natgillin/translations-raw huggingface dataset:
• sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem and lorazepam
• sedative i hipnotike, primjenjuju se za liječenje tjeskobe: buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem i lorazepam
Table 4: Virologic outcomes of Study GS-US-292-0109 at Weeks 48a and 96b
Tablica 4. Virološki ishodi ispitivanja GS-US-292-0109 u 48.a i 96.b tjednu
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.
Od 10 bolesnika koji nisu imali supresiju HBV-a pri ishodištu (HBV DNA ≥ 29 IU/ml), u 7 je došlo do supresije, 2 su zadržala detektibilnost, a za 1 bolesnika podaci nisu poznati.
2 These studies were performed with ritonavir boosted elvitegravir.
Ta su ispitivanja provedena s ritonavirom pojačanim elvitegravirom.
Overall, 22% had baseline plasma HIV-1 RNA > 100,000 copies/mL.
Sveukupno, 22% bolesnika imalo je početnu razinu HIV-1 RNK u plazmi > 100 000 kopija/ml.
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 temelju toga je dio 4.8 sažetka opisa svojstava lijekova koji sadrže elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid u fiksnoj kombinaciji ažuriran kako bi se dodale suicidalne ideacije i pokušaj suicida (u bolesnika s otprije postojećom depresijom ili psihijatrijskom bolešću u anamnezi) kao nove nuspojave na lijek.
Co-administration of Genvoya and sildenafil for the treatment of pulmonary arterial hypertension is contraindicated.
Istodobna primjena lijeka Genvoya i sildenafila za liječenje plućne arterijske hipertenzije je kontraindicirana.
30 film-coated tablets 30 tablets
OBLIK I SADRŽAJ 30 filmom obloženih tableta 30 tableta
Following administration of [14C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (~86%) and faeces (~14%).
Nakon primjene [14C]emtricitabina, potpuna izolacija doze emtricitabina ostvarena je u urinu (~86%) i stolici (~14%).
Discontinuation of Genvoya therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Prekid terapije lijekom Genvoya u bolesnika istodobno zaraženih HIV-om i HBV-om može biti povezan s teškim akutnim egzacerbacijama hepatitisa.
The safety of elvitegravir, cobicistat, emtricitabine or tenofovir alafenamide has not been established in these patients.
Sigurnost elvitegravira, kobicistata, emtricitabina ili tenofoviralafenamida u tih bolesnika nije ustanovljena.
b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/µL, 50-199 cells/µL, or ≥ 200 cells/µL), and by region (US or ex-US).
b U oba ispitivanja bolesnici su stratificirani prema početnoj HIV-1 RNK (≤ 100 000 kopija/ml, > 100 000 kopija/ml do ≤ 400 000 kopija/ml, ili > 400 000 kopija/ml), prema broju CD4+ stanica (< 50 stanica/µl, 50-199 stanica/µl ili ≥ 200 stanica/µl) te po regiji (SAD ili izvan SAD-a).
At Week 48, the virologic response rate to Genvoya in treatment-naïve HIV-1 infected adolescents was similar to response rates in studies of treatment-naïve HIV-1 infected adults.
U 48. tjednu stopa virološkog odgovora na lijek Genvoya u adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni bila je slična stopama odgovora u ispitivanjima odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni.
Based on these limited data, the safety profile of Genvoya in patients with HIV/HBV co-infection was similar to that in patients with HIV-1 monoinfection.
Na temelju ovih ograničenih podataka, sigurnosni profil lijeka Genvoya u bolesnika koji su istodobno bili zaraženi HIV-om i HBV-om bio je sličan onome u bolesnika zaraženih samo virusom HIV-1.
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
Na temelju znanstvenih zaključaka za kobicistat/elvitegravir/emtricitabin/tenofoviralafenamid, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) kobicistat/elvitegravir/emtricitabin/tenofoviralafenamid nepromijenjen, uz predložene izmjene informacija o lijeku.
