qanastek/EMEA-V3 huggingface dataset:
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC)
Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC)
Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC) Blister (Al/ /OPA/ Al/ PVC)
Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC) Folja (Al // OPA/ Al/ PVC)
SUMMARY OF PRODUCT CHARACTERISTICS
SOMMARJU TAL- KARATTERISTIĊ TAL- PRODOTT I
Zalasta 2.5 mg tablets
Zalasta 2. 5 mg pilloli
Each tablet contains 2.5 mg olanzapine.
Kull pillola fiha 2. 5 mg olanzapine.
Each tablet contains 40.4 mg lactose.
Kull pillola fiha 40. 4 mg lactose.
For a full list of excipients, see section 6.1.
Għ al- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.
Il- pilloli huma tondi, xi ftit konvessi, jagħ fl- isfar possibbilment b' tikek sofor individwali. tu
4.1 Therapeutic indications
4. 1 Indikazzjonijiet terapewtiċ i
Adults Olanzapine is indicated for the treatment of schizophrenia.
Adulti Olanzapine hu indikat għ at- trattament ta 'l- iskiż ofrenija.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapine hu effettiv fiż amma ta 'titjib kliniku waqt it- terapija ta' kontinwazzjoni f' pazjenti li jkunu - ż wrew rispons inizjali għat- trattament.
Olanzapine is indicated for the treatment of moderate to severe manic episode.
Olanzapine hu indikat għ at- trattament ta 'episodji ta' manija minn moderati sa severi.
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).
olanzapine hu indikat għall- prevenzjoni tar- rikorrenza f' pazjenti bid- disturb bipolari (ara sezzjoni 5. 1).
4.2 Posology and method of administration
4. 2 Poż ija u metodu ta ’ kif għ
Adults Schizophrenia:
Skiżofrenija:
The recommended starting dose for olanzapine is 10 mg/ day.
Id- doż inizjali rrakkomandata għ olanzapine hi 10 mg kuljum.
Manic episode:
Episodji ta 'manija:
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
b' olanzapine biss jew 10 mg kuljum fil- każ terapija b' olanzapine flimkien ma 'mediċ oħ (ara sezzjoni 5. 1).
Preventing recurrence in bipolar disorder:
Prevenzjoni tar- rikorrenzata ’ disturb bipolari:
The recommended starting dose is 10 mg/ day.
Għ
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Jekk ikun hemm episodju ġ ta 'manija,
If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
dipressjoni jew taħ tat- tnejn, it- trattament b' olanzapine għ
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5- 20 mg/ day.
ottima kif meħ), b' terapija supplimentari għ klinikament.
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
at- trattament tas- sintomi tal- burdata, kif indikat
2 Olanzapine can be given without regards for meals as absorption is not affected by food.
2 Waqt it- trattament għ
Gradual tapering of the dose should be considered when discontinuing olanzapine.
kuljum tista 'tiġ sussegwentement aġustata skond l- istat kliniku individwali bejn 5 u 20 mg kuljum.
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.
Meta jkun sa jitwaqqaf it- trattament, wieħ għed andu jikkunsidra t- tnaqqis tad- doż bil- mod il- mod. a
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
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
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).
dawk li jkollhom 65 sena jew iktar meta xi fatturi kliniċjitolbu dan (ara wkoll sezzjoni 4. 4). i
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
F' każ ta 'insuffiċ
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.
andha tkun ta '5
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
andhomx jinbidlu skond jekk il- pazjenti jkunux irġ jew nisa. iel
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
andhomx jinbidlu skond jekk il- pazjenti jkunux ipejpu.
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.
li jista 'jnaqqas il- metaboliż (pazjenti nisa, pazjenti anzjani,
Dose escalation, when indicated, should be conservative in such patients.
Għ dawn il- pazjenti, meta jkun indikat, id- doż għ a andha tiż b' moderazzjoni. died
(See sections 4.5 and 5.2.)
(Ara sezzjonijiet 4. 5 u 5. 2.)
