natgillin/translations-raw huggingface dataset:
In cases where dose increments of 2.5 mg are considered necessary, Zalasta tablets should be used.
Zvyš indikované, musí byť
In placebo-controlled clinical trials (6-12 weeks
túdiách (trvanie 6- 12 týž ov) u dň
87 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.
There was a 3-fold increase in CVAE in patients treated 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.
78 U vš etkých pacientov lieč ených olanzapínom alebo placebom, u ktorých sa vyskytla cerebrovaskulárna príhoda, boli už predtým prítomné rizikové faktory.
In these trials, patients wer e initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
Poč ná dávka olanzapínu bola 2, 5 mg/ deň podľ uváž
Additi onal signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
zvýš hladina kreatinínfosfokinázy, myoglobinúria (rabdomyolýza) a akútne ená
88 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Zvýš opatrnosť
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
anamnézou liekmi navodeného útlmu/ toxicity kostnej drene alebo útlmom kostnej drene spôsobeným súbež ochorením, radiač terapiou alebo chemoterapiou a u pacientov s hypereozinofíliou alebo
89 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.
Aspartame Zalasta orodispersible tablets contain aspartame, a source of phenylalanine.
Pacienti so zriedkavými dedič nými problémami galaktózovej intolerancie, Lappovej deficiencie laktázy alebo malabsorpcie glukózo- galaktózy nemajú už tento ívať liek.
May be harmful for people with phenylketonuria.
Interakč š né túdie sa uskutoč len u dospelých. nili
90 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.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
81 Opatrnosť potrebná, ak sa olanzapín podáva súbež s liekmi, ktoré predlž QTc interval (pozri č 4. 4). asť
Spontaneous reports have been ver y rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
detí narodených matkám, ktoré už olanzapín v treť trimestri.
Adults 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 appet ite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
akatízia, parkinsonizmus (pozri č 4. 4), dyskinéza, ortostatická hypotenzia, anticholinergné úč prechodné asymptomatické zvýš peč a edém.
Thrombocytopenia Allergic reaction
cholesterolu 2, 3 Zvýš hladiny ené
91 Metabolism and nutrition disorders Weight gain1
glukózy 4 Zvýš hladiny ené triglyceridov2, 5
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Hypotermia
Nervous system disorders Somnolence
Poruchy nervového systému
6
Parkinsonizmus6 Dyskinéza 6
Seizures where in most cases a history of
Ochorenia srdca a poruchy srdcovej č innosti
Parkinsonism 6
Cievne poruchy
seizures or risk factors
Ortostatická hypotenzia
Cardiac disorders
Pankreatitída
Dyskinesia
ústach
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
83
Vascular disorders
Ochorenia peč a ž ových ciest ene lč
Bradycardia QT c prolongation (see section 4.4)
Prechodné, asymptomatické zvýš enie peč ových
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Hepatitída (vrátane hepatocelulárneho, cholestatického
Orthostatic hypotension
Poruchy kož a podkož
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
eň transamináz (ALT, AST), hlavne na zač iatku lieč by (pozri č 4. 4) asť
Gastrointestinal disorders
Fotosenzitívna reakcia
Mild, transient anticholinergic effects including constipation and dry mouth
Alopécia Poruchy kostrovej a svalovej sústavy a spojivového tkaniva
Pancreatitis
Rabdomyolýza
Hepato-biliary disorders
Poruchy oblič a moč sústavy
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Ochorenia reprodukč ného systému a prsníkov
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Priapizmus Celkové ochorenia a reakcie v mieste podania
Skin and subcutaneous tissue disorders
Abnormálne laboratórne a funkč vyš né etrenia
Photosensitivity reaction Alopecia
Vysoká kreatinín
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders
alkalická ená
92 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
prolaktínu8
High creatine phosphokinase Increased total bilirubin
fosfokináza Zvýš celkový ený bilirubín
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Klinicky signifikantný nárast telesnej hmotnosti sa pozoroval vo vš etkých kategóriách východiskovej hodnoty indexu telesnej hmotnosti (Body Mass Index - BMI).
