FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults, the most common side effects with IntronA used with or without ribavirin (seen in more than 1 patient in 10) are pharyngitis (sore throat), viral infection, leucopenia (low white blood cell counts), loss of appetite, depression, insomnia (difficulty sleeping), anxiety, emotional lability (mood swings), agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, dyspnoea (difficulty breathing), coughing, nausea (feeling sick) or vomiting, abdominal pain (stomach ache), diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (heartburn), alopecia (hair loss), pruritus (itching), dry skin, rash, increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), rigors (shaking chills), pyrexia (fever), flu-like symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss.
Danish: Hos voksne er de hyppigst forekommende bivirkninger ved IntronA anvendt med eller uden ribavirin (set hos flere end 1 ud af 10 patienter) faryngitis (ondt i halsen), virusinfektion, leukopeni (lavt antal hvide blodlegemer), appetitløshed, depression, insomni (søvnbesvær), angst, emotionel labilitet (humørsvingninger), uro, nervøsitet, svimmelhed, hovedpine, nedsat koncentrationsevne, mundtørhed, sløret syn, dyspnø (vejrtrækningsbesvær), hoste, kvalme eller opkastning, mavesmerter, diarré, stomatitis (betændelse i mundslimhinden), dyspepsi (halsbrand), alopeci (hårtab), kløe, tør hud, udslæt, øget svedproduktion, muskelsmerter, ledsmerter, smerter i muskler og knogler, reaktioner på injektionsstedet (herunder betændelse), træthed, kulderystelser, pyreksi (feber), influenzalignende symptomer, asteni (svaghed), irritabilitet, brystsmerter, utilpashed og vægttab.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that IntronA's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved IntronA opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for IntronA.
English: EPAR summary for the public interferon alfa 2b
Danish: EPAR - sammendrag for offentligheden interferon alfa 2b
English: The interferon alfa-2b in IntronA is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Danish: Interferon alfa-2b i IntronA produceres ved en metode, der kaldes "rekombinant DNAteknologi": Det produceres af en bakterie, der har modtaget et gen (DNA), som sætter bakterien i stand til at producere interferon alfa-2b.
English: • carcinoid tumour (a tumour of the endocrine system that produces hormones);
Danish: • karcinoid tumor (en tumor i det endokrine system, der producerer hormoner),
English: Because interferon alfa 2b has been used in the EU for a number of years, the company presented the results of studies from the published literature, as well as from studies of its use with cytarabine in CML and studies of IntronA used alone (in adults) or with ribavirin (in patients from three years of age) for the treatment of long-term hepatitis C. The main measures of effectiveness were the number of patients who responded to treatment in the hepatitis studies and how long the patients survived in the cancer studies.
Danish: Da interferon alfa-2b er blevet anvendt i EU i nogle år, har virksomheden fremlagt resultaterne af undersøgelser fra den offentliggjorte litteratur og fra undersøgelser af brugen af interferon alfa-2b sammen med cytarabin til kronisk myeloid leukæmi samt undersøgelser af IntronA anvendt alene (hos voksne) eller sammen med ribavirin (hos patienter, der er mindst tre år gamle) til behandling af langvarig hepatitis C. Det primære effektmål var antallet af patienter, der responderede på behandlingen i hepatitisundersøgelserne, og hvor længe patienterne overlevede i kræftundersøgelserne.
English: IntronA is used to maintain anticancer effects in patients who have responded to previous treatment with anticancer medicines;
Danish: IntronA anvendes til at opretholde de kræfthæmmende virkninger hos patienter, der har reageret positivt på tidligere behandling med lægemidler mod kræft,
English: The studies showed that IntronA is effective in the diseases for which it can be used.
Danish: Undersøgelserne viste, at IntronA er effektivt til behandling af de sygdomme, som det er indiceret til.
English: IntronA must not be used in patients with severe kidney or liver disease, epilepsy or other central nervous system problems, or thyroid disease that is not controlled.
Danish: IntronA må ikke anvendes hos patienter med alvorlig nyre- eller leversygdom, epilepsi, andre problemer med centralnervesystemet eller ukontrollerede skjoldbruskkirtelsygdomme.
