qanastek/EMEA-V3 huggingface dataset:
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
kymas ir karbamazepinas, kurie gali maž olanzapino inti
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Fluoksetinas (CYP2D6 inhibitorius), vienkartinėantacidinių ar cimetidino dozė reikš
20 4.6 Pregnancy and lactation
20
There are no adequate and well-controlled studies in pregnant women.
nė pakankamai duomenųapie š vaisto poveikįmogaus vaisiui, todėnėč
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
tik tuomet, kai laukiamas nauda pateisins galimąrizikąvaisiui.
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
š Buvo gauti labai reti pavieniai pranešimai, kad kū dikiams, kuriuos pagimdė
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.
vartojusios moterys, atsirado tremoras, hipertonija, letargija ir mieguistumas.
In a study in lactating, healthy women, olanzapine was excreted in breast milk.
Žindymo laikotarpis.
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
koncentracijos jimas 4
Weight gain ≥ 7% of baseline body weight was very common and ≥
arminė fosfatazė s s
15% of baseline body
suaktyvėjimas
weight was common.
plazmoje padidė
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
Bendrojo bilirubino koncentracijos padidėjimas
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Papildoma informacija apie specialių Klinikiniai tyrimai, kuriuose dalyvavo
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
grupių pacientus demencija sergantys senyvi pacientai, parodė ių mirč ir
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
cerebrovaskuliniųnepageidaujamųreakcijųpadaž jimą
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
gydant olanzapinu, palyginti su placebo
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.
vartojimu (ž 4. 4 skyrių Labai daž nepageidaujamos reakcijos, susijusios su olanzapino
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Daž pasireiš
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
jimas, letargija, eritema, regos haliucinacijos ir š pneumonija, kū temperatū padidė nelaikymas.
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.
lapimo
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Klinikiniųtyrimųkuriuose dalyvavo pacientai, kuriems pasireiš vaistų
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
(dopamino agonistų sukelta)
In most patients, levels returned to normal ranges without cessation of treatment.
psichozėsusijusi su Parkinsono liga, duomenimis, daž ir daž nei vartojant placebąpasunkė
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
parkinsoniniai simptomai ir atsirado haliucinacijų.
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Vieno klinikinio tyrimo, kuriame dalyvavo pacientai, sergantys bipoline manija, duomenimis, kartu su olanzapinu vartojant valproato, neutropenija pasieiš 4, 1% atvejų Galimas skatinamasis veiksnys gali bū didelė
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
valproato koncentracija plazmoje.
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Olanzapiną
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.
vartojant kartu su lič ar valproatu, iu
23 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Palyginamųjųpaauglių suaugusių
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
24 Management of overdose There is no specific antidote for olanzapine.
Perdozavimo gydymas Specifinio olanzapino priešnuodž nė Nerekomenduojama sukelti vė
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Tyrimais nustatyta, kad in vitro olanzapino afinitetas didesnis serotonino 5HT2 negu dopamino D2 receptoriams, in vivo - ryškesnis poveikis serotonino 5HT2 negu dopamino D2 receptoriams.
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
25 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.
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Bendrojo cholesterolio, MTL cholesterolio, trigliceridųir prolaktino koncentracijų
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Duomenų
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Išgertas olanzapinas gerai absorbuojasi, didž iausia jo koncentracija kraujo plazmoje bū po 5- 8 na gerto vaistinio preparato biologinis į valandų Maistas absorbcijos neveikia.
The absorption is not affected by food.
Absoliutus iš
Absolute oral bioavailability relative to intravenous administration has not been determined.
lyginant su pavartotu į, nenustatytas. veną
The major circulating metabolite is the 1 0-N-glucuronide, which does not pass the blood brain barrier.
Olanzapinas metabolizuojamas kepenyse konjugacijos ir oksidacijos bū Daugiausia cirkuliuoja du. metabolito 10- N- gliukuronido, kuris nepraeina pro hematoencefalinį barjerąVeikiant citochromams.
Cytochromes P450- CYP 1A2 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.
P450- CYP1A2 ir P450- CYP2D6, susidaro N- dezmetilo ir 2- hidroksimetilo metabolitų Tyrimai su. gyvū parodėkad abu metabolitai in vivo veikia ž
The predominant pharmacologic activity is from the parent olanzapine.
farmakologinis poveikis daugiausia priklauso nuo olanzapino.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Sveikų asmenųgalutinis išgerto olanzapino pusinė eliminacijos periodas priklausė amž 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).
