FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Hyperthyroidism that has not been sufficiently treated;
Danish: ● Hyperthyroidisme, som ikke er blevet tilstrækkeligt behandlet.
English: 1,833 adult patients were enrolled, of which 1,601 patients were exposed to Spravato.
Danish: 1.833 voksne patienter blev rekrutteret, hvoraf 1.601 patienter blev eksponeret for Spravato.
English: You might ask them to read this leaflet.
Danish: Du kan også bede dem om at læse denne indlægsseddel.
English: ● Rest in a comfortable position (preferably, semi-reclined) for 5 minutes after each device.
Danish: ● Hvile sig i en komfortabel stilling (helst halvt tilbagelænet) i 5 minutter efter hver anordning.
English: IMPORTANT: Ensure that patient waits 5 minutes after each device to allow medicine to absorb.
Danish: VIGTIGT: Sørg for, at patienten venter 5 minutter efter hver anordning, for at give lægemidlet tid til at absorberes.
English: ● if you recently had a heart attack (within 6 weeks) This is because Spravato can cause a temporary increase in blood pressure that may lead to serious complications in these conditions.
Danish: ● hvis du for nylig har haft et hjerteanfald (inden for 6 uger) Dette er fordi, at Spravato kan medføre en midlertidig stigning i blodtrykket, hvilket kan føre til alvorlige komplikationer af disse medicinske tilstande.
English: Abuse potential
Danish: Potentiale for misbrug
English: The clinical significance of these non-clinical findings in not known.
Danish: Den kliniske signifikans af disse non-kliniske fund er ikke kendt.
English: ● feeling detached from reality
Danish: ● du føler dig løsrevet fra virkeligheden
English: ● feeling extremely happy (“euphoria”)
Danish: ● du føler dig overdrevent glad ("eufori")
English: You may find it helpful to talk to a relative or a close friend if you are depressed and ask them if they think your depression is getting worse or if they are worried about your behaviour.
Danish: Det kan muligvis være en hjælp at tale med et familiemedlem eller en nær ven, hvis du føler dig deprimeret, og spørge dem om de synes, at din depression bliver forværret, eller om de er bekymrede for din adfærd.
English: Dissociation was reported as severe in intensity at the incidence of less than 4% across studies.
Danish: Dissociation blev rapporteret med intensiteten alvorlig i mindre end 4% af tilfældene på tværs af alle studier.
English: In this study, 31.6% of patients received Spravato for greater than 6 months and 7.9% of patients received Spravato for greater than 1 year in the maintenance phase.
Danish: I dette studie fik 31,6% af patienterne Spravato i mere end 6 måneder, og 7,9% af patienterne fik Spravato i mere end 1 år i vedligeholdelsesfasen.
English: Patients on dialysis were not studied.
Danish: Patienter i dialyse er ikke blevet undersøgt.
English: A treatment session consists of nasal administration of Spravato and a post-administration observation period.
Danish: En behandlingssession består af nasal administration af Spravato og en observationsperiode efter administrationen.
English: During the maintenance phase, Spravato dosing should be individualised to the lowest frequency to maintain remission/response.
Danish: Under vedligeholdelsesfasen skal doseringen af Spravato individualiseres til den laveste hyppighed, der kan opretholde remission/respons.
English: Dose adjustments should be made based on efficacy and tolerability to the previous dose.
Danish: Dosisjusteringer bør foretages baseret på virkning og tolerabilitet af den tidligere dosis.
English: Before first device only:
Danish: Kun før første anordning:
English: Instruct the patient to:
Danish: Instruer patienten om at:
English: Exposure in rabbits was in the region of human exposure based on AUC values.
Danish: Eksponeringen hos kaniner lå i området for menneskelig eksponering baseret på AUC-værdier.
English: Spravato is for nasal use only.
Danish: Spravato er kun til nasal anvendelse.
English: This risk persists until significant remission occurs, therefore, patients should be closely monitored.
Danish: Denne risiko varer ved, indtil signifikant remission forekommer og derfor skal patienterne monitoreres nøje.
English: Talk with your doctor about suitable methods of contraception.
Danish: Tal med din læge om egnede præventionsmetoder.
English: This belongs to a group of medicines called anti-depressants and you have been given this medicine to treat your depression.
Danish: Det hører til en gruppe af lægemidler, der kaldes antidepressive lægemidler, og du får dette lægemiddel til behandling af din depression.
English: If not, dispose of device and get a new one.
Danish: Hvis ikke, skal anordningen kasseres og en ny fremskaffes.
