natgillin/translations-raw huggingface dataset:
Co-administration of atazanavir /ritonavir with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate has not been studied, and therefore should be avoided.
Istovremena primjena atazanavira s ritonavirom i druge hormonske ili oralne kontracepcije koja sadrži progestagene, osim norgestimata, nije ispitana i stoga je treba izbjegavati.
Diltiazem 180 mg once daily
Diltiazem 180 mg jedanput na dan
The atazanavir/ritonavir arm showed similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48 (Table 5).
U skupini koja je primala atazanavir/ritonavir utvrđena je antivirusna djelotvornost slična (neinferiorna) onoj u skupini koja je primala lopinavir/ritonavir, što je procijenjeno na temelju udjela bolesnika s HIV RNK < 50 kopija/ml u 48. tjednu (tablica 5).
Atazanavir may affect how well your kidneys work.
Atazanavir može utjecati na to kako dobro rade vaši bubrezi.
Due to carbamazepine inducing effect, a reduction in atazanavir exposure cannot be ruled out.
Zbog inducirajućeg učinka karbamazepina, ne može se isključiti smanjena izloženost atazanaviru.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Za nadzor lipida i glukoze u krvi date su preporuke u su u utvrđenim smjernicama za liječenje HIV-a.
Atazanavir has been detected in human milk.
Atazanavir je pronađen u majčinom mlijeku.
The studies presented in Table 2 were conducted in healthy subjects unless otherwise noted.
Ako nije drugačije naznačeno, ispitivanja prikazana u tablici 2 provedena su u zdravih ispitanika.
Week 48 Week 96 Week 48 Week 96 Week 48 Week 96 HIV RNA Mean Change from Baseline, log10 copies/ml All patients
d] 48. tjedan 96. tjedan 48. tjedan 96. tjedan 48. tjedan 96. tjedan HIV RNK prosječna promjena u odnosu na početnu vrijednost, log10 kopija/ml
Atazanavir (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 ChildPugh Class C subjects) after a single 400 mg dose.
Atazanavir (bez ritonavira) ispitivao se u odraslih ispitanika s umjerenim do teškim oštećenjem funkcije jetre (14 ispitanika s Child-Pugh stadijem B i 2 ispitanika s Child-Pugh stadijem C) nakon primjene jednokratne doze od 400 mg.
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily
Nenukleozidni inhibitori reverzne transkriptaze (NNRTI-jevi) Efavirenz 600 mg jedanput na dan
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Autoimune bolesti (kao što je Gravesova bolest i autoimunog hepatitisa) su također bile prijavljene; međutim, vrijeme prijave pojave tih bolesti je vrlo varijabilno jer se mogu dogoditi i više mjeseci nakon početka liječenja. (vidjeti dio 4.4).
PI major L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
Glavna supstitucija za rezistenciju na inhibitore proteaze L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; sporedna supstitucija za rezistenciju na inhibitore proteaze: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of treatment may be considered.
Ako se pojave znakovi i simptomi nefrolitijaze, može se razmotriti privremeni ili trajni prekid liječenja.
A dose equivalent to famotidine 40 mg twice daily should not be exceeded.
Ne smije se prekoračiti doza jednaka dozi famotidina od 40 mg dvaput na dan.
Ketoconazole and itraconazole should be used cautiously with atazanavir/ritonavir.
Ketokonazol i itrakonazol treba primjenjivati s oprezom kad se daju s atazanavirom/ritonavirom.
Co-administration with atazanavir with ritonavir warrants clinical monitoring for sedation and cognitive effects.
Istovremena primjena s atazanavirom i ritonavirom zahtijeva kliničko praćenje zbog sedacije i kognitivnih učinaka.
Other medicines and Atazanavir Mylan
Drugi lijekovi i Atazanavir Mylan
Irinotecan
Irinotekan
ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics
ANTINEOPLASTICI I IMUNOSUPRESIVI
• atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol)
• atorvastatin, pravastatin i fluvastatin (primjenjuju se za snižavanje kolesterola u krvi)
Among patients receiving atazanavir 300 mg with ritonavir 100 mg, the frequency of jaundice was 19%.
Među bolesnicima koji su primali atazanavir 300 mg s ritonavirom 100 mg, učestalost žutice bila je 19%.
Co-administration of atazanavir and ritonavir with food optimises the bioavailability of atazanavir.
Istovremena primjena atazanavira i ritonavira s hranom optimizira bioraspoloživost atazanavira.
