FrancophonIA/ELRC3.0 huggingface dataset:
English: • A study in 320 patients not controlled with metformin and saxagliptin, showed that adding dapagliflozin to treatment with saxagliptin and metformin reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
Maltese: • Studju fi 320 pazjent mhux ikkontrollati bil-metformina u s-saxagliptin, wera li ż-żieda ta' dapagliflozin mal-kura bis-saxagliptin u l-metformina naqqset il-livelli ta' HbA1c b' 0.8 punti perċentwali meta mqabbla ma' tnaqqis ta' 0.1 punt perċentwali meta plaċebo żdied massaxagliptin u l-metformina.
English: What is the risk associated with Komboglyze?
Maltese: X' inhu r-riskju assoċjat ma' Komboglyze?
English: • A study in 257 patients compared saxagliptin with placebo when added to metformin and a sulphonylurea.
Maltese: • Studju f' 257 pazjent qabbel is-saxagliptin mal-plaċebo meta miżjud mal-metformina u ssulfonilurea.
English: • A study in 315 patients whose blood glucose levels were not satisfactorily controlled with metformin and dapagliflozin showed that adding saxagliptin to dapagliflozin and metformin reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo was added to treatment with dapagliflozin and metformin.
Maltese: • Studju fi 315-il pazjent li l-livelli tal-glukożju f' demmhom ma kinux ikkontrollati b' mod sodisfaċenti bil-metformina u dapagliflozin wera li meta s-saxogliptin żdied ma' dapagliflozin u l-metformina, illivelli ta' HbA1c naqsu b' 0.5 punti perċentwali, meta mqabbla ma' tnaqqis ta' 0.2 punti perċentwali meta plaċebo żdied mal-kura b' dapagliflozin u l-metformina.
English: It must not be used in patients with diabetic ketoacidosis or diabetic pre-coma (a dangerous condition that can occur in diabetes), patients with moderately to severely reduced kidney function or with acute (sudden) conditions which can affect kidney function, patients with diseases which can deprive tissue of oxygen such as heart failure or difficulty breathing, patients with reduced liver function, alcohol poisoning or alcoholism.
Maltese: Ma għandux jintuża minn pazjenti li jbatu mill-ketoaċidożi dijabetika jew millprekoma dijabetika (kundizzjoni perikoluża li tista' sseħħ fid-dijabete), fuq pazjenti b' funzjoni mnaqqsa tal-kliewi minn moderata sa gravi jew li jbatu minn kundizzjonijiet akuti (li jseħħu f' daqqa waħda) li jistgħu jaffettwaw il-funzjoni tal-kliewi, fuq pazjenti li jbatu minn mard li jista' jikkawża nuqqas fit-tessuti tal-ossiġnu bħal insuffiċjenza tal-qalb jew diffikultà fit-teħid tan-nifs, fuq pazjenti bi tnaqqis fil-funzjoni tal-fwied, b' intossikazzjoni alkoħolika jew b' alkoħoliżmu.
English: • A study in 455 patients compared saxagliptin with placebo when added to insulin, with or without metformin.
Maltese: • Studju f' 455 pazjent qabbel is-saxagliptin mal-plaċebo meta miżjud mal-insulina, bil-metformina jew mingħajrha.
English: • One study examined the effects of saxagliptin added to metformin in 160 patients.
Maltese: • Studju wieħed eżamina l-effetti tas-saxagliptin miżjuda mal-metformina f' 160 pazjent.
English: Several studies in patients with type 2 diabetes have shown that the combination of the active substances in Komboglyze, saxagliptin and metformin, is effective in lowering patients' blood glucose.
Maltese: Diversi studji f' pazjenti bid-dijabete tat-tip 2 urew li l-kombinazzjoni tas-sustanzi attivi f' Komboglyze, is-saxagliptin u l-metformina, hija effettiva sabiex tnaqqas il-glukożju fid-demm tal-pazjenti.
English: • A study in 534 patients whose blood glucose levels were not satisfactorily controlled with metformin alone showed that when saxagliptin and dapagliflozin were taken together with metformin, they decreased HbA1c levels by 1.5 percentage points, compared with a reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with dapagliflozin and metformin.
