FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic studies have not been performed with tenofovir disoproxil 245 mg tablets in children under 12 years or with renal impairment.
Danish: Der er ikke foretaget farmakokinetiske studier med tenofovir 245 mg tabletter hos børn under 12 år eller børn med nedsat nyrefunktion.
English: HIV antiviral activity in vitro: The concentration of tenofovir required for 50% inhibition (EC50) of the wild-type laboratory strain HIV-1IIIB is 1-6 µmol/l in lymphoid cell lines and 1.1 µmol/l against primary HIV-1 subtype B isolates in PBMCs.
Danish: HIV-antiviral aktivitet in vitro: Den koncentration af tenofovir, der kræves til 50% hæmning (EC50) af laboratorie-vildtypestammen HIV 1IIIB, er 1-6 µmol/l ved lymfoide cellelinier og 1,1 µmol/l mod primære HIV 1 subtype B isolater i PBMC'er.
English: Tenofovir disoproxil Mylan with food and drink Take Tenofovir disoproxil Mylan with food (for example, a meal or a snack).
Danish: Brug af Tenofovir disoproxil Mylan sammen med mad og drikke Tag Tenofovir disoproxil Mylan sammen med mad (for eksempel et måltid eller et mellemmåltid).
English: Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.
Danish: Tenofovirdiphosphat hæmmer HIV 1-reversetranskriptase og HBV-polymerase ved direkte bindingskonkurrence med det naturlige deoxyribonukleotidsubstrat og - efter indføjelse i dna - ved dna-kædeblokering.
English: Consideration should also be given to interrupting treatment with tenofovir disoproxil in adult patients with creatinine clearance decreased to < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Danish: Det bør også overvejes at afbryde behandlingen med tenofovir disoproxil hos voksne patienter med kreatininclearance på < 50 ml/min eller fald i serumphosphat til < 1,0 mg/dl (0,32 mmol/l).
English: Tenofovir disoproxil Mylan may affect your kidneys during treatment.
Danish: Tenofovir disoproxil Mylan kan have indvirkning på Deres nyrer under behandlingen.
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: Some adult patients with HIV taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle af de voksne HIV-patienter, der får antiretroviral kombinationsbehandling, kan udvikle en knoglesygdom, der kaldes knoglenekrose (knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: Reduced doses of tenofovir disoproxil are used for treatment of HIV-1 infected paediatric patients aged 2 to < 12 years.
Danish: Der anvendes reducerede doser af tenofovir disoproxil til behandling af HIV-1-inficerede pædiatriske patienter i alderen 2 til < 12 år.
English: Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients Adequate dose adjustments cannot be applied due to lack of alternative tablet strengths, therefore use in this group of patients is not recommended.
Danish: Svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) og hæmodialyse-patienter Doseringerne kan ikke justeres tilstrækkeligt, da der ikke er andre tabletstyrker tilgængelige, og derfor kan en justering ikke anbefales i denne patientgruppe.
English: In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil-treated patients.
Danish: I studier med nukleosid-naive patienter forekom der efter behandlingsstart stigninger i ALAT > 10 gange ULN (øvre grænse af normalværdien) og > 2 gange baseline hos 2,6% af de tenofovir disoproxil-behandlede patienter.
English: Table 2: Tabulated summary of adverse reactions associated with tenofovir disoproxil based on clinical study and post-marketing experience Frequency
Danish: Tabel 2: Resumé af bivirkninger forbundet med tenofovir disoproxil baseret på erfaringer fra kliniske studier og efter markedsføring
English: • That Tenofovir disoproxil Mylan is not recommended for use in patients aged 12 to < 18 years with renal impairment
Danish: • At Tenofovir disoproxil Mylan ikke anbefales til patienter i alderen 12 til <18 år med nedsat nyrefunktion
English: Forty-nine of the 51 nucleoside-experienced patients were previously treated with lamivudine.
Danish: Der var 49 ud af de 51 nukleosid-behandlede patienter, der tidligere var blevet behandlet med lamivudin.
English: HIV-1: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg.
Danish: HIV 1: Tenofovir steady-state farmakokinetik blev evalueret hos 8 HIV 1-inficerede unge patienter (i alderen 12 til < 18 år) med kropsvægt ≥ 35 kg.
