FrancophonIA/ELRC3.0 huggingface dataset:
English: Tear.
Maltese: Ċarrat.
English: Zalasta 2.5 mg tablets Olanzapine
Maltese: Zalasta 2.5 mg pilloli Olanzapine
English: Zalasta 15 mg orodispersible tablets Each orodispersible tablet contains 1.50 mg aspartame.
Maltese: Zalasta 15 mg pilloli li jinħallu fil-ħalq Kull pillola fiha 1.50 mg aspartame.
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: 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 xahar tal-koterapija f'pazjenti b'episodji manijaċi jew imħallta stabilizzati b'olanzapine flimkien ma' stabilizzatur tal-burdata (litju jew valproate), il-ko-terapija fit-tul ta' olanzapine mal-litju jew valproate ma kinitx superjuri b'mod statistikament sinjifikanti għal-litju jew għal valproate fit-tbegħid tarrikorrenzabipolari, definita skond il-kriterji (dijanjostiċi) tas-sindromu.
English: Zalasta 5 mg orodispersible tablets Each orodispersible tablet contains 0.50 mg aspartame.
Maltese: Zalasta 5 mg pilloli li jinħallu fil-ħalq Kull pillola fiha 0.50 mg aspartame.
English: Zalasta 5 mg tablets
Maltese: Zalasta 5 mg pilloli
English: Zalasta tablets contain lactose.
Maltese: Il-pilloli Zalasta jkun fihom il-lactose.
English: Zalasta 7.5 mg orodispersible tablets Each orodispersible tablet contains 0.75 mg aspartame.
Maltese: Zalasta 7.5 mg pilloli li jinħallu fil-ħalq Kull pillola fiha 0.75 mg aspartame.
English: In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/hr).
Maltese: Meta tqabblu n-nisa ma' l-irġiel, il-half-life ta' l-eliminazzjoni terminali medja kienet ftit jew wisq itwal fin-nisa (36.7 siegħa u 32.3 siegħa rispettivament) u r-rata ta' tneħħija tnaqqset (18.9 u 27.3 litru fis-siegħa rispettivament).
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 tal-prevenzjoni tar-rikorrenza, li dam 12-il xahar, f'pazjenti b'episodji manijaċi li kienu għaddew minn remissjoni b'kombinazzjoni ta' olanzapine u litju u mbagħad tqassmu b'mod każwali filgrupp ta' olanzapine jew f'dak tal-litju waħdu, olanzapine kien statistikament mhux inferjuri għal-litju fuq il-punt finali primarju tar-rikorrenza bipolari (olanzapine 30.0%, litju 38.3%; p=0.055).
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: Isċitokromi P450-CYP 1A2 u P450-CYP2D6 jikkontribwixxu għall-formazzjoni tal-metaboliti
English: Zalasta 20 mg tablets Olanzapine
Maltese: Zalasta 20 mg pilloli Olanzapine
English: Thromboembolism
Maltese: Tromboċitopenija
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Maltese: In-newtropenja kienet ukoll irrappurtata komunement meta olanzapine u valproate ntużaw flimkien (ara sezzjoni 4.8).
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Epistassi
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: While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Maltese: Meta olanzapine wera attività antikolinerġika in vitro, l-esperjenza waqt l-istudji kliniċi wriet inċidenza ta' avvenimenti relatati.
English: Zalasta 10 mg orodispersible tablets Each orodispersible tablet contains 1.00 mg aspartame.
Maltese: Zalasta 10 mg pilloli li jinħallu fil-ħalq Kull pillola fiha 1.00 mg aspartame.
English: Each tablet contains 323.5 mg lactose.
Maltese: Zalasta 20 mg pilloli Kull pillola fiha 323.5 mg lactose.
English: 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: 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: 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 epatika moderata (ċirrożi, Child-Pugh Klassi A jew B), id-doża inizjali għandha tkun ta' 5 mg u tiżdied biss b'kawtela.
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 %), ≥ 15% kienet komuni (4.2 %) u ≥ 25 % ma kinitx komuni (0.8 %).
