FrancophonIA/ELRC3.0 huggingface dataset:
English: In ST segment elevation myocardial infarction, fewer patients on Clopidogrel Zentiva had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Maltese: Fir-rigward ta' każi ta' infart mijokardiku b'elevazzjoni tas-segment ST, l-għadd ta' pazjenti li ngħataw Clopidogrel Zentiva u li għaddew minn avvenimenti iskemiki kien inqas mill-għadd tal-pazjenti li ngħataw plaċebo (262 u 377 rispettivament fl-istudju CLARITY, u 2,121 u 2,310 rispettivament fl-istudju COMMIT).
English: Clopidogrel Zentiva is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Zentiva huwa prodott mediċinali li fih is-sustanza attiva klopidogrel.
English: Clopidogrel Zentiva is used to prevent problems caused by blood clots in adults who have:
Maltese: Clopidogrel Zentiva jintuża biex jipprevjeni problemi kkawżati minn emboli f'adulti li:
English: • recently had a myocardial infarction (heart attack).
Maltese: • riċentement ġarrbu infart mijokardijaku (attakk tal-qalb).
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel Zentiva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Clopidogrel Zentiva.
English: The active substance in Clopidogrel Zentiva, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva ta' Clopidogrel Zentiva, il-klopidogrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: In acute coronary syndrome, treatment generally starts with a loading dose of one 300-mg tablet or four 75-mg tablets.
Maltese: Għas-sindromu koronarju akut, ġeneralment it-trattament jibda b'doża ta' tagħbija (loading dose) ta' pillola waħda ta' 300-mg jew erba' pilloli ta' 75-mg.
English: This summary was last updated in 11-2011.
Maltese: DIF fit-23 ta' Awwissu 2011.
English: Clopidogrel Zentiva was more effective than aspirin at preventing new ischaemic events.
Maltese: Clopidogrel Zentiva kien iktar effikaċi mill-aspirina fil-prevenzjoni ta' avvenimenti iskemiċi.
English: In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%.
Maltese: Inkwantu s-sindromu koronarju akut mingħajr elevazzjoni tas-segment ST, apparagun ma' plaċebo, b'mod ġenerali, it-tnaqqis relattiv fir-riskju ta' avveniment iskemiku kien 20%.
English: In the study in atrial fibrillation patients, Clopidogrel Zentiva taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.
Maltese: Fl-istudju fuq pazjenti b'fibrillazzjoni atrijali, it-teħid ta' Clopidogrel Zentiva flimkien mal-aspirina naqqas ir-riskju ta' avveniment iskemiku ġdid bi 11% apparagun mat-teħid ta' plaċebo ma' aspirina.
English: In atrial fibrillation, Clopidogrel Zentiva has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy.
Maltese: Fl-istudju dwar il-fibrillazzjoni atrijali Clopidogrel Zentiva tqabbel ma' plaċebo (it-tnejn meħuda malaspirina) matul studju wieħed li involva madwar 7,500 pazjent li kellhom tal-inqas fattur wieħed ta' riskju li jgħaddu minn avvenimenti vaskulari u li ma setgħetx issirilhom terapija bl-għoti tal-antagonisti tal-vitamina K.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Zentiva is used together with aspirin, the dose of which should not be higher than 100 mg.
Maltese: Fil-każi ta' sindromu koronarju akut u ta' fibrillazzjoni atrijali, Clopidogrel Zentiva jittieħed flimkien ma' aspirina u f'dal-każi d-doża m'għandhiex taqbeż il-100 mg.
English: Clopidogrel Zentiva has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted for up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Clopidogrel Zentiva with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Maltese: Clopidogrel Zentiva tqabbel ukoll ma' plaċebo f'żewġ studji li involvew pazjenti b'elevazzjoni tat-taqsima ST: L-istudju CLARITY involva madwar 3,000 pazjent u dam madwar tmint ijiem, mentri l-istudju COMMIT involva madwar 46,000 pazjent li ngħataw Clopidogrel Zentiva kemm bil-metoprolol (mediċina oħra użata għall-problemi fil-qalb jew għall-pressjoni għolja) u kemm mingħajrha tul erba' ġimgħat.
English: This authorisation was based on the authorisation granted to Plavix in 1998 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Plavix fl-1998 (‘kunsens infurmat').
English: In acute coronary syndrome, Clopidogrel Zentiva has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year).
