natgillin/translations-raw huggingface dataset:
Hepatic impairment: Atazanavir is primarily hepatically metabolised and increased plasma concentrations were observed in patients with hepatic impairment (see sections 4.2 and 4.3).
Oštećenje funkcije jetre: Atazanavir se prvenstveno metabolizira u jetri, pa su u bolesnika s oštećenjem jetre bile opažene povišene koncentracije atazanavira u plazmi (vidjeti dijelove 4.2 i 4.3).
ATV/RTVb (300 mg/ 100 mg once daily) n=120
ATV/RTVb (300 mg/ 100 mg jedanput na dan) n=120
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2blockers.
Mehanizam interakcije je smanjenje topljivosti atazanavira s povećanjem želučanog pH zbog H2 blokatora.
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA <400 copies/ml (<50 copies/ml) for REYATAZ + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).
Analizom prema liječenju, isključujući vrijednosti koje su nedostajale, udio bolesnika s HIV RNK <400 kopija/ml (<50 kopija/ml) u skupini koja je primala REYATAZ s ritonavirom iznosio je 84% (72%), a u skupini koja je primala lopinavir s ritonavirom 82% (72%).
BRISTOL-MYERS SQUIBB, S.A. Tel: + 34 91 456 53 00
SQUIBB, S.A. Tel: + 34 91 456 53 00
Eleven subjects (13%) in the unboosted REYATAZ group and 6 (7%) in the REYATAZ + ritonavir group, had virologic rebound.
U jedanaest ispitanika (13%) u skupini liječenoj nepojačanim lijekom REYATAZ i 6 (7%) ispitanika u skupini koja je primala REYATAZ
Studies conducted in HIVinfected patients.
Ispitivanja provedena u bolesnika s HIV-infekcijom.
No dosage adjustments are needed for fluconazole and REYATAZ.
Nisu potrebne prilagodbe doze flukonazola i lijeka REYATAZ.
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.
REYATAZ/ritonavir se ne bi smjeo primijeniti istovremeno s triazolamom ili peroralno primijenjenim midazolamom ne smije se primijeniti (vidjeti dio 4.3), dok je oprez potreban kod istovremene primjene lijeka REYATAZ/ritonavira i parenteralnog midazolama.
White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Bijela tinta sadrži: šelak, titanijev dioksid (E171), amonijev hidroksid, propilenglikol i simetikon 6.2 Inkompatibilnosti
LIST OF EXCIPIENTS Contains aspartame and sucrose.
3. POPIS POMOĆNIH TVARI Sadrži aspartam i saharozu.
(See section 4.4 Withdrawal of ritonavir only under restrictive conditions).
"Prekid primjene ritonavira samo pod restriktivnim uvjetima" ).
Due to carbamazepine inducing effect, a reduction in REYATAZ/ritonavir exposure cannot be ruled out.
Zbog inducirajućeg učinka karbamazepina, ne može se isključiti smanjena izloženost lijeku REYATAZ/ritonaviru.
common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitisa
često: žutica; manje često: hepatitis, kolelitijazaa, kolestazaa; rijetko: hepatosplenomegalija, kolecistitis a
Co-administration of simvastatin or lovastatin with REYATAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Kontraindicirana je istovremena primjena simvastatina ili lovastatina s lijekom REYATAZ zbog povišenog rizika od miopatije uključujući rabdomiolizu (vidjeti dio 4.3).
d Ritonavir oral solution or capsule/tablet.
c Ritonavir oralna otopina d Ritonavir oralna otopina ili kapsule/tablete
SEDATIVES Benzodiazepines
Benzodiazepini
Co-administration of REYATAZ with proton pump inhibitors is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena lijeka REYATAZ s inhibitorima protonske pumpe (vidjeti dio 4.5).
Co-administration of REYATAZ with ritonavir and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Ne preporučuje se istovremena primjena lijeka REYATAZ s ritonavirom i lijekova koji induciraju CYP3A4 (vidjeti dijelove 4.3 i 4.5).
Each capsule of REYATAZ 300 mg contains 300 mg atazanavir.
