FrancophonIA/ELRC3.0 huggingface dataset:
English: The available safety data confirmed that the adverse event (AE) profile of DNG/EE and the comparator products in the phase III trials is very similar, with none of the safety parameters raising any concerns.
Danish: De foreliggende sikkerhedsdata bekræftede, at bivirkningsprofilen af DNG/EE og sammenligningsprodukterne i fase III-undersøgelserne svarer nøje til hinanden, og at ingen af sikkerhedsparametrene giver anledning til betænkelighed.
English: This conclusion was reached considering that treatment would be necessary for at least 3 months for an effect to be seen, with the most prominent effect on acne seen after 6 months of treatment (as supported by the results of both phase III studies), and that in view of the still to be quantified risk of VTE, women should be assessed periodically to review the need for continuation of treatment.
Danish: Denne konklusion byggede på, at det er nødvendigt at behandle i mindst 3 måneder, for at der kan ses en virkning, og at den mest fremtrædende virkning på acne ses efter 6 måneders behandling (hvilket underbygges af resultaterne af begge fase III-undersøgelse), og at kvinder i betragtning af den endnu ikke kvantificerede risiko for VTE bør vurderes periodisk med henblik på nødvendigheden af at fortsætte behandlingen,
English: Considering the nature of the disorder, the observed benefits and the relative risks compared to available treatment alternatives and guideline recommendations, local therapies or oral antibiotic treatment should be tried first before resorting to a COC.
Danish: I betragtning af sygdommens art, de iagttagne fordele og de relative risici i forhold til tilgængelige behandlingsalternativer og anbefalingerne i retningslinjer bør lokal eller oral behandling med antibiotika forsøges først, inden der anvendes kombinerede orale kontraceptiva.
English: • The CHMP considered the totality of the available clinical studies, published literature and postmarketing experience, including responses from marketing authorisation holders (MAHs) on the efficacy of DNG/EE in the treatment of acne, and on the safety of these medicines, in particular regarding the risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE).
Danish: • CHMP gennemgik alt foreliggende materiale i form af kliniske undersøgelser, publiceret litteratur og erfaringer efter markedsføring, herunder markedsføringstilladelsesindehavernes besvarelser om virkningen af DNG/EE til behandling af acne og om disse lægemidlers sikkerhed, navnlig risikoen for venøse tromboemboliske hændelser (VTE) og arterielle tromboemboliske hændelser (ATE),
English: • The CHMP also noted that the initial acne indication was too broad and would unnecessarily expose women to a treatment with a potential higher risk of VTE when alternative and safer options for the treatment of acne are available.
Danish: • CHMP bemærkede også, at den oprindelige indikation var for bred og unødigt ville udsætte kvinder for en behandling med højere potentiel risiko for VTE, skønt der findes andre og sikrere behandlingsmuligheder for acne.
English: In view of the most prominent effect on acne seen after 6 months of treatment, paired with the still to be quantified risk of VTE, women should be assessed 3-6 months after initiating treatment and periodically thereafter to review the need for continuation of treatment.
Danish: I betragtning af, at den mest fremtrædende virkning på acne ses efter 6 måneders behandling, og at VTE-risikoen endnu ikke er kvantificeret, bør kvinder vurderes 3-6 måneder efter initiering af behandlingen og derefter periodisk med henblik på nødvendigheden af fortsat behandling.
English: • The CHMP is of the opinion that the benefits of dienogest/ethinylestradiol containing medicinal products continue to outweigh the risks in the second-line treatment of moderate acne in women who elect to use an oral contraceptive, provided that the medicinal products are only used after suitable topical therapies or oral antibiotic treatments have failed.
Danish: • CHMP er af den opfattelse, at fordelene ved lægemidler indeholdende dienogest/ethinylestradiol fortsat opvejer risiciene til andetvalgsbehandling af moderat acne hos kvinder, der vælger at bruge et oralt kontraceptivum, forudsat at lægemidlerne kun bruges, efter at egnede topikale behandlinger eller orale antibiotika har slået fejl.
English: At the time of triggering the referral, the UK considered that the benefit-risk analysis for the acne indication was not favourable based on insufficient data on the efficacy of the combination in the acne indication, an unacceptable safety profile, in particular regarding to the risk of venous thromboembolic events (VTE) and the fact that the target population covered by the abovementioned indication is broad and would unnecessarily expose women to a treatment with limited efficacy and to a potential higher risk of VTE when alternative and safer options for the treatment of acne are available.
Danish: Da Det Forenede Kongerige indbragte sagen, fandt det, at benefit/risk-forholdet for acneindikationen ikke var positivt på grund af utilstrækkelige data om virkningen af kombinationen ved acneindikationen, en uacceptabel sikkerhedsprofil, navnlig hvad angår risikoen for venøse tromboemboliske hændelser (VTE), og det forhold, at målpopulationen for ovennævnte indikation er bred og unødigt udsætter kvinder for en behandling med begrænset virkning og potentielt højere VTErisiko, selv om der findes andre og sikrere behandlingsmuligheder for acne.
