qanastek/EMEA-V3 huggingface dataset:
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
Meta hemm aktar minn fattur wieħed li jista 'jirriżulta f' metaboliżmu aktar bil- mod (sess femminili, età ġerjatrika, individwu ma jpejjipx), għandha tingħata kunsiderazzjoni biex titnaqqas id- doża tal- bidu.
Dose escalation, when indicated, should be conservative in such patients.
Żjieda fid- doża, meta indikata, għandha tkun konservattiva f' dawn il- pazjenti.
(see sections 4.5 and 5.2.)
(Ara sezzjonijiet 4. 5 u 5. 2)
Hypersensitivity to the active substance, peanut or soya or to any of the excipients.
Sensittivita 'eċċessiva għas- sustanza attiva, għall- karawett jew is- soja jew għal xi sustanzi mhux attivi.
Patients with known risk for narrow-angle glaucoma.
Pazjenti li għandhom ir- riskju ta 'glawkoma tat- tip narrow angle.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Waqt trattament bl- antipsikotiċi, titjib fil- kundizzjoni klinika tal- pazjent għandu mnejn isir fuq medda ta ’ diversi granet għal xi ftit gimgħat.
Patients should be closely monitored during this period.
Il- pazjenti għandhom jiġu monitorjati sew waqt dan il- perjodu.
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Psikożi relatata mad- demenzja u/ jew disturbi fil- komportament Olanzapine mhux approvat għat- trattament tal- psikożi relatata mad- demenzja u/ jew disturbi fil - komportament, u mhux irrakkomandat għall- użu f’ dan il- grupp partikolari ta ’ pazjenti, dovut għal żieda fil- mortalità u r- riskju ta ’ inċident ċerebro- vaskulari.
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.
Fi studji kliniċi kkontrollati bil- plaċebo (li damu minn 6 sa 12- il ġimgħa), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożi relatata mad- demenzja u/ jew disturbi fil- komportament, kien hemm żieda ta ’ darbtejn akbar fl- inċidenza ta ’ mwiet fil- pazjenti ttrattati b' olanzapine, mqabbla ma ’ pazjenti ttrattati bil- plaċebo (3. 5% kontra 1. 5%, rispettivament).
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
L- inċidenza ogħla ta ’ l- imwiet ma kienitx assoċjata mad- doża ta ’ olanzapine (doża medja kuljum ta ’ 4. 4 mg) jew it- tul ta ’ żmien 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.
Madankollu, l -
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
3 inċidenza ta ’ l- imwiet kienet ogħla f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil - plaċebo, indipendentement minn dawn il- fatturi ta ’ riskju.
3 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Fl- istess studji kliniċi, kienu rrapportati avvenimenti avversi ċerebro- vaskulari (CVAE eż puplesija, attakki iskemiċi momentanji) inklużi l- imwiet.
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
Kien hemm żieda ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4U%, rispettivament).
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Il- pazjenti kollha ttrattati b' olanzapine jew bi plaċebo u li kellhom avveniment ċerebro- vaskulari, kellhom fatturi ta ’ riskju li kienu jeżistu minn qabel.
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
L- età ta ’ > 75 sena u d - demenzja tat- tip vaskulari jew imħallta kienu identifikati bħala fatturi ta ’ riskju għal CVAE f’ assoċjazzjoni ma ’ trattament b' olanzapine.
The efficacy of olanzapine was not established in these trials.
L- effikaċja ta ’ olanzapine ma kienitx stabbilita f’ dawn l - istudji.
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Marda ta 'Parkinson Mhux rakkomandat l- użu ta' olanzapine fit- trattament tal- psikożi assoċjata ma 'l- agonisti ta ’ dopamine f' pazjenti li għandhom il- marda ta' Parkinson.
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Fi studji kliniċi, id- deterjorament fis- sintomi tal- marda ta ’ Parkinson u alluċinazzjonijiet kienu rrappurtati b’ mod komuni ħafna u aktar ta 'spiss milli bil - plaċebo (ara sezzjoni 4. 8), u olanzapine ma kienx aktar effettiv mill- plaċebo fit- trattament tas- sintomi psikotiċi.
In these trials, patients were 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.
F' dawn l- istudji, il- pazjenti inizjalment kellhom ikunu stabblizzati fuq id- doża l- aktar baxxa effettiva tal- mediċini kontra l- marda ta ’ Parkinson (agonist ta ’ dopamine) u biex jibqgħu fuq l- istess mediċini u dożi kontra l- marda ta ’ Parkinson matul l- istudju.
