FrancophonIA/ELRC3.0 huggingface dataset:
English: It must also not be given to patients who have disorders that cause severe abnormalities of the immune system called ‘severe combined immunodeficiency', who have had intussusception in the past, or who have problems with their bowel that could put them at risk of intussusception.
Maltese: Lanqas ma għandu jingħata lil pazjenti li jkollhom disturbi li jikkawżaw anormalitajiet severi tas-sistema immunitarja msejħa 'immunodefiċjenza kkombinata severa', li kellhom intussuxxezzjoni fil-passat, jew li jkollhom problemi f'imsarinhom li jistgħu jpoġġuhom f'riskju ta' intussuxxezzjoni.
English: Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines.
Maltese: Kondizzjoni serja msejħa intussuxxezzjoni (fejn parti mill-musrana titkebbeb ġo parti oħra tal-musrana, li twassal għal imblokk) ġiet irrappurtata b'mod rari ħafna (dehret f'inqas minn pazjenti wieħed f'10,000) wara l-użu tal-vaċċini tar-rotavirus.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rotarix on 21 February 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rotarix fil-21 ta' Frar 2006.
English: Rotarix contains small amounts of rotavirus, a virus that causes gastroenteritis.
Maltese: Rotarix fih ammonti żgħar tar-rotavirus, li huwa virus li jikkawża l-gastroenterite.
English: The study in premature babies showed that Rotarix was well tolerated and produced similar levels of antibodies as in infants born at full term.
Maltese: L-istudju fi trabi li twieldu qabel iż-żmien wera li Rotarix kien ittollerat tajjeb u pproduċa livelli ta' antikorpi simili għal-livelli fit-trabi li twieldu wara tqala sħiħa.
English: In addition, the company that markets Rotarix is developing a vaccine free of porcine circovirus type 1 (PCV-1) after a very small amount of viral particles was found in the vaccine in 2010.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Rotarix fis-suq qed tiżviluppa vaċċin li ma jkunx fih ċircovirus tal-majjali tat-tip 1 (PCV-1) wara li fl-2010 nstab ammont żgħir ħafna ta' frak virali fil-vaċċin.
English: How has Rotarix been studied?
Maltese: Kif ġie studjat Rotarix?
English: What measures are being taken to ensure the safe and effective use of Rotarix?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Rotarix?
English: When an infant is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘foreign' and makes defences against it. After vaccination, the immune system is able to respond more quickly when it is exposed to the virus again.
Maltese: Wara l-vaċċinazzjoni, is-sistema immunitarja tkun kapaċi tirreaġixxi iżjed malajr f'każ ta' esponiment għall-virus għal darb'oħra.
English: This helps to protect against gastroenteritis caused by rotavirus.
Maltese: Dan jgħin biex jipproteġi kontra l-gastroenterite kkawżata mir-rotavirus.
English: The CHMP decided that Rotarix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Rotarix huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: 14 April 2011
Maltese: 14 ta' April 2011
English: What is Octagam?
Maltese: X'inhu Octagam?
English: • Post-marketing safety studies will be performed.
Maltese: • Sejrin isiru studji ta' wara t-tqegħid fis-suq.
English: Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%)
Maltese: Mistoqsijiet u tweġibiet dwar ir-rakkomandazzjoni li titneħħa s-sospensjoni ta' Octagam (immunoglobulina normali umana 5% u 10%)
English: Octagam is a solution for infusion (drip into a vein) that contains human normal immunoglobulin extracted from blood as the active substance.
Maltese: Octagam huwa soluzzjoni għal infużjoni (dripp fil-vina) li fiha immunoglobulina normali umana estratta mid-demm bħala s-sustanza attiva.
English: The CHMP reviewed investigations that were carried out into the root cause of the problem and proposed corrective measures, including changes to the manufacturing process and tests to be performed during the manufacturing process and on the final products.
Maltese: Is-CHMP irreveda l-investigazzjonijiet li saru fil-kawża bażi tal-problema u ppropona miżuri ta' korrezzjoni, inklużi tibdiliet fil-proċess ta' manifattura u testijiet li għandhom isiru matul il-proċess ta' manifattura u fuq il-prodotti finali.
