qanastek/EMEA-V3 huggingface dataset:
Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Tuż adrenalina, dopamina jew sustanzi oħ simpatomimetiċb' attività
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta- agonist activity since beta stimulation may worsen hypotension.
Għ
Cardiovascular monitoring is necessary to detect possible arrhythmias.
kardjovaskulari biex jintgħ r- ritmi abnormali li jista 'jkun hemm.
Close medical supervision and monitoring should continue until the patient recovers.
medika stretta għ andha titkompla sakemm jirkupra l- pazjent.
5.1 Pharmacodynamic properties
5. 1 Tagħ farmakodinamiku rif
Pharmacotherapeutic group: antipsychotics: diazepines, oxazepines and thiazepines, ATC code:
Kategorija farmakoterapewtika: antipsikotiċ diazepines, oxazepines u thiazepines, kodiċATC:
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Olanzapine hu sustanza antipsikotika, antimanijaka u li tistabbilizza l- burdata li turi profil farmakoloġiku wiesa 'f' diversi sistemi ta' riċ etturi.
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.
għ as- serotonin 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamina D1, D2, D3, D4, D5; riċ koliner ġ i m1- m5; α adrenerġ i; u riċ
Animal behavioral studies with 1 olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor- binding profile.
1 iċ
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Saru studji elettrofiż iċli wrew li olanzapine joloġ i naqqas selettivament l- istimulazzjoni tan- newroni dopaminerġ i meż
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
effett fuq l- istriatal (A9) pathways li għ andhom x' jaqsmu mal- funzjoni tal- moviment.
Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Olanzapine naqqas rispons magħ bħ conditioned avoidance, test li juri l- preż
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
Għ “ tat- tnaqqis tat- tensjoni ”.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
tomography (PET) ta 'doż orali waħ a danija (10 mg) f' voluntiera
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.
jirrispondu għ olanzapine kellhom striatal D2 occupancy iktar baxxa minn xi pazjenti oħ li jirrispondu
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.
Fi studju multinazzjonali double- blind komparattiv ta 'l- iskiż ofrenija, mard skiż oaffettiv u mard ieħor relatat li fih ħ sehem 1, 481 pazjent bi gradi varji ta' sintomi dipressivi assoċ (medja bażta '16. 6 fuq
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).
l- iskala tad- dipressjoni Montgomery- Asberg), saret analiżsekondarja prospettiva tat- tibdil fil- punteġ tal - i ħ burdati mill- bażsa l- aħar u din uriet li kien hemm titjib statistikament sinjifikant (p=0. 001) favur i olanzapine (- 6. 0) meta mqabbel ma 'haloperidol (- 3. 1).
In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
plaċ u għ valproate semisodium (divalproex) fit- tnaqqis tas- sintomi manijaċfuq perjodu ta '3
Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
ultati ta 'l- effikaċ komparabbli għ haloperidol f' termini tal - ja al ad- dipressjoni wara 6 ġ at u 12- il
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition
ġimgħ Fi studju tal- ko- terapija ta 'pazjenti ttrattati bil- litju jew b’ valproate għ minimu ta' ġ
11 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.
12 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
Fi studju tal- prevenzjoni tar- rikorrenza li dam 12- il xahar f' pazjenti b' episodji manijaċli kellhom i remissjoni fuq olanzapine u li mbagħ tqassmu b’ mod każ fil- grupp ta 'olanzapine u ieħ tal -
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recur rence into mania or recurrence into depression.
Olanzapine wera wkoll vantaġ tal- prevenzjoni tar- rikorrenza tal- manija jew tar- rikorrenza tad- dipressjoni.
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
il- punt finali primarju tar- rikorrenza bipolari (olanzapine 30. 0%, litju 38. 3%; p = 0. 055).
In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
flimkien ma 'stabilizzatur tal- burdata (litju jew valproate), il- ko- terapija fit- tul ta' olanzapine mal- litju jew valproate ma kinitx superjuri b' mod statistikament sinjifikanti għ
Paediatric population The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
rikorrenzabipolari, definita skond il- kriterji (dijanjostiċ tas- sindromu. i)
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
Id- doż ta ’ Olanzapine ma kienitx fissa u bdiet b' 2. 5 u telgħ sa 20
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Waqt il- kura b' olanzapine, l- adolexxenti ż aktar fil- piż mg/ ġ
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
M' hemmx tagħ dwar il - rif manteniment ta 'l- effett u hemm tagħ limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8). rif
5.2 Pharmacokinetic properties
5. 2 Tagħ farmakokinetiku rif
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
wara bejn 5 u 8 sigħ L- assorbiment ma jiġ affettwat mill- ikel.
