natgillin/translations-raw huggingface dataset:
Diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence Hepatobiliary disorders
Pogosti driska, bruhanje, navzea, bolečine v trebuhu, abdominalna distenzija, flatulenca
Vemlidy met the non-inferiority criteria in achieving HBV DNA less than 29 IU/mL when compared to tenofovir disoproxil fumarate.
Zdravilo Vemlidy je izpolnilo kriterije za neinferiornost pri doseganju HBV DNA manj kot 29 i.e./ml v primerjavi z dizoproksiltenofovirijevim fumaratom.
Treatment of overdose with Vemlidy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
ki vključujejo spremljanje vitalnih znakov in opazovanje kliničnega stanja bolnika.
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.
Ocena neželenih učinkov temelji na združenih podatkih o varnosti iz 2 nadzorovanih študij 3. faze, v katerih je 866 bolnikov, okuženih s HBV, prejemalo tenofoviralafenamid 25 mg enkrat na dan na dvojno slepi način do konca 96. tedna (mediana trajanja izpostavljenosti zdravilu v slepi študiji je bila 104 tedne), ter iz izkušenj v obdobju trženja.
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Pri bolnikih s cirozo je morda tveganje za jetrno dekompenzacijo po poslabšanju hepatitisa večje, zato jih je treba med zdravljenjem skrbno nadzirati.
• Wind (flatulence)
• vetrovi (flatulenca)
However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Vendar pa je dizoproksiltenofovirijev fumarat zmanjšal indeks viabilnosti in telesno maso mladičev v peri- in postnatalni študiji toksičnosti pri odmerkih, toksičnih za mater.
If you forget to take Vemlidy
Če ste pozabili vzeti zdravilo Vemlidy
• antiviral medicines used to treat HIV, such as:
• protivirusna zdravila za zdravljenje okužbe z virusom HIV, kot so:
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.
Zdravilo Vemlidy filmsko obložene tablete so rumene, okrogle, z natisom (ali oznako) „GSI“ na eni strani tablete in „25“ na drugi strani tablete.
No clinically relevant differences in pharmacokinetics according to age or ethnicity have been identified.
Klinično pomembnih farmakokinetičnih razlik glede starosti ali etnične pripadnosti niso opredelili.
Patients must be advised that Vemlidy does not prevent the risk of transmission of HBV to others through sexual contact or contamination with blood.
Prenos HBV Bolnike je treba opozoriti, da zdravilo Vemlidy ne preprečuje tveganja za prenos HBV na druge pri spolnem odnosu ali pri kontaminaciji s krvjo.
HIV ANTIRETROVIRAL AGENTS - CCR5 RECEPTOR ANTAGONIST Maraviroc
PROTIRETROVIRUSNA ZDRAVILA ZA ZDRAVLJENJE OKUŽBE S HIV - ANTAGONIST RECEPTORJEV CCR5
• 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.
• Če je minilo manj kot 18 ur od takrat, ko običajno vzamete zdravilo Vemlidy, ga vzemite takoj, ko lahko, nato pa naslednji odmerek vzemite kot običajno.
Patients co-infected with HBV and hepatitis C or D virus
Bolniki s sočasno okužbo s HBV in virusom hepatitisa C ali D
ANTIFUNGALS Itraconazole Ketoconazole
ANTIMIKOTIKI itrakonazol ketokonazol
If you take more Vemlidy than you should
Če ste vzeli večji odmerek zdravila Vemlidy, kot bi smeli
Non-clinical studies in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Predklinične študije pri podganah in psih so pokazale, da sta primarna ciljna organa toksičnosti kosti in ledvice.
Flares after treatment discontinuation
Izbruhi po prekinitvi zdravljenja
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).
V obeh študijah je bil tenofoviralafenamid povezan z manjšimi spremembami varnostnih parametrov delovanja ledvic (manjše mediano zmanjšanje ocenjenega CrCl po lestvici Cockcroft-Gault in manjše mediano odstotno povečanje razmerja beljakovin v urinu, ki vežejo retinol, glede na kreatinin in razmerja beta-2-mikroglobulina v urinu glede na kreatinin) v primerjavi z dizoproksiltenofovirijevim fumaratom po 96. tednih zdravljenja (glejte tudi poglavje 4.4).
