FrancophonIA/ELRC3.0 huggingface dataset:
English: In both studies, the effectiveness was measured by looking at how the liver damage had evolved after 48 weeks of treatment using a liver biopsy (when a sample of liver tissue is taken and examined under a microscope).
Danish: I begge undersøgelser blev virkningen målt ved, at man efter 48 ugers behandling ved hjælp af en leverbiopsi (hvor en prøve af levervævet udtages og undersøges under mikroskop) undersøgte, hvordan leverbeskadigelsen havde udviklet sig.
English: Hepsera must not be used in people who are hypersensitive (allergic) to adefovir dipivoxil or any of the other ingredients.
Danish: Hepsera må ikke anvendes af patienter, der er overfølsomme (allergiske) over for adefovirdipivoxil eller andre af indholdsstofferne.
English: For the full list of all side effects reported with Hepsera, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Hepsera fremgår af indlægssedlen.
English: These should be monitored every six months.
Danish: Patientens tilstand samt respons på behandlingen bør undersøges hver sjette måned.
English: What is Hepsera used for?
Danish: Hvad anvendes Hepsera til?
English: How has Hepsera been studied?
Danish: Hvordan blev Hepsera undersøgt?
English: Adefovir is an antiviral belonging to the class ‘nucleoside analogues'.
Danish: Adefovir tilhører en gruppe af antivirale stoffer, der kaldes nukleotidanaloger.
English: How is Hepsera used?
Danish: Hvordan anvendes Hepsera?
English: What benefit has Hepsera shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Hepsera?
English: How does Hepsera work?
Danish: Hvordan virker Hepsera?
English: In conclusion, CVMP is of the opinion that:
Danish: Som konklusion er det CVMP's opfattelse, at:
English: The procedure started on 13 March
Danish: Proceduren blev indledt den 13. marts
English: This procedure started on 21 August 2006 and ended on 20 October 2006.
Danish: Denne procedure blev indledt den 21. august 2006 og afsluttet den 20. oktober 2006.
English: The initial mutual recognition procedure was finalised on 24 June 1999, and 11 other Member States authorised the product at this time.
Danish: Den oprindelige gensidige anerkendelsesprocedure blev afsluttet den 24. juni 1999, og 11 andre medlemsstater godkendte på dette tidspunkt produktet.
English: The first renewal procedure for the vaccine was finalised in June 2004.
Danish: Den første fornyelse for vaccinen blev afsluttet i juni 2004.
English: Member State Applicant or Marketing Authorisation Holder
Danish: Medlemsstat Ansøger eller indehaver af markedsføringstilladelse
English: 7.e.13 Hungary
Danish: 7.e.13 Ungarn
English: Therefore the Danish testing requirement is considered to be unjustified.
Danish: Det danske krav om testning anses derfor for ubegrundet.
English: One dose = 2 ml
Danish: Én dosis = 2 ml
English: CY-1665 Nicosia Cyprus
Danish: CY-1665 Nicosia Cypern
English: In March 2006 Intervet then submitted an application for a marketing authorisation for this vaccine following a repeat use mutual recognition procedure, with Germany acting as Reference Member State, for Denmark, Poland, Slovakia and Slovenia.
Danish: I marts 2006 indgav Intervet herefter en ansøgning om markedsføringstilladelse for vaccinen ved gentagelse af den gensidige anerkendelsesprocedure med Tyskland som referencemedlemsstat for Danmark, Polen, Slovakiet og Slovenien.
English: Based on the current requirements and the relevant safeguards (e.g., GMP) the CVMP concludes that the Applicant has taken adequate measures to guarantee the quality and safety of Bovilis BVD.
Danish: Baseret på de aktuelle krav og de relevante sikkerhedsforanstaltninger (f.eks. GMP) konkluderer CVMP, at ansøgeren har truffet tilstrækkelige foranstaltninger til at garantere kvaliteten og sikkerheden af Bovilis BVD.
English: The factors which determine the safety of a product are the measures applied in the production and control procedures.
Danish: De afgørende faktorer for et produkts sikkerhed er de foranstaltninger, der træffes i produktionen, samt kontrolprocedurerne.
English: There is always a small risk of extraneous agent contamination from a variety of sources.
Danish: Der vil altid være en lille risiko for kontaminering med fremmede agenser fra en række forskellige kilder.
