natgillin/translations-raw huggingface dataset:
Den kumulative dødelighed i studiet var 23% (23/102) og 33% (29/89) for patienter, der blev behandlet med henholdsvis entecavir og adefovirdipivoxil, og den kumulative forekomst af HCC var 12% (12/102) og 20% (18/89) for henholdsvis entecavir og adefovirdipivoxil.
The time to onset of HCC or death (whichever occurred first) was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with entecavir and adefovir dipivoxil, respectively, and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for entecavir and adefovir dipivoxil, respectively.
HBV-DNA < 50 IE/ml og HBeAg-serokonverteringa HBV-DNA < 50 IE/ml a
HBV DNA < 50 IU/mL and HBeAg seroconversion a
(ng/ml) (CV%)
Cmax (ng/ml) (CV%)
Det vil sige, enten efter 48 uger eller i løbet af det andet år med behandling.
Treatment was discontinued when prespecified response criteria were met either at 48 weeks or during the second year of treatment.
Hos HBeAg-positive pædiatriske patienter bør behandlingen administreres i mindst 12 måneder efter at have opnået ikke-detekterbart HBV-DNA og HBeAg-serokonvertering (tab af HBeAg og anti-HBe-detektion ved 2 på hinanden følgende serumprøver med mindst 3-6 måneders mellemrum) eller indtil HBs-serokonvertering, eller indtil behandlingen ikke virker.
In HBeAg positive paediatric patients, treatment should be administered for at least 12 months after achieving undetectable HBV DNA and HBeAg seroconversion (HBeAg loss and anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy.
Humant immundefektvirus (hiv)/HBV-inficererede patienter som ikke samtidig får antiretroviral behandling: Entecavir er ikke blevet evalueret hos hiv/HBV-inficerede patienter, som ikke samtidig får effektiv hiv-behandling.
Human immunodeficiency virus (HIV)/HBV co-infected patients not receiving concomitant antiretroviral therapy: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Hos HBeAg-negative pædiatriske patienter bør behandlingen administreres indtil HBs-serokonvertering, eller indtil behandlingen ikke virker.
In HBeAg negative paediatric patients, treatment should be administered until HBs seroconversion or there is evidence of loss of efficacy.
HBeAg-positive voksne patienter skal behandles mindst indtil 12 måneder efter, de har opnået HBe-serokonvertering (tab af HBeAg og HBV-DNA med påvisning af anti-HBe ved 2 på hinanden følgende serumprøver med mindst 3-6 måneders mellemrum) eller indtil HBsserokonvertering, eller indtil behandlingen ikke virker (se pkt.
In HBeAg positive adult patients, treatment should be administered at least until 12 months after achieving HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Tabletovertræk:
Tablet core:
HBV-DNA < 300 kopier/ml, og 49/57 (86%) havde serum ALAT ≤ 1 gange ULN.
At the time of the long-term biopsy, all patients had HBV DNA < 300 copies/ml and 49/57 (86%) had serum ALT ≤ 1 times ULN.
Blisterpakninger: EU/1/17/1211/005 EU/1/17/1211/006
Blister packs: EU/1/17/1211/005 EU/1/17/1211/006
hiv/HBV-inficerede patienter, som ikke samtidig får HAART-behandling: Entecavir er ikke blevet evalueret hos hiv/HBV-inficerede patienter, der ikke samtidig fik effektiv hiv-behandling.
HIV/HBV co-infected patients not receiving concomitant HAART: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Er du i tvivl, så spørg lægen eller apoteket.
If you have any further questions, ask your doctor or pharmacist.
Akut hepatitis-eksacerbation er ligeledes indberettet hos patienter, som har seponeret hepatitis Bbehandling (se pkt.
Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy (see section 4.2).
Albumin-niveauer < 2,5 g/dl forekom hos 30% af patienterne, lipase-niveauer > 3 gange baseline hos 10% af patienterne og blodplader < 50.000/mm3 hos 20% af patienterne.
Albumin levels < 2.5 g/dl occurred in 30% of patients, lipase levels > 3 times baseline in 10% and platelets < 50,000/mm3 in 20%.
Til passende dosering af børn og unge findes Entecavir Accord oral opløsning eller Entecavir Accord 0,5 mg filmovertrukne tabletter og for doser under 0,5 mg fås en oral opløsning.
For appropriate dosing in the paediatric population, Entecavir Accord 0.5 mg film-coated tablets are available and for dosages below 0.5 mg an oral solution may be available.