English: orodispersible tablet
Maltese: Żieda filpiż
English: 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 (≥7 mmol/l).
English: Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blisters (Alu/OPA/Alu/PVC).
Maltese: Zalasta pilloli li jinħallu fil-ħalq huma disponibbli f'kaxxi ta' 14, 28, 35, 56 jew 70 pillola f'pakketti ta' folji (Alu/OPA/Alu/PVC).
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 tassoltu (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 fillibido fl-irġiel u fin-nisa jew disfunzjoni erettili fl-irġiel.
English: Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (<1.69 mmol/l) li żdiedu għal għoljin (≥2.26 mmol/l).
English: Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (<5.17 mmol/l) li żdiedu għal għoljin (≥6.2 mmol/l).
English: How to take Zalasta
Maltese: FOLJA GĦAL ZALASTA
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: Zalasta 7.5 mg tablets Each tablet contains 7.5 mg olanzapine.
Maltese: Zalasta 7.5 mg pilloli Kull pillola fiha 7.5 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: Fil-każ ta' pazjenti li jkollhom episodju ta' manija li jkun irrisponda għat-trattament b'olanzapine, olanzapine hu indikat għall-prevenzjoni tar-rikorrenza f'pazjenti bid-disturb bipolari (ara sezzjoni 5.1).
English: 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: 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: Zalasta 2.5 mg tablets Each tablet contains 2.5 mg olanzapine.
Maltese: Zalasta 2.5 mg pilloli Kull pillola fiha 2.5 mg olanzapine.
English: Zalasta 5 mg tablets Olanzapine
Maltese: Zalasta 5 mg pilloli Olanzapine
English: Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and urinary incontinence were observed commonly.
Maltese: Il-pulmonite, iż-żieda fit-temperatura tal-ġisem, il-letarġija, l-eritema, lalluċinazzjonijiet viżivi u l-inkontinenza ta' l-awrina kienu komunement osservati.
English: Zalasta 15 mg tablets Olanzapine
Maltese: Zalasta 15 mg pilloli Olanzapine
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 talġisem seħħet f' 17.4% tal-pazjenti waqt it-trattament akut (sa 6 ġimgħat).
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' eċitament jew ewforija eċitament jew ewforija.
English: Each tablet contains 20 mg olanzapine.
Maltese: Kull pillola fiha 20 mg olanzapine.
English: The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Maltese: Il-proporzjon ta' pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż-żieda fil-piż, fil-glucose, filkolesterol totali/LDL/HDL jew trigliċeridi żdied maż-żmien.
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: Kien hemm anemija, tromboċitopenija jew newtropenja riversibbli f'xi klieb ittrattati b' 8 jew 10 g/kg kuljum (esponiment totali għal olanzapine [AUC] ta' bejn 12- u 15-il darba ikbar minn dik ta' raġel li ngħata doża ta' 12-il mg.
English: Each tablet contains 7.5 mg olanzapine.
Maltese: Kull pillola fiha 7.5 mg olanzapine.
English: Zalasta 10 mg tablets Olanzapine
Maltese: Zalasta 10 mg pilloli Olanzapine
English: Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Maltese: Fl-annimali gerriema, is-sinjali ta' tossiċità orali kienu karatteristiċi ta' komposti newrolettiċi potenti: attività baxxa, koma, rogħda, konvulżjonijiet kloniċi, ħruġ ta' ħafna bżieq, u nuqqas ta' żieda fil-piż.
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 pazjent bl-iskiżofrenija ta' iktar minn 65 sena, dożi ta' bejn 5 u 20 mg kuljum ma kinux assoċjati ma' xi profil partikolari ta' avvenimenti sekondarji ħżiena.
English: CARTON FOR ZALASTA 20 mg TABLETS
Maltese: KARTUNA GĦAL ZALASTA 20 mg PILLOLI
English: CARTON FOR ZALASTA 7.5 mg TABLETS
Maltese: KARTUNA GĦAL ZALASTA 7.5 mg PILLOLI
English: Mutagenicity
Maltese: Ipotermija
English: Each tablet contains 2.5 mg olanzapine.
