FrancophonIA/ELRC3.0 huggingface dataset:
English: Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with Stribild.
Croatian: Kobicistat reverzibilno inhibira MATE1, stoga se koncentracije metformina mogu povećati s istodobnom primjenom Stribilda.
English: A study of pharmacokinetics of cobicistat-boosted elvitegravir was performed in non-HIV-1 infected subjects with severe renal impairment (creatinine clearance below 30 mL/min).
Croatian: Ispitivanje farmakokinetike kobicistatom pojačanog elvitegravira provedeno je na ispitanicima koji nisu zaraženi virusom HIV-1, a koji imaju teško oštećenje bubrega (klirens kreatinina ispod 30 ml/min).
English: AUCtau, and Ctrough (mean ± SD) were 1.1 ± 0.40 µg/mL, 8.3 ± 3.8 µg•h/mL, and 0.05 ± 0.13 µg/mL for cobicistat, 1.9 ± 0.5 µg/mL, 13 ± 4.5 µg•h/mL, and 0.14 ± 0.25 µg/mL for emtricitabine, and 0.45 ± 0.16 µg/mL, 4.4 ± 2.2 µg•h/mL, and 0.1 ± 0.08 µg/mL for tenofovir.
Croatian: Odgovarajuće srednje vrijednosti Cmax, AUCtau i Ctrough (srednja vrijednost ± SD) u stanju dinamičke ravnoteže bile su 1,1 ± 0,40 µg/ml, 8,3 ± 3,8 µg•h/ml i 0,05 ± 0,13 µg/ml za kobicistat, 1,9 ± 0,5 µg/ml, 13 ± 4,5 µg•h/ml i 0,14 ± 0,25 µg/ml za emtricitabin i 0,45 ± 0,16 µg/ml, 4,4 ± 2,2 µg•h/ml i 0,1 ± 0,08 µg/ml za tenofovir.
English: Virologic success HIV-1 RNA < 50 copies/mL Treatment difference
Croatian: Virološki uspjeh HIV-1 RNK < 50 kopija/ml
English: The Cmax and AUC of tenofovir increased 20% and 25% respectively with a light meal, while the Cmax was unaffected and AUC increased 25% with a high fat meal.
Croatian: Vrijednosti Cmax i AUC za tenofovir povećale su se 20%, odnosno 25% s laganim obrokom, dok s visokomasnim obrokom vrijednost Cmax nije bila izmijenjena, a vrijednost AUC povećala se 25%.
English: angioedema1
Croatian: angioedem1
English: The cobicistat component of Stribild has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting renal glomerular function.
Croatian: Pokazalo se da komponenta kobicistata u Stribildu smanjuje procijenjeni klirens kreatinina zbog inhibicije tubularne sekrecije kreatinina bez utjecaja na glomerularnu funkciju bubrega.
English: 5 This adverse reaction was identified through post-marketing surveillance for emtricitabine or tenofovir disoproxil but not observed in randomised, controlled clinical studies in adults or paediatric HIV clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil expanded access program for tenofovir disoproxil.
Croatian: Ova nuspojava prepoznata je tijekom praćenja lijeka nakon stavljanja u promet za emtricitabin ili tenofovirdizoproksil, ali nije bila opažena u randomiziranim kontroliranim kliničkim ispitivanjima emtricitabina u odraslih ili u pedijatrijskih bolesnika inficiranih HIV-om ili u randomiziranim kontroliranim ispitivanjima tenofovirdizoproksila ili programu proširenog pristupa liječenju tenofovirdizoproksilom.
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil
Croatian: INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5)
English: Co-administration of Stribild and some medicinal products that are primarily metabolised by CYP3A may result in increased plasma concentrations of these products, which are associated with the potential for serious and/or life-threatening reactions such as peripheral vasospasm or ischaemia (e.g., dihydroergotamine, ergotamine, ergometrine), or myopathy, including rhabdomyolysis (e.g., simvastatin, lovastatin), or prolonged or increased sedation or respiratory depression (e.g., orally administered midazolam or triazolam).
