natgillin/translations-raw huggingface dataset:
Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis. 
Bolesnici istovremeno zaraženi virusom hepatitisa B ili C Od 1151 bolesnika koji su primali atazanavir 400 mg jedanput na dan, 177 bolesnika istovremeno je imalo kroničnu infekciju virusom hepatitisa B ili C, dok je od 655 bolesnika koji su primali atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan, 97 bolesnika istovremeno imalo kroničnu infekciju virusom B ili C.
Study conducted in HIV infected patients 
Ispitivanja provedena u bolesnika s HIV-infekcijom
In case of withdrawal of ritonavir from the initial recommended ritonavir boosted regimen (see section 4.4), unboosted REYATAZ could be maintained in patients with mild hepatic impairment at a dose of 400 mg, and in patients with moderate hepatic impairment with a reduced dose of 300 mg once daily with food (see section 5.2). 
U slučaju izostavljanja ritonavira iz početnog preporučenog režima pojačanog ritonavirom (vidjeti dio 4.4), nepojačani REYATAZ može se nastaviti primjenjivati u boelsnika s blagim oštećenjem jetre u dozi od 400 mg, a u bolesnika s umjerenim oštećenjem funkcije jetre doza se mora smanjiti na 300 mg jedanput na dan i uzimati s hranom (vidjeti dio 5.2).
SPECIAL STORAGE CONDITIONS Does not require any special storage conditions. 
Ne zahtijeva posebne uvjete čuvanja.
Alternative antiretroviral therapy to REYATAZ may be considered if jaundice or scleral icterus is unacceptable to a patient. 
Može se razmotriti primjena drugih antiretrovirusnih lijekova ako su žutilo kože ili sklera bolesniku neprihvatljivi.
B: To mix the recommended number of REYATAZ oral powder sachets with a beverage such as milk or water in a small drinking cup: A spoon is used to mix the content of the sachets with 30 ml of the beverage. 
B: Za miješanje preporučenog broja vrećica REYATAZ oralnog praška s pićem kao što je mlijeko ili voda u maloj čaši: Žlica se koristi kako bi se promiješao sadržaj vrećica s 30 ml pića.
Integrase Inhibitors Raltegravir 400 mg twice daily (atazanavir/ritonavir) 
Inhibitori integraze Raltegravir 400 mg dvaput na dan (atazanavir/ritonavir)
REYATAZ has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving REYATAZ 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or REYATAZ 300 mg with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration). 
Sigurnost lijeka REYATAZ procijenjena je u kombiniranoj terapiji s drugim antiretrovirusnim lijekovima u kontroliranim kliničkim ispitivanjima u 1806 odraslih bolesnika koji su primali REYATAZ 400 mg jedanput na dan (1151 bolesnika, srednje trajanje liječenja 52 tjedna i maksimalno trajanje liječenja 152 tjedna) ili REYATAZ 300 mg s ritonavirom 100 mg jedanput na dan (655 bolesnika, srednje trajanje liječenja 96 tjedana i maksimalno trajanje liječenja 108 tjedana).
The child is to drink the entire residual mixture. 
Dijete treba popiti u potpunosti preostali dio mješavine.
The clinical data derived from this study are inadequate to support the use of atazanavir capsules (with or without ritonavir) in children below 6 years of age. 
Klinički podaci iz ovog ispitivanja nisu prikladni da bi se podržala primjena kapsula atazanavira (s ritonavirom ili bez njega) u djece mlađe od 6 godina.
For children who cannot eat solid food or drink from a cup, REYATAZ oral powder must be mixed with infant formula and should be given using an oral syringe. 
Kod djece koja ne mogu jesti krutu hranu ili piti iz čaše REYATAZ oralni prašak mora se pomiješati s dojenačkom formulom i potrebno ga je primijeniti koristeći oralnu štrcaljku.
Each carton contains 30 sachets. 
Jedna kutija sadrži 30 vrećica.
Preparing and giving the medicine with drinks 
Pripema i primjena lijeka s pićem
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk (see section 5.1). 
U bolesnika s već prisutnim poremećajima provođenja (atrioventrikularni blok drugog ili višeg stupnja ili kompletni blok grane) REYATAZ treba primjenjivati s oprezom i samo ako su koristi od liječenja veće od rizika (vidjeti dio 5.1).
Human experience of acute overdose with REYATAZ is limited. 
Iskustvo s akutnim predoziranjem lijekom REYATAZ u ljudi je ograničeno.
rare: hepatosplenomegaly, cholecystitis a 
rijetko: hepatosplenomegalija, kolecistitisa
Also see PULMONARY ARTERIAL HYPERTENSION in this table for further information regarding coadministration of REYATAZ with sildenafil. 
