FrancophonIA/ELRC3.0 huggingface dataset:
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 rrappurtati bi 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: Dogs tolerated single oral doses up to 100 mg/kg without mortality.
Maltese: Il-klieb felħu dożi orali waħidhom sa 100 mg/kg u għexu.
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 (inċidenza > 10%) jinkludu takikardija, aġitazzjoni/aggressività, diżartrija, sintomi ekstrapiramidali varji, u telf tas-sensi li tvarja minn sedazzjoni sa koma.
English: Carcinogenicity
Maltese: Tromboemboliżmu
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 kkurati b'olanzapine, meta mqabblin ma' pazjenti kkurati bil-plaċebo (1.3% kontra 0.4%, rispettivament).
English: Olanzapine demonstrated a greater in vitro affinity for serotonin 5 HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo models.
Maltese: dopamine D2 u attività in vivo akbar għal 5-HT2 milli għal D2.
English: PHARMACEUTICAL FORM AND CONTENTS 28 orodispersible tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 28 pillola miksija b'rita
English: Olanzapine Apotex 5 mg orodispersible tablets Olanzapine Apotex 10 mg orodispersible tablets Olanzapine Apotex 15 mg orodispersible tablets Olanzapine Apotex 20 mg orodispersible tablets
Maltese: Olanzapine Apotex 5 mg pilloli li jinħallu fil-ħalq Olanzapine Apotex 10 mg pilloli li jinħallu fil-ħalq Olanzapine Apotex 15 mg pilloli li jinħallu fil-ħalq Olanzapine Apotex 20 mg pilloli li jinħallu fil-ħalq
English: tachycardia/fibrillation, sudden death (see section 4.4)11
Maltese: Takikardija/ fibrillazzjoni ventrikulari, mewt għall-għarrieda (ara sezzjoni 4.4)11
English: • Parkinson's disease
Maltese: • Marda ta' Parkinson
English: • Olanzapine Apotex 7.5 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘7.5' on the other side.
Maltese: • Olanzapine Apotex 7.5 mg pilloli miksija b'rita huma bojod, tondi, bikonvessi, imnaqqxa b'‘APO' fuq naħa waħda u ‘OLA' fuq ‘7.5' fuq in-naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 7.5 mg film-coated tablets olanzapine STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 7.5 mg ta' olanzapine.
English: General CNS activity
Maltese: Attività tas-Sistema Nervuża Ċentrali (CNS)
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: 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' 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: Tablet coat
Maltese: pillola.
English: Excipient with known effect: Each film-coated tablet contains 189.50 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 189.50 mg ta' lactose.
English: Excipient with known effect: Each film-coated tablet contains 252.70 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 252.70 mg ta' lactose.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 2.5mg olanzapine.
English: How to store Olanzapine Apotex
Maltese: Tieħux Olanzapine Apotex
English: 11 Adverse event identified from spontaneous post-marketing reporting with frequency determined utilising the Olanzapine Integrated Database.
Maltese: 11 Avveniment avvers identifikat minn rappurtaġġ spontanju wara li l-prodott tqiegħed fis-suq bil frekwenza ddeterminata bl-użu tad-Database Integrat ta' Olanzapine.
English: Glucosuria Increased appetite
Maltese: Glikosurja Żieda fl-aptit
English: Other medicines and Olanzapine Apotex
Maltese: Mediċini oħra u Olanzapine Apotex
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: In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Maltese: Fi studji kliniċi, id-deterjorament fis-sintomi tal-marda ta' Parkinson u alluċinazzjonijiet kienu rrappurtati b'mod komuni ħafna u aktar ta' spiss milli bilplaċebo (ara sezzjoni 4.8), u olanzapine ma kienx aktar effettiv mill-plaċebo fil-kura tas-sintomi psikotiċi.
English: Tardive Dyskinesia
Maltese: Diskinesija Tardiva
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Apotex.
Maltese: • Livell għoli ta' zokkor fid-demm u livelli għolja ta' xaħmijiet (trigliċeridi u kolesterol) instabu f'pazjenti li qed jieħdu Olanzapine Apotex.
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 persuna 1 minn kull 10 persuni) jinkludu tibdil fillivelli ta' xi ċelluli tad-demm ta' xaħmijiet fiċ-ċirkolazzjoni u kmieni fil-kura, żidiet temporanji talenzimi tal-fwied; żidiet fil-livelli ta' zokkor fid-demm u fl-awrina; żidiet fil-livelli tal-aċidu uriku u talcreatine 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 talilma 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: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.016 mmol/l) li żdiedu għal għoljin
English: Only slight to moderate increase in olanzapine clearance has been observed.