Maltese: huma naqqsu l-livelli ta' HbA1c b' 1.5 punti perċentwali, meta mqabbla ma' tnaqqis ta' 0.9 punti perċentwali bis-saxagliptin u l-metformina u 1.2 punti perċentwali b' dapagliflozin u lmetformina.
English: A reduction of 0.7 percentage points was seen in patients who received saxagliptin, metformin and a sulphonylurea compared with a reduction of 0.1 percentage points in patients who received placebo in place of saxagliptin.
Maltese: Deher li kien hemm tnaqqis ta' 0.7 punti perċentwali f' pazjenti li rċevew issaxagliptin, il-metformina u s-sulfonilurea meta mqabbel ma' tnaqqis ta' 0.1 punt perċentwali f' pazjenti li rċevew il-plaċebo minflok is-saxagliptin.
English: By increasing levels of incretin hormones in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi jżid il-livelli ta' ormoni inkretini fid-demm, is-saxagliptin jistimula lill-frixa biex tipproduċi aktar insulina meta l-livelli ta' glukożju fid-demm ikunu għoljin.
English: • in patients already being treated with saxagliptin and metformin as separate tablets;
Maltese: • f' pazjenti li diġà qed jiġu kkurati b' saxagliptin u bil-metformina bħala pilloli separati;
English: In all the studies the main measure of effectiveness was the reduction in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
Maltese: Fl-istudji kollha, il-kejl ewlieni tal-effikaċja kien it-tnaqqis fil-livelli ta' sustanza msejħa emoglobina glikosilata (HbA1c) fid-demm wara 24 ġimgħa ta' kura.
English: Results showed that in patients taking saxagliptin with metformin HbA1c levels fell by around 0.6 percentage points, compared with a fall of 0.2 percentage points in patients taking placebo (a dummy treatment) with metformin.
Maltese: Ir-riżultati wrew li fil-pazjenti li qed jieħdu s-saxagliptin mal-metformina, il-livelli ta' HbA1c naqsu b' madwar 0.6 punti perċentwali, meta mqabbla ma' tnaqqis ta' 0.2 punt perċentwali f' pazjenti li kienu qed jieħdu plaċebo (kura finta) mal-metformina.
English: If Komboglyze is taken with a sulphonylurea (medicines that make the body produce insulin) or insulin, the dose of these medicines may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Maltese: Jekk Komboglyze jittieħed ma' sulfonilurea (mediċini li jġiegħlu lill-ġisem jipproduċi l-insulina) jew mal-insulina, jista' jkun li ddoża ta' dawn il-mediċini tkun trid titnaqqas, biex tiġi evitata ipogliċemija (livelli baxxi ta' zokkor fiddemm).
English: The active substance metformin works mainly by blocking glucose production and reducing its absorption in the gut.
Maltese: Is-sustanza attiva metformina primarjament taħdem billi timblokka l-produzzjoni tal-glukożju u tnaqqas l-assorbiment tiegħu fil-musrana.
English: HbA1c levels fell by around 0.7 percentage points in patients adding saxagliptin, compared with a fall of around 0.3 percentage points in patients who added placebo.
Maltese: HbA1c naqsu b' madwar 0.7 punti perċentwali f' pazjenti li żiedu ssaxagliptin, meta mqabbla mat-tnaqqis ta' madwar 0.3 punti perċentwali f' pazjenti li żiedu plaċebo.
English: The active substances in Komboglyze, saxagliptin and metformin, work in a different way to help reduce blood glucose levels and control type 2 diabetes.
Maltese: Is-sustanzi attivi f' Komboglyze, is-saxagliptin u l-metformina jaħdmu b' mod differenti biex jgħinu fit-tnaqqis tal-livelli ta' glukożju fid-demm u jikkontrollaw id-dijabete tat-tip 2.
English: How does Komboglyze work?
Maltese: Kif jintuża Komboglyze?
English: For the full list of all side effects reported with saxagliptin and metformin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bis-saxagliptin u bil-metformina, ara l-fuljett ta' tagħrif.
