FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, no tenofovir disoproxil dose adjustment is required in patients with hepatic impairment.
Croatian: Stoga, nije potrebna prilagodba doze tenofovirdizoproksil u bolesnika s oštećenjem funkcije jetre.
English: Stribild met the non-inferiority criteria in achieving HIV-1 RNA < 50 copies/mL when compared to efavirenz/emtricitabine/tenofovir disoproxil and when compared to atazanavir/ritonavir + emtricitabine/tenofovir disoproxil.
Croatian: U usporedbi sa skupinom efavirenz / emtricitabin / tenofovirdizoproksil i skupinom atazanavir/ritonavir + emtricitabin / tenofovirdizoproksil, Stribild je ispunio kriterije neinferiornosti u postizanju vrijednosti HIV-1 RNK < 50 kopija/ml.
English: The pharmacokinetics of emtricitabine and tenofovir are altered in subjects with renal impairment.
Croatian: Farmakokinetika emtricitabina i tenofovira izmijenjena je u ispitanika s oštećenjem bubrega.
English: That 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: Da bolesnike koji su iskusili potvrđeni porast serumskog kreatinina veći od 26,5 µmol/l (0,3 mg/dl) u odnosu na početne vrijednosti se mora pomno nadzirati zbog sigurnosti bubrega.
English: That patients should have creatinine clearance calculated and urine glucose and urine protein determined prior to initiating Stribild therapy.
Croatian: Da se mora izračunati klirens kreatinina te utvrditi glukozu i proteine u urinu u svih bolesnika prije početka terapije Stribildom.
English: Exacerbations of hepatitis after discontinuation of treatment In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis have occurred after discontinuation of treatment (see section 4.4).
Croatian: U bolesnika s HIV-om koji su istodobno imali infekciju HBV-om, nakon prekida liječenja hepatitis se mogao klinički i laboratorijski dokazati (vidjeti dio 4.4).
English: Therefore, Stribild is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Stoga, primjena Stribilda se ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: ORAL CONTRACEPTIVES Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/Cobicistat (150 mg once daily)
Croatian: Drospirenon/etinilestradiol (jedna doza od 3 mg/0,02 mg)/kobicistat (150 mg jedanput na dan)
English: 3 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Croatian: 3 Ova nuspojava može nastati kao posljedica proksimalne bubrežne tubulopatije.
English: • If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir, tenofovir disoproxil,
Croatian: • ako ste alergični na elvitegravir, kobicistat, emtricitabin, tenofovir, tenofovirdizoproksil ili neki drugi sastojak ovog lijeka (navedeni u dijelu 6 ove upute).
English: • anticoagulants, used to prevent and treat blood clots, such as: warfarin, edoxaban, apixaban and rivaroxaban
Croatian: • antikoagulanse, primjenjuju se za sprječavanje i liječenje krvnih ugrušaka, kao što su: varfarin, edoksaban, apiksaban and rivaroksaban bronhodilatatore, primjenjuju se za liječenje astme i drugih tegoba s plućima:
English: Recommendation concerning co-administration with Stribild
Croatian: Preporuka za istodobnu primjenu sa Stribildom
English: Co-administration with Stribild may result in increased plasma concentrations of sildenafil and tadalafil, which may result in PDE-5 inhibitor-associated adverse reactions.
Croatian: Istodobna primjena Stribilda može za posljedicu imati povećane koncentracije sildenafila i tadalafila u plazmi, što može dovesti do nuspojava povezanih s inhibitorom
English: EFV/ FTC/ tenofovir disoproxil n = 352
Croatian: EFV/FTC/tenofovirdizoproksil n = 352
English: The active substances elvitegravir, cobicistat and tenofovir disoproxil are persistent in the environment.
Croatian: Djelatne tvari elvitegravir, kobicistat i tenofovirdizoproksil nisu razgradive u okolišu.
