natgillin/translations-raw huggingface dataset:
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
introducerea concomitentă olanzapinei. a
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Activitatea generală SNC a ă Este necesară prudenţla pacienţ care consumă uturi alcoolice sau sunt în tratament cu
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
medicamente care pot determina deprimarea activită sistemului nervos central ş
20 4.6 Pregnancy and lactation
20 Utilizarea concomitentă olanzapinei cu medicamente anti- parkinsoniene la pacienţ
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
În cadrul fiecă grupe de frecvenţ reacţ ă
21
21 Tulbură metabolice şde nutriţ
Cardiac disorders
Ameţ eli Acatizie 6
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 miş ri oculogire) că Diskinezie tardivă Simptomatologie dată de întreruperea tratamentului 7
Vascular disorders
Tulbură vasculare ri
Bradycardia QT c prolongation (see section 4.4)
4. 4)
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Tromboembolism (incluzând embolism pulmonar ştromboză i venoasă profundă)
Gastrointestinal disorders
Tulbură gastrointestinale ri
Mild, transient anticholinergic effects including constipation and dry mouth
Efecte anticolinergice uş oare, tranzitorii incluzând constipaţ ş ie i uscă ciunea gurii
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
forme prin afectare hepatocelularăprin,
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
hepatice (ALAT, ASAT),
Skin and subcutaneous tissue disorders
colestază prin sau
Rash
4. 4)
Photosensitivity reaction Alopecia
Afecţ cutanate şale ţ
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
iuni i
High creatine phosphokinase Increased total bilirubin
esutului subcutanat
Increased alkaine phosphatase
Erupţ cutanată
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
fotosensibilitate Alopecie Tulbură musculo- scheletice şale ţ
Weight gain ≥ 7% of baseline body weight was very common and ≥
esutului conjunctiv
15% of baseline body
Rabdomioliză
22
22 Tulbură renale şale că urinare
23 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Chiar
Metabolism and nutrition disorders Very common:
4. 4). teri Investigaţ diagnostice ii Foarte frecvente:
Weight gain9, elevated triglyceride levels10, increased appetite.
Scă derea valorilor bilirubinei totale, creş terea valorilor GGT, concentraţ plasmatice ii crescute ale prolactinei 12.
11 Common:
11
Sedation (including: hypersomnia, lethargy, somnolence).
(≥1, 016 mmol/ l - < 1, 467 mmol/ l) la valori crescute (≥
Dry mouth Hepato-biliary disorders Very common:
Modifică ale valorilor colesterolului total, normale iniţ în condiţ de repaus alimentar (<
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
4, 39 mmol/ l) şcare au atins valori crescute (≥5, 17 mmol/ l) s- au observat frecvent.
Investigations Very common:
Modifică
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
valorilor iniţ ale colesterolului total în condiţ de repaus alimentarde la valori limită
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
(≥
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.
4, 39 mmol/ l - < 5, 17 mmol/ l) la valori crescute (≥5, 17 mmol/ l) au fost foarte frecvente.
24 Management of overdose There is no specific antidote for olanzapine.
Nu exista un antidot specific pentru olanzapinăNu se recomandă
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
25 Studiile comportamentale cu olanzapină animale au ară că
25 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.
olanzapinei 10 mg (în tratament combinat cu litiu sau valproat) a dus, după să mâni de tratament, 6 ptă la o reducere mai mare a simptomelor maniacale, decat în cazul monoterapiei cu litiu sau cu valproat.
26 In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
(39, 3 ore) a fost prelungit şclearance– ul (18 l/ orăa fost redus, în comparaţ cu subiecţ plasmat
The pharmacokinetics of olanzapine are similar between adolescents and adults.
mică i faptul că puţ adolescenţerau fumă Este posibil ca asemenea factori să
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
27 Toxicitate acută doză
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
toare au fost cele caracteristice pentru compuş neuroleptici potenţ ii
Such factors possibly contribute to the higher average exposure observed in adolescents.
Dozele letale ţ scă
5.3 Preclinical safety data
oareci) ş175 mg/ kg (ş med
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
ii au fost de aproximativ 210 mg/ kg (ş i
27 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
mutaţ bacteriene şteste in vitro şin vivo la mamifere.
6.4 Special precautions for storage
28 6. 4 Precauţ speciale pentru pă
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Medicamentului (EMEA) http: // www. emea. europa. eu
Zalasta 7.5 mg tablets
Zalasta 7, 5 mg comprimate
Each tablet contains 7.5 mg olanzapine.
Fiecare comprimat conţ 7, 5 mg olanzapină
Each tablet contains 121.3 mg lactose.
Fiecare comprimat conţ 121, 3 mg lactoză
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 7.5”.
Comprimatele sunt rotunde, uş biconvexe, de culoare uş gă gă şinscripţ
CLINICAL PARTICULARS
ionate “ 7, 5 ”.