Vidjeti također PLUĆNA ARTERIJSKA HIPERTENZIJA u ovoj tablici za dodatne informacije o istovremenoj primjeni lijeka REYATAZ i sildenafila.
f Number of patients evaluable. 
f Broj bolesnika koji su se mogli procijeniti.
Paediatric trials with REYATAZ capsules 
Pedijatrijska ispitivanja s REYATAZ kapsulama
Through 96 weeks of treatment, mean HIV RNA changes from baseline for REYATAZ + ritonavir and lopinavir + ritonavir met criteria for non-inferiority based on observed cases. 
Nakon 96 tjedana liječenja, prosječna promjena razine HIV RNK u odnosu na početnu vrijednost uz REYATAZ s ritonavirom i lopinavir s ritonavirom zadovoljila je kriterij neinferiornosti na temelju opaženih slučajeva.
When given with REYATAZ, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday). 
Kad se daje s lijekom REYATAZ, preporučena doza rifabutina je 150 mg tri puta tjedno u određene dane (na primjer, ponedjeljak-srijedapetak).
≥ 200 cells/mm3 
≥ 200 stanica /mm3
Each carton contains 60 x 1 capsules; 10 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters. 
Jedna kutija sadrži 60 x 1 kapsulu; 10 blister kartica sa 6 x 1 kapsulom u perforiranom Al/Al blisteru djeljivom na pojedinačne doze.
REYATAZ is also available as an oral powder for use in children at least 3 months old and weighing at least 5 kg. 
REYATAZ je također dostupan u obliku oralnog praška za primjenu kod djece u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg.
PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving REYATAZ. 
Inhibitori PDE5 koji se primjenjuju za liječenje erektilne disfunkcije: potreban je poseban oprez kad se propisuju inhibitori PDE5 (sildenafil, tadalafil ili vardenafil) za liječenje erektilne disfunkcije u bolesnika koji primaju REYATAZ.
Each bottle contains 30 hard capsules. 
Jedna boca sadrži 30 tvrdih kapsula.
Didanosine should be taken at the fasted state 2 hours after REYATAZ/ritonavir taken with food. 
Didanozin treba uzeti natašte 2 sata nakon uzimanja lijeka REYATAZ/ritonavira koji se uzima s hranom.
In HIV-infected patients (n=13), multiple dosing of REYATAZ 400 mg (without ritonavir) once daily with food produced a geometric mean (CV%) for atazanavir Cmax of 2298 (71) ng/ml, with time to Cmax of approximately 2.0 hours. 
U bolesnika zaraženih HIV-om (n=13), višestruka primjena lijeka REYATAZ u dozi od 400 mg (bez ritonavira) jedanput na dan s hranom dovela je do geometrijske srednje vrijednosti (CV%) Cmax atazanavira od 2298 (71) ng/ml, uz vrijeme do postizanja Cmax od približno 2,0 sati.
80 mgc at least 35 
80 mgc najmanje 35
The use of REYATAZ in children less than 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications. 
Primjena lijeka REYATAZ u djece mlađe od 3 mjeseca i tjelesne težine manje od 5kg nije ispitana zbog rizika od pojave ozbiljnih komplikacija.
Talk to your doctor immediately if you get symptoms of kidney stones which may include, pain in your low back or low stomach-area, blood in your urine or pain when you urinate. 
Odmah se obratite liječniku ako razvijete simptome bubrežnih kamenaca mogu uključivati bol u donjem dijelu leđa ili donjem dijelu trbuha, krv u mokraći ili bol pri mokrenju.
QUALITATIVE AND QUANTITATIVE COMPOSITION REYATAZ 100 mg hard capsules 
2. KVALITATIVNI I KVANTITATIVNI SASTAV REYATAZ 100 mg tvrde kapsule
Buprenorphine AUC ↑67% Buprenorphine Cmax ↑37% Buprenorphine Cmin ↑69% 
Buprenorfin AUC ↑67% Buprenorfin Cmax ↑37% Buprenorfin Cmin ↑69%
REYATAZ given without ritonavir should not be considered in patients treated with a backbone regimen containing tenofovir disoproxil and with other concomitant medications that reduce atazanavir bioavailability (see section 4.5 In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen) or in case of perceived challenging compliance. 
Primjena lijeka REYATAZ bez ritonavira ne smije se razmatrati u bolesnika liječenih osnovnim režimom koji sadrži tenofovirdizoproksil i drugim istovremeno primjenjivanim lijekovima koji smanjuju bioraspoloživost atazanavira (vidjeti odlomak "Ako se ritonavir izostavi iz preporučenog režima liječenja atazanavirom pojačanim ritonavirom" u dijelu 4.5), kao ni u bolesnika za koje se smatra da bi mogli imati poteškoća s pridržavanjem liječenja.
