FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the usefulness of Amyvid in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Danish: Desuden er det ikke fastslået, i hvor høj grad Amyvid er egnet til at forudsige Alzheimers sygdom hos patienter med hukommelsesproblemer eller til at overvåge patienternes respons på behandlingen.
English: This means that the PET scans were able to correctly identify as positive 92% of the patients who had significant amounts of plaques, and that all patients without significant plaques were correctly rated as negative.
Danish: Det betyder, at PET-scanningerne korrekt udpegede 92 % af patienterne med betydelige mængder plak som positive, og at alle patienter uden nævneværdig plak korrekt blev bedømt som negative.
English: PET scans with Amyvid should only be requested by doctors skilled in the clinical management of patients with neurodegenerative diseases such as Alzheimer's and other dementias.
Danish: PET-scanninger med Amyvid bør kun rekvireres af læger, der er kvalificeret til klinisk behandling af patienter med neurodegenerative lidelser såsom Alzheimers og andre former for demens.
English: The active substance in Amyvid, florbetapir (
Danish: Det aktive stof i Amyvid, florbetapir (
English: What is the risk associated with Amyvid?
Danish: Hvilken risiko er der forbundet med Amyvid?
English: A positive scan on its own, however, is not sufficient to make a diagnosis in patients with memory problems, as plaque deposition may be seen in patients with different types of neurodegenerative dementias as well as in elderly people with no symptoms.
Danish: En positiv scanning er dog i sig selv ikke nok til at stille diagnosen hos patienter med hukommelsesproblemer, da plakaflejringer både forekommer hos patienter med forskellige typer neurodegenerativ demens og hos ældre uden symptomer.
English: Amyvid is a solution for injection that contains the active substance florbetapir (
Danish: Amyvid er en injektionsvæske, der indeholder det aktive stof florbetapir (
English: Amyvid is given by injection into a vein about 30 to 50 minutes before obtaining an image from a PET scan.
Danish: Amyvid gives som en injektion i en vene 30-50 minutter før PET-scanningen.
English: Why has Amyvid been approved?
Danish: Hvorfor blev Amyvid godkendt?
English: After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Amyvid.
Danish: Når scanningen er udført, vurderes billedet af nuklearmedicinske læger, der er særligt oplært i at tolke PET-scanninger med Amyvid.
English: F), is a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Danish: F), er et radioaktivt lægemiddel, der udsender små mængder stråling og virker ved at bindes til β-amyloidplak i hjernen.
English: When it attaches to the plaques, the radiation it emits is then seen on the PET scan, enabling doctors to know whether or not significant amount of plaques are present.
Danish: Når stoffet bindes til plak, kan strålingen iagttages på PET-scanningen, så lægerne kan se, om der er betydelige mængder plak til stede.
English: What is Amyvid?
Danish: Hvad er Amyvid?
English: The study looked at sensitivity and specificity of the scans (how reliable they were at differentiating volunteers who had significant amounts of plaques in the brain from those who did not).
Danish: Undersøgelserne vedrørte scanningernes følsomhed og deres specificitet (dvs. hvor sikkert de var i stand til at skelne forsøgspersoner med betydelig plakdannelse i hjernen fra personer uden plak).
English: For the full list of all side effects reported with Amyvid, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Amyvid fremgår af indlægssedlen.
English: The Committee noted the good safety profile and non-invasive nature of the PET scans with Amyvid and concluded that
Danish: Udvalget bemærkede, at PET-scanning med Amyvid har en god sikkerhedsprofil og er ikke-invasiv, og konkluderede, at fordelene ved Amyvid overstiger risiciene.
English: The CHMP did, however, note that, partly due to the limited effects of current treatments for Alzheimer's disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Amyvid.
Danish: CHMP bemærkede dog, at der ikke er sikkert bevis for nogen øjeblikkelig bedring i udfaldet for patienterne efter PET-scanning med Amyvid, delvis som følge af de nuværende begrænsede behandlingsmuligheder for Alzheimers sygdom.
English: It is used for brain scans in adult patients with memory problems so that doctors can see whether or not they have significant amounts of β-amyloid plaques in the brain.
