natgillin/translations-raw huggingface dataset:
In Study GS-US-216-0114, hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the cobicistatboosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group, and 97.4% in the ritonavir-boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group through 144 weeks of treatment.
U ispitivanju GS-US-216-0114, hiperbilirubinemija (> 1 x gornja granica normale (GGN)) je bila česta: 97,7% ispitanika u skupini koja je primala kobicistatom pojačani atazanavir s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksilfumarata i 97,4% ispitanika u skupini koja je primala ritonavirom pojačani atazanavir s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksilfumarata tijekom 144 tjedna liječenja.
Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Tybost.
Ne preporučuje se istodobna primjena apiksabana, rivaroksabana ili edoksabana s lijekom Tybost.
No dose adjustment of cobicistat is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B).
Nije potrebna prilagodba doze kobicistata u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre.
 Tell your doctor if you are taking these or any other medicines.
Obavijestite svog liječnika ako uzimate navedene ili bilo koje druge lijekove.
Table 5: Pharmacokinetic parameters [mean ± SD (%CV)] of darunavir 800 mg co-administered with cobicistat 150 mg or ritonavir 100 mg once daily
Tablica 5: Farmakokinetički parametri [srednja vrijednost ± SD (%CV)] darunavira 800 mg istodobno primijenjenog s kobicistatom 150 mg ili ritonavirom 100 mg jednom dnevno
Table 1: Dosing regimens Dose of Tybost
Tablica 1: Režimi doziranja
Propafenone
Propafenon
In an analysis of treatment-failure subjects in Study GS-US-216-0114 through week 144, evaluable genotypic data from paired baseline and treatment-failure isolates were available for all 21 virologic failures in the cobicistat group.
U analizi ispitanika koji nisu odgovorili na liječenje u ispitivanju GS-US-216-0114 kroz 144 tjedana, procjenjivi genotipski podaci iz uparenih početnih izolata i onih koji nisu odgovarali na liječenje bili su dostupni za sve virološke neuspjehe, njih ukupno 21, u skupini koja je primala kobicistat.
Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Tenofovir disoproxil1
Inhibitori nukleozidne reverzne transkriptaze (NRTI) Tenofovirdizoproksil1
Antiviral efficacy data from randomised controlled studies is available for cobicistat-boosted atazanavir, but not for cobicistat-boosted darunavir (see sections 4.4 and 5.2).
Podaci o antivirusnoj djelotvornosti iz randomiziranih kontroliranih ispitivanja dostupni su za kobicistatom pojačani atazanavir, ali ne i za kobicistatom pojačani darunavir (vidjeti dijelove 4.4 i 5.2).
Cobicistat should not be initiated in patients with creatinine clearance less than 70 ml/min if any co-administered agent (e.g. emtricitabine, lamivudine, tenofovir disoproxil, or adefovir) requires dose adjustment based on creatinine clearance.
Primjenu kobicistata se ne smije započinjati u bolesnika s klirensom kreatinina manjim od 70 ml/min ako bilo koji od istodobno primijenjenih lijekova (npr. emtricitabin, lamivudin, tenofovirdizoproksil ili adefovir) zahtijeva prilagodbu doze na osnovi klirensa kreatinina.
Pharmacokinetics of cobicistat have not been fully evaluated in hepatitis B and/or C virus co-infected subjects.
Istodobna infekcija virusom hepatitisa B i/ili hepatitisa C Farmakokinetika kobicistata nije potpuno procijenjena u ispitanika istodobno zaraženih virusom hepatitisa B i/ili C.
Co-administration is not recommended.
Ne preporučuje se istodobna primjena.
Cobicistat co-administered with atazanavir or darunavir should not be used in combination with another antiretroviral agent that requires pharmacoenhancement by means of co-administration with an inhibitor of CYP3A4 to reach the desired therapeutic plasma concentrations (i.e., another protease inhibitor).