Inkompenseret leversygdom
Decompensated liver disease
b. Liste i tabelform over bivirkninger
b. Tabulated list of adverse reactions
Unormale laboratorieprøver: I uge 48 havde ingen af de entecavir-behandlede patienter med inkompenseret leversygdom ALAT-forhøjelse > 10 gange ULN og > 2 gange baseline og 1% af patienterne havde ALAT-forhøjelser > 2 gange baseline og samtidig total-bilirubin > 2 gange ULN og > 2 gange baseline.
Laboratory test abnormalities: through week 48 among entecavir-treated patients with decompensated liver disease, none had ALT elevations both > 10 times ULN and > 2 times baseline, and 1% of patients had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
: søvnløshed
: anaphylactoid reaction
HBV-DNA < 50 IE/mla
ALT normalizationa HBV DNA < 50 IU/mL
Cmax og Cmin ved steady-state er henholdsvis 4,2 og 0,3 ng/ml for en dosis på 0,5 mg, og henholdsvis 8,2 og 0,5 ng/ml for 1 mg. Tabletterne og den orale opløsning var bioækvivalente hos raske frivillige, og de to former kan derfor erstatte hinanden.
Cmax and Cmin at steady-state are 4.2 and 0.3 ng/ml, respectively, for a dose of 0.5 mg, and 8.2 and 0.5 ng/ml, respectively, for 1 mg.
41,3%e 43,6%e a Resultater afspejler kombinationsbehandling med entecavir-lamivudin i gennemsnit i 13 uger (efterfulgt af længerevarende behandling med entecavir) hos 48 ud af 80 patienter i År 3, i gennemsnit 38 uger for 10 ud af
43.6% e a Results reflect use of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 13 weeks for 48 of 80 patients in Year 3, a median of 38 weeks for 10 of 52 patients in Year 4, and for 16 weeks for 1 of 33 patients in Year 5 in a rollover study.
For patienter med lamivudin-refraktær hepatitis B, se pkt.
For patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
I studier med lamivudin-refraktære patienter sås under behandling ALAT-stigninger > 10 gange ULN og > 2 gange baseline hos 2% af entecavir-behandlede patienter vs. 11% af lamivudin-behandlede patienter.
In studies with lamivudine-refractory patients, on treatment ALT elevations > 10 times ULN and > 2 times baseline occurred in 2% of entecavir treated patients vs 11% of lamivudine treated patients.
Erfaring hos patienter med kompenseret leversygdom, der ikke tidligere har været i nukleosidbehandling:
Experience in nucleoside-naive patients with compensated liver disease:
5.1) hos voksne med: kompenseret leversygdom og tegn på aktiv virusreplikation, vedvarende forhøjet serumalaninaminotransferase (ALAT) og histologisk påvist aktiv inflammation og/eller fibrose.
Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Det skal du vide, før du begynder at tage Entecavir Accord Sådan skal du tage Entecavir Accord Bivirkninger
What Entecavir Accord is and what it is used for What you need to know before you take Entecavir Accord How to take Entecavir Accord Possible side effects
Unormale laboratorieprøver: I kliniske studier med nukleosid-naive patienter havde 5 % ALATstigninger > 3 gange baseline, og < 1% havde forhøjet ALAT > 2 gange baseline samt total-bilirubin > 2 gange den øvre normalgrænse (ULN) og > 2 gange baseline.
Laboratory test abnormalities: In clinical studies with nucleoside-naive patients, 5% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times upper limit of normal (ULN) and > 2 times baseline.
LVD 100 mg én gang dagligt
LVD 100 mg once daily
Til og med Uge 240 blev der i forsøg med patienter, der ikke tidligere havde været behandlet med nukleosid, identificeret genotypeevidens for ETVr-substitutioner ved rtT184, rtS202 eller rtM250 hos 3 af patienterne, der blev behandlet med entecavir.
Through Week 240 in nucleoside-naive studies, genotypic evidence of ETVr substitutions at rtT184, rtS202, or rtM250 was identified in 3 patients treated with entecavir, 2 of whom experienced virologic breakthrough (see table).
Behandlingsvarighed
Duration of therapy
Der sås amylaseniveauer > 3 gange baseline hos 2% af patienterne, lipaseniveauer > 3 gange baseline hos 18% og trombocytter < 50.000/mm3 hos < 1%.
Amylase levels > 3 times baseline occurred in 2% of patients, lipase levels > 3 times baseline in 18% and platelets < 50,000/mm3 in < 1%.