English: DK-2740 Skovlunde Denmark
Danish: DK-2740 Skovlunde Danmark
English: It is worthy of note that the first EU marketing authorisation for Bovilis BVD was granted in 1998, and the vaccine is currently authorised in 14 EU Member States.
Danish: Det er værd at bemærke, at den første EU-markedsføringstilladelse for Bovilis BVD blev udstedt i 1998, og at vaccinen aktuelt er godkendt i 14 EU-medlemsstater.
English: 50 ELISA units, inducing ≥ 4.6 log2 VN units
Danish: 50 ELISAenheder, der inducerer ≥ 4,6 log2 VN-enheder
English: monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
Danish: monografier for inaktiverede bovine vacciner og har skriftligt anmodet EDQM om at tage dette punkt op.
English: CVMP have noted the inconsistencies (with regard to extraneous agents testing) in the Ph.Eur.
Danish: CVMP har konstateret uoverensstemmelser (hvad angår testning for fremmede agenser) i Ph.Eur's.
English: CZ-155 21 Prague 5
Danish: CZ-155 21 Prague 5 Tjekkiet
English: Bovilis BVD was first authorised in Germany on 6 May 1998 (as Bovilis BVD-MD).
Danish: Bovilis BVD blev første gang godkendt i Tyskland den 6 .maj 1998 (som Bovilis BVD-MD).
English: On the contrary it is known that extremely high numbers of samples must be tested in order to detect a low level of defects.
Danish: Derimod vides det, at der må testes et ekstremt stort antal prøver for at detektere fejl, der forekommer i lavt omfang.
English: SI-1000 Ljubljana Slovenija
Danish: SI-1000 Ljubljana Slovenien
English: The extra testing (which requires the use of animals) would therefore be a disproportionate measure when balanced against the positive effects which can be obtained for this vaccine.
Danish: Den pågældende ekstra testning (som kræver brug af dyr) vil derfor være en uforholdsmæssig foranstaltning i forhold til de positive virkninger, der kan opnås med vaccinen.
English: BLV and IBRV are more ubiquitous but the measures summarised below have generally been accepted in the majority of member states to be adequate to ensure negligible risk.
Danish: BLV og IBRV er mere almindeligt forekommende, men de nedenfor opførte foranstaltninger er i størstedelen af medlemsstaterne generelt blevet godtaget som tilstrækkelige til at sikre, at risikoen er ubetydelig.
English: At day 90 of the MRP, 2 August 2006, Denmark could not agree to the granting of a marketing authorization as they considered the product to present a potential serious risk for animal health.
Danish: På dag 90 af den gensidige anerkendelsesprocedure, den 2. august 2006, kunne Danmark ikke tilslutte sig udstedelse af en markedsføringstilladelse, da produktet blev anset for at udgøre en alvorlig risiko for dyrs sundhed.
English: Consequently Germany notified the EMEA, on 31 October 2006, that the CMD(v) failed to reach an agreement regarding Bovilis BVD.
Danish: Tyskland underrettede følgelig den 31. oktober 2006 EMEA om, at CMD(v) ikke var nået til enighed om Bovilis BVD.
English: • extraneous agents testing of raw materials are carried out according to the relevant requirements
Danish: • råmaterialerne testes for fremmede agenser i overensstemmelse med de pågældende krav
English: B-2800 Mechelen Belgium
Danish: B-2800 Mechelen Belgien
English: The CMD(v) could not reach an agreement by day 60 of this procedure, as to where Denmark maintained their concerns.
Danish: CMD(v) havde på dag 60 af proceduren ikke kunnet nå til enighed vedrørende de af Danmark fastholdte betænkeligheder.
English: The production and testing of Bovilis BVD vaccine are in accordance with the relevant requirements of Directive 2001/82/EC, the relevant EU guidelines and the relevant monographs of the Ph.Eur.
Danish: Bovilis BVD-vaccine produceres og testes i overensstemmelse med de pågældende krav i direktiv 2001/82/EF, de pågældende EU-retningslinjer og de pågældende monografier i Ph.Eur.
English: ES-37080 Salamanca Spain
Danish: ES-37080 Salamanca Spanien
English: The Marketing Authorisation Holder should provide all supporting data to justify a positive benefit-risk ratio for the treated animal.