Hypersensitivity to the active substance or to any of the excipients.
ċ Sensittività eċessiva għ as- sustanza attiva jew għ xi sustanzi mhux attivi. al
Patients with known risk for narrow-angle glaucoma.
Pazjenti b' riskju magħ għ ruf all- glawkoma.
4.4 Special warnings and precautions for use
4. 4 Twissijiet speċ u prekawzjonijiet għ
During antipsychotic treatment, improvement in the patient's clinical condition may ta ke several days to some weeks.
Waqt trattament bl- antipsikotiċ titjib fil- kundizzjoni klinika tal- pazjent għ
Patients should be closely monitored during this period.
andhom jiġ monitorjati sew waqt dan il- perjodu. u
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.
Psikożrelatata mad- demenzja u/ jew disturbi fil- komportament i Olanzapine mhux approvat għ
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
all- uż f’ dan il- grupp partikolari ta ’ pazjenti, dovut għ ż komportament,
1.5%, respectively).
erebro- vaskulari.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
kkontrollati bil- plaċ (li damu i ebo
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.
), 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.
demenzja u/ jew disturbi fil- komportament, kien hemm ż ta ’ darbtejn akbar fl- inċ
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
L- inċ
There was a 3-fold increase in CVAE in patients treated
idenza ogħ ta ’ l- imwiet ma kienitx assoċ mad- doż ta ’ olanzapine (doż medja la jata a
3 with olanzapine compared to patients treated with placebo (1.3% vs.
3
0.4%, respectively).
puplesija,
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Kien hemm ż ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti
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 imħ
The efficacy of olanzapine was not established in these trials.
L -
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- uż ta' olanzapine fit- trattament tal- psikożassoċ ma 'l- agonisti ta ’ dopamine
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 kliniċ id- deterjorament fis- sintomi tal- marda ta ’ i, inazzjonijiet kienu rrappurtati b’ mod komuni ħ u aktar ta 'spiss milli bil- plaċ (ara Parkinson u alluċ
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.
kontra l- marda ta ’ Parkinson (agonist ta ’ dopamine) u biex jibqgħ fuq l- istess mediċ u dożkontra l -
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
urnata u ż bil- mod għ marda ta ’ Parkinson matul l- istudju. ta '15 mg/ ġ urnata ibbaż fuq il- ġ
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 assoċ ma' prodotti mediċ antipsikotiċ Każ rari li ġ rappurtati bħ NMS kienu rrappurtati f' assoċ
Rare cases reported as NMS have also been received in association with olanzapine.
jazzjoni 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).
instabbiltà awtonomika (pressjoni tad- demm jew tal- polz irregolari, takikardija, dijaforeż u taħ tal -
Additional 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
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.
NMS, jew ikollu deni għ bla ebda spjegazzjoni u mingħ manifestazzjonijiet kliniċoħ ta 'NMS,
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
F' xi każ qabel kien hemm
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Għ i
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.
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.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
Tibdil fil- livell tal- lipidi għ
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
jalment f’ pazjenti b’ ammonti mhux normali ta ’ lipidi fid- demm u f’ pazjenti li
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Meta olanzapine wera attività antikolinerġ in vitro, l- esperjenza waqt l - istudji kliniċ wriet
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.
jippreskrivi għ pazjenti bi prostata kbira, jew paralytic ileus u kundizzjonijiet relatati. al
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Għ
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 medicines.
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
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
Fil- każ ALT u/ jew AST elevati waqt it- trattament, wieħ għ
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
(inkluż epatoċ ellulari, kolestatika jew korriment imħ tal- fwied), it- trattament b' olanzapine għ jitwaqqaf.
4 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.
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
In- newtropenja kienet ukoll irrappurtata i komunement meta olanzapine u valproate ntuż flimkien (ara sezzjoni 4. 8). aw
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.
al araq, insomnja, rogħ ansjetà, tqalligħ da,,
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.
