FrancophonIA/ELRC3.0 huggingface dataset:
English: If more than 2 treatment sessions have been missed, per clinical judgment, adjustment of the dose or frequency of Spravato may be clinically appropriate.
Danish: Hvis flere end 2 behandlingssessioner er blevet forpasset, kan det være klinisk relevant at justere dosis eller hyppigheden af Spravato-behandlingen i henhold til en klinisk vurdering.
English: After Cmax was reached following nasal administration, the decline in esketamine concentrations in plasma was rapid for the first few hours and then more gradual.
Danish: Efter Cmax blev nået efter nasal administration, faldt esketaminkoncentrationen i plasma hurtigt i de første par timer, hvorefter den faldt mere gradvist.
English: Exposure numbers were influenced by the study stopping at a pre-determined number of relapses based on the interim analysis.
Danish: Tallene for eksponering blev påvirkedes af, at studiet blev afbrudt ved et på forhånd bestemt antal tilbagefald baseret på interimanalysen.
English: The degree to which esketamine is bound to plasma proteins is not dependent on hepatic or renal function.
Danish: Graden, hvorved esketamin bindes til plasmaproteiner, afhænger ikke af lever- eller nyrefunktionen.
English: These effects did not increase over time and were reversible after discontinuing ketamine.
Danish: Disse virkninger øgedes ikke over tid og remitterede efter seponering af ketamin.
English: ● difficulty with your attention, judgment and thinking (see also “Driving and using machines” and “Possible side effects”).
Danish: ● problemer med din opmærksomhed, dømmekraft og tankevirksomhed (se også "Trafik- og arbejdssikkerhed" og "Bivirkninger").
English: Overall a total of 705 patients were enrolled; 437 directly enrolled; 150 transferred from TRD3001, and 118 transferred from TRD3002.
Danish: I alt blev der rekrutteret 705 patienter: 437 blev rekrutteret direkte, 150 blev overført fra TRD3001 og 118 blev overført fra TRD3002.
English: Published studies in animals (including primates) at doses resulting in light to moderate anaesthesia demonstrate that the use of anaesthetic agents during the period of rapid brain growth or synaptogenesis results in cell loss in the developing brain, that can be associated with prolonged cognitive deficiencies.
Danish: Publicerede dyrestudier (herunder primater) ved doser, der resulterer i let til moderat anæstesi, viser, at brugen af anæstesimidler under perioden med hurtig hjernevækst eller synaptogenese resulterer i celletab i den udviklende hjerne, hvilket kan være forbundet med langvarige kognitive mangler.
English: ● frequent need to pass urine
Danish: ● hyppigt behov for at lade vandet
English: Tell the medical staff right away if your feel like you cannot stay awake or if you feel like you are going to pass out.
Danish: Fortæl det straks til sundhedspersonalet, hvis du føler, at du ikke kan holde dig vågen, eller hvis du føler, at du er ved at besvime.
English: Using Spravato with certain medicines may cause side effects.
Danish: Hvis du bruger Spravato sammen med visse andre lægemidler, kan det give bivirkninger.
English: The incidence of increased SBP (≥ 180 mmHg) was 3% and DBP (≥ 110 mmHg) was
Danish: Forekomsten af stigningen i SBT (≥ 180 mmHg) var 3 %, og DBT (≥ 110 mmHg) var 4 %.
English: In all short-term studies, the primary efficacy endpoint was change in MADRS total score from baseline to day 28.
Danish: I alle korttidsstudierne var det primær effektendepunkt ændring i samlet MADRS-score fra baseline til dag 28.
English: Table 5: Primary efficacy results for change in MADRS total score for 4-week clinical trials (ANCOVA BOCF)
Danish: Tabel 5: Primære effektresultater for ændring i samlet MADRS-score i de 4 uger lange kliniske forsøg (ANCOVA BOCF)
English: Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants, ATC code: N06AX27.
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptika, andre antidepressiva, ATC-kode: N06AX27.
English: Read these Instructions for Use in full before training and supervising patient.
Danish: Læs hele denne brugsanvisning, før du oplærer og superviserer patienter.
English: ● Nose rest should touch the skin between the nostrils.
Danish: ● Næsekraven skal berøre huden mellem næseborene.
English: Patient sprays once into each nostril
Danish: Patienten puster én gang i hvert næsebor
English: ● Do not press the plunger.
