natgillin/translations-raw huggingface dataset:
shellac titanium dioxide (E171) potassium hydroxide
šelak titanijev dioksid (E171)
d Intent-to-treat analysis, with missing values considered as failures.
d Analiza podataka bolesnika predviđenih za liječenje, s time da su se vrijednosti koje su nedostajale smatrale neuspjehom.
Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance.
Tijekom praćenja nakon stavljanja lijeka u promet, prijavljena je kronična bubrežna bolest u bolesnika zaraženih HIV-om, liječenih atazanavirom, sa ili bez ritonavira.
- medicines containing St. John's wort (Hypericum perforatum, a herbal preparation) - triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) - simvastatin and lovastatin (used to lower blood cholesterol).
- triazolam i peroralni (uzima se kroz usta) midazolam (primjenjuje se za liječenje poremećaja spavanja i/ili ublažavanje tjeskobe)
QT prolongation: Dose related asymptomatic prolongations in PR interval with atazanavir have been observed in clinical studies.
Produljenje QT intervala: U kliničkim je ispitivanjima opaženo asimptomatsko produljenje
In some cases, nephrolithiasis has been associated with acute renal failure or renal insufficiency.
nefrolitijaza je povezana s akutnim zatajenjem bubrega ili bubrežnom insuficijencijom.
Treatment- Experienced atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=25
Bolesnici koji su prethodno bili liječeni atazanavir kapsulama i ritonavirom (300 mg/100 mg jedanput na dan) n=25
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%).
Među bolesnicima koji su primali atazanavir 400 mg jedanput na dan ili atazanavir 300 mg s ritonavirom 100 mg jedanput na dan, jedine vrlo često zabilježene nuspojave bilo koje težine s barem mogućom povezanošću s protokolima koji sadrže atazanavir i jedan ili više NRTI-jeva bile su mučnina
Co-administration of atazanavir with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations associated with increased grazoprevir concentrations (see section 4.3).
Istodobna primjena lijeka atazanavira s lijekovima koji sadrže grazoprevir, uključujući fiksnu kombinaciju elbasvir/grazoprevir kontraindicirana je zbog povišene koncentracije grazoprevira i elbasvira u plazmi i postoji rizik povišenja vrijednosti ALT-a zbog povećane koncentracije grazoprevira (vidjeti dio 4.3).
Studies conducted in HIV- infected patients.
Ispitivanja provedena u bolesnika s HIV-infekcijom.
Co-administration of atazanavir and indinavir is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena atazanvira i indinavira (vidjeti dio 4.4).
Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving atazanavir should be evaluated for alternative aetiologies.
Potrebno je provjeriti alternativne uzroke povišenja jetrenih transaminaza koje može nastati uz povišenje bilirubina u bolesnika koji primaju atazanavir.
Atazanavir Krka is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Atazanavir Krka je kontraindiciran u bolesnika s teškom insuficijencijom jetre (vidjeti dijelove 4.2, 4.4 i 5.2).
a Intent-to-treat analysis, with missing values considered as failures.
a Analiza podataka bolesnika predviđenih za liječenje, s time da su se vrijednosti koje su nedostajale smatrale neuspjehom.
However, Atazanavir Krka is not recommended in patients undergoing haemodialysis (see sections 4.2 and
Međutim, Atazanavir Krka se ne preporučuje u bolesnika na hemodijalizi (vidjeti dijelove 4.2 i 5.2).
* When compared to atazanavir 300 mg once daily with ritonavir 100 mg once daily and tenofovir disoproxil fumarate 300 mg all as a single dose with food.
300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan i tenofovirdizoproksilfumaratom 300 mg, svi primijenjeni kao jednokratna doza s hranom.
ANTIFUNGALS Ketoconazole 200 mg once daily (atazanavir 400 mg once daily)
Ketokonazol 200 mg jedanput na dan (atazanavir 400 mg jedanput na dan)
Frequency de novo PI substitution (n=26)a none none a
Učestalost de novo supstitucija za rezistenciju na inhibitor proteaze (n=26)
- If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to Atazanavir Krka
- Ako je potrebno primijeniti tenofovirdizoproksil ili antagonist H2-receptora, možda će trebati razmotriti povećanje doze lijeka Atazanavir Krka na 400 mg primijenjenu s ritonavirom od
INFORMATION IN BRAILLE Atazanavir Krka 200 mg
16. PODACI NA BRAILLEOVOM PISMU Atazanavir Krka 200 mg
INFORMATION IN BRAILLE Atazanavir Krka 150 mg
16. PODACI NA BRAILLEOVOM PISMU Atazanavir Krka 150 mg
The body of the capsule is white or almost white colour, the cap of the capsule is dark brown colour.
