FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovak: odporúča sa, aby sa podával atazanavir 300 mg so 100 mg ritonaviru a 300 mg tenofovirdizoproxilfumarátu (všetky ako jednorazová dávka s jedlom).
English: Norbuprenorphine AUC ↑105% Norbuprenorphine cmax ↑61% Norbuprenorphine cmin ↑101%
Slovak: % Norbuprenorfín Cmin ↑101
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).
Slovak: lieky obsahujúce ľubovník bodkovaný (Hypericum perforatum, rastlinný prípravok); triazolam a perorálny (užívaný ústami) midazolam (používané na zlepšenie spánku a/alebo zmiernenie úzkosti); simvastatín alebo lovastatín (používajú sa na zníženie cholesterolu v krvi) lieky obsahujúce grazoprevir, vrátane kombinácie fixnej dávky elbasviru/grazopreviru
English: Treatment- Experienced atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=25
Slovak: Pacienti s predchádzajúcou liečbou kapsulami atazanaviru/ritonaviru (300 mg/100 mg jedenkrát denne) n=25
English: In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen (see section 4.4) The same recommendations for drug drug interactions would apply except: that co-administration is not recommended with tenofovir, boceprevir, carbamazepine, phenytoin, phenobarbital, proton pump inhibitors, and buprenorphine.
Slovak: Budú platiť rovnaké odporúčania interakcií liečiv s výnimkou: - že sa súbežné podávanie neodporúča s tenofovirom, boceprevirom, karbamazepínom,
English: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020)
Slovak: Tabuľka 7: Výsledky účinnosti (pediatrickí pacienti vo veku od 6 rokov do menej ako 18 rokov) v
English: 86 (n=392f)
Slovak: 86 (n=392
English: 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.
Slovak: Ak je potrebné podať vyššiu dávku antagonistu H2receptora (napr. famotidín 40 mg dvakrát denne alebo iný ekvivalent),
English: 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.
Slovak: ktorí užívali atazanavir 300 mg s ritonavirom 100 mg raz denne, okrem žltačky a zvýšenia hladín celkového bilirubínu, ktoré boli častejšie hlásené pri kombinovanom podávaní atazanaviru plus ritonaviru.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Slovak: Boli hlásené prípady osteonekrózy, najmä u pacientov so všeobecne uznávanými rizikovými faktormi,
English: HIV RNA <50 copies/ml, %f (responder/evaluable) All patients
Slovak: HIV RNA <50 kópií/ml podľa východiskových PI substitúcií,f,g % (respondent/vyhodnotenie)
English: Ethinyloestradiol AUC ↓19% Ethinyloestradiol cmax ↓16% Ethinyloestradiol cmin ↓37%
Slovak: Etinylestradiol Cmax ↓16
English: CD4 Mean Change from Baseline, cells/mm by Baseline Characteristic
Slovak: Priemerná zmena počiatočného počtu CD4, bunky/mm na základe počiatočných vlastností
English: H2-Receptor antagonists Without Tenofovir disoproxil In HIV-infected patients with atazanavir/ritonavir at the recommended dose 300/100 mg once daily
Slovak: U HIV infikovaných pacientov s atazanavirom/ritonavirom pri odporúčanej dávke 300/100 mg raz denne
English: No dosage adjustment is necessary if methadone is co
Slovak: Nie je potrebná úprava dávkovania, ak sa metadon podáva súbežne s atazanavirom.
English: Hard gelatine capsule (capsule), size no. 1.
Slovak: Tvrdá želatínová kapsula (kapsula), veľkosť č. 1.
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%).
Slovak: 100 mg raz denne boli bez ohľadu na závažnosť najčastejšie hlásenými nežiaducimi reakciami, u ktorých sa predpokladala aspoň minimálna súvislosť s režimom zahŕňajúcim atazanavir a jeden alebo viac NRTI: nauzea (20
English: 25-O-desacetyl-rifabutin AUC 25-O-desacetyl-rifabutin cmax 25-O-desacetyl-rifabutin cmin
Slovak: 25-O-desacetyl-rifabutín Cmax ↑677
English: Atazanavir Krka with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Slovak: Atazanavir Krka s ritonavirom sa neodporúča u pacientov podrobujúcich sa hemodialýze (pozri časti 4.4 a 5.2).