It is not known whether REYATAZ with ritonavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants. 
Nije poznato hoće li REYATAZ s ritonavirom primijenjen majci tijekom trudnoće pogoršati fiziološku hiperbilirubinemiju i dovesti do kernikterusa novorođenčeta i dojenčeta.
Concentrations of atazanavir were not significantly affected. 
Koncentracije atazanavira nisu bile značajno promijenjene.
Frequency de novo PI substitution (n=26)a none none a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml). 
Učestalost de novo supstitucija za rezistenciju na inhibitor proteaze (n=26)a nijedna nijedna a Broj bolesnika s uparenim genotipovima klasificiranih kao virološki neuspjeh (HIV RNK ≥ 400 kopija/ml).
LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Simvastatin 
Inhibitori reduktaze HMG-CoA Simvastatin
It is not known whether REYATAZ administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants. 
Nije poznato hoće li REYATAZ primijenjen majci tijekom trudnoće pogoršati fiziološku hiperbilirubinemiju i dovesti do kernikterusa novorođenčeta i dojenčeta.
g Select substitutions include any change at positions L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84, and L90 (0-2, 3, 4 or more) at baseline. 
g Odabrane supstitucije uključuju svaku promjenu na položajima: L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84 i L90 (0-2, 3, 4 ili više) na početku.
As a result, greater peak to trough ratios are observed, however at recommended doses, geometric mean atazanavir exposures (Cmin, Cmax and AUC) in paediatric patients are expected to be similar to those observed in adults. 
Kao posljedica, opaženi su veći omjeri vršnih i najnižih vrijednosti, no očekuje se da kod preporučenih doza, geometrijska srednja vrijednost i izloženosti atazanaviru (Cmin, Cmax i AUC) u pedijatrijskih bolesnika budu slična onoj primjećenoj u odraslih osoba.
postpartuma (n=36) 
Nakon porođajaa (n=36)
Put the oral syringe tip into the mixture and pull back the plunger until the full amount of infant formula is taken up. 
3. Stavite vrh oralne štrcaljke u mješavinu i povucite klip sve dok se puna količina dojenačke formule nije uvukla.
* In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28). 
* U kombiniranoj analizi, atazanavir 300 mg s ritonavirom 100 mg (n=33) uspoređen je s atazanavirom 400 mg bez ritonavira (n=28).
PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving REYATAZ with concomitant low-dose ritonavir. 
Inhibitori PDE5 koji se primjenjuju za liječenje erektilne disfunkcije: potreban je poseban oprez kad se propisuju inhibitori PDE5 (sildenafil, tadalafil ili vardenafil) za liječenje erektilne disfunkcije u bolesnika koji primaju REYATAZ s istovremenom primjenom niske doze ritonavira.
When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir, atazanavir concentrations are expected to be additionally decreased by about 20%. 
Kad se uspoređuje s atazanavirom 300 mg s ritonavirom 100 mg bez tenofovira, očekuje se da će koncentracije atazanavira biti dodatno smanjene za približno 20%.
A clean pair of scissors is used to cut each sachet along the dotted line. 
Treba upotrijebiti čiste škare i i odrezati vrećicu uz točkastu liniju.
REYATAZ should be administered 2 hours before or 1 hour after antacids or buffered medicinal products. 
REYATAZ treba primijeniti 2 sata prije ili 1 sat nakon antacida i puferiranih lijekova.
The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of REYATAZ/ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours. 
Smanjenje AUC, Cmax i Cmin nije bilo ublaženo privremenim vremenskim razmakom između povišene doze lijeka REYATAZ s ritonavirom (400/100 mg jedanput na dan) i omeprazola od 12 sati.
REYATAZ Dose once daily (mg) 
REYATAZ doza jedanput na dan (mg)
Ritonavir Dose* once daily (mg) 
Ritonavir doza* jedanput na dan (mg)
Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with REYATAZ (see section 4.4). 
Bolesnike treba upozoriti na ove moguće nuspojave kad se inhibitori PDE5 za erektilnu disfunkciju uzimaju istovremeno s lijekom REYATAZ (vidjeti dio 4.4).
Yellowing of the skin and/or eyes (jaundice) and irregular heart beat (QTc prolongation) may occur if you or your child take too much REYATAZ. 
