FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Kiacta had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Kiacta ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Kiacta for the treatment of AA amyloidosis.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Kiacta til behandling af AA amyloidose.
English: In addition, following an inspection of the site where the data from the study were analysed, the CHMP had concerns over the reliability of the study's findings because of the way the analysis was carried out.
Danish: Efter en inspektion af stedet, hvor oplysningerne fra undersøgelsen var blevet analyseret, sætte udvalget spørgsmålstegn ved, om undersøgelsens resultater var pålidelige på grund af den måde analysen var blevet gennemført på.
English: The active substance in Kiacta, eprodisate disodium, is expected to work by interfering with the formation of fibrils of AA, preventing the deposits from building up in the organs.
Danish: Det aktive stof i Kiacta, dinatriumeprodisat, forventes at virke ved at påvirke dannelsen af AA-fibriller og dermed forhindre, at de aflejrer sig i organerne.
English: Amyloid A amyloidosis is caused by the build-up of insoluble ‘fibrils' (fine threads) of a protein called ‘amyloid A' (AA) in the organs of the body.
Danish: Amyloid A-amyloidose skyldes, at der ophober sig uopløselige “fibriller” (fine tråde) af et protein kaldet ‘amyloid A' (AA) i kroppens organer.
English: How is Kiacta expected to work?
Danish: Hvordan forventes Kiacta at virke?
English: The CHMP was concerned that the effectiveness of Kiacta in treating AA amyloidosis had not been demonstrated sufficiently in the single main study.
Danish: CHMP gav udtryk for betænkeligheder ved, at virkningen af Kiacta til behandling af AA-amyloidose ikke var blevet påvist i tilstrækkelig grad i den eneste hovedundersøgelse, som var blevet gennemført.
English: AA is produced in the body from a protein called ‘serum amyloid A', which is released by liver cells in response to inflammation.
Danish: AA fremstilles i kroppen af et protein kaldet ‘serumamyloid A', der frigives af leverceller som reaktion på betændelse.
English: Kiacta was expected to be used to treat amyloid A amyloidosis.
Danish: Kiacta forventedes anvendt til behandling af AA-amyloidose.
English: The most serious symptoms of the disease are caused by AA deposits building up in the kidneys and damaging them.
Danish: De alvorligste symptomer på sygdommen skyldes, at amyloid A aflejres i nyrerne og beskadiger dem.
English: The effectiveness of Kiacta was studied in one main study involving 183 patients with AA amyloidosis, in which Kiacta was compared with placebo (a dummy treatment).
Danish: Kiactas virkning blev undersøgt i en hovedundersøgelse af 183 patienter med AA amyloidose.
English: Pilisborosjenő 2097 Hungary
Danish: Pilisborosjenő 2097 Ungarn
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE/INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilla delse
English: They may also have episodes of depression.
Danish: Der kan også være episoder med depression.
English: Treatment must not last longer than 12 weeks.
Danish: Behandlingen må ikke vare længere end 12 uger.
English: The full EPAR and risk management plan summary for Aripiprazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Aripiprazole Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: To prevent manic episodes in adults, the same dose should be continued.
Danish: Til forebyggelse af maniske episoder hos voksne bør der fortsættes med samme dosis.
English: Aripiprazole Accord is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Danish: Aripiprazole Accord fås som tabletter (5, 10, 15 og 30 mg) og udleveres kun efter recept.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aripiprazole Accord.
English: The Committee recommended that Aripiprazole Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Aripiprazole Accord godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Aripiprazole Accord is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Accord anvendes så sikkert som muligt.
English: This means that Aripiprazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Danish: Det betyder, at Aripiprazole Accord svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Abilify.
English: In addition, the company that markets Aripiprazole Accord will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Danish: Virksomheden, der markedsfører Aripiprazole Accord, skal desuden udlevere oplysningsmateriale til patienterne eller deres omsorgsgivere og til lægerne, hvor det forklares, hvordan lægemidlet anvendes sikkert hos patienter mellem 13 og 17 år.
