FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE08
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zaviralci proteaz, oznaka ATC: J05AE08
English: Mean urinary excretion of unchanged drug was 7% following 2 weeks of dosing at 800 mg once daily.
Slovenian: Povprečno izločanje nespremenjenega zdravila v urinu je bilo 7% po 2 tednih uporabe v odmerku 800 mg enkrat na dan.
English: The compound selectively inhibits the virus-specific processing of viral Gag-Pol proteins in HIV-1 infected cells, thus preventing formation of mature virions and infection of other cells.
Slovenian: Spojina selektivno zavira virusno specifične beljakovine Gag-Pol v celicah, okuženih s HIV-1, tako da prepreči nastajanje dozorelih virionov in s tem okužbo drugih celic.
English: A dose reduction of clarithromycin may result in subtherapeutic concentrations of 14-OH clarithromycin.
Slovenian: Pri zmanjšanju odmerka klaritromicina lahko pride do subterapevtskih koncentracij 14-OH klaritromicina.
English: b See description of selected adverse reactions for more details.
Slovenian: b Za več podrobnosti glejte Opis izbranih neželenih učinkov v nadaljevanju.
English: Your doctor will discuss with you which combination of these medicines with REYATAZ is best for you.
Slovenian: Z zdravnikom se posvetujte, kakšna kombinacija anti-HIV zdravil z zdravilom REYATAZ bi bila za vas najboljša.
English: Aspartame provides a source of phenylalanine and, therefore, may not be suitable for persons with phenylketonuria.
Slovenian: Aspartam je vir fenilalanina in zato morda ne bo primeren za ljudi s fenilketonurijo.
English: (See also section 4.4 Withdrawal of ritonavir only under restrictive conditions).
Slovenian: (Glejte tudi poglavje 4.4 Odtegnitev ritonavirja le v omejenih pogojih).
English: When treating HIV infection, it is not always easy to identify what side effects are caused by REYATAZ, by the other medicines you are taking, or by the HIV infection itself.
Slovenian: Pri zdravljenju okužbe s HIV ni vedno lahko ugotoviti ali so neželeni učinki posledica jemanja zdravila REYATAZ ali drugih zdravil, ki jih jemljete, ali so posledica okužbe s HIV.
English: Elimination: following a single 400 mg dose of
Slovenian: Izločanje: po enkratnem 400-mg odmerku s
English: Always give your child the medicine within 60 minutes of mixing.
Slovenian: Zdravilo dajte otroku v 60 minutah po pripravi mešanice.
English: Age/Gender: a study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
Slovenian: Starost/spol: farmakokinetične študije atazanavirja so bile izvedene pri 59 zdravih preiskovancih in preiskovankah (29 mladih, 30 starejših).
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Slovenian: Lahko vam škoduje, če imate fenilketonurijo, redko genetsko bolezen pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when coadministered with protease inhibitors.
Slovenian: Čeprav ni bilo raziskovano, obstaja možnost za povečano izpostavljenost pravastatinu ali fluvastatinu ob sočasni uporabi z zaviralci proteaz.
English: Difference estimate [95% CI]d
Slovenian: Ocenjena razlika [95% interval zaupanja]d
English: To enhance bioavailability and minimise variability, REYATAZ is to be taken with food.
Slovenian: Zaradi boljše biološke uporabnosti in zmanjšanja variabilnosti je treba zdravilo REYATAZ jemati skupaj s hrano.
English: Take REYATAZ capsules with food (a meal or a substantial snack).
Slovenian: Kapsule REYATAZ vzemite skupaj s hrano (s kosilom ali z obilnejšim obrokom).
English: The mechanism of this decrease is unknown (see sections 4.2 and 4.4.
Slovenian: Mehanizem za to zmanjšanje ni znan (glejte poglavji 4.2 in 4.4).
English: It should always be used with a low dose of ritonavir and in combination with other anti-HIV medicines.
