FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral administration of Vemlidy under fasted conditions in adult patients with chronic hepatitis B, peak plasma concentrations of tenofovir alafenamide were observed approximately 0.48 hours post-dose.
Danish: Efter oral administration af Vemlidy til voksne fastende patienter med kronisk hepatitis B blev de højeste plasmakoncentrationer af tenofoviralafenamid observeret cirka 0,48 timer efter dosering.
English: Tenofovir alafenamide This medicine is subject to additional monitoring.
Danish: Tenofovir-alafenamid Dette lægemiddel er underlagt supplerende overvågning.
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.
Danish: Behandlingen bør påbegyndes af en læge med erfaring i behandling af patienter med kronisk hepatitis B.
English: Stopping treatment with Vemlidy may cause your hepatitis B to get worse.
Danish: Hvis du holder op med at tage Vemlidy, kan din hepatitis B blive værre.
English: No clinically relevant differences in pharmacokinetics according to age or ethnicity have been identified.
Danish: Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle i henhold til alder eller etnisk baggrund.
English: There are no safety data on the use of Vemlidy to treat HBV infected patients with CrCl < 30 mL/min.
Danish: Der foreligger ingen sikkerhedsdata fra anvendelse af Vemlidy til behandling af HBV-inficerede patienter med CrCl < 30 ml/min.
English: A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Danish: En mulig risiko for nefrotoksicitet som følge af kronisk eksponering for lave niveauer af tenofovir fra doseringen med tenofoviralafenamid kan ikke udelukkes (se pkt.
English: Yellow, round, film-coated tablets, 8 mm in diameter, debossed with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Danish: Gule, runde, filmovertrukne tabletter, der måler 8 mm i diameter, præget med „GSI“ på tablettens ene side og „25“ på den anden.
English: There are no data on the safety and efficacy of Vemlidy in HBV infected patients with decompensated liver disease and who have a Child Pugh Turcotte (CPT) score > 9 (i.e. class C).
Danish: Der foreligger ingen data om Vemlidys sikkerhed og virkning hos HBV-inficerede patienter med dekompenseret leversygdom, som har en Child Pugh Turcotte-score (CPT) > 9 (dvs. klasse C).
English: Patients co-infected with HBV and hepatitis C or D virus
Danish: Patienter, der er inficeret med både HBV og hepatitis C- eller D-virus
English: Vemlidy comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Danish: Vemlidy findes i beholdere med 30 tabletter (med kiselgel som tørremiddel; dette skal opbevares i beholderen for at beskytte tabletterne).
English: Because there is a lower tenofovir exposure in rats and mice after tenofovir alafenamide administration compared to tenofovir disoproxil fumarate, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil fumarate.
Danish: Da der er en lavere eksponering for tenofovir hos rotter og mus efter administration af tenofoviralafenamid sammenlignet med tenofovirdisoproxilfumarat, blev der kun udført karcinogenicitetsstudier og et peri-postnatalt studie med rotter med tenofovirdisoproxilfumarat.
English: No special hazard for humans was revealed in conventional studies of carcinogenic potential with tenofovir disoproxil (as fumarate) and toxicity to reproduction and development with tenofovir disoproxil (as fumarate) or tenofovir alafenamide.
Danish: Der blev ikke vist nogen særlig risiko for mennesker i konventionelle studier af karcinogent potentiale med tenofovirdisoproxil (som fumarat) og toksicitet for reproduktion og udvikling med tenofovirdisoprocil (som fumarat) eller tenofoviralafenamid.
English: Package leaflet: Information for the patient Vemlidy 25 mg film-coated tablets
Danish: Indlægsseddel: Information til patienten Vemlidy 25 mg filmovertrukne tabletter
English: Effects on drug levels.a,b Mean ratio (90% confidence interval) for AUC, Cmax, Cmin
Danish: Virkning på lægemiddelkoncentrationer.a,b Middelratio (90 % konfidensinterval) for AUC,
English: Vemlidy does not reduce the risk of passing on hepatitis B to others through sexual contact or blood contamination.
Danish: Vemlidy nedsætter ikke din risiko for at smitte andre med hepatitis B gennem seksuel kontakt eller blod.
English: Acute exacerbation of hepatitis has been reported in patients who have discontinued treatment for hepatitis B, usually in association with rising HBV DNA levels in plasma.
