FrancophonIA/ELRC3.0 huggingface dataset:
English: People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems and stroke.
Danish: Personer med Fabrys sygdom kan have en lang række tegn og symptomer, herunder alvorlige lidelser såsom nyresvigt, hjerteproblemer og slagtilfælde.
English: The active substance in Fabrazyme, agalsidase beta, is a copy of the human enzyme, 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 the enzyme.
Danish: Det aktive stof i Fabrazyme, agalsidase beta, er en kopi af det humane enzym og fremstillet ved hjælp af en metode, der kaldes "rekombinant teknologi": Det fremstilles af celler, som har modtaget et gen (DNA), der sætter dem i stand til at producere enzymet.
English: The effectiveness of Fabrazyme was also tested in 16 children aged between eight and 16 years who had Fabry disease.
Danish: Fabrazymes virkning blev også undersøgt hos 16 børn i alderen otte til 16 år, som havde Fabrys sygdom.
English: The most common side effects with Fabrazyme (seen in more than 1 patient in 10) are caused by the infusion rather than the medicine.
Danish: De hyppigste bivirkninger ved Fabrazyme (som optræder hos flere end 1 ud af 10 patienter) skyldes infusionen snarere end lægemidlet.
English: Enzyme replacement therapies provide patients with the enzyme they are lacking.
Danish: Enzymsubstitutionsbehandlinger giver patienterne det enzym, de mangler.
English: Fabrazyme is intended for long-term use.
Danish: Fabrazyme er beregnet til langvarig brug.
English: In the main study, Fabrazyme was compared with placebo (a dummy treatment) in 58 patients.
Danish: I hovedundersøgelsen blev Fabrazyme sammenlignet med placebo (en virkningsløs behandling) hos 58 patienter.
English: Children treated with Fabrazyme also had decreases in levels of GL-3 in the blood, with all children having normal levels after 20 weeks of treatment.
Danish: Hos børn behandlet med Fabrazyme sås der også et fald i GL-3-niveauet i blodet, mens niveauet hos alle børn var normalt efter 20 ugers behandling.
English: The CHMP decided that Fabrazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Fabrazyme opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (GL-3 or Gb3).
Danish: Patienter med Fabrys sygdom mangler enzymet alfa-galactosidase A. Dette enzym nedbryder normalt et fedtstof, som hedder globotriaosylceramid (GL-3 eller Gb3).
English: Fabrazyme is designed to replace the human enzyme alpha galactosidase A, which is lacking in patients with Fabry disease.
Danish: Fabrazyme er designet til at erstatte det humane enzym alfa-galactosidase A, som patienter med Fabrys sygdom mangler.
English: The CHMP decided that, for patients with Fabry disease, treatment with Fabrazyme might provide longterm clinical benefits.
Danish: CHMP besluttede, at for patienter med Fabrys sygdom kan behandling med Fabrazyme give kliniske fordele på lang sigt.
English: Fabrazyme is a medicine that contains the active substance agalsidase beta.
Danish: Fabrazyme er et lægemiddel, der indeholder det aktive stof agalsidase beta.
English: The replacement enzyme helps to break down GL-3 and stops it building up in the patient's cells.
Danish: Substitutionsenzymet hjælper med at nedbryde GL-3 og forhindrer det i at hobe sig op i patientens celler.
English: If the enzyme is not present, GL-3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Danish: Hvis enzymet mangler, kan GL3 ikke nedbrydes, og det hober sig op i cellerne, f.eks. nyrecellerne.
English: It is available as a powder to be made into a solution for infusion (drip) into a vein.
Danish: Det fås som et pulver, der blandes til en opløsning til infusion (drop) i en vene.
English: Fabrazyme is an enzyme replacement therapy.
Danish: Fabrazyme er en enzymsubstitutionsbehandling.
English: What is the risk associated with Fabrazyme?
Danish: Hvilken risiko er der forbundet med Fabrazyme?
English: Fabrazyme must not be used in people who are hypersensitive (allergic) to agalsidase beta or any of the other ingredients.
Danish: Fabrazyme må ikke gives til personer, der er overfølsomme (allergiske) over for agalsidase beta eller andre af indholdsstofferne.
English: The study looked at the effects of the medicine on clearing GL-3 from the kidney.
Danish: I undersøgelsen blev der set nærmere på lægemidlets virkning med henblik på fjernelse af GL-3 i nyrerne.
