FrancophonIA/ELRC3.0 huggingface dataset:
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 tenofovir disoproxil og tenofovir disoproxil (se tabel 7 nedenunder).
English: Unless clearly necessary, concomitant use of these medicinal products which are secreted by the same renal pathway is not recommended, but if such use is unavoidable, renal function should be monitored weekly (see section 4.5).
Danish: Medmindre det er klart nødvendigt, anbefales samtidig brug af disse lægemidler, som udskilles via samme renale system, ikke, men hvis samtidig brug er uundgåelig, bør nyrefunktionen monitoreres en gang om ugen (se pkt.
English: You do not have to have HIV to be treated with Tenofovir disoproxil Mylan for HBV.
Danish: De behøver ikke nødvendigvis have HIV for at blive behandlet med Tenofovir disoproxil Mylan for HBV.
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: 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 tenofovir disoproxil og lægemidler, der metaboliseres af CYP450.
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 tenofovir disoproxil hos HBV-monoinficerede patienter er stadig i gang.
English: Therefore, tenofovir disoproxil should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Danish: Derfor bør tenofovir disoproxil kun bruges, hvis de potentielle fordele ved behandlingen anses for at veje tungere end de potentielle risici.
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 vitro-proteinbinding af tenofovir til plasma- eller serumprotein var under henholdsvis 0,7 og 7,2% gennem tenofovirs koncentrationsområde 0,01 til 25 µg/ml.
English: • headache, stomach pain, feeling tired, feeling bloated, flatulence Tests may also show:
Danish: • diarré, opkastning, kvalme, svimmelhed, udslæt, svaghedsfølelse Prøver kan også vise:
English: Study 174-0103 (HBeAg positive)
Danish: Studie 174-0103 (HBeAg-positiv)
English: 10 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets
Danish: 10 filmovertrukne tabletter 30 filmovertrukne tabletter 30×1 filmovertrukne tabletter
English: However, in some patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Danish: Hos nogle patienter gik reduktionen i kreatininclearance imidlertid ikke helt væk, trods seponering af tenofovir disoproxil.
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 De er en kvinde med HIV eller HBV, må De ikke amme for at undgå at smitte barnet via mælken.
English: Mylan Hungary Kft Mylan utca 1, Komarom, H-2900, Hungary
Danish: Mylan Hungary Kft Mylan utca 1, Komarom, H-2900, Ungarn
English: Animal studies do not indicate harmful effects of tenofovir disoproxil on fertility.
Danish: Dyrestudier indikerer ingen skadelige virkninger af tenofovir disoproxil på fertiliteten.
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 points uden forværring af Knodells fibrosescore) ved uge 48 (se tabel 3 nedenfor).
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 tenofovir disoproxil er baseret på sikkerhedsdata fra kliniske studier og erfaringer efter markedsføring.
English: Although there are limited clinical data on the use of tenofovir disoproxil in pregnant women, it is not usually used unless absolutely necessary.
Danish: Selvom der foreligger begrænsede kliniske data om brug af Tenofovir disoproxil Mylan hos gravide, anvendes Tenofovir disoproxil Mylan normalt ikke, medmindre det er absolut nødvendigt.
English: Cumulatively, there were 4 patients who experienced a viremic episode (HBV DNA>400 copies/ml) at their last timepoint on tenofovir disoproxil.
Danish: Kumulativt var der 4 patienter, som oplevede en viræmisk episode (HBV-dna > 400 kopier/ml) på det sidste tidspunkt på tenofovir disoproxil.
English: Resistance: No HBV mutations associated with tenofovir disoproxil resistance have been identified (see Clinical efficacy and safety).
Danish: Resistens: Der er ikke blevet identificeret nogle HBV-mutationer med relation til tenofovir disoproxilresistens (se Klinisk virkning og sikkerhed).
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 CYP450-medierede interaktioner, hvor tenofovir er involveret sammen med andre lægemidler, lav.
English: • Other medicines containing didanosine (for HIV infection): Taking Tenofovir disoproxil Mylan 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 De tager Tenofovir disoproxil Mylan sammen med anden antiviral medicin, som indeholder didanosin, kan det øge indholdet af didanosin i blodet og reducere CD4-celletallet.
English: Histology
Danish: Histologi
English: Simulations suggest that the prolonged dose interval using tenofovir disoproxil 245 mg film-coated tablets is not optimal and could result in increased toxicity and possibly inadequate response.
Danish: Simuleringer antyder, at tenofovir disoproxil 245 mg filmovertrukne tabletter med forlænget doseringsinterval ikke er optimalt, og at det kan resultere i øget toksicitet og muligt inadækvat respons.
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 tenofovir disoproxil hos tidligere behandlede og behandlingsnaive HIV 1-inficerede voksne er blevet påvist i studier af henholdsvis 48 ugers og 144 ugers varighed.
