natgillin/translations-raw huggingface dataset:
The prescriber should advise the patient to scoop an overfilled spoon of loose powder from the bottle using the measuring spoon provided.
Zdravnik mora bolniku svetovati, naj iz plastenke s priloženo merilno žličko zajame zvrhano žličko praška.
The patient should then gently level the powder in the spoon by scraping the extra powder back into the bottle using a flat edge of a knife or spatula.
Bolnik mora nato previdno zravnati prašek na žlički, tako da odvečni prašek ostrga nazaj v plastenko s topim robom noža ali lopatico.
Patients should be advised not to pack the powder into the spoon or to attempt to level the powder by shaking or tapping the spoon.
Bolnikom je treba povedati, da praška na žlički ne smejo zravnavati s tlačenjem praška ali s tresenjem ali trkanjem po žlički.
The oral powder may be mixed with water, milk, applesauce or yoghurt.
Peroralni prašek se lahko zmeša z vodo, mlekom, čežano ali jogurtom.
Once the oral powder is mixed with these, it should be used within 6 hours.
Ko je peroralni prašek zmešan z enim od teh, ga je treba uporabiti v 6 urah.
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex
Pri bolnikih z obstoječimi motnjami prevajanja (atrioventrikularni blok
83 bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk (see section 5.1).
87 druge ali višje stopnje ali kompleksni kračni blok) je treba zdravilo REYATAZ uporabljati previdno in le, če korist odtehta tveganje (glejte poglavje 5. 1).
This should be taken into account in patients with diabetes mellitus.
Diabetiki Peroralni prašek REYATAZ vsebuje 7, 3 g saharoze v 300 mg dnevnem odmerku, kar je treba upoštevati pri bolnikih s sladkorno boleznijo.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/ galaktoze ali pomanjkanjem saharoza- izomaltaze ne smejo jemati tega zdravila.
The long-term consequences of these reactions are currently unknown.
Dolgotrajne posledice teh učinkov za zdaj niso znane.
84 Indinavir is also associated with indirect (unconjugated) hyperbilirubinaemia due to inhibition of UGT.
Tudi indinavir je povezan z zvišanjem indirektnega (nekonjugiranega) bilirubina v krvi zaradi zavrtja UGT.
Nephrolithiasis Nephrolithiasis has been reported in patients receiving REYATAZ (see section 4.8).
88 Nefrolitiaza Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, so poročali o pojavu nefrolitiaze (glejte poglavje 4. 8).
85 REYATAZ oral powder contains aspartame as a sweetening agent.
89 Peroralni prašek REYATAZ kot sladilo vsebuje aspartam.
Aspartame provides a source of phenylalanine and, therefore, may not be suitable for persons with phenylketonuria.
Aspartam je vir fenilalanina in lahko škoduje ljudem s fenilketonurijo.
Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Zato je kontraindicirana uporaba kombinacije zdravila REYATAZ in ritonavirja z zdravili, ki so substrati za CYP3A4 in imajo ozek terapevtski indeks, npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralne oblike midazolama in alkaloidi ergot, zlasti ergotamin in dihidroergotamin (glejte poglavje 4. 3).
Other interactions Interactions between atazanavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ BID” and once daily as “ QD”).
Druge interakcije V spodnji tabeli so navedene interakcije med atazanavirjem/ ritonavirjem in zaviralci proteaz, drugimi protiretrovirusnimi zdravili ter drugimi neprotiretrovirusnimi zdravili (zvišanje je navedeno kot “ ↑ ”, znižanje kot “ ↓ ”, brez spremembe kot “ ↔ ”, dvakrat na dan kot “ 2x/ dan ” in enkrat na dan kot “ 1x/ dan ”).
booster of atazanavir pharmacokinetics.
uporablja kot stopnjevalec farmakokinetike
Based on these data
reverzne transkriptaze (NRTI- ji)
zidovudine 300 mg BID (atazanavir 400 mg QD)
Na osnovi teh podatkov in ker
No significant effect on lamivudine and zidovudine concentrations observed.
Pomembnih vplivov na koncentracije lamivudina in zidovudina niso (atazanavir 400 mg 1x/ dan)
Abacavir
opazili.
