natgillin/translations-raw huggingface dataset:
As EVOTAZ contains atazanavir and cobicistat, the adverse reactions associated with each of the individual components may be expected.
Zdravilo EVOTAZ vsebuje atazanavir in kobicistat, zato lahko pričakujemo pojav neželenih učinkov, povezanih z vsako posamezno sestavino zdravila.
The combination of pimozide, quetiapine or lurasidone and EVOTAZ is contraindicated (see section 4.3).
Uporaba pimozida,kvetiapina ali lurasidona v kombinaciji z zdravilom EVOTAZ je kontraindicirana (glejte poglavje 4.3).
A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Farmakokinetično študijo s kobicistatom so izvedli pri osebah z zmerno okvaro jeter (Child-Pugh B) brez okužbe z virusom HIV-1.
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.
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.
No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
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.
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.
Večja pojavnost benignih jetrnih adenomov pri mišjih samicah je verjetno posledica citotoksičnih jetrnih sprememb, ki se kažejo z nekrozami posameznih jetrnih celic.
Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.4)
Pri bolnikih je treba ves čas zdravljenja redno nadzirati delovanje ledvic (glejte poglavje 4.4).
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Pri sočasni uporabi z zdravilom EVOTAZ pričakujemo povečanje plazemskih koncentracij zdravil, ki se presnavljajo s CYP3A, CYP2C8, CYP2D6 in/ali UGT1A1.
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.
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.
Limited data are available on the development of resistance to atazanavir boosted with cobicistat.
Podatki o razvoju odpornosti pri uporabi atazanavirja, okrepljenega s kobicistatom, so omejeni.
Cobicistat is a strong mechanism-based CYP3A inhibitor and a weak CYP2D6 inhibitor.
Kobicistat je močan zaviralec mehanizma CYP3A in šibek zaviralec CYP2D6.
Cobicistat is a CYP3A substrate and is metabolised to a minor extent by CYP2D6.
Kobicistat je substrat za CYP3A in se v manjšem obsegu presnavlja s CYP2D6.
Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate.
Kobicistat je močan zaviralec mehanizma CYP3A in tudi substrat za CYP3A.
Plasma levels of cobicistat and consequently of atazanavir may decrease significantly during pregnancy.
Med nosečnostjo se lahko pomembno zmanjšajo plazemske koncentracije kobicistata in posledično tudi atazanavirja.
The mechanism of interaction is inhibition of metabolism by atazanavir.
Mehanizem interakcije je zaviranje presnove z atazanavirjem.
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).
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.
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).
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).
Co-administration of tenofovir DF with cobicistat is expected to increase tenofovir plasma concentrations.
Pri sočasni uporabi tenofovirja DF in kobicistata pričakujemo povečanje koncentracij tenofovirja v plazmi.
Sofosbuvir 400 mg/velpatasvir, 100 mg/voxilaprevir 100 mg single dose* (atazanavir 300 mg with ritonavir 100 mg once daily)
Sofosbuvir 400 mg/velpatasvir, 100 mg/voksilaprevir 100 mg enkratni odmerek* (atazanavir 300 mg z ritonavirjem 100 mg enkrat na dan)
The mechanism of interaction is inhibition of CYP2D6 by cobicistat.
Mehanizem interakcije je zaviranje CYP2D6 s kobicistatom.
Raltegravir 400 mg twice daily (atazanavir 400 mg)
Raltegravir 400 mg dvakrat na dan (atazanavir 400 mg)
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.
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.
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)
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)
Increase monitoring for adverse reactions.
Potrebno je pogostejše nadziranje neželenih učinkov.
Nervous system disorders common headache, dizziness, somnolence, dysgeusia uncommon peripheral neuropathy, syncope, amnesia
Bolezni živčevja pogosti glavobol, omotica, somnolenca, paragevzija občasni periferna nevropatija, sinkopa, anmnezija
No human data on the effect of cobicistat on fertility are available.
Podatkov o vplivu kobicistata na plodnost pri človeku ni.
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.
Če boste zdravilo jemali natančno po zdravnikovih navodilih, bo dosežena polna učinkovitost zdravila, tveganje za razvoj odpornosti virusa HIV pa se bo zmanjšalo.
Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Kobicistat je selektivni zaviralec encimskega mehanizma poddružine CYP3A citokroma P450.
Cobicistat, a component of EVOTAZ, has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Za kobicistat, sestavino zdravila EVOTAZ, se je izkazalo, da zmanjša ocenjeni kreatininski očistek, kar je posledica zaviranja tubulne sekrecije kreatinina.
No data are available on the pharmacokinetics of atazanavir and cobicistat in combination in paediatric patients.
Podatki o farmakokinetiki atazanavirja in kobicistata v kombinaciji pri pediatričnih bolnikih niso na voljo.
Didanosine (enteric coated capsules) 400 mg single dose (atazanavir 400 mg once daily)
Didanozin (gastrorezistentne kapsule) 400 mg enkratni odmerek (atazanavir 400 mg enkrat na dan)
Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Kobicistat za razliko od ritonavirja ni induktor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali UGT1A1.
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.
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.
NAME OF THE MEDICINAL PRODUCT EVOTAZ 300 mg/150 mg film-coated tablets
EVOTAZ 300 mg/150 mg filmsko obložene tablete 2.
Hepatobiliary disorders very common jaundice common hyperbilirubinaemia uncommon hepatitis, cholelithiasisa, cholestasisa rare hepatosplenomegaly, cholecystitisa
Bolezni jeter, žolčnika in žolčevodov zelo pogosti zlatenica pogosti hiperbilirubinemija občasni hepatitis, holelitiazaa, holestazaa redki hepatosplenomegalija, holecistitsa
Co-administration with EVOTAZ has the potential to produce serious and/or life-threatening bleeding due to increased exposure to warfarin and has not been studied.
Pri sočasni uporabi zdravila EVOTAZ se lahko pojavijo resne in/ali smrtno nevarne krvavitve zaradi povečane izpostavljenosti varfarinu.
Co-administration of EVOTAZ and elbasvir/grazoprevir is contraindicated because of the expected increase in grazoprevir plasma concentrations and the associated potential increase in the risk of ALT elevations (see section 4.3).
Sočasna uporaba zdravila EVOTAZ in elbasvirja/grazoprevirja je kontraindicirana zaradi pričakovanega povečanja koncentracij grazoprevirja v plazmi in s tem povezanega možnega večjega tveganja za zvišanje vrednosti ALT (glejte poglavje 4.3).
There were no tumorigenic findings in male mice or in rats.
Pri samcih miši ali podgan tumorogenih sprememb niso odkrili.
Co-administration with EVOTAZ has the potential to produce serious and/or life-threatening adverse reactions.
Pri sočasni uporabi zdravila EVOTAZ se lahko pojavijo resni in/ali smrtno nevarni neželeni učinki.
(atazanavir 300 mg once daily with cobicistat 150 mg once daily)
(atazanavir 300 mg enkrat na dan s kobicistatom 150 mg enkrat na dan)
If you feel dizzy or lightheaded, please contact your doctor immediately.
V primeru omotice ali vrtoglavice se nemudoma posvetujte z zdravnikom.
Because atazanavir is a component of EVOTAZ, co-administration of EVOTAZ with nevirapine or efavirenz is not recommended (see section 4.5).
Zdravilo EVOTAZ vsebuje atazanavir, zato sočasna uporaba zdravila EVOTAZ in nevirapina ali efavirenza ni priporočljiva (glejte poglavje 4.5).
Tenofovir disoproxil fumarate (tenofovir DF) 300 mg once daily (atazanavir 400 mg once daily)
Dizoproksiltenofovirijev fumarat (tenofovir DF) 300 mg enkrat na dan (atazanavir 400 mg enkrat na dan)
For more information consult the cobicistat Summary of Product Characteristics.
Za več informacij glejte povzetek glavnih značilnosti zdravila za kobicistat.
In study GS-US-216-0114, the mean increase from baseline in CD4+ cell count at weeks 48 and 144 were 213 and 310 cells/mm3 in patients receiving atazanavir boosted with cobicistat and 219 and 332 cells/mm3 in patients receiving atazanavir boosted with ritonavir, respectively.
