natgillin/translations-raw huggingface dataset:
Efter korrektion for proteinbinding er ubundne (frie) plasmakoncentrationer af tenofoviralafenamid sammenlignelige ved svært nedsat leverfunktion og normal leverfunktion.
When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
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.
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.
1 Bivirkning identificeret under sikkerhedsovervågning efter markedsføring for lægemidler indeholdende tenofoviralafenamid.
1 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Samtidig administration af sådanne lægemidler og Vemlidy frarådes.
Co-administration of such medicinal products with Vemlidy is not recommended.
Tenofoviralafenamids antivirale aktivitet blev evalueret mod et panel med isolater indeholdende nukleosid/nukleotid revers transkriptasehæmmer-mutationer i HepG2-celler.
The antiviral activity of tenofovir alafenamide was evaluated against a panel of isolates containing nucleos(t)ide reverse transcriptase inhibitor mutations in HepG2 cells.
Der foreligger ingen data om Vemlidys sikkerhed og virkning hos patienter, der også er inficeret med hepatitis C- eller D-virus.
There are no data on the safety and efficacy of Vemlidy in patients co-infected with hepatitis C or D virus.
Vemlidy kan give svimmelhed.
Vemlidy can cause dizziness.
Vemlidy er indiceret til behandling af kronisk hepatitis B hos voksne og unge (i alderen 12 år og derover med en legemsvægt på mindst 35 kg) (se pkt.
Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg) (see section 5.1).
↔ Tenofoviralafenamid ↔ Raltegravir
↔ Tenofovir alafenamide ↔ Raltegravir
I begge studier var tenofoviralafenamid efter 96 ugers behandling forbundet med mindre ændringer i renale sikkerhedsparametre (mindre gennemsnitsreduktioner i estimeret CrCl via Cockcroft Gaultmetoden og mindre gennemsnitlige procentvise stigninger i forholdet mellem retinolbindende protein og kreatinin i urinen og forholdet mellem beta 2-mikroglobulin og kreatinin i urinen) sammenlignet med tenofovirdisoproxilfumarat (se også pkt.
In both studies tenofovir alafenamide was associated with smaller changes in renal safety parameters (smaller median reductions in estimated CrCl by Cockcroft-Gault and smaller median percentage increases in urine retinol binding protein to creatinine ratio and urine beta-2-microglobulin to creatinine ratio) compared to tenofovir disoproxil fumarate after 96 weeks of treatment (see also section 4.4).
Ældre Dosisjustering af Vemlidy er ikke nødvendig hos patienter på 65 år og derover (se pkt.
Elderly No dose adjustment of Vemlidy is required in patients aged 65 years and older (see section 5.2).
Lægemidler, der inducerer P-gp (f.eks. rifampicin, rifabutin, carbamazepin, phenobarbital og perikon) forventes at nedsætte plasmakoncentrationen af tenofoviralafenamid, hvilket kan medføre tab af Vemlidys terapeutiske virkning.
Medicinal products that are P-gp inducers (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital or St. John's wort) are expected to decrease plasma concentrations of tenofovir alafenamide, which may lead to loss of therapeutic effect of Vemlidy.
• Du må ikke amme, mens du er i behandling med Vemlidy.
• Do not breast-feed during treatment with Vemlidy.
Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol (E1521) Talcum (E553b) Gul jernoxid (E172)
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b) Iron oxide yellow (E172)
Tenofoviralafenamid hydrolyseres primært til tenofovir via carboxylesterase-1 i primære hepatocytter.
Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes.
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 95 mg lactose (som monohydrat).
Each tablet contains 95 mg lactose (as monohydrate).
c. Behandlingsnaive patienter fik < 12 ugers oral antiviral behandling med en hvilken som helst nukleosid- eller nukleotidanalog, herunder tenofovirdisoproxilfumarat eller tenofoviralafenamid.
c Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide.
e. Populationen anvendt til serologianalyse omfattede kun patienter med antigen (HBeAg)-positiv og antistof (HBeAb)negativ eller manglende ved baseline.
e The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline.