English: These events were thought to be related to problems with the medicine's manufacture, and included stroke, myocardial infarction (heart attack) and pulmonary embolism (clot in a blood vessel supplying the lungs).
Maltese: problemi fil-manifattura tal-mediċina, u kienu jinkludu puplesija, infart mijokardijaku (attakk tal-qalb) u emboliżmu pulmonari (embolu fil-vina jew l-arterja li jissupplixxu l-pulmuni).
English: The marketing authorisations for Octagam in the EU were suspended by the European Commission, following a review by the CHMP in the September 2010.
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq għal Octagram fl-UE ġew sospiżi mill-Kummissjoni Ewropea wara reviżjoni mis-CHMP f'Settembru 2010.
English: The CHMP concluded that the unexpected presence of factor XIa (an enzyme involved in blood clotting) in Octagam was the main cause of the thromboembolic events.
Maltese: Is-CHMP ikkonkluda li l-preżenza mhux mistennija ta' fattur XIa (enzim involut fl-għaqid tad-demm) f'Octagam, kien il-kawża ewlenija tal-avvenimenti tromboemboliċi.
English: Octagam is used in patients who are at risk of infection because they do not have sufficient antibodies including people with primary immunodeficiency syndrome, or children born with acquired immune deficiency syndrome (AIDS).
Maltese: Octagam jintuża f'pazjenti li huma f'riskju ta' infezzjoni minħabba li ma għandhomx biżżejjed antikorpi inklużi persuni bis-sindromu tal-immunodefiċjenza primarja, jew tfal li jitwieldu bis-sindromu talimmunodefiċjenza akkwiżita (AIDS).
English: Immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.
Maltese: L-imunoglobulini huma antikorpi (tipi ta' proteini) li normalment jinstabu fid-demm li jgħinu lill-ġisem jiġġieled l-infezzjonijiet u mard ieħor.
English: In September 2010, the CHMP, following the suspension of the marketing authorisations of Octagam in Germany and Sweden, recommended that all authorisations for the medicine be suspended across the EU.
Maltese: F'Settembru 2010, wara s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' Octagam filĠermanja u fl-Isvezja, is-CHMP irrakkomanda li l-awtorizzazzjonijiet kollha għall-mediċina jiġu sospiżi madwar l-UE kollha.
English: The aim of the review was to assess all available data on the safety and quality issues related to the thromboembolic events seen with Octagam.
Maltese: L-għan tar-reviżjoni kien li tiġi vvalutata d-dejta kollha disponibbli dwar il-kwistjonijiet ta' sigurtà u kwalità relatati mal-avvenimenti tromboemboliċi li dehru b'Octagam.
English: The Committee also looked at results of batch analyses and independent testing of batches by Member States, as well as information from inspections of two of the manufacturing sites.
Maltese: Il-Kumitat ħares ukoll lejn ir-riżultati ta' analiżiijiet f'lottijiet u ttestjar indipendenti ta' lottijiet minn Stati Membri, kif ukoll informazzjoni minn spezzjonijiet ta' tnejn mis-siti ta' manifattura.
English: Why was Octagam reviewed?
Maltese: Għalxiex ġie rivedut Octagam?
English: The European Medicines Agency has completed a review of Octagam and associated names that was triggered by reports of serious thromboembolic events in patients using the medicine.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Octagam u l-ismijiet assoċjati li saret wara rapporti ta' avvenimenti tromboemboliċi serji f'pazjenti li jużaw il-mediċina.
English: It is also used in people with certain immune disorders such as idiopathic thrombocytopenic purpura and in patients who have had a bone marrow transplant.
Maltese: Jintuża wkoll f'persuni b'ċerti problemi immunoloġiċi bħal purpura tromboċitopenika idjopatika u f'pazjenti li kellhom trapjant tal-mudullun.
