natgillin/translations-raw huggingface dataset:
Co-administration of Atazanavir Krka and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Atazanavir Krka i lijekova koji induciraju CYP3A4 (vidjeti dijelove 4.3 i 4.5).
Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Istovremena primjena s lijekovima koji su supstrati izoenzima CYP3A4 citokroma P450 i imaju usku terapijsku širinu (npr. kvetiapin, lurasidon, alfuzozin, astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralno primijenjen midazolam (za mjere opreza kod parenteralno primijenjenog midazolama vidjeti dio 4.5) i alkaloidi ergota, osobito ergotamin, dihidroergotamin, ergonovin, metilergonovin) (vidjeti dio 4.5).
HIV RNA Mean Change from Baseline, log10 copies/ml
HIV RNK prosječna promjena od početne vrijednosti, log10 kopija/ml
(400 mg/ 100 mg twice daily (n=123)
(400 mg/ 100 mg dvaput na dan) n=123
400 mg with ritonavir 100 mg with TDM may be considered (see sections 4.6 and 5.2).
100 mg uz praćenje koncentracije lijeka (vidjeti dijelove 4.6 i 5.2).
, vesiculobullous rash, eczema,
, vezikulobulozni osip, ekcem,
ritonavir AUC ↓ 36% ritonavir cmax ↓ 27% ritonavir cmin ↓ 45%
ritonavir Cmax ↓ 27% ritonavir Cmin ↓ 45%
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA <400 copies/ml (<50 copies/ml) for atazanavir + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).
udio bolesnika s HIV RNK <400 kopija/ml (<50 kopija/ml) u skupini koja je primala atazanavir s ritonavirom iznosio je 84% (72%), a u skupini koja je primala lopinavir s ritonavirom 82% (72%).
Alternative antiretroviral therapy to Atazanavir Krka may be considered if jaundice or scleral icterus is unacceptable to a patient.
Može se razmotriti primjena drugih antiretrovirusnih lijekova ako su žutilo kože ili sklera bolesniku neprihvatljivi.
This side effect is usually not dangerous in adults and infants older than 3 months of age; but it might be a symptom of a serious problem.
Ta nuspojava obično nije opasna u odraslih i dojenčadi starijoj od
Data on withdrawal of ritonavir from atazanavir boosted regimen (see also section 4.4) Study 136 (INDUMA)
Podaci o ukidanju ritonavira iz režima pojačanog atazanavirom (vidjeti dio 4.4)
Concentrations of these immunosuppressants may be increased when co-administered with atazanavir due to CYP3A4 inhibition.
Koncentracije ovih imunosupresiva mogu biti povišene kad se primjenjuju istovremeno s atazanvirom zbog inhibicije CYP3A4.
Table 1: Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for Atazanavir Krka capsules with ritonavir Body Weight (kg)
Tablica 1: Doza Atazanavir Krka kapsula s ritonavirom za pedijatrijske bolesnike (u dobi od 6 do manje od 18 godina i tjelesne težine od najmanje 15 kg) Tjelesna težina (kg)
Cmax ng/mL Geometric mean (CV%) AUC ng•h/mL Geometric mean (CV%)
Geometrijska sredina (CV%) AUC ng•h/mL
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2- blockers.
Mehanizam interakcije je smanjenje topljivosti atazanavira s povećanjem želučanog pH zbog H2 blokatora.
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.
100 mg uz lagani obrok rezultirala je povećanjem AUC-a za 33% i povećanjem Cmax i 24-satne koncentracije atazanavira za 40% u odnosu na primjenu natašte.
For randomised patients, the mean time of prior antiretroviral exposure was 138
Prosječno trajanje prethodne izloženosti randomiziranih bolesnika antiretrovirusnim lijekovima iznosilo je 138 tjedana za inhibitore proteaze,
Co-administration with atazanavir may result in increased concentrations of salmeterol and an increase in salmeterolassociated adverse events.
Istovremena primjena s atazanvirom može rezultirati povišenim koncentracijama salmeterola i pojačanim nuspojavama povezanima sa salmeterolom.
Atazanavir Krka 150 mg hard capsules Atazanavir Krka 200 mg hard capsules Atazanavir Krka 300 mg hard capsules atazanavir
Atazanavir Krka 150 mg tvrde kapsule Atazanavir Krka 200 mg tvrde kapsule Atazanavir Krka 300 mg tvrde kapsule
(300 mg/ 100 mg once daily (n=120)
(300 mg/ 100 mg jedanput na dan) n=120
The rash usually disappears within 2 weeks without any change to your atazanavir treatment.