The absorption is not affected by food.
Il- bijodisponibilità orali assoluta
Absolute oral bioavailability relative to intravenous administration has not been determined.
mqabbla ma 'l- għ fil- vina ma ġ determinata.
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Olanzapine jiġ metabolizzat fil- fwied permezz ta 'sekwenzi ta' reazzjonijiet konjugattivi u ossidattivi.
The major circulating metabolite is the 1 0-N-glucuronide, which does not pass the blood brain barrier.
Il - i metabolit ewlieni fiċ irkulazzjoni hu l- 1 0- N- glucuronide, li ma jgħ
Cytochromes P450- CYP 1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
ċitokromi P450- CYP 1A2 u P450- CYP2D6 jikkontribwixxu għ and 2- hydroxymethyl, u t- tnejn li huma wrew attività farmakoloġ
The predominant pharmacologic activity is from the parent olanzapine.
L- attività farmakoloġ predominanti hi mill - olanzapine ika oriġ inali.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Wara li jingħ oralment, il - half- life ta 'l - eliminazzjoni terminali medja ta' ata ħ olanzapine f' persuni b' saħithom varjat skond l- età u s- sess.
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).
ħ Meta tqabblu anzjani (ta '65 sena jew iktar) f' saħithom ma' persuni mhux anzjani, il - half- life ta 'l - ħ eliminazzjoni terminali medja ttawlet (51. 8 u 33. 8 siegħ rispettivament) u r- rata ta' tneħija tnaqqset a (17. 5 u 18. 2 litru fis- siegħ rispettivament).
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
F' 44 pazjent bl- iskiż
In 44 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
ofrenija ta 'iktar minn 65 sena, dożta' bejn 5 u 20 i
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).
Meta tqabblu n- nisa ma 'l- irġ il- half- life ta' l- eliminazzjoni terminali medja kienet ftit jew iel, ħ wisq itwal fin - nisa (36. 7 siegħ u 32. 3 siegħ rispettivament) u r- rata ta 'tneħija tnaqqset (18. 9 u 27. 3
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Madankollu, olanzapine (5- 20 mg) wera profil ta 'sigurtà komparabbli fil - a pazjenti nisa (n=467) u fil- pazjenti rġ (n=869). iel
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).
13 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
tal- massa li wera li madwar 57% ta 'olanzapine radjutikkettat
12 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).
F' persuni jpejpu bi problemi ħ tal- fwied, il - half- life ta 'l - eliminazzjoni terminali medja (39. 3 fief ħ siegħ kienet itwal u r - rata ta' tneħ ija (18. 0- il litru fis- siegħ tnaqqset meta mqabbla ma 'persuni
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
Meta tqabblu rġ u nisa jpejpu ma 'dawk li ma jpejpux, il- half - life ta' l- eliminazzjoni terminali iel ħ medja kienet itwal (38. 6 siegħ u 30. 4 siegħ rispettivament) u r- rata ta 'tneħija tnaqqset (18. 6 u 27. 7 litru fis- siegħ rispettivament). a
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Ir- rata ta 'tneħija ta' olanzapine mill- plaż hi iktar baxxa fl- anzjani meta mqabbla ma 'persuni iż ar,
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
fin- nisa meta mqabbla ma 'l- irġ u fil- persuni li ma jpejpux meta mqabbla ma' dawk li jpejpu. iel, ħ Madankollu, l- impatt ta 'l- età, tas- sess, u tat- tipjip fuq ir- rata ta' tneħija ta 'olanzapine u fuq il- half- life hu ż ir meta mqabbel mal- varjabilità globali bejn l- individwi. għ
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Fi studju ta 'persuni ta' razza Kawkasa, Ġappuniżu Ċ i, ma kienx hemm differenzi fil- parametri farmakokinetiċbejn it- tliet popolazzjonijiet. i
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
ta 'bejn madwar 7 u madwar 1000 ng/ ml.
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
Olanzapine jeħ predominantement ma 'l- albumina u ma' α - acid- glycoprotein.
Paediatric population Adolescents (ages 13 to 17 years):
Adolexxenti (minn 13 sa 17- il sena):
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
izzjoni għ olanzapine kienet bejn wieħ u ieħ ta '27% ogħ al ed or
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Id- differenzi demografiċbejn l- adolexxenti u l- adulti jinkludu medja anqas ta 'piż
Such factors possibly contribute to the higher average exposure observed in adolescents.