English: Norgestimate (0.180/0.215 mg once daily)/Ethinyloestradiol (0.025 mg once daily)/
Croatian: Norgestimat (0,180/0,215 mg jedanput na dan) / etinilestradiol (0,025 mg jedanput na dan) / Elvitegravir (150 mg jedanput na dan) / kobicistat (150 mg jedanput na dan)4
English: In Study GS-US-236-0102, the mean increase from baseline in CD4+ cell count at Week 48 was 239 cells/mm3 in the Stribild-treated patients and 206 cells/mm3 in the EFV/FTC/tenofovir disoproxiltreated patients.
Croatian: U ispitivanju GS-US-236-0102, srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ u 48. tjednu bila je 239 stanica/mm³ u bolesnika liječenih Stribildom i 206 stanica/mm³ u bolesnika liječenih EFV/FTC/tenofovirdizoproksilom.
English: In patients who received treatment with tenofovir disoproxil, or stavudine or zidovudine, mean lumbar spine BMD Z-score was -1.034 and -0.498, and mean total body BMD Z-score was -0.471 and -0.386, respectively, at baseline.
Croatian: Početna srednja Z-vrijednost BMD-a lumbalne kralježnice u bolesnika koji su bili liječeni tenofovirdizoproksilom iznosila je -1,034, a u liječenih stavudinom ili zidovudinom -0,498, dok je početna srednja Z-vrijednost BMD-a cijelog tijela u bolesnika liječenih tenofovirdizoproksilom iznosila -0,471, a u liječenih stavudinom ili zidovudinom -0,386.
English: The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Croatian: Djelatne tvari su elvitegravir, kobicistat, emtricitabin i tenofovirdizoproksil.
English: Ethinyloestradiol: AUC: ↓ 25% Cmin: ↓ 44%
Croatian: Etinilestradiol: AUC: ↓ 25% Cmin: ↓ 44% Cmax: ↔
English: Antimycobacterials Rifabutin (150 mg every other day)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Croatian: Antimikobakterijski lijekovi Rifabutin (150 mg svaki drugi dan) / elvitegravir (150 mg jedanput na dan) / kobicistat (150 mg jedanput na dan)
English: Clinical monitoring is recommended upon co-administration of Stribild.
Croatian: Klinički nadzor preporučuje se kod istodobne primjene Stribilda.
English: The use of Stribild is not recommended in paediatric patients with renal impairment (see sections 4.2 and 4.4).
Croatian: Ne preporučuje se primjena Stribilda u pedijatrijskih bolesnika s oštećenom funkcijom bubrega (vidjeti dijelove 4.2 i 4.4).
English: Concentrations of telithromycin and/or cobicistat may be altered with co-administration of Stribild.
Croatian: Koncentracije telitromicina i/ili kobicistata mogu se izmijeniti s istodobnom primjenom Stribilda.
English: Therefore, therapy with Stribild should not be initiated during pregnancy, and women who become pregnant during therapy with Stribild should be switched to an alternative regimen (see sections 4.4 and 4.6).
Croatian: Stoga se terapija Stridbildom ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije Stridbildom treba prebaciti na drugi režim (vidjeti dijelove 4.4 i 4.6).
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Croatian: U skupinama liječenima tenofovirdizoproksilom odnosno stavudinom ili zidovudinom, srednje vrijednosti promjene u 48. tjednu (na kraju randomizirane faze) iznosile su 0,032 odnosno 0,087 za Z-vrijednost BMD-a lumbalne kralježnice i -0,184 odnosno -0,027 za Z-vrijednost BMD-a cijelog tijela.
English: Each Stribild film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Croatian: Jedna filmom obložena tableta Stribilda sadržava 150 mg elvitegravira, 150 mg kobicistata, 200 mg emtricitabina i 245 mg tenofovirdizoproksila (što odgovara 300 mg tenofovirdizoproksilfumarata ili 136 mg tenofovira).
English: The mean increase from baseline in CD4+ cell count at Week 48 was 56 cells/mm3 in the Stribild-treated patients and 58 cells/mm3 in the NNRTI+FTC/tenofovir disoproxil-treated patients.
