FrancophonIA/ELRC3.0 huggingface dataset:
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Apotex dose.
Maltese: • Carbamazepine (anti-epilettiku u stabilizzatur tal-burdata), fluvoxamine (anti-dipressant), jew ciprofloxacin (antibijotiku), għax jista' jkun hemm bżonn li tbiddel id-doża tiegħek ta' Olanzapine
English: NL-2333 CN Leiden Netherlands
Maltese: NL-2333 CN Leiden L-Olanda
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to
Maltese: Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa
English: 9 Adverse event identified from clinical trials in the Olanzapine Integrated Database.
Maltese: 9 Avveniment avvers identifikat minn provi kliniċi fid-Database Integrat ta' Olanzapine.
English: High uric acid 10
Maltese: Uric Acid għoli10
English: Manufacturer Apotex Nederland B.V. Archimedesweg 2
Maltese: Il-Manifattur Apotex Nederland B.V. Archimedesweg 2
English: Eosinophil ia and Systemic Symptoms (DRESS)
Maltese: Reazzjoni talmediċina b'eożinofilja u Sintomi Sistemiċi (DRESS)
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Maltese: Komuni ħafna: Sedazzjoni (inklużi: ipersomnja, letarġija, sedazzjoni (użu ta' kalmanti), sonnolenza).
English: Dystonia (including oculogyration) 11
Maltese: Distonja (tinkludi okuloġirazzjoni)11
English: Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Maltese: Tromboemboliżmu (inkluż l-emboliżmu pulmonari u t-trombożi tal-vini fil-fond) (ara sezzjoni 4.4)
English: Olanzapine Apotex contains the active substance olanzapine.
Maltese: Olanzapine Apotex fih is-sustanza attiva olanzapine.
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindromu ta' rtirar millmediċina neonatali (ara sezzjoni 4.6)
English: With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Maltese: B'espożizzjoni fit-tul (mill-inqas 24 ġimgħa), 89.4% żiedu ≥ 7%, 55.3% żiedu ≥ 15% u 29.1% żiedu ≥ 25% mil-linja bażi tal-piż tal-ġisem.
English: However, olanzapine (520 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Maltese: Madankollu, olanzapine (520 mg) wera profil ta' sigurtà kumparabbli f'pazjenti nisa (n=467) u f'pazjenti rġiel (n=869).
English: • Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Maltese: • Episodji ta' manija moderati għal severi, kondizzjoni b'sintomi ta' eċċitament jew ewforija.
English: and 98 tablets.
Maltese: 56 u 98 pillola.
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 kumparabbli f'pazjenti nisa (n=467) u f'pazjenti rġiel (n=869).
English: There were more smokers among subjects with cirrhosis (4/6; 67 %) than among subjects with no hepatic dysfunction (0/3; 0 %).
Maltese: Kien hemm aktar nies li jpejpu fost is-suġġetti b'ċirrożi (4/6; 67 %) milli fost issuġġetti li ma kellhom ebda disfunzjoni epatika (0/3; 0 %).
English: Olanzapine is indicated for the treatment of moderate to severe manic episode.
Maltese: Olanzapine huwa indikat għall-kura ta' episodju ta' manija moderat jew serju.
English: Musculoskeletal and connective tissue disorders Arthralgia9
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Artralġja9
English: Potential interactions affecting olanzapine
Maltese: Potenzjal ta' interazzjonijiet ma' olanzapine
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: Olanzapine ma kienx statistikament inferjuri għal lithium fuq l-għan ewlieni ta' rikorrenza bipolari (olanzapine 30.0%, lithium 38.3%; p = 0.055).
English: High creatine phosphokinase11
Maltese: Creatine phosphokinase għoli11
English: In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Maltese: F'44 pazjenti skiżofreniċi li għandhom > 65 sena, id-dosaġġ minn 5 sa 20 mg/kuljum ma kienx assoċjat ma' xi profil distint ta' avvenimenti avversi.
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' lassoċjati sintomi dipressivi (medja ta' punteġg ta' 16.6 meħud fil-bidu tal-kura skont l-iskala li tivvaluta d-dipressjoni ta' Montgomery-Asberg), analiżi prospettiva sekondarja tat-tibdil fil-punteġġ ta' l-atteġġament bejn il-bidu u fl-aħħar tal-kura wriet titjib statistikament sinifikanti (p= 0.001) favur olanzapine (-6.0) kontra haloperidol (-3.1).
English: The predominant pharmacologic activity is from the parent, olanzapine.
Maltese: L-attività farmakoloġika predominanti ġejja minn olanzapine nnifsu.
English: 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hrs) 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' 18.2 l/siegħa).
English: Metabolism and nutrition disorders Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna: Żieda fil-piż13, livelli elevati ta' trigliċeridi14, żieda fl-aptit.
English: Neuroleptic malignant syndrome (see section 4.4)12
Maltese: Newrolettiku Malinn (ara sezzjoni 4.4)12
English: Tel: (34) 91.486.15.65
Maltese: Apotex ESPAÑA S.L. Tel: (34) 91.486.15.65
English: In non-smoking versus smoking subjects (males and females), the mean elimination half-life was prolonged (38.6 versus 30.4 hrs) 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 kienet itwal (38.6 kontra 30.4 siegħa) u l-clearance inqas (18.6 kontra 27.7 l/siegħa).