Slovenian: Zdravilo je treba vedno jemati skupaj z nizkim odmerkom ritonavirja in v kombinaciji z drugimi zdravili proti HIV.
English: 1.3 g of sucrose per sachet.
Slovenian: 1,3 g saharoze na vrečico.
English: LIST OF EXCIPIENTS Excipients: contains lactose (see leaflet for further information).
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: vsebuje laktozo (za nadaljnje informacije glejte navodilo za uporabo).
English: ANTIEPILEPTICS Carbamazepine
Slovenian: ANTIEPILEPTIKI Karbamazepin
English: The 24 hour concentration following a high fat meal was increased by approximately 33% due to delayed absorption; the median Tmax increased from 2.0 to 5.0 hours.
Slovenian: Po obroku, bogatem z maščobami, se je zaradi zakasnele absorpcije 24-urna koncentracija povečala za približno 33%; srednji čas Tmax se je podaljšal iz 2,0 na 5,0 ur.
English: Off white to pale yellow powder.
Slovenian: Sivobeli do svetlo rumeni prašek.
English: AI424-397 (PRINCE I): In paediatric patients from 3 months to less than 6 years of age
Slovenian: AI424-397 (PRINCE I): pri pediatričnih bolnikih, starih od 3 mesece do manj kot 6 let.
English: REYATAZ should not be used in children less than 3 months because of safety concerns especially taking into account the potential risk of kernicterus.
Slovenian: Zdravila REYATAZ se ne sme uporabljati pri otrocih, mlajših od 3 mesecev, zaradi težav z varnostjo, še posebej je treba upoštevati možno tveganje za pojav kernikterusa.
English: If you forget to take REYATAZ
Slovenian: Če ste pozabili vzeti zdravilo REYATAZ
English: If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom preden vzamete to zdravilo.
English: Lurasidone
Slovenian: Lurasidon
English: - The active substance is atazanavir.
Slovenian: - Učinkovina je atazanavir.
English: that co-administration with famotidine is not recommended but if required, atazanavir without ritonavir should be administered either 2 hours after famotidine or 12 hours before.
Slovenian: sočasna uporaba s famotidinom ni priporočljiva, če pa je potrebna, mora bolnik atazanavir brez ritonavirja vzeti 2 uri po famotidinu ali 12 ur pred famotidinom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 50 mg
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy Swords Laboratories T/A Lawrence Laboratories, Unit 12, The Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare, Ireland
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italija Swords Laboratories T/A Lawrence Laboratories, Unit 12, The Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare, Irska
English: Make sure that you read and understand these instructions before giving this medicine to your child.
Slovenian: Navodila natančno preberite preden začnete to zdravilo dajati otroku.
English: * Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Slovenian: * Poročali so o vplivu atazanavirja in ritonavirja na prvi odmerek glecaprevirja in pibrentasvirja.
English: During postpartum: Following a possible decrease in atazanavir exposure during the second and third trimester, atazanavir exposures might increase during the first two months after delivery (see section 5.2).
Slovenian: Poporodno obdobje: Po morebitnem zmanjšanju izpostavljenosti atazanavirju med drugim in tretjim trimesečjem nosečnosti, se lahko izpostavljenost atazanavirju poveča v prvih dveh mesecih po porodu (glejte poglavje 5.2).
English: REYATAZ with food and drink See section 3 How to take REYATAZ.
Slovenian: Zdravilo REYATAZ skupaj s hrano in pijačo Glejte poglavje 3 Kako jemati zdravilo REYATAZ.
English: (See section 4.4 Withdrawal of ritonavir only under restrictive conditions).
Slovenian: (Glejte poglavje 4.4 Odtegnitev ritonavirja le v omejenih pogojih).
English: REYATAZ is not a cure for HIV infection.
Slovenian: Zdravilo REYATAZ ne ozdravi okužbe s HIV.
