FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Adverse reaction observed with Xoterna Breezhaler, but not with the individual components.
Danish: Ikke almindelig Bivirkning observeret for Xoterna Breezhaler, men ikke for de individuelle komponenter.
English: Palpitations
Danish: Palpitatioer
English: Xoterna Breezhaler demonstrated a statistically superior improvement versus tiotropium in the percentage of “days able to perform usual daily activities” over 26 weeks (LS mean treatment difference 8.45%, p<0.001).
Danish: Xoterna Breezhaler viste en signifikant overlegen forbedring versus tiotropium i andel af ”dage med evne til at udføre daglige aktiviteter” i løbet af 26 uger (LS gennemsnitlig behandlingsforskel 8,45 %, p<0,001).
English: In COPD patients, supratherapeutic doses between 116 micrograms/86 micrograms and 464 micrograms/86 micrograms of Xoterna Breezhaler showed a higher proportion of patients with QTcF increases vs. baseline between 30 ms and 60 ms (ranging from 16.0% to 21.6% vs. 1.9% for placebo), but there were no QTcF increases >60 ms from baseline.
Danish: Hos KOL-patienter medførte supraterapeutiske doser af Xoterna Breezhaler på mellem 116 mikrogram/86 mikrogram og 464 mikrogram/86 mikrogram en højere andel af patienter med QTcF-stigning versus baseline på mellem 30 ms og 60 ms (rangerende fra 16,0 % til 21,6 % versus 1,9 % for placebo), men der var ingen QTcF-stigninger >60 ms i forhold til baseline.
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).
Danish: I et andet studie, der sammenligner Xoterna Breezhaler (n=258) og fluticason/salmeterol (n=264) i 26 uger, var antallet af moderate til svære KOL-eksacerbationer/patient-år henholdsvis 0,15 versus 0,18 (18 tilfælde versus 22 tilfælde) (p=0,512), og antallet af alle KOL-eksacerbationer/patient-år (milde, moderate og svære) var henholdsvis 0,72 versus 0,94 (86 tilfælde versus 113 tilfælde) (p=0,098).
English: Steady-state exposure to indacaterol after Xoterna Breezhaler inhalation was either similar or slightly lower than systemic exposure after indacaterol monotherapy product inhalation.
Danish: Eksponering ved steady state af indacaterol efter inhalation af Xoterna Breezhaler var enten den samme eller en anelse lavere end systemisk eksponering efter inhalation af indacaterol monoterapiprodukt.
English: After three weeks of treatment, the improvement in inspiratory capacity with Xoterna Breezhaler was greater (LS mean treatment difference 320 ml, p<0.001) and exercise endurance time increased (LS mean treatment difference 59.5 seconds, p=0.006) compared to placebo.
Danish: Efter tre ugers behandling var forbedringen i inspiratorisk kapacitet med Xoterna Breezhaler større (LS gennemsnitlig behandlingsforskel 320 ml, p<0,001) og varigheden af udholdenhed under fysisk aktivitet øget (LS gennemsnitlig behandlingsforskel 59,5 sekunder, p=0,006) sammenlignet med placebo.
English: No data are available in patients with urinary retention, therefore Xoterna Breezhaler should be used with caution in these patients.
Danish: Der foreligger ingen data for patienter med urinretention, Xoterna Breezhaler bør derfor anvendes med forsigtighed hos disse patienter.
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).
Danish: I det 52-ugers aktivkontrolleret studie var den gennemsnitlige før-dosis FEV1 statistisk signifikant til fordel for Xoterna Breezhaler ved alle besøg op til uge 52 sammenlignet med fluticason/salmeterol (LS gennemsnitlig behandlingsforskel 62-86 ml, p<0,001).
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.
Danish: Den største tidsmæssige forskel sammenlignet med placebo var 4,62 ms (90 % CI 0,40, 8,85 ms), og den største tidsmæssige nedsættelse var -2,71 ms (90 % CI -6,97, 1,54 ms), hvilket indikerer at Xoterna Breezhaler ikke har nogen relevant indvirkning på QT-intervallet.
