qanastek/EMEA-V3 huggingface dataset:
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).
4. 2 skyri).
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Pradedant gydyti CYP1A2, reikia apsvarstyti olanzapino doz s sumažinim.
20 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), vienkartin antacidini vaist (aliuminio, magnio) ar cimetidino doz reikšmingai olanzapino farmakokinetikos nekei ia.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Galimas olanzapino poveikis kitiems vaistams Olanzapinas gali slopinti tiesiogini ir netiesiogini dopamino agonist poveik.
1A2, 2D6, 2C9, 2C19, 3A4).
20 In vitro olanzapinas neslopina pagrindini CYP450 izoferment (pvz., 1A2, 2D6, 2C9, 2C19, 3A4), tod l specifin s s veikos nesitikima.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Bendrasis CNS aktyvumas Reikia atsargiai gydyti pacientus, kurie geria alkoholio arba vartoja vaistini preparat, galin i slopinti centrin nerv sistem.
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Dar n ra pakankamai duomen apie šio vaisto poveik žmogaus vaisiui, tod l n š iosioms jo galima skirti tik tuomet, kai laukiama nauda pateisins galim rizik vaisiui.
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Klinikiniuose tyrimuose su sveikomis k dik žindan iomismoterimis buvo nustatyta, kad olanzapino patenka moters pien.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg) Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Pacient ms reikia patarti, kad, vartodamos olanzapin, k dikio nežindyt.
21 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
4. 4 skyri), diskinezija, ortostatin hipotenzija, anticholinerginis poveikis, trumpalaikis simptom nesukeliantis tkepen transaminazi aktyvumo padid jimas (žr.
The frequency terms listed are defined as follows:
Išvardytas sutrikim dažnis apib dinamas taip: labai dažni (10%), dažni (nuo 1% iki < 10%), nedažni (nuo 0, 1% iki < 1%), reti (nuo
Very common (10%), common (1% and < 10%), uncommon (0.1% and < 1%), rare (0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
21 0, 01% iki < 0, 1%), labai reti (< 0, 01%), dažnis nežinomas (negali b ti vertintas pagal turimus duomenis).
22 Hepato-biliary disorders
22 Kepen, tulžies p sl s ir latak sutrikimai
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.
Nesant išsamios informacijos apie jau buvusius minius ar v lyvuosius ekstrapiramidinius
23 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
23 jud jimo sutrikimus, šiuo metu negalima teigti, kad olanzapinas re iau sukelia v lyv j diskinezij ir (ar) kitus v lyvuosius ekstrapiramidinius sindromus.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’ s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Klinikini tyrim, kuriuose dalyvavo pacientai, kuriems pasireišk vaist (dopamino agonist) sukelta psichoz, susijusi su Parkinsono liga, duomenimis, dažnai ir dažniau nei vartojant placeb, pasunk jo parkinsoniniai simptomai ir atsirado haliucinacij.
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
Galimas skatinamasis veiksnys gali b ti didel valproato koncentracija plazmoje.
Speech disorder was also reported commonly.
Taip pat dažnai steb tas kalbos sutrikimas.
Clinically significant weight gain (7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Paaugliams kliniškai reikšmingai (7%) k no svorios padid jimas dažniau, negu suaugusiems žmon ms, kuri organizme ekspozicija buvo panaši.
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Ilgalaik s (mažiausiai 24 savai i) ekspozicijos metu paaugliu k no svorio padid jimo dydis ir paaugli, kuri k no svoris padid jo kliniškai reikšmingai, dalis buvo didesni, negu trumpalaik s ekspozicijos metu
24 Metabolism and nutrition disorders Very common:
24 Metabolizmo ir mitybos sutrikimai Labai dažni.
Weight gain9, elevated triglyceride levels10, increased appetite.
Svorio padid jimas 9, triglicerid koncentracijos padid jimas 10, apetito padid jimas.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Tyrimais nustatyta, kad in vitro olanzapino afinitetas didesnis serotonino 5 HT2 negu dopamino D2 receptoriams, in vivo ryškesnis poveikis serotonino 5 HT2 negu dopamino D2 receptoriams.
Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Olanzapino efektyvumas buvo panašus kaip haloperidolio lyginant manijos ir depresijos simptom sumaž jimo santyk per 6 ir 12savai i.
26 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.
26 18 m nesi klinikinio tyrimo metu pacientams, kuriems manijos arba mišrus epizodas buvo s kmingai nuslopintas skiriant olanzapin kartu su vienu iš nuotaik stabilizuojan i vaist (li iu arba valproatu), ilgalaikis gydymas olanzapinu kartu su li iu arba valproatu nebuvo statistiškai reikšmingai pranašesnis už gydym tik li iu arba valproatu pav linant bipolin pasikartojim, apib dinam sindrominiais diagnoz s nustatymo kriterijais.