The co-administration of REYATAZ/ ritonavir with abacavir is not expected to significantly alter the exposure of abacavir.
pomembnejšega vpliva ritonavirja na farmakokinetiko NRTI- jev ne pričakujemo, pri sočasni uporabi zdravila REYATAZ / ritonavirja s temi zdravili ne pričakujemo, da bi se izpostavljenost sočasno uporabljenim zdravilom
Medicinal AUC Cmax
Vrednoteno
co-administration
pomembneje spremenila.
REYATAZ/ ritonavir
sočasna uporaba z
taken with food.
skupaj s hrano.
The
Pri
co-administration of
(0, 08; 0, 21) (0, 06; 0, 18) (0, 10; 0, 27) ddI+d4T (na tešče) atazanavir,
1 hr after ddI+d4T
↔ 1, 03 ↑ 1, 12 ↔ 1, 03 uporaba 1 uro po
(0.64, 1.67)
stavudinom
(0.67, 1.18)
(0, 64; 1, 67) (0, 67; 1, 18) (0, 61; 1, 73) ddI+d4T (na tešče)
(0.61, 1.73)
pomembnejših sprememb v
Atazanavir concentrations were greatly decreased when co-administered with didanosine (buffered tablets) and stavudine.
Pri sočasni uporabi z didanozinom (pufrane tablete) in s stavudinom so se izpostavljenosti koncentracije atazanavirja močno zmanjšale.
Tenofovir disoproxil fumarate 300 mg QD (atazanavir 300
300 mg 1x/ dan (atazanavir
Patients should be closely monitored for
nadzirati glede pojava
(atazanavir 400 mg QD with ritonavir 100 mg QD) study
ritonavirjem 100 mg 1x/ dan)
(1.17, 1.36) ↓ 0.81*
0, 81 *
(1.11, 1.32) ↔ 1.02*
↔ 1, 02 *
(1.25, 1.47) ↓ 0.41*
0, 41 *
nevirapine with REYATAZ/ ritonavir is
REYATAZ / ritonavirja
section 4.4)
Vrednoteno
87
AUC
Co-administered medicinal products (dose in mg)
zdravila (odmerek v mg)
Medicinal AUC Cmax Cmin product assessed (90% CI) (90% CI) (90% CI)
(90% IZ) (90% IZ) (90% IZ)
Recommendations concerning co-administration
sočasno uporabo
↑ 1.94
↑ 1, 94
↑ 1.50
↑ 1, 50
↑ 2.60
↑ 2, 60
(1.75, 2.16)
(1, 75; 2, 16)
(1.32, 1.71)
(1, 32; 1, 71)
(2.35, 2.88)
(2, 35; 2, 88)
regarding dose reduction can be made;
Če se
↓ 0.30
↓ 0, 30
↓ 0.28
↓ 0, 28
↓ 0.38
↓ 0, 38
clarithromycin
zdravilo REYATAZ /
therefore, caution
klaritromicin
(0.26, 0.34)
(0, 26; 0, 34)
(0.24, 0.33)
(0, 24; 0, 33)
(0.34, 0.42)
(0, 34; 0, 42)
should be exercised if
ritonavir uporablja skupaj s
↑ 1.28
↑ 1, 28
↔ 1.06
↔ 1, 06
↑ 1.91
↑ 1, 91
REYATAZ/ ritonavir is co-administered with
klaritromicinom, je
(1.16, 1.43)
(1, 16; 1, 43)
(0.93, 1.20)
(0, 93; 1, 20)
(1.66, 2.21)
(1, 66; 2, 21)
The mechanism of the clarithromycin/ atazanavir interaction is CYP3A4 inhibition.
potrebna previdnost.
clarithromycin.
Mehanizem interakcije klaritromicin/ atazanavir je indukcija CYP3A4.
Ketoconazole 200 mg QD (atazanavir 400 mg QD)
Zdravila za zdravljenje glivičnih okužb Ketokonazol 200 mg 1x/ dan (atazanavir 400 mg 1x/ dan)
Ketoconazole and itraconazole should be used cautiously with
Ketokonazol in itrakonazol je treba uporabljati previdno skupaj z zdravilom
REYATAZ/ ritonavir.
