natgillin/translations-raw huggingface dataset:
Vurdering af resistens hos børn og unge er baseret på data fra nukleosid-naive pædiatriske patienter med HBeAg-positiv kronisk HBV-infektion i to igangværende kliniske forsøg (028 og 189).
The paediatric resistance assessment is based on data from nucleoside-treatment-naive paediatric patients with HBeAg-positive chronic HBV infection in two ongoing clinical trials (028 and 189).
Denne substitution blev kun fundet ved tilstedeværelsen af lamivudin-resistensassocierede substitutioner rtL180M plus rtM204V.
This substitution was detected only in the presence of lamivudine resistance-associated substitutions rtL180M plus rtM204V.
Amning: Det vides ikke, om entecavir udskilles i modermælk.
Breast-feeding: it is unknown whether entecavir is excreted in human milk.
Resultater fra leverbiopsi: 57 patienter fra pivotale nukleosid-naive studier 022 (HBeAg-positive) og 027 (HBeAg-negative), som deltog i et længerevarende rollover-forsøg, blev undersøgt for længerevarende påvirkning af leverhistologi.
Liver biopsy results: 57 patients from the pivotal nucleoside-naive studies 022 (HBeAg positive) and 027 (HBeAg negative) who enrolled in a long-term rollover study were evaluated for long-term liver histology outcomes.
Entecavir Accord må ikke anvendes under graviditet undtagen, hvis lægen har ordineret det til dig.
Entecavir Accord must not be used during pregnancy unless specifically directed by your doctor.
EXP Efter åbning af beholder skal indholdet anvendes inden for 90 dage.
EXP After opening the bottle use within 90 days.
Farmakokinetikken hos pædiatriske patienter med nedsat nyre- eller leverfunktion er ikke undersøgt.
Pharmacokinetics in paediatric patients with renal or hepatic impairment have not been studied.
**på hæmodialysedage administreres entecavir efter hæmodialysen.
** on haemodialysis days, administer entecavir after haemodialysis.
Nyreinsufficiens: Justering af dosis anbefales til patienter med nyreinsufficiens (se pkt.
Renal impairment: dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Svære tilfælde, i visse tilfælde med dødelig udgang, har været forbundet med pankreatitis, leversvigt/leversteatosis, nyresvigt og forhøjede niveauer af serum-lactat.
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/hepatic steatosis, renal failure and higher levels of serum lactate.
Reduktioner i hiv-RNA er blevet rapporteret hos hiv/HBV-inficerede patienter, der modtog entecavir-monoterapi uden HAART.
Reductions in HIV RNA have been reported in HIV/HBV co-infected patients receiving entecavir monotherapy without HAART.
Blandt andet medregnes årsager som død, manglende virkning, bivirkning, noncompliance/manglende opfølgning som svigt (f.eks. HBV-DNA ≥ 300 kopier/ml) c NC=M (noncompleters=svigt) dDefineres som nedgang eller ingen ændring fra baseline i CTP-tal.
b NC=F (noncompleter=failure), meaning treatment discontinuations before the analysis week, including reasons such as death, lack of efficacy, adverse event, noncompliance/loss-to-follow-up, are counted as failures (e.g., HBV DNA ≥ 300 copies/ml) c NC=M (noncompleters=missing) dDefined as decrease or no change from baseline in CTP score.
selvom du tager Entecavir Accord, kan du stadig smitte andre med hepatitis-B virus
taking Entecavir Accord will not stop you from infecting other people with hepatitis B
Hvis det næsten er tid til næste dosis, skal du ikke tage den glemte dosis, men vente og tage næste dosis til sædvanlig tid.
If it is almost time for your next dose, do not take the missed dose.
Calciumcarbonat Stivelse, prægelatiniseret Carmellosenatrium Sojapolysakkarider Citronsyremonohydrat Natriumstearylfumarat
Calcium carbonate Starch, Pregelatinized Carmellose sodium Soy polysaccharides Citric acid monohydrate Sodium stearyl fumarate
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE TEKST PÅ BEHOLDERENS ETIKET
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL TEXT
Hos patienter med suboptimal virologisk repons efter 24 ugers behandling med entecavir bør justering af behandlingen overvejes (se pkt.
