FrancophonIA/ELRC3.0 huggingface dataset:
English: After one year, 14% of the patients receiving Advagraf had experienced organ failure.
Maltese: Wara sena, 14% tal-pazjenti li kienu qed jieħdu Advagraf esperjenzaw falliment ta' xi organu.
English: In liver transplant, the starting dose is 0.10 to 0.20 mg/kg.
Maltese: Fil-każ ta' trapjant tal-fwied, id-doża tal-bidu hi 0.10 sa 0.20 mg/kg.
English: The most common side effects with Advagraf (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Maltese: L-iktar effetti sekondarji komuni b'Advagraf (li dehru f'iktar minn pazjent wieħed minn kull 10) huma rogħda, uġigħ ta' ras, nawżea (dardir), dijarrea, problemi bil-kliewi, ipergliċemija (livell għoli ta' glukożju fid-demm), dijabete, iperkaljemija (livell għoli ta' potassju fid-demm), ipertensjoni (pressjoni tad-demm għolja) u insonnja (tbatija fl-irqad).
English: This summary was last updated in 02-2008.
Maltese: Dan is-sommarju ġie aġġornat fi: 02-2008.
English: It also presented the results of a clinical study in 668 kidney transplant patients comparing the use of Advagraf with that of Prograf/Prograft or ciclosporin (another immunosuppressive medicine used in the prevention of rejection).
Maltese: Ippreżentat ukoll ir-riżultati ta' studju kliniku f'668 pazjent li kienu rċevew trapjant tal-kliewi li qabbel l-użu ta' Advagraf ma' dak ta' Prograf/Prograft jew iċ-ċiklosporina (mediċina immunosoppressiva oħra użata fil-prevenzjoni tar-rifjut).
English: What is the risk associated with Advagraf?
Maltese: X'riskju hu assoċjat ma' l-użu ta' Advagraf?
English: Patients also received mycophenolate mofetil (another medicine used in the prevention of rejection).
Maltese: Il-pazjenti rċevew ukoll mikofenolat mofetil (mycophenolate mofetil) (mediċina oħra użata fil-prevenzjoni tar-rifjut).
English: Advagraf is very similar to Prograf/Prograft, but the way the medicine is made has been changed so that the active substance is released more slowly from the capsule than it is in Prograf/Prograft.
Maltese: Advagraf jixbah ħafna lil Prograf/Prograft, iżda l-mod li bih issir il-mediċina nbidel biex iħalli s-sustanza attiva tintreħa iktar bil-mod mill-kapsula milli jseħħ bi Prograf/Prograft.
English: In kidney transplant, the starting dose is 0.20 to 0.30 mg per kilogram body weight.
Maltese: Fil-każ ta' trapjant tal-kliewi, id-doża tal-bidu hi 0.20 sa 0.30 mg għal kull kilogramma li jiżen il-pazjent.
English: The medicine can only be obtained with a prescription.
Maltese: Advagraf kien effikaċi daqs iż-żewġ mediċini li tqabbel magħhom.
English: Why has Advagraf been approved?
Maltese: Għaliex ġie approvat Advagraf?
English: What is Advagraf?
Maltese: X'inhu Advagraf?
English: How has Advagraf been studied?
Maltese: Kif ġie studjat Advagraf?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Advagraf's benefits are greater than its risks for the prophylaxis of transplant rejection in adult kidney and liver allograft recipients, and in the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Advagraf huma ikbar mir-riskji fil-profilassi tar-rifjut tat-trapjant fil-pazjenti adulti li rċevew trapjant alloġeniku (allograft recipients) ta' kilwa jew tal-fwied, u fit-trattament tar-rifjut alloġeniku reżistenti għat-terapija b'mediċini immunosoppressivi oħra fil-pazjenti adulti.
