FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of patients who responded with at least the minimum clinically important difference (MCID) of 1 unit TDI focal score at Week 24 was greater for LAVENTAIR ELLIPTA (58%) compared with placebo (41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).
Maltese: ta' punteġġ fokali TDI ta' unità 1 f'Ġimgħa 24 kien akbar għal LAVENTAIR ELLIPTA (58%) meta mqabbel mal-plaċebo (41%) u kull komponent tal-monoterapija (53% għal umeclidinium u 51% għal vilanterol ).
English: From the three active-comparator studies in patients with symptomatic COPD, the risk of a moderate/severe COPD exacerbation compared with tiotropium was reduced by 50% in one study (HR 0.5; 95% CI: 0.3, 1.0; p=0.044).
Maltese: Mit-tliet studji b'sustanza attiva ta' tqabbil f'pazjenti b'COPD sintomatiku, ir-riskju ta' taħrix tas-COPD moderat/sever meta mqabbel ma' tiotropium tnaqqas b'50% fi studju wieħed (HR 0.5; 95% CI: 0.3, 1.0; p=0.044).
English: ELLIPTA 55/22 mcg
Maltese: Tqabbil bejn il-kuri b'LAVENTAIR ELLIPTA 55/22 mcg
English: LAVENTAIR ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: LAVENTAIR ELLIPTA hu indikat bħala kura regolari bi bronkodilatur sabiex jittaffew is-sintomi f'pazjenti adulti b'mard kroniku ostruttiv tal-pulmuni (COPD).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 55 micrograms/22 micrograms
Maltese: TIKKETTA TAL-PAKKETT (BIL-KAXXA L-BLU- PAKKETT MULTIPLU) 55 mikrogramma/22 mikrogramma
English: LAVENTAIR ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in trough FEV1) in several studies.
Maltese: LAVENTAIR ELLIPTA wera titjib fil-funzjoni tal-pulmun (kif definit mill-bidla mil-linja bażi fl-inqas livell tal-FEV1) f'diversi studji.
English: LAVENTAIR ELLIPTA has also shown an improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 24 compared with placebo and each monotherapy component (see Table 1).
Maltese: George's Respiratory Questionnaire (SGRQ) kif indikat minn tnaqqis fil-punteġġ totali tal-SGRQ f'Ġimgħa 24 meta mqabbel mal-plaċebo u kull komponent tal-monoterapija (ara Tabella 1).
English: Use LAVENTAIR ELLIPTA regularly
Maltese: Uża LAVENTAIR ELLIPTA b'mod regolari
English: LAVENTAIR ELLIPTA 55/22 micrograms also showed statistically significant improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 in the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001).
Maltese: LAVENTAIR ELLIPTA 55/22 mikrogramma wera wkoll titjib statistikament sinifikanti meta mqabbel malplaċebo fil-bidla mil-linja bażi fil-kejl tal-volum tal-pulmun fl-inqas livell u 3 sigħat wara d-doża f'Ġimgħa 12 fl-ewwel studju (kapaċità ispiratorja: 237 ml u 316 ml rispettivament, volum residwu: -466 ml u -643 ml rispettivament u kapaċità residwa funzjonali:
English: LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Maltese: meta mqabbel mal-plaċebo u umeclidinium (ara Tabella 1) u wera żieda mil-linja bażi fil-proporzjon ta' ġranet meta ma kienet meħtieġa l-ebda medikazzjoni ta' salvataġġ (medja ta' 11.1%) meta mqabbel ma' tnaqqis mil-linja bażi fuq plaċebo (medja ta' 0.9%).
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms vilanterol (as trifenatate).
Maltese: 55 mikrogramma ta' umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide) u 22 mikrogramma ta' vilanterol (bħala trifenatate).
English: In one 6-month Phase III study, LAVENTAIR ELLIPTA demonstrated statistically significant improvements in trough FEV1 (primary endpoint) at Week 24 compared with placebo and each monotherapy component treatment arm.
Maltese: Fi studju wieħed tal-Fażi 3 ta' 6-xhur, LAVENTAIR ELLIPTA wera titjib statistikament sinifikanti fl-inqas livell tal-FEV1 (endpoint primarju) f'Ġimgħa 24 meta mqabbel ma' plaċebo u kull fergħa ta' kura b'komponent tal-monoterapija.
English: The comparison of FF/UMEC/VI to FF/VI and UMEC/VI resulted in a statistically significant 14.8% reduction in risk of a moderate/severe exacerbation (based on analysis of time to first exacerbation) (Hazard Ratio 0.85; 95% CI: 0.80, 0.91; p<0.001) and 16.0% reduction in risk of a moderate/severe exacerbation respectively (based on analysis of time to first exacerbation) (Hazard Ratio 0.84; 95% CI: 0.78, 0.91; p<0.001).
