natgillin/translations-raw huggingface dataset:
* In a combined analysis from several clinical studies, atazanavir/ritonavir 300/100 mg coadministered with tenofovir disoproxil fumarate 300 mg (n=39) was compared to atazanavir/ritonavir 300/100 mg (n=33).
* U kombiniranoj analizi nekoliko kliničkih ispitivanja, atazanavir/ritonavir 300/100 mg primijenjeni istovremeno s tenofovirdizoproksilfumaratom 300 mg (n=39) uspoređivani su s atazanavirom/ritonavirom 300/100 mg (n=33).
The geometric mean (CV%) for atazanavir Cmin and AUC were 120 (109) ng/ml and 14874 (91) ng•h/ml, respectively.
Geometrijska srednja vrijednost (CV%) Cmin atazanavira iznosila je 120 (109) ng/ml, a AUC atazanavira 14874 (91) ng•h/ml.
Atazanavir, the active substance of Atazanavir Mylan, is excreted in human milk.
Atazanavir, djelatna tvar lijeka Atazanavir Mylan izlučuje se u majčino mlijeko.
There were fewer treatment discontinuations in the unboosted atazanavir group (1 vs. 4 subjects in the atazanavir + ritonavir group).
Zabilježen je manji broj prekida liječenja u skupini liječenoj nepojačanim atazanavirom (1 naspram 4 ispitanika u skupini koja je primala atazanavir + ritonavir).
Co-administration with products containing St. John's wort (Hypericum perforatum) (see section 4.5).
Istovremena primjena s lijekovima koji sadrže gospinu travu (Hypericum perforatum) (vidjeti dio 4.5).
In an open-label, randomised, comparative study following a 26- to 30-week induction phase with atazanavir 300 mg + ritonavir 100 mg once daily and two NRTIs, unboosted atazanavir 400 mg once daily and two NRTIs administered during a 48-week maintenance phase (n=87) had similar antiviral efficacy compared with atazanavir + ritonavir and two NRTIs (n=85) in HIV infected subjects with fully suppressed HIV replication, as assessed by the proportion of subjects with HIV RNA < 50 copies/ml: 78% of subjects on unboosted atazanavir and two NRTIs compared with 75% on atazanavir + ritonavir and two NRTIs.
U otvorenom, randomiziranom, usporednom ispitivanju provedenom nakon 26 do 30 tjednog uvodnog liječenja atazanavirom u dozi od 300 mg + ritonavirom u dozi od 100 mg jedanput na dan i dvama NRTI-ma u ispitanika s HIV infekcijom i potpuno suprimiranom replikacijom HIV-a, kombinacija nepojačanog atazanavira u dozi od 400 mg jedanput na dan i dvaju NRTI-ja tijekom 48-tjedne faze održavanja (n=87) postigla je sličnu antivirusnu djelotvornost kao i atazanavir + ritonavir i dva NRTI-ja (n=85), što je utvrđeno na temelju udjela ispitanika s HIV RNK < 50 kopija/ml: 78% ispitanika liječenih nepojačanim atazanavirom i dvama NRTI-ma u usporedbi sa 75% ispitanika liječenih atazanavirom s ritonavirom i dvama NRTI-ma.
Your doctor should do blood tests prior you starting to take this medicine and during treatment.
Vaš liječnik treba napraviti krvne pretrage prije početka liječenja lijekom Atazanavir Mylan i tijekom liječenja.
• pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence
• pankreatitis (upala gušterače), gastritis (upala želuca), aftozni stomatitis (ranice u ustima i groznica na usnama), disgeuzija (promjene osjeta okusa), flatulencija (vjetrovi), suha usta,
At baseline, 34% of patients were receiving a PI and 60% were receiving an NNRTI.
Na početku je 34% bolesnika primalo inhibitor proteaze, a 60% je primalo neki NNRTI.
Three of 20 infants (15%) born to women treated with atazanavir/ritonavir 300/100 mg and four of 20 infants (20%) born to women treated with atazanavir/ritonavir 400/100 mg experienced grade 3-4 bilirubin.
