natgillin/translations-raw huggingface dataset:
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 začetku zdravljenja z zdravilom Genvoya je imelo 72 bolnikov vsaj 6 mesecev supresijo HIV (HIV-1 RNA < 50 kopij/ml) s supresijo HBV DNA ali brez nje in kompenzirano jetrno funkcijo.
High density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets.
Plastenka iz polietilena visoke gostote (HDPE), s polipropilensko, za otroke varno zaporko z neprekinjeno nitko, obloženo z indukcijsko aktivirano aluminijasto folijo, ki vsebuje 30 filmsko obloženih tablet.
Sofosbuvir metabolite GS-566500:
presnovek sofosbuvirja GS-566500: AUC: ↔
If the patient misses a dose of Genvoya within 18 hours of the time it is usually taken, the patient should take Genvoya with food as soon as possible and resume the normal dosing schedule.
Če bolnik izpusti odmerek zdravila Genvoya v roku 18 ur od časa, ko ga običajno vzame, naj vzame zdravilo Genvoya s hrano takoj, ko je mogoče, nato pa nadaljuje z običajnim režimom odmerjanja.
The safety and efficacy of Genvoya in patients with significant underlying liver disorders have not been established.
Varnost in učinkovitost zdravila Genvoya pri bolnikih s pomembnejšimi sočasnimi jetrnimi boleznimi nista bili dokazani.
The median increase from baseline for those parameters was greater in the Genvoya group compared with the E/C/F/TDF group at Week 144 (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
V 144. tednu je bilo mediano povečanje začetne vrednosti za te parametre večje v skupini z zdravilom Genvoya v primerjavi s skupino z E/C/F/TDF (p < 0,001 za razliko med skupinama zdravljenja za skupni holesterol na tešče, direktni LDL in HDL holesterol in trigliceride).
Fifteen percent of patients identified as Hispanic/Latino.
Petnajst odstotkov bolnikov je bilo opredeljenih kot španskega/latinskoameriškega porekla.
(38.9)b N/A
(38,9)b n/v 10,0
Genvoya should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Zdravljenje z zdravilom Genvoya je treba prekiniti pri bolnikih z ocenjenim CrCl, ki med zdravljenjem pade pod 30 ml/min (glejte poglavje 5.2).
Cobicistat is 97-98% bound to human plasma proteins and the mean plasma to blood drug concentration ratio was 2.
Kobicistat se 97-98 % veže na plazemske proteine, povprečno razmerje med koncentracijo zdravila v plazmi in krvi pa je bilo 2.
Elvitegravir undergoes primarily oxidative metabolism via CYP3A, and is secondarily glucuronidated via UGT1A1/3 enzymes.
Elvitegravir se pretežno presnavlja z oksidacijo s pomočjo CYP3A in sekundarno z glukuronidacijo s pomočjo encimov UGT1A1/3.
The safety of Genvoya has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
Učinkovitost in varnost zdravila Genvoya pri bolnikih s hudo ledvično okvaro (ocenjeni CrCl ≥ 15 ml/min in < 30 ml/min) nista bili dokazani.
Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Tenofoviralafenamid ni zaviralec CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali CYP2D6.
Following oral administration of [14C]-cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Po peroralnem dajanju [14C]kobicistata je bilo 99 % cirkulirajoče radioaktivnosti v plazmi nespremenjeni kobicistat.
c Includes patients who had ≥ 50 copies/mL in the Week 48 or 144 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
c Vključuje bolnike, ki so imeli v oknu 48. ali 144. tedna ≥ 50 kopij/ml; bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka, bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
diarrhoea, vomiting, abdominal pain, flatulence
driska, bruhanje, bolečine v trebuhu, flatulenca
However, upon co-administration with cobicistat in Genvoya, near maximal inhibition of P-gp by cobicistat is achieved leading to increased availability of tenofovir alafenamide with resulting exposures comparable to tenofovir alafenamide 25 mg administered alone.
Vendar pa sočasno dajanje kobicistata z zdravilom Genvoya povzroči, da kobicistat skoraj maksimalno zavira P-gp, kar povzroči povečano razpoložljivost tenofoviralafenamida, zato je posledično izpostavljenost primerljiva s tenofoviralafenamidom 25 mg, ko se ga daje samega.
