FrancophonIA/ELRC3.0 huggingface dataset:
English: • Also tests may show decreases in phosphate (common) or increases in creatinine (very common) in the blood.
Danish: • Desuden kan test vise nedsat fosfatindhold (almindeligt) eller øget kreatininindhold (meget almindeligt) i blodet.
English: (may affect up to 1 in 100 people) • Damage to kidney tubule cells
Danish: (kan forekomme hos op til 1 ud af 100 personer) • Beskadigelse af de tubulære celler i nyrerne
English: Pharmacokinetic studies have not been conducted in the elderly.
Danish: Der er ikke foretaget farmakokinetiske studier hos ældre.
English: d. Paediatric population
Danish: d. Pædiatrisk population
English: There are only limited data on the safety and efficacy of this dosing interval adjustment guideline.
Danish: Der findes kun begrænsede data om sikkerheden og virkningen af disse retningslinjer for tilpasningen af dosisintervallet.
English: • If you do miss a dose of Hepsera, take it as soon as you can, and then take your next scheduled dose at its regular time.
Danish: • Hvis De glemmer en dosis Hepsera, så tag den så snart, De kommer i tanke om det, og tag derefter den næste dosis til sædvanlig tid.
English: The relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known.
Danish: Forholdet mellem behandlingsrespons og langsigtede udfald som f.eks. hepatocellulært carcinom eller dekompenseret cirrose er ikke kendt.
English: However, based on the safety profile and mechanism of action, adefovir dipivoxil is expected to have no or negligible influence on these abilities.
Danish: Det kan dog forventes, baseret på sikkerhedsprofilen og virkningsmekanismen, at adefovirdipivoxil ikke eller kun i ubetydelig grad har indflydelse på disse evner.
English: Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, flatulence
Danish: Diarré, opkastning, abdominalsmerter, dyspepsi, kvalme, flatulens
English: Nonetheless, there is a potential risk of selection of HIV strains resistant to adefovir with possible cross-resistance to other antiviral medicinal products.
Danish: Ikke desto mindre er der en potentiel risiko for at vælge hiv-stammer, som er resistente over for adefovir med mulig krydsresistens over for andre antivirale lægemidler.
English: The clinical significance of these observed changes in HBV DNA has not been established.
Danish: Den kliniske signifikans af disse observerede forandringer i HBV-dna er ikke fastlagt.
English: Gender, age and ethnicity: The pharmacokinetics of adefovir were similar in male and female patients.
Danish: Køn, alder og etnisk oprindelse: Adefovirs farmakokinetik var den samme hos mandlige og kvindelige patienter.
English: Your doctor will monitor you regularly while you take Hepsera.
Danish: Deres læge vil undersøge Dem jævnligt, mens De tager Hepsera.
English: Therefore, the standard recommended procedures for immunisation of infants should be followed to prevent neonatal acquisition of HBV.
Danish: Derfor bør de almindeligt anbefalede procedurer for immunisering af børn følges for at forebygge, at nyfødte bliver smittet med HBV.
English: In case of emergence of resistance, treatment should be modified.
Danish: Hvis der fremkommer resistens, bør behandlingen justeres.
English: Do not store above 30ºC.
Danish: Må ikke opbevares ved temperaturer over 30°C.
English: • It is especially important to tell your doctor if you are taking or have recently taken any of the following medicines which may damage your kidneys, or interact with Hepsera:
Danish: • Det er særlig vigtigt at fortælle det til lægen, hvis De tager eller for nylig har taget nogen af de følgende former for medicin, der kan skade nyrerne eller reagerer med Hepsera:
English: The tablets are marked with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Danish: Tabletterne er mærket med “GILEAD” og “10” på den ene side og en stiliseret form af en lever på den anden side.
English: Histological improvement was seen regardless of baseline demographic and hepatitis B characteristics, including prior interferon-alpha therapy.
Danish: Histologisk forbedring blev set, uanset baseline demografiske og hepatitis B karakteristika, herunder tidligere interferon-alfa terapi.
English: In these patients, including patients with decompensated liver disease, treatment cessation is not recommended and these patients should be monitored closely during therapy.
Danish: Hos disse patienter, samt hos patienter med dekompenseret leversygdom, anbefales behandlingsophør ikke, og disse patienter bør overvåges nøje under behandlingen.
English: It is recommended that mothers being treated with adefovir dipivoxil do not breast-feed their infants.
Danish: Det anbefales, at mødre, der behandles med adefovirdipivoxil, ikke ammer deres børn.
