FrancophonIA/ELRC3.0 huggingface dataset:
English: It is intended for administration by the patient under the supervision of a healthcare professional, using 1 device (for a 28 mg dose), 2 devices (for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of each device.
Maltese: Huwa maħsub biex jingħata mill-pazjent taħt is-superviżjoni ta' professjoniist tal-kura tas-saħħa, bl-użu ta' apparat 1 (għal doża ta' 28 mg), 2 apparati (għal doża ta' 56 mg) jew 3 apparati (għal doża ta' 84 mg), b'waqfa ta' 5 minuti bejn użu ta' apparat u ieħor.
English: Dissociation (26%) was one of the most common psychological effects of esketamine.
Maltese: Dissoċjazzjoni (26%) kienet waħda mill-effetti fiżjoloġiċi l-aktar komuni ta' esketamine.
English: A newly initiated open-label oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) was initiated on day 1 in all studies.
Maltese: SSRI: escitalopram, sertraline) inbeda f'jum 1 fl-istudji kollha.
English: Table 3: Recommended Dosing for Spravato in Adults of Japanese Ancestry Induction phase
Maltese: Tabella 3: Dożaġġ Rakkomandat għal Spravato f'Adulti ta' Nisel Ġappuniż Fażi ta' induzzjoni
English: In study TRD3002, esketamine plus a newly initiated oral AD demonstrated clinically meaningful and statistical superiority compared to a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Table 5), and symptom reduction was observed as early as 24 hours post-dose.
Maltese: Fl-istudju TRD3002, esketamine flimkien mal-AD mill-ħalq mibdi ġdid urew superjorità ta' sinifikat kliniku u statistika meta mqabbla mal-AD mill-ħalq mibdi ġdid (SNRI: duloxetine, venlafaxine li jintreħa b'mod estiż;
English: In individuals who were dependent on ketamine, withdrawal symptoms of cravings, anxiety, shaking, sweating and palpitations have been reported upon discontinuing ketamine.
Maltese: F'individwi li kienu dipendenti fuq il-ketamine, sintomi ta' twaqqif ta' mediċina li tivvizzja ta' xenqa, ansjetà, tregħid, ħruġ ta' għaraq u palpitazzjonijiet ġew irrappurtati mat-twaqqif tal-ketamine.
English: Nasally administered Spravato or placebo; oral AD = a newly initiated AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline)
Maltese: Spravato jew plaċebo mogħtija mill-imnieħer; AD mill-ħalq=AD mibdi ġdid (SNRI: duloxetine, venlafaxine li jinterħa b'mod estiż;
English: Sedative effects typically resolved by 1.5 hours post-dose.
Maltese: Effetti sedattivi b'mod tipiku għaddew 1.5 sigħat wara d-doża.
English: Renal impairment
Maltese: Rispons stabbli
English: Hepatic enzyme inhibitors
Maltese: Ilma għall-injezzjonijiet
English: Nasal administration of 84 mg esketamine twice a week for 2 weeks did not affect the mean plasma AUC of oral bupropion (single 150 mg dose), a substrate of hepatic CYP2B6.
Maltese: l-għoti nażali ta' 84 mg ta' esketamine darbtejn fil-ġimgħa għal ġimagħtejn ma affettwax l-AUC medju ta' bupropion orali fil-plażma (doża waħda ta' 150 mg), sottostrat ta' CYP2B6 tal-fwied.
English: Study SUSTAIN-1 (TRD3003) was a long-term randomised, double-blind, parallel-group, active-controlled, multicenter, relapse prevention study.
Maltese: L-Istudju SUSTAIN-1 (TRD3003) kien studju fit-tul, arbitrarju, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża bi grupp parallell, ikkontrollat b'mod attiv, b'ħafna ċentri dwar prevenzjoni ta' rikaduta.