In patients with a suboptimal virological response after 24 weeks of treatment with entecavir, a modification of treatment should be considered (see sections 4.5 and 5.1).
Tabellen viser entecavirs farmakokinetik efter enkelt 1 mg dosis (til patienter uden kronisk hepatitis B-infektion):
The pharmacokinetics of entecavir following a single 1 mg dose in patients (without chronic hepatitis B infection) are shown in the table below:
Blandt entecavir-behandlede patienter var den gennemsnitlige tid til ALAT-stigninger under behandling 4 - 5 uger.
Among entecavir-treated patients on-treatment exacerbations had a median time of onset of 4-5 weeks.
Klinisk resistens hos voksne: Patienter i kliniske forsøg, der initialt blev behandlet med entecavir 0,5 mg (ikke tidligere behandlet med nukleosid) eller 1,0 mg (lamivudin-refraktære), og hvor PCR HBV-DNA er målt under behandling ved eller efter Uge 24, er monitorerede for resistens.
Clinical resistance in Adults: patients in clinical trials initially treated with entecavir 0.5 mg (nucleoside-naive) or 1.0 mg (lamivudine-refractory) and with an on-therapy PCR HBV DNA measurement at or after Week 24 were monitored for resistance.
Patienter med inkompenseret leversygdom: I studie 048 fik 191 patienter med HBeAg-positiv eller HBeAg-negativ kronisk HBV-infektion og tegn på hepatisk inkompensation, defineret som et CTP-tal på 7 eller højere, 1 mg entecavir en gang dagligt eller 10 mg adefovirdipivoxil en gang dagligt.
Patients with decompensated liver disease: in study 048, 191 patients with HBeAg positive or negative chronic HBV infection and evidence of hepatic decompensation, defined as a CTP score of 7 or higher, received entecavir 1 mg once daily or adefovir dipivoxil 10 mg once daily.
Ingen tidligere nukleosid-behandling HBeAg-positiv (studie 022)
Nucleoside Naive HBeAg Positive (study 022)
Blandt entecavir-behandlede nukleosid-naive patienter var den gennemsnitlige tid til ALAT-stigning 23 - 24 uger, og 86% (24/28) af ALAT-stigningerne opstod hos HBeAg-negative patienter.
Among entecavir-treated nucleoside-naive patients, ALT elevations had a median time to onset of 2324 weeks, and 86% (24/28) of ALT elevations occurred in HBeAg negative patients.
Pædiatrisk population: Der blev observeret en lavere virologisk responsrate (HBV-DNA < 50 IE/ml) hos pædiatriske patienter med HBV-DNA ≥ 8.0 log10 IE/ml ved baseline (se pkt.
Paediatric population: A lower rate of virologic response (HBV DNA < 50 IU/ml) was observed in paediatric patients with baseline HBV DNA ≥ 8.0 log10 IU/ml (see section 5.1).
Tabletkerne: Calciumcarbonat, prægelatiniseret stivelse, carmellosenatrium, sojapolysakkarider, citronsyremonohydrat, natriumstearylfumarat.
Tablet core: Calcium carbonate, starch, pregelatinized, carmellose sodium, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.
Fremkomsten af hiv-resistens er set, når entecavir blev anvendt til behandling af kronisk hepatitis B-infektion hos patienter med hiv-infektion, som ikke fik antiretroviral kombinationsbehandling (highly active antiretroviral therapy - HAART) (se pkt.
Emergence of HIV resistance has been observed when entecavir was used to treat chronic hepatitis B infection in patients with HIV infection not receiving highly active antiretroviral therapy (HAART) (see section 5.1).
Kreatinin-clearance (ml/min)
Creatinine clearance (ml/min)
ikke almindelige (forekommer hos mellem 1 og 10 ud af 1.000 patienter): udslæt, hårtab.
uncommon (at least 1 in 1,000 patients): rash, hair loss.
