FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Stribild in HIV-1 infected treatment-naïve adult patients is based on the analyses of 144-week data from 2 randomised, double-blinded, active-controlled, Phase 3 studies, GS-US-236-0102 and GS-US-236-0103 (n = 1,408).
Croatian: Djelotvornost Stribilda u odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni temelji se na analizama podataka iz 2 randomizirana, dvostruko slijepa, kontrolirana aktivnim lijekom, ispitivanja faze 3, GS-US-236-0102 i GS-US-236-0103, u trajanju od 144 tjedna (n = 1408).
English: (may affect at least 1 in every 10 patients treated)
Croatian: (mogu se javiti u najmanje 1 na svakih 10 liječenih bolesnika)
English: • decreased levels of potassium in the blood
Croatian: • smanjene razine kalija u krvi
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and a CYP3A substrate.
Croatian: Kobicistat je jak inhibitor mehanizma enzima CYP3A i supstrat CYP3A.
English: In study GS-US-104-0352, 97 treatment experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
Croatian: U ispitivanju GS-US-104-0352, 97 prethodno liječenih bolesnika u dobi od 2 do 12 godina sa stabilnom virološkom supresijom režimima koji su sadržavali stavudin ili zidovudin, bilo je randomizirano u skupinu u kojoj je stavudin ili zidovudin zamijenjen tenofovirdizoproksilom (n = 48) ili u skupinu koja je nastavila primati prvobitni režim (n = 49) 48 tjedana.
English: hypokalaemia1,3
Croatian: hipokalemija1,3
English: That Stribild is not recommended for use in adolescent patients with renal impairment.
Croatian: Da se ne preporučuje uporaba Stribilda u adolescentnih bolesnika s oštećenjem funkcije bubrega.
English: It is recommended that digoxin levels be monitored when digoxin is combined with Stribild.
Croatian: Prilikom kombinacije digoksina i Stribilda preporučuje se nadzor razina digoksina.
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Croatian: Pokazalo se da istodobna primjena tenofovirdizoproksila s ledipasvirom/sofosbuvirom, sofosbuvirom/velpatasvirom ili sofosbuvirom/velpatasvirom/voksilaprevirom povećava koncentraciju tenofovira u plazmi, posebno prilikom istodobne primjene s režimom liječenja HIV-a koji sadrži tenofovirdizoproksil i farmakokinetički pojačivač (ritonavir ili kobicistat).
English: • tenofovir disoproxil, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI)
Croatian: • tenofovirdizoproksil, antiretrovirusni lijek poznat kao nukleotidni inhibitor reverzne transkriptaze (NtRTI).
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil (see section 4.8).
Croatian: Pri uporabi tenofovirdizoproksila zabilježeno je zatajenje bubrega, oštećenje bubrega, povišena razina kreatinina, hipofosfatemija i proksimalna tubulopatija (uključujući Fanconijev sindrom) (vidjeti dio 4.8).
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Stribild.
Croatian: U bolesnika koji uzimaju Stribild preporučuju se poman liječnički nadzor i prilagodba doze metformina.
English: If Stribild is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Croatian: Ako se prekine liječenje Stribildom u bolesnika koji su istodobno inficirani virusom HIV-a i virusom hepatitisa B (HBV), te bolesnike se mora pomno nadzirati zbog moguće pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
English: No emergent resistance to Stribild was identified in clinical studies of virologically-suppressed patients who switched from a regimen containing a ritonavir-boosted protease inhibitor (PI+RTV) (Study GS-US-236-0115), an NNRTI (Study GS-US-236-0121) or raltegravir (RAL) (Study GS-US-236-0123).
Croatian: U kliničkim ispitivanjima s bolesnicima kod kojih je virus suprimiran, a koji su prešli s režima koji je sadržavao ritonavirom pojačani inhibitor proteaze (PI+RTV) (ispitivanje GS-US-236-0115), NNRTI (ispitivanje GS-US-236-0121) ili raltegravir (RAL) (ispitivanje GS-US-236-0123) nije zabilježena novonastala rezistencija na Stribild.
