natgillin/translations-raw huggingface dataset:
The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (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).
No in vitro resistance can be demonstrated with cobicistat due to its lack of antiviral activity.
Zaradi pomanjkanja protivirusne aktivnosti s kobicistatom in vitro ni mogoče dokazati rezistence.
At Week 144, 83.1% (197/237 patients) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya.
V 144. tednu je 83,1 % (197/237 bolnikov) ohranilo HIV-1 RNA < 50 kopij/ml po prehodu na zdravilo Genvoya.
Concentrations of pitavastatin may be increased when administered with elvitegravir and cobicistat.
Koncentracije pitavastatina se lahko pri uporabi z elvitegravirjem in kobicistatom zvišajo.
Caution is warranted and clinical monitoring is recommended during the co-administration.
Med sočasno uporabo je potrebna previdnost, priporoča pa se tudi klinično spremljanje.
ANTIARRHYTHMICS Digoxin (0.5 mg single dose)/ Cobicistat (150 mg multiple doses)
ANTIARITMIKI digoksin (0,5 mg enkratni odmerek)/kobicistat (150 mg večkratni odmerki)
In human clinical studies, a 10 mg oral dose of tenofovir alafenamide in Genvoya 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) in E/C/F/TDF.
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
 If any of these applies to you, talk to your doctor before taking Genvoya.
 Če kar koli od navedenega velja za vas, se pred jemanjem zdravila Genvoya posvetujte z zdravnikom.
Elvitegravir may have the potential to induce CYP2C9 and/or inducible uridine diphosphate glucuronosyltransferase (UGT) enzymes; as such it may decrease the plasma concentration of substrates of these enzymes.
Elvitegravir lahko morda inducira encim CYP2C9 in/ali inducibilne encime uridin difosfat glukuronoziltransferaze (UGT).
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).
In Study GS-US-292-0109, the efficacy and safety of switching from either efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil, FTC/tenofovir disoproxil plus atazanavir (boosted by either cobicistat or ritonavir), or E/C/F/TDF to Genvoya were evaluated in a randomised, open-label study of virologically suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 1,436).
(FTC)/dizoproksiltenofovirata, FTC/dizoproksiltenofovirata in atazanavirja (ojačanega s kobicistatom ali ritonavirjem) ali E/C/F/TDF na zdravilo Genvoya ocenili v randomizirani, odprti študiji pri odraslih z virusno supresijo, okuženih s HIV-1 (HIV-1 RNA < 50 kopij/ml) (n = 1.436).
Steady-state mean Cmax and AUCtau for tenofovir alafenamide were 0.16 ± 0.08 µg/mL and 0.21 ± 0.15 µg•h/mL, respectively.
Povprečni Cmax in AUCtau za tenofoviralafenamid v stanju dinamičnega ravnovesja sta bila 0,16 ± 0,08 µg/ml, oz. 0,21 ± 0,15 µg•h/ml.
Reproductive toxicity studies in rats and rabbits with cobicistat showed no effects on mating, fertility, pregnancy or foetal parameters.
Študije vpliva kobicistata na sposobnost razmnoževanja pri podganah in kuncih niso pokazale učinka na parametre parjenja, plodnosti, nosečnost in plod.
4 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate.
4 Ta študija je bila opravljena z elvitegravirjem/kobicistatom/emtricitabinom/dizoproksiltenofovirijevim fumaratom.
Emtricitabine exposures were unaffected by a light or high-fat meal.
Hrana z nizko ali visoko vsebnostjo maščobe ni vplivala na izpostavljenost emtricitabinu.
Medicinal products that strongly affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption.
BCRP, lahko povzročijo spremembe v absorpciji tenofoviralafenamida.
In patients treated with Genvoya, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL.
92 % (46/50) bolnikov, zdravljenih z zdravilom Genvoya, je doseglo HIV-1 RNA < 50 kopij/ml.
Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets.
IME ZDRAVILA Genvoya 150 mg/150 mg/200 mg/10 mg filmsko obložene tablete
Interaction not studied with any of the components of Genvoya.
Interakcije niso preučili z nobeno od učinkovin zdravila Genvoya.
In a clinical study (GS-US-292-0106) in which Genvoya was administered to 23 HIV-1 infected paediatric patients with a mean age of 10 years (range 8 to 11 years), the mean exposures of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide were higher (20 to 80%) than the mean exposures achieved in adults (see sections 4.1 and 5.2).