English: The background to the suspension was an unexpectedly high number of reports of serious thromboembolic events (problems due to the formation of blood clots in the blood vessels) in patients
Maltese: Ir-raġuni għas-sospensjoni kienet numru għoli mhux mistenni ta' rapporti ta' avvenimenti tromboemboliċi serji (problemi minħabba l-formazzjoni ta' emboli fil-vini u l-arterji) f'pazjenti li kienu qegħdin jużaw il-mediċina.
English: The CHMP also agreed on a test to detect factor XIa or other substances that can cause thromboembolic events before batches are released onto the market.
Maltese: Barra minn hekk, ġew identifikati passi kritiċi fil-proċess ta' manifattura li jistgħu jispjegaw il-preżenza ta' sustanzi li taw bidu għall-avvenimenti tromboemboliċi.
English: Another enzyme, kallikrein, is considered to play a minor role.
Maltese: Enzim ieħor, kallikrein, huwa kkunsidrat li għandu rwol minuri.
English: The marketing authorisation holders will also be required to carry out post-marketing safety studies as soon as the medicine is reintroduced into the market in order to confirm the safety of the improved manufacturing process.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq sejrin ikunu meħtieġa jwettqu studji tas-sigurtà ta' wara t-tqegħid fis-suq hekk kif il-mediċina terġa' tiddaħħal fis-suq sabiex jikkonfermaw is-sigurtà tal-proċess tal-manifattura mtejjeb.
English: Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%) EMA/293780/2011 rev.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fit-23 ta' Mejju 2011.
English: City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
Maltese: City Tower, Hvězdova 1716/2b, 140 78 Praha 4
English: Hertfordshire, WD18 8YA, United Kingdom
Maltese: Hertfordshire, WD18 8YA, Ir-Renju Unit
English: 31, D - 82194 Gröbenzell, Germany
Maltese: 31, D - 82194, Gröbenzell, Il-Ġermanja
English: Date of latest renewal: 19 August 2014
Maltese: Data tal-aħħar tiġdid: 19 Awissu 2014
English: Viso Farmacéutica S.L.U Tél/Tel: + 34 911 593 944
Maltese: L.U Tél/Tel: + 34 911 593 944
English: Olanzapine Glenmark 2.5 mg tablets Olanzapine Glenmark 5 mg tablets Olanzapine Glenmark 7.5 mg tablets Olanzapine Glenmark 10 mg tablets Olanzapine Glenmark 15 mg tablets Olanzapine Glenmark 20 mg tablets
Maltese: Olanzapine Glenmark 2.5 mg pilloli Olanzapine Glenmark 5 mg pilloli Olanzapine Glenmark 7.5 mg pilloli Olanzapine Glenmark 10 mg pilloli Olanzapine Glenmark 15 mg pilloli Olanzapine Glenmark 20 mg pilloli
English: Pharmacotherapeutic group: psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.
Maltese: Kategorija farmakoterapewtika: psikolettiċi, diazepines, oxazepines, thiazepins u oxepines, kodiċi ATC N05A H03.
English: Pancreatitis11
Maltese: Pankreatite11
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, 2C9, 2C19, 3A4).
English: Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Maltese: Komuni ħafna: Sedazzjoni (inklużi: ipersomnja, letarġija, sonnolenza).
English: Date of first authorisation: 03 December 2009 Date of latest renewal: 19 August 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 03 Diċembru 2009 Data tal-aħħar tiġdid: 19 Awissu 2014
English: Store below 30C.
Maltese: Aħżen f'temperatura ta' inqas minn 30C.
English: Common: Elevated cholesterol levels 15
Maltese: Komuni: Livelli għolja ta' kolesterol15
English: Gröbenzell, Germany
Maltese: Gröbenzell, Il-Ġermanja
English: • Carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepresant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Glenmark 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: Contains aspartame.
Maltese: TA' EĊĊIPJENTI Fiha aspartame.
English: 70 tablets
Maltese: 70 pillola
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, pressjoni baxxa mal-waqfien, effetti antikolinerġiċi, żieda fil-livelli tal-aminotransferases tal-fwied li ma jurux sintomi u li huma momentanji (ara taqsima 4.4), raxx, astenja, għeja, deni, artralġja, żieda fillivell tal-alkaline phophatase, livell għoli ta' gamma glutamyltransferase, livell għoli ta' aċtu uriku, livell għoli ta' creatine phosphokinase u edima.