English: The number of all COPD exacerbations/patient-years was 3.34 for Xoterna Breezhaler (2,893 events), 3.92 for glycopyrronium (3,294 events) and 3.89 for tiotropium (3,301 events).
Danish: Antallet af alle KOL-eksacerbationer/patient-år var 3,34 for Xoterna Breezhaler (2.893 tilfælde), 3,92 for glycopyrronium (3.294 tilfælde) og 3,89 for tiotropium (3.301 tilfælde).
English: Steady-state exposure to glycopyrronium after Xoterna Breezhaler inhalation was similar to systemic exposure after glycopyrronium monotherapy product inhalation.
Danish: Steady state eksponering af glycopyrronium efter inhalation af Xoterna Breezhaler var den samme som systemisk eksponering efter inhalation af glycopyrronium monoterapiproduktet.
English: There are no data available for the use of Xoterna Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2).
Danish: Der er ingen tilgængelige data for brug af Xoterna Breezhaler til patienter med stærkt nedsat leverfunktion, der skal derfor iagttages forsigtighed hos disse patienter (se pkt.
English: SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Danish: Eesti SIA Novartis Baltics Eesti filiaalTel: +372 66 30
English: If you forget to use Xoterna Breezhaler
Danish: Hvis du har glemt at tage Xoterna Breezhaler
English: No data are available in patients with narrow-angle glaucoma, therefore Xoterna Breezhaler should be used with caution in these patients.
Danish: Der foreligger ingen data for patienter med snævervinklet glaukom, Xoterna Breezhaler bør derfor anvendes med forsigtighed hos disse patienter.
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).
Danish: Hos raske, frivillige forsøgspersoner var virkningen på serumkalium meget lille efter indgift af en dosis, der var 4 gange højere end den anbefalede terapeutiske dosis af Xoterna Breezhaler (maksimal forskel sammenlignet med placebo var -0,14 mmol/l).
English: Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder.
Danish: Udseende af Xoterna Breezhaler og pakningsstørrelser Xoterna Breezhaler 85 mikrogram/43 mikrogram inhalationspulver, hårde kapsler, er gennemsigtige og gule og indeholder et hvidt til næsten hvidt pulver.
English: The number of moderate or severe COPD exacerbations/patient-years was 0.98 for Xoterna Breezhaler (1,265 events) and 1.19 for fluticasone/salmeterol (1,452 events).
Danish: Antallet af moderate eller svære KOL-eksacerbationer/patientår var 0,98 for Xoterna Breezhaler (1.265 tilfælde) og 1,19 for fluticason/salmeterol (1.452 tilfælde).
English: Xoterna Breezhaler has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at 26 weeks compared to placebo (LS mean treatment difference -3.01, p=0.002) and tiotropium (LS mean treatment difference -2.13, p=0.009) and reductions versus indacaterol and glycopyrronium were -1.09 and -1.18, respectively.
Danish: Xoterna Breezhaler har også vist en statistisk signifikant virkning på helbredsrelateret livskvalitet målt ved hjælp af St. George's Respiratory Questionnaire (SGRQ) udtrykt ved en reduktion i SGRQ totalscore efter 26 uger sammenlignet med placebo (LS gennemsnitlig behandlingsforskel -3,01, p=0,002) og tiotropium (LS gennemsnitlig behandlingsforskel -2,13, p=0,009) og reduktioner sammenlignet med indacaterol og glycopyrronium var henholdsvis -1,09 og -1,18.
English: The number of all COPD exacerbations/patient-years was 3.59 for Xoterna Breezhaler (4,531 events) and 4.03 for fluticasone/salmeterol (4,969 events).
Danish: Antallet af alle KOL-eksacerbationer/patientår var 3,59 for Xoterna Breezhaler (4.531 tilfælde) og 4,03 for fluticason/salmeterol (4.969 tilfælde).