V klinični študiji (GS-US-292-0106), v kateri so zdravilo Genvoya dajali 23 pediatričnim bolnikom, okuženim s HIV-1, s povprečno starostjo 10 let (razpon od 8 do 11 let), so bile povprečne izpostavljenosti elvitegravirju, kobicistatu, emtricitabinu, tenofovirju in tenofoviralafenamidu večje
Patients receiving Genvoya or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Pri bolnikih, ki se zdravijo z zdravilom Genvoya ali s katero koli drugo obliko protiretrovirusne terapije, se lahko še naprej razvijajo oportunistične okužbe in drugi zapleti okužbe z virusom HIV.
In Study GS-US-292-1825, the efficacy and safety of Genvoya 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 Genvoya.
V študiji GS-US-292-1825 so učinkovitost in varnost zdravila Genvoya 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 zdravilo Genvoya.
4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products.
4 Ta neželeni učinek je bil opredeljen v okviru nadzora za zdravila, ki vsebujejo tenofoviralafenamid, v obdobju trženja zdravil.
IMMUNOSUPPRESSANTS Ciclosporin
IMUNOSUPRESIVI ciklosporin sirolimus takrolimus
Co-administration with CYP3A-metabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects.
Sočasna uporaba s kortikosteroidi, ki se presnavljajo s pomočjo encimov CYP3A, se ne priporoča, razen kadar možne koristi za bolnika odtehtajo tveganje.
Concentrations of voriconazole may increase or decrease when co-administered with Genvoya.
Koncentracije vorikonazola se lahko pri sočasnem dajanju z zdravilom Genvoya zvišajo ali znižajo.
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.
HBV (HBV DNA ≥ 29 i.e./ml), jih je 7 razvilo supresijo, pri 2 vrednost ni bila zaznavna, pri 1 pa so podatki manjkali.
Intravenously administered midazolam (1 mg single dose)/ Tenofovir alafenamide (25 mg once daily)
Intravenski midazolam (1 mg enkratni odmerek)/tenofoviralafenamid (25 mg enkrat dnevno)
At baseline, median CD4+ cell count was 969 cells/mm3 (range: 603 to 1,421), and median CD4+% was 39% (range: 30 to 51%).
Na začetku je bilo mediano število celic CD4+ 969 celic/mm3 (razpon: 603 do 1.421) in mediana CD4+ % je bila 39 % (razpon: 30 do 51 %).
At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya.
V 48. tednu je 92 % bolnikov (66/72) ohranilo HIV-1 RNA < 50 kopij/ml po prehodu na zdravilo Genvoya.
At baseline, median CD4+ cell count was 742 cells/mm3 (range: 255 to 1,246) and median CD4+% was 34% (range: 21 to 53%).
Ob izhodišču je bila mediana števila celic CD4+ 742 celic/mm3 (razpon: od 255 do 1246) in mediana CD4+ % je bila 34 % (razpon: od 21 do 53 %).
Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
V običajnih testih genotoksičnosti tenofoviralafenamid ni bil mutagen ali klastogen.
• tenofovir alafenamide, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI)
• tenofoviralafenamid, protiretrovirusno zdravilo, znano kot zaviralec nukleotidne reverzne transkriptaze (NtRTI- nucleotide reverse transcriptase inhibitor)
Mean increases from baseline in the Genvoya group were smaller than in the elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) group at Week 144 (difference -0.04, p < 0.001).
Povprečno povečanje od začetne vrednosti v skupini z zdravilom Genvoya je bilo po 144 tednih manjše kot v skupini z elvitegravirjem 150 mg/kobicistatom 150 mg/emtricitabinom 200 mg/dizoproksiltenofoviratom (v obliki fumarata) 245 mg (E/C/F/TDF)
The safety of Genvoya in 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) was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112).
(n = 6) ali z virusno supresijo (n = 242), z blago do zmerno ledvično okvaro (ocenjena hitrost glomerularne filtracije po metodi Cockcroft-Gault [eGFRCG]: 30-69 ml/min) je bila ocenjena do konca 144. tedna v odprti klinični študiji (GS-US-292-0112).
Due to the presence of cobicistat, co-administration with Genvoya may result in increased plasma concentrations of this medicinal product, which is associated with the potential for serious or life-threatening adverse reactions.
Zaradi prisotnosti kobicistata lahko sočasno dajanje z zdravilom Genvoya povzroči zvišanje koncentracij tega zdravila v plazmi, kar je povezano z možnimi resnimi ali življenjsko nevarnimi neželenimi učinki.
