natgillin/translations-raw huggingface dataset:
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.
94 Znaki in simptomi Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca > 10%) vključ ujejo tahikardijo, vznemirjenost/ nasilnost, dizartrijo, različ ekstrapiramidne simptome in motnje zavesti v razponu od ne sedacije do kome.
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.
Slikovna raziskava SPECT (Single Photon Emission Computed Tomography) je pri bolnikih s shizofrenijo razkrila, da je bila zasedenost striatnih receptorjev D2 pri bolnikih, ki so se odzivali na olanzapin, manjš kot pri bolnikih, ki so se odzivali na nekatere druge antipsihotike in na risperidon, a medtem ko je bila primerljiva z bolniki, ki so se odzivali na klozapin.
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).
simptomov (izhodišna srednja vrednost 16, 6 na Montgomery- Asbergovi lestvici ocenjevanja č depresije), je prospektivna sekundarna analiza spremembe od izhodišne do konč ocenene razpolož pokazala statistič znač izboljš (p = 0, 001) v korist olanzapina (– 6) v primerjavi
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Podobni sta tudi hitrost in obseg absorpcije.
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).
96 Pri zdravih starejš osebah (65 let in več je bil v primerjavi z mlajš osebami srednji razpolovni
111 Haematologic toxicity:
97 Hematološ toksič
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
manitol mikrokristalna celuloza krospovidon hidroksipropilceluloza aspartam kalcijev silikat magnezijev stearat
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
Zalasta orodisperzibilne tablete so na voljo v š katlah s 14, z 28, s 35, 56 ali 70 tabletami v pretisnih omotih (Al/ OPA/ Al/ PVC).
112 7.
98 7.
8.
Š 8.
Zalasta 10 mg orodispersible tablets
Zalasta 7, 5 mg orodisperzibilne tablete
Each orodispersible tablet contains 10 mg olanzapine.
1 orodisperzibilna tableta vsebuje 7, 5 mg olanzapina.
Each orodispersible tablet contains 1.00 mg aspartame.
Pomož snov: na 1 orodisperzibilna tableta vsebuje 0, 75 mg aspartama.
Olanzapine can be given without regards for meals as absorption is not affected by food.
100 Bolniki lahko jemljejo olanzapin ne glede na obroke, ker hrana ne vpliva na absorpcijo.
114 Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Ker je krhka, jo je treba dati v
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
tednov), pri starejš bolnikih s psihozo, povezano z demenco, in/ ali vedenjskimi motnjami ih
115 compared to patients treated with placebo (3.5% vs.
101 (povpreč starost 78 let), je bilo 2- krat več
116 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
aminotransferaze – ALT, aspartatne aminotransferaze – AST), posebno na zač zdravljenja.
117 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
anjih z olanzapinom so pri starejš bolnikih redko poroč o posturalni ih ali
118 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
104 Pri bolnikih, ki pijejo alkohol ali jemljejo zdravila, ki lahko povzroč depresijo osrednjega ž evja, je potrebna previdnost.
disorders
ane
Weight gain1
obč asno povezane s
Elevated cholesterol
glukoze4 zviš vrednosti
Development or
ketoacidozo ali komo,
119
ane
levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
smrtnimi primeri (gl. poglavje 4. 4)
exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
an
Nervous system disorders
hipotermija
Somnolence Cardiac disorders
epileptič napadi, ki ni
Dizziness Akathisia6 Parkinsonism6 Dyskinesia 6
parkinsonizem6 diskinezije6
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
e poroč ala nevroleptič maligni ni sindrom (gl. poglavje 4. 4) distonija (vključ z no okulogiracijo) tardivne diskinezije odtegnitveni simptomi7
Photosensitivity reaction Alopecia
106 Preiskave zmanjš plazemske
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions
zviš raven alkalne ana
120 Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
koncentracije prolaktina 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
valproatom in olanzapinom povzroč nevtropenije pri 4, 1% bolnikov; mož vzroč dejavnik so
121 valproate levels.
lahko poveč plazemske koncentracije valproata.
