FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Danish: Studiet blev udført med yderligere voxilaprevir 100 mg for at opnå de forventede voxilaprevireksponeringer hos HCV-inficerede patienter.
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin
Danish: Virkning på medicinindhold Gennemsnitlig ændring (%) i AUC, Cmax, Cmin
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 Hepatitiseksacerbationer ovenfor.
English: • deep, rapid breathing,
Danish: • dyb, hurtig vejrtrækning
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 hiveller HBV-infektion eller begge dele.
English: Romania or
Danish: Rumænien eller
English: Tenofovir can be removed by haemodialysis; the median haemodialysis clearance of tenofovir is 134 ml/min.
Danish: Tenofovir kan fjernes ved hæmodialyse; median hæmodialyse-clearance af tenofovir er 134 ml/min.
English: Renal and bone effects in adult population
Danish: Påvirkning af nyrer og knogler hos den voksne population
English: Tolerability failure (permanent discontinuation of study drug due to a treatment emergent AE)
Danish: Tolerabilitetssvigt (permanent seponering af studiemedicin på grund af en bivirkning, der opstod under behandlingen)
English: The following pack sizes are available:
Danish: Der findes følgende pakningsstørrelser:
English: While taking Tenofovir disoproxil Zentiva you may still develop infections or other illnesses associated with HIV infection.
Danish: Mens du tager Tenofovir disoproxil Zentiva, kan du stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion.
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day with food (for example, a meal or a snack).
Danish: • Unge i alderen 12 til under 18 år, der vejer mindst 35 kg: 1 tablet en gang dagligt med mad (for eksempel et måltid eller et mellemmåltid).
English: Tenofovir is principally eliminated via the kidney.
Danish: Tenofovir elimineres primært via nyrerne.
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: 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: Gender Limited data on the pharmacokinetics of tenofovir in women indicate no major gender effect.
Danish: Køn Begrænset materiale om tenofovirs farmakokinetik hos kvinder angiver ingen større kønseffekt.
English: Total clearance has been estimated to be approximately 230 ml/h/kg (approximately 300 ml/min).
Danish: Total clearance er beregnet til at være ca. 230 ml/t/kg (ca. 300 ml/min).
English: Age Pharmacokinetic studies have not been performed in the elderly (over 65 years of age).
Danish: Alder Der er ikke foretaget farmakokinetiske studier hos ældre (over 65 år).
English: Duration of therapy in adult and adolescent patients with chronic hepatitis B
Danish: Behandlingens varighed for voksne og unge patienter med kronisk hepatitis B
English: Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors,
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; nukleosid og nukleotid reverse transkriptasehæmmere,
English: Among them, 3 patients experienced a clinically meaningful decline in estimated GFR which improved after discontinuation of tenofovir disoproxil.
Danish: Blandt dem oplevede tre patienter en klinisk betydningsfuld reduktion i estimeret GFR, som bedredes efter seponering af tenofovirdisoproxil.
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: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 ml/min/1.73 m2.
Danish: Syv patienter havde en estimeret glomerulær filtreringshastighed (GFR) mellem 70 og 90 ml/min/1,73 m2.
English: If appropriate, resumption of hepatitis B therapy may be warranted.
Danish: Genoptagelse af hepatitis B-behandlingen kan være nødvendig.
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 phytohaemagglutinin-stimulated 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: Before starting treatment, your doctor may order blood tests to assess your kidney function.
Danish: Før du påbegynder behandlingen, kan din læge bestille blodprøver for at bedømme din nyrefunktion.
English: Tenofovir diphosphate is a weak inhibitor of cellular polymerases α, β, and γ.
Danish: Tenofovirdiphosphat er en svag hæmmer af de cellulære polymeraser α, β og γ.
English: In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected by tenofovir and results in low-level reduced susceptibility to tenofovir.
Danish: Desuden er en K70E-substitution i hiv 1-reverse transkriptase blevet selekteret af tenofovir, hvilket fører til en nedsat følsomhed for tenofovir på lavt niveau.
English: Findings in the rat and monkey studies indicated that there was a substancerelated 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 potentiel, sekundær reduktion af BMD.
English: Simulations suggest that the prolonged dose interval using Tenofovir disoproxil Zentiva 245 mg film-coated tablets is not optimal and could result in increased toxicity and possibly inadequate response.