Croatian: Istodobna primjena Stribilda i nekih lijekova koje prvenstveno metabolizira CYP3A može rezultirati povećanim koncentracijama tih lijekova u plazmi, koje su povezane s potencijalno ozbiljnim i/ili životno opasnim reakcijama, kao što su periferni vazospazam ili ishemija (npr. dihidroergotamin, ergotamin, ergometrin) ili miopatija, uključujući i rabdomiolizu (npr. simvastatin, lovastatin) ili dugotrajna ili povećana sedacija ili respiratorna depresija (npr. midazolam primijenjen peroralno, triazolam).
English: The substitutions that emerged were M184V/I (n = 17) and K65R (n = 5) in reverse transcriptase and E92Q (n = 9), N155H (n = 5), Q148R (n = 3), T66I (n = 2), and T97A (n = 1) in integrase.
Croatian: E92Q (n = 9), N155H (n = 5), Q148R (n = 3), T66I (n = 2) i T97A (n = 1) u integrazi.
English: Stribild has limited data in patients over the age of 65 years.
Croatian: Podaci o primjeni Stribilda u bolesnika starijih od 65 godina su ograničeni.
English: • any other medicines containing: tenofovir disoproxil tenofovir alafenamide lamivudine adefovir dipivoxil
Croatian: • bilo koji drugi lijek koji sadrži: tenofovirdizoproksil tenofoviralafenamid lamivudin adefovirdipivoksil.
English: Tenofovir exposures were in the range of those observed in tenofovir disoproxil-containing boosted-protease inhibitor regimens.
Croatian: Izloženosti tenofoviru bile su u rasponu opaženom u sklopu režima tenofovirdizoproksila koji je sadržavao pojačane inhibitore proteaze.
English: Animal studies do not indicate harmful effects of elvitegravir, cobicistat, emtricitabine or tenofovir disoproxil on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke elvitegravira, kobicistata, emtricitabina ili tenofovirdizoproksila na plodnost.
English: 1 This adverse reaction was not observed in the Phase 3 clinical studies for Stribild but identified from clinical studies or post-marketing experience for emtricitabine or tenofovir disoproxil when used with other antiretrovirals.
Croatian: 1 Ova nuspojava nije uočena u fazi 3 kliničkih ispitivanja Stribilda ali je prepoznata u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet za emtricitabin ili tenofovirdizoproksil kada su se koristili s drugim antiretrovirusnim lijekovima.
English: In the clinical studies of Stribild over 144 weeks, 13 (1.9%) subjects in the Stribild group (n = 701) and 8 (2.3%) subjects in the ATV/r+FTC/tenofovir disoproxil group (n = 355) discontinued study drug due to a renal adverse reaction.
Croatian: U kliničkim ispitivanjima Stribilda u trajanju od 144 tjedna, 13 ispitanika (1,9%) iz skupine koja je primala Stribild (n = 701) i 8 ispitanika (2,3%) iz skupine koja je primala ATV/r+ FTC/tenofovirdizoproksil (n = 355) prekinuli su primanje ispitivanog lijeka zbog nuspojava na bubrezima.
English: Co-administration with Stribild may increase dabigatran plasma concentrations with similar effects as seen with other strong P-gp inhibitors.
Croatian: Koncentracije dabigatrana u plazmi mogu se povećati pri istodobnoj primjeni Stribilda, s učinkom sličnim kao kod drugih jakih P-gp inhibitora.
English: Two of the four subjects had renal impairment (i.e. estimated creatinine clearance less than 70 mL/min) at baseline.
Croatian: Na početku ispitivanja dva od četiri ispitanika imala su oštećenje bubrega (tj. procijenjeni klirens kreatinina manji od 70 ml/min).
English: In study GS-US-104-0352, 89 paediatric patients with a median age of 7 years (range 2 to 15 years) were exposed to tenofovir disoproxil for a median of 331 weeks.
Croatian: U kliničkom ispitivanju GS-US-104-0352, 89 pedijatrijskih bolesnika s medijanom dobi od 7 godina (raspon od 2 do 15 godina) bili su izloženi tenofovirdizoproksilu s medijanom od 331 tjedna.
English: Creatinine clearance should be calculated and urine glucose and urine protein should be determined in all patients.
Croatian: Mora se izračunati klirens kreatinina i moraju se utvrditi glukoza i proteini u urinu u svih bolesnika.
