FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of this medicine do not outweigh its risks, and the marketing authorisation granted in the United Kingdom cannot be recognised in other Member States of the EU: France and Spain.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved dette lægemiddel ikke opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Det Forenede Kongerige, ikke kan anerkendes i to andre EUmedlemsstater, nemlig Frankrig og Spanien.
English: Isotretinoin works by decreasing the size and activity of the sebaceous glands in the skin, reducing sebum production and inflammation in the skin.
Danish: Isotretinoin virker ved at mindske størrelsen af og aktiviteten i hudens talgkirtler, så talgproduktionen og betændelsen i huden aftager.
English: Ranbaxy (UK) Limited submitted the generic isotretinoin-containing medicine for mutual recognition on the basis of the initial authorisation granted by the United Kingdom (the ‘reference Member State') on 20 November 2006.
Danish: Ranbaxy (UK) Limited ansøgte om gensidig anerkendelse af det generiske lægemiddel, der indeholder isotretinoin, på baggrund af den første markedsføringstilladelse, der blev udstedt af Det Forenede Kongerige ("referencemedlemsstaten") den 20. november 2006.
English: The grounds for the referral were that the bioequivalence study to show that Ranbaxy's isotretinoin capsules produce the same levels of active substance in the body as Roaccutane had been performed under fasting conditions.
Danish: Begrundelserne for indbringelsen var, at den bioækvivalensundersøgelse, der skulle vise, at isotretinoinkapsler fra Ranbaxy danner de samme niveauer af det aktive stof i kroppen som Roaccutane, var blevet udført i fastende tilstand.
English: The CHMP considered that demonstration of bioequivalence in the fed state was essential and in line with current guidance on investigation of bioequivalence.
Danish: CHMP var af den opfattelse, at påvisning af bioækvivalens efter fødeindtagelse var væsentlig og i overensstemmelse med den aktuelle vejledning om undersøgelse af bioækvivalens.
English: However, the company was unable to demonstrate bioequivalence under fed conditions.
Danish: Virksomheden var dog ikke i stand til at påvise bioækvivalens efter fødeindtagelse.
English: Acne is a skin disease caused by an excessive production of sebum (the skin's natural oil) from overactive sebaceous glands in the skin.
Danish: Akne er en hudsygdom, der skyldes en overproduktion af talg (naturligt hudfedt) fra overaktive talgkirtler i huden.
English: Pharmaceutical form
Danish: Lægemidd elform
English: Route of administration
Danish: Administratio n
English: 100 x 1 tablets (unit dose)
Danish: 100 x 1 tabletter (enkeltdosis)
English: MA (EU) Number Invented name
Danish: (Særnavn) Navn
English: Route of administration Packaging Package size
Danish: Emballage Pakningsstørrelse
English: EU Numbers
Danish: EU- nummer
English: Solution for injection vial (glass)
Danish: Injektionsvæske, opløsning
English: The European Commission granted a marketing authorisation valid throughout the EU for Combivir on 18 March 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Combivir den 18. marts 1998.
English: After 12 weeks, the viral load had fallen by more than 95%.
Danish: Efter 12 uger var virusindholdet faldet med over 95 %.
English: The full EPAR for Combivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Combivir 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 Combivir.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Combivir.
English: Other information about Combivir
Danish: Andre oplysninger om Combivir
English: Combivir lamivudine / zidovudine
Danish: Combivir lamivudin/zidovudin
English: Because lamivudine and zidovudine have been available in the EU for a number of years, the company presented information from earlier studies of the two substances taken together.
Danish: Da lamivudin og zidovudin har været tilgængelige i EU i en årrække, har virksomheden fremlagt oplysninger fra tidligere undersøgelser, hvor de to stoffer blev givet sammen.
English: What measures are being taken to ensure the safe and effective use of Combivir?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Combivir?
English: CD4 cells (also called CD4 T cells) are white blood cells that are important for fighting infections, but they are killed by HIV.
Danish: CD4-celler (også kaldet CD4 T-celler) er hvide blodlegemer, der er vigtige i bekæmpelsen af infektioner, men som dræbes af hiv.
English: In children (below 12 years of age) weighing between 14 and 30 kg, the dose depends on their weight.
Danish: Hos børn (på under 12 år), som vejer mellem 14 og 30 kg, afhænger dosis af deres vægt.
English: Patients who cannot swallow tablets may crush the tablets, adding the powder to a small amount of food or drink and swallowing it immediately.