English: Monitoring of renal function is recommended for patients receiving Stribild (see section 4.4).
Croatian: Preporučuje se praćenje funkcije bubrega u bolesnika koji primaju Stribild (vidjeti dio 4.4).
English: Use of Stribild is not recommended in paediatric patients under the age of 18 years with renal impairment (see section 4.4).
Croatian: Ne preporučuje se primjena Stribilda u pedijatrijskih bolesnika s oštećenjem bubrega mlađih od 18 godina (vidjeti dio 4.4).
English: • antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, fluconazole and posaconazole
Croatian: • lijekove protiv gljivica, primjenjuju se za liječenje gljivičnih infekcija, kao što su: ketokonazol, itrakonazol, vorikonazol, flukonazol i posakonazol
English: Clinically relevant changes in tenofovir pharmacokinetics in patients with hepatic impairment were not observed.
Croatian: Nisu zapažene klinički važne promjene u farmakokinetici tenofovira u bolesnika s oštećenjem funkcije jetre.
English: Concomitant use with nephrotoxic medicinal products Use of Stribild should be avoided with concurrent or recent use of a nephrotoxic medicinal product, e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin 2 (also called aldesleukin) (see section 4.5).
Croatian: Mora se izbjegavati uporaba Stribilda istodobno s primjenom ili nakon nedavne primjene nefrotoksičnog lijeka, npr. aminoglikozida, amfotericina B, foskarneta, ganciklovira, pentamidina, vankomicina, cidofovira ili interleukina 2 (također se naziva aldesleukin) (vidjeti dio 4.5).
English: It is not known whether elvitegravir or cobicistat are excreted in human milk.
Croatian: Nije poznato izlučuju li se elvitegravir ili kobicistat u majčino mlijeko u ljudi.
English: The potential risks and benefits associated with co-administration of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir with Stribild should be considered, particularly in patients at increased risk of renal dysfunction.
Croatian: Potrebno je razmotriti moguće rizike i koristi povezane s istodobnom primjenom ledipasvira/sofosbuvira, sofosbuvira/velpatasvira ili sofosbuvira/velpatasvira/voksilaprevira s lijekom Stribild, osobito u bolesnika s povećanim rizikom od poremećaja funkcije bubrega.
English: • back pain caused by kidney problems, including kidney failure.
Croatian: • bolovi u leđima prouzrokovani tegobama s bubrezima, uključujući zatajenje bubrega.
English: Black/African American Asian
Croatian: Srednja dob, godine (raspon) Spol muški ženski Rasna pripadnost bijelci crnci/afroamerika nci azijati drugi
English: • damage to kidney tubule cells
Croatian: • oštećenje stanica bubrežnih kanalića
English: Table 3: Demographic and baseline characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in studies GS-US-236-0102 and GS-US-236-0103
Croatian: Tablica 3: Demografske značajke i početne značajke u odraslih bolesnika zaraženih virusom HIV-1 koji prije nisu bili liječeni antiretrovirusnim lijekovima, u ispitivanjima GS-US-236-0102
English: At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~ 1.0 and the mean semen to plasma drug concentration ratio was ~ 4.0.
Croatian: Pri vršnoj koncentraciji u plazmi omjer srednje vrijednosti lijeka u plazmi i koncentracije lijeka u krvi iznosio je ~1,0, a omjer srednje vrijednosti koncentracije lijeka u spermi i koncentracije lijeka u plazmi iznosio je ~4,0.
English: In a clinical study of HIV-1-infected, treatment-naïve patients aged 12 to < 18 years (N=50), small decreases in mean BMD Z-scores were observed following treatment with Stribild (see section 4.8).