English: There are no or limited data on the use of esketamine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data vedrørende anvendelse af esketamin til gravide kvinder.
English: The proportion of the total concentration of esketamine that is bound to proteins in human plasma is on average 43 to 45%.
Danish: Andelen af den totale esketaminkoncentration, som bindes til proteiner i humant plasma, ligger i gennemsnit på 43 til 45%.
English: Your doctor will decide whether you should use this medicine.
Danish: Din læge vil beslutte, om du kan bruge dette lægemiddel.
English: It is given, together with another antidepressant, if you have tried at least 2 other antidepressant medicines but they have not helped.
Danish: Det gives sammen med et andet antidepressivt lægemiddel, hvis du har prøvet mindst 2 andre antidepressive lægemidler, men uden af disse har hjulpet.
English: This is because Spravato has not been studied for treatment-resistant depression in this age group.
Danish: Dette skyldes, at Spravato ikke er blevet undersøgt til behandling af behandlingsresistent depression hos denne aldersgruppe.
English: You should avoid eating for 2 hours before treatment and not drinking liquids for 30 minutes before using this medicine.
Danish: Du bør undgå at spise 2 timer før behandling og ikke drikke væske 30 minutter før, du bruger dette lægemiddel.
English: The guide for patients also aims at increasing awareness about:
Danish: Formålet med vejledningen til patienter er også at øge opmærksomheden omkring:
English: Other CYP enzymes, including CYP2C19 and CYP2C9, contribute to a much smaller extent.
Danish: Andre CYP-enzymer, herunder CYP2C19 og CYP2C9, bidrager i langt mindre udstrækning.
English: To prevent loss of medicinal product, the device should not be primed before use.
Danish: For at undgå tab af lægemiddel skal anordningen ikke præaktiveres før brug.
English: If you use too much Spravato, you are more likely to get side effects (see “Possible side effects”).
Danish: Hvis du bruger for meget Spravato, er det mere sandsynligt, at du får bivirkninger (se "Bivirkninger").
English: ● had a serious head injury or serious problems affecting the brain, particularly where there is increased pressure in the brain
Danish: ● har haft en alvorlig hovedskade eller alvorlige problemer, der påvirker hjernen, især i tilfælde, hvor der er øget tryk i hjernen
English: These effects may impair attention, judgment, thinking, reaction speed and motor skills.
Danish: Disse virkninger kan give nedsat opmærksomhed, dømmekraft, tænkeevne, reaktionshastighed og motoriske evner.
English: ● feeling disconnected from yourself, your thoughts, feelings and things around you
Danish: ● du føler at du ikke er i kontakt med dig selv, dine tanker, følelser og ting omkring dig
English: It is a non-selective, non-competitive, antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.
Danish: Det er en ikke-selektiv, ikke-kompetitiv antagonist mod N-methyl-D-aspartat (NMDA) receptoren, en ionotrop glutamatreceptor.
English: Do not use Spravato if any of the above apply to you.
Danish: Du må ikke bruge Spravato, hvis noget af ovenstående gælder for dig.
English: If your blood pressure goes up after using this medicine and stays high for more than a few hours, you may need to have some more tests.
Danish: Hvis dit blodtryk stiger, efter du har brugt dette lægemiddel, og forbliver højt i mere end et par timer, skal du måske have foretaget flere prøver.
English: Especially tell your doctor if you take:
Danish: Det er især vigtigt, at du fortæller det til din læge, hvis du tager:
English: It is recommended to maintain the dose the patient receives at the end of the induction phase in the maintenance phase.
Danish: Det anbefales at fastholde den dosis, som patienten får ved afslutningen af induktionsfasen, i vedligeholdelsesfasen.
English: Instruct patient to blow nose before first device only.
Danish: Bed patienten om at pudse næse kun før første anordning.
English: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events).
Danish: Depression er forbundet med en forøget risiko for selvmordstanker, skade på sig selv og selvmord (selvmordsrelaterede hændelser).
English: AD = antidepressant; NA = not available
Danish: AD = antidepressivum; IT = ikke tilgængelig
English: ● unusual feeling in the mouth (such as tingling or a crawling feeling)
Danish: ● usædvanlig fornemmelse i munden (såsom en snurrende eller kravlende fornemmelse)
English: Spravato can increase your blood pressure for about 1 to 2 hours after you use it so your blood pressure will be measured before you start using Spravato and after using it.
