FrancophonIA/ELRC3.0 huggingface dataset:
English: Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 2,396 patients received emtricitabine + tenofovir alafenamide given with elvitegravir + cobicistat as a fixed-dose combination tablet, pooled data from 686 patients who received rilpivirine 25 mg once daily in combination with other antiretroviral medicinal products in the controlled studies TMC278-C209 and TMC278-C215, 754 patients who received Odefsey in Studies GS-US-366-1216 and GS-US-366-1160, and post-marketing experience.
Croatian: + tenofoviralafenamid davanim s elvitegravirom + kobicistatom u obliku tablete s fiksnom kombinacijom doza, objedinjenim podacima 686 bolesnika koji su u kontroliranim ispitivanjima TMC278-C209 i TMC278-C215 primali 25 mg rilpivirina jedanput na dan u kombinaciji s drugim antiretrovirusnim lijekovima, 754 bolesnika koji su primali Odefsey u ispitivanjima GS-US-366-1216 i GS-US-366-1160 i iz razdoblja nakon stavljanja u promet.
English: How to store Odefsey
Croatian: Kako čuvati lijek Odefsey
English: At Week 48, 81.8% (45/55 patients) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF.
Croatian: U 48. tjednu, HIV-1 RNK < 50 kopija/ml zadržala se u 81,8% (45/55 bolesnika) nakon prebacivanja na E/C/F/TAF.
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Croatian: Deksametazon (sistemska primjena, osim za primjenu jednokratne doze)
English: In Study GS-US-366-1216, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 16 cells/mm3 in those who remained on FTC/RPV/TDF.
Croatian: Ispitivanju GS-US-366-1216, srednja vrijednost promjene u odnosu na početni broj stanica CD4+ u 96. tjednu bila je 12 stanica/mm3 u bolesnika koji su prebačeni na Odefsey i 16 stanica/mm3 u onih koji su ostali na FTC/RPV/TDF.
English: In Study GS-US-366-1160, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 6 cells/mm3 in those who stayed on EFV/FTC/TDF.
Croatian: U Ispitivanju GS-US-366-1160, srednja vrijednost promjene u odnosu na početni broj stanica CD4+ u 96. tjednu bila je 12 stanice/mm3 u bolesnika koji su prebačeni na Odefsey i 6 stanica/mm3 u onih koji su ostali na EFV/FTC/TDF.
English: The pharmacokinetics of rilpivirine in paediatric patients < 12 years of age is under investigation.
Croatian: Farmakokinetika rilpivirina u pedijatrijskih bolesnika u dobi
English: Median plasma HIV-1 RNA was 5.0 log10 copies/mL and median CD4+ cell count was 255 cells/mm3.
Croatian: Medijan HIV-1 RNK u plazmi bio je 5,0 log10 kopija/ml, medijan broja CD4+ stanica bio je 255 stanica/mm3.
English: Resistance testing and/or historical resistance data should guide the use of Odefsey (see section 5.1).
Croatian: Liječenje lijekom Odefsey treba se voditi na temelju ispitivanja rezistencije i/ili podataka o rezistenciji iz povijesti bolesti (vidjeti dio 5.1).
English: In a study of virologically suppressed patients switching from EFV/FTC/TDF to Odefsey (Study GS-US-366-1160), decreases from baseline were observed in the fasting values of total cholesterol and HDL-cholesterol in the Odefsey arm; no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio, direct LDL-cholesterol or triglycerides were observed in either treatment arm at Week 96.
Croatian: U ispitivanju s virološki suprimiranim bolesnicima koji su prebačeni s EFV/FTC/TDF na Odefsey (Ispitivanje GS-US-366-1160), u skupini koja je primala Odefsey opažena su smanjenja u odnosu na početnu vrijednost u vrijednostima ukupnog kolesterola i HDL kolesterola natašte; nikakve klinički relevantne promjene u odnosu na početne vrijednosti nisu opažene za medijan vrijednosti omjera ukupnog kolesterola i HDL kolesterola, direktnog LDL kolesterola ili triglicerida natašte ni u jednoj liječenoj skupini u 96. tjednu.
English: If you vomit less than 4 hours after taking Odefsey, take another tablet with food.
Croatian: Ako povratite unutar 4 sata od uzimanja lijeka Odefsey, uzmite drugu tabletu s hranom.
English: Co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Croatian: Istodobna primjena može prouzročiti značajna smanjenja koncentracije rilpivirina u plazmi (smanjena apsorpcija, povećanje zelučanih pH-vrijednosti).
English: If the patient vomits within 4 hours of taking Odefsey another tablet should be taken with food.
Croatian: Ako bolesnik povrati unutar 4 sata od uzimanja lijeka Odefsey, mora uzeti drugu tabletu s hranom.
English: In Study GS-US-292-1825, the efficacy and safety of E/C/F/TAF were evaluated in a single arm, open-label clinical study in which 55 HIV-1 infected adults with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis for at least 6 months before switching to E/C/F/TAF FDC tablet.
Croatian: U otvorenom kliničkom ispitivanju GS-US-292-1825, djelotvornost i sigurnost E/C/F/TAF procijenjene su u jednoj skupini od 55 odraslih osoba zaraženih virusom HIV-1 sa završnim stadijem bolesti bubrega (eGFRCG < 15 ml/min) i na kroničnoj hemodijalizi tijekom najmanje 6 mjeseci prije prebacivanja na E/C/F/TAF tablete.
English: If you are taking an H2-antagonist, take it at least 12 hours before or at least 4 hours after Odefsey.
Croatian: Ako uzimate H2-antagonist, uzmite ga najmanje 12 sata prije ili najmanje 4 sata nakon uzimanja lijeka Odefsey.
English: What you need to know before you take Odefsey Do not take Odefsey:
Croatian: Što morate znati prije nego počnete uzimati lijek Odefsey
English: The combination of Odefsey with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Croatian: Kombinacija lijeka Odefsey s ovim makrolidnim antibioticima može uzrokovati povećanje koncentracije rilpivirina (inhibicija CYP3A) i tenofoviralafenamida (inhibicija P-gp) u plazmi.
English: The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells,
Croatian: Antivirusna aktivnost tenofoviralafenamida na laboratorijske i kliničke izolate virusa HIV-1 podtipa B procijenjena je na limfoblastoidnim staničnim linijama, PBMC-ovima, primarnim monocitnim/makrofagnim stanicama i CD4+ T-limfocitima.
English: AUC: ↓ 5% Cmin: ↓ 7% Cmax: ↓ 3%
Croatian: AUC: ↓ 5% Cmax: ↓ 7% Cmax: ↓ 3%
English: In a study of virologically suppressed patients switching from FTC/RPV/TDF to Odefsey (Study GS-US-366-1216), increases from baseline were observed in fasting values of total cholesterol, direct LDL-cholesterol, HDL-cholesterol, and triglycerides in the Odefsey arm; and no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio were observed in either treatment arm at Week 96.
Croatian: U ispitivanju s virološki suprimiranim bolesnicima koji su prebačeni s FTC/RPV/TDF na Odefsey (Ispitivanje GS-US-366-1216), u skupini koja je primala Odefsey opažena su povećanja u odnosu na početnu vrijednost u vrijednostima ukupnog kolesterola, direktnog LDL kolesterola, HDL kolesterola i triglicerida natašte; nikakve klinički relevantne promjene u odnosu na početne vrijednosti nisu opažene za medijan vrijednosti omjera ukupnog kolesterola i HDL kolesterola natašte ni u jednoj liječenoj skupini u 96. tjednu.
English: Rifampicin:
Croatian: Rilpivirin:
English: The mean baseline CD4+ cell count was 709 cells/mm3 (range 104-2,527).
Croatian: Srednja vrijednost početnog broja CD4+ stanica iznosila je 709 stanica/mm3 (raspon 104−2527).
English: 25-O-desacetyl-rifabutin:
Croatian: 25-O-desacetilrifabutin: AUC: ↔
English: Ketoconazole (400 mg once daily)/ Rilpivirine1
Croatian: Ketokonazol (400 mg jedanput na dan)/rilpivirin1
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 4.8).
Croatian: Nije bilo utvrđenih novih sigurnosnih pitanja u bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi koji su primali fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti (vidjeti dio 4.8).
English: omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acid reflux disease) dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
Croatian: - karbamazepin, okskarbazepin, fenobarbital i fenitoin (koriste se u liječenju epilepsije i za sprječavanje napada) - rifabutin, rifampicin i rifapentin (koriste se za liječenje nekih bakterijskih infekcija, kao što je tuberkuloza) - omeprazol, dekslanzoprazol, lanzoprazol, rabeprazol, pantoprazol i esomeprazol (koriste se za sprječavanje i liječenje čireva želuca i dvanaesnika, žgaravice, gastroezofagealne refluksne bolesti) - deksametazon (kortikosteroidni lijek koji se koristi za liječenje upala i suprimiranje imunološkog sustava) kada se uzima na usta ili se ubrizgava (osim kod liječenja primjenom jednokratne doze) - proizvodi koji sadržavaju gospinu travu (Hypericum perforatum) (biljni lijek koji se primjenjuje za depresiju i tjeskobu)
English: Co-administration of ketoconazole is expected to increase plasma concentrations of tenofovir alafenamide (inhibition of P-gp).
Croatian: Očekuje se da će istodobna primjena ketokonazola povisiti koncentracije tenofoviralafenamida (inhibicija P-gp) u plazmi.
English: Interaction not studied with any of the components of Odefsey.
Croatian: Interakcija nije ispitana ni s jednom komponentom lijeka
English: headache1, 3, dizziness1, 3
Croatian: glavobolja1,3, omaglica1,3
English: 4 Adverse reaction identified through post-marketing surveillance of emtricitabine/rilpivirine/tenofovir disoproxil fumarate.
Croatian: 4 Nuspojava prepoznata tijekom praćenja lijeka emtricitabin/rilpivirin/tenofovirdizoproksilfumarat nakon stavljanja u promet.
English: Odefsey [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Odefsey [samo vanjsko pakiranje]
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Rilpivirine2
Croatian: Sofosbuvir/velpatasvir (400 mg/100 mg jedanput na dan)/rilpivirin2
English: Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet (E/C/F/TAF) in Study GS-US-292-1825 were significantly higher than in patients with normal renal function.
Croatian: CrCl < 15 ml/min) na kroničnoj hemodijalizi koji su primali emtricitabin + tenofoviralafenamid s elvitegravirom + kobicistatom u fiksnoj kombinaciji u tableti (E/C/F/TAF) u ispitivanju GS-US-292-1825 bila je značajno veća nego u bolesnika s normalnom funkcijom bubrega.
English: (n = 438)
Croatian: ODE (n = 438)
English: 0% (95% CI: -4.8% to 4.8%)
Croatian: 0% (95% CI: -4,8% do 4,8%)
English: AUC: ↔ Cmin: ↓ 15% Cmax: ↑ 35%
Croatian: Atorvastatin AUC: ↔ Cmin: ↓ 15% Cmax: ↑ 35%
English: The median baseline plasma HIV-1 RNA was 4.8 log10 copies/mL, and the median baseline CD4+ cell count was 414 cells/mm3.
Croatian: Medijan početne vrijednost HIV-1 RNK u plazmi bio je 4,8 log10 kopija/ml, medijan početnog broja CD4+ stanica bio je 414 stanica/mm3.
English: Each film-coated tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Croatian: Jedna filmom obložena tableta sadržava 200 mg emtricitabina, rilpivirinklorid što odgovara 25 mg rilpivirina i tenofoviralafenamidfumarat što odgovara 25 mg tenofoviralafenamida.
English: The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813).
Croatian: Srednja vrijednost početnog broja CD4+ stanica iznosila je 664 stanica/mm3 (raspon: 126-1813).
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 5.2).
Croatian: Nije bilo utvrđenih novih sigurnosnih pitanja u bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi koji su primali fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti (vidjeti dio 5.2).
English: The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Croatian: Tenofoviralafenamid je pokazao antivirusnu aktivnost u staničnoj kulturi protiv svih skupina virusa HIV-1 (M, N i O), uključujući podtipove A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,10 do 12,0 nM) i aktivnost na sojeve HIV-2 (vrijednosti EC50 bile su u rasponu od 0,91 do 2,63 nM).
English: Each Odefsey tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Croatian: Jedna Odefsey tableta sadrži 200 mg emtricitabina, rilpivirinklorid što odgovara 25 mg rilpivirina i tenofoviralafenamidfumarat što odgovara 25 mg tenofoviralafenamida.
English: In studies in treatment-naïve patients receiving emtricitabine + tenofovir alafenamide (FTC + TAF) or emtricitabine + tenofovir disoproxil fumarate (FTC + TDF), both given with elvitegravir + cobicistat as a fixed-dose combination tablet, increases from baseline were observed in both treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
Croatian: (FTC + TDF), pri čemu su oba lijeka davana s elvitegravirom + kobicistatom u obliku tablete s fiksnom kombinacijom, u obje liječene skupine uočio porast u odnosu na početne vrijednosti lipida natašte, i to za ukupni kolesterol, lipoproteine niske gustoće (LDL) i lipoproteine visoke gustoće (HDL) te trigliceride, u 144. tjednu.
English: FTC/RPV /TDF
Croatian: RPV + FTC/TDF
English: Cortisol
Croatian: Kortizol
English: Rifabutin (300 mg once daily)/ Rilpivirine1
Croatian: Rifabutin (300 mg jedanput na dan)/rilpivirin1
English: c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis).
Croatian: a n = 24 adolescenta (GS-US-292-0106); n = 19 odraslih (GS-US-292-0102) b n = 23 adolescenta (GS-US-292-0106, populacijska farmakokinetička analiza) c n = 539 (TAF) ili 841 (TFV) odraslih (GS-US-292-0111 i GS-US-292-0104, populacijska farmakokinetička analiza)
English: Nervous system disorders Very common:
Croatian: Poremećaji živčanog sustava
English: The mean baseline CD4+ cell count was 700 cells/mm3 (range 140-1,862).
Croatian: Srednja vrijednost početnog broja CD4+ stanica iznosila je 700 stanica/mm3 (raspon 140−1862).
English: tenofovir alafenamide tenofovir disoproxil lamivudine adefovir dipivoxil
Croatian: tenofoviralafenamid tenofovirdizoproksil lamivudin adefovirdipivoksil
English: Patients had a mean age of 45 years (range 23-72), 90% were male, 75% were White, and 19% were Black.
Croatian: Srednja vrijednost dobi bolesnika bila je 45 godina (raspon 23−72), 90% su bili muškarci, 75% bijelci i 19% crnci.
English: 6 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Croatian: 6 Nuspojava prepoznata tijekom praćenja lijekova koji sadrže tenofoviralafenamid nakon njihova stavljanja u promet.
English: 0.7% (95% CI: -4.3% to 5.8%)
Croatian: 0,7% (95% CI: -4,3% do 5,8%)
English: ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Croatian: Karbamazepin Okskarbazepin Fenobarbital
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Croatian: Sigurnost emtricitabina + tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog Ispitivanja (GS-US-292-0106) u kojem je 50 pedijatrijskih bolesnika u dobi od 12 do < 18 godina zaraženih virusom HIV-1 koji prethodno nisu bili liječeni, primalo emtricitabin + tenofoviralafenamid u kombinaciji s elvitegravirom i kobicistatom u obliku tablete s fiksnom kombinacijom.
English: Paracetamol: AUC: ↔ Cmin: N/A
Croatian: Paracetamol: AUC: ↔ Cmin: N/P Cmax: ↔
English: Patients had a mean age of 48 years (range 19-76), 87% were male, 67% were White, and 27% were Black.
Croatian: Srednja vrijednosti dobi bolesnika bila je 48 godina (raspon 19−76), 87% su bili muškarci, 67% bijelci i 27% crnci.
English: 2.0% (95% CI: -0.7% to 4.7%) 4.2% (95% CI: 0.6% to 7.8%) 4.1% (95% CI: 1.6% to 6.7%, p < 0.001c)
Croatian: 4,1% (95% CI: 1,6% do 6,7%; p < 0,001c)
English: had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load > 100,000 copies/mL (30/262).
Croatian: Tijekom 96. tjedna je manje bolesnika u skupini koja uzima rilpivirin s početnim virusnim opterećenjem ≤ 100 000 kopija/ml imalo novonastale supstitucije povezane s rezistencijom i/ili fenotipsku rezistenciju na rilpivirin (7/288) nego bolesnici s početnim virusnim opterećenjem > 100 000 kopija/ml (30/262).
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825) in which 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Croatian: Sigurnost emtricitabina + tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog ispitivanja (GS-US-292-1825) u kojem je jedna skupina od 55 bolesnika zaraženih virusom HIV-1 u kojih je virus bio suprimiran, sa završnim stadijem bolesti bubrega (eGFRCG < 15 ml/min) i na kroničnoj hemodijalizi, primala emtricitabin + tenofoviralafenamid u kombinaciji s elvitegravirom + kobicistatom u obliku tablete s fiksnom kombinacijom.
English: Emtricitabine + tenofovir alafenamide containing regimens Treatment-naïve and virologically suppressed HIV-1 infected adult patients In Study GS-US-292-0104 and Study GS-US-292-0111, patients received either E/C/F/TAF (n = 866) or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (n = 867) once daily, both given as FDC tablets.
Croatian: Ispitivanju GS-US-292-0104 i Ispitivanju GS-US-292-0111, bolesnici su primali ili E/C/F/TAF (n = 866) ili elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat (E/C/F/TDF) (n = 867) jedanput na dan, s tim da su obje terapije davane u obliku tableta s fiksnom kombinacijom.
English: Norethindrone (1 mg once daily)/ Rilpivirine
Croatian: Noretindron (1 mg jedanput na dan)/rilpivirin
English: The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1,498).
Croatian: Srednja vrijednost početnog broja stanica CD4+ bila je 636 stanica/mm3 (u rasponu od 263 do 1498).
English: Rifabutin (300 mg once daily)/ Rilpivirine
Croatian: Rifabutin (300 mg jedanput na dan)/rilpivirin
English: Co-administration is likely to cause significant decreases in the plasma concentrations of tenofovir alafenamide (induction of P-gp).
Croatian: Istodobna primjena će vjerojatno prouzročiti značajno smanjenje koncentracije tenofoviralafenamida u plazmi (indukcija P-gp).
English: A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Odefsey should be used.
Croatian: H2-receptora najmanje 12 sati prije ili najmanje 4 sata nakon što bi se Odefsey trebao koristiti.
English: (78.6%, 22/28) as compared to those with a baseline viral load > 100,000 copies/mL (50.0%, 4/8).
Croatian: Udio onih koji su odgovorili bio je veći u ispitanika s početnim virusnim opterećenjem ≤ 100 000 kopija/ml (78,6%, 22/28) u usporedbi s onima kod kojih je početno virusno opterećenje > 100 000 kopija/ml (50,0%, 4/8).
English: In the pooled Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients, at Week 96, there was an overall mean change from baseline in basal cortisol of -19.1 (-30.85; -7.37) nmol/L in the rilpivirine arm and of -0.6 (-13.29; 12.17) nmol/L in the efavirenz arm. At Week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine arm (+18.4 ± 8.36 nmol/L) than in the efavirenz arm (+54.1 ± 7.24 nmol/L).
Croatian: U objedinjenim ispitivanjima TMC278-C209 i TMC278-C215 faze 3 bolesnika koji prethodno nisu bili liječeni, u 96. tjednu, pojavila se ukupna srednja vrijednost promjene od početne vrijednosti za bazalni kortizol, i to od -19,1 (-30,85; -7,37) nmol/l u skupini liječenoj rilpivirinom i od -0,6 (-13,29; 12,17) nmol/l u skupini liječenoj efavirenzom.
English: No virologic data in Week 48 or 96 window
Croatian: HIV-1 RNK ≥ 50 kopija/mld Bez viroloških podataka u okviru 48. ili 96. tjedna
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 RT. Rilpivirine does not inhibit the human cellular DNA
Croatian: Aktivnost rilpivirina postignuta je nekompetitivnom inhibicijom HIV-1 RT.
English: Virologically suppressed HIV-1 infected adult patients In Study GS-US-366-1216, the efficacy and safety of switching from FTC/RPV/TDF to Odefsey were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults.
Croatian: Ispitivanju GS-US-366-1216, djelotvornost i sigurnost prebacivanja s FTC/RPV/TDF na Odefsey procijenjene su u randomiziranom, dvostruko slijepom ispitivanju u odraslih bolesnika zaraženih virusom HIV-1 u kojih je virus bio suprimiran.
English: Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Croatian: Famotidin (jedna doza od 40 mg uzeta 12 sati prije rilpivirina)/
English: AUC: ↓ 80% Cmin: ↓ 89% Cmax: ↓ 69%
Croatian: AUC: ↓ 80% Cmin: ↓ 89% Cmax: ↓ 69% Indukcija CYP3A
English: RPV + FTC/TDF (n = 550)
Croatian: FTC/RPV /TDF (n = 313)c
English: AUC: ↓ 16% Cmin: ↓ 21% Cmax: ↓ 13%
Croatian: S(+) metadon: AUC: ↓ 16% Cmin: ↓ 21% Cmax: ↓ 13%
English: Co-administration of ciclosporin is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Croatian: Očekuje se da će istodobna primjena ciklosporina povisiti koncentracije rilpivirina (inhibicija CYP3A) i tenofoviralafenamida (inhibicija P-gp) u plazmi.
English: Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1
Croatian: Famotidin (jedna doza od 40 mg uzeta 4 sata nakon rilpivirina)/
English: Co-administration may cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Croatian: Istodobna primjena može prouzročiti značajna smanjenja koncentracije rilpivirina u plazmi (indukcija CYP3A) i tenofoviralafenamida (indukcija P-gp).
English: fatigue1, 3
Croatian: osip1,3