English: In Study GS-US-236-0115 and Study GS-US-236-0121, patients had to be on either their first or second antiretroviral regimen with no history of virologic failure, have no current or past history of resistance to the antiretroviral components of Stribild and must have been suppressed on a PI+RTV or an NNRTI in combination with FTC/tenofovir disoproxil (HIV-1 RNA < 50 copies/mL) for at least six months prior to screening.
Croatian: U ispitivanjima GS-US-236-0115 i GS-US-236-0121 bolesnici su morali primati svoj prvi ili drugi antiretrovirusni režim bez prethodnog virološkog neuspjeha, nisu smjeli imati zabilježenu prošlu ili sadašnju rezistenciju na antiretrovirusne tvari u Stribildu i i virus je morao biti suprimiran PI+RTV-om ili NNRTI-jem u kombinaciji s FTC/tenofovirdizoproksil (HIV-1 RNK < 50 kopija/ml) najmanje šest mjeseci prije probira.
English: The mean decrease in HIV-1 RNA was −3.16 log10 copies/mL, and the mean increase in CD4+ cell count was 229 cells/mm3.
Croatian: Srednja vrijednost smanjenja HIV-1 RNK iznosila je −3,16 log10 kopija/ml, a srednja vrijednost povećanja broja stanica CD4+ iznosila je 229 stanica/mm³.
English: Patients who have previously discontinued treatment with tenofovir disoproxil due to renal toxicity, with or without reversal of the effects post-discontinuation.
Croatian: Bolesnici koji su prethodno prekinuli liječenje s tenofovirdizoproksilom zbog bubrežne toksičnosti, s ili bez povratka učinaka nakon prekida primjene lijeka.
English: Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Stribild.
Croatian: Ne preporučuje se istodobna primjena apiksabana, rivaroksabana ili edoksabana s lijekom Stribild.
English: Twenty percent had baseline plasma HIV-1 RNA >100,000 copies/mL.
Croatian: Dvadeset posto ispitanika imalo je početnu vrijednost HIV-1 RNK > 100 000 kopija/ml.
English: If bone abnormalities are detected or suspected in paediatric patients, consultation with an endocrinologist and/or nephrologist should be obtained.
Croatian: Ako se sumnja ili primijete abnormalnosti na kostima u pedijatrijskih bolesnika, potrebna je konzultacija s endokrinologom i/ili nefrologom.
English: In studies GS-US-236-0102 and GS-US-236-0103, decreases in estimated creatinine clearance occurred early in treatment with Stribild, after which they stabilised.
Croatian: U ispitivanjima GS-US-236-0102 i GS-US-236-0103, smanjenje procijenjenog klirensa kreatinina zabilježeno je na početku liječenja Stribildom, nakon čega se klirens stabilizirao.
English: In Study GS-US-236-0103, 27 patients treated with Stribild had HIV-1 with the NNRTI-associated K103N substitution in reverse transcriptase at baseline and had virologic success (82% at Week 144) similar to the overall population (78%), and no emergent resistance to elvitegravir, emtricitabine, or tenofovir in their HIV-1.
Croatian: U ispitivanju GS-US-236-0103, 27 bolesnika liječenih Stribildom imalo je HIV-1 sa supstitucijom K103N povezanom s NNRTI-om u reverznoj transkriptazi na početku ispitivanja, imalo je virološki uspjeh (82% u 144. tjednu) sličan ukupnoj populaciji (78%) i nije razvilo novonastalu rezistenciju na elvitegravir, emtricitabin i tenofovir u HIV-1.
English: Stribild should be administered with caution to elderly patients (see section 4.4).
Croatian: Stribild se mora primjenjivati s oprezom u starijih bolesnika (vidjeti dio 4.4).
English: Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (also called aldesleukin).
Croatian: Neki primjeri uključuju, ali nisu ograničeni na aminoglikozide, amfotericin B, foskarnet, ganciklovir, pentamidin, vankomicin, cidofovir ili interleukin-2 (također se naziva aldesleukin).
English: Stribild should be discontinued if creatinine clearance declines below 50 mL/min during treatment with Stribild as dose interval adjustment is required for emtricitabine and tenofovir disoproxil and this cannot be achieved with the fixed-dose combination tablet (see sections 4.4 and 5.2).
