natgillin/translations-raw huggingface dataset:
The mean change from baseline in CD4+ cell count at Week 48 was -2 cells/mm3.
Povprečna sprememba števila celic CD4+ od izhodišča v 48. tednu je bila -2 celici/mm3.
Norgestimate (0.180/0.215 mg once daily)/ Ethinyloestradiol (0.025 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)4
norgestimat (0,180/0,215 mg enkrat dnevno)/etinilestradiol (0,025 mg enkrat dnevno)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)4
Dose modifications are not necessary when rosuvastatin is administered in combination with Genvoya.
Odmerka pri dajanju rosuvastatina v kombinaciji z zdravilom Genvoya ni treba prilagoditi.
Based on data from an in vitro study, co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g., febuxostat) is not expected to increase systemic exposure to tenofovir in vivo.
Na podlagi podatkov iz študije in vitro ni pričakovati, da bi sočasno dajanje tenofoviralafenamida in zaviralcev ksantin oksidaze (npr.
ORAL ANTI-DIABETICS Metformin
PERORALNI ANTIDIABETIKI metformin
Concurrent administration of salmeterol and Genvoya is not recommended.
Sočasno dajanje salmeterola in zdravila Genvoya se ne priporoča.
No dose adjustment of buprenorphine/naloxone is required.
Prilagoditev odmerka buprenorfina/naloksona ni potrebna.
Overall, 22% had baseline plasma HIV-1 RNA > 100,000 copies/mL.
Celokupno je imelo 22 % začetno plazemsko HIV-1 RNA
Cobicistat was not mutagenic or clastogenic in conventional genotoxicity assays.
V običajnih testih genotoksičnosti kobicistat ni bil mutagen ali klastogen.
dihydroergotamine, ergometrine, ergotamine (used to treat migraine headache)
rifampicin (uporablja se za preprečevanje in zdravljenje tuberkuloze in drugih okužb) dihidroergotamin, ergometrin, ergotamin (uporabljajo se za zdravljenje glavobola zaradi migrene)
You must remain under the care of your doctor while taking Genvoya.
Pri jemanju zdravila Genvoya morate ostati pod zdravniškim nadzorom.
HIV-1 RNA < 50 copies/mL Treatment difference
HIV-1 RNA < 50 kopij/ml Razlika zdravljenja
Adults and paediatric patients aged 6 years and older, weighing at least 25 kg One tablet to be taken once daily with food.
Odrasli in pediatrični bolniki, stari 6 let in več, s telesno maso vsaj 25 kg
NARCOTIC ANALGESICS Methadone (80-120 mg)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
metadon (80-120 mg)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)
f n = 539 (TAF) or 841 (TFV) adults.
a n = 24 mladostnikov b n = 23 mladostnikov c AUClast d n = 15 mladostnikov e n = 19 odraslih f n = 539 (TAF) ali 841 (TFV) odraslih
Genvoya [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Genvoya [samo na zunanji ovojnini]
Concentrations of telithromycin and/or cobicistat may be altered with co-administration of Genvoya.
Koncentracije telitromicina in/ali kobicistata se lahko pri sočasnem dajanju zdravila Genvoya spremenijo.
Dose modifications are not necessary when administered in combination with Genvoya.
Odmerka pri dajanju v kombinaciji z zdravilom Genvoya ni treba prilagoditi.
In treatment-naïve patients
Pri predhodno nezdravljenih bolnikih
Up to Week 144, the development of one or more primary elvitegravir, emtricitabine, or tenofovir alafenamide resistance-associated mutations was observed in HIV-1 isolates from 12 of 22 patients with evaluable genotypic data from paired baseline and Genvoya treatment-failure isolates (12 of 866 patients [1.4%]) compared with 12 of 20 treatment-failure isolates from patients with evaluable genotypic data in the E/C/F/TDF treatment group (12 of 867 patients [1.4%]).
Genvoya (12 od 866 bolnikov [1,4 %]) v primerjavi z 12 od 20 izolatov neuspešnega zdravljenja pri bolnikih, pri katerih je bilo mogoče oceniti genotipske podatke, v skupini, zdravljeni z E/C/F/TDF (12 od 867 bolnikov [1,4 %]).
