FrancophonIA/ELRC3.0 huggingface dataset:
English: Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Rilpivirine1 (soft capsule)
Slovenian: lopinavir (400 mg dvakrat dnevno)/ritonavir (100 mg dvakrat dnevno)/rilpivirin1 (mehka kapsula)
English: In general, emtricitabine pharmacokinetics in HBV infected patients was similar to those in healthy subjects and in HIV infected patients.
Slovenian: 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.
English: Do not breast-feed during treatment with Eviplera:
Slovenian: Med zdravljenjem z zdravilom Eviplera ne dojite.
English: Paracetamol (500 mg single dose)/ Rilpivirine1
Slovenian: paracetamol (enkratni odmerek 500 mg)/rilpivirin1
English: Omeprazole:
Slovenian: omeprazol:
English: Herpesvirus antiviral agents Famciclovir/Emtricitabine
Slovenian: Protivirusna zdravila proti virusom skupine herpes famciklovir/emtricitabin famciklovir:
English: Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Slovenian: 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).
English: • Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).
Slovenian: • emtricitabin, zaviralec nukleozidne reverzne transkriptaze (NRTI)
English: Eviplera has not been studied in patients with severe hepatic impairment (CPT Score C).
Slovenian: Zdravila Eviplera niso preučili pri bolnikih s hudo jetrno okvaro (stopnje C po CPT).
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.
Slovenian: 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.
English: Antifungals Ketoconazole/Emtricitabine
Slovenian: Antimikotiki ketokonazol/emtricitabin
English: 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).
Slovenian: 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).
English: • Lactic acidosis (see Possible side effects: tell a doctor immediately)
Slovenian: Redki:pojavijo se lahko pri največ 1 od 1.000 bolnikov • laktacidoza (glejte Možni neželeni učinki; takoj obvestite zdravnika)
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Slovenian: deksametazon (sistemski, razen v obliki enkratnega odmerka)
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.
Slovenian: 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.
English: Didanosine The co-administration of Eviplera and didanosine is not recommended (see section 4.4 and Table 1).
Slovenian: Sočasna uporaba zdravila Eviplera in didanozina ni priporočljiva (glejte poglavje 4.4 in preglednico 1).
English: The following may be signs of lactic acidosis:
Slovenian: Znaki laktacidoze so lahko:
English: Concomitant use contraindicated
Slovenian: Sočasna uporaba z drugimi zdravili je kontraindicirana
English: Antacids should only be administered either at least 2 hours before or at least 4 hours after Eviplera.
Slovenian: Antacide je treba dati bodisi vsaj 2 uri pred uporabo zdravila Eviplera ali vsaj 4 ure po njej.
English: Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Slovenian: Sočasni uporabi zdravila Eviplera z nefrotoksičnimi zdravili ali uporabi kmalu za njimi se je treba izogibati (glejte poglavje 4.5).
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.
Slovenian: 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.
English: • the systemic glucocorticoid dexamethasone, except as a single dose treatment
Slovenian: • sistemski glukokortikoid deksametazon, razen v obliki zdravljenja z enkratnim odmerkom • šentjanževka (Hypericum perforatum)
English: More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Slovenian: 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).
English: Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Zato se uporaba zdravila Eviplera pri bolnikih s hudo jetrno okvaro ne priporoča (glejte poglavji 4.4 in 5.2).
English: Raltegravir/Rilpivirine
Slovenian: raltegravir/rilpivirin raltegravir:
English: Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).
Slovenian: Ena filmsko obložena tableta vsebuje 200 mg emtricitabina, 25 mg rilpivirina (v obliki klorida) in 245 mg dizoproksiltenofovirata (v obliki fumarata).
English: 25-O-desacetyl-rifabutin:
Slovenian: 25-O-dezacetil-rifabutin: AUC: ↔
English: Simeprevir: AUC: ↔ Cmax: ↑ 10%
Slovenian: simeprevir: AUC: ↔ Cmax: ↑ 10 % Cmin: ↔
English: • The active substances are emtricitabine, rilpivirine and tenofovir disoproxil.
Slovenian: • Učinkovine so emtricitabin, rilpivirin in dizoproksiltenofovirat.
English: No dose adjustments are required when initiating co-administration of methadone with Eviplera.
Slovenian: Pri uvedbi sočasnega dajanja metadona z zdravilom Eviplera odmerka ni treba prilagajati.
English: • Pain in the abdomen (tummy) caused by inflammation of the pancreas
Slovenian: • bolečine v trebuhu zaradi vnetja pankreasa
English: Other antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Slovenian: Druga protiretrovirusna zdravila ledipasvir/sofosbuvir (90 mg/400 mg enkrat dnevno)/emtricitabin/rilpivirin/ dizoproksiltenofovirat (200 mg/25 mg/245 mg enkrat dnevno)
English: Co-administration of Eviplera with medicinal products that inhibit CYP3A enzyme activity has been observed to increase rilpivirine plasma concentrations.
