qanastek/EMEA-V3 huggingface dataset:
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Bendrasis CNS aktyvumas Reikia atsargiai gydyti pacientus, kurie geria alkoholio arba vartoja vaistini preparat, galin i slopinticentrin nerv sistem.
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).
4. 4 skyri).
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
4. 4 skyri).
There are no adequate and well-controlled studies in pregnant women.
N ra adekva i ir gerai kontroliuojam olanzapino poveikio n š iajai tyrim.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Š vaist vartojan i moter reikia sp ti, kad ji pranešt savo gydytojui, jei pastojo ar ketina pastoti.
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Dar n ra pakankamai duomen apie šio vaisto poveik žmogaus vaisiui, tod l n š iosioms jo galima skirti tik tuomet, kai laukiamas nauda pateisins galim rizik vaisiui.
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.
Buvo gauti labai reti pavieniai pranešimai, kad k dikiams, kuriuos pagimd paskutinius tris n štumo m nesius olanzapin vartojusios moterys, atsirado tremoras, hipertonija, letargija ir mieguistumas.
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Klinikiniuose tyrimuose su sveikomis k dik žindan iomis moterimis buvo nustatyta, kad olanzapino patenka motinos pien.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Kai vaisto koncentracija plazmoje pastovi, vidutin k dikio ekspozicija (mg/ kg) yra 1, 8% motinos olanzapino doz s (mg/ kg).
Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Pacient ms reikia patarti, kad, vartodamos olanzapin, k dikio nežindyt.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Olanzapinas gali sukelti mieguistum ir galvos svaigim, tod l j vartojantys asmenys turi b ti atsarg s valdydami mechanizmus ir vairuodami.
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,
4. 4 skyri), gliukozurija, apetito padid jimas, galvos svaigimas, akatizija, parkinsonizmas (žr.
7 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
4. 4 skyri), diskinezija, ortostatin hipotenzija, anticholinerginis poveikis, trumpalaikis simptom nesukeliantis kepen transaminazi aktyvumo padid jimas (žr.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Toliau esan ioje lentel je išvardytos nepageidaujamos reakcijos ir laboratorini tyrim duomenys, gauti iš pavieni pranešim ir klinikini tyrim.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Kiekvienoje dažnio grup je nepageidaujamos
The frequency terms listed are defined as follows:
7 reakcijos pateikiamos maž jan io sunkumo tvarka.
Very common (10%), common (1% and < 10%), uncommon (0.1% and < 1%), rare (0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Išvardytas sutrikim dažnis apib dinamas taip: labai dažni (10%), dažni (nuo 1% iki < 10%), nedažni (nuo 0, 1% iki < 1%), reti (nuo 0, 01% iki < 0, 1%), labai reti (< 0, 01%), dažnis nežinomas (negali b ti vertintas pagal turimus duomenis).
Blood and the lymphatic system disorders
Kraujo ir limfin s sistemos sutrikimai
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Imunin s sistemos sutrikimai Alergin reakcija Metabolizmo ir mitybos sutrikimai Svorio padid jimas 1
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
Cholesterolio koncentracijos padid jimas 2, 3 Gliukoz s koncentracijos padid jimas 4 Triglicerid koncentracijos padid jimas 2, 5 Gliukozurija Apetito padid jimas
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
4. 4 skyri) Hipotermija
Nervous system disorders Somnolence Cardiac disorders
Nerv sistemos sutrikimai Somnolencija Širdies sutrikimai
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
4. 4 skyri) Distonija (skaitant okulogiracij) V lyvoji diskinezija Nutraukimo simptomai 7
Vascular disorders
Bradikardija QTc pailg jimas (žr.
Bradycardia QTc prolongation (see section 4.4)
4. 4 skyri)
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Kraujagysli sutrikimai
Orthostatic hypotension
Ortostatin hipotenzija
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Tromboembolija (skaitant plau i embolij ir gili j ven tromboz)
Mild, transient anticholinergic effects including constipation and dry mouth
Lengvas, trumpalaikis anticholinerginis poveikis, skaitant viduri užkiet jim ir burnos dži vim
8 Hepato-biliary disorders
8 Kepen, tulžies p sl s ir latak sutrikimai
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
4. 4 skyri)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Hepatitas (skaitant kepen l steli, cholestazin ar mišr kepen pažeidim)
Rash
sutrikimai Išb rimas
Photosensitivity reaction Alopecia
Padid jusio jautrumo šviesai reakcija Alopecija
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 levels8 1
Metabolizmo ir mitybos sutrikimai Rabdomioliz Inkst ir šlapimo tak sutrikimai Sunkumas prad ti šlapintis Lytin s sistemos ir kr ties sutrikimai Priapizmas Bendrieji sutrikimai ir vartojimo vietos pažeidimai Astenija Nuovargis Edema Tyrimai Prolaktino koncentracijos plazmoje padid jimas 8 1
High creatine phosphokinase Increased total bilirubin
Kreatino fosfokinaz s suaktyv jimas Bendrojo bilirubino koncentracijos padid jimas
Increased alkaine phosphatase
Šarmin s fosfataz s suaktyv jimas
Weight gain 7% of baseline body weight was very common and 15% of baseline body weight was common.