Kobicistat istodobno primijenjen s atazanavirom ili darunavirom se ne smije primjenjivati u kombinaciji s drugim antiretrovirusnim lijekom koji zahtijeva farmakokinetičko pojačanje putem istodobne primjene inhibitora CYP3A4 kako bi se dostigle željene terapijske koncentracije u plazmi (npr. drugi inhibitor proteaze).
Co-administration of cobicistat and rifabutin is not recommended.
Ne preporučuje se istodobna primjena kobicistata i rifabutina.
Darunavir given with low dose ritonavir may be considered as an alternative.
Kao alternativa može se razmotriti primjena darunavira s niskom dozom ritonavira.
BOTTLE AND CARTON LABELLING
OZNAČIVANJE NA BOČICI I KUTIJI
nephrolithiasis, haematuria, proteinuria General disorders and administration site conditions: Common:
nefrolitijaza, hematurija, proteinurija Opći poremećaji i reakcije na mjestu primjene: Često:
Co-administration of salmeterol and Tybost is not recommended (see section 4.4).
Ne preporučuje se istodobna primjena salmeterola s lijekom Tybost (vidjeti dio 4.4).
If switching pharmacoenhancer from ritonavir to cobicistat, caution is required during the first two weeks of treatment with Tybost, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer (see section 4.4).
U slučaju prelaska farmakokinetičkog pojačivača s ritonavira na kobicistat, potreban je oprez tijekom prva dva tjedna liječenja lijekom Tybost, posebice ako su doze bilo kojeg od istodobno primijenjenih lijekova titrirane ili prilagođene tijekom primjene ritonavira kao farmakokinetičkog pojačivača (vidjeti dio 4.4).
ANTI-INFECTIVES Antifungals Ketoconazole
Antimikotici Ketokonazol
Darunavir pharmacokinetics parameters
Farmakokinetički parametri darunavira
The safety of cobicistat is based on 144-week data from a phase 3, randomised, active-controlled clinical Study (GS-US-216-0114), in which 692 treatment-naïve patients received at least one dose of cobicistat-boosted atazanavir (n = 344) or ritonavir-boosted atazanavir (n = 348) administered with emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Sigurnost kobicistata temelji se na podacima iz 144. tjedna randomiziranog, djelatnom tvari kontroliranog kliničkog ispitivanja faze 3 (GS-US-216-0114) u kojemu su 692 bolesnika koji prethodno nisu bili liječeni primila najmanje jednu dozu kobicistatom pojačanog atazanavira (n = 344) ili ritonavirom pojačanog atazanavira (n = 348) koji je primijenjen s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksilfumarata.
Viruses were known to be susceptible to atazanavir, emtricitabine and tenofovir disoproxil fumarate at baseline.
Za viruse je početno utvrđeno da su podložni djelovanju atazanavira, emtricitabina i tenofovirdizoproksilfumarata.
No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
Nisu zapažene značajne razlike u farmakokinetici kobicistata između ispitanika s teškim oštećenjem funkcije bubrega i zdravih ispitanika, što je u skladu s niskim bubrežnim klirensom kobicistata.
Table 3: Tabulated summary of adverse reactions to cobicistat-boosted atazanavir based on experience of 144 weeks from phase 3 Study GS-US-216-0114
Tablica 3: Tablični sažetak nuspojava na kobicistatom pojačani atazanavir na temelju iskustva od 144 tjedna iz ispitivanja faze 3 GS-US-216-0114
Increased plasma concentrations of medicinal products that are metabolised by CYP3A (including atazanavir and darunavir) are observed on co-administration with cobicistat.
Povećane plazmatske koncentracije lijekova koji se metaboliziraju putem CYP3A (uključujući atazanavir i darunavir) zapažene su kod istodobne primjene s kobicistatom.
It is unknown whether cobicistat/metabolites are excreted in human milk.
Nije poznato izlučuje li se kobicistat/metaboliti u majčino mlijeko u ljudi.
