natgillin/translations-raw huggingface dataset:
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.
Neutropenie Este necesar pruden la pacien ii cu valori sc zute ale num rului de leucocite i/ sau de neutrofile, indiferent de cauz, la pacien ii trata i cu medicamente cunoscute c determin neutropenie, la pacien ii cu antecedente de toxicitate/ deprimare medular determinate de medicamente, la pacien ii cu deprimare medular provocat de boli concomitente, radioterapie sau chimioterapie i la pacien ii cu hipereozinofilie sau cu boli mieloproliferative.
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.
Întreruperea tratamentului În cazul în care administrarea olanzapinei se întrerupe brusc, s- au raportat foarte rar (< 0, 01%) simptome acute cum ar fi transpira ii, insomnie, tremor, anxietate, grea sau v rs turi.
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.
Intervalul QT În studiile clinice, la pacien ii trata i cu olanzapin comparativ cu cei la care s- a administrat placebo prelungirea semnificativ clinic a intervalului QTc (corec ia tip Fridericia a intervalului QT [QTcF] 500 milisecunde [msec] în orice moment post- evaluare ini ial la pacien ii cu valori ini iale ale QTcF < 500 msec) a fost mai pu in frecvent (0, 1% pân la 1%), f r diferen e semnificative asupra evenimentelor cardiace asociate.
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.
Cu toate acestea, ca i în cazul altor antipsihotice, este necesar pruden când olanzapina se prescrie în asociere cu medicamente cunoscute ca prelungind intervalul QTc, în special la pacien ii vârstnici, la pacien ii cu sindrom QT prelungit congenital, cu insuficien cardiac congestiv, hipertrofie cardiac, hipokaliemie sau hipomagneziemie.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
Tromboembolism Asocierea temporal dintre tratamentul cu olanzapin i tromboembolismul venos s- a raportat foarte rar (< 0, 01%).
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Nu s- a stabilit o rela ie cauzal între apari ia tromboembolismului venos i tratamentul cu olanzapin.
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.
Cu toate acestea, deoarece pacien ii cu schizofrenie prezint adesea factori de risc pentru tromboembolism venos, to i factorii de risc de TEV, ca de exemplu imobilizarea pacien ilor, trebuie identifica i i trebuie luate m surile preventive necesare.
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.
Activitatea general asupra SNC Din cauza efectelor primare ale olanzapinei asupra sistemului nervos central (SNC), este necesar pruden atunci când aceasta se administreaz în asociere cu alte medicamente cu ac iune central i cu alcoolul etilic.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Deoarece prezint antagonism dopaminergic in vitro, olanzapina poate s ac ioneze antagonist fa de efectele agoni tilor dopaminergici direc i i indirec i.
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.
5 Convulsii Olanzapina trebuie utilizat cu pruden la pacien ii cu antecedente convulsive sau la cei expu i unor factori care pot s scad pragul convulsivant.
Seizures have been reported to occur rarely in patients when treated with olanzapine.
La pacien ii trata i cu olanzapin s- a raportat rareori apari ia convulsiilor.
5 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Diskinezie tardiv În studiile comparative cu durat de un an sau mai pu in, olanzapina s- a asociat cu o frecven mai mic, semnificativ statistic, a diskineziei iatrogene.
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.
Cu toate acestea, riscul de diskinezie tardiv cre te odat cu expunerea pe termen lung i, în consecin, dac la un pacient tratat cu olanzapin apar semne sau simptome de diskinezie tardiv, trebuie luat în considerare reducerea dozei sau întreruperea medicamentului.
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Simptomele se pot accentua în timp sau apar chiar dup întreruperea tratamentului.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Hipotensiune arterial postural În studiile clinice cu olanzapin la pacien ii vârstnici s- a observat rareori hipotensiune arterial postural.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
Ca în cazul altor antipsihotice, se recomand determinarea periodic a tensiunii arteriale la pacien ii în 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 i adolescen i sub 18 ani Olanzapina nu este indicat pentru a fi utilizat în tratamentul copiilor i adolescen ilor.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Studii efectuate la pacien i în vârst de 13- 17 ani au eviden iat diverse reac ii adverse, incluzând cre tere în greutate, modific ri ale parametrilor metabolici i cre teri ale nivelurilor prolactinei.
