qanastek/EMEA-V3 huggingface dataset:
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
tarp gydymo olanzapinu ir venųtromboembolijos nenustatyta. io
However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e. g. immobilisation of patients, should be identified and preventive measures undertaken.
veiksniųreikia nustatyti visus galimus venųtromboembolijos rizikos veiksnius (pvz., pacientų, imobilizacija) ir imtis profilaktinių priemonių.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Bendrasis CNS aktyvumas Olanzapinas tiesiogiai veikia CNS, todėypačl
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
In vitro jis veikia antagonistiš dopaminui, todėgali slopinti tiesioginiųir netiesioginių dopamino agonistų
Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Olanzapiną atsargiai skirti asmenims, kuriems yra buvętraukuliųarba yra traukuliųslenkstį inti maž galinč veiksniųOlanzapinu gydomiems pacientams traukuliųbū retai, daž
Seizures have been reported to occur rarely in patients when treated with olanzapine.
traukuliųyra buvę anksč arba yra traukuliųrizikos veiksnių
In most of these cases, a history of seizures or risk factors for seizures was reported.
Vieneriųmetų trumpesni lyginamieji tyrimai parodėkad olanzapinas statistiš patikimai reč
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
sukelia diskinezijąVė. lyvosios diskinezijos rizika didė gydant ilgai, todė atsiradus jos pož
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.
Š simptomai gali laikinai pablogė ar net ir
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
atsirasti nutraukus.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
tyrimųmetu kai kuriems senyviems pacientams stebė ortostatinė ta hipotenzija.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
Todėvyresniems kaip 65 metųpacientams, kaip ir vartojantiems bet kokius antipsichozinius l vaistinius preparatus, rekomenduojama periodiš matuoti kraujospū.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
Vartojimas vaikams ir jaunesniems kaip 18 metųpaaugliams Olanzapinas nevartojamas vaikams ir paaugliams gydyti.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Ilgalaikė pasekmė susijusios
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
kiniais, netirtos ir než inomos (ž 4. 8 ir 5. 1 skyrius). r.
5 Lactose Zalasta tablets contain lactose.
4. 5 Są
4.5 Interaction with other medicinal products and other forms of interaction
veika su kitais vaistiniais preparatais ir kitokia sąveika
Interaction studies have only been performed in adults.
5 Są veikos tyrimai atlikti tik suaugusiesiems.
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.
Galimas kitųvaistųpoveikis olanzapinu iagos, kurios specifiš indukuoja ar slopina š į Olanzapiną metabolizuoja CYP1A2, todėmedž
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
CYP1A2 indukcija Olanzapino metabolizmą greitinti rū
Only slight to moderate increase in olanzapine clearance has been observed.
koncentracijąOlanzapino klirensas padidė nedaug ar vidutiniš Dėto klinikinių
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).
paprastai nebū tač rekomenduojama stebė paciento bū ir prireikus apsvarstyti, ar nepadidinti
Inhibition of CYP1A2 Fluvoxamine, a specific CYP 1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
CYP1A2 slopinimas Nustatyta, kad fluvoksaminas, specifinis CYP1A2 inhibitorius, reikšmingai slopina olanzapino metabolizmąFluvoksaminą padidė 54%, o
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Olanzapino plotas po koncentracijos- laiko
The mean increase in olanzapine AUC was 52% and 108% respectively.
kreive (AUC) vidutiniš padidė atitinkamai 52% ir 108%.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
bet kurį CYP1A2 inhibitorių pvz., ciprofloksacinąbū apsvarstyti, ar neskirti maž pradinę
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
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.
l reikia skirti 2 valandas prieš arba po olanzapino vartojimo.
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), vienkartinė antacidinių ar cimetidino dozė reikš
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Galimas olanzapino poveikis kitiems vaistiniams preparatams Olanzapinas gali slopinti tiesioginiųir netiesioginiųdopamino agonistųpoveikį.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
In vitro olanzapinas neslopina pagrindiniųCYP450 izofermentų
1A2, 2D6, 2C9, 2C19, 3A4).