Danish: Amyvid anvendes til scanning af hjernen hos voksne patienter med hukommelsesproblemer for at lægerne kan se, om de har betydelige mængder β-amyloidplak i hjernen.
English: Among the patients, 59 had autopsies carried out on them to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Danish: Af patienterne fik de 59 foretaget obduktion for med sikkerhed at afgøre, om de havde betydelige mængder β-amyloidplak i hjernen.
English: PET scans with Amyvid were shown to have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Danish: PET-scanningerne med Amyvid havde høj følsomhed og specificitet til påvisning af β-amyloidplak i hjernen, og resultaterne af scanningerne stemte nøje overens med resultaterne af obduktionen.
English: What is Amyvid used for?
Danish: Hvad anvendes Amyvid til?
English: How has Amyvid been studied?
Danish: Hvordan blev Amyvid undersøgt?
English: PET scans with Amyvid were shown to have high specificity and sensitivity when used for identifying which patients had significant amounts of β-amyloid plaques in the brain.
Danish: Det blev påvist, at PET-scanning med Amyvid har høj specificitet og følsomhed til udpegelse af patienter med betydelige mængder β-amyloidplak i hjernen.
English: The specificity of the PET scans was 100% in 47 healthy volunteers, which means that all of their scans were rated as negative after being read by experts who were not aware if the scans belonged to healthy people or to patients.
Danish: Det betyder, at alle scanningerne blev bedømt som negative efter at være vurderet af eksperter, der ikke vidste, om scanningerne viste raske forsøgspersoner eller patienter.
English: A negative scan indicates sparse or no β-amyloid plaques, which means that the patient is unlikely to have Alzheimer's disease.
Danish: En negativ scanning tyder på sparsom eller ingen β-amyloidplak.
English: What benefit has Amyvid shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Amyvid?
English: How is Amyvid used?
Danish: Hvordan anvendes Amyvid?
English: How does Amyvid work?
Danish: Hvordan virker Amyvid?
English: • At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur;
English: As of week 144:
Danish: Fra uge 144:
English: • Talk to your doctor if you are over 65.
Danish: • Tal med Deres læge, hvis De er over 65 år.
English: These events have often been transitory.
Danish: Reaktionerne har ofte været forbigående.
English: Such changes may in part be linked to disease control and life style.
Danish: Sådanne ændringer kan delvist være knyttet til sygdomskontrol og livsstil.
English: Date of first authorisation: 16 December 2016
Danish: Dato for første markedsføringstilladelse: 16. december 2016
English: Staggered administration (12 hours apart) provided similar results.
Danish: Forskudt administration (12 timers mellemrum) gav tilsvarende resultater.
English: The frequency of the following side effects is not known.
Danish: Hyppigheden af følgende bivirkninger kendes ikke.
English: Years aware of discordant status
Danish: Antal år klar over diskordant status
English: Your doctor will test for these changes.
Danish: Lægen vil teste Dem for at vurdere disse ændringer.
English: • Reminders for evaluations/counselling at the initial visit and follow-up.
Danish: • Påmindelser om evaluering/rådgivning ved det indledende besøg og ved opfølgning.
English: • Get tested for HIV regularly.
Danish: • Bliv testet for HIV regelmæssigt.
English: BMD Z scores were not adjusted for height and weight.
Danish: BMD Z-scorerne blev ikke blevet justeret for højde og vægt.
English: • Always take the dose recommended by your doctor.
Danish: • Tag altid den dosis, Deres læge har anbefalet.
English: Component of a multipack, can't be sold separately.
Danish: Komponent af en multipakning: kan ikke sælges separat.
English: These tumours are unlikely to be of relevance to humans.
Danish: Disse tumorer har sandsynligvis ingen relevans for mennesker.
English: Whether such neurological disorders are transient or permanent is currently unknown.
Danish: Hvorvidt sådanne neurologiske forstyrrelser er forbigående eller permanente er p.t. ikke kendt.
English: Patients were followed for a median of 71 weeks and 87 weeks, respectively.