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
4. 8 i 5. 1).
Phenylalanine ZYPREXA VELOTAB orodispersible tablet contains aspartame, which is a source of phenylalanine.
Fenilalanina Comprimatul orodispersabil de ZYPREXA VELOTAB con ine aspartam, care este o surs de fenilalanin.
May be harmful for people with phenylketonuria.
Poate fi d un tor persoanelor cu fenilcetonurie.
Mannitol ZYPREXA VELOTAB orodispersible tablet contains mannitol.
Manitol Comprimatul orodispersabil de ZYPREXA VELOTAB con ine manitol.
Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate Olanzapine orodispersible tablet contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
Metil parahidroxibenzoat de sodiu i propil parahidroxibenzoat de sodiu Comprimatul orodispersabil de olanzapin con ine metil parahidroxibenzoat de sodiu i propil parahidroxibenzoat de sodiu.
These preservatives are known to cause urticaria.
Se tie c ace ti conservan i determin urticarie.
Generally, delayed type reactions such as contact dermatitis may occur, but rarely immediate reactions with bronchospasm may occur.
În general, pot s apar reac ii de tip intârziat, cum ar fi dermatita de contact, dar rar pot s apar i reac ii imediate cu bronhospasm.
Interaction studies have only been performed in adults.
Studiile privind interac iunile s- au efectuat doar la adul 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.
Interac iuni poten iale care afecteaz olanzapina Deoarece olanzapina este metabolizat de c tre CYP1A2, substan ele care pot induce sau inhiba specific aceast izoenzim pot afecta farmacocinetica olanzapinei.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Induc ia CYP1A2 Metabolizarea olanzapinei poate fi indus de fumat i de carbamazepin, ceea ce poate reduce concentra iile olanzapinei.
Only slight to moderate increase in olanzapine clearance has been observed.
S- a observat numai cre terea u oar pân la moderat a clearance- ului olanzapinei.
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Inhibi ia CYP1A2 S- a eviden iat c fluvoxamina, un inhibitor specific al CYP1A2, inhib semnificativ metabolizarea olanzapinei.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Cre terea medie a Cmax a olanzapinei dup fluvoxamin a fost de 54% la femeile
The mean increase in olanzapine AUC was 52% and 108% respectively.
Cre terea medie a 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.
La pacien ii care folosesc fluvoxamin sau orice al i inhibitori ai CYP1A2, cum ar fi ciprofloxacina, trebuie luat în considerare o doz ini ial mai mic de olanzapin.
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Trebuie avut în vedere sc derea dozei de olanzapin dac se instituie un tratament cu un inhibitor de CYP1A2.
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 biodisponibilit ii C rbunele activat reduce biodisponibilitatea dup administrarea oral a olanzapinei cu 50 pân la 60% i trebuie administrat cu cel pu in 2 ore înainte sau dup olanzapin.
6 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 c fluoxetina (un inhibitor al CYP2D6), dozele unice de antiacide (aluminiu, magneziu) sau cimetidina nu afecteaz semnificativ farmacocinetica olanzapinei.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Poten ialul ca olanzapina s afecteze alte medicamente Olanzapina poate antagoniza efectele agoni tilor direc i sau indirec i ai dopaminei.
1A2, 2D6, 2C9, 2C19, 3A4).
Olanzapina nu inhib in vitro principalele izoenzime CYP450 (de exemplu, 1A2, 2D6, 2C9, 2C19, 3A4).
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Astfel, nu se a teapt o interac iune special, fapt verificat prin studiile in vivo, în care nu s- a constatat inhibarea metaboliz rii urm toarelor substan e active: antidepresive triciclice (reprezentând în special calea CYP2D6), warfarin (CYP2C9), teofilin (CYP1A2) sau diazepam (CYP3A4 i 2C19).
