natgillin/translations-raw huggingface dataset:
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
Olanzapina se leagă i α– glicoproteina acidă.
5.3 Preclinical safety data
Toxicitate acută doză
111 Haematologic toxicity:
. tere ş
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Manitol Celuloză microcristalină Crospovidonă Hidroxipropilceluloză Aspartam Silicat de calciu Stearat de magneziu
6.4 Special precautions for storage
6. 4 Precautii speciale pentru pă strare
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
Zalasta comprimate orodispersabile este disponibilă cutii cu blistere (Al/ OPA/ Al/ PVC) cu 14, 28, în 35, 56 sau 70 comprimate.
112 7.
Ă 7.
EU/ 1/ 07/ 415/ 037-041
EU/ 1/ 07/ 415/ 032- 036
Date of first authorisation:
RI
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Data primei autoriză 27 Septembrie 2007. ri:
Zalasta 10 mg orodispersible tablets
DATA REVIZUIRII TEXTULUI
2.
ii
QUALITATIVE AND QUANTITATIVE COMPOSITION
DENUMIREA COMERCIALĂA MEDICAMENTULUI
Each orodispersible tablet contains 10 mg olanzapine.
Zalasta 7, 5 mg comprimate orodispersabile
Each orodispersible tablet contains 1.00 mg aspartame.
Fiecare comprimat conţ 0, 75 mg aspartam. ine
Olanzapine can be given without regards for meals as absorption is not affected by food.
101 indiferent de orarul meselor, deoarece absorbţ medicamentului nu este afectată alimente.
114 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
In placebo-controlled clinical trials (6-12 weeks 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
În studii clinice controlate ţi creş cu placebo (cu o durată 6- 12 să mâni) la pacienţvârstnici (vârsta medie 78 ani) cu psihoze ş
115 compared to patients treated with placebo (3.5% vs.
comparativ cu cei la care s- a administrat placebo (3, 5%, respectiv
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
103 Cu toate că olanzapina a demonstrat activitate anticolinergică vitro, experienţdin studiile clinice a
116 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.
117 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
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
105 Olanzapina nu inhibă vitro principalele izoenzime CYP450 (de ex.
118 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
Common
rile
Uncommon
iilor
Not known
rilor
Blood and the lymphatic system disorders Immune system disorders
10%), frecvente ( ş definită după cum urmeazăfoarte frecvente (
Eosinophilia
0, 1% ş
Leukopenia Neutropenia
i 1%), rare (≥
Thrombocytopenia Allergic reaction
fi estimată datele disponibile). din
Metabolism and nutrition
ă Foarte frecvente
Weight gain1
Eozinofilie
Elevated cholesterol
Leucopenie Neutropenie
Development or
Trombocitopenie
119
tere
levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
4. 4) Hipotermie
exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Tulbură ale sistemului nervos ri ă Somnolenţ Tulbură cardiace ri
Dizziness Akathisia6 Parkinsonism6 Dyskinesia 6
Ameţ eli Acatizie 6 Parkinsonism6 Diskinezie6
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 miş ri oculogire) că Diskinezie tardivă Simptomatologie dată de întreruperea tratamentului 7
Mild, transient anticholinergic effects including constipation and dry mouth
Efecte anticolinergice uşoare, tranzitorii incluzând constipaţ ş ie i uscă ciunea gurii
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
4. 4) Afecţ cutanate şale ţ
Skin and subcutaneous tissue disorders
Tulbură renale şale că urinare
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions
Tulbură generale şla nivelul locului de administrare
120 Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
plasmatice crescute ale prolactinei 8 1
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
108 Manifestă clinice asociate (de exemplu ginecomastia, galactoreea şmă 8
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
incidenţ de 4, 1% a neutropeniei; un factor potenţ care a contribuit la aceasta este concentraţ
121 valproate levels.
plasmatică crescută valproatului.
Dry mouth Hepato-biliary disorders Very common:
109 Tulbură hepatobiliare ri Foarte frecvente:
122 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 a multinationational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms
simptomelor iniţ până sfârş tratamentului, a demonstrat o ameliorare semnificativă
123 (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 healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
La vârstnicii (65 de ani şpeste) sanatoş în comparaţ cu subiecţ mai tineri, timpul mediu de înjumă ţ
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
încadrează plaja de variaţ pentru non– vârstnici.
In 44
La 44 de pacienţ schizofrenie în vârstă
124 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
peste 65 de ani, dozele între 5 ş20 mg/ zi nu au produs un profil deosebit al reacţ adverse.
Reversible
duvei
125 neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
La câţ câini trataţ 8 sau 10 mg/ kg pe zi (expunere totală olanzapină ASC -
126 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 07/ 415/ 042-046
EU/ 1/ 07/ 415/ 037- 041
127 1.