English: A higher proportion of patients demonstrated clinically meaningful response at week 26 on Xoterna Breezhaler as compared to tiotropium (68.1% Xoterna Breezhaler versus 59.2% tiotropium, p=0.016) and fluticasone/salmeterol (65.1% Xoterna Breezhaler versus 55.5% fluticasone/salmeterol, p=0.088).
Danish: En signifikant højere andel af patienterne på Xoterna Breezhaler viste klinisk betydningsfuldt respons ved uge 26 sammenlignet med patienter på tiotropium (68,1 % Xoterna Breezhaler versus 59,2 % tiotropium, p=0,016) og patienter på fluticason/salmeterol (65,1 % Xoterna Breezhaler versus 55,5 % fluticason/salmeterol, p=0,088).
English: Over 26 weeks, Xoterna Breezhaler statistically significantly reduced the use of rescue medication (salbutamol) by 0.96 puffs per day (p<0.001) compared to placebo, 0.54 puffs per day (p<0.001) compared to tiotropium and 0.39 puffs per day (p=0.019) compared to fluticasone/salmeterol.
Danish: Xoterna Breezhaler nedsatte over 26 uger brugen af anfaldsmedicin (salbutamol) statistisk signifikant med 0,96 sug per dag (p<0,001) sammenlignet med placebo, 0,54 sug per dag (p<0,001) sammenlignet med tiotropium og 0,39 sug per dag (p=0,019) sammenlignet med fluticason/salmeterol.
English: A higher percentage of patients receiving Xoterna Breezhaler responded with a clinically meaningful improvement in SGRQ score (defined as a decrease of at least 4 units from baseline) at week 26 compared to placebo (63.7% and 56.6% respectively, p=0.088) and tiotropium (63.7% Xoterna Breezhaler vs. 56.4% tiotropium, p=0.047), at week 64 compared to glycopyrronium and tiotropium (57.3% Xoterna Breezhaler versus 51.8% glycopyrronium, p=0.055; versus 50.8% tiotropium, p=0.051, respectively) and at week 52 compared to fluticasone/salmeterol (49.2% Xoterna Breezhaler vs. 43.7% fluticasone/salmeterol, odds ratio: 1.30, p<0.001).
Danish: En højere procentdel af patienter, som fik Xoterna Breezhaler, responderede med en klinisk betydningsfuld forbedring i SGRQ-score (defineret som et fald på mindst 4 enheder fra udgangsværdien) ved uge 26 sammenlignet med placebo (henholdsvis 63,7 % og 56,6 %, p=0,088) og tiotropium (63,7 % Xoterna Breezhaler versus 56,4 % tiotropium, p=0,047), ved uge 64 sammenlignet med glycopyrronium og tiotropium (henholdsvis 57,3 % Xoterna Breezhaler versus 51,8 % glycopyrronium, p=0,055; versus 50,8 % tiotropium, p=0,051), og ved uge 52 sammenlignet med fluticason/salmeterol (49,2 % Xoterna Breezhaler versus 43,7 % fluticason/salmeterol, odds ratio: 1,30, p<0,001).
English: The number of moderate or severe COPD exacerbations/patient-years was 0.94 for Xoterna Breezhaler (812 events), 1.07 for glycopyrronium (900 events) and 1.06 for tiotropium (898 events).
Danish: Antallet af moderate til svære KOL-eksacerbationer/patientår var 0,94 for Xoterna Breezhaler (812 tilfælde), 1,07 for glycopyrronium (900 tilfælde) og 1,06 for tiotropium (898 tilfælde).
English: • One Xoterna Breezhaler inhaler
Danish: • En Xoterna Breezhaler inhalator
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).
