FrancophonIA/ELRC3.0 huggingface dataset:
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Danish: Ældre Der foreligger ingen data, hvorpå der kan laves en dosisanbefaling til patienter over 65 år (se pkt.
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any adolescent patient receiving tenofovir disoproxil, renal function should be re-evaluated within one week.
Danish: • At hvis serumphosphat bekræftes til at være < 3,0 mg/dl (0,96 mmol/l) hos unge patienter, der får tenofovirdisoproxilfumarat, skal vurderingen af nyrefunktionen gentages inden for en uge.
English: Use of tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product (e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2).
Danish: Brug af tenofovirdisoproxil bør undgås med samtidig eller nylig brug af et nefrotoksisk lægemiddel (f.eks. aminoglykosider, amphotericin B, foscarnet, ganciclovir, pentamidin, vancomycin, cidofovir eller interleukin-2).
English: Thirteen percent (6/45) of the tenofovir disoproxil group, 13% (6/45) of the emtricitabine plus tenofovir disoproxil group, and 9% (2/22) of the entecavir group had a confirmed increase in serum creatinine ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl.
Danish: 13 % (6/45) i tenofovirdisoproxil-gruppen, 13 % (6/45) i emtricitabin plus tenofovirdisoproxil-gruppen og 9 % (2/22) i entecavir-gruppen havde en bekræftet stigning i serumkreatinin på ≥ 0,5 mg/dl eller bekræftet serumphosphat på < 2 mg/dl.
English: Renal safety with tenofovir disoproxil has only been studied to a very limited degree in adult patients with impaired renal function (creatinine clearance < 80 ml/min).
Danish: Tenofovirdisoproxils renale sikkerhed er kun blevet undersøgt i et meget begrænset omfang hos voksne patienter med nedsat nyrefunktion (kreatininclearance < 80 ml/min).
English: If you forget to take Tenofovir disoproxil Zentiva It is important not to miss a dose of Tenofovir disoproxil Zentiva.
Danish: Hvis du har glemt at tage Tenofovir disoproxil Zentiva Det er vigtigt, at du husker at tage hver dosis af Tenofovir disoproxil Zentiva.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 filmovertrukne tabletter.
English: Tenofovir disoproxil has not been clinically evaluated in patients receiving medicinal products which are secreted by the same renal pathway, including the transport proteins human organic anion transporter (hOAT) 1 and 3 or MRP 4 (e.g. cidofovir, a known nephrotoxic medicinal product).
Danish: Tenofovirdisoproxil er ikke klinisk vurderet hos patienter, der får lægemidler, som udskilles via det samme renale system, herunder transportproteinerne human organic anion transporter (hOAT) 1 og 3 eller MRP 4 (f.eks. cidofovir, et lægemiddel, der er kendt for at virke nefrotoksisk).
English: Eight patients had HIV that expressed K65R in the tenofovir disoproxil 245 mg arm, 7 of these occurred during the first 48 weeks of treatment and the last one at week 96.
Danish: 8 patienter i 245 mg tenofovirdisoproxil-armen havde hiv med K65R-mutation, 7 af disse opstod i løbet af de første 48 uger af behandlingen og den sidste i uge 96.
English: Film-coated tablet
Danish: Filmovertrukket tablet.
English: Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Danish: Samtidig administration af tenofovirdisoproxil og didanosin ved en dosis på 400 mg dagligt er blevet sat i forbindelse med en signifikant reduktion af CD4-celletallet, muligvis på grund af en intracellulær interaktion, der forhøjer niveauet af phosphoryleret (dvs. aktiv) didanosin.
English: In study GS-US-174-0103 a significantly greater proportion of patients in the tenofovir disoproxil group than in the adefovir dipivoxil group had normalised ALT and achieved HBsAg loss at week 48 (see Table 3 below).
Danish: I studie GS-US-174-0103 var der en signifikant større andel af patienterne i tenofovirdisoproxil-gruppen, der havde normaliseret ALAT og opnået tab af HBsAg ved uge 48 end i adefovirdipivoxil-gruppen (se tabel 3 nedenfor).
English: A consistent response to treatment with tenofovir disoproxil 245 mg was seen regardless of baseline HIV-1 RNA and CD4 count.