English: Other information about Advagraf:
Maltese: Aktar tagħrif dwar Advagraf:
English: Advagraf is used in adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Maltese: Advagraf jintuża f'pazjenti adulti li kellhom trapjant tal-kilwa jew tal-fwied biex ikun evitat rifjut (rejection) (meta s-sistema immunitarja tattakka l-organu trapjantat).
English: Starting doses are 0.10 to 0.30 mg/kg in other types of transplant (heart, lung, pancreas or intestine).
Maltese: Id-dożi tal-bidu f'tipi oħra ta' trapjanti (tal-qalb, tal-pulmun, tal-frixa (pankreas), tal-musrana (intestin) huma bejn 0.10 u 0.30 mg/kg.
English: Because tacrolimus and Prograf/Prograft have already been used in the EU, the company presented the results of studies that had been carried out with Prograf/Prograft previously, as well as data from the published literature.
Maltese: Billi tacrolimus u Prograf/Prograft kienu diġà jintużaw fl-UE, il-kumpanija ppreżentat ir-riżultati ta' studji li kienu saru qabel bi Prograf/Prograft, kif ukoll dejta minn xi studji ppubblikati.
English: Doctors should monitor the levels of tacrolimus in the blood to check that they stay within predefined ranges.
Maltese: It-tobba għandhom jissorveljaw il-livelli ta' tacrolimus fid-demm biex jivverifikaw li għadhom fil-livelli predefiniti.
English: In the European Union (EU), it has been available as capsules under the name Prograf or Prograft (depending on the country).
Maltese: Fl-Unjoni Ewropea (UE), kien jiġi bħala kapsuli jisimhom Prograf jew Prograft (l-isem ivarja skond il-pajjiż).
English: Advagraf should not be used in people who may be hypersensitive (allergic) to tacrolimus, to macrolide antibiotics (such as erythromycin) or to any of the other ingredients.
Maltese: Advagraf m'għandux jintuża f'persuni li huma ipersensittivi (allerġiċi) għal tacrolimus, għal antibijotiċi makrolidi (bħal eritromiċina [erythromycin]) jew għal sustanzi oħra.
English: Further shorter studies were also carried out in 119 kidney transplant patients and 129 liver transplant patients, looking at how Advagraf is absorbed by the body in comparison to Prograf/Prograft.
Maltese: Saru xi studji qosra oħra f'119-il pazjent li rċevew trapjant tal-kliewi u f'129 pazjent li rċevew trapjant tal-fwied, b'analiżi ta' kif Advagraf ġie assorbit fil-ġisem meta mqabbel ma' Prograf/Prograft.
English: How does Advagraf work?
Maltese: Għal xiex jintuża Advagraf?
English: This means that it reduces the activity of the immune system (the body's natural defences).
Maltese: Dan ifisser li jnaqqas l-attività tas-sistema immunitarja (id-difiża naturali tal-ġisem).
English: B-2220 Heist-op-den-Berg, Belgium
Maltese: B-2220 Heist-op-den-Berg, Il-Belġju
English: Drynam Road, Swords, Co. Dublin Ireland
Maltese: Drynam Road, Swords, Co. Dublin L-Irlanda
English: Extrapyramidal Symptoms (EPS)
Maltese: Sintomi Extrapiramidali (EPS)
English: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
Maltese: N.V. Organon, Kloosterstraat 6, 5349 AB Oss, L-Olanda
English: Vistor hf
Maltese: Ísland Vistor hf
English: NL- 5349 AB Oss The Netherlands
Maltese: NL- 5349 AB Oss L-Olanda
English: Packs may contain 20, 60 or 100 tablets.
Maltese: Il-pakketti jista' jkun fihom 20, 60 jew 100 pillola.
English: Alanine aminotransferas e increased
Maltese: Żieda f'alanine aminotransferase
English: Gynaecomastia Galactorrhoea
Maltese: Ġinekomastija Galaktorroea
English: België/Belgique/Belgien Lundbeck N.V./S.A.
Maltese: België/Belgique/Belgien Lundbeck N.V./S.
