FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the failure of the HPS2-THRIVE study to meet the primary efficacy endpoints raised serious concerns regarding the efficacy of nicotinic acid/laropiprant in the indicated patient population, as overlap between this and the study populations is expected.
Danish: HPS2-THRIVE-undersøgelsens manglende succes med at opfylde de primære endepunkter for virkning rejser desuden alvorlige betænkeligheder vedrørende virkningen af nikotinsyre/laropiprant til den indicerede patientpopulation, da der må forventes overlapning mellem denne og de undersøgte populationer.
English: This increase was driven by differences observed in the system organ class blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin, which all favoured placebo.
Danish: Forskellene vedrørte navnlig systemorganklasserne blod og lymfesystem, mave-tarmkanalen, infektioner, metabolisme, muskuloskeletale system, luftveje og hud og var alle til fordel for placebo.
English: As part of the pharmacovigilance activities included in the adopted risk management plan, the marketing authorization holder (MAH) agreed to report on a randomised clinical study (HPS2-THRIVE1) designed to assess the incremental benefit of nicotinic acid/laropiprant versus placebo as add-on to simvastatin 40mg, with or without ezetimibe.
Danish: Som led i den lægemiddelovervågning, der indgår i den vedtagne risikostyringsplan, forpligtede markedsføringstilladelsesindehaveren sig til at indberette resultaterne af en randomiseret klinisk undersøgelse (HPS2-THRIVE1) med henblik på, i sammenligning med placebo, at vurdere fordelen ved anvendelse af nikotinsyre/laropiprant som tillægsbehandling til simvastatin, 40 mg, med eller uden ezetimib.
English: For the suspension to be lifted, the marketing authorisation holder for nicotinic acid/laropiprant shall provide the following:
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen For at suspenderingen kan ophæves, skal indehaveren af markedsføringstilladelsen for nikotinsyre/laropiprant forelægge følgende:
English: • The CHMP concluded that the statistically significant increase in the incidence of serious adverse events observed in the nicotinic acid/laropiprant group compared to the placebo group of the HPS2-THRIVE study raises serious concerns,
Danish: • CHMP konkluderede, at den statistisk signifikant højere forekomst af alvorlige bivirkninger hos gruppen på nikotinsyre/laropiprant end hos placebogruppen i HPS2-THRIVE-undersøgelsen giver anledning til alvorlige betænkeligheder,
English: • The CHMP considered that the failure of the HPS2-THRIVE study to meet the primary efficacy endpoints raises serious concerns regarding the efficacy of laropiprant/nicotinic acid,
Danish: • CHMP fandt, at den manglende opfyldelse af de primære endepunkter for virkning i HPS2THRIVE-undersøgelsen rejser alvorlige betænkeligheder vedrørende virkningen af laropiprant/nikotinsyre,
English: However, the new unexpected higher incidence of bleeding and infections in the study drug group compared to the placebo group was of concern.
Danish: Den uventede nye højere forekomst af blødninger og infektioner hos den gruppe, der fik forsøgslægemidlet, end i placebogruppen, gav imidlertid anledning til betænkelighed.
English: The risk of blood and lymphatic disorders was greater in the study drug group compared to the placebo group.
Danish: Risikoen for blod- og lymfesygdomme var større i den gruppe, der fik forsøgslægemidlet, end i placebogruppen.
English: There was a statistically significant increase in the incidence of non-fatal serious adverse events in the nicotinic acid/laropiprant (study drug) group compared to the placebo group.
Danish: Der var en statistisk signifikant større forekomst af ikke-fatale bivirkninger i grupperne behandlet med nikotinsyre/laropiprant (forsøgslægemidlet) end i placebogruppen.
English: Based on the known safety profile of the product, some adverse events were expected, such as elevations in transaminases, myopathy, some skin and gastrointestinal events and impaired glucose tolerance.
Danish: Nogle af bivirkningerne var forventelige ud fra produktets kendte sikkerhedsprofil, således forhøjede transaminaser, myopati, visse bivirkninger fra huden og mave-tarmkanalen samt nedsat glukosetolerance.