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
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
i ra, andha tittieħ kawtela meta olanzapine jingħ ma 'mediċ oħ li huma magħ li jż l- intervall QTc, speċ
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
B’ mod rari ħ (< 0. 01%) ġ irrapportata assoċ
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Madankollu peress li pazjenti b’ skizofrenija ħ drabi jippreż b’ fatturi ta ’ riskju
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.
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.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Minħ abba l- effetti primarji ta 'olanzapine fuq is- CNS għandha tittieħ kawtela meta dan jingħ flimkien ma' mediċ oħ li jaġ
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
antagoniż għ dopamine, olanzapine jista 'jantagonizza l- effetti diretti u indiretti ta' l- agonisti ta ’ mu al 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.
b' kawtela f' pazjenti li jkollhom storja ta 'aċessjonijiet jew li jkunu suġetti a ċ ċ
Seizures have been reported to occur rarely in patients when treated with olanzapine.
F' ħ mill- każ kienu rappurati fatturi ta 'riskju għ
In most of these cases, a history of seizures or risk factors for seizures was reported.
jew storja ta 'aċessjonijiet.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
5 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
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.
b' esponiment fit- tul, u għ alhekk jekk jitfaċaw sintomi ta 'diskajneż tardiva f' pazjenti li jkunu qed jieħ olanzapine, wieħ għ
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
ansitra jitfaċaw wara li jitwaqqaf it- trattament.
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.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
tibda titkejjel perjodikament fil- pazjenti ta 'iktar 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.
Studji f' pazjenti bejn it- 13 u s- 17- il sena u
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
wrew reazzjonijiet avversi varji, fosthom ż fil- piżtibdil fil- parametri metaboliċu ż fil- livelli ta '
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 assoċ ma 'dawn l- avvenimenti ma ġ studjati u għ (ara sezzjonijiet 4. 8 u 5. 1).
5 Lactose Zalasta tablets contain lactose.
4. 5 Prodotti mediċinali oħ li ma jaqblux ma ’ dan il- prodott u affarijiet oħ li jistgħ jibdlu l -
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Interazzjonijiet potenzjali li jaffettwaw olanzapine Billi olanzapine jiġmetabolizzat bis- CYP1A2, sustanzi li speċ
4.5 Interaction with other medicinal products and other forms of interaction
ifikament jinduċ jew jinibixxu dan l - u
Interaction studies have only been performed in adults.
isoenzim jistgħ jaffettwaw il- farmakokinetika ta 'olanzapine. u
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.
Induzzjoni ta 'CYP1A2 Il- metaboliż ta' olanzapine jista 'jiġindott mit- tipjip u minn carbamazepine, li jista' jwassal għ
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Ġ osservata biss ż ħ
Only slight to moderate increase in olanzapine clearance has been observed.
olanzapine.
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 kliniċaktarx li huma limitati, iż hu rakkomandat li ssir sorveljanza klinika
Inhibition of CYP1A2 Fluvoxamine, a specific CYP 1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Inibizzjoni tas- CYP1A2 Intwera li fluvoxamine, inibitur speċ ifiku tas- CYP 1A2, jinibixxi b' mod sinjifikanti l- metaboliż ta 'mu olanzapine.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Iż ieda medja f' olanzapine (Cmax) wara l- għ ta 'fluvoxamine kienet ta' 54% fin- nisa li ma
The mean increase in olanzapine AUC was 52% and 108% respectively.
Iż ieda medja f' olanzapine AUC kienet ta ’ 52% u 108%
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Għ
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP 1A2 is initiated.
tnaqqis fid- doż ta 'olanzapine jekk ikun inbeda trattament b' inibitur tas- CYP 1A2. 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.