4.9 Overdose
108 4. 9 Preveliko odmerjanje
Signs and symptoms
ujejo delirij, konvulzije, komo,
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.
mož nevroleptič maligni sindrom, depresijo dihanja, aspiracijo, hipertenzijo ali hipotenzijo,
In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
109 Pri dveh od dveh s placebom kontroliranih in dveh od treh primerjalno kontroliranih preizkuš anjih na več 2900 bolnikih s shizofrenijo, ki so imeli tako pozitivne kot negativne simptome, je olanzapin kot statistič znač izboljš negativne in tudi pozitivne simptome.
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
V dvojno slepi primerjalni raziskavi shizofrenije ter shizoafektivnih in sorodnih motenj, v kateri je sodelovalo več av in skupaj 1481 bolnikov z različ
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).
simptomov (izhodišna srednja vrednost 16, 6 na Montgomery- Asbergovi lestvici ocenjevanja č depresije), je prospektivna sekundarna analiza spremembe od izhodišne do konč ocenene razpolož pokazala statistič znač izboljš (p = 0, 001) v korist olanzapina (– 6) v primerjavi
The predominant pharmacologic activity is from the parent olanzapine.
Po peroralnem dajanju se je srednji konč razpolovni č izloč olanzapina pri zdravih
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
a osebah razlikoval glede na starost in spol.
In 44
istek
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.
bolnikih s shizofrenijo, starejš od 65 let, odmerjanje od 5 do 20 mg/ dan ni pokazalo razlike v profilu ih než elenih učinkov.
Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Reverzibilni uč zaradi poveč koncentracije prolaktina so pri podganah povzroč zmanjš
Reversible
nosti za kostni
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).
Pri nekaj psih, ki so jim dajali 8 ali 10 mg/ kg na dan (celotna izpostavljenost olanzapinu je bila 12 - do 15- krat več kot pri č
6.6 Special precautions for disposal
112 6. 6 Posebni varnostni ukrepi za odstranjevanje
126 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, tovarna zdravil, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenija ka
Zalasta 15 mg orodispersible tablets
Zalasta 10 mg orodisperzibilne tablete
Each orodispersible tablet contains 15 mg olanzapine.
1 orodisperzibilna tableta vsebuje 10 mg olanzapina.
Each orodispersible tablet contains 1.50 mg aspartame.
Pomož snov: na 1 orodisperzibilna tableta vsebuje 1, 00 mg aspartama.
128 Olanzapine can be given without regards for meals as absorption is not affected by food.
114 Bolniki lahko jemljejo olanzapin ne glede na obroke, ker hrana ne vpliva na absorpcijo.
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.
tednov), pri starejš bolnikih s psihozo, povezano z demenco, in/ ali vedenjskimi motnjami ih
1.5%, respectively).
115 (povpreč starost 78 let), je bilo 2- krat več
Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e. g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Dejavniki tveganja, ki pri tej skupini bolnikov lahko vp livajo na več umrljivost, so jo starost več 65 let, tež s pož
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.
Hiperglikemija in diabetes Redko so poroč o hiperglikemiji in/ ali razvoju ali poslabš sladkorne bolezni, vključ z nekaj
8).
ali
130 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
aminotransferaze – ALT, aspartatne aminotransferaze – AST), posebno na zač zdravljenja.
131 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
anjih z olanzapinom so pri starejš bolnikih redko poroč o posturalni ih ali
132 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Terapevtsko spremljanje plazemskih koncentracij valproata ni pokazalo, da bi bilo treba po uvedbi sočasnega zdravljenja z olanzapinom prilagoditi odmerek valproata.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
118 Pri bolnikih, ki pijejo alkohol ali jemljejo zdravila, ki lahko povzroč depresijo osrednjega ž evja, je potrebna previdnost.
133 Metabolism and nutrition disorders Weight gain1
trigliceridov 2, 5 glikozurija poveč apetit
Photosensitivity reaction Alopecia
120 Preiskave zmanjš plazemske
134 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
koncentracije prolaktina 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.
valproatom in olanzapinom povzroč nevtropenije pri 4, 1% bolnikov; mož vzroč dejavnik so
4.9 Overdose
122 4. 9 Preveliko odmerjanje
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.
Znaki in simptomi Zelo pogosti simptomi pri prevelikem odmerjanju (incidenca > 10%) vključ ujejo tahikardijo, vznemirjenost/ nasilnost, dizartrijo, različ ekstrapiramidne simptome in motnje zavesti v razponu od ne sedacije do kome.
