FrancophonIA/ELRC3.0 huggingface dataset:
English: If the patient has developed SJS or DRESS associated with the use of EVOTAZ, EVOTAZ may not be restarted.
Slovenian: Če se pri bolniku zaradi zdravljenja z zdravilom EVOTAZ pojavita Stevens-Johnsonov sindrom ali sindrom DRESS, se zdravljenja z zdravilom EVOTAZ morda ne bo smelo ponovno uvesti.
English: No virologic data in week 48 or week 144 window Discontinued study drug due to AE or deathd
Slovenian: Brez viroloških podatkov v okviru 48. tedna ali 144. tedna
English: Pharmacotherapeutic group: Antivirals for systemic use; antivirals for treatment of HIV infections, combinations.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, protivirusna zdravila za zdravljenje okužb z virusom HIV, kombinacije, oznaka ATC: J05AR15
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors.
Slovenian: Študije sicer niso bile izvedene, vendar pa se pri sočasni uporabi zaviralcev proteaz izpostavljenost pravastatinu ali fluvastatinu lahko poveča.
English: What EVOTAZ contains
Slovenian: Kaj vsebuje zdravilo EVOTAZ
English: A safe and effective dose in combination with EVOTAZ has not been established for sildenafil when used to treat pulmonary arterial hypertension.
Slovenian: Varnega in učinkovitega odmerka sildenafila za zdravljenje pljučne arterijske hipertenzije, ki bi ga lahko uporabljali skupaj z zdravilom EVOTAZ, niso ugotovili.
English: Co-administration of EVOTAZ with other protease inhibitors is not recommended.
Slovenian: Sočasna uporaba zdravila EVOTAZ in drugih zaviralcev proteaz ni priporočljiva.
English: Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving atazanavir (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z atazanavirjem, se je pojavilo reverzibilno zvišanje indirektnega (nekonjugiranega) bilirubina, kar je povezano z zaviranjem UDP-glukuronoziltransferaze (UGT) (glejte poglavje 4.8).
English: These medicinal products include alfuzosin, amiodarone, astemizole, bepridil, cisapride, colchicine, dronedarone, ergot deriviatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine), lovastatin, orally administered midazolam, pimozide, quetiapine, quinidine, lurasidone, simvastatin, sildenafil (when used to treat pulmonary arterial hypertension), avanafil, systemic lidocaine, ticagrelor, terfenadine and triazolam.
Slovenian: Takšna zdravila so alfuzosin, amiodaron, astemizol, bepridil, cisaprid, kolhicin, dronedaron, derivati ergot alkaloidov (npr. dihidroergotamin, ergometrin, ergotamin in metilergonovin), lovastatin, peroralno uporabljen midazolam, pimozid, kvetiapin, kinidin, lurasidon, simvastatin, sildenafil (če se uporablja za zdravljenje pljučne arterijske hipertenzije), avanafil, lidokain za sistemsko uporabo, ticagrelor, terfenadin in triazolam.
English: Metabolism and nutrition disorders common increased appetite uncommon weight decreased, weight gain, anorexia
Slovenian: Presnovne in prehranske motnje pogosti povečanje apetita občasni zmanjšanje telesne mase, povečanje telesne mase, anoreksija
English: Among experienced patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
Slovenian: Pri predhodno že zdravljenih bolnikih, ki so atazanavir v odmerku 300 mg enkrat na dan skupaj z ritonavirjem v odmerku 100 mg enkrat na dan prejemali v povprečju 95 tednov, se je zvišanje vrednosti celokupnega bilirubina stopnje 3 ali 4 pojavilo pri 53 % bolnikov.
English: Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5 inhibitor-associated adverse events.
Slovenian: Pri sočasni uporabi zdravila EVOTAZ se koncentracije zaviralca PDE5 lahko povečajo in s tem se poveča tudi pojavnost neželenih učinkov zaviralca PDE5.
English: Dolutegravir is not expected to affect the pharmacokinetics of EVOTAZ.
Slovenian: Vpliva dolutegravirja na farmakokinetiko zdravila EVOTAZ ni pričakovati.
English: NAME OF THE MEDICINAL PRODUCT EVOTAZ 300 mg/150 mg film-coated tablets atazanavir/cobicistat
Slovenian: EVOTAZ 300 mg/150 mg filmsko obložene tablete atazanavir/kobicistat
English: Avoid concomitant use of EVOTAZ and rivaroxaban.
Slovenian: Sočasni uporabi zdravila EVOTAZ in rivaroksabana se je treba izogibati.
