natgillin/translations-raw huggingface dataset:
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Veľ č (10%), č v poradí klesajúcej závaž
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.
asté
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
(≥1% a < 10%), menej č (≥0, 1% and < 1%), zriedkavé (≥0, 01% a < 0, 1%), veľ zriedkavé (< 0, 01%), neznáme (nemož
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
asté odhadnúť dostupných údajov). no z
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Veľ č
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Č
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Menej č
74 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.
mi
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when olanzapine is stopped abruptly.
asté
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
asté
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
asté
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Neznáme
Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Ochorenia krvi a lymfatického systému
Seizures have been reported to occur rarely in patients when treated with olanzapine.
Poruchy imunitného systému
In most of these cases, a history of seizures or risk factors for seizures was reported.
Poruchy metabolizmu a výž ivy
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
cholesterolu 2, 3 Zvýš hladiny ené
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
exacerbácia diabetu prílež itostne
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
glukózy 4 Zvýš hladiny ené triglyceridov2, 5
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
spojená s ketoacidózou alebo kómou, vrátane niekoľ kých
75 Lactose Zalasta tablets contain lactose.
Glukozúria Zvýš chuť ená do
4.5 Interaction with other medicinal products and other forms of interaction
fatálnych prípadov (pozri č 4. 4) asť
Interaction studies have only been performed in adults.
Poruchy nervového systému
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.
Závrat Akatízia6
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Záchvaty, prič om š väčinou bol hlásený ich výskyt
Only slight to moderate increase in olanzapine clearance has been observed.
v anamnéze alebo rizikové faktory pre ich vznik
The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
Neuroleptický malígny syndróm (pozri č 4. 4) asť Dystónia (vrátane kruhových pohybov oč ných gúľ) Tardívna dyskinéza Symptómy z vysadenia7
Inhibition of CYP1A2 Fluvoxamine, a specific CYP 1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Ochorenia srdca a poruchy srdcovej č innosti
The mean increase in olanzapine AUC was 52% and 108% respectively.
Bradykardia ž QT c Predĺ enie (pozri č 4. 4) asť
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Ventrikulárna tachykardia/ fibrilác ia, náhle úmrtie (pozri č 4. 4) asť
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
Cievne poruchy
Decreased bioavailability Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
Ortostatická hypotenzia
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Tromboembólia (vrátane pľúcnej embólie a hlbokej žilovej trombózy)
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Poruchy a ochorenia gastrointestinálneho traktu
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Mierne, prechodné anticholinergné úč vrátane inky zápchy a sucha v
1A2, 2D6, 2C9, 2C19, 3A4).
Pankreatitída
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
68
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Ochorenia peč a ž ových ciest ene lč
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Prechodné, asymptomatické zvýš enie peč ových
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Hepatitída (vrátane hepatocelulárneho, cholestatického
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Poruchy kož a podkož
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
eň transamináz (ALT, AST), hlavne na zač iatku lieč by (pozri č 4. 4) asť
76 4.6 Pregnancy and lactation
alebo zmieš aného poš kodenia)
Pregnancy:
ného tkaniva
There are no adequate and well-controlled studies in pregnant women.
Fotosenzitívna reakcia
Spontaneous reports have been very rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
Alopécia Poruchy kostrovej a svalovej sústavy a spojivového tkaniva
Lactation:
Rabdomyolýza
In a study in lactating, healthy women, olanzapine was excreted in breast milk.
Poruchy oblič a moč sústavy
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Ochorenia reprodukč ného systému a prsníkov
Patients should be advised not to breast feed an infant if they are taking olanzapine.
Priapizmus Celkové ochorenia a reakcie v mieste podania
4.7 Effects on ability to drive and use machines
Asténia Únava Edém
No studies on the effects on the ability to drive and use machines have been performed.
Abnormálne laboratórne a funkč vyš né etrenia
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Zvýš hladiny
4.8 Undesirable effects
Vysoká kreatinín
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 appetite, 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.
prolaktínu8
The frequency terms listed are defined as follows:
fosfokináza Zvýš celkový ený bilirubín
Very common (≥
fosfatáza
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
1
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Nárast telesnej hmotnosti ≥7% pôvodnej telesnej hmotnosti bol veľ č a ≥15% pôvodnej telesnej hmotnosti bol č
Very common
mi astý
Common
astý.
Uncommon
enia
Not known
no
Blood and the lymphatic system disorders Immune system disorders
boli vyšie u pacientov bez predtým dokázanej lipidovej dysregulácie.
