FrancophonIA/ELRC3.0 huggingface dataset:
English: Through NMDA receptor antagonism, esketamine produces a transient increase in glutamate release leading to increases in α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPAR) stimulation and subsequently to increases in neurotrophic signalling which may contribute to the restoration of synaptic function in these brain regions involved with the regulation of mood and emotional behaviour.
Danish: isoxazolpropionsyrereceptoren (AMPAR) og efterfølgende til stigninger i neurotropisk signalering,hvilket kan bidrage til genoprettelsen af den synaptiske funktion i disse områder af hjernen, der er involveret i reguleringen af humør og emotionel adfærd.
English: Investigations blood pressure increased
Danish: Undersøgelser forhøjet blodtryk
English: ● fast heartbeat
Danish: ● hurtig puls
English: Spravato 84 mg + oral AD
Danish: Spravato 84 mg + oralt AD
English: Spravato dosages were titrated to 56 mg or 84 mg or matching placebo nasal spray administered twice-weekly during a 4-week double-blind induction phase.
Danish: Spravato-doserne blev titreret til 56 mg eller 84 mg eller matchende placebo næsespray administreret to gange om ugen i en 4 uger lang dobbeltblind induktionsfase.
English: In study TRD3002, esketamine plus a newly initiated oral AD demonstrated clinically meaningful and statistical superiority compared to a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Table 5), and symptom reduction was observed as early as 24 hours post-dose.
Danish: I studiet TRD3002 udviste esketamin plus et nyligt initieret oralt AD klinisk relevant og statistisk superioritet sammenlignet med et nyligt initieret oralt AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin) plus placebo næsespray (tabel 5), og der blev observeret symptomreduktion så tidligt som 24 timer efter doseringen.
English: ● itchy nose
Danish: ● kløende næse
English: If any of the above apply to you (or you are not sure), talk to your doctor before using Spravato.
Danish: ● har svære problemer med leveren Tal med lægen, hvis noget af ovenstående passer på dig (eller du er i tvivl), før du bruger Spravato.
English: The potential for overdose of Spravato by the patient is minimised due to the product's design and the administration taking place under the supervision of a healthcare professional (see section 4.2).
Danish: Produktets design, samt det at administrationen finder sted under supervision af en sundhedsperson, minimerer muligheden for, at patienten overdoserer Spravato (se pkt.
English: Nasal sprays
Danish: Næsesprayanordning
English: Dosing frequency
Danish: Bivirkning Hyppighed
English: Pre-treatment of subjects with a history of allergic rhinitis and pre-exposed to grass pollen with oxymetazoline administered as a nasal spray (2 sprays of 0.05% solution administered at 1 hour prior to nasal administration of esketamine) had minor effects on the pharmacokinetics of esketamine.
Danish: Forbehandling med oxymetazolin administreret som næsespray (2 pust med 0,05 % opløsning administreret 1 time forud for administrationen af esketamin) hos forsøgspersoner med allergisk rhinitis i anamnesen, som på forhånd havde været eksponeret for græspollen, havde en mindre effekt på esketamins farmakokinetik.
English: Urinary tract symptoms
Danish: Urinvejssymptomer
English: ● If you have any further questions, ask your doctor or pharmacist.
Danish: ● Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: Patients in stable remission who continued treatment with Spravato plus oral AD experienced a statistically significantly longer time to relapse of depressive symptoms than did patients on a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Figure 1).
Danish: Patienter i stabil remission, som fortsatte behandlingen med Spravato plus oralt AD, oplevede en statistisk signifikant længere tid til tilbagefald af depressive symptomer end de patienter, der var på et nyligt initieret oralt AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin) plus placebo næsespray (figur 1).
English: Spravato 28 mg, 56 mg or 84 mg + oral AD
Danish: Spravato 28 mg, 56 mg eller 84 mg + oralt AD
English: Spravato 28 mg nasal spray, solution esketamine
Danish: Spravato 28 mg næsespray, opløsning esketamin
English: Nasal spray, solution.
Danish: Næsespray, opløsning.
English: About
Danish: Cirka
English: Gastrointestinal disorders nausea, vomiting dry mouth, hypoaesthesia oral salivary hypersecretion
Danish: Mave-tarm-kanalen kvalme opkastning mundtørhed, oral hypæstesi hypersalivation
English: ● panic attacks
Danish: ● panikanfald
English: ● Patients for whom an increase in blood pressure or intracranial pressure poses a serious risk (see section 4.8): Patients with aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels).