English: Antiviral activity in vitro: atazanavir exhibits anti-HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Slovenian: Protivirusno delovanje in vitro: atazanavir na celičnih kulturah kaže anti-HIV-1 aktivnost (vključno z vsemi testiranimi sevi) in anti-HIV-2 aktivnost.
English: REYATAZ given without ritonavir should not be used in pregnant patients given that it could result of suboptimal exposure of particular concern for the mother infection and vertical transmission.
Slovenian: Zdravila REYATAZ brez ritonavirja se ne sme uporabljati pri nosečnicah, saj možna suboptimalna izpostavljenost predstavlja pomembno tveganje za okužbo matere in vertikalni prenos.
English: REYATAZ 300 mg with ritonavir 100 mg may not provide sufficient exposure to atazanavir, especially when the activity of atazanavir or the whole regimen may be compromised due to drug resistance.
Slovenian: Uporaba zdravila REYATAZ 300 mg z ritonavirjem 100 mg morda ne bo zagotovila ustrezne izpostavljenosti atazanavirju, še posebej kadar je učinkovitost atazanavirja ali celotnega režima zdravljenja ogrožena zaradi odpornosti na zdravilo.
English: None of the de novo substitutions (see Table 4) are specific to atazanavir and may reflect reemergence of archived resistance on atazanavir + ritonavir in Study 045 treatment-experienced population.
Slovenian: Nobena od novih substitucij (glejte preglednico 4) ni specifična za atazanavir in lahko kaže na ponoven pojav arhivirane odpornosti na atazanavir + ritonavir pri predhodno že zdravljenih bolnikih v študiji 045.
English: Assessment of the pharmacokinetics, safety, tolerability, and efficacy of REYATAZ is based on data from the open-label, multicenter clinical trial AI424-020 conducted in patients from 3 months to 21 years of age.
Slovenian: Ocena farmakokinetike, varnosti, prenašanja zdravila s strani bolnikov in učinkovitosti zdravila REYATAZ temelji na podatkih iz odprtega, multicentričnega kliničnega preskušanja AI424-020, ki je bilo izvedeno pri bolnikih, starih od 3 mesece do 21 let.
English: REYATAZ contains lactose.
Slovenian: Zdravilo REYATAZ vsebuje laktozo.
English: Table 7: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020)
Slovenian: Preglednica 7: Izidi učinkovitosti (pediatrični bolniki, stari od 6 do manj kot 18 let) v 48. tednu (študija AI424-020)
English: SEDATIVES Benzodiazepines
Slovenian: SEDATIVI Benzodiazepini
English: REYATAZ is an antiviral (or antiretroviral) medicine.
Slovenian: REYATAZ je zdravilo, ki deluje proti virusom (ali retrovirusom).
English: Immunosuppressants Cyclosporin Tacrolimus Sirolimus
Slovenian: Imunosupresivi Ciklosporin Takrolimus Sirolimus
English: Talk to your doctor or pharmacist before taking REYATAZ and make sure your doctor knows: if you have hepatitis B or C if you develop signs or symptoms of gall stones (pain at the right side of your stomach) if you have type A or B haemophilia if you require haemodialysis
Slovenian: Pred začetkom jemanja zdravila REYATAZ se posvetujte z zdravnikom ali farmacevtom in se prepričajte, da vaš zdravnik ve: če imate hepatitis B ali C, če se pojavijo znaki ali simptomi žolčnih kamnov (bolečina v desnem predelu trebuha), če imate hemofilijo tipa A ali B, če se zdravite s hemodializo.
English: Metabolism: studies in humans and in vitro studies using human liver microsomes have demonstrated that atazanavir is principally metabolised by CYP3A4 isozyme to oxygenated metabolites.
Slovenian: Presnova: študije pri ljudeh in študije in vitro na človeških jetrnih mikrosomih so pokazale, da se atazanavir v glavnem presnavlja z izoencimom CYP3A4 v oksigenirane metabolite.
English: Wait and take or give the next dose at its regular time.
