natgillin/translations-raw huggingface dataset:
Cobicistat is not expected to induce CYP3A4 or P-gp. 
Ne očekuje se da će kobicistat inducirati CYP3A4 ili P-gp.
In long-term carcinogenicity studies of atazanavir in mice and rats, an increased incidence of benign hepatic adenomas was seen in female mice only. 
U dugotrajnim ispitivanjima kancerogenosti atazanavira u miševa i štakora opažena je povećana incidencija benignih adenoma jetre, ali samo u ženki miša.
Atazanavir with cobicistat and emtricitabine and tenofovir DF fixed-dose combination was non-inferior in achieving HIV-1 RNA <50 copies/ml when compared to atazanavir with ritonavir and emtricitabine and tenofovir DF fixed-dose combination. 
Atazanavir s kobicistatom i kombinacijom fiksnih doza emtricitabina i tenofovira DF pokazao se neinferiornim u postizanju razine HIV-1 RNK od < 50 kopija/ml u usporedbi s atazanavirom s ritonavirom i kombinacijom fiksnih doza emtricitabina i tenofovira DF.
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). 
Jedna EVOTAZ tableta bioekvivalentna je jednoj kapsuli atazanavira (300 mg) plus jednoj tableti kobicistata (150 mg) primijenjenima peroralno u jednokratnoj dozi uz lagan obrok u zdravih ispitanika (n=62).
In rats, ossification changes in the spinal column and sternebra of foetuses occurred at a dose that produced significant maternal toxicity. 
Osifikacijske promjene na kralježnici i sternebri fetusa štakora pojavile su se pri dozi koja je uzrokovala značajnu toksičnost za majku.
The mechanism of interaction between atazanavir/ritonavir and sofosbuvir/velpatasvir/voxilaprevir is inhibition of OATP1B, Pgp, and CYP3A. 
Mehanizam interakcije između atazanavira/ritonavira i sofosbuvira/velpatasvira/voksilaprevira je inhibicija OATP1B, Pgp-a i CYP3A.
Higher plasma concentrations of coadministered medicinal products can result in increased or prolonged therapeutic effects or adverse reactions. 
Povišene plazmatske koncentracije istodobno primijenjenih lijekova mogu za posljedicu imati pojačane ili produljene terapijske učinke ili nuspojave.
Following oral administration of [14C]cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat. 
Nakon peroralne primjene [14C]kobicistata, 99% cirkulirajuće radioaktivnosti u plazmi činio je kobicistat u neizmijenjenom obliku.
Treatment difference -2.2% (95% CI = -7.4%, 3.0%) -2.1% (95% CI = -8.7%, 4.5%) Virologic failurec 
-2,2% (95% CI = -7,4%; 3,0%) -2,1% (95% CI = -8,7%; 4,5%)
They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system. 
Djeluju tako što smanjuju količinu HIV-a u tijelu, što jača imunosni sustav.
Co-administration with EVOTAZ can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.5). 
Istodobna primjena s lijekom EVOTAZ može povisiti plazmatske koncentracije lijekova koje metabolizira CYP2D6 (vidjeti dijelove 4.3 i 4.5).
Co-administration warrants clinical monitoring for sedation and cognitive effects. 
Istodobna primjena zahtijeva kliničko praćenje zbog moguće sedacije i kognitivnih učinaka.
Clinical monitoring is recommended when dabigatran is co-administered with P-gp inhibitors. 
Preporučuje se kliničko praćenje kada se dabigatran primjenjuje istodobno s inhibitorima P-gp-a.
When co-administering tenofovir alafenamide/emtricitabine and EVOTAZ, the recommended dose of tenofovir alafenamide/emtricitabine is 10/200 mg once daily. 
Pri istodobnoj primjeni tenofoviralafenamida/emtricitabina i lijeka EVOTAZ, preporučena doza tenofoviralafenamida/emtricitabina je 10/200 mg jedanput na dan.
EVOTAZ is to be taken orally with food (see section 5.2). 
EVOTAZ se uzima peroralno, s hranom (vidjeti dio 5.2).
There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat. 
Trenutno nema odgovarajućih podataka na temelju kojih bi se utvrdilo je li istodobna primjena tenofovirdizoproksila i kobicistata povezana s povećanim rizikom od bubrežnih nuspojava u usporedbi s režimima koji uključuju tenofovirdizoproksilbez kobicistata.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. 
Ako u tih bolesnika postoje dokazi pogoršanja bolesti jetre, mora se razmotriti privremen ili trajan prekid liječenja.