Danish: Den gennemsnitlige før-dosis FEV1 (gennemsnittet af værdierne målt ved -45 og -15 minutter før morgendosis af studiemedicin) var statistisk signifikant til fordel for Xoterna Breezhaler sammenlignet med fluticason/salmeterol (least squares [LS] gennemsnitlig behandlingsforskel 100 ml, p<0,001) ved uge 26, sammenlignet med placebo (LS gennemsnitlig behandlingsforskel 189 ml, p<0,001) efter uge 52 og ved alle besøg op til uge 64 sammenlignet med glycopyrronium (LS gennemsnitlig behandlingsforskel 70-80 ml, p<0,001) og tiotropium (60-80 ml, p<0,001).
English: Overall the effect on heart rate over time did not show a consistent pharmacodynamic effect of Xoterna Breezhaler.
Danish: Generelt sås ingen konsistent farmakodynamisk virkning af Xoterna Breezhaler på hjertefrekvensen over tid.
English: How to inhale Xoterna Breezhaler - Xoterna Breezhaler is for inhalation use.
Danish: Sådan skal du inhalere Xoterna Breezhaler - Xoterna Breezhaler tages ved indånding.
English: What you need to know before you use Xoterna Breezhaler
Danish: Det skal du vide, før du begynder at tage Xoterna Breezhaler
English: COPD is a long-term disease and you should use Xoterna Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Fortsæt med at bruge Xoterna Breezhaler så længe din læge siger du skal gøre det. - KOL er en kronisk sygdom, og du skal tage Xoterna Breezhaler hver dag og ikke blot, når du har åndedrætsbesvær eller andre symptomer på KOL.
English: Xoterna Breezhaler contains lactose
Danish: Xoterna Breezhaler indeholder lactose
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.
Danish: Udfra de kliniske farmakokinetiske karakteristika af dets monoterapikomponenter kan Xoterna Breezhaler anvendes i de anbefalede doser til patienter med mildt til moderat nedsat leverfunktion.
English: Xoterna Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Danish: Xoterna Breezhaler kan bruges i den anbefalede dosis til patienter med mildt til moderat nedsat leverfunktion.
English: Xoterna Breezhaler statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI); it demonstrated a statistically significant improvement in the TDI focal score at week 26 compared to placebo (LS mean treatment difference 1.09, p<0.001), tiotropium (LS mean treatment difference 0.51, p=0.007) and fluticasone/salmeterol (LS mean treatment difference 0.76, p=0.003).
Danish: Xoterna Breezhaler medførte statistisk signifikant reduktion af åndenød evalueret ved hjælp af Transitional Dyspnoea Index (TDI); og viste en statistisk signifikant forøgelse i TDI fokal score ved uge 26 sammenlignet med placebo (LS gennemsnitlig behandlingsforskel 1,09, p<0,001), tiotropium (LS gennemsnitlig behandlingsforskel 0,51, p=0,007) og fluticason/salmeterol (LS gennemsnitlig behandlingsforskel 0,76, p=0,003).
English: Xoterna Breezhaler increased post-dose trough FEV1 by 200 ml compared to placebo at the 26-week primary endpoint (p<0.001) and showed statistically significant increases compared to each monotherapy component treatment arm (indacaterol and glycopyrronium) as well as the tiotropium treatment arm, as shown in the below table.
Danish: Som vist i tabellen nedenfor forøgede Xoterna Breezhaler post-dosis dal-FEV1 med 200 ml sammenlignet med placebo ved det primære endepunkt (p<0,001) efter 26 uger, og viste statistisk signifikant forøgelse sammenlignet med såvel hver monoterapikomponent-behandlingsarm (indacaterol og glycopyrronium) som tiotropiumbehandlingsarmen.
English: 6 or 10 Xoterna Breezhaler capsules to be used in the inhaler
Danish: • Et eller flere blisterkort, som hver indeholder enten 6 eller 10 Xoterna Breezhaler kapsler til brug i inhalatoren
English: Empty remaining
Danish: Blisterk ort
English: How to store Xoterna Breezhaler Contents of the pack and other information Instructions for use of Xoterna Breezhaler inhaler
Danish: Pakningsstørrelser og yderligere oplysninger Brugsanvisning til Xoterna Breezhaler-inhalator
English: Xoterna Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment.
