FrancophonIA/ELRC3.0 huggingface dataset:
English: In kidney transplant patients, the starting daily dose is 0.2 to 0.3 mg per kilogram body weight for adults and 0.3 mg/kg for children.
Maltese: Għall-pazjenti sottoposti għal trapjant ta' kilwa, id-doża inizjali hija 0.2 sa 0.3 mg għal kull kilo tal-piż tal-ġisem għall-adulti u 0.3 mg/kg għat-tfal.
English: How is Modigraf used?
Maltese: X'inhu Modigraf?
English: Modigraf is used in adults and children who have had a kidney, liver or heart transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Maltese: Modigraf jintuża fl-adulti u fit-tfal li ġew sottoposti għal trapjant ta' kilwa, tal-fwied jew tal-qalb, biex jiġi evitat ir-rifjut (meta s-sistema immunitarja tattakka l-organu trapjantat).
English: For the full list of all side effects reported with Modigraf, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Modigraf, ara l-Fuljett ta' Tagħrif.
English: What benefit has Modigraf shown during the studies?
Maltese: X'benefiċċji wera Modigraf matul l-istudji mwettqa?
English: Because Modigraf contains granules, it allows for making fine adjustments in dosing and provides an alternative for young children and others unable to swallow capsules.
Maltese: Billi Modigraf fih il-granuli, huwa jippermetti li jsiru aġġustamenti ħfief fiddożaġġ u jservi ta' alternattiva għat-tfal żgħar u għal oħrajn li mhumiex kapaċi jibilgħu l-kapsuli.
English: It may harm them,
Maltese: Qaxxar il--wara tagħha bil-mod.
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Maltese: De la Industria 30, 28108 Alcobendas, Madrid, Spanja.
English: Manufacturer Lilly S.A., Avda.
Maltese: Manifattur Lilly S.A., Avda.
English: Date of latest renewal: 12 September 2006
Maltese: Data tal-aħħar tiġdid: 12 ta' Settembru 2006
English: ZYPREXA VELOTAB is available in packs containing 28, 35, 56, 70 or 98 tablets.
Maltese: ZYPREXA VELOTAB hu disponibbli f'pakketti ta' 28, 35, 56, 70 jew 98 pillola.
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors.
Maltese: Fi studji ta' qabel l-użu kliniku, olanzapine wera firxa ta' affinitajiet għar-riċetturi (Ki; < 100 nM) għal riċetturi ta' serotonin 5-HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; riċetturi muskariniċi kolinerġiċi M1-M5; α-1 adrenerġiċi; riċetturi histamine H1.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Maltese: komuni ( > 1/100 sa < 1/10), mhux komuni ( > 1/1,000 sa < 1/100), rari ( > 1/10,000 sa < 1/1,000, rari ħafna ( < 1/10,000), mhux magħrufa (ma jistgħux jiġu stmati mill-informazzjoni li hemm disponibbli).
English: ZYPREXA VELOTAB contains the active substance olanzapine.
Maltese: ZYPREXA VELOTAB fih is-sustanza attiva olanzapine.
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
English: Olanzapine is bound predominantly to albumin and α1-acid-glycoprotein.
Maltese: Olanzapine hija fil-biċċa 'l kbira marbuta mal-albumina u α1-aċidglycoprotein.
English: Each ZYPREXA VELOTAB orodispersible tablet contains either 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
Maltese: Kull pillola li tinħall fil-ħalq ta' ZYPREXA VELOTAB għandha 5 mg, 10 mg, 15 mg jew 20 mg tas-sustanza attiva.
English: 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
Maltese: 28 pillola li jinħallu fil-ħalq 35 pillola li jinħallu fil-ħalq 56 pillola li jinħallu fil-ħalq 70 pillola li jinħallu fil-ħalq 98 pillola li jinħallu fil-ħalq
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' l assoċjati sintomi dipressivi (medja ta' punteġg ta' 16.6 meħud fil-bidu tal-kura skond 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: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPREXA VELOTAB dose.
