FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose of co-administered ritonavir-boosted protease inhibitor
Croatian: Doza istovremenoprimijenjenog ritonavirom pojačanim inhibitorom proteaze
English: 85 mg once daily atazanavir 300 mg and ritonavir 100 mg once daily lopinavir 400 mg and ritonavir 100 mg twice daily
Croatian: 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
English: Elvitegravir + background regimen n = 351
Croatian: Elvitegravir + pozadinski režim n = 351
English: Co-administration of elvitegravir with oral contraceptives containing progestagens other than norgestimate have not been studied and, therefore, should be avoided.
Croatian: Istovremena primjena elvitegravira s oralnim kontraceptivima koji sadrže druge progestagene umjesto norgestimata, nije ispitana te se stoga mora izbjegavati.
English: Psychiatric disorders:
Croatian: Psihijatrijski poremećaji: Manje često:
English: 150 mg once daily darunavir 600 mg and ritonavir 100 mg twice daily fosamprenavir 700 mg and ritonavir 100 mg twice daily
Croatian: 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
English: 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%).
Croatian: 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%).
English: In these combinations the dose is one 150 mg tablet each day, with food.
Croatian: U tim kombinacijama doza je jedna tableta od 150 mg uzeta s hranom svaki dan.
English: No dose adjustment of Vitekta is required when co-administered with reduced dose of rifabutin.
Croatian: Prilagodba doze lijeka Vitekta nije potrebna kada se istovremeno primjenjuje sa smanjenom dozom rifabutina.
English: In these combinations the dose is one 85 mg tablet each day, with food.
Croatian: U tim kombinacijama doza je jedna tableta od 85 mg uzeta s hranom svaki dan.
English: Mechanism of action and pharmacodynamic effects Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI).
Croatian: Elvitegravir je inhibitor prijenosa lanca HIV-1 integraze (INSTI).
English: Co-administration of Vitekta and related active substances: Vitekta must be used in combination with a ritonavir-boosted protease inhibitor.
Croatian: Istovremena primjena lijeka Vitekta i srodnih djelatnih tvari: Vitekta se mora primjenjivati u kombinaciji s ritonavirom pojačanim inhibitorom proteaze.
English: 126/202 (62.4%) 122/207 (58.9%) 3.4% (-6.0% to 12.9%) 2.9% (-13.7% to 19.6%)
Croatian: 126/202 (62,4%) 122/207 (58,9%) 3,4% (-6,0% do 12,9%)
English: No data are available on which to make a dose recommendation for patients over the age of 65 years
Croatian: Nema dostupnih podataka na osnovi kojih bi se mogla preporučiti doza za pacijente starije od 65 godina (vidjeti dio 5.2).
English: Recommendation concerning co-administration with ritonavir-boosted elvitegravir
Croatian: Preporuka za istovremenu primjenu s ritonavirom pojačanim elvitegravirom
English: 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.
Croatian: 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.
English: Raltegravir + background regimen n = 351
Croatian: Raltegravir + pozadinski režim n = 351
English: This study was conducted using the fixed-dose combination tablet elvitegravir/cobicistat/emtricitabine/tenofovir
Croatian: Ovo ispitivanje provedeno je uz primjenu tableta s kombinacijom fiksne doze elvitegravira/kobicistata/emtricitabina/tenofovirdizoproksila.
English: No dose adjustment is required when Vitekta is co-administered with tenofovir disoproxil fumarate or with emtricitabine.
Croatian: Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s tenofovirdizoproksilfumaratom ili s emtricitabinom.
English: Vitekta is indicated for use only when co-administered with
Croatian: Vitekta je indicirana za primjenu samo kada se istovremeno primjenjuje s ritonavirom
English: For use of the 150 mg tablet, please refer to the Summary of Product Characteristics for Vitekta 150 mg tablets.
Croatian: Za primjenu tablete od 150 mg, molimo pročitajte Sažetak opisa svojstava lijeka za Vitekta 150 mg tablete.
English: A study of the pharmacokinetics of boosted elvitegravir was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Croatian: 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).
English: Baseline characteristics and treatment outcomes through 96 weeks for study GS-US-183-0145 are presented in Tables 4 and 5 respectively.
Croatian: Početne značajke i ishodi liječenja kroz 96 tjedana ispitivanja GS-US-183-0145 prikazani su u tablici 4, odnosno tablici 5.
English: Elvitegravir undergoes oxidative metabolism by CYP3A (major route), and glucuronidation via UGT1A1/3 enzymes (minor route).
