FrancophonIA/ELRC3.0 huggingface dataset:
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Maltese: Manifestazzjoni ta' din iż-żieda fis-sensittività tista' tinkludi konfużjoni, nuqqas ta' ħila mentali, instabilità li tiddependi mill-qagħda b'waqgħat frekwenti, flimkien ma' sintomi extrapiramidali.
English: Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
Maltese: Sycrest hu indikat għall-kura ta' episodji manijaċi moderati sa severi assoċjati ma' disturb bipolari I f'persuni adulti.
English: In a 12-week, placebo-controlled trial involving 326 patients with a manic or mixed episode of bipolar I disorder, with or without psychotic features, who were partially non-responsive to lithium or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of asenapine as adjunctive therapy resulted in superior efficacy to lithium or valproate monotherapy at week 3 (point estimates [95 % CI] for the change from baseline to endpoint in YMRS using LOCF analysis were -10.3 [-11.9, -8.8] for asenapine and -7.9 [-9.4, -6.4] for placebo) and at week 12 (-12.7 [-14.5, -10.9] for asenapine and -9.3 [-11.8, -7.6] for placebo) in the reduction of manic symptoms.
Maltese: Fi prova li damet 12-il ġimgħa, ikkontrollata bi plaċebo, li kienet tinvolvi 326 pazjent b'episodju manijaku jew episodju mħallat ta' disturb bipolari I, bi jew mingħajr karatteristiċi psikotiċi, li ma rrispondewx parzjalment għal lithium jew valproate mogħtija waħidhom għal ġimagħtejn f'livelli terapewtiċi fis-serum, iż-żieda ta' asenapine bħala terapija addizzjonali, irriżultat f'effikaċja superjuri meta mqabbel ma' lithium jew valproate mogħtija waħidhom, wara ġimgħa 3 (stimi ta' punt [95 % CI] għal bidla mil-linja bażi sal-punt aħħari f'YMRS bl-użu ta' analiżi LOCF kienu -10.3 [-11.9, -8.8] għal asenapine u -7.
English: In the long-term extension trial (50 weeks), a total of 34.8 % of subjects experienced clinically significant weight increase (i.e., ≥ 7 % increase in body weight at endpoint).
Maltese: Fil-prova ta' estensjoni fit-tul (50 ġimgħa), total ta' 34.8 % tal-individwi esperjenzaw żieda filpiż klinikament sinifikanti (jiġifieri żieda ta' ≥ 7 % fil-piż tal-ġisem fil-punt tat-tmiem).
English: In subjects with severe hepatic impairment (Child-Pugh C), a 7-fold increase in asenapine exposure was observed (see section 4.2).
Maltese: F'persuni b'indeboliment sever tal-fwied (Child-Pugh Ċ), kienet osservata żieda ta' 7 darbiet fl-espożizzjoni għal asenapine (ara sezzjoni 4.2).
English: - Gently remove the tablet (Figure 2).
Maltese: - Neħħi l-pillola bil-mod (Figura 2).
English: Indicative of CYP2D6 inhibition, treatment with asenapine 5 mg twice daily resulted in a fractional decrease in DX/DM ratio to 0.43.
Maltese: B'mod indikattiv ta' inibizzjoni ta' CYP2D6, il-kura b'asenapine 5 mg darbtejn kuljum, irriżultat fi tnaqqis frazzjonali fil-proporzjon ta' DX/DM għal 0.43.
English: In a separate study, co-administration of a single 75 mg dose of imipramine with a single 5 mg dose of asenapine did not affect the plasma concentrations of the metabolite desipramine (a CYP2D6 substrate).
Maltese: Fi studju separat, l-għoti ta' doża waħda ta' 75 mg ta' imipramine flimkien ma' doża waħda ta' 5 mg ta' asenapine ma affettwax il-konċentrazzjonijiet fil-plażma tal-metabolit desipramine (substrat ta' CYP2D6).
