FrancophonIA/ELRC3.0 huggingface dataset:
English: The largest time-matched difference versus placebo was 4.62 ms (90% CI 0.40, 8.85 ms), the largest time-matched decrease was -2.71 ms (90% CI -6.97, 1.54 ms), indicating that Xoterna Breezhaler had no relevant impact on the QT interval, as was expected by the properties of its components.
Maltese: L-akbar differenza fil-ħin mqabbel malplaċebo kien ta' 4.62 ms (90% CO 0.40, 8.85 ms), l-akbar tnaqqis fil-ħin imqabbel kien ta' -2.71 ms (90% CI -6.97, 1.54 ms), li juri li Xoterna Breezhaler ma kellu l-ebda impatt relevanti fuq l-intervall tal-QT, kif kien mistenni minħabba l-proprjetajiet tal-komponenti tiegħu.
English: Xoterna Breezhaler prolonged time to first moderate or severe exacerbation with a 22% reduction in risk of an exacerbation (p<0.001) and prolonged time to first severe exacerbation with a 19% reduction in risk of an exacerbation (p=0.046).
Maltese: Xoterna Breezhaler tawwal il-ħin sal-ewwel taħrix moderat jew sever bi tnaqqis ta' 22% fir-riskju ta' taħrix (p<0.001) u tawwal il-ħin sal-ewwel taħrix sever bi tnaqqis ta' 19% fir-riskju ta' taħrix (p=0.046).
English: Xoterna Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Xoterna Breezhaler belong (see section 4.5).
Maltese: Xoterna Breezhaler m'għandux jingħata flimkien ma' prodotti mediċinali li fihom agonisti betaadrenerġiċi oħrajn b'azzjoni fit-tul jew antagonisti muskariniċi b'azzjoni fit-tul, il-gruppi farmakoterapewtiċi li jagħmlu parti minnhom il-komponenti ta' Xoterna Breezhaler (ara sezzjoni 4.5).
English: Xoterna Breezhaler also statistically significantly reduced the annualised rate of all COPD exacerbations (mild, moderate or severe) by 15% as compared to glycopyrronium (p=0.001) and 14% as compared to tiotropium (p=0.002).
Maltese: Xoterna Breezhaler naqqas ukoll b'mod statistikament sinifikanti ir-rata anwalizzata ta' kull taħrix ta' COPD (ħafif, moderat jew sever) b'15% meta mqabbel ma' glycopyrronium (p=0.001) u b'14% meta mqabbel ma' tiotropium (p=0.002).
English: Compared to fluticasone/salmeterol, Xoterna Breezhaler reduced the annualised rate of both moderate or severe exacerbations by 17% (p<0.001), and of severe exacerbations (requiring hospitalisation) by 13% (not statistically significant, p=0.231).
Maltese: Meta mqabbel ma' fluticasone/salmeterol, Xoterna Breezhaler naqqas ir-rata anwalizzata kemm tattaħrix moderat kif ukoll dak sever bi 17% (p<0.001), u ta' taħrix sever (li jeħtieġ rikoveru l-isptar) bi 13% (mhux statistikament sinifikanti, p=0.231).
English: • Do not use the Xoterna Breezhaler inhaler to take any other capsule medicine.
Maltese: • Tużax l-inhaler Xoterna Breezhaler biex tieħu xi kapsula b'mediċina oħra.
English: OUTER CARTON OF UNIT PACK
Maltese: IL-KARTUNA TA' BARRA TAL-PAKKETTI
English: The mean pre-dose FEV1 (average of the values taken at -45 and -15 minutes prior to the morning dose of study medication) was statistically significant in favour of Xoterna Breezhaler at week 26 compared to fluticasone/salmeterol (least squares [LS] mean treatment difference 100 ml, p<0.001), at week 52 compared to placebo (LS mean treatment difference 189 ml, p<0.001) and at all visits up to week 64 compared to glycopyrronium (LS mean treatment difference 70-80 ml, p<0.001) and tiotropium (LS mean treatment difference 60-80 ml, p<0.001).
