FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Febuxostat Mylan has been shown to have comparable quality and to be bioequivalent to Adenuric.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Febuxostat Mylan er af sammenlignelig kvalitet og er bioækvivalent med Adenuric.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Adenuric, and do not need to be repeated for Febuxostat Mylan.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Adenuric, og det er ikke nødvendigt at gentage disse med Febuxostat Mylan.
English: When this happens in the joints and causes pain, it is known as ‘gout'.
Danish: Når det sker i leddene og forårsager smerter, kaldes det "podagra" eller "urinsyregigtanfald".
English: This can reduce the symptoms of gout.
Danish: Dette kan reducere symptomerne på urinsyregigtanfald.
English: This means that Febuxostat Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Adenuric.
Danish: Det betyder, at Febuxostat Mylan indeholder det samme aktive stof og har samme virkning som "referencelægemidlet" Adenuric, som allerede er godkendt i Den Europæiske Union (EU).
English: Febuxostat Mylan should be started 2 days before chemotherapy and continued for at least 7 days.
Danish: Behandlingen med Febuxostat Mylan bør påbegyndes to dage inden kemobehandling og fortsættes i mindst syv dage.
English: Febuxostat Mylan is available as tablets (80 and 120 mg) and can only be obtained with a prescription.
Danish: Febuxostat Mylan fås som tabletter (80 og 120 mg) og udleveres kun efter recept.
English: It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Danish: Det virker ved at blokere et enzym kaldet "xanthinoxidase", som er nødvendigt for, at kroppen kan producere urinsyre.
English: Because Febuxostat Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Febuxostat Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What measures are being taken to ensure the safe and effective use of Febuxostat Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Febuxostat Mylan?
English: In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.
Danish: Hos patienter i kemobehandling forventes en reduktion af urinsyreniveauet at mindske risikoen for tumorlysesyndrom.
English: What is Febuxostat Mylan and what is it used for?
Danish: Hvad er Febuxostat Mylan, og hvad anvendes det til?
English: Therefore, the CHMP's view was that, as for Adenuric, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Adenuric.
English: For more information about treatment with Febuxostat Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Febuxostat Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the benefits and risks of Febuxostat Mylan?
Danish: Hvilke fordele og risici er der forbundet med Febuxostat Mylan?
English: By reducing the production of uric acid, Febuxostat Mylan can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Danish: Ved at reducere produktionen af urinsyre kan Febuxostat Mylan reducere niveauet af urinsyre i blodet og holde det lavt og derved standse opbygningen af krystaller.
English: It is not intended to provide practical advice on how to use Febuxostat Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Febuxostat Mylan bør anvendes.
English: For the treatment of long-term hyperuricaemia, the recommended dose of Febuxostat Mylan is 80 mg once a day.
Danish: Ved behandling af langvarig urinsyregigt er den anbefalede Febuxostat Mylan-dosis 80 mg én gang dagligt.
English: Febuxostat Mylan is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Danish: Febuxostat Mylan anvendes til patienter, som har symptomer på opbygning af krystaller, herunder urinsyregigt (smerter og inflammation i leddene) eller tophi ("sten", større aflejringer af uratkrystaller, som kan medføre led- og knogleskader).
English: Febuxostat Mylan is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Danish: Febuxostat Mylan er et lægemiddel, der anvendes til behandling af voksne med langvarig urinsyregigt (et højt indhold af urinsyre eller "urat" i blodet).
English: Febuxostat Mylan treatment should not be stopped if an attack of gout occurs.
Danish: Behandlingen med Febuxostat Mylan skal ikke ophøre, hvis der kommer et urinsyregigtanfald.
English: Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Febuxostat Mylan.
Danish: Derfor anbefales det, at patienter tager andre lægemidler for at forebygge anfald af urinsyregigt i de første seks måneder af behandlingen med Febuxostat Mylan.
English: Other information about Febuxostat Mylan
Danish: Andre oplysninger om Febuxostat Mylan
English: Febuxostat Mylan is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Danish: Febuxostat Mylan anvendes også til behandling og forebyggelse af et højt indhold af urinsyre i blodet hos voksne med blodkræft, der er i kemobehandling (lægemidler til behandling af kræft), og som er i risikogruppen for at udvikle tumorlysesyndrom (en komplikation som følge af nedbrydningen af kræftceller, der skaber en pludselig forhøjelse af urinsyreindholdet i blodet, som kan beskadige nyrerne).
English: Keeping uric acid levels low for long enough can also shrink tophi.
Danish: Når urinsyreniveauet holdes lavt længe nok, kan det også få de dannede tophi til at svinde ind.
English: Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys.