English: The difference in LS mean change from baseline to Day 21 in the Y-MRS total score between asenapine 10 mg BID and placebo was -3.0 points (95 % CI [-5.6, -0.4]; p-value = 0.0244).
Maltese: Id-differenza fil-bidla medja fl-LS mil-linja bażi sal-Jum 21 fil-punteġġ totali ta' Y-MRS bejn asenapine 10 mg BID u plaċebo kienet -3.0 punti (95 % CI
English: Electrocardiogram QT prolonged Sinus tachycardia
Maltese: Imblokk talbundle branch Titwil talQT fl-elettrokardjogramm Takikardija tassinus
English: The clinically relevant adverse reactions identified in the paediatric trials were generally similar to those observed in the adult trials.
Maltese: Irreazzjonijiet avversi klinikament rilevanti identifikati fil-provi pedjatriċi kienu ġeneralment simili għal dawk osservati fil-provi tal-adulti.
English: The pharmacokinetics of asenapine following a single dose of 5 mg asenapine were similar among subjects with varying degrees of renal impairment and subjects with normal renal function.
Maltese: Il-farmakokinetika ta' asenapine wara doża waħda ta' 5 mg ta' asenapine kienet simili fost persuni bi gradi ta' indeboliment tal-kliewi li jvarjaw u persuni b'funzjoni tal-kliewi normali.
English: Maternal and embryo toxic effects were found in animal studies (see section5.3).
Maltese: Instabu effetti tossiċi materni u tal-embriju fi studji li saru fuq l-annimali (ara sezzjoni 5.3).
English: Overall mean (SD) weight gain at study endpoint was 3.5 (5.76) kg.
Maltese: Iż-żieda fil-piż medja globali (SD) fil-punt tat-tmiem tal-istudju kienet 3.5 (5.76) kg.
English: Sycrest 5 mg sublingual tablets Sycrest 10 mg sublingual tablets asenapine
Maltese: Sycrest 5 mg pilloli għal taħt l-ilsien Sycrest 10 mg pilloli għal taħt l-ilsien asenapine
English: Clinical drug interaction studies investigating the effects of CYP2D6 inhibition by asenapine showed the following results:
Maltese: Studji kliniċi dwar l-interazzjonijiet tal-mediċina li investigaw l-effetti ta' inibizzjoni ta' CYP2D6 minn asenapine, urew ir-riżultati li ġejjin:
English: Reported estimated doses were between 15 and 400 mg.
Maltese: L-istima tad-dożi rrappurtati kienet bejn 15 u 400 mg.
English: In an in vivo study in humans with radio-labelled asenapine, the predominant drug-related entity in plasma was asenapine +-glucuronide; others included N-desmethylasenapine, N-desmethylasenapine N-carbamoyl glucuronide, and unchanged asenapine in smaller amounts.
Maltese: +-glucuronide; oħrajn kienu jinkludu N-desmethylasenapine, N-desmethylasenapine N-carbamoyl glucuronide, u asenapine mhux mibdul f'ammonti iżgħar.
English: In one double-blind, fixed-dose, parallel-group, 3-week placebo controlled trial in subjects with bipolar I disorder experiencing an acute manic or mixed episode involving 367 patients of which 126 received placebo, 122 received asenapine 5 mg twice daily (BID), and 119 received asenapine 10 mg BID, the primary efficacy hypothesis was met.
Maltese: Fi prova waħda, ikkontrollata bi plaċebo, ta' 3 ġimgħat, bi grupp parallel, b'doża fissa, double-blind, f'indivdiwi b'disturb bipolari li esperjenzaw episodju manijaku jew imħallat akut li involva 367 pazjent li 126 minnhom ingħataw plaċebo, 122 ingħataw asenapine 5 mg darbtejn kuljum (BID), u 119 ingħataw asenapine 10 mg BID, l-ipoteżi tal-effikaċja primarja ntlaħqet.