Troje od 20 dojenčadi (15%) žena liječenih s atazanavirom/ritonavirom 300/100 mg i četvero od 20 dojenčadi (20%) žena liječenih s atazanavirom/ritonavirom 400/100 mg imalo je bilirubin 3.-4. stupnja.
The most frequently reported laboratory abnormality in paediatric patients receiving atazanavir was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4) which occurred in 45% of patients.
Najčešće zabilježeni poremećaj laboratorijskih nalaza u pedijatrijskih bolesnika koji su primali atazanavir bilo je povišenje ukupnog bilirubina (≥ 2,6 puta iznad gornje granice normale, 3.-4. stupanj), koje je nastalo u 45% bolesnika.
HIV RNA Mean Change from Baseline, log10 copies/ml All patients
HIV RNK prosječna promjena od početne vrijednosti, log10 kopija/ml Svi bolesnici
• If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to atazanavir 400 mg with ritonavir 100 mg with TDM may be considered (see sections 4.6 and 5.2).
• Ako je potrebno primijeniti tenofovirdizoproksil ili antagonist H2-receptora, možda će trebati razmotriti povećanje doze atazanavira na 400 mg primijenjeno s ritonavirom od 100 mg uz praćenje koncentracije lijeka (vidjeti dijelove 4.6 i 5.2).
Among patients who received atazanavir 400 mg once daily or atazanavir 300 mg with ritonavir 100 mg once daily, the only adverse reactions of any severity reported very commonly with at least a possible relationship to regimens containing atazanavir and one or more NRTIs were nausea (20%), diarrhoea (10%), and jaundice (13%).
Među bolesnicima koji su primali atazanavir 400 mg jedanput na dan ili atazanavir 300 mg s ritonavirom 100 mg jedanput na dan, jedine vrlo često zabilježene nuspojave bilo koje težine s barem mogućom povezanošću s protokolima koji sadrže atazanavir i jedan ili više NRTI-jeva bile su mučnina (20%), proljev (10%) i žutica (13%).
Co-administration of atazanavir with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations associated with increased grazoprevir concentrations (see section 4.3).
Istodobna primjena atazanavira s lijekovima koji sadrže grazoprevir, uključujući fiksnu dozu kombinacije elbasvira/grazoprevira (koja se koristi u liječenju kronične infekcije virusom hepatitisa C) kontraindicirana je zbog povišene koncentracije grazoprevira i elbasvira u plazmi te postoji rizik povišenja vrijednosti ALT-a zbog povećane koncentracije grazoprevira (vidjeti dio 4.3).
Frequency de novo PI substitution (n=26)
Učestalost de novo supstitucija za rezistenciju na inhibitor proteaze (n=26)
Ethinyloestradiol Cmax ↑15% (↓1%
Etinilestradiol Cmax ↑15% (↓1%
No significant effect on atazanavir concentrations was observed.
Nisu opaženi značajni učinci na koncentracije atazanavira.
25-O-desacetyl-rifabutin AUC
25-O-dezacetil -rifabutin Cmin
Adverse reactions were consistent between patients who received atazanavir 400 mg once daily and patients who received atazanavir 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with atazanavir plus ritonavir.
Nuspojave u bolesnika koji su primali atazanavir 400 mg jedanput na dan bile su sukladne nuspojavama u bolesnika koji su primali atazanavir 300 mg s ritonavirom 100 mg jedanput na dan, osim što su žutica i povišene razine ukupnog bilirubina bile zabilježene češće uz atazanavir s ritonavirom.
Voriconazole Cmax ↑438% (↑355%
Vorikonazol Cmax ↑438% (↑355%
Asymptomatic first- and second-degree AV block was reported in paediatric patients (see section 4.8).
U pedijatrijskih je bolesnika bio zabilježen asimptomatski AV blok prvog i drugog stupnja (vidjeti dio 4.8).
Co-administration with atazanavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-inhibitor-associated adverse events.
Istovremena primjena s atazanavirom može rezultirati povišenim koncentracijama inhibitora PDE5 i pojačanim nuspojavama povezanima s inhibitorom PDE5.
HDPE bottle with polypropylene screw cap containing 30, 90 capsules.
