FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Crysvita work?
Danish: Hvordan virker Crysvita?
English: What benefits of Crysvita have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Crysvita?
English: Crysvita was shown to reduce the severity of bone deformities in the wrist and knee and improve the level of phosphate in the blood of children with X-linked hypophosphataemia in one ongoing study, and further data are awaited.
Danish: Det er i en igangværende undersøgelse påvist, at Crysvita reducerer sværhedsgraden af knogledeformiteter i håndled og knæ, og at det forbedrer fosfatniveauet i blodet hos børn med Xbundet hypofosfatæmi.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: Nationale kompetente myndigheder i medlemsstat(er) eller referencemedlemsstaten(r), hvis relevant, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
English: The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Danish: Indehaverne af markedsføringstilladelserne skal fremlægge overbevisende data til udpegelse af en patientpopulation, hos hvem fordelene ved lægemidlet overstiger de fundne risici.
English: Conditions for lifting the suspension of the marketing authorisation
Danish: Begrundelse for hævelse af suspenderingen af markedsføringstilladelserne
English: Annex IV Conditions for lifting the suspension of the marketing authorisation
Danish: Bilag IV Begrundelse for hævelse af suspenderingen af markedsføringstilladelserne
English: Initiation pack: 28 tablets (7 x 90 mg + 21 x 180 mg)
Danish: 90 mg + 180 mg blister (Aclar/alu) Startpakke: 28 tabletter (7 x 90 mg +
English: Your doctor will assess you carefully.
Danish: Lægen vil vurdere dig nøje.
English: • The active substances are:
Danish: • De aktive indholdsstoffer er:
English: This pack is intended to be used for the first 10 days of treatment.
Danish: Denne pakning er bestemt til anvendelse i de første 10 dage af behandlingen.
English: Only safety data were collected in this study; no new safety signals were identified.
Danish: I undersøgelsen blev der kun indsamlet sikkerhedsdata, og der blev ikke konstateret nye sikkerhedssignaler.
English: An updated RMP should be submitted:
Danish: Der skal indsendes en opdateret RMP:
English: Interaction studies have only been performed in adults.
Danish: Interaktionsundersøgelser er udelukkende foretaget hos voksne.
English: After 4 weeks:
Danish: Efter 4 uger:
English: • you have a tendency to have falls.
Danish: • du har tendens til at falde.
English: Depending on your response to the treatment, your doctor may either decide:
Danish: Afhængigt af din reaktion på behandlingen vil lægen enten beslutte:
English: Start of treatment (first 4 weeks):
Danish: Ved behandlingens start (de første fire uger):
English: Subjects were 25 to 80 years of age with a mean age of approximately 51 years.
Danish: Patienterne var 25-80 år med en gennemsnitsalder på 51 år.
English: Your doctor will discuss with you the risks and benefits of using this medicine in these situations.
Danish: Lægen vil drøfte risici og fordele ved at bruge dette lægemiddel i disse situationer med dig.
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsberetninger
English: • Allergic reactions
Danish: • allergiske reaktioner
English: Please ask your doctor if you are not sure, if any of the above applies to you.
Danish: Spørg lægen, hvis du ikke er sikker på, om nogen af ovenstående punkter gælder for dig.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det giver mulighed for løbende overvågning af lægemidlets benefit/risk-forhold.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Indberetning af formodede bivirkninger efter godkendelse af lægemidlet er vigtig.
English: Other hypersensitivity reactions
Danish: Andre hypersensitivitetsreaktioner
English: Children and adolescents NUEDEXTA should not be used in children and adolescents below the age of 18 years.
Danish: Børn og unge NUEDEXTA bør ikke gives til børn og unge under 18 år.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan desuden indberette bivirkninger direkte gennem det nationale indberetningssystem, der er anført i tillæg V. Ved at indberette bivirkninger kan du medvirke til at skaffe flere oplysninger om sikkerheden af dette lægemiddel.
English: These measures will help protect the environment.
Danish: Derved skåner du miljøet.
English: However, some side effects may be serious and require treatment.
Danish: Nogle bivirkninger kan dog være alvorlige og behandlingskrævende.
