natgillin/translations-raw huggingface dataset:
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Večje tveganje za lipodistrofijo so povezali z individualnimi dejavniki, kot je večja starost, in dejavniki, povezanimi z zdravilom, npr. dolgotrajnejše protiretrovirusno zdravljenje in spremljajoče presnovne motnje.
Clinical examination should include evaluation for physical signs of fat redistribution.
Klinični pregled mora obsegati tudi oceno telesnih znakov prerazporeditve maščevja.
Combination antiretroviral therapy (CART), including REYATAZ (with or without ritonavir)-based CART, is associated with dyslipidaemia.
Kombinirano protiretrovirusno zdravljenje (CART; “ combination antiretroviral therapy ”), vključno s kombiniranim protiretrovirusnim zdravljenjem, ki temelji na zdravilu REYATAZ (z ritonavirjem ali brez), je povezano s pojavom dislipidemij.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Razmisliti je treba o merjenju lipidov v serumu in glukoze na tešče.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Motnje lipidov je treba klinično ustrezno zdraviti (glejte poglavje 4. 8).
The clinical impact of such findings has not been demonstrated in the absence of specific studies on cardiovascular risk.
Klinični vpliv teh izsledkov ni ugotovljen, ker ni bilo specifičnih študij kardiovaskularne ogroženosti.
The selection of antiretroviral therapy must be guided principally by antiviral efficacy.
Izbira protiretrovirusnega zdravljenja mora temeljiti predvsem na protivirusni učinkovitosti.
Consultation with standard guidelines for management of dyslipidaemia is recommended.
Priporočamo upoštevanje standardnih smernic za zdravljenje dislipidemije.
Hyperglycaemia New onset diabetes mellitus, hyperglycaemia, and exacerbation of existing diabetes mellitus have been reported in patients receiving protease inhibitors.
Hiperglikemija Pri bolnikih, ki so se zdravili z zaviralci proteaz, so poročali o pojavu novonastalega diabetesa mellitusa, hiperglikemije ali poslabšanju obstoječega diabetesa mellitusa.
In some of these, the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
V nekaterih primerih je bila hiperglikemija huda in v nekaterih primerih povezana tudi s ketoacidozo.
Many patients had confounding medical conditions, some of which required therapy with medicinal products that have been associated with development of diabetes or hyperglycaemia.
Številni bolniki so imeli sočasne bolezni, od katerih so nekatere zahtevale zdravljenje z zdravili, ki lahko povzročijo nastanek diabetesa ali hiperglikemije.
Hyperbilirubinaemia Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving REYATAZ (see section 4.8).
Hiperbilirubinemija Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, se je pojavilo reverzibilno zvišanje indirektnega (nekonjugiranega) bilirubina, kar je povezano z inhibicijo UDP- glukuroniltransferaze (UGT) (glejte poglavje 4. 8).
Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving REYATAZ should be evaluated for alternative etiologies.
Če se pri bolniku, ki se zdravi z zdravilom REYATAZ, pojavi zvišanje vrednosti jetrnih transaminaz, ki jih spremlja zvišanje vrednosti bilirubina, je treba ugotoviti morebiten alternativni vzrok.
Dose reduction of atazanavir is not recommended because it may result in a loss of therapeutic effect and development of resistance.
Zmanjšanje odmerka atazanavirja ni priporočljivo, ker lahko povzroči izgubo terapevtskega učinka in pojav odpornosti.
Combinations of REYATAZ and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Kombinacija zdravila REYATAZ z indinavirjem ni raziskana, zato sočasna uporaba teh dveh zdravil ni priporočljiva (glejte poglavje 4. 5).
Nephrolithiasis Nephrolithiasis has been reported in patients receiving REYATAZ (see section 4.8).
Nefrolitiaza Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, so poročali o pojavu nefrolitiaze (glejte poglavje 4. 8).
Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindrom imunske reaktivacije Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
4 Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
4 mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Osteonekroza Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART – combination antiretroviral therapy) ali obojim.