English: Luxembourg/Luxemburg Lundbeck N.V./S.A.
Maltese: Luxembourg/Luxemburg Lundbeck N.V./S.
English: Paediatric population (children and adolescents)
Maltese: Popolazzjoni pedjatrika (tfal u adolexxenti)
English: Sexual dysfunction Amenorrhoea
Maltese: Disfunzjoni sesswali Amenorrea
English: The absolute bioavailability of asenapine when swallowed is low (< 2 % with an oral tablet formulation).
Maltese: Il-bijodisponibilità assoluta ta' asenapine meta jinbela' hi baxxa (< 2 % b'formulazzjoni ta' pillola orali).
English: Asenapine is highly bound (95 %) to plasma proteins, including albumin and α1-acid glycoprotein.
Maltese: Asenapine jeħel ħafna mal-proteini fil-plażma (95 %), li jinkludu lalbumina u glikoproteina α1-acid.
English: Pharmacotherapeutic group: Psycholeptics, antipsychotics, ATC code: N05AH05
Maltese: Psikoleptiċi, mediċini antipsikotiċi, Kodiċi ATC:
English: Sinus bradycardia Bundle branch block
Maltese: Imblokk tal-bundle branch
English: Other serious ADRs are discussed in more detail in section 4.4.
Maltese: ADRs serji oħra qed jiġu diskussi f'aktar dettall fis-sezzjoni 4.4.
English: Neuroleptic malignant syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur with antipsychotics, including asenapine.
Maltese: Is-Sindromu Malinn Newroleptiku (NMS), ikkaratterizzat minn ipertermija, ebusija tal-muskoli, instabilità awtonomika, tibdil fil-koxjenza u livelli għolja ta' creatine phosphokinase fis-serum, kien irrappurtat li jseħħ b'mediċini antipsikotiċi, li jinkludu asenapine.
English: Sycrest contains the active substance asenapine.
Maltese: Sycrest fih is-sustanza attiva asenapine.
English: - Peel back the coloured tab (Figure 1).
Maltese: - Qaxxar lura il-parti ikkulurita (Figura 1).
English: The pharmacokinetics of asenapine were similar among subjects with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and subjects with normal hepatic function.
Maltese: Il-farmakokinetika ta' asenapine kienet simili fost persuni b'indeboliment tal-fwied ħafif (Child-Pugh A) jew moderat (Child-Pugh B), u persuni b'funzjoni normali tal-fwied.
English: Date of first authorisation: 01 September 2010 Date of latest renewal: 05 May 2015
Maltese: Data tal-aħħar tiġdid: 5 ta' Mejju 2015
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000) and not known (cannot be estimated from the available data).
Maltese: L-ADRs kollha huma elenkati skont il-sistema tal-klassifika tal-organi u frekwenza; komuni ħafna (≥ 1/10), komuni ( 1/100 sa < 1/10), mhux komuni ( 1/1,000 sa < 1/100), rari ( 1/10,000 sa < 1/1,000), u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: The potential effects of inhibitors and an inducer of several of these enzyme pathways on asenapine pharmacokinetics were studied, specifically fluvoxamine (CYP1A2 inhibitor), paroxetine (CYP2D6 inhibitor), imipramine (CYP1A2/2C19/3A4 inhibitor), cimetidine (CYP3A4/2D6/1A2 inhibitor), carbamazepine (CYP3A4/1A2 inducer) and valproate (UGT inhibitor).
Maltese: Ġew studjati l-effetti potenzjali ta' inibituri u indutturi ta' diversi passaġġi ta' enzimi minn dawn fuq il-farmakokinetika ta' asenapine, speċifikament fluvoxamine (inibitur ta' CYP1A2), paroxetine (inibitur ta' CYP2D6), imipramine (inibitur ta' CYP1A2/2C19/3A4), cimetidine (inibitur ta' CYP3A4/2D6/1A2), carbamazepine (induttur ta' CYP3A4/1A2) u valproate (inibitur ta' UGT). Ħlief għall-fluvoxamine, l-ebda wieħed mill-prodotti mediċinali li jinteraġixxu ma rriżulta f'bidliet klinikament rilevanti fil-farmakokinetika ta' asenapine.