Danish: Patienterne blev gennemsnitligt fulgt i henholdsvis 71 uger og 87 uger.
English: Then take the next dose at your usual time.
Danish: Tag derefter den næste dosis på det sædvanlige tidspunkt.
English: URAI Within 12 Weeks Prior to Screening, mITT Analysis
Danish: URAI inden for 12 uger før screening, mITT-analyse
English: See Table 1.
Danish: Se Tabel 1.
English: ATC code: J05AR03
Danish: ATC-kode: J05AR03
English: Weight and metabolic parameters
Danish: Vægt og metaboliske parametre
English: Not recommended for use in this population.
Danish: Anbefales ikke til denne population.
English:  Tell your doctor if you are taking any of these medicines.
Danish:  Fortæl Deres læge, hvis De tager nogen af disse lægemidler.
English: Subjects were followed for 4,237 person-years.
Danish: Forsøgspersonerne blev fulgt i 4.237 personår.
English: Tests may also show:
Danish: Prøver kan også vise:
English: Wait and take the next dose, preferably with food, at your usual time.
Danish: Vent og tag den næste dosis, helst med mad, på det sædvanlige tidspunkt.
English: NC = not calculated
Danish: IB = ikke beregnet.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden De begynder at tage dette lægemiddel da den indeholder vigtige oplysninger.
English: Antiviral activity in vitro
Danish: Antiviral aktivitet in vitro
English: Additional risk minimisation measures
Danish: Yderligere risikominimerende foranstaltninger
English: The same recommendations apply as in adults (see Co-administration of other medicinal products below).
Danish: Der gælder samme anbefalinger som hos voksne (se under samtidig administration af andre lægemidler nedenfor).
English: URAI = unprotected receptive anal intercourse
Danish: URAI = ubeskyttet receptivt analt samleje
English: Keep the tablet bottle or package with you so that you can easily describe what you have taken.
Danish: Tag tabletbeholderen eller pakken med, så De let kan vise, hvad De har taget.
English: 117 Allée des Parcs, 69 800 Saint Priest, France
Danish: 117 Allée des Parcs, 69 800 Saint Priest, Frankrig
English: The 144 week secondary endpoint data are also presented in Table 4.
Danish: De sekundære endepunkter-data fra uge 144 vises også i Tabel 4.
English: This indicates that active tubular secretion is an important part of the elimination of tenofovir.
Danish: Dette angiver, at aktiv tubulær sekretion udgør en vigtig del af tenofovirs elimination.
English: People who do have HIV must take this medicine in combination with other drugs.
Danish: Personer, der har HIV, skal tage denne medicin sammen med andre lægemidler.
English: Subjects were followed for 7,830 person-years.
Danish: Forsøgspersoner blev fulgt i 7.830 personår.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Danish: Frekvens er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) eller sjælden (≥ 1/10.000 til < 1/1.000).
English: Not recommended because appropriate dose reductions cannot be achieved with the combination tablet.
Danish: Anbefales ikke, fordi der ikke kan opnås passende dosisreduktioner med kombinationstabletten.
English: You do not need to take another tablet if you were sick more than 1 hour after taking this medicine.
Danish: De behøver ikke tage en ny tablet, hvis De kastede op mere end en time efter, De tog dette lægemiddel.
English: Decreases in BMD of hip were significantly greater in this group until 96 weeks.
Danish: Faldet i BMD i hoften var signifikant større i denne gruppe indtil 96 uger.
English: • Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
Danish: • Bliv testet for andre seksuelt overførbare infektioner, såsom syfilis og gonorré.
English: You may require blood tests for several months after stopping treatment.
Danish: Det kan være nødvendigt at få taget blodprøver i flere måneder efter ophør med behandlingen.
English: Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
Danish: 13% af emtricitabindosen blev genfundet i urinen som tre metabolitter.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: hepatic steatosis, hepatitis
Danish: steatosis hepatis, hepatitis
English: It is thought that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det menes, at disse symptomer skyldes en forbedring i kroppens immunforsvar, så kroppen kan bekæmpe infektioner, der kan have været til stede uden tydelige symptomer.
