FrancophonIA/ELRC3.0 huggingface dataset:
English: • The importance of regular monitoring of renal function during Tenofovir disoproxil Zentiva therapy
Danish: • Vigtigheden af regelmæssig monitorering af nyrefunktionen i løbet af behandling med Tenofovir disoproxil Zentiva
English: At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as > 4% loss).
Danish: Ved uge 48 havde 6 unge i tenofovirdisoproxilgruppen og én ung i placebogruppen signifikant tab i BMD i columna lumbalis (defineret som > 4 % tab).
English: Consequently, the pharmacokinetics of these medicinal products which are secreted by the same renal pathway including transport proteins hOAT 1 and 3 or MRP 4, might be modified if they are co-administered.
Danish: Farmakokinetikken af disse lægemidler, som udskilles via det samme renale system, herunder transportproteinerne (hOAT) 1 og 3 eller MRP 4, kan derfor forandre sig, hvis de administreres samtidig.
English: Forty-two percent (19/45) of patients had at least 6 months of prior lamivudine experience, 20% (9/45) of patients had prior adefovir dipivoxil experience and 9 of 45 patients (20%) had lamivudine and/or adefovir dipivoxil resistance mutations at baseline.
Danish: 42 % (19/45) af patienterne havde mindst 6 måneders tidligere erfaring med lamivudin, 20 % (9/45) af patienterne havde tidligere erfaring med adefovirdipivoxil, og 9 ud af 45 patienter (20 %) havde lamivudin- og/eller adefovirdipivoxilresistens-mutationer ved baseline.
English: Tenofovir disoproxil Zentiva should not be given to adolescents with existing kidney problems.
Danish: Tenofovir disoproxil Zentiva bør ikke gives til unge med eksisterende nyreproblemer.
English: Forty-three percent of patients had baseline viral loads > 100,000 copies/ml and 39% had CD4 cell counts < 200 cells/ml.
Danish: 43 % af patienterne havde en virusmængde ved baseline på > 100.000 kopier/ml og 39 % havde CD4-celletal på < 200 celler/ml.
English: Excipient with known effect: Each tablet contains 214.5 mg lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 214,5 mg lactosemonohydrat.
English: If Tenofovir disoproxil Zentiva is discontinued in patients with chronic hepatitis B with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Danish: Hvis Tenofovir disoproxil Zentiva seponeres hos patienter med kronisk hepatitis B med eller uden samtidig hiv-infektion, skal disse patienter monitoreres tæt for tegn på eksacerbation af hepatitis (se pkt.
English: BMD Z-scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Danish: BMD Z-resultater faldt med -0,012 for columna lumbalis og med -0,338 for hele kroppen hos de 64 patienter, der blev behandlet med tenofovirdisoproxil i 96 uger.
English: A higher risk of renal impairment has been reported in patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor.
Danish: En større risiko for nedsat nyrefunktion er blevet rapporteret hos patienter, der fik tenofovirdisoproxil i kombination med en ritonavir- eller cobicistat-boostet proteasehæmmer.
English: Subjects must have been naïve to tenofovir disoproxil, but could have received interferon based regimens (> 6 months prior to screening) or any other nontenofovir disoproxil containing oral anti-HBV nucleoside/nucleotide therapy (> 16 weeks prior to screening).
Danish: Patienterne skulle være behandlingsnaive med hensyn til tenofovirdisoproxil, men kunne have fået interferon-baserede regimer (> 6 måneder før screening) eller anden oral anti-HBV nukleosid/nukleotid-behandling (> 16 uger før screening), der ikke indeholdt tenofovirdisoproxil.
English: Median HBV DNA reduction from baselinec
Danish: Median HBVDNA reduktion fra baseline c
English: Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Danish: Patienter, som har en leversygdom, inklusive kronisk hepatitis B eller C, og som behandles med antiretroviral medicin, har en forhøjet risiko for at få alvorlige bivirkninger i leveren, som kan være livsfarlige.
English: • Contact your doctor before you restart taking Tenofovir disoproxil Zentiva tablets.
Danish: • Kontakt din læge, før du igen begynder at tage Tenofovir disoproxil Zentiva.
English: HIV-1 and hepatitis B: In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported.