Boca od polietilena visoke gustoće (HDPE) s navojnim čepom od polipropilena koja sadrži 30, 90 kapsula.
Norgestimate AUC ↑85% (↑67%
Norgestimat AUC ↑85% (↑67%
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by atazanavir.
Kinidin ima uzak terapijski raspon i kontraindiciran je zbog moguće inhibicije enzima CYP3A atazanavirom.
HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Gospina trava (Hypericum perforatum)
Talk to your doctor immediately if you get dark (tea-colored) urine, itching, yellowing of your skin or the white part of your eyes, pain around the stomach, pale colored stools or nausea.
Odmah se obratite liječniku ako Vaša mokraća postane tamnija (boje poput čaja), ako se razviju svrbež, žutilo kože ili bjeloočnica, bol u trbuhu, blijeda stolica ili mučnina.
Sildenafil, tadalafil, and vardenafil are metabolised by CYP3A4.
Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil i vardenafil metabolizira enzim CYP3A4.
Norethindrone Cmin ↑262% (↑157%
Noretindron Cmin ↑262% (↑157%
uncommon: hypersensitivity
manje često: preosjetljivost
LIPID LOWERING AGENTS HMG- CoA reductase inhibitors Simvastatin
Inhibitori reduktaze HMG-CoA Simvastatin
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Nakon što počnete s liječenjem Vaše HIV infekcije, osim oportunističkih infekcija, mogu se pojaviti autoimune bolesti (stanje koje nastaje kad imunološki sustav napada zdrava tjelesna tkiva).
The M184I/V substitution emerged in 5/26 Atazanavir /ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Supstitucija M184I/V bila je prisutna u 5 od 26 bolesnika u kojih liječenje atazanavirom s ritonavirom nije bilo virološki uspješno i 7 od 26 bolesnika u kojih liječenje lopinavirom/ritonavirom nije bilo virološki uspješno.
If signs or symptoms of cholelithiasis occur, temporary interruption or discontinuation of treatment may be considered.
Ako se pojave znakovi i simptomi kolelitijaze, može se razmotriti privremeni ili trajni prekid liječenja.
The mean baseline CD4 cell count was 337 cells/mm
Prosječni početni broj CD4 stanica iznosio je 337 stanica/mm
HDPE bottle with polypropylene screw cap containing 60 capsules.
Boca od polietilena visoke gustoće (HDPE) s navojnim čepom od polipropilena koja sadrži 60 kapsula.
Co-administration of simvastatin or lovastatin with atazanavir is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Kontraindicirana je istovremena primjena simvastatina ili lovastatina s atazanavirom zbog povišenog rizika od miopatije uključujući rabdomiolizu (vidjeti dio 4.3).
Therapy should be initiated by a physician experienced in the management of HIV infection.
4.2 Doziranje i način primjene Terapiju treba započeti liječnik s iskustvom u liječenju HIV-infekcije.
Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with atazanavir may result in increased concentrations.
Metabolizam simvastatina i lovastatina jako ovisi o enzimu CYP3A4 i istovremena primjena s atazanavirom može rezultirati povišenim koncentracijama.
Six of 20 (30%) women on atazanavir/ritonavir 300/100 mg and 13 of 21 (62%) women on atazanavir /ritonavir 400/100 mg experienced grades 3 to 4 hyperbilirubinaemia.
Šest od 20 (30%) žena koje su primale atazanavir/ritonavir 300/100 mg i 13 od 21 (62%) žene koje su primale atazanavir/ritonavir 400/100 mg razvilo je hiperbilirubinemiju 3. do 4. stupnja.
In the majority of patients with at least one functional CYP2C19 allele, a reduction in both voriconazole and atazanavir exposures are expected.
U većine bolesnika s najmanje jednim funkcionalnim CYP2C19 alelom očekuje se smanjenje izloženosti kako vorikonazolu tako i atazanaviru.
Co-administration of Atazanavir Mylan with these medicinal products is expected to substantially increase their concentrations and may result in PDE5-associated adverse reactions such as hypotension, visual changes and priapism (see section 4.5).
Pri istovremenoj primjeni lijeka Atazanavir Mylan i ovih lijekova očekuje se znatno povećanje njihove koncentracije, što može rezultirati nuspojavama povezanima s PDE5, kao što su hipotenzija, poremećaji vida i prijapizam (vidjeti dio 4.5).