Croatian: Primjena Stribilda se mora prekinuti ako klirens kreatinina padne ispod 50 ml/min tijekom liječenja Stribildom jer je potrebna prilagodba intervala doziranja za emtricitabin i tenofovirdizoproksil, a to se ne može postići s kombiniranom tabletom fiksne doze (vidjeti dijelove 4.4 i 5.2).
English: Stribild should not be initiated in patients with creatinine clearance < 70 mL/min.
Croatian: Stribild se ne smije započeti u bolesnika s klirensom kreatinina < 70 ml/min.
English: Five subjects (5.6%) had laboratory findings clinically consistent with proximal renal tubulopathy, 4 of whom discontinued tenofovir disoproxil therapy.
Croatian: . Pet ispitanika (5,6 %) imalo je laboratorijske nalaze koji klinički odgovaraju proksimalnoj bubrežnoj tubulopatiji, od kojih je njih 4 prekinulo liječenje tenofovirdizoproksilom.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Croatian: Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bocu s 30 filmom obloženih tableta i 90 (3 boce od 30) filmom obloženih tableta.
English: If serum phosphate is < 0.48 mmol/L (1.5 mg/dL) or creatinine clearance is decreased to < 70 mL/min, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8).
Croatian: Ako je fosfat u serumu < 0,48 mmol/l (1,5 mg/dl) ili ako se klirens kreatinina smanji na < 70 ml/min, unutar jednoga tjedna treba ponovno procijeniti funkciju bubrega, uključujući mjerenja koncentracije glukoze u krvi, kalija u krvi i glukoze u urinu (vidjeti dio 4.8).
English: The use of Stribild with oral contraceptives containing other progestogens should be avoided (see section 4.5).
Croatian: Primjenu Stribilda i oralnih kontraceptiva koji sadrže druge progestagene treba izbjegavati (vidjeti dio 4.5).
English: Stribild has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Stribild nije ispitivan u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C).
English: In the Phase 3 studies GS-US-236-0102 and GS-US-236-0103, bone fractures occurred in 27 subjects (3.9%) in the Stribild group, 8 subjects (2.3%) in the EFV/FTC/tenofovir disoproxil group, and 19 subjects (5.4%) in the ATV/r+FTC/tenofovir disoproxil group.
Croatian: U fazi 3 ispitivanja GS-US-236-0102 i GS-US-236-0103, prijelomi kostiju dogodili su se u 27 ispitanika (3,9%) u skupini koja je primila Stribild, u 8 ispitanika (2,3%) u skupini koja je primala EFV/FTC/tenofovirdizoproksil i u 19 ispitanika (5,4%) u skupini ATV/r+FTC/tenofovirdizoproksil.
English: Croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate.
Croatian: Umrežena karmelozanatrij, hidroksipropilceluloza, laktoza hidrat, magnezijev stearat, mikrokristalična celuloza, silicijev dioksid, natrijev laurilsulfat.
English: Co-administration of Stribild with medicinal products that are primarily metabolised by CYP3A or CYP2D6, or are substrates of P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of those products, which could increase or prolong their therapeutic effect and adverse reactions (see Concomitant use contraindicated and section 4.3).
Croatian: Istodobna primjena Stribilda i lijekova koje prvenstveno metabolizira CYP3A ili CYP2D6, ili koji su supstrati P-gp, BCRP, OATP1B1 ili OATP1B3 može za posljedicu imati povećane koncentracije tih lijekova u plazmi, što može uzrokovati povećanje ili produljenje njihova terapijskog učinka i nuspojava (vidjeti „Kontraindicirana istodobna primjena” i dio 4.3).
English: In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected clinically by tenofovir disoproxil and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Croatian: Dodatno, K70E supstitucija u HIV-1 reverznoj transkriptazi klinički je izdvojena tenofovirdizoproksilom, a rezultira malim smanjenjem osjetljivosti na abakavir, emtricitabin, tenofovir i lamivudin.
English: Among 28 patients receiving 96 weeks of treatment with tenofovir disoproxil, BMD Z-scores declined by -0.341 for lumbar spine and -0.458 for total body.