Maltese: Fis-sindromu koronarju akut, Clopidogrel Zentiva tqabbel ma' plaċebo (trattament finta) fi studju wieħed li involva 'l fuq minn 12,000 pazjent b'non-elevazzjoni tat-taqsima ST.
English: The standard dose of Clopidogrel Zentiva is one 75-mg tablet once a day.
Maltese: Id-doża rakkomandata ta' Clopidogrel Zentiva hija pillola waħda ta' 75-mg kuljum.
English: Clopidogrel Zentiva has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or ischaemic stroke, or who had established peripheral arterial disease.
Maltese: Clopidogrel Zentiva tqabbel mal-aspirina fi studju msejjaħ CAPRIE, li inkluda madwar 19,000 pazjent li riċentement kienu sofrew attakk tal-qalb jew puplesija iskemika, jew li kienet ħarġitilhom xi marda flarterji periferiċi.
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Maltese: Is-sindromu koronarju akut huwa ġabra ta' problemi fil-qalb li jinkludu l-attakki tal-qalb u l-anġina instabbli (u diversi tipi ta' uġigħ fis-sider).
English: What is Clopidogrel Zentiva?
Maltese: X'inhu Clopidogrel Zentiva?
English: Clopidogrel Zentiva is converted into its active form in the body.
Maltese: Il-konverżjoni ta' Clopidogrel Zentiva fil-forma attiva tiegħu ssir fil-ġisem.
English: Clopidogrel Zentiva can be started between a few days and 35 days after the attack;
Maltese: Clopidogrel Zentiva jista' jinbeda flewwel ftit jiem wara l-attakk u sa 35 ġurnata wara;
English: This showed that Clopidogrel Zentiva reduces the risk of an event.
Maltese: Dan wera li Clopidogrel Zentiva jnaqqas ir-riskju ta' avvenimenti bħal dawn.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Maltese: Imbagħad it-trattament jitkompla b'doża standard ta' 75-mg darba kuljum tul tal-inqas erba' ġimgħat (fil-każi ta' infart mijokardiku b'elevazzjoni tas-segment ST) jew tul sa 12-il xahar (fil-każi ta' anġina instabbli jew infart mijokardiku ‘mhux tal-mewġa Q'.
English: How has Clopidogrel Zentiva been studied?
Maltese: Kif ġie studjat Clopidogrel Zentiva?
English: Why has Clopidogrel Zentiva been approved?
Maltese: Għaliex ġie approvat Clopidogrel Zentiva?
English: 6 (6 x 1) pre-filled pens + 6 (6 x 1) swab (multipack)
Maltese: 6 (6x1) pinen mimlijin għal-lest + 6 (6x1) msieħ (pakkett multiplu)
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: Dyspnoea 23
Maltese: Dispnea 23
English: Metabolic Risk
Maltese: Riskju metaboliku
English: Metabolic syndrome29
Maltese: Sindromu metaboliku29
English: (13) Platelets ≤100 x 10
Maltese: 13. Plejtlits ≤100 x 10
English: Agranulocytosis26
Maltese: Agranuloċitosi26
English: Hypersensitivity (including allergic skin reactions)
Maltese: Sensittività eċċessiva (inklużi reazzjonijiet allerġiċi filġilda)
English: Tablet coating: hypromellose, macrogol, titanium dioxide (E171).
Maltese: Kisja tal-pillola: hypromellose, macrogol, titanium dioxide (E171).
English: Pharmacodynamic effects:
Maltese: Effetti farmakodinamiċi:
English: dizziness, and irritability.
Maltese: sturdament, u irritabilità.
English: Neutropenia 1
Maltese: Irritabilità3 1.
English: Combined pack
Maltese: Pakkett ikkombinat
English: • Abnormal muscle movements.
Maltese: • Movimenti muskolari mhux normali.
English: Carton (pack) contents
Maltese: Kontenut tal-kartuna (pakkett)
English: • Thioridazine or Lithium (other anti-psychotic medicines).
Maltese: • Thioridazine jew Lithium (mediċini anti-psikotiċi oħra).
English: (For cataracts/lens opacities see section 5.1).
Maltese: (Għal katarretti/opaċitajiet tal-lenti ara sezzjoni 5.1).
English: Distribution Quetiapine is approximately 83% bound to plasma proteins.
Maltese: Quetiapine jintrabat madwar 83% mal-proteini tal-plasma.
English: Toxic Epidermal Necrolysis, Erythema Multiforme
Maltese: Epidermali Tossika, Eritema Multiforme
English: Severe Neutropenia and agranulocytosis:
Maltese: Newtropenja severa u agranuloċitosi:
English: Schizophrenia
Maltese: Skizofrenija
English: • Erythromycin or clarithromycin (for infections).