English: • That Tenofovir disoproxil Mylan may cause a reduction in BMD and the effects of Tenofovir disoproxil Mylan associated changes in BMD on long term bone health and future fracture risk are currently unknown in patients aged 12 to < 18 years.
Danish: • At Tenofovir disoproxil Mylan kan forårsage en reduktion i BMD og virkningerne af ændringer i BMD associeret med Tenofovir disoproxil Mylan på knoglesundheden på længere sigt og fremtidig frakturrisiko ikke kendes på nuværende tidspunkt hos patienter i alderen 12 til <18 år
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Danish: Den orale biotilgængelighed af tenofovir fra tenofovir disoproxil var ca. 25% hos fastende patienter.
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Danish: Under HIV-behandling kan der forekomme vægtstigning samt forhøjede niveauer af lipider og glukose i blodet.
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 De tidligere har haft en leversygdom eller en kronisk hepatitis B-infektion, vil Deres læge muligvis tage blodprøver for at overvåge Deres leverfunktion.
English: In study GS-99-907, 550 treatment-experienced adult patients were treated with placebo or tenofovir disoproxil 245 mg for 24 weeks.
Danish: I studie GS-99-907 blev 550 behandlingserfarne voksne patienter behandlet med placebo eller 245 mg tenofovir disoproxil i 24 uger.
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 tenofovir disoproxil, versus 60% af de patienter, der var randomiseret til behandlingsgruppen med emtricitabin plus tenofovir disoproxil, tidligere blevet behandlet med lamivudin.
English: • changes to your urine and back pain caused by kidney problems, including kidney failure
Danish: • ændringer i urinen og rygsmerter på grund af nyreproblemer, inklusive nyresvigt
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 tenofovir disoproxil i randomiserede, kontrollerede, kliniske studier og i programmet for forlænget adgang (n=7.319).
English: • Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish: • Bemærker De nogle 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: Tenofovir disoproxil Mylan should not be given to adolescents with existing kidney problems.
Danish: Tenofovir disoproxil Mylan bør ikke gives til unge med eksisterende nyreproblemer.
English: Baseline genotypic analysis of HIV isolates from 253 patients revealed that 94% of patients had HIV-1 resistance mutations associated with nucleoside reverse transcriptase inhibitors, 58% had mutations associated with protease inhibitors and 48% had mutations associated with non-nucleoside reverse transcriptase inhibitors.
Danish: Genotypeanalyse ved baseline af HIV-isolater fra 253 patienter afslørede, at 94% af patienterne havde HIV 1-resistensmutationer i forbindelse med nukleosid reverse transkriptasehæmmere, 58% havde mutationer i forbindelse med proteasehæmmere og 48% havde mutationer i forbindelse med non-nukleosid reverse transkriptasehæmmere.
English: • aminoglycosides, pentamidine or vancomycin (for bacterial infection),
Danish: • aminoglykosider, pentamidin eller vancomycin (mod bakteriel infektion),
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 tenofovir disoproxil-dosis gennem dosisområdet 75-600 mg og påvirkedes ikke af gentagen dosering på noget som helst dosisniveau.
English: Tenofovir disoproxil must be taken with food, as food enhances the bioavailability of tenofovir (see section 5.2).
Danish: Tenofovir disoproxil skal tages sammen med mad, da mad forbedrer tenofovirs biotilgængelighed (se pkt.
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 tenofovir disoproxil, oplevede HBsAg-tab ved uge 240, men ikke serokonversion til anti-HBs.
English: Given that tacrolimus can affect renal function, close monitoring is recommended when it is coadministered with tenofovir disoproxil.
Danish: Da tacrolimus kan påvirke nyrefunktionen, anbefales tæt monitorering, når det administreres samtidigt med tenofovir disoproxil.
English: Co-infection with hepatitis C or D: There are no data on the efficacy of tenofovir in patients coinfected with hepatitis C or D virus.
Danish: Samtidig infektion med hepatitis C eller D: Der findes ingen data om virkningen af tenofovir hos patienter med samtidig infektion med hepatitis C- eller D-virus.
English: The safety and efficacy of tenofovir disoproxil in children with chronic hepatitis B aged 2 to < 12 years or weighing < 35 kg have not been established.
Danish: Tenofovir disoproxils sikkerhed og virkning hos børn med kronisk hepatitis B i alderen 2 til < 12 år, eller som vejer < 35 kg er ikke klarlagt.
English: Median HBV DNA reduction from baseline c
Danish: Median HBV-dnareduktion fra baselinec
English: HBsAg loss/ seroconversion n/a n/a n/a n/a n/a n/a
Danish: HBeAg/serokonversion n/a n/a
English: The EC50 values for tenofovir were in the range of 0.14 to 1.5 µmol/l, with CC50 (50% cytotoxicity concentration) values > 100 µmol/l.
