natgillin/translations-raw huggingface dataset:
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
La pacien ii adul i care au încheiat o perioad de tratament de 9- 12 luni, rata de cre tere a valorilor medii ale glicemiei s- a încetinit dup aproximativ 4- 6 luni.
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see section 4.4).
4. 4).
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Reac iile adverse foarte frecvente asociate cu utilizarea olanzapinei la acest grup de pacien i au fost tulbur rile de mers i c derile.
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Frecvent s- au observat pneumonie, cre terea temperaturii corpului, letargie, eritem, halucina ii vizuale i incon inen urinar.
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.
În studiile clinice la pacien ii cu psihoz indus medicamentos (agonist dopaminergic) asociat cu boala Parkinson, s- au raportat foarte frecvent i mai frecvent decât dup administrarea de placebo agravarea simptomatologiei parkinsoniene i a halucina iilor.
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.
Într- un studiu clinic la pacien i cu manie bipolar, terapia asociat cu valproat i olanzapin a dus la o inciden de 4, 1% a neutropeniei; un factor poten ial care a contribuit la aceasta este concentra ia plasmatic crescut a valproatului.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
Olanzapina administrat cu litiu sau valproat a dus la cre terea frecven ei (> 10%) tremorului, xerostomiei, cre terii apetitului alimentar i cre terii în greutate.
Speech disorder was also reported commonly.
De asemenea, s- au raportat frecvent (1% pân la 10%) tulbur ri de vorbire.
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).
În timpul tratamentului cu olanzapin în asociere cu litiu sau divalproex, în faza tratamentului acut (pân la 6 s pt mâni) la 17, 4% dintre pacien i s- a produs o cre tere de 7% a greut ii corporale fa de valoarea ini ial.
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
Tratamentul îndelungat cu olanzapin (pân la 12 luni) pentru prevenirea recuren elor la pacien ii cu tulburare bipolar s- a asociat la 39, 9% dintre pacien i cu o cre tere de ≥7% a greut ii corporale fa de momentul ini ierii tratamentului.
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Copii i adolescen i Olanzapina nu este indicat pentru tratamentul copiilor i adolescen ilor sub 18 ani.
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.
Chiar dac nu s- au efectuat studii clinice menite s compare adolescen ii cu adul ii, informa iile din studiile clinice la adolescen i au fost comparate cu cele la popula ia adult.
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.
Urm torul tabel sumarizeaz reac iile adverse raportate cu o frecven mai mare la pacien ii adolescen i (vârsta 13- 17 ani) fa de cei adul i sau reac ii adverse identificate doar în cadrul studiilor la pacien i adolescen i.
Clinically significant weight gain (7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Cre terea în greutate semnificativ din punct de vedere clinic pare s apar mai frecvent în rândul adolescen ilor fa de adul ii ce au avut expuneri comparabile.
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.
Amploarea cre terii în greutate i propor ia pacien ilor adolescen i care au avut cre teri în greutate semnificative clinic au
The frequency terms listed are defined as follows:
10 fost mai mari în cazul expunerii îndelungate (cel pu in 24 s pt mâni) decât în cazul expunerilor de scurt durat.
10 Metabolism and nutrition disorders Very common:
Frecven a evenimentelor listate este definit dup cum urmeaz: foarte frecvente (≥10%), frecvente (≥1% i < 10%).
Weight gain9, elevated triglyceride levels10, increased appetite.
Cre tere în greutate9, cre terea concentra iei trigliceridelor10, apetit alimentar crescut.
Elevated cholesterol levels11 Nervous system disorders Very common:
Tulbur ri ale sistemului nervos Foarte frecvente:
Sedation (including: hypersomnia, lethargy, somnolence).
Sedare (incluzând hipersomnie, letargie, sedare, somnolen).
Gastrointestinal disorders Common:
Tulbur ri gastro- intestinale Frecvente:
Dry mouth Hepato-biliary disorders Very common:
Tulbur ri hepatobiliare Foarte frecvente:
Investigations Very common:
Investiga ii diagnostice Foarte frecvente:
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
Sc derea bilirubinei totale, cre terea GGT, niveluri plasmatice crescute ale prolactinei12.