Maltese: • Erythromycin jew clarithromycin (għall-infezzjonijiet).
English: 3-Day Starterpack (Combined pack)
Maltese: Pakkett tal-Bidu ta' 3 ijiem (Pakkett Ikkkombinat)
English: 240 tablets
Maltese: 240 pillola
English: The available evidence from placebo-controlled clinical trials is presented in sections 4.4, 4.8, 5.1 and 5.2.
Maltese: L-evidenza disponibbli minn provi kliniċi kkontrollati bi plaċebo hija ppreżentata fis-sezzjonijiet 4.4, 4.8, 5.1 u 5
English: • Epilepsy medicines (like phenytoin or carbamazepine).
Maltese: • Mediċini għall-epilessija (bħal phenytoin jew carbamazepine).
English: Venous Thromboembolism (VTE)
Maltese: Tromboemboliżmu fil-Vini (VTE)
English: • Body temperature decreased (hypothermia).
Maltese: • Tnaqqis fit-temperatura tal-ġisem (ipotermja).
English: Decreases in free T3
Maltese: Tnaqqis fit-T3
English: Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase.
Maltese: Il-manifestazzjonijiet kliniċi jinkludu ipertermja, stat mentali alterat, riġidità muskolari, instabilità awtonomika, u żieda fil-creatine phosphokinase.
English: Extrapyramidal symptoms:
Maltese: Sintomi ekstrapiramidali:
English: Major depressive episodes in MDD
Maltese: Episodji depressivi maġġuri f'MDD
English: Lipids:
Maltese: Lipidi:
English: Quetiapine is active in tests for antipsychotic activity, such as conditioned avoidance.
Maltese: Quetiapine huwa attiv f'testijiet ta' attività antipsikotika, bħal evitazzjoni kondizzjonata.
English: See Section 4.
Maltese: Ara Sezzjoni 4.
English: Norquetiapine is primarily formed and eliminated via CYP3A4.
Maltese: Norquetiapine jiġi primarjament iffurmat u eliminat permezz ta' CYP3A4.
English: 12-October-2009
Maltese: 27 ta' April 1998 12 ta' Ottubru 2009
English: Angioedema5, StevensJohnson syndrome
Maltese: Sindromu ta' StevensJohnson5
English: • Feeling irritated.
Maltese: • Tħossok irritat.
English: Tachycardia Palpitations23
Maltese: Takikardja Palpitazzjonijiet
English: The incidences of shifts in TSH was 3.2 % for quetiapine versus 2.7 % for placebo.
Maltese: Linċidenzi ta' tibdil fit-TSH kienet ta' 3.2 % għal quetiapine kontra 2.7 % għal plaċebo.
English: Elevations in prolactin1
Maltese: Żidiet fil-prolactin1
English: • Nefazodone (for depression).
Maltese: • Nefazodone (għad-dipressjoni).
English: Dysphagia (See section 4.8) has been reported with quetiapine.
Maltese: Disfaġja (Ara sezzjoni 4.8) kienet irrapportata bi quetiapine.
English: Jaundice5 Hepatitis
Maltese: Suffejra5, Epatite
English: Lactose:
Maltese: Lattosju:
English: (see section 4.8)
Maltese: (Ara Sezzjoni 4.8)
English: • Feeling irritated
Maltese: • Tħossok irritat
English: Cardiomyopathy and Myocarditis
Maltese: Kardjomijopatija u Mijokardite
English: Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.
Maltese: Ma sarux studji formali ta' interazzjoni bi prodotti mediċinali kardjovaskulari komunement użati.
English: Uncommon Rare
Maltese: Mhux Komuni Rari
English: • Azole medicines (for fungal infections).
Maltese: • Mediċini azole (għall-infezzjonijiet fungali).
English: 6 blisters of 10 tablets 12 blisters of 5 tablets
Maltese: 6 folji ta' 10 pilloli 12-il folja ta' 5 pilloli
English: In short-term, placebo-controlled clinical trials in schizophrenia and bipolar mania the aggregated incidence of extrapyramidal symptoms was similar to placebo (schizophrenia: 7.8% for quetiapine and 8.0% for placebo; bipolar mania: 11.2% for quetiapine and 11.4% for placebo).