English: Furthermore, educational material for HCPs should provide information on the following safety concerns and on the actions needed to reduce the risks:
Danish: Desuden skal uddannelsesmaterialet til det sundhedsfaglige personale indeholde oplysninger om følgende sikkerhedsproblemer og nødvendige tiltag til mindskelse af risiciene:
English: • Pivotal study (07-AVR-123)
Danish: • Hovedundersøgelse (07-AVR-123)
English: Tell your doctor immediately if you notice any of the following:
Danish: Fortæl det straks til lægen, hvis du bemærker noget af det følgende:
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Danish: Før markedsføring i hver medlemsstat skal indehaveren af markedsføringstilladelsen træffe aftale om et uddannelsesprogram med de nationale kompetente myndigheder.
English: Regardless of which strength of NUEDEXTA has been prescribed to you: • continue the treatment with: two capsules per day (one capsule every 12 hours).
Danish: Uanset hvilken styrke af NUEDEXTA, du har fået ordineret: • fortsæt behandlingen med: to kapsler dagligt (én kapsel hver 12. time).
English: This medicine may cause changes in heart rhythm.
Danish: Dette lægemiddel kan medføre ændringer i hjerterytmen.
English: Treatment of overdose
Danish: Behandling af overdosering
English: Each blister is packed in a sleeve.
Danish: Hver blister er pakket i et hylster.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen indsender efterfølgende periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel i overensstemmelse med de krav i listen over EU-referencedatoer (EURD-listen), der er fastsat i artikel 107c (7) i direktiv 2001/83/EC og offentliggjort på den europæiske webportal om lægemidler.
English: Talk to your doctor before and after taking NUEDEXTA if:
Danish: Kontakt lægen, før og efter at du tager NUEDEXTA, hvis:
English: In vitro CYP P450 interaction studies
Danish: In vitro CYP P450-interaktionsundersøgelser
English: • you or a family member currently have or have ever had any heart disease or problems.
Danish: • du eller nogen i familien har eller har haft en hjertesygdom eller hjerteproblemer.
English: A list of all other side effects is provided below:
Danish: Nedenfor er givet en liste over alle andre bivirkninger:
English: The recommended dose titration schedule is outlined below:
Danish: Den anbefalede dosistitreringsplan er angivet nedenfor:
English: The capsules should be taken orally at about the same time each day.
Danish: Kapslerne bør indtages oralt på omtrent samme klokkeslæt hver dag.
English: In addition it shows affinity for the serotonin transporter (SERT) and for the 5-HT1B/D receptor.
Danish: Desuden udviser det affinitet for serotonintransportsystemet (SERT) og for 5-HT1B/D-receptoren.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen indsender den første periodiske opdaterede sikkerhedsindberetning for dette lægemiddel senest 6 måneder efter godkendelsen.
English: Stopping treatment may cause your symptoms to return.
Danish: Ophør med behandlingen kan få symptomerne til at vende tilbage.
English: Clinical studies did not include a sufficient number of patients aged ≥65 years to conclusively determine whether they respond differently in terms of efficacy and safety.
Danish: I de kliniske undersøgelser var der ikke tilstrækkeligt med patienter over 65 år til med sikkerhed at fastslå, om de reagerer forskelligt hvad angår virkning og sikkerhed.
English: • Weeks 2-4 (day 8-28):
Danish: • Uge 2-4 (dag 8-28)
English: If you forget to take 1 or more capsules, you must not take a double dose to make up for the missed doses.
Danish: Hvis du glemmer at tage en eller flere kapsler, må du ikke tage en dobbelt dosis til at erstatte de glemte doser.
English: NMDA receptor antagonists (memantine)
Danish: NMDA-receptorantagonister (memantin)
English: There are no or limited amount of data from the use of NUEDEXTA in pregnant women.
Danish: Der er ingen eller utilstrækkelige data om anvendelse af NUEDEXTA hos gravide kvinder.
English: If this happens to you, do not drive or use machines.
Danish: Hvis dette sker, skal du undgå at føre motorkøretøj og betjene maskiner.
English: • Additional risk minimisation measures
Danish: • Yderligere foranstaltninger til risikominimering
English: Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicine or NUEDEXTA.
Danish: Lægen vil overvåge dig nøje for bivirkninger og/eller muligvis ændre din dosis af det andet lægemiddel eller af NUEDEXTA.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • ved enhver ændring af risikostyringssystemet, navnlig som resultat af, at der tilgår nye oplysninger, som kan medføre væsentlig ændring i benefit/risk-forholdet, eller som følge af, at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: Approximately 74% were Caucasian, 4% were Black, 1% were Asian and 19% were of Hispanic origin.