Tvrda želatinozna kapsula, veličine br. 00. Tijelo kapsule je bijele do gotovo bijele boje, kapica kapsule je tamnosmeđe boje.
Atazanavir Krka 150 mg hard capsules
Atazanavir Krka 150 mg tvrde kapsule
Co-administration of atazanvir with voxilaprevircontaining regimens is not recommended.
Ne preporučuje se istodobna primjena atazanavira s režimima koji uključuju vokislaprevir.
Co-administration of lamotrigine and atazanavir /ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Zbog indukcije UGT1A4, istodobna primjena lamotrigina i atazanvira s ritonavirom može sniziti koncentracije lamotrigina u plazmi.
Capsule shell of Atazanavir Krka 200 mg hard capsules Body: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine
Ovojnica kapsule Atazanavir Krka 200 mg tvrdih kapsula Tijelo: titanijev dioksid (E171) žuti željezov oksid (E172) crveni željezov oksid (E172) želatina
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Njemačka
c PI major L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY, I54ALMSTV, L76V, V82AFLST, I84V,
c Glavna supstitucija za rezistenciju na inhibitore proteaze L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV,
Atazanavir Krka once daily dose ritonavir once daily dosea
Doza lijeka Atazanavir Krka jedanput na dan
Table 5:
(tablica 5).
300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil
S tenofovirdizoproksilfumaratom od 300 mg jedanput na dan (što odgovara 245 mg tenofoviridizoproksila)
Atazanavir Krka 300 mg hard capsules
Atazanavir Krka 300 mg tvrde kapsule
OPIOIDS
ANTIBIOTICI
Uncommon (may affect up to 1 in 100 people): - peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) - hypersensitivity (allergic reaction) - asthenia (unusual tiredness or weakness) - weight decreased, weight gain, anorexia (loss of appetite), appetite increased - depression, anxiety, sleep disorder - disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream - syncope (fainting), hypertension (high blood pressure) - dyspnoea (shortness of breath) - pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis,
astenija (neobičan umor ili slabost) smanjenje tjelesne težine, povećanje tjelesne težine, anoreksija (gubitak apetita), pojačan apetit depresija, tjeskoba, poremećaj spavanja dezorijentacija, amnezija (gubitak pamćenja), omaglica, somnolencija (izrazita pospanost),
Your doctor will evaluate how severe yourliver disease is before deciding whether you can take Atazanavir Krka - if you are taking any of these medicines: see also Other medicines and Atazanavir Krka - rifampicin (an antibiotic used to treat tuberculosis) - astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without prescription); cisapride (used to treat gastric reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); and alfuzosin (used to treat enlarged prostatic gland) - quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder), lurasidone (used to treat schizophrenia)
- rifampicin (antibiotik za liječenje tuberkuloze) - astemizol ili terfenadin (obično se primjenjuju za liječenje simptoma alergije i mogu se nabaviti bez recepta); cisaprid (primjenjuje se za liječenje želučanog refluksa, tj. žgaravice); pimozid (primjenjuje se za liječenje shizofrenije); kinidin ili bepridil (primjenjuju se za liječenje poremećaja srčanog ritma); ergotamin, dihidroergotamin, ergonovin, metilergonovin (primjenjuju se za liječenje glavobolje); i alfuzosin (primjenjuje se za liječenje povećanja prostate) - kvetiapin (primjenjuje se za liječenje shizofrenije, bipolarnog poremećaja i velikog depresivnog poremećaja), lurasidon (primjenjuje se za liječenje shizofrenije)
Elbasvir 50 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily)
Elbasvir 50 mg jedanput na dan (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
Hepatic impairment
genotip bolesnika.
