FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with BeneFIX, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med BeneFIX, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: BeneFIX is a medicine that contains the active substance nonacog alfa.
Danish: BeneFIX er et lægemiddel, der indeholder det aktive stof nonacog alfa.
English: Other information about BeneFIX
Danish: Andre oplysninger om BeneFIX
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for BeneFIX.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan BeneFIX skal anvendes.
English: Nonacog alfa is not extracted from human blood but produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce human coagulation factor IX.
Danish: Nonacog alfa udvindes ikke af humant blod, men fremstilles ved hjælp af en metode, der kaldes "rekombinant DNA-teknologi", dvs. det fremstilles af celler, der har modtaget et gen (DNA), som sætter dem i stand til at danne human koagulationsfaktor IX.
English: The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs.
Danish: Manglen på faktor IX medfører blodkoaguleringsproblemer såsom blødninger i led, muskler og indre organer.
English: BeneFIX is given by a slow injection into a vein, usually at up to 4 ml per minute and should not be mixed with other infusion solutions or given using a kit other than the one supplied with the medicine.
Danish: BeneFIX indgives ved langsom injektion i en vene, sædvanligvis med op til 4 ml i minuttet, og må ikke blandes med andre opløsninger til injektionsvæske eller indgives med et andet indgivelsessæt end det, der leveres med lægemidlet.
English: Patients or their carers can give injections of BeneFIX, provided that they have been trained appropriately.
Danish: Patienterne eller deres plejere kan godt selv give injektionerne med BeneFIX efter at være blevet instrueret i, hvordan det gøres.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BeneFIX, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for BeneFIX, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: It corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Danish: Det korrigerer faktor IX-manglen og sikrer midlertidig kontrol over blødningsforstyrrelsen.
English: BeneFIX should be started by a doctor who has experience in the treatment of haemophilia.
Danish: Behandling med BeneFIX bør indledes af en læge med erfaring i behandling af hæmofili.
English: The studies assessed the number of bleeding episodes that occurred and rated BeneFIX's effectiveness using a scale from ‘no response' to ‘excellent'.
Danish: Undersøgelserne omfattede en vurdering af forekomsten af blødningsepisoder og målte BeneFIX' virkning ved hjælp af en skala, der gik fra "ingen" til "særdeles god" virkning.
English: BeneFIX is intended for either short-term or long-term use.
Danish: BeneFIX er beregnet enten til kortvarig eller til langvarig behandling.
English: The active substance in BeneFIX, nonacog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot).
Danish: Det aktive stof i BeneFIX, nonacog alfa, er et blodkoagulationsfaktorprotein (et stof, der hjælper blodet med at størkne).
English: If antibodies develop, BeneFIX will not work effectively, which may result in a loss of bleeding control.
Danish: Hvis udvikling af antistoffer forekommer, virker BeneFIX ikke optimalt, og dette kan resultere i manglende kontrol med blødninger.
English: The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery.
Danish: Dosis tilpasses afhængigt af sværhedsgrad og blødningssted eller arten af det kirurgiske indgreb.
English: Full details on how to calculate the dose are included in the summary of product characteristics.
Danish: Nærmere oplysninger om, hvordan dosen beregnes, fremgår af produktresuméet.
English: The dose and the frequency of injection depend on whether BeneFIX is used to treat or prevent bleeding, or to reduce bleeding during surgery, and on the patient's condition.
Danish: Dosis og injektionshyppighed afhænger af, om BeneFIX anvendes til behandling eller forebyggelse af blødning eller til at mindske blødning under et kirurgisk indgreb, og af patientens tilstand.
English: Hypersensitivity (allergic) reactions have been seen in patients treated with products containing factor IX and may sometimes be severe.
Danish: Der kan forekomme overfølsomhedsreaktioner (allergiske reaktioner) hos patienter, der behandles med factor IX-produkter, og disse kan undertiden udvikle sig til svære allergiske reaktioner.
English: BeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder).
Danish: BeneFIX anvendes til behandling og forebyggelse af blødning hos voksne og børn med hæmofili B (medfødte blødningsforstyrrelser).
English: Patients with haemophilia B may also develop neutralising antibodies (inhibitors) to factor IX.
Danish: Patienter med hæmofili B kan også udvikle neutraliserende antistoffer (inhibitorer) over for faktor IX.
