FrancophonIA/ELRC3.0 huggingface dataset:
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/jum, mogħti bħala kura ulterjuri ma' terapija li baqghet għaddeja (amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline jew venlafaxine) kien superjuri fuq terapija antidepressiva waħidha biex jonqsu s-sintomi depressivi hekk kif imkejjel bit-titjib fil-punteġġ totali MADRS (medja tal-bidla LS vs plaċebo ta' 2-3.3 punti).
English: In a short-term placebo-controlled monotherapy trial with Seroquel in adolescent patients (13-17 years of age) with schizophrenia, the aggregated incidence of extrapyramidal symptoms was 12.9% for quetiapine and 5.3% for placebo, though the incidence of the individual adverse events (e.g. akathisia, tremor, extrapyramidal disorder, hypokinesia, restlessness, psychomotor hyperactivity, muscle rigidity, dyskinesia) did not exceed 4.1% in any treatment group.
Maltese: Fi prova b'monoterapija ikkontrollata bi plaċebo fuq żmien qasir b'Seroquel f'pazjenti adolexxenti (13-17-il sena) bi skizofrenija, il-frekwenza kollettiva tas-sintomi ekstrapiramidali kienet 12.9% għal quetiapine u 5.3% għall-plaċebo, għalkemm il-frekwenza tal-każijiet avversi individwali (eż akatinsja, tregħid, disturb ekstrapiramidali, ipokajniżja, irrekietezza, iperattività psikomotriċi, riġidità muskolari, diskajniżja) ma qabżux 4.1% fl-ebda grupp.
English: • treatment of Schizophrenia, including o preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR.
Maltese: • Skizofrenija, inkluż o biex jiġi evitat li pazjenti bi skizofrenija stabbli li kienu inżammu fuq Seroquel XR jirkadu
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs.
Maltese: Każijiet ta' tromoboemboliżmu fil-vini (VTE) kienu rrappurtati b'mediċini antipsikotiċi.
English: (11) Triglycerides ≥200 mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L) (patients <18 years of age) on at least one occasion (12) Cholesterol ≥240 mg/dL (≥6.2064 mmol/L) (patients ≥18 years of age) or ≥200 mg/dL (≥5.172 mmol/L) (patients <18 years of age) on at least one occasion.
Maltese: (11) Trigliċeridi ≥200 mg/dL (≥2.258 mmol/L) (pazjenti ≥18-il sena) jew ≥150 mg/dL (≥1.694 mmol/L) (pazjenti <18-il sena) f'mill-anqas okkażjoni waħda.
English: Elevations in gamma-GT levels3, Platelet count decreased14, QT prolongation 1,13, 19
Maltese: Żiediet fil-livelli ta' gamma-GT3, Tnaqqis fl-għadd tal-plejtlets14, Titwil tal-QT
English: Steadystate peak molar concentrations of the active metabolite norquetiapine are 35% of that observed for quetiapine.
Maltese: Konċentrazzjonijiet molari fl-istat fiss tal-metabolu attiv norquetiapine huma 35% ta' dak li jidher għal quetiapine.
English: The average molar dose fraction of free quetiapine and the active human plasma metabolite norquetiapine is <5% excreted in the urine.
Maltese: Ilmedja tal-frazzjoni tad-doża molari ta' quetiapine ħieles u l-metabolu attiv uman fil-plażma norquetiapine hija eskretata <5% fl-awrina.
English: Erythromycin or clarithromycin (for infections).
Maltese: - erythromycin jew clarithromycin (għall-infezzjonijiet) - nefazodone (għad-depressjoni)
English: (13) See text below (14) Platelets ≤100 x 109/L on at least one occasion (15) Based on clinical trial adverse event reports of blood creatine phosphokinase increase not associated with neuroleptic malignant syndrome (16) Prolactin levels (patients >18 years of age): >20 μg/L (>869.56 pmol/L) males; >30 μg/L (>1304.34 pmol/L) females at any time.
Maltese: Ibbażat fuq rapporti ta' każijiet avversi fi prova klinika ta' żieda tal-creatine phosphokinase fiddemm mhux assoċjata ma' sindrome newrolettika malinna (16) Livelli tal-prolaktin (pazjenti >18-il sena): >20 μg/L (>869.56 pmol/L) irġiel; >30 μg/L (>1304.34 pmol/L) nisa f'kull ħin.
