FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2blockers.
Croatian: Mehanizam interakcije je smanjenje topljivosti atazanavira s povećanjem želučanog pH zbog H2 blokatora.
English: 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%).
Croatian: 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%).
English: BRISTOL-MYERS SQUIBB, S.A. Tel: + 34 91 456 53 00
Croatian: SQUIBB, S.A. Tel: + 34 91 456 53 00
English: Eleven subjects (13%) in the unboosted REYATAZ group and 6 (7%) in the REYATAZ + ritonavir group, had virologic rebound.
Croatian: U jedanaest ispitanika (13%) u skupini liječenoj nepojačanim lijekom REYATAZ i 6 (7%) ispitanika u skupini koja je primala REYATAZ
English: Studies conducted in HIVinfected patients.
Croatian: Ispitivanja provedena u bolesnika s HIV-infekcijom.
English: No dosage adjustments are needed for fluconazole and REYATAZ.
Croatian: Nisu potrebne prilagodbe doze flukonazola i lijeka REYATAZ.
English: 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.
Croatian: 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.
English: White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Croatian: Bijela tinta sadrži: šelak, titanijev dioksid (E171), amonijev hidroksid, propilenglikol i simetikon 6.2 Inkompatibilnosti
English: LIST OF EXCIPIENTS Contains aspartame and sucrose.
Croatian: 3. POPIS POMOĆNIH TVARI Sadrži aspartam i saharozu.
English: (See section 4.4 Withdrawal of ritonavir only under restrictive conditions).
Croatian: "Prekid primjene ritonavira samo pod restriktivnim uvjetima" ).
English: Due to carbamazepine inducing effect, a reduction in REYATAZ/ritonavir exposure cannot be ruled out.
Croatian: Zbog inducirajućeg učinka karbamazepina, ne može se isključiti smanjena izloženost lijeku REYATAZ/ritonaviru.
English: common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitisa
Croatian: često: žutica; manje često: hepatitis, kolelitijazaa, kolestazaa; rijetko: hepatosplenomegalija, kolecistitis a
English: Co-administration of simvastatin or lovastatin with REYATAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Croatian: Kontraindicirana je istovremena primjena simvastatina ili lovastatina s lijekom REYATAZ zbog povišenog rizika od miopatije uključujući rabdomiolizu (vidjeti dio 4.3).
English: d Ritonavir oral solution or capsule/tablet.
Croatian: c Ritonavir oralna otopina d Ritonavir oralna otopina ili kapsule/tablete
English: SEDATIVES Benzodiazepines
Croatian: Benzodiazepini
English: Co-administration of REYATAZ with proton pump inhibitors is not recommended (see section 4.5).
Croatian: Ne preporučuje se istovremena primjena lijeka REYATAZ s inhibitorima protonske pumpe (vidjeti dio 4.5).
English: Co-administration of REYATAZ with ritonavir and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Croatian: Ne preporučuje se istovremena primjena lijeka REYATAZ s ritonavirom i lijekova koji induciraju CYP3A4 (vidjeti dijelove 4.3 i 4.5).
English: Each capsule of REYATAZ 300 mg contains 300 mg atazanavir.
Croatian: Jedna kapsula REYATAZ 300 mg sadrži 300 mg atazanavira.
English: Each sachet of REYATAZ 50 mg oral powder contains 50 mg atazanavir.
Croatian: Jedna vrećica REYATAZ 50 mg oralnog praška sadrži 50 mg atazanavira.
English: Patients with moderate to severe hepatic insufficiency (see sections 4.2 and 4.4).
Croatian: Bolesnici s umjerenom do teškom insuficijencijom jetre (vidjeti dijelove 4.2 i 4.4).
English: Excipient with known effect: 109.57 mg of lactose per capsule.
Croatian: Pomoćna tvar s poznatim učinkom: 109,57 mg laktoze po kapsuli.
English: Combinations of REYATAZ and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Croatian: Kombinacije lijeka REYATAZ i indinavira nisu ispitane pa se ne preporučuje njihova istovremena primjena (vidjeti dio 4.5).
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily (atazanavir 400 mg once daily)
Croatian: 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)
English: Ethinyloestradiol AUC ↑48% (↑31% Ethinyloestradiol Cmax ↑15% (↓1% Ethinyloestradiol Cmin ↑91% (↑57%
Croatian: Etinilestradiol AUC ↑48% (↑31% Etinilestradiol Cmax ↑15% (↓1% ↑32%) Etinilestradiol Cmin ↑91% (↑57%
English: Belgique/België/Belgien N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Croatian: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: 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.
