qanastek/EMEA-V3 huggingface dataset:
The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
dawk li jkollhom 65 sena jew iktar meta xi fatturi kliniċjitolbu dan (ara wkoll sezzjoni 4. 4). i
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Indeboliment renali u/ jew epatiku Għ dawn il- pazjenti għ al andha tkun ikkunsidrata doż inizjali iktar baxxa (5 mg).
The mean increase in olanzapine AUC was 52% and 108% respectively.
F' każ ta 'insuffiċ
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
a
Decreased bioavailability Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
ijiet
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
jenza epatika moderata (ċ i, Child- Pugh Klassi A jew B), id- doż inizjali għ mg u tiż biss b' kawtela. died
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
a
1A2, 2D6, 2C9, 2C19, 3A4).
andha tkun ta '5
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Sess
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Id- doż inizjali u l- limiti tad- doż m' għ
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
a a
CNS medicinal products Caution should be exercised in patients who receive medicinal products that can cause central nervous system depression and alcohol.
andhomx jinbidlu skond jekk il- pazjenti jkunux irġ jew nisa. iel
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Dawk
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
li jpejpu
62 4.6 Pregnancy and lactation
Id- doż inizjali u l- limiti tad- doż m' għ
Pregnancy:
a a
There are no adequate and well-controlled studies in pregnant women.
andhomx jinbidlu skond jekk il- pazjenti jkunux ipejpu.
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.
Meta
Lactation:
jkun hemm iktar minn fattur wieħ
In a study in lactating, healthy women, olanzapine was excreted in breast milk.
li jista 'jnaqqas il- metaboliż (pazjenti nisa, pazjenti anzjani,
4.7 Effects on ability to drive and use machines
pazjenti li ma jpejpux), wieħ għ
No studies on the effects on the ability to drive and use machines have been performed.
ed andu jikkunsidra li jnaqqas id- doż inizjali.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Għ dawn il- pazjenti, meta jkun indikat, id- doż għ a andha tiż b' moderazzjoni. died
4.8 Undesirable effects
(Ara sezzjonijiet 4. 5 u 5. 2.)
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
4. 3 Kontra- indikazzjonijiet
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
ċ Sensittività eċessiva għ as- sustanza attiva jew għ xi sustanzi mhux attivi. al
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Pazjenti b' riskju magħ għ ruf all- glawkoma.
The frequency terms listed are defined as follows:
4. 4 Twissijiet speċ u prekawzjonijiet għ
Very common (≥
all- uż u
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
Waqt trattament bl- antipsikotiċ titjib fil- kundizzjoni klinika tal- pazjent għ
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
i,
Very common
andu mnejn isir fuq medda ta ’
Common
al
Uncommon
at.
Not known
andhom jiġ monitorjati sew waqt dan il- perjodu. u
Blood and the lymphatic system disorders Immune system disorders
Psikożrelatata mad- demenzja u/ jew disturbi fil- komportament i Olanzapine mhux approvat għ
Eosinophilia
at- trattament tal- psikoż
Leukopenia Neutropenia
relatata mad- demenzja u/ jew disturbi fil - i
Thrombocytopenia Allergic reaction
all- uż f’ dan il- grupp partikolari ta ’ pazjenti, dovut għ ż komportament,
Metabolism and nutrition
u mhux irrakkomandat għ u ident ċ
disorders
al ieda
Weight gain1
Fi studji kliniċ
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
kkontrollati bil- plaċ (li damu i ebo
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
minn 6 sa 12- il ġ imgħ), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożrelatata mad -
Nervous system disorders Somnolence
demenzja u/ jew disturbi fil- komportament, kien hemm ż ta ’ darbtejn akbar fl- inċ
Dizziness Akathisia6
idenza ta ’ mwiet fil -
Seizures where in most cases a history of
idenza ogħ ta ’ l- imwiet ma kienitx assoċ mad- doż ta ’ olanzapine (doż medja la jata a
Cardiac disorders
al ieda
Parkinsonism6 Dyskinesia 6
ed
seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
sedazzjoni, il- malnutriment u d- deidrazzjoni, kundizzjonijiet tal- pulmun (eż
Vascular disorders
pulmonite, bil - jew fl- assenza
Bradycardia QT c prolongation (see section 4.4)
ta ’ l- aspirazzjoni), jew l- uż konkomittanti ta 'benzodiazepines.