Interactions with other medicinal products Co-administration of REYATAZ with simvastatin or lovastatin is not recommended (see section 4.5).
Medsebojno delovanje z drugimi zdravili Zdravila REYATAZ ni priporočljivo uporabljati sočasno s simvastatinom ali z lovastatinom (glejte poglavje 4. 5).
Co-administration of REYATAZ with nevirapine or efavirenz is not recommended (see section 4.5).
Sočasna uporaba zdravila REYATAZ in nevirapina ali efavirenza ni priporočljiva (glejte poglavje 4. 5).
If the coadministration of REYATAZ with an NNRTI is required, an increase in the dose of both REYATAZ and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
Če je potrebno sočasno zdravljenje z zdravilom REYATAZ in z nenukleozidnim zaviralcem reverzne transkriptaze (NNRTI; “ non- nucleoside reverse transcriptase inhibitor ”), je v primeru sočasne uporabe efavirenza treba razmisliti o povečanju odmerka zdravila REYATAZ do 400 mg in povečanju odmerka ritonavirja do 200 mg, pri čemer je potreben skrben klinični nadzor.
Co-administration of REYATAZ with ritonavir and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Zdravila REYATAZ z ritonavirjem ni priporočljivo uporabljati skupaj z zdravili, ki inducirajo CYP3A4 (glejte poglavji 4. 3 in 4. 5).
The concomitant use of REYATAZ and oral contraceptives should be avoided (see section 4.5).
Izogibati se je treba sočasni uporabi zdravila REYATAZ in peroralnih kontraceptivov (glejte poglavje 4. 5).
Co-administration of voriconazole and REYATAZ with ritonavir is not recommended unless an assessment of the benefit/ risk justifies the use of voriconazole (see section 4.5).
Sočasna uporaba vorikonazola in zdravila REYATAZ z ritonavirjem ni priporočljiva, razen če ocena koristi/ tveganj ne opravičuje uporabe vorikonazola (glejte poglavje 4. 5).
Concomitant use of REYATAZ/ ritonavir and fluticasone or other glucocorticoids that are metabolized 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).
Sočasne uporabe zdravila REYATAZ/ ritonavirja in flutikazona ali drugih glukokortikoidov, ki se presnavljajo s CYP3A4, ne priporočamo, razen v primerih, ko 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).
Co-administration of REYATAZ with proton pump inhibitors is not recommended (see section 4.5).
Sočasna uporaba zdravila REYATAZ in zaviralcev protonske črpalke ni priporočljiva (glejte poglavje 4. 5).
If the combination of REYATAZ with a proton pump inhibitor is judged unavoidable, close clinical monitoring is 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.
Odmerkov zaviralcev protonske črpalke, ki so primerljivi z 20 mg omeprazola, se ne sme preseči.
Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Laktoza Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
When REYATAZ and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
Pri sočasni uporabi zdravila REYATAZ in ritonavirja, lahko prevladajo presnovne interakcijske značilnosti ritonavirja, saj je ritonavir močnejši zaviralec CYP3A4 kot atazanavir.
Atazanavir is metabolised in the liver through CYP3A4.
Atazanavir se v jetrih presnavlja s CYP3A4 in le- tega zavira.
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).
5 terapevtski indeks, npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralne oblike midazolama in alkaloidi ergot, zlasti ergotamin in dihidroergotamin (glejte poglavje 4. 3).
5 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 ”).
Interactions between REYATAZ and other medicinal products
Interakcije med zdravilom REYATAZ in drugimi zdravili
Co-administered medicinal
Sočasno uporabljena
Medicinal
Vrednoteno
Recommendations
Priporočila za
products (dose in mg)
zdravila (odmerek v mg)
product assessed
zdravilo
(90% CI) (90% CI) (90% CI)
(90% IZ) (90% IZ) (90% IZ)
co-administration
sočasno uporabo
ANTI-INFECTIVES Antiretrovirals Protease inhibitors:
ZDRAVILA ZA ZDRAVLJENJE OKUŽB Protiretrovirusna zdravila Zaviralci proteaz:
The co-administration of REYATAZ/ ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
Sočasne uporabe zdravila REYATAZ/ ritonavirja in drugih zaviralcev proteaz niso raziskovali.