English: • In patients with clinically significant or unstable cardiovascular or respiratory conditions, SPRAVATO should be administered in a clinical setting where equipment for cardiopulmonary resuscitation and staff trained in cardiopulmonary resuscitation are available;
Maltese: • F'pazjenti b'kundizzjonijiet kardjovaskulari jew respiratorji klinikament sinjifikanti jew instabbli, SPRAVATO għandu jingħata f'ambjent kliniku fejn tagħmir għal risuxxitazzjoni kardjopulmonari u personel mħarreġ fir-risuxxitazzjoni kardjopulmonari huma disponibbli;
English: For patients in stable remission, the relapse rate based on Kaplan-Meier estimates during the 12- and 24-weeks double-blind follow up period was 13% and 32% for Spravato and 37% and 46% for placebo nasal spray, respectively.
Maltese: Għall-pazjenti b'remissjoni stabbli, ir-rata ta' rikaduta abbażi tal-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 13% u 32% għal Spravato u 37% u 46% għall-isprej plaċebo għall-imnieħer. rispettivament.
English: 24 hours Week 1 Week 2 Week 3 Week 4 Week 4
Maltese: 24 siegħa Ġimgħa 1 Ġimgħa 2 Ġimgħa 3 Ġimgħa 4 Ġimgħa 4
English: Subgroup analyses suggest limited efficacy in the population over 75 years old.
Maltese: Analiżi ta' sottogrupp tissuġġerixxi effikaċja limitata fil-popolazzjoni ta' persuni li għandhom aktar minn 75 sena.
English: Respiratory, thoracic and mediastinal disorders nasal discomfort, nasal dryness including nasal crusting, nasal pruritus
Maltese: Disturbi respiratorji, toraċiċi u medjastinali skumdità fl-imnieħer, imnieħer xott inkluż qoxra ġol-imnieħer, ħakk fl-imnieħer
English: In the flexible dose study TRD3002, at day 28, 67% of the patients randomised to Spravato were on 84 mg.
Maltese: Fl-istudju b'doża flessibbli TRD3002, f'jum 28, 67% tal-pazjenti li ntagħżlu b'mod arbitrarju għal Spravato kienu fuq 84 mg.
English: Concomitant use of Spravato with CNS depressants may increase the risk for sedation (see section 4.5).
Maltese: Spravato għandu jingħata jekk żieda fil-pressjoni tad-demm jew fil-pressjoni intrakranjali jkunu ta' riskju serju (ara sezzjoni 4.3).
English: Oral AD + placebo nasal spray
Maltese: AD mill-ħalq + sprej plaċebo għall-imnieħer
English: 56 mg + oral AD Spravato
Maltese: 56 mg + AD millħalq
English: ● feeling sleepy
Maltese: ● żieda fil-bżieq
English: Prior to the launch of SPRAVATO in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials (EM) and the controlled access programme (CAP), including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Maltese: Qabel it-tnedija ta' SPRAVATO f'kull Stat Membru (SM), id-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAH, Marketing Authorisation Holder) għandu jaqbel fuq il-kontenut u l-format ta' materjal edukattv u programm ta' aċċess ikkontrollat, inkluż il-mezzi ta' komunikazzjoni, il-modi ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm mal-Awtorità Nazzjonali Kompetenti.
English: The efficacy and safety of Spravato nasal spray was investigated in five Phase 3 clinical studies in adult patients (18 to 86 years) with treatment-resistant depression (TRD) who met DSM-5 criteria for major depressive disorder and were non-responders to at least two oral antidepressants (ADs) treatments, of adequate dosage and duration, in the current major depressive episode.
Maltese: L-effikaċja u s-sigurtà tal-isprej għall-imnieħer Spravato ġew investigati f'ħames studji kliniċi ta' Fażi 3 f'pazjenti adulti (18 sa 86 sena) b'depressjoni reżistenti għat-trattament (TRD, treatment-resistant depression) li ssodisfaw il-kriterji DSM-5 għal disturb depressiv qawwi u ma kinux irrispondew għal trattament b'mill-anqas żewġ antidepressanti mill-ħalq (ADs, antidepressants), b'doża xierqa u tul ta' żmien xieraq, matul l-episodju depressiv qawwi attwali.