English: Why has IntronA been approved?
Danish: Hvorfor blev IntronA godkendt?
English: It must not be used in patients who have had severe heart disease or certain immune system disorders, in patients who are taking medicines that suppress the immune system, in hepatitis patients who have liver cirrhosis (scarring) that is causing symptoms or who have recently received medicines that affect the immune system, or in children or adolescents with a history of severe mental illness, particularly severe depression, thoughts about committing suicide or suicide attempts.
Danish: Det må ikke anvendes hos patienter, som har haft en alvorlig hjertesygdom eller visse sygdomme i immunsystemet, hos patienter, som tager immunosuppressive lægemidler, hos hepatitispatienter med levercirrose, der giver symptomer, eller som for nylig er blevet behandlet med lægemidler, der påvirker immunsystemet, eller hos børn eller unge, der tidligere har haft alvorlige psykiske sygdomme, navnlig svær depression, selvmordstanker eller selvmordsforsøg.
English: The active substance in IntronA, interferon alfa-2b, belongs to the group ‘interferons'.
Danish: Det aktive stof i IntronA, interferon alfa-2b, hører til gruppen af "interferoner".
English: What is the risk associated with IntronA?
Danish: Hvilken risiko er der forbundet med IntronA?
English: IntronA is a medicine that contains the active substance interferon alfa-2b.
Danish: IntronA er et lægemiddel, der indeholder det aktive stof interferon alfa-2b.
English: IntronA should not be used in people who may be hypersensitive (allergic) to interferon alfa 2b or any of the other ingredients.
Danish: IntronA bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for interferon alfa-2b eller nogle af de øvrige indholdsstoffer.
English: • long-term hepatitis B (a disease of the liver due to infection with the hepatitis B virus) in adults (aged 18 years and older);
Danish: • langvarig hepatitis B (en leversygdom, der skyldes en infektion med hepatitis B-virus) hos voksne (personer på 18 år eller derover),
English: In children and adolescents receiving IntronA in combination with ribavirin, side effects were similar to adults, although anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), hypothyroidism (underactive thyroid gland) and reduced growth were also seen in more than 1 patient in 10.
Danish: Hos børn og unge, der fik IntronA i kombination med ribavirin, var bivirkningerne de samme som hos voksne, selv om der ligeledes forekom anæmi (lavt antal røde blodlegemer), neutropeni (lavt antal neutrofiler, som er en type hvide blodlegemer), hypothyroidisme (nedsat skjoldbruskkirtelfunktion) og nedsat vækst hos flere end 1 ud af 10 patienter.
English: The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
Danish: Erstatningsinterferon alfa-2b virker på samme måde som naturligt produceret interferon alfa.
English: • malignant melanoma (a type of skin cancer affecting cells called melanocytes).
Danish: • malignt melanom (modermærkekræft - en type hudkræft, der påvirker de celler, der kaldes melanocytter).
English: • long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Danish: • langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus) hos patienter, der er mindst 3 år gamle.
English: The dose and duration of treatment depend on the disease being treated and the response of the patient, with doses ranging from 2 to 20 million IU per square metre of body surface area (calculated using the patient's height and weight).
Danish: Doserne ligger i området fra 2 til 20 millioner IE pr. kvadratmeter legemsoverflade (beregnet ud fra patientens højde og vægt).
English: It is available as a powder and solvent that are made up into a solution for injection or infusion (drip into a vein), and as a readyto-use solution for injection in a vial or in a multidose pen.
Danish: Det fås som pulver og solvens, der skal blandes til en injektionsvæske eller infusionsvæske, opløsning (drop i en vene), og som en brugsklar injektionsvæske, opløsning, i et hætteglas eller i en flerdosispen.
English: For the full list of all side effects reported with IntronA, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved IntronA fremgår af indlægssedlen.
English: IntronA is used as an add-on to anticancer treatments;
Danish: IntronA anvendes som supplerende behandling til kræftbehandlinger,
English: Patients can inject themselves once they have been trained appropriately.
