FrancophonIA/ELRC3.0 huggingface dataset:
English: Drug discrimination studies show that GHB produces a unique discriminative stimulus that in some respects is similar to that of alcohol, morphine and certain GABA-mimetic medicinal products.
Maltese: Studji dwar drug discrimination urew li GHB jipproduċi stimulu uniku u diskriminattiv li f'ċerti aspetti huwa simili għal dak tal-alkoħol, morfina u ċerti prodotti mediċinali li jikkupjaw lil GABA.
English: Sodium oxybate was non-mutagenic and non-clastogenic in in vitro and in vivo assays.
Maltese: Sodium oxybate ma kellux effetti mutaġeniċi u klastoġeniċi f'assays in vitro u in vivo.
English: Gamma Butyrolactone (GBL), a pro-drug of GHB tested at exposures similar to the expected in man (1.21-1.64 times) has been classified by NTP as non-carcinogenic in rats and equivocal carcinogen in mice, due to slight increase of pheochromocytomas which was difficult to interpret due to high mortality in the high dose group.
Maltese: Gamma Butyrolactone (GBL), pro-drug ta' GHB li kien ittestjat f' esponiment simili għal dak mistenni fil-bniedem (1.21-1.64 l-darba) kien ikklassifikat minn NTP bħala mhux karċinoġeniku filfar, minħabba żieda żgħira f' pheochromocytomas li huma diffiċli biex tinterpretahom minħabba lmortalita` għolja fil-grupp tad-doża għolja.
English: If sodium oxybate and valproate are used concomitantly (see section 4.5), a decrease in sodium oxybate dose by 20% is recommended.
Maltese: Jekk sodiun oxybate u valproate jintużaw flimkien (ara sezzjoni 4.5), huwa rrikmandat tnaqqis ta' 20% fid-doża ta' sodium oxybate.
English: - Keep this leaflet.
Maltese: Attakki ta' Kataplessija
English: Sleeping problems including insomnia, blurred vision, feeling the heartbeat, vomiting, stomach pains, diarrhoea, anorexia, decreased appetite, weight loss, weakness, abnormal dreams, tiredness, feeling drunk, sleep paralysis, sleepiness, trembling, confusion/ disorientation, nightmares, sleep walking, bed wetting, sweating, depression, muscle cramps, swelling, fall, joint pain, back pain, excessive daytime sleepiness, balance disorder, disturbance in attention, decreased sensitivity particularly to touch, abnormal touch sensation, feeling of “pins and needles” (part of the body (typically a foot or hand) begins to tingle and becomes numb, or"falls asleep" sedation, abnormal taste, anxiety, difficulty in falling asleep in the middle of the night, nervousness, feeling of “spinning” (vertigo), urinary incontinence, shortness of breath, snoring, congestion of the nose, rash, inflammation of the sinuses, inflammation of nose and throat, increased blood pressure
Maltese: Problemi ta' rqad inkluż insomnja, viżjoni mċajpra, tħoss qalbek tħabbat, rimettar, uġigħ fl-istonku, dijareja, anoressija, nuqqas t'aptit, nuqqas fil-piz, debollezza, ħolm abnormali, għajja, sensazzjoni ta' sakra, paraliżi ta' l-irqad, rogħda, konfużjoni/disorjentazzjoni, inkubi, sonnambuliżmu, tpixxija fissodda, għaraq, waqgħat, uġigħ fil-ġogi,uġigħ fid-dahar, nagħas eċċessiv waqt il-ġurnata, mard talbilanċ, disturbi fl-attenzjoni, tnaqqis fis-sensittivita` partikolarment għal mess, sensazzjoni abnormali tal-mess, sensazzjoni ta' tniggiż (parti mill-ġisem (normalment is-sieq jew l-id) tibda tnemnem u ssir imtarrxa, jew “torqodlok”), sensittivita` mhux normali partikolarment għal mess, sensazzjoni abnormali tal-mess, sedazzjoni, togħma mhux normali, anzjeta`, diffikulta` biex wieħed jorqod f'nofs tal-lejl, nervożita`, tħoss kollox idur bik (vertigo), inkontinenza urinarja, qtuħ ta' nifs, inħir, imnieħer miżdud, raxx, infjammazzjoni tas-sinusis, infjammazzjoni tal-imnieħer u l-gerżuma, żieda fil-pressjoni tad-demm.
