FrancophonIA/ELRC3.0 huggingface dataset:
English: SPRAVATO is intended to be self-administered by the patient under direct Healthcare Professional (HCP) supervision, and should be dispensed to the healthcare settings where administration takes place, as agreed at the MS level, based on local legal requirements and/or local healthcare systems.
Danish: Spravato er beregnet til, at patienten selv skal administrere det under direkte supervision af en sundhedsperson og skal udleveres til de klinikker, hvor administrationen finder sted efter aftale på medlemsstatsniveau og baseret på lokale lovkrav og/eller lokale sundhedssystemer.
English: No dose adjustment is necessary in patients with mild to severe renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til svært nedsat nyrefunktion.
English: Urinary tract and bladder symptoms have been reported with Spravato use (see section 4.8).
Danish: Urinvejs- og blæresymptomer er blevet rapporteret ved brug af Spravato (se pkt.
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.
Danish: I studierne med fleksible doser (TRD3002 og TRD3005) var optitreringen af Spravato-dosis baseret på en klinisk vurdering, og dosis kunne nedtitreres baseret på tolerabilitet.
English: ● Presence or history of psychosis;
Danish: ● Aktuel eller tidligere psykose.
English: This medicine is a clear, colourless solution, provided in a single-use nasal spray device.
Danish: Lægemidlet er en klar, farveløs opløsning, der leveres i en næsesprayanordning til engangsbrug.
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
Danish: Forskel (Spravato + oralt AD minus oralt AD + placebo næsespray) i least-squares mean ændring fra baseline Behandlingsgruppe som var statistisk signifikant overlegen i forhold til oralt AD + placebo næsespray Objektivt median estimat (dvs. vægtet kombination af LS means af forskellen fra oralt AD + placebo næsespray), og 95% fleksibelt konfidensinterval
English: ● nasal dryness including dry crusts in the nose
Danish: ● næsetørhed herunder skorpedannelser i næsen
English: Animal studies have shown that ketamine, the racemic mixture of arketamine and esketamine, induces neurotoxicity in developing foetuses (see section 5.3).
Danish: Dyreforsøg har vist, at ketamin, den racemiske blanding af arketamin og esketamin, inducerer neurotoksicitet i fostre under udvikling (se pkt.
English: CARTON (for 2 and 3 nasal spray devices)
Danish: KARTON (til 2 og 3 næsesprayanordninger)
English: 56 mg pack = 2 nasal spray devices 84 mg pack = 3 nasal spray devices
Danish: 56 mg pakning = 2 næsesprayanordninger 84 mg pakning = 3 næsesprayanordninger
English: Data in animals have shown excretion of esketamine in milk.
Danish: Data fra dyrestudier har vist, at esketamin udskilles i mælk.
English: ● feeling irritable
Danish: ● du føler dig irritabel
English: Excipients: Citric acid monohydrate, disodium edetate, sodium hydroxide, water for injections.
Danish: Hjælpestoffer: Citronsyremonohydrat, dinatriumedetat, natriumhydroxid, vand til injektionsvæsker.
English: Patients who require a nasal corticosteroid or nasal decongestant on a dosing day should be advised not to administer these medicinal products within 1 hour before Spravato administration.
Danish: Nasalt kortikosteroid eller nasal dekongestant Patienter, der har behov for nasale kortikosteroider eller nasale dekongestanter på dagen for doseringen, skal rådes til om ikke at tage disse lægemidler indenfor 1 time før Spravatoadministrationen.
English: The mean absolute bioavailability of 84 mg esketamine administered as a nasal spray is approximately
Danish: Den gennemsnitlige absolutte biotilgængelighed af 84 mg esketamin administreret som næsespray er ca. 48 %.
English: ● Presence or history of mania or bipolar disorder;
Danish: ● Aktuel eller tidligere mani eller bipolar lidelse.
English: These patients should be clinically stable and cardiac symptom free prior to administration;
Danish: ● Patienter med MI i anamnesen skal være klinisk stabile og fri for kardielle symptomer før administration af dosen.
English: The filled and stoppered vial is assembled into a manually-activated nasal spray device.
