FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Seebri Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Danish: Det aktive stof i Seebri Breezhaler, glycopyrroniumbromid, er en muskarin receptorantagonist.
English: Seebri Breezhaler (glycopyrronium bromide)
Danish: Seebri Breezhaler (glycopyrroniumbromid)
English: Other information about Seebri Breezhaler
Danish: Andre oplysninger om Seebri Breezhaler
English: Seebri Breezhaler can only be obtained with a prescription.
Danish: Seebri Breezhaler udleveres kun efter recept.
English: What measures are being taken to ensure the safe use of Seebri Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Seebri Breezhaler?
English: Seebri Breezhaler contains the active substance glycopyrronium bromide.
Danish: Seebri Breezhaler indeholder det aktive stof glycopyrroniumbromid.
English: Seebri Breezhaler capsules, which contain a powder for inhalation, are only used with the Seebri Breezhaler inhaler and must not be swallowed.
Danish: De må kun anvendes med Seebri Breezhaler-inhalatoren og må ikke sluges.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Seebri Breezhaler 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 Seebri Breezhaler.
English: What are the risks associated with Seebri Breezhaler?
Danish: Hvilke risici er der forbundet med Seebri Breezhaler?
English: How is Seebri Breezhaler used?
Danish: Hvordan anvendes Seebri Breezhaler?
English: In addition, there were no major safety concerns with Seebri Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Danish: Desuden var der ingen større sikkerhedsproblemer forbundet med Seebri Breezhaler.
English: How does Seebri Breezhaler work?
Danish: Hvordan virker Seebri Breezhaler?
English: What benefits of Seebri Breezhaler have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Seebri Breezhaler?
English: Memantine LEK should be given once a day at the same time every day.
Danish: Memantine LEK bør gives én gang dagligt på samme tidspunkt hver dag.
English: The full EPAR for Memantine LEK can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Memantine LEK findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: To prevent side effects, the dose of Memantine LEK is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Danish: For at undgå bivirkninger øges dosis af Memantine LEK gradvist i løbet af de tre første uger af behandlingen: I den første uge er dosis 5 mg, i den anden uge er den 10 mg, og i den tredje uge er den 15 mg. Fra uge fire og fremover er den anbefalede vedligeholdelsesdosis 20 mg én gang dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine LEK on 22 April 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Memantine LEK den 22. april 2013.
English: This is a summary of the European public assessment report (EPAR) for Memantine LEK.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Memantine LEK.
English: The Committee recommended that Memantine LEK be approved for use in the EU.
Danish: Udvalget anbefalede, at Memantine LEK godkendes til anvendelse i EU.
English: This means that Memantine LEK is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Danish: Det betyder, at Memantine LEK er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Ebixa.
English: Memantine LEK is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Danish: Memantine LEK er et lægemiddel til behandling af patienter med moderat til svær Alzheimers sygdom, dvs. en type demens (en hjernesygdom), der gradvis påvirker hukommelse, intellektuelle evner og adfærd.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Memantine LEK should be reassessed on a regular basis.
Danish: Tolerance og dosis bør vurderes inden for 3 måneder efter behandlingens start, og herefter bør fordelene ved at fortsætte behandlingen med Memantine LEK regelmæssigt genvurderes.
English: Memantine LEK is a ‘generic medicine'.
Danish: Memantine LEK er et "generisk lægemiddel".
English: What measures are being taken to ensure the safe and effective use of Memantine LEK?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Memantine LEK?
English: Memantine LEK is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Danish: Memantine LEK fås som tabletter (10 mg og 20 mg) og udleveres kun efter recept.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine LEK has been shown to have comparable quality and to be bioequivalent to Axura.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Memantine LEK er af sammenlignelig kvalitet og er bioækvivalent med Axura.
English: Other information about Memantine LEK
Danish: Andre oplysninger om Memantine LEK
English: Safety information has been included in the summary of product characteristics and the package leaflet for Memantine LEK, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Memantine LEK, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: The active substance in Memantine LEK, memantine, is an antidementia medicine.
Danish: Det aktive stof i Memantine LEK, memantin, er et lægemiddel mod demens.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine LEK by the patient.
Danish: Behandlingen bør kun iværksættes, hvis en omsorgsgivende person regelmæssigt overvåger patientens indtagelse af Memantine LEK.
English: What are the benefits and risks of Memantine LEK?
Danish: Hvilke fordele og risici er der forbundet med Memantine LEK?
English: Therefore, the CHMP's view was that, as for Axura, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Axura.