The safety of Genvoya was evaluated through 48 weeks in HIV-1 infected adolescent patients between the ages of 12 to < 18 years weighing ≥ 35 kg, who were either treatment-naïve (GS-US-292-0106, n = 50), or who were virologically suppressed (GS-US-292-1515, n = 50), and in virologically suppressed children between the ages of 8 to < 12 years weighing > 25 kg (GS-US-292-0106, n = 23).
Varnost zdravila Genvoya so ocenili v 48 tednih pri mladostnikih, okuženih s HIV-1, starih od 12 do < 18 let, s telesno maso ≥ 35 kg, ki so bili bodisi predhodno nezdravljeni (GS-US-292-0106, n = 50)
In Study GS-US-292-1515, the efficacy and safety of Genvoya were evaluated in an open-label study in HIV-1 infected, virologically suppressed adolescents between the ages of 12 and 18 years, weighing ≥ 35 kg (n = 50).
V študiji GS-US-292-1515 so ocenili učinkovitost in varnost zdravila Genvoya v odprti študiji z mladostniki, okuženimi s HIV-1, z virološko supresijo, starimi med 12 in 18 let, s telesno maso
(may affect up to 1 in 10 people)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 do 10 bolnikov)
• corticosteroids including:
Znaki osteonekroze so:
The mean change from baseline in CD4+ cell count and percentage at Week 48 was -90 cells/mm3 and -1.3%, respectively.
Povprečna sprememba števila celic CD4+ od začetka je bila -90 celic/mm3, povprečna sprememba v odstotkih pa -1,3 %.
PC: {number} SN: {number} NN: {number} [Outer packaging only]
PC: {številka}
Caution should be exercised when co-administering Genvoya with pitavastatin.
Pri sočasnem dajanju zdravila Genvoya s pitavastatinom je potrebna previdnost.
On the basis of the scientific conclusions for cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide is unchanged subject to the proposed changes to the product information
CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) kobicistat/elvitegravir/emtricitabin/tenofoviralafenamid nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Co-administration of Genvoya and orally administered midazolam is contraindicated (see section 4.3).
Sočasno dajanje zdravila Genvoya in peroralno dajanje midazolama je kontraindicirano (glejte poglavje 4.3).
Concentrations of rosuvastatin are transiently increased when administered with elvitegravir and cobicistat.
Koncentracije rosuvastatina se pri dajanju z elvitegravirjem in kobicistatom prehodno zvišajo.
Corresponding steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) were 1.1 ± 0.40 µg/mL, 8.3 ± 3.8 µg•h/mL, and 0.05 ± 0.13 µg/mL for cobicistat; 1.9 ± 0.5 µg/mL, 13 ± 4.5 µg•h/mL, and 0.14 ± 0.25 µg/mL for emtricitabine.
0,05 ± 0,13 µg/ml za kobicistat, 1,9 ± 0,5 µg/ml, 13 ± 4,5 µg•h/ml in 0,14 ± 0,25 µg/ml za emtricitabin.
While you are taking Genvoya
Med jemanjem zdravila Genvoya
dabigatran (used to prevent and treat blood clots) rifampicin (used to prevent and treat tuberculosis and other infections)
dabigatran (uporablja se za preprečevanje in zdravljenje krvnih strdkov) rifampicin (uporablja se za preprečevanje in zdravljenje tuberkuloze in drugih okužb) dihidroergotamin, ergometrin, ergotamin (uporabljajo se za zdravljenje glavobola zaradi migrene)
Black, and 14% were Asian.
Azijcev in 88 % črncev.
No virologic data at Week 48 or 144 window Discontinued study drug due to AE or deathd
HIV-1 RNA ≥ 50 kopij/mlc Brez viroloških podatkov v oknu 48. ali 144. tedna
4.1% (95% CI: 1.6% to 6.7%, p < 0.001c)
4,1 % (95 % IZ: 1,6 % do 6,7 %,
Patients in Cohort 1 had a mean age of 15 years (range 12 to 17), were 44% male, 12% Asian, and 88% Black.