English:  If this applies to you, tell your doctor immediately.
Danish:  Hvis dette gælder for Dem, skal De omgående fortælle Deres læge det.
English: If appropriate, resumption of hepatitis B therapy may be warranted.
Danish: Hvis det er relevant, kan genoptagelse af hepatitis B-behandling være berettiget.
English: allergic reaction
Danish: allergiske reaktioner
English: • Reminder on the importance of strict adherence to the recommended dosing regimen
Danish: • Påmindelse om vigtigheden af streng overholdelse af det anbefalede doseringsregime
English: Opportunistic infections
Danish: Opportunistiske infektioner
English: Interaction not studied.
Danish: Interaktion er ikke undersøgt.
English: • Do not share or re-use needles or other injection or drug equipment.
Danish: • Lad være med at dele eller genbruge nåle og andet injektions- eller lægemiddeludstyr.
English: Mitochondrial dysfunction following exposure in utero
Danish: Mitokondriel dysfunktion efter eksponering in utero
English: The incidence of HIV seroconversion is shown in Table 9.
Danish: Forekomsten af HIV-serokonvertering er vist i Tabel 9.
English: This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Danish: For at sikre at medicinen er fuldt ud effektiv og for at reducere udviklingen af resistens mod behandlingen.
English: The potential risks and benefits associated with co-administration should be considered, particularly in patients at increased risk of renal dysfunction.
Danish: De potentielle risici og fordele forbundet med samtidig administration bør overvejes, specielt hos patienter med øget risiko for renal dysfunktion.
English: You must get tested to make sure that you do not already have HIV infection.
Danish: De skal testes for at sikre, at De ikke allerede har HIV-infektion.
English: • That a multidisciplinary approach is recommended for the management of paediatric patients
Danish: • At der anbefales en multidisciplinær tilgang til behandling af pædiatriske patienter
English: This medicine is not a cure for HIV infection.
Danish: Denne medicin helbreder ikke HIV-infektion.
English: See also under Co-administration of other medicinal products below.
Danish: Se også under Samtidig administration af andre lægemidler nedenfor.
English: However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.
Danish: De kaldes dog begge generelt for NRTI'er, og de virker ved at gribe ind i den normale måde, som et enzym (revers transkriptase) arbejder på, og som er nødvendigt for at virus kan reproducere sig selv.
English: People who are HIV positive can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Personer, der er HIV-positive, kan stadig overføre HIV, når de tager denne medicin, selvom risikoen sænkes ved effektiv antiretroviral behandling.
English: • Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment
Danish: • Anbefalet tidsplan for monitorering af nyrefunktionen under hensyntagen til forekomst eller fravær af yderligere risikofaktorer for nedsat nyrefunktion
English: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Danish: Der var imidlertid ingen øget risiko for frakturer eller evidens for klinisk relevante knogleabnormiteter over 144 uger.
English: Limited clinical study data suggest that the prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response.
Danish: Begrænsede data fra kliniske studier tyder på, at det forlængede doseringsinterval ikke er optimalt og kunne resultere i øget toksicitet og muligvis utilstrækkeligt respons.
English: 32 (9 to 55)
Danish: 32 (9 til 55)
English: • changes to your urine Rare side effects
Danish: • ændringer i urinen Sjældne bivirkninger
English: This medicine should not be given to adolescents with existing kidney problems.
Danish: Dette lægemiddel bør ikke anvendes til unge med eksisterende nyreproblemer.
English: • Provides safety information on adherence, HIV testing, renal, bone and HBV status.
Danish: • Give sikkerhedsoplysninger om adhærens, HIV-testning samt nyre-, knogle- og HBV-status.
English: Both of these active substances are antiretroviral medicines which are used to treat HIV
Danish: Begge disse aktive stoffer er antiretroviral medicin, som anvendes til behandling af HIV-infektion.
English: Do not change the dose unless your doctor tells you to.
Danish: De må ikke ændre Deres dosis, medmindre De har fået besked på det af Deres læge.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Danish: For de børn, hvis mødre har taget NRTI'er i løbet af graviditeten, opvejede fordelen ved beskyttelse mod HIV-risikoen ved bivirkningerne.