Nepriklausomai nuo bazinio k no mas s indekso klinikai reikšmingai k no svoris padid jo visiems tiriamiesiems. ≥ 7% k no svorio padid jimas buvo labai dažnas, ≥ 15% − dažnas.
Patients gaining 25% of their baseline body weight with long-term exposure were very common.
Ilgalaik s ekspozicijos metu ≥ 25% pacient k no svorio padid jimas buvo labai dažnas.
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
2 Pacientams, kuriems prieš pradedant gydyti lipid apykaitos sutrikim nebuvo, vidutinis j (bendro cholesterolio, MTL cholesterolio ir triglicerid) kiekio padid jimas nevalgius buvo didesnis.
3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (6.2 mmol/ l).
3 Normali pradin koncentracija nevalgius (< 5, 17 mmol/ l), kuri padid jo iki didel s (≥ 6, 2 mmol/ l).
Changes in total fasting cholesterol levels from borderline at baseline (5.17- < 6.2 mmol/ l) to high (6.2 mmol/ l) were very common.
Ribin s pradin s cholesterolio koncentracijos nevalgius (≥ 5, 17- 6, 2 mmol/ l) padid jimas iki didel s (≥ 6, 2 mmol/ l) buvo labai dažnas.
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (7 mmol/ l).
4 Normali pradin koncentracija nevalgius (< 5, 56 mmol/ l), kuri padid jo iki didel s (7 mmol/ l).
Changes in fasting glucose from borderline at baseline (5.56 - < 7 mmol/ l) to high (7 mmol/ l) were very common.
Ribin s pradin s gliukoz s koncentracijos nevalgius (5, 56- 7 mmol/ l) padid jimas iki didel s (7 mmol/ l) buvo labai dažnas.
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (2.26 mmol/ l).
5 Normali pradin koncentracija nevalgius (< 1, 69 mmol/ l), kuri padid jo iki didel s (≥ 2, 26 mmol/ l).
Changes in fasting triglycerides from borderline at baseline (1.69 mmol/ l - < 2.26 mmol/ l) to high (2.26 mmol/ l) were very common.
Ribin s pradin s triglicerid koncentracijos nevalgius (≥ 1, 69 - < 2, 26 mmol/ l) padid jimas iki didel s (≥ 2, 26 mmol/ l) buvo labai dažnas.
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
6 Klinikini tyrim metu parkinsonizmo ir distonijos dažnis olanzapinu gydytiems pacientams buvo didesnis, ta iau statistiškai reikšmingai nesiskyr nuo vartojusi j placeb.
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Olanzapin vartojusiems pacientams re iau negu vartojusiems titruot haloperidolio doz pasireišk parkinsonizmas, akatizija ir distonija.
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.
Be detalios informacijos apie jau buvusius minius ar v lyvuosius ekstrapiramidinius
9 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
9 jud jimo sutrikimus, negalima teigti, kad olanzapinas re iau sukelia v lyv j diskinezij ir (ar) kitus v lyvuosius ekstrapiramidinius sindromus.
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
8 Susij klinikiniai simptomai (pvz., ginekomastija, galaktor ja, kr t padid jimas) buvo reti.
In most patients, levels returned to normal ranges without cessation of treatment.
Nutraukus gydym, daugeliui pacient šie simptomai išnyko.
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Ilgalaik (mažiausiai 48 savai i) ekspozicija Pacient, kuriems atsirado nepageidaujamas kliniškai reikšmingas k no svorio padid jimas arba gliukoz s, bendro/ MTL/ DTL cholesterolio ar triglicerid kiekio pokytis, dalis laikui b gant did jo.