(pvz., 1A2, 2D6, 2C9, 2C19, 3A4),
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
(CYP2C9), teofilino (CYP1A2) ar diazepamo (CYP3A4 ir 2C19) – metabolizmo slopinimo.
Olanzapine showed no interaction when co-administered with lithium or biperiden.
vartojant kartu su lič ar biperidenu. iu
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
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Bendrasis CNS aktyvumas Reikia atsargiai gydyti pacientus, kurie geria alkoholio arba vartoja vaistiniųpreparatųgalinč slopinti centrinęnervųsistemą
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).
Olanzapiną vartoti kartu su vaistiniais preparatais nuo parkinsonizmo pacientams, kurie serga Parkinsono liga ir demencija, nerekomenduojama (ž 4. 4 skyrių
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Olanzapiną skirti kartu su vaistiniais preparatais, ilginanč QTc intervalą reikia atsargiai (ž 4. 4 skyrių).
6 4.6 Pregnancy and lactation
4. 6
Pregnancy:
šiajai
There are no adequate and well-controlled studies in pregnant women.
reikia į ti, kad ji praneš savo gydytojui, jei pastojo ar ketina pastoti.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
6 nė pakankamai duomenųapie š vaisto poveikįmogaus vaisiui, todėnėč
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
tik tuomet, kai laukiamas nauda pateisins galimąrizikąvaisiui.
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.
š Buvo gauti labai reti pavieniai pranešimai, kad kū dikiams, kuriuos pagimdė
Lactation:
mėnesius olanzapiną
In a study in lactating, healthy women, olanzapine was excreted in breast milk.
vartojusios moterys, atsirado tremoras, hipertonija, letargija ir mieguistumas.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Klinikiniuose tyrimuose su sveikomis kū ž dikįindanč iomis moterimis buvo nustatyta, kad olanzapino patenka įmotinos pienąKai vaisto koncentracija plazmoje pastovi, vidutinė. kūdikio ekspozicija (mg/ kg) yra 1, 8% motinos olanzapino dozė (mg/ kg).
Patients should be advised not to breast feed an infant if they are taking olanzapine.
Pacientė reikia patarti, kad, vartodamos olanzapinąkū, dikio než indytų.
No studies on the effects on the ability to drive and use machines have been performed.
Poveikis gebė jimui vairuoti ir valdyti mechanizmus netirtas.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Olanzapinas gali sukelti mieguistumąir galvos svaigimątodėjį vairuodami.
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, 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
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
trumpalaikis simptomųnesukeliantis kepenų iš rimas, astenija, nuovargis ir edema. bė
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
tyrimųKiekvienoje daž grupė nepageidaujamos. nio je
The frequency terms listed are defined as follows:
Iš
Very common (≥
dinamas taip:
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
labai daž (≥%), daž (nuo ≥1% iki < 10%), nedaž (nuo ≥0, 1% iki < 1%), reti (nuo
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
≥0, 01% iki < 0, 1%), labai reti (< 0, 01%), daž než inomas (negali bū į duomenis).
Very common
Labai daž ni
Common
Daž ni
Uncommon
Nedaž ni
Not known
Daž než nis inomas
Blood and the lymphatic system disorders Immune system disorders
Kraujo ir limfinė sistemos sutrikimai s
Thrombocytopenia Allergic reaction
Cholesterolio koncentracijos jimas 2, 3
Metabolism and nutrition
Diabeto atsiradimas arba pasunkė jimas,
disorders
padidė Gliukozė s
Weight gain1
kartais pasireiškiantis ketoacidoze ar koma, į
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
koncentracijos jimas 4
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
padidė Trigliceridų koncentracijos jimas 2, 5 padidė Gliukozurija Apetito padidė jimas
Nervous system disorders Somnolence
Hipotermija
Dizziness Akathisia6
Galvos svaigimas
Seizures where in most cases a history of
Traukuliai, kurių
Cardiac disorders
Akatizija 6
seizures or risk factors 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
Vascular disorders
4. 4 skyrių
Bradycardia QT c prolongation (see section 4.4)
Kraujagysliųsutrikimai
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
virpėjimas, staigi mirtis (ž 4. 4 skyrių r.)
