FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mifepristone Linepharma outweigh its risks, and recommended that the marketing authorisation granted in Sweden be recognised in other Member States of the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Mifepriston Linepharma opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Sverige, skal anerkendes i de øvrige EU medlemsstater.
English: Mifepristone Linepharma is a medicine used for terminating pregnancy.
Danish: Mifepriston Linepharma er et lægemiddel, der anvendes til svangerskabsafbrydelse.
English: The grounds for the referral were that Mifepristone Linepharma had not been shown to be bioequivalent to the reference medicine, Mifegyne 200 mg.
Danish: Begrundelsen for indbringelsen var, at Mifepriston Linepharma ikke var påvist at være bioækvivalent med referencelægemidlet, Mifegyne 200 mg.
English: Mifepristone Linepharma is a ‘hybrid medicine'.
Danish: Mifepriston Linepharma er et "hybridt lægemiddel".
English: Therefore, based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Mifepristone Linepharma outweigh its risks and recommended that the marketing authorisation for Mifepristone Linepharma be granted in all concerned Member States.
Danish: Efter vurderingen af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP derfor, at fordelene ved Mifepriston Linepharma opvejer risiciene, og at der bør udstedes markedsføringstilladelse for Mifepriston Linepharma i alle berørte medlemsstater.
English: The CHMP noted that the data submitted by the company showed a small deviation of Mifepristone Linepharma from the acceptable range for bioequivalence with the reference medicine, with Mifepristone Linepharma 200 mg producing slightly higher levels of active substance in the body than Mifegyne 200 mg.
Danish: CHMP konstaterede, at de af virksomheden forelagte oplysninger viste en lille afvigelse af Mifepriston Linepharma fra det acceptable område for bioækvivalens med referencelægemidlet, idet Mifepriston Linepharma, 200 mg, frembragte lidt højere koncentrationer af det aktive stof i kroppen end Mifegyne, 200 mg.
English: Mifepristone Linepharma is given as a single dose of 200 mg, followed 36 - 48 hours later by a dose of another medicine called gemeprost.
Danish: Mifepriston Linepharma gives som en enkelt dosis på 200 mg, hvorpå der efter 36-48 timer gives en dosis af et andet lægemiddel, gemeprost.
English: 28 February 2014
Danish: Den 28. februar 2014
English: The final opinion was converted into a Decision by the European Commission on 28 February 2014.
Danish: Den endelige udtalelse blev den 28. februar 2014 omarbejdet til en beslutning af EuropaKommissionen.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Danish: Det har antibakteriel aktivitet mod et bredt spektrum af gramnegative og grampositive bakterier.
English: The referral started on 7 November 2012.
Danish: Indbringelsesproceduren blev indledt den 7. november 2012.
English: Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Danish: Ansøgerne og indehaverne af markedsføringstilladelserne afgav skriftlige redegørelser den 15. februar 2013 og den 9. september
English: International non-proprietary name (INN): enrofloxacin
Danish: Internationalt fællesnavn (INN): enrofloxacin
English: Veterinary Medicines
Danish: Afdelingen for veterinærlægemidler
English: The condition on the marketing authorisations is in Annex IV.
Danish: Betingelsen for markedsføringstilladelserne fremgår af bilag IV.
English: The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis H. Jukes og E-M. Vestergaard.
English: Enrofloxacin is for veterinary use only.
Danish: Enrofloxacin er udelukkende bestemt til veterinær anvendelse.
English: The CVMP was requested to consider the indications, dosage regimens and withdrawal periods for chickens and turkeys in order to ensure consumer safety, efficacious treatment in chickens and turkeys, as well as lower the risk of development of antimicrobial resistance to enrofloxacin.
Danish: CVMP blev anmodet om at gennemgå indikationer, dosisregimer og tilbageholdelsestider for kyllinger og kalkuner for at opnå sikkerhed for forbrugerne og effektiv behandling af kyllinger og kalkuner og for at mindske risikoen for udvikling af antimikrobiel resistens over for enrofloxacin.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information and conditions of the marketing authorisations.
Danish: På grundlag af de foreliggende data fandt CVMP, at det overordnede benefit/risk-forhold for disse produkter fortsat er positivt, forudsat at der foretages ændringer i produktinformationen og betingelserne for markedsføringstilladelserne.
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Danish: Enrofloxacin er et syntetisk kemoterapeutikum, der tilhører klassen carboxylsyrederivater af fluorquinolon.
