FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not intended to provide practical advice on how to use Fampyra.
Danish: Det er ikke en praktisk vejledning i, hvordan Fampyra bør anvendes.
English: What are the risks associated with Fampyra?
Danish: Hvilke risici er der forbundet med Fampyra?
English: The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness).
Danish: Bivirkningerne ved Fampyra er hovedsageligt neurologiske (vedrører hjernen eller nerverne) og omfatter krampeanfald, søvnbesvær, angst, balanceproblemer, svimmelhed, usædvanlige prikkende og snurrende fornemmelser (paræstesi), rysten, hovedpine og afkræftelse (asteni).
English: It must not be used in patients who have seizures or have ever had seizures or in patients with kidney problems.
Danish: Det må ikke anvendes til patienter, der lider af krampeanfald eller nogensinde har lidt af krampeanfald, eller patienter med nyreproblemer.
English: A third study in 633 patients measured improvements in walking ability over 24 weeks using a rating scale known as the multiple sclerosis walking scale (MSWS), where patients rated how well they were able to do various activities such as walking, running or climbing stairs.
Danish: I en tredje undersøgelse hos 633 patienter måltes der forbedringer i gangevnen i løbet af 24 uger ved hjælp af en vurderingsskala, der kaldes MSWS (gangskala for multipel sklerose), hvor patienterne vurderede, hvor godt de var i stand til at udføre forskellige aktiviteter såsom gang, løb eller trappegang.
English: Two main studies in 540 patients with multiple sclerosis showed that Fampyra was more effective than placebo (a dummy treatment) at improving walking speed.
Danish: To hovedundersøgelser hos 540 patienter med multipel sklerose viste, at Fampyra var mere effektivt end placebo (en virkningsløs behandling) til at forbedre ganghastigheden.
English: Fampyra must not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2' such as cimetidine.
Danish: Fampyra må ikke anvendes sammen med andre lægemidler, som indeholder fampridin, eller lægemidler, der hæmmer organisk kationtransporter 2 (OCT2), som f.eks. cimetidin.
English: The studies with Fampyra showed that the medicine is likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients.
Danish: Undersøgelserne af Fampyra viste, at lægemidlet sandsynligvis kan gavne ca. en tredjedel af de patienter med MS, som lider af gangbesvær, og at patienter, der har gavn af behandlingen, kan identificeres på et tidligt stadie, så behandlingen kan stoppes hos de øvrige patienter.
English: Fampyra was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Danish: Der blev oprindeligt udstedt en "betinget godkendelse" for Fampyra, fordi der afventedes yderligere dokumentation om lægemidlet.
English: The European Medicines Agency therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Fampyra opvejer risiciene for patienter med gangbesvær, og anbefalede udstedelse af markedsføringstilladelse for Fampyra.
English: It contains the active substance fampridine.
Danish: Lægemidlet indeholder det aktive stof fampridin.
English: The active substance in Fampyra, fampridine, is a potassium channel blocker.
Danish: Det aktive stof i Fampyra, fampridin, blokerer kaliumkanalerne.
English: Fampyra is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.
Danish: Fampyra er et lægemiddel, der anvendes til at forbedre gangevnen hos voksne med multipel sklerose (MS), som lider af gangbesvær.
English: This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.
Danish: Dette menes at have den virkning, at den elektriske impuls fortsat kan bevæge sig langs nerverne for at stimulere musklerne, og det derved bliver lettere at gå.
English: For more information about treatment with Fampyra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Fampyra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells.
Danish: Det virker på de beskadigede nerver, hvor det forhindrer ladede kaliumpartikler i at forlade nervecellerne.
English: In the second study the results were similar, with 43% of patients in the Fampyra group surpassing their previous best speed on three out of four occasions, compared with 9% in the placebo group.
Danish: I den anden undersøgelse var resultaterne tilsvarende, idet 43 % af patienterne i Fampyra-gruppen opnåede en bedre hastighed end deres tidligere bedste hastighed ved tre ud af fire lejligheder, sammenlignet med 9 % i placebogruppen.
English: In MS, this transmission of electrical impulses is impaired when the protective sheaths around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.
Danish: Ved MS hæmmes denne transmission af elektriske impulser, når de beskyttende hinder omkring nerverne bliver beskadiget, og dette kan føre til muskelsvaghed, muskelstivhed og gangbesvær.
English: In one of the studies 35% of patients taking Fampyra had higher walking speed on at least three out of four occasions than their quickest speed before treatment compared with 8% of patients taking placebo .
