natgillin/translations-raw huggingface dataset:
In patients who develop renal insufficiency and have advanced liver disease or cirrhosis, dosing interval adjustment of adefovir or switch to an alternative therapy for hepatitis B infection should be considered.
Pri bolnikih, ki razvijejo ledvično insuficienco in imajo napredovalo bolezen jeter ali cirozo, je treba razmisliti o prilagajanju intervalov med odmerki adefovirja ali menjavi k alternativni terapiji za hepatitis B.
Treatment cessation for chronic hepatitis B in these patients is not recommended.
Prenehanje zdravljenja kroničnega hepatitisa B pri teh bolnikih ni priporočljivo.
Patients with normal renal function:
Bolniki z normalno ledvično funkcijo:
Patients with normal renal function should be monitored for changes in serum creatinine every 3 months and creatinine clearance calculated.
Pri bolnikih z normalno ledvično funkcijo je treba nadzorovati spremembe vrednosti serumskega kreatinina in določiti očistek kreatinina vsake tri mesece.
In patients at risk of renal impairment (see section 4.8), consideration should be given to more frequent monitoring of renal function.
Pri bolnikih s tveganjem za motnje v delovanju ledvic (glejte poglavje 4. 8) je treba razmisliti o pogostejšem nadzorovanju ledvičnega delovanja.
The dosing interval of adefovir dipivoxil should be adjusted in these patients (see section 4.2).
Interval med odmerki je treba pri teh bolnikih prilagoditi (glejte poglavje 4. 2).
In addition, renal function should be closely monitored with a frequency tailored to the individual patient’ s medical condition.
Poleg tega je treba ledvično funkcijo skrbno nadzorovati in prilagoditi pogostnost nadzora zdravstvenemu stanju posameznega bolnika.
Adefovir dipivoxil is not recommended in patients with a creatinine clearance of < 30 ml/ min or on dialysis.
Pri bolnikih z očistkom kreatinina < 30 ml/ min ali bolnikih na dializi uporaba adefovirdipivoksila ni priporočena.
Administration of adefovir dipivoxil in these patients should only be considered if the potential benefits outweigh the potential risks.
Možnost uporabe adefovirdipivoksila pri teh bolnikih se lahko pretehta samo, če morebitne koristi odtehtajo morebitna tveganja.
If treatment with adefovir dipivoxil is considered essential, then the dosing interval should be adjusted (see section 4.2).
Če zdravnik oceni, da je zdravljenje z adefovirdipivoksilom nujno, je treba interval med odmerki prilagoditi (glejte poglavje 4. 2).
Adefovir dipivoxil should not be administered concurrently with tenofovir disoproxil fumarate (Viread).
Adefovirdipivoksil se ne sme jemati sočasno s tenofovirdizoproksil fumaratom (Viread).
Caution is advised in patients receiving other medicinal products that may affect renal function or are excreted renally (e. g. cyclosporin and tacrolimus, intravenous aminoglycosides, amphotericin B, foscarnet, pentamidine, vancomycin, or medicinal products which are secreted by the same renal transporter, human Organic Anion Transporter 1 (hOAT1), such as cidofovir).
Pri bolnikih, ki prejemajo druga zdravila, ki lahko vplivajo na ledvično funkcijo ali se izločajo preko ledvic (npr. ciklosporin in takrolimus, intravenski aminoglikozidi, amfotericin B, foskarnet, pentamidin, vankomicin in zdravila, ki se izločajo preko istega ledvičnega prenašalca (hOAT1, human Organic Anion Transporter 1) kot je cidofovir), je potrebna previdnost.
Co-administration of 10 mg adefovir dipivoxil with medicinal products in these patients may lead to an increase in serum concentrations of either adefovir or a co-administered medicinal product.
Sočasno jemanje 10 mg adefovirdipivoksila s temi zdravili lahko pri bolnikih privede do povišanja serumskih koncentracij bodisi adefovirja, bodisi sočasno vzetega zdravila.
The renal function of these patients should be closely monitored with a frequency tailored to the individual patient’ s medical condition.
