FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4: Baseline demographic characteristics for TRD3002, TRD3001, and TRD3005 (full analysis sets)
Maltese: Tabella 4: Karatteristiċi demografiċi fil-linja bażi għal TRD3002, TRD3001, u TRD3005 (settijiet sħaħ ta' analiżi) Studju TRD3002 (N=223)
English: Other related terms included derealisation (1.9%), depersonalisation (1.7%), illusions (1.5%), and distortion of time (1.2%).
Maltese: Termini oħrajn relatati kienu jinkludu ma tħossx li d-dinja ta' madwarek hija reali (1.9%), ma tħossokx reali (1.7%), illużjonijiet (1.5%), u interpretazzjoni falza tal-ħin (1.2%).
English: ● feeling irritable
Maltese: ● tħossok irritabbli
English: Neuropsychiatric and motor impairments
Maltese: Indebolimenti newropsikjatriċi u motorji
English: The mean steady-state volume of distribution of esketamine administered by the intravenous route is 709 L.
Maltese: Il-medja tal-volum ta' distribuzzjoni fl-istat fiss mogħti mir-rotta ta' ġol-vini hija 709 L.
English: ● Presence or history of psychosis;
Maltese: ● Il-preżenza jew storja ta' psikożi;
English: SD = standard deviation; SE = standard error; LS Mean = least-squares mean; CI = confidence interval; AD = antidepressant
Maltese: SD, standard deviation = devjazzjoni standard; SE, standard error = żball standard; LS Mean = medja ta' least-squares; CI, confidence interval= intervall ta' kunfidenza; AD = antidepressant Esketamine mogħti mill-imnieħer jew plaċebo; AD mill-ħalq= AD mibdi ġdid (SNRI: duloxetine, venlafaxine li jintreħa b'mod estiż;
English: Prior oral antidepressants with nonresponse (i.e., failed antidepressants) Number of specific antidepressants, n (%)
Maltese: Antidepressanti preċedenti mill-ħalq mingħajr rispons (ie., antidepressanti li fallew) Numru ta' antidepressanti speċifiċi, n (%)
English: The terminal half-life of esketamine was similar in the elderly and younger adult subjects (see section 4.2).
Maltese: Il-half-life terminali ta' esketamine kienet tixxiebah fl-individwi anzjani u dawk adulti iżgħar fl-età (ara sezzjoni 4.2).
English: Cognitive and memory impairment
Maltese: Indeboliment kognittiv u tal-memorja
English: Table 2: Recommended dosing for Spravato in adults ≥65 years Induction phase
Maltese: Tabella 2: Għoti tad-doża rrakkomandata għal Spravato f'adulti ≥65 sena Fażi ta' induzzjoni
English: Nervous system disorders dizziness, headache, dysgeusia, somnolence, hypoaesthesia mental impairment, tremor, lethargy, dysarthria, paraesthesia, sedation
Maltese: Disturbi fis-sistema nervuża sturdament, uġigħ ta' ras, disgewżja, ħedla tan-ngħas, ipoestesija indeboliment mentali, rogħda, letarġija, disartrija, parestesija, sedazzjoni
English: ● feeling detached from reality
Maltese: ● tħossok maqtugħ mir-realtà
English: The mean terminal half-life of esketamine in the plasma of Asian subjects ranged from 7.1 to 8.9 hours and was 6.8 hours in Caucasian subjects.
Maltese: Il-medja talhalf-life terminali ta' esketamine fil-plażma ta' individwi Asjatiċi kienet tvarja minn 7.1 sa 8.9 sigħat u kienet 6.8 sigħat f'individwi Kawkasi.
English: The AUC∞ of esketamine was increased by approximately 29%.
Maltese: L-AUC∞ ta' esketamine żdiedet b'madwar 29%.
English: Clinical symptoms are described as convulsions, cardiac arrhythmias, and respiratory arrest.
Maltese: Sintomi kliniċi huma deskritti bħala konvulżjonijiet, arritmiji tal-qalb, u waqfien respiratorju.
