FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Dectova are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Dectova løbende overvåget.
English: Other information about Dectova
Danish: Andre oplysninger om Dectova
English: The active substance in Dectova, zanamivir, prevents the flu virus from spreading by blocking some of the enzymes on the surface of the virus called neuraminidases.
Danish: Det aktive stof i Dectova, zanamivir, forhindrer influenzavirussen i at sprede sig ved at blokere nogle af de enzymer på virussets overflade, der kaldes neuraminidaser.
English: Dectova is expected to be effective against some flu strains that do not respond to other flu treatments.
Danish: Dectova forventes at være effektivt mod visse influenzastammer, der ikke reagerer på andre influenzabehandlinger.
English: Side effects reported with Dectova are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Dectova vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Dectova is given as an infusion (drip) into a vein.
Danish: Dectova gives som en infusion (drop) i en vene.
English: Dectova is an antiviral medicine used to treat complicated and potentially life-threatening influenza (flu) caused by either the influenza A or B virus in adults and children from 6 months of age.
Danish: Dectova er et antiviralt lægemiddel, der anvendes til behandling af kompliceret og potentielt livstruende influenza forårsaget af enten influenzavirus A eller B hos voksne og børn fra 6månedersalderen.
English: The European Medicines Agency therefore decided that Dectova's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Dectova opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: However, because uncertainties remain about the size of the effect of Tamiflu (and by extension the size of Dectova's effect), Dectova has been authorised under ‘exceptional circumstances'.
Danish: Da der imidlertid stadig er usikkerhed med hensyn til Tamiflus virkningsgrad (og dermed Dectovas virkningsgrad), er Dectova blevet godkendt under "særlige omstændigheder".
English: Since Dectova has been authorised under exceptional circumstances, the company that markets the medicine will conduct two observational studies in patients with complicated influenza to obtain further data on the effectiveness.
Danish: Da Dectova er godkendt under særlige omstændigheder, skal virksomheden, der markedsfører lægemidlet, gennemføre to observationsstudier hos patienter med kompliceret influenza for at opnå yderligere data om virkningen.
English: For more information about using Dectova, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Dectova, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Dectova contains the active substance zanamivir.
Danish: Dectova indeholder det aktive stof zanamivir.
English: What measures are being taken to ensure the safe and effective use of Dectova?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dectova?
English: Dectova works on neuraminidases of both influenza A (the most common type) and influenza B viruses.
Danish: Dectova virker på neuraminidaserne både ved influenzavirus A (den mest almindelige type) og influenzavirus B.
English: The most common side effects with Dectova (which may affect up to 1 in 10 people) are diarrhoea, raised levels of transaminases (liver enzymes), liver injury and rash.
Danish: De hyppigste bivirkninger ved Dectova (som kan forekomme hos op til 1 ud af 10 personer) er diarré, forhøjet niveau af transaminaser (leverenzymer), leverskader og udslæt.
English: The main measure of effectiveness was how long it took for patients to leave hospital or for 4 out of the following 5 flu symptoms to resolve: fever, decreased levels of oxygen in the blood, raised breathing rate, raised heart rate and abnormal blood pressure.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor lang tid der gik, inden patienterne kunne udskrives, eller at fire af følgende fem influenzasymptomer var forsvundet: feber, for lav iltmængde i blodet, øget vejrtrækningshastighed, øget hjertefrekvens og unormalt blodtryk.
English: An overview of Dectova and why it is authorised in the EU
Danish: En oversigt over Dectova og hvorfor det er godkendt i EU
English: Although Tamiflu was used as the comparator, there is some uncertainty about how effective this medicine is in complicated influenza as it has not been compared with placebo (a dummy treatment) in hospitalised influenza patients.
Danish: Selv om Tamiflu blev anvendt som sammenligningspræparat, er der en vis usikkerhed med hensyn til, hvor effektivt dette lægemiddel er til kompliceret influenza, da det ikke er blevet sammenlignet med placebo (en virkningsløs behandling) hos indlagte patienter med influenza.
English: Further evidence on benefits of Dectova comes from supporting clinical studies and other laboratory studies.
Danish: Den yderligere dokumentation om fordelene ved Dectova er fra understøttende kliniske studier og andre laboratoriestudier.