Weight gain ≥ 7% of baseline body weight was very common and ≥
Nárast telesnej hmotnosti ≥7% pôvodnej telesnej hmotnosti bol veľ č a ≥15% pôvodnej telesnej hmotnosti bol č
15% of baseline body
mi astý
93 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.
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Hoci sa neuskutoč
Elevated cholesterol levels11 Nervous system disorders Very common:
Zvýš hladina cholesterolu11 ená Poruchy nervového systému Veľ č
94 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.
86 Pre olanzapín neexistuje ž iadne špecifické antidotum.
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.
Navyš v zobrazovacej š
95 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
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.
V š kombinovanej terapie u
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.
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.
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recur rence into mania or recurrence into depression.
výhodu buďz hľ adiska prevencie rekurencie mánie alebo prevencie rekurencie depresie.
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).
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 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.
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
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.
ktorí boli stabilizovaní pri lieč olanzapínom spolu so stabilizátorom nálady (lítium alebo valproát), be nebola dlhodobá kombinovaná terapia olanzapínom spolu s lítiom alebo valproátom š ž
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
významne superiorná vočlieč samotným lítiom alebo valproátom v predĺ doby do rekurencie
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
bipolárnej poruchy definovanej podľ syndrómových (diagnostických) kritérií. a
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.
Pediatrická populácia Skúsenosti s mladistvými (vo veku 13 až rokov) sú obmedzené na údaje o krátkodobej úč prípade schizofrénie (6 týž ov) a mánie
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
17 v súvislosti s bipolárnou poruchou I (3 týž
5.2 Pharmacokinetic properties
zahŕali menej ako 200 mladistvých.
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Nie sú k dispozícii údaje š
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
nosti sú obmedzené (pozri č 4. 4 a 4. 8).
96 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 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 a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
88
97 Haematologic toxicity:
Hematologická toxicita:
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.
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Monohydrát laktózy Prášková celulóza elatinovaný kukurič š Predž ný krob Kukurič š ný krob Koloidný oxid kremič bezvodý itý Magnéziumstearát
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
14, 28, 35, 56 alebo 70 tabliet v š katuľ ke.
6.6 Special precautions for disposal
Nie vš veľ etky kosti balenia musia byťuvedené do obehu.
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
98 7.
itý
MARKETING AUTHORISATION HOLDER
zlikvidovaný v súlade s miestnymi
99 1.
91 1.
Zalasta 7.5 mg orodispersible tablets
Zalasta 5 mg orosdispergovateľ tablety né
Each orodispersible tablet contains 7.5 mg olanzapine.
Kaž tableta obsahuje 5 mg olanzapínu. dá
Each orodispersible tablet contains 0.75 mg aspartame.
Kaž tableta obsahuje 0, 50 mg aspartámu. dá
Orodispersible tablet.
Orodispergovateľ tableta. ná
Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Tablety sú ž okrúhle, mierne bikonvexné, mramorovité s mož ou ojedinelých š n.
100 Olanzapine can be given without regards for meals as absorption is not affected by food.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
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 ľahko prehltnúťOdstrániť.
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Tiež mož ju
Alternatively, it may be dispersed in a full glass of water immediately before administration.
bezprostredne pred už rozpustiť pohári plnom vody.
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Orodispergovateľ tableta olanzapínu je bioekvivalentná tablete olanzapínu, s podobnou rýchlosť a
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
Orodispergovateľ tablety olanzapínu je mož už ako náhradu tabliet olanzapínu.
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.
Deti a mladiství Olanzapín sa neodporúč použ u detí a mladistvých vo veku do 18 rokov kvôli nedostatoč
In cases where dose increments of 2.5 mg are considered necessary, Zalasta tablets should be used.