Danish: Ca. 74 % var af kaukasisk race, 4 % var sorte, 1 % var af asiatisk og 19 % af latinamerikansk oprindelse.
English: • you have had at any time a serious condition called “serotonin syndrome”, which can be caused by certain medicines e.g. antidepressants.
Danish: • du på noget tidspunkt har haft den alvorlige sygdomstilstand “serotoninsyndrom”, der kan fremkaldes af visse lægemidler, f.eks. antidepressiv medicin.
English: No pharmacodynamic interactions were apparent.
Danish: Der blev ikke observeret farmakodynamiske interaktioner.
English: NUEDEXTA is a combination of two active substances:
Danish: NUEDEXTA er et lægemiddel, der indeholder to aktive stoffer:
English: The clinical relevance of this observation to drugs that are OCT1 substrates, such as metformin, is unknown.
Danish: Den kliniske relevans heraf for lægemidler, der er substrater for OCT1, såsom metformin, kendes ikke.
English: Each bottle will be contained within a carton.
Danish: Hver flaske er pakket i en karton.
English: This medicine may cause dizziness and your doctor might need to discuss appropriate precautions to reduce the risk of falls.
Danish: Dette lægemiddel kan medføre svimmelhed, og lægen vil muligvis drøftede passende forholdsregler til mindskelse af risikoen for at falde
English: • if you have a heart problem called “complete heart block” or “long QT syndrome” or have had a problem with your heart called “torsades de pointes”.
Danish: • hvis du har hjerteproblemet “komplet hjerteblok” eller “langt QT-syndrom” eller har haft hjerteproblemet “torsade de pointes”
English: • Off-label use
Danish: • off-label-brug
English: It is very important to tell your doctor if you are taking any of the medicines listed below, as these medicines should never be taken while you are taking NUEDEXTA:
Danish: Det er meget vigtigt, at du fortæller det til lægen, hvis du får nogen af nedenstående lægemidler, da du aldrig må få disse lægemidler, mens du får NUEDEXTA:
English: • Week 1 (day 1-7):
Danish: • Uge 1 (dag 1-7)
English: A review of the patient's current medicines is an essential part of the evaluation of patients for whom treatment with NUEDEXTA is proposed.
Danish: Gennemgang af patientens aktuelle medicin er en essentiel del af evalueringen af patienter, som overvejes sat i behandling med NUEDEXTA.
English: Take your next dose at the usual time and make sure that approximately 12 hours passes between two doses.
Danish: Tag den næste dosis til sædvanlig tid, og sørg for at der går 12 timer mellem to doser.
English: • Studies to Assess Cardiac Effects
Danish: • Undersøgelser til vurdering af kardiale virkninger
English: In case a dose is missed, patients should not take an additional dose, but take the prescribed next dose at the usual time.
Danish: Hvis en dosis glemmes, skal patienten ikke tage en ekstra dosis, men skal tage den efterfølgende ordinerede dosis til sædvanlig tid.
English: These may be a sign of a serious condition called “serotonin syndrome”.
Danish: Dette kan være tegn på den alvorlige tilstand “serotoninsyndrom”.
English: The patient alert card should be provided to all patients with instructions to carry it on them at all times.
Danish: Patientadvarselskort skal udleveres til alle patienter med anvisning om altid at have det på sig.
English: • abnormally frequent daytime urination
Danish: • abnormt hyppig vandladning i dagtiden
English: When the urine pH is less than 7, about 20% of administered quinidine appears unchanged in the urine, but this fraction drops to as little as 5% when the urine is more alkaline.
Danish: Når pH i urinen er under 7, genfindes ca. 20 % af den administrerede kinidin uændret i urinen, men denne andel falder til så lidt som 5 %, når urinen er mere alkalisk.
English: Nuedexta is suitable only for the treatment of PBA, not for other causes of emotional lability.
Danish: NUEDEXTA er udelukkende egnet til behandling af PBA, ikke til andre årsager til emotionel labilitet.
English: Your doctor will decide if you should take this medicine while breast-feeding.
Danish: Lægen vil afgøre, om du skal tage dette lægemiddel, mens du ammer.
English: Treatment of hypotension and of other signs and symptoms should be directed at symptomatic and supportive measures.