• viral strains not harbouring HIV resistance-associated mutations (RAMs) to current regimen.
• virusni sojevi koji nisu nositelji mutacija povezanih s rezistencijom HIV-a na trenutni režim liječenja.
Systemic exposures of atazanavir in mice (males), rats, and dogs at doses associated with hepatic changes were at least equal to that observed in humans given 400 mg once daily.
Sistemska izloženost miševa (mužjaka), štakora i pasa atazanaviru primijenjenom u dozama koje su povezane s jetrenim promjenama bila je barem jednaka onoj opaženoj u ljudi koji su dobivali 400 mg jedanput na dan.
The increase in progestin exposure may lead to related side-effects (e.g. insulin resistance, dyslipidemia, acne and spotting), thus possibly affecting the compliance.
Povećana izloženost progestinu može dovesti do s time povezanih nuspojava (npr. inzulinske rezistencije, dislipidemije, akni i probojnog krvarenja) i tako utjecati na uzimanje kontracepcije.
In some cases, nephrolithiasis has been associated with acute renal failure or renal insufficiency.
U nekim slučajevima, nefrolitijaza je povezana s akutnim zatajenjem bubrega ili bubrežnom insuficijencijom.
• grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection).
• lijekovi koji sadrže grazoprevir, uključujući fiksnu kombinaciju elbasvira/grazoprevira (koja se koristi u liječenju kronične infekcije virusom hepatitisa C).
≥ 200 cells/mm
≥ 200 stanica /mm
common: vomiting, diarrhoea, abdominal pain, nausea, dyspepsia; uncommon: pancreatitis, gastritis, abdominal distension, stomatitis aphthous, flatulence, dry mouth
često: povraćanje, proljev, bol u abdomenu, mučnina, dispepsija; manje često: pankreatitis, gastritis, distenzija abdomena, aftozni stomatitis, flatulencija, suha usta
14-OH clarithromycin AUC ↓70%
14-OH klaritromicin AUC ↓70%
Only when atazanavir with ritonavir is co-administered with efavirenz, a dose increase of ritonavir to 200 mg once daily could be considered.
Samo kad se atazanavir s ritonavirom primjenjuje istovremeno s efavirenzom može se razmotriti povišenje doze ritonavira na 200 mg jedanput na dan.
Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Dva posto bolesnika liječenih atazanavirom imalo je istovremeno ALT/AST 3.-4. stupnja i povišenje ukupnog bilirubina 3.-4. stupnja.
No dosage adjustments are needed for fluconazole and atazanavir.
Nisu potrebne prilagodbe doze flukonazola i atazanavira.
uncommon: muscle atrophy, arthralgia, myalgia; rare: myopathy
manje često: mišićna atrofija, artralgija, mialgija; rijetko: miopatija
Patients should not breast-feed while taking Atazanavir Mylan.
Bolesnice ne smiju dojiti dok uzimaju Atazanavir Mylan.
Itraconazole
Itrakonazol
If a higher dose of an H2-receptor antagonist is required (e.g., famotidine 40 mg twice daily or equivalent) an increase of the atazanavir/ritonavir dose from 300/100 mg to 400/100 mg can be considered.
Ako je potrebna viša doza antagonista H2 receptora (npr., famotidin 40 mg dvaput na dan ili ekvivalent) može se razmotriti povišenje doze lijeka atazanavir s ritonavirom s 300/100 mg na 400/100 mg.
Atazanavir Mylan, co-administered with low dose ritonavir, is indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).
Atazanavir Mylan, primijenjen istovremeno s niskom dozom ritonavira, indiciran je u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje odraslih i pedijatrijskih bolesnika u dobi od 6 godina i starijih, koji su zaraženi virusom HIV 1 (vidjeti dio 4.2).
Unchanged drug accounted for approximately 20% and 7% of the administered dose in the faeces and urine, respectively.
Neizmijenjeni lijek činio je približno 20% primijenjene doze u stolici, a 7% u mokraći.
In clinical study AI424-020, paediatric patients 3 months to less than 18 years of age who received either the oral powder or capsule formulation had a mean duration of treatment with atazanavir of 115 weeks.
U kliničkom ispitivanju AI424-020 u pedijatrijskih bolesnika u dobi od 3 mjeseca do manje od 18 godina koji su primali ili oblik oralnog prašaka ili oblik kapsule, medijan trajanja liječenja iznosio je 115 tjedana.
The geometric mean (CV%) for atazanavir Cmin and AUC was 654 (76%) ng/ml and 44185 (51%) ng•h/ml, respectively.