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgment.
Olanzapine inbeda b '2. 5 mg/ ġurnata u żdied bil- mod għall- massimu ta' 15 mg/ ġurnata ibbażat fuq il- ġudizzju tar- riċerkatur.
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Is- Sindromu Newrolettiku Malinn (NMS) NMS tista 'tkun kundizzjoni potenzjalment fatali assoċjata ma' prodotti mediċinali antipsikotiċi.
Rare cases reported as NMS have also been received in association with olanzapine.
Każijiet rari li ġew rappurtati bħala NMS kienu rrappurtati f' assoċjazzjoni ma 'olanzapine ukoll.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Manifestazzjonijiet kliniċi ta 'NMS huma deni għoli, ebusija tal- muskoli, stat mentali alterat u evidenza ta' instabbiltà awtonomika (pressjoni tad- demm jew tal- polz irregolari, takikardija, dijaforeżi, u taħbit tal- qalb irregolari).
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Sinjali oħra jistgħu jinkludu creatinine phosphokinase elevat, mijoglobina fl- awrina (rabdomajoliżi) u insuffiċjenza akuta renali.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicinal products, including olanzapine must be discontinued.
Jekk pazjent jiżviluppa sinjali u sintomi li huma indikattivi ta 'NMS, jew ikollu deni għoli bla ebda spjegazzjoni u mingħajr manifestazzjonijiet kliniċi oħra ta' NMS, għandhom jitwaqqfu l- mediċini antipsikotiċi kollha, inkluż olanzapine.
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported very rarely, including some fatal cases (see section 4.8).
Ipergliċemija u dijabete Zokkor għoli fid- demm u/ jew żvilupp jew taħrix tad- dijabete xi kultant assoċjati ma 'ketoaċidozi jew koma kienu rrappurtati b’ mod rari, inklużi xi każijiet fatali (ara sezzjoni 4. 8).
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
F' xi każijiet, ġiet rapurtata żjieda fil- piż tal- ġisem u din tista 'tkun fattur ta ’ predisposizzjoni.
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.
Għandu jingħata parir għal monitoraġġ kliniku xieraq speċjalment f' pazjenti li għandhom id- dijabete u f' pazjenti li għandhom fatturi ta 'riskju għall- iżvilupp ta ’ dijabete mellitus u li għalihom huwa rakkomandat li b’ mod regolari jiġi eżaminat iz- zokkor fid- demm.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
Tibdil fil- livelli tax- xaħmijiet Fi studji kliniċi kkontrollati bi plaċebo, ġie osservat tibdil mhux mixtieq fil- livell tax- xaħmijiet f’ pazjenti kkurati b’ olanzapine (ara sezzjoni 4. 8).
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Tibdil fil- livell tax- xaħmijiet għandu jiġi kkontrollat b’ mod klinikamet xieraq speċjalment f’ pazjenti b’ ammonti mhux normali ta ’ xaħmijiet fid- demm u f’ pazjenti li għandhom fatturi ta ’ riskju għall- iżvilupp ta ’ disturbi fix- xaħmijiet.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Attività antikolinerġika Waqt li olanzapine wera attività antikolinerġika in vitro, ersperjenza waqt il- provi kliniċi uriet inċidenza baxxa ta 'ġrajjiet relatati.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
Madankollu, minħabba li esperjenza klinika b' olanzapine f' pazjenti b' mard konkomitanti hija limitata, għandha tittieħed kawtela meta jkun preskritt għall- pazjenti b' ipertrofija tal- prostata, jew b' ileus paralitiku u kundizzjonijiet relatati.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Funzjoni epatika Elevazzjonijiet li ma jurux sintomi ta 'l- enżimi transaminases tal- fwied, ALT, AST għal żmien qasir kienu komuni, speċjalment fil- bidu tat- trattament.
Caution should be exercised in patients with elevated ALT and/ or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicinal products.
Fil- każ ta 'ALT
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
4 u/ jew AST elevati waqt it- trattament, għandha tiġi organiżżata investigazzjoni oħra u għandha tiġi kkunsidrata tnaqqis fid- doża.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
F' każijiet fejn saret dijanjożi ta ’ l- epatite( inkluż il- mard tal- fwied epatoċellulari, kolestatiku jew tat- tip imħallat), it- trattament ta 'olanzapine għandu jitwaqqaf.
4 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.
Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal - mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
In- newtropenja kienet rappurtata spiss meta olanzapine u l- valproate intużaw flimkien (ara Sezzjoni 4. 8).
