FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean rate of BMD gain was less in the tenofovir disoproxil group compared to the placebo group.
Slovenian: Povprečna stopnja povečanja MGK je bila manjša v skupini z dizoproksiltenofoviratom v primerjavi s skupino s placebom.
English: Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Slovenian: Dizoproksiltenofovirat se in vivo pretvori v tenofovir, nukleozidni monofosfatni (nukleotidni) analog adenozin monofosfata.
English: Adults with renal impairment:
Slovenian: Odrasli z ledvično okvaro:
English: Renal and bone effects in adults Renal effects
Slovenian: Učinki na kosti in ledvice pri odraslih
English: Emtricitabine and tenofovir pharmacokinetics are similar in male and female patients.
Slovenian: Farmakokinetične lastnosti emtricitabina in tenofovirja so podobne pri bolnikih moškega in ženskega spola.
English: Severe renal impairment (CrCl <30 mL/min) and haemodialysis patients
Slovenian: Huda ledvična okvara (CrCl < 30 ml/min) in bolniki na hemodializi
English: Taking Emtricitabine/Tenofovir disoproxil Mylan with other medicines containing didanosine (for treatment of HIV infection): Taking emtricitabine/tenofovir disoproxil with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Slovenian: Jemanje zdravila Emtricitabin/dizoproksiltenofovirat Mylan z drugimi zdravili, ki vsebujejo didanozin (za zdravljenje okužbe z virusom HIV): jemanje emtricitabina/dizoproksiltenofovirata z drugimi protivirusnimi zdravili, ki vsebujejo didanozin, lahko zviša nivoje didanozina v krvi in zmanjša število celic CD4.
English: Dose interval adjustments are recommended for HIV-1 infected patients with creatinine clearance 30-49 mL/min (see section 4.2).
Slovenian: Intervale med odmerki je priporočljivo prilagoditi pri bolnikih s HIV-1, ki imajo očistek kreatinina med 30 in 49 ml/min (glejte poglavje 4.2).
English: Some patients taking combination antiretroviral medicines such as emtricitabine/tenofovir disoproxil may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Slovenian: Pri nekaterih bolnikih, ki jemljejo kombinacijo protiretrovirusnih zdravil, kot je emtricitabin/dizoproksiltenofovirat, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva zaradi nezadostne prekrvitve kosti).
English: If a dose of emtricitabine/tenofovir disoproxil is missed by more than 12 hours and it is almost time for the next dose, the missed dose should not be taken and the usual dosing schedule should be resumed.
Slovenian: Če se izpusti odmerek emtricitabina/dizoproksiltenofovirata za več kot 12 ur in je že skoraj čas za naslednji odmerek, se izpuščenega odmerka ne sme vzeti in se nadaljuje z jemanjem po običajnem režimu odmerjanja.
English: Emtricitabine and tenofovir have been shown to be excreted in human milk.
Slovenian: Pokazalo se je, da se emtricitabin in tenofovir izločata v materino mleko.
English: Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
Slovenian: 13 % odmerka emtricitabina je iz urina izoliranega v obliki treh presnovkov.
English: The effects of tenofovir disoproxil-associated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Slovenian: Učinki sprememb v MKG zaradi dizoproksiltenofovirata na dolgoročno zdravje kosti in tveganje za prihodnje zlome trenutno niso znani (glejte poglavje 5.1).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Slovenian: Glavni opisani neželeni učinki so hematološke motnje (anemija, nevtropenija) in presnovne motnje (hiperlaktatemija, hiperlipazemija).
English: It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Slovenian: Pomembno je tudi, da zdravnika obvestite o tem, če jemljete ledipasvir/sofosbuvir, sofosbuvir/velpatasvir ali sofosbuvir/velpatasvir/voksilaprevir za zdravljenje okužbe s hepatitisom C.
English: In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi CART nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resna klinična stanja ali poslabšanje simptomov.
English: 3 This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies for emtricitabine or in randomised controlled clinical studies or the tenofovir disoproxil expanded access program for tenofovir disoproxil.
Slovenian: 3 Ta neželeni učinek je bil opredeljen v okviru nadzora v obdobju trženja zdravila, vendar ga v randomiziranih kontroliranih kliničnih študijah pri odraslih ali v kliničnih študijah emtricitabina pri otrocih s HIV ali v randomiziranih kontroliranih kliničnih študijah dizoproksiltenofovirata ali v podaljšanem programu dostopanja do dizoproksiltenofovirata niso opazili.