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).
R kan i pacient, kuri neryškiai sutrikusi kepen funkcija, vidutinis pusin s eliminacijos periodas (39, 3 val.) buvo ilgesnis, o klirensas (18, 0 l/ val.) mažesnis lyginant su sveikais ner kan iais asmenimis (atitinkamai 48, 8 val. ir 14, 1 l/ val.).
However, the magnitude of the impact of age, gender, or
Ner kan i pacient (vyr ir moter), lyginant su r kan iais, vidutinis pusin s eliminacijos periodas buvo ilgesnis (atitinkamai 38, 6 val. ir 30, 4 val.), o klirensas mažesnis (atitinkamai 18, 6 l/ val. ir 27, 7 l/ val.).
27 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
27 Olanzapino klirensas yra mažesnis senyv pacient lyginant su jaunesniais, moter lyginant su vyrais, ir ner kan i j lyginant su r kan iaisiais.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
minis (vienkartin s doz s) toksiškumas Graužikams geriamojo vaisto sukeltas toksiškumas buvo toks pat kaip sukeltas stipri neuroleptik: sumaž j s aktyvumas, koma, drebulys, kloniniai traukuliai, seil tekis ir nepriaug s svoris.
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
1, 1 mg/ kg doz (3 kartus didesn už didžiausi žmogaus doz) veik žiurki estrogeninius ciklus, 3 mg/ kg doz (9 kartus didesn už didžiausi žmogaus doz) - reprodukcij.
Aluminium blister strips in cartons of 28, 35 56, or 70 orodispersible tablets per carton.
Kartono d žut, kurioje yra 28, 35, 56 arba 70 burnoje disperguojam j table i, supakuot aliuminio lizdines plokšteles.
ZYPREXA VELOTAB 15 mg orodispersible tablets
ZYPREXA VELOTAB 15 mg burnoje disperguojamosios tablet s
Each orodispersible tablet contains 15 mg olanzapine.
Vienoje burnoje disperguojamoje tablet je yra 15 mg olanzapino.
Each orodispersible tablet contains 1.20 mg aspartame, 0.225 mg sodium methyl parahydroxybenzoate, 0.075 mg sodium propyl parahydroxybenzoate.
1, 2 mg aspartamo 0, 225 mg metilo parahidroksibenzoato natrio druskos 0, 075 mg propilo parahidroksibenzoato natrio druskos.
The recommended starting dose is 10 mg/ day.
Rekomenduojama pradin olanzapino doz – 10 mg per par.
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Pacientams, kuri manijos epizodas yra gydomas olanzapinu, bipolinio sutrikimo pasikartojimo prevencijos gydym t sti tomis pa iomis doz mis.
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.
Jei naujas manijos, mišrus arba depresijos epizodas ištinka, gydym olanzapinu reikia t sti (jei reikia optimizuoti doz) kartu pagal klinikines indikacijas papildomai skiriant nuotaikos simptom gydym.
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.
Olanzapin skiriant šizofrenijos, manijos epizodo gydymui ir bipolinio sutrikimo pasikartojimo prevencijai paros doz gali b ti palaipsniui koreguojama pagal ligonio klinikin b kl ir gali b ti nuo 5 mg iki 20 mg per par.
An increase to a dose greater than the recommended starting dose is advised only after
Didinti doz iki didesn s nei rekomenduojama pradin patariama tik kruopš iai kartotinai vertinus klinikin ligonio b kl ir ne trumpesniais nei 24 valand intervalais.
Olanzapine can be given without regards for meals as absorption is not affected by food.
30 Olanzapin galima skirti nepriklausomai nuo valgio, kadangi maistas neveikia jo absorbcijos.
Gradual tapering of the dose should be considered when discontinuing olanzapine.
Nutraukti gydym olanzapinu reik t palaipsniui mažinant doz.
Elderly patients 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 section 4.4).
4. 4 skyri).
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.
Kai yra vidutinio laipsnio kepen nepakankamumas (ciroz, A ar B Child- Pugh klas), reikia skirti 5 mg pradin doz, kuri galima didinti atsargiai.
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Lytis Moterims pradin doz ir dozi diapazonas netur t b ti kei iami rutiniškai.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
R kymas Ner kantiems pacientams pradin doz ir dozi diapazonas netur t b ti kei iami rutiniškai.
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
Kai yra daugiau kaip vienas veiksnys, galintis l tinti metabolizm (moteriškoji lytis, senyvas amžius, ner kantysis), pradin doz turi b ti mažesn.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Antipsichoziniais vaistais gydom pacient klinikin b kl pager ja po keli dien ar savai i.