REYATAZ / ritonavirjem.
↑ 1.15 ↑ 1.34 ↑ 1.13
(atazanavir 400 mg 1x/ dan) atazanavir
No dose adjustment is needed for REYATAZ/ ritonavir.
odmerek atazanavirja.
Rifampicin ACID REDUCING AGENTS H2-Receptor antagonists
* Pri primerjavi z rifabutinom 300 mg 1x/ dan. teden).
Rifampicin is a strong CYP3A4 inducer and has been shown to cause a 72% decrease in atazanavir AUC which can result in virological failure and resistance development.
Posledica tega je lahko upad protivirusnega delovanja in razvoj rezistence.
The combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Sočasna uporaba rifampicina in zdravila REYATAZ skupaj z nizkim odmerkom ritonavirja je kontraindicirana (glejte poglavje 4. 3).
Famotidine 40 mg BID
atazanavir
atazanavir ↓ 0.82 ↓ 0.86 ↓ 0.72
↓ 0, 86
No dosage adjustment
Pri sočasni uporabi
co-administration
Sočasne uporabe
(atazanavir 300 mg QD with
(atazanavir 400 mg 1x/ dan z
(0.75, 0.89)
(dopoldan):
(0.79, 0.94)
(0, 35; 0, 45)
(0.64, 0.81)
(0, 38; 0, 51)
of REYATAZ/
(0, 29; 0, 41)
ritonavir 100 mg QD) Proton pump inhibitors
Če je
Although not studied, similar results are expected with other H2-receptor antagonists.
atazanavir
ritonavir is required when co-administered with an H2-receptor antagonist, all as a single daily dose with food.
uporaba zdravila
Omeprazole 40 mg QD
(atazanavir 400 mg 1x/ dan z
2
↓ 0, 70 *
Co-administration of
↓ 0, 69 *
(atazanavir 400 mg QD with
↓ 0, 69 *
0.39 0.44 0.35 hr after
1 uro
REYATAZ/ ritonavir
REYATAZ / ritonavirja
(0.35, 0.45) (0.38, 0.51) (0.29, 0.41) omeprazole
(0, 57; 0, 86)
with proton pump inhibitors is not recommended.
(0, 58; 0, 83)
If the
(0, 54; 0, 88)
Omeprazole 20 mg QD (atazanavir 400 mg QD with ritonavir 100 mg QD)
z zaviralcem protonske črpalke nujna, je
atazanavir (am):
(glejte poglavje 4. 4).
1 ↓ 0.70* ↓ 0.69* ↓ 0.69* hr after (0.57, 0.86) (0.58, 0.83) (0.54, 0.88) omeprazaole * When compared to atazanavir 300 mg QD with ritonavir 100 mg QD
Antacidi Antacidi in zdravila, ki vsebujejo pufre ANTIKOAGULANTI
combination of REYATAZ/ ritonavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is
Zdravilo REYATAZ / ritonavir je treba uporabljati 2 uri pred ali 1 uro po uporabi antacida ali zdravila, ki vsebuje pufer.
Antacids
Varfarin
The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of REYATAZ/ ritonavir (400/ 100 mg once daily) was temporally separated from omeprazole by 12 hours.
Pri sočasni uporabi zdravila REYATAZ / ritonavirja se lahko vrednost INR (internacionalno normalizirano razmerje) zmanjša, v redkejših primerih pa tudi poveča.
Although not studied, similar results are expected with other proton pump inhibitors.
Med zdravljenjem z zdravilom REYATAZ / ritonavirjem priporočamo skrben nadzor vrednosti INR, še posebej ob uvedbi zdravljenja.
This decrease in atazanavir exposure might negatively impact the efficacy of atazanavir.
ZDRAVILA Z DELOVANJEM NA NOVOTVORBE IN IMUNOSUPRESIVI Zdravila z delovanjem na novotvorbe Irinotekan Imunosupresivi
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Atazanavir zavira UGT in lahko vpliva na presnovo irinotekana, pri čemer toksičnost irinotekana lahko poveča.
recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Če se zdravilo REYATAZ / ritonavir uporablja skupaj z irinotekanom, je bolnika treba skrbno nadzirati glede pojava neželenih učinkov irinotekana.