9 Weight gain 7% of baseline body weight (kg) was very common and 15% of baseline body weight was common.
9 Cre terea în greutate 7% fa de masa corporal ini ial a fost foarte frecvent, iar cre terea 15% fa de masa corporal ini ial a fost frecvent.
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.
În cazul expunerii îndelungate (cel pu in 24 s pt mâni), aproximativ jum tate dintre pacien ii adolescen i au avut o cre tere în greutate 15% i aproape o treime o cre tere 25% fa de masa corporal ini ial.
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
În cadrul pacien ilor adolescen i, cre terea medie în greutate a avut cea mai mare valoare în rândul pacien ilor care la momentul ini ial erau supraponderali sau obezi.
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (1.016 mmol/ l - < 1.467 mmol/ l) to high (1.467 mmol/ l).
10 Observat pentru valori ini iale normale à jeun (< 1, 016 mmol/ l) care au atins valori crescute (1, 467 mmol/ l) i modific rile valorilor ini iale ale trigliceridelor à jeun de la valori limit (1, 016 mmol/ l - < 1, 467 mmol/ l) la valori crescute (1, 467 mmol/ l) au fost foarte frecvente.
11 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/ l) to high (5.17 mmol/ l) were observed commonly.
11 Observat frecvent pentru valori ini iale normale à jeun (< 4, 39 mmol/ l) care au atins valori crescute (5, 17 mmol/ l).
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.
Modific rile valorilor ini iale ale colesterolului à jeun de la valori limit (4, 39 mmol/ l - < 5, 17 mmol/ l) la valori crescute (5, 17 mmol/ l) au fost foarte frecvente.
12 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
12 Niveluri plasmatice crescute ale prolactinei au fost raportate la 47, 4% dintre pacien ii adolescen i.
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.
Semne i simptome Simptomele de supradozaj foarte frecvente (inciden a > 10%) includ tahicardie, agita ie/ agresivitate, dizartrie, diferite simptome extrapiramidale i pierderea con tien ei, de la sedare pân la com.
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.
Alte manifest ri semnificative de supradozaj sunt delir, convulsii, com, sindrom neuroleptic malign posibil, deprimare respiratorie, aspira ie traheobron ic, hipertensiune sau hipotensiune arterial, aritmii cardiace (< 2% din cazurile de supradozaj) i stop cardiorespirator.
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.
S- au raportat cazuri letale în urma unor supradoze acute de numai 450 mg, dar s- a raportat i supravie uirea dup o supradoz acut de 1500 mg.
Management of overdose There is no specific antidote for olanzapine.
Tratamentul supradozajului Nu exist un antidot specific pentru olanzapin.
Induction of emesis is not recommended.
Nu se recomand provocarea de v rs turi.
Standard procedures for management of overdose may be indicated (i. e. gastric lavage, administration of activated charcoal).
Pot fi indicate m surile standard pentru tratamentul supradozajului (de exemplu, sp l turi gastrice, administrarea de c rbune activat).
The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
S- a demonstrat c administrarea concomitent a c rbunelui activat reduce biodisponibilitatea oral a olanzapinei cu 50- 60%.
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.
11 Trebuie instituit tratament simptomatic i monitorizarea func iilor vitale în func ie de starea clinic, incluzând tratamentul hipotensiunii arteriale i a colapsului circulator i sus inerea func iei respiratorii.
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta- agonist activity since beta stimulation may worsen hypotension.
A nu se utiliza adrenalin, dopamin sau alte simpatomimetice beta- agoniste, deoarece stimularea beta poate agrava hipotensiunea arterial.
Cardiovascular monitoring is necessary to detect possible arrhythmias.
Este necesar monitorizare cardiovascular, pentru eviden ierea unor posibile aritmii.
Close medical supervision and monitoring should continue until the patient recovers.
Supravegherea i monitorizarea medical strict trebuie continuate pân când pacientul este recuperat din punct de vedere clinic.
