FrancophonIA/ELRC3.0 huggingface dataset:
English: • Increased blood creatine phosphokinase (a substance from the muscles
Maltese: • Żieda fil-creatine phosphokinase fid-demm (sustanza mill-muskoli)
English: • Changes in the amount of certain fats (triglycerides and total cholesterol)
Maltese: • Tibdiliet fl-ammont ta' ċerti xaħmijiet (trigliċeridi u kolesterol totali)
English: When Seroquel XR is compared to Seroquel immediate release, the norquetiapine metabolite AUC is 18% lower.
Maltese: Meta Seroquel XR jiġi mqabbel ma' Seroquel b'rilaxx f'daqqa, l-AUC tal-metabolit norquetiapine huwa ta' 18% aktar baxx .
English: Quetiapine is an atypical antipsychotic agent.
Maltese: Quetiapine huwa aġent antipsikotiku atipiku.
English: (See section 4.4, Orthostatic hypotension ).
Maltese: .4, Pressjoni Baxxa Ortostatika).
English: Elevations in serum aspartate aminotransferas e (AST)
Maltese: Żidiet fl aspartate aminotransferas e fis-serum (AST)
English: Overdose could lead to QT-prolongation, seizures, status epilepticus, rhabdomyolysis, respiratory depression, urinary retention, confusion, delirium and/or agitation, coma and death.
Maltese: Doża eċċessiva tista' twassal għal titwil tal-QT, aċċessjonijiet, status epilepticus, rabdomajoliżi, dipressjoni respiratorja, żamma tal-awrina, konfużjoni, delirju u/jew aġitazzjoni, koma u mewt.
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 ta' interazzjoni fuq voluntiera b'saħħithom, l-għoti ta' quetiapine (doża ta' 25 mg) flimkien ma' ketoconazole, inibitur ta' CYP3A4, ikkawża żieda ta' 5-sa 8-darbiet fl-AUC ta' quetiapine.
English: An increase in LDL cholesterol of ≥30 mg/dL (≥0.769 mmol/L) has been very commonly observed.
Maltese: Żieda fil-kolesterol LDL ta' ≥30 mg/dL (≥0.769 mmol/L)
English: For 150 mg and 300 mg tablets pack sizes of 120, 180 and 240 tablets are registered.
Maltese: Għal pilloli ta' 150 mg u 300 mg , huma rreġistrati daqsijiet ta' pakkett ta' 120, 180 u 240 pillola.
English: For 100 mg, 150 mg, 200 mg and 300 mg tablets pack sizes of 10, 90 are registered.
Maltese: Għal pilloli ta' 100 mg, 150 mg, 200 mg u pilloli 300 mg huma rreġistrati daqsijiet ta' pakkett ta' 10, 90.
English: • Be careful how much alcohol you drink.
Maltese: • Oqgħod attent kemm tixrob alkoħol.
English: Prolactin levels (patients < 18 years of age): >20 ug/L (>869.56 pmol/L) males; >26 ug/L (>1130.428 pmol/L) females at any time.
Maltese: Livelli tal-prolactin (pazjenti < 18-il sena): >20 ug/L (>869.56 pmol/L) irġiel; >26 ug/L (>1130.428 pmol/L)
English: • Change in electrical activity of the heart seen on ECG (QT prolongation)
Maltese: • Bidla fl-attività elettrika tal-qalb li tidher fuq ECG (titwil tal-QT)
English: This risk persists until significant remission occurs.
Maltese: Dan ir-riskju jippersisti sakemm ikun hemm remissjoni sinifikanti.
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 1865 years).
Maltese: Minbarra l-inċidenza ta' sintomi ekstrapiramidali (ara sezzjoni 4.8 u ‘Sigurtà Klinika' hawn taħt) it tollerabilità ta' Seroquel XR darba kuljum f'pazjenti anzjani kienet komparabbli għal dik li dehret fl adulti (età minn 18-65 sena).