Normaliseret ALAT (centrallaboratorium)c Normaliseret ALAT (AASLD)d
Normalised ALT (Central lab)c Normalised ALT (AASLD)d Serology
Isolater af HBV, der udtrykte enkeltsubstitutionerne rtA181T, rtA181V eller rtN236T associeret med resistens over for adefovir, forblev følsomme for tenofoviralafenamid, men det HBV-isolat, der udtrykte rtA181V plus rtN236T, viste nedsat følsomhed for tenofoviralafenamid (3,7 gange ændring i EC50).
HBV isolates expressing the rtA181T, rtA181V, or rtN236T single substitutions associated with resistance to adefovir remained susceptible to tenofovir alafenamide; however, the HBV isolate expressing rtA181V plus rtN236T exhibited reduced susceptibility to tenofovir alafenamide (3.7-fold change in EC50).
Tenofoviralafenamid er substrat for OATP1B1 og OATP1B3 in vitro.
Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
• tenofovir-disoproxilfumarat
• tenofovir disoproxil fumarate
Lactosemonohydrat Mikrokrystallinsk cellulose (E460(i)) Croscarmellosenatrium (E468) Magnesiumstearat (E470b)
Lactose monohydrate Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Det er ukendt, om tenofoviralafenamid udskilles i human mælk.
It is not known whether tenofovir alafenamide is secreted in human milk.
Vemlidy 25 mg filmovertrukne tabletter.
Vemlidy 25 mg film-coated tablets.
Polyvinylalkohol (E1203), titandioxid (E171), macrogol (E1521), talcum (E553b), gul jernoxid (E172).
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172).
Hvis patienten glemmer at tage en dosis inden for 18 timer efter det tidspunkt, hvor patienten normalt tager dosen, skal patienten tage Vemlidy så snart som muligt og derefter fortsætte med den normale doseringsplan.
If a dose is missed and less than 18 hours have passed from the time it is usually taken, the patient should take Vemlidy as soon as possible and then resume their normal dosing schedule.
Vemlidys sikkerhed er også understøttet af samlede data fra patienter i studie 108 og 110, som forblev på blindet behandling fra uge 96 til og med uge 120 og endvidere fra patienter i den ikke-blindede fase af studie 108 og 110 fra uge 96 til og med uge 120 (N = 361 forblev på Vemlidy, N = 180 skiftede fra tenofovirdisoproxilfumarat til Vemlidy i uge 96).
The safety of Vemlidy is also supported by pooled data from patients in Studies 108 and 110 who remained on blinded treatment from Week 96 through Week 120 and additionally from patients in the open-label phase of Studies 108 and 110 from Week 96 through Week 120 (N = 361 remained on Vemlidy; N = 180 switched from tenofovir disoproxil fumarate to Vemlidy at Week 96).
N/A = ikke relevant TDF = tenofovirdisoproxilfumarat A Manglende = fejlanalyse.
TDF = tenofovir disoproxil fumarate a Missing = failure analysis.
På dage med hæmodialyse skal Vemlidy administreres, når hæmodialysen er fuldført (se pkt.
On days of haemodialysis, Vemlidy should be administered after completion of haemodialysis treatment (see section 5.2).
Systemorganklasse Hyppighed Bivirkning Almindelig
System organ class Frequency
↔ Tenofoviralafenamid ↔ Maraviroc
↔ Tenofovir alafenamide ↔ Maraviroc
Ved baseline var middelværdien for plasma-HBV-DNA 5,8 log10 IE/ml, middelværdien for serum-ALAT var 94 E/l, og 9 % af patienterne havde cirrose i anamnesen.
At baseline, mean plasma HBV DNA was 5.8 log10 IU/mL, mean serum ALT was 94 U/L, and 9% of patients had a history of cirrhosis.
Samtidig administration af Vemlidy og lægemidler, der hæmmer P-gp og BCRP, kan øge plasmakoncentrationen af tenofoviralafenamid.
Co-administration of Vemlidy with medicinal products that inhibit P-gp and BCRP may increase plasma concentrations of tenofovir alafenamide.