Therefore, such co-administration is not recommended.
Pri sočasni uporabi pričakujemo, da se bo izpostavljenost drugim zaviralcem proteaz povečala, zato sočasne uporabe ne priporočamo.
Ritonavir 100 mg QD
Ritonavir 100 mg 1x/ dan
Ritonavir 100 mg once
Ritonavir 100 mg
(atazanavir 300 mg QD)
(atazanavir 300 mg 2x/ dan)
↑ 3.50*
↑ 3, 50 *
↑ 2.20*
↑ 2, 20 *
↑ 8.13*
↑ 8, 13 *
daily is used as a
enkrat na dan se
studies conducted in HIV- infected patients
študije, izvedene pri bolnikih, okuženih z virusom HIV
(2.44, 5.03)
(2, 44; 5, 03)
(1.56, 3.11)
(1, 56; 3, 11)
(4.59, 14.39)
(4, 59; 14, 39)
booster of atazanavir pharmacokinetics.
uporablja kot stopnjevalec
* In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28).
(n=33) primerjali z atazanavirjem 400 mg brez ritonavirja (n=28).
Coadministration of REYATAZ/ ritonavir and indinavir is not recommended (see section 4.4).
Sočasne uporabe zdravila REYATAZ / ritonavirja in indinavirja ne priporočamo (glejte poglavje 4. 4).
Nucleoside/ nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg BID +
Nukleozidni/ nukleotidni zaviralci Lamivudin 150 mg 2x/ dan + zidovudin 300 mg 2x/ dan
Based on these data
Na osnovi teh podatkov in ker
zidovudine 300 mg BID (atazanavir 400 mg QD)
Pomembnih vplivov na koncentracije lamivudina in zidovudina niso (atazanavir 400 mg 1x/ dan)
No significant effect on lamivudine and zidovudine concentrations was observed.
opazili.
and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of REYATAZ/ ritonavir with these medicinal products is not expected to significantly alter the exposure of the co- administered drugs.
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 pomembneje spremenila.
The co-administration of REYATAZ/ ritonavir with abacavir is not expected to significantly alter the exposure of abacavir.
Pri sočasni uporabi zdravila REYATAZ / ritonavirja z abakavirjem pomembnejših sprememb v izpostavljenosti abakavirju ne pričakujemo.
Didanosine (buffered tablets) 200 mg/ stavudine 40 mg, both single dose (atazanavir 400 mg
Didanozin (pufrane tablete) 200 mg/ stavudin 40 mg, oboje v enkratnem odmerku (atazanavir 400 mg enkratni
Didanosine should be taken at the fasted state 2 hours after
Didanozin mora bolnik jemati na tešče 2 uri po zdravilu REYATAZ / ritonavirju, ki ju vzame
single dose)
odmerek)
atazanavir, simultaneous ↓ 0.13 ↓ 0.11 ↓ 0.16 administration
↓ 0, 16
REYATAZ/ ritonavir taken with food.
Pri
The co-administration of
sočasna uporaba z
(0.08, 0.21) (0.06, 0.18) (0.10, 0.27) with ddI+d4T
ddI+d4T (na tešče) atazanavir,
REYATAZ/ ritonavir
(0, 08; 0, 21)
(fasted)
(0, 06; 0, 18)
with stavudine is not expected to
(0, 10; 0, 27)
No significant effect on didanosine and stavudine concentrations was observed.
sočasni uporabi zdravila REYATAZ / ritonavirja s
significantly alter the exposure of stavudine.