Croatian: Srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ u 48. tjednu bila je 56 stanica/mm3 u bolesnika liječenih Stribildom i 58 stanica/mm3 u bolesnika liječenih NNRTI+FTC/tenofovirdizoproksilom.
English: AUC: ↔ Cmax: ↔ Cmin: ↑ 71%
Croatian: Kobicistat: AUC: ↔ Cmax: ↔ Cmin: ↑ 71%
English: Therefore, therapy with Stribild should not be initiated during pregnancy, and women who become pregnant during therapy with Stribild should be switched to an alternative regimen (see sections 4.2 and 4.6).
Croatian: Stoga terapija Stridbildom ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije Stridbildom treba prebaciti na drugi režim (vidjeti dijelove 4.2 i 4.6).
English: Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Croatian: Jedna filmom obložena tableta sadržava 150 mg elvitegravira, 150 mg kobicistata, 200 mg emtricitabina i 245 mg tenofovirdizoproksila (što odgovara 300 mg tenofovirdizoproksilfumarata ili 136 mg tenofovira).
English: The safety of Stribild in 50 HIV-1-infected, treatment-naïve paediatric patients aged 12 to < 18 years was evaluated through 48 weeks in an open-label clinical study (GS-US-236-0112, see section 5.1).
Croatian: Sigurnost lijeka Stribild ispitana je u otvorenom kliničkom ispitivanju u trajanju od 48 tjedana na 50 pedijatrijskih bolesnika u dobi od 12 do 18 godina zaraženih virusom HIV-1 koji prethodno nisu bili liječeni (GS-US-236-0112, vidjeti dio 5.1).
English: Therefore, therapy with Stribild should not be initiated during pregnancy, and women who become pregnant during therapy with Stribild should be switched to an alternative regimen (see sections 4.2 and 4.4).
Croatian: Stoga terapija Stridbildom ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije Stridbildom treba prebaciti na drugi režim (vidjeti dijelove 4.2 i 4.4).
English: At Week 144, the mean increase from baseline in CD4+ cell count was 321 cells/mm3 in the Stribild-treated patients and 300 cells/mm3 in the EFV/FTC/tenofovir disoproxil-treated patients.
Croatian: U 144. tjednu, srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ bila je 321 stanica/mm³ u bolesnika liječenih Stribildom i 300 stanica/mm³ u bolesnika liječenih EFV/FTC/tenofovirdizoproksilom.
English: Concentrations of warfarin may be affected upon co-administration with Stribild.
Croatian: Koncentracije varfarina mogu se promijeniti s istodobnom primjenom Stribilda.
English: The mean increase from baseline in CD4+ cell count at Week 48 was 40 cells/mm3 in the Stribild-treated patients and 32 cells/mm3 in the PI+RTV+FTC/tenofovir disoproxil-treated patients.
Croatian: Srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ u 48. tjednu bila je 40 stanica/mm3 u bolesnika liječenih Stribildom i 32 stanice/mm3 u bolesnika liječenih PI+RTV+FTC/tenofovirdizoproksilom.
English: No dose adjustment of Stribild is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment (see sections 4.2 and
Croatian: U bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre nije potrebno prilagođavati dozu Stribilda (vidjeti dijelove 4.2 i 5.2).
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Croatian: Slučajevi akutnog zatajenja bubrega zabilježeni su u bolesnika s čimbenicima rizika za poremećaj funkcije bubrega liječenih tenofovirdizoproksilom, nakon uvođenja visokih doza ili više nesteroidnih antiinflamatornih lijekova (NSAIL).
English: In Study GS-US-236-0103, the mean increase from baseline in CD4+ cell count at Week 48 was 207 cells/mm3 in the Stribild-treated patients and 211 cells/mm3 in the ATV/r+FTC/tenofovir disoproxil-treated patients.