Danish: Spravato kan øge dit blodtryk i cirka 1 til 2 timer efter at du har brugt det, så dit blodtryk vil blive målt, før du begynder at bruge Spravato, og efter at du har brugt det.
English: Other related terms included derealisation (1.9%), depersonalisation (1.7%), illusions (1.5%), and distortion of time (1.2%).
Danish: Andre relaterede tilstande omfattede derealisation (1,9%), depersonalisation (1,7%), illusioner (1,5%) og forvrænget tidsopfattelse (1,2%).
English: • The procedure for SPRAVATO intranasal administration, including preparation (fasting for 2 hours, no drinking for 30 minutes) and patient's monitoring;
Danish: • Proceduren for intranasal administration af Spravato, herunder forberedelse (faste i 2 timer, ingen væske inden for 30 minutter) og monitorering af patienten.
English: The safety and efficacy of Spravato in paediatric patients aged 17 years and younger have not been established.
Danish: Spravatos sikkerhed og virkning hos pædiatriske patienter i alderen 17 år eller yngre er ikke klarlagt.
English: ● ever had problems with drug abuse - prescribed medicines or illegal drugs - or a problem with alcohol
Danish: ● på et eller andet tidspunkt har haft problemer med stofmisbrug - receptpligtige lægemidler eller illegale stoffer - eller et problem med alkohol
English: In case one or two treatment sessions are missed, the next session should be scheduled when the next session was scheduled to occur based on current treatment frequency.
Danish: I tilfælde af en eller to forpassede behandlingssessioner skal den næste session gennemføres på det tidspunkt, den næste session var planlagt til i henhold til den aktuelle behandlingshyppighed.
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).
Danish: Inden for de anførte systemorganklasser er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Dispose of used device(s) in accordance with local requirements.
Danish: De(n) brugte anordninger(er) skal bortskaffes i overensstemmelse med lokale krav.
English: It is unknown whether esketamine is excreted in human milk.
Danish: Det er uvist, om esketamin udskilles i human mælk.
English: The selection of the newly initiated oral AD was determined by the investigator based on the patient's prior treatment history.
Danish: Valget af det nyligt initierede orale AD blev foretaget af investigator baseret på patientens tidligere behandlingshistorik.
English: Sedation/somnolence
Danish: Sedation/somnolens
English: ● feeling very sleepy with low energy
Danish: ● du føler dig meget søvnig og uden energi
English: The AUC∞ of esketamine was increased by approximately 29%.
Danish: AUC∞ for esketamin blev forhøjet med ca. 29 %.
English: Your doctor or other healthcare professional will show you how to use the nasal spray device (see also Instructions for use).
Danish: Din læge eller en anden sundhedsperson vil vise dig, hvordan du skal bruge næsesprayanordningen (se også Brugsanvisning).
English: Noresketamine is subsequently metabolised via CYP-dependent pathways to other metabolites, some of which undergo glucuronidation.
Danish: Noresketamin metaboliseres efterfølgende via CYP-afhængige veje til andre metabolitter, hvoraf nogle undergår glukuronidering.
English: A similar risk with esketamine cannot be excluded.
Danish: En tilsvarende risiko for esketamin kan ikke udelukkes.
English: Spravato contains esketamine and may be subject to abuse and diversion.
Danish: Spravato indeholder esketamin og kan være genstand for misbrug og diversion.
English: After being treated with this medicine, do not take part in these activities until the next day following a restful sleep.
Danish: Efter behandling med dette lægemiddel, må du ikke udføre sådanne aktiviteter før næste dag, og efter en god nats søvn.
English: ● Check that indicator shows 2 green dots.
Danish: ● Kontrollér, at indikatoren viser 2 grønne prikker.
English: Esketamine is the S-enantiomer of racemic ketamine.
Danish: Esketamin er S-enantiomer af racemisk ketamin.
English: Both parameters were approximately 40% higher in Japanese subjects, relative to Caucasian subjects.
Danish: Begge parametre var cirka 40% højere hos japanske forsøgspersoner i forhold til kaukasisk forsøgspersoner.
English: Gender and body weight
Danish: Køn og legemsvægt
English: ● Repeat Step 4 to deliver second spray.
Danish: ● Gentag trin 4 for at afgive det andet pust.
English: Evidence of therapeutic benefit should be evaluated at the end of induction phase to determine need for continued treatment.
Danish: Evidensen for terapeutiske fordele skal evalueres ved afslutningen af induktionsfasen for at afgøre behovet for fortsat behandling
English: Patients who experience symptoms of a hypertensive crisis should be referred immediately for emergency care.