Danish: Hiv 1 og hepatitis B: Hos patienter, der behandles med tenoforvirdisoproxil, er der rapporteret sjældne tilfælde af nedsat nyrefunktion, nyresvigt og ikke almindeligt forekommende hændelser af proksimal renal tubulopati (herunder Fanconis syndrom), som nogle gange kan medføre knogleabnormiteter (i sjældne tilfælde er det rapporteret som medvirkende årsag til frakturer).
English: The bottle contains 30 film-coated tablets and a silica gel desiccant (in a container).
Danish: Tabletbeholderen indeholder 30 filmovertrukne tabletter sammen med et silicagel-tørremiddel (i en separat beholder).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Danish: De hyppigst rapporterede manifestationer er hæmatologiske forstyrrelser (anæmi, neutropeni) og metaboliske forstyrrelser (hyperlaktatæmi, hyperlipasæmi).
English: Response to treatment with tenofovir disoproxil was comparable in nucleos(t)ide-naïve (n = 20) and nucleos(t)ide-experienced (n = 32) patients, including lamivudine- resistant patients (n = 6).
Danish: Behandlingsresponset med tenofovirdisoproxil var sammenligneligt hos nukleos(t)id-naive (n = 20) og nukleos(t)id-erfarne (n = 32) patienter, herunder lamivudin-resistente patienter (n = 6).
English: Reduced doses of tenofovir (the active ingredient of Tenofovir disoproxil Zentiva) are also used for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 2 to < 12 years.
Danish: Der anvendes også lavere doser af tenofovir (den aktive substans i Tenofovir disoproxil Zentiva) til behandling af hiv-1 infektion og kronisk hepatitis B hos pædiatriske patienter i alderen 2 til < 12 år.
English: No clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with entecavir.
Danish: Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovirdisoproxil blev administreret sammen med entecavir.
English: • That Tenofovir disoproxil Zentiva is not recommended for use in paediatric patients with renal impairment
Danish: • At Tenofovir disoproxil Zentiva ikke anbefales til pædiatriske patienter med nedsat nyrefunktion
English: The active substance tenofovir disoproxil phosphate and its main transformation products are persistent in the environment.
Danish: Miljørisikovurdering Det aktive stof tenofovirdisoproxil og dets primære omdannelsesprodukter er persistente i miljøet.
English: • Do not stop any anti-HIV medicines prescribed by your doctor when you start Tenofovir disoproxil Zentiva if you have both HBV and HIV.
Danish: • Du skal fortsætte med at tage al din medicin mod hiv-infektion, som er ordineret af din læge, når du påbegynder behandlingen med Tenofovir disoproxil Zentiva, hvis du har både HBV og hiv.
English: Thirty-one of the 32 nucleos(t)ide-experienced patients had prior lamivudine experience.
Danish: 31 ud af de 32 nukleos(t)id-erfarne patienter havde tidligere erfaring med lamivudin.
English: - compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Danish: − kompenseret leversygdom og tegn på immunaktiv sygdom, dvs. aktiv viral replikation og vedvarende forhøjede ALAT-niveauer i serum eller histologiske tegn på moderat til svær inflammation og/eller fibrose.
English: If you take more Tenofovir disoproxil Zentiva than you should If you accidentally take too many Tenofovir disoproxil Zentiva tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis du har taget for mange Tenofovir disoproxil Zentiva Hvis du ved et uheld tager for mange Tenofovir disoproxil Zentiva-tabletter, kan du have en øget risiko for mulige bivirkninger af denne medicin (se pkt.
English: Tenofovir disoproxil Zentiva may affect your kidneys during treatment.
Danish: Tenofovir disoproxil Zentiva kan have indvirkning på dine nyrer under behandlingen.
English: Paired baseline and week 240 liver biopsy data were available for 331/489 patients who remained in studies GS-US-174-0102 and GS-US-174-0103 at week 240 (see Table 6 below).
Danish: Data for leverbiopsi ved både baseline og uge 240 var tilgængelige for 331/489 patienter, som forblev i studierne GS-US-174-0102 og GS-US-174-0103 ved uge 240 (se tabel 6 nedenfor).
English: Subjects with a high baseline CPT score were at higher risk of developing serious adverse events (see section 4.4).
Danish: Forsøgspersoner med en høj CPT-score ved baseline havde en større risiko for at udvikle alvorlige bivirkninger (se pkt.