Croatian: U 28 bolesnika koji su tijekom 96 tjedana primali tenofovirdizoproksil, Z-vrijednosti BMD-a smanjile su se za -0,341 u lumbalnoj kralježnici i -0,458 u cijelom tijelu.
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any adult with renal impairment treated with Stribild (see sections 4.2, 4.4 and 5.2).
Croatian: Tenofovirdizoproksil može prouzročiti bubrežnu toksičnost, pa se preporučuje pomno nadziranje funkcije bubrega u svakog odraslog bolesnika s oštećenom funkcijom bubrega koji se liječi Stribildom (vidjeti dijelove 4.2, 4.4 i 5.2).
English: In Study GS-US-236-0115, virologic success rates were: Stribild 93.8% (272 of 290 patients); SBR 87.1% (121 of 139 patients).
Croatian: U ispitivanju GS-US-236-0115 stope virološkog uspjeha iznosile su: za Stribild 93,8% (272 od 290 bolesnika), a za SBR 87,1% (121 od 139 bolesnika).
English: Stribild should not be administered concomitantly with other medicinal products containing tenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatment of hepatitis B virus infection.
Croatian: Stribild se ne smije primjenjivati istodobno s drugim lijekovima koji sadrže tenofovirdizoproksil, lamivudin ili adefovirdipivoksil koji se koriste za liječenje infekcije virusom hepatitisa B.
English: If the patient misses a dose of Stribild within 18 hours of the time it is usually taken, the patient should take Stribild with food as soon as possible and resume the normal dosing schedule.
Croatian: Ako bolesnik propusti uzeti dozu Stribilda, a prošlo je manje od 18 sati od uobičajenog vremena uzimanja doze, bolesnik mora što prije uzeti Stribild s hranom i potom ga nastaviti uzimati prema uobičajenom rasporedu.
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Croatian: U bolesnika s uznapredovalom bolešću jetre ili cirozom jetre, ne preporučuje se prekidati liječenje jer egzacerbacija hepatitisa nakon liječenja može dovesti do dekompenzacije jetre.
English: betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Croatian: • kortikosteroide koji uključuju: betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon.
English: Table 4: Virologic outcome of randomised treatment of studies GS-US-236-0102 and GS-US-236-0103 at Week 48 (snapshot analysis)a and Week 144b
Croatian: Tablica 4: Virološki ishod randomiziranog liječenja u ispitivanjima GS-US-236-0102 i GS-US-236-0103 u 48. tjednu (analiza snimaka)a i u 144. tjednub
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLe
Croatian: Prekid primanja ispitivanog lijeka iz drugih razloga i posljednje dostupne vrijednosti HIV-1 RNK < 50 kopija/
English: In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported.
Croatian: U bolesnika koji su primali tenofovirdizoproksil zabilježeni su rijetki slučajevi oštećenja bubrega, zatajenja bubrega i manje česti slučajevi proksimalne bubrežne tubulopatije (uključujući Fanconijev sindrom), što je ponekad dovelo do koštanih poremećaja (koji rijetko pridonose nastanku prijeloma).
English: In Study GS-US-236-0121, virologic success rates were: Stribild 93.4% (271 of 290 patients) and SBR 88.1% (126 of 143 patients).
Croatian: U ispitivanju GS-US-236-0121 stope virološkog uspjeha iznosile su: za Stribild 93,4% (271 od 290 bolesnika), a za SBR 88,1% (126 od 143 bolesnika).
English: The Summary of Product Characteristics II.
Croatian: Sažetak opisa svojstava lijeka II.
English: Stribild should not be administered concomitantly with other medicinal products containing tenofovir disoproxil , lamivudine or adefovir dipivoxil used for the treatment of hepatitis B virus infection, or with other medicinal products containing tenofovir alafenamide.
Croatian: Stribild se ne smije primjenjivati istodobno s drugim lijekovima koji sadržavaju tenofovirdizoproksil, lamivudin ili adefovirdipivoksil koji se primjenjuju za liječenje infekcije virusom hepatitisa B ili s drugim lijekovima koji sadrže tenofoviralafenamid.