Danish: Simuleringer antyder, at forlænget doseringsinterval med Tenofovir disproxil Zentiva 245 mg filmovertrukne tabletter ikke er optimalt, og at det kan resultere i øget toksicitet og muligt inadækvat respons.
English: NA = Not Applicable a BMD Z-scores only available for a limited set of subjects with matched reference data b Secondary endpoint through week 48
Danish: NA = not applicable - ikke relevant a BMD Z-resultater er kun tilgængelige for et begrænset sæt forsøgspersoner med matchede referencedata b Sekundært endepunkt til og med uge 48
English: Overall, the data derived from this study are too limited to draw any definitive conclusions on the comparison of emtricitabine plus tenofovir disoproxil versus tenofovir disoproxil, (see Table 7 below).
Danish: Samlet er de afledte data fra denne studie for begrænsede til at drage definitive konklusioner om sammenligningen mellem emtricitabin plus tenofovirdisoproxil og tenofovirdisoproxil (se tabel 7 nedenunder).
English: In patients at risk for renal impairment, a more frequent monitoring of renal function is required.
Danish: Hos patienter med risiko for nedsat nyrefunktion er hyppigere monitorering af nyrefunktionen nødvendig.
English: Both treatments produced similar results with regard to histological response (defined as Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis) at week 48 (see Table 3 below).
Danish: Begge behandlinger producerede lignende resultater med hensyn til histologisk respons (defineret som en forbedring af Knodells nekroinflammatoriske score på mindst 2 point uden forværring af Knodells fibrosescore) ved uge 48 (se tabel 3 nedenfor).
English: • Other medicines containing didanosine (for HIV infection): Taking Tenofovir disoproxil Zentiva with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Danish: • Anden medicin, som indeholder didanosin (mod hiv-infektion): Hvis du tager Tenofovir disoproxil Zentiva sammen med anden antiviral medicin, som indeholder didanosin, kan det øge indholdet af didanosin i blodet og reducere CD4-celletallet.
English: • If you are a woman with HIV or HBV do not breast-feed, to avoid passing the virus to the baby in breast milk.
Danish: • Hvis du er en kvinde med hiv eller HBV, må du ikke amme for at undgå at smitte barnet via mælken.
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: Tenofovirdisoproxil 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: HBV antiviral activity in vitro: The in vitro antiviral activity of tenofovir against HBV was assessed in the HepG2 2.2.15 cell line.
Danish: HBV-antiviral aktivitet in vitro: Tenofovirs antivirale aktivitet in vitro over for HBV blev vurderet i cellelinjen HepG2 2.2.15.
English: Stopping treatment with Tenofovir disoproxil Zentiva may reduce the effectiveness of the treatment recommended by your doctor.
Danish: Ophør med Tenofovir disoproxil Zentiva kan nedsætte virkningen af den behandling, som din læge har anbefalet.
English: 1 Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Danish: Data genereret fra samtidig dosering af ledipasvir/sofosbuvir.
English: Serology (%) HBeAg loss/ seroconversion n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Danish: Serologi (%) Tab af HBeAg/ serokonversion n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
English: Treatment discontinuation may also be considered after stable virological suppression is achieved (i.e. for at least 3 years) provided serum ALT and HBV DNA levels are followed regularly after treatment discontinuation to detect any late virological relapse.
Danish: Seponering af behandlingen kan også overvejes, når der er opnået stabil virologisk suppression (dvs. i mindst 3 år), så længe serum-ALAT- og HBV-dna-niveauer følges regelmæssigt efter seponering af behandlingen for at kunne påvise et eventuelt sent virologisk tilbagefald.
English: If no alternative treatment is available, prolonged dose intervals using the 245 mg film-coated tablets may be used as follows:
Danish: Hvis der ikke forefindes alternativ behandling, kan følgende forlængede dosisintervaller med 245 mg filmovertrukne tabletter anvendes:
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 fundet evidens for en behandlingseffekt, mens der ikke er tydelig evidens for relation mellem vægtstigning og en specifik behandling.
English: Tenofovir disoproxil Zentiva is not suitable for the following groups:
Danish: Tenofovir disoproxil Zentiva er ikke egnet til de følgende grupper:
English: Method of administration Tenofovir disoproxil Zentiva tablets should be taken once daily, orally with food.
Danish: Administration Tenofovir disoproxil Zentiva-tabletter skal tages oralt en gang dagligt sammen med mad.
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 tenofovirdisoproxil forebygger risikoen for overførsel af HBV til andre ved seksuel kontakt eller kontaminering af blod.