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
u
Orthostatic hypotension
idenza ta ’ l- imwiet
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
kienet ogħ f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil- plaċ indipendentement
Gastrointestinal disorders
minn dawn il- fatturi ta ’ riskju.
Mild, transient anticholinergic effects including constipation and dry mouth
Fl- istess studji kliniċ kienu rrapportati avvenimenti avversi ċ
Pancreatitis
puplesija,
Hepato-biliary disorders
attakki iskemiċmomentanji) inklużl- imwiet.
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
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
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
erebro- vaskulari, kellhom
Skin and subcutaneous tissue disorders
fatturi ta ’ riskju li kienu jeż minn qabel.
Rash
istu
Photosensitivity reaction Alopecia
kienu identifikati bħ fatturi ta ’ riskju għ CVAE f’ assoċ
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
ala al
High creatine phosphokinase Increased total bilirubin
L -
Increased alkaine phosphatase
effikaċ ta ’ olanzapine ma kienitx stabbilita f’ dawn l- istudji. ja
Weight gain ≥ 7% of baseline body weight was very common and ≥
Marda ta 'Parkinson Mhux rakkomandat l- uż ta' olanzapine fit- trattament tal- psikożassoċ ma 'l- agonisti ta ’ dopamine
15% of baseline body
u
64
i
weight was common.
f' pazjenti li għ andhom il- marda ta 'Parkinson.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
sezzjoni 4. 8), u olanzapine ma kienx aktar effettiv mill- plaċ fit- trattament tas- sintomi psikotiċ F' dawn
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
l- istudji, il- pazjenti inizjalment kellhom ikunu stabblizzati fuq id- doż l- aktar baxxa effettiva tal- mediċ
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
kontra l- marda ta ’ Parkinson (agonist ta ’ dopamine) u biex jibqgħ fuq l- istess mediċ u dożkontra l -
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
urnata u ż bil- mod għ marda ta ’ Parkinson matul l- istudju. ta '15 mg/ ġ urnata ibbaż fuq il- ġ
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
Olanzapine inbeda b '2. 5 mg/ ġ
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
died
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
all- massimu
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’ s disease, worsening of Parkinsonian symptomatology and ha llucinations were reported very commonly and more frequently than with placebo.
at
Speech disorder was also reported commonly.
udizzju tar- riċ erkatur.
During treatment with olanzapine in combination with lithium or divalproex, an increase of  7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Is- Sindromu Newrolettiku Malinn (NMS) NMS tista 'tkun kundizzjoni potenzjalment fatali assoċ ma' prodotti mediċ antipsikotiċ Każ rari li ġ rappurtati bħ NMS kienu rrappurtati f' assoċ
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of  from baseline body weight in 39.9% of 7% patients.
ijiet
65 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
ew
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
ala
Very common (≥ 10%), common (≥ 1% and < 10%).
jazzjoni ma 'olanzapine ukoll.
Weight gain9, elevated triglyceride levels10, increased appetite.
Manifestazzjonijiet kliniċta 'NMS huma deni għ ebusija tal- muskoli, stat mentali alterat u evidenza ta'
11 Common:
oli,
Elevated cholesterol levels Nervous system disorders Very common:
instabbiltà awtonomika (pressjoni tad- demm jew tal- polz irregolari, takikardija, dijaforeż u taħ tal -
Sedation (including: hypersomnia, lethargy, somnolence).
qalb irregolari).
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
Sinjali oħ jistgħ jinkludu creatinine phosphokinase elevat, mijoglobina fl- awrina (rabdomajoliż u insuffiċ
Investigations Very common:
jenza akuta renali.
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
Jekk pazjent jiż viluppa sinjali u sintomi li huma indikattivi ta '
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
NMS, jew ikollu deni għ bla ebda spjegazzjoni u mingħ manifestazzjonijiet kliniċoħ ta 'NMS,
4.9 Overdose
oli
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.
ajr
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
i ra
66 Management of overdose There is no specific antidote for olanzapine.
għ andhom jitwaqqfu l- mediċ antipsikotiċkollha, inkluż
Induction of emesis is not recommended.
olanzapine.