No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between patients with moderate hepatic impairment and subjects with normal hepatic function.
Klinično pomembnih razlik v farmakokinetičnih lastnostih elvitegravirja ali kobicistata med bolniki z zmerno jetrno okvaro in preskušanci z normalnim delovanjem jeter niso opazili.
PDE-5 inhibitors are primarily metabolised by CYP3A.
Zaviralci PDE-5 se presnavljajo pretežno s CYP3A.
Indigo carmine aluminium lake (E132) Iron oxide yellow (E172)
smukec (E553b) indigotin (E132) rumeni železov oksid (E172)
No dose adjustment of Genvoya is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Genvoya 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 Genvoya pri odraslih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi ni treba prilagoditi; vendar pa se je treba zdravilu Genvoya načeloma izogniti, a se lahko uporablja pri teh bolnikih, če prevlada mnenje, da so možne koristi večje od možnih tveganj
• emtricitabine, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor
• emtricitabin, protiretrovirusno zdravilo, znano kot zaviralec nukleozidne reverzne transkriptaze
The mean baseline CD4+ cell count was 697 cells/mm3 (range 79-1,951).
Povprečno število celic CD4+ na začetku je bilo 697 celic/mm3 (razpon 79-1.951).
It is not known whether elvitegravir, cobicistat, or tenofovir alafenamide are excreted in human milk.
Ni znano, ali se emtricitabin, kobicistat ali tenofoviralafenamid izločajo v materino mleko.
Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product.
Sočasno dajanje z zdravilom Genvoya lahko povzroči zvišanje koncentracij tega zdravila v plazmi.
The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1,498).
Povprečno število celic CD4+ ob izhodišču je bilo 636 celic/mm3 (razpon 263-1.498).
Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
HIV-1, HIV-2 in HBV. Tenofoviralafenamid je nukleotidni zaviralec reverzne transkriptaze (NtRTI- nucleotide reverse transcriptase inhibitor) in fosfonamidatno predzdravilo tenofovirja (analog 2'-deoksiadenozin monofosfata).
If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
150 mg trikrat tedensko na določene dni (na primer ponedeljek-sreda-petek).
In studies in treatment-naïve patients, Genvoya was associated with a lower impact on renal safety parameters (as measured after 144 weeks treatment by estimated glomerular filtration rate by
V študijah pri predhodno nezdravljenih bolnikih je bilo zdravilo Genvoya po 144 tednih zdravljenja povezano z manjšim zmanjšanjem mineralne gostote kosti (MGK), ki se je merila z analizo DXA
In a pooled analysis, genotyping was performed on plasma HIV-1 isolates from antiretroviral-naïve patients receiving Genvoya in Phase 3 studies GS-US-292-0104 and GS-US-292-0111 with HIV-1 RNA ≥ 400 copies/mL at confirmed virologic failure, Week 144, or time of early study drug discontinuation.
GS-US-292-0104 in GS-US-292-0111, s HIV-1 RNA ≥ 400 kopij/ml s potrjenim virološkim neuspehom, v 144. tednu ali v času predčasne prekinitve študijskega zdravila.
Seventy-nine percent were male, 63% were White, 18% were
Devetinsedemdeset odstotkov je bilo moških, 63 % je bilo belcev, 18 % je bilo črncev in 14 % je bilo
In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of Genvoya were evaluated in an open-label study in HIV-1 infected, treatment-naïve adolescents between the ages of 12 to < 18 years, weighing ≥ 35 kg (n = 50) in Cohort 1, and in virologically suppressed children between the ages of 8 to < 12 years, weighing > 25 kg (n = 23) in Cohort 2.
V študiji GS-US-292-0106 so ocenili učinkovitost, varnost in farmakokinetiko zdravila Genvoya v odprti študiji s predhodno nezdravljenimi mladostniki, okuženimi s HIV-1, starimi od 12 do < 18 let, s telesno maso ≥ 35 kg (n = 50) v kohorti 1 in pri otrocih z virološko supresijo, starimi od 8 do < 12 let,
Co-administration with dabigatran etexilate, a P-glycoprotein (P-gp) substrate, is contraindicated (see section 4.5).
Sočasno dajanje z dabigatran eteksilatom, substratom P-glikoproteina (P-gp), je kontraindicirano
At baseline, mean plasma HIV-1 RNA was 4.6 log10 copies/mL, median CD4+ cell count was 456 cells/mm3 (range: 95 to 1,110), and median CD4+% was 23% (range: 7 to 45%).