English: Co-administration with EVOTAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events.
Slovenian: Pri sočasni uporabi zdravila EVOTAZ se koncentracije salmeterola lahko povečajo in s tem se poveča tudi pojavnost neželenih učinkov salmeterola.
English: Unchanged drug accounted for approximately 20% and 7% of the administered dose in the faeces and urine, respectively.
Slovenian: Z blatom se je v obliki nespremenjenega zdravila izločilo približno 20 % uporabljenega odmerka, z urinom pa približno 7 %.
English: Atazanavir 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.
Slovenian: Zaradi zmanjšanja koncentracij kobicistata v plazmi se lahko zmanjšajo tudi koncentracije atazanavirja v plazmi, kar lahko povzroči izgubo terapevtskega učinka in razvoj odpornosti.
English: Co-administration of tenofovir alafenamide with cobicistat is expected to increase tenofovir alafenamide and tenofovir plasma concentrations.
Slovenian: Pri sočasni uporabi alafenamidtenofovirata in kobicistata je pričakovati povečanje koncentracij alafenamidtenofovirata in tenofovirja v plazmi.
English: Clinically significant interactions between EVOTAZ and substrates of CYP1A2, CYP2B6, CYP2C9 or CYP2C19 are not expected.
Slovenian: Klinično pomembnih interakcij med zdravilom EVOTAZ in substrati za CYP1A2, CYP2B6, CYP2C9 ali CYP2C19 ne pričakujemo.
English: cobicistat, a booster (pharmacokinetic enhancer) to help improve the effects of atazanavir.
Slovenian: kobicistat (stopnjevalec farmakokinetike), ki okrepi učinke atazanavirja in tako izboljša njegovo delovanje.
English: Famotidine 20 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily) in HIV-infected patients
Slovenian: Famotidin 20 mg dvakrat na dan (atazanavir 300 mg/ritonavir 100 mg enkrat na dan) pri bolnikih, okuženih z virusom HIV
English: Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indeces and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Slovenian: Kontraindicirana je sočasna uporaba zdravila EVOTAZ in zdravil, ki so substrati za CYP3A, imajo ozek terapevtski indeks in katerih povečane koncentracije v plazmi so povezane z resnimi in/ali smrtno nevarnimi neželenimi učinki.
English: Atazanavir, an active component of EVOTAZ, has been detected in human milk.
Slovenian: Atazanavir, učinkovino zdravila EVOTAZ, so zaznali v materinem mleku.
English: Film-coating hypromellose (hydroxypropyl methyl cellulose, E464) titanium dioxide (E171) talc (E553b) triacetin (E1518) red iron oxide (E172)
Slovenian: Filmska obloga hipromeloza (hidroksipropilmetil celuloza, E464) titanov dioksid (E171) smukec (E553b) triacetin (E1518) rdeči železov oksid (E172)
English: available for co-administration of EVOTAZ with either ketoconazole or itraconazole.
Slovenian: Pri sočasni uporabi zdravila EVOTAZ in ketokonazola ali itrakonazola
English: Cobicistat is a weak CYP2D6 inhibitor and is metabolised to a minor extent by CYP2D6.
Slovenian: Kobicistat je šibek zaviralec CYP2D6 in se v manjšem obsegu presnavlja s CYP2D6.
English: The resistance profile of EVOTAZ is driven by atazanavir.
Slovenian: Profil odpornosti proti zdravilu EVOTAZ je posledica odpornosti proti atazanavirju.
English: Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-associated adverse events, including hypotension, visual changes, and priapism.
Slovenian: Pri sočasni uporabi zdravila EVOTAZ se lahko koncentracije zaviralca PDE5 povečajo in pojavijo njegovi neželeni učinki, kot so hipotenzija, spremembe vida in priapizem.
English: Simeprevir may increase atazanavir and/or cobicistat plasma concentrations.
Slovenian: Simeprevir lahko poveča koncentracije atazanavirja in/ali kobicistata v plazmi.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Slovenian: Pri z virusom HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe.
English: EVOTAZ 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; see sections 4.2, 4.8 and 5.2).
Slovenian: Zdravljenja z zdravilom EVOTAZ se ne sme uvesti pri bolnikih s kreatininskim očistkom, manjšim od 70 ml/min, če je treba odmerek enega ali več sočasno uporabljenih zdravil (npr. emtricitabin, lamivudin, dizoproksiltenofovirat ali adefovir) prilagoditi na osnovi vrednosti kreatininskega očistka (glejte poglavja 4.2, 4.8 in 5.2).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Among naïve patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 96 weeks, 48% had Grade 3-4 total bilirubin elevations (see section 4.4).