English: As with other antipsychotics, weight gain, syncope, neuroleptic malignant syndrome, leucopenia, neutropenia and peripheral oedema, have been associated with quetiapine.
Maltese: Bħal antipsikotiċi oħra, żieda fil-piż, sinkope, sindrome newrolettika malinna, lewkopenija, newtropenija u edema periferali, kienu assoċjati ma' quetiapine.
English: Weight should be monitored regularly.
Maltese: Il-piż għandu jiġi monitorat regolarment.
English: 6.5 Nature and contents of container Polychlorotrifluoroethylene and polyvinylchloride with aluminium blister
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Polychlorotrifluoroethylene u polyvinylchloride b'folji ta'l-aluminium
English: The frequencies of adverse events are ranked according to the following: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100, rare (≥1/10,000, <1/1000) and very rare (<1/10,000).
Maltese: <1/10), mhux komuni (≥1/1000, <1/100, rari (≥1/10,000, <1/1000) u rari ħafna (<1/10,000).
English: The elimination half lives of quetiapine and norquetiapine are approximately 7 and 12 hours, respectively.
Maltese: Il-half lives ta' l-eliminazzjoni ta' quetiapine u norquetiapine huma madwar 7 sigħat u 12-il siegħa, rispettivament.
English: Quetiapine data in combination with divalproex or lithium in acute moderate to severe manic episodes is limited; however, combination therapy was well tolerated (see section 4.8 and 5.1).
Maltese: Dejta b'quetiapine flimkien ma' divalproex jew lithium f'episodji akuti moderati għal severi manijakali hija limitata; madankollu, terapija kombinata kienet tollerata sew (ara sezzjoni 4.8 u 5.1).
English: Different dosing schedules exist for each indication.
Maltese: Skedi ta' dożaġġi differenti jeżistu għal kull indikazzjoni.
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 osservata ta' avvenimenti relatati mas-suwiċidju f' pazjenti adulti żgħar (iżgħar minn 25 sena) kienet ta' 2.1% (3/144) għal quetiapine u 1.3% (1/75) għal plaċebo.
English: In all clinical trials (placebocontrolled, open-label, active comparator; patients with a baseline neutrophil count ≥1.5 X 109/L), the incidence of at least one occurrence of neutrophil count <0.5 X 109/L was 0.21% in patients treated with quetiapine and 0% in placebo treated patients and the incidence ≥0.5 - <1.0 X 109/L was 0.75% in patients treated with quetiapine and 0.11% in placebo-treated patients.
Maltese: Fil-provi kliniċi kollha (kontrollati bil-plaċebo, open label, b'kumparatur attiv; pazjenti b' għadd tan-newtrofili ta' ≥1.5 X 109/L mal-linjabażi), il-frekwenza ta' mill-anqas każ wieħed fejn lgħadd tan-newtrofili kien <1.5 X 109/L kien 0.21% f'pazjenti ikkurati b'quetiapine u 0% f'pazjenti ikkurati bi plaċebo u l-frekwenza ta' każijiet ≥0.5 - <1.0 X 109/L kienet 0.75% f'pazjenti ikkurati b'quetiapine u 0.11% f'pazjenti ikkurati bi plaċebo.
English: In an interaction study in healthy volunteers, concomitant administration of quetiapine (dosage of 25 mg) with ketoconazole, a CYP3A4 inhibitor, caused a 5- to 8-fold increase in the AUC of quetiapine.
Maltese: Fi studju dwar interazzjoni fuq voluntiera b'saħħithom, l-għotja ta' quetiapine (doża ta' 25 mg) flimkien ma' ketoconazole, impeditur ta' CYP3A4, ikkawża żieda ta' 5sa 8-darbiet fl-AUC ta' quetiapine.
English: (6) Calculation of Frequency for these ADR's have only been taken from postmarketing data with the immediate release formulation of Seroquel (7) Fasting blood glucose ≥126mg/dL(≥7.0 mmol/L) or a non fasting blood glucose ≥200mg/dL (≥11.1 mmol/L) on at least one occasion (8) An increase in the rate of dysphagia with quetiapine vs. placebo was only observed in the clinical trials in bipolar depression (9) Based on >7% increase in body weight from baseline.