Sveikų senyvųpacientų( 65 metųir daugiau), lyginant su jaunesniais, vidutinis pusinė eliminacijos s periodas buvo ilgesnis (atitinkamai 51, 8 val. ir 33, 8 val.), o klirensas maž esnis (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.
Senyvųpacientų farmakokinetikos kintamumas atitinka jaunesniųpacientųribas.
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 pacientams, sergantiems š vyresniems kaip 65 metų
26 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).
32, 4 val.) ir vaistinio preparato klirenso (atitinkamai 21, 2 l/ val. ir 25, 0 l/ val.) skirtumų Masių. pusiausvyros tyrimųmetu nustatyta, kad 57% radioaktyvią medž ž to olanzapino iš šlapimu, daugiausia metabolitų
Such factors possibly contribute to the higher average exposure observed in adolescents.
26 5. 3 Ikiklinikiniųsaugumo tyrimųduomenys
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).
Keliems š unims, gavusiems 8 mg/ kg ar 10
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
negu skiriant 12 mg dozę mogui), nustatyta laikina neutropenija,
27 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.
jųbakterijųmutacijos testais bei in vitro ir in vivo ž Standartiniais mutageninio ar
6.3 Shelf life
27 4 metai.
4 years.
6. 4 Specialios laikymo są lygos
14, 28, 35, 56 or 70 tablets in a box.
ž, Dėutėkurioje yra 14, 28, 35, 56 or 70 tableč OPA/ Al/ PVC ir aliuminio folijos lizdinė plokš mis. telė
Not all pack sizes may be marketed.
Gali bū tiekiamos ne visųdydž pakuotė ti ių s.
6.6 Special precautions for disposal
6. 6 Specialū reikalavimai atliekoms tvarkyti s
Any unused product or waste material should be disposed of in accordance with local requirements.
Nesuvartotąpreparatą atliekas reikia tvarkyti laikantis vietinių
7.
ar
MARKETING AUTHORISATION HOLDER
RINKODAROS TEISĖ TURĖ
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
interneto svetainė http: // www. emea. europa. eu /. je
Zalasta 7.5 mg tablets
Zalasta 7, 5 mg tabletė s
Each tablet contains 7.5 mg olanzapine.
Kiekvienoje tabletė yra 7, 5 mg olanzapino. je
Each tablet contains 121.3 mg lactose.
Kiekvienoje tabletė yra 121, 3 mg laktozė
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 7.5”.
gaubtos, gelsvos, ant jųgali bū pavieniųgeltonų mių ti dė,
30 Olanzapine can be given without regards for meals as absorption is not affected by food.
galima skirti nepriklausomai nuo valgio, kadangi maistas neveikia jo
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
pradinė dozė mg per parąpaprastai nerekomenduojama, (5)
31 with olanzapine compared to patients treated with placebo (1.3% vs.
NCVR daž buvo 3 kartus didesnis nei gavusiems placebą
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
30 Buvo pripaž kad > 75 metų ius ir kraujagyslinė miš demencija gydant olanzapinu yra
32 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.
priežasties yra sumažję vartojantiems neutropeniją sukelianč vaistinius preparatus, pacientams, ius č kuriems anksč yra buvę vaistinių
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical tria ls.
tyrimųmetu kai kuriems senyviems pacientams stebė ortostatinė ta hipotenzija.
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Ilgalaikė pasekmė susijusios su š reiš
33 Lactose Zalasta tablets contain lactose.
kiniais, netirtos ir nežinomos (ž 4. 8 ir 5. 1 skyrius). r.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
s kumas arba gliukozė ir galaktozė malabsorbcija š vaistinio preparato vartoti Lapp laktazė trū negalima.
Interaction studies have only been performed in adults.
32 Są veikos tyrimai atlikti tik suaugusiesiems.
34 4.6 Pregnancy and lactation
Nėtumo laikotarpis.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
nė pakankamai duomenųapie š vaisto poveikįmogaus vaisiui, todėnėč
37 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Palyginamųjųpaauglių suaugusių
38 Management of overdose There is no specific antidote for olanzapine.
Perdozavimo gydymas Specifinio olanzapino priešnuodž nė Nerekomenduojama sukelti vė
39 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.