English: The terminal half-life of esketamine was not affected by clarithromycin pre-treatment.
Maltese: Il-half-life terminali ta' esketamine ma kinitx affettwata bit-trattament minn qabel bi clarithromycin.
English: Each nasal spray device contains esketamine hydrochloride corresponding to 28 mg esketamine.
Maltese: Kull apparat ta' sprej għall-imnieħer fih esketamine hydrochloride li huwa ekwivalenti għal 28 mg esketamine.
English: ● Repeat Steps 2-5 if more than one device is required.
Maltese: ● Irrepeti Passi 2-5 jekk ikun meħtieġ aktar minn apprat wieħed.
English: The mean esketamine Cmax and AUC∞ values produced by an 84-mg dose were 67% and 38% higher in elderly subjects (age range 75 to 85 years) compared with younger adult subjects (age range 24 to 54 years).
Maltese: Il-medja tal-valuri tas-Cmax u tal-AUC∞ ta' esketamine miksuba bid-doża ta' 84 mg kienu 67% u 38% ogħla f'individwi anzjani (firxa ta' età 75 sa 85 sena) meta mqabbla ma' individwi adulti iżgħar (firxa ta' età minn 24 sa 54 sena).
English: In study TRD3005, at day 28, 64% of the patients randomised to Spravato were on 84 mg, 25% on 56 mg, and 10% on 28 mg.
Maltese: Fl-istudju TRD3005, f'jum 28, 64% tal-pazjenti li ntagħżlu b'mod arbitrarju għal Spravato kienu fuq 84 mg, 25% fuq 56 mg, u 10% fuq 28 mg.
English: Black or African American
Maltese: Suwed jew Amerikani
English: Mean baseline score (SD)
Maltese: Medja talpunteġġ fillinja bażi (SD)
English: The frequency of markedly abnormal blood pressure elevations of SBP (≥40 mmHg increase) ranged from 8% (<65 years) to 17% (≥65 years) and DBP (≥25 mmHg increase) ranged from 13% (<65 years) to 14% (≥65 years) in patients receiving esketamine plus oral antidepressant.
Maltese: Il-frekwenza ta' żidiet kbar mhux normali fil-pressjoni tad-demm tal-SBP (żieda ≥40 mmHg) varjat minn 8% (<65 sena) sa 17% (≥65 sena) u tad-DBP (żieda ≥25 mmHg) varjat minn 13% (<65 years) sa 14% (≥65 years) f'pazjenti li kienu qed jirċievu esketamine flimkien ma' antidepressant mill-ħalq.
English: ● Check that indicator shows 2 green dots.
Maltese: ● Iċċekkja li l-indikatur juri 2 tikek ħodor.
English: Recent (within 6 weeks) cardiovascular event, including myocardial infarction (MI).
Maltese: Każ kardjovaskulari riċenti (fi żmien 6 ġimgħat), li jinkludi infart mijokardjali (MI).
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 hija disponnibbli fuq is-sit sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: Spravato 28 mg, 56 mg or 84 mg + oral AD
Maltese: Spravato 28 mg, 56 mg jew 84 mg + AD mill-ħalq
English: Response was defined as ≥ 50% reduction in the MADRS total score from baseline Remission was defined as MADRS total score ≤ 12
Maltese: Rispons ġie ddefinit bħala tnaqqis ≥ 50% fil-punteġġ totali MADRS mil-linja bażi Remissjoni ġiet iddefinita bħala punteġġ totali MADRS ≤ 12
English: The active substance is esketamine.
Maltese: Is-sustanza attiva hija esketamine.
English: Pre-treatment with oral rifampicin, a potent inducer of the activity of multiple hepatic CYP enzymes such as CYP3A4 and CYP2B6, (600 mg daily for 5 days prior to esketamine administration) decreased the mean Cmax and AUC∞ values of esketamine administered as a nasal spray by approximately 17% and 28%, respectively.