English: All patients HIV RNA <400 copies/ml, %
Slovak: HIV RNA <400 kópií/ml,
English: Therefore, Atazanavir Krka 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).
Slovak: Atazanavir Krka s ritonavirom kontraindikovaný pri podávaní s liekmi, ktoré sú substrátmi CYP3A4 a majú úzky terapeutický index: kvetiapín, lurazidón, alfuzosín, astemizol, terfenadín, cisaprid, pimozid,
English: Atazanavir Krka 150 mg hard capsules
Slovak: Atazanavir Krka 150 mg tvrdé kapsuly
English: Atazanavir Krka capsules, co-administered with low dose ritonavir, are 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).
Slovak: 1 infikovaných dospelých a pediatrických pacientov od 6 rokov veku a starších v kombinácii s inými antiretrovírusovými liekmi (pozri časť 4.2).
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily)
Slovak: ANTIRETROVIROTIKÁ PROTI HCV Grazoprevir 200 mg raz denne (atazanavir 300 mg / ritonavir 100 mg raz denne)
English: For treatment-naive paediatric patients, the mean baseline CD4 cell count was 344 cells/mm3 (range: 2 to 800 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
Slovak: buniek/mm3 (rozsah: 2 až 800 buniek/mm3) a priemerná východisková hladina HIV 1 RNA v plazme bola 4,67 log10 kópií/ml (rozsah: 3,70 až 5,00 log10 kópií/ml).
English: Elbasvir 50 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily)
Slovak: Elbasvir 50 mg raz denne (atazanavir 300 mg / ritonavir 100 mg raz denne)
English: Atazanavir Krka 300 mg hard capsules
Slovak: Atazanavir Krka 300 mg tvrdé kapsuly
English: 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.
Slovak: kombinované štúdie) bol priemerný polčas v rozsahu dávkovacieho intervalu pre atazanavir 12 hodín v rovnovážnom stave po dávke 300 mg denne s ritonavirom 100 mg denne s ľahkým jedlom.
English: 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.
Slovak: potkanov a psov pri dávkach spájaných s hepatálnymi zmenami boli prinajmenšom rovnaké ako tie,
English: If an oral contraceptive is administered with atazanavir/ritonavir, it is recommended that the oral contraceptive contain at least 30 μg of ethinyloestradiol and that the patient be reminded of strict compliance with this contraceptive dosing regimen.
Slovak: odporúča sa, aby perorálne kontraceptívum obsahovalo aspoň 30 μg etinylestradiolu,
English: The mechanism of this interaction is CYP3A4 inhibition.
Slovak: Mechanizmus tejto interakcie je inhibícia CYP3A4
English: 293 (n=14b)
Slovak: 293 (n=14
English: Co-administration of salmeterol and Atazanavir Krka is not recommended (see section 4.5).
Slovak: Súbežné podávanie salmeterolu a Atazanaviru Krka sa neodporúča (pozri časť 4.5).
English: 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).
Slovak: chinidín, bepridil, triazolam, midazolam podávaný perorálne (opatrnosť pri parenterálnom podávaní midazolamu, pozri časť 4.5) a námeľové alkaloidy, najmä ergotamín, dihydroergotamín, ergonovín, metylergonovín) (pozri časť 4.5).
English: Tenofovir disoproxil fumarate Cmin
Slovak: Tenofovir-dizoproxilfumarát Cmax ↑34
English: Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving atazanavir should be evaluated for alternative aetiologies.
Slovak: Odlišné etiológie sa majú posúdiť v prípadoch zvýšenia hepatálnej transaminázy, ktorá sa vyskytne spolu so zvýšenou hladinou bilirubínu u pacientov liečených atazanavirom.
English: For patients not taking tenofovir disoproxil, if atazanavir 300 mg/ritonavir 100 mg and H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Slovak: U pacientov, ktorí užívajú tenofovir, ak sú atazanavir 300 mg/ritonavir 100 mg a antagonisty H2-receptorov podávané súbežne,
English: Atazanavir (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 Child-Pugh Class C subjects) after a single 400 mg dose.