Geometrijska sredina (CV%) Cmin atazanavira iznosila je 654 (76%) ng/ml, a AUC atazanavira 44185 (51%) ng•h/ml.
In a small number of patients without a functional CYP2C19 allele, significantly increased voriconazole exposures are expected (see section 4.5).
U malog broja bolesnika bez funkcionalnog CYP2C19 alela očekuje se značajno povećanje izloženosti vorikonazolu (vidjeti dio 4.5).
Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily
Nukleozidni/nukleotidni inhibitori reverzne transkriptaze (NRTI-jevi) Lamivudin 150 mg dvaput na dan + zidovudin 300 mg dvaput na dan
Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.8).
Redovito praćenje bubrežnih funkcija u bolesnika treba se održavati tijekom cijelog trajanja liječenja (pogledajte dio4.8).
Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway, e.g., budesonide.
Sistemski učinci kortikosteroida, uključujući Cushingov sindrom i supresiju nadbubrežne žlijezde, zabilježeni su u bolesnika koji su primali ritonavir i inhalirali ili intranazalno primjenjivali flutikazon propionat; to se može dogoditi i s drugim kortikosteroidima koji se metaboliziraju putem P450
The co-administration of abacavir and atazanavir is not expected to significantly alter the exposure of abacavir.
Ne očekuje se da će istovremena primjena abakavira i atazanavira značajno promijeniti izloženost abakaviru.
They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system.
Djeluju tako što smanjuju količinu HIVa u Vašem tijelu, što jača
The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of atazanavir /ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours.
Smanjenje AUC, Cmax i Cmin nije bilo ublaženo privremenim vremenskim razmakom između povišene doze atazanavira s ritonavirom (400/100 mg jedanput na dan) i omeprazola od 12 sati.
Atazanavir given without ritonavir should not be considered in patients treated with a backbone regimen containing tenofovir disoproxil and with other concomitant medications that reduce atazanavir bioavailability (see section 4.5 In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen) or in case of perceived challenging compliance.
Primjena atazanavira bez ritonavira ne smije se razmatrati u bolesnika liječenih osnovnim režimom koji sadrži tenofovirdizoproksil i drugim istovremeno primjenjivanim lijekovima koji smanjuju bioraspoloživost atazanavira (vidjeti odlomak 'Ako se ritonavir izostavi iz preporučenog režima liječenja atazanavirom pojačanim ritonavirom' u dijelu 4.5), kao ni u bolesnika za koje se smatra da bi mogli imati poteškoća s pridržavanjem liječenja.
Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Deset bolesnika imalo je na početku fenotipsku rezistenciju na atazanavir s ritonavirom (promjena ekspresije [FC] >5,2 puta).
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported;
Prijavljena je pojava autoimunih bolesti (kao Gravesova bolest i autoimunog hepatitisa ) kao dio imunološke reaktivacije.
- The other ingredients are lactose monohydrate (see section 2, ‘Atazanavir Mylan contains lactose'), crospovidone, magnesium stearate.
- Drugi su sastojci laktoza hidrat, (vidjeti dio 2 „Atazanavir Mylan sadrži laktozu”), krospovidon, magnezijev stearat.
Coadministration of a single 300 mg dose of atazanavir and 100 mg dose of ritonavir with a light meal resulted in a 33% increase in the AUC and a 40% increase in both the Cmax and the 24 hour concentration of atazanavir relative to the fasting state.
Istovremena primjena jednokratne doze atazanavira od 300 mg i doze ritonavira od 100 mg uz lagani obrok rezultirala je povećanjem AUC-a za 33% i povećanjem Cmax i 24-satne koncentracije atazanavira za 40% u odnosu na primjenu natašte.
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), Atazanavir Mylan should be used with caution and only if the benefits exceed the risk (see section 5.1).
U bolesnika s već prisutnim poremećajima provođenja (atrioventrikularni blok drugog ili višeg stupnja ili kompletni blok grane) Atazanavir Mylan treba primjenjivati s oprezom i samo ako su koristi od liječenja veće od rizika (vidjeti dio 5.1).
- in patients with at least one functional CYP2C19 allele, close clinical monitoring for a loss of both voriconazole (clinical signs) and atazanavir (virologic response) efficacy is recommended.
- za bolesnike s najmanje jednim funkcionalnim CYP2C19 alelom preporučuje se poman klinički nadzor kako bi se uočio eventualni gubitak djelotvornosti vorikonazola (klinički znakovi) i atazanavira (virološki odgovor).