Maltese: • Carbamazepine (anti-epilettiku u stabilizzatur tal-burdata), fluvoxamine (anti-dipressant),
English: EU/1/99/125/001 EU/1/99/125/002 EU/1/99/125/003 EU/1/99/125/004 EU/1/99/125/005
Maltese: EU/1/99/125/001 EU/1/99/125/002 EU/1/99/125/003 EU/1/99/125/004
English: Glutamyltransferase
Maltese: Glutamyltransferase għoli10
English: Other ingredients: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
Maltese: Ingredjenti oħra: gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
English: Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358 (0)9 8545 250
Maltese: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32 (0)2 548 84 84
English: ZYPREXA VELOTAB contains aspartame, mannitol and sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
Maltese: ZYPREXA VELOTAB fih aspartame, mannitol u sodium methyl parahydroxybenzoate u sodium propyl parahydroxybenzoate
English: The most frequently (seen in ≥ 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Maltese: Fi studji kliniċi, l-aktar reazzjonijiet avversi li ġew irrapportati b'mod frekwenti (jidhru f'> 1% talpazjenti) u li huma assoċjati ma' l-użu ta' l-olanzapine kienu sonnolenza, żieda fil-piż, eosinofilja, livelli għolja ta' prolactin, kolesterol, glucose u trigliċeridi (ara taqsima 4.4), glukosurja, żieda fl-aptit, sturdament, akatiżja, parkinsoniżmu, lewkopenija, newtropenija (ara taqsima 4.4), diskineżja,
English: ZYPREXA VELOTAB with alcohol
Maltese: ZYPREXA VELOTAB mal-alkoħol
English: PC: {number} SN: {number} NN: {number}
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih
English: (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 taqsima 4.4)
English: < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Maltese: < 2.26 mmol/l) għal għoljin (≥ 2.26 mmol/l) kienu komuni ħafna.
English: • The other ingredients are - gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217).
Maltese: • Is-sustanzi l-oħra huma gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219) u sodium propyl parahydroxybenzoate (E217).
English: Aluminium blister strips in cartons of 28, 35, 56, 70 or 98 orodispersible tablets per carton.
Maltese: Strixxi tal-fojlj ta' l-aluminju f'pakketti ta' 28, 35, 56, 70 jew 98 pillola li jinħallu fil-ħalq f'kull pakkett.
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 ta' 12-il xhar dwar ir-rikorrenza preventiva f'pazjenti b'episodju ta' manija li kienu ikkontrollati b'olanzapine u l-lithium flimkien, kienu mbagħad mqassmin mingħajr għażla u mogħtija olanzapine jew il-lithium waħdu. olanzapine kien statistikament mhux inferjuri għall-lithium fuq l għan ewlieni ta' rikorrenza bipolari (olanzapine 30.0%, lithium 38.3%; p = 0.055).
English: May be harmful for people with phenylketonuria.
Maltese: Tista' tkun ta' periklu għal nies b'phenylketonuria.
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 dijabete li tmur għall-agħar, 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); sindrome ta' saqajn irrekwieti; problemi fil-mod kif titkellem; temtim; il-qalb tħabbat bil mod; sensittività għad-dawl tax-xemx; tinfaraġ; l-addome jintefaħ; titlef il-memorja jew tibda tinsa; inkontinenza urinarja; nuqqas ta' kapaċità li tgħaddi l-urina; jaqa' x-xagħar; nuqqas ta' jew tnaqqis filmestrwazzjoni u tibdil fis-sider fl-irġiel u fin-nisa bħal produzzjoni mhux normali ta' ħalib mis-sider jew tkabbir mhux normali.