English: Therefore, a careful benefit-risk assessment is needed when emtricitabine/tenofovir disoproxil is used in patients with creatinine clearance < 60 mL/min, and renal function should be closely monitored.
Slovenian: Zato je treba skrbno oceniti razmerje med koristmi in tveganjem pri uporabi emtricitabina/dizoproksiltenofovirata pri bolnikih z očistkom kreatinina < 60 ml/min in skrbno spremljati delovanje ledvic.
English: elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia abdominal pain, abdominal distension, flatulence
Slovenian: zvišana amilaza vključno z zvišano pankreasno amilazo, povišanje serumske lipaze, bruhanje, bolečine v trebuhu, dispepsija bolečine v trebuhu, napenjanje, flatulenca
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Slovenian: Pri bolnikih s tveganjem ledvične okvare (kot so bolniki z dejavniki tveganja za ledvice ob izhodišču, napredovalo boleznijo HIV ali bolniki, ki sočasno prejemajo nefrotoksična zdravila) je tveganje za nepopolno okrevanje ledvične funkcije kljub prekinitvi uporabe dizoproksiltenofovirata večje (glejte poglavje 4.4).
English: • Emtricitabine/Tenofovir disoproxil Mylan is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults.
Slovenian: • Zdravilo Emtricitabin/dizoproksiltenofovirat Mylan se uporablja za zdravljenje okužbe z virusom HIV-1 (virus človeške imunske pomanjkljivosti 1) pri odraslih.
English: • If you take Emtricitabine/Tenofovir disoproxil Mylan for the treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Slovenian: • Če zdravilo Emtricitabin/dizoproksiltenofovirat Mylan jemljete za zdravljenje okužbe s HIV, lahko prenehanje jemanja tablet zmanjša učinkovitost zdravljenja okužbe s HIV, ki vam ga je predpisal zdravnik.
English: Emtricitabine is a nucleoside analogue of cytidine.
Slovenian: Emtricitabin je nukleozidni analog citidina.
English: A multidisciplinary approach is recommended to weigh the benefit/risk balance of emtricitabine/tenofovir disoproxil for the treatment of HIV-1 infection or for pre-exposure prophylaxis, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation on a case by case basis.
Slovenian: Priporoča se multidisciplinarni pristop, s katerim se presodi o razmerju med koristmi in tveganji zdravljenja okužbe z virusom HIV-1 ali zaščite neokuženih mladostnikov pred izpostavitvijo z emtricitabinom/dizoproksiltenofoviratom, in sprejme odločitev glede ustreznega spremljanja med zdravljenjem (vključno z odločitvijo o prenehanju zdravljenja) ter razmisli o potrebi po dodatnem zdravljenju za vsakega posameznega bolnika.
English: • If you are taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV, do not stop taking this medicine or miss any doses.
Slovenian: • Če zdravilo Emtricitabin/dizoproksiltenofovirat Mylan jemljete za zmanjšanje tveganja za okužbo s HIV, ne prenehajte jemati tega zdravila in ne izpustite nobenega odmerka.
English: Moderate renal impairment (CrCl 30-49 mL/min)
Slovenian: Zmerna ledvična okvara (CrCl 30-49 ml/min)
English: Do not take Emtricitabine/Tenofovir disoproxil Mylan to treat HIV or to reduce the risk of getting HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Emtricitabin/dizoproksiltenofovirat Mylan za zdravljenje okužbe s HIV ali za zmanjšanje tveganja za okužbo s HIV, če ste alergični na emtricitabin, tenofovir, dizoproksiltenofovirat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Immune Reactivation Syndrome: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Slovenian: Sindrom imunske reaktivacije: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi CART nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe.
English: Genotoxicity studies revealed positive results in the in vitro mouse lymphoma assay, equivocal results in one of the strains used in the Ames test, and weakly positive results in an UDS test in primary rat hepatocytes.
Slovenian: Študije genotoksičnosti so pokazale pozitivne rezultate pri in vitro testiranju celic mišjega limfoma, v enem od sevov, uporabljenem v Ames testu, so bili rezultati nezanesljivi, v testu nenačrtovane sinteze DNA (unscheduled DNA synthesis, UDS) na primarnih podganjih hepatocitih pa so bili šibko pozitivni.
