FrancophonIA/ELRC3.0 huggingface dataset:
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: • Adults: 1 tablet each day with food (for example, a meal or a snack).
Danish: • Voksne: 1 tablet en gang dagligt med mad (for eksempel et måltid eller et mellemmåltid).
English: • interleukin-2 (to treat cancer),
Danish: • interleukin-2 (til behandling af kræft),
English: k One patient in this group became HBsAg negative for the first time at the 240 week visit and was ongoing in the study at the time of the data cut-off.
Danish: k Én patient i denne gruppe blev HBsAg-negativ for første gang ved uge 240-besøget og var stadig i studiet på skæringsdagen for dataindsamling.
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
Danish: Hyppighederne 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: Complete response a
Danish: Komplet respons a
English: medicines which are no longer fully effective due to development of resistance, or have caused side effects.
Danish: der ikke længere er helt effektivt på grund af udvikling af resistens, eller der forårsagede bivirkninger.
English: Following oral administration the terminal half-life of tenofovir is approximately 12 to 18 hours.
Danish: Efter oral administration er den terminale halveringstid af tenofovir ca. 12 til 18 timer.
English: If this medicine has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”).
Danish: Hvis Tenofovir disoproxil Mylan er ordineret til Deres barn, bedes De bemærke, at alle oplysninger i indlægssedlen er henvendt til Deres barn (i dette tilfælde bedes De læse „Deres barn“ i stedet for „De“).
English: • If it is more than 12 hours since you should have taken it, forget about the missed dose.
Danish: • Hvis det er mere end 12 timer siden De skulle have taget den, skal De ikke tage den glemte dosis.
English: • If you have taken Tenofovir disoproxil Mylan 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 Tenofovir disoproxil Mylan under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Possible serious side effects: tell your doctor immediately
Danish: Alvorlige bivirkninger: Kontakt Deres læge omgående
English: Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Danish: En eksacerbation efter behandlingen er normalt forbundet med stigning i HBV-dna, og størstedelen af tilfældene forekommer at være selvbegrænsende.
English: Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
Danish: Deres læge vil nøje tage stilling til, om det er nødvendigt at behandle Dem med kombinationer af tenofovir og didanosin.
English: The active substance tenofovir disoproxil and its main transformation products are persistent in the environment.
Danish: Det aktive stof tenofovir disoproxil og dets primære omdannelsesprodukter er persistente i miljøet.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: De kan stadig smitte andre med HIV, selvom De tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: The tablets are also available in blister packs containing 10, 30 or 30 x 1 (unit dose) tablets.
Danish: Tabletterne fås også i blisterpakninger, som indeholder 10, 30 eller 30 × 1 (enkeltdosis) tabletter.
English: You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
Danish: De kan også smitte med HIV og HBV, så det er vigtigt at tage forholdsregler for at undgå at smitte andre.
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, at leversygdommen forværres hos sådanne patienter, skal man overveje at afbryde eller foretage et ophold i behandlingen.
English: Other suitable formulations may be checked for their availability.
Danish: Det kan undersøges, om der findes andre egnede formuleringer.
English: Serology (%)
Danish: Serologi (%)
English: One patient in the tenofovir disoproxil arm developed the K70E substitution in the virus.
Danish: En patient i armen med tenofovir disoproxil udviklede K70E-substitutionen i virusset.
English: • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy 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 Deres antiretrovirale behandling indebærer for Dem og Deres barn.
English: • If it is less than 12 hours after it is usually taken, take it as soon as you can, and then take your next dose at its regular time.
Danish: • Hvis det er mindre end 12 timer efter, dosis normalt tages, skal De tage den så hurtigt som muligt og derefter tage den næste dosis på det normale tidspunkt.
English: • deep, rapid breathing
Danish: • dyb, hurtig vejrtrækning
English: Reductions in BMD have been observed in HBV infected adolescents.
Danish: Reduktioner i BMD er blevet observeret hos HBV-inficerede unge.
