FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults, it can also be used for those patients with liver damage whose liver does not work properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).
Danish: Hos voksne kan det også anvendes til patienter, hvis lever er beskadiget og ikke fungerer (dekompenseret leversygdom), og patienter, som ikke reagerer på behandling med lamivudin (et andet lægemiddel mod hepatitis B).
English: In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Danish: Ved hivinfektion blokerer det aktiviteten af revers transkriptase, et enzym, der produceres af hiv, og som gør det muligt for hiv at inficere cellerne og producere flere virus.
English: Tenofovir disoproxil Zentiva is available as tablets (245 mg) to be taken by mouth.
Danish: Tenofovir disoproxil Zentiva fås som tabletter (245 mg), der tages gennem munden.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tenofovir disoproxil Zentiva has been shown to have comparable quality and to be bioequivalent to Viread.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Tenofovir disoproxil Zentiva er af sammenlignelig kvalitet og er bioækvivalent med Viread.
English: Tenofovir disoproxil Zentiva is used in combination with other HIV medicines.
Danish: Tenofovir disoproxil Zentiva anvendes i kombination med andre lægemidler mod hiv.
English: The company that markets Tenofovir disoproxil Zentiva will ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Danish: Virksomheden, der markedsfører Tenofovir disoproxil Zentiva, skal sikre, at alle læger, som forventes at ordinere eller anvende lægemidlet, får udleveret informationsmateriale, der indeholder sikkerhedsoplysninger, navnlig om risici og forholdsregler med hensyn til nyrefunktion og knogler.
English: Tenofovir disoproxil Zentiva stops the virus making DNA and prevents it from multiplying and spreading.
Danish: Tenofovir disoproxil Zentiva forhindrer virusset i at producere dna og forhindrer derved, at det formerer sig og spredes.
English: Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Danish: Tenofovir disoproxil Zentiva helbreder ikke hivinfektion eller aids, men kan holde skader på immunsystemet på afstand og forhindre de infektioner og sygdomme, der er forbundet med aids.
English: Tenofovir disoproxil Zentiva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Tenofovir disoproxil Zentiva tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Zentiva once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.
Danish: For så vidt angår patienter, der tidligere har fået lægemidler mod hivinfektion, skal lægen inden ordinering af Tenofovir disoproxil Zentiva gennemgå de antivirale lægemidler, patienten tidligere har fået, og vurdere sandsynligheden for, at virusset reagerer på antivirale lægemidler.
English: Tenofovir disoproxil Zentiva can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B.
Danish: Tenofovir disoproxil Zentiva udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af hivinfektion eller kronisk hepatitis B.
English: In adolescents (from 12 to 18 years of age) its use is only for those who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI).
Danish: Hos unge i alderen 12-18 år anvendes det kun, hvis de ikke kan behandles med andre revers transkriptase-hæmmere af nukleotidgruppen (NRTI) som førstevalgsbehandling.
English: Tenofovir also interferes with the action of an enzyme produced by the hepatitis B virus called ‘DNA polymerase', which is involved in the formation of viral DNA.
Danish: Tenofovir disoproxil Zentiva påvirker også virkningsmekanismen hos et enzym, som produceres af hepatitis B-virusset, såkaldt "dna-polymerase", der indgår i dannelsen af viralt dna.
English: For more information on how the medicine is taken including doses for adults and adolescents, see the summary of product characteristics (also part of the EPAR).
Danish: Se produktresuméet for nærmere oplysninger om, hvordan lægemidlet indtages, herunder doser til unge og voksne (også en del af denne EPAR).
English: For more information about treatment with Tenofovir disoproxil Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tenofovir disoproxil Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Tenofovir disoproxil Zentiva, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Danish: Det aktive stof i Tenofovir disoproxil Zentiva, tenofovirdisoproxil, er et såkaldt "prodrug" (et lægemiddelforstadium), der i kroppen omdannes til tenofovir.
English: What measures are being taken to ensure the safe and effective use of Tenofovir disoproxil Zentiva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tenofovir disoproxil Zentiva?
English: Tenofovir disoproxil Zentiva is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents aged 12 years and above with liver damage whose liver is still able to work (compensated liver disease).
Danish: Tenofovir disoproxil Zentiva anvendes også til behandling af kronisk (langvarig) hepatitis Bvirusinfektion hos voksne og unge i alderen 12 år og derover, hvis lever er beskadiget, men stadig fungerer (kompenseret leversygdom).
English: Because Tenofovir disoproxil Zentiva 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 Tenofovir disoproxil Zentiva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Tenofovir disoproxil Zentiva
Danish: Andre oplysninger om Tenofovir disoproxil Zentiva
English: Because Tenofovir disoproxil Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread.