V študiji GS-US-216-0114 je povprečno povečanje števila celic CD4+ od izhodišča pri bolnikih, ki so prejemali atazanavir, okrepljen s kobicistatom, v 48. tednu znašalo 213 celic/mm3, v 144. tednu pa 310 celic/mm3.
Co-administration of EVOTAZ and these antiepileptics is contraindicated (see section 4.3).
Sočasna uporaba zdravila EVOTAZ in teh antiepileptikov je kontraindicirana (glejte poglavje 4.3).
The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat.
Mehanizem interakcije je zaviranje CYP3A4 in/ali CYP2D6 z atazanavirjem in/ali kobicistatom.
Atazanavir has been studied in adult patients with severe renal impairment (n=20), including those on haemodialysis, at multiple doses of 400 mg once daily.
Uporabo atazanavirja so raziskovali pri odraslih bolnikih s hudo okvaro ledvic (n=20), vključno z bolniki, ki so se zdravili s hemodializo.
Drospirenone/ethinyloestradiol 3 mg/0.02 mg single dose (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Drospirenon/etinilestradiol 3 mg/0,02 mg enkratni odmerek (atazanavir 300 mg enkrat na dan s kobicistatom 150 mg enkrat na dan)
Neither metabolite demonstrated in vitro antiviral activity.
Nobeden od presnovkov in vitro ni imel protivirusnega učinka.
Rifabutin 150 mg every other day/elvitegravir 150 mg once daily/cobicistat 150 mg once daily
Rifabutin 150 mg vsak drugi dan/elvitegravir 150 mg enkrat na dan/kobicistat 150 mg enkrat na dan
EVOTAZ must not be used in patients with moderate to severe hepatic impairment (see section 4.3).
Pri bolnikih z zmerno do hudo okvaro jeter se zdravila EVOTAZ ne sme uporabljati (glejte poglavje 4.3).
Maraviroc is not expected to have an impact on concentrations of atazanavir and cobicistat.
Vpliva maraviroka na koncentracije atazanavirja in kobicistata ni pričakovati.
Atazanavir should be used with caution in patients with mild (Child-Pugh Class A) hepatic impairment.
Pri bolnikih z blago (Child-Pugh A) okvaro jeter je treba atazanavir uporabljati previdno, pri bolnikih z zmerno (Child-Pugh B) do hudo (Child-Pugh C) okvaro jeter pa se atazanavirja ne sme uporabljati.
Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with the use of atazanavir (see section 4.4).
Pri bolnikih, ki so se zdravili z atazanavirjem, so poročali o pojavu Stevens-Johnsonovega sindroma, multiformnega eritema, toksičnih izbruhov na koži in sindroma medikamentoznega izpuščaja z eozinofilijo in s sistemskimi simptomi (DRESS) (glejte poglavje 4.4).
How to store EVOTAZ
Kako jemati zdravilo EVOTAZ
The mechanism of interaction is inhibition of P-gp by cobicistat.
Mehanizem interakcije je zaviranje P-gp s kobicistatom.
Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Dokazano je bilo, da kobicistat zmanjša ocenjeni kreatininski očistek, kar je posledica zaviranja tubulne sekrecije kreatinina.
No teratogenic effects were observed in rats and rabbit developmental toxicity studies.
V študijah vplivov na razvoj pri podganah in kuncih niso opazili teratogenih učinkov.
The active substances are atazanavir and cobicistat.
Učinkovini sta atazanavir in kobicistat.
The mechanism of interaction is CYP3A4 inhibition by atazanavir, cobicistat and ketoconazole or itraconazole.
Mehanizem interakcije je zaviranje CYP3A4 z atazanavirjem, kobicistatom in ketokonazolom ali itrakonazolom.
Omeprazole 40 mg once daily (atazanavir 400 mg once daily, 2 hours after omeprazole)
Omeprazol 40 mg enkrat na dan (atazanavir 400 mg enkrat na dan, 2 uri po omeprazolu)
Co-administration of etravirine and EVOTAZ is expected to decrease atazanavir and cobicistat plasma concentrations.
Pri sočasni uporabi etravirina in zdravila EVOTAZ pričakujemo zmanjšanje koncentracij atazanavirja in kobicistata v plazmi.
Co-administration of salmeterol with EVOTAZ is not recommended (see section 4.4).