Genvoya has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, Genvoya is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Genvoya nije ispitana u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) te se stoga primjena lijeka Genvoya ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
Mean % change of cobicistat pharmacokinetic parametersa
Srednja vrijednost % promjene farmakokinetičkih parametara kobicistataa
Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to desacetyl-rifabutin.
Potreban je stroži nadzor nuspojava povezanih s rifabutinom, uključujući i neutropeniju i uveitis zbog očekivanog povećanja izloženosti dezacetilrifabutinu.
Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Tenofoviralafenamid se uglavnom eliminira nakon metabolizma u tenofovir.
Elvitegravir is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A may affect the exposure of elvitegravir.
Elvitegravir se prvenstveno metabolizira putem CYP3A te lijek koji inducira ili inhibira CYP3A može utjecati na izloženost elvitegraviru.
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).
Bolesnici su na početku bili randomizirani u omjeru 2:1 kako bi se prebacili na lijek Genvoya (n = 959) ili ostali na svom početnom antiretrovirusnom režimu (n = 477).
In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl < 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL).
U zasebnom ispitivanju faze I samo emtricitabina, srednja vrijednost sistemske izloženosti emtricitabinu bila je viša u bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl < 30 ml/min) (33,7 µg•h/ml) nego u ispitanika s normalnom funkcijom bubrega (11,8 µg•h/ml).
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 liječenje erektilne disfunkcije preporučuje se primjena jedne doza sildenafila od najviše 25 mg u 48 sati, vardenafila od najviše 2,5 mg u 72 sata ili tadalafila od najviše 10 mg u 72 sata istodobno s lijekom Genvoya.
Elvitegravir undergoes primarily oxidative metabolism via CYP3A, and is secondarily glucuronidated via UGT1A1/3 enzymes.
Elvitegravir primarno prolazi kroz oksidativni metabolizam putem CYP3A i sekundarno prolazi glukuronidaciju putem enzima UGT1A1/3.
Genvoya contains lactose monohydrate.
Genvoya sadrži laktozu hidrat.
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).
U odnosu na stanje natašte, primjena lijeka Genvoya s laganim obrokom (∼400 kcal, 20%masnoće) ili visokomasnim obrokom (∼800 kcal, 50% masnoće) nije utjecala na ukupne izloženosti tenofoviralafenamidu u klinički značajnoj mjeri (otprilike 15% i 18% veći AUC uz lagani ili visokomasni obrok u odnosu na stanje natašte).
Therefore, Genvoya should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5):
Stoga se Genvoya ne smije primjenjivati istodobno s lijekovima koji uključuju, ali nisu ograničeni na sljedeće lijekove (vidjeti dijelove 4.4 i 4.5):
Each tablet contains 61 mg lactose (as monohydrate).
Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 61 mg laktoze (u obliku hidrata).
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.
Toksičnost za kost uočena je kao smanjena mineralna gustoća kostiju u štakora i pasa pri izloženostima tenofoviru najmanje četiri puta većima od onih očekivanih nakon primjene lijeka Genvoya.
• If you notice within 18 hours of the time you usually take Genvoya, you must take the tablet as soon as possible.
• Ako to primijetite unutar manje od 18 sati od vremena kad obično uzimate lijek Genvoya, tabletu morate uzeti što prije.
Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Bolesnici s bolešću jetre, uključujući kronični hepatitis B ili C, koji se liječe antiretrovirusnim lijekovima, izloženi su većemu riziku od teških i potencijalno fatalnih jetrenih komplikacija.
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/tenofovirdizoproksilfumarat a Okvir 48. tjedna bio je između 294. i 377. dana (uključujući).
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.
Poboljšani profil sigurnosti primjene za bubrege održan je do 96. tjedna u bolesnika koji su prešli na lijek Genvoya u usporedbi s onima koji su ostali na režimu s tenofovirdizoproksilom.
Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with Genvoya.
Kobicistat reverzibilno inhibira MATE1, stoga se koncentracije metformina mogu povećati s istodobnom primjenom lijeka Genvoya.