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
Suaugusiems pacientams, baigusiems 9 – 12 m nesi gydym, vidutinis gliukoz s kiekis kraujyje padid jino greitis maždaug po 4 – 6 gydymo m nesi sul t davo.
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 section 4.4).
4. 4 skyri).
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Labai dažnos nepageidaujamos reakcijos, susijusios su olanzapino vartojimu, šios grup s pacientams buvo eisenos sutrikimai ir pargriuvimai.
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Dažnai pasireišk pneumonija, k no temperat ros padid jimas, letargija, eritema, regos haliucinacijos ir šlapimo nelaikymas.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’ s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Klinikini tyrim, kuriuose dalyvavo pacientai, kuriems pasireišk vaist preparat (dopamino agonist) sukelta psichoz, susijusi su Parkinsono liga, duomenimis, dažnai ir dažniau nei vartojant placeb, pasunk jo parkinsoniniai simptomai ir atsirado haliucinacij.
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.
Vieno klinikinio tyrimo, kuriame dalyvavo pacientai, kuriems sergantys bipoline manija, duomenimis, kartu su olanzapinu vartojant valproato, neutropenija pasieišk 4, 1% atvej Galimas skatinamasis veiksnys gali b ti didel valproato koncentracija plazmoje.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
Olanzapin vartojant kartu su li iu ar valproatu, dažniau pasireišk (≥ 1 0%) drebulys, burnos dži vimas, apetito ir svorio padid jimas.
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).
Olanzapin vartojant kartu su li iu ar divalproeksu, svorio padid jimas ≥ 7% pradinio svorio gydymo metu (iki 6 savai i) nustatytas 17, 4% pacient.
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
Ilgalaikis (iki 12 m nesi) olanzapino vartojimas atkry io profilaktikai pacientams, kuriems diagnozuotas bipolinis sutrikimas, 39, 9% pacient buvo susij s su k no svorio padid jimu ≥ 7% pradinio svorio.
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Vaikai ir paaugliai Olanzapinu vaikai ir jaunesni kaip 18 met paaugliai negydomi.
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.
Palyginam j paaugli ir suaugusi j gydymo klinikini tyrim neatlikta, visgi palyginti tyrim, kuriuose dalyvavo paaugliai, ir suaugusi j tyrim duomenys.
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.
Toliau esan ioje lentel je apibendrintos nepageidaujamos reakcijos, kurios dažniau pasireišk paaugliams (13- 17 met) nei suaugusiesiems ar nepageidaujamos reakcijos, kurios nustatytos tik trumpalaiki klinikini tyrim, kuriuose dalyvavo paaugliai, metu.
Clinically significant weight gain (7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Paaugliams kliniškai reikšmingai (7%) k no svoris padid jimas dažniau, negu suaugusiems žmon ms, kuri organizme ekspozicija buvo panaši.
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.
Ilgalaik s (mažiausiai 24 savai i) ekspozicijos metu pacient k no svorio padid jimo dydis ir paaugli, kuri k no svoris padid jo kliniškai reikšmingai, dalis buvo didesni, negu trumpalaik s ekspozicijos metu
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Kiekvienoje dažnio grup je nepageidaujamos reakcijos pateikiamos maž jan io sunkumo tvarka.
Very common (10%), common (1% and < 10%).
Išvardytas sutrikim dažnis apib dinamas taip: labai dažni (10%), dažni (nuo 1% iki < 10%).
Weight gain9, elevated triglyceride levels10, increased appetite.
10 Metabolizmo ir mitybos sutrikimai Labai dažni.
Elevated cholesterol levels11 Nervous system disorders Very common:
Nerv sistemos sutrikimai Labai dažni.
Sedation (including: hypersomnia, lethargy, somnolence).
Sedacija (skaitant pernelyg didel mieguistum, letargij, somnolencij).
Dry mouth Hepato-biliary disorders Very common:
Kepen, tulžies p sl s ir latak sutrikimai Labai dažni.
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
4. 4 skyri).
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
Bendrojo bilirubino koncentracijos sumaž jimas, GGT padaug jimas, prolaktino koncentracijos plazmoje padid jimas 12.
9 Weight gain 7% of baseline body weight (kg) was very common and 15% of baseline body weight was common.
9 Svorio padid jimas 7% pradinio k no svorio (kg) buvo labai dažnas, o 15% pradinio k no svorio - dažnas.
With long-term exposure (at least 24 weeks), approximately half of adolescent patients gained 15% and almost a third gained 25% of their baseline body weight.