English: On 18 October 2012, the United Kingdom presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys.
Danish: Den 18. oktober 2012 anmeldte Det Forenede Kongerige til agenturet en indbringelse i henhold til artikel 35 i direktiv 2001/82/EF vedrørende alle veterinærmedicinske produkter indeholdende enrofloxacin til brug i drikkevandet til kyllinger og/eller kalkuner.
English: Therefore on 7 November 2013 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for all veterinary medicinal products containing enrofloxacin to be administered via drinking water to chickens and/or turkeys.
Danish: Udvalget vedtog derfor den 7. november 2013 enstemmigt en positiv udtalelse, der anbefaler ændringer af markedsføringstilladelserne for alle veterinærmedicinske præparater indeholdende enrofloxacin til brug i drikkevandet til kyllinger og/eller kalkuner.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: 1 bottle, (240 ml)+ 10 ml oral dosing syringe and adapter
Danish: 1 Flaske, (270 ml)+en 10 ml doseringssprøjte af polypropylen og et tilpasningsstykke
English: 240 ml (10 mg/ml)
Danish: Oral anvendelse Flaske (HDPE) 240 ml(10 mg/ml)
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (koncentration)
English: It is used in patients with:
Danish: Det anvendes til patienter med:
English: The duration of treatment depends on the patient's condition and response to treatment.
Danish: Behandlingens varighed afhænger af patientens tilstand og respons på behandlingen.
English: There were several measures of effectiveness in the studies.
Danish: Der var flere forskellige mål for virkningen i undersøgelserne.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zeffix on 29 July 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zeffix den 29. juli 1999.
English: The recommended dose of Zeffix is 100 mg once a day.
Danish: Den anbefalede dosis af Zeffix er 100 mg én gang dagligt.
English: It is available as tablets (100 mg) and an oral solution (5 mg/ml).
Danish: Det fås som tabletter (100 mg) og oral opløsning (5 mg/ml).
English: The full EPAR for Zeffix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zeffix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This document is a summary of the European public assessment report (EPAR) for Zeffix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zeffix.
English: Zeffix lamivudine
Danish: Zeffix lamivudin
English: Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.
Danish: Lamivudin forhindrer virusset i at producere dna og forhindrer derved, at det formerer sig og spredes.
English: • decompensated liver disease (when the liver does not work normally).
Danish: • Dekompenseret leversygdom (hvor leveren er beskadiget, og ikke fungerer normalt).
English: Zeffix was as effective as alfa-interferon.
Danish: Zeffix var lige så effektiv som alfa-interferon.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zeffix.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Zeffix skal anvendes.
English: Doses lower than 100 mg need to be given using the oral solution.
Danish: Doser under 100 mg skal gives ved hjælp af den orale opløsning.
English: In addition, information was presented on the use of Zeffix in patients with decompensated liver disease.
Danish: Desuden blev der fremlagt oplysninger om anvendelsen af Zeffix hos patienter med dekompenseret leversygdom.
English: For more information about treatment with Zeffix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zeffix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • compensated liver disease (when the liver is damaged but works normally), who also show signs that the virus is still multiplying and have signs of liver damage (raised levels of the liver enzyme alanine aminotransferase [ALT] and signs of damage when liver tissue is examined under a microscope).
Danish: • Kompenseret leversygdom (hvor leveren er beskadiget, men fungerer normalt), og hvor der endvidere er tegn på, at virusset stadig formerer sig, og hvor der er tegn på leverbeskadigelse (forhøjede niveauer af leverenzymet "alanin-aminotransferase" [ALAT] samt tegn på beskadigelse, når levervævet undersøges under mikroskop).
English: The dose needs to be lower in patients who have reduced kidney function.
Danish: Dosen skal være mindre til patienter med nedsat nyrefunktion.
English: Zeffix is a medicine that contains the active substance lamivudine.
Danish: Zeffix er et lægemiddel, der indeholder det aktive stof lamivudin.
English: These are patients infected with hepatitis B virus that has mutated (changed), leading to a form of chronic hepatitis B that is more difficult to treat.
Danish: Det er patienter, der er smittet med hepatitis B-virus, som har muteret, dvs. forandret sig, og som har ført til en form for kronisk hepatitis B, der er vanskeligere at behandle.
English: Treatment with Zeffix should be started by a doctor who has experience in the management of chronic hepatitis B.
