FrancophonIA/ELRC3.0 huggingface dataset:
English: If the co-administration of Atazanavir Krka with an NNRTI is required, an increase in the dose of both Atazanavir Krka and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
Croatian: Ako je potrebno istovremeno primjenjivati Atazanavir Krka s nekim NNRTI-jem, može se razmotriti povišenje doze lijeka Atazanavir Krka na 400 mg i ritonavira na 200 mg u kombinaciji s efavirenzom, uz pažljivo praćenje bolesnika.
English: common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitis a
Croatian: često: žutica; manje često: hepatitis, kolelitijaza a, kolestaza a;
English: Paediatric patients (less than 3 months of age) Atazanavir Krka should not be used in children less than 3 months because of safety concerns especially taking into account the potential risk of kernicterus.
Croatian: Krka se ne smije primjenjivati u djece mlađe od 3 mjeseca zbog sigurnosnih razloga, osobito kada se uzme u obzir mogući rizik od kernikterusa.
English: Atazanavir has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving atazanavir 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or atazanavir 300 mg with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration).
Croatian: Sigurnost atazanavira procijenjena je u kombiniranoj terapiji s drugim antiretrovirusnim lijekovima u kontroliranim kliničkim ispitivanjima u 1806 odraslih bolesnika koji su primali atazanavir 400 mg jedanput na dan (1151 bolesnika, srednje trajanje liječenja 52 tjedna i maksimalno trajanje liječenja
English: Norbuprenorphine AUC ↑105% Norbuprenorphine cmax ↑61% Norbuprenorphine cmin ↑101%
Croatian: Norbuprenorfin Cmax ↑61% Norbuprenorfin Cmin ↑101%
English: The capsule cap is imprinted with white mark A300.
Croatian: Na kapici kapsule je utisnuta bijela oznaka A300.
English: The capsule cap is imprinted with black mark A200.
Croatian: Na kapici kapsule je utisnuta crna oznaka A200.
English: N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
Croatian: F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; sporedna supstitucija za rezistenciju na inhibitore proteaze: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
English: Co-administration of atazanavir/ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena atazanvira s ritonavirom i ovih glukokortikoida, osim ako je moguća korist od liječenja veća od rizika od sistemskih učinaka kortikosteroida (vidjeti dio 4.4).
English: a The mean baseline CD4 cell count was 337 cells/mm3 (range: 14 to 1,543 cells/mm3) and the mean baseline plasma HIV-1
Croatian: Prosječni početni broj CD4 stanica iznosio je 337 stanica/mm3 (raspon: 14 do 1543 stanica/mm3) i prosječna početna razina
English: ERECTILE DYSFUNCTION PDE5 Inhibitors Sildenafil, tadalafil, vardenafil
Croatian: Sildenafil, tadalafil, vardenafil
English: The recommended dose of Atazanavir Krka capsules is 300 mg once daily taken with ritonavir 100 mg once daily and with food.
Croatian: Preporučena doza Atazanavir Krka kapsula je 300 mg jedanput na dan i uzima se s ritonavirom u dozi od 100 mg jedanput na dan i s hranom.
English: The co-administration of stavudine with atazanavir is not expected to significantly alter the exposure of stavudine.
Croatian: Ne očekuje se da će istovremena primjena stavudina i atazanvira značajno promijeniti izloženost stavudinu.
English: No dose adjustment is needed for atazanavir.
Croatian: Nije potrebna prilagodba doze atazanvira.
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Croatian: Metabolički paramateri Tjelesna težina i razine lipida i glukoze u krvi mogu biti povećane tijekom antiretrovirusne terapije
English: Interactions with other medicinal products The combination of Atazanavir Krka with atorvastatin is not recommended (see section 4.5).
Croatian: Interakcije s drugim lijekovima Ne preporučuje se istovremena primjena lijeka Atazanavir Krka s atorvastatinom (vidjeti dio 4.5).
English: Lamotrigine should be used with caution in combination with atazanavir /ritonavir.
Croatian: Lamotrigin se mora primjenjivati uz oprez u kombinaciji s atazanvirom i ritonavirom.
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Croatian: Učestalost hepatitisa ili povišenja transaminaza koji su se u bolesnika s istovremenim infekcijama razvili tijekom liječenja atazanavirom bila je slična onoj pri primjeni komparatorskih protokola (vidjeti dio 4.4).