English: How is Komboglyze used?
Maltese: Kif jaħdem Komboglyze?
English: Komboglyze is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes to improve control of blood glucose (sugar) levels.
Maltese: Komboglyze huwa mediċina kontra d-dijabete li tintuża flimkien ma' dieta u eżerċizzju għall-kura ta' adulti b' dijabete tat-tip 2 sabiex ittejjeb il-kontroll tal-livelli tal-glukożju (zokkor) fid-demm.
English: Saxagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Is-saxagliptin tnaqqas ukoll l-ammont ta' glukożju prodott mill-fwied, billi żżid illivelli ta' insulina u tnaqqas il-livelli tal-ormon glukagon.
English: Results showed that adding saxagliptin to metformin was effective in lowering HbA1c levels.
Maltese: Ir-riżultati wrew li ż-żieda tas-saxagliptin mal-metformina kienet effettiva sabiex il-livelli ta' HbA1c jonqsu.
English: 3 vial + 3 vials powder: vial (glass); solvent: vials (glass)
Maltese: 1 kunjett + 1 kunjett trab: kunjett (ħġieġ); solvent: kunjetti (ħġieġ)
English: 1 vial + 1 ampoule
Maltese: 1 kunjett + 1 ampulla
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Maltese: Numru tal-UE Isem ivvintat Qawwa Għamla farmaċewtika
English: 4.3 Contra-indications
Maltese: Kontraindikazzjonijiet
English: Haldol Decanoate and associated names (such as Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat, and Serenase Depot) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Sweden and United Kingdom, and in Iceland and Norway.
Maltese: Haldol Decanoate u ismijiet assoċjati (bħal Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat, u Serenase Depot) jitqiegħdu fis-suq fl-Awstrija, il-Belġju, Ċipru, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Lussemburgu, in-Netherlands, in-Norveġja, il-Portugall, l-Iżvezja u r-Renju Unit, kif ukoll flIżlanda u n-Norveġja.
English: The European Commission issued a decision on this opinion on 28/04/2017.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fi 28/04/2017.
English: On 23 February 2017, the European Medicines Agency completed a review of Haldol Decanoate.
Maltese: Fit-23 ta' Frar 2017, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Haldol Decanoate.
English: What is Haldol Decanoate?
Maltese: X'inhu Haldol Decanoate?
English: The CHMP harmonised other sections of the SmPC including interactions between Haldol Decanoate and other medicines (section 4.5), as well as information on pregnancy, lactation and fertility (section
Maltese: Is-CHMP armonizza sezzjonijiet oħra tal-SmPC inkluż interazzjonijiet bejn Haldol Decanoate u mediċini oħra (sezzjoni 4.5), kif ukoll informazzjoni dwar it-tqala, it-treddigħ u l-fertilità (sezzjoni 4.6).
English: Haldol Decanoate is authorised in the EU via national procedures.
Maltese: Haldol Decanoate huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: It contains the active ingredient haloperidol decanoate.
Maltese: Dan fih is-sustanza attiva haloperidol decanoate.
English: Haldol Decanoate is an antipsychotic medicine used for schizophrenia and schizoaffective disorder (schizophrenia with mood disorders), which are mental disorders that affect how the person thinks, feels or behaves.
Maltese: Haldol Decanoate huwa mediċina antipsikotika li jintuża għal skizofrenija u disturb skizoaffettiv (skizofrenija b'disturb fil-burdati), li huma disturbi mentali li jaffettwaw kif persuna taħseb, tħossha jew iġġib ruħha.
English: The CHMP agreed to harmonisation of Haldol Decanoate's contra-indications.
Maltese: Is-CHMP qabel fuq armonizzazzjoni tal-kontraindikazzjonijiet ta' Haldol Decanoate.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol Decanoate in the European Union (EU).
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Haldol Decanoate fl-Unjoni Ewropea (UE).
English: The CHMP agreed that Haldol Decanoate injection can be used for the continuing treatment of schizophrenia and schizoaffective disorder in adults who have been on a stable dose of haloperidol by mouth.