Ledvično funkcijo se mora pri teh bolnikih skrbno nadzorovati in prilagoditi pogostnost nadzora zdravstvenemu stanju posameznega bolnika.
For renal safety in patients pre- and post-transplantation with lamivudine-resistant HBV, see section 4.8.
Za varnost za ledvice pri bolnikih pred in po transplantaciji, z na lamivudin odpornim HBV, glejte poglavje 4. 8.
Hepatic function:
Jetrna funkcija:
Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT.
Spontana poslabšanja kroničnega hepatitisa B so dokaj običajna in jih označujejo prehodna povišanja vrednosti serumske ALT.
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation (see section 4.8).
Pri bolnikih s kompenzirano boleznijo jeter povišanje vrednosti serumske ALT na splošno ne spremlja zvišanje koncentracij serumskega bilirubina ali jetrna dekompenzacija (glejte poglavje 4. 8).
In these patients, including patients with decompensated liver disease, treatment cessation is not recommended and these patients should be monitored closely during therapy.
Ti bolniki morajo biti med zdravljenjem skrbno nadzorovani.
If treatment cessation is necessary, patients should be closely monitored for several months after stopping treatment as exacerbations of hepatitis have occurred after discontinuation of 10 mg adefovir
4 Če je potrebno prenehanje zdravljenja, morajo biti bolniki še nekaj mesecev po ukinitvi zdravljenja skrbno nadzorovani, saj so se po prekinitvi uporabe 10 mg adefovirdipivoksila pojavila poslabšanja hepatitisa.
Elevations in serum ALT that occurred in patients with compensated liver function treated with 10 mg adefovir dipivoxil were not accompanied by clinical and laboratory changes associated with liver decompensation.
Dvigov vrednosti serumske ALT, ki so se pojavili pri bolnikih s kompenzirano jetrno funkcijo, zdravljenih z 10 mg adefovirdipivoksila, niso spremljale klinične in laboratorijske spremembe povezane z jetrno dekompenzacijo.
Most post-treatment exacerbations of hepatitis were seen within 12 weeks of discontinuation of 10 mg adefovir dipivoxil.
Večina poslabšanj hepatitisa, ki so nastopila po zdravljenju, so se pojavila v prvih 12 tednih po prekinitvi zdravljenja z 10 mg adefovirdipivoksila.
Lactic acidosis and severe hepatomegaly with steatosis:
Laktacidoza in resna oblika hepatomegalije z steatozo:
Occurrences of lactic acidosis (in the absence of hypoxaemia), sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
Ob uporabi analogov nukleozidov so poročali o pojavu laktacidoze (brez hipoksemije), ki je bila včasih smrtna in običajno združena z resno hepatomegalijo in jetrno steatozo.
Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/ lactic acidosis of unknown aetiology occur.
Zdravljenje z analogi nukleozidov se mora prekiniti, če se pojavi hitro naraščujoč nivo vrednosti aminotransferaze, napredujoča hepatomegalija ali metabolična acidoza/ laktacidoza neznane etiologije.
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/ hepatic steatosis, renal failure and higher levels of serum lactate.
Resni primeri, včasih s smrtnim izidom, so bili povezani s pankreatitisom, jetrno odpovedjo/ jetrno steatozo, ledvično odpovedjo in višjimi vrednostmi serumskega laktata.
Co-infection with hepatitis C or D:
Sočasna okužba z hepatitisom C ali D:
There are no data on the efficacy of adefovir dipivoxil in patients co-infected with hepatitis C or hepatitis D.
Ni podatkov o učinkovitosti adefovirdipivoksila pri bolnikih sočasno okuženih s hepatitisom C ali hepatitisom D.
Co-infection with HIV:
Sočasna okužba s HIV:
Limited data are available on the safety and efficacy of 10 mg adefovir dipivoxil in patients with chronic hepatitis B, co-infected with HIV.
Na voljo je omejeno število podatkov o varnosti in učinkovitosti 10 mg adefovirdipivoksila pri bolnikih s kroničnim hepatitisom B, ki so sočasno okuženi s HIV.
To date there is no evidence that daily dosing with 10 mg adefovir dipivoxil results in emergence of adefovir-associated resistance mutations in the HIV reverse transcriptase.