English: • Diarrhoea
Danish: • Diarré
English: • Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
Danish: • Fortæl det til lægen, hvis De har haft en nyresygdom, eller hvis test har vist, at De har problemer med nyrerne.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: You do not need to take another tablet if you are sick more than 1 hour after taking Hepsera.
Danish: De behøver ikke at tage en ekstra tablet, hvis de kaster op mere end 1 time efter, at De har taget Hepsera.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for adefovir, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for adefovir er CHMP nået frem til følgende videnskabelige konklusioner:
English: • Digestive problems including wind or discomfort after eating meals
Danish: • Fordøjelsesproblemer, herunder tarmluft eller ubehag efter måltiderne
English: Long-term safety data in patients with compensated disease:
Danish: Langvarige sikkerhedsdata hos patienter med kompenseret sygdom:
English: At concentrations substantially higher (> 4,000-fold) than those observed in vivo, adefovir did not inhibit any of the following human CYP450 isoforms, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
Danish: Ved koncentrationer, som er betydeligt højere (> 4.000 gange) end dem, som sås in vivo, hæmmede adefovir ikke nogen af følgende humane CYP450-isoformer: CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
English: Treatment with 10 mg adefovir dipivoxil has not been shown to be effective against HIV replication and therefore should not be used to control HIV infection.
Danish: Behandling med 10 mg adefovirdipivoxil har ikke vist sig at være effektiv mod hiv-replikation og bør derfor ikke anvendes til at behandle hiv-infektion.
English: In vitro binding of adefovir to human plasma or human serum proteins is ≤ 4 %, over the adefovir concentration range of 0.1 to 25 μg/ml.
Danish: In vitro binding af adefovir til humane plasma- eller serumproteiner er ≤ 4 %, over adefovir koncentrationsområdet på 0,1 til 25 μg/ml.
English: Very few patients developed adefovirassociated mutations up to 5 years; however, the number of patients who remained on drugs above week 96 was limited.
Danish: Meget få patienter udviklede adefovir-forbundne mutationer inden for 5 år; dog var antallet af patienter, der stadig fik lægemidlet efter uge 96, begrænset.
English: After 96, 144, 192 and 240 weeks of treatment with adefovir dipivoxil, resistance surveillance was performed for 293, 221, 116 and 64 patients, respectively.
Danish: Efter 96, 144, 192 og 240 ugers behandling med adefovirdipivoxil blev der foretaget resistensovervågning af henholdsvis 293, 221, 116 og 64 patienter.
English: Package leaflet: Information for the user Hepsera 10 mg tablets
Danish: Indlægsseddel: Information til brugeren Hepsera 10 mg tabletter
English: It is recommended to administer adefovir dipivoxil (one 10 mg tablet) every 48 hours in these patients.
Danish: Det anbefales at administrere adefovirdipivoxil (én 10 mg tablet) hver 48. time til disse patienter.
English: • vancomycin and aminoglycosides, used for bacterial infections
Danish: • vancomycin og aminoglykosider, der bruges mod bakterieinfektioner
English: Treatment cessation for chronic hepatitis B in these patients is not recommended.
Danish: Ophør med behandling for kronisk hepatitis B anbefales ikke hos disse patienter.
English: Do not store above 30ºC (86ºF).
Danish: Må ikke opbevares ved temperaturer over 30°C (86 °F).
English: The clinical significance of these findings as they relate to histological improvement is not known.
Danish: Den kliniske signifikans af disse fund i relation til histologisk forbedring er ikke kendt.
English: No clinically significant changes in renal function were observed.
Danish: Der blev ikke observeret nogen klinisk signifikante ændringer i nyrefunktionen.
English: Common:
Danish: Almindelige:
English: Paediatric population: Hepsera is not recommended for use in children below the age of 18 years due to limitations of the available data on safety and efficacy (see section 5.1).
Danish: Pædiatrisk population: Hepsera anbefales ikke til børn under 18 år på grund af begrænsninger i de tilgængelige data vedrørende sikkerhed og virkning (se pkt.
English: • Kidney problems may lead to softening of the bones (which causes bone pain and sometimes leads to fractures) and muscle pain or weakness.
Danish: • Nyreproblemer kan føre til bløde knogler (hvilket forårsager knoglesmerter og til tider knoglebrud) og muskelsmerter eller muskelsvaghed.