Maltese: (6) Il-kalkolu tal-frekwenza għal dawn ittieħdet biss mid-dejta ta' wara t-tqegħid fis-suq bilformulazzjoni ta' Seroquel li terħi l-mediċina f'daqqa (7) Glucose fid-demm waqt is-sawm ≥126mg/dL(≥7.0 mmol/L) jew glucose fid-demm mhux waqt issawm ≥200mg/dL (≥11.1 mmol/L) f'mill-anqas okkażjoni waħda (8) Żieda fir-rata ta' disfaġja b'quetiapine vs plaċebo kien osservat biss fil-provi kliniċi b'depressjoni bipolari (9) Ibbażat fuq >7% żieda fil-piż tal-ġisem mil-linja bażi.
English: Rhinitis
Maltese: PAJJIŻ
English: Increases in triglycerides, LDL and total cholesterol, and decreases in HDL cholesterol have been observed in clinical trials with quetiapine (see section 4.8).
Maltese: Żiediet tat-trigliċeridi, LDL u kolesterol totali, u tnaqqis fil-kolesterol HDL dehru fil-provi kliniċi bi quetiapine (ara sezzjoni 48).
English: The incidence of relapse was 14.2% for Seroquel XR treated patients and 34.4% for placebotreated patients.
Maltese: Il-frekwenza ta' dawk li rkadew kienet 14.2% għall-pazjenti kkurati b'Seroquel XR u 34.4% għall-pazjenti kkurati bi plaċebo.
English: Marketing Authorisation Holder and Manufacturer <[To be completed nationally]> {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq u l-Manifattur: [ Biex timtela mill-pajjiż partikolari] {Isem u indirizz ral-manifattur}
English: Constipation, dyspepsia
Maltese: Stitikezza, dispepsja
English: In the schizophrenia study, the difference in LS mean change from baseline in PANSS total score (active minus placebo) was -8.16 for Seroquel 400 mg/day and -9.29 for Seroquel 800 mg/day .
Maltese: Fl-istudju fuq skizofrenija, id-differenza fil-medja tal-bidla LS mill-linja bażi fil-punteġġ totali PANSS (attiv jitnaqqas minnu l-plaċebo) kienet -8.16 għal Seroquel 400 mg/jum u -9.29 għal Seroquel 800 mg/jum.
English: LULuxembourg
Maltese: Albertslund
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, kontrollati bi plaċebo fi skizofrenija u manija bipolari, il-frekwenza kollettiva tas-sintomi ekstrapiramidali kienet simili għal plaċebo (skizofrenija: 7.8% għal quetiapine u 8.0% għal plaċebo; manija bipolari:
English: ¾ General Practice Research Database (GPRD) Study;
Maltese: ¾ Studju dwar il-Monitoraġġ tal-Avvenimenti ta' Riċetta Mibdula (Modified Prescription Event Monitoring - M-PEM); ¾ Studju dwar id-Database ta' Riċerka tal-Prattika Ġenerali (General Practice Research Database - GPRD);
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 ma' divalproex jew lithium f'episodji akuti moderati għal manijakali severi f'ġimgħat 3 u 6 hija limitata; iżda, terapija kombinata kienet tollerata sew.
English: In clinical trials, no additional benefit was seen in the 600 mg group compared to the 300 mg group (see section 5.1).
Maltese: Fi provi kliniċi, ma deherx li kien hemm aktar benefiċċju fil-grupp fuq 600 mg meta mqabbel mal-grupp fuq 300 mg (ara sezzjoni 5.1).
English: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel
Maltese: NV AstraZeneca SA Egide Van Ophemstraat 110
English: Metabolism and nutritional disorders Common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni:
English: In shorter-term placebo controlled clinical studies of patients with major depressive episodes in bipolar disorder an increased risk of suicide-related events was observed in young adults patients (younger than 25 years of age) who were treated with quetiapine as compared to those treated with placebo (3.0% vs. 0%, respectively).
Maltese: Fi studji kliniċi qosra u kkontrollati bi plaċebo ta' pazjenti b' episodji ta' depressjoni kbira f' disturb bipolari, kienu osservati żieda fir-riskju ta' avvenimenti relatati mas-suwiċidju f' pazjenti adulti żghar (iżgħar minn 25 sena) li kienu kkurati b' quetiapine meta mqabbla ma dawk ikkurati bi plaċebo (3.0% vs. 0% rispettivament).
English: The estimated risks of relapse after 6 months treatments was 14.3% for the Seroquel XR treatment group compared to 68.2% for placebo.
