natgillin/translations-raw huggingface dataset:
Co-administration of Vitekta with medicinal products that are strong inducers of CYP3A is contraindicated as the expected decrease in plasma concentrations of elvitegravir can lead to loss of therapeutic effect and possible development of resistance to elvitegravir (see section 4.3). 
Istovremena primjena lijeka Vitekta s lijekovima koji su jaki induktori CYP3A je kontraindicirana jer očekivano smanjenje koncentracija elvitegravira u plazmi može dovesti do gubitka terapijskog učinka i mogućeg razvoja rezistencije na elvitegravir (vidjeti dio 4.3).
No dose adjustment of Vitekta is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B). 
Nije potrebna prilagodba doze lijeka Vitekta u pacijenata s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem jetre.
The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) following multiple doses of elvitegravir plus a ritonavir-boosted protease inhibitor (150 mg elvitegravir with darunavir or fosamprenavir; 85 mg elvitegravir with atazanavir or lopinavir) in HIV-1 infected subjects were 1.4 ± 0.39 μg/mL, 18 ± 6.8 μg•h/mL, and 0.38 ± 0.22 μg/mL for elvitegravir, respectively. 
Srednje vrijednosti Cmax, AUCtau i Ctrough (srednja vrijednost ± SD) u stanju dinamičke ravnoteže nakon višestrukih doza elvitegravira i ritonavirom pojačanog inhibitora proteaze (150 mg elvitegravira s darunavirom ili fosamprenavirom; 85 mg elvitegravira s atazanavirom ili lopinavirom) u ispitanika zaraženih HIV-1-om bile su 1,4 ± 0,39 µg/ml, odnosno 18 ± 6,8 µg•h/ml, i 0,38 ± 0,22 µg/ml za elvitegravir.
Table 3: Tabulated summary of adverse reactions to elvitegravir based on experience for 96 weeks from clinical study GS-US-183-0145 
Tablica 3: Tablični sažetak nuspojava na elvitegravir na temelju iskustava u trajanju od 96 tjedana iz kliničkog ispitivanja GS-US-183-0145
Lopinavir/Ritonavir (400/100 mg twice daily) 
Lopinavir/ritonavir (400/100 mg dvaput na dan)
Dose of co-administered ritonavir-boosted protease inhibitor 
Doza istovremenoprimijenjenog ritonavirom pojačanim inhibitorom proteaze
85 mg once daily atazanavir 300 mg and ritonavir 100 mg once daily lopinavir 400 mg and ritonavir 100 mg twice daily 
85 mg jedanput na dan atazanavir 300 mg i ritonavir 100 mg jedanput na dan lopinavir 400 mg i ritonavir 100 mg dvaput na dan
Elvitegravir + background regimen n = 351 
Elvitegravir + pozadinski režim n = 351
Co-administration of elvitegravir with oral contraceptives containing progestagens other than norgestimate have not been studied and, therefore, should be avoided. 
Istovremena primjena elvitegravira s oralnim kontraceptivima koji sadrže druge progestagene umjesto norgestimata, nije ispitana te se stoga mora izbjegavati.
Psychiatric disorders: 
Psihijatrijski poremećaji: Manje često:
150 mg once daily darunavir 600 mg and ritonavir 100 mg twice daily fosamprenavir 700 mg and ritonavir 100 mg twice daily 
150 mg jedanput na dan darunavir 600 mg i ritonavir 100 mg dvaput na dan fosamprenavir 700 mg i ritonavir 100 mg dvaput na dan
In an analysis of HIV-1 isolates from treatment-failure subjects in study GS-US-183-0145 through week 96, the development of one or more primary elvitegravir resistance-associated substitutions was observed in 23 of the 86 subjects with evaluable genotypic data from paired baseline and elvitegravir treatment-failure isolates (23/351 elvitegravir-treated subjects, 6.6%). 
U analizi izolata HIV-1 u ispitanika s neuspješnim liječenjem u ispitivanju GS-US-183-0145 u trajanju od 96 tjedana, razvoj jednog ili više primarnih supstitucija povezanih s rezistencijom na elvitegravir zapažen je u 23 od 86 ispitanika s procjenjivim genotipskim podacima iz uparenih početnih izolata i izolata iz neuspješnog liječenja elvitegravirom (23/351 ispitanika liječenih elvitegravirom, 6,6%).