Danish: En konsistent respons på behandling med 245 mg tenofovirdisoproxil sås uden hensyn til hiv 1-RNA og CD4-tal ved baseline.
English: The co-primary safety endpoints were discontinuation due to an adverse event and confirmed increase in serum creatinine ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl.
Danish: De sammensatte primære sikkerhedsendepunkter var seponering på grund af en bivirkning og en bekræftet forhøjelse af serumkreatinin ≥ 0,5 mg/dl eller bekræftet serumphosphat på < 2 mg/dl.
English: Viruses containing the rtA181T mutation remained susceptible to tenofovir with EC50 values 1.5-fold that of wild-type virus.
Danish: Virus, som indeholdt rtA181T-mutatationen, forblev følsomme over for tenofovir med EC50-værdier på 1,5 gange den for vildtypevirus.
English: Tenofovir disoproxil Zentiva is a treatment for HIV (Human Immunodeficiency Virus) infection.
Danish: Tenofovir disoproxil Zentiva anvendes til behandling af infektion med hiv (humant immundefektvirus).
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 Cinfektion.
English: Eight (2%) tenofovir disoproxil 245 mg (treated patients developed the K65R mutation within the first 48 weeks.
Danish: 8 patienter (2 %) behandlet med 245 mg tenofovirdisoproxil udviklede K65R mutationen inden for de første 48 uger.
English: Exacerbations of hepatitis after discontinuation of treatment In HBV infected patients, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of HBV therapy (see section 4.4).
Danish: Hepatitis-eksacerbationer efter seponering af behandling Hos HBV-inficerede patienter er der forekommet klinisk og laboratoriemæssig evidens for hepatitiseksacerbationer efter seponering af HBV-behandling (se pkt.
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 tenofovirdisoproxilbehandlede patienter.
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 tenofovirdisoproxilgruppen sammenlignet med placebogruppen.
English: Interrupting treatment with Tenofovir disoproxil Zentiva should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: Det bør også overvejes at afbryde behandlingen med Tenofovir disoproxil Zentiva i tilfælde af progressiv forværring af nyrefunktionen, når der ikke er identificeret andre årsager.
English: Subjects must have been naïve to tenofovir disoproxil, with HBV DNA > 105 copies/ml (~ 4.2 log10 IU/ml) and ALT > 1.5 × the upper limit of normal (ULN) at screening.
Danish: Forsøgspersonerne skulle være tenofovirdisoproxil-naive, have HBV-dna > 105 kopier/ml (~ 4,2 log10 IE/ml) og ALAT på > 1,5 × den øvre grænse af normalværdien (ULN) ved screening.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Danish: Hos patienter med tidligere tilfælde af leverdysfunktion, herunder kronisk aktiv hepatitis, er der en forhøjet forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling (CART) og disse patienter bør monitoreres i henhold til standardprocedurer.
English: Table 4: Efficacy parameters in compensated HBeAg negative patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Danish: Tabel 4: Virkningsparametre hos kompenserede HBeAg-negative patienter ved uge 96, 144, 192, 240, 288 og 384 open-label-behandling
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients aged 2 to < 12 years in clinical study GS-US-104-0352 (see sections 4.8 and 5.1).
Danish: Nyrebivirkninger i overensstemmelse med proximal renal tubulopati er blevet rapporteret hos hiv-inficerede, pædiatriske patienter i alderen 2 til < 12 år i det kliniske studie GS-US-104-0352 (se pkt.
English: Tenofovir disoproxil is a water soluble ester prodrug which is rapidly converted in vivo to tenofovir and formaldehyde.
Danish: Tenofovirdisoproxil er et vandopløseligt ester-prodrug, som in vivo hurtigt omdannes til tenofovir og formaldehyd.
English: If Tenofovir disoproxil Zentiva is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule
Danish: Hvis Tenofovir disoproxil Zentiva bruges samtidig med nefrotoksiske lægemidler, skal nyrefunktionen nøje monitoreres i henhold til det anbefalede skema.
English: Study GS-US-174-0103 was conducted in 266 (randomised and treated) HBeAg positive patients while study GS-US-174-0102 was conducted in 375 (randomised and treated) patients negative for HBeAg and positive for HBeAb.