Maltese: Ir-riskji li jirkadu stmati wara 6 xhur ta' kura kienu 14.3% għal grupp ta' kura b'Seroquel XR imqabbla ma' 68.2% għall-plaċebo.
English: Children and adolescents (10 to 17 years of age) Pharmacokinetic data were sampled in 9 children aged 10-12 years old and 12 adolescents, who were on steady-state treatment with 400 mg quetiapine (Seroquel) twice daily.
Maltese: Dejta farmakokinetika ittieħdet bħala kampjun f'9 itfal ta' etajiet bejn 10-12-il sena u 12-il adolexxenti, li kienu fuq kura fi stat fiss b'400 mg quetiapine (Seroquel) darbtejn kuljum.
English: Seroquel XR tablets contain 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
Maltese: Il-pilloli Seroquel XR fihom 50 mg, 150 mg, 200 mg, 300 mg jew 400 mg ta' quetiapine (bħala quetiapine fumarate)
English: AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands
Maltese: 2719 EE Zoetermeer The Netherlands
English: Fatal outcome has been reported in clinical trials following an acute overdose at 13.6 grams, and in post-marketing on doses as low as 6 grams of Seroquel alone.
Maltese: Kien hemm każ ta' mewt waqt prova klinika b'doża eċċessiva akuta ta' 13.6 grammi, u wara t-tqegħid fis-suq b'dożi baxxi sa 6 grammi b'Seroquel waħdu.
English: Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported with the use of neuroleptics and are considered class effects.
Maltese: Każijiet ta' titwil tal-QT, arritmija ventrikulari, mewt f'daqqa mingħajr spjegazzjoni, arrest kardijaku u torsades de pointes kienu rrappurtati bl-użu ta' newrolettiċi u huma meqjusa effetti tal-klassi.
English: Seroquel XR 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets quetiapine
Maltese: Seroquel XR 50 mg, 150 mg, 200 mg, 300 mg, 400 mg pilloli li jerħu l-mediċina bil-mod quetiapine
English: • Swelling of breasts and unexpected production of breast milk (galactorrhoea).
Maltese: • Tneffiħ tas-sider u produzzjoni mhux aspettata ta' ħalib tas-sider (galaktorreja)
English: • Feeling irritated
Maltese: • Irritablita
English: From animal studies it appears that quetiapine can induce cytochrome P450 enzymes.
Maltese: Minn studji fuq l-annimali jidher li quetiapine jista' jinduċi enzimi ta' cytochrome P450.
English: In short-term clinical trials with Seroquel in paediatric patients (10-17 years of age), 17% of quetiapine treated patients and 2.5% of placebo treated patients gained ≥7% of their body weight.
Maltese: Fi provi fuq żmien qasir b'Seroquel f'pazjenti pedjatriċi (10-17-il sena), 17% tal-pazjenti ikkurati b'quetiapine u 2.5% tal-pazjenti ikkurati bi plaċebo żdiedu b'≥7% tal-piż ta' ġisimhom.
English: Quetiapine should be discontinued in patients with a neutrophil count <1.0 X 109/L.
Maltese: Quetiapine għandu jitwaqqaf f'pazjenti li jkollhom għadd tan-newtrofili <1.0 X 109/L.
English: In a short-term placebo-controlled monotherapy trial with Seroquel in children and adolescent patients (10-17 years of age) with bipolar mania, the aggregated incidence of extrapyramidal symptoms was 3.6% for quetiapine and 1.1% for placebo.
Maltese: Fi prova b'monoterapija ikkontrollata bi plaċebo fuq żmien qasir b'Seroquel f'pazjenti tfalu adolexxenti (10-17-il sena) b'manija bipolari, il-frekwenza kollettiva ta' sintomi ekstrapiramidali kienet 3.6% għal quetiapine u 1.1% għall-paċebo.
English: In the mania study, the difference in LS mean change from baseline in YMRS total score (active minus placebo) was -5.21 for Seroquel 400 mg/day and -6.56 for Seroquel 600 mg/day.
Maltese: Fl-istudju fuq manija, id-differenza fil-medja tal-bidla LS mil-linja bażi fil-punteġġ totali YMRS (attiv jitnaqqas minnu l-plaċebo) kienet -5.21 għal Seroquel 400 mg/jum u -6.56 għal Seroquel 600 mg/jum.
English: Tardive Dyskinesia:
Maltese: Rari ħafna:
English: Extrapyramidal Symptoms
Maltese: Sintomi Ekstrapiramidali
English: When Seroquel XR is compared to Seroquel immediate release, the norquetiapine metabolite AUC is 18% lower.