Maltese: Ġiet osservata żieda żgħira sa moderata fil-clearance ta' olanzapine mill-ġisem.
English: INFORMATION IN BRAILLE Olanzapine Apotex 7.5 mg film-coated tablet
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine Apotex 7.5 mg pillola miksija b'rita
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39 - < 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common.
Maltese: Tibdil fil-livelli tal-kolesterol totali waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 4.39 - < 5.17 mmol/l) għal għoljin (≥ 5.17 mmol/l) kienu komuni ħafna.
English: • Each Olanzapine Apotex 20 mg orodispersible tablet contains 20 mg olanzapine.
Maltese: • Kull Olanzapine Apotex 20 mg pillola li tinħall fil-ħalq fiha 20 mg ta' olanzapine.
English: In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Maltese: Fi studji kliniċi, il-medja ta' espożizzjoni għal olanzapine kienet bejn wieħed u ieħor ta' 27% ogħla fl-adolexxenti.
English: 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: 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: • Periodic Safety update Reports
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: Urinary hesitation11
Maltese: Eżitazzjoni urinarja11
English: 6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Maltese: P6 PFi studji kliniċi, l-inċidenza tal-marda ta' Parkinson u distonja f'pazjenti kkurati b'olanzapine kienet numerikament ogħla, imma statistikament mhux differenti b'mod sinifikattiv mill-plaċebo.
English: Aluminium/aluminium blister strips in cartons of 28, 56 and 98 film-coated tablets per carton.
Maltese: Strixxi bil-folji tal-aluminju/aluminju f'kaxxi tal-kartun ta' 28, 56 u 98 pillola miksija b'rita f'kull kaxxa tal-kartun.
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17< 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.
Maltese: Tibdil fil-livelli tal-kolesterol totali waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 5.17 - < 6.2 mmol/l) għal għoljin (≥ 6.2 mmol/l) kienu komuni ħafna.
English: Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12 mg dose).
Maltese: Newtropenja, tromboċitopenja jew l-anemija riversibbli żviluppaw fi ftit klieb ikkurati bi 8 jew 10 mg/kg/kuljum (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: The metabolism of olanzapine may be induced by smoking.
Maltese: Il-metaboliżmu ta' olanzapine jista' jiżdied bit-tipjip.
English: In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson's disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Maltese: Fi studji kliniċi f'pazjenti b'psikożi dovuta għall-mediċina (agonist ta' dopamine) assoċjata mal-marda ta' Parkinson, id-deterjorament fis-sintomi tal-marda ta' Parkinson u fl-alluċinazzjonijiet, kienu rrappurtati b'mod komuni ħafna u aktar ta' spiss milli bil-plaċebo.
English: Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Maltese: Olanzapine wera wkoll riżultati effikaċji li jistgħu jiġu kumparati ma' haloperidol fit-termini tal-proporzjon ta' pazjenti f'remissjoni sintomatika minn manija u depressjoni F'6 u 12-il ġimgħa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg ta' olanzapine.
English: • Olanzapine Apotex 2.5 mg are white, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side.
Maltese: • Olanzapine Apotex 2.5 mg pilloli miksija b'rita huma bojod, tondi, bikonvessi, imnaqqxa b'‘APO' fuq naħa waħda u ‘OLA' fuq ‘2.5' fuq in-naħa l-oħra.
English: • Each Olanzapine Apotex 7.5 mg film-coated tablet contains 7.5 mg olanzapine.
Maltese: • Kull Olanzapine Apotex pillola miksija b'rita 7.5 mg fiha 7.5 mg ta' olanzapine.
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: 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 Apotex 5 mg and 10 mg orodispersible tablets are available in blisters packs of 28 , 56
Maltese: • Olanzapine Apotex 5 mg u 10 mg pilloli miksija b'rita huma disponibbli f'pakketti bil-folji ta' 28,
English: Amnesia Dysarthria Stuttering11
Maltese: Sonnolenza Sturdament Akatizja6
English: Excipient with known effect: Each film-coated tablet contains 63.17 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 63.17 mg ta' lactose.
English: • Each Olanzapine Apotex 2.5 mg film-coated tablet contains 2.5 mg olanzapine.