Danish: Indehaveren af markedsføringstilladelsen skulle forelægge alle oplysninger, der begrunder, at risk-benefit forholdet for den behandlede dyreart er positivt.
English: No scientific arguments are available concerning how the additional testing would minimise the risk of possible seroconversion induced by the vaccine.
Danish: Der foreligger ingen videnskabelige beviser for, i hvilket omfang supplerende testning vil minimere risikoen for eventuel serokonvertering fremkaldt af vaccinen.
English: Foot and Mouth virus is virtually exotic to Western Europe and Bluetongue, although of a recent change in status, is not ubiquitous or endemic in the majority of the EU, so for these 2 agents the practical risks should be lower.
Danish: Mund- og klovsygevirus er praktisk talt eksotisk i Vesteuropa, og skønt blå tunge for nylig har ændret status, er denne sygdom ikke almindeligt forekommende eller endemisk i størstedelen af EU, således risikoen i praksis skulle være mindre for disse to agenser.
English: DE-85716 Unterschleissheim Germany
Danish: DE-85716 Unterschleissheim Tyskland
English: There are many years of experience with the use of this vaccine, and there are no known adverse reactions associated with the vaccine.
Danish: Der er mange års erfaring med brug af vaccinen, og der er ingen kendte bivirkninger forbundet med den.
English: The CVMP has concluded that the risk/benefit for Bovilis BVD is favourable.
Danish: CVMP konkluderede, at benefit/risk forholdet for Bovilis BVD er gunstigt.
English: • the production of Bovilis BVD vaccine is in compliance with GMP requirements
Danish: • produktionen af Bovilis BVD-vaccine er i overensstemmelse med GMP-krav
English: Wybrzeze Gdynskie 6c PL-01-531 Warszawa Poland
Danish: Wybrzeze Gdynskie 6c PL-01-531 Warszawa Polen
English: FR-49071 Beaucouzé Cedex France
Danish: FR-49071 Beaucouzé Cedex Frankrig
English: The added value of retesting for this feature in inactivated viral vaccines is extremely small.
Danish: Den ekstra fordel ved at udføre kontroltest for denne egenskab i vacciner med inaktiveret virus er yderst lille.
English: Intervet Bulgaria EOOD 7, Iskarsko shoes blvd BG-1528 Sofia Bulgaria
Danish: Intervet Bulgaria EOOD 7, Iskarsko shoes blvd BG-1528 Sofia Bulgarien
English: Per 2 ml dose:
Danish: Én dosis a 2 ml indeholder:
English: (Immunisation schedules are given in the product information.)
Danish: (Vaccinationsplanen fremgår af produktresuméet.)
English: Considering all the measures taken, it is very unlikely that any contamination of Bovilis BVD could firstly occur, and secondly that such contamination would eventually lead to seroconversion, even in a small number of vaccinated animals.
Danish: I betragtning af alle de trufne foranstaltninger er der meget ringe sandsynlighed for det første for, at kontaminering af Bovilis BVD vil forekomme, og for det andet for, at en sådan kontaminering i sidste instans vil føre til serokonvertering af blot et lille antal vaccinerede dyr.
English: The benefits of Bovilis BVD vaccine are accepted.
Danish: Fordelene ved Bovilis BVD vaccine godtages.
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), for a 60 day procedure in accordance with Article 33(1) of Directive 2001/82/EC, as amended.
Danish: Sagen blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer, (CMD(v)), med henblik på en 60 dages procedure i henhold til artikel 33, stk. 1, i direktiv 2001/82/EF, med senere ændringer.
English: With regard to the potential benefit or otherwise from conducting additional tests, it is known that the efficiency of final batch testing in revealing defects is highly variable, depending on the type of defect, and that it is preferable to build quality into the whole process rather than rely on end product testing.
Danish: Vedrørende den mulige fordel eller ulempe ved at foretage supplerende test vides, at effektiviteten af batchtestning af det færdige præparat med henblik på afsløring af fejl afhænger stærkt af fejlens art, og at det må foretrækkes at indbygge kvaliteten i processen frem for at forlade sig på testning af det færdige præparat.
English: Therefore the requested additional specified extraneous testing requirement is scientifically not justified for Bovilis BVD.
Danish: Den anmodede supplerende specificerede prøvning for fremmede agenser er derfor ikke fagligt begrundet for Bovilis BVD.
