FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not recommended to use REYATAZ with ritonavir for pregnant patients who are receiving both tenofovir disoproxil and an H2-receptor antagonist.
Croatian: Ne preporučuje se primjenjivati REYATAZ s ritonavirom u trudnica koje primaju i tenofovirdizoproksil i antagonist
English: The REYATAZ/ritonavir arm has similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48: 78% of patients on REYATAZ/ritonavir compared to 76% on lopinavir/ritonavir (difference estimate of ATV/RTV-LPV/RTV: 1.7% [95% CI, -3.8%, 7.1%] according to the Confirmed Virologic Response (CVR) Non-Completer = Failure (NC = F) definition of response.
Croatian: Skupina koja je primala REYATAZ/ritonavir ima sličnu (inferiornu ) antivirusnu djelotvornost u usporedbi sa skupinom koja je primala lopinavir/ritonavir, kako je procijenjeno prema udjelu bolesnika s HIV RNK<50 kopija /ml u 48. tjednu:78% bolesnika na terapiji lijekom REYATAZ/ritonavirom u usporedbi s 76% na terapiji lopinavirom /ritonavirom (procjena razlike ATV/RTV-LPV/RTV: 1,7% [95% CI, -3.8%, 7,1%] prema definiciji odgovora.potvrđeni virološki odgovor (engl.
English: Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with REYATAZ.
Croatian: Snižene koncentracije atazanavira u plazmi mogu biti posljedica povišenog želučanog pH ako se antacidi, uključujući puferirane lijekove, primjenjuju s lijekom REYATAZ.
English: Co-administration of REYATAZ with these medicinal products is expected to substantially increase their concentrations and may result in PDE5-associated adverse reactions such as hypotension, visual changes and priapism (see section 4.5).
Croatian: Pri istovremenoj primjeni lijeka REYATAZ i ovih lijekova očekuje se znatno povećanje njihove koncentracije, što može rezultirati nuspojavama povezanima s PDE5, kao što su hipotenzija, poremećaji vida i prijapizam (vidjeti dio 4.5).
English: Didanosine (with food) Didanosine AUC ↓34% (↓41% ↓27%) Didanosine Cmax ↓38% (↓48% ↓26%) Didanosine Cmin ↑25% (↓8% ↑69%)
Croatian: Didanozin (s hranom) Didanozin AUC ↓34% (↓41% ↓27%) Didanozin Cmax ↓38% (↓48% ↓26%) Didanozin Cmin ↑25% (↓8% ↑69%)
English: When REYATAZ and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
Croatian: Kod istovremene primjene lijeka REYATAZ i ritonavira može prevladavati metabolički profil interakcija za ritonavir, zato što je ritonavir jači inhibitor enzima CYP3A4 od atazanavira.
English: Absorption: in HIV-infected patients (n=33, combined studies), multiple dosing of REYATAZ 300 mg once daily with ritonavir 100 mg once daily with food produced a geometric mean (CV%) for atazanavir, Cmax of 4466 (42%) ng/ml, with time to Cmax of approximately 2.5 hours.
Croatian: Apsorpcija: U bolesnika zaraženih HIV-om (n=33, kombinirana ispitivanja), višestruka primjena lijeka REYATAZ 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan s hranom dovela je do geometrijske sredine (CV%) Cmax atazanavira od 4466 (42%) ng/ml, uz vrijeme do postizanja Cmax od približno 2,5 sati.
English: Interactions with other medicinal products The combination of REYATAZ with atorvastatin is not recommended (see section 4.5).
Croatian: Interakcije s drugim lijekovima Ne preporučuje se istovremena primjena lijeka REYATAZ s atorvastatinom (vidjeti dio 4.5).
