natgillin/translations-raw huggingface dataset:
Medicines used in treating hepatitis B infection:
Zdravila, ki se uporabljajo za zdravljenje okužbe s hepatitisom B: Zdravila Descovy ne smete jemati z zdravili, ki vsebujejo:
In studies in treatment-naïve patients, emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat as a fixed-dose combination tablet through 144 weeks was associated with a lower impact on renal safety parameters (as measured after 144 weeks treatment by eGFRCG and urine protein to creatinine ratio and after 96 weeks treatment by urine albumin to creatinine ratio) compared to E/C/F/TDF.
V študijah pri predhodno nezdravljenih bolnikih je bil emtricitabin + tenofoviralafenamid v kombinaciji z elvitegravirjem + kobicistatom v obliki tablete s fiksno kombinacijo odmerkov do vključno 144. tedna zdravljenja povezan z manjšim vplivom na parametre varnosti za ledvice (izmerjene po 144 tednih zdravljenja z eGFRCG in razmerjem med beljakovinami in kreatininom v urinu ter po 96 tednih zdravljenja z razmerjem albumina in kreatinina v urinu) kot E/C/F/TDF.
Descovy 200 mg/10 mg [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Descovy 200 mg/10 mg [samo na zunanji ovojnini]
Rilpivirine (25 mg once daily), tenofovir alafenamide (25 mg once daily)
rilpivirin (25 mg enkrat dnevno), tenofoviralafenamid (25 mg enkrat dnevno)
The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1498).
Povprečno število celic CD4+ ob izhodišču je bilo 636 celic/mm3 (razpon 263-1.498).
Descovy 200 mg/25 mg [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Descovy 200 mg/25 mg [samo na zunanji ovojnini]
Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
uridine diphosphate glucuronosyltransferase) 1A1.
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Čeprav se je izkazalo, da učinkovita virusna supresija s protiretrovirusno terapijo bistveno zmanjša tveganje spolnega prenosa, preostalega tveganja ni mogoče izključiti.
No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, or tenofovir alafenamide.
Za emtricitabin ali tenofoviralafenamid ni bilo identificirane klinično pomembne farmakokinetične razlike glede na starost, spol ali etnično pripadnost.
Intravenously administered midazolam (1 mg single dose), tenofovir alafenamide (25 mg once daily)
intravenski midazolam (1 mg enkratni odmerek), tenofoviralafenamid (25 mg enkrat dnevno)
In studies in treatment-naïve patients, increases from baseline were observed in both the tenofovir alafenamide fumarate and tenofovir disoproxil fumarate containing treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
V študijah pri predhodno nezdravljenih bolnikih so v 144. tednu opazili povečanje od začetne vrednosti v obeh skupinah zdravljenja, v skupini s tenofoviralafenamidom in skupini z dizoproksiltenofovirijevim fumaratom, pri parametrih maščob na tešče za skupni holesterol, direktni holesterol lipoproteinov nizke gostote (low-density lipoprotein, LDL) ali LDL holesterol, holesterol lipoproteinov visoke gostote (high-density lipoprotein, HDL) ali HDL holesterol in trigliceride.
The safety of emtricitabine and tenofovir alafenamide was evaluated through 144 weeks in an openlabel clinical study (GS-US-292-0112) in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina in tenofoviralafenamida so ocenili v 144 tednih v odprti klinični študiji (GS-US-292-0112), v kateri je 248 bolnikov, okuženih s HIV-1, ki se bodisi predhodno še niso zdravili (n = 6) ali so imeli virusno supresijo (n = 242), z blago do zmerno ledvično okvaro (ocenjena hitrost glomerularne filtracije po metodi Cockcroft-Gault [eGFRCG]: 30-69 ml/min) prejemalo emtricitabin in tenofoviralafenamid v kombinaciji z elvitagravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
Descovy 200 mg/10 mg film-coated tablets
IME ZDRAVILA Descovy 200 mg/10 mg filmsko obložene tablete
Atazanavir with ritonavir or cobicistat Darunavir with ritonavir or cobicistat1 Lopinavir with ritonavir
Darunavir z ritonavirjem ali kobicistatom1
rifabutin, rifampicin, and rifapentine
- rifabutin, rifampicin in rifapentin
ANTIDEPRESSANTS Sertraline (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
ANTIDEPRESIVI sertralin (50 mg enkrat dnevno), tenofoviralafenamid (10 mg enkrat dnevno)3
While you are taking Descovy
Med jemanjem zdravila Descovy
In a separate study in treatment-naïve patients, emtricitabine and tenofovir alafenamide given with darunavir and cobicistat as a fixed-dose combination tablet was associated with a lower impact on renal safety parameters through 48 weeks of treatment compared to darunavir and cobicistat given with emtricitabine/tenofovir disoproxil fumarate (see also section 4.4).