Povprečna starost bolnikov v kohorti 1 je bila 15 let (razpon 12 do 17 let), 44 % je bilo moških, 12 %
ANTICONVULSANTS Carbamazepine (200 mg twice daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
ANTIKONVULZIVI karbamazepin (200 mg dvakrat dnevno)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)
No dose adjustment of ledipasvir/sofosbuvir and Genvoya is warranted upon co-administration.
Prilagoditev odmerka ledipasvirja/sofosbuvirja in zdravila Genvoya pri sočasni uporabi ni potrebna.
The use of Genvoya should be accompanied by the use of effective contraception (see sections 4.4 and 4.5).
Ženske v rodni dobi/uporaba kontracepcije pri moških in ženskah Pri uporabi zdravila Genvoya je treba uporabljati učinkovito kontracepcijo (glejte poglavji 4.4 in 4.5).
Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Ena tableta vsebuje 150 mg elvitegravirja, 150 mg kobicistata, 200 mg emtricitabina in tenofoviralafenamidijev fumarat v količini, ki ustreza 10 mg tenofoviralafenamida.
A study of the pharmacokinetics of cobicistat-boosted elvitegravir was performed in non-HIV-1 infected patients with moderate hepatic impairment (Child-Pugh Class B).
Pri bolnikih z zmerno jetrno okvaro (stopnje B po Child-Pughu) brez okužbe z virusom HIV-1 so izvedli farmakokinetično študijo elvitegravirja, okrepljenega s kobicistatom.
Atorvastatin: AUC: ↑ 160% Cmin: NC Cmax: ↑ 132%
AUC: ↑160 % Cmin: NI Cmax: ↑132 %
Ketoconazole (200 mg twice daily)/ Elvitegravir (150 mg once daily)2
Antimikotiki ketokonazol (200 mg dvakrat dnevno)/elvitegravir (150 mg enkrat dnevno)2
The mean baseline CD4+ cell count was 427 cells/mm3 (range 0-1,360) and 13% had a CD4+ cell count < 200 cells/mm3.
0-1.360) in 13 % jih je imelo število celic CD4+ < 200 celic/mm3.
Concentrations of beta-blockers may be increased when co-administered with cobicistat.
Koncentracije antagonistov beta se lahko pri sočasni uporabi s kobicistatom zvišajo.
Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Ena filmsko obložena tableta vsebuje 150 mg elvitegravirja, 150 mg kobicistata, 200 mg emtricitabina in tenofoviralafenamidijev fumarat v količini, ki ustreza 10 mg tenofoviralafenamida.
Each Genvoya film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Ena filmsko obložena tableta zdravila Genvoya vsebuje 150 mg elvitegravirja, 150 mg kobicistata, 200 mg emtricitabina in tenofoviralafenamidijev fumarat v količini, ki ustreza 10 mg tenofoviralafenamida.
• contraceptive pill, used to prevent pregnancy
• kontracepcijske tabletke, ki se uporabljajo za preprečevanje nosečnosti • zdravila za zdravljenje erektilne disfunkcije, ki se uporabljajo za zdravljenje impotence,
Concentrations of sertraline are not affected upon co-administration with Genvoya.
Sočasno dajanje z zdravilom Genvoya ne vpliva na koncentracije sertralina.
Improvements in BMD were noted at 96 weeks after switching to Genvoya from a tenofovir disoproxil-containing regimen compared to maintaining the tenofovir disoproxil-containing regimen.
V primerjavi z režimom, ki vsebuje dizoproksiltenofovirat, so po prehodu z režima, ki vključuje dizoproksiltenofovirat, na zdravilo Genvoya po 96 tednih zdravljenja opazili izboljšanje MGK.
Anti-hepatitis C virus medicinal products Ledipasvir (90 mg once daily)/ Sofosbuvir (400 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Zdravila proti virusu hepatitisa C ledipasvir (90 mg enkrat dnevno)/sofosbuvir (400 mg enkrat dnevno)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)/emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (10 mg enkrat dnevno)5
Clinical monitoring should be made upon co-administration with Genvoya.