Tnaqqis fil- bijodisponibilità Il- faħ attivat inaqqas il- bijodisponibilità ta 'olanzapine orali b' bejn 50 u 60% u għ
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
6 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.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Olanzapine jista 'jantagonizza l- effetti ta' agonisti diretti u indiretti tad- dopamina.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Olanzapine ma jinibixxix l- isoenzimi CYP450 ewlenin in vitro (per eż
1A2, 2D6, 2C9, 2C19, 3A4).
empju 1A2, 2D6, 2C9, 2C19,
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).
jirrappreżentaw s- sekwenza CYP2D6), warfarin (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Olanzapine ma wera l- ebda interazzjoni meta ngħ flimkien mal- litju jew biperiden. ata
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.
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 Għ andha tittieħ kawtela f' pazjenti li jixorbu l- alkoħ jew li jieħ prodotti mediċ li jistgħ
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- uż konkomitanti ta 'olanzapine ma' prodotti mediċ kontra l- Parkinson f' pazjenti bil- marda ta 'Parkinson
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
jtawwlu l- intervall QTc (ara sezzjoni 4. 4).
There are no adequate and well-controlled studies in pregnant women.
M' hemmx studji adegwati u kkontrollati tajjeb fin- nisa tqal.
Patients should be advised to notify their physician if they become 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
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, billi l- esperjenza fil- bniedem hi limitata, fit- tqala, olanzapine għ andu jintuż a
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.
evuti rapporti spontanji ħ ta 'rogħ ipertonija, letarġ u ngħ qawwi, fi tfal ż ar Kienu riċ
Lactation:
afna
In a study in lactating, healthy women, olanzapine was excreted in breast milk.
imwellda minn ommijiet li kienu ħ olanzapine matul it- tielet trimestru. adu
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
L- esponiment medju (mg/ kg) tat- trabi kien bejn wieħ u ieħ ta ’ 1. 8% tad- doż ta 'olanzapine fl -
Patients should be advised not to breast feed an infant if they are taking olanzapine.
Il- pazjenti għandhom jingħ olanzapine.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħ biex issuq u tħ
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħ biex issuq u tħ
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Billi olanzapine jista 'jikkawż ngħ u sturdament, il- pazjenti għ
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.
eridi (ara sezzjoni 4. 4), glukosurja, ż fl- aptit, għ ta 'prolactin, kolesterol, glucose u trigliċ
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
antikolinerġ i, ż fil- livelli tat- transaminases tal- fwied li ma jurux sintomi u li huma momentanji (ara iċ ieda sezzjoni 4. 4), raxx, astenja, għ u edima. eja
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
L- effetti li huma l- aktar serji tniżlu l- ewwel, segwiti minn dawk anqas serji.
The frequency terms listed are defined as follows:
It- termini ta 'frekwenza elenkati huma mfissra kif ġ Komuni ħ (> 10%), komuni (> 1% u <
Very common (≥
afna
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
10%), mhux komuni (> 0. 1% u < 1%), rari (> 0. 01% u < 0. 1%), rari ħ (< 0. 01%), mhux magħ (ma jistgħ jiġ stmati mill- informazzjoni li hemm disponibbli). ux u
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Komuni ħ afna Komuni Mhux komuni Disturbi tad- demm u tas- sistema limfatika
Very common
Mhux magħrufa
Common
Ż
Uncommon
olja
Not known
vilupp jew iggravar
Blood and the lymphatic system disorders Immune system disorders
kolesterol2, 3 Livelli għ ta '
Eosinophilia
tad- dijabete, xi kultant
Leukopenia Neutropenia
assoċ ma ’ jata
Thrombocytopenia Allergic reaction
glucose4 Livelli għ ta '
Metabolism and nutrition
ketoaċ i jew koma idoż
disorders
olja trigliċ 2, 5
Weight gain1
inklużxi każ fatali i ijiet
Elevated cholesterol levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
(ara sezzjoni 4. 4) Ipotermija
Nervous system disorders Somnolence
Disturbi fis- sistema nervuż a ċ Sonnolenza
Dizziness Akathisia6
Sturdament
Seizures where in most cases a history of
Aċessjonijiet li fil - ġ
Cardiac disorders
Akatizja6 Parkinsoniż Diskineż 6
Parkinsonism6 Dyskinesia 6
6 mu
seizures or risk factors 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
Bradycardia QT c prolongation (see section 4.4)