Slovenian: Pri predhodno še nezdravljenih bolnikih, ki so atazanavir v odmerku 300 mg enkrat na dan skupaj z ritonavirjem v odmerku 100 mg enkrat na dan prejemali v povprečju 96 tednov, se je zvišanje vrednosti celokupnega bilirubina stopnje 3 ali 4 pojavilo pri 48 % bolnikov (glejte poglavje 4.4).
English: Co-administration of simvastatin or lovastatin with EVOTAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Slovenian: Sočasna uporaba simvastatina ali lovastatina in zdravila EVOTAZ je kontraindicirana zaradi večjega tveganja za pojav miopatije, vključno z rabdomiolizo (glejte poglavje 4.3).
English: EVOTAZ should be used with caution in patients with mild hepatic impairment (see sections 4.2, 4.3 and 5.2).
Slovenian: Pri bolnikih z blago okvaro jeter je treba zdravilo EVOTAZ uporabljati previdno (glejte poglavja 4.2, 4.3 in 5.2).
English: Co-administration with EVOTAZ may cause a large increase in the concentration of these benzodiazepines.
Slovenian: Pri sočasni uporabi zdravila EVOTAZ se lahko koncentracije teh benzodiazepinov močno povečajo.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: EVOTAZ is not recommended for co-administration with etravirine because it may result in the loss of therapeutic effect and development of resistance to atazanavir.
Slovenian: Zdravila EVOTAZ ni priporočljivo uporabljati skupaj z etravirinom, ker lahko pri takšni uporabi pride do izgube terapevtskega učinka in razvoja odpornosti proti atazanavirju.
English: The mechanism of interaction between efavirenz and atazanavir, or efavirenz and cobicistat is CYP3A4 induction by efavirenz.
Slovenian: Mehanizem interakcije med efavirenzem in atazanavirjem ali efavirenzem in kobicistatom je indukcija CYP3A4 z efavirenzem.
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended (see section 4.3).
Slovenian: Priporočamo uporabo drugih zaviralcev agregacije trombocitov, na katere zaviranje ali indukcija CYP ne vpliva (npr. prasugrel) (glejte poglavje 4.3).
English: Eye disorders very common ocular icterus
Slovenian: Očesne bolezni zelo pogosti očesni ikterus
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking EVOTAZ.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom EVOTAZ, priporočamo skrben nadzor in prilagoditev odmerka metformina.
English: Mean urinary excretion of unchanged drug was 7% following 2 weeks of dosing at 800 mg once daily.
Slovenian: Pri 2-tedenski uporabi v odmerku 800 mg enkrat na dan je povprečno izločanje nespremenjenega zdravila z urinom znašalo 7 %.
English: Each film-coated tablet contains 300 mg of atazanavir (as sulphate), and 150 mg cobicistat.
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg atazanavirja (v obliki sulfata) in 150 mg kobicistata.
English: Tablet core microcrystalline cellulose (E460(i)) croscarmellose sodium (E468) sodium starch glycolate crospovidone (E1202) stearic acid (E570) magnesium stearate (E470b) hydroxypropyl cellulose (E463) silicon dioxide (E551)
Slovenian: Jedro tablete mikrokristalna celuloza (E460(i)) premreženi natrijev karmelozat (E468) natrijev karboksimetilškrob krospovidon (E1202) stearinska kislina (E570) magnezijev stearat (E470b) hidroksipropilceluloza (E463) silicijev dioksid (E551)
English: Co-administration of voriconazole and EVOTAZ is not recommended unless an assessment of the benefit/risk justifies the use of voriconazole (see section 4.5).
Slovenian: Sočasna uporaba vorikonazola in zdravila EVOTAZ ni priporočljiva, razen če ocena koristi/tveganj opraviči uporabo vorikonazola (glejte poglavje 4.5).
English: As EVOTAZ contains atazanavir and cobicistat, the adverse reactions associated with each of the individual components may be expected.
Slovenian: Zdravilo EVOTAZ vsebuje atazanavir in kobicistat, zato lahko pričakujemo pojav neželenih učinkov, povezanih z vsako posamezno sestavino zdravila.
English: The combination of pimozide, quetiapine or lurasidone and EVOTAZ is contraindicated (see section 4.3).
Slovenian: Uporaba pimozida,kvetiapina ali lurasidona v kombinaciji z zdravilom EVOTAZ je kontraindicirana (glejte poglavje 4.3).