English: • The CHMP therefore considered that a patient population in which nicotinic acid/laropiprant has a clear favourable benefit-risk cannot be identified based on the current data.
Danish: • CHMP fandt derfor, at der på grundlag af de foreliggende data ikke kan udpeges en patientpopulation, hos hvilken nikotinsyre/laropiprant har et klart gunstigt benefit/risk-forhold,
English: Convincing data to identify a patient population in which the efficacy of nicotinic acid/laropiprant can be demonstrated, and in which the benefit clearly outweighs the risks, taking into account the new risks identified by the HPS2-THRIVE study.
Danish: Overbevisende data, der udpeger en patientpopulation, hos hvilken virkningen af nikotinsyre/laropiprant kan godtgøres, således at fordelene klart overstiger risiciene under hensyntagen til de nye risici, der er konstateret i HPS2-THRIVE-undersøgelsen.
English: The CHMP therefore concluded that the benefit-risk balance of nicotinic acid/laropiprant is affected adversely by the results from the HPS2-THRIVE study and is considered no longer favourable.
Danish: konkluderede CHMP, at resultaterne af HPS2-THRIVE-undersøgelsen betyder, at benefit/risk-forholdet for nikotinsyre/laropiprant er forskubbet i negativ retning og ikke længere kan anses for gunstigt.
English: To lift the suspension, the MAH would need to provide convincing data to identify a patient population in which the efficacy of nicotinic acid/laropiprant can be demonstrated, and in which the benefit clearly outweighs the risks, taking into account the new risks identified by the HPS2-THRIVE study (see Annex II).
Danish: For at opnå ophævelse af suspenderingen skal indehaveren af markedsføringstilladelsen fremlægge overbevisende data, der udpeger en patientpopulation, hos hvilken virkningen af nikotinsyre/laropiprant kan godtgøres, og hos hvilken fordelene klart overstiger risiciene under hensyntagen til de nye risici, der konstateret i HPS2-THRIVE-undersøgelsen (se bilag II).
English: For the suspension to be lifted, the MAH would need to provide convincing data to identify a patient population in which the efficacy of nicotinic acid/laropiprant can be demonstrated, and in which the benefit clearly outweighs the risks, taking into account the new risks identified by the HPS2-THRIVE study.
Danish: For at opnå ophævelse af suspenderingen skal indehaveren af markedsføringstilladelsen fremlægge overbevisende data, der godtgør virkningen af nikotinsyre/laropiprant og godtgør, at fordelene klart overstiger risiciene, herunder de nye risici, der er konstateret i HPS2-THRIVE-undersøgelsen.
English: Paroxetine
Danish: Paroxetin
English: The final opinion was converted into a Decision by the European Commission on 29 March 2005.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 29. marts
English: International Non-Proprietary Name (INN): paroxetine
Danish: Internationalt fællesnavn ( INN): paroxetine
English: Paroxetine containing medicinal products are approved for the treatment of:
Danish: Lægemidler indeholdende paroxetin er godkendt til behandling af:
English: - Panic disorder with and without agoraphobia
Danish: - panikangst med eller uden agorafobi
English: The referral procedure started on 26 June 2003.
Danish: Indbringelsesproceduren blev indledt den 26. juni 2003.
English: The CHMP adopted an opinion on 22 April 2004.
Danish: CHMP vedtog en udtalelse den 22. april 2004.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 31 REFERRAL
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31
English: Written explanations were provided by the Marketing Authorisation Holder by 1 September 2003, 13 February 2004, 2 April 2004 and 16 April 2004.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 1. september 2003, den 13. februar 2004, den 2. april 2004 og den 16. april 2005.
English: Paroxetine was first approved in 1990 as an antidepressant in the U.K.
Danish: Paroxetin blev godkendt første gang i 1990 som et antidepressivt lægemiddel i Det Forenede Kongerige.
English: Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 8 December 2004.