English: For more information about treatment with Memantine LEK, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Memantine LEK, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Memantine LEK and what is it used for?
Danish: Hvad er Memantine LEK, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Memantine LEK.
Danish: Det er ikke en praktisk vejledning i, hvordan Memantine LEK bør anvendes.
English: Because Memantine LEK 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 Memantine LEK er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Memantine LEK is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Axura.
Danish: Da Memantine LEK er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Axura.
English: Why is Memantine LEK approved?
Danish: Hvorfor er Memantine LEK blevet godkendt?
English: For practical information about using Memantine LEK, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Memantine LEK, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Memantine LEK used?
Danish: Hvordan anvendes Memantine LEK?
English: How has Memantine LEK been studied?
Danish: Hvordan er Memantine LEK blevet undersøgt?
English: How does Memantine LEK work?
Danish: Hvordan virker Memantine LEK?
English: 1 bottle + 1 adapter + 1 oral applicator
Danish: 1 beholder + 1 adapter + 1 oral applikator
English: MA (EU) number
Danish: MA (EU) nummer
English: Content (concentration) Package size
Danish: Indhold (koncentration)
English: 20 mg/ml
Danish: Styrke mg/ml
English: Oral solution bottle (HDPE) 230 ml
Danish: Beholder (HDPE/alu) Beholder (HDPE/alu) Beholder (HDPE)
English: (Invented) name Strength Pharmaceutical Form
Danish: Lægemiddelform
English: In addition, patients should be advised to contact their doctor if they have ever been infected with HBV as close monitoring is required.
Danish: Derudover skal patienter rådgives om at kontakte sin læge, hvis vedkommende nogensinde har været inficeret med HBV, da tæt monitorering
English: The RMP should be updated accordingly within 3 months of this CHMP opinion.
Danish: Risikostyringsplanen skal opdateres i overensstemmelse hermed inden for 3 måneder af denne CHMP
English: The RMP of the relevant medicinal products will be updated accordingly.
Danish: Risikostyringsplanen (RMP) for de relevante lægemidler skal opdateres i overensstemmelse
English: CHMP opinion and detailed explanation of the scientific grounds for the differences from the
Danish: CHMP's udtalelse og detaljerede redegørelse for den videnskabelige begrundelse for
English: Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions
Danish: Efter gennemgang af PRAC's anbefaling tilsluttede CHMP sig anbefalingens overordnede videnskabelige
English: Some of the cases identified with DAAs had serious outcomes, with worsening of hepatic status and at least one case where the patient
Danish: Nogle af de tilfælde, der blev identificeret med DAA'er, havde alvorlige konsekvenser med forværring af leverstatus og mindst ét tilfælde, hvor patienten måtte indstilles til levertransplantation.
English: As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use (CHMP) on the basis of a recommendation of the Pharmacovigilance
Danish: Da begge anmodninger for den påbegyndte procedure bunder i en gennemgang af data fra lægemiddelovervågningsaktiviteter, har Kommissionen udbedt sig, at udtalelsen vedtages af Udvalget for Lægemidler til Mennesker (CHMP) på grundlag af en anbefaling fra Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: Should the use of existing data sources not show feasible, a proposal for a prospective collection of data should be provided.
Danish: Skulle brugen af eksisterende datakilder vise sig uhensigtsmæssig, skal der i forundersøgelsen indarbejdes et forslag til
English: The product information will include a warning to inform about the risk of hepatitis B reactivation and
Danish: Produktinformationen vil inkludere en advarsel om, at informere om risikoen for hepatitis B-reaktivering og vil afspejle disse anbefalinger.
English: The European Commission therefore extended the scope of the procedure in April 2016 to allow consideration of other data to assess the risk of hepatocellular carcinoma and its impact on the benefit-risk balance for all DAAs in the treatment of chronic hepatitis C.
Danish: Europa-Kommissionen udvidede derfor omfanget af proceduren i april 2016 af hensyntagen til andre data til vurdering risikoen for hepatocellulært carcinom og carcinomets indvirkning på benefit/risk-forholdet for alle DAA'er i behandlingen af kronisk
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the
Danish: • PRAC fandt, at proceduren i henhold til artikel 20 i forordning (EF) nr. 726/2004, der var foranlediget af lægemiddelovervågningsdata om direkte aktive antivirale lægemidler (DAA'er) indiceret til behandling af kronisk hepatitis C.