Croatian: U ispitivanju GS-US-236-0103, srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ u 48. tjednu bila je 207 stanica/mm³ u bolesnika liječenih Stribildom i 211 stanica/mm³ u bolesnika liječenih ATV/r + FTC/tenofovirdizoproksilom.
English: No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Croatian: Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira i kobicistata između ispitanika s umjerenim oštećenjem funkcije jetre i zdravih ispitanika.
English: (may affect up to 1 in every 100 patients treated)
Croatian: (mogu se javiti u do 1 na svakih 100 liječenih bolesnika)
English: In Study GS-US-236-0102 HIV-1 infected antiretroviral treatment-naïve adult patients received oncedaily treatment of Stribild or once-daily treatment of fixed-dose combination of EFV/FTC/tenofovir disoproxil.
Croatian: Odrasli bolesnici zaraženi virusom HIV-1 koji prethodno nisu bili liječeni U ispitivanju GS-US-236-0102 odrasli bolesnici zaraženi virusom HIV-1 koji prije nisu bili liječeni antiretrovirusnim lijekovima primali su Stribild jedanput dnevno ili kombinaciju EFV/FTC/tenofovirdizoproksil u fiksnoj dozi jedanput dnevno.
English: Concentrations of trazodone may increase upon co-administration with cobicistat.
Croatian: Koncentracije trazodona mogu se povećati tijekom istodobne primjene s kobicistatom.
English: Sofosbuvir: AUC: ↔ Cmax: ↑ 27% Cmin: N/A
Croatian: Sofosbuvir: AUC: ↔ Cmax: ↑ 27%
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicinal products are concomitantly administered with Stribild.
Croatian: U slučaju istodobne primjene Stribilda i ovih lijekova preporučuje se klinički nadzor terapijskih učinaka i nuspojava.
English: • feeling bloated
Croatian: • osjećaj nadutosti
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z-score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Croatian: U bolesnika koji su liječeni tenofovirdizoproksilom ili placebom, srednja Z-vrijednost mineralne gustoće kosti (BMD) u lumbalnoj kralježnici bila je -1,004 odnosno -0,809, a srednja Z-vrijednost
English: ORAL ANTI-DIABETICS Metformin
Croatian: • lijekove za liječenje dijabetesa: metformin
English: At Week 144, the mean increase from baseline in CD4+ cell count was 280 cells/mm3 in the Stribild-treated patients and 293 cells/mm3 in the ATV/r+FTC/tenofovir disoproxil-treated patients.
Croatian: U 144. tjednu, srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ bila je 280 stanica/mm³ u bolesnika liječenih Stribildom i 293 stanice/mm³ u bolesnika liječenih ATV/r + FTC/TDF-om.
English: Clinical monitoring should be made upon co-administration with Stribild.
Croatian: Klinički nadzor mora se primijeniti prilikom istodobne primjene Stribilda.
English: Increased plasma concentrations of tenofovir resulting from co-administration of Stribild and sofosbuvir/velpatasvir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Croatian: Povećane koncentracije tenofovira u plazmi uslijed istodobne primjene Stribilda i sofosbuvira/velpatasvira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
English: ANTICONVULSANTS Carbamazepine (200 mg twice daily)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Croatian: Karbamazepin (200 mg dvaput na dan) / elvitegravir (150 mg jedanput na dan) / kobicistat (150 mg jedanput na dan)
English: EFV/FTC/ tenofovir disoproxil n = 352
Croatian: EFV/ FTC/teno fovirdizo proksil n = 352
English: Increased plasma concentrations of tenofovir resulting from co-administration of Stribild and sofosbuvir/velpatasvir/voxilaprevir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Croatian: Povećane koncentracije tenofovira u plazmi uslijed istodobne primjene Stribilda i sofosbuvira/velpatasvira/voksilap revira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
English: The combination should be used with caution with frequent renal monitoring (see section 4.4).
Croatian: Tu je kombinaciju potrebno koristiti uz oprez i čest nadzor bubrežne funkcije (vidjeti dio 4.4).