English: uncommon: torsades de pointesa rare: QTc prolongationa, oedema, palpitation
Croatian: manje često: torsades de pointesa rijetko: produljenje QTc intervalaa, edem, palpitacije
English: Carton Bottle pack (1 bottle): 30 hard capsules Carton Bottle pack: (3 bottles): 3 x 30 hard capsules (3 bottles of 30 hard capsules) Label Bottle pack: 30 hard capsules
Croatian: Kutija s bocom u pakiranju (1 boca): 30 tvrdih kapsula Kutija s bocama u pakiranju: (3 boce): 3 x 30 tvrdih kapsula (3 boce, svaka s 30 tvrdih kapsula)
English: Voriconazole AUC ↑561% (↑451% Voriconazole Cmax ↑438% (↑355% Voriconazole Cmin ↑765% (↑571%
Croatian: Vorikonazol AUC ↑561% (↑451% Vorikonazol Cmax ↑438% (↑355% Vorikonazol Cmin ↑765% (↑571%
English: Time-averaged difference ATV/RTV-LPV/RTV [97.5% CId] Week 48 Week 96 Week 48 Week 96 Week 48 Week 96 HIV RNA Mean Change from Baseline, log10 copies/ml
Croatian: Vremenski uprosječena razlika ATV/RTVLPV/RTV [97,5% CId] 48. tjedan 96. tjedan 48. tjedan 96. tjedan 48. tjedan 96. tjedan HIV RNK prosječna promjena od početne vrijednosti, log10 kopija/ml
English: No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg. the need to consider that co-administration of voriconazole and REYATAZ without ritonavir may affect atazanavir concentrations co-administration of fluticasone and REYATAZ without ritonavir may increase fluticasone concentrations relative to fluticasone given alone if an oral contraceptive is administered with REYATAZ without ritonavir, it is recommended that the oral contraceptive contain no more than 30 µg of ethinyloestradiol no dose adjustment of lamotrigine is required
Croatian: Treba imati na umu da: istovremena primjena vorikonazola i lijeka REYATAZ bez ritonavira može utjecati na koncentracije atazanavira; istovremena primjena flutikazona i lijeka REYATAZ bez ritonavira može povisiti koncentracije flutikazona u odnosu na koncentracije flutikazona primijenjenog samostalno, ako se istovremeno s lijekom REYATAZ bez ritonavira primjenjuje oralni kontraceptiv, preporučuje se da oralni kontraceptiv ne sadrži više od 30 µg etinilestradiola,
English: Methadone, stable maintenance dose (atazanavir 400 mg once daily)
Croatian: Metadon, stabilna doza održavanja (atazanavir 400 mg jedanput na dan)
English: Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving REYATAZ (see section 4.8).
Croatian: U bolesnika koji su primali REYATAZ nastupilo je reverzibilno povišenje indirektnog (nekonjugiranog) bilirubina povezano s inhibicijom UDP-glukuronozil transferaze (UGT) (vidjeti dio 4.8).
English: Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of REYATAZ/ritonavir with these medicinal products is not expected to significantly alter the exposure of the coadministered medicinal products.
Croatian: Na temelju ovih podataka i budući da se ne očekuje značajan učinak ritonavira na farmakokinetiku NRTI-jeva, ne očekuje se da će istovremena primjena ovih lijekova i lijeka REYATAZ/ritonavira značajno promijeniti izloženost tim istovremeno primijenjenim lijekovima.
English: Co-administration with REYATAZ may cause a large increase in the concentration of these benzodiazepines.
Croatian: Istovremena primjena lijeka REYATAZ može jako povećati koncentracije ovih benzodiazepina.
English: common: rash; uncommon: erythemia multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation
Croatian: često: osip; manje često: multiformni eritema,b, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijekaa,b, medikamentozni osip s eozinofilijom i sistemskim simptomima (DRESS)a,b, angioedema urtikarija, alopecija, pruritus; rijetko: Stevens-Johnsonov sindrom a,b
English: Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of these medicinal products and REYATAZ is not expected to significantly alter the exposure of the co-administered medicinal products.
Croatian: Na temelju ovih podataka i budući da se ne očekuje značajan učinak ritonavira na farmakokinetiku NRTI-jeva, ne očekuje se da će istovremena primjena ovih lijekova i lijeka REYATAZ značajno promijeniti izloženost tim istovremeno primijenjenim lijekovima.
English: REYATAZ capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).