Antacids and medicinal products containing buffers ANTICOAGULANTS
Ciklosporin Takrolimus Sirolimus
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with REYATAZ/ ritonavir.
Pri sočasni uporabi z zdravilom REYATAZ / ritonavirjem se zaradi zavrtja CYP3A4 lahko koncentracije teh imunosupresivov lahko povečajo.
REYATAZ/ ritonavir should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Priporočamo pogostejše spremljanje terapevtskih koncentracij teh zdravil, dokler se plazemske vrednosti ne ustalijo.
Warfarin
IN OŽILJA
Co-administration with REYATAZ/ ritonavir has the potential to produce a decrease or, less often, an increase in INR (International Normalised Ratio).
Amiodaron, Lidokain za sistemsko uporabo,
It is recommended that the INR be monitored carefully during treatment with REYATAZ/ ritonavir, especially when commencing therapy.
Pri sočasni uporabi z zdravilom REYATAZ / ritonavirjem se lahko koncentracije teh antiaritmikov povečajo.
ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics Irinotecan
Mehanizem interakcije med amiodaronom in sistemskim lidokainom ter atazanavirjem je zavrtje
Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.
Priporočamo nadziranje terapevtskih
If REYATAZ/ ritonavir is co-administered with irinotecan, patients should be closely
94
89 Co-administered medicinal
Sočasno uporabljena
co-administration
Kinidin Zaviralci kalcijevih kanalčkov
monitored for adverse events related to irinotecan.
CYP3A4.
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ/ ritonavir due to CYP3A4 inhibition.
Kinidin ima ozko terapevtsko okno, njegova uporaba pa je kontraindicirana zaradi možne inhibicije CYP3A z zdravilom REYATAZ / ritonavirjem.
Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ/ ritonavir.
koncentracij, če je to mogoče.
↑ 2.25 ↑ 1.98 ↑ 2.42 diltiazem
↑ 2, 25 ↑ 1, 98 ↑ 2, 42 diltiazem
(2.09, 2.41 (1.78, 2.19) (2.14, 2.73) desacetyl- ↑ 2.65 ↑ 2.72 ↑ 2.21 diltiazem (2.45, 2.87) (2.44, 3.03) (2.02, 2.42)
(2, 09; 2, 41 (1, 78; 2, 19) (2, 14; 2, 73) ↑ 2, 65 ↑ 2, 72 ↑ 2, 21 desacetil- diltiazem (2, 45; 2, 87) (2, 44; 3, 03) (2, 02; 2, 42) Pomembnih učinkov na koncentracije atazanavirja niso opazili.
The mechanism of diltiazem/ atazanavir interaction is CYP3A4 inhibition.
Mehanizem interakcije diltiazem/ atazanavir je inhibicija CYP3A4.
needed and ECG monitoring.
zmanjšanje odmerka diltiazema za 50% ter kasnejše povečevanje odmerka v skladu s spremljanjem EKG.
Verapamil CORTICOSTEROIDS
Verapamil KORTIKOSTEROIDI
Serum concentrations of verapamil may be increased by REYATAZ/ ritonavir due to CYP3A4 inhibition.
Pri sočasni uporabi z zdravilom REYATAZ / ritonavirjem se lahko serumske koncentracije verapamila povečajo zaradi inhibicije CYP3A4..
Caution should be exercised when verapamil is co-administered with REYATAZ/ ritonavir.
Pri sočasni uporabi zdravila REYATAZ / ritonavirja in verapamila je potrebna previdnost.
Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules BID)
Flutikazonpropionat za intranazalno uporabo 50 µg 4 krat na dan, 7 dni (ritonavir 100 mg kapsule 2x/ dan)
Co-administration of REYATAZ/ ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Sočasne uporabe zdravila REYATAZ / ritonavirja in teh glukokortikoidov ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov (glejte poglavje 4. 4).