Slovak: Atazanavir (bez ritonaviru) sa skúmal u dospelých jedincov so stredne ťakou až ťažkou poruchou funkcie pečene (14
English: 300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil
Slovak: S tenofovir-dizoproxilfumarátom 300 mg raz denne (čo zodpovedá 245 mg tenofovir-dizoproxilu)
English: Co-administration of atazanvir with glecaprevir/pibrentasvir is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3)
Slovak: Súbežné podávanie atazanaviru s glekaprevirom/pibrentasvirom je kontraindikované, pretože sa potenciálne zvyšuje riziko vzostupov ALT z dôvodu významného zvýšenia plazmatických koncentrácií glekapreviru a pibrentasviru (pozri časť 4.3).
English: Eleven subjects (13%) in the unboosted atazanavir group and 6 (7%) in the atazanavir + ritonavir group, had virologic rebound.
Slovak: %) v skupine s atazanavirom + ritonavirom malo virologický rebound.
English: diltiazem, systemic lidocaine, verapamil) - atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) - salmeterol (used to treat asthma) - cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) - certain antibiotics (rifabutin, clarithromycin) - ketoconazole, itraconazole, and voriconazole (antifungals) - warfarin (anticoagulant, used to reduce the blood clots) - carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) - irinotecan (used to treat cancer) - sedative agents (e.g. midazolam administered by injection) - buprenorphine (used to treat opioid addiction and pain).
Slovak: niektoré antibiotiká (rifabutín, klaritromycín) ketokonazol, itrakonazol a vorikonazol (fungicída) warfarín (antikoagulancium, používané na zníženie zrážania krvi) karbamazepín, fenytoín, fenobarbiral, lamotrigín (antiepileptiká)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/002
Slovak: EU/1/19/1353/002
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg atazanavir (as sulphate).
Slovak: Každá tvrdá kapsula obsahuje 200 mg atazanaviru (vo forme sulfátu).
English: Your doctor should do blood tests prior you start Atazanavir Krka and during treatment.
Slovak: Pred začatím liečby Atazanavirom Krka a počas liečby má lekár robiť vyšetrenia krvi.
English: Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with atazanavir (see section 4.4).
Slovak: Pacienti majú byť upozornení na tieto možné nežiaduce účinky pri používaní PDE5
English: 229 (n=14b)
Slovak: 229 (n=14
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 300 mg atazanavir (as sulphate).
Slovak: Každá tvrdá kapsula obsahuje 300 mg atazanaviru (vo forme sulfátu).
English: Capsule shell of Atazanavir Krka 150 mg hard capsules:
Slovak: Obal kapsuly Atazanavir Krka 150 mg tvrdé kapsuly:
English: Caution should be exercised when verapamil is coadministered with atazanavir.
Slovak: Odporúča sa opatrnosť, ak sa verapamil podáva súbežne s atazanavirom.
English: If necessary, monitor carbamazepine serum concentrations and adjust the dose accordingly.
Slovak: monitorujte sérové koncentrácie karbamazepínu a príslušne upravte expozície atazanaviru.
English: administered with atazanavir.
Slovak: Čo Atazanavir
English: If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately.
Slovak: Ak sa u vás prejavia prejavy alebo príznaky obličkových kameňov (bolesť na boku, krv v moči, bolesť pri močení),
English: Hard gelatine capsule, size no. 1.
Slovak: Tvrdá želatínová kapsula, veľkosť č. 1.
English: Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving atazanavir (see section 4.8).
Slovak: U pacientov užívajúcich atazanavir sa vyskytli prípady reverzibilného zvýšenia nepriameho (nekonjugovaného) bilirubínu súvisiaceho s inhibíciou UDP-glukuronyltransferázy (UGT) (pozri časť
English: Expected:
Slovak: Očakávané: ↔
English: Raltegravir AUC ↑41% Raltegravir cmax ↑24% Raltegravir c12hr ↑77% The mechanism is UGT1A1 inhibition.
Slovak: % Raltegravir C12hr ↑77
English: 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.
Slovak: ritonavir a lopinavir + ritonavir splnili kritériá neinferiority založené na pozorovaných prípadoch.
English: 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.
Slovak: ktoré sa môžu vyskytnúť aj u iných kortikosteroidov metabolizovaných dráhou cytochrómu P450 3A, napr. budezonid.