English: A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Slovenian: Farmakokinetično študijo s kobicistatom so izvedli pri osebah z zmerno okvaro jeter (Child-Pugh B) brez okužbe z virusom HIV-1.
English: If EVOTAZ is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of EVOTAZ with food as soon as possible.
Slovenian: Če je bolnik pozabil vzeti predpisani odmerek zdravila EVOTAZ ob običajnem času in od tega še ni minilo več kot 12 ur, mora pozabljeni odmerek zdravila EVOTAZ vzeti skupaj s hrano takoj, ko je to mogoče.
English: No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
Slovenian: Farmakokinetika kobicistata se pri bolnikih s hudo okvaro ledvic ni pomembneje razlikovala od farmakokinetike pri zdravih osebah, kar se sklada z majhnim ledvičnim očistkom kobicistata.
English: The increased incidence of benign hepatic adenomas in female mice was likely secondary to cytotoxic liver changes manifested by single-cell necrosis and is considered to have no relevance for humans at intended therapeutic exposures.
Slovenian: Večja pojavnost benignih jetrnih adenomov pri mišjih samicah je verjetno posledica citotoksičnih jetrnih sprememb, ki se kažejo z nekrozami posameznih jetrnih celic.
English: Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.4)
Slovenian: Pri bolnikih je treba ves čas zdravljenja redno nadzirati delovanje ledvic (glejte poglavje 4.4).
English: Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Slovenian: Pri sočasni uporabi z zdravilom EVOTAZ pričakujemo povečanje plazemskih koncentracij zdravil, ki se presnavljajo s CYP3A, CYP2C8, CYP2D6 in/ali UGT1A1.
English: If you miss a dose of EVOTAZ by 12 hours or less, take it right away with food and then take your next scheduled dose at the usual time.
Slovenian: Če ste pozabili vzeti odmerek zdravila EVOTAZ in od tega še ni minilo več kot 12 ur, pozabljeni odmerek vzemite takoj skupaj s hrano, nato pa nadaljujte z jemanjem zdravila ob običajnem času.
English: Limited data are available on the development of resistance to atazanavir boosted with cobicistat.
Slovenian: Podatki o razvoju odpornosti pri uporabi atazanavirja, okrepljenega s kobicistatom, so omejeni.
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and a weak CYP2D6 inhibitor.
Slovenian: Kobicistat je močan zaviralec mehanizma CYP3A in šibek zaviralec CYP2D6.
English: Cobicistat is a CYP3A substrate and is metabolised to a minor extent by CYP2D6.
Slovenian: Kobicistat je substrat za CYP3A in se v manjšem obsegu presnavlja s CYP2D6.
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate.
Slovenian: Kobicistat je močan zaviralec mehanizma CYP3A in tudi substrat za CYP3A.
English: Plasma levels of cobicistat and consequently of atazanavir may decrease significantly during pregnancy.
Slovenian: Med nosečnostjo se lahko pomembno zmanjšajo plazemske koncentracije kobicistata in posledično tudi atazanavirja.
English: The mechanism of interaction is inhibition of metabolism by atazanavir.
Slovenian: Mehanizem interakcije je zaviranje presnove z atazanavirjem.
English: The safety and efficacy of atazanavir with cobicistat 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).
Slovenian: Varnost in učinkovitost atazanavirja s kobicistatom pri z virusom HIV-1 okuženih bolnikih so vrednotili v randomizirani, dvojno slepi, z učinkovino nadzorovani študiji 3. faze GS-US-216-0114.
English: One EVOTAZ tablet is bioequivalent to one atazanavir capsule (300 mg) plus one cobicistat tablet (150 mg) following single oral dose administration with a light meal in healthy subjects (n=62).
Slovenian: Ena tableta zdravila EVOTAZ je po enkratnem peroralnem odmerku skupaj z lahkim obrokom pri zdravih osebah (n=62) biološko enakovredna eni kapsuli atazanavirja (300 mg) in eni tableti kobicistata (150 mg).
English: Atazanavir with cobicistat
Slovenian: Atazanavir s kobicistatom
English: Co-administration of tenofovir DF with cobicistat is expected to increase tenofovir plasma concentrations.
Slovenian: Pri sočasni uporabi tenofovirja DF in kobicistata pričakujemo povečanje koncentracij tenofovirja v plazmi.
English: Sofosbuvir 400 mg/velpatasvir, 100 mg/voxilaprevir 100 mg single dose* (atazanavir 300 mg with ritonavir 100 mg once daily)
Slovenian: Sofosbuvir 400 mg/velpatasvir, 100 mg/voksilaprevir 100 mg enkratni odmerek* (atazanavir 300 mg z ritonavirjem 100 mg enkrat na dan)
English: The mechanism of interaction is inhibition of CYP2D6 by cobicistat.