Danish: EC50-værdierne for tenofovir var inden for intervallet 0,14 til 1,5 µmol/l med CC50-værdier (50% cytotoksisk koncentration) > 100 µmol/l.
English: Of the 94 patients with cirrhosis at baseline (Ishak fibrosis score 5-6), 26% (24) experienced no change in Ishak fibrosis score and 72% (68) experienced regression of cirrhosis by week 240 with a reduction in Ishak fibrosis score of at least 2 points.
Danish: Ud af 94 patienter med cirrose ved baseline (Ishaks fibrosescore: 5 - 6) oplevede 26% (24) ingen ændring i Ishaks fibrosescore, og 72% (68) oplevede regression af cirrose ved uge 240 med en reduktion i Ishaks fibrosescore på mindst 2 points.
English: Tenofovir shows activity in vitro against HIV-2, with an EC50 of 4.9 µmol/l in MT-4 cells.
Danish: Tenofovir er desuden aktivt in vitro mod HIV 2 med en EC50 på 4,9 µmol/l ved MT-4-celler.
English: MYLAN S.A.S 117 Allée des Parcs 69800 Saint-Priest France
Danish: MYLAN S.A.S 117 Allée des Parcs 69800 Saint-Priest Frankrig
English: If you are older than this and are prescribed Tenofovir disoproxil Mylan, your doctor will monitor you carefully.
Danish: Hvis De er over 65 år og får ordineret Tenofovir disoproxil Mylan, vil Deres læge overvåge Dem nøje.
English: Proximal renal tubulopathy generally resolved or improved after tenofovir disoproxil discontinuation.
Danish: Proksimal renal tubulopati gik generelt væk eller blev bedre efter seponering af tenofovir disoproxil.
English: Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
Danish: På grund af begrænsninger i studiet blev der ikke vist en gavnlig effekt ved tenofovir disoproxil sammenlignet med placebo baseret på plasma-HIV 1-rnaniveauer ved uge 24.
English: Study 174-0102 (HBeAg negative)
Danish: Studie 174-0102 (HBeAg-negativ)
English: Do not take Tenofovir disoproxil Mylan together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Danish: Tag ikke Tenofovir disoproxil Mylan sammen med medicin, der indeholder adefovirdipivoxil (medicin, der anvendes til at behandle kronisk hepatitis B).
English: Co-infection with HIV-1 and hepatitis B: Due to the risk of development of HIV resistance, tenofovir disoproxil should only be used as part of an appropriate antiretroviral combination regimen in HIV/HBV co-infected patients.
Danish: Samtidig infektion med HIV 1 og hepatitis B: På grund af risikoen for udvikling af HIV-resistens skal tenofovir disoproxil kun anvendes som en del af en passende, antiretroviral kombinationsbehandling hos patienter med samtidig HIV/HBV-infektion.
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2, Tenofovir disoproxil Mylan contains lactose), hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132).
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, lactosemonohydrat (se punkt 2, Tenofovir disoproxil Mylan indeholder lactose) hydroxypropylcellulose, vandfri kolloid silica, magnesiumstearat, hypromellose, titandioxid (E171), triacetin, indigotin aluminiumpigment (E132).
English: However, in exceptional circumstances Tenofovir disoproxil Mylan 245 mg film-coated tablets can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice.
Danish: I særlige tilfælde kan Tenofovir disoproxil Mylan 245 mg filmovertrukne tabletter imidlertid administreres, efter tabletten er blevet opløst i mindst 100 ml vand, appelsinjuice eller druesaft.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with tenofovir disoproxil in one or more subsets of the paediatric population in HIV and chronic hepatitis B (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med tenofovir disoproxil i en eller flere undergrupper af den pædiatriske population med HIV og kronisk hepatitis B (se pkt.
English: Normal ALT ≥ 2 point decrease in CPT from baseline n (%)
Danish: ALAT n (%) Normal ALAT ≥ 2 point reduktion i CPT fra baseline n (%)
English: Severe renal impairment: 245 mg tenofovir disoproxil may be administered every 72-96 hours (dosing twice a week).
Danish: Svært nedsat nyrefunktion: 245 mg tenofovir disoproxil kan administreres hver 72.-96. time (dosering to gange ugentlig).
English: Mean (± SD) Cmax and AUCtau are 0.38 ± 0.13 μg/ml and 3.39 ± 1.22 μg·h/ml, respectively.
Danish: Gennemsnitlig (± SD) Cmax og AUCtau er henholdsvis 0,38 ± 0,13 μg/ml og 3,39 ± 1,22 μg·t/ml.
English: 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: 2 Denne bivirkning blev identificeret under sikkerhedsovervågningen efter markedsføring, men blev ikke observeret i randomiserede, kontrollerede, kliniske studier eller i programmet for forlænget adgang til tenofovir disoproxil.