Maltese: • Kull Olanzapine Apotex pillola miksija b'rita 2.5 mg fiha 2.5 mg ta' olanzapine.
English: The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
Maltese: L-għoti fl-istess ħin tal-faħam attivat wera li jnaqqas il-bijodisponibilità orali ta' olanzapine b'50% sa 60%.
English: In female versus male subjects, the mean elimination half-life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/hr).
Maltese: 32.3 sigħat) u t-tneħħija tnaqqset (18.9 kontra 27.3 l/siegħa).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/004-005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/635/004-005
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 kura b'olanzapine flimkien ma' lithium jew divalproex, żieda ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem seħħet fi 17.4% tal-pazjenti waqt il-kura akuta (sa 6 ġimgħat).
English: Absolute oral bioavailability relative to intravenous administration has not been determined.
Maltese: Il-bijodisponibilità' assoluta orali relattiva għal amministrazzjoni fil-vina ma' kienitx determinata.
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: 8 Fi 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: • Olanzapine Apotex 10 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘10' on the other side.
Maltese: • Olanzapine Apotex 10 mg pilloli miksija b'rita huma bojod, tondi, bikonvessi, imnaqqxa b'‘APO' fuq naħa waħda u ‘OLA' fuq ‘10' fuq in-naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg orodispersible tablets olanzapine
Maltese: Olanzapine Apotex 5 mg pilloli miksija b'rita olanzapine
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets 56 film-coated tablets 98 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use Read the package leaflet before use.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Strixxi bil-folji tal-aluminju/aluminju f'kaxxi tal-kartun ta' 28 u 56 pillola li jinħallu fil-ħalq f'kull kaxxa tal-kartun.
English: Dyskinesia
Maltese: Tqala
English: • Olanzapine Apotex 2.5 mg film-coated tablets are available in blisters packs of 28 tablets.
Maltese: • Olanzapine Apotex 2.5 mg pilloli miksija b'rita huma disponibbli f'pakketti bil-folji ta' 28 pillola.
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female nonsmokers and 77 % in male smokers.
Maltese: Iż-żieda medja f'olanzapine Cmax wara t-teħid ta' fluvoxamine kienet 54% fin-nisa li ma jpejpux u 77% fl-irġiel li jpejpu.
English: • Olanzapine Apotex 20 mg orodispersible tablets are available in blister packs of 28 and 56 tablets.
Maltese: • Olanzapine Apotex 20 mg pilloli li jinħallu fil-ħalq huma disponibbli f'pakketti bil-folji ta' 28 u 56 pillola.
English: In the study, the risk of olanzapine was comparable to the risk of atypical antipsychotics included in a pooled analysis.
Maltese: Fl-istudju, ir-riskju ta' olanzapine kien simili għar-riskju minn antipsikotiċi atipiċi li kienu inklużi f'analiżi ta' numru ta' studji.
English: • Olanzapine Apotex 5 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘5' on the other side.
Maltese: • Olanzapine Apotex 5 mg pilloli miksija b'rita huma bojod, tondi, bikonvessi, imnaqqxa b'‘APO' fuq naħa waħda u ‘OLA' fuq ‘5' fuq in-naħa l-oħra.
English: Pregnancy, puerperium and perinatal conditions
Maltese: Disturbi fis-sistema riproduttiva u fis-sider
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/013-014
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/635/013-014
English: Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Maltese: Studji elettrofiżjoloġiċi wrew illi olanzapine b'mod selettiv naqqas l-istimulazzjoni tan-newroni dopaminerġiċi mesolimbiċi (A10), waqt li kellu ftit effett fuq is-sekwenza tar-reazzjoni strijatali (A9) involuta fil-funzjoni tal-muskoli.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets olanzapine
Maltese: Olanzapine Apotex 2.5 mg pilloli miksija b'rita olanzapine
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg orodispersible tablets olanzapine
Maltese: Olanzapine Apotex 10 mg pilloli miksija b'rita olanzapine
English: Sedation affected mating performance of male rats.
Maltese: jkollu effetti sekondarji serji.
English: Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Maltese: Effetti riversibbli konsistenti ma' prolaktin elevat fil-firien inkludew tnaqqis fil-piż ta' l-ovarji u ta' l-utru, u tibdiliet morfoloġiċi flepitilju tal-vaġina u fis-sider.
English: • Each Olanzapine Apotex 10 mg film-coated tablet contains 10 mg olanzapine.