Bradikardija QT c imtawwal (ara sezzjoni 4. 4)
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Takikardija / fibrillazzjoni ventrikulari, mewt għ għall - arrieda (ara sezzjoni 4. 4)
Orthostatic hypotension
Pressjoni waqfien
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Tromboemboliż mu (inkluż l- emboliż mu pulmonari u t- tromboż i tal- vini fil- fond)
Mild, transient anticholinergic effects including constipation and dry mouth
Effetti antikolinerġ i iċ ħ u li jgħ fief addu malajr inkluż i stitikezza u ħ xott alq
Hepato-biliary disorders
Ż ieda ta 'transaminases
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
tal- fwied (ALT, AST)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
malajr, speċ bidu tal- kura sezzjoni 4. 4)
Skin and subcutaneous tissue disorders
kolestatiku jew tat - tnejn flimkien)
Photosensitivity reaction Alopecia
ilda Reazzjoni ta 'fotosensittività Alopeċ ja
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
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
High creatine phosphokinase Increased total bilirubin
phosphokinase għ
Clinically significant weight gain was observed
Ż ieda fil- bilirubin totali
across all baseline Body Mass
isem (Body
Index (BMI)
Mass Index - BMI), fil- kategoriji kollha.
categories.
komuni ħ
Weight gain ≥ 7% of baseline body weight was very common and ≥
u ta ’ ≥ afna
15% of baseline body
15% mil- linja bażtal- piż
weight was common.
mijiet.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
Innotat għ livelli normali waqt is- sawm fil- linja baż (< 5. 17 mmol/ l) li ż 3
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
6. 2 mmol/ l).
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
Tibdil fil- livelli tal- kolesterol totali waqt is- sawm mil- limitu tan- normal fil- linja baż( ≥ i al oljin (≥6. 2 mmol/ l) kienu komuni ħ 5. 17 mmol/ l - < 6. 2 mmol/ l) għ għ
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 al oljin (≥7m mol/ l) kienu komuni ħ 7 mmol/ l) għ għ afna.
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
9 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
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 baż( ≥1. 69 mmol/ l - < i 2. 26 mmol/ l) kienu komuni ħ 2. 26 mmol/ l) għ għ 6
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
numerikament ogħ imma statistikament mhux differenti b’ mod sinifikattiv mill- plaċ Pazjenti
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Fl- assenza ta 'tagħ dettaljat dwar passat pri- ezistenti ta'
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.
disturbi akuti u movimenti tardivi ekstrapiramidali, fil- preż ma jistax jiġ konkluż olanzapine
7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Ġ irrapportati sintomi akuti bħ għ 7 ew al araq, insomnja, rogħ ansjetà, tqalligħ rimettar meta olanzapine jitwaqqaf f' daqqa.
In most patients, levels returned to normal ranges without cessation of treatment.
Fil -
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.
allinqas 48
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
terapija, ir- rata taż ieda fil- medja tal- glucose fid- demm naqset wara kważ4- 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).
ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċ (ara wkoll sezzjoni 4. 4). ebo Reazzjonijiet avversi komuni ħ assoċ ma ’ l- uż ta’ olanzapine f’ dan il- grupp ta ’ pazjenti kienu mixi
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
mhux normali u waqgħ Il- pulmonite, iż ieda fit- temperatura tal- ġ
Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
alluċinazzjonijiet viż u l- inkontinenza ta ’ l- awrina kienu komunement osservati. ivi
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.
Fi studji kliniċf’ pazjenti b’ psikożdovuta għ mediċ (agonist ta 'dopamine) assoċ mal- marda ta ’
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
Olanzapine administered with lithium or valproate resulted in increased levels ( 10%) of tremor, dry mouth, increased appetite, and weight gain.
f' inċidenza ta 'newtropenja ta' 4. 1%; fattur potenzjalment kontributorju jista 'jkun livelli għ ta ’ olja valproate fil- plaż Olanzapine mogħ ma' lithium jew valproate irriż f’ ż fil- livelli (> 10%) ta '
Speech disorder was also reported commonly.
rogħ nixfa fil- ħ ż fl- aptit, u ż fil- piżDisturb 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, ż ta '≥7% mil- linja bażtal- piż
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.