30 hard capsules 60 hard capsules.
30 hard capsules 60 tvrdih kapsula.
When atazanavir and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
Kod istovremene primjene atazanavira i ritonavira može prevladavati metabolički profil interakcija za ritonavir, zato što je ritonavir jači inhibitor enzima CYP3A4 od atazanavira.
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.
Među prethodno liječenim bolesnicima koji su primali atazanavir 300 mg jedanput na dan sa 100 mg ritonavira jedanput na dan tijekom srednjeg razdoblja od 95 tjedana, 53% imalo je povišenje ukupnog bilirubina 3.-4. stupnja.
Concomitant use of Atazanavir Mylan/ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Ne preporučuje se istovremena primjena lijeka Atazanavir Mylan s ritonavirom i flutikazona ili drugih kortikosteroida koje metabolizira enzim CYP3A4, osim ako je moguća korist liječenja veća od rizika od učinaka sistemskih kortikosteroida, uključujući Cushingov sindrom i supresiju nadbubrežne žlijezde (vidjeti dio 4.5).
Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Istovremena primjena s lijekovima koji su supstrati izoenzima CYP3A4 citokroma P450 i imaju uzak terapijski raspon (npr. kvetiapin, lurasidon, alfuzozin, astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralno primijenjen midazolam (za mjere opreza kod parenteralno primijenjenog midazolama, vidjeti dio 4.5) i alkaloidi ergota, osobito ergotamin, dihidroergotamin, ergonovin, metilergonovin) (vidjeti dio 4.5).
Didanosine Cmin ↑25% (↓8% ↑69%)
Didanozin Cmin ↑25% (↓8% ↑69%)
Voriconazole AUC ↑561% (↑451%
Vorikonazol AUC ↑561% (↑451%
If the combination of Atazanavir Mylan with a proton pump inhibitor 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.
Ako se prosudi da je kombinacija lijeka Atazanavir Mylan s inhibitorom protonske pumpe neizbježna, preporučuje se pažljiv klinički nadzor u kombinaciji s povišenjem doze atazanavira na 400 mg uz 100 mg ritonavira; ne smije se prekoračiti doza inhibitora protonske pumpe koja je usporediva s dozom omeprazola od 20 mg.
, angioedema a, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndrome a,b
pruritus; rijetko: Stevens-Johnsonov sindrom a,b
An initial dose reduction of diltiazem by 50% is recommended, with subsequent
Preporučuje se smanjenje početne doze diltiazema za 50%, uz kasniju titraciju po potrebi i elektrokardiografski nadzor.
Patients should be informed that dizziness has been reported during treatment with regimens containing atazanavir (see section 4.8).
Bolesnike treba obavijestiti da je tijekom liječenja protokolima koji sadrže atazanavir zabilježena omaglica (vidjeti dio 4.8).
This decrease in atazanavir Cmin, might negatively impact the efficacy of atazanavir.
Ovo sniženje Cmin atazanavira može negativno utjecati na djelotvornost atazanavira.
What Atazanavir Mylan contains
Što Atazanavir Mylan sadrži
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA <400 copies/ml (<50 copies/ml) for atazanavir + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).
Analizom prema liječenju, isključujući vrijednosti koje su nedostajale, udio bolesnika s HIV RNK <400 kopija/ml (<50 kopija/ml) u skupini koja je primala atazanavir s ritonavirom iznosio je 84% (72%), a u skupini koja je primala lopinavir s ritonavirom 82% (72%).
Unboosted atazanavir must not be used in patients with severe hepatic impairment.
Nepojačani atazanavir ne smije se primjenjivati u bolesnika s teškim oštećenjem funkcije jetre.
In HIV-infected adult patients (n=33, combined studies) the mean half-life within a dosing interval for atazanavir was 12 hours at steady state following a dose of 300 mg daily with ritonavir 100 mg once daily with a light meal.