Maltese: Meta Seroquel XR jitqabbel ma' Seroquel li jintreħa f'daqqa, l-AUC tal-metabolu norquetiapine hija 18% aktar baxxa.
English: Quetiapine was administered twice-daily totalling 400 mg to 800 mg a day as combination therapy to lithium or valproate.
Maltese: Quetiapine ingħata darbtejn kuljum b'totali ta' 400 mg sa 800 mg kull jum bħala terapija kombinata ma' lithium jew valproate.
English: - The CHMP concluded on a positive benefit risk ratio for Seroquel XR as add-on treatment of major depressive episodes in patients with major depressive disorder, who have had suboptimal response to initial antidepressant monotherapy further to consideration of the safety profile of Seroquel.
Maltese: - Is-CHMP ikkonkluda fuq proporzjon ta' benefiċċju riskju pożittiv għal Seroquel XR bħala trattament addizzjonali ta' episodji depressivi maġġuri f'pazjenti b'disturb depressiv maġġuri, li ma kellhomx rispons tajjeb biżżejjed għall-monoterapija inizjali bl-antidepressanti wara lkonsiderazzjoni tal-profil ta' sigurtà ta' Seroquel.
English: Seroquel (quetiapine fumarate), prolonged release tablets (XR) at strength of 50 mg, 150 mg, 200 mg, 300 mg and 400 mg is authorised in the European Union via the Mutual Recognition and Decentralised procedures for the following indications:
Maltese: Seroquel (quetiapine fumarate), pilloli b'rilaxx imtawwal (XR) f'qawwa ta' 50 mg, 150 mg, 200 mg, 300 mg u 400 mg huwa awtorizzat fl-Unjoni Ewropea permezz tal-proċeduri ta' Rikonoxximent Reċiproku u Deċentralizzati għall-indikazzjonijiet li ġejjin:
English: In the treatment of moderate to severe manic episodes, Seroquel demonstrated superior efficacy to placebo in reduction of manic symptoms at 3 and 12 weeks, in two monotherapy trials.
Maltese: Fil-kura ta' episodji manijakali moderati għal severi, Seroquel wera li kellu effikaċja superjuri għal plaċebo fit-tnaqqis tas-sintomi manijakali f'ġimgħat 3 u 12, f'żewġ provi b'monoterapija.
English: Mean change among patients who had this increase was 41.7 mg/dL ( 1.07 mmol/L).
Maltese: Bidla medja fost il-pazjenti li kellhom din iż-żieda kienet 41.7 mg/dL ( 1.07 mmol/L).
English: Elevations in total cholesterol (predominantly LDL cholesterol) 12, Decreases in HDL cholesterol18, Weight gain9
Maltese: Żiediet fil-livelli tat-trigliċeridi fis-serum Żiediet tal-kolesterol totali (l-aktar kolesterol LDL) 12, Tnaqqis fil-kolesterol HDL18, Żieda fil-piż9
English: Quetiapine is an atypical antipsychotic agent, which together with its active metabolite - norquetiapine interacts with several neurotransmitter receptors.
Maltese: Quetiapine huwa sustanza antipsikotika atipika, li flimkien mal-metabolit attiv tagħha - norquetiapine jaġixxi ma' bosta rIċetturi newrotrasmettituri.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Maltese: F'pazjenti li jiżviluppaw dawn is-sintomi, żieda fid-doża tista' tkun ta' detriment.
English: Pharmacotherapeutic group: Antipsychotics; Diazepines, oxazepines and thiazepines ATC code: N05A H04
Maltese: Antipsikotiċi, diażepini, oxażepini u tijażepini Kodiċi ATC:
English: In short-term, placebo-controlled monotherapy clinical trials in major depressive disorder the aggregated incidence of extrapyramidal symptoms was 5.4% for Seroquel XR and 3.2% for placebo.
Maltese: Fi provi kliniċi fuq żmien qasir, b'monoterapija kkontrollati bi plaċebo f'disturb depressiv kbir ilfrekwenza kollettiva tas-sintomi ekstrapiramidali kienet 5.4% għal Seroquel XR u 3.2% għall-plaċebo.
English: The daily dose at the start of therapy is 50 mg on Day 1 and 2, and 150 mg on Day 3 and 4.