Na začetku je bila povprečna plazemska HIV-1 RNA 4,6 log10 kopij/ml, mediano število celic CD4+ je bilo 456 celic/mm3 (razpon: 95 do 1.110) in mediana CD4+ % je bila
At Week 48, 81.8% (45/55 patients) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya.
V 48. tednu je 81,8 % (45/55 bolnikov) ohranilo vrednost HIV-1 RNA < 50 kopij/ml po prehodu na zdravilo Genvoya.
1 When data available from drug-drug interaction studies.
DOAC = neposredni peroralni antikoagulant 1 Ko so razpoložljivi podatki iz študij medsebojnega delovanja zdravil.
The safety profile of Genvoya in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Varnostni profil zdravila Genvoya pri bolnikih z blago do zmerno ledvično okvaro je bil podoben kot pri bolnikih z normalnim delovanjem ledvic
HIV-1 isolates with the K65R mutation have low-level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Poleg tega so prehodno opazili mutacijo K70E v HIV-1 RT. Izolati HIV-1 z mutacijo K65R imajo zmanjšano občutljivost za abakavir, emtricitabin, tenofovir in lamivudin.
Table 5: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Preglednica 5: Farmakokinetika elvitegravirja, kobicistata, emtricitabina, tenofovirja in tenofoviralafenamida pri mladostnikih in odraslih, ki se predhodno niso zdravili s protiretrovirusnimi zdravili
• PDE-5 inhibitors: sildenafil for the treatment of pulmonary arterial hypertension
• zaviralci PDE-5: sildenafil za zdravljenje pljučne arterijske hipertenzije • sedativi/hipnotiki: peroralno uporabljeni midazolam, triazolam
ANTI-GOUT Colchicine
ZDRAVILA PROTI PROTINU kolhicin
4.2% (95% CI: 0.6% to 7.8%)
4,2 % (95-% IZ: 0,6 % do 7,8 %)
Based on non-CYP-mediated elimination pathways for lorazepam, no effect on plasma concentrations is expected upon co-administration with Genvoya.
se po sočasni uporabi z zdravilom Genvoya ne pričakuje učinka na koncentracije v plazmi.
Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with Genvoya.
MATE1 in koncentracije metformina se lahko pri sočasnem dajanju z zdravilom Genvoya zvišajo.
Concentrations of these antiarrhythmic drugs may be increased when co-administered with cobicistat.
Koncentracije teh antiaritmikov se lahko pri sočasni uporabi s kobicistatom zvišajo.
HIV-1 RNA < 20 copies/mL Treatment difference
HIV-1 RNA < 20 kopij/ml Razlika zdravljenja
ORAL CONTRACEPTIVES Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/ Cobicistat (150 mg once daily)
PERORALNI KONTRACEPTIVI drospirenon/etinilestradiol (3 mg/0,02 mg enkratni odmerek)/kobicistat (150 mg enkrat dnevno)
Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
IME ZDRAVILA Genvoya 150 mg/150 mg/200 mg/10 mg filmsko obložene tablete elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid
Treatment with cobicistat and elvitegravir during the second and third trimesters of pregnancy has been shown to result in lower elvitegravir exposure (see section 5.2).
Dokazano je bilo, da ima zdravljenje s kobicistatom in elvitegravirjem med drugim in tretjim trimestrom nosečnosti za posledico manjše izpostavljenosti elvitegravirju (glejte poglavje 5.2).
betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
• kortikosteroide, vključno z: betametazonom, budezonidom, flutikazonom, mometazonom, prednizonom,
Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product, which is associated with the potential for serious or life-threatening adverse reactions.
Sočasno dajanje z zdravilom Genvoya lahko povzroči zvišanje koncentracij tega zdravila v plazmi, kar je povezano z možnimi resnimi ali življenjsko nevarnimi neželenimi učinki.
The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Učinkovine so elvitegravir, kobicistat, emtricitabin in tenofoviralafenamid.
Reduced susceptibility to emtricitabine is associated with M184V/I mutations in HIV-1 RT.
Zmanjšana občutljivost za emtricitabin je povezana z mutacijami M184V/I pri HIV-1 RT. Izolati HIV-1 z zmanjšano občutljivostjo za tenofoviralafenamid izražajo mutacijo K65R v HIV-1 RT.
The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells/mm3.
