natgillin/translations-raw huggingface dataset:
At the start of treatment with E/C/F/TAF, the 72 patients had been HIV-suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
Na začetku zdravljenja z E/C/F/TAF je imelo 72 bolnikov vsaj 6 mesecev supresijo HIV (HIV-1 RNA < 50 kopij/ml) s supresijo HBV DNA ali brez nje in kompenzirano jetrno funkcijo.
There were no clinically significant changes in fasting lipid laboratory tests in patients who switched.
Klinično pomembnih sprememb v laboratorijskih preiskavah lipidov na tešče pri bolnikih, ki so zdravilo zamenjali, ni bilo.
Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL
≤ 100.000 kopij/ml > 100.000 kopij/ml
Other protease inhibitors
Drugi zaviralci proteaze
In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl < 30 mL/min) (33.7 μg•h/mL) than in subjects with normal renal function (11.8 μg•h/mL).
V ločeni študiji 1. faze samo z emtricitabinom je bila povprečna sistemska izpostavljenost emtricitabinu večja pri bolnikih s hudo okvaro ledvic (ocenjeni CrCL < 30 ml/min) (33,7 µg•h/ml) kot pri preskušancih z normalnim delovanjem ledvic (11,8 µg•h/ml).
Emtricitabine did not inhibit the glucuronidation reaction of a non-specific UGT substrate in vitro.
Emtricitabin in vitro ni zaviral glukuronidacijske reakcije na nespecifične substrate UGT.
If a patient misses a dose of Descovy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Če bolnik izpusti odmerek zdravila Descovy za več kot 18 ur, naj ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 μg/mL.
In vitro je bila vezava tenofovirata na humane plazemske proteine < 0,7 % in je neodvisna od koncentracije v razponu med 0,01-25 μg/ml.
Descovy in combination with other medicines is for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and adolescents 12 years of age and older, who weigh at least 35 kg.
Zdravilo Descovy v kombinaciji z drugimi zdravili je namenjeno zdravljenju okužbe z virusom človeške imunske pomanjkljivosti 1 (HIV-1) pri odraslih in mladostnikih, starih 12 let in več, s telesno maso vsaj 35 kg.
Multinucleoside-resistant HIV-1 with a T69S double insertion mutation or with a Q151M mutation complex including K65R showed reduced susceptibility to tenofovir alafenamide.
Proti multinukleozidu rezistenten HIV-1 z dvojno insercijsko mutacijo T69S ali mutacijskim kompleksom Q151M, vključno s K65R, je pokazal zmanjšano občutljivost za tenofoviralafenamid.
No dose adjustment of Descovy is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Descovy should generally be avoided but may be used in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2).
Odmerka zdravila Descovy pri odraslih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi ni treba prilagoditi; vendar pa se je treba zdravilu Descovy načeloma izogniti, a se lahko uporablja pri teh bolnikih, če prevlada mnenje, da so možne koristi večje od možnih tveganj (glejte poglavji 4.4 in 5.2).
< 20 copies/mL
< 50 kopij/ml
emtricitabine and tipranavir
- emtricitabin in tipranavir
Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil fumarate in concentrating tenofovir in peripheral blood mononuclear cells (PBMCs) or HIV target cells including lymphocytes and macrophages.
Tenofoviralafenamid prodira v celice in zaradi večje stabilnosti v plazmi in aktivacije v celici s hidrolizo s pomočjo katepsina A je tenofoviralafenamid bolj učinkovit kot dizoproksiltenofovirijev fumarat pri koncentriranju tenofovirja v mononuklearnih celicah v periferni krvi (peripheral blood mononuclear cells, PBMC) ali drugih ciljnih celicah HIV, vključno z limfociti in makrofagi.
Do not stop taking Descovy without talking to your doctor.
Ne prenehajte jemati zdravila Descovy, ne da bi se posvetovali z zdravnikom.
Hepatic impairment No dose adjustment of Descovy is required in patients with hepatic impairment.
Odmerka zdravila Descovy ni treba prilagoditi pri bolnikih z jetrno okvaro.
In animal studies there were no effects of emtricitabine and tenofovir alafenamide on mating or fertility parameters (see section 5.3).
V študijah na živalih ni bilo učinkov emtricitabina ali tenofoviralafenamida na parjenje ali parametre plodnosti (glejte poglavje 5.3).
Tenofovir alafenamide is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Tenofoviralafenamid se prenaša s P-glikoproteinom (P-gp) in proteinom, odpornim na raka dojke (BCRP, Breast Cancer Resistance Protein).