English: Atazanavir Krka with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Slovak: Atazanavir Krka s ritonavirom je kontraindikovaný u pacientov so stredne ťažkou insuficienciou pečene (pozri časti 4.2, 4.4 a 5.2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg atazanavir (as sulphate).
Slovak: Každá tvrdá kapsula obsahuje 150 mg atazanaviru (vo forme sulfátu).
English: The recommended adult dose of Atazanavir Krka capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines.
Slovak: 100 mg ritonaviru raz denne s jedlom v kombinácii s inými liekmi proti HIV.
English: HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Slovak: Ľubovník bodkovaný (Hypericum perforatum) (pozri časť
English: Co-administration of quetiapine with atazanavir is contraindicated as atazanavir may increase quetiapine-related toxicity.
Slovak: pretože atazanavir môže zvýšiť toxicitu týkajúcu sa kvetiapínu.
English: ANTIMYCOBACTERIAL Rifabutin 150 mg twice weekly (atazanavir 300 mg and ritonavir 100 mg once daily)
Slovak: Rifabutín 150 mg dvakrát týždenne (atazanavir 300 mg a ritonavir 100 mg raz denne)
English: Norethindrone cmax ↑67% (↑42% Norethindrone cmin ↑262%
Slovak: Noretindrón Cmin ↑262
English: Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine and ink (shellac, black ferric oxide (E172), potassium hydroxide
Slovak: Viečko: oxid titaničitý (E171), žltý oxid železitý (E172), červený oxid železitý (E172), želatína a atrament (šelak, čierny oxid železitý (E172), hydroxid draselný
English: shellac titanium dioxide (E171) potassium hydroxide
Slovak: šelak oxid titaničitý (E171)
English: Table 8: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg
Slovak: Tabuľka 8: Farmakokinetika atazanaviru s ritonavirom v rovnovážnom stave u HIV
English: 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%).
Slovak: + ritonavirom a dvoma NRTI (n=85) u jedincov infikovaných HIV s úplnou supresiou replikácie HIV podľa hodnotenia pomocou podielu jedincov s HIV RNA < 50 kópiami/ml: 78 % jedincov s atazanavirom bez zosilneného účinku a dvoma NRTI v porovnaní so 75% s atazanavirom +
English: CORTICOSTEROIDS Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules twice daily)
Slovak: Flutikazónpropionát intranazálne 50 μg 4-krát denne počas 7 dní
English: Co-administration with atazanavir may result in increased concentrations of salmeterol and an increase in salmeterolassociated adverse events.
Slovak: Súbežné podávanie salmeterolu s atazanavirom sa salmeterolu a zvýšiť nežiaduce udalosti spojené so salmeterolom.
English: HIV RNA Mean Change from Baseline, log10 copies/ml
Slovak: Priemerná zmena počiatočného počtu HIV RNA, log10 kópií/ml
English: The recommended dose of Atazanavir Krka capsules is 300 mg once daily taken with ritonavir 100 mg once daily and with food.
Slovak: Krka je 300 mg raz denne podávaná s ritonavirom v dávke 100 mg raz denne s jedlom.
English: 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.
Slovak: %) žien na atazanavir e/ritonavire 400/100 mg sa vyskytla hyperbilirubinémia 3. až 4. stupňa.
English: 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.
Slovak: %) narodených ženám liečeným atazanavirom/ritonavirom 300/100 mg a u štyroch z 20 detí (20
English: flatulence (wind), dry mouth, abdominal distension - angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) - alopecia (unusual hair loss or thinning), pruritus (itching) - muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles)
Slovak: roztiahnutie žalúdka angioedém (závažný opuch kože a iných tkanív, najčastejšie pier alebo očí) alopécia (nezvyčajná strata vlasov alebo rednutie), pruritus (svrbenie) svalová atrofia (strata svaloviny), artralgia (bolesť kĺbov), myalgia (svalová bolesť) intersticiálna nefritída (zápal obličiek), hematúria (krv v moči), proteinúria (nadbytok bielkovín v moči), polakizúria (zvýšená frekvencia močenia) gynekomastia (zväčšenie pŕs u mužov) bolesť na hrudníku, nepokoj (všeobecne pocit choroby), horúčka insomnia (ťažkosti so spánkom)
English: Didanosine should be taken at the fasted state 2 hours after atazanavir taken with food.