English: Following an initial more rapid distribution phase, the terminal half-life of asenapine is approximately 24 h.
Maltese: Wara fażi inizjali iktar mgħaġġla ta' distribuzzjoni, il-half-life terminali ta' asenapine tkun ta' madwar 24 siegħa.
English: There is no specific antidote to Sycrest.
Maltese: M'hemmx antidot speċifiku għal Sycrest.
English: This medicine belongs to a group of medicines called antipsychotics.
Maltese: Din il-mediċina tappartjeni għal grupp ta' mediċini msejħa antipsikotiċi.
English: Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Maltese: Żidiet temporanji u asintomatiċi ta' transaminases, alanine transferase (ALT), u aspartate transferase (AST) fil-fwied kienu osservati b'mod komuni, speċjalment kmieni fil-kura.
English: Anxiety
Maltese: Suwiċidju
English: If a patient develops signs and symptoms indicative of NMS Sycrest must be discontinued.
Maltese: Jekk pazjent jiżviluppa sinjali u sintomi indikattivi ta' NMS, Sycrest irid jitwaqqaf.
English: Both asenapine doses (5 mg BID and 10 mg BID) were superior to placebo and showed statistically significant improvement in change from baseline in Y-MRS total score at Day 21 compared with placebo.
Maltese: Iż-żewġ dożi ta' asenapine (5 mg BID u 10 mg BID) kienu superjuri għall-plaċebo u urew titjib statistikament sinifikanti fil-bidla il-linja bażi filpunteġġ totali ta' Y-MRS fil-Jum 21 meta mqabbel ma' plaċebo.
English: Lundbeck Croatia d.o.o.
Maltese: Lundbeck Poland Sp. z o. o.
English: The most common adverse reactions (proportion of patients  5 % and at least twice placebo) reported in paediatric patients with schizophrenia were somnolence, sedation, akathisia, dizziness, and hypoaesthesia oral.
Maltese: L-aktar reazzjonijiet avversi komuni (proporzjon ta' pazjenti > 5 % u mill-anqas darbtejn plaċebo) irrapportati f'pazjenti pedjatriċi bi skizofrenja kienu ngħas, sedazzjoni, akatisja, sturdament, u ipoestesija orali.
English: Each sublingual tablet contains 10 mg asenapine (as maleate).
Maltese: Kull pillola għal taħt l-ilsien fiha 10 mg ta' asenapine (bħala maleate).
English: Asenapine exposure is increased 7-fold in patients with severe hepatic impairment (Child-Pugh C).
Maltese: L-espożizzjoni għal asenapine tiżdied b'7 darbiet f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh Ċ).
English: The most common adverse reactions (≥ 5 % and at least twice the rate of placebo) reported in paediatric patients with bipolar I disorder were somnolence, sedation, dizziness, dysgeusia, hypoaesthesia oral, paraesthesia oral, nausea, increased appetite, fatigue, and weight increased (see Weight increase above).
Maltese: L-aktar reazzjonijiet avversi komuni (≥ 5% u mill-anqas darbtejn ir-rata ta' plaċebo) irrapportati f'pazjenti pedjatriċi b'disturbi bipolari kienu ngħas, sedazzjoni, sturdament, disgewżja, ipoestesija orali, parasteżija orali, dardir, żieda fl-aptit, għeja, u żieda fil-piż (ara Żieda fil-piż hawn fuq).
English: The safety and efficacy of Sycrest was evaluated in 403 paediatric patients with bipolar I disorder who participated in a single, 3-week, placebo-controlled, double-blind trial, of whom 302 patients received Sycrest at fixed doses ranging from 2.5 mg to 10 mg twice daily.