Danish: Akut hepatitis-eksacerbation er rapporteret hos patienter, efter de er ophørt med behandling af hepatitis B, som regel i tilknytning til en stigning i plasma-HBV-DNA.
English: Assessment of adverse reactions is based on pooled safety data from 2 controlled Phase 3 studies in which 866 HBV infected patients received tenofovir alafenamide 25 mg once daily in a double-blind fashion through Week 96 (median duration of blinded study drug exposure of 104 weeks) and from post-marketing experience.
Danish: Vurderingen af bivirkninger er baseret på samlede sikkerhedsdata fra 2 kontrollerede fase 3-studier, hvor 866 HBV-inficerede patienter fik 25 mg tenofoviralafenamid en gang dagligt på en dobbeltblindet måde til og med uge 96 (median eksponeringsvarighed på 104 uger for blindet studielægemiddel) samt på erfaringer efter markedsføring.
English: Steady state Cmax for tenofovir alafenamide and tenofovir were 0.18 and 0.02 µg/mL, respectively.
Danish: Steady state-Cmax for tenofoviralafenamid og tenofovir var henholdsvis 0,18 og 0,02 µg/ml.
English: However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Danish: Tenofovirdisoproxilfumarat reducerede imidlertid afkommets levedygtighed og vægt i et peripostnatalt toksicitetsstudie ved doser, der var toksiske for moderen.
English: Co-administration is not recommended.
Danish: Samtidig administration frarådes.
English: In a pooled analysis of patients receiving Vemlidy, sequence analysis was performed on paired baseline and on-treatment HBV isolates for patients who either experienced virologic breakthrough (2 consecutive visits with HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or 1.0 log10 or greater increase in HBV DNA from nadir) or patients with HBV DNA ≥ 69 IU/mL at Week 96 or at early discontinuation at or after Week 24.
Danish: I en samlet analyse af patienter, som fik Vemlidy, blev der udført sekvensanalyse med parrede isolater af HBV ved baseline og efter behandling hos patienter, der enten oplevede virologisk gennembrud (2 konsekutive besøg med HBV-DNA ≥ 69 IE/ml efter at have været < 69 IE/ml, eller 1,0 log10 eller højere stigning i HBV-DNA fra nadir) eller patienter med HBV-DNA ≥ 69 IE/ml i uge 96 eller ved tidlig seponering ved eller efter uge 24.
English: Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of mitochondrial toxicity in vitro based on several assays including mitochondrial DNA analyses.
Danish: Tenofovirdiphosphat er en svag hæmmer af DNA-polymerase hos pattedyr, herunder mitokondriel DNA-polymerase γ, og der er ingen evidens for mitokondriel toksicitet in vitro på baggrund af adskillige assays, herunder analyse af mitokondrielt DNA.
English: The use of Vemlidy may be considered during pregnancy, if necessary.
Danish: Hvis det er indiceret, kan anvendelse af Vemlidy overvejes under graviditet.
English: Vemlidy film-coated tablets are yellow, round, printed (or marked) with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Danish: Vemlidy er gule, runde, filmovertrukne tabletter, som har „GSI“ trykt (eller præget) på den ene side af tabletten og „25“ på den anden side.
English: Nucleoside-naïveb Nucleoside-experienced ALT
Danish: Nukleosid-naivb Nukleosid-erfaren ALAT
English: Vemlidy may interact with other medicines.
Danish: Vemlidy kan påvirke andre lægemidler.
English: These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions.
Danish: Disse patienter kan have en større risiko for at få alvorlige bivirkninger relateret til lever eller nyrer.
English: The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and/or OATP1B3.
Danish: Fordelingen af tenofoviralafenamid i kroppen kan blive påvirket af aktiviteten af OATP1B1 og/eller OATP1B3.
English: • anticonvulsants used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital or phenytoin
Danish: • krampestillende midler, der anvendes til behandling af epilepsi, såsom: carbamazepin, oxcarbazepin, phenobarbital eller phenytoin
English: In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by carboxylesterase-1 in hepatocytes; and by cathepsin A in peripheral blood mononuclear cells (PBMCs) and macrophages.