Maltese: Is-CHMP qabel li injezzjoni ta' Haldol Decanoate tista' tintuża għall-kura kontinwa ta' skizofrenija u disturb skizoaffettiv fl-adulti li kienu fuq doża stabbli ta' haloperidol mill-ħalq.
English: On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol Decanoate and associated names in the EU.
Maltese: Fit-18 ta' Ġunju 2014, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Haldol Decanoate u ismijiet assoċjati fl-UE.
English: Haldol Decanoate was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Haldol Decanoate ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: The companies that market these medicines include Janssen-Cilag Ltd and associated companies.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Janssen-Cilag Ltd u kumpaniji assoċjati.
English: The CHMP harmonised the SmPC to include information on when Haldol Decanoate's side effects on movement might appear, details on mortality in the elderly, and effects on the heart and the brain.
Maltese: Is-CHMP armonizza l-SmPC biex jinkludi informazzjoni dwar meta jistgħu jidhru l-effetti sekondarji ta' moviment b'Haldol Decanoate, dettalji dwar il-mortalità fl-anzjani u l-effetti fuq il-qalb u l-moħħ.
English: Haldol Decanoate is given by injection into the muscle usually every 4 weeks, to patients who have been taking haloperidol by mouth.
Maltese: Haldol Decanoate jingħata b'injezzjoni ġol-muskolu normalment kull 4 ġimgħat, lil pazjenti li kienu qed jieħdu haloperidol mill-ħalq.
English: It is also available in the EU as generic haloperidol decanoate.
Maltese: Dan huwa disponibbli wkoll flUE bħala haloperidol decanoate ġeneriku.
English: In particular, Haldol Decanoate must not be used in patients with heart disorders such as certain heart-rhythm problems, heart failure and recent heart attack, and with central nervous depression (reduced brain activity that slows down breathing and heart rate and reduces alertness).
Maltese: B'mod partikolari, Haldol Decanoate m'għandux jintuża f'pazjenti b'disturbi tal-qalb bħal ċerti problemi fir-ritmu tal-qalb, b'insuffiċjenza tal-qalb u li kellhom attakk tal-qalb riċenti, u b'dipressjoni nervuża ċentrali (attività talmoħħ imnaqqsa li tmajna n-nifs u r-rata tal-qalb u tnaqqas l-allert).
English: Responders* N (%)
Maltese: Minn Irrisponda* N (%)
English: Trial 2 EDS (MWT)
Maltese: Prova 2 EDS (MWT)
English: Placebo (60)
Maltese: Plaċebo (60)
English: No data are available.
Maltese: M'hemmx dejta disponibli.
English: Trial 1 EDS (ESS); CGIc
Maltese: Prova 1 EDS (ESS); CGIc
English: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom.
Maltese: UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, Renju Unit.
English: Placebo 3.0 g/day 6.0 g/day 9.0 g/day
Maltese: 3.0 g/ġurnata 6.0 g/ġurnata 9.0 g/ġurnata day 33
English: • topiramate (used for treatment of epilepsy)
Maltese: • topiramate (li jintuża fit-trattament tal-epilessija)
English: Respiratory and CNS depression
Maltese: Depressjoni respiratorja u tas-CNS
English: • Alcohol and CNS depressants
Maltese: • Alkoħol u depressanti tas-CNS
English: Frequency estimate: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Estimu tal-frekwenza: komuni ħafna (≥ 1/10); komuni (≥ 1/100 to < 1/10); mhux komuni (≥ 1/1000 to < 1/100); rari (≥ 1/10,000 to < 1/1000); rari ħafna (< 1/10,000); mhux magħruf (ma jistax jitkejjel mittagħrif miġbur).
English: Xyrem 500 mg/mL oral solution
Maltese: Xyrem 500 mg/mL soluzzjoni orali
English: GHB dehydrogenase inhibitors
Maltese: Inhibituri ta' GHB dehydrogenase
English: Patients with succinic semialdehyde dehydrogenase deficiency.
Maltese: Pazjenti b'defiċjenza ta' succinic semialdehyde dehydrogenase.