V ločeni študiji pri predhodno nezdravljenih bolnikih je bil emtricitabin + tenofoviralafenamid v kombinaciji z darunavirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov do vključno 48. tedna zdravljenja povezan z manjšim vplivom na parametre varnosti za ledvice v primerjavi z darunavirjem in kobicistatom v kombinaciji z emtricitabinom/dizoproksiltenofovirijevim fumaratom (glejte tudi poglavje 4.4).
The active substances are emtricitabine and tenofovir alafenamide.
Učinkovini sta emtricitabin in tenofoviralafenamid.
Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 3,112 HIV-1 infected patients received medicinal products containing emtricitabine and tenofovir alafenamide and from post-marketing experience.
3.112 bolnikov, okuženih s HIV-1, prejemalo zdravila, ki so vsebovala emtricitabin in tenofoviralafenamid, ter iz izkušenj v obdobju trženja.
c Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 96 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
c Vključuje bolnike, ki so imeli v oknu 48. tedna ali 96. tedna ≥ 50 kopij/ml; bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka, bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
Package leaflet: Information for the user Descovy 200 mg/10 mg film-coated tablets emtricitabine/tenofovir alafenamide This medicine is subject to additional monitoring.
Navodilo za uporabo Descovy 200 mg/10 mg filmsko obložene tablete emtricitabin/tenofoviralafenamid Za to zdravilo se izvaja dodatno spremljanje varnosti.
Carbamazepine (titrated from 100 mg to 300 mg twice a day), emtricitabine/tenofovir alafenamide (200 mg/25 mg once daily) 5,6
karbamazepin (titriran s 100 mg na 300 mg dvakrat dnevno), emtricitabin/tenofoviralafenamid (200 mg/25 mg enkrat dnevno)5,6
HIV-1 isolates with reduced susceptibility to tenofovir alafenamide express a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Izolati HIV-1 z zmanjšano občutljivostjo za tenofoviralafenamid izražajo mutacijo K65R v HIV-1 RT.
Package leaflet: Information for the user Descovy 200 mg/25 mg film-coated tablets emtricitabine/tenofovir alafenamide This medicine is subject to additional monitoring.
Navodilo za uporabo Descovy 200 mg/25 mg filmsko obložene tablete emtricitabin/tenofoviralafenamid Za to zdravilo se izvaja dodatno spremljanje varnosti.
Antimycobacterials Rifabutin
Zdravila za zdravljenje okužb z mikobakterijami rifabutin rifampicin rifapentin
You must remain under the care of your doctor while taking Descovy.
Pri jemanju zdravila Descovy morate ostati pod zdravniškim nadzorom.
In Study GS-US-292-1825, the efficacy and safety of emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet were evaluated in a single arm, open-label clinical study in which 55 HIV-1 infected adults with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis for at least 6 months before switching to emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet.
V študiji GS-US-292-1825 so učinkovitost in varnost emtricitabina in tenofoviralafenamida, uporabljenih skupaj z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov, ocenili v odprti klinični študiji z eno skupino, v kateri je bilo 55 odraslih, okuženih s HIV-1, s končno ledvično odpovedjo (eGFRCG < 15 ml/min) na kronični hemodializi vsaj 6 mesecev pred prehodom na emtricitabin in tenofoviralafenamid, dana skupaj z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
E/C/F/TAF = elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1049 (inclusive).
