tachykardia/ fibrilác ia, náhle úmrtie (pozri č 4. 4) asť
Dyskinesia
Ortostatická hypotenzia
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Tromboembólia (vrátane pľúcnej embólie a hlbokej žilovej trombózy)
Vascular disorders
Pankreatitída
Gastrointestinal disorders
alebo zmieš aného poš kodenia)
Mild, transient anticholinergic effects including constipation and dry mouth
Poruchy kostrovej a svalovej sústavy a spojivového tkaniva
Pancreatitis
ovej
Hepato-biliary disorders
Oneskorené močenie
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Celkové ochorenia a reakcie v mieste podania
134 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
prolaktínu8
135 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.
v kombinácii s olanzapínom incidencia neutropénie 4, 1%; potenciálne prispievajúcim faktorom by mohli byť vysoké plazmatické hladiny valproátu.
136 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.
Príznaky a symptómy Medzi veľ č príznaky predávkovania (výskyt > 10%) patrí tachykardia, agitácia/ agresivita, mi asté dyzartria, rôzne extrapyramídové príznaky a zníž stupeň
Management of overdose There is no specific antidote for olanzapine.
130 Pre olanzapín neexistuje ž iadne špecifické antidotum.
137 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
138 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
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).
132 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).
139 Haematologic toxicity:
Hematologická toxicita:
140 7.
itý
Date of first authorisation:
134 Dátum prvej registrácie:
141 1.
1.
Zalasta 20 mg orodispersible tablets
Zalasta 15 mg orosdispergovateľ tablety né
Each orodispersible tablet contains 20 mg olanzapine.
Kaž tableta obsahuje 15 mg olanzapínu. dá
Each orodispersible tablet contains 2.00 mg aspartame.
Kaž tableta obsahuje 1, 50 mg aspartámu. dá
Preventing recurrence in bipolar disorder:
135 Prevencia rekurencie bipolárnej poruchy:
142 Olanzapine can be given without regards for meals as absorption is not affected by food.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
Children and adolescentsOlanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Deti a mladiství Olanzapín sa neodporúč použ u detí a mladistvých vo veku do 18 rokov kvôli nedostatoč
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed
V placebom kontrolovaných klinických š
143 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.
starš pacientov (priemerný vek 78 rokov) s psychózou súvisiacou s demenciou a/ alebo poruchami ích správania bola u pacientov liečených olanzapínom 2- násobná incidencia úmrtia v porovnaní s š pacientami už ívajúcimi placebo (3, 5% vs.
144 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Zvýš opatrnosť
However, as with other antipsychotics, 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.
predlž ujúcim QTc interval, najmä u starš pacientov, u pacientov s vrodeným ích ž syndrómom predĺ
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
Č asová súvislosť by olanzapínom a venóznej tromboembólie (VTE) bola hlásená veľ zriedkavo
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Napriek tomu, keď e sú u pacientov so schizofréniou č prítomné získané rizikové