FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of sofosbuvir/velpatasvir and efavirenz is expected to decrease plasma concentrations of velpatasvir.
Slovenian: Pri sočasni uporabi sofosbuvirja/velpatasvirja in efavirenza se pričakuje zmanjšanje koncentracije velpatasvirja v plazmi.
English: 2 years Bottle pack: Use within 90 days after first opening
Slovenian: 2 leti Pakiranje s plastenko: Po prvem odprtju porabiti v 90 dneh.
English: • The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil/efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine+tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
Slovenian: • se je mutacija M184V/I razvila pri 2/19 (10,5 %) izolatov, ki so jih analizirali pri bolnikih v skupini, ki je prejemala emtricitabin/dizoproksiltenofovirat/efavirenz, in pri 10/29 (34,5 %) izolatov, analiziranih pri skupini, ki je prejemala lamivudin/zidovudin/efavirenz (vrednost p < 0,05, Fisherjev test, ki je skupino z emtricitabinom in dizoproksiltenofoviratom primerjal s skupino z lamivudinom/zidovudinom pri vseh bolnikih);
English: If Emtricitabine/Tenofovir disoproxil Mylan is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule
Slovenian: Če se zdravilo Emtricitabin/dizoproksiltenofovirat Mylan uporabljate skupaj z nefrotoksičnimi zdravili, je treba delovanje ledvic skrbno spremljati po priporočenem urniku;
English: In a randomised clinical study (M02-418), 190 antiretroviral-naïve adults were treated once daily with emtricitabine and tenofovir disoproxil in combination with lopinavir/ritonavir given once or twice daily.
Slovenian: V randomizirani klinični študiji (M02-418) so 190 odraslih, ki še niso bili zdravljeni s protiretrovirusnim zdravilom, enkrat dnevno zdravili z emtricitabinom in dizoproksiltenofoviratom v kombinaciji z lopinavirjem/ritonavirjem enkrat ali dvakrat na dan.
English: The pharmacokinetics of tenofovir (administered as tenofovir disoproxil) have not been specifically studied in different ethnic groups.
Slovenian: Farmakokinetike tenofovirja (uporabljenega v obliki dizoproksiltenofovirata) niso posebej preučevali pri različnih etničnih skupinah.
English: Serum Herpes Simplex Virus Type 2 Infection, N (%) Urine Leukocyte Esterase Positive, N (%)
Slovenian: Serumska okužba z virusom herpes simpleks tipa 2, N (%)
English: A subgroup of patients with baseline creatinine clearance between 50 and 60 mL/min, receiving once daily dosing, had a 2-4-fold increase in tenofovir exposure and worsening renal function.
Slovenian: Podskupina bolnikov z začetno vrednostjo očistka kreatinina med 50 in 60 ml/min, ki so ji zdravilo odmerjali enkrat dnevno, je imela 2-4-kratno povečanje izpostavljenosti tenofovirju in poslabšanje delovanja ledvic.
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to initiating emtricitabine/tenofovir disoproxil for treatment of HIV-1 or for pre-exposure prophylaxis, and should be monitored during use as in adults (see above).
Slovenian: Ledvično funkcijo (očistek kreatinina in serumski fosfat) je treba pred uvedbo emtricitabina/dizoproksiltenofovirata za zdravljenje okužbe s HIV-1 ali zaščite pred izpostavitvijo ovrednotiti, nato pa jo je treba med uporabo spremljati kot pri odraslih osebah (glejte zgoraj).
English: The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 mL/min; mild impairment with CrCl = 50-79 mL/min; moderate impairment with CrCl = 30-49 mL/min and severe impairment with CrCl = 10-29 mL/min).
Slovenian: Stopnja ledvične okvare je bila določena glede na začetno vrednost očistka kreatinina (ClCr) (normalna ledvična funkcija je pri ClCr > 80 ml/min; blaga ledvična okvara pri ClCr = 50-79 ml/min; zmerna ledvična okvara pri ClCr = 30-49 ml/min in huda ledvična okvara pri ClCr = 10-29 ml/min).