Sočasna uporaba salmeterola in zdravila EVOTAZ ni priporočljiva (glejte poglavje 4.4).
With Tenofovir DF 300 mg once daily Famotidine 20 mg twice daily (atazanavir 300 mg/ritonavir 100 mg/tenofovir DF 300 mg once daily, simultaneous administration)
S tenofovirjem DF v odmerku 300 mg enkrat na dan Famotidin 20 mg dvakrat na dan (atazanavir 300 mg/ritonavir 100 mg/tenofovir DF 300 mg enkrat na dan, sočasna uporaba)
Effect of cobicistat on atazanavir pharmacokinetics
Vpliv kobicistata na farmakokinetiko atazanavirja
Because atazanavir is a component of EVOTAZ, the combination of EVOTAZ with atorvastatin is not recommended (see section 4.5).
Zdravilo EVOTAZ vsebuje atazanavir, zato zdravila EVOTAZ ni priporočljivo uporabljati v kombinaciji z atorvastatinom (glejte poglavje 4.5).
Atazanavir and fluconazole concentrations were not significantly modified when atazanavir/ritonavir was co-administered with fluconazole.
Pri sočasni uporabi atazanavirja/ritonavirja in flukonazola se koncentracije atazanavirja in flukonazola niso pomembneje spremenile.
Patients should not breast-feed while taking EVOTAZ.
Bolnice med zdravljenjem z zdravilom EVOTAZ ne smejo dojiti.
Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving EVOTAZ should be evaluated for alternative etiologies.
Če se pri bolniku, ki se zdravi z zdravilom EVOTAZ, pojavi zvišanje vrednosti jetrnih aminotransferaz, ki jih spremlja zvišanje vrednosti bilirubina, je treba ugotoviti morebitne druge vzroke.
Atazanavir demonstrates nonlinear pharmacokinetics with greater than dose-proportional increases in AUC and Cmax values over the dose range of 200 mg to 800 mg once daily.
V razponu odmerkov od 200 mg do 800 mg enkrat na dan se vrednosti AUC in Cmax povečajo bolj kot proporcionalno z odmerkom.
Clinical monitoring is recommended upon co-administration with EVOTAZ.
Pri sočasni uporabi zdravila EVOTAZ priporočamo klinični nadzor.
Uncommon (may affect up to 1 in 100 people) torsade de pointes (life threatening irregular heart beat) hypersensitivity (allergic reaction) anorexia (loss of appetite), weight loss, weight gain depression, anxiety, sleep disorder disorientation, amnesia (loss of memory) peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores) hepatitis (inflammation of the liver) angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) urticaria (itchy rash), alopecia (unusual hair loss or thinning), pruritus (itching) muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles) nephrolithiasis (formation of kidney stones), interstitial nephritis (kidney inflammation), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination), chronic kidney disease (how well your kidneys work) gynaecomastia (breast enlargement in men) chest pain, malaise (generally feeling unwell), fever asthenia (unusual tiredness or weakness) serious skin rashes (allergic reactions including rash, a high temperature, increased levels of liver enzymes seen in blood tests, an increase in a type of white blood cell [esosinophilia] and/or enlarged lymph nodes) (see section 2) gallbladder disorders (gallstones and gallbladder inflammation)
angioedem (hudo otekanje kože in drugih tkiv, najpogosteje ustnic ali oči) koprivnica (srbeč kožni izpuščaj), alopecija (neobičajno izpadanje ali redčenje las), pruritus (srbenje) mišična atrofija (zmanjšanje mišične mase), artralgija (bolečina v sklepu), mialgija (bolečina v mišicah) nefrolitiaza (nastanek ledvičnih kamnov), intersticijski nefritis (vnetje ledvic), hematurija (kri v urinu), proteinurija (presežek beljakovin v urinu), polakisurija (pogosto uriniranje), kronična ledvična bolezen (kako dobro delujejo vaše ledvice) ginekomastija (povečanje dojk pri moških) bolečine v prsnem košu, splošno slabo počutje, zvišana telesna temperatura astenija (neobičajna utrujenost ali oslabelost) resni kožni izpuščaji (alergijska reakcija s kožnim izpuščajem, zvišano telesno temperaturo, zvišano vrednostjo jetrnih encimov, ugotovljenih pri krvnih preiskavah, povečanjem števila določene vrste belih krvnih celic [eozinofilija] in/ali povečanjem bezgavk) (glejte poglavje 2) bolezni žolčnika (žolčni kamni in vnetje žolčnika)
It is not recommended to co-administer EVOTAZ with simeprevir.
