qanastek/EMEA-V3 huggingface dataset:
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
buvo ilgesnis (atitinkamai 38, 6 val. ir 30, 4 val.), o klirensas mažesnis (atitinkamai 18, 6 l/ val. ir 27, 7 l/ val.).
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Tač amž
There was a 3-fold increase in CVAE in patients treated
kanč jų kanč
0.4%, respectively).
iaus, lyties ir rū
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
taka
The efficacy of olanzapine was not established in these trials.
ir pusinė eliminacijos periodui yra nedidelė
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
s
Rare cases reported as NMS have also been received in association with olanzapine.
lyginant su bendraisiais individų tarpusavio skirtumais.
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Tiriant trijųpopuliacijų baltų, japonų kinų - farmakokinetikos rodiklius, skirtumų
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
(-
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
jų
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
ir
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.
)
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.
nenustatyta.
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.
Kai olanzapino koncentracija kraujyje yra 7 - 1000 ng/ ml, apie 93% jo susijungia su plazmos baltymais, daugiausiai su albuminu ir  rū č 1 gšiuoju glikoproteinu.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
Vaikai ir paaugliai Paaugliai (13- 17 metų Olanzapino farmakokinetika paauglių suaugusių
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
).
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.
ir
In most of these cases, a history of seizures or risk factors for seizures was reported.
jųorganizme panaši.
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.
Kinikinių tyrimų duomenimis, vidutinėolanzapino ekspozicija paaugliųorganizme maždaug 27% jųskirtumai yra š vidutinis paaugliųkū svoris yra didesnėDemografiniai paaugliųir suaugusių
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
ie:
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
no
75 Lactose Zalasta tablets contain lactose.
esnis, maž paauglių ko.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Š veiksniai gali skatinti ekspozicijos padidė paauglių maž organizme.
4.5 Interaction with other medicinal products and other forms of interaction
65 5. 3 Ikiklinikiniųsaugumo tyrimųduomenys
Interaction studies have only been performed in adults.
Ū minis (vienkartinė dozė toksiš
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.
kumas
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Grauž ikams geriamojo vaisto sukeltas toksiš kumas buvo toks pat kaip sukeltas stipriųneuroleptikų: ės sumažję aktyvumas, koma, drebulys, kloniniai traukuliai, seilė tekis ir nepriaugęsvoris.
Only slight to moderate increase in olanzapine clearance has been observed.
Š mirtina dozė
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).
iurkė
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
unys toleravo ir nenugaiš o
The mean increase in olanzapine AUC was 52% and 108% respectively.
nuo vienkartinė dozė iki 100 mg/ kg.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Jiems buvo š klinikinių kinių sedacija, ataksija, drebulys, padaž ję š
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
ių
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.
reiš:
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Bež ionė vienkartinė
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
sukė
1A2, 2D6, 2C9, 2C19, 3A4).
prostracijąo nuo didesnė lė,
Olanzapine showed no interaction when co-administered with lithium or biperiden.
dozė pritemo są s s
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
monė
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
.
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).
Kartotiniųdozių toksiškumas tyrimų ž mis bei š Trijų nesių
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
mė
76 4.6 Pregnancy and lactation
tyrimų pelė ir
Pregnancy:
vienerių
There are no adequate and well-controlled studies in pregnant women.
su iurkė
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.
unimis metu buvo nustatyti
Lactation:
š vyraujantys poveikiai:
In a study in lactating, healthy women, olanzapine was excreted in breast milk.
CNS slopinimas, anticholinerginis poveikis ir periferinio kraujo pokyč ie iai.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
CNS slopinimui pasireiš tolerancija.
Patients should be advised not to breast feed an infant if they are taking olanzapine.
Ž
4.7 Effects on ability to drive and use machines
kė
No studies on the effects on the ability to drive and use machines have been performed.
sulė jo
4.8 Undesirable effects
iurkė atsirado ms
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.