It is not known whether cobicistat, emtricitabine, or tenofovir alafenamide are inhibitors of other UGT enzymes.
Ni znano, ali so kobicistat, emtricitabin ali tenofoviralafenamid zaviralci drugih encimov UGT.
Following administration of [14C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (~86%) and faeces (~14%).
Po dajanju [14C]emtricitabina so celotni odmerek emtricitabina izolirali iz urina (~ 86 %) in blata (~ 14 %).
No dose adjustment of Genvoya is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Odmerka zdravila Genvoya ni treba prilagoditi pri bolnikih z blago (stopnje A po Child-Pughu) ali zmerno (stopnje B po Child-Pughu) jetrno okvaro.
Medicinal products that inhibit CYP3A may decrease the clearance of cobicistat, resulting in increased plasma concentrations of cobicistat.
Zdravila, ki zavirajo CYP3A, lahko zmanjšajo očistek kobicistata, kar povzroči zvišanje koncentracij kobicistata v plazmi.
Carbamazepine decreases plasma concentrations of elvitegravir and cobicistat, which may result in loss of therapeutic effect and development of resistance.
Karbamazepin zmanjšuje koncentracije elvitegravirja in kobicistata v plazmi, kar lahko povzroči izgubo terapevtskega učinka in razvoj rezistence.
Non-clinical studies of tenofovir alafenamide in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Predklinične študije tenofoviralafenamida pri podganah in psih so pokazale, da sta primarna ciljna organa toksičnosti kosti in ledvice.
Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chain-termination.
Tenofovir difosfat zavira podvajanje HIV z vgraditvijo v virusno DNA z RT HIV, kar povzroči prekinitev verige DNA.
Following oral administration of boosted [14C]-elvitegravir, elvitegravir was the predominant species in plasma, representing ~94% of the circulating radioactivity.
Po peroralnem dajanju ojačanega [14C]elvitegravirja je bil elvitegravir prevladujoča vrsta v plazmi in je predstavljal ~94 % cirkulirajoče radioaktivnosti.
The median (Q1, Q3) change from baseline in total cholesterol to HDL-cholesterol ratio at Week 144 was 0.2 (-0.3, 0.7) in the Genvoya group and 0.1 (-0.4, 0.6) in the E/C/F/TDF group (p = 0.006 for the difference between treatment groups).
Mediana (Q1, Q3) sprememba od začetne vrednosti za razmerje med skupnim holesterolom in HDL holesterolom v 144. tednu je bila 0,2 (-0,3; 0,7) v skupini z zdravilom Genvoya in 0,1 (-0,4; 0,6) v skupini z E/C/F/TDF (p = 0,006 za razliko med skupinama zdravljenja).
Female patients of childbearing potential should use either a hormonal contraceptive containing at least 30 µg ethinyloestradiol and containing drospirenone or norgestimate as the progestogen or should use an alternative reliable method of contraception (see sections 4.5 and 4.6).
Bolnice v rodni dobi morajo uporabljati bodisi hormonsko kontracepcijo, ki vsebuje vsaj 30 µg etinilestradiola in ki vsebuje drospirenon ali norgestimat kot progestogen, ali pa morajo uporabljati drugo zanesljivo metodo kontracepcije (glejte poglavji 4.5 in 4.6).
Genvoya should generally be avoided but may be used in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Zdravilu Genvoya se je treba načeloma izogniti, a se lahko uporablja pri odraslih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi, če so možne koristi večje od možnih tveganj (glejte poglavje 4.2).
In studies in treatment-naïve patients, increases from baseline were observed in both treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
V študijah pri predhodno nezdravljenih bolnikih so v 144. tednu povečanje od začetne vrednosti opazili v obeh skupinah zdravljenja pri parametrih maščob na tešče za skupni holesterol, direktni holesterol lipoproteinov nizke gostote (LDL- low-density lipoprotein) ali LDL holesterol, holesterol lipoproteinov visoke gostote (HDL- high-density lipoprotein) ali HDL holesterol in trigliceride.
Then take the next dose as usual.
Nato vzemite naslednji odmerek z obrokom ob svojem običajnem času.
Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Po sočasnem dajanju z efavirenzom, testnim zmernim induktorjem CYP3A, ni bilo značilnega vpliva na izpostavljenost tenofoviralafenamidu.