Fatturi bħ dawn x' aktarx li jikkontribwixxu għ espoż izzjoni ogħ osservata fl- adolexxenti. la
5.3 Preclinical safety data
Effett tossiku akut (minn doż waħ
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Fl- annimali gerriema, is- sinjali ta ’ tossiċ orali kienu karatteristiċta 'komposti newrolettiċpotenti:
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Il- klieb
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Is- sinjali kliniċkienu jinkludu ajr i
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Fix- xadini, dożwaħ
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
danin sa 100 mg/ kg wasslu għ prostrazzjoni u, f' dożikbar, al
Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Ġ ż
Tolerance developed to the CNS depression.
ad- dipressjoni tas- sistema nervuż ċ
Growth parameters were decreased at high doses.
Il- parametri tat- tkabbir tnaqqsu
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.
f' dożgħ L- effetti riversibbli konsistenti ma 'livell elevat ta' prolactin fil- firien kienu jinkludu i olja. tnaqqis fit- toqol ta 'l- ovarji u ta' l- utru u tibdiliet morfoloġ i fl- epitilju vaġ
Haematologic toxicity:
ġ rieden u tnaqqis mhux speċ
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
fil- firien; madankollu ma nstabet ebda evidenza ta 'effett iti
Reversible 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).
Fi klieb ċ
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
hemm effetti ħiena fuq iċ elloli proliferanti u progenitor fil- mudullun.
Reproductive toxicity Olanzapine had no teratogenic effects.
Effett tossiku fuq is- sistema riproduttiva Olanzapine ma kellux effetti teratoġ i.
Sedation affected mating performance of male rats.
Is- sedazzjoni affettwat il- prestazzjoni tat- tgħ
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
Fil- frieħtal- firien li ngħ
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
Effett tossiku fuq il- ġ eni Olanzapine ma kellux effett tossiku fuq il- ġ f' varjetà sħ a ta 'testijiet, li kienu jinkludu testijiet ta'
13 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.
mutazzjonijiet batteriċu testijiet tal- mammiferi in vitro u in vivo. i
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Riskju ta ’ kanċ er rieden u fil- firien, ġ konkluż olanzapine ma jż ir- riskju ta ’ Skond ir- riż ultati ta 'l- istudji fil- ġ kanċ er.
6.
li
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
This medicinal product does not require any special storage conditions.
Ż 6. 3 mien kemm idum tajjeb il- prodott mediċ inali
6.5 Nature and contents of container
andhiex bż ħ na speċ Din il- mediċ m’ għ
Blister pack (OPA/ Al/ PVC, Al-foil):
Pakkett ta ’ folji (OPA/ Al/ PVC, Al- foil):
14, 28, 35, 56 or 70 tablets in a box.
14, 28, 35, 56 jew 70 pillola f' kaxxa.
6.6 Special precautions for disposal
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għ skop kummerċ
Any unused product or waste material should be disposed of in accordance with local requirements.
al
7.
jali.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
6. 6
MARKETING AUTHORISATION NUMBER(S)
Prekawzjonijiet speċ li għ
9.
jali
DATE OF REVISION OF THE TEXT
andhom jittieħ meta jintrema du
15 1.
15
Zalasta 5 mg tablets
Zalasta 5 mg pilloli
Each tablet contains 5 mg olanzapine.
Kull pillola fiha 5 mg olanzapine.
Each tablet contains 80.9 mg lactose.
Kull pillola fiha 80. 9 mg lactose.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 5”.
Il- pilloli huma tondi, xi ftit konvessi, jagħ fl- isfar possibbilment b' tikek sofor individwali u bl - tu iskrizzjoni “ 5 ”.
If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
ottima kif meħ), b' terapija supplimentari għ klinikament.
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5- 20 mg/ day.
Id - i andhiex tiż għ waħ ikbar mid- doż inizjali rakkomandata ħ jekk issir valutazzjoni doż m' għ
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
klinika xierqa mill- ġ u mhux iktar spiss minn kull 24 siegħ
16 Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
Gradual tapering of the dose should be considered when discontinuing olanzapine.
Meta jkun sa jitwaqqaf it- trattament, wieħ għed andu jikkunsidra t- tnaqqis tad- doż bil- mod il- mod. a
Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċ Fl- istudji ta ’ terminu qasir, ġ rrapportat ammont akbar ta ’ ż fil- piż tibdil fix- xaħ
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).
