FrancophonIA/ELRC3.0 huggingface dataset:
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: d The population used for analysis of ALT normalisation included only patients with ALT above ULN at baseline.
Danish: Populationen, som blev brugt til analyse af ALAT-normalisering, inkluderede kun patienter med ALAT over ULN ved baseline.
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: 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 tenofovirdisoproxilresistens (se Klinisk virkning og sikkerhed).
English: After 72 weeks of blinded randomized treatment, each subject could switch to open-label tenofovir disoproxil treatment up to week 192.
Danish: Efter 72 uger med blindet randomiseret behandling kunne hver patient skifte til open-label-behandling med tenofovirdisoproxil op til uge 192.
English: In exceptional circumstances in patients having particular difficulty in swallowing, Tenofovir disoproxil Zentiva can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice.
Danish: I særlige tilfælde, hos patienter der har problemer med at synke, kan Tenofovir disoproxil Zentiva administreres, efter tabletten er blevet knust og opløst i mindst 100 ml vand, appelsinjuice eller druesaft.
English: HIV-1 infection
Danish: Hiv 1-infektion
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: 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 point.
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 peak-plasmakoncentrationer og lavere Cmin niveauer hos patienter med nedsat nyrefunktion sammenlignet med patienter med normal nyrefunktion.
English: Co-infection with hepatitis C or D: There are no data on the efficacy of tenofovir in patients co-infected 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: Cumulatively, there were 4 patients who experienced a viremic episode (HBV DNA > 400 copies/ml) at their last time point on tenofovir disoproxil.
Danish: Kumulativt var der 4 patienter, som oplevede en viræmisk episode (HBV-DNA > 400 kopier/ml) på det sidste tidspunkt på tenofovirdisoproxil.
English: No dosing recommendations can be given for non-haemodialysis patients with creatinine clearance < 10 ml/min.
Danish: Der kan ikke gives nogle dosisanbefalinger til ikke-hæmodialyse-patienter med kreatininclearance < 10 ml/min.
English: Table 2: Tabulated summary of adverse reactions associated with tenofovir disoproxil based on clinical study and post-marketing experience
Danish: Tabel 2: Resumé af bivirkninger forbundet med tenofovirdisoproxil baseret på erfaringer fra kliniske studier og efter markedsføring
English: There are limited data on the safety and efficacy of tenofovir disoproxil in HBV infected patients with decompensated liver disease and who have a Child-Pugh-Turcotte (CPT) score > 9.
Danish: Der er begrænsede data om sikkerhed og virkning hos HBV-inficerede patienter med dekompenseret leversygdom, som har Child-Pugh-Turcotte (CPT) score > 9.
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 tenofovirdisoproxil fordeles tenofovir til de fleste væv, hvor de højeste koncentrationer forekommer i nyrer, lever og tarmindhold (prækliniske studier).
English: Tenofovir disoproxil Zentiva is available only as 245 mg film-coated tablets, it is not suitable for the use in paediatric patients aged 2 < 12 years.
Danish: Tenofovir disoproxil Zentiva fås kun som 245 mg filmovertrukne tabletter og er ikke egnet til brug hos pædiatriske patienter fra 2 til < 12 år.
English: Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Danish: Leverfunktionen bør monitoreres i regelmæssige intervaller, både med klinisk kontrol og laboratoriekontroller, i mindst 6 måneder efter seponering af hepatitis B-behandlingen.
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 tenofovirdisoproxil sammenlignet med placebo baseret på plasma-hiv 1-RNAniveauer ved uge 24.
English: The distribution of HBV genotypes at baseline was similar between the TDF and Placebo groups.
Danish: Fordelingen af HBV-genotyper ved baseline var sammenlignelig tenofovirdisoproxil- og placebogruppen imellem.
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: Approximately 1% of tenofovir disoproxil -treated adult patients discontinued treatment due to the gastrointestinal events.
Danish: Ca. 1 % af de tenofovirdisoproxil-behandlede voksne patienter ophørte med behandlingen på grund af gastrointestinale symptomer.
English: Tenofovir disoproxil must be taken with food, as food enhances the bioavailability of tenofovir (see section
Danish: Tenofovirdisoproxil skal tages sammen med mad, da mad forbedrer tenofovirs biotilgængelighed (se pkt.
English: Renal clearance has been estimated to be approximately 160 ml/h/kg (approximately 210 ml/min), which is in excess of the glomerular filtration rate.
Danish: Renal clearance er beregnet til at være ca. 160 ml/t/kg (ca. 210 ml/min), hvilket er over den glomerulære filtreringshastighed.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig for batchfrigivelse
English: Given that tacrolimus can affect renal function, close monitoring is recommended when it is co-administered with tenofovir disoproxil.