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. 
U ispitivanjima toksičnosti ponovljenih doza provedenih u miševa, štakora i pasa, nalazi povezani s atazanavirom općenito su bili ograničeni na jetru i obično su uključivali minimalna do blaga povišenja serumskog bilirubina i jetrenih enzima, hepatocelularnu vakuolizaciju i hipertrofiju te, samo u ženki miša, nekrozu pojedinačnih jetrenih stanica.
Given that cobicistat has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is co-administered with EVOTAZ. 
Budući da se pokazalo da kobicistat ne utječe značajno na koncentracije metadona, ne očekuje se interakcija pri istodobnoj primjeni metadona s lijekom EVOTAZ.
No significant effect on atazanavir concentrations was observed when administered with enteric-coated didanosine, but administration with food decreased didanosine concentrations. 
Nije opažen značajan učinak na koncentracije atazanavira kod primjene sa želučanootpornim kapsulama didanozina, ali je primjena s hranom snizila koncentracije didanozina.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza 'Rok valjanosti'.
Each bottle contains 30 film-coated tablets and a silica gel dessicant. 
Jedna boca sadrži 30 filmom obloženih tableta i silikagel kao sredstvo za sušenje.
Concentrations of ethinyl estradiol and norethindrone are increased when a combined oral contraceptive containing those agents is co-administered with atazanavir. 
Koncentracije etinilestradiola i noretindrona se povisuju kada se kombinirani oralni kontraceptiv koji sadrži te tvari primjenjuje istodobno s atazanavirom.
Atazanavir is a weak to moderate inhibitor of CYP2C8. 
Atazanavir je slab do umjeren inhibitor CYP2C8.
In the group receiving atazanavir 300 mg co-administered with ritonavir 100 mg, evaluable genotypic data was available for all 19 virologic failures (5%, 19/348). 
U skupini koja je primala atazanavir u dozi od 300 mg istodobno s ritonavirom u dozi od 100 mg, ocjenjivi genotipski podaci bili su dostupni za svih 19 slučajeva virološkog neuspjeha (5%, 19/348).
ANTIDIABETICS Metformin 
ANTIDIJABETICI Metformin
It is important to tell your doctor if you are taking: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. 
Važno je da obavijestite svog liječnika ako uzimate: Kortikosteroide koji uključuju betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon.
Cobicistat exposures are non-linear and greater than dose-proportional over the range of 50 mg to 400 mg, consistent with a mechanism-based CYP3A inhibitor. 
Izloženost kobicistatu je nelinearna i veća od one proporcionalne dozi u rasponu doza od 50 mg do 400 mg, što odgovara inhibitoru enzima CYP3A temeljeno na mehanizmu.
The activity of cobicistat as a pharmacokinetic enhancer to atazanavir has been demonstrated in pharmacokinetic trials. 
Aktivnost kobicistata kao farmakokinetičkog pojačivača atazanavira dokazana je u farmakokinetičkim ispitivanjima.
The potential for PR prolongation should be considered in cases of overdose (see section 4.9). 
U slučajevima predoziranja treba uzeti u obzir mogućnost produljenja PR-intervala (vidjeti dio 4.9).
Atazanavir exhibits anti-HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture. 
Atazanavir u staničnoj kulturi ima anti-HIV-1 (uključujući sve ispitane sojeve) i anti-HIV-2 aktivnost.
NEUROLEPTICS Perphenazine Risperidone Thioridazine 
NEUROLEPTICI Perfenazin Risperidon Tioridazin
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) 
Nenukleozidni inhibitori reverzne transkriptaze (NNRTI))
The recommendations shown in Table 1 are based on either drug interaction trials of unboosted atazanavir, atazanavir boosted with ritonavir, cobicistat or predicted interactions due to the expected magnitude of the interaction and potential for serious adverse reactions or loss of therapeutic effect of EVOTAZ. 
Preporuke prikazane u Tablici 1 temelje se ili na ispitivanjima interakcija nepojačanog atazanavira, atazanavira pojačanog ritonavirom i atazanavira pojačanog kobicistatom ili na interakcijama koje se predviđaju na temelju očekivane jačine interakcije i mogućnosti nastupa ozbiljnih nuspojava ili gubitka terapijskog učinka lijeka EVOTAZ.
Concentrations of ketoconazole, itraconazole, and/or cobicistat may be increased with co-administration of ketoconazole or itraconazole with EVOTAZ. 
