FrancophonIA/ELRC3.0 huggingface dataset:
English: tenofovir disoproxil fumarate in treatment- experienced 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 atazanavirja/ritonavirja v kombinaciji z dizoproksiltenofovirjevim 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: Your doctor should do blood tests prior you start Atazanavir Krka and during treatment.
Slovenian: Zdravnik mora pred začetkom zdravljenja z zdravilom Atazanavir Krka in med zdravljenjem opravljati krvne preiskave.
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.
Slovenian: Zdravilo Atazanavir Krka 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: Each hard capsule contains 105.91 mg lactose monohydrate.
Slovenian: Ena trda kapsula vsebuje 105,91 mg laktoze monohidrata.
English: Sildenafil, tadalafil and vardenafil are metabolised by CYP3A4.
Slovenian: Sildenafil, tadalafil in vardenafil se presnavljajo s CYP3A4.
English: bSee description of selected adverse reactions for more details.
Slovenian: b Za več podrobnosti glejte Opis izbranih neželenih učinkov v nadaljevanju.
English: 300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil.
Slovenian: 300 mg dizoproksiltenofovirjevega fumarata ustreza 245 mg dizoproksiltenofovirata.
English: 30 hard capsules: EU/1/19/1353/003 90 (3 x 30) hard capsules: EU/1/19/1353/004
Slovenian: 30 trdih kapsul: EU/1/19/1353/003 90 (3 x 30) trdih kapsul: EU/1/19/1353/004
English: In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), Atazanavir Krka should be used with caution and only if the benefits exceed the risk (see section 5.1).
Slovenian: Pri bolnikih z obstoječimi motnjami prevajanja (atrioventrikularni blok druge ali višje stopnje ali kompleksni kračni blok) je treba zdravilo Atazanavir Krka uporabljati previdno in le, če korist odtehta tveganje (glejte poglavje 5.1).
English: Due to phenytoin/phenobarbital inducing effect, a reduction in atazanavir exposure cannot be ruled out.
Slovenian: Zaradi inducirajočega učinka fenitoina/fenobarbitala zmanjšanja izpostavljenosti atazanavirju ne moremo izključiti.
English: Buprenorphine AUC ↑67% Buprenorphine cmax ↑37% Buprenorphine cmin ↑69%
Slovenian: Buprenorfin AUC ↑67 % Buprenorfin Cmax ↑37 % Buprenorfin Cmin ↑69 %
English: * In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28).
Slovenian: * V kombinirani analizi so atazanavir 300 mg in ritonavir 100 mg (n = 33) primerjali z atazanavirjem 400 mg brez ritonavirja (n = 28).
English: Body: titanium dioxide (E171) and gelatine
Slovenian: Telo: titanov dioksid (E171) in želatina
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,
English: If the use of atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful safety monitoring (see section 4.4).
Slovenian: Če je uporaba atorvastatina nujno potrebna, je treba uporabiti najmanjši možni odmerek atorvastatina in natančno spremljati varnost
English: Calcium channel blockers Bepridil
Slovenian: Zaviralci kalcijevih kanalčkov
English: The potential for PR prolongation should be considered in cases of overdose (see section
Slovenian: V primerih prevelikega odmerjanja je treba upoštevati možnost podaljšanja intervala PR (glejte poglavje 4.9).
English: 150 mg hard capsules: 60 hard capsules: EU/1/19/1353/001
Slovenian: 150 mg trde kapsule: 60 trdih kapsul: EU/1/19/1353/001
English: When Atazanavir Krka and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
Slovenian: Pri sočasni uporabi zdravila Atazanavir Krka in ritonavirja lahko prevladajo presnovne interakcijske značilnosti ritonavirja, saj je ritonavir močnejši zaviralec CYP3A4 kot atazanavir.
English: The content of the capsule is yellowishwhite to yellow-white powder.
Slovenian: Vsebina kapsule je rumenkasto bel do rumeno bel prašek.
English: The body and the cap of the capsule are brownish-orange colour.
Slovenian: Telo in kapica kapsule sta rjavkasto oranžne barve.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING CONTAINER LABEL
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA VSEBNIKU
English: There are other medicines that may not mix with Atazanavir Krka.