Maltese: 95% CI: 0.80, 0.91; p<0.001) u tnaqqis ta' 16.0% fir-riskju ta' taħrix moderat/sever rispettivament (abbażi tal-analiżi taż-żmien għall-ewwel taħrix) (Proporzjon ta' Periklu 0.84; 95% CI: 0.78, 0.91; p<0.001).
English: In the other two active-comparator studies, a similar proportion of patients achieved at least the MCID with LAVENTAIR ELLIPTA and tiotropium; 49% and 54% for LAVENTAIR ELLIPTA 55/22 micrograms and 52% and 55% for tiotropium.
Maltese: Fiż-żewġ studji l-oħra bis-sustanza attiva ta' tqabbil, proporzjon simili ta' pazjenti kisbu mill-anqas il-MCID b'LAVENTAIR ELLIPTA u tiotropium; 49% u 54% għal LAVENTAIR ELLIPTA
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not use this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall galactose, nuqqas ta' lactase totali jew malassorbiment tal-glucose-galactose m'għandhomx jużaw dan il prodott mediċinali. 4.5
English: How to use LAVENTAIR ELLIPTA 4.
Maltese: Kif għandek tuża LAVENTAIR ELLIPTA 4.
English: LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol
Maltese: LAVENTAIR ELLIPTA 55 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel umeclidinium/vilanterol
English: In the three 6-month active-comparator-controlled studies, LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol compared with tiotropium, with statistically significant reductions observed in two of the studies (see Table 1).
Maltese: Fit-tliet studji ta' 6 xhur ikkontrollati bis-sustanza attiva ta' tqabbil, LAVENTAIR ELLIPTA naqqas l-użu tal-medikazzjoni ta' salvataġġ b'salbutamol meta mqabbel ma' tiotropium, bi tnaqqis statistikament sinifikanti osservat fi tnejn mill-istudji (ara Tabella 1).
English: In the second study, LAVENTAIR ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗).
Maltese: Fit-tieni studju, LAVENTAIR ELLIPTA 55/22 mikrogramma wera titjib meta mqabbel mal-plaċebo fil-bidla mil linja bażi fil-kejl tal-volum tal-pulmun fl-inqas livell u 3 sigħat wara d-doża f'Ġimgħa 12 (kapaċità ispiratorja: 198 ml u 238 ml rispettivament, volum residwu: -295 ml u -351 ml rispettivament u kapaċità residwa funzjonali:
English: The maximum dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily.
Maltese: Id-doża massima hija inalazzjoni waħda ta' LAVENTAIR ELLIPTA 55/22 mikrogramma darba kuljum.
English: The recommended dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily.
Maltese: Id-doża rakkomandata hija inalazzjoni waħda ta' LAVENTAIR ELLIPTA 55/22 mikrogramma darba kuljum.
English: The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active (moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy volunteers.
Maltese: L-effett ta' umeclidinium/vilanterol fuq l-intervall QT ġie evalwat fi studju tal-QT ikkontrollat bil-plaċebo u bis-sustanza attiva (moxifloxacin) li kien jinvolvi l-għoti darba kuljum ta' dożi lesti minn qabel ta' umeclidinium/vilanterol 113/22 mikrogramma jew 500/100 mikrogramma (doża lesta minn qabel b'umeclidinium f'doża tmien darbiet dik rakkomandata u vilanterol f'doża erba' darbiet dik rakkomandata)
English: The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
Maltese: Il-programm ta' żvilupp kliniku inkluda 2,354 pazjent li rċevew umeclidinium/vilanterol darba kuljum fl-istudji kliniċi tal-Fażi III ta' 24 ġimgħa jew aktar, li minnhom 1,296 pazjent irċevew id-doża rakkomandata ta' 55/22 mikrogramma fi studji ta' 24 ġimgħa,
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).
Maltese: Kull doża mogħtija fiha 55 mikrogramma umeclidinium (ekwivalenti għal 65 mikrogramma ta' umeclidinium bromide) u 22 mikrogramma vilanterol (bħala trifenatate).
English: Following intravenous administration to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Maltese: Vilanterol Wara għoti fil-vini lil voluntiera b'saħħithom, il-volum medju ta' distribuzzjoni fl-istat fiss kien ta' 165 litru.
