natgillin/translations-raw huggingface dataset:
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to Eviplera or all of its components in randomised controlled clinical studies (n = 1,261).
Kategorija pogostnosti je bila ocenjena s statističnim izračunom na podlagi skupnega števila bolnikov, izpostavljenih zdravilu Eviplera ali njegovim sestavinam v randomiziranih kontroliranih kliničnih študijah (n = 1261).
Resistance testing and/or historical resistance data should guide the use of Eviplera (see section 5.1).
Testiranje rezistence in/ali podatki o rezistenci v anamnezi morajo biti vodilo pri uporabi zdravila Eviplera (glejte poglavje 5.1).
Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (creatinine clearance (CrCl) 50-80 mL/min).
Omejeni podatki iz kliničnih študij podpirajo odmerjanje zdravila Eviplera enkrat dnevno pri bolnikih z blago ledvično okvaro (očistek kreatinina (CrCl, creatinine clearance) 50-80 ml/min).
Severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia (see section 4.4).
Iz izkušenj v obdobju trženja zdravila Eviplera so poročali o hudih kožnih reakcijah s sistemskimi simptomi, vključno z izpuščaji, ki jih spremljajo zvišana telesna temperatura, mehurji, konjunktivitis, angioedem, zvišani rezultati testov jetrne funkcije in/ali eozinofilija (glejte poglavje 4.4).
If a patient vomits within 4 hours of taking Eviplera another Eviplera tablet should be taken with food.
Če bolnik v roku 4 ur od jemanja zdravila Eviplera bruha, bi moral vzeti drugo tableto zdravila Eviplera s hrano.
Eviplera should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
Zdravilo Eviplera je treba uporabljati previdno, če se uporablja sočasno z zdravili z znanim tveganjem za Torsade de Pointes.
No human data on the effect of Eviplera on fertility are available.
Ni podatkov o učinkih zdravila Eviplera na sposobnost razmnoževanja pri ljudeh.
Eviplera should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil or tenofovir alafenamide.
Zdravila Eviplera ne sme sočasno uporabljati z drugimi zdravili, ki vsebujejo emtricitabin, dizoproksiltenofovirat ali tenofoviralafenamidijev fumarat.
H2-RECEPTOR ANTAGONISTS Famotidine/Emtricitabine
ANTAGONISTI RECEPTORJEV H2
Eviplera should not be administered concomitantly with rilpivirine hydrochloride unless needed for dose adjustment with rifabutin (see sections 4.2 and 4.5).
Zdravila Eviplera se ne sme dajati skupaj z rilpivirinijevim kloridom, razen če je to potrebno za prilagoditev odmerka pri uporabi z rifabutinom (glejte poglavji 4.2 in 4.5).
Rilpivirine hydrochloride has not been studied in patients with severe hepatic impairment (CPT Score C).
Rilpivirinijevega klorida niso proučevali pri bolnikih s hudo jetrno okvaro (stopnje C po CPT).
The pharmacokinetics of emtricitabine has not been studied in patients with varying degrees of hepatic insufficiency.
Farmakokinetične lastnosti emtricitabina še niso bile proučevane na bolnikih z različnimi stopnjami jetrne insuficience.
Co-administration of Eviplera and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Sočasna uporaba zdravila Eviplera in didanozina ni priporočljiva, saj povzroča povečanje sistemske izpostavljenosti didanozinu za 40-60 %, kar lahko poveča tveganje za pojav neželenih učinkov, povezanih z didanozinom (glejte poglavje 4.5).
Co-administration of Eviplera and didanosine is not recommended (see section 4.4).
Sočasna uporaba zdravila Eviplera in didanozina se ne priporoča (glejte poglavje 4.4).
Cmin: N/A Tenofovir:
Cmin: ni bilo ovrednoteno tenofovir:
Eviplera must be administered with food to ensure optimal absorption (see section 4.2).
Za zagotavljanje optimalne absorpcije je treba zdravilo Eviplera jemati s hrano (glejte poglavje 4.2).
Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Na emtricitabin rezistentni virusi s substitucijo M184V/I so bili navzkrižno rezistentni na lamivudin, vendar so ohranili občutljivost na didanozin, stavudin, tenofovir in zidovudin.
• Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor (NtRTI).