English: If you notice signs of inflammation or infection, tell your doctor at once.
Danish: Hvis du bemærker tegn på betændelse eller infektion, skal du omgående fortælle din læge det.
English: If you miss a dose of Tenofovir disoproxil Zentiva, work out how long since you should have taken it.
Danish: Hvis du har glemt en dosis af Tenofovir disoproxil Zentiva, skal du finde ud af, hvor lang tid der er gået, siden du skulle have taget den.
English: If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests to monitor your liver function.
Danish: Hvis du tidligere har haft en leversygdom eller en kronisk hepatitis B-infektion, vil sin læge muligvis tage blodprøver for at overvåge din leverfunktion.
English: Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450 mediated interactions involving tenofovir with other medicinal products is low.
Danish: På basis af resultaterne af in vitro-studier og tenofovirs kendte eliminationsvej er risikoen for CYP450medierede interaktioner, hvor tenofovir er involveret sammen med andre lægemidler, lav.
English: Based on these data, it is unlikely that clinically significant interactions involving tenofovir disoproxil and medicinal products metabolised by CYP450 would occur.
Danish: På baggrund af disse data er det usandsynligt, at der skulle forekomme klinisk betydende interaktioner, der involverer tenofovirdisoproxil og lægemidler, der metaboliseres af CYP450.
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 tenofovirdisoproxil til hiv-inficerede patienter absorberes tenofovirdisoproxil hurtigt og omdannes til tenofovir.
English: Tenofovir has been shown to be excreted in human milk.
Danish: Tenofovir udskilles i human mælk.
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: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl
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: In vitroproteinbinding af tenofovir til plasma- eller serumprotein var under henholdsvis 0,7 og 7,2 % gennem tenofovirs koncentrationsområde 0,01 til 25 µg/ml.
English: Therefore, tenofovir disoproxil should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Danish: Derfor bør tenofovirdisoproxil kun bruges, hvis de potentielle fordele ved behandlingen anses for at veje tungere end de potentielle risici.
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Danish: Den orale biotilgængelighed af tenofovir fra tenofovirdisoproxil var ca. 25 % hos fastende patienter.
English: The effects of tenofovir disoproxil in treatment-experienced and treatment-naïve HIV-1 infected adults have been demonstrated in trials of 48 weeks and 144 weeks duration, respectively.
Danish: Den gavnlige effekt af tenofovirdisoproxil hos tidligere behandlede og behandlingsnaive hiv 1-inficerede voksne er blevet påvist i studier af henholdsvis 48 ugers og 144 ugers varighed.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access program (n = 7,319).
Danish: Hyppighedskategorien ‘ikke almindelig' blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret for tenofovirdisoproxil i randomiserede, kontrollerede, kliniske studier og i programmet for forlænget adgang (n = 7.319).
English: Findings in repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use include renal and bone toxicity and a decrease in serum phosphate concentration.
Danish: Resultater fra toksicitetsstudier efter gentagne doser hos rotter, hunde og aber ved eksponeringsniveauer højere end eller lig med kliniske eksponeringsniveauer og med mulig klinisk relevans omfatter nyre- og knogletoksicitet og et fald i serum-phosphat-koncentrationen.
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: In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to tenofovir disoproxil was nausea (5.4%).
Danish: I kliniske studier med HBV-inficerede patienter, var den hyppigst forekommende bivirkning med tenofovirdisoproxil kvalme (5,4 %).
English: 2 years Shelf-life after first opening is 60 days.
Danish: Holdbarhed efter første åbning: 60 dage.
English: At baseline, 57% of patients randomised to tenofovir disoproxil versus 60% of patients randomised to emtricitabine plus tenofovir disoproxil treatment group had previously been treated with lamivudine.
Danish: Ved baseline var 57 % af de patienter, der var randomiseret til behandlingsgruppen med tenofovirdisoproxil, versus 60 % af de patienter, der var randomiseret til behandlingsgruppen med emtricitabin plus tenofovirdisoproxil, tidligere blevet behandlet med lamivudin.
English: Animal studies do not indicate harmful effects of tenofovir disoproxil on fertility.
Danish: Dyrestudier indikerer ingen skadelige virkninger af tenofovirdisoproxil på fertiliteten.
English: Assessment of adverse reactions for tenofovir disoproxil is based on safety data from clinical studies and post-marketing experience.
