FrancophonIA/ELRC3.0 huggingface dataset:
English: - the CVMP considered that stability of the mixed product up to 1 hour after mixing as claimed on the Summary of Product Characteristics was supported by the data provided, - the CVMP considered that the efficacy of the mixed vaccine regarding the PRRS component was sufficiently supported by the data provided, the CVMP has recommended the granting of the variation of the Marketing Authorisations for Porcilis PRRS and associated names (see Annex I).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fissuq iġġustifika permezz ta' referenza għad-dejta disponibbli li l-klejms ta' effiċjenza attwali għal Porcilis PRRS għadhom sostnuti meta ż-żewġ prodotti jitħalltu.
English: After mixing with Porcilis M Hyo: 1 hour at room temperature
Maltese: Wara li jitħallat ma' Porcilis M Hyo: 1 sigħa f' temperature tal-kamra.
English: The marketing authorisation holder considers that the reduction of clinical signs is the direct effect of reduction of viraemia.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jikkonsidra li t-tnaqqis ta' sinjali kliniċi huwa effett dirett tat-tnaqqis tal-viraemia.
English: Deseril Tablets 1mg 1mg
Maltese: Deseril Pilloli 1mg 1mg
English: Member State (in EEA)
Maltese: Stat Membru (fiż-ŻEE)
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, Mnejn għandu jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: 2 Bath Road, Chippenham
Maltese: Alliance Pharmaceuticals Ltd Avonbridge House 2 Bath Road, Chippenham Wiltshire, SN15 2BB United Kingdom
English: Marketing Authorisation Holder Invented name
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq
English: Wiltshire, SN15 2BB
Maltese: Il-Pajjiżi l-Baxxi
English: (See sections 4.5 and 5.2.)
Maltese: (Ara sezzjonijiet 4.5 u 5.2.)
English: Date of first authorisation: 27 September 2007 Date of latest renewal: 26 July 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 27 ta' Settembru 2007 Data tal-aħħar tiġdid: 26 ta' Lulju 2012
English: Równoległa 5, 02-235 Warszawa, Poland TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Maltese: Równoległa 5, 02-235 Warszawa, Il-Polonja TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Il-Ġermanja
English: Induction of CYP1A2
Maltese: Induzzjoni ta' CYP1A2
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Maltese: Madankollu, olanzapine (5-20 mg) wera profil ta' sigurtà komparabbli filpazjenti nisa (n=467) u fil-pazjenti rġiel (n=869).
English: Olanzapine had no teratogenic effects.
Maltese: Olanzapine ma kellux effetti teratoġeniċi.
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Maltese: Olanzapine ma jinibixxix l-isoenzimi CYP450 ewlenin in vitro (per eżempju 1A2, 2D6, 2C9, 2C19, 3A4).
English: The mean increase in olanzapine AUC was 52% and 108% respectively.
Maltese: Iż-żieda medja f'olanzapine AUC kienet ta' 52 % u 108 % rispettivament.
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Maltese: Olanzapine jintrabat prinċipalment mal-albumina u 1-acidglycoprotein.
English: Aspartame is a source of phenylalanine.
Maltese: Aspartame hu sors ta' phenylalanine.
English: - The other ingredients are mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate.
Maltese: Is-sustanzi l-oħra huma mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate.
English: See section 2 "Zalasta contains aspartame".
Maltese: Ara sezzjoni 2 "Zalasta fih aspartame".
English: , elevated triglyceride levels
Maltese: , livelli elevati ta' trigliċeridi
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; α1 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; -1 adrenerġiċi; riċetturi histamine H1.
English: Contains aspartame.
Maltese: Fih aspartame.
English: tablet
Maltese: pillola
English: Musculoskeletal and connective tissue disorders Arthralgia
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Artralġja
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Maltese: Komuni ħafna (>1/10), komuni (>1/100 sa < 1/10), mhux komuni (>1/1,000 sa <1/100), rari (>1/10,000 sa < 1/1,000), rari ħafna (<1/10,000), mhux magħrufa (ma jistgħux jiġu stmati mill-informazzjoni li hemm disponibbli).
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10).
Maltese: Komuni ħafna (≥1/10), komuni (≥1/100 sa < 1/10).
English: Zalasta contains aspartame
Maltese: Zalasta fih aspartame
English: Zalasta 10 mg tablets Each tablet contains 161.8 mg lactose.
Maltese: Zalasta 10 mg pilloli Kull pillola fiha 161.8 mg lactose.