Za sedaj ni dokazov da bi dnevni odmerek 10 mg adefovirdipivoksila povzročil nastanek mutacije za rezistenco povezane z adefovirjem v HIV reverzni transkriptazi.
Nonetheless, there is a potential risk of selection of HIV strains resistant to adefovir with possible cross-resistance to other antiviral medicinal products.
Kljub temu pa obstaja potencialno tveganje, da se izbere HIV seve, ki so odporni proti adefovirju z možno navkrižno odpornostjo na druga protivirusna zdravila.
As far as possible, treatment of hepatitis B by adefovir dipivoxil in an HIV co-infected patient should be reserved for patients whose HIV RNA is controlled.
Kolikor je mogoče, naj bi bilo zdravljenje hepatitisa B z adefovirdipivoksilom pri bolnikih sočasno okuženih s HIV omejeno na bolnike s kontrolirano vrednostjo HIV RNA.
Treatment with 10 mg adefovir dipivoxil has not been shown to be effective against HIV replication and therefore should not be used to control HIV infection.
Zdravljenje s 10 mg adefovirdipivoksila se ni pokazalo kot učinkovito proti replikaciji HIV in se zato naj ne bi uporabljalo za nadzorovanje okužbe s HIV.
The clinical experience in patients > 65 years of age is very limited.
Klinične izkušnje zdravljenja bolnikov starejših od 65 let so zelo omejene.
Caution should be exercised when prescribing adefovir dipivoxil to the elderly, keeping in mind the greater frequency of decreased renal or cardiac function in these patients, and the increase in concomitant diseases or concomitant use of other medicinal products in the elderly.
Pri predpisovanju adefovirdipivoksil starejšim je potrebna previdnost, saj je treba upoštevati, da je pri teh bolnikih bolj pogosto slabše delovanje ledvic in srca, da imajo več obolenj sočasno oziroma sočasno jemljejo več zdravil.
Resistance to adefovir dipivoxil (see section 5.1) can result in viral load rebound which may result in exacerbation of hepatitis B and, in the setting of diminished hepatic function, lead to liver decompensation and possible fatal outcome.
Odpornost na adefovirdipivoksil (glejte poglavje 5. 1) lahko povzroči povratni odziv virusne obremenitve, kar lahko nadalje povzroči poslabšanje hepatitisa B, ob poslabšanem jetrnem delovanju pa tudi dekompenzijo jeter in morebitni smrtni izid.
Virological response should be closely monitored in patients treated with adefovir dipivoxil, with HBV DNA measured every 3 months.
Pri bolnikih, ki se zdravijo z adefovirdipivoksilom, je treba skrbno spremljati virološki odziv, pri čemer je treba vrednost HBV DNA meriti vsake tri mesece.
Patients should be advised that therapy with adefovir dipivoxil has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore appropriate precautions should still be taken.
Zato je potrebno nadaljevati s primernimi previdnostnimi ukrepi.
Hepsera contains lactose monohydrate.
5 Hepsera vsebuje laktozo monohidrat.
Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
A clinical study in liver-transplant patients has shown that no pharmacokinetic interaction occurs when adefovir dipivoxil 10 mg once daily is administered concomitantly with tacrolimus, an immunosuppressant which is predominantly metabolised via the CYP450 system.
Klinična študija pri bolnikih s transplantacijo jeter je pokazala, da ne pride do farmakokinetičnega medsebojnega delovanja pri sočasnem jemanju adefovirdipivoksila 10 mg enkrat na dan s takrolimusom, imunosupresivom, ki se pretežno presnavlja prek sistema CYP450.
Nevertheless, given that tacrolimus and cyclosporin can affect renal function, close monitoring is recommended when either of these agents is coadministered with adefovir dipivoxil (see section 4.4).
Ker lahko takrolimus in ciklosporin vplivata na ledvično funkcijo, je kljub temu priporočljiv skrben nadzor, če se katero od teh zdravil jemlje sočasno z adefovirdipivoksilom (glejte poglavje 4. 4).