Danish: Da tacrolimus kan påvirke nyrefunktionen, anbefales tæt monitorering, når det administreres samtidigt med tenofovirdisoproxil.
English: The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus and the uncertainties as regards the long term impact of bone and renal toxicity (see section 4.4).
Danish: Fordelene ved langvarig virologisk suppression med fortsat behandling skal opvejes mod risikoen ved langvarig behandling, herunder udvikling af resistent hepatitis B-virus og usikkerhederne i forbindelse med virkningen på knogle- og nyretoksicitet ved langvarig behandling (se pkt.
English: n (%)a
Danish: n (%)
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Danish: Sent forekommende neurologiske forstyrrelser er i sjældne tilfælde blevet rapporteret (hypertoni, kramper, unormal adfærd).
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: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was coadministered 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 tenofovirdisoproxil blev administreret sammen med emtricitabin, lamivudin, indinavir, efavirenz, nelfinavir, saquinavir (ritonavirboostet), methadon, ribavirin, rifampicin, tacrolimus eller hormonantikonceptionsmidlet norgestimat/ethinylestradiol.
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: Tenofovir disoproxil Zentiva with food and drink Take Tenofovir disoproxil Zentiva with food (for example, a meal or a snack).
Danish: Brug af Tenofovir disoproxil Zentiva sammen med mad og drikke Tag Tenofovir disoproxil Zentiva sammen med mad (for eksempel et måltid eller et mellemmåltid).
English: If you think that you may have any of these serious side effects, talk to your doctor.
Danish: Hvis du tror, at du har nogle af disse alvorlige bivirkninger, skal du kontakte din læge.
English: Do not change the dose unless your doctor tells you to.
Danish: Du må ikke ændre din dosis, medmindre du har fået besked på det af din læge.
English: Haemodialysis patients: 245 mg tenofovir disoproxil may be administered every 7 days following completion of a haemodialysis session*.
Danish: Hæmodialyse-patienter: 245 mg tenofovirdisoproxil kan administreres hver 7. dag efter afslutning af en hæmodialyse-session*.
English: In studies GS-US-174-0102 and GS-US-174-0103, 77% and 61% of patients continued in the study through to 384 weeks, respectively.
Danish: I studierne GS-US-174-0102 og GSUS-174-0103 fortsatte henholdsvis 77 % og 61 % af patienterne i studiet til og med uge 384.
English: Confirmed increase in serum creatinine ≥ 0.5 mg/dl from baseline or confirmed serum phosphate of < 2 mg/dl n (%)b
Danish: Bekræftet forhøjelse af serumkreatinin ≥ 0,5 mg/dl fra baseline eller bekræftet serumphosphat på < 2 mg/dl n (%)
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 tenofovirdisoproxil kun anvendes som en del af en passende, antiretroviral kombinationsbehandling hos patienter med samtidig hiv/HBV-infektion.
English: If bone abnormalities are suspected or detected then appropriate consultation should be obtained.
Danish: Hvis der er mistanke om knogleabnormiteter, eller disse påvises, skal relevant konsultation foretages.
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-reverse-transkriptase og HBVpolymerase ved direkte bindingskonkurrence med det naturlige deoxyribonukleotidsubstrat og - efter indføjelse i DNA - ved DNA-kædeblokering.
English: hepatic steatosis, hepatitis Skin and subcutaneous tissue disorders: Very common:
Danish: steatosis hepatis, hepatitis Hud og subkutane væv: Meget almindelig: udslæt Sjælden:
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 tenofovirdisoproxil med adefovirdipivoxil hos voksne patienter med kompenseret leversygdom, vises i tabel 3 nedenfor.
English: The safety and efficacy of tenofovir disoproxil in HIV-1 infected children or children with chronic hepatitis B under 2 years of age have not been established.
Danish: Tenofovir disoproxils sikkerhed og virkning hos hiv 1-inficerede børn eller børn med kronisk hepatitis B under 2 år er ikke klarlagt.
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: 2 The predominant circulating metabolite of sofosbuvir.
Danish: Den primære cirkulerende sofosbuvirmetabolit.
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 tenofovirdisoproxil på fertilitet.
English: • HIV adolescent educational brochure • HBV adolescent educational brochure
Danish: • HBV unge uddannelsesbrochure
English: If you notice any of these symptoms tell your doctor.
Danish: Hvis du bemærker et eller flere af disse symptomer, skal du fortælle det til din læge.
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: 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 tenofovirdisoproxil i 24 uger.
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 tenofovirdisoproxil.
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: 90 (3 bottles of 30) film-coated tablets
Danish: 90 (3 tabletbeholdere med hver 30) filmovertrukne tabletter
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 tenofovirdisoproxil.