English: 2 The predominant circulating metabolite of sofosbuvir.
Slovenian: 2 Prevladujoči presnovek sofosbuvirja v obtoku.
English: Furthermore, in a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 mL/min who received tenofovir disoproxil in combination with emtricitabine every 24 hours had a 2-4-fold higher exposure to tenofovir and worsening of renal function (see section 5.2).
Slovenian: Nadalje je imela v majhni klinični študiji podskupina bolnikov z očistkom kreatinina med 50 in 60 ml/min, ki je prejemala dizoproksiltenofovirat v kombinaciji z emtricitabinom vsakih 24 ur, 2-4-krat večjo izpostavljenost tenofovirju in poslabšanje delovanja ledvic (glejte poglavje 5.2).
English: • feeling weak
Slovenian: • občutek oslabelosti
English: A light green, film-coated, capsule shaped, biconvex tablet, of dimensions 19.80 mm x 9.00 mm, debossed with ‘M' on one side of the tablet and ‘ETD' on the other side
Slovenian: Svetlo zelena, bikonveksna, filmsko obložena tableta kapsulne oblike, z dimenzijami 19,80 mm x 9,00 mm, z vtisnjenima oznako ''M'' na eni strani in ''ETD'' na drugi strani.
English: • pentamidine (for infections)
Slovenian: • pentamidin (za okužbe)
English: Tenofovir pharmacokinetics were not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment is required in these subjects.
Slovenian: Farmakokinetika tenofovirja se pri osebah z jetrno okvaro ni bistveno spremenila, kar nakazuje, da pri teh osebah ni potrebno prilagoditi odmerjanja.
English: • increased creatine kinase Common side effects
Slovenian: • povišanje kreatin-kinaze Pogosti neželeni učinki
English: 9% (2% to 17%)
Slovenian: 9 % (2 % do 17 %)
English: The safety and efficacy of emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis in patients with HBV or HCV infection has not been established.
Slovenian: Varnost in učinkovitost emtricitabina/dizoproksiltenofovirata za zaščito pred izpostavitvijo pri bolnikih z okužbo s HBV ali HCV nista bili ugotovljeni.
English: Baseline characteristics are summarised in Table 8.
Slovenian: Značilnosti populacije v izhodišču so povzete v preglednici 8.
English: Patients with HIV-1 harbouring mutations
Slovenian: Bolniki, okuženi s HIV-1, ki so nosilci mutacij
English: Missing doses may increase your risk of getting HIV infection.
Slovenian: Izpuščeni odmerki lahko povečajo tveganje za okužbo s HIV.
English: In study GS US 104 0352, 89 HIV-1 infected paediatric patients with a median age of 7 years (range 2 to 15 years) were exposed to tenofovir disoproxil for a median of 331 weeks.
Slovenian: V študiji GS-US-104-0352 je bilo 89 pediatričnih bolnikov, okuženih s HIV-1, z mediano starosti 7 let (razpon od 2 do 15 let) izpostavljenih dizoproksiltenofoviratu za mediano obdobje 331 tednov.
English: Overall HIV-1 infection prevention strategy
Slovenian: Splošna strategija za preprečevanje okužbe s HIV-1
English: Emtricitabine/tenofovir disoproxil should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during emtricitabine/tenofovir disoproxil therapy.
Slovenian: Emtricitabina/dizoproksiltenofovirata ni dovoljeno uvesti pri pediatričnih bolnikih z ledvično okvaro, pri bolnikih, pri katerih se med zdravljenjem z emtricitabinom/dizoproksiltenofoviratom razvije ledvična okvara, pa je treba uporabo prekiniti.
English: Table 3: Tabulated summary of adverse reactions associated with the individual components of emtricitabine/tenofovir disoproxil based on clinical study and post-marketing experience
Slovenian: Preglednica 3: Povzetek neželenih učinkov, povezanih s posameznima učinkovinama emtricitabina/dizoproksiltenofovirata na podlagi izkušenj iz kliničnih študij in izkušenj v obdobju trženja zdravila
English: In 3 of 10 subjects who had acute HIV infection at study enrolment, M184I and M184V mutations were detected in the HIV of 2 of 2 subjects in the emtricitabine/tenofovir disoproxil group and 1 of 8 subjects in the placebo group.