ė
Very common (≥
grį tamų
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
jusiu prolaktino kiekiu: sumažjo kiauš ių gimdos svoris, idž ir
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
morfologiš pakito makš ir pieno liaukos epitelis.
Very common
kai
Common
ties
Uncommon
kumas.
Not known
rūių
Blood and the lymphatic system disorders Immune system disorders
Tai ir nuo dozė s ė
Eosinophilia
priklausantis cirkuliuojanč leukocitų
Leukopenia Neutropenia
ių
Thrombocytopenia Allergic reaction
skaičiaus sumažjimas pelė ir nespecifinis cirkuliuojanč ms
Metabolism and nutrition
skaič sumažjimas ž ė leukocitų
disorders
iaus
Weight gain1
iulpams
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
Keliems š unims, gavusiems 8 mg/ kg ar 10
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
mg/ kg per parą ž
Nervous system disorders Somnolence
(bendra olanzapino ekspozicija
Dizziness Akathisia6
[AUC] 12- 15 kartųdidesnė
Seizures where in most cases a history of
negu skiriant 12 mg dozę mogui), nustatyta laikina neutropenija,
77
Š
Cardiac disorders
, kurių
Parkinsonism6 Dyskinesia 6
kraujyje buvo nustatyta citopenija, kaulų
seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
iulpų
Vascular disorders
kamieninės
Bradycardia QT c prolongation (see section 4.4)
ir proliferuojanč lą s buvo nepakitusios. ios stelė
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Reprodukcinis toksiškumas teratogeniš Raminamasis poveikis turė į jo takos ž Olanzapinas neveikė
Orthostatic hypotension
iurkiųpatinų poravimuisi.
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
už iausią mogaus dozę veikė iurkių)
Gastrointestinal disorders
estrogeninius ciklus,
Mild, transient anticholinergic effects including constipation and dry mouth
už iausią mogaus dozę - reprodukcijąŽ ž 3 mg/ kg dozė kartus didesnė didž
Pancreatitis
)
Hepato-biliary disorders
. iurkių kurios gavo,
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
ė olanzapino, palikuoniųfetalinė raida sulė jo, jų
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
tė
Skin and subcutaneous tissue disorders
aktyvumas laikinai sumažjo.
Rash
Mutageniš
Photosensitivity reaction Alopecia
kumas
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
jųbakterijųmutacijos testais bei in vitro ir in vivo ž Standartiniais mutageninio ar
High creatine phosphokinase Increased total bilirubin
tyrimais, iš klastogeninio olanzapino poveikio nenustatyta.
Increased alkaine phosphatase
induoliųtestais,
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Įvertinus tyrimų ž mis ir pelė rezultatus, galima teigti, kad olanzapinas nė
15% of baseline body
su iurkė
78
ra
weight was common.
kancerogeniš kas.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
Laktozė monohidratas s Celiuliozė milteliai s Pregelifikuotas kukurū krakmolas zų Kukurū krakmolas zų Koloidinis silicio dioksidas, bevandenis Magnio stearatas
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
6. 2 Nesuderinamumas
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
6. 4 Specialios laikymo są lygos
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Š vaistiniam preparatui specialių iam laikymo są lygųnereikia.
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
6. 5 Pakuotė jos turinys ir
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.
ž, Dėutėkurioje yra 14, 28, 35, 56 or 70 tableč OPA/ Al/ PVC ir aliuminio folijos lizdinė plokš mis. telė
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. 6 Specialū reikalavimai atliekoms tvarkyti s
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Nesuvartotąpreparatą atliekas reikia tvarkyti laikantis vietinių
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.
TOJAS
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovė
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
8.
In most patients, levels returned to normal ranges without cessation of treatment.
RINKODAROS TEISĖ NUMERIS (- IAI) S
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.
EU/ 1/ 07/ 415/ 022- 026
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
RINKODAROS TEISĖ SUTEIKIMO / ATNAUJINIMO DATA S
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.
2007 09 27. s
Olanzapine administered with lithium or valproate resulted in increased levels ( 10%) of tremor, dry mouth, increased appetite, and weight gain.