uporaba 1 uro po
6
stavudinom
Co-administered medicinal products (dose in mg)
ddI+d4T (na tešče)
Medicinal AUC Cmax Cmin product assessed (90% CI) (90% CI) (90% CI)
(0, 61; 1, 73)
Recommendations concerning co-administration
pomembnejših sprememb v
Didanosine (enteric coated
Didanozin (gastrorezistentne
Didanosine (with
Didanozin (skupaj
↓ 0.66
↓ 0, 66
↓ 0.62
↓ 0, 62
↑ 1.25
↑ 1, 25
capsules) 400 mg single dose (atazanavir 300 mg QD with
kapsule) 400 mg enkratni odmerek (atazanavir 300 mg
food)
s hrano)
(0.59, 0.73)
(0, 59; 0, 73)
(0.52, 0.74)
(0, 52; 0, 74)
(0.92, 1.69)
(0, 92; 1, 69)
ritonavir 100 mg QD)
1x/ dan z ritonavirjem 100 mg 1x/ dan)
↓ 0.78 * ↓ 0.84 * ↓ 0.77 * atazanavir
↓ 0, 78 * ↓ 0, 84 * ↓ 0, 77 * atazanavir
300 mg QD (atazanavir 300 mg QD with ritonavir 100 mg QD) studies conducted in HIV- infected patients
300 mg 1x/ dan (atazanavir 300 mg 1x/ dan z ritonavirjem 100 mg 1x/ dan) študije, izveden pri bolnikih, okuženih z virusom HIV
(0.65, 0.94) (0.70, 1.00) (0.57-1.02) * In a combined analysis from several clinical studies, atazanavir/ ritonavir 300/ 100 mg co-administered with tenofovir disoproxil fumarate 300 mg (n=39) was compared to atazanavir/ ritonavir 300/ 100 mg (n=33).
(0, 65; 0, 94) (0, 70; 1, 00) (0, 57- 1, 02) * Kombinirana analiza večih kliničnih študij, v katerih so uporabo atazanavirja/ ritonavirja 300/ 100 mg skupaj s tenofovirdizoproksil fumaratom v odmerku 300 mg (n=39) primerjali z uporabo atazanavirja/ ritonavirja 300/ 100 mg (n=33).
The efficacy of REYATAZ/ ritonavir in combination with tenofovir 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).
Učinkovitost zdravila REYATAZ/ ritonavirja v kombinaciji s tenofovirjem 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).
The mechanism of interaction between atazanavir and tenofovir is unknown.
Mehanizem interakcije med atazanavirjem in tenofovirjem ni znan.
Tenofovir disoproxil fumarate 300 mg QD (atazanavir 300
Tenofovirdizoproksil fumarat 300 mg 1x/ dan (atazanavir
tenofovir
tenofovir - ↑ 1, 37 ↑ 1, 34 ↑ 1, 29
Patients should be closely monitored for
Bolnike je treba skrbno nadzirati glede pojava
mg QD with ritonavir 100 mg
300 mg 1x/ dan z ritonavirjem
↑ 1.37 ↑ 1.34 ↑ 1.29 disoproxil
dizoproksil (1, 30; 1, 45) (1, 20; 1, 51) (1, 21; 1, 36)
tenofovir-associated
neželenih učinkov
QD)
100 mg 1x/ dan)
(1.30, 1.45) (1.20, 1.51) (1.21, 1.36) fumarate
fumarat
adverse events, including renal disorders.
tenofovirja, vključno z delovanjem ledvic.
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg QD
Nenukleozidni zaviralci reverzne transkriptaze (NNRTI- ji) Efavirenz 600 mg 2x/ dan
Co-administration of
Sočasne uporabe
(atazanavir 400 mg QD with
(atazanavir 400 mg 2x/ dan z
↔ 1.00*
↔ 1, 00 *
↑ 1.17*
↑ 1, 17 *
↓ 0.58*
↓ 0, 58 *
efavirenz with
efavirenza in zdravila
ritonavir 100 mg QD)
(popoldan): vse ritonavirjem 100 mg 1x/ dan)
with food
skupaj s hrano
(0.91, 1.10)
(0, 91; 1, 10)
(1.08, 1.27)
(1, 08; 1, 27)
(0.49, 0.69)
(0, 49; 0, 69)
REYATAZ/ ritonavir is not recommended (see
REYATAZ / ritonavirja ne priporočamo (glejte poglavje 4. 4).