English: Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Slovenian: Zmanjšanje MKG hrbtenice in spremembe kostnih biomarkerjev od začetne vrednosti so bile po 144 tednih pomembno večje v skupini, ki se je zdravila z dizoproksiltenofoviratom.
English: • decreases in phosphate in the blood
Slovenian: • zmanjšanje količine fosfata v krvi
English: - Emtricitabine/Tenofovir disoproxil Mylan should always be used combined with other medicines to treat HIV infection.
Slovenian: • Zdravilo Emtricitabin/dizoproksiltenofovirat Mylan je treba vedno uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
English: Velpatasvir: AUC: ↑ 142% (↑ 123 to
Slovenian: velpatasvir: AUC: ↑ 142 % (↑ 123 do
English: 1 Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Slovenian: 1 Podatki na podlagi sočasnega odmerjanja ledipasvirja/sofosbuvirja.
English: Emtricitabine/tenofovir disoproxil is not recommended if you have severe kidney disease or are on dialysis.
Slovenian: Uporaba emtricitabina/dizoproksiltenofovirata ni priporočljiva, če imate hudo ledvično obolenje ali ste na dializi.
English: Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Slovenian: Anomalije na kosteh (redko prispevajo k zlomom) so lahko povezane s proksimalno ledvično tubulopatijo (glejte poglavje 4.8).
English: There is insufficient information on the effects of emtricitabine and tenofovir in newborns/infants.
Slovenian: Podatki o učinku emtricitabina in tenofovirja na dojene novorojence/otroke so nezadostni.
English: Tenofovir disoproxil: Non-clinical safety pharmacology studies on tenofovir disoproxil reveal no special hazard for humans.
Slovenian: Dizoproksiltenofovirat: Predklinične študije farmakološke varnosti za dizoproksiltenofovirat ne kažejo posebnega tveganja za človeka.
English: Prior to initiating Emtricitabine/Tenofovir disoproxil Mylan for the treatment of HIV-1 infection or for use in pre-exposure prophylaxis, it is recommended that creatinine clearance is calculated in all individuals.
Slovenian: Pred začetkom jemanja zdravila Emtricitabin/dizoproksiltenofovirat Mylan za zdravljenje okužbe s HIV-1 ali za uporabo za zaščito pred izpostavitvijo se priporoča izračun očistka kreatinina pri vseh posameznikih.
English: In clinical studies of HIV-1 uninfected individuals, small decreases in BMD were observed.
Slovenian: V kliničnih študijah posameznikov, ki niso bili okuženi s HIV-1, so opazili majhno zmanjšanje mineralne gostote kosti (MGK).
English: hypokalaemia1
Slovenian: hipokaliemija1
English: - Emtricitabine/Tenofovir disoproxil Mylan can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
Slovenian: • Zdravilo Emtricitabin/dizoproksiltenofovirat Mylan se lahko jemlje namesto emtricitabina in dizoproksiltenofovirata, ki se uporabljata ločeno v enakih odmerkih.
English: Involved in Transactional Sex Last 6 Month, N (%) Known HIV+ Partner Last 6 Months, N (%) Syphilis Seroreactivity, N (%)
Slovenian: URAI v preteklih 12 tednih, N (%) URAI s partnerji s HIV+ (ali neznanim statusom okužbe) v preteklih 6 mesecih, N (%) Sodelovanje v transakcijskem spolnem odnosu v preteklih 6 mesecih, N (%) Znani partnerji s statusom HIV+ v preteklih 6 mesecih, N (%)
English: Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected subjects with varying degrees of renal impairment.
Slovenian: Farmakokinetične parametre so v glavnem določili po vzetju enkratnih odmerkov 200 mg emtricitabina ali 245 mg dizoproksiltenofovirata pri osebah, ki niso bile okužene s HIV, z različnimi stopnjami ledvične okvare.
English: 11% (4% to 19%)
Slovenian: 11 % (4 % do 19 %)
English: Pre-exposure prophylaxis: The iPrEx study (CO-US-104-0288) evaluated emtricitabine/tenofovir disoproxil or placebo in 2,499 HIV-uninfected men (or transgender women) who have sex with men and who were considered at high risk for HIV infection.
Slovenian: Zaščita pred izpostavitvijo: Študija iPrEx (CO-US-104-0288) je ocenjevala emtricitabin/dizoproksiltenofovirat ali placebo pri 2.499 moških (ali transspolnih ženskah), ki niso bili okuženi s HIV in imajo spolne odnose z moškimi in ki imajo visoko tveganje za okužbo s HIV.