Danish: Patienter, der ikke kan sluge tabletter, kan knuse tabletterne og komme pulveret i lidt mad eller drikke og indtage det straks.
English: The two groups also had similar rises in CD4 cell counts.
Danish: De to grupper havde også samme stigning i CD4celletallet.
English: Combivir was absorbed in the same way as the separate tablets.
Danish: Combivir blev absorberet på samme måde som de separate tabletter.
English: Why is Combivir approved?
Danish: Hvorfor blev Combivir godkendt?
English: Combivir does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Combivir helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Treatment with Combivir should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandlingen med Combivir bør indledes af en læge med erfaring i behandling af hivinfektion.
English: What is Combivir and what is it used for?
Danish: Hvad er Combivir, og hvad anvendes det til?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Combivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Combivir opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Combivir.
English: It is not intended to provide practical advice on how to use Combivir.
Danish: Det er ikke en praktisk vejledning i, hvordan Combivir bør anvendes.
English: Children taking Combivir should be closely monitored and the doctor may need to adjust the dose in case of side effects on their digestive system.
Danish: Børn, som får Combivir, bør overvåges nøje, og det kan være nødvendigt, at lægen justerer dosis i tilfælde af bivirkninger i fordøjelsessystemet.
English: They work in similar ways by blocking the activity of reverse transcriptase, an enzyme made by the HIV virus that allows it to reproduce itself in the cells it has infected.
Danish: De virker på ensartet vis ved at blokere aktiviteten af revers transcriptase, som er et enzym, hivvirusset producerer, så det kan formere sig i de celler, det har inficeret.
English: The company also compared how the body absorbed the Combivir combination tablet and the separate tablets.
Danish: Virksomheden foretog også en sammenligning af, hvordan kroppen absorberede Combivirkombinationstabletten og de separate tabletter.
English: Combivir must not be used by patients with low neutrophil counts (a type of white blood cell) or anaemia (low red blood cell counts).
Danish: Combivir må ikke anvendes til patienter med et lavt neutrofiltal (en type hvide blodlegemer) eller anæmi (lavt antal røde blodlegemer).
English: Combivir is available as tablets containing lamivudine 150 mg and zidovudine 300 mg.
Danish: Combivir fås som tabletter indeholdende 150 mg lamivudin og 300 mg zidovudin.
English: It also presented information on the predicted blood levels of the two substances in children taking the two substances combined in one tablet.
Danish: Virksomheden fremlagde desuden oplysninger om det forventede indhold af de to stoffer i blodet hos børn, der får de to stoffer samlet i én tablet.
English: The most common side effects with Combivir (which may affect more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Combivir (som optræder hos flere end 1 ud af 10 patienter) er diarré og kvalme.
English: If patients need to stop taking lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing lamivudine or zidovudine separately.
Danish: Hvis en patient skal holde op med at tage lamivudin eller zidovudin eller skal have en anden dosis på grund af problemer med nyrerne, leveren eller blodet, må patienten tage lægemidler, der indeholder lamivudin eller zidovudin hver for sig.
English: The company also compared Combivir to separate tablets of lamivudine and zidovudine in 75 patients aged over 12 years who had not taken treatment for HIV infection before.
Danish: Virksomheden sammenlignede desuden Combivir med separate tabletter med lamivudin og zidovudin hos 75 patienter på over 12 år, som ikke tidligere var blevet behandlet for hivinfektion.
English: What are the risks associated with Combivir?
Danish: Hvilke risici er der forbundet med Combivir?
English: CHMP considered that combining the active ingredients in a single tablet may be of advantage because it can improve how well patients stick to the prescribed treatment and this can help to prevent HIV becoming resistant to treatment.
Danish: CHMP var af den opfattelse, at det kan være en fordel, at de aktive stoffer er kombineret i en enkelt tablet, da det kan gøre det lettere for patienterne at overholde behandlingen, og det kan bidrage til at undgå, at hiv bliver resistent over for behandling.
English: For more information about treatment with Combivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandlingen med Combivir, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: To support its recommendations for Combivir doses in children, the company presented studies of the levels of lamivudine and zidovudine in the blood of children taking the medicines separately.
Danish: For at understøtte sine anbefalinger vedrørende Combivir-dosen hos børn fremlagde virksomheden undersøgelser af blodets indhold af lamivudin og zidovudin hos børn, der fik lægemidlerne hver for sig.
