natgillin/translations-raw huggingface dataset:
Relative to fasting conditions, the administration of Genvoya with a light meal (~400 kcal, 20% fat) or high-fat meal (~800 kcal, 50% fat) did not affect overall exposures of tenofovir alafenamide to a clinically meaningful extent (approximately 15% and 18% higher AUC with a light or high-fat meal, respectively, versus fasted).
Relativno glede na pogoje na tešče dajanje zdravila Genvoya z lahkim obrokom (~400 kcal, 20 % maščobe) ali obrokom z visoko vsebnostjo maščobe (~800 kcal, 50 % maščobe) ni vplivalo na splošno izpostavljenost tenofoviralafenamidu v klinično pomembnem obsegu (približno 15 % oz. 18 % višja vrednost AUC z lahkim obrokom oz. z obrokom z visoko vsebnostjo maščobe v primerjavi s stanjem na tešče).
Tricyclic antidepressants (TCAs) Trazodone
triciklični antidepresivi (TCA
When administering with Genvoya, the maximum daily dose of ketoconazole should not exceed 200 mg per day.
Pri dajanju z zdravilom Genvoya največji dnevni odmerek ketokonazola ne sme preseči 200 mg dnevno.
Following oral administration with food in HIV-1 infected patients, peak plasma concentrations were observed approximately 4 hours post-dose for elvitegravir, 3 hours post-dose for cobicistat, 3 hours post-dose for emtricitabine, and 1 hour post-dose for tenofovir alafenamide.
Po peroralnem dajanju s hrano bolnikom, okuženim z virusom HIV-1, so najvišje plazemske koncentracije opazili približno 4 ure po odmerku za elvitegravir, 3 ure po odmerku za kobicistat, 3 ure po odmerku za emtricitabin in 1 uro po odmerku za tenofoviralafenamid.
In a human clinical study of 35 healthy subjects, echocardiograms performed at baseline and after receiving 150 mg cobicistat once daily for at least 15 days indicated no clinically significant change in left ventricular function.
V klinični študiji pri človeku s 35 zdravimi osebami ehokardiogrami, opravljeni ob začetku in po vsaj 15-dnevnem prejemanju 150 mg kobicistata enkrat dnevno ne kažejo klinično pomembnih sprememb delovanja levega prekata.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment (see section 4.4).
Poročali so tudi o pojavu avtoimunskih bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis), vendar pa je poročani čas do pojava različen in se ti dogodki lahko pojavijo več mesecev po uvedbi zdravljenja (glejte poglavje 4.4).
Based on this, section 4.8 of the SmPC of medicinal products containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide FDC has been updated to add suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness) as new adverse drug reactions.
Na podlagi tega je bilo posodobljeno poglavje 4.8 povzetka glavnih značilnosti zdravila za zdravila, ki vsebujejo elvitegravir/kobicistat/emtricitabin/afenamidtenofovirat v obliki FDC, kjer sta bila dodana samomorilne misli in samomorilno vedenje (pri bolnikih s predhodno anamnezo depresije ali psihiatrične bolezni) kot nova neželena učinka zdravila.
Following administration of tenofovir alafenamide, plasma [14C]-radioactivity showed a time-dependent profile with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period.
Po dajanju tenofoviralafenamid je plazemska [14C]-radioaktivnost pokazala od časa odvisni profil, pre tem je bil tenofoviralafenamid najbolj zastopana vrsta radioaktivnosti v prvih nekaj urah in sečna kislina v preostalem obdobju.
Similar patterns of psychiatric disorders were observed in comparative studies of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), which lists these events in its product information (studies GS-US-292-0104 or GS-US-292-0111).
Podobne vzorce psihiatričnih motenj so opazili v primerjalnih študijah elvitegravirja/kobicistata/emtricitabina/tenofoviralafenamida (E/C/F/TAF) v primerjavi z elvitegravirjem/kobicistatom/emtricitabinom/dizoproksiltenofovirijevim fumaratom (E/C/F/TDF), ki te dogodke navaja v svojih informacijah o zdravilu (študiji GS-US-292-0104 ali GS-US-292-0111).
Based on drug-drug interaction studies conducted with Genvoya or the components of Genvoya, no clinically significant drug-drug interactions have been either observed or are expected between the components of Genvoya and the following medicinal products: entecavir, famciclovir, ribavirin, famotidine, and omeprazole.
Na podlagi študij medsebojnega delovanja z zdravilom, opravljenih z učinkovinami zdravila Genvoya, klinično pomembnih interakcij med učinkovinami zdravila Genvoya in naslednjimi zdravili bodisi niso opazili ali jih ni pričakovati: entekavir, famciklovir, ribavirin, famotidin in omeprazol.