Danish: In vitro-studier har vist, at tenofoviralafenamid metaboliseres til tenofovir (primær metabolit) af carboxylesterase-1 i hepatocytter og af cathepsin A i mononukleære celler fra perifert blod (PBMC'er) og i makrofager.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vemlidy in one or more subsets of the paediatric population in the treatment of chronic hepatitis B (see sections 4.2 and 5.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Vemlidy i en eller flere undergrupper af den pædiatriske population ved behandling af kronisk hepatitis B (se pkt.
English: The following adverse drug reactions have been identified with tenofovir alafenamide in patients with chronic hepatitis B (Table 2).
Danish: Nedenstående bivirkninger er blevet identificeret med tenofoviralafenamid hos patienter med kronisk hepatitis B (tabel 2).
English: It is not known whether tenofovir can be removed by peritoneal dialysis.
Danish: Det er ukendt, om tenofovir kan fjernes ved peritonealdialyse.
English: • In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy.
Danish: • Behandling af HBeAg-negative patienter uden cirrose bør som minimum fortsætte indtil HBsserokonversion, eller indtil der er evidens for tab af virkning.
English: Contents of the pack and other information What Vemlidy contains
Danish: Pakningsstørrelser og yderligere oplysninger Vemlidy indeholder:
English: How to take Vemlidy Always take this medicine exactly as your doctor has told you.
Danish: Sådan skal du tage Vemlidy Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: No dose adjustment of Vemlidy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 15 mL/min or in patients with CrCl < 15 mL/min who are receiving haemodialysis.
Danish: Dosisjustering af Vemlidy er ikke nødvendig hos voksne eller unge (på mindst 12 år og med en legemsvægt på mindst 35 kg) med en estimeret kreatininclearance (CrCl) ≥ 15 ml/min eller hos patienter med CrCl < 15 ml/min, som er i hæmodialyse.
English: Other medicines and Vemlidy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Vemlidy Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or until there is loss of efficacy (see section 4.4).
Danish: • Behandling af HBeAg-positive patienter uden cirrose bør fortsætte i mindst 6-12 måneder efter bekræftelse af HBe-serokonversion (tab af HBeAg og tab af HBV-DNA med påvisning af anti-HBe) eller indtil HBs-serokonversion eller indtil tab af virkning (se pkt.
English: No additional adverse reactions to Vemlidy were identified from Week 96 through Week 120 in the double-blind phase and in the subset of subjects receiving open-label Vemlidy treatment (see section 5.1).
Danish: Ingen yderligere bivirkninger for Vemlidy blev identificeret fra uge 96 til og med uge 120 i den dobbeltblindede fase og i undergruppen af patienter, der fik ikke-blindet behandling med Vemlidy (se pkt.
English: 1.8% (95% CI = -3.6% to 7.2%)
Danish: 1,8 % (95 % CI = -3,6 % til 7,2 %) -3,6 % (95 % CI = -9,8 % til 2,6 %)
English: Drug interaction information for Vemlidy with potential concomitant medicinal products is summarised in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”; twice daily as “b.i.d.”, single dose as “s.d.”, once daily as “q.d.”; and intravenously as “IV”).
Danish: Oplysninger om lægemiddelinteraktion mellem Vemlidy og potentielle samtidige lægemidler ses i tabel 1 nedenfor (stigning er angivet som „↑“, fald som „↓“, ingen ændring som „↔“; intravenøst er angivet som „i.v.“).
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Kiselgelen ligger i en pose eller beholder og må ikke sluges.
English: Based on Phase 3 population pharmacokinetic analysis in subjects with chronic hepatitis B, mean steady state AUC0-24 for tenofovir alafenamide (N = 698) and tenofovir (N = 856) were 0.22 µg•h/mL and 0.32 µg•h/mL, respectively.
Danish: Baseret på en fase 3-populationsfarmakokinetisk analyse hos studiedeltagere med kronisk hepatitis B var det gennemsnitlige steady state-AUC0-24 for tenofoviralafenamid (N = 698) og tenofovir (N = 856) henholdsvis 0,22 µg•time/ml og 0,32 µg•time/ml.
English: No dose adjustment of midazolam (administered orally or IV) is required.
Danish: Dosisjustering af midazolam (administreret oralt eller intravenøst) er ikke nødvendig.
English: d Includes patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy, e.g.