2 tjedna bez ikakve promjene u Vašem liječenju atazanavirom.
Concomitant use of St. John's wort with atazanavir may be expected to result in significant reduction in plasma levels of atazanavir.
Može se očekivati da istovremena primjena gospine trave i atazanvira rezultira značajnim sniženjem razine atazanavira u plazmi.
If the co-administration of Atazanavir Krka with an NNRTI is required, an increase in the dose of both Atazanavir Krka and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
Ako je potrebno istovremeno primjenjivati Atazanavir Krka s nekim NNRTI-jem, može se razmotriti povišenje doze lijeka Atazanavir Krka na 400 mg i ritonavira na 200 mg u kombinaciji s efavirenzom, uz pažljivo praćenje bolesnika.
common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitis a
često: žutica; manje često: hepatitis, kolelitijaza a, kolestaza a;
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.
Krka se ne smije primjenjivati u djece mlađe od 3 mjeseca zbog sigurnosnih razloga, osobito kada se uzme u obzir mogući rizik od kernikterusa.
Atazanavir has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving atazanavir 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or atazanavir 300 mg with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration).
Sigurnost atazanavira procijenjena je u kombiniranoj terapiji s drugim antiretrovirusnim lijekovima u kontroliranim kliničkim ispitivanjima u 1806 odraslih bolesnika koji su primali atazanavir 400 mg jedanput na dan (1151 bolesnika, srednje trajanje liječenja 52 tjedna i maksimalno trajanje liječenja
Norbuprenorphine AUC ↑105% Norbuprenorphine cmax ↑61% Norbuprenorphine cmin ↑101%
Norbuprenorfin Cmax ↑61% Norbuprenorfin Cmin ↑101%
The capsule cap is imprinted with white mark A300.
Na kapici kapsule je utisnuta bijela oznaka A300.
The capsule cap is imprinted with black mark A200.
Na kapici kapsule je utisnuta crna oznaka A200.
N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; sporedna supstitucija za rezistenciju na inhibitore proteaze: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
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).
Ne preporučuje se istovremena primjena atazanvira s ritonavirom i ovih glukokortikoida, osim ako je moguća korist od liječenja veća od rizika od sistemskih učinaka kortikosteroida (vidjeti dio 4.4).
a The mean baseline CD4 cell count was 337 cells/mm3 (range: 14 to 1,543 cells/mm3) and the mean baseline plasma HIV-1
Prosječni početni broj CD4 stanica iznosio je 337 stanica/mm3 (raspon: 14 do 1543 stanica/mm3) i prosječna početna razina
ERECTILE DYSFUNCTION PDE5 Inhibitors Sildenafil, tadalafil, vardenafil
Sildenafil, tadalafil, vardenafil
The recommended dose of Atazanavir Krka capsules is 300 mg once daily taken with ritonavir 100 mg once daily and with food.
Preporučena doza Atazanavir Krka kapsula je 300 mg jedanput na dan i uzima se s ritonavirom u dozi od 100 mg jedanput na dan i s hranom.
The co-administration of stavudine with atazanavir is not expected to significantly alter the exposure of stavudine.
Ne očekuje se da će istovremena primjena stavudina i atazanvira značajno promijeniti izloženost stavudinu.
No dose adjustment is needed for atazanavir.
Nije potrebna prilagodba doze atazanvira.
Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Metabolički paramateri Tjelesna težina i razine lipida i glukoze u krvi mogu biti povećane tijekom antiretrovirusne terapije
Interactions with other medicinal products The combination of Atazanavir Krka with atorvastatin is not recommended (see section 4.5).
Interakcije s drugim lijekovima Ne preporučuje se istovremena primjena lijeka Atazanavir Krka s atorvastatinom (vidjeti dio 4.5).
Lamotrigine should be used with caution in combination with atazanavir /ritonavir.
Lamotrigin se mora primjenjivati uz oprez u kombinaciji s atazanvirom i ritonavirom.
The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Učestalost hepatitisa ili povišenja transaminaza koji su se u bolesnika s istovremenim infekcijama razvili tijekom liječenja atazanavirom bila je slična onoj pri primjeni komparatorskih protokola (vidjeti dio 4.4).
Coadministration of diltiazem and atazanavir /ritonavir has not been studied.
Istovremena primjena diltiazema i atazanvira s ritonavirom nije ispitana.