English: The choice of Tenofovir disoproxil Zentiva to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients.
Danish: Valget af Tenofovir disoproxil Zentiva som behandlingsform til tidligere antiretroviral-behandlede patienter med hiv 1-infektion skal baseres på individuel testning af patienternes virusresistens og/eller deres behandlingsanamnese.
English: Patients were stratified by baseline HIV-1 RNA and CD4 count.
Danish: Patienter blev stratificeret efter hiv 1-RNA og CD4-tal ved baseline.
English: Liver disease Safety and efficacy data are very limited in liver transplant patients.
Danish: Leversygdom Data om sikkerhed og virkning hos levertransplanterede patienter er meget begrænsede.
English: Treatment with tenofovir disoproxil 245 mg was also associated with significantly greater proportions of patients with HBV DNA < 400 copies/ml, when compared to adefovir dipivoxil 10 mg treatment.
Danish: Behandlingen med 245 mg tenofovirdisoproxil var også forbundet med signifikant større andele af patienter med HBV-DNA < 400 kopier/ml sammenlignet med behandlingen med 10 mg adefovirdipivoxil.
English: Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
Danish: Tenofovir disoproxil Zentiva er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv 1-inficerede voksne.
English: Since tenofovir is primarily eliminated by the kidneys, co-administration of tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion via transport proteins hOAT 1, hOAT 3 or MRP 4 (e.g. cidofovir) may increase serum concentrations of tenofovir and/or the co-administered medicinal products.
Danish: Da tenofovir primært udskilles gennem nyrerne, kan administration af tenofovirdisoproxil samtidig med lægemidler, der reducerer nyrefunktionen eller konkurrerer om aktiv tubulær secernering via transportproteinerne hOAT 1, hOAT 3 eller MRP 4 (f.eks. cidofovir), øge serumkoncentrationerne af tenofovir og/eller de samtidigt administrerede lægemidler.
English: The proportion of subjects with ALT normalization at week 192 in the tenofovir disoproxil-tenofovir disoproxil group was 75.8% (25/33) among those who were HBeAg positive at baseline and 100.0% (2 of 2 subjects) among those who were HBeAg negative at baseline.
Danish: Andelen af patienter med ALAT-normalisering ved uge 192 i tenofovirdisoproxil-tenofovirdisoproxil-gruppen var 75,8 % (25/33) blandt de patienter, som var HBeAgpositive ved baseline, og 100,0 % (2 af 2 patienter) blandt dem, der var HBeAg-negative ved baseline.
English: Complete response (%)a
Danish: Komplet respons (%)
English: Table 5: Efficacy parameters in compensated HBeAg positive patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Danish: Tabel 5: Virkningsparametre hos kompenserede HBeAg-positive patienter ved uge 96, 144, 192, 240, 288 og 384 open-label-behandling
English: The demonstration of benefit of tenofovir disoproxil in compensated and decompensated disease is based on virological, biochemical and serological responses in adults with HBeAg positive and HBeAg negative chronic hepatitis B. Treated patients included those who were treatment-naïve, lamivudine-experienced, adefovir dipivoxil-experienced and patients with lamivudine and/or adefovir dipivoxil resistance mutations at baseline.
Danish: Påvisningen af tenofovirdisoproxils gavnlige effekt på kompenseret og dekompenseret sygdom er baseret på virologisk, biokemisk og serologisk respons hos voksne med HBeAg-positiv og HBeAg-negativ kronisk hepatitis B. Behandlede patienter omfattede behandlingsnaive, lamivudinerfarne og adefovirdipivoxilerfarne patienter samt patienter med lamivudin- og/eller adefovirdipivoxilresistensmutationer ved baseline.
English: Tenofovir disoproxil Zentiva does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Danish: Tenofovir disoproxil Zentiva nedsætter ikke risikoen for at smitte andre med HBV ved seksuel kontakt eller med inficeret blod.
English: In both of these studies tenofovir disoproxil was significantly superior to adefovir dipivoxil for the primary efficacy endpoint of complete response (defined as HBV DNA levels < 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis).
Danish: I begge disse studier var tenofovirdisoproxil signifikant bedre end adefovirdipivoxil med hensyn til det primære virkningsendepunkt, som var komplet respons (defineret som HBV-DNA-niveauer < 400 kopier/ml og en forbedring af Knodells nekroinflammatoriske score på mindst 2 point uden forværring af Knodells fibrosescore).