If you take more than the recommended dose of Descovy you may be at higher risk of side effects of this medicine (see section 4, Possible side effects).
Če ste vzeli večji odmerek zdravila Descovy, kot bi smeli Če ste zaužili odmerek zdravila Descovy, višji od priporočenega, obstaja večje tveganje za neželene učinke (glejte poglavje 4, Možni neželeni učinki).
At baseline, 30% of patients were receiving abacavir/lamivudine in combination with a boosted protease inhibitor and 70% of patients were receiving abacavir/lamivudine in combination with an unboosted third agent.
Ob izhodišču je 30 % bolnikov prejemalo abakavir/lamivudin v kombinaciji z okrepljenim zaviralcem proteaze, 70 % bolnikov pa abakavir/lamivudin v kombinaciji z neokrepljenim tretjim zdravilom.
Fluconazole Isavuconazole
flukonazol izavukonazol
Descovy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine or adefovir dipivoxil.
Zdravila Descovy se ne sme dajati skupaj z zdravili, ki vsebujejo tenofoviralafenamid, dizoproksiltenofovirat, emtricitabin, lamivudin ali dipivoksiladefovirat.
Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Tenofovir se izloča preko ledvic s pomočjo glomerularne filtracije in aktivnega tubularnega izločanja.
Descovy should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Zdravilu Descovy se je treba izogibati pri bolnikih, ki so se že zdravili s protiretrovirusnimi zdravili in imajo virus HIV-1, ki je nosilec mutacije K65R (glejte poglavje 5.1).
Indigo carmine aluminium lake (E132)
smukec indigotin (E132)
What Descovy looks like and contents of the pack
Izgled zdravila Descovy in vsebina pakiranja
Patients were randomised in a 1:1 ratio to either switch to Descovy (n = 333), or stay on their baseline emtricitabine/tenofovir disoproxil fumarate containing regimen (n = 330).
Bolniki so bili randomizirani v razmerju 1:1 bodisi za prehod na zdravilo Descovy (n = 333) ali za nadaljevanje začetnega režima, ki je vseboval emtricitabin/dizoproksiltenofovirijev fumarat (n = 330).
The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3.
Na porazdelitev tenofoviralafenamida v telesu lahko vplivata dejavnost OATP1B1 in
Of the 10 patients who were not HBV suppressed at baseline (HBV DNA ≥ 29 IU/mL), 7 became suppressed, 2 remained detectable, and 1 had missing data.
Med 10 bolniki, ki ob izhodišču niso imeli supresije HBV (HBV DNA ≥ 29 i.e./ml), jih je 7 razvilo supresijo, pri 2 vrednost ni bila zaznavna, pri 1 pa so podatki manjkali.
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 Descovy.
Toksičen vpliv na kosti so opazili kot zmanjšano MGK pri podganah in psih pri izpostavljenostih tenofovirju, ki so bile vsaj štirikrat večje kot izpostavljenost, pričakovana pri dajanju zdravila Descovy.
Male Female
Ženski
If the patient vomits within 1 hour of taking Descovy another tablet should be taken.
Če bolnik v roku 1 ure od jemanja zdravila Descovy bruha, naj vzame drugo tableto.
In a study in virologically suppressed adult patients measures of tubular proteinuria were similar in patients switching to a regimen containing Descovy compared to patients who stayed on an abacavir/lamivudine containing regimen at baseline.
V študiji pri odraslih bolnikih z virološko supresijo so bile meritve tubulne proteinurije podobne pri bolnikih, ki so prešli na režim, ki je vseboval zdravilo Descovy in bolnikih, ki so nadaljevali z začetnim režimom, ki je vseboval abakavir/lamivudin.
Descovy should generally be avoided but may be used in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Zdravilu Descovy se je treba načeloma izogniti, a se lahko uporablja pri odraslih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi, če so možne koristi večje od možnih tveganj (glejte poglavje 4.2).
Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching.
Bolniki so imeli virološko supresijo (HIV-1 RNA < 50 kopij/ml) vsaj 6 mesecev pred prehodom.
There are no data on fertility from the use of Descovy in humans.
Podatkov o učinkih uporabe zdravila Descovy na sposobnost razmnoževanja pri ljudeh ni.
The safety profile of emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat in 50 adolescent patients was similar to that in adults (see section 5.1).
Varnostni profil emtricitabina in tenofoviralafenamida v kombinaciji z elvitegravirjem in kobicistatom pri 50 mladostnikih je bil podoben kot pri odraslih (glejte poglavje 5.1).