Trattament b’ olanzapine għ ħ tal- ġ
9 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Għ imwettqa studji kliniċmagħ
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.
mulin biex iqabblu l- adolexxenti ma 'l- adulti, informazzjoni mill- istudji ta' l -
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.
Ż
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
ieda fil- piżklinikament sinifikanti (≥7%)
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
ta ’ ż allinqas 24 ġ
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa tniżlu skond is- serjetà tagħhom.
The frequency terms listed are defined as follows:
It- termini ta 'frekwenza elenkati huma mfissra kif ġ Komuni ħ
Very common (≥ 10%), common (≥ 1% and < 10%).
afna (≥10%), komuni (≥1% u < 10%).
Metabolism and nutrition disorders Very common:
Disturbi fil- metaboliż u n- nutrizzjoni mu Komuni ħ afna:
Weight gain9, elevated triglyceride levels10, increased appetite.
9
11 Common:
Livelli għ ta 'kolesterol 11 olja Disturbi fis- sistema nervuż
Elevated cholesterol levels Nervous system disorders Very common:
Komuni ħ afna:
Sedation (including: hypersomnia, lethargy, somnolence).
Sedazzjoni (inkluż ipersomnja, letarġ sedazzjoni, sonnolenza).
Dry mouth Hepato-biliary disorders Very common:
Komuni ħ afna:
Elevations of hepatic transaminases (ALT/ AST; see section 4.4).
Ż ieda ta 'transaminases tal- fwied (ALT/ AST; ara sezzjoni 4. 4).
Investigations Very common:
Investigazzjonijiet Komuni ħ afna:
Decreased total bilirubin, increased GGT, elevated plasma prolactin levels12.
Tnaqqis fil- bilirubin totali, ż ta 'GGT, livelli elevati ta' prolactin fil- plaż 12.
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
Ż fil- piż ≥7% mil- linja bażtal- piż isem (kg)
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.
nofs il- pazjenti adolexxenti ż ≥15% u kważterz ż ≥
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
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).
(≥1. 467 mmol/ l) u tibdil fit- trigliċ eridi waqt is- sawm mil- limitu tan- normal fil- linja baż( ≥1. 016 mmol/ l i
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 baż (< 4. 39 mmol/ l) għ
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 - al oljin (≥5. 17 mmol/ l) kienu komuni ħ normal fil- linja baż( ≥4. 39 - < 5. 17 mmol/ l) għ għ
12 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
F' 47. 4% tal- pazjenti adolexxenti ġ irrapportati livelli għ 12
4.9 Overdose
4. 9 Doż eċessiva
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.
idenza ta 'iktar minn 10%) jinkludu t- takikardija,
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.
baxxa, ritmi irregolari tal- qalb (li jseħu f' iktar minn 2% tal- każ ta 'doż eċessiva) u waqfien tal - ijiet iċ funzjoni tal- qalb u tal- pulmun.
Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of 1,500 mg.
Kien hemm rapporti ta 'konsegwenzi fatali anke b' dożeċessivi ta' 450 mg iċ biss iż kien hemm rapporti ta 'sopravivenza anke minn dożeċessivi ta' 1, 500 mg. da
10 Management of overdose There is no specific antidote for olanzapine.
iċ Il- ġestjoni ta 'dożeċessivi Ma hemm l- ebda antidotu speċ għ olanzapine.
Induction of emesis is not recommended.
Jistgħ
Standard procedures for management of overdose may be indicated (i. e. gastric lavage, administration of activated charcoal).
Intwera li l- amministrazzjoni tal- faħ attivat tista 'tnaqqas il -
The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
bijodisponibilità orali b' bejn 50 u 60%.