English: The current referral procedure was triggered by the European Commission (EC) to allow further investigation of the risk of hepatitis B virus replication after starting treatment with DAAs and recommend any appropriate measure to
Danish: Den aktuelle procedure for indbringelse af sager blev iværksat af Europa-Kommissionen for at muliggøre en nærmere undersøgelse af risikoen for hepatitis B-virus-replikation efter behandlingsstart med DAA'er og anbefale eventuelle relevante risikominimerende tiltag.
English: Generally, the reactivation occurred shortly after the initiation of treatment in a pattern that implies a correlation with the rapid decrease in HCV viral load which characterises the viral load dynamics with DAAs.
Danish: Reaktiveringen forekom generelt kort tid efter behandlingsstart i et mønster, der antyder en forbindelse med det hurtige fald i HCV-virusbyrden, som karakteriserer virusbyrdens dynamik med
English: Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk
Danish: PRAC fandt generelt, at der foreligger bevis for risiko for HBV-reaktivering hos HBV/HCV co-inficerede patienter behandlet med DAA'er, og at HBV-reaktivering hos co-inficerede patienter derfor skal betragtes som en vigtig, identificeret risiko, som skal monitoreres tæt gennem rutinemæssige
English: • The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral
Danish: • PRAC gennemgik alle indsendte skriftlige data og mundtlige forklaringer fra indehaverne af markedsføringstilladelserne med hensyn til risikoen for hepatitis B-reaktivering og de betænkeligheder dette gav anledning til efter rapporter om hepatocellulært carcinom hos patienter, der bruger DAA'er, samt resultaterne fra mødet, der blev afholdt af den videnskabelige rådgivende gruppe, om hiv-/virussygdomme.
English: In accordance with the PRAC recommendation, in order to evaluate the recurrence of hepatocellular carcinoma associated with direct-acting antivirals, the MAHs shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and
Danish: I overensstemmelse med anbefalingen fra PRAC skal indehaverne af markedsføringstilladelserne, for at kunne vurdere recidiv af hepatocellulært carcinom i forbindelse med direkte aktive antivirale lægemidler, gennemføre og indsende resultaterne af en prospektiv sikkerhedsundersøgelse ved brug af data fra en kohorte bestående af en veldefineret patientgruppe, baseret på en i fællesskab vedtaget protokol med kriterier for inkludering og opfølgning af patienter med hensyn til screeningstidspunkt og
English: Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested
Danish: 2016), der blev gennemført i perioden oktober 2014 til december 2015 på hepatologiafdelinger på fire spanske universitetshospitaler hos patienter med kronisk hepatitis C, og hvis anamnese inkluderede hepatocellulært carcinom (HCC), og som var behandlet med DAA'er, et uventet, tidligt recidiv af HCC.
English: In view of the above, the PRAC considers that the benefit-risk balance of direct-acting antivirals remains favourable subject to the amendments to the terms of the marketing authorisations.
Danish: På grundlag af ovenstående konkluderer PRAC, at benefit/risk-forholdet for direkte aktive antivirale lægemidler fortsat er positivt under forudsætning af, at de foreslåede ændringer indføres i
English: EU/1/17/1226/001 LUTATHERA 370 MBq/ml
Danish: EU/1/17/1226/001 LUTATHERA
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: 1 ml (100 mg/ml) 1 pre-filled pen
Danish: 1 ml (100 mg/ml) 1 fyldt pen
English: 1 ml (100 mg/ml) 3 (3 x 1) prefilled pens (multipack)
Danish: 1 ml (100 mg/ml) 3 (3 x 1) fyldte penne (multipakning)
English: 1 ml (100 mg/ml) 3 (3 x 1) prefilled syringes (multipack)
Danish: 1 ml (100 mg/ml) 3 (3 x 1) fyldte sprøjter (multipakning)
English: 1 ml (100 mg/ml) 1 pre-filled syringe
Danish: 1 ml (100 mg/ml) 1 fyldt sprøjte
English: 23 May 2013
Danish: Den 23. maj 2013
English: International non-proprietary name (INN): florfenicol
Danish: Internationalt fællesnavn (INN): florfenicol
English: The opinion was converted into a Decision by the European Commission on 23 May 2013.
Danish: Udtalelsen blev den 23. maj 2013 omarbejdet til en afgørelse af Europa-Kommissionen.
English: Written explanations were provided by the applicant on 11 September 2012 and 9 January 2013.
Danish: Ansøgeren fremsendte skriftlige redegørelser den 11. september 2012 og den 9. januar 2013.
English: The decentralised procedure started on 17 December 2010.
Danish: Den decentrale procedure blev indledt den 17. december 2010.
