FrancophonIA/ELRC3.0 huggingface dataset:
English: Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy (see section 4.2).
Danish: Akut hepatitis-eksacerbation er ligeledes indberettet hos patienter, som har seponeret hepatitis Bbehandling (se pkt.
English: 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%.
Danish: 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.
English: 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.
Danish: 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.
English: Decompensated liver disease
Danish: Inkompenseret leversygdom
English: b. Tabulated list of adverse reactions
Danish: b. Liste i tabelform over bivirkninger
English: 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.
Danish: 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.
English: : anaphylactoid reaction
Danish: : søvnløshed
English: ALT normalizationa HBV DNA < 50 IU/mL
Danish: HBV-DNA < 50 IE/mla
English: 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.
Danish: 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.
English: 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.
Danish: 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
English: For patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Danish: For patienter med lamivudin-refraktær hepatitis B, se pkt.
English: 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.
Danish: 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.
English: Experience in nucleoside-naive patients with compensated liver disease:
Danish: Erfaring hos patienter med kompenseret leversygdom, der ikke tidligere har været i nukleosidbehandling:
English: 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.
Danish: 5.1) hos voksne med: kompenseret leversygdom og tegn på aktiv virusreplikation, vedvarende forhøjet serumalaninaminotransferase (ALAT) og histologisk påvist aktiv inflammation og/eller fibrose.
English: 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
Danish: Det skal du vide, før du begynder at tage Entecavir Accord Sådan skal du tage Entecavir Accord Bivirkninger
English: 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.
Danish: 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.
English: LVD 100 mg once daily
Danish: LVD 100 mg én gang dagligt
English: 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).
Danish: 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.
English: Duration of therapy
Danish: Behandlingsvarighed
English: Amylase levels > 3 times baseline occurred in 2% of patients, lipase levels > 3 times baseline in 18% and platelets < 50,000/mm3 in < 1%.
Danish: Der sås amylaseniveauer > 3 gange baseline hos 2% af patienterne, lipaseniveauer > 3 gange baseline hos 18% og trombocytter < 50.000/mm3 hos < 1%.
English: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (< 300 copies/ml by PCR)c
Danish: 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
English: 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.
Danish: 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.
English: 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%.
Danish: 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%.
English: Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥ 26 times those in humans.
Danish: Der er i toksikologiske studier med gentagne doser til gnavere og hunde med doser ≥ 26 gange humandosis set testikelforandringer (seminiferøs tubulær degeneration).
English: Blister packs: EU/1/17/1211/002 EU/1/17/1211/003
Danish: Blisterpakninger: EU/1/17/1211/005 EU/1/17/1211/003
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: Så det er vigtigt, at du overholder relevante forholdsregler for at undgå at smitte andre med HBV.
English: Therefore, entecavir should not be used in this setting due to the potential for development of HIV resistance (see section
Danish: På grund af den potentielle risiko for udvikling af hiv-resistens bør entecavir derfor ikke bruges i disse tilfælde (se pkt.
English: 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
Danish: Entecavir Accord tabletter er anti-viral medicin, som anvendes til at behandle kronisk (vedvarende) infektion med hepatitis-B virus (HBV) hos voksne.
English: 0.5 mg once daily
Danish: 0,5 mg én gang dagligt
English: 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).
Danish: Der er også rapporteret om forværring af hepatitis under og efter seponering af behandling med entecavir (se pkt.
English: Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets
Danish: Entecavir Accord 0,5 mg filmovertrukne tabletter Entecavir Accord 1 mg filmovertrukne tabletter
English: Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Danish: Hver tablet indeholder entecavirmonohydrat svarende til 1 mg entecavir.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: ETV 1 mg once daily
Danish: ETV 1 mg en gang dagligt
English: LVD 100 mg once daily n
Danish: LVD 100 mg én gang dagligt n
English: 1 mg once daily
Danish: 1 mg en gang dagligt
English: Entecavir Accord 1 mg tablets entecavir
Danish: Entecavir Accord 1 mg tabletter entecavir
English: 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.