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.
Sočasna uporaba zdravila Genvoya in kortikosteroidov, ki se presnavljajo s pomočjo encimov CYP3A (npr. flutikazonpropionat in drugi inhalacijski ali nazalni kortikosteroidi), lahko poveča tveganje za razvoj sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in supresijo nadledvičnih žlez.
Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may result in increased plasma concentrations of these products, which are associated with the potential for serious or life-threatening adverse reactions such as peripheral vasospasm or ischaemia (e.g., dihydroergotamine, ergotamine, ergometrine), or myopathy, including rhabdomyolysis (e.g., simvastatin, lovastatin), or prolonged or increased sedation or respiratory depression (e.g., orally administered midazolam or triazolam).
Sočasna uporaba zdravila Genvoya in nekaterih zdravil, ki se pretežno presnavljajo s CYP3A, lahko povzroči zvišane koncentracije teh zdravil v plazmi, kar je povezano z možnimi resnimi ali življenjsko nevarnimi neželenimi učinki, kot so periferni vazospazem ali ishemija (npr. dihidroergotamin, ergotamin, ergometrin) ali miopatija, vključno z rabdomiolizo (npr. simvastatin, lovastatin), ali podaljšanjem oz. povečanjem sedacije ali respiratorne depresije (npr. peroralno dan midazolam ali triazolam).
Table 4: Virologic outcomes of Study GS-US-292-0109 at Weeks 48a and 96b
Preglednica 4: Virološki izidi študije GS-US-292-0109 v 48. tednua in 96. tednub
No dose adjustment of clarithromycin is required.
Prilagoditev odmerka klaritromicina ni potrebna.
There are no data on fertility from the use of Genvoya in humans.
Podatkov o učinkih uporabe zdravila Genvoya na sposobnost razmnoževanja pri ljudeh ni.
d Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 96 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
d Vključuje bolnike, ki so imeli v oknu 48. tedna ali 96. tedna ≥ 50 kopij/ml; bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka, bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
Thirteen percent of patients were identified as Hispanic/Latino.
Trinajst odstotkov bolnikov je bilo opredeljenih kot španskega/latinskoameriškega porekla.
In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by cathepsin A in PBMCs (including lymphocytes and other HIV target cells) and macrophages; and by carboxylesterase-1 in hepatocytes.
Študije in vitro so pokazale, da se tenofoviralafenamid presnavlja v tenofovir (glavni presnovek) s pomočjo katepsina A v PBMC (vključno z limfociti in drugimi ciljnimi celicami HIV) in makrofagih ter s karboksilesterazo-1 v hepatocitih.
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.
V študiji zdravila Genvoya pri odraslih z okužbo HIV-1 s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi se je učinkovitost ohranila do konca 48. tedna, vendar je bila izpostavljenost emtricitabinu značilno večja kot pri bolnikih z normalnim delovanjem ledvic.
cisapride (used to relieve certain stomach problems) St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it lovastatin, simvastatin (used to lower blood cholesterol) pimozide, lurasidone (used to treat abnormal thoughts or feelings) sildenafil (when used to treat pulmonary arterial hypertension - a lung disease that makes breathing difficult) orally administered midazolam, triazolam (used to help you sleep and/or relieve anxiety)
lovastatin, simvastatin (uporabljata se za nižanje holesterola v krvi) pimozid, lurasidon (uporabljata se za zdravljenje nenormalnih misli ali občutkov) sildenafil (ko se uporablja za zdravljenje pljučne arterijske hipertenzije - bolezni pljuč, ki otežuje dihanje) peroralno uporabljen midazolam, triazolam (uporabljata se kot pomoč pri spanju in/ali za lajšanje tesnobe)
Studies of tenofovir alafenamide in animals have shown no evidence of harmful effects of tenofovir alafenamide on fertility parameters, pregnancy, or foetal development (see section 5.3).
Študije tenofoviralafenamid na živalih niso pokazale škodljivih učinkov tenofoviralafenamid na parametre plodnosti, nosečnost ali razvoj plodu (glejte poglavje 5.3).
Black
Črnci
d Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
d Vključuje bolnike, ki so prenehali sodelovati zaradi neželenih učinkov ali smrti, kadar koli od 1. dne do časovnega okna, če zaradi tega v določenem oknu ni bilo viroloških podatkov o zdravljenju.