Danish: Da Tenofovir disoproxil Zentiva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Viread.
English: What are the benefits and risks of Tenofovir disoproxil Zentiva?
Danish: Hvilke fordele og risici er der forbundet med Tenofovir disoproxil Zentiva?
English: What is Tenofovir disoproxil Zentiva and what is it used for?
Danish: Hvad er Tenofovir disoproxil Zentiva, og hvad anvendes det til?
English: Tenofovir disoproxil Zentiva tenofovir disoproxil
Danish: Tenofovir disoproxil Zentiva tenofovirdisoproxil
English: It is not intended to provide practical advice on how to use Tenofovir disoproxil Zentiva.
Danish: Det er ikke en praktisk vejledning i, hvordan Tenofovir disoproxil Zentiva bør anvendes.
English: Tenofovir disoproxil Zentiva is an antiviral medicine used to treat patients aged 12 years and above infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Tenofovir disoproxil Zentiva er et antiviralt lægemiddel, der anvendes til behandling af patienter i alderen 12 år og opefter, som er smittet med humant immundefektvirus type 1 (hiv-1).
English: Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI).
Danish: Tenofovir disoproxil Zentiva er en revers transkriptase-hæmmer af nukleotidgruppen (NRTI).
English: For practical information about using Tenofovir disoproxil Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tenofovir disoproxil Zentiva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tenofovir disoproxil Zentiva have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tenofovir disoproxil Zentiva.
English: Why is Tenofovir disoproxil Zentiva approved?
Danish: Hvorfor blev Tenofovir disoproxil Zentiva godkendt?
English: How has Tenofovir disoproxil Zentiva been studied?
Danish: Hvordan blev Tenofovir disoproxil Zentiva undersøgt?
English: This means that Tenofovir disoproxil Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viread.
Danish: Det betyder, at Tenofovir disoproxil Zentiva er identisk med et "referencelægemiddel",
English: How is Tenofovir disoproxil Zentiva used?
Danish: Hvordan anvendes Tenofovir disoproxil Zentiva?
English: Annex I List of medicinal products and presentations
Danish: Fortegnelse over lægemidler og lægemiddelformer
English: 25 June 2015
Danish: Den 25. juni 2015
English: Outcome of procedures under Article 29(4) of Directive 2001/83/EC
Danish: Resultatet af procedurer i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF
English: The European Commission adopted a decision on this opinion on 25 June 2015.
Danish: Europa-Kommissionen traf en beslutning om denne udtalelse den 25. juni 2015.
English: The company wanted the authorisation to be recognised in Belgium, Germany, Luxembourg and the Netherlands (the ‘concerned Member States').
Danish: Virksomheden ønskede denne godkendelse anerkendt i Belgien, Tyskland, Luxembourg og Nederlandene (de "berørte medlemsstater").
English: The CHMP therefore recommended that the marketing authorisation be granted in the concerned Member States.
Danish: CHMP anbefalede derfor, at der udstedes markedsføringstilladelse i de berørte medlemsstater.
English: On 23 April 2015, the European Medicines Agency completed two arbitration procedures following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Merisone and Myoson (tolperisone).
Danish: Den 23. april 2015 gennemførte Det Europæiske Lægemiddelagentur to voldgiftsprocedurer efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlerne Merisone og Myoson (tolperison).
English: However, the Member States were not able to reach an agreement and the German and Dutch medicines regulatory agencies referred the matter to the CHMP for arbitration on 24 December 2014.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den tyske og nederlandske lægemiddelstyrelse indbragte den 24. december 2014 sagen for CHMP med henblik på voldgift.
English: The grounds for the referral were that the bioequivalence studies had only been performed under fasting conditions.
Danish: Begrundelsen for henvisningen var, at bioækvivalensundersøgelserne kun var udført under fastende betingelser.
English: By reducing these impulses, tolperisone is believed to reduce muscle contraction and spacticity.
Danish: Ved at dæmpe disse impulser menes tolperison at nedsætte muskelsammentrækninger og spasticitet.
English: What are Merisone and Myoson?
Danish: Hvad er Merisone og Myoson?
English: Meditop Pharmaceutical Co. Ltd. submitted Merisone and Myoson for mutual recognition on the basis of their initial authorisation granted by Hungary on 18 March 2010.
Danish: Meditop Pharmaceutical Co. Ltd. indsendte en ansøgning for Merisone og Myoson med henblik på gensidig anerkendelse på grundlag af den oprindelige godkendelse, der var udstedt af Ungarn den 18. marts 2010.
English: Why were Merisone and Myoson reviewed?
Danish: Hvorfor blev Merisone og Myoson vurderet igen?
English: The active substance in Merisone and Myoson, tolperisone, is a centrally acting muscle relaxant.