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), very rare (<1/10,000), and not known
Maltese: Komuni ħafna (≥1/10), komuni (≥1/100, <1/10), mhux komuni (≥1/1000, <1/100, rari (≥1/10,000, <1/1000), rari ħafna (<1/10,000), u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Tablet core : povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate Type A, lactose monohydrate, magnesium stearate Tablet coating: hypromellose, macrogol, titanium dioxide (E171).
Maltese: Qalba tal-pillola: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate Tip A, lactose monohydrate, magnesium stearate, hypromellose.
English: Elevations in serum alanine aminotransferas e (ALT)
Maltese: Żidiet fl-alanine aminotransferas e fis-serum (ALT)
English: Seroquel® 25 mg Filmtabletten, Seroquel® 100 mg Filmtabletten,
Maltese: Seroquel® 25 mg Filmtabletten, Seroquel® 100 mg Filmtabletten, Seroquel® 200 mg
English: Frequency based on adverse event reports of bradycardia and related events in all clinical trials with quetiapine.
Maltese: Il-frekwenza hija bbażata fuq rapporti ta' avvenimenti avversi ta' bradikardija u avvenimenti relatati fil-provi kliniċi kollha bi quetiapine.
English: The average dose was 669 mg.
Maltese: Id-doża medja kienet ta' 669 mg.
English: Iron oxide, yellow (E172) (50, 200 and 300 mg tablets) Iron oxide, red (E172) (50 mg tablets) 6.2 Incompatibilities
Maltese: Iron oxide, yellow (E172) (pilloli ta' 50, 200 u 300 mg) Iron oxide, red (E172) (pilloli ta' 50 mg)
English: INFORMATION IN BRAILLE Seroquel 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Seroquel 25 mg
English: In the short-term pediatric trials with quetiapine described above, the rates of EPS in the active arm vs. placebo were 12.9% vs. 5.3% in the schizophrenia trial, 3.6% vs. 1.1% in the bipolar mania trial, and 1.1%
Maltese: Fil-provi pedjatriċi fuq żmien qasir bi quetiapine deskritti hawn fuq, ir-rati ta' EPS fil-fergħa attiva kontra plaċebo kienu ta' 12.9% kontra 5.3% fil-prova ta' skizofrenija, 3.6% kontra 1.1% fil-prova ta' manija bipolari, u ta' 1.1% kontra 0% fil-prova ta' dipressjoni bipolari.
English: The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine (≥10%) are somnolence, dizziness, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
Maltese: L-aktar Reazzjonijiet Avversi tal-Mediċina (ADRs) irrapportati b'mod komuni bi quetiapine (≥10%) huma ngħas, sturdament, uġigħ ta' ras, ħalq xott, sintomi ta' irtirar (twaqqif), żidiet fil-livelli tat trigliċeridi fis-serum, żidiet fil-kolesterol totali (l-aktar kolesterol LDL), tnaqqis fil-kolesterol HDL, żieda fil-piż, tnaqqis fl-emoglobina u sintomi ekstrapiramidali.
English: Dysphagia
Maltese: Dispnea
English: Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase.
Maltese: L-inċidenza ta' pazjenti li għandhom bidla fil-QTc minn <450 msec għal ≥450 msec b'żieda ta' ≥30 msec.
English: Metabolism and nutritional disorders
Maltese: Disturbi fil-metaboliżmu u n nutrizzjoni
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs.
Maltese: Każijiet ta' tromoboemboliżmu fil-vini (VTE) kienu rrapportati b'mediċini antipsikotiċi.
English: Antidepressant effect was seen at 150 and 300 mg/day in shortterm trials as add-on therapy (with amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline and venlafaxine - see Section 5.1) and at 50 mg/day in short-term monotherapy trials.
Maltese: Fi provi fuq żmien qasir l-effett kontra d-dipressjoni deher b'150 u 300 mg/kuljum bħala terapija miżjuda (ma' amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline u venlafaxine - ara Sezzjoni 5.1) u b'50 mg/kuljum fi provi qosra ta' monoterapija.