Ako uzmete više lijeka REYATAZ nego što ste trebali Žutilo kože i/ili očiju (žutica) i nepravilni otkucaji srca (produženje QTc intervala) mogu se pojaviti ako Vaše dijete uzme previše lijeka REYATAZ.
REYATAZ should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index. 
REYATAZ se ne smije primjenjivati u kombinaciji s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski indeks.
In a non-clinical fertility and early embryonic development study in rats, atazanavir altered oestrus cycling with no effects on mating or fertility (see section 5.3). 
U nekliničkim ispitivanjima utjecaja na plodnost i rani embrionalni razvoj u štakora, atazanavir je promijenio ciklus estrusa bez učinaka na parenje ili plodnost (vidjeti dio 5.3).
The pharmacokinetic data from HIV-infected pregnant women receiving REYATAZ capsules with ritonavir are presented in Table 9. 
Farmakokinetički podaci prikupljeni u trudnica zaraženih HIV-om koje su uzimale REYATAZ kapsule s ritonavirom prikazani su u tablici 9.
Larger volumes or quantities of liquid infant formula, beverage or food may be used. 
Za doziranje se mogu primijeniti i veći volumeni ili količine tekuće dojenačke formule, pića ili hrane.
Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12hr ↑77% The mechanism is UGT1A1 inhibition. 
Raltegravir AUC ↑41% Raltegravir Cmax↑24% Raltegravir C12hr↑77% Mehanizam je inhibicija UGT1A1.
For treatment-experienced paediatric patients, the mean baseline CD4 cell count was 1441 cells/mm 
Za liječenje pedijatrijskih bolesnika koji su prethodno bili liječeni srednja početna vrijednost broja CD4 stanica bila je 1441 stanica /mm
Instructions for REYATAZ oral powder: 
Upute za primjenu REYATAZ oralanog praška:
Fifteen of 120 (13%) patients in the REYATAZ + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90. 
+ ritonavir i 17 od 123 (14%) bolesnika u skupini koja je primala lopinavir + ritonavir imalo je četiri ili više supstitucija za rezistenciju na inhibitore proteaze: L10, M46, I54, V82, I84 i L90.
Among patients who received REYATAZ 400 mg once daily or REYATAZ 300 mg with ritonavir 100 mg once daily, the only adverse reactions of any severity reported very commonly with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs were nausea (20%), diarrhoea (10%), and jaundice (13%). 
Među bolesnicima koji su primali REYATAZ 400 mg jedanput na dan ili REYATAZ 300 mg s ritonavirom 100 mg jedanput na dan, jedine vrlo često zabilježene nuspojave bilo koje težine s barem mogućom povezanošću s protokolima koji sadrže REYATAZ i jedan ili više NRTI-jeva bile su mučnina (20%), proljev (10%) i žutica (13%).
CD4 Mean Change from Baseline, cells/mm3 All patients 
CD4 prosječna promjena od početne vrijednosti, stanice/mm3 Svi bolesnici
The REYATAZ/ritonavir arm showed 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 (Table 5). 
U skupini koja je primala REYATAZ/ritonavir utvrđena je antivirusna djelotvornost slična (neinferiorna) onoj u skupini koja je primala lopinavir/ritonavir, što je procijenjeno na temelju udjela bolesnika s HIV RNK < 50 kopija/ml u 48. tjednu (tablica 5).
Polyester film/Aluminum/Polyethylene sealant film sachet. 
Troslojna vrećica od poliestera/aluminija/polietilena.
Atazanavir and fluconazole concentrations were not significantly modified when REYATAZ/ritonavir was co-administered with fluconazole. 
Koncentracije atazanavira i flukonazola nisu bile značajno promijenjene kad se REYATAZ s ritonavirom primjenjivao istovremeno s flukonazolom.
common: rash; uncommon: erythemia multiforme a,b 
manje često: multiformni eritem a,b
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
Paediatric patients (at least 3 months of age and weighing at least 5 kg): REYATAZ oral powder is available for paediatric patients at least 3 months of age and weighing at least 5 kg (see Summary of Product Characteristics for REYATAZ oral powder). 
Pedijatrijski bolesnici (u dobi od najmanje 3 mjeseca i tjelesne težine odnajmanje 5 kg): REYATAZ oralni prašak dostupan je za pedijatrijske bolesnike u dobi od najmanje 3 mjeseca i tjelesne težine od najmanje 5 kg (vidjeti Sažetak opisa svojstava lijeka za REYATAZ oralni prašak).
QT prolongation: Dose related asymptomatic prolongations in PR interval with REYATAZ have been observed in clinical studies. 
Produljenje QT intervala: U kliničkim je ispitivanjima opaženo asimptomatsko produljenje PR intervala povezano s dozom lijeka REYATAZ.