English: The Committee appointed Prof. Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis prof. Christian Friis og dr. Cornelia Ibrahim.
English: Oral explanations were given on 5 March 2013.
Danish: Mundtlige redegørelser blev afgivet den 5. marts 2013.
English: Day 60 of the CMD(v) procedure was on 19 April 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Danish: Dag 60 af proceduren i CMD(v) var den 19. april 2012, og da de berørte medlemsstater ikke var i stand til at nå til enighed vedrørende produktet, blev proceduren indbragt for CVMP.
English: Potential serious risks were identified during the decentralised procedure by Denmark regarding the efficacy of the product and the potential for development of antimicrobial resistance to florfenicol.
Danish: Under den decentrale procedure påpegede Danmark potentielle alvorlige risici vedrørende produktets virkning og potentialet for udvikling af antimikrobiel resistens over for florfenicol.
English: Florgane 300 mg/ml suspension for injection has been authorised for use in cattle as a hybrid of Nuflor 300 mg/ml solution for injection using the decentralised procedure (DE/V/0132/001/DC) with Germany as a reference Member State and Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxemburg, the Netherlands, Poland, Portugal, Romania, Slovakia, Spain and the United Kingdom as concerned Member States.
Danish: Florgane, injektionsvæske, suspension, 300 mg/ml, er som hybrid til Nuflor, injektionsvæske, opløsning, 300 mg/ml, godkendt til anvendelse hos kvæg ved den decentrale procedure (DE/V/0132/001/DC) med Tyskland som referencemedlemsstat og Østrig, Belgien, Bulgarien, Tjekkiet, Danmark, Frankrig, Grækenland, Ungarn, Irland, Italien, Litauen, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Spanien og Det Forenede Kongerige som berørte medlemsstater.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 20 February 2012.
Danish: På dag 210 var disse spørgsmål fortsat uafklarede, hvorfor sagen den 20. februar 2012 i henhold til artikel 33, stk. 1, i direktiv 2001/82/EF blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - veterinær (CMD(v)).
English: This extension application (DE/V/0132/001/DX/001) was submitted according to the same procedure (DCP) and type of application (hybrid, according to Article 13(3) of Directive 2001/82/EC) as for the initial application for cattle, to the same Member States.
Danish: Denne udvidelsesansøgning (DE/V/0132/001/DX/001) blev indgivet ved den decentrale procedure som en hybrid ansøgning i henhold til artikel 13, stk. 3, i direktiv 2001/82/EF ligesom den oprindelige ansøgning for kvæg til samme medlemsstater.
English: The proposed dose is 22.5 mg florfenicol per kg bodyweight given by intramuscular administration as a single injection.
Danish: Den ansøgte dosis er 22,5 mg florfenicol/kg kropsvægt, givet som en enkelt intramuskulær injektion.
English: The referral procedure started on 15 May 2012.
Danish: Indbringelsesproceduren blev indledt den 15. maj 2012.
English: On 19 April 2012, the reference Member State, Germany, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Danish: Den 19. april 2012 underrettede referencemedlemsstaten, Tyskland, Det Europæiske Lægemiddelagentur om, at CMD(v) ikke havde været i stand til at nå til enighed vedrørende produktet, og indbragte sagen for CVMP i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
English: The reference product was Nuflor Swine Injectable Solution 300 mg/ml (FR/V/0118/001).
Danish: Referenceproduktet var Nuflor Swine, injektionsvæske, opløsning, 300 mg/ml (FR/V/0118/001).
English: Florgane 300 mg/ml suspension for injection for cattle and pigs contains florfenicol as active ingredient and is intended for use in pigs for the treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Danish: Florgane, injektionsvæske, suspension, 300 mg/ml, til kvæg og svin, indeholder florfenicol som aktivt stof og er bestemt til behandling af svin ved akutte udbrud af luftvejssygdom forårsaget af florfenicolfølsomme stammer af Actinobacillus pleuropneumoniae og Pasteurella multocida.
English: Opinion following an Article 33(4)0F referral for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names EMA/324042/2013
Danish: Udtalelse efter en indbringelse i henhold til artikel 33, stk. 40F for Florgane, injektionsvæske, suspension, til kvæg og svin, og relaterede navne EMA/324042/2013
English: The applicant, Emdoka bvba, submitted an application for a decentralised procedure for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Danish: Ansøgeren, Emdoka bvba, har indgivet en ansøgning via den decentrale procedure for Florgane, injektionsvæske, suspension, 300 mg/ml, til kvæg og svin, og relaterede navne.