FrancophonIA/ELRC3.0 huggingface dataset:
English: (19) Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase.
Maltese: (19) Frekwenza tal-pazjenti li għandhom bidla tal-QTc minn <450 msek għal ≥450 msek b'żieda ta' ≥30 msek.
English: Seroquel XR contains a substance called quetiapine.
Maltese: Seroquel XR fiħ is-sustanza attiva quetiapine.
English: In short-term placebo-controlled clinical trials with Seroquel in paediatric patients with schizophrenia, the incidence of suicide related events was 1.4% (2/147) for quetiapine and 1.3% (1/75) for placebo in patients <18 years of age.
Maltese: Fi provi kliniċi kontrollati bi plaċebo fuq żmien qasir b'Seroquel f'pazjenti pedjatriċi b'skizofrenija, il-frekwenza ta' każijiet relatati mas-suwiċidju kienet 1.4% (2/147) għal quetiapine u 1.3% (1/75) għall-pazjenti fuq plaċebo <18-il sena.
English: (20) Cases of suicidal ideation and suicidal behaviours have been reported during Seroquel XR therapy or early after treatment discontinuation (see Sections 4.4 and 5.1).
Maltese: (20) Każijiet ta' ħsibijiet dwar suwiċidju u imġieba ta' suwiċidju kienu irrappurtati waqt terapija b'Seroquel XR jew kmieni wara li twaqqfet il-kura (ara Sezzjonijiet 4.4 u 5.1).
English: Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The pharmacokinetics of quetiapine were not significantly altered by co-administration of the antidepressants imipramine (a known CYP 2D6 inhibitor) or fluoxetine (a known CYP 3A4 and CYP 2D6 inhibitor).
Maltese: Il-farmakokinetika ta' quetiapine ma nbidlitx b'mod sinifikanti bl-għotja fl-istess ħin ma' lantidepressanti imipramine (magħruf li hu impeditur ta' CYP 2D6) jew fluoxetine (magħruf li hu impeditur ta' CYP 3A4 u CYP 2D6).
English: There was no difference in magnitude of effect between the patients who received 300 mg Seroquel IR and those who received 600 mg dose.
Maltese: Ma kienx hemm differenza fid-daqs ta' l-effett bejn pazjenti li rċievew 300 mg Seroquel IR u dawk li rċievew doża ta' 600 mg.
English: General disorders and administration site conditions Very common Withdrawal (discontinuation) symptoms 1, 10
Maltese: Sintomi ta' twaqqif (ma jitkomplix jingħata) 1, 10
English: The pharmacokinetics of sodium valproate and quetiapine were not altered to a clinically relevant extent when co-administered.
Maltese: Il-farmakokinetika ta' sodium valproate u quetiapine ma nbidlux sal-punt li seta' jkun hemm rilevanza klinika meta ngħataw flimkien.
English: The recommended daily dose is 300 mg.
Maltese: Id-doża rakkomandata ta' kuljum hija 300 mg.
English: Elderly patients with dementia-related psychosis: Seroquel XR is not approved for the treatment of dementia-related psychosis.
Maltese: Seroquel XR mhux approvat għall-kura ta' psikożi relatata mad-demenzja.
English: Approximately 73% of a radiolabelled drug was excreted in the urine and 21% in the faeces with less than 5% of the total radioactivity representing unchanged drug-related material.
Maltese: Madwar 73% tal-mediċina radjutikkettata kienet eskretata fl-awrina u 21% fl-ippurgar b'anqas minn 5% tar-radjuattività totali tirrapreżenta il-materjal relatat mal-mediċina mhux mibdul.
English: DK - Denmark AstraZeneca A/S Roskildevej 22
Maltese: AstraZeneca A/S Roskildevej 22 Albertslund Denmark
English: Each tablet contains 150 mg quetiapine (as fumarate)
Maltese: Kull pillola fiha 150 mg quetiapine (bħala fumarate).