Maltese: Il-medja tal-FEV1 wara l-għoti tad-doża (il-medja tal-valuri ttieħdet -45 u -15-il minuta qabel ma ngħatat id-doża tal-mediċina mogħtija waqt l-istudju għal filgħodu) kienet sinjifikanti statistikament favur Xoterna Breezhaler fis-26 ġimgħa mqabbel ma' fluticasone/salmeterol (differenza fil-medja talkura tal-anqas kwadri [LS] 100 ml, p<0.001), fit-52 ġimgħa mqabbel ma' plaċebo (differenza filmedja tal-kura ta' LS ta' 189 ml, p<0.001) u waqt il-viżti kollha sal-64 ġimgħa mqabbel ma' glycopyrronium (differenza fil-medja tal-kura ta' LS ta' 70-80 ml, p <0.
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Xoterna Breezhaler contains lactose”).
Maltese: - Is-sustanzi l-oħra tat-trab li jittieħed man-nifs huma l-lactose monohydrate u magnesium stearate (ara sezzjoni 2 taħt “Xoterna Breezhaler fih il-lactose”).
English: The presentation of the safety profile is based on the experience with Xoterna Breezhaler and the individual active substances.
Maltese: Il-preżentazzjoni tal-profil ta' sigurtà tissejjes fuq l-esperjenza ta' Xoterna Breezhaler u s-sustanzi attivi individwali.
English: Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder.
Maltese: Xoterna Breezhaler 85 mikrogramma/43 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa trasparenti u sofor u fihom trab minn abjad għal kważi abjad.
English: In a another study comparing Xoterna Breezhaler (n=258) and fluticasone/salmeterol (n=264), for 26 weeks, the number of moderate or severe COPD exacerbations/patient-years was 0.15 versus 0.18 (18 events versus 22 events), respectively (p=0.512), and the number of all COPD exacerbations/patient-years (mild, moderate or severe) was 0.72 versus 0.94 (86 events versus 113 events), respectively (p=0.098).
Maltese: Fi studju ieħor li qabbel Xoterna Breezhaler (n=258) u fluticasone/salmeterol (n=264) għal 26 ġimgħa, l-għadd ta' taħrixiet ta' COPD ħfief jew moderat/snin ta' pazjent kien ta' 0.15 kontra 0.18 (18il avveniment kontra 22 avveniment), rispettivament (p=0.512), u n-numru ta' kull taħrix tasCOPD/snin ta' pazjent (ħafif, moderat jew sever) kien ta' 0.
English: A statistically significantly higher percentage of patients receiving Xoterna Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (68.1% and 57.5% respectively, p=0.004).
Maltese: Persentaġġ ogħla u sinjifikanti statistikament ta' pazjenti mogħtija Xoterna Breezhaler irrispondew b'titjib ta' punt 1 jew akbar fl-iskor fokali tat-TDI fis-26 ġimgħa mqabbel mal-plaċebo (68.1% u 57.5% rispettivament, p=0.004).
English: Time to first pneumonia was prolonged with Xoterna Breezhaler compared to fluticasone/salmeterol (p=0.013).
Maltese: Il-ħin sal-ewwel avveniment ta' pnewmonja ttawwal b'Xoterna Breezhaler meta mqabbel ma' fluticasone/salmeterol (p=0.013).
English: The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on day 14 or day 15 compared to day 1, was in the range of 2.9 to 3.8 for once-daily inhaled doses between 60 micrograms and 480 micrograms (delivered dose).
Maltese: Il-proporzjon medju tal-akkumulazzjoni ta' indacaterol, jiġifieri l-AUC wara intervall fl-għoti tad-doża ta' 24 siegħa fl-14-jew il-15-il ġurnata meta mqabbel mal-ewwel ġurnata, kien ta' bejn 2.9 u 3.8 għal dożi ta' bejn 150 mikrogramma u ta' 600 mikrogramma and 480 mikrogramma (doża meħuda).