• dizoproksiltenofovirat, nukleotidni zaviralec reverzne transkriptaze (NtRTI)
Discontinued study drug due to AE or deathd
Prekinitev uporabe študijskega zdravila zaradi neželenega učinka ali smrtid
• Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).
• rilpivirin, nenukleozidni zaviralec reverzne transkriptaze (NNRTI)
Adverse reaction Metabolism and nutrition disorders Very common: increased total cholesterol (fasted)2, increased LDL-cholesterol (fasted)2, hypophosphataemia3, 5
zvišanje skupnega holesterola (na tešče)2, zvišanje holesterola LDL (na tešče)2, hipofosfatemija3, 5
Studies in animals have shown limited placenta passage of rilpivirine.
Študije na živalih so pokazale, da rilpivirin prehaja skozi placento v omejenih količinah.
angioedema1, 3, 6, severe skin reactions with systemic symptoms7 Musculoskeletal and connective tissue disorders Very common: elevated creatine kinase1
angioedem1, 3, 6, hude kožne reakcije s sistemskimi simptomi7
Eviplera should not be administered concomitantly with rilpivirine hydrochloride unless needed for dose adjustment with rifabutin (see section 4.2).
Zdravila Eviplera se ne sme dajati skupaj z rilpivirinijevim kloridom, razen če je to potrebno za prilagoditev odmerka pri uporabi z rifabutinom (glejte poglavje 4.2).
(may affect more than 1 in 10 people)
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
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).
Prekinitev zdravljenja z zdravilom Eviplera pri bolnikih s hkratno HIV in HBV okužbo je lahko povezana s hudimi akutnimi poslabšanji hepatitisa (glejte poglavje 4.4).
There is limited information regarding the use of Eviplera in patients with mild or moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Score A or B).
Podatkov o uporabi zdravila Eviplera pri bolnikih z blago ali zmerno jetrno okvaro (stopnje A ali B po Child-Pugh-Turcotteovi (CPT) lestvici je malo.
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).
Zato naj se zdravilo Eviplera pri bolnikih z blago ledvično okvaro uporablja samo, če morebitne koristi zdravljenja odtehtajo morebitna tveganja (glejte poglavji 4.4 in 5.2).
Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment are considered to outweigh the potential risks (see sections 4.2 and 4.4).
Zato naj se zdravilo Eviplera pri bolnikih z blago ledvično okvaro uporablja samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja (glejte poglavji 4.2 in 4.4).
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
Zdravilo Eviplera je indicirano za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1) brez znanih mutacij, povezanih z rezistenco na razred nenukleozidnih zaviralcev reverzne transkriptaze (NNRTI), tenofovir ali emtricitabin in z virusno obremenitvijo ≤ 100.000 HIV-1 RNA kopij/ml (glejte poglavja 4.2, 4.4 in 5.1).
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).
Pri bolnikih, okuženih z virusom HIV, ki imajo hkratno okužbo z virusom HBV, so se po prekinitvi zdravljenja pokazali klinični in laboratorijski znaki hepatitisa (glejte poglavje 4.4).
Other NNRTIs It is not recommended to co-administer Eviplera with other NNRTIs.
Drugi NNRTI Sočasna uporaba zdravila Eviplera z drugimi NNRTI-ji se ne priporoča.
The pharmacokinetics of rilpivirine has not been studied in patients with renal insufficiency.
Farmakokinetike rilpivirina niso proučevali pri bolnikih z ledvično insuficienco.
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).
Opazili so, da sočasna uporaba zdravila Eviplera in zdravil, ki inducirajo CYP3A, povzroči zmanjšanje koncentracij rilpivirina v plazmi, kar lahko zmanjša terapevtski učinek zdravila Eviplera (glejte poglavje 4.3).
The efficacy, safety, and pharmacokinetics of switching from efavirenz/emtricitabine/tenofovir disoproxil STR to Eviplera STR were evaluated in an open-label study in virologically suppressed HIV-1 infected adults.
Učinkovitost, varnost in farmakokinetiko prehoda z režima odmerjanja z eno samo tableto efavirenza/emtricitabina/dizoproksiltenofovirata na zdravilo Eviplera v režimu odmerjanja z eno samo tableto so ocenili v odprti študiji pri bolnikih z virološko supresijo, okuženih z virusom HIV-1.