English: • Obligation to conduct post-authorisation measures
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: While the overall risk of renal impairment in patients with adequate renal function is low, this is of special importance in patients both at risk of or having underlying renal dysfunction, and also in patients receiving medicinal products that may affect renal function.
Danish: Mens den generelle risiko for nedsat nyrefunktion hos patienter med adækvat nyrefunktion er lav, er det af særlig betydning både for patienter, som har en risiko for eller har latent dysfunktion af nyrerne, og for patienter, der tager lægemidler, som kan påvirke nyrefunktionen.
English: The silica gel desiccant is contained in either a separate sachet or a small canister and should not be swallowed.
Danish: Silicagelen er enten i en separat pose eller i en lille beholder og må ikke sluges.
English: To differentiate between elevations in transaminases due to response to treatment and increases potentially related to lactic acidosis, physicians should ensure that changes in ALT are associated with improvements in other laboratory markers of chronic hepatitis B.
Danish: For at differentiere mellem stigninger i transaminaser på grund af respons på behandling og stigninger, som muligvis er relateret til lactacidosis, bør læger sikre sig, at ændringer i ALAT er forbundet med forbedringer i andre laboratoriemarkører af kronisk hepatitis B.
English: • Do not breast-feed while taking Hepsera.
Danish: • De må ikke amme, mens De tager Hepsera.
English: The role of adefovir and add-on lamivudine+adefovir in HBV therapy strategy should be regularly discussed in the light of emerging data.
Danish: Både adefovirs og add-on lamivudin+adefovirs rolle i HBV-behandlingsstrategien bør diskuteres regelmæssigt i lyset af de fremkomne data.
English: The demonstration of the benefit of adefovir dipivoxil is based on histological, virological, biochemical, and serological responses in adults with:
Danish: Påvisningen af den gavnlige effekt af adefovirdipivoxil er baseret på histologiske, virologiske, biokemiske og serologiske reaktioner hos voksne med:
English: These patients should be closely monitored for possible adverse reactions and to ensure efficacy is maintained.
Danish: Disse patienter bør overvåges nøje for mulige uønskede reaktioner og for at sikre, at virkningen opretholdes.
English: Hepsera contains lactose
Danish: Hepsera indeholder lactose
English: Due to their limitations, the clinical data available do not allow to draw definitive conclusions on the benefit/risk ratio of the adefovir treatment in children with chronic hepatitis B (see section 4.2).
Danish: På grund af deres begrænsninger tillader de tilgængelige kliniske data ikke, at der drages endelige konklusioner om fordele/risici ved adefovirbehandling hos børn med kronisk hepatitis B (se pkt.
English: Absorption: The oral bioavailability of adefovir from 10 mg adefovir dipivoxil is 59 %.
Danish: Absorption: Den orale biotilgængelighed af adefovir fra 10 mg adefovirdipivoxil er 59 %.
English: In a long-term safety study of 125 HBeAg negative patients with compensated liver disease, the adverse event profile was overall unchanged after a median exposure of 226 weeks.
Danish: I et langvarigt sikkerhedsstudie med 125 HBeAg-negative patienter med kompenseret leversygdom, var den overordnede profil af uønskede hændelser uændret efter en median eksponering på 226 uger.
English: Even though a pharmacokinetic interaction is unlikely given the two products are eliminated via different pathways, caution is recommended if both products are co-administered.
Danish: En farmakokinetisk interaktion ikke er sandsynlig, da de to lægemidler elimineres via forskellige veje, men alligevel anbefales det at være forsigtig, hvis begge lægemidler indgives samtidigt.
English: Improvement was defined as a reduction from baseline of two points or more in the Knodell necro-inflammatory score with no concurrent worsening in the Knodell fibrosis score.
Danish: Forbedring blev defineret som en reduktion fra baseline på mindst to eller flere points i Knodell's nekro-inflammatoriske score uden nogen samtidig forværring i Knodell's fibrosescore.
English: They are the same as some of the common side effects of Hepsera.
Danish: Disse symptomer er de samme som nogle af Hepseras almindelige bivirkninger.
English: Each bottle contains 30 tablets, silica gel desiccant and fibre packing material.
Danish: Hver flaske indeholder 30 tabletter, silicagel som tørremiddel og fiberpakningsmateriale.
English: • decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.
Danish: • dekompenseret leversygdom i kombination med et andet middel uden krydsresistens til Hepsera.
English: Method of administration Hepsera tablets should be taken once daily, orally with or without food.
Danish: Administration Hepsera-tabletter skal tages en gang dagligt, oralt med eller uden mad.
