FrancophonIA/ELRC3.0 huggingface dataset:
English: Portugal Mylan, Lda.
Maltese: Mylan, Lda.
English: Anticholinergic activity
Maltese: Attività antikolinerġika
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code: N05AH03.
Maltese: Kategorija farmakoterapewtika: psikolettiċi, diazepines, oxazepines, thiazepins u oxepines, kodiċi ATC N05A H03.
English: Signs and symptoms
Maltese: Sinjali u sintomi
English: Olanzapine had no teratogenic effects.
Maltese: Olanzapine ma kellha ebda effetti teratoġeniċi.
English: Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e.g. 1A2, 2D6, 2C9, 2C19, 3A4).
Maltese: Olanzapine ma jinibixxix l-iżoenzimi CYP450 prinċipali in vitro (eż 1A2, 2D6, 2C19, 3A4).
English: 117 Allée des Parcs 69800 Saint-Priest France.
Maltese: 117 Allée des Parcs, 69800
English: Adolescents (ages 13 to 17 years): The pharmacokinetics of olanzapine are similar between adolescents and adults.
Maltese: Adolexxenti (minn 13 sa 17-il sena): Il-farmakokinetika ta' olanzapine fl-adolexxenti u fl-adulti hija simili.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS}
English: • Prostate problems
Maltese: • Problemi tal-prostata
English: Induction of CYP1A2
Maltese: Attivazzjoni ta' CYP1A2
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Maltese: Komuni ħafna: Sedazzjoni (inklużi: ipersomnja, letarġija, sedazzjoni, sonnolenza).
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Maltese: Madankollu, olanzapine (5-20 mg) wera profil ta' sigurtà kumparabbli f'pazjenti nisa (n=467) u f'pazjenti rġiel (n=869).
English: Tolerance developed to the CNS depression.
Maltese: Żviluppat it-tolleranza għad-depressjoni CNS.
English: Elevated triglyceride levels2,5
Maltese: Livelli għolja ta' trigliċeridi2,5
English: The mean increase in olanzapine AUC was 52 % and 108 % respectively.
Maltese: Iż-żjieda medja fl-AUC ta' olanzapine kienet 52% u 108% rispettivament.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 7 ta' Ottubru 2008
English: 6.2 Incompatibilities Not applicable.
Maltese: .2 Inkompatibbilitajiet
English: Increased alkaline phosphatase10
Maltese: Żieda f'alkaline phosphatase10
English: Musculoskeletal and connective tissue disorders Arthralgia9
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Artralġja9
English: General CNS activity
Maltese: Attività tas-CNS ġenerali
English: Priapism12
Maltese: Prijapiżmu12
English: Increased total bilirubin
Maltese: Żieda fil-bilirubin totali
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Mylan 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 MYLAN.
English: Leukopenia10
Maltese: Lewkopenija10
English: Inhibition of CYP1A2
Maltese: Inibizzjoni ta' CYP1A2
English: Acute (single-dose) toxicity
Maltese: Tossiċità akuta (doża waħda)
English: Date of latest renewal: 22 May 2013
Maltese: Data tal-aħħar tiġdid: 22 ta' Mejju, 2013
English: Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Soya lecithin (E322) Xanthan gum (E415)
Maltese: Rita tal-pillola -Alkol polivinil Diossidu tat-titanju E171 Terra E553b Leċitin tas-soja E322 Gomma Xantan E415
English: Discontinuation symptoms7, 12
Maltese: Sintomi ta' twaqqif tal-kura7,12
English: Neuroleptic Malignant Syndrome (NMS)
Maltese: Is-Sindromu Newrolettiku Malinn (NMS)
English: High Gamma Glutamyltransferase10
Maltese: Glutamyltransferase għoli10
English: Dystonia (including oculogyration)11
Maltese: Distonja (tinkludi okuloġirazzjoni)11
English: Marketing Authorisation Holder Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Mylan S.A.S., 117 Allée des Parcs, 69800
English: Generics [UK] Limited Station Close Potters Bar
Maltese: Generics [UK] Limited
English: Haematologic toxicity
Maltese: Tossiċità ematoloġika
English: High Uric Acid10
Maltese: Uric Acid għoli10
English: Hypersensitivity11
Maltese: Sensittività eċċessiva11
English: 12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95 % confidence interval utilising the Olanzapine Integrated Database.
Maltese: 12 Avveniment avvers identifikat minn rappurtaġġ spontanju wara t-tqegħid fis-suq bi frekwenza stmata fil-limitu ta' fuq tal-intervall ta' kunfidenza ta' 95% bl-użu tad-Database Integrata ta' Olanzapine.