English: However in two 10-week placebocontrolled quetiapine studies in the same patient population (n=710); mean age: 83 years; range: 56-99 years) the incidence of mortality in quetiapine treated patients was 5.5% versus 3.2% in the placebo group.
Maltese: Madankollu, f'żewġ studji ta'10 ġimgħat ikkontrollati bi plaċebo ta' quetiapine fl-istess popolazzjoni ta' pazjenti (n=710; età medja: 83 sena; medda: 56-99 sena) l-inċidenza ta' mortalità f'pazjenti li kienu qed jingħataw kura bi quetiapine kienet ta' 5.5% kontra 3.2% fil-grupp tal-plaċebo.
English: Priapism, galactorrhoea, breast swelling, menstrual disorder
Maltese: Prijapiżmu, galaktorreja, nefħa fis-sider, disturb mestrwali
English: The elimination half lives of quetiapine and norquetiapine are approximately 7 and 12 hours, respectively.
Maltese: Il-half lives tal-eliminazzjoni ta' quetiapine u norquetiapine huma ta' madwar 7 u 12-il siegħa, rispettivament.
English: The proportion of randomized patients over 75 years of age was 19%.
Maltese: Il-proporzjon ta' pazjenti randomizzati li kellhom aktar minn 75 sena kien ta' 19%.
English: • treatment of bipolar disorder:
Maltese: • kura ta' Skizofrenija • kura ta' disturb bipolari:
English: 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' rtirar li ġejjin kienu osservati l-aktar frekwenti fi provi kliniċi akuti kkontrollati bi plaċebo b'monoterapija, li vvalutaw is-sintomi ta' twaqqif: insomnja, dardir, uġigħ ta' ras, dijarea, rimettar, sturdament, u irritabilità.
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-bidla medja fl-LS mil-linja bażi fil-punteġġ totali fuq PANSS (attiv li minnu tnaqqas il-plaċebo) kienet ta' -8.16 għal Seroquel 400 mg/kuljum u ta' -9.29 għal Seroquel 800 mg/kuljum.
English: Elevations in total cholesterol (predominantly LDL cholesterol) Decreases in HDL cholesterol 17,30,
Maltese: Żidiet fil kolesterol totali (l-aktar kolesterol LDL)
English: Day 4 morning evening 25 mg 2x25 mg 100 mg 200 mg
Maltese: 25 mg 2x25 mg 100 mg 200 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 3-Day starter pack
Maltese: KARTUNA Pakkett tal-Bidu ta' 3 ijiem
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: Id-dejta dwar quetiapine f'kombinazzjoni ma' divalproex jew lithium f'episodji manijaċi akuti moderati għal severi hija limitata; madankollu, it-terapija kkombinata kienet ittollerata sew (ara sezzjoni 4.8 u 5.1).
English: Table 2 ADRs in children and adolescents associated with quetiapine therapy that occur in a higher frequency than adults, or not identified in the adult population
Maltese: Tabella 2 ADRs fi tfal u adolexxenti assoċjati ma' terapija bi quetiapine li jseħħu bi frekwenza ogħla milli fl-adulti, jew li ma ġewx identifikati fil-popolazzjoni adulta
English: Seroquel contains a substance called quetiapine.
Maltese: Seroquel fih sustanza msejħa quetiapine.
English: Constipation and intestinal obstruction
Maltese: Stitikezza u ostruzzjoni intestinali
English: For add-on treatment of major depressive episodes in MDD:
Maltese: Għal kura miżjuda ta' episodji depressivi maġġuri f'MDD:
English: Based on public literature, patients with delerium and agitation and a clear anticholinergic syndrome may be treated with physostigmine, 1-2 mg (under continuous ECG monitoring).
Maltese: Abbażi tal-letteratura pubblika, pazjenti b'delirju u aġitazzjoni u sindromu antikolinerġiku ċar jistgħu jiġu ttrattati b'physostigmine, 1-2 mg (taħt monitoraġġ kontinwu b'ECG).