Danish: ● Tryk ikke på stemplet.
English: ● After the first 4 weeks, Spravato is usually used once a week
Danish: ● Efter de første 4 uger bruges Spravato normalt én gang ugentligt
English: If you see a green dot, have patient spray again into the second nostril.
Danish: Hvis der vises en grøn prik, skal patient puste igen i det andet næsebor.
English: Prior oral antidepressants with nonresponse (i.e., failed antidepressants) Number of specific antidepressants, n (%)
Danish: Tidligere orale antidepressiva med manglende respons (dvs. antidepressiva med udebleven virkning) Antal specifikke antidepressiva, n (%)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL ANORDNINGER
English: Neuropsychiatric and motor impairments
Danish: Neuropsykiatriske og motoriske forstyrrelser
English: Tell your doctor or go to the nearest hospital straight away if you have thoughts of harming or killing yourself at any time.
Danish: Kontakt straks lægen eller nærmeste hospital, hvis du har tanker om at skade dig selv eller begå selvmord.
English: • The influence of SPRAVATO on the patient's ability to drive or operate machinery
Danish: • Indvirkningen af Spravato på patientens evne til at køre bil eller betjene maskiner
English: ● pain when urinating or seeing blood in your urine - these could be signs of bladder problems.
Danish: ● smertefuld vandladning eller blod i urinen - dette kan være tegn på problemer med blæren.
English: 2 green dots (0 mg delivered)
Danish: 2 grønne prikker (0 mg afgivet)
English: ● feeling of body temperature change
Danish: ● du føler at din kropstemperatur ændrer sig
English: Table 6: Response and remission rates in 4-week clinical trials based on BOCF data
Danish: Tabel 6: Respons- og remissionsprocenter i 4-uger lange kliniske forsøg baseret på BOCF-data
English: • Monitoring of blood pressure before and after SPRAVATO dosing;
Danish: • Monitorering af blodtrykket før og efter dosering af Spravato.
English: At the end of the open label induction phase, 52% of patients were in remission (MADRS total score ≤ 12) and 66% of patients were responders (≥ 50% improvement in MADRS total score).
Danish: Ved afslutningen af den ublindede induktionsfase var 52% af patienterne i remission (samlet MADRS-score ≤ 12), og 66% af patienterne responderede (≥ 50% forbedring i samlet MADRS-score).
English: If you are not sure, talk to your doctor before using Spravato - your doctor will decide whether or not you can use this medicine.
Danish: Hvis du ikke er sikker, skal du tale med lægen, før du bruger Spravato - lægen vil beslutte om du kan bruge dette lægemiddel eller ej.
English: Animal studies with ketamine showed evidence of developmental neurotoxicity.
Danish: Dyreforsøg med ketamin viste tegn på udviklingsmæssig neurotoksicitet.
English: Remission was defined as a MADRS total score ≤ 12.
Danish: Remission blev defineret som en samlet MADRS-score ≤ 12.
English: The dose recommendations for Spravato are shown in Table 1 and Table 2 (adults ≥65 years).
Danish: Dosisanbefalingerne for Spravato er vist i tabel 1 og tabel 2 (voksne ≥ 65 år).
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.
Danish: Esketamin hæmmer ikke disse transportører eller multi-drug- og toksinekstrudering 1 (MATE1) og MATE2-K eller organisk kationtransportør 2 (OCT2), OAT1 eller OAT3.
English: The mean terminal half-life following administration as a nasal spray generally ranged from 7 to 12 hours.
Danish: Den gennemsnitlige terminale halveringstid efter administration som næsespray varierede generelt fra 7 til 12 timer.
English: ● eyes, ears, or sense of touch are deceived or tricked in some way (something is not what it seems to be)
Danish: ● dine øjne, ører eller følesans fupper eller snyder dig på en eller anden måde (der er noget der ikke er, som det ser ud til at være)
English: Restoration of dopaminergic neurotransmission in brain regions involved in the reward and motivation, and decreased stimulation of brain regions involved in anhedonia, may contribute to the rapid response.
Danish: Genetableringen af dopaminerg neurotransmission i de områder af hjernen, der er involveret i belønning og motivation og nedsat stimulering af de områder i hjernen, der er involveret i anhedoni, bidrager muligvis til det hurtige respons.
English: Some patients using Spravato may experience nausea or vomiting.
Danish: Nogle patienter, der bruger Spravato, kan opleve kvalme eller opkastning.