English: Table 4 Summary of MWT in Trial 2
Maltese: Skeda 4 Ġabra fil-Qosor ta' MWT f' Prova 2
English: Table 3 Summary of CGI-c in Trial 1
Maltese: Skeda 3 Ġabra fil-Qosor ta' CGI-c f' Prova 1 Impressjonijiet Globali
English: Since sodium oxybate is metabolised by GHB dehydrogenase there is a potential risk of an interaction with medicinal products that stimulate or inhibit this enzyme (e.g. valproate, phenytoin or ethosuximide) (see section 4.4).
Maltese: Peress li sodium oxybate huwa immetabolizzat b' GHB dehydrogenase hemm riskju potenzjali ta' interazzjoni ma' mediċini li jistimulaw jew jinhibixxu dan l-enżim (eż. valproate, phenytoin jew ethosuximide) (ara sezzjoni 4.4).
English: Sodium oxybate, which is as the sodium salt of GHB, is a CNS depressant active substance with wellknown abuse potential.
Maltese: Sodium oxybate li huwa sodium salt ta' GHB, huwa sustanza attiva u depressant tas-sistema nervuża ċentrali li hu magħruf għall-potenzjal għall-abbuż.
English: There have been case reports of dependence after illicit use of GHB at frequent repeated doses (18 to 250 g/day) in excess of the therapeutic dose range.
Maltese: Kien hemm rapporti ta' każi ta' dependenza wara l-użu illeċitu ta' GHB b'dożi frekwenti ripetuti (18 sa 250 g/ġurnata) iżjed mill-marġini tad-dożaġġ terapewtiku.
English: Epworth Sleepiness Scale (ESS; range 0-24) Dose Group [g/d (n)] Baseline
Maltese: Skala ta' Nagħas Epworth (ESS; medda 0-24)
English: Patients being treated with opioids or barbiturates.
Maltese: Pazjenti fuq trattament b'opoids jew barbiturati.
English: The most serious adverse reactions are suicidal attempt, psychosis, respiratory depression and convulsion.
Maltese: L-iżjed reazzjonijiet avversi serji huma attentat ta' suwiċidju, psikożi, depressjoni respiratorja u aċċessjoni.
English: Other medicines and Xyrem
Maltese: Mediċini oħra u Xyrem
English: Administration of sodium oxybate immediately after a high fat meal resulted in delayed absorption (average Tmax increased from 0.75 hr to 2.0 hr) and a reduction in peak plasma level (Cmax) by a mean of 58 and of systemic exposure (AUC) by 37.
Maltese: It-teħid ta' sodium oxybate immedjatament wara ikla għolja fix-xaħam irrisulta f'assorbiment b'dewwmien fl-assorbiment (Tmax medju żdied bejn 0.75 siegħa sa 2.0 siegħat) u t-tnaqqis fl-ogħla livell tal-plażma (Cmax) b'medja ta' 58% u b'esponiment sistemiku (AUC) ta' 37%.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jafftewaw sa 1 minn 100 persuna):
English: Secondary Efficacy Duration Active treatment and Dose (g/d)
Maltese: Trattament Attiv u Doża (g/ġurnata)
English: Reporting of suspected adverse reactions
Maltese: Rapportaġġ tar-reazzjonijiet avversi suspettati
English: Sodium oxybate also has the potential to induce respiratory depression.
Maltese: Sodium oxybate għandu wkoll il-potenzjal li jindotta depressjoni respiratorja.
English: Other neuropsychiatric events include anxiety, psychosis, paranoia, hallucinations, and agitation.