Therefore, Genvoya should not be used during breast-feeding.
Zato se zdravilo Genvoya med dojenjem ne sme uporabljati.
Genvoya contains lactose
Zdravilo Genvoya vsebuje laktozo
If a patient misses a dose of Genvoya 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 Genvoya za več kot 18 ur, naj ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
The interactions described are based on studies conducted with Genvoya, or the components of Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), as individual agents and/or in combination, or are potential drug-drug interactions that may occur with Genvoya.
Opisane interakcije temeljijo na študijah, izvedenih z zdravilom Genvoya ali z učinkovinami zdravila Genvoya (elvitegravir, kobicistat, emtricitabin in tenofoviralafenamid), kot posamičnimi učinkovinami in/ali v kombinaciji, ali pa je možno medsebojno delovanje, ki se lahko pojavi z zdravilom Genvoya.
1 This adverse reaction was not observed in the Phase 3 clinical studies for Genvoya but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
1 Tega neželenega učinka niso opazili v kliničnih študijah faze 3 za zdravilo Genvoya, temveč je bil opredeljen v kliničnih študijah ali izkušnjah v obdobju trženja za emtricitabin pri uporabi z drugimi protiretrovirusnimi zdravili.
Concentrations of other benzodiazepines, including diazepam, may be increased when administered with Genvoya.
Koncentracije drugih benzodiazepinov, vključno z diazepamom, se lahko ob sočasnem dajanju z zdravilom Genvoya zvišajo.
• Do not breast-feed during treatment with Genvoya.
• Med zdravljenjem z zdravilom Genvoya ne dojite.
Because there is a lower tenofovir exposure in rats and mice after the administration of tenofovir alafenamide compared to tenofovir disoproxil, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil.
Zaradi manjše izpostavljenosti tenofovirju pri podganah in miših po dajanju tenofoviralafenamida v primerjavi z dizoproksiltenofoviratom so študije kancerogenosti in peri- ter postnatalne študije pri podganah izvedli samo z dizoproksiltenofoviratom.
• cholesterol lowering medicines, such as:
• zdravila za nižanje holesterola, kot sta:
What Genvoya looks like and contents of the pack
Izgled zdravila Genvoya in vsebina pakiranja
• medicines used to treat pulmonary arterial hypertension:
• zdravila za zdravljenje pljučne arterijske hipertenzije:
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 in concentrating tenofovir in peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) 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 dizoproksiltenofovirat pri koncentriranju tenofovirja v mononuklearnih celicah v periferni krvi (PBMC- peripheral blood mononuclear cells) (vključno z limfociti in drugimi ciljnimi celicami HIV) in makrofagih.
Elderly No dose adjustment of Genvoya is required in elderly patients (see sections 5.1 and 5.2).
Starejši Odmerka zdravila Genvoya pri starejših bolnikih ni treba prilagoditi (glejte poglavji 5.1 in 5.2).
In patients with severe hepatic impairment, total plasma concentrations of tenofovir alafenamide and tenofovir are lower than those seen in subjects with normal hepatic function.
Pri bolnikih s hudo jetrno okvaro so skupne plazemske koncentracije tenofoviralafenamida in tenofovirja nižje kot pri osebah z normalnim delovanjem jeter.
Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI).
Mehanizem delovanja Elvitegravir je zaviralec prenosa zapisa integraze HIV-1 (INSTI- Integrase Strand Transfer Inhibitor).
Discontinuation of Genvoya therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Genvoya pri bolnikih s hkratno okužbo s HIV in virusom HBV je lahko povezana s hudimi akutnimi poslabšanji hepatitisa.
Plasma concentrations of these medicinal products may be increased when co-administered with Genvoya, resulting in reduced serum cortisol concentrations.
Plazemske koncentracije teh zdravil se lahko ob sočasnem dajanju zdravila Genvoya povečajo, kar povzroči zmanjšanje serumskih koncentracij kortizola.
 If any of the side effects get serious tell your doctor.
 Če postane kateri koli od teh neželenih učinkov resen, obvestite svojega zdravnika.
The results reported from a prospective study (IMPAACT P1026s) showed that treatment with cobicistat and elvitegravir-containing regimens during pregnancy results in lower elvitegravir and cobicistat exposures (Table 7).
