natgillin/translations-raw huggingface dataset:
Rilpivirine is not expected to affect the plasma concentration of cobicistat. 
Ne očekuje se da će rilpivirin utjecati na koncentraciju kobicistata u plazmi.
There are limited data from the use of cobicistat and atazanavir in pregnant women. 
Podaci o primjeni kobicistata i atazanavira u trudnica su ograničeni.
Treatment with cobicistat and darunavir during the second and third trimesters of pregnancy has been shown to result in lower darunavir exposure compared to postpartum. 
Pokazalo se da liječenje kobicistatom i darunavirom tijekom drugog i trećeg tromjesečja trudnoće rezultira manjom izloženošću darunaviru u usporedbi s onom nakon porođaja.
Week 144b 
144. tjedanb
Medicinal products that are extensively metabolised by CYP3A and have high first pass metabolism appear to be the most susceptible to large increases in exposure when co-administered with cobicistat. 
Čini se da su lijekovi koji se opsežno metaboliziraju putem enzima CYP3A i podliježu visokom metabolizmu prvog prolaska najpodložniji većim povećanjima u ekspoziciji kad se istodobno primjenjuju s kobicistatom.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets. 
Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bočicu s 30 filmom obloženih tableta i 90 (3 bočice od 30) filmom obloženih tableta.
hyperglycaemia, increased appetite Psychiatric disorders: 
hiperglikemija, povećan apetit Psihijatrijski poremećaji: Često:
• antiarrhythmics: amiodarone, quinidine 
• antiaritmici: amiodaron, kinidin
• metformin, medicine used for the treatment of type 2 diabetes 
• metformin, lijek koji se primjenjuje za liječenje šećerne bolesti tipa 2
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 and/or life-threatening events. 
Kontraindicirana je istodobna primjena s lijekovima čiji klirens uvelike ovisi o CYP3A i kod kojih su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima.
Therefore, the use of Tybost is not recommended in these patients (see sections 4.2 and 5.2). 
Stoga se primjena lijeka Tybost ne preporučuje u tih bolesnika (vidjeti dijelove 4.2 i 5.2).
• another protease inhibitor 
• drugi inhibitor proteaze
The most frequently reported adverse reactions to cobicistat-boosted atazanavir were associated with elevated bilirubin levels (see Table 3). 
Najčešće prijavljivane nuspojave na kobicistatom pojačani atazanavir bile su povezane s povišenim razinama bilirubina (vidjeti Tablicu 3).
Higher plasma concentrations of co-administered medicinal products can result in increased or prolonged therapeutic effects or adverse reactions. 
Više koncentracije istodobno primijenjenih lijekova u plazmi mogu za posljedicu imati povećane ili produljene terapijske učinke ili nuspojave.
Each tablet contains 59 micrograms sunset yellow FCF aluminium lake (E110). 
Jedna tableta sadrži 59 mikrograma bojila sunset yellow FCF aluminium lake (E110).
PHOSPHODIESTERASE TYPE-5 (PDE-5) INHIBITORS Sildenafil 
INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5)
An increase of > 3 x ULN in alanine aminotransferase or aspartate aminotransferase was recorded in 12.8% of subjects in the cobicistatboosted group and 9.0% in the ritonavir-boosted group. 
Povećanje alanin aminotransferaze ili aspartat aminotransferaze za > 3 x GGN zabilježeno je u 12,8% ispitanika u skupini koja je primala kobicistatom pojačani lijek, odnosno u 9,0% ispitanika u skupini koja je primala ritonavirom pojačani lijek.
Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg + cobicistat 150 mg once daily or atazanavir 300 mg + ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet. 
Bolesnici su randomizirani u omjeru 1:1 kako bi primali ili atazanavir 300 mg + kobicistat 150 mg jednom dnevno ili atazanavir 300 mg + ritonavir 100 mg jednom dnevno, a svakom je primijenjen fiksni pozadinski režim koji sadrži tenofovirdizoproksilfumarat 300 mg i emtricitabin 200 mg primijenjen kao tableta kombinacije fiksne doze.
The effect of cobicistat on serum creatinine and eGFR in patients switching from ritonavir to cobicistat in Study GS-US-236-0118 was consistent with the effect in treatmentnaïve patients in Study GS-US-216-0114. 
Učinak kobicistata na serumski kreatinin i eGFR u bolesnika koji su se prebacili s ritonavira na kobicistat u ispitivanju GS-US-236-0118 bio je u skladu s učinkom u bolesnika koji prethodno nisu bili liječeni u ispitivanju GS-US-216-0114.
Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine. 
Dokazano je da kobicistat smanjuje procijenjeni klirens kreatinina zbog inhibicije tubularne sekrecije kreatinina.