Cardiovascular monitoring is necessary to detect possible arrhythmias.
Ipergliċ emija u dijabete Zokkor għ fid- demm u/ jew ż
5.
oli
PHARMACOLOGICAL PROPERTIES
vilupp jew taħ tad- dijabete xi rix
5.1 Pharmacodynamic properties
kultant assoċ ma 'ketoaċ jati
N05AH03.
idozi jew
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
F' xi każ qabel kien hemm
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.
i
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.
ijiet
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).
i,
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition
Għ i
67 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.
ed ġ
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.
al al
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).
andu jingħ parir ata
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.
għ monitoraġ kliniku xieraq speċ al jalment f' pazjenti li għ andhom id- dijabete u f' pazjenti li għandhom fatturi ta 'riskju għ all- iż vilupp ta ’ dijabete mellitus u li għalihom huwa rakkomandat li b’ mod regolari jiġ i eżaminat iz- zokkor fid- demm.
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.
Tibdil fil- livelli tal- lipidi Ġ osservati alterazzjonijiet mhux mixtieqa fil- lipidi f’ pazjenti ttrattati b’ olanzapine fi provi kliniċ ew i kkontrollati bi plaċ (ara sezzjoni 4. 8).
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
Tibdil fil- livell tal- lipidi għ
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
andu jiġ
5.2 Pharmacokinetic properties
kkontrollat b’ mod i
The absorption is not affected by food.
klinikamet xieraq speċ
Absolute oral bioavailability relative to intravenous administration has not been determined.
jalment f’ pazjenti b’ ammonti mhux normali ta ’ lipidi fid- demm u f’ pazjenti li
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
għ andhom fatturi ta ’ riskju għ
The major circulating metabolite is the 1 0-N-glucuronide, which does not pass the blood brain barrier.
all- iż vilupp ta ’ disturbi fil- lipidi.
The predominant pharmacologic activity is from the parent olanzapine.
Attività antikolinerġ ika
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Meta olanzapine wera attività antikolinerġ in vitro, l- esperjenza waqt l - istudji kliniċ wriet
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
inċ idenza ta 'avvenimenti relatati.
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.
Madankollu billi l - esperjenza klinika ma 'olanzapine
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
64 f’ pazjenti li kellhom mard ieħ hi limitata ħ afna, wieħ irid joqgħ attent ħ
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).
ed
68 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).
od
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).
afna meta
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
jippreskrivi għ pazjenti bi prostata kbira, jew paralytic ileus u kundizzjonijiet relatati. al
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.
Għ
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
andu jkun hemm kawtela fil- każ pazjenti b' ALT u/ jew AST elevati, ta '
Olanzapine is bound predominantly to albumin and α -acid-glycoprotein.
pazjenti b' sinjali u sintomi ta 'problemi fil- fwied, f' pazjenti b' kundizzjonijiet eż istenti minn qabel assoċjati ma' riż funzjonali limitata tal- fwied, u f’ pazjenti li jkunu qed jiġ ttrattati b' mediċ li jkunu
1
u
The pharmacokinetics of olanzapine are similar between adolescents and adults.
potenzjalment tossiċgħ i all- fwied.
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Fil- każ ALT u/ jew AST elevati waqt it- trattament, wieħ għ
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
ed andu
Such factors possibly contribute to the higher average exposure observed in adolescents.
jsegwi l- każ sewwa u jikkunsidra tnaqqis fid- doż Fil- każ fejn tkun ingħ dijanjosi ta 'epatite
5.3 Preclinical safety data
ijiet a. ijiet
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.
(inkluż epatoċ ellulari, kolestatika jew korriment imħ tal- fwied), it- trattament b' olanzapine għ jitwaqqaf.