Maltese: Is-sigurtà u l-effikaċja ta' Sycrest ġiet evalwata f'403 pazjenti pedjatriċi b'disturb bipolari I li pparteċipaw fi prova double-blind, ikkontrollata bi plaċebo, ta' tliet ġimgħat waħdanija, li minnhom, 302 pazjenti rċevew Sycrest f'dożi fissi li jvarjaw minn 2.5 mg u 10 mg darbtejn kuljum.
English: Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.
Maltese: Folji tal-aluminju/aluminju li jistgħu jitqaxxru, f'kaxxi tal-kartun ta' 20, 60 jew 100 pillola għal taħt l-ilsien f'kull kaxxa tal-kartun.
English: The incidence of orthostatic hypotension in elderly subjects was 4.1 % compared to 0.3 % in the combined phase 2/3 trial population.
Maltese: L-inċidenza ta' pressjoni tad-demm baxxa ortostatika f'persuni anzjani kienet ta' 4.1 % meta mqabbel ma' 0.3 % fil-fażi 2/3 kombinata fil-popolazzjoni li fuqha kienet qed issir il-prova.
English: The efficacy of asenapine in the treatment of a DSM-IV manic or mixed episode of bipolar I disorder with or without psychotic features was evaluated in two similarly designed 3-week, randomized, double-blind, flexible-dose, placebo- and active controlled (olanzapine) monotherapy trials involving 488 and 489 patients, respectively.
Maltese: Il-provi damu 3 ġimgħat, li fihom il-parteċipanti ntgħażlu b'mod każwali, kienu double-blind, b'doża flessibbli, ikkontrollati bi plaċebo u b'mod attiv (olanzapine), li kienu jinvolvu 488 u 489 pazjenti, rispettivament.
English: Antipsychotic medicines affect the chemicals that allow communication between nerve cells (neurotransmitters).
Maltese: Mediċini antipsikotiċi jaffettwaw il-kimiċi li jippermettu l-komunikazzjoni bejn ċelluli tan-nervituri (newrotrasmettituri).
English: From the clinical trials, it is concluded that clinically relevant body temperature dysregulation does not appear to be associated with asenapine.
Maltese: Mill-provi kliniċi, ġie stabbilit li diżregolazzjoni klinikament rilevanti tat-temperatura tal-ġisem ma tidhirx li hi assoċjata ma' asenapine.
English: In clinical trials, there were few adverse reactions related to abnormal prolactin levels reported.
Maltese: Fi provi kliniċi, kien hemm ftit reazzjonijiet avversi rrappurtati li kienu marbuta ma' livelli anormali ta' prolactin.
English: * See subsection “Falls” below
Maltese: * Ara s-sottosezzjoni “Waqgħat” hawn taħt
English: Peelable blister.
Maltese: Tfarrakx il-pillola.
English: - Each Sycrest 5 mg sublingual tablet contains 5 mg asenapine.
Maltese: - Kull Sycrest 5 mg pillola għal taħt l-ilsien fiha 5 mg asenapine.
English: Common side effects (may affect up to 1 in 10 people) - weight gain - increased appetite - slow or sustained muscle contractions - restlessness - involuntary muscle contractions - slow movements, tremor - sedation - dizziness - nausea - change in taste - numb feeling of the tongue or in the mouth
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) - żieda fil-piż - żieda fl-aptit - kontrazzjonijiet bil-mod jew sostnuti tal-muskoli - nuqqas ta' kwiet f'ġismek - kontrazzjonijiet involontarji tal-muskoli - movimenti bil-mod, rogħda - sedazzjoni - sturdament - dardir
English: Asenapine was not teratogenic in animal studies.
Maltese: Asenapine ma kienx teratoġeniku fi studji fuq lannimali.
English: Clinical efficacy in bipolar I disorder
Maltese: Effikaċja klinika f'disturb bipolari I
English: Drug withdrawal syndrome neonatal (see 4.6)
Maltese: Sindrome ta' meta tieqaf tieħu lmediċina fi trabi tat-twelid (ara 4.6)
English: - Each Sycrest 10 mg sublingual tablet contains 10 mg asenapine.