Slovenian: So tudi druga zdravila, ki jih ne smete jemati v kombinaciji z zdravilom Atazanavir Krka.
English: Co-administration of alfuzosin concentrations which can result in hypotension.
Slovenian: Tveganje za porast koncentracij alfuzosina in posledičen pojav hipotenzije.
English: Concomitant use of salmeterol and Atazanavir Krka may result in increased cardiovascular adverse events associated with salmeterol.
Slovenian: Pri sočasni uporabi salmeterola in zdravila Atazanavir Krka se lahko poveča pojavnost kardiovaskularnih neželenih učinkov salmeterola.
English: Co-administration of Atazanavir Krka with these medicinal products is expected to substantially increase their concentrations and may result in PDE5associated adverse reactions such as hypotension, visual changes and priapism (see section 4.5).
Slovenian: Pri sočasni uporabi zdravila Atazanavir Krka in teh zdravil pričakujemo znaten porast njihovih koncentracij, kar posledično lahko privede do pojava neželenih učinkov zaviralcev PDE5, kot so hipotenzija, spremembe vida in priapizem (glejte poglavje 4.5).
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.
Slovenian: Pri bolnikih, okuženih z virusom HIV (n = 13), je pri ponavljajočih se odmerkih atazanavirja v odmerku 400 mg (brez ritonavirja) enkrat na dan skupaj s hrano geometrijska srednja vrednost Cmax (KV %) atazanavirja znašala 2.298 (71) ng/ml, vrednost Cmax pa je bila dosežena približno po 2,0 urah.
English: In clinical trials of antiretroviral treatment naive patients treated with unboosted atazanavir, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
Slovenian: V kliničnih preskušanjih pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, je bila pri zdravljenju z atazanavirjem brez okrepitve farmakokinetike substitucija I50L, včasih v kombinaciji s spremembo A71V, značilna substitucija za odpornost proti atazanavirju.
English: De novo substitutions in treatment experienced patients failing therapy with atazanavir + ritonavir (Study 045, 48 weeks)
Slovenian: Preglednica 4: Pojav novih substitucij pri predhodno že zdravljenih bolnikih po neuspešnem zdravljenju z atazanavirjem + ritonavirjem (študija 045, 48 tednov) Pogostnost
English: Concomitant use of Atazanavir Krka /ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Slovenian: Sočasne uporabe zdravila Atazanavir Krka/ritonavirja in flutikazona ali drugih glukokortikoidov, ki se presnavljajo s CYP3A4, ne priporočamo, razen če možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo (glejte poglavje 4.5).
English: Treatment of overdose with Atazanavir Krka should consist of general supportive measures, including monitoring of vital signs and electrocardiogram (ECG), and observations of the patient's clinical status.
Slovenian: vključno z nadzorom vitalnih znakov in elektrokardiogramom (EKG) ter opazovanje bolnikovega kliničnega stanja.
English: Co-administration of lamotrigine and atazanavir /ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Slovenian: Pri sočasni uporabi lamotrigina in atazanavirja/ritonavirja se zaradi indukcije UGT1A4 lahko zmanjšajo koncentracije lamotrigina v plazmi.
English: Atazanavir Krka 300 mg hard capsules are available in containers containing 30 hard capsules or 90 (3 x 30) hard capsules; in a box.
Slovenian: Zdravilo Atazanavir Krka 300 mg je na voljo v vsebnikih po 30 trdih kapsul ali 90 (3 x 30) trdih kapsul; v škatli.
English: The M184I/V substitution emerged in 5/26 atazanavir /ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Slovenian: Substitucija M184I/V se je pri zdravljenju z atazanavirjem/ritonavirjem pojavila pri 5/26 bolnikov z virusnim neodzivom, pri zdravljenju z lopinavirjem/ritonavirjem pa pri 7/26 bolnikov z virusnim neodzivom.
English: 1157 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
Slovenian: 1.157 celic/mm3), srednja plazemska vrednost HIV-1 RNA pa 4,09 log10 kopij/ml (razpon: 3,28 do 5,00 log10 kopij/ml).
