FrancophonIA/ELRC3.0 huggingface dataset:
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 CYP2C19).
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 (CYP3A4 u 2C19).
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 ddepressjoni CNS, effetti antikolinerġiċi, u diżordnijiet periferali ematoloġiċi.
English: 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).
Maltese: Mhux rakkomandat l-użu konkomitanti ta' olanzapine ma' prodotti mediċinali kontra l-Parkinson f'pazjenti bil-marda ta' Parkinson u d-demenzja (ara taqsima 4.4).
English: The plasma protein binding of Olanzapine was about 93 % over the concentration range of about 7 to about 1000 ng/ml.
Maltese: Ir-rabta mal-proteina fil-plażma ta'olanzapine kienet madwar 93% fuq il-firxa tal-konċentrazzjoni ta' madwar 7 sa xi 1000 ng/ml.
English: SmokingIn 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' leliminazzjoni kien imtawwal (38.6 kontra 30.4 siegħa) u l-clearance tnaqqset (18.6 kontra 27.7 l/hr).
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] ≥≥ 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: 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 meta ittieħdet doża eċċessiva (> 10% inċidenza) jinkludu takikardija, aġitazzjoni/aggressività, diżartrija, sintomi ekstrapiramidali varji, u telf tas-sensi li tvarja minn sedazzjoni sa koma.
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Maltese: Disturbi fil-fwied u fil-marrara Żieda ta' aminotransferases talfwied (ALT, AST) bla sintomi u li tgħaddi malajr, speċjalmet filbidu tal-kura (ara taqsima 4.4)
English: Animal behavioural 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: 8 In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin value.
Maltese: 8 F'studji kliniċi li damu sa 12-il ġimgħa, il-konċentrazzjonijiet fil-plażma ta' prolactin qabżu l-ogħla limitu tal-marġni normali f'madwar 30 % tal-pazjenti kkurati b'olanzapine u li bħala linja bażi kellhom valuri normali ta' prolactin.
English: Aluminium/aluminium blisters in cartons of 28, 56, 70, 98 tablets per carton.
Maltese: Folji ta' aluminju/aluminju f'kartun ta' 28, 56, 70, 98 pillola għal kull kartuna.
English: In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes.
Maltese: Fl-assenza ta' tagħrif dettaljat dwar passat priezistenti 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: 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).
Maltese: Fl-istudji ta' terminu qasir, ġie rrapportat ammont akbar ta' żieda fil-piż u tibdil fix-xaħmijiet u prolactin f'pazjenti adolexxenti milli fl-istudji ta' pazjenti adulti (ara taqsimiet 4.4, 4.8, 5.1 u 5.2).
English: Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Maltese: Studji elettrofiżjoloġiċi wrew illi olanzapine b'mod selettiv naqqas l-istumulazzjoni tan-newroni dopaminerġiċi mesolimbiċi (A10), waqt li kellu ftit effett fuq is-sekwenza tar-reazzjoni strijatali (A9) involuta fil-funzjoni motorjali.
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 fistaqsima 6.1.
English: What Olanzapine Glenmark looks like and contents of the pack Olanzapine Glenmark 2.5mg is supplied as: yellow coloured circular flat bevelled edge tablets with ‘A' debossed on one side.
Maltese: Id-dehra ta' Olanzapine Glenmark u l-kontenuti tal-pakkett Olanzapine Glenmark 2.5 mg tiġi bħala: pilloli tondi, ċatti, kulur isfar bil-ġnub imċanfrin b'‘A' imnaqqax fuq naħa waħda.
English: Following short term treatment (median duration 47 days), weight gain ≥ 7 % of baseline body weight was very common (22.2%), ≥ 15% was common (4.2%) and ≥25% was uncommon (0.8%).
Maltese: Wara kura għal żmien qasir (medjan ta' tul ta' żmien ta' 47 ġurnata), żieda fil-piż ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem kienet komuni ħafna (22.2 %), ≥ 15% kienet komuni (4.2 %) u ≥ 25 % ma kinitx komuni (0.8 %).