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.
Twaqqif tal- kura B’ mod rari ħafna ġew irrappurtati (< 0. 01%) sintomi akuti bħal għaraq, insomnja, rogħda, ansjetà, tqalligħ, jew rimettar meta olanzapine twaqqaf f' daqqa.
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.
L- Intervall QT Fi studji kliniċi, żidiet fil- QTc li kienu klinikament sinifikanti (korrezzjoni fil- QT skond Fridericia [QTcF] U > 500 millisekondi [msek] f’ kwalunkwe ħin wara l- valur bażiku f’ pazjenti b’ valur bażiku ta ’ QTcF < 500 msek) ma kienux komuni (0. 1% sa 1%) f’ pazjenti kkurati b’ olanzapine, b’ ebda differenza sinifikattiva fl- avvenimenti assoċjati kardijaċi meta mqabbla ma ’ plaċebo.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicinal products known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Madankollu, bħal b' antipsikotiċi oħra, għandha tittieħed kawtela meta olanzapine jingħata ma 'mediċini oħra li huma magħrufa li jżidu l- intervall QTc, speċjalment fl- anzjani, f' pazjenti b' sindromu konġenitali ta' QT twil, insuffiċjenza tal- qalb konġestiva, ipertrofija tal- qalb, potassju baxx fid- demm jew manjesju baxx fid - demm.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
Tromboemboliżmu B’ mod rari ħafna (< 0. 01%) ġiet irrapportata assoċjazzjoni temporali bejn il- kura b’ olanzapine u t - tromboemboliżmu fil- vini.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Relazzjoni kawżali bejn l- okkorrenza ta ’ tromboemboliżmu fil- vini u l - kura b’ olanzapine ma ġietx stabbilita.
However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e. g. immobilisation of patients, should be identified and preventive measures undertaken.
Madankollu peress li pazjenti b’ skizofrenija ħafna drabi jippreżentaw b’ fatturi ta ’ riskju akkwiżiti għat- tromboemboliżmu fil- vini, il- fatturi possibbli kollha ta ’ riskju ta ’ VTE eż. l- immobbilizzazzjoni tal- pazjenti, għandhom jiġu identifikati u meħuda l- miżuri ta ’ prevenzjoni.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicinal products and alcohol.
Attività tas- CNS ġenerali Minħabba l- effetti primarji ta 'olanzapine fuq is- CNS għandha tittieħed kawtela meta dan jingħata flimkien ma' mediċini oħra li jaġixxu ċentralment u meta jittieħed ma 'l- alkoħol.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Minħabba li in vitro juri antagoniżmu għal dopamine, olanzapine jista 'jantagonizza l- effetti diretti u indiretti ta' l- agonisti ta ’ dopamine.
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.
Aċċessjonijiet Olanzapine għandha tintuża b' kawtela f' pazjenti li għandhom passat ta 'aċċessjonijiet jew li huma soġġetti għall- fatturi li jistgħu jbaxxu l- limitu ta' l- aċċessjonijiet.
Seizures have been reported to occur rarely in patients when treated with olanzapine.
Kienu rarament rappurtati aċċessjonijiet f' pazjenti meta trattati b' olanzapine.
In most of these cases, a history of seizures or risk factors for seizures were reported.
Fil- maġġoranza ta 'dawn il- każijiet, passat ta' aċċessjonijiet jew fatturi ta 'riskju għal aċċessjonijiet kienu rappurtati.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Diskajneżja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien assoċjat ma 'inċidenza mnaqqsa ta' diskajneżja f' riżultat tat- trattament b' sinifikat statistikament validu.
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.
Madankollu, r- riskju ta 'diskajneżja tardiva jiżdied b' espożizzjoni għal żmien twil, u għalhekk jekk jidhru s- sinjali jew is- sintomi ta' diskajneżja tardiva f' pazjenti li qed jieħdu olanzapine, għandu jiġi kkunsidrat tnaqqis fid- doża jew il - waqfien.
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Dawn is- sintomi jistgħu jiżdiedu biż- żmien kif ukoll joħorġu wara li jitwaqqaf it- trattament.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
5 Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
Bħal b' antipsikotiċi oħra, huwa rakkomandat li l- pressjoni tad- demm tkun meħuda perjodikament f' pazjenti 'l fuq minn 65 sena.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Studji f' pazjenti bejn it- 13 u s- 17- il sena wrew reazzjonijiet avversi varji, fosthom żieda fil- piż, tibdil fil- parametri metaboliċi u żieda fil - livelli ta 'prolactin.