Maltese: - Kull Sycrest 10 mg pillola għal taħt l-ilsien fiha 10 mg asenapine.
English: Asenapine is not indicated for the treatment of children and adolescent patients below 18 years (see section 4.2).
Maltese: Asenapine mhuwiex indikat għall-kura ta' pazjenti tfal u adoloxxenti li għandhom inqas minn 18-il sena (ara sezzjoni 4.2).
English: Asenapine does not cause induction of CYP1A2 or CYP3A4 activities in cultured human hepatocytes.
Maltese: Asenapine ma jikkawżax induzzjoni ta' attivitajiet ta' CYP1A2 jew CYP3A4 f'epatoċiti kolturati tal-bniedem.
English: Sycrest 5 mg sublingual tablets asenapine
Maltese: Sycrest 5 mg pilloli għal taħt l-ilsien asenapine
English: Sycrest 10 mg sublingual tablets asenapine
Maltese: Sycrest 10 mg pilloli għal taħt l-ilsien asenapine
English: Limited data on efficacy in patients 65 years of age and older are available.
Maltese: Hemm dejta limitata disponibbli dwar l-effikaċja f'pazjenti li għandhom 65 sena u iżjed.
English: In subjects with severe hepatic impairment (Child-Pugh C), a 7-fold increase in asenapine exposure was observed.
Maltese: F'persuni b'indeboliment sever tal-fwied (Child-Pugh Ċ), kienet osservata żieda ta' 7 darbiet fl-espożizzjoni għal asenapine.
English: SIA Lundbeck Latvia Tel: + 371 6 7 067 884
Maltese: Tel: + 371 6 7 067 884
English: EU/1/10/640/004 EU/1/10/640/005 EU/1/10/640/006
Maltese: EU/1/10/640/005
English: Sycrest activity is primarily due to the parent compound.
Maltese: L-attività ta' Sycrest hi primarjament minħabba l-kompost prinċipali.
English: Other medicines and Sycrest
Maltese: Mediċini oħrau Sycrest
English: However, asenapine may enhance the inhibitory effects of paroxetine on its own metabolism.
Maltese: Madankollu, asenapine jista' jtejjeb l-effetti inibitorji ta' paroxetine bil-metaboliżmu tiegħu stess.
English: Each sublingual tablet contains 5 mg asenapine (as maleate).
Maltese: Kull pillola għal taħt l-ilsien fiha 5 mg ta' asenapine (bħala maleate).
English: tongue, or jaw, slow or sustained muscle contractions, muscle spasms, tremor (shaking),
Maltese: (titriegħed), movimenti mhux normali tal-għajnejn, kontrazzjonijiet involontarji tal-muskoli,
English: The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at endpoint) in the short-term, flexible-dose bipolar mania trials was 6.5 % for asenapine compared to 0.6 % for placebo.
Maltese: Il-proporzjon ta' persuni b'żieda fil-piż li kienet klinikament sinifikanti (≥ 7 % żieda fil-piż mil-linja bażi fil-punt aħħari) fi provi kliniċi dwar manija bipolari, b'doża fissa li damu żmien qasir, kien ta' 6.5 % għal asenapine meta mqabbel ma' 0.6 % għal plaċebo.
English: The possibility of elevated asenapine plasma levels cannot be excluded in some patients with moderate hepatic impairment (Child-Pugh B) and caution is advised.
Maltese: Ilpossibbiltà ta' livelli għolja ta' asenapine fil-plażma ma tistax tiġi eskluża f'xi pazjenti b'indeboliment moderat tal-fwied (Child-Pugh B) u l-kawtela hi rakkomandata.
English: A pharmacokinetic study and a short term efficacy and safety study were performed in a paediatric population (ages 10-17 years) with manic or mixed episodes associated with bipolar I disorder.