English: The Cmax and AUC∞ of esketamine produced by a 28-mg doses were similar between subjects with Child-Pugh class A (mild) hepatic impairment and healthy subjects.
Maltese: Is-Cmax u l-AUC∞ ta' esketamine miksuba b'doża ta' 28 mg kien jixxiebah bejn individwi b'indeboliment tal-fwied tal-klassi A ta' Child-Pugh (ħafif) u individwi f'saħħithom.
English: Dissociation was reported as severe in intensity at the incidence of less than 4% across studies.
Maltese: Dissoċjazzjoni ġiet irrappurtata bħala severa fl-intensità bl-inċidenza ta' inqas minn 4% fl-istudji kollha.
English: ● One nasal spray device delivers two sprays (one spray per nostril)
Maltese: ● tħossok ferħan b'mod estrem (“ewforja”)
English: Following intravenous administration of radiolabelled esketamine, approximately 78% and 2% of administered radioactivity was recovered in urine and faeces, respectively.
Maltese: Wara għoti ta' esketamine radjutikkettat minn ġol-vini, madwar 78% u 2% tar-radjuattività mogħtija ġiet irkuprata mill-awrina u mill-ippurgar, rispettivament.
English: Noresketamine is subsequently metabolised via CYP-dependent pathways to other metabolites, some of which undergo glucuronidation.
Maltese: Sussegwentement noresketamine jiġi metabolizzat permezz ta' sensiela ta' reazzjonijiet dipendenti fuq CYP f'metaboliti oħra, li xi wħud minn jgħaddu minn glukuronidazzjoni.
English: Treatment-resistant depression - Short-term studies
Maltese: Depressjoni reżistenti għat-trattament - Studji fit-tul
English: Allergic rhinitis
Maltese: Nru talIstudju
English: The recovered radioactivity consisted primarily of esketamine metabolites.
Maltese: Ir-radjuattività irkuprata kienet tikkonsisti l-aktar fil-metaboliti ta' esketamine.
English: How to use Spravato
Maltese: X'inhu Spravato
English: Spravato (28 mg, 56 mg or
Maltese: Spravato (28 mg, 56 mg jew 84 mg) + AD millħalq
English: ● ever had an overactive thyroid that is not properly treated (hyperthyroidism)
Maltese: ● qatt kellek glandola t-tirojde attiva ħafna li ma ġietx trattata kif suppost (ipertirojdiżmu)
English: Women of childbearing potential
Maltese: Potenzjal għal abbuż
English: The increase in Cmax and AUC values was less than dose-proportional between 28 mg and 56 mg or 84 mg, but it was nearly dose proportional between 56 mg and 84 mg.
Maltese: Iż-żieda fil-valuri tasCmax u tal-AUC kienet inqas minn dik fi propozjon mad-doża bejn 28 mg u 56 mg jew 84 mg, iżda kienet kważi fi proporzjon mad-doża bejn 56 mg u 84 mg.
English: total score ≤ 12 in at least 3 of the last 4 weeks of the optimisation phase and stable response was defined as ≥ 50% reduction in the MADRS total score from baseline for the last 2 weeks of the optimisation phase, but not in stable remission.
Maltese: Remissjoni stabbli ġiet iddefinita bħala punteġġ totali MADRS ≤ 12 f'mill-inqas 3 mill-aħħar 4 ġimgħat tal-fażi ta' ottimizzazzjoni u rispons stabbli kien ddefinit bħala tnaqqis ta' ≥ 50% fil-punteġġ totali MADRS mil-linja bażi għall-aħħar ġimagħtejn tal-fażi ta' ottimizzazzjoni, iżda mhux f'remissjoni stabbli.