Maltese: Id-doża ta' kuljum fil-bidu tat-terapija hija 50 mg f'Jum 1 u 2, u 150 mg f'Jum 3 u 4.
English: Other than the incidence of extrapyramidal symptoms (see section 4.8 and ‘Clinical Safety' below) the tolerability of Seroquel XR once daily in elderly patients was comparable to that seen in adults (aged 18-65 years).
Maltese: Minbarra l-frekwenza tas-sintomi ekstrapiramidali (ara sezzjoni 4.8 u ‘Sigurtà Klinika' hawn taħt) it-tolerabilità ta' Seroquel XR darba kuljum f'pazjenti anzjani kienet kumparabbli ma' dik li dehret fl-adulti (età 18-65 sena).
English: The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily.
Maltese: Id-doża ta' kuljum rakkomandata hija 600 mg kuljum, iżda jekk ikun hemm ġustifikazzjoni klinika id-doża tista' tiżdied għal 800 mg kuljum.
English: 10 blisters of 5 tablets
Maltese: 10 folji ta'5 pilloli
English: A meta analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Maltese: Analiżi meta ta' provi ikkontrollati bi plaċebo ta' mediċini kontra d-depressjoni f'pazjenti adulti b'disturbi psikjatriċi wrew żieda fir-riskju ta' mġieba ta' suwiċidju b'mediċini kontra d-depressjoni meta mqabbla mal-plaċebo f'pazjenti taħt il-25 sena.
English: The CHMP, based on the data available and further to consultation of the clinical neuroscience scientific advisory group (SAG-CNS), considered that efficacy in the therapeutic indication applied by the MAH, i.e., monotherapy in patients with recurrent major depression episodes that cannot be appropriately managed with alternative antidepressants, was not explicitly studied in the performed studies.
Maltese: Is-CHMP, abbażi tad-dejta disponibbli u wara konsultazzjoni mal-grupp ta' konsulenza xjentifika dwar in-newroxjenza klinika (SAG-CNS), ikkunsidra li l-effikaċja fl-indikazzjoni terapewtika applikata mill-MAH, jiġifieri, monoterapija f'pazjenti b'episodji rikorrenti ta' depressjoni maġġuri li ma jistgħux jiġu kkontrollati kif xieraq permezz ta' antidepressanti alternattivi, ma ġietx studjata b'mod espliċitu fl-istudji mwettqa.
English: Tablet Strength
Maltese: Żieda fil-Piż
English: In short-term placebo-controlled trials with Seroquel in paediatric patients with bipolar mania, the incidence of suicide related events was 1.0% (2/193) for quetiapine and 0% (0/90) for placebo in patients <18 years of age.
Maltese: Fi provi ikkontrollati bi plaċebo b'Seroquel f'pazjenti pedjatriċi b'manija bipolari, il-frekwenza ta' każijiet relatati mas-suwiċidju kienet 1.0% (2/193) għal quetiapine u 0% (0/90) għall-pazjenti fuq plaċebo f'pazjenti <18-il sena.
English: • Women to have no monthly period or irregular periods.
Maltese: • Bniet li ma jkollhomx mestrwazzjoni fix-xaħar jew mestrwazzjoni irregolari.
English: It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. sodium valproate) (see section 4.4).
Maltese: Huwa importanti li kull bidla fl-induttur tkun gradwali, u jekk ikun meħtieġ, jiġi mibdul b'wieħed li ma jkunx induttur (eż. sodium valproate) (ara sezzjoni 4.4).
English: Quetiapine and norquetiapine also have high affinity at histaminergic and adrenergic α1 receptors, with a lower affinity at adrenergic α2- and serotonin 5HT1A receptors.
Maltese: Quetiapine u norquetiapine għandhom ukoll affinità għolja għar-riċetturi istaminerġiċi u adrenerġiċi α1, b'affinità aktar baxxa għar-riċetturi adrenerġiċi α2- u serotonin 5HT1A.
English: • treatment of bipolar disorder : o For the treatment of moderate to severe manic episodes in bipolar disorder o For the treatment of major depressive episodes in bipolar disorder o For the prevention of recurrence in patients with bipolar disorder, in patients whose manic or depressive episode has responded to quetiapine treatment .
Maltese: • prevenzjoni ta' rikorrenza f'pazjenti b'disturbi bipolari, f'pazjenti li l-episodju manijaku jew depressiv tagħhom kellu rispons għat-trattament bi quetiapine.