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: INFORMATION IN BRAILLE ZYPREXA VELOTAB 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ZYPREXA VELOTAB 20 mg
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: ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets
Maltese: ZYPREXA VELOTAB 5 mg pilloli li jinħallu fil-ħalq ZYPREXA VELOTAB 10 mg pilloli li jinħallu fil-ħalq ZYPREXA VELOTAB 15 mg pilloli li jinħallu fil-ħalq ZYPREXA VELOTAB 20 mg pilloli li jinħallu fil-ħalq
English: Do not take ZYPREXA VELOTAB
Maltese: Tiħux ZYPREXA VELOTAB
English: Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Maltese: Fluvoxamine, inibitur speċifiku ta'CYP1A2, deher li jinibixxi sinifikatament il-metaboliżmu ta'
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l
Maltese: Tibdil fit-trigliċeridi waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 1.69 mmol/l
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: f'pazjenti ttattati b'olanzapine, meta mqabblin ma' pazjenti ttrattati bil-plaċebo (1.3% kontra 0.4%,
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPREXA VELOTAB.
Maltese: • Livell għoli ta' zokkor fid-demm u livelli għolja ta' xaħmijiet (trigliċeridi u kolesterol) instabu f'pazjenti li qed jieħdu ZYPREXA VELOTAB.
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 tas-soltu (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 fil-libido fl-irġiel u fin-nisa jew disfunzjoni erettili fl-irġiel.
English: Mannitol ZYPREXA VELOTAB orodispersible tablet contains mannitol.
Maltese: ZYPREXA VELOTAB pillola li tinħall fil-ħalq fiha mannitol.
English: Patients treated with any antipsychotic medicines, including ZYPREXA VELOTAB, 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 VELOTAB, 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: EU/1/99/125/006 EU/1/99/125/007 EU/1/99/125/008 EU/1/99/125/009 EU/1/99/125/010 EU/1/99/125/011 EU/1/99/125/012 EU/1/99/125/013 EU/1/99/125/014 EU/1/99/125/015 EU/1/99/125/016 EU/1/99/125/017 EU/1/99/125/018 EU/1/99/125/019 EU/1/99/125/020
Maltese: EU/1/99/125/005 EU/1/99/125/006 EU/1/99/125/007 EU/1/99/125/008 EU/1/99/125/009 EU/1/99/125/010
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: Other medicines and ZYPREXA VELOTAB
Maltese: Mediċini oħra u ZYPREXA VELOTAB
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 l-alluċinazzjonijiet kienu rrappurtati b'mod komuni ħafna u aktar ta' spiss milli bil plaċebo (ara taqsima 4.8), u olanzapine ma kienx aktar effettiv mill-plaċebo fit-trattament tas-sintomi psikotiċi.
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ZYPREXA VELOTAB 5 mg
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: 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 taqsimiet 4.8 u 5.1).
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ZYPREXA VELOTAB 15 mg
English: Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate Olanzapine orodispersible tablet contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
Maltese: Sodium methyl parahydroxybenzoate u sodium propyl parahydroxybenzoate
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: 7% mil-linja bażi tal-piż tal-ġisem seħħet f' 17.4% tal-pazjenti waqt it-trattament akut (sa 6 ġimgħat).
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: fil-kolesterol totali/LDL/HDL jew trigliċeridi żdied maż-żmien.
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ZYPREXA VELOTAB 10 mg
English: ZYPREXA VELOTAB orodispersible tablet contains aspartame, which is a source of phenylalanine.
Maltese: ZYPREXA VELOTAB pillola li tinħall fil-ħalq għandha l-aspartame, li hija sors ta' phenylalanine.
English: Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Maltese: 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: Children and adolescents ZYPREXA VELOTAB is not for patients who are under 18 years.
Maltese: Tfal u adolexxenti ZYPREXA VELOTAB mhux għal pazjenti li għandhom anqas minn 18-il sena.
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' l-adolexxenti ġiet imqabbla ma' dik ta' l-istudji ta' l-adulti.