Croatian: 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.
English: Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ.
Croatian: Kinidin ima uzak terapijski raspon i kontraindiciran je zbog moguće inhibicije enzima CYP3A lijekom REYATAZ.
English: Ethinyloestradiol AUC ↓19% (↓25% Ethinyloestradiol Cmax ↓16% (↓26% Ethinyloestradiol Cmin ↓37% (↓45%
Croatian: Etinilestradiol AUC ↓19% (↓25% Etinilestradiol Cmax ↓16% (↓26% ↓5%) Etinilestradiol Cmin ↓37% (↓45%
English: 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%
Croatian: 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%
English: Co-administration with REYATAZ/ritonavir has the potential to produce a decrease or, less often, an increase in INR (International Normalised Ratio).
Croatian: Istovremena primjena s lijekom REYATAZ /ritonavirom može dovesti do sniženja ili rjeđe povišenja međunarodno normaliziranog omjera (INR).
English: NA
Croatian: a
English: 6.6 Special precautions for disposal and other handling Instructions for use:
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: PHARMACEUTICAL FORM Oral powder
Croatian: OBLIK Oralni prašak.
English: The co-administration of abacavir and REYATAZ is not expected to significantly alter the exposure of abacavir.
Croatian: Ne očekuje se da će istovremena primjena abakavira i lijeka REYATAZ značajno promijeniti izloženost abakaviru.
English: 100 to <200 cells/mm3
Croatian: 100 do <200 stanica /mm3
English: Co-administration of REYATAZ with nevirapine or efavirenz is not recommended (see section 4.5).
Croatian: Ne preporučuje se istovremena primjena lijeka REYATAZ s nevirapinom ili efavirenzom (vidjeti dio 4.5).
English: ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Croatian: ANTIBIOTICI Klaritromicin 500 mg dvaput na dan (atazanavir 400 mg jedanput na dan)
English: These are listed under Do not take REYATAZ, at the start of Section 2.
Croatian: Ti su lijekovi navedeni na početku dijela 2, ispod podnaslova
English: 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.
Croatian: 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.
English: No drug interaction study has been performed for the coadministration of REYATAZ with benzodiazepines.
Croatian: Nisu provedena ispitivanja interakcija lijekova kod istovremene primjene lijeka REYATAZ i benzodiazepina.
English: 50 to <100 cells/mm3
Croatian: 50 do <100 stanica /mm3
English: The combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Croatian: Kombinacija rifampicina i lijeka REYATAZ s istovremeno primijenjenom niskom dozom ritonavira je kontraindicirana (vidjeti dio 4.3).
English: Antiretroviral treatment naive adult patients
Croatian: Antiretrovirusno liječenje prethodno liječenih bolesnika
English: Four subjects in the unboosted REYATAZ group and 2 in the REYATAZ + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
Croatian: + ritonavir imala su HIV RNK > 500 kopija/ml tijekom faze održavanja.
English: Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
Croatian: Fenobarbital i fenotoin se moraju primjenjivati uz oprez u kombinaciji s lijekom REYATAZ i ritonavirom.
English: 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)
Croatian: 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)
English: Concomitant use of St. John's wort with REYATAZ/ritonavir may be expected to result in significant reduction in plasma levels of atazanavir.
Croatian: Može se očekivati da istovremena primjena gospine trave i lijeka REYATAZ/ritonavira rezultira značajnim sniženjem razine atazanavira u plazmi.
English: Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with REYATAZ/ritonavir may result in increased concentrations.
Croatian: Metabolizam simvastatina i lovastatina jako ovisi o enzimu CYP3A4 i istovremena primjena s lijekom REYATAZ/ritonavirom može rezultirati povišenim koncentracijama.
English: Effect on atazanavir and ritonavir exposure has not been studied.
Croatian: Nije ispitivan utjecaj na izloženost atazanaivru i ritonaviru.
English: Excipient with known effect: 54.79 mg of lactose per capsule.
Croatian: Pomoćna tvar s poznatim učinkom: 54,79 mg laktoze po kapsuli.
English: 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.
Croatian: 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.
English: An additional 15 ml of beverage is added to the drinking cup for thorough rinsing of the cup and contents are mixed.
