natgillin/translations-raw huggingface dataset:
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.
deoarece olanzapina este metabolizată CYP1A2, substanţ cu acţ specifică
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Nu s– a observat decât creş
Only slight to moderate increase in olanzapine clearance has been observed.
Consecinţ clinice sunt, probabil, limitate, dar se recomandă
90 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
Spontaneous reports have been ver y 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
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 appet ite, 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
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
4. 4), glucozurie, creş
Very common
intă iile i
Common
rilor
Not known
Eozinofilie
Blood and the lymphatic system disorders Immune system disorders
Tulbură ale sistemului imunitar ri Reacţ alergică ie
Eosinophilia
Creşterea
Leukopenia Neutropenia
exacerbarea diabetului
Thrombocytopenia Allergic reaction
Creş tereatrigliceridemiei2, 5
91 Metabolism and nutrition disorders Weight gain1
ocazional cu cetoacidoză comă sau,
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
4. 4) Hipotermie
Nervous system disorders Somnolence
Tulbură ale sistemului nervos ri ă Somnolenţ
Dizziness Akathisia6
Ameţ eli Acatizie 6
Parkinsonism 6
6
seizures or risk factors
Convulsii în majoritatea cazurilor
Cardiac disorders
Tulbură cardiace ri
Dyskinesia
Parkinsonism Diskinezie
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
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
hepatice (ALAT, ASAT),
Skin and subcutaneous tissue disorders
78 Tulbură renale şale că urinare
Rash
ilor
Photosensitivity reaction Alopecia
Dificultate la iniţ ierea micţiunii
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders
Creş terea semnificativă greutate a fost observată ial la toate categoriile de Indici de masă
92 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
Creş terile medii ale concentraţ plasmatice a lipidelor în condiţ de repaus alimentar (colesterol
High creatine phosphokinase Increased total bilirubin
total, colesterol LDL ştrigliceride) au fost mai mari la pacienţ care nu au prezentat modifică
Increased alkaine phosphatase
valori crescute (≥6, 2 mmol/ l).
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
alimentarde la valori limită (≥5, 17 mmol/ l - < 6, 2 mmol/ l) la valori crescute (≥6, 2 mmol/ l) au fost foarte frecvente.
Weight gain ≥ 7% of baseline body weight was very common and ≥
7
15% of baseline body
rile
weight was common.
iale
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
ii
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
5
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
Modifică valorilor iniţ ale trigliceridelor în condiţ de repaus
93 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
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Chiar
Elevated cholesterol levels11 Nervous system disorders Very common:
Foarte frecvente:
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.
să mâni), aproximativ jumă dintre pacienţ adolescenţ avut o creş în greutate ≥15% ş
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
10
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).
atins valori crescute (≥1, 467 mmol/ l) şmodifică valorilor iniţ ale trigliceridelor în condiţ de
94 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.
Simptomele de supradozare foarte frecvente (incidenţ a > 10%) includ tahicardie, agitaţie/ agresivitate, disartrie, diferite simptome extrapiramidale şnivel de conş ă
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.
81 Studiile comportamentale cu olanzapină animale au ară că
In addition, a 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 imagisticăSPECT la pacienţcu schizofrenie a i ară că tat pacienţ responsivi la olanzapină un grad de ocupare a receptorilor striaţD2 mai mic
95 In a multinationational, 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).
La pacienţ cu episod maniacal sau mixt din tulburarile bipolare, olanzapina a demonstrat eficacitate ii superioară ă placebo şfaţde valproatul semisodic (divalproex) în privinţreducerii iă
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.
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.
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
4. 4
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
administrarea oralăatingând concentraţ plasmatică
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Absorbţ nu este influenţ de ingestia de alimente.
The absorption is not affected by food.
Biodisponibilitatea orală
Absolute oral bioavailability relative to intravenous administration has not been determined.
comparaţ cu administrarea intravenoasă a fost determinată
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
funcţ de vârstă i de sex. ie La vârstnicii (65 de ani şpeste) sanatoş în comparaţ cu subiecţ mai tineri, timpul mediu de înjumă ţ
96 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).
tă ire- eliminare plasmatică fost mai lung (51, 8 ore faţde 33, 8 ore), iar clearance– ul a fost a mai mic (17, 5 l/ oră ă 18, 2 l/ oră Variabilitatea farmacocinetică
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
83 Toxicitate acută doză
97 Haematologic toxicity:
. tere ş
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.