Danish: Patienter med aneurismal karsygdom (herunder i interkranielle kar, kar i thorax eller aorta abdominalis eller perifere arterier).
English: In study TRD3001, a clinically meaningful treatment effect in change in MADRS total scores from baseline at the end of the 4-week induction phase was observed favouring Spravato plus newly initiated oral AD compared with a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Table 5).
Danish: I studie TRD3001 blev der observeret en klinisk relevant behandlingseffekt på den samlede MADRS-score fra baseline ved afslutningen af den 4 uger lange induktionsfase til fordel for Spravato plus nyligt initieret oralt AD sammenlignet med et nyligt initieret oralt AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin) plus placebo næsespray (tabel 5).
English: Prepare patient
Danish: Klargøring af patienten
English: Spravato 56 mg + oral AD
Danish: Spravato 56 mg + oralt AD
English: ● One nasal spray device delivers two sprays (one spray per nostril)
Danish: ● Én næsesprayanordning giver to pust (ét pust i hvert næsebor)
English: Starting day 1 dose: 56 mg Subsequent doses: 56 mg or 84 mg twice a week
Danish: 56 m Efterfølgende doser: 56 mg eller 84 mg to gange om ugen
English: Renal and urinary disorders pollakiuria, dysuria, micturition urgency
Danish: Nyrer og urinveje pollaksuri, dysuri, akut vandladningsbehov
English: Talk to your doctor before using Spravato if you have:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du bruger Spravato, hvis du:
English: Sex, n (%)
Danish: Alder, år Median (interval) Køn, n (%) Mand
English: ● change in perception of time
Danish: ● ændret tidsopfattelse
English: Changes in blood pressure
Danish: Blodtryksændringer
English: Spravato 56 mg or 84 mg + oral AD
Danish: Spravato 56 mg eller 84 mg + oralt AD
English: Genotoxicity
Danish: Gentoksicitet
English: Patients with history of intracerebral haemorrhage.
Danish: Patienter, der tidligere har haft hjerneblødning.
English: 28 mg = 1 device
Danish: Anordningen er tom28 mg = 1 anordning
English: If you use more Spravato than you should
Danish: Hvis du har brugt for meget Spravato
English: ● feeling agitated
Danish: ● du føler dig oprevet
English: ● feeling anxious
Danish: ● du føler ængstelse
English: Spravato 28 mg nasal spray, solution
Danish: Spravato 28 mg næsespray, opløsning
English: 28 mg, 56 mg or 84 mg every 2 weeks or once weekly, all dose changes should be in 28 mg increments
Danish: 28 mg, 56 mg eller 84 mg hver anden uge eller én gang ugentligt, alle dosisændringer skal foretages i trin af 28 mg
English: 28 mg, 56 mg or 84 mg once weekly, all dose changes should be in 28 mg increments
Danish: 28 mg, 56 mg eller 84 mg én gang om ugen, alle dosisændringer skal foretages i trin af 28 mg.
English: ● vomiting
Danish: ● opkastning
English: Weeks 1-4: Starting day 1 dose: 28 mg Subsequent doses: 28 mg, 56 mg or 84 mg twice a week, all dose changes should be in 28 mg increments
Danish: 28 mg Efterfølgende doser: 28 mg, 56 mg eller 84 mg to gange om ugen, alle dosisændringer skal foretages i trin af 28 mg
English: How to use Spravato
Danish: Sådan skal du bruge Spravato
English: MIN REST
Danish: MIN HVILEPERIODE
English: Treatment group patients
Danish: § Antal patienter
English: ● urgent need to pass urine
Danish: ● stærk trang til at lade vandet
English: Spravato (28 mg, 56 mg or
Danish: Spravato (28 mg, 56 mg eller 84 mg) + oralt AD
English: What Spravato is and what it is used for What you need to know before you use Spravato How to use Spravato
Danish: Det skal du vide, før du begynder at bruge Spravato Sådan skal du bruge Spravato Bivirkninger
English: In study TRD3005, a clinically meaningful but not statistically significant treatment effect in change in MADRS total scores from baseline at the end of the 4-week induction phase was observed favouring Spravato plus newly initiated oral AD compared with a newly initiated oral AD (SNRI: duloxetine, venlafaxine extended release; SSRI: escitalopram, sertraline) plus placebo nasal spray (Table 5).