Ilgalaik s (mažiausiai 24 savai i) ekspozicijos metu maždaug pusei paaugli k no svoris, palyginti su baziniu, padid jo 15%, apie tre daliui paaugli − 25%.
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
Vidutinis k no svorio prieaugis buvo didžiausias paaugliams, kurie, prieš pradedant gydyti, tur jo antsvor arba buvo nutuk.
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).
10 Normali pradin koncentracija nevalgius (< 1, 016 mmol/ l), kuri padid jo iki didel s (≥ 1, 467 mmol/ l), o ribin s pradin s triglicerid koncentracijos nevalgius (≥ 1, 016 - < 1, 467 mmol/ l) iki didel s (≥ 1, 467 mmol/ l).
11 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/ l) to high (5.17 mmol/ l) were observed commonly.
11 Normalios pradin s bendrojo cholesterolio koncentracijos nevalgius (< 4, 39 mmol/ l) padid jimas iki didel s (≥ 5, 17 mmol/ l) nustatytas dažnai.
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.
Ribin s pradin s bendrojo cholesterolio koncentracijos nevalgius (≥ 5, 17- 6, 2 mmol/ l) padid jimas iki didel s (≥ 6, 2 mmol/ l) buvo labai dažnas.
12 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
12 Prolaktino koncentracijos padid jimas nustatytas 47, 4% paaugli.
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.
Požymiai ir simptomai Perdozavus labai dažnai (> 10%) b na tachikardija, ažitacija/ agresyvumas, dizartrija, vair s ekstrapiramidiniai simptomai, s mon s slopinimas nuo sedacijos iki komos.
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.
Kitos kliniškai reikšmingos perdozavimo pasekm s yra klied jimas, traukuliai, koma, galimas piktybinis neurolepsinis sindromas, kv pavimo slopinimas, aspiracija, hipertenzija ar hipotenzija, širdies aritmijos (< 2% perdozavimo atvej) ir širdies bei kv pavimo sustojimas.
Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of 1,500 mg.
Pasitaik mirties atvej, kai buvo iš karto suvartota tik 450 mg, ta iau pacientas, iš karto išg r s 1500 mg, išgyveno.
Management of overdose There is no specific antidote for olanzapine.
Perdozavimo gydymas Specifinio olanzapino priešnuodžio n ra.
Induction of emesis is not recommended.
Nerekomenduojama sukelti v mim.
Standard procedures for management of overdose may be indicated (i. e. gastric lavage, administration of activated charcoal).
Reikia taikyti standartin apsinuodijimo gydym (t. y. plauti skrand, skirti aktyvintos anglies).
The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
Kartu vartojama aktyvintoji anglis 50- 60% sumažina išgerto olanzapino biologin prieinamum.
Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Atsižvelgiant klinikin b kl, b tina prad ti simptomin gydym ir steb ti gyvybines organ funkcijas, gydyti hipotenzij ir kraujotakos kolaps bei užtikrinti kv pavimo funkcij.
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta- agonist activity since beta stimulation may worsen hypotension.
Negalima vartoti epinefrino, dopamino ir kit simpatomimetik, kuriems b dingas beta agonistinis aktyvumas, nes, stimuliuojant beta adrenoreceptorius, gali sustipr ti hipotenzija.
Cardiovascular monitoring is necessary to detect possible arrhythmias.
Reikia nuolat tirti širdies ir kraujagysli sistemos b kl, kad b t nustatytos galimos aritmijos.
Close medical supervision and monitoring should continue until the patient recovers.
Pacient reikia atidžiai steb ti tol, kol išnyks simptomai
Pharmacotherapeutic group: antipsychotic, ATC code:
Farmakoterapin grup: antipsichoziniai vaistai, ATC kodas:
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Olanzapinas yra antipsichozinis, slopinantis manij ir stabilizuojantis nuotaik vaistas, pla iai farmakologiškai veikiantis daugel receptori sistem.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/ 2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α 1 adrenergic; and histamine H1 receptors.
Ikiklinikiniai olanzapino tyrimai parod, kad jis turi afinitet (Ki; < 100 nM) serotonino 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamino D1, D2, D3, D4, D5; cholinerginiams muskarino m1- m5, α1 adrenerginiams ir histamino H1 receptoriams.
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Tiriant olanzapino poveik gyv n elgsenai, nustatyta, kad jam b dingas 5 HT, dopamino ir cholinerginis antagonizmas, atitinkantis jungimosi su receptoriais profil.