English: Caution should be exercised, including consideration of dose reduction, when co-administering Stribild with tadalafil for the treatment of pulmonary arterial hypertension.
Croatian: Istodobna primjena Stribilda i tadalafila za liječenje plućne arterijske hipertenzije mora se provoditi s oprezom, uključujući i razmatranje snižavanja doze.
English: lactic acidosis1
Croatian: laktacidoza1
English: 1 When data available from drug interaction studies.
Croatian: DOAC = direktni oralni antikoagulans 1 Kada su podaci dostupni iz ispitivanja interakcija lijekova.
English: Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with hepatitis B virus (HBV).
Croatian: U cilju optimalnog liječenja infekcije HIV-om u bolesnika koji su istodobno zaraženi virusom hepatitisa B (HBV), liječnici se moraju pridržavati trenutačno važećih smjernica za liječenje HIV-a.
English: Therapeutic monitoring is recommended upon co-administration with Stribild.
Croatian: Terapijski nadzor se preporučuje prilikom istodobne primjene s Stribildom.
English: Clinical monitoring is recommended and a dose decrease may be necessary when these agents are co-administered with Stribild.
Croatian: U slučaju istodobne primjene Stribilda i ovih lijekova preporučuje se klinički nadzor i može biti potrebno smanjenje doze.
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Croatian: Sigurnost tenofovirdizoproksila prilikom primjene uz ledipasvir/sofosbuvir i farmakokinetički pojačivač (npr. kobicistat) nije ustanovljena.
English: Elvitegravir: AUC: ↔ Cmin: ↑ 36%
Croatian: Elvitegravir: AUC: ↔ Cmin: ↑ 36% Cmax: ↔
English: headache, dizziness Gastrointestinal disorders: Very common:
Croatian: glavobolja, omaglica Poremećaji probavnog sustava: Vrlo često:
English: AUC: ↔ Cmin: ↔ Cmax: ↔
Croatian: Kobicistat: AUC: ↔ Cmin: ↔ Cmax: ↔
English: HMG CO-A REDUCTASE INHIBITORS Rosuvastatin (10 mg single dose)/Elvitegravir (150 mg single dose)/Cobicistat (150 mg single dose)
Croatian: Rosuvastatin (jedna doza od 10 mg) / elvitegravir (jedna doza od 150 mg) / kobicistat (jedna doza od 150 mg)
English: Caution is warranted and clinical monitoring is recommended during the co-administration.
Croatian: U slučaju istodobne primjene preporučuju se primjena mjera opreza i klinički nadzor.
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily) + Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil (150 mg/150 mg/200 mg/245 mg once daily)
Croatian: Sofosbuvir/velpatasvir (400 mg/100 mg jedanput na dan) + elvitegravir/kobicistat/ emtricitabin/ tenofovirdizoproksil
English: For patients with ClCr < 60 mL/min, alternative antibacterials should be considered.
Croatian: Zamjenski antibakterijski lijekovi moraju se razmotriti za bolesnike s vrijednošću ClCr < 60 ml/min.
English: Studies with Stribild
Croatian: Klinička ispitivanja Stribilda
English: What is in this leaflet
Croatian: Što Stribild sadrži
English: Naloxone:
Croatian: Norgestimat:
English: NARCOTIC ANALGESICS Methadone/Elvitegravir/Cobicistat Methadone:
Croatian: Metadon/elvitegravir/kobicistat
English: The antiviral activity of elvitegravir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cells, monocyte/macrophage cells, and peripheral blood lymphocytes and the 50% effective concentration (EC50) values were in the range of 0.02 to 1.7 nM. Elvitegravir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.1 to 1.3 nM) and activity against HIV-2 (EC50 of 0.53 nM).
Croatian: Antivirusno djelovanje elvitegravira na laboratorijske i kliničke izolate virusa HIV-1 procijenjeno je na limfoblastoidnim stanicama, monocitnim/makrofagnim stanicama i limfocitima periferne krvi, te su vrijednosti 50%-tne djelotvorne koncentracije (EC50) bile u rasponu od 0,02 do 1,7 nM.