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
L- effetti fit- tul assoċjati ma 'dawn l- avvenimenti ma ġewx studjati u għadhom mhux magħrufa (ara sezzjonijiet 4. 8 u 5. 1).
5 Olanzapine tablets contain lactose monohydrate.
Lactose Il- pilloli OLANZAPINE fihom l- lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, ta ’ nuqqas tal- Lapp lactase jew ta ’ nuqqas fl- assorbiment ta ’ glucose- galactose m’ għandhomx jieħdu din il- mediċina.
The film-coating contains soya lecithin.
Ir- rita li bija miksija il- pillola fiha il- lecitin tas- soja.
Patients who are allergic to peanut or soya must not take these tablets.
Pazjenti li huma allergici għall- karawett jew is- soja, ma jistawx jieħdu dawn il- pilloli.
4.5 Interaction with other medicinal products and other forms of interaction
Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Interaction studies have only been performed in adults.
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru fl - adulti biss.
Potential interactions affecting olanzapine:
Potenzjal t' interazzjonijiet ma 'olanzapine U
Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Minħabba li olanzapine hija metaboliżżata b 'CYP1A2, sustanzi li jistgħu speċifikament jikkaġunaw jew jinibixxu din l- iżoenzima jistgħu jaffettwaw il- komportament farmakokinetiku ta' olanzapine.
Induction of CYP1A2:
Attivazzjoni ta 'CYP1A2 U
The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Il- metaboliżmu ta’ olanzapine jista 'jiġi kkawżat mit- tipjip u b' carbamazepine, li jistgħu jwasslu għal tnaqqis fil- konċentrazzjoni ta 'olanzapine.
Only slight to moderate increase in olanzapine clearance has been observed.
Ġiet osservata żjieda żgħira sa moderata fil- clearance ta 'olanzapine mill- ġisem.
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).
Il- konsegwenzi kliniċi x' aktarx huma limitati, imma hija rrakkomandata l - osservazzjoni klinika u tista 'tiġi kkunsidrata żjieda fid- doża ta' olanzapine jekk din tkun meħtieġa (ara Sezzjoni 4. 2).
Inhibition of CYP1A2:
Inibizzjoni ta 'CYP1A2 U
Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Fluvoxamine, inibitur speċifiku ta' CYP1A2, deher li jinibixxi sinifikatament il- metaboliżmu ta 'olanzapine.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female nonsmokers and 77% male smokers.
Iż- żjieda medja f ’ olanzapine Cmax wara t- teħid ta 'fluvoxamine kienet 54% fin- nisa li ma jpejpux u 77% fl- irġiel li jpejpu.
The mean increase in olanzapine AUC was 52% and 108% respectively.
Iż- żjieda medja fl- AUC ta 'olanzapine kienet 52% u 108% rispettivament.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Għandha tiġi kkunsidrata doża tal- bidu aktar baxxa ta 'olanzapine f' pazjenti li qed jużaw fluvoxamine jew xi inibituri oħra ta' CYP1A2, bħal ciprofloxacin.
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Għandha tiġi kkunsidrata tnaqqis fid- doża ta 'olanzapine jekk jinbeda xi trattament b' inibitur ta' CYP1A2.
Decreased bioavailability:
Biodisponibbiltà mnaqqsa U
Activated charcoal reduces the bioavailability of oral olanzapine by 50% to 60% and should be taken at least 2 hours before or after olanzapine.
Faħam attivat inaqqas il- biodisponibilità ta 'olanzapine li tittieħed mill- ħalq b' 50 sa 60% u għandu jittieħed għal ta 'l- inqas sagħtejn qabel jew wara olanzapine.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Fluoxetine (inibitur CYP2D6), dożi b ’ waħdiet t 'antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il- komportament farmakokinetiku ta' olanzapine.
Potential for olanzapine to affect other medicinal products:
Il- potenzjal ta 'olanzapine biex jaffetwa prodotti mediċinali oħra U
Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Olanzapine jista 'jantagonizza l- effetti ta' l- antagonisti ta ’ dopamine diretti jew indiretti.
1A2, 2D6, 2C9, 2C19, 3A4).
Olanzapine ma jinibixxix l- iżoenzimi CYP450 prinċipali in vitro (eż 1A2, 2D6, 2C19, 3A4).
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).