Anzjani Doż inizjali iktar baxxa (5 mg kuljum) mhix indikata bħ rutina iż għ
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Waqt trattament bl- antipsikotiċ titjib fil- kundizzjoni klinika tal- pazjent għ
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 compared to patients treated with placebo (3.5% vs.
), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożrelatata mad - a i
1.5%, respectively).
L- inċ
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
kuljum ta ’ 4. 4 mg) jew it- tul ta ’ ż mien tat- trattament.
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.
Il- fatturi ta ’ riskju li jistgħ jippredisponu dan il - u grupp ta ’ pazjenti għ ż fil- mortalità jinkludu l- età ta ’ > 65 sena, id- diffikulta biex wieħ jibla ’, is -
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Madankollu, l- inċ
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
attakki iskemiċmomentanji) inklużl- imwiet.
There was a 3-fold increase in CVAE in patients treated
Kien hemm ż ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti
17 with olanzapine compared to patients treated with placebo (1.3% vs.
ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċ (1. 3% kontra 0. 4U%, rispettivament). ebo Il- pazjenti kollha ttrattati b' olanzapine jew bi plaċ u li kellhom avveniment ċ
0.4%, respectively).
erebro- vaskulari, kellhom
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
fatturi ta ’ riskju li kienu jeż minn qabel.
18 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.
ikkawż minn mard kontemporanju, terapija bir- radjazzjoni jew kimoterapija u f' pazjenti ata b' kundizzjonijiet iperesinofiliċjew b' mard mijeloproliferattiv.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
20 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
19 Lactose Zalasta tablets contain lactose.
Il- pilloli Zalasta jkun fihom il- lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Il- pazjenti bi problemi ereditarji rari ta 'intolleranza għall- galactose, defiċ jenza ta ’ Lapp lactase jew nuqqas ta' assorbiment tal- glukoż mediċ ina.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħ li ma jaqblux ma ’ dan il- prodott u affarijiet oħ li jistgħ jibdlu l -
Interaction studies have only been performed in adults.
Studji dwar l- effett ta ’ mediċ jew ta ’ affarijiet oħ fuq l- effett farmaċ biss.
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.
Interazzjonijiet potenzjali li jaffettwaw olanzapine Billi olanzapine jiġmetabolizzat bis- CYP1A2, sustanzi li speċ
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Induzzjoni ta 'CYP1A2 Il- metaboliż ta' olanzapine jista 'jiġindott mit- tipjip u minn carbamazepine, li jista' jwassal għ
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
21 Ma ntweriex li l- farmakokinetika ta 'olanzapine tiġ affettwata minn fluoxetine (inibitur tas- CYP2D6), i dożwaħ i danin ta' sustanzi kontra l- aċ (aluminju, manjeż jew cimetidine.
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
(ara sezzjoni 4. 4) Ipotermija
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Mass Index - BMI), fil- kategoriji kollha.
Weight gain ≥ 7% of baseline body weight was very common and ≥
Żieda fil- piż ≥7% mil- linja bażtal- piż
22
la
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
24 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
23 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Għ imwettqa studji kliniċmagħ
11 Common:
Komuni:
Elevated cholesterol levels Nervous system disorders Very common:
Livelli għ ta 'kolesterol11 olja Disturbi fis- sistema nervuż
24 Management of overdose There is no specific antidote for olanzapine.
iċ Il- ġestjoni ta 'dożeċessivi Ma hemm l- ebda antidotu speċ għ olanzapine.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Saru studji elettrofiż iċli wrew li olanzapine joloġ i naqqas selettivament l- istimulazzjoni tan- newroni dopaminerġ i meż iċ
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
effett fuq l- istriatal (A9) pathways li għandhom x' jaqsmu mal- funzjoni tal- moviment.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
Fi studju bil- Positron Emission tomography (PET) ta 'doż orali waħ
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.
27 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
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).
28 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
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).
F' persuni jpejpu bi problemi ħ tal- fwied, il - half- life ta 'l - eliminazzjoni terminali medja (39. 3 fief ħ siegħ kienet itwal u r - rata ta' tneħ ija (18. 0- il litru fis- siegħ tnaqqset meta mqabbla ma 'persuni
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.
mutazzjonijiet batteriċu testijiet tal- mammiferi in vitro u in vivo. i
6.3 Shelf life
Ż 6. 3 mien kemm idum tajjeb il- prodott mediċ inali
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċ għ aż jali all- ħ na
This medicinal product does not require any special storage conditions.
andhiex bż ħ na speċ Din il- mediċ m’ għ
6.5 Nature and contents of container
In- natura tal- kontenitur u ta ’ dak li hemm ġ fih 6. 5 o
Blister pack (OPA/ Al/ PVC, Al-foil):
Pakkett ta’ folji (OPA/ Al/ PVC, Al- foil):
Not all pack sizes may be marketed.