Danish: I en af undersøgelserne havde 35 % af de patienter, der tog Fampyra, en højere ganghastighed ved mindst tre ud af fire lejligheder end deres hurtigste hastighed inden behandlingen, sammenlignet med 8 % af de patienter, der tog placebo.
English: For the body's muscles to contract, electrical impulses are transmitted along the nerves to the muscles.
Danish: For at kroppens muskler kan trække sig sammen, skal der sendes elektriske impulser til musklerne langs nerverne.
English: MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Danish: MS er en nervesygdom, hvor en betændelsestilstand ødelægger den beskyttende hinde omkring nerverne.
English: For practical information about using Fampyra, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Fampyra, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The medicine can only be obtained with a prescription, and should be prescribed by a doctor experienced in treating MS. For further information, see the package leaflet.
Danish: Lægemidlet udleveres kun efter recept og bør ordineres af en læge med erfaring i behandling af MS.
English: In this study, 43% of patients taking Fampyra had at least an 8-point improvement in their MSWS score compared with 34% of those on placebo.
Danish: I denne undersøgelse opnåede 43 % af de patienter, der tog Fampyra, en forbedring i deres MSWS-score på mindst 8 point, sammenlignet med 34 % af de patienter, der tog placebo.
English: How is Fampyra used?
Danish: Hvordan anvendes Fampyra?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fampyra have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Fampyra.
English: What benefits of Fampyra have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Fampyra?
English: For the full list of all side effects reported with Fampyra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Fampyra fremgår af indlægssedlen.
English: How does Fampyra work?
Danish: Hvordan virker Fampyra?
English: Suspension for injection.
Danish: Suspension til injektion
English: Medicinal product no longer authorised
Danish: Lægemidlet er ikke længere autoriseret til salg
English: Subcutaneous Type I glass bottle with butyl elastomere closure
Danish: Type I glasflaske med butyl elastomerprop
English: Bluetongue Virus Serotype 1 antigen ≥ 8.1 CCID50*
Danish: Bluetonguevirus serotype 1 antigen
English: Packaging Content Package size Withdrawal period
Danish: Indhold Pakningsstørrelse
English: Invented Name
Danish: Særnavn Styrke
English: Strength
Danish: Emballage
English: Pharmaceutical Form
Danish: Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Target species
Danish: Indgivelsesv ej
English: Note:
Danish: Bemærk:
English: Product information
Danish: Produktinformation
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 ajourføres af medlemsstatens kompetente myndigheder, i givet fald i samarbejde med referencemedlemsstaten, i henhold til procedurerne i afsnit III, kapitel 4, i direktiv 2001/83/EF.
English: Annex III Product information
Danish: Bilag III Produktinformation
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Danish: Denne produktinformation er resultatet af den indbringelsesprocedure, som denne afgørelse fra Kommissionen vedrører.
English: The valid product information is the final version achieved during the Coordination group procedure.
Danish: Den gyldige produktinformation er den endelige version, der er udarbejdet under behandlingen i koordinationsgruppen.
English: This summary was last updated in 07-2016.
Danish: Dette sammendrag blev sidst ajourført i 07-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for HyQvia on 16 May 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for HyQvia den 16. maj 2013.
English: The study showed that HyQvia was able to reduce this number to 0.03 per year.
Danish: Undersøgelsen viste, at HyQvia var i stand til at nedsætte dette antal til 0,03 pr. år.
English: This is a summary of the European public assessment report (EPAR) for HyQvia.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for HyQvia.
English: The full EPAR for HyQvia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for HyQvia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This study was extended to almost 4 years and confirmed the long-term benefits and safety of HyQvia.
Danish: Denne undersøgelse blev udvidet til næsten fire år og bekræftede den positive langtidsvirkning og sikkerhed ved HyQvia.
English: IgG has been used as a medicine since the 1950s and has a wide range of activity against organisms that can cause infection.
Danish: IgG har været anvendt som lægemiddel siden 1950'erne og virker bredt mod en række organismer, der kan forårsage infektioner.
English: Why is HyQvia approved?
Danish: Hvorfor er HyQvia blevet godkendt?
English: What is HyQvia and what is it used for?
Danish: Hvad er HyQvia, og hvad anvendes det til?
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Danish: Det indeholder immunglobulin G (IgG), som er en type antistof.
English: Human normal immunoglobulin has been used to treat these diseases for many years.
Danish: Normalt humant immunglobulin har været anvendt til behandling af disse sygdomme i mange år.
English: Other information about HyQvia
Danish: Andre oplysninger om HyQvia
English: What measures are being taken to ensure the safe and effective use of HyQvia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af HyQvia?