Kompenseret leversygdom
Compensated liver disease
Indlemmelse af yderligere ETVr-aminosyreforandringer rtT184, rtS202 eller rtM250 medfører fald i entecavirfølsomhed i cellekulturer.
Incorporation of additional ETVr amino acid changes rtT184, rtS202 or rtM250 decreases entecavir susceptibility in cell culture.
Hos patienter med inkompenseret leversygdom eller cirrose frarådes seponering af behandlingen.
In patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.
Lamivudin-resistente stammer indeholdende rtL180M plus rtM204V i kombination med aminosyresubstitution rtA181C førte til 16 til 122 gange reduktion i entecavir fænotypisk følsomhed.
Lamivudine-resistant strains harboring rtL180M plus rtM204V in combination with amino acid substitution rtA181C conferred 16- to 122-fold reductions in entecavir phenotypic susceptibility.
Titandioxid (E171)
Titanium dioxide (E171) Macrogol
Sådan skal du tage Entecavir Accord Dosis af Entecavir Accord er ikke den samme til alle patienter.
How to take Entecavir Accord Not all patients need to take the same dose of Entecavir Accord.
Entecavir-eksponeringen hos lamivudin-erfarne forsøgspersoner, der fik entecavirdoser på 0,030 mg/kg og op til en maksimal dosis på 1,0 mg en gang dagligt var den samme som eksponeringen hos voksne, der fik en dosis på 1,0 mg en gang dagligt.
Entecavir exposure among lamivudine-experienced subjects receiving once daily doses of entecavir 0.030 mg/kg up to a maximum dose of 1.0 mg was similar to the exposure achieved in adults receiving once daily doses of 1.0 mg.
Entecavir Accord er kun tilgængelig som 0,5 og 1 mg filmovertrukne tabletter.
Entecavir Accord is only available as 0.5 and 1 mg film-coated tablets.
Cmax, AUC (0-24) og Cmin for disse forsøgspersoner var henholdsvis 14,48 ng/ml, 38,58 ng∙h/ml og 0,47 ng/ml.
The Cmax, AUC(0-24), and Cmin for these subjects was 14.48 ng/ml, 38.58 ng∙h/ml, and 0.47 ng/ml, respectively.
Resistens i cellekulturer: I forhold til vild-type HBV, viste LVDr vira indeholdende rtM204V- og rtL180M-substitutioner inden for den reverse transkriptase 8 gange mindre følsomhed over for entecavir.
Resistance in cell culture: relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Patienterne var enten ikke blevet behandlet for HBV tidligere, eller også var de tidligere behandlet (eksklusive tidligere behandling med entecavir, adefovirdipivoxil eller tenofovirdisoproxilfumarat).
Patients were either HBV-treatment-naïve or pretreated (excluding pretreatment with entecavir, adefovir dipivoxil, or tenofovir disoproxil fumarate).
En analyse af den inhibitoriske aktivitet af entecavir mod adskillige laboratoriemæssige og kliniske hiv-1-isolater, der anvender forskellige celler og analysebetingelser, resulterede i EC50-værdier fra 0,026 til > 10 µM.
An analysis of the inhibitory activity of entecavir against a panel of laboratory and clinical HIV-1 isolates using a variety of cells and assay conditions yielded EC50 values ranging from 0.026 to > 10 µM; the lower EC50 values were observed when decreased levels of virus were used in the assay.
De tilgængelige toksikologiske data fra dyr har vist, at entecavir udskilles i mælk (se pkt.
Available toxicological data in animals have shown excretion of entecavir in milk (for details see section 5.3).
Erfaring hos lamivudin-refraktære patienter med kompenseret leversygdom: I et randomiseret, dobbeltblindt forsøg med HBeAg-positive, lamivudin-refraktære patienter (026), hvor 85% af patienterne havde LVDr- mutationer ved baseline, skiftede patienter, der fik lamivudin ved inklusion, til entecavir 1 mg én gang dagligt uden udvaskning eller overlap (n = 141), eller patienterne fortsatte med lamivudin 100 mg, én gang dagligt (n = 145).