Pri sočasnem dajanju z zdravilom Genvoya je treba uvesti klinično spremljanje.
AUC: ↑ 126% Cmin: ↑ 167% Cmax: ↑ 108%
Cmin: ↑ 167 % Cmax: ↑ 108 %
Sofosbuvir metabolite GS-331007:
presnovek sofosbuvirja GS-331007: AUC: ↑ 48 %
Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Genvoya.
Genvoya, se priporoča skrbno spremljanje in prilagoditev odmerka metformina.
Exposures of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide achieved in 24 adolescent patients aged 12 to < 18 years who received Genvoya in Study GS-US-292-0106 were similar to exposures achieved in treatment-naïve adults following administration of Genvoya (Table 5).
Izpostavljenosti elvitegravirju, kobicistatu, emtricitabinu, tenofovirju in tenofoviralafenamidu, ki jih je doseglo 24 mladostnikov, starih 12 do < 18 let, ki so prejemali zdravilo Genvoya v študiji
ANTI-INFECTIVES Antifungals
ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ
No clinically relevant pharmacokinetic differences due to gender or ethnicity have been identified for cobicistat-boosted elvitegravir, cobicistat, emtricitabine, or tenofovir alafenamide.
Za elvitegravir, ojačan s kobicistatom, kobicistat, emtricitabin ali tenofoviralafenamid ni bilo identificirane klinično pomembne farmakokinetične razlike glede na spol ali etnično pripadnost.
Therapeutic monitoring is recommended upon co-administration with Genvoya.
Pri sočasni uporabi z zdravilom Genvoya se priporoča terapevtsko spremljanje.
• tenofovir disoproxil
• dipivoksiladefovirat
alfuzosin (used to treat an enlarged prostate gland) dabigatran (used to prevent and treat blood clots) amiodarone, quinidine (used to correct irregular heartbeats)
• Če jemljete katero od naslednjih zdravil: alfuzosin (uporablja se za zdravljenje povečanja prostate) dabigatran (uporablja se za preprečevanje in zdravljenje krvnih strdkov) amiodaron, kinidin (uporabljata se za zdravljenje nepravilnega srčnega utripa) karbamazepin, fenobarbital, fenitoin (uporabljajo se za preprečevanje epileptičnih napadov)
HIV-1 RNA ≥ 50 copies/mLd
HIV-1 RNA < 50 kopij/mle
(may affect more than 1 in 10 people) • feeling sick (nausea)
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
The mean change from baseline in CD4+ cell count and percentage at Week 48 was -43 cells/mm3 and -0.1%, respectively.
Povprečna sprememba števila celic CD4+ od začetka je bila -43 celic/mm3, povprečna sprememba v odstotkih pa -0,1 %.
No clinically relevant differences in elvitegravir, cobicistat, or tenofovir alafenamide pharmacokinetics were observed in patients with end stage renal disease on chronic haemodialysis as compared to those with normal renal function.
Pri bolnikih s končno ledvično odpovedjo na kronični hemodializi niso opazili klinično pomembnih razlik v farmakokinetiki elvitegravirja, kobicistata ali tenofoviralafenamida v primerjavi s tistimi z normalnim delovanjem ledvic.
Co-administration of Genvoya and lovastatin and simvastatin is contraindicated (see section 4.3).
Sočasno dajanje zdravila Genvoya z lovastatinom oz. simvastatinom je kontraindicirano (glejte poglavje 4.3).
AUC: ↑ 37%
kobicistat: AUC: ↑ 53 %
No dose adjustment of sofosbuvir/velpatasvir and Genvoya is warranted upon co-administration.
Prilagoditev odmerka sofosbuvirja/velpatasvirja in zdravila Genvoya pri sočasni uporabi ni potrebna.
Skin and subcutaneous tissue disorders Common:
Bolezni kože in podkožja
Caution is warranted and clinical monitoring is recommended upon co-administration with Genvoya.
Pri sočasni uporabi z zdravilom Genvoya je potrebna previdnost, priporoča pa se tudi klinično spremljanje.