Rezultati, o katerih so poročali iz prospektivne študije (IMPAACT P1026s), so pokazali, da je zdravljenje z režimi, ki vsebujejo kobicistat in elvitegravir, med nosečnostjo povzročilo manjše izpostavljenosti elvitegravirju in kobicistatu (preglednica 7).
Following oral administration of [14C]-elvitegravir/ritonavir, 94.8% of the dose was recovered in faeces, consistent with the hepatobiliary excretion of elvitegravir; 6.7% of the administered dose was recovered in urine.
Po peroralni uporabi [14C]elvitegravirja/ritonavirja so 94,8 % odmerka izolirali iz blata, kar je v skladu s hepatobiliarnim izločanjem elvitegravirja; 6,7 % danega odmerka so izolirali iz urina.
 If you are taking any of these medicines, do not take Genvoya and tell your doctor immediately.
 Če jemljete katero od teh zdravil, ne jemljite zdravila Genvoya in takoj obvestite svojega zdravnika.
The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of elvitegravir or cobicistat has not been studied.
Učinka hude jetrne okvare (stopnje C po Child-Pughu) na farmakokinetiko elvitegravirja ali kobicistata niso proučevali.
2 This adverse reaction was not observed in the Phase 3 clinical studies for Genvoya but identified from clinical studies for elvitegravir when used with other antiretrovirals.
2 Tega neželenega učinka niso opazili v kliničnih študijah faze 3 za zdravilo Genvoya, temveč je bil opredeljen v kliničnih študijah za elvitegravir pri uporabi z drugimi protiretrovirusnimi zdravili.
There are no or limited data (less than 300 pregnancy outcomes) from the use of Genvoya in pregnant women.
Podatkov o uporabi zdravila Genvoya pri nosečnicah ni oziroma so omejeni (manj kot 300 izidov nosečnosti).
In phenotypic analyses of patients in the final resistance analysis population, 7 of 22 patients (32%) had HIV-1 isolates with reduced susceptibility to elvitegravir in the Genvoya group compared with HIV-1 isolates from 7 of 20 patients (35%) in the E/C/F/TDF group, HIV-1 isolates from 8 patients (36%) had reduced susceptibility to emtricitabine in the Genvoya group compared with HIV-1 isolates from 7 patients (35%) in the E/C/F/TDF group.
V fenotipskih analizah bolnikov končne populacije za analizo rezistence je imelo 7 od 22 bolnikov (32 %) izolate HIV-1 z zmanjšano občutljivostjo za elvitegravir v skupini z zdravilom Genvoya v primerjavi z izolati HIV-1 pri 7 od 20 bolnikov (35 %) v skupini E/C/F/TDF, izolati HIV-1 pri 8 bolnikih (36 %) pa so imeli zmanjšano občutljivost za emtricitabin v skupini z zdravilom Genvoya v primerjavi z izolati HIV-1 pri 7 bolnikih (35 %) v skupini E/C/F/TDF.
Eighty-six percent of patients (62/72) were HBV suppressed (HBV DNA < 29 IU/mL) and 42% (30/72) were HBeAg positive at baseline.
Šestinosemdeset odstotkov bolnikov (62/72) je imelo supresijo HBV (HBV DNA < 29 i.e./ml) in 42 % (30/72) je bilo HBeAg pozitivnih ob izhodišču.
EFV = efavirenz; FTC = emtricitabine; E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a Week 48 window was between Day 294 and 377 (inclusive).
EFV = efavirenz; FTC = emtricitabin; E/C/F/TDF = elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat a Okno v 48. tednu je med 294. in 377. dnevom (vključno z njima).
Genvoya is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults, adolescents and children 6 years of age and older, who weigh at least 25 kg. Genvoya reduces the amount of HIV in your body.
Zdravilo Genvoya je ena sama tableta za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti 1 (HIV-1) pri odraslih, mladostnikih in otrocih, starih 6 let in več, s telesno maso vsaj 25 kg.
suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness), depression2
Občasni samomorilne misli in poskus samomora (pri bolnikih z depresijo ali psihiatrično boleznijo v anamnezi), depresija2
Patients were randomised in a 2:1 ratio to either switch to Genvoya at baseline (n = 959), or stay on their baseline antiretroviral regimen (n = 477).
Bolniki so bili randomizirani v razmerju 2:1, bodisi za prehod na zdravilo Genvoya ob začetku (n = 959), ali za nadaljevanje začetnega protiretrovirusnega režima (n = 477).
In vitro, tenofovir alafenamide is not metabolised by CYP1A2, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
In vitro se tenofoviralafenamid ne presnavlja s CYP1A2, CYP2C8, CYP2C9, CYP2C19 ali CYP2D6.
