FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study in 158 children aged 6 to 16 years with symptomatic asthma, the combination of salmeterol/ fluticasone propionate/ is as efficacious as doubling the dose of fluticasone propionate in respect of symptom control and lung function.
Maltese: Fi studju fuq 158 tifel u tifla ta' età minn 6 snin sa 16-il sena b'ażżma sintomatika, il-kombinazzjoni ta' salmeterol/ fluticasone propionate hija effikaċi daqs doża rduppjata ta' fluticasone propionate rigward ilkontroll tas-sintomi u l-funzjoni tal-pulmun.
English: Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor.
Maltese: Salmeterol huwa agonist selettiv li jaħdem fit-tul (12-il siegħa) tar-riċetturi β2 adrenerġiċi b'katina tal-ġenb twila li teħel ma' exo-sit tar-riċettur.
English: The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Airexar Spiromax.
Maltese: L-istudji deskritti hawn taħt (GOAL, TORCH u SMART) twettqu bl-istess kombinazzjoni ta' doża fissa, salmeterol xinafoate u fluticasone propionate, iżda studjaw prodott awtorizzat qabel; l-istudji deskritti ma twettqux b'Airexar Spiromax.
English: Each Airexar Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent yellow
Maltese: Kull inalatur Airexar Spiromax fih 60 inalazzjoni u huwa abjad b'għatu tal- parti li titqiegħed fil-ħalq isfar semi-trasparenti.
English: Airexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:
Maltese: Airexar Spiromax huwa indikat għat-trattament regolari ta' pazjenti b'ażżma severa fejn l-użu ta' prodott ikkombinat (kortikosterojd li jittieħed man-nifs u agonist tar-riċetturi β2 li jaħdem fit-tul) huwa xieraq:
English: If you are using Airexar Spiromax for asthma, your doctor will want to check your symptoms regularly.
Maltese: Il-frekwenzi ġew derivati minn data minn provi kliniċi.
English: Symptomatic candidiasis of the mouth and throat can be treated with topical anti-fungal therapy whilst still continuing with Airexar Spiromax.
Maltese: Kandidjasi sintomatika tal-ħalq u l-gerżuma tista' tiġi ttrattata b'terapija topika kontra l-fungi waqt li jitkompla Airexar Spiromax.
English: Airexar Spiromax should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway.
Maltese: Airexar Spiromax għandu jingħata b'kawtela f'pazjenti b'tuberkulosi pulmonari attiva jew passiva u infezzjonijiet fungali, virali jew infezzjonijiet oħra tal-passaġġ tan-nifs.
English: Airexar Spiromax 50 micrograms/500 micrograms inhalation powder
Maltese: Airexar Spiromax 50 mikrogrammi/500 mikrogrammi trab li jittieħed man-nifs
English: If Airexar Spiromax therapy has to be withdrawn due to overdose of the β agonist component of the medicinal product, provision of appropriate replacement steroid therapy should be considered.
Maltese: Jekk it-terapija b'Airexar Spiromax ikollha tiġi mwaqqfa minħabba doża eċċessiva tal-komponent agonist tar-riċetturi β tal-prodott mediċinali, għandha tiġi kkunsidrata proviżjoni ta' terapija xierqa ta' sostituzzjoni ta' sterojdi.
English: Airexar Spiromax should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Maltese: Airexar Spiromax għandu jitwaqqaf minnufih, il-pazjent evalwat u jekk ikun meħtieġ għandha tinbeda terapija alternattiva.
English: It is very important that you take your Airexar Spiromax every day as directed.
Maltese: Huwa importanti ħafna li tieħu Airexar Spiromax tiegħek kuljum kif ordnat.
English: Airexar Spiromax contains salmeterol and fluticasone propionate, which have differing modes of action.
Maltese: X'fih Airexar Spiromax - Is-sustanzi attivi huma salmeterol u fluticasone propionate.
English: In patients with asthma or COPD a lesser degree of systemic exposure to inhaled fluticasone propionate has been observed.
Maltese: F'pazjenti bl-ażżma jew b'COPD kien osservat grad inqas ta' esponiment sistemiku għal fluticasone propionate meħud man-nifs.