Koncentracije ketokonazola, itrakonazola i/ili kobicistata mogu porasti kod istodobne primjene ketokonazola ili itrakonazola i lijeka EVOTAZ.
Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%). 
Ostala značajna klinička odstupanja u laboratorijskim nalazima (3. ili 4. stupnja) prijavljena u ≥ 2% bolesnika koji su primali režime s atazanavirom i jednim ili više NRTI-ja uključivali su: povišenu razinu kreatin kinaze (7%), povišenu alanin aminotransferazu/serumsku glutamat-piruvat transaminazu (ALT/SGPT) (5%), nizak broj neutrofila (5%), povišenu aspartat aminotransferazu/serumsku glutamat-oksaloacetat transaminazu (AST/SGOT) (3%) i povišenu razinu lipaze (3%).
Plasma levels of cobicistat and consequently of atazanavir may decrease significantly during pregnancy. 
Vrijednosti kobicistata i posljedično atazanavira u plazmi mogu značajno pasti tijekom trudnoće.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 
Prijavljeni su slučajevi osteonekroze, osobito u bolesnika s opće poznatim čimbenicima rizika, uznapredovalom HIV bolešću ili dugotrajnom izloženošću kombiniranoj antiretrovirusnoj terapiji.
When co-administering with EVOTAZ, titrate the digoxin dose and monitor digoxin concentrations. 
Kod istodobne primjene s lijekom EVOTAZ, potrebno je titrirati dozu digoksina i kontrolirati njegove koncentracije.
When co-administering maraviroc and EVOTAZ, patients should receive maraviroc 150 mg twice daily. 
Kada se maravirok primjenjuje istodobno s lijekom EVOTAZ, bolesnici trebaju primati 150 mg maraviroka dvaput na dan.
There is a risk of loss of therapeutic effect and development of resistance to atazanavir (see section 4.3). 
Postoji rizik od gubitka terapijskog učinka i razvoja rezistencije na atazanavir (vidjeti dio 4.3).
Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended (see section 4.3). 
Preporučuje se primjena drugih antitrombotika na koje ne utječu inhibicija ili indukcija CYP enzima (npr. prasugrel) (vidjeti dio 4.3).
Since atazanavir and cobicistat are extensively metabolised by the liver and highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicinal product. 
Budući da se atazanavir i kobicistat opsežno metaboliziraju u jetri i u visokoj mjeri vežu za proteine u plazmi, nije vjerojatno da će dijaliza biti korisna za uklanjanje ovog lijeka u znatnijoj mjeri.
Cmax: ↑41% Cmin: not determined 
AUC: ↔ Cmax: ↑41% Cmin: nije određen
EVOTAZ should not be co-administered with triazolam or orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of EVOTAZ and parenteral midazolam. 
EVOTAZ se ne smije primjenjivati istodobno s triazolamom ili peroralno primijenjenim midazolamom (vidjeti dio 4.3), dok je kod istodobne primjene lijeka EVOTAZ i parenteralnog midazolama potreban oprez.
ANTIPSYCHOTICS Pimozide 
ANTIPSIHOTICI Pimozid
Amiodarone, dronedarone, quinidine and systemic lidocaine have a narrow therapeutic window and are contraindicated due to potential inhibition of CYP3A by EVOTAZ (see section 4.3). 
Amiodaron, dronedaron, kinidin i sistemski lidokain imaju uzak terapijski raspon te je njihova primjena kontraindicirana zbog moguće inhibicije CYP3A koju uzrokuje EVOTAZ (vidjeti dio 4.3).
Pink, oval, biconvex, film-coated tablet of approximate dimensions of 19 mm x 10.4 mm, debossed with "3641" on one side and plain on the other side. 
Ružičasta, ovalna, bikonveksna, filmom obložena tableta dimenzija približno 19 mm x 10,4 mm, s utisnutom oznakom "3641" na jednoj strani i bez oznake na drugoj strani.
Effect on atazanavir and ritonavir exposure has not been studied. 
Učinak na izloženost atazanaviru i ritonvairu nije ispitivan.
For further details, consult the Summary of Product Characteristics for maraviroc. 
Za više informacija pročitajte Sažetak opisa svojstava lijeka za maravirok.
Among the 21 subjects, 3 developed the emtricitabine-associated resistance substitution M184V. 
Među tih 21 ispitanika, u njih 3 se razvila supstitucija M184V povezana s rezistencijom na emtricitabin.