Experience in lamivudine-refractory patients with compensated liver disease: In a randomised, double-blind study in HBeAg positive lamivudine-refractory patients (026), with 85% of patients presenting LVDr mutations at baseline, patients receiving lamivudine at study entry either switched to entecavir 1 mg once daily, with neither a washout nor an overlap period (n = 141), or continued on lamivudine 100 mg once daily (n = 145).
I studier med nukleosid-naive patienter oplevede 6% af de entecavir-behandlede patienter og 10% af de lamivudin-behandlede patienter ALAT-stigninger (> 10 gange ULN og > 2 gange referenceværdien [mindst af baseline eller sidste måling ved afslutning af behandling]) ved opfølgning efter behandling.
In studies in nucleoside-naive patients, 6% of entecavir-treated patients and 10% of lamivudine-treated patients experienced ALT elevations (> 10 times ULN and > 2 times reference [minimum of baseline or last end-of-dosing measurement]) during post-treatment follow-up.
Entecavir Accord 1mg mg
Entecavir Accord 1 mg
Fortæl det til lægen, hvis du ammer.
Tell your doctor if you are breastfeeding.
Entecavir-eksponeringen hos nukleosid-naive forsøgspersoner, som fik entecavirdoser på 0,015 mg/kg og op til en maksimal dosis på 0,5 mg en gang dagligt var sammenlignelig med eksponeringen hos voksne, der fik en dosis på 0,5 mg en gang dagligt.
Entecavir exposure among nucleoside naïve subjects receiving once daily doses of entecavir 0.015 mg/kg up to a maximum dose of 0.5 mg was similar to the exposure achieved in adults receiving once daily doses of 0.5 mg.
Lamivudin-refraktære patienter eller patienter med inkompenseret leversygdom
Lamivudine-refractory or decompensated liver disease
Responset opretholdtes hos 75% (83/111) af entecavir-respondere vs. 73% (68/93) af lamivudin-respondere i studie 022 og hos 46% (131/286) af entecavir-respondere vs. 31% (79/253) af lamivudin-respondere i studie 027.
For patients who met protocol-defined response criteria, response was sustained throughout the 24week post-treatment follow-up in 75% (83/111) of entecavir responders vs 73% (68/93) for lamivudine responders in study 022 and 46% (131/286) of entecavir responders vs 31% (79/253) for lamivudine responders in study 027.
Ligeledes havde lamivudin-refraktære patienter, som opnåede HBVDNA < 104 log10 kopier/ml ved PCR i Uge 24, en lavere forekomst af resistens end de patienter, der ikke opnåede denne HBV-DNA (kumulativ sandsynlighed over 5 år på henholdsvis 17,6% [n=50] versus 60,5% [n=135]).
copies/ml by PCR at Week 24 had a lower rate of resistance than those who did not (5-year cumulative probability 17.6% [n= 50] versus 60.5% [n= 135], respectively).
Nyreinsufficiens: Clearance af entecavir falder med faldende kreatinin-clearance (se pkt.
Renal impairment: the clearance of entecavir decreases with decreasing creatinine clearance (see section 5.2).
Til børn og unge (fra 2-18 år) fås Entecavir Accord som 0,5 mg tabletter eller som oral entecaviropløsning.
For children and adolescents (from 2 to less than 18 years of age), Entecavir Accord 0.5 mg tablets are available or an entecavir oral solution may be available.
Benigne fordøjelsessymptomer, fx kvalme, opkastning og mavesmerter, kan være tegn på udvikling af laktacidose.
Benign digestive symptoms, such as nausea, vomiting and abdominal pain, might be indicative of lactic acidosis development.
Bortset fra lamivudin, adefovirdipivoxil- og tenofovirdisoproxilfumarat er effekten ved samtidig administration af entecavir og præparater, der udskilles gennem nyrerne eller påvirker nyrefunktionen, ikke evalueret.
Apart from lamivudine, adefovir dipivoxil and tenofovir disoproxil fumarate, the effects of coadministration of entecavir with medicinal products that are excreted renally or affect renal function have not been evaluated.
