FrancophonIA/ELRC3.0 huggingface dataset:
English: The end date of the 6 month storage period at a temperature up to 25 °C should be recorded on the product carton.
Maltese: Id-data tat-tmiem tal-perjodu ta' ħażna ta' 6 xhur f'temperatura sa 25°C għandha tiġi rrekordjata fuq il-kartuna tal-prodott.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/009 - 30 x (Jivi 2000 IU)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1324/009 - 30 x (Jivi 2000
English: EU/1/18/1324/001 - 1 x (Jivi 250 IU) EU/1/18/1324/002 - 1 x (Jivi 500 IU) EU/1/18/1324/003 - 1 x (Jivi 1000 IU) EU/1/18/1324/004 - 1 x (Jivi 2000 IU) EU/1/18/1324/005 - 1 x (Jivi 3000 IU) EU/1/18/1324/006 - 30 x (Jivi 250 IU) EU/1/18/1324/007 - 30 x (Jivi 500 IU) EU/1/18/1324/008 - 30 x (Jivi 1000 IU) EU/1/18/1324/009 - 30 x (Jivi 2000 IU) EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
Maltese: IU) EU/1/18/1324/005 - 1x (Jivi 3,000 IU) EU/1/18/1324/006 - 30 x (Jivi 250
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TA' BARRA TA' PAKKETT MULTIPLU BI 30 PAKKETT TA' WIEĦED (INKLUŻA
English: shortness of breath, low blood pressure, for early symptoms see above)
Maltese: tħarħir, qtugħ ta' nifs, pressjoni baxxa, għal sintomi bikrija ara hawn fuq)
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar is-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva li jinkludu ħorriqija, urtikarja ġeneralizzata, għafis fis-sider, tħarħar, pressjoni baxxa u anafilassi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
English: • burning and stinging at the application site
Maltese: • ħruq u tingiż fis-sit tal-applikazzjoni
English: KT10 9NW UK
Maltese: KT10 9NW
English: Epistaxis9
Maltese: Epistassi9
English: Date of first authorisation: 14 November 2007 Date of latest renewal: 01 October 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 14 ta' Novembru 2007 Data ta' l-aħħar tiġdid: 01 Ottubru 2012
English: - The active substance is olanzapine.
Maltese: - Is-sustanza attiva hi olanzapine.
English: Indigo carmine aluminium lake (E132) Brilliant blue FCF aluminium lake (E133) Iron oxide black (E172)
Maltese: Indigo carmine aluminium lake (E132) Brilliant blue FCF aluminium lake (E133)
English: Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, UK Tel: +44 (0)1372 461407
Maltese: Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, Renju Unit Tel: +44 (0)1372 461407
English: Opadry Blue containing:
Maltese: Opadry Blue li fih:
English: Pharmacotherapeutic group: diazepines, oxazepines and thiazepines., ATC code: N05A H03.
Maltese: Grupp farmako-terapewtiku:: diazepines, oxazepines u thiazepines, kodiċi ATC N05A H03.
English: Cipla (EU) Ltd
Maltese: TAD-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Cipla (EU) Ltd
English: Store below 30ºC.
Maltese: Aħżen f'temperaturi anqas minn 30ºC.
English: Nervous system disorders Somnolence
Maltese: Disturbi fis-sistema nervuża Sonnolenza
English: Urinary incontinence, urinary retention Urinary hesitation11
Maltese: Inkontinenza urinarja, żamma tal-urina Eżitazzjoni urinarja11
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 ħafna ( > 1/10), komuni ( > 1/100 sa < 1/10), mhux komuni ( > 1/1,000 sa < 1/100), rari ( > 1/10,000 sa < 1/1,000, rari ħafna ( < 1/10,000), mhux magħrufa (ma jistgħux jiġu stmati mill-informazzjoni li hemm disponibbli).
English: OLANZAPINE CIPLA 2.5 mg coated tablets OLANZAPINE CIPLA 5 mg coated tablets OLANZAPINE CIPLA 7.5 mg coated tablets OLANZAPINE CIPLA 10 mg coated tablets OLANZAPINE CIPLA 15 mg coated tablets olanzapine
Maltese: OLANZAPINE CIPLA 2.5 mg pilloli miksija OLANZAPINE CIPLA 5 mg pilloli miksija OLANZAPINE CIPLA 7.5 mg pilloli miksija OLANZAPINE CIPLA 10 mg pilloli miksija OLANZAPINE CIPLA 15 mg pilloli miksija olanzapine
English: Lactose monohydrate, Maize starch Hydroxypropyl cellulose Magnesium stearate
Maltese: Il-qalba tal-pillola Lactose monohydrate, Maize starch Hydroxypropyl cellulose Magnesium stearate
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your OLANZAPINE CIPLA dose.
Maltese: • anti-epilettiku u stabilizzatur tal-burdata), fluvoxamine (anti-dipressant), jew ciprofloxacin
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: Each Olanzapine Cipla coated tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg or 15 mg of the active substance.