Mean urinary excretion of unchanged drug was 7% following 2 weeks of dosing at 800 mg once daily.
Prosječno se 7% lijeka izlučilo mokraćom u neizmijenjenom obliku nakon 2 tjedna primjene doze od 800 mg jedanput na dan.
• simvastatin and lovastatin (used to lower blood cholesterol).
• simvastatin i lovastatin (primjenjuju se za snižavanje kolesterola u krvi)
• It is not recommended to use atazanavir with ritonavir for pregnant patients who are receiving both tenofovir disoproxil and an H2-receptor antagonist.
• Ne preporučuje se primjenjivati atazanavir s ritonavirom u trudnica koje primaju i tenofovirdizoproksil i antagonist
In previous studies, the pharmacokinetics of atazanavir was not altered by rifabutin.
U prethodnim ispitivanjima, rifabutin nije promijenio farmakokinetiku atazanavira.
HIV RNA <100,000 copies/ml
HIV RNK <100 000 kopija/ml
Co-administration with atazanavir has the potential to increase or decrease warfarin concentrations.
Istovremena primjena s atazanavirom može povisiti ili sniziti koncentracije varfarina.
This effect may be due to an induction of CYP3A4.
Taj učinak možda nastaje zbog indukcije enzima CYP3A4.
Concentrations of these antiarrhythmics may be increased when co-administered with atazanavir.
Koncentracije ovih antiaritmika mogu biti povišene kad se primjenjuju istovremeno s atazanavirom.
Co-administration with simvastatin or lovastatin (see section 4.5).
Istovremena primjena sa simvastatinom ili lovastatinom (vidjeti dio 4.5).
In a fertility and early embryonic development study in rats, atazanavir altered oestrus cycling with no effects on mating or fertility.
U ispitivanju učinaka na plodnost i rani embrionalni razvoj, atazanavir je promijenio ciklus estrusa bez učinaka na parenje ili plodnost.
110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60) NA
CD4 prosječna promjena od početne vrijednosti, stanice/mm Svi bolesnici 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60) NP
Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Od 1151 bolesnika koji su primali atazanavir 400 mg jedanput na dan, 177 bolesnika istovremeno je imalo kroničnu infekciju virusom hepatitisa B ili C, dok je od 655 bolesnika koji su primali atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan, 97 bolesnika istovremeno imalo kroničnu infekciju virusom B ili C.
Through 96 weeks of treatment, mean HIV RNA changes from baseline for atazanavir + ritonavir and lopinavir + ritonavir met criteria for non-inferiority based on observed cases.
Nakon 96 tjedana liječenja, prosječna promjena razine HIV RNK u odnosu na početnu vrijednost uz atazanavir s ritonavirom i lopinavir s ritonavirom zadovoljila je kriterij neinferiornosti na temelju opaženih slučajeva.
QT prolongation
Produljenje QT intervala
1 hour before taking Atazanavir Mylan or 2 hours after taking Atazanavir Mylan, H2-blockers like famotidine and proton pump inhibitors like omeprazole)
Atazanavir Mylan, H2-blokatore kao famotidin ili inhibitore protonske pumpe kao omeprazol)
Atazanavir and fluconazole concentrations were not significantly modified when Atazanavir /ritonavir was co-administered with fluconazole.
Koncentracije atazanavira i flukonazola nisu bile značajno promijenjene kad se atazanavir s ritonavirom primjenjivao istovremeno s flukonazolom.
Amiodarone, Systemic lidocaine, Quinidine
Sistemski lidokain, Kinidin
uncommon: weight decreased, weight gain, anorexia, appetite increased
manje često: smanjenje tjelesne težine, povećanje tjelesne težine, anoreksija, pojačan apetit
The recommended dose of Atazanavir Mylan capsules for adults is 300 mg once daily with 100 mg ritonavir once daily, taken with food, in combination with other anti-HIV medicines.
Preporučena doza Atazanavir Mylan kapsula za odrasle je 300 mg jedanput na dan sa 100 mg ritonavira jedanput na dan i s hranom, u kombinaciji s drugim anti-HIV lijekovima.
For treatment-experienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm
U prethodno liječenih pedijatrijskih bolesnika, prosječni početni broj CD4 stanica iznosio je 522 stanica/mm
HIV RNA <50 copies/ml, % All patients d
HIV RNK <50 kopija/ml, % Svi bolesnici d
Concomitant use of salmeterol and Atazanavir Mylan may result in increased cardiovascular adverse events associated with salmeterol.