English: ZYPREXA VELOTAB 20 mg orodispersible tablets
Maltese: ZYPREXA VELOTAB 20 mg, pilloli li jinħallu fil-ħalq
English: ZYPREXA VELOTAB 5 mg orodispersible tablets
Maltese: ZYPREXA VELOTAB 5 mg, pilloli li jinħallu fil-ħalq
English: The daily dose of ZYPREXA VELOTAB is between 5 mg and 20 mg.
Maltese: Id-doża ta' kuljum ta' ZYPREXA VELOTAB hija bejn 5 mg u 20 mg.
English: High Gamma
Maltese: GĦAMLA KWALITATTIVA
English: Patients who cannot take phenylalanine should note that ZYPREXA VELOTAB contains aspartame, which is a source of phenylalanine.
Maltese: Pazjenti li ma jistgħux jieħdu Phenylalanine għandhom jinnutaw illi ZYPREXA VELOTAB fiha l aspartame, li huwa mibdul f'Phenylalanine fil-ġisem.
English: m.b.H.
Maltese: malajr.
English: Patients who cannot take mannitol should note that ZYPREXA VELOTAB contains mannitol.
Maltese: Pazjenti li ma jistgħux jieħdu mannitol għandhom jinnutaw illi ZYPREXA VELOTAB fiha mannitol.
English: EU/1/99/125/004 28 orodispersible tablets EU/1/99/125/012 35 orodispersible tablets EU/1/99/125/008 56 orodispersible tablets EU/1/99/125/016 70 orodispersible tablets EU/1/99/125/020 98 orodispersible tablets
Maltese: EU/1/99/125/004 28 pillola li tinħall fil-ħalq EU/1/99/125/012 35 pillola li tinħall fil-ħalq EU/1/99/125/008 56 pillola li tinħall fil-ħalq EU/1/99/125/016 70 pillola li tinħall fil-ħalq EU/1/99/125/020 98 pillola li tinħall fil-ħalq
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 20 mg orodispersible tablets Olanzapine
Maltese: Kull pillola li tinħall fil-ħalq fiha 20 mg ta' olanzapine
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna) jinkludu titbaxxa t-temperatura normali tal-ġisem; ritmi mhux normali tal-qalb; mewt għall-għarrieda u inspjegabbli; infjammazjoni tal-frixa li tikkawża wġigħ qawwi fl-istonku, deni u taqlib; mard tal-fwied li jidher bħala sfurija tal ġilda u tal-abjad tal-għajnejn; mard fil-muskoli li jippreżenta ruħu bħala wġigħ li m'għandux spjegazzjoni; u erezzjoni mtawla u/jew bl-uġigħ.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 February 2000
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONIJI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 3 ta' Frar 2000
English: If this happens, contact your doctor at once.
Maltese: Aċċessjonijiet li fil maġġoranza tagħhom kien rrappurtat passat mediku ta'
English: ZYPREXA VELOTAB 15 mg orodispersible tablets
Maltese: ZYPREXA VELOTAB 15 mg, pilloli li jinħallu fil-ħalq
English: ZYPREXA VELOTAB 10 mg orodispersible tablets
Maltese: ZYPREXA VELOTAB 10 mg, pilloli li jinħallu fil-ħalq
English: EU/1/99/125/003 28 orodispersible tablets EU/1/99/125/011 35 orodispersible tablets EU/1/99/125/007 56 orodispersible tablets EU/1/99/125/015 70 orodispersible tablets EU/1/99/125/019 98 orodispersible tablets
Maltese: EU/1/99/125/003 28 pillola li tinħall fil-ħalq EU/1/99/125/011 35 pillola li tinħall fil-ħalq EU/1/99/125/007 56 pillola li tinħall fil-ħalq EU/1/99/125/015 70 pillola li tinħall fil-ħalq EU/1/99/125/019 98 pillola li tinħall fil-ħalq