English: The mean terminal half-life of esketamine in the plasma of Asian subjects ranged from 7.1 to 8.9 hours and was 6.8 hours in Caucasian subjects.
Danish: Den gennemsnitlige terminale halveringstid i plasma hos asiatiske forsøgspersoner spændte fra 7,1 til 8,9 timer, mens den var 6,8 timer hos kaukasiske forsøgspersoner.
English: ● Spravato is usually used twice a week for the first 4 weeks
Danish: ● Spravato bruges normalt to gange ugentligt i de første 4 uger
English: Confirm delivery and rest
Danish: Bekræftelse af afgivelsen og hvile
English: This medicine may cause a temporary increase in your blood pressure after taking a dose.
Danish: Dette lægemiddel kan give anledning til en midlertidig blodtryksstigning efter brug af en dosis.
English: There is no specific antidote for esketamine overdose.
Danish: Der findes intet specifikt antidot mod overdosering med esketamin.
English: In long-term clinical trials, the effect of esketamine nasal spray on cognitive functioning was evaluated over time and performance remained stable.
Danish: I langvarige kliniske forsøg blev virkningen af esketamin næsespray på den kognitive funktion evalueret over tid, og funktionen forblev stabil.
English: Indicator
Danish: Indikator
English: Other populations at risk
Danish: Andre risikopopulationer
English: ● decreased feeling or sensitivity, including around the mouth area
Danish: ● nedsat følesans eller følsomhed, herunder i området omkring munden
English: 3 or more Newly initiated oral antidepressant medication initiated at randomisation, n (%) SNRI SSRI Withdrawn from study (for any reason), n/N (%)
Danish: 3 eller flere Nyligt initieret antidepressivt lægemiddel initieret ved randomisering, n (%) SNRI SSRI Trukket ud af studiet (uanset årsag) n/N (%)
English: ● History of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure.
Danish: ● Anamnese med hjerneskade, hypertensiv encefalopati, intratekal behandling med ventrikulære shunts eller en hvilken som helst anden tilstand, der er associeret med forhøjet intrakranielt tryk.
English: Management of Spravato overdose should consist of treating clinical symptoms and relevant monitoring.
Danish: Behandling af overdosering med Spravato bør omfatte behandling af de kliniske symptomer og relevant monotorering.
English: The following EM should be provided to HCPs (and acknowledgement of receipt recorded):
Danish: Følgende uddannelsesmateriale skal udleveres til sundhedspersoner (og bekræftelse af modtagelsen skal registreres):
English: After an initial 16 weeks of treatment with Spravato plus oral AD, the median duration of exposure to Spravato in the maintenance phase was 4.2 months (range: 1 day to 21.2 months) in Spravato -treated patients (stable remission and stable response).
Danish: Efter de indledende 16 ugers behandling med Spravato plus oralt AD var den gennemsnitlige varighed af eksponeringen for Spravato i vedligeholdelsesfasen 4,2 måneder (Interval: 1 dag til 21,2 måneder) hos Spravato-behandlede patienter (stabil remission og stabilt respons).
English: Use of the same nostril for 2 consecutive sprays If administration in the same nostril occurs, a replacement device should not be used.
Danish: Anvendelse af det samme næsebor til 2 på hinanden følgende pust Hvis administration foretages i det samme næsebor, må der ikke anvendes en erstatningsanordning.
English: ● feeling drunk
Danish: ● du føler dig beruset
English: ● seeing, feeling, hearing or smelling things that are not there (hallucinations)
Danish: ● du ser, føler, hører eller lugter ting, som ikke er der (hallucinationer)
English: Before Spravato administration, patients should be instructed not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a vehicle or operating machinery, until the next day following a restful sleep (see section 4.4).
Danish: Før administration af Spravato skal patienten instrueres i ikke at involvere sig i potentielt farlige aktiviteter, der kræver fuld mental årvågenhed og motorisk koordination, som f.eks. at køre bil eller betjene maskiner, indtil næste dag efter en god nats søvn (se pkt.
English: If a woman becomes pregnant while being treated with Spravato, treatment should be discontinued, and the patient should be counselled about the potential risk to the foetus and clinical/therapeutic options as soon as possible.
Danish: Hvis en kvinde bliver gravid, mens hun er i behandling med Spravato, skal behandlingen afbrydes, og patienten skal snarest muligt rådgives om den potentielle risiko for fostret og de kliniske/behandlingsmæssige muligheder.