Fald i viral load (log10 kopier/ml)c HBV-DNA kan ikke påvises (< 300 kopier/ml ved PCR)c ALAT-normalisering (≤ 1 gang ULN) HBeAg-serokonvertering
Viral load reduction (log10 copies/ml)c HBV DNA undetectable (< 300 copies/ml by PCR)c
Ved tilstedeværelse af LVDr-mutationer bør kombinationsbehandling med entecavir og et andet antiviralt stof (som ikke har krydsresistens over for hverken lamivudin eller entecavir) overvejes frem for monoterapi med entecavir (se pkt.
In the presence of LVDr mutations, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy (see section 4.4.
Albuminniveauer < 2,5 g/dl (25 g/l) forekom hos < 1% af patienterne, amylaseniveauer > 3 gange baseline hos 2%, lipaseniveauer > 3 gange baseline hos 11% samt trombocytter < 50.000/mm3 hos < 1%.
Albumin levels < 2.5 g/dl occurred in < 1% of patients, amylase levels > 3 times baseline in 2%, lipase levels > 3 times baseline in 11% and platelets < 50,000/mm3 in < 1%.
Der er i toksikologiske studier med gentagne doser til gnavere og hunde med doser ≥ 26 gange humandosis set testikelforandringer (seminiferøs tubulær degeneration).
Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥ 26 times those in humans.
Blisterpakninger: EU/1/17/1211/005 EU/1/17/1211/003
Blister packs: EU/1/17/1211/002 EU/1/17/1211/003
I kliniske forsøg med lamivudin-refraktære patienter havde 4% af patienterne ALATstigninger > 3 gange baseline; < 1% havde ALAT-stigninger > 2 gange baseline sammen med totalbilirubin > 2 gange ULN og > 2 gange baseline.
In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
HBeAg-negative (studie 027): Behandling med entecavir i op til 96 uger (n = 325) gav kumulative responsrater på 94% for HBV-DNA < 300 kopier/ml ved PCR og 89% for ALAT-normalisering versus 77% for HBV-DNA < 300 kopier/ml ved PCR og 84% for ALAT-normalisering for lamivudinbehandlede patienter (n = 313).
HBeAg negative (study 027): treatment with entecavir up to 96 weeks (n = 325) resulted in cumulative response rates of 94% for HBV DNA < 300 copies/ml by PCR and 89% for ALT normalisation versus 77% for HBV DNA < 300 copies/ml by PCR and 84% for ALT normalisation for lamivudine-treated patients (n = 313).
Så det er vigtigt, at du overholder relevante forholdsregler for at undgå at smitte andre med HBV.
So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.
På grund af den potentielle risiko for udvikling af hiv-resistens bør entecavir derfor ikke bruges i disse tilfælde (se pkt.
Therefore, entecavir should not be used in this setting due to the potential for development of HIV resistance (see section
Entecavir Accord tabletter er anti-viral medicin, som anvendes til at behandle kronisk (vedvarende) infektion med hepatitis-B virus (HBV) hos voksne.
What Entecavir Accord is and what it is used for Entecavir Accord tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B
0,5 mg én gang dagligt
0.5 mg once daily
Der er også rapporteret om forværring af hepatitis under og efter seponering af behandling med entecavir (se pkt.
Exacerbations of hepatitis during and after discontinuation of entecavir therapy have also been reported (see section 4.4 and c. Description of selected adverse reactions).
Entecavir Accord 0,5 mg filmovertrukne tabletter Entecavir Accord 1 mg filmovertrukne tabletter
Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets
Hver tablet indeholder entecavirmonohydrat svarende til 1 mg entecavir.
Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Entecavir Accord 0,5 mg filmovertrukne tabletter: Hvide til råhvide, trekantede, bikonvekse filmovertrukne tabletter præget med 'J' på den ene side og '110' på den anden side.
Entecavir Accord 0.5 mg film-coated tablets: White to off white, triangle shaped, biconvex filmcoated tablets debossed with ‘J' on one side and ‘110' on other side.
Hos patienter med både inkompenseret leversygdom og lamivudin-resistent HBV bør kombinationsbehandling med entecavir og et andet antiviralt stof (som ikke har krydsresistens over for enten lamivudin eller entecavir) overvejes frem for monoterapi med entecavir.
Therefore, in patients with both decompensated liver disease and lamivudine-resistant HBV, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy.
HBeAg-positive (studie 026): Behandling med entecavir i op til 96 uger (n = 141) gav kumulative responsrater på 30% for HBV-DNA < 300 kopier/ml ved PCR og 85% for ALAT-normalisering og 17% for HBeAg-serokonvertering.