English: BeneFIX has been studied in previously treated patients with moderate or severe haemophilia B for prevention or to treat bleeding episodes during and after surgery.
Danish: BeneFIX er blevet undersøgt hos tidligere behandlede patienter med moderat eller svær hæmofili B til forebyggelse eller behandling af blødningsepisoder under og efter kirurgiske indgreb.
English: BeneFIX must not be used in people who are hypersensitive (allergic) to recombinant coagulation factor IX, to any of the other ingredients, or to hamster proteins.
Danish: BeneFIX må ikke anvendes hos personer, der er overfølsomme (allergiske) over for rekombinant koagulationsfaktor IX, over for andre af indholdsstofferne eller over for hamsterproteiner.
English: It is available as a powder and solvent that are mixed together to form a solution for injection.
Danish: Det fås som et pulver og en solvens, som blandes til en injektionsvæske, opløsning.
English: What is the risk associated with BeneFIX?
Danish: Hvilken risiko er der forbundet med BeneFIX?
English: For the full list of all side effects reported with BeneFIX, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved BeneFIX fremgår af indlægssedlen.
English: Patients with haemophilia B lack a protein called factor IX, which is involved in blood clotting.
Danish: Patienter med hæmofili B mangler et protein kaldet faktor IX, som medvirker ved blodets størkning.
English: Why has BeneFIX been approved?
Danish: Hvorfor blev BeneFIX godkendt?
English: How has BeneFIX been studied?
Danish: Hvordan blev BeneFIX undersøgt?
English: What is BeneFIX used for?
Danish: Hvad anvendes BeneFIX til?
English: How is BeneFIX used?
Danish: Hvordan anvendes BeneFIX?
English: What benefit has BeneFIX shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved BeneFIX?
English: What is BeneFIX?
Danish: Hvad er BeneFIX?
English: MA (EU) number
Danish: MA (EU)-nummer
English: 90 (3 x 30) tablets (multipack)
Danish: 100 tabletter 90 (3x30) tabletter (multipak)
English: Pack size
Danish: Pakningsstørr else
English: Route of Administration
Danish: Lægemiddelform Administrationsv ej
English: (Invented) name Strength Pharmaceutical Form
Danish: (Sær)navn
English: This reduces the likelihood of a seizure occurring.
Danish: Dette mindsker sandsynligheden for, at der opstår et anfald.
English: More information about Inovelon is available on EMA's website.
Danish: Der findes yderligere oplysninger om Inovelon på EMA's hjemmeside.
English: What is happening with Inovelon for the treatment of other diseases?
Danish: Hvad sker der med Inovelon til behandling af andre sygdomme?
English: The CHMP considered that the data available at this point in time were not sufficient to recommend this change.
Danish: CHMP var af den opfattelse, at de tilgængelige data på nuværende tidspunkt ikke var tilstrækkelige til at anbefale denne ændring.
English: Inovelon contains the active substance rufinamide and has been authorised since January 2007.
Danish: Inovelon indeholder det aktive stof rufinamid og blev godkendt i januar 2007.
English: What was the conclusion of the CHMP?
Danish: Hvilken konklusion drog CHMP?
English: What was Inovelon expected to be used for?
Danish: Hvad forventedes Inovelon anvendt til?
English: Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Danish: Lennox-Gastaut-syndrom er en af de alvorligste former for epilepsi hos børn.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Inovelon og har behov for mere information om din behandling, kan du kontakte den læge, der står for behandlingen.
English: What are the consequences for patients in clinical trials?
Danish: Hvad er konsekvenserne for patienter, der deltager i kliniske undersøgelser?
English: However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Inovelon's product information.
Danish: Udvalget besluttede dog, at dataene kunne være vigtige for sundhedspersoner, og anbefalede, at de blev indføjet i produktinformationen for Inovelon.
English: It is currently approved only for children aged 4 years or older.
Danish: Det er i øjeblikket kun godkendt til patienter i alderen 4 år og derover.
English: The active substance in Inovelon, rufinamide acts by attaching to special channels on the surface of brain cells (sodium channels), which control their electrical activity.
Danish: Det aktive stof i Inovelon, rufinamid, virker ved at binde sig til nogle bestemte kanaler på overfladen af hjernecellerne (natriumkanaler), der styrer cellernes elektriske aktivitet.