English: What Sycrest contains - The active substance is asenapine.
Maltese: X'fih Sycrest - Is-sustanza attiva hi asenapine.
English: A statistically significant difference between asenapine and placebo was seen as early as day 2.
Maltese: Differenza statistikament sinifikanti bejn asenapine u plaċebo ġiet osservata sa mill-jum 2.
English: The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia.
Maltese: Ilbidu ta' sintomi extrapiramidali hu fattur ta' riskju għal diskinesija tardiva.
English: - The other ingredients are gelatin and mannitol (E421).
Maltese: - Is-sustanzi l-oħra huma gelatin u mannitol (E421).
English: In a 3-week, placebo-controlled, randomized, fixed-dose efficacy and safety trial in paediatric patients 10 to 17 years of age with bipolar I disorder, the mean change from baseline to endpoint in weight for placebo and asenapine 2.5 mg, 5 mg, and 10 mg twice daily, was 0.48, 1.72, 1.62, and 1.44 kg, respectively.
Maltese: Fi prova ta' 3 ġimgħat, ikkontrollata bi plaċebo, randomizzata, l-effikaċja ta' doża fissa u l-prova tas-sigurtà f'pazjenti pedjatriċi li għandhom bejn 10 u 17-il sena b'disturbi bipolari I, il-bidla medja mil-linja bażi salpunt ta' tmiem fil-piż għall-plaċebo u asenapine 2.5 mg, 5 mg, u 10 mg darbtejn kuljum, kienet 0.48, 1.72, 1.62, u 1.44 kg, rispettivament.
English: NL-5349 AB Oss The Netherlands
Maltese: NL-5349 AB
English: Uncommon side effects (may affect up to 1 in 100 people) - abnormal muscle movements: a collection of symptoms known as extrapyramidal symptoms
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) - movimenti mhux normali tal-muskoli: ġabra ta' sintomi magħrufa bħala sintomi extrapiramidali (EPS)
English: In the same study, treatment with paroxetine 20 mg daily decreased the DX/DM ratio to 0.032.
Maltese: Fl-istess studju, il-kura b'paroxetine 20 mg kuljum, naqqset il-proporzjon ta' DX/DM għal 0.032.
English: However, when tested in vitro it was devoid of phototoxicity.
Maltese: Madankollu, meta ġie ttestjat in vitro, instab li ma kellu l-ebda fototossiċità.
English: Asenapine exhibits high affinity for serotonin 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT5, 5-HT6, and 5-HT7 receptors, dopamine D2, D3, D4, and D1 receptors, α1 and α2-adrenergic receptors, and histamine H1 receptors, and moderate affinity for H2 receptors.
Maltese: Asenapine juri affinità kbira għar-riċetturi 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT5, 5-HT6, u 5-HT7 ta' serotonin, ir-riċetturi D2, D3, D4, u D1 ta' dopamine, ir-riċetturi adrenerġiċi α1 u α2, u r-riċetturi
English: Manufacturer Organon (Ireland) Ltd. Drynam Road, Swords Co. Dublin, Ireland
Maltese: Drynam Road, Swords Dublin, L-Irlanda
English: Fertility No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Maltese: Fertilità Ma kien osservat l-ebda indeboliment fil-fertilità fi studji mhux kliniċi (ara sezzjoni 5.3).
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Actions at other receptors e.g., 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3, and α2-adrenergic receptors, may also contribute to the clinical effects of asenapine.
Maltese: Azzjonijiet f'riċetturi oħrajn eż., 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3, u riċetturi α2-adrenerġiċi, jistgħu jikkontribwixxu wkoll għall-effetti kliniċi ta' asenapine.