Danish: Behandlingen med Zeffix bør iværksættes af en læge med erfaring i behandling af kronisk hepatitis B.
English: Lamivudine interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Danish: Lamivudin påvirker virkningsmekanismen for et virus-enzym kaldet dna-polymerase, som medvirker ved dannelsen af virus-dna.
English: The CHMP decided that Zeffix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Zeffix opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Zeffix.
English: The most common side effect with Zeffix (seen in more than 1 patient in 10) is raised ALT levels.
Danish: Den hyppigste bivirkning ved Zeffix (som optræder hos flere end 1 ud af 10 patienter) er forhøjet ALAT-værdi.
English: If the hepatitis B virus can still be found in the blood after six months of treatment, the doctor should consider switching treatment or adding another medicine for hepatitis B to reduce the risk of resistance.
Danish: Hvis der stadig findes hepatitis B-virus i blodet efter seks måneders behandling, skal lægen overveje at skifte til en anden behandling eller tilføje et andet lægemiddel mod hepatitis B for at mindske risikoen for resistens.
English: In patients with compensated liver disease, Zeffix was more effective than placebo in slowing down the progression of liver disease.
Danish: Hos patienter med kompenseret leversygdom var Zeffix mere effektiv end placebo til at hæmme udviklingen af leversygdommen.
English: Zeffix is used to treat adults (aged 18 years or over) who have chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Danish: Zeffix anvendes til behandling af voksne (18 år og derover) med kronisk (langvarig) hepatitis B (en leversygdom, der skyldes en infektion med hepatitis B-virus).
English: Zeffix has been studied in five main studies involving a total of 1,083 adults with compensated liver disease due to chronic hepatitis B. Three studies compared Zeffix with placebo (a dummy treatment), one of which looked particularly at ‘HBeAg-negative' patients.
Danish: Zeffix er blevet undersøgt i fem hovedundersøgelser med i alt 1 083 voksne med kompenseret leversygdom, der skyldes kronisk hepatitis B. I tre af undersøgelserne blev Zeffix sammenlignet med placebo (en uvirksom behandling), herunder en undersøgelse, der mere specifikt undersøgte "HBeAgnegative patienter".
English: To reduce the risk of resistance, Zeffix must be used in combination with another anti-hepatitis B medicine that does not cause resistance in the same way as Zeffix.
Danish: For at mindske risikoen for resistens skal Zeffix anvendes i kombination med andre lægemidler til behandling af hepatitis B, som ikke medfører resistens på samme måde som Zeffix.
English: The active substance in Zeffix, lamivudine, is an antiviral agent that belongs to the class ‘nucleoside analogues'.
Danish: Det aktive stof i Zeffix, lamivudin, er et antiviralt middel, der tilhører gruppen af nukleosidanaloger.
English: Other information about Zeffix:
Danish: Andre oplysninger om Zeffix
English: The other two studies compared Zeffix taken on its own with alfa-interferon (another treatment used in chronic hepatitis B) on its own and with the combination of Zeffix and alfa-interferon.
Danish: De resterende to undersøgelser så nærmere på brugen af Zeffix givet alene sammenlignet med alfainterferon (en anden behandling mod kronisk hepatitis B) givet alene og med kombinationen af Zeffix og alfa-interferon.
English: In patients with decompensated liver disease, Zeffix also reduced levels of hepatitis B virus DNA and ALT.
Danish: Hos patienter med dekompenseret leversygdom reducerede Zeffix også indholdet af hepatitis B-virusdna og ALAT.
English: These included looking at how the liver damage had evolved after a year of treatment using a liver biopsy (when a small sample of liver tissue is taken and examined under a microscope), as well as measuring other signs of the disease such as the levels of ALT or of hepatitis B virus DNA circulating in the blood.
Danish: Blandt andet så man på, hvordan leverskaden havde udviklet sig efter et års behandling ved hjælp af en leverbiopsi (hvor der udtages en lille prøve af levervævet, som undersøges under mikroskop), og man målte andre tegn på sygdommen såsom ALAT-værdien eller indholdet af hepatitis B-virus-dna i blodet.
English: What is the risk associated with Zeffix?
Danish: Hvilken risiko er der forbundet med Zeffix?
English: Why has Zeffix been approved?
Danish: Hvorfor blev Zeffix godkendt?