Croatian: Dodatnih 15 ml pića se dodaje u čašu kako bi se isprao ostatak u šalici.
English: 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).
Croatian: 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).
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between REYATAZ and comparator regimens (see section 4.4).
Croatian: 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).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: Due to carbamazepine inducing effect, a reduction in REYATAZ exposure cannot be ruled out.
Croatian: Zbog inducirajućeg učinka karbamazepina, ne može se isključiti smanjena izloženost lijeku REYATAZ.
English: 3) and mean baseline plasma HIV-1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
Croatian: 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).
English: Due to phenytoin/phenobarbital inducing effect, a reduction in REYATAZ exposure cannot be ruled out.
Croatian: Zbog inducirajućeg učinka fenitoina/fenobarbitala, ne može se isključiti smanjena izloženost lijeku REYATAZ.
English: REYATAZ/ritonavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5associated adverse events, including hypotension, visual changes, and priapism.
Croatian: REYATAZ/ritonavirom može rezultirati povišenim koncentracijama inhibitora PDE5 i pojačanim nuspojavama povezanima s PDE5, uključujući hipotenziju, poremećaje vida i prijapizam.
English: Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated (see section 4.3).
Croatian: Sildenafil je kontraindiciran kad se primjenjuje za liječenje plućne arterijske hipertenzije (vidjeti dio 4.3).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REYATAZ 50 mg ORAL POWDER - FOIL SACHET 1.
Croatian: 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
English: No drug interaction study has been performed for the co-administration of REYATAZ/ritonavir with benzodiazepines.
Croatian: Nisu provedena ispitivanja interakcija lijekova kod istovremene primjene lijeka REYATAZ/ritonavira i benzodiazepina.
English: 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).
Croatian: REYATAZ oralni prašak mogu uzimati djeca u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg (pogledajte dio 3.
English: Carbamazepine should be used with caution in combination with REYATAZ.
Croatian: Karbamazepin se mora primjenjivati uz oprez u kombinaciji s lijekom REYATAZ.
English: 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.
Croatian: 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.
English: However, REYATAZ is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
Croatian: Međutim, REYATAZ se ne preporučuje u bolesnika na hemodijalizi (vidjeti dijelove 4.2 i 5.2).
English: 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.
Croatian: 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.
English: 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
Croatian: 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
English: Before use, tap the sachet.
Croatian: 2. Prije primjene protresite vrećicu.
English: Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with REYATAZ may result in increased concentrations.
Croatian: Metabolizam simvastatina i lovastatina jako ovisi o enzimu CYP3A4 i istovremena primjena s lijekom REYATAZ može rezultirati povišenim koncentracijama.
English: Co-administration of the PDE5 inhibitor sildenafil when used for the treatment of pulmonary arterial hypertension (PAH) only (see section 4.5).
Croatian: Istovremena primjena inhibitora PDE5, sildenafila, samo kad se primjenjuje za liječenje plućne arterijske hipertenzije (PAH) (vidjeti dio 4.5).
English: Co-administration of REYATAZ with ritonavir and proton pump inhibitors is not recommended.
Croatian: Ne preporučuje se istovremena primjena lijeka REYATAZ s ritonavirom i inhibitorima protonske pumpe.
English: Norgestimate AUC ↑85% (↑67% Norgestimate Cmax ↑68% (↑51% Norgestimate Cmin ↑102% (↑77%
Croatian: Norgestimat AUC ↑85% (↑67% Norgestimat Cmax ↑68% (↑51% ↑88%) Norgestimat Cmin ↑102% (↑77%
English: Grazoprevir concentrations were greatly increased when co-administered with atazanavir/ritonavir.
Croatian: Koncentracije grazoprevira su značajno porasle kada je primjenjivan istodobno s atazanavirom/ritonavirom.
English: Concomitant use of St. John's wort with REYATAZ may be expected to result in significant reduction in plasma levels of atazanavir.
Croatian: Može se očekivati da istovremena primjena gospine trave i lijeka REYATAZ rezultira značajnim sniženjem razine atazanavira u plazmi.
English: Norethindrone AUC ↑110% (↑68% Norethindrone Cmax ↑67% (↑42% Norethindrone Cmin ↑262% (↑157%
Croatian: Noretindron AUC ↑110% (↑68% Noretindron Cmax↑67% (↑42% Noretindron Cmin ↑262% (↑157%
English: A change in dose may occur when switching between oral powder and capsules.