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Na voljo so naslednje velikosti pakiranja: zunanja škatla, ki vsebuje 1 HDPE vsebnik s 30 filmsko obloženimi tabletami in škatle z 90 (3 HDPE vsebniki po 30) filmsko obloženimi tabletami.
d Includes patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy, e.g.
d Vključuje bolnike, ki sodelovanja niso prekinili zaradi neželenih učinkov, smrti ali pomanjkanja ali izgube učinka, temveč zaradi drugih razlogov, npr. zaradi umika soglasja, izgubljenosti za spremljanje itd.
Vemlidy comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Zdravilo Vemlidy je na voljo v HDPE vsebnikih s 30 tabletami (s sušilnim sredstvom iz silikagela, ki mora ostati v vsebniku za zaščito tablet).
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.
Pri bolnikih, ki so se prenehali zdraviti zaradi hepatitisa B, so poročali o akutnem poslabšanju hepatitisa, običajno v povezavi z naraščajočimi vrednostmi DNA HBV v plazmi.
The EC50 (50% effective concentration) values for tenofovir alafenamide ranged from 34.7 to 134.4 nM, with an overall mean EC50 of 86.6 nM.
Vrednosti EC50 (srednje efektivna koncentracija) za tenofoviralafenamid so v razponu od 34,7 do 134,4 nM, s splošnim povprečjem EC50 86,6 nM. CC50 (srednja citotoksična koncentracija) v celicah HepG2 je bila > 44.400 nM.
• antibiotics used to treat bacterial infections including tuberculosis, containing:
• antibiotike, ki se uporabljajo za zdravljenje bakterijskih okužb, vključno s tuberkulozo,
It is important not to miss a dose of Vemlidy.
Pomembno je, da ne pozabite vzeti nobenega odmerka zdravila Vemlidy.
It is not known whether tenofovir alafenamide is secreted in human milk.
Ni znano, ali se tenofoviralafenamid izloča v človeško mleko.
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.
Tenofovir difosfat je šibek zaviralec sesalske DNA-polimeraze, ki vključuje mitohondrijsko DNA-polimerazo γ; znakov mitohondrijske toksičnosti in vitro na podlagi številnih testov, vključno z analizami mitohondrijske DNA, ni.
Do not give this medicine to children who are under 12 years old or weigh less than 35 kg.
Otroci in mladostniki Tega zdravila ne dajajte otrokom, starim manj kot 12 let ali s telesno maso manj kot 35 kg.
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.
Študije in vitro so pokazale, da se tenofoviralafenamid presnavlja v tenofovir (glavni presnovek) s karboksilesterazo-1 v hepatocitih; in s katepsinom A v perifernih mononuklearnih krvnih celicah (PBMC) in makrofagih.
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.
V združeni analizi bolnikov, ki so prejemali zdravilo Vemlidy, so opravili analizo zaporedja na parnih izhodiščnih izolatih in izolatih HBV med zdravljenjem pri bolnikih, ki so imeli povečanje virusnega bremena (2 zaporedna obiska s HBV DNA ≥ 69 i.e./ml po povečanju < 69 i.e./ml ali 1,0 log10 ali več v HBV DNA od najnižje točke), ali bolnikih, ki so imeli HBV DNA ≥ 69 i.e./ml v 96. tednu ali ob predčasni prekinitvi v 24. tednu ali po njem.
Tenofovir is renally eliminated from the body by the kidneys by both glomerular filtration and active tubular secretion.
Tenofovir se iz telesa izloča z ledvicami s pomočjo glomerularne filtracije in aktivnega tubularnega izločanja.
g The predominant circulating nucleoside metabolite of sofosbuvir.
g Prevladujoči nukleozidni presnovek sofosbuvirja v obtoku.
In analyses at Week 48 (N = 20) and Week 96 (N = 72), no amino acid substitutions associated with resistance to Vemlidy were identified in these isolates (genotypic and phenotypic analyses).
V analizah v 48. tednu (N = 20) in 96. tednu (N = 72) v teh izolatih niso identificirali nobenih substitucij aminokislin z odpornostjo na zdravilo Vemlidy
Each bottle contains silica gel desiccant and polyester coil.