Croatian: U kliničkom ispitivanju s bolesnicima u dobi od 12 do 18 godina (N = 50) zaraženih virusom HIV-1 koji prethodno nisu bili liječeni, primijećeno je malo smanjenje srednje Z-vrijednosti BMD-a nakon liječenja Stribildom (vidjeti dio 4.8).
English: Co-administration of Stribild and lovastatin and simvastatin is contraindicated (see section 4.3).
Croatian: Istodobna primjena Stribilda i lovastatina i simvastatina je kontraindicirana (vidjeti dio 4.3).
English: 8 Study conducted with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fixed dose combination tablet.
Croatian: 8 Ispitivanje provedeno s kombiniranom tabletom fiksne doze elvitegravira/kobicistata/emtricitabina/tenofoviralafenamida.
English: ATV/r + FTC/ tenofovir disoproxil n = 355
Croatian: ATV/r + FTC/tenofovirdizoproksil n = 355
English: Co-administration with Stribild may result in increased plasma concentrations of these drugs, which is associated with the potential for serious and/or life-threatening reactions.
Croatian: Istodobnom primjena Stribilda može za posljedicu imati povećane koncentracije tih lijekova u plazmi, što je povezano s potencijalno ozbiljnim i/ili životno opasnim reakcijama.
English: The mean rate of lumbar spine bone gain at week 48 was similar between the tenofovir disoproxil treatment group and the stavudine or zidovudine treatment group.
Croatian: Srednja vrijednost brzine rasta koštane mase lumbalne kralježnice u 48. tjednu u skupini liječenoj tenofovirdizoproksilom bila je slična onoj u skupini liječenoj stavudinom ili zidovudinom.
English: cisapride (used to relieve certain stomach problems) St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it lovastatin, simvastatin (used to lower blood cholesterol) pimozide, lurasidone (used to treat abnormal thoughts or feelings) sildenafil (used to treat pulmonary arterial hypertension - a lung disease that makes breathing difficult) orally administered midazolam, triazolam (used to help you sleep and/or relieve anxiety)
Croatian: karbamazepin, fenobarbital, fenitoin (primjenjuju se za sprječavanje napadaja) rifampicin (primjenjuje se za sprječavanje i liječenje tuberkuloze i drugih infekcija) dihidroergotamin, ergotamin, ergometrin (primjenjuju se za liječenje migrene) cisaprid (primjenjuje se za ublažavanje određenih želučanih tegoba) gospina trava (Hypericum perforatum, biljni lijek koji se primjenjuje za depresiju i tjeskobu) ili lijekovi koji ju sadrže lovastatin, simvastatin (primjenjuju se za snižavanje kolesterola u krvi) pimozid, lurasidon (primjenjuje se za liječenje abnormalnih misli i osjećaja) sildenafil (primjenjuje se za liječenje plućne arterijske hipertenzije - bolest pluća koja otežava disanje) midazolam peroralno primijenjen, triazolam (pomaže Vam da zaspete i/ili za ublažavanje tjeskobe)
English: ANTIDEPRESSANTS Escitalopram Trazodone
Croatian: Escitalopram Trazodon
English: Elvitegravir/Cobicistat (150 mg/150 mg once daily)8
Croatian: + elvitegravir/kobicistat (150 mg/150 mg jedanput na dan)8
English: Co-administration of Stribild with medicinal products that inhibit CYP3A may decrease the clearance of cobicistat, resulting in increased cobicistat plasma concentrations.
Croatian: Istodobna primjena Stribilda i lijekova koji inhibiraju CYP3A može smanjiti klirens kobicistata, rezultirajući povećanim koncentracijama kobicistata u plazmi.
English: hypophosphataemia1,3
Croatian: hipofosfatemija1,3
English: No dose adjustment of clarithromycin is required for patients with normal renal function or mild renal impairment (ClCr 60-90 mL/min).