HBeAg positive (study 026): treatment with entecavir for up to 96 weeks (n = 141) resulted in cumulative response rates of 30% for HBV DNA < 300 copies/ml by PCR, 85% for ALT normalisation and 17% for HBeAg seroconversion.
Ved opstart af behandling hos patienter med dokumenteret lamivudin-resistent HBV i anamnesen bør kombinationsbehandling med entecavir og et andet antiviralt stof (som ikke har krydsresistens over for hverken lamivudin eller entecavir) overvejes frem for monoterapi med entecavir.
When starting therapy in patients with a documented history of lamivudine-resistant HBV, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy.
ETV 1 mg en gang dagligt
ETV 1 mg once daily
LVD 100 mg én gang dagligt n
LVD 100 mg once daily n
1 mg en gang dagligt
1 mg once daily
Entecavir Accord 1 mg tabletter entecavir
Entecavir Accord 1 mg tablets entecavir
Entecavir Accord 1 mg filmovertrukne tabletter: Pink, trekantede, bikonvekse filmovertrukne tabletter præget med 'J' på den ene side og '111' på den anden side.
Entecavir Accord 1 mg film-coated tablets: Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side.
De bivirkninger, der blev observeret hos pædiatriske forsøgspersoner, som fik behandling med entecavir, var de samme som de bivirkninger, der blev observeret hos voksne i kliniske forsøg med entecavir (se a. Oversigt over sikkerhedsprofilen og pkt.
The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults.
Hver tablet indeholder entecavirmonohydrat svarende til 0,5 mg entecavir.
Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
tal med lægen, hvis du tidligere har modtaget behandling for kronisk hepatitis B.
if you have previously received treatment for chronic hepatitis B, please inform your doctor.
Hvis du bemærker ændringer i symptomer, efter at behandlingen er stoppet, skal du straks fortælle det til lægen.
Tell your doctor immediately about any changes in symptoms that you notice after stopping treatment.
Lyserød, trekantformet, bikonveks filmovertrukket tablet præget med “J” på den ene side og “111” på den anden.
Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side.
Efter justering for forskelle i kreatinin-clearance og kropsvægt havde ældre patienter 12,5% højere AUC end yngre patienter.
After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects.The population pharmacokinetic analysis covering patients in the age range 1675 years did not identify age as significantly influencing entecavir pharmacokinetics.
Svær behandlet med hæmodialyse
Severe Managed with Haemodialysis
HBeAg-negative voksne patienter skal behandles mindst indtil HBs-serokonvertering, eller indtil behandlingen ikke virker.
In HBeAg negative adult patients, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
ALAT (≤1 X ULN)b
f ALT (≤1 X ULN)
Eksacerbationer under behandling: I studier med patienter, der ikke tidligere har været behandlet med nukleosid, sås under behandling ALAT-stigninger > 10 gange ULN og > 2 gange baseline hos 2% af de entecavir-behandlede patienter vs. 4% af de lamivudin-behandlede patienter.
Exacerbations during treatment: in studies with nucleoside naive patients, on treatment ALT elevations > 10 times ULN and > 2 times baseline occurred in 2% of entecavir treated patients vs 4% of lamivudine treated patients.
Tab af HBsAg b
HBsAg lossb Normalization of:
: forhøjede aminotransferaser Hud og subkutane væv: ikke almindelig : udslæt, alopeci Almene symptomer og reaktioner på administrationsstedet: almindelig
Nervous system disorders: common : headache, dizziness, somnolence Gastrointestinal disorders: common : vomiting, diarrhoea, nausea, dyspepsia Hepatobiliary disorders: common : increased transaminases Skin and subcutaneous tissue disorders: uncommon : rash, alopecia General disorders and administration site conditions: common : fatigue
Entecavir Accord 0,5 mg tabletter entecavir
Entecavir Accord 0.5 mg tablets entecavir
ETV 0,5 mg én gang dagligt
ETV 0.5 mg once daily
År 4 og 5 og i kombinationsbehandling med entecavir-lamivudin (efterfulgt af længerevarende entecavirbehandling) i gennemsnitlig 20 uger hos 130 ud af 149 patienter i År 3 og i 1 uge for 1 ud af 121 patienter i År 4 i et rollover-forsøg.
- genotypic ETVr c with virologic breakthrough d a Results reflect use of a 1-mg dose of entecavir for 147 of 149 patients in Year 3 and all patients in Years 4 and 5 and of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 20 weeks for 130 of 149 patients in Year 3 and for 1 week for 1 of 121 patients in Year 4 in a rollover study.