In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
In vitro je bila vezava tenofovirata na humane plazemske proteine < 0,7 % in je neodvisna od koncentracije v razponu med 0,01-25 μg/ml.
Genvoya can cause dizziness.
Zdravilo Genvoya lahko povzroči omotičnost.
• HMG Co-A reductase inhibitors: lovastatin, simvastatin
• učinkovine za gastrointestinalno gibljivost: cisaprid • zaviralci HMG Co-A reduktaze: lovastatin, simvastatin
Voriconazole3 Posaconazole3 Fluconazole
itrakonazol3 vorikonazol3 posakonazol3
Co-administration of Genvoya and other medicinal products primarily metabolised by CYP3A such as amiodarone, quinidine, cisapride, pimozide, lurasidone, alfuzosin and sildenafil for pulmonary arterial hypertension is contraindicated (see section 4.3).
Sočasna uporaba zdravila Genvoya in drugih zdravil, ki jih pretežno presnavlja CYP3A, kot so amiodaron, kinidin, cisaprid, pimozid, lurasidon, alfuzosin in sildenafil za pljučno arterijsko hipertenzijo, je kontraindicirana (glejte poglavje 4.3).
Voxilaprevir:
voksilaprevir:
Co-administration of Genvoya and sildenafil for the treatment of pulmonary arterial hypertension is contraindicated.
Sočasno dajanje zdravila Genvoya in sildenafila za zdravljenje pljučne arterijske hipertenzije je kontraindicirano.
Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at concentrations at least 11-fold higher than the human exposure at the recommended 150 mg daily dose.
Študije pri kuncih ex vivo in pri psih in vivo kažejo, da ima kobicistat nizek potencial za podaljšanje intervala QT in da lahko nekoliko podaljša interval PR ter zmanjša delovanje levega prekata pri koncentracijah, ki so vsaj
e Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
e Vključuje bolnike, ki so prenehali sodelovati zaradi neželenih učinkov ali smrti, kadar koli od 1. dne do časovnega okna, če zaradi tega v določenem oknu ni bilo viroloških podatkov o zdravljenju.
Elvitegravir is 98-99% bound to human plasma proteins and binding is independent of drug concentration over the range of 1 ng/mL to 1.6 µg/mL.
Elvitegravir se 98-99 % veže na humane plazemske proteine, pri čemer vezava ni odvisna od koncentracije zdravila v razponu od 1 ng/ml do 1,6 µg/ml.
Nineteen percent of patients were identified as Hispanic/Latino.
Devetnajst odstotkov bolnikov je bilo opredeljenih kot španskega/latinskoameriškega porekla.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment.
Pri ugotovljeni imunski reaktivaciji so poročali tudi o pojavu avtoimunskih bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis), vendar pa je poročani čas do njihovega pojava bolj variabilen in se ti dogodki lahko pojavijo več mesecev po uvedbi zdravljenja.
Cobicistat is a strong mechanism-based inhibitor of CYP3A and is also a CYP3A substrate.
Kobicistat je močan zaviralec encimskega mehanizma CYP3A in tudi substrat CYP3A.
Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received Genvoya 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 zdravilo Genvoya v študiji GS-US-292-1825, so bile značilno večje kot pri bolnikih z normalnim delovanjem ledvic.
Co-administration of Genvoya and rifabutin is not recommended.
Sočasno dajanje zdravila Genvoya in rifabutina se ne priporoča.
If the patient vomits within 1 hour of taking Genvoya another tablet should be taken.
Če bolnik v roku 1 ure od jemanja zdravila Genvoya bruha, naj vzame drugo tableto.
• elvitegravir, an antiretroviral medicine known as an integrase inhibitor
• elvitegravir, protiretrovirusno zdravilo, znano kot zaviralec integraze
Seventy-six percent were male, 82% were Black and 18% were White.
Šestinsedemdeset odstotkov je bilo moških, 82 % je bilo črncev in 18 % je bilo belcev.
All corticosteroids excluding cutaneous products Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Vsi kortikosteroidi razen izdelkov za kožo Kortikosteroidi, ki se primarno presnavljajo s pomočjo encimov CYP3A (vključno z betametazonom, budezonidom, flutikazonom, mometazonom,
In a clinical study of HIV virologically suppressed patients co-infected with chronic hepatitis B, who received Genvoya for 48 weeks (GS-US-292-1249, n = 72), 2 patients qualified for resistance analysis.