English: The safety and efficacy of tenofovir disoproxil in HIV-1 infected children under 2 years of age have not been established.
Danish: Tenofovir disoproxils sikkerhed og virkning hos HIV-1 inficerede børn under 2 år er ikke klarlagt.
English: If you think that you may have any of these serious side effects, talk to your doctor.
Danish: Hvis De tror, at De har nogle af disse alvorlige bivirkninger, skal De kontakte Deres læge.
English: Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Danish: Reduktionerne i BMD i rygraden og ændringerne i knoglebiomarkører fra baseline var i uge 144 signifikant større i gruppen, der blev behandlet med tenofovir disoproxil.
English: If you notice any of these symptoms tell your doctor.
Danish: Hvis De bemærker et eller flere af disse symptomer, skal De fortælle det til Deres læge.
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty
Danish: • nyrebetændelse, udskillelse af store mængder urin og en fornemmelse af at være tørstig
English: If you take more Tenofovir disoproxil Mylan than you should If you accidentally take too many Tenofovir disoproxil Mylan tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis De har taget for mange Tenofovir disoproxil Mylan Hvis De ved et uheld tager for mange Tenofovir disoproxil Mylan-tabletter, kan De have en øget risiko for mulige bivirkninger af denne medicin (se pkt.
English: Renal and bone effects in paediatric population
Danish: Påvirkning af nyrer og knogler hos den pædiatriske population
English: The dosing recommendations in patients with renal impairment, with increased dosing interval, are expected to result in higher peak plasma concentrations and lower Cmin levels in patients with renal impairment compared with patients with normal renal function.
Danish: Dosisanbefalingerne til patienter med nedsat nyrefunktion, med øget doseringsinterval, forventes at resultere i højere peakplasmakoncentrationer og lavere Cmin niveauer hos patienter med nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion.
English: No clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with entecavir.
Danish: Der var ingen kliniske signifikante farmakokinetiske interaktioner, når tenofovir disoproxil blev administreret samtidig med entecavir.
English: Look out for signs of inflammation or infection soon after you start taking Tenofovir disoproxil Mylan.
Danish: Hold øje med tegn på betændelse eller infektion i tiden lige efter, De begynder at tage Tenofovir disoproxil Mylan.
English: The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40fold the exposure in patients).
Danish: Knogletoksicitet hos unge voksne rotter og hunde forekom ved eksponeringer ≥ 5 gange eksponeringen hos pædiatriske eller voksne patienter; knogletoksicitet forekom hos unge inficerede aber ved meget høje eksponeringer efter subkutan dosering (≥ 40 gange eksponeringen hos patienter).
English: Mechanism of action and pharmacodynamic effects Tenofovir disoproxil maleate is the maleate salt of the prodrug tenofovir disoproxil.
Danish: Virkningsmekanisme og farmakodynamisk virkning Tenofovir disoproxil maleat er maleatsaltet af et prodrug af tenofovir disoproxil.
English: Multipack: 90 (3 packs of 30) film-coated tablets
Danish: Multipakning: 90 filmovertrukne tabletter (3 pakker af 30)
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 uønskede hændelser (se pkt.
English: Moderate renal impairment (creatinine clearance 30-49 ml/min) Since administration of a lower dose with the 245 mg tablet is not possible, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Danish: Moderat nedsat nyrefunktion (kreatininclearance 30-49 ml/min) Da det ikke er muligt at administrere en lavere dosis med 245 mg tabletten, kan der anvendes forlængede doseringsintervaller med 245 mg tabletten.
English: There are uncertainties associated with the long term effects of bone and renal toxicity.
Danish: Der er usikkerheder i forbindelse med virkningen af langvarig behandling på knogle- og nyretoksicitet.
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: • That use of Tenofovir disoproxil Mylan should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Danish: • At brugen af Tenofovir disoproxil Mylan bør undgås med samtidig eller nylig brug af nefrotoksiske lægemidler.
English: However, administration of tenofovir disoproxil with a light meal did not have a significant effect on the pharmacokinetics of tenofovir.
Danish: Administration af tenofovir disoproxil sammen med et let måltid havde derimod ingen signifikant indvirkning på tenofovirs farmakokinetik.