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Elektrofiziologiniai tyrimai parod, kad olanzapinas selektyviai mažina mezolimbini (A10) dopaminergini neuron iškrov ir beveik neveikia motorines funkcijas reguliuojan ios dryžuotojo k no (A9) sistemos.
Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Olanzapino doz s, slopinan ios s lygin vengimo refleks (testas antipsichoziniam poveikiui vertinti), yra mažesn s negu sukelian ios katalepsij (nepageidaujamo motorikos poveikio indikatorius).
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
Atliekant “ anksiolitin ” test, skirtingai negu kai kurie kiti antipsichoziniai vaistai, olanzapinas padidina atsak.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A than dopamine D2 receptor occupancy.
Sveikiems savanoriams, išg rusiems vienkartin 10 mg olanzapino doz, pozitron emisijos tomografijos (PET) b du buvo nustatyta, kad daugiau olanzapino prisijung prie 5 HT2A receptori negu prie dopamino D2 receptori.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Be to, SPECT tyrimo su šizofrenija sergan iaisiais metu nustatyta, kad s kmingai olanzapinu gydom pacient dryžuotajame k ne buvo mažiau užimt D2 receptori negu s kmingai kitais antipsichoziniais vaistais bei risperidonu gydom ir panašiai kaip s kmingai klozapinu gydom pacient.
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.
Dviejuose iš dviej placebo ir dviejuose iš trij lyginamuosiuose kontroliuojamuose klinikiniuose tyrimuose dalyvavusiems daugiau nei 2900 šizofrenija sergantiems pacientams su teigiamais ir neigiamais simptomais olanzapinas statistiškai patikimai sumažino ir vienus, ir kitus simptomus.
In a multinational, 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).
Prospektyvi antrin nuotaikos skal s rodikli prieš gydym ir galutini tyrimo rezultat poky io analiz parod statistiškai patikim pager jim (p = 0, 001) gydant olanzapinu (- 6) palyginti su haloperidoliu (- 3, 1).
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.
Olanzapino efektyvumas buvo panašus kaip haloperidolio lyginant manijos ir depresijos simptom sumaž jimo santyk per 6 ir 12 savai i.
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.
Klinikinio tyrimo, kai buvo skiriamas litis arba valproatas mažiausiai 2 savaites, papildomai paskyrus 10 mg olanzapino (gydymas kartu su li iu arba valproatu) manijos simptom slopinimas buvo geresnis nei skiriant vien lit arba valproat 6 savaites.
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
Olanzapinas statistiškai patikimai geriau nei placebas nutrauk pirmin bipolinio sutrikimo pasikartojim.
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Taip pat olanzapinas buvo statistiškai patikimai pranašesnis už placeb užkertant keli tiek manijos, tiek depresijos pasikartojimui.
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).
Olanzapinas statistiškai patikimai ne blogiau nei litis nutrauk pirmin bipolinio sutrikimo pasikartojim (olanzapinas 30, 0%, litis 38, 3%; p = 0, 055).
12 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.
12 18 m nesi klinikinio tyrimo metu pacientams, kuriems manijos arba mišrus epizodas buvo s kmingai nuslopintas skiriant olanzapin kartu su vienu iš nuotaik stabilizuojan i vaist (li iu arba valproatu), ilgalaikis gydymas olanzapinu kartu su li iu arba valproatu nebuvo statistiškai reikšmingai pranašesnis už gydym tik li iu arba valproatu pav linant bipolin pasikartojim, apib dinam sindrominiais diagnoz s nustatymo kriterijais.
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.
Vaikai ir paaugliai Paaugli (13- 17 met) gydymo patirtis ribota ir remiasi trumpalaikiais šizofrenijos (6 savai i) ir manijos, susijusios su bipoliniu I tipo sutrikimu (3 savai i), kuriuose dalyvavo mažiau kaip 200 paaugli, gydymo veiksmingumo tyrimais.
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
Buvo vartojamos lanks ios olanzapino doz s: nuo 2, 5 iki 20 mg per par.
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Išgertas olanzapinas gerai absorbuojasi, didžiausia jo koncentracija kraujo plazmoje b na po 5- 8 valand.
Absolute oral bioavailability relative to intravenous administration has not been determined
Absoliutus išgerto vaisto biologinis sisavinimas, lyginant su pavartotu ven, nenustatytas.
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Olanzapinas metabolizuojamas kepenyse konjugacijos ir oksidacijos b du.
The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Daugiausia cirkuliuoja metabolito 10- N- gliukuronido, kuris nepraeina pro hematoencefalin barjer.