Prekawzjonijiet speċ li għ
6.6 Special precautions for disposal
andhom jittieħ meta jintrema du
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuż jew skart li jibqa ’ wara l- uż tal- prodott għ jitolbu l- liġ lokali. ijiet
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, Slovenja ka
27 September 2007.
27 ta ’ Settembru 2007.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġ enzija Ewropea dwar il- Mediċ ini (EMEA) http: // www. emea. europa. eu
Zalasta 7.5 mg tablets
Zalasta 7. 5 mg pilloli
Each tablet contains 7.5 mg olanzapine.
Kull pillola fiha 7. 5 mg olanzapine.
Each tablet contains 121.3 mg lactose.
Kull pillola fiha 121. 3 mg lactose.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 7.5”.
Il- pilloli huma tondi, xi ftit konvessi, jagħ fl- isfar possibbilment b' tikek sofor individwali u bl - tu iskrizzjoni “ 7. 5 ”.
30 Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
31 with olanzapine compared to patients treated with placebo (1.3% vs.
ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċ (1. 3% kontra 0. 4U%, rispettivament). ebo Il- pazjenti kollha ttrattati b' olanzapine jew bi plaċ u li kellhom avveniment ċ
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.
ikkawż minn mard kontemporanju, terapija bir- radjazzjoni jew kimoterapija u f' pazjenti ata b' kundizzjonijiet iperesinofiliċjew b' mard mijeloproliferattiv.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
35 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical tria ls.
Il- pressjoni baxxa relatata mat- tibdil tal- poż izzjoni kienet osservata mhux frekwentement fl- anzjani fi studji kliniċb' olanzapine.
33 Lactose Zalasta tablets contain lactose.
Il- pilloli Zalasta jkun fihom il- lactose.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
36 Ma ntweriex li l- farmakokinetika ta 'olanzapine tiġ affettwata minn fluoxetine (inibitur tas- CYP2D6), i dożwaħ i danin ta' sustanzi kontra l- aċ (aluminju, manjeż jew cimetidine.
36
la
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
39 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
37 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Għ imwettqa studji kliniċmagħ
38 Management of overdose There is no specific antidote for olanzapine.
iċ Il- ġestjoni ta 'dożeċessivi Ma hemm l- ebda antidotu speċ għ olanzapine.
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.
42 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
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).
43 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
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).
F' persuni jpejpu bi problemi ħ tal- fwied, il - half- life ta 'l - eliminazzjoni terminali medja (39. 3 fief ħ siegħ kienet itwal u r - rata ta' tneħ ija (18. 0- il litru fis- siegħ tnaqqset meta mqabbla ma 'persuni
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.
mutazzjonijiet batteriċu testijiet tal- mammiferi in vitro u in vivo. i
Zalasta 10 mg tablets
Zalasta 10 mg pilloli
Each tablet contains 10 mg olanzapine.
Kull pillola fiha 10 mg olanzapine.
Each tablet contains 161.8 mg lactose.
Kull pillola fiha 161. 8 mg lactose.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 10”.
Il- pilloli huma tondi, xi ftit konvessi, jagħ fl- isfar possibbilment b' tikek sofor individwali u bl - tu iskrizzjoni “ 10 ”.
44 Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
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.
li jista 'jnaqqas il- metaboliż (pazjenti nisa, pazjenti anzjani,
45 with olanzapine compared to patients treated with placebo (1.3% vs.
ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċ (1. 3% kontra 0. 4U%, rispettivament). ebo Il- pazjenti kollha ttrattati b' olanzapine jew bi plaċ u li kellhom avveniment ċ
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Meta olanzapine wera attività antikolinerġ in vitro, l- esperjenza waqt l - istudji kliniċ wriet
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Madankollu billi l- esperjenza klinika ma 'olanzapine
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.
ikkawż minn mard kontemporanju, terapija bir- radjazzjoni jew kimoterapija u f' pazjenti ata b' kundizzjonijiet iperesinofiliċjew b' mard mijeloproliferattiv.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
50 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
47 Lactose Zalasta tablets contain lactose.
Il- pilloli Zalasta jkun fihom il- lactose.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
51 Ma ntweriex li l- farmakokinetika ta 'olanzapine tiġ affettwata minn fluoxetine (inibitur tas- CYP2D6), i dożwaħ i danin ta' sustanzi kontra l- aċ (aluminju, manjeż jew cimetidine.