E/C/F/TDF = evitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat a Okno v 48. tednu je med 294. in 377. dnevom (vključno z njima); okno v 144. tednu je med 966. in 1049. dnevom (vključno z njima).
b Includes patients who had ≥ 50 copies/mL in the Week 48 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
b Vključuje bolnike, ki so imeli v oknu 48. tedna ≥ 50 kopij/ml; bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka, bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
In a study in virologically suppressed adult patients, improvements in BMD were noted through 96 weeks after switching to Descovy from a TDF containing regimen compared to minimal changes with maintaining the TDF containing regimen as measured by DXA analysis of hip (mean change from baseline of 1.9% vs -0.3%, p < 0.001) and lumbar spine (mean change from baseline of 2.2% vs -0.2%, p < 0.001).
V študiji pri odraslih bolnikih z virološko supresijo so po prehodu na zdravilo Descovy z režima, ki vključuje TDF, po 96 tednih zdravljenja opazili izboljšanje MGK v primerjavi z minimalnimi spremembami pri ohranitvi režima, ki vključuje TDF, izmerjeno z analizo DXA kolka (povprečna sprememba od začetne vrednosti 1,9 % v primerjavi z -0,3 %, p < 0,001) in ledvene hrbtenice (povprečna sprememba od začetne vrednosti 2,2 % v primerjavi z -0,2 %, p < 0,001).
At 48 weeks, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL, similar to response rates in studies of treatment-naïve HIV-1 infected adults.
HIV-1 RNA < 50 kopij/ml, podobno stopnjam odziva v študijah predhodno nezdravljenih odraslih, okuženih s HIV-1.
Lopinavir/ritonavir (800/200 mg once daily), tenofovir alafenamide (10 mg once daily)
lopinavir/ritonavir (800/200 mg enkrat dnevno), tenofoviralafenamid (10 mg enkrat dnevno)
Other HIV antiretrovirals Dolutegravir (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
Druga protiretrovirusna zdravila proti HIV dolutegravir (50 mg enkrat dnevno), tenofoviralafenamid (10 mg enkrat dnevno)3
In studies in treatment-naïve patients, emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat as a fixed-dose combination tablet was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF through 144 weeks of treatment as measured by dual energy X ray absorptiometry (DXA) analysis of hip (mean change: −0.8% vs −3.4%, p < 0.001) and lumbar spine (mean change: −0.9% vs −3.0%, p < 0.001).
Spremembe v meritvah mineralne gostote kosti V študijah pri predhodno nezdravljenih bolnikih je bil emtricitabin + tenofoviralafenamid v kombinaciji z elvitegravirjem + kobicistatomom v obliki tablete s fiksno kombinacijo odmerkov do vključno 144. tedna zdravljenja povezan z manjšimi zmanjšanji mineralne gostote kosti (MGK), ki se je merila z dvoenergijsko rentgensko absorpciometrijsko analizo (DXA) kolka (povprečna sprememba: -0,8 % v primerjavi z -3,4 %, p < 0,001) in ledvene hrbtenice (povprečna sprememba:
There were no new safety issues in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine and tenofovir alafenamide, in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (see section 4.8).
Novih varnostnih vprašanj pri bolnikih s končno ledvično odpovedjo na kronični hemodializi, ki so prejemali emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov, ni bilo (glejte poglavje 4.8).
Descovy 200 mg/10 mg film-coated tablets emtricitabine/tenofovir alafenamide
IME ZDRAVILA Descovy 200 mg/10 mg filmsko obložene tablete emtricitabin/tenofoviralafenamid
In a study in virologically suppressed adult patients, BMD did not change significantly through 48 weeks after switching to Descovy from an abacavir/lamivudine containing regimen compared to maintaining the abacavir/lamivudine containing regimen as measured by DXA analysis of hip (mean change from baseline of 0.3% vs 0.2%, p = 0.55) and lumbar spine (mean change from baseline of 0.1% vs < 0.1%, p = 0.78).