English: Tenofovir is also active against HIV-1 subtypes A, C, D, E, F, G, and O and against HIVBaL in primary monocyte/macrophage cells.
Danish: Tenofovir er også aktivt mod HIV 1-subtyperne A, C, D, E, F, G og O og mod HIVBaL ved primære monocyt-/makrofagceller.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og pakningen efter (EXP).
English: Your doctor may order blood tests during treatment to monitor how your kidneys work.
Danish: Deres læge kan bestille blodprøver under behandlingen for at overvåge, hvordan Deres nyrer fungerer.
English: The optimal duration of treatment is currently unknown.
Danish: Behandlingens optimale varighed er aktuelt ukendt.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter De er begyndt at tage medicin til behandling af Deres HIV-infektion.
English: • non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains).
Danish: • non-steroide antiinflammatoriske midler (NSAID'er, til at lindre knogle- eller muskelsmerter).
English: The K65R mutation occurred in a slightly higher percentage of patients in the tenofovir disoproxil group than the active control group (2.7% versus 0.7%).
Danish: K65R-mutationen sås hos en lidt højere procentdel af patienter i tenofovir disoproxil gruppen end den aktive kontrolgruppe (2,7% versus 0,7%).
English: This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV infection or both.
Danish: Dette aktive stof er en form for medicin, der kaldes antiretroviral eller antiviral medicin, som anvendes til behandling af enten HIV- eller HBV-infektion eller begge dele.
English: • You must not take Tenofovir disoproxil Mylan during pregnancy unless specifically discussed with your doctor.
Danish: • De må ikke tage Tenofovir disoproxil Mylan under graviditeten, medmindre De specifikt har drøftet dette med Deres læge.
English: Store in the original package in order to protect from light and moisture.
Danish: Opbevares i den originale pakning for at beskytte mod lys og fugt.
English: Entecavir (0.5 mg or 1 mg) n = 22
Danish: Entecavir (0,5 mg eller 1 mg) n = 22
English: Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF07.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; nukleosid og nukleotid reverse transkriptasehæmmere, ATC-kode: J05AF07
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil.
Danish: En stor mængde data fra gravide kvinder (mere end 1.000 graviditetsudfald) indikerer ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med tenofovir disoproxil.
English: At weeks 96, 144, 192, 240, 288 and 384 viral suppression, biochemical and serological responses were maintained with continued tenofovir disoproxil treatment (see Tables 4 and 5 below).
Danish: Ved uge 96, 144, 192, 240, 288 og 384 blev viral suppression og biokemisk og serologisk respons opretholdt ved fortsat tenofovir disoproxil-behandling (se tabel 4 og 5 nedenfor).
English: Do not reduce the prescribed dose, unless your doctor has told you to do so.
Danish: Tag ikke mindre end den ordinerede dosis, medmindre Deres læge har sagt, at De skal gøre det.
English: Median change from baseline HBV DNA merely reflects the difference between baseline HBV DNA and the limit of detection (LOD) of the assay.
Danish: c Median ændring fra baseline HBV-dna reflekterer blot forskellen mellem baseline HBV-dna og analysens detektionsgrænse (Limit of detection - LOD).
English: Interactions between tenofovir disoproxil and other medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”, and once daily as “q.d.”).
Danish: Interaktioner mellem tenofovir disoproxil og andre lægemidler ses i tabel 1 nedenfor (stigning er angivet som „↑“, fald som „↓“, ingen ændring som „↔“, to gange dagligt som „b.i.d.“, en gang dagligt som „q.d.“).
English: In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Danish: Hos patienter med kompenseret leversygdom er disse stigninger i serum-ALAT generelt hverken ledsaget af en stigning i serum-bilirubinkoncentrationen eller af hepatisk dekompensation.
English: In vitro studies have determined that neither tenofovir disoproxil nor tenofovir are substrates for the CYP450 enzymes.
Danish: In vitro-studier har afgjort, at hverken tenofovir disoproxil eller tenofovir er substrater for CYP450enzymerne.