Eosinophilia
69 3 Pozorované pri normálnych hladinách nalač na zač
Leukopenia Neutropenia
iatku (< 5, 17 mmol/ l), ktoré sa zvýš na ili
Thrombocytopenia Allergic reaction
hladinu vysokú (≥6, 2 mmol/ l).
Metabolism and nutrition
5, 17 - < 6, 2 mmol/ l) na hodnotu vysokú (≥ mmol/ l) boli
disorders
no veľ č
Weight gain1
nej
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
hodnoty (≥ 4
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Pozorované pri normálnych východiskových hladinách nalač (< 5, 56 mmol/ l), ktoré sa zvýš na
Nervous system disorders Somnolence
hladinu vysokú (≥7 mmol/ l).
Dizziness Akathisia6
iatku (< 1, 69 mmol/ l), ktoré sa zvýš na ili
Seizures where in most cases a history of
hladinu vysokú (≥2, 26 mmol/ l).
77
no
Cardiac disorders
nej
Parkinsonism6 Dyskinesia 6
6 V klinických štúdiách bol výskyt parkinsonizmu a dystónie u pacientov lieč ených olanzapínom poč vyší, ale š š
seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
U pacientov už il
Vascular disorders
ívajúcich olanzapín
Bradycardia QT c prolongation (see section 4.4)
koch v osobnej anamnéze, nie je mož v súčné k
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Akútne symptómy, ako sú potenie, nespavosťtremor, úzkosťnauzea a vracanie, boli hlásené po náhlom skonč lieč ení
Orthostatic hypotension
olanzapínom. by
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Dlhodobá expozícia (aspoň týž ov) 48 dň Pomer pacientov, u ktorých sa vyskytli než
Gastrointestinal disorders
priemernej hladiny krvnej glukózy spomalila približ po 4- 6 mesiacoch. ne
Mild, transient anticholinergic effects including constipation and dry mouth
s placebom vyš incidencia úmrtí a cerebrovaskulárnych než Veľ
Pancreatitis
č než mi asté
Hepato-biliary disorders
ia iaduce reakcie pri už
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
iaducich reakcií (pozri tiež asť
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Č boli pozorované pneumónia, zvýš telesná teplota, letargia, erytém, zrakové
Skin and subcutaneous tissue disorders
asto
Rash
ená
Photosensitivity reaction Alopecia
halucinácie a inkontinencia moč u.
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
V klinických štúdiách u pacientov s liekmi vyvolanou psychózou (dopamínovým agonistom) súvisiacou s Parkinsonovou chorobou, boli veľ č a s vyšou frekvenciou ako u placeba š mi asto zaznamenané zhorš parkinsonovskej symptomatiky a halucinácie. enie
High creatine phosphokinase Increased total bilirubin
V jednej klinickej š u pacientov v manickej fáze bipolárnej poruchy bola pri lieč valproátom
Increased alkaine phosphatase
a k nárastu telesnej hmotnosti.
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
v kombinácii s lítiom alebo divalproexom doš v akútnej fáze lieč (do 6 týž ov) k nárastu telesnej
Weight gain ≥ 7% of baseline body weight was very common and ≥
7%
15% of baseline body
iatoč
78
ba
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
olanzapínom (do 12 mesiacov) na prevenciu rekurencie u pacientov s bipolárnou poruchou bola ením telesnej hmotnosti o  v porovnaní s poč nou hodnotou u 39, 9% spojená so zvýš pacientov.
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
7%
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
Hoci sa neuskutoč
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
žiadne klinické štúdie porovnávajúce mladistvých pacientov s dospelými, údaje získané zo š túdií s mladistvými pacientmi boli porovnané s údajmi získanými zo š s dospelými pacientami. túdií
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
š V nasledujúcej tabuľ sú uvedené než
In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it can not be concluded at present that olanzapine produces less tardive dyskinesia and/ or other tardive extrapyramidal syndromes.
ke
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
iaduce reakcie hlásené s vyšou frekvenciou u mladistvých
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
pacientov (vo veku 13 – 17 rokov) ako u dospelých pacientov alebo než
In most patients, levels returned to normal ranges without cessation of treatment.
iaduce reakcie, ktoré boli
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
Zdá sa, ž klinicky
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
významný prírastok na hmotnosti (≥7%) sa vyskytuje č
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
dospelými pri porovnateľ ných expozíciách.
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Výš hmotnostného prírastku a pomer adolescentných ka š pacientov, u ktorých bol klinicky signifikantný hmotnostný prírastok, bol vyš pri dlhodobej expozícii í (aspoň týž ov) ako pri krátkodobej expozícii.
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.
dň
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 rámci jednotlivých skupín frekvencií sú nežiaduce úč usporiadané v poradí klesajúcej inky nosti.