Danish: I studie TRD3005 var 64% af de patienter, der var blevet randomiseret til Spravato, ved dag 28 på 84 mg, 25% på 56 mg og 10% på 28 mg. I studiet TRD3005 blev der observeret en klinisk relevant, men ikke statistisk signifikant, behandlingseffekt på den samlede MADRS-score fra baseline ved afslutningen af den 4 uger lange induktionsfase til fordel for Spravato plus nyligt initieret oralt AD sammenlignet med et nyligt initieret oralt AD (SNRI: duloxetin, venlafaxin retard, SSRI: escitalopram, sertralin) plus placebo næsespray (tabel 5).
English: Due to expected increase in exposure and lack of clinical experience, Spravato is not recommended in patients with Child-Pugh class C (severe) hepatic impairment.
Danish: Spravato frarådes til patienter med Child-Pugh klasse C (svær) nedsat leverfunktion på grund af den forventede stigning i eksponeringen og manglende klinisk erfaring.
English: If expired, get a new device.
Danish: Skaf en ny anordning, hvis udløbsdatoen er overskredet.
English: Breast-feeding
Danish: Næsesprays
English: Remission rate
Danish: Leverenzymhæmmere
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten, efter behov, i henhold til de procedurer, der er fastsat i afsnit III, kapitel 4 i direktiv 2001/83/EC.
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Danish: Disse ændringer til de relevante punkter i produktinformationen er resultatet af henvisningsproceduren.
English: ”Inhibitors
Danish: ”Inhibitorer
English: Uncommon (PTPs)* Very common (PUPs)*
Danish: Ikke almindelig (PTPs)* Meget almindelig (PUPs)*
English: If this happens, you should contact your doctor immediately.”
Danish: Kontakt i så fald straks din læge.”
English: Amendments to the product information
Danish: Ændringer til produktinformationen
English: Annex III Amendments to the product information
Danish: Bilag III Ændringer til produktinformationen
English: Of the 22, 10 were high titre (≥ 5 Bethesda Units) and 12 were low titre (< 5 Bethesda Units).
Danish: Af de 22 var 10 høj titer (≥ Bethesda-enheder), og 12 var lav titer (< Bethesda-enheder).
English: The safety and efficacy of {(Invented) name} in previously untreated patients have not yet been established.
Danish: Sikkerhed og virkning af {(særnavn) navn} hos tidligere ubehandlede patienter er endnu ikke klarlagt.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.”
Danish: Behandling af disse patienter bør ledes af en læge med erfaring i behandling af hæmofili og faktor VIII-inhibitorer.”
English: In the PTPT clinical trial (PTP - previously treated patients), none of the 71 subjects developed a de novo FVIII antibody, but 22 of 72 evaluable per protocol PUPs (PUP - previously untreated patients) treated with Recombinate did develop FVIII antibodies and the above frequency was based on the PUP data.
Danish: I de kliniske PTPT-studier (PTP - tidligere behandlede patienter) udviklede ingen af de 71 forsøgspersoner et de novo-FVIII-antistof, men 22 ud af 72 pr. protokol evaluerbare tidligere ubehandlede patienter (PUPs), som blev behandlet med Recombinate, udviklede FVIII-antistoffer, og ovennævnte frekvens var baseret på PUP-data.
English: The reported incidence of inhibitory antibodies in patients with severe haemophilia A who are at high risk for inhibitors development (i.e. previously untreated patients) is estimated in studies to be 31% for Recombinate, which is within the reported range for plasma derived AHF.
Danish: Den rapporterede incidens af inhiberende antistoffer hos patienter med svær hæmofili A, som har høj risiko for udvikling af inhibitorer (dvs. tidligere ubehandlede patienter), estimeres i studier at være 31 % for Recombinate, hvilket ligger inden for det rapporterede interval for plasmaafledt AHF.
English: For all products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Danish: Den eksisterende produktinformation skal ændres for alle produkter anført i Bilag I (indsættelse, erstatning eller sletning af tekst efter behov), så den aftalte ordlyd nedenfor afspejles.
English: If you or your child´s bleeding is not being controlled with <product name>, tell your doctor immediately.”
Danish: Fortæl det straks til lægen, hvis din eller dit barns blødning ikke holdes under kontrol med <produktnavn>.”
English: The risk of developing inhibitors is correlated to the exposure to Antihaemophilic Factor VIII, this risk being highest within the first 20 exposure days.
Danish: Risikoen for at udvikle inhibitorer har sammenhæng med eksponering for antihæmofil faktor VIII, og denne risiko er størst inden for de første 20 eksponeringsdage.