Orthostatic hypotension
Ortostatinėhipotenzija
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Tromboembolija (įskaitant plauč ių emboliją gilių ir jųvenų trombozę)
Gastrointestinal disorders
kinimo trakto sutrikimai
Mild, transient anticholinergic effects including constipation and dry mouth
Lengvas, trumpalaikis anticholinerginis poveikis, įskaitant vidurių kietė ir už jimą burnos dž vimą iū
Hepato-biliary disorders
Hepatitas (į skaitant
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
4. 4 skyrių)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
kepenųpaž eidimą)
Skin and subcutaneous tissue disorders
Odos ir poodinio audinio sutrikimai Iš rimas
Rash
bė
Photosensitivity reaction Alopecia
Padidė jusio jautrumo šviesai reakcija Alopecija
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
Metabolizmo ir mitybos sutrikimai Rabdomiolizė Inkstųir š lapimo takųsutrikimai Sunkumas radė ti šlapintis Lytinė sistemos ir krū sutrikimai
High creatine phosphokinase Increased total bilirubin
Bendrieji sutrikimai ir vartojimo vietos paž eidimai Astenija Nuovargis Edema Tyrimai Š Prolaktino
Increased alkaine phosphatase
Kreatino fosfokinazė s
Clinically significant weight gain was observed
arminė fosfatazė s s
across all baseline Body Mass
koncentracijos
Index (BMI)
suaktyvė jimas
categories.
suaktyvėjimas
15% of baseline body
jimas8
weight was common.
plazmoje padidė 1
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
tiriamiesiems. 7 kū svorio padidė jimas buvo labai daž  daž Ilgalaikė
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
ekspozicijos metu 25pacientų no svorio padidė 2
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
Normali pradinė koncentracija nevalgius (5, 17 mmol/ l), kuri padidė iki didelė (6, 2 mmol/ l).
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Normali pradinėkoncentracija nevalgius (< 5, 56 mmol/ l), kuri padidė iki didelė( ≥7 mmol/ l).
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
Ribinėpradinėgliukozėkoncentracijos nevalgius (≥5, 56- 7 mmol/ l) padidė
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.
Ribinėpradinėtrigliceridų
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 Klinikinių tyrimųmetu parkinsonizmo ir distonijos daž olanzapinu gydytiems pacientams buvo nis mingai nesiskyr ė vartojusių placebąOlanzapiną didesnis, tač statistiš reikš
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
haloperidolio dozę pasireiš parkinsonizmas, akatizija ir kė
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.
judė sutrikimus, š metu negalima teigti, kad olanzapinas reč sukelia vė ją (ar)
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Staigiai nutraukus olanzapino vartojimąatsirado ū 7
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
nemiga, drebulys, nerimas, pykinimas ir 8
In most patients, levels returned to normal ranges without cessation of treatment.
Susijęklinikiniai simptomai (pvz., ginekomastija, galaktorė krū padidė
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.
iausiai 48 savaič) ekspozicija ių Pacientų kuriems atsirado nepageidaujamas kliniš reikš
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
Suaugusiems pacientams, baigusiems 9 – 12 mė nesių gydymąvidutinis gliukozė kiekis kraujyje padidė greitis maž
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).
vartojimu (ž 4. 4 skyrių Labai daž nepageidaujamos reakcijos, susijusios su olanzapino
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Daž pasireiš
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
jimas, letargija, eritema, regos haliucinacijos ir š pneumonija, kū temperatū padidė nelaikymas.