Danish: Xoterna Breezhaler kan bruges ved den anbefalede dosis hos patienter med let til moderat nedsat nyrefunktion.
English: SIA „Novartis Baltics“ Lietuvos filialas Tel: +370 5 269 16 50
Danish: Lietuva SIA „Novartis Baltics“ Lietuvos filialasTel: +370 5
English: Xoterna Breezhaler 85 mcg/43 mcg inhalation powder indacaterol/glycopyrronium
Danish: Xoterna Breezhaler 85 mikrog/43 mikrog inhalationspulver indacaterol/glycopyrronium
English: Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium
Danish: Xoterna Breezhaler 85 mikrogram/43 mikrogram inhalationspulver, hårde kapsler indacaterol/glycopyrronium
English: Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules
Danish: Xoterna Breezhaler 85 mikrogram/43 mikrogram, inhalationspulver, hårde kapsler
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.
Danish: Den blev indgivet i 4 dosistrin med en times mellemrum mellem hver dosis og sammenlignet med virkningen af placebo, indacaterol, glycopyrronium og salmeterol.
English: Xoterna Breezhaler showed similar adverse reactions to the individual components.
Danish: De samme bivirkninger blev observeret for Xoterna Breezhaler, som for de individuelle komponenter.
English: What Xoterna Breezhaler is and what it is used for What you need to know before you use Xoterna Breezhaler How to use Xoterna Breezhaler Possible side effects
Danish: Det skal du vide, før du begynder at tage Xoterna Breezhaler Sådan skal du tage Xoterna Breezhaler Bivirkninger
English: How long to continue your treatment with Xoterna Breezhaler Keep using Xoterna Breezhaler for as long as your doctor tells you.
Danish: Hvor længe skal du fortsætte med Xoterna Breezhaler-behandling
English: How to use Xoterna Breezhaler
Danish: Sådan skal du tage Xoterna Breezhaler
English: The usual dose is to inhale the content of one capsule each day.
Danish: Så meget Xoterna Breezhaler skal du tage Den sædvanlige dosis er inhalation af én kapsel dagligt.
English: (same class) to those in Xoterna Breezhaler (see section “Other medicines and Xoterna
Danish: - hvis du tager medicin mod din lungesygdom, som indeholder lignende aktive stoffer (samme klasse) som dem i Xoterna Breezhaler (se under ”Brug af anden medicin sammen med Xoterna
English: - Dispose of the inhaler ineach pack after all capsules in that pack have been used.
Danish: - Smid inhalatoren i hver pakning ud efter alle kapsler i pakningen er brugt.
English: 5 ml (2.4 mg/ml) 1 vial
Danish: Hætteglas (glas) 5 ml (2,4 mg/ml) 1 hætteglas
English: 12 mg Solution for injection
Danish: 12 mg Injektionsvæske, opløsning
English: MA (EU) Number
Danish: Markedsføringstillad elsesnummer (EU)
English: Immediate Packaging
Danish: Intratekal anvendelse
English: Therefore, it is unlikely that you will use too much.
Danish: Det er derfor usandsynligt, at du vil bruge for meget.
English: Black or African American
Danish: Sort eller afrikansk amerikaner
English: Examples of conditions which should be considered include, but are not limited to:
Danish: Eksempler på lidelser, som skal overvejes inkluderer, men er ikke begrænset til:
English: Confirm required number of devices.
Danish: Bekræft det påkrævede antal anordninger.
English: How much to use
Danish: Hvor meget skal du bruge
English: 24 hours Week 1 Week 2 Week 3 Week 4 Week 4
Danish: 24 timer Uge 1 Uge 2 Uge 3 Uge 4 Uge 4
English: Next device (if required)
Danish: Næste anordning (hvis påkrævet)
English: This will result in a loss of medicine.