Maltese: Fi provi kliniċi fuq żmien qasir, ikkontrollati bi plaċebo fi skizofrenija u manija bipolari l-inċidenza aggregata tas-sintomi ekstrapiramidali kienet simili għall-plaċebo (skizofrenija: 7.8% għal quetiapine u 8.0% għal plaċebo; manija bipolari: 11.2% għal quetiapine u 11.4% għal plaċebo).
English: Quetiapine and several of its metabolites (including norquetiapine) were found to be weak inhibitors of human cytochrome P450 1A2, 2C9, 2C19, 2D6 and 3A4 activities in vitro.
Maltese: Quetiapine u ħafna mill-metaboliti tiegħu (inkluż norquetiapine) instabu li huma inibituri dgħajfa talattivitajiet taċ-ċitokromju uman P450 1A2, 2C9, 2C19, 2D6 u 3A4 in vitro.
English: Pancreatitis Intestinal obstruction/Ileus
Maltese: Pankreatite Ostruzzjoni intestinali/ileju
English: HDL cholesterol: <40 mg/dL (1.025 mmol/L) males; <50 mg/dL (1.282 mmol/L) females at any time.
Maltese: Kolesterol HDL: <40 mg/dL (1.025 mmol/L) irġiel; <50 mg/dL (1.282 mmol/L) nisa fi kwalunkwe ħin.
English: Bipolar Disorder
Maltese: Disturb bipolari
English: Tardive Dyskinesia:
Maltese: Diskinesija Tardiva:
English: • Inappropriate secretion of a hormone that controls urine volume.
Maltese: • Sekrezzjoni inadegwata ta' ormon li jikkontrolla l-volum tal-awrina.
English: Mild asthenia, peripheral oedema, irritability, pyrexia
Maltese: edema periferali, irritabilità, deni
English: Shifts in total T4, free T4, total T3 and free T3 are defined as <0.8 x LLN (pmol/L) and shift in TSH is > 5 mIU/L at any time.
Maltese: Tibdil fit-T4 totali, T4 ħieles, T3 totali u T3 ħieles huwa definit bħala <0.8 x LLN (pmol/L) u tibdil fit-TSH huwa ta' > 5 mIU/L fi kwalunkwe ħin.
English: Ferric Oxide, Yellow (E172) 25 mg, 100 mg and 150 mg tablets) Ferric Oxide, Red (E172) (25 mg tablets)
Maltese: Ferric Oxide, Yellow (E172) pilloli ta' 25 mg, 100 mg u 150 mg) Ferric Oxide, Red (E172) (pilloli ta' 25 mg)
English: • Uncontrollable movements, mainly of your face or tongue.
Maltese: • Movimenti inkontrollabbli, l-aktar ta' wiċċek jew ta' ilsienek.
English: Cytochrome P450 (CYP) 3A4 is the enzyme that is primarily responsible for the cytochrome P450 mediated metabolism of quetiapine.
Maltese: Iċ-ċitokromju P450 (CYP) 3A4 huwa l-enzim primarjament responsabbli għall-metaboliżmu ta' quetiapine medjat miċ-ċitokromju P450.
English: (31) See Section 4.6.
Maltese: 31. Ara Sezzjoni 4.6.
English: • Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad.
Maltese: • Dipressjoni bipolari u episodji depressivi maġġuri f'disturb depressiv maġġuri: fejn tħossok imdejjaq.
English: Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine (see section 4.8).
Maltese: Is-sindromu newrolettiku malinn kien assoċjat ma' kura b'antipsikotiċi, inkluż quetiapine (ara sezzjoni 4.8).
English: Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azoleantifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated.
Maltese: L-għoti konkomitanti ta' inibituri taċ-ċitokromju P450 3A4, bħal inibituri tal-protease tal-HIV, aġenti antifungali azole, erythromycin, clarithromycin u nefazodone, huwa kontraindikat.
English: Neuroleptic malignant syndrome 1, hypothermia
Maltese: Sindromu newrolettiku malinn 1, ipotermja
English: • Worsening of pre-existing diabetes.
Maltese: • Aggravar ta' dijabete pre-eżistenti.
English: (≥1/100, <1/10), uncommon (≥1/1000, <1/100, rare (≥1/10,000, <1/1000), very rare (<1/10,000), and not known
Maltese: komuni (>1/100, <1/10), mhux komuni (>1/1000, <1/100), rari (>1/10,000, <1/1000) u rari ħafna
English: Based on adverse event reports of metabolic syndrome from all clinical trials with quetiapine.