English: Approximately 1% of tenofovir disoproxil -treated adult patients discontinued treatment due to the gastrointestinal events.
Danish: Ca. 1% af de tenofovir disoproxil-behandlede voksne patienter ophørte med behandlingen på grund af gastrointestinale symptomer.
English: Ninety-five percent (225/237) of patients without cirrhosis at baseline and 99% (93/94) of patients with cirrhosis at baseline had either no change or an improvement in fibrosis (Ishak fibrosis score).
Danish: 95% (225/237) af patienterne uden cirrose ved baseline og 99% (93/94) af patienterne med cirrose ved baseline havde enten ingen ændring eller en bedring af fibrosen (Ishaks fibrosescore).
English: Hepatitis B: Approximately one quarter of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil, most of which are mild.
Danish: Hepatitis B: Ca. 1/4 af patienterne kan forventes at få bivirkninger i forbindelse med behandling med tenofovir disoproxil; de fleste af dem er lette.
English: Danmark BGP Products ApS Tlf: + 45 28116932
Danish: BGP Products ApS Tlf: + 45 28116932
English: However, tenofovir disoproxil reduced the viability index and weight of pups in peripostnatal toxicity studies at maternally toxic doses.
Danish: Tenofovir disoproxil reducerede imidlertid afkommets levedygtighed og vægt i peri-postnatale toksicitetsstudier ved doser, der var toksiske for moderen.
English: • That there is an increased risk of renal disease in HIV and HBV infected patients associated with tenofovir disoproxil-containing products such as Tenofovir disoproxil Mylan
Danish: • At der er en øget risiko for nyresygdom hos HIV- og HBV-inficerede patienter forbundet med tenofovir disoproxil-indeholdende præparater, såsom Tenofovir disoproxil Mylan
English: After oral administration of tenofovir disoproxil, tenofovir is distributed to most tissues with the highest concentrations occurring in the kidney, liver and the intestinal contents (preclinical studies).
Danish: Efter oral administration af tenofovir disoproxil fordeles tenofovir til de fleste væv, hvor de højeste koncentrationer forekommer i nyrer, lever og tarmindhold (prækliniske studier).
English: Stopping treatment with Tenofovir disoproxil Mylan may reduce the effectiveness of the treatment recommended by your doctor.
Danish: Ophør med Tenofovir disoproxil Mylankan nedsætte virkningen af den behandling, som Deres læge har anbefalet.
English: Based upon Long Term Evaluation algorithm (LTE Analysis) - Patients who discontinued the study at any time prior to week 384 due to a protocol defined endpoint, as well as those completing week 384, are included in the denominator.
Danish: 11l a Baseret på Long Term Evaluation algoritme (LTE-analyse) - Patienter, som afbrød studiet på et vilkårligt tidspunkt før uge 384 pga. et protokoldefineret endepunkt, såvel som dem, der fuldførte uge 384, inkluderes i nævneren.
English: Confirmed increase in serum creatinine ≥ 0.5 mg/dl from baseline or confirmed serum phosphate of < 2 mg/dl n (%)
Danish: Bekræftet forhøjelse af serumkreatinin ≥ 0,5 mg/dl fra baseline eller bekræftet serumphosphat på < 2 mg/dl n (%)b
English: There are limited clinical data with respect to the effect of tenofovir disoproxil on fertility.
Danish: Der er begrænsede kliniske data hvad angår virkningen af tenofovir disoproxil på fertilitet.
English: However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil.
Danish: Patienter bør dog underrettes om, at svimmelhed er blevet indberettet som en bivirkning under behandling med tenofovir disoproxil.
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 tenofovir disoproxil (se Samtidig infektion med HIV 1 og hepatitis B nedenfor).
English: Results through 48 weeks from two randomised, phase 3 double-blind studies comparing tenofovir disoproxil to adefovir dipivoxil in adult patients with compensated liver disease are presented in Table 3 below.
Danish: Resultater gennem 48 uger fra to randomiserede, dobbeltblinde fase 3-studier, som sammenlignede tenofovir disoproxil med adefovirdipivoxil hos voksne patienter med kompenseret leversygdom, vises i tabel 3 nedenfor.
English: The results indicate that patients whose HIV expressed 3 or more thymidine-analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced response to tenofovir disoproxil 245 mg therapy.
Danish: Resultaterne indikerer, at patienter, hvis HIV udtrykte 3 eller flere thymidin-analog-forbundne mutationer (TAMs), som omfattede enten M41L- eller L210W-reverse transkriptase-mutation, viste reduceret respons over for behandlingen med 245 mg tenofovir disoproxil.
English: HBeAg loss/ seroconversion
Danish: HBeAg/serokonversion
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 tenofovir disoproxil-gruppen og én ung i placebogruppen signifikant tab i BMD i columna lumbalis (defineret som > 4% tab).