Danish: Det fyldte og tilproppede hætteglas er monteret i en manuelt aktiveret næsesprayanordning.
English: CARTON (for 1 and 6 nasal spray devices)
Danish: KARTON (til 1 og 6 næsesprayanordninger)
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.
Danish: De gennemsnitlige Cmax- og AUC∞-værdier for esketamin i plasma, der fremkaldtes af en enkelt dosis på 56 mg esketamin var henholdsvis cirka 14% og 33% højere hos kinesiske forsøgspersoner sammenlignet med kaukasiere.
English: • Requirements for HCP supervision and post-dose observation, until the HCP confirms the patient is clinically stable and is allowed to leave the clinic/facility where SPRAVATO has been administered;
Danish: • Kravet om opsyn og observation foretaget af en sundhedsperson efter dosering, indtil sundhedspersonen bekræfter, at patienten er klinisk stabil og kan tillades at forlade den klinik/facilitet, hvor Spravato blev administreret.
English: SPRAVATO may induce transient sedation, dissociative and perception disorders and/or hypertension.
Danish: Spravato kan inducere forbigående sedation, dissociative lidelser og perceptionsforstyrrelser og/eller hypertension.
English: There is no clinical experience with esketamine administered as a nasal spray in patients on dialysis.
Danish: Der er ingen klinisk erfaring med esketamin administreret som næsespray hos patienter i dialyse.
English: ● feeling abnormal
Danish: ● unormal følelse
English: Each nasal spray device is individually packaged in a sealed blister.
Danish: Hver enkelt næsesprayanordning er pakket individuelt i en forseglet blister.
English: 84 mg = 3 devices
Danish: 84 mg = 3 anordninger
English: o The guide for patients, aiming at addressing the risks of transient dissociative states and perception disorders, drug abuse, disturbances in consciousness and blood pressure increased.
Danish: o Vejledningen til patienter, som har til formål at adressere risiciene for forbigående dissociative tilstande og opfattelsesforstyrrelser, stofmisbrug, bevidsthedsforstyrrelser og forhøjet blodtryk.
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.
Danish: Spravato næsesprays virkning og sikkerhed blev undersøgt i fem kliniske fase 3-studier hos voksne patienter (18 til 86 år) med behandlingsresistent depression (BRD), som opfyldte DSM-5-kriterierne for klinisk depression, og som ikke havde responderet på behandling med mindst to orale antidepressiva (AD'er) med passende dosering og varighed under den igangværende svære depressionsepisode.
English: What Spravato is used for
Danish: Hvad anvendes Spravato til
English: Psychiatric disorders dissociation euphoric mood, agitation, anxiety, illusion, irritability, panic attack, time perception altered, hallucination including visual hallucination, derealisation
Danish: Psykiske forstyrrelser dissociation euforisk stemning, agitation, angstanfald, illusion, irritabilitet, panikangst, ændret tidsopfattelse, hallucinationer herunder synshallucinationer, derealisation
English: You will use the Spravato nasal spray yourself - under the supervision of your doctor or other healthcare professional in a healthcare setting, such as, the doctor's office or clinic.
Danish: Du skal selv bruge Spravato næsesprayen - men under opsyn af din læge eller en anden sundhedsperson i lægens konsultation eller på en klinik.
English: The pharmacokinetics of a single, 56-mg dose of esketamine administered as a nasal spray was similar in subjects with allergic rhinitis who were exposed to grass pollen compared to healthy subjects.
Danish: Farmakokinetikken for en enkelt dosis på 56 mg esketamin administreret som næsespray var ensartet hos forsøgspersoner med allergisk rhinitis som blev eksponeret for græspollen sammenlignet med raske forsøgspersoner.
English: Patients with clinically significant or unstable cardiovascular or respiratory conditions
Danish: Patienter med klinisk signifikante eller ustabile hjerte-kar- eller respirationslidelser
English: In the flexible dose study TRD3002, at day 28, 67% of the patients randomised to Spravato were on 84 mg.
Danish: I studiet TRD3002 med fleksibel dosis var 67% af de patienter, der var blevet randomiseret til Spravato, på 84 mg på dag 28.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Spravato therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Spravato seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: 56 mg = 2 devices
Danish: 56 mg = 2 anordninger
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).