English: These include fever, chills, headache, paraesthesia (abnormal sensations like pins and needles), nausea (feeling sick), vomiting and feeling cold. For the full list of all side effects reported with Fabrazyme, see the package leaflet.
Danish: Disse omfatter feber, kulderystelser, hovedpine, paræstesi (unormale fornemmelser såsom prikken og stikken), kvalme, opkastning og kuldefornemmelse.
English: Fabrazyme is used to treat patients who have Fabry disease, a rare inherited disorder.
Danish: Fabrazyme anvendes til behandling af patienter, som lider af Fabrys sygdom, en sjælden arvelig sygdom.
English: Why has Fabrazyme been approved?
Danish: Hvorfor blev Fabrazyme godkendt?
English: What is Fabrazyme?
Danish: Hvad er Fabrazyme?
English: How has Fabrazyme been studied?
Danish: Hvordan blev Fabrazyme undersøgt?
English: What benefit has Fabrazyme shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fabrazyme?
English: What is Fabrazyme used for?
Danish: Hvad anvendes Fabrazyme til?
English: Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Fabrazyme.
Danish: Fabrazyme må kun gives af læger med erfaring i behandling af patienter med Fabrys sygdom eller andre arvelige stofskiftesygdomme.
English: In the main study, Fabrazyme produced a highly significant and almost complete clearance of GL-3 in the kidney cells after 20 weeks of treatment: 69% of the patients treated with Fabrazyme had the best score for clearance, compared with none of the patients in the placebo group.
Danish: 69 % af de patienter, der blev behandlet med Fabrazyme, opnåede de bedste resultater for eliminering, sammenlignet med ingen af patienterne i placebogruppen.
English: How is Fabrazyme used?
Danish: Hvordan anvendes Fabrazyme?
English: How does Fabrazyme work?
Danish: Hvordan virker Fabrazyme?
English: EU/1/12/751/001
Danish: EU/1/12/751/001 Zelboraf
English: Oral use blister (alu/alu) 56 tablets
Danish: Oral anvendelse Blister (alu/alu)
English: Packaging Package size
Danish: Lægemiddelform Indgivelsesvej Emballage Pakningsstørrelse
English: 240 mg Film-coated tablet
Danish: 240 mg
English: This approach is considered acceptable.
Danish: Denne tilgang kan godtages.
English: The treatment can be repeated if required.
Danish: Behandlingen kan gentages efter behov.
English: No evidence of local intolerability was noted.
Danish: Lokal intolerans blev ikke påvist.
English: An allergic reaction can cause any of the following symptoms:
Danish: En allergisk reaktion kan give et af følgende symptomer:
English: Electromyographic guidance is not necessary.
Danish: Elektromyografisk vejledning er ikke nødvendig.
English: o Commitment to alert the National Competent Authorities if there is a significant change in reporting rate.
Danish: o Forpligtelse til at underrette de kompetente nationale myndigheder, hvis der sker væsentlige ændringer i indberetningshyppigheden.
English: b) Distribution of the active substance in patients:
Danish: b) Fordeling af det aktive stof hos patienter:
English: No statistical differences were found between both treatment groups.
Danish: Der blev ikke fundet statistisk forskel mellem de to behandlingsgrupper.
English: In case of an overdose the patient must be monitored medically for several days.
Danish: I tilfælde af overdosering skal patienten være under lægetilsyn i flere dage.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Det gælder også for ukendte eller nytilkomne vira og andre patogener.
English: Your doctor will know if you are at risk.
Danish: Lægen ved, om De er i risikogruppen.
English: Normally, no additional benefit is conferred by treating more frequently than every three months.
Danish: Normalt giver det ingen yderligere fordel at udføre behandlingen hyppigere end hver tredje måned.
English: Against this background a further extensive dose-ranging program would not have been justifiable from an ethical point of view.
Danish: På denne baggrund er et yderligere omfattende dosisfastlæggelsesprogram ikke etisk forsvarligt.
English: Lack of data on repeated administration and the need for data on immunogenicity
Danish: Manglende data om gentagen administration og behovet for data om immunogenicitet
English: Due to the very low number in each group, results of this Phase II study were not considered to be useful from a safety point a view.
Danish: På grund af det meget lille antal i hver gruppe blev resultaterne af denne fase II-undersøgelse ikke anset for at have sikkerhedsmæssig værdi.