English: Comparisons between treatment groups beyond week 24 are difficult to interpret since investigators had the option to intensify treatment to open-label emtricitabine plus tenofovir disoproxil.
Danish: Sammenligninger mellem behandlingsgrupperne ud over uge 24 er svære at fortolke, da investigatorerne havde muligheden for at intensivere behandlingen til open-label-behandling med emtricitabin plus tenofovir disoproxil.
English: INNER CARTON OF MULTIPACK AND BOTTLE LABEL (WITHOUT BLUE BOX)
Danish: INDERKARTON AF MULTIPAKNING OG FLASKEETIKET (UDEN BLÅ BOKS)
English: Oral use Read the package leaflet before use.
Danish: Til oral anvendelse Læs indlægssedlen inden brug.
English: If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Tenofovir disoproxil Mylan is started.
Danish: Hvis De har en fremskreden HIV-infektion (aids) og har en infektion, kan De udvikle symptomer på infektion og betændelse eller opleve en forværring af symptomerne på en eksisterende infektion, når behandlingen med Tenofovir disoproxil Mylan påbegyndes.
English: Tenofovir disoproxil Mylan tablets should be taken once daily, orally with food.
Danish: Tenofovir disoproxil Mylan-tabletter skal tages oralt en gang dagligt sammen med mad.
English: • adefovir dipivoxil (for HBV),
Danish: • adefovirdipivoxil (mod HBV),
English: Indigo carmine aluminium lake (E132)
Danish: Indigocarmin-aluminiumpigment (E132)
English: The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil.
Danish: De bivirkninger, der blev observeret ved fortsat behandling i 384 uger, var i overensstemmelse med sikkerhedsprofilen for tenofovir disoproxil.
English: At concentrations of up to 300 µmol/l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays.
Danish: Ved koncentrationer på op til 300 µmol/l har tenofovir tilmed ikke vist effekt på syntesen af mitokondrie-dna eller produktionen af mælkesyre ved in vitro-analyser.
English: At week 72, 96% (27/28) of immune-active patients (HBV DNA ≥ 10
Danish: Ved uge 72 havde 96% (27/28) af de immunaktive patienter (HBV-dna ≥ 10
English: • That a multidisciplinary approach is recommended for the management of patients aged 12 to < 18 years
Danish: • At der anbefales en multidisciplinær fremgangsmåde for behandlingen af patienter i alderen 12 til <18 år
English: Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Danish: En opblussen af leversygdommen er særdeles alvorlig og nogle gange letal hos patienter med dekompenseret leversygdom.
English: Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B.
Danish: Behandlingen skal initieres af en læge med erfaring i behandlingen af HIV-infektion og/eller behandling af kronisk hepatitis B.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Danish: Tilfælde af osteonekrose er rapporteret, specielt hos patienter med generelt anerkendte risikofaktorer, fremskreden HIV-sygdom eller langvarig CART.
English: • If you are an adult and have problems with your kidneys, your doctor may advise you to take Tenofovir disoproxil Mylan less frequently.
Danish: • Hvis De er voksen og har problemer med Deres nyrer, kan Deres læge råde Dem til at tage Tenofovir disoproxil Mylan mindre hyppigt.
English: The difference in the proportion of patients who maintained < 400 copies/ml at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil treatment group.
Danish: Forskellen i andelen af patienter, der bibeholdte < 400 kopier/ml ved uge 48 var hovedsageligt påvirket af det højere antal seponeringer i behandlingsgruppen med tenofovir disoproxil.
English: From both the genotypic and phenotypic analyses there was no evidence for other pathways of resistance to tenofovir.
Danish: Fra både genotypeog fænotypeanalyser har der ikke været nogle tegn på andre veje for resistens over for tenofovir.
English: If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Tenofovir disoproxil Mylan treatment without talking to your doctor first.