Maltese: Trattament minn qabel b'rifampicin orali, induttur qawwi tal-attività ta' enzimi CYP multipliċi tal-fwied bħal CYP3A4 u CYP2B6, (600 mg kuljum għal 5 ijiem qabel l-għoti ta' esketamine) naqqas il-valuri medji ta' Cmax u AUC∞ ta' esketamine mogħti bħala sprej nażali b'madwar 17% u 28% rispettivament.
English: Spravato contains the active substance esketamine.
Maltese: Spravato fih is-sustanza attiva esketamine.
English: ● Check expiration date (‘EXP').
Maltese: ● Iċċekkja d-data ta' meta jiskadi (‘JIS').
English: No significant differences in the pharmacokinetics of esketamine nasal spray were observed for gender and total body weight (> 39 to 170 kg) based on population PK analysis.
Maltese: Ma kienu osservati l-ebda differenzi sinifikanti fil-farmakokinetika tal-isprej esketamine għallimnieħer għas-sess tal-persuna u l-piż totali tal-ġisem (> 39 sa 170 kg) abbażi ta' analiżi PK ta' popolazzjoni.
English: 2 nasal spray devices 3 nasal spray devices
Maltese: 2 apparati ta' sprej għall-imnieħer 3 apparati ta' sprej għall-imnieħer
English: ● vomiting
Maltese: ● nawsja
English: CARTON (for 1 and 6 nasal spray devices)
Maltese: KARTUNA (għal apparat 1 u 6 apparati ta' sprej għall-imnieħer)
English: SN:
Maltese: Tfn:
English: Spravato doses of 56 mg or 84 mg were fixed in Study TRD3001 and flexible in Study TRD3002.
Maltese: Dożi ta' Spravato ta' 56 mg jew 84 mg kienu fissi fl-Istudju TRD3001 u flessibbli fl-Istudju TRD3002.
English: Oral AD + Placebo Nasal Spray (N=86)
Maltese: AD mill-ħalq + Sprej Plaċebo għallImnieħer (N=86)
English: In clinical studies, Spravato has been reported to cause somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo and anxiety (see section 4.8).
Maltese: Fi studji kliniċi ġie rrappurtat li Spravato jikkkawża ħedla tan-ngħas, sedazzjoni, sintomi ta' disoċċjazzjoni, disturbi talperċezzjoni, sturdament, vertigo u ansjetà (ara sezzjoni 4.8).
English: The AUC∞ was 13 to 36% higher in the subjects with mild to severe renal impairment.
Maltese: L-AUC∞ kienet minn 13 sa 36% ogħla f'individwi b'indeboliment minn ħafif sa moderat tal-kliewi.
English: The proportion of the total concentration of esketamine that is bound to proteins in human plasma is on average 43 to 45%.
Maltese: Il-proporzjon tal-konċnetrazzjoni totali ta' esketamine li tintrabat mal-proteini fil-plażma tal-bniedem hija madwar 43 sa 45%.
English: For patients of Japanese ancestry, initial Spravato dose is 28 mg esketamine (day 1, starting dose, see Table 3).
Maltese: F'pazjenti anzjani d-doża inizjali ta' Spravato hija 28 mg esketamine (doża li tibda biha f'jum 1, ara Tabella 2 fuq).
English: In the flexible dose studies, TRD3002 and TRD3005, up titration of Spravato dose was based on clinical judgement and dose could be down titrated based on tolerability.
Maltese: Fl-istudji b'doża flessibbli, TRD3002 u TRD3005, titrazzjoni 'l fuq tad-doża ta' Spravato kienet ibbażata fuq l-opinjoni klinika u d-doża setgħet tiġi titrata 'l isfel abbażi tat-tollerabilità.