English: It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with adefovir dipivoxil and that renal function (creatinine clearance and serum phosphate) be monitored every four weeks during the first year and then every three months thereafter.
Danish: Det anbefales at beregne kreatininclearance for alle patienter, før behandlingen med adefovirdipivoxil påbegyndes, og at nyrefunktionen (kreatininclearance og serumphosphat) monitoreres hver 4. uge det første år og derefter hver 3. måned.
English: In patients with decompensated liver disease, adefovir should always be used in combination with a second agent, without cross-resistance to adefovir, to reduce the risk of resistance and to achieve rapid viral suppression.
Danish: Hos patienter med dekompenseret leversygdom bør adefovir altid anvendes i kombination med et andet middel uden krydsresistens til adefovir for at reducere risikoen for resistens og for at opnå hurtig viral suppression.
English: Median Cmax and AUC0-∞ values were 16.70 (9.66-30.56) ng/ml and 204.40 (109.75-356.05) ng·h/ml, respectively.
Danish: Mediane Cmax og AUC0-∞ værdier var hhv. 16,70 (9,66-30,56) ng/ml og 204,40 (109,75-356,05) ng·t/ml.
English: As far as possible, treatment of hepatitis B by adefovir dipivoxil in an HIV co-infected patient should be reserved for patients whose HIV RNA is controlled.
Danish: Så vidt muligt bør behandlingen af hepatitis B med adefovirdipivoxil hos en patient, som samtidig er inficeret med hiv, forbeholdes patienter, hvis hiv-rna er under kontrol.
English: Assessment of adverse reactions is based on experience from post-marketing surveillance and from three pivotal clinical studies in patients with chronic hepatitis B:
Danish: Vurderingen af bivirkninger er baseret på erfaring fra overvågningen efter markedsføring og fra tre pivotale kliniske studier hos patienter med kronisk hepatitis B:
English: Patients were all HBeAg positive and had median CD4 cell count of 441 cells/mm3 (no patient had CD4 count < 200 cells/mm3).
Danish: Patienterne var alle testet positive for HBeAg og havde et mediant CD4celletal på 441 celler/mm3 (ingen patienter havde CD4-celletal < 200 celler/mm3).
English: General: Patients should be advised that therapy with adefovir dipivoxil has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore appropriate precautions should still be taken.
Danish: Generelt: Patienterne skal informeres om, at det ikke er påvist, at behandling med adefovirdipivoxil reducerer risikoen for at smitte andre med hepatitis B-virus, og at der derfor fortsat skal tages hensigtsmæssige forholdsregler.
English: Some patients have had symptoms or blood tests indicating that their hepatitis has worsened after stopping treatment with Hepsera.
Danish: Nogle patienter har haft symptomer eller blodprøver, der tydede på, at deres leverbetændelse (hepatitis) var blevet forværret, efter at de var holdt op med Hepserabehandlingen.
English: No adverse effects on development were seen at systemic exposures approximately 12 times that achieved in humans at the therapeutic dose.
Danish: Ingen uønskede reaktioner på udviklingen blev set ved systemiske ekspositioner, der var ca. 12 gange den, der blev opnået hos mennesker med den terapeutiske dosis.
English: Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF08.
Danish: Farmakoterapeutisk klassifikation: Nukleosid- og nukleotidreverse-transkriptase-hæmmere, ATC-kode: J05AF08.
English: Caution should be exercised when prescribing nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease.
Danish: Der bør udvises forsigtighed, når der ordineres nukleosidanaloger til en patient (især overvægtige kvinder) med hepatomegali, hepatitis eller andre kendte risikofaktorer for leversygdom.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 tablets and outer cartons containing 90 (3 bottles of 30) tablets.
Danish: Følgende pakningsstørrelser findes: Ydre kartoner, der indeholder 1 boks med 30 tabletter, og ydre kartoner, der indeholder 90 (3 bokse med 30) tabletter.
English: Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1).
Danish: Påbegyndelse af behandling med Hepsera bør kun overvejes, når behandling med et alternativt antiviralt middel med en højere genetisk barriere mod resistensudvikling ikke er tilgængelig eller hensigtsmæssig (se pkt.
English: Infection with the hepatitis B virus leads to damage to the liver.
Danish: Infektion med hepatitis B-virus medfører leverskader.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
English: Talk to your doctor before using Hepsera.
Danish: Kontakt lægen, før De bruger Hepsera.