Croatian: REYATAZ kapsule, koje se primjenjuju istovremeno s niskom dozom ritonavira, indicirane su u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje odraslih i pedijatrijskih bolesnika u dobi od 6 godina i starijih, koji su zaraženi virusom HIV 1 (vidjeti dio 4.2).
English: REYATAZ capsules are available for paediatric patients at least 6 years of age who weigh at least 15 kg and who are able to swallow capsules (see Summary of Product Characteristics for REYATAZ
Croatian: REYATAZ kapsule dostupne su za pedijatrijske bolesnike u dobi od najmanje 6 godina starosti i tjelesne težine od najmanje 15 kg koji mogu progutati kapsule (vidjeti Sažetak opisa svojstava lijeka za REYATAZ kapsule).
English: The recommended dose of REYATAZ capsules is 300 mg once daily taken with ritonavir 100 mg once daily and with food.
Croatian: Preporučena doza REYATAZ kapsula je 300 mg jedanput na dan i uzima se s ritonavirom u dozi od 100 mg jedanput na dan i s hranom.
English: Co-administration with REYATAZ/ritonavir may cause a large increase in the concentration of these benzodiazepines.
Croatian: Istovremena primjena lijeka REYATAZ/ritonavira može jako povećati koncentracije ovih benzodiazepina.
English: Carton Bottle pack (1 bottle): 60 hard capsules Carton Bottle pack: (3 bottles): 3 x 60 hard capsules (3 bottles of 60 hard capsules) Label Bottle pack: 60 hard capsules
Croatian: Kutija s bocom u pakiranju (1 boca): 60 tvrdih kapsula Kutija s bocama u pakiranju: (3 boce):3 x 60 tvrdih kapsula (3 boce, svaka s 60 tvrdih kapsula) Naljepnica na boci:60 tvrdih kapsula
English: Total rifabutin and 25-O-desacetyl-rifabutin AUC ↑119% (↑78% ↑169%).
Croatian: AUC ukupnog rifabutina i 25-Odezacetil-rifabutina ↑119% (↑78%
English: Teл.
Croatian: Clare,
English: Among naive patients treated with REYATAZ 300 mg once daily with 100 mg ritonavir once daily for a median duration of 96 weeks, 48% had Grade 3-4 total bilirubin elevations (see section 4.4).
Croatian: Među bolesnicima koji prethodno nisu bili liječeni i primali su REYATAZ 300 mg jedanput na dan sa 100 mg ritonavira jedanput na dan tijekom srednjeg razdoblja od 96 tjedana, 48% imalo je povišenje ukupnog bilirubina 3.-4. stupnja (vidjeti dio4.4).
English: Unboosted REYATAZ must not be used in patients with severe hepatic impairment.
Croatian: Nepojačani REYATAZ ne smije se primjenjivati u bolesnika s teškim oštećenjem funkcije jetre.
English: Patients should be informed that dizziness has been reported during treatment with regimens containing REYATAZ (see section 4.8).
Croatian: Bolesnike treba obavijestiti da je tijekom liječenja protokolima koji sadrže lijek REYATAZ zabilježena omaglica (vidjeti dio 4.8).
English: Didanosine should be taken at the fasted state 2 hours after REYATAZ taken with food.
Croatian: Didanozin treba uzeti natašte 2 sata nakon uzimanja lijeka REYATAZ, koji se uzima s hranom.
English: grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination, and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)
Croatian: simvastatin i lovastatin (primjenjuju se za snižavanje kolesterola u krvi) lijekovi koji sadrže grazoprevir, ukljućujući fiksnu kombinaciju elbasvir/grazoprevir i fiksnu kombinaciju glekaprevir/pibrentasvir (koja se koristi u liječenju kronične infekcije virusom hepatitisa C)
English: Excipient with known effect: 82.18 mg of lactose per capsule.
Croatian: Pomoćna tvar s poznatim učinkom: 82,18 mg laktoze po kapsuli.
English: By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA < 400 copies/ml (< 50 copies/ml) in the REYATAZ + ritonavir arm and the lopinavir + ritonavir arm were 55% (40%) and 56% (46%), respectively.