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Monohidrat de lactoză Pulbere de celuloză Amidon din porumb - pregelatinizat Amidon din porumb Siliciu coloidal anhidru Stearat de magneziu
6.4 Special precautions for storage
84 6. 4 Precauţ speciale pentru pă
6.5 Nature and contents of container
inutul ambalajului
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
Blistere (OPA/ Al/ PVC, folie de Al): cutie cu 14, 28, 35, 56 sau 70 comprimate.
98 7.
Ă 7.
EU/ 1/ 07/ 415/ 032-036
EU/ 1/ 07/ 415/ 027- 031
Zalasta 7.5 mg orodispersible tablets
Zalasta 5 mg comprimate orodispersabile
Each orodispersible tablet contains 7.5 mg olanzapine.
Fiecare comprimat orodispersabil conţ 5 mg olanzapină
Each orodispersible tablet contains 0.75 mg aspartame.
Fiecare comprimat conţ 0, 50 mg aspartam. ine
Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Comprimate rotunde, uş biconvexe, de culoare uş gă
100 Olanzapine can be given without regards for meals as absorption is not affected by food.
86 indiferent de orarul meselor, deoarece absorbţ medicamentului nu este afectată alimente.
Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
orodispersabil este dificilăDeoarece comprimatele orodispersabile sunt fragile, ele trebuie. administrate imediat după
Removal of the intact orodispersible tablet from the mouth is difficult.
deschiderea blisterului.
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Alternativ, ele pot fi dispersate într– un pahar plin cu
Alternatively, it may be dispersed in a full glass of water immediately before administration.
apă imediat înainte de administrare.
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Comprimatul orodispersabil de olanzapină este bioechivalent cu comprimatele filmate de olanzapină, având viteză i grad de absorbţ similare.
It has the same dosage and frequency of administration as olanzapine tablets.
aceeaşfrecvenţde administrare ca şcomprimatele filmate de olanzapinăComprimatele ă
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
orodispersabile de olanzapină fi utilizate ca alternativă comprimatele filmate de olanzapină
Dose escalation, when indicated, should be conservative in such patients.
necesită terapeutice, creş
In cases where dose increments of 2.5 mg are considered necessary, Zalasta tablets should be used.
necesare creş de doză câte 2, 5 mg, se va utiliza Zalasta comprimate teri de
(See sections 4.5 and 5.2.)
(vezi, de asemenea, pct.
During antipsychotic treatment, improvement in the patient's clinical condition may take severa l days to some weeks.
În timpul tratamentului antipsihotic, ameliorarea stă clinice a pacientului poate să
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
În studii clinice controlate ţi creş cu placebo (cu o durată 6- 12 să mâni) la pacienţvârstnici (vârsta medie 78 ani) cu psihoze ş
In placebo-controlled clinical trials (6-12 weeks
la pacienţ trataţ olanzapină
101 duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
comparativ cu cei la care s- a administrat placebo (3, 5%, respectiv
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
S- a înregistrat o creş de 3 ori a tere EACV la pacienţ trataţ olanzapină
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
88 Cu toate că olanzapina a demonstrat activitate anticolinergică vitro, experienţdin studiile clinice a
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and relat ed conditions.
Cu toate acestea, deoarece
102 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.
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).
103 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
Aspartame Zalasta orodispersible tablets contain aspartame, a source of phenylalanine.
Zalasta comprimate orodispersabile conţ aspartam, care este o sursă fenilalaninăNu se
May be harmful for people with phenylketonuria.
recomandată pacienţ cu fenilcetonurie. ilor
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
90 Olanzapina nu inhibă vitro principalele izoenzime CYP450 (de ex.
104 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
Uncommon
0, 1% ş
Not known
ş
Blood and the lymphatic system disorders Immune system disorders
i 0, 1%), foarte rare (< 0, 01%), cu frecvenţnecunoscută( care nu poate
Thrombocytopenia Allergic reaction
colesterolemiei2, 3 terea glicemiei4
105 Metabolism and nutrition disorders Weight gain1
ocazional cu cetoacidoză comă sau,
Nervous system disorders Somnolence
Tulbură ale sistemului nervos ri ă Somnolenţ Tulbură cardiace ri
6
Ameţ eli Acatizie 6 Parkinsonism6 Diskinezie6
Seizures where in most cases a history of
Tahicardie/ fibrilaţ ie ventricularămoarte,
Parkinsonism 6
Tulbură vasculare ri
seizures or risk factors
intervalului QTc (vezi pct.
Cardiac disorders
subită (vezi pct.