10.
Speech disorder was also reported commonly.
TEKSTO PERŽ ROS DATA IŪ
79 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
apie špreparatą į Naujausią samią
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.
iš
The frequency terms listed are defined as follows:
informaciją
Very common (≥ 10%), common (≥ 1% and < 10%).
galite rasti Europos vaistųagentū (EMEA) ros
Metabolism and nutrition disorders Very common:
interneto svetainė http: // www. emea. europa. eu /. je
11 Common:
67 1.
Gastrointestinal disorders Common:
VAISTINIO PREPARATO PAVADINIMAS
4.9 Overdose
Zalasta 20 mg tabletė s
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.
KOKYBINĖIR KIEKYBINĖSUDĖTIS
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.
Kiekvienoje tabletė yra 20 mg olanzapino. je
80 Management of overdose There is no specific antidote for olanzapine.
Pagalbinėmedž iaga:
Induction of emesis is not recommended.
Kiekvienoje tabletė yra 323, 5 mg laktozė
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.
je
5.
s.
5.1 Pharmacodynamic properties
Visos pagalbinė medž
Pharmacotherapeutic group: antipsychotics: diazepines, oxazepines and thiazepines, ATC code:
s
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
iagos iš vardytos 6. 1 skyriuje.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
FARMACINĖFORMA
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.
Tabletė.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition
Tabletė yra apvalios, š tiek abipus iš
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.
s
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.
iek
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).
gaubtos, gelsvos, ant jųgali bū pavieniųgeltonų mių ti dė,
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.
yra už
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
as „ 20 “.
5.2 Pharmacokinetic properties
raš
The absorption is not affected by food.
KLINIKINĖINFORMACIJA
The major circulating metabolite is the 1 0-N-glucuronide, which does not pass the blood brain barrier.
4. 1 Terapinė indikacijos s
The predominant pharmacologic activity is from the parent olanzapine.
Suaugusieji Olanzapino skiriama š izofrenijai gydyti.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Olanzapinas veiksmingas palaikomajam gydymui, pagerė klinikinei bū tiems pacientams, kuriems pradinis gydymas buvo efektyvus.
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Olanzapino skiriama vidutinio sunkumo ir sunkiųmanijos epizodųgydymui.
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.
Pacientams, kuriems manijos epizodų
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/ hr).
gydymas olanzapinu buvo sėkmingas, olanzapinas vartojamas
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
bipolinio sutrikimo pasikartojimo profilaktikai (ž 5. 1 skyrių
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).
Rekomenduojama pradinėolanzapino dozė 10 mg per parą
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).
yra
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).
.
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Pradinėolanzapino dozė 15 mg vieną
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
–
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
kartą parą per gydant tik juo ir 10 mg per
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
parąskiriant kombinuotą gydymą r.
1
5. 1 skyrių
Paediatric population Adolescents (ages 13 to 17 years):
(ž
5.3 Preclinical safety data
).
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Bipolinio sutrikimo pasikartojimo profilaktika.
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Rekomenduojama pradinė dozė 10 mg per parą
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
yra
Growth parameters were decreased at high doses.
.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Pacientams, kurių manijos epizodas yra gydomas olanzapinu, bipolinio sutrikimo pasikartojimo profilaktinis gydymas tęsiamas ta pač doze.
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Jei pasireiš nauji manijos, miš s arba depresijos
Reproductive toxicity Olanzapine had no teratogenic effects.
kia
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.
rū
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
epizodai, gydymą olanzapinu reikia tę (jei reikia koregavus dozę kartu su papildomu nuotaikos
6.
sti
PHARMACEUTICAL PARTICULARS
simptomųgydymu, atsiž
6.1 List of excipients
kliniką.
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
Š izofrenijos, manijos epizodo gydymo ir bipolinio sutrikimo pasikartojimų
6.2 Incompatibilities
profilaktikos metu paros
Not applicable.
gali ti
6.3 Shelf life
bū i
2 years.
ribose.