V študiji pri odraslih bolnikih z virološko supresijo se v 48 tednih po prehodu z režima, ki je vseboval abakavir/lamivudin, na zdravilo Descovy, MGK ni bistveno spremenila v primerjavi z ohranitvijo režima, ki je vseboval abakavir/lamivudin, kar je bilo izmerjeno z analizo DXA kolka (povprečna sprememba od izhodiščne vrednosti 0,3 % v primerjavi z 0,2 %, p = 0,55) in ledvene hrbtenice
3 Study conducted with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fixed-dose combination tablet.
3 Študija je bila opravljena z elvitegravirjem/kobicistatom/emtricitabinom/tenofoviralafenamidom s tabletami s fiksno kombinacijo odmerkov.
In clinical studies of 866 treatment-naïve adult patients receiving emtricitabine and tenofovir alafenamide with elvitegravir and cobicistat as the fixeddose combination tablet elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (as fumarate) 10 mg (E/C/F/TAF) through 144 weeks, the most frequently reported adverse reactions were diarrhoea (7%), nausea (11%), and headache (6%).
V kliničnih študijah z 866 predhodno nezdravljenimi odraslimi bolniki, ki so prejemali emtricitabin in tenofoviralafenamid z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov elvitegravirja 150 mg/kobicistata 150 mg/emtricitabina 200 mg/tenofoviralafenamida (v obliki fumarata) 10 mg
angioedema3,4, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon:
angioedem3,4, pruritus, utrikarija4
(M, N, and O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Vrednosti EC50 za tenofoviralafenamid so bile v razponu od 2,0 do 14,7 nM. Tenofoviralafenamid je pokazal protivirusno aktivnost v celični kulturi vseh skupin HIV-1 (M, N in O), vključno s podtipi A, B, C, D, E, F in G (vrednosti EC50 so bile v razponu od 0,10 do 12,0 nM) in je pokazal aktivnost, specifično za sev, proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,91 do 2,63 nM).
 If any of the side effects get serious tell your doctor.
• bolečina v sklepih (artralgija)  Če postane kateri koli od teh neželenih učinkov resen, obvestite svojega zdravnika.
Darunavir/cobicistat (800/150 mg once daily), tenofovir alafenamide (25 mg once daily)5
darunavir/kobicistat (800/150 mg enkrat dnevno), tenofoviralafenamid (25 mg enkrat dnevno)5
No virologic data at Week 48 or 96 window Discontinued study drug due to AE or deathd
≥ 50 kopij/mlc Brez viroloških podatkov v oknu 48. ali 96. tedna
How to store Descovy
Shranjevanje zdravila Descovy
Descovy 200 mg/25 mg film-coated tablets emtricitabine/tenofovir alafenamide
IME ZDRAVILA Descovy 200 mg/25 mg filmsko obložene tablete emtricitabin/tenofoviralafenamid
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine and tenofovir alafenamide, in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (see section 5.2).
Novih vprašanj glede varnosti pri bolnikih s končno ledvično odpovedjo na kronični hemodializi, ki so dobivali emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov, niso prepoznali (glejte poglavje 5.2).
HIV-1 RNA < 50 copies/mL
HIV-1 RNA < 50 kopij/mle
The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825) in which 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina in tenofoviralafenamida so ocenili v 48-tedenski odprti klinični študiji z eno skupino (GS-US-292-1825), v kateri je 55 bolnikov z virološko supresijo z okužbo s HIV-1 in končno ledvično odpovedjo (eGFRCG < 15 ml/min) na kronični hemodializi prejemalo emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
HIV-1 infected virologically suppressed patients
Bolniki z virusno supresijo, okuženi s HIV-1
The recommended dose of Descovy is 200/25 mg once daily.
Descovy je 200/25 mg enkrat dnevno.
Medicinal product by therapeutic areas1
Učinkovine po terapevtskih področjih1
Marketing Authorisation Holder: Gilead Sciences Ireland UC Carrigtohill
Imetnik dovoljenja za promet z zdravilom: Gilead Sciences Ireland UC
Co-administration of rifampicin, rifabutin, and rifapentine, all of which are P-gp inducers, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Sočasno dajanje rifampicina, rifabutina in rifapentina, ki so induktorji P-gp, lahko zmanjša koncentracije tenofoviralafenamida v plazmi, kar ima lahko za posledico izgubo terapevtskega učinka in razvoj rezistence.