Dyskinesia
Hipotensiune arterială ortostatică
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Tromboembolism (incluzând embolism pulmonar ştromboză i venoasă profundă)
Vascular disorders
Pancreatită
Bradycardia QT c prolongation (see section 4.4)
Hepatită (incluzând
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
hepatice (ALAT, ASAT),
Orthostatic hypotension
special la iniţ ierea
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
4. 4) Afecţ cutanate şale ţ
Gastrointestinal disorders
esutului subcutanat
Mild, transient anticholinergic effects including constipation and dry mouth
fotosensibilitate Alopecie Tulbură musculo- scheletice şale ţ
Pancreatitis
Rabdomioliză
Hepato-biliary disorders
Astenie Oboseală Edeme
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Creş terea semnificativă greutate a fost observată ial la toate categoriile de Indici de masă
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
terea ≥15% faţde masa corporală ială fost frecventăCreş
Skin and subcutaneous tissue disorders
terea în greutate ≥25% faţde ă
Rash
creş
Photosensitivity reaction Alopecia
momentul iniţ a fost observată 2
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders
foarte frecvent la pacienţ trataţ termen lung. ii i pe
106 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
Creş terile medii ale concentraţ plasmatice a lipidelor în condiţ de repaus alimentar (colesterol
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
93 Manifestă clinice asociate (de exemplu ginecomastia, galactoreea şmă 8
107 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
Weight gain9, elevated triglyceride levels10, increased appetite.
Creş în greutate, creş alimentar crescut.
Elevated cholesterol levels11 Nervous system disorders Very common:
Creş Tulbură ale sistemului nervos ri ă Foarte frecvente:
Sedation (including: hypersomnia, lethargy, somnolence).
Sedare (incluzând hipersomnie, letargie, sedare, somnolenţ).
Gastrointestinal disorders Common:
Tulbură gastro- intestinale ri Frecvente:
Dry mouth Hepato-biliary disorders Very common:
94 Tulbură hepatobiliare ri Foarte frecvente:
108 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.
Simptomele de supradozare foarte frecvente (incidenţ a > 10%) includ tahicardie, agitaţie/ agresivitate, disartrie, diferite simptome extrapiramidale şnivel de conş ă
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α adrenergic; and histamine H1 receptors.
pentru serotonina 5 HT2A/ 2C; 5 HT3, 5 HT6; pentru dopamina D1, D2, D3, D4, D5; pentru receptorii colinergici muscarinici m1– m5; pentru receptorii α adrenergici; pentru receptorii histaminici H1.
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
1 Studiile comportamentale cu olanzapină animale au ară că
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
Spre deosebire de alţ i agenţ i antipsihotici, olanzapina determină raspuns crescut un la un test „ anxiolitic “.
109 In a multinationational, 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).
La pacienţ cu episod maniacal sau mixt din tulburarile bipolare, olanzapina a demonstrat eficacitate ii superioară ă placebo şfaţde valproatul semisodic (divalproex) în privinţreducerii iă
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
4. 4 ş4. 8). i
5.2 Pharmacokinetic properties
ţ 5. 2 Proprietăi farmacocinetice
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Comprimatul orodispersabil de olanzapină este bioechivalent cu comprimatele filmate de olanzapină, ş având viteză i grad de absorbţ similare.
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
Comprimatele orodispersabile de olanzapină fi utilizate
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Olanzapina se absoarbe bine dupăadministrarea oralăatingând concentraţ plasmatică
The absorption is not affected by food.
Absorbţ nu este influenţ de ingestia de alimente.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
La vârstnicii (65 de ani şpeste) sanatoş în comparaţ cu subiecţ mai tineri, timpul mediu de înjumă ţ
110 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).
tăire- eliminare plasmatică fost mai lung (51, 8 ore faţde 33, 8 ore), iar clearance– ul a fost a mai mic (17, 5 l/ oră ă 18, 2 l/ oră Variabilitatea farmacocinetică
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/ hr).
eliminare plasmatică fost ceva mai lung (36, 7 ore faţde 32, 3 ore), iar clearance– ul a fost mai mic a (18, 9 l/ oră
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
ă 27, 3 l/ oră Totuş olanzapina (5– 20 mg/ zi) a demonstrat un profil de siguranţ faţde). i,
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/ hr).
(clearance- ul creatininei < 10 ml/ min) faţde subiecţ
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
tat aproximativ 57% din olanzapina marcată
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
Legarea olanzapinei de proteinele plasmatice a fost de circa 93% în concentraţ cuprinse între ii aproximativ 7 ng/ ml şaproximativ 1000 ng/ ml.