31 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Placebo kontroliuojam klinikini tyrim metu (6- 12 savai i trukm s) su
1.5%, respectively).
31 senyvais (vidutinis amžius 78 metai) sergan iais demencija ir (arba) elgesio sutrikim turin iais pacientais, gydyt olanzapinu pacient mir i dažnis buvo 2 kartus didesnis nei gavusi placeb (atitinkamai 3, 5%, palyginti su 1, 5%).
Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e. g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Šios populiacijos grup s pacient mirtingumo dažnio padid jim gydant olanzapinu gali lemti tokie rizikos veiksniai kaip amžius > 65 met, disfagija, sedacija, mitybos sutrikimai ir dehidratacija, plau i ligos (t. y. pneumonija su aspiracija arba be jos), arba kartu vartojami benzodiazepinai.
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Tuose pa iuose klinikiniuose tyrimuose buvo nepageidaujam cerebrovaskulini reiškini (NCVR t. y. insultas, praeinantysis išemijos priepuolis), skaitant mirties atvejus.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Visi olanzapin ir placeb vartoj pacientai, patyr cerebrovaskulini reiškini, prieš tyrim tur jo rizikos veiksni.
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Piktybinis neurolepsinis sindromas (PNS) PNS tai gyvybei pavojingas b kl, kuri sukelia antipsichoziniai vaistiniai preparatai.
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
Hiperglikemija ir diabetas Labai retai ZYPREXA VELOTAB gydomiems pacientams pasteb ta hiperglikemija ir/ arba cukrinio diabeto išsivystymas arba pasunk jusi eiga, retkar iais su ketoacidoze ar koma; pasitaik keletas mirties atvej (žr.
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Kai kuriems iš j prieš tai padid jo k no svoris, kuris gal jo b ti predisponuojantis veiksnys.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
Lipid poky iai Kontrolini (poveikis lygintas su placebo) tyrim metu olanzapinu gydomiems pacientams atsirado nepageidaujamas lipid pokytis (žr.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Lipid pokyt reikia reguliuoti klinikai tinkamu b du, ypatingai pacientams kuriems yra dislipidemija ir pacientams turintiems lipid sutrikim rizikos veiksni.
32 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Anticholinerginis poveikis Olanzapinas in vitro veikia anticholinergiškai, ta iau klinikini tyrim patirtis rodo, kad ši reiškini b na retai.
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.
Dar mažai yra klinikin s patirties olanzapinu gydant ligonius, sergan ius ir kitomis ligomis, tod l j atsargiai skirti tiems asmenims, kuriems yra prostatos hipertrofija, paralyžinis žarn nepraeinamumas ar panaši b kl.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
32 Kepen funkcija Dažnai, ypa gydymo pradžioje, laikinai, nesukeldama simptom, padid ja kepen transaminazi (ALAT, ASAT) koncentracija.
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.
Atsargiai vaist skirti pacientams, kuriems esti padid jusi ALAT ir (ar) ASAT koncentracija, yra kepen funkcijos sutrikimo simptom, b kl, susijusi su ribotu kepen funkcijos rezervu, taip pat gydomiems hepatotoksiškais vaistais.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
Jeigu, gydant šiuo vaistu, nustatoma padid jusi ALAT ir (ar) ASAT koncentracija, tyrim kartoti po tam tikro laiko ir prireikus mažinti doz.
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.
Neutropenija Olanzapino atsargiai skiriama pacientams, kuri leukocit ir (ar) neutrofil skai ius d l bet kokios priežasties yra sumaž j s, vartojantiems neutropenij sukelian ius vaistus, pacientams, kuriems anks iau yra buv s vaist sukeltas kaul iulp slopinimas (toksiškumas) arba kaul iulp slopinim yra suk lusi kita liga, spindulinis gydymas ar chemoterapija, taip pat tiems asmenims, kuriems yra hipereozinofilin b kl ar mieloproliferacin liga.
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
QT intervalas Klinikini tyrim metu kliniškai reikšmingas QTc intervalo pailg jimas (Fridericia QT korekcija [QTcF] 500 milisekundži [msek] bet kuriuo metu po bazinio dydžio nustatymo pacientams, kuri bazinis QTcF < 500 msek) olanzapinu gydytiems pacientams buvo nedažnas (nuo 0, 1% iki 1%), palyginti su placebu joki reikšming su tuo susijusi nepageidaujam širdies reiškini skirtum nebuvo.
33 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
V lyvoji diskinezija Vieneri met ir trumpesni lyginamieji tyrimai parod, kad olanzapinas statistiškai patikimai re iau sukelia diskinezij.
However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
V lyvosios diskinezijos rizika did ja gydant ilgai, tod l, atsiradus jos požymi, reikia spr sti, ar mažinti vaisto doz ar jo nebevartoti.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
33 Ortostatin hipotenzija Olanzapino klinikini tyrim metu kai kuriems senyviems pacientams steb ta ortostatin hipotenzija.