Danish: Når patienterne har fået tilstrækkelig instruktion, kan de selv begynde at foretage injektionen.
English: What is IntronA?
Danish: Hvad er IntronA?
English: In CML, more patients who received IntronA with cytarabine were still alive after three years than patients who only received IntronA.
Danish: Blandt patienterne med kronisk myeloid leukæmi var flere i live efter 3 år i den gruppe, som fik IntronA sammen med cytarabin, end i gruppen behandlet med IntronA alene.
English: For a list of all restrictions with IntronA, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger i forbindelse med IntronA fremgår af indlægssedlen.
English: How has IntronA been studied?
Danish: Hvordan blev IntronA undersøgt?
English: What is IntronA used for?
Danish: Hvad anvendes IntronA til?
English: • chronic myelogenous leukaemia (CML, a cancer of the white blood cells) in adults.
Danish: • kronisk myeloid leukæmi (CML) (en kræftform, der rammer de hvide blodlegemer) hos voksne.
English: What benefit has IntronA shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved IntronA?
English: • follicular lymphoma (a cancer of the lymph tissue).
Danish: • follikulær lymfom (kræft i lymfevævet).
English: How is IntronA used?
Danish: Hvordan anvendes IntronA?
English: • hairy cell leukaemia (a cancer of the white blood cells);
Danish: • hårcelleleukæmi (kræft i de hvide blodlegemer),
English: • multiple myeloma (a cancer of the bone marrow).
Danish: • multipel myelom (knoglemarvskræft).
English: How does IntronA work?
Danish: Hvordan virker IntronA?
English: This overview was last updated in 02-2018.
Danish: Denne oversigt blev sidst ajourført i 02-2018.
English: Other information about Truvada
Danish: Andre oplysninger om Truvada
English: The European Commission granted a marketing authorisation valid throughout the European Union for Truvada on 21 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Truvada den 21. februar 2005.
English: Further information on Truvada can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Truvada findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that it is converted into tenofovir in the body.
Danish: Det betyder, at det omdannes til tenofovir i kroppen.
English: An overview of Truvada and why it is authorised in the EU
Danish: En oversigt over Truvada og hvorfor det er godkendt i EU
English: As for all medicines, data on the use of Truvada is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Truvada løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Truvada?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Truvada?
English: Truvada is available as tablets.
Danish: Truvada fås som tabletter.
English: The level of protection depended on how well individuals stuck to taking their medicine.
Danish: Beskyttelsesniveauet afhang af, hvor gode personerne var til at tage deres medicin.
English: It should be used in combination with safer sex practices, such as use of condoms.
Danish: Det bør anvendes i kombination med sikker sex, hvor der f.eks. anvendes kondomer.
English: Why is Truvada authorised in the EU?
Danish: Hvorfor blev Truvada godkendt i EU?
English: What is Truvada and what is it used for?
Danish: Hvad er Truvada, og hvad anvendes det til?
English: What are the risks associated with Truvada?
Danish: Hvilke risici er der forbundet med Truvada?
English: There is a risk that pre-exposure prophylaxis may encourage risky behaviour but one of the main studies found that participation in the study reduced risky behaviour.
Danish: Der er en risiko for, at forebyggende behandling før eksponering kan fremme risikoadfærd, men en af hovedundersøgelserne viste, at deltagelsen i undersøgelsen mindskede risikofyldt adfærd.
English: Truvada was more effective than placebo for preventing HIV-1 infection.
Danish: Truvada var mere effektivt end placebo til at forebygge hiv-1-infektion.
English: Side effects reported with Truvada are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Truvada vurderes omhyggeligt, og der tages i givet fald nødvendige forholdsregler for at beskytte patienterne.
English: The Agency concluded that Truvada's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturet konkluderede at, fordelene ved Truvada opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
English: Around two-thirds of the patients achieved and maintained viral load below 50 copies/ml after 48 weeks.
Danish: Ca. to tredjedele af patienterne opnåede og fastholdt en virusbelastning på mindre end 50 kopier/ml efter 48 ugers behandling.
