FrancophonIA/ELRC3.0 huggingface dataset:
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Croatian: U pacijenata inficiranih HIV-om s teškom imunodeficijencijom u vrijeme početka CART-a može nastati upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
English: High density polyethylene (HDPE) bottle with a child-resistant closure containing 30 film-coated
Croatian: Boca od polietilena visoke gustoće (HDPE) sa sigurnosnim zatvaračem za djecu, koja sadrži 30 filmom obloženih tableta.
English: Adverse reactions to elvitegravir from clinical study experience are listed in Table 3 below, by body system organ class and frequency.
Croatian: Nuspojave na elvitegravir iz iskustva iz kliničkog ispitivanja navedene su niže u tablici 3 po organskim sustavima i učestalosti.
English: Co-administration of Vitekta and rifabutin is not recommended.
Croatian: Ne preporučuje se istovremena primjena lijeka Vitekta i rifabutina.
English: Elvitegravir is primarily metabolised by CYP3A.
Croatian: Elvitegravir se prvenstveno metabolizira putem CYP3A.
English: Virologic response was defined as achieving an undetectable viral load (HIV-1 RNA < 50 copies/mL).
Croatian: Virološki je odgovor definiran kao nemjerljivo virusno opterećenje (HIV-1 RNK < 50 kopija/ml).
English: In addition, in vitro studies have shown that elvitegravir is a weak to modest inducer of CYP1A2, CYP2C19 and CYP3A enzymes.
Croatian: Uz to su in vitro ispitivanja pokazala da je elvitegravir slab do umjeren induktor enzima CYP1A2, CYP2C19 i CYP3A.
English: In study GS-US-183-0145, diarrhoea was reported as an adverse reaction in 7.1% of subjects in the elvitegravir group and in 5.3% of subjects in the raltegravir group.
Croatian: U ispitivanju GS-US-183-0145 proljev je zabilježen kao nuspojava u 7,1% ispitanika u skupini na elvitegraviru i u 5,3% ispitanika u skupini na raltegraviru.
English: No dose adjustment of Vitekta is required for patients with renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze lijeka Vitekta za pacijente s oštećenjem bubrega (vidjeti dio 5.2).
English: Ritonavir inhibits CYP3A, thereby substantially increasing the plasma concentrations of elvitegravir.
Croatian: Ritonavir inhibira CYP3A, značajno povećavajući koncentracije elvitegravira u plazmi.
English: Interaction not studied with elvitegravir.
Croatian: Interakcija nije ispitana s elvitegravirom.
English: Relative to fasting conditions, the administration of boosted elvitegravir as the fixed-dose combination 150 mg elvitegravir/150 mg cobicistat/200 mg emtricitabine/245 mg tenofovir disoproxil with a light meal (approximately 373 kcal, 20% fat) or high-fat meal (approximately 800 kcal, 50% fat) resulted in increased exposures of elvitegravir.
Croatian: U odnosu na natašte, primjena pojačanog elvitegravira kao kombinacije fiksne doze od 150 mg elvitegravira/150 mg kobicistata/200 mg emtricitabina/245 mg tenofovirdizoproksil s laganim obrokom (približno 373 kcal, 20% masnoće) ili punomasnim obrokom (približno 800 kcal, 50% masnoće) rezultirala je povećanom izloženošću elvitegravira.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE
English: The pharmacokinetics of elvitegravir in paediatric subjects have not been established.
Croatian: Farmakokinetika elvitegravira u pedijatrijskih ispitanika nije utvrđena.
English: Sex a Genotypic sensitivity scores are calculated by summing up drug susceptibility values (1 = sensitive; 0 = reduced susceptibility) on all drugs in the baseline background regimen.
Croatian: Rezultat početne genotipske osjetljivosti a a Rezultati genotipske osjetljivosti izračunati su zbrajanjem vrijednosti osjetljivosti lijeku (1 = osjetljivost; 0 = smanjena osjetljivost) za sve lijekove u početnom pozadinskom režimu.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: If the patient vomits within 1 hour of taking Vitekta another tablet should be taken.
Croatian: Ako pacijent povraća unutar 1 sata od uzimanja lijeka Vitekta, mora uzeti drugu tabletu.
English: There are no data to recommend the use of Vitekta with dosing frequencies or HIV-1 protease inhibitors other than those presented in Table 1.
Croatian: Ne postoje nikakvi drugi podaci o preporuci primjene lijeka Vitekta s učestalošću doziranja ili inhibitorima proteaze HIV-1 osim onih navedenih u tablici 1.