40 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).
32, 4 val.) ir vaistinio preparato klirenso (atitinkamai 21, 2 l/ val. ir 25, 0 l/ val.) skirtumų Masių. pusiausvyros tyrimųmetu nustatyta, kad 57% radioaktyvią medž ž to olanzapino iš šlapimu, daugiausia metabolitų
Such factors possibly contribute to the higher average exposure observed in adolescents.
39 5. 3 Ikiklinikiniųsaugumo tyrimųduomenys
41 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.
jųbakterijųmutacijos testais bei in vitro ir in vivo ž Standartiniais mutageninio ar
PHARMACEUTICAL PARTICULARS
induoliųtestais,
6.1 List of excipients
Kancerogeniš
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
Įvertinus tyrimų ž mis ir pelė rezultatus, galima teigti, kad olanzapinas nė
6.2 Incompatibilities
su iurkė
Not applicable.
kancerogeniš kas.
6.3 Shelf life
FARMACINĖINFORMACIJA
Zalasta 10 mg tablets
Zalasta 10 mg tabletė s
Each tablet contains 10 mg olanzapine.
Kiekvienoje tabletė yra 10 mg olanzapino. je
Each tablet contains 161.8 mg lactose.
Kiekvienoje tabletė yra 161, 8 mg laktozė
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 10”.
as „ 10 “.
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.
Š izofrenijos, manijos epizodo gydymo ir bipolinio sutrikimo pasikartojimų profilaktikos metu paros dozė bū palaipsniui koreguojama pagal ligonio klinikinę klę nuo 5 mg iki 20 mg per parą
44 Olanzapine can be given without regards for meals as absorption is not affected by food.
Nutraukti gydymą
When more than one factor is present which might result in slower metabolism (femal e gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
Kai yra daugiau nei vienas veiksnys, galintis lė metabolizmą nerūkymas), turi bū sprendž
45 with olanzapine compared to patients treated with placebo (1.3% vs.
NCVR daž buvo 3 kartus didesnis nei gavusiems placebą
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
vartojępacientai, patyręcerebrovaskuliniųreiš, turė rizikos veiksnių kinių jo.
46 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.
priežasties yra sumažję vartojantiems neutropeniją sukelianč vaistinius preparatus, pacientams, ius č kuriems anksč yra buvę vaistinių
47 Lactose Zalasta tablets contain lactose.
kiniais, netirtos ir nežinomos (ž 4. 8 ir 5. 1 skyrius). r.
4.5 Interaction with other medicinal products and other forms of interaction
45 4. 5 Są veika su kitais vaistiniais preparatais ir kitokia sąveika
Interaction studies have only been performed in adults.
Są veikos tyrimai atlikti tik suaugusiesiems.
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
olanzapino dozęPradedant gydyti CYP1A2 inhibitoriumi, reikia apsvarstyti olanzapino dozė sumaž inimą.
48 4.6 Pregnancy and lactation
Nėtumo ir š
Pregnancy:
indymo laikotarpis
There are no adequate and well-controlled studies in pregnant women.
46 Nėtumo laikotarpis.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Nė adekvač ir gerai kontroliuojamųolanzapino poveikio nėč tyrimųŠ
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 vaistą vartojanč moterį
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.
tik tuomet, kai laukiamas nauda pateisins galimą rizikąvaisiui.
Lactation:
imai, kad kū
Dizziness Akathisia6
47 Nervųsistemos sutrikimai Somnolencija Širdies sutrikimai
Seizures where in most cases a history of
Galvos svaigimas Akatizija 6 Parkinsonizmas 6 Diskinezija 6
49
Traukuliai, kurių daugeliu atvejųatsirado 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
Cardiac disorders
Bradikardija QTc pailgė jimas (ž
Parkinsonism6 Dyskinesia 6
Skilvelinė
seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
4. 4 skyrių
Vascular disorders
tachikardija/ skilvelių
Bradycardia QT c prolongation (see section 4.4)
virpėjimas, staigi mirtis (ž 4. 4 skyrių r.)
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Kraujagysliųsutrikimai Virš
High creatine phosphokinase Increased total bilirubin
Bendrieji sutrikimai ir vartojimo vietos paž eidimai Astenija Nuovargis Edema Tyrimai
Increased alkaine phosphatase
Kreatino fosfokinazės
15% of baseline body
koncentracijos
50
jimas8
51 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Palyginamųjųpaauglių suaugusių
52 Management of overdose There is no specific antidote for olanzapine.
Perdozavimo gydymas Specifinio olanzapino priešnuodž nė Nerekomenduojama sukelti vė
53 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.