English: B-1420 Braine l'Alleud,
Maltese: Braine l'Alleud,
English: Sodium oxybate is a hydrophilic compound with an apparent volume of distribution averaging 190384 mL/kg.
Maltese: Sodium oxybate huwa sustanza idrofilika li għandha volum ta' distribuzzjoni evidenti ta' medja bejn il-190-384 mL/kg.
English: Sodium oxybate is the sodium salt of GHB.
Maltese: Sodium oxybate huwa s-sodium salt ta' GHB.
English: Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes: CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 µg/mL).
Maltese: Studji in vitro b' mikrożomi miġbura minn fwied uman juru li sodium oxybate ma jinibixxix b'mod sinifikanti l-attivita` ta' iżoenżimi umani: : CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, jew CYP3A sa konċentrazzjoni ta' 3 mM (378 g/mL).
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussel, Il-Belġju.
English: Sodium oxybate undergoes significant presystemic (hepatic first-pass) metabolism.
Maltese: Sodium oxybate tiġi metabolizzata sinifikament qabel ma jidħol fiċ-ċirkolazzjoni tad-demm (hepatic first-pass).
English: Date for first authorisation: 13 October 2005 Date of latest renewal: 08 September 2015
Maltese: Data ta' l-aħħar tiġdid: 08 Settembru 2015
English: Cardiac disorders Common: palpitations
Maltese: Komuni: palpitazzjonijiet
English: The discontinuation effects of sodium oxybate have not been systematically evaluated in controlled clinical trials (see section 4.4).
Maltese: L-effetti ta' meta jitwaqqaf sodium oxybate ma kienux sistematikament evalwati f' provi kliniċi kontrollati (ara sezzjoni 4.4).
English: Trial 4 Cataplexy
Maltese: Prova 4 Kataplessija
English: • medicines that increase central nervous system activity and antidepressants
Maltese: • medicini li jżidu l'attivita' tas-sistema ċentrali nervuża u antidepressanti
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ benefiċċju/riskju tal-prodott mediċinali.
English: UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848
Maltese: Deutschland UCB Pharma GmbH Tel: + 49 (0)2173 48 4848
English: 246 MWT/Sleep Architecture/ Cataplexy/Naps/FOSQ
Maltese: MWT/Struttura ta' L'Irqad/ Kataplessija /Naps/FOSQ
English: Immune system disorders Uncommon: hypersensitivity
Maltese: Mard tas-sistema immuni: Mhux komuni: ipersensitivita`
English: Sedative hypnotics
Maltese: Ipnotiċi sedattivi
English: Myoclonus and tonic-clonic seizures have been reported.
Maltese: Kienu rapportati aċċessjonijiet tat-tip myoclonus u tonic-clonic.
English: Treatment of narcolepsy with cataplexy in adult patients.
Maltese: It-trattament ta' narkolessija b'kataplessija f'pazjenti adulti.
English: Xyrem contains sodium
Maltese: Xyrem fiħ sodium
English: Xyrem 500 mg/mL oral solution Sodium oxybate
Maltese: Xyrem 500 mg/mL soluzzjoni orali Sodium oxybate
English: Data from a limited number of pregnant women exposed in the first trimester indicate a possible increased risk of spontaneous abortions.
Maltese: Dejta minn numru limitat ta' nisa tqal li ġew esposti fl-ewwel trimester juri l-possibilta` ta' żieda firriskju ta' abort spontanju.
English: Trial 3 Cataplexy
Maltese: Prova 3 Kataplessija
English: Xyrem contains the active substance sodium oxybate.
Maltese: - Is-sustanza attiva hi sodium oxybate.
English: In a limited number of patients greater than the age of 65 years the pharmacokinetics of sodium oxybate was not different compared to patients younger than 65 years of age.
Maltese: F'numru limitata ta' pazjenti t'eta` akbar minn 65 sena il-farmakokinetika ta' sodium oxybate ma kinitx differenti meta mqabbla ma dik f'pazjenti iżgħar minn 65 sena.
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jġorr l-identifikatur uniku inkluż.