There are no efficacy and safety studies conducted in treatment-naïve patients with Descovy.
Študij učinkovitosti in varnosti predhodno nezdravljenih bolnikov z zdravilom Descovy niso opravili.
The median (Q1, Q3) change from baseline in total cholesterol to HDL-cholesterol ratio at Week 144 was 0.2 (-0.3, 0.7) in the E/C/F/TAF group and 0.1 (-0.4, 0.6) in the E/C/F/TDF group (p = 0.006 for the difference between treatment groups).
Mediana (Q1, Q3) sprememba od začetne vrednosti za razmerje med skupnim holesterolom in HDL holesterolom v 144. tednu je bila 0,2 (-0,3; 0,7) v skupini z zdravilom E/C/F/TAF in 0,1 (-0,4; 0,6) v skupini z E/C/F/TDF (p = 0,006 za razliko med skupinama zdravljenja).
Tenofovir alafenamide exposure is not expected to be affected by maraviroc, nevirapine or raltegravir, nor is it expected to affect the metabolic and excretion pathways relevant to maraviroc, nevirapine or raltegravir.
Ne pričakuje se, da bi izpostavljenost tenofoviralafenamidu vplivala na maravirok, nevirapin ali raltegravir ter presnovo in poti izločanja,
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 predstavlja > 80 % peroralnega odmerka.
Co-administration of Descovy and rifabutin rifampicin, or rifapentine is not recommended.
Sočasno dajanje zdravila Descovy in rifabutina, rifampicina ali rifapentina se ne priporoča.
At baseline, 46% of patients were receiving emtricitabine/tenofovir disoproxil fumarate in combination with a boosted PI and 54% of patients were receiving emtricitabine/tenofovir disoproxil fumarate in combination with an unboosted third agent.
Na začetku je 46 % bolnikov prejemalo emtricitabin/dizoproksiltenofovirijev fumarat v kombinaciji z okrepljenim PI, 54 % bolnikov pa emtricitabin/dizoproksiltenofovirijev fumarat v kombinaciji z neokrepljeno tretjo učinkovino.
1 With the exception of angioedema, anaemia and urticaria (see footnotes 2, 3 and 4), all adverse reactions were identified from clinical studies of F/TAF containing products.
1 Z izjemo angioedema, anemije in utrikarije (glejte opombe 2, 3 in 4) so vse neželene učinke ugotovili v kliničnih študijah z zdravili, ki vsebujejo F/TAF.
Emtricitabine has activity against HIV-1, HIV-2, and HBV.
Emtricitabin je aktiven proti HIV-1, HIV-2 in HBV.
Descovy should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Zdravljenje z zdravilom Descovy je treba prekiniti pri bolnikih z ocenjenim CrCl, ki med zdravljenjem pade pod 30 ml/min (glejte poglavje 5.2).
The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in patients receiving E/C/F/TAF and 211 cells/mm3 in patients receiving E/C/F/TDF (p = 0.024) at Week 48, and 326 cells/mm3 in E/C/F/TAF-treated patients and 305 cells/mm3 in E/C/F/TDF-treated patients (p = 0.06) at Week 144.
Povprečno povečanje od začetnega števila celic CD4+ je bilo 230 celic/mm3 pri bolnikih, ki so prejemali E/C/F/TAF, in 211 celic/mm3 pri bolnikih, ki so prejemali E/C/F/TDF (p = 0,024), v 48. tednu, in 326 celic/mm3 pri bolnikih, ki so bili zdravljeni z E/C/F/TAF, in 305 celic/mm3 pri bolnikih, ki so bili zdravljeni z E/C/F/TDF (p = 0,06), v 144. tednu.
Table 7: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Preglednica 7: Farmakokinetika emtricitabina in tenofoviralafenamida pri mladostnikih in odraslih, ki se predhodno niso zdravili s protiretrovirusnimi zdravili
Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 μM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 μM).
Emtricitabin je pokazal protivirusno aktivnost v celični kulturi proti podtipom A, B, C, D, E, F, in G virusa HIV-1 (vrednosti EC50 so bile v razponu od 0,007 do 0,075 µM) in aktivnost, specifično za sev, proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,007 do 1,5 µM).
Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide black (E172).
Filmska obloga: Polivinil alkohol, titanov dioksid, makrogol 3350, smukec, črni železov oksid (E172).
