FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60 %.
Maltese: It-teħid flimkien mal-faħam attivat wera li jnaqqas il-biodisponibilità orali ta' olanzapine b' 50% sa 60%.
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: In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr).
Maltese: F'pazjenti li ma jpejpux f'paragun ma' dawk li jpejpu (irġiel u nisa) il-medja tal-half life ta' l-eliminazzjoni kien imtawwal (38.6 kontra 30.4 siegħa) u l-clearance tnaqqset (18.6 kontra 27.7 l/hr).
English: As it exhibits in vitro dopamine antagonism, olanzapine may antagonise 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: PHARMACEUTICAL FORM AND CONTENTS Multipack 70 (2 packs of35) film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 70 (2 × 35) pilloli miksijin b'rita
English: Hepatitis (including hepatocellular, cholestatic or mixed liver injury)11
Maltese: Epatite (inkluż mard tal-fwied tattip epatoċellulari, kolestatiku jew tat-tnejn flimkien)11
English: In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Maltese: Fi studji sa 3 xhur fil-ġrieden u sa sena fil-firien u fil-klieb, l-effetti li ippredominaw kienu d-depressjoni CNS, effetti antikolinerġiċi, u diżordnijiet periferali ematoloġiċi.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Madankollu, id-detentur talawtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott jekk il-prodott huwa inkluż fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Pharmaceutical Trading Co. Ltd. Τηλ: +357 99403969
Maltese: Τηλ: +357 99403969
English: Seizures
Maltese: Disartrja
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 l-effetti ta' l-antagonisti ta' dopamine diretti jew indiretti.
English: Reproductive system and breast disorders Erectile dysfunction in males
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Disfunzjoni talerezzjoni fl-irġiel
English: Neutropenia10
Maltese: Newtropenija10
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 t' antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il-komportament farmakokinetiku ta' olanzapine.
English: The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin.
Maltese: Il-kisja tar-rita ta' kull pillola ta' 7.5 mg fiha 0.18 mg ta' soya lecithin.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Maize starch, pregelatinised Crospovidone (Type A) Magnesium stearate
Maltese: Lactose monohydrate Lamtu tal-qamħirrum Lamtu tal-qamħirrum preġelatinizzat Crospovidone (Tip A) Stjerejt tal-Manjezju
English: Olanzapine Mylan 7.5 mg is available in packs containing 28 x 1, 56 x 1, 98 x and 100 x 1 filmcoated tablets.
Maltese: L-Olanzapine Mylan ta' 7.5 mg jinbieghu f'pakketti ta' 28 × 1, 56 × 1, 98 × 1 u 100 × 1 pillola miksija b'rita.
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: The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Maltese: Id-dożi medjani li jwasslu għall-mewt kienu bejn wieħed u ieħor 210 mg/kg (ġrieden) u 175 mg/kg (firien).
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: ]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: Reproductive toxicity
Maltese: Tossiċità fuq is-sistema riproduttiva
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 5 mg u tiżdied biss b'kawtela.
English: Dyskinesia6
Maltese: Diskineżja6
English: Controlled efficacy data in adolescents (ages 13 to 17 years) are limited to short term studies in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Maltese: Fl-adolexxenti (minn 13 sa 17-il sena), dejta kkontrollata ta' effikaċja hija limitata għal studji ta' tul qasir ta' żmien fl-iskiżofrenja (6 ġimgħat) u manija assoċjata ma' mard bipolari tat-tip I (3 ġimgħat) u li involvew anqas minn 200 adolexxent.
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 simpatomimatiċi b' attività beta-agonista għax l-istimulazzjoni beta tista' taggrava l-pressjoni baxxa.
English: There is no specific antidote for olanzapine.
Maltese: Ma hemm ebda antidotu speċifiku għal olanzapine.
English: Blisters:
Maltese: Skiżofrenja:
English: Oestrous 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: • medicines for Parkinson's disease.
Maltese: • mediċini għall-marda ta' Parkinson.
English: Each film-coated tablet contains 76 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 76 mg lactose (bħala monohydrate).
English: Cold-formed aluminium/aluminium blister in cartons of 7 (10 mg only), 10, 28, 30, 35, 56, 70 and multipacks containing 70 (2 packs of 35) film-coated tablets.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folja maħduma bierda ta' aluminju/aluminju f'kaxex ta' 7 (10 mg biss), 10, 28, 30, 35, 56, 70 u pakketti multipli li fihom 70 (2 pakketti ta' 35) pillola miksija b'rita.
English: Olanzapine Mylan 2.5 mg, 15 mg and 20 mg is available in packs containing 28 x 1 film-coated tablets.