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.
Slovenian: Sočasna uporaba vorikonazola in zdravila Atazanavir Krka z ritonavirjem ni priporočljiva, razen če ocena koristi/tveganj opraviči uporabo vorikonazola.
English: In clinical trial AI424-182 atazanavir /ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
Slovenian: V kliničnem preskušanju AI424-182 je 41 nosečnic med drugim in tretjim trimesečjem nosečnosti prejemalo atazanavir/ritonavir (300/100 mg ali 400/100 mg) v kombinaciji z zidovudinom/lamivudinom.
English: Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
Slovenian: Itrakonazol je podobno kot ketokonazol močan zaviralec in tudi substrat za
English: Your doctor may adjust the dose of Atazanavir Krka according to your anti-HIV therapy.
Slovenian: Zdravnik bo točno odredil vaš odmerek zdravila Atazanavir Krka glede na druga zdravila proti HIV.
English: 14-OH clarithromycin cmax ↓72% 14-OH clarithromycin cmin ↓62%
Slovenian: 14-OH klaritromicin Cmax ↓72 % (↓76 % 14-OH klaritromicin Cmin ↓62 % (↓66 %
English: 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
English: What Atazanavir Krka contains - The active substance is atazanavir.
Slovenian: Kaj vsebuje zdravilo Atazanavir Krka - Učinkovina je atazanavir.
English: Raltegravir AUC ↑41% Raltegravir cmax ↑24% Raltegravir c12hr ↑77% The mechanism is UGT1A1 inhibition.
Slovenian: Raltegravir AUC ↑41 % Raltegravir Cmax ↑24 % Raltegravir C12hr ↑77 %
English: De novo substitutions in treatment naive patients failing therapy with atazanavir + ritonavir (Study 138, 96 weeks)
Slovenian: Preglednica 3: Pojav novih substitucij pri predhodno še nezdravljenih bolnikih po neuspešnem zdravljenju z atazanavirjem + ritonavirjem (študija 138, 96 tednov) Pogostnost
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.
Slovenian: Pri treh od 20 dojenčkov (15 %) katerih matere so se zdravile z atazanavirjem/ritonavirjem v odmerku 300/100 mg in pri štirih od 20 dojenčkov (20 %), ki so se rodili materam, ki so se zdravile z atazanavirjem/ritonavirjem v odmerku 400/100 mg, so poročali o vrednosti bilirubina stopnje 3-4.
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).
Slovenian: Študija 138 je mednarodno, randomizirano, odprto, multicentrično, prospektivno preskušanje, ki je pri predhodno še nezdravljenih bolnikih primerjalo uporabo atazanavirja/ritonavirja (300 mg/100 mg enkrat na dan) z uporabo lopinavirja/ritonavirja (400 mg/100 mg dvakrat na dan), oboje v kombinaciji s fiksnimi odmerki dizoproksiltenofovirjevega fumarata/emtricitabina (300 mg/200 mg tablete enkrat na dan).
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Slovenian: Poročajo, da se med imunsko reaktivacijo lahko pojavijo tudi avtoimunske bolezni (kot je Gravesova bolezen); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja.
English: In a clinical study AI424-020, paediatric patients 3 months to less than 18 years of age who received either the oral powder or capsule formulation had a mean duration of treatment with atazanavir of 115 weeks.
Slovenian: V klinični študiji AI424-020 je zdravljenje pediatričnih bolnikov, starih od 3 mesecev do manj kot 18 let, z atazanavirjem v obliki peroralnega praška ali kapsul v povprečju trajalo 115 tednov.
English: ≥ 200 cells/mm
Slovenian: ≥ 200 celic/mm3
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. Coinfected 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
English: When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir disoproxil, atazanavir concentrations are expected to be additionally decreased by about
Slovenian: Pri uporabi atazanavirja v odmerku 300 mg in ritonavirja v odmerku 100 mg brez dizoproksiltenofovirjevega fumarata pa pričakujemo, da se bodo koncentracije atazanavirja še dodatno zmanjšale za približno 20%.
