natgillin/translations-raw huggingface dataset:
In a study of virologically suppressed patients switching from EFV/FTC/TDF to Odefsey (Study GS-US-366-1160), decreases from baseline were observed in the fasting values of total cholesterol and HDL-cholesterol in the Odefsey arm; no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio, direct LDL-cholesterol or triglycerides were observed in either treatment arm at Week 96.
V študiji pri bolnikih z virološko supresijo, ki so prešli z režima, ki je vseboval EFV/FTC/TDF, na zdravilo Odefsey (študija GS-US-366-1160), so v kraku z zdravilom Odefsey opazili zmanjšanje skupnega holesterola in HDL holesterola na tešče glede na začetne vrednosti; v 96. tednu niso v nobenem kraku opazili klinično pomembnih sprememb mediane vrednosti razmerja med skupnim holesterolom in HDL holesterolom, vrednosti direktnega LDL holesterola ali trigliceridov na tešče glede na začetne vrednosti.
Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity
- oslabelost, ki se začne v dlaneh in stopalih in se premika proti trupu
No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, rilpivirine or tenofovir alafenamide.
Za emtricitabin, rilpivirin ali tenofoviralafenamid ni bilo identificirane klinično pomembne farmakokinetične razlike glede na starost, spol ali etnično pripadnost.
In virologically suppressed patients
Pri bolnikih z virusno supresijo
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + 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, niso prepoznali (glejte poglavje 4.8).
had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load > 100,000 copies/mL (30/262).
Do konca 96. tedna se je pri manj bolnikih v kraku z rilpivirinom z začetno virusno obremenitvijo ≤ 100.000 kopij/ml pojavila z rezistenco povezana substitucija in/ali fenotipska rezistenca na rilpivirin (7/288) kot pri bolnikih z začetno virusno obremenitvijo > 100.000 kopij/ml (30/262).
In Study GS-US-366-1216, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 16 cells/mm3 in those who remained on FTC/RPV/TDF.
V študiji GS-US-366-1216 je bila pri bolnikih, ki so prešli na zdravilo Odefsey, povprečna sprememba števila celic CD4+ glede na začetno vrednost v 96. tednu 12 celic/mm3, pri bolnikih, ki so nadaljevali z jemanjem FTC/RPV/TDF, pa 16 celic/mm3.
Non-response Virologic failure (all patients)
Neodzivni Virološki neuspeh
Rilpivirine-containing regimen
Režimi, ki vsebujejo rilpivirin
6 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
6 Neželeni učinek, opredeljen v okviru nadzora v obdobju trženja zdravil za zdravila, ki vsebujejo tenofoviralafenamid.
A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Odefsey should be used.
Pri jemanju antagonistov receptorjev H2 je treba dosledno upoštevati načrt odmerjanja vsaj 12 ur pred uporabo zdravila Odefsey ali najmanj 4 ure po njej.
No emergent resistance to E/C/F/TAF was detected through Week 48.
Pojava rezistence proti E/C/F/TAF do vključno
In Study GS-US-366-1160, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 6 cells/mm3 in those who stayed on EFV/FTC/TDF.
V študiji GS-US-366-1160 je bila pri bolnikih, ki so prešli na zdravilo Odefsey, povprečna sprememba števila celic CD4+ glede na začetno vrednost v 96. tednu 12 celic/mm3, pri bolnikih, ki so nadaljevali z jemanjem EFV/FTC/TDF, pa 6 celic/mm3.
Odefsey [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Odefsey [samo na zunanji ovojnini]
Odefsey 200 mg/25 mg/25 mg film-coated tablets emtricitabine/rilpivirine/tenofovir alafenamide
IME ZDRAVILA Odefsey 200 mg/25 mg/25 mg filmsko obložene tablete emtricitabin/rilpivirin/tenofoviralafenamid
headache1, 3, dizziness1, 3
glavobol1,3, omotičnost1,3
Simeprevir (150 mg once daily)/ Rilpivirine
simeprevir (150 mg enkrat dnevno)/rilpivirin simeprevir:
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine.