Slovenian: Pri 3 od 10 oseb, ki so imele akutno okužbo s HIV v času vključitve v študijo, so bile mutacije M184I in M184V v virusu HIV odkrite pri 2 od 2 oseb v skupini, ki je prejemala emtricitabin/dizoproksiltenofovirat, in pri 1 od 8 oseb v skupini, ki je prejemala placebo.
English: • Whenever possible, Emtricitabine/Tenofovir disoproxil Mylan should be taken with food.
Slovenian: • Kadar je mogoče, je treba zdravilo Emtricitabin/dizoproksiltenofovirat Mylan jemati s hrano.
English: * Patients receiving emtricitabine, tenofovir disoproxil and efavirenz were given emtricitabine/tenofovir disoproxil plus efavirenz from week 96 to 144.
Slovenian: * Bolniki, ki so prejemali emtricitabin, dizoproksiltenofovirat in efavirenz, so dobivali emtricitabin/dizoproksiltenofovirat in efavirenz od 96. do 144. tedna.
English: 30 film-coated tablets 30 x 1 film-coated tablets (unit pack) 90 x 1 film-coated tablets (unit pack) 100 x 1 film-coated tablets (unit pack)
Slovenian: 30 x 1 filmsko obložena tableta (pakiranje za posamezni odmerek) 90 x 1 filmsko obložena tableta (pakiranje za posamezni odmerek) 100 x 1 filmsko obložena tableta (pakiranje za posamezni odmerek)
English: Herpes virus antiviral agents Famciclovir/Emtricitabine
Slovenian: Protivirusna zdravila za zdravljenje virusa herpesa famciklovir/emtricitabin famciklovir:
English: Assessment of adverse reactions related to emtricitabine is based on experience in three paediatric studies (n = 169) where treatment-naïve (n = 123) and treatment-experienced (n = 46) paediatric HIV infected patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
Slovenian: Ocena neželenih učinkov, povezanih z emtricitabinom, temelji na izkušnjah iz treh pediatričnih študij (n = 169) s predhodno nezdravljenimi (n = 123) in predhodno zdravljenimi (n = 46) pediatričnimi bolniki, okuženimi s HIV, starimi od 4 mesece do 18 let, ki so se zdravili z emtricitabinom v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: However, individuals should be informed that dizziness has been reported during treatment with both emtricitabine and tenofovir disoproxil.
Slovenian: Posameznike je kljub temu potrebno opozoriti, da se lahko v času zdravljenja z emtricitabinom in dizoproksiltenofoviratom pojavi omotičnost.
English: If a dose of emtricitabine/tenofovir disoproxil is missed within 12 hours of the time it is usually taken, emtricitabine/tenofovir disoproxil should be taken as soon as possible and the normal dosing schedule should be resumed.
Slovenian: Če se izpusti odmerek emtricitabina/dizoproksiltenofovirata v roku 12 ur od časa, ko se ga običajno vzame, je treba vzeti emtricitabin/dizoproksiltenofovirat takoj, ko je mogoče, nato pa nadaljevati z običajnim režimom odmerjanja.
English: Animal studies on emtricitabine and tenofovir disoproxil do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije emtricitabina in dizoproksiltenofovirata na živalih ne kažejo vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: Poročajo o avtoimunskih boleznih (kot je Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
English: Close monitoring of renal function is required in these patients (see section 4.5).
Slovenian: Pri teh bolnikih je treba ledvično funkcijo skrbno spremljati (glejte poglavje 4.5).
English: Emtricitabine/tenofovir disoproxil should only be used to reduce the risk of acquiring HIV-1 in individuals confirmed to be HIV negative (see section 4.3).