U odraslih bolesnika zaraženih HIV-om (n=33, kombinirana ispitivanja), prosječni poluvijek unutar intervala doziranja atazanavira iznosio je 12 sati u stanju dinamičke ravnoteže nakon doze od 300 mg na dan zajedno s ritonavirom u dozi od 100 mg jedanput na dan, uz lagani obrok.
Ethinyloestradiol Cmin ↑91% (↑57%
Etinilestradiol Cmin ↑91% (↑57%
EU/1/16/1091/001 EU/1/16/1091/002 EU/1/16/1091/003 EU/1/16/1091/004 EU/1/16/1091/005 EU/1/16/1091/006 EU/1/16/1091/007 EU/1/16/1091/008 EU/1/16/1091/009 EU/1/16/1091/010 EU/1/16/1091/011 EU/1/16/1091/012 EU/1/16/1091/013 EU/1/16/1091/014 EU/1/16/1091/015 EU/1/16/1091/016 EU/1/16/1091/017
EU/1/16/1091/001 EU/1/16/1091/002 EU/1/16/1091/003 EU/1/16/1091/004 EU/1/16/1091/005 EU/1/16/1091/006 EU/1/16/1091/007 EU/1/16/1091/008 EU/1/16/1091/009 EU/1/16/1091/010 EU/1/16/1091/011 EU/1/16/1091/012 EU/1/16/1091/013 EU/1/16/1091/014 EU/1/16/1091/015 EU/1/16/1091/016
Didanosine (enteric coated capsules) 400 mg single dose
Didanozin (želučanootporne kapsule) 400 mg, jednokratna doza
No significant effect on didanosine and stavudine concentrations was observed.
Nije opažen značajan učinak na koncentracije didanozina i stavudina.
Geometric mean (CV%) AUC ng•h/mL
Geometrijska sredina (CV%) AUC ng•h/mL Geometrijska sredina (CV%) Cmin ng/mL
All patients HIV RNA <400 copies/ml, %
Svi bolesnici HIV RNK <400 kopija/ml, %
• asthenia (unusual tiredness or weakness)
• astenija (neobičan umor ili slabost)
Norethindrone Cmax ↑67% (↑42%
Noretindron Cmax ↑67% (↑42%
Co-administration of Atazanavir Mylan and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Ne preporučuje se istovremena primjena lijeka Atazanavir Mylan i lijekova koji induciraju CYP3A4 (vidjeti dijelove 4.3 i 4.5).
No drug interaction study has been performed for the co-administration of atazanavir with benzodiazepines.
Nisu provedena ispitivanja interakcija lijekova kod istovremene primjene atazanavira i benzodiazepina.
Titanium dioxide (E171) Indigo Carmine (E132) Gelatin
Titanijev dioksid (E171) Indigo karmin (E132) Želatina
Voriconazole Cmin ↑765% (↑571%
Vorikonazol Cmin ↑765% (↑571%
14-OH clarithromycin Cmin ↓62%
14-OH klaritromicin Cmin ↓62%
14-OH clarithromycin Cmax ↓72%
14-OH klaritromicin Cmax ↓72%
36 (43/120) 32 (38/120) 42 (52/123)_ 35 (41/118) NA
(bolesnici s odgovorom/bolesnici koji su se mogli procijeniti) Svi bolesnici 36 (43/120) 32 (38/120) 42 (52/123 35 (41/118) NP
In a small number of patients without a functional CYP2C19 allele, significantly increased voriconazole exposures are expected.
U malog broja bolesnika bez funkcionalnog CYP2C19 alela očekuje se značajno povećanje izloženosti vorikonazolu.
The concomitant use of quinidine is contraindicated (see section 4.3).
Istovremena primjena kinidina je kontraindicirana (vidjeti dio 4.3).
Both asymptomatic first-degree (23%) and second-degree (1%) atrioventricular block were reported in paediatric patients.
U pedijatrijskih je bolesnika bio zabilježen i asimptomatski atrioventrikularni blok prvog (23%) ili drugog stupnja (1%).
Propylene glycol Ammonia solution, concentrated Iron oxide black (E172) Potassium hydroxide
Otopina amonijaka, koncentrirana Crni željezov oksid (E172) Kalijev hidroksid
Atazanavir + saquinavir was shown to be inferior to lopinavir + ritonavir.