English: Detailed information on this medicine is available on the European Medicines Agency 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: There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3 % versus 0.4 %, respectively).
Maltese: f'pazjenti ttattati b'olanzapine, meta mqabblin ma' pazjenti ttrattati bil-plaċebo (1.3% kontra 0.4%, rispettivament).
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Maltese: Olanzapine naqqas ir-rispons ta' ħrib kundizzjonat, test indikattiv ta' l-attività antipsikotika, f'dożi anqas minn dawk li jwasslu għall-katalepsi, konsegwenza indikattiva ta' effett motorju mhux mixtieq.
English: Olanzapine Glenmark 7.5 mg: yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Maltese: Olanzapine Glenmark 7.5 mg: pilloli tondi, ċatti, kulur isfar bil-ġnub imċanfrin bi ‘C' imnaqqax fuq naħa waħda.
English: Breast feeding
Maltese: Popolazzjoni pedjatrika
English: How to store Olanzapine Glenmark
Maltese: Tieħux Olanzapine Glenmark
English: MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH Industriestr.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq Glenmark Arzneimittel GmbH Industriestr.
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindromu ta' rtirar mill-mediċina neonatali (ara taqsima 4.6)
English: Olanzapine Glenmark 10 mg tablets
Maltese: Olanzapine Glenmark 10 mg pilloli
English: 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.
Maltese: Tibdil fit-trigliċeridi waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 1.69 mmol/l- < 2.26 mmol/l) għal għoljin (≥ 2.26 mmol/l) kienu komuni ħafna.
English: In the same clinical trials, cerebrovascular adverse events (CVAE e.g., stroke, transient ischemic attack), including fatalities, were reported.
Maltese: Fl-istess studji kliniċi, kienu rrapportati avvenimenti avversi ċerebro-vaskulari (CVAE eż puplesija, attakki iskemiċi momentanji) inklużi l-imwiet.
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: Blood and the lymphatic system disorders Eosinophilia
Maltese: Disturbi tad-demm u tas-sistema limfatika Eosinofilja
English: 30 months
Maltese: 30 xhur
English: Olanzapine Glenmark 7.5 mg tablets
Maltese: Olanzapine Glenmark 7.5 mg pilloli
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 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: Olanzapine Glenmark 15 mg tablets
Maltese: Olanzapine Glenmark 15 mg pilloli
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Maltese: Tibdil fil-livelli tal-kolesterol totali waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 5.17 - < 6.2 mmol/l) għal għoljin (≥ 6.2 mmol/l) kienu komuni ħafna.
English: 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: mmol/l) were observed commonly.
Maltese: 7 mmol/l).
English: 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 1.5 %, respectively).
Maltese: Fi studji kliniċi kkontrollati bil-plaċebo (li damu minn 6 sa 12-il ġimgħa ), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożi relatata mad-demenzja u/jew disturbi fil-komportament, kien hemm żieda ta' darbtejn akbar fl-inċidenza ta' mwiet fil-pazjenti ttrattati b'olanzapine, mqabbla ma' pazjenti ttrattati bil-plaċebo (3.5% kontra 1.5%, rispettivament).
English: Other medicines and Olanzapine Glenmark
Maltese: Mediċini oħra u Olanzapine Glenmark
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH
Maltese: FIS-SUQ Glenmark Arzneimittel GmbH
English: The daily dose of Olanzapine Glenmark is between 5 mg and 20 mg.
Maltese: Id-doża ta' kuljum ta' Olanzapine Glenmark hija bejn 5 mg u 20 mg.
English: 10 As assessed by measured values from clinical trials in the Olanzapine Integrated Database.
Maltese: Kif evalwat minn valuri meħuda minn provi kliniċi fid-Database Integrat ta' Olanzapine.