Olanzapine administered with lithium or valproate resulted in increased levels ( 10%) of tremor, dry mouth, increased appetite, and weight gain.
Veľ č (10%), č (≥1% a < 10%). závaž
Speech disorder was also reported commonly.
Poruchy metabolizmu a výž Veľ č
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).
Hmotnostný prírastok9, zvýš hladina triglyceridov10, zvýš chuť jedla.
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.
Zvýš hladina cholesterolu11 ená Poruchy nervového systému Veľ č
79 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Gastrointestinálne poruchy Č asté:
Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials.
Vyš etrenia Veľ č
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.
Zníž celkového bilirubínu, zvýš GMT, zvýš plazmatickej hladiny prolaktínu12.
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Pri dlhodobej expozícii (aspoň
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.
24 týž ov), približ polovica adolescentných pacientov dosiahla ≥15% a takmer tretina dosiahla
Very common (≥ 10%), common (≥ 1% and < 10%).
≥25% nárastu ich pôvodnej telesnej hmotnosti.
Weight gain9, elevated triglyceride levels10, increased appetite.
≥1, 467 mmol/ l a zmeny triglyceridov nalač z hranič poč nej hodnoty (≥1, 016 mmol/ l - < 1, 467 mmol/ l) na ≥1, 467 mmol/ l.
Sedation (including: hypersomnia, lethargy, somnolence).
Zmeny hladín celkového cholesterolu nalač z normálnej poč nej hodnoty (< 4, 39 mmol/ l) na
Dry mouth Hepato-biliary disorders Very common:
≥5, 17 mmol/ l sa vyskytovali č Zmeny hladín celkového cholesterolu nalač z hranič
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
poč nej hodnoty (≥4, 39 - < 5, 17 mmol/ l) na ≥5, 17 mmol/ l sa vyskytovali veľ č 12
Investigations Very common:
mi asto.
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
Zvýš plazmatickej hladiny prolaktínu bolo hlásené u 47, 4% mladistvých pacientov. enie
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
4. 9 Predávkovanie
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
Príznaky a symptómy Medzi veľ č príznaky predávkovania (výskyt > 10%) patrí tachykardia, agitácia/ agresivita, mi asté dyzartria, rôzne extrapyramídové príznaky a zníž stupeň
11 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/ l) to high (≥ 5.17 mmol/ l) were observed commonly.
vedomia od útlmu až kómu. po
12 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
K ď ím zdravotne významným dôsledkom predávkovania patria delírium, kŕe, kóma, mož č
4.9 Overdose
alš
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.
ný
80 Management of overdose There is no specific antidote for olanzapine.
71 Pre olanzapín neexistuje ž iadne špecifické antidotum.
81 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.
82 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.
73
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 nižiu priemernú telesnú hmotnosť š a menšpoč fajč
Such factors possibly contribute to the higher average exposure observed in adolescents.
Tieto faktory mož prispeli k vyšej priemernej expozícii no
83 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 cica vcoch.
EU/ 1/ 07/ 415/ 027-031
EU/ 1/ 07/ 415/ 022- 026
Zalasta 5 mg orodispersible tablets
Zalasta 20 mg tablety
Each orodispersible tablet contains 5 mg olanzapine.
Kaž tableta obsahuje 20 mg olanzapínu. dá
Each orodispersible tablet contains 0.50 mg aspartame.
Kaž tableta obsahuje 323, 5 mg laktózy. dá Úplný zoznam pomocných látok, pozri č 6. 1. asť
Orodispersible tablet.
Tableta.
Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Tablety sú okrúhle, mierne bikonvexné, slabož tablety s mož ou ojedinelých ž ltých š n a s nápisom “ 20 ”.
86 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.
Olanzapín sa neodporúč použ u detí a mladistvých vo veku do 18 rokov kvôli nedostatoč
Removal of the intact orodispersible tablet from the mouth is difficult.
údajom o bezpeč nosti a úč innosti.
Alternatively, it may be dispersed in a full glass of water immediately before administration.
Vyš stupeňprírastku na hmotnosti, zmien lipidov a prolaktínu boli í hlásené v krátkodobých š
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
túdiách u adolescentných pacientov v porovnaní so
It has the same dosage and frequency of administration as olanzapine tablets.
š túdiami s dospelými
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
pacientmi (pozri č 4. 4, 4. 8, 5. 1 a 5. 2). asti
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consider ation should be given to decreasing the starting dose.
Pri prítomnosti viac ako jedného faktora, ktorý môž spomaľ
Dose escalation, when indicated, should be conservative in such patients.
ovaťmetabolizmus (ž enské pohlavie,