English: Mogilska 80 Str. 31-546 Kraków, Poland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Maltese: Kraków, Il-Polonja Għal kull tagħrif dwar din il-mediċina, jekk jogħġbok ikkuntattja lir-rappreżentant lokali tad-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq:
English: • Diabetes mellitus (Airexar Spiromax may increase your blood sugar)
Maltese: • Dijabete mellitus (Airexar Spiromax jista' jżid iz-zokkor fid-demm tiegħek)
English: There are no data available from clinical trials on overdose with Airexar Spiromax, however data on overdose with both active substances are given below:
Maltese: M'hemmx data disponibbli minn provi kliniċi dwar doża eċċessiva b'Airexar Spiromax, madankollu data dwar doża eċċessiva biż-żewġ sustanzi attivi hija mogħtija hawn taħt:
English: • Airexar Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time.
Maltese: • Airexar Spiromax jista' jaffettwaw il-produzzjoni normali ta' ormoni sterojdi fil-ġisem, speċjalment jekk ħadt dożi għoljin għal perjodi twal ta' żmien.
English: This can increase your risk of side effects with Airexar Spiromax, including irregular heartbeats, or may make
Maltese: Dan jista' jżid ir-riskju tiegħek li jkollok effetti sekondarji b'Airexar Spiromax, inkluż qalb tħabbat b'mod irregolari, jew jista' jaggrava l-effetti sekondarji.
English: • Do not stop taking Airexar Spiromax or reduce the dose of Airexar Spiromax without talking to your doctor first.
Maltese: • Tiqafx tieħu Airexar Spiromax u tnaqqasx id-doża ta' Airexar Spiromax qabel ma tkellem lit-tabib tiegħek.
English: Airexar Spiromax affecting your adrenal glands.
Maltese: Airexar Spiromax huwa għall-użu f'pazjenti b'ażżma severa biss.
English: (Risk in bold is statistically significant at the 95% level.)
Maltese: Pazjenti Amerikani-Afrikani (Riskju mniżżel b'tipa grassa huwa statistikament sinifikanti fil-livell ta' 95%.)
English: The use of Airexar Spiromax follows three simple steps: open, breathe and close which are outlined below.
Maltese: L-użu ta' Airexar Spiromax isegwi tliet passi sempliċi: iftaħ, ħu n-nifs u għalaq li huma deskritti hawn taħt.
English: • Aching, swollen joints and muscle pain.
Maltese: • Bugħawwieġ fil-muskoli.
English: Allergic reactions to Airexar Spiromax are uncommon (they may affect up to 1 in 100 people).
Maltese: Reazzjonijiet allerġiċi għal Airexar Spiromax jseħħu b'mod mhux komuni (dawn jistgħu jaffettwaw sa persuna waħda minn kull 100).
English: What Airexar Spiromax looks like and contents of the pack Airexar Spiromax is an inhalation powder.
Maltese: Kif jidher Airexar Spiromax u l-kontenut tal-pakkett Airexar Spiromax huwa trab li jittieħed man-nifs.
English: *Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125 mg aluminium)
Maltese: *Konjugat għal proteina carrier CRM197 u adsorbit fuq aluminium phosphate (0.125 mg ta' aluminju).
English: pneumococcal conjugate serotype 6B* 4.4 µg pneumococcal conjugate serotype 9V* 2.2 µg pneumococcal conjugate serotype 18C* 2.2 µg
Maltese: serotip ta' konjugat pnewmokokkali 6B* 4.4 µg serotip ta' konjugat pnewmokokkali 9V* 2.2 µg serotip ta' konjugat pnewmokokkali 14* 2.2 µg serotip ta' konjugat pnewmokokkali 18C* 2.2 µg
English: 1 multidose container (4 doses)
Maltese: 1 kontenitur (4 dożi)
English: Each 0.5 ml dose contains:
Maltese: Kull doża ta' 0.5 ml fiha:
English: 1 pre-filled syringe with separate needle
Maltese: 1 siringa mimlija għal-lest b'labra separata
English: Discontinuation symptoms7, 12
Maltese: Sintomi ta' twaqqif talkura7 ,12
English: Common: Elevated cholesterol levels 15
Maltese: Komuni: Livelli elevate ta' kolesterol 15
English: (See sections 4.5 and 5.2.)
Maltese: (Ara sezzjonijiet 4.5 u 5.2).
English: • Lowering of normal body temperature.
Maltese: • Titbaxxa t-temperatura normali tal-ġisem.
English: • seizures, usually associated with a history of seizures (epilepsy)
Maltese: • Aċċessjonijiet, normalment assoċjati ma' storja ta' aċċessjonijiet (epilessija).