English: No specific interaction studies were conducted with Xoterna Breezhaler.
Maltese: Ma sarux studji speċifiċi interattivi b'Xoterna Breezhaler.
English: The effects of Xoterna Breezhaler on QTc interval were investigated in healthy volunteers after inhalation of Xoterna Breezhaler up to 4 times the recommended therapeutic dose in four dose steps each separated by one hour.
Maltese: L-effetti ta' Xoterna Breezhaler fuq l-intervall tal-QTc kien mistħarreġ fost voluntiera b'saħħithom wara li ħadu man-nifs Xoterna Breezhaler sa 4 darbiet aktar id-doża terapewtika rrakkomandata mqassma f'4 stadji kull wieħed imbiegħed mill-ieħor b'siegħa.
English: Based on the clinical pharmacokinetic characteristics of its monotherapy components, Xoterna Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Maltese: Skont karatteristiċi farmakokinetiċi kliniċi tal-komponenti monoterapewtiċi tiegħu, Xoterna Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-fwied minn ħafif sa moderat.
English: EXP
Maltese: Tapp
English: In the 52-week active-controlled study, the mean pre-dose FEV1 was statistically significant in favour of Xoterna Breezhaler at all visits up to week 52 compared to fluticasone/salmeterol (LS mean treatment difference 62-86 ml, p<0.001).
Maltese: Fl-istudju ta' 52 ġimgħa kkontrollat bl-attiv, il-medja tal-FEV1 ta' qabel id-doża kienet statistikament sinifikanti favur Xoterna Breezhaler waqt il-viżti kollha sat-52 ġimgħa, meta mqabbel ma' fluticasone/salmeterol (differenza fil-medja tal-kura ta' LS ta' 62-86 ml, p<0.001).
English: Based on the in vitro performance data, the dose of indacaterol delivered to the lung is expected to be similar for Xoterna Breezhaler and indacaterol monotherapy product.
Maltese: Skont id-dejta ta' wirja in vitro, id-doża ta' indacaterol imwassla fil-pulmun hi mistennija li tkun tixbah lil dik ta' Xoterna Breezhaler u l-prodott monoterapewtiku b'indacaterol.
English: Xoterna Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Maltese: Xoterna Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti anzjani (minn 75 sena 'l fuq).
English: Show the pack of Xoterna Breezhaler.
Maltese: Uri l-pakkett ta' Xoterna Breezhaler.
English: Heart rate effects in healthy volunteers were investigated after a single dose of 4 times the recommended therapeutic dose of Xoterna Breezhaler administered in four dose steps each separated by one hour and compared to the effects of placebo, indacaterol, glycopyrronium and salmeterol.
Maltese: L-effetti fuq ir-rata tal-qalb f'voluntiera b'saħħithom kienu investigati wara doża singola ta' 4 darbiet id-doża terapewtika rrakkomandata ta' Xoterna Breezhaler mogħti f'doża mqassma f'4 stadji kull wieħed imbiegħed mill-ieħor b'siegħa u mqabbel mal-effetti tal-plaċebo, indacaterol, glycopyrronium u salmeterol.
English: Xoterna Breezhaler is used as an ongoing treatment for your COPD.
Maltese: Xoterna Breezhaler jintuża bħala trattament kontinwu għas-COPD.
English: In healthy volunteers, after the administration of 4 times the recommended therapeutic dose of Xoterna Breezhaler, the effect on serum potassium was very small (maximal difference -0.14 mmol/l when compared to placebo).
Maltese: L-effett fuq il-potassju fis-serum fost voluntiera b'saħħithom, wara l-għoti ta' 4 darbiet aktar mid-doża terapewtika rrakkomandata ta' Xoterna Breezhaler, kien żgħir ħafna (id-differenza massima ta'0.14 mmol/l meta mqabbel mal-plaċebo).