English: 14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
Maltese: 14-il pillola 28 pillola 35 pillola 56 pillola 70 pillola
English: 7 tablets 14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
Maltese: 7 pilloli 14-il pillola 28 pillola 35 pillola 56 pillola 70 pillola
English: The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Maltese: Iddożi letali medjani kienu bejn wieħed u ieħor 210 mg/kg (fil-ġrieden) u 175 mg/kg (fil-firien).
English: 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).
Maltese: 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).
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, lewkopenija, newtropenija (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 tal-aminotransferases tal-fwied li ma jurux sintomi u li huma momentanji (ara sezzjoni 4.4), raxx, astenja, għeja, deni, artralġja, żieda fil-livell talalkaline phophatase, livell għoli ta' gamma glutamyltransferase, livell għoli ta' aċtu uriku, livell għoli ta' creatine phosphokinase u edima.
English: - The other ingredients are lactose monohydrate, powdered cellulose, pregelatinised maize starch, maize starch, colloidal anhydrous silica, magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, powdered cellulose, pregelatinised starch (vegetable origin), maize starch, colloidal anhydrous silica, magnesium stearate.
English: Zalasta contains the active substance olanzapine.
Maltese: Zalasta fih is-sustanza attiva olanzapine.
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels
Maltese: Tnaqqis fil-bilirubin totali, żieda ta' GGT, livelli elevati ta' prolactin fil-plażma
English: Olanzapine is indicated for the treatment of moderate to severe manic episode.
Maltese: Olanzapine hu indikat għat-trattament ta' episodji ta' manija minn moderati sa severi.
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: L-estrous cycles kienu affettwati f'dożi ta' 1.1 g/kg (3 darbiet ikbar mid-doża massima umana) u l-parametri riproduttivi kienu influwenzati fil-firien li ngħataw 3 g/kg (9 darbiet id-doża massima umana).
English: Common: Elevated cholesterol levels
Maltese: Komuni: Livelli għolja ta' kolesterol
English: Increased alkaline phosphatase High creatine phosphokinase High Gamma Glutamyltransferase High uric acid
Maltese: Żieda f'alkaline phosphatase Creatine phosphokinase għoli Gamma
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 hi mistennija l-ebda interazzjoni partikolari kif verifikat fi studji in vivo fejn ma nstabet l-ebda minn dawn is-sustanzi attivi: antidepressanti triċikliċi (li prinċiparjament jirrappreżentaw s-sekwenza CYP2D6), warfarin (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
English: Parkinson's disease
Maltese: Parkinsoniżmu Diskineżja
English: Adverse event identified from clinical trials in the Olanzapine Integrated Database.
Maltese: Avveniment avvers identifikat minn provi kliniċi fid-Database Integrat ta' Olanzapine.
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: Fi studju multinazzjonali double-blind komparattiv ta' l-iskiżofrenija, mard skiżoaffettiv u mard ieħor relatat li fih ħadu sehem 1,481 pazjent bi gradi varji ta' sintomi dipressivi assoċjati (medja bażi ta' 16.6 fuq l-iskala tad-dipressjoni Montgomery-Asberg), saret analiżi sekondarja prospettiva tat-tibdil fil-punteġġ talburdati mill-bażi sa l-aħħar u din uriet li kien hemm titjib statistikament sinjifikant (p=0.001) favur olanzapine (-6.0) meta mqabbel ma' haloperidol (-3.1).
English: Investigations Elevated plasma prolactin levels
Maltese: Livelli elevati ta' prolactin fil-plażma
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), - it may be necessary to change your Zalasta dose.
Maltese: Carbamazepine (anti-epilettiku u stabilizzatur tal-burdata)fluvoxamine (anti-dipressant), jew ciprofloxacin (antibijotiku), għax jista' jkun hemm bżonn li tinbidel id-doża tiegħek ta' Zalasta.
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5 HT2 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: Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine.
Maltese: Kull pillola fiha 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg jew 20 mg olanzapine
English: Zalasta 15 mg tablets Each tablet contains 242.7 mg lactose.
Maltese: Zalasta 15 mg pilloli Kull pillola fiha 242.7 mg lactose.
English: Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Maltese: F'47.4% tal-pazjenti adolexxenti ġew irrapportati livelli għoljin ta' prolactin fil-plażma.
English: Zalasta 20 mg tablets EU/1/07/415/027-031
Maltese: Zalasta 20 mg pilloli EU/1/07/415/027-031
English: Zalasta 20 mg tablets
Maltese: Zalasta 20 mg pilloli
English: Zalasta 7.5 mg tablets Each tablet contains 121.3 mg lactose.
Maltese: Zalasta 7.5 mg pilloli Kull pillola fiha 121.3 mg lactose.