V klinični študiji z bolniki z virološko supresijo s HIV in sočasno okužbo s kroničnim hepatitisom B, ki so 48 tednov prejemali zdravilo Genvoya, (GS-US-292-1249, n = 72), sta bila 2 bolnika primerna za analizo rezistence.
Patients in Cohort 2 had a mean age of 10 years (range: 8 to 11), a mean baseline weight of 32 kg (range: 26 to 58), were 39% male, 13% Asian, and 78% Black.
Povprečna starost bolnikov v kohorti 2 je bila 10 let (razpon: 8 do 11 let), povprečna izhodiščna telesna masa 32 kg (razpon: 26 do 58 kg), 39 % je bilo moških, 13 % Azijcev in 78 % črncev.
Mean % change of cobicistat pharmacokinetic parametersa
Povprečni % spremembe farmakokinetičnih parametrov za kobicistata
Patients in the study had a median age of 15 years (range: 12 to 17 years), 64% were female and 98% were Black.
Mediana starost bolnikov v tej študiji je bila 15 let (razpon: od 12 do 17 let), 64 % jih je bilo ženskega spola in 98 % je bilo črncev.
Clarithromycin dosing should be based on the patient's CrCl, taking into consideration the effect of cobicistat on CrCl and serum creatinine (see section 4.8).
CrCl, pri čemer je treba upoštevati učinek kobicistata na vrednost CrCl in kreatinina v serumu (glejte poglavje 4.8).
5.4% (95% CI: 1.5% to 9.2%)
5,4 % (95-% IZ: 1,5 % do 9,2 %)
Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Presnova je glavna pot izločanja tenofoviralafenamid pri ljudeh in predstavlja > 80 % peroralnega odmerka.
The mean baseline plasma HIV-1 RNA was 4.5 log10 copies/mL (range 1.3-7.0) and 23% had baseline viral loads > 100,000 copies/mL.
Povprečna začetna vrednost HIV-1 RNA v plazmi je bila 4,5 log10 kopij/ml (razpon 1,3-7,0) in 23 % jih je imelo začetno virusno obremenitev > 100.000 kopij/ml.
On days of haemodialysis, Genvoya should be administered after completion of haemodialysis treatment.
Ob dneh hemodialize je treba zdravilo Genvoya dati po koncu zdravljenja s hemodializo.
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving Genvoya (see section 4.8).
Novih varnostnih vprašanj pri bolnikih s končno ledvično odpovedjo na kronični hemodializi, ki so prejemali zdravilo Genvoya, niso prepoznali (glejte poglavje 4.8).
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
Hormonski kontraceptiv mora vsebovati vsaj 30 µg etinilestradiola in drospirenon ali norgestimat kot progestogen, ali pa morajo bolnice uporabljati drugo zanesljivo metodo kontracepcije (glejte poglavji 4.4 in 4.6).
In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite tenofovir diphosphate.
In vivo se tenofoviralafenamid hidrolizira v celicah v tenofovir (glavni presnovek), ki se fosforilizira v aktivni presnovek tenofovir difosfat.
Adolescents and children 6 years of age and older, who weigh at least 25 kg: one tablet each day with food
Mladostniki in otroci, stari 6 let ali več, s telesno maso vsaj 25 kg: ena tableta vsak dan s hrano Tablete ne žvečite ali drobite.
90 (3 bottles of 30) film-coated tablets 90 (3 bottles of 30) tablets
90 (3 plastenke po 30) tablet
Norelgestromin:
norgestromin:
Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Kobicistat se presnavlja z oksidacijo, v kateri posredujeta (glavni) CYP3A in (manj pomembni) CYP2D6, in se ne glukuronidira.
Patients with CrCl between 30 mL/min and 60 mL/min:
Bolniki s CrCl med 30 ml/min in
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).
Prehod z režima na podlagi dizoproksiltenofovirata na zdravilo Genvoya je bil boljši pri ohranjanju HIV-1 RNA < 50 kopij/ml v primerjavi z bolniki, ki so ostali na začetnem režimu (preglednica 4).