Croatian: U bolesnika s normalnom funkcijom bubrega ili blagim oštećenjem funkcije bubrega (ClCr 60-90 ml/min) nije potrebna prilagodba doze klaritromicina.
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Stribild.
Croatian: U slučaju istodobne primjene Stribilda preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
English: Virologically-suppressed HIV-1 infected patients
Croatian: Bolesnici zaraženi virusom HIV-1 kod kojih je virus suprimiran
English: Elvitegravir is metabolised by CYP3A and, to a minor extent, by UGT1A1.
Croatian: Elvitegravir se metabolizira putem CYP3A i u manjoj mjeri UGT1A1.
English: Ledipasvir/Sofosbuvir (90 mg/400 mg once daily) + Elvitegravir/Cobicistat (150 mg/150 mg once daily)
Croatian: Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan) + elvitegravir/kobicistat (150 mg/150 mg jedanput na dan)
English: The pharmacokinetics of elvitegravir, cobicistat and tenofovir have been studied in patients with moderate hepatic impairment.
Croatian: Farmakokinetika elvitegravira, kobicistata i tenofovira ispitana je u bolesnika s umjerenim oštećenjem funkcije jetre.
English: Mean baseline plasma HIV-1 RNA (range) log10 copies/mL Percentage of subjects with viral load > 100,000 copies/mL Mean baseline CD4+ cell count (range), x 106 cells/L
Croatian: Postotak ispitanika s virusnim opterećenjem > 100 000 kopija/ml Srednja vrijednost početnog broja stanica CD4+ (raspon), x 106 stanica/l Postotak ispitanika s brojem stanica CD4+ ≤ 200 stanica/mm3
English: In Study GS-US-236-0103 HIV-1 infected antiretroviral treatment-naïve adult patients received once daily treatment of Stribild or ritonavir-boosted atazanavir (ATV/r) plus fixed-dose combination of emtricitabine (FTC)/tenofovir disoproxil.
Croatian: U ispitivanju GS-US-236-0103 odrasli bolesnici zaraženi virusom HIV-1 koji prije nisu bili liječeni antiretrovirusnim lijekovima primali su Stribild jedanput dnevno ili ritonavirom pojačani atazanavir (ATV/r) plus kombinaciju emtricitabina (FTC)/tenofovirdizoproksila (FTC/TDF) u fiksnoj dozi jedanput dnevno.
English: Ketoconazole (200 mg twice daily)/Elvitegravir (150 mg once daily)2
Croatian: Ketokonazol (200 mg dvaput na dan) / elvitegravir (150 mg jedanput na dan)2
English: anaemia1,2
Croatian: anemija1,2
English: ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
Croatian: ANTAGONISTI ENDOTELINSKIH
English: Co-administration of carbamazepine, a potent CYP3A inducer, may significantly decrease cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Croatian: Istodobna primjena karbamazepina, snažnog induktora CYP3A, može značajno smanjiti koncentracije kobicistata i elvitegravira u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
English: Concentrations of ketoconazole and/or cobicistat may increase with co-administration of Stribild.
Croatian: Koncentracije ketokonazola i/ili kobicistata mogu se povećati s istodobnom primjenom Stribilda.
English: No dose adjustment of elvitegravir or cobicistat is necessary for patients with renal impairment.
Croatian: Nije potrebna prilagodba doze elvitegravira i kobicistata za bolesnike s oštećenjem bubrega.
English: Assessment of adverse reactions related to emtricitabine is based on experience in three paediatric studies (n = 169) where treatment-naïve (n = 123) and treatment-experienced (n = 46) paediatric HIV infected patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
Croatian: Procjena nuspojava povezanih s emtricitabinom temelji se na saznanjima iz triju pedijatrijskih ispitivanja (n = 169) provedenih u pedijatrijskih bolesnika u dobi od 4 mjeseca do 18 godina zaraženih virusom HIV-1, od kojih neki nisu bili prethodno liječeni (n = 123), a neki su bili prethodno liječeni (n = 46) kombinacijom emtricitabina i drugih antiretrovirusnih lijekova.
