FrancophonIA/ELRC3.0 huggingface dataset:
English: 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, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Maltese: Fi studji kliniċi, l-aktar reazzjonijiet avversi li ġew irrapportati b'mod frekwenti (jidhru f'> 1% talpazjenti) 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 taqsima 4.4), glukosurja, żieda fl-aptit, sturdament, akatiżja, parkinsoniżmu, lewkopenija, newtropenija (ara taqsima 4.4), diskineżja,
English: In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr).
Maltese: F'pazjenti li ma jpejpux f'paragun ma' dawk li jpejpu (irġiel u nisa) il-medja tal-half life ta' l eliminazzjoni kien imtawwal (38.6 kontra 30.4 siegħa) u l-clearance tnaqqset (18.6 kontra 27.7 l/hr).
English: Olazax Disperzi 5 mg orodispersible tablets Olazax Disperzi 7.5 mg orodispersible tablets Olazax Disperzi 10 mg orodispersible tablets Olazax Disperzi 15 mg orodispersible tablets Olazax Disperzi 20 mg orodispersible tablets Olanzapine
Maltese: Olazax Disperzi 5 mg pilloli li jinħallu fil-ħalq Olazax Disperzi 7.5 mg pilloli li jinħallu fil-ħalq Olazax Disperzi 10 mg pilloli li jinħallu fil-ħalq Olazax Disperzi 15 mg pilloli li jinħallu fil-ħalq Olazax Disperzi 20 mg pilloli li jinħallu fil-ħalq
English: MARKETING AUTHORISATION HOLDER Glenmark Pharmaceuticals s.r.o.
Maltese: Manifattur Glenmark Pharmaceuticals s.r.o.
English: Olazax Disperzi orodispersible tablet contains aspartame, which is a source of phenylalanine.
Maltese: Olanzapine Glenmark pillola fiha aspartame, li huwa sors ta' phenylalanine.
English: Elevated glucose levels4
Maltese: glucose4
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Maltese: Fi studji sa 3 xhur fil-ġrieden u sa sena fil-firien u fil-klieb, l-effetti li ippredominaw kienu d depressjoni CNS, effetti antikolinerġiċi, u diżordnijiet periferali ematoloġiċi.
English: In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0 %, lithium 38.3 %; p = 0.055).
Maltese: Fit-tieni studju ta' 12-il xhar dwar ir-rikorrenza preventiva f'pazjenti b'episodju ta' manija li kienu ikkontrollati b'olanzapine u l-lithium flimkien, kienu mbagħad mqassmin mingħajr għażla u mogħtija olanzapine jew il-lithium waħdu. olanzapine kien statistikament mhux inferjuri għall-lithium fuq lgħan ewlieni ta' rikorrenza bipolari (olanzapine 30.0%, lithium 38.3%; p = 0.055).
English: Discontinuati on symptoms7, 12
Maltese: Sintomi ta' twaqqif tal-kura7,12
English: QTc prolongation (see section 4.4)
Maltese: Bradikardija QTc imtawwal (ara taqsima 4.4)
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Maltese: Olanzapine wera affinità akbar in vitro għar-riċetturi ta' serotonin 5-HT2 milli ta' dopamine D2 u attività in vivo akbar għal 5-HT2 milli għal D2.
English: A mass balance study showed that approximately 57 % of radiolabelled olanzapine appeared in urine, principally as metabolites.
Maltese: 57% ta' olanzapine radjuattiv fl-urina, prinċipalment bħala prodotti metaboliċi.
English: Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Maltese: aminotransferases talfwied (ALT, AST) bla sintomi u li tgħaddi malajr, speċjalmet fil bidu tal-kura (ara taqsima 4.4)
English: In renally impaired patients (creatinine clearance < 10 ml/min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0
Maltese: ma kienx hemm differenza sinifikanti fil-medja tal-half life ta' l-eliminazzjoni (37.7 kontra 32.4 siegħa) jew il-clearance (21.2 kontra 25.
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Maltese: trigliċeridi, u prolactin (ara taqsimiet 4.4 u 4.8) kien akbar fl-adolexxenti milli fl-adulti.
English: Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Maltese: Fluvoxetine (inibitur CYP2D6), dożi b'waħdiet t' antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il-komportament farmakokinetiku ta' olanzapine.
English: Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Maltese: Studji fuq l-imġiba ta' l-annimali b'olanzapine indikaw antagoniżmu għal 5HT, dopamine, u dak kolinerġiku, konsistenti mal-profil ta' rbit mar-riċettur.