Danish: Patienter, der oplever tegn på en hypertensiv krise skal øjeblikkeligt henvises til akutbehandling.
English: Tell your doctor if you notice any of the following side effects.
Danish: Fortæl det til lægen, hvis du bemærker en eller flere af følgende bivirkninger.
English: Do not prime or test before use.
Danish: Må ikke præaktiveres eller testes før brug.
English: Your doctor will decide if you need 1, 2 or 3 nasal spray devices and how often you should go to the doctor's office or clinic for the medicine.
Danish: Din læge beslutter, om du har behov for 1, 2 eller 3 næsesprayanordninger, og hvor ofte du skal møde op i lægens konsultation eller på klinikken for at få medicinen.
English: Rates of somnolence were relatively stable over time during long-term treatment.
Danish: Forekomsten af somnolens var relativt stabil over tid under langtidsbehandling.
English: Food and drink
Danish: Mad og drikke
English: Treatment-resistant depression - Long-term studies
Danish: Behandlingsresistant depression - langtidsstudier
English: The primary outcome measure to assess the prevention of depressive relapse was measured as time to relapse.
Danish: Det primære resultatmål til vurdering af forebyggelsen af depressive tilbagefald blev målt som tid til tilbagefald.
English: There is no relevant use of Spravato in children less than 7 years of age in the indication for treatment-resistant depression.
Danish: Det er ikke relevant at anvende Spravato til børn under 7 år til indikationen behandlingsresistent depression.
English: A substantial increase in blood pressure could occur after any treatment session.
Danish: Der kan opstå en betydelig stigning i blodtrykket efter enhver behandlingssession.
English: Pregnancy Do not use Spravato if you are pregnant.
Danish: Graviditet Brug ikke Spravato, hvis du er gravid.
English: ● problems with thinking
Danish: ● problemer med at tænke
English: Spravato can make you feel sleepy, dizzy, and have other side effects that can temporarily affect your ability to drive vehicles or use machines and do activities that need you to be completely alert.
Danish: Spravato kan få dig til at føle dig søvnig, svimmel, og det kan give andre bivirkninger, som midlertidigt kan påvirke din evne til at føre motorkøretøj eller betjene maskiner og udføre aktiviteter, der kræver din fulde opmærksomhed.
English: The recovered radioactivity consisted primarily of esketamine metabolites.
Danish: Den genfundne radioaktivitet bestod primært af esketaminmetabolitter.
English: The maintenance phase was of variable duration and continued until the individual patient had a relapse of depressive symptoms or discontinued for any other reason, or the study ended because the required number of relapse events occurred.
Danish: Vedligeholdelsesfasen var af varierende varighed og fortsatte, indtil den enkelte patient oplevede tilbagefald af depressive symptomer eller standsede behandlingen af andre årsager, eller studiet blev afsluttet, fordi det krævede antal tilbagefaldshændelser blev nået.
English: Depression getting worse
Danish: Forværring af depressionen
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, neurotoxicity, reproductive toxicity, and carcinogenic potential.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser, genotoksicitet, neurotoksicitet, reproduktionstoksicitet og carcinogent potentiale.
English: If your blood pressure is high before using this medicine, your doctor will decide whether to start the medicine or wait until your blood pressure is lower.
Danish: Hvis dit blodtryk er højt, før du bruger dette lægemiddel, vil lægen beslutte, hvorvidt du bør starte behandlingen eller vente, indtil dit blodtryk falder.
English: These adverse reactions were reported as transient and self-limited and occurred on the day of dosing.
Danish: Disse bivirkninger blev rapporteret som forbigående og selvbegrænsede og optrådte på doseringsdagen.
English: Hepatotoxicity has been reported with chronic ketamine use, therefore, the potential for such an effect due to long-term use of Spravato cannot be excluded.
Danish: Der er indberettet hepatotoksicitet ved kronisk brug af ketamin, og risikoen for en sådan virkning efter langvarig brug af Spravato kan derfor ikke udelukkes.
English: Elderly patients treated with Spravato may have a greater risk of falling once mobilised, therefore, these patients should be carefully monitored.
Danish: Ældre patienter, der behandles med Spravato, kan have større risiko for at falde, når de mobiliseres, og disse patienter bør derfor monitoreres nøje.
English: ● Haemodynamically significant valvular heart disease or heart failure (NYHA Class III-IV).
Danish: ● Hæmodynamisk signifikant hjerteklapsygdom eller hjerteinsufficiens (NYHA-klasse III-IV).