English: Animal studies do not indicate direct or indirect harmful effects of elvitegravir with respect to reproductive toxicity.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak elvitegravira na reprodukciju.
English: It is recommended to separate Vitekta and antacid administration by at least 4 hours.
Croatian: Preporučuje se primjenu lijeka Vitekta razdvojiti od primjene antacida za najmanje 4 sata.
English: The efficacy of elvitegravir is primarily based on the analyses through 96 weeks from one randomised, double-blind, active-controlled study, study GS-US-183-0145, in treatment-experienced, HIV-1 infected patients (n = 702).
Croatian: Djelotvornost elvitegravira primarno se temelji na analizama kroz 96 tjedana jednog randomiziranog, dvostruko slijepog, aktivnim lijekom kontroliranog ispitivanja, GS-US-183-0145, u već liječenih pacijenata zaraženih virusom HIV-1 (n = 702).
English: For example, atazanavir/ritonavir and lopinavir/ritonavir (potent UGT1A1/3 inhibitors) have been shown to significantly increase the plasma concentrations of elvitegravir (see Table 2).
Croatian: Primjerice, pokazalo se da atazanavir/ritonavir i lopinavir/ritonavir (potentni inhibitori UGT1A1/3) značajno povećavaju koncentracije elvitegravira u plazmi (vidjeti tablicu 2).
English: Uncommon suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness), depression, insomnia
Croatian: suicidalne ideje i pokušaj suicida (u pacijenata s već postojećom depresijom ili psihijatrijskom bolešću u anamnezi), depresija, nesanica Poremećaji živčanog sustava: Često:
English: Co-administration of Vitekta with strong CYP3A inducers (including St. John's wort [Hypericum perforatum], rifampicin, carbamazepine, phenobarbital and phenytoin) is contraindicated (see sections 4.3 and 4.5).
Croatian: Kontraindicirana je istovremena primjena lijeka Vitekta i jakih induktora CYP3A (uključujući gospinu travu [Hypericum perforatum], rifampicin, karbamazepin, fenobarbital i fenitoin) (vidjeti dijelove 4.3 i 4.5).
English: Animal studies do not indicate harmful effects of elvitegravir on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke elvitegravira na plodnost.
English: Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir (see
Croatian: Vitekta je indicirana, istovremeno primijenjena s ritonavirom pojačanim inhibitorom proteaze i s drugim antiretrovirusnim lijekovima, za liječenje infekcije virusom humane imunodeficijencije-1 (HIV-1) u odraslih koji su zaraženi virusom HIV-1 bez poznatih mutacija povezanih s rezistencijom na elvitegravir (vidjeti dijelove 4.2 i 5.1).
English: Elvitegravir has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.4 and 5.2).
Croatian: Elvitegravir nije ispitan u pacijenata s teškim oštećenjem jetre (Child-Pugh stadij C) (vidjeti dijelove 4.4 i 5.2).
English: BOTTLE AND CARTON LABELLING
Croatian: OZNAČAVANJE NA BOCI I KUTIJI
English: Therefore, Vitekta should not be used during breastfeeding.
Croatian: Stoga se Vitekta ne bi trebala primjenjivati tijekom dojenja.
English: Vitekta contains the active substance elvitegravir.
Croatian: Vitekta sadrži djelatnu tvar elvitegravir.
English: Elvitegravir plasma exposures are non-linear and less than dose-proportional, likely due to solubility
Croatian: Izloženosti elvitegraviru u plazmi su nelinearne i manje od onih proporcionalnih dozi, vjerojatno zbog apsorpcije ograničene topljivošću.
English: Elvitegravir is primarily metabolised by CYP3A (see section 5.2).
Croatian: Elvitegravir se prvenstveno metabolizira putem CYP3A (vidjeti dio 5.2).
English: Virologic success rates at week 96 for elvitegravir and raltegravir were 39.0% (23/59) and 52.2% (35/67) (difference: -8.4% [95% CI: -26.1% to 9.2%]), respectively, for female subjects, and 55.1% (161/292) and 53.2% (151/284) (difference: 1.5% [95% CI: -6.5% to 9.6%]), respectively, for male subjects.
Croatian: Stope virološkog uspjeha u 96. tjednu za elvitegravir i raltegravir bile su 39,0% (23/59), odnosno 52,2% (35/67) (razlika: -8,4% [95% CI: -26,1% do 9,2%]) za ispitanice, a za ispitanike 55,1% (161/292), odnosno 53,2% (151/284) (razlika: 1,5% [95% CI: -6,5% do 9,6%]).
English: In these subjects, diarrhoea was mild to moderate in severity and did not result in discontinuation of study drug.
Croatian: U tih je ispitanika proljev bio blag do umjeren i nije rezultirao prekidom liječenja ispitivanim lijekom.
English: Limited data from population pharmacokinetic analysis (n = 56) indicated that hepatitis B and/or C virus infection had no clinically relevant effect on the exposure of boosted elvitegravir.
Croatian: Istovremena infekcija virusom hepatitisa B i/ili hepatitisa C Ograničeni podaci iz populacijske farmakokinetičke analize (n = 56) pokazali su da istovremena infekcija virusom hepatitisa B i/ili C nema klinički značajan učinak na izloženost pojačanom
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint
Croatian: Pacijente treba uputiti da se obrate liječniku ako osjete bolove u zglobovima, ukočenost zglobova ili teškoće pri
English: In study GS-US-183-0145, patients were randomised in a 1:1 ratio to receive either elvitegravir (150 mg or 85 mg) once daily or raltegravir 400 mg twice daily, each administered with a background regimen (BR) containing a fully-active ritonavir-boosted protease inhibitor (either atazanavir, darunavir, fosamprenavir, lopinavir or tipranavir) and a second agent.
Croatian: U ispitivanju GS-US-183-0145 pacijenti su randomizirani u omjeru 1:1 na primanje elvitegravira (150 mg ili 85 mg) jedanput na dan ili raltegravira 400 mg dvaput na dan, svaka je primjena bila uz pozadinski režim (BR) koji se sastojao od potpuno aktivnog, ritonavirom pojačanog inhibitora proteaze (atazanavir, darunavir, fosamprenavir, lopinavir ili tipranavir) i drugi lijek.
English: Due to the need for co-administration of Vitekta with a ritonavir-boosted protease inhibitor, prescribers should consult the Summary of Product Characteristics of the co-administered protease inhibitor and ritonavir for a description of contraindicated medicinal products and other significant drug-drug interactions that may cause potentially life-threatening adverse reactions or loss of therapeutic effect and possible development of resistance.
Croatian: Zbog potrebe za istovremenomprimjenom lijeka Vitekta i ritonavirom pojačanog inhibitora proteaze, liječnici trebaju pročitati Sažetak opisa svojstava istovremeno primijenjenog inhibitora proteaze i ritonavira radi opisa kontraindiciranih lijekova i drugih značajnih interakcija lijekova koji mogu uzrokovati moguće smrtonosne nuspojave ili gubitak terapijskog učinka i mogućeg razvoja
English: There are no or limited clinical data with elvitegravir in pregnant women.
Croatian: Nema podataka ili su klinički podaci o elvitegraviru u trudnica ograničeni.
English: • St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it
Croatian: • gospina trava (Hypericum perforatum), biljni pripravak koji se primjenjuje za depresiju i tjeskobu, ili proizvodi koji sadrže gospinu travu
English: Administration of once-daily ritonavir (20-200 mg) results in an increased elvitegravir exposure following repeat once-daily administration, with elvitegravir exposure reaching a plateau with approximately 100 mg of ritonavir.
Croatian: Primjena ritonavira jedanput na dan (20-200 mg) rezultira povećanom izloženošću elvitegraviru nakon ponovljene primjene doze jedanput na dan, pri čemu izloženost elvitegraviru postiže plato s približno 100 mg ritonavira.
English: Boosting elvitegravir with an agent other than ritonavir may result in suboptimal plasma concentrations of elvitegravir and/or the protease inhibitor leading to loss of therapeutic effect and possible development
Croatian: Pojačavajući elvitegravir lijekom koji nije ritonavir može rezultirati suboptimalnim koncentracijama elvitegravira i/ili inhibitora proteaze u plazmi, što može dovesti do gubitka terapijskog učinka i mogućeg razvoja rezistencije.
English: Antimycobacterials Rifabutin (150 mg once every other day)
Croatian: Antimikobakterijski lijekovi Rifabutin (150 mg jedanput svaki drugi dan)
English: The prescriber should always refer to the Summary of Product Characteristics for ritonavir, or the protease inhibitor.
Croatian: Liječnik uvijek treba pročitati Sažetak opisa svojstava ritonavira, odnosno inhibitora proteaze.
English: Take the 85 mg tablet at the same time as atazanavir and ritonavir, or at the same time as the first dose of lopinavir/ritonavir.
Croatian: Tabletu od 85 mg uzmite u isto vrijeme kad uzmete i atazanavir i ritonavir ili u isto vrijeme kad uzmete prvu dozu lopinavira/ritonavira.
English: Assessment of adverse reactions is based on data from a controlled clinical study (GS-US-183-0145) in which 712 HIV-1 infected, antiretroviral treatment-experienced adults received elvitegravir (n = 354) or raltegravir (n = 358) each administered with a background regimen consisting of a fully active ritonavir-boosted protease inhibitor and other antiretroviral agents.
Croatian: Procjena nuspojava temelji se na podacima iz kontroliranog kliničkog ispitivanja (GS-US-183-0145) u kojem su 712 odraslih zaraženih virusom HIV-1 koji su već liječeni antiretrovirusnom terapijom, primali elvitegravir (n = 354) ili raltegravir (n = 358), čije su primjene bile uz pozadinski režim koji se sastojao od potpuno aktivnog, ritonavirom pojačanog inhibitora proteaze i drugih antiretrovirusnih lijekova.
English: Co-administration of Vitekta with medicinal products that are potent inhibitors of UGT1A1/3 may result in increased elvitegravir plasma concentrations and dose modifications may be required.
Croatian: Istovremena primjena lijeka Vitekta s lijekovima koji su potentni inhibitori UGT1A1/3 može rezultirati povećanim koncentracijama elvitegravira u plazmi te mogu biti potrebne prilagodbe doza.
English: A study of the pharmacokinetics of boosted elvitegravir was performed in non HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 mL/min).
Croatian: Ispitivanje farmakokinetike pojačanog elvitegravira provedeno je na ispitanicima koji nisu zaraženi s HIV-1, a koji imaju teško oštećenje funkcije bubrega (procijenjeni klirens kreatinina ispod 30 ml/min).
English: Table 4: Demographic and baseline disease characteristics of antiretroviral treatmentexperienced HIV-1 infected adult subjects in study GS-US-183-0145
Croatian: Tablica 4: Demografske značajke i početne značajke bolesti u odraslih već liječenih ispitanika zaraženih virusom HIV-1 antiretrovirusnim lijekovima, u ispitivanju GS-US-183-0145
English: Female patients of childbearing potential should use either a hormonal contraceptive containing at least 30 µg ethinylestradiol and containing norgestimate as the progestagen or should use an alternative reliable method of contraception (see sections 4.5 and 4.6).
Croatian: Pacijentice reproduktivne dobi moraju primjenjivati hormonsku kontracepciju koja sadrži najmanje 30 µg etinilestradiola i norgestimat kao progestagen ili moraju primjenjivati drugu pouzdanu metodu kontracepcije (vidjeti dijelove 4.5 i 4.6).
English: The in vitro antiviral activity of elvitegravir when combined with antiretroviral drugs from the nucleos(t)ide reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), integrase strand transfer inhibitor, fusion inhibitor, or CCR5 co-receptor antagonist classes showed no
Croatian: Antivirusna aktivnost in vitro elvitegravira u kombinaciji s antiretrovirusnim lijekovima iz skupine nukleozidnih/nukleotidnih inhibitora reverzne transkriptaze (NRTI), nenukleozidnih inhibitora reverzne transkriptaze (NNRTI), inhibitora proteaze (PI), inhibitora prijenosa lanca integraze, fuzijskih inhibitora ili antagonista CCR5-koreceptora, nije pokazala antagonizam.
English: Marketing Authorisation Holder Gilead Sciences International Limited Cambridge
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Gilead Sciences International Limited Cambridge
English: • If you notice within 18 hours of the time you usually take Vitekta, you must take the tablet as soon as possible.
Croatian: • Ako to primijetite a prošlo je manje 18 sati od vremena kad obično uzimate lijek Vitekta, tabletu morate uzeti što prije.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
English: Co-administration of Vitekta with medicinal products that are moderate inducers of CYP3A (including, but not limited to, efavirenz and bosentan) is not recommended 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 4.4).
Croatian: Istovremena primjena lijeka Vitekta s lijekovima koji su umjereni induktori CYP3A (uključujući, bez ograničenja, efavirenz i bosentan) ne preporučuje se jer očekivano smanjenje koncentracija elvitegravira u plazmi može dovesti do gubitka terapijskog učinka i mogućeg razvoja rezistencije na elvitegravir (vidjeti dio 4.4).
English: Take the 150 mg tablet at the same time as the first dose of darunavir or fosamprenavir and ritonavir.
Croatian: Tabletu od 150 mg uzmite u isto vrijeme kad uzimate prvu dozu darunavira ili fosamprenavira i ritonavira.
English: Patients with HIV and hepatitis B or C virus co-infection Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Croatian: Pacijenti s istovremenom infekcijom HIV-om i infekcijom virusom hepatitisa B ili C Pacijenti s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom, izloženi su povećanom riziku od teških i potencijalno smrtonosnih jetrenih nuspojava.
English: In study GS-US-183-0145, subgroup analyses by co-administered protease inhibitor showed similar rates of virologic success for elvitegravir and raltegravir within each protease inhibitor subgroup at weeks 48 and 96 (HIV-1 RNA < 50 copies/mL) (Table 6).
Croatian: U ispitivanju GS-US-183-0145 analize podskupina putem istovremeno primijenjenog inhibitora proteaze pokazale su slične stope virološkog uspjeha za elvitegravir i raltegravir unutar svake podskupine inhibitora proteaze u 48. i 96. tjednu (HIV-1 RNK < 50 kopija/ml) (tablica 6).
English: Vitekta must be administered in combination with a ritonavir-boosted protease inhibitor.
Croatian: Vitekta se mora primjenjivati u kombinaciji s ritonavirom pojačanim inhibitorom proteaze.
English: ↑ Ketoconazole§
Croatian: I DOHVATA
English: 105/202 (52.0%) 112/207 (54.1%) -2.1% (-11.8% to 7.5%) -1.5% (-18.2% to 15.3%)
Croatian: 105/202 (52,0%) 112/207 (54,1%) -2,1% (-11,8% do 7,5%) -1,5% (-18,2% do 15,3%)
English: The active substance is elvitegravir.
Croatian: Djelatna tvar je elvitegravir.
English: The hormonal contraceptive should contain at least 30 µg ethinylestradiol and contain norgestimate as the progestagen or patients should use an alternative reliable method of contraception (see sections 4.4 and 4.6).
Croatian: Hormonski kontraceptiv mora sadržavati najmanje 30 µg etinilestradiola i sadržavati norgestimat kao progestagen ili pacijentice moraju primjenjivati drugu pouzdanu metodu kontracepcije (vidjeti dijelove 4.4 i
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for boosted
Croatian: Klinički značajne farmakokinetičke razlike vezane uz etničku pripadnost nisu ustanovljene za pojačani
English: If the patient misses a dose of Vitekta within 18 hours of the time it is usually taken, the patient should take Vitekta with food as soon as possible and resume the normal dosing schedule.
Croatian: Ako pacijent propusti uzeti dozu lijeka Vitekta, a prošlo je manje 18 sati od uobičajenog vremena uzimanja doze, pacijent mora što prije uzeti lijek Vitekta s hranom i potom ga nastaviti uzimati prema uobičajenom rasporedu.
English: When used in combination with Vitekta, the recommended dose of atazanavir is 300 mg with ritonavir 100 mg once daily.
Croatian: Kada se primjenjuje u kombinaciji s lijekom Vitekta, preporučena doza atazanavira je 300 mg s ritonavirom 100 mg jedanput na dan.
English: No human data on the effect of elvitegravir on fertility are available.
Croatian: Nema dostupnih podataka o utjecaju elvitegravira na plodnost u ljudi.
English: Therefore, whenever possible, Vitekta should be administered with a fully active ritonavir-boosted protease inhibitor and a second fully active antiretroviral agent to minimise the potential for virologic failure and the development of
Croatian: Stoga je, kad god je moguće, lijek Vitekta potrebno primijeniti s potpuno aktivnim, ritonavirom pojačanim, inhibitorom proteaze i drugim potpuno aktivnim antiretrovirusnim lijekom kako bi se umanjila mogućnost virološkog neuspjeha i razvoja rezistencije (vidjeti dio 5.1).
English: Elvitegravir has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Elvitegravir nije ispitivan u pacijenata s teškim oštećenjem jetre (Child-Pugh stadij C).
English: 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).
Croatian: 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).
English: No dose adjustment of Vitekta is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B).
Croatian: Nije potrebna prilagodba doze lijeka Vitekta u pacijenata s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem jetre.
English: 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.
Croatian: 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.
English: Table 3: Tabulated summary of adverse reactions to elvitegravir based on experience for 96 weeks from clinical study GS-US-183-0145
Croatian: Tablica 3: Tablični sažetak nuspojava na elvitegravir na temelju iskustava u trajanju od 96 tjedana iz kliničkog ispitivanja GS-US-183-0145
English: Lopinavir/Ritonavir (400/100 mg twice daily)
Croatian: Lopinavir/ritonavir (400/100 mg dvaput na dan)