FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, lamivudine-refractory patients who achieved HBV DNA < 104 log10 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).
Danish: 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]).
English: Baraclude 0.5 mg film-coated tablets Blister packs: EU/1/06/343/003
Danish: Baraclude 0,5 mg filmovertrukne tabletter Blisterpakninger: EU/1/06/343/003
English: High baseline Knodell necroinflammatory scores (> 10) were associated with greater histological improvement in nucleoside-naive patients.
Danish: Høje baseline Knodell nekroinflammatoriske scorer (> 10) var forbundet med større histologisk forbedring hos patienter der ikke tidligere havde været i nukleosidbehandling.
English: taking Baraclude will not stop you from infecting other people with hepatitis B virus
Danish: selvom du tager Baraclude, kan du stadig smitte andre med hepatitis-B virus (HBV)
English: The film-coated tablets (tablets) are white to off-white and triangular-shaped.
Danish: De filmovertrukne tabletter er hvide til grålighvide og trekantede.
English: This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
Danish: Lægemidlet indeholder methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216), som kan forårsage allergiske reaktioner (muligvis forsinkede).
English: Excipients with known effect 380 mg maltitol/ml 1.5 mg methylhydroxybenzoate/ml 0.18 mg propylhydroxybenzoate/ml 0.3 mg sodium/ml
Danish: 1,5 mg methylparahydroxybenzoat/ml 0,18 mg propylparahydroxybenzoat/ml 0,3 mg natrium/ml
English: For appropriate dosing in the paediatric population, Baraclude oral solution or Baraclude 0.5 mg filmcoated tablets are available.
Danish: Til passende dosering af børn og unge findes Baraclude oral opløsning eller Baraclude 0,5 mg filmovertrukne tabletter.
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelse og fremstiller
English: Baraclude contains maltitol, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216) and sodium
Danish: Baraclude indeholder maltitol, methylparahydroxybenzoat (E218), propylparahydroxybenzoat (E216) og natrium
English: Store in the original carton.
Danish: Opbevares i originalemballagen.
English: - emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd 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: - opståen af genotype-ETVrc - genotype-ETVrc med virologisk svigt d 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-forsøg.
English: The other ingredients are: citric acid anhydrous, maltitol (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), orange flavour (acacia and natural flavours), sodium citrate, sodium hydroxide, hydrochloric acid and purified water.
Danish: Øvrige indholdsstoffer: citronsyre, vandfri; maltitol (E965); methylparahydroxybenzoat (E218); propylparahydroxybenzoat (E216); appelsinsmag (akacie- og naturlige smagsstoffer), natriumcitrat, natriumhydroxid, saltsyre og renset vand.
English: HIV/HBV co-infected patients receiving concomitant HAART: study 038 included 67 HBeAg positive and 1 HBeAg negative patients co-infected with HIV.
Danish: hiv/ HBV -inficerede patienter, som samtidig får HAART-behandling: Studie 038 inkluderede 67 HBeAg-positive patienter og 1 HBeAg-negativ patient med samtidig hiv-infektion.
English: Baraclude oral solution comes with a measuring spoon with markings from 0.5 up to 10 milliliters.
Danish: Baraclude oral opløsning leveres med en måleske med rmærker fra 0,5 til 10 milliliter.
English: **on haemodialysis days, administer entecavir after haemodialysis.
Danish: **på hæmodialysedage administreres entecavir efter hæmodialysen.
English: 210 ml oral solution with a measuring spoon.
Danish: 210 ml oral opløsning med måleske
English: Package leaflet: Information for the user Baraclude 1 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Baraclude 1 mg filmovertrukne tabletter
English: Paediatric patients with body weight of at least 32.6 kg, should be administered a daily dose of one 0.5 mg tablet or 10 ml (0.5 mg) of the oral solution, with or without food.
Danish: Pædiatriske patienter med en kropsvægt på mindst 32,6 kg skal have en daglig dosis på en 0,5 mg tablet eller 10 ml (0,5 mg) oral opløsning med eller uden mad.
English: Each ml oral solution contains 0.05 mg entecavir (as monohydrate).
Danish: Hver ml oral opløsning indeholder 0,05 mg entecavir (som monohydrat).
English: Baraclude 1 mg film-coated tablets Each tablet contains 1 mg entecavir (as monohydrate).