Musculoskeletal and connective tissue disorders uncommon: muscle atrophy, arthralgia, myalgia; rare: myopathy
manje često: mišićna atrofija, artralgija, mialgija;
Capsule shell of Atazanavir Krka 150 mg hard capsules Body: titanium dioxide (E171) gelatine
Ovojnica kapsule Atazanavir Krka 150 mg tvrdih kapsula Tijelo: titanijev dioksid (E171) želatina
Co-administration of atazanvir with glecaprevir/pibrentasvir is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3)
Istodobna primjena atazanvira s glekaprevir/pibrentasvirom kontraindicirana je jer postoji rizik povišenja vrijednosti ALT-a zbog značajnog povećanja koncentracije glekaprevira i pibrentasvira u plazmi (vidjeti dio 4.3).
common: rash; uncommon: erythemia multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndrome a,b angioedemaa, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndrome a,b
, angioedem a urtikarija, alopecija, pruritus; rijetko: Stevens-Johnsonov sindrom a,b
the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Mehanizam interakcije klaritromicin/atazanavir je inhibicija CYP3A4.
INFORMATION IN BRAILLE Atazanavir Krka 300 mg
16. PODACI NA BRAILLEOVOM PISMU Atazanavir Krka 300 mg
These are listed under Do not take Atazanavir Krka, at the start of Section 2.
Ti su lijekovi navedeni na početku dijela 2., ispod podnaslova „Nemojte uzimati Atazanavir Krka“.
Due to CYP3A4 inhibition by atazanavir, concentrations of quetiapine are expected to increase.
Zbog inhibicije CYP3A4, očekuje se da će primjena atazanvira povisiti razine lurasidona u plazmi.
administered with atazanavir.
Kad se uspoređuje s atazanavirom
- in patients with at least one functional CYP2C19 allele, close clinical monitoring for a loss of both voriconazole (clinical signs) and atazanavir (virologic response) efficacy is recommended.
- za bolesnike s najmanje jednim funkcionalnim CYP2C19 alelom preporučuje se poman klinički nadzor kako bi se uočio eventualni gubitak djelotvornosti vorikonazola
Co-administration of salmeterol and Atazanavir Krka is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena salmeterola i lijeka Atazanavir Krka (vidjeti dio 4.5).
Capsule shell of Atazanavir Krka 150 mg hard capsules:
Ovojnica kapsule Atazanavir Krka 150 mg tvrdih kapsula:
In HIV-infected adult patients (n=33, combined studies) the mean half-life within a dosing interval for atazanavir was 12 hours at steady state following a dose of 300 mg daily with ritonavir 100 mg once daily with a light meal.
kombinirana ispitivanja), prosječni poluvijek unutar intervala doziranja atazanavira iznosio je 12 sati u stanju dinamičke ravnoteže nakon doze od 300 mg na dan zajedno s ritonavirom u dozi od 100 mg jedanput na dan, uz lagani obrok.
Co-administration of nevirapine and atazanavir is not recommended (see section 4.4)
Ne preporučuje se istovremena primjena nevirapina i atazanvira (vidjeti dio 4.4)
Serum concentrations of verapamil may be increased by atazanavir due to CYP3A4 inhibition.
Atazanvir može povisiti koncentracije verapamila u serumu zbog inhibicije enzima CYP3A4.
Atazanavir AUC: ↑250% (↑144%
Glekaprevir AUC: ↑553% (↑424%
flatulence (wind), dry mouth, abdominal distension - angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) - alopecia (unusual hair loss or thinning), pruritus (itching) - muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles)
pankreatitis (upala gušterače), gastritis (upala želuca), aftozni stomatitis (ranice u ustima i groznica na usnama), disgeuzija (promjene osjeta okusa), flatulencija (vjetrovi), suha usta, rastezanje trbuha angioedem (teško oticanje kože i drugih tkiva, najčešće usana i očiju) alopecija (neobičan gubitak ili prorijeđenost kose), pruritus (svrbež) mišićna atrofija (gubitak mišića), artralgija (bol u zglobovima), mialgija (bol u mišićima) intersticijalni nefritis (upala bubrega), hematurija (krv u mokraći), proteinurija (višak proteina u mokraći), polakizurija (učestalo mokrenje) ginekomastija (povećanje grudi u muškaraca) bol u prsištu, malaksalost (opće loše stanje), vrućica nesanica (poteškoće sa spavanjem)
Capsule shell of Atazanavir Krka 300 mg hard capsules Body: titanium dioxide (E171) gelatine
Ovojnica kapsule Atazanavir Krka 300 mg tvrdih kapsula Tijelo: titanijev dioksid (E171) želatina
Antiretroviral treatment experienced adult patients In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 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.