English: The CHMP therefore agreed that the indication should be restricted to women who elect to use an oral contraceptive, and that a conscious and well-considered decision needs to be made when choosing this COC.
Danish: CHMP fandt derfor, at indikationen bør begrænses til kvinder, som vælger at bruge et oralt kontraceptivum, og at valget af det pågældende kontraceptivum bør være bevidst og velovervejet,
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for dienogest/ethinylestradiol containing medicinal products indicated in acne.
Danish: CHMP anbefaler derfor ændring af betingelserne for markedsføringstilladelserne for lægemidler indeholdende dienogest/ethinylestradiol.
English: However, the CHMP noted that there were no cases of VTE in the phase III studies and the safety data provided by MAHs does not raise any new safety concern.
Danish: CHMP bemærkede imidlertid, at der ikke forekom tilfælde af VTE i fase III-undersøgelserne, og at sikkerhedsdataene fra markedsføringstilladelsesindehaverne ikke gav anledning til nye sikkerhedsmæssige betænkeligheder.
English: • The CHMP considered that the efficacy of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg in the treatment of moderately severe acne in women in whom topical treatment or oral antibiotic was ineffective is well supported by phase III clinical trial data and further supported by a Cochrane review of combined oral contraceptive pills for treatment of acne.
Danish: • CHMP fandt, at virkningen af lægemidler indeholdende dienogest, 2 mg, og ethinylestradiol, 0,03 mg, til behandling af moderat svær acne hos kvinder, hos hvem topikal behandling eller oralt antibiotikum ikke var effektivt, er velunderbygget med kliniske fase III-undersøgelser og støttes yderligere af en Cochrane-gennemgang af kombinerede orale kontraceptiva til behandling af acne,
English: The CHMP also noted that in order to avoid unnecessarily exposing women to a treatment with a potential higher risk of VTE when alternative and safer options for the treatment of acne are available that the indication should be restricted to women who elect contraception, and that a conscious and wellconsidered decision needs to be made when choosing this COC.
Danish: CHMP bemærkede desuden, at for at undgå unødig eksponering af kvinder for en behandling med højere potentiel risiko for VTE end andre, sikrere behandlinger af acne bør indikationen indskrænkes til kvinder, der vælger kontraception, og at valg af det pågældende kombinerede orale kontraceptivum bør være bevidst og velovervejet.
English: In view of the above, the CHMP concluded that the benefit-risk balance of dienogest/ethinylestradiol containing products indicated in acne is favourable subject to changes to the product information as described above.
Danish: På ovenstående baggrund konkluderede CHMP, at benefit/risk-forholdet for lægemidler indeholdende dienogest/ethinylestradiol er positivt, forudsat at produktinformationen ændres som beskrevet ovenfor.
English: The CHMP, as a consequence, considers that the benefit-risk balance of dienogest/ethinylestradiol containing medicinal products indicated in acne remains favourable subject to the amendments to the product information described above.
Danish: CHMP finder følgelig, at benefit/risk-forholdet fortsat er positivt for lægemidler, der indeholder dienogest/ethinylestradiol og er indiceret til acne, forudsat at der foretages ovennævnte ændringer af produktinformationen.
English: Withdrawal of the marketing authorisation application for Graspa (eryaspase)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Graspa (eryaspase)
English: Asparaginase is an enzyme that has been used to treat cancer for many years, and is already approved under various trade names in the EU.
Danish: Asparaginase er et enzym, der har været anvendt til behandling af kræft i mange år, og det fås allerede under forskellige handelsnavne i EU.
English: Withdrawal of the marketing authorisation application for Graspa (eryaspase) EMA/817193/2016
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Graspa (eryaspase) EMA/817193/2016
English: On 14 November 2016, Erytech Pharma SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia.
Danish: Den 14. november 2016 meddelte Erytech Pharma SA officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Graspa til behandling af akut lymfoblastær leukæmi.
English: The medicine was intended for use in patients whose cancer was classed ‘Philadelphia chromosome negative' and had not responded to initial treatment, or had come back after treatment.
Danish: Lægemidlet forventedes anvendt hos patienter, hvis kræft er klassificeret som "Philadelphia chromosome negative" og ikke reagerer på den indledende behandling eller vender tilbage efter behandling.
English: In addition, the company had changed the way the asparaginase in the medicine was made, and the Committee asked for supportive information to show that this would not affect the effectiveness of the product.
Danish: Desuden havde virksomheden ændret den måde, som asparaginase fremstilles på, og udvalget bad om understøttende dokumentation for, at dette ikke ville have indflydelse på virkningen af lægemidlet.