Maltese: Sar studju farmakokinetiku u sar studju dwar l-effikaċja u s-sigurtà għal żmien qasir f'popolazzjoni pedjatrika (età minn 10 sa 17-il sena) b'episodji manijaċi jew imħallta assoċjati mad-disturb bipolari I.
English: Extrapyramidal disorder Dysarthria Restless legs syndrome
Maltese: Aċċessjonijiet Disturb extrapiramidali Disartrija Sindrome tassaqajn bla serħan
English: The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at endpoint) in the short-term schizophrenia trials was 5.3 % for asenapine compared to 2.3 % for placebo.
Maltese: Il-proporzjon ta' persuni b'żieda fil-piż li kienet klinikament sinifikanti (≥ 7 % żieda fil-piż mil-linja bażi fil-punt aħħari) fi provi kliniċi dwar skiżofrenija li damu żmien qasir, kien ta' 5.3 % għal asenapine meta mqabbel ma' 2.3 % għal plaċebo.
English: OUTER CARTON (5 mg)
Maltese: KARTUNA TA' BARRA (5 mg)
English: You should avoid drinking alcohol when taking this medicine.
Maltese: Għandek tevita li tixrob l-alkoħol meta tkun qed tieħu din il-mediċina.
English: EXP
Maltese: Sinkope
English: For combination therapy a starting dose of 5 mg twice daily is recommended.
Maltese: Għal terapija kombinata, hi rrakkomandata doża talbidu ta' 5 mg darbtejn kuljum.
English: If you are taking other medicines, Sycrest should be taken last.
Maltese: Xi mediċini jistgħu jnaqqsujewiżidul-effett ta' Sycrest.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder in newborn infants.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonija, ipotonija, rogħda, ħedla, skumdità respiratorja, jew disturb fit-treddigħ fi trabi tat-twelid.
English: Treatment with Sycrest is not advised in patients who are unable to comply with this method of administration, as the bioavailability of asenapine when swallowed is low (< 2 % with an oral tablet formulation).
Maltese: Il-kura b'Sycrest mhijiex rakkomandata f'pazjenti li ma jistgħux ikunu konformi ma' dan il-metodu ta' għoti, għax il-bijodisponibilità ta' asenapine meta jinbela' hi baxxa (< 2 % b'formulazzjoni ta' pillola orali).
English: OUTER CARTON (10 mg)
Maltese: KARTUNA TA' BARRA (10 mg)
English: In in vitro assays asenapine acts as an antagonist at these receptors.
Maltese: F'assaġġi in vitro, asenapine jaġixxi bħala antagonista fuq dawn ir-riċetturi.
English: Asenapine may antagonise the effect of levodopa and dopamine agonists.
Maltese: Asenapine jista' jantagonizza l-effett ta' levodopa u agonisti ta' dopamine.
English: Somnolenc
Maltese: Anzjani
English: Asenapine is rapidly distributed and has a large volume of distribution (approximately 20-25 L/kg), indicating extensive extravascular distribution.
Maltese: L/kg), li jindika distribuzzjoni extravaskulari estensiva.
English: Lundbeck Austria GmbH Tel: +43 1 266 91 08
Maltese: Lundbeck Croatia d.o.o. Tel: +385 1 364 92 10
English: Asenapine may induce orthostatic hypotension and syncope, especially early in treatment, probably reflecting its α1-adrenergic antagonist properties.
Maltese: Asenapine jista' jikkaġuna pressjoni tad-demm baxxa ortostatika u sinkope, speċjalment kmieni fil-kura, u dan probabbilment jirrifletti l-karatteristiċi antagonisti adrenerġiċi α1 tiegħu.
English: Salivary hypersecretion
Maltese: Disturbi filqalb
English: Lundbeck Export A/S Reprezentanţa din România
Maltese: Lundbeck Export A/S Reprezentanţa din România Tel: +40 21319 88 26
English: The recommended starting dose of Sycrest as monotherapy is 5 mg twice daily.
