FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: Co-administration of salmeterol with cobicistat may result in increased plasma concentrations of salmeterol.
Croatian: Istodobna primjena salmeterola i kobicistata može za posljedicu imati povećane koncentracije salmeterola u plazmi.
English: 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.
Croatian: 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.
English: K65R or K70E, or any primary resistance substitution associated with protease inhibitors.
Croatian: Nijedan ispitanik nije razvio s tenofovirom povezanu rezistentnu supstituciju K65R, ili K70E, ili bilo koje druge primarne rezistentne supstitucije povezane s inhibitorima proteaze.
English: Tybost contains the active substance cobicistat.
Croatian: Tybost sadrži djelatnu tvar kobicistat.
English: Atazanavir pharmacokinetics parameters
Croatian: Farmakokinetički parametri atazanavira
English: • vomiting, diarrhoea, stomach pain, problems with digestion resulting in pain after meals
Croatian: • povraćanje, proljev, bol u trbuhu, problemi s probavom koji za posljedicu imaju bolove nakon obroka (dispepsija), osjećaj nadutosti, vjetrovi (flatulencija)
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Croatian: Kobicistat se metabolizira putem oksidacije posredovane CYP3A (glavni put) i CYP2D6 (sporedni put) te ne prolazi glukuronidaciju.
English: Tybost 150 mg film-coated tablets
Croatian: Tybost 150 mg filmom obložene tablete kobicistat
English: HMG Co-A REDUCTASE INHIBITORS Fluvastatin
Croatian: INHIBITORI REDUKTAZE HMG-CoA
English: Co-administration of cobicistat with dabigatran is contraindicated.
Croatian: Istodobna primjena kobicistata s dabigatranom je kontraindicirana.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Croatian: Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za kobicistat.
English: Co-administration with cobicistat can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.4).
Croatian: Istodobna primjena s kobicistatom može povećati plazmatske koncentracije lijekova koje metabolizira CYP2D6 (vidjeti dijelove 4.3 i 4.4).
English: Digoxin (0.5 mg single dose)/Cobicistat (150 mg multiple doses)
Croatian: Digoksin (jedna doza od 0,5 mg) / kobicistat (više doza od 150 mg)
English: 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).
Croatian: 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).
English: You must remain under the care of your doctor while taking Tybost.
Croatian: Za vrijeme uzimanja lijeka Tybost morate ostati pod skrbi svog liječnika.
English: Plasma concentrations of HMG Co-A reductase inhibitors may be increased when co-administered with cobicistat.
Croatian: Koncentracije inhibitora reduktaze HMG-CoA u plazmi mogu se povećati kod istodobne primjene s kobicistatom.
English: Changes in CD4+ cell counts through 48 and 144 weeks in Study GS-US-216-0114 are presented in Table 8.
Croatian: Promjene broja CD4+ stanica kroz 48 tjedana odnosno 144 tjedna ispitivanja GS-US-216-0114 prikazane su u tablici 8.
English: See sections 4.2, 4.4, 5.1 and 5.2.
Croatian: Vidjeti dijelove 4.2, 4.4, 5.1 i 5.2. 4.2 Doziranje i način primjene
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for cobicistat.
Croatian: Klinički značajne farmakokinetičke razlike vezane uz etničku pripadnost nisu ustanovljene za kobicistat.
English: Concentrations of ketoconazole and/or cobicistat may increase with co-administration of cobicistat.
Croatian: Koncentracije ketokonazola i/ili kobicistata mogu se povećati s istodobnom primjenom kobicistata.
English: The active substance is cobicistat.
Croatian: Djelatna tvar je kobicistat.
English: Concentrations of voriconazole may increase or decrease when co-administered with cobicistat.
Croatian: Koncentracije vorikonazola mogu se povećati ili smanjiti s istodobnom primjenom kobicistata.
English: Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.
Croatian: Koncentracije itrakonazola, flukonazola i pozakonazola mogu se povećati s istodobnom primjenom kobicistata.
English: You should not take Tybost with other medicines containing:
Croatian: Lijekovi koji se primjenjuju za liječenje infekcije HIV-om: Ne smijete uzimati Tybost s drugim lijekovima koji sadrže:
English: Buprenorphine/Naloxone
Croatian: Buprenorfin/nalokson
English: 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).
Croatian: 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).
English: No dose adjustment of cobicistat is required.
Croatian: Nije potrebna prilagodba doze kobicistata.
English: • nevirapine
Croatian: • nevirapin
English: 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.
Croatian: 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
English: For additional drug-drug interactions with atazanavir or darunavir, consult their respective Summary of Product Characteristics when using Tybost.