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Slovenian: V drugih študijah (prospektivne in presečne) so najbolj izrazito zmanjšanje MKG opazili pri bolnikih, zdravljenih z dizoproksiltenofoviratom z okrepljenim zaviralcem proteaze.
English: Interrupting use of emtricitabine/tenofovir disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified.
Slovenian: O prekinitvi uporabe emtricitabina/dizoproksiltenofovirata je treba razmisliti tudi v primeru progresivnega upada ledvične funkcije, če ni bil ugotovljen noben drug razlog.
English: Medis International a.s Bolatice, Prumyslova 961/16, 747 23 Bolatice, Czech Republic
Slovenian: Medis International a.s Bolatice, Prumyslova 961/16, 747 23 Bolatice Češka
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
Slovenian: V 144 tednov trajajoči kontrolirani klinični študiji, v kateri so primerjali dizoproksiltenofovirat in stavudin v kombinaciji z lamivudinom in efavirenzom pri predhodno nezdravljenih bolnikih s protiretrovirusnimi zdravili, so pri obeh skupinah opazili majhno zmanjšanje mineralne kostne gostote (MKG) kolka in hrbtenice.
English: Tenofovir disoproxil is indicated for the treatment of HBV and emtricitabine has shown activity against HBV in pharmacodynamic studies but the safety and efficacy of emtricitabine/tenofovir disoproxil have not been specifically established in patients with chronic HBV infection.
Slovenian: Dizoproksiltenofovirat je indiciran za zdravljenje okužbe z virusom HBV. Emtricitabin je v farmakodinamičnih študijah pokazal delovanje proti virusu HBV, vendar varnost in učinkovitost emtricitabina/dizoproksiltenofovirata nista bili posebej ugotovljeni pri bolnikih s kronično okužbo z virusom HBV.
English: The combination should be used with caution with frequent renal monitoring, if other alternatives are not available (see section 4.4).
Slovenian: To kombinacijo je treba uporabljati pazljivo s pogostim spremljanjem delovanja ledvic, če druge možnosti niso na voljo (glejte poglavje 4.4).
English: In subjects with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 (19%) µg•h/mL of emtricitabine, and over 48 hours to 42,857 (29%) ng•h/mL of tenofovir.
Slovenian: Pri osebah s končno odpovedjo ledvic (ESRD, end-stage renal disease), ki so potrebovali hemodializo, se je med dializami izpostavljenost zdravilu znatno povišala v obdobju 72 ur na 53 (19 %) µg•h/ml emtricitabina in v obdobju 48 ur na 42.857 (29 %) ng•h/ml tenofovirja.
English: No clinically important pharmacokinetic difference due to ethnicity has been identified for emtricitabine.
Slovenian: Za emtricitabin ni bilo identificirane klinično pomembne farmakokinetične razlike glede na etnično pripadnost.
English: Individuals should be re-confirmed to be HIV-negative at frequent intervals (e.g. at least every 3 months) using a combined antigen/antibody test while taking emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis.
Slovenian: Posamezniki morajo negativni status okužbe s HIV redno potrjevati (npr. najmanj vsake 3 mesece) z uporabo kombiniranega testa na antigen/protitelesa, pri tem pa morajo za zaščito pred izpostavitvijo jemati emtricitabin/dizoproksiltenofovirat.
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: Pri bolnikih z napredovalo boleznijo jeter ali cirozo prekinitev zdravljenja ni priporočena, saj poslabšanje hepatitisa po zdravljenju lahko povzroči jetrno dekompenzacijo.
English: Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations < 400 or < 50 copies/mL, and change from baseline in CD4 cell count.
Slovenian: Sekundarne analize učinkovitosti v 144 tednih so vključile del bolnikov s koncentracijo HIV-1 RNA < 400 ali < 50 kopij/ml in spremembo števila celic CD4 od začetka študije.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
English: In vitro: Resistance has been seen in vitro and in some HIV-1 infected patients due to the development of the M184V/I mutation with emtricitabine or the K65R mutation with tenofovir.
Slovenian: In vitro: Rezistenca je bila opažena in vitro in pri nekaterih bolnikih, okuženih s HIV-1, zaradi razvoja mutacije M184V/I pri emtricitabinu ali mutacije K65R pri tenofovirju.