Pharmacotherapeutic group: antipsychotic, ATC code:
Grupa farmacoterapeutic: antipsihotic, cod ATC:
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Olanzapina este un antipsihotic, antimaniacal i stabilizator de dispozi ie cu profil farmacologic larg, care include mai multe sisteme de receptori.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/ 2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α 1 adrenergic; and histamine H1 receptors.
În studiile preclinice, olanzapina a demonstrat afinitate fa de unii receptori (Ki < 100 nM) pentru serotonin 5 HT2A/ 2C; 5 HT3, 5 HT6; pentru dopamin D1, D2, D3, D4, D5; pentru receptorii colinergici muscarinici m1- m5; pentru receptorii 1 adrenergici; pentru receptorii histaminergici H1.
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Studiile comportamentale cu olanzapin la animale au eviden iat c aceasta prezint antagonism 5 HT serotoninergic, dopaminergic i colinergic, în concordan cu profilul leg rii de receptori.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Pe modele in vitro olanzapina a demonstrat o afinitate mai mare pentru receptorii serotoninergici 5 HT2 decât pentru cei dopaminergici D2 i, pe modele in vivo, o activitate mai mare pentru receptorii 5 HT2 decât pentru cei D2.
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.
Studiile electrofiziologice au demonstrat c olanzapina reduce selectiv desc rc rile neuronilor dopaminergici mezolimbici (A10), având, în acela i timp, ac iune slab asupra c ilor striatale (A9) implicate în func ia motorie.
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.
Olanzapina a redus r spunsul de evitare condi ionat, test elocvent pentru activitatea antipsihotic, la doze mai mici decât cele care produc catalepsie, efect care indic reac ii adverse motorii.
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
Spre deosebire de anumite alte antipsihotice, olanzapina determin un r spuns crescut într- un test „ anxiolitic ”.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A than dopamine D2 receptor occupancy.
Studii de tomografie cu emisie de pozitroni (TEP) la voluntari s n to i au eviden iat, pentru o doz oral unic (10 mg) de olanzapin, un grad de ocupare a receptorilor 5 HT2A mai mare decât a celor dopaminici D2.
In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
În plus, un studiu de imagistic SPECT la pacien i cu schizofrenie a eviden iat c pacien ii care prezint r spuns la olanzapin au un grad de ocupare a receptorilor D2 striatali mai mic decât cei care prezint r spuns la anumite alte antipsihotice i la risperidon, dar comparabil cu cei care au r spuns la clozapin.
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.
În amândou din cele dou studii controlate cu placebo, precum i în dou din cele trei studii controlate cu un comparator, efectuate la peste 2900 pacien i cu schizofrenie, care au prezentat atât simptome pozitive cât i negative, olanzapina s- a asociat cu amelior ri superioare semnificative statistic, atât pentru simptomele negative, cât i pentru cele pozitive.
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
Într- un studiu comparativ, multina ional, dublu- orb, care a inclus 1481 pacien i cu schizofrenie, tulburare shizoafectiv i tulbur ri asociate având diferite grade de simptome depresive asociate (valoare bazal a scorului de 16, 6 pe Montgomery- Asberg Depression Rating Scale), o analiz secundar prospectiv a modific rii scorului dispozi iei de la momentul ini ierii tratamentului pân la încetarea acestuia a demonstrat c îmbun t irea acestui scor (p=0, 001) este semnificativ statistic în grupul tratat cu olanzapin (- 6, 0) comparativ cu grupul tratat cu haloperidol (- 3, 1).
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.
La pacien ii cu episod maniacal sau mixt în cadrul tulbur rii bipolare, olanzapina a demonstrat eficacitate superioar comparativ cu placebo i comparativ cu valproat semisodic (divalproex) privind reducerea simptomelor maniacale dup 3 s pt mâni.
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.
Olanzapina a demonstrat i eficacitate comparabil cu haloperidolul în ceea ce prive te propor ia pacien ilor cu remisiune simptomatic a maniei i depresiei la 6 i 12 s pt mâni.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
12 valproat) a determinat, dup 6 s pt mâni, o reducere mai mare a simptomelor maniacale decât în cazul monoterapiei cu litiu sau cu valproat.
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.