Efavirenz 600 mg QD (atazanavir 400 mg QD with
Efavirenz 600 mg 1x/ dan
atazanavir (pm): all administered
(atazanavir 400 mg 1x/ dan z
↔ 1.06*/ **
(popoldan): vse
↔ 1.09*/ **
↔ 1, 06 * / **
↔ 1.12*/ **
↔ 1, 09 * / **
section 4.4)
↔ 1, 12 * / **
ritonavir 200 mg QD)
ritonavirjem 200 mg 1x/ dan)
(0.90, 1.26)
(0, 90; 1, 26)
(0.95, 1.26)
(0, 95; 1, 26)
(0.84, 1.49)
(0, 84; 1, 49)
* When compared to REYATAZ 300 mg/ ritonavir 100 mg once daily in the evening without efavirenz.
* Pri primerjavi zdravila REYATAZ 300 mg/ ritonavirja 100 mg enkrat na dan zvečer brez efavirenza.
The mechanism of efavirenz/ atazanavir interaction is CYP3A4 induction. ** based on historical comparison.
Mehanizem interakcije efavirenz/ atazanavir je indukcija CYP3A4. ** na osnovi predhodnih primerjav.
Nevirapine 200 mg BID
Nevirapin 200 mg 2x/ dan
↑ 1.26
↑ 1, 26
↑ 1.21
↑ 1, 21
↑ 1.35
↑ 1, 35
(atazanavir 400 mg QD with ritonavir 100 mg QD) study
(atazanavir 400 mg 1x/ dan z ritonavirjem 100 mg 1x/ dan)
(1.17, 1.36) ↓ 0.81*
(1, 17; 1, 36)
(1.11, 1.32) ↔ 1.02*
(1, 11; 1, 32)
(1.25, 1.47) ↓ 0.41*
(1, 25; 1, 47)
nevirapine with REYATAZ/ ritonavir is
nevirapina in zdravila REYATAZ / ritonavirja
conducted in HIV infected
študija izvedena pri bolnikih, okuženih z virusom HIV
(0.65, 1.02)
(0, 65; 1, 02)
(0.85, 1.24)
(0, 85; 1, 24)
(0.27, 0.60)
(0, 27; 0, 60)
not recommended (see
ne priporočamo (glejte poglavje 4. 4).
The mechanism of nevirapine/ atazanavir interaction is CYP3A4 induction.
Mehanizem interakcije nevirapin/ atazanavir je indukcija CYP3A4.
section 4.4)
zdravila (odmerek v mg)
Clarithromycin 500 mg BID
Antibiotiki Klaritromicin 500 mg 2x/ dan
↑ 1.94 ↑ 1.50 ↑ 2.60 clarithromycin
↑ 2, 60
No recommendation
Priporočil za
(atazanavir 400 mg QD)
(atazanavir 400 mg 1x/ dan)
regarding dose reduction can be made;
(1, 75; 2, 16)
clarithromycin (0.26, 0.34) (0.24, 0.33) (0.34, 0.42)
(1, 32; 1, 71)
↑ 1.28 ↔ 1.06 ↑ 1.91 atazanavir (1.16, 1.43) (0.93, 1.20) (1.66, 2.21)
(2, 35; 2, 88)
A dose reduction of clarithromycin may result in subtherapeutic concentrations of 14-OH clarithromycin.
zmanjšanje odmerka ne moremo podati.
The mechanism of the clarithromycin/ atazanavir interaction is CYP3A4 inhibition.
Če se
clarithromycin.
↓ 0, 30
Antifungals
↓ 0, 28
Ketoconazole 200 mg QD (atazanavir 400 mg QD)
↓ 0, 38
No significant effect on atazanavir concentrations was observed.
zdravilo REYATAZ /
Ketoconazole and itraconazole should be used cautiously with
klaritromicin
Itraconazole
(0, 26; 0, 34)
Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
(0, 24; 0, 33)
REYATAZ/ ritonavir.
