natgillin/translations-raw huggingface dataset:
Entecavir Mylan må ikke anvendes under graviditet undtagen, hvis lægen har ordineret det til dig.
Entecavir Mylan must not be used during pregnancy unless specifically directed by your doctor.
Nedsat leverfunktion: Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion.
Hepatic impairment: no dose adjustment is required in patients with hepatic impairment.
Entecavir Mylan tabletter er anti-viral medicin, som anvendes til at behandle kronisk (vedvarende) infektion med hepatitis-B virus (HBV) hos voksne.
Entecavir Mylan tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults.
Opståen af entecavir genotype-resistens til og med År 5 i studier med nukleosid-naive patienter
Emerging Genotypic Entecavir Resistance Through Year 5, Nucleoside-Naïve Studies
Ikke-detekterbar niveau (<300 kopier/ml)b Gennemsnitlig ændring fra baseline (log10 kopier/ml)c
Proportion undetectable (<300 copies/ml)b Mean change from baseline (log10 copies/ml)c
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 studier med entecavir (se 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 (see Summary of the safety profile and section 5.1).
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.
Relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Efter levertransplantation
Post-Liver transplant
Børn, der vejer mindst 32,6 kg kan bruge 0,5 tabletten, eller der findes en en oral opløsning.
Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available.
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.
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).
Til passende dosering af den pædiatriske population findes Entecavir Mylan 0,5 mg filmovertrukne tabletter og til doser under 0,5 mg en oral opløsning.
For appropriate dosing in the paediatric population Entecavir Mylan 0.5 mg Film-coated Tablets are available and for doses below 0.5 mg an oral solution may be available.
Toksikologiske studier med dyr, der fik entecavir, har ikke vist nedsat fertilitet (se pkt.
Toxicology studies in animals administered entecavir have shown no evidence of impaired fertility (see section 5.3).
Justering af dosis anbefales til patienter med nyreinsufficiens (se pkt.
Dosage adjustment is recommended for patients with renal impairment (see section 4.2).
OPA/Aluminium/PVC-Aluminium perforeret enkeltdosisblisterpakning med 30 x 1 eller 90 x 1 filmovertrukne tabletter.
OPA/Aluminium/PVC-Aluminium perforated unit-dose foil blister packs containing 30 x 1 or 90 x 1 film-coated tablets.
Blandt entecavir-behandlede patienter var den gennemsnitlige tid til ALAT-stigninger under behandling 4-5 uger.
Among entecavir-treated patients ontreatment exacerbations had a median time of onset of 4-5 weeks.
Det vides ikke, om entecavir udskilles i modermælk.
It is unknown whether entecavir is excreted in human milk.
AUC(0-T) (ng·t /ml) (CV)
AUC(0-T) (ng·h /ml) (CV)
90 x 1 filmovertrukket tablet
90 x 1 film-coated tablets
Erfaring med patienter med samtidig hiv-infektion
Experience in patients co-infected with HIV
Tabellen viser entecavirs farmakokinetik efter en 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:
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.
Tabellen viser resultater efter 48 uger fra randomiserede, dobbeltblinde studier, 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.
Cmax, AUC (0-24) og Cmin for disse forsøgspersoner var henholdsvis 14,48 ng/ml, 38,58 ng·t/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.
4.2 Dosering og administration Behandlingen skal initieres af en læge med erfaring i behandling af kronisk hepatitis B-infektion.
Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
- genotype-ETVr c med virologisk svigtd a Resultater afspejler brug af 1 mg dosis af entecavir hos 147 ud af 149 patienter i År 3 og hos alle patienter i 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-studie.
Cumulative probability of: - emerging genotypic ETVr c - 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.
Responset opretholdtes hos 75% (83/111) af entecavir-respondere versus 73% (68/93) af lamivudin-respondere i studie 022 og hos 46% (131/286) af entecavir-respondere versus 31% (79/253) af lamivudin-respondere i studie 027.
For patients who met protocol-defined response criteria, response was sustained throughout the 24-week 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.
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.
Cmax, AUC (0-24) og Cmin for disse forsøgspersoner var henholdsvis 6,31 ng/ml, 18,33 ng·t/ml og 0,28 ng/ml.
The Cmax, AUC (0-24), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.
Øget forekomst af andre tumorer, inklusive 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.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Tablet
PHARMACEUTICAL FORM AND CONTENTS Tablet
År 2 År 3a
Year 1 Year 2 Year 3a Year 4 a Year 5a
Hver filmovertrukket tablet indeholder 62,5 mg lactosemonohydrat.
Each film-coated tablet contains 62.5 mg lactose monohydrate.
Hvis du har taget for mange Entecavir Mylan tabletter Du skal straks kontakte lægen.
If you take more Entecavir Mylan than you should Contact your doctor at once.
Det skal du vide, før du begynder at tage Entecavir Mylan 3.
What you need to know before you take Entecavir Mylan 3.
Eksacerbationer under behandling
Exacerbations during treatment
Hvis du har glemt at tage Entecavir Mylan
If you forget to take Entecavir Mylan
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.
I en mindre gruppe patienter med hiv/HBV-infektion i HAART-regimer (highly active antiretroviral therapy) der omfattede lamivudin, svarede entecavirs sikkerhedsprofil til den hos monoinficerede HBV-patienter (se pkt.
The safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudinecontaining HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (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.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERPAKNING
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Baseline HBV-DNA
Baseline HBV
Hver filmovertrukket tablet indeholder 125 mg lactosemonohydrat.
Each film-coated tablet contains 125 mg lactose monohydrate.
Brug af Entecavir Mylan sammen med mad og drikke De fleste kan tage Entecavir Mylan med eller uden mad.