Slovenian: Emtricitabin/dizoproksiltenofovirat se sme uporabljati le za zmanjševanje tveganja okužbe s HIV-1 pri posameznikih, ki so potrjeno HIV negativni (glejte poglavje 4.3).
English: While taking Emtricitabine/Tenofovir disoproxil Mylan you may still develop infections or other illnesses associated with HIV infection.
Slovenian: Med jemanjem zdravila Emtricitabin/dizoproksiltenofovirat Mylan lahko še vedno pride do okužbe ali drugih bolezni, povezane z okužbo s HIV.
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells
Slovenian: • vnetje ledvic, izločanje večjih količin urina in občutek žeje, ledvična odpoved, okvare celic ledvičnih tubulov
English: Very common:
Slovenian: Zelo pogosto:
English: 13% (4% to 22%)
Slovenian: 13 % (4 % do 22 %)
English: Among 28 patients receiving 96 weeks of treatment with tenofovir disoproxil, BMD Z scores declined by -0.341 for lumbar spine and -0.458 for total body.
Slovenian: Med 28 bolniki, ki so se 96 tednov zdravili z dizoproksiltenofoviratom, se je Z-vrednost MGK zmanjšala za −0,341 za ledveno hrbtenico in −0,458 za celo telo.
English: a Relative risk reduction calculated for mITT cohort based on incident (post-baseline) seroconversion.
Slovenian: a Relativno zmanjšanje tveganja, izračunano za kohorto mITT na osnovi dogodka serokonverzije (po izhodišču študije).
English: Neither emtricitabine nor tenofovir inhibited in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation.
Slovenian: Niti emtricitabin niti tenofovir in vitro nista zavirala presnavljanja zdravil, ki se biotransformirajo s katero koli od pomembnejših izooblik glavnega humanega CYP450.
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Slovenian: Emtricitabin trifosfat in tenofovir difosfat sta šibka zaviralca sesalske DNA-polimeraze in toksičnost za mitohondrije pri in vitro ali in vivo pogojih ni bila dokazana.
English: In vivo treatment of HIV-1: In an open-label randomised clinical study (GS-01-934) in antiretroviral-naïve patients, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/mL at weeks 48, 96 or 144 or at the time of early study drug discontinuation.
Slovenian: Zdravljenje okužbe z virusom HIV-1 in vivo: V odprti, randomizirani klinični študiji (GS-01-934) pri bolnikih, še nezdravljenih s protiretrovirusnimi zdravili, je bila genotipizacija opravljena pri izolatih HIV-1 v plazmi vseh bolnikov s potrjenim HIV RNA > 400 kopij/ml v 48., 96. ali 144. tednu ali ob zgodnji prekinitvi jemanja študijskega zdravila.
English: Limited clinical experience in patients co-infected with HIV and HBV suggests that treatment with emtricitabine or tenofovir disoproxil in antiretroviral combination therapy to control HIV infection results in a reduction in HBV DNA (3 log10 reduction or 4 to 5 log10 reduction, respectively) (see section 4.4).
Slovenian: Majhno število kliničnih izkušenjpri bolnikih, ki so hkrati okuženi z virusom HIV in HBV, kaže, da se zdravljenje z emtricitabinom ali dizoproksiltenofoviratom v kombinirani protiretrovirusni terapiji za nadzorovanje okužbe z virusom HIV odraža tudi v zmanjšanju HBV DNA (zmanjšanje 3 log10 pri emtricitabinu oz. 4 do 5 log10 pri dizoproksiltenofoviratu) (glejte poglavje 4.4).
English: Also contains: lactose monohydrate.
Slovenian: Vsebuje tudi: laktozo monohidrat.
English: • liver and pancreas problems
Slovenian: • težave z jetri in trebušno slinavko
English: Tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R mutation.
Slovenian: Uporabi dizoproksiltenofovirata se je potrebno izogniti pri bolnikih s HIV-1, nosilci mutacije K65R.
English: The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established.
Slovenian: Varnost in učinkovitost emtricitabina/dizoproksiltenofovirata pri otrocih, starih manj kot 12 let, nista bili dokazani.