90
95
ERECTILE DYSUNCTION PDE5 Inhibitors Sildenafil
ZDRAVILA ZA ZDRAVLJENJE EREKTILNE DISFUNKCIJE Zaviralci PDE5 Sildenafil
John's wort with REYATAZ/ ritonavir may be expected to result in significant reduction in plasma levels of atazanavir.
Pri sočasni uporabi šentjanževke in zdravila REYATAZ/ ritonavirja lahko pričakujemo pomembno zmanjšanje plazemskih vrednosti atazanavirja.
There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
Obstaja tveganje za izgubo terapevtskega učinka in razvoj odpornosti (glejte poglavje 4. 3).
John's wort is contraindicated.
Sočasna uporaba zdravila REYATAZ/ ritonavirja in pripravkov s šentjanževko je kontraindicirana.
HORMONAL CONTRACEPTIVES Ethinyloestradiol 35 μ g + norethindrone (atazanavir 400
Etinilestradiol 35 μg + noretindron (atazanavir 400 mg 1x/ dan)
mg QD) LIPID LOWERING AGENTS HMG-CoA reductase inhibitors
Sočasni uporabi zdravila REYATAZ/ ritonavirja
Co-administration of simvastatin or lovastatin with REYATAZ/ ritonavir is not recommended due to an increased risk of myopathy including rhabdomyolysis.
Sočasna uporaba simvastatina ali lovastatina z zdravilom REYATAZ / ritonavirjem ni priporočljiva zaradi večjega tveganja za pojav miopatije, vključno z rabdomiolizo.
buprenorphine ↑ 1.67 ↑ 1.37 ↑ 1.69
↑ 1, 69
norbuprenorphine ↑ 2.05 ↑ 1.61 ↑ 2.01 The mechanism of interaction is CYP3A4 and UGT1A1 inhibition.
Odmerek
Concentrations of atazanavir were not significantly affected.
Mehanizem interakcije je zaviranje CYP3A4 in UGT1A1.
clinical monitoring for sedation and cognitive effects.
Koncentracije atazanavirja se niso pomembneje spremenile.
A dose reduction of buprenorphine may be considered
buprenorfina bo morda treba zmanjšati.
Methadone, stable maintenance dose (atazanavir 400 mg QD)
Metadon, stabilni vzdrževalni odmerek (atazanavir 400 mg 1x/ dan)
Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is
Glede na to, da je bilo dokazano, da nizki odmerek ritonavirja (100 mg dvakrat na dan) nima pomembnega vpliva na koncentracije metadona, na osnovi teh podatkov pri sočasni uporabi metadona, zdravila REYATAZ in ritonavirja interakcij ne pričakujemo.
No dosage adjustment is necessary if methadone is
Pri sočasni uporabi metadona, zdravila REYATAZ in ritonavirja odmerkov ni treba prilagajati.
91
96
Midazolam Triazolam
SEDATIVI Benzodiazepini Midazolam Triazolam
REYATAZ/ ritonavir should not be co-administered with triazolam or orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of REYATAZ/ ritonavir and parenteral midazolam.
Pri sočasni uporabi zdravila REYATAZ / ritonavirja in parenteralnega midazolama je potrebna previdnost.
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.
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.
92 4.8 Undesirable effects
97 4. 8 Neželeni učinki
Among patients receiving REYATAZ 300 mg with ritonavir 100 mg, the frequency of jaundice was 17%.
Pri bolnikih, ki so prejemali zdravilo REYATAZ v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg, je bila pogostnost zlatenice 17%.
Adult patients The following adverse reactions of moderate intensity or greater with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs have also been reported.
Odrasli bolniki Poročali so tudi o naslednjih neželenih učinkih zmerne ali močneje jakosti, ki bi vsaj lahko bili povezani s terapevtskimi shemami, ki so vključevale zdravilo REYATAZ in enega ali več nukleozidnih/ nukleotidnih zaviralcev reverzne transkriptaze.
Renal and urinary disorders:
občasni: nefrolitiaza, hematurija, proteinurija, Bolezni sečil: polakisurija;
Skin and subcutaneous tissue disorders:
98 redki: bolečina v ledvicah
rare: vesiculobullous rash, eczema, vasodilatation
pogosti: izpuščaj; Bolezni kože in podkožja: občasni: urtikarija, alopecija, pruritus; redki: vezikobulozen izpuščaj, ekcem, vazodilatacija
Co-infected
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.