English: This list is not exhaustive as any of the muscles responsible for controlling head position may be involved and therefore require treatment.
Danish: Denne liste er ikke udtømmende, da enhver muskel, der medvirker til at kontrollere hovedets stilling, kan være involveret og derfor kræve behandling.
English: If no treatment effect occurs within a month after the initial injection, the following measures should be taken:
Danish: Hvis der ikke opnås behandlingseffekt i løbet af en måned efter den initiale injektion, bør følgende skridt tages:
English: Unopened vial: 3 years
Danish: Uåbnet hætteglas: 3 år
English: Your doctor will then take additional precautions.
Danish: Lægen vil så træffe de nødvendige forholdsregler.
English: During a Scientific Advice procedure in 2000, the EMEA did not require or recommend that further Phase II studies be conducted before the Phase III studies were performed.
Danish: Under en videnskabelig rådgivningsprocedure i 2000 fremsatte EMEA ikke krav eller anbefalinger om, at der skulle udføres yderligere fase II-undersøgelser inden fase III-undersøgelserne.
English: The submitted clinical trial programme consisted of:
Danish: Det forelagte kliniske undersøgelsesprogram bestod af:
English: • non-response/therapy failure during the course of treatment.
Danish: • manglende reaktion/behandlingssvigt under behandlingsforløbet
English: If you have the impression that the effect of Xeomin is too strong or too weak, let your doctor know.
Danish: Hvis De har indtryk af, at virkningen af Xeomin er enten for stærk eller svag, bør De fortælle det til Deres læge.
English: Safety profile
Danish: Sikkerhedsprofil
English: Xeomin should be used with caution:
Danish: Xeomin bør anvendes med forsigtighed:
English: 5.2 Pharmacokinetic properties a) General characteristics of the active substance:
Danish: 5.2 Farmakokinetiske egenskaber a) Generel beskrivelse af det aktive stof:
English: • different treatment intervals
Danish: • forskellige intervaller mellem behandlinger
English: • if you have or have had swallowing difficulties
Danish: • hvis De har eller tidligere har haft synkebesvær
English: The patient should be regarded as a primary non-responder in cases of first injection failure.
Danish: Patienten bør betragtes som en primær ikke-respondent i tilfælde af udeblivende effekt ved den første injektion.
English: Xeomin is used for the treatment of the following conditions in adults:
Danish: Xeomin anvendes til behandling af følgende lidelser hos voksne:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEOMIN <(see Annex I)> - Quality issues
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF XEOMIN (se bilag I) - Spørgsmål vedrørende kvalitet
English: • have had an eye surgery.
Danish: • har fået en øjenoperation.
English: At repeat treatment sessions, the dose may be increased up to two-fold if the response to the initial treatment is considered insufficient - usually defined as an effect that does not last longer than two months.
Danish: Ved gentagne behandlingsforløb kan dosis øges op til det dobbelte, hvis respons på den indledende behandling anses for utilstrækkelig - hvilket sædvanligvis defineres som en virkning af højst to måneders varighed.
English: • injections into another muscle
Danish: • injektionerne gives i en anden muskel
English: The use of Xeomin in children and adolescents has not yet been investigated and is therefore not recommended.
Danish: Brug af Xeomin til børn og unge er endnu ikke undersøgt og må derfor frarådes.
English: The initial dose should not exceed 25 U per eye.
Danish: Initialdosen må ikke overstige 25 E pr. øje.
English: o Steps to be taken to ensure that patients are adequately informed of the safety issues associated with these products, e.g. adequate labelling and patient brochures.
Danish: o Foranstaltninger, der sikrer, at patienterne informeres korrekt om de sikkerhedsmæssige problemer i forbindelse med sådanne produkter, f.eks. passende mærkning og patientinformation.
English: Frequency by different indications
Danish: Hyppighed pr. indikation
English: 4-Aminochinolines may reduce the effect of Xeomin.
Danish: 4-aminoquinoliner kan nedsætte virkningen af Xeomin.
English: The frequency categories are defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000); very rare (<1/10,000).
Danish: Hyppigheden klassificeres som følger: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til < 1/100), sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN [To be completed nationally]
English: Consequently affected persons should avoid these tasks until their faculties are fully recovered.
Danish: Personer, der berøres af dette bør i konsekvens heraf undgå disse aktiviteter, indtil de atter er fuldt funktionsdygtige.