English: • night sweats
Slovenian: • nočno potenje
English: • Emtricitabine/tenofovir disoproxil may affect your kidneys.
Slovenian: • Emtricitabin/dizoproksiltenofovirat lahko vpliva na ledvice.
English:  If you notice these or any symptoms of inflammation or infection, get medical help immediately.
Slovenian: • palpitacije, tremor ali hiperaktivnost  Če opazite te ali kakršne koli druge simptome vnetja ali okužbe, nemudoma poiščite zdravniško pomoč.
English: The Partners PrEP clinical study (CO-US-104-0380) evaluated emtricitabine/tenofovir disoproxil, tenofovir disoproxil 245 mg, or placebo in 4,758 HIV-uninfected subjects from Kenya or Uganda in serodiscordant heterosexual couples.
Slovenian: Klinična študija Partners PrEP (CO-US-104-0380) je ocenjevala emtricitabin/dizoproksiltenofovirat, dizoproksiltenofovirat 245 mg ali placebo pri 4.758 s HIV neokuženih osebah iz Kenije ali Ugande, ki so bile v serološko neskladnem heteroseksualnem partnerstvu.
English: Emtricitabine/tenofovir disoproxil has not been studied in individuals over the age of 65 years.
Slovenian: Emtricitabina/dizoproksiltenofovirata niso proučevali pri posameznikih, starejših od 65 let.
English: • Just taking this Emtricitabine/Tenofovir disoproxil Mylan may not stop you getting HIV.
Slovenian: • Samo jemanje zdravila Emtricitabin/dizoproksiltenofovirat Mylan morda ne bo preprečilo okužbe s HIV.
English: Patients infected with HIV who also have liver disease (including chronic hepatitis B or C), who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Slovenian: Pri bolnikih s HIV, ki imajo tudi jetrne bolezni (vključno s kroničnim hepatitisom B ali C), ki se zdravijo s protiretrovirusnimi zdravili, obstaja povečano tveganje za pojav hudih jetrnih zapletov, lahko s smrtnim izidom.
English: In 2 of 14 subjects who had acute HIV infection at study enrolment, the K65R mutation was detected in the HIV of 1 of 5 subjects in the tenofovir disoproxil 245 mg group and the M184V mutation (associated with resistance to emtricitabine) was detected in the HIV of 1 of 3 subjects in the emtricitabine/tenofovir disoproxil group.
Slovenian: Pri 2 od 14 oseb, ki so imele akutno okužbo s HIV v času vključitve v študijo, je bila mutacija K65R v virusu HIV odkrita pri 1 od 5 oseb v skupini, ki je prejemala dizoproksiltenofovirat 245 mg, mutacija M184V (povezana z rezistenco na emtricitabin) pa je bila odkrita v virusu HIV pri 1 od 3 oseb v skupini, ki je prejemala emtricitabin/dizoproksiltenofovirat.
English: Cmax: ↓ 24% (↓ 35 to ↓ 11) Cmin: ↔
Slovenian: Cmax: ↓ 24 % (↓ 35 do ↓ 11) Cmin: ↔
English: Emtricitabine: 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: Emtricitabin: 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: Cmin: ↓ 21% (↓ 58 to ↑ 48)
Slovenian: Cmin: ↓ 21 % (↓ 58 do ↑ 48)
English: Relative Risk Reduction (95% CI)b a P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Slovenian: P-vrednosti za URAI se nanašajo na ničelno hipotezo, da se učinkovitost med podskupinama razlikuje (URAI; brez URAI).
English: During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose.
Slovenian: Med zdravljenjem okužbe z virusom HIV se lahko poveča telesna masa ter zveča koncentracija lipidov in glukoze v krvi.
English: Emtricitabine/Tenofovir disoproxil Mylan contains lactose monohydrate.
Slovenian: Zdravilo Emtricitabin/dizoproksiltenofovirat Mylan vsebuje laktozo monohidrat.