6.4 Special precautions for storage
patariama tik kruopšiai kartotinai
This medicinal product does not require any special storage conditions.
įvertinus klinikinę ligonio bū ir paprastai turi bū atliekamas ne trumpesniais kaip 24 valandų
6.5 Nature and contents of container
Olanzapiną
Blister pack (OPA/ Al/ PVC, Al-foil):
galima skirti nepriklausomai nuo valgio, kadangi maistas neveikia jo
14, 28, 35, 56 or 70 tablets in a box.
Nutraukti gydymą
Not all pack sizes may be marketed.
olanzapinu reikia palaipsniui mažinant dozę.
6.6 Special precautions for disposal
Vaikai ir paaugliai
Any unused product or waste material should be disposed of in accordance with local requirements.
Olanzapino nerekomenduojama vartoti vaikams ir jaunesniems kaip 18 metųpaaugliams, nes duomenų
MARKETING AUTHORISATION HOLDER
Trumpalaikių
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
nustatytas didesnis svorio padidė jimas, didesni lipidųir prolaktino koncentracijos pokyč nei tyrimų iai su suaugusiais pacientais metu (ž 4. 4, 4. 8, 5. 1 ir 5. 2 skyrius). r.
8.
iaus
MARKETING AUTHORISATION NUMBER(S)
esnė pradinė dozė mg per parąpaprastai nerekomenduojama, (5)
EU/ 1/ 07/ 415/ 027-031
velgiant į tikrus klinikinius faktorius, ją tač atsiž
9.
tam
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
kartais tenka skirti 65 metųir vyresniems
Date of first authorisation:
pacientams. (ž 4. 4 skyrių
27 September 2007.
r.
84 10.
).
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Inkstų (ar) kepenų
85 1.
ir
NAME OF THE MEDICINAL PRODUCT
funkcijos sutrikimas
Zalasta 5 mg orodispersible tablets
Š iems pacientams rekomenduojama skirti maž (5 mg) pradinę
2.
esnę
QUALITATIVE AND QUANTITATIVE COMPOSITION
dozęEsant vidutinio laipsnio.
Each orodispersible tablet contains 5 mg olanzapine.
kepenųnepakankamumui (cirozėA ar B Child- Pugh klasė reikia skirti 5 mg pradinę galima didinti labai atsargiai.
Excipient:
dozękurią,
Each orodispersible tablet contains 0.50 mg aspartame.
intervalųnereikia keisti.
For a full list of excipients, see section 6.1.
(moteriš lytis, senyvas amž ka
3.
ti
PHARMACEUTICAL FORM
s pradinė dozė snė s
Orodispersible tablet.
Prireikus tokiems pacientams s
Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
dozę galima atsargiai didinti.
CLINICAL PARTICULARS
(Ž 4. 5 ir 5. 2 skyrius). r.
4.1 Therapeutic indications
4. 3 Kontraindikacijos
Adults Olanzapine is indicated for the treatment of schizophrenia.
Padidė s jautrumas veikliajai arba bet kuriai pagalbinei medž
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Pacientai, kuriems nustatyta už kampo glaukomos rizika. daro
Olanzapine is indicated for the treatment of moderate to severe manic episode.
Antipsichoziniais vaistais gydomųpacientų klinikinė klė pagerė tik po keliųdienų savaič.
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).
Su demencija susijusios psichozė ir (arba) elgesio sutrikimai s Olanzapinas nė patvirtintas su demencija susijusiųpsichoziųir (arba) elgesio sutrikimų
4.2 Posology and method of administration
nerekomenduojamas bū š grupė pacientams, nes padidė mirtingumas ir cerebrovaskulinių
Adults Schizophrenia:
Placebo kontroliuojamų
The recommended starting dose for olanzapine is 10 mg/ day.
klinikiniųtyrimųmetu (6- 12 savaič trukmė su senyvais ių s)
Manic episode:
(vidutinis
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
psichoze ir (arba) elgesio sutrikimais pacientais,
Preventing recurrence in bipolar disorder:
gydytųolanzapinu pacientųmirč daž buvo 2 kartus didesnis nei gavusių
The recommended starting dose is 10 mg/ day.