English: Asenapine has anaesthetic properties.
Maltese: Asenapine għandu proprjetajiet anestetiċi.
English: Overall, steady-state asenapine pharmacokinetics are similar to single-dose pharmacokinetics.
Maltese: Globalment, il-farmakokinetika ta' asenapine fl-istat fiss hi simili għal farmakokinetika ta' dożi waħidhom.
English: The absolute bioavailability of sublingual asenapine at 5 mg is 35 %.
Maltese: Il-bijodisponibilità assoluta ta' asenapine mogħti taħt lilsien f'dożi ta' 5 mg hi ta' 35 %.
English: Treatment-related adverse reactions included agitation and confusion, akathisia, orofacial dystonia, sedation, and asymptomatic ECG findings (bradycardia, supraventricular complexes, intraventricular conduction delay).
Maltese: Reazzjonijiet avversi marbuta mal-kura kienu jinkludu aġitazzjoni u konfużjoni, akatixja, distonija orofaċjali, sedazzjoni, u sejbiet asintomatiċi ta' ECG (bradikardija, kumplessi supraventrikulari, dewmien fil-konduzzjoni intraventrikulari).
English: During combined administration with a single dose of asenapine 5 mg, fluvoxamine 25 mg twice daily resulted in a 29 % increase in asenapine AUC.
Maltese: Waqt l-għoti kombinat b'doża waħda ta' asenapine 5 mg, fluvoxamine 25 mg darbtejn kuljum irriżulta f'żieda ta' 29 % fl-AUC ta' asenapine.
English: BLISTER (10 mg)
Maltese: FOLJA (10 mg)
English: Asenapine is a weak inhibitor of CYP2D6.
Maltese: Asenapine hu inibitur dgħajjef ta' CYP2D6.
English: Efficacy of Sycrest was not demonstrated in an 8-week, placebo-controlled, double-blind, randomized, fixed-dose trial in 306 adolescent patients aged 12-17 years with schizophrenia at doses of 2.5 and 5 mg twice daily.
Maltese: L-effikaċja ta' Sycrest ma ntweritx fi prova b'doża fissa ta' 8 ġimgħat, ikkontrollata bi plaċebo, doubleblind, randomizzata fi 306 pazjenti adoloxxenti ta' bejn 12 u 17-il sena bi skizofrenija f'dożi ta' 2.5 u 5 mg darbtejn kuljum.
English: BLISTER (5 mg)
Maltese: FOLJA (5 mg)
English: abnormal movements of the eyes, involuntary muscle contractions, slow movements, or restlessness - unpleasant sensations in the legs (also called restless legs syndrome) - speech problems - abnormal slow or fast heartbeat - middle heart block - abnormal electrocardiogram (prolongation of the QT interval) - low blood pressure upon standing - low blood pressure - tingling of the tongue or in the mouth - swollen or painful tongue - difficulty in swallowing - ulcers, soreness, redness, swelling, and blisters within the mouth - sexual dysfunction - lack of regular menstrual periods
Maltese: movimenti bil-mod, jew nuqqas ta' kwiet f'ġismek - sensazzjonijiet spjaċevoli fir-riġlejn (imsejħa wkoll sindrome tas-saqajn bla serħan) - problemi biex titkellem - rata ta' taħbit tal-qalb bil-mod jew mgħaġġel b'mod mhux normali - imblokk fil-parti ċentrali tal-qalb - elettrokardjogramm mhux normali (titwil tal-intervall QT) - pressjoni tad-demm baxxa meta tqum bilwieqfa - pressjoni tad-demm baxxa - tnemnim tal-ilsien jew fil-ħalq - ilsien minfuħ jew bl-uġigħ - diffikultà biex tibla' - ulċeri, uġigħ, ħmura, nefħa, u nfafet fil-ħalq - disfunzjoni sesswali - nuqqas ta' mestrwazzjoni regolari
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Maltese: Sinjali kliniċi addizzjonali jistgħu jinkludu mijoglobinurija (rabdomijolosi) u insuffiċjenza akuta tal-kliewi.