English: Evidence from laboratory and other clinical studies also supported the effectiveness of Dectova.
Danish: Dokumentation fra laboratoriestudier og andre kliniske studier underbyggede også virkningen af Dectova.
English: Dectova can only be obtained with a prescription.
Danish: Dectova udleveres kun efter recept.
English: Dectova has been shown to work as well as Tamiflu (the standard of care for complicated flu) in one main study involving 626 patients who had been hospitalised.
Danish: Dectova har vist sig lige så effektivt som Tamiflu (standardbehandlingen for kompliceret influenza) i et hovedstudie med 626 patienter, der havde været indlagt på hospitalet.
English: What is Dectova and what is it used for?
Danish: Hvad er Dectova, og hvad anvendes det til?
English: Why is Dectova authorised in the EU?
Danish: Hvorfor blev Dectova godkendt i EU?
English: It took around 5.1 days for symptoms to resolve or patients to leave the hospital with Dectova compared with 5.6 days with Tamiflu.
Danish: Med Dectova tog det ca. 5,1 dage, før symptomerne var forsvundet eller patienterne kunne udskrives sammenlignet med 5,6 dage med Tamiflu.
English: What information is still awaited for Dectova?
Danish: Hvilke oplysninger afventes der stadig for Dectova?
English: What are the risks associated with Dectova?
Danish: Hvilke risici er der forbundet med Dectova?
English: A main study showed that Dectova works as well as Tamiflu, with comparable time to discharge patients from hospital or resolution of most of the influenza symptoms.
Danish: Det fremgik af et hovedstudie, at Dectova virker lige så godt som Tamiflu, idet tiden inden udskrivningen af patienterne og tiden inden de fleste af influenzasymptomerne forsvandt svarede til hinanden.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dectova 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 Dectova.
English: How is Dectova used?
Danish: Hvordan anvendes Dectova?
English: What benefits of Dectova have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Dectova?
English: How does Dectova work?
Danish: Hvordan virker Dectova?
English: “Paediatric patients
Danish: "Pædiatriske patienter
English: The company responded to these points on 30 November 2006.
Danish: Virksomheden besvarede disse punkter den 30. november 2006.
English: A Request for Supplementary Information was adopted on 16 November 2006.
Danish: En anmodning om supplerende oplysninger blev vedtaget den 16. november 2006.
English: BACKGROUND INFORMATION*
Danish: BAGGRUNDSOPLYSNINGER*
English: Notes:
Danish: Bemærkninger:
English: Section 4.1 (Indication):
Danish: Afsnit 4.1 (indikation):
English: The Member States competent authorities will continue to keep the product under regular review.
Danish: De kompetente myndigheder i medlemsstaterne fører fortsat løbende tilsyn med produktet.
English: The Applicant further agreed to the proposed wording by the CHMP as follows:
Danish: Ansøgeren tilsluttede sig endvidereden af CHMP foreslåede ordlyd som følger:
English: The CHMP appointed Dr. Broich (DE) as Rapporteur and Dr. Prieto (ES) as CoRapporteur.
Danish: CHMP udpegede dr. Broich (DE) som rapportør og dr. Prieto (ES) som medrapportør.
English: The information given in this document and Annexes reflect only the CHMP Opinion dated 14 December 2006.
Danish: Oplysningerne i nærværende dokument og de tilhørende bilag afspejler alene CHMP's udtalelse af 14. december 2006.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II and the amended Summary of Product Characteristics in Annex III.
Danish: Listen over de berørte produktnavne findes i bilag I. De faglige konklusioner fremgår af bilag II, det ændrede produktresumé af bilag III.
English: Gadograf is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Danish: Gadograf anbefales ikke til patienter under 18 år på grund af manglende data om virkning og sikkerhed.
English: The CHMP opinion was converted into a Decision by the European Commission on 13 April
Danish: CHMP's udtalelse blev den 13. april 2007 omarbejdet til en beslutning af EuropaKommissionen.
English: Section 4.2 (Posology):
Danish: Afsnit 4.2 (dosering):
English: Having considered the grounds for the referral triggered by Spain, the CHMP, during its May 2006 plenary meeting, adopted a List of Questions and a TT for a referral procedure under Article 36.