Zdravila EVOTAZ ni priporočljivo uporabljati skupaj s simeprevirjem.
There are no pharmacokinetic data available for atazanavir in combination with cobicistat in patients with renal insufficiency.
Farmakokinetični podatki o uporabi atazanavirja v kombinaciji s kobicistatom pri bolnikih z okvaro delovanja ledvic niso na voljo.
Efavirenz 600 mg single dose (cobicistat 150 mg once daily)
Efavirenz 600 mg enkratni odmerek (kobicistat 150 mg enkrat na dan)
Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
Ne pričakujemo, da bi kobicistat zaviral CYP1A2, CYP2B6, CYP2C8, CYP2C9 ali CYP2C19.
ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Klaritromicin 500 mg dvakrat na dan (atazanavir 400 mg enkrat na dan)
Co-administration of EVOTAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3).
Sočasna uporaba zdravila EVOTAZ in fiksne kombinacije glekaprevir/pibrentasvir je kontraindicirana zaradi možnega večjega tveganja za zvišanje vrednosti ALT zaradi pomembnega povečanja koncentracij glekaprevirja in pibrentasvirja v plazmi (glejte poglavje 4.3).
For medicinal products metabolised by CYP3A these higher plasma concentrations may potentially lead to severe, life-threatening or fatal events (see sections 4.3 and 4.5).
Zaradi povečanja plazemskih koncentracij sočasno uporabljenih zdravil, ki se presnavljajo s CYP3A, se lahko okrepijo ali podaljšajo terapevtski učinki teh zdravil ali pojavijo njihovi neželeni učinki, vključno s hudimi, smrtno nevarnimi ali usodnimi dogodki (glejte poglavji 4.3 in 4.5).
The demographic and baseline characteristics were similar between the atazanavir with cobicistat and atazanavir with ritonavir groups.
Demografske lastnosti bolnikov in izhodiščne značilnosti bolezni so bile v skupini, ki je prejemala atazanavir s kobicistatom, podobne kot v skupini, ki je prejemala atazanavir z ritonavirjem.
No clinically relevant pharmacokinetic differences due to gender have been identified for atazanavir or cobicistat.
Klinično pomembnih razlik v farmakokinetiki atazanavirja ali kobicistata glede na spol niso ugotovili.
Vascular disorders uncommon hypertension
Žilne bolezni občasni hipertenzija
Adverse Reactions uncommon myalgia, muscle atrophy, arthralgia rare myopathy
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mialgija, mišična atrofija, artralgija redki miopatija
The mechanism of interaction is CYP3A and/or P-glycoprotein inhibition by atazanavir and cobicistat.
Mehanizem interakcije je zaviranje CYP3A in/ali P-glikoproteina z atazanavirjem in kobicistatom.
Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving atazanavir.
Pri bolnikih, ki so se zdravili z atazanavirjem, so poročali o pojavu Stevens-Johnsonovega sindroma, multiformnega eritema, toksičnih izbruhov na koži in sindroma medikamentoznega izpuščaja z eozinofilijo in sistemskimi simptomi (DRESS; “drug rash with eosinophilia and systemic symptoms”).
EVOTAZ is expected to increase rilpivirine plasma concentrations.
Pričakovati je, da bo zdravilo EVOTAZ povečalo koncentracije rilpivirina v plazmi.
The co-administration of EVOTAZ with stavudine is not expected to significantly alter the exposure of stavudine.
Pri sočasni uporabi zdravila EVOTAZ s stavudinom pomembnejših sprememb v izpostavljenosti stavudinu ne pričakujemo.
The effects of hepatic impairment on the pharmacokinetics of atazanavir given with cobicistat have not been studied.
Vpliva okvare jeter na farmakokinetiko atazanavirja pri uporabi skupaj s kobicistatom niso raziskovali.