Danish: Hypotension og andre tegn og symptomer behandles symptomatisk og støttende.
English: • atomoxetine, used to treat attention-deficit hyperactivity disorder (ADHD)
Danish: • atomoxetin, der anvendes til behandling af hyperaktiv opmærksomhedsforstyrrelse (ADHD)
English: Studies in animals (rats and rabbits) have shown developmental toxicity, including teratogenicity and embryolethality (see section 5.3).
Danish: Undersøgelser i dyr (rotter og kaniner) har vist udviklingstoksicitet, herunder teratogenicitet og embryoletalitet (se pkt.
English: Non-clinical data reveal no special hazard for a genotoxicity or carcinogenic potential, nor for fertility impairment.
Danish: De ikke-kliniske data viser ingen særlig risiko for genotoksicitet, karcinogent potentiale eller nedsættelse af fertiliteten.
English: Caution is required when administering NUEDEXTA in combination with flecainide, chlorpromazine and haloperidol.
Danish: Forsigtighed bør udvises ved administration af NUEDEXTA i kombination med flecainid, chlorpromazin og haloperidol.
English: • excessively slow or shallow breathing (respiratory depression) and/or turning blue.
Danish: • meget langsom eller overfladisk vejrtrækning (respirationsdepression) og/eller blå hud.
English: • For the first seven days of treatment: one capsule per day, taken in the morning.
Danish: • De første 7 dage af behandlingen: en kapsel dagligt om morgenen.
English: • you have a history of drug abuse.
Danish: • du tidligere har haft et stofmisbrug.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter, skal du kontakte lægen, før du tager dette lægemiddel.
English: The most important effects of acute overdoses are ventricular arrhythmias and hypotension.
Danish: De vigtigste bivirkninger af en akut overdosis er ventrikulære arytmier og hypotension.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ\}.
English: Other P-gp substrates for which a dose reduction may be considered include ticagrelor and dabigatran-etexilate.
Danish: Andre P-gp-substrater, for hvilke dosisreduktion kan overvejes, er ticagrelor og dabigatranetexilat.
English: There are several hydroxylated metabolites of quinidine.
Danish: Der findes adskillige hydroxylerede metabolitter af kinidin.
English: In the pre and post-natal developmental study, slight developmental delay was seen in offspring at the mid- and high-doses.
Danish: I den præ- og postnatale udviklingsundersøgelse sås let forsinket udvikling af afkommet i mellemste og højeste dosisgruppe.
English: Renal clearance involves both glomerular filtration and active tubular secretion, moderated by (pH-dependent) tubular reabsorption.
Danish: Den renale clearance omfatter både glomerulær filtration og aktiv tubulær sekretion, modereret af (pH-afhængig) tubulær reabsorption.
English: If you have certain heart problems or are currently taking certain other medicines, NUEDEXTA may not be appropriate for you, or your doctor may want to monitor your heart activity when you start NUEDEXTA.
Danish: Hvis du har visse hjerteproblemer eller får anden medicin, er NUEDEXTA muligvis ikke velegnet til dig, eller lægen vil muligvis overvåge din hjertefunktion, når du påbegynder behandlingen med NUEDEXTA.
English: • you have a condition called myasthenia gravis (an autoimmune neuromuscular disease that causes muscle weakness and fatigability).
Danish: • du har sygdommen myasthenia gravis (en autoimmun neuromuskulær sygdom, der medfører svaghed og udmattelse)
English: Pharmacotherapeutic group: Other nervous system drugs; ATC code: N07XX59
Danish: Farmakoterapeutisk klassifikation: Andre midler med virkning på nervesystemet, ATC-kode: N07XX59
English: Depending on the severity of your problems, your doctor may carefully consider whether this medicine is suitable for you and monitor you more closely for potential side effects.
Danish: Alt efter, hvor svære problemer, du har, vil lægen muligvis nøje overveje, om dette lægemiddel er egnet til dig, og overvåge dig tættere for eventuelle bivirkninger
English: After administration of the combination product, protein binding remains essentially the same as that after administration of the individual components; dextromethorphan is approximately 60-70% protein bound, and quinidine is approximately 80-89% protein bound.
Danish: Efter administration af kombinationsproduktet er proteinbindingen i det væsentlige den samme som efter administration af de enkelte komponenter; dextromethorphan er ca. 60-70 % proteinbundet, og kinidin er ca. 80-89 % proteinbundet.