Virkningen af tenofoviralafenamid på andre lægemidler Tenofoviralafenamid hæmmer ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6 in vitro.
Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Lactosemonohydrat, mikrokrystallinsk cellulose (E460(i)), croscarmellosenatrium (E468), magnesiumstearat (E470b).
Lactose monohydrate, microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), magnesium stearate (E470b).
 Fortæl det til lægen, hvis nogen af disse bivirkninger bliver alvorlige.
 If any of these side effects get serious tell your doctor.
Ved baseline var middelværdien for plasma-HBV-DNA 7,6 log10 IE/ml, middelværdien for serum-ALAT var 120 E/l, og 7% af patienterne havde cirrose i anamnesen.
At baseline, mean plasma HBV DNA was 7.6 log10 IU/mL, mean serum ALT was 120 U/L, and 7% of patients had a history of cirrhosis.
Isolater af HBV, der udtrykte rtL180M-, rtM204V- plus rtT184G-, rtS202G- eller rtM250V-substitutioner associeret med resistens over for entecavir, forblev følsomme for tenofoviralafenamid.
HBV isolates expressing the rtL180M, rtM204V plus rtT184G, rtS202G, or rtM250V substitutions associated with resistance to entecavir remained susceptible to tenofovir alafenamide.
I Studie 108 blev HBeAg-negative behandlingsnaive og behandlingserfarne patienter med kompenseret leverfunktion randomiseret i forholdet 2:1 til at få Vemlidy (25 mg; N = 285) en gang dagligt eller tenofovirdisoproxilfumarat (300 mg; N = 140) en gang dagligt.
In Study 108, HBeAg-negative treatment-naïve and treatment-experienced patients with compensated liver function were randomised in a 2:1 ratio to receive Vemlidy (25 mg; N = 285) once daily or tenofovir disoproxil fumarate (300 mg; N = 140) once daily.
I Studie 110 blev HBeAg-positive behandlingsnaive og behandlingserfarne patienter med kompenseret leverfunktion randomiseret i forholdet 2:1 til at få Vemlidy (25 mg; N = 581) en gang dagligt eller tenofovirdisoproxilfumarat (300 mg; N = 292) en gang dagligt.
In Study 110, HBeAg-positive treatment-naïve and treatment-experienced patients with compensated liver function were randomised in a 2:1 ratio to receive Vemlidy (25 mg; N = 581) once daily or tenofovir disoproxil fumarate (300 mg; N = 292) once daily.
↔ Tenofoviralafenamid ↔ Nevirapin
↔ Tenofovir alafenamide ↔ Nevirapine
Det bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
I prøver indsamlet under kliniske studier var bindingen af tenofoviralafenamid til humane plasmaproteiner ca. 80 %.
The binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Tabel 2: Bivirkninger identificeret med tenofoviralafenamid
Table 2: Adverse drug reactions identified with tenofovir alafenamide
Samtidig administration af Vemlidy og potente P-gp-hæmmere (f.eks. itraconazol og ketoconazol) kan øge plasmakoncentrationen af tenofoviralafenamid.
Co-administration of Vemlidy with strong inhibitors of P-gp (e.g. itraconazole and ketoconazole) may increase tenofovir alafenamide plasma concentrations.
Behandlingsophør Behandlingsophør bør overvejes i følgende tilfælde (se pkt.
Treatment discontinuation Treatment discontinuation may be considered as follows (see section 4.4):
Samtidig administration af potente P-gp-hæmmere og Vemlidy frarådes.
Co-administration of strong inhibitors of P-gp with Vemlidy is not recommended.
Vemlidy-tabletter er pakket i beholdere af højdensitetspolyethylen (HDPE) med børnesikret skruelåg af popypropylen med kontinuerligt gevind, foret med induktionsaktiveret aluminiumsfolie.
Vemlidy tablets are packaged in high density polyethylene (HDPE) bottles and enclosed with a polypropylene continuous-thread, child-resistant cap, lined with an induction-activated aluminium foil liner.
Isolater af HBV, der udtrykte rtV173L-, rtL180M- og rtM204V/I-substitutioner associeret med resistens over for lamivudin, forblev følsomme for tenofoviralafenamid (< 2 gange ændring i EC50).