English: Other information about Aripiprazole Accord
Danish: Andre oplysninger om Aripiprazole Accord
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Accord is broken down in the body.
Danish: Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Accord i kroppen.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Danish: Aripiprazol menes hovedsagelig at virke ved delvis stimulation (dvs. som en “partiel agonist”) af receptorerne for neurotransmitterne dopamin og 5-hydroxytryptamin (også kaldet serotonin).
English: What are the benefits and risks of Aripiprazole Accord?
Danish: Hvilke fordele og risici er der forbundet med Aripiprazole Accord?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Aripiprazole Accord, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Aripiprazole Accord is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Danish: Aripiprazole Accord anvendes hos voksne til behandling af moderate til svære maniske episoder og forebyggelse af nye maniske episoder hos voksne, hos hvem lægemidlet tidligere har virket.
English: What measures are being taken to ensure the safe and effective use of Aripiprazole Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aripiprazole Accord?
English: The active substance in Aripiprazole Accord, aripiprazole, is an antipsychotic medicine.
Danish: Det aktive stof i Aripiprazole Accord, aripiprazol, er et antipsykotisk lægemiddel.
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: • skizofreni, der er en psykisk sygdom, som giver forskellige symptomer, bl.a. i form af tanke- og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger.
English: • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Danish: • bipolar lidelse type I, en psykisk sygdom med skiftende episoder med abnormt højt humør (maniske episoder) og perioder med normalt humør.
English: Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Abilify.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Accord i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
English: Aripiprazole Accord aripiprazole
Danish: Aripiprazole Accord aripiprazol
English: This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Danish: Det betyder, at aripiprazol aktiverer disse receptorer på samme måde som dopamin og 5-hydroxytryptamin, men ikke så kraftigt som neurotransmitterne.
English: Aripiprazole Accord is a medicine used in patients with the following mental illnesses:
Danish: Aripiprazole Accord er et lægemiddel, der anvendes ved følgende psykiske sygdomme:
English: For more information about treatment with Aripiprazole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aripiprazole Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because Aripiprazole Accord 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 Aripiprazole Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Aripiprazole Accord is used in patients aged 15 years or over;
Danish: Aripiprazole Accord anvendes til patienter over 15 år
English: It is not intended to provide practical advice on how to use Aripiprazole Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Aripiprazole Accord bør anvendes.
English: What is Aripiprazole Accord and what is it used for?
Danish: Hvad er Aripiprazole Accord, og hvad anvendes det til?
English: Because Aripiprazole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Danish: Da Aripiprazole Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Abilify.
English: For schizophrenia, the recommended starting dose is 10 or 15 mg per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Danish: Ved skizofreni er den anbefalede startdosis til voksne 10 eller 15 mg dagligt, efterfulgt af en vedligeholdelsesdosis på 15 mg én gang dagligt.
English: For further information, see the Summary of Product Characteristics (also part of the EPAR).
Danish: Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: Aripiprazole Accord is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Danish: Aripiprazole Accord anvendes desuden hos patienter over 13 år til behandling af moderate til svære maniske episoder i op til 12 uger
English: For practical information about using Aripiprazole Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Aripiprazole Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Aripiprazole Accord approved?
Danish: Hvorfor blev Aripiprazole Accord godkendt?
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg once a day, either on its own or in combination with other medicines.
Danish: Til behandling af maniske episoder ved bipolar sygdom er den anbefalede startdosis til voksne 15 mg én gang dagligt.
English: In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Danish: Til patienter mellem 15 og 17 år er startdosis 2 mg dagligt (hertil bruges et aripiprazol-produkt, der fås i flydende form).
English: Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Danish: Aripiprazol bevirker derfor, at hjerneaktiviteten bliver mere normal, så de psykotiske eller maniske symptomer mindskes og ikke kommer igen.