English: Day 3 morning evening 25 mg 2x25 mg 100 mg
Maltese: 25 mg 2x25 mg 100 mg
English: Respiratory, thoracic and mediastinal disorder
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Seroquel with food, drink and alcohol
Maltese: Seroquel ma' ikel, xorb u alkoħol
English: Shifts in eosinophils are defined as >1x 10^9 cells/L at any time.
Maltese: Tibdil fl-esinofili huwa definit bħala >1x 10^9 ċelloli/L fi kwalunkwe ħin.
English: The mean dose of Seroquel XR during the randomised phase was 177 mg/day.
Maltese: Seroquel XR kienet ta' 177 mg/kuljum.
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 manijaċi moderati għal severi, Seroquel wera effikaċja superjuri għal plaċebo fittnaqqis tas-sintomi manijaċi fil-ġimgħat 3 u 12, f'żewġ provi b'monoterapija.
English: 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: Kolesterol ≥240 mg/dL (≥6.2064 mmol/L) (pazjenti ≥18-il sena) jew ≥200 mg/dL (≥5.172 mmol/L) (pazjenti <18-il sena) f'mill-anqas okkażjoni waħda.
English: 24 blisters of 10 tablets (150 mg and 300 mg tablets only)
Maltese: 24 folja ta' 10 pilloli (150 mg u 300 mg pillola biss)
English: Hepatic Impairment
Maltese: Disfunzjoni sesswali
English: 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 16.
Maltese: Livelli tal-prolactin (pazjenti >18-il sena): >20 μg/L (>869.56 pmol/L) irġiel; >30 μg/L (>1304.34 pmol/L) nisa fi kwalunkwe ħin. 16.
English: Note: The frequency is consistent to that observed in adults, but might be associated with different clinical implications in children and adolescents as compared to adults.
Maltese: Nota: Il-frekwenza hija konsistenti ma' dik osservata fl-adulti, iżda tista' tkun assoċjata ma' implikazzjonijiet kliniċi differenti fit-tfal u l-adolexxenti meta mqabbla mal-adulti.
English: • Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
Maltese: • Manija: fejn tista' tħossok eċitat ħafna, elat, agitat, entużjast jew iperattiv jew ikollok ġudizzju fqir inkluż li tkun aggressiv jew tkun ta' tfixkil.
English: Responder rates (YMRS improvement ≥50%) were 64% for Seroquel 400 mg/day, 58% for 600 mg/day and 37% in the placebo arm.
Maltese: Seroquel 400 mg/kuljum, ta' 58% għal 600 mg/kuljum u ta' 37% fil-fergħa tal-plaċebo .
English: • Inflammation of the liver (hepatitis).
Maltese: • Infjammazzjoni tal-fwied (epatite).
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 skont l-SPC, quetiapine ma kienx assoċjat ma' żieda persistenti fl intervalli assoluti tal-QT.
English: Approximately 73% of the radioactivity is excreted in the urine and 21% in the faeces.
Maltese: Madwar 73% tar-radjuattività tiġi eliminata fl-awrina u 21% fl-ippurgar.
English: Severe neutropenia (neutrophil count <0.5 X 109/L) has been reported in quetiapine clinical trials.
Maltese: Fi provi kliniċi bi quetiapine newtropenja severa (għadd tan-newtrofili <0.5 X 109/L) kienet irrapportata.
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 fuq żmien qasir ikkontrollati bi plaċebo ta' pazjenti b'episodji depressivi maġġuri f'disturb bipolari kienet osservata żieda fir-riskju ta' avvenimenti relatati mas-suwiċidju f'pazjenti adulti żgħar (ta' anqas minn 25 sena) li kienu qed jirċievu kura bi quetiapine meta mqabbla ma' dawk li kienu qed jirċievu kura bi plaċebo (3.0% kontra 0%, rispettivament).
English: 50 mg, 150 mg 200 mg, 300 mg and 400 mg tablets
Maltese: Pilloli ta' 50 mg, 150 mg 200 mg, 300 mg u 400 mg
English: The number of patients with a mood event was 91 (22.5%) in the quetiapine group, 208 (51.5%) in the placebo group and 95 (26.1%) in the lithium treatment groups respectively.