English: Denmark considers that the proposed testing regime to demonstrate freedom from extraneous agents is insufficient to ensure that Bovilis BVD would not interfere with their national eradication campaigns for certain animal diseases and that therefore the benefit: risk assessment for Bovilis BVD is negative and authorisation of the product would represent a potential serious risk to animal health.
Danish: Denmark finder, at det påtænkte testprogram til påvisning af fravær af fremmede agenser er utilstrækkeligt til at sikre, at Bovilis BVD ikke vil gribe ind i landets nationale program til udryddelse af visse sygdomme hos dyr, og at benefit/risk forholdet for Bovilis BVD derfor er negativt, således at godkendelse af produktet vil udgøre en potentiel alvorlig risiko for dyrs sundhed.
English: IT-20068 Peschiera Borromeo - Milano
Danish: IT-20068 Peschiera BorromeoMilano
English: The risk of accidental contamination with FMDV, IBRV, BLV and BTV is concluded to be low; consequently the risk of seroconversion against the listed agents is also concluded to be low.
Danish: Det konkluderes, at der er lav risiko for accidentel kontaminering med FMDV, IBRV, BLV og BTV, og dermed også lav risiko for serokonvertering over for de anførte agenser.
English: Belgium Intervet Belgium Bedrijvenlaan 7
Danish: Intervet Belgium Bedrijvenlaan 7
English: Cattle Intramuscular injection.
Danish: Intramuskulær injektion
English: Although the consequences of an accidental seroconversion against the listed extraneous agents would damage the animal health status of a country free from the four specified diseases, the benefit: risk evaluation remains positive due to the low risk of contamination of the product.
Danish: Skønt en accidentel serokonvertering over de opførte fremmede agenser ville få skadelige konsekvenser for dyresundhedsstatus i en stat, hvor de fire anførte sygdomme ikke forekommer, anses risk-benefit forholdet fortsat for at være positivt på grund af den lave risiko for kontaminering af produktet.
English: As the likelihood of contamination of Bovilis BVD vaccine, and the subsequent probability of seroconversion by such contaminants is extremely low, the advantage of additional final product testing for extraneous agents (serological method) is considered to be negligible.
Danish: Da der er ekstremt ringe sandsynlighed for kontaminering af Bovilis BVD vaccine eller for en efterfølgende serokonvertering forårsaget af sådanne kontaminanter, findes der kun at være ubetydelig fordel ved yderligere testning af det færdige præparat for fremmede agenser (med en serologisk metode).
English: 3, Paparigopoulou Street GR-152 32 Halandri Athens Greece
Danish: Grækenland Intervet Hellas S.A. 3, Paparigopoulou Street GR-152 32 Halandri Athens Grækenland
English: During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Bovilis BVD.
Danish: CVMP indledte på sit møde i november 2006 en indbringelsesprocedure for Bovilis BVD i overensstemmelse med artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer.
English: The probability that any such contamination would be identified in the test proposed by the Danish Medicines Agency is even smaller.
Danish: Sandsynligheden er endnu ringere for, at en sådan eventuel konvertering vil kunne påvises med den test, der foreslås af den danske lægemiddelstyrelse.
English: • extraneous agents testing of finished batches of Bovilis BVD for FMDV, BLV, BTV and IBRV is not required in the relevant monographs
Danish: • de pågældende monografier indeholder intet krav om testning af batcher af det færdige præparat af Bovilis BVD for FMDV, BLV, BTV eller IBRV
English: In general, the absence of extraneous agents in vaccines can be ensured by: GMP compliance of the production system Extraneous agents testing of raw materials Extraneous agents testing of batches of finished product, if required.
Danish: Generelt kan fravær af fremmede agenser i vacciner sikres ved følgende foranstaltninger: Overholdelse af GMP i produktionssystemet
English: Intervet International B.V. Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands Tel: + 31 485 587 652
Danish: NL-5831 AN Boxmeer Nederlandene
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter has been referred to CVMP.
Danish: Sagen blev indbragt for CVMP i overensstemmelse med artikel 33, stk. 4, i Rådets direktiv 2001/82/EF, med senere ændringer.
English: SK-040 01 Kosice Slovak Republic Tel: +421 (55) 676 9405 Fax: +421 (55) 676 9873
Danish: Det Forenede Kongerige Tel: +44 (1908) 665 050 Fax: +44 (1908) 664 778
English: The European Commission granted a marketing authorisation valid throughout the European Union for Telmisartan Actavis on 30 September 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Telmisartan Actavis den 30. september 2010.