English: Oral AD + Placebo Nasal Spray (N=59)
Maltese: AD mill-ħalq + Sprej Plaċebo għallImnieħer (N=59)
English: ● Stimulants such as those used for conditions such as narcolepsy or medicines for ADHD (for example, amphetamines, methylphenidate, modafanil, armodafinil)
Maltese: ● Stimulanti bħal dawk li jintużaw għal kondizzjonijiet bħal narkolessija jew mediċini għallADHD (per eżempju, amfetamini, methylphenidate, modafanil, armodafinil)
English: In a study of abuse potential conducted in recreational polydrug users (n=41), single doses of esketamine nasal spray (84 mg and 112 mg) and the positive control drug intravenous ketamine (0.5 mg/kg infused over 40 minutes) produced significantly greater scores than placebo on subjective ratings of “drug liking” and on other measures of subjective drug effects.
Maltese: Fi studju tal-potenzjal ta' abbuż li sar f'persuni (n=41) li jużaw ħafna drogi għal rekreazzjoni, dożi waħdiet tal-isprej esketamine għall-imnieħer (84 mg u 112-il mg) u l-mediċina ta' kontroll pożittiv ketamine mill-vini (0.5 mg/kg mogħtija fil-vini fuq perjodu ta' 40 minuta) ipproduċew punteġġi b'mod sinifikanti akbar mill-plaċebo fuq punteġġi suġġettivi ta' “il-mediċina togħġobni” u fuq miżuri oħra ta' effetti suġġettivi tal-mediċina.
English: One device contains 2 sprays (1 spray for each nostril)
Maltese: Apparat wieħed fih 2 sprejs (sprej 1 għal kull minfes)
English: Baseline demographic and disease characteristics for patient in TRD3002, TRD3001, and TRD3005 are presented in Table 4.
Maltese: Karatteristiċi demografiċi u tal-marda fil-linja bażi għal pazjent f'TRD3002, TRD3001, u TRD3005 huma ppreżentati f'Tabella 4.
English: Psychiatric disorders dissociation euphoric mood, agitation, anxiety, illusion, irritability, panic attack, time perception altered, hallucination including visual hallucination, derealisation
Maltese: Disturbi psikjatriċi dissoċjazzjoni burdata ewforika, aġitazzjoni, ansjetà illużjoni, irritabilità, attakk ta' paniku, perċezzjoni mibdula talħin, alluċinazjoni inkluż alluċinażjoni viżwali, ma tħossx li d-dinja ta' madwarek hija reali
English: Table 6: Response and remission rates in 4-week clinical trials based on BOCF data
Maltese: Rati ta' rispons u remissjoni fi provi kliniċi ta' 4 ġimgħat abbażi ta' data BOCF
English: Dose-dependent increases in the maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC∞) of esketamine nasal spray were produced by doses of 28 mg, 56 mg and 84 mg.
Maltese: Żidiet dipendenti fuq id-doża fl-ogħla konċentrazzjoni fil-plażma (Cmax) u l-erja taħt il-kurva ta' konċentrazzjoni fil-plażma mal-ħin (AUC∞) tal-isprej esketamine għall-imnieħer inkisbu bid-dożi 28 mg, 56 mg u 84 mg.
English: ● muscle tremors
Maltese: ● tħossok stordut
English: Esketamine was not mutagenic with or without metabolic activation in the Ames test. Genotoxic effects with esketamine were seen in a screening in vitro micronucleus test in the presence of metabolic activation.
Maltese: Effetti tossiċi fuq il-ġeni b'esketamine dehru f'test screening tal-mikronukleju in vitro fil-preżenza ta' attivazzjoni metabolika.
English: Tell your doctor if you notice any of the following side effects.
Maltese: L-użu ta' Spravato ma' ċerti mediċini jista' jikkawża effetti sekondarji.
English: ● Rest in a comfortable position (preferably, semi-reclined) for 5 minutes after each device.
Maltese: ● Jistrieħ f'pożizzjoni komda (preferibbilment, mimdud ftit lura) għal 5 minuti wara kull apparat.
English: Spravato is available in pack sizes containing 1, 2, 3, or 6 nasal spray devices.