English: Coadministration of diltiazem and atazanavir /ritonavir has not been studied.
Croatian: Istovremena primjena diltiazema i atazanvira s ritonavirom nije ispitana.
English: How to take Atazanavir Krka
Croatian: Kako uzimati Atazanavir Krka
English: Nevirapine AUC ↑26% (↑17% Nevirapine cmax ↑21% (↑11% Nevirapine cmin ↑35% (↑25%
Croatian: Nevirapin AUC ↑26% (↑17% ↑36%) Nevirapin Cmax ↑21% (↑11% ↑32%) Nevirapin Cmin ↑35% (↑25% ↑47%)
English: HIV RNA <50 copies/ml by select baseline PI substitutions,
Croatian: HIV RNK <50 kopija/ml prema početnim odabranim supstitucijama za rezistenciju na inhibitor proteaze,
English: Study 138 is an international randomised, open-label, multicenter, prospective trial of treatment naïve patients comparing atazanavir /ritonavir (300 mg/100 mg once daily) to lopinavir/ritonavir (400 mg/100 mg twice daily), each in combination with fixed dose tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg tablets once daily).
Croatian: U odraslih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima Ispitivanje 138 međunarodno je, randomizirano, multicentrično, prospektivno ispitivanje otvorenog tipa u bolesnika koji prethodno nisu bili liječeni u kojem se atazanavir/ritonavir (300 mg/100 mg jedanput na dan) uspoređivao s lopinavirom/ritonavirom (400 mg/100 mg dvaput na dan), gdje su obje te kombinacije bile davane zajedno s fiksnom dozom tenofovirdizoproksilfumarata/emtricitabina (300 mg/200 mg tablete, jedanput na dan).
English: Atazanavir Krka with ritonavir should be used with caution in patients with mild hepatic impairment.
Croatian: Atazanavir Krka s ritonavirom treba primjenjivati s oprezom u bolesnika s blagim oštećenjem funkcije jetre.
English: f Intent-to-treat analysis, with missing values considered as failures.
Croatian: f Analiza podataka bolesnika predviđenih za liječenje, a vrijednosti koje su nedostajale smatrale su se neuspjehom.
English: shellac black ferric oxide (E172)
Croatian: šelak crni željezov oksid (E172)
English: How to store Atazanavir Krka
Croatian: Kako čuvati Atazanavir Krka
English: 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.
Croatian: 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;
English: This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Croatian: ako se smatra potrebnom, u bolesnika sa suprimiranim virusnim opterećenjem HIV-om i sa sojem
English: What Atazanavir Krka looks like and contents of the pack Atazanavir Krka 150 mg hard capsules
Croatian: Kako Atazanavir Krka izgleda i sadržaj pakiranja Atazanavir Krka 150 mg tvrde kapsule
English: The potential for PR prolongation should be considered in cases of overdose (see section
Croatian: U slučajevima predoziranja treba uzeti u obzir mogućnost produljenja PR intervala (vidjeti dio 4.9).
English: Patients should be closely monitored for tenofovir disoproxil fumarate-associated adverse reactions, including renal disorders.
Croatian: Bolesnike treba pažljivo nadzirati zbog nuspojava tenofovirdizoproksilfumarata,
English: - Gallbladder problems uncommonly happen in people taking atazanavir.
Croatian: - Manje često mogu se pojaviti problemi sa žučnim kamencima u osoba koje uzimaju atazanavir.
English: potassium hydroxide
Croatian: kalijev hidroksid
English: Co-administration of lurasidone with atazanavir is contraindicated as this may increase lurasidone-related toxicity (see section 4.3).
Croatian: Istodobna primjena lurasidona i atazanvira je kontraindicirana, jer može povećati toksičnost povezanu s primjenom lurasidona (vidjeti dio
English: 14-OH clarithromycin 14-OH clarithromycin AUC ↓70%
Croatian: 14-OH klaritromicin AUC ↓70% (↓74%
English: Grazoprevir concentrations were greatly increased when coadministered with atazanavir/ritonavir.
Croatian: Koncentracije grazoprevira su značajno porasle kada je primjenjivan istodobno s atazanavirom/ritonavirom.