Danish: Efter at have gennemgået Spaniens begrundelse for indbringelsen vedtog CHMP på sit plenarmøde i maj 2006 en liste over spørgsmål og en tidsplan for en henvisningsprocedure i overensstemmelse med artikel 36.
English: After finalisation of the procedure the Spanish Agency for Medicines and Health Products initiated a referral for arbitration to the CHMP under article 36.1 of Directive 2001/83/EC.
Danish: Efter procedurens afslutning indbragte den spanske lægemiddelstyrelse sagen for CHMP med henblik på mægling i overensstemmelse med artikel 36, stk. 1, i direktiv 2001/83/EF.
English: In June 2005, a MR procedure started for a type II variation to add the indication of “Contrast enhanced MRI of other body regions: liver, kidneys” and the following posology and method of administration/dosage: “CE-MRI of other body regions: The recommended dose for adults is 0.1 mmol per kilogram body weight (mmol/kg BW).
Danish: I juni 2005 indledtes en gensidig anerkendelsesprocedure for en type II-ændring med henblik på tilføjelse af indikationen "Kontrastforstærkning ved MRI af andre kropsregioner: lever og nyrer" og med følgende dosering og administrationsmåde: "CE-MRI af andre kropsregioner: Den anbefalede dosis til voksne er 0,1 mmol pr. kg legemsvægt, svarende til 0,1 ml/kg legemsvægt af en 1,0 M opløsning".
English: Concerns were further raised with regards to the Paediatric Indication and the use of the comparator Magnevist.
Danish: Betænkelighederne vedrørte desuden den pædiatriske indikation og anvendelsen af sammenligningspræparatet Magnevist.
English: Magnevist is not approved "to classify focal lesions [of liver or kidney] as benign or malignant" throughout the EU and it was questioned whether it would support the granting of an indication for which Magnevist has not been approved.
Danish: Magnevist er ikke godkendt i hele EU til "klassificering af fokale forandringer [i lever eller nyrer] som benigne eller maligne", og der blev sat spørgsmålstegn ved, om EU skulle tilslutte sig godkendelse af en indikation, som Magnevist ikke var godkendt til.
English: Gadovist/Gadograf was approved for “Contrast enhancement in cranial and spinal magnetic resonance imaging” in Germany in January 2000 and subsequently in June 2000 in the EU and Norway via the mutual recognition procedure (MRP).
Danish: Gadovist/Gadograf blev godkendt til "Kontrastforstærkning ved kraniel og spinal magnetisk resonans imaging (MRI)" i Tyskland i januar 2000, og derefter i EU og Norge ved den gensidige anerkendelsesprocedure i juni 2000.
English: Gadovist/Gadograf 1.0 mmol/ml contains gadobutrol, a neutral macrocyclic gadolinium (Gd) complex with contrast-enhancing properties, which is used for magnetic resonance imaging (MRI).
Danish: Gadovist/Gadograf indeholder 1,0 mmol/ml gadobutrol, et neutralt, makrocyklisk kompleks af gadolinium (Gd), der har kontrastforstærkende egenskaber og anvendes til magnetisk resonans imaging (MRI).
English: The Applicant was asked to justify the choice of this comparator and the clinical utility of Gadovist/Gadograf with respect to diagnostic thinking, therapeutic management and clinical outcome.
Danish: Ansøgeren blev anmodet om at begrunde valget af dette sammenligningspræparat og den kliniske værdi af Gadovist/Gadograf for diagnosticeringen, behandlingen og det kliniske resultat.
English: The questions identified pertained to insufficient data on the evaluation of disseminated liver disease that could justify an extrapolation to the general population undergoing examinations of liver and kidney.
Danish: Spørgsmålene vedrørte utilstrækkelige oplysninger om vurderingen af dissemineret leversygdom, som eventuelt kan berettige, at der ekstrapoleres til hele den population af patienter, som får foretages undersøgelse af lever og nyrer.
English: In its response the Applicant addressed the issue of clinical utility by comparing Gadovist-enhanced with Magnevistenhanced MRI and underlined the diagnostic efficacy of Gadovist/Gadograf.
Danish: I sin besvarelse redegjorde ansøgeren for spørgsmålet om klinisk værdi gennem en sammenligning af Gadograf-forstærket og Magnevist-forstærket MRI og understrege de den diagnostiske effektivitet af Gadovist/Gadograf.