Maltese: Spravato huwa disponibbli f'daqsijiet tal-pakkett li fihom apparat 1, 2, 3, jew 6 apparati ta' sprej għallimnieħer.
English: Through NMDA receptor antagonism, esketamine produces a transient increase in glutamate release leading to increases in α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPAR) stimulation and subsequently to increases in neurotrophic signalling which may contribute to the restoration of synaptic function in these brain regions involved with the regulation of mood and emotional behaviour.
Maltese: Permezz ta' antagoniżmu tar-riċettur ta' NMDA, esketamine jipproduċi żieda temporanja fir-rilaxx tal-glutamate li jwassal għal żidiet fl-istimulu tar-riċettur α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPAR) u sussegwentement għal żidiet fl-għoti ta' sinjali newrotrofiċi li jistgħu jikkontribwixxu għar-ritorn tal-funzjoni tas-sinapsi f'dawn ir-reġjuni tal-moħħ involuti fir-regolazzjoni tal-burdata u tal-komportament emozzjonali.
English: The mean esketamine Cmax and AUC∞ values produced by a 28-mg dose were 21% and 18% higher, respectively, in elderly subjects (age range 65 to 81 years) compared with younger adult subjects (age range 22 to 50 years).
Maltese: Il-medja tal-valuri tas-Cmax u l-AUC∞ ta' esketamine b'doża ta' 28 mg kienu 21% u 18% ogħla, rispettivament, f'individwi anzjani (firxa ta' età bejn 65 u 81 sena) mqabbla ma' individwi adulti iżgħar (firxa ta' età 22 sa 50 sena).
English: Response was defined as ≥ 50% reduction in the MADRS total score from baseline of the induction phase.
Maltese: Rispons ġie ddefinit bħala tnaqqis ≥ 50% fil-punteġġ totali MADRS mil-linja bażi tal-fażi ta' induzzjoni.
English: At the end of the open label induction phase, 52% of patients were in remission (MADRS total score ≤ 12) and 66% of patients were responders (≥ 50% improvement in MADRS total score).
Maltese: MADRS ≤ 12) u 66% tal-pazjenti rrispondew għat-trattament (titjib ≥ 50% fil-punteġġ totali MADRS).
English: Number of patients (%) Response rate
Maltese: Numru ta' pazjenti (%) Rata ta' rispons
English: Dissociation symptoms typically resolved by 1.5 hours post-dose and the severity tended to reduce over time with repeated treatments.
Maltese: Sintomi ta' dissoċjazzjoni b'mod tipiku għaddew wara 1.5 siegħa wara d-doża u l-qawwa tagħhom kellha tendenza li tonqos maż-żmien bi trattamenti ripetuti.
English: ● blurred vision
Maltese: ● vista mċajpra
English: In the cases of sedation, no symptoms of respiratory distress were observed, and haemodynamic parameters (including vital signs and oxygen saturation) remained within normal ranges.
Maltese: F'każijiet ta' sedazzjoni, ma kienu osservati l-ebda sintomi ta' distress respiratorju, u parametri emodinamiċi (inklużi sinjali vitali u saturazzjoni tal-ossiġnu) baqgħu fil-firxa normali.
English: 1 nasal spray device 6 nasal spray devices
Maltese: Apparat 1 ta' sprej għall-imnieħer 6 apparati ta' sprej għall-imnieħer
English: Elderly (65 years of age and older)
Maltese: Anzjani (età ta' 65 sena u aktar)
English: The median time to relapse for a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray group (88 days) was shorter compared to Spravato plus oral AD group (635 days).
Maltese: SSRI: escitalopram, sertraline) flimkien ma' sprej plaċebo għall-imnieħer (88 jum) kien iqsar meta mqabbel mal-grupp ta' Spravato flimkien ma' AD mill-ħalq (635 jum).