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 met paaugliams Olanzapino 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.
Tyrimai, kuriuose dalyvavo 13- 17 met pacientai, parod vairias nepageidaujamas reakcijas, skaitant svorio padid jim, medžiag apykaitos paky ius ir prolaktino koncentracijos padid jim.
4.5 Interaction with other medicaments and other forms of interaction
4. 5 S veika su kitais vaistiniais preparatais ir kitokia s veika
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Pradedant gydyti CYP1A2 reikia apsvarstyti olanzapino doz s sumažinim.
34 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), vienkartin antacidini vaist (aliuminio, magnio) ar cimetidino doz reikšmingai olanzapino farmakokinetikos nekei ia.
1A2, 2D6, 2C9, 2C19, 3A4).
34 In vitro olanzapinas neslopina pagrindini CYP450 izoferment (pvz., 1A2, 2D6, 2C9, 2C19, 3A4), tod l specifin s s veikos nesitikima.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Bendrasis CNS aktyvumas Reikia atsargiai gydyti pacientus, kurie geria alkoholio arba vartoja vaistini preparat, galin i slopinti centrin nerv sistem
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Esant pastoviajai vaisto koncentracijai plazmoje, vidutin k dikio ekspozicija (mg/ kg) yra 1, 8% motinos olanzapino doz s (mg/ kg).
35 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
4. 4 skyri), diskinezija, ortostatin hipotenzija, anticholinerginis poveikis, trumpalaikis simptom nesukeliantis tkepen transaminazi aktyvumo padid jimas (žr.
Very common (10%), common (1% and < 10%), uncommon (0.1% and < 1%), rare (0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
35 0, 01% iki < 0, 1%), labai reti (< 0, 01%), dažnis nežinomas (negali b ti vertintas pagal turimus duomenis).
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
4. 4 skyri)
Orthostatic hypotension
Kraujagysli sutrikimai
Gastrointestinal disorders
Ortostatin hipotenzija
Mild, transient anticholinergic effects including constipation and dry mouth
Tromboembolija (skaitant plau i embolij ir gili j ven tromboz)
36 Hepato-biliary disorders
36 Virškinimo trakto sutrikimai
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Lengvas, trumpalaikis anticholinerginis poveikis, skaitant viduri užkiet jim ir burnos dži vim
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Pankreatitas
Skin and subcutaneous tissue disorders
Kepen, tulžies p sl s ir latak sutrikimai
Rash
4. 4 skyri)
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
37 6 Klinikini tyrim metu parkinsonizmo ir distonijos dažnis olanzapinu gydytiems pacientams buvo didesnis, ta iau statistiškai reikšmingai nesiskyr nuo vartojusi j placeb.
In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it can not be concluded at present that olanzapine produces less tardive dyskinesia and/ or other tardive extrapyramidal syndromes.
Be detalios informacijos apie jau buvusius minius ar v lyvuosius ekstrapiramidinius jud jimo sutrikimus, negalima teigti, kad olanzapinas re iau sukelia v lyv j diskinezij ir (ar) kitus v lyvuosius ekstrapiramidinius sindromus.
37 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 Staigiai nutraukus olanzapino vartojim, atsirado mini simptom, pavyzdžiui: prakaitavimas, nemiga, drebulys, nerimas, pykinimas ir v mimas.
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Labai dažnos nepageidaujamos reakcijos, susijusios su olanzapino vartojimu, šios grup s pacientams buvo nenormali eisena ir pargriuvimai.
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Dažnai pasireišk pneumonija, k no temperat ros padid jimas, letargija, paraudimas, regos haliucinacijos ir šlapimo nelaikymas.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’ s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Klinikini tyrim, kuriuose dalyvavo pacientai, kuriems pasireišk vaistini preparat (dopamino agonist) sukelta psichoz, susijusi su Parkinsono liga, duomenimis, dažnai ir dažniau nei vartojant placeb, pasunk jo parkinsoniniai simptomai ir atsirado haliucinacij.
Clinically significant weight gain (7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Paaugliams kliniškai reikšmingai (7%) k no svoris padid jo dažniau, negu suaugusiems žmon ms, kuri organizme ekspozicija buvo panaši.
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Ilgalaik s (mažiausiai 24 savai i) ekspozicijos metu paaugli k no svorio padid jimo dydis ir paaugli, kuri k no svoris padid jo kliniškai reikšmingai, dalis buvo didesni, negu trumpalaik s ekspozicijos metu
38 Metabolism and nutrition disorders Very common:
38 Metabolizmo ir mitybos sutrikimai Labai dažni.
Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Olanzapino efektyvumas buvo panašus kaip haloperidolio lyginant manijos ir depresijos simptom sumaž jimo santyk per 6 ir 12 m nesi.