English: There are limited data on the safety and efficacy of tenofovir disoproxil in adult patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50 - 80 ml/min).
Danish: Der er begrænsede data om sikkerhed og virkning af tenofovirdisoproxil hos voksne patienter med moderat eller svært nedsat nyrefunktion (kreatinincleance < 50 ml/min), og langtidssikkerhedsdata er ikke blevet evalueret for let nedsat nyrefunktion (kreatininclearance 50 - 80 ml/min).
English: Twenty-five percent (14 of 56) of patients in the tenofovir disoproxil group and 24% (7 of 29) of patients in the placebo group achieved HBeAg seroconversion at Week 48.
Danish: 25 % (14 ud af 56) af patienterne i tenofovirdisoproxil-gruppen og 24 % (7 ud af 29) af patienterne i placebogruppen opnåede HbeAg-serokonversion ved uge 48.
English: Tenofovir disoproxil Zentiva is also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Danish: Tenofovir disoproxil Zentiva anvendes også til behandling af kronisk hepatitis B, som er en infektion med HBV (hepatitis B-virus).
English: • That patients should have their baseline renal function assessed prior to initiating Tenofovir disoproxil Zentiva therapy
Danish: • At patienterne bør have deres nyrefunktion ved baseline vurderet, før behandling med Tenofovir disoproxil Zentiva initieres
English: If no alternative treatment is available, the dosing interval must be adjusted and renal function should be closely monitored (see sections 4.2 and 5.2).
Danish: Hvis der ikke findes nogen alternativ behandling, skal doseringsintervallet justeres og nyrefunktionen monitoreres tæt (se pkt.
English: In study GS-US-174-0121, 141 patients with lamivudine resistance substitutions at baseline received tenofovir disoproxil for up to 240 weeks.
Danish: I studie GS-US-174-0121 fik 141 patienter med lamivudinresistens-substitutioner ved baseline tenofovirdisoproxil i op til 240 uger.
English: Adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients There are limited data on the safety and efficacy of tenofovir disoproxil in patients with impaired renal function.
Danish: Voksne patienter med en kreatininclearance < 50 ml/min, herunder hæmodialysepatienter Der er begrænsede data om sikkerhed og virkning af tenofovirdisoproxil hos patienter med nedsat nyrefunktion.
English: It is recommended that the dosing interval for tenofovir disoproxil 245 mg is modified in adult patients with creatinine clearance < 50 ml/min or in patients who already have ESRD and require dialysis (see section 4.2).
Danish: Det anbefales, at doseringsintervallet for 245 mg tenofovirdisoproxil modificeres hos voksne patienter med kreatininclearance < 50 ml/min eller hos patienter, som allerede har ESRD og har behov for dialyse (se pkt.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate.
Danish: - Øvrige indholdsstoffer: - Tabletkerne: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, povidon, magnesiumstearat.
English: Table 1: Interactions between tenofovir disoproxil and other medicinal products
Danish: Tabel 1: Interaktioner mellem tenofovirdisoproxil og andre lægemidler Lægemiddel iht.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Povidon
English: However, administration of tenofovir disoproxil with a light meal did not have a significant effect on the pharmacokinetics of tenofovir.
Danish: Administration af tenofovirdisoproxil sammen med et let måltid havde derimod ingen signifikant indvirkning på tenofovirs farmakokinetik.
English: All patients with normal ALT at baseline and 88% of patients with abnormal ALT at baseline achieved HBV DNA suppression < 400 copies/ml.
Danish: Alle patienter med normal ALAT ved baseline og 88 % af patienterne med unormal ALAT ved baseline opnåede HBV-DNA-suppresion < 400 kopier/ml.
English: Marketing Authorisation Holder Zentiva, k.s.
Danish: Indehaver af markedsføringstilladelsen Zentiva, k.s.
English: In a paediatric study (GS-US-174-0144), genotypic data from paired baseline and on treatment HBV isolates from patients who received tenofovir disoproxil were available for 9 of 10 patients who had plasma HBV DNA > 400 copies/ml.
Danish: I et pædiatrisk studie (GS-US-174-0144) var genotypedata fra parrede HBV-isolater fra baseline og under behandling fra patienter, der fik tenofovirdisoproxil, tilgængelige for 9 ud af 10 patienter, som havde plasma-HBV-dna > 400 kopier/ml.