Slovenian: Mehanizem interakcije je zaviranje CYP2D6 s kobicistatom.
English: Raltegravir 400 mg twice daily (atazanavir 400 mg)
Slovenian: Raltegravir 400 mg dvakrat na dan (atazanavir 400 mg)
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Slovenian: Nekateri od številnih dejavnikov tveganja za pojav te bolezni so med drugimi lahko tudi trajanje kombiniranega protiretrovirusnega zdravljenja, uporaba kortikosteroidov, uživanje alkohola, hudo zmanjšanje imunskega odziva in višji indeks telesne mase.
English: Common (may affect up to 1 in 10 people) increased appetite, dysgeusia (impairment of the sense of taste), dry mouth headache, dizziness insomnia (difficulty sleeping), abnormal dreams, somnolence (sleepiness) vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), dyspepsia (indigestion), bloated or distended tummy (abdomen), flatulence (wind) hyperbilirubinaemia (increased levels of bilirubin in the blood) rash fatigue (extreme tiredness)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) povečanje apetita, paragevzija (okvara čuta za okušanje), suha usta glavobol, omotica insomnija (nespečnost), neobičajne sanje, somnolenca (bolezenska zaspanost) bruhanje, driska, bolečina v trebuhu (bolečina ali neugodje v želodcu), dispepsija (prebavne motnje), napihnjenost ali napetost trebuha, flatulenca (vetrovi) hiperbilirubinemija (zvišanje vrednosti bilirubina v krvi) izpuščaj izčrpanost (izjemna utrujenost)
English: Increase monitoring for adverse reactions.
Slovenian: Potrebno je pogostejše nadziranje neželenih učinkov.
English: Nervous system disorders common headache, dizziness, somnolence, dysgeusia uncommon peripheral neuropathy, syncope, amnesia
Slovenian: Bolezni živčevja pogosti glavobol, omotica, somnolenca, paragevzija občasni periferna nevropatija, sinkopa, anmnezija
English: No human data on the effect of cobicistat on fertility are available.
Slovenian: Podatkov o vplivu kobicistata na plodnost pri človeku ni.
English: This way, you can be sure your medicine is fully effective and you reduce the risk of the HIV-virus developing resistance to the treatment.
Slovenian: Če boste zdravilo jemali natančno po zdravnikovih navodilih, bo dosežena polna učinkovitost zdravila, tveganje za razvoj odpornosti virusa HIV pa se bo zmanjšalo.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Slovenian: Kobicistat je selektivni zaviralec encimskega mehanizma poddružine CYP3A citokroma P450.
English: Cobicistat, a component of EVOTAZ, has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Slovenian: Za kobicistat, sestavino zdravila EVOTAZ, se je izkazalo, da zmanjša ocenjeni kreatininski očistek, kar je posledica zaviranja tubulne sekrecije kreatinina.
English: No data are available on the pharmacokinetics of atazanavir and cobicistat in combination in paediatric patients.
Slovenian: Podatki o farmakokinetiki atazanavirja in kobicistata v kombinaciji pri pediatričnih bolnikih niso na voljo.
English: Didanosine (enteric coated capsules) 400 mg single dose (atazanavir 400 mg once daily)
Slovenian: Didanozin (gastrorezistentne kapsule) 400 mg enkratni odmerek (atazanavir 400 mg enkrat na dan)
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Slovenian: Kobicistat za razliko od ritonavirja ni induktor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali UGT1A1.
English: In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic single-cell necrosis.
Slovenian: Na splošno so obsegale minimalno do blago zvišanje vrednosti serumskega bilirubina in jetrnih encimov, vakuolizacijo in hipertrofijo jetrnih celic ter, le pri mišjih samicah, nekrozo posameznih jetrnih celic.
English: NAME OF THE MEDICINAL PRODUCT EVOTAZ 300 mg/150 mg film-coated tablets
Slovenian: EVOTAZ 300 mg/150 mg filmsko obložene tablete 2.
English: Hepatobiliary disorders very common jaundice common hyperbilirubinaemia uncommon hepatitis, cholelithiasisa, cholestasisa rare hepatosplenomegaly, cholecystitisa
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo pogosti zlatenica pogosti hiperbilirubinemija občasni hepatitis, holelitiazaa, holestazaa redki hepatosplenomegalija, holecistitsa