Għalhekk, ma hemm ebda reazzjoni partikolari mistennija kif verifikat minn studji in vitro fejn ma nstabet ebda inibizzjoni tal- metaboliżmu tas- sustanzi attivi li ġejjin: anti- dipressant triċikliku (jirrapreżenta l- aktar il- passaġġ permezz ta 'CYP2D6), warfarina (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
Olanzapine showed no interaction when co-administered with lithium or biperiden.
6 Olanzapine ma wera ebda reazzjoni meta ttieħed flimkien ma ’ lithium jew biperiden.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Osservazzjoni terapewtika tal- livelli ta ’ valproate fil- plażma ma ndikatx li tibdil fid- dożaġġ tal - valproate huwa meħtieġ wara l- introduzzjoni ta 'olanzapine ukoll.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
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).
Mhux rakkomandat l- użu konkomitanti ta 'olanzapine ma' prodotti mediċinali kontra l- Parkinson f' pazjenti bil- marda ta 'Parkinson u d- demenzja (ara sezzjoni 4. 4).
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
L- Intervall QTc Għandha tintuża l- kawtela jekk olanzapine qiegħed jingħata flimkien ma 'prodotti mediċinali magħrufa li jtawlu l- intervall QTc (ara sezzjoni 4. 4).
6 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
There are no adequate and well-controlled studies in pregnant women.
Ma hemm ebda studji adegwati u kkontrollati sewwa f' nisa waqt it- tqala.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Il- pazjenti għandhom jingħataw parir biex jgħarrfu lit- tabib tagħhom jekk jinqabdu tqal jew jekk qed jippjanaw li jinqabdu tqal waqt it- trattament b ’ olanzapine.
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Madankollu, minħabba li l- esperjenza fil- bniedem hija limitata, olanzapine għandha tintuża biss waqt it- tqala jekk il- benefiċju li jista 'jkun hemm jiġġustifika r- riskju li jista' jkun hemm fuq il- fetu.
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.
Rapporti spontanji u rari kienu rapportati dwar rogħda, ipertonja, letarġija u ngħas, fi trabi mwielda lill ommijiet li użaw olanzapine waqt l- aħħar 3 xhur tat- tqala.
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Fi studju fuq nisa b' saħħithom li qed ireddgħu, olanzapine tfaċċa fil- ħalib tas- sider.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Il- konċentrazzjoni medja fi studju stabbli tat- trabi kienet stimata li kienet 1. 8% tad- doża ta 'olanzapine fl- omm.
Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Pazjenti għandhom jingħataw parir biex ma jreddawx tarbija jekk qed jieħdu olanzapine.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Minħabba li olanzapine jista 'jikkawża sonnolenza u sturdament, il- pazjenti għandhom jiġu avżati dwar l- użu ta' magni, inklużi l - karozzi.
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.
Adulti Fi studji kliniċi, l- aktar reazzjonijiet avversi li ġew irrapportati b' mod frekwenti (jidhru f '> 1% tal - pazjenti) u li huma assoċjati ma' l- użu ta 'l- olanzapine kienu sonnolenza, żieda fil- piż, eosinofilja, livelli għolja ta' prolactin, kolesterol, glucose u trigliċeridi (ara sezzjoni 4. 4), glukosurja, żieda fl- aptit, sturdament, akatiżja, parkinsoniżmu (ara sezzjoni 4. 4), diskineżja, pressjoni baxxa mal- waqfien, effetti antikolinerġiċi, żieda fil- livelli tat- transaminases tal- fwied li ma jurux sintomi u li huma momentanji (ara sezzjoni 4. 4), raxx, astenja, għeja u edima.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Fit- tabella li ġejja huma mniżżla r- reazzjonijiet avversi u t- testijiet tal- laboratorju osservati minn rapporti magħmula b’ mod spontanju u minn studji kliniċi.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa tniżżlu skond is- serjetà tagħhom.
The frequency terms listed are defined as follows:
It- termini ta 'frekwenza elenkati huma mfissra kif ġej:
Very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Komuni ħafna (> 10%), komuni (> 1% u < 10%), mhux komuni (> 0. 1% u < 1%), rari (> 0. 01% u < 0. 1%), rari ħafna (< 0. 01%), mhux magħrufa (ma jistgħux jiġu stmati mill- informazzjoni li hemm disponibbli).