English: MRI is a widely used technique for the evaluation and detection of diffuse liver disease as well as for further characterisation of focal liver disease.
Danish: MRI er en almindeligt anvendt teknik til påvisning og vurdering af diffus leversygdom samt til nærmere karakterisering af fokal leversygdom.
English: A label extension to the indication “Contrast-enhanced Magnetic resonance angiography” (CE-MRA) followed in November
Danish: Indikationen blev udvidet med "Kontrastforstærkning ved magnetisk resonansangiografi (CE-MRA)" i november 2003.
English: Gd-based contrast agents are frequently administered prior to contrast-enhanced dynamic liver MRI and may improve both detection and classification of focal liver lesions.
Danish: Gd-baserede kontraststoffer administreres ofte før kontrastforøget dynamisk MRI af leveren og kan forbedre resultaterne ved påvisning og klassificering af fokale leverforandringer.
English: “Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant”.
Danish: "Kontrastforstærket MRI af lever eller nyrer hos patienter, hos hvilke fokale forandringer i lever eller nyrer er stærkt sandsynlige eller påvist, med henblik på klassificering af sådanne forandringer som benigne eller maligne".
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 36(1) REFERRAL
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER UDTALELSE EFTER EN INDBRINGELSE I HENHOLD TIL ARTIKEL 36, stk. 1 FOR Gadograf/Gadovist Internationalt fællesnavn (INN): Gadobutrol
English: 500 mg Powder for concentrate for solution for infusion
Danish: 500 mg Pulver til koncentrat til infusionsvæske
English: Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration
English: Intravenous use vial (glass)
Danish: Intravenøs anvendelse Hætteglas (glas)
English: Packaging Package size
Danish: Lægemiddelform Indgivelsesvej Emballage
English: This means that the medicine will no longer be available.
Danish: Det betyder, at lægemidlet ikke længere vil være tilgængeligt.
English: The review of flupirtine was initiated on 26 October 2017 at the request of Germany, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af flupirtin blev iværksat på foranledning af Tyskland den 26. oktober 2017 i henhold til artikel 31 i direktiv 2001/83/EF.
English: They are available under several trade names and in different formulations.
Danish: Lægemidlerne markedsføres under forskellige handelsnavne og i forskellige formuleringer.
English: • Alternative treatment options are available.
Danish: • Der findes alternative behandlingsmuligheder.
English: More about the procedure
Danish: Yderligere oplysninger om proceduren
English: 2 These cases have been reported in the European database of suspected adverse drug reaction reports (Eudravigilance) between April 2013 and December 2017
Danish: 2 Disse tilfælde er indberettet i den europæiske database over formodede bivirkninger (Eudravigilance) mellem april 2013 og december 2017.
English: The opening of these channels reduces the excessive electrical activity that leads to many pain states.
Danish: Åbning af disse kanaler nedsætter den elektriske overaktivitet, der er årsag til mange smertetilstande.
English: • Healthcare professionals should consider alternative treatments for patients.
Danish: • Sundhedspersoner bør overveje alternative behandlinger til patienterne.
English: The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position on 21 March 2018.
Danish: PRAC's anbefalinger blev overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh), som vedtog et standpunkt den 21. marts 2018.
English: Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Estonia, Germany, Latvia, Lithuania, Luxembourg, Poland, Portugal, and Slovakia.
Danish: Lægemidler indeholdende flupirtin har været godkendt siden midten af 1980'erne og markedsføres på nuværende tidspunkt i følgende EU-medlemsstater: Estland, Tyskland, Letland, Litauen, Luxembourg, Polen, Portugal og Slovakiet.
English: • Patients with any questions should speak to their healthcare professional.
Danish: • Patienter, der har spørgsmål, bør kontakte deres sundhedsperson.
English: Flupirtine works as a ‘selective neuronal potassium channel opener'.
Danish: Flupirtin virker som en "selektiv neuronal kaliumkanalåbner".
English: Serious liver problems continued to be reported despite previous restrictions in use
Danish: Der indberettes fortsat alvorlige leverproblemer på trods af restriktioner for brugen
English: Since the CMDh adopted its position by consensus, it will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Danish: Da CMDh's standpunkt blev vedtaget med konsensus, vil det blive direkte implementeret i de medlemsstater, hvor lægemidlerne er godkendt, i henhold til den vedtagne tidsplan.