Danish: Baraclude 1 mg filmovertrukne tabletter Hver tablet indeholder 1 mg entecavir (som monohydrat).
English: The Baraclude oral solution is recommended for patients weighing from 10 kg to 32.5 kg.Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablet.
Danish: Baraclude oral opløsning anbefales til patienter, der vejer fra 10-32,5 kg.Børn, der vejer mindst 32,6 kg kan bruge den orale opløsning eller 0,5 mg tabletten.
English: 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).
Danish: 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.
English: Outer carton: Baraclude 0.05 mg/ml
Danish: Ydre karton: Baraclude 0,05 mg/ml
English: N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Danish: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: EU/1/06/343/001 Baraclude 1 mg film-coated tablets Blister packs: EU/1/06/343/004 EU/1/06/343/007
Danish: EU/1/06/343/001 Baraclude 1 mg filmovertrukne tabletter Blisterpakninger: EU/1/06/343/004 EU/1/06/343/007
English: 10.0 ml a Body weight should be rounded to the nearest 0.1 kg. b Children with body weight at least 32.6 kg should receive 10.0 ml (0.5 mg) of oral solution or one 0.5 mg tablet once daily.
Danish: 10,0 ml a Legemsvægt bør afrundes til nærmeste 0,1 kg. b Børn med legemsvægt på mindst 32,6mg bør få 10,0 ml (0,5 mg) oral opløsning eller en 0,5 mg tablet en gang dagligt.
English: For adults the recommended dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth).
Danish: Til voksne er den anbefalede dosis 0,5 mg (10 ml) eller 1 mg (20 ml) én gang dagligt oralt (igennem munden).
English: Baraclude should not be used for children below 2 years of age or weighing less than 10 kg.
Danish: Baraclude bør ikke anvendes til børn under 2 år eller børn, der vejer under 10 kg.
English: Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG Plaza 254
Danish: Indehaver af markedsføringstilladelsen: Bristol-Myers Squibb Pharma EEIG Plaza 254
English: Package leaflet: Information for the user Baraclude 0.05 mg/ml oral solution
Danish: Indlægsseddel: Information til brugeren Baraclude 0,05 mg/ml oral opløsning
English: Outer carton: Baraclude 0.5 mg
Danish: Ydre karton: Baraclude 0,5 mg
English: EU/1/06/343/002 30 film-coated tablets
Danish: EU/1/06/343/002 30 filmovertrukne tabletter
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)
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: 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 52 patienter i År 4 og i 16 uger for 1 ud af 33 patienter i År 5 i et rollover-forsøg.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Baraclude 0.5 mg film-coated tablets Each tablet contains 0.5 mg entecavir (as monohydrate).
Danish: Baraclude 0,5 mg filmovertrukne tabletter Hver tablet indeholder 0,5 mg entecavir (som monohydrat).
English: Hepatobiliary disorders common: increased transaminases
Danish: almindelig: forhøjede aminotransferaser
English: Baraclude dosage
Danish: Baraclude-dosis٭
English: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to 1/10); uncommon (≥ 1/1,000 to < 1/100); rare(≥ 1/10,000 to < 1/1,000).
Danish: Hyppighed defineres som meget almindelig (≥ 1/10); almindelig (≥ 1/100
English: Each carton includes a measuring spoon (polypropylene) with markings from 0.5 ml up to 10 ml
Danish: Æsken indeholder en måleske (polypropylen) med angivelser fra 0,5 ml-10 ml
English: Baraclude 0.5 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Danish: Baraclude 0,5 mg filmovertrukne tabletter fås i æsker med 30 x 1 eller 90 x 1 filmovertrukket tablet (enkeltdosis-blistere) og i beholdere med 30 filmovertrukne tabletter.
English: Package leaflet: Information for the user Baraclude 0.5 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Baraclude 0,5 mg filmovertrukne tabletter
English: 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).
Danish: 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.
English: Baraclude oral solution is designed as a ready-to-use product.
Danish: Baraclude oral opløsning er lavet, så den kan anvendes som den er.
English: Excipients with known effect Each 0.5 mg film-coated tablet contains 120.5 mg lactose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver 0,5 mg tablet indeholder 120,5 mg lactose.