Danish: Entecavir Accord 1 mg filmovertrukne tabletter: Pink, trekantede, bikonvekse filmovertrukne tabletter præget med 'J' på den ene side og '111' på den anden side.
English: The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults.
Danish: 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.
English: Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Danish: Hver tablet indeholder entecavirmonohydrat svarende til 0,5 mg entecavir.
English: if you have previously received treatment for chronic hepatitis B, please inform your doctor.
Danish: tal med lægen, hvis du tidligere har modtaget behandling for kronisk hepatitis B.
English: Tell your doctor immediately about any changes in symptoms that you notice after stopping treatment.
Danish: Hvis du bemærker ændringer i symptomer, efter at behandlingen er stoppet, skal du straks fortælle det til lægen.
English: Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side.
Danish: Lyserød, trekantformet, bikonveks filmovertrukket tablet præget med “J” på den ene side og “111” på den anden.
English: 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.
Danish: Efter justering for forskelle i kreatinin-clearance og kropsvægt havde ældre patienter 12,5% højere AUC end yngre patienter.
English: Severe Managed with Haemodialysis
Danish: Svær behandlet med hæmodialyse
English: In HBeAg negative adult patients, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
Danish: HBeAg-negative voksne patienter skal behandles mindst indtil HBs-serokonvertering, eller indtil behandlingen ikke virker.
English: f ALT (≤1 X ULN)
Danish: ALAT (≤1 X ULN)b
English: 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.
Danish: 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.
English: HBsAg lossb Normalization of:
Danish: Tab af HBsAg b
English: 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
Danish: : forhøjede aminotransferaser Hud og subkutane væv: ikke almindelig : udslæt, alopeci Almene symptomer og reaktioner på administrationsstedet: almindelig
English: Entecavir Accord 0.5 mg tablets entecavir
Danish: Entecavir Accord 0,5 mg tabletter entecavir
English: ETV 0.5 mg once daily
Danish: ETV 0,5 mg én gang dagligt
English: - 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.
Danish: 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.
English: 0.05 mg once daily* OR 0.5 mg every 5-7 days
Danish: 0,05 mg én gang dagligt* ELLER 0,5 mg hver 5.-7. dag
English: 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).
Danish: 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).
English: Adefovir Dipivoxil 10 mg once daily n HBV DNA
Danish: Adefovirdipivo xil 10 mg en gang dagligt n
English: Baseline Creatinine Clearance (ml/min) Unimpaired
Danish: Kreatinin-clearance ved baseline (ml/min) Normal
English: Entecavir Accord 1 mg film-coated tablets Hypromellose
Danish: Entecavir Accord 1 mg filmovertrukne tabletter Hypromellose
English: 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).
Danish: Hepatitis-eksacerbationer: Spontane eksacerbationer ved kronisk hepatitis B er relativt hyppige og karakteriseres ved forbigående stigninger i serum-ALAT.
English: White to off white, triangle shaped, biconvex film-coated tablets debossed with ‘J' on one side and ‘110' on other side.
Danish: Hvid til råhvid trekantformet, bikonveks filmovertrukket tablet præget med “J” på den ene side og “110” på den anden.
English: Entecavir Accord 1 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Danish: Entecavir Accord 1 mg filmovertrukne tabletter Hver tablet indeholder entecavirmonohydrat svarende til 1 mg entecavir.
English: 30 film-coated tablets
Danish: Beholder: 30 filmovertrukne tabletter
English: Psychiatric disorders: common : insomnia
Danish: : anafylaktoid reaktion Psykiske forstyrrelser: almindelig
English: 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).
Danish: 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.
English: Entecavir Accord 0.5 mg film-coated tablets Hypromellose
Danish: Entecavir Accord 0,5 mg filmovertrukne tabletter Hypromellose
English: 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.
Danish: 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.
English: 0.3 mg once daily* OR 0.5 mg every 48 hours
Danish: 0,3 mg én gang dagligt* ELLER 0,5 mg hver 48. time
English: Entecavir Accord 0.5 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir .
Danish: Entecavir Accord 0,5 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder entecavirmonohydrat svarende til 0,5 mg entecavir.
English: 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.
Danish: For patienter, der oprindelig blev allokeret til entecavir, var fald i HBV-DNA ved 48 uger -4,20 log10 kopier/ml.
English: Severe
Danish: Svær
English: 0.25 mg once daily* OR 0.5 mg every 48 hours
Danish: 0,25 mg én gang dagligt* ELLER 0,5 mg hver 48. time
English: 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.
Danish: Gennemsnitlig serum-HBV-DNA ved PCR var 7,83 log10 kopier/ml, og gennemsnitlig serumALAT var 100 E/l.
English: 0.15 mg once daily* OR 0.5 mg every 72 hours
Danish: 0,15 mg én gang dagligt* ELLER 0,5 mg hver 72. time
English: 0.1 mg once daily* OR 0.5 mg every 72 hours
Danish: 0,1 mg én gang dagligt* ELLER 0,5 mg hver 72. time
English: Entecavir Accord 1 mg film-coated tablets entecavir
Danish: Entecavir Accord 1 mg filmovertrukne tabletter entecavir
English: Patients should be monitored closely for adverse reactions when entecavir is coadministered with such medicinal products.
Danish: Hvis entecavir administreres samtidig med sådanne præparater, bør patienten monitoreres tæt for bivirkninger.
English: Year 1 Year 2 Year 3a Year 4a Year 5a
Danish: 4.2, 4.4 og 5.1.
English: Tumour development was preceded by pneumocyte proliferation in the lung which was not observed in rats, dogs, or monkeys, indicating that a key event in lung tumour development observed in mice likely was species-specific.
Danish: I 2-årige carcinogenicitetsstudier med hanmus sås stigninger i forekomst af lungetumorer ved doser ≥ 4 og ≥ 2 gange humandosis ved henholdsvis 0,5 mg og 1 mg. Tumorudviklingen blev forudgået af pneumocytproliferation i lungen, som ikke observeredes hos rotter, hunde eller aber, hvilket tyder på at nøglehændelsen i udviklingen af lungetumorer hos mus sandsynligvis er artsspecifik.
English: Entecavir Accord 1 mg film-coated tablets
Danish: Entecavir Accord 1 mg filmovertrukne tabletter
English: Entecavir Accord 0.5 mg film-coated tablets entecavir
Danish: Entecavir Accord 0,5 mg filmovertrukne tabletter entecavir
English: Entecavir Accord 1 mg film-coated tablets Bottle packs:
Danish: Entecavir Accord 1 mg filmovertrukne tabletter Beholdere:
English: Entecavir Accord 0.5 mg film-coated tablets
Danish: Entecavir Accord 0,5 mg filmovertrukne tabletter
English: Entecavir Accord 0.5 mg film-coated tablets Bottle packs:
Danish: Entecavir Accord 0,5 mg filmovertrukne tabletter Beholdere:
English: The entecavir-TP Ki for HBV DNA
Danish: HBV-DNAa
English: Each 0.5 mg film-coated tablet contains 26 mg soy polysaccharides.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver 0,5 mg tablet indeholder 26 mg sojapolysakkarider.
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)
Danish: Ikke-detekterbart niveau (<300 kopier/ml)b
English: With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1.
Danish: Angående beslutningen om at initiere behandling hos pædiatriske patienter henvises til pkt.
English: virus (HBV) infection in adults.
Danish: Det er muligt at blive vaccineret mod HBV.
English: Posology
Danish: Tabletovertræk
English: Entecavir Accord tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Danish: HBV hos børn og unge i alderen 2-18 år.
English: Do not use IVEMEND:
Danish: Brug ikke IVEMEND:
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 11 January 2013
Danish: Dato for første markedsføringstilladelse: 11. januar 2008 Dato for seneste fornyelse: 11. januar 2013