English: A population pharmacokinetic analysis of data in COPD patients after inhalation of Xoterna Breezhaler indicated no significant effect of age, gender and (lean body) weight on the systemic exposure to indacaterol and glycopyrronium.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tad-dejta fost pazjenti b'COPD wara li ħadu Xoterna Breezhaler man-nifs uriet li ma hemmx effett sinjifikanti tal-età, is-sess u (ġisem immejjel) l-piż fuq lespożizzjoni sistemika ta' indicaterol u glycopyrronium.
English: During long-term clinical studies, more patients on Xoterna Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
Maltese: Waqt studji kliniċi fit-tul, aktar pazjenti mogħtija Xoterna Breezhaler kellhom tibdil notevoli klinikament fil-livell tal-glukosju (4.9%) fid-demm skont id-doża rrakkomandata milli meta ngħata lplaċebo (2.7%).
English: The co-administration of Xoterna Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' Xoterna Breezhaler ma' prodotti mediċinali oħrajn li fihom antikolinerġiċi ma ġiex studjat u għalhekk mhuwiex irrakkomandat (ara sezzjoni 4.4).
English: Serum potassium and blood glucose
Maltese: Il-potassju fis-serum u l-glukosju fid-demm
English: Xoterna Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Maltese: Xoterna Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-kliewi bejn ħafif u moderat.
English: 5 ml (2.4 mg/ml) 1 vial
Maltese: 5 ml (2.4 mg/ml) 1 kunjett
English: 12 mg Solution for injection
Maltese: 12 mg Soluzzjoni għallinjezzjoni
English: Intrathecal use Vial (glass)
Maltese: Isem (Ivvintat)
English: LS mean difference (95% CI)†
Maltese: Differenza medja ta' LS (95% CI)†
English: AD = antidepressant; NA = not available
Maltese: AD = antidepressant; NA = mhux disponibbli
English: Weeks 5-8:
Maltese: Ġimgħat 5-8:
English: Race, n (%)
Maltese: Razza, n (%)
English: Weeks 1-4:
Maltese: Ġimgħat 1-4:
English: Age, years
Maltese: Età, snin
English: Sex, n (%)
Maltese: Sess, n (%)
English: From week 9:
Maltese: Minn ġimgħa 9:
English: ● Sleep apnoea with morbid obesity (BMI ≥35);
Maltese: ● Apnea tal-irqad b'obeżità morbida (BMI ≥35);
English: Other CYP enzymes, including CYP2C19 and CYP2C9, contribute to a much smaller extent.
Maltese: Enzimi CYP oħra, inklużi CYP2C19 u CYP2C9, jikkontribwixxu fi grad ħafna inqas.
English: Median (Range)
Maltese: Medjan (Firxa)
English: • Risk factors/groups/ signs of abuse and dependence, which should be regularly assessed and monitored;
Maltese: • Fatturi ta' riskju/gruppi/sinjali ta' abbuż u dipendenza, li għandhom jiġu assessjati regolarment u monitorati;
English: ● panic attacks
Maltese: ● attakki ta' paniku
English: 56 mg = 2 devices
Maltese: 56 mg = 2 apparati
English: 84 mg = 3 devices
Maltese: 84 mg = 3 apparati
English: Excipients: Citric acid monohydrate, disodium edetate, sodium hydroxide, water for injections.
Maltese: Eċċipjenti: Citric acid monohydrate, disodium edetate, sodium hydroxide, ilma għall-injezzjonijiet.
English: Overall a total of 705 patients were enrolled; 437 directly enrolled; 150 transferred from TRD3001, and 118 transferred from TRD3002.
Maltese: Globalment ġew irreġistrati total ta' 705 pazjenti; 437 ġew irreġistrati b'mod dirett; 150 ġew trasferiti minn TRD3001, u 118 ġew trasferiti minn TRD3002.
English: The main cytochrome P450 (CYP) enzymes responsible for esketamine N-demethylation are CYP2B6 and CYP3A4.
Maltese: Lenzimi prinċipali taċ-ċitokrom P450 (CYP) responsabbli għal N-demethylation ta' esketamine huma CYP2B6 u CYP3A4.