Maltese: Kull pillola fiha 2.5 mg olanzapine.
English: EU/1/07/415/022 (14 tablets) EU/1/07/415/023 (28 tablets) EU/1/07/415/024 (35 tablets) EU/1/07/415/025 (56 tablets) EU/1/07/415/026 (70 tablets)
Maltese: EU/1/07/415/022 (14-il pillola) EU/1/07/415/023 (28 pillola) EU/1/07/415/024 (35 pillola) EU/1/07/415/025 (56 pillola) EU/1/07/415/026 (70 pillola)
English: Zalasta 20 mg orodispersible tablets EU/1/07/415/052-056
Maltese: Zalasta 20 mg pilloli li jinħallu fil-ħalq EU/1/07/415/052-056
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/kg).
Maltese: L-espożizzjoni (mg/kg) medja fit-trabi fl-istat fiss kienet stimata li kienet 1.8% tad-doża ta' olanzapine fl-omm.
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 sezzjonijiet 4.8 u 5.1).
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in 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 filkomportament, dovut għal żieda fil-mortalità u r-riskju ta' inċident ċerebro-vaskulari.
English: In this leaflet:
Maltese: Episodji ta' manija:
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 Urinary hesitation
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Inkontinenza urinarja, żamma tal-urina
English: Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Maltese: 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: 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: 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 fissider fl-irġiel u fin-nisa bħal produzzjoni mhux normali ta' ħalib mis-sider jew tkabbir mhux normali.
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). il-pazjenti 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: EU/1/07/415/027 (14 tablets) EU/1/07/415/028 (28 tablets) EU/1/07/415/029 (35 tablets) EU/1/07/415/030 (56 tablets) EU/1/07/415/031 (70 tablets)
Maltese: EU/1/07/415/027 (14-il pillola) EU/1/07/415/028 (28 pillola) EU/1/07/415/029 (35 pillola) EU/1/07/415/030 (56 pillola) EU/1/07/415/031 (70 pillola)
English: Each orodispersible tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine.
Maltese: Kull pillola li tinħall fil-ħalq fiha 5 mg, 7.5 mg, 10 mg, 15 mg jew 20 mg olanzapine
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Maltese: Każijiet rari li ġew rappurtati bħala NMS kienu rrappurtati f'assoċjazzjoni ma' olanzapine ukoll. Manifestazzjonijiet kliniċi ta' NMS huma deni għoli, ebusija tal-muskoli, stat mentali alterat u evidenza ta' instabbiltà awtonomika (pressjoni tad-demm jew tal-polz irregolari, takikardija, dijaforeżi, u taħbit talqalb irregolari).
English: Zalasta 20 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 20.
Maltese: Zalasta 20 mg pilloli huma: tondi, daqsxejn konvessi, jagħtu fl-isfar possibbilment b'tikek sofor individwali bl-iskrizzjoni 20.
English: Zalasta 10 mg tablets: available in boxes of 7, 14, 28, 35, 56 and 70 tablets in blisters.
Maltese: Zalasta 10 mg pilloli: disponibbli f'kaxxi ta' 7, 14, 28, 35, 56 u 70 pillola f'pakketti ta' folji.
English: EU/1/07/415/011 (14 tablets) EU/1/07/415/012 (28 tablets) EU/1/07/415/013 (35 tablets) EU/1/07/415/014 (56 tablets) EU/1/07/415/015 (70 tablets)
Maltese: EU/1/07/415/011 (14-il pillola) EU/1/07/415/012 (28 pillola) EU/1/07/415/013 (35 pillola) EU/1/07/415/014 (56 pillola) EU/1/07/415/015 (70 pillola)
English: Zalasta 10 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 7, 14, 28, 35, 56 or 70 tablets in a box.
Maltese: Zalasta 10 mg pilloli Pakkett ta' folji (OPA/Alu/PVC, Alu-foil): 7, 14, 28, 35, 56 jew 70 pillola f'kaxxa.
English: Zalasta 7.5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 7.5.