English: >“), all existing information on inhibitor development should be replaced with the following:
Danish: >“), al eksisterende information om udvikling af inhibitorer skal erstattes med følgende:
English: B. Package leaflet [[For all products listed in Annex I] the following texts should be added to or replace existing texts, as appropriate:]
Danish: B. Indlægsseddel ([For alle produkter anført i Bilag I] skal følgende tekst tilføjes eller erstatte eksisterende tekst, efter behov:]
English: Inhibitor Development
Danish: Udvikling af inhibitorer
English: ”Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with <product name> < see section 5.1>.
Danish: ”Der kan udvikles neutraliserende antistoffer (inhibitorer) hos patienter med hæmofili A, som behandles med faktor VIII, herunder med <produktnavn> < se pkt.
English: • For products where a study in PUPs is required but results are not yet available (i.e. products not authorised in PUPs and for which section 4.2 contains the following statement for PUPs (“<Previously untreated patients.
Danish: • For produkter, hvor et studie med tidligere ubehandlede patienter (PUPs) er påkrævet, men resultaterne endnu ikke er tilgængelige (dvs. produkter, der ikke er godkendt til tidligere ubehandlede patienter (PUPs) og hvor pkt.
English: Uncommon (PTPs) *
Danish: Inhibering af faktor VIII Ikke almindelig (PTPs)*
English: • For the remaining products (i.e. products authorised in PUPs), all existing information on inhibitor development should be replaced with the following:
Danish: • For de resterende produkter (dvs. produkter, der er godkendt til tidligere ubehandlede patienter (PUPs)) skal al eksisterende information om udvikling af inhibitorer erstattes med følgende:
English: Section 5.1 - Pharmacodynamic properties (In accordance with the PRAC recommendation, existing relevant text in section 5.1 of the SmPC in relation to inhibitor frequency for Recombinate should be deleted.)
Danish: 5.1 i produktresuméet i forhold til inhibitorfrekvens for Recombinate slettes.)
English: ([For all products listed in Annex I] the wording should be revised as follows: all existing information on inhibitor development should be replaced with the following)
Danish: ([For alle produkter anført i Bilag I] skal ordlyden revideres som følger: al eksisterende information om udvikling af inhibitorer skal erstattes med følgende)
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients”
Danish: • Denne fodnote skal implementeres under tabellen ved brug af akronymet efter behov: *Hyppigheden er baseret på studier med alle FVIII-produkter, som omfattede patienter med svær hæmofili A. PTPs = tidligere behandlede patienter, PUPs = tidligere ubehandlede patienter”
English: ([For all products listed in Annex I] all existing information on inhibitor development should be replaced with the following)
Danish: ([For alle produkter anført i Bilag I] skal al eksisterende information om udvikling af inhibitorer erstattes med følgende)
English: A. Summary of Product Characteristics
Danish: A. Produktresume
English: • [[For products listed in Annex I for which a frequency for PUPs has been implemented in section 4.8 of the SmPC] the wording should be revised as follows:] “For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Danish: ”Hos børn, som ikke tidligere har været i behandling med faktor VIII-lægemidler, er det meget almindeligt (flere end 1 ud af 10 patienter), at der udvikles inhibitor-antistoffer (se punkt 2), mens hos patienter, som tidligere har modtaget behandling med faktor VIII (flere end 150 behandlingsdage), er risikoen ikke almindelig (færre end 1 ud af 100 patienter).
English: (Any reference to inhibitor development studies in PUPs and PTPs in section 4.8 of the SmPC should be deleted.)
Danish: (Enhver henvisning til studier om udvikling af inhibitorer hos tidligere ubehandlede patienter (PUPs) og tidligere behandlede patienter (PTPs) i pkt.
English: [[For all products listed in Annex I] the wording should be revised as follows:] “The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Danish: 2 - Det skal <De> <du> vide, før <De> <du> begynder at <tage> <bruge> {X}: [[For alle produkter anført i Bilag I] skal ordlyden revideres som følger:] “Udvikling af inhibitorer (antistoffer) er en kendt komplikation, som kan opstå under behandling med alle faktor VIII-lægemidler.
English: • [[For products listed in Annex I for which a frequency for PUPs has not been implemented in section 4.8 of the SmPC] the wording should be revised as follows:] “For patients who have received previous treatment with Factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Danish: ”Hos patienter, som tidligere har modtaget behandling med faktor VIII (flere end 150 dages behandling), kan der udvikles inhibitor-antistoffer (se punkt 2) i hyppigheden ikke almindelig (færre end 1 ud af 100 patienter).