Maltese: Ġrajjiet newropsikjatriċi oħrajn jinkludu anzjeta`, psikożi, paranoja, alluċinazzjonijiet, u aġitazzjoni.
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and diclofenac.
Maltese: Studji fl-interazzjoni tal-mediċini f'adulti b'saħħithom ma wrewx interazzjonijiet bejn sodium oxybate and diclofenac.
English: Table 2 Summary of ESS in Trial 1
Maltese: Skeda 2 Ġabra fil-Qosor ta' ESS f'Prova 1
English: The primary pathway involves a cytosolic NADP+-linked enzyme, GHB dehydrogenase, that catalyses the conversion of sodium oxybate to succinic semialdehyde, which is then biotransformed to succinic acid by the enzyme succinic semialdehyde dehydrogenase.
Maltese: Il-mod primarju jinvolvi enżim li huwa marbut ma' cytosolic NADP+, GHB dehydrogenase, li jikkataliżża l-konverżjoni ta' sodium oxybate f' succinic semialdehyde, li huwa imbagħad bijotrasformat f' succinic acid bl' enżim succinic semialdehyde dehydrogenase.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini (EMEA) http://www.ema.europa.eu/
English: Common: depression, cataplexy, anxiety, abnormal dreams, confusional state, disorientation, nightmares, sleepwalking, sleep disorder, insomnia, middle insomnia, nervousness Uncommon: suicide attempt, psychosis, paranoia, hallucination, abnormal thinking, agitation, initial insomnia
Maltese: Komuni:depressjoni, kataplessija, anzjetà, ħolm abnormali, stat konfużjonali, diżorjentament, ħolm talbiża', sonnambulanza, mard ta' l-irqad, insomnja, insomnja tan-nofs, nervożita` Mhux komuni: attentat ta' suwiċidju, psikożi, paranoja, alluċinazzjonijiet, ħsieb abnormali, aġitazzjoni, attentat ta' suwiċidju, insomnja inizjali
English: Possible pharmacodynamic and pharmacokinetic interactions when sodium oxybate is used concomitantly with topiramate cannot be excluded as clinical observation(s) of coma, and increased plasma GHB concentration were reported in a patient(s) under concomitant use of sodium oxybate and topiramate (section 4.4).
Maltese: Ma jistgħux jiġu esklużi interazzjonijiet farmakodinamiċi u farmakokinetiċi possibli meta sodium oxybate jintuża flimkien ma' topiramate, peress li osservazzjoni(jiet) kliniċi ta' koma, u żieda filkonċentrazzjoni ta' GHB fil-plażma kienu rrappurtati fl-pazjent(i) waqt l-użu flimkien ta' sodium oxybate u topiramate (sezzjoni 4.4).
English: Malic acid for pH adjustment Sodium hydroxide for pH adjustment
Maltese: Malic acid għal aġġustament tal-pH
English: Increased sleepiness was observed after concomitant administration of sodium oxybate (2.25 g) and lorazepam (2 mg).
Maltese: Żieda fin-nagħas kienet osservata wara t-teħid flimkien ta' sodium oxybate (2.25 g) u lorazepam (2 mg).
English: On average, less than 5% of unchanged medicinal product appears in human urine within 6 to 8 hours after dosing.
Maltese: Fil-medda, inqas min 5% tal-prodott mediċinali tidher mhux mibdula fl-awrina fiż-żmien 6 sa 8 sigħat wara d-dożaġġ.
English: Trial 4 enrolled 55 narcoleptic patients who had been taking open-label sodium oxybate for 7 to 44 months.
Maltese: F'prova 4 ħadu sehem 55 pazjenti b'narkolessija li kienu qegħdin jieħdu sodium oxybate f'studju li kien open-label għal 7 sa 44 -ilxahar.
English: Sodium oxybate has been administered concomitantly with CNS stimulant agents in approximately 80% of patients in clinical studies in narcolepsy.