How to take Atazanavir Krka
Kako uzimati Atazanavir Krka
Nevirapine AUC ↑26% (↑17% Nevirapine cmax ↑21% (↑11% Nevirapine cmin ↑35% (↑25%
Nevirapin AUC ↑26% (↑17% ↑36%) Nevirapin Cmax ↑21% (↑11% ↑32%) Nevirapin Cmin ↑35% (↑25% ↑47%)
HIV RNA <50 copies/ml by select baseline PI substitutions,
HIV RNK <50 kopija/ml prema početnim odabranim supstitucijama za rezistenciju na inhibitor proteaze,
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).
U odraslih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima Ispitivanje 138 međunarodno je, randomizirano, multicentrično, prospektivno ispitivanje otvorenog tipa u bolesnika koji prethodno nisu bili liječeni u kojem se atazanavir/ritonavir (300 mg/100 mg jedanput na dan) uspoređivao s lopinavirom/ritonavirom (400 mg/100 mg dvaput na dan), gdje su obje te kombinacije bile davane zajedno s fiksnom dozom tenofovirdizoproksilfumarata/emtricitabina (300 mg/200 mg tablete, jedanput na dan).
Atazanavir Krka with ritonavir should be used with caution in patients with mild hepatic impairment.
Atazanavir Krka s ritonavirom treba primjenjivati s oprezom u bolesnika s blagim oštećenjem funkcije jetre.
f Intent-to-treat analysis, with missing values considered as failures.
f Analiza podataka bolesnika predviđenih za liječenje, a vrijednosti koje su nedostajale smatrale su se neuspjehom.
shellac black ferric oxide (E172)
šelak crni željezov oksid (E172)
How to store Atazanavir Krka
Kako čuvati Atazanavir Krka
The most frequently reported laboratory abnormalities in paediatric patients receiving atazanavir oral powder was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4; 16%) and increased amylase (Grade 3-4; 33%), generally of non-pancreatic origin.
Najčešće zabilježeni poremećaj laboratorijskih nalaza u pedijatrijskih bolesnika koji su primali atazanavir oralni prašak bilo je povišenje ukupnog bilirubina (≥ 2,6 GGN, 3.-4. stupanj; 16%) i povišena vrijednost amilaze (3-4;
This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
ako se smatra potrebnom, u bolesnika sa suprimiranim virusnim opterećenjem HIV-om i sa sojem
What Atazanavir Krka looks like and contents of the pack Atazanavir Krka 150 mg hard capsules
Kako Atazanavir Krka izgleda i sadržaj pakiranja Atazanavir Krka 150 mg tvrde kapsule
The potential for PR prolongation should be considered in cases of overdose (see section
U slučajevima predoziranja treba uzeti u obzir mogućnost produljenja PR intervala (vidjeti dio 4.9).
Patients should be closely monitored for tenofovir disoproxil fumarate-associated adverse reactions, including renal disorders.
Bolesnike treba pažljivo nadzirati zbog nuspojava tenofovirdizoproksilfumarata,
- Gallbladder problems uncommonly happen in people taking atazanavir.
- Manje često mogu se pojaviti problemi sa žučnim kamencima u osoba koje uzimaju atazanavir.
potassium hydroxide
kalijev hidroksid
Co-administration of lurasidone with atazanavir is contraindicated as this may increase lurasidone-related toxicity (see section 4.3).
Istodobna primjena lurasidona i atazanvira je kontraindicirana, jer može povećati toksičnost povezanu s primjenom lurasidona (vidjeti dio
14-OH clarithromycin 14-OH clarithromycin AUC ↓70%
14-OH klaritromicin AUC ↓70% (↓74%
Grazoprevir concentrations were greatly increased when coadministered with atazanavir/ritonavir.
Koncentracije grazoprevira su značajno porasle kada je primjenjivan istodobno s atazanavirom/ritonavirom.
Total rifabutin and 25-O-desacetylrifabutin AUC ↑119% (↑78%
25-O-dezacetil-rifabutin AUC ↑990%
Norgestimate AUC ↑85% (↑67% Norgestimate cmax ↑68% (↑51% Norgestimate cmin ↑102% (↑77%
Norgestimat AUC ↑85% (↑67% ↑105%) Norgestimat Cmax ↑68% (↑51% ↑88%) Norgestimat Cmin ↑102% (↑77% ↑131%)
Study 045 is a randomised, multicenter trial comparing atazanavir /ritonavir (300/100 mg once daily) and atazanavir /saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
(300/100 mg jedanput na dan) i atazanavir/sakvinavir (400/1200 mg jedanput na dan) uspoređivani s lopinavirom + ritonavirom (400/100 mg, fiksna kombinacija doza, dvaput na dan), a svaka se od tih terapija primjenjivala u kombinaciji s tenofovirdizoproksilom (vidjeti dijelove 4.5 i 4.8) i jednim NRTI-jem u bolesnika u kojih je dva ili više prethodnih protokola s najmanje jednim inhibitorom proteaze, NRTI-jem i NNRTI-jem bilo virološki neuspješno.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1353/002
Raltegravir AUC ↑41% Raltegravir cmax ↑24% Raltegravir c12hr ↑77% The mechanism is UGT1A1 inhibition.