100 izolata iz bolesnika u kojih je terapija atazanavirom, atazanavirom s ritonavirom ili atazanavirom sa sakvinavirom bila virološki neuspješna utvrđeno je da se razvila rezistencija na atazanavir.
Treatment-Naive atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=16
Bolesnici koji prethodno nisu bili liječeni atazanavir kapsulama i ritonavirom (300 mg/100 mg jedanput na dan) n=16
The body of the capsule is white or almost white colour, the cap of the capsule is brownish-orange colour.
Tvrda želatinozna kapsula (kapsula), veličine br. 1. Tijelo kapsule je bijele do gotovo bijele boje, kapica kapsule je smećkastonarančaste boje.
ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily)
ANTI - HCV LIJEKOVI Grazoprevir 200 mg jedanput na dan (atazanavir 300 mg / ritonavir 100 mg jedanput na dan)
Caution should be exercised when verapamil is coadministered with atazanavir.
Potreban je oprez kad se verapamil primjenjuje istovremeno s atazanvirom.
- in patients without a functional CYP2C19 allele, close clinical and laboratory monitoring of voriconazole-associated adverse events is recommended.
CYP2C19 alela preporučuje se poman nadzor kliničkih i laboratorijskih parametara koji upućuju na nuspojave povezane s vorikonazolom
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA < 400 copies/ml (< 50 copies/ml) in the atazanavir + ritonavir arm and the lopinavir + ritonavir arm were 55% (40%) and 56% (46%), respectively.
(< 50 kopija/ml) u skupini koja je primala atazanavir s ritonavirom iznosio je 55% (40%), a u skupini koja je primala lopinavir s ritonavirom 56% (46%).
There were fewer treatment discontinuations in the unboosted atazanavir group (1 vs. 4 subjects in the atazanavir + ritonavir group).
4 ispitanika u skupini koja je primala atazanavir + ritonavir).
25-O-desacetyl-rifabutin AUC 25-O-desacetyl-rifabutin cmax 25-O-desacetyl-rifabutin cmin
AUC ukupnog rifabutina i 25-O-dezacetil-rifabutina
Co-administration of atazanavir with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3).
Istodobna primjena atazanavira s lijekovima koje sadrže fiksnu kombinaciju glekaprevir/pibrentasvir, kontraindicirana je, jer postoji rizik povišenja vrijednosti ALT-a zbog značajnog povećanja koncentracije glekaprevira i pibrentasvira u plazmi (vidjeti dio 4.3).
vasodilatation
vazodilatacija
Atazanavir Krka with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Ne preporučuje se primjenjivati Atazanavir Krka s ritonavirom u bolesnika na hemodijalizi (vidjeti dijelove 4.4 i 5.2).
Marketing Authorisation Holder KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
Renal impairment: No dosage adjustment is needed in patients with renal impairment.
Oštećenje funkcije bubrega: U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze.
Coadministration with atazanavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-associated adverse events, including hypotension, visual changes, and priapism.
PDE5 i pojačanim nuspojavama povezanima s PDE5, uključujući hipotenziju, poremećaje vida i prijapizam.
Atazanavir Krka with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Primjena lijeka Atazanavir Krka u kombinaciji s ritonavirom kontraindicirana je u bolesnika s umjerenom insuficijencijom jetre (vidjeti dijelove 4.2, 4.4 i 5.2).
Atazanavir Krka 200 mg hard capsules
Atazanavir Krka 200 mg tvrde kapsule
uncommon: hypertension
Krvožilni poremećaji manje često: hipertenzija
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), black ferric oxide (E172), gelatine and ink (shellac, titanium dioxide (E171), potassium hydroxide
Kapica: titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172), želatina i tinta (šelak, titanijev dioksid (E171), kalijev hidroksid)
If the combination of Atazanavir Krka with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of Atazanavir Krka to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded.
Atazanavir Krka na 400 mg uz 100 mg ritonavira; ne smije se prekoračiti doza inhibitora protonske pumpe koja je usporediva s dozom omeprazola od 20 mg.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
(stanje koje nastaje kad imunološki sustav napada zdrava tjelesna tkiva).
Co-administration of salmeterol with atazanavir is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena salmeterola i atazanvira (vidjeti dio 4.4).
Kidney stones have been reported in patients taking atazanavir.