Cytochromes P450- CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Veikiant citochromams P450- CYP1A2 ir P450- CYP2D6, susidaro N- dezmetilo ir 2- hidroksimetilo metabolit.
The predominant pharmacologic activity is from the parent olanzapine.
Tyrimai su gyv nais parod, kad abu metabolitai in vivo veikia žymiai silpniau negu olanzapinas.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Sveik asmen galutinis išgerto vaisto pusin s eliminacijos periodas priklaus nuo amžiaus ir lyties.
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).
Sveik senyv pacient (65 met ir daugiau), lyginant su jaunesniais, vidutinis pusin s eliminacijos periodas buvo ilgesnis (atitinkamai 51, 8 val. ir 33, 8 val.), o klirensas mažesnis (atitinkamai 17, 5 l/ val. ir 18, 2 l/ val.).
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Senyv pacient farmakokinetikos kintamumas atitinka jaunesni pacient ribas.
In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
44 vyresniems kaip 65 met pacientams, sergantiems šizofrenija, 5- 20 mg vaisto paros doz s nebuvo susijusios su išskirtiniu nepageidaujamu poveikiu.
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/ hr).
Moter, lyginant su vyrais, vidutinis pusin s eliminacijos periodas buvo šiek tiek ilgesnis (atitinkamai 36, 7 val. ir 32, 3 val.), o klirensas mažesnis (atitinkamai 18, 9 l/ val. ir 27, 3 l/ val.).
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Ta iau olanzapinas (5- 20 mg) buvo toks pat saugus ir moterims (n = 467), ir vyrams (n = 869).
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).
Pacientams, kuriems buvo inkst nepakankamumas (kreatinino klirensas < 10 ml/ min.), lyginant su sveikaisiais, nustatyta tik neryški vidutinio pusinio eliminacijos periodo (atitinkamai 37, 7 val. ir 32, 4 val.) ir vaisto klirenso (atitinkamai 21, 2 l/ val. ir 25, 0 l/ val.) skirtum.
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Masi pusiausvyros tyrim metu nustatyta, kad 57% radioaktyvi ja medžiaga žym to olanzapino išsiskiria su šlapimu, daugiausia metabolit pavidalu.
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).
R kan i pacient, kuri neryškiai sutrikusi kepen funkcija, vidutinis pusin s eliminacijos periodas (39, 3 val.) buvo ilgesnis, o klirensas (18, 0 l/ val.) mažesnis lyginant su sveikais ner kan iais asmenimis (atitinkamai 48, 8 val. ir 14, 1 l/ val.).
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
Ner kan i pacient (vyr ir moter), lyginant su r kan iais, vidutinis pusin s eliminacijos periodas buvo ilgesnis (atitinkamai 38, 6 val. ir 30, 4 val.), o klirensas mažesnis (atitinkamai 18, 6 l/ val. ir 27, 7 l/ val.).
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
13 Olanzapino klirensas yra mažesnis senyv pacient lyginant su jaunesniais, moter lyginant su vyrais, ir ner kan i j lyginant su r kan iaisiais.
13 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Ta iau amžiaus, lyties ir r kymo taka olanzapino klirensui ir pusin s eliminacijos periodui yra nedidel lyginant su bendraisiais individ tarpusavio skirtumais.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Tiriant trij populiacij (balt j, japon ir kin) farmakokinetikos rodiklius, skirtum nenustatyta.
Olanzapine is bound predominantly to albumin and α 1-acid-glycoprotein.
Kai olanzapino koncentracija kraujyje yra 7- 1000 ng/ ml, apie 93% jo susijungia su plazmos baltymais, daugiausiai su albuminu ir α1 r gš iuoju glikoproteinu.
Paediatric population Adolescents (ages 13 to 17 years):
Vaikai ir paaugliai Paaugliai (13- 17 met).
The pharmacokinetics of olanzapine are similar between adolescents and adults.
Olanzapino farmakokinetika paaugli ir suaugusi j organizme panaši.
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Kinikini tyrim duomenimis, vidutin olanzapino ekspozicija paaugli organizme maždaug 27% didesn.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Demografiniai paaugli ir suaugusi j skirtumai yra šie: vidutinis paaugli k no svoris yra mažesnis, mažiau paaugli r ko.
Such factors possibly contribute to the higher average exposure observed in adolescents.