English: The study investigated the safety of Inovelon and also its impact on the child's behavioural and emotional development assessed by the patient's parent or guardian on a standardised scoring system.
Danish: Undersøgelsen omhandlede sikkerheden ved Inovelon og lægemidlets indvirkning på børnenes adfærdsmæssige og følelsesmæssige udvikling bedømt af patientens forældre eller værge ved hjælp af et standardiseret scoresystem.
English: Its signs and symptoms include multiple types of seizures (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Danish: Tegn og symptomer på dette syndrom omfatter forskellige typer anfald, abnorm elektrisk aktivitet i hjernen, indlæringsvanskeligheder og adfærdsproblemer.
English: What is Inovelon?
Danish: Hvad er Inovelon?
English: Inovelon is used for treating Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but can continue into adulthood.
Danish: Inovelon anvendes til behandling af Lennox-Gastauts syndrom, der er en sjælden type epilepsi, som typisk rammer børn, men som kan fortsætte ind i voksenalderen.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of the epilepsy medicine Inovelon to children aged 1 to 4 years.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) har afsluttet gennemgangen af en ansøgning om udvidelse af brugen af epilepsilægemidlet Inovelon til at omfatte børn i alderen 1-4 år.
English: While the study showed that the safety of Inovelon in patients aged 1 to less than 4 years was consistent with the known safety profile in older children, the CHMP concluded that the study was too small to make conclusions on the medicine's effectiveness.
Danish: Selvom undersøgelsen viste, at sikkerheden ved Inovelon hos børn i alderen 1 år til under 4 år var konsistent med den kendte sikkerhedsprofil hos ældre børn, konkluderede CHMP, at undersøgelsen var for lille til, at der kunne drages konklusioner om lægemidlets virkning.
English: The company also proposed a way to make predictions on the use of Inovelon in children aged between 1 and 4 years based on existing data in patients aged 4 years and older.
Danish: Virksomheden foreslog også en måde at forudsige anvendelsen af Inovelon hos børn i alderen 1-4 år på baseret på eksisterende data for patienter i alderen 4 år og derover.
English: The company presented data from a study in which 37 children aged between 1 and 4 years with Lennox-Gastaut syndrome received either Inovelon or another epilepsy medicine in addition to their existing treatment.
Danish: Virksomheden fremlagde data fra en undersøgelse, hvori 37 børn i alderen 1-4 år med LennoxGastauts syndrom fik enten Inovelon eller et andet epilepsimiddel i tillæg til deres eksisterende behandling.
English: There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Inovelon.
Danish: Der er ingen konsekvenser af udfaldet af denne ansøgning for patienter, der deltager i igangværende eller kommende kliniske undersøgelser med Inovelon.
English: There are no consequences on the use of Inovelon in patients with Lennox-Gastaut syndrome aged 4 years and over.
Danish: Der er ingen konsekvenser for brugen af Inovelon hos patienter med Lennox-Gastauts syndrom i alderen 4 år og derover.
English: The CHMP therefore concluded that based on the currently available data, Inovelon could not be approved for patients with Lennox-Gastaut syndrome aged less than 4 years.
Danish: CHMP konkluderede derfor, at Inovelon på grundlag af de aktuelt tilgængelige data ikke kunne godkendes til behandling af patienter med Lennox-Gastauts syndrom på under 4 år.
English: Regarding the data that the company used to make predictions for use in children aged 1 to less than 4 years, the CHMP considered that further analyses were needed in order to make dosing recommendations in the younger age group.
Danish: For så vidt angår de data, som virksomheden anvendte til at forudsige brugen hos børn i alderen 1 år til under 4 år, var CHMP af den opfattelse, at yderligere analyser var påkrævet for at kunne fremsætte doseringsanbefalinger til den yngre aldersgruppe.
English: Further information on the orphan designation can be found here.
Danish: Flere oplysninger om udpegelsen til lægemiddel til sjældne sygdomme findes her.
English: How does Inovelon work?
Danish: Hvordan virker Inovelon?
English: By attaching to these channels, rufinamide prevents them from becoming activated.
Danish: forhindrer rufinamid dem i at blive aktiveret.
English: Inovelon was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 20 October 2004 for Lennox-Gastaut syndrome.