English: Quetiapine does not produce dopamine D2-receptor supersensitivity after chronic administration.
Maltese: Quetiapine ma jikkawżax supersensittività tar-riċettur-D2 ta' dopamine wara li jingħata b'mod kroniku.
English: 5 blisters of 10 tablets
Maltese: 5 folji ta'10 pilloli
English: In a short-term (9 week) study non-demented elderly patients (aged 66 to 89 years) with major depressive disorder, Seroquel XR dosed flexibly in the range of 50 mg to 300 mg/day demonstrated superior efficacy to placebo in reducing depressive symptoms as measured by improvement in MADRS total score (LS mean change vs placebo -7.54).
Maltese: Studju fuq żmien qasir (9 ġimgħat) f'pazjenti anzjani li ma jsofrux b'demenzja (età bejn 66 sa 89 sena) b'disturb depressiv kbir, Seroquel XR mogħti b'dożi flessibli f'medda ta' bejn 50 mg sa 300 mg/jum wera li kellu effikaċja superjuri fuq plaċebo biex jitnaqqsu s-sintomi depressivi hekk kif imkejjel bittitjib fil-punteġġ totali MADRS (medja tal-bidla LS vs plaċebo -7.54).
English: Dysphagia:
Maltese: Aċċessjonijiet:
English: In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for major depressive episodes in bipolar disorder and major depressive disorder (see sections 4.8 and 5.1).
Maltese: Fi provi kliniċi kontrollati bi plaċebo f'pazjenti adulti quetiapine kien assoċjat ma' żieda fil-każijiet ta' sintomi ekstrapiramidali (EPS) meta mqabbel mal-plaċebo f'pazjenti ikkurati għall-epsidoji ta' depressjoni kbira f'disturbi bipolari u disturbi ta' depressjoni kbira (ara sezzjonijiet 4.8 u 5.1).
English: Patients should be observed for signs and symptoms of infection and neutrophil counts followed (until they exceed 1.5 X 109/L).
Maltese: Il-pazjenti għandu jiġu osservati għal sinjali u sintomi ta' infezzjoni u lgħadd tan-newtrofili jiġu segwiti (sakemm jilħqu 1.5 X 109/L) (Ara sezzjoni 5.1).
English: The safety profile in the MDD population was shown consistent with the already known safety profile of quetiapine in other indications.
Maltese: Il-profil ta' sigurtà fil-popolazzjoni bl-MDD intwera li huwa konsistenti mal-profil ta' sigurtà diġà magħruf ta' quetiapine f'indikazzjonijiet oħrajn.
English: 6 blisters of 10 tablets
Maltese: 6 folji ta'10 pilloli
English: Do not take Seroquel XR if: you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel XR (see section 6: Further information) you are taking any of the following medicines: - some medicines for HIV - azole medicines (for fungal infections) - erythromycin or clarithromycin (for infections) - nefazodone (for depression).
Maltese: • Jekk qed tieħu xi waħda minn dawn il-mediċini: xi mediċini għall- HIV mediċini azole (għall-infezzjonijiet tal-fungu) erythromycin jew clarithromycin (għall-infezzjonijiet) nefazodone (għad-depressjoni)
English: Each tablet contains 200 mg quetiapine (as fumarate)
Maltese: Kull pillola fiha 200 mg quetiapine (bħala fumarate).
English: Seroquel XR 50 mg prolonged-release tablets Seroquel XR 150 mg prolonged-release tablets Seroquel XR 200 mg prolonged-release tablets Seroquel XR 300 mg prolonged-release tablets Seroquel XR 400 mg prolonged-release tablets
Maltese: Seroquel XR 50 mg pilloli li jerħu l-mediċina bil-mod Seroquel XR 150 mg pilloli li jerħu l-mediċina bil-mod Seroquel XR 200 mg pilloli li jerħu l-mediċina bil-mod Seroquel XR 300 mg pilloli li jerħu l-mediċina bil-mod Seroquel XR 400 mg pilloli li jerħu l-mediċina bil-mod
English: In elderly patients with major depressive episodes in MDD, dosing should begin with 50 mg/day on Days 1-3, increasing to 100 mg/day on Day 4 and 150 mg/day on Day 8.