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 55% (40%), a u skupini koja je primala lopinavir s ritonavirom 56% (46%).
English: Due to CYP3A4 inhibition by REYATAZ, concentrations of quetiapine are expected to increase.
Croatian: Budući da REYATAZ inhibira CYP3A4, očekuje se povećanje koncentracija kvetiapina.
English: Glecaprevir AUC : ↑553% (↑424% Glecaprevir Cmax : ↑306% (↑215% Glecaprevir Cmin : ↑1330% (↑885%
Croatian: Glecaprevir AUC: ↑553% (↑424% Glekaprevir Cmax: ↑306% (↑215% Glecaprevir Cmin : ↑1330% (↑885%
English: Orange vanilla flavour
Croatian: Aroma naranče i vanilije
English: Serious skin rash, including Stevens-Johnson syndrome, has been reported in patients taking REYATAZ.
Croatian: U bolesnika koji uzimaju REYATAZ zabilježen je ozbiljni kožni osip, uključujući Stevens-Johnsonov sindrom.
English: If the combination 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 (see section 4.4).
Croatian: Ako se prosudi da je ta kombinacija neizbježna, preporučuje se pažljiv klinički nadzor u kombinaciji s povišenjem doze lijeka REYATAZ na 400 mg sa 100 mg ritonavira; ne smiju se prekoračiti doze inhibitora protonske pumpe usporedive s dozom omeprazola od 20 mg (vidjeti dio 4.4).
English: A safe and effective dose in combination with REYATAZ/ritonavir has not been established for sildenafil when used to treat pulmonary arterial hypertension.
Croatian: Nije ustanovljena sigurna i djelotvorna doza sidenafila u kombinaciji s lijekom REYATAZ/ritonavirom kad se sildenafil primjenjuje za liječenje plućne arterijske hipertenzije.
English: LPV/RTVc (400 mg/ 100 mg twice daily) n=123
Croatian: LPV/RTVc (400 mg/ 100 mg dvaput na dan) n=123
English: Co-administration of REYATAZ and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Croatian: Ne preporučuje se istovremena primjena lijeka REYATAZ i lijekova koji induciraju CYP3A4 (vidjeti dijelove 4.3 i 4.5).
English: Through 48 weeks of treatment, the mean changes from baseline in HIV RNA levels for REYATAZ + ritonavir and lopinavir + ritonavir were similar (non-inferior).
Croatian: Nakon 48 tjedana liječenja, prosječna promjena razine HIV RNK u odnosu na početnu vrijednost uz REYATAZ s ritonavirom bila je slična (neinferiorna) onoj uz lopinavir s ritonavirom.
English: Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.4).
Croatian: Redovito praćenje bubrežnih funkcija u bolesnika, treba se održavati tijekom cijelog trajanja liječenja (vidjeti dio 4.4).
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Croatian: U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme započinjanja liječenja kombiniranom antiretrovirusnom terapijom (CART) može nastati upalna reakcija na asimptomatske ili rezidualne oportunističke patogene i prouzročiti ozbiljna klinička stanja ili pogoršanje simptoma.
English: Time-averaged difference ATV/RTV-LPV/RTV [97.5% CId] Week 48 Week 96 Week 48 Week 96 Week 48 Week 96 HIV RNA Mean Change from Baseline, log10 copies/ml All patients
Croatian: Vremenski uprosječena razlika ATV/RTVLPV/RTV [97,5% CId] 48. tjedan 96. tjedan 48. tjedan 96. tjedan 48. tjedan 96. tjedan HIV RNK prosječna promjena u odnosu na početnu vrijednost, log10 kopija/ml Svi bolesnici
English: REYATAZ 50 mg oral powder atazanavir
Croatian: REYATAZ 50 mg oralni prašak atazanavir
English: If the co-administration of REYATAZ with an NNRTI is required, an increase in the dose of both REYATAZ and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
Croatian: Ako je potrebno istovremeno primjenjivati REYATAZ s nekim NNRTI-jem, može se razmotriti povišenje doze lijeka REYATAZ na 400 mg i ritonavira na 200 mg u kombinaciji s efavirenzom, uz pažljivo praćenje bolesnika.