English: The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Maltese: Ilmetabolit ewlieni fiċ-ċirkulazzjoni hu l-1 0-N-glucuronide, li ma jgħaddix mill-blood brain barrier.
English: 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.
Maltese: 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.
English: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Maltese: Il-potenzjal ta' olanzapine li jaffettwa prodotti mediċinali oħra Olanzapine jista' jantagonizza l-effetti ta' agonisti diretti u indiretti tad-dopamina.
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: Meta tqabblu anzjani (ta' 65 sena jew iktar) f'saħħithom ma' persuni mhux anzjani, il-half-life ta' leliminazzjoni terminali medja ttawlet (51.8 u 33.8 siegħa rispettivament) u r-rata ta' tneħħija tnaqqset (17.5 u 18.2 litru fis-siegħa rispettivament).
English: Acute (single-dose) toxicity
Maltese: Effett tossiku akut (minn doża waħda)
English: Eosinophilia and Systemic Symptoms (DRESS)
Maltese: Reazzjoni għallMediċina b'Esinofilja u Sintomi Sistemiċi (DRESS)
English: Zalasta 7.5 mg tablets
Maltese: Zalasta 7.5 mg pilloli
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Maltese: Olanzapine hu sustanza antipsikotika, antimanijaka u li tistabbilizza l-burdata li turi profil farmakoloġiku wiesa' f'diversi sistemi ta' riċetturi.
English: Zalasta 20 mg orodispersible tablets Each orodispersible tablet contains 2.00 mg aspartame.
Maltese: Zalasta 20 mg pilloli li jinħallu fil-ħalq Kull pillola fiha 2.00 mg aspartame.
English: Zalasta 15 mg tablets EU/1/07/415/022-026
Maltese: Zalasta 15 mg pilloli EU/1/07/415/022-026
English: Fluvoxamine, a specific CYP 1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Maltese: Intwera li fluvoxamine, inibitur speċifiku tas-CYP 1A2, jinibixxi b'mod sinjifikanti l-metaboliżmu ta' olanzapine.
English: Decreased bioavailability
Maltese: Tnaqqis fil-bijodisponibilità
English: Epistaxis
Maltese: Astenja
English: Zalasta 2.5 mg tablets EU/1/07/415/001-005
Maltese: Zalasta 2.5 mg pilloli EU/1/07/415/001-005
English: Abdominal distension 9 Pancreatitis
Maltese: .9 Doża eċċessiva
English: The predominant pharmacologic activity is from the parent olanzapine.
Maltese: L-attività farmakoloġika predominanti hi mill-olanzapine oriġinali.
English: Zalasta 5 mg tablets EU/1/07/415/006-010
Maltese: Zalasta 5 mg pilloli EU/1/07/415/006-010
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 l/hr).
Maltese: Meta tqabblu pazjenti bi problemi fil-kliewi (b'rata ta' tneħħija tal-kreatinina ta' inqas minn 10 ml/min) ma' persuni f'saħħithom, ma kienx hemm differenza sinjifikanti fil-half-life ta' l-eliminazzjoni terminali medja (37.7 siegħa u 32.4 siegħa rispettivament) jew fir-rata ta' tneħħija (21.2 u 25.
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: Olanzapine ma kellux effett tossiku fuq il-ġeni f'varjetà sħiħa ta' testijiet, li kienu jinkludu testijiet ta' mutazzjonijiet batteriċi u testijiet tal-mammiferi in vitro u in vivo.
English: Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Maltese: Olanzapine jiġi assorbit tajjeb wara li jingħata oralment, u jilħaq konċentrazzjonijiet massimi fil-plażma wara bejn 5 u 8 sigħat.
English: Zalasta 2.5 mg tablets
Maltese: Zalasta 2.5 mg pilloli
English: 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.
Maltese: Waqt it-trattament għall-iskiżofrenija, episodji ta' manija u l-prevenzjoni ta' disturbi bipolari, id-doża ta' kuljum tista' tiġi sussegwentement aġġustata skond l-istat kliniku individwali bejn 5 u 20 mg kuljum.
English: Zalasta 7.5 mg tablets EU/1/07/415/011-015
Maltese: Zalasta 7.5 mg pilloli EU/1/07/415/011-015
English: 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.
Maltese: Sintomi komuni ħafna fil-każ ta' doża eċċessiva (inċidenza ta' iktar minn 10%) jinkludu t-takikardija, aġitazzjoni/agressività, dysarthria, diversi sintomi estrapiramidali, u tnaqqis fil-livell ta' konoxxenza tal-pazjent li tvarja minn sedazzjoni għal koma.