Maltese: • Kull Olanzapine Apotex 10 mg pillola li tinħall fil-ħalq fiha 10 mg ta' olanzapine.
English: • Olanzapine Apotex 5 mg and 10 mg film- coated tablets are available in blister packs of 28, 56
Maltese: • Olanzapine Apotex 5 mg u 10 mg pilloli li jinħallu fil-ħalq huma disponibbli f'pakketti bil-folji ta' 28, 56 u 98 pillola.
English: In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
Maltese: F'pazjenti b'diżordni ta' manija jew diżordni bipolari b'episodju mħallat, olanzapine wera effikaċja superjuri għall-plaċebo u għal valproate semisodium (divaproex) fit-tnaqqis ta' sintomi ta' manija f'aktar minn 3 ġimgħat.
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, kura b'olanzapine kienet assoċjata ma' inċidenza ogħla ta' mwiet u reazzjonijiet avversi ċerebro-vaskulari meta mqabbla mal-plaċebo (ara sezzjoni 4.4).
English: Bradycardia
Maltese: Newtropenja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/008-009 EU/1/10/635/017 BATCH NUMBER
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/635/008-009
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: Kura b'olanzapine għal żmien twil (sa 12-il xahar) bl-għan ta' prevenzjoni ta' episodju ieħor f'pazjenti b'mard bipolari kienet assoċjata ma' żieda ta' ≥ 7% mil-linja bażi tal-piż tal-ġisem f'39.9% tal-pazjenti.
English: INFORMATION IN BRAILLE Olanzapine Apotex 10 mg orodispersible tablet
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine Apotex 10 mg pillola miksija b'rita
English: In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Maltese: Fi studju ta' terapija ta' pazjenti kkurati flimkien b'lithium jew b'valproate għal minimu ta' ġimgħatejn, iż-żieda ta' olanzapine 10 mg (terapija flimkien ma' lithium jew valproate) wara 6 ġimgħat irriżultat fi tnaqqis akbar tas-sintomi tal-manija milli b'monoterapija b'lithium jew b'valproate.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg film-coated tablets olanzapine STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 10 mg ta' olanzapine.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg film-coated tablets olanzapine STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 5 mg ta' olanzapine.
English: Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Maltese: Sinjali kliniċi inkludew sedazzjoni (użu ta' kalmanti), atassja, rogħda, takikardja, diffikultà fir-respirazzjoni, tidjiq tal-pupilla ta' l-għajn, u anoreksja.
English: Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects.
Maltese: Olanzapine naqqas ir-rispons ta' ħrib kundizzjonat, test indikattiv ta' attività antipsikotika, f'dożi anqas minn dawk li jwasslu għall-katalepsi, konsegwenza indikattiva ta' effett mhux mixtieq fuq ilmuskoli.
English: INFORMATION IN BRAILLE Olanzapine Apotex 5 mg orodispersible tablet
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine Apotex 5 mg pillola miksija b'rita
English: • Olanzapine Apotex 20 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘20' on the other side.
Maltese: • Olanzapine Apotex 20 mg pilloli li jinħallu fil-ħalq huma sofor, tondi, ċatti, b'tarf radjali, imnaqqxa b''APO' fuq naħa waħda u ‘OL' fuq ‘20' fuq in-naħa l-oħra.
English: • Each Olanzapine Apotex 15 mg orodispersible tablet contains 15 mg olanzapine.
Maltese: • Kull Olanzapine Apotex 15 mg pillola li tinħall fil-ħalq fiha 15 mg ta' olanzapine.
English: Seizures where in most cases a history of seizures or risk factors for seizures were reported 11
Maltese: Aċċessjonijiet li filmaġġoranza tagħhom kien rrappurtat passat mediku ta' aċċessjonijiet jew fatturi tar-riskju għallaċċessjonijiet11
English: Dysarthria
Maltese: • Dijabete
English: Stuttering11
Maltese: Pankreatite11
English: Elevated glucose levels
Maltese: GĦAMLA KWALITATTIVA
English: Removal of the intact orodispersible tablet from the mouth is difficult.
Maltese: Disturb fid-diskors kien ukoll spiss irrappurtat.
English: Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Maltese: Ġew irrappurtati każijiet fatali b'dożi akuti u eċċessivi baxxi daqs 450 mg iżda kien hemm ukoll każ fejn pazjent baqa ħaj wara doża eċċessiva akuta ta' madwar 2 g ta' olanzapine meħud b'mod orali.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna.