natgillin/translations-raw huggingface dataset:
Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC)
Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC)
EU/ 1/ 07/ 415/ 032 EU/ 1/ 07/ 415/ 033 EU/ 1/ 07/ 415/ 034 EU/ 1/ 07/ 415/ 035 EU/ 1/ 07/ 415/ 036 EU/ 1/ 07/ 415/ 037 EU/ 1/ 07/ 415/ 038 EU/ 1/ 07/ 415/ 039 EU/ 1/ 07/ 415/ 040 EU/ 1/ 07/ 415/ 041 EU/ 1/ 07/ 415/ 042 EU/ 1/ 07/ 415/ 043 EU/ 1/ 07/ 415/ 044 EU/ 1/ 07/ 415/ 045 EU/ 1/ 07/ 415/ 046 EU/ 1/ 07/ 415/ 047 EU/ 1/ 07/ 415/ 048 EU/ 1/ 07/ 415/ 049 EU/ 1/ 07/ 415/ 050 EU/ 1/ 07/ 415/ 051 EU/ 1/ 07/ 415/ 052 EU/ 1/ 07/ 415/ 053 EU/ 1/ 07/ 415/ 054 EU/ 1/ 07/ 415/ 055 EU/ 1/ 07/ 415/ 056
1/ 2 EU/ 1/ 07/ 415/ 032 EU/ 1/ 07/ 415/ 033 EU/ 1/ 07/ 415/ 034 EU/ 1/ 07/ 415/ 035 EU/ 1/ 07/ 415/ 036 EU/ 1/ 07/ 415/ 037 EU/ 1/ 07/ 415/ 038 EU/ 1/ 07/ 415/ 039 EU/ 1/ 07/ 415/ 040 EU/ 1/ 07/ 415/ 041 EU/ 1/ 07/ 415/ 042 EU/ 1/ 07/ 415/ 043 EU/ 1/ 07/ 415/ 044 EU/ 1/ 07/ 415/ 045 EU/ 1/ 07/ 415/ 046 EU/ 1/ 07/ 415/ 047 EU/ 1/ 07/ 415/ 048 EU/ 1/ 07/ 415/ 049 EU/ 1/ 07/ 415/ 050 EU/ 1/ 07/ 415/ 051 EU/ 1/ 07/ 415/ 052 EU/ 1/ 07/ 415/ 053 EU/ 1/ 07/ 415/ 054 EU/ 1/ 07/ 415/ 055 EU/ 1/ 07/ 415/ 056
5 mg 5 mg 5 mg 5 mg 5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg 7.5 mg 10 mg 10 mg 10 mg 10 mg 10 mg 15 mg 15 mg 15 mg 15 mg 15 mg 20 mg 20 mg 20 mg 20 mg 20 mg
5 mg 5 mg 5 mg 5 mg 5 mg 7, 5 mg 7, 5 mg 7, 5 mg 7, 5 mg 7, 5 mg 10 mg 10 mg 10 mg 10 mg 10 mg 15 mg 15 mg 15 mg 15 mg 15 mg 20 mg 20 mg 20 mg 20 mg 20 mg
Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta Orodispergovateľna tableta
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie Perorálne použitie
Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC)
Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC) Blister (Al // OPA/ Al/ PVC)
Zalasta 2.5 mg tablets
Zalasta 2, 5 mg tablety
Each tablet contains 2.5 mg olanzapine.
Kaž tableta obsahuje 2, 5 mg olanzapínu. dá
Each tablet contains 40.4 mg lactose.
Kaž tableta obsahuje 40, 4 mg laktózy. dá Úplný zoznam pomocných látok, pozri č 6. 1. asť
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.
Tablety sú okrúhle, mierne bikonvexné, slabož tablety s mož ou ojedinelých ž ltých š n.
Adults Olanzapine is indicated for the treatment of schizophrenia.
Dospelí Olanzapín je indikovaný na lieč schizofrénie. bu
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapín je úč pri udrž klinického zlepš poč pokrač
Olanzapine is indicated for the treatment of moderate to severe manic episode.
Olanzapín je indikovaný na lieč stredne ť kých až až ť kých manických epizód.