Subjects with significant liver function test abnormalities generally had abnormal baseline transaminases (AST or ALT), underlying chronic or acute hepatitis B or C co-infection, concomitant hepatotoxic medications (e.g., isoniazid), or a medical history of alcoholism or alcohol abuse. 
Ispitanici sa značajnim odstupanjima u nalazima testova jetrene funkcije u načelu su imali abnormalne početne razine transaminaza (AST-a ili ALT-a), podležeću kroničnu ili akutnu istodobnu infekciju hepatitisom B ili C, istodobno su uzimali hepatotoksične ljekove (npr. izoniazid) ili su u anamnezi imali alkoholizam ili prekomjerno uživanje alkohola.
The overall safety profile of EVOTAZ is based on available data from clinical trials conducted with atazanavir, atazanavir boosted with either cobicistat or ritonavir, and post-marketing data. 
Ukupan profil sigurnosti lijeka EVOTAZ temelji se na dostupnim podacima iz kliničkih ispitivanja provedenih s atazanavirom i atazanavirom pojačanim kobicistatom ili ritonavirom te podacima prikupljenima nakon stavljanja lijeka u promet.
Following a single 400 mg dose of [14C]atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively. 
Nakon jednokratne doze od 400 mg [14C]atazanavira, 79% ukupne radioaktivnosti pronađeno je u fecesu, a 13% u mokraći.
Concomitant administration of boceprevir and atazanavir/ritonavir resulted in reduced exposures to atazanavir and ritonavir. 
Istodobna primjena boceprevira i atazanavira/ritonavira smanjila je izloženost atazanaviru i ritonaviru.
Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4. 
Kao i ketokonazol, itrakonazol je snažan inhibitor, ali i supstrat za CYP3A4.
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). 
Kod lijekova koji se metaboliziraju putem CYP3A te povišene plazmatske koncentracije mogu uzrokovati teške, po život opasne ili smrtonosne događaje (vidjeti dijelove 4.3 i 4.5).
Disopyramide Flecainide Mexiletine Propafenone 
Dizopiramid Flekainid Meksiletin Propafenon
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.
EVOTAZ should not be used in combination with ritonavir or medicinal products containing ritonavir due to similar pharmacological effects of cobicistat and ritonavir on CYP3A (see section 4.5). 
EVOTAZ se ne smije primjenjivati u kombinaciji s ritonavirom ni lijekovima koji sadrže ritonavir jer kobicistat i ritonavir imaju slične farmakološke učinke na CYP3A (vidjeti dio 4.5).
Maraviroc is not expected to have an impact on concentrations of atazanavir and cobicistat. 
Ne očekuje se da će maravirok utjecati na koncentracije atazanavira i kobicistata.
Effects of co-administration of EVOTAZ on progestin and estrogen are unknown. 
Učinci istodobne primjene lijeka EVOTAZ na progestin i estrogen nisu poznati.
However, a higher percentage of subjects in the atazanavir boosted with cobicistat group had increases in total bilirubin > 2 x ULN than those in the atazanavir boosted with ritonavir group (88.0% versus 80.9%). 
Međutim, povećanja ukupnog bilirubina > 2 x GGN imao je veći postotak ispitanika u skupini koja je primala atazanavir pojačan kobicistatom nego onih u skupini koja je primala atazanavir pojačan ritonavirom (88,0% naspram 80,9%).
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the co-administered medicinal products (see section 4.4). 
Istodobna primjena lijeka EVOTAZ u bolesnika koji primaju lijekove koji su supstrati za prijenosnike P-gp, BCRP, MATE1, OATP1B1 i OATP1B3 može povisiti plazmatske koncentracije tih istodobno primijenjenih lijekova (vidjeti dio 4.4.)
General disorders and administration site conditions common fatigue uncommon pyrexia, asthenia, chest pain, malaise rare gait disturbance a These adverse reactions were identified through post-marketing surveillance; however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir (with and without ritonavir) in randomised controlled and other available clinical trials (n = 2321). 
manje često pireksija, astenija, bolovi u prsištu, malaksalost rijeko poremećaj hoda a Ove su nuspojave identificirane tijekom praćenja nakon stavljanja lijeka u promet; međutim, učestalost je procijenjena statističkim izračunom na temelju ukupnog broja bolesnika izloženih atazanaviru (u kombinaciji s ritonavirom ili bez njega) u randomiziranim kontroliranim i drugim dostupnim kliničkim ispitivanjima (n = 2321).
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. 
Atazanavir pokazuje nelineanu farmakokinetiku s povećanjima vrijednosti AUC-a i Cmax koja su veća od onih proporcionalnih dozi u rasponu doza od 200 mg do 800 mg jedanput na dan.