English: Uncommon side effects (may affect up to 1 in 100 people): • skin rash (hives) or redness
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100): raxx tal-ġilda (ħorriqija) jew ħmura
English: LAVENTAIR ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung volume measures compared with placebo in both studies in adult COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Maltese: LAVENTAIR ELLIPTA 55/22 mikrogramma tejjeb il-ħin tal-felħan għall-eżerċizzju meta mqabbel ma' plaċebo, kif evalwat bl-endurance shuttle walk test (ESWT), fi studju wieħed iżda mhux fit-tieni u tejjeb ilkejl tal-volum tal-pulmun meta mqabbel ma' plaċebo fiż-żewġ studji f'pazjenti adulti b'COPD
English: Other medicines and LAVENTAIR ELLIPTA
Maltese: Mediċini oħra u LAVENTAIR ELLIPTA
English: LAVENTAIR ELLIPTA contains lactose
Maltese: Kif jidher LAVENTAIR ELLIPTA u l-kontenut tal-pakkett
English: There is no relevant use of LAVENTAIR ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Maltese: LAVENTAIR ELLIPTA fil-popolazzjoni pedjatrika (taħt it-18-il sena) m'għandux użu rilevanti għall indikazzjoni ta' COPD.
English: When given subcutaneously there were no effects at 36-times the human clinical exposure of vilanterol 22 micrograms, based on AUC.
Maltese: Meta ngħata taħt il-ġilda, ma kienx hemm effetti b'esponimenti 36 darba aktar mill-esponiment kliniku fil-bniedem ta' vilanterol 22 mikrogramma, fuq il-bażi tal-AUC.
English: • awareness of heart beat (palpitations)
Maltese: • tkun konxju/a tar-rata ta' taħbit tal-qalb (palpitazzjonijiet)
English: Improvements in TDI focal score compared with each monotherapy component and tiotropium were not statistically significant (see Table 1).
Maltese: It-titjib fil-punteġġ fokali TDI meta mqabbel ma' kull komponent talmonoterapija u tiotropium ma kienx statistikament sinifikanti (ara Tabella 1).
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered radioactivity) was excreted in faeces by 192 hours post-dose.
Maltese: Wara għoti fil-vini, madwar 58% taddoża radjutikkettata mogħtija (jew 73% tar-radjuattività rkuprata) tneħħiet fl-ippurgar sa 192 siegħa wara ddoża.
English: TDI Focal Score
Maltese: Ipprepara doża
English: LAVENTAIR ELLIPTA showed a statistically significant reduction in SGRQ total score compared with tiotropium in one of the three activecomparator studies (see Table 1).
Maltese: LAVENTAIR ELLIPTA wera tnaqqis statistikament sinifikanti fil-punteġġ totali tal-SGRQ meta mqabbel ma' tiotropium f'wieħed mit-tliet studji b'sustanza attiva ta' tqabbil (ara Tabella 1).
English: one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month study.
Maltese: 832 pazjent irċevew doża ogħla ta' 113/22 mikrogramma fi studji ta' 24 ġimgħa u 226 pazjent irċevew 113/22 mikrogramma fi studju ta' 12-il xahar.
English: Lung function, symptomatic and health related quality of life outcomes at Week 24 Treatment comparisons with LAVENTAIR
Maltese: Tabella 1.Il-funzjoni tal-pulmun, eżiti sintomatiċi u tal-kwalità tal-ħajja relatata mas-saħħa f'Ġimgħa 24
English: In addition, LAVENTAIR ELLIPTA demonstrated clinically meaningful and statistically significant improvements in trough FEV1 compared with tiotropium in two of the three 6-month active-comparator studies and numerically greater improvements from tiotropium in the third active-comparator study (see Table 1).
Maltese: Barra minn hekk, LAVENTAIR ELLIPTA wera titjib statistikament sinifikanti u klinikament sinifikanti fil-livell minimu tal-FEV1 meta mqabbel ma' tiotropium fi tnejn mit-tliet studji b'sustanza attiva ta' tqabbil ta' 6-xhur u titjib numerikament akbar minn tiotropium fittielet studju b'sustanza attiva ta' tqabbil (ara Tabella 1).
English: Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in CYP2D6 activity (poor metabolisers).
Maltese: Abbażi tal-kobor ta' dawn il-bidliet, ma hija mistennija l-ebda interazzjoni klinikament rilevanti bejn il-mediċini meta umeclidinium/vilanterol jingħata fl-istess ħin ma' inibituri ta' CYP2D6 jew meta jingħata lil pazjenti ġenetikament defiċjenti fl-attività ta' CYP2D6 (metabolizzaturi ħżiena).