English: Very common: Weight gain 13, elevated triglyceride levels 14, increased appetite.
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna: Żieda fil-piż13, livelli elevati ta' trigliċeridi14, żieda fl-aptit.
English: Children and adolescents Olanzapine Glenmark is not for patients who are under 18 years.
Maltese: Tfal u adolexxenti Olanzapine Glenmark mhux għal pazjenti li għandhom anqas minn 18-il sena.
English: EU/1/09/587/004 EU/1/09/587/005 EU/1/09/587/006 EU/1/09/587/021
Maltese: EU/1/09/587/005 EU/1/09/587/006 EU/1/09/587/021
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: Newtropenja, 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: Olanzapine Glenmark 2.5 mg tablets
Maltese: Olanzapine Glenmark 2.5 mg pilloli
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5 HT2 than dopamine D2 receptors and greater 5HT2 than D2 activity in vivo, models.
Maltese: dopamine D2 u attività in vivo akbar għal 5-HT2 milli għal D2.
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% talpazjenti.
English: EU/1/09/587/013 EU/1/09/587/014 EU/1/09/587/015 EU/1/09/587/024
Maltese: EU/1/09/587/016 EU/1/09/587/017 EU/1/09/587/018 EU/1/09/587/019 EU/1/09/587/025
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 2.5 mg olanzapine.
English: Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Maltese: Wara espożizzjoni fit-tul (għallinqas 48 ġimgħa). ilpazjenti li żiedu ≥ 7 %, ≥ 15 % u ≥ 25 % mil-linja bażi tal-piż tal-ġisem tagħhom kienu komuni ħafna (64.4 %, 31.7 % u 12.3 % rispettivament).
English: Olanzapine Glenmark 5 mg: yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Maltese: Olanzapine Glenmark 5 mg: pilloli tondi, ċatti, kulur isfar bil-ġnub imċanfrin bi ‘B' imnaqqax fuq naħa waħda.
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 fillivelli ta' prolactin (ara taqsimiet 4.8 u 5.1).
English: 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).
Maltese: Waqt trattament b'olanzapine flimkien ma' lithium jew divalproex, żieda ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem seħħet f' 17.4% tal-pazjenti waqt it-trattament akut (sa 6 ġimgħat).
English: • Stuttering
Maltese: • Dijabete
English: Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Maltese: Olanzapine hija metabolizzata fil-fwied minn metodi konjugattivi u ossidattivi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg olanzapine.
English: 4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 5.56 mmol/l) li żdiedu għal għoljin (≥
English: Fertility Effects on fertility are unknown (see section 5.3 for preclinical information).
Maltese: L-effetti fuq il-fertilità mhumiex magħrufa (ara taqsima 5.3 għal informazzjoni ta' qabel l-użu kliniku).
English: Olanzapine Glenmark 10 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Maltese: Olanzapine Glenmark 10 mg: pilloli tondi, ċatti, kulur isfar bil-ġnub imċanfrin b'‘OL' imnaqqxa fuq naħa waħda u b'‘D' imnaqqax fuq in-naħa l-oħra.
English: Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Maltese: Pazjenti kkurati b'mediċini antipsikotiċi, inkluż ZYPREXA, għandhom ikunu taħt osservazzjoni għal sinjali u sintomi ta' ipergliċemija (bħal polidipsja, polijurja, polifaġja u debbulizza) u pazjenti bid-dijabete mellitus jew li għandhom fatturi ta' riskju għad-dijabete mellitus għandhom jiġu segwiti b'mod regolari f'każ li l-kontroll tal-glukosju jmur għall-agħar.
English: Oedema Pyrexia10
Maltese: Nefħa fl-addome9
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 15 mg olanzapine.
English: 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).
Maltese: F'pazjenti li l-episodju ta' manija tagħhom irreaġixxa għat-trattament ta' olanzapine, olanzapine hija indikata għall-prevenzjoni ta' rikorrenza f'pazjenti b'diżordni bipolari (ara taqsima 5.1).