Maltese: L-Olanzapine Mylan tal-2.5 mg, 15 mg u 20 mg jinbiegħu f'pakketti ta' 28 × 1 pillola miksija b'rita.
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Maltese: Il-grad ta' tibdil fil-kolesterol totali waqt is-sawm, kolesterol tat-tip LDL, trigliċeridi, u prolactin (ara sezzjonijiet 4.4 u 4.8) kien akbar fl-adolexxenti milli fl-adulti.
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 pri-ezistenti ta' disturbi akuti u movimenti tardivi ekstrapiramidali, fil-preżent ma jistax jiġi konkluż li olanzapine jipproduċi anqas diskineżja tardiva u/jew sindromi ekstrapiramidali tardivi oħra.
English: 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: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Agenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
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 ilfarmakokinetika 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: 10 film-coated tablets 28 film-coated tablets 30 film-coated tablets 35 film-coated tablets 56 film-coated tablets 70 film-coated tablets 28 x 1 film-coated tablets 98 x 1 film-coated tablets
Maltese: 10 pilloli miksijin b'rita 28 pilloli miksijin b'rita 30 pilloli miksijin b'rita 35 pilloli miksijin b'rita 56 pilloli miksijin b'rita 70 pilloli miksijin b'rita 28 × 1 pilloli miksijin b'rita 98 × 1 pilloli miksijin b'rita
English: The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin.
Maltese: Il-kisja tar-rita ta' kull pillola ta' 10 mg fiha 0.24 mg ta' soya lecithin.
English: The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin.
Maltese: Ir-rita tal-kisja ta' kull pillola ta' 2.5 mg fiha 0.06 mg soya lecithin.
English: 12.2 mm x 6.7 mm, ellipse-shaped, normal convex, white film-coated tablets debossed “OZ 15” on one side and “G” on the other side.
Maltese: Pilloli miksija b'rita ta' 12.2 mm × 6.7 mm, b'forma ta' ellissi, konvessi normali, ta' kulur abjad, imnaqqxin b'“OZ 15” fuq naħa waħda u “G” fuq in-naħa l-oħra.
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 selettivament naqqas l-attività mesolimbiċi tan-newroni dopaminerġiċi (A10) waqt li kellu ftit effett fuq il-passaġġ (A9) tal-corpus striatum involuti fil-funzjoni motorjali.
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; stuttering; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) jinkludu sensittività eċċessiva (eż. nefħa fil-ħalq u l-gerżuma, ħakk, raxx); dijabete jew aggravament tad-dijabete, xi kultant assoċjata ma' ketoaċidożi (ketoni fid-demm u fl-awrina) jew koma; aċċessjonijiet, normalment assoċjati ma' storja medika ta' aċċessjonijiet (epilessija); ebusija fil-muskoli jew spażmi (li jinkludu movimenti tal-għajnejn); sindromu ta' saqajn irrikwieti; problemi biex titkellem; temtim; il-qalb tħabbat bil-mod; sensittività għad-dawl tax-xemx; ħruġ ta' demm mill-imnieħer; nefħa addominali; telf ta' memorja jew 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: 13.4 mm x 7.3 mm, ellipse-shaped, normal convex, white film-coated tablets debossed “OZ 20” on one side and “G” on the other side.
Maltese: Pilloli miksija b'rita ta' 13.4 mm × 7.3 mm, b'forma ta' ellissi, konvessi normali, ta' kulur abjad, imnaqqxin b'“OZ 20” fuq naħa waħda u “G” fuq in-naħa l-oħra.
English: Photosensitivity reaction
Maltese: Reazzjoni ta' fotosensittività Alopeċja
English: The daily dose of olanzapine is between 5 mg and 20 mg.
Maltese: Id-doża ta' kuljum ta' OLANZAPINE MYLAN hija bejn 5 mg u 20 mg.
English: QTc interval
Maltese: L-Intervall QTc
English: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Maltese: M'hemmx dejta kkontrollata dwar il-manteniment tal-effett jew dwar is-sigurtà fit-tul (ara sezzjonijiet 4.4 u 4.8).
English: - The active substance is olanzapine.
Maltese: • Is-sustanza attiva hi l-olanżapin.
English: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Maltese: 15 Tibdil fil-livelli tal-kolesterol totali waqt is-sawm minn normal fil-linja bażi (< 4.39 mmol/l) għal għoljin (≥ 5.17 mmol/l) kienu komuni.
English: Olanzapine Mylan 7.5 mg film-coated tablets
Maltese: OLANZAPINE MYLAN 7.5 mg pilloli Olanzapine
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: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Maltese: 3 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 5.17 mmol/l) li żdiedu għal għoljin (≥ 6.2 mmol/l).