• difficulty sleeping, abnormal dreams, drowsiness, tiredness (fatigue) 
• otežano spavanje, abnormalni snovi, omamljenost, umor.
How to store Tybost 
Kako čuvati Tybost
Table 7: Virologic outcome of randomised treatment of Study GS-US-216-0114 at weeks 48 and Week 48a 
Tablica 7: Virološki ishod randomiziranog liječenja u ispitivanju GS-US-216-0114 u 48. i 144. tjednu
Treatment with cobicistat and darunavir during pregnancy results in lower darunavir exposure. 
Liječenje kobicistatom i darunavirom tijekom trudnoće rezultirat će manjom izloženošću darunaviru.
• sedatives/hypnotics: orally administered midazolam, triazolam 
• sedativi/hipnotici: midazolam primijenjen peroralno, triazolam.
Co-administration of cobicistat with medicinal products such as dihydroergotamine, ergotamine, ergometrine, orally administered midazolam, triazolam, amiodarone, quinidine, pimozide, lurasidone, alfuzosin, simvastatin, lovastatin, and sildenafil which are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (see section 4.3). 
Kontraindicirana je istodobna primjena kobicistata s lijekovima poput dihidroergotamina, ergotamina, ergometrina, peroralno primijenjenog midazolama, triazolama, amiodarona, kinidina, pimozida, lurasidona, alfuzozina, simvastatina, lovastatina i sildenafila čiji klirens uvelike ovisi o CYP3A i za koje su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima (vidjeti dio 4.3).
Adverse reactions for cobicistat-boosted atazanavir were consistent with the safety profile of ritonavirboosted atazanavir. 
Nuspojave na kobicistatom pojačani atazanavir bile su u skladu sa sigurnosnim profilom ritonavirom pojačanog atazanavira.
Co-administration with dabigatran etexilate, a P-glycoprotein (P-gp) substrate, is contraindicated (see section 4.5). 
Istodobna primjena s dabigatran eteksilatom, supstratom P-glikoproteina (P-gp) je kontraindicirana (vidjeti dio 4.5)
Tybost contains sunset yellow FCF aluminium lake which may cause allergic reactions. 
Tybost sadrži bojilo sunset yellow FCF aluminium lake koje može uzrokovati alergijske reakcije.
When co-administration is necessary, it is recommended to start with a dose of atorvastatin 10 mg and titrate based on clinical response while monitoring for safety (e.g. myopathy). 
Kada je istodobna primjena neophodna, preporučuje se započeti s dozom atorvastatina od 10 mg i tritrirati na temelju kliničkog odgovora, uz istodobno praćenje zbog sigurnosnih razloga (npr. miopatija).
log10 copies/ml 
≥ 50 kopija/ml.
When co-administration is necessary, do not exceed 10 mg rosuvastatin daily and clinical monitoring for safety (e.g. myopathy) is recommended. 
Kada je istodobna primjena neophodna, doza ne bi smjela prelaziti 10 mg rosuvastatina na dan, a zbog sigurnosnih razloga (npr. miopatija) preporučuje se kliničko praćenje.
Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates (such as atazanavir or darunavir) that have limited oral bioavailability and a short half-life due to CYP3A-dependent metabolism. 
Inhibicija metabolizma posredovanog CYP3A kobicistatom pojačava sistemsku izloženost supstratima CYP3A (kao što su atazanavir ili darunavir) koji imaju ograničenu peroralnu bioraspoloživost i kratki poluvijek zbog metabolizma ovisnog o CYP3A.
Antiviral efficacy data from randomised controlled studies is available for cobicistat-boosted atazanavir, but not for cobicistat-boosted darunavir (see sections 5.1 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 5.1 i 5.2).
No dose adjustment of rilpivirine is required when atazanavir/cobicistat or darunavir/cobicistat are used concomitantly with rilpivirine. 
Nije potrebna prilagodba doze rilpivirina kad se atazanavir/kobicistat ili darunavir/kobicistat primjenjuju istodobno s rilpivirinom.
Tybost should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir). 
Tybost se ne smije započeti primjenjivati u bolesnika s klirensom kreatinina manjim od 70 ml/min ako jedan ili više istodobno primijenjenih lijekova zahtijeva prilagodbu doze na osnovi klirensa kreatinina (npr.emtricitabin, lamivudin, tenofovirdizoproksil ili adefovir).
Co-administration of Tybost with sildenafil for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3). 
Istodobna primjena lijeka Tybost i sildenafila za liječenje plućne arterijske hipertenzije je kontraindicirana (vidjeti dio 4.3).
Concomitant use contraindicated 
Kontraindicirana istodobna primjena
A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 ml/min). 