English: Both active substances in Combivir, lamivudine and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Danish: Begge de aktive stoffer i Combivir, lamivudin og zidovudin, er reverse transcriptase-hæmmere af nukleosidtypen (NRTI'er).
English: The recommended dose of Combivir for patients over 12 years of age who weigh at least 30 kg is one tablet taken twice a day.
Danish: Til patienter på over 12 år, som vejer mindst 30 kg, er den anbefalede dosis Combivir én tablet to gange dagligt.
English: The studies showed that the active substances taken together could reduce viral loads (the level of HIV in the blood) and allow CD4 cell counts to rise after up to one year of treatment.
Danish: Undersøgelserne viste, at de aktive stoffer, når de blev taget sammen, kunne nedsætte indholdet af hivvirus i blodet og få CD4-celletallet til at stige efter op til ét års behandling.
English: The recommended doses of Combivir in children produced similar levels of the two active substances as in older patients.
Danish: Med den anbefalede dosis af Combivir opnåedes det samme indhold af de to aktive stoffer hos børn som hos ældre patienter.
English: Combivir, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Combivir i kombination med mindst ét andet antiviralt lægemiddel nedsætter hivmængden i blodet og holder den nede.
English: For the full list of all the side effects of Combivir and restrictions on its use, see the package leaflet.
Danish: Den fuldstændige liste over bivirkningerne ved Combivir og begrænsningerne for anvendelsen heraf fremgår af indlægssedlen.
English: The main measures of effectiveness were the change in viral load and CD4 cell counts in the blood.
Danish: Virkningen blev hovedsagelig målt på ændringen i virusindholdet og CD4-celletallet i blodet.
English: Combivir, an antiviral medicine, is used in combination with at least one other antiviral medicine to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Combivir, som er et antiviralt lægemiddel, anvendes sammen med mindst ét andet antiviralt lægemiddel til behandling af patienter, som er inficeret med hiv (humant immundefektvirus).
English: Combivir contains two active substances, lamivudine and zidovudine.
Danish: Combivir indeholder de to aktive stoffer lamivudin og zidovudin.
English: For practical information about using Combivir, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Combivir, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefit of Combivir have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Combivir?
English: How is Combivir used?
Danish: Hvordan anvendes Combivir?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Combivir 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 Combivir.
English: Patients taking Combivir and those taking the two active substances separately had similar falls in viral load.
Danish: De patienter, der fik Combivir, havde samme fald i virusindholdet som dem, der fik de to aktive stoffer hver for sig.
English: How does Combivir work?
Danish: Hvordan virker Combivir?
English: If symptoms persist for longer than a week, a doctor should be consulted.
Danish: Hvis symptomerne fortsætter længere end en uge, bør der søges læge.
English: The studies indicated that 1,8 cineole might have an effect in diseases of the airways.
Danish: Undersøgelserne viste, at 1,8-cineol kan have en virkning ved luftvejssygdomme.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines when used in the way described above.
Danish: På tidspunktet for HMPC's vurdering var der ikke indberettet nogen bivirkninger af disse lægemidler ved ovenstående anvendelse.
English: Eucalyptus leaf is the common name for the whole or cut leaf of the tree Eucalyptus globulus Labill.
Danish: Eukalyptusblade er fællesnavnet for hele eller skårne blade af træet Eucalyptus globulus Labill.
English: Information on the use and licensing of eucalyptus leaf medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse i EU's medlemsstater af lægemidlermed eukalyptusblade, skal indhentes fra de relevante nationale myndigheder.
English: EMA/HMPC/300235/2013
Danish: EMA/HMPC/300235/2013 Udvalget for Plantelægemidler (HMPC)
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of eucalyptus leaf.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af eukalyptusblade.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing eucalyptus leaf.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder eukalyptusblade.
English: Any applications for the licensing of medicines containing eucalyptus leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, med eukalyptusblade, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: The HMPC recommended that eucalyptus leaf medicines should not be used in children under 30 months of age because of the risk of laryngospasm (contraction of the vocal cords).
Danish: HMPC har anbefalet, at lægemidler indeholdende eukalyptusblade ikke anvendes til børn under 30 måneder på grund af risikoen for krampe i stemmelæberne (laryngospasme).
English: Comminuted preparations of eucalyptus leaf should only be used in adults and children over the age of 12 years, while tincture preparations should only be used in adults due to high content of ethanol (pure alcohol).