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16
Maltese: Tnaqqis fil-bilirubin totali, żieda ta' GGT, livelli elevati ta' prolactin fil-plażma16
English: Parkinsonism6
Maltese: Parkinsoniżmu Diskineżja6
English: • Carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepresant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Glenmark Europe 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' Olanzapine
English: Urinary incontinence, urinary retention
Maltese: • Inkontinenza urinarja
English: Olanzapine had no teratogenic effects.
Maltese: Olanzapine ma kellha ebda effett teratoġeniku.
English: Olanzapine Glenmark Europe with alcohol
Maltese: Olanzapine Glenmark Europe mal-alkohol
English: • Dizziness.
Maltese: • Irrekwitezza.
English: Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine Glenmark Europe 15 mg orodispersible tablets Olanzapine Glenmark Europe 20 mg orodispersible tablets
Maltese: Olanzapine Glenmark Europe 5 mg pilloli li jinħallu fil-ħalq Olanzapine Glenmark Europe 10 mg pilloli li jinħallu fil-ħalq Olanzapine Glenmark Europe 15 mg pilloli li jinħallu fil-ħalq Olanzapine Glenmark Europe 20 mg pilloli li jinħallu fil-ħalq
English: • Serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Maltese: • Reazzjonijiet allerġiċi bħar-Reazzjoni għall-Mediċini b'Esinofilja u Sintomi Sistematiċi (DRESS).
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: Fi 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' lassoċjati 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: • stuttering,
Maltese: • Sturdament.
English: Olanzapine Glenmark Europe 5 mg, 10 mg, 15 mg and 20 mg are available in aluminium foil blisters of 28, 56, and 70 orodispersible tablets
Maltese: Olanzapine Glenmark Europe 5 mg, 10 mg, 15 mg u 20 mg jiġu f'folji tal-fojl tal-aluminju ta' 28, 56, u 70* pillola li tinħall fil-ħalq
English: Aluminium/aluminium blisters in cartons of 28, 56, 70 tablets per carton.
Maltese: Folji ta' aluminju/aluminju f'kartun ta' 28, 56, 70 pillola għal kull kartuna.
English: Olanzapine Glenmark Europe contains the active substance olanzapine.
Maltese: Olanzapine Glenmark Europe fih is-sustanza attiva olanzapine.
English: Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Maltese: Tromboemboliżm u (inkluż lemboliżmu pulmonari u ttrombożi tal-vini fil-fond) (ara sezzjoni 4.4)
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Maltese: Olanzapine hija fil-biċċa 'l kbira marbuta mal-albumina u 1-aċidglycoprotein.
English: Investigations Elevated plasma prolactin levels8
Maltese: Livelli elevati ta' prolactin filplażma8
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: Olanzapine kien statistikament mhux inferjuri għal-lithium fuq lgħan ewlieni ta' rikorrenza bipolari (olanzapine 30.0%, lithium 38.3%; p = 0.055).
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 sinifikattivament il-metaboliżmu ta' olanzapine.
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' 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: Ventricular tachycardia/fibrillation, sudden death (see section 4.4)11
Maltese: Takikardija/ fibrillazzjoni ventrikulari, mewt għall-għarrieda (ara sezzjoni 4.4)11
English: Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term-exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Maltese: Ilpazjenti li żiedu ≥ 7 %, ≥ 15 % u ≥ 25 % mil-linja bażi tal-piż tal-ġisem tagħhom kienu komuni ħafna (64.4 %, 31.7 % u 12.3 % rispettivament).
English: • Moderate to severe manic episodes,a condition with symptoms of excitement or euphoria
Maltese: • Episodji ta' manija moderati għal severi, kondizzjoni b'sintomi ta' eċitament jew ewforija.
English: • Hypersensitivity (e.g. swelling in the mouth and throat, itching, rash)
Maltese: • Sensittività eċċessiva (eż. nefħa fil-ħalq u l-gerżuma, ħakk, raxx).
English: Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10
Maltese: Tél/Tel: + 46 (0) 40 35 48 10
English: The daily dose of Olanzapine Glenmark Europe is between 5 mg and 20 mg.
Maltese: Id-doża ta' kuljum ta' Olanzapine Glenmark Europe hija bejn 5 mg u 20 mg.
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: Do not use epinephrine, dopamine, or other sympathomimetic agents with beta agonist activity since beta stimulation may worsen hypotension.
Maltese: Tużax epinephrine, dopamine, jew sustanzi oħra simpatomimatiċi b'attività beta-agonista għax listimulazzjoni beta tista' taggrava l-pressjoni baxxa.