Croatian: Elvitegravir prolazi kroz oksidativni metabolizam putem CYP3A (glavni put) i kroz glukuronidaciju putem UGT1A1/3 enzima (sporedni put).
English: No interactions were studied using unboosted elvitegravir.
Croatian: Interakcije nisu ispitane primjenom nepojačanog elvitegravira.
English:  If any of these applies to you, talk to your doctor before taking Vitekta.
Croatian: Ako se išta od ovog odnosi na Vas, razgovarajte sa svojim liječnikom prije nego uzmete lijek
English: The frequency of the following side effects is not known (frequency cannot be estimated from the
Croatian: Drugi učinci koji se mogu vidjeti tijekom liječenja HIV-a Učestalost sljedećih nuspojava nije poznata (učestalost se ne može procijeniti iz dostupnih podataka):
English: Uncommon dizziness, paraesthesia, somnolence, dysgeusia abdominal pain, diarrhoea, vomiting, nausea dyspepsia, abdominal distension, flatulence
Croatian: bol u abdomenu, proljev, povraćanje, mučnina dispepsija, distenzija abdomena, flatulencija Poremećaji kože i potkožnog tkiva:
English: AUC: ↑ 186% Cmax: ↑ 115% Cmin: ↑ 323%
Croatian: Maravirok:§ AUC: ↑ 186% Cmax: ↑ 115% Cmin: ↑ 323%
English: Vitekta should not be used in combination with products containing elvitegravir or pharmacokinetic
Croatian: Vitekta se ne smije primjenjivati u kombinaciji s lijekovima koji sadrže elvitegravir ili pojačavaju farmakokinetiku, osim ritonavira.
English: Atazanavir/ritonavir and lopinavir/ritonavir have been shown to significantly increase the plasma concentrations of elvitegravir (see section 4.5).
Croatian: Pokazalo se da atazanavir/ritonavir i lopinavir/ritonavir značajno povećavaju koncentracije elvitegravira u plazmi (vidjeti dio 4.5).
English: 4.2 Posology and method of administration Therapy should be initiated by a physician experienced in the management of HIV infection.
Croatian: Terapiju mora započeti liječnik s iskustvom u liječenju HIV infekcije.
English: Table 5: Virologic outcome of randomised treatment of study GS-US-183-0145 at week 48 and week 96 (snapshot analysis)
Croatian: Tablica 5: Virološki ishod randomiziranog liječenja u ispitivanju GS-US-183-0145 u 48. tjednu i 96. tjednu (analiza snimaka)
English: Therefore, Vitekta should not be used during breast
Croatian: Stoga se Vitekta ne bi trebala primjenjivati tijekom
English: For use of the 85 mg tablet, please refer to the Summary of Product Characteristics for Vitekta 85 mg tablets.
Croatian: Za primjenu tablete od 85 mg, molimo pročitajte Sažetak opisa svojstava lijeka za Vitekta 85 mg tablete.
English: Virologic success HIV-1 RNA < 50 copies/mL
Croatian: Virološki uspjeh HIV-1 RNK < 50 kopija/ml Razlika u liječenju
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Elvitegravir did not show any carcinogenic potential in long-term oral carcinogenicity studies in mice
Croatian: Dugotrajna ispitivanja kancerogenosti elvitegravira nisu pokazala kancerogenosti potencijal u miševa i
English: Following oral administration of a single dose of ritonavir-boosted [
Croatian: Nakon peroralne primjene jednokratne doze ritonavirom pojačanog [
English: No clinically relevant differences in elvitegravir pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects.
Croatian: Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira između ispitanika s teškim oštećenjem funkcije bubrega i zdravih ispitanika.
English: No dose adjustment is required when Vitekta is co-administered with atorvastatin, fluvastatin, pitavastatin or pravastatin.
Croatian: Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s atorvastatinom, fluvastatinom, pitavastatinom ili pravastatinom.
English: HIV protease inhibitors Atazanavir (300 mg once daily)
Croatian: Inhibitori proteaze HIV-a Atazanavir (300 mg jedanput na dan)
English: 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.
Croatian: 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.
English: No dose adjustment is required when Vitekta is co-administered with ritonavir-boosted atazanavir plus telaprevir.
Croatian: Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s atazanavirom pojačanim ritonavirom uz telaprevir.
English: 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.
Croatian: 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.