English: ● Patients with uncontrolled brady- or tachyarrhythmias that lead to haemodynamic instability;
Maltese: ● Pazjenti b'arritmiji bradi jew taki mhux ikkontrollati li jwasslu għal instabilità emodinamika;
English: Spravato 28 mg nasal spray, solution
Maltese: Spravato 28 mg sprej għall-imnieħer, soluzzjoni
English: Spravato has not been studied in patients with severe hepatic impairment (Child-Pugh class C).
Maltese: Spravato ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (klassi C ta' Child-Pugh).
English: Weeks 5-8: 56 mg or 84 mg once weekly
Maltese: Ġimgħat 5-8: 56 mg jew 84 mg darba fil-ġimgħa
English: Spravato has been reported to cause somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo and anxiety during the clinical trials (see section 4.8).
Maltese: Waqt il-provi kliniċi ġie rrappurat li Spravato jikkawża ħedla tan-ngħas, sedazzjoni, sintomi ta' dissoċjazzjoni, disturbi tal-perċezzjoni, sturdament, vertigo, u ansjetà (ara sezzjoni 4.8).
English: ● Presence or history of mania or bipolar disorder;
Maltese: ● Il-preżenza jew storja ta' manija jew disturb bipolari;
English: Use in this population is not recommended (see sections 4.4 and 5.2).
Maltese: (ara sezzjoni 4.2 u 4.4).
English: Nasal administration of 84 mg esketamine twice a week for 2 weeks reduced the mean plasma AUC∞ of oral midazolam (single 6 mg dose), a substrate of hepatic CYP3A4, by approximately 16%.
Maltese: L-għoti nażali ta' 84 mg esketamine darbtejn fil-ġimgħa għal ġimagħtejn naqqas l-AUC∞ medju ta' midazolam orali fil-plażma (doża waħda ta' 6 mg), sottostrat ta' CYP3A4 tal-fwied, b'madwar 16%.
English: Spravato 28 mg nasal spray, solution esketamine nasal use
Maltese: Spravato 28 mg sprej għall-imnieħer, soluzzjoni esketamine użu għall-imnieħer
English: Pre-treatment with oral clarithromycin, an inhibitor of hepatic CYP3A4 activity, (500 mg twice daily for 3 days prior to and on the day of esketamine administration) increase the mean Cmax and AUC∞ of nasally administered esketamine by approximately 11% and 4%, respectively.
Maltese: Trattament minn qabel bi clarithromycin mill-ħalq, inibitur tal-attività epatika ta' CYP3A4, (500 mg darbtejn kuljum għal 3 ijiem qabel il-jum u fil-jum tal-għoti ta' esketamine) jżid il-medja tas-Cmax u tal-AUC∞ ta' esketamine mogħti mill-imnieħer b'madwar 11% u 4%, rispettivament.
English: Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode (see section 5.1).
Maltese: Spravato, flimkien ma' SSRI jew SNRI, huwa indikat għal adulti b'Disturb Depressiv Qawwi (MDD, Major Depressive Disorder) reżistenti għat-trattament, li ma jkunux irrispondew għal mill-anqas żewġ trattamenti differenti b'antidepressanti waqt l-episodju dipressiv minn moderat sa sever attwali (ara sezzjoni 5.1).
English: Male
Maltese: MIN
English: ● Haemodynamically significant valvular heart disease or heart failure (NYHA Class III-IV).
Maltese: ● Mard tal-qalb valvulari emodinamikament sinjifikanti jew falliment tal-qalb (NYHA Klassi
English: Table 5: Primary efficacy results for change in MADRS total score for 4-week clinical trials (ANCOVA BOCF)
Maltese: Riżultati ta' effikċja primarja għal bidla fil-punteġġ totali MADRS għall-provi kliniċi ta' 4 ġimgħat (ANCOVA BOCF)
English: Of the patients randomised to Spravato, 60% received 84 mg and 40% received 56 mg dose.
Maltese: Mill-pazjenti magħżula b'mod arbitrarju għal Spravato, 60% irċivew doża ta' 84 mg u 40% irċivew 56 mg.