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Danish: Til behandling af maniske episoder hos patienter mellem 13 og 17 år er startdosis 2 mg dagligt (hertil bruges et aripiprazol-produkt i flydende form).
English: Aripiprazole Accord contains the active substance aripiprazole and is a ‘generic medicine'.
Danish: Aripiprazole Accord er et "generisk lægemiddel".
English: How has Aripiprazole Accord been studied?
Danish: Hvordan blev Aripiprazole Accord undersøgt?
English: How is Aripiprazole Accord used?
Danish: Hvordan anvendes Aripiprazole Accord?
English: How does Aripiprazole Accord work?
Danish: Hvordan virker Aripiprazole Accord?
English: Remicade received a marketing authorisation valid throughout the EU on 13 August 1999.
Danish: Remicade fik en markedsføringstilladelse med gyldighed i hele EU den 13. august 1999.
English: Other information about Remicade
Danish: Andre oplysninger om Remicade
English: It is usually used when other medicines or treatments have failed, in adults with the following diseases:
Danish: Det anvendes, når andre lægemidler eller behandlinger har slået fejl, til voksne med følgende sygdomme:
English: Further information on Remicade can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Remicade.
Danish: Yderligere information om Remicade findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Remicade.
English: As for all medicines, data on the use of Remicade are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Remicade løbende overvåget.
English: Remicade alone and in combination with azathioprine was more effective than azathioprine alone.
Danish: Remicade alene og i kombination med azathioprin var mere effektivt end azathioprin alene.
English: What measures are being taken to ensure the safe and effective use of Remicade?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Remicade?
English: The European Medicines Agency decided that Remicade's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Remicade opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: Patients who receive Remicade must be given a special reminder card.
Danish: Patienter, der får Remicade, skal have udleveret et særligt påmindelseskort.
English: An overview of Remicade and why it is authorised in the EU
Danish: En oversigt over Remicade, og hvorfor det er godkendt i EU
English: Remicade contains the active substance infliximab.
Danish: Remicade indeholder det aktive stof infliximab.
English: Side effects reported with Remicade are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Remicade vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The effects of adding Remicade to existing treatment have also been studied in 103 children and adolescents with Crohn's disease who were aged between 6 and 17 years.
Danish: Virkningen af at tilføje Remicade til den eksisterende behandling er desuden blevet undersøgt hos 103 børn og unge med Crohns sygdom i alderen 6-17 år.
English: For more information about using Remicade, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Remicade, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: In a study with 60 children aged between 6 and 17 years with ulcerative colitis 73% of patients responded to treatment with Remicade at week eight (44 out of 60).
Danish: I et studie med 60 børn i alderen 6-17 år med colitis ulcerosa havde 73 % af patienterne reageret på behandlingen med Remicade i uge 8 (44 ud af 60).
English: Remicade is given as an infusion lasting one or two hours.
Danish: Remicade gives som en infusion, der varer 1-2 timer.
English: A sixth study in 508 adult patients looked at the number of patients whose symptoms improved and who did not need additional treatment with corticosteroids (other medicines used in Crohn's disease).
Danish: Et sjette studie med 508 voksne patienter så nærmere på antallet af patienter, hvis symptomer blev bedre, og som ikke havde behov for tillægsbehandling med kortikosteroider (andre lægemidler til behandling af Crohns sygdom).
English: The patients were treated for 6 months with Remicade, another medicine azathioprine, or the combination of Remicade and azathioprine.
Danish: Patienterne blev behandlet i seks måneder med Remicade, et andet lægemiddel (azathioprin), eller en kombination af Remicade og azathioprin.
English: Why is Remicade authorised in the EU?
Danish: Hvorfor blev Remicade godkendt i EU?
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remicade or the infusion time may be slowed down.
Danish: For at mindske risikoen for bivirkninger ved infusionen kan patienterne få andre lægemidler før eller under behandlingen med Remicade, eller infusionen kan gives over længere tid.