V prípadoch, kedy je nevyhnutné zvyš ovaťdávky o 2, 5 mg, majú sa použ tablety Zalasta. iť
During antipsychotic treatment, improvement in the patient's clinical condition may take severa l days to some weeks.
niekoľ dní až dň kým dôjde k zlepš klinického ko týž ov, eniu
In placebo-controlled clinical trials (6-12 weeks
enej
101 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.
V placebom kontrolovaných klinických š túdiách (trvanie 6- 12 týž ov) u dň 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
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
malnutrícia a dehydratácia, pľúcne ochorenia (napr. pneumónia s alebo bez aspirácie) alebo súč asné š už ívanie benzodiazepínov.
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
túdiách boli hlásené cerebrovaskulárne nežiaduce príhody (CVAE napr.
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
bol v porovnaní s pacientami už ívajúcimi placebo 3- násobný nárast CVAE (1, 3% 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
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Vek > 75 rokov
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 relat ed conditions.
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
102 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Zvýš opatrnosť
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
diagnostikuje hepatitída (vrátane hepatocelulérnej, cholestatickej alebo neurč itého poš kodenia peč ene), musí sa lieč olanzapínom ukonč.
103 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
95 V klinických štúdiách olanzapínu sa zriedka u starš pacientov pozorovala posturálna hypotenzia.
Aspartame Zalasta orodispersible tablets contain aspartame, a source of phenylalanine.
Môž byť
May be harmful for people with phenylketonuria.
škodlivé pre ľ s fenylketonúriou. udí
104 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
96 Monitorovanie terapeutických plazmatických hladín valproátu neukázalo, ž by pri zač prídavnej medikácie olanzapínom bola pož adovaná úprava dávkovania valproátu.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Opatrnosť potrebná, ak sa olanzapín podáva súbež s liekmi, ktoré predlž QTc interval (pozri č 4. 4). asť
Leukopenia Neutropenia
Trombocytopénia
Thrombocytopenia Allergic reaction
97 Neutropénia Poruchy imunitného systému
105 Metabolism and nutrition disorders Weight gain1
Alergická reakcia Poruchy metabolizmu a výž ivy
Elevated cholesterol 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)
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
asť Hypotermia
6
Parkinsonizmus6 6
Seizures where in most cases a history of
v anamnéze alebo
Parkinsonism 6
Dyskinéza
seizures or risk factors
rizikové faktory pre ich vznik Neuroleptický malígny syndróm (pozri č 4. 4) asť
Cardiac disorders
Dystónia (vrátane kruhových pohybov oč ných gúľ) Tardívna dyskinéza Symptómy z vysadenia7
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Ochorenia srdca a poruchy srdcovej č innosti
Mild, transient anticholinergic effects including constipation and dry mouth
Mierne, prechodné anticholinergné úč vrátane inky zápchy a sucha v ústach
Hepato-biliary disorders
Ochorenia peč a ž ových ene lč
Rash
e ného
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders
Poruchy kostrovej a svalovej sústavy a spojivového tkaniva
106 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
Ochorenia reprodukč ného systému a prsníkov
High creatine phosphokinase Increased total bilirubin
Abnormálne laboratórne a funkč vyš né etrenia
Increased alkaine phosphatase
fosfokináza Zvýš celkový ený
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
1 Klinicky signifikantný nárast telesnej hmotnosti sa pozoroval vo vš etkých kategóriách východiskovej hodnoty indexu telesnej hmotnosti (Body Mass Index - BMI).
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
Akútne symptómy, ako sú potenie, nespavosťtremor, úzkosťnauzea a vracanie, boli hlásené po náhlom skonč lieč ení 8
107 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
108 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 101 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.
Lieč predávkovania ba Pre olanzapín neexistuje ž iadne špecifické antidotum.
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.
102 V medzinárodnej, dvojito zaslepenej, porovnávacej š zahŕajúcej 1 481 pacientov so ň túdii schizofréniou, schizoafektívnymi a príbuznými poruchami a s rôznymi stupň pridruž