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Maltese: Manifestazzjonijiet kliniċi ta' NMS huma deni għoli, ebusija tal-muskoli, stat mentali alterat u evidenza ta' instabbiltà awtonomika (pressjoni tad-demm jew tal-polz irregolari, takikardija, dijaforeżi, u taħbit tal-qalb irregolari).
English: Haematologic toxicity:
Maltese: Tossiċità ematoloġika
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżm u u nnutrizzjoni
English: Tardive Dyskinesia
Maltese: Disturbi vaskulari
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% talkażijiet ta' doża eċċessiva) u arrest kardjopulmonari.
English: phosphokinase11
Maltese: Tromboċitopeenija11
English: • Unusual movements (dyskinesias).
Maltese: • Movimenti mhux tas-soltu (diskajnisjas)
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: F'pazjenti femminili meta mqabbla ma' dawk maskili il-medja tal-half life ta' l-eliminazzjoni ġiet kemmxejn imtawla (36.7 kontra 32.3 sigħat) u t-tneħħija tnaqqset (18.9 kontra 27.3 l/hr).
English: Olanzapine Glenmark Europe orodispersible tablet contains aspartame, which is a source of phenylalanine.
Maltese: Olanzapine Glenmark pillola fiha aspartame, li huwa sors ta' phenylalanine.
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: 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 ivverifikat minn studji in vivo 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 CYP2C19).
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-dożaġġ minn 5 sa 20 mg/ġurnata ma kienx assoċjat ma' xi profil distint ta' avvenimenti avversi.
English: In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/hr).
Maltese: F'pazjenti li ma jpejpux meta mqabbla ma' dawk li jpejpu (irġiel u nisa) il-medja tal-half life ta' leliminazzjoni twalet (38.6 kontra 30.4 siegħa) u l-clearance tnaqqset (18.6 kontra 27.7 l/hr).
English: Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Maltese: Fluoxetine (inibitur CYP2D6), dożi b'waħdiet t'antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il-komportament farmakokinetiku ta' olanzapine.
English: Renal and/or hepatic impairment
Maltese: Pazjenti b'indeboliment renali u/jew epatiku
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr).
Maltese: F'anzjani b'saħħithom (65 u fuqhom) meta mqabbla ma' pazjenti mhux anzjani, il-half life ta' leliminazzjoni medja twalet (51.8 paragun ma' 33.8 siegħa) u t-tneħħija tnaqqset (17.5 meta mqabbel ma' 18.2 l/hr).
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: Musculoskeletal and connective tissue disorders Arthralgia9
Maltese: Disturbi muskoluskeltrali u talconnective tissue
English: 56 orodispersible tablets
Maltese: 15 mg pilloli
English: (≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l< 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Maltese: 1.467 mmol/l) u tibdil fit-trigliċeridi waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 1.016 mmol/l - < 1.467 mmol/l) għal għoljin (≥ 1.467 mmol/l).
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) serotoniċi 5HT2A/2C, 5HT3, 5HT6; dopamine D1,D2, D3, D4, D5: riċetturi muskariniċi kolinerġiċi M1M5; 1-adrenerġiċi; u riċetturi ta' l-istamina H1.
English: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56, 70 tablets per carton.
Maltese: 5mg pilloli Folji ta' aluminju/aluminju f'kartun ta' 28, 56, 70 pillola għal kull kartuna.
English: Respiratory, thoracic and mediastinal disorders Epistaxis9
Maltese: Disturbi respiratorji , toraċiċi u medjastinal i
English: Systemic Symptoms (DRESS)
Maltese: Sistemiċi (DRESS) (ilfrekwenza mhijiex magħrufa)
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] fi kwalunkwe ħin wara l-valur bażiku f'pazjenti b'valur bażiku ta' QTcF < 500 msek) ma kinux komuni (0.1% sa 1%) f'pazjenti kkurati b'olanzapine, b'ebda differenza sinifikanti fl-avvenimenti assoċjati kardijaċi meta mqabbla ma' plaċebo.
English: 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Maltese: - Kull Olanzapine Glenmark Europe pillola li tinħall fil-ħalq fiha 5 mg, 10 mg, 15 mg, 20 mg olanzapine - Is-sustanzi l-oħrajn huma mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
English: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Maltese: Olanzapine hija sustanza antipsikotika, kontra l-manija u stabbilizzatur tal-burdata li turi profil farmakoloġiku ta' firxa wiesa' ta' sistemi ta' riċetturi.