Jedna kapsula REYATAZ 300 mg sadrži 300 mg atazanavira.
Each sachet of REYATAZ 50 mg oral powder contains 50 mg atazanavir.
Jedna vrećica REYATAZ 50 mg oralnog praška sadrži 50 mg atazanavira.
Patients with moderate to severe hepatic insufficiency (see sections 4.2 and 4.4).
Bolesnici s umjerenom do teškom insuficijencijom jetre (vidjeti dijelove 4.2 i 4.4).
Excipient with known effect: 109.57 mg of lactose per capsule.
Pomoćna tvar s poznatim učinkom: 109,57 mg laktoze po kapsuli.
Combinations of REYATAZ and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Kombinacije lijeka REYATAZ i indinavira nisu ispitane pa se ne preporučuje njihova istovremena primjena (vidjeti dio 4.5).
Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily (atazanavir 400 mg once daily)
Nukleozidni/nukleotidni inhibitori reverzne transkriptaze (NRTI-jevi) Lamivudin 150 mg dvaput na dan + zidovudin 300 mg dvaput na dan (atazanavir 400 mg jedanput na dan)
Ethinyloestradiol AUC ↑48% (↑31% Ethinyloestradiol Cmax ↑15% (↓1% Ethinyloestradiol Cmin ↑91% (↑57%
Etinilestradiol AUC ↑48% (↑31% Etinilestradiol Cmax ↑15% (↓1% ↑32%) Etinilestradiol Cmin ↑91% (↑57%
The most frequently reported laboratory abnormalities in paediatric patients receiving REYATAZ was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4) which occurred in 45% of patients.
Najčešće zabilježeni poremećaj laboratorijskih nalaza u pedijatrijskih bolesnika koji su primali REYATAZ bilo je povišenje ukupnog bilirubina (≥ 2,6 puta iznad gornje granice normale, 3.-4. stupanj), koje je nastalo u 45% bolesnika.
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ.
Kinidin ima uzak terapijski raspon i kontraindiciran je zbog moguće inhibicije enzima CYP3A lijekom REYATAZ.
Ethinyloestradiol AUC ↓19% (↓25% Ethinyloestradiol Cmax ↓16% (↓26% Ethinyloestradiol Cmin ↓37% (↓45%
Etinilestradiol AUC ↓19% (↓25% Etinilestradiol Cmax ↓16% (↓26% ↓5%) Etinilestradiol Cmin ↓37% (↓45%
Sofosbuvir AUC : ↑40% (↑25% ↑57%) Sofosbuvir Cmax :↑29% (↑9% ↑52%) Velpatasvir AUC: ↑93% (↑58% Velpatasvir Cmax : ↑29% (↑7% ↑56%) Voxilaprevir AUC : ↑331% (↑276% Voxilaprevir Cmax : ↑342% (↑265%
Sofosbuvir AUC : ↑40% (↑25% ↑57%) Sofosbuvir Cmax :↑29% (↑9% ↑52%) Velpatasvir AUC: ↑93% (↑58% Velpatasvir Cmax : ↑29% (↑7% ↑56%) Voksilaprevir AUC : ↑331% (↑276% Voksilaprevir Cmax : ↑342% (↑265%
Co-administration with REYATAZ/ritonavir has the potential to produce a decrease or, less often, an increase in INR (International Normalised Ratio).
Istovremena primjena s lijekom REYATAZ /ritonavirom može dovesti do sniženja ili rjeđe povišenja međunarodno normaliziranog omjera (INR).
6.6 Special precautions for disposal and other handling Instructions for use:
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
PHARMACEUTICAL FORM Oral powder
OBLIK Oralni prašak.
The co-administration of abacavir and REYATAZ is not expected to significantly alter the exposure of abacavir.
Ne očekuje se da će istovremena primjena abakavira i lijeka REYATAZ značajno promijeniti izloženost abakaviru.
100 to <200 cells/mm3
100 do <200 stanica /mm3
Co-administration of REYATAZ with nevirapine or efavirenz is not recommended (see section 4.5).