Slovenian: Počakajte in vzemite ali dajte naslednji odmerek ob običajnem času.
English: b Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Slovenian: b Deset bolnikov je v izhodišču imelo fenotipsko odpornost na atazanavir + ritonavir (razmerje spremembe (“fold change” [FC]) >5,2).
English: Although this study presented some limitations (i.e., unbound drug concentrations not studied), results suggested that the atazanavir pharmacokinetic parameters were decreased by 30% to 50% in patients undergoing haemodialysis compared to patients with normal renal function.
Slovenian: Študija ima sicer nekaj omejitev (npr. ni vrednotila koncentracij nevezanega zdravila), vendar pa rezultati kažejo, da se v primerjavi z bolniki z normalnim delovanjem ledvic pri bolnikih, ki se zdravijo s hemodializo, farmakokinetični parametri atazanavirja zmanjšajo za 30% do 50%.
English: Table 8: Efficacy Outcomes for oral powder (paediatric patients at least 3 months of age and weighing at least 5 kg) at Week 48 (Studies AI424-397 and AI424-451) Parameter
Slovenian: Preglednica 8: Izidi učinkovitosti za peroralni prašek (pediatrični bolniki, stari najmanj 3 mesece in s telesno maso najmanj 5 kg) v 48. tednu (študiji AI424-397 in AI424-451) Parameter
English: ANTICOAGULANTS Warfarin
Slovenian: ANTIKOAGULANTI Varfarin
English: What you need to know before you take REYATAZ
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo REYATAZ
English: What REYATAZ is and What it is used for
Slovenian: Kaj je zdravilo REYATAZ in za kaj ga uporabljamo
English: - The other ingredients are aspartame (E951), sucrose and orange vanilla flavour.
Slovenian: - Druge sestavine zdravila so aspartam (E951), saharoza in aroma pomaranče ter vanilije.
English: If you stop taking REYATAZ Do not stop taking REYATAZ before talking to your doctor.
Slovenian: Če ste prenehali jemati zdravilo REYATAZ Zdravila REYATAZ ne smete prenehati jemati, dokler se ne posvetujete z zdravnikom.
English: Excipient with known effect: 63 mg of aspartame; 1305.15 mg of sucrose per sachet (1.5 g oral powder).
Slovenian: Pomožna snov z znanim učinkom: 63 mg aspartama; 1.305,15 mg saharoze na vrečico (1,5 g peroralnega praška).
English: If you miss a dose or if you forget to give your child a dose, take or give the missed dose as soon as possible with food and then take or give the next scheduled dose at its regular time.
Slovenian: Če ste pozabili vzeti odmerek ali ste otroku pozabili dati odmerek, pozabljeni odmerek vzemite ali dajte čimprej skupaj s hrano in nato vzemite ali dajte naslednji predvideni odmerek ob običajnem času.
English: Other medicines and REYATAZ
Slovenian: Druga zdravila in zdravilo REYATAZ
English: Assessment of adverse reactions for REYATAZ is based on safety data from clinical studies and postmarketing experience.
Slovenian: Ocena neželenih učinkov zdravila REYATAZ temelji na podatkih o varnosti zdravila, pridobljenih iz kliničnih preskušanj in iz izkušenj v obdobju trženja zdravila.
English: REYATAZ once daily dose ritonavir once daily dose at least 5 to less than 15
Slovenian: Ritonavir, odmerek enkrat na dan najmanj 5 do manj kot 15
English: Contents of the pack and other information What REYATAZ contains - The active substance is atazanavir.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo REYATAZ - Učinkovina je atazanavir.
English: For details on preparation and administration of the REYATAZ oral powder and Instructions for Use, see section 6.6.
Slovenian: Za podrobnosti glede priprave in dajanja zdravila REYATAZ peroralni prašek in navodila za uporabo glejte poglavje 6.6.
English: Co-administration with a high-fat meal did not affect the AUC of atazanavir relative to fasting conditions and the Cmax was within 11% of fasting values.