Co-administration with cobicistat may result in increased sildenafil, tadalafil and vardenafil plasma concentrations, which may result in PDE-5 inhibitorassociated adverse reactions.
Istodobna primjena kobicistata može za posljedicu imati povećane koncentracije sildenafila, tadalafila i vardenafila u plazmi, što može dovesti do nuspojava povezanih s inhibitorom PDE-5.
Concentrations of these sedatives/hypnotics may be increased when co-administered with cobicistat.
Koncentracije ovih sedativa/hipnotika mogu se povećati kod istodobne primjene s kobicistatom.
A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Ispitivanje farmakokinetike kobicistata provedeno je na ispitanicima koji nisu HIV-1 zaraženi, a koji imaju umjereno oštećenje funkcije jetre (Child-Pugh stadij B).
Atazanavir 300 mg once daily Darunavir 800 mg once daily
150 mg jednom dnevno atazanavir 300 mg jednom dnevno darunavir 800 mg jednom dnevno
30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
OBLIK I SADRŽAJ 30 filmom obloženih tableta 90 (3 bočice od 30) filmom obloženih tableta
If switching pharmacoenhancer from ritonavir to cobicistat, caution is required during the first two weeks of treatment with cobicistat, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer (see section 4.5).
U slučaju zamjene farmakokinetičkog pojačivača s ritonavira na kobicistat, oprez je potreban tijekom prva dva tjedna liječenja kobicistatom, posebice ako su doze bilo kojeg od istodobno primijenjenih lijekova titrirane ili prilagođene tijekom primjene ritonavira kao farmakokinetičkog pojačivača (vidjeti dio 4.5).
Tybost contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Tybost sadrži azo bojilo sunset yellow FCF (E110), koje može uzrokovati alergijske reakcije.
Consult the Summary of Product Characteristics of atazanavir or darunavir for further information on use in combination with these medicinal products.
Savjetuje se proučiti sažetak opisa svojstava lijeka za atazanavir ili darunavir za više informacija o primjeni u kombinaciji s ovim lijekovima.
Tybost is used in combination with atazanavir or darunavir, therefore the atazanavir or darunavir Summary of Product Characteristics should be consulted.
Tybost se primjenjuje u kombinaciji s atazanavirom ili darunavirom, stoga je potrebno proučiti sažetak opisa svojstava lijeka atazanavira ili darunavira.
The mean (± SD) change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was -15.1 ± 16.5 ml/min in the cobicistat-boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group and -8.0 ± 16.8 ml/min in the ritonavir-boosted atazanavir plus emtricitabine and tenofovir disoproxil fumarate fixed-dose combination group.
Srednja vrijednost (± SD) promjene procijenjene brzine glomerularne filtracije (eGFR) izračunate metodom Cockcroft-Gault nakon 144 tjedna liječenja iznosila je -15,1 ± 16,5 ml/min u skupini koja je primala kobicistatom pojačani atazanavir s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksilfumarata i -8,0 ± 16,8 ml/min u skupini koja je primala ritonavirom pojačan atazanavir s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksilfumarata.
Co-administration of salmeterol with cobicistat may result in increased plasma concentrations of salmeterol.
Istodobna primjena salmeterola i kobicistata može za posljedicu imati povećane koncentracije salmeterola u plazmi.
The effect of cobicistat on atazanavir pharmacokinetics was demonstrated in the pharmacokinetic substudy (n = 48) of the phase 3 Study GS-US-216-0114 in which HIV-1 infected patients received atazanavir 300 mg + cobicistat 150 mg or atazanavir 300 mg + ritonavir 100 mg, both in combination with emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Učinak kobicistata na farmakokinetiku atazanavira dokazan je u farmakokinetičkom podispitivanju (n = 48) ispitivanja faze 3 GS-US-216-0114 u kojem su HIV-1 zaraženi bolesnici primali atazanavir 300 mg + kobicistat 150 mg ili atazanavir 300 mg + ritonavir 100 mg, oba u kombinaciji s kombinacijom fiksne doze emtricitabina i tenofovirdizoproksilfumarata.