Maltese: F'pazjenti anzjani b'episodji ta' depressjoni kbira f'MDD, id-dożaġġi għandhom jibdew b'50 mg/jum f'Jiem 1-3, jiżdiedu għal 100 mg/jum f'Jum 4 u 150 mg/jum f'Jum 8.
English: This risk persists until significant remission occurs.
Maltese: Dan ir-riskju jippersisti sakemm ikun hemm fejqan sinifikanti.
English: Neuroleptic Malignant Syndrome:
Maltese: Sindrome Newrolettika Malinna:
English: The incidences of ADRs associated with quetiapine therapy, are tabulated below according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group 1995).
Maltese: Il-frekwenza ta' ADRs assoċjati ma' terapija b'quetiapine, qegħdin f'tabella hawn taħt fil-format rakkomandat mill-Kunsill Għall-Organizzazzjonijiet Internazzjonali tax-Xjenzi Mediċi (CIOMS III Grupp ta' Ħidma 1995).
English: The daily dose at the start of therapy is 300 mg on Day 1 and 600 mg on Day 2.
Maltese: Id-doża ta' kuljum fil-bidu tat-terapija hija 300 mg f'Jum 1 u 600 mg f'Jum 2.
English: 1 blister of 10 tablets
Maltese: Folja 1 ta'10 pilloli
English: However, survival has also been reported following acute overdoses of up to 30 grams.
Maltese: Madankollu, sopravivenza kienet ukoll irrappurtata wara dożi eċċessivi akuti sa 30 gramma.
English: The primary outcome variable in the placebo-controlled trial was change from baseline to final assessment in the PANSS total score.
Maltese: Il-fini varjabbli ewlieni fil-prova ikkontrollata bil-plaċebo kienet il-bidla minn stima finali fil-punteġġ totali PANSS.
English: Occurs predominantly during the early weeks of treatment (10) The following withdrawal symptoms have been observed most frequently in acute placebo-controlled, monotherapy clinical trials, which evaluated discontinuation symptoms: insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability.
Maltese: Is-sintomi ta' twaqqif li ġejjin dehru l-aktar frekwenti fi provi kliniċi b'monoterapija ikkontrollati bi-plaċebo b'mod akut, li kienu qed jevalwaw is-sintomi tat-twaqqif: insomnja, dardir, uġigħ ta' ras, dijarea, rimettar, sturdament, u irritabilità.
English: In a short-term placebo-controlled monotherapy trial in elderly patients with major depressive disorder, the aggregated incidence of extrapyramidal symptoms was 9.0% for Seroquel XR and 2.3% for placebo.
Maltese: Fi prova fuq żmien qasir b'monoterapija ikkontrollata bi plaċebo f'pazjenti anzjani b'disturb depressiv kbir, il-frekwenza kollettiva tas-sintomi ekstrapiramidali kienet 9.0% għal Seroquel XR u 2.3% għallplaċebo.
English: Each tablet contains 400 mg quetiapine (as fumarate)
Maltese: Kull pillola fiha 400 mg quetiapine (bħala fumarate).
English: Absorption:
Maltese: Assorbiment
English: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel Belgium
Maltese: B-1180 Brussel Belgium
English: In both bipolar depression and MDD, the incidence of the individual adverse events (eg, akathisia, extrapyramidal disorder, tremor, dyskinesia, dystonia, restlessness, muscle contractions involuntary, psychomotor hyperactivity and muscle rigidity) did not exceed 4% in any treatment group.