English: uninfected individuals should be counselled at frequent intervals to strictly adhere to the recommended Emtricitabine/tenofovir disoproxil daily dosing schedule.
Slovenian: Posamezniki, ki niso okuženi s HIV-1, potrebujejo svetovanje v pogostih intervalih za strogo upoštevanje priporočenega režima dnevnega odmerjanja emtricitabina/dizoprosiltenofovirata.
English: These infections make it easier for HIV to infect you.
Slovenian: Zaradi teh okužb ste bolj dovzetni za okužbo s HIV.
English: Resistance
Slovenian: Rezistenca
English: See also under Co-administration of other medicinal products below.
Slovenian: Glejte tudi poglavje Sočasna uporaba drugih zdravil v nadaljevanju.
English: Co-administration of other medicinal products
Slovenian: Sočasna uporaba drugih zdravil
English: The pharmacokinetics of emtricitabine and tenofovir (administered as tenofovir disoproxil) are expected to be similar in HIV-1 infected and uninfected adolescents based on the similar exposures of emtricitabine and tenofovir in HIV-1 infected adolescents and adults, and the similar exposures of emtricitabine and tenofovir in HIV-1 infected and uninfected adults.
Slovenian: Na podlagi podobne izpostavljenosti emtricitabinu in tenofovirju (uporabljenem v obliki dizoproksiltenofovirata) pri mladostnikih, okuženih s HIV-1, in neokuženih mladostnikih ter podobne izpostavljenosti emtricitabinu in tenofovirju pri mladostnikih, okuženih s HIV-1, in neokuženih odraslih se pričakuje, da bo farmakokinetika emtricitabina in tenofovirja pri mladostnikih, okuženih s HIV-1, in neokuženih mladostnikih podobna.
English: PrEP Checklist for prescribers:
Slovenian: Kontrolni seznam PrEP za predpisujoče zdravnike:
English: Tenofovir exposure achieved in these paediatric patients receiving oral daily doses of tenofovir disoproxil 245 mg or 6.5 mg/kg body weight tenofovir disoproxil up to a maximum dose of 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg. Pharmacokinetic studies have not been performed with tenofovir disoproxil in children under 2 years.
Slovenian: Izpostavljenost tenofovirju, dosežena pri pediatričnih bolnikih, ki so peroralno prejemali dnevne odmerke dizoproksiltenofovirata 245 mg ali 6,5 mg/kg telesne mase dizoproksiltenofovirata do največjega odmerka 245 mg, je bila podobna izpostavljenosti pri odraslih, ki so prejemali odmerke dizoproksiltenofovirata 245 mg enkrat dnevno.
English: Emtricitabine/tenofovir disoproxil alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking emtricitabine/tenofovir disoproxil.
Slovenian: Emtricitabin/dizoproksiltenofovirat sam ne predstavlja celotnega režima za zdravljenje okužbe s HIV-1, pri posameznikih z neodkrito okužbo s HIV-1, ki jemljejo le emtricitabin/dizoproksiltenofovirat, pa so se pojavile mutacije virusa HIV-1, povezane z rezistenco.
English: No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Jetrna okvara: Prilagoditev odmerka ni potrebna pri bolnikih z jetrno okvaro (glejte poglavji 4.4 in 5.2).
English: After oral administration of emtricitabine or tenofovir disoproxil, emtricitabine and tenofovir are widely distributed throughout the body.
Slovenian: Po peroralnem vnosu emtricitabina ali dizoproksiltenofovirata sta emtricitabin in tenofovir v telesu široko distribuirana.
English: Seroconversions / Nb a ‘Case' = HIV seroconverter; ‘Cohort' = 100 randomly selected subjects from each of the tenofovir disoproxil 245 mg and emtricitabine/tenofovir disoproxil groups.
Slovenian: Nb a ''Študijska skupina'' = serokonverter HIV; „kohorta“ = 100 naključno izbranih oseb iz vsake od skupin, ki so prejemale dizoproksiltenofovirat 245 mg in emtricitabin/dizoproksiltenofovirat.