English: 1,833 adult patients were enrolled, of which 1,601 patients were exposed to Spravato.
Maltese: Ġew irreġistrati 1,833 pazjent adult, li minnhom 1,601 pazjent ġew esposti għal Spravato.
English: Elderly (>65 years)
Maltese: Anzjani (> 65 sena)
English: The most commonly observed adverse reactions in treatment-resistant depression patients treated with Spravato were dizziness (30%), nausea (27%), dissociation (26%), headache (24%), somnolence (18%), vertigo (18%), dysgeusia (17%), hypoaesthesia (11%), and vomiting (10%).
Maltese: L-aktar reazzjonijiet avversi komuni osservati f'pazjenti b'depressjoni reżistenti għat-trattament ittrattati bi Spravato kienu sturdament (30%), nawsja (27%), dissoċjazzjoni (26%), uġigħ ta' ras (24%), ħedla (18%), vertigo (18%), disgewżja (17%), ipoestesija (11%), u rimettar (10%).
English: Esketamine is the S-enantiomer of racemic ketamine.
Maltese: Esketamine huwa l-enantjomer S ta' ketamine raċemiku.
English: Studies TRANSFORM-1 (TRD3001) and TRANSFORM-2 (TRD3002) were conducted in adults (18 to < 65 years) and Study TRANSFORM-3 (TRD3005) was conducted in adults ≥ 65 years of age.
Maltese: L-istudji TRANSFORM-1 (TRD3001) u TRANSFORM-2 (TRD3002) saru fl-adulti (18 sa < 65 sena) u l-Istudju TRANSFORM-3 (TRD3005) sar f'adulti b'età ≥ 65 sena.
English: Esketamine does not inhibit these transporters or multi-drug and toxin extrusion 1 (MATE1) and MATE2-K, or organic cation transporter 2 (OCT2), OAT1, or OAT3.
Maltese: Esketamine ma jinibixxix dawn it-trasportaturi jew il-proteina li tippompja 'l barra ħafna mediċini u tossini 1 (MATE1, multi-drug and toxin extrusion 1) u MATE2-K, jew it-trasportatur katjonu organiku 2 (OCT2), OAT1, jew OAT3.
English: Study TRD3005 (N=137)
Maltese: Studji TRD3005 (N=137)
English: Study TRD3001 (N=342)
Maltese: Studji TRD3001 (N=342)
English: The incidence of increased SBP (≥ 180 mmHg) was 3% and DBP (≥ 110 mmHg) was
Maltese: L-inċidenza ta' żieda fl-SBP (≥ 180 mmHg) kienet 3% u fid-DBP (≥ 110 mmHg) kienet 4%.
English: Esketamine is not a substrate of transporters P-glycoprotein (P-gp; multidrug resistance protein 1), breast cancer resistance protein (BCRP), or organic anion transporter (OATP) 1B1, or OATP1B3.
Maltese: Esketamine mhuwiex sustrat għat-trasportaturi tal-glikoproteina P (P-gp, P-glycoprotein; proteina ta' reżistenza għall-ħafna mediċini 1), għall-proteina ta' reżistenza tal-kanċer tas-sider (BCRP, breast cancer resistance protein), jew trasportaturi anjoniċi organiċi (OATP, organic anion transporter) 1B1, jew OATP1B3.
English: 28 mg = 1 device
Maltese: 28 mg = apparat 1
English: Within the designated system organ classes, adverse reactions are listed under headings of frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Fil-klassijiet tas-sistemi u tal-organi ddefiniti, ir-reazzjonijiet avversi huma elenkati taħt it-titli ta' frekwenza, bl-użu talkonvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Relative to the subjects with normal renal function (creatinine clearance [CLCR], 88 to 140 mL/min), the Cmax of esketamine was on average 20 to 26% higher in subjects with mild (CLCR, 58 to 77 mL/min), moderate (CLCR, 30 to 47 mL/min), or severe (CLCR, 5 to 28 mL/min, not on dialysis) renal impairment following administration of a 28-mg dose of esketamine nasal spray.
