FrancophonIA/ELRC3.0 huggingface dataset:
English: - Reminders to adhere to the dosing schedule - Reminder to attend scheduled clinic visits.
Danish: - Påmindelse om at overholde doseringsplanen - Påmindelse om at møde frem til planlagte klinikbesøg.
English: → If this applies to you, tell your doctor immediately.
Danish: → Hvis dette gælder for Dem, skal De omgående fortælle Deres læge det.
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: 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: Transmission of HIV
Danish: Overførsel af HIV
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På den trykte indlægsseddel for lægemidlet skal der anføres navn og adresse på fremstilleren ansvarlig for frigivelsen af den pågældende batch.
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: Both of these active substances are antiretroviral medicines which are used to treat HIV infection.
Danish: Begge disse aktive stoffer er antiretroviral medicin, som anvendes til behandling af hiv-infektion.
English: OPA/Alu/PE+DES/ - Aluminium blisters.
Danish: OPA/Alu/PE+DES/ - Aluminium blistere.
English: Use for pre exposure prophylaxis in individuals with unknown or positive HIV 1 status.
Danish: Profylaktisk brug af før eksponering hos personer med ukendt eller positiv hiv 1-status.
English: Seroconversions / N
Danish: Serokonverteringer / N
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: 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: 3, nephrogenic diabetes insipidus
Danish: 3, nefrogen diabetes insipidus
English: - At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: - på anmodning fra Det Europæiske Lægemiddelagentur; - når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: If you think you were infected with HIV, tell your doctor straight away.
Danish: Hvis De mener, at De blev smittet med HIV, skal De straks fortælle Deres læge om det.
English: P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Danish: P-værdier efter logrank test. P-værdien for URAI henviser til den nulhypotese, at virkningen var forskellig mellem undergruppestrata (URAI, ingen URAI).
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 virkning, mens der for vægtstigning ikke er nogen stærk evidens, som relaterer dette til en bestemt behandling.
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Danish: Som det kunne forventes, forekom stigninger i ASAT og ALAT dog hyppigere hos denne patientpopulation end i den generelle hiv-inficerede population.
English: ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic Response a: Van Elteren Test
Danish: ** p-værdien baseret på Cochran-Mantel-Haenszel-testen stratificeret til CD4-celletal ved baseline TLOVR = Time to Loss of Virologic Response (tiden til tab af virologisk respons) a:
English: Number with Tenofovir Detected/ Total Samples (%)
Danish: Antal med Detekteret Tenofovir/ Samlet Prøveantal (%)
English: Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Danish: Anæmi var almindelig og misfarvning af huden (øget pigmentering) var meget almindelig, når emtricitabin blev administreret til pædiatriske patienter.
English: - No virus analysed contained the K65R or K70E mutation.
Danish: - Ingen analyseret virus indeholdt K65R- eller K70E-mutationen.
English: Race, N (%)
Danish: Køn, N (%)
English: Substudy participants received active adherence monitoring, e.g. unannounced home visits and pill counts, and counselling to improve compliance with study drug.
Danish: Deltagerne i delstudiet modtog aktiv adhærensmonitorering, f.eks. uanmeldt hjemmebesøg og pilletælling, samt rådgivning i at forbedre komplians med studiemedicinen.
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; antivirale midler til behandling af hiv-infektioner, kombinationer.
English: If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the virus to the baby in breast milk.
Danish: Hvis De er en kvinde med hiv, anbefales det, at De ikke ammer for at undgå at overføre virus til barnet via mælken.
English: The incidences of HIV seroconversion overall and in the subset reporting unprotected receptive anal intercourse are shown in Table 6.
Danish: Forekomsten af HIV-serokonvertering samlet set og i den delmængde, som rapporterede ubeskyttet receptivt analt samleje, er vist i Tabel 6.
English: Many HIV tests can miss a recent infection.
Danish: Mange HIV-test kan have svært ved at måle en nyligt opstået infektion.
English: Adults: one tablet each day, whenever possible with food.
Danish: Voksne: En tablet om dagen, så vidt muligt sammen med mad.
English: Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Danish: Efter oral administration er tenofovirs eliminationshalveringstid ca. 12 til 18 timer.
English: Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Danish: Data genereret fra samtidig dosering af ledipasvir/sofosbuvir.
English: Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines to treat HIV infection.
Danish: Autoimmune sygdomme (når immunsystemet angriber sunde væv i kroppen), kan også opstå, efter at De begynder at tage medicin for at behandle hiv-infektion.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med hereditaer galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption bør ikke indtage dette lægemiddel.
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Danish: Dette skyldes dels forbedret sundhedstilstand og livsstil og med hensyn til lipider i blodet undertiden selve hiv-medicinen.