54 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).
32, 4 val.) ir vaistinio preparato klirenso (atitinkamai 21, 2 l/ val. ir 25, 0 l/ val.) skirtumųMasių. pusiausvyros tyrimųmetu nustatyta, kad 57% radioaktyvią medž ž to olanzapino iš šlapimu, daugiausia metabolitų
Such factors possibly contribute to the higher average exposure observed in adolescents.
52 5. 3 Ikiklinikiniųsaugumo tyrimųduomenys
55 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.
jųbakterijųmutacijos testais bei in vitro ir in vivo ž Standartiniais mutageninio ar
6.3 Shelf life
53 4 metai.
7, 14, 28, 35, 56 or 70 tablets in a box.
ž, Dėutėkurioje yra 7, 14, 28, 35, 56 or 70 tableč OPA/ Al/ PVC ir aliuminio folijos lizdinė plokš mis. telė
Zalasta 15 mg tablets
Zalasta 15 mg tabletė s
Each tablet contains 15 mg olanzapine.
Kiekvienoje tabletė yra 15 mg olanzapino. je
Each tablet contains 242.7 mg lactose.
Kiekvienoje tabletė yra 242, 7 mg laktozė
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 15”.
as „ 15 “.
58 Olanzapine can be given without regards for meals as absorption is not affected by food.
galima skirti nepriklausomai nuo valgio, kadangi maistas neveikia jo
59 with olanzapine compared to patients treated with placebo (1.3% vs.
NCVR daž buvo 3 kartus didesnis nei gavusiems placebą
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
56 Buvo pripaž kad > 75 metų ius ir kraujagyslinė miš demencija gydant olanzapinu yra
60 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.
priežasties yra sumažję vartojantiems neutropeniją sukelianč vaistinius preparatus, pacientams, ius č kuriems anksč yra buvę vaistinių
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
astinio ryš tarp gydymo olanzapinu ir venųtromboembolijos nenustatyta. io
61 Lactose Zalasta tablets contain lactose.
kiniais, netirtos ir nežinomos (ž 4. 8 ir 5. 1 skyrius). r.
Interaction studies have only been performed in adults.
58 Są veikos tyrimai atlikti tik suaugusiesiems.
CNS medicinal products Caution should be exercised in patients who receive medicinal products that can cause central nervous system depression and alcohol.
Bendrasis CNS aktyvumas Reikia atsargiai gydyti pacientus, kurie geria alkoholio arba vartoja vaistiniųpreparatųgalinč slopinti centrinęnervųsistemą
62 4.6 Pregnancy and lactation
Nėtumo laikotarpis.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
parkinsonizmas (ž 4. 4 skyrių diskinezija, ortostatinė
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
hipotenzija, anticholinerginis poveikis,
The frequency terms listed are defined as follows:
trumpalaikis simptomųnesukeliantis kepenų iš rimas, astenija, nuovargis ir edema. bė
Very common (≥
jimas (ž 4. 4 skyrių r.),
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Papildoma informacija apie specialių grupių pacientus Klinikiniai tyrimai, kuriuose dalyvavo demencija sergantys senyvi pacientai, parodė ių mirč ir cerebrovaskuliniųnepageidaujamųreakcijųpadaž jimą
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
vartojimu (ž 4. 4 skyrių Labai daž nepageidaujamos reakcijos, susijusios su olanzapino
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Daž pasireiš
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
jimas, letargija, eritema, regos haliucinacijos ir š pneumonija, kū temperatū padidė nelaikymas.
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.
(dopamino agonistų sukelta)
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
psichozėsusijusi su Parkinsono liga, duomenimis, daž ir daž nei vartojant placebąpasunkė
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
parkinsoniniai simptomai ir atsirado haliucinacijų.
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Vieno klinikinio tyrimo, kuriame dalyvavo pacientai, sergantys bipoline manija, duomenimis, kartu su olanzapinu vartojant valproato, neutropenija pasieiš 4, 1% atvejų Galimas skatinamasis veiksnys gali bū didelė
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
Olanzapiną
In most patients, levels returned to normal ranges without cessation of treatment.
vartojant kartu su lič ar valproatu, iu
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.
daž pasireiš (1 0%) drebulys, burnos dž vimas, apetito ir svorio padidė
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
pat dažnai jimas 7
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Olanzapiną
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
vartojant kartu su lič ar divalproeksu, svorio padidė iu
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.