Maltese: Meta mqabbla ma' individwi b'funzjoni normali tal-kliewi (tneħħija tal-kreatinina [CLCR], 88 sa 140 mL/min), is-Cmax ta' esketamine kienet bejn wieħed u ieħor 20 sa 26% ogħla f'individwi b'indeboliment ħafif (CLCR, 58 sa 77 mL/min), moderat (CLCR, 30 sa 47 mL/min), jew sever (CLCR, 5 sa 28 mL/min, mhux fuq id-dijalisi) tal-kliewi wara għoti ta' doża ta' 28 mg ta' sprej għall-imnieħer esketamine.
English: Remission was defined as a MADRS total score ≤ 12.
Maltese: Remissjoni ġiet iddefinita bħala punteġġ totali MADRS ≤ 12.
English: Pack sizes of 1, 2, 3, or 6 nasal spray devices.
Maltese: Daqsijiet tal-pakkett ta' apparat 1, 2, 3, jew 6 apparati tal-isprej għall-imnieħer.
English: EU/1/19/1410/001 (1 spray container) EU/1/19/1410/002 (2 spray containers) EU/1/19/1410/003 (3 spray containers) EU/1/19/1410/004 (6 spray containers)
Maltese: EU/1/19/1410/001 (kontenitur tal-isprej 1) EU/1/19/1410/002 (2 kontenituri tal-isprej) EU/1/19/1410/003 (3 kontenituri tal-isprej) EU/1/19/1410/004 (6 kontenituri tal-isprej)
English: Effect of other medicinal products on esketamine
Maltese: Effett ta' prodotti mediċnali oħra fuq esketamine
English: On average, esketamine Cmax was 10% lower and AUC∞ was 17% higher in Korean subjects, relative to Caucasian subjects.
Maltese: Bħala medja, is-Cmax ta' esketamine kienet 10% aktar baxxa u l-AUC∞ kienet 17% ogħla f'individwi Koreani, meta mqabbla ma' individwi Kawkasi.
English: Spravato + Oral AD (N=90)
Maltese: Spravato + AD mill-ħalq (N=90)
English: EU/1/19/1410/002 (2 spray containers) EU/1/19/1410/003 (3 spray containers)
Maltese: EU/1/19/1410/002 (2 kontenituri tal-isprej) EU/1/19/1410/003 (3 kontenituri tal-isprej)
English: ● persistent ringing in the ears (tinnitus)
Maltese: ● tisfir persistenti fil-widnejn (tinnitus)
English: The Cmax and AUC∞ of esketamine were 8% higher and 103% higher, respectively, in subjects with Child-Pugh class B (moderate) hepatic impairment, relative to healthy subjects.
Maltese: Is-Cmax u l-AUC∞ ta' esketamine kienu 8% ogħla u 103% ogħla, rispettivament, f'individwi b'indeboliment tal-fwied talklassi B ta' Child-Pugh (moderat), meta mqabla ma' individwi f'saħħithom.
English: EU/1/19/1410/001 (1 spray container) EU/1/19/1410/004 (6 spray containers)
Maltese: EU/1/19/1410/001 (kontenitur tal-isprej 1) EU/1/19/1410/004 (6 kontenituri tal-isprej)
English: ● Significant pulmonary insufficiency, including COPD;
Maltese: ● Insuffiċjenza pulmonari sinjifikanti, li jinkludi COPD;
English: 56 mg pack = 2 nasal spray devices 84 mg pack = 3 nasal spray devices
Maltese: Pakkett ta' 56 mg = 2 apparati ta' sprej għall-imnieħer Pakkett ta' 84 mg = 3 apparati ta' sprej għall-imnieħer
English: Dependence and tolerance have been reported with prolonged use of ketamine.
Maltese: Dipendenza u tolleranza ġew irrappurtati bl-użu fit-tul ta' ketamine.
English: Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants, ATC code: N06AX27.
