natgillin/translations-raw huggingface dataset:
Rare: renal failure (acute and chronic), proximal renal tubulopathy including Fanconi syndrome, increased creatinine, proteinuria Very rare: acute tubular necrosis Not known: nephritis (including acute interstitial nephritis), nephrogenic diabetes insipidus.
Redko: ledvična odpoved (akutna in kronična), proksimalna ledvična tubulopatija vključujoč Fankoni sindrom, povišan kreatinin, proteinurija Zelo redko: akutna tubularna nekroza Pogostost ni znana: nefritis (vključno z akutnim intersticijskim nefritisom), nefrogeni insipidusni diabetes
Common: pain, asthenia
Pogosto: bolečina, astenija
9 The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), hypokalaemia, muscular weakness, myopathy and hypophosphataemia.
Naslednji neželeni učinki, našteti pod zgoraj navedenimi organskimi sistemi, se lahko pojavijo kot posledica proksimalne ledvične tubulopatije: rabdomioliza, osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom), hipokaliemija, mišična oslabelost, miopatija in hipofosfatemija.
These events are not considered to be causally associated with tenofovir disoproxil fumarate therapy in the absence of proximal renal tubulopathy.
Teh neželenih učinkov ne štejemo med vzročno povezane z zdravljenjem s tenofovirdizoproksil fumaratom v odsotnosti proksimalne ledvične tubulopatije.
In addition anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Poleg tega je bila pogosta anemija in zelo pogosta sprememba obarvanosti kože (hiperpigmentacija) pri pediatričnih bolnikih ob jemanju emtricitabina.
HIV/ HBV or HCV co-infected patients:
Bolniki s hkratno okužbo HIV/ HBV ali HCV:
Only a limited number of patients were co-infected with HBV (n=13) or HCV (n=26) in study GS-01-934.
V študiji GS- 01- 934 je imelo hkratno okužbo HBV (n=13) ali HCV (n=26) le omejeno število bolnikov.
The adverse reaction profile of emtricitabine and tenofovir disoproxil fumarate in patients co-infected with HIV/ HBV or HIV/ HCV was similar to that observed in patients infected with HIV without co-infection.
Neželene reakcije emtricitabina in tenofovirdizoproksil fumarata pri bolnikih, ki so hkrati okuženi še s HIV/ HBV ali HIV/ HCV, so bile podobne tistim, ki jih imajo bolniki, okuženi z virusom HIV brez hkratne okužbe.
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirana protiretrovirusna terapija je povezana s presnovnimi anomalijami, kot so hipertrigliceridemija, hiperholesterolemija, rezistenca na insulin, hiperglikemija in hiperlaktatemija (glejte poglavje 4. 4).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see section 4.4).
Pri bolnikih s HIV je kombinirana protiretrovirusna terapija povezana s prerazporeditvijo telesnih maščob (lipodistrofija), vključno z izgubo periferne in obrazne podkožne maščobe, povečanjem količine intraabdominalne in visceralne maščobe, hipertrofijo prsi in dorzocervikalnim kopičenjem maščobe (bivolja grba) (glejte poglavje 4. 4).
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
V primeru prevelikega odmerka je potrebno pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4. 8) in mu nuditi standardno podporno zdravljenje.
Mechanism of action and pharmacodynamic effects:
Mehanizem delovanja in farmakodinamski učinki:
Tenofovir disoproxil fumarate is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Tenofovirdizoproksil fumarat se in vivo pretvori v tenofovir, nukleozidni monofosfatni (nukleotidni) analog adenozin monofosfata.
Both emtricitabine and tenofovir have activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus.
Tako emtricitabin kot tenofovir imata aktivnost, ki je specifična za humani virus imunske pomanjkljivosti (HIV- 1 in HIV- 2) in virus hepatitisa B.
10 Emtricitabine and tenofovir are phosphorylated by cellular enzymes to form emtricitabine triphosphate and tenofovir diphosphate, respectively.
Celični encimi fosforilirajo emtricitabin v emtricitabin trifosfat in tenofovir v tenofovir difosfat.
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.
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.
Antiviral activity in vitro:
Protivirusna aktivnost 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.
Rezistenca je bila opažena in vitro in pri nekaterih bolnikih, okuženih s HIV, zaradi razvoja mutacije M184V/ I pri emtricitabinu ali mutacije K65R pri tenofovirju.
Emtricitabine-resistant viruses with the M184V/ I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, zalcitabine and zidovudine.
Virusi odporni na emtricitabin z mutacijo M184V/ I so bili navzkrižno odporni na lamivudin, a so ohranili občutljivost za didanozin, stavudin, tenofovir, zalcitabin in zidovudin.
The K65R mutation can also be selected by abacavir, didanosine or zalcitabine and results in reduced susceptibility to these agents plus lamivudine, emtricitabine and tenofovir.