Danish: Lægemidler med eukalyptusblade bør kun anvendes af voksne og børn over 12 år, mens tinkturer kun bør anvendes af voksne på grund af det høje indhold af ethanol (ren alkohol).
English: Further information on the HMPC assessment of eucalyptus leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder eukalyptusblade, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions on the use of eucalyptus leaf medicines for the relief of cough associated with a cold are based on their ‘traditional use' in this condition.
Danish: HMPC's konklusionervedrørende brugen af lægemidler med eukalyptusblade som hostestillende middel ved forkølelse er baseret på den "traditionelle anvendelse".
English: Further information on the risks associated with eucalyptus leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, med eukalyptusblade, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instruction on how to take eucalyptus leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med eukalyptusblade skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: This summary is not intended to provide practical advice on how to use medicines containing eucalyptus leaf.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder eukalyptusblade, anvendes.
English: Eucalyptus leaf EMA/HMPC/300235/2013
Danish: Eukalyptusblade EMA/HMPC/116785/2014
English: Other information about eucalyptus leaf medicines
Danish: Andre oplysninger om lægemidler, der indeholder eukalyptusblade
English: Preparations from dried eucalyptus leaf are obtained by comminuting (reducing into tiny pieces) the dried leaves of older branches of the tree, or by using them to produce a tincture (an alcoholic extract of the plant material).
Danish: Eukalyptusblade forarbejdes enten ved findeling af de tørrede blade fra ældre grene på træet eller ved fremstilling af en tinktur (en alkoholisk ekstrakt af plantematerialet).
English: Eucalyptus leaf
Danish: Eukalyptusblade
English: How are eucalyptus leaf medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder eukalyptusblade, i EU?
English: What evidence supports the use of eucalyptus leaf medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af eukalyptusblade?
English: What are the risks associated with eucalyptus leaf medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder eukalyptusblade?
English: What is eucalyptus leaf?
Danish: Hvad er eukalyptusblade?
English: For more information about treatment with eucalyptus leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder eukalyptusblade, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC concluded that, on the basis of its long-standing use, eucalyptus leaf can be used for the relief of cough associated with a cold.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at eukalyptusblade kan anvendes som hostestillende middel ved forkølelse.
English: For practical information about using eucalyptus leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med eukalyptusblade, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Herbal medicines containing eucalyptus leaf are usually available as comminuted herbal material for the preparation of a herbal tea to be drunk, an infusion to be inhaled or a liquid to be taken by mouth.
Danish: Plantelægemidler med eukalyptusblade fås normalt enten som findelt materiale til fremstilling af en urtete til drikkebrug, eller som tinktur / opløsning beregnet til indånding eller til at drikke.. Eukalyptusblade findes desuden kombineret med andre droger i visse plantelægemidler.
English: In its assessment, the HMPC considered the results of laboratory tests as well as studies in patients looking in particular at the effects of a component of eucalyptus leaf, called 1,8 cineole (also known as eucalyptol).
Danish: Dette gælder især virkningen af 1,8-cineol (også kaldet eucalyptol), der er ett særligt stof i eukalyptusblade.
English: 1 bottle + 1 measuring spoon
Danish: 1 flaske + måleske
English: 210 ml
Danish: Oral anvendelse Flaske (HDPE) 210 ml
English: Package size mg/ml
Danish: EU/1/06/343/005 Baraclude 0,05 mg/ml Oral opløsning
English: 26 July 2018
Danish: 26. juli 2018
English: There may be local regulations for disposal.
Danish: Der kan være en lokal lovgivning om bortskaffelse.
English: Wash your hands thoroughly with soap and water.
Danish: Vask hænderne grundigt med sæbe og vand.
English: Of these, more than 1,300 patients were exposed for at least 12 months.
Danish: Af disse blev flere end 1.300 patienter eksponeret i mindst 12 måneder.
English: This can dry out the medicine.
Danish: Dette kan udtørre medicinen.
English: It should also be protected from direct sunlight.
Danish: Den bør også beskyttes mod direkte sollys.
English: Contact your doctor.
Danish: Kontakt din læge.
English: The injection could take about 15 seconds.
Danish: Indsprøjtningen kan godt tage omkring 15 sekunder.
English: Evaluation of the need to continue treatment is recommended regularly thereafter.
Danish: Det anbefales at vurdere behovet for at fortsætte behandlingen regelmæssigt herefter.