Danish: Inovelon blev den 20. oktober 2004 udpeget som "lægemiddel til sjældne sygdomme" til behandling af Lennox-Gastauts syndrom.
English: However, the CHMP considered that including the data obtained in these children in Inovelon's product information could help the healthcare professionals who manage them.
Danish: CHMP fandt imidlertid, at det kunne være nyttigt at inkludere dataene om disse børn i produktinformationen for Inovelon som hjælp for de sundhedspersoner, der behandler børnene.
English: and prevents abnormal electrical activity from spreading through the brain.
Danish: Dette dæmper hjernecellernes aktivitet og forhindrer abnorm elektrisk aktivitet i at sprede sig i hjernen.
English: The company that markets Inovelon applied for it to be used to treat Lennox-Gastaut syndrome in children aged 1 to 4 years.
Danish: Virksomheden, der markedsfører Inovelon, ansøgte om at få det godkendt til behandling af LennoxGastauts syndrom hos patienter i alderen 1-4 år.
English: This will prevent misuse and help to protect the environment.
Danish: Dette vil forhindre misbrug og hjælpe til at beskytte miljøet.
English: Frequencies are defined as:
Danish: Frekvenserne defineres som:
English: • National specific requirements as agreed with the National Competent Authority regarding:
Danish: • Specifikke nationale krav, som aftalt med den relevante nationale myndighed, vedrørende:
English: It is used when the cancer:
Danish: Det bruges, når kræften:
English: Many of these genes are involved in proliferation, survival, and differentiation.
Danish: Mange af disse gener er involveret i proliferationen, overlevelsen og differentieringen.
English: • Erivedge can be taken with or without food.
Danish: • Erivedge kan tages med eller uden mad.
English: Key data are summarised in Table 2:
Danish: Nøgledata opsummeres i tabel 2.
English: The recommended dose is one capsule each day.
Danish: Den anbefalede dosis er én kapsel hver dag.
English: Treatment interruptions of up to 4 weeks were allowed based on individual tolerability.
Danish: Behandlingsafbrydelser af op til 4 ugers varighed var tilladt baseret på individuel tolerabilitet.
English: The median age for all patients was 72 years.
Danish: Patienternes median alder var 72 år.
English: Talk to your doctor if you wish to have children in the future.
Danish: Tal med lægen, hvis du ønsker at kunne få børn i fremtiden.
English: • Distribution of the product
Danish: • Distribution af produktet
English: Although the number of identified cases is limited, the reactions are serious and the association with vismodegib is plausible.
Danish: Selvom antallet af identicerede tilfælde er begrænset, er reaktionerne alvorlige, og relationen til vismodegib er plausibel.
English: Similar findings were not observed after a 16 week recovery period.
Danish: Der blev ikke observeret lignende fund efter en restitutionsperiode på 16 uger.
English: • A core text as agreed by the Rapporteur
Danish: • Grundtekst, som er godkendt af rapportør
English: Response assessment was based on a composite endpoint defined as above.
Danish: Responsvurdering baseredes på et sammensat endepunkt defineret som ovenfor.
English: Effects on specific enzymes and transporters
Danish: Påvirkning af specifikke enzymer og transportører
English: No correlative histopathologic changes were observed.
Danish: Der blev ikke observeret korrelerede histopatologiske ændringer.
English: The size of the capsule is ‘Size 1' (dimensions 19.0 x 6.6 mm).
Danish: Størrelsen på kapslen er ‘Størrelse 1' (dimension er 19,0 x 6,6 mm).
English: This interaction is not expected to be clinically significant.
Danish: Denne interaktion forventes ikke at være klinisk signifikant.
English: Objective response was defined as a complete or partial response determined on two consecutive assessments separated by at least 4 weeks.
Danish: Objektivt respons blev defineret som fuldstændigt eller delvist respons bestemt ved to på hinanden følgende vurderinger med mindst fire ugers mellemrum.
English: Patients should be instructed never to give this medicinal product to another person.
Danish: Patienterne bør instrueres i, at de aldrig skal give dette lægemiddel til andre.
English: Do not stop taking this medicine without talking to your doctor first as this could make your treatment less effective.
Danish: Du må ikke stoppe med at tage medicinen uden at have snakket med lægen først, da dette kan gøre behandlingen mindre effektiv.