K65R or K70E, or any primary resistance substitution associated with protease inhibitors.
Nijedan ispitanik nije razvio s tenofovirom povezanu rezistentnu supstituciju K65R, ili K70E, ili bilo koje druge primarne rezistentne supstitucije povezane s inhibitorima proteaze.
Tybost contains the active substance cobicistat.
Tybost sadrži djelatnu tvar kobicistat.
Atazanavir pharmacokinetics parameters
Farmakokinetički parametri atazanavira
• vomiting, diarrhoea, stomach pain, problems with digestion resulting in pain after meals
• povraćanje, proljev, bol u trbuhu, problemi s probavom koji za posljedicu imaju bolove nakon obroka (dispepsija), osjećaj nadutosti, vjetrovi (flatulencija)
Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Kobicistat se metabolizira putem oksidacije posredovane CYP3A (glavni put) i CYP2D6 (sporedni put) te ne prolazi glukuronidaciju.
Tybost 150 mg film-coated tablets
Tybost 150 mg filmom obložene tablete kobicistat
HMG Co-A REDUCTASE INHIBITORS Fluvastatin
INHIBITORI REDUKTAZE HMG-CoA
Co-administration of cobicistat with dabigatran is contraindicated.
Istodobna primjena kobicistata s dabigatranom je kontraindicirana.
No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za kobicistat.
Co-administration with cobicistat can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.4).
Istodobna primjena s kobicistatom može povećati plazmatske koncentracije lijekova koje metabolizira CYP2D6 (vidjeti dijelove 4.3 i 4.4).
Digoxin (0.5 mg single dose)/Cobicistat (150 mg multiple doses)
Digoksin (jedna doza od 0,5 mg) / kobicistat (više doza od 150 mg)
The safety and efficacy of cobicistat with atazanavir in HIV-1 infected patients were evaluated in the randomised, double-blind, active-controlled phase 3 Study GS-US-216-0114 in HIV-1 infected patients with baseline estimated creatinine clearance above 70 ml/min who were treatment-naïve (n = 692).
U bolesnika zaraženih virusom HIV-1 koji nisu prije liječeni Sigurnost i djelotvornost kobicistata s atazanavirom u bolesnika zaraženih HIV-1 procijenjene su u randomiziranom, dvostruko slijepom, djelatnom tvari kontroliranom ispitivanju faze 3 GS-US-216-0114 u HIV-1 zaraženih bolesnika s procijenjenom početnom vrijednošću klirensa kreatinina iznad 70 ml/min koji nisu prije bili liječeni (n = 692).
You must remain under the care of your doctor while taking Tybost.
Za vrijeme uzimanja lijeka Tybost morate ostati pod skrbi svog liječnika.
Plasma concentrations of HMG Co-A reductase inhibitors may be increased when co-administered with cobicistat.
Koncentracije inhibitora reduktaze HMG-CoA u plazmi mogu se povećati kod istodobne primjene s kobicistatom.
Changes in CD4+ cell counts through 48 and 144 weeks in Study GS-US-216-0114 are presented in Table 8.
Promjene broja CD4+ stanica kroz 48 tjedana odnosno 144 tjedna ispitivanja GS-US-216-0114 prikazane su u tablici 8.
See sections 4.2, 4.4, 5.1 and 5.2.
Vidjeti dijelove 4.2, 4.4, 5.1 i 5.2. 4.2 Doziranje i način primjene
No clinically relevant pharmacokinetic differences due to ethnicity have been identified for cobicistat.
Klinički značajne farmakokinetičke razlike vezane uz etničku pripadnost nisu ustanovljene za kobicistat.
Concentrations of ketoconazole and/or cobicistat may increase with co-administration of cobicistat.