Ne preporučuje se istovremena primjena lijeka REYATAZ s nevirapinom ili efavirenzom (vidjeti dio 4.5).
ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
ANTIBIOTICI Klaritromicin 500 mg dvaput na dan (atazanavir 400 mg jedanput na dan)
These are listed under Do not take REYATAZ, at the start of Section 2.
Ti su lijekovi navedeni na početku dijela 2, ispod podnaslova
For patients not taking tenofovir, if REYATAZ 300 mg/ritonavir 100 mg and H2-receptor antagonists are coadministered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Kod bolesnika koji ne uzimaju tenofovir ako se REYATAZ 300 mg/ritonavir 100 mg primjenjuju istovremeno s antagonistima H2 receptora, ne smije se prekoračiti doza jednaka dozi famotidina od 20 mg dvaput na dan.
No drug interaction study has been performed for the coadministration of REYATAZ with benzodiazepines.
Nisu provedena ispitivanja interakcija lijekova kod istovremene primjene lijeka REYATAZ i benzodiazepina.
50 to <100 cells/mm3
50 do <100 stanica /mm3
The combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Kombinacija rifampicina i lijeka REYATAZ s istovremeno primijenjenom niskom dozom ritonavira je kontraindicirana (vidjeti dio 4.3).
Antiretroviral treatment naive adult patients
Antiretrovirusno liječenje prethodno liječenih bolesnika
Four subjects in the unboosted REYATAZ group and 2 in the REYATAZ + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
+ ritonavir imala su HIV RNK > 500 kopija/ml tijekom faze održavanja.
Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
Fenobarbital i fenotoin se moraju primjenjivati uz oprez u kombinaciji s lijekom REYATAZ i ritonavirom.
Other side effects reported for patients treated with REYATAZ are the following: Common (may affect up to 1 in 10 people): headache vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion) fatigue (extreme tiredness)
Druge nuspojave prijavljene u bolesnika liječenih lijekom REYATAZ: Često (mogu se javiti u do 1 na 10 osoba): glavobolja povraćanje, proljev, bol u trbuhu (bol ili nelagoda u želucu), mučnina, dispepsija (probavne tegobe) iscrpljenost (jaki umor)
Concomitant use of St. John's wort with REYATAZ/ritonavir may be expected to result in significant reduction in plasma levels of atazanavir.
Može se očekivati da istovremena primjena gospine trave i lijeka REYATAZ/ritonavira rezultira značajnim sniženjem razine atazanavira u plazmi.
Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with REYATAZ/ritonavir may result in increased concentrations.
Metabolizam simvastatina i lovastatina jako ovisi o enzimu CYP3A4 i istovremena primjena s lijekom REYATAZ/ritonavirom može rezultirati povišenim koncentracijama.
Effect on atazanavir and ritonavir exposure has not been studied.
Nije ispitivan utjecaj na izloženost atazanaivru i ritonaviru.
Excipient with known effect: 54.79 mg of lactose per capsule.
Pomoćna tvar s poznatim učinkom: 54,79 mg laktoze po kapsuli.
Co-administration of REYATAZ with triazolam or orally administered midazolam is contraindicated (see section 4.3), whereas caution should be used with coadministration of REYATAZ and parenteral midazolam.
Istovremena primjena lijeka REYATAZ s triazolamom ili peroralno primijenjenim midazolamom je kontraindicirana (vidjeti dio 4.3), dok je oprez potreban kod istovremene primjene lijeka REYATAZ i parenteralnog midazolama.
An additional 15 ml of beverage is added to the drinking cup for thorough rinsing of the cup and contents are mixed.
Dodatnih 15 ml pića se dodaje u čašu kako bi se isprao ostatak u šalici.
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).
Ne preporučuje se istovremena primjena lijeka REYATAZ s ritonavirom i ovih glukokortikoida, osim ako je moguća korist od liječenja veća od rizika od sistemskih učinaka kortikosteroida (vidjeti dio 4.4).
The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between REYATAZ and comparator regimens (see section 4.4).