Danish: Studie GS-US-174-0103 blev udført med 266 (randomiserede og behandlede) HBeAgpositive patienter, mens studie GS-US-174-0102 blev udført med 375 (randomiserede og behandlede) patienter, som var HBeAg-negative og HBeAb-positive.
English: b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis score.
Danish: b Forbedring af Knodells nekroinflammatoriske score på mindst 2 point uden forværring af Knodells fibrosescore.
English: Among them, sequence data from paired baseline and on treatment HBV isolates were available for 2 of 4 patients.
Danish: Blandt dem var sekvensdata tilgængelige fra parrede HBV-isolater fra baseline og under behandling for 2 ud af 4 patienter.
English: Response to treatment with tenofovir disoproxil was comparable in nucleoside-experienced (n = 51) and nucleoside-naïve (n = 375) patients and in patients with normal ALT (n = 21) and abnormal ALT (n = 405) at baseline when studies GS-US-174-0102 and GS-US-174-0103 were combined.
Danish: Behandlingsresponset med tenofovirdisoproxil var sammenlignelig hos de nukleosid-erfarne (n = 51) og nukleosid-naive (n = 375) patienter samt hos patienter med normal ALAT (n = 21) og unormal ALAT (n = 405) ved baseline, da studierne GS-US-174-0102 og GS-US-174-0103 blev kombineret.
English: Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:
Danish: Tenofovir disoproxil Zentiva er indiceret til behandling af kronisk hepatitis B hos unge i alderen 12 til < 18 år, der har:
English: HBV DNA n (%) < 400 copies/ml n (%)
Danish: HBV-DNA n (%) < 400 kopier/ml n (%) ALAT n (%)
English: In study GS-US-174-0108, 45 patients (including 9 patients with lamivudine and/or adefovir dipivoxil resistance mutations at baseline) received tenofovir disoproxil for up to 168 weeks.
Danish: I studie GS-US-174-0108 fik 45 patienter (herunder 9 patienter med lamivudin- og/eller adefovirdipivoxilresistens-mutationer ved baseline) tenofovirdisoproxil i op til 168 uger.
English: Oblong-shaped, light blue colored film-coated tablets with dimensions approx. 17.2 x 8.2 mm.
Danish: Aflang, lyseblå filmovertrukket tablet, der måler ca. 17,2 x 8,2 mm.
English: • Do not take Tenofovir disoproxil Zentiva if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide.
Danish: • Tag ikke Tenofovir disoproxil Zentiva, hvis du allerede tager anden medicin, der indeholder tenofovirdisoproxil eller tenofoviralafenamid.
English: In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).
Danish: Hos voksne er påvisningen af tenofovirdisoproxil gavnlige effekt på hiv 1-infektion baseret på resultaterne fra ét studie med behandlingsnaive patienter, herunder patienter med en høj virusmængde (> 100.000 kopier/ml) og studier, hvor tenofovirdisoproxil blev føjet til stabil baggrundsterapi (hovedsagelig trestofsbehandling) hos antiretroviralt forbehandlede patienter, som tidligt ikke havde haft virologisk effekt (< 10.000 kopier/ml; hos størstedelen af patienterne < 5.000 kopier/ml).
English: Outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Danish: Pakning indeholdende 1 tabletbeholder med 30 filmovertrukne tabletter og pakning indeholdende 90 (3 tabletbeholdere med hver 30) filmovertrukne tabletter.
English: In HIV Tenofovir disoproxil Zentiva should always be used combined with other medicines to treat HIV infection.
Danish: Tenofovir disoproxil Zentiva bør altid anvendes i kombination med anden medicin for at behandle en hiv-infektion.
English: Therefore, in adult patients with renal impairment tenofovir disoproxil should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Danish: Tenofovirdisoproxil bør derfor kun bruges til voksne patienter med nedsat nyrefunktion, hvis de potentielle fordele ved behandlingen anses for at veje tungere end de potentielle risici.
English: The pharmacokinetics of tenofovir in paediatric patients with renal impairment have not been studied.