Genvoya should not be co-administered with other antiretroviral medicinal products.
Genvoya se ne smije primjenjivati istodobno s drugim antiretrovirusnim lijekovima.
 If you are taking any of these medicines, do not take Genvoya and tell your doctor immediately.
 Ako uzimate bilo koji od ovih lijekova, nemojte uzimati lijek Genvoya i odmah o tome obavijestite svog liječnika.
• antacids, used to treat heartburn or acid reflux (see also section 3, How to take Genvoya).
• antacide, primjenjuju se za liječenje žgaravice ili refluksa kiseline (također pogledajte dio 3,
It is not known whether cobicistat, emtricitabine, or tenofovir alafenamide are inhibitors of other UGT enzymes.
Nije poznato jesu li kobicistat, emtricitabin ili tenofoviralafenamid inhibitori drugih UGT enzima.
When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Nakon korekcije za vezanje na proteine, koncentracije nevezanog (slobodnog) tenofoviralafenamida u plazmi kod teškog oštećenja funkcije jetre slične su onima kod normalne funkcije jetre.
At screening, 42% of patients were receiving FTC/tenofovir disoproxil plus atazanavir (boosted by either cobicistat or ritonavir), 32% of patients were receiving E/C/F/TDF, and 26% of patients were receiving EFV/FTC/tenofovir disoproxil.
Pri probiru je 42% bolesnika primalo FTC/tenofovirdizoproksil plus atazanavir (pojačan ili kobicistatom ili ritonavirom), 32% bolesnika primalo je E/C/F/TDF te je 26% bolesnika primalo EFV/FTC/tenofovirdizoproksil.
The mean plasma to blood drug concentration ratio was 1.37.
Omjer srednje vrijednosti koncentracije lijeka u plazmi i koncentracije lijeka u krvi iznosio je 1,37.
Dose modifications are not necessary when rosuvastatin is administered in combination with Genvoya.
Izmjene doze nisu potrebne kada se rosuvastatin primjenjuje u kombinaciji s lijekom Genvoya.
Of the patients who were HBeAg positive at baseline, 1/30 (3.3%) achieved seroconversion to anti-HBe at Week 48.
Od bolesnika koji su na početku bili HBeAg pozitivni, 1/30 (3,3%) postiglo je serokonverziju na anti-HBe u 48. tjednu.
Following oral administration of boosted [14C]-elvitegravir, elvitegravir was the predominant species in plasma, representing ~94% of the circulating radioactivity.
Nakon peroralne primjene pojačanog [14C]elvitegravira, elvitegravir je bio najzastupljeniji u plazmi, predstavljajući ~ 94% cirkulirajuće radioaktivnosti.
In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja CART može doći do upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, koja može uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
Sofosbuvir metabolite GS-566500:
Metabolit sofosbuvira GS-566500: AUC: ↔
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 P-vrijednost za test superiornosti kojim su uspoređeni postotci virološkog uspjeha iz CMH testa stratificirano prema prvotnom režimu liječenja (EFV/FTC/tenofovirdizoproksil, FTC/tenofovirdizoproksil plus pojačani atazanavir ili E/C/F/TDF).
The safety and efficacy of Genvoya in patients with significant underlying liver disorders have not been established.
Sigurnost i djelotvornost primjene lijeka Genvoya u bolesnika s postojećim značajnim bolestima jetre nisu ustanovljene.
If Genvoya is stopped for any reason, speak to your doctor before you restart taking Genvoya tablets.
Ako zbog bilo kojeg razloga prestanete uzimati lijek Genvoya, porazgovarajte s liječnikom prije nego što ponovno počnete uzimati tablete lijeka Genvoya.
There is insufficient information on the effects of elvitegravir, cobicistat, emtricitabine and tenofovir in newborns/infants.
Nema dovoljno podataka o učincima elvitegravira, kobicistata, emtricitabina i tenofovira na novorođenčad/dojenčad.
Each bottle contains silica gel desiccant and polyester coil.