115 1.
Zalasta 15 mg orodispersible tablets
Zalasta 10 mg comprimate orodispersabile
Each orodispersible tablet contains 15 mg olanzapine.
Fiecare comprimat orodispersabil conţ 10 mg olanzapină
Each orodispersible tablet contains 1.50 mg aspartame.
Fiecare comprimat conţ 1, 00 mg aspartam. ine
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
clinice în timpul tratamentului de întreţ rii inere, la
128 Olanzapine can be given without regards for meals as absorption is not affected by food.
116 indiferent de orarul meselor, deoarece absorbţ medicamentului nu este afectată alimente.
129 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
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.
Hiperglicemie şdiabet zaharat i Rar s– au raportat hiperglicemie ş i/ sau apariţ sau agravarea diabetului, asociate ocazional cu ia ţ cetoacidoza sau coma, inclusiv cazuri letale (vezi pct.
8).
4. 8).
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
118 Cu toate că olanzapina a demonstrat activitate anticolinergică vitro, experienţdin studiile clinice a
130 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.
131 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
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
120 Olanzapina nu inhibă vitro principalele izoenzime CYP450 (de ex.
132 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 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 nascuţdin mame care au utilizat olanzapina în cursul celui de– al 3- lea trimestru de
133 Metabolism and nutrition disorders Weight gain1
ocazional cu cetoacidoză comă sau,
134 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.
123 Manifestă clinice asociate (de exemplu ginecomastia, galactoreea şmă 8
135 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
Dry mouth Hepato-biliary disorders Very common:
124 Tulbură hepatobiliare ri Foarte frecvente:
136 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
137 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
138 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
139 Haematologic toxicity:
. tere ş
140 7.
Ă 7.
EU/ 1/ 07/ 415/ 047-051
EU/ 1/ 07/ 415/ 042- 046
141 1.
130 1.
Zalasta 20 mg orodispersible tablets
Zalasta 15 mg comprimate orodispersabile
Each orodispersible tablet contains 20 mg olanzapine.
Fiecare comprimat orodispersabil conţ 15 mg olanzapină
Each orodispersible tablet contains 2.00 mg aspartame.
Fiecare comprimat conţ 1, 50 mg aspartam. ine
142 Olanzapine can be given without regards for meals as absorption is not affected by food.
131 indiferent de orarul meselor, deoarece absorbţ medicamentului nu este afectată alimente.
Children and adolescentsOlanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Olanzapina nu este recomandata pentru utilizare la copii şadolescenţ vârsta sub 18 ani datorită
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed
În studii clinice controlate ţi creş cu placebo (cu o durată 6- 12 să mâni) la pacienţvârstnici (vârsta medie 78 ani) cu psihoze ş
143 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
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
133 Cu toate că olanzapina a demonstrat activitate anticolinergică vitro, experienţdin studiile clinice a
144 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.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
congestivăhipertrofie cardiacăhipokaliemie sau hipomagneziemie.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
dintre tratamentul cu olanzapină i tromboembolismul venos s- a raportat foarte între apariţ tromboembolismului venos ştratamentul
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 olanzapinăCu toate acestea, deoarece pacienţ cu schizofrenie prezintă
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 generală asupra SNC Ca urmare a efectelor olanzapinei în primul rând asupra sistemului nervos central (SNC), este necesară
145 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
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
135 Olanzapina nu inhibă vitro principalele izoenzime CYP450 (de ex.
146 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
147
tere
148 Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
plasmatice crescute ale prolactinei 8 1
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
138 Manifestă clinice asociate (de exemplu ginecomastia, galactoreea şmă 8
149 valproate levels.
plasmatică crescută valproatului.
Dry mouth Hepato-biliary disorders Very common:
139 Tulbură hepatobiliare ri Foarte frecvente:
150 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
151 (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
152 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
peste 65 de ani, dozele între 5 ş20 mg/ zi nu au produs un profil deosebit al reacţ adverse.
153 neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
La câţ câini trataţ 8 sau 10 mg/ kg pe zi (expunere totală olanzapină ASC -
154 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenia ka
EU/ 1/ 07/ 415/ 052-056
EU/ 1/ 07/ 415/ 047- 051
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Fiecare comprimat orodispersabil conţ 20 mg olanzapină
Date of first authorisation:
Excipient:
27 September 2007.
FORMA FARMACEUTICĂ
DATE OF REVISION OF THE TEXT
DATE CLINICE
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
5. 1). este
155 ANNEX II
iniţ este
A.
ii
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
pentru tratamentul episoadelor maniacale, tratamentul de
B.
cu
CONDITIONS OF THE MARKETING AUTHORISATION
trebuie continuat (cu ajustarea dozelor dacă
156 A.
rilor
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
bipolare, doza zilnică poate fi ajustată funcţ de starea clinică
Name and address of the manufacturers responsible for batch release
Creş terea dozei peste cea iniţ recomandată indicată
KRKA, d. d., Novo mesto Š marješ cesta 6, 8501 Novo mesto ka Slovenia
nu trebuie realizatăîn general, la intervale mai mici de 24 ore.