Učestalost hepatitisa ili povišenja transaminaza koji su se u bolesnika s istovremenim infekcijama razvili tijekom liječenja lijekom REYATAZ bila je slična onoj pri primjeni komparatorskih protokola (vidjeti dio 4.4).
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
Due to carbamazepine inducing effect, a reduction in REYATAZ exposure cannot be ruled out.
Zbog inducirajućeg učinka karbamazepina, ne može se isključiti smanjena izloženost lijeku REYATAZ.
3) and mean baseline plasma HIV-1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
3) i srednja početna vrijednost HIV-1 RNK u plazmi bila je 4.67 log10 kopija /ml (raspon: 2,0 do 5,9 log10 kopija /ml).
Due to phenytoin/phenobarbital inducing effect, a reduction in REYATAZ exposure cannot be ruled out.
Zbog inducirajućeg učinka fenitoina/fenobarbitala, ne može se isključiti smanjena izloženost lijeku REYATAZ.
REYATAZ/ritonavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5associated adverse events, including hypotension, visual changes, and priapism.
REYATAZ/ritonavirom može rezultirati povišenim koncentracijama inhibitora PDE5 i pojačanim nuspojavama povezanima s PDE5, uključujući hipotenziju, poremećaje vida i prijapizam.
Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated (see section 4.3).
Sildenafil je kontraindiciran kad se primjenjuje za liječenje plućne arterijske hipertenzije (vidjeti dio 4.3).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REYATAZ 50 mg ORAL POWDER - FOIL SACHET 1.
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE REYATAZ 50 mg ORALNI PRAŠAK - FOLIJA VREĆICE 1. NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA REYATAZ 50 mg oralni prašak atazanavir
No drug interaction study has been performed for the co-administration of REYATAZ/ritonavir with benzodiazepines.
Nisu provedena ispitivanja interakcija lijekova kod istovremene primjene lijeka REYATAZ/ritonavira i benzodiazepina.
REYATAZ oral powder may be used by children at least 3 months of age and weighing at least 5 kg (see section 3 How to take REYATAZ).
REYATAZ oralni prašak mogu uzimati djeca u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg (pogledajte dio 3.
Carbamazepine should be used with caution in combination with REYATAZ.
Karbamazepin se mora primjenjivati uz oprez u kombinaciji s lijekom REYATAZ.
Paediatric patients (at least 3 months of age and weighing at least 5 kg) The doses of atazanavir oral powder and ritonavir for paediatric patients are based on body weight as shown in Table 1.
Pedijatrijski bolesnci (u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg) Doza atazanavir oralnog praška i ritonavira za pedijatrijske bolesnike temelji se na tjelesnoj težini, kako je prikazano u tablici 1. REYATAZ oralni prašak mora se uzimati s ritonavirom i s hranom.
However, REYATAZ is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
Međutim, REYATAZ se ne preporučuje u bolesnika na hemodijalizi (vidjeti dijelove 4.2 i 5.2).
For patients who are taking tenofovir disoproxil fumarate, if REYATAZ/ritonavir with both tenofovir disoproxil and an H2-receptor antagonist are coadministered,a dose increase of REYATAZ to 400 mg with 100 mg of ritonavir is recommended.
Za bolesnike koji uzimaju tenofovirdizoprokislfumarat, ako se REYATAZ/ritonavir primjenjuju istovremeno s tenofovirdizoproksilom i antagonistom H2 receptora, preporučuje se povišenje doze lijeka REYATAZ na 400 mg sa 100 mg ritonavira.
De novo substitutions in treatment experienced patients failing therapy with atazanavir + ritonavir (Study 045, 48 weeks) 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
Učestalost de novo supstitucije za rezistenciju na inhibitor proteaze (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
Before use, tap the sachet.
2. Prije primjene protresite vrećicu.
Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with REYATAZ may result in increased concentrations.
Metabolizam simvastatina i lovastatina jako ovisi o enzimu CYP3A4 i istovremena primjena s lijekom REYATAZ može rezultirati povišenim koncentracijama.
Co-administration of the PDE5 inhibitor sildenafil when used for the treatment of pulmonary arterial hypertension (PAH) only (see section 4.5).