40 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.
40 18 m nesi klinikinio tyrimo metu pacientams, kuriems manijos arba mišrus epizodas buvo s kmingai nuslopintas skiriant olanzapin kartu su vienu iš nuotaik stabilizuojan i vaist (li iu arba valproatu), ilgalaikis gydymas olanzapinu kartu su li iu arba valproatu nebuvo statistiškai reikšmingai pranašesnis už gydym tik li iu arba valproatu pav linant bipolin pasikartojim, apib dinam sindrominiais diagnoz s nustatymo kriterijais.
41 The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
41 Olanzapino klirensas yra mažesnis senyv pacient lyginant su jaunesniais, moter lyginant su vyrais, ir ner kan i j lyginant su r kan iaisiais.
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.
Ta iau amžiaus, lyties ir r kymo taka olanzapino klirensui ir pusin s eliminacijos periodui yra nedidel lyginant su bendraisiais individ tarpusavio skirtumais.
Not all pack sizes may be marketed.
Gali b ti tiekiamos ne vis dydži pakuot s
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten Nyderlandai
ZYPREXA VELOTAB 20 mg orodispersible tablets
ZYPREXA VELOTAB 20 mg burnoje disperguojamosios tablet s.
Each orodispersible tablet contains 20 mg olanzapine.
Vienoje burnoje disperguojamoje tablet je yra 20 mg olanzapino.
Each orodispersible tablet contains 1.60 mg aspartame, 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
1, 6 mg aspartamo 0, 3 mg metilo parahidroksibenzoato natrio druskos 0, 1 mg propilo parahidroksibenzoato natrio druskos.
44 appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
44 vertinus klinikin ligonio b kl ir paprastai turi b ti atliekamas ne trumpesniais kaip 24 valand intervalais.
45 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
45 Su demencija susijusios psichoz s ir (arba) elgesio sutrikimai Olanzapinas n ra patvirtintas su demencija susijusi psichozi ir (arba) elgesio sutrikim gydymui bei yra nerekomenduojamas b tent šios grup s pacientams, nes padid ja mirtingumas ir cerebrovaskulini sutrikim rizika.
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
T pa i klinikini tyrim metu buvo nepageidaujam cerebrovaskulini reiškini (NCVR t. y. insultas, praeinantys išemijos priepuoliai), skaitant mirties atvejus.
46 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Kadangi dar yra mažai klinikin s patirties olanzapinu gydant ligonius, sergan ius ir kitomis
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.
46 ligomis, tod l j reikia atsargiai skirti tiems asmenims, kuriems yra prostatos hipertrofija, paralyžinis žarn nepraeinamumas ar panaši b kl.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Ta iau olanzapin, kaip ir visus antipsichozinius vaistinius preparatus, reikia atsargiai skirti kartu su vaistais,, ilginan iais QTc interval, ypa senyviems pacientams, taip pat asmenims, kuriems yra gimtas ilgo QT sindromas, stazinis širdies nepakankamumas, širdies hipertrofija, hipokalemija ar hipomagnezemija.
47 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
V lyvoji diskinezija Vieneri met ir trumpesni lyginamieji tyrimai parod, kad olanzapinas statistiškai patikimai re iau sukelia diskinezij.
However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
V lyvosios diskinezijos rizika did ja gydant ilgai, tod l, atsiradus jos požymiams, reikia spr sti, ar mažinti vaisto doz ar jo nebevartoti.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
47 Ortostatin hipotenzija Olanzapino klinikini tyrim metu kai kuriems senyviems pacientams steb ta ortostatin hipotenzija.
48 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), vienkartin antacidini vaist (aliuminio, magnio) ar cimetidino doz reikšmingai olanzapino farmakokinetikos nekei ia.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
48 Galimas olanzapino poveikis kitiems vaistams Olanzapinas gali slopinti tiesiogini ir netiesiogini dopamino agonist poveik.
49 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
4. 4 skyri), diskinezija, ortostatin hipotenzija, anticholinerginis poveikis, trumpalaikis simptom nesukeliantis tkepen transaminazi aktyvumo padid jimas (žr.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
49 Toliau esan ioje lentel je išvardytos nepageidaujamos reakcijos ir laboratorini tyrim duomenys, gauti iš pavieni pranešim ir klinikini tyrim.
Gastrointestinal disorders
50 Virškinimo trakto sutrikimai
50 Hepato-biliary disorders
Kepen, tulžies p sl s ir latak sutrikimai
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
51 6 Klinikini tyrim metu parkinsonizmo ir distonijos dažnis olanzapinu gydytiems pacientams buvo didesnis, ta iau statistiškai reikšmingai nesiskyr nuo vartojusi j placeb.