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Għ andha tingħ attenzjoni kbira f' pazjenti b' għ baxx ta 'lewkoċ u/ jew newtrofili minħ
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
kwalunkwe raġ f' pazjenti li jkunu ngħ
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
uni,
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
ataw mediċ magħ li jikkawż newtropenja, f' pazjenti bi ini rufa aw
Growth parameters were decreased at high doses.
storja ta 'dipressjoni/ tossiċ fil- mudullun ikkawż minn mediċ f' pazjenti b' dipressjoni fil- mudullun
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.
ini,
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.
ikkawż minn mard kontemporanju, terapija bir- radjazzjoni jew kimoterapija u f' pazjenti ata b' kundizzjonijiet iperesinofiliċjew b' mard mijeloproliferattiv.
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).
In- newtropenja kienet ukoll irrappurtata i komunement meta olanzapine u valproate ntuż flimkien (ara sezzjoni 4. 8). aw
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Twaqqif tal- kura B’ mod rari ħ ġ irrappurtati (< 0. 01%) sintomi akuti bħ għ
Reproductive toxicity Olanzapine had no teratogenic effects.
al araq, insomnja, rogħ ansjetà, tqalligħ da,,
Sedation affected mating performance of male rats.
meta olanzapine twaqqaf f' daqqa.
69 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.
L- Intervall QT Fi studji kliniċ ż fil- QTc li kienu klinikament sinifikanti (korrezzjoni fil- QT skond Fridericia i, idiet [QTcF] U > 500 millisekondi [msek] f’ kwalunkwe ħ wara l- valur baż f’ pazjenti b’ valur baż ta ’
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
QTcF < 500 msek) ma kienux komuni (0. 1% sa 1%) f’ pazjenti kkurati b’ olanzapine, b’ ebda differenza sinifikattiva fl- avvenimenti assoċ kardijaċmeta mqabbla ma ’ plaċ Madankollu, bħ b' antipsikotiċoħ għ
6.
i i
PHARMACEUTICAL PARTICULARS
ebo.
6.1 List of excipients
al
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
i ra, andha tittieħ kawtela meta olanzapine jingħ ma 'mediċ oħ li huma magħ li jż l- intervall QTc, speċ
6.2 Incompatibilities
ata
Not applicable.
ini ra
6.3 Shelf life
rufa
2 years.
idu
6.4 Special precautions for storage
jalment fl- anzjani, f' pazjenti b' sindromu konġ enitali ta 'QT twil,
This medicinal product does not require any special storage conditions.
insuffiċjenza tal- qalb konġestiva, ipertrofija tal- qalb, potassju baxx fid- demm jew manjesju baxx fid - demm.
6.5 Nature and contents of container
Tromboemboliż
Blister pack (OPA/ Al/ PVC, Al-foil):
B’ mod rari ħ (< 0. 01%) ġ irrapportata assoċ
14, 28, 35, 56 or 70 tablets in a box.
jazzjoni temporali bejn il- kura b’ olanzapine u t -
Not all pack sizes may be marketed.
tromboemboliż fil- vini.
6.6 Special precautions for disposal
mu
Any unused product or waste material should be disposed of in accordance with local requirements.
ali
7.
mu
MARKETING AUTHORISATION HOLDER
b’ olanzapine ma ġ stabbilita.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
iti at- tromboemboliż fil- vini, il- fatturi possibbli kollha ta ’ riskju ta ’ VTE mu eżl- immobbilizzazzjoni tal- pazjenti, għ. andhom jiġ identifikati u meħ l- miż ta ’ prevenzjoni.
8.
u
EU/ 1/ 07/ 415/ 022-026
uda
9.
uri
27 September 2007.
Attività tas- CNS ġ
70 10.
enerali
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Minħ abba l- effetti primarji ta 'olanzapine fuq is- CNS għandha tittieħ kawtela meta dan jingħ flimkien ma' mediċ oħ li jaġ
71 1.
ixxu ċ
Zalasta 20 mg tablets
ed
2.
ata
QUALITATIVE AND QUANTITATIVE COMPOSITION
ini ra
Each tablet contains 20 mg olanzapine.
entralment u meta jittieħ ma 'l- alkoħ Minħ ed ol.