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Hos HIV-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af CART opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 10 or 30 film coated tablets.
Danish: OPA/aluminium/PE/tørremiddel/PE- Aluminiumblisterpakninger indeholdende 10 eller 30 filmovertrukne tabletter.
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-scores faldt med -0,012 for columna lumbalis og med -0,338 for hele kroppen hos de 64 patienter, der blev behandlet med tenofovir disoproxil i 96 uger.
English: Hepatitis B infection
Danish: Hepatitis B-infektion
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: Safety and efficacy data are very limited in liver transplant patients.
Danish: Data om sikkerhed og virkning hos levertransplanterede patienter er meget begrænsede.
English: If tenofovir disoproxil is discontinued in patients with chronic hepatitis B with or without HIV coinfection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Danish: Hvis tenofovir disoproxil 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: Use with certain hepatitis C virus antiviral agents
Danish: Brug sammen med visse antivirale lægemidler mod hepatitis C
English: HIV-1 and hepatitis B:
Danish: HIV 1 og hepatitis B:
English: Tenofovir disoproxil Mylan does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Danish: Tenofovir disoproxil Mylan nedsætter ikke risikoen for at smitte andre med HBV ved seksuel kontakt eller med inficeret blod.
English: The choice of tenofovir disoproxil 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 som behandlingsform til tidligere antiretroviral-behandlede patienter med HIV 1-infektion skal baseres på individuel testning af patienternes virusresistens og/eller deres behandlingsanamnese.
English: Light blue, round, biconvex, film-coated tablets, 12.20 ± 0.20 mm in diameter, debossed with ‘TN245' on one side and ‘M' on other side.
Danish: Lyseblå, runde, bikonvekse, filmovertrukne tabletter, 12,20 ± 0,20 mm i diameter, præget med „TN245“ på den ene side og „M“ på den anden.
English: Tenofovir disoproxil is a water soluble ester prodrug which is rapidly converted in vivo to tenofovir and formaldehyde.
Danish: Tenofovir disoproxil er et vandopløseligt ester-prodrug, som in vivo hurtigt omdannes til tenofovir og formaldehyd.
English: In patients with renal risk factors, the coadministration of tenofovir disoproxil with a boosted protease inhibitor should be carefully evaluated.
Danish: Hos patienter med renale risikofaktorer skal administration af tenofovir disoproxil sammen med en boostet proteasehæmmer evalueres nøje.
English: copies/ml, elevated serum ALT (≥ 2 x ULN) or a history of elevated serum ALT levels in the past 24 months] were treated with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks.
Danish: kopier/ml, forhøjet serum-ALAT (≥ 2 x ULN) eller en anamnese med forhøjede serum-ALAT-niveauer i løbet af de seneste 24 måneder] behandlet med tenofovir disoproxil 245 mg (n = 52) eller placebo (n = 54) i 72 uger.
English: No amino acid substitutions associated with resistance to tenofovir disoproxil were identified in these isolates.
Danish: Der blev ikke identificeret aminosyresubstitutioner forbundet med resistens over for tenofovir disoproxil i disse isolater.
English: (1 subject)
Danish: (1 forsøgsperson)
English: • Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys.
Danish: • Kontakt lægen eller apotekspersonalet hvis De tidligere har haft nyresygdomme, eller hvis undersøgelser har vist, at De har nyreproblemer.
English: Tenofovir disoproxil has not been studied in patients over 65 years of age.
Danish: Tenofovir disoproxil er ikke blevet undersøgt hos patienter over 65 år.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Tenofovir disoproxil Mylan in patients aged 12 to < 18 years are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at ordinere/bruge Tenofovir disoproxil Mylan til patienter i alderen 12 til <18 år forsynes med en uddannelsespakke til læger, der indeholder produktresuméet og en passende uddannelsesbrochure, som beskrevet nedenfor:
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 tenofovir disoproxil i kombination med en ritonavir- eller cobicistat-boostet proteasehæmmer.
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 forsøgspersoner med ALT-normalisering ved uge 192 i tenofovir disoproxil-tenofovir disoproxil-gruppen var 75,8% (25/33) af dem, som var HBeAg-positive ved baseline, og 100,0% (2 af 2 forsøgspersoner) af dem, som var HBeAg-negative ved baseline.