• Signs of inflammation or infection • Joint pain, stiffness or bone problems
• znake vnetja ali okužbe
Tenofovir alafenamide:
tenofoviralafenamid:
HIV-1 RNA ≥ 50 copies/mLc
HIV-1 RNA < 50 kopij/mlf
ANTIDEPRESSANTS Sertraline (50 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
ANTIDEPRESIVI sertralin (50 mg enkratni odmerek)/ elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)/emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (10 mg enkrat dnevno)5
Clinical monitoring of therapeutic effects and adverse reactions is recommended when these medicinal products are concomitantly administered with Genvoya.
Pri uporabi teh zdravil z zdravilom Genvoya se priporoča klinično spremljanje terapevtskih in neželenih učinkov.
HIV-1 infected virologically suppressed patients
Navzkrižna rezistenca pri predhodno nezdravljenih bolnikih ali bolnikih z virusno supresijo, okuženih s HIV-1
Orally administered midazolam (2.5 mg single dose)/ Tenofovir alafenamide (25 mg once daily)
(2,5 mg enkratni odmerek)/tenofoviralafenamid (25 mg enkrat dnevno)
• erectile dysfunction medicines, used to treat impotence, such as:
• antikoagulante, ki se uporabljajo za preprečevanje in zdravljenje krvnih strdkov, kot so:
An improved renal safety profile was maintained through Week 96 in patients who switched to Genvoya compared with those who stayed on a tenofovir disoproxil-containing regimen.
V primerjavi z bolniki, ki so ostali na režimu, ki vključuje dizoproksiltenofovirat, se je pri bolnikih, ki so prešli na zdravilo Genvoya, profil varnosti za ledvice ohranil skozi 96. teden.
Caution should be exercised, including consideration of dose reduction, when co-administering Genvoya with tadalafil for the treatment of pulmonary arterial hypertension.
Pri sočasnem dajanju zdravila Genvoya s tadalafilom za zdravljenje pljučne arterijske hipertenzije je potrebna previdnost,
Three patients with emergent HIV-1 resistance to Genvoya were identified (M184M/I; M184I+E92G; M184V+E92Q) up to Week 96 in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine/tenofovir disoproxil and a third agent (GS-US-292-0109, n = 959).
96. tedna trije bolniki opredeljeni s pojavom rezistence virusa HIV-1 na zdravilo Genvoya (M184M/I; M184I+E92G; M184V+E92Q).
Lactose (as monohydrate) Microcrystalline cellulose Croscarmellose sodium Hydroxypropyl cellulose Silicon dioxide Sodium lauryl sulfate Magnesium stearate
buspiron klorazepat diazepam estazolam flurazepam lorazepam triazolam zolpidem
Atorvastatin (10 mg single dose)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)/Emtricitabine (200 mg once daily)/Tenofovir alafenamide (10 mg once daily)
atorvastatin (10 mg enkratni odmerek)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)/emtricitabin (200 mg enkrat dnevno)/tenofovir alafenamid (10 mg enkrat dnevno)
3.7% (95% CI: 0.4% to 7.0%, p < 0.017c)
3,7 % (95 % IZ: 0,4 % do 7,0 %.
Clinical monitoring is recommended upon co-administration of Genvoya.
Po sočasnem dajanju zdravila Genvoya se priporoča klinično spremljanje.
Clinical monitoring is recommended and a dose decrease may be necessary when these agents are co-administered with Genvoya.
Pri sočasni uporabi teh učinkovin z zdravilom Genvoya se priporoča klinično spremljanje in morebiti bo potrebno zmanjšanje odmerka.
The safety of Genvoya in 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825).
Varnost zdravila Genvoya 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.
Co-administration with Genvoya may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk.
Sočasno dajanje z zdravilom Genvoya lahko povzroči zvišanje koncentracij DOAC v plazmi,
Triazolam
triamcinolonom
In studies in treatment-naïve patients, Genvoya was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF as measured by DXA analysis of hip (mean change: -0.8% versus -3.4%, p < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001) after 144 weeks of treatment.
kolka (povprečna sprememba: -0,8 % v primerjavi z -3,4 %, p < 0,001) in ledvene hrbtenice (povprečna sprememba: -0,9 % v primerjavi z -3,0 %, p < 0,001), kot E/C/F/TDF.