Danish: Hvis De har hepatitis B eller både HIV og hepatitis B samtidig (co-infektion), er det meget vigtigt, at De ikke ophører med behandlingen med Tenofovir disoproxil Mylan uden først at tale med Deres læge.
English: Administration of tenofovir disoproxil with a high fat meal enhanced the oral bioavailability, with an increase in tenofovir AUC by approximately 40% and Cmax by approximately 14%.
Danish: Administration af tenofovir disoproxil sammen med et fedtholdigt måltid forstærkede den orale biotilgængelighed med en forøgelse i tenofovir AUC med ca. 40% og Cmax med ca. 14%.
English: • HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Danish: • HIV-inficerede unge i alderen 12 til under 18 år, som vejer mindst 35 kg og som allerede er blevet behandlet med anden HIV-medicin, der ikke længere er helt effektivt på grund af udvikling af resistens, eller der forårsagede bivirkninger
English: If this applies to you, tell your doctor immediately and do not take Tenofovir disoproxil Mylan.
Danish: Hvis dette gælder for Dem, skal De omgående fortælle Deres læge det og lade være med at tage Tenofovir disoproxil Mylan.
English: While taking Tenofovir disoproxil Mylan you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens De tager Tenofovir disoproxil Mylan, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med HIV-infektion.
English: The bottles also contain desiccant.
Danish: Flaskerne indeholder også tørremiddel.
English: The HIV and HBV patients aged 12 to < 18 years educational brochures should contain the following key messages:
Danish: HIV- og HBV-patienter i alderen 12 til <18 år uddannelsesbrochurer bør indeholde de følgende nøglebeskeder:
English: d The population used for analysis of ALT normalisation included only patients with ALT above ULN at baseline.
Danish: d Populationen, som blev brugt til analyse af ALAT-normalisering, inkluderede kun patienter med ALAT over ULN ved baseline.
English: However, it should be noted that increases of ALT can be part of HBV clearance during therapy with tenofovir, see above Exacerbations of hepatitis.
Danish: Det skal imidlertid bemærkes, at stigninger i ALAT kan være en del af HBV-clearance under behandling med tenofovir, se Hepatitis-eksacerbationer ovenfor.
English: • Talk to your doctor before you stop taking Tenofovir disoproxil Mylan for any reason, particularly if you are experiencing any side effects or you have another illness.
Danish: • Tal med Deres læge, før De holder op med at tage Tenofovir disoproxil Mylan, uanset årsagen, især hvis De oplever bivirkninger eller har en anden sygdom.
English: (2 subjects)
Danish: (2 forsøgspersoner)
English: • Not for HIV-1 infected children under 12 years of age
Danish: • Ikke til HIV 1-inficerede børn under 12 år
English: It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition.
Danish: Den anses ikke som årsagsmæssigt forbundet med tenofovir disoproxil, hvis denne tilstand ikke er til stede.
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCVinfected patients.
Danish: 3 Studiet blev udført med yderligere voxilaprevir 100 mg for at opnå de forventede voxilaprevir-eksponeringer hos HCV-inficerede patienter.
English: Table 6: Histological response (%) in compensated HBeAg negative and HBeAg positive subjects at week 240 compared to baseline
Danish: Tabel 6: Histologisk respons (%) hos kompenserede HBeAg-negative og HBeAg-positive forsøgspersoner ved uge 240 sammenlignet med baseline
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping tenofovir disoproxil.
Danish: Nogle patienter har symptomer på, eller deres blodprøver viser, at deres hepatitis er blevet forværret efter ophør med behandlingen med tenofovir disoproxil.
English: In non-proliferating human peripheral blood mononuclear cells (PBMCs) the half-life of tenofovir diphosphate was found to be approximately 50 hours, whereas the half-life in phytohaemagglutininstimulated PBMCs was found to be approximately 10 hours.
Danish: I ikke-proliferende mononukleære celler i humant perifert blod (PBMC'er) konstateredes det, at tenofovirdiphosphats halveringstid var ca. 50 timer, hvorimod halveringstiden i phytohæmagglutininstimulerede PBMC'er var ca. 10 timer.