English: Baraclude 1 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Danish: Baraclude 1 mg filmovertrukne tabletter fås i æsker med 30 x 1 eller 90 x 1 filmovertrukket tablet (enkeltdosis-blistere) og i beholdere med 30 filmovertrukne tabletter.
English: Each ml contains 0.05 mg entecavir.
Danish: Hver ml indeholder 0,05 mg entecavir
English: decompensated liver disease (see section 4.4).
Danish: inkompenseret leversygdom (se pkt.
English: EU/1/06/343/001 30 film-coated tablets
Danish: EU/1/06/343/001 30 filmovertrukne tabletter
English: The oral solution should be used for patients with body weight less than 32.6 kg. Paediatric patients with body weight at least 32.6 kg, should be administered 10 ml (0.5 mg) of the oral solution or one 0.5 mg tablet once daily.
Danish: Den orale opløsning bør anvendes til patienter med en kropsvægt under 32,6 kg. Pædiatriske patienter med en kropsvægt på mindst 32,6 kg skal have 10 ml (0,5 mg) oral opløsning eller en 0,5 mg tablet en gang dagligt.
English: Recommended Once Daily Dose of Oral Solutionb
Danish: Anbefalet dosis af oral opløsing en gang dagligtb
English: Baraclude 0.05 mg/ml oral solution entecavir
Danish: Baraclude 0,05 mg/ml oral opløsning entecavir
English: Among lamivudine-refractory patients with baseline HBV DNA < 107 log10 copies/ml, 64% (9/14) achieved HBV DNA < 300 copies/ml at Week 48.
Danish: Blandt lamivudin-refraktære patienter med baseline HBV-DNA < 107 log10 kopier/ml opnåede 64% (9/14) HBV-DNA <300 kopier/ml i Uge 48.
English: Baraclude 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: 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.
Danish: Human immundefekt virus (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.
English: Blister packs: do not store above 30°C.
Danish: Blisterpakning: må ikke opbevares ved temperaturer over 30 °C.
English: Baraclude 1 mg tablets entecavir
Danish: Baraclude 1 mg tabletter entecavir
English: Lactose monohydrate Magnesium stearate Cellulose, Microcrystalline Povidone
Danish: Cellulose, mikrokrystallinsk Povidon
English: Baraclude 0.05 mg/ml oral solution
Danish: Baraclude 0,05 mg/ml oral opløsning
English: There are no dosing recommendations for Baraclude in children less than 2 years of age or weighing less than 10 kg.
Danish: Der er ingen dosisanbefalinger for Baraclude til børn under 2 år eller børn, der vejer under 10 kg.
English: (Year 1), after week 58 through week 102 (Year 2), after week 102 through week 156 (Year 3), after week 156 through week 204 (Year 4), or after week 204 through week 252 (Year 5).
Danish: b Inkluderer patienter med mindst én HBV-DNA-måling under behandling ved PCR ved eller efter uge 24 til og med uge 58 (År 1), efter uge 58 til og med uge 102 (År 2) eller efter uge 102 til og med uge 156 (År 3), efter uge 156 til og med uge 204 (År 4) eller efter uge 204 til og med uge 252 (År 5).
English: Baraclude 0.5 mg film-coated tablets Baraclude 1 mg film-coated tablets
Danish: Baraclude 0,5 mg filmovertrukne tabletter Baraclude 1 mg filmovertrukne tabletter
English: EU/1/06/343/003 30 x 1 film-coated tablet EU/1/06/343/006 90 x 1 film-coated tablet
Danish: Blisterpakning: EU/1/06/343/003 30 x 1 filmovertrukket tablet EU/1/06/343/006 90 x 1 filmovertrukket tablet
English: In accordance with current paediatric practice guidelines, treatment discontinuation may be considered as follows: 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.
Danish: I henhold til gældende retningslinjer for pædiatrisk behandling bør seponering af behandlingen overvejes i følgende tilfælde: 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.
English: EU/1/06/343/004 30 x 1 film-coated tablet EU/1/06/343/007 90 x 1 film-coated tablet
Danish: Blisterpakning: EU/1/06/343/004 30 x 1 filmovertrukket tablet EU/1/06/343/007 90 x 1 filmovertrukket tablet
English: Baraclude 0.5 mg tablets entecavir
Danish: Baraclude 0,5 mg tabletter entecavir
English: Each ml of oral solution contains 0.05 mg entecavir.
Danish: Hver ml oral opløsning indeholder 0,05 mg entecavir.
English: What BARACLUDE is and what it is used for Baraclude tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus
Danish: Baraclude tabletter er anti-viral medicin, som anvendes til at behandle kronisk (vedvarende) infektion med hepatitis-B virus (HBV) hos voksne.
English: 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.
Danish: 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.
English: Baraclude 1 mg film-coated tablets entecavir
Danish: Baraclude 1 mg filmovertrukne tabletter entecavir
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: 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: Adefovir Dipivoxil 10 mg once daily n
Danish: Adefovirdipivo xil 10 mg en gang dagligt n
English: Each film-coated tablet contains 0.5 mg entecavir.
Danish: Hver filmovertrukket tablet indeholder 0,5 mg entecavir.
English: Each film-coated tablet contains 1 mg entecavir.
Danish: Hver filmovertrukket tablet indeholder 1 mg entecavir.
English: What BARACLUDE is and what it is used for Baraclude oral solution is an anti-viral medicine, used to treat chronic (long term) hepatitis B
Danish: Baraclude oral opløsning er anti-viral medicin, som anvendes til at behandle kronisk (vedvarende) infektion med hepatitis-B virus (HBV) hos voksne.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)c
Danish: Gennemsnitlig ændring fra baseline (log10 kopier/ml)c
English: Baraclude 1 mg film-coated tablets Tablet core:
Danish: Baraclude 1 mg filmovertrukne tabletter Tabletkerne:
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: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du vil have yderligere oplysninger om Baraclude, skal du henvende dig til den lokale repræsentant:
English: Baraclude 0.5 mg film-coated tablets entecavir
Danish: Baraclude 0,5 mg filmovertrukne tabletter entecavir
English: 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).
Danish: HBeAg-positive voksne patienter skal behandles mindst 12 måneder efter, de har opnået HBeserokonvertering (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 HBs-serokonvertering, eller indtil behandlingen ikke virker (se pkt.
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: White to off-white and triangular-shaped tablet with “BMS” debossed on one side and “1611” on the other.
Danish: Baraclude 0,5 mg filmovertrukne tabletter Hvid til grålighvid trekantet tablet med “BMS” mærket på den ene side og “1611” på den anden.
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: 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: What Baraclude is and what it is used for What you need to know before you take Baraclude How to take Baraclude
Danish: Det skal du vide, før du begynder at tage Baraclude Sådan skal du tage Baraclude Bivirkninger
English: Skin and subcutaneous tissue disorders: uncommon: rash, alopecia General disorders and administration site conditions:
Danish: ikke almindelig: udslæt, alopeci
English: do not stop taking Baraclude without your doctor's advice since your hepatitis may worsen after stopping treatment.
Danish: da din hepatitis kan forværres, efter at behandlingen stoppes.
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: Baraclude 0.5 mg film-coated tablets Tablet core:
Danish: Baraclude 0,5 mg filmovertrukne tabletter Tabletkerne:
English: Blisters: Do not store above 30°C.
Danish: Blistere: Må ikke opbevares ved temperaturer over 30°C.
English: Bottles: Do not store above 25°C.
Danish: Beholdere: Må ikke opbevares ved temperaturer over 25°C.
English: Maltitol: Baraclude oral solution contains maltitol.
Danish: Maltitol: Baraclude oral opløsning indeholder maltitol, og bør ikke anvendes til patienter med arvelig fructoseintolerans.
English: (HBV) infection in adults.
Danish: Det er muligt at blive vaccineret mod HBV.
English: if you have previously received treatment for chronic hepatits B, please inform your doctor.
Danish: Hvis du har taget for mange Baraclude tabletter skal du straks kontakte lægen.
English: Sodium citrate
Danish: Lactosemonohydrat
English: From Week 4 on (day 22-28):
Danish: Fra 4. uge (dag 22-28):
English: The volume of distribution is around 10 L/kg.
Danish: Distributionsvolumen er ca. 10 l/kg.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen, da den indeholder vigtige oplysninger.
English: You may experience increased symptoms as described in section 4 “Possible side effects”.
Danish: De kan opleve forøgede symptomer, som beskrevet i punkt 4 “Bivirkninger”.
English: • Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP) Ikke relevant
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan påvirke op til 1 ud af 10 personer):