English: Experience beyond 48 weeks in studies GS-US-174-0102 and GS-US-174-0103
Danish: Erfaring ud over 48 uger i studierne GS-US-174-0102 og GS-US-174-0103
English: No amino acid substitutions associated with resistance to tenofovir disoproxil were identified in these isolates by week 48.
Danish: Der blev ikke identificeret aminosyresubstitutioner forbundet med resistens over for tenofovirdisoproxil i disse isolater ved uge 48.
English: Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg The recommended dose of Tenofovir disoproxil Zentiva for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
Danish: Voksne og unge i alderen 12 til < 18 år, der vejer ≥ 35 kg Den anbefalede dosis af Tenofovir disoproxil Zentiva til behandling af hiv eller til behandling af kronisk hepatitis B er 245 mg (én tablet) en gang dagligt taget oralt sammen med mad.
English: HIV-1: Approximately one third of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil in combination with other antiretroviral agents.
Danish: Hiv 1: Ca. 1/3 af patienterne kan forventes at få bivirkninger i forbindelse med behandling med tenofovirdisoproxil i kombination med andre antiretrovirale midler.
English: Five subjects randomised to emtricitabine plus tenofovir disoproxil experienced HBsAg loss, with 2 of these 5 subjects experiencing seroconversion to anti-HBs.
Danish: 5 forsøgspersoner, der var randomiseret til emtricitabin plus tenofovirdisoproxil, oplevede tab af HbsAg, hvoraf 2 ud af disse 5 forsøgspersoner oplevede serokonversion til anti-HBs.
English: Studies have established the pathway of active tubular secretion of tenofovir to be influx into proximal tubule cell by the human organic anion transporters (hOAT) 1 and 3 and efflux into the urine by the multidrug resistant protein 4 (MRP 4).
Danish: Studier har vist, at tenofovir secerneres aktivt tubulært af human organisk aniontransporter (hOAT) 1 og 3 ind i de proksimale tubulusceller (influx) og ud i urinen (efflux) af det multidrug-resistente protein 4 (MRP 4).
English: (11 subjects)
Danish: (11 patienter)
English: Film-coating: lactose monohydrate, hypromellose, titanium dioxide, triacetin, indigo carmine aluminum lake.
Danish: Filmovertræk: lactosemonohydrat, hypromellose, titandioxid, triacetin, indigotin.
English: If concomitant use of tenofovir disoproxil and nephrotoxic agents is unavoidable, renal function should be monitored weekly.
Danish: Hvis samtidig brug af tenofovirdisoproxil og nefrotoksiske lægemidler er uundgåelig, skal nyrefunktionen monitoreres ugentligt.
English: Other medicines and Tenofovir disoproxil Zentiva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Tenofovir disoproxil Zentiva Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af CART opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: rhabdomyolysis1, muscular weakness1
Danish: rabdomyolyse 1, muskelsvækkelse
English: In patients with renal risk factors, the co-administration of tenofovir disoproxil with a boosted protease inhibitor should be carefully evaluated.
Danish: Hos patienter med renale risikofaktorer skal administration af tenofovirdisoproxil sammen med en boostet proteasehæmmer evalueres nøje.
English: Tenofovir disoproxil Zentiva is not usually taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir disoproxil Zentiva).
Danish: Tenofovir disoproxil Zentiva tages normalt ikke sammen med anden medicin, som kan skade dine nyrer (se Brug af anden medicin sammen med Tenofovir disoproxil Zentiva).
English: If a patient misses a dose of Tenofovir disoproxil Zentiva by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Danish: Hvis en patient glemmer at tage en dosis Tenofovir disoproxil Zentiva i mere end 12 timer, og det næsten er tid til næste dosis, skal patienten ikke tage den manglende dosis, men blot fortsætte med den normale doseringsplan.
English: HIV antibody testing should be offered to all HBV infected patients before initiating tenofovir disoproxil therapy (see below Co-infection with HIV-1 and hepatitis B).
Danish: Alle HBV-inficerede patienter bør tilbydes hiv-antistoftest før start af behandlingen med tenofovirdisoproxil (se Samtidig infektion med hiv 1 og hepatitis B nedenfor).