English: • If you think you were infected with HIV, tell your doctor straight away.
Danish: • Hvis De mener, at De er blevet smittet med HIV, skal De straks fortælle Deres læge om det.
English: If you get a flu-like illness, it could mean you have recently been infected with HIV.
Danish: Hvis De får en influenzalignende sygdom, kan det betyde, at De for nyligt er blevet smittet med HIV.
English: • interleukin-2 (to treat cancer)
Danish: • interleukin-2 (til behandling af kræft)
English: Co-administration of other medicinal products
Danish: Samtidig administration af andre lægemidler
English: Do not take this medicine to reduce your risk unless you are confirmed to be HIV negative.
Danish: De må ikke tage denne medicin for at nedsætte Deres risiko, medmindre det er bekræftet, at De er HIV-negativ.
English: If you have hepatitis B or C, your doctor will carefully consider the best treatment regimen for you.
Danish: Hvis De har hepatitis B eller C, vil Deres læge nøje overveje, hvilken behandling, der er den bedste for Dem.
English: Clinical data
Danish: Kliniske data
English: • Many HIV tests can miss a recent infection.
Danish: • Mange HIV-test kan have svært ved at måle en nyligt opstået infektion.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på forværret leversygdom hos sådanne patienter, skal det overvejes at afbryde eller seponere behandlingen.
English: Risk Estimate for HIV-1 Protection: Detection Versus No Detection of Tenofovir
Danish: Risikoestimat for HIV-1 beskyttelse: Detektering af versus ingen detektering af tenofovir
English: insomnia, abnormal dreams
Danish: insomnia, unormale drømme
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Danish: For lipider er der i visse tilfælde evidens for en behandlingsrelateret effekt, mens der for vægtøgning ikke er nogen stærk evidens, som relaterer dette til en bestemt behandling.
English: • No virus analysed contained the K65R or K70E mutation.
Danish: • Ingen analyseret virus indeholdt K65R- eller K70E-mutationen.
English: Married to study partner Years living with study partner
Danish: Antal år levet sammen med studiepartner
English: Baseline characteristics are summarised in Table 8.
Danish: Baseline-karakteristika er sammenfattet i Tabel 8.
English: Other effects in children
Danish: Andre bivirkninger hos børn
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Danish: Disse fund påvirker ikke de aktuelle nationale anbefalinger vedrørende antiretroviral behandling hos gravide med henblik på at undgå vertikal HIV-overførsel.
English: • Reminder of factors to help identify individuals at high risk of acquiring HIV-1
Danish: • Påmindelse om faktorer til hjælp til at identificere personer med høj risiko for at få HIV 1
English: • non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Danish: • non-steroide antiinflammatoriske lægemidler (NSAID'er, til at lindre knogle- eller muskelsmerter)
English: Baseline characteristics are summarised in Table 5.
Danish: Baseline-karakteristika er opsummeret i Tabel 5.
English: Use for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status.
Danish: Profylaktisk brug før eksponering hos personer med ukendt eller positiv HIV 1-status.
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Danish: 3 Studiet blev udført med yderligere voxilaprevir 100 mg for at opnå de forventede voxilaprevir-eksponeringer hos HCV-inficerede patienter.
English: Precautions to prevent transmission of HIV by infected individuals should be taken in accordance with national guidelines.
Danish: Træf de nødvendige forholdsregler for at forhindre overførsel af HIV fra inficerede personer i overensstemmelse med nationale retningslinjer.
English: Tell your doctor if you have had kidney disease, or if tests have shown kidney problems.
Danish: Fortæl Deres læge, hvis De har haft en nyresygdom, eller hvis en test har vist, at De har problemer med nyrerne.
English: b Substudy participants received active adherence monitoring, e.g. unannounced home visits and pill counts, and counselling to improve compliance with study drug.
Danish: b Deltagerne i delstudiet modtog aktiv adhærensmonitorering, f.eks. uanmeldt hjemmebesøg og pilletælling, samt rådgivning i at forbedre komplians med studiemedicinen.