Maltese: Kemm f'depressjoni bipolari kif ukoll f'MDD, il-frekwenza tal-każijiet avversi (eż akatiżja, disturb ekstrapiramidali, tregħid, diskajniżja, distonja, irrikwjetezza, ġbid muskolari involontarju, iperattività psikomotriċi u riġidità muskolari) ma qabżux l-4% fl-ebda grupp ta' kura.
English: • treatment of schizophrenia including preventing relapses in stable schizophrenic patients who have been maintained on Seroquel XR.
Maltese: • trattament tal-iskizofrenija nkluż il-prevenzjoni ta' rikaduti f'pazjenti skizofreniċi stabbli li nżammu fuq Seroquel XR.
English: Anaphylactic reaction6
Maltese: Suffejra6 , Epatite6
English: A 26-week open-label extension to the acute trials (n= 380 patients), with Seroquel flexibly dosed at 400-800 mg/day, provided additional safety data.
Maltese: Estenzjoni ope label ta' 26 gimgħa mal-provi akuti (n=380 pazjent), b'Seroquel mogħti skond il-bżonn b'dożi ta' 400-800 mg/jum, ipprovda aktar dejta dwar is-sigurtà.
English: INFORMATION IN BRAILLE Seroquel XR 200 mg
Maltese: INFORMAZZJONI BIL- BRAILLE Seroquel XR 200 mg
English: Seroquel XR achieves peak quetiapine and norquetiapine plasma concentrations at approximately 6 hours after administration (Tmax).
Maltese: Seroquel XR jilħaq l-ogħla konċentrazzjonijiet ta' quetiapine u norquetiapine fil-plażma madwar 6 sigħat wara li jingħata (Tmax).
English: Macrogol
Maltese: Takikardija
English: The mean clearance of quetiapine in the elderly is approximately 30 to 50% lower than that seen in adults aged 18 to 65 years.
Maltese: Il-medja tat-tneħħija ta' quetiapine fl-anzjani hija madwar 30 sa 50% aktar baxxa minn dik li tidher fladulti bejn it-18 u 65 sena.
English: The two adjunct (add-on) therapy studies, in patients with inadequate response to at least one initial antidepressant showed statistically and clinically relevant effects for quetiapine compared to placebo.
Maltese: Iż-żewġ studji ta' terapija (addizzjonali), f'pazjenti li ma kellhomx rispons adegwat għal mill-inqas antidepressant inizjali wieħed urew statistikament u klinikament effetti rilevanti għal quetiapine meta mqabbel mal-plaċebo.
English: The pharmacokinetics of quetiapine and norquetiapine are linear and dose-proportional for doses up to 800 mg administered once daily.
Maltese: Il-farmakokinetika ta' quetiapine u norquetiapine huma linejari u proporzjonali mad-doża sa dożi li jilħqu it-800 mg mogħtija darba kuljum.
English: An application for a type II variation to the terms of the Marketing Authorisation of Seroquel XR (NL/H/156/08-011/II/058) submitted by the marketing authorisation holder (MAH), Astra Zeneca AB, via Mutual Recognition Procedure (MRP) to include treatment of recurrent episodes in patients with Major Depressive Disorders (MDD), excluding the use as initial treatment and used when patients cannot be appropriately managed on alternative antidepressant treatment was rejected by all involved Member States on 15 May 2009.
Maltese: L-applikazzjoni għal varjazzjoni tat-tip II għat-termini tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ta' Seroquel XR (NL/H/156/08-011/II/058) imressqa mid-detentur tal-awtorizzazzjoni għat-tqegħid fisSuq (MAH), Astra Zeneca AB, permezz tal-Proċedura ta' Rikonoxximent Reċiproku (MRP) sabiex jiġi nkluż it-trattament ta' episodji rikorrenti f'pazjenti b'Disturbi Depressivi Maġġuri (MDD), minbarra l-użu bħala trattament inizjali u jintuża meta l-pazjenti, ma jistgħux jiġu kkontrollati kif xieraq permezz ta' trattament b'antidepressanti alternattivi ġiet miċħuda mill-Istati Membri kollha involuti fil-15 ta' Mejju 2009.