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.
psichozėsusijusi su Parkinsono liga, duomenimis, daž ir daž nei vartojant placebąpasunkė
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
Vieno klinikinio tyrimo, kuriame dalyvavo pacientai, sergantys bipoline manija, duomenimis, kartu su olanzapinu vartojant valproato, neutropenija pasieiš 4, 1% atvejų Galimas skatinamasis veiksnys
Olanzapine administered with lithium or valproate resulted in increased levels ( 10%) of tremor, dry mouth, increased appetite, and weight gain.
daž pasireiš (1 0%) drebulys, burnos dž vimas, apetito ir svorio padidė
Speech disorder was also reported commonly.
Olanzapiną
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).
% pradinio svorio gydymo metu (iki 6 savaič) nustatytas 17, 4% pacientų Ilgalaikis (iki 12 mė)
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.
39, 9% pacientų buvo susiję su kū svorio padidė
9 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Palyginamųjųpaauglių suaugusių
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.
gydymo klinikiniųtyrimųneatlikta, visgi palyginti tyrimųkuriuose dalyvavo paaugliai, ir suaugusių tyrimų duomenys.
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
Kliniš reikš
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
padidė jimas (≥7%) paaugliams buvo daž
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
iausiai 24 savaič) ekspozicijos metu paaugliųkū svorio padidė ių no
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
mingai, dalis buvo didesni, negu trumpalaikė
Very common (≥ 10%), common (≥ 1% and < 10%).
dinamas taip: labai daž (≥10%), daž (nuo ≥1% iki < 10%).
Metabolism and nutrition disorders Very common:
vardytas sutrikimų nis apibū
Weight gain9, elevated triglyceride levels10, increased appetite.
Metabolizmo ir mitybos sutrikimai jimas 9, trigliceridųkoncentracijos padidė jimas 10, apetito padidė Labai daž Svorio padidė
Elevated cholesterol levels Nervous system disorders Very common:
Nervų sistemos sutrikimai Labai daž Sedacija (į
Sedation (including: hypersomnia, lethargy, somnolence).
skaitant pernelyg didelį mieguistumąletargijąsomnolenciją,,
Gastrointestinal disorders Common:
Virškinimo trakto sutrikimai Daž Burnos dž vimas.
Dry mouth Hepato-biliary disorders Very common:
Kepenų tulž pū s ir latakųsutrikimai
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
Labai daž Kepenųtransmaminazių( ALT/ AST) suaktyvė Tyrimai
Investigations Very common:
jimas (ž 4. 4 skyrių r.
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
Labai daž Bendrojo bilirubino koncentracijos sumažjimas, GGT padaugė
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
15
With long-term exposure (at least 24 weeks), approximately half of adolescent patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
iausiai 24 savaič) ekspozicijos metu maž ių
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
Vidutinis kū svorio svoris, palyginti su baziniu, padidė ≥15%, apie treč
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
prieaugis buvo didž iausias paaugliams, kurie, priešpradedant gydyti, turė antsvorį 10
11 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/ l) to high (≥ 5.17 mmol/ l) were observed commonly.
(1, 467 mmol/ l), o ribinė pradinė trigliceridųkoncentracijos nevalgius (1, 016-  didelė (1, 467 mmol/ l). s 11
Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/ l) to high (≥ 5.17 mmol/ l) were very common.
nevalgius (5, 17- 6, 2 mmol/ l) padidėjimas iki didelė( 6, 2 mmol/ l) buvo labai daž 12
12 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
jimas nustatytas 47, 4% paauglių.
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.
10 itacija/ agresyvumas, dizartrija, į s Perdozavus labai daž (> 10%) bū tachikardija, až
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
piktybinis neurolepsinis sindromas, kvė pavimo slopinimas, aspiracija, hipertenzija ar hipotenzija, širdies aritmijos (< 2% perdozavimo atvejų ir š atvejų kai buvo iš
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.
karto suvartota tik 450 mg, tač pacientas, iš
10 Management of overdose There is no specific antidote for olanzapine.
Perdozavimo gydymas Specifinio olanzapino priešnuodž nė Nerekomenduojama sukelti vė
Induction of emesis is not recommended.
mimąReikia taikyti.