Danish: Urinsyregigt kan medføre, at der dannes og opbygges uratkrystaller i leddene og nyrerne.
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day.
Danish: Den anbefalede dosis til forebyggelse og behandling af urinsyregigt hos patienter i kemoterapi er 120 mg én gang dagligt.
English: For practical information about using Febuxostat Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Febuxostat Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Febuxostat Mylan, febuxostat, reduces the formation of uric acid.
Danish: Det aktive stof i Febuxostat Mylan, febuxostat, reducerer dannelsen af urinsyre.
English: Febuxostat Mylan febuxostat
Danish: Febuxostat Mylan
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Febuxostat Mylan 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 Febuxostat Mylan.
English: Why is Febuxostat Mylan approved?
Danish: Hvorfor blev Febuxostat Mylan godkendt?
English: Febuxostat Mylan contains the active substance febuxostat and is a ‘generic medicine'.
Danish: Febuxostat Mylan er et "generisk lægemiddel".
English: How is Febuxostat Mylan used?
Danish: Hvordan anvendes Febuxostat Mylan?
English: How has Febuxostat Mylan been studied?
Danish: Hvordan blev Febuxostat Mylan undersøgt?
English: The full EPAR for Febuxostat Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Febuxostat Mylan findes på agenturets websted under: .
English: How does Febuxostat Mylan work?
Danish: Hvordan virker Febuxostat Mylan?
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Indgivelsesvej Indre emballage
English: MA (EU) number (Invented) name
Danish: Markedsføringstilla delsesnummer (EU)
English: The procedure should be carried out under sterile conditions.
Danish: Proceduren skal udføres under sterile forhold.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jetrea on 13 March 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Jetrea den 13. marts 2013.
English: The full EPAR for Jetrea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Jetrea findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Jetrea.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Jetrea.
English: The other eye should not be treated with Jetrea for at least 7 days.
Danish: Det andet øje bør ikke behandles med Jetrea, før der er gået mindst syv dage.
English: Other information about Jetrea
Danish: Andre oplysninger om Jetrea
English: After 28 days, the results were that adhesions had cleared in 25% and 28% of patients who were given Jetrea injection (61 out of 219 and 62 out of 245), compared with 13% and 6% of those who received placebo (14 out of 107 and 5 out of 81).
Danish: Efter 28 dage var vedhæftningen ophævet hos 25 % og 28 % af de patienter, der fik en injektion af Jetrea (61 ud af 219 og 62 ud af 245), sammenholdt med 13 % og 6 % af dem, der fik placebo (14 ud af 107 og 5 ud af 81).
English: What measures are being taken to ensure the safe and effective use of Jetrea?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jetrea?
English: It contains the active substance ocriplasmin.
Danish: Det indeholder det aktive stof ocriplasmin.
English: Jetrea must not be used in patients who have or are thought to have infections in or around the eyes.
Danish: Jetrea må ikke anvendes til patienter, som har eller formodes at have infektioner i eller omkring øjnene.
English: The recommended dose is 0.125 mg given as a single injection into the affected eye which should not be repeated.
Danish: Den anbefalede dosis er 0,125 mg, der gives som en enkelt injektion i det pågældende øje og ikke bør gentages.
English: Why is Jetrea approved?
Danish: Hvorfor blev Jetrea godkendt?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Jetrea outweigh its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Jetrea opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Jetrea and what is it used for?
Danish: Hvad er Jetrea, og hvad anvendes det til?
English: Although the effects shown were modest (resolution of vitreomacular adhesion in a quarter of patients), they were considered to be significant as treatment may improve vision and prevent the need for surgery.
Danish: Selv om virkningerne var beskedne (vitreomakulær adhæsion svandt hos en fjerdedel af patienterne), blev de anset for betydelige, fordi behandlingen kan forbedre synet og give mulighed for at undgå operation.
English: It is not intended to provide practical advice on how to use Jetrea.
Danish: Det er ikke en praktisk vejledning i, hvordan Jetrea bør anvendes.
English: What are the risks associated with Jetrea?
Danish: Hvilke risici er der forbundet med Jetrea?
English: Regarding its safety, the most common side effects were short-lived and considered manageable, and often occurred as a response to the injection procedure or were linked to the resolution of the disease itself.
Danish: Hvad sikkerheden angår, var størstedelen af bivirkningerne kortvarige og kunne behandles, og de skyldtes ofte injektionsproceduren eller var forbundet med helbredelsen af sygdommen i sig selv.
English: In two main studies involving 652 adults with vitreomacular adhesion and decreased vision, patients were given a single intravitreal injection of 0.125 mg Jetrea or a placebo injection (a dummy treatment).