Raltegravir Cmax ↑24% Raltegravir C12hr ↑77%
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1353/001
- Kidney stones uncommonly happen in people taking atazanavir.
- Manje često mogu se pojaviti bubrežni kamenci u osoba koje uzimaju atazanavir.
Frequency de novo PI substitution (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
Only when atazanavir with ritonavir is co-administered with efavirenz, a dose increase of ritonavir to 200 mg once daily could be considered.
Samo kad se atazanavir s ritonavirom primjenjuje istovremeno s efavirenzom može se razmotriti povišenje doze ritonavira na
The choice of Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient's treatment history (see sections 4.4 and 5.1).
Odabir lijeka Atazanavir Krka za liječenje već liječenih odraslih i pedijatrijskih bolesnika treba biti utemeljen na pojedinačnom testiranju virusne rezistencije i prethodnom liječenju pojedinog bolesnika
Co-administration of Atazanavir Krka with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate or norethindrone has not been studied, and therefore should be avoided (see section 4.5).
Nije ispitana istovremena primjena lijeka Atazanavir Krka i druge hormonske ili oralne kontracepcije koja sadrži progestagene, osim norgestimata ili noretindrona, te se stoga mora izbjegavati (vidjeti dio
Co-administration of Atazanavir Krka with nevirapine or efavirenz is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena lijeka Atazanavir Krka s nevirapinom ili efavirenzom (vidjeti dio 4.5).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
povišen indeks tjelesne mase mogu, između ostalog, biti neki od mnogih čimbenika rizika za razvoj ove bolesti.
Co-administration of voriconazole and Atazanavir Krka with ritonavir is not recommended, unless an assessment of the benefit/risk justifies the use of voriconazole.
Ne preporučuje se istovremena primjena vorikonazola i lijeka Atazanavir Krka s ritonavirom, osim ako procjena omjera koristi i rizika opravdava primjenu vorikonazola.
No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg. the need to consider that co-administration of voriconazole and atazanavir without ritonavir may affect atazanavir concentrations co-administration of fluticasone and atazanavir without ritonavir may increase fluticasone concentrations relative to fluticasone given alone if an oral contraceptive is administered with atazanavir without ritonavir, it is recommended that the oral contraceptive contain no more than 30 µg of ethinyloestradiol no dose adjustment of lamotrigine is required
- treba imati na umu da: istovremena primjena vorikonazola i atazanavira bez ritonavira može utjecati na koncentracije atazanavira istovremena primjena flutikazona i atazanavira bez ritonavira može povisiti koncentracije flutikazona u odnosu na koncentracije flutikazona primijenjenog samostalno ako se istovremeno s atazanavirom bez ritonavira primjenjuje oralni kontraceptiv,
Clarithromycin AUC ↑94% (↑75% Clarithromycin cmax ↑50% (↑32% Clarithromycin cmin ↑160%
Klaritromicin AUC ↑94% (↑75% ↑116%) Klaritromicin Cmax ↑50% (↑32% ↑71%) Klaritromicin Cmin ↑160% (↑135% ↑188%)
(See also section 4.4 Withdrawal of ritonavir only under restrictive conditions).
(vidjeti dijelove 4.5 i 5.1). (Vidjeti i "Prekid primjene ritonavira samo pod restriktivnim uvjetima" u dijelu 4.4).
When co-administered with tenofovir disoproxil fumarate, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg and tenofovir disoproxil fumarate 300 mg (all as a single dose with food).
preporučuje se primijeniti 300 mg atazanvira sa 100 mg ritonavira i 300 mg tenofovirdizoproksilfumatata (svi se primjenjuju kao jednokratna doza s hranom).
Co-administration of Atazanavir Krka with proton pump inhibitors is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena lijeka Atazanavir Krka s inhibitorima protonske pumpe (vidjeti dio 4.5).