English: Relapse was defined as a MADRS total score ≥ 22 for 2 consecutive weeks or hospitalisation for worsening depression or any other clinically relevant event indicative of relapse.
Danish: tilbagefald blev defineret som en samlet MADRS-score ≥ 22 i 2 på hinanden følgende uger eller hospitalsindlæggelse på grund af forværring af depressionen eller andre klinisk relevante hændelser, der kan indikere tilbagefald.
English: ● Significant pulmonary insufficiency, including COPD;
Danish: ● Signifikant lungeinsufficiens, herunder KOL.
English: SD = standard deviation; SE = standard error; LS Mean = least-squares mean; CI = confidence interval; AD = antidepressant
Danish: SD = standardafvigelse; SE = standardfejl; LS Mean = least-squares mean (mindste kvadraters gennemsnit); CI = konfidensinterval; AD = antidepressivum
English: Do not use Spravato
Danish: Brug ikke Spravato
English: The mean steady-state volume of distribution of esketamine administered by the intravenous route is 709 L.
Danish: Gennemsnitlig steady-state fordelingsvolumen for esketamin administreret intravenøst er 709 l.
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.
Danish: Esketamin er ikke et substrat for transportørerne p-glykoprotein (P-gp; multidrug-resistensprotein 1), brystcancer-resistensprotein (BCRP) eller organisk aniontransportør (OATP) 1B1 eller OATP1B3.
English: Drug abuse, dependence, withdrawal
Danish: Stofmisbrug, afhængighed, abstinenser
English: No significant differences in the pharmacokinetics of esketamine nasal spray were observed for gender and total body weight (> 39 to 170 kg) based on population PK analysis.
Danish: Der sås ingen signifikante forskelle i farmakokinetikken for esketamin næsespray afhængig af køn og samlet legemsvægt (> 39 til 170 kg) baseret på farmakokinetisk populationsanalyse.
English: The potential for abuse, misuse and diversion of Spravato is minimised due to the administration taking place under the direct supervision of a healthcare professional.
Danish: Potentialet for misbrug, forkert brug eller diversion af Spravato er minimalt, da administrationen finder sted under supervision af en sundhedsperson.
English: ● if you have ever had certain conditions such as: an aneurysm (a weak spot in a blood vessel wall where it widens or bulges out) bleeding in the brain
Danish: ● hvis du nogensinde har haft visse sygdomme som f.eks.: en "aneurisme" (et svagt punkt i en blodåre, hvor den udvides eller buler ud) blødning i hjernen
English: Spravato is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Spravato frarådes under graviditet og til kvinder i den fertile alder, som ikke anvender kontraception.
English: The main cytochrome P450 (CYP) enzymes responsible for esketamine N-demethylation are CYP2B6 and CYP3A4.
Danish: P450 (CYP) -enzymer, der er ansvarlige for esketaminets N-demetylering, er CYP2B6 og CYP3A4.
English: Life-threatening symptoms are expected based on experience with ketamine given at 25-fold the usual anaesthetic dose.
Danish: Livstruende symptomer må forventes baseret på erfaringen med ketamin givet i en dosis på 25 gange den normale i forbindelse med anæstesi.
English: The pharmacokinetic profile of esketamine is similar after a single dose and repeat dose administration with no accumulation in plasma when esketamine is administered twice a week.
Danish: Esketamins farmakokinetiske profil er uændret efter en enkelt dosis og efter administration af gentagne doser uden akkumulering i plasma, når esketamin administreres to gange ugentligt.
English: Esketamine is rapidly absorbed by the nasal mucosa following nasal administration and can be measured in plasma within 7 minutes following a 28 mg dose.
Danish: Esketamin absorberes hurtigt via slimhinden i næsen efter nasal administration og kan måles i plasma inden for 7 minutter efter en dosis på 28 mg.
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.
Danish: Den er beregnet til selvadministration af patienten under direkte supervision af en sundhedsperson under anvendelse af 1 anordning (til en dosis på 28 mg), 2 anordninger (til en dosis på 56 mg) eller 3 anordninger (til en dosis på 84 mg) med en hvileperiode på 5 minutter mellem anvendelsen af hver anordning.
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.