Eosinophilia
Eosinofilja
Leucopenia Neutropenia
Lewkopenja Newtropenja
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Disturbi fis- sistema immuni Reazzjoni allerġika Disturbi fil- metaboliżmu u n- nutrizzjoni Żieda fil- piż1
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
Livelli għolja ta 'kolesterol2, 3 Livelli għolja ta' glucose4 Livelli għolja ta 'trigliċeridi2, 5 Glikosurja Żieda fl- aptit
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Żvilupp jew iggravar tad- dijabete, xi kultant assoċjata ma ’ ketoaċidożi jew koma inklużi xi każijiet fatali (ara sezzjoni 4. 4) Ipotermija
Nervous system disorders 7 Somnolence Cardiac disorders
Disturbi fis- sistema nervuża Sonnolenza Disturbi fil- qalb
Dizziness Akathisia6 Parkinsonism6 Dyskinesia6
Sturdament Akatizja6 Parkinsoniżmu6 Diskineżja6
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Aċċessjonijiet li fil - maġġoranza tagħhom kien rrappurtat passat mediku ta 'aċċessjonijiet jew fatturi tar- riskju għall - aċċessjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okuloġirazzjoni) Diskineżja tardiva Sintomi ta' twaqqif tal - kura7
Bradycardia QTc prolongation (see section 4.4)
Bradikardija QTc imtawwal (ara sezzjoni 4. 4)
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Takikardija / fibrillazzjoni ventrikulari, mewt għall - għarrieda (ara sezzjoni 4. 4)
Orthostatic hypotension
Pressjoni baxxa mal - waqfien
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Tromboemboliżmu (inkluż l- emboliżmu pulmonari u t- trombożi tal- vini fil- fond)
Mild, transient anticholinergic effects including constipation and dry mouth
Effetti antikolinerġiċi ħfief u li jgħaddu malajr inklużi stitikezza u ħalq xott
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Żieda ta 'transaminases tal- fwied (ALT, AST) bla sintomi u li tgħaddi malajr, speċjalmet fil - bidu tal- kura (ara sezzjoni 4. 4)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Epatite inkluż mard tal- fwied tat- tip epatoċellulari, kolestatiku jew tat - tnejn flimkien)
Photosensitivity reaction Alopecia
Reazzjoni ta 'fotosensittività
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 1
8
Weight gain ≥ 7% of baseline body weight was very common and ≥ 15% of baseline
Alopeċja Disturbi muskolu- skeltrali u tal- connective tissue Rabdomijoliżi Disturbi fil- kliewi u fis- sistema urinarja Eżitazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapiżmu Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Astenja Għeja Edima Investigazzjonijiet Livelli elevati ta'
8 body weight was common.
8
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
Kien komuni ħafna li wara espożizzjoni għal perijodu twil ta’ żmien il- pazjenti jkollhom żieda fil- piż bażilari tagħhom ta ’ ≥ 25%.
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
2 Iż- żidiet medji fil- livelli tax- xaħmijiet waqt is- sawm (kolesterol totali, LDL kolesterol, u trigliċeridi) kienu ogħla f’ pazjent li fil- linja bażi ma wrewx evidenza ta ’ problemi fil- kontroll tax- xaħmijiet.
3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
3 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 5. 17 mmol/ l) li żdiedu għal għoljin (≥ 6. 2 mmol/ l).
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol) to high (≥ 6.2 mmol) were very common.
Tibdil fil- livelli tal- kolesterol totali waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 5. 17 mmol/ l - < 6. 2 mmol/ l) għal għoljin (≥ 6. 2 mmol/ l) kienu komuni ħafna.
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
4 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 5. 56 mmol/ l) li żdiedu għal għoljin (≥ 7 mmol/ l).
Changes in fasting glucose from borderline at baseline (≥ 5.56- < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Tibdil fil- livelli taz- zokkor waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 5. 56 - < 7 mmol/ l) għal għoljin (≥ 7m mol/ l) kienu komuni ħafna.
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
5 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 1. 69 mmol/ l) li żdiedu għal għoljin (≥ 2. 26 mmol/ l).
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/ l- < 2.26 mmol/ l) to high (≥ 2.26 mmol/ l) were very common.
Tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 69 mmol/ l - < 2. 26 mmol/ l) għal għoljin (≥ 2. 26 mmol/ l) kienu komuni ħafna.
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
6 studji kliniċi, l- inċidenza tal- marda ta 'Parkinson u distonja f' pazjenti kkurati b ’ olanzapine kienet P PFi
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Pazjenti kkurati b ’ olanzapine kellhom inċidenza tal- marda ta 'Parkinson, ta' l- akatiżja u tad- distonja aktar baxxa ikkumparata ma 'dożi titrati ta ’ haloperidol.
In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it can not be concluded at present that olanzapine produces less tardive dyskinesia and/ or other tardive extrapyramidal syndromes.