Concomitant administration of 10 mg adefovir dipivoxil and 100 mg lamivudine did not alter the pharmacokinetic profile of either medicinal product.
Sočasno jemanje 10 mg adefovirdipivoksila in 100 mg lamivudina ni spremenilo njunih farmakokinetičnih lastnosti.
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product (see section 4.4).
Sočasno jemanje 10 mg adefovirdipivoksila z drugimi zdravili, ki se izločajo preko tubularne sekrecije ali spremenijo tubularno funkcijo, lahko povzroči zvišanje serumske koncentracije adefovirja oziroma sočasno vzetega zdravila (glejte poglavje 4. 4).
No data on the concomitant use with other medicinal products (including interferon) are available.
Podatkov o sočasni uporabi z drugimi zdravili (vključno z interferonom) ni na voljo.
There are no adequate data on the use of adefovir dipivoxil in pregnant women.
Ni zadostnih podatkov o uporabi adefovirdipivoksila pri nosečnicah.
Studies in animals administered adefovir intravenously have shown reproductive toxicity (see section 5.3).
Študije na živalih, ki so jim adefovir dajali intravenozno, so pokazale toksičen vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
Adefovir dipivoxil should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Adefovirdipivoksil se sme uporabljati v nosečnosti samo v primeru, kadar pričakovana korist upravičuje potencialno tveganje za plod.
There are no data on the effect of adefovir dipivoxil on transmission of HBV from mother to infant.
Ni podatkov o tem kako adefovirdipivoksil vpliva na prenos HBV z matere na otroka.
Given that the potential risks to developing human foetuses are unknown, it is recommended that women of child-bearing potential treated with adefovir dipivoxil use effective contraception.
Za ženske v rodni dobi, ki se zdravijo z adefovirdipivoksilom, je priporočljivo da uporabljajo učinkovito kontracepcijo, ker potencialno tveganje za razvoj človeškega plodu ni znano.
It is not known whether adefovir is excreted in human milk.
Ni znano ali adefovir prehaja v človeško mleko.
Mothers should be instructed not to breast-feed if they are taking adefovir dipivoxil tablets.
Matere je potrebno poučiti naj ne dojijo med jemanjem tablet adefovirdipivoksila.
However, based on the safety profile and mechanism of action, adefovir dipivoxil is expected to have no or negligible influence on these abilities.
Vendar se na podlagi varnostnega profila in mehanizmov delovanja pričakuje, da adefovirdipivoksil nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
In patients with compensated liver disease, the most frequently reported adverse reactions during 48 weeks of adefovir dipivoxil therapy were asthenia (13%), headache (9%), abdominal pain (9%) and nausea (5%).
Neželeni učinki, o katerih so najpogosteje poročali pri bolnikih s kompenzirano boleznijo jeter med 48- tedenskim jemanjem adefovirdipivoksila, so bili astenija (13%), glavobol (9%), abdominalna bolečina (9%) in navzea (5%).
6 Assessment of adverse reactions is based on experience from post-marketing surveillance and from three pivotal clinical studies in patients with chronic hepatitis B:
Ocenjevanje neželenih učinkov temelji na izkušnjah po pridobitvi dovoljenja za promet in trženju zdravila in na treh osrednjih kliničnih študijah pri bolnikih s kroničnim hepatitisom B:
• two placebo-controlled studies in which 522 patients with chronic hepatitis B and compensated liver disease received double-blind treatment with 10 mg adefovir dipivoxil (n=294) or placebo (n=228) for 48 weeks. • an open-label study in which pre- (n=226) and post-liver transplantation patients (n=241) with lamivudine-resistant HBV were treated with 10 mg adefovir dipivoxil once daily, for up to 203 weeks (median 51 and 99 weeks, respectively).
99 tednov).
The adverse reactions considered at least possibly related to treatment are listed below, by body system organ class, and frequency.
Neželeni učinki za katere se smatra, da so bili vsaj možno povezani z zdravljenjem, so navedeni spodaj po organskih sistemih in pogostnosti.
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10) or not known (identified through post-marketing safety surveillance and the frequency cannot be estimated from the available data).