Table 5: Virological outcomes of Study GS-US-299-0102 at Week 24 and 48a
Preglednica 5: Virološki izidi študije GS-US-299-0102 v 24. in 48. tednua
• If you are allergic to emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
• Če ste alergični na emtricitabin, tenofoviralafenamid ali katero koli sestavino tega zdravila
Because there is a lower tenofovir exposure in rats and mice after the administration of tenofovir alafenamide compared to tenofovir disoproxil fumarate, carcinogenicity studies and a rat peripostnatal 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.
1 With the exception of angioedema, anaemia and urticaria (see footnotes 2,3 and 4), all adverse reactions were identified from clinical studies of F/TAF containing products.
1 Z izjemo angioedema, anemije in urtikarije (glejte opombe 2. 3 in 4) so vse neželene učinke ugotovili v kliničnih študijah z zdravili, ki vsebujejo F/TAF.
Studies of tenofovir alafenamide in animals have shown no evidence of harmful effects on fertility parameters, pregnancy, or foetal development (see section 5.3).
Študije tenofoviralafenamida na živalih niso pokazale škodljivih učinkov na parametre plodnosti, nosečnost ali razvoj plodu (glejte poglavje 5.3).
ANTI-INFECTIVES Antifungals Ketoconazole Itraconazole
Antimikotiki ketokonazol itrakonazol
In the E/C/F/TAF group, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), and N155H (n = 2) in integrase.
V skupini z zdravilom E/C/F/TAF so se pojavile mutacije M184V/I (n = 11) in K65R/N (n = 2) v RT ter T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) in N155H (n = 2) v integrazi.
If the patient misses a dose of Descovy within 18 hours of the time it is usually taken, the patient should take Descovy as soon as possible and resume the normal dosing schedule.
Če bolnik izpusti odmerek zdravila Descovy v roku 18 ur od časa, ko ga običajno vzame, naj vzame zdravilo Descovy takoj, ko je mogoče, nato pa nadaljuje z običajnim režimom odmerjanja.
In human clinical studies, a 10 mg oral dose of tenofovir alafenamide (given with emtricitabine and elvitegravir and cobicistat) resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 245 mg oral dose of tenofovir disoproxil (as fumarate) (given with emtricitabine and elvitegravir and cobicistat).
V kliničnih študijah pri ljudeh je 10 mg peroralni odmerek tenofoviralafenamida (v kombinaciji z emtricitabinom in elvitegravirjem in kobicistatom) v PBMC povzročil > 4-krat višje koncentracije tenofovir difosfata in > 90 % nižje koncentracije tenofovirja v plazmi v primerjavi z 245 mg peroralnim odmerkom dizoproksiltenofovirata (v obliki fumarata) (v kombinaciji z emtricitabinom in elvitegravirjem in kobicistatom).
• Autoimmune disorders (the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection.
• Po začetku jemanja zdravil za okužbo s HIV se lahko pojavijo tudi avtoimunske bolezni (imunski sistem napada zdravo telesno tkivo).
Talk to your doctor before taking Descovy: • If you have liver problems or have suffered liver disease, including hepatitis.
• Če imate težave z jetri ali ste imeli jetrne bolezni, vključno s hepatitisom.
When your supply of Descovy starts to run low, get more from your doctor or pharmacist.
Ko se vaše zaloge zdravila Descovy manjšajo, si ga priskrbite pri svojem zdravniku ali farmacevtu.
Patients must have been stably suppressed (HIV-1 RNA < 50 copies/mL) on their baseline regimen for at least 6 months and had HIV-1 with no resistance mutations to emtricitabine or tenofovir alafenamide prior to study entry.
Bolniki so morali biti pred vstopom v študijo stabilno supresirani (HIV-1 RNA < 50 kopij/ml) na začetnem režimu vsaj 6 mesecev in imeti HIV-1 brez mutacij, povezanih z rezistencami proti emtricitabinu ali tenofoviralafenamidu.
The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells/mm3.
Povprečno zvišanje števila celic CD4+ od začetka v 48. tednu je bilo 224 celic/mm3.
Of the 62 patients who were HBV suppressed at baseline, 59 remained suppressed and
Med 62 bolniki, ki so imeli ob izhodišču supresijo HBV, je 59 ohranilo supresijo, za 3 pa so podatki manjkali.
Cross-resistance in HIV-1 infected, treatment-naïve or virologically suppressed patients Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Virusi, rezistentni na emtricitabin, s substitucijo M184V/I, so bili navzkrižno rezistentni na lamivudin, vendar so ohranili občutljivost za didanozin, stavudin, tenofovir in zidovudin.
Tablet core: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Mikrokristalna celuloza, premreženi natrijev karmelozat, magnezijev stearat.