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Olanzapina nu a prezentat interac iuni atunci când a fost asociat cu litiu sau biperiden.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Monitorizarea terapeutic a concentra iilor plasmatice ale valproatului nu a indicat necesitatea unei ajust ri a dozei de valproat dup introducerea concomitent a olanzapinei.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Activitatea general a SNC Este necesar pruden la pacien ii care consum b uturi alcoolice sau sunt în tratament cu medicamente care pot determina deprimarea sistemului nervos central.
There are no adequate and well-controlled studies in pregnant women.
Nu exist studii adecvate i bine controlate la femeile gravide.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Pacientelor trebuie s li se recomande s - i anun e medicul dac devin gravide sau inten ioneaz s devin gravide în timpul tratamentului cu olanzapin.
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Cu toate acestea, deoarece experien a la om este limitat, olanzapina nu trebuie folosit în timpul sarcinii decât dac beneficiul poten ial justific riscul poten ial pentru f t.
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.
S- au primit foarte rar raport ri spontane cu privire la tremor, hipertonie, letargie i somnolen, la sugari n scu i din mame care au utilizat olanzapin în cursul celui de- al 3- lea trimestru de sarcin.
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Într- un studiu la femei s n toase care al ptau, olanzapina s- a excretat în lapte.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Expunerea medie a sugarului (mg/ kg) la concentra ia de echilibru a fost estimat la 1, 8% din doza de olanzapin de la mam (mg/ kg).
Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Pacientelor trebuie s li se recomande s nu al pteze în timpul tratamentului cu olanzapin.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Deoarece olanzapina poate produce somnolen i ame eal, pacien ii trebuie avertiza i în leg tura cu operarea utilajelor, inclusiv a autovehiculelor.
4.8 Undesirable effects
7 4. 8 Reac ii adverse
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,
Adul i Reac iile adverse raportate cel mai frecvent (observate la 1% dintre pacien i) în studii clinice asociate cu utilizarea olanzapinei au fost somnolen a, cre terea în greutate, eozinofilia, cre terea nivelurilor prolactinei, colesterolului, glucozei i trigliceridelor (vezi pct.
7 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
4. 4), glucozuria, cre terea apetitului alimentar, ame eala, akatizia, parkinsonismul (vezi pct.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Urm torul tabel prezint reac iile adverse i investiga iile de laborator observate în timpul studiilor clinice precum i în urma raport rilor spontane.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
În cadrul fiec rei grupe de frecven, reac iile adverse sunt prezentate în ordinea descresc toare a gravit ii.
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).
Frecven a evenimentelor listate este definit dup cum urmeaz: foarte frecvente (≥10%), frecvente (≥1% i < 10%), mai pu in frecvente (≥0, 1% i < 1%), rare (0, 01 i < 0, 1%), foarte rare (< 0, 01%), frecven necunoscut (nu poate fi estimat din datele existente).
Uncommon
Mai pu in frecvente
Not known
Necunoscut
Blood and the lymphatic system disorders
Tulbur ri hematologice i limfatice
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Tulbur ri ale sistemului imunitar Reac ie alergic Tulbur ri metabolice i de nutri ie Cre tere în greutate1
Nervous system disorders Somnolence Cardiac disorders
Tulbur ri ale sistemului nervos Somnolen Tulbur ri cardiace
Dizziness Akathisia6 Parkinsonism6 Dyskinesia6
Ame eli Akatizie6 Parkinsonism6 Dyskinezie6
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
4. 4) Distonie (incluzând mi c ri oculogire) Diskinezie tardiv Simptomatologie dat de întreruperea tratamentului7
Vascular disorders
Bradicardie Prelungirea intervalului QTc (vezi pct.
Orthostatic hypotension
8 Tulbur ri vasculare
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Tromboembolism (incluzând embolism pulmonar i tromboz venoas profund)
Gastrointestinal disorders
Tulbur ri gastrointestinale Tulbur ri hepatobiliare
Mild, transient anticholinergic effects including constipation and dry mouth
Efecte anticolinergice u oare, tranzitorii incluzând constipa ie i usc ciunea gurii
Pancreatitis
Pancreatit
8 Hepato-biliary disorders
Cre teri tranzitorii, asimptomatice ale transaminazelor hepatice (ALAT, ASAT), în special la ini ierea tratamentului (vezi pct.