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 available data).
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 magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Metabolism and nutrition disorders Weight gain1
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Żieda filpiż1
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 irrappurtati 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 sezzjoni 4.4), glukosurja, żieda fl-aptit, sturdament, akatiżja, parkinsoniżmu, lewkopenija, newtropenija (ara sezzjoni 4.4), diskineżja, pressjoni baxxa mal-waqfien, effetti antikolinerġiċi, żieda fil-livelli tal-aminotransferases tal-fwied u li huma mumentanji (ara sezzjoni 4.4), raxx, astenja, għeja, deni, artralġja, żieda fil-livell tal-alkaline phophatase, livell għoli ta' gamma glutamyltransferase, livell għoli ta' aċtu uriku, livell għoli ta' creatine phosphokinase u edima.
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Maltese: Olanzapine huwa sustanza antipsikotika, kontra l-manija u stabilizzatur tal-burdati li juri profil farmakoloġiku ta' firxa wiesa' ta' sistemi ta' riċetturi.
English: Archimedesweg 2, 2333 CN, Leiden, The Netherlands
Maltese: Archimedesweg 2 2333 CN Leiden L-Olanda
English: Olanzapine is bound predominantly to albumin and α1-acid-glycoprotein.
Maltese: Olanzapine huwa fil-biċċa 'l kbira marbut mal-albumina u B1B-acidglycoprotein.
English: Preventing recurrence in bipolar disorder:
Maltese: Il-prevenzjoni tar-rikorrenza fid-diżordni bipolari:
English: 12 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: 12 Avveniment avvers identifikat minn rappurtaġġ spontanju wara li l-prodott tqiegħed fis-suq bil frekwenza stmata fl-ogħla limitu tan-95% intervall ta' kunfidenza bl-użu tad-Database Integrat ta' Olanzapine.
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Maltese: In-newtropenja kienet irrappurtata spiss meta olanzapine u valproate intużaw flimkien (ara sezzjoni 4.8).
English: NV Apotex SA Tél: (32) 475.35.40 Hrvatska
Maltese: NV Apotex SA Tél: (32) 475.
English: Eosinophili a and
Maltese: 0 l/siegħa).
English: Elevated cholesterol levels Elevated glucose levels4
Maltese: Livelli għolja ta' glucose4
English: Mannitol (E421)
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Mannitol (E421)
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 irrakkomandat l-użu konkomitanti ta' olanzapine ma' prodotti mediċinali kontra l-Parkinson f'pazjenti bil-marda ta' Parkinson u d-demenzja (ara sezzjoni 4.4).
English: Olanzapine Apotex 2.5 mg film-coated tablets Olanzapine Apotex 5 mg film-coated tablets Olanzapine Apotex 7.5 mg film-coated tablets Olanzapine Apotex 10 mg film-coated tablets
Maltese: Olanzapine Apotex 2.5 mg pilloli miksija b'rita Olanzapine Apotex 5 mg pilloli miksija b'rita Olanzapine Apotex 7.5 mg pilloli miksija b'rita Olanzapine Apotex 10 mg pilloli miksija b'rita Olanzapine
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 skont Fridericia [QTcF] ≥ 500 millisekondi [msek] fi 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: 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 jistgħu jkunu livelli għolja ta' valproate fil-plażma.
English: Tel: (48) 22.311.20.00
Maltese: Apotex Polska Sp. z o.o. Tel: (48) 22.311.20.00
English: Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Maltese: Olanzapine jista' jantagonizza direttament jew indirettament l-effetti ta' l-agonisti ta' dopamine .
English: BN
Maltese: BŻONN
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 rrappurtati avvenimenti avversi ċerebro-vaskulari (CVAE, eż. puplesija, attakki iskemiċi temporanji) inklużi l-imwiet.
English: Olanzapine Apotex contains lactose
Maltese: Olanzapine Apotex fih lactose:
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien NV Apotex SA
English: Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Maltese: Effetti sekondarji rari ħafna jinkludu reazzjonijiet allerġiċi serji bħal Reazzzjoni tal-Mediċina b'Eożinofilja u Sintomi Sistemiċi (DRESS).
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: Sintomi oħra morbużi ta' doża eċċessiva li huma medicament sinifikanti jinkludu d-delirju, ilkonvulżjoni, koma, possibbilment Sindromu Newrolettiku Malinn, depressjoni respiratorja, aspirazzjoni fil-passaġġ respiratorju, pressjoni tad-demm għolja jew baxxa, taħbit tal-qalb irregolari (< 2% tal-każijiet ta' doża eċċessiva) u arrest kardjopulmonari.
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: L-enżimi ċitokromju P450-CYP1A2 u P450-CYP2D6 jikkontribwixxu għall-formazzjoni ta' prodotti metaboliċi tat-tip N-desmethyl u 2-hydroxymethyl.