Într- un studiu de prevenire a recuren elor episoadelor maniacale cu durata de 12 luni la pacien i afla i în remisiune dup tratament cu olanzapin i care au fost apoi randomiza i cu olanzapin sau placebo, olanzapina a demonstrat superioritate semnificativ statistic comparativ cu placebo din punct de vedere al parametrului principal, recuren a tulbur rii bipolare.
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Olanzapina a demonstrat de asemenea avantaj semnificativ statistic comparativ cu placebo în ceea ce prive te prevenirea recuren elor episoadelor maniacale sau depresive.
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).
Într- un al doilea studiu cu durata de 12 luni de prevenire a recuren elor episoadelor maniacale la pacien i afla i în remisie dup tratament cu olanzapin în asociere cu litiu i care au fost apoi randomiza i cu olanzapin sau litiu în monoterapie, olanzapina a prezentat statistic non- inferioritate fa de litiu din punct de vedere al parametrului principal, recuren a tulbur rii bipolare (olanzapin 30, 0%, litiu 38, 3%; p=0, 055).
12 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Într- un studiu de tratament asociat, cu durata de 18 luni, la pacien i cu episoade maniacale sau mixte stabiliza i cu olanzapin i un stabilizator de dispozi ie (litiu sau valproat), asocierea de lung durat dintre olanzapin i litiu sau valproat nu a fost semnificativ statistic superioar monoterapiei cu litiu sau valproat în întârzierea recuren ei tulbur rii bipolare, definit conform criteriilor diagnostice.
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.
Popula ie pediatric Experien a la adolescen i (vârsta între 13 i 17 ani) este limitat la date de eficacitate pe termen scurt în tratamentul schizofreniei (6 s pt mâni) i al maniei ascociate tulbur rii bipolare I (3 s pt mâni), ce au inclus mai pu in de 200 adolescen i.
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
Olanzapina a fost utilizat într- un interval de dozare flexibil începând de la 2, 5 i ajungând pân la 20 mg. zi.
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
În timpul tratamentului cu olanzapin, adolescen ii au crescut semnificativ mai mult în greutate fa de adul i.
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.
Magnitudinea modific rilor nivelurilor colesterolului total à jeun, a colesterolului LDL, trigliceridelor i prolactinei (vezi pct.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
4. 4 i 4. 8).
Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Comprimatul orodispersabil de olanzapin este bioechivalent cu comprimatele filmate de olanzapin având vitez i grad de absorb ie similare.
Olanzapine orodispersible tablets may be used as an alternative to olanzapine coated tablets.
Comprimatele orodispersabile de olanzapin se pot folosi ca alternativ la comprimatele filmate de olanzapin.
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Olanzapina se absoarbe bine dup administrare oral, atingând concentra ia plasmatic maxim dup 5- 8 ore.
The absorption is not affected by food.
Absorb ia nu este influen at de alimente.
Absolute oral bioavailability relative to intravenous administration has not been determined
Biodisponibilitatea oral absolut în compara ie cu administrarea intravenoas nu a fost determinat.
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Olanzapina se metabolizeaz în ficat, prin conjugare i oxidare.
The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Metabolitul circulant principal este 10- N- glucuronidul, care nu traverseaz bariera hemato- encefalic.
Cytochromes P450- CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Enzimele citocromului P450 - CYP1A2 i P450- CYP2D6 contribuie la formarea metaboli ilor N- demetil i 2- hidroximetil care, în studii la animale, au prezentat activitate farmacologic in vivo semnificativ mai mic decât olanzapina.
The predominant pharmacologic activity is from the parent olanzapine.
Responsabil de efectele farmacologice este în principal olanzapina netransformat.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
La voluntari s n to i, dup administrare oral, timpul mediu de înjum t ire plasmatic prin eliminare al olanzapinei a variat în func ie de vârsta i sex.
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).
La vârstnici (65 ani i peste) s n to i comparativ cu subiec ii mai tineri, timpul mediu de înjum t ire plasmatic prin eliminare a fost mai lung (51, 8 ore comparativ cu 33, 8 ore), iar clearance- ul a fost mai mic (17, 5 l/ or comparativ cu 18, 2 l/ or).