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Hepatit (incluzând forme prin afectare hepatocelular, prin colestaz sau prin mecanism mixt)
Rash
Erup ie cutanat
Photosensitivity reaction Alopecia
Reac ii de fotosensibilizare Alopecie
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 levels8 1
Tulbur ri musculo- scheletice i ale esutului conjunctiv Rabdomioliz Tulbur ri renale i ale c ilor urinare Ini ierea ezitant a mic iunii Tulbur ri ale aparatului genital i sânului Priapism Tulbur ri generale i la nivelul locului de administrare Astenie Oboseal Edeme Investiga ii diagnostice Concentra ii plasmatice crescute ale prolactinei8 1
High creatine phosphokinase Increased total bilirubin
Cre terea valorilor creatin fosfokinazei Cre terea valorilor bilirubinei totale
Increased alkaine phosphatase
Cre terea valorilor fosfatazei alcaline
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Cre terea semnificativ în greutate a fost observat ini ial la toate categoriile de Indici de Mas Corporal (IMC).
Weight gain 7% of baseline body weight was very common and 15% of baseline body weight was common.
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.
Patients gaining 25% of their baseline body weight with long-term exposure were very common.
Cre terea în greutate 25% fa de momentul ini ial a fost observat foarte frecvent la pacien ii trata i pe termen lung.
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
2 Cre terile medii ale lipidelor à jeun (colesterol total, colesterol LDL i trigliceride) au fost mai mari la pacien ii ce nu au prezentat modific ri ini iale ale lipidelor.
3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (6.2 mmol/ l).
3 Observat pentru valori ini iale normale à jeun (< 5, 17 mmol/ l) care au atins valori crescute (6, 2 mmol/ l).
Changes in total fasting cholesterol levels from borderline at baseline (5.17- < 6.2 mmol/ l) to high (6.2 mmol/ l) were very common.
Modific rile valorilor ini iale ale colesterolului à jeun de la valori limit (5, 17 mmol/ l - < 6, 2 mmol/ l) la valori crescute (6, 2 mmol/ l) au fost frecvente.
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (7 mmol/ l).
4 Observat pentru valori ini iale normale ale glicemiei à jeun (< 5, 56 mmol/ l) care au atins valori crescute (7 mmol/ l).
Changes in fasting glucose from borderline at baseline (5.56 - < 7 mmol/ l) to high (7 mmol/ l) were very common.
Modific rile glicemiei ini iale à jeun de la valori la limit (5, 56 - > 7 mmol/ l) la valori crescute (7 mmol/ l) au fost foarte frecvente.
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (2.26 mmol/ l).
9 5 Observat pentru valori ini iale normale à jeun (< 1, 69 mmol/ l) care au atins valori crescute (2, 26 mmol/ l).
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.
Modific rile valorilor ini iale ale trigliceridelor à jeun de la valori limit (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.
6 În studii clinice, inciden a parkinsonismului i distoniei la pacien ii trata i cu olanzapin a fost mai mare numeric, dar nu a fost semnificativ statistic diferit fa de placebo.
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Pacien ii trata i cu olanzapin au prezentat o inciden mai mic a parkinsonismului, akatisiei i distoniei comparativ cu pacien ii trata i cu doze progresive de haloperidol.
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.
În absen a unor informa ii detaliate privind antecedente individuale preexistente de tulbur ri motorii extrapiramidale acute i tardive, în prezent nu se poate concluziona c olanzapina produce mai pu in diskinezie tardiv i/ sau alte sindroame extrapiramidale tardive.
9 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 Simptome acute precum transpira ii, insomnie, tremor, anxietate, grea atunci când olanzapina a fost întrerupt brusc.
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
8
In most patients, levels returned to normal ranges without cessation of treatment.
La majoritatea pacien ilor valorile au revenit în limitele normale f r 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 îndelungat (cel pu in 48 s pt mâni) Propor ia pacien ilor care au înregistrat modific ri nedorite, semnificative clinic ale cre terii în greutate, glicemiei, raportului colesterol total/ LDL/ HDL sau al trigliceridelor, a crescut de- a lungul timpului.