English: Benign digestive symptoms, such as nausea, vomiting and abdominal pain, might be indicative of lactic acidosis development.
Danish: Godartede fordøjelsessymptomer, som f.eks. kvalme, opkastning og abdominalsmerter, kan være tegn på udviklingen af lactacidosis.
English: No effects on male or female fertility, or reproductive performance, occurred in rats and there was no embryotoxicity or teratogenicity in rats or rabbits administered adefovir dipivoxil orally.
Danish: Ingen effekter på mandlig eller kvindelig fertilitet eller reproduktionsydelse opstod hos rotter, og der var ingen embryotoksicitet eller teratogenicitet hos rotter eller kaniner, som fik adefovirdipivoxil oralt.
English: The MAH shall complete, within the stated timeframe, the following measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Pregelatinised starch Croscarmellose sodium Lactose monohydrate Talc
Danish: Pregelatineret stivelse Croscarmellosenatrium Lactosemonohydrat Talcum
English: Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Danish: Derfor bør klinisk respons på både behandlingen og nyrefunktionen overvåges nøje hos disse patienter (se pkt.
English: Nervous system disorders: Common:
Danish: Nervesystemet: Almindelige:
English: Furthermore, for the few patients who remained on drug at week 240 (n=12) BMI Z score was lower than typical for their age and gender.
Danish: Herudover var BMI-Z-scoren for de få patienter, der fortsatte med at få lægemidlet ved uge 240 (n=12), lavere, end hvad der typisk observeres for deres alder og køn.
English: It's best for your doctor to monitor your health after stopping treatment with Hepsera.
Danish: Det er bedst, hvis Deres læge kontrollerer Deres helbred, når De er holdt op med Hepsera-behandlingen.
English: • lamivudine-resistant HBV with either compensated or decompensated liver disease, including patients pre- and post-liver transplantation or co-infected with HIV.
Danish: • lamivudin-resistent HBV med enten kompenseret eller dekompenseret leversygdom, herunder præ- og post-levertransplanterede patienter, eller patienter, der samtidig var inficeret med hiv.
English: • foscarnet, cidofovir or tenofovir disoproxil fumarate, for viral infections
Danish: • foscarnet, cidofovir eller tenofovirdisoproxilfumarat, der bruges mod virusinfektioner
English: The proposed dose interval modification is based on extrapolation of limited data in patients with end stage renal disease (ESRD) and may not be optimal.
Danish: Den anbefalede tilpasning af dosisintervallet er baseret på ekstrapolation af begrænsede data fra patienter med end-stage renal sygdom (End Stage Renal Disease, ESRD) og er eventuel ikke optimal.
English: • The recommended dose is one 10 mg tablet each day, taken with or without food.
Danish: • Den anbefalede dosis er en 10 mg tablet om dagen med eller uden mad.
English: If treatment cessation is necessary, patients should be closely monitored for several months after stopping treatment as exacerbations of hepatitis have occurred after discontinuation of 10 mg adefovir dipivoxil.
Danish: Hvis det er nødvendigt at ophøre med behandlingen, bør patienter overvåges nøje i flere måneder efter behandlingens ophør, da eksacerbationer af hepatitis er sket efter seponering af 10 mg adefovirdipivoxil.
English: The MAH commits to ensure continuous assessment of cross-resistance of adefovir to established and new nucleos(t)ide analogues, and provide reviews of these assessments as new data becomes available.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at sørge for fortsat vurdering af krydsresistens mellem adefovir og såvel kendte som nye nukleos(t)idanaloger og sørge for at gennemgå disse vurderinger, når nye data bliver tilgængelige.
English: If you forget to take Hepsera or you vomit
Danish: Hvis De har glemt at tage Hepsera eller kaster op
English: By the end of the study, 7 of 12 patients (58 %) with bridging fibrosis or cirrhosis at baseline, had an improved Ishak fibrosis score of ≥ 2 points.
Danish: Ved afslutningen af studiet havde 7 ud af 12 patienter (58 %) med brofibrose eller cirrose ved baseline en forbedret Ishak fibrosescore på ≥ 2 point.
English: Baseline Creatinine Clearance (ml/min)
Danish: Kreatininclearance ved baseline (ml/min)
English: Patients with advanced liver disease or cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation which may be fatal.
Danish: Patienter med fremskreden leversygdom eller cirrose kan være udsat for en højere risiko for leverdekompensation efter hepatitis-eksacerbation, hvilket kan være fatalt.