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).
Olanzapín je indikovaný na prevenciu rekurencie u pacientov s bipolárnou poruchou, ktorí pri manickej epizóde odpovedali na lieč olanzapínom (pozri č 5. 1).
The recommended starting dose for olanzapine is 10 mg/ day.
Odporúč poč ná dávka olanzapínu je 10 mg/ deň
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Poč ná dávka je 15 mg v jednej dávke denne v monoterapii alebo 10 mg denne iatoč pri kombinovanej terapii (pozri č 5. 1). asť
The recommended starting dose is 10 mg/ day.
Odporúč poč ná dávka je 10 mg/ deňU pacientov,
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Pokiaľ objaví nová manická, zmieš alebo depresívna epizóda, lieč
If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
V priebehu lieč schizofrénie, manických epizód a prevencie rekurencie bipolárnej poruchy môž
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.
byť denné dávkovanie následne prispôsobované na základe individuálneho klinického stavu v š rozmedzí 5- 20 mg/ deň Zvýš na vyšiu ako odporúč poč nú dávku sa odporúč len po
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.
Olanzapín sa môž podávať ohľ na jedlo, pretož absorpcia nie je ovplyvň
2 Olanzapine can be given without regards for meals as absorption is not affected by food.
Pri vysadzovaní olanzapínu sa má zváž postupné zniž
Gradual tapering of the dose should be considered when discontinuing olanzapine.
2 Deti a mladiství Olanzapín sa neodporúč použ u detí a mladistvých vo veku do 18 rokov kvôli nedostatoč
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.
Vyš stupeňprírastku na hmotnosti, zmien lipidov a prolaktínu boli í hlásené v krátkodobých š
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).
Starší š Podanie nižej poč nej dávky (5 mg/ deň nie je zvyč indikované, avš má sa zváž u
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).
pacientov vo veku 65 rokov a viac, ak to ich klinický stav vyžaduje (pozri tiež asť
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
V prípade mierneho poš peč (cirhóza, Child- Pugh trieda A alebo B)
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.
iatoč má byť iatoč dávka 5 mg a zvyš
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Ž enám, v porovnaní s muž nie je zvyč nutné upravovať iatoč dávku a dávkovacie rozpätie.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Nefajčiarom, v porovnaní s fajč iarmi, nie je zvyč potrebné upravovať iatoč dávku a dávkovacie rozpätie.
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
Zvyš indikované, musí byť
Dose escalation, when indicated, should be conservative in such patients.
ovanie dávky u týchto osôb, ak je
(See sections 4.5 and 5.2.)
(Pozri č 4. 5 a 5. 2) asti
Patients with known risk for narrow-angle glaucoma.
Pacienti so známym rizikom glaukómu ostrého uhla.
4.4 Special warnings and precautions for use
Poč antipsychotickej lieč môž trvať
During antipsychotic treatment, improvement in the patient's clinical condition may ta ke several days to some weeks.
niekoľ dní až dň kým dôjde k zlepš klinického ko týž ov, eniu
Patients should be closely monitored during this period.
stavu pacienta V tomto období musia byťpacienti podrobení starostlivej kontrole.
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Psychóza súvisiaca s demenciou a/ alebo poruchy správania Olanzapín nie je schválený na lieč psychózy súvisiacej s demenciou a/ alebo porúch správania a jeho bu podávanie tejto skupine pacientov sa neodporúč z dôvodu zvýš mortality a rizika
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 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.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Vyšia incidencia úmrtia nesúvisela s dávkou ž olanzapínu (priemerná denná dávka 4, 4 mg) alebo s dĺ lieč Rizikové faktory, ktoré sa môž
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.
podieľ na zvýš mortalite u tejto skupiny pacientov, sú vek nad 65 rokov, dysfágia, sedácia,
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 súčasné š už ívanie benzodiazepínov.
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
U pacientov lieč
There was a 3-fold increase in CVAE in patients treated
ených olanzapínom
3 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.
3 cerebrovaskulárna príhoda, boli užpredtým prítomné rizikové faktory.