Croatian: Za dodatne interakcije između lijekova s atazanavirom ili darunavirom potrebno je proučiti njihov sažetak opisa svojstava lijeka kad se primjenjuju istodobno s lijekom Tybost.
English: Co-administration with cobicistat can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.5).
Croatian: Istodobna primjena s kobicistatom može povećati koncentracije lijekova u plazmi koje metabolizira CYP2D6 (vidjeti dijelove 4.3 i 4.5).
English: Co-administration of cobicistat with carbamazepine is contraindicated (see section 4.3).
Croatian: Istodobna primjena kobicistata i karbamazepina je kontraindicirana (vidjeti dio 4.3).
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Tybost.
Croatian: U bolesnika koji uzimaju Tybost preporučuju se pažljivi nadzor bolesnika i prilagodba doze metformina.
English: Concentrations of calcium channel blockers may be increased when co-administered with cobicistat.
Croatian: Koncentracije blokatora kalcijevih kanala mogu se povećati kod istodobne primjene s kobicistatom.
English: Nevirapine
Croatian: Nevirapin
English: Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Kobicistat nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
English: No dose adjustment of cobicistat is necessary for patients with mild to moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze kobicistata za bolesnike s blagim do umjerenim oštećenjem funkcije jetre.
English: 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).
Croatian: 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).
English: No clinically relevant differences in cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Croatian: Nisu zapažene klinički značajne razlike u farmakokinetici kobicistata između ispitanika s umjerenim oštećenjem funkcije jetre i zdravih ispitanika.
English: 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.
Croatian: U kliničkim ispitivanjima, kobicistat je istodobno primjenjivan s atazanavirom ili darunavirom na puni želudac u skladu sa sažetkom opisa svojstava za te lijekove.
English: Co-administration of neuroleptics with cobicistat may result in increased plasma concentrations of neuroleptics.
Croatian: Istodobna primjena neuroleptika s kobicistatom može za posljedicu imati povećane koncentracije neuroleptika u plazmi.
English: insomnia, abnormal dreams
Croatian: nesanica, poremećeni snovi
English: For more information on the side effects of atazanavir or darunavir see the package leaflets for these medicines.
Croatian: Za više informacija o nuspojavama atazanavira ili darunavira proučite uputu o lijeku za te lijekove.
English: When clarithromycin is co-administered with darunavir/cobicistat, consult the darunavir Summary of Product Characteristics for dosing recommendations.
Croatian: Kad se klaritromicin primjenjuje istodobno s darunavirom/kobicistatom proučiti sažetak opisa svojstava darunavira za preporuke o doziranju.
English: The steady-state pharmacokinetic parameters of darunavir were comparable when boosted with cobicistat versus ritonavir (see Table 5).
Croatian: Farmakokinetički parametri u stanju dinamičke ravnoteže darunavira pojačanog kobicistatom bili su usporedivi s ritonavirom (vidjeti Tablicu 5).
English: 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.
Croatian: 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.
English: 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
Croatian: 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
English: 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
Croatian: AUCtau (µg•h/ml) Cmax (µg/ml) Ctau (µg/ml) a Plus pozadinski režim kombinacije fiksne doze emtricitabina 200 mg i tenofovirdizoproksilfumarata 300 mg
English: 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.
Croatian: 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.
English: Alternative antibiotics should be considered for co-administration with atazanavir/cobicistat.
Croatian: Potrebno je razmotriti istodobnu primjenu drugih antibiotika s atazanavirom/kobicistatom.
English: Co-administration of rilpivirine and cobicistat is expected to increase the plasma concentration of rilpivirine.
Croatian: Očekuje se da će istodobna primjena rilpivirina i kobicistata povećati koncentraciju rilpivirina u plazmi.
English: Itraconazole Voriconazole Posaconazole Fluconazole
Croatian: Itrakonazol Vorikonazol Pozakonazol Flukonazol
English: Carbamazepine-10,11-epoxide:
Croatian: Karbamazepin-10,11-epoksid: AUC: ↓ 35%
English: Etravirine
Croatian: Etravirin
English: Dosing recommendations for such combinations have not been established and may result in decreased plasma concentrations of atazanavir, darunavir and/or the other antiretroviral agents that require pharmacoenhancement leading to loss of antiviral activity and development of resistance.
Croatian: Preporuke za doziranje takvih kombinacija nisu utvrđene i istodobna primjena može za posljedicu imati smanjene plazmatske koncentracije atazanavira, darunavira i/ili drugih antiretrovirusnih lijekova koji zahtijevaju farmakokinetičko pojačanje što dovodi do gubitka antivirusne aktivnosti i razvoja rezistencije.