Koncentracije ketokonazola i/ili kobicistata mogu se povećati s istodobnom primjenom kobicistata.
The active substance is cobicistat.
Djelatna tvar je kobicistat.
Concentrations of voriconazole may increase or decrease when co-administered with cobicistat.
Koncentracije vorikonazola mogu se povećati ili smanjiti s istodobnom primjenom kobicistata.
Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.
Koncentracije itrakonazola, flukonazola i pozakonazola mogu se povećati s istodobnom primjenom kobicistata.
You should not take Tybost with other medicines containing:
Lijekovi koji se primjenjuju za liječenje infekcije HIV-om: Ne smijete uzimati Tybost s drugim lijekovima koji sadrže:
Buprenorphine/Naloxone
Buprenorfin/nalokson
Co-administration of cobicistat with medicinal products that inhibit CYP3A may decrease the clearance of cobicistat, resulting in increased cobicistat plasma concentrations (see section 4.5).
Istodobna primjena kobicistata s lijekovima koji inhibiraju CYP3A može smanjiti klirens kobicistata, što može za posljedicu imati povećane koncentracije kobicistata u plazmi (vidjeti dio 4.5).
No dose adjustment of cobicistat is required.
Nije potrebna prilagodba doze kobicistata.
• nevirapine
• nevirapin
Missing data during window but on study drug a Week 48 window is between day 309 and 378 (inclusive) b Week 144 window is between day 967 and 1,050 (inclusive) c Includes subjects who had ≥ 50 copies/ml in the week 48 or 144 windows; subjects who discontinued early due to lack or loss of efficacy; subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy, and at the time of discontinuation had a viral value of ≥ 50 copies/ml.
c Obuhvaća ispitanike koji su imali ≥ 50 kopija/ml u okviru 48. ili 144. tjedna, ispitanike s ranim prekidom zbog nedostatka ili gubitka djelotvornosti, ispitanike koji su prekinuli iz razloga koji nisu posljedica nuspojave, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida imali virusnu vrijednost
For additional drug-drug interactions with atazanavir or darunavir, consult their respective Summary of Product Characteristics when using Tybost.
Za dodatne interakcije između lijekova s atazanavirom ili darunavirom potrebno je proučiti njihov sažetak opisa svojstava lijeka kad se primjenjuju istodobno s lijekom Tybost.
Co-administration with cobicistat can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.5).
Istodobna primjena s kobicistatom može povećati koncentracije lijekova u plazmi koje metabolizira CYP2D6 (vidjeti dijelove 4.3 i 4.5).
Co-administration of cobicistat with carbamazepine is contraindicated (see section 4.3).
Istodobna primjena kobicistata i karbamazepina je kontraindicirana (vidjeti dio 4.3).
Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Tybost.
U bolesnika koji uzimaju Tybost preporučuju se pažljivi nadzor bolesnika i prilagodba doze metformina.
Concentrations of calcium channel blockers may be increased when co-administered with cobicistat.
Koncentracije blokatora kalcijevih kanala mogu se povećati kod istodobne primjene s kobicistatom.
Nevirapine
Nevirapin
Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Kobicistat nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
No dose adjustment of cobicistat is necessary for patients with mild to moderate hepatic impairment.
Nije potrebna prilagodba doze kobicistata za bolesnike s blagim do umjerenim oštećenjem funkcije jetre.
Co-administration of cobicistat with medicinal products that are strong inducers of CYP3A (such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital, phenytoin) may result in decreased plasma concentrations of cobicistat and consequently that of atazanavir or darunavir being boosted, leading to loss of therapeutic effect and possible development of resistance (see section 4.3).
Istodobna primjena kobicistata i lijekova koji su jaki induktori CYP3A (kao što su gospina trava [Hypericum perforatum], rifampicin, karbamazepin, fenobarbital i fenitoin), može za posljedicu imati smanjene plazmatske koncentracije kobicistata te posljedično smanjenja pojačanja atazanavira ili darunavira, što dovodi do gubitka terapijskog učinka i mogućeg razvoja rezistencije (vidjeti dio 4.3).