English: Nevertheless the product should be used immediately.
Danish: Medicinen skal dog anvendes med det samme.
English: Based on clinical experience information on the frequency of adverse reactions for the individual indications is given below.
Danish: Baseret på klinisk erfaring gives oplysninger om hyppigheden af bivirkninger for de enkelte indikationer nedenfor.
English: Human pharmacokinetic studies with Xeomin have not been performed for the reasons detailed above.
Danish: Humane farmakokinetiske undersøgelser med Xeomin er ikke udført af de ovenfor angivne grunde.
English: These findings must be interpreted cautiously because all patients were not systematically tested for Botulinum toxin antibodies.
Danish: Disse resultater må fortolkes med forsigtighed, da ikke alle patienter systematisk blev testet for antistoffer mod botulinumtoksin.
English: The recommended single doses of Xeomin should not be exceeded and the intervals between injections should not be shortened.
Danish: De anbefalede enkeltdoser af Xeomin må ikke overskrides, og intervallerne mellem injektioner må ikke afkortes.
English: There are no reports of viral transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Danish: Der foreligger ingen rapporter om overførsel af vira med albumin, der er fremstillet i henhold til Den europæiske Farmakopés specifikationer efter anerkendte processer.
English: This is also relevant for medicinal products that weaken the muscle.
Danish: Det gælder også for lægemidler, der svækker muskulaturen.
English: As with any medicine, an allergic reaction may occur with Xeomin.
Danish: Ligesom med al anden medicin kan der opstå en allergisk reaktion med Xeomin.
English: • To submit the results of a pharmacodynamic study in which “spread” of neurotoxin is quantified in comparison to two other Botox preparations.
Danish: • Forelæggelse af resultaterne af en farmakodynamisk undersøgelse, hvor "spredning" af neurotoxin kvantificeres og sammenlignes med to andre Botox-præparater.
English: Theoretically, the effect of Xeomin may be increased by:
Danish: I teorien kan virkningen af Xeomin blive øget af:
English: • swelling of the hands, feet, ankles, face, lips, mouth or throat.
Danish: • hævelser i hænder, fødder, ankler, ansigt, læber, mund eller hals
English: One hundred and ten patients are in the 3rd and 13 patients in the 4th injection cycle.
Danish: 110 patienter er i det tredje og 13 patienter i det fjerde injektionsforløb.
English: No quality aspects were the subject of disagreement during the Mutual Recognition procedure.
Danish: Under den gensidige anerkendelsesprocedure var der ikke uenighed om kvalitetsmæssige aspekter.
English: The results of initial treatment with Xeomin should be evaluated and may lead to dose adjustment until the desired therapeutic effect is achieved.
Danish: Resultatet af den indledende behandling med Xeomin bør evalueres og kan føre til justering af dosis, indtil den ønskede virkning af behandlingen er opnået.
English: Very common: pain, local weakness
Danish: Meget almindelige: Smerter, lokal svækkelse
English: • Two Phase III studies (one study in each of the intended indication, spasmodic torticollis
Danish: • To fase III-undersøgelser (én for hver af de påtænkte indikationer, henholdsvis torticollis spastica
English: In addition to the list of follow-up measures discussed and requested by the CMDh, the CHMP requested the following follow-up measures to be submitted to the National Competent Authorities and to be assessed under the co-ordination of the RMS:
Danish: Ud over den liste over opfølgende foranstaltninger, der blev drøftet og anmodet af koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer (human), anmodede CHMP om, at nedenstående opfølgende foranstaltninger forelægges de kompetente nationale myndigheder og vurderes med referencemedlemsstaten som koordinerende instans:
English: Xeomin has not been studied in the paediatric population and is therefore not recommended in the paediatric age group until further data become available.
Danish: Xeomin er ikke undersøgt hos den pædiatriske population og bør derfor ikke anvendes til denne aldersgruppe, før der foreligger yderligere data.
English: Reconstitution and dilution should be performed with good practice, particularly with respect to asepsis.
Danish: Rekonstitution og fortynding bør udføres i henhold til god praksis, især med henblik på aseptik.
English: Xeomin contains albumin, a derivative of human blood.
Danish: Xeomin indeholder albumin, som er udvundet af humant blod.
English: Like all medicines, Xeomin can cause side effects, although not everybody gets them.
Danish: Xeomin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Consequently you should avoid driving and operating machinery until your faculties are fully recovered.