English: Total rifabutin and 25-O-desacetylrifabutin AUC ↑119% (↑78%
Croatian: 25-O-dezacetil-rifabutin AUC ↑990%
English: Norgestimate AUC ↑85% (↑67% Norgestimate cmax ↑68% (↑51% Norgestimate cmin ↑102% (↑77%
Croatian: Norgestimat AUC ↑85% (↑67% ↑105%) Norgestimat Cmax ↑68% (↑51% ↑88%) Norgestimat Cmin ↑102% (↑77% ↑131%)
English: Study 045 is a randomised, multicenter trial comparing atazanavir /ritonavir (300/100 mg once daily) and atazanavir /saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
Croatian: (300/100 mg jedanput na dan) i atazanavir/sakvinavir (400/1200 mg jedanput na dan) uspoređivani s lopinavirom + ritonavirom (400/100 mg, fiksna kombinacija doza, dvaput na dan), a svaka se od tih terapija primjenjivala u kombinaciji s tenofovirdizoproksilom (vidjeti dijelove 4.5 i 4.8) i jednim NRTI-jem u bolesnika u kojih je dva ili više prethodnih protokola s najmanje jednim inhibitorom proteaze, NRTI-jem i NNRTI-jem bilo virološki neuspješno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1353/002
English: Raltegravir AUC ↑41% Raltegravir cmax ↑24% Raltegravir c12hr ↑77% The mechanism is UGT1A1 inhibition.
Croatian: Raltegravir Cmax ↑24% Raltegravir C12hr ↑77%
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1353/001
English: - Kidney stones uncommonly happen in people taking atazanavir.
Croatian: - Manje često mogu se pojaviti bubrežni kamenci u osoba koje uzimaju atazanavir.
English: Frequency de novo PI substitution (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
Croatian: M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
English: Only when atazanavir with ritonavir is co-administered with efavirenz, a dose increase of ritonavir to 200 mg once daily could be considered.
Croatian: Samo kad se atazanavir s ritonavirom primjenjuje istovremeno s efavirenzom može se razmotriti povišenje doze ritonavira na
English: The choice of Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient's treatment history (see sections 4.4 and 5.1).
Croatian: Odabir lijeka Atazanavir Krka za liječenje već liječenih odraslih i pedijatrijskih bolesnika treba biti utemeljen na pojedinačnom testiranju virusne rezistencije i prethodnom liječenju pojedinog bolesnika
English: Co-administration of Atazanavir Krka 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).
Croatian: Nije ispitana istovremena primjena lijeka Atazanavir Krka i druge hormonske ili oralne kontracepcije koja sadrži progestagene, osim norgestimata ili noretindrona, te se stoga mora izbjegavati (vidjeti dio
English: Co-administration of Atazanavir Krka with nevirapine or efavirenz is not recommended (see section 4.5).
Croatian: Ne preporučuje se istovremena primjena lijeka Atazanavir Krka s nevirapinom ili efavirenzom (vidjeti dio 4.5).
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Croatian: povišen indeks tjelesne mase mogu, između ostalog, biti neki od mnogih čimbenika rizika za razvoj ove bolesti.
English: Co-administration of voriconazole and Atazanavir Krka with ritonavir is not recommended, unless an assessment of the benefit/risk justifies the use of voriconazole.
Croatian: Ne preporučuje se istovremena primjena vorikonazola i lijeka Atazanavir Krka s ritonavirom, osim ako procjena omjera koristi i rizika opravdava primjenu vorikonazola.
English: No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg. the need to consider that co-administration of voriconazole and atazanavir without ritonavir may affect atazanavir concentrations co-administration of fluticasone and atazanavir without ritonavir may increase fluticasone concentrations relative to fluticasone given alone if an oral contraceptive is administered with atazanavir without ritonavir, it is recommended that the oral contraceptive contain no more than 30 µg of ethinyloestradiol no dose adjustment of lamotrigine is required
Croatian: - treba imati na umu da: istovremena primjena vorikonazola i atazanavira bez ritonavira može utjecati na koncentracije atazanavira istovremena primjena flutikazona i atazanavira bez ritonavira može povisiti koncentracije flutikazona u odnosu na koncentracije flutikazona primijenjenog samostalno ako se istovremeno s atazanavirom bez ritonavira primjenjuje oralni kontraceptiv,
English: Clarithromycin AUC ↑94% (↑75% Clarithromycin cmax ↑50% (↑32% Clarithromycin cmin ↑160%
Croatian: Klaritromicin AUC ↑94% (↑75% ↑116%) Klaritromicin Cmax ↑50% (↑32% ↑71%) Klaritromicin Cmin ↑160% (↑135% ↑188%)
English: (See also section 4.4 Withdrawal of ritonavir only under restrictive conditions).