En vsebnik vsebuje sušilno sredstvo s silikagelom in poliestrsko vato.
If you do miss a dose, work out how long since you should have taken it.
določite, koliko časa je minilo od takrat, ko bi ga morali vzeti:
Other medicines and Vemlidy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katero koli drugo zdravilo.
TDF = tenofovir disoproxil fumarate a Missing = failure analysis.
TDF = dizoproksiltenofovirijev fumarat a Manjkajoči = analiza odpovedi.
The safety and efficacy of Vemlidy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Varnost in učinkovitost zdravila Vemlidy pri otrocih, mlajših od 12 let ali s telesno maso < 35 kg, še nista bili dokazani.
1.8% (95% CI = -3.6% to 7.2%)
1,8 % (95-% IZ = -3,6 % do 7,2 %) -3,6 % (95-% IZ = -9,8 % do 2,6 %)
Increased ALT
Pogosti povečana ALT
When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Po korekciji za vezavo beljakovin so bile koncentracije nevezanega (prostega) tenofoviralafenamida v plazmi pri hudi okvari jeter in normalnem delovanju jeter podobne.
There are no safety data on the use of Vemlidy to treat HBV infected patients with CrCl < 30 mL/min.
Podatkov o varnosti uporabe zdravila Vemlidy za zdravljenje bolnikov, okuženih s HBV, s CrCl < 30 ml/min, ni.
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.
Zaradi manjše izpostavljenosti tenofovirju pri podganah in miših po dajanju tenofoviralafenamida v primerjavi z dizoproksiltenofovirijevim fumaratom so študije kancerogenosti in peri- ter postnatalne študije pri podganah izvedli samo z dizoproksiltenofovirijevim fumaratom.
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.
Klinično pomembnih razlik v farmakokinetiki tenofoviralafenamida ali tenofovirja med zdravimi osebami in bolniki s hudo okvaro ledvic (ocenjen CrCl > 15, a < 30 ml/min) v študijah tenofoviralafenamida niso opazili.
The mean age was 38 years, 64% were male, 82% were Asian, 17% were White and < 1% (5 subjects) were Black.
Povprečna starost je bila 38 let, 64 % je bilo moških, 82 % je bilo Azijcev, 17 % je bilo belcev in
HBV DNA < 29 IU/mL Treatment differenceb
HBV DNA < 29 i.e./ml Razlika v zdravljenjub
In patients with severe hepatic impairment, total plasma concentrations of tenofovir alafenamide and tenofovir are lower than those seen in subjects with normal hepatic function.
Jetrna okvara Pri bolnikih s hudo okvaro jeter so bile skupne koncentracije tenofoviralafenamida in tenofovirja v plazmi manjše kot pri osebah z normalnim delovanjem jeter.
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172).
Polivinilalkohol (E1203), titanov dioksid (E171), makrogol (E1521), smukec (E553b), rumen železov oksid (E172).
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.
Po peroralnem dajanju zdravila Vemlidy na tešče odraslim bolnikom s kroničnim hepatitisom B je bila najvišja koncentracija tenofoviralafenamida v plazmi opažena približno 0,48 ur po odmerku.
• If it is more than 18 hours after you usually take Vemlidy, then do not take the missed dose.
• Če je minilo več kot 18 ur od takrat, ko običajno vzamete zdravilo Vemlidy, ne vzemite izpuščenega odmerka.
Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Tenofoviralafenamid ima mediani razpolovni čas v plazmi 0,51 ur, tenofovir pa 32,37 ur.
Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Tenofoviralafenamid in vitro ni zaviralec CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali CYP2D6.
Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Presnova je glavna pot izločanja tenofoviralafenamida pri ljudeh in znaša > 80 % peroralnega odmerka.
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.
Pri bolnikih, ki so nadaljevali s slepim zdravljenjem po 96. tednu, je bila povprečna sprememba v odstotkih BMD pri vsaki skupini v 120. tednu podobna kot v 96. tednu.