Pogostnost je definirana kot zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10) ali pogostnost ni znana (neželeni učinki opaženi pri spremljanju varnosti po pridobitvi dovoljenja za promet in trženju zdravila in njihove pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Common (≥ 1/ 100, < 1/ 10): headache.
Pogosto (≥ 1/ 100, < 1/ 10): glavobol.
Common (≥ 1/ 100, < 1/ 10): diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, flatulence.
Pogosto (≥ 1/ 100, < 1/ 10): diareja, bruhanje, abdominalna bolečina, dispepsija, navzea, flatulenca.
Frequency not known: pancreatitis.
Pogostnost ni znana: pankreatitis.
Common (≥ 1/ 100, < 1/ 10): rash, pruritus.
Pogosto (≥ 1/ 100, < 1/ 10): izpuščaj, srbečica.
Frequency not known: myopathy, osteomalacia (both associated with proximal renal tubulopathy).
Pogostnost ni znana: miopatija, osteomalacija (obe povezani s proksimalno ledvično tubulopatijo).
Very common (≥ 1/ 10): increases in creatinine.
Zelo pogosto (≥ 1/ 10): povišanje kreatinina.
Common (≥ 1/ 100, < 1/ 10): renal failure, abnormal renal function, hypophosphatemia.
Pogosto (≥ 1/ 100, < 1/ 10): ledvična odpoved, nenormalna ledvična funkcija, hipofosfatemija.
Frequency not known:
Pogostnost ni znana:
Fanconi syndrome, proximal renal tubulopathy.
Fanconijev sindrom, proksimalna ledvična tubulopatija.
Very common (≥ 1/ 10): asthenia.
Zelo pogosto (≥ 1/ 10): astenija.
Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with 10 mg adefovir dipivoxil (see section 4.4).
Klinični in laboratorijski dokazi poslabšanja hepatitisa so se pojavili po prekinitvi zdravljenja z 10 mg adefovirdipivoksila (glejte poglavje 4. 4).
However, mild to moderate increases in serum creatinine concentrations, hypophosphatemia and a decrease in carnitine concentrations were reported in 3%, 4% and 6% of patients, respectively, on extended treatment.
Vendar pa so poročali o blagih do zmernih zvišanjih koncentracij serumskega kreatinina pri 3% bolnikov, o hipofosfatemiji pri 4% bolnikov in o znižanju koncentracij karnitina pri 6% bolnikov pri podaljšanem zdravljenju.
In a long-term safety study of 65 HBeAg positive patients with compensated liver disease (after a median exposure of 234 weeks), 6 patients (9%) had confirmed increases in serum creatinine of at least 0.5 mg/ dl from baseline with 2 patients discontinuing from the study due to the elevated serum creatinine concentration.
V dolgoročni študiji varnosti s 65 HBeAg pozitivnimi bolniki s kompenzirano boleznijo jeter (po mediani izpostavljenosti 234 tednov) je bilo pri 6 bolnikih (9%) potrjeno povečanje serumskega kreatinina za vsaj 0, 5 mg/ dl od začetne vrednosti, dva bolnika pa sta prekinila študijo zaradi povečane
Patients with a confirmed increase in creatinine of ≥ 0.3 mg/ dl by week 48 were at a statistically significant higher risk of a subsequent confirmed increase in creatinine of ≥ 0.5 mg/ dl.
Bolniki s potrjenim povečanjem kreatinina za ≥ 0, 3 mg/ dl do 48. tedna so bili izpostavljeni statistično pomembnemu večjemu tveganju za pozneje potrjeno povečanje kreatinina za ≥ 0, 5 mg/ dl.
Hypophosphatemia and a decrease in carnitine concentrations were reported each in 3% of patients on extended treatment.
Pri 3% bolnikov na podaljšanem zdravljenju so poročali o hipofosfatemiji in zmanjšanju koncentracije karnitina.
7 Safety in patients with decompensated disease:
Varnost pri bolnikih z dekompenzirano boleznijo jeter:
In patients with decompensated liver disease, the most frequently reported adverse reactions during up to 203 weeks of adefovir dipivoxil therapy were increased creatinine (7%) and asthenia (5%).
