natgillin/translations-raw huggingface dataset:
The bioequivalence of one Eviplera film-coated tablet with one emtricitabine 200 mg hard capsule, one rilpivirine (as hydrochloride) 25 mg film-coated tablet and one tenofovir disoproxil 245 mg film-coated tablet was established following single dose administration to fed, healthy subjects.
Bioekvivalencija jedne Eviplera filmom obložene tablete s jednom emtricitabin 200 mg tvrdom kapsulom, jednom rilpivirin (u obliku klorida) 25 mg filmom obložene tablete i jedne tenofovirdizoproksil 245 mg filmom obložene tablete utvrđena je nakon primjene jednostruke doze zdravim ispitanicima na pun želudac.
How to take Eviplera
Kako uzimati Evipleru
8 This adverse reaction was identified through post-marketing surveillance for tenofovir disoproxil but not observed in randomised controlled clinical studies or the expanded access program for tenofovir disoproxil.
Ova nuspojava je bila identificirana tijekom praćenja lijeka nakon stavljanja lijeka u promet tenofovirdizoproksila no nije zabilježena u randomiziranim kontroliranim kliničkim ispitivanjima ili programu proširenog pristupa tenofovirdizoproksila.
If you vomit more than 4 hours after taking Eviplera you do not need to take another tablet until your next regularly scheduled tablet.
Ako povraćate kad je prošlo više od 4 sata od uzimanja Eviplere, ne uzimajte drugu tabletu sve dok ne bude vrijeme za sljedeću prema uobičajenom rasporedu.
Eviplera 200 mg/25 mg/245 mg film-coated tablets emtricitabine/rilpivirine/tenofovir disoproxil
Eviplera 200 mg/25 mg/245 mg filmom obložene tablete emtricitabin/rilpivirin/tenofovirdizoproksil
Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Prekid terapije lijekom Eviplera u bolesnika istovremeno inficiranih HIV-om i HBV-om može biti povezan s teškim akutnim pogoršanjima hepatitisa (vidjeti dio 4.4).
Co-administration of Eviplera with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).
Primijećeno je da istovremena primjena lijeka Eviplera s inhibitorima protonske pumpe smanjuje koncentracije rilpivirina u plazmi (zbog povišenja želučanog pH), što potencijalno može dovesti do gubitka terapijskog učinka lijeka Eviplera (vidjeti dio 4.3).
Sildenafil (50 mg single dose)/ Rilpivirine1
Sildenafil (50 mg jednostruka doza)/ rilpivirin1
If Eviplera is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Ako se prekine liječenje lijekom Eviplera u bolesnika istovremeno zaraženih HIV-om i virusom hepatitisa B (HBV) te bolesnike treba pomno nadzirati zbog praćenja pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Stoga se Eviplera ne preporučuje u bolesnika s teškim oštećenjem jetre (vidjeti dijelove 4.2 i 4.4).
If a patient vomits more than 4 hours after taking Eviplera they do not need to take another dose of Eviplera until the next regularly scheduled dose.
Ako bolesnik povraća nakon više od 4 sata od uzimanja lijeka Eviplera, ne treba uzeti drugu dozu lijeka Eviplera sve do sljedeće doze prema uobičajenom rasporedu.
Emtricitabine and tenofovir are phosphorylated by cellular enzymes to form emtricitabine triphosphate and tenofovir diphosphate, respectively.
Stanični enzimi fosforiliraju emtricitabin i tenofovir u emtricitabin trifosfat odnosno tenofovirdifosfat.
• Inflammation of the kidney, passing a lot of urine and feeling thirsty
• upala bubrega, mokrenje velikih količina mokraće i osjećaj žeđi
Co-administration of Eviplera and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).
Primijećeno je da istovremena primjena lijeka Eviplera i lijekova koji induciraju CYP3A smanjuje koncentracije rilpivirina u plazmi, što potencijalno može dovesti do gubitka terapijskog učinka lijeka Eviplera (vidjeti dio 4.3).
In the cumulative week 96 pooled resistance analysis for patients receiving rilpivirine in combination with emtricitabine/tenofovir disoproxil, a greater risk of virologic failure for patients in the rilpivirine arm was observed within the first 48 weeks of these studies (11.5% in the rilpivirine arm and 4.2% in the efavirenz arm) while low rates of virologic failure, similar between the treatment arms, were observed from the week 48 to week 96 analysis (15 patients or 2.7% in the rilpivirine arm and 14 patients or 2.6% in the efavirenz arm).