In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
123 Pri dveh od dveh s placebom kontroliranih in dveh od treh primerjalno kontroliranih preizkuš anjih na več 2900 bolnikih s shizofrenijo, ki so imeli tako pozitivne kot negativne simptome, je olanzapin kot statistič znač izboljš negativne in tudi pozitivne simptome.
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).
simptomov (izhodišna srednja vrednost 16, 6 na Montgomery- Asbergovi lestvici ocenjevanja č depresije), je prospektivna sekundarna analiza spremembe od izhodišne do konč ocenene razpolož pokazala statistič znač izboljš (p = 0, 001) v korist olanzapina (– 6) v primerjavi
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).
Pri zdravih starejš osebah (65 let in več je bil v primerjavi z mlajš osebami srednji razpolovni
139 Haematologic toxicity:
Hematološ toksič
6.6 Special precautions for disposal
126 6. 6 Posebni varnostni ukrepi za odstranjevanje
141 1.
127 1.
Zalasta 20 mg orodispersible tablets
Zalasta 15 mg orodisperzibilne tablete
Each orodispersible tablet contains 20 mg olanzapine.
1 orodisperzibilna tableta vsebuje 15 mg olanzapina.
Each orodispersible tablet contains 2.00 mg aspartame.
Pomož snov: na 1 orodisperzibilna tableta vsebuje 1, 50 mg aspartama.
142 Olanzapine can be given without regards for meals as absorption is not affected by food.
128 Bolniki lahko jemljejo olanzapin ne glede na obroke, ker hrana ne vpliva na absorpcijo.
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.
otrocih in mladostnikih, mlajš od 18 let.
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed
tednov), pri starejš bolnikih s psihozo, povezano z demenco, in/ ali vedenjskimi motnjami ih
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.
129 (povpreč starost 78 let), je bilo 2- krat več
144 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
aminotransferaze – ALT, aspartatne aminotransferaze – AST), posebno na zač zdravljenja.
145 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
anjih z olanzapinom so pri starejš bolnikih redko poroč o posturalni ih ali
146 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
132 Pri bolnikih, ki pijejo alkohol ali jemljejo zdravila, ki lahko povzroč depresijo osrednjega ž evja, je potrebna previdnost.
147
ane
Dizziness Akathisia6 Parkinsonism6 Dyskinesia 6
parkinsonizem6 d
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
poroč ala nevroleptič maligni ni sindrom (gl. poglavje 4. 4) distonija (vključ z no okulogiracijo) tardivne diskinezije odtegnitveni simptomi7
Photosensitivity reaction Alopecia
134 Preiskave zmanjš plazemske
148 Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
koncentracije prolaktina 8
149 valproate levels.
lahko poveč plazemske koncentracije valproata.
4.9 Overdose
136 4. 9 Preveliko odmerjanje
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.
mož nevroleptič maligni sindrom, depresijo dihanja, aspiracijo, hipertenzijo ali hipotenzijo,
In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
137 Pri dveh od dveh s placebom kontroliranih in dveh od treh primerjalno kontroliranih preizkuš anjih na več 2900 bolnikih s shizofrenijo, ki so imeli tako pozitivne kot negativne simptome, je olanzapin kot statistič znač izboljš negativne in tudi pozitivne simptome.
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).
simptomov (izhodišna srednja vrednost 16, 6 na Montgomery- Asbergovi lestvici ocenjevanja č depresije), je prospektivna sekundarna analiza spremembe od izhodišne do konč ocenene razpolož pokazala statistič znač izboljš (p = 0, 001) v korist olanzapina (– 6) v primerjavi
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
č izloč podaljš (51, 8 v primerjavi s 33, 8 ure), oč as
In 44
(17, 5 v primerjavi z an
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.
bolnikih s shizofrenijo, starejš od 65 let, odmerjanje od 5 do 20 mg/ dan ni pokazalo razlike v profilu ih než elenih učinkov.
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).
Pri nekaj psih, ki so jim dajali 8 ali 10 mg/ kg na dan (celotna izpostavljenost olanzapinu je bila 12 - do 15- krat več kot pri č
6.6 Special precautions for disposal
140 6. 6 Posebni varnostni ukrepi za odstranjevanje
154 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, tovarna zdravil, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenija ka
155 ANNEX II
IME ZDRAVILA
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Pomož snov: na 1 orodisperzibilna tableta vsebuje 2, 00 mg aspartama.