Neželena učinka, o katerima so najpogosteje poročali pri bolnikih s dekompenzirano boleznijo jeter v do 203 tednih zdravljenja z adefovirdipivoksilom, sta bila povečana koncentracija kreatinina (7%) in astenija (5%).
Renal toxicity is an important feature of the safety profile of adefovir dipivoxil in patients with decompensated liver disease.
Toksičnost za ledvice je pomembna lastnost varnostnega profila adefovirdipivoksila pri bolnikih z dekompenzirano boleznijo jeter.
In clinical studies of wait-listed and post-liver transplantation patients, four percent (19/ 467) of patients discontinued treatment with adefovir dipivoxil due to renal adverse events.
V kliničnih študijah z bolniki na čakalni listi in bolnikih po transplantaciji jeter je 4% (19/ 467) bolnikov prekinilo zdravljenje z adefovirdipivoksilom zaradi neželenih učinkov na ledvicah.
Administration of 500 mg adefovir dipivoxil daily for 2 weeks and 250 mg daily for 12 weeks has been associated with the gastrointestinal disorders listed above and anorexia.
Jemanje 500 mg adefovirdipivoksila na dan 2 tedna in 250 mg na dan 12 tednov so spremljale zgoraj navedene bolezni prebavil in anoreksija.
Adefovir can be removed by haemodialysis; the median haemodialysis clearance of adefovir is 104 ml/ min.
Adefovir se lahko odstrani s hemodializo; vrednost mediane hemodializnega očistka za adefovir je 104 ml/ min.
Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code:
Farmakoterapevtska skupina: zaviralci nukleozidne in nukleotidne reverzne transkriptaze, oznaka ATC:
Adefovir dipivoxil is an oral prodrug of adefovir, an acyclic nucleotide phosphonate analogue of adenosine monophosphate, which is actively transported into mammalian cells where it is converted by host enzymes to adefovir diphosphate.
Adefovirdipivoksil je peroralno predzdravilo adefovirja, ki je acikličen nukleotid- fosfonatni analog adenozin monofosfata, ki se aktivno prenaša v celice sesalcev, kjer ga encimi gostitelja pretvorijo v adefovir difosfat.
Adefovir diphosphate selectively inhibits HBV DNA polymerases at concentrations 12-, 700-, and 10-fold lower than those needed to inhibit human DNA polymerases α, β, and γ, respectively.
Adefovir difosfat selektivno zavira HBV DNA- polimeraze pri koncentracijah, ki so 12, 700, in 10 krat nižje, kot so potrebne za zaviranje človeških DNA- polimeraz α, β in γ.
Adefovir is active against hepadnaviruses in vitro, including all common forms of lamivudine-resistant HBV (rtL180M, rtM204I, rtM204V, rtL180M/ rtM204V), famciclovir-associated mutations (rtV173L, rtP177L, rtL180M, rtT184S or rtV207I) and hepatitis B immunoglobulin escape mutations (rtT128N and rtW153Q), and in in vivo animal models of hepadnavirus replication.
Adefovir in vitro deluje proti hepadnavirusom, vključujoč vse običajne oblike na lamivudin odpornih HBV (rtL180M, rtM204I, rtM204V, rtL180M/ rtM204V), HBV z mutacijami povezanimi s famciklovirom (rtV173L, rtP177L, rtL180M, rtT184S ali rtV207I) in HBV z hepatitis B imunoglobulinu pobeglimi mutacijami (escape mutations) (rtT128N in rtW153Q) in v in vivo proti živalski obliki replikacije hepadnavirusa.
The demonstration of the benefit of adefovir dipivoxil is based on histological, virological, biochemical, and serological responses in adults with:
Dokaz koristnostni adefovirdipivoksila sloni na histoloških, viroloških, biokemičnih in seroloških odgovorih pri odraslih s:
In the majority of these studies adefovir dipivoxil 10 mg was added to ongoing lamivudine treatment in patients failing lamivudine therapy.
V večini teh raziskav je bilo 10 mg adefovirdipivoksila dodano k tekočemu zdravljenju z lamivudinom, bolnikom, pri katerih je bilo zdravljenje z lamivudinom neuspešno.