• herbal remedies used to treat depression and anxiety, containing: St. John's wort (Hypericum perforatum)
• pripravke rastlinskega izvora, ki se uporabljajo za zdravljenje depresije in tesnobe, ki vsebujejo: šentjanževko (Hypericum perforatum),
Oxcarbazepine Phenobarbital
okskarbazepin fenobarbital
It is not known whether tenofovir can be removed by peritoneal dialysis.
ali se lahko tenofovir odstrani s peritonealno dializo.
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.
Za zdravila, ki so induktorji P-gp (npr. rifampicin, rifabutin, karbamazepin, fenobarbital ali šentjanževka), se pričakuje, da bodo zmanjšala koncentracije tenofoviralafenamida v plazmi, kar lahko povzroči izgubo terapevtskega učinka zdravila Vemlidy.
↔ Tenofovir alafenamide ↔ Raltegravir
↔ tenofoviralafenamid ↔ raltegravir
Tenofovir alafenamide exposures are dose proportional over the dose range of 8 to 125 mg.
Izpostavljenosti tenofoviralafenamidu so sorazmerne z odmerkom v razponu odmerka od 8 mg do
Vemlidy has not been tested in children aged less than 12 years old or weighing less than 35 kg.
Zdravila Vemlidy niso testirali pri otrocih, starih manj kot 12 let ali s telesno maso manj kot 35 kg.
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.
Minimalna infiltracija histiocitov je bila prisotna v očesu psov pri izpostavljenosti tenofoviralafenamidu približno 4-krat in pri tenofovirju 17-krat večja od pričakovane po dajanju tenofoviralafenamida.
On days of haemodialysis, Vemlidy should be administered after completion of haemodialysis treatment (see section 5.2).
Ob dneh s hemodializo je treba zdravilo Vemlidy dati po končanju zdravljenja s hemodializo (glejte poglavje 5.2).
HIV antibody testing should be offered to all HBV infected patients whose HIV-1 infection status is unknown before initiating therapy with Vemlidy.
Vsem osebam, okuženim s HBV, in z neznanim statusom okužbe s HIV-1, je treba ponuditi testiranje za protitelesa za HIV pred začetkom zdravljenja z zdravilom Vemlidy.
Musculoskeletal and connective tissue disorders Common
Bolezni mišično-skeletnega sistema in vezivnega tkiva
• Do not breast-feed during treatment with Vemlidy.
• Med zdravljenjem z zdravilom Vemlidy ne dojite.
The use of Vemlidy is not recommended in patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.2).
Uporaba zdravila Vemlidy ni priporočljiva pri bolnikih s CrCl < 15 ml/min, ki ne prejemajo hemodialize (glejte poglavje 4.2).
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.
Pri bolnikih, ki so nadaljevali s slepim zdravljenjem po 96. tednu v študijah 108 in 110, je bila sprememba laboratorijskih vrednosti ledvičnih parametrov od izhodiščne vrednosti pri vsaki skupini v 120. tednu podobna kot v 96. tednu.
Co-administration of such medicinal products with Vemlidy is not recommended.
Sočasno dajanje teh zdravil z zdravilom Vemlidy se ne priporoča.
The most frequently reported adverse reactions were headache (12%), nausea (6%), and fatigue (6%).
(12 %), navzea (6 %) in utrujenost (6 %).
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).
Izolati HBV, ki izražajo enojne substitucije rtA181T, rtA181V ali rtN236T, povezane z odpornostjo na adefovir, so ostali občutljivi na tenofoviralafenamid; vendar pa so izolati HBV, ki izražajo rtA181V plus rtN236T, kazali zmanjšano občutljivost na tenofoviralafenamid (3,7-kratna sprememba EC50).
Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Tenofoviralafenamid je fosfonamidatno predzdravilo tenofovirja (analog 2'-deoksiadenozin monofosfata).
Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3.
Tenofoviralafenamid vstopa v primarne hepatocite s pasivno difuzijo in s transporterji jetrnega privzema OATP1B1 in OATP1B3.
HBV isolates expressing the rtL180M, rtM204V plus rtT184G, rtS202G, or rtM250V substitutions associated with resistance to entecavir remained susceptible to tenofovir alafenamide.
Izolati HBV, ki izražajo substitucije rtL180M, rtM204V plus rtT184G, rtS202G ali rtM250V, povezane z odpornostjo na entekavir, so ostali občutljivi na tenofoviralafenamid.