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 tenofovirdisoproxil.
English: Tenofovir disoproxil Zentiva has not been studied in patients over 65 years of age.
Danish: Tenofovir disoproxil Zentiva er ikke undersøgt hos patienter over 65 år.
English: • Talk to your doctor if you have a history of liver disease, including hepatitis.
Danish: • Tal med din læge, hvis du tidligere har haft en leversygdom, herunder gulsot (hepatitis).
English: Do not take Tenofovir disoproxil Zentiva together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Danish: Tag ikke Tenofovir disoproxil Zentiva sammen med medicin, der indeholder adefovirdipivoxil (medicin, der anvendes til at behandle kronisk hepatitis B).
English: Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Danish: Patienter med levercirrose kan have større risiko for hepatisk dekompensation efter hepatitis-eksacerbation og skal derfor monitoreres tæt under behandlingen.
English: Tenofovir disoproxil Zentiva is suitable for:
Danish: Tenofovir disoproxil Zentiva er egnet til:
English: Tenofovir disoproxil Zentiva may cause a reduction in BMD.
Danish: Tenofovir disoproxil Zentiva kan forårsage en reduktion i BMD.
English: • Not for HIV-1 infected children under 12 years of age.
Danish: • Ikke til hiv 1-inficerede børn under 12 år
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Danish: Serum-ALAT- og HBV-DNA-niveauer bør følges regelmæssigt efter seponering af behandlingen for at kunne påvise et eventuelt sent virologisk tilbagefald.
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 tenofovirdisoproxil 245 mg tabletter hos børn under 12 år eller børn med nedsat nyrefunktion.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant cap and induction heat sealing (with aluminium foil).
Danish: Højdensitets-polyethylen (HDPE)-tabletbeholder med et børnesikret polypropylenlåg og varmeinduceret forsegling (med aluminiumsfolie).
English: Intracellular pharmacokinetics
Danish: Intracellulær farmakokinetik
English: • If you are allergic to tenofovir, tenofovir disoproxil phosphate or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for tenofovir, tenofovirdisoproxilphosphat eller et af de øvrige indholdsstoffer i Tenofovir disoproxil Zentiva (angivet i punkt 6).
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 du tidligere har haft nyresygdomme, eller hvis undersøgelser har vist, at du har nyreproblemer.
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 seponere behandlingen med tenofovirdisoproxil hos voksne patienter med kreatininclearance på < 50 ml/min eller fald i serumphosphat til < 1,0 mg/dl (0,32 mmol/l).
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 tenofovirdisoproxil; de fleste af dem er lette.
English: The pharmacokinetics of tenofovir in non-haemodialysis patients with creatinine clearance < 10 ml/min and in patients with ESRD managed by peritoneal or other forms of dialysis have not been studied.
Danish: Tenofovirs farmakokinetik hos ikke-hæmodialyse-patienter med kreatininclearance < 10 ml/min og hos patienter med ESRD kontrolleret af peritonealdialyse eller andre former for dialyse er ikke blevet undersøgt.
English: • That use of Tenofovir disoproxil Zentiva should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Danish: • At brugen af Tenofovir disoproxil Zentiva bør undgås med samtidig eller nylig brug af nefrotoksiske lægemidler.
English: Lactose monohydrate Hypromellose
Danish: Lactosemonohydrat Hypromellose
English: Warnings and precautions Talk to your doctor or pharmacist before taking Tenofovir disoproxil Zentiva
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Tenofovir disoproxil Zentiva.
English: Moderate renal impairment (creatinine clearance 30 - 49 ml/min) If administration of a lower dose 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) Hvis det ikke er muligt at administrere en lavere dosis, kan 245 mg filmovertrukne tabletter anvendes med forlængede doseringsintervaller.
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: Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.
Danish: Tenofovir disoproxil Zentiva er også indiceret til behandling af hiv 1-inficerede unge med NRTIresistens eller toksiciteter, der udelukker brugen af førstevalgsbehandling, i alderen 12 til < 18 år.
English: The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Danish: Nedbrydning af muskelvæv, kalktab fra knoglerne (med knoglesmerter; kan nogle gange resultere i knoglebrud), muskelsmerter, muskelsvaghed og fald i blodets kalium- og phosphatniveau kan forekomme på grund af skader på celler i nyrerne (de tubulære celler).
English: Periodic monitoring of hepatic function is recommended during treatment (see section 4.4).
Danish: Der anbefales periodisk monitorering af leverfunktionen under behandling (se pkt 4.4).
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: 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 tenofovirdisoproxil i en eller flere undergrupper af den pædiatriske population med hiv og kronisk hepatitis B (se pkt.