English: Nasal sprays
Maltese: TA' EĊĊIPJENTI
English: For patients in stable response, the relapse rate based on Kaplan-Meier estimates during the 12- and 24-weeks double-blind follow up period was 21% and 21% for Spravato and 47% and 56% for placebo nasal spray, respectively.
Maltese: Għal pazjenti b'rispons stabbli, ir-rata ta' rikaduta fuq l-istimi Kaplan-Meier matul il-perjodu ta' segwitu ta' 12 u 24 ġimgħa fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża kienet 21% u 21% għal Spravato u 47% u 56% għall-isprej plaċebo għall-imnieħer, rispettivament.
English: Hepatotoxicity has been reported with chronic ketamine use, therefore, the potential for such an effect due to long-term use of Spravato cannot be excluded.
Maltese: F'każ ta' doża eċċessiva, għandha titqies il-possibbiltà tal-involviment ta' ħafna prodotti mediċinali.
English: Difference (Spravato + oral AD minus Oral AD + placebo nasal spray) in least-squares mean change from baseline Treatment group that was statistically significantly superior to Oral AD + placebo nasal spray Median unbiased estimate (i.e., weighted combination of the LS means of the difference from Oral AD + placebo nasal spray), and 95% flexible confidence interval
Maltese: Grupp ta' trattament li kien superjuri b'mod sinifikanti għal AD mill-ħalq+ sprej plaċebo għall-imnieħer Medjan ta' stima imparzjali (i.e., kombinazzjoni tal-medji ta' LS tad-differenza minn AD mill-Ħalq+ sprej plaċebo għall-imnieħer mogħtija aktar importanza), u intervall ta' kunfidenza ta' 95% flessibbli
English: ● spinning sensation (“vertigo”)
Maltese: ● sensazzjoni li rasek qed iddur bik (“vertigo”)
English: Ketamine, the racemic mixture of arketamine and esketamine, is a medicinal product that has been reported to be abused.
Maltese: Ketamine, it-taħlita raċemika ta' arketamine u esketamine, huwa prodott mediċinali li ġie rrappuratat li jiġi abbużat.
English: Hepatic impairment
Maltese: Rinite allerġika
English: The primary metabolic pathway of esketamine in human liver microsomes is N-demethylation to form noresketamine.
Maltese: Is-sensiela ta' reazzjonijiet metaboliċi primarji ta' esketamine fil-mikrosomi tal-fwied hija N-demethylation biex jifforma noresketamine.
English: Nasal spray, solution.
Maltese: Sprej għall-imnieħer, soluzzjoni.
English: ● nasal dryness including dry crusts in the nose
Maltese: ● imnieħer xott inkluż qoxra ġol-imnieħer
English: ● feeling dizzy
Maltese: ● imnieħer jieklok
English: Following oral administration of radiolabelled esketamine, approximately 86% and 2% of administered radioactivity was recovered in urine and faeces, respectively.
Maltese: Wara għoti ta' esketamine radjutikkettat mill-ħalq, madwar 86% u 2% tar-radjuattività mogħtija ġiet irkuparata fl-awrina u fl-ippurgar, rispettivament.
English: Stable Responders
Maltese: MANIFATTUR RESPONSABBLI
English: No dose adjustment is necessary in patients with mild (Child Pugh class A) or moderate (Child Pugh class B) hepatic impairment.
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża f'pazjenti b'indeboliment ħafif (klassi A ta' Child Pugh) jew moderat (klassi B ta' Child Pugh) tal-fwied.
English: Subsequent doses should be increased in increments of 28 mg up to 56 mg or 84 mg, based on efficacy and tolerability.
Maltese: Dożi sussegwenti għandhom jiżdiedu bi 28 mg sa 56 mg jew 84 mg, abbażi tal-effikaċja u t-tolerabilità.
English: The terminal half-life of esketamine was not affected by ticlopidine pre-treatment.
Maltese: Il-half life terminali ta' esketamine ma kinitx affettwata bittrattament minn qabel b'ticlopidine.