English: If Stribild is co-administered with an NSAID, renal function should be monitored adequately.
Croatian: Ako se Stribild primjenjuje istodobno s NSAIL-om, potrebno je provjeravati funkciju bubrega na odgovarajući način.
English: As in adults, adolescents who experience a confirmed increase in serum creatinine of greater than 26.5 µmol/L (0.3 mg/dL) from baseline should be closely monitored for renal safety (see above).
Croatian: Kao i u odraslih, adolescente u kojih je potvrđen porast serumskog kreatinina veći od 26,5 µmol/l (0,3 mg/dl) u odnosu na početne vrijednosti mora se pomno nadzirati zbog sigurnosti bubrega (vidjeti u prethodnom tekstu).
English: Caution should be exercised when co-administering Stribild and a hormonal contraceptive.
Croatian: Istodobna primjena Stribilda i hormonske kontracepcije mora se provoditi s oprezom.
English: (may affect 1 to 10 in every 100 patients treated)
Croatian: (mogu se javiti u 1 do 10 na svakih 100 liječenih bolesnika)
English: ANTIARRHYTHMICS Digoxin (0.5 mg single dose)/Cobicistat (150 mg multiple doses)
Croatian: Digoksin (jedna doza od 0,5 mg) / kobicistat (više doza od 150 mg)
English: • inflammation of the kidney (nephritis)
Croatian: • upala bubrega (nefritis)
English: alfuzosin (used to treat an enlarged prostate gland) amiodarone, quinidine (used to correct irregular heartbeats)
Croatian: • ako uzimate jedan od sljedećih lijekova: alfuzozin (primjenjuje se za liječenje povećane prostate) amiodaron, kinidin (primjenjuju se za ispravljanje nepravilnih otkucaja srca) dabigatran (primjenjuje se za sprječavanje i liječenje krvnih ugrušaka)
English: The same recommendations apply as in adults (see Co-administration of other medicinal products below).
Croatian: Istodobna primjena drugih lijekova i rizik od bubrežne toksičnosti Vrijede iste preporuke kao i za odrasle bolesnike (vidjeti pod Istodobna primjena drugih lijekova u nastavku).
English: Atorvastatin (10 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)
Croatian: Atorvastatin (jedna doza od 10 mg)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)/emtricitabin (200 mg jedanput na dan)/tenofoviralafenamid (10 mg jedanput na dan)
English: Co-administration of rifabutin, potent CYP3A inducer, may significantly decrease cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Croatian: Istodobna primjena rifabutina, snažnog induktora CYP3A, može značajno smanjiti koncentracije kobicistata i elvitegravira u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
English: No dose adjustment of elvitegravir or cobicistat is necessary for patients with mild to moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze elvitegravira i kobicistata za bolesnike s blagim do umjerenim oštećenjem funkcije jetre.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil.
Croatian: Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za kobicistatom pojačani elvitegravir, emtricitabin i tenofovirdizoproksil.
English: The efficacy and safety of Stribild in HIV-1-infected, treatment-naïve paediatric patients aged 12 to less than 18 years is based on the analyses of 48-week data from the single-group, open-label study GS-US-236-0112 (N=50).
Croatian: Djelotvornost i sigurnost Stribilda u pedijatrijskih bolesnika u dobi od 12 do 18 godina zaraženih virusom HIV-1 koji prethodno nisu bili liječeni, temelji se na analizama podataka iz otvorenog ispitivanja na jednoj skupini bolesnika GS-US-236-0112 (N = 50) u trajanju od 48 tjedana.
English: Buprenorphine: AUC: ↑ 35% Cmin: ↑ 66% Cmax: ↑ 12%
Croatian: Buprenorfin: AUC: ↑ 35% Cmin: ↑ 66% Cmax: ↑ 12%
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Stribild treatment.