In these combinations the dose is one 150 mg tablet each day, with food. 
U tim kombinacijama doza je jedna tableta od 150 mg uzeta s hranom svaki dan.
No dose adjustment of Vitekta is required when co-administered with reduced dose of rifabutin. 
Prilagodba doze lijeka Vitekta nije potrebna kada se istovremeno primjenjuje sa smanjenom dozom rifabutina.
In these combinations the dose is one 85 mg tablet each day, with food. 
U tim kombinacijama doza je jedna tableta od 85 mg uzeta s hranom svaki dan.
Mechanism of action and pharmacodynamic effects Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). 
Elvitegravir je inhibitor prijenosa lanca HIV-1 integraze (INSTI).
Co-administration of Vitekta and related active substances: Vitekta must be used in combination with a ritonavir-boosted protease inhibitor. 
Istovremena primjena lijeka Vitekta i srodnih djelatnih tvari: Vitekta se mora primjenjivati u kombinaciji s ritonavirom pojačanim inhibitorom proteaze.
126/202 (62.4%) 122/207 (58.9%) 3.4% (-6.0% to 12.9%) 2.9% (-13.7% to 19.6%) 
126/202 (62,4%) 122/207 (58,9%) 3,4% (-6,0% do 12,9%)
No data are available on which to make a dose recommendation for patients over the age of 65 years 
Nema dostupnih podataka na osnovi kojih bi se mogla preporučiti doza za pacijente starije od 65 godina (vidjeti dio 5.2).
Recommendation concerning co-administration with ritonavir-boosted elvitegravir 
Preporuka za istovremenu primjenu s ritonavirom pojačanim elvitegravirom
The use of Vitekta with HIV-1 protease inhibitors or dosing frequencies other than those presented in Table 1 may result in inadequate or elevated plasma levels of elvitegravir and/or the co-administered medicinal products. 
Primjena lijeka Vitekta s inhibitorima proteaze HIV-1 ili učestalošću doziranja koji nisu navedeni u tablici 1 može rezultirati neodgovarajućim ili povišenim razinama elvitegravira i/ili istovremeno primijenjenih lijekova u plazmi.
Raltegravir + background regimen n = 351 
Raltegravir + pozadinski režim n = 351
This study was conducted using the fixed-dose combination tablet elvitegravir/cobicistat/emtricitabine/tenofovir 
Ovo ispitivanje provedeno je uz primjenu tableta s kombinacijom fiksne doze elvitegravira/kobicistata/emtricitabina/tenofovirdizoproksila.
No dose adjustment is required when Vitekta is co-administered with tenofovir disoproxil fumarate or with emtricitabine. 
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s tenofovirdizoproksilfumaratom ili s emtricitabinom.
Vitekta is indicated for use only when co-administered with 
Vitekta je indicirana za primjenu samo kada se istovremeno primjenjuje s ritonavirom
For use of the 150 mg tablet, please refer to the Summary of Product Characteristics for Vitekta 150 mg tablets. 
Za primjenu tablete od 150 mg, molimo pročitajte Sažetak opisa svojstava lijeka za Vitekta 150 mg tablete.
A study of the pharmacokinetics of boosted elvitegravir was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B). 
Ispitivanje farmakokinetike pojačanog elvitegravira provedeno je na ispitanicima koji nisu zaraženi s HIV-1, a koji imaju umjereno oštećenje funkcije jetre (Child-Pugh stadij B).
Baseline characteristics and treatment outcomes through 96 weeks for study GS-US-183-0145 are presented in Tables 4 and 5 respectively. 
Početne značajke i ishodi liječenja kroz 96 tjedana ispitivanja GS-US-183-0145 prikazani su u tablici 4, odnosno tablici 5.
Elvitegravir undergoes oxidative metabolism by CYP3A (major route), and glucuronidation via UGT1A1/3 enzymes (minor route). 
Elvitegravir prolazi kroz oksidativni metabolizam putem CYP3A (glavni put) i kroz glukuronidaciju putem UGT1A1/3 enzima (sporedni put).
No interactions were studied using unboosted elvitegravir. 