HMG CO-A REDUCTASE INHIBITORS Rosuvastatin (10 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
rosuvastatin (10 mg enkratni odmerek)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)
No dose adjustment of Genvoya 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 (CrCl- creatinine clearance) ≥ 30 ml/min ni treba prilagoditi.
Buprenorphine/Naloxone (16/4 to 24/6 mg)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
24/6 mg)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)
• vomiting
• omotičnost
Five subjects had virologic failure through the end of the study; no phenotypic or genotypic resistance to Genvoya was detected.
Pet oseb je imelo do konca študije virološki neuspeh;
Patients should be informed that dizziness has been reported during treatment with Genvoya.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Bolnike je potrebno opozoriti, da se lahko v času zdravljenja z zdravilom Genvoya pojavi omotičnost.
Elvitegravir: AUC: ↑ 48% Cmin: ↑ 67%
sofosbuvir: AUC: ↑ 47 %
N/A
SN: {številka}
• stomach pain
• bruhanje • bolečine v trebuhu
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Polyethylene glycol (E1521) Talc (E553b)
mikrokristalna celuloza premreženi natrijev karmelozat hidroksipropilceluloza silicijev dioksid natrijev lavrilsulfat magnezijev stearat Filmska obloga polivinilalkohol (E1203) titanov dioksid (E171)
NAME OF THE MEDICINAL PRODUCT
Prekinitev zdravljenja z zdravilom
Concentrations of warfarin may be affected upon co-administration with Genvoya.
Sočasno dajanje z zdravilom Genvoya lahko vpliva na koncentracije varfarina.
• tenofovir alafenamide
• tenofoviralafenamid
Sofosbuvir (400 mg once daily)/ Velpatasvir (100 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
voksilaprevir (400 mg/100 mg/100 mg+100 mg enkrat dnevno)7/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)/emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (10 mg enkrat dnevno)5
Mechanism of action
Začetni režim
Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
velpatasvir (100 mg enkrat dnevno)/ elvitegravir (150 mg enkrat dnevno)/ kobicistat (150 mg enkrat dnevno)/ emtricitabin (200 mg enkrat dnevno)/ tenofoviralafenamid (10 mg enkrat dnevno)5
Sirolimus
Plodnost
Plasma concentrations of drospirenone may be increased when co-administered with cobicistat-containing products.
Pri sočasnem dajanju z zdravili, ki vsebujejo kobicistat, se lahko koncentracije drospirenona v plazmi povišajo.
Flurazepam
flukonazol
No dose adjustment of sofosbuvir/velpatasvir/voxilaprevir and Genvoya is warranted upon co-administration.
Prilagoditev odmerka sofosbuvirja/velpatasvirja/voksilapr evirja in zdravila Genvoya pri sočasni uporabi ni potrebna.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA PLASTENKI IN ŠKATLI
Antimycobacterials Rifabutin (150 mg every other day)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Priporočilo glede sočasne uporabe z zdravilom Genvoya rifabutin (150 mg na vsaka dva dni)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)
alfuzosin (used to treat an enlarged prostate gland) amiodarone, quinidine (used to correct irregular heartbeats)
Zdravila, ki jih ne smete nikoli uporabljati skupaj z zdravilom Genvoya: alfuzosin (uporablja se za zdravljenje povečanja prostate) amiodaron, kinidin (uporabljata se za zdravljenje nepravilnega srčnega utripa) karbamazepin, fenobarbital, fenitoin (uporabljajo se za preprečevanje epileptičnih napadov)
Rosuvastatin: AUC: ↑ 38% Cmin: N/A Cmax: ↑ 89%
rosuvastatin: AUC: ↑ 38 %
Co-administration with Genvoya may result in increased plasma concentrations of sildenafil and tadalafil, which may result in PDE-5 inhibitor-associated adverse reactions.
Sočasno dajanje z zdravilom Genvoya lahko povzroči zvišanje koncentracij sildenafila in tadalafila v plazmi,