B.
lo
CONDITIONS OF THE MARKETING AUTHORISATION
Pri bolnikih, ki so jemali olanzapin za zdravljenje
156 A.
etni
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
manič epizode, nadaljujte zdravljenje z enakim odmerkom olanzapina za prepreč
Name and address of the manufacturers responsible for batch release
Č se pojavi nova manič meš ali depresivna epizoda, je treba zdravljenje z
KRKA, d. d., Novo mesto Š marješ cesta 6, 8501 Novo mesto ka Slovenia
Med zdravljenjem shizofrenije in manič epizode in med prepreč
KRKA Polska Sp. z o. o.
Več poveč od priporoč
Ul.
je
Równoległ 5, Warszawa a Poland
anje
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.
enega začetnega odmerka priporoč le po ponovni klinič amo
B.
ni
CONDITIONS OF THE MARKETING AUTHORISATION
Pred ponovnim poveč anjem odmerka mora miniti najmanj 24 ur.
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Ker se v slini hitro razpusti, jo je mogoč
Medicinal product subject to medical prescription.
Ker je krhka, jo je treba dati v
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Lahko pa jo neposredno pred zauž itjem razpusti v kozarcu, polnem vode ali druge ustrezne pijač (npr. pomaranč
Not aplicable.
Odmerjanje je enako, prav tako pogostost jemanja.
 OTHER CONDITIONS
inkovitosti olanzapina ne priporoč za uporabo pri amo
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.
V kratkotrajnih raziskavah na bolnih mladostnikih so ih poroč o več poveč telesne mase in o spremenjenih vrednostih lipidov in prolaktina kot v
PSURs The PSUR submission schedule for Zalasta tablets and orodispersible tablets should follow PSURs submission schedule for the reference medicinal product.
raziskavah na bolnih odraslih (gl. poglavja 4. 4, 4. 8, 5. 1 in 5. 2).
157 ANNEX III
Starejšbolniki i Z manjš zač
LABELLING AND PACKAGE LEAFLET
Bolnike z zmerno okvarjenim jetrnim
158 A.
nite
LABELLING
imi
159 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Č je prisoten več en dejavnik, ki bi lahko prispeval k poč
CARTON FOR ZALASTA 2.5 mg TABLETS
asnejšpresnovi (ž i enski spol, starostnik,
1.
ati
NAME OF THE MEDICINAL PRODUCT
evanju odmerka, kadar je to
Zalasta 2.5 mg tablets Olanzapine
Bolnikom, ki jim boste odmerek poveč evali po 2, 5 mg, predpiš tablete Zalasta. ite
STATEMENT OF ACTIVE SUBSTANCE(S)
(gl. poglavji 4. 5 in 5. 2).
3.
4. 3 Kontraindikacije
LIST OF EXCIPIENTS
4. 4 Posebna opozorila in previdnostni ukrepi
Contains lactose monohydrate.
Med zdravljenjem z antipsihotiki je treba bolnike skrbno opazovati.
See package leaflet for further information.
ganskož dogodke ni priporoč za ilne
4.
en
PHARMACEUTICAL FORM AND CONTENTS
anjih, kontroliranih s placebom (ki so trajali 6 do 12
14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
143 (povpreč starost 78 let), je bilo 2- krat več
5.
na
METHOD AND ROUTE(S) OF ADMINISTRATION
smrtnih primerov med bolniki, zdravljenimi z
Read the package leaflet before use.
olanzapinom, kot med bolniki, zdravljenimi s placebom (3, 5% v primerjavi z 1, 5%).
Oral use.
Več smrtnost ja ni bila povezana z odmerkom olanzapina (povpreč dnevni odmerek je bil 4, 4 mg) ali trajanjem ni zdravljenja.
6.
ave
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
iranjem, sedacija, nezadostna prehrana ali dehidracija, pljuč na
Keep out of the reach and sight of children.
obolenja (npr. pljuč z aspiracijo ali brez nje) ali soč
7.
nica
OTHER SPECIAL WARNING(S), IF NECESSARY
Vendar je bila
8.
nih
EXPIRY DATE
anjih so poroč o mož
EXP:
ali
9.
ganskož