The rates of study drug discontinuation due to bilirubin-related adverse events were low and similar in both groups (4.9% in the cobicistat-boosted group and 4.0% in the ritonavir-boosted group). 
Stope prekida primjene ispitivanog lijeka zbog nuspojava povezanih s bilirubinom bile su niske i slične u obje skupine (4,9% u skupini koja je primala atazanavir pojačan kobicistatom i 4,0% u skupini koja je primal atazanavir pojačan ritonavirom).
As atazanavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2). 
Budući da se atazanavir i kobicistat u velikoj mjeri vežu za proteine u plazmi, malo je vjerojatno da će se značajno ukloniti iz tijela hemodijalizom ili peritonejskom dijalizom (vidjeti dijelove 4.2 i 5.2).
Steady-state cobicistat Cmax, AUCtau and Ctau (mean ± SD) values were 1.5 ± 0.5 μg/ml, 11.1 ± 4.5 μg•hr/ml and 0.05 ± 0.07 μg/ml, respectively (n=22). 
Vrijednost Cmax, AUCtau i Ctau (srednja vrijednost ± SD) kobicistata u stanju dinamičke ravnoteže iznosila je 1,5 ± 0,5 μg/ml, 11,1 ± 4,5 μg•hr/ml odnosno 0,05 ± 0,07 μg/ml (n=22).
Table 3: Virologic outcome of randomised treatment of study GS-US-216-0114 at weeks 48a and 144b 
Tablica 3: Virološki ishod randomiziranog liječenja u u 48.a i 144.b tjednu ispitivanja
Caution is also required during the first time of treatment if switching the pharmacoenhancer from ritonavir to cobicistat (see section 4.4). 
Oprez se preporučuje i tijekom prve primjene ako se prelazi s ritonavira kao farmakokinetičkog pojačivača na kobicistat (vidjeti dio 4.4).
Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of EVOTAZ with sildenafil. 
Vidjeti i dio 'PLUĆNA ARTERIJSKA HIPERTENZIJA' u ovoj tablici za dodatne informacije o istodobnoj primjeni lijeka EVOTAZ i sildenafila.
Atazanavir and fluconazole concentrations were not significantly modified when atazanavir/ritonavir was co-administered with fluconazole. 
Koncentracije atazanavira i flukonazola nisu se značajno promijenile kada se atazanavir/ritonavir primjenjivao istodobno s flukonazolom.
Eye disorders very common ocular icterus 
Poremećaji oka vrlo često očni ikterus
The studies presented in Table 1 were conducted in healthy subjects unless otherwise noted. 
Ako nije drugačije naznačeno, ispitivanja prikazana u Tablici 1 provedena su u zdravih ispitanika.
Clinical and laboratory monitoring for hyperbilirubinaemia is recommended. 
Preporučuje se kliničko i laboratorijsko praćenje na pojavu hiperbilirubinemije.
Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors. 
Maravirok je supstrat za CYP3A i njegove se plazmatske koncentracije povisuju pri istodobnoj primjeni sa snažnim inhibitorima CYP3A.
Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3). 
Osobit je oprez potreban kad se EVOTAZ propisuje zajedno s drugim lijekovima koji mogu produljiti QT-interval i/ili bolesnicima s već prisutnim čimbenicima rizika (bradikardija, kongenitalno produljen QT-interval, poremećaji elektrolita (vidjeti dijelove 4.8 i 5.3).
Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.8). 
Redovito praćenje bubrežne funkcije u bolesnika treba se održavati tijekom cijelog trajanja liječenja (vidjeti dio 4.8).
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
Ažurirani RMP treba dostaviti: na zahtjev Europske agencije za lijekove; prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjenarezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
There is no specific antidote for overdose with EVOTAZ. 
Ne postoji specifičan protulijek za predoziranje lijekom EVOTAZ.
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with EVOTAZ. 
Snižene plazmatske koncentracije atazanavira mogu biti posljedica povišenog želučanog pH ako se antacidi, uključujući puferirane lijekove, primjenjuju s lijekom EVOTAZ.
In a nonclinical fertility and early embryonic development study in rats, atazanavir altered oestrus cycling with no effects on mating or fertility (see section 5.3). 
U nekliničkom ispitivanju plodnosti i ranog embrionalnog razvoja u štakora, atazanavir je promijenio estrusne cikluse, ali nije utjecao na parenje ni plodnost (vidjeti dio 5.3).