English: High Gamma Glutamyltransferase
Maltese: Glutamyltransferase għoli10
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: Fluoxetine (inibitur CYP2D6), dożi b'waħdiet ta' antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il-komportament farmakokinetiku ta' olanzapine.
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 fissezzjoni 6.1.
English: As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Maltese: Minħabba li in vitro juri antagoniżmu għal dopamine, olanzapine jista' jantagonizza l-effetti diretti u indiretti ta' l-agonisti ta' dopamine.
English: Hypothermia
Maltese: Fertilità
English: The daily dose of Olanzapine Apotex is between 5 mg and 20 mg.
Maltese: Id-doża ta' kuljum ta' Olanzapine Apotex hija bejn 5 mg u 20 mg.
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 fl-imġiba, kien hemm żieda ta' darbtejn aktar flinċidenza ta' mwiet fil-pazjenti kkurati b'olanzapine, mqabbla ma' pazjenti kkurati bil-plaċebo (3.5% kontra 1.5%, rispettivament).
English: Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Maltese: Sinjali ta' tossiċità orali fir-rodenti kienu simili għas-sustanzi newrolettiċi qawwija:attività baxxa, koma, rogħda, konvulżjonijiet kloniċi, salivazzjoni, u tnaqqis fiż-żieda tal-piż.
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 prominenti kienu d-depressjoni CNS, effetti antikolinerġiċi, u taqlib periferali ematoloġiċi.
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 filbniedem) u l-parametri tar-riproduzzjoni kienu influwenzati fil-firien mogħtija 3 mg/kg (9 darbiet iddoża massima fil-bniedem).
English: Common: Elevated cholesterol levels
Maltese: Komuni: Livelli għolja ta' kolesterol15
English: Animal behavioural studies with olanzapine indicated 5 HT, 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: Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Maltese: 16 F'47.4% tal-pazjenti adolexxenti ġew irrappurtati livelli għoljin ta' prolactin fil-plażma.
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 inizjali għandha tkun 5 mg u tiżdied biss b'kawtela.
English: Investigations Elevated plasma prolactin levels
Maltese: Investigazzjonijiet Livelli elevati ta' prolactin fil-plażma 8
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
Maltese: Tużax epinephrine, dopamine, jew sustanzi oħra simpatomimetiċi b'attività beta-agonista għax listimulazzjoni beta tista' taggrava l-pressjoni baxxa.
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 persuna 1 minn kull 100 persuna) jinkludu sensittività eċċessiva (eż. nefħa fil-ħalq u l-gerżuma, ħakk, raxx);dijabete jew dijabete li tmur għallagħar, 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); sindromu ta' saqajn irrikwieti, problemi fil-mod kif titkellem; temtim; il-qalb tħabbat bil-mod; sensittività għad-dawl tax-xemx; tinfaraġ; nefħa fl-addome; telf tal-memorja jew tibda tinsa; inkontinenza urinarja; nuqqas ta' kapaċità li tgħaddi l-urina; jaqa' x-xagħar; nuqqas ta' jew tnaqqis fil-mestrwazzjoni u tibdil fis-sider fl-irġiel u fin-nisa bħal produzzjoni mhux normali ta' ħalib mis-sider jew tkabbir mhux normali.
English: Excipient with known effect: Each film-coated tablet contains 126.34 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 126.34 mg ta' lactose.
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 kellhom rispons b'olanzapine fl-episodju ta' manija tagħhom, olanzapine huwa indikat għall-prevenzjoni ta' rikorrenza f'pazjenti b'diżordni bipolari (ara sezzjoni 5.1).
English: 2333 CN Leiden The Netherlands
Maltese: 2333 CN Leiden L-Olanda
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 ta' madwar 93% fuq il-firxa tal-konċentrazzjoni ta' madwar 7 sa xi 1000 ng/ml.
English: Urinary incontinence, urinary retention
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Inkontinenza urinarja, żamma tal-urina
English: Olanzapine Apotex with alcohol
Maltese: Olanzapine Apotex mal-alkoħol
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' 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: Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Maltese: Il-potenzjal ta' olanzapine biex jaffetwa prodotti mediċinali oħra Olanzapine jista' jantagonizza direttament jew indirettament l-effetti ta' l-agonisti ta' dopamine.
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 (mill-inqas 48 ġimgħa). il-pazjenti li żiedu ≥ 7%, ≥ 15% u ≥ 25% mil-linja bażi tal-piż tal-ġisem kienu komuni ħafna (64.4%, 31.7% u 12.3% rispettivament).
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-burdati (lithium jew valproate), l-użu fit-tul ta' olanzapine flimkien ma' lithium jew valproate ma kienx statistikament sinifikanti superjuri għal lithium jew għal valproate waħdu biex jittardja r-rikorrenza bipolari, kif definit skont il-kriterji (dijanjostiċi) tas-sindromu.
English: 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: Hepatitis (including hepatocellular, cholestatic or mixed liver injury) 11
Maltese: Epatite (inkluż mard tal-fwied tat-tip epatoċellulari, kolestatiku jew tattnejn flimkien)11