English: Life-threatening symptoms are expected based on experience with ketamine given at 25-fold the usual anaesthetic dose.
Maltese: Sintomi ta' periklu għall-ħajja huma mistennija abbażi ta' esperjenza b'ketamine mogħti 25 darba aktar mid-doża tas-soltu tal-anestesija.
English: Type-I glass vial with a chlorobutyl rubber stopper.
Maltese: Kunjett tal-ħġieġ tat-Tip-I b'tapp tal-lastku chlorobutyl rubber.
English: Spravato 56 mg or 84 mg + oral AD
Maltese: Spravato (56 mg jew 84 mg) + AD millħalq
English: Patients in stable remission who continued treatment with Spravato plus oral AD experienced a statistically significantly longer time to relapse of depressive symptoms than did patients on a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Figure 1).
Maltese: Pazjenti f'remissjoni stabbli li komplew it-trattament bi Spravato flimkien ma' AD mill-ħalq kellhom ħin itwal sinifikanti b'mod statistiku għar-rikaduta ta' sintomi depressivi milli kellhom pazjenti fuq AD mill-ħalq mibdi ġdid (SNRI: duloxetine, venlafaxineli jintreħa b'mod estiż;
English: ● ever had problems with drug abuse - prescribed medicines or illegal drugs - or a problem with alcohol
Maltese: ● qatt kellek problemi b'abbuż mid-droga - ta' mediċini li jingħataw b'riċetta jew ta' drogi illegali - jew problema bl-alkoħol
English: Nasally administered esketamine or placebo; oral AD = a newly initiated AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline)
Maltese: Il-medjan tażżmien għar-rikaduta għal grupp ta' AD mill-ħalq mibdi ġdid (SNRI: duloxetine, venlafaxine jintreħa b'mod estiż;
English: Pre-treatment of healthy subjects with oral ticlopidine, an inhibitor of hepatic CYP2B6 activity, (250 mg twice daily for 9 days prior to and on the day of esketamine administration) had no effect on the Cmax of esketamine administered as a nasal spray.
Maltese: Trattament minn qabel f'individwi f'saħħithom b'ticlopidine mill-ħalq, inibitur tal-attività epatika ta' CYP2B6, (250 mg darbtejn kuljum għal 9 ijiem qabel il-jum u fil-jum tal-għoti ta' esketamine) ma kellu l-ebda effett fuq is-Cmax ta' esketamine mogħti bħala sprej għall-imnieħer.
English: § Number of Study no.
Maltese: Numru ta' pazjenti
English: Revised: {month YYYY}
Maltese: Rata ta' remissjon
English: Adverse Drug Reaction Frequency
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: You should avoid eating for 2 hours before treatment and not drinking liquids for 30 minutes before using this medicine.
Maltese: Inti għandek tevita li tiekol għal sagħtejn qabel it-trattament u ma tixrobx likwidi għal 30 minuta qabel tuża din il-mediċina.
English: Each nasal spray device delivers 28 mg esketamine as two sprays.
Maltese: Kull apparat ta' sprej għall-imnieħer jagħti 28 mg esketamine bħala żewġ sprejs.
English: Majority dosing frequency Weekly
Maltese: Reazzjoni Avversa għall-Mediċina Frekwenza
English: In study TRD3001, a clinically meaningful treatment effect in change in MADRS total scores from baseline at the end of the 4-week induction phase was observed favouring Spravato plus newly initiated oral AD compared with a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Table 5).
Maltese: Fl-istudju TRD3001, ġie osservat effett ta' sinifikat kliniku tat-trattament fil-bidla mill-punteġġi totali MADRS mil-linja bażi fi tmiem il-fażi ta' induzzjoni ta' 4 ġimgħat favur Spravato flimkien mal-AD mibdi ġdid mill-ħalq meta mqabbel mal-AD mibdi ġdid mill-ħalq (SNRI: duloxetine, venlafaxine li jintreħa b'mod estiż;
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 was 273 days, whereas the median was not estimable for Spravato plus oral AD, as this group never reached 50% relapse rate.