HBV isolates expressing the rtV173L, rtL180M, and rtM204V/I substitutions associated with resistance to lamivudine remained susceptible to tenofovir alafenamide (< 2-fold change in EC50).
Midazolamd (1 mg i.v., enkeltdosis)
Midazolamd (1 mg IV, s.d.)
Det skal du vide, før du begynder at tage Vemlidy Tag ikke Vemlidy:
What you need to know before you take Vemlidy Do not take Vemlidy
Vemlidy indeholder lactosemonohydrat.
Vemlidy contains lactose monohydrate.
Hvis patienten kaster op mere end 1 time efter at have taget Vemlidy, skal der ikke tages ny tablet.
If the patient vomits more than 1 hour after taking Vemlidy, the patient does not need to take another tablet.
Amning frarådes, så dit barn ikke får tenofoviralafenamid eller tenofovir gennem mælken.
It is recommended that you do not breast-feed to avoid passing tenofovir alafenamide or tenofovir to the baby through breast milk.
Det vides ikke, om tenofoviralafenamid hæmmer andre UGT-enzymer.
It is not known whether tenofovir alafenamide is an inhibitor of other UGT enzymes.
Opblussen efter behandlingsophør
Flares after treatment discontinuation
Lægen afgør, hvor længe behandlingen skal fortsætte.
Treatment should continue for as long as your doctor tells you.
NATURLÆGEMIDLER Perikon (hypericum perforatum)
HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
I den ikke-blindede fase i studie 108 og 110 var den gennemsnitlige (+SD) ændring i serumkreatinin fra uge 96 til uge 120 -0,002 (0,10) mg/dl hos dem, som forblev på Vemlidy, sammenlignet med0,008 (0,09) mg/dl hos dem, som skiftede fra tenofovirdisoproxilfumarat til Vemlidy i uge 96.
In the open-label phase of Studies 108 and 110, the mean (±SD) change in serum creatinine from Week 96 to Week 120 was -0.002 (0.10) mg/dL in those who remained on Vemlidy, compared to -0.008 (0.09) mg/dL in those who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
Ethinylestradiol (0,025 mg oralt, en gang dagligt)
Ethinylestradiol (0.025 mg orally, q.d.)
Giv ikke dette lægemiddel til børn under 12 år eller børn, som vejer under 35 kg. Vemlidy er ikke blevet undersøgt hos børn under 12 år eller børn, som vejer under 35 kg.
Do not give this medicine to children who are under 12 years old or weigh less than 35 kg.
ANTIRETROVIRALE MIDLER MOD HIV - PROTEASEHÆMMERE Atazanavir/cobicistat (300 mg/150 mg oralt, en gang dagligt)
HIV ANTIRETROVIRAL AGENTS - PROTEASE INHIBITORS Atazanavir/cobicistat (300 mg/150 mg orally, q.d.)
• Du skal beskytte dig mod graviditet, mens du er i behandling med Vemlidy.
• Take steps to avoid getting pregnant during treatment with Vemlidy.
ANTIRETROVIRALE MIDLER MOD HIV - NON-NUKLEOSID REVERS TRANSKRIPTASEHÆMMERE Efavirenz (600 mg oralt, en gang dagligt)
HIV ANTIRETROVIRAL AGENTS - NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Efavirenz (600 mg orally, q.d.)
d. Den anvendte population til serologisk analyse omfattede kun patienter, som var antigen (HBeAg)-positive og enten antistof (HBeAb)-negative eller med manglende resultat for antistofbestemmelse ved baseline.
d The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline.
c. Den anvendte population til analyse af normalisering af ALAT omfattede kun patienter med baseline-ALAT over ULN i henhold til kriterierne fra AASLD (American Association of the Study of Liver Diseases) (> 30 E/l for mænd og > 19 E/l for kvinder).
c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the American Association of the Study of Liver Diseases (AASLD) criteria (> 30 U/L males and > 19 U/L females) at baseline.