Cmin: N/A Emtricitabine:
Cmin: ni bilo ovrednoteno emtricitabin:
If Eviplera is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day is recommended to be taken concomitantly with Eviplera, for the duration of the rifabutin coadministration (see section 4.5).
Pri sočasnem dajanju zdravila Eviplera z rifabutinom se priporoča dodatna 25 mg tableta rilpivirina na dan, ki naj se jemlje sočasno z zdravilom Eviplera ves čas trajanja sočasne uporabe rifabutina (glejte poglavje 4.5).
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 pokazal protiretrovirusno aktivnost v celični kulturi proti podtipom A, B, C, D, E, F, G in O virusa HIV-1 (vrednosti EC50 so bile v razponu od 0,5 do 2,2 µM) in aktivnost, specifično za sev, proti virusu HIV-2 (vrednost EC50 so bile v razponu od 1,6 do 5,5 µM).
Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinised maize starch, polysorbate 20, croscarmellose sodium, and magnesium stearate.
Jedro tablete: mikrokristalna celuloza, laktoza monohidrat, povidon, predgelirani koruzni škrob, polisorbat 20, premreženi natrijev karmelozat in magnezijev stearat
Lansoprazole2
lansoprazol2
Interaction not studied with any of the components of Eviplera.
Interakcij z drugimi sestavinami zdravila Eviplera niso preučevali.
Eviplera should be administered with caution to elderly patients (see sections 4.4 and 5.2).
Zdravilo Eviplera je treba bolnikom starostnikom dajati previdno (glejte poglavji 4.4 in 5.2).
(rilpivirine) and 5/14 (efavirenz) were in patients with a baseline viral load of ≤ 100,000 copies/mL.
Med temi virološkimi neuspehi je bilo 5/15 (rilpivirin) in 5/14 (efavirenz) bolnikov z začetno virusno obremenitvijo ≤ 100.000 kopij/ml.
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.
Če bolnik bruha več kot 4 ure po jemanju zdravila Eviplera, mu ni treba vzeti drugega odmerka zdravila Eviplera, dokler ni čas za naslednji odmerek po režimu.
For those patients failing therapy with Eviplera and who developed resistance to Eviplera cross-resistance to other approved NNRTIs (etravirine, efavirenz, nevirapine) was generally seen.
Rezistenca na emtricitabin/lamivudin Rezistenca na rilpivirin Rezistenca na efavirenz Za bolnike, pri katerih zdravljenje z zdravilom Eviplera ni bilo uspešno in pri katerih se je pojavila rezistenca na zdravilo Eviplera, so praviloma opazili navzkrižno rezistenco na druge odobrene NNRTI (etravirin, efavirenz, nevirapin).
Co-administration of Eviplera and didanosine is not recommended since exposure to didanosine is significantly increased following co-administration with tenofovir disoproxil, which may increase the risk of didanosine-related adverse reactions (see section 4.5).
Sočasna uporaba zdravila Eviplera in didanozina ni priporočljiva, saj se izpostavljenost didanozinu znatno poveča po sočasnem dajanju dizoproksiltenofovirata, kar lahko poveča tveganje pojava neželenih učinkov, povezanih z didanozinom (glejte poglavje 4.5).
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 Med primarno analizo v 48. tednu in 96. tednom se je pojavilo 17 novih viroloških neuspehov (6 bolnikov z začetno virusno obremenitvijo ≤ 100.000 kopij/ml in 11 bolnikov z začetno virusno obremenitvijo > 100.000 kopij/ml).
(may affect up to 1 in 100 people)
Občasni:pojavijo se lahko pri največ 1 od 100 bolnikov
3 Adverse reaction identified for tenofovir disoproxil.
3 Neželeni učinek, ki so ga zabeležili za dizoproksiltenofovirat.
Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Zato se zdravilo Eviplera ne priporoča pri bolnikih s hudo jetrno okvaro (glejte poglavji 4.2 in 4.4)
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.
Iz izkušenj v obdobju trženja zdravila Eviplera so poročali o primerih hudih kožnih reakcij in sistemskih simptomov, ki med drugim vključujejo izpuščaje, ki jih spremljajo zvišana telesna temperatura, mehurji, konjunktivitis, angioedem, zvišani rezultati testov jetrne funkcije in/ali eozinofilija.