English: • buspirone, clorazepate, diazepam, estazolam, flurazepam, perphenazine, risperidone,
Croatian: • buspiron, klorazepat, diazepam, estazolam, flurazepam, perfenazin, risperidon, tioridazin, zolpidem, lijekovi koji se primjenjuju za liječenje poremećaja živčanog sustava
English: Contains sunset yellow FCF aluminium lake (E110), see leaflet for further information.
Croatian: POPIS POMOĆNIH TVARI Sadrži bojilo sunset yellow FCF aluminium lake (E110), za dodatne informacije vidjeti uputu o lijeku.
English: Plasma concentrations of, pitavastatin, fluvastatin or pravastatin are expected to increase when co-administered with atazanavir/cobicistat or darunavir/cobicistat.
Croatian: Očekuje se da će se koncentracije pitavastatina, fluvastatina ili pravastatina u plazmi povećati kod istodobne primjene atazanavira/kobicistata ili darunavira/kobicistata.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Croatian: Kobicistat je selektivni inhibitor temeljen na mehanizmu citokroma P450 podobitelji CYP3A.
English: AUC: ↑ 525% Cmax: ↑ 384% Cmin: ↑ 394%
Croatian: 25-O-dezacetilrifabutin: AUC: ↑ 525% Cmax: ↑ 384% Cmin: ↑ 394%
English: Other types of medicine: • ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole, medicines used to treat fungal infections
Croatian: • ketokonazol, itrakonazol, vorikonazol, pozakonazol i flukonazol, lijekovi koji se primjenjuju za liječenje gljivičnih infekcija
English: Data are not available to make recommendations on the use of darunavir/cobicistat or atazanavir/cobicistat with other oral contraceptives than drospirenone/ethinyloestradiol.
Croatian: Nema dostupnih podataka pa nije moguće dati preporuke za primjenu darunavira/kobicistata ili atazanavira/kobicistata s drugim oralnim kontraceptivima osim drospirenona/etinilestradiola.
English: Clinical monitoring is recommended and a dose reduction may be necessary when these beta-blockers are co-administered with Tybost.
Croatian: U slučaju istodobne primjene lijeka Tybost i ovih beta-blokatora preporučuje se klinički nadzor i može biti potrebno smanjenje doze.
English: Each film-coated tablet contains 150 mg cobicistat.
Croatian: Jedna filmom obložena tableta sadrži 150 mg kobicistata.
English: Co-administration of Tybost with medicinal products that are substrates of these transporters can result in increased plasma concentrations of the co-administered medicinal products (see section 4.4).
Croatian: Istodobna primjena lijeka Tybost sa lijekovima koji su supstrati tih transportera može za posljedicu imati povećane koncentracije istodobno primijenjenih lijekova u plazmi (vidjeti dio 4.4).
English: Atazanavir + cobicistata (n = 22)
Croatian: Atazanavir + kobicistata (n = 22)
English: Darunavir 800 mg + cobicistat 150 mg once daily (n = 31)
Croatian: Darunavir 800 mg + kobicistat 150 mg jednom dnevno (n = 31)
English: Concentrations of beta-blockers may be increased when co-administered with cobicistat.
Croatian: Koncentracije beta-blokatora mogu se povećati kod istodobne primjene s kobicistatom.
English: Musculoskeletal and connective tissue disorders: Uncommon:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva: Manje često:
English: Co-administration of tenofovir disoproxil with cobicistat is expected to increase tenofovir plasma concentration.
Croatian: Očekuje se da će istodobna primjena tenofovirdizoproksila i kobicistata povećati koncentraciju tenofovira u plazmi.
English: Atazanavir + cobicistata (n = 344)
Croatian: Atazanavir + kobicistata (n = 344)
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Croatian: Interakcije između kobicistata i potencijalno istodobno primijenjenih lijekova navedene su u sljedećoj Tablici 2 (povećanje je označeno kao „↑“, smanjenje kao „↓“, bez promjene kao „↔“).
English: The steady-state pharmacokinetic parameters of atazanavir were comparable when boosted with cobicistat versus ritonavir (see Table 4).
Croatian: Farmakokinetički parametri u stanju dinamičke ravnoteže atazanavira pojačanog kobicistatom bili su usporedivi s ritonavirom (vidjeti Tablicu 4).
English: Consult atazanavir Summary of Product Characteristics for dosing recommendations.
Croatian: Potrebno je proučiti sažetak opisa svojstava lijeka za atazanavir za preporuke o doziranju.
English: Co-administration of rifabutin, a potent CYP3A inducer, may significantly decrease cobicistat plasma concentrations.