U analizi objedinjenih podataka o rezistenciji iz 96. tjedna u bolesnika koji su primali rilpivirin u kombinaciji s emtricitabinom/tenofovirdizoproksilom opažen je veći rizik od virološkog neuspjeha u bolesnika u skupini koja je primala rilpivirin tijekom prvih 48 tjedana u ovim kliničkim ispitivanjima (11,5% u skupini koja je primala rilpivirin i 4,2% u skupini koja je primala efavirenz), dok su niske stope virološkog neuspjeha, koje su bile slične u obje terapijske skupine, bile opažene u analizi podataka iz razdoblja od 48. do 96. tjedna (15 bolesnika ili 2,7% u skupini koja je primala rilpivirin i 14 bolesnika ili 2,6% u skupini koja je primala efavirenz).
No dose adjustment of Eviplera is required in patients with mild or moderate hepatic impairment.
Nije potrebna prilagodba doze lijeka Eviplera u bolesnika s blagim ili umjerenim oštećenjem jetre.
Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Neklinički podaci o emtricitabinu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
In combination studies of emtricitabine with NRTIs (abacavir, didanosine, lamivudine, stavudine, tenofovir, and zidovudine), NNRTIs (delavirdine, efavirenz, nevirapine, and rilpivirine), and PIs (amprenavir, nelfinavir, ritonavir, and saquinavir), additive to synergistic effects were observed.
U ispitivanjima kombinacije emtricitabina s nukleozidnim inhibitorima reverzne transkriptaze (abakavir, didanozin, lamivudin, stavudin, tenofovir i zidovudin), nenukleozidnim inhibitorima reverzne transkriptaze (delavirdin, efavirenz, nevirapin i rilpivirin) i inhibitorima proteaze (amprenavir, nelfinavir, ritonavir i sakvinavir) primijećeni su aditivni do sinergistički učinci.
If you are taking an H2-antagonist such as famotidine, cimetidine, nizatidine or ranitidine.
• H2-antagonisti (famotidin, cimetidin, nizatidin ili ranitidin)
Antimycobacterials Rifabutin/Emtricitabine
Antimikobakterijski lijekovi Rifabutin/emtricitabin
Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000
Eviplera je indicirana za liječenje odraslih bolesnika zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1) bez poznatih mutacija povezanih s rezistencijom na skupinu nenukleozidnih inhibitora reverzne transkriptaze (NNRTI), tenofovir ili emtricitabin, i virusnim opterećenjem ≤ 100 000 HIV-1 RNK kopija/ml (vidjeti dijelove 4.2, 4.4 i 5.1).
Rilpivirine hydrochloride has not been studied in patients with severe hepatic impairment (CPT Score C).
Rilpivirinklorid nije ispitivan u bolesnika s teškim oštećenjem jetre (CPT stadij C).
Paracetamol (500 mg single dose)/ Rilpivirine1
Paracetamol (500 mg jednostruka doza)/ rilpivirin1
Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Treba izbjegavati primjenu lijeka Eviplera istovremeno ili neposredno nakon primjene nefrotoksičnih lijekova.
Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinised maize starch, polysorbate 20, croscarmellose sodium, and magnesium stearate.
Jezgra tablete: mikrokristalična celuloza, laktoza hidrat, povidon, prethodno geliran kukuruzni škrob, polisorbat 20, umrežena karmelozanatrij i magnezijev stearat
• Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).
• Rilpivirin, nenukleozidni inhibitor reverzne transkriptaze (NNRTI).
If a patient misses a dose of Eviplera within 12 hours of the time it is usually taken, the patient should take Eviplera with food as soon as possible and resume the normal dosing schedule.
Ako bolesnik propusti uzeti dozu lijeka Eviplera, a prošlo je manje od 12 sati od uobičajenog uzimanja doze, bolesnik treba uzeti lijek Eviplera s hranom čim prije i nastaviti uzimati doze prema uobičajenom rasporedu.
somnolence2
somnolencija2
Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg + 100 mg once daily)5/ Rilpivirine/Emtricitabine (25 mg/200 mg once daily)6
Sofosbuvir/velpatasvir/voksilaprevir (400 mg/100 mg/100 mg + 100 mg jedanput dnevno)5/ rilpivirin/emtricitabin (25 mg/200 mg jedanput dnevno)6
Tenofovir displayed antiviral activity in cell culture against HIV-1 subtype A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5 to 2.2 µM) and strain specific activity against HIV-2 (EC50 values ranged from 1.6 to 5.5 µM).
Tenofovir je pokazao antivirusno djelovanje u staničnoj kulturi protiv podtipova A, B, C, D, E, F, G i O virusa HIV-1 (vrijednosti EC50 u rasponu od 0,5 do 2,2 µM) i specifično djelovanje protiv soja HIV-2 (vrijednosti EC50 u rasponu od 1,6 do 5,5 µM).