Danish: * Bemærkninger: Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP's udtalelse af 8. december 2004.
English: Paroxetine is a phenylpiperidine derivative and is a selective inhibitor of the presynaptic 5hydroxytryptamine (5-HT) reuptake.
Danish: Paroxetin er et phenylpiperidin-derivat og er en selektiv inhibitor af den præsynaptiske 5hydroxytryptamin (5-HT) reabsorption.
English: For more information please refer to: http://www.emea.eu.int/pdfs/human/referral/SSRIs/29783705en.pdf http://www.emea.eu.int/pdfs/human/referral/SSRIs/EMEA-H-A-31-651-SSRIs-en.pdf
Danish: For yderligere oplysninger se venligst: http://www.emea.eu.int/pdfs/human/referral/SSRIs/29783705en.pdf http://www.emea.eu.int/pdfs/human/referral/SSRIs/EMEA-H-A-31-651-SSRIs-en.pdf
English: Paroxetine inhibits the neuronal uptake of serotonin and thereby facilitates serotonergic transmission.
Danish: Paroxetin hæmmer den neuronale absorption af serotonin og letter derved serotonerg transmission.
English: - Major depressive episode
Danish: - major depression
English: - Post-traumatic stress disorder
Danish: - post-traumatisk stress-syndrom
English: On 13 June 2003, UK referred the matter to the EMEA under Article Article 31 of Directive 2001/83/EC, as amended, for paroxetine containing medicinal products.
Danish: Den 13. juni 2003 indbragte Det Forenede Kongerige en sag for EMEA i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, vedrørende lægemidler indeholdende stoffet paroxetin.
English: 29 March 2005 CHMP/187488/2004
Danish: 29. marts 2005 CHMP/187488/2004
English: Oral explanations were given on 20 April
Danish: Der blev afgivet mundtlige redegørelser den 20. april 2004.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III and the conditions of the marketing authorisations in the Annex IV.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, det ændrede produktresumé findes i bilag III, og betingelserne for markedsføringstilladelsen findes i bilag IV.
English: The reasons for referral concerned the risk of emotional lability, including hostility and suicidal behaviour in children and adolescents and withdrawal reactions with paroxetine.
Danish: Indbringelsen fandt sted på grund af risikoen for emotionel labilitet, inklusive fjendtlighed og selvmordsadfærd blandt børn og unge og abstinensreaktioner med paroxetin.
English: Based on evaluation of the available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of paroxetine containing medicinal products remains favourable.
Danish: På grundlag af vurderingen af de foreliggende oplysninger og rapportørens evalueringsrapporter var CHMP af den opfattelse, at benefit/risk-forholdet for lægemidler indeholdende paroxetin fortsat er gunstigt.
English: An updated warning in relation to children and adolescents was recommended to be included in the Product Information.
Danish: Det blev anbefalet, at der i produktoplysningerne blev medtaget en ajourført advarsel i relation til børn og unge.
English: - Obsessive compulsive disorder
Danish: - obsessiv-kompulsiv tilstand
English: Following the adoption of the CHMP Opinion for paroxetine, the CHMP further reviewed the risk of suicidal behaviour in children and adolescents treated with this type of medicines.
Danish: Efter vedtagelsen af CHMP's udtalelse om paroxetin undersøgte CHMP yderligere risikoen for suicidal adfærd hos børn og unge behandlet med denne form for lægemidler.
English: The final CHMP opinion was adopted on 8 December 2004 recommending the variation of the Marketing Authorisations in accordance with the Summary of Product Characteristics for paroxetine containing medicinal products.
Danish: CHMP's endelige udtalelse blev vedtaget den 8. december 2004, og denne anbefaler ændring af markedsføringstilladelsen i overensstemmelse med produktresuméet for lægemidler indeholdende paroxetin.
English: During the referral procedure Dr. B. van Zwieten Boot took over the Rapporteurship from Dr. F. Lekkerkerker and Dr. F. Rotblat took over from Dr. P. Arlett.