Danish: d. Omfatter patienter, som seponerede lægemidlet af andre årsager end bivirkninger (AE), død eller manglende eller tab af virkning, dvs. patienter, som trak deres samtykke tilbage, patienter, der ikke kunne følges op på osv.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of tenofovir alafenamide.
Danish: En minimal infiltration af histiocytter i øjet blev observeret hos hunde ved eksponeringer for tenofoviralafenamid og tenofovir, der var henholdsvis ca. 4 og 17 gange højere, end hvad der forventes efter administration af tenofoviralafenamid.
English: Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Danish: Tenofoviralafenamid hæmmer ikke human uridindifosfatglukuronosyltransferase (UGT) 1A1 in vitro.
English: • antifungal medicines used to treat fungal infections, containing: ketoconazole or itraconazole
Danish: • antimykotika, der anvendes til behandling af svampeinfektioner, og som indeholder: ketoconazol eller itraconazol.
English: The safety and efficacy of Vemlidy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Danish: Vemlidys sikkerhed og virkning hos børn under 12 år eller med en legemsvægt < 35 kg er endnu ikke klarlagt.
English: Tenofovir is renally eliminated from the body by the kidneys by both glomerular filtration and active tubular secretion.
Danish: Tenofovir elimineres renalt, både ved glomerulær filtration og aktiv tubulær sekretion.
English: If more than 18 hours have passed from the time it is usually taken, the patient should not take the missed dose and should simply resume the normal dosing schedule.
Danish: Hvis der er gået mere end 18 timer, skal patienten ikke tage den glemte dosis, men blot fortsætte med den normale doseringsplan.
English: In patients who remained on blinded treatment beyond Week 96, mean percentage change in BMD in each group at Week 120 was similar to that at Week 96.
Danish: Hos patienter, som forblev på blindet behandling efter uge 96, var den gennemsnitlige procentvise ændring i BMD i hver gruppe i uge 120 lig med den i uge 96.
English: Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination.
Danish: Tenofovirdiphosphat hæmmer HBV-replikation ved at blive inkorporeret i viralt DNA ved hjælp af HBV-revers transkriptase, hvilket resulterer i DNA-kædeterminering.
English: In patients who remained on blinded treatment beyond Week 96 in Studies 108 and 110, changes from baseline in renal laboratory parameter values in each group at Week 120 were similar to those at Week 96.
Danish: Hos patienter, som forblev på blindet behandling efter uge 96 i studie 108 og 110, var ændringen fra baseline i renale laboratorieparameterværdier hos hver gruppe i uge 120 lig med dem i uge 96.
English: • If it is less than 18 hours after you usually take Vemlidy, take it as soon as you can, and then take your next dose at its regular time.
Danish: • Hvis der er gået mindre end 18 timer siden det tidspunkt, hvor du normalt tager Vemlidy, skal du tage lægemidlet snarest muligt og derefter tage den næste dosis til sædvanlig tid.
English: No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between adolescent and adult HIV-1 infected subjects.
Danish: Der blev ikke set nogen klinisk relevante forskelle i tenofoviralafenamids eller tenofovirs farmakokinetik mellem unge og voksne hiv 1-inficerede patienter.
English: Bone toxicity was observed as reduced BMD in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of tenofovir alafenamide.
Danish: Der blev observeret knogletoksicitet i form af reduceret BMD hos rotter og hunde ved tenofovir-eksponeringer, der var mindst fire gange højere end dem, der forventes efter administration af tenofoviralafenamid.
English: Vemlidy contains the active substance tenofovir alafenamide.
Danish: Vemlidy indeholder det aktive stof tenofovir-alafenamid.
English: Co-administration with other medicinal products
Danish: Samtidig administration af andre lægemidler
English: • If it is more than 18 hours after you usually take Vemlidy, then do not take the missed dose.
Danish: • Hvis der er gået mere end 18 timer siden det tidspunkt, hvor du normalt tager Vemlidy, skal du ikke tage den glemte dosis.
English: • Tell your doctor if you have a history of liver disease.
Danish: • Fortæl det til lægen, hvis du nogensinde har haft en leversygdom.
English: Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Danish: Tenofoviralafenamid er et fosfonamidat-prodrug af tenofovir (2'-deoxyadenosinmonophosphatanalog).
English: ORAL CONTRACEPTIVES Norgestimate (0.180 mg/0.215 mg/ 0.250 mg orally, q.d.)