Croatian: Ako se sumnja ili primijete abnormalnosti u funkciji bubrega, preporučuje se konzultacija s nefrologom kako bi se razmotrio prekid liječenja Stribildom.
English: pain1, fatigue
Croatian: bol1, umor
English: Co-administration of Stribild and orally administered midazolam and triazolam is contraindicated (see section 4.3).
Croatian: Istodobna primjena Stribilda i midazolama koji je primijenjen peroralno i triazolama je kontraindicirana (vidjeti dio 4.3).
English: • medicines used to treat gout:
Croatian: • lijekove koji se primjenjuju za liječenje gihta: kolhicin
English: The pharmacokinetics of emtricitabine have not been studied in patients with hepatic impairment.
Croatian: Farmakokinetika emtricitabina nije ispitivana u bolesnika s oštećenjem funkcije jetre.
English: Norgestimate: AUC: ↑ 126% Cmin: ↑ 167% Cmax: ↑ 108%
Croatian: AUC: ↑ 126% Cmin: ↑ 167% Cmax: ↑ 108%
English: • changes to your urine
Croatian: • promjene mokraće.
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil.
Croatian: Klinički značajne farmakokinetičke razlike vezane uz etničku pripadnost nisu ustanovljene za kobicistatom pojačani elvitegravir, emtricitabin i tenofovirdizoproksil.
English: Clinical monitoring is recommended due to the potential for hyperkalemia.
Croatian: Zbog moguće pojave hiperkalijemije preporučuje se kliničko praćenje.
English: rosuvastatin, atorvastatin, pravastatin, fluvastatin and pitavastatin
Croatian: • lijekove koji snižavaju kolesterol, kao što su: rosuvastatin, atorvastatin, pravastatin, fluvastatin i pitavastatin
English: (may affect up to 1 in every 1,000 patients treated)
Croatian: (mogu se javiti u do 1 na svakih 1000 liječenih bolesnika)
English: Patients who experience a confirmed increase in serum creatinine of greater than 26.5 µmol/L (0.3 mg/dL) from baseline should be closely monitored for renal safety.
Croatian: Bolesnike koji su iskusili potvrđeni porast serumskog kreatinina veći od 26,5 µmol/l (0,3 mg/dl) u odnosu na početne vrijednosti mora se pomno nadzirati zbog sigurnosti bubrega.
English: Adults with renal impairment
Croatian: Odrasli s oštećenjem bubrega
English: Patients receiving Stribild concomitantly with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir should be monitored for adverse reactions related to tenofovir disoproxil.
Croatian: U bolesnika koji primaju Stribild istodobno s ledipasvirom/sofosbuvirom, sofosbuvirom/velpatasvirom ili sofosbuvirom/velpatasvirom/voksilaprevirom potrebno je pratiti nuspojave povezane s tenofovirdizoproksilom.
English: The use of Stribild is not recommended in paediatric patients with renal impairment (see section 4.2).
Croatian: Liječenje Stribildom ne preporučuje se u pedijatrijskih bolesnika s oštećenjem bubrega (vidjeti dio 4.2).
English: Concentrations of clarithromycin and/or cobicistat may be altered with co-administration of Stribild.
Croatian: Koncentracije klaritromicina i/ili kobicistata mogu se izmijeniti s istodobnom primjenom Stribilda.
English: Concentrations of these antiarrhythmic drugs may be increased when co-administered with cobicistat.
Croatian: Koncentracije tih antiaritmika mogu se povećati s istodobnom primjenom kobicistata.
English: No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects.
Croatian: Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira i kobicistata između ispitanika s teškim oštećenjem bubrega i zdravih ispitanika.
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of treatment.
Croatian: Ako se sumnja ili primijete abnormalnosti u funkciji bubrega, preporučuje se konzultacija s nefrologom kako bi se razmotrio privremeni prekid liječenja.