Excipient:
abba li in vitro juri
Each tablet contains 323.5 mg lactose.
antagoniż għ dopamine, olanzapine jista 'jantagonizza l- effetti diretti u indiretti ta' l- agonisti ta ’ mu al dopamine.
For a full list of excipients, see section 6.1.
ċ Aċessjonijiet
3.
ġ
PHARMACEUTICAL FORM
Olanzapine għ
Tablet.
andu jintuż
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription “ 20”.
b' kawtela f' pazjenti li jkollhom storja ta 'aċessjonijiet jew li jkunu suġetti a ċ ċ
4.
al
4.1 Therapeutic indications
u
Adults Olanzapine is indicated for the treatment of schizophrenia.
Rarament kienu rrappurtati aċessjonijiet ċ
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
F' ħ mill- każ kienu rappurati fatturi ta 'riskju għ
Olanzapine is indicated for the treatment of moderate to severe manic episode.
ċ
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
afna
4.2 Posology and method of administration
ijiet
Adults Schizophrenia:
all- aċessjonijiet
The recommended starting dose for olanzapine is 10 mg/ day.
jew storja ta 'aċessjonijiet.
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
65 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
Preventing recurrence in bipolar disorder:
idenza statistikament iktar
The recommended starting dose is 10 mg/ day.
baxxa ta 'diskajneż emerġ mit- trattament.
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Madankollu r- riskju ta 'diskajneż tardiva jiż
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.
ja
72 Olanzapine can be given without regards for meals as absorption is not affected by food.
enti
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.
ja ċ
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).
died
In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
b' esponiment fit- tul, u għ alhekk jekk jitfaċaw sintomi ta 'diskajneż tardiva f' pazjenti li jkunu qed jieħ olanzapine, wieħ għ
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
ja
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
du
Dose escalation, when indicated, should be conservative in such patients.
ed andu jikkunsidra li jnaqqas jew iwaqqaf id- doż Dawn is- sintomi jistgħ
(See sections 4.5 and 5.2.)
a.
4.3 Contraindications
u
Hypersensitivity to the active substance or to any of the excipients.
jiddeterjoraw temporanjament jew saħ
Patients with known risk for narrow-angle glaucoma.
ansitra jitfaċaw wara li jitwaqqaf it- trattament.
4.4 Special warnings and precautions for use
Pressjoni baxxa mal- waqfien
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Il- pressjoni baxxa relatata mat- tibdil tal- poż izzjoni kienet osservata mhux frekwentement fl- anzjani fi studji kliniċb' olanzapine.
Patients should be closely monitored during this period.
Bħ fil- każ mediċ antipsikotiċoħ hu rrakkomandat li l- pressjoni
1.5%, respectively).
i ra,
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.
tibda titkejjel perjodikament fil- pazjenti ta 'iktar minn 65 sena.
There was a 3-fold increase in CVAE in patients treated
L- uż fit- tfal u fl- adolexxenti taħit- 18- il sena
73 with olanzapine compared to patients treated with placebo (1.3% vs.
Olanzapine mhux indikat għ
0.4%, respectively).
fil- kura tat- tfal u adolexxenti.
The efficacy of olanzapine was not established in these trials.
Studji f' pazjenti bejn it- 13 u s- 17- il sena u
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
wrew reazzjonijiet avversi varji, fosthom ż fil- piżtibdil fil- parametri metaboliċu ż fil- livelli ta '
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
L- effetti fit- tul assoċ ma 'dawn l- avvenimenti ma ġ studjati u għ (ara sezzjonijiet 4. 8 u 5. 1).
Rare cases reported as NMS have also been received in association with olanzapine.
Il- pilloli Zalasta jkun fihom il- lactose.
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Il- pazjenti bi problemi ereditarji rari ta 'intolleranza għall- galactose, defiċ jenza ta ’ Lapp lactase jew nuqqas ta' assorbiment tal- glukoż mediċ ina.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
andhomx jieħ din il - du
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
4. 5 Prodotti mediċinali oħ li ma jaqblux ma ’ dan il- prodott u affarijiet oħ li jistgħ jibdlu l -
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
ra ra
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
u
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
ewtiku tal- prodott
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
Studji dwar l- effett ta ’ mediċ jew ta ’ affarijiet oħ fuq l- effett farmaċ biss.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
ra
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
ewtiku tal- prodott saru fl- adulti
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.