Maltese: Abbażi ta' rapporti ta' avvenimenti avversi ta' sindromu metaboliku mill-provi kliniċi kollha bi quetiapine.
English: Elevations in serum triglyceride levels 10,30
Maltese: Żidiet fil-livelli tat-trigliċeridi fis-serum 10,30
English: Pack sizes of 20, 30, 50, 60 and 100 tablets are registered for all strengths.
Maltese: Id-daqsijiet tal-pakkett ta' 20, 30, 50, 60 u 100 pillola huma rreġistrati għall-qawwiet kollha.
English: Shifts in WBCs are defined as ≤ 3X10^9 cells/L at any time.
Maltese: Tibdil fil-WBCs huwa definit bħala ≤ 3X10^9 ċelloli/L fi kwalunkwe ħin.
English: Seroquel XR 150 mg and 300 mg/day, given as add-on treatment to ongoing antidepressant therapy (amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline or venlafaxine) demonstrated superiority over antidepressant therapy alone in reducing depressive symptoms as measured by improvement in MADRS total score (LS mean change vs. placebo of 2-3.3 points).
Maltese: Seroquel XR 150 mg u 300 mg/kuljum, mogħti bħala kura miżjuda ma' terapija kontinwa b'antidepressant (amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline jew venlafaxine) wera superjorita fuq terapija antidepressiva weħidha fit-tnaqqis tas-sintomi depressivi imkejjel b'titjib fil-punteġġ totali fuq MADRS (bidla medja fl-LS kontra plaċebo ta' 2-3.3 punti).
English: 20 tablets
Maltese: 20 pillola
English: See Section 4.4.
Maltese: Ara Sezzjoni 4.4.
English: Steady-state peak molar concentrations of the active metabolite norquetiapine are 35% of that observed for quetiapine.
Maltese: Il konċentrazzjonijiet ta' molari massimi fi stat fiss tal-metabolit attiv norquetiapine huma ta' 35% ta' dak osservat għal quetiapine.
English: Pack sizes of 10, 30, 50, 60 and 100 tablets are registered for all strengths.
Maltese: Id-daqsijiet tal-pakkett ta' 10, 30, 50, 60 u 100 pillola huma rreġistrati għall-qawwiet kollha.
English: Withdrawal (dis continuation) symptoms 1,9
Maltese: Sintomi ta' irtirar 1,9
English: (See section 4.4).
Maltese: (Ara sezzjoni 4.4).
English: Seroquel XR 400 mg/day, 600 mg/day and 800 mg/day were associated with statistically significant improvements in psychotic symptoms compared to placebo.
Maltese: Seroquel XR 400 mg/kuljum, 600 mg/kuljum u 800 mg/kuljum kienu assoċjati ma' titjib statistikament sinifikanti fis-sintomi psikotiċi meta mqabbla ma' plaċebo.
English: Tablet core: microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate, hypromellose.
Maltese: Qalba tal-pillola: microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate, hypromellose.
English: Withdrawal
Maltese: Irtirar
English: Quetiapine and norquetiapine exhibit affinity for brain serotonin (5HT2) and dopamine D1- and D2- receptors.
Maltese: Quetiapine u norquetiapine juru affinità għal serotonin fil-moħħ (5HT2) u għar-riċetturi-D1 u - D2 ta' dopamine.
English: In clinical studies of patients with MDD the incidence of suicide-related events observed in young adult patients (younger than 25 years of age) was 2.1% (3/144) for quetiapine and 1.3% (1/75) for placebo.
Maltese: Fi studji kliniċi ta' pazjenti b'MDD l-inċidenza ta' avvenimenti relatati mas-suwiċidju osservata f'pazjenti adulti żgħar (ta' anqas minn 25 sena) kienet ta' 2.1% (3/144) għal quetiapine u ta' 1.3% (1/75) għall-plaċebo.
English: 100 blisters of 1 tablet
Maltese: 100 folja ta' pillola 1
English: Elevations in blood creatine phosphokinase14
Maltese: Żidiet fil-creatine phosphokinase fid-demm 14
English: Constipation and intestinal obstruction have been reported with quetiapine (see section 4.8 Undesirable effects).
Maltese: Stitikezza u ostruzzjoni intestinali kienu rrapportati bi quetiapine (ara sezzjoni 4.8 Effetti Mhux Mixtieqa).