Rilpivirine is primarily metabolised by CYP3A Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Zato lahko zdravila, ki inducirajo ali zavirajo CYP3A, vplivajo na očistek rilpivirina (glejte poglavje 5.2).
• St. John's wort (Hypericum perforatum)
(Hypericum perforatum)
Darunavir (800 mg once daily)/ Ritonavir (100 mg once daily)/ Rilpivirine1
darunavir (800 mg enkrat dnevno)/ritonavir (100 mg enkrat dnevno)/rilpivirin1
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 Med primarno analizo v 48. tednu in 96. tednom se je pojavilo 10 novih viroloških neuspehov (3 bolniki z začetno virusno obremenitvijo ≤ 100.000 kopij/ml in 7 bolnikov z začetno virusno obremenitvijo > 100.000 kopij/ml).
Stayed on Baseline Regimen (SBR) arm n = 159
Krak z ohranitvijo začetnega režima n = 159
Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Polysorbate 20
Jedro tablete premreženi natrijev karmelozat laktoza monohidrat magnezijev stearat mikrokristalna celuloza polisorbat 20 povidon predgelirani koruzni škrob
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 pokazal protiretrovirusno aktivnost v celični kulturi proti podtipom A, B, C, D, E, F, in G virusa HIV-1 (vrednosti EC50 so bile v razponu od 0,007 do 0,075 µM) in aktivnost, specifično za sev, proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,007 do 1,5 µM).
ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
karbamazepin okskarbazepin fenobarbital fenitoin
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera (see section 4.4).
Verjetnost, da je ledvična funkcija pri bolnikih starostnikih zmanjšana, je večja, zato je pri zdravljenju bolnikov starostnikov z zdravilom Eviplera potrebna previdnost (glejte poglavje 4.4).
Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Rilpivirin je in vitro zaviralec prenašalca MATE-2K z IC50 < 2,7 nM. Klinična implikacija tega izsledka trenutno ni znana.
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).
Verjetnost, da je ledvična funkcija pri bolnikih starostnikih zmanjšana, je večja, zato je pri zdravljenju bolnikov starostnikov z zdravilom Eviplera potrebna previdnost (glejte poglavji 4.2 in 5.2).
No dose adjustment is required for rilpivirine hydrochloride in patients with mild or moderate hepatic impairment (CPT Score A or B).
Prilagoditev odmerka za rilpivirinijev klorid ni potrebna pri bolnikih z blago do zmerno jetrno okvaro (stopnje A ali B po CPT).
Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Rilpivirine1 (soft capsule)
lopinavir (400 mg dvakrat dnevno)/ritonavir (100 mg dvakrat dnevno)/rilpivirin1 (mehka kapsula)
In general, emtricitabine pharmacokinetics in HBV infected patients was similar to those in healthy subjects and in HIV infected patients.
Sočasna okužba z virusom hepatitisa B in/ali hepatitisa C Na splošno so bile farmakokinetične lastnoti emtricitabina pri bolnikih, okuženih z virusom HBV zelo podobne tistim pri zdravih osebah in bolnikih, okuženih z virusom HIV.
Do not breast-feed during treatment with Eviplera:
Med zdravljenjem z zdravilom Eviplera ne dojite.
Paracetamol (500 mg single dose)/ Rilpivirine1
paracetamol (enkratni odmerek 500 mg)/rilpivirin1
Herpesvirus antiviral agents Famciclovir/Emtricitabine
Protivirusna zdravila proti virusom skupine herpes famciklovir/emtricitabin famciklovir:
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Varnost in učinkovitost zdravila Eviplera nista bili ugotavljani pri zdravljenju kronične okužbe z virusom HBV. Emtricitabin in tenofovir sta v študijah farmakodinamike posamično in v kombinaciji pokazala aktivnost proti virusu HBV (glejte poglavje 5.1).
• Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).
• emtricitabin, zaviralec nukleozidne reverzne transkriptaze (NRTI)
Eviplera has not been studied in patients with severe hepatic impairment (CPT Score C).
Zdravila Eviplera niso preučili pri bolnikih s hudo jetrno okvaro (stopnje C po CPT).