30 Olanzapine can be given without regards for meals as absorption is not affected by food.
30 indiferent de orarul meselor, deoarece absorbţ medicamentului nu este afectată alimente.
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
4. 4, 4. 8, 5. 1 ş5. 2). prolactinemiei decât în studiile la pacienţ.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
iunile pulmonare (de exemplu pneumonia de aspiraţ sau
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Cu toate acestea, independent de factorii de risc a enumeraţ incidenţdeceselor a fost mai mare în rândul pacienţ trataţ olanzapină
There was a 3-fold increase in CVAE in patients treated
cu cei la care s- a administrat placebo.
31 with olanzapine compared to patients treated with placebo (1.3% vs.
31 În aceleaşstudii s- au raportat evenimente adverse cerebrovasculare (EACV, de exemplu accident i vascular cerebral, accident ischemic tranzitor) inclusiv decese.
32 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.
32 Neutropenie
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical tria ls.
În studiile clinice cu olanzapină pacienţ vârstnici s- a observat rareori hipotensiune arterială
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
icu
33 Lactose Zalasta tablets contain lactose.
33 pentru a fi utilizată tratamentul copiilor şadolescenţ Studii Olanzapina nu este indicată
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
ajustă a dozei de valproat, după
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
ri
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
introducerea concomitentă olanzapinei. a
34 4.6 Pregnancy and lactation
34 Activitatea generală SNC a ă Este necesară prudenţla pacienţ care consumă uturi alcoolice sau sunt în tratament cu
35
35 Tulbură metabolice şde nutriţ
36
36 Tulbură renale şale că urinare
37 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Chiar
38 Management of overdose There is no specific antidote for olanzapine.
Nu exista un antidot specific pentru olanzapinăNu se recomandă
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
39 Studiile comportamentale cu olanzapină animale au ară că
39 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.
olanzapinei 10 mg (în tratament combinat cu litiu sau valproat) a dus, după să mâni de tratament, 6 ptă la o reducere mai mare a simptomelor maniacale, decat în cazul monoterapiei cu litiu sau cu valproat.
40 In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
(39, 3 ore) a fost prelungit şclearance– ul (18 l/ orăa fost redus, în comparaţ cu subiecţ plasmat
5.3 Preclinical safety data
41 Toxicitate acută doză
Reproductive toxicity Olanzapine had no teratogenic effects.
La ş Olanzapina nu prezintă
41 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
mutaţ bacteriene şteste in vitro şin vivo la mamifere.
6.4 Special precautions for storage
42 6. 4 Precauţ speciale pentru pă
Each tablet contains 10 mg olanzapine.
Fiecare comprimat conţ 10 mg olanzapină
Each tablet contains 161.8 mg lactose.
Fiecare comprimat conţ 161, 8 mg lactoză
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 10”.
ionate “ 10 ”.
44 Olanzapine can be given without regards for meals as absorption is not affected by food.
44 indiferent de orarul meselor, deoarece absorbţ medicamentului nu este afectată alimente.
When more than one factor is present which might result in slower metabolism (femal e gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
feminin, vârstăînaintatănefumator), se va lua în considerare scă
45 with olanzapine compared to patients treated with placebo (1.3% vs.
45 EACV la pacienţ trataţ olanzapină
46 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).
47 Lactose Zalasta tablets contain lactose.
47
48 4.6 Pregnancy and lactation
48 Utilizarea concomitentă olanzapinei cu medicamente anti- parkinsoniene la pacienţ
49
49 Tulbură metabolice şde nutriţ
50
50 Tulbură renale şale că urinare
51 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Chiar
52 Management of overdose There is no specific antidote for olanzapine.
Nu exista un antidot specific pentru olanzapinăNu se recomandă
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
53 Studiile comportamentale cu olanzapină animale au ară că
53 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.
olanzapinei 10 mg (în tratament combinat cu litiu sau valproat) a dus, după să mâni de tratament, 6 ptă la o reducere mai mare a simptomelor maniacale, decat în cazul monoterapiei cu litiu sau cu valproat.
54 In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
(39, 3 ore) a fost prelungit şclearance– ul (18 l/ orăa fost redus, în comparaţ cu subiecţ plasmat
5.3 Preclinical safety data
55 Toxicitate acută doză
55 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
mutaţ bacteriene şteste in vitro şin vivo la mamifere.
6.4 Special precautions for storage
56 6. 4 Precauţ speciale pentru pă
7, 14, 28, 35, 56 or 70 tablets in a box.
Blistere (OPA/ Al/ PVC, folie de Al): cutie cu 7, 14, 28, 35, 56 sau 70 comprimate.
Each tablet contains 15 mg olanzapine.
Fiecare comprimat conţ 15 mg olanzapină
Each tablet contains 242.7 mg lactose.
Fiecare comprimat conţ 242, 7 mg lactoză
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 15”.
ionate “ 15 ”.
