natgillin/translations-raw huggingface dataset:
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
prescrierea medicamentului la pacienţ cu hipertrofie de prostatăileus paralitic şafecţ înrudite.
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.
Este necesară
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
În caz de valori crescute ale ALAT ş
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
În cazurile în care s- a diagnosticat o hepatită (incluzând forme prin afectare hepatocelularăprin, colestază prin mecanism mixt), tratamentul cu olanzapină
4 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.
4. 8).
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Întreruperea tratamentului La întreruperea bruscă tratamentului cu olanzapinăau fost raportate foarte rar (< 0, 01%) simptome
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when olanzapine is stopped abruptly.
La întreruperea
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.
≥ milisecunde [msec] în orice moment post- evaluare iniţ la pacienţ cu valori iniţ ale 500 QTcF < 500 msec) a fost mai puţ frecventă
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.
când olanzapina se prescrie în asociere cu medicamente cunoscute ca prelungind intervalul QTc, în ă special la pacienţ vârstnici, la pacienţ cu sindrom QT prelungit congenital, cu insuficienţcardiacă
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
Nu s- a stabilit o relaţ cauzală
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
cu olanzapinăCu toate acestea, deoarece pacienţ cu schizofrenie prezintă
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.
Activitatea generală asupra SNC Ca urmare a efectelor olanzapinei în primul rând asupra sistemului nervos central (SNC), este necesară
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.
prudenţatunci când aceasta se administrează asociere cu alte medicamente cu acţ centrală i
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Deoarece prezintă antagonism dopaminergic in vitro, olanzapina poate să ioneze acţ antagonist faţde efectele agoniş dopaminergici direcţşindirecţ
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.
Olanzapina trebuie utilizată prudenţla pacienţ cu antecedente convulsive sau la cei expuşunor
Seizures have been reported to occur rarely in patients when treated with olanzapine.
La pacienţ trataţ olanzapină raportat rareori
In most of these cases, a history of seizures or risk factors for seizures was reported.
Cu toate acestea, riscul de diskinezie tardivă
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
creş odată expunerea pe termen lung ş în consecinţ dacă un pacient tratat cu olanzapină ă
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.
semne sau simptome de diskinezie tardivătrebuie luată considerare reducerea dozei sau
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Simptomele se pot accentua în timp sau apar chiar după tratamentului.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
În studiile clinice cu olanzapină pacienţ vârstnici s- a observat rareori hipotensiune arterială
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
vârsta peste 65 ani.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
Utilizarea la copii şadolescenţ vârsta sub 18 ani
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
pentru a fi utilizată tratamentul copiilor şadolescenţ Studii Olanzapina nu este indicată
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
între 13 ş ani au evidenţ diverse reacţ adverse, efectuate la pacienţ vârsta cuprinsă
5 Lactose Zalasta tablets contain lactose.
5
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
incluzând creş în greutate, modifică ale parametrilor metabolici şcreş ale valorilor
4.5 Interaction with other medicinal products and other forms of interaction
concentraţ de prolactinăNu au fost studiate efectele pe termen lung asociate cu aceste evenimente
Interaction studies have only been performed in adults.
4. 8 ş5. 1). i
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.
intoleranţereditară galactozădeficienţde lactază galactoză.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
deoarece olanzapina este metabolizată CYP1A2, substanţ cu acţ specifică
Only slight to moderate increase in olanzapine clearance has been observed.
inhibitoare a acestei izoenzime pot afecta farmacocinetica olanzapinei.
Inhibition of CYP1A2 Fluvoxamine, a specific CYP 1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
tie fluvoxamina, inhibitor specific al CYP1A2, inhibă
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Creş terea medie a Cmax a olanzapinei după toare şde 77% la barbaţ nefumă Creş
The mean increase in olanzapine AUC was 52% and 108% respectively.
funcţ de timp (ASC) a olanzapinei a fost de 52%, respectiv 108%.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
fluvoxamina sau orice alţi inhibitori ai CYP1A2, cum ar fi ciprofloxacina, se recomandă
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
mai mici de olanzapinăLa instituirea unui tratament cu un inhibitor CYP1A2 se recomandă derea dozei de olanzapină.
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.