Slovenian: Uporaba skupaj z obrokom, bogatim z maščobami, ni vplivala na vrednost AUC atazanavirja v primerjavi z uporabo na tešče, vrednost Cmax pa je ostala znotraj 11% vrednosti na tešče.
English: Fifteen of 120 (13%) patients in the REYATAZ + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90.
Slovenian: Petnajst od 120 (13%) bolnikov v skupini z zdravilom REYATAZ + ritonavirjem in 17 od 123 (14%) bolnikov v skupini z lopinavirjem + ritonavirjem je imelo štiri ali več PI substitucij L10, M46, I54, V82, I84 in L90.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/267/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/267/012
English: Atazanavir binds to both alpha-1-acid glycoprotein (AAG) and albumin to a similar extent (89% and 86%, respectively, at 1,000 ng/ml).
Slovenian: Atazanavir se v podobni meri veže na alfa-1-kisli glikoprotein in na albumin (89% na prvega in 86% na drugega pri 1.000 ng/ml).
English: Grade 3 or 4 elevation of total bilirubin was noted in 37% (6% Grade 4).
Slovenian: Zvišanje vrednosti celotnega bilirubina 3. ali 4. stopnje so zabeležili pri 37% bolnikov (4. stopnje pri 6% bolnikov).
English: The withdrawal of ritonavir from the boosted regimen of REYATAZ is not recommended, but may be considered in adults patients at the dose of 400 mg once daily with food only under the following combined restrictive conditions:
Slovenian: Odtegnitev ritonavirja iz okrepljenega režima zdravljenja z zdravilom REYATAZ ni priporočljiva, se pa o njej lahko razmisli pri odraslih bolnikih pri uporabi odmerka 400 mg enkrat na dan skupaj s hrano, vendar le ob upoštevanju vseh naslednjih omejitvenih pogojev:
English: PHARMACEUTICAL FORM AND CONTENTS Oral Powder
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA peroralni prašek
English: These instructions show you how to prepare and give a dose of REYATAZ oral powder.
Slovenian: Naslednja navodila pojasnjujejo kako pripraviti in dati odmerek zdravila REYATAZ v obliki peroralnega praška.
English: Changes in the way your heart beats (heart rhythm change) may occasionally happen.
Slovenian: Občasno lahko pride do sprememb srčnega utripa (sprememba srčnega ritma).
English: Put the sachets' content in a small drinking cup.
Slovenian: Vsebino vrečic stresite v manjši kozarec.
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Slovenian: ANTAGONISTI ADRENERGIČNIH RECEPTORJEV ALFA-1 Alfuzosin
English: After mixing with food or beverage, mixture may be stored for up to 1 hour at temperatures not above 30°C.
Slovenian: Po mešanju s hrano ali z napitkom lahko mešanico shranite pri temperaturi do 30 °C za največ 1 uro.
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted)
Slovenian: Atazanavir, uporaba 1 uro po ddI+d4T (na tešče)
English: Some medicines may interact with ritonavir, a medicine that is taken with REYATAZ.
Slovenian: Nekatera zdravila lahko vplivajo na delovanje ritonavirja, zdravila, ki se jemlje skupaj z zdravilom REYATAZ.
English: HCV Protease Inhibitors
Slovenian: Zaviralci HCV proteaz
English: Food effect: co-administration of REYATAZ and ritonavir with food optimises the bioavailability of atazanavir.
Slovenian: Učinek hrane: pri uporabi zdravila REYATAZ in ritonavirja skupaj s hrano je biološka uporabnost atazanavirja optimalna.
English: Driving and using machines If you feel dizzy or lightheaded, do not drive or use machines, and contact your doctor immediately.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če občutite omotico ali vrtoglavico, ne vozite vozil ali upravljajte strojev in se takoj posvetujte z zdravnikom.