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil/Emtricitabine
INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5)
• The active substances are emtricitabine, rilpivirine and tenofovir disoproxil.
• Djelatne tvari su emtricitabin, rilpivirin i tenofovirdizoproksil.
Herpesvirus antiviral agents Famciclovir/Emtricitabine
Antivirusni lijekovi protiv virusa herpesa Famciklovir/emtricitabin
In this analysis, the NNRTI resistance-associated mutations that developed most commonly in these patients were: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y and F227C.
U toj su analizi mutacije povezane s rezistencijom na nenukleozidne inhibitore reverzne transkriptaze koje su se najčešće razvile u tih bolesnika bile: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y i F227C.
How to store Eviplera
Kako čuvati Evipleru
Cases of severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including but not limited to rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia.
Tijekom praćenja lijeka Eviplera nakon stavljanja lijeka u promet zabilježeni su slučajevi teških kožnih reakcija sa sistemskim simptomima, uključujući između ostaloga osipe praćene vrućicom, mjehurima na koži, konjunktivitisom, angioedemom, povećanom funkcijom jetre prema nalazima pretraga i/ili eozinofilijom.
(rilpivirine) and 5/14 (efavirenz) were in patients with a baseline viral load of ≤ 100,000 copies/mL.
Među njima je virološki neuspjeh bio prisutan u 5/15 (rilpivirin) i 5/14 (efavirenz) bolesnika s početnim virusnim opterećenjem od ≤ 100 000 kopija/ml.
If a patient vomits within 4 hours of taking Eviplera another Eviplera tablet should be taken with food.
Ako bolesnik povraća unutar 4 sata od uzimanja lijeka Eviplera, treba uzeti drugu tabletu Eviplera s hranom.
Very common: increased pancreatic amylase2, vomiting1, 2, 3, diarrhoea1, 3, nausea1, 2, 3
povišena pankreasna amilaza2, povraćanje1, 2, 3, proljev1, 3, mučnina1, 2, 3
Concomitant use not recommended
Lijekovi s kojima se istovremena primjena ne preporučuje
Emtricitabine and tenofovir disoproxil are excreted in human milk.
Pokazalo se da se emtricitabin i tenofovirdizoproksil izlučuju u majčino mlijeko.
More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Rezistenciju povezanu s lamivudinom/emtricitabinom razvilo je više bolesnika s virološkim neuspjehom liječenih rilpivirinom nego onih s virološkim neuspjehom liječenih efavirenzom (vidjeti dio 5.1).
25-O-desacetyl-rifabutin:
25-O-dezacetil-rifabutin: AUC: ↔
c There were 17 new virologic failures between the week 48 primary analysis and week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL).
c Od primarne analize u 48. tjednu do 96. tjedna bilo je 17 novih slučajeva virološkog neuspjeha (6 bolesnika s početnim virološkim opterećenjem ≤ 100 000 kopija/ml i 11 bolesnika s početnim virološkim opterećenjem od > 100 000 kopija/ml).
Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Rilpivirin je diarilpirimidinski nenukleozidni inhibitor reverzne transkriptaze virusa HIV-1.
Co-administration of Eviplera and didanosine is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena lijeka Eviplera i didanozina (vidjeti dio 4.4).
Raltegravir/Rilpivirine
Raltegravir/rilpivirin
d There were 10 new virologic failures between the week 48 primary analysis and week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load > 100,000 copies/mL).
d Od primarne analize u 48. tjednu do 96. tjedna bilo je 10 novih slučajeva virološkog neuspjeha (3 bolesnika s početnim virološkim opterećenjem ≤ 100 000 kopija/ml i 7 bolesnika s početnim virološkim opterećenjem > 100 000 kopija/ml).
Integrase strand transfer inhibitors Raltegravir/Emtricitabine
Inhibitori prijenosa niza integraze Raltegravir/emtricitabin
• Back pain caused by kidney problems, including kidney failure.
• bolovi u leđima prouzročeni tegobama s bubrezima, uključujući zatajenje bubrega.
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera (see sections 4.2 and 5.2).
U starijih je bolesnika veća vjerojatnost da će imati smanjenu funkciju bubrega pa je stoga potreban oprez kad se starije bolesnike liječi lijekom Eviplera (vidjeti dijelove 4.2 i 5.2).
Antifungals Ketoconazole/Emtricitabine
Antimikotici Ketokonazol/emtricitabin
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).
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).
GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Deksametazon (sustavni, osim za primjenu jednostruke doze)
Co-administration of Eviplera with medicinal products that inhibit CYP3A enzyme activity has been observed to increase rilpivirine plasma concentrations.