English: Do not change the dose unless your doctor tells you to. You must always take Vitekta with one of the following combinations of medicines:
Croatian: Lijek Vitekta morate uvijek uzimati s jednom od sljedećih kombinacija lijekova:
English: Table 6: Virologic success by co-administered protease inhibitor in study GS-US-183-0145 at week 48 and week 96 (snapshot analysis)
Croatian: Tablica 6: Virološki uspjeh istovremeno primijenjenog inhibitora proteaze u ispitivanju GS-US-183-0145 u 48. tjednu i 96. tjednu (analiza snimaka)
English: • suicidal thoughts and suicide attempts (in patients who have had depression or mental health
Croatian: (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
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Croatian: boja indigo carmine aluminium lake (E132) poli(vinilni alkohol) (djelomično hidroliziran) (E1203) titanijev dioksid (E171) željezov oksid, žuti (E172)
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: 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).
English: 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.
Croatian: 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.
English: The film-coated tablet should
Croatian: Filmom obložena tableta (tableta).
English: 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).
Croatian: 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).
English: Talk to your doctor if you are taking: • rifabutin, used to treat bacterial infections including tuberculosis
Croatian: • rifabutin, koji se primjenjuje za liječenje bakterijskih infekcija, uključujući tuberkulozu
English: No dose adjustment of Vitekta is necessary for patients with mild to moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze lijeka Vitekta za pacijente s blagim do umjerenim oštećenjem funkcije jetre.
English: There are no data available to make dosing recommendations for co-administration with other doses of lopinavir/ritonavir (see section 4.2).
Croatian: Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama lopinavira/ritonavira (vidjeti dio 4.2).
English: The frequency of this is unknown
Croatian: Učestalost nije poznata (vidjeti
English: Vitekta 150 mg [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vitekta 150 mg [samo vanjsko pakiranje]
English: Vitekta film-coated tablets are green, triangle-shaped tablets, debossed on one side with “GSI” and “150” on the other side of the tablet.
Croatian: Vitekta filmom obložene tablete su zelene tablete u obliku trokuta, s utisnutom oznakom „GSI“ na jednoj strani i brojem „150“ na drugoj strani tablete.
English: Lopinavir/Ritonavir has been shown to significantly increase the plasma concentrations of elvitegravir.
Croatian: Pokazalo se da lopinavir/ritonavir značajno povećavaju koncentracije elvitegravira u plazmi.
English: No clinically relevant differences in elvitegravir pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Croatian: Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira između ispitanika s umjerenim oštećenjem funkcije jetre i zdravih ispitanika.
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 HIV infekcije u pacijenata koji su istovremeno zaraženi virusom hepatitisa B (HBV), liječnici se moraju pridržavati trenutačno važećih smjernica za liječenje HIV-a.
English: No clinically relevant pharmacokinetic differences due to gender have been identified for boosted
Croatian: Klinički značajne farmakokinetičke razlike vezane uz spol nisu ustanovljene za pojačani elvitegravir.
English: Plasma concentrations of OATP substrates are not expected to change upon co-administration of elvitegravir.
Croatian: Koncentracije supstrata polipeptida koji transportira organske anione (OATP) u plazmi očekivano se ne mijenjaju nakon istovremene primjene elvitegravira.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 85 mg of elvitegravir.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 85 mg elvitegravira.
English: Elvitegravir (simultaneous
Croatian: Elvitegravir (istodobna primjena antacida):
English: • cobicistat
Croatian: • kobicistat
English: Refer to the package leaflet for Vitekta 150 mg tablets.
Croatian: Pročitajte Uputu o lijeku za Vitekta 150 mg tablete.
English: Elvitegravir (125 mg once daily)
Croatian: Elvitegravir (125 mg jedanput na dan)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of elvitegravir.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 150 mg elvitegravira.
English: Vitekta 85 mg film-coated tablets Elvitegravir
Croatian: Vitekta 85 mg filmom obložene tablete elvitegravir
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Vitekta.
Croatian: U slučaju istovremene primjene lijeka Vitekta preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
English: Vitekta 150 mg film-coated tablets Elvitegravir
Croatian: Vitekta 150 mg filmom obložene tablete elvitegravir
English: Cmin: ↔ Abacavir: AUC: ↔ Cmax: ↔
Croatian: Cmin: ↔ Abakavir: AUC: ↔ Cmax: ↔
English: Vitekta film-coated tablets are green, pentagon-shaped tablets, debossed on one side with “GSI” and “85” on the other side of the tablet.
Croatian: Vitekta filmom obložene tablete su zelene tablete u obliku peterokuta, s utisnutom oznakom „GSI“ na jednoj strani i brojem „85“ na drugoj strani tablete.
English: Vitekta 85 mg film-coated tablets
Croatian: Vitekta 85 mg filmom obložene tablete
English:  If you think that you may have any of these side effects, talk to your doctor.
Croatian: Ako mislite da imate neku od ovih nuspojava, obavijestite svog liječnika.
English: 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).
Croatian: 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).
English: There are no data available to make dosing recommendations for co-administration with other doses of darunavir (see section 4.2).
Croatian: Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama darunavira (vidjeti dio 4.2).
English: Look out for signs of inflammation or infection soon after you start taking Vitekta.
Croatian: Odmah nakon početka uzimanja lijeka Vitekta pazite na znakove upale ili infekcije.
English: No dose adjustment is required when Vitekta is co-administered with ketoconazole.
Croatian: Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s ketokonazolom.
English: When used in combination with atazanavir, the dose of Vitekta should be 85 mg once daily.
Croatian: Kada se primjenjuje u kombinaciji s atazanavirom, doza lijeka Vitekta mora biti 85 mg jedanput na dan.
English: When used in combination with darunavir, the dose of Vitekta should be 150 mg once daily.
Croatian: Kada se primjenjuje u kombinaciji s darunavirom, doza lijeka Vitekta mora biti 150 mg jedanput na dan.
English: No dose adjustment of Vitekta is required for patients with renal impairment.
Croatian: Nije potrebna prilagodba doze lijeka Vitekta u pacijenata s oštećenjem funkcije bubrega.
English: 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).
Croatian: Uz primjenu lijeka Vitekta mora se koristiti učinkovita kontracepcija (vidjeti dijelove 4.4 i 4.5).
English: Please refer to the Summary of Product Characteristics for Vitekta 85 mg
Croatian: Pročitajte Sažetak opisa svojstava lijeka za Vitekta 85 mg
English: Vitekta 150 mg film-coated tablets
Croatian: Vitekta 150 mg filmom obložene tablete
English: Gilead Sciences International Limited Cambridge
Croatian: Gilead Sciences Intl Ltd Cambridge
English: 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).
Croatian: 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).
English: -21.4% (-73.6% to 30.7%)
Croatian: 1,6% (-33,0% do 36,2%) -21,4% (-73,6% do 30,7%)
English: 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.
Croatian: 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%]).
English: -11.1% (-45.7% to 23.4%)
Croatian: -11,1% (-45,7% do 23,4%) 7,1% (-47,1% do 61,4%)
English: Elvitegravir
Croatian: Nuspojava
English: When used in combination with lopinavir/ritonavir, the dose of Vitekta should be 85 mg once daily.
Croatian: Kada se primjenjuje u kombinaciji s lopinavirom/ritonavirom, doza lijeka Vitekta mora biti 85 mg jedanput na dan.
English: When used in combination with fosamprenavir, the dose of Vitekta should be 150 mg once daily.
Croatian: Kada se primjenjuje u kombinaciji s fosamprenavirom, doza lijeka Vitekta mora biti 150 mg jedanput na dan.
English: • atazanavir and ritonavir
Croatian: • atazanavir i ritonavir
English: There are no data available to make dosing recommendations for co-administration with other doses of atazanavir (see section 4.2).
Croatian: Ne postoje dostupni podaci o preporukama doziranja za istovremenu primjenu s drugim dozama atazanavira (vidjeti dio 4.2).
English: Refer to the package leaflet for Vitekta 85 mg tablets.
Croatian: Pročitajte Sažetak opisa svojstava lijeka za Vitekta 85 mg tablete.
English: Ketoconazole (200 mg twice daily) Elvitegravir (150 mg once daily) Ritonavir (100 mg once daily)
Croatian: Ketokonazol (200 mg dvaput na Elvitegravir (150 mg jedanput na Ritonavir (100 mg jedanput na dan)
English: Each film-coated tablet contains 85 mg elvitegravir.
Croatian: Jedna filmom obložena tableta sadrži 85 mg elvitegravira.
English: No dose adjustment is required when Vitekta is co-administered with famotidine.
Croatian: Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s famotidinom.
English: MARKETING AUTHORISATION HOLDER
Croatian: Sažetak profila sigurnosti primjene
English: • fosamprenavir and ritonavir
Croatian: • fosamprenavir i ritonavir
English: No dose adjustment is required when Vitekta is co-administered with etravirine.
Croatian: Prilagodba doze nije potrebna kada se Vitekta istovremeno primjenjuje s etravirinom.