English: Common: Elevated cholesterol levels15
Maltese: Komuni: Livelli għolja ta' kolesterol15
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 Mylan 2.5 mg film-coated tablets Olanzapine Mylan 5 mg film-coated tablets Olanzapine Mylan 7.5 mg film-coated tablets Olanzapine Mylan 10 mg film-coated tablets Olanzapine Mylan 15 mg film-coated tablets Olanzapine Mylan 20 mg film-coated tablets
Maltese: OLANZAPINE MYLAN 2.5 mg, pilloli miksija OLANZAPINE MYLAN 5 mg, pilloli miksija OLANZAPINE MYLAN 7.5 mg, pilloli miksija OLANZAPINE MYLAN 10 mg, pilloli miksija OLANZAPINE MYLAN 15 mg, pilloli miksija OLANZAPINE MYLAN 20 mg, pilloli miksija Olanzapine
English: NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Maltese: NMS tista' tkun kundizzjoni potenzjalment fatali assoċjata ma' prodotti mediċinali antipsikotiċi.
English: - The other ingredients are: (tablet core) lactose monohydrate (see section 2 ‘Olanzapine contains lactose'), maize starch, preglatinised maize starch, crospovidone type A, magnesium stearate and (tablet coating) polyvinyl alcohol, titanium dioxide (E171), talc (E553b), soya lecithin (E322) (see section 2 ‘Olanzapine Mylan contains soya lecithin'), xanthan gum (E415).
Maltese: • L-ingredjenti l-oħra huma (qalba tal-pillola) monoidrat tal-lattożju (ara sezzjoni 2 'Olanzapine fih il-lactose'), lamtu talqamħirrum, lamtu tal-qamħirrum preġelatinizzat, crospovidone tip A, stjerejt tal-manjeżju u (qoxra tal-pillola) alkol polivinil, diossidu tat-titanju (E171), terra (E553b), leċitin (soja) (E322) (ara sezzjoni 2 'Olanzapine fih soya lecithin'), gomma xantan (E415).
English: Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4).
Maltese: Komuni ħafna: Żieda ta' aminotransferases tal-fwied (ALT/AST; ara sezzjoni 4.4).
English: Hypothermia12
Maltese: Ipotermija12
English: Respiratory, thoracic and mediastinal disorders Epistaxis9
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Epistassi9
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors.
Maltese: Fi studji ta' qabel l-użu kliniku, olanzapine wera firxa ta' affinitajiet għar-riċetturi (Ki <100 nM) serotoniċi 5-HT2A/2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5: riċetturi muskariniċi kolinerġiċi M1M5; B1B-adrenerġiċi; u riċetturi ta' l-istamina H1.
English: 9 Adverse event identified from clinical trials in the Olanzapine Integrated Database.
Maltese: 9 Avveniment avvers identifikat minn provi kliniċi fid-Database Integrata ta' Olanzapine.
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16.
Maltese: Tnaqqis fil-bilirubin totali, żieda ta' GGT, livelli elevati ta' prolactin fil-plażma16.
English: Also contains lactose monohydrate and soya lecithin.
Maltese: TA' EĊĊIPJENTI Fih ukoll lactose monohydrate u soya lecithin.
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 tat-aminotransferases tal-fwied li ma jurux sintomi u li huma momentanji (ara sezzjoni 4.4), raxx, astenja, għeja, deni, artralġja, żieda fil-livell ta' alkaline phosphatase, livelli għoljin ta' gamma glutamyltransferase għolja, uric acid, creatine phosphokinase u edima.
English: Olanzapine Mylan contains the active substance olanzapine.
Maltese: Olanzapine Mylan fih is-sustanza attiva olanzapine.
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: Olanzapine is indicated for the treatment of moderate to severe manic episode.
Maltese: Olanzapine hija indikata għat-trattament ta' episodju ta' manija moderat jew serju.
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: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindromu ta' rtirar mill-mediċina neonatali (ara sezzjoni 4.6)
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (≥ 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: Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.016 mmol/l) li żdiedu għal għoljin (≥ 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: Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg is available in packs containing 10, 28, 30, 35, 56, 70 (2 x 35 multipack) and 70 film-coated tablets.
Maltese: L-Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 15 mg u 20 mg huwa disponibbli f'pakketti li fihom 10, 28, 30, 35, 56, 70 (2 × 35) u 70 pillola miksija b'rita.