English: The second study involved over 4,700 heterosexual couples, each with one partner who did not have HIV-1 infection and the other who had the infection.
Danish: Den anden undersøgelse omfattede over 4.700 heteroseksuelle par, hvor den ene partner ikke havde hiv-1-infektion, mens den anden havde.
English: In addition it may be used from the age of 12 in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.
Danish: Desuden kan det anvendes fra 12 årsalderen hos unge med hiv, som er resistente over for de lægemidler, der anvendes som førstevalgsbehandling, eller som ikke kan tage dem på grund af bivirkninger.
English: Truvada 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: Truvada helbreder ikke hiv-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: The Agency also considered that the benefit of Truvada has been shown for pre-exposure prophylaxis but the level of protection depends on how well individuals stick to the recommended dose schedule.
Danish: Agenturet var også af den opfattelse, at fordelene ved Truvada var påvist til forebyggende behandling før eksponering, men beskyttelsesniveauet afhænger af, hvor gode personerne er til at overholde den anbefalede doseringsplan.
English: When the active substances emtricitabine or tenofovir are given separately, the most common side effects (seen in more than 1 patient in 10) also include hypophosphataemia (low levels of phosphates in the blood), headache, dizziness, vomiting, rash, weakness and raised blood levels of creatine kinase (an enzyme found in muscles).
Danish: Når det aktive stof emtricitabin eller tenofovir gives hver for sig, omfatter de hyppigste bivirkninger (som ses hos mere end 1 patient ud af 10) også hypofosfatæmi (for lavt fosfatindhold i blodet), hovedpine, svimmelhed, opkastning, udslæt, svaghed og forhøjet indhold i blodet af kreatinkinase (et enzym, der findes i musklerne).
English: In children, skin discoloration and anaemia (low red blood cell counts) are also common side effects.
Danish: Hos børn er misfarvning af huden og anæmi (lavt niveau af røde blodlegemer) også almindelig.
English: The recommended dose for treating or preventing HIV-1 infection is one tablet once a day, preferably taken with food.
Danish: Den anbefalede dosis til behandling eller forebyggelse af hiv-1-infektion er én tablet én gang dagligt, helst sammen med et måltid.
English: Individuals taking Truvada to prevent HIV-1 infection should be tested at least every 3 months to make sure that they are free of HIV-1.
Danish: Personer, der tager Truvada for at forebygge hiv-1 infektion, bør testes mindst hver 3. måned for at være sikre på, at de ikke har hiv-1.
English: The main measure of effectiveness was the number of adults who tested positive for HIV-1 infection.
Danish: Virkningen blev hovedsagelig målt på antallet af voksne, som blev testet positive for hiv-1infektion.
English: If patients with HIV-1 infection need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Danish: Hvis patienter med hiv-1-infektion skal holde op med at tage emtricitabin eller tenofovir eller skal have ændret dosis, skal de tage medicin indeholdende emtricitabin eller tenofovirdisoproxil hver for sig.
English: The European Medicines Agency noted that the benefit of Truvada for treating HIV-1 infection has only been shown in patients who have not taken HIV treatment before, but that the simplified dosing regimen offered by the combination tablet taken once a day may help patients to stick to their treatment.
Danish: Det Europæiske Lægemiddelagentur konstaterede, at fordelen ved Truvada til behandling af hiv-1infektion kun er påvist hos patienter, der ikke tidligere har fået medicin mod hiv, men at den forenklede doseringsplan med en kombinationstablet, der tages én gang dagligt, kan gøre det lettere for patienterne at overholde behandlingen.
English: The most common side effects in adults treated with Truvada are diarrhoea and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Truvada er diarré og kvalme.
English: The main measure of effectiveness was the proportion of patients whose HIV-1 level in the blood (viral load) had fallen below a defined level.
Danish: Virkningen blev hovedsagelig målt på andelen af patienter, hvis hiv-1-indhold i blodet (virusbelastning) var faldet til under et fastsat niveau.