English: Adverse reactions observed with this medicine may occur more often or may worsen and your doctor may perform some test and monitor you more closely.
Danish: Bivirkningerne med dette lægemiddel kan optræde oftere eller blive forværret, og lægen vil muligvis tage prøver og undersøge dig nærmere.
English: Quinidine clearance is unaffected, although there is an increased volume of distribution that leads to an increase in the elimination half-life.
Danish: Clearance af kinidin påvirkes ikke, skønt der er et forøget fordelingsvolumen, som medfører forlænget eliminationshalveringstid.
English: Lactose warning
Danish: Advarsel om lactose
English: Stop taking NUEDEXTA and seek medical attention immediately if any of the above symptoms occur.
Danish: Hold op med at bruge NUEDEXTA, og søg straks lægehjælp, hvis du får et eller flere af ovennævnte symptomer.
English: If NUEDEXTA and paroxetine are prescribed concomitantly, the initial dose of paroxetine should be reduced.
Danish: Ved samtidig ordination af NUEDEXTA og paroxetin bør initialdosis af paroxetin reduceres.
English: There was no significant difference in the plasma concentrations of dextromethorphan and dextrorphan before and after the administration of memantine, and there was no effect on the plasma concentrations of memantine before and after the administration of dextromethorphan/quinidine.
Danish: Der var ingen nævneværdig forskel i plasmakoncentrationerne af dextromethorphan og dextrorphan før og efter administration af memantin, og der var ingen virkning på plasmakoncentrationen af memantin før og efter administration af dextromethorphan/kinidin.
English: 60% of subjects had underlying ALS and 40% of subjects had underlying MS. All subjects had clinically relevant PBA symptoms, quantified as CNS-LS score of 13 or more.
Danish: 60 % af patienterne havde underliggende ALS, og 40 % havde underliggende MS. Alle havde klinisk relevante symptomer på PBA, der var kvantificeret til en CNS-LS-score på 13 eller derover.
English: Dose increase, if warranted, should be undertaken with caution in these patients.
Danish: Hvis dosisstigning er påkrævet, bør dette ske med forsigtighed hos sådanne patienter.
English: Use in older persons No special dose adjustment of NUEDEXTA is required in older patients.
Danish: Anvendelse hos ældre Der kræves ingen særlig dosistilpasning af NUEDEXTA hos ældre patienter.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, or if you are not using reliable contraception, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, planlægger at blive gravid, eller ikke bruger sikker svangerskabsforebyggelse, skal du spørge lægen til råds, før du bruger dette lægemiddel.
English: • Quinidine increases the amount of dextromethorphan in your body, by blocking the breakdown of dextromethorphan by the liver.
Danish: • Kinidin øger mængden af dextromethorphan i kroppen ved at blokere nedbrydningen af dextromethorphan i leveren.
English: Please tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects.
Danish: Fortæl det til lægen, hvis du får et af følgende lægemidler, da lægen vil overvåge dig nøje for bivirkninger:
English: Paroxetine exposure (AUC0-24) increased by 1.7 fold and Cmax increased by 1.5 fold.
Danish: For paroxetin øgedes eksponeringen (AUC0-24) med en faktor 1,7, og Cmax øgedes med en faktor 1,5.
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis indsendelsen af en PSUR falder sammen med opdateringen af en risikostyringsplan, kan de indsendes samlet.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner bedes indberette alle formodede bivirkninger ved hjælp af de nationale indberetningssystemer, der er anført i Appendiks V .
English: The dose of paroxetine can then be adjusted based on clinical response; however, dosage above 35 mg/day is not recommended.
Danish: Paroxetindosis kan derefter justeres afhængigt af klinisk respons, dog frarådes doser over 35 mg dagligt.
English: Quinidine
Danish: Kinidin
English: Anticholinergic effects of quinidine
Danish: Antikolinerge virkninger af kinidin
English: • excessive muscle stiffness (spasticity)
Danish: • stærk muskelstivhed (spasticitet)
English: • increased liver enzymes (GGT, AST, ALT)
Danish: • forhøjede leverenzymer (GGT, AST, ALT)
English: perphenazine, aripiprazole and chlorpromazine
Danish: perphenazin, aripiprazol og chlorpromazin