English: • Healthcare professionals in the EU countries where flupirtine is marketed will receive a letter with detailed information on the appropriate actions to be taken, including when the medicine will become unavailable.
Danish: • Sundhedspersoner i de EU-medlemsstater, hvor flupirtin markedsføres, vil modtage et brev med detaljerede oplysninger om de relevante tiltag, herunder hvornår lægemidlet ikke længere fås på markedet.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/153044/2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23.
English: Withdrawal of pain medicine flupirtine endorsed
Danish: Tilbagekaldelse af smertemedicinen flupirtin vedtaget
English: While the use of flupirtine-containing products has decreased, the measures implemented have not been effective at minimising the risk.
Danish: Selvom brugen af flupirtinholdige lægemidler er faldet, har de gennemførte foranstaltninger ikke været tilstrækkeligt effektive til at minimere risikoen.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev først foretaget af udvalget for risikovurdering inden for lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte en række anbefalinger.
English: It also assessed cases of serious liver damage reported since the 2013 review.
Danish: I gennemgangen blev der også set nærmere på de alvorlige tilfælde af leverskade, der er blevet indberettet siden 2013-gennemgangen.
English: • Six observational studies showed a lack of compliance with the measures that were introduced to minimise the risk of hepatotoxicity.
Danish: • Seks observationsundersøgelser har vist manglende overholdelse af de foranstaltninger, der blev indført for at minimere risikoen for levertoksicitet.
English: In order to protect public health, the CMDh endorsed the PRAC recommendation to withdraw the marketing authorisations of flupirtinecontaining medicines.
Danish: For at beskytte den offentlige sundhed vedtog CMDh at støtte PRAC's anbefaling om at tilbagekalde markedsføringstilladelserne for flupirtinholdige lægemidler.
English: The CMDh therefore agreed that patients taking flupirtine-containing medicines continue to be exposed to serious risks which outweigh the benefits of these medicines.
Danish: CMDh var derfor af den opfattelse, at patienter, der behandles med flupirtinholdige lægemidler, fortsat er eksponeret for alvorlige risici, der opvejer fordelen ved disse lægemidler.
English: • These medicines are being taken off the market in the EU because of a risk of serious liver injury.
Danish: • Disse lægemidler fjernes fra markedet i EU på grund af en risiko for alvorlig leverskade.
English: • Restrictions introduced in 2013, which included limiting flupirtine use to two weeks and regular monitoring of liver function tests, have not been sufficiently followed in clinical practice.
Danish: • De restriktioner, der blev indført i 2013, og som omfattede begrænsning af flupirtinbrug til to uger og regelmæssig overvågning af leverfunktionen, er ikke blevet overholdt i tilstrækkelig grad i klinisk praksis.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh er ansvarlig for at sikre ensartede sikkerhedsstandarder i hele EU for lægemidler, der godkendes via nationale procedurer.
English: The CMDh agreed with the PRAC conclusion that the restrictions introduced in 2013 have not been sufficiently followed, and cases of serious liver injury, including liver failure, still occurred.
Danish: CMDh var enig i PRAC's konklusion om, at restriktionerne fra 2013 ikke var blevet overholdt i tilstrækkelig grad, og at der stadig sås tilfælde af alvorlig leverskade, herunder leversvigt.
English: The review, carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), looked at the available data including studies evaluating whether the 2013 restrictions were followed in clinical practice.
Danish: Gennemgangen, der blev udført af EMA's udvalg for risikovurdering inden for lægemiddelovervågning (PRAC), undersøgte de tilgængelige data, herunder undersøgelser af, om de restriktioner, der blev vedtaget i 2013, var blevet overholdt i klinisk praksis.
English: The CMDh1 has endorsed EMA's recommendation to withdraw the marketing authorisation for the pain medicine flupirtine, because of the risk of serious liver injury.
Danish: CMDh1 har vedtaget at støtte EMA's anbefaling om at tilbagekalde markedsføringstilladelsen for smertemedicinen flupirtin på grund af risikoen for alvorlig leverskade.