Interakcije nisu ispitane primjenom nepojačanog elvitegravira.
 If any of these applies to you, talk to your doctor before taking Vitekta. 
Ako se išta od ovog odnosi na Vas, razgovarajte sa svojim liječnikom prije nego uzmete lijek
The frequency of the following side effects is not known (frequency cannot be estimated from the 
Drugi učinci koji se mogu vidjeti tijekom liječenja HIV-a Učestalost sljedećih nuspojava nije poznata (učestalost se ne može procijeniti iz dostupnih podataka):
Uncommon dizziness, paraesthesia, somnolence, dysgeusia abdominal pain, diarrhoea, vomiting, nausea dyspepsia, abdominal distension, flatulence 
bol u abdomenu, proljev, povraćanje, mučnina dispepsija, distenzija abdomena, flatulencija Poremećaji kože i potkožnog tkiva:
Vitekta should not be used in combination with products containing elvitegravir or pharmacokinetic 
Vitekta se ne smije primjenjivati u kombinaciji s lijekovima koji sadrže elvitegravir ili pojačavaju farmakokinetiku, osim ritonavira.
Atazanavir/ritonavir and lopinavir/ritonavir have been shown to significantly increase the plasma concentrations of elvitegravir (see section 4.5). 
Pokazalo se da atazanavir/ritonavir i lopinavir/ritonavir značajno povećavaju koncentracije elvitegravira u plazmi (vidjeti dio 4.5).
4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection. 
Terapiju mora započeti liječnik s iskustvom u liječenju HIV infekcije.
Table 5: Virologic outcome of randomised treatment of study GS-US-183-0145 at week 48 and week 96 (snapshot analysis) 
Tablica 5: Virološki ishod randomiziranog liječenja u ispitivanju GS-US-183-0145 u 48. tjednu i 96. tjednu (analiza snimaka)
Therefore, Vitekta should not be used during breast 
Stoga se Vitekta ne bi trebala primjenjivati tijekom
For use of the 85 mg tablet, please refer to the Summary of Product Characteristics for Vitekta 85 mg tablets. 
Za primjenu tablete od 85 mg, molimo pročitajte Sažetak opisa svojstava lijeka za Vitekta 85 mg tablete.
Virologic success HIV-1 RNA < 50 copies/mL 
Virološki uspjeh HIV-1 RNK < 50 kopija/ml Razlika u liječenju
In study GS-US-183-0145, the mean increase from baseline in CD4+ cell count at week 96 was in the elvitegravir-treated patients and 198 cells/mm in the raltegravir-treated patients. 
U ispitivanju GS-US-183-0145 srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ u 96. tjednu bilo je 205 stanica/mm³ u pacijenta liječenih elvitegravirom i 198 stanica/mm³ u pacijenata liječenih raltegravirom.
Green, pentagon-shaped, film-coated tablet of dimensions 8.9 mm x 8.7 mm, debossed with “GSI” on one side of the tablet and “85” on the other side of the tablet. 
Zelena, filmom obložena tableta u obliku peterokuta veličine 8,9 mm x 8,7 mm, s utisnutom oznakom „GSI“ na jednoj strani i brojem „85“ na drugoj strani tablete.
Elvitegravir did not show any carcinogenic potential in long-term oral carcinogenicity studies in mice 
Dugotrajna ispitivanja kancerogenosti elvitegravira nisu pokazala kancerogenosti potencijal u miševa i
Following oral administration of a single dose of ritonavir-boosted [ 
Nakon peroralne primjene jednokratne doze ritonavirom pojačanog [
No clinically relevant differences in elvitegravir pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects. 
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira između ispitanika s teškim oštećenjem funkcije bubrega i zdravih ispitanika.
No dose adjustment is required when Vitekta is co-administered with atorvastatin, fluvastatin, pitavastatin or pravastatin. 
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s atorvastatinom, fluvastatinom, pitavastatinom ili pravastatinom.
HIV protease inhibitors Atazanavir (300 mg once daily) 
Inhibitori proteaze HIV-a Atazanavir (300 mg jedanput na dan)
Green, triangle-shaped, film-coated tablet of dimensions 10.9 mm x 10.5 mm, debossed with “GSI” on one side of the tablet and “150” on the other side of the tablet. 