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Vek > 75 rokov a vaskulárna/ zmieš demencia boli zistené ako rizikové faktory pre CVAE v súvislosti s lieč
The efficacy of olanzapine was not established in these trials.
túdiách nebola stanovená.
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Neodporúč sa použ olanzapínu na lieč psychózy súvisiacej s podávaním dopamínového
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
frekvenciou ako u placeba zaznamenané zhorš parkinsonovskej symptomatiky a halucinácie (pozri enie č 4. 8), prič olanzapín nebol v lieč psychotických príznakov úč asť
In these trials, patients were 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
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
vyš etrujúceho lekára bola titrovaná do maximálnej dávky 15 mg/ deň
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Neuroleptický malígny syndróm (NMS)
Rare cases reported as NMS have also been received in association with olanzapine.
Klinické ené prejavy NMS sú hyperpyrexia, svalová rigidita, zmenený duš
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).
Ď ími alš príznakmi môž byť
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
zvýš hladina kreatinínfosfokinázy, myoglobinúria (rabdomyolýza) a akútne ená
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.
Ak sa u pacienta vyvinú znaky a príznaky, ktoré naznač prítomnosť
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
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).
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
V niektorých prípadoch tomu predchádzalo zvýš telesnej hmotnosti, č mohlo byť asť
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.
U diabetických pacientov a pacientov s rizikovými faktormi pre vývoj ným diabetu, u ktorých sa odporúč pravidelná kontrola glukózy, je vhodné prísluš klinické monitorovanie.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
túdiách boli pozorované nežiaduce zmeny v lipidoch (pozri ako je to klinicky vhodné, najmä u pacientov
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
s dyslipidémiou a u pacientov s rizikovými faktormi pre vývoj porúch lipidového spektra.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Anticholinergný úč inok inok, skúsenosti z klinických š Aj keďolanzapín in vitro prejavil anticholinergný úč ž
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.
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
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Zvýš opatrnosť
Caution should be exercised in patients with elevated ALT and/ or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
potrebná u pacientov so zvýš enými hodnotami ALT a/ alebo AST, u pacientov so znakmi a príznakmi poš kodenia peč u pacientov s preexistujúcimi stavmi spojenými s obmedzenou funkč rezervou
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
V prípade vyšej hladiny ALT
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 poškodenia peč ene), musí sa lieč olanzapínom ukonč.
4 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.
4 súbež ochorením, radiač terapiou alebo chemoterapiou a u pacientov s hypereozinofíliou alebo
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Neutropénia bola č hlásená pri súbež už valproátu (pozri č 4. 8). asť
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.
Pri náhlom ukonč lieč olanzapínom boli veľ zriedkavo (< 0, 01%) hlásené akútne príznaky ako
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.
túdiách bolo u pacientov lieč ených olanzapínom klinicky významné predĺ enie intervalu (korekcia QT podľ Fridericii [QTcF] ≥ milisekúnd [msec] kedykoľ po vstupnom
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.
vek
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
etrení u pacientov so vstupnou hodnotou QTcF < 500 msec) menej č (0, 1% až vyš
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Tak ako u ostatných antipsychotík, je vš potrebná opatrnosťak sa olanzapín predpisuje s liekom
However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e. g. immobilisation of patients, should be identified and preventive measures undertaken.
predlž ujúcim QTc interval, najmä u starš pacientov, u pacientov s vrodeným ích ž syndrómom predĺ
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.
eného QT, s kongestívnou srdcovou nedostatoč ou, hypertrofiou srdca, nosť
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Napriek tomu, keď e sú u pacientov so schizofréniou č prítomné získané rizikové
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.
faktory venóznej tromboembólie, je nutné brať úvahy vš mož rizikové faktory VTE, napr. imobilizácia pacientov, a vykonaťpreventívne
Seizures have been reported to occur rarely in patients when treated with olanzapine.
Vzhľ adom na primárny úč olanzapínu na CNS je potrebná opatrnosť súbež už
In most of these cases, a history of seizures or risk factors for seizures was reported.
Pretož pôsobí in vitro ako dopamínový
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
antagonista, môž olanzapín antagonizovať inky priamych a nepriamych agonistov dopamínu.