English: Section 4.8 - Undesirable effects
Danish: 4.8 i produktresuméet skal slettes.)
English: GR-144 51 Athens Greece
Danish: GR-144 51 Athens
English: B-1800 Vilvoorde
Danish: B-1800 Vilvoorde Belgium
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), ADMINISTRATIONSVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: 6824 DP Arnhem
Danish: 6824 DP Arnhem The Netherlands
English: ANNEX I
Danish: Raapopseweg 1
English: 250mg/5ml amp
Danish: 250 mg/5 ml ampul
English: 50mg/ml amp
Danish: 50 mg/ml ampul
English: 250 mg/5 ml Concentrate for solution for infusion
Danish: 250 mg/5 ml Koncentrat til infusionsvæske, opløsning
English: Netherlands Novartis Pharma B.V. Raapopseweg 1
Danish: Novartis Pharma B.V.
English: The text was valid at that time.
Danish: Teksten var gyldige på det tidspunkt.
English: None required re-start of the medication.
Danish: Ingen krævede genstart af medicineringen.
English: Therefore, this SPC may not necessarily represent the current text.
Danish: Denne tekst repræsenterer derfor ikke nødvendigvis den gældende tekst.
English: In the older age groups no such increase was observed.
Danish: I de ældre aldersgrupper blev der ikke observeret en sådan forøgelse.
English: OVERALL CONCLUSION ON BENEFIT/RISK
Danish: OVERORDNET KONKLUSION VEDRØRENDE BENEFIT/RISK-FORHOLDET
English: Elderly patients may be at an increased risk.
Danish: Ældre patienter kan have øget risiko.
English: • 6-monthly Periodic Safety Update Reports should be provided to the Reference Member States and/or National Competent Authorities for the next 2 years.
Danish: • Periodiske sikkerhedsindberetninger skal hver 6. måned tilsendes referencemedlemsstaterne og/eller de nationale kompetente myndigheder i de næste 2 år.
English: In addition, efficacy could not be demonstrated in this population.
Danish: Desuden kunne der ikke påvises effekt i denne population.
English: Special Populations:
Danish: Særlige populationer:
English: Common: decreased appetite.
Danish: Almindelig: Nedsat appetit.
English: In a majority of instances the complications begin immediately or soon (<24 hours) after delivery.
Danish: I de fleste tilfælde begynder komplikationerne umiddelbart eller hurtigt (<24 timer) efter fødslen.
English: These symptoms may also be due to the underlying disease
Danish: Disse symptomer kan også skyldes den underliggende sygdom.
English: Although all three analyses derived their data from the same database, they differed in a certain extent from each other in terms of design, definitions, specific products that were compared and the time frame within which patients' data was examined.
Danish: På trods af at alle tre analyser hentede deres oplysninger fra den samme database, var de i en vis udstrækning forskellige i udformning, definitioner, specifikke produkter, der blev sammenlignet, og den tidsramme, inden for hvilken patientoplysningerne blev undersøgt.
English: Long-term safety in children
Danish: Langtidssikkerheden hos børn
English: Treatment with paroxetine can be initiated:
Danish: Behandling med paroxetin kan påbegyndes:
English: It is recommended that paroxetine is administered once daily in the morning with food.
Danish: Det anbefales at indtage paroxetin en gang dagligt om morgenen sammen med et måltid.
English: Supportive care with frequent monitoring of vital signs and careful observation is indicated.
Danish: Støttende behandling med hyppig monitorering af vitale tegn og omhyggelig observation er indiceret.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PAROXETINE CONTAINING MEDICINAL PRODUCTS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER, DER INDEHOLDER PAROXETIN (se bilag I)
English: GENERAL INFORMATION
Danish: GENEREL INFORMATION
English: 4.7 Effects on Ability to Drive and Use Machines
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
English: This was supported by a 36 week maintenance study.
Danish: Dette blev understøttet af en 36 ugers ”maintenance study”.
English: No long-term data were submitted.
Danish: Der blev ikke indsendt data fra langtidsstudier.
English: Further to a meeting of the Standing Committee the Commission requested the CHMP to review the new available data.
Danish: Kommissionen anmodede efter et møde i det stående udvalg CHMP om at gennemgå de nye tilgængelige oplysninger.