% (responder/evaluabled)
% (bolesnici s odgovorom/bolesnici koje se moglo procijeniti d)
Unboosted Atazanavir Krka must not be used in patients with severe hepatic impairment.
Nepojačani Atazanavir Krka ne smije se primjenjivati u bolesnika s teškim oštećenjem funkcije jetre.
Nephrolithiasis has been reported in patients receiving atazanavir (see section 4.8).
Nefrolitijaza U bolesnika koji primaju atazanavir zabilježena je nefrolitijaza (vidjeti dio 4.8).
Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of these medicinal products and atazanavir is not expected to significantly alter the exposure of the co-administered medicinal products.
Na temelju ovih podataka i budući da se ne očekuje značajan učinak ritonavira na farmakokinetiku
Didanosine (with food) Didanosine AUC ↓34% (↓41% ↓27%) Didanosine cmax ↓38% (↓48% ↓26%) Didanosine cmin
Didanozin AUC ↓34% (↓41% ↓27%) Didanozin Cmax ↓38% (↓48% ↓26%) Didanozin Cmin ↑25% (↓8% ↑69%)
Voriconazole AUC ↑561% Voriconazole cmax ↑438% (↑355% Voriconazole cmin ↑765% (↑571%
Vorikonazol AUC ↑561% (↑451% ↑699%) Vorikonazol Cmax ↑438% (↑355% ↑539%) Vorikonazol Cmin ↑765% (↑571%
Sofosbuvir 400 mg / velpatasvir 100 mg /voxilaprevir 100 mg single dose*
Sofosbuvir 400 mg / velpatasvir 100 mg /voksilaprevir 100 mg jedna doza* (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
No dosage adjustment is necessary if methadone is co
Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s atazanavirom.
NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 300 mg hard capsules atazanavir
NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 300 mg tvrde kapsule atazanavir
* In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28).
* U kombiniranoj analizi, atazanavir 300 mg s ritonavirom 100 mg (n=33)
* When compared to atazanavir 300 mg and ritonavir 100 mg without nevirapine.
300 mg/ritonavir 100 mg bez nevirapina.
Co-administration of voriconazole and atazanavir with ritonavir is not recommended unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see section 4.4).
Ne preporučuje se istovremena primjena vorikonazola i atazanvira s ritonavirom osim kad procjena omjera koristi i rizika za bolesnika opravdava primjenu vorikonazola (vidjeti dio 4.4).
While the concentration of ethinyloestradiol was increased with atazanavir given alone, due to both UGT and CYP3A4 inhibition by atazanavir, the net effect of atazanavir/ritonavir is a decrease in ethinyloestradiol levels because of the inducing effect of ritonavir.
UGT i CYP3A4, neto učinak atazanavira/ritonavira je sniženje razina etinilestradiola zbog inducirajućeg učinka ritonavira.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING CONTAINER LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA SPREMNIK
- grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)
- lijekovi koji sadrže grazoprevir, ukljućujući fiksnu kombinaciju elbasvir/grazoprevir i fiksnu kombinaciju glekaprevir/pibrentasvir (koja se koristi u liječenju kronične infekcije virusom hepatitisa C) Nemojte uzimati sildenafil s lijekom Atazanavir Krka kad se sildenafil primjenjuje za liječenje plućne arterijske hipertenzije.
Atazanavir Krka 200 mg hard capsules Each hard capsule contains 200 mg atazanavir (as sulphate).
Atazanavir Krka 200 mg tvrde kapsule Jedna tvrda kapsula sadrži 200 mg atazanavira (u obliku atazanavirsulfata).
ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Klaritromicin 500 mg dvaput na dan (atazanavir 400 mg jedanput na dan)
Atazanavir Krka is not a cure for HIV infection.
Upozorenja i mjere opreza Atazanavir Krka neće izliječiti HIV-infekciju.
During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μM) of atazanavir corresponding to 30 fold the free drug concentration at cmax in humans.
kod koncentracije (30 μM) atazanavira koja je odgovarala 30 puta većoj koncentraciji slobodnog lijeka pri Cmax u ljudi.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/003 30 hard capsules EU/1/19/1353/004 90 (3 x 30) hard capsules
EU/1/19/1353/004 90 (3 x 30) tvrdih kapsula
Voriconazole AUC ↓33% (↓42% Voriconazole cmax ↓10% (↓22% Voriconazole cmin ↓39% (↓49%
Vorikonazol AUC ↓33% (↓42% ↓22%) Vorikonazol Cmax ↓10% (↓22% ↓4%) Vorikonazol Cmin ↓39% (↓49% ↓28%)