3, 5%, palyginti su 1, 5%).
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Š grupė pacientų
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.
olanzapinu gali lemti tokie rizikos veiksniai kaip amž > 65 metų disfagija, sedacija, mitybos
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.
Tač mirč daž olanzapinu gydytųpacientų
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.
tyrimųmetu buvo nepageidaujamųcerebrovaskulinių kinių emijos priepuoliai), į
86 Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapinu gydytiems pacientams
Gradual tapering of the dose should be considered when discontinuing olanzapine.
(atitinkamai 1, 3%, palyginti su 0, 4%).
Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
vartojępacientai, patyrę cerebrovaskuliniųreiš, turė rizikos veiksnių kinių jo
Removal of the intact orodispersible tablet from the mouth is difficult.
69 Buvo pripaž kad > 75 metų ius ir kraujagyslinė miš demencija gydant olanzapinu yra
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
NCVR rizikos veiksniai.
Alternatively, it may be dispersed in a full glass of water immediately before administration.
Š tyrimųmetu olanzapino veiksmingumas nebuvo nustatytas. ių
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Parkinsono liga Olanzapino nerekomenduojama skirti dopamino agonistųsukeltoms psichozė gydyti Parkinsono ms liga sergantiems pacientams.
It has the same dosage and frequency of administration as olanzapine tablets.
Klinikiniųtyrimųmetu pastebė kad skiriant olanzapiną
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
nei placebo grupė (ž 4. 8 skyrių Parkinsono ligos simptomai niau je r.)
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.
Š iųklinikinių
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).
nebuvo veiksmingesnis, palyginti su placebu, gydant psichozė tyrimų metu iš anksto buvo reikalaujama, kad ligos bū bū
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).
klė tųstabili vartojant maž iausias veiksmingas vaistinių preparatų Parkinsono ligai gydyti (dopamino agonistų) dozes ir visųklinikinių
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
metu nebūtųkeič nei vaistiniai preparatai Parkinsono ligai gydyti, iami
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.
nei jųdozė Gydymas olanzapinu buvo pradė nuo 2, 5 mg per parą tyrė nuož ra titruojamas iki
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
iū
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
didž iausios 15 mg paros dozė
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.
Piktybinis neurolepsinis sindromas (PNS) sukelia antipsichoziniai vaistiniai preparatai.
Dose escalation, when indicated, should be conservative in such patients.
Ž PNS - tai gyvybei pavojingas bū, kurią atvejai, kai šsindromą
In cases where dose increments of 2.5 mg are considered necessary, Zalasta tablets should be used.
PNS kliniš pasireiš hiperpireksija, raumenų lė kai kia
(See sections 4.5 and 5.2.)
irdies ritmo sutrikimu).
4.3 Contraindications
kreatino ti
Hypersensitivity to the active substance or to any of the excipients.
fosfokinazėkoncentracija, pasireikš mioglobinurija (rabdomiolizė ir ū
Patients with known risk for narrow-angle glaucoma.
Pasireiš klinikiniams PNS simptomams ar be priež
4.4 Special warnings and precautions for use
antipsichoziniųvaistinių
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
preparatųį, skaitant olanzapinąvartojimą
Patients should be closely monitored during this period.
reikia nutraukti.
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.
Retai olanzapinu gydomiems pacientams pastebė hiperglikemija ir/ arba cukrinio diabeto ta išsivystymas arba pasunkė eiga, retkarč su ketoacidoze ar koma; pasitaikė
In placebo-controlled clinical trials (6-12 weeks
(ž 4. 8 skyrių Kai kuriems iš prieš padidė kū svoris, kas galė bū predisponuojanč
87 duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
Pacientus, serganč cukriniu diabetu arba turinč diabeto rizikos veiksniųkuriems
1.5%, respectively).