% pradinio svorio gydymo metu (iki 6 savaič) nustatytas 17, 4% pacientų Ilgalaikis (iki 12 mė)
Olanzapine administered with lithium or valproate resulted in increased levels ( 10%) of tremor, dry mouth, increased appetite, and weight gain.
olanzapino vartojimas atkryč profilaktikai pacientams, kuriems diagnozuotas bipolinis sutrikimas, io jimu 7% pradinio svorio.
Speech disorder was also reported commonly.
39, 9% pacientų buvo susiję su kū svorio padidė
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).
Palyginamųjųpaauglių suaugusių
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of  from baseline body weight in 39.9% of 7% patients.
jų
65 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
gydymo klinikiniųtyrimųneatlikta, visgi palyginti tyrimųkuriuose dalyvavo paaugliai, ir suaugusių tyrimų duomenys.
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.
Toliau esanč lentelė apibendrintos nepageidaujamos reakcijos, kurios daž pasireiš
66 Management of overdose There is no specific antidote for olanzapine.
Perdozavimo gydymas Specifinio olanzapino priešnuodž nė Nerekomenduojama sukelti vė
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta- agonist activity since beta stimulation may worsen hypotension.
funkcijas, gydyti hipotenziją kraujotakos kolapsą už
Cardiovascular monitoring is necessary to detect possible arrhythmias.
bei tikrinti kvė pavimo funkcijąNegalima.
Close medical supervision and monitoring should continue until the patient recovers.
vartoti epinefrino, dopamino ir kitųsimpatomimetikųkuriems bū
5.1 Pharmacodynamic properties
dingas beta agonistinis aktyvumas,
Pharmacotherapeutic group: antipsychotics: diazepines, oxazepines and thiazepines, ATC code:
Reikia nuolat tirti š
N05AH03.
irdies ir
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Pacientą kol iš simptomai. nyks
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
5. 1 Farmakodinaminė savybė
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
N05A H03.
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.
Olanzapinas yra antipsichozinis, slopinantis maniją stabilizuojantis nuotaiką plačiai farmakologiš veikiantis daugelį
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.
Tiriant olanzapino poveikį
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
gyvū nųelgsenai, nustatyta, kad jam
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.
bū dingas 5HT, dopamino ir cholinerginis antagonizmas, atitinkantis jungimosi su receptoriais profilį.
In addition, a 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.
Elektrofiziologiniai tyrimai parodėkad olanzapinas selektyviai maž mezolimbinių
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.
dopaminerginiųneuronų krovą beveik neveikia motorines funkcijas reguliuojanč dryž
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).
vengimo refleksą( testas
In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
antipsichoziniam poveikiui į vertinti), yra maž s negu sukelianč katalepsiją
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.
antipsichoziniai vaistiniai preparatai, olanzapinas padidina atsaką.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition
Sveikiems savanoriams, iš rusiems vienkartinę mg olanzapino dozępozitronų
67 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.
10
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.
,
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).
emisijos
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.
tomografijos (PET) bū buvo nustatyta, kad daugiau olanzapino prisijungė negu prie dopamino D2
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
du receptorių Be to, SPECT tyrimo su š
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
iaisiais metu nustatyta,
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
kad sėkmingai olanzapinu gydomųpacientųdryž
5.2 Pharmacokinetic properties
uotajame kū buvo maž už ne
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
negu sėkmingai kitais antipsichoziniais vaistiniais preparatais bei risperidonu gydomųir panaš kaipiai sėkmingai klozapinu gydomų
The absorption is not affected by food.
pacientų.
Absolute oral bioavailability relative to intravenous administration has not been determined.
Dviejuose iš dviejųplacebo ir
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
dviejuose ištrijųlyginamuosiuose kontroliuojamuose klinikiniuose
The major circulating metabolite is the 1 0-N-glucuronide, which does not pass the blood brain barrier.
tyrimuose dalyvavusiems daugiau nei 2900 š
The predominant pharmacologic activity is from the parent olanzapine.
izofrenija sergantiems pacientams su teigiamais ir
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
neigiamais simptomais olanzapinas statistiš patikimai sumaž ir vienus, ir kitus simptomus.