Maltese: Sodium oxybate jittieħdu flimkien ma'mediċini stimulanti tas-CNS f'madwar 80% tal-pazjenti fi studji kliniċi f'narkolessija.
English: Infections and infestations Common: nasopharyngitis, sinusitis
Maltese: Komuni: nażofarinġite, sinusite
English: Approximately 80% of patients who received sodium oxybate during clinical trials maintained CNS stimulant use.
Maltese: Madwar 80% tal-pazjenti li ħadu sodium oxybate waqt il-provi kliniċi baqgħu fuq stimulanti tas-CNS.
English: Convulsion, decreased breathing depth or rate, hives, suicidal thoughts, short cessation of breathing during sleep, euphoric mood, dry mouth, swelling face (angioedema), dehydration, panic attack, mania / bipolar disorder, delusion, bruxism (teeth grinding and jaw clenching), pollakiuria / micturition urgency (increase need to urinate), nocturia (excessive urination at night), tinnitus (noise in the ears such as ringing or buzzing) sleep-related eating disorder, loss of consciousness, increased appetite, irritability, aggression, dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) and thoughts of committing violent acts (including harming others), dandruff and increased sexual desire
Maltese: Aċċessjoni, tnaqqis fil-profondita` jew ir-rata tan-nifs, urtikarja, ħsibijiet ta' suwiċidju, jieqaf in-nifs għal ftit ħin waqt l-irqad, burdata ewforika, ħalq xott, wiċċ minfuħ (anġjoedima), disidrazzjoni, attakk ta' paniku, manija/ mard bipolari, delużjoni, bruxiżmu (tgħeżżiż ta' snin u twebbis tax-xedaq) pollakjurja/ urġenza ta' mikturizzjoni (żieda tal-bżonn biex tagħmel pipi), notturnja (bżonn eċċessiv li tagħmel pipi bil-lejl), tinnitus (ħsejjes fil-widnejn bħal tisfir u tvenvin) , mard tal-ikel relatat mal-irqad, telf ta' koxxenza, żieda fl-aptit, irritibilita`, aggressjoni, diskajnesja (e.ż. movimenti abnormali, mhux ikkontrollati tar-riġlejn u d-dirgħajn) u ħsibijiet li jikkommettu atti vjolenti (inkluż jweġġgħu lil haddieħor), brija u żieda fl-aptit sesswali.
English: Tabulated summary of adverse reactions Undesirable effects are listed according to MedDRA System Organ Class.
Maltese: Sommarju f'tabella tar-reazzjonijiet avversi Effetti mhux mixtieqa kif imliżżla fis-Sistema tal-Klassifikazzjoni tal-Organi
English: Drug interaction studies in healthy adults with sodium oxybate (single dose of 2.25 g) and lorazepam (single dose of 2 mg) and zolpidem tartrate (single dose of 5 mg) demonstrated no pharmacokinetic interactions.
Maltese: Studji fuq l-interazzjoni bejn il-mediċini b'sodium oxybate f'adulti f'saħħithom (doża singola ta' 2.25 g) u lorazepam (doża singola ta' 2 mg) u zolpidem tartrate ( doża singola ta' 5 mg) ma wrew ebda interazzjoni farmakokinetiċi.
English: Trial 3 enrolled 136 narcoleptic patients with moderate to severe cataplexy (median of 21 cataplexy attacks per week) at baseline.
Maltese: F'prova 3 ħadu sehem 136 pazjenti b'narkolessija u b'kataplessija moderata jew severa (medja ta' 21 attakki ta' kataplessija kull ġimgħa) fil-linja bażi.
English: In Trial 4, the response was numerically similar for patients treated with doses of 6 to 9 g/day, but there was no effect seen in patients treated with doses less than 6 g/day.
Maltese: F' prova 4, ir-rispons kien numerikament simili għal pazjenti b'dożi ta' 6 sa 9 g/ġurnata, imma ma kienx hemm effett fil-pazjenti fuq trattament b'dożi inqas minn 6 g/ġurnata.