Danish: Under indbringelsesproceduren overtog Dr. Barbara van Zwieten Boot Dr. Frits Lekkerkerkers rapportørpost, og Dr. Frances Rotblat overtog Dr. Peter Arletts rapportørpost.
English: Subsequently national Marketing Authorisations have been granted in all EU Member States for the treatment of various psychiatric disorders.
Danish: Efterfølgende er paroxetin blevet godkendt til behandling af forskellige psykiatriske lidelser i alle EU-medlemsstaterne.
English: The Rapporteur and Co-Rapporteur appointed were: Dr. F. Lekkerkerker and Dr. P. Arlett, respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis Dr. Frits Lekkerkerker og Dr. Peter Arlett.
English: - Generalised anxiety disorder
Danish: - generaliseret angstsyndrom
English: - Social anxiety disorders / social phobia
Danish: - socialfobi
English: This summary was last updated in 09/2013.
Danish: Dette sammendrag blev sidst ajourført i 09/2013
English: The full EPAR for Inflectra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Inflectra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Some side effects, including infections, may be more common in children than in adults.
Danish: Nogle bivirkninger, herunder infektioner, kan optræde oftere hos børn end hos voksne.
English: This is a summary of the European public assessment report (EPAR) for Inflectra.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Inflectra.
English: The company will also carry out studies to confirm the long-term safety of the medicine.
Danish: Virksomheden skal desuden udføre undersøgelser, der bekræfter lægemidlets sikkerhed på lang sigt.
English: It is usually used when other medicines or treatments have failed, in adults with the following diseases:
Danish: Der anvendes sædvanligvis, når andre lægemidler eller behandlinger har slået fejl hos voksne med følgende sygdomme:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inflectra on 10 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Inflectra den 10. september 2013.
English: A risk management plan has been developed to ensure that Inflectra is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Inflectra anvendes så risikofrit som muligt.
English: Other information about Inflectra
Danish: Andre oplysninger om Inflectra
English: What is Inflectra and what is it used for?
Danish: Hvad er Inflectra, og hvad anvendes det til?
English: This means that Inflectra is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Inflectra and the reference medicine contain the same active substance.
Danish: Det betyder, at Inflectra svarer til et biologisk lægemiddel (”referencelægemidlet”), der allerede er godkendt i Den Europæiske Union (EU), og at Inflectra og referencelægemidlet indeholder samme aktive stof.
English: What measures are being taken to ensure the safe and effective use of Inflectra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Inflectra?
English: Why is Inflectra approved?
Danish: Hvorfor blev Inflectra godkendt?
English: The dose is 5 mg per kilogram for the other diseases.
Danish: Til de andre sygdomme er dosis 5 mg pr. kg legemsvægt.
English: Inflectra was compared with Remicade in one main study involving 606 adult patients with rheumatoid arthritis.
Danish: Inflectra blev sammenlignet med Remicade i én hovedundersøgelse hos 606 voksne med reumatoid arthritis.
English: The main measure of effectiveness was the change in symptoms.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringerne i symptomer.
English: Inflectra is given as an infusion lasting one or two hours.
Danish: Inflectra gives som en infusion, der varer 1-2 timer.
English: Inflectra is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Danish: Ved reumatoid arthritis anvendes Inflectra sædvanligvis i en dosis på 3 mg/kg legemsvægt, dog kan dosis om nødvendigt øges.
English: Patients received either Inflectra or Remicade in addition to methotrexate for 30 weeks.
Danish: Patienterne fik enten Inflectra eller Remicade som tillægsbehandling til methotrexat i 30 uger.
English: The most common side effects with Inflectra (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 Inflectra (som ses hos flere end 1 ud af 10 patienter) er virusinfektioner (såsom influenza eller forkølelsessår), hovedpine, øvre luftvejsinfektioner (forkølelse), sinuitis (bihulebetændelse), kvalme, mavesmerter, infusionsrelaterede reaktioner og smerter.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Inflectra or the infusion time may be slowed down.