Maltese: SSRI: escitalopram, sertraline) flimkien mal-isprej plaċebo għall-imnieħer kien 273 jum, filwaqt li l-medjan ma setax jiġi stmat għal Spravato flimkien ma' AD mill-ħalq, minħabba li dan ilgrupp qatt ma laħaq ir-rata ta' rikaduta ta' 50%.
English: Spravato 84 mg + oral AD
Maltese: 84 mg + AD millħalq
English: Mean plasma esketamine Cmax and AUC∞ values produced by a single, 56-mg dose of esketamine were approximately 14% and 33% higher, respectively, in Chinese subjects compared to Caucasians.
Maltese: Il-medja tal-valuri tas-Cmax u tal-AUC∞ ta' esketamine fil-plażma miksuba minn doża waħda ta' 56 mg ta' esketamine kienu madwar 14% u 33% ogħla, rispettivament, f'individwi Ċiniżi mqabbla ma' Kawkasi.
English: In Study TRD3001, the treatment effect for the Spravato 84 mg plus oral AD group compared with oral AD plus placebo was not statistically significant.
Maltese: Fl-Istudju TRD3001, l-effett tat-trattament għall-grupp ta' Spravato 84 mg flimkien ma' AD mibdi ġdid mill-ħalq imqabbel ma' AD mibdi ġdid mill-ħalq flimkien ma' plaċebo ma kienx sinifikanti b'mod statisitiku.
English: Starting day 1 dose: 56 mg Subsequent doses: 56 mg or 84 mg twice a week
Maltese: 56 mg Dożi sussegwenti: 56 mg jew 84 mg darbtejn filġimgħa
English: However, compared to the recommended dose range, the 112-mg esketamine nasal spray dose was associated with higher rates of adverse reactions, including dizziness, hyperhidrosis, somnolence, hypoaesthesia, feeling abnormal, nausea and vomiting.
Maltese: Madankollu, meta mqabbla mal-firxa tad-doża rrakkomandata, id-doża ta' 112-il mg esketamine ta' sprej għallimnieħer kien assoċjat ma' rati ogħla ta' reazzjonijiet avversi inkluż sturdament, iperidrożi, ħedla tanngħas, ipoestesija, ma tħossokx normali, nawsja u rimettar.
English: Figure 1: Time to relapse in patients in stable remission in study TRD3003 (full analysis set)
Maltese: Figura 1: Żmien għar-rikadutta f'pazjenti f'remssjoni stabbli fl-istudju TRD3003 (sett sħiħ ta' analiżi)
English: 1 green dot
Maltese: TAGĦRIF
English: Patients in TRD3001 and TRD3002 initiated treatment with Spravato 56 mg plus a newly initiated daily oral AD or a newly initiated daily oral AD plus placebo nasal spray on day 1.
Maltese: Pazjenti f'TRD3001 u TRD3002 bdew trattament bi Spravato 56 mg flimkien ma' AD kuljum mill-ħalq mibdi ġdid jew AD mill-ħalq mibdi ġdid flimkien ma' sprej plaċebo għall-imnieħer f'jum 1.
English: ● severe liver problems.
Maltese: problemi fil-bużżieqa tal-awrina.
English: Prepare device
Maltese: Tużax Spravato
English: At the end of 16 weeks of treatment period, patients in stable remission (n=176) or stable response (n=121) were randomised to continue with Spravato or stop Spravato and switch to placebo nasal spray.
Maltese: Fi tmiem is-16-il ġimgħa tal-perjodu tat-trattment, ilpazjenti f'remissjoni stabbli (n=176) jew b'rispons stabbli (n=121) intagħżlu b'mod arbitrarju biex ikomplu Spravato jew iwaqqfu Spravato u jaqilbu għall-isprej plaċebo għall-imnieħer.