English: Erivedge must not be used during pregnancy.
Danish: Erivedge må ikke anvendes under graviditet.
English: Time to maximum tumour reduction
Danish: Tid til maksimal tumorreduktion
English: You must not become pregnant while taking this medicine.
Danish: Du må ikke blive gravid, mens du tager denne medicin.
English: 3 patients had a best percent change in tumour size of 0; these are represented by minimal positive bars in the figure.
Danish: Tre patienter havde en bedste procentuel ændring i tumorstørrelse på 0; disse repræsenteres ved de mindst positive bjælker i figuren.
English: Pregnancy tests should have a minimum sensitivity of 25 mIU/mL as per local availability.
Danish: Graviditetstesten skal have en minimumsfølsomhed på 25 mIE/ml i overensstemmelse med lokal tilgængelighed.
English: Ex vivo plasma protein binding in human patients is > 99 %.
Danish: Ex vivo-plasmaproteinbinding hos patienter er > 99 %.
English: This damage can change how certain proteins in these cells work and the damaged cells become cancerous and begin to grow and divide.
Danish: Disse skader kan ændre, hvordan bestemte proteiner i disse celler virker, og de beskadigede celler bliver til kræftceller og begynder at vokse og dele sig.
English: Concomitant administration should be performed with caution and a dose adjustment may be necessary.
Danish: Samtidig administration bør foregå med forsigtighed, og dosisjustering kan være nødvendig.
English: In particular, caution should be exercised if vismodegib is administered in combination with any statin.
Danish: Der bør især udvises forsigtighed, hvis vismodegib administreres i kombination med et statin.
English: • every month during treatment.
Danish: • én gang om måneden gennem hele behandlingen.
English: Talk to your doctor if you are not sure.
Danish: Tal med lægen, hvis du er usikker.
English: • Information on the disposal of unwanted medication
Danish: • Information om bortskaffelse af ikke anvendt medicin
English: • has menstruated at any time during the previous 12 consecutive months,
Danish: • har menstrueret på et tidspunkt i de seneste 12 på hinanden følgende måneder
English: Erivedge may affect a woman's ability to have children.
Danish: Erivedge kan påvirke kvinders evne til at få børn.
English: • within a maximum of 7 days before starting treatment - to make sure that you are not already pregnant
Danish: • indenfor maksimum 7 dage inden, behandlingen starter - for at sikre, at du ikke allerede er gravid
English: Please refer to these documents for further information.
Danish: For yderligere oplysninger henvises til disse dokumenter.
English: Date of latest renewal: 26 May 2016
Danish: Dato for første markedsføringstilladelse: 12. juli 2013 Dato for seneste fornyelse: 26. maj 2016
English: You must not become pregnant while taking this medicine (see section 2, “Do not take Erivedge” and “Pregnancy, breast-feeding and fertility”).
Danish: Du må ikke blive gravid, mens du tager denne medicin (se afsnit 2 ”Tag ikke Erivedge” og ”Graviditet, amning og fertilitet”).
English: This may slow down or stop the growth of the cancer cells, or may kill them.
Danish: Medicinen kan nedsætte eller stoppe kræftcellernes vækst eller slå dem ihjel.
English: • Information on the recommended forms of contraception both for women and men
Danish: • Information om de anbefalede præventionsmetoder til både kvinder og mænd
English: Other side effects are presented in order of severity and frequency:
Danish: Andre bivirkninger angives i rækkefølge, ordnet efter sværhedsgrad og hyppighed:
English: • pain (in general) or pain in your arms, legs,
Danish: • smerter (generelt) eller smerter i arme og ben
English: Prescriptions of Erivedge should be limited to 28 days of treatment and continuation of treatment requires a new prescription.
Danish: Ordination af Erivedge bør begrænses til 28 dages behandling, og fortsat behandling bør kræve fornyet ordination.
English: Post-natal development
Danish: Post-natal udvikling
English: • a sexually mature female who
Danish: • en kønsmoden kvinde, der
English: Induction could lead to decreases in systemic exposure of the contraceptive steroids and thereby reduced contraceptive efficacy.
Danish: Induktion kan medføre et fald i den systemiske eksponering af antikonceptive steroider og herved reducere den antikonceptive virkning.