Druge nuspojave prijavljene u bolesnika liječenih atazanavirom:
For patients who are taking tenofovir disoproxil, if atazanavir/ritonavir with both tenofovir disoproxil and an H2receptor antagonist are coadministered, a dose increase of atazanavir to 400 mg with 100 mg of ritonavir is recommended.
Za bolesnike koji uzimaju tenofovirdizoproksil, ako se atazanvir/ritonavir primjenjuju istovremeno s tenofovirdizoproksilfumaratom i antagonistom H2 receptora,
Co-administration of efavirenz and atazanavir is not recommended (see section 4.4)
Ne preporučuje se istovremena primjena efavirenza i atazanvira (vidjeti dio 4.4).
Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving atazanavir.
U bolesnika koji primaju atazanavir zabilježeni su Stevens-Johnsonov sindrom (SJS), multiformni eritem, toksične kožne erupcije i medikamentozni osip s eozinofilijom i sistemskim simptomima
Co-administration of atorvastatin with atazanavir is not recommended.
Ne preporučuje se istovremena primjena atorvastatina s atazanvirom.
Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with atazanavir (see section 4.4).
PDE5 za erektilnu disfunkciju uzimaju istovremeno s atazanvirom (vidjeti dio 4.4).
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Mehanizam interakcije je smanjena topljivost atazanavira s povišenjem želučanog pH
The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with Atazanavir Krka and ritonavir.
Prije početka terapije lijekom Atazanavir Krka i ritonavirom potrebno je pročitati Sažetak opisa svojstava lijeka za ritonavir.
Glecaprevir AUC : ↑553% Glecaprevir cmax : ↑306% (↑215% Glecaprevir cmin : ↑1330% (↑885% Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir cmax : ↑29% (↑15% Pibrentasvir cmin: ↑129% (↑95%
Pibrentasvir AUC : ↑64% (↑48% ↑82%) Pibrentasvir Cmax : ↑29% (↑15% ↑45%) Pibrentasvir Cmin: ↑129% (↑95% ↑168%)
Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine ink:
Kapica: titanijev dioksid (E171) žuti željezov oksid (E172) crveni željezov oksid (E172) želatina tinta:
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg atazanavir (as sulphate).
Jedna tvrda kapsula sadrži 150 mg atazanavira (u obliku atazanavirsulfata).
Atazanavir AUC ↑7% (↓2% Atazanavir cmax ↑2% (↓4% ↑8%) Atazanavir cmin ↑15% (↑2% ↑29%) Elbasvir AUC: ↑376% (↑307% Elbasvir cmax: ↑315% (↑246% Elbasvir cmin: ↑545% (↑451%
Elbasvir AUC: ↑376% (↑307% ↑456%) Elbasvir Cmax: ↑315% (↑246% ↑397%) Elbasvir Cmin: ↑545% (↑451% ↑654%)
In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen (see section 4.4) The same recommendations for drug drug interactions would apply except: that co-administration is not recommended with tenofovir, boceprevir, carbamazepine, phenytoin, phenobarbital, proton pump inhibitors, and buprenorphine.
- ne preporučuje se istovremena primjena s tenofovirom, boceprevirom, karbamazepinom, fenitoinom, fenobarbitalom, inhibitorima protonske pumpe i buprenorfinom.
ANTIMYCOBACTERIAL Rifabutin 150 mg twice weekly (atazanavir 300 mg and ritonavir 100 mg once daily)
Rifabutin 150 mg dvaput tjedno (atazanavir 300 mg i ritonavir 100 mg jedanput na dan)
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Ako se u tih bolesnika dokaže pogoršanje bolesti jetre,
Tenofovir disoproxilfumarate AUC ↑37% (↑30% ↑45%) Tenofovir disoproxil fumarate Cmax
Tenofovirdizoproksilfumarat Cmax ↑34% Tenofovirdizoproksilfumarat Cmin ↑29%
(indigestion) - fatigue (extreme tiredness)
poremećaj hoda (abnormalan način hodanja)
Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine and ink (shellac, black ferric oxide (E172), potassium hydroxide
Kapica: titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), želatina i tinta (šelak, crni željezov oksid (E172), kalijev hidroksid)
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 300 mg atazanavir (as sulphate).
Jedna tvrda kapsula sadrži 300 mg atazanavira (u obliku atazanavirsulfata).