Lactose monohydrate Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Jedro tablete laktoza monohidrat mikrokristalna celuloza (E460(i)) premreženi natrijev karmelozat (E468) magnezijev stearat (E470b)
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women.
Podatkov o uporabi tenofoviralafenamida pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
Table 2: Adverse drug reactions identified with tenofovir alafenamide
Preglednica 2: Neželeni učinki zdravila, opredeljeni s tenofoviralafenamidom
If you are sick (vomit) less than 1 hour after taking Vemlidy, take another tablet.
Če vam je slabo (bruhate) manj kot 1 uro po uporabi zdravila Vemlidy, vzemite še eno tableto.
 If any of these apply to you, talk to your doctor before taking Vemlidy.
 Če kar koli od navedenega velja za vas, se pred jemanjem zdravila Vemlidy posvetujte z zdravnikom.
Co-administration of strong inhibitors of P-gp with Vemlidy is not recommended.
Sočasno dajanje močnih zaviralcev P-gp z zdravilom Vemlidy ni priporočljiva.
e The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline.
e Populacija, uporabljena za serološko analizo, je vključevala samo bolnike s pozitivnim antigenom (HBeAg) in negativnim ali manjkajočim protitelesom (HBeAb) ob izhodišču.
Tenofovir has activity that is specific to hepatitis B virus and human immunodeficiency virus (HIV-1 and HIV-2).
Tenofovir ima aktivnost, specifično za virus hepatitisa B in za virus človeške imunske pomanjkljivosti
d The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline.
d Populacija, uporabljena za analizo serologije, je vključevala le bolnike, pozitivne za antigen (HBeAg) in negativne ali manjkajoče za protitelesa (HBeAb) ob izhodišču.
The antiviral activity of tenofovir alafenamide was assessed in HepG2 cells against a panel of HBV clinical isolates representing genotypes A-H.
Protivirusna aktivnost Protivirusna aktivnost tenofoviralafenamida je bila ocenjena v celicah HepG2 v baterijskem testu kliničnih izolatov HBV, ki predstavljajo genotipe A-H.
Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.
4.2 Odmerjanje in način uporabe Zdravljenje mora začeti zdravnik, ki že ima izkušnje z zdravljenjem kroničnega hepatitisa B.
Normalised ALT (Central lab)c Normalised ALT (AASLD)d Serology
Normalizirana ALT (centralni laboratorij)c Normalizirana ALT (AASLD)d
Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
Tenofoviralafenamid je in vitro substrat OATP1B1 in OATP1B3.
Hepatitis B and HIV co-infection
Sočasna okužba s hepatitisom B in HIV
Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes.
Tenofoviralafenamid se primarno hidrolizira v tenofovir s pomočjo karboksilesteraze 1 v primarnih hepatocitih.
What you need to know before you take Vemlidy Do not take Vemlidy
Kaj morate vedeti, preden boste vzeli zdravilo Vemlidy Ne jemljite zdravila Vemlidy:
↔ Tenofovir alafenamide ↔ Nevirapine
↔ tenofoviralafenamid ↔ nevirapin
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.
Ob izhodišču je bila povprečna vrednost HBV DNA v plazmi 7,6 log10 i.e./ml, povprečna vrednost serumske ALT je bila 120 e./l in 7 % bolnikov je imelo cirozo v anamnezi.
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.
V študiji 110 so bili HBeAg-pozitivni, predhodno nezdravljeni in predhodno zdravljeni bolniki s kompenziranim delovanjem jeter randomizirani v razmerju 2 : 1 za prejemanje zdravila Vemlidy (25 mg; N = 581) enkrat na dan ali dizoproksiltenofovirijev fumarat (300 mg; N = 292) enkrat na dan.
• Take steps to avoid getting pregnant during treatment with Vemlidy.
• Z ustreznimi ukrepi preprečite zanositev med zdravljenjem z zdravilom Vemlidy.
Co-administration of Vemlidy with medicinal products that inhibit P-gp and BCRP may increase plasma concentrations of tenofovir alafenamide.
Sočasno dajanje zdravila Vemlidy z zdravili, ki zavirajo P-gp in BCRP, lahko poveča koncentracije tenofoviralafenamida v plazmi.