English: Caution is warranted and clinical monitoring is recommended upon co-administration with Stribild.
Croatian: U slučaju istodobne primjene Stribilda preporučuju se primjena mjera opreza i klinički nadzor.
English: AUC: ↔ Cmax: ↔ Cmin: ↑ 37%
Croatian: Velpatasvir: AUC: ↔ Cmax: ↔ Cmin: ↑ 37%
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Croatian: Sigurnost tenofovirdizoproksila prilikom primjene uz sofosbuvir/velpatasvir i farmakokinetički pojačivač (npr. kobicistat) nije ustanovljena.
English: Stribild [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Stribild [Samo vanjsko pakiranje]
English: Lot
Croatian: mle
English: That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any adolescent patient receiving Stribild, renal function should be re-evaluated within one week.
Croatian: Da u adolescentnih bolesnika koji uzimaju Stribild treba ponovno procijeniti funkciju bubrega unutar jednoga tjedna, ako je fosfat u serumu < 3,0 mg/dl (0,96 mmol/l).
English: That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained.
Croatian: 13. Da je potrebna konzultacija s endokrinologom i/ili nefrologom ako se sumnja ili primijete abnormalnosti na kostima.
English: AUC: ↓ 21% Cmin: ↓ 67%
Croatian: Elvitegravir: AUC: ↓ 21% Cmin: ↓ 67% Cmax: ↔
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Croatian: Sigurnost tenofovirdizoproksila prilikom primjene uz sofosbuvir/velpatasvir/voksilapre vir i farmakokinetički pojačivač (npr. kobicistat) nije ustanovljena.
English: Mean changes from baseline BMD Z-scores (height-age adjusted) were −0.09 for lumbar spine and
Croatian: Promjene srednje Z-vrijednosti BMD-a (prilagođena za tjelesnu visinu i godine) u 48. tjednu u odnosu na početnu bile su -0,09 za lumbalnu kralježnicu i -0,12 za cijelo tijelo s izuzetkom glave.
English: Rifabutin: AUC: ↔
Croatian: Sofosbuvir: AUC: ↔ Cmax: ↔
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: Srednja početna vrijednost
English: Skin and subcutaneous tissue disorders: Very common:
Croatian: jetrena steatoza1, hepatitis1 Poremećaji kože i potkožnog tkiva: Vrlo često:
English: IMMUNOSUPPRESSANTS Ciclosporin
Croatian: Ciklosporin Sirolimus Takrolimus
English: Mean age, years (range)
Croatian: ROK VALJANOSTI Rok valjanosti
English: this may cause the child to be tired or breathless
Croatian: to može dovesti do umora i nedostatka zraka.
English: Emtricitabine exposures were unaffected with light or high-fat meal.
Croatian: S laganim i visokomasnim obrocima nije bilo promjena u izloženosti emtricitabinu.
English: AUC: ↑ 48% Cmin: ↑ 67%
Croatian: Elvitegravir: AUC: ↑ 48% Cmin: ↑ 67% Cmax: ↔
English: Caution should be exercised when co-administering Stribild with pitavastatin.
Croatian: Istodobna primjena Stribilda i pitavastatina mora se provoditi s oprezom.
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Croatian: makrogol 3350 (E1521) poli(vinilni alkohol) (djelomično hidroliziran) (E1203) talk (E553B) titanijev dioksid (E171) željezov oksid, žuti (E172)
English: Suspension and emulsion for emulsion for injection
Croatian: Suspenzija i emulzija za emulziju za injekciju
English: EU/1/09/578/001
Croatian: EU/1/09/578/001 Adjupanrix 3.75 µg HA
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Croatian: U mišić suspenzija (H5N1): bočica (staklo)
English: 2.5 ml (suspension)
Croatian: 2,5 ml (suspenzija) 2,5 ml (emulzija)