In most cases you may take Entecavir Mylan with or without food.
Patienter med inkompenseret leversygdom
Patients with decompensated liver disease
• 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 to 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.
ALAT (≤1 X ULN)b
ALT (≤1 X ULN)b
30 x 1 filmovertrukket tablet
30 x 1 film-coated tablets
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).
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.
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).
Du må ikke amme, mens du er i behandling med Entecavir Mylan.
You should not breast-feed during treatment with Entecavir Mylan.
Entecavir Mylan fås kun som 0,5 mg og 1 mg filmovertrukne tabletter.
Entecavir Mylan is only available as 0.5 and 1 mg film-coated tablets.
Erfaring hos lamivudin-refraktære patienter med kompenseret leversygdom
Experience in lamivudine-refractory patients with compensated liver disease
Entecavir er ikke blevet evalueret hos hiv/HBV-inficerede patienter, som ikke samtidig får effektiv hiv-behandling.
Entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• HBeAg-positive voksne patienter skal behandles i mindst 12 måneder efter, de har opnået HBe-serokonvertering (tab af HBeAg og HBV-DNA med påvisning af anti-HBe ved to 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).
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 gang 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.
Det vides ikke, om det er sikkert at bruge Entecavir Mylan under graviditet.
It has not been demonstrated that entecavir is safe to use during pregnancy.
Sådan skal du tage Entecavir Mylan 4.
How to take Entecavir Mylan 4.
Entecavir Mylan indeholder lactose
Entecavir Mylan contains lactose
• Hos HBeAg-negative pædiatriske patienter bør behandlingen administreres indtil HBsserokonvertering, 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.
Moderat (n = 6)
Moderate (n = 6)
- genotype-ETVr c med virologisk svigtd
- genotypic ETVr with virologic breakthrough d
Der foreligger ingen data vedrørende effekten af entecavir hos HBeAg-negative patienter med samtidig hiv-infektion.
No data are available on the efficacy of entecavir in HBeAgnegative patients co-infected with HIV.
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 ALT normalisation (≤1 times ULN) HBeAg Seroconversion
blev der observeret en yderligere bivirkning [fald i blodhydrogencarbonat (2%)] hos entecavirbehandlede patienter i uge 48.
Relative to the adverse reactions noted in section Tabulated list of adverse reactions, one additional adverse reaction [decrease in blood bicarbonate (2%)] was observed in entecavir-treated patients through week 48.
Der er indberettet akutte eksacerbationer af hepatitis hos patienter, som har seponeret behandling af hepatitis B, inklusive behandling med entecavir (se pkt.
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).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL BLISTERPAKNING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Titandioxid (E171)
Titanium dioxide (E171) Hypromellose Macrogol 400
Humant immundefektvirus (hiv)/HBV-inficererede patienter som ikke samtidig får antiretroviral behandling
Human immunodeficiency virus (HIV)/HBV co-infected patients not receiving concomitant antiretroviral therapy
5.2), kan samtidig administration med præparater, der reducerer nyrefunktionen eller konkurrerer med hensyn til aktiv tubulær udskillelse, forøge serumkoncentrationen af de respektive præparater.
4.5 Interaction with other medicinal products and other forms of interaction 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.
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%.
Det skal du vide, før du begynder at tage Entecavir Mylan
What you need to know before you take Entecavir Mylan
Entecavir Mylan er indiceret til behandling af kronisk hepatitis B-virus- (HBV) infektion (se pkt.
Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with:
Patienter behandlet og monitoreret for resistensb Patienter i specifikt år med: - opståen af genotype-ETVrc - genotype-ETVrc med virologisk svigtd
Patients in specific year with: - emerging genotypic ETVr c - genotypic ETVr c with virologic breakthrough d
Adefovirdipivoxil 10 mg én gang dagligt
Adefovir Dipivoxil 10 mg once daily
Til og med Uge 240 blev der i studier 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).
Lamivudin-refraktære patienter
Lamivudine-refractory
Blandt lamivudin-refraktære patienter med baseline HBV-DNA <107 log10 kopier/ml opnåede 64% (9/14) HBV-DNA <300 kopier/ml i Uge 48.
Among lamivudine-refractory patients with baseline HBV DNA <107 log10 copies/ml, 64% (9/14)
Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included 18.
Blandt andet medregnes årsager som død, manglende virkning, bivirkning, noncompliance/manglende opfølgning som svigt (f.eks. HBV-DNA ≥300 kopier/ml)
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) d Defined as decrease or no change from baseline in CTP score.
Entecavir Mylan indeholder:
What Entecavir Mylan contains
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%.
Adefovirdipivoxil 10 mg én gang dagligt n
Adefovir Dipivoxil 10 mg once daily n
Mikrokrystallinsk cellulose Crospovidon
Microcrystalline cellulose Crospovidone Lactose monohydrate Magnesium stearate
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 Description of selected adverse reactions).
I studier med lamivudin-refraktære patienter sås under behandling ALAT-stigninger >10 gange ULN og >2 gange baseline hos 2% af entecavirbehandlede patienter versus 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.
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.
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%.
I kliniske studier med lamivudin-refraktære patienter havde 4% af patienterne ALAT-stigninger >3 gange baseline; <1% havde ALAT-stigninger >2 gange baseline sammen med total-bilirubin >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.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ENKELTDOSISBLISTERPAKNING
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER
Svær Behandlet med hæmodialyse (n = 6)
Severe Managed with Haemodialysis (n = 6)
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).
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
Tell your doctor if you are pregnant or planning to become pregnant.
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.
Lægemidlet må kun udleveres efter ordination på en særlig recept.
Medicinal product subject to restricted medical prescription.
Svær (n = 6)
Severe (n = 6)