English: INFORMATION IN BRAILLE Seroquel XR 150 mg
Maltese: INFORMAZZJONI BIL- BRAILLE Seroquel XR 150 mg
English: 10 prolonged-release tablets 30 prolonged-release tablets 50 prolonged-release tablets 60 prolonged-relaease tablets 100 prolonged-release tablets
Maltese: 10 pilloli li jerħu l-mediċina bil-mod 30 pilloli li jerħu l-mediċina bil-mod 50 pilloli li jerħu l-mediċina bil-mod 60 pilloli li jerħu l-mediċina bil-mod
English: Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatinine phosphokinase.
Maltese: Sindrome newrolettika malinna kienet assoċjata ma' kura b'antipsikotiċi, inkluż quetiapine (ara sezzjoni 4.8). Manifestazzjonijiet kliniċi inkluż ipertermija, stat mentali alterat, riġidità muskolari, instabbilità awtonomika, u żieda tal-creatinine phosphokinase.
English: Changes in thyroid function tests have also been observed in children and adolescents.
Maltese: Bidliet fit-testijiet tal-funzjoni tat-tajrojd deheru wkoll fi tfal u adolexxenti.
English: The short-term monotherapy studies showed that patients treated with quetiapine had more adverse events and a higher dropout rate due to adverse events when compared to the active controlsSelective serotonin reuptake inhibitor - duloxetine and escitalopram.
Maltese: L-istudji ta' monoterapija fuq żmien qasir urew li l-pazjenti ttrattati bi quetiapine kellhom aktar avvenimenti avversi u rata ogħla ta' tluq bikri minħabba avvenimenti avversi meta mqabbla malkontrolli attivi - Inibitur tat-teħid mill-ġdid tas-serotonin selettiv - duloxetine u escitalopram.
English: In placebo-controlled clinical trials with children and adolescent patients treated with Seroquel, quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for schizophrenia and bipolar mania (see section 4.8).
Maltese: Fi provi kontrollati bi plaċebo b'pazjenti tfal u adolexxenti ikkurati b'Seroquel, quetiapine kien assoċjat ma' żieda fil-frekenza ta' sintomi ekstrapiramidali (EPS) meta mqabbla mal-plaċebo f'pazjenti ikkurati għal skizofrenija u manija bipolari (ara sezzjoni 4.8).
English: Acute withdrawal symptoms such as insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability have been described after abrupt cessation of quetiapine.
Maltese: Sintomi ta' meta jitwaqqaf f'daqqa bħal insomnja, dardir, uġigħ ta' ras, dijarea, rimettar, sturdament u irritabilità kienu deskritti wara li quetiapine twaqqaf f'daqqa.
English: It was nevertheless noted that supportive indirect evidence indicates that an effect can be expected after current or earlier failure (insufficient response or intolerance) with one or two antidepressants.
Maltese: Madankollu kien innutat li evidenza indiretta ta' appoġġ tindika li jista' jkun mistenni effett wara falliment attwali jew preċedenti (rispons mhux suffiċjenti jew nuqqas ta' tolleranza) b'antidepressant wieħed jew tnejn.
English: (3) Asymptomatic elevations in serum transaminase (ALT, AST) or gamma-GT-levels have been observed in some patients administered quetiapine.
Maltese: (3) Żiediet ta' transaminase (ALT, AST) jew fil-livelli ta' gamma-GT mingħajr sintomi dehru f'xi pazjenti li ngħataw quetiapine.
English: In post marketing, QT prolongation was reported with quetiapine at the therapeutic doses (see Section 4.8) and in overdose (see Section 4.9).