English: The dose is 5 mg per kilogram for the other diseases.
Danish: Til de andre sygdomme er dosis 5 mg/kg legemsvægt.
English: Remicade is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Danish: Ved leddegigtanvendes Remicade sædvanligvis i en dosis på 3 mg/kg legemsvægt, dog kan dosis om nødvendigt øges.
English: Remicade is also used in patients aged between 6 and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Danish: Remicade anvendes desuden hos patienter mellem 6 og 17 år med svær, aktiv Crohns sygdom eller svær, aktiv ulcerøs kolitis, når andre lægemidler eller behandlinger ikke virker eller ikke kan anvendes.
English: Ulcerative colitis, ankylosing spondylitis and psoriatic arthritis For ulcerative colitis (728 adults), ankylosing spondylitis (70 adults) and psoriatic arthritis (104 adults), Remicade has been compared with placebo.
Danish: Colitis ulcerosa, ankyloserende spondylitis og psoriasisgigt For colitis ulcerosa (728 voksne), ankyloserende spondylitis (70 voksne) and psoriasisgigt (104 voksne) blev Remicade sammenlignet med placebo.
English: What are the risks associated with Remicade?
Danish: Hvilke risici er der forbundet med Remicade?
English: Remicade has been studied in a total of 1,432 patients with rheumatoid arthritis in two studies.
Danish: Remicade er blevet undersøgt hos 1 432 patienter med leddegigt i to studier.
English: Remicade must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Danish: Remicade må ikke anvendes til patienter med tuberkulose, andre svære infektioner eller moderat til svær hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen).
English: The most common side effects with Remicade (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Danish: De hyppigste bivirkninger ved Remicade (som optræder hos flere end 1 ud af 10 patienter) er virusinfektioner (såsom influenza eller forkølelsessår), hovedpine, infektioner i de øvre luftveje (forkølelser), sinusitis (bihulebetændelse), kvalme, mavesmerter, infusionsrelaterede reaktioner og smerter.
English: In Crohn's disease in adults, Remicade was compared with placebo (a dummy treatment) in 1,090 adults in four studies.
Danish: I studiet vedrørende Crohns sygdom hos voksne blev Remicade sammenlignet med placebo (en uvirksom behandling) hos 1 090 voksne i fire studier.
English: In a study in 627 adults with psoriasis, Remicade led to a greater improvement in symptoms than placebo.
Danish: I et studie med 627 voksne med psoriasis gav Remicade en større forbedring i symptomerne end placebo.
English: The card will include safety information about the medicine and a record of the dates and results of specific tests that the patient has had so these can be shared with any treating doctor.
Danish: Kortet indeholder sikkerhedsinformation om lægemidlet og en oversigt over datoer for og resultater af specifikke tests, som patienten har gennemgået, så de kan vises til andre behandlende læger.
English: What is Remicade and what is it used for?
Danish: Hvad er Remicade, og hvad anvendes det til?
English: Most of the patients showed a reduction in symptoms after adding Remicade to their existing treatment.
Danish: De fleste af patienterne fik færre symptomer efter at have tilføjet Remicade til den eksisterende behandling.
English: Remicade is an anti-inflammatory medicine.
Danish: Remicade et antiinflammatorisk lægemiddel.
English: The active substance in Remicade, infliximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Danish: Det aktive stof i Remicade, infliximab, er et monoklonalt antistof, dvs. en type protein, der er opbygget, så det genkender og binder sig til en særlig struktur (et antigen) i kroppen.
English: Remicade can only be obtained with a prescription and must be given under the supervision and monitoring of a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remicade can be used to treat.
Danish: Remicade udleveres kun efter recept og skal gives under tilsyn og overvågning af en speciallæge med erfaring i diagnosticering og behandling af de sygdomme, som Remicade anvendes til.