English: Trial 2 compared the effects of orally administered sodium oxybate, modafinil and sodium oxybate + modafinil, with placebo in the treatment of daytime sleepiness in narcolepsy.
Maltese: F'Prova 2 tqabblu l-effetti ta' sodium oxybate li jittieħed mill-ħalq, modafinil u sodium oxybate + modafinil, mal-plaċebo fit-trattament ta' nagħas bi nhar f'narkolessija.
English: After a single oral dose of 25 mg/kg, AUC values were double in cirrhotic patients, with apparent oral clearance reduced from 9.1 in healthy adults to 4.5 and 4.1 mL/min/kg in Class A (without ascites) and Class C (with ascites) patients, respectively.
Maltese: Wara doża singola orali ta' 25 mg/kg, il-valuri ta' AUC kienu d-doppju f'pażjenti b'ċirrożi, b'clearance orali evidenti li naqas minn 9.1 minn f'adulti f'saħħithom sa 4.5 u 4.1 mL/min/kg f'pazjenti b' Class A (mingħajr axxite) u b' Class C (b'axxite) milli f'pazjenti fil-kontrol ( medja t1/2 ta' ta' 59 u 32 versus 22 minuti).
English: Animal studies indicate that metabolism is the major elimination pathway for sodium oxybate, producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle and secondarily by oxidation.
Maltese: Studji fl-annimali juri li l-mod if jiġi eliminat sodium oxybate huwa l-metaboliżmu, u jipproduċi carbon dioxide u ilma permezz taċ-ċiklu ta' tricarboxylic acid ( Kreb's) u inqas importanti b' ossidazzjoni.
English: Not known: suicidal ideation, homicidal ideation, aggression, euphoric mood, sleep-related eating disorder, panic attack, mania / bipolar disorder, delusion, bruxism, irritability and increased libido
Maltese: Mhux magħruf: ħsibijiet ta' suwiċidju, ħsibijiet ta' qtil, aggressjoni, burdata ewforika, mard tal-ikel relatat mal-irqad, attakki ta' paniku, manija, mard bipolari, delużjoni, bruxiżmu, irritibilita` u żieda ta` libido
English: If you have kidney problems, you should consider a dietary recommendation to reduce sodium intake.
Maltese: Jekk għandek problema fil-kliewi, għandek tikkonsidra ir-rikkmandazzjoni li tnaqqas sodium fid-dieta.
English: Ear and labyrinth disorders Common: vertigo Not known tinnitus
Maltese: Mard tal-widna u s-sistema labirintika Komuni: vertigo
English: UCB Pharma Ltd.
Maltese: United Kingdom UCB Pharma Ltd.
English: GHB had no effect on mating, general fertility or sperm parameters and did not produce embryofoetal toxicity in rats exposed to up 1000 mg/kg/day GHB (1.64 times the human exposure calculated in nonpregnant animals).
Maltese: GHB ma kellux effett fuq tgħammir, fertilita` ġenerali u parametri ta' l-isperma u ma kellux tossiċita` fuq l-embriju u l-fetu f'firien esposti għal mhux iżjed minn 1000 /mg/kg/ġurnata ta' GHB (1.64 ldarba iżjed minn l-esponiment fil-bniedem ikkalkulata f' annimali mhux tqal).
English: Drug interaction studies in healthy adults demonstrated no pharmacokinetic interactions between sodium oxybate and ibuprofen.
Maltese: Studji dwar l-interazzjoni tal-mediċini f'pazjenti adulti b'saħħithom ma wrewx interazzjoni farmakokinetiċi bejn sodium oxybate u ibuprofen.
English: Each mL contains 500 mg of sodium oxybate.
Maltese: Kull mL fih 500 mg ta' sodium oxybate.