Danish: ORALE KONTRACEPTIVA Norgestimat (0,180 mg/0,215 mg/0,250 mg oralt, en gang dagligt)
English: If you stop taking Vemlidy Do not stop taking Vemlidy without your doctor's advice.
Danish: Hvis du holder op med at tage Vemlidy Du må ikke holde op med at tage Vemlidy uden først at drøfte det med lægen.
English: This is an antiviral medicine, known as a nucleotide reverse transcriptase inhibitor (NtRTI).
Danish: Det er et lægemiddel mod virus (et antiviralt lægemiddel) og kaldes en nukleotid revers transkriptasehæmmer (NtRTI).
English: Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Danish: Intracellulært tenofovir fosforyleres efterfølgende til den farmakologisk aktive metabolit tenofovirdiphosphat.
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Danish: Hos patienter med fremskreden leversygdom eller cirrose frarådes behandlingsophør, eftersom forværring af hepatitis efter behandlingsophør kan medføre hepatisk dekompensation.
English: Skin and subcutaneous tissue disorders Common
Danish: Forhøjet ALAT Hud og subkutane væv Almindelig
English: Each bottle contains silica gel desiccant and polyester coil.
Danish: Hver beholder indeholder kiselgel-tørremiddel og en polyesterspiral.
English: Table 3: HBV DNA efficacy parameters at Week 48a
Danish: Tabel 3: Parametre for virkning på HBV-DNA i uge 48a
English: HIV antibody testing should be offered to all HBV infected patients whose HIV-1 infection status is unknown before initiating therapy with Vemlidy.
Danish: Før behandling med Vemlidy iværksættes, skal alle HBV-inficerede patienter, hvis hiv 1infektionsstatus er ukendt, tilbydes test for hiv-antistoffer.
English: • herbal remedies used to treat depression and anxiety, containing: St. John's wort (Hypericum perforatum)
Danish: • naturlægemider, der anvendes til behandling af depression og angst, og som indeholder: perikon (hypericum perforatum)
English: You do not need to take another tablet if you are sick (vomit) more than 1 hour after taking Vemlidy.
Danish: Du skal ikke tage en ny tablet, hvis du kaster op mere end 1 time efter, at du har taget Vemlidy.
English: HBV DNA < 29 IU/mL Treatment differenceb
Danish: HBV-DNA < 29 IE/ml Behandlingsforskelb
English: Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Danish: Tenofoviralafenamid elimineres primært efter metabolisering til tenofovir.
English: Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3.
Danish: Tenofoviralafenamid trænger ind i primære hepatocytter ved passiv diffusion og via de hepatiske optagelsestransportører OATP1B1 og OATP1B3.
English: Vemlidy contains lactose
Danish: Vemlidy indeholder lactose
English: When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Danish: Efter korrektion for proteinbinding er ubundne (frie) plasmakoncentrationer af tenofoviralafenamid sammenlignelige ved svært nedsat leverfunktion og normal leverfunktion.
English: Co-administration of Vemlidy with certain anticonvulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g. rifampicin, rifabutin and rifapentine) or St. John's wort, all of which are inducers of P-glycoprotein (P-gp) and may decrease tenofovir alafenamide plasma concentrations, is not recommended.
Danish: Samtidig administration af Vemlidy og visse antikonvulsiva (f.eks. carbamazepin, oxcarbazepin, phenobarbital og phenytoin), antimykobakterielle lægemidler (f.eks. rifampicin, rifabutin og rifapentin) eller perikon, som alle inducerer P-glykoprotein (P-gp) og kan nedsætte plasmakoncentrationen af tenofoviralafenamid, frarådes.
English: 1 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Danish: 1 Bivirkning identificeret under sikkerhedsovervågning efter markedsføring for lægemidler indeholdende tenofoviralafenamid.
English: Co-administration of such medicinal products with Vemlidy is not recommended.
Danish: Samtidig administration af sådanne lægemidler og Vemlidy frarådes.
English: The antiviral activity of tenofovir alafenamide was evaluated against a panel of isolates containing nucleos(t)ide reverse transcriptase inhibitor mutations in HepG2 cells.
Danish: Tenofoviralafenamids antivirale aktivitet blev evalueret mod et panel med isolater indeholdende nukleosid/nukleotid revers transkriptasehæmmer-mutationer i HepG2-celler.