Jedna boca sadrži sredstvo za sušenje (silika gel) i poliestersku vaticu.
In animal studies it has been shown that elvitegravir, cobicistat, and tenofovir are excreted in milk.
Ispitivanja na životinjama pokazala su da se elvitegravir, kobicistat i tenofovir izlučuju u mlijeko životinja.
No in vitro resistance can be demonstrated with cobicistat due to its lack of antiviral activity.
Nije zapažena in vitro rezistencija za kobicistat zbog nedostatka njegovog antivirusnog djelovanja.
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.
Medijan poluvremena kobicistata u plazmi nakon primjene E/C/F/TDF iznosi oko 3,5 sati, a povezane izloženosti kobicistatu omogućuju Ctrough elvitegravira oko 10 puta višu od prilagođene vrijednosti IC95 vezivanja proteina za divlji tip virusa HIV-1.
Viruses expressing elvitegravir or raltegravir resistance mutations maintain susceptibility to dolutegravir.
Virusi koji izražavaju mutacije povezane s rezistencijom na elvitegravir ili raltegravir zadržavaju osjetljivost na dolutegravir.
HIV-1 isolates with reduced susceptibility to tenofovir alafenamide express a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Izolati virusa HIV-1 sa smanjenom osjetljivošću na tenofoviralafenamid izražavaju mutaciju K65R u HIV-1 RT; dodatno je kratkotrajno uočena i mutacija K70E u HIV-1 RT.
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 = elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat a Okvir 48. tjedna bio je između 294. i 377. dana (uključivo); okvir 144. tjedna bio je između 966. i 1049. dana (uključivo).
The K65R and K70E mutations result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Mutacije K65R i K70E imale su za posljedicu smanjenu osjetljivost na abakavir, didanozin, lamivudin, emtricitabin i tenofovir, ali zadržanu osjetljivost na zidovudin.
Mean % change of elvitegravir pharmacokinetic parametersa
Srednja vrijednost % promjene farmakokinetičkih parametara elvitegraviraa
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
In vitro vezanje emtricitabina za humane proteine plazme bilo je < 4% i nije ovisilo o koncentraciji u rasponu od 0,02-200 µg/ml.
The adverse reactions in Table 2 are listed by system organ class and frequency.
Nuspojave u Tablici 2 navedene su prema klasifikaciji organskih sustava i učestalosti.
Of the 62 patients who were HBV suppressed at baseline, 59 remained suppressed and 3 had missing data.
Od 62 bolesnika koji su imali supresiju HBV-a na početku, 59 ih je zadržalo supresiju, a za 3 bolesnika podaci nisu poznati.
Table 2: Tabulated list of adverse reactions
Tablica 2: Tablični prikaz nuspojava
At the start of treatment with Genvoya, the 72 patients had been HIV suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
Na početku liječenja lijekom Genvoya, 72 bolesnika imali su supresiju HIV-a (HIV-1 RNK < 50 kopija/ml) najmanje 6 mjeseci sa ili bez supresije HBV DNA i imali su kompenziranu funkciju jetre.
The safety of Genvoya has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
Sigurnost lijeka Genvoya nije ustanovljena u bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl ≥ 15 ml/min i < 30 ml/min).
Other medicines and Genvoya Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Plasma concentrations of these medicinal products may be increased when co-administered with Genvoya, resulting in reduced serum cortisol concentrations.
Mogu biti povećane koncentracije tih lijekova u plazmi kada se primjenjuju istodobno s lijekom Genvoya, što dovodi do smanjenih koncentracija kortizola u serumu.
In studies GS-US-292-0104 and GS-US-292-0111, patients were randomised in a 1:1 ratio to receive either Genvoya (n = 866) once daily or elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) (n = 867) once daily.