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.
V 96. tednu je bila v združenih študijah faze III C209 in C215 predhodno nezdravljenih bolnikov v kraku z rilpivirinom povprečna sprememba od začetne vrednosti za skupni holesterol (na tešče) 5 mg/dl, za holesterol lipoproteinov velike gostote (HDL, high-density lipoprotein) (na tešče) 4 mg/dl, za holesterol lipoproteinov majhne gostote (LDL, low density lipoprotein) (na tešče) 1 mg/dl in za trigliceride (na tešče) −7 mg/dl.
Antifungals Ketoconazole/Emtricitabine
Antimikotiki ketokonazol/emtricitabin
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).
Opazili so, da sočasna uporaba zdravila Eviplera z zaviralci protonske črpalke povzroči zmanjšane koncentracije rilpivirina v plazmi (zaradi povečanja vrednosti pH v želodcu) kar lahko vodi do zmanjšanja terapevtskega učinka zdravila Eviplera (glejte poglavje 4.3).
• Lactic acidosis (see Possible side effects: tell a doctor immediately)
Redki:pojavijo se lahko pri največ 1 od 1.000 bolnikov • laktacidoza (glejte Možni neželeni učinki; takoj obvestite zdravnika)
GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
deksametazon (sistemski, razen v obliki enkratnega odmerka)
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.
Pri bolnikih z normalno ledvično funkcijo s srednjo vrednostjo (% koeficienta variacije) izpostavljenosti emtricitabinu 12 (25 %) µg•h/ml se je le-ta pri bolnikih z blago ledvično okvaro zvišala na 20 (6 %) µg•h/ml, pri bolnikih z zmerno ledvično okvaro na 25 (23 %) µg•h/ml in na 34 (6 %) µg•h/ml pri bolnikih s hudo ledvično okvaro.
Didanosine The co-administration of Eviplera and didanosine is not recommended (see section 4.4 and Table 1).
Sočasna uporaba zdravila Eviplera in didanozina ni priporočljiva (glejte poglavje 4.4 in preglednico 1).
The following may be signs of lactic acidosis:
Znaki laktacidoze so lahko:
Concomitant use contraindicated
Sočasna uporaba z drugimi zdravili je kontraindicirana
Antacids should only be administered either at least 2 hours before or at least 4 hours after Eviplera.
Antacide je treba dati bodisi vsaj 2 uri pred uporabo zdravila Eviplera ali vsaj 4 ure po njej.
Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Sočasni uporabi zdravila Eviplera z nefrotoksičnimi zdravili ali uporabi kmalu za njimi se je treba izogibati (glejte poglavje 4.5).
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.
Pri bolnikih z normalno ledvično funkcijo s srednjo vrednostjo (% koeficienta variacije) izpostavljenosti tenofovirju 2.185 (12 %) ng•h/ml se je le-ta pri bolnikih z blago ledvično okvaro zvišala na 3.064 (30 %) ng•h/ml, pri bolnikih z zmerno ledvično okvaro na 6.009 (42 %) ng•h/ml in na 15.985 (45 %) ng•h/ml pri bolnikih s hudo ledvično okvaro.
• the systemic glucocorticoid dexamethasone, except as a single dose treatment
• sistemski glukokortikoid deksametazon, razen v obliki zdravljenja z enkratnim odmerkom • šentjanževka (Hypericum perforatum)
More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Rezistenca, povezana z lamivudinom/emtricitabinom, se je pojavila pri več bolnikih z virološkim neuspehom na zdravilo rilpivirin, kot pri bolnikih z virološkim neuspehom na efavirenz (glejte poglavje 5.1).
Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Zato se uporaba zdravila Eviplera pri bolnikih s hudo jetrno okvaro ne priporoča (glejte poglavji 4.4 in 5.2).
Raltegravir/Rilpivirine
raltegravir/rilpivirin raltegravir:
Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).
Ena filmsko obložena tableta vsebuje 200 mg emtricitabina, 25 mg rilpivirina (v obliki klorida) in 245 mg dizoproksiltenofovirata (v obliki fumarata).
Simeprevir: AUC: ↔ Cmax: ↑ 10%
simeprevir: AUC: ↔ Cmax: ↑ 10 % Cmin: ↔