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 tenofovir disoproxil 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 adefovirdipivoxilresistens-mutationer ved baseline.
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Danish: Patienter med risiko for nedsat nyrefunktion (såsom patienter med renale risikofaktorer ved baseline eller fremskreden HIV-sygdom eller patienter, der samtidig fik nefrotoksiske lægemidler) har en øget risiko for at opleve en ufuldstændig bedring af nyrefunktionen, trods seponering af tenofovir disoproxil (se pkt.
English: If tenofovir disoproxil is co-administered with an NSAID, renal function should be monitored adequately.
Danish: Hvis tenofovir disoproxil administreres sammen med et NSAID, skal nyrefunktionen monitoreres på tilstrækkelig vis.
English: 1, muscular weakness
Danish: 1, muskelsvækkelse
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 tenofovir disoproxil, 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: 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 tenofovir disoproxil i op til 240 uger.
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 tenofovir disoproxil var også forbundet med signifikant større andele af patienter med HBV-dna < 400 kopier/ml sammenlignet med behandlingen med 10 mg adefovirdipivoxil.
English: Response to treatment with tenofovir disoproxil was comparable in nucleos(t)ide-naïve (n = 20) and nucleos(t)ideexperienced (n = 32) patients, including lamivudine- resistant patients (n = 6).
Danish: Behandlingsresponset med tenofovir disoproxil var sammenligneligt hos nukleos(t)id-naive (n = 20) og nukleos(t)idbehandlede (n = 32) patienter, herunder lamivudin-resistente patienter (n = 6).
English: • It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Danish: • Det er også vigtigt at fortælle Deres læge det, hvis De får ledipasvir/sofosbuvir, sofosbuvir/velpatasvir eller sofosbuvir/velpatasvir/voxilaprevir til behandling af hepatitis C-infektion.
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 lamivudinog/eller adefovirdipivoxilresistens-mutationer ved baseline.
English: Tenofovir disoproxil Mylan is not usually taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir disoproxil Mylan).
Danish: Tenofovir disoproxil Mylan tages normalt ikke sammen med anden medicin, som kan skade Deres nyrer (se Brug af anden medicin sammen med Tenofovir disoproxil Mylan).
English: In HIV Tenofovir disoproxil Mylan should always be used combined with other medicines to treat HIV infection.
Danish: Tenofovir disoproxil Mylan bør altid anvendes i kombination med anden medicin for at behandle en HIV-infektion.
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: If concomitant use of tenofovir disoproxil and nephrotoxic agents is unavoidable, renal function should be monitored weekly.
Danish: Hvis samtidig brug af tenofovir disoproxil og nefrotoksiske lægemidler er uundgåelig, skal nyrefunktionen monitoreres ugentligt.
English: Studies conducted with other medicinal products There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
Danish: Der var ingen klinisk signifikante farmakokinetiske interaktioner, når tenofovir disoproxil blev administreret sammen med emtricitabin, lamivudin, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir-boostet), methadon, ribavirin, rifampicin, tacrolimus eller hormonantikonceptionsmidlet norgestimat/ethinylestradiol.
English: Tenofovir disoproxil should not be administered concurrently with adefovir dipivoxil (see section 4.4).
Danish: Tenofovir disoproxil bør ikke administreres sideløbende med adefovir dipivoxil (se punkt 4.4).
English: The mean rate of BMD gain was less in the tenofovir disoproxil group compared to the placebo group.
Danish: Den gennemsnitlige hastighed for stigning i BMD var mindre i tenofovir disoproxil-gruppen sammenlignet med placebogruppen.
English: Similar percentages of subjects in the tenofovir disoproxil-tenofovir disoproxil and PLB-tenofovir disoproxil groups (37.5% and 41.7%, respectively) experienced seroconversion to anti-HBe through week 192.
Danish: Lignende procenter af forsøgspersoner i tenofovir disoproxil-tenofovir disoproxil- og PLB-tenofovir disoproxil-grupperne (henholdsvis 37,5% og 41,7%) oplevede anti-HBe-serokonversion til og med uge 192.