Maltese: Psikoanalettiċi; Antidepressanti oħra, Kodiċi ATC:
English: Ear and labyrinth disorders vertigo hyperacusis, tinnitus
Maltese: Disturbi fil-widnejn u fissitema labirintika vertigo iperakusi, tinnitus
English: Esketamine exposure increases with dose from 28 mg to 84 mg.
Maltese: L-esponmient għal esketamine jiżdied ma' żieda fid-doża minn 28 mg sa 84 mg.
English: ● Medicines for depression or Parkinson's disease known as monoamine oxidase inhibitors (MAOIs) (for example, tranylcypromine, selegiline, phenelzine).
Maltese: ● Mediċini għal depressjoni jew għall-marda ta' Parkinson magħrufa bħala inibituri ta' monoamine oxidase (MAOIs, monoamine oxidase inhibitors) (per eżempju, tranylcypromine, selegiline, phenelzine).
English: Blood pressure should be closely monitored when Spravato is used concomitantly with psychostimulants (e.g., amphetamines, methylphenidate, modafanil, armodafinil) or other medicinal products that may increase blood pressure (e.g. xanthine derivatives, ergometrine, thyroid hormones, vasopressin, or MAOIs, such as, tranylcypromine, selegiline, phenelzine).
Maltese: Il-pressjoni tad-demm għandha tiġi mmonitorjata mill-qrib meta Spravato jintuża flimkien ma' psikostimulanti (eż., amfetamini, methylphenidate, modafanil, armodafinil) jew prodotti mediċinali oħrajn li jistgħu jżidu l-pressjoni tad-demm (eż. derivati ta' xanthine, ergometrine, ormoni tat-tirojde, vasopressin, jew MAOIs, bħal, tranylcypromine, selegiline, phenelzine).
English: In clinical trials, increases in systolic and diastolic blood pressure (SBP and DBP) over time were about 7 to 9 mmHg in SBP and 4 to 6 mmHg in DBP at 40 minutes post-dose and 2 to 5 mmHg in SBP and 1 to 3 mmHg in DBP at 1.5 hours post-dose in patients receiving Spravato plus oral antidepressants (see section 4.4).
Maltese: Fil-provi kliniċi, żidiet fil-pressjoni sistolika u dijastolika tad-demm (SBP u DBP) mal-ħin kienu madwar 7 sa 9 mmHg fl-SBP u 4 sa 6 mmHg fid-DBP 40 minuta wara d-doża u 2 sa 5 mmHg fl-SBP u 1 sa 3 mmHg fid-DBP 1.5 siegħa wara d-doża f'pazjenti li kienu qed jirċievu Spravato flimkien ma' antidepressanti mill-ħalq (ara sezzjoni 4.4).
English: It is a non-selective, non-competitive, antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.
Maltese: Huwa antagonist mhux selettiv, mhux kompetittiv tar-riċettur N-methyl-D-aspartate (NMDA), riċettur ionotropiku tal-glutamate.
English: ● Hypersensitivity to the active substance, ketamine, or to any of the excipients listed in section 6.1
Maltese: ● Sensittività eċċessiva għas-sustanza attiva, ketamine, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Spravato + Oral AD (N=62)
Maltese: Spravato + AD mill-ħalq (N=62)
English: 2 green dots (0 mg delivered)
Maltese: 2 tikek ħodor (ingħataw 0 mg)
English: The maintenance of antidepressant efficacy was demonstrated in a relapse prevention trial.
Maltese: Il-manteniment tal-effikaċja tal-antidepressant intweriet fi prova ta' prevenzjoni ta' rikaduta.
English: Spravato 28 mg nasal spray, solution esketamine
Maltese: Spravato 28 mg sprej għall-imnieħer, soluzzjoni esketamine
English: Table 1: Recommended dosing for Spravato in adults <65 years Induction phase
Maltese: Tabella 1: Għoti tad-doża rrakkomandata għal Spravato f'adulti <65 sena Fażi ta' induzzjoni