If REYATAZ is co-administered with irinotecan, patients should be closely monitored for adverse events related to irinotecan. 
Ako se REYATAZ primjenjuje istovremeno s irinotekanom, bolesnike treba pažljivo pratiti zbog nuspojava povezanih s irinotekanom.
A large prospective observational study has shown an association between an increased incidence of chronic kidney disease and cumulative exposure to atazanavir/ritonavir-containing regimen in HIV-infected patients with an initially normal eGFR. 
Veliko prospektivno opservacijsko ispitivanje pokazalo je povezanost između povećan incidencije kronične bubrežne bolesti i kumulativnog izlaganja režimu koji sadrži atazanavir/ritonavir u bolesnika zaraženih HIV-om, s početno norrmalnom eGFR.
The pharmacokinetic data from HIV-infected pregnant women receiving REYATAZ capsules with ritonavir are presented in Table 8. 
Farmakokinetički podaci prikupljeni u trudnica zaraženih HIV-om koje su uzimale REYATAZ kapsule s ritonavirom prikazani su u tablici 8.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of 1.5 g oral powder contains 50 mg of atazanavir (as sulphate). 
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica s 1,5g oralnog praška sadrži 50 mg atazanavira (u obliku atazanavirsulfata).
In a per protocol analysis which excluded non-completers (i.e. patients who discontinued before the week 48 HIV RNA assessment) and patients with major protocol deviations, the proportion of patients with HIV RNA < 50 copies/ml at week 48 was 86% (338/392) for REYATAZ/ritonavir and 89% (332/372) for lopinavir/ritonavir (difference estimate of ATV/RTV-LPV/RTV: -3% [95% CI, -7.6%, 
Prema analizi po realiziranom protokolu koja je isključila bolesnike koji nisu dovršili ispitivanje (npr. bolesnici koji su prekinuli terapiju prije procjene HIV RNK u 48. tjednu) i bolesnike s velikim odstupanjima od protokola, udio bolesnika s HIV RNK < 50 kopija/ml u 48. tjednu bio je 86% (338/392) za REYATAZ/ritonavir i 89% (332/372) za lopinavir/ritonavir (procjena razlike ATV/RTVLPV/RTV: -3% [95% CI, -7,6%, 1,5%].
Co-administration with REYATAZ with ritonavir warrants clinical monitoring for sedation and cognitive effects. 
Istovremena primjena s lijekom REYATAZ i ritonavirom zahtijeva kliničko praćenje zbog sedacije i kognitivnih učinaka.
When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir disoproxil fumarate, atazanavir concentrations are expected to be additionally decreased by about 20%. 
Kad se uspoređuje s atazanavirom 300 mg s ritonavirom 100 mg bez tenofovirdizoproksilfumarata, očekuje se da će koncentracije atazanavira biti dodatno smanjene za približno 20%.
Patients exposed only to antiretrovirals in utero or intrapartum were considered treatment-naive. 
Bolesnici koji su bili izloženi antiretrovirusnim lijekovima samo in utero i tijekom poroda smatrali su se bolesnicima koji nisu bili prethodno liječeni.
(See sections 4.2 and 4.4.) 
(Vidjeti dio 4.4.
Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is coadministered with REYATAZ, based on these data. 
Budući da se pokazalo da niska doza ritonavira (100 mg dvaput na dan) nema značajan učinak na koncentraciju metadona, na temelju tih se podataka ne očekuje interakcija kod istovremene primjene metadona i lijeka REYATAZ.
REYATAZ/ritonavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index. 
REYATAZ/ritonavir se ne smije primjenjivati u kombinaciji s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski indeks.
Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is coadministered with REYATAZ and ritonavir, based on these data. 
Budući da se pokazalo da niska doza ritonavira (100 mg dvaput na dan) nema značajan učinak na koncentraciju metadona, na temelju tih se podataka ne očekuje interakcija kod istovremene primjene metadona i lijeka REYATAZ i ritonavira.
Three of 20 infants (15%) born to women treated with REYATAZ/ritonavir 300/100 mg and four of 20 infants (20%) born to women treated with REYATAZ/ritonavir 400/100 mg experienced grade 3-4 bilirubin. 
Troje od 20 dojenčadi (15%) žena liječenih s REYATAZ/ritonavirom 300/100 mg i četvero od 20 dojenčadi (20%) žena liječenih s REYATAZ/ritonavirom 400/100 mg imalo je bilirubin 3.-4. stupnja.
It is recommended that the INR be monitored carefully during treatment with 
Preporučuje se pažljivo pratiti međunarodni normalizirani omjer (INR) tijekom liječenja lijekom