English: * When compared to REYATAZ 300 mg and ritonavir 100 mg without nevirapine.
Croatian: * Kad se uspoređivao s lijekom REYATAZ 300 mg/ritonavir 100 mg bez nevirapina.
English: Combination of rifampicin (see section 4.5).
Croatian: Kombinacija s rifampicinom. (vidjeti dio 4.5).
English: Co-administration of REYATAZ with voxilaprevircontaining products is expected to increase the concentration of voxilaprevir.
Croatian: Očekuje se da istodobna primjena lijeka REYATAZ s lijekovima koji sadrže voksilaprevir povećava koncentraciju voksilaprevira.
English: HCV Protease Inhibitors
Croatian: Inhibitori proteaze HCV-a
English: Excipient with known effect: 164.36 mg of lactose per capsule.
Croatian: Pomoćna tvar s poznatim učinkom: 164,36 mg laktoze po kapsuli.
English: 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.
Croatian: 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.
English: REYATAZ with ritonavir should be used with caution in patients with mild hepatic impairment.
Croatian: REYATAZ s ritonavirom treba primjenjivati s oprezom u bolesnika s blagim oštećenjem funkcije jetre.
English: No dosage adjustment is necessary if methadone is coadministered with REYATAZ and ritonavir.
Croatian: Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s lijekom REYATAZ i ritonavirom.
English: 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).
Croatian: 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).
English: MARKETING AUTHORISATION NUMBER(S) Bottle pack
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pakiranje s bocom
English: 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).
Croatian: 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).
English: How to take REYATAZ
Croatian: Kako uzimati REYATAZ
English: At least 5 to less than 15
Croatian: Najmanje 5 do manje od 15
English: 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.
Croatian: 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.
English: Have the child drink the mixture.
Croatian: 3. Dajte djetetu da popije mješavinu.
English: ERECTILE DYSFUNCTION PDE5 Inhibitors
Croatian: Inhibitori PDE5
English: The mechanism of interaction is CYP3A4 and UGT1A1 inhibition.
Croatian: Mehanizam interakcije je inhibicija enzima CYP3A4 i UGT1A1.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/267/012
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/267/012
English: The M184I/V substitution emerged in 5/26 REYATAZ/ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Croatian: 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.
English: A safe and effective dose in combination with REYATAZ has not been established for sildenafil when used to treat pulmonary arterial hypertension.
Croatian: Nije ustanovljena sigurna i djelotvorna doza sidenafila u kombinaciji s lijekom REYATAZ kad se sildenafil primjenjuje za liječenje plućne arterijske hipertenzije.
English: Contents of the pack and other information What REYATAZ contains - The active substance is atazanavir.
Croatian: Što REYATAZ sadrži - Djelatna tvar je atazanavir.
English: 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.
Croatian: Supstitucija M184V u reverznoj transkriptazi, koja uzrokuje rezistenciju na lamivudin i emtricitabin, otkrivena je u
English: f Intent-to-treat analysis, with missing values considered as failures.
Croatian: f Analiza prema planiranom liječenju, a vrijednosti koje su nedostajale smatrale su se neuspjehom.
English: Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.8).
Croatian: Redovito praćenje bubrežnih funkcija u bolesnika, treba se održavati tijekom cijelog trajanja liječenja (vidjeti dio 4.8).
English: 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%
Croatian: 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%
English: 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.
Croatian: 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.
English: No dosage adjustment is necessary if methadone is coadministered with REYATAZ.
Croatian: Nije potrebna prilagodba doze ako se metadon primjenjuje istovremeno s lijekom REYATAZ.
English: 15 to less than 35 at least 35
Croatian: 15 do manje od 35 najmanje 35
English: REYATAZ/ritonavirb (300 mg/100 mg once daily) n=440
Croatian: REYATAZ/ritonavirb (300 mg/100 mg jedanput na dan) n=440
English: 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).
Croatian: 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).
English: ATV/RTVb (300 mg/ 100 mg once daily) n=120
Croatian: ATV/RTVb (300 mg/ 100 mg jedanput na dan) n=120