English: Seroquel Prolong® 50 mg Retardtabletten, Seroquel Prolong® 150 mg Retardtabletten, Seroquel Prolong® 200 mg Retardtabletten, Seroquel Prolong® 300 mg Retardtabletten, Seroquel Prolong® 400 mg Retardtabletten
Maltese: Seroquel Prolong® 200 mg Retardtabletten, Seroquel Prolong® 300 mg Retardtabletten, Seroquel Prolong® 400 mg Retardtabletten
English: Clinical efficacy:
Maltese: Effikaċja klinika:
English: Extrapyramidal symptoms3, 4
Maltese: Disturbi fis-sistema nervuża Sintomi ekstrapiramidali3, 4
English: The efficacy and safety of Seroquel was studied in a 3-week placebo controlled study for the treatment of mania (n= 284 patients from the US, aged 10-17).
Maltese: L-effikaċja u s-sigurtà ta' Seroquel kienu studjati fi studju ta' 3-ġimgħat ikkontrollat bi plaċebo għallkura ta' manija (n= 284 pazjent mill-Istati Uniti, età minn 10-17).
English: Seroquel data in combination with divalproex or lithium in acute moderate to severe manic episodes at 3 and 6 weeks is limited; however, combination therapy was well tolerated.
Maltese: Dejta dwar Seroquel f'kombinazzjoni ma' divalproex jew lithium f'episodji manijaċi akuti moderati għal severi f'ġimgħat 3 u 6 hija limitata; iżda, terapija kkombinata kienet tollerata sew.
English: Triglycerides ≥200 mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L)
Maltese: Trigliċeridi ≥200 mg/dL (≥2.258 mmol/L) (pazjenti ≥18-il sena) jew ≥150 mg/dL (≥1.694 mmol/L)
English: 10 tablets
Maltese: 10 pilloli
English: Pharmacotherapeutic group: Antipsychotics ATC code: N05A H04
Maltese: Kategorija farmakoterapewtika: AntipsikotiċiKodiċi ATC:
English: The AUC and Cmax for the active metabolite, norquetiapine, were higher, approximately 62% and 49% in children (10-12 years), respectively and 28% and 14% in adolescents (13-17 years), respectively, compared to adults.
Maltese: L-AUC u s-Cmax tal-metabolit attiv, norquetiapine, kienu ogħla, ta' madwar 62% u 49% fit-tfal (10-12-il sena), rispettivament u ta' 28% u 14% fl-adolexxenti (13-17il sena), rispettivament meta mqabbla mal-adulti .
English: INFORMATION IN BRAILLE Seroquel 25 mg, 100 mg and 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Seroquel 25 mg, 100 mg u 200 mg
English: Seroquel® 200 mg Filmtabletten, Seroquel® 300 mg Filmtabletten
Maltese: Filmtabletten, Seroquel® 300 mg Filmtabletten
English: Elevations in serum aspartate aminotransferas e (AST) 3
Maltese: Żidiet fl aspartate aminotransferas e fis-serum (AST) 3
English: Seizure 1, Restless legs syndrome, Tardive dyskinesia 1, 5,
Maltese: Sindromu tassaqajn irrikwieti, Diskinesija tardiva 1, 5,
English: Neuroleptic Malignant Syndrome:
Maltese: Sindromu Newrolettiku Malinn:
English: Interactions: See also section 4.5.
Maltese: Interazzjonijiet Ara wkoll sezzjoni 4.5.
English: Quetiapine and norquetiapine have no appreciable affinity at benzodiazepine receptors but high affinity at histaminergic and adrenergic alpha1 receptors, moderate affinity at adrenergic alpha2 receptors and moderate to high affinity at several muscarinic receptors.
Maltese: Quetiapine u norquetiapine m'għandhom l-ebda affinità apprezzabbli fir-riċetturi ta' benzodiazepine iżda affinità għolja fir-riċetturi istaminerġiċi u adrenerġiċi alpha1, affinità moderata fir-riċetturi adrenerġiċi alpha2 u affinità minn moderata għal għolja f'diversi riċetturi muskariniċi.
English: The rates of suicide related events in the active arm vs. placebo were 1.4% vs. 1.3% in the schizophrenia trial, 1.0% vs. 0% in the bipolar mania trial, and 1.1% vs. 0% in the bipolar depression trial.
Maltese: avvenimenti relatati mas-suwiċidju fil-fergħa attiva kontra plaċebo kienu ta' 1.4% kontra 1.3% fil prova ta' skizofrenija, 1.0% kontra 0% fil-prova ta' manija bipolari, u ta' 1.1% kontra 0% fil-prova ta'