English: Olazax Disperzi 15 mg orodispersible tablets
Maltese: Olazax Disperzi 15 mg:
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α 1 adrenergic; and histamine H1 receptors.
Maltese: Fi studji ta' qabel l-użu kliniku, olanzapine wera firxa ta' affinitajiet għar-riċetturi (Ki; < 100 nM) għal riċetturi ta' serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; riċetturi muskariniċi kolinerġiċi M1-M5; α-1 adrenerġiċi; riċetturi histamine H1.
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (- 6.0) versus haloperidol (- 3.1).
Maltese: F'studju komparattiv,double-blind u multinazzjonali ta' skiżofrenija, ta' manifestazzjonijiet skiżoaffettivi u disturbi relatati oħra li kien jinkludi 1,481 pazjent li kellhom gravità differenti ta' l assoċjati sintomi dipressivi (medja ta' punteġg ta' 16.6 meħud fil-bidu tal-kura skond l-iskala li tivvaluta d-dipressjoni ta' Montgomery-Asberg), analiżi prospettiva sekondarja tat-tibdil fil-punteġġ ta'
English: Respiratory, thoracic and mediastinal disorders Epistaxis9
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: A small study of the effect of impaired liver function in 6 subjects with clinically significant (Childs Pugh Classification A (n = 5) and B (n = 1)) cirrhosis revealed little effect on the pharmacokinetics of orally administered olanzapine (2.5 - 7.5 mg single dose): Subjects with mild to moderate hepatic dysfunction had slightly increased systemic clearance and faster elimination half-time compared to subjects with no hepatic dysfunction (n = 3).
Maltese: Studju żgħir dwar l-effett ta' indeboliment fil-funzjoni tal-fwied f'6 suġġetti b'ċirrożi klinikament sinifikanti (Klassifikazzjoni Childs Pugh A (n = 5) u B (n = 1)) wera effett minimu fuq il farmakokinetika ta' olanzapine (2.5 - 7.5 mg bħala doża waħda) mogħti b;mod orali: Suġġetti b'disfunzjoni epatika ħafifa għal moderata kellhom żieda żgħira fit-tneħħija sistemika u half-time ta' eliminazzjoni aktar mgħaġġla meta mqabbla ma' suġġetti li ma kellhom ebda disfunzjoni epatika (n = 3).
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering, slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Maltese: Effetti sekondarji mhux komuni ( jistgħu jaffettwaw sa 1 minn kull 100 persuna) jinkludu sensittività eċċessiva (eż. nefħa fil-ħalq u l-gerżuma, ħakk, raxx); dijabete jew dijabete li tmur għall-agħar, kultant assoċjata ma' ketoaċidożi (ketoni fid-demm u fl-awrina) jew koma; aċċessjonijiet, normalment assoċjati ma' storja ta' aċċessjonijiet (epilessija); ebusija tal-muskoli jew spażmi (inklużi movimenti fl għajnejn); sindrome ta' saqajn irrekwieti; problemi fil-mod kif titkellem; temtim; il-qalb tħabbat bil mod; sensittività għad-dawl tax-xemx; tinfaraġ; l-addome jintefaħ; titlef il-memorja jew tibda tinsa; inkontinenza urinarja; nuqqas ta' kapaċità li tgħaddi l-urina; jaqa' x-xagħar; nuqqas ta' jew tnaqqis filmestrwazzjoni u tibdil fis-sider fl-irġiel u fin-nisa bħal produzzjoni mhux normali ta' ħalib mis-sider jew tkabbir mhux normali.
English: Musculoskeletal and connective tissue disorders Arthralgia9
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr).
Maltese: F'anzjani b'saħħithom (65 u fuqhom) f'paragun ma' pazjenti mhux anzjani, il-half life ta' leliminazzjoni medja twalet (51.8 paragun ma' 33.8 siegħa) u t-tneħħija tnaqqset (17.5 paragun ma'
English: 13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Maltese: 13 Wara kura għal żmien qasir (medjan ta' tul ta' żmien ta' 22 ġurnata), żieda fil-piż ta' > 7% mil-linja bażi tal-piż tal-ġisem (kg) kienet komuni ħafna (40.6 %), ≥ 15% mil-linja bażi tal-piż tal-ġisem kienet komuni (7.1 %) u ≥ 25 % kienet komuni (2.5 %).