Maltese: Kull OLANZAPINE CIPLA pillola miksija fiha jew 2.5 mg, 5 mg, 7.5 mg, 10 mg jew 15 mg tas-sustanza attiva.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out 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: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar issigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla 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: Olanzapine Cipla 2.5 mg, 5 mg, 7.5 mg and 15 mg coated tablets are available in 28 and 56 blister packs.
Maltese: OLANZAPINE CIPLA 2.5 mg, 5 mg, 7.5 mg u 15 mg pilloli miksija huma disponibbli fi 28 u 56 pakkett bil-folji.
English: 7 coated tablets 28 coated tablets 56 coated tablets
Maltese: 7 pillola miksija 28 pillola miksija 56 pillola miksija
English: With long-term exposure (at least 24 weeks), 89.4 % gained ≥ 7 %, 55.3 % gained ≥ 15 % and 29.1 % gained ≥ 25% of their baseline body weight.
Maltese: 89.4 % żiedu ≥ 7 %, 55.3 % żiedu ≥ 15 % u 29.1 % żiedu ≥ 25 % mil-linja bażi tal-piż tal-ġisem tagħhom.
English: Olanzapine Cipla 10 mg coated tablets are available in 7, 28 and 56 blister packs.
Maltese: OLANZAPINE CIPLA 10 mg pilloli miksija huma disponibbli f'7, 28 u 56 pakkett bil-folji.
English: Ventricular tachycardia/fibrillation , sudden death (see section 4.4)11
Maltese: Takikardija/ fibrillazzjoni ventrikulari, mewt għall- għarrieda (ara sezzjoni 4.4)11
English: 28 coated tablets 56 coated tablets
Maltese: 28 pillola miksija 56 pillola miksija
English: Metabolism and nutrition disorders Weight gain1
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Żieda fil-piż1
English: Neuroleptic malignant syndrome (see section Discontinuation symptoms7, 12
Maltese: Sindromu Newrolettiku Malinn (ara sezzjoni Sintomi ta' twaqqif talkura7,12
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 sezzjoni 4.4), glukosurja, żieda fl-aptit, sturdament, akatiżja, parkinsoniżmu, lewkopenija, newtropenija (ara sezzjoni 4.4), diskineżja, pressjoni baxxa mal-waqfien, effetti antikolinerġiċi, żieda fil-livelli tal-aminotransferases tal-fwied li ma jurux sintomi u li huma momentanji (ara sezzjoni 4.4), raxx, astenja, għeja, deni, artralġja, żieda fil-livell tal-alkaline phophatase, livell għoli ta' gamma glutamyltransferase, livell għoli ta' aċtu uriku, livell għoli ta' creatine phosphokinase u edima.
English: 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 mbgħad 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: 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: In 44 patients with schizophrenia  65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Maltese: F'44 pazjenti skiżofreniċi li għandhom > 65 sena, id-dosaġġ minn 5 sa 20 mg/ġurnata ma kienx assoċjat ma' xi profil distint ta' avvenimenti avversi.
English: Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Maltese: Għalhekk, ma hemm ebda reazzjoni partikolari mistennija kif verifikat minn studji in vitro fejn ma nstabet ebda inibizzjoni tal-metaboliżmu tas-sustanzi attivi li ġejjin: anti-dipressant triċikliku (jirrapreżenta l-aktar il-passaġġ permezz ta' CYP2D6), warfarina (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
English: Patients with renal and/or hepatic impairment
Maltese: Pazjenti b'indeboliment renali u/jew epatiku
English: In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/hr, respectively).
Maltese: F'pazjenti li jpejpu u għandhom disfunzjoni tal-fwied ħafifa, il-half life ta' l-eliminazzjoni medja (39.3 siegħa) twalet u t-tneħħija (18.0 l/hr) tnaqqset bħal f'pazjenti b'saħħithom li ma jpejpux (48.8 siegħa u 14.1 l/hr, rispettivament).
English: HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; 1
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; -1 adrenerġiċi; riċetturi histamine H1.
English: Tablet coat
Maltese: Pillola miksija
English: Olanzapine Cipla 7.5 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 7.5' debossed on one side and ‘NEO' on the other.
Maltese: OLANZAPINE CIPLA 7.5 mg pilloli miksija huma bojod, tondi, bikonvessi, miksija b'rita b''OLZ 7.5' imnaqqxa fuq naħa waħda u ‘NEO' fuq in-naħa l-oħra.
English: - The other ingredients are: - Tablet core: lactose monohydrate (See also end of section 2 - important information about some of the ingredients of Olanzapine Cipla), maize starch, hydroxypropyl cellulose, magnesium stearate.
Maltese: Il-qalba tal-pillola: lactose monohydrate (Ara wkoll it-tmien ta' sezzjoni 2 - Tagħrif importanti dwar xi wħud mis-sustanzi ta' OLANZAPINE CIPLA), maize starch, hydroxypropyl cellulose,
English: Opadry II White containing: Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
Maltese: Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
English: Estrous cycles were affected at doses of 1.1 mg/kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/kg (9 times the maximum human dose).