Šie veiksniai gali skatinti ekspozicijos padid jim paaugli organizme.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
minis (vienkartin s doz s) toksiškumas Graužikamsgeriamojo vaisto sukeltas toksiškumas buvo toks pat kaip sukeltas stipri neuroleptik: sumaž j s aktyvumas, koma, drebulys, kloniniai traukuliai, seil tekis ir nepriaug s svoris.
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Vidutin mirtina doz buvo apie 210 mg/ kg pel ms ir apie 175 mg/ kg žiurk ms.
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Šunys toleravo ir nenugaišo nuo vienkartin s doz s iki 100 mg/ kg.
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Jiems buvo ši klinikini reiškini: sedacija, ataksija, drebulys, padažn j s širdies ritmas, pasunk j s kv pavimas, mioz ir anoreksija.
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
Beždžion ms vienkartin 100 mg/ kg doz suk l prostracij, o nuo didesn s doz s pritemo s mon.
Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
CNS slopinimas, anticholinerginis poveikis ir periferinio kraujo poky iai.
Tolerance developed to the CNS depression.
CNS slopinimui pasireišk tolerancija.
Growth parameters were decreased at high doses.
Nuo dideli vaisto dozi sul t jo augimas.
Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Žiurk ms atsirado gr žtam j reiškini, susijusi su padid jusiu prolaktino kiekiu: sumaž jo kiaušidži ir gimdos svoris, morfologiškai pakito makšties ir pieno liaukos epitelis.
Haematologic toxicity:
Hematologinis toksiškumas Vis r ši gyv nams pakito kraujo rodikliai.
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Tai ir nuo doz s priklausantis cirkuliuojan i leukocit skai iaus sumaž jimas pel ms ir nespecifinis cirkuliuojan i leukocit skai iaus sumaž jimas žiurk ms, ta iau citotoksinio vaisto poveikio kaul iulpams nenustatyta.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Keliems šunims, gavusiems 8 mg/ kg ar 10 mg/ kg per par (bendra olanzapino ekspozicija [AUC] 12- 15 kart didesn negu skiriant 12 mg doz žmogui), nustatyta laikina neutropenija, trombocitopenija ar anemija.
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Šun, kuri kraujyje buvo nustatyta citopenija, kaul iulp kamienin s ir proliferuojan ios l stel s buvo nepakitusios.
Reproductive toxicity Olanzapine had no teratogenic effects.
Reprodukcinis toksiškumas Olanzapinas neveik teratogeniškai.
Sedation affected mating performance of male rats.
Raminamasis poveikis tur jo takos žiurki patin poravimuisi.
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
1, 1 mg/ kg doz (3 kartus didesn už didžiausi žmogaus doz) veik žiurki estrogeninius ciklus, 3 mg/ kg doz (9 kartus didesn už didžiausi žmogaus doz) reprodukcij.
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
Žiurki, kurios gavo olanzapino, palikuoni fetalin raida sul t jo, j aktyvumas laikinai sumaž jo.
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.
Mutageniškumas Standartiniais tyrimais, iš j bakterij mutacijos testais bei in vitro ir in vivo žinduoli testais, mutageninio ar klastogeninio olanzapino poveikio nenustatyta.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Kancerogeniškumas vertinus tyrim su žiurk mis ir pel mis rezultatus, galima teigti, kad olanzapinas n ra kancerogeniškas.
Gelatin Mannitol (E421) Aspartame (E951) Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217)
Želatina Manitolis (E421) Aspartamas (E951) Metilo parahidroksibenzoato natrio druska (E219) Propilo parahidroksibenzoato natrio druska (E217)
Not applicable.
Duomenys neb tini
Store in the original package in order to protect from light and moisture.
Laikyti gamintojo pakuot je, kad preparatas b t apsaugotas nuo šviesos ir dr gm s.
Aluminium blister strips in cartons of 28, 35, 56 or 70 orodispersible tablets per carton.
Kartono d žut, kurioje yra 28, 35, 56 arba 70 burnoje disperguojam j table i, supakuot aliuminio lizdines plokšteles.
3 February 2000 Date of latest renewal:
2000 02 03 Rinkodaros teis s atnaujinimo data:
ZYPREXA VELOTAB 10 mg orodispersible tablets
ZYPREXA VELOTAB 10 mg burnoje disperguojamosios tablet s
Each orodispersible tablet contains 10 mg olanzapine.
Vienoje burnoje disperguojamoje tablet je yra 10 mg olanzapino.
Each orodispersible tablet contains 0.80 mg aspartame, 0.15 mg sodium methyl parahydroxybenzoate, 0.05 mg sodium propyl parahydroxybenzoate.