English: Pre-treatment of healthy subjects with nasal administration of mometasone furoate (200 mcg per day for 2 weeks with the last mometasone furoate dose administered at 1 hour prior to nasal administration of esketamine) had minor effects on the pharmacokinetics of esketamine.
Maltese: Trattament minn qabel ta' individwi bl-għoti nażali ta' mometasone furoate (200 mcg kuljum għal ġimagħtejn bl-aħħar doża ta' mometasone furoate mogħtija siegħa qabel l-għoti nażali ta' esketamine) kellu effetti minuri fuq il-farmakokinetiċi ta' esketamine.
English: ● Medicines that can increase your blood pressure, such as, thyroid hormones, asthma medications such as xanthine derivatives, medications for child birth bleeding (ergometrine) and heart medication such as vasopressin.
Maltese: ● Mediċini li jistgħu jżidu l-pressjoni tad-demm tiegħek, bħal, ormoni tat-tirojde, mediċini talażma bħal derivati ta' xanthine, mediċini kontra l-ħruġ ta' demm wara l-ħlas (ergometrine) u mediċini tal-qalb bħal vasopressin.
English: Based on the reduction in MADRS total score from baseline, the proportion of patients in Studies TRD3001, TRD3002 and TRD3005 who demonstrated response to Spravato plus oral AD treatment was greater than for oral AD plus placebo nasal spray throughout the 4-week double-blind induction phase (Table 6).
Maltese: Abbażi tat-tnaqqis fil-punteġġ totali ta' MADRS mil-linja bażi, il-proporzjon ta' pazjenti fl-Istudji TRD3001, TRD3002 u TRD3005 li wrew rispons għal Spravato flimkien ma' trattament b'AD mill-ħalq kien akbar minn dak għal AD mill-ħalq flimkien ma' sprej plaċebo għall-imnieħer matul il-fażi kollha ta' induzzjoni ta' 4 ġimgħat fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża (Tabella 6).
English: Nasal spray, solution
Maltese: Sprej għall-imnieħer, soluzzjoni
English: Esketamine is extensively metabolised in the liver.
Maltese: Esketamine huma metabolizzat b'mod estensiv fil-fwied.
English: Biotransformation
Maltese: SPRAVATO +
English: After depressive symptoms improve, treatment is recommended for at least 6 months.
Maltese: Wara li s-sintomi dipressivi imorru għall-aħjar, it-trattament huwa rrakkomandat għal mill-inqas 6 xhur.
English: Exposure numbers were influenced by the study stopping at a pre-determined number of relapses based on the interim analysis.
Maltese: In-numri ta' esponiment kienu influwenzati bl-istudju li waqaf f'numru ta' rikaduti speċifikati minn qabel abbażi tal-analiżi interim.
English: ● Close opposite nostril.
Maltese: ● Tagħfasx il-planġer.
English: In patients whose blood pressure prior to dose administration is judged to be elevated (as a general guide: >140/90 mmHg for patients <65 years of age and >150/90 mmHg for patients ≥65 years of age), it is appropriate to adjust lifestyle and/or pharmacologic therapies to reduce blood pressure before starting treatment with Spravato.
Maltese: >140/90 mmHg għal pazjenti b'età <65 sena u >150/90 mmHg għal pazjenti b'età ≥65 sena), huwa xieraq li tibdel l-istil ta' ħajja/terapiji farmakoloġiċi biex tnaqqas il-pressjoni taddemm qabel tibda t-trattament bi Spravato.
English: If expired, get a new device.
Maltese: Jekk ikun skadut, ġib apparat ieħor.
English: The degree to which esketamine is bound to plasma proteins is not dependent on hepatic or renal function.
Maltese: Il-grad li bih esketamine jintrabat mal-proteini tal-plażma mhuwiex dipendenti fuq il-funzjoni tal-fwied jew tal-kliewi.