Slovenian: Opazili so, da sočasna uporaba zdravila Eviplera z zdravili, ki zavirajo aktivnost encima CYP3A, povzroči povečane koncentracije rilpivirina v plazmi.
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.
Slovenian: b Razlika stopnje odziva je 1 % (95-odstotni interval zaupanja −3 % do 6 %) z normalnim približanjem.
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Slovenian: Če je ustrezno, se lahko ponovno uvede zdravljenje hepatitisa B. Pri bolnikih z napredovalo boleznijo jeter ali cirozo prekinitev zdravljenja ni priporočljiva, saj poslabšanja hepatitisa po zdravljenju lahko povzročijo jetrno dekompenzacijo.
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin/Emtricitabine
Slovenian: ZAVIRALCI REDUKTAZE HMG CoA
English: • Rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
Slovenian: • izpuščaji (vključno z rdečimi pikami ali ogrci, včasih z mehurjasto in oteklo kožo), kar je lahko alergična reakcija, srbečica, sprememba obarvanosti kože, vključujoč temne lise
English: Raltegravir (400 mg twice daily)/ Tenofovir disoproxil
Slovenian: raltegravir (400 mg dvakrat dnevno)/dizoproksiltenofovirat raltegravir:
English: The combination of Eviplera and H2-receptor antagonists should be used with particular caution as co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH).
Slovenian: Kombinacijo zdravila Eviplera in antagonistov receptorjev H2 je treba uporabljati previdno, saj lahko sočasna uporaba povzroči pomembno zmanjšanje koncentracij rilpivirina v plazmi (zmanjšana absorpcija, povečanje pH vrednosti v želodcu).
English: Interaction not studied with Eviplera.
Slovenian: Interakcij z zdravilom Eviplera niso preučevali.
English: Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Slovenian: Sočasni uporabi zdravila Eviplera z nefrotoksičnimi zdravili ali uporabi kmalu za njimi se je treba izogibati.
English: ORAL CONTRACEPTIVES Ethinylestradiol/Norethindrone/ Emtricitabine
Slovenian: etinilestradiol/noretindron/ emtricitabin
English: Esomeprazole2
Slovenian: esomeprazol2
English: An increased risk of adverse reactions associated with Eviplera and its individual components may be seen in the event of an overdose.
Slovenian: V primeru prevelikega odmerka se lahko pojavi večje tveganje za neželene učinke, povezane z zdravilom Eviplera in njegovimi posameznimi sestavinami.
English: Rifabutin (300 mg once daily)/ Rilpivirine3
Slovenian: rifabutin (300 mg enkrat dnevno)/rilpivirin3
English: Virologically suppressed HIV-1 infected patients
Slovenian: Bolniki z virološko supresijo, okuženi z virusom HIV-1
English: In patients with BL VL1 ≤ 100,000 copies/mL (n = 22)
Slovenian: Pri bolnikih z začetno virusno obremenitvijo ≤ 100.000 kopij/ml
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Slovenian: sofosbuvir/velpatasvir (400 mg/100 mg enkrat dnevno)/ emtricitabin/rilpivirin/dizoproksiltenofovirat (200 mg/25 mg/245 mg enkrat dnevno)
English: No dose adjustment is required following the switch from an efavirenz-containing regimen.
Slovenian: Po prehodu z režima, ki vsebuje efavirenz, odmerka ni potrebno prilagoditi.
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).
Slovenian: Ena filmsko obložena tableta zdravila Eviplera vsebuje 200 mg emtricitabina, 25 mg rilpivirina (v obliki klorida) in 245 mg dizoproksiltenofovirata (v obliki fumarata).
English: The combination of Eviplera with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Slovenian: Kombinacija zdravila Eviplera s temi makrolidnimi antibiotiki lahko povzroči povečanje koncentracij rilpivirina v plazmi (zaviranje encimov 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).
Slovenian: Ni verjetno, da bi bilo pri bolnikih z blago ali zmerno jetrno okvaro potrebno odmerek zdravila Eviplera prilagoditi (glejte poglavji 4.2 in 5.2).
English: Table 5: Virologic outcomes of randomised treatment of studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 48 (primary) and week 96
Slovenian: Preglednica 5: Virološki izidi randomiziranega zdravljenja v študijah C209 in C215 (združeni podatki za bolnike, ki so prejemali rilpivirinijev klorid ali efavirenz v kombinaciji z emtricitabinom/dizoproksiltenofoviratom) v 48. tednu (primarna) in v 96. tednu
English: ANALGESICS Paracetamol/Emtricitabine
Slovenian: paracetamol/emtricitabin
English: Eviplera should not be administered concomitantly with adefovir dipivoxil.