English: Graspa is a cancer medicine that contains the active substance eryaspase (a version of the enzyme asparaginase enclosed in red blood cells compatible with the patient's blood group).
Danish: Graspa er et kræftlægemiddel, der indeholder det aktive stof eryaspase (en version af enzymet asparaginase, der befinder sig inde i røde blodlegemer, som er kompatible med patientens blodgruppe).
English: Graspa was expected to be used in combination with other cancer medicines to treat adults and children over 1 year of age who have acute lymphoblastic leukaemia (ALL), a cancer of white blood cells.
Danish: Graspa skulle anvendes i tillæg til andre kræftlægemidler til behandling af voksne og børn fra 1 år og opefter, som har akut lymfoblastær leukæmi (ALL), der er en form for kræft i de hvide blodlegemer.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Graspa?
English: Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.
Danish: producere deres egen asparagin og påvirkes mindre af lægemidlet.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because the additional data the CHMP considered necessary to support the application could not be obtained in the time available.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak ansøgningen tilbage, fordi den ikke kunne fremskaffe de yderligere data, som CHMP anså for nødvendige til at underbygge ansøgningen, inden for den angivne tidsfrist.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Graspa.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at underbygge ansøgningen om Graspa.
English: The asparaginase in Graspa is enclosed in red blood cells with the intention of helping protect the enzyme from being broken down in the body.
Danish: Asparaginasen i Graspa ligger inde i røde blodlegemer, der skal hjælpe med at beskytte enzymet mod at blive nedbrudt i kroppen.
English: The company provided data on Graspa, including the results of a main study involving 80 patients with ALL whose disease had come back after initial treatment or who had not responded to initial treatment, some of whom had an allergy to other products containing asparaginase.
Danish: Virksomheden fremlagde data om Graspa, herunder resultaterne af en hovedundersøgelse af 80 patienter med akut lymfoblastær leukæmi, hvis sygdom var vendt tilbage efter den indledende behandling, eller som ikke havde reageret på den indledende behandling.
English: The CHMP was concerned about the way the effectiveness of the medicine had been measured in the main study, and whether the results of this study could be extended to patients taking other combinations of cancer medicines.
Danish: Udvalget var ligeledes betænkelig ved, om resultaterne af undersøgelsen kunne udvides til patienter, der tog andre kombinationer af kræftlægemidler.
English: it can cause allergic reactions, but by enclosing it in red blood cells the risk of allergy is expected to be reduced.
Danish: Da asparaginase er et protein, kan det forårsage allergiske reaktioner, men ved at kapsle det ind i røde blodlegemer forventes risikoen for allergi at være reduceret.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Graspa could not have been approved for the treatment of ALL.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP haft visse betænkeligheder og var af den foreløbige opfattelse, at Graspa ikke kunne være blevet godkendt til behandling af akut lymfoblastær leukæmi.
English: Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 October 2006 for ALL.
Danish: Graspa blev udpeget som "lægemiddel til sjældne sygdomme" den 26. oktober 2006 mod akut lymfoblastær leukæmi.
English: The asparaginase in Graspa works by breaking up and reducing the blood levels of the amino acid asparagine.
Danish: Det aktive stof i Graspa, asparaginase, virker ved at nedbryde aminosyren asparagin og dermed nedsætte koncentrationen i blodet.
English: Cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die.
Danish: Kræftcellerne behøver denne aminosyre for at vokse og formere sig.
English: * efavirenz / emtricitabine / tenofovir disoproxil (as fumarate)
Danish: * efavirenz / emtricitabin / tenofovirdisoproxil (som fumarat)
English: EU number
Danish: EU-nummer.
English: Pharmaceutical Form Route of administration Packaging
Danish: Lægemiddelform Administrationsvej Emballage
English: 3 x 30 film-coated tablets
Danish: 3 x 30 filmovertrukne tabletter
English: Benefit continued to be seen with longer term treatment for 1 year.
Danish: Der var fortsat gavnlig virkning efter længerevarende behandling i et år.
English: After the starting dose, Imraldi is most often given every two weeks, but it may be given every week in certain situations.
Danish: Efter startdosen gives Imraldi sædvanligvis hver anden uge, men kan dog i visse tilfælde gives hver uge.
English: The full EPAR for Imraldi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Imraldi 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 Imraldi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imraldi.
English: Response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 68% of those given Imraldi responded (183 of 269 patients), compared with 67% of those given Humira (184 of 273 patients).
Danish: Efter 24 ugers behandling var responsen en forbedring på 20 % eller mere i symptomscoren: 68 % af dem, der fik Imraldi responderede (183 ud af 269 patienter), sammenlignet med 67 % af dem, der fik Humira (184 ud af 273 patienter).