Reducerea biodisponibilită ii carbunele activat reduce biodisponibilitatea olanzapinei, administratăoral, cu 50 pânăla 60%, de aceea trebuie administrat cu cel putin 2 ore înainte sau dupăolanzapină.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
S– a constatat căfluoxetina (un inhibitor al CYP2D6), dozele unice de antiacide (aluminiu, magneziu) sau cimetidina nu afectează semnificativ farmacocinetica olanzapinei.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Potenţ olanzapinei de a afecta alte medicamente ialul olanzapina poate antagoniza efectele agoniş direcţ indirecţ dopaminei.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Olanzapina nu inhibă vitro principalele izoenzime CYP450 (de ex.
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).
De in aceea, nu apar interacţ particulare, fapt verificat prin studiile in vivo, în care nu s– a constatat iuni inhibarea metabolismului urmă toarelor substanţ active: antidepresivele triciclice (reprezentând în e special calea CYP2D6), warfarina (CYP2C9), teofilina (CYP1A2) sau diazepamul (CYP3A4 ş2C19). i
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Olanzapina nu a prezentat interacţ la co– administrarea cu litiu sau biperiden. iuni
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Activitatea generală SNC a ă Este necesară prudenţla pacienţ care consumă uturi alcoolice sau sunt în tratament cu
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
medicamente care pot determina deprimarea activită sistemului nervos central ş
6 4.6 Pregnancy and lactation
4. 6 Sarcina si alăptarea
There are no adequate and well-controlled studies in pregnant women.
Nu exista studii cu control adecvate şla femeile gravide.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Pacientele vor anunţ medicul în cazul apariţ sarcinii sau intenţ unei sarcini
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
experienţ limitate la om, olanzapina nu trebuie utilizată timpul sarcinii, decât dacă
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.
Foarte rar, au fost primite rapoarte spontane cu privire la tremor, hipertonie, letargie şsomnolenţ ă i apă la sugarii nascuţ mame care au utilizat olanzapina în cursul celui de– al 3- lea trimestru de
Lactation:
Alaptare: într- un studiu cu mame să toase care ală
In a study in lactating, healthy women, olanzapine was excreted in breast milk.
ptau, olanzapina a fost excretată laptele matern. în
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
olanzapină maternă (mg/ kg).
Patients should be advised not to breast feed an infant if they are taking olanzapine.
În timpul tratamentului cu olanzapină se recomandă ptarea.
4.7 Effects on ability to drive and use machines
Efecte asupra capacităii de a conduce vehicule şde a folosi utilaje ţ 4. 7 i
No studies on the effects on the ability to drive and use machines have been performed.
studii asupra efectelor medicamentului asupra capacită de a conduce vehicule şde a ţ Nu există folosi utilaje.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
olanzapina poate produce somnolenţşameţ, se recomandă ăi Datorită
4.8 Undesirable effects
faptului că
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.
la ie
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
operarea utilajelor, inclusiv condusul vehiculelor.
The frequency terms listed are defined as follows:
4. 8 Reacţ adverse ii
Very common (≥
Adulţ i Reacţ adverse raportate cel mai frecvent (observate la ≥ dintre pacienţ în studii clinice
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
1%
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
asociate cu utilizarea olanzapinei au fost somnolenţ creş în greutate, eozinofilie, creş
Very common
tere
Common
terea
Uncommon
4. 4), glucozurie, creş
Not known
terea
Blood and the lymphatic system disorders Immune system disorders
apetitului alimentar, ameţ acatizie, parkinsonism (vezi pct.
Eosinophilia
teri
Leukopenia Neutropenia
hepatice (vezi pct.
Thrombocytopenia Allergic reaction
reacţ adverse şmodifică investigaţ de laborator observate în Urmă
Metabolism and nutrition
torul tabel prezintă
disorders
iile i rile
Weight gain1
intă iile i
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
În cadrul fiecă grupe de frecvenţ reacţ ă
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
toare a gravită Frecvenţevenimentelor enumerate este ii. a 10%), frecvente ( ş
Nervous system disorders Somnolence
fi estimată datele disponibile). din
Dizziness Akathisia6
ă Foarte frecvente
Seizures where in most cases a history of
Mai puţ frecvente in
7
7 Tulbură metabolice şde nutriţ
Cardiac disorders
Ameţ eli Acatizie6
Parkinsonism6 Dyskinesia 6
6
seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Convulsii în majoritatea cazurilor
Vascular disorders
Tulbură cardiace ri
Bradycardia QT c prolongation (see section 4.4)
Parkinsonism Diskinezie
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
4. 4) Distonie (incluzând miş ri oculogire) că Diskinezie tardivă Simptomatologie dată de întreruperea tratamentului 7
Orthostatic hypotension
Bradicardie Prelungirea
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Tahicardie/ fibrilaţ ie ventricularămoarte,
Gastrointestinal disorders
Tulbură vasculare ri
Pancreatitis
subită (vezi pct.