58 Olanzapine can be given without regards for meals as absorption is not affected by food.
58 indiferent de orarul meselor, deoarece absorbţ medicamentului nu este afectată alimente.
59 with olanzapine compared to patients treated with placebo (1.3% vs.
59 EACV la pacienţ trataţ olanzapină
60 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).
61 Lactose Zalasta tablets contain lactose.
61
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Interacţ cu alte medicamente şalte forme de interacţ 4. 5
Only slight to moderate increase in olanzapine clearance has been observed.
Studiile privind interacţ iunile s- au efectuat doar la adulţ i.
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).
deoarece olanzapina este metabolizată CYP1A2, substanţ cu acţ specifică
Inhibition of CYP1A2 Fluvoxamine, a specific CYP 1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
inhibitoare a acestei izoenzime pot afecta farmacocinetica olanzapinei.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Nu s– a observat decât creş
The mean increase in olanzapine AUC was 52% and 108% respectively.
terea uş - moderată clearance– ului oară a
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Consecinţ clinice sunt, probabil, limitate, dar se recomandă
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
monitorizarea clinică i,
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.
4. 2).
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
tie fluvoxamina, inhibitor specific al CYP1A2, inhibă
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
semnificativ metabolismul olanzapinei.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Creş terea medie a Cmax a olanzapinei după toare şde 77% la barbaţ nefumă Creş
1A2, 2D6, 2C9, 2C19, 3A4).
funcţ de timp (ASC) a olanzapinei a fost de 52%, respectiv 108%.
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).
fluvoxamina sau orice alţi inhibitori ai CYP1A2, cum ar fi ciprofloxacina, se recomandă
Olanzapine showed no interaction when co-administered with lithium or biperiden.
mai mici de olanzapinăLa instituirea unui tratament cu un inhibitor CYP1A2 se recomandă derea dozei de olanzapină.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant 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.
CNS medicinal products Caution should be exercised in patients who receive medicinal products that can cause central nervous system depression and alcohol.
S– a constatat căfluoxetina (un inhibitor al CYP2D6), dozele unice de antiacide (aluminiu, magneziu) sau cimetidina nu afectează semnificativ farmacocinetica olanzapinei.
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Potenţ olanzapinei de a afecta alte medicamente ialul olanzapina poate antagoniza efectele agoniş direcţ indirecţ dopaminei.
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
1A2, 2D6, 2C9, 2C19, 3A4).
62 4.6 Pregnancy and lactation
62 Utilizarea concomitentă olanzapinei cu medicamente anti- parkinsoniene la pacienţ
63
63 Tulbură metabolice şde nutriţ
64
64 Tulbură renale şale că urinare
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
Proporţ pacienţ care au înregistrat modifică nedorite, semnificative clinic ale creş în
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
La pacienţ adulţ
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.
ii
Olanzapine administered with lithium or valproate resulted in increased levels ( 10%) of tremor, dry mouth, increased appetite, and weight gain.
i care au încheiat o perioada de tratament de 9- 12 luni, rata de creş a tere
Speech disorder was also reported commonly.
valorilor medii ale glicemiei s- a încetinit după aproximativ 4- 6 luni.
65 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
65 Informaţ suplimentare referitoare la grupe speciale de pacienţ
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.
În studiile clinice la pacienţvârstnici cu demenţ tratamentul cu olanzapină
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.
s- a asociat cu o incidenţcrescută deceselor şa evenimentelor adverse cerebrovasculare (vezi şpct.
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
i
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Reacţ adverse foarte frecvente asociate cu utilizarea olanzapinei la acest grup de pacienţ fost tulbură
The frequency terms listed are defined as follows:
iile de mers şcă rile
Very common (≥ 10%), common (≥ 1% and < 10%).
Frecvent s- au observat pneumonie, creş
Weight gain9, elevated triglyceride levels10, increased appetite.
terea temperaturii corpului, letargie, eritem, halucinaţ vizuale şinconţ ă
11 Common:
ii i
Sedation (including: hypersomnia, lethargy, somnolence).
inenţurinară.
Gastrointestinal disorders Common:
În studiile clinice la pacienţ cu psihoză
Dry mouth Hepato-biliary disorders Very common:
indusă medicamentos (agonist dopaminergic) asociată
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
boala Parkinson, s- au raportat foarte frecvent şmai frecvent decât după
Investigations Very common:
administrarea de placebo
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
agravarea simptomatologiei parkinsoniene şa halucinaţ
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
Într- un studiu clinic la pacienţ manie bipolarăterapia asociată valproat şolanzapină dus la o
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.
incidenţ de 4, 1% a neutropeniei; un factor potenţ care a contribuit la aceasta este concentraţ
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
Olanzapina administrată litiu sau valproat a dus la creş
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).
De
11 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/ l) to high (≥ 5.17 mmol/ l) were observed commonly.
În timpul tratamentului cu
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.
olanzapină asociere cu litiu sau divalproex, în faza tratamentului acut (până 6 să mâni) la