KRKA Polska Sp. z o. o.
deschiderea blisterului.
Ul.
.
Równoległ 5, Warszawa a Poland
i trebuie luată considerare o doza iniţ scă (5 mg).
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
La nefumatori, în comparaţ cu fumatorii, nu este necesară
B.
ie
CONDITIONS OF THE MARKETING AUTHORISATION
modificarea dozei iniţ iale.
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
In cazul prezenţ mai multor factori ce pot determina metabolizarea mai lentă medicamentului (sex
Medicinal product subject to medical prescription.
terea dozelor se va face cu prudenţ( vezi cap 4. 5 ş5. 2.). ă
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
necesare creş de doză câte 2, 5 mg, se va utiliza Zalasta comprimate teri de
Not aplicable.
filmate.
 OTHER CONDITIONS
4. 3 Contraindicaţ ii
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
tulbură de comportament asociate demenţ s- a înregistrat o creş de 2 ori a incidenţ deceselor
PSURs The PSUR submission schedule for Zalasta tablets and orodispersible tablets should follow PSURs submission schedule for the reference medicinal product.
Factorii de risc care pot predispune această de pacienţ creş
157 ANNEX III
etiologie) sau
LABELLING AND PACKAGE LEAFLET
utilizarea concomitentă benzodiazepinelor.
158 A.
ilor
LABELLING
comparativ
159 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
comparativ cu cei la care s- a administrat placebo (1, 3%,
CARTON FOR ZALASTA 2.5 mg TABLETS
Boala Parkinson Nu se recomandă
NAME OF THE MEDICINAL PRODUCT
dozăeficace de medicaţ ie
Zalasta 2.5 mg tablets Olanzapine
iparkinsoniană i ră cu i
STATEMENT OF ACTIVE SUBSTANCE(S)
Sindrom Neuroleptic Malign (SNM)
Each tablet contains 2.5 mg olanzapine.
semne şsimptome care indică
3.
) i
LIST OF EXCIPIENTS
bolnavul dezvoltă
Contains lactose monohydrate.
olanzapina, trebuie întrerupte.
See package leaflet for further information.
monitorizarea clinică adecvată i controlul periodic al glicemiei.
4.
4. 8).
PHARMACEUTICAL FORM AND CONTENTS
i/ sau ASAT crescute, la pacienţ
14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
cu semne şsimptome de insuficienţhepaticăla ă
5.
cu
METHOD AND ROUTE(S) OF ADMINISTRATION
funcţ ională hepaticălimitată i la
Read the package leaflet before use.
pacienţ trataţ medicamente cu potenţ hepatotoxic.
Oral use.
dozei.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
indiferent de cauzăla pacienţ trataţcu medicamente cunoscute că
Keep out of the reach and sight of children.
pacienţ cu antecedente de toxicitate/ deprimare medulară
OTHER SPECIAL WARNING(S), IF NECESSARY
determinate de medicamente, la pacienţ cu ii
8.
ă
EXPIRY DATE
La întreruperea
EXP:
rsă
9.
,
SPECIAL STORAGE CONDITIONS
reducerea gradată dozei. a
10.
i cu
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
≥ milisecunde [msec] în orice moment post- evaluare iniţ la pacienţ cu valori iniţ ale 500 QTcF < 500 msec) a fost mai puţ frecventă
160 11.
ială
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
1%), fă diferenţsemnificative asupra la ră e
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Cu toate acestea, similar altor antipsihotice, este necesară
12.
ii
MARKETING AUTHORISATION NUMBER(S)
pentru tromboembolism venos, toţ
EU/ 1/ 07/ 415/ 001 (14 tablets) EU/ 1/ 07/ 415/ 002 (28 tablets) EU/ 1/ 07/ 415/ 003 (35 tablets) EU/ 1/ 07/ 415/ 004 (56 tablets) EU/ 1/ 07/ 415/ 005 (70 tablets)
Activitatea generală asupra SNC Ca urmare a efectelor olanzapinei în primul rând asupra sistemului nervos central (SNC), este necesară
13.
în
BATCH NUMBER
cu alcoolul etilic.
Batch:
tilor
GENERAL CLASSIFICATION FOR SUPPLY
factori care pot săscadă pragul convulsivant.