English: The efficacy of REYATAZ/ritonavir in combination with tenofovir disoproxil fumarate in treatmentexperienced patients has been demonstrated in clinical study 045 and in treatment naive patients in clinical study 138 (see sections 4.8 and 5.1).
Slovenian: Učinkovitost zdravila REYATAZ/ritonavirja v kombinaciji z dizoproksiltenofovirijevim fumaratom pri predhodno že zdravljenih bolnikih je bila dokazana v klinični študiji 045, pri predhodno še nezdravljenih bolnikih pa v klinični študiji 138 (glejte poglavji 4.8 in 5.1).
English: Do not use this medicine after the expiry date which is stated on the carton or sachet.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali vrečici.
English: REYATAZ + saquinavir was shown to be inferior to lopinavir + ritonavir.
Slovenian: Dokazano je bilo, da je kombinacija REYATAZ + sakvinavir slabša od kombinacije lopinavir + ritonavir.
English: Table 6: Efficacy Outcomes at Week 48a and at Week 96 (Study 045) Parameter
Slovenian: Preglednica 6: Izidi učinkovitosti v 48. tednua in 96. tednu (Študija 045) Parameter
English: Of the 60 isolates from patients treated with either atazanavir or atazanavir + ritonavir, 18 (30%) displayed the I50L phenotype previously described in naive patients.
Slovenian: Od 60 izolatov bolnikov, zdravljenih z atazanavirjem ali atazanavirjem + ritonavirjem, so pri 18 (30%) odkrili fenotip I50L, prej opisan pri predhodno protiretrovirusno nezdravljenih bolnikih.
English: If REYATAZ is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Slovenian: Če se zdravilo REYATAZ uporablja skupaj s parenteralnim midazolamom, ga je treba uporabljati v enoti za intenzivno nego ali podobnih okoliščinah, ki zagotavljajo skrben klinični nadzor in možnost ustreznega zdravniškega ukrepanja v primeru pojava zavore dihanja in/ali podaljšane sedacije.
English: The safety and efficacy of REYATAZ has not been established in patients with significant underlying liver disorders.
Slovenian: Varnost in učinkovitost zdravila REYATAZ nista raziskani pri bolnikih s pomembnimi osnovnimi boleznimi jeter.
English: Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Slovenian: Bolniki, sočasno okuženi z virusom hepatitisa B in/ali hepatitisa C Od 1.151 bolnikov, ki so prejemali atazanavir v odmerku 400 mg enkrat na dan, je 177 bolnikov sočasno imelo kronični hepatitis B ali C. Od 655 bolnikov, ki so prejemali atazanavir v odmerku 300 mg enkrat na dan skupaj z ritonavirjem v odmerku 100 mg enkrat na dan, je 97 bolnikov sočasno imelo kronični hepatitis B ali C. Pri sočasno okuženih bolnikih je verjetnost za izhodiščno zvišanje jetrnih transaminaz večja kot pri bolnikih brez kroničnega virusnega hepatitisa.
English: Renal impairment: in healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
Slovenian: Okvara ledvic: pri zdravih preiskovancih se je skozi ledvice izločilo v nespremenjeni obliki približno 7% uporabljenega odmerka atazanavirja.
English: Based on data obtained with other boosted PIs and ketoconazole, where ketoconazole AUC showed a 3-fold increase, REYATAZ/ritonavir is expected to increase ketoconazole or itraconazole concentrations.
Slovenian: Na osnovi podatkov, pridobljenih pri uporabi drugih okrepljenih zaviralcev proteaz in ketokonazola, kjer se je vrednost AUC ketokonazola povečala za 3-krat, pri uporabi zdravila REYATAZ/ritonavirja pričakujemo, da se bodo koncentracije ketokonazola ali itrakonazola povečale.
English: Do not take REYATAZ if you are allergic to atazanavir or any of the other ingredients of this medicine (listed in section 6) if you have moderate to severe liver problems.
Slovenian: Ne jemljite zdravila REYATAZ če ste alergični na atazanavir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).