Pokazalo se da je atazanavir sa sakvinavirom inferioran kombinaciji lopinavira s ritonavirom.
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2-blockers.
Mehanizam interakcije je smanjenje topljivosti atazanavira s povećanjem želučanog pH zbog H2 blokatora.
Tell your doctor if you notice anything unusual about your health.
Ako primijetite nešto neobično u vezi sa svojim zdravljem, obavijestite o tome
(range: 100 to 1157 cells/ mm 3) and mean baseline plasma HIV 1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
(raspon: 100 do 1157 stanica/ mm 3), a prosječna početna vrijednost HIV 1 RNK u plazmi iznosila je 4,09 log10 kopija/ml (raspon: 3,28 do 5,00 log10 kopija/ml).
3rd Trimester (n=20)
3. tromjesečje (n=20)
When co-administered with tenofovir disoproxil fumarate, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg and tenofovir disoproxil fumarate 300 mg (all as a single dose with food).
Kada se atazanavir primjenjuje istovremeno s tenofovirdizoproksilfumaratom, preporučuje se primijeniti 300 mg atanazavira sa 100 mg ritonavira i 300 mg tenofovirdizoproksilfumarata (svi se primjenjuju kao jednokratna doza s hranom).
Atazanavir Mylan contains lactose
Atazanavir Mylan sadrži laktozu
Among naive 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).
Među bolesnicima koji prethodno nisu bili liječeni i primali su atazanavir 300 mg jedanput na dan sa 100 mg ritonavira jedanput na dan tijekom srednjeg razdoblja od 96 tjedana, 48% imalo je povišenje ukupnog bilirubina 3.-4. stupnja (vidjeti dio 4.4).
- in patients without a functional CYP2C19 allele, close clinical and laboratory monitoring of voriconazole-associated adverse events is recommended
- za bolesnike bez funkcionalnog CYP2C19 alela preporučuje se poman nadzor kliničkih i laboratorijskih parametara koji upućuju na nuspojave povezane s vorikonazolom
postpartum a
Nakon porođaja a
The pharmacokinetics of atazanavir exhibit a non-linear disposition.
Farmakokinetika atazanavira pokazuje nelinearni oblik.
* When compared to atazanavir 300 mg and ritonavir 100 mg without nevirapine.
* Kad se uspoređivao s atazanavirom 300 mg i ritonavirom 100 mg bez nevirapina.
(atazanavir 400 mg single dose)
(atazanavir 400 mg, jednokratna doza)
Frequency de novo PI substitution (n=35)
Učestalost de novo supstitucije za rezistenciju na inhibitor proteaze (n=35)
Concentrations of these immunosuppressants may be increased when co-administered with atazanavir due to CYP3A4 inhibition.
Koncentracije ovih imunosupresiva mogu biti povišene kad se primjenjuju istovremeno s atazanavirom zbog inhibicije CYP3A4.
a none none a
a nijedna 10-20% nijedna a
Norethindrone AUC ↑110% (↑68%
Noretindron AUC ↑110% (↑68%
In HIV-infected patients (n=33, combined studies), multiple dosing of atazanavir 300 mg once daily with ritonavir 100 mg once daily with food produced a geometric mean (CV%) for atazanavir, Cmax of 4466 (42%) ng/ml, with time to Cmax of approximately 2.5 hours.
U bolesnika zaraženih HIV-om (n=33, kombinirana ispitivanja), višestruka primjena atazanavira 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan s hranom dovela je do geometrijske sredine (CV%) Cmax atazanavira od 4466 (42%) ng/ml, uz vrijeme do postizanja Cmax od približno 2,5 sati.
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA < 400 copies/ml (< 50 copies/ml) in the atazanavir + ritonavir arm and the lopinavir + ritonavir arm were 55% (40%) and 56% (46%), respectively.
Analizom prema liječenju, isključujući vrijednosti koje su nedostajale, udio bolesnika s HIV RNK < 400 kopija/ml (< 50 kopija/ml) u skupini koja je primala atazanavir s ritonavirom iznosio je 55% (40%), a u skupini koja je primala lopinavir s ritonavirom 56% (46%).