English: Merck Sharp & Dohme, inovativna zdravila d.o.o.
Maltese: Slovenská republika Merck Sharp & Dohme, s. r. o.
English: EU/1/10/640/004 20 sublingual tablets EU/1/10/640/005 60 sublingual tablets EU/1/10/640/006 100 sublingual tablets
Maltese: EU/1/10/640/004 20 pillola għal taħt l-ilsien EU/1/10/640/005 60 pillola għal taħt l-ilsien EU/1/10/640/006 100 pillola għal taħt l-ilsien
English: 20 sublingual tablets 60 sublingual tablets 100 sublingual tablets
Maltese: 20 pillola għal taħt l-ilsien 60 pillola għal taħt l-ilsien 100 pillola għal taħt l-ilsien
English: Following co-administration of dextromethorphan and asenapine in healthy subjects, the ratio of dextrorphan/dextromethorphan (DX/DM) as a marker of CYP2D6 activity was measured.
Maltese: Wara l-għoti ta' dextromethorphan flimkien ma' asenapine f'persuni b'saħħithom, tkejjel il-proporzjon ta' dextrorphan/dextromethorphan (DX/DM) bħala markatur ta' attività ta' CYP2D6.
English: The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at Day 21) was 14.1 % for asenapine 2.5 mg twice daily, 8.9 % for asenapine 5 mg twice daily, and 9.2 % for asenapine 10 mg twice daily, compared to 1.1 % for placebo.
Maltese: Il-proporzjon ta' individwi b'żieda fil-piż klinikament sinifikanti (≥ 7 % żieda fil-piż mil-linja bażi fil-Jum 21) kien ta' 14.1 % għal asenapine 2.5 mg darbtejn kuljum, 8.9 % għal asenapine 5 mg darbtejn kuljum, u 9.2 % għal asenapine 10 mg darbtejn kuljum, meta mqabbel ma' 1.1 % għal plaċebo.
English: Direct glucuronidation (mediated by UGT1A4) and cytochrome P450 (primarily CYP1A2, with contributions of 2D6 and 3A4) mediated oxidation and demethylation are the primary metabolic pathways for asenapine.
Maltese: Glukoronidazzjoni diretta (medjata minn UGT1A4) u ossidazzjoni u demethylation medjati minn ċitokrom P450 (primarjament CYP1A2, b'kontribuzzjonijiet ta' 2D6 u 3A4), huma l-passaġġi metaboliċi primarji għal asenapine.
English: The clinically relevant adverse experiences identified in the paediatric bipolar and schizophrenia trials were similar to those observed in adult bipolar and schizophrenia trials.
Maltese: L-esperjenzi avversi klinikament rilevanti identifikati fil-provi bipolari u ta' skizofrenija pedjatriċi kienu simili għal dawk osservati fil-provi bipolari u ta' skizofrenija tal-adulti.
English: In elderly patients (between 65 and 85 years of age), exposure to asenapine is approximately 30 % higher than in younger adults.
Maltese: F'pazjenti anzjani (li jkollhom bejn 65 u 85 sena), l-espożizzjoni għal asenapine hi ta' madwar 30 % ogħla milli f'persuni adulti żgħażagħ.
English: Asenapine caused mild maternal toxicity and slight retardation of foetal skeletal development.
Maltese: Asenapine ikkawża tossiċità materna ħafifa u dewmien żgħir tal-iżvilupp skeletriku tal-fetu.
English: In clinical trials, the incidence of extrapyramidal symptoms in asenapine-treated patients was higher than placebo (15.4 % vs 11.0 %).
Maltese: Fi provi kliniċi, l-inċidenza ta' sintomi extrapiramidali f'pazjenti kkurati b'asenapine kienet ogħla millplaċebo (15.4 % vs 11.0 %).