Triple nucleoside therapy
Trojno nukleozidno zdravljenje
Emtricitabine triphosphate inhibits HIV replication through incorporation into viral deoxyribonucleic acid (DNA) by the HIV reverse transcriptase (RT), which results in DNA chaintermination.
Emtricitabin trifosfat zavira podvajanje HIV z vgraditvijo v virusno deoksiribonukleinsko kislino (deoxyribonucleic acid, DNA) z reverzno transkriptazo (RT) HIV, kar povzroči prekinitev verige DNA.
The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells and CD4+-T lymphocytes.
Protivirusna aktivnost tenofoviralafenamida proti laboratorijskim in kliničnim izolatom virusa HIV-1 podtipa B je bila ocenjena v limfoblastoidnih celičnih linijah, PBMC, primarnih monocitnih/makrofagnih celicah in limfocitih CD4+-T.
Patients with HIV-1 harbouring mutations
Bolniki z virusom HIV-1, ki je nosilec mutacij
≥ 200 cells/mm3
< 200 celic/mm3 ≥ 200 celic/mm3
c Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
c Vključuje bolnike, ki so prenehali sodelovati zaradi neželenih učinkov ali smrti, kadar koli od 1. dne do časovnega okna, če zaradi tega v določenem oknu ni bilo viroloških podatkov o zdravljenju.
D/C/F/TAF = darunavir/cobicistat/emtricitabine/tenofovir alafenamide a Week 48 window was between Day 294 and 377 (inclusive).
D/C/F/TAF = darunavir/kobicistat/emtricitabin/tenofoviralafenamid a Okno v 48. tednu je med 294. in 377. dnevom (vključno z njima).
It is not known whether tenofovir alafenamide is excreted in human milk.
Ni znano, ali se tenofoviralafenamid izloča v materino mleko.
No antagonism was observed with emtricitabine or tenofovir alafenamide when combined with other antiretroviral agents.
Antagonizma z emtricitabinom ali tenofoviralafenamidom v kombinaciji z drugimi protiretrovirusnimi zdravili niso opazili.
Co-administration of ketoconazole or itraconazole, which are potent P-gp inhibitors, is expected to increase plasma concentrations of tenofovir alafenamide.
Pričakuje se, da bo sočasno dajanje ketokonazola ali itrakonazola, ki sta močna zaviralca P-gp, povečalo koncentracije tenofoviralafenamida v plazmi.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 μg/mL.
In vitro je bila vezava emtricitabina na humane plazemske proteine manj kot 4 % in je neodvisna od koncentracije v razponu med 0,02-200 µg/ml.
Table 4: Pooled virological outcomes of Studies GS-US-292-0104 and GS-US-292-0111 at Weeks 48 and 144a,b
Preglednica 4: Združeni virološki izidi študij GS-US-292-0104 in GS-US-292-0111 v 48. in 144. tednua,b
Based on these limited data, the safety profile of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet, in patients with HIV/HBV co-infection, was similar to that in patients with HIV-1 monoinfection (see section 4.4).
Na podlagi teh omejenih podatkov je bil varnostni profil emtricitabina in tenofoviralafenamida v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov,pri bolnikih s sočasno okužbo s HIV/HBV podoben kot pri bolnikih z okužbo samo s HIV-1 (glejte poglavje 4.4).
The co-administration of Descovy is not recommended with certain anticonvulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g., rifampicin, rifabutin, rifapentine), St. John's wort and HIV protease inhibitors (PIs) other than atazanavir, lopinavir and darunavir (see section 4.5).
Sočasna uporaba zdravila Descovy z nekaterimi antikonvulzivi (npr. karbamazepinom, okskarbazepinom, fenobarbitalom in fenitoinom), zdravili za zdravljenje okužb z mikobakterijami (npr. rifampicinom, rifabutinom, rifapentinom), šentjanževko in zaviralci proteaze [protease inhibitors, PI] HIV, razen z atazanavirjem, lopinavirjem in darunavirjem (glejte poglavje 4.5) ni priporočljiva.
1 Descovy 200/10 mg in combination with darunavir 800 mg and cobicistat 150 mg, administered as a fixed-dose combination tablet, was studied in treatment-naive subjects, see section 5.1.
1 Zdravilo Descovy 200/10 mg v kombinaciji z darunavirjem 800 mg in kobicistatom 150 mg, dano kot tableta s fiksno kombinacijo odmerkov, so preučili pri predhodno nezdravljenih osebah, glejte poglavje 5.1.