Standard procedures for management of overdose may be indicated (i. e. gastric lavage, administration of activated charcoal).
, skirti aktyvintos anglies).
The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
Kartu vartojama aktyvinta anglis 50- 60% sumaž iš
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.
vartoti epinefrino, dopamino ir kitųsimpatomimetikųkuriems bū
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta- agonist activity since beta stimulation may worsen hypotension.
Reikia nuolat tirti š
Cardiovascular monitoring is necessary to detect possible arrhythmias.
kraujagyslių sistemos bū, kad bū nustatytos galimos aritmijos.
Close medical supervision and monitoring should continue until the patient recovers.
Pacientą kol iš simptomai. nyks
Pharmacotherapeutic group: antipsychotics: diazepines, oxazepines and thiazepines, ATC code:
ATC kodas:
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Olanzapinas yra antipsichozinis, slopinantis maniją stabilizuojantis nuotaiką plačiai farmakologiš veikiantis daugelį
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α adrenergic; and histamine H1 receptors.
Tiriant olanzapino poveikį
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
bū dingas 5HT, dopamino ir cholinerginis antagonizmas, atitinkantis jungimosi su receptoriais profilį.
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 - ryš kesnis poveikis serotonino 5HT2 negu dopamino D2 receptoriams.
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.
antipsichoziniam poveikiui į vertinti), yra maž s negu sukelianč katalepsiją
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.
antipsichoziniai vaistiniai preparatai, olanzapinas padidina atsaką.
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
Sveikiems savanoriams, iš rusiems vienkartinę mg olanzapino dozępozitronų
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.
10
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.
tomografijos (PET) bū buvo nustatyta, kad daugiau olanzapino prisijungė negu prie dopamino D2
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.
neigiamais simptomais olanzapinas statistiš patikimai sumaž ir vienus, ir kitus simptomus.
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).
11 Tarptautiniame palyginamajame klinikiniame tyrime, atliktame dvigubai aklu bū dalyvavo 1481 du, pacientas, sergantis šizofrenija, šizoafektiniu ar panaš sutrikimu, kuriems buvo į
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.
Pacientams, sergantiems bipoliniu sutrikimu, manijos ar miš epizodo metu olanzapino raus efektyvumas buvo didesnis nei placebo ir valproato (divalproeks) slopinant manijos simptomus 3 savaites.
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.
ir depresijos simptomai sumažjo, dalį 6 ir 12 savaič.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition
Klinikinio tyrimo, kai buvo skiriamas litis
11 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.
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
Olanzapinas sukė statistiš patikimą
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recur rence into mania or recurrence into depression.
Taip pat olanzapinas buvo statistiš patikimai pranaš užkertant kelią manijos, tiek depresijos pasikartojimui. tiek
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).
vertinamajai baigč - bipolinio sutrikimo pasikartojimui (olanzapinas 30, 0%, litis 38, 3%; p = 0, 055). iai
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.
valproatu), ilgalaikis gydymas olanzapinu kartu su lič arba valproatu nebuvo statistiš reikš pranašesnis už
Paediatric population The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
manijos, susijusios su bipoliniu I tipo sutrikimu (3 savaič), kuriuose dalyvavo maž kaip 200
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
20 mg per parąGydant olanzapinu, paaugliai priaugo daug daugiau svorio, palyginti su. suaugusiaisiais.
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Duomenų
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.
poveikio palaikymą ra, o duomenys apie ilgalaikį
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
riboti (ž 4. 4 ir 4. 8 skyrius). r.
5.2 Pharmacokinetic properties
5. 2 Farmakokinetinė savybė
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Absoliutus iš
The absorption is not affected by food.
barjerąVeikiant citochromams.
Absolute oral bioavailability relative to intravenous administration has not been determined.