Interazzjonijiet potenzjali li jaffettwaw olanzapine Billi olanzapine jiġmetabolizzat bis- CYP1A2, sustanzi li speċ
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
ifikament jinduċ jew jinibixxu dan l - u
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
isoenzim jistgħ jaffettwaw il- farmakokinetika ta 'olanzapine. u
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Induzzjoni ta 'CYP1A2 Il- metaboliż ta' olanzapine jista 'jiġindott mit- tipjip u minn carbamazepine, li jista' jwassal għ
Seizures have been reported to occur rarely in patients when treated with olanzapine.
entrazzjoni ta 'olanzapine.
In most of these cases, a history of seizures or risk factors for seizures was reported.
Ġ osservata biss ż ħ
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
tnaqqis fil- konċ
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
iet
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
ieda afifa jew moderata fit- tneħija ta '
75 Lactose Zalasta tablets contain lactose.
olanzapine.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Il- konsegwenzi kliniċaktarx li huma limitati, iż hu rakkomandat li ssir sorveljanza klinika
4.5 Interaction with other medicinal products and other forms of interaction
u tista 'tiġkkunsidrata ż fid- doż ta' olanzapine jekk ikun meħ
Interaction studies have only been performed in adults.
ied
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.
a a
Only slight to moderate increase in olanzapine clearance has been observed.
tieġ( ara sezzjoni 4. 2).
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
66 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.
76 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Patients should be advised to notify their physician if they b ecome pregnant or intend to become pregnant during treatment with olanzapine.
Il- pazjenti għ andhom jingħataw parir hom jekk joħ u tqal jew jekk ikun fi ħ biex jgħarrfu lit- tabib tagħ
78
la
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
69 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
79 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Għ imwettqa studji kliniċmagħ
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
pazjenti adolexxenti, il- medja taż ieda fil- piż żejjed jew kienu obeż i.
80 Management of overdose There is no specific antidote for olanzapine.
iċ Il- ġestjoni ta 'dożeċessivi Ma hemm l- ebda antidotu speċ għ olanzapine.
81 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.
72 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).
73 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 -
82 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
83 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 5 mg orodispersible tablets
Zalasta 20 mg pilloli
Each orodispersible tablet contains 5 mg olanzapine.
Kull pillola fiha 20 mg olanzapine.
Each orodispersible tablet contains 0.50 mg aspartame.
Kull pillola fiha 323. 5 mg lactose.
Orodispersible tablet.
Pillola.
Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Il- pilloli huma tondi, xi ftit konvessi, jagħ fl- isfar possibbilment b' tikek sofor individwali u bl - tu iskrizzjoni “ 20 ”.
86 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.
ix
Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Meta jkun sa jitwaqqaf it- trattament, wieħ għed andu jikkunsidra t- tnaqqis tad- doż bil- mod il- mod. a
Removal of the intact orodispersible tablet from the mouth is difficult.
Tfal u adolexxenti Olanzapine mhux irrakkomandat għ
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
all- uż
Alternatively, it may be dispersed in a full glass of water immediately before administration.
fit- tfal u fl- adolexxenti ta ’ taħit- 18- il sena peress li u t
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
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
It has the same dosage and frequency of administration as olanzapine tablets.
mijiet u prolactin f’ pazjenti adolexxenti milli fl- istudji ta ’ pazjenti
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
adulti (ara sezzjonijiet 4. 4, 4. 8, 5. 1 u 5. 2).
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consider ation should be given to decreasing the starting dose.
li jista 'jnaqqas il- metaboliż (pazjenti nisa, pazjenti anzjani,
Dose escalation, when indicated, should be conservative in such patients.
pazjenti li ma jpejpux), wieħ għ
In cases where dose increments of 2.5 mg are considered necessary, Zalasta tablets should be used.