Croatian: (vidjeti dijelove 4.5 i 5.1). (Vidjeti i "Prekid primjene ritonavira samo pod restriktivnim uvjetima" u dijelu 4.4).
English: 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).
Croatian: preporučuje se primijeniti 300 mg atazanvira sa 100 mg ritonavira i 300 mg tenofovirdizoproksilfumatata (svi se primjenjuju kao jednokratna doza s hranom).
English: Co-administration of Atazanavir Krka with proton pump inhibitors is not recommended (see section 4.5).
Croatian: Ne preporučuje se istovremena primjena lijeka Atazanavir Krka s inhibitorima protonske pumpe (vidjeti dio 4.5).
English: % (responder/evaluabled)
Croatian: % (bolesnici s odgovorom/bolesnici koje se moglo procijeniti d)
English: Unboosted Atazanavir Krka must not be used in patients with severe hepatic impairment.
Croatian: Nepojačani Atazanavir Krka ne smije se primjenjivati u bolesnika s teškim oštećenjem funkcije jetre.
English: Nephrolithiasis has been reported in patients receiving atazanavir (see section 4.8).
Croatian: Nefrolitijaza U bolesnika koji primaju atazanavir zabilježena je nefrolitijaza (vidjeti dio 4.8).
English: Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of these medicinal products and atazanavir is not expected to significantly alter the exposure of the co-administered medicinal products.
Croatian: Na temelju ovih podataka i budući da se ne očekuje značajan učinak ritonavira na farmakokinetiku
English: Didanosine (with food) Didanosine AUC ↓34% (↓41% ↓27%) Didanosine cmax ↓38% (↓48% ↓26%) Didanosine cmin
Croatian: Didanozin AUC ↓34% (↓41% ↓27%) Didanozin Cmax ↓38% (↓48% ↓26%) Didanozin Cmin ↑25% (↓8% ↑69%)
English: Voriconazole AUC ↑561% Voriconazole cmax ↑438% (↑355% Voriconazole cmin ↑765% (↑571%
Croatian: Vorikonazol AUC ↑561% (↑451% ↑699%) Vorikonazol Cmax ↑438% (↑355% ↑539%) Vorikonazol Cmin ↑765% (↑571%
English: Sofosbuvir 400 mg / velpatasvir 100 mg /voxilaprevir 100 mg single dose*
Croatian: Sofosbuvir 400 mg / velpatasvir 100 mg /voksilaprevir 100 mg jedna doza* (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
English: No dosage adjustment is necessary if methadone is co
Croatian: Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s atazanavirom.
English: NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 300 mg hard capsules atazanavir
Croatian: NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 300 mg tvrde kapsule atazanavir
English: * In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28).
Croatian: * U kombiniranoj analizi, atazanavir 300 mg s ritonavirom 100 mg (n=33)
English: * When compared to atazanavir 300 mg and ritonavir 100 mg without nevirapine.
Croatian: 300 mg/ritonavir 100 mg bez nevirapina.
English: Co-administration of voriconazole and atazanavir with ritonavir is not recommended unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena vorikonazola i atazanvira s ritonavirom osim kad procjena omjera koristi i rizika za bolesnika opravdava primjenu vorikonazola (vidjeti dio 4.4).
English: While the concentration of ethinyloestradiol was increased with atazanavir given alone, due to both UGT and CYP3A4 inhibition by atazanavir, the net effect of atazanavir/ritonavir is a decrease in ethinyloestradiol levels because of the inducing effect of ritonavir.