Istovremena primjena inhibitora PDE5, sildenafila, samo kad se primjenjuje za liječenje plućne arterijske hipertenzije (PAH) (vidjeti dio 4.5).
Co-administration of REYATAZ with ritonavir and proton pump inhibitors is not recommended.
Ne preporučuje se istovremena primjena lijeka REYATAZ s ritonavirom i inhibitorima protonske pumpe.
Norgestimate AUC ↑85% (↑67% Norgestimate Cmax ↑68% (↑51% Norgestimate Cmin ↑102% (↑77%
Norgestimat AUC ↑85% (↑67% Norgestimat Cmax ↑68% (↑51% ↑88%) Norgestimat Cmin ↑102% (↑77%
Grazoprevir concentrations were greatly increased when co-administered with atazanavir/ritonavir.
Koncentracije grazoprevira su značajno porasle kada je primjenjivan istodobno s atazanavirom/ritonavirom.
Concomitant use of St. John's wort with REYATAZ may be expected to result in significant reduction in plasma levels of atazanavir.
Može se očekivati da istovremena primjena gospine trave i lijeka REYATAZ rezultira značajnim sniženjem razine atazanavira u plazmi.
Norethindrone AUC ↑110% (↑68% Norethindrone Cmax ↑67% (↑42% Norethindrone Cmin ↑262% (↑157%
Noretindron AUC ↑110% (↑68% Noretindron Cmax↑67% (↑42% Noretindron Cmin ↑262% (↑157%
A change in dose may occur when switching between oral powder and capsules.
Kod prelaska na kapsule s oralnog praška može se dogoditi i promjena doze.
For patients who are taking tenofovir disoproxil fumarate, if REYATAZ/ritonavir with both tenofovir disoproxil fumarate and an H2-receptor antagonist are co-administered, a dose increase of REYATAZ to 400 mg with 100 mg of ritonavir is recommended.
Za bolesnike koji uzimaju tenofovirdizoproksilfumarat, ako se REYATAZ/ritonavir primjenjuju istovremeno s tenofovirdizoproksilfumaratom i antagonistom H2 receptora, preporučuje se povišenje doze lijeka REYATAZ na 400 mg sa 100 mg ritonavira.
Atazanavir, the active substance of REYATAZ, is excreted in human milk.
Atazanavir, djelatna tvar lijeka REYATAZ izlučuje se u majčino mlijeko.
Voriconazole AUC ↓33% (↓42% Voriconazole Cmax ↓10% (↓22% ↓4%) Voriconazole Cmin ↓39% (↓49% ↓28%)
Vorikonazol AUC ↓33% (↓42% Vorikonazol Cmax ↓10% (↓22% ↓4%) Vorikonazol Cmin ↓39% (↓49% ↓28%)
Co-administration of REYATAZ 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 REYATAZ i druge hormonske ili oralne kontracepcije koja sadrži progestagene, osim norgestimata ili noretindrona, te se stoga mora izbjegavati (vidjeti dio 4.5).
Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ.
Koncentracije ovih antiaritmika mogu biti povišene kad se primjenjuju istovremeno s lijekom REYATAZ.
Treatment-Experienced REYATAZ Powder/ritonavir n=82
Bolesnici koji su prethodno bili liječeni REYATAZ oralnim prašakom /ritonavirom n=82
Buprenorphine, once daily, stable maintenance dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Buprenorfin, jedanput na dan, stabilna doza održavanja (atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Nenukleozidni inhibitori reverzne transkriptaze (NNRTI-jevi) Efavirenz 600 mg jedanput na dan (atazanavir 400 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
* When compared to REYATAZ 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
* Kad je uspoređivan s lijekom REYATAZ 300 mg/ritonavir 100 mg jedanput na dan, navečer, bez efavirenza.
The combination of rifampicin and REYATAZ is contraindicated (see section 4.3).
Kombinacija rifampicina i lijeka REYATAZ je kontraindicirana (vidjeti dio 4.3).
Concomitant use of salmeterol and REYATAZ/ritonavir may result in increased cardiovascular adverse events associated with salmeterol.