Maltese: Iċ-ċikli estruwi kienu affettwati b'dożi ta' 1.1 mg/kg (3 darbiet id-doża massima filbniedem) u l-parametri tar-riproduzzjoni kienu influwenzati fil-firien mogħtija 3 mg/kg (9 darbiet id-doża massima fil-bniedem).
English: Abdominal distension9 Pancreatitis11
Maltese: Distonja (tinkludi okuloġirazzjoni)11 Diskineżja tardiva11 Amnesija9
English: In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
Maltese: Fi studji kliniċi, żidiet fil-QTc li kienu klinikament sinifikanti (korrezzjoni fil-QT skond Fridericia [QTcF] ≥≥ 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: Neuroleptic malignant syndrome (see section
Maltese: Sindromu Newrolettiku Malinn (ara sezzjoni
English: Excipient with known effect: Each coated tablet contains 80.7 mg lactose monohydrate For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija fiha 80.7 mg lactose monohydrate Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Absolute oral bioavailability relative to intravenous administration has not been determined
Maltese: Il-biodisponibilità' assoluta orali relattiva għal amministrazzjoni fil-vina ma' kienitx determinata.
English: Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
Maltese: Sintomi oħra morbużi ta' doża eċċessiva li huma medicament sinifikanti jinkludu d-delirju, il-konvulżjoni, koma, possibilment Sindromu Newrolettiku Malinn, depressjoni respiratorja, aspirazzjoni fil-passaġġ respiratorju, pressjoni tad-demm għolja jew baxxa, taħbit tal-qalb irregolari (<2% tal-każijiet ta' doża eċċessiva) u arrest kardjopulmonari .
English: OLANZAPINE CIPLA contains lactose.
Maltese: OLANZAPINE CIPLA fih lactose:
English: Rhabdomyolysis
Maltese: Bradikardija
English: In placebo-controlled clinical trials (612 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: Olanzapine Cipla 7.5 mg coated tablets olanzapine
Maltese: Olanzapine Cipla 7.5 mg pilloli miksija olanzapine
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); problems with speech; 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 flgħajnejn); problemi fil-mod kif titkellem; i l-qalb tħabbat bil-mod; sensittività għad-dawl tax-xemx; tinfaraġ; nefħa fl-addome; telf tal-memorja jew tibda tinsa; inkontinenza urinarja; nuqqas ta' kapaċità li tgħaddi l-urina; jaqa' x-xagħar; nuqqas ta' jew tnaqqis fil-mestrwazzjoni u tibdil fis-sider fl-irġiel u fin-nisa bħal produzzjoni mhux normali ta' ħalib mis-sider jew tkabbir mhux normali.
English: How to take OLANZAPINE CIPLA
Maltese: Tieħux OLANZAPINE CIPLA:
English: Olanzapine Cipla 2.5 mg
Maltese: Olanzapine Cipla 2.5 mg pilloli miksija
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 fit-trattament tas-sintomi psikotiċi.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with betaagonist 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: Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 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: 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%, rispettivament).
English: CLINICAL PARTICULARS
Maltese: TPRODOTT MEDIĊINALI
English: Olanzapine Cipla 7.5 mg
Maltese: Olanzapine Cipla 7.5 mg pilloli miksija
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: Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.69 mmol/l) li żdiedu għal għoljin (≥ 2.26 mmol/l).
English: Excipient with known effect: Each coated tablet contains 161.3 mg lactose monohydrate For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija fiha 161.3 mg lactose monohydrate Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Maltese: Disturbi gastro-intestinali Effetti antikolinerġiċi
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 fi ċ-ċirkolazzjoni u kmieni fil-kura, żidiet temporanji tal-enzimi talfwied; 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: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal Aġenzija Ewropea għall-Mediċini : http://www.ema.europa.eu/
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% talpazjenti.
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Maltese: Psikożi relatata mad-demenzja u/jew disturbi fil-komportament Olanzapine mhux approvat għat-trattament tal-psikożi relatata mad-demenzja u/jew disturbi filkomportament, u mhux irrakkomandat għall-użu f'dan il-grupp partikolari ta' pazjenti, dovut għal żieda fil-mortalità u r-riskju ta' inċident ċerebro-vaskulari.
English: Coated tablet Blue, elliptical, convex, coated tablets with ‘NEO' debossed on one side and plain on the other side.
Maltese: Pillola miksija Pilloli blu, ellittiċi, konvessi,miksija, b''NEO' imnaqqxa fuq naħa waħda u xejn fuq in-naħa l-oħra.
English: Olanzapine Cipla 10 mg coated tablets are white, round, biconvex, coated tablets with ‘OLZ 10' debossed on one side and ‘NEO' on the other.
Maltese: OLANZAPINE CIPLA 10 mg pilloli miksija huma bojod, tondi, bikonvessi, miksija b'rita b''OLZ 10' imnaqqxa fuq naħa waħda u ‘NEO' fuq in-naħa l-oħra.
English: Common
Maltese: Komuni:
English: Neutropenia10
Maltese: Pankreatite11
English: Olanzapine Cipla 15 mg
Maltese: Olanzapine Cipla 15 mg pilloli miksija