Slovenian: Zdravila Eviplera se ne sme sočasno uporabljati z dipivoksiladefoviratom.
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).
Slovenian: Zdravila Eviplera se ne sme uporabljati v kombinaciji s sistemskim deksametazonom (razen v obliki enkratnega odmerka), saj lahko sočasna uporaba povzroči pomembno, od odmerka odvisno zmanjšanje koncentracij rilpivirina v plazmi (indukcija encimov CYP3A).
English: Laboratory abnormalities
Slovenian: Nenormalni rezultati laboratorijskih preiskav
English: Cytochrome P450 enzyme inhibitors
Slovenian: Zaviralci encima citokrom P450
English: If you have a history of liver disease, or chronic hepatitis B infection, your doctor may conduct blood tests in order to monitor liver function.
Slovenian: Dve učinkovini v zdravilu Eviplera (dizoproksiltenofovirat in emtricitabin) kažeta zmerno aktivnost proti virusu hepatitisa B. Če imate jetrne bolezni v anamnezi ali kronični hepatitis B, bo zdravnik morda naredil krvne preiskave, da bo nadzoroval delovanje vaših jeter.
English: Very common: increased pancreatic amylase2, vomiting1, 2, 3, diarrhoea1, 3, nausea1, 2, 3
Slovenian: zvišanje pankreasne amilaze2, bruhanje1, 2, 3, driska1, 3, navzea1, 2, 3
English: Mean percent change in AUC,
Slovenian: Učinkovine po terapevtskih področjih Učinki na koncentracije učinkovin Srednja sprememba AUC,
English: Sofosbuvir/Tenofovir disoproxil
Slovenian: sofosbuvir/dizoproksiltenofovirat
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
Slovenian: Preglednica 4: Demografske in začetne značilnosti odraslih bolnikov, okuženih z virusom HIV-1, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, v študijah C209 in C215 (združeni podatki za bolnike, ki so prejemali rilpivirinijev klorid ali efavirenz v kombinaciji z emtricitabinom/dizoproksiltenofoviratom) v 96. tednu
English: In patients with BL VL1 > 100,000 copies/mL (n = 44)
Slovenian: Pri bolnikih z začetno virusno obremenitvijo > 100.000 kopij/ml
English: The most common emergent resistance mutations in Eviplera-treated patients were M184V/I and E138K in RT. All patients remained susceptible to tenofovir.
Slovenian: Najpogostejši mutaciji rezistence, nastali med zdravljenjem, pri bolnikih, zdravljenih z zdravilom Eviplera, sta bili M184V/I in E138K pri RT.
English: ANTI-INFECTIVES
Slovenian: ANTIDIABETIKI
English: AUC: ↔ Cmin: ↓ 15% Cmax: ↑ 35%
Slovenian: atorvastatin: AUC: ↔ Cmin: ↓ 15 % Cmax: ↑ 35 %
English: No dose adjustment of Eviplera is required in patients with mild or moderate hepatic impairment.
Slovenian: Odmerka zdravila Eviplera ni treba prilagoditi pri bolnikih z blago ali zmerno jetrno okvaro.
English: Steady-state administration of rilpivirine hydrochloride 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively,
Slovenian: Dajanje rilpivirinijevega klorida 75 mg enkrat dnevno in 300 mg enkrat dnevno v stanju dinamičnega ravnovesja je povzročilo približno 2,6-krat oziroma 6,7-krat večji povprečni Cmax odpovprečnega Cmax v stanju dinamičnega ravnovesja, ki so ga opazili s priporočenim odmerkom 25 mg rilpivirinijevega klorida enkrat dnevno.
English: Eviplera should not be administered concomitantly with adefovir dipivoxil (see section 4.5).
Slovenian: Zdravila Eviplera se ne sme sočasno uporabljati z dipivoksiladefoviratom (glejte poglavje 4.5).
English: AUC: ↑ 16%* Cmin: ↔* Cmax: ↑ 43%*
Slovenian: AUC: ↑ 16 %* Cmin: ↔*
English: N/A = not applicable
Slovenian: (n = 44)
English: Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Slovenian: Verjetno je, da bo sočasna uporaba povzročila pomembno zmanjšanje koncentracij rilpivirina v plazmi (indukcija encimov CYP3A).
English: You must remain under the care of your doctor while taking Eviplera.
Slovenian: Pri jemanju zdravila Eviplera morate ostati v zdravniški oskrbi.