English: Clinical Global Impressions of Change (CGI-c) Dose Group [g/d (n)]
Maltese: Kliniċi ta' Bidla (CGI-c) Grupp ta' Doża [g/ġurnata (n)]
English: Xyrem has the potential to induce respiratory depression
Maltese: Xyrem għandu l-potenzjal li jindotta depressjoni respiratorja.
English: There is no clinical data available on the effect of sodium oxybate on fertility.
Maltese: M'hemmx dejta klinika disponibbli dwar l-effetti ta' sodium oxybate fuq il-fertilità.
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX04.
Maltese: Mediċinali oħra tas-Sistema Nervuża, Kodiċi ATC:
English: A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyses the conversion to succinic semialdehyde in the presence of -ketoglutarate.
Maltese: Enżim tal-mitokondrion oxidoreductase ieħor, li hu transhydrogenase, jikkatalizza ukoll il-konverżjoni f' succinic semialdehyde fil-preżenza ta' -ketoglutarate.
English: Succinic acid enters the Krebs cycle where it is metabolised to carbon dioxide and water.
Maltese: Succinic acid jitħol fil-Krebs cycle fejn jiġi metaboliżżat f'carbon dioxide u ilma.
English: TRIAL 2
Maltese: PROVA 2
English: Take doses within 24 hours after preparation.
Maltese: Hu d-dożi sa 24 siegħa wara l-preparazzjoni.
English: • Gamma hydroxybutyrate (GHB) dehydrogenase inhibitors Caution is required in patients who are treated concomitantly with valproate or other GHB dehydrogenase inhibitors as pharmacokinetic and pharmacodynamic interactions have been observed when sodium oxybate is co-administered with valproate (see section 4.5).
Maltese: • Inhibituri ta' Gamma hydroxybutyrate (GHB) dehydrogenase Trid tittieħed attenzjoni f' pazjenti li huma trattati fl-istess ħin b' valproate jew xi inhibitur ta' GHB dehydrogenase ieħor għaliex ġew osservati interazzjonijiet farmakokinetiċi u farmakodinamiċi meta sodium oxybate jingħata flimkien ma' valproate (ara sezzjoni 4.5).
English: At sodium oxybate concentrations ranging from 3 to 300 µg/mL, less than 1% is bound to plasma proteins.
Maltese: F'konċentrazzjonijiet ta' sodium oxybate f'medda ta' 3 sa 300 g/mL, inqas minn 1% huwa marbut mal-proteini tal-plażma.
English: Two Phase 3 and one Phase 2 double-blind, parallel-group, placebo-controlled studies were performed to assess the indication of sodium oxybate for fibromyalgia.
Maltese: Żewġ studji ta' Fażi 3 u studju wieħed f'Fażi 2 double-blind, fi grupp paralleli, ikkontrollati mil plaċebo saru biex jeżaminaw l-indikazzjoni ta' sodium oxybate ghal fibromyalgia.
English: Major depression is contraindicated for use with Xyrem (section 4.3).
Maltese: Id-depressjoni maġġuri hija kontraindikata fl-użu ta' Xyrem (sezzjoni 4.3).
English: EDS - Excessive daytime sleepiness; ESS - Epworth Sleepiness Scale; MWT - Maintenance of Wakefulness Test; Naps - Number of inadvertent daytime naps; CGIc - Clinical Global Impression of Change; FOSQ - Functional Outcomes of Sleep Questionnaire
Maltese: EDS - nagħas ta' bi nhar eċċessiv; ESS - skala tan-nagħas Epworth; MWT - Test ta' kemm iżżomm imqajjem; Naps - Numru ta' nagħsiet involontarji ta' bi nhar; CGIc -L-Impressjoni Globali
English: Sleep Architecture/ ESS/CGIc/Naps
Maltese: Struttura ta' L'Irqad/ ESS/CGIc/Naps
English: Allée de la Recherche 60 B-1070 Brussels Belgium
Maltese: B-1070 Brussel Il-Belġju
English: - The other ingredients are purified water, malic acid and sodium hydroxyde.
Maltese: - Is-sustanzi l-oħra huma ilma purifikat, malic acid u sodium hydroxide.