natgillin/translations-raw huggingface dataset:
Combination of rifampicin (see section 4.5). 
Kombinacija s rifampicinom. (vidjeti dio 4.5).
Co-administration of REYATAZ with voxilaprevircontaining products is expected to increase the concentration of voxilaprevir. 
Očekuje se da istodobna primjena lijeka REYATAZ s lijekovima koji sadrže voksilaprevir povećava koncentraciju voksilaprevira.
HCV Protease Inhibitors 
Inhibitori proteaze HCV-a
Excipient with known effect: 164.36 mg of lactose per capsule. 
Pomoćna tvar s poznatim učinkom: 164,36 mg laktoze po kapsuli.
c PI major L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V. 
c Glavna supstitucija za rezistenciju na inhibitore proteaze L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; sporedna supstitucija za rezistenciju na inhibitore proteaze: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
REYATAZ with ritonavir should be used with caution in patients with mild hepatic impairment. 
REYATAZ s ritonavirom treba primjenjivati s oprezom u bolesnika s blagim oštećenjem funkcije jetre.
No dosage adjustment is necessary if methadone is coadministered with REYATAZ and ritonavir. 
Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s lijekom REYATAZ i ritonavirom.
Concomitant use of REYATAZ/ritonavir and fluticasone or other glucocorticoids that are metabolised 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). 
Ne preporučuje se istovremena primjena lijeka REYATAZ/ritionavir i flutikonazona ili drugih kortikosteroida koje metabolizira enzim CYP3A4, osim ako je moguća korist liječenja veća od rizika od učinaka sistemskih kortikosteroida, uključujući Cushingov sindrom i supresiju nadbubrežne žlijezde (vidjeti dio 4.5).
MARKETING AUTHORISATION NUMBER(S) Bottle pack 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pakiranje s bocom
Particular caution should be used when prescribing REYATAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3). 
Osobit se oprez treba primijeniti kad se REYATAZ propisuje zajedno s drugim lijekovima koji mogu produljiti QT interval i/ili u bolesnika s već prisutnim čimbenicima rizika (bradikardija, kongenitalno produljeni QT interval, poremećaji elektrolita) (vidjeti dijelove 4.8 i 5.3).
How to take REYATAZ 
Kako uzimati REYATAZ
At least 5 to less than 15 
Najmanje 5 do manje od 15
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. 
Ako se prosudi da je kombinacija lijeka REYATAZ s inhibitorom protonske pumpe neizbježna, preporučuje se pažljiv klinički nadzor u kombinaciji s povišenjem doze lijeka REYATAZ na 400 mg uz 100 mg ritonavira; ne smije se prekoračiti doza inhibitora protonske pumpe koja je usporediva s dozom omeprazola od 20 mg.
Have the child drink the mixture. 
3. Dajte djetetu da popije mješavinu.
ERECTILE DYSFUNCTION PDE5 Inhibitors 
Inhibitori PDE5
The mechanism of interaction is CYP3A4 and UGT1A1 inhibition. 
Mehanizam interakcije je inhibicija enzima CYP3A4 i UGT1A1.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/267/012 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/267/012
The M184I/V substitution emerged in 5/26 REYATAZ/ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively. 
Supstitucija M184I/V bila je prisutna u 5 od 26 bolesnika u kojih liječenje lijekom REYATAZ s ritonavirom nije bilo virološki uspješno i 7 od 26 bolesnika u kojih liječenje lopinavirom/ritonavirom nije bilo virološki uspješno.
A safe and effective dose in combination with REYATAZ has not been established for sildenafil when used to treat pulmonary arterial hypertension. 
Nije ustanovljena sigurna i djelotvorna doza sidenafila u kombinaciji s lijekom REYATAZ kad se sildenafil primjenjuje za liječenje plućne arterijske hipertenzije.
Contents of the pack and other information What REYATAZ contains - The active substance is atazanavir. 
Što REYATAZ sadrži - Djelatna tvar je atazanavir.
The M184V substitution in reverse transcriptase, which confers resistance to lamivudine and emtricitabine, was detected in 2 subjects in the unboosted REYATAZ and 1 subject in the REYATAZ + ritonavir group. 
Supstitucija M184V u reverznoj transkriptazi, koja uzrokuje rezistenciju na lamivudin i emtricitabin, otkrivena je u
f Intent-to-treat analysis, with missing values considered as failures. 
f Analiza prema planiranom liječenju, a vrijednosti koje su nedostajale smatrale su se neuspjehom.
Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.8). 
Redovito praćenje bubrežnih funkcija u bolesnika, treba se održavati tijekom cijelog trajanja liječenja (vidjeti dio 4.8).
Rifabutin AUC ↑48% (↑19% ↑84%) Rifabutin Cmax ↑149% (↑103% ↑206%) Rifabutin Cmin ↑40% (↑5% ↑87%) ** 25-O-desacetyl-rifabutin AUC ↑990% 25-O-desacetyl-rifabutin Cmax ↑677% 25-O-desacetyl-rifabutin Cmin ↑1045% 
Rifabutin AUC ↑48% (↑19% ↑84%) Rifabutin Cmax ↑149% (↑103% ↑206%) Rifabutin Cmin ↑40% (↑5% ↑87%) ** 25-O-dezacetil-rifabutin AUC ↑990% 25-O-dezacetil -rifabutin Cmax ↑677% 25-O-dezacetil -rifabutin Cmin ↑1045%
The most frequently reported laboratory abnormalities in paediatric patients receiving REYATAZ 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 REYTAZ oralni prašak bilo je povišenje ukupnog bilirubina (≥ 2,6 GGN, 3.-4. stupanj; 16%) i povišena vrijednost amilaze (3-4; stupanj33%), općenito porijekla koje nije povezano s gušteračom.
No dosage adjustment is necessary if methadone is coadministered with REYATAZ. 
Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s lijekom REYATAZ.
15 to less than 35 at least 35 
15 do manje od 35 najmanje 35
REYATAZ/ritonavirb (300 mg/100 mg once daily) n=440 
REYATAZ/ritonavirb (300 mg/100 mg jedanput na dan) n=440
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.