Mehanizem delovanja in farmakodinamični učinki Emtricitabin je nukleozidni zaviralec reverzne transkriptaze (NRTI-nucleoside reverse transcriptase inhibitor) in analog 2'-deoksicitidina.
If you are taking an H2-antagonist, take it at least 12 hours before or at least 4 hours after Odefsey.
Če jemljete antagonist receptorjev H2, ga vzemite vsaj 12 ur pred zdravilom Odefsey ali najmanj 4 ure po tem.
Patients had a mean age of 48 years (range 19-76), 87% were male, 67% were White, and 27% were Black.
Bolniki so bili povprečno stari 48 let (razpon 19-76), 87 % je bilo moških, 67 % je bilo belcev in 27 % je bilo črncev.
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, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 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 proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,91 do
In a study of virologically suppressed patients switching from FTC/RPV/TDF to Odefsey (Study GS-US-366-1216), increases from baseline were observed in fasting values of total cholesterol, direct LDL-cholesterol, HDL-cholesterol, and triglycerides in the Odefsey arm; and no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio were observed in either treatment arm at Week 96.
V študiji pri bolnikih z virološko supresijo, ki so prešli z režima, ki je vseboval FTC/RPV/TDF, na zdravilo Odefsey (študija GS-US-366-1216), so v kraku z zdravilom Odefsey opazili povečanja skupnega holesterola, direktnega LDL holesterola, HDL holesterola in trigliceridov na tešče glede na začetne vrednosti; v 96. tednu niso v nobenem kraku zdravljenja opazili klinično pomembnih sprememb mediane vrednosti razmerja med skupnim holesterolom in holesterolom HDL na tešče glede na začetne vrednosti.
How to store Odefsey
Shranjevanje zdravila Odefsey
Co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Sočasna uporaba lahko povzroči pomembno zmanjšanje koncentracij rilpivirina v plazmi (zmanjšana absorpcija,
Patients had a mean age of 45 years (range 23-72), 90% were male, 75% were White, and 19% were Black.
Bolniki so bili povprečno stari 45 let (razpon 23−72), 90 % je bilo moških, 75 % je bilo belcev in 19 % je bilo črncev.
The safety of emtricitabine + 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 + tenofovir alafenamide in combination with elvitegravir + 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) pri 55 bolnikih z virološko supresijo z okužbo s HIV-1 in končno ledvično odpovedjo (eGFRCG < 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.
Emtricitabine + tenofovir alafenamide containing regimens Treatment-naïve and virologically suppressed HIV-1 infected adult patients In Study GS-US-292-0104 and Study GS-US-292-0111, patients received either E/C/F/TAF (n = 866) or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (n = 867) once daily, both given as FDC tablets.
V študiji GS-US-292-0104 in v študiji GS-US-292-0111 so bolniki prejeli bodisi E/C/F/TAF (n = 866) bodisi elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat (E/C/F/TDF) (n = 867) enkrat dnevno v obliki tablet FDC.
Antacids should only be administered either at least 2 hours before or at least 4 hours after Odefsey.
Antacide je treba dati bodisi vsaj 2 uri pred uporabo zdravila Odefsey ali vsaj 4 ure po njej.
While you are taking Odefsey
Med jemanjem zdravila Odefsey
HIV-1 RNA < 50 copies/mL Treatment difference
< 50 kopij/ml Razlika zdravljenja
Ketoconazole (400 mg once daily)/ Rilpivirine1
Antimikotiki ketokonazol (400 mg enkrat dnevno)/rilpivirin1
It is possible that in the future, long-term users of Odefsey may get kidney problems.
Obstaja možnost, da se v primeru dolgotrajne uporabe pri bolnikih kasneje pojavijo ledvične težave.
Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
famotidin (40 mg enkratni odmerek, vzet 12 ur pred rilpivirinom)/rilpivirin1
No virologic data in Week 48 or 96 window
Brez viroloških podatkov v oknu
Co-administration of ketoconazole is expected to increase plasma concentrations of tenofovir alafenamide (inhibition of P-gp).