Slovak: hodiny po podaní atazanaviru užitého s jedlom.
English: Tenofovir disoproxilfumarate AUC ↑37% (↑30% ↑45%) Tenofovir disoproxil fumarate Cmax
Slovak: % Tenofovir-dizoproxilfumarát Cmin ↑29 %
English: the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Slovak: Mechanizmus interakcie klaritromycínu/atazanaviru je CYP3A4 inhibícia.
English: Hard gelatine capsule, size no. 00.
Slovak: Tvrdá želatínová kapsula, veľkosť č. 00.
English: Ethinyloestradiol AUC ↑48% Ethinyloestradiol cmax ↑15% (↓1% Ethinyloestradiol cmin ↑91%
Slovak: Etinylestradiol Cmax ↑15
English: Tell your doctor immediately if you develop any of the following serious side effects:
Slovak: Ak sa u vás vyvinie ktorýkoľvek z nasledovných závažných vedľajších účinkov, okamžite to povedzte lekárovi:
English: The risk of a further decrease in atazanavir exposure is expected when atazanavir is given with medicinal products known to reduce its exposure (e.g., tenofovir disoproxil or H2-receptor antagonists).
Slovak: Ak sa atazanavir podáva s liekmi, o ktorých je známe, že znižujú expozíciu atazanaviru (napr.
English: When given with atazanavir, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Slovak: mg 3-krát týždenne v stanovených dňoch (napríklad pondelok-streda piatok).
English: 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.
Slovak: U pacientov infikovaných HIV (n=13) viedlo opakované podávanie atazanaviru 400 mg (bez ritonaviru) jedenkrát denne s jedlom ku geometrickému priemeru (CV%)
English: Hard gelatine capsule (capsule), size no. 00.
Slovak: Tvrdá želatínová kapsula (kapsula), veľkosť č. 00.
English: In in vivo studies in rats, atazanavir did not induce micronuclei in bone marrow, DNA damage in duodenum (comet assay), or unscheduled DNA repair in liver at plasma and tissue concentrations exceeding those that were clastogenic in vitro.
Slovak: (stanovenie komét) alebo neplánovanú reparáciu DNA v pečeni pri plazmatických a tkanivových koncentráciách prevyšujúcich koncentrácie, ktoré boli klastogénne in vitro.
English: Atazanavir Krka 200 mg hard capsules
Slovak: Atazanavir Krka 200 mg tvrdé kapsuly
English: If the combination of Atazanavir Krka with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of Atazanavir Krka to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded.
Slovak: Krka s inhibítormi protónovej pumpy nevyhnutná, odporúča sa starostlivé klinické monitorovanie kombinácie so zvýšenou dávkou Atazanaviru Krka na 400 mg so
English: However, Atazanavir Krka is not recommended in patients undergoing haemodialysis (see sections 4.2 and
Slovak: Atazanavir Krka sa však neodporúča u pacientov podrobujúcich sa hemodialýze (pozri časti 4.2 a 5.2).
English: Studies conducted in HIV- infected patients
Slovak: Štúdie vykonané na HIV infikovaných pacientoch
English: (atazanavir 400 mg once daily)
Slovak: noretindrón (atazanavir 400 mg raz denne)
English: Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), black ferric oxide (E172), gelatine and ink (shellac, titanium dioxide (E171), potassium hydroxide
Slovak: Telo: oxid titaničitý (E171), žltý oxid železitý (E172), červený oxid železitý (E172) a želatína Viečko: oxid titaničitý (E171), žltý oxid železitý (E172), červený oxid železitý (E172), želatína a atrament (šelak, čierny oxid železitý (E172), hydroxid draselný
English: Alternative antiretroviral therapy to Atazanavir Krka may be considered if jaundice or scleral icterus is unacceptable to a patient.
Slovak: Ak je žltačka alebo sklérový ikterus neakceptovateľná pacientom, je možné zvážiť alternatívnu antiretrovírusovú terapiu namiesto Atazanaviru Krka.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Slovak: LIEKOVÁ FORMA A OBSAH