Maltese: Zalasta 7.5 mg pilloli huma: tondi, daqsxejn konvessi, jagħtu fl-isfar possibbilment b'tikek sofor individwali bl-iskrizzjoni 7.5.
English: The metabolism of olanzapine may be induced by smoking.
Maltese: Ilmetaboliżmu ta' olanzapine jista' jiżdied bit-tipjip.
English: Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials.
Maltese: Għalkemm ma ġewx imwettqa studji kliniċi magħmulin biex iqabblu l-adolexxenti ma' l-adulti, informazzjoni mill-istudji ta' ladolexxenti ġiet imqabbla ma' dik ta' l-istudji ta' l-adulti.
English: Each tablet contains 10 mg olanzapine.
Maltese: Kull pillola fiha 10 mg olanzapine.
English: BLISTER FOR ZALASTA 20 mg TABLETS
Maltese: FOLJA GĦAL ZALASTA 20 mg PILLOLI
English: BLISTER FOR ZALASTA 10 mg TABLETS
Maltese: FOLJA GĦAL ZALASTA 10 mg PILLOLI
English: Pull up the edge of the foil and peel foil off completely.
Maltese: Iġbed it-tarf tal-fojl u neħħiha kompletament.
English: Renal and urinary disorders
Maltese: Eżitazzjoni urinarja
English: EU/1/07/415/006 (14 tablets) EU/1/07/415/007 (28 tablets) EU/1/07/415/008 (35 tablets) EU/1/07/415/009 (56 tablets) EU/1/07/415/010 (70 tablets)
Maltese: EU/1/07/415/006 (14-il pillola) EU/1/07/415/007 (28 pillola) EU/1/07/415/008 (35 pillola) EU/1/07/415/009 (56 pillola) EU/1/07/415/010 (70 pillola)
English: Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Maltese: Olanzapine wera wkoll vantaġġ statistikament sinjifikanti fuq il-plaċebo f'termini tal-prevenzjoni tar-rikorrenza tal-manija jew tar-rikorrenza tad-dipressjoni.
English: Zalasta 20 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Maltese: Zalasta 20 mg pilloli: disponibbli f'kaxxi ta'14, 28, 35, 56 u 70 pillola f'pakketti ta' folji.
English: Each tablet contains 15 mg olanzapine.
Maltese: Kull pillola fiha 15 mg olanzapine.
English: Zalasta 20 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Maltese: Zalasta 20 mg pilloli Pakkett ta' folji (OPA/Al/PVC, Al-foil): 14, 28, 35, 56 jew 70 pillola f'kaxxa.
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Maltese: Il-pillola li tinħall fil-ħalq ta' olanzapine hija bijoekwivalenti għal pilloli olanzapine, b'rata u estensjoni simili tal-assorbiment simili.
English: Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Maltese: Ġiet osservata żieda fil-piż klinikament sinifikanti fil-kategoriji kollha fil-linja bażi ta' l-Indiċi tal-Massa tal-Ġisem (BMI).
English: There is a risk of feeling drowsy when you are given Zalasta.
Maltese: Hemm riskju li tħossok imħeddel meta tingħata Zalasta.
English: CARTON FOR ZALASTA 15 mg TABLETS
Maltese: KARTUNA GĦAL ZALASTA 15 mg PILLOLI
English: What Zalasta looks like and contents of the pack Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are: round, slightly biconvex, yellow marbled tablets with possible individual spots.
Maltese: Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg jew 20 mg pilloli li jinħallu fil-ħalq huma tondi, kemxejn konvessi, sofor irħamati bil-possibbiltà ta' tikek individwali.
English: Rhabdomyolysis
Maltese: Il-Manifattur
English: CARTON FOR ZALASTA 10 mg TABLETS
Maltese: KARTUNA GĦAL ZALASTA 10 mg PILLOLI
English: Zalasta 7.5 mg orodispersible tablets EU/1/07/415/037-041
Maltese: Zalasta 7.5 mg pilloli li jinħallu fil-ħalq EU/1/07/415/037-041