Danish: Studierne TRANSFORM-1 (TRD3001) og TRANSFORM-2 (TRD3002) blev udført hos voksne (18 til < 65 år), og studiet TRANSFORM-3 (TRD3005) blev udført hos voksne ≥ 65 år.
English: Spravato is used in adults to reduce the symptoms of depression, such as, feeling sad, anxious, or worthless, sleeping difficulties, change in appetite, loss of interest in favourite activities, feeling of being slowed down.
Danish: Spravato anvendes til voksne til at lette symptomer på depression som f.eks. at føle sig trist, ængstelig eller værdiløs, søvnbesvær, appetitændringer, tab af interesse i yndlingsaktiviteter, følelse af at alt går langsommere.
English: Concomitant use of Spravato with CNS depressants (e.g., benzodiazepines, opioids, alcohol) may increase sedation, which therefore should be closely monitored.
Danish: Samtidig brug af Spravato og CNS-depressiva (f.eks. benzodiazepiner, opioider, alkohol) kan øge den sederende effekt, hvilket derfor skal overvåges nøje.
English: When the administration is intended for outpatients, it should only be reserved to an environment where the patient is appropriately followed-up.
Danish: Når administrationen er beregnet til ambulante patienter, skal den være forbeholdt til et sted, hvor der kan følges korrekt op på patienten.
English: Dissociation symptoms typically resolved by 1.5 hours post-dose and the severity tended to reduce over time with repeated treatments.
Danish: Symptomerne på dissociation remitterede typisk inden for 1,5 time efter doseringen, og sværhedsgraden viste en nedadgående tendens over tid med gentagne behandlinger.
English: During and after each use of this medicine, your doctor will check you and decide how long to monitor you.
Danish: Under og efter hver brug af dette lægemiddel vil din læge kontrollere dig og beslutte, hvor længe du skal holdes under opsyn.
English: 1 green dot
Danish: 1 grøn prik
English: Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of Spravato.
Danish: Personer med stofmisbrug eller afhængighed i anamnesen kan have større risiko for misbrug eller forkert brug af Spravato.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: The maximum single esketamine nasal spray dose tested in healthy volunteers was 112 mg which showed no evidence of toxicity and/or adverse clinical outcomes.
Danish: Den maksimale enkeltdosis af esketamin næsespray, der er blevet testet hos raske frivillige, var 112 mg som ikke viste nogen tegn på toksicitet og/eller negative kliniske resultater.
English: Cognitive and memory impairment
Danish: Kognitive og hukommelsesrelaterede forstyrrelser
English: ● Medicines used to treat nervous disorders or severe pain (for example, benzodiazepines, opioids), or medicines or beverages containing alcohol
Danish: ● Lægemidler, som bruges til at behandle forstyrrelser af nervesystemet eller kraftige smerter (f.eks. benzodiazepiner, opioider), eller lægemidler eller drikkevarer, der indeholder alkohol
English: Assessment before treatment Prior to dosing with Spravato blood pressure should be assessed.
Danish: Vurdering inden behandling Inden dosering med Spravato skal blodtrykket vurderes.
English: These patients should be carefully assessed before prescribing Spravato and treatment initiated only if the benefit outweighs the risk:
Danish: Disse patienter skal vurderes omhyggeligt før ordination af Spravato, og behandlingen bør kun igangsættes, hvis fordelene opvejer risiciene:
English: The MAH shall ensure that in each MS where SPRAVATO is marketed a CAP is implemented to prevent/minimise the important identified risk of Drug abuse.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at der i hver medlemsstat, hvor Spravato markedsføres, implementeres et program for kontrolleret adgang for at forhindre/minimere den væsentlige identificerede risiko for stofmisbrug.
English: Your doctor will discuss with you whether to stop breast-feeding or stop using this medicine.
Danish: Lægen vil aftale med dig, om du enten skal holde op med at amme eller holde op med at tage lægemidlet.
English: During and after each use of this medicine, your doctor will check your condition and decide how long to monitor you.
Danish: Under og efter hver brug af dette lægemiddel vil din læge kontrollere din tilstand og beslutte, hvor længe du skal holdes under opsyn.
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%).
Danish: De hyppigst observerede bivirkninger hos patienter med behandlingsresistent depression behandlet med Spravato var svimmelhed (30%), kvalme (27%), dissociation (26%), hovedpine (24%), somnolens (18%), vertigo (18%), dysgeusi (17%), hypæstesi (11%), og opkastning (10%).