I studier af tenofoviralafenamid blev der ikke observeret klinisk relevante forskelle i farmakokinetikken for tenofoviralafenamid eller tenofovir mellem raske personer og patienter med svært nedsat nyrefunktion (estimeret CrCl > 15 men < 30 ml/min).
No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl > 15 but < 30 mL/min) in studies of tenofovir alafenamide.
I den ikke-blindede fase i begge studier var den gennemsnitlige procentvise ændring i BMD fra uge 96 til uge 120 hos patienter, som forblev på Vemlidy, +0,6 % ved lænderyg og 0 % ved hofte, sammenlignet med +1,7 % ved lænderyg og +0,6 % ved hofte hos dem, som skiftede fra tenofovirdisoproxilfumarat til Vemlidy i uge 96.
In the open-label phase of both studies, mean percentage change in BMD from Week 96 to Week 120 in patients who remained on Vemlidy was +0.6% at the lumbar spine and 0% at the total hip, compared to +1.7% at the lumbar spine and +0.6% at the total hip in those who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
Lægemidler, der kan påvirke tenofoviralafenamid
Medicinal products that may affect tenofovir alafenamide
Vemlidy 25 mg filmovertrukne tabletter tenofoviralafenamid
Vemlidy 25 mg film-coated tablets tenofovir alafenamide
HBsAg-tab/serokonversion
HBsAg loss / seroconversion
Vemlidy bør ikke administreres sammen med lægemidler, som indeholder tenofoviralafenamid, tenofovirdisoproxilfumarat eller adefovirdipivoxil.
Vemlidy should not be co-administered with medicinal products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil.
Midazolamd (2,5 mg oralt, enkeltdosis)
Midazolamd (2.5 mg orally, s.d.)
Ved sammenligning med tenofovirdisoproxilfumarat opfyldte Vemlidy kriteriet for noninferioritet i at opnå HBV-DNA under 29 IE/ml.
Vemlidy met the non-inferiority criteria in achieving HBV DNA less than 29 IU/mL when compared to tenofovir disoproxil fumarate.
Vemlidy bør ikke administreres sammen med lægemidler, der indeholder tenofovirdisoproxilfumarat, tenofoviralafenamid eller adefovirdipivoxil.
Vemlidy should not be co-administered with medicinal products containing tenofovir disoproxil fumarate, tenofovir alafenamide or adefovir dipivoxil.
Forventet: ↓ Tenofoviralafenamid
Expected: ↓ Tenofovir alafenamide
c. Den anvendte population til analyse af normalisering af ALAT omfattede kun patienter med baseline-ALAT over ULN for centrallaboratoriets interval.
c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the central laboratory range at baseline.
Vemlidy bruges til behandling af kronisk (langvarig) hepatitis B hos voksne og unge over 12 år, som vejer mindst 35 kg. Hepatitis B er en infektion, som påvirker leveren.
Vemlidy is used to treat chronic (long-term) hepatitis B in adults and adolescents 12 years of age and older, who weigh at least 35 kg.
Sertralin (50 mg oralt, enkeltdosis)
Sertraline (50 mg orally, s.d.)
Der kan ikke gives dosisanbefalinger for patienter med CrCl < 15 ml/min, som ikke er i hæmodialyse (se pkt.
No dosing recommendations can be given for patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.4).
d. Den anvendte population til analyse af normalisering af ALAT omfattede kun patienter med baseline-ALAT over ULN for kriterierne fra AASLD (> 30 E/l for mænd og > 19 E/l for kvinder).
d The population used for analysis of ALT normalisation included only patients with ALT above ULN of the AASLD criteria (> 30 U/L males and > 19 U/L females) at baseline.
Dosisjustering af Vemlidy eller norgestimat/ethinylestradiol er ikke nødvendig.
No dose adjustment of Vemlidy or norgestimate/ethinyl estradiol is required.
Tenofoviralafenamids og tenofovirs farmakokinetik blev vurderet hos hiv 1-inficerede, behandlingsnaive unge, som fik tenofoviralafenamid (10 mg) sammen med elvitegravir, cobicistat og emtricitabin som en fastdosis-kombinationstablet (E/C/F/TAF; Genvoya).