English: Because the hepatitis B virus can become resistant to Zeffix, the doctor should only consider prescribing Zeffix if other treatments that are less likely to lead to resistance cannot be used;
Danish: Da hepatitis B-virusset kan udvikle resistens over for Zeffix, bør lægen udelukkende overveje ordinering af Zeffix, hvis det ikke er muligt at benytte andre behandlingsformer, som medfører en lavere risiko for resistens.
English: About half of the patients taking Zeffix had an improvement in liver damage assessed in a biopsy, compared with about a quarter of the patients who took placebo.
Danish: Der blev ved hjælp af biopsi påvist en bedring af leverskaden hos cirka halvdelen af de patienter, der blev behandlet med Zeffix, sammenlignet med cirka en fjerdedel af de patienter, der blev behandlet med placebo.
English: What is Zeffix?
Danish: Hvad er Zeffix?
English: For the full list of all side effects or restrictions with Zeffix, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zeffix fremgår af indlægssedlen.
English: What is Zeffix used for?
Danish: Hvad anvendes Zeffix til?
English: How has Zeffix been studied?
Danish: Hvordan blev Zeffix undersøgt?
English: What benefit has Zeffix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zeffix?
English: How is Zeffix used?
Danish: Hvordan anvendes Zeffix?
English: How does Zeffix work?
Danish: Hvordan virker Zeffix?
English: The European Commission granted a marketing authorisation valid throughout the EU for Exforge on 17 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Exforge den 17. januar 2007.
English: The full EPAR for Exforge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Exforge findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Exforge.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Exforge.
English: Exforge is taken by mouth as one tablet once a day with some water.
Danish: Exforge tages oralt som en tablet en gang dagligt med vand.
English: Other information about Exforge
Danish: Andre oplysninger om Exforge
English: Exforge amlodipine / valsartan
Danish: Exforge amlodipin/valsartan
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Exforge.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Exforge skal anvendes.
English: For more information about treatment with Exforge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Exforge, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Exforge's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Exforge opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Exforge.
English: What is the risk associated with Exforge?
Danish: Hvilken risiko er der forbundet med Exforge?
English: The most common side effects with Exforge (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Danish: De hyppigste bivirkninger ved Exforge (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, betændelse i næse og hals (nasopharyngitis), influenza, lavt kaliumindhold i blodet (hypokaliæmi), forskellige former for hævelser (ødemer), træthed, rødmen, kraftesløshed (asteni) og hedeture.
English: The dose of Exforge to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Danish: Den dosis Exforge, der skal anvendes, afhænger af den dosis amlodipin eller valsartan, som patienten fik tidligere.
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Exforge and people taking the separate medicines.
Danish: Virksomheden fremlagde desuden dokumentation for, at blodets indhold af amlodipin og valsartan er den samme hos personer, der får Exforge, som hos dem, der får lægemidlerne hver for sig.
English: Exforge must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Danish: Exforge må ikke anvendes til patienter med svær lever- eller galdeblæresygdom, patienter med visse hjerteproblemer eller patienter med svær hypotension (lavt blodtryk).
English: Exforge must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Danish: Exforge må heller ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension), hos patienter med type 2-diabetes eller patienter med moderat eller svær nyresygdom.
English: Why has Exforge been approved?
Danish: Hvorfor blev Exforge godkendt?
English: Exforge must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Danish: Exforge må ikke anvendes til patienter, der er overfølsomme (allergiske) over for amlodipin eller andre lægemidler i gruppen af "dihydropyridinderivater", valsartan eller andre af indholdsstofferne.
English: For the full list of all side effects reported with Exforge, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Exforge fremgår af indlægssedlen.
English: Exforge is a medicine that contains two active substances, amlodipine and valsartan.
Danish: Exforge er et lægemiddel, der indeholder de to aktive stoffer amlodipin og valsartan.
English: Exforge is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Danish: Exforge anvendes til patienter med essentiel hypertension (forhøjet blodtryk), når blodtrykket ikke kan kontrolleres tilstrækkeligt med amlodipin eller valsartan alene.
English: Exforge contains two active substances, amlodipine and valsartan.
Danish: Exforge indeholder to aktive stoffer, amlodipin og valsartan.
English: What benefit has Exforge shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Exforge?
English: Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.
Danish: Virksomheden fremlagde derfor oplysninger om de to stoffer fra tidligere undersøgelser og faglitteraturen samt fra nye undersøgelser, hvor der blev anvendt en kombination af de to aktive stoffer.
English: What is Exforge used for?
Danish: Hvad anvendes Exforge til?