 If you are taking an antacid or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Genvoya.
 Če jemljete antacid ali multivitaminsko dopolnilo, ga vzemite vsaj 4 ure pred zdravilom Genvoya ali najmanj 4 ure po tem.
Do not stop taking Genvoya
Ne prenehajte jemati zdravila Genvoya
Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as elvitegravir, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism.
Zaviranje presnove preko CYP3A s kobicistatom okrepi sistemsko izpostavljenost substratom CYP3A, kot je elvitegravir, kjer je biološka uporabnost omejena in razpolovna doba skrajšana zaradi presnove, odvisne od CYP3A.
Lactose (as monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate.
Laktoza (v obliki monohidrata), mikrokristalna celuloza, premreženi natrijev karmelozat, hidroksipropilceluloza, silicijev dioksid, natrijev lavrilsulfat, magnezijev stearat.
6 This study was conducted using emtricitabine/tenofovir alafenamide.
6 Ta študija je bila opravljena z emtricitabinom/tenofoviralafenamidom.
Animal studies do not indicate direct or indirect harmful effects of elvitegravir, cobicistat, or emtricitabine, administered separately, with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov ločeno uporabljenega elvitegravirja, kobicistata ali emtricitabina na parametre plodnosti, nosečnost, razvoj plodu, porod ali postnatalni razvoj.
Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs at Week 48.
Med bolniki, ki so bili ob izhodišču HBsAg pozitivni, so 3/70 (4,3 %) dosegli serokonverzijo na anti-HBs v 48. tednu.
Co-administration is contraindicated with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious or life-threatening adverse reactions.
Sočasno dajanje je kontraindicirano z zdravili, katerih očistek je močno odvisen od CYP3A in pri katerih so povišane koncentracije v plazmi povezane z resnimi ali življenjsko nevarnimi neželenimi učinki.
Start with the lowest possible dose of atorvastatin with careful monitoring upon co-administration with Genvoya.
Začnite z najnižjim možnim odmerkom atorvastatina, ob sočasnem dajanju z zdravilom Genvoya pa je potrebno skrbno spremljanje.
• medicines used to treat diabetes:
• zdravila, ki se uporabljajo za zdravljenje sladkorne bolezni:
c P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (EFV/FTC/tenofovir disoproxil, FTC/tenofovir disoproxil plus boosted atazanavir, or
c Vrednost P za test superiornosti v primerjavi odstotkov virološkega uspeha je bil po testu CMH stratificiran po predhodnem režimu zdravljenja (EFV/FTC/dizoproksiltenofovirat, FTC/dizoproksiltenofovirat z ojačanim atazanavirjem ali E/C/F/TDF).
Table 3: Pooled virologic outcomes of studies GS-US-292-0104 and GS-US-292-0111 at Weeks 48 and 144a,b
Preglednica 3: Združeni virološki izidi študij GS-US-292-0104 in GS-US-292-0111 v 48. in 144. tednua,b
Renal excretion of intact tenofovir alafenamide is a minor pathway with < 1% of the dose eliminated in urine.
Ledvično izločanje nespremenjenega tenofoviralafenamida je manj pomembna pot z < 1 % odmerka,
The median terminal plasma half-life of cobicistat following administration of E/C/F/TDF is approximately 3.5 hours and the associated cobicistat exposures provide elvitegravir Ctrough approximately 10-fold above the protein-binding adjusted IC95 for wild-type HIV-1 virus.
Mediani končni razpolovni čas kobicistata v plazmi po uporabi E/C/F/TDF je približno 3,5 ure in povezane izpostavljenosti kobicistatu povzročijo elvitegravir Ctrough, ki je približno 10-krat nad IC95, prilagojen za vezavo na protein, za divji tip virusa HIV-1.
Tenofovir alafenamide is a substrate of OATP in vitro.
Tenofoviralafenamid je in vitro substrat OATP.
Do not stop taking Genvoya without talking to your doctor.
Ne prenehajte jemati zdravila Genvoya, ne da bi se posvetovali z zdravnikom.
A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Genvoya.
Minimalna infiltracija histiocitov je bila prisotna v očesu psov pri izpostavljenosti tenofoviralafenamidu in tenofovirju, ki je bila približno 4-krat oz. 17-krat večja od pričakovane po dajanju zdravila Genvoya.
HIV-1 with the raltegravir-selected substitutions T66A/K, Q148H/K, and N155H showed cross-resistance to elvitegravir.