English: Truvada (emtricitabine / tenofovir disoproxil)
Danish: Truvada (emtricitabin/tenofovirdisoproxil)
English: The effectiveness of Truvada in adolescents was supported by studies showing that emtricitabine or tenofovir disoproxil reduced viral load when given with other antivirals to HIV-infected patients aged from 12 to 18 years, as well as evidence that the active ingredients are distributed similarly in the bodies of adolescents to those of adults and so would be expected to act in the same way.
Danish: Virkningen af Truvada hos unge blev understøttet af undersøgelser, som viste, at emtricitabin eller tenofovirdisoproxil mindskede virusbelastningen, når de blev givet sammen med andre antivirale lægemidler til hiv-smittede patienter mellem 12 og 18 år, samt af dokumentation for, at de aktive indholdsstoffer fordeles i kroppen på samme måde hos unge og voksne og dermed forventes at virke på samme måde.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Danish: Emtricitabin og tenofovir virker begge ved at blokere revers transkriptase, et enzym, der produceres af hiv, og som gør det muligt for virussen at smitte celler og producere flere virusser.
English: How does Truvada work?
Danish: Hvordan virker Truvada?
English: Truvada can only be obtained with a prescription, and treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Truvada udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hiv-infektion.
English: Truvada contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Danish: Truvada er et lægemiddel, der indeholder to aktive stoffer, emtricitabin (200 mg) og tenofovirdisoproxil (245 mg).
English: Truvada is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Truvada anvendes sammen med mindst ét andet hiv-lægemiddel til behandling af voksne, som er smittet med humant immundefektvirus type 1 (hiv-1, et virus, som forårsager erhvervet immundefektsyndrom (aids)).
English: Two main studies have evaluated the addition of Truvada to standard preventative measures for preexposure prophylaxis.
Danish: To hovedundersøgelser så nærmere på tilføjelsen af Truvada til forebyggende standardforanstaltninger i forbindelse med forebyggende behandling før eksponering.
English: Both combinations were taken with efavirenz (another antiviral medicine) by patients with HIV-1 infection.
Danish: Begge kombinationer blev anvendt sammen med efavirenz (et andet antiviralt lægemiddel) af patienter med hiv-1-infektion.
English: Of the individuals taking Truvada, 0.8% (13 out of 1,576) tested positive for HIV-1 infection over 1 year compared with 3.3% (52 out of 1,578) of those taking placebo.
Danish: Blandt dem, der fik Truvada, blev 0,8 % (13 ud af 1.576) testet positive for hiv-1-infektion i løbet af 1 år sammenholdt med 3,3 % (52 ud af 1.578) af dem, der fik placebo.
English: In the first study involving over 2,400 men who have sex with men, 3.9% (48 out of 1,224) individuals taking Truvada tested positive for HIV-1 infection compared with 6.8% (83 out of 1,217) individuals taking placebo.
Danish: I den første undersøgelse, der omfattede over 2.400 mænd, der havde sex med mænd, blev 3,9 % (48 ud af 1.224) af dem, der fik Truvada, testet positive for hiv-1-infektion sammenholdt med 6,8 % (83 ud af 1.217) af dem, der fik placebo.
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Truvada in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Danish: Ved forebyggende behandling før eksponering for hiv-1-infektion forventes Truvada at forhindre virussen i blodet fra at formere og sprede sig fra infektionsstedet, hvis personen eksponeres for virussen.
English: The company that markets Truvada will provide an information pack to doctors which covers the risk of reduced kidney function with Truvada in adults and children, and information about use in adults for pre-exposure prophylaxis.
Danish: Desuden skal den virksomhed, der markedsfører Truvada, udlevere en pakke med information til læger, som omfatter risikoen for nedsat nyrefunktion ved Truvada hos voksne og børn, samt information om anvendelse hos voksne som forebyggende behandling før eksponering.
English: Truvada's active substances, taken in combination with other antiviral medicines, reduced viral load in the majority of patients and were more effective than the comparator medicines.
Danish: I kombination med andre antivirale lægemidler nedsatte de aktive stoffer i Truvada hiv-mængden i blodet hos størstedelen af patienterne og var mere effektive end sammenligningslægemidlerne.