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).
Tarptautiniame palyginamajame klinikiniame tyrime, atliktame dvigubai aklu bū dalyvavo 1481 du, pacientas, sergantis šizofrenija, šizoafektiniu ar panaš sutrikimu, kuriems buvo į
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
asocijuotų depresijos simptomų
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.
(prieš gydymą
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
vidutinis rodiklis pagal Montgomery- Asberg depresijos
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Prospektyvi antrinė
68 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).
nuotaikos skalė rodikliųprieš s
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).
gydymą galutinių ir
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
tyrimo rezultatųpokyč analizė
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
io
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
parodė statistiš patikimą
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
(p = 0, 001) gydant olanzapinu jimą
1
(- 6) palyginti su haloperidoliu (- 3, 1).
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Pacientams, sergantiems bipoliniu sutrikimu, manijos ar miš epizodo metu olanzapino raus efektyvumas buvo didesnis nei placebo ir valproato (divalproeks) slopinant manijos simptomus 3 savaites.
Such factors possibly contribute to the higher average exposure observed in adolescents.
Olanzapino efektyvumas buvo panaš kaip haloperidolio lyginant pacientųkuriems manijos
5.3 Preclinical safety data
,
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
ir depresijos simptomai sumažjo, dalį 6 ir 12 savaič.
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Klinikinio tyrimo, kai buvo skiriamas litis
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
arba valproatas maž iausiai 2 savaites, papildomai paskyrus 10 mg olanzapino (gydymas kartu su lič iu arba valproatu) manijos simptomų savaites.
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
slopinimas buvo geresnis nei skiriant vien litįarba valproatą6
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.
12 mė nesiųpasikartojimo prevencijos klinikinio tyrimo metu pacientams, kuriems manijos epizodas buvo sė kmingai nuslopintas olanzapinu, buvo atsitiktinai skirtas olanzapinas arba placebas.
Tolerance developed to the CNS depression.
Olanzapinas sukė statistiš patikimą
Growth parameters were decreased at high doses.
pagrindinei vertinamajai baigč
Haematologic toxicity:
- bipolinio iai
Sedation affected mating performance of male rats.
sutrikimo pasikartojimui.
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).
Taip pat olanzapinas buvo statistiš patikimai pranaš užkertant kelią manijos, tiek depresijos pasikartojimui. tiek
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
Antro 12 mė nesiųpasikartojimo prevencijos klinikinio tyrimo metu pacientams, kuriems manijosepizodas buvo sė
69 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.
kmingai nuslopintas olanzapino ir lič deriniu, buvo atsitiktinai skirtas tik io
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Olanzapinas sukė statistiš patikimą
6.
kai
PHARMACEUTICAL PARTICULARS
geresnį
6.1 List of excipients
poveikį pagrindinei
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
vertinamajai baigč - bipolinio sutrikimo pasikartojimui (olanzapinas 30, 0%, litis 38, 3%; p = 0, 055). iai
6.2 Incompatibilities
18 mė nesių klinikinio tyrimo metu pacientams, kuriems manijos arba miš epizodas buvo sė
Not applicable.
rus
6.3 Shelf life
kmingai
2 years.
ių
6.4 Special precautions for storage
preparatų( lič iu
This medicinal product does not require any special storage conditions.
valproatu), ilgalaikis gydymas olanzapinu kartu su lič arba valproatu nebuvo statistiš reikš pranašesnis už
6.5 Nature and contents of container
gydymą lič arba valproatu pavė
Blister pack (OPA/ Al/ PVC, Al-foil):
tik iu
Not all pack sizes may be marketed.
linant bipolinį pasikartojimąapibū, dinamą
6.6 Special precautions for disposal
sindrominiais diagnozė nustatymo kriterijais. s
Any unused product or waste material should be disposed of in accordance with local requirements.
Vaikai ir paaugliai (13- 17 metų gydymo patirtis ribota ir remiasi trumpalaikiais š Paauglių
7.
)
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
izofrenijos (6 savaič) ir ių
MARKETING AUTHORISATION NUMBER(S)
manijos, susijusios su bipoliniu I tipo sutrikimu (3 savaič), kuriuose dalyvavo maž kaip 200
EU/ 1/ 07/ 415/ 022-026
ių
9.
iau
Date of first authorisation:
paauglių gydymo veiksmingumo tyrimais.