English: Elderly (>65 years)
Danish: Ældre (> 65 år)
English: • Due to the potential risk of cardiac adverse events, the patient's blood pressure should be carefully monitored before and after SPRAVATO intake.
Danish: • På grund af den potentielle risiko for kardielle bivirkninger skal patientens blodtryk monitoreres nøje før og efter, at patienten har taget Spravato.
English: However, the maximum dose of 84 mg should be used with caution in patients with moderate hepatic impairment.
Danish: Den maksimale dosis på 84 mg bør dog anvendes med forsigtighed til patienter med moderat nedsat leverfunktion.
English: Adverse reactions reported with esketamine are listed in the table below.
Danish: Bivirkningerne, der er blevet indberettet for esketamin, er anført i tabellen herunder.
English: Sneezing after administration If sneezing occurs immediately after administration, a replacement device should not be used.
Danish: Nysen efter administration Hvis der opstår nysen umiddelbart efter administration, må der ikke anvendes en erstatningsanordning.
English: TRD3005 (≥ 65 years)
Danish: TRD3005 (≥ 65 år)
English: ● Take device from patient.
Danish: ● Tag anordningen fra patienten.
English: Treatment-resistant depression - Short-term studies
Danish: Behandlingsresistent depression - korttidsstudier
English: ● decreased feeling or sensitivity in the mouth
Danish: ● nedsat følelse eller følsomhed i munden
English: This leaflet was last revised in {MM/YYYY} OR {month YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} ELLER {måned ÅÅÅÅ}.
English: The dosing frequency used the majority of the time during the maintenance phase is shown in Table 7.
Danish: Doseringshyppigheden, der blev anvendt størstedelen af tiden under vedligeholdelsesfasen, er vist i tabel 7.
English: If you are able to become pregnant you must use contraception during treatment.
Danish: Hvis du er i stand til at blive gravid, skal du bruge prævention under behandlingen.
English: These can occur with high doses of a similar medicine (called ketamine) used over a long period.
Danish: Sådanne problemer kan forekomme ved brug af høje doser af et lignende lægemiddel (kaldet ketamin) over lang tid.
English: ● Check that indicator shows no green dots.
Danish: ● Kontrollér, at indikatoren ikke viser nogen grønne prikker.
English: Spravato should be used with caution in patients with the following conditions.
Danish: Spravato skal anvendes med forsigtighed hos patienter med følgende sygdomme.
English: Effect of esketamine on other medicinal products
Danish: Esketamins påvirkning af andre lægemidler
English: ● persistent ringing in the ears (tinnitus)
Danish: ● vedvarende ringen for ørerne (tinnitus)
English: ● if you are allergic to esketamine, a similar medicine called ketamine used for anaesthesia, or any of the other ingredients of this medicine (listed in section 6).
Danish: ● hvis du er allergisk over for esketamin, et lignende lægemiddel, der hedder ketamin, som bruges til bedøvelse, eller et af de øvrige indholdsstoffer i Spravato (angivet i afsnit 6).
English: Elderly (65 years of age and older)
Danish: Ældre (65 år og derover)
English: Within each pack, each device is individually packaged in a sealed blister.
Danish: I hver pakning er den enkelte anordning emballeret individuelt i en forseglet blister.
English: Adverse reactions of sedation (9.1%) and somnolence (18.0%) were primarily mild or moderate in severity, occurred on the day of dosing and resolved spontaneously the same day.
Danish: Bivirkninger i form af sedation (9,1%) og somnolens (18,0%) var primært milde eller moderate i sværhedsgrad, de opstod på dagen for doseringen og remitterede spontant samme dag.
English: Post-administration observation
Danish: Observation efter administration
English: Patients who were responders (455), continued receiving treatment with Spravato plus oral AD in a 12-week optimisation phase.
Danish: De patienter, som responderede (455), fortsatte behandlingen med Spravato plus oralt AD i en 12 uger lang optimeringsfase.
English: ● After this, Spravato is usually used either once a week or once every 2 weeks.
Danish: ● Herefter bruges Spravato normalt enten én gang ugentligt eller én gang hver anden uge.
English: Respiratory depression may occur at high doses following rapid intravenous injection of esketamine or ketamine when used for anaesthesia.
Danish: Der kan forekomme respirationsdepression efter hurtig intravenøs injektion af høje doser esketamin eller ketamin, når disse anvendes til anæstesi.
English: Enrollment in TRD3003 was staggered over approximately 2 years.
Danish: Rekrutteringen til TRD3003 strakte sig over cirka 2 år.