Istovremena primjena salmeterola i lijeka REYATAZ/ritonavira može rezultirati pojačanim kardiovaskularnim nuspojavama salmeterola.
a Intent-to-treat analysis, with missing values considered as failures.
a Analiza prema planiranom liječenju, s time da su se vrijednosti koje su nedostajale smatrale neuspjehom.
Co-administration of lurasidone with REYATAZ is contrandicated as this may increase lurasidone-related toxicity (see section 4.3).
Istodobna primjena lurasidona i lijeka REYATAZ je kontraindicirana, jer može povećati toksičnost povezanu s primjenom lurasidona (vidjeti dio 4.3.).
Bristol-Myers Squibb Pharma EEIG
SQUIBB PHARMA EEIG
Table 9: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Tablica 9: Farmakokinetika atazanavira s ritonavirom u stanju dinamičke ravnoteže u trudnica zaraženih HIV-om u sitom stanju atazanavir 300 mg s ritonavirom 100 mg
Co-administration with REYATAZ/ritonavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5inhibitor-associated adverse events.
Istovremena primjena s lijekom REYATAZ/ritonavirom može rezultirati povišenim koncentracijama inhibitora PDE5 i pojačanim nuspojavama povezanima s inhibitorom PDE5.
d Intent-to-treat analysis, with missing values considered as failures.
d Analiza prema planiranom liječenju, s time da su se vrijednosti koje su nedostajale smatrale neuspjehom.
Co-administration of lurasidone with REYATAZ is contraindicated as this may incrrease lurasidone-related toxicity (see section 4.3)
Istodobna primjena lurasidona i lijeka REYATAZ je kontraindicirana, jer može povećati toksičnost povezanu s primjenom lurasidona (vidjeti dio 4.3.)
Dose related asymptomatic prolongations in PR interval with REYATAZ have been observed in clinical studies.
U kliničkim je ispitivanjima opaženo asimptomatsko produljenje PR intervala povezano s dozom lijeka REYATAZ.
Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving REYATAZ should be evaluated for alternative aetiologies.
Potrebno je provjeriti alternativne uzroke povišenja jetrenih transaminaza koje može nastati uz povišenje bilirubina u bolesnika koji primaju REYATAZ.
BRISTOL-MYERS SQUIBB S.R.L.
SQUIBB S.R.L.
Cholelithiasis has been reported in patients receiving REYATAZ (see section 4.8).
U bolesnika koji primaju REYATAZ zabilježena je kolelitijaza (vidjeti dio 4.8).
HIV RNA <50 copies/ml, %a at least 5 to < 10 kg (REYATAZ 150 and 200 mg) at least 10 to < 15 kg at least 15 to < 25 kg at least 25 to < 35 kg
HIV RNK <50 kopija/ ml, %a Najmanje 5 do < 10 kg (REYATAZ 150 i 200 mg)
Diltiazem 180 mg once daily (atazanavir 400 mg once daily)
Diltiazem 180 mg jedanput na dan (atazanavir 400 mg jedanput na dan)
Ethinyloestradiol 35 µg + norethindrone (atazanavir 400 mg once daily)
Etinilestradiol 35 μg + noretindron (atazanavir 400 mg jedanput na dan)
Table 8: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Tablica 8: Farmakokinetika atazanavira s ritonavirom u stanju dinamičke ravnoteže u trudnica zaraženih HIV-om u sitom stanju atazanavir 300 mg s ritonavirom 100 mg
Ritonavir may decrease plasma levels of phenytoin and/or phenobarbital due to CYP2C9 and CYP2C19 induction.
Zbog indukcije CYP2C9 i CYP2C19, primjena ritonavira može sniziti razine fenitoina i/ili fenobarbitala u plazmi.
Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ/ritonavir.
Koncentracije ovih antiaritmika mogu biti povišene kad se primjenjuju istovremeno s lijekom REYATAZ/ritonavirom.
b Each sachet contains 50 mg of atazanavir.
Jedna vrećica sadrži 50 mg atazanavira.