English: Cold-formed aluminium/aluminium perforated unit dose blisters in cartons of 28 x 1, 56 x 1 (7.5 mg only), 98 x 1 (5 mg, 7.5 mg and 10 mg only) and 100 x 1 (7.5 mg only) film-coated tablets.
Maltese: Folji ta' doża waħda maħduma bierda ta' aluminju/aluminju f'kaxex ta' 28 × 1, 56 × 1 (7.5 mg biss), 98 × 1 (5 mg, 7.5 mg u 10 mg biss) u 100 × 1 (7.5 mg biss) pillola miksija b'rita.
English: • Stroke or “mini” stroke (temporary symptoms of stroke)
Maltese: • Puplesija jew puplesija “ħafifa” (sintomi temporanji ta' puplesija)
English: Renal and/or hepatic impairment
Maltese: Indeboliment renali u/jew epatiku
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: 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: Bradycardia QTc prolongation (see section 4.4)
Maltese: Bradikardija QTc imtawwal (ara sezzjoni 4.4)
English: 16 Elevated plasma prolactin levels were reported in 47.4 % of adolescent patients.
Maltese: 16 F'47.4% tal-pazjenti adolexxenti ġew irrapportati livelli għoljin ta' prolactin fil-plażma.
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Maltese: Olanzapine hija fil-biċċa 'l kbira marbuta mal-albumina u B1B-aċidglycoprotein.
English: There were more smokers among subjects with cirrhosis (4/6; 67 %) than among subjects with no hepatic dysfunction (0/3; 0 %).
Maltese: Kien hemm aktar nies li jpejpu fost is-suġġetti b'ċirrożi (4/6; 67 %) milli fost is-suġġetti li ma kellhom ebda disfunzjoni epatika (0/3; 0 %).
English: The predominant pharmacologic activity is from the parent olanzapine.
Maltese: L-attività farmakoloġika predominanti ġejja minn olanzapine nnifsu.
English: Ventricular tachycardia/fibrillation , sudden death (see section 4.4)11
Maltese: Takikardija/ fibrillazzjoni ventrikulari, mewt għall-għarrieda (ara sezzjoni 4.4)11
English: QT interval
Maltese: L-Intervall QT
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: B'espożizzjoni għal perijodu twil ta' żmien (għallinqas 24 ġimgħa) 89.4 % żiedu ≥ 7 %, 55.3 % żiedu ≥ 15 % u 29.1 % żiedu ≥ 25 % mil-linja bażi tal-piż tal-ġisem tagħhom.
English: Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Maltese: Fluvoxamine, inibitur speċifiku ta'CYP1A2, deher li jinibixxi sinifikatament il-metaboliżmu ta' olanzapine.
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Maltese: Sinjali oħra jistgħu jinkludu creatine phosphokinase elevat, mijoglobina fl-awrina (rabdomajoliżi) u insuffiċjenza akuta renali.
English: Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section
Maltese: Tromboemboliżmu (inkluż l-emboliżmu pulmonari u t-trombożi tal-vini fil-fond) (ara sezzjoni 4.4)
English: Each Olanzapine Mylan tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of the active substance.
Maltese: Kull pillola ta' l-Olanzapine Mylan fiha jew 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg jew 20 mg tas-sustanza attiva.
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 t-tqegħid fis-suq bi frekwenza determinata bl-użu tad-Database Integrata ta' Olanzapine.
English: While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Maltese: Waqt li olanzapine wera attività antikolinerġika in vitro, ersperjenza waqt il-provi kliniċi uriet inċidenza baxxa ta' ġrajjiet relatati.
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Maltese: Reazzjoni għallMediċina b'Esinofilja u Sintomi Sistemiċi (DRESS)
English: Elevated glucose levels4
Maltese: Livelli għolja ta' glucose4
English: In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/hr).
Maltese: F' pazjenti femminili f'paragun ma' dawk maskili il-medja tal-half life ta' l-eliminazzjoni ġiet kemmxejn mtawla (36.7 kontra 32.3 sigħat) u t-tneħħija tnaqqset (18.9 kontra 27.3 l/hr).
English: Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Maltese: In-newtropenja kienet rappurtata spiss meta olanzapine u l-valproate intużaw flimkien (ara Sezzjoni 4.8).
English: Nervous system disorders Somnolence Dizziness Akathisia6
Maltese: Disturbi fis-sistema nervuża Sonnolenza Sturdament Akatizja6
English: Olanzapine Mylan with alcohol
Maltese: OLANZAPINE MYLAN mal-alkoħol
English: High creatine phosphokinase11
Maltese: Creatine phosphokinase għoli11 Gamma
English: Investigations Elevated plasma prolactin levels8
Maltese: Investigazzjonijiet Livelli elevati ta' prolactin fil-plażma 8
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: Olanzapine wera affinità akbar in vitro għal serotonin 5-HT2 milli għarriċetturi ta' dopamine D2 u attività in vivo akbar għal 5-HT2 milli għal D2.