Mutacijo K65R lahko izberemo tudi z abakavirjem, didanozinom ali zalcitabinom, kar povzroči zmanjšano občutljivost na ta zdravila ter na lamivudin, emtricitabin in tenofovir.
Tenofovir disoproxil fumarate should be avoided in patients with HIV-1 harbouring the K65R mutation.
Uporabi tenofovirdizoproksil fumarata se je potrebno izogniti pri bolnikih s HIV- 1, nosilci mutacije K65R.
Patients with HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil fumarate.
Bolniki, pri katerih je HIV- 1 izražal tri ali več mutacij povezanih z analogom timidina (TAM, thymidine- analogue associated mutations), ki so vsebovale ali M41L ali L210W mutacijo reverzne transkriptaze, so kazali zmanjšano občutljivost za zdravljenje s tenofovirdizoproksil fumaratom.
In vivo resistance (antiretroviral-naïve patients):
Rezistenca in vivo (pri bolnikih, še nezdravljenih s protiretrovirusnimi zdravili):
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.
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.
• The M184V/ I mutation developed in 2/ 19 (10.5%) isolates analysed from patients in the emtricitabine/ tenofovir disoproxil fumarate/ 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 fumarate group to the lamivudine/ zidovudine group among all subjects). • No virus analysed contained the K65R mutation. • Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from 13/ 19 (68%) patients in the emtricitabine/ tenofovir disoproxil fumarate/ efavirenz group and in virus from 21/ 29 (72%) patients in the comparative group.
• se je mutacija M184V/ I razvila pri 2/ 19 (10, 5%) izolatov, ki so jih analizirali pri bolnikih v skupini, ki je prejemala emtricitabin/ tenofovirdizoproksil fumarat/ 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 tenofovirdizoproksil fumaratom primerjal s skupino z lamivudinom/ zidovudinom pri vseh osebah); • noben analiziran virus ni vseboval mutacije K65R; • genotipska rezistenca za efavirenz, predvsem mutacija K103N, se je razvila v virus pri 13/ 19 (68%) bolnikov v skupini, ki je prejemala emtricitabin/ tenofovirdizoproksil fumarat/ efavirenz, in pri 21/ 29 (72%) bolnikov v primerjalni skupini.
In an open-label randomised clinical study (GS-01-934), antiretroviral-naïve HIV-1 infected patients received either a once daily regimen of emtricitabine, tenofovir disoproxil fumarate and efavirenz (n=255) or a fixed combination of lamivudine and zidovudine (Combivir) administered twice daily and efavirenz once daily (n=254).
V odprti, randomizirani klinični študiji (GS- 01- 934) so bolniki z okužbo HIV- 1, ki še niso bili zdravljeni s protiretrovirusnimi zdravili, prejemali režim zdravljenja z emtricitabinom, tenofovirdizoproksil fumaratom in efavirenzom (n=255) enkrat na dan ali fiksno kombinacijo
Patients in the emtricitabine and tenofovir disoproxil fumarate group were given Truvada and efavirenz from week 96 to week 144.
Bolniki v skupini, ki je prejemala emtricitabin in tenofovirdizoproksil fumarat, so prejemali zdravilo Truvada in efavirenz od 96. do 144. tedna.
At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/ ml) and CD4 counts (233 and 241 cells/ mm3).
Na začetku študije so imele randomizirane skupine podobno mediano števila HIV- 1 RNA v plazmi (5, 02 in 5, 00 log10 kopij/ ml) in CD4 (233 in 241 celic/ mm3).
The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV-1 RNA concentrations < 400 copies/ ml over 48 weeks.
Primarni cilj učinkovitosti pri tej študiji je bilo doseganje in vzdrževanje potrjenih koncentracij HIV- 1 RNA < 400 kopij/ ml v 48 tednih.
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.
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.
The 48-week primary endpoint data showed that the combination of emtricitabine, tenofovir disoproxil fumarate and efavirenz provided superior antiviral efficacy as compared with the fixed combination of lamivudine and zidovudine (Combivir) with efavirenz as shown in Table 1.
Podatki za primarni cilj po 48 tednih so pokazali, da je imela kombinacija emtricitabina, tenofovirdizoproksil fumarata in efavirenza večjo protivirusno učinkovitost kot fiksna kombinacija lamivudina in zidovudina (Combivir) z efavirenzom, kot je prikazano v tabeli 1.
The 144 week secondary endpoint data are also presented in Table 1.
Tudi podatki za sekundarni cilj po 144 tednih so predstavljeni v tabeli 1.