English: How to take Xyrem
Maltese: X'fih Xyrem:
English: One bottle of 180 mL oral solution
Maltese: Flixkun wieħed ta' 180 mL soluzzjoni orali
English: UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Somija)
Maltese: UCB Pharma Oy Finland Tel: +358 9 2514
English: Xyrem 500 mg/mL (applies to carton only)
Maltese: INFORMAZZJONI BIL-BRAILLE Xyrem 500 mg/mL (fuq il-kaxxa tal-kartun biss)
English: Sodium Oxybate should not be used during breastfeeding.
Maltese: Sodium oxybate mhux rikkmandat waqt it-tqala.
English: An alternate pathway of biotransformation involves -oxidation via 3,4-dihydroxybutyrate to Acetyl CoA, which also enters the citric acid cycle to result in the formation of carbon dioxide and water.
Maltese: Mod alternattiv ta' bijotrasformazzjoni jinvolvi ossidazzjoni billi jibel 3,4-dihydroxybutyrate f' Acetyl CoA, li ukoll jitħol fiċ-ċiklu tas-citric acid u jirriżulta fil-formazzjoni ta' carbon dioxide u ilma.
English: Tel.: + 48 22 696 99 20
Maltese: UCB Pharma Sp. z o.o. Tel.: + 48 22 696 99 20
English: The co-administration of sodium oxybate (6 g per day) with valproate (1250 mg per day) resulted in an increase in systemic exposure to sodium oxybate by approximately 25% and no significant change in Cmax.
Maltese: It-teħid flimkien ta' sodium oxybate (6g kuljum) b' valproate (1250 mg kuljum) irriżulta f'żieda ta' esponiment sistematiku għal sodium oxybate b' madwar 25% u ebda bidla sinifikanti f' Cmax. Ebda effett fuq il-farmakokinetika ta' valproate ma kien osservat.
English: Patients with porphyria
Maltese: Pazjenti b' porfirja
English: Cases of dependency have occurred after the illicit use of sodium oxybate.
Maltese: Ġraw każi ta' dipendenza wara l-użu illeċitu ta' sodium oxybate.
English: The effectiveness of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group trials (Trial 1, 2, 3 and 4) in patients with narcolepsy with cataplexy except for trial 2 where cataplexy was not required for enrolment Concomitant stimulant use was permitted in all trials (except for the active-treatment phase of Trial 2); antidepressants were withdrawn prior to active treatment in all trials with the exception of Trial 2.
Maltese: L-effettivita` ta' sodium oxybate fit-trattament ta' sintomi ta' narkolessija kienet stabbilita f'erba' provi multiċentrali ta' gruppi paralleli, ikkontrollati mill-plaċebo, double-blind u randomised ( Provi 1, 2,3 u 4) f'pazjenti b'narkolessija u b'kataplessija minbarra prova 2 fejn ma kienx hemm bżonn ilkataplessija għat-tħul fl-istudju.
English: Additionally, randomised, double-blind, placebo-controlled, crossover drug-drug interaction studies with ibuprofen, diclofenac and valproate were performed in healthy subjects and are summarised in section 4.5.
Maltese: Barra minn hekk, studji dwar l-interazzjoni crossover drug-drug, randomizzati, double-blind, ikkontrollati mil plaċebo, b'ibruprofen, diclofenac u valproate saru f'persuni f'saħħithom u huma deskritti fil-qasir f'sezzjoni 4.5.
English: A drug interaction study in healthy adults with sodium oxybate (single dose of 2.25 g) and tramadol (single dose of 100 mg) demonstrated no pharmacokinetic/pharmacodynamic interaction.
Maltese: Studju fuq l-interazzjoni bejn il-mediċini b'sodium oxybate f'adulti f'saħħithom (doża singola ta' 2.25 g) u tramadol (doża singola ta' 100 mg) ma wrew ebda interazzjoni farmakokinetiċi/farmakodinamioċi.
English: • Additional risk minimisation measures The Marketing Authorisation Holder (MAH) shall develop an educational programme for Xyrem to ensure that physicians who intend to prescribe Xyrem are aware about the posology of Xyrem and about the important risks.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Each mL of solution contains 500 mg of sodium oxybate.