English: In clinical studies with esketamine, there were no cases of interstitial cystitis, however a higher rate of lower urinary tract symptoms was observed (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis) in esketamine-treated patients compared with placebo-treated patients.
Maltese: Fi studji kliniċi b'esketamine, ma kien hemm l-ebda każijiet ta' ċistite tal-interstizju, madankollu kienet osservata rata ogħla ta' sintomi fl-apparat tan-naħa ta' isfel tal-awrina (pollakiurja, disurja, urġenza biex tagħmel l-awrina, nokturja, u ċistite) f'pazjenti ttrattati b'esketamine mqabbla malpazjenti ttrattati bil-plaċebo.
English: However, intravenously-administered esketamine was devoid of genotoxic properties in an in vivo bone marrow micronucleus test in rats and an in vivo Comet assay in rat liver cells.
Maltese: Madankollu, esketamine mogħti minn ġol-vini ma kellux proprjetajiet tossiċi fuq il-ġeni f'test tal-mikronukleju tal-mudullun tal-għadam fil-firien in vivo u assaġġ Comet fiċ-ċelluli tal-fwied tal-far in vivo.
English: Urinary tract and bladder symptoms have been reported with Spravato use (see section 4.8).
Maltese: Sintomi tal-passaġġ awrinarju u tal-bużżieqa ġew rapportati bl-użu ta' Sprvato (ara sezzjoni 4.8).
English: feeling light-headed or fainting
Maltese: Sintmomi fl-apparat tal-awrina
English: Instructions for Use SPRAVATO (esketamine) Nasal Spray Device
Maltese: Effett ta' esketamine fuq prodott mediċinali oħra
English: First dose was Spravato 56 mg + oral AD
Maltese: L-ewwel doża kienet Spravato 56 mg + AD mill-ħalq
English: ● Hyperthyroidism that has not been sufficiently treated;
Maltese: ● Ipertirojdiżmu li ma ġiex ittrattat b'mod suffiċjenti;
English: Patients who were responders (455), continued receiving treatment with Spravato plus oral AD in a 12-week optimisation phase.
Maltese: Il-pazjenti li rrispondew għat-trattament (455), komplew jirċievu trattament bi Spravato flimkien ma' AD mill-ħalq f'fażi ta' ottimizzazzjoni ta' 12-il ġimgħa.
English: Adverse reactions reported with esketamine are listed in the table below.
Maltese: Reazzjonijiet avversi rrappuratati b'esketamine huma elenkati fit-tabella taħt.
English: ● a heart problem which is not well controlled such as: poor blood flow in the blood vessels of the heart frequently with chest pain (such as angina), high blood pressure, heart valve disease or heart failure
Maltese: ● qatt kellek problemi fil-pulmun ikkawżati minn diffikultà biex tieħu n-nifs (insuffiċjenza tal pulmuni), li jinkludu Mard Kroniku Pulmonarju Ostruttiv
English: In this study, 31.6% of patients received Spravato for greater than 6 months and 7.9% of patients received Spravato for greater than 1 year in the maintenance phase.
Maltese: F'dan l-istudju, 31.6% tal-pazjenti rċivew Spravato għal aktar minn 6 xhur u 7.9% tal-pazjenti rċivew Spravato għal aktar minn sena fil-fażi ta' manteniment.
English: 3 or more Newly initiated oral antidepressant medication initiated at randomisation, n (%) SNRI SSRI Withdrawn from study (for any reason), n/N (%)
Maltese: 3 jew aktar Antidepressant mill-ħalq mibdi ġdid meta saret l-għażla arbitrarja, n (%) SNRI SSRI
English: Gastrointestinal disorders nausea, vomiting dry mouth, hypoaesthesia oral salivary hypersecretion
Maltese: Jekk inti tieqaf tuża Spravato Huwa importanti li inti tmur għall-appuntamenti skedati, sabiex din il-mediċina tkun effettiva.