Danish: Derfor bør De undlade at køre bil eller betjene maskiner, indtil De har opnået fuld bedring.
English: Presence of infection at the proposed injection site.
Danish: Infektion på det foreslåede injektionssted.
English: The vial must be discarded, if the vacuum does not pull the solvent into the vial.
Danish: Hætteglasset skal kasseres, hvis vakuumet ikke trækker solvensen ind i hætteglasset.
English: • To submit a Risk Management Plan, according to the current guideline, including: o Detailed strategies for educating physicians including appropriate injection techniques, dosing and lack of interchangeability between products as well as programmes for continued and improved monitoring of spread reactions in clinical use and in clinical trials.
Danish: • Forelæggelse af en risikostyringsplan i overensstemmelse med den aktuelle guideline, herunder: o Detaljerede strategier til uddannelse af læger, herunder korrekt injektionsteknik, dosering, produkternes manglende ombyttelighed samt programmer til vedholdende og forbedret overvågning af spredningsreaktioner i klinisk praksis og i kliniske forskningsundersøgelser.
English: An appropriate amount of solvent (see dilution table) is drawn up into a syringe.
Danish: En passende mængde solvens (se fortyndingsskemaet) trækkes op i en sprøjte.
English: If difficulties arise isolating single muscles, injections should be performed using electromyographic guidance.
Danish: Hvis der opstår vanskeligheder med at isolere de enkelte muskler, bør injektionerne udføres under elektromyografisk vejledning.
English: The effect of each treatment generally lasts approximately 3-4 months, however, it may last significantly longer or shorter.
Danish: Generelt varer virkningen af den enkelte behandling i ca. 3-4 måneder, men den kan dog vare betydeligt længere eller kortere.
English: Recovery of impulse transmission is re-established by the formation of new nerve terminals and motor endplates.
Danish: Restitution af impulstransmission opnås ved dannelse af nye nerveterminaler og motoriske endeplader.
English: This may require protective drops, ointments, soft bandage contact lenses, or closure of the eye by patching or similar means.
Danish: Dette kan kræve beskyttende dråber, salver, bløde bandage-kontaktlinser eller tillukning af øjet med klap eller lignende tiltag.
English: o Information on usage patterns and on types of prescribers/users of Xeomin in order to identify if and at what type of clinics off-label cosmetic use is taking place, especially in the EU.
Danish: o Information om anvendelsesmønstre og om typer af ordinerende læger/brugere af Xeomin med henblik på at fastslå, hvorvidt og på hvilken type klinikker produktet anvendes til ikke-godkendte kosmetiske formål, specielt i EU.
English: Recovery after injection normally takes place within 3-4 months as nerve terminals sprout and reconnect with the endplate.
Danish: Regeneration efter injektion finder normalt sted i løbet af 3-4 måneder, når nerveterminalerne kommer frem og igen forbindes med endepladen.
English: • the safety profile of Xeomin in the two Phase III clinical trials based on the documentation submitted by the Marketing Authorisation Holder and the scientific discussion within the Committee,
Danish: • sikkerhedsprofilen af Xeomin i de to kliniske fase III-undersøgelser anbefalede CHMP på grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, og den faglige drøftelse i udvalget udstedelse af markedsføringstilladelse.
English: stiffness, hypertonia
Danish: Stivhed, hypertoni
English: In addition, at present there are three ongoing clinical studies with Xeomin:
Danish: Derudover er tre kliniske undersøgelser med Xeomin i gang:
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include careful selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Standardmetoder til forebyggelse af infektioner, der skyldes brug af lægemidler tilberedt ud fra humant blod eller plasma, omfatter nøje udvælgelse af donorer, screening af enkeltdonationer og plasmapools for specifikke markører for infektion samt inklusion af effektive metoder som led i fremstillingen til inaktivering/fjernelse af virus.
English: • medicinal products that interfere with the transfer of an impulse from a nerve to a muscle, e.g.
Danish: • lægemidler, der påvirker overførsel af impulser fra en nerve til en muskel, f.eks.
English: The Botulinum toxin product should be used under specialist supervision in these patients and should only be used if the benefit of treatment is considered to outweigh the risk.
Danish: Hos disse patienter bør botulinumtoksin-produktet anvendes under tilsyn af en speciallæge, og det må kun anvendes, hvis fordelene ved behandlingen anses for at overstige risikoen.