English: In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1 %; a potential contributing factor could be high plasma valproate levels.
Maltese: Fi studju kliniku wieħed f'pazjenti b'manija bipolari, terapija b'valproate flimkien ma' olanzapine rriżultat f'inċidenza ta' newtropenja ta' 4.1%; fattur potenzjalment kontributorju jista' jkun livelli għolja ta' valproate fil-plażma.
English: 28 x 1 film-coated tablets 56 x 1 film-coated tablets 98 x 1 film-coated tablets 100 x 1 film-coated tablets
Maltese: 28 × 1 pilloli miksijin b'rita 56 × 1 pilloli miksijin b'rita 98 × 1 pilloli miksijin b'rita 100 × 1 pilloli miksijin b'rita
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) f'paragun ma' pazjenti mhux anzjani, il-half life ta' l-eliminazzjoni medja twalet (51.8 paragun ma' 33.8 siegħa) u t-tneħħija tnaqqset (17.5 paragun ma' 18.2 l/hr).
English: High Density Polyethylene (HDPE) bottle with polypropylene screw cap containing 100 (7.5 mg, 10 mg, 15 mg and 20 mg only), 250 (2.5 mg and 5 mg only) and 500 (2.5 mg, 5 mg and 10 mg only) film-coated tablets.
Maltese: Flixkun ta' high-density polyethylene (HDPE) b'għatu bil-kamini tal-polypropylene fihom 100 (7.5 mg, 10 mg, 15 mg u 20 mg biss), 250 (2.5 mg u 5 mg biss) u 500
English: Cytochromes P450CYP1A2 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: L-enżimi ċitokromju P450-CYP1A2 u P450-CYP2D6 jikkontrbwixxu għall-formazzjoni ta' prodotti metaboliċi tat-tip N-desmethyl u 2-hydroxymethyl.
English: V.J.
Maltese: U L-UŻU.
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 stabilizzatur tal-burdata li turi profil farmakoloġiku ta' firxa wiesa' ta' sistemi ta' riċetturi.
English: Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Maltese: Sinjali ta' tossiċità orali fir-rodenti kienu simili għas-sustanzi newrolettiċi qawwija: attività baxxa, koma, rogħda, konvulżjonijiet kloniċi, salivazzjoni, u tnaqqis fiż-żjieda tal-piż.
English: Olanzapine Mylan 10 mg is available in packs containing 7, 10, 28, 30, 35, 56, 70 (2 x 35) (multipack) and 70 film-coated tablets.
Maltese: Olanzapine Mylan 10 mg jiġi f'pakketti li fihom 7, 10, 28, 30, 35, 56, 70 (2 × 35) u 70 pillola miksija b'rita.
English: Repeated-dose toxicity
Maltese: Tossiċità ta' dożi repetuti
English: Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Maltese: Effetti sekondarji rari ħafna jinkludu reazzjonijiet allerġiċi bħar-Reazzjoni għall-Mediċini b'Esinofilja u Sintomi Sistematiċi (DRESS).
English: Information on long term safety is primarily limited to open-label, uncontrolled data.
Maltese: L-informazzjoni dwar is-sigurtà fit-tul hija primarjament limitata għal dejta open-label li mhijiex ikkontrollata.
English: A mass balance study showed that approximately 57 % of radiolabelled olanzapine appeared in urine, principally as metabolites.
Maltese: Studju ta' tqabbil tal-piżijiet wera bejn wieħed u ieħor 57% ta' olanzapine radjuattiv fl-urina, prinċipalment bħala prodotti metaboliċi.
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 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 2C19).
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: Ub'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: • Seizures
Maltese: • Aċċessjonijiet
English: PC: {number} SN: {number} NN: {number}
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Do not store above 25 °C.
Maltese: Taħżnux f'temperatura 'l fuq minn 25 °C.
English: The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Maltese: Mhux rakkomandat l-użu konkomitanti ta' olanzapine ma' prodotti mediċinali kontra l-Parkinson f'pazjenti bil-marda ta' Parkinson u d-demenzja (ara sezzjoni 4.4).
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: Tel: +33 4 37 25 75 00
Maltese: Mylan S.A.S Tel: +33 4 37 25 75 00