English: If you have taken Emtricitabine/Tenofovir disoproxil Krka during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis De har taget Emtricitabine/Tenofovir disoproxil Krka under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Both emtricitabine and tenofovir have activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus.
Danish: Både emtricitabin og tenofovir har aktivitet, som er specifik mod human immundefekt virus (hiv 1 og hiv 2) og hepatitis B-virus.
English: Relative risk reduction calculated on incident (post-baseline) seroconversion from the double-blind treatment period and through the 8-week follow-up period.
Danish: Relativ risikoreduktion beregnet for hændelsen (post-baseline) serokonvertering fra den dobbeltblinde behandlingsperiode og igennem den otte uger lange opfølgningsperiode.
English: BLISTER (OPA/Alu/PE+DES-Alu FOIL)
Danish: BLISTERE (OPA/Alu/PE+DES-Alu FOLIE)
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Danish: Med hensyn til monitorering af blodlipider og blodglucose henvises til relevante retningslinjer for hiv-behandling.
English: Years living with study partner Years aware of discordant status
Danish: Antal år klar over diskordant status
English: Keep the bottle tightly closed in order to protect from moisture and light.
Danish: Hold tabletbeholderen tæt tillukket for at beskytte mod fugt og lys.
English: → If you notice any of the side effects listed above or if any of the side effects get serious, talk to your doctor or pharmacist.
Danish: → Hvis De bemærker nogen af de ovenfor anførte bivirkninger, eller hvis nogen af bivirkningerne bliver alvorlige, skal De tale med lægen eller apotekspersonalet.
English: renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)
Danish: nyresvigt (akut og kronisk), akut tubulær nekrose, nefritis (herunder akut interstitiel nefritis)
English: Comparisons for active study groups are made versus placebo.
Danish: Grupper med aktiv forsøgsmedicin er sammenlignet med placebo.
English: - Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
Danish: Brug kondom for at reducere kontakten med sæd, vaginalvæsker og blod.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
Danish: Emtricitabins binding in vitro til humane plasmaproteiner var < 4% og uafhængig af koncentrationsområdet på 0,02-200 µg/mL.
English: elevated serum aspartate aminotransferase (AST) and/or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia increased transaminases
Danish: forhøjet serum-aspartataminotransferase (ASAT) og/eller forhøjet serum-alanin-aminotransferase (ALAT), hyperbilirubinæmi forhøjede aminotransferaser
English: If concomitant use with nephrotoxic agents is unavoidable, renal function should be monitored weekly.
Danish: Hvis samtidig brug af med nefrotoksiske lægemidler ikke kan undgås, bør nyrefunktionen monitoreres ugentligt.
English: Following intravenous administration the volume of distribution of emtricitabine and tenofovir was approximately 1.4 L/kg and 800 mL/kg, respectively.
Danish: Efter intravenøs administration blev emtricitabins og tenofovirs fordelingsvolumen vurderet til at være henholdsvis 1,4 l/kg og 800 ml/kg.
English: Additive to synergistic effects were observed in combination studies with protease inhibitors, and with nucleoside and non-nucleoside analogue inhibitors of HIV reverse transcriptase.
Danish: Additive til synergistiske virkninger observeredes i kombinationsstudier med proteasehæmmere og med nukleosid- og non-nukleosid-analoghæmmere af hiv-revers transkriptase.
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Danish: Tenofovir udskilles primært af nyrerne både ved filtration og et aktivt tubulært transportsystem, hvor ca. 70-80% af dosen udskilles uomdannet i urinen efter intravenøs administration.
English: Relative risk reduction calculated for mITT cohort based on incident (post-baseline) seroconversion.
Danish: Relativ risikoreduktion beregnet for mITT-kohorte baseret på hændelsen (post-baseline) serokonvertering.
English: Physicians should refer to current HIV treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Danish: Læger skal henholde sig til gældende retningslinjer for hiv-behandling ved håndtering af hiv-infektion hos patienter med samtidig infektion med hepatitis B-virus (HBV) eller hepatitis C-virus (HCV).
English: Missing doses may increase your risk of getting HIV infection.
Danish: Glemte doser kan øge Deres risiko for at få en HIVinfektion.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion (AIDS) og tidligere tilfælde af opportunistiske infektioner (infektioner, der optræder hos mennesker med et svagt immunforsvar), kan der forekomme tegn og symptomer på inflammation fra tidligere infektioner kort efter, at behandlingen for hiv er startet.
English: Talk to your doctor if you have a history of liver disease, including hepatitis.
Danish: Tal med Deres læge, hvis De tidligere har haft en leversygdom, herunder hepatitis (gulsot).
English: Therefore, the same problems may be seen if Emtricitabine/Tenofovir disoproxil Krka is administered with a third nucleoside analogue.