English: Moreover, the reversibility of renal toxicity after cessation of tenofovir disoproxil for the treatment of HIV-1 infection or after cessation of emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis cannot be fully ascertained.
Slovenian: Tudi reverzibilnosti toksičnosti za ledvice po prenehanju zdravljenja HIV-1 z dizoproksiltenofoviratom ali po prekinitvi uporabe emtricitabina/dizoproksiltenofovirata za zaščito pred izpostavitvijo ni mogoče z gotovostjo določiti.
English: In order to optimise the absorption of tenofovir, it is recommended that emtricitabine/tenofovir disoproxil should preferably be taken with food.
Slovenian: Za optimalno absorpcijo tenofovirja je priporočljivo emtricitabin/dizoproksiltenofovirat jemati s hrano.
English: The K65R mutation can also be selected by abacavir or didanosine and results in reduced susceptibility to these agents plus lamivudine, emtricitabine and tenofovir.
Slovenian: Mutacija K65R se lahko razvije tudi z abakavirjem ali didanozinom, kar povzroči zmanjšano občutljivost na ta zdravila ter na lamivudin, emtricitabin in tenofovir.
English: If bone abnormalities are detected or suspected during use of emtricitabine/tenofovir disoproxil in any paediatric patient, consultation with an endocrinologist and/or nephrologist should be obtained.
Slovenian: Ob odkritju kostnih nenormalnosti ali sumu nanje med uporabo emtricitabina/dizoproksiltenofovirata pri katerem koli pediatričnem bolniku se je treba posvetovati z endokrinologom in/ali nefrologom.
English: PrEP educational brochure for prescribers:
Slovenian: Izobraževalno gradivo PrEP za predpisujoče zdravnike:
English: Pharmacokinetic studies have not been performed with emtricitabine/tenofovir disoproxil in children and adolescents (under 18 years of age).
Slovenian: Farmakokinetične študije z emtricitabinom/dizoproksiltenofoviratom niso bile izvedene pri otrocih in mladostnikih (mlajših od 18 let).
English: 1 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Slovenian: 1 Ta neželeni učinek se lahko pojavi kot posledica proksimalne ledvične tubulopatije.
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of emtricitabine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Slovenian: Zdravila, ki se izločajo preko ledvic: Ker se emtricitabin in tenofovir izločata predvsem preko ledvic, lahko sočasna uporaba emtricitabina/dizoproksiltenofovirata in zdravil, ki zmanjšujejo delovanje ledvic ali tekmujejo za aktivno tubularno sekrecijo (npr. cidofovir), poveča serumske koncentracije emtricitabina, tenofovirja in/ali sočasno uporabljenih zdravil.
English: PrEP educational brochure for the individual at risk (to be provided by healthcare provider [HCP]):
Slovenian: Izobraževalno gradivo PrEP za ogrožene posameznike (ki ga priskrbi zdravstveni delavec):
English: • If you notice within 12 hours of the time you usually take Emtricitabine/Tenofovir disoproxil Mylan, take the tablet preferably with food as soon as possible.
Slovenian: • Če to opazite v roku 12 ur od časa, ko običajno vzamete zdravilo Emtricitabin/dizoproksiltenofovirat Mylan, morate tableto vzeti čim prej, najbolje s hrano.
English: Table 4: 48- and 144-week efficacy data from study GS-01-934 in which emtricitabine, tenofovir disoproxil and efavirenz were administered to antiretroviral-naïve patients with HIV-1 infection
Slovenian: Preglednica 4: Podatki o učinkovitosti po 48. in 144. tednu v študiji GS-01-934, v kateri so emtricitabin, dizoproksiltenofovirat in efavirenz dajali bolnikom z okužbo HIV-1, ki še niso bili zdravljeni s protiretrovirusnimi zdravili
English: No dose adjustment of norgestimate/ethinyl oestradiol is required.
Slovenian: Prilagoditev odmerka norgestimata/etinilestradiola ni potrebna.
English: Five subjects (5.6%) had laboratory findings clinically consistent with proximal renal tubulopathy, 4 of whom discontinued tenofovir disoproxil therapy.
Slovenian: Pri petih osebah (5,6 %) so bili laboratorijski izsledki klinično skladni s proksimalno ledvično tubulopatijo; 4 med njimi so zdravljenje z dizoproksiltenofoviratom prekinili.
English: hyperglycaemia, hypertriglyceridaemia
Slovenian: hiperglikemija, hipertrigliceridemija