English: Olanzapine is bound predominantly to albumin and α1-acid-glycoprotein.
Maltese: Olanzapine hija fil-biċċa 'l kbira marbuta mal-albumina u 1-aċidglycoprotein.
English: Store below 30C
Maltese: Aħżen f'temperatura ta' inqas minn 30C
English: Elevated cholesterol levels2,3
Maltese: Livelli għolja ta' kolesterol2,3
English: Olanzapine Glenmark tablet contains aspartame, which is a source of phenylalanine.
Maltese: Olanzapine Glenmark pillola fiha aspartame, li huwa sors ta' phenylalanine.
English: Olanzapine Glenmark contains the active substance olanzapine.
Maltese: Olanzapine Glenmark fih is-sustanza attiva olanzapine.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 December 2009
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 03 Diċembru 2009
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: Glenmark Pharmaceuticals B.V. Tél/Tel: + 31 629 62 4818 / +31 40 245 3611
Maltese: Tél/Tel: + 31 629 62 4818 / +31 40 245
English: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Maltese: Reazzjoni għallMediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS)
English: Ventricular tachycardia/fibrillation, sudden death (see section 4.4)11
Maltese: Takikardija/ fibrillazzjoni ventrikulari, mewt għallgħarrieda (ara taqsima 4.4)11
English: Olanzapine Glenmark 20 mg tablets are available in aluminium foil blisters of 28, 35, 56, 70 and 98 tablets
Maltese: Olanzapine Glenmark 20 mg pilloli jiġu f'folji tal-fojl tal-aluminju ta' 28, 35, 56, 70 u 98 pillola
English: Olanzapine Glenmark 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg are available in aluminium foil blisters of 28, 56, 70 and 98tablets
Maltese: Olanzapine Glenmark 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg jiġu f'folji tal-fojl tal-aluminju ta' 28, 35, 56, 70 u 98 pillola
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: 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 fit-tul (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: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Maltese: Sinjali oħra jistgħu jinkludu creatine phosphokinase elevat, mijoglobina flawrina (rabdomajoliżi) u insuffiċjenza akuta renali.
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: 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: Bradycardia QTc prolongation (see section 4.4)
Maltese: Bradikardija QTc imtawwal (ara taqsima 4.4)
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' 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: Olanzapine Glenmark contains aspartame
Maltese: Olanzapine Glenmark fih Aspartame:
English: Tardive dyskinesia11
Maltese: Disartrja Temtim11
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 taqsima 4.8).
English: Thromboembolism (including pulmonary embolism and deep vein thrombosis) (see section 4.4)
Maltese: Tromboemboliżmu (inkluż l-emboliżmu pulmonari u t-trombożi tal-vini fil-fond) (ara taqsima 4.4)
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; -1 adrenerġiċi; riċetturi histamine H1.
English: Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4).
Maltese: Komuni ħafna: Żieda ta' aminotransferases tal-fwied (ALT/AST; ara taqsima 4.4).
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 lgħan ewlieni ta' rikorrenza bipolari (olanzapine 30.0%, lithium 38.3%; p = 0.055).
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 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: 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 Glenmark with alcohol
Maltese: Olanzapine Glenmark mal-alkoħol
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' leliminazzjoni medja twalet (51.8 paragun ma' 33.8 siegħa) u t-tneħħija tnaqqset (17.5 paragun ma' 18.2 l/hr).
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: 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: 25 % was common (2.5 %).
Maltese: (Ara taqsimiet 4.5 u 5.2)
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Maltese: Il-grad ta' tibdil fil-kolesterol totali waqt is-sawm, kolesterol tat-tip LDL, trigliċeridi, u prolactin (ara taqsimiet 4.4 u 4.8) kien akbar fl-adolexxenti milli fl-adulti.
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: Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0)40 35 48 10
Maltese: Tél/Tel: + 46 (0) 40 35 48 10