HIV-1 substitucijami T66A/K, Q148H/K in N155H, selekcioniranimi z raltegravirjem, je pokazal navzkrižno rezistenco na elvitegravir.
Cobicistat has no detectable antiviral activity against HIV-1 and does not antagonise the antiviral effects of elvitegravir, emtricitabine, or tenofovir.
Kobicistat nima zaznavne protivirusne aktivnosti proti HIV-1 in na protivirusne učinke elvitegravirja, emtricitabina ali tenofovirja ne deluje antagonistično.
It is important not to miss a dose of Genvoya.
Pomembno je, da ne pozabite vzeti odmerka zdravila Genvoya.
Polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), indigo carmine aluminium lake (E132), iron oxide yellow (E172).
Polivinil alkohol (E1203), titanov dioksid (E171), polietilen glikol (E1521), smukec (E553b), indigotin (E132), rumeni železov oksid (E172).
The safety of elvitegravir, cobicistat, emtricitabine or tenofovir alafenamide has not been established in these patients.
Varnosti elvitegravirja, kobicistata, emtricitabina in tenofoviralafenamida pri teh bolnikih niso dokazali.
Plasma concentrations of drospirenone are expected to be increased following co-administration with Genvoya and clinical monitoring is recommended due to the potential for hyperkalaemia (see section 4.5).
Pri sočasni uporabi drospirenona in zdravila Genvoya je pričakovano povišanje koncentracije drospirenona v plazmi in priporočeno je klinično spremljanje zaradi možnosti hiperkaliemije (glejte poglavje 4.5).
Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least 4 times greater than those expected after administration of Genvoya.
Toksičen vpliv na kosti so opazili kot zmanjšano mineralno gostoto kosti pri podganah in psih pri izpostavljenostih tenofovirju, ki so bile vsaj štirikrat večje kot izpostavljenost, pričakovana pri dajanju zdravila Genvoya.
E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
E/C/F/TDF = evitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat a Okno v 48. tednu je med 294. in 377. dnevom (vključno z njima); okno v 144. tednu je med 966. in 1049. dnevom (vključno z njima).
The use of Genvoya with oral contraceptives containing other progestogens should be avoided (see section 4.5).
Uporabi zdravila Genvoya s peroralnimi kontraceptivi, ki vsebujejo druge progestogene, se je treba izogniti (glejte poglavje 4.5).
Of the patients who were HBeAg positive at baseline, 1/30 (3.3%) achieved seroconversion to anti-HBe at Week 48.
Med bolniki, ki so bili ob izhodišču HBeAg pozitivni, je 1/30 (3,3 %) dosegel serokonverzijo na anti-HBe v 48. tednu.
Co-administration of Genvoya with medicinal products that induce CYP3A may result in decreased plasma concentrations of elvitegravir and reduced therapeutic effect of Genvoya (see “Concomitant use contraindicated” and section 4.3).
Sočasna uporaba zdravila Genvoya z zdravili, ki inducirajo CYP3A, lahko povzroči zmanjšanje plazemskih koncentracij elvitegravirja in zmanjšan terapevtski učinek zdravila Genvoya (glejte "Kontraindicirana sočasna uporaba" in poglavje 4.3).
For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Genvoya.
Za zdravljenje erektilne disfunkcije se pri sočasni uporabi z zdravilom Genvoya priporoča enkratni odmerek sildenafila največ 25 mg v 48 urah, vardenafila največ 2,5 mg v 72 urah ali tadalafila največ 10 mg v 72 urah.
Other medicines and Genvoya Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
• bronchodilators, used to treat asthma and other lung-related problems: salmeterol
• bronhodilatatorje, ki se uporabljajo za zdravljenje astme in drugih težav, povezanih s pljuči:
Cobicistat is a selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily.
Kobicistat je selektivni zaviralec encimskega mehanizma encimov citokroma P450 (CYP), poddružine CYP3A.
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil
ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE5) sildenafil tadalafil vardenafil
The most frequently reported adverse reactions in clinical studies through 144 weeks were nausea (11%), diarrhoea (7%), and headache (6%) (pooled data from Phase 3 clinical studies GS-US-292-0104 and GS-US-292-0111 in 866 treatment-naïve adult patients receiving Genvoya).
Najpogostejši neželeni učinki v kliničnih študijah do vključno 144. tedna so bili navzea (11 %), driska (7 %) in glavobol (6 %) (združeni podatki iz kliničnih študij faze 3, GS-US-292-0104 in GS-US-292-0111 pri 866 predhodno nezdravljenih odraslih bolnikih, ki so prejemali zdravilo Genvoya).