Zelena, filmom obložena tableta u obliku trokuta veličine 10,9 mm x 10,5 mm, s utisnutom oznakom „GSI“ na jednoj strani i brojem „150“ na drugoj strani tablete.
No dose adjustment is required when Vitekta is co-administered with ritonavir-boosted atazanavir plus telaprevir. 
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s atazanavirom pojačanim ritonavirom uz telaprevir.
Among subjects with a genotypic sensitivity score > 1, 57% and 56% had HIV-1 RNA < 50 copies/mL at week 48 in the elvitegravir and raltegravir treatment arms, respectively. 
Ispitanici s rezultatom genotipske osjetljivosti > 1, 57% i 56% ispitanika imalo je HIV-1 RNK < 50 kopija/ml u 48. tjednu u skupini na elvitegraviru, odnosno u skupini na raltegraviru.
Do not change the dose unless your doctor tells you to. You must always take Vitekta with one of the following combinations of medicines: 
Lijek Vitekta morate uvijek uzimati s jednom od sljedećih kombinacija lijekova:
Table 6: Virologic success by co-administered protease inhibitor in study GS-US-183-0145 at week 48 and week 96 (snapshot analysis) 
Tablica 6: Virološki uspjeh istovremeno primijenjenog inhibitora proteaze u ispitivanju GS-US-183-0145 u 48. tjednu i 96. tjednu (analiza snimaka)
• suicidal thoughts and suicide attempts (in patients who have had depression or mental health 
(mogu se javiti u manje od 1 osobe na svakih 100 liječenih bolesnika) • suicidalne misli i pokušaji samoubojstva (u bolesnika koji su i ranije imali depresiju ili tegobe s
Titanium dioxide (E171) Iron oxide yellow (E172) 
boja indigo carmine aluminium lake (E132) poli(vinilni alkohol) (djelomično hidroliziran) (E1203) titanijev dioksid (E171) željezov oksid, žuti (E172)
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). 
Elvitegravir je pokazao antivirusnu aktivnost u staničnoj kulturi na HIV-1 podtipove A, B, C, D, E, F, G i O (vrijednosti EC50 u rasponu od 0,1 do 1,3 nM) i aktivnost na HIV-2 (EC50 od 0,53 nM).
Among subjects with a genotypic sensitivity score of ≤ 1, 76% and 69% had HIV-1 RNA < 50 copies/mL at week 48 in the elvitegravir and raltegravir treatment arms, respectively. 
Ispitanici s rezultatom genotipske osjetljivosti ≤ 1, 76% i 69% ispitanika imalo je HIV-1 RNK < 50 kopija/ml u 48. tjednu u skupini na elvitegraviru, odnosno u skupini na raltegraviru.
The film-coated tablet should 
Filmom obložena tableta (tableta).
Accordingly, when used in combination with atazanavir/ritonavir and lopinavir/ritonavir, the dose of Vitekta should be decreased from 150 mg once daily to 85 mg once daily (see sections 4.2 and 4.4). 
Shodno tomu, kada se primjenjuje u kombinaciji s atazanavirom/ritonavirom i lopinavirom/ritonavirom, doza lijeka Vitekta mora se smanjiti sa 150 mg jedanput na dan na 85 mg jedanput na dan (vidjeti dijelove 4.2 i 4.4).
Talk to your doctor if you are taking: • rifabutin, used to treat bacterial infections including tuberculosis 
• rifabutin, koji se primjenjuje za liječenje bakterijskih infekcija, uključujući tuberkulozu
No dose adjustment of Vitekta is necessary for patients with mild to moderate hepatic impairment. 
Nije potrebna prilagodba doze lijeka Vitekta za pacijente s blagim do umjerenim oštećenjem funkcije jetre.
There are no data available to make dosing recommendations for co-administration with other doses of lopinavir/ritonavir (see section 4.2). 
Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama lopinavira/ritonavira (vidjeti dio 4.2).
The frequency of this is unknown 
Učestalost nije poznata (vidjeti
Vitekta 150 mg [Outer packaging only] 
16. PODACI NA BRAILLEOVOM PISMU Vitekta 150 mg [samo vanjsko pakiranje]
Vitekta film-coated tablets are green, triangle-shaped tablets, debossed on one side with “GSI” and “150” on the other side of the tablet. 