No dose adjustment of sofosbuvir, velpatasvir or voxilaprevir is required.
velpatasvirja ali voksilaprevirja ni treba prilagajati.
Polyvinyl alcohol Titanium dioxide Macrogol 3350
Jedro tablete mikrokristalna celuloza premreženi natrijev karmelozat magnezijev stearat Filmska obloga polivinilalkohol titanov dioksid makrogol 3350
Each Descovy film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Ena filmsko obložena tableta zdravila Descovy vsebuje 200 mg emtricitabina in tenofoviralafenamidijevega fumarata v količini, ki ustreza 25 mg tenofoviralafenamida.
Exposures of emtricitabine and tenofovir alafenamide (given with elvitegravir and cobicistat) achieved in 24 paediatric patients aged 12 to < 18 years who received emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat in Study GS-US-292-0106 were similar to exposures achieved in treatment-naïve adults (Table 7).
Izpostavljenosti emtricitabinu in tenofoviralafenamidu (v kombinaciji z elvitegravirom in kobicistatom), ki jih je doseglo 24 pediatričnih bolnikov, starih 12 do < 18 let, ki so prejemali emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirom in kobicistatom v študiji
The safety of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [E/C/F/TAF]) was evaluated in 72 HIV/HBV co-infected patients receiving treatment for HIV in an open-label clinical study (GS-US-292-1249), through Week 48, in which patients were switched from another antiretroviral regimen (which included tenofovir disoproxil fumarate [TDF] in 69 of 72 patients) to E/C/F/TAF.
[E/C/F/TAF]) so ocenili pri 72 bolnikih s hkratno okužbo s HIV/HBV, ki so se trenutno zdravili zaradi HIV v odprti klinični študiji (GS-US-292-1249) do konca 48. tedna, v kateri so bolniki prešli z drugega protiretrovirusnega režima (ki je vključeval dizoproksiltenofovirijev fumarat [TDF] pri 69 od
Each Descovy film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Ena filmsko obložena tableta zdravila Descovy vsebuje 200 mg emtricitabina in tenofoviralafenamidijevega fumarata v količini, ki ustreza 10 mg tenofoviralafenamida.
to 1.5 μM).
0,25 ± 0,11 μg•h/ml.
In a clinical study of HIV virologically suppressed patients co-infected with chronic hepatitis B, who received emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet (E/C/F/TAF), for 48 weeks (GS-US-292-1249, n = 72), 2 patients qualified for resistance analysis.
ki so 48 tednov prejemali emtricitabin in tenofoviralafenamid, uporabljena z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov (E/C/F/TAF) (GS-US-292-1249, n = 72), sta bila 2 bolnika primerna za analizo rezistence.
Anti-hepatitis C virus medicinal products Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Zdravila proti virusu hepatitisa C ledipasvir (90 mg enkrat dnevno)/ sofosbuvir (400 mg enkrat dnevno), emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (10 mg enkrat dnevno)3
Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (25 mg once daily) 4
ledipasvir (90 mg enkrat dnevno)/ sofosbuvir (400 mg enkrat dnevno), emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (25 mg enkrat dnevno)4
Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (E/C/F/TAF) in Study GS-US-292-1825 were significantly higher than in patients with normal renal function.
Izpostavljenosti emtricitabinu in tenofovirju pri 12 bolnikih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi, ki so prejemali emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov
Co-administration of fluconazole or isavuconazole may increase plasma concentrations of tenofovir alafenamide.
ritonavirjem, ciklosporinom), poveča absorpcijo in koncentracijo tenofoviralafenamida v plazmi.
The recommended dose of Descovy is 200/10 mg once daily.
Descovy je 200/10 mg enkrat dnevno.
No dose adjustment of Descovy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
35 kg) z ocenjenim očistkom kreatinina (creatinine clearance, CrCl) ≥ 30 ml/min ni treba prilagoditi.