Primijećeno je da istovremena primjena lijeka Eviplera s lijekovima koji inhibiraju aktivnost enzima CYP3A povećava koncentracije rilpivirina u plazmi.
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).
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).
Eviplera has not been studied in patients with severe hepatic impairment (CPT Score C).
Eviplera nije ispitana u bolesnika s teškim oštećenjem jetre (CPT stadij C).
• Fatty liver
• masna jetra
While you take Eviplera
Dok uzimate lijek Eviplera
Darunavir (800 mg once daily)/ Ritonavir (100 mg once daily)/ Rilpivirine1
Darunavir (800 mg jedanput na dan)/ ritonavir (100 mg jedanput na dan)/ rilpivirin1
Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Rilpivirine1 (soft capsule)
Lopinavir (400 mg dvaput na dan)/ ritonavir (100 mg dvaput na dan)/ rilpivirin1 (meke kapsule)
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.
Neklinički podaci o tenofovirdizoproksilfumaratu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
Maraviroc/Rilpivirine
Maravirok/rilpivirin
Adverse reaction Metabolism and nutrition disorders Very common: increased total cholesterol (fasted)2, increased LDL-cholesterol (fasted)2, hypophosphataemia3, 5
povišen ukupni kolesterol (natašte)2, povišen LDL kolesterol (natašte)2, hipofosfatemija3, 5
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.
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.
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).
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).
HMG CO-A REDUCTASE INHIBITORS Atorvastatin/Emtricitabine
INHIBITORI REDUKTAZE HMG-CoA
Rilpivirine is primarily metabolised by CYP3A Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Tako lijekovi koji induciraju ili inhibiraju CYP3A mogu utjecati na klirens rilpivirina (vidjeti dio 5.2).
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.
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.
• Rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
• 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
• Damage to kidney tubule cells
• oštećenje stanica bubrežnih kanalića
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.
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.
ANALGESICS Paracetamol/Emtricitabine
Paracetamol/emtricitabin
Esomeprazole2
Esomeprazol2
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.
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.
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).
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).
Other antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Drugi antivirusni lijekovi Ledipasvir/sofosbuvir (90 mg/400 mg jedanput dnevno)/emtricitabin/rilpivirin/ tenofovirdizoproksil (200 mg/25 mg/245 mg jedanput dnevno)
osteomalacia (manifested as bone pain and infrequently contributing to fractures)3, 5, 8, myopathy3, 5 Renal and urinary disorders Uncommon:
osteomalacija (očituje se kao bol u kostima i nerijetko pridonosi prijelomima)3, 5, 8, miopatija3, 5
Genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1).
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).
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.
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.
Simeprevir: AUC: ↔ Cmax: ↑ 10%
Simeprevir: AUC: ↔ Cmax: ↑ 10% Cmin: ↔
The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment.
Farmakokinetika emtricitabina nije ispitivana u bolesnika s oštećenjem jetre.
Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Istovremena primjena vjerojatno će prouzročiti značajno smanjenje koncentracije rilpivirina u plazmi (indukcija enzima CYP3A).
Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than in the rilpivirine arm.
U 96. tjednu, prekidi liječenja zbog nuspojava bili su češći u skupini koja je primala efavirenz nego u skupini koja je primala rilpivirin.
Sofosbuvir/Tenofovir disoproxil
Sofosbuvir/tenofovirdizoproksil
AUC: ↔ Cmin: ↓ 15% Cmax: ↑ 35%
Atorvastatin: AUC: ↔ Cmin: ↓ 15% Cmax: ↑ 35%
The pharmacokinetics of rilpivirine has not been studied in patients with renal insufficiency.
Farmakokinetika rilpivirina nije ispitana u bolesnika s bubrežnom insuficijencijom.
Digoxin/Rilpivirine
Digoksin/rilpivirin
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.
b Razlika u stopi odgovora je 1% (95% interval pouzdanosti od −3% do 6%) pomoću normalne aproksimacije.
Antacids should only be administered either at least 2 hours before or at least 4 hours after Eviplera.
Antacidi se smiju primjenjivati samo najmanje 2 sata prije ili najmanje 4 sata nakon uzimanja lijeka Eviplera.
The combination of Eviplera with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Kombinacija lijeka Eviplera s ovim makrolidnim antibioticima može prouzročiti povećanje koncentracija rilpivirina u plazmi (inhibicija enzima CYP3A).
Rifabutin (300 mg once daily)/ Rilpivirine3
Rifabutin (300 mg jedanput na dan)/ rilpivirin3