Istovremena primjena salmeterola i lijeka Atazanavir Mylan može rezultirati pojačanim kardiovaskularnim nuspojavama salmeterola.
Carbamazepine should be used with caution in combination with atazanavir.
Karbamazepin se mora primjenjivati uz oprez u kombinaciji s atazanavirom.
Co-administration of lurasidone with atazanavir is contraindicated as this may increase lurasidone-related toxicity (see section 4.3).
Istodobna primjena lurasidona s atazanavirom kontraindicirana je jer može povećati toksičnost povezanu s primjenom lurasidona (vidjeti dio 4.3.).
• disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream
• dezorijentacija, amnezija (gubitak pamćenja), omaglica, somnolencija (izrazita pospanost),
What you need to know before you take Atazanavir Mylan
Što morate znati prije nego počnete uzimati Atazanavir Mylan
In HIV-infected patients (n=13), multiple dosing of atazanavir 400 mg (without ritonavir) once daily with food produced a geometric mean (CV%) for atazanavir Cmax of 2298 (71) ng/ml, with time to Cmax of approximately 2.0 hours.
U bolesnika zaraženih HIV-om (n=13), višestruka primjena atazanavira u dozi od 400 mg (bez ritonavira) jedanput na dan s hranom dovela je do geometrijske srednje vrijednosti (CV%) Cmax atazanavira od 2298 (71) ng/ml, uz vrijeme do postizanja Cmax od približno 2,0 sati.
Atazanavir Mylan with ritonavir should be used with caution in patients with mild hepatic impairment.
Atazanavir Mylan s ritonavirom treba primjenjivati s oprezom u bolesnika s blagim oštećenjem funkcije jetre.
• medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
• lijekove koji sadrže gospinu travu (Hypericum perforatum, biljni pripravak)
The most frequently reported laboratory abnormalities in paediatric patients receiving atazanavir oral powder was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4; 16%) and increased amylase (Grade 3-4; 33%), generally of non-pancreatic origin.
Najčešće zabilježeni poremećaj laboratorijskih nalaza u pedijatrijskih bolesnika koji su primali atazanavir oralni prašak bilo je povišenje ukupnog bilirubina (≥ 2,6 GGN, 3.-4. stupanj; 16%) i povišena vrijednost amilaze (3.-4. stupanj; 33%), općenito porijekla koje nije povezano s gušteračom.
Co-administration of quetiapine with atazanavir is contraindicated as atazanavir may increase quetiapine-related toxicity.
Istodobna primjena kvetiapina i atazanavira je kontraindicirana jer atazanavir može povećati toksičnost povezanu s primjenom kvetiapina.
If the combination is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Ako se prosudi da je ta kombinacija neizbježna, preporučuje se pažljiv klinički nadzor u kombinaciji s povišenjem doze atazanavira na 400 mg sa 100 mg ritonavira; ne smiju se prekoračiti doze inhibitora protonske pumpe usporedive s dozom omeprazola od 20 mg (vidjeti dio 4.4).
Total rifabutin and 25-O-desacetylrifabutin AUC ↑119% (↑78%
AUC ukupnog rifabutina i 25-Odezacetil-rifabutina ↑119% (↑78%
Atazanavir Mylan dose once daily (mg)
Doza lijeka Atazanavir Mylan jedanput na dan (mg)
No dosage adjustment is necessary if methadone is co-administered with atazanavir.
Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s atazanavirom.
Therefore, Atazanavir Mylan is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Stoga je Atazanavir Mylan kontraindicirano primijeniti s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski raspon, kao što su: kvetiapin, lurasidon, alfuzozin, astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralno primijenjen midazolam i alkaloidi ergota, osobito ergotamin i dihidroergotamin (vidjeti dio 4.3).
In female mice, atazanavir exposure at a dose that produced single-cell necrosis was 12 times the exposure in humans given 400 mg once daily.
U ženki miša, izloženost atazanaviru u dozi koja je izazvala nekrozu pojedinačnih stanica bila je 12 puta veća od izloženosti u ljudi koji su dobivali 400 mg jedanput na dan.
Co-administration of atazanavir with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate or norethindrone has not been studied, and therefore should be avoided (see section 4.5).
Nije ispitana istovremena primjena atazanavira i druge hormonske ili oralne kontracepcije koja sadrži progestagene, osim norgestimata ili noretindrona, te se stoga mora izbjegavati (vidjeti dio 4.5).