The pharmacokinetics of tenofovir alafenamide and tenofovir were evaluated in HIV-1 infected, treatment-naïve adolescents who received tenofovir alafenamide (10 mg) given with elvitegravir,
Serologi HBeAg-tab/serokonversiond
Serology HBeAg loss / seroconversiond
b. Den anvendte population til analyse af normalisering af ALAT omfattede kun patienter med baseline-ALAT over den øvre normalgrænse (ULN) for centrallaboratoriets interval.
b The population used for analysis of ALT normalisation included only patients with ALT above upper limit of normal (ULN) of the central laboratory range at baseline.
Tenofoviralafenamid ↑ Cmax 1,77 (1,28; 2,44)
Tenofovir alafenamide ↑ Cmax 1.77 (1.28, 2.44)
Henholdsvis 24 %, 38 % og 31 % havde HBV-genotype B, C og D. 21 % var behandlingserfarne (tidligere behandling med orale antivirale midler, herunder entecavir (N = 41), lamivudin (N = 42), tenofovirdisoproxilfumarat (N = 21) eller andet (N = 18)).
21% were treatment-experienced (previous treatment with oral antivirals, including entecavir (N = 41), lamivudine (N = 42), tenofovir disoproxil fumarate (N = 21), or other (N = 18)).
Hvis patienten kaster op inden for 1 time efter at have taget Vemlidy, skal der tages en ny tablet.
If the patient vomits within 1 hour of taking Vemlidy, the patient should take another tablet.
Tenofoviralafenamid ↑ Cmax 1,42 (0,96; 2,09)
Tenofovir alafenamide ↑ Cmax 1.42 (0.96, 2.09)
Hvis du kaster op mindre end 1 time efter, at du har taget Vemlidy, skal du tage en ny tablet.
If you are sick (vomit) less than 1 hour after taking Vemlidy, take another tablet.
Aktivt stof: tenofoviralafenamid.
The active substance is tenofovir alafenamide.
• Ledsmerter (artralgi)
• Wind (flatulence)
ANTIDEPRESSIVA Sertralin (50 mg oralt, enkeltdosis) Tenofoviralafenamide (10 mg oralt, en gang dagligt)
ANTIDEPRESSANTS Sertraline (50 mg orally, s.d.) Tenofovir alafenamidee (10 mg orally, q.d.)
Det frarådes at anvende Vemlidy til patienter med CrCl < 15 ml/min, som ikke er i hæmodialyse (se pkt.
The use of Vemlidy is not recommended in patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.2).
Darunavir/cobicistat (800 mg/150 mg oralt, en gang dagligt)
Darunavir/cobicistat (800 mg/150 mg orally, q.d.)
Det kan være, at din læge vil tage blodprøver for at holde øje med, hvordan dine nyrer virker.
Before starting treatment and during treatment, your doctor may order blood tests to monitor how your kidneys work.
Henholdsvis 17 %, 52 % og 23 % havde HBV-genotype B, C og D. 26 % var behandlingserfarne (tidligere behandling med orale antivirale midler, herunder adefovir (N = 42), entecavir (N = 117), lamivudin (N = 84), telbivudin (N = 25), tenofovirdisoproxilfumarat (N = 70) eller andet (N = 17)).
26% were treatment-experienced (previous treatment with oral antivirals, including adefovir (N = 42), entecavir (N = 117), lamivudine (N = 84), telbivudine
↔ Velpatasvir ↑ Tenofoviralafenamid
↑ Tenofovir alafenamide
HBV DNA ved baseline < 8 log10 IE/ml ≥ 8 log10 IE/ml
Baseline HBV DNA < 8 log10 IU/mL ≥ 8 log10 IU/mL
Dosisjustering af Vemlidy eller maraviroc er ikke nødvendig.
No dose adjustment of Vemlidy or maraviroc is required.
ANTIVIRALE MIDLER MOD HCV Sofosbuvir (400 mg oralt, en gang dagligt)
HCV ANTIVIRAL AGENTS Sofosbuvir (400 mg orally, q.d.)