Maltese: Wara li tqiegħed fis-suq, it-titwil QT kien irrappurtat b'quetiapine bid-dożi terapewtiċi (ara Sezzjoni 48) u b'doża eċċessiva (ara Sezzjoni 4.9).
English: Norway
Maltese: Austra
English: Less than 1% of patients had an increase to a prolactin level >100 ug/L.
Maltese: Anqas minn 1% tal-pazjenti kellhom żieda għal livell ta' prolaktin >100 μg/L.
English: Quetiapine is extensively metabolized by the liver.
Maltese: Quetiapine jiġi metabolizzat b'mod estensiv mill-fwied.
English: As with other antipsychotics, caution is recommended when treating patients with a history of seizures (see Section 4.8).
Maltese: Bħal antipsikotiċi oħra, hija rakkomandata l-kawtela meta jkunu qed jiġu ikkurati pazjenti li fil-passat kellhom aċċessjonijiet (ara Sezzjoni 4.8).
English: INFORMATION IN BRAILLE Seroquel XR 400 mg
Maltese: INFORMAZZJONI BIL- BRAILLE Seroquel XR 400 mg
English: INFORMATION IN BRAILLE Seroquel XR 50 mg
Maltese: INFORMAZZJONI BIL- BRAILLE Seroquel XR 50 mg
English: 10 blisters of 10 tablets
Maltese: 10 folji ta'10 pilloli
English: • Rapid heartbeat.
Maltese: • Diffikulta sabiex tibla'
English: Seroquel XR 150 mg prolonged-release tablets
Maltese: Seroquel XR 150 mg prolongedrelease tablets
English: It is important that the lowest effective dose is used for maintenance therapy.
Maltese: Huwa importanti li tintuża l-aktar doża baxxa li tkun effettiva għat-terapija ta' manteniment.
English: Dry mouth
Maltese: Tqala u Treddigħ
English: It is this combination of receptor antagonism with a higher selectivity for 5HT2 relative to D2- receptors, which is believed to contribute to the clinical antipsychotic properties and low extrapyramidal undesirable effect (EPS) liability of Seroquel compared to typical antispychotics.
Maltese: Hija din il-kombinazzjoni ta' antagoniżmu għar-riċetturi b'selettività ogħla għal 5HT2 meta mqabbla marriċetturi-D2, li hi maħsuba li tikkontribwixxi għal-karatteristiċi kliniċi antipsikotiċi u effetti ekstrapiramidali mhux mixtieqa (EPS) baxxi ta' Seroquel meta mqabbel ma' antipsikotiċi tipiċi.
English: The percentage of quetiapine treated patients who gained ≥7% of body weight ranged from 5.3% for the 50 mg daily dose to 15.5% for the 400 mg daily dose (with lower gain for the 600 and 800 mg daily doses), compared to 3.7% for placebo treated patients.
Maltese: 5% għddoża ta' 400 mg kuljum (b' żidiet anqas għad-dożi ta' 600 u 800 mg kuljum, mqabbel ma 3.7% għallpazjenti kkurati bi plaċebo
English: INFORMATION IN BRAILLE Seroquel XR 300 mg
Maltese: INFORMAZZJONI BIL- BRAILLE Seroquel XR 300 mg
English: 3 blisters of 10 tablets
Maltese: 3 folji ta'10 pilloli
English: Each tablet contains 300 mg quetiapine (as fumarate)
Maltese: Kull pillola fiha 300 mg quetiapine (bħala fumarate).
English: Cardiovascular:
Maltese: Kardjovaskulari:
English: Seroquel Prolong 150 mg prolonged-release tablets
Maltese: Seroquel Prolong 150 mg prolongedrelease tablets
English: Seroquel XR 200 mg prolonged-release tablets
Maltese: Seroquel XR 200 mg prolongedrelease tablets
English: Seroquel XR 50 mg prolonged-release tablets
Maltese: Seroquel XR 50 mg prolongedrelease tablets
English: Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
Maltese: Informazzjoni minn provi kliniċi wrew żieda fir-riskju ta' ħsibijiet ta' suwiċidju u/jew imġieba ta' suwiċidju f' adulti żgħar ta' eta anqas minn 25 sena bid-depressjoni.