Povprečno zvišanje števila celic CD4+ god začetka v 48. tednu je bilo 224 celic/mm3.
Co-administration of Genvoya with carbamazepine is contraindicated (see section 4.3).
Sočasno dajanje zdravila Genvoya s karbamazepinom je kontraindicirano (glejte poglavje 4.3).
Concentrations of ketoconazole and/or cobicistat may increase with co-administration of Genvoya.
Koncentracije ketokonazola in/ali kobicistata se lahko pri sočasnem dajanju zdravila Genvoya zvišajo.
Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinyloestradiol (0.025 mg once daily)/ Emtricitabine/Tenofovir alafenamide (200/25 mg once daily)6
norgestimat (0,180/0,215/0,250 mg enkrat dnevno)/etinilestradiol (0,025 mg enkrat dnevno)/emtricitabin/ tenofoviralafenamid (200/25 mg enkrat dnevno)6
Contents of the pack and other information
Shranjevanje zdravila Genvoya Vsebina pakiranja in dodatne informacije
Therefore, therapy with Genvoya should not be initiated during pregnancy, and women who become pregnant during therapy with Genvoya should be switched to an alternative regimen (see sections 4.2 and 4.6).
Zato se zdravljenje z zdravilom Genvoya ne sme uvesti med nosečnostjo; ženske, ki med zdravljenjem z zdravilom Genvoya zanosijo, pa morajo preiti na drug režim (glejte poglavji 4.2 in 4.6).
Therefore, therapy with Genvoya should not be initiated during pregnancy, and women who become pregnant during therapy with Genvoya should be switched to an alternative regimen (see sections 4.4 and 4.6).
Zato se zdravljenje z zdravilom Genvoya ne sme uvesti med nosečnostjo; ženske, ki med zdravljenjem z zdravilom Genvoya zanosijo, pa morajo preiti na drug režim (glejte poglavji 4.4 in 4.6).
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravila Genvoya se ne sme dajati sočasno z drugimi protiretrovirusnimi zdravili.
HIV-1 infected, treatment-naïve patients
Predhodno nezdravljeni bolniki, okuženi s HIV-1
The mean baseline CD4+ cell count was 545 cells/mm3 (range 205-1473).
545 celic/mm3 (razpon 205-1473).
• abnormal dreams
• nenavadne sanje • glavobol
Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL Baseline CD4+ cell count < 200 cells/mm3 ≥ 200 cells/mm3
≤ 100.000 kopij/ml > 100.000 kopij/ml
FTC/tenofovir disoproxil plus boosted atazanavir E/C/F/TDF
EFV/FTC/dizoproksiltenofovirat FTC/dizoproksiltenofovirat z ojačanim atazanavirjem
• adefovir dipivoxil
• dizoproksiltenofovirat
Cockcroft-Gault method, and urine protein to creatinine ratio and after 96 weeks treatment by urine albumin to creatinine ratio) compared to E/C/F/TDF (see also section 4.4).
Spremembe v meritvah delovanja ledvic V študijah pri predhodno nezdravljenih bolnikih je bilo zdravilo Genvoya povezano z manjšim vplivom na parametre varnosti za ledvice (izmerjene po 144 tednih zdravljenja z ocenjeno hitrostjo glomerularne filtracije po metodi Cockcroft-Gault ter razmerjem med beljakovinami ter kreatininom v urinu in po 96 tednih zdravljenja z razmerjem albumina ter kreatinina v urinu) kot E/C/F/TDF (glejte tudi poglavje 4.4).
How to store Genvoya
Shranjevanje zdravila Genvoya
Concentrations of clarithromycin and/or cobicistat may be altered with co-administration of Genvoya.
Koncentracije klaritromicina in/ali kobicistata se lahko pri sočasnem dajanju zdravila Genvoya spremenijo.
The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in Genvoya-treated patients and 211 cells/mm3 in E/C/F/TDF-treated patients (p = 0.024) at Week 48, and 326 cells/mm3 in Genvoya-treated patients and 305 cells/mm3 in E/C/F/TDF-treated patients (p = 0.06) at Week 144.
v 144. tednu pa 326 celic/mm3 pri bolnikih, zdravljenih z zdravilom Genvoya, in 305 celic/mm3 pri bolnikih, zdravljenih z E/C/F/TDF (p = 0,06).
It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Genvoya.
Pri sočasnem dajanju zdravila Genvoya se priporoča spremljanje mednarodnega normaliziranega razmerja (INR- International Normalised Ratio).