Ispitivanje farmakokinetike kobicistata provedeno je na ispitanicima koji nisu HIV-1 zaraženi, a koji imaju teško oštećenje funkcije bubrega (procijenjeni klirens kreatinina ispod 30 ml/min).
vomiting, diarrhoea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth Hepatobiliary disorders: Very common: 
povraćanje, proljev, dispepsija, bol u abdomenu, distenzija abdomena, flatulencija, suha usta Poremećaji jetre i žuči: Vrlo često:
No teratogenic effects were observed in rats and rabbit developmental toxicity studies. 
U ispitivanjima razvojne toksičnosti u štakora i kunića nisu opaženi teratogeni učinci.
Median baseline CD4+ cell count (range), cells/mm3 
Medijan početnog broja stanica CD4+ (raspon), stanica/mm3
Darunavir 800 mg + ritonavir 100 mg once daily (n = 31) 
Darunavir 800 mg + ritonavir 100 mg jednom dnevno (n = 31)
Plasma concentrations of these medicinal products may be increased when co-administered with cobicistat, resulting in reduced serum cortisol concentrations. 
Mogu biti povećane koncentracije tih lijekova u plazmi kada se primjenjuju istodobno s kobicistatom, što dovodi do smanjenih koncentracija kortizola u serumu.
The pharmacokinetic enhancing effect of cobicistat on darunavir was evaluated in a phase 1 clinical Study GS-US-216-0115 in 31 healthy subjects that were administered darunavir 800 mg in combination with cobicistat 150 mg or ritonavir 100 mg, all once daily, for 10 days. 
Farmakokinetički pojačavajući učinak kobicistata na darunavir procijenjen je u kliničkom ispitivanju faze 1 GS-US-216-0115 u 31 zdravog ispitanika kojima je primijenjen darunavir 800 mg u kombinaciji s kobicistatom 150 mg ili ritonavirom 100 mg, sve jednom dnevno tijekom 10 dana.
Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with cobicistat. 
Kobicistat reverzibilno inhibira MATE1, stoga se koncentracije metformina mogu povećati s istodobnom primjenom kobicistata.
Therefore, the use of Tybost is not recommended in these patients (see sections 4.4 and 5.2). 
Stoga se primjena lijeka Tybost ne preporučuje u tih bolesnika (vidjeti dijelove 4.4 i 5.2).
Adverse reactions to cobicistat-boosted atazanavir during 144 weeks of clinical trial experience from Study GS-US-216-0114 are listed in Table 3, below, by body system organ class and frequency. 
Nuspojave na kobicistatom pojačani atazanavir tijekom 144 tjedna iskustva kliničkih ispitivanja iz ispitivanja GS-US-216-0114 navedene su u Tablici 3, u nastavku, prema klasifikaciji sustava organa i učestalosti.
• apixaban, edoxaban, rivaroxaban and warfarin, medicines used to prevent and treat blood clots 
• apiksaban, edoksaban, rivaroksaban i varfarin, lijekovi koji se primjenjuju za sprječavanje i liječenja krvnih ugrušaka
Co-administration of cobicistat with medicinal products that induce CYP3A is contraindicated or is not recommended (see sections 4.3 and 4.5) because decreased plasma concentrations of cobicistat could result in plasma levels that are insufficient to achieve adequate pharmacoenhancement of atazanavir or darunavir. 
Istodobna primjena kobicistata s lijekovima koji induciraju CYP3A kontraindicirana je ili se ne preporučuje (vidjeti dijelove 4.3 i 4.5) jer smanjene koncentracije kobicistata u plazmi mogu za posljedicu imati razine kobicistata u plazmi koje nisu dostatne za postizanje odgovarajućeg farmakokinetičkog pojačanja atazanavira ili darunavira.
Pack sizes containing 1 bottle of 30 film-coated tablets or 3 bottles of 30 film-coated tablets. 
Veličine pakiranja: 1 bočica s 30 filmom obloženih tableta ili 3 bočice od 30 filmom obloženih tableta.
Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long-term use. 
Potrebno je uzeti u obzir alternativne kortikosteroide koji manje ovise o metabolizmu putem CYP3A, npr. beklometazon za intranazalnu ili inhalacijsku primjenu, osobito za dugoročnu primjenu.
 Tell your doctor if you are taking any of these HIV medicines. 
 Obavijestite svog liječnika ako uzimate bilo koji od ovih lijekova.
Co-administration with Tybost may increase dabigatran plasma concentrations with similar effects as seen with other strong P-gp inhibitors. 
Koncentracije dabigatrana u plazmi mogu se povećati pri istodobnoj primjeni lijeka Tybost, s učinkom sličnim kao kod drugih jakih P-gp inhibitora.
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).