English: Other medicines and Olazax Disperzi
Maltese: Mediċini oħra u Olazax Disperzi:
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Maltese: Disturbi fis-sistema nervuża Komuni ħafna: Sedazzjoni (inklużi: ipersomnja, letarġija, sonnolenza).
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with betaagonist activity since beta stimulation may worsen hypotension.
Maltese: Tużax epinephrine, dopamine, jew sustanzi oħra simpatomimatiċi b' attività beta-agonista għax listimulazzjoni beta tista' taggrava l-pressjoni baxxa.
English: Systemic Symptoms (DRESS)
Maltese: Sintomi Sistemiċi
English: How to store Olazax Disperzi
Maltese: Tiħux Olazax Disperzi:
English: High Gamma Glutamyltransferase 10 High Uric Acid 10
Maltese: Glutamyltransferase għoli10
English: Olazax Disperzi contains the active substance olanzapine.
Maltese: - Is-sustanza attiva hi olanzapine.
English: NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 7.5 mg orodispersible tablets
Maltese: Olazax Disperzi 7.5 mg:
English: Dementia-related psychosis and/or behavioural disturbances
Maltese: Psikożi relatata mad-demenzja u/jew disturbi fil-komportament
English: Dizziness Akathisia 6
Maltese: Sonnolenza Sturdament Akatizja6
English: Abdominal distension9
Maltese: Artralġja9
English: 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.
Maltese: 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.
English: Ventricular tachycardia/fibri llation, sudden death (see section 4.4)11
Maltese: Takikardija/ fibrillazzjoni ventrikulari, mewt għall għarrieda (ara taqsima 4.4)11
English: If this happens, contact your doctor at once.
Maltese: Aċċessjonijiet li filmaġġoranza tagħhom kien rrappurtat passat mediku ta'
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu
English: 4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Maltese: 4 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 5.56 mmol/l) li żdiedu għal għoljin (≥
English: Estrous cycles were affected at doses of 1.1 mg/kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/kg (9 times the maximum human dose).
Maltese: Iċ-ċikli estruwi kienu affettwati b'dożi ta' 1.1 mg/kg (3 darbiet id-doża massima fil bniedem) u l-parametri tar-riproduzzjoni kienu influwenzati fil-firien mogħtija 3 mg/kg (9 darbiet id doża massima fil-bniedem).
English: 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).
Maltese: Għalhekk, ma hemm ebda reazzjoni partikolari mistennija kif verifikat minn studji in vivo 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
English: Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) jinkludu tibdil fil-livelli ta' xi ċelluli tad-demm, ta' xaħmijiet fiċ-ċirkolazzjoni u kmieni fil-kura, żidiet temporanji tal-enzimi tal fwied; żidiet fil-livelli ta' zokkor fid-demm u fl-awrina; żidiet fil-livelli tal-aċidu uriku u tal-creatine phosphokinase fid-demm; tħossok aktar bil-ġuħ; sturdament; irrekwitezza; rogħda; movimenti mhux tas-soltu (diskajnisjas); stitikezza; ħalq xott; raxx; titlef il-forzi;għeja estrema; retenzjoni tal-ilma li twassal għal nefħa fl-idejn, għekiesi jew saqajn; deni; uġigħ fiġ-ġogi u disfunzjonijiet sesswali bħal tnaqqis fil-libido fl-irġiel u fin-nisa jew disfunzjoni erettili fl-irġiel.
English: Stuttering11Restless legs syndrome
Maltese: Temtim11Sindrome ta' Saqajn Irrekwieti
English: Smoking
Maltese: KARTUNA
English: Urinary incontinence, urinary retention Urinary hesitation11
Maltese: żamma tal-urina Eżitazzjoni urinarja11
English: 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.
Maltese: Fi studji kliniċi, id-deterjorament fis-sintomi tal-marda ta'Parkinson u l-alluċinazzjonijiet kienu rrappurtati b'mod komuni ħafna u aktar ta' spiss milli bilplaċebo (ara taqsima 4.8), u olanzapine ma kienx aktar effettiv mill-plaċebo fit-trattament tas-sintomi psikotiċi.
English: There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3 % verses 0.4 %, respectively).