Danish: Dette vil resultere i spild af medicin.
English: ● Check expiration date (‘EXP').
Danish: ● Kontrollér udløbsdatoen ("EXP").
English: LS mean difference (95% CI)†
Danish: LS mean forskel (95% CI)†
English: The need for continued treatment should be reexamined periodically.
Danish: Behovet for fortsat behandling skal jævnligt reevalueres.
English: ● Repeat Steps 2-5 if more than one device is required.
Danish: ● Gentag trin 2-5, hvis der er behov for mere end én anordning.
English: Do not use this medicine after the expiry date which is stated on the carton and the label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og etiketten.
English: From week 9:
Danish: Fra uge 9:
English: Dissociation (26%) was one of the most common psychological effects of esketamine.
Danish: Dissociation (26%) var en af esketamins mest almindelige psykologiske virkninger.
English: • Risk factors/groups/ signs of abuse and dependence, which should be regularly assessed and monitored;
Danish: • Risikofaktorer/-grupper/-tegn på misbrug og afhængighed, som skal vurderes og monitoreres jævnligt.
English: Do not give this medicine to children and adolescents younger than 18 years of age.
Danish: Denne medicin må ikke gives til børn og unge under 18 år.
English: Revised: {month YYYY}
Danish: Revideret: {måned ÅÅÅÅ}
English: Close supervision and monitoring should continue until the patient recovers.
Danish: Tæt observation og monitorering skal fortsætte, indtil patienten er kommet sig.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: Det er generel klinisk erfaring, at risikoen for selvmord kan stige i de tidlige stadier af bedring.
English: Subgroup analyses suggest limited efficacy in the population over 75 years old.
Danish: Undergruppeanalyser tyder på en begrænset virkning hos populationen på over 75 år.
English: Every other week Weekly or every other week 7 (7.8%)
Danish: Ugentligt eller hver anden uge 7 (7,8%)
English: Close monitoring is required for sedation and respiratory depression.
Danish: Tæt monitorering for sedation og respiratorisk depression er påkrævet.
English: ● increased sensitivity to noise or sounds
Danish: ● øget følsomhed over for støj eller lyde
English: ● Breathe in through nose while pushing plunger all the way up until it stops.
Danish: ● Trække vejret ind gennem næsen, mens stemplet skubbes hele vejen op, til det stopper.
English: LS mean change from baseline to end of week 4 (SE)
Danish: LS mean ændring fra baseline til slutningen af uge 4 (SE)
English: Weeks 5-8:
Danish: Uge 5-8:
English: The decision to prescribe Spravato should be determined by a psychiatrist.
Danish: Beslutningen om at ordinere Spravato skal afgøres af en psykiater.
English: • Which adverse effects to expect following SPRAVATO administration, and how to minimize those effects;
Danish: • Hvilke bivirkninger, der kan forventes efter administration af Spravato, og hvordan disse virkninger minimeres.
English: Recent (within 6 weeks) cardiovascular event, including myocardial infarction (MI).
Danish: Nylig (inden for 6 uger) kardiovaskulær hændelse, herunder myokardieinfarkt (MI).
English: In the case of overdose, the possibility of multiple medicinal products involvement should be considered.
Danish: I tilfælde af overdosering skal der tages hensyn til muligheden for, at der er flere lægemidler involveret.
English: ● Check indicator again to confirm device is empty.
Danish: ● Kontrollér indikatoren igen for at bekræfte, at anordningen er tom.
English: If you are elderly (>65 years), you will be carefully monitored as you may be at increased risk of falling when you start moving around after treatment.
Danish: Hvis du er ældre (> 65 år), vil du blive overvåget nøje, da du kan have øget risiko for at falde, når du begynder at bevæge dig rundt efter behandlingen.
English: Number of patients (%) Response rate
Danish: Antal patienter (%) Responsprocent