Maltese: L-għadd ta' pazjenti li kellhom avveniment relatat mal burdata kien ta' 91 (22.5%) fil-grupp fuq quetiapine, ta' 208 (51.5%) fil-grupp fuq plaċebo u ta' 95
English: Weight should be monitored regularly.
Maltese: Il-piż għandu jiġi mmonitorjat b'mod regolari .
English: Constipation represents a risk factor for intestinal obstruction.
Maltese: L-istitikezza tirrappreżenta fattur ta' riskju għal ostruzzjoni intestinali.
English: 120 film-coated tablets (150 mg and 300 mg tablets only) 180 film-coated tablets (150 mg and 300 mg tablets only) 240 film-coated tablets (150 mg and 300 mg tablets only)
Maltese: 120 pillola miksijin b'rita (pilloli ta'150 mg u 300 mg biss) 180 pillola miksijin b'rita (pilloli ta'150 mg u 300 mg biss) 240 pillola miksijin b'rita (pilloli ta'150 mg u 300 mg biss)
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 stmati ta' rikaduta wara 6 xhur ta' kura kienu ta' 14.3% għall-grupp ta' kura b'Seroquel XR meta mqabbla ma' 68.2% għall-plaċebo.
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 u kkontrollati bi plaċebo f'disturb depressiv maġġuri l-inċidenza aggregata ta' sintomi ekstrapiramidali kienet ta' 5.4% għal Seroquel XR u ta' 3.2% għal plaċebo.
English: Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din ilmediċina .
English: 18 blisters of 10 tablets (150 mg and 300 mg tablets only)
Maltese: 18-il folja ta' 10 pilloli (150 mg u 300 mg pillola biss)
English: Anaphylactic reaction5
Maltese: Reazzjoni anafilattika5
English: Epinephrine and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of quetiapine-induced alpha blockade.
Maltese: Epinephrine u dopamine għandhom jiġu evitati, peress li f'sitwazzjoni ta' imblokk alpha minħabba quetiapine stimulazzjoni beta tista' taggrava l-pressjoni baxxa.
English: Pharmacotherapeutic group: Antipsychotics; Diazepines, oxazepines and thiazepines ATC code: N05A H04
Maltese: Antipsikotiċi, Diażepini, oxażepini u tijażepini Kodiċi ATC:
English: Quetiapine should be discontinued in patients with a neutrophil count <1.0 X 109/L.
Maltese: Quetiapine għandu jitwaqqaf f'pazjenti b'għadd tan-newtrofili <1.0 X 109/L.
English: • Skin rash with irregular red spots (erythema multiforme)
Maltese: • Raxx tal-ġilda b'ponot ħomor u irregolari (eritema multiforme)
English: In a 6-week, randomised, study of lithium and SEROQUEL XR versus placebo and SEROQUEL XR in adult patients with acute mania, the difference in YMRS mean improvement between the lithium add-on group and the placebo add-on group was 2.8 points and the difference in % responders (defined as 50% improvement from baseline on the YMRS) was 11% (79% in the lithium add-on group vs. 68% in the placebo add-on group).
Maltese: f'pazjenti adulti b'manija akuta, id-differenza fit-titjib medju fuq YMRS bejn il-grupp li kellu lithium miżjud u l-grupp li kellu plaċebo miżjud kienet ta' 2.8 punti u d-differenza fil-% ta' dawk li rrispondew (definita bħala titjib ta' 50% mil-linja bażi fuq il-YMRS) kienet ta' 11% (79% fil-grupp li kellu lithium miżjud kontra 68% fil-grupp li kellu plaċebo miżjud).
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 t-tqegħid fis-suq, it-titwil tal-QT kien irrapportat bi quetiapine fid-dożi terapewtiċi (ara Sezzjoni 4.8) u f'doża eċċessiva (ara Sezzjoni 4.9).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 4-Day starter pack
Maltese: KARTUNA Pakkett ta' bidu ta' 4 ijiem
English: Shift from >132 mmol/L to ≤132 mmol/L on at least one occasion.