27 September 2007.
Buvo vartojamos lanksč olanzapino dozė nuo 2, 5 iki
70 10.
,
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
ios
71 1.
s:
Zalasta 20 mg tablets
20 mg per parąGydant olanzapinu, paaugliai priaugo daug daugiau svorio, palyginti su. suaugusiaisiais.
2.
r.
QUALITATIVE AND QUANTITATIVE COMPOSITION
poveikio palaikymą ra, o duomenys apie ilgalaikį
Each tablet contains 20 mg olanzapine.
nė
Excipient:
saugumą
Each tablet contains 323.5 mg lactose.
riboti (ž 4. 4 ir 4. 8 skyrius). r.
For a full list of excipients, see section 6.1.
5. 2 Farmakokinetinė savybė
Tablet.
s
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 20”.
Absoliutus iš
4.1 Therapeutic indications
sisavinimas,
Adults Olanzapine is indicated for the treatment of schizophrenia.
lyginant su pavartotu į, nenustatytas. veną
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
P450- CYP1A2 ir P450- CYP2D6, susidaro N- dezmetilo ir 2- hidroksimetilo metabolitų Tyrimai su. gyvū parodėkad abu metabolitai in vivo veikia ž
Olanzapine is indicated for the treatment of moderate to severe manic episode.
nais
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).
,
4.2 Posology and method of administration
Todėl
Adults Schizophrenia:
farmakologinis poveikis daugiausia priklauso nuo olanzapino.
The recommended starting dose for olanzapine is 10 mg/ day.
Sveikų asmenųgalutinis išgerto olanzapino pusinė eliminacijos periodas priklausė amž ir lyties.
Manic episode:
iaus
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Sveikų senyvųpacientų( 65 metųir daugiau), lyginant su jaunesniais, vidutinis pusinė eliminacijos s periodas buvo ilgesnis (atitinkamai 51, 8 val. ir 33, 8 val.), o klirensas maž esnis (atitinkamai 17, 5 l/ val. ir 18, 2 l/ val.).
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.
44 pacientams, sergantiems š vyresniems kaip 65 metų
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.
izofrenija, 5- 20 mg vaistinio preparato paros dozė
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.
s
Gradual tapering of the dose should be considered when discontinuing olanzapine.
nebuvo susijusios su išskirtiniu nepageidaujamu poveikiu.
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).
Moterų lyginant su vyrais, vidutinis pusinė eliminacijos periodas buvo š tiek ilgesnis (atitinkamai
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).
iek
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
36, 7 val. ir 32, 3 val.), o klirensas maž esnis (atitinkamai 18, 9 l/ val. ir 27, 3 l/ val.).
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.
Tač olanzapinas iau (5- 20 mg) buvo panaš saugus ir moterims (n = 467), ir vyrams (n = 869). iai
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
funkcijos sutrikimas (kreatinino klirensas < 10 ml/ min), lyginant su
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
sveikaisiais, nustatyta tik neryš vidutinio pusinė eliminacijos periodo (atitinkamai 37, 7 val. ir
Dose escalation, when indicated, should be conservative in such patients.
32, 4 val.) ir vaistinio preparato klirenso (atitinkamai 21, 2 l/ val. ir 25, 0 l/ val.) skirtumų Masių. pusiausvyros tyrimųmetu nustatyta, kad 57% radioaktyvią medž ž to olanzapino iš šlapimu, daugiausia metabolitų
(See sections 4.5 and 5.2.)
pavidalu.
4.3 Contraindications
siskiria su
Hypersensitivity to the active substance or to any of the excipients.
Rū ių kanč pacientųkurių
Patients with known risk for narrow-angle glaucoma.
neryš sutrikusi kepenų kiai
4.4 Special warnings and precautions for use
funkcija, vidutinis pusinė eliminacijos periodas s
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
(39, 3 val.) buvo ilgesnis, o klirensas (18, 0 l/ val.) mažesnis lyginant su sveikais nerū iais kanč asmenimis (atitinkamai 48, 8 val. ir 14, 1 l/ val.).
Patients should be closely monitored during this period.
kanč pacientų
1.5%, respectively).
moterų lyginant su rū iais, ir),
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
vidutinis pusinė eliminacijos periodas kanč s