English: HyQvia must not be given into a blood vessel or a muscle.
Danish: HyQvia må ikke indgives i et blodkar eller en muskel.
English: The most common side effects with HyQvia (which may affect more than 1 in 10 people) are local reactions such as swelling and discomfort at the site of the infusion.
Danish: De almindeligste bivirkninger af HyQvia (som kan optræde hos flere end 1 ud af 10 personer) er lokale reaktioner såsom hævelse og ubehag på infusionsstedet.
English: The Committee therefore decided that HyQvia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Udvalget afgjorde derfor, at fordelene ved HyQvia overstiger risiciene og anbefalede, at lægemidlet blev godkendt til anvendelse i EU.
English: The possibility of patients or their carers giving the medicine themselves at home may also improve the convenience of the product.
Danish: Muligheden for, at patienten eller dennes omsorgsgiver selv indgiver lægemidlet derhjemme, kan desuden gøre produktet mere bekvemt at anvende.
English: The main measure of effectiveness was the number of serious bacterial infections that developed over one year of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af alvorlige bakterielle infektioner i løbet af et års behandling.
English: Although there had been concerns that antibodies that develop against recombinant hyaluronidase could cause side effects by affecting the natural version of the enzyme, the results of studies were reassuring.
Danish: Selv om der har været betænkelighed ved, at de antistoffer, der udvikles imod rekombinant hyaluronidase, kunne forårsage bivirkninger ved at påvirke den naturlige version af enzymet, har resultaterne været beroligende.
English: • low levels of antibodies in the blood in patients who have chronic lymphocytic leukaemia or myeloma (two cancers affecting different types of white blood cell) and who have frequent infections.
Danish: • lavt indhold af antistoffer i blodet hos patienter, der har kronisk lymfocytær leukæmi eller myelom (to kræfttyper, der udgår fra forskellige typer hvide blodlegemer), og som ofte får infektioner
English: HyQvia is available as two solutions for infusion (drip) under the skin.
Danish: HyQvia fås som to opløsninger til infusion (med drop) under huden.
English: What are the risks associated with HyQvia?
Danish: Hvilke risici er der forbundet med HyQvia?
English: HyQvia is used as ‘replacement therapy' to treat:
Danish: HyQvia anvendes til "erstatningsbehandling" af:
English: The dose and frequency of infusions (how often it is given) depend on the individual patient and may need to be adjusted depending on their response.
Danish: Dosis og hyppighed af infusionerne afhænger af den enkelte patient, og det kan være nødvendigt at ændre doserne, afhængigt af behandlingens virkning.
English: In accordance with current guidelines for these medicines, HyQvia was investigated in one main study lasting over a year and involving 89 patients with PID who had already had treatment with human normal immunoglobulin for at least three months.
Danish: I overensstemmelse med gældende retningslinjer for sådanne lægemidler blev HyQvia undersøgt i én hovedundersøgelse, der varede over et år og omfattede 89 patienter, som havde primære immundefektsyndromer (PID) og i forvejen var blevet behandlet med normalt humant immunglobulin i mindst tre måneder.
English: HyQvia is used in patients with immunodeficiency syndromes.
Danish: HyQvia anvendes til at behandle patienter med immundefektsyndromer.
English: Patients or their carers may be able to give HyQvia themselves once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsgiver har mulighed for selv at give HyQvia efter at have fået tilstrækkelig instruktion.
English: HyQvia can only be obtained with a prescription and treatment should be started and monitored by a doctor or nurse experienced in treating immunodeficiency syndromes.
Danish: HyQvia fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge eller sygeplejerske med erfaring i at behandle immundefektsyndromer.
English: It is not intended to provide practical advice on how to use HyQvia.
Danish: Det er ikke en praktisk vejledning i, hvordan HyQvia bør anvendes.
English: HyQvia also contains recombinant human hyaluronidase.
Danish: HyQvia indeholder desuden rekombinant humant hyaluronidase.
English: For more information about treatment with HyQvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med HyQvia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This was below the predefined number needed to show effectiveness (which is one infection per year), and was similar to that seen with other licensed human normal immunoglobulin products.
Danish: Dette var under det fastlagte maksimale antal til påvisning af effektivitet (som er én infektion årligt) og svarede til virkningen af andre godkendte produkter indeholdende normalt humant immunglobulin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that HyQvia produces a similar reduction in the number of serious bacterial infections to that seen with other immunoglobulin products, and using recombinant hyaluronidase allows subcutaneous infusions to be given at much longer intervals, although local reactions are slightly more common.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konstaterede, at HyQvia giver samme reduktion i antallet af alvorlige bakterielle infektioner som andre immunglobulinprodukter, og at anvendelsen af rekombinant hyaluronidase giver mulighed for meget længere mellemrum mellem infusionerne under huden, dog optræder lokale reaktioner lidt oftere.