English: The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) following multiple doses of Stribild in HIV-1 infected subjects, respectively, were 1.7 ± 0.39 µg/mL, 23 ± 7.5 µg•h/mL, and 0.45 ± 0.26 µg/mL for elvitegravir, which provides inhibitory quotient of ~ 10 (ratio of Ctrough: protein binding-adjusted IC95 for wild-type HIV-1 virus).
Croatian: Srednje vrijednosti Cmax, AUCtau i Ctrough (srednja vrijednost ± SD) u stanju dinamičke ravnoteže nakon više doza Stribilda u bolesnika zaraženih virusom HIV-1 bile su 1,7 ± 0,39 µg/ml, odnosno 23 ± 7,5 µg•h/ml, i 0,45 ± 0,26 µg/ml za elvitegravir, što omogućuje inhibitorski kvocijent od ~10 (omjer Ctrough: IC95 s prilagođenim proteinskim vezivanjem za divlji tip virusa HIV-1).
English: In the Phase 3 Study GS-US-236-0103, bone mineral density (BMD) was assessed in a non-random subset of 120 subjects (Stribild group n = 54; ritonavir-boosted atazanavir (ATV/r) plus emtricitabine (FTC)/tenofovir disoproxil group n = 66).
Croatian: U fazi 3 ispitivanja GS-US-236-0103, mineralna gustoća kostiju (BMD) procijenjena je u podskupini od 120 ispitanika (skupina koja je primala Stribild, n = 54; skupina koja je primala ritonavirom pojačan atazanavir (ATV/r) plus emtricitabin (FTC)/tenofovirdizoproksil), n = 66) koji nisu bili nasumično odabrani.
English: How to store Stribild
Croatian: Kako čuvati Stribild
English: Emtricitabine/Tenofovir disoproxil (200 mg/245 mg once daily)7
Croatian: + emtricitabin/tenofovirdizoproksil (200 mg/245 mg jedanput na dan)7
English: Patients who have previously discontinued treatment with tenofovir disoproxil due to renal toxicity, with or without reversal of the effects post-discontinuation, should not be treated with Stribild (see section 4.3).
Croatian: Bolesnici koji su prethodno prekinuli liječenje s tenofovirdizoproksilom zbog bubrežne toksičnosti, s ili bez povratka učinaka nakon prekida primjene lijeka, ne smiju se liječiti Stribildom (vidjeti dio 4.3).
English: The mean increase from baseline in CD4+ cell count at Week 48 was 23 cells/mm3.
Croatian: Srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ u 48. tjednu bila je 23 stanice/mm3.
English: renal failure4, proximal renal tubulopathy including Fanconi syndrome acquired4, proteinuria
Croatian: zatajenje bubrega4, proksimalna bubrežna tubulopatija uključujući stečeni Fanconijev sindrom4, proteinurija
English: • medicines used to treat pulmonary arterial hypertension:
Croatian: • lijekove koji se primjenjuju za liječenje plućne arterijske hipertenzije: bosentan
English: Plasma concentrations of drospirenone are expected to be increased following co-administration with Stribild and clinical monitoring is recommended due to the potential for hyperkalaemia (see section 4.5).
Croatian: Budući da se očekuje da će se nakon istodobne primjene s lijekom Stribild koncentracije drospirenona u plazmi povećati, preporučuje se kliničko praćenje zbog moguće pojave hiperkalijemije (vidjeti dio 4.5).
English: Cobicistat inhibits the tubular secretion of creatinine and may cause modest increases in serum creatinine and modest declines in creatinine clearance (see section 4.8).
Croatian: Kobicistat inhibira tubularnu sekreciju kreatinina i može uzrokovati umjereni porast serumskog kreatinina i umjerena sniženja klirensa kreatinina (vidjeti dio 4.8).
English: At baseline, mean plasma HIV-1 RNA was 4.60 log10 copies/mL, mean CD4+ cell count 399 cells/mm3 (range, 133-734), and mean CD4+% 20.9% (range, 4.5%-41.1%).
Croatian: Početna srednja vrijednost HIV-1 RNK u plazmi bila je 4,60 log10 kopija/ml, početna srednja vrijednost broja stanica CD4+ bila je 399 stanica/mm3 (raspon, 133-734) i postotak ispitanika s brojem stanica CD4+% bio je 20,9% (raspon, 4,5%-41,1%).