Għ dawn il- pazjenti, meta jkun indikat, id- doż għ a andha tiż b' moderazzjoni. died
In placebo-controlled clinical trials (6-12 weeks
kkontrollati bil- plaċ (li damu i ebo
87 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
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
sedazzjoni, il- malnutriment u d- deidrazzjoni, kundizzjonijiet tal- pulmun (eż
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Madankollu, l- inċ
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
kienet ogħ f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil- plaċ indipendentement
In these trials, patients wer e initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
kontra l- marda ta ’ Parkinson (agonist ta ’ dopamine) u biex jibqgħ fuq l- istess mediċ u dożkontra l -
Additi onal signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Sinjali oħ jistgħ jinkludu creatinine phosphokinase elevat, mijoglobina fl- awrina (rabdomajoliż u insuffiċ
88 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Għ
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.
80 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
89 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Il- pressjoni baxxa relatata mat- tibdil tal- poż izzjoni kienet osservata mhux frekwentement fl- anzjani fi studji kliniċb' olanzapine.
Aspartame Zalasta orodispersible tablets contain aspartame, a source of phenylalanine.
Il- pazjenti bi problemi ereditarji rari ta 'intolleranza għall- galactose, defiċ jenza ta ’ Lapp lactase jew nuqqas ta' assorbiment tal- glukoż mediċ ina.
May be harmful for people with phenylketonuria.
andhomx jieħ din il - du
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
81 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.
90 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
tieġ ġ Is- sorveljanza terapewtika tal- livelli ta ’ valproate fil- plaż ma indikatx li hu meħ aġustament fid - ma doż ta 'valproate wara l- introduzzjoni ta' olanzapine fl- istess ħ a in.
Spontaneous reports have been ver y rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
evuti rapporti spontanji ħ ta 'rogħ ipertonija, letarġ u ngħ qawwi, fi tfal ż ar Kienu riċ
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appet ite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
eridi (ara sezzjoni 4. 4), glukosurja, ż fl- aptit, għ ta 'prolactin, kolesterol, glucose u trigliċ
Eosinophilia
assoċ ma ’ jata
Leukopenia Neutropenia
glucose4 Livelli għ ta '
Thrombocytopenia Allergic reaction
inklużxi każ fatali i ijiet
91 Metabolism and nutrition disorders Weight gain1
eridi Glikosurja Ż ieda fl- aptit
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Disturbi fis- sistema nervuż a ċ Sonnolenza
Nervous system disorders Somnolence
Sturdament
Dizziness Akathisia6
Aċessjonijiet li fil - ġ
6
Akatizja6 Parkinsoniż Diskineż 6
Parkinsonism 6
6 mu
seizures or risk factors
maġoranza tagħ hom kien rrappurtat passat
Dyskinesia
ja
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
mediku ta 'ċ aċessjonijiet jew fatturi tar- riskju għall - ċ aċessjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okuloġ irazzjoni) Diskineż tardiva ja Sintomi ta' twaqqif tal - kura 7
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders
Disturbi muskolu- skeltrali u tal- connective tissue Rabdomijoliż i Disturbi fil- kliewi u fis- sistema urinarja Eż itazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapiżmu Disturbi ġ enerali u kondizzjonijiet ta 'mnejn jingħ ata Astenja Għ eja Edima Investigazzjonijiet Ż Livelli elevati ta' prolactin fil- plaż 8
92 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
ma
weight was common.
isem kienet komuni.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
2
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
84 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
93 In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
Fi studju kliniku wieħ f' pazjenti b' manija bipolari, terapija b’ valproate flimkien ma 'olanzapine rriż
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Għ imwettqa studji kliniċmagħ
Elevated cholesterol levels11 Nervous system disorders Very common:
Livelli għ ta 'kolesterol11 olja Disturbi fis- sistema nervuż
94 Signs and symptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
aġitazzjoni/ agressività, dysarthria, diversi sintomi estrapiramidali, u tnaqqis fil- livell ta 'konoxxenza tal - pazjent li tvarja minn sedazzjoni għ koma. al
Management of overdose There is no specific antidote for olanzapine.
iċ Il- ġestjoni ta 'dożeċessivi Ma hemm l- ebda antidotu speċ għ olanzapine.
95 In a multinationational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
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).