Danish: De samme problemer kan derfor muligvis optræde, hvis Emtricitabine/Tenofovir disoproxil Krka administreres sammen med en tredje nukleosidanalog.
English: Shelf life after first opening of the bottle: 1 month.
Danish: Holdbarhed efter første åbning af tabletbeholderen: 1 måned.
English: Indigo carmine aluminium lake (E132)
Danish: Indigocarmin aluminiumpigment (E132)
English: - Periodic Safety Update Reports
Danish: - Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/mL) and CD4 counts (233 and 241 cells/mm
Danish: Ved baseline havde de randomiserede grupper nogenlunde samme mediane plasma hiv 1-rna (5,02 og 5,00 log10 kopier/mL) og CD4-tal (233 og 241 celler/mm
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced BMD (rats and dogs).
Danish: Knogletoksicitet blev diagnosticeret som osteomalaci (aber) og nedsat knoglemineraltæthed (BMD) (rotter og hunde).
English: Emtricitabine/Tenofovir disoproxil Krka should only be used in individuals with creatinine clearance (CrCl) <80 mL/min if the potential benefits are considered to outweigh the potential risks.
Danish: Emtricitabine/Tenofovir disoproxil Krka bør kun anvendes hos personer med kreatininclearance (CrCl) <80 ml/min, hvis de potentielle fordele anses for at opveje de potentielle risici.
English: If you are a woman who could get pregnant during treatment with Emtricitabine/Tenofovir disoproxil Krka, you must use an effective method of contraception to avoid becoming pregnant.
Danish: Hvis De er en kvinde, som kunne blive gravid under behandlingen med Emtricitabine/Tenofovir disoproxil Krka, skal De anvende en sikker præventionsmetode for at undgå at blive gravid.
English: The most frequent adverse reaction reported in the emtricitabine/tenofovir disoproxil group in the iPrEx study was headache (1%).
Danish: Den hyppigste bivirkning i emtricitabine/tenofovirdisoproxil-gruppen i iPrExstudiet var hovedpine (1%).
English: Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Danish: Knogleproblemer (giver somme tider anledning til brud) kan også forekomme på grund af skader på tubulære celler i nyrerne (se punkt 4, Bivirkninger).
English: rhabdomyolysis 1, muscular weakness
Danish: rabdomyolyse 1, muskelsvækkelse
English: Mean change from baseline in CD4 cell count (cells/mm p-value
Danish: Middel ændring fra baseline i CD4-celletal (celler/mm p-værdi
English: P-value a, b mITT Analysis
Danish: P-værdi a,
English: Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Danish: Fund ved studier med rotter og aber viste, at der var en stofrelateret reduktion i den intestinale absorption af phosphat med mulig, sekundær reduktion af BMD.
English: Administration of emtricitabine/tenofovir disoproxil with food resulted in a delay of approximately three quarters of an hour in reaching maximum tenofovir concentrations and increases in tenofovir AUC and Cmax of approximately 35% and 15%, respectively, when administered with a high fat or light meal, compared to administration in the fasted state.
Danish: Administration af emtricitabin/tenofovirdisoproxil sammen med mad gav en forsinkelse på cirka tre kvarter i forhold til opnåelse af maksimale tenofovirkoncentration og en forøgelse i tenofovirs AUC og Cmax med henholdsvis ca. 35% og 15%, når det blev administreret sammen med et let måltid eller et måltid med højt fedtindhold, sammenlignet med administration i fastende tilstand.
English: Talk to your doctor if you are intolerant to lactose (see Emtricitabine/Tenofovir disoproxil Krka contains lactose later in this section).
Danish: Tal med Deres læge, hvis De ikke kan tåle lactose (se ”Emtricitabine/Tenofovir disoproxil Krka indeholder lactose” senere i dette afsnit).
English: Table 3: Tabulated summary of adverse reactions associated with tenofovir disoproxil and emtricitabine based on clinical study and post-marketing experience
Danish: Tabel 3: Resumé af bivirkninger forbundet med tenofovirdisoproxil og emtricitabin baseret på erfaringer fra kliniske studier og efter markedsføring
English: The safety profile of emtricitabine and tenofovir disoproxil in this study was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Danish: Emtricitabins og tenofovir disoproxils sikkerhedsprofiler i denne studie svarede til de tidligere erfaringer med disse komponenter, når disse var blevet administreret sammen med andre antiretrovirale stoffer.
English: Maximum emtricitabine and tenofovir concentrations are observed in serum within 0.5 to 3.0 h of dosing in the fasted state.
Danish: Maksimale koncentrationer af emtricitabin og tenofovir ses i serum inden for 0,5 til 3,0 timer efter administration i fastende tilstand.