English: INFORMATION IN BRAILLE Olanzapine 7.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine 7.5 mg
English: Tardive dyskinesia11
Maltese: Diskineżja tardiva11
English: The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Maltese: Fit-tabella li ġejja huma mniżżla r-reazzjonijiet avversi u t-testijiet tal-laboratorju osservati minn rapporti magħmula b'mod spontanju u minn studji kliniċi.
English: Potential interactions affecting olanzapine
Maltese: Potenzjal t'interazzjonijiet ma' 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 (≥ 7 mmol/l).
English: Dogs tolerated single oral doses up to 100 mg/kg without mortality.
Maltese: Il-klieb felħu dożi orali b'wahdiet sa 100 mg/kg mingħajr mortalità.
English: In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated 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: 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: In the same clinical trials, cerebrovascular adverse events (CVAE e.g., stroke, transient ischaemic 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: Metabolism and nutrition disorders Weight gain1 Elevated cholesterol levels2,3
Maltese: Livelli għolja ta' kolesterol2,3
English: Danmark BGP Products ApS Tlf: +45 28116932
Maltese: Tlf: +45 28116932
English: Each film-coated tablet contains 183 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 183 mg ta' lactose (bħala monohydrate).
English: 10 As assessed by measured values from clinical trials in the Olanzapine Integrated Database.
Maltese: Kif evalwat minn valuri mkejla minn provi kliniċi fid-Database Integrata ta' Olanzapine.
English: INFORMATION IN BRAILLE Olanzapine 2.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE OLANZAPINE 2.5 mg
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 bil-plaċebo (ara sezzjoni 4.8), u olanzapine ma kienx aktar effettiv mill-plaċebo fit-trattament tas-sintomi psikotiċi.
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 sezzjoni 4.4).
English: The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin.
Maltese: Il-kisja tar-rita ta' kull pillola ta' 20 mg fiha 0.20 mg ta' soya lecithin.
English: 5 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: 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, xaħmijiet fid-demm u kmieni fil-kura, żidiet temporanji fl-enzimi tal-fwied; żidiet fil-livelli ta' zokkor fid-demm u fl-awrina; żidiet fil-livelli ta' uric acid u creatine phosphokinase fiddemm; tħossok aktar bil-ġuħ; sturdament; irrekwitezza; rogħda; movimenti mhux tas-soltu (diskinesiji); stitikezza; ħalq xott; raxx; titlef il-forzi; għeja estrema; retenzjoni tal-ilma li twassal għal nefħa fl-idejn, għekiesi jew saqajn; deni; uġigħ fil-ġogi; u disfunzjonijiet sesswali bħal tnaqqis fillibido fl-irġiel u fin-nisa jew disfunzjoni erettili fl-irġiel.
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, fil-kolesterol totali/LDL/HDL jew trigliċeridi żdied maż-żmien.
English: Each film-coated tablet contains 304 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 304 mg ta' lactose (bħala monohydrate).
English: INFORMATION IN BRAILLE Olanzapine 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine 10 mg
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 ikkawżatx mutaġeniċità jew klastoġeniċità f'firxa sħiħata' testijiet standard, li nkludew testijiet ta' mutazzjoni tal-mikrobi kif ukoll testijiet fuq il-mammiferi kemm in vitro kif ukoll in vivo.
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: Olanzapine Mylan 5 mg and 10 mg is available in packs containing 28 x 1 and 98 x 1 film-coated tablets.
Maltese: L-Olanzapine Mylan tal-5 mg u 10 mg jinbiegħu f'pakketti ta' 28 × 1 u 98 × 1 pillola miksija b'rita.
English: Each film-coated tablet contains 244 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 244 mg ta' lactose (bħala monohydrate).
English: The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
Maltese: It-tabella li ġejja tiġbor fil-qosor ir-reazzjonijiet avversi rrapportati b'frekwenza akbar f'pazjenti adolexxenti (minn 13 sa 17-il sena) milli f'pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi ta' terminu qasir f'pazjenti adolexxenti.
English: Blood and lymphatic system disorders Eosinophilia
Maltese: Disturbi tad-demm u tas-sistema limfatika Eosinofilja
English: Olanzapine Mylan 2.5 mg and 5.0 mg is available in packs containing 250 and 500 film-coated tablets.
Maltese: L-Olanzapine Mylan tal-2.5 mg u tal-5.0 mg jinbiegħu f'pakketti ta' 250 u 500 pillola miksija b'rita.
English: Clinical efficacy
Maltese: Effikaċja klinika u sigurtà
English: Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
Maltese: Kienu rrappurtati b'mod mhux konuni aċċessjonijiet f'pazjenti meta trattati b'olanzapine.