94 patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Pri sočasno okuženih bolnikih je verjetnost za izhodiščno zvišanje jetrnih transaminaz večja kot pri bolnikih brez kroničnega virusnega hepatitisa.
Single doses up to 1,200 mg have been taken by healthy volunteers without symptomatic untoward effects.
Pri zdravih prostovoljcih posamični odmerki do 1. 200 mg niso povzročili simptomatskih neželenih učinkov.
At high doses that lead to high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
Pri velikih odmerkih, ki povzročijo veliko izpostavljenost zdravilu, se lahko pojavita zlatenica, ki je posledica indirektne (nekonjugirane) hiperbilirubinemije (brez spremljajočih sprememb testov jetrnih funkcij), ali podaljšanje intervala PR (glejte poglavji 4. 4 in 4. 8).
Resistance Antiretroviral treatment naive patients In antiretroviral treatment naive patients, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
Odpornost Bolniki, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili
An atazanavir resistance phenotype is expressed in all recombinant viral clones containing the I50L substitution in a variety of genetic backgrounds.
100 Pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, je substitucija I50L, včasih v kombinaciji s spremembo A71V, značilna odpornostna substitucija proti atazanavirju.
95 Antiretroviral treatment experienced patients In antiretroviral treatment experienced patients, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Bolniki, ki so se predhodno že zdravili s protiretrovirusnimi zdravili Pri bolnikih, ki so se predhodno že zdravili s protiretrovirusnimi zdravili, so pojav odpornosti proti atazanavirju odkrili pri 100 izolatih bolnikov z ugotovljeno virološko odpovedjo ob terapiji, ki je vključevala atazanavir, atazanavir + ritonavir ali atazanavir + sakvinavir.
Atazanavir susceptibility was evaluated in 943 clinical isolates from patients without prior atazanavir exposure and exhibited a wide array of genotypic and phenotypic patterns.
Navzkrižna odpornost in vitro pri virusih, odpornih na druge zaviralce proteaz Občutljivost za atazanavir so vrednotili pri 943 kliničnih izolatih, pridobljenih pri bolnikih, ki se še niso zdravili z atazanavirjem in pri tem ugotovili različne genotipske in fenotipske vzorce.
In vitro, there was a clear trend toward decreased susceptibility to atazanavir as isolates exhibited high resistance levels to multiple protease inhibitors.
In vitro je bila prisotna jasna tendenca k manjši občutljivosti za atazanavir, če so izolati kazali večjo stopnjo odpornosti za večje število zaviralcev proteaz.
Clinical results In antiretroviral naive patients Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naïve patients comparing REYATAZ/ ritonavir (300 mg/ 100 mg once daily) to lopinavir/ ritonavir (400 mg/ 100 mg twice daily), each in combination with fixed dose tenofovir/ emtricitabine (300 mg/ 200 mg tablets once daily).
Klinični rezultati Pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili Študija 138 je mednarodno, randomizirano, odprto, multicentrično, prospektivno preskušanje, ki je pri 883 bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, primerjalo uporabo zdravila REYATAZ/ 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 tenofovirja/ emtricitabina (300 mg/ 200 mg tablete enkrat na dan).
Table 2:
101 Tabela 2:
Efficacy Outcomes at Week 48 (Study 138) for the CVR (NC=F) analysis REYATAZ/ ritonavira lopinavir/ ritonavirb (300 mg/ 100 mg (400 mg/ 100 mg once daily) twice daily)
Izidi učinkovitosti v 48. tednu (študija 138) pri analizi CVR REYATAZ/ ritonavira (300 mg/ 100 mg enkrat na dan)
Parameter
(NC=F) lopinavir/ ritonavirb (400 mg/ 100 mg dvakrat na dan)
HIV RNA < 50 copies/ ml,% c All patients Baseline Characteristics HIV RNA
Parameter HIV RNA < 50
96 CD4 count
Število celic CD4