Fl- assenza ta 'tagħrif dettaljat dwar passat pri - ezistenti ta' disturbi akuti u movimenti tardivi ekstrapiramidali, fil- preżent ma jistax jiġi konkluż li olanzapine jipproduċi anqas diskineżja tardiva u/ jew sindromi ekstrapiramidali tardivi oħra.
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 Ġew irrapportati sintomi akuti bħal għaraq, insomnja, rogħda, ansjetà, tqalligħ u rimettar meta olanzapine jitwaqqaf f' daqqa.
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
8 Kienu rari l- manifestazzjonijiet kliniċi assoċjati (eż. ginekomastja, galaktorea, u tkabbir tas- sider).
In most patients, levels returned to normal ranges without cessation of treatment.
Fil- biċċa l- kbira tal- pazjenti, il- livelli reġgħu lura għan- normal mingħajr twaqqif ta 'kura.
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HCL cholesterol or triglycerides increased over time.
Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
F’ pazjenti adulti li spiċċaw 9- 12- il xahar ta ’ terapija, ir- rata taż- żieda fil- medja tal- glucose fid- demm naqset wara kważi 4- 6 xhur.
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).
Tagħrif addizzjonali dwar popolazzjonijiet speċjali 9 Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Reazzjonijiet avversi komuni ħafna assoċjati ma ’ l- użu ta’ olanzapine f’ dan il- grupp ta ’ pazjenti kienu mixi mhux normali u waqgħat.
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Il- pulmonite, iż- żieda fit- temperatura tal- ġisem, il - letarġija, l- eritema, l- alluċinazzjonijiet viżivi u l- inkontinenza ta ’ l- awrina kienu komunement osservati.
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’ s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Fi studji kliniċi f’ pazjenti b’ psikożi dovuta għal mediċina (agonist ta 'dopamine) assoċjata mal- marda ta ’ Parkinson, id- deterjorament fis- sintomi tal- marda ta ’ Parkinson u fl- alluċinazzjonijiet, kienu rrapportati b' mod komuni ħafna u aktar ta ’ spiss milli bil- plaċebo.
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 wieħed f' pazjenti b' manija bipolari, terapija b’ valproate flimkien ma 'olanzapine rriżultat f' inċidenza ta' newtropenja ta '4. 1%; fattur potenzjalment kontributorju jista' jkun livelli għolja ta ’ valproate fil- plażma.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
Olanzapine mogħti ma 'lithium jew valproate irriżulta f’ żieda fil- livelli (> 10%) ta' rogħda, nixfa fil- ħalq, żieda fl- aptit, u żieda fil- piż.
Speech disorder was also reported commonly.
Disturb fid- diskors kien ukoll komunement rappurtat.
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).
Waqt trattament b’ olanzapine flimkien ma ’ lithium jew divalproex, żieda ta '≥ 7% mil- linja bażi tal- piż tal- ġisem seħħet f' 17. 4% tal- pazjenti waqt it- trattament akut (sa 6 ġimgħat).
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
Trattament b’ olanzapine għal żmien twil (sa 12- il xahar) bl- għan ta 'prevenzjoni ta' episodju ieħor f' pazjenti b' mard bipolari kien assoċjat ma 'żieda ta' ≥ 7% mil- linja bażi tal- piż tal- ġisem f '39. 9% tal - pazjenti.
9 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Tfal u adolexxenti Olanzapine mhux indikat għall- użu fit- tfal u pazjenti adolexxenti taħt it- 18- il sena.
Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials.
Għalkemm ma ġewx imwettqa studji kliniċi magħmulin biex iqabblu l- adolexxenti ma 'l- adulti, informazzjoni mill - istudji ta' l- adolexxenti ġiet imqabbla ma 'dik ta ’ l- istudji ta' l- adulti.
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.
It- tabella li ġejja tiġbor fil- qosor ir- reazzjonijiet avversi rrapportati b' frekwenza akbar f' pazjenti adolexxenti (minn 13 sa 17- il sena) milli f' pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi ta ’ terminu qasir f' pazjenti adolexxenti.
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Żieda fil- piż klinikament sinifikanti (≥ 7%) tidher li sseħħ aktar frekwentement fil- popolazzjoni ta 'l- adolexxenti meta mqabbla ma ’ l - adulti li kellhom l- istess ammont ta ’ espożizzjoni għall- prodott.