Pričakuje se, da bo sočasna uporaba ketokonazola povzročila povečanje koncentracij tenofoviralafenamida v plazmi (zaviranje P-gp).
No new adverse reactions were identified through Week 96 in 2 clinical studies of virologically suppressed patients who switched from emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) to Odefsey (Study GS-US-366-1216) or from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to Odefsey (Study GS-US-366-1160).
V 2 kliničnih študijah pri bolnikih z virološko supresijo, ki so prešli z emtricitabina/rilpivirina/dizoproksiltenofovirijevega fumarata (FTC/RPV/TDF) na zdravilo Odefsey (študija GS-US-366-1216) ali z efavirenza/emtricitabina/dizoproksiltenofovirijevega fumarata (EFV/FTC/TDF) na zdravilo Odefsey (študija GS-US-366-1160), do konca 96. tedna niso opazili nobenih novih neželenih učinkov.
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + 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).
Each Odefsey tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Ena filmsko obložena tableta zdravila Odefsey vsebuje 200 mg emtricitabina, 25 mg rilpivirina v obliki rilpivirinijevega klorida in 25 mg tenofoviralafenamida v obliki tenofoviralafenamidijevega fumarata.
In the pooled efficacy analysis from the two Phase 3 clinical studies in adults (C209 [ECHO] and C215 [THRIVE]) through 96 weeks, patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure (17.6% with rilpivirine versus 7.6% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL (5.9% with rilpivirine versus 2.4% with efavirenz).
HIV-1 RNA kopij/ml tveganje za virološki neuspeh (17,6 % z rilpivirinom v primerjavi s 7,6 % z efavirenzom) v primerjavi z bolniki z začetno virusno obremenitvijo ≤ 100.000 HIV-1 RNA kopij/ml (5,9 % z rilpivirinom v primerjavi s 2,4 % z efavirenzom) večje.
-0.3% (95% CI: -4.2% to 3.7%)
IZ: -4,2 % do 3,7 %)
dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
deksametazon (kortikosteroid, ki se uporablja za zdravljenje vnetij in zaviranje imunskega sistema) pri peroralnem jemanju ali injiciran (razen v obliki enkratnega odmerka)
omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acid reflux disease) dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
- karbamazepin, okskarbazepin, fenobarbital in fenitoin (zdravila za zdravljenje epilepsije in preprečevanje epileptičnih napadov) - rifabutin, rifampicin in rifapentin (uporablja se za zdravljenje nekaterih bakterijskih okužb, kot je tuberkuloza) - omeprazol, dekslansoprazol, lansoprazol, rabeprazol, pantoprazol in esomeprazol (uporabljajo se za preprečevanje in zdravljenje razjed na želodcu, zgage in refluksne bolezni) - deksametazon (kortikosteroid, ki se uporablja za zdravljenje vnetij in zaviranje imunskega sistema) pri peroralnem jemanju ali injiciran (razen v obliki enkratnega odmerka)
rash1, 3
izpuščaj1,3
clarithromycin erythromycin These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
Ta zdravila lahko povečajo količino rilpivirina in tenofoviralafenamida (sestavini zdravila Odefsey) v krvi.
Odefsey: Emtricitabine and tenofovir alafenamide exposures were bioequivalent when comparing one Odefsey 200/25/25 mg film-coated tablet to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (150/150/200/10 mg) fixed-dose combination tablet following single dose administration to healthy subjects (n = 82) under fed conditions.
Zdravilo Odefsey: Biološka enakovrednost izpostavljenosti emtricitabinu in tenofoviralafenamidu je bila ugotovljena pri primerjavi ene filmsko obložene tablete zdravila Odefsey 200/25/25 mg s tableto s fiksno kombinacijo odmerkov elvitegravirja/kobicistata/emtricitabina/tenofoviralafenamida
In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of E/C/F/TAF FDC tablet were evaluated in an open-label study of 50 HIV-1 infected, treatment-naïve adolescents.