Tabellen viser resultater efter 48 uger fra randomiserede, dobbeltblinde forsøg, der sammenligner entecavir (ETV) med lamivudin (LVD) hos HBeAg-positive (022) og HBeAg-negative (027) patienter.
Results at 48 weeks of randomised, double blind studies comparing entecavir (ETV) to lamivudine (LVD) in HBeAg positive (022) and HBeAg negative (027) patients are presented in the table.
Hver 1 mg tablet indeholder 52 mg sojapolysakkarider.
Each 1 mg film-coated tablet contains 52 mg soy polysaccharides.
Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP. That expiry date refers to the last day of that month.
Sojapolysakkarider: Dette lægemiddel indeholder sojapolysakkarider.
Soy polysaccharides: This medicinal product contains soy polysaccharides.
(ng·t /ml) (CV)
(ng·h /ml) (CV)
Tabellen viser resultater efter 48 uger.
Results at 48 weeks are presented in the table.
30 x 1 filmovertrukket tablet; 3 blisterkort med 10 x 1 filmovertrukket tablet, hver i alu/aluperforeret enkeltdosisblister eller
30 x 1 film-coated tablet; 3 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters, or
År 4a
Year 4 a
hiv/HBV-inficerede patienter, som samtidig får antiretroviral behandling: Entecavir er blevet undersøgt hos 68 voksne med hiv/HBV-infektion, der modtog HAART-regimen, der indeholdt lamivudin (se pkt.
HIV/HBV co-infected patients receiving concomitant antiretroviral therapy: entecavir has been studied in 68 adults with HIV/HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
Kvalme, opkastning og mavesmerter kan være tegn på udvikling af lactacidose.
Symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis.
Øget forekomst af andre tumorer, inklusiv hjernegliomer hos han- og hunrotter, levercarcinomer hos hanmus, benigne vaskulæretumorer hos hunmus samt leveradenomer og carcinomer hos hunrotter sås udelukkende ved høje livstidsdoser.
Increased incidences of other tumours including brain gliomas in male and female rats, liver carcinomas in male mice, benign vascular tumours in female mice, and liver adenomas and carcinomas in female rats were seen only at high lifetime exposures.
30 x 1 filmovertrukket tablet 90 x 1 filmovertrukket tablet
30 x 1 film-coated tablets 90 x 1 film-coated tablets
Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Hvis du har spørgsmål, kan du kontakte lægen.
If you have any concerns consult your doctor.
Indlægsseddel: Information til brugeren Entecavir Accord 0,5 mg filmovertrukne tabletter Entecavir Accord 1 mg filmovertrukne tabletter entecavir
Package leaflet: Information for the user Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets entecavir
Erfaring med patienter med samtidig hiv-infektion: I en mindre gruppe patienter med hiv/HBVinfektion i HAART-regimer (highly active antiretroviral therapy) der omfattede lamivudin, svarede entecavirs sikkerhedsprofil til den hos monoinficerede HBV-patienter (se pkt.
Experience in patients co-infected with HIV: the safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudine-containing HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
Cmax, AUC (0-24) og Cmin for disse forsøgspersoner var henholdsvis 6,32 ng/ml, 18,33 ng∙h/ml og 0,28 ng/ml.
The Cmax, AUC(024), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.
Eksacerbationer efter seponering af behandling: Der er indberettet akutte eksacerbationer af hepatitis hos patienter, som har seponeret behandling af hepatitis B, inklusive behandling med entecavir (se pkt.
Exacerbations after discontinuation of treatment: acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B virus therapy, including therapy with entecavir (see section 4.4).
For 26 entecavir-behandlede og 28 lamivudin-behandlede patienter som fortsatte behandling ud over de 52 uger (i gennemsnit 96 uger), havde 96% af de entecavir-behandlede og 64% af de lamivudinbehandlede patienter HBV-DNA < 300 kopier/ml ved PCR ved behandlingens afslutning.
For 26 entecavir-treated and 28 lamivudine-treated patients who continued treatment beyond 52 weeks (median 96 weeks), 96% of entecavir-treated and 64% of lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR at end of dosing.