0, 8 mg aspartamo 0, 15 mg metilo parahidroksibenzoato natrio druskos 0, 05 mg propilo parahidroksibenzoato natrio druskos.
Yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration.
Geltonos, apvalios, tai šalto džiovinimo b du paruoštos, greitai disperguojan ios, gali b ti dedamos burn arba tirpinamos vandenyje ar kitame tinkamame g rime.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Suaugusieji Olanzapinas veiksmingas palaikomajam gydymui, pager jus klinikinei b klei tiems pacientams, kuriems pradinis gydymas buvo efektyvus.
The recommended starting dose for olanzapine is 10 mg/ day.
Rekomenduojama pradin olanzapino doz yra 10 mg per par.
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.
Šizofrenijos, manijos epizodo gydymo ir bipolinio sutrikimo pasikartojim profilaktikos metu paros doz gali b ti palaipsniui koreguojama pagal ligonio klinikin b kl nuo 5 mg iki 20 mg per par ribose.
An increase to a dose greater than the recommended starting dose is advised only after
Didinti doz iki didesn s nei rekomenduojama pradin patariama tik kruopš iai kartotinai vertinus klinikin ligonio b kl ir paprastai turi b ti atliekamas ne trumpesniais kaip 24 valand
16 appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
16 intervalais.
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Lytis Moterims pradin s doz s ir dozi interval paprastai nereikia keisti.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
R kymas Ner kantiems pacientams pradin s doz s ir dozi interval paprastai nereikia keisti.
17 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.
17 sutrikim rizika.
1.5%, respectively).
Placebo kontroliuojam klinikini tyrim metu (6- 12 savai i trukm s) su senyvais (vidutinis amžius 78 metai) sergan iais demencija su psichoze ir (arba) elgesio sutrikimais pacientais, gydyt olanzapinu pacient mir i dažnis buvo 2 kartus didesnis nei gavusi placeb (atitinkamai 3, 5%, palyginti su 1, 5%).
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
T pa i klinikini tyrim metu buvo nepageidaujam cerebrovaskulini reiškini (NCVR t. y. insultas, praeinantysis išemijos priepuoliai), skaitant mirties atvejus.
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Piktybinis neurolepsinis sindromas (PNS) PNS - tai gyvybei pavojingas b kl, kuri sukelia antipsichoziniai vaistiniai preparatai.
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).
(žr.
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Kai kuriems iš j prieš tai padid jo k no svoris, kas gal jo b ti predisponuojan i veiksni.
18 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Anticholinerginis poveikis Olanzapinas in vitro veikia anticholinergiškai, ta iau klinikini tyrim patirtis rodo, kad ši reiškini b na retai.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
18 Kepen funkcija Dažnai, ypa gydymo pradžioje, buvo stebimas laikinas besimtominis kepen transaminazi (ALAT, ASAT) aktyvumo padid jimas.
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.
QT intervalas Klinikini tyrim metu kliniškai reikšmingas QTc intervalo pailg jimas (Fridericia QT korekcija [QTcF] 500 milisekundži [msek] bet kuriuo metu po bazinio dydžio nustatymo pacientams, kuri bazinis QTcF < 500 msek) olanzapinu gydytiems pacientams buvo nedažnas (nuo 0, 1% iki 1%), palyginti su placebu joki reikšming su tuo susijusi nepageidaujam širdies reiškini skirtum, palyginant su placebu, nebuvo.
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.
Bendrasis CNS aktyvumas Olanzapinas tiesiogiai veikia CNS, tod l ypa atsargiai j reikia vartoti kartu su kitais centrinio poveikio vaistiniais preparatais ir alkoholiu.
19 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
V lyvoji diskinezija Vieneri met ir trumpesni lyginamieji tyrimai parod, kad olanzapinas statistiškai patikimai re iau sukelia diskinezij.
However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
V lyvosios diskinezijos rizika did ja gydant ilgai, tod l, atsiradus jos požymi ms, reikia spr sti, ar mažinti vaisto doz ar jo nebevartoti.
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Šie simptomai gali laikinai pablog ti ar net ir atsirasti nutraukus.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
19 Ortostatin hipotenzija Olanzapino klinikini tyrim metu kai kuriems senyviems pacientams steb ta ortostatin hipotenzija.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
CYP1A2 indukcija Olanzapino metabolizm gali greitinti r kymas ir karbamazepinas, tai gali mažinti šio vaisto koncentracij.