P450- CYP1A2 ir P450- CYP2D6, susidaro N- dezmetilo ir 2- hidroksimetilo metabolitų Tyrimai su. gyvū parodėkad abu metabolitai in vivo veikia ž
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
farmakologinis poveikis daugiausia priklauso nuo olanzapino.
The major circulating metabolite is the 1 0-N-glucuronide, which does not pass the blood brain barrier.
Sveikų olanzapino pusinė eliminacijos periodas priklausė amž ir lyties. s nuo iaus
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.
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 predominant pharmacologic activity is from the parent olanzapine.
44
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
12 pacientams, sergantiems š vyresniems kaip 65 metų nebuvo susijusios su iš
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).
izofrenija, 5- 20 mg vaistinio preparato paros dozė s
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
skirtiniu nepageidaujamu poveikiu.
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.
Moterų lyginant su vyrais, vidutinis pusinė eliminacijos periodas buvo š tiek ilgesnis (atitinkamai
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).
36, 7 val. ir 32, 3 val.), o klirensas maž esnis (atitinkamai 18, 9 l/ val. ir 27, 3 l/ val.).
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Tač olanzapinas iau (5- 20 mg) buvo panaš saugus ir moterims (n = 467), ir vyrams (n = 869). iai
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).
funkcijos sutrikimas (kreatinino klirensas < 10 ml/ min), lyginant su
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
sveikaisiais, nustatyta tik neryš vidutinio pusinė eliminacijos periodo (atitinkamai 37, 7 val. ir
12 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
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).
(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.).
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
buvo ilgesnis (atitinkamai 38, 6 val. ir 30, 4 val.), o klirensas mažesnis (atitinkamai 18, 6 l/ val. ir 27, 7 l/ val.).
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Tač amž
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Tiriant trijųpopuliacijų baltų, japonų kinų - farmakokinetikos rodiklius, skirtumų
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
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.
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
Vaikai ir paaugliai Paaugliai (13- 17 metų Olanzapino farmakokinetika paauglių suaugusių
1
ir
The pharmacokinetics of olanzapine are similar between adolescents and adults.
jųorganizme panaši.
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Kinikinių tyrimų duomenimis, vidutinėolanzapino ekspozicija paaugliųorganizme maždaug 27% jųskirtumai yra š vidutinis paaugliųkū svoris yra didesnėDemografiniai paaugliųir suaugusių
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Š veiksniai gali skatinti ekspozicijos padidė paauglių maž organizme.
Such factors possibly contribute to the higher average exposure observed in adolescents.
5. 3 Ikiklinikiniųsaugumo tyrimųduomenys
5.3 Preclinical safety data
Ū minis (vienkartinė dozė toksiš
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Grauž ikams geriamojo vaisto sukeltas toksiš kumas buvo toks pat kaip sukeltas stipriųneuroleptikų: ės sumažję aktyvumas, koma, drebulys, kloniniai traukuliai, seilė tekis ir nepriaugęsvoris.
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Š mirtina dozė
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
nuo vienkartinė dozė iki 100 mg/ kg.
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Jiems buvo š klinikinių kinių sedacija, ataksija, drebulys, padaž ję š
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
100 mg/ kg dozė
Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
CNS slopinimas, anticholinerginis poveikis ir periferinio kraujo pokyč ie iai.
Tolerance developed to the CNS depression.
CNS slopinimui pasireiš tolerancija.
Growth parameters were decreased at high doses.
Ž
Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
morfologiš pakito makš ir pieno liaukos epitelis.
Haematologic toxicity:
nams pakito kraujo rodikliai.
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
iurkė tač citotoksinio vaisto poveikio kaulųč ms, iau
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 šunims, gavusiems 8 mg/ kg ar 10
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Š, kurių
Reproductive toxicity Olanzapine had no teratogenic effects.
ir proliferuojanč lą s buvo nepakitusios. ios stelė
Sedation affected mating performance of male rats.
iurkiųpatinų poravimuisi.