English: Aluminium/aluminium blisters in cartons of 28, 35, 56, 70 and 98 tablets per carton.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folji ta' aluminju/aluminju f'kartun ta' 28, 35, 56, 70, 98 pillola għal kull kartuna.
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Maltese: Psikożi relatata mad-demenzja u/jew disturbi fil-komportament Olanzapine mhux irrakkomandat għall-użu f'pazjenti b'psikożi relatata mad-demenzja u/jew disturbi fil-komportament, dovut għal żieda fil-mortalità u r-riskju ta' inċident ċerebro-vaskulari.
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2
Maltese: 3 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 5.17 mmol/l) li żdiedu għal għoljin (≥
English: 6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Maltese: Fi studji kliniċi, l-inċidenza tal-marda ta' Parkinson u distonja f'pazjenti kkurati b' olanzapine kienet numerikament ogħla, imma statistikament mhux differenti b'mod sinifikattiv mill-plaċebo.
English: Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Maltese: Sinjali kliniċi inkludew sedazzjoni, atassja, rogħda, żjieda fir-rata tal-qalb, diffikultà fir-respirazzjoni, tidjiq tal-pupilla ta' l-għajn, u l-anoreksja.
English: - High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Glenmark.
Maltese: • Livell għoli ta' zokkor fid-demm u livelli għolja ta' xaħmijiet (trigliċeridi u kolesterol) instabu f'pazjenti li qed jieħdu Olanzapine Glenmark.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 10 mg olanzapine.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 7.5 mg tablets Olanzapine
Maltese: Olanzapine Glenmark 7.5 mg pilloli Olanzapine
English: • 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: 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 section 4.4).
Maltese: Fi studji kliniċi f'pazjenti anzjani bid-demenzja, trattament b'olanzapine kien assoċjat ma' inċidenza ogħla ta' mwiet u reazzjonijiet avversi ċerebro-vaskulari meta mqabbla mal-plaċebo (ara taqsima 4.4).
English: Olanzapine Glenmark 15 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Maltese: Olanzapine Glenmark 15 mg: pilloli tondi, ċatti, kulur isfar bil-ġnub imċanfrin b'‘OL' imnaqqxa fuq naħa waħda u b'‘E' imnaqqax fuq in-naħa l-oħra.
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'
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.69 mmol/l) li żdiedu għal għoljin (≥
English: Neutropenia
Maltese: Fertilità
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 5 mg olanzapine.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 20 mg tablets Olanzapine
Maltese: Olanzapine Glenmark 20 mg pilloli Olanzapine
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (≥ 1.467
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.016 mmol/l) li żdiedu għal għoljin
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 fittermini tal-proporzjon ta' pazjenti f'remissjoni sintomatika minn manija u depressjoni f' 6 u 12-il ġimgħa.
English: Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/l) to high (≥ 7 mmol/l) were very common.
Maltese: Tibdil fil-livelli taz-zokkor waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 5.56 - < 7 mmol/l) għal għoljin (≥ 7m mol/l) kienu komuni ħafna.
English: Adults Olanzapine is indicated for the treatment of schizophrenia.
Maltese: Olanzapine hija indikata għat-trattament tal-iskiżofrenja.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 2.5 mg tablets Olanzapine
Maltese: Olanzapine Glenmark 2.5 mg pilloli Olanzapine
English: Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Maltese: Il-prodott metaboliku li l-aktar jiċċirkola huwa 10-N- glukoronide, li ma jaqsamx il-barriera bejn id-demm u l-moħħ. Lenżimi ċitokromju P450-CYP1A2 u P450-CYP2D6 jikkontrbwixxu għall-formazzjoni ta' prodotti metaboliċi tat-tip N-desmethyl u 2-hydroxymethyl.
English: phosphatase10
Maltese: Tromboċitopenija11
English: Crospovidone
Maltese: FARMAĊEWTIKU