50
la
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
54 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
51 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Għ imwettqa studji kliniċmagħ
52 Management of overdose There is no specific antidote for olanzapine.
iċ Il- ġestjoni ta 'dożeċessivi Ma hemm l- ebda antidotu speċ għ olanzapine.
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.
57 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
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).
58 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
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).
F' persuni jpejpu bi problemi ħ tal- fwied, il - half- life ta 'l - eliminazzjoni terminali medja (39. 3 fief ħ siegħ kienet itwal u r - rata ta' tneħ ija (18. 0- il litru fis- siegħ tnaqqset meta mqabbla ma 'persuni
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.
mutazzjonijiet batteriċu testijiet tal- mammiferi in vitro u in vivo. i
7, 14, 28, 35, 56 or 70 tablets in a box.
7, 14, 28, 35, 56 jew 70 pillola f' kaxxa.
Zalasta 15 mg tablets
Zalasta 15 mg pilloli
Each tablet contains 15 mg olanzapine.
Kull pillola fiha 15 mg olanzapine.
Each tablet contains 242.7 mg lactose.
Kull pillola fiha 242. 7 mg lactose.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 15”.
Il- pilloli huma tondi, xi ftit konvessi, jagħ fl- isfar possibbilment b' tikek sofor individwali u bl - tu iskrizzjoni “ 15 ”.
The recommended starting dose is 10 mg/ day.
Id- doż inizjali rrakkomandata hi ta ’ 10 mg kuljum.
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Għ
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5- 20 mg/ day.
a
58 Olanzapine can be given without regards for meals as absorption is not affected by food.
al
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).
Jekk ikun hemm episodju ġ ta 'manija,
Elderly A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see also section 4.4).
a
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
did ġ
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
dipressjoni jew taħ tat- tnejn, it- trattament b' olanzapine għ
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
lita
Dose escalation, when indicated, should be conservative in such patients.
andu jitkompla (b’ aġustament għ doż
(See sections 4.5 and 5.2.)
al
4.3 Contraindications
a
Hypersensitivity to the active substance or to any of the excipients.
ottima kif meħ), b' terapija supplimentari għ klinikament.
Patients with known risk for narrow-angle glaucoma.
at- trattament tas- sintomi tal- burdata, kif indikat
4.4 Special warnings and precautions for use
62 Waqt it- trattament għ
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
all- iskiż ofrenija, episodji ta 'manija u l- prevenzjoni ta' disturbi bipolari, id- doż ta 'a ġ
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
kuljum tista 'tiġ sussegwentement aġustata skond l- istat kliniku individwali bejn 5 u 20 mg kuljum.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Id - i andhiex tiż għ waħ ikbar mid- doż inizjali rakkomandata ħ jekk issir valutazzjoni doż m' għ
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
a
0.4%, respectively).
died al
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
da
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
a died al da a
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
lief
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
klinika xierqa mill- ġ u mhux iktar spiss minn kull 24 siegħ
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
did
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
a.
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
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.
ed
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when olanzapine is stopped abruptly.
ax
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
u
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
ix
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Meta jkun sa jitwaqqaf it- trattament, wieħ għed andu jikkunsidra t- tnaqqis tad- doż bil- mod il- mod. a
Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Tfal u adolexxenti Olanzapine mhux irrakkomandat għ
Seizures have been reported to occur rarely in patients when treated with olanzapine.
all- uż
In most of these cases, a history of seizures or risk factors for seizures was reported.
fit- tfal u fl- adolexxenti ta ’ taħit- 18- il sena peress li u t
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċ Fl- istudji ta ’ terminu qasir, ġ rrapportat ammont akbar ta ’ ż fil- piż tibdil fix- xaħ
However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
ieda
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical tria ls.
u
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
mijiet u prolactin f’ pazjenti adolexxenti milli fl- istudji ta ’ pazjenti
61 Lactose Zalasta tablets contain lactose.
adulti (ara sezzjonijiet 4. 4, 4. 8, 5. 1 u 5. 2).
4.5 Interaction with other medicinal products and other forms of interaction
Anzjani Doż inizjali iktar baxxa (5 mg kuljum) mhix indikata bħ rutina iż għ
Interaction studies have only been performed in adults.
a
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.
ala
Only slight to moderate increase in olanzapine clearance has been observed.
da andha tkun ikkunsidrata għ al