English: It is especially important to mention these: - other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz) - boceprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C) - sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction)) - if you are taking an oral contraceptive ("the Pill") with Atazanavir Krka to prevent pregnancy,
Slovenian: Posebno pomembno je omeniti naslednje: - druga zdravila za zdravljenje okužbe z virusom HIV (npr. indinavir, nevirapin in efavirenz), - boceprevir (zdravilo za zdravljenje hepatitisa C), - sildenafil, vardenafil ali tadalafil (zdravila za zdravljenje moške impotence (erektilna disfunkcija)),
English: If you take more Atazanavir Krka than you should Yellowing of the skin and/or eyes (jaundice) and irregular heart beat (QTc prolongation) may occur if you or your child take too much Atazanavir Krka.
Slovenian: Če ste vzeli večji odmerek zdravila Atazanavir Krka, kot bi smeli Če ste vzeli ali je otrok vzel prevelik odmerek zdravila Atazanavir Krka, se lahko pojavi rumeno obarvanje kože in/ali očesnih beločnic (zlatenica) in nepravilen srčni utrip (podaljšanje intervala QTc).
English: ACID REDUCING AGENTS
Slovenian: ZDRAVILA ZA ZMANJŠEVANJE KISLOSTI ŽELODČNEGA SOKA
English: Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Slovenian: Dva odstotka bolnikov, ki so prejemali atazanavir, sta imela sočasno zvišanje ALT/AST 3. oz. 4.
English: Overall in this study, 182 paediatric patients (81 antiretroviral-naive and 101 antiretroviral-experienced) received once daily atazanavir (capsule or powder formulation), with or without ritonavir, in combination with two NRTIs.
Slovenian: (81 jih še ni prejemalo protiretrovirusnih zdravil, 101 bolnik pa je protiretrovirusna zdravila že jemal) prejemalo atazanavir enkrat na dan (v obliki kapsul ali praška), z ritonavirjem ali brez njega, v kombinaciji z dvema NRTI-jema.
English: For treatmentexperienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm3 (range: 100 to
Slovenian: Pri bolnikih, ki so predhodno že prejemali tovrstno zdravljenje, je bilo v izhodišču srednje število celic CD4 522 celic/mm3 (razpon: 100 do
English: Do not take sildenafil with Atazanavir Krka when sildenafil is used for the treatment of pulmonary arterial hypertension.
Slovenian: Med zdravljenjem z zdravilom Atazanavir Krka ne smete uporabljati sildenafila za zdravljenje pljučne arterijske hipertenzije.
English: Atazanavir Krka 150 mg hard capsules Atazanavir Krka 200 mg hard capsules Atazanavir Krka 300 mg hard capsules atazanavir
Slovenian: Atazanavir Krka 150 mg trde kapsule Atazanavir Krka 200 mg trde kapsule Atazanavir Krka 300 mg trde kapsule
English: Electrocardiographic changes (sinus bradycardia, prolongation of PR interval, prolongation of QT interval, and prolongation of QRS complex) were observed only in an initial 2 week oral toxicity study performed in dogs.
Slovenian: Elektrokardiografske spremembe (sinusna bradikardija, podaljšanje intervala PR, intervala QT in razširitev kompleksa
English: Co-administration with atazanavir may cause a large increase in the concentration of these benzodiazepines.
Slovenian: Pri sočasni uporabi atazanavirja se lahko koncentracije teh benzodiazepinov močno povečajo.
English: PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving Atazanavir Krka.
Slovenian: Uporaba zaviralcev PDE5 za zdravljenje erektilne disfunkcije: pri bolnikih, ki se zdravijo z zdravilom Atazanavir Krka, je potrebna posebna previdnost pri predpisovanju zaviralcev PDE5 (sildenafil,
English: The geometric mean (CV%) for atazanavir cmin and AUC was 654 (76%) ng/ml and 44185 (51%) ng•h/ml, respectively.
Slovenian: Geometrijska srednja vrednost Cmin (KV %) atazanavirja je bila 654 (76 %) ng/ml, geometrijska srednja vrednost AUC (KV %) atazanavirja pa 44.185 (51 %) ng•h/ml.