Maltese: U KWANTITATTIVA Kull mL ta' soluzzjoni fiha 500 mg ta' sodium oxybate.
English: Sodium oxybate is absorbed rapidly following oral administration with an absolute bioavailability of about 88 %.
Maltese: Assorbiment Sodium oxybate huwa assorbit malajr wara li jittieħed mill-ħalq b'bijodisponibilta` ta' madwar 88 %.
English: When the bottle is delivered, there is a plastic covered foil seal which is on the top of the bottle, underneath the cap. Each pack contains one bottle, a press-in-bottle-adaptor (PIBA), a plastic measuring syringe and two dosing cups with child-resistant caps.
Maltese: Kull kaxxa fiha flixkun wieħed, adapter li jiġi mdaħħal ġol-flixkun (PIBA), siringa tal-kejl tal-plastik u żewġ tazzi għad-dożaġġ b'tappijiet li ma jiftħuhomx it-tfal.
English: No additional effect on sleepiness was observed when comparing single doses of sodium oxybate alone (2.25 g) and sodium oxybate (2.25 g) in combination with duloxetine (60 mg at steady state).
Maltese: Ebda żieda finnagħas ma kienet osservata meta tqabbel doża sinġoli ta' sodium oxybate waħdu (2.25 g) u sodium oxybate (2.25 g) flimkien ma' duloxetine (60 mg fi stat li ma jitbiddilx).
English: There are reports of compromise in the rate and depth of respiration and of life-threatening respiratory depression, necessitating intubation and ventilation.
Maltese: Hemm rapporti ta' kompromess fir-rata u l-fond tar-respirazzjoni kif ukoll ta' depressjoni respiratorja fejn ikun hemm theddida għall-ħajja, tant li kien hemm bżonn ta' intubazzjoni u ventilazzjoni.
English: When higher doses up to 9 g/d of sodium oxybate are combined with higher doses of hypnotics (within the recommended dose range) pharmacodynamic interactions associated with symptoms of CNS depression and/or respiratory depression cannot be excluded (see section 4.3).
Maltese: Meta dożi ogħla sa 9 g/d ta' sodium oxybate jittieħdu flimkien ma' dożi ogħla ta' ipnotiċi (fil-medda tad-dożi rrikkmandati) interazzjoni farmakodinamiċi assoċjati ma' sintomi ta' depressjoni tas-CNS u/jew depressjoni respiratorja ma jistgħux jiġu esklużi (ara sezzjoni 4.3).
English: • medicines that may be processed in a similar way by the body (e.g., valproate, phenytoin or ethosuximide which are used for the treatment of fits)
Maltese: • medicines li jistgħu jkunu proċessati bl-istess mill-ġisem bl-istess mod (eż, valproate, phenytoin jew ethosuximide li jintużaw fit-trattament tal-aċċessjonijiet)
English: Sodium oxybate administered before nocturnal sleep increases Stages 3 and 4 sleep and increases sleep latency, whilst reducing the frequency of sleep onset REM periods (SOREMPs).
Maltese: Sodium oxybate meta jingħata qabel l-irqad ta' bil-lejl iżid l-irqad ta' Stadju 3 u Stadju 4 u jżid l-istadju ta' qabel l-irqad, waqt li jnaqqas il-frekwenza ta' perjodi ta' sleep onset REM (SOREMPs).
English: Given the possibility of increasing the risk of respiratory depression, the concomitant use of benzodiazepines and sodium oxybate should be avoided.
Maltese: Minħabba l-possibillta` li jiżdied ir-riskju ta' depressjoni respiratorja, għandu jiġi evitat l-użu flimkien ta' benzodiazepines u sodium oxybate.
English: Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes (see section 5.2).
Maltese: Studji in vitro b'mikrożomi miġbura tal-fwied uman juru li sodium oxybate ma jinibixxix sinifikament l-attivita` tal-iżoenżimi umani (ara sezzjoni 5.2).