Danish: Det aktive stof i Merisone og Myoson, tolperison, er et centralt virkende muskelafslappende middel.
English: Questions and answers on Merisone and Myoson (tolperisone, 50 and 150 mg tablets) EMA/252261/2015
Danish: Spørgsmål og svar om Merisone og Myoson (tolperison, tabletter, 50 og 150 mg) EMA/252261/2015
English: Questions and answers on Merisone and Myoson (tolperisone, 50 and 150 mg tablets)
Danish: Spørgsmål og svar om Merisone og Myoson (tolperison, tabletter, 50 og 150 mg)
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Merisone and Myoson outweigh their risks, and the marketing authorisation granted in Hungary can be recognised in other Member States of the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Merisone og Myoson er større end risiciene, og at den markedsføringstilladelse, der er udstedt i Ungarn, kan anerkendes i de øvrige EU-medlemsstater.
English: Merisone and Myoson are identical medicines that are used to treat muscle spasms (involuntary contractions) and spasticity.
Danish: Merisone og Myoson er identiske lægemidler, der anvendes til behandling af ufrivillige muskelsammentrækninger (spasmer) og spasticitet.
English: Merisone and Myoson are generic medicines based on a ‘reference medicine', Mydeton, which is already authorised in the EU.
Danish: Merisone og Myoson er generiske lægemidler, der er baseret på et "referencelægemiddel", som allerede er godkendt i EU.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that because of the characteristics of the active substance of Merisone and Myoson food will affect the absorption of the active substance in the same way as for Mydeton and no further studies are required.
Danish: Efter at have vurderet de aktuelt foreliggende data og de videnskabelige drøftelser i udvalget konkluderede CHMP, at der ikke er behov for supplerende undersøgelser, fordi egenskaberne af det aktive indholdsstof i Merisone og Myoson bevirker, at absorptionen af det aktive stof i disse lægemidler vil påvirkes på samme måde af fødeindtagelse som for Mydeton.
English: The CHMP therefore concluded that in the case of Merisone and Myoson the bioequivalence study in the fasting state is sufficient to conclude on the bioequivalence in both the fasting and fed states and that the benefits and risks of Merisone and Myoson can be taken to be the same as the reference medicine's.
Danish: CHMP konkluderede derfor, at bioækvivalensundersøgelsen af Merisone og Myoson i fastende tilstand er tilstrækkelig til, at der kan fastslås bioækvivalens i både fastende og ikke-fastende tilstand, og at fordelene og risiciene ved Merisone og Myoson kan antages at være de samme som for referencelægemidlet.
English: As the product information for Mydeton was recently updated to say that it should be taken with food, Germany and the Netherlands considered that a bioequivalence study under fed conditions would be required for the granting of a marketing authorisation.
Danish: Tyskland og Nederlandene fandt derfor, at det ville være nødvendigt med en bioækvivalensundersøgelse under ikke-fastende betingelser, for at der kan udstedes markedsføringstilladelse.
English: Because Merisone and Myoson are generic medicines, studies have been limited to tests to determine that they are bioequivalent to the reference medicine, Mydeton.
Danish: Undersøgelserne har derfor kun skullet vise, at de er bioækvivalente med referencelægemidlet Mydeton.
English: - If you are very overweight.
Danish: - Hvis du meget overvægtig.
English: % difference
Danish: % forskel
English: This serious allergic reaction needs immediate medical attention.
Danish: Denne alvorlige allergiske reaktion kræver omgående lægebehandling.
English: QUALITATIVEAND QUANTITATIVE COMPOSITION
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: Up to 14 Days
Danish: Op til 14 dage
English: This interference led to a false prolongation of PT and elevation of INR.
Danish: Denne interferens førte til en falsk forlængelse af PT og øget INR.
English: Steady-state concentrations are achieved by the third daily dose.
Danish: Steady state-koncentrationer opnås ved den tredje daglige dosis.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
Danish: Eftersom disse reaktioner er indberettet frivilligt fra en population af ubestemt størrelse, er det ikke muligt at estimere en pålidelig hyppighed; den er derfor kategoriseret som ikke kendt.
English: However, from a microbiological point of view the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet dog anvendes straks.
English: PP (per protocol) Population RIE
Danish: PP (per protokol)-population RIE
English: - If you have, or have previously had kidney problems.
Danish: - Hvis du har eller tidligere har haft problemer med nyrerne.
English: The dose will depend on how much you weigh and the type of infection being treated.
Danish: Dosis afhænger af, hvor meget du vejer, og hvilken type infektion du behandles for.
English: The differences noted are most likely due to the normal reduction in renal function observed in the geriatric population.
Danish: Forskellene skyldes sandsynligvis den normale nyrefunktionsnedsættelse, der ses i den geriatriske population.