English: At baseline, 34% of patients were receiving a PI and 60% were receiving an NNRTI.
Slovenian: Izhodiščno je 34 % bolnikov dobivalo zaviralce proteaz in 60 % NNRTI-je.
English: Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristic d
Slovenian: 48. teden: -3 % [-7,6 %, 1,5 %] 96. teden: 2,2 % [-2,3 %, 6,7 %]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1353/001
English: LIST OF EXCIPIENTS Contains also lactose monohydrate.
Slovenian: Vsebuje tudi laktozo monohidrat.
English: The capsule cap is imprinted with black mark A150.
Slovenian: Na kapici kapsule je odtisnjena črna oznaka A150.
English: If you stop taking Atazanavir Krka Do not stop taking Atazanavir Krka before talking to your doctor.
Slovenian: Zdravila Atazanavir Krka ne smete prenehati jemati, dokler se ne posvetujete z zdravnikom.
English: Coadministration of diltiazem and atazanavir /ritonavir has not been studied.
Slovenian: Sočasne uporabe diltiazema in atazanavirja/ritonavirja niso raziskovali.
English: Atazanavir (am): 2 hr after omeprazole
Slovenian: Atazanavir (dopoldan): 2 uri po omeprazolu
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: 33 %; srednji čas Tmax se je podaljšal iz 2,0 na 5,0 ur.
English: If you forget to take Atazanavir Krka
Slovenian: Če ste pozabili vzeti zdravilo Atazanavir Krka
English: The geometric mean (CV%) for atazanavir cmin and AUC were 120 (109) ng/ml and 14874 (91) ng•h/ml, respectively.
Slovenian: Geometrijska srednja vrednost Cmin (KV %) atazanavirja je znašala 120 (109) ng/ml, geometrijska srednja vrednost AUC (KV %) atazanavirja pa 14.874 (91) ng•h/ml.
English: Method of administration For oral use.
Slovenian: Način uporabe Peroralna uporaba.
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%).
Slovenian: Pri bolnikih, ki so prejemali atazanavir v odmerku 400 mg enkrat na dan ali atazanavir v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg enkrat na dan, so bili kot zelo pogosti opisani le naslednji neželeni učinki vseh jakosti, ki bi vsaj lahko bili povezani z uporabo atazanavirja v kombinaciji z enim NRTI-jem ali več NRTI-ji: slabost (20 %), driska (10 %) in zlatenica (13 %).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1353/002
English: Voriconazole AUC ↑561% Voriconazole cmax ↑438% (↑355% Voriconazole cmin ↑765% (↑571%
Slovenian: Vorikonazol AUC ↑561 % (↑451 % Vorikonazol Cmax ↑438 % (↑355 % Vorikonazol Cmin ↑765 % (↑571 %
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).
Slovenian: Sočasne uporabe atazanavirja/ritonavirja in teh glukokortikoidov ne priporočamo, razen če možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov (glejte poglavje 4.4).
English: Protease inhibitors: The co-administration of atazanavir /ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
Slovenian: Zaviralci proteaz: Sočasne uporabe atazanavirja/ritonavirja in drugih zaviralcev proteaz niso raziskovali.
English: H2-Receptor antagonists Without Tenofovir disoproxil In HIV-infected patients with atazanavir/ritonavir at the recommended dose 300/100 mg once daily
Slovenian: Brez dizoproksiltenofovirata Pri z virusom HIV okuženih bolnikih, ki so se zdravili z atazanavirjem/ritonavirjem v priporočenem odmerku 300/100 mg enkrat na dan
English: Co-administration of a single 300 mg dose of atazanavir and 100 mg dose of ritonavir with a light meal resulted in a 33% increase in the AUC and a 40% increase in both the cmax and the 24 hour concentration of atazanavir relative to the fasting state.
Slovenian: V primerjavi z uporabo na tešče so se pri uporabi enkratnega 300 mg odmerka atazanavirja in 100 mg odmerka ritonavirja skupaj z lahkim obrokom vrednosti AUC, Cmax in 24-urne koncentracije atazanavirja povečale, in sicer AUC za 33 %, Cmax in 24-urna koncentracija pa za 40 %.