Vitekta filmom obložene tablete su zelene tablete u obliku trokuta, s utisnutom oznakom „GSI“ na jednoj strani i brojem „150“ na drugoj strani tablete.
Lopinavir/Ritonavir has been shown to significantly increase the plasma concentrations of elvitegravir. 
Pokazalo se da lopinavir/ritonavir značajno povećavaju koncentracije elvitegravira u plazmi.
No clinically relevant differences in elvitegravir pharmacokinetics were observed between subjects with moderate impairment and healthy subjects. 
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira između ispitanika s umjerenim oštećenjem funkcije jetre i zdravih ispitanika.
Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with hepatitis B virus (HBV). 
U cilju optimalnog liječenja HIV infekcije u pacijenata koji su istovremeno zaraženi virusom hepatitisa B (HBV), liječnici se moraju pridržavati trenutačno važećih smjernica za liječenje HIV-a.
No clinically relevant pharmacokinetic differences due to gender have been identified for boosted 
Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za pojačani elvitegravir.
Plasma concentrations of OATP substrates are not expected to change upon co-administration of elvitegravir. 
Koncentracije supstrata polipeptida koji transportira organske anione (OATP) u plazmi očekivano se ne mijenjaju nakon istovremene primjene elvitegravira.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 85 mg of elvitegravir. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 85 mg elvitegravira.
Elvitegravir (simultaneous 
Elvitegravir (istodobna primjena antacida):
• cobicistat 
• kobicistat
Refer to the package leaflet for Vitekta 150 mg tablets. 
Pročitajte Uputu o lijeku za Vitekta 150 mg tablete.
Elvitegravir (125 mg once daily) 
Elvitegravir (125 mg jedanput na dan)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of elvitegravir. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 150 mg elvitegravira.
Vitekta 85 mg film-coated tablets Elvitegravir 
Vitekta 85 mg filmom obložene tablete elvitegravir
It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Vitekta. 
U slučaju istovremene primjene lijeka Vitekta preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
Vitekta 150 mg film-coated tablets Elvitegravir 
Vitekta 150 mg filmom obložene tablete elvitegravir
Cmin: ↔ Abacavir: AUC: ↔ Cmax: ↔ 
Cmin: ↔ Abakavir: AUC: ↔ Cmax: ↔
Vitekta film-coated tablets are green, pentagon-shaped tablets, debossed on one side with “GSI” and “85” on the other side of the tablet. 
Vitekta filmom obložene tablete su zelene tablete u obliku peterokuta, s utisnutom oznakom „GSI“ na jednoj strani i brojem „85“ na drugoj strani tablete.
Vitekta 85 mg film-coated tablets 
Vitekta 85 mg filmom obložene tablete
 If you think that you may have any of these side effects, talk to your doctor. 
Ako mislite da imate neku od ovih nuspojava, obavijestite svog liječnika.
When used in combination with atazanavir/ritonavir and lopinavir/ritonavir, the dose of Vitekta should be decreased from 150 mg once daily to 85 mg once daily (see section 4.2). 
Kada se primjenjuje u kombinaciji s atazanavirom/ritonavirom i lopinavirom/ritonavirom, doza lijeka Vitekta mora se smanjiti s 150 mg jedanput na dan na 85 mg jedanput na dan (vidjeti dio 4.2).
There are no data available to make dosing recommendations for co-administration with other doses of darunavir (see section 4.2). 
Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama darunavira (vidjeti dio 4.2).
Look out for signs of inflammation or infection soon after you start taking Vitekta. 
Odmah nakon početka uzimanja lijeka Vitekta pazite na znakove upale ili infekcije.
No dose adjustment is required when Vitekta is co-administered with ketoconazole. 
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s ketokonazolom.
When used in combination with atazanavir, the dose of Vitekta should be 85 mg once daily. 
Kada se primjenjuje u kombinaciji s atazanavirom, doza lijeka Vitekta mora biti 85 mg jedanput na dan.
When used in combination with darunavir, the dose of Vitekta should be 150 mg once daily. 
Kada se primjenjuje u kombinaciji s darunavirom, doza lijeka Vitekta mora biti 150 mg jedanput na dan.
No dose adjustment of Vitekta is required for patients with renal impairment. 
Nije potrebna prilagodba doze lijeka Vitekta u pacijenata s oštećenjem funkcije bubrega.
Women of childbearing potential / contraception in males and females The use of Vitekta must be accompanied by the use of effective contraception (see sections 4.4 and 4.5). 
Uz primjenu lijeka Vitekta mora se koristiti učinkovita kontracepcija (vidjeti dijelove 4.4 i 4.5).
Please refer to the Summary of Product Characteristics for Vitekta 85 mg 
Pročitajte Sažetak opisa svojstava lijeka za Vitekta 85 mg
Vitekta 150 mg film-coated tablets 
Vitekta 150 mg filmom obložene tablete
Gilead Sciences International Limited Cambridge 
Gilead Sciences Intl Ltd Cambridge
No dose adjustment of Vitekta is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B) (see sections 4.2 and 5.2). 
U pacijenata s blagim (Child-Pugh stadij A) i umjerenim (Child-Pugh stadij B) oštećenjem jetre nije potrebna prilagodba doze lijeka Vitekta (vidjeti dijelove 4.2 i 5.2).
-21.4% (-73.6% to 30.7%) 
1,6% (-33,0% do 36,2%) -21,4% (-73,6% do 30,7%)
Although limited by the small number of female subjects in study GS-US-183-0145, subgroup analysis by gender showed that the rates of virologic success in female subjects at weeks 48 and 96 (HIV-1 RNA < 50 copies/mL) were numerically lower in the elvitegravir treatment arm than in the raltegravir treatment arm. Virologic success rates at week 48 for elvitegravir and raltegravir were 47.5% (28/59) and 62.7% (42/67) (difference: -12.3% [95% CI: -30.1% to 5.5%]), respectively, for female subjects, and 62.3% (182/292) and 56.3% (160/284) (difference: 5.3% [95% CI: -2.5% to 13.2%]), respectively, for male subjects. 
Stope virološkog uspjeha u 48. tjednu za elvitegravir i raltegravir bile su 47,5% (28/59), odnosno 62,7% (42/67) (razlika: -12,3% [95% CI: -30,1% do 5,5%]) za ispitanice, a za ispitanike 62,3% (182/292), odnosno 56,3% (160/284) (razlika: 5,3% [95% CI: -2,5% do 13,2%]).
-11.1% (-45.7% to 23.4%) 
-11,1% (-45,7% do 23,4%) 7,1% (-47,1% do 61,4%)
Elvitegravir 
Nuspojava
When used in combination with lopinavir/ritonavir, the dose of Vitekta should be 85 mg once daily. 
Kada se primjenjuje u kombinaciji s lopinavirom/ritonavirom, doza lijeka Vitekta mora biti 85 mg jedanput na dan.
When used in combination with fosamprenavir, the dose of Vitekta should be 150 mg once daily. 
Kada se primjenjuje u kombinaciji s fosamprenavirom, doza lijeka Vitekta mora biti 150 mg jedanput na dan.
• atazanavir and ritonavir 
• atazanavir i ritonavir
There are no data available to make dosing recommendations for co-administration with other doses of atazanavir (see section 4.2). 
Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama atazanavira (vidjeti dio 4.2).
Refer to the package leaflet for Vitekta 85 mg tablets. 
Pročitajte Sažetak opisa svojstava lijeka za Vitekta 85 mg tablete.
Ketoconazole (200 mg twice daily) Elvitegravir (150 mg once daily) Ritonavir (100 mg once daily) 
Ketokonazol (200 mg dvaput na Elvitegravir (150 mg jedanput na Ritonavir (100 mg jedanput na dan)
Each film-coated tablet contains 85 mg elvitegravir. 
Jedna filmom obložena tableta sadrži 85 mg elvitegravira.
No dose adjustment is required when Vitekta is co-administered with famotidine. 
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s famotidinom.
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Sažetak profila sigurnosti primjene
• fosamprenavir and ritonavir 
• fosamprenavir i ritonavir
No dose adjustment is required when Vitekta is co-administered with etravirine. 
Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s etravirinom.