(0, 34; 0, 42)
7 Co-administered medicinal
ritonavir uporablja skupaj s
AUC
↑ 1, 28
Cmax
↔ 1, 06
Cmin
↑ 1, 91
Recommendations
klaritromicinom, je
products (dose in mg)
(1, 16; 1, 43)
product assessed
(0, 93; 1, 20)
(90% CI) (90% CI) (90% CI)
(1, 66; 2, 21)
concerning
potrebna previdnost.
co-administration
Itrakonazol
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.
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.
itraconazole (> 200 mg/ day) are not recommended.
Uporaba visokih odmerkov ketokonazola in itrakonazola (> 200 mg / dan) ni priporočljiva.
Co-administration of REYATAZ/ ritonavir and voriconazole has not been studied.
Sočasne uporabe zdravila REYATAZ / ritonavirja in vorikonazola niso raziskovali.
Co-administration of voriconazole and REYATAZ/ ritonavir is
Sočasna uporaba vorikonazola in zdravila REYATAZ /
The effect of co-administration of oral voriconazole and low dose (100 mg) oral ritonavir was investigated in healthy volunteers.
Učinek sočasne uporabe nizkega peroralnega odmerka vorikonazola in nizkega peroralnega (100 mg) odmerka ritonavirja so raziskovali pri zdravih prostovoljcih.
Low doses of ritonavir (100 mg BID) decreased the Cmax and AUC of voriconazole (90% CI) by an average of 24% (↓ 9% to ↓ 36%) and 39% (↓ 22% to ↓ 52%), respectively.
Nizki odmerki ritonavirja (100 mg 2x/ dan) so zmanjšali vrednosti Cmax vorikonazola (90% IZ) v povprečju za 24% (↓9% do ↓36%), vrednosti AUC vorikonazola (90% IZ) pa v povprečju za 39% (↓22% do ↓52%).
Administration of voriconazole resulted in a minor decrease in steady state Cmax and AUC of ritonavir (90% CI) with an average of 24% (↓ 6% to ↓ 39%) and 14% (↓ 26% to ↑ 1%), respectively.
Uporaba vorikonazola je povzročila manjše spremembe vrednosti Cmax and AUC ritonavirja (90% IZ) v stanju dinamičnega ravnovesja, pri čemer se je vrednost Cmax v povprečju zmanjšala za 24% (↓6% do ↓39%), vrednost AUC pa za 14% (↓26% do ↑1%).
not recommended unless an assessment of the benefit/ risk to the patient justifies the use of voriconazole (see section 4.4).
ritonavirja ni priporočljiva, če ocena koristi/ tveganj pri bolniku ne upraviči uporabe vorikonazola (glejte poglavje 4. 4).
Patients should be carefully monitored for adverse events and/ or loss of efficacy during the co-administration of voriconazole and REYATAZ/ ritonavir.
Pri sočasni uporabi vorikonazola in zdravila REYATAZ / ritonavirja je bolnike treba skrbno nadzirati glede pojava neželenih učinkov in/ ali izgube učinkovitosti.
Fluconazole 200 mg QD (atazanavir 300 mg and ritonavir 100 mg QD) Antimycobacterial
Flukonazol 200 mg 1x/ dan (atazanavir 300 mg in ritonavir 100 mg 1x/ dan)
Atazanavir and fluconazole concentrations were not significantly modified when REYATAZ/ ritonavir was co-administered with fluconazole.
Pri sočasni uporabi zdravila REYATAZ / ritonavirja in flukonazola se koncentracije atazanavirja in flukonazola niso pomembneje spremenile.
No dosage adjustments are needed for REYATAZ/ ritonavir and fluconazole.
Odmerkov zdravila REYATAZ / ritonavirja ali flukonazola ni treba prilagajati.
Rifabutin 150 mg QD
Zdravila za zdravljenje okužb z mikobakterijami Rifabutin 150 mg 1x/ dan