Danish: Tenofovirs farmakokinetik hos pædiatriske patienter med nedsat nyrefunktion er ikke undersøgt.
English: Clinical studies in treatment-experienced patients have assessed the anti-HIV activity of tenofovir disoproxil 245 mg against strains of HIV-1 with resistance to nucleoside inhibitors.
Danish: Kliniske studier med tidligere behandlede patienter har vurderet anti-hiv-aktiviteten af 245 mg tenofovirdisoproxil mod hiv 1-stammer med resistens over for nukleosidhæmmere.
English: ALT elevations had a median time to onset of 8 weeks, resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10 copies/ml reduction in viral load that preceded or coincided with the ALT elevation.
Danish: Disse stigninger forsvandt ved fortsat behandling og var i de fleste tilfælde associeret med en reduktion i virusmængden på ≥ 2 log10 kopier/ml, som gik forud for eller faldt sammen med ALAT-stigningen.
English: Flares after treatment discontinuation: Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
Danish: Opblussen efter seponering af behandlingen: Akut hepatitis-eksacerbation er også blevet rapporteret hos patienter efter seponering af hepatitis B-behandlingen.
English: One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant (> 4%) lumbar spine BMD loss at week 48.
Danish: Én patient behandlet med tenofovirdisoproxil og ingen patienter behandlet med stavudin eller zidovudin havde signifikant (> 4 %) BMD-tab i columna lumbalis ved uge 48.
English: Tenofovir disoproxil was associated with significantly greater proportions of patients with undetectable HBV DNA (< 169 copies/ml [< 29 IU/ml]; the limit of quantification of the Roche Cobas Taqman HBV assay), when compared to adefovir dipivoxil (study GS-US-174-0102; 91%, 56% and study GS-US-174-0103; 69%, 9%), respectively.
Danish: Tenofovirdisoproxil var forbundet med signifikant større andele af patienter med HBV-DNA, som ikke kunne måles (< 169 kopier/ml [< 29 IE/ml]; kvantificeringsgrænsen for Roche Cobas Taqman HBVassayet), sammenlignet med adefovirdipivoxil (studie GS-US-174-0102; 91 %, 56 % henholdsvis studie GS-US-174-0103; 69 %, 9 %).
English: If tenofovir disoproxil is co-administered with an NSAID, renal function should be monitored adequately.
Danish: Hvis tenofovirdisoproxil administreres sammen med et NSAID, skal nyrefunktionen monitoreres på tilstrækkelig vis.
English: If a patient misses a dose of Tenofovir disoproxil Zentiva within 12 hours of the time it is usually taken, the patient should take Tenofovir disoproxil Zentiva with food as soon as possible and resume their normal dosing schedule.
Danish: Hvis en patient glemmer at tage en dosis Tenofovir disoproxil Zentiva i mindre end 12 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Tenofovir disoproxil Zentiva sammen med mad så snart som muligt og derefter fortsætte med den normale doseringsplan.
English: Experience in patients with compensated liver disease at 48 weeks (studies GS-US-174-0102 and GS-US
Danish: Erfaring hos patienter med kompenseret leversygdom i uge 48 (studie GS-US-174-0102 og GS-US-174
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)
Danish: Metaboliske parametre Kropsvægt og niveauerne af lipid og glucose i blodet kan stige under antiretroviral behandling (se pkt.
English: - aminoglycosides, pentamidine or vancomycin (for bacterial infection) - amphotericin B (for fungal infection)
Danish: − aminoglykosider, pentamidin eller vancomycin (mod bakteriel infektion)
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV, non-HBV infected adult patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Danish: En enkelt dosis af 245 mg tenofovirdisoproxil blev administreret til voksne patienter uden hiv- eller HBV-infektion med forskellige grader af nedsat leverfunktion defineret i henhold til Child-PughTurcotte (CPT) klassifikationen.
English: Tenofovir disoproxil should be avoided in antiretroviral experienced patients with strains harbouring the K65R mutation (see section 4.4).
Danish: Tenofovirdisoproxil bør undgås hos tidligere antiretroviral-behandlede patienter med stammer, som har K65R-mutationen (se pkt.
English: Possible serious side effects: tell your doctor immediately Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 people) but serious side effect that can be fatal.