51 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 Staigiai nutraukus olanzapino vartojim, atsirado mini simptom, pavyzdžiui: prakaitavimas, nemiga, drebulys, nerimas, pykinimas ir v mimas.
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short- term clinical trials in adolescent patients.
Toliau esan ioje lentel je apibendrintos nepageidaujamos reakcijos, kurios dažniau pasireišk paaugliams (13- 17 met) nei suaugusiesiems ar nepageidaujamos reakcijos, kurios nustatytos tik trumpalaki klinikini tyrim, kuriuose dalyvavo paaugliai, metu.
52 Metabolism and nutrition disorders Very common:
52 Metabolizmo ir mitybos sutrikimai Labai dažni.
54 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.
54 18 m nesi klinikinio tyrimo metu pacientams, kuriems manijos arba mišrus epizodas buvo s kmingai nuslopintas skiriant olanzapin kartu su vienu iš nuotaik stabilizuojan i vaist (li iu arba valproatu), ilgalaikis gydymas olanzapinu kartu su li iu arba valproatu nebuvo statistiškai reikšmingai pranašesnis už gydym tik li iu arba valproatu pav linant bipolin pasikartojim, apib dinam sindrominiais diagnoz s nustatymo kriterijais.
55 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
55 Olanzapino klirensas yra mažesnis senyv pacient lyginant su jaunesniais, moter lyginant su vyrais, ir ner kan i j lyginant su r kan iaisiais.
Reproductive toxicity Olanzapine had no teratogenic effects.
Olanzapinas neveik teratogeniškai.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
vertinus tyrim su žiurk mis ir pel mis rezultatus, galima teigti, kad olanzapinas n ra kancerogeniškas.
57 ANNEX II
57 II PRIEDAS
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
GAMYBOS LICENCIJOS TUR TOJAS, ATSAKINGAS UŽ SERIJ IŠLEIDIM
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
GAMYBOS LICENCIJOS TUR TOJAS (- AI), ATSAKINGAS (- I) UŽ SERIJ IŠLEIDIM
Name and address of the manufacturers responsible for batch release in the EEA
Gamintojo (-), atsakingo (-) už serij išleidim, pavadinimas (- ai) ir adresas (- ai)
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Ispanija
The Marketing Authorisation Holder will provide the PSUR annually.
Rinkodaros teis s tur tojas pateiks periodiškai atnaujinam saugumo protokol kart per metus.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Rizikos valdymo planas Rinkodaros teis s tur tojas sipareigoja atlikti tyrimus ir užtikrinti papildomas farmakologinio budrumo priemones, išvardytas farmakologinio budrumo plane, kuris atitinka registracijos liudijimo paraiškos 1. 8. 2 modulio rizikos valdymo plano 1. 3 versij ir v liau Žmon ms skirt vaist komiteto patvirtintus atnaujintus rizikos valdymo planus.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Remiantis Žmon ms skirt vaist komiteto vaistini preparat žmon ms rizikos sumažinimo rekomendacijomis, atnaujint rizikos sumažinimo plan reikia pateikti kartu su periodine saugumo atnaujinimo ataskaita.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Be to, atnaujint rizikos sumažinimo plan reikia pateikti: • gavus nauj duomen, kurie gali tur ti takos esamam saugumo apib dinimui, farmakologinio budrumo planui arba rizikos mažinimo priemon ms; • per 60 dien, kai nustatomos svarbios (farmakologinio budrumo ar rizikos sumažinimo) gair s; • pareikalavus Europos vaist agent rai (EMEA).
59 ANNEX III
59 III PRIEDAS
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
61 INFORMACIJA ANT IŠORIN S PAKUOT S
CARTON OF ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 5 mg BURNOJE DISPERGUOJAM J TABLE I KARTONO D ŽUT
ZYPREXA VELOTAB 5 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 5 mg burnoje disperguojamosios tablet s Olanzapinas
Each orodispersible tablet contains 5 mg olanzapine
Vienoje burnoje disperguojamojoje tablet je yra 5 mg olanzapino.
Other ingredients: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
Pagalbin s medžiagos: želatina, manitolis (E421), aspartamas (E951), metilo parahidroksibenzoato natrio druska (E219), propilo parahidroksibenzoato natrio druska (E217).
28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
28 burnoje disperguojamosios tablet s 35 burnoje disperguojamosios tablet s 56 burnoje disperguojamosios tablet s 70 burnoje disperguojam j table i
METHOD AND ROUTE(S) OF ADMINISTRATION
VARTOJIMO METODAS IR B DAS (- AI)
Read the package leaflet before use
Prieš vartojim perskaitykite pakuot s lapel
Oral use
Vartoti per burn
Separate one blister cell from the strip.