English: Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Maltese: Għandu jkun hemm trattament sintomatiku u sorveljanza tal-funzjoni ta' l-organi vitali skond ilpreżentazzjoni klinika, inkluż it-trattament tal-pressjoni baxxa u tal-kollass ċirkulatorju u appoġġ talfunzjoni respiratorja.
English: Ventricular tachycardia/fibrillat ion, sudden death (see section 4.4)
Maltese: Takikardija/ fibrillazzjoni ventrikulari, mewt għall-għarrieda (ara sezzjoni 4.4)
English: The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non-smokers and 77% in male smokers.
Maltese: Iż-żieda medja f'olanzapine (Cmax) wara l-għoti ta' fluvoxamine kienet ta' 54 % fin-nisa li ma kinux ipejpu u 77 % f'irġiel li ma kinux ipejpu.
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: Meta tqabblu rġiel u nisa jpejpu ma' dawk li ma jpejpux, il-half-life ta' l-eliminazzjoni terminali medja kienet itwal (38.6 siegħa u 30.4 siegħa rispettivament) u r-rata ta' tneħħija tnaqqset (18.6 u 27.7 litru fis-siegħa rispettivament).
English: Zalasta 7.5 mg tablets Olanzapine
Maltese: Zalasta 7.5 mg pilloli Olanzapine
English: Nervous system disorders Somnolence
Maltese: Disturbi fis-sistema nervuża Sonnolenza Sturdament Akatizja
English: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebocontrolled clinical trials (see section 4.8).
Maltese: Ġew osservati alterazzjonijiet mhux mixtieqa fil-lipidi f'pazjenti ttrattati b'olanzapine fi provi kliniċi kkontrollati bi plaċebo (ara sezzjoni 4.8).
English: Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database.
Maltese: Avveniment avvers identifikat minn rappurtaġġ spontanju wara li l-prodott tqiegħed fis-suq bilfrekwenza stmata fl-ogħla limitu tan-95% intervall ta' kunfidenza bl-użu tad-Database Integrat ta' Olanzapine.
English: A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Maltese: Sar studju tal-bilanċ tal-massa li wera li madwar 57% ta' olanzapine radjutikkettat deher fl-awrina, prinċipalment bħala metaboliti.
English: The plasma protein binding of olanzapine was about 93 % over the concentration range of about 7 to about 1000 ng/ml.
Maltese: L-irbit ta' proteini fil-plażma ma' olanzapine kien madwar 93% fuq il-firxa ta' konċentrazzjonijiet ta' madwar 7 sa madwar 1000 ng/ml.
English: 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.
Maltese: 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.
English: Zalasta 2.5 mg tablets Zalasta 5 mg tablets Zalasta 7.5 mg tablets Zalasta 10 mg tablets Zalasta 15 mg tablets Zalasta 20 mg tablets Olanzapine
Maltese: Zalasta 2.5 mg pilloli Zalasta 5 mg pilloli Zalasta 7.5 mg pilloli Zalasta 10 mg pilloli Zalasta 15 mg pilloli Zalasta 20 mg pilloli Olanzapine
English: Zalasta 2.5 mg tablets Zalasta 5 mg tablets Zalasta 7.5 mg tablets Zalasta 10 mg tablets Zalasta 15 mg tablets Zalasta 20 mg tablets
Maltese: Zalasta 2.5 mg pilloli Zalasta 5 mg pilloli Zalasta 7.5 mg pilloli Zalasta 10 mg pilloli Zalasta 15 mg pilloli Zalasta 20 mg pilloli
English: 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.
Maltese: Konsegwenzi oħra medikament sinjifikanti ta' doża eċċessiva jinkludu d-delirju, konvulżjoni, koma, possibbilment sindromu newrolettiku malinn, dipessjoni respiratorja, aspirazzjoni, pressjoni għolja jew baxxa, ritmi irregolari tal-qalb (li jseħħu f'iktar minn 2% tal-każijiet ta' doża eċċessiva) u waqfien talfunzjoni tal-qalb u tal-pulmun.
English: Zalasta 2.5 mg tablets Each tablet contains 40.4 mg lactose.
Maltese: Zalasta 2.5 mg pilloli Kull pillola fiha 40.4 mg lactose.
English: Zalasta 15 mg tablets
Maltese: Zalasta 15 mg pilloli
English: There is no specific antidote for olanzapine.
Maltese: Ma hemm l-ebda antidotu speċifiku għal olanzapine.
English: The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
Maltese: Intwera li l-amministrazzjoni tal-faħam attivat tista' tnaqqas ilbijodisponibilità orali b'bejn 50 u 60%.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs. 0.4%, respectively).
Maltese: 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).
English: Zalasta 10 mg tablets
Maltese: Zalasta 10 mg pilloli