Croatian: Istodobna primjena rifabutina, potentnog induktora enzima CYP3A, može značajno smanjiti koncentracije kobicistata u plazmi.
English: Co-administration of cobicistat with medicinal products that inhibit CYP3A may result in increased plasma concentration of cobicistat.
Croatian: Istodobna primjena kobicistata s lijekovima koji inhibiraju CYP3A može za posljedicu imati povećanu koncentraciju kobicistata u plazmi.
English: • colchicine, a medicine used to treat gout  Tell your doctor if you are taking any of these medicines.
Croatian: • maravirok  Obavijestite svog liječnika ako uzimate ijedan od ovih lijekova za HIV.
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate.
Croatian: Kobicistat je jaki inhibitor CYP3A temeljen na mehanizmu i supstrat CYP3A.
English: pyrexia, asthenia
Croatian: pireksija, astenija
English: Co-administration of carbamazepine, a potent CYP3A inducer, may significantly decrease cobicistat plasma concentrations.
Croatian: Istodobna primjena karbamazepina, potentnog induktora enzima CYP3A, može značajno smanjiti koncentracije kobicistata u plazmi.
English: AUC: ↑ 43% Cmax: ↑ 40% Cmin: ↑ 51%
Croatian: Karbamazepin: AUC: ↑ 43% Cmax: ↑ 40% Cmin: ↑ 51%
English: AUC: ↔ Cmax: ↔ Cmin: ↔
Croatian: Kobicistat: AUC: ↔ Cmax: ↔ Cmin: ↔
English: AUC: ↔ Cmax: ↑ 41% Cmin: ND
Croatian: AUC: ↔ Cmax: ↑ 41% Cmin: NO
English: Concentrations of these antiarrhythmic medicinal products may be increased when co-administered with cobicistat.
Croatian: Koncentracije tih antiaritmičkih lijekova mogu se povećati s istodobnom primjenom kobicistata.
English: Data are not available to make recommendations on the use of atazanavir/cobicistat or darunavir/cobicistat with other oral contraceptives.
Croatian: Nema dostupnih podataka pa nije moguće dati preporuke za primjenu atazanavira/kobicistata ili darunavira/kobicistata s drugim oralnim kontraceptivima.
English: Antimycobacterials Rifabutin (150 mg every other day)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Croatian: Antimikobakterijski lijekovi Rifabutin (150 mg svaki drugi dan)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
English: Co-administration of cobicistat in patients receiving medicinal products that are substrates of these transporters may result in increased plasma concentrations of the co-administered medicinal products (see section 4.5).
Croatian: Istodobna primjena kobicistata u bolesnika koji primaju lijekove koji su supstrati tih transportera može za posljedicu imati povećane koncentracije istodobno primijenjenih lijekova u plazmi (vidjeti dio 4.5).
English: • amlodipine, digoxin, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol,
Croatian: • amlodipin, digoksin, diltiazem, dizopiramid, felodipin, flekainid, lidokain, metoprolol, meksiletin, nikardipin, nifedipin, propafenon, timolol i verapamil, lijekovi koji se primjenjuju za liječenje srčanih problema
English: AUC: ↑ 822% Cmax: ↑ 1785%
Croatian: Atorvastatin: AUC: ↑ 822% Cmax: ↑ 1785% Cmin: NI
English: AUC: ↔ Cmax: ↓ 13% Cmin: ND
Croatian: AUC: ↔ Cmax: ↓ 13% Cmin: NO
English: Concentrations of these immunosuppressants may be increased when co-administered with cobicistat.
Croatian: Koncentracije ovih imunosupresiva mogu se povećati kod istodobne primjene s kobicistatom.
English: Methadone:
Croatian: Metadon
English: Co-administration of cobicistat with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of cobicistat and consequently that of atazanavir or darunavir being boosted, leading to loss of therapeutic effect and possible development of resistance.
Croatian: Istodobna primjena kobicistata s lijekovima koji su umjereni do slabi induktori CYP3A može za posljedicu imati smanjenu koncentraciju kobicistata u plazmi i posljedično smanjenje pojačanja atazanavira ili darunavira što uzrokuje gubitak terapijskog učinka i mogući razvoj rezistencije.
English: Therapy with cobicistat and darunavir should not be initiated during pregnancy, and women who become pregnant during therapy with cobicistat and darunavir should be switched to an alternative regimen (see sections 4.2 and 4.4).
Croatian: Terapija kobicistatom i darunavirom ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije kobicistatom i darunavirom treba prebaciti na drugi režim (vidjeti dijelove 4.2 i 4.4).