Danish: For at mindske risikoen for infusionsbetingede reaktioner får patienterne andre lægemidler før eller efter behandlingen med Inflectra, eller infusionen gives over længere tid.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Inflectra has been shown to have a comparable quality, safety and efficacy profile to Remicade.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Inflectra i overensstemmelse med EU-kravene er påvist at have en kvalitet, sikkerhed og virkning, der svarer til Remicade.
English: Inflectra 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: Inflectra må ikke anvendes hos patienter med tuberkulose, andre svære infektioner eller moderat til svært hjertesvigt (manglende evne af hjertet til at pumpe tilstrækkeligt med blod rundt i kroppen).
English: Patients who receive Inflectra must be given a special alert card that summarises the safety information about the medicine.
Danish: Patienter, der får Inflectra, skal have udleveret et særligt advarselskort, der sammenfatter de vigtigste sikkerhedsoplysninger om lægemidlet.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Danish: Nærmere oplysninger om biosimilære lægemidler findes i dokumentet med spørgsmål og svar her.
English: It is not intended to provide practical advice on how to use Inflectra.
Danish: Det er ikke en praktisk vejledning i, hvordan Inflectra bør anvendes.
English: An additional study was also carried involving 250 patients with ankylosing spondylitis out to show that Inflectra produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.
Danish: Der blev desuden udført en undersøgelse hos 250 patienter med ankyloserende spondylitis for at vise, at Inflectra frembringer samme mængde aktivt stof i kroppen som referencelægemidlet Remicade.
English: The reference medicine for Inflectra is Remicade.
Danish: Referencelægemidlet for Inflectra er Remicade.
English: What are the risks associated with Inflectra?
Danish: Hvilke risici er der forbundet med Inflectra?
English: ‘Inflectra is a ‘biosimilar' medicine.
Danish: Inflectra er et ‘biosimilært' lægemiddel.
English: In addition, the company that markets Inflectra will provide educational material to doctors who are expected to prescribe the medicine in adults and children including information on the safety of the medicine and an alert card to be given to patients.
Danish: Desuden skal den virksomhed, der markedsfører Inflectra, udlevere oplysningsmateriale til de læger, som forventes at ordinere lægemidlet til børn og voksne, herunder information om lægemidlets sikkerhed og et advarselskort, som skal udleveres til patienterne.
English: For more information about treatment with Inflectra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Inflectra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Inflectra can be used to treat.
Danish: Inflectra fås kun på recept, og det bør ordineres og behandlingen indledes og overvåges af en speciallæge med erfaring i diagnosticering og behandling af de sygdomme, Inflectra kan anvendes til.
English: After 30 weeks of treatment Inflectra was as effective as Remicade with around 60 % of patients responding to treatment with either medicine.
Danish: Efter 30-ugers behandling var Inflectra ligeså effektivt som Remicade, idet begge lægemidler virkede hos omkring 60 % af patienterne.
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Danish: Ved at blokere TNF-alfa bedrer infliximab inflammationstilstanden og de andre symptomer på sygdommen.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Danish: Et monoklonalt antistof er en type protein, der er opbygget, så det genkender og binder sig til en bestemt struktur, der kaldes et antigen og findes i organismen.
English: Inflectra is an anti-inflammatory medicine that contains the active substance infliximab.
Danish: Inflectra er et antiinflammatorisk lægemiddel, der indeholder det aktive stof infliximab.
English: The active substance in Inflectra, infliximab, is a monoclonal antibody.
Danish: Det aktive stof i Inflectra, infliximab, er et monoklonalt antistof.
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Inflectra is used to treat.
Danish: Dette signalstof er en medvirkende årsag til inflammationstilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Inflectra.
English: Inflectra must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Inflectra.
Danish: Inflectra må ikke anvendes hos patienter, der tidligere har oplevet overfølsomhed (allergi) over for infliximab, eller som er overfølsom for museproteiner eller andre af indholdsstofferne i Inflectra.
English: How is Inflectra used?
Danish: Hvordan anvendes Inflectra?