, rekomenduojama atidž
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
4. 8 skyrių Lipidų
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.
kontroliuoti, ypatingai tiems pacientams, kuriems yra dislipidemija ir turintiems lipidųsutrikimų rizikos veiksnių.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Anticholinerginis poveikis Olanzapinas in vitro veikia anticholinergiš tač klinikiniųtyrimųpatirtis rodo, kad š reiš
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
ligomis, todėjį l reikia atsargiai skirti tiems asmenims, kuriems yra prostatos hipertrofija, paralyž inis ž arnųnepraeinamumas ar panašbū. i klė
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
gydymo pradž buvo stebimas laikinas besimptominis kepenų
0.4%, respectively).
ASAT) aktyvumo padidė
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Atsargiai vaistą skirti pacientams, kuriems padidė s
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
funkcijos sutrikimo simptomų bū
The efficacy of olanzapine was not established in these trials.
, susijusi su ribotu kepenų, klė
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
funkcijos rezervu, taip pat gydomiems hepatotoksiš vaistais.
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.
Jeigu, gydant š vaistu, nustatomas padidė s ALAT ir (ar) ASAT aktyvumas, reikia tyrimą
In these trials, patients wer e initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
maž dozęDiagnozavus hepatitą skaitant hepatoceliuliarinęcholestazinę miš kepenų
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
olanzapinu nutraukti.
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Neutropenija Olanzapino atsargiai skiriama pacientams, kuriųleukocitų (ar) neutrofilų
Rare cases reported as NMS have also been received in association with olanzapine.
skaič dėbet kokios ius l
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).
priežasties yra sumažję vartojantiems neutropeniją sukelianč vaistinius preparatus, pacientams, ius č kuriems anksč yra buvę vaistinių
Additi onal signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
preparatųsukeltas kaulų iulpųslopinimas (toksiš kumas) arba
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.
kaulų iulpųslopinimą sukė kita liga, spindulinis gydymas ar chemoterapija, taip pat tiems
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).
asmenims, kuriems yra hipereozinofilinė bū s ar mieloproliferacinė
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
su valproatu, daž pastebė neutropenija (ž 4. 8 skyrių
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.
).
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
Gydymo nutraukimas olanzapinu, labai retai (< 0, 01%) nustatyta ū Staigiai nutraukus gydymą prakaitavimas, nemiga, drebulys, nerimas, pykinimas ar vė mimas.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
QT intervalas Klinikinių tyrimų metu kliniš reikš
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
[QTcF] ≥500 milisekundž [msek] bet kuriuo metu po bazinio dydž nustatymo pacientams, kurių
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.
bazinis QTcF < 500 msek) olanzapinu gydytiems pacientams buvo nedaž (nuo 0, 1% iki 1%), jokių nas reikšmingų tuo susijusių
88 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
irdies reiš kiniųskirtumų palyginant su placebu, nebuvo.,
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.
Tač olanzapinąkaip ir visus antipsichozinius vaistinius preparatus, reikia atsargiai skirti kartu su
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
vaistais, ilginanč QTc intervaląypač
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
senyviems pacientams, taip pat asmenims, kuriems yra
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.
įgimtas ilgo QT sindromas, stazinis širdies nepakankamumas, š irdies hipertrofija, hipokalemija ar hipomagnezemija.
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Tromboembolija Gauta labai retųpraneš
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.
imų (< 0, 01%) apie tai, kad gydymas olanzapinu laikinai buvo susiję su venų s
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.
astinio ryš
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
tarp gydymo olanzapinu ir venųtromboembolijos nenustatyta. io
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
izofrenija sergantys pacientai daž turi venųtromboembolijos rizikos nai
89 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
tyrimųmetu kai kuriems senyviems pacientams stebė ortostatinė ta hipotenzija.
Aspartame Zalasta orodispersible tablets contain aspartame, a source of phenylalanine.