English: How to store LAVENTAIR ELLIPTA
Maltese: X'inhu LAVENTAIR ELLIPTA
English: (see sections 4.8 and 5.1).
Maltese: (Ara taqsimiet 4.5 u 5.2)
English: (see section 4.4)11
Maltese: (ara taqsima 4.4)11
English: (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Maltese: (64.4 %, 31.7 % u 12.3 % rispettivament).
English: Olazax 5 mg tablets Olazax 7.5 mg tablets Olazax 10 mg tablets Olazax 15 mg tablets Olazax 20 mg tablets Olanzapine
Maltese: Olazax 5 mg pilloli Olazax 7.5 mg pilloli Olazax 10 mg pilloli Olazax 15 mg pilloli Olazax 20 mg pilloli
English: Store below 30°C.
Maltese: Aħżen f'temperatura ta' inqas minn 30°C.
English: PC: {number} SN: {number} NN: {number}
Maltese: X'għandek tkun taf qabel ma tieħu Olazax
English: Tablet 28 tablets 56 tablets
Maltese: Pillola 28 pillola Pillola 56 pillola
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olazax dose
Maltese: • Carbamazepine (anti-epilettiku u stabilizzatur tal-burdata), fluvoxamine (anti-dipressant), jew ciprofloxacin (antibijotiku), għax jista' jkun hemm bżonn li tbiddel id-doża tiegħek ta' Olazax.
English: Store below 30°C
Maltese: Aħżen f'temperatura ta' inqas minn 30°C
English: 28 tablets
Maltese: Pillola 28 pillola
English: Olazax contains the active substance olanzapine.
Maltese: Olazax fih is-sustanza attiva olanzapine.
English: What Olazax contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Maltese: - Kull Olazax pillola fiha 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg olanzapine - Is-sustanzi l-oħrajn huma mannitol (E 421),microcrystalline cellulose, aspartame (E 951),
English: Information on long term safety is primarily limited to open-label, uncontrolled data.
Maltese: informazzjoni dwar is-sigurtà fit-tul hija primarjament limitata għal dejta open-label li mhijiexikkontrollata.
English: High Gamma
Maltese: Gamma
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 ta 'awtorizzazzjoni fis-suq għandu jissottometti rapporti perjodiċi ta' aġġornament għal dan il-prodott mediċinali jekk il prodott jiġi inkluż fil-lista ta 'dati ta' referenza tal-Unjoni (lista EURD) previsti fl-Artikolu 107c (7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-web-portal.
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; α 1 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: 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: How to store Olazax
Maltese: Tieħux Olazax
English: Date of renewal: 22.08.2014
Maltese: 12.2009 Data tal-aħħar tiġdid: 11.12.2014
English: Olazax 7.5 mg tablets
Maltese: Olazax 7.5 mg pilloli
English: The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to
Maltese: Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10).
English: Olazax with alcohol
Maltese: Olazax mal-alkoħol
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: 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 (< 01/10,000), 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: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56 tablets per carton.
Maltese: Folji ta' aluminju/aluminju f'kartun ta' 28 & 56 pillola għal kull kartuna.
English: Olazax tablet contains aspartame, which is a source of phenylalanine.
Maltese: Olazax pillola fiha aspartame, li huwa sors ta' phenylalanine.
English: PHARMACEUTICAL FORM AND CONTENTS Tablet
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Olazax, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg are available in aluminium foil blisters of 28 or 56 tablets
Maltese: Olazax 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg jiġu f'folji tal-fojl tal-aluminju ta' 28 & 56 pillola Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq Glenmark Pharmaceuticals s.r.o.
English: Tardive
Maltese: TIKKETTAR
English: Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Maltese: Olanzapine jista' jantagonizza l-effetti ta' l-antagonisti ta' dopamine diretti jew indiretti.
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, ilkonvulżjoni, 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: Cytochromes P450-CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
Maltese: enżimi ċitokromju P450-CYP1A2 u P450-CYP2D6 jikkontrbwixxu għall-formazzjoni ta' prodotti metaboliċi tat-tip N-desmethyl u 2-hydroxymethyl.
English: dyskinesia11
Maltese: Rabdomijoliżi11
English: In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500
Maltese: Fi studji kliniċi, żidiet fil-QTc li kienu klinikament sinifikanti (korrezzjoni fil-QT skond Fridericia
English: 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: 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: Olazax 20 mg tablets
Maltese: Olazax 20 mg pilloli
English: The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Maltese: Tossiċità fuq is-sistema riproduttiva Olanzapine ma kellha ebda effetti teratoġeniċi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg olanzapine