Danish: Vurderingen af bivirkninger ved tenofovirdisoproxil er baseret på sikkerhedsdata fra kliniske studier og erfaringer efter markedsføring.
English: Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
Danish: Serum-ALAT skal være vedvarende forhøjet i mindst 6 måneder forud for behandling af pædiatriske patienter med kompenseret leversygdom, der skyldes HbeAg-positiv kronisk hepatitis B, og i mindst 12 måneder hos patienter med HbeAg-negativ sygdom.
English: • Not for HBV infected children under 12 years of age.
Danish: • Ikke til HBV-inficerede børn under 12 år.
English: Long-term studies to evaluate the benefit/risk of bitherapy with emtricitabine plus tenofovir disoproxil in HBV monoinfected patients are ongoing.
Danish: Langtidsstudier til evaluering af fordele/risici af samtidig behandling med emtricitabin plus tenofovirdisoproxil hos HBV-monoinficerede patienter er stadig i gang.
English: Genotypic analysis was conducted for 5 subjects in the tenofovir disoproxil arm post week 48.
Danish: Genotypeanalyse blev udført hos 5 forsøgspersoner i tenoforvirdisoproxil-armen efter uge 48.
English: Moreover, at concentrations substantially higher (approximately 300-fold) than those observed in vivo, tenofovir did not inhibit in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation (CYP3A4, CYP2D6, CYP2C9, CYP2E1, or CYP1A1/2).
Danish: Hertil kommer, at ved koncentrationer væsentligt højere (ca. 300 gange) end dem, der sås in vivo, hæmmede tenofovir ikke in vitro-lægemiddelmetabolisering medieret af en hvilken som helst af de vigtige, humane CYP450-isoformer, der er involveret i lægemiddelbiotransformation (CYP3A4, CYP2D6, CYP2C9, CYP2E1 eller CYP1A1/2).
English: If you are older than this and are prescribed Tenofovir disoproxil Zentiva, your doctor will monitor you carefully.
Danish: Hvis du er over 65 år og får ordineret Tenofovir disoproxil Zentiva, vil din læge overvåge dig nøje.
English: Forty-nine of the 51 nucleoside-experienced patients were previously treated with lamivudine.
Danish: Der var 49 ud af de 51 nukleosid-erfarne patienter, der tidligere var blevet behandlet med lamivudin.
English: Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs).
Danish: Tenofovirdiphosphat har en intracellulær halveringstid på 10 timer i aktiverede og 50 timer i hvilende mononukleære celler i perifert blod (peripheral blood mononuclear cells, PBMC'er).
English: The pharmacokinetics of tenofovir were independent of tenofovir disoproxil dose over the dose range 75 to 600 mg and were not affected by repeated dosing at any dose level.
Danish: Tenofovirs farmakokinetik var uafhængig af tenofovirdisoproxildosis gennem dosisområdet 75-600 mg og påvirkedes ikke af gentagen dosering på noget som helst dosisniveau.
English: 2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials or the tenofovir disoproxil expanded access program.
Danish: Denne bivirkning blev identificeret under sikkerhedsovervågningen efter markedsføring, men blev ikke observeret i randomiserede, kontrollerede, kliniske studier eller i programmet for forlænget adgang til tenofovirdisoproxil.
English: Two subjects randomised to tenofovir disoproxil experienced HBsAg loss by Week 240, but not seroconversion to anti-HBs.
Danish: To forsøgspersoner, der var randomiseret til tenofovirdisoproxil, oplevede HBsAg-tab ved uge 240, men ikke serokonversion til anti-HBs.
English: • Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish: • Bemærker du nogle nye eller usædvanlige symptomer efter behandlingens ophør, skal du omgående oplyse din læge herom, især hvis det drejer sig om symptomer, som du normalt ville forbinde med hepatitis B-infektion.
English: • That Tenofovir disoproxil Zentiva may cause a reduction in BMD and the effects of Tenofovir disoproxil Zentiva associated changes in BMD on long term bone health and future fracture risk are currently unknown in adolescent patients
Danish: • At Tenofovir disoproxil Zentiva kan forårsage en reduktion i BMD og virkningerne af ændringer i BMD associeret med Tenofovir disoproxil Zentiva på knoglesundheden på længere sigt og fremtidig frakturrisiko ikke kendes på nuværende tidspunkt hos unge patienter
English: Experience beyond 48 weeks in study GS-US-174-0108
Danish: Erfaring ud over 48 uger i studie GS-US-174-0108