Režim, ki vsebuje emtricitabin + tenofoviralafenamid V študiji GS-US-292-0106 so ocenili učinkovitost, varnost in farmakokinetiko tablet E/C/F/TAF FDC v odprti študiji s 50 predhodno nezdravljenimi mladostniki, okuženimi s HIV1.
EFV + FTC/TDF (n = 546)
FTC/TDF (n = 437)
Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1
famotidin (40 mg enkratni odmerek, vzet 2 ur pred rilpivirinom)/rilpivirin1
Patients receiving Odefsey 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 Odefsey, se lahko še naprej razvijajo oportunistične okužbe in drugi zapleti okužbe z virusom HIV.
You must remain under the care of your doctor while taking Odefsey.
Pri jemanju zdravila Odefsey morate ostati pod zdravniškim nadzorom.
ANTIARRHYTHMICS Digoxin/ Rilpivirine
Protivirusna zdravila ledipasvir/sofosbuvir
The safety of emtricitabine + tenofovir alafenamide was evaluated through 144 weeks in an open-label 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 + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
(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 elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
Co-administration may cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Sočasna uporaba lahko pomembno zmanjša koncentracije rilpivirina (indukcija encimov CYP3A) in tenofoviralafenamida (indukcija P-gp) v plazmi.
The combination of Odefsey with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Kombinacija zdravila Odefsey s temi makrolidnimi antibiotiki lahko povzroči povečanje koncentracij rilpivirina (zaviranje encimov CYP3A)
Emtricitabine/Rilpivirine/Tenofovir alafenamide (200 mg/25 mg/25 mg once daily)
voksilaprevir (400 mg/100 mg/100 mg + 100 mg enkrat dnevno)3/ emtricitabin/rilpivirin/ tenofoviralafenamid (200 mg/25 mg/25 mg once daily)
Co-administration of ciclosporin is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Pričakuje se, da bo sočasna uporaba ciklosporina povečala koncentracije rilpivirina (zaviranje encimov CYP3A) in tenofoviralafenamida (indukcija P-gp) v plazmi.
AUC: ↓ 24% Cmin: ↓ 66% Cmax: ↔
ketokonazol: AUC: ↓ 24 % Cmin: ↓ 66 % Cmax: ↔
• feeling sick (nausea)
• omotičnost • občutek siljenja na bruhanje (navzea)
The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813).
664 celic/mm3 (razpon 126-1.813).
Small improvements in BMD were noted at 48 weeks after switching to E/C/F/TAF compared to maintaining the tenofovir disoproxil fumarate-containing regimen.
V primerjavi z režimom, ki vsebuje dizoproksiltenofovirijev fumarat, so po prehodu na E/C/F/TAF po 48 tednih zdravljenja opazili majhno izboljšanje MGK.
Cmax: ↑ 21% Sofosbuvir metabolite GS-331007:
presnovek sofosbuvirja GS-331007: AUC: ↑ 8 %
0% (95% CI: -4.8% to 4.8%)
-4,8 % do 4,8 %)
Pharmacokinetics in special populations
Farmakokinetika pri posebnih populacijah Starost, spol in etnična pripadnost
The pharmacokinetics, safety, tolerability, and efficacy of rilpivirine 25 mg once daily, in combination with an investigator-selected BR containing two NRTIs, were evaluated in Study TMC278-C213, a single-arm, open-label Phase 2 study in antiretroviral-naïve HIV-1 infected paediatric patients 12 to < 18 years of age and weighing at least 32 kg.
prenašanje in učinkovitost 25 mg rilpivirina enkrat dnevno v kombinaciji z osnovno shemo zdravljenja po izbiri raziskovalca, ki vsebuje dva NRTI, pri pediatričnih bolnikih, okuženih z virusom HIV-1, ki se predhodno niso zdravili s protiretrovirusnimi zdravili, starih od 12 do < 18 let s telesno maso najmanj 32 kg. Mediana trajanja izpostavljenosti za bolnike je bila 63,5 tednov.
Children and adolescents Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg.