Maltese: f'pazjenti ttattati b'olanzapine, meta mqabblin ma' pazjenti ttrattati bil-plaċebo (1.3% kontra 0.4%,
English: Crospovidone
Maltese: Glikosurja
English: Very rare side effects (may affect up to 1 in 10,000) include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Maltese: Effetti sekondarji rari ħafna jinkludu reazzjonijiet allerġiċi serji bħal Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS).
English: 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.
Maltese: 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.
English: Urinary incontinence, urinary retention
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Inkontinenza urinarja,
English: 4.8 Undesirable effects
Maltese: X'effetti oħra possibbli
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels (see sections 4.8 and 5.1).
Maltese: 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 (ara taqsimiet 4.8 u 5.1).
English: NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 20 mg orodispersible tablets
Maltese: Olazax Disperzi 20 mg:
English: Thrombocyto penia11
Maltese: Tromboċitopenija11
English: In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Maltese: Fi studju ta' 18-il xhar f'pazjenti b'manija jew b'episodji mħallta stabilizzati fuq olanzapine flimkien ma' stabilizzatur tal-burdata (lithium jew valproate), l-użu fit-tul ta' olanzapine flimkien ma' lithium jew l-valproate ma kienx statistikament sinifikanti superjuri għall-lithium jew għall-valproate waħdu biex jittardja r-rikorrenza bipolari, kif definit skond il-kriterji (dijanjostiċi) tas-sindromu.
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Maltese: Olanzapine jista' jantagonizza l-effetti ta' l-antagonisti ta' dopamine diretti jew indiretti.
English: Excipient with known effect: Each orodispersible tablet contains 0.23 mg aspartame For the full list of excipients see section 6.1
Maltese: Kull pillola li tinhall fil-ħalq fiha 0.23 mg ta' aspartame Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Maltese: tromboċitopenja jew l-anemija riversibbli żviluppaw fi ftit klieb ittrattati b' 8 jew 10 mg/kg/ġurnata (espożizzjoni totali ta' olanzapine [erja taħt il-kurva] hija 12 sa 15-il darba aktar minn dik ta' raġel mogħti doża ta' 12 mg).
English: Age > 75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Maltese: 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.
English: Olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.
Maltese: Olanzapine nbeda b' 2.5 mg/ġurnata u żdied bil-mod għall-massimu ta' 15 mg/ġurnata ibbażat fuq il-ġudizzju tar-riċerkatur.
English: 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.
Maltese: F'każijiet ta' insuffiċjenza tal-fwied moderata (ċirrożi, Child-Pugh Klassi A jew B), id-doża tal-bidu għandha tkun 5 mg u tiżdied biss b'kawtela.
English: Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Maltese: Olanzapine wera wkoll riżultati effikaċji li jistgħu jiġu kumparati ma' haloperidol fit termini tal-proporzjon ta' pazjenti f'remissjoni sintomatika minn manija u depressjoni f' 6 u 12-il ġimgħa.
English: (including oculogyration)11
Maltese: (ara taqsima 4.4)11
English: Amenorrhea Breast enlargement Galactorrhea in females Gynaecomasti a/breast enlargement in males
Maltese: Espożizzjoni għal perijodu twil ta' żmien (għallinqas 48 ġimgħa)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 7.5 mg orodispersible tablets Olanzapine STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 7.5 mg olanzapine.
English: 6.4 Special precautions for storage Store below 30 C.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen f'temperatura ta' inqas minn 30°C.
English: Dogs tolerated single oral doses up to 100 mg/kg without mortality.
Maltese: Il-klieb felħu dożi orali b'waħdiet sa 100 mg/kg mingħajr mortalità.
English: Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Maltese: 10 mg kuljum f'terapija flimkien ma' xi sustanza oħra (ara sezzjoni 5.1).
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).. A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Maltese: B'mod mhux komuni (≥ 0.1% u < 1%) ġiet irrapportata assoċjazzjoni temporali bejn il-kura b'olanzapine u t- tromboemboliżmu fil-vini.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittivita' eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fit taqsima 6.1.
English: Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Maltese: Mutaġeniċità Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f'firxa sħiħa ta' testijiet standard, li nkludew testijiet ta' mutazzjoni tal-mikrobi kif ukoll testijiet fuq il-mammiferi kemm in vitro kif ukoll in vivo.
English: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high
Maltese: 15 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.
English: SPECIAL STORAGE CONDITIONS Store below 30C
Maltese: Aħżen f'temperatura ta' inqas minn 30°C
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high
Maltese: 5 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.69 mmol/l) li żdiedu għal għoljin (≥