English: The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses.
Danish: Den mest almindelige infektion, der blev behandlet, var sårinfektion (38% af patienterne), mens 21% havde store abscesser.
English: This mode of administration was only studied in healthy subjects.
Danish: Denne administrationsvej er kun undersøgt hos raske frivillge.
English: The duration of therapy should be in accordance with available official recommendations.
Danish: Varigheden af behandlingen skal være i overensstemmelse med tilgængelige officielle anbefalinger.
English: The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Resistensprævalensen kan variere geografisk og tidsmæssigt for udvalgte arter, og lokal information om resistens er ønskelig, især når svære infektioner behandles.
English: Detailed instructions for use and handling are given at the end of the leaflet.
Danish: Detaljerede instruktioner i brug og håndtering findes i slutningen af denne indlægsseddel.
English: As the pharmacokinetics (see section 5.2) is comparable, the safety margins for both methods of administration are very similar.
Danish: 5.2) er sammenlignelig, er sikkerhedsmarginerne for begge administrationsmetoder meget ens.
English: The specific cell surface component directly targeted has not been identified.
Danish: Det direkte måls specifikke celleoverfladekomponent er ikke blevet identificeret.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle retningslinjer angående hensigtsmæssig brug af antibakterielle lægemidler bør tages i betragtning.
English: <Date of first authorisation: 22-March-2017> <Date of latest renewal: {DD month YYYY}>
Danish: Dato for første markedsføringstilladelse: 22. marts 2017 <Dato for seneste fornyelse: {DD måned ÅÅÅÅ}>
English: In the event of overdose, supportive care is advised.
Danish: I tilfælde af overdosering, tilrådes understøttende behandling.
English: There was no relevant difference in local tolerability or in the nature and frequency of adverse reactions.
Danish: Der var ingen relevant forskel i lokal tolerabilitet eller i type og frekvens af bivirkninger.
English: Clinically evaluable (CE)
Danish: Klinisk evaluerbar (CE)
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Summary of overall therapeutic response by type of baseline pathogen (ME population):
Danish: Oversigt over samlet terapeutisk respons i henhold til type af baseline-patogen (ME-population):
English: For blood or heart infections and skin infections your doctor will decide how long you should be treated.
Danish: Ved infektioner i blodet eller hjertet og hudinfektioner vil lægen afgøre, hvor lang tid du skal behandles.
English: The use of antibacterials may promote the overgrowth of non-susceptible micro-organisms.
Danish: Brug af antibakterielle midler kan forårsage overvækst af ikke-følsomme mikroorganismer.
English: The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.
Danish: Det fuldt rekonstituerede produkt fremstår klart, og der er eventuelt et par små bobler eller skum langs kanten på hætteglasset.
English: Modified intent-to-treat (MITT) Microbiologically modified intent-to-treat (mMITT)
Danish: Modificeret intent-to-treat (MITT) Mikrobiologisk modificeret intent-to-treat (mMITT)
English: No patients 1 to <2 years of age were enrolled in the study.
Danish: Der blev ikke indrulleret patienter i alderen 1 til <2 år i studiet.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du får dette lægemiddel.
English: The dose for children and adolescents (1 to 17 years of age) will depend on the age of patient and the type of infection being treated.
Danish: Dosis til børn og unge (i alderen 1-17 år) vil afhænge af patientens alder og hvilken type infektion, der behandles.
English: Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Danish: Daptomycin er et antibakterielt middel, der kan stoppe væksten af visse bakterier.
English: This finding was not associated with an effect on muscle contraction.
Danish: Dette fund var ikke forbundet med en virkning på muskelkontraktion.
English: There were no differences in Cmax.
Danish: Der var ingen forskel i Cmaxværdier.
English: However, there is currently no evidence that a dose reduction is required (see section 5.2).
Danish: Der er dog p.t. intet der tyder på, at en dosisreduktion er nødvendig (se pkt.
English: Peripheral nerve changes were characterised by minimal to slight axonal degeneration and were frequently accompanied by functional changes.
Danish: Forandringer i de perifere nerver var karakteriseret af minimal til let aksonal degeneration og blev ofte ledsaget af funktionelle forandringer.
English: UNIQUE IDENTIFIER -2D BARCODE
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: A course of treatment usually lasts for 1 to 2 weeks for skin infections.
Danish: En behandling varer normalt 1-2 uger ved hudinfektioner.
English: Adults (18 years of age and above)
Danish: Voksne (18 år og derover)
English: Reversal of both the microscopic and functional effects was complete within 6 months post-dose.
Danish: Reversering af både mikroskopisk og funktionel effekt var komplet inden for 6 måneder efter sidste dosis.