Danish: I to hovedundersøgelser med 652 voksne med vitreomakulær adhæsion og synsnedsættelse fik patienterne enten en enkelt intravitreal injektion på 0,125 mg Jetrea eller en placeboinjektion (en virkningsløs behandling).
English: The company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive the summary of product characteristics for the medicine as well as an information pack to be given to patients.
Danish: Den virksomhed, der fremstiller Jetrea, sørger for, at alle sundhedspersoner, der forventes at anvende Jetrea, modtager produktresuméet for lægemidlet samt en informationspakke, der skal udleveres til patienter.
English: The ophthalmologist may prescribe antibiotic eye drops before and after treatment with Jetrea to prevent eye infections.
Danish: Øjenlægen kan ordinere antibiotiske øjendråber før og efter behandlingen med Jetrea for at forebygge øjeninfektioner.
English: The most common side effects are vitreous floaters (small, often irregular, dark shapes in the field of vision), eye pain, photopsia (flashes of light in the field of vision) and chromatopsia (changes in colour perception), as well as conjunctival haemorrhage (bleeding of the membrane that lies over the white part of the eye).
Danish: De hyppigste bivirkninger er flydere i glaslegemet (små, ofte uregelmæssige, mørke former i synsfeltet), øjensmerter, fotopsi (opfattelse af lysglimt i synsfeltet) og kromatopsi (ændret farveopfattelse) samt konjunktival blødning (blødning i den hinde, der dækker den hvide del af øjet).
English: Jetrea is a solution for injection into the eye.
Danish: Jetrea er en opløsning til injektion i øjet.
English: For more information about treatment with Jetrea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Jetrea, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Jetrea is a medicine used to treat adults with vitreomacular traction, an eye disease that can cause severe visual disturbance.
Danish: Jetrea er et lægemiddel, der anvendes til behandling af voksne med vitreomakulær traktion, som en øjensygdom, der kan give svære synsforstyrrelser.
English: The side effects seen with Jetrea affect the eye.
Danish: Bivirkningerne ved Jetrea påvirker øjet.
English: It can only be obtained with a prescription and must be given by a qualified ophthalmologist (eye specialist) experienced in intravitreal injections (injections into the vitreous humour, the jelly-like material at the back of the eye).
Danish: Det udleveres kun efter recept og skal indgives af en oftalmolog (øjenlæge) med erfaring i intravitreale injektioner (injektioner i øjets glaslegeme, det geléagtige materiale bagest i øjet).
English: The risk of more serious side effects such as decreased vision that is non-reversible, other changes to the retinal function or supporting structures of the lens appear to be small.
Danish: Der synes kun at være lille risiko for mere alvorligere bivirkninger, såsom permanent synsnedsættelse, andre ændringer af nethindens funktion eller af linsens støttestrukturer.
English: Successful treatment of vitreomacular adhesion can help reverse disturbances of the vision caused by vitreomacular traction, and prevent further loss of vision from untreated and progressive traction at the retina.
Danish: En vellykket behandling af vitreomakulær adhæsion kan modvirke synsforstyrrelser fremkaldt af vitreomakulær traktion og forebygge et yderligere synstab som følge af en ubehandlet og gradvist stigende trækbelastning i nethinden.
English: For practical information about using Jetrea, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Jetrea, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Jetrea, ocriplasmin, is similar to human plasmin, a naturally occurring enzyme in the eye which is capable of breaking down proteins between the vitreous humour and the retina which are responsible for the adhesion, thereby reducing retinal swelling and improving vision.
Danish: Det aktive stof i Jetrea, ocriplasmin, svarer til det naturlige enzym plasmin i øjet, som er i stand til at nedbryde de proteiner mellem glaslegemet og nethinden, der forårsager vedhæftningen.
English: How is Jetrea used?
Danish: Hvordan anvendes Jetrea?
English: Vitreomacular traction is caused by vitreomacular adhesion in which the vitreous humour has an abnormally strong attachment to the central part of the retina (the light sensitive membrane at the back of the eye).
Danish: Vitreomakulær traktion skyldes vitreomakulær adhæsion, dvs. unormalt stærk vedhæftning af glaslegemet til den centrale del af nethinden (den lysfølsomme hinde på øjets bagvæg).
English: For the full list of all side effects reported with Jetrea, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Jetrea fremgår af indlægssedlen.
English: Jetrea has been shown in studies to be effective in resolving the adhesion between the vitreous humour and the retina, reducing the need for surgery.
Danish: Undersøgelserne har vist, at Jetrea effektivt ophæver vedhæftningen mellem glaslegemet og nethinden, så behovet for operation nedsættes.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jetrea have also 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 Jetrea.