Danish: Blodtrykket skal overvåges nøje ved brug af Spravato sammen med psykostimulantia (f. eks. amfetamin, methylphenidat, modafanil, armodafinil) eller andre lægemidler, der kan øge blodtrykket (f. eks. xanthinderivater, ergometrin, thyreoideahormoner, vasopressin, eller MAO-hæmmere, som f.eks. tranylcypromin, selegitin, phenelzin).
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.
Danish: Sammenlignet med den anbefalede dosis var bivirkningerne i forbindelse med dosen på 112 mg esketamin næsespray dog hyppigere, herunder svimmelhed, hyperhidrose, somnolens, hypoæstesi, unormal følelse, kvalme og opkastning.
English: This device is intended for administration by the patient, under supervision of a healthcare professional.
Danish: Denne anordning er beregnet til at blive administreret af patienten selv, under supervision af en sundhedsperson.
English: The pharmacokinetics of esketamine nasal spray was compared between healthy Asian subjects and Caucasian subjects.
Danish: Farmakokinetikken for esketamin næsespray blev sammenlignet mellem raske asiatiske og kaukasiske forsøgspersoner.
English: o The “Readiness for a patient to leave the healthcare setting” checklist for HCPs (attached to the HCP guide): the objective of this EM is to aid HCPs in evaluating when, following SPRAVATO administration, a patient is deemed stable and safely allowed to leave the clinic/facility where SPRAVATO has been administered.
Danish: o ”Tjeklisten for patientens parathed til at forlade klinikken” til sundhedspersoner (vedhæftet vejledningen til sundhedspersoner): Målet med dette uddannelsesmateriale er at hjælpe sundhedspersoner med at evaluere, hvornår en patient skønnes at være stabil efter administration af Spravato, og sikkert kan tillades at forlade den klinik/facilitet, hvor Spravato blev administreret.
English: Do not blow nose.
Danish: Undlad at pudse næse.
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.
Danish: Hyppigheden af markant abnorme blodtryksstigninger for SBT (stigning på ≥ 40 mmHg) spændte fra 8 % (< 65 år) til 17 % (≥ 65 år) og for DBT (stigning på ≥ 25 mmHg) spændte fra 13 % (< 65 år) til 14 % (≥ 65 år) hos patienter som fik esketamin samt oralt antidepressivum.
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.
Danish: ● Lægemidler, som får dit blodtryk til at stige som f.eks. skjoldbruskhormoner, lægemidler mod astma som f.eks. xanthinderivater, lægemidler mod blødning under fødsel (ergometrin) og hjertemedicin som f.eks. vasopressin.
English: • The steps for SPRAVATO self-administration under direct HCP supervision;
Danish: • Trinnene til selvadministration af Spravato under direkte opsyn af sundhedspersoner.
English: No dose adjustment is necessary in patients with mild (Child Pugh class A) or moderate (Child Pugh class B) hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (Child-Pugh klasse A) eller moderat nedsat leverfunktion (Child-Pugh klasse B).
English: ● Medicines for depression or Parkinson's disease known as monoamine oxidase inhibitors (MAOIs) (for example, tranylcypromine, selegiline, phenelzine).
Danish: ● Lægemidler mod depression eller Parkinsons sygdom også kendt som monoaminooxidasehæmmere (MAO-hæmmere) (f.eks. tranylcypromin, selegilin, phenelzin).
English: The device dispenses two sprays.
Danish: Anordningen afgiver to pust.
English: ● change in sense of taste
Danish: ● ændringer i smagssansen
English: Treatment group
Danish: Behandlings gruppe
English: Following intravenous administration of radiolabelled esketamine, approximately 78% and 2% of administered radioactivity was recovered in urine and faeces, respectively.
Danish: Efter intravenøs administration af radioaktivt mærket esketamin blev ca. 78% og 2% af den administrerede radioaktivitet genfundet i henholdsvis urin og fæces.
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.