English: → Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection
Danish: → Hvis De lægger mærke til nye eller usædvanlige symptomer efter behandlingens ophør, skal De omgående oplyse Deres læge herom, især hvis det drejer sig om symptomer, som De normalt ville forbinde med hepatitis B-infektion.
English: If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order blood tests to closely monitor your kidney function.
Danish: Hvis De tager et andet lægemiddel til behandling af hiv-infektion, som kaldes en proteasehæmmer, vil Deres læge muligvis bestille blodprøver for at overvåge nyrefunktionen nøje.
English: Contains also lactose monohydrate.
Danish: Indeholder også lactosemonohydrat.
English: The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV-1 RNA concentrations < 400 copies/mL over 48 weeks.
Danish: De primære virkningsendepunkter i dette studiet var at opnå og vedligeholde bekræftede hiv 1-rna-koncentrationer < 400 kopier/mL i 48 uger.
English: Animal studies do not indicate harmful effects of emtricitabine or tenofovir disoproxil on fertility.
Danish: Dyrestudier indikerer ingen skadelige virkninger af emtricitabin eller tenofovirdisoproxil på fertiliteten.
English: In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/mL.
Danish: Tenofovirs proteinbinding in vitro til plasma- eller serumproteiner var mindre end henholdsvis 0,7 og 7,2% i tenofovirkoncentrationsområdet på 0,01 til 25 µg/mL.
English: The predominant circulating metabolite of sofosbuvir.
Danish: Den primære cirkulerende sofosbuvirmetabolit.
English: Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect.
Danish: Laktatacidose (for meget mælkesyre i blodet) er en sjælden bivirkning, som kan være livstruende.
English: Renal and bone effects in adults
Danish: Indvirkning på nyrer og knogler hos voksne
English: Efficacy was strongly correlated with adherence as assessed by detection of plasma or intracellular drug levels in a case-control study (Table 7).
Danish: Virkning var stærkt korreleret til adhærens, vurderet ud fra påvisning af plasma- eller intracellulære lægemiddelniveauer i et case-kontrol studie (Tabel 7).
English: HIV-1 infected patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Danish: Hiv-1 inficerede patienter med eksisterende leverdysfunktion, herunder kronisk aktiv hepatitis, har en øget hyppighed af leverfunktionsabnormiteter under antiretroviral kombinationsbehandling (CART) og bør monitoreres i henhold til gældende praksis.
English: If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of therapy with Emtricitabine/Tenofovir disoproxil Krka to you and your child.
Danish: Hvis De bliver gravid eller planlægger at blive gravid, skal De kontakte Deres læge for at drøfte de potentielle fordele og risici, som behandling med Emtricitabine/Tenofovir disoproxil Krka indebærer for Dem og Deres barn.
English: p-value
Danish: P-værdi
English: Film-coated tablet for blisters:
Danish: Filmovertrukken tablet for blistere:
English: Emtricitabine/Tenofovir disoproxil Krka should only be used for pre-exposure prophylaxis as part of an overall HIV-1 infection prevention strategy including the use of other HIV-1 prevention measures (e.g. consistent and correct condom use, knowledge of HIV-1 status, regular testing for other sexually transmitted infections).
Danish: Emtricitabine/Tenofovir disoproxil Krka bør kun bruges som profylakse før eksponering i forbindelse med en samlet strategi for forebyggelse af HIV 1-infektion, herunder brug af andre HIV 1forebyggende foranstaltninger (f.eks. konsekvent og korrekt brug af kondom, viden om HIV 1-status, regelmæssig test for andre seksuelt overførte infektioner).
English: In order to optimise the absorption of tenofovir, it is recommended that Emtricitabine/Tenofovir disoproxil Krka should preferably be taken with food.
Danish: For at optimere tenofovirs absorption anbefales det, at Emtricitabine/Tenofovir disoproxil Krka helst tages sammen med mad.
English: Patients infected with HBV who discontinue Emtricitabine/Tenofovir disoproxil Krka should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Danish: Patienter, som er inficeret med HBV, og som seponerer Emtricitabine/Tenofovir disoproxil Krka, bør monitoreres nøje med både klinisk og laboratoriemæssig opfølgning i flere måneder, efter at behandlingen er stoppet.
English: 28 film-coated tablets: EU/1/16/1151/001 84 film-coated tablets: EU/1/16/1151/003
Danish: 28 filmovertrukne tabletter: EU/1/16/1151/001 84 filmovertrukne tabletter: EU/1/16/1151/003
English: Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Tenofovir disoproxil Krka.
Danish: Kend Deres status for hepatitis B virus (HBV)-infektion inden De begynder at tage Emtricitabine/Tenofovir disoproxil Krka.