The magnitude of weight gain and the propotion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
L- ammont ta ’ żieda fil- piż u l - proporzjon ta ’ pazjenti adolexxenti li kellhom żieda fil- piż klinikament sinifikanti kienu akbar b’ espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 24 ġimgħa) milli b’ espożizzjoni għal perijodu qasir ta’ żmien..
Very common (≥ 10%), common (≥ 1% and < 10%).
Komuni ħafna (≥ 10%), komuni (≥ 1% u < 10%).
Weight gain9, elevated triglyceride levels10, increased appetite.
Żieda fil- piż9, livelli elevati ta 'trigliċeridi10, żieda fl- aptit.
Elevated cholesterol levels11 Nervous system disorders Very common:
Livelli għolja ta 'kolesterol11 Disturbi fis- sistema nervuża Komuni ħafna:
Sedation (including: hypersomnia, lethargy, somnolence).
Sedazzjoni (inklużi: ipersomnja, letarġija, sedazzjoni, sonnolenza).
Dry mouth Hepato-biliary disorders Very common:
Ħalq xott Disturbi fil- fwied u fil- marrara Komuni ħafna:
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
Żieda ta 'transaminases tal- fwied (ALT/ AST; ara sezzjoni 4. 4).
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
Tnaqqis fil- bilirubin totali, żieda ta 'GGT, livelli elevati ta' prolactin fil- plażma12.
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
With long-term exposure (at least 24 weeks), approximately half of adolescent patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
B’ espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 24 ġimgħa) kważi nofs il- pazjenti adolexxenti żiedu ≥ 15% u kważi terz żiedu ≥ 25% mill- piż bażilari tagħhom.
Among adolescent patients, mean weight gain was greatest in patients who were overweight or obese at baseline.
Fost il- pazjenti adolexxenti, il- medja taż- żieda fil- piż kienet l- iżjed f’ pazjenti li bħala piż bażilari kellhom piż żejjed jew kienu obeżi.
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
10 10 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 1. 016 mmol/ l) li żdiedu għal għoljin (≥ 1. 467 mmol/ l) u tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) għal għoljin (≥ 1. 467 mmol/ l).
11 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/ l) to high (≥ 5.17 mmol/ l) were observed commonly.
11 Tibdil fil- livelli tal- kolesterol totali waqt is- sawm minn normal fil- linja bażi (< 4. 39 mmol/ l) għal għoljin (≥ 5. 17 mmol/ l) kienu komuni.
Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39- < 5.17 mmol/ l) to high (≥ 5.17 mmol/ l) were very common.
Tibdil fil- livelli tal- kolesterol totali waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 4. 39 - < 5. 17 mmol/ l) għal għoljin (≥ 5. 17 mmol/ l) kienu komuni ħafna.
12 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
12 F' 47. 4% tal- pazjenti adolexxenti ġew irrapportati livelli għoljin ta 'prolactin fil- plażma.
4.9 Overdose
Sinjali u sintomi U
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.
Sintomi komuni ħafna meta ittieħdet doża eċċessiva (> 10% inċidenza) jinkludu takikardija, aġitazzjoni/ aggressività, diżartrija, sintomi ekstrapiramidali varji, u telf tas- sensi li tvarja minn sedazzjoni sa koma.
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.
Sintomi oħra morbużi ta 'doża eċċessiva li huma medicament sinifikanti jinkludu d- delirju, il - konvulżjoni, koma, possibilment Sindromu Newrolettiku Malinn, depressjoni respiratorja, aspirazzjoni fil- passaġġ respiratorju, pressjoni tad- demm għolja jew baxxa, taħbit tal- qalb irregolari (< 2% tal - każijiet ta' doża eċċessiva) u arrest kardjopulmonari.
Fatal outcomes have been reported for acute overdoses as low as 450mg but survival has also been reported following acute overdose of 1,500 mg.
Ġew rappurtati każijiet fatali b 'dożi akuti u eċċessivi baxxi daqs 450 mg iżda kien hemm ukoll każ fejn pazjent baqa ħaj wara doża eċċessiva akuta ta' 1, 500 mg.
Management of overdose 10 There is no specific antidote for olanzapine.
Ma hemm ebda antidotu speċifiku għal olanzapine.
Induction of emesis is not recommended.
Remettar sfurzat mhux rakkomandat.
Standard procedures for management of overdose may be indicated (i. e. gastric lavage, administration of activated charcoal).
Jistgħu jkunu ndikati l- miżuri tas- soltu għall- immaniġar ta 'doża eċċessiva (li huma l- ħasil gastriku, teħid ta' faħam attivat).