Danish: I forhold til forsøgspersoner med normal nyrefunktion (kreatininclearance [CLCR], 88 til 140 ml/min) var Cmax for esketamin i gennemsnit 20 til 26% højere hos forsøgspersoner med let nedsat (CLCR, 58 til 77 ml/min), moderat nedsat (CLCR, 30 til 47 ml/min) eller svært nedsat (CLCR, 5 til 28 ml/min, ikke i dialyse) nyrefunktion efter administration af en dosis på 28 mg af esketamin næsespray.
English: Vascular disorders hypertension
Danish: Vaskulære sygdomme hypertension
English: ● Stimulants such as those used for conditions such as narcolepsy or medicines for ADHD (for example, amphetamines, methylphenidate, modafanil, armodafinil)
Danish: ● Stimulerende midler såsom dem, der anvendes til sygdomme som narkolepsi eller lægemidler mod ADHD (f.eks. amfetaminer, methylphenidat, modafanil, armodafinil)
English: Response was defined as ≥ 50% reduction in the MADRS total score from baseline Remission was defined as MADRS total score ≤ 12
Danish: Respons blev defineret som ≥ 50% reduktion i den samlede MADRS-score fra baseline Remission blev defineret som en samlet MADRS-score ≤ 12
English: NASAL SPRAY/DEVICE LABEL
Danish: NÆSESPRAY/ETIKET PÅ ANORDNINGEN
English: Following oral administration of radiolabelled esketamine, approximately 86% and 2% of administered radioactivity was recovered in urine and faeces, respectively.
Danish: Efter oral administration af radioaktivt mærket esketamin blev ca. 86% og 2% af den administrerede radioaktivitet genfundet i henholdsvis urin og fæces.
English: What Spravato is
Danish: Hvad er Spravato
English: Each nasal spray device contains esketamine hydrochloride corresponding to 28 mg esketamine.
Danish: Hver næsesprayanordning indeholder esketaminhydrochlorid svarende til 28 mg esketamin.
English: Only initiate treatment with Spravato in patients with clinically significant or unstable cardiovascular or respiratory conditions if the benefit outweighs the risk.
Danish: Behandlingen med Spravato bør kun igangsættes hos patienter med klinisk signifikante eller ustabile hjerte-kar- eller respirationssygdomme, hvis fordelen opvejer risikoen.
English: What you need to know before you use Spravato
Danish: Det skal du vide, før du begynder at bruge Spravato
English: ● nausea
Danish: ● kvalme
English: Spravato is intended to be self-administered by the patient under the direct supervision of a healthcare professional.
Danish: Spravato er beregnet til selvadministration af patienten under direkte supervision af en sundhedsperson.
English: Cognitive and memory impairment have been reported with long-term ketamine use or drug abuse.
Danish: Kognitive og hukommelsesrelaterede forstyrrelser er blevet rapporteret i forbindelse med langvarig brug eller misbrug af ketamin.
English: Patients with clinically significant or unstable cardiovascular or respiratory conditions require additional precautions.
Danish: Patienter med klinisk signifikante eller ustabile hjerte-kar- eller respirationssygdomme kræver yderligere forholdsregler.
English: 28 mg per device
Danish: 28 mg pr. anordning
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.
Danish: I et studie af misbrugspotentialet udført hos flerstofs-fritidsmisbrugere (n=41) fremkaldte enkelte doser af esketamin næsespray (84 mg og 112 mg) og det positive kontrollægemiddel, intravenøst ketamin (0,5 mg/kg infunderet over 40 minutter), signifikant højere scores end placebo på subjektiv vurdering af "drug liking" og andre mål for subjektive stofvirkninger.
English: The terminal half-life of esketamine was not affected by ticlopidine pre-treatment.
Danish: Esketamins terminale halveringstid blev ikke påvirket af forbehandling med ticlopidin.
English: After dosing with Spravato, blood pressure should be reassessed at approximately 40 minutes and subsequently as clinically warranted (see section 4.4).
Danish: Efter dosering med Spravato skal blodtrykket revurderes efter ca. 40 minuter og efterfølgende som det findes klinisk relevant (se pkt.