English: Data pertaining to HIV
Danish: Data vedrørende HIV
English: • amphotericin B (for fungal infection),
Danish: • amphotericin B (mod svampeinfektion),
English: Before starting treatment, your doctor may order blood tests to assess your kidney function.
Danish: Før De påbegynder behandlingen, kan Deres læge bestille blodprøver for at bedømme Deres nyrefunktion.
English: Among them, 3 patients experienced a clinically meaningful decline in estimated GFR which improved after discontinuation of tenofovir disoproxil.
Danish: Blandt dem oplevede 3 patienter en klinisk betydningsfuld reduktion i estimeret GFR, som bedredes efter seponering af tenofovir disoproxil.
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Danish: I andre studier (prospektive studier og tværsnitsstudier) sås de mest udtalte reduktioner i BMD hos patienter, der blev behandlet med tenofovir disoproxil som del af et regime indeholdende en boostet proteasehæmmer.
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 ved både filtrering og et aktivt tubulært transportsystem, hvor ca. 70-80% af dosen udskilles uomdannet i urinen efter intravenøs administration.
English: • foscarnet, ganciclovir, or cidofovir (for viral infection),
Danish: • foscarnet, ganciclovir eller cidofovir (mod virusinfektion),
English: Resistance: Strains of HIV-1 with reduced susceptibility to tenofovir and a K65R mutation in reverse transcriptase have been selected in vitro and in some patients (see Clinical efficacy and safety).
Danish: Resistens: Stammer af HIV 1 med nedsat følsomhed over for tenofovir og en K65R-mutation ved reverse transkriptase er blevet udsøgt in vitro og hos nogle patienter (se Klinisk virkning og sikkerhed).
English: • adolescents aged 12 to less than 18 years who have already been treated with other HIV
Danish: • unge i alderen 12 til under 18 år, som allerede er blevet behandlet med anden HIV-medicin,
English: Patients must be advised that tenofovir disoproxil has not been proven to prevent the risk of transmission of HBV to others through sexual contact or contamination with blood.
Danish: Patienterne skal underrettes om, at det ikke er påvist, at tenofovir disoproxil forebygger risikoen for overførsel af HBV til andre ved seksuel kontakt eller kontaminering af blod.
English: Tenofovir disoproxil at a concentration of 100 µmol/l had no effect on any of the CYP450 isoforms, except CYP1A1/2, where a small (6%) but statistically significant reduction in metabolism of CYP1A1/2 substrate was observed.
Danish: Tenofovir disoproxil i en koncentration på 100 µmol/l havde ingen effekt på nogen af CYP450-isoformerne undtagen CYP1A1/2, hvor der sås en lille (6%), men statistisk signifikant reduktion i metaboliseringen af CYP1A1/2-substrat.
English: Mylan Hungary Kft Mylan utca 1, Komarom, 2900, Hungary
Danish: Mylan Hungary Kft Mylan utca 1, Komarom, 2900, Ungarn
English: If you notice signs of inflammation or infection, tell your doctor at once.
Danish: Hvis De bemærker tegn på betændelse eller infektion, skal De omgående fortælle Deres læge det.
English: acute renal failure, renal failure, acute tubular necrosis, nephritis (including acute interstitial nephritis)
Danish: akut nyresvigt, nyresvigt, akut tubulær nekrose, nefritis (herunder akut interstitiel nefritis)
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Danish: 7 patienter havde en estimeret glomerulær filtreringshastighed (GFR) mellem 70 og 90 ml/min/1,73 m2.
English: Following oral administration of tenofovir disoproxil to HIV infected patients, tenofovir disoproxil is rapidly absorbed and converted to tenofovir.
Danish: Efter oral administration af tenofovir disoproxil til HIV-inficerede patienter absorberes tenofovir disoproxil hurtigt og omdannes til tenofovir.