Atpl šti vien lizdel nuo lizdin s plokštel s.
Carefully peel off the backing.
Atsargiai nupl šti folij.
Gently push the tablet out.
Atsargiai išspausti tablet.
Put the tablet in your mouth
Tablet d ti burn.
MARKETING AUTHORISATION NUMBER (S)
RINKODAROS PAŽYM JIMO NUMERIS
EU/ 1/ 99/ 125/ 001 28 orodispersible tablets EU/ 1/ 99/ 125/ 009 35 orodispersible tablets EU/ 1/ 99/ 125/ 005 56 orodispersible tablets EU/ 1/ 99/ 125/ 013 70 orodispersible tablets
EU/ 1/ 99/ 125/ 001 28 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 009 35 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 005 56 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 013 70 burnoje disperguojam j table i
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
63 MINIMALI INFORMACIJA ANT LIZDINI PLOKŠTELI ARBA DVISLUOKSNI JUOSTELI
BLISTER FOIL LABEL
ZYPREXA VELOTAB 5 mg BURNOJE DISPERGUOJAM J TABLE I FOLIJOS ETIKET
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
64 INFORMACIJA ANT IŠORIN S PAKUOT S
CARTON OF ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 10 mg BURNOJE DISPERGUOJAM J TABLE I KARTONO D ŽUT
ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 10 mg burnoje disperguojamosios tablet s Olanzapinas
Each orodispersible tablet contains 10 mg olanzapine
Vienoje burnoje disperguojamojoje tablet je yra 10 mg olanzapino.
Read the package leaflet before use
Prieš vartojim perskaitykite pakuot s lapel.
EU/ 1/ 99/ 125/ 002 28 orodispersible tablets EU/ 1/ 99/ 125/ 010 35 orodispersible tablets EU/ 1/ 99/ 125/ 006 56 orodispersible tablets EU/ 1/ 99/ 125/ 014 70 orodispersible tablets
EU/ 1/ 99/ 125/ 002 28 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 010 35 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 006 56 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 014 70 burnoje disperguojam j table i
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
66 MINIMALI INFORMACIJA ANT LIZDINI PLOKŠTELI ARBA DVISLUOKSNI JUOSTELI
BLISTER FOIL LABEL
ZYPREXA VELOTAB 10 mg BURNOJE DISPERGUOJAM J TABLE I LIZDIN S PLOKŠTEL S FOLIJOS ETIKET
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
67 INFORMACIJA ANT IŠORIN S PAKUOT S
CARTON OF ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 15 mg BURNOJE DISPERGUOJAM J TABLE I KARTONO D ŽUT
ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 15 mg burnoje disperguojamosios tablet s Olanzapinas
Each tablet contains 15 mg olanzapine
Vienoje burnoje disperguojamojoje tablet je yra 15 mg olanzapino.
EU/ 1/ 99/ 125/ 003 28 orodispersible tablets EU/ 1/ 99/ 125/ 011 35 orodispersible tablets EU/ 1/ 99/ 125/ 007 56 orodispersible tablets EU/ 1/ 99/ 125/ 015 70 orodispersible tablets
EU/ 1/ 99/ 125/ 003 28 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 011 35 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 007 56 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 015 70 burnoje disperguojam j table i
69 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
69 MINIMALI INFORMACIJA ANT LIZDINI PLOKŠTELI ARBA DVISLUOKSNI JUOSTELI
BLISTER FOIL LABEL
ZYPREXA VELOTAB 15 mg BURNOJE DISPERGUOJAM J TABLE I LIZDINI PLOKŠTELI FOLIJOS ETIKET
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
70 INFORMACIJA ANT IŠORIN S PAKUOT S
CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
ZYPREXA VELOTAB 20 mg BURNOJE DISPERGUOJAM J TABLE I KARTONO D ŽUT
ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
ZYPREXA VELOTAB 20 mg burnoje disperguojamosios tablet s Olanzapinas
Each orodispersible tablet contains 20 mg olanzapine
Vienoje burnoje disperguojamojoje tablet je yra 20 mg olanzapino.
Store in the original package in order to protect from light and moisture
Laikyti gamintojo pakuot je, kad preparatas b t apsaugotas nuo šviesos ir dr gm s.