Danish: Laktatacidose (overskud af mælkesyre i blodet) er en sjælden (kan opstå hos op til 1 ud af 1.000 personer), men alvorlig bivirkning, som kan være dødelig.
English: In patients with end-stage renal disease (ESRD) (CrCl < 10 ml/min) requiring haemodialysis, between dialysis tenofovir concentrations substantially increased over 48 hours achieving a mean Cmax of 1,032 ng/ml and a mean AUC0-48h of 42,857 ng h/ml.
Danish: Hos patienter med nyresygdom i slutstadiet (End Stage Renal Disease, ESRD) (CrCl < 10 ml/min), som havde behov for hæmodialyse, steg tenofovirkoncentrationerne mellem dialyser betydeligt over 48 timer, hvilket gav en gennemsnitlig Cmax på 1.032 ng/ml og en gennemsnitlig AUC0-48t på 42.857 ng t/ml.
English: Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together.
Danish: Der er rapporteret om sjældne tilfælde af betændelse i bygspytkirtlen og laktatacidose (overskud af mælkesyre i blodet), der somme tider har medført dødsfald, når medicin, der indeholder tenofovirdisoproxil og didanosin, blev indtaget samtidigt.
English: The mean baseline CD4 cell count was 279 cells/mm3, the mean baseline plasma HIV-1 RNA was 4.91 log10 copies/ml, 19% of patients had symptomatic HIV-1 infection and 18% had AIDS.
Danish: Det gennemsnitlige CD4-celletal ved baseline var 279 celler/mm3, den gennemsnitlige hiv 1-RNA-plasmakoncentration ved baseline var 4,91 log10 kopier/ml, 19 % af patienterne havde symptomatisk hiv 1-infektion og 18 % havde aids.
English: Only 1 subject randomized to the TDF group was genotype E at baseline.
Danish: Der var kun 1 forsøgsperson, der var randomiseret til tenofovirdisoproxil-gruppen, der var genotype E ved baseline.
English: Hepatitis B infection Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with:
Danish: Hepatitis B-infektion Tenofovir disoproxil Zentiva er indiceret til behandling af kronisk hepatitis B hos voksne, der har:
English: Fifty-four patients (including 2 patients with lamivudine resistance mutations at baseline) initially received blinded placebo treatment for 72 weeks, and 52/54 patients followed with tenofovir disoproxil (PLB-tenofovir disoproxil group).
Danish: 54 patienter (herunder 2 patienter med lamivudinresistente mutationer ved baseline) fik indledningsvist blindet placebobehandling i 72 uger, og 52/54 patienter fik derefter tenofovirdisoproxil (PLBtenofovirdisoproxil-gruppen).
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: Sammenlignelige procentdele af patienterne i tenofovirdisoproxil-tenofovirdisoproxil- og PLBtenofovirdisoproxil-grupperne (henholdsvis 37,5 % og 41,7 %) oplevede serokonversion til anti-HBe til og med uge 192.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue.
Danish: Tenofovirdisoproxil absorberes og omdannes til det aktive stof tenofovir, som er en nukleosidmonophosphat (nukleotid)analog.
English: The effects of tenofovir disoproxil -associated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Danish: Virkningerne af ændringer i BMD associeret med tenofovirdisoproxil på knoglesundheden på længere sigt og fremtidig frakturrisiko kendes ikke på nuværende tidspunkt (se pkt.
English: You do not need to take another tablet if you were sick more than 1 hour after taking Tenofovir disoproxil Zentiva.
Danish: Du behøver ikke tage en ny tablet, hvis du kaster op mere end en time efter, at du tog Tenofovir disoproxil Zentiva-tabletten.
English: No significant effect on lopinavir/ritonavir PK parameters.
Danish: Ingen signifikant virkning på de farmakokinetiske parametre for lopinavir/ritonavir.
English: Tenofovir disoproxil should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during tenofovir disoproxil therapy.
Danish: Tenofovirdisoproxil bør ikke initieres til pædiatriske patienter med nedsat nyrefunktion, og bør seponeres hos pædiatriske patienter, som udvikler nedsat nyrefunktion i løbet af behandlingen med tenofovirdisoproxil.