90 x 1 filmovertrukket tablet; 9 blisterkort med 10 x 1 filmovertrukket tablet, hver i alu/aluperforeret enkeltdosisblister.
90 x 1 film-coated tablet; 9 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters.
Efter åbning af beholder skal indholdet anvendes inden for 90 dage.
After opening the bottle use within 90 days.
Filmovertrukket tablet 30 filmovertrukne tabletter
Film-coated tablet 30 film-coated tablets
Du må ikke amme, mens du er i behandling med Entecavir Accord.
You should not breast-feed during treatment with Entecavir Accord.
Entecavir Accord-dosis٭
Entecavir Accord dosage*
Leverinsufficiens: dosisjustering er ikke nødvendig hos patienter med leverinsufficiens.
Hepatic impairment: no dose adjustment is required in patients with hepatic impairment.
Blandt entecavir-behandlede patienter, der ikke tidligere har været behandlet med nukleosid, var den gennemsnitlige tid til eksacerbation efter behandling 23 - 24 uger, og de fleste tilfælde blev indberettet blandt HBeAg-negative patienter (se pkt.
Among entecavir-treated nucleoside naive patients, post-treatment exacerbations had a median time to onset of 23-24 weeks, and most were reported in HBeAg negative patients (see section 4.8).
For lamivudin (n = 355) var de kumulative responsrater 39% for HBV-DNA < 300 kopier/ml ved PCR, 79% for ALAT-normalisering, 26% for HBeAg-serokonvertering og 2% for HBsAg-serokonvertering (3% for tab af HBsAg).
For lamivudine (n = 355), cumulative response rates were 39% for HBV DNA < 300 copies/ml by PCR, 79% for ALT normalisation, 26% for HBeAg seroconversion, and 2% for HBsAg seroconversion (3% for HBsAg loss).
Entecavir-TP Ki for HBV-DNA polymerase er 0,0012 μM.
polymerase is 0.0012 μM.
inkompenseret leversygdom (se pkt.
decompensated liver disease (see section 4.4)
Stigningerne svandt generelt ved fortsat behandling og de var, i de fleste tilfælde, forbundet med en ≥ 2 log10/ml reduktion i viral load, der gik forud for eller faldt sammen med ALAT-stigningen.
Among entecavir-treated patients, on-treatment ALT elevations had a median time to onset of 4-5 weeks, generally resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10/ml reduction in viral load that preceded or coincided with the ALT elevation.
Der sås ETVr-substitutioner (foruden LVDr-substitutioner rtM204V/I ± rtL180M) ved baseline i isolater fra 10/187 (5%) lamivudinrefraktære patienter, der blev behandlet med entecavir og monitoreret for resistens.
ETVr substitutions (in addition to LVDr substitutions rtM204V/I ± rtL180M) were observed at baseline in isolates from 10/187 (5%) lamivudine-refractory patients treated with entecavir and monitored for resistance, indicating that prior lamivudine treatment can select these resistance substitutions and that they can exist at a low frequency before entecavir treatment.
10,7%e
10.7% e 27% e 41.3% e
For de 77 patienter, som fortsatte entecavirbehandling ud over de 52 uger (i gennemsnit 96 uger), havde 40% af patienterne HBV-DNA < 300 kopier/ml ved PCR, og 81% af patienterne havde ALATnormalisering (≤ 1 gange ULN) ved behandlingens afslutning.
For the 77 patients who continued entecavir treatment beyond 52 weeks (median 96 weeks), 40% of patients had HBV DNA < 300 copies/ml by PCR and 81% had ALT normalisation (≤ 1 times ULN) at end of dosing.
5.2), kan samtidig administration med præparater, der reducerer nyrefunktionen eller konkurrerer med hensyn til aktiv tubulær udskillelse, forøge serumkoncentrationen af de respektive præparater.
Since entecavir is predominantly eliminated by the kidney (see section 5.2), coadministration with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of either medicinal product.
Adefovirdipivo xil 10 mg en gang dagligt
Adefovir Dipivoxil 10 mg once daily