English: Other information about Imraldi
Danish: Andre oplysninger om Imraldi
English: An alert card will also be given to patients.
Danish: Patienter får også udleveret et særligt patientinformationskort.
English: This means that Imraldi is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Imraldi meget nøje svarer til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU).
English: The reference medicine for Imraldi is Humira.
Danish: Referencelægemidlet for Imraldi er Humira.
English: What measures are being taken to ensure the safe and effective use of Imraldi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imraldi ?
English: The dose depends on the condition to be treated and in children is usually calculated according to the child's weight and height.
Danish: Dosen afhænger af sygdommen, der skal behandles, og hos børn skal den typisk beregnes ud fra barnets vægt og højde.
English: After training, patients or their carers may inject Imraldi if their doctor considers it appropriate.
Danish: Efter oplæring kan patienten eller dennes omsorgsgiver selv foretage indsprøjtningen med Imraldi, hvis lægen finder det hensigtsmæssigt.
English: Imraldi contains the active substance adalimumab and is a ‘biosimilar medicine'.
Danish: Imraldi indeholder det aktive stof adalimumab og er et "biosimilært lægemiddel".
English: What is Imraldi and what is it used for?
Danish: Hvad er Imraldi, og hvad anvendes det til?
English: Because Imraldi is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Imraldi.
Danish: Da Imraldi er et biosimilært lægemiddel, behøver de undersøgelser af virkning og sikkerhed, der er udført for Humira, ikke alle gentages for Imraldi.
English: Imraldi must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Danish: Imraldi må ikke anvendes hos patienter med aktiv tuberkulose eller andre svære infektioner eller til patienter med moderat til svær hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen).
English: Imraldi is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Danish: Imraldi bruges oftest til voksne, når deres tilstand er svær eller moderat svær, når tilstanden forværres, eller når de ikke kan få andre behandlinger.
English: It is not intended to provide practical advice on how to use Imraldi.
Danish: Det er ikke en praktisk vejledning i, hvordan Imraldi bør anvendes.
English: Why is Imraldi approved?
Danish: Hvorfor blev Imraldi godkendt?
English: Imraldi can only be obtained with a prescription and treatment should be started and supervised by specialist doctors experienced in the diagnosis and treatment of the conditions for which it is authorised.
Danish: Imraldi udleveres kun efter recept, og behandlingen bør indledes og overvåges af en speciallæge med erfaring i diagnosticering og behandling af de sygdomme, som det er godkendt til.
English: In addition, a main study involving 544 patients with moderate or severe rheumatoid arthritis despite treatment with methotrexate showed that Imraldi and Humira had similar effectiveness.
Danish: Desuden fremgik det af én hovedundersøgelse omfattende 544 patienter, der led af moderat til svær rheumatoid artritis trods behandling med methotrexat, at Imraldi og Humira havde samme virkning.
English: What are the risks associated with Imraldi?
Danish: Hvilke risici er der forbundet med Imraldi ?
English: All these data were considered sufficient to conclude that Imraldi will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Imraldi vil have de samme egenskaber som Humira, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: The active substance in Imraldi, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a chemical messenger in the body called tumour necrosis factor (TNF).
Danish: Det aktive stof i Imraldi, adalimumab, er et monoklonalt antistof (en type protein), der er opbygget, så det genkender og binder sig til et kemisk signalstof i kroppen, der kaldes tumornekrosefaktor (TNF).
English: The medicine is available as a solution for injection under the skin in a pre-filled syringe.
Danish: Lægemidlet fås som en opløsning til injektion under huden i en fyldt sprøjte.
English: For detailed information on the use of Imraldi in all conditions, including when it can be used in children, see the summary of product characteristics (also part of the EPAR).
Danish: Nærmere oplysninger om anvendelsen af Imraldi til alle sygdomme, herunder hvornår det kan anvendes til børn, fremgår af produktresuméet (også en del af denne EPAR).
English: In addition, a study in rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Danish: Derudover har en undersøgelse vedrørende rheumatoid arthritis vist, at lægemidlets virkning svarer til Humiras virkning ved disse sygdomme.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Danish: Andre sjældne alvorlige bivirkninger (som kan berøre 1 ud af 1 000 patienter) omfatter knoglemarvens svigtende produktion af blodceller, nervelidelser, lupus og lupuslignende sygdomme (hvor immunsystemet angriber patientens eget væv og forårsager betændelse og organskader) og StevensJohnsons syndrom (en alvorlig hudsygdom).
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat and sinuses, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Danish: De hyppigste bivirkninger ved adalimumab (som optræder hos mere end 1 ud af 10 patienter) er infektioner i næse og hals og sinuitis, reaktioner på injektionsstedet (rødme, kløe, blødning, smerte eller hævelse), hovedpine og knogle- og muskelsmerter.