English: What benefits of Jetrea have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Jetrea?
English: How does Jetrea work?
Danish: Hvordan virker Jetrea?
English: Studies have shown that Jetrea was effective in treating vitreomacular adhesion and it is therefore expected to be effective in preventing worsening of vision which may occur with untreated and progressive vitreomacular traction.
Danish: Det forventes derfor at være effektivt til at forebygge den forværring af synet, der kan forekomme ved ubehandlet fremadskridende vitreomakulær traktion.
English: When the vitreous humour shrinks with aging, this strong attachment results in a pulling force on the retina, which causes retinal swelling and leads to blurred or distorted vision.
Danish: Når glaslegemet skrumper ind med alderen, bevirker den stærke vedhæftning, at nethinden udsættes for en trækbelastning.
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Danish: Bilag I Listen over lægemidlernes navne, lægemiddelform(er), styrke(r), administrationsvej(E), indehavere af markedsføringstilladelse(r) i medlemsstaterne
English: Member State (in EEA)
Danish: Medlemsstater (EØS)
English: 0.10 g/1 g per 100 ml oral solution
Danish: 0.10 g/1 g af 100 ml oral opløsning oral
English: 4 mg/40 mg tablet
Danish: 4 mg/40 mg tablet oral
English: VASOBRAL, solution buvable en flacon
Danish: VASOBRAL, peroral opløsning i hætteglas
English: VASOBRAL, comprimé sécable
Danish: VASOBRAL, tablet med delekærv
English: Marketing Authorisaton Holder
Danish: Indehaveren af tilladelsen til markedsføring handelsnavn dosering formulering indgivelsesmåde
English: The Committee also noted that the last study performed in infants below one year was completed in 2001.
Danish: Udvalget konstaterede desuden, at den sidste undersøgelse, der blev udført hos spædbørn på under et år, blev afsluttet 2001.
English: There is no evidence that either short or long term protection has been impacted.
Danish: Der er hverken vidnesbyrd om, at korttids- eller langtidsbeskyttelsen er forringet.
English: DISCUSSION
Danish: DISKUSSION
English: It was considered that a decision will be taken according to the responses given on quality and clinical concerns.
Danish: En afgørelse forventedes at ville blive truffet i henhold til de besvarelser, der gives på spørgsmålene vedrørende kvalitet og kliniske egenskaber.
English: These changes, in principle, address the concerns raised by the CHMP and its Working Parties.
Danish: Disse ændringer imødekommer i princippet de betænkeligheder, der er rejst af CHMP og dettes arbejdsgrupper.
English: The reason for decreasing immunogenicity over several years remains still unidentified.
Danish: Årsagen til den gennem flere år aftagende immunogenicitet er fortsat ukendt.
English: Information will be provided to health care professionals and will ensure that the vaccine will be correctly used in the different age and risk categories.
Danish: Oplysningerne vil blive formidlet til sundhedspersoner og vil sikre, at vaccinen anvendes korrekt hos de forskellige alders- og risikogrupper.
English: have been assessed and extensively discussed by the CHMP and its Working Parties (Biotechnology Working Party, Vaccines Working Party).
Danish: er blevet gennemgået og tilbundsgående drøftet af CHMP og dettes arbejdsgrupper (arbejdsgruppen vedrørende bioteknologi og arbejdsgruppen vedrørende vacciner).
English: Potential remaining risks will be minimised to an acceptable level by the fundamentally revised SPC.
Danish: De tilbageværende potentielle risici vil blive minimeret til et acceptabelt niveau ved det gennemreviderede produktresumé.
English: The CHMP endorsed the new product information and agreed to finalise the article 20 procedure without any further regulatory action.
Danish: CHMP godkendte de nye produktoplysninger og vedtog at afslutte artikel 20-proceduren uden yderligere indgreb.
English: Pending the outcome of the studies, the MAH committed to amend the SPC sections 4.2, 4.4, 4.5 (where relevant) and 5.1 as follows:
Danish: Mens resultatet af undersøgelserne afventes, forpligter indehaveren af markedsføringstilladelsen sig til at ændre produktresuméets afsnit 4.2, 4.4, 4.5 (når det er relevant) og 5.1 som følger:
English: Therefore, the results of this study provide evidence that the currently available product is providing the expected level of protective antibodies in all populations for which it is indicated.
Danish: Resultaterne af denne undersøgelse er derfor et vidnesbyrd om, at det aktuelle produkt giver det forventede niveau af beskyttende antistoffer hos alle de populationer, det er indiceret til.