U ispitivanjima GS-US-292-0104 i GS-US-292-0111 bolesnici su bili randomizirani u omjeru 1:1 kako bi primali lijek Genvoya (n = 866) jednom dnevno ili elvitegravir 150 mg/kobicistat 150 mg/emtricitabin 200 mg/tenofovirdizoproksil (u obliku fumarata) 245 mg (E/C/F/TDF) (n = 867) jednom dnevno.
In a study of Genvoya in HIV-1 infected adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis, efficacy was maintained through 48 weeks but emtricitabine exposure was significantly higher than in patients with normal renal function.
U ispitivanju lijeka Genvoya u odraslih zaraženih virusom HIV-1 sa završnim stadijem bolesti bubrega (procijenjeni CrCl < 15 ml/min) na kroničnoj hemodijalizi, djelotvornost je bila održana tijekom 48 tjedana, ali izloženost emtricitabinu bila je značajno viša nego u bolesnika s normalnom funkcijom bubrega.
Cobicistat was not mutagenic or clastogenic in conventional genotoxicity assays.
Kobicistat nije pokazao mutagenost ni klastogenost u konvencionalnim pretragama genotoksičnosti.
Concomitant use of Genvoya and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Genvoya i kortikosteroida koji se metaboliziraju putem CYP3A (npr. flutikazonpropionata ili drugih inhalacijskih ili nazalnih kortikosteroida) može se povećati rizik od razvoja sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i adrenalnu supresiju.
The hormonal contraceptive should contain at least 30 µg ethinyloestradiol and contain drospirenone or norgestimate as the progestogen or patients should use an alternative reliable method of contraception (see sections 4.4 and
Hormonska kontracepcija mora sadržavati najmanje 30 µg etinilestradiola i mora sadržavati drospirenon ili norgestimat kao progestagen ili bolesnice moraju primjenjivati drugu pouzdanu metodu kontracepcije (vidjeti dijelove 4.4 i 4.6).
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.
Kontraindicirana je istodobna primjena s lijekovima čiji klirens uvelike ovisi o CYP3A i kod kojih su povišene koncentracije u plazmi povezane s ozbiljnim ili životno opasnim nuspojavama.
Tenofovir alafenamide is minimally metabolised by CYP3A4.
Tenofoviralafenamid se minimalno metabolizira pomoću CYP3A4.
• elvitegravir, an antiretroviral medicine known as an integrase inhibitor
• elvitegravir, antiretrovirusni lijek poznat kao inhibitor integraze
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.
Poboljšanja BMD-a bila su opažena 96 tjedana nakon prebacivanja s režima koji sadrži tenofovirdizoproksil na lijek Genvoya u usporedbi s ostankom na režimu koji sadrži tenofovirdizoproksil.
ANTI-INFECTIVES Antifungals
ANTIINFEKTIVNI LIJEKOVI
7 This study was conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in
To je ispitivanje provedeno s dodatnom dozom voksilaprevira od 100 mg kako bi se postigle izloženosti voksilapreviru očekivane u bolesnika zaraženih HCV-om.
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 Ova nuspojava nije uočena u fazi 3 kliničkih ispitivanja lijeka Genvoya ali je prepoznata u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet za emtricitabin kad se koristio s drugim antiretrovirusnim lijekovima.
Co-administration of Genvoya and rifabutin is not recommended.
Ne preporučuje se istodobna primjena lijeka Genvoya i rifabutina.
If you vomit less than 1 hour after taking Genvoya, take another tablet with food.
Ako povratite unutar 1 sata od uzimanja lijeka Genvoya, uzmite drugu tabletu s hranom.
• medicines used to treat gout:
• lijekove koji se primjenjuju za liječenje gihta:
Switching from a tenofovir disoproxil-based regimen to Genvoya was superior in maintaining HIV-1 RNA < 50 copies/mL compared to staying on the baseline regimen (Table 4).
Prebacivanje s režima temeljenog na tenofovirdizoproksilu na lijek Genvoya bilo je superiorno u održavanju HIV-1 RNK < 50 kopija/ml u usporedbi s ostankom na početnom režimu (Tablica 4).
Baseline regimen (n = 477)
(n = 477)