English: It is available as tablets (20 mg; 40 and 80 mg).
Danish: Det fås som tabletter (20 mg, 40 mg og 80 mg).
English: This is a summary of the European public assessment report (EPAR) for Telmisartan Actavis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Telmisartan Actavis.
English: Telmisartan Actavis is used to treat essential hypertension (high blood pressure) in adults.
Danish: Telmisartan Actavis anvendes til behandling af essentiel hypertension (højt blodtryk) hos voksne.
English: The doctor should monitor the patient's blood pressure closely when starting Telmisartan Actavis, and may decide to adjust the patient's blood pressure-lowering medication.
Danish: Lægen skal overvåge patientens blodtryk nøje, når behandlingen med Telmisartan Actavis påbegyndes, og kan vælge at justere patientens blodtryksnedsættende lægemidler.
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 Telmisartan Actavis.
Danish: Det forklarer, hvordan 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 Telmisartan Actavis skal anvendes.
English: The full EPAR for Telmisartan Actavis can be found on the Agency's website EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Telmisartan Actavis findes på EMA's websted under: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that Telmisartan Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Danish: Det betyder, at Telmisartan Actavis er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Micardis.
English: For more information about treatment with Telmisartan Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Telmisartan Actavis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Telmisartan Actavis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Telmisartan Actavis, telmisartan, er en "angiotensin II-receptorantagonist", hvilket betyder, at det blokerer virkningen af et hormon i kroppen kaldet angiotensin II.
English: For the treatment of essential hypertension, the usual recommended dose of Telmisartan Actavis is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Danish: Til behandling af essentiel hypertension er den sædvanlige anbefalede dosis af Telmisartan Actavis 40 mg én gang dagligt, men visse patienter kan have fordel af 20 mg én gang dagligt.
English: Other information about Telmisartan Actavis:
Danish: Andre oplysninger om Telmisartan Actavis:
English: The Committee recommended that Telmisartan Actavis be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Telmisartan Actavis.
English: The CHMP concluded that, in accordance with EU requirements, Telmisartan Actavis has been shown to have comparable quality and to be bioequivalent to Micardis.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Telmisartan Actavis er af sammenlignelig kvalitet og er bioækvivalent/sammenlignelig med Micardis.
English: pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Danish: Ved utilstrækkelig virkning kan dosis øges til 80 mg, eller Telmisartan Actavis kan anvendes i kombination med et andet lægemiddel for hypertension, for eksempel hydrochlorothiazid.
English: Telmisartan Actavis is a medicine that contains the active substance telmisartan.
Danish: Telmisartan Actavis er et lægemiddel, der indeholder det aktive stof telmisartan.
English: Telmisartan Actavis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Danish: Telmisartan Actavis anvendes også til at forebygge kardiovaskulære problemer (hjerte-kar-problemer), såsom hjerteanfald og slagtilfælde.
English: Because Telmisartan Actavis 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 Telmisartan Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Telmisartan Actavis is a ‘generic medicine'.
Danish: Telmisartan Actavis er et "generisk lægemiddel".
English: Because Telmisartan Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Danish: Da Telmisartan Actavis er et generisk lægemiddel, har personundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Micardis.
English: What are the benefits and risks of Telmisartan Actavis?
Danish: Hvilken fordel og risiko er der forbundet med Telmisartan Actavis?
English: Why has Telmisartan Actavis been approved?
Danish: Hvorfor blev Telmisartan Actavis godkendt?
English: What is Telmisartan Actavis?
Danish: Hvad er Telmisartan Actavis?
English: What is Telmisartan Actavis used for?
Danish: Hvad anvendes Telmisartan Actavis til?
English: How has Telmisartan Actavis been studied?
Danish: Hvordan blev Telmisartan Actavis undersøgt?
English: How is Telmisartan Actavis used?
Danish: Hvordan anvendes Telmisartan Actavis?
English: How does Telmisartan Actavis work?
Danish: Hvordan virker Telmisartan Actavis?
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: MF (EU)-nummer (Særnavn) Navn
English: MA (EU) Number
Danish: Markedsføringstill adelsesnummer (EU)
English: This overview was last updated in March 2019.
Danish: Denne oversigt blev sidst ajourført i marts 2019.