Maltese: Bidla minn >132 mmol/L għal ≤132 mmol/L f'mill-anqas okkażjoni waħda.
English: Based on shift in neutrophils from >=1.5 x 10^9/L at baseline to <0.5 x 10^9/L at any time during treatment and based on patients with severe neutropenia (<0.5 x 109/L) and infection during all quetiapine clinical trials (See Section 4.4).
Maltese: Abbażi ta' tibdil fin-newtrofili minn >=1.5 x 10^9/L fil-linja bażi għal <0.5 x 10^9/L fi kwalunkwe ħin matul ilkura u abbażi ta' pazjenti b'newtropenja severa (<0.5 x 109/L) u b'infezzjoni matul il-provi kliniċi kollha bi quetiapine (Ara Sezzjoni 4.4).
English: Decreased haemoglobin to ≤13 g/dL (8.07 mmol/L) males, ≤12 g/dL (7.45 mmol/L) females on at least one occasion occurred in 11% of quetiapine patients in all trials including open label extensions.
Maltese: Tnaqqis fl-emoglobina għal ≤13 g/dL (8.07 mmol/L) irġiel, ≤12 g/dL (7.45 mmol/L) nisa f'mill-anqas okkażjoni waħda seħħ fi 11% tal-pazjenti fuq quetiapine fil-provi kollha inkluż estensjonijiet b'tikketta miftuħa.
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: Meta-analiżi ta' provi kliniċi kkontrollati bi plaċebo ta' mediċini kontra d-dipressjoni f'pazjenti adulti b'disturbi psikjatriċi uriet riskju akbar ta' mġieba suwiċidali b'mediċini kontra d-dipressjoni meta mqabbla ma' plaċebo f'pazjenti taħt il-25 sena.
English: The efficacy of Seroquel XR in the treatment of schizophrenia was demonstrated in one 6-week placebocontrolled trial in patients who met DSM-IV criteria for schizophrenia, and one active-controlled Seroquel immediate release-to-Seroquel XR switching study in clinically stable outpatients with schizophrenia.
Maltese: L-effikaċja ta' Seroquel XR għall-kura ta' skizofrenija intweriet fi prova waħda ta' 6-ġimgħat ikkontrollata bi plaċebo f'pazjenti li ssodisfaw il-kriterji tad-DSM-IV għal skizofrenija, u studju wieħed attivament ikkontrollat ta' qlib minn Seroquel li jerħi l-mediċina f'daqqa għal Seroquel XR fuq pazjenti outpatients bi skizofrenija klinikament stabbli.
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'total ta' 400 mg sa 800 mg kuljum bħala terapija kkombinata ma' lithium jew valproate .
English: 6.5 Nature and contents of container PVC/aluminium blisters Pack sizes
Maltese: Folji tal-PVC/aluminju Daqsijiet tal-pakkett Folji:
English: Neuroleptic malignant syndrome hypothermia
Maltese: Sindromu newrolettiku malinn ipotermja
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 fuq żmien qasir (sa 8 ġimgħat) b'monoterapija, f'pazjenti b'disturb depressiv maġġuri, Seroquel XR 50 mg, 150 mg u 300 mg/kuljum wera effikaċja superjuri għall plaċebo fit-tnaqqis tas-sintomi depressivi kif imkejjel b'titjib fil-punteġġ totali fuq il-MontgomeryÅsberg Depression Rating Scale (MADRS) (bidla medja fl-LS kontra plaċebo ta' 2-4 punti).
English: Seroquel contains lactose
Maltese: Seroquel fih lactose
English: The incidence of relapse was 14.2% for Seroquel XR treated patients and 34.4% for placebo-treated patients.
Maltese: L-inċidenza ta' rikaduta kienet ta' 14.2% għall-pazjenti li kienu qed jirċievu kura b'Seroquel XR u ta' 34.4% għall-pazjenti li kienu qed jirċievu kura bi plaċebo.