English: Paracetamol/Tenofovir disoproxil
Slovenian: paracetamol/dizoproksiltenofovirat
English: Rifampicin (600 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Slovenian: rifampicin (600 mg enkrat dnevno)/dizoproksiltenofovirat (245 mg enkrat dnevno)
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg + 100 mg once daily)5/ Rilpivirine/Emtricitabine (25 mg/200 mg once daily)6
Slovenian: Priporočilo glede sočasne uporabe z zdravilom Eviplera sofosbuvir/velpatasvir/ voksilaprevir (400 mg/100 mg/ 100 mg + 100 mg enkrat dnevno)5/ rilpivirin/emtricitabin (25 mg/200 mg enkrat dnevno)6
English: AUC: ↑ 49% C12h: ↑ 3% Cmax: ↑ 64%
Slovenian: AUC: ↑ 49 % C12h: ↑ 3 %
English: Indigo carmine aluminium lake Lactose monohydrate Polyethylene glycol Red iron oxide
Slovenian: Filmska obloga hipromeloza barvilo indigotin laktoza monohidrat polietilen glikol rdeč železov oksid barvilo sončno rumeno FCF (E110) titanov dioksid triacetin
English: How to store Eviplera
Slovenian: Shranjevanje zdravila Eviplera
English: Rifampicin (600 mg once daily)/ Rilpivirine1
Slovenian: rifampicin (600 mg enkrat dnevno)/rilpivirin1
English: Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Slovenian: famotidin (40 mg enkratni odmerek, vzet 12 ur pred rilpivirinom)/ rilpivirin1
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).
Slovenian: Zdravila Eviplera se ne sme uporabljati v kombinaciji z zaviralci protonske črpalke, saj je verjetno, da bo sočasna uporaba povzročila pomembno zmanjšanje koncentracij rilpivirina v plazmi (zmanjšana absorpcija, povečanje pH vrednosti v želodcu).
English: Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV.
Slovenian: Za optimalno zdravljenje okužbe z virusom HIV pri bolnikih, ki so hkrati okuženi s HBV, naj zdravniki upoštevajo trenutno veljavne smernice za zdravljenje HIV.
English: Atorvastatin (40 mg once daily)/ Rilpivirine1
Slovenian: atorvastatin (40 mg enkrat dnevno)/rilpivirin1
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil/Emtricitabine
Slovenian: ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE5)
English: Eviplera must not be used in combination with products containing St. John's wort as coadministration may cause significant decreases in rilpivirine plasma concentrations.
Slovenian: Zdravila Eviplera ni dovoljeno uporabljati v kombinaciji z zdravili, ki vsebujejo šentjanževko, saj lahko sočasna uporaba povzroči pomembno zmanjšanje koncentracij rilpivirina v plazmi.
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.
Slovenian: Predklinični podatki za rilpivirinijev klorid na osnovi študij farmakološke varnosti, izpostavljenosti zdravilu, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Slovenian: sofosbuvir (400 mg enkrat dnevno)/rilpivirin (25 mg enkrat dnevno)
English: 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.
Slovenian: Predklinični podatki o emtricitabinu na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
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).
Slovenian: Kombinacijo zdravila Eviplera in antiacidov je treba uporabljati previdno, saj lahko sočasna uporaba povzroči pomembno zmanjšanje koncentracij rilpivirina v plazmi (zmanjšana absorpcija, povečanje pH vrednosti v želodcu).
English: Omeprazole (20 mg once daily)/ Rilpivirine1
Slovenian: omeprazol (20 mg enkrat dnevno)/rilpivirin1
English: Medicinal product by therapeutic areas
Slovenian: ZDRAVILA RASTLINSKEGA IZVORA
English: Integrase strand transfer inhibitors Raltegravir/Emtricitabine
Slovenian: Zaviralci integraze, ki zavirajo vstavljanje DNK virusa HIV raltegravir/emtricitabin
English: • Feeling sick (nausea), being sick (vomiting)
Slovenian: • občutek siljenja na bruhanje (navzea), bruhanje
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).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic je treba prilagoditi interval odmerka emtricitabina in dizoproksiltenofovirata, česar ni mogoče doseči s kombinirano tableto (glejte poglavji 4.2 in 4.4).
English: Liver toxicity associated with liver enzyme induction was observed in rodents.
Slovenian: Pri glodavcih so opazili toksičen vpliv na jetra, povezan z induciranjem jetrnega encima.
English: Antimycobacterials Rifabutin/Emtricitabine
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami rifabutin/emtricitabin
English: Inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported rarely when medicines containing tenofovir disoproxil and didanosine were taken together.
Slovenian: Pri sočasnem jemanju zdravil, ki vsebujejo dizoproksiltenofovirat in didanozin, so redko poročali o vnetju trebušne slinavke in laktoacidozi (preveč mlečne kisline v krvi), ki je bila včasih smrtna.
English: Didanosine (400 mg once daily)/ Rilpivirine1
Slovenian: didanozin(400 mg enkrat dnevno)/rilpivirin1