Croatian: UGT i CYP3A4, neto učinak atazanavira/ritonavira je sniženje razina etinilestradiola zbog inducirajućeg učinka ritonavira.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING CONTAINER LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA SPREMNIK
English: - grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)
Croatian: - lijekovi koji sadrže grazoprevir, ukljućujući fiksnu kombinaciju elbasvir/grazoprevir i fiksnu kombinaciju glekaprevir/pibrentasvir (koja se koristi u liječenju kronične infekcije virusom hepatitisa C) Nemojte uzimati sildenafil s lijekom Atazanavir Krka kad se sildenafil primjenjuje za liječenje plućne arterijske hipertenzije.
English: Atazanavir Krka 200 mg hard capsules Each hard capsule contains 200 mg atazanavir (as sulphate).
Croatian: Atazanavir Krka 200 mg tvrde kapsule Jedna tvrda kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
English: ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Croatian: Klaritromicin 500 mg dvaput na dan (atazanavir 400 mg jedanput na dan)
English: Atazanavir Krka is not a cure for HIV infection.
Croatian: Upozorenja i mjere opreza Atazanavir Krka neće izliječiti HIV-infekciju.
English: During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μM) of atazanavir corresponding to 30 fold the free drug concentration at cmax in humans.
Croatian: kod koncentracije (30 μM) atazanavira koja je odgovarala 30 puta većoj koncentraciji slobodnog lijeka pri Cmax u ljudi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/003 30 hard capsules EU/1/19/1353/004 90 (3 x 30) hard capsules
Croatian: EU/1/19/1353/004 90 (3 x 30) tvrdih kapsula
English: Voriconazole AUC ↓33% (↓42% Voriconazole cmax ↓10% (↓22% Voriconazole cmin ↓39% (↓49%
Croatian: Vorikonazol AUC ↓33% (↓42% ↓22%) Vorikonazol Cmax ↓10% (↓22% ↓4%) Vorikonazol Cmin ↓39% (↓49% ↓28%)
English: shellac titanium dioxide (E171) potassium hydroxide
Croatian: šelak titanijev dioksid (E171)
English: d Intent-to-treat analysis, with missing values considered as failures.
Croatian: d Analiza podataka bolesnika predviđenih za liječenje, s time da su se vrijednosti koje su nedostajale smatrale neuspjehom.
English: Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance.
Croatian: Tijekom praćenja nakon stavljanja lijeka u promet, prijavljena je kronična bubrežna bolest u bolesnika zaraženih HIV-om, liječenih atazanavirom, sa ili bez ritonavira.
English: - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation) - triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) - simvastatin and lovastatin (used to lower blood cholesterol).
Croatian: - triazolam i peroralni (uzima se kroz usta) midazolam (primjenjuje se za liječenje poremećaja spavanja i/ili ublažavanje tjeskobe)
English: QT prolongation: Dose related asymptomatic prolongations in PR interval with atazanavir have been observed in clinical studies.
Croatian: Produljenje QT intervala: U kliničkim je ispitivanjima opaženo asimptomatsko produljenje
English: In some cases, nephrolithiasis has been associated with acute renal failure or renal insufficiency.
Croatian: nefrolitijaza je povezana s akutnim zatajenjem bubrega ili bubrežnom insuficijencijom.
English: Treatment- Experienced atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=25
Croatian: Bolesnici koji su prethodno bili liječeni atazanavir kapsulama i ritonavirom (300 mg/100 mg jedanput na dan) n=25
English: 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%).
Croatian: 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
English: Co-administration of atazanavir with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination 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).
Croatian: Istodobna primjena lijeka atazanavira s lijekovima koji sadrže grazoprevir, uključujući fiksnu kombinaciju elbasvir/grazoprevir kontraindicirana je zbog povišene koncentracije grazoprevira i elbasvira u plazmi i postoji rizik povišenja vrijednosti ALT-a zbog povećane koncentracije grazoprevira (vidjeti dio 4.3).
English: Studies conducted in HIV- infected patients.
Croatian: Ispitivanja provedena u bolesnika s HIV-infekcijom.
English: Co-administration of atazanavir and indinavir is not recommended (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena atazanvira i indinavira (vidjeti dio 4.4).
English: Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving atazanavir should be evaluated for alternative aetiologies.
Croatian: Potrebno je provjeriti alternativne uzroke povišenja jetrenih transaminaza koje može nastati uz povišenje bilirubina u bolesnika koji primaju atazanavir.