No clinically relevant differences in cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Nisu zapažene klinički značajne razlike u farmakokinetici kobicistata između ispitanika s umjerenim oštećenjem funkcije jetre i zdravih ispitanika.
In clinical studies, cobicistat was co-administered with atazanavir or darunavir under fed conditions, in accordance with the Summary of Product Characteristics for these agents.
U kliničkim ispitivanjima, kobicistat je istodobno primjenjivan s atazanavirom ili darunavirom na puni želudac u skladu sa sažetkom opisa svojstava za te lijekove.
Co-administration of neuroleptics with cobicistat may result in increased plasma concentrations of neuroleptics.
Istodobna primjena neuroleptika s kobicistatom može za posljedicu imati povećane koncentracije neuroleptika u plazmi.
insomnia, abnormal dreams
nesanica, poremećeni snovi
For more information on the side effects of atazanavir or darunavir see the package leaflets for these medicines.
Za više informacija o nuspojavama atazanavira ili darunavira proučite uputu o lijeku za te lijekove.
When clarithromycin is co-administered with darunavir/cobicistat, consult the darunavir Summary of Product Characteristics for dosing recommendations.
Kad se klaritromicin primjenjuje istodobno s darunavirom/kobicistatom proučiti sažetak opisa svojstava darunavira za preporuke o doziranju.
The steady-state pharmacokinetic parameters of darunavir were comparable when boosted with cobicistat versus ritonavir (see Table 5).
Farmakokinetički parametri u stanju dinamičke ravnoteže darunavira pojačanog kobicistatom bili su usporedivi s ritonavirom (vidjeti Tablicu 5).
Atazanavir or darunavir plasma concentrations may decrease as a consequence of a reduction in cobicistat plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Koncentracije atazanavira ili darunavira u plazmi mogu se smanjiti kao posljedica redukcije koncentracija kobicistata u plazmi što može uzrokovati gubitak terapijskog učinka i razvoj rezistencije.
CD4+ T-cell count (cells/mm3)b a Plus background regimen of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed-dose combination b Missing = excluded analysis
CD4+ T-stanica od početne vrijednosti (stanica/mm3)b a Plus pozadinski režim kombinacije fiksne doze emtricitabina 200 mg i tenofovirdizoproksilfumarata 300 mg b Nedostaju = isključena analiza
AUCtau (µg•h/ml) Cmax (µg/ml) Ctau (µg/ml) a Plus background regimen of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed-dose combination
AUCtau (µg•h/ml) Cmax (µg/ml) Ctau (µg/ml) a Plus pozadinski režim kombinacije fiksne doze emtricitabina 200 mg i tenofovirdizoproksilfumarata 300 mg
Carbamazepine, a potent CYP3A inducer, decreases cobicistat plasma concentrations and that of atazanavir or darunavir, which may result in loss of therapeutic effect and development of resistance.
Karbamazepin, potentni induktor enzima CYP3A, smanjuje koncentracije kobicistata u plazmi, kao i koncentracije atazanavira ili darunavira, što može uzrokovati gubitak terapijskog učinka i razvoj rezistencije.
Alternative antibiotics should be considered for co-administration with atazanavir/cobicistat.
Potrebno je razmotriti istodobnu primjenu drugih antibiotika s atazanavirom/kobicistatom.
Co-administration of rilpivirine and cobicistat is expected to increase the plasma concentration of rilpivirine.
Očekuje se da će istodobna primjena rilpivirina i kobicistata povećati koncentraciju rilpivirina u plazmi.
Itraconazole Voriconazole Posaconazole Fluconazole
Itrakonazol Vorikonazol Pozakonazol Flukonazol
Carbamazepine-10,11-epoxide:
Karbamazepin-10,11-epoksid: AUC: ↓ 35%
Etravirine
Etravirin