Croatian: Kod prelaska na kapsule s oralnog praška može se dogoditi i promjena doze.
English: 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.
Croatian: 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.
English: Atazanavir, the active substance of REYATAZ, is excreted in human milk.
Croatian: Atazanavir, djelatna tvar lijeka REYATAZ izlučuje se u majčino mlijeko.
English: Voriconazole AUC ↓33% (↓42% Voriconazole Cmax ↓10% (↓22% ↓4%) Voriconazole Cmin ↓39% (↓49% ↓28%)
Croatian: Vorikonazol AUC ↓33% (↓42% Vorikonazol Cmax ↓10% (↓22% ↓4%) Vorikonazol Cmin ↓39% (↓49% ↓28%)
English: 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).
Croatian: 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).
English: Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ.
Croatian: Koncentracije ovih antiaritmika mogu biti povišene kad se primjenjuju istovremeno s lijekom REYATAZ.
English: Treatment-Experienced REYATAZ Powder/ritonavir n=82
Croatian: Bolesnici koji su prethodno bili liječeni REYATAZ oralnim prašakom /ritonavirom n=82
English: Buprenorphine, once daily, stable maintenance dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Croatian: Buprenorfin, jedanput na dan, stabilna doza održavanja (atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Croatian: 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)
English: * When compared to REYATAZ 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
Croatian: * Kad je uspoređivan s lijekom REYATAZ 300 mg/ritonavir 100 mg jedanput na dan, navečer, bez efavirenza.
English: The combination of rifampicin and REYATAZ is contraindicated (see section 4.3).
Croatian: Kombinacija rifampicina i lijeka REYATAZ je kontraindicirana (vidjeti dio 4.3).
English: Concomitant use of salmeterol and REYATAZ/ritonavir may result in increased cardiovascular adverse events associated with salmeterol.
Croatian: Istovremena primjena salmeterola i lijeka REYATAZ/ritonavira može rezultirati pojačanim kardiovaskularnim nuspojavama salmeterola.
English: a Intent-to-treat analysis, with missing values considered as failures.
Croatian: a Analiza prema planiranom liječenju, s time da su se vrijednosti koje su nedostajale smatrale neuspjehom.
English: Co-administration of lurasidone with REYATAZ is contrandicated as this may increase lurasidone-related toxicity (see section 4.3).
Croatian: Istodobna primjena lurasidona i lijeka REYATAZ je kontraindicirana, jer može povećati toksičnost povezanu s primjenom lurasidona (vidjeti dio 4.3.).
English: Bristol-Myers Squibb Pharma EEIG
Croatian: SQUIBB PHARMA EEIG
English: 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)
Croatian: 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
English: Co-administration with REYATAZ/ritonavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5inhibitor-associated adverse events.
Croatian: Istovremena primjena s lijekom REYATAZ/ritonavirom može rezultirati povišenim koncentracijama inhibitora PDE5 i pojačanim nuspojavama povezanima s inhibitorom PDE5.
English: d Intent-to-treat analysis, with missing values considered as failures.
Croatian: d Analiza prema planiranom liječenju, s time da su se vrijednosti koje su nedostajale smatrale neuspjehom.
English: Co-administration of lurasidone with REYATAZ is contraindicated as this may incrrease lurasidone-related toxicity (see section 4.3)
Croatian: Istodobna primjena lurasidona i lijeka REYATAZ je kontraindicirana, jer može povećati toksičnost povezanu s primjenom lurasidona (vidjeti dio 4.3.)
English: Dose related asymptomatic prolongations in PR interval with REYATAZ have been observed in clinical studies.
Croatian: U kliničkim je ispitivanjima opaženo asimptomatsko produljenje PR intervala povezano s dozom lijeka REYATAZ.
English: Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving REYATAZ should be evaluated for alternative aetiologies.
Croatian: Potrebno je provjeriti alternativne uzroke povišenja jetrenih transaminaza koje može nastati uz povišenje bilirubina u bolesnika koji primaju REYATAZ.
English: BRISTOL-MYERS SQUIBB S.R.L.
Croatian: SQUIBB S.R.L.
English: Cholelithiasis has been reported in patients receiving REYATAZ (see section 4.8).
Croatian: U bolesnika koji primaju REYATAZ zabilježena je kolelitijaza (vidjeti dio 4.8).