Maltese: Għal terapija kombinata, hi rrakkomandata doża tal-bidu ta' 5 mg darbtejn kuljum.
English: Therefore, Sycrest should be co-administered cautiously with medicinal products that are both substrates and inhibitors for CYP2D6.
Maltese: Għalhekk, Sycrest għandu jingħata b'kawtela flimkien ma' prodotti mediċinali li huma kemm substrati kif ukoll inibituri għal CYP2D6.
English: Furthermore, prolactin-mediated effects on mammary glands and oestrus cycle disturbances were observed.
Maltese: Flimkien ma' dan, effetti medjati minn prolactin fuq il-glandoli mammarji u disturbi taċ-ċiklu oestrus kienu osservati.
English: Cerebrovascular events have been reported in patients treated with asenapine but there is no evidence of any excess incidence over what is expected in adults between 18 and 65 years of age.
Maltese: Avvenimenti ċerebrovaskulari kienu rrappurtati f'pazjenti kkurati b'asenapine, iżda m'hemm l-ebda evidenza ta' kwalunkwe inċidenza eċċessiva fuq dak li hu mistenni f'persuni adulti li għandhom bejn 18 u 65 sena.
English: Asenapine demonstrated superior efficacy to placebo in the reduction of manic symptoms over 3 weeks.
Maltese: Asenapine wera effikaċja superjuri fuq il-plaċebo fit-tnaqqis ta' sintomi maniċi fuq perjodu ta' 3 ġimgħat.
English: In a PK study using unflavoured sublingual tablets, at the 5 mg twice daily dose level, asenapine pharmacokinetics in adolescent patients (12 to 17 years of age, inclusive) are similar to those observed in adults.
Maltese: Fi studju PK li juża pilloli għal taħt l-ilsien mingħajr togħma, fil-livell ta' doża ta' 5 mg darbtejn kuljum, ilfarmakokinetika ta' asenapine f'pazjenti adolexxenti (minn 12 sa 17-il sena, inklużi) hi simili għal dik osservata f'persuni adulti.
English: Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia or bipolar disorder and the increasing incidence of diabetes mellitus in the general population.
Maltese: Pazjenti anzjani bi psikosi marbuta mad-dimenzja, ikkurati b'sustanzi antipsikotiċi, huma f'riskju miżjud ta' mewt.
English: Falls may occur as a result of one or more adverse events such as the following: Somnolence, Orthostatic hypotension, Dizziness, Extrapyramidal symptoms.
Maltese: Ngħas, Pressjoni baxxa ortostatika, Sturdament, Sintomi extrapiramidali.
English: Parkinson's disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing Sycrest to patients with Parkinson's disease or dementia with Lewy Bodies (DLB) since both groups may be at increased risk of neuroleptic malignant syndrome as well as having an increased sensitivity to antipsychotics.
Maltese: It-tobba għandhom jiżnu r-riskji kontra l-benefiċċji meta jagħtu riċetta għal Sycrest lil pazjenti bil-marda ta' Parkinson jew dimenzja b'Lewy Bodies (DLB) għax iż-żewġ gruppi jistgħu jkunu f'riskju miżjud ta' Sindrome Newroleptiku Malinn kif ukoll ikollhom żieda fis-sensittività għal mediċini antipsikotiċi.
English: The incidence of dystonia in paediatric clinical trials using a gradual up-titration was similar to that seen in adult trials.
Maltese: L-inċidenza ta' distonja fil-provi kliniċi pedjatriċi bl-użu ta' titrazzjoni 'l fuq gradwali kienet simili għal dik osservata fi provi tal-adulti.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Sycrest in one or more subsets of the paediatric population in bipolar I disorder (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Sycrest 5 mg sublingual tablets
Maltese: Sycrest 5 mg pilloli għal taħt l-ilsien