EU/ 1/ 99/ 125/ 004 28 orodispersible tablets EU/ 1/ 99/ 125/ 012 35 orodispersible tablets EU/ 1/ 99/ 125/ 008 56 orodispersible tablets EU/ 1/ 99/ 125/ 016 70 orodispersible tablets
EU/ 1/ 99/ 125/ 004 28 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 012 35 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 008 56 burnoje disperguojamosios tablet s EU/ 1/ 99/ 125/ 016 70 burnoje disperguojam j table i
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
72 MINIMALI INFORMACIJA ANT LIZDINI PLOKŠTELI ARBA DVISLUOKSNI JUOSTELI
BLISTER FOIL LABEL
ZYPREXA VELOTAB 20 mg BURNOJE DISPERGUOJAM J TABLE I FOLIJOS ETIKET
ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets olanzapine
ZYPREXA VELOTAB 5 mg burnoje disperguojamosios tablet s ZYPREXA VELOTAB 10 mg burnoje disperguojamosios tablet s ZYPREXA VELOTAB 15 mg burnoje disperguojamosios tablet s ZYPREXA VELOTAB 20 mg burnoje disperguojamosios tablet s Olanzapinas
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Atidžiai perskaitykite vis š lapel, prieš prad dami vartoti vaist.
You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you.
- Jeigu kilt daugiau klausim, kreipkit s gydytoj arba vaistinink.
Do not pass it on to others.
(net tiems, kuri ligos simptomai yra tokie patys kaip J s).
In this leaflet:
poveik, pasakykite gydytojui arba vaistininkui.
What ZYPREXA VELOTAB is and what it is used for 2.
Kas yra ZYPREXA VELOTAB ir kam jis vartojamas 2.
Before you take ZYPREXA VELOTAB 3.
Kas žinotina prieš vartojant ZYPREXA VELOTAB 3.
How to take ZYPREXA VELOTAB 4.
Kaip vartoti ZYPREXA VELOTAB 4.
How to store ZYPREXA VELOTAB 6.
Kaip laikyti ZYPREXA VELOTAB 6.
WHAT ZYPREXA VELOTAB IS AND WHAT IT IS USED FOR
KAS YRA ZYPREXA VELOTAB IR KAM JIS VARTOJAMAS
ZYPREXA VELOTAB belongs to a group of medicines called antipsychotics.
ZYPREXA VELOTAB priklauso vaist nuo psichoz s grupei.
ZYPREXA VELOTAB is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
ZYPREXA VELOTAB gydoma liga, kuriai b dingas nesan i gars gird jimas, nesan i daikt, matymas ar jautimas, klaidingi sitikinimai, ne prastas tarumas ir nepritapimas.
People with this disease may also feel depressed, anxious or tense.
Žmon s, sergantys šia liga, gali jaustis prisl gti, apimti nerimo ar sitemp.
ZYPREXA VELOTAB is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
ZYPREXA VELOTAB gydomos b kl s, kurioms b dingi šie simptomai: pakilumo jausmas, energijos perteklius, žymiai sumaž j s miego poreikis, labai greitas kalb jimo b das bei min i antpl dis,, kartais didelis irzlumas.
It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.
Be to, šis vaistas stabilizuoja nuotaik, tod l saugo nuo su liga susijusio tolesnio, luošinan io jos pakilimo arba prisl gimo (depresijos) iki aukš iausio laipsnio.
BEFORE YOU TAKE ZYPREXA VELOTAB
ZYPREXA VELOTAB vartoti negalima
Do not take ZYPREXA VELOTAB • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA VELOTAB.
- Jeigu yra alergija (padid j s jautrumas) olanzapinui arba bet kuriai pagalbinei ZYPREXA
An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Alergin reakcija gali pasireikšti b rimu, niež jimu, veido, l p tinimu, dusuliu.
If this has happened to you, tell your doctor. • If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
- Jeigu anks iau buvo diagnozuota aki liga, pavyzdžiui, kurio nors tipo glaukoma (akisp džio
Take special care with ZYPREXA VELOTAB • Medicines of this type may cause unusual movements mainly of the face or tongue.
Speciali atsargumo priemoni vartojant ZYPREXA VELOTAB reikia • Šios r šies vaistai gali sukelti ne prastus judesius, ypa veido ir liežuvio.
If this happens after you have been given ZYPREXA VELOTAB tell your doctor. • Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Jei taip atsitiko Jums vartojant ZYPREXA VELOTAB, kreipkit s gydytoj. • Labai retai šios grup s vaistai gali sukelti s karš iavim su padažn jusiu kv pavimu, prakaitavimu, raumen s stingiu ir apsn dimu ar mieguistumu.
If this happens, contact your doctor at once.
Jei taip atsitiko Jums, nedelsdami kreipkit s gydytoj. • ZYPREXA VELOTAB vartoti senyviems demencija sergantiems pacientams nerekomenduojama, nes tai gali sukelti sunk šalutin poveik.
75 • The use of ZYPREXA VELOTAB in elderly patients with dementia is not recommended as it may have serious side effects.
75 Prieš prad dami vartoti ZYPREXA VELOTAB, kiek galima grei iau pasakykite gydytojui, jei sergate šiomis ligomis: