FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product must not be mixed with water, other solvents or other medicinal products.
Danish: Dette lægemiddel må ikke blandes med vand, andre solventer eller andre lægemidler.
English: Tell your doctor if you are pregnant or planning to become pregnant.
Danish: Fortæl det til lægen, hvis du er gravid eller hvis du planlægger at blive gravid.
English: Baraclude reduces the amount of virus in your body, and improves the condition of the liver.
Danish: Baraclude mindsker mængden af virus i kroppen og forbedrer leverens tilstand.
English: Baraclude will not control your HIV infection.
Danish: Baraclude vil ikke kontrollere din hiv-infektion.
English: Some patients must take Baraclude on an empty stomach (see Baraclude with food and drink in Section 2).
Danish: Nogle patienter skal tage Baraclude på tom mave (se Baraclude sammen med mad og drikke i afsnit 2).
English: At least 32.6 kgb
Danish: Mindst 32,6 kgb
English: Swallow the medicine directly from the measuring spoon.
Danish: Synk medicinen direkte fra måleskeen.
English: In most cases you may take Baraclude with or without food.
Danish: De fleste kan tage Baraclude med eller uden mad.
English: Children and adolescents (from 2 to less than 18 years of age) can take Baraclude with or without food.
Danish: Børn og unge (fra 2-18 år) kan tage Baraclude med eller uden mad.
English: The correct dose of Baraclude oral solution for children and adolescents is calculated by body weight and is taken once daily orally (by mouth) as shown below:
Danish: Den korrekte dosis af Baraclude oral opløsning til børn og unge beregnes ud fra kropsvægten og skal tages én gang dagligt oralt (igennem munden) som vist i det nedenstående:
English: The measuring spoon is manufactured by: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.
Danish: Måleskeen fremstilles af: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.
English: Do not use this medicine after the expiry date which is stated on bottle or carton after EXP. That expiry date refers to the last day of that month.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. ml, dvs. den er i det væsentlige natriumfri.
English: If it is almost time for your next dose, do not take the missed dose.
Danish: Hvis det næsten er tid til næste dosis, skal du ikke tage den glemte dosis.
English: If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach.
Danish: Hvis din leversygdom er meget fremskreden, vil lægen ligeledes vejlede dig i, at du skal tage Baraclude på tom mave.
English: Authorised Representative in the EEA for Comar Plastics: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany
Danish: Autoriseret repræsentant i EEA for Comar Plastics: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Tyskland.
English: Patients may be dosed with or without food.
Danish: Patienterne kan få dosis med eller uden mad.
English: Use the spoon as follows:
Danish: Brug skeen på følgende måde:
English: Your doctor will advise you on the dose that is right for you.
Danish: Lægen vil rådgive dig om, hvilken dosis der er bedst for dig.
English: It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.
Danish: Det er vigtigt, at frugtbare kvinder, som er i behandling med Baraclude, anvender effektiv svangerskabsforebyggelse for at forhindre graviditet.
English: Take Baraclude as long as your doctor has told you.
Danish: Tag Baraclude lige så længe som lægen har foreskrevet.
English: A lactose-free Baraclude oral solution is available for these individuals.
Danish: Der findes en lactosefri Baraclude oral opløsning til disse patienter.
English: PC: SN: <NN:>
Danish: <PC: SN:
English: This medicinal product contains maltitol.
Danish: Lægemidlet indeholder maltitol.
English: Baraclude tablets do not contain maltitol and can be taken by patients with fructose intolerance.
Danish: Baraclude tabletter indeholder ikke maltitol og kan anvendes til patienter med fructoseintolerans.
English: You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced.
Danish: Du bør ikke tage Baraclude for at behandle din hepatitis-B-infektion, medmindre du samtidig også tager medicin mod hiv, idet virkningen af fremtidig hiv-behandling kan blive nedsat.
English: Wait and take the next dose at the regular time.
Danish: Så må du vente og tage næste dosis til sædvanlig tid.
English: Do not dilute or mix this solution with water or anything else.
Danish: Opløsningen skal ikke fortyndes eller blandes med vand eller noget andet.
English: Dosing for nucleoside naive paediatric patients aged 2 to < 18 years
Danish: Dosis til nukleosid-naive pædiatriske patienter i alderen 2 til < 18 år
English: For children and adolescents (from 2 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight.
Danish: Til børn og unge (fra 2-18 år) vil dit barns læge fastsætte den korrekte dosis ud fra dit barns vægt.
English: Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Danish: Exacerbationer efter behandling er sædvanligvis forbundet med stigning i HBV-DNA, og størstedelen synes at være selvbegrænsende.
English: Baraclude should not be used during pregnancy unless clearly necessary.
Danish: Baraclude bør ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: Duration of therapy for paediatric patients The optimal duration of treatment is unknown.
Danish: Behandlingsvarighed hos pædiatriske patienter Den optimale behandlingsvarighed kendes ikke.
English: It is recommended that the dosing spoon be rinsed with water after each daily dose.
Danish: Det anbefales, at doseringsskeen dagligt renses med vand efter brug.
English: Name and address of the manufacturer responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italien
English: If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time.
Danish: Hvis du glemmer at tage en dosis af Baraclude, skal du tage den så hurtigt som muligt, og herefter tage næste dosis til sædvanlig tid.
English: Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Danish: Baraclude tilhører en gruppe medicin, der kan forårsage lactacidose (ophobning af mælkesyre i blodet) og forstørret lever.
English: Titanium dioxide Hypromellose Macrogol 400
Danish: Titandioxid Hypromellose Macrogol 400
English: Baraclude with food and drink
Danish: Baraclude sammen med mad og drikke
English: (HBV) through sexual contact or body fluids (including blood contamination).
Danish: gennem seksuel kontakt eller kropsvæsker (fx blod).
English: Baraclude can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Danish: Baraclude kan anvendes til børn, hvis lever er skadet, men stadig fungerer ordentligt (kompenseret leversygdom).
English: Results for the main efficacy endpoints at Week 48 and Week 96 are presented in the table below.
Danish: Resultaterne for de vigtigste endepunkter ved uge 48 og uge 96 er vist i nedenstående tabel.
English: At least 32.6 kg
Danish: Mindst 32,6 kg
English: The oral solution should be used for patients with body weight less than 32.6 kg.
Danish: Den orale opløsning bør anvendes til patienter med en kropsvægt under 32,6 kg
English: The recommended once-daily dose in paediatric patients weighing at least 10 kg, is presented in the table below.
Danish: Den anbefalede dosis en gang dagligt til pædiatriske patienter, der vejer mindst 10 kg, er vist i nedenstående tabel.
English: Also contains: maltitol, preservatives E216, E218.
Danish: Indeholder også: maltitol, konserveringsmidler E216, E218
English: Baraclude can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Danish: Baraclude kan anvendes til mennesker, hvis lever er skadet, men stadig fungerer ordentligt (kompenseret leversygdom) og til mennesker, hvis lever er skadet og ikke fungerer ordentligt (inkompenseret leversygdom).
English: Baraclude contains lactose
Danish: Baraclude indeholder lactose
English: A reduction of the daily dose using Baraclude oral solution, as detailed in the table, is recommended.
Danish: Det anbefales at reducere daglig dosis af Baraclude oral opløsning, som angivet i tabellen.
English: After each use, rinse the spoon with water and allow it to air dry.
Danish: Efter brug renses skeen med vand og lufttørres.
English: Sodium: Each ml of this medicinal product contains 0.015 mmol (or 0.3 mg) sodium.
Danish: Natrium: hver ml af dette lægemiddel indeholder 0,015 mmol (eller 0,3 mg) natrium.
English: Breast-feeding should be discontinued during treatment with Baraclude.
Danish: Amning bør afbrydes under behandling med Baraclude.
English: discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Baraclude treatment may be.
Danish: tal med din læge om din lever fungerer ordentligt, og hvis ikke, find ud af, hvordan det kan påvirke din behandling med Baraclude.
English: General: patients should be advised that therapy with entecavir has not been proven to reduce the risk of transmission of HBV and therefore appropriate precautions should still be taken.
Danish: Generelt: Patienterne skal informeres om, at det ikke er påvist at behandling med entecavir mindsker risikoen for overførsel af HBV, og at der derfor fortsat skal tages relevante forholdsregler.
English: What you need to know before you take BARACLUDE Do not take Baraclude if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage BARACLUDE Tag ikke Baraclude hvis du er overfølsom (allergisk) over for entecavir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: 210 ml oral solution in a HDPE bottles with child-resistant closures (polypropylene).
Danish: 210 ml oral opløsning i HDPE-flaske med børnesikret låg (polypropylen).
English: Lactose: this medicinal product contains 120.5 mg of lactose in each 0.5 mg daily dose or 241 mg of lactose in each 1 mg daily dose.
Danish: Lactose: Dette lægemiddel indeholder 120,5 mg lactose ved en daglig dosis på 0,5 mg og 241 mg lactose ved en daglig dosis på 1 mg.
English: * for doses < 0.5 mg Baraclude oral solution is recommended.
Danish: * ved doser < 0,5 mg Baraclude anbefales oral opløsning.
English: Also contains lactose monohydrate.
Danish: Indeholder også lactosemonohydrat.
English: Talk to your doctor or pharmacist before taking Baraclude if you have ever had problems with your kidneys, tell your doctor.
Danish: Kontakt lægen eller apoteket, før du tager Baraclude hvis du tidligere har haft problemer med nyrerne, skal du fortælle din læge det.
English: For children and adolescents (from 2 to less than 18 years of age), Baraclude oral solution or Baraclude 0.5 mg tablets are available
Danish: Til børn og unge (fra 2-18 år), findes Baraclude oral opløsning eller Baraclude 0,5 mg tabletter
English: HBV DNA < 50 IU/mLa
Danish: HBV-DNA < 50 IE/mla
English: It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk.
Danish: Det vides ikke om entecavir, der er det aktive indholdsstof i Baraclude, udskilles i mælken.
English: High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets.
Danish: HDPE-beholder (high-density polyethylene) med børnesikret, polypropylen-lukning der indeholder 30 filmovertrukne tabletter.
English: Holding the spoon with the volume marks facing you, check that it has been filled to the proper mark.
Danish: Hold skeen, så du kan se målemærkerne og check, at skeen er fyldt til det rigtige mærke.
English: Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
Danish: Det er vigtigt, fordi Baraclude udskilles gennem nyrerne, og din dosis eller dosisintervallet skal tilpasses.
English: HBV DNA < 50 IU/mL and HBeAg seroconversiona HBV DNA < 50 IU/mLa HBeAg seroconversiona ALT normalizationa
Danish: HBV-DNA < 50 IE/ml og HBeAg-serokonverteringa HBV-DNA < 50 IE/mla HBeAg-serokonverteringa ALAT-normaliseringa
English: Hold the spoon in a vertical (upright) position and fill it gradually to the mark corresponding to the prescribed dose.
Danish: Hold skeen lodret og fyld den langsomt til det mærke, der svarer til den dosis, lægen har ordineret.
English: OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT
Danish: TEKST PÅ YDRE KARTON (BEHOLDER OG BLISTERPAKNINGER) OG TEKST PÅ BEHOLDERENS ETIKET
English: Other medicines and Baraclude
Danish: Brug af anden medicin sammen med Baraclude
English: The oral solution is a clear, colorless to pale yellow solution.
Danish: Den orale opløsning er en klar, farveløs til svagt gul opløsning.
English: If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily.
Danish: Hvis du tidligere har fået medicin, der indeholder lamivudin, skal du dog være opmærksom på følgende: Hvis du er skiftet til Baraclude, fordi behandlingen med lamivudin ikke virkede, skal du tage Baraclude på tom mave, én gang dagligt.
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a Year 4 a
Danish: Opståen af entecavir genotype-resistens til og med År 5, lamivudin-refraktære forsøg År 1 År 2 År 3a
English: If your doctor instructs you to take Baraclude on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Danish: Hvis lægen har sagt, at du skal tage Baraclude på tom mave, betyder det mindst 2 timer efter et måltid og mindst 2 timer før næste måltid.
English: It has not been demonstrated that Baraclude is safe to use during pregnancy.
Danish: Det vides ikke, om det er sikkert at bruge Baraclude under graviditet.
English: OUTER CARTON AND BOTTLE LABEL TEXT
Danish: YDRE KARTON OG TEKST PÅ FLASKENS ETIKET
English: Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone.
Danish: Tabletkerne: crospovidon, lactosemonohydrat, magnesiumstearat, cellulose, mikrokrystallinsk og povidon.
English: The film-coated tablets (tablets) are pink and triangular-shaped.
Danish: De filmovertrukne tabletter er lyserøde og trekantede.
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: til < 1/10); ikke almindelig (≥ 1/1.000 til <1/100); sjælden (≥ 1/10.000 til <1/1.000).
English: Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution.
Danish: Baraclude 0,05 mg/ml oral opløsning leveres i en beholder med 210 ml oral opløsning.
English: Patients treated with Baraclude have reported the following side effects: common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
Danish: Patienter behandlet med Baraclude har indberettet følgende bivirkninger: almindelige (forekommer hos mellem 1 og 10 ud af 100 patienter): hovedpine, søvnløshed, voldsom træthed, svimmelhed, søvnighed, opkastning, diarré, kvalme, fordøjelsesbesvær og forhøjet indhold af leverenzymer i blodet.
English: common: headache, dizziness, somnolence
Danish: almindelig: hovedpine, svimmelhed, søvnighed
English: Each 1 mg film-coated tablet contains 241 mg lactose.
Danish: Hver 1 mg tablet indeholder 241 mg lactose.
English: Recommended Once Daily Dose of Oral Solution
Danish: Anbefalet dosis af oral opløsning én gang dagligt
English: Blister pack: 30 x 1 film-coated tablet 90 x 1 film-coated tablet
Danish: Blisterpakning: 30 x 1 filmovertrukket tablet 90 x 1 filmovertrukket tablet
English: Contents of the pack and other information What Baraclude contains
Danish: Pakningsstørrelser og yderligere oplysninger Baraclude indeholder:
English: Baraclude is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to < 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Danish: Baraclude er også indiceret til behandling af kronisk HBV-infektion hos nukleosid-naive pædiatriske patienter fra 2 til < 18 år med kompenseret leversygdom, som har tegn på aktiv virusreplikation og vedvarende forhøjet serum-ALAT eller histologisk påvist moderat til svær inflammation og/eller fibrose.
English: Baraclude 1 mg film-coated tablets Pink and triangular-shaped tablet with “BMS” debossed on one side and “1612” on the other.
Danish: Baraclude 1 mg filmovertrukne tabletter Lyserød trekantet tablet med “BMS” mærket på den ene side og “1612” på den anden.
English: You should not breast-feed during treatment with Baraclude.
Danish: Du må ikke amme, mens du er i behandling med Baraclude.
English: Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).
Danish: Tabletovertræk: hypromellose, macrogol 400, titandioxid (E171) og polysorbat 80 (E433).
English: They are marked with “BMS” on one side and “1612” on the other.
Danish: De er mærkede “BMS” på den ene side og “1612” på den anden.
English: common: insomnia
Danish: almindelig: søvnløshed
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBVinfected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV.
Danish: Sikkerhed og virkning af entecavir blev også undersøgt i et aktivt kontrolleret klinisk forsøg med 191 HBVinficerede patienter med inkompenseret leversygdom og i et klinisk forsøg med 68 patienter, der var co-inficerede med HBV og hiv.
English: Do not stop Baraclude without your doctor's advice
Danish: Du må ikke holde op med at tage Baraclude uden at have talt med lægen
English: Parahydroxybenzoates: Baraclude oral solution contains the preservatives methylhydroxybenzoate and propylhydroxybenzoate, that may cause allergic reactions (possibly delayed).
Danish: Parahydroxybenzoater: Baraclude oral opløsning indeholder konserveringsmidlerne methylparahydroxybenzoat og propylparahydroxybenzoat, som kan forårsage allergiske reaktioner (muligvis forsinkede).
English: Resistance and specific precaution for lamivudine-refractory patients: mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).
Danish: Resistens og specifikke forsigtighedsregler for lamivudinrefraktære patienter: Mutationer i den HBVpolymerase, der koder for lamivudinresistenssubstitutioner, kan forårsage sekundære substitutioner, inklusive entecavir-associerede resistenssubstitutioner (ETVr).
English: Baraclude must not be used during pregnancy unless specifically directed by your doctor.
Danish: Baraclude må ikke anvendes under graviditet undtagen, hvis lægen har ordineret det til dig.
English: They are marked with “BMS” on one side and “1611” on the other.
Danish: De er mærkede “BMS” på den ene side og “1611” på den anden.
English: For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
Danish: For både kompenseret and inkompenseret leversygdom er denne indikation baseret på data fra kliniske forsøg hos nukleosid-naive patienter med HBeAg-positiv og HBeAg-negativ HBV-infektion.
English: Clinical experience: the demonstration of benefit is based on histological, virological, biochemical, and serological responses after 48 weeks of treatment in active-controlled clinical trials of 1,633 adults with chronic hepatitis B infection, evidence of viral replication and compensated liver disease.
Danish: Klinisk erfaring: Påvisning af benefit er baseret på histologiske, virologiske, biokemiske og serologiske respons efter 48 ugers behandling i aktivt kontrollerede kliniske forsøg med 1.633 voksne med kronisk hepatitis B-infektion, dokumenteret virusreplikation og kompenseret leversygdom.
English: Outer carton: Baraclude 1 mg
Danish: Ydre karton: Baraclude 1 mg
English: 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.
Danish: På tidspunktet for langtidsbiopsien havde alle patienter HBV-DNA < 300 kopier/ml, og 49/57 (86%) havde serum ALAT ≤ 1 gange ULN.
English: b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58 (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: How to take BARACLUDE Not all patients need to take the same dose of Baraclude.
Danish: Sådan skal du tage BARACLUDE Dosis af Baraclude er ikke den samme til alle patienter.
English: Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Orange flavour (acacia and natural flavours) Sodium hydroxide to adjust pH to approximately 6 Hydrochloric acid to adjust pH to approximately 6 Purified water
Danish: Methylhydroxybenzoat (E218) Propylhydroxybenzoat (E216) Appelsinsmag (akacie- og naturlige smagsstoffer) Natriumhydroxid til justering af pH til ca. 6 Saltsyre til justering af pH til ca. 6
English: Oral solution Clear, colourless to pale yellow solution
Danish: Oral opløsning Klar, farveløs til svagt gul opløsning.
English: Baraclude tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Danish: Baraclude tabletter anvendes også til at behandle kronisk (vedvarende) infektion med HBV hos børn og unge i alderen 2-18 år.
English: Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide red.
Danish: Tabletovertræk: hypromellose, macrogol 400, titandioxid (E171) og rød jernoxid.
English: Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine-resistance.
Danish: Patienter med lamivudin-resistent HBV har højere risiko for efterfølgende at udvikle entecavir-resistens end patienter, der ikke er lamivudin-refraktære.