English: There was a statistically significant higher incidence of patients with ≥ 7 % weight gain (from baseline to endpoint) compared to placebo (3.1 %) for Sycrest 2.5 mg twice daily (9.5 %) and Sycrest 5 mg twice daily (13.1 %).
Maltese: Kien hemm inċidenza ogħla statistikament sinifikanti ta' pazjenti b'≥ 7 % żieda fil-piż (mil-linja bażi sal-punt ta' tmiem) meta mqabbel mal-plaċebo (3.1 %) għal Sycrest 2.5 mg darbtejn kuljum (9.5 %) u Sycrest 5 mg darbtejn kuljum (13.1 %).
English: Dystonia Akathisia Dyskinesia Parkinsonism Sedation Dizziness Dysgeusia
Maltese: Distonja Akatixja Diskinesija Parkinsoniżmu Sedazzjoni Sturdament Indeboliment fis-Sens tatTogħma
English: Asenapine is cleared primarily through direct glucuronidation by UGT1A4 and oxidative metabolism by cytochrome P450 isoenzymes (predominantly CYP1A2).
Maltese: Asenapine jitneħħa primarjament permezz ta' glukoronidazzjoni diretta minn UGT1A4 u metaboliżmu ossidattiv minn isoenzimi ta' ċitokrom P450 (il-biċċa l-kbira CYP1A2).
English: Asenapine is extensively metabolized.
Maltese: Asenapine jiġi mmetabolizzat b'mod estensiv.
English: EU/1/10/640/001 20 sublingual tablets EU/1/10/640/002 60 sublingual tablets EU/1/10/640/003 100 sublingual tablets
Maltese: EU/1/10/640/001 20 pillola għal taħt l-ilsien EU/1/10/640/002 60 pillola għal taħt l-ilsien EU/1/10/640/003 100 pillola għal taħt l-ilsien
English: Neuroleptic malignant syndrome
Maltese: Sindromu Malinn Newroleptiku
English: Esophageal dysmotility and aspiration have been associated with antipsychotic treatment.
Maltese: L-aspirazzjoni u d-diżmotilità esofagali ġew assoċjati ma' kura antipsikotika.
English: In a population pharmacokinetic analysis, no clinical relevant effects of race on the pharmacokinetics of asenapine were found.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni, ma nstabu l-ebda effetti kliniċi rilevanti li r-razza kellha fuq ilfarmakokinetika ta' asenapine.
English: The intake of water several (2 or 5) minutes after asenapine administration resulted in decreased (19 % and 10 %, respectively) asenapine exposure.
Maltese: It-teħid tal-ilma diversi minuti (2 jew 5) wara l-għoti ta' asenapine, irriżulta fi tnaqqis ta' (19 % u 10 %, rispettivament) fl-espożizzjoni ta' asenapine.
English: Serious hypersensitivity reactions have been reported.
Maltese: Ġew irrapportati reazzjonijiet serji ta' sensittività eċċessiva.
English: All patients met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for bipolar I disorder, current episode manic (DSM-IV 296.4x), or mixed (DSM-IV 296.6x) and had a Young Mania Rating Scale (Y-MRS) score of ≥ 20 at screening and baseline.
Maltese: 4x), jew imħallat (DSM-IV 296.6x) skont il-Manwal Dijanjositku u Statistiku ta' Disturbi Mentali, ir-4 Edizzjoni, u kellhom punteġġ ta' ≥ 20 fuq il-Young Mania Rating Scale (Y-MRS) fl-iscreening u fil-linja bażi.
English: A population pharmacokinetic analysis indicated that there is no evidence of gender-related differences in the pharmacokinetics of asenapine.
Maltese: Analiżi farmakokinetika tal-popolazzjoni indikat li m'hemm l-ebda evidenza ta' differenzi marbuta mas-sess fil-farmakokinetika ta' asenapine.