0,05 mg én gang dagligt* ELLER 0,5 mg hver 5.-7. dag
0.05 mg once daily* OR 0.5 mg every 5-7 days
HBeAg-positive (studie 022): Behandling med entecavir i op til 96 uger (n = 354) gav kumulative responsrater på 80% for HBV-DNA < 300 kopier/ml ved PCR, 87% for ALAT-normalisering, 31% for HBeAg-serokonvertering og 2% for HBsAg-serokonvertering (5% for tab af HBsAg).
HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Adefovirdipivo xil 10 mg en gang dagligt n
Adefovir Dipivoxil 10 mg once daily n HBV DNA
Kreatinin-clearance ved baseline (ml/min) Normal
Baseline Creatinine Clearance (ml/min) Unimpaired
Entecavir Accord 1 mg filmovertrukne tabletter Hypromellose
Entecavir Accord 1 mg film-coated tablets Hypromellose
Hepatitis-eksacerbationer: Spontane eksacerbationer ved kronisk hepatitis B er relativt hyppige og karakteriseres ved forbigående stigninger i serum-ALAT.
Exacerbations of hepatitis: spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Hvid til råhvid trekantformet, bikonveks filmovertrukket tablet præget med “J” på den ene side og “110” på den anden.
White to off white, triangle shaped, biconvex film-coated tablets debossed with ‘J' on one side and ‘110' on other side.
Entecavir Accord 1 mg filmovertrukne tabletter Hver tablet indeholder entecavirmonohydrat svarende til 1 mg entecavir.
Entecavir Accord 1 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Beholder: 30 filmovertrukne tabletter
30 film-coated tablets
: anafylaktoid reaktion Psykiske forstyrrelser: almindelig
Psychiatric disorders: common : insomnia
4.4 og 5.1): Anbefalet dosis til voksne er 1 mg, én gang dagligt, som skal tages på tom mave (mere end 2 timer før og mere end 2 timer efter et måltid) (se pkt.
Lamivudine-refractory patients (i.e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose in adults is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Entecavir Accord 0,5 mg filmovertrukne tabletter Hypromellose
Entecavir Accord 0.5 mg film-coated tablets Hypromellose
Blandt patienter, som fortsatte behandling ud over 52 uger (i gennemsnit 96 uger), havde 81% af de 243 entecavir-behandlede og 39% af de 164 lamivudin-behandlede patienter HBV-DNA < 300 kopier/ml ved PCR ved behandlingens afslutning.
At end of dosing, among patients who continued treatment beyond 52 weeks (median of 96 weeks), 81% of 243 entecavir-treated and 39% of 164 lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR while ALT normalisation (≤ 1 times ULN) occurred in 79% of entecavirtreated and 68% of lamivudine-treated patients.
0,3 mg én gang dagligt* ELLER 0,5 mg hver 48. time
0.3 mg once daily* OR 0.5 mg every 48 hours
Entecavir Accord 0,5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder entecavirmonohydrat svarende til 0,5 mg entecavir.
Entecavir Accord 0.5 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir .
For patienter, der oprindelig blev allokeret til entecavir, var fald i HBV-DNA ved 48 uger -4,20 log10 kopier/ml.
For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Svær
Severe
0,25 mg én gang dagligt* ELLER 0,5 mg hver 48. time
0.25 mg once daily* OR 0.5 mg every 48 hours
Gennemsnitlig serum-HBV-DNA ved PCR var 7,83 log10 kopier/ml, og gennemsnitlig serumALAT var 100 E/l.
Mean serum HBV DNA by PCR was 7.83 log10 copies/ml and mean serum ALT was 100 U/l; 54% of patients were HBeAg positive, and 35% of patients had LVDr substitutions at baseline.
0,15 mg én gang dagligt* ELLER 0,5 mg hver 72. time
0.15 mg once daily* OR 0.5 mg every 72 hours
0,1 mg én gang dagligt* ELLER 0,5 mg hver 72. time
0.1 mg once daily* OR 0.5 mg every 72 hours
Entecavir Accord 1 mg filmovertrukne tabletter entecavir
Entecavir Accord 1 mg film-coated tablets entecavir
Hvis entecavir administreres samtidig med sådanne præparater, bør patienten monitoreres tæt for bivirkninger.
Patients should be monitored closely for adverse reactions when entecavir is coadministered with such medicinal products.
4.2, 4.4 og 5.1.
Year 1 Year 2 Year 3a Year 4a Year 5a