Otrokom, starim 11 let ali manj, ali s telesno maso manj kot 35 kg, ne dajajte tega zdravila.
AUC: ↓ 16% Cmin: ↓ 21% Cmax: ↓ 13%
S(+) metadon: AUC: ↓ 16 % Cmin: ↓ 21 % Cmax: ↓ 13 %
One patient with emergent resistance (M184M/I) was identified in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine + tenofovir disoproxil fumarate to E/C/F/TAF in a fixed-dose combination (FDC) tablet (GS-US-292-0109, n = 959).
V klinični študiji pri bolnikih z virološko supresijo, ki so prešli z režima, ki je vseboval emtricitabin + dizoproksiltenofovirijev fumarat, na E/C/F/TAF v obliki tablete s fiksno kombinacijo odmerkov (FDC) (GS-US-292-0109, n = 959), je bil opredeljen en bolnik s pojavom rezistence (M184M/I).
In a clinical study of HIV virologically suppressed patients co-infected with chronic hepatitis B, who received E/C/F/TAF for 48 weeks (GS-US-292-1249, n = 72), 2 patients qualified for resistance analysis.
ki so 48 tednov prejemali E/C/F/TAF (GS-US-292-1249, n = 72), sta bila 2 bolnika primerna za analizo rezistence.
Inhibition of CYP3A Expected:
Zaviranje encimov CYP3A
(78.6%, 22/28) as compared to those with a baseline viral load > 100,000 copies/mL (50.0%, 4/8).
> 100.000 kopij/ml (50,0 %, 4/8).
AUC: ↑ 8%
Cmax: ↑ 8 %
Induction of CYP3A Expected:
Indukcija encimov CYP3A
tenofovir alafenamide tenofovir disoproxil lamivudine adefovir dipivoxil
tenofoviralafenamid dizoproksiltenofovirat lamivudin dipivoksiladefovirat
The proportion of patients with HIV-1 RNA < 50 copies/mL at Week 48 (TLOVR) was 72.2% (26/36).
Na začetku je bila mediana plazemska HIV-1 RNA 4,8 log10 kopij/ml, mediano število celic CD4+ je bilo 414 celic/mm3 (razpon: Delež bolnikov s HIV-1 RNA < 50 kopij/ml v 48. tednu (TLOVR) je bil 72,2 % (26/36).
Co-administration of these antifungal agents is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Pričakuje se, da bo sočasna uporaba teh antimikotikov povzročila povečanje koncentracij rilpivirina (zaviranje encimov CYP3A) in tenofoviralafenamida (zaviranje P-gp) v plazmi.
Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Priporočilo glede sočasne uporabe z zdravilom Odefsey sofosbuvir (400 mg enkrat dnevno)/rilpivirin (25 mg enkrat dnevno)
-2.0% (95% CI: -5.9% to 1.8%)
-5,9 % do 1,8 %)
Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received emtricitabine + tenofovir alafenamide in combination with elvitegravir + 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
Odefsey should not be co-administered with other medicinal products containing tenofovir alafenamide, lamivudine, tenofovir disoproxil or adefovir dipivoxil (see section 4.5).
Zdravila Odefsey se ne sme dajati skupaj z zdravili, ki vsebujejo tenofoviralafenamid, lamivudin,
The mean baseline CD4+ cell count was 709 cells/mm3 (range 104-2,527).
Povprečno število celic CD4+ na začetku je bilo 709 celic/mm3
Exposures of emtricitabine and tenofovir alafenamide given with elvitegravir + cobicistat achieved in 24 paediatric patients aged 12 to < 18 years were similar to exposures achieved in treatment-naïve adults (Table 6).
ki jih je doseglo 24 pediatričnih bolnikov, starih 12 do < 18 let, so bile podobne izpostavljenostim,
No dose adjustment of Odefsey is required in adults or in adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Odmerka zdravila Odefsey pri odraslih ali mladostnikih (starih vsaj 12 let in s telesno maso vsaj
Overall response (HIV-1 RNA < 50 copies/mL (TLOVRa))b
Celokupni odziv (HIV-1 RNA