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Tromboembolism (incluzând embolism pulmonar ştromboză i venoasă profundă)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Efecte anticolinergice uş oare, tranzitorii incluzând constipaţ ş ie i uscă ciunea gurii
Skin and subcutaneous tissue disorders
Tulbură hepatobiliare ri Creş tranzitorii,
Rash
teri
Photosensitivity reaction Alopecia
Hepatită (incluzând
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
asimptomatice ale valorilor transaminazelor
High creatine phosphokinase Increased total bilirubin
forme prin afectare hepatocelularăprin,
Increased alkaine phosphatase
hepatice (ALAT, ASAT),
Clinically significant weight gain was observed
colestază prin sau
across all baseline Body Mass
4. 4)
Index (BMI)
mecanism mixt)
categories.
Erupţ cutanată
Weight gain ≥ 7% of baseline body weight was very common and ≥
fotosensibilitate Alopecie Tulbură musculo- scheletice şale ţ
15% of baseline body
esutului conjunctiv
8
8 Tulbură renale şale că urinare
weight was common.
Creş
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
terea ≥15% faţde masa corporală ială fost frecventăCreş
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
momentul iniţ a fost observată 2
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
Modifică glicemiei iniţ în condiţ de repaus
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
7
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
5
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.
alimentar de la valori limită( ≥1, 69 mmol/ l - < 2, 26 mmol/ l) la valori crescute (≥2, 26 mmol/ l) au fost foarte frecvente.
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
În studiile clinice, incidenţparkinsonismului şa distoniei la pacienţ trataţ olanzapină fost 6
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Pacienţ trataţ olanzapină
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.
produce mai puţ diskinezie tardivă i/ sau alte sindroame extrapiramidale tardive. ină
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Simptome acute precum transpiraţ insomnie, tremor, anxietate, greaţşvă turi au fost raportate ă i rsă 7 ii, atunci când olanzapina a fost întreruptăbrusc.
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
Manifestă clinice asociate (de exemplu ginecomastia, galactoreea şmă 8
In most patients, levels returned to normal ranges without cessation of treatment.
La majoritatea pacienţ valorile au revenit în limitele normale fă întreruperea tratamentului.
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.
Expunere îndelungată( cel puţ 48 să mâni)
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 pacienţ adulţ
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).
s- a asociat cu o incidenţcrescută deceselor şa evenimentelor adverse cerebrovasculare (vezi şpct.
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Reacţ adverse foarte frecvente asociate cu utilizarea olanzapinei la acest grup de pacienţ fost tulbură
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
terea temperaturii corpului, letargie, eritem, halucinaţ vizuale şinconţ ă
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.
indusă medicamentos (agonist dopaminergic) asociată
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.
incidenţ de 4, 1% a neutropeniei; un factor potenţ care a contribuit la aceasta este concentraţ
Olanzapine administered with lithium or valproate resulted in increased levels ( 10%) of tremor, dry mouth, increased appetite, and weight gain.
De
Speech disorder was also reported commonly.
asemenea, s- au raportat frecvent (1% până 10%) tulbură 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).
olanzapină asociere cu litiu sau divalproex, în faza tratamentului acut (până 6 să mâni) la
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.
Tratamentul îndelungat cu olanzapină (până 12 luni) pentru prevenirea recurenţ la pacienţ cu
9 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Chiar
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.
Urmă torul tabel sumarizează reacţ adverse raportate cu o frecvenţmai mare la pacienţ
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.
adolescenţ( vârsta 13- 17 ani) faţde cei adulţ reacţ adverse identificate doar în cadrul studiilor
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Amploarea creş în greutate şproporţ pacienţ adolescenţ
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.
fost mai mari în cazul expunerii îndelungate (cel puţ 24 să mâni) decât în cazul expunerilor de scurtă durată
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
În cadrul fiecă grupe de frecvenţ reacţ adverse sunt prezentate în ordinea descrescă
The frequency terms listed are defined as follows:
după cum urmeazăfoarte frecvente:
Very common (≥ 10%), common (≥ 1% and < 10%).
( 1% i 10%).
Metabolism and nutrition disorders Very common:
Foarte frecvente:
Weight gain9, elevated triglyceride levels10, increased appetite.
Creş în greutate9, creş tere alimentar crescut. terea colesterolemiei11.
11 Common:
Frecvente:
Elevated cholesterol levels Nervous system disorders Very common:
Foarte frecvente: