FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment outweigh the potential risks (see sections 4.4 and 5.2).
Croatian: Stoga se u bolesnika s blagim oštećenjem bubrega Eviplera treba primjenjivati samo ako je moguća korist veća od mogućih rizika (vidjeti dijelove 4.4 i 5.2).
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Croatian: Deksametazon (sustavni, osim za primjenu jednostruke doze)
English: Co-administration of Eviplera with medicinal products that inhibit CYP3A enzyme activity has been observed to increase rilpivirine plasma concentrations.
Croatian: Primijećeno je da istovremena primjena lijeka Eviplera s lijekovima koji inhibiraju aktivnost enzima CYP3A povećava koncentracije rilpivirina u plazmi.
English: Emtricitabine displayed antiviral activity in cell culture against HIV-1 subtype A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Croatian: Emtricitabin je pokazao antivirusno djelovanje u staničnoj kulturi protiv podtipova HIV-1 A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,007 do 0,075 µM) i specifično djelovanje protiv soja HIV-2 (vrijednosti EC50 bile su u rasponu od 0,007 do 1,5 µM).
English: Eviplera has not been studied in patients with severe hepatic impairment (CPT Score C).
Croatian: Eviplera nije ispitana u bolesnika s teškim oštećenjem jetre (CPT stadij C).
English: • Fatty liver
Croatian: • masna jetra
English: While you take Eviplera
Croatian: Dok uzimate lijek Eviplera
English: Darunavir (800 mg once daily)/ Ritonavir (100 mg once daily)/ Rilpivirine1
Croatian: Darunavir (800 mg jedanput na dan)/ ritonavir (100 mg jedanput na dan)/ rilpivirin1
English: Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Rilpivirine1 (soft capsule)
Croatian: Lopinavir (400 mg dvaput na dan)/ ritonavir (100 mg dvaput na dan)/ rilpivirin1 (meke kapsule)
English: Non-clinical data on tenofovir disoproxil reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Croatian: Neklinički podaci o tenofovirdizoproksilfumaratu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: Maraviroc/Rilpivirine
Croatian: Maravirok/rilpivirin
English: Adverse reaction Metabolism and nutrition disorders Very common: increased total cholesterol (fasted)2, increased LDL-cholesterol (fasted)2, hypophosphataemia3, 5
Croatian: povišen ukupni kolesterol (natašte)2, povišen LDL kolesterol (natašte)2, hipofosfatemija3, 5
English: Non-clinical data on rilpivirine hydrochloride reveal no special hazard for humans based on studies of safety pharmacology, drug disposition, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Croatian: Neklinički podaci o rilpivirinkloridu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, farmakokinetike lijeka, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: Exacerbations of hepatitis after discontinuation of treatment In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis have occurred after discontinuation of treatment (see section 4.4).
Croatian: U bolesnika s HIV-om koji su istovremeno imali infekciju HBV-om, nakon prekida liječenja pojavili su se klinički i laboratorijski dokazi hepatitisa (vidjeti dio 4.4).
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin/Emtricitabine
Croatian: INHIBITORI REDUKTAZE HMG-CoA
English: Rilpivirine is primarily metabolised by CYP3A Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Croatian: Tako lijekovi koji induciraju ili inhibiraju CYP3A mogu utjecati na klirens rilpivirina (vidjeti dio 5.2).
English: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng•h/mL in patients with normal renal function, to 3,064 (30%) ng•h/mL, 6,009 (42%) ng•h/mL and 15,985 (45%) ng•h/mL, in patients with mild, moderate and severe renal impairment, respectively.
Croatian: Srednja je vrijednost (%CV) izloženosti tenofoviru porasla s 2185 (12%) ng•h/ml u bolesnika s normalnom funkcijom bubrega na 3064 (30%) ng•h/ml u bolesnika s blagim, 6009 (42%) ng•h/ml u bolesnika s umjerenim i 15 985 (45%) ng•h/ml u bolesnika s teškim oštećenjem bubrega.
English: • Rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
Croatian: • osipi (uključujući crvene točke ili mrlje, ponekad s mjehurićima i otokom kože) koji mogu biti alergijska reakcija, svrbež, promjene boje kože uključujući nastanak tamnih mrlji na koži
English: • Damage to kidney tubule cells
Croatian: • oštećenje stanica bubrežnih kanalića
English: The mean (%CV) emtricitabine drug exposure increased from 12 (25%) µg•h/mL in patients with normal renal function, to 20 (6%) µg•h/mL, 25 (23%) µg•h/mL and 34 (6%) µg•h/mL, in patients with mild, moderate and severe renal impairment, respectively.
Croatian: Srednja je vrijednost (% koeficijenta varijacije, CV) izloženosti emtricitabinu porasla s 12 (25%) µg•h/ml u bolesnika s normalnom funkcijom bubrega na 20 (6%) µg•h/ml u bolesnika s blagim, 25 (23%) µg•h/ml u bolesnika s umjerenim i 34 (6%) µg•h/ml u bolesnika s teškim oštećenjem bubrega.
English: ANALGESICS Paracetamol/Emtricitabine
Croatian: Paracetamol/emtricitabin
English: Esomeprazole2
Croatian: Esomeprazol2
English: At week 96 the mean changes in CD4+ cell count from baseline were +226 x 106 cells/L and +222 x 106 cells/L for the rilpivirine and efavirenz treatment arms, respectively, of patients receiving the emtricitabine/tenofovir disoproxil background regimen.
Croatian: U 96. tjednu, srednje vrijednosti promjena u broju stanica CD4+ od početnih vrijednosti u bolesnika koji su primali emtricitabin/tenofovirdizoproksil kao osnovni terapijski režim bile su +226 x 106 stanica/l u skupini liječenoj rilpivirinom i +222 x 106 stanica/l u skupini liječenoj efavirenzom.
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil in clinical practice (see section 4.8).
Croatian: Pri uporabi tenofovirdizoproksila u kliničkoj praksi, zabilježeno je zatajenje bubrega, oštećenje bubrega, povišen kreatinin, hipofosfatemija i proksimalna tubulopatija (uključujući Fanconijev sindrom) (vidjeti dio 4.8).
English: Other antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Croatian: Drugi antivirusni lijekovi Ledipasvir/sofosbuvir (90 mg/400 mg jedanput dnevno)/emtricitabin/rilpivirin/ tenofovirdizoproksil (200 mg/25 mg/245 mg jedanput dnevno)
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)3, 5, 8, myopathy3, 5 Renal and urinary disorders Uncommon:
Croatian: osteomalacija (očituje se kao bol u kostima i nerijetko pridonosi prijelomima)3, 5, 8, miopatija3, 5
English: Genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1).
Croatian: U primjeni lijeka Eviplera treba se rukovoditi nalazima testiranja genotipske rezistencije i/ili prethodno dobivenim podacima o rezistenciji (vidjeti dijelove 4.4 i 5.1).
English: Resistance outcomes, including cross-resistance to other NNRTIs, in patients receiving rilpivirine hydrochloride in combination with emtricitabine/tenofovir disoproxil in Phase III studies (C209 and C215 pooled data) and experiencing virological failure, are shown in Table 3 below.
Croatian: Tablica 3 niže prikazuje ishode rezistencije, uključujući križnu rezistenciju na druge NNRTI-eve, u bolesnika koji su primali rilpivirinklorid u kombinaciji s emtricitabinom/tenofovirdizoproksilom u ispitivanjima III. faze (objedinjeni podaci iz ispitivanja C209 i C215), u kojih je nastupio virološki neuspjeh.
English: Simeprevir: AUC: ↔ Cmax: ↑ 10%
Croatian: Simeprevir: AUC: ↔ Cmax: ↑ 10% Cmin: ↔
English: The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment.
Croatian: Farmakokinetika emtricitabina nije ispitivana u bolesnika s oštećenjem jetre.
English: Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Croatian: Istovremena primjena vjerojatno će prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
English: Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than in the rilpivirine arm.
Croatian: U 96. tjednu, prekidi liječenja zbog nuspojava bili su češći u skupini koja je primala efavirenz nego u skupini koja je primala rilpivirin.
English: Sofosbuvir/Tenofovir disoproxil
Croatian: Sofosbuvir/tenofovirdizoproksil
English: AUC: ↔ Cmin: ↓ 15% Cmax: ↑ 35%
Croatian: Atorvastatin: AUC: ↔ Cmin: ↓ 15% Cmax: ↑ 35%
English: The pharmacokinetics of rilpivirine has not been studied in patients with renal insufficiency.
Croatian: Farmakokinetika rilpivirina nije ispitana u bolesnika s bubrežnom insuficijencijom.
English: Digoxin/Rilpivirine
Croatian: Digoksin/rilpivirin
English: Discontinued for non-AE reasone n = total number of patients per treatment group a ITT TLOVR = Intention to treat time to loss of virologic response b The difference of response rate is 1% (95% confidence interval -3% to 6%) using normal approximation.
Croatian: b Razlika u stopi odgovora je 1% (95% interval pouzdanosti od −3% do 6%) pomoću normalne aproksimacije.
English: Antacids should only be administered either at least 2 hours before or at least 4 hours after Eviplera.
Croatian: Antacidi se smiju primjenjivati samo najmanje 2 sata prije ili najmanje 4 sata nakon uzimanja lijeka Eviplera.
English: The combination of Eviplera with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Croatian: Kombinacija lijeka Eviplera s ovim makrolidnim antibioticima može prouzročiti povećanje koncentracija rilpivirina u plazmi (inhibicija enzima CYP3A).
English: Rifabutin (300 mg once daily)/ Rilpivirine3
Croatian: Rifabutin (300 mg jedanput na dan)/ rilpivirin3
English: An increased risk of adverse reactions associated with Eviplera and its individual components may be seen in the event of an overdose.
Croatian: U slučaju predoziranja moguć je povećani rizik od nuspojava povezanih s lijekom Eviplera i njegovim pojedinačnim djelatnim tvarima.
English: Omeprazole (20 mg once daily)/ Rilpivirine1
Croatian: Omeprazol (20 mg jedanput na dan)/ rilpivirin1
English: CD4+ median increase from baseline (x 106 cells/L)
Croatian: Medijan povećanja broja CD4+ stanica u odnosu na početak (x 106 stanica/l)
English: Eviplera must not be used in combination with proton pump inhibitors as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Croatian: Eviplera se ne smije primjenjivati u kombinaciji s inhibitorima protonske pumpe, jer će istovremena primjena vjerojatno prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (smanjena apsorpcija, povišenje želučanog pH).
English: Eviplera should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may cause significant dose dependent decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Croatian: Eviplera se ne smije primjenjivati u kombinaciji s deksametazonom za sustavnu primjenu (osim kao jednostruke doze), jer istovremena primjena može prouzročiti značajno, o dozi ovisno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
English: It is unlikely that a dose adjustment would be required for Eviplera in patients with mild or moderate hepatic impairment (see sections 4.2 and 5.2).
Croatian: Prilagodba doze lijeka Eviplera u bolesnika s blagim ili umjerenim oštećenjem jetre vjerojatno neće biti potrebna (vidjeti dijelove 4.2 i 5.2).
English: Indigo carmine aluminium lake Lactose monohydrate Polyethylene glycol Red iron oxide
Croatian: Film ovojnica hipromeloza boja indigo carmine aluminium lake laktoza hidrat polietilenglikol željezov oksid, crveni boja sunset yellow aluminium lake (E110)
English: Resistance testing and/or historical resistance data should guide the use of Eviplera (see section 5.1).
Croatian: U primjeni lijeka Eviplera treba se rukovoditi testiranjem rezistencije i/ili prethodno dobivenim podacima o rezistenciji (vidjeti dio 5.1).
English: Sex Male Female Ethnicity White Black/African American Asian Other Not allowed to ask per local regulations Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/mL Median baseline CD4+ cell count (range), x 106 cells/L Percentage of patients with HBV/HCV co-infection
Croatian: Medijan početne vrijednosti HIV-1 RNK (raspon) log10 kopija/ml u plazmi Medijan početnog broja stanica CD4+ (raspon), × 106 stanica/l Postotak bolesnika s istovremenom infekcijom HBV/HCV
English: Simeprevir (150 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Croatian: Simeprevir (150 mg jedanput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
English: *compared to 25 mg once daily rilpivirine alone
Croatian: Cmax: ↑ 43%* *u usporedbi samo s 25 mg rilpivirina jedanput na dan
English: Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Croatian: Sofosbuvir (400 mg jedanput dnevno)/ rilpivirine (25 mg jedanput dnevno)
English: Patients had to be stably suppressed for at least 8 weeks prior to study entry, have no current or past history of resistance to any of the three components of Eviplera, and have HIV-1 RNA < 50 copies/mL at screening.
Croatian: Bolesnici su trebali imati stabilnu supresiju najmanje 8 tjedana prije ulaska u ispitivanje, nisu smjeli imati, ni tada ni prije, rezistenciju na neku od tri komponente lijeka Eviplera te su morali imati količinu
English: Simeprevir (150 mg once daily)/ Rilpivirine (25 mg once daily)
Croatian: Simeprevir (150 mg jedanput na dan)/ rilpivirin (25 mg jedanput na dan)
English: Rifampicin (600 mg once daily)/ Rilpivirine1
Croatian: Rifampicin (600 mg jedanput na dan)/ rilpivirin1
English: By baseline viral load (copies/mL)
Croatian: Prema početnom virusnom opterećenju (kopija/ml)
English: However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp that are more sensitive to intestinal P-gp inhibition (e.g. dabigatran etexilate).
Croatian: P-gp koji su osjetljiviji na intestinalnu inhibiciju P-gp (npr. dabigatran eteksilat).
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Croatian: Sofosbuvir/velpatasvir (400 mg/100 mg jedanput dnevno)/ emtricitabin/rilpivirin/tenofovirdizoproksil (200 mg/25 mg/245 mg jedanput dnevno)
English: (may affect up to 1 in 1,000 people)
Croatian: (mogu se javiti u manje od 1 na 1000 osoba)
English: ORAL CONTRACEPTIVES Ethinylestradiol/Norethindrone/ Emtricitabine
Croatian: Etinilestradiol/noretindron/emtricitabin
English: Norgestimate/Ethinylestradiol/ Tenofovir disoproxil
Croatian: Norgestimat/etinilestradiol/ tenofovirdizoproksil
English: 5 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Croatian: 5 Ova nuspojava može nastati kao posljedica proksimalne bubrežne tubulopatije.
English: • Decreases in potassium in the blood
Croatian: • sniženje kalija u krvi
English: Rilpivirine hydrochloride
Croatian: Rilpivirinklorid
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Polysorbate 20
Croatian: Jezgra tablete karmelozanatrij, umrežena laktoza hidrat magnezijev stearat celuloza, mikrokristalična polisorbat 20 povidon kukuruzni škrob, prethodno geliran
English: AUC: ↑ 16%* Cmin: ↔* Cmax: ↑ 43%*
Croatian: AUC: ↑ 16%* Cmin: ↔*
English: ANTIDIABETICS Metformin/Emtricitabine
Croatian: LIJEKOVI Metformin/emtricitabin
English: A subgroup analysis of the virologic response (< 50 HIV-1 RNA copies/mL) at both 48 weeks and 96 weeks, and virologic failure by baseline viral load (pooled data from the two Phase III clinical studies, C209 and C215, for patients receiving the emtricitabine/tenofovir disoproxil background regimen) is presented in Table 5.
Croatian: Analiza virološkog odgovora (< 50 HIV-1 RNK kopija/ml) prema podskupinama u 48. i 96. tjednu te virološkog neuspjeha prema početnom virusnom opterećenju (objedinjeni podaci iz dvaju kliničkih ispitivanja III. faze, C209 i C215, za bolesnike koji su primali emtricitabin/tenofovirdizoproksil kao osnovni terapijski režim) prikazana je u tablici 5. Stopa odgovora (potvrđeno nemjerljivo virusno opterećenje < 50 HIV-1 RNK kopija/ml) u 96. tjednu u skupini koja je primala rilpivirin bila je usporediva s onom u skupini koja je primala efavirenz.
English: Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1
Croatian: Famotidin (40 mg jednostruka doza koja se uzima 4 sata nakon rilpivirina)/rilpivirin1
English: Ketoconazole (400 mg once daily)/ Rilpivirine1
Croatian: Ketokonazol (400 mg jedanput na dan)/ rilpivirin1
English: Norethindrone (1 mg once daily)/ Rilpivirine
Croatian: Noretindron (1 mg jedanput na dan)/ rilpivirin
English: Rifampicin (600 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Croatian: Rifampicin (600 mg jedanput na dan)/ tenofovirdizoproksil (245 mg jedanput na dan)
English: Atorvastatin (40 mg once daily)/ Rilpivirine1
Croatian: Atorvastatin (40 mg jedanput na dan)/ rilpivirin1
English: AUC: ↑ 49% C12h: ↑ 3% Cmax: ↑ 64%
Croatian: AUC: ↑ 49% C12h: ↑ 3%
English: Table 4: Demographic and baseline characteristics of antiretroviral treatment-naïve HIV-1 infected adult patients in studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96
Croatian: Tablica 4: Demografske značajke i početne značajke bolesti u odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, u ispitivanjima C209 i C215 (objedinjeni podaci za bolesnike koji su primali rilpivirinklorid ili efavirenz u kombinaciji s emtricitabinom/tenofovirdizoproksilom) u 96. tjednu
English: Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 4.4).
Croatian: Bolesnicima s umjerenim ili teškim oštećenjem bubrega potrebna je prilagodba intervala doziranja emtricitabina i tenofovirdizoproksila koja se ne može postići kombiniranom tabletom (vidjeti dijelove 4.2 i 4.4).
English: • Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).
Croatian: Emtricitabin, nukleozidni inhibitor reverzne transkriptaze (NRTI).
English: Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Croatian: Famotidin (40 mg jednostruka doza koja se uzima 12 sati prije rilpivirina)/rilpivirin1
English: Paracetamol/Tenofovir disoproxil
Croatian: Paracetamol/ tenofovirdizoproksil
English: Lopinavir/Ritonavir:
Croatian: Lopinavir/ritonavir: AUC: ↔
English: At 96 weeks in the pooled Phase III C209 and C215 studies of treatment-naïve patients, in the rilpivirine arm the mean change from baseline in total cholesterol (fasted) was 5 mg/dL, in high-density lipoprotein (HDL)-cholesterol (fasted) 4 mg/dL, in low density lipoprotein (LDL)-cholesterol (fasted) 1 mg/dL, and in triglycerides (fasted) -7 mg/dL. At 48 weeks in Phase III study GS-US-264-0106 of virologically suppressed patients switching to Eviplera from a regimen containing a ritonavir-boosted PI, the mean change from baseline in total cholesterol (fasted) was -24 mg/dL, in HDL-cholesterol (fasted) -2 mg/dL, in LDL-cholesterol (fasted) -16 mg/dL, and in triglycerides (fasted) -64 mg/dL.
Croatian: Prema objedinjenim podacima nakon 96 tjedana u ispitivanjima III. faze C209 i C215 na bolesnicima koji prethodno nisu bili liječeni, u skupinama koje su primale rilpivirin srednja vrijednost promjene od početne vrijednosti ukupnog kolesterola (natašte) bila je 5 mg/dl, HDL (lipoprotein visoke gustoće) kolesterola (natašte) 4 mg/dl, LDL (lipoprotein niske gustoće) kolesterola (natašte) 1 mg/dl, a triglicerida (natašte) −7 mg/dl.
English: Table 6: Phenotypic resistance outcomes from studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96 (based on resistance analysis)
Croatian: Tablica 6: Ishodi fenotipske rezistencije u ispitivanjima C209 i C215 (objedinjeni podaci za bolesnike koji su primali rilpivirinklorid ili efavirenz u kombinaciji s emtricitabinom/tenofovirdizoproksilom) u 96. tjednu (na temelju analize rezistencije)
English: The combination of Eviplera and antacids should be used with caution as co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, gastric pH increase).
Croatian: Kombinaciju lijeka Eviplera i antacida treba primjenjivati s oprezom, jer istovremena primjena može prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (smanjena apsorpcija, povišenje želučanog pH).
English: Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Croatian: Bolesnicima s umjerenim ili teškim oštećenjem bubrega potrebna je prilagodba intervala doziranja emtricitabina i tenofovirdizoproksila koja se ne može postići kombiniranom tabletom (vidjeti dijelove 4.2 i 5.2).
English: Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna filmom obložena tableta sadrži 200 mg emtricitabina, 25 mg rilpivirina (u obliku klorida) i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: The most common emergent resistance mutations in Eviplera-treated patients were M184V/I and E138K in RT. All patients remained susceptible to tenofovir.
Croatian: Najčešće mutacije povezane s rezistencijom koja se pojavila na liječenje u bolesnika liječenih lijekom Eviplera bile su MV184V/I i E138K u RT.
English: Immune system disorders Common:
Croatian: Poremećaji imunološkog sustava
English: Table 3: Phenotypic resistance and cross-resistance outcomes from studies C209 and C215 (pooled data) for patients receiving rilpivirine hydrochloride in combination with emtricitabine/tenofovir disoproxil at week 96 (based on resistance analysis)
Croatian: Tablica 3: Ishodi ispitivanja fenotipske rezistencije i križne rezistencije u ispitivanjima C209 i C215 (objedinjeni podaci) u bolesnika koji su primali rilpivirinklorid u kombinaciji s emtricitabinom/tenofovirdizoproksilom u 96. tjednu (na temelju analize rezistencije)
English: Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.4 and 5.2).
Croatian: Bolesnicima s umjerenim ili teškim oštećenjem bubrega potrebno je prilagoditi interval doziranja emtricitabina i tenofovirdizoproksila, što se ne može postići kombiniranom tabletom (vidjeti dijelove 4.4 i 5.2).
English: Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1
Croatian: Famotidin (40 mg jednostruka doza koja se uzima 2 sata prije rilpivirina)/rilpivirin1
English: Each Eviplera film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna filmom obložena tableta lijeka Eviplera sadrži 200 mg emtricitabina, 25 mg rilpivirina (u obliku klorida) i 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).