Laktozė Zalasta tabletė yra laktozė Pacientams, kuriems yra retas paveldimas galaktozė netoleravimas,
May be harmful for people with phenylketonuria.
s kumas arba gliukozė ir galaktozė malabsorbcija š vaistinio preparato vartoti Lapp laktazė trū negalima.
Interaction studies have only been performed in adults.
71 Są veikos tyrimai atlikti tik suaugusiesiems.
90 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Stebint terapinęvalproato plazmos koncentracijąnenustatyta, kad reikė tųkoreguoti valproato dozę pradė kartu skirti olanzapiną
4.6 Pregnancy and lactation
Nėtumo laikotarpis.
Spontaneous reports have been ver y rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
š Buvo gauti labai reti pavieniai pranešimai, kad kū dikiams, kuriuos pagimdė
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appet ite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
padidėjimas, eozinofilija, prolaktino, cholesterolio, gliukozė ir trigliceridų padidėjimas (ž 4. 4 skyrių gliukozurija, apetito padidė
91 Metabolism and nutrition disorders Weight gain1
kartais pasireiškiantis ketoacidoze ar koma, į
Dizziness Akathisia6
Traukuliai, kurių
6
Akatizija 6
seizures or risk factors
daugeliu atvejųatsirado
Dyskinesia
Parkinsonizmas Diskinezija 6
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
pacientams, kuriems anksč buvo iau traukulių arba nustatyta rizikos veiksnių Piktybinis neurolepsinis sindromas (ž 4. 4 r. skyrių) Distonija (įskaitant okulogiraciją) Vė lyvoji diskinezija Nutraukimo simptomai 7
Hepato-biliary disorders
Kepenų tulž pū s ir latakųsutrikimai
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Trumpalaikis, simptomų nesukeliantis
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
4. 4 skyrių)
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders
Metabolizmo ir mitybos sutrikimai Rabdomiolizė Inkstųir š lapimo takųsutrikimai Sunkumas radė ti šlapintis Lytinė sistemos ir krū sutrikimai
92 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
Bendrieji sutrikimai ir vartojimo vietos paž eidimai Astenija Nuovargis Edema Tyrimai Š Prolaktino
High creatine phosphokinase Increased total bilirubin
Kreatino fosfokinazė s
Increased alkaine phosphatase
arminė fosfatazė s s
Weight gain ≥ 7% of baseline body weight was very common and ≥
suaktyvė jimas
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Palyginamųjųpaauglių suaugusių
Common:
jimas.
Elevated cholesterol levels11 Nervous system disorders Very common:
Nervų sistemos sutrikimai Labai daž Sedacija (į
94 Signs and symptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Pož ymiai ir simptomai itacija/ agresyvumas, dizartrija, į s Perdozavus labai daž (> 10%) bū tachikardija, až
Management of overdose There is no specific antidote for olanzapine.
Perdozavimo gydymas Specifinio olanzapino priešnuodž nė Nerekomenduojama sukelti vė
95 In a multinationational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
Tarptautiniame palyginamajame klinikiniame tyrime, atliktame dvigubai aklu bū dalyvavo 1481 du, pacientas, sergantis šizofrenija, šizoafektiniu ar panaš sutrikimu, kuriems buvo į
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.
Klinikinio tyrimo, kai buvo skiriamas litis
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.
arba valproatas maž iausiai 2 savaites, papildomai paskyrus 10 mg olanzapino (gydymas kartu su lič iu arba valproatu) manijos simptomų savaites.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
saugumą riboti (ž 4. 4 ir 4. 8 skyrius). r.
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Absoliutus iš
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
lyginant su pavartotu į, nenustatytas. veną
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
P450- CYP1A2 ir P450- CYP2D6, susidaro N- dezmetilo ir 2- hidroksimetilo metabolitų Tyrimai su. gyvū parodėkad abu metabolitai in vivo veikia ž
The absorption is not affected by food.
ymiai silpniau negu olanzapinas.
Absolute oral bioavailability relative to intravenous administration has not been determined.
Todėl