English: ● spinning sensation (“vertigo”)
Danish: ● du føler, at det hele drejer rundt ("vertigo")
English: One device contains 2 sprays (1 spray for each nostril)
Danish: Hver anordning indeholder 2 pust (1 pust i hvert næsebor)
English: In an embryo foetal developmental toxicity study with nasally administered ketamine in rabbits, skeletal malformations were observed and foetal body weight was reduced at maternally toxic doses.
Danish: I et embryoføtalt udviklingstoksicitetsstudie med nasalt administreret ketamin hos kaniner, sås der skeletmalformationer, og den føtale legemsvægt var reduceret ved maternelt toksiske doser.
English: Table 3: Recommended Dosing for Spravato in Adults of Japanese Ancestry Induction phase
Danish: Tabel 3: Anbefalet dosering af Spravato hos voksne af japansk afstamning Induktionsfase
English: Response and remission rates
Danish: Respons- og remissionsprocenter
English: Spravato should not be administered if an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.3).
Danish: Spravato må ikke administreres, hvis en stigning i blodtryk eller intrakranielt tryk udgør en alvorlig risiko (se pkt.
English: The terminal half-life of esketamine was similar in the elderly and younger adult subjects (see section 4.2).
Danish: Esketamins terminale halveringstid var ensartet hos ældre og yngre forsøgspersoner (se pkt.
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).
Danish: Baseret på reduktionen i den samlede MADRS-score fra baseline var andelen af patienter i studierne TRD3001, TRD3002 og TRD3005, som udviste respons på behandling med Spravato plus oralt AD, større end for oralt AD plus placebo næsespray gennem hele den 4 uger lange dobbeltblinde induktionsfase (tabel 6).
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.
Danish: I kliniske studier med esketamin var der ingen tilfælde af interstitiel cystitis, men der blev dog observeret en højere forekomst af nedre urinvejssymptomer (pollaksuri, dysuri, akut vandladningsbehov, nykturi og cystitis) hos esketamin-behandlede patienter sammenlignet med placebo-behandlede patienter.
English: Stable remission
Danish: Stabil remission
English: The terminal half-life of esketamine was not affected by clarithromycin pre-treatment.
Danish: Esketamins terminale halveringstid blev ikke påvirket af forbehandling med clarithromycin.
English: Nervous system disorders dizziness, headache, dysgeusia, somnolence, hypoaesthesia mental impairment, tremor, lethargy, dysarthria, paraesthesia, sedation
Danish: Nervesystemet svimmelhed, hovedpine, dysgeusi, somnolens, hypæstesi mental svækkelse, tremor, letargi, dysartri, paræstesi, sedation
English: Administration of a comparable supratherapeutic dose of esketamine by the intranasal route is unlikely to be feasible.
Danish: Det er ikke sandsynligt, at nasal administration af en sammenlignelig supraterapeutisk dosis af esketamin vil kunne forekomme.
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).
Danish: I kliniske forsøg var stigninger i systolisk og diastolisk blodtryk (SBT og DBT) over tid omkring 7 til 9 mmHg for SBT og 4 til 6 mmHg for DBT 40 minutter efter dosering og 2 til 5 mmHg for SBT og 1 til 3 mmHg for DBT 1,5 time efter dosering hos patienter, der fik Spravato plus orale antidepressiva (se pkt.
English: Citric acid monohydrate Disodium edetate
Danish: Citronsyremonohydrat Dinatriumedetat
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.
Danish: Intravenøst administreret esketamin var imidlertid helt uden genotoksiske egenskaber i en in vivo knoglemarvs mikronukleustest hos rotter og en in vivo Comet-analyse i rotteleverceller.
English: Respiratory, thoracic and mediastinal disorders nasal discomfort, nasal dryness including nasal crusting, nasal pruritus
Danish: Luftveje, thorax og mediastinum nasalt ubehag, nasal tørhed herunder nasal skorpedannelse, nasal pruritus
English: Spravato + Oral AD (N=90)
Danish: Spravato + oralt AD (N=90)
English: Instructions for Use SPRAVATO (esketamine) Nasal Spray Device
Danish: Brugsanvisning SPRAVATO (esketamin) Næsesprayanordning