English: The mean dose of Seroquel XR during the randomised phase was 177 mg/day.
Maltese: Id-doża medja ta' Seroquel XR waqt ilfażi randomised kienet 177 mg/jum.
English: Neither low dose (400 mg/day) nor high dose regimen (800 mg/day) quetiapine was superior to placebo with respect to the percentage of patients achieving response, defined as ≥30% reduction from baseline in PANSS total score.
Maltese: La l-kors bid-doża baxxa (400 mg/jum) u l-anqas dak bid-doża għolja (800 mg/jum) ta' quetiapine ma'kien superjuri għal plaċebo f'dak li hu l-perċentwali ta' pazjenti li kisbu rispons, definit bħala ≥30% tnaqqis mil-linja bażi fil-punteġġ totali PANSS.
English: In this study patients randomised to Seroquel XR received 50 mg/day on Days 1-3, the dose could be increased to 100 mg/day on Day 4, 150 mg/day on Day 8 and up to 300 mg/day depending on clinical response and tolerability.
Maltese: F'dan l-istudju pazjenti li kienu randomised għal Seroquel XR irċievew 50 mg/jum f'Jiem 1-3, id-doża setgħet tiżdied sa' 100 mg/jum f'Jum 4, 150 mg/jum f'Jum 8 u sa' 300 mg/jum skond ir-rispons kliniku u t-tolerabilità.
English: In clinical trials and use in accordance with the SPC, quetiapine was not associated with a persistent increase in absolute QT intervals.
Maltese: Fi provi kliniċi u waqt l-użu skond l-SPC, quetiapine ma kienx assoċjat ma' żieda persistenti flintervalli QT assoluti.
English: Seroquel XR 400 mg prolonged-release tablets
Maltese: Seroquel XR 400 mg prolongedrelease tablets
English: In three out of four short term (up to 8 weeks) monotherapy studies, in patients with major depressive disorder, Seroquel XR 50 mg, 150 mg and 300 mg/day demonstrated superior efficacy to placebo in reducing depressive symptoms as measured by improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score (LS mean change vs. placebo of 2-4 points).
Maltese: Fi tlieta minn erba' studji b'monoterapija għal żmien qasir (sa 8 ġimgħat), f'pazjenti b'disturb depressiv kbir, Seroquel XR 50 mg, 150 mg u 300 mg/jum urew effikaċja superjuri minn tal-plaċebo biex jitnaqqsu s-sintomi depressivi hekk kif imkejjel mit-titjib fl-Iskala ta' Depressjoni Ratata skond Montgomery-Åsberg (MADRS) punteġġ totali (medja tal-bidla LS vs plaċebo ta' 2-4 punti).
English: Strength
Maltese: Neutropenija
English: Hyperglycaemia:
Maltese: Disfaġja:
English: Seroquel Prolong 400 mg prolonged-release tablets
Maltese: Seroquel Prolong 400 mg prolongedrelease tablets
English: Seroquel XR 300 mg prolonged-release tablets
Maltese: Seroquel XR 300 mg prolongedrelease tablets
English: In vitro CYP inhibition is observed only at concentrations approximately 5 to 50 fold higher than those observed at a dose range of 300 to 800 mg/day in humans.
Maltese: Inibizzjoni in vitro ta' CYP tidher biss b'konċentrazzjonijiet minn 5 sa 50 darba ogħla minn dawk li jiġu osservati fil-medda ta' 300 sa 800 mg/jum fil-bnedmin.
English: Seroquel Prolong 200 mg prolonged-release tablets
Maltese: Seroquel Prolong 200 mg prolongedrelease tablets