English: HyQvia must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or hyaluronidase or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Danish: HyQvia må hverken anvendes hos patienter, der kan være overfølsomme (allergiske) over for normalt humant immunglobulin eller andre af indholdsstofferne, eller hos patienter med allergi over for andre typer immunglobulin, navnlig hvis de har et meget lavt indhold af immunglobulin A (IgA) og danner antistoffer mod IgA.
English: • primary immunodeficiency syndromes (PID, when patients are born with an inability to produce enough antibodies);
Danish: • primære immundefektsyndromer (PID) dvs. medfødt utilstrækkelig evne til at producere antistoffer
English: The active substance in HyQvia, human normal immunoglobulin, is a highly purified protein extracted from the blood.
Danish: Det aktive stof i HyQvia, normalt humant immunglobulin, er et højtrenset protein, der er udvundet af blodet.
English: HyQvia works by restoring abnormally low IgG levels to their normal range in the blood.
Danish: HyQvias virkning består i, at det bringer et unormalt lavt IgG-indhold i blodet tilbage til det normale niveau.
English: The product also contains recombinant human hyaluronidase, which is an enzyme used to help deliver the human normal immunoglobulin under the skin and improve its absorption into the body.
Danish: Produktet indeholder desuden rekombinant humant hyaluronidase, der er et enzym, som har til formål at forbedre tilførslen af normalt humant immunglobulin under huden og øge dets optagelse i kroppen.
English: For practical information about using HyQvia, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af HyQvia, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: When given under the skin before the normal human immunoglobulin, it helps to deliver the active substance under the skin, and assists its absorption into the body.
Danish: Når hyaluronidase gives under huden før det normale humane immunglobulin, øger det tilførslen af det aktive stof til underhuden og medvirker til, at det optages i kroppen.
English: Human normal immunoglobulin
Danish: Normalt humant immunglobulin
English: How is HyQvia used?
Danish: Hvordan anvendes HyQvia?
English: A solution containing recombinant human hyaluronidase is given first and a solution containing human normal immunoglobulin (100 mg/ml) is then given by infusion in the same place.
Danish: Derefter gives på samme sted en infusion af en opløsning af normalt humant immunglobulin (100 mg/ml).
English: HyQvia contains the active substance human normal immunoglobulin.
Danish: Det indeholder det aktive stof normalt humant immunglobulin.
English: What benefits of HyQvia have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved HyQvia?
English: For the full list of all side effects reported with HyQvia, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved HyQvia fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of HyQvia have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af HyQvia.
English: These are patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
Danish: Hos disse patienter indeholder blodet ikke tilstrækkeligt med antistoffer, der også kaldes immunglobuliner.
English: How does HyQvia work?
Danish: Hvordan virker HyQvia?
English: Detailed information about using HyQvia is provided in the package leaflet.
Danish: Indlægssedlen indeholder detaljerede anvisninger for anvendelsen af HyQvia.
English: This is a form of the natural human enzyme, hyaluronidase, which breaks down a substance called hyaluronic acid that is present in the tissues in the tiny spaces between cells and so makes the area between cells temporarily more liquid.
Danish: Denne syre findes i vævene i de små mellemrum mellem cellerne og bevirker, at området mellem cellerne midlertidigt bliver mere flydende.
English: This summary was last updated in 12-2009.
Danish: Dette sammendrag blev sidst ajourført i 12-2009.
English: In addition, the baby must have a normal heart rate.
Danish: Derudover skal barnet have en normal hjerterytme.
English: The main measure of effectiveness was whether the treatment had worked after a week.
Danish: Det primære mål for virkningen var, om behandlingen havde virket efter en uge.
English: The marketing authorisation is valid for an unlimited period.
Danish: Denne markedsføringstilladelse er gyldig på ubegrænset tid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tractocile on 20 January 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tractocile den 20. januar 2000.
English: These signs include:
Danish: Symptomer er følgende:
English: Both contain the active substance atosiban (7.5 mg per millilitre).
Danish: Begge indeholder det aktive stof atosiban (7,5 mg pr. ml).
English: The marketing authorisation holder is Ferring Pharmaceuticals A/S.
Danish: Indehaveren af markedsføringstilladelsen er Ferring Pharmaceuticals A/S.