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
už iausią mogaus dozę - reprodukcijąŽ ž 3 mg/ kg dozė kartus didesnė didž
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
ė olanzapino, palikuoniųfetalinė raida sulė jo, jų
13 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
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
tyrimais, iš klastogeninio olanzapino poveikio nenustatyta.
6.
ra
PHARMACEUTICAL PARTICULARS
kancerogeniš kas.
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
Laktozė monohidratas s Celiuliozė milteliai s Pregelifikuotas kukurū krakmolas zų Kukurū krakmolas zų Koloidinis silicio dioksidas, bevandenis Magnio stearatas
This medicinal product does not require any special storage conditions.
Š vaistiniam preparatui specialių iam laikymo są lygųnereikia.
6.5 Nature and contents of container
6. 5 Pakuotė jos turinys ir
Blister pack (OPA/ Al/ PVC, Al-foil):
ž, Dėutėkurioje yra 14, 28, 35, 56 or 70 tableč OPA/ Al/ PVC ir aliuminio folijos lizdinė plokš mis. telė
14, 28, 35, 56 or 70 tablets in a box.
14
Date of first authorisation:
Rinkodaros teisė suteikimo data:
27 September 2007.
2007 09 27. s
14 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 5 mg tablets
Zalasta 5 mg tabletė s
Each tablet contains 5 mg olanzapine.
Kiekvienoje tabletė yra 5 mg olanzapino. je
Each tablet contains 80.9 mg lactose.
Kiekvienoje tabletė yra 80, 9 mg laktozė
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 5”.
as „ 5 “.
16 Olanzapine can be given without regards for meals as absorption is not affected by food.
16
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.
Olanzapino nerekomenduojama vartoti vaikams ir jaunesniems kaip 18 metųpaaugliams, nes duomenų
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Antipsichoziniais vaistais gydomųpacientų klinikinė klė pagerė tik po keliųdienų savaič.
17 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.
17 Buvo pripaž kad > 75 metų ius ir kraujagyslinė miš demencija gydant olanzapinu yra
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
kontroliuoti, ypatingai tiems pacientams, kuriems yra dislipidemija ir turintiems lipidųsutrikimų rizikos veiksnių.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Anticholinerginis poveikis Olanzapinas in vitro veikia anticholinergiš tač klinikiniųtyrimųpatirtis rodo, kad š reiš
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.
Kadangi dar yra maž klinikinė patirties olanzapinu gydant ligonius, serganč ir kitomis
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
ligomis, todėjį l reikia atsargiai skirti tiems asmenims, kuriems yra prostatos hipertrofija, paralyž inis ž arnųnepraeinamumas ar panašbū. i klė
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.
Jeigu, gydant š vaistu, nustatomas padidė s ALAT ir (ar) ASAT aktyvumas, reikia tyrimą
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
maž dozęDiagnozavus hepatitą skaitant hepatoceliuliarinęcholestazinę miš kepenų
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
Neutropenija Olanzapino atsargiai skiriama pacientams, kuriųleukocitų (ar) neutrofilų
18 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
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
preparatųsukeltas kaulų iulpųslopinimas (toksiš kumas) arba
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Tyrimų kuriuose dalyvavo 13- 17 metų, pacientai, metu pasireiš įkėvairios nepageidaujamos reakcijos, į skaitant svorio padidė, medž
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
kiniais, netirtos ir nežinomos (ž 4. 8 ir 5. 1 skyrius). r.
19 Lactose Zalasta tablets contain lactose.
19 Są veikos tyrimai atlikti tik suaugusiesiems.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Galimas kitųvaistųpoveikis olanzapinu iagos, kurios specifiš indukuoja ar slopina š į Olanzapiną metabolizuoja CYP1A2, todėmedž
4.5 Interaction with other medicinal products and other forms of interaction
izofermentągali veikti olanzapino farmakokinetiką
Interaction studies have only been performed in adults.
CYP1A2 indukcija Olanzapino metabolizmą greitinti rū
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.
gali