11 Table 1:
Tabela 1:
48- and 144-week efficacy data from study GS-01-934 in which emtricitabine, tenofovir disoproxil fumarate and efavirenz were administered to antiretroviral-naïve patients with HIV-1 infection
Podatki o učinkovitosti po 48. in 144. tednu v študiji GS- 01- 934, v kateri so emtricitabin, tenofovirdizoproksil fumarat in efavirenz dajali bolnikom z okužbo HIV- 1, ki še niso bili zdravljeni s protiretrovirusnimi zdravili
Treatment for 48 weeks
48- tedensko zdravljenje
Treatment for 144 weeks
144- tedensko zdravljenje
Lamivudine+ Emtricitabin
Lamivudin+ Emtricitabi
tenofovir disoproxil fumarate+efavirenz
tenofovirdizoproksil fumarat+efavirenz
tenofovir disoproxil fumarate+efavirenz*
tenofovirdizoproksil fumarat+efavirenz *
HIV-1 RNA < 400 copies/ ml (TLOVR)
HIV- 1 RNA < 400 kopij/ ml (TLOVR)
% difference (95%CI)
Razlika v% (95% IZ)
(4% to 19%)
(4% do 19%)
(4% to 22%)
(4% do 22%)
HIV-1 RNA < 50 copies/ ml (TLOVR)
HIV- 1 RNA < 50 kopij/ ml (TLOVR)
9%
9% (2% do 17%)
(2% to 17%)
8%
8% (-1% to 17%)
(- 1% do 17%)
Mean change from baseline in CD4 cell count (cells/ mm3)
Srednja sprememba števila celic CD4 od začetka študije (celic/ mm3)
p-value Difference (95%CI)
Razlika (95% IZ)
0.002a 32 (9 to 55)
32 (9 do 55)
0.089a 41 (4 to 79)
41 (4 do 79)
* Patients receiving emtricitabine, tenofovir disoproxil fumarate and efavirenz were given Truvada plus efavirenz from week 96 to 144. ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR=Time to Loss of Virologic Response a:
* Bolniki, ki so prejemali emtricitabin, tenofovirdizoproksil fumarat in efavirenz, so dobivali zdravilo Truvada in efavirenz od 96. do 144. tedna. ** Vrednost p temelji na Cochran- Mantel- Haenszlovem testu, stratificiranem za število celic CD4 na začetku študije.
Van Elteren Test
Van Elternov test
In a separate randomised clinical study (M02-418), one hundred and ninety antiretroviral-naïve adults were also treated once daily with emtricitabine and tenofovir disoproxil fumarate in combination with lopinavir/ ritonavir given once or twice daily.
V ločeni randomizirani klinični študiji (M02- 418) so 190 odraslih, ki še niso bili zdravljeni s protiretrovirusnim zdravilom, enkrat dnevno zdravili tudi z emtricitabinom in tenofovirdizoproksil fumaratom v kombinaciji z lopinavirjem/ ritonavirjem enkrat ali dvakrat na dan.
At 48 weeks, 70% and 64% of patients demonstrated HIV-1 RNA < 50 copies/ ml with the once and twice daily regimens of lopinavir/ ritonavir, respectively.
V 48. tednu je 70% bolnikov v režimu zdravljenja z lopinavirjem/ ritonavirjem enkrat na dan in 64% bolnikov v režimu zdravljenja z lopinavirjem/ ritonavirjem dvakrat na dan izkazalo HIV- 1 RNA < 50 kopij/ ml.
The mean changes in CD4 cell count from baseline were +185 cells/ mm3 and +196 cells/ mm3 with the once and twice daily regimens of lopinavir/ ritonavir, respectively.
Srednje spremembe števila celic CD4 so bile od začetka študije +185 celic/ mm3 pri skupini v režimu zdravljenja z lopinavirjem/ ritonavirjem enkrat na dan in +196 celic/ mm3 pri skupini v režimu zdravljenja z lopinavirjem/ ritonavirjem dvakrat na dan.
Limited clinical experience in patients co-infected with HIV and HBV suggests that treatment with emtricitabine or tenofovir disoproxil fumarate in antiretroviral combination therapy to control HIV infection also results in a reduction in HBV DNA (3 log10 reduction or 4 to 5 log10 reduction, respectively) (see section 4.4).
4 do 5 log10 pri tenofovirdizoproksil fumaratu) (glejte poglavje 4. 4).
The bioequivalence of one Truvada film-coated tablet with one emtricitabine 200 mg hard capsule and one tenofovir disoproxil fumarate 245 mg film-coated tablet was established following single dose administration to fasting healthy subjects.
Bioekvivalenca ene Truvada filmsko obložene tablete z eno 200 mg trdo kapsulo emtricitabina in eno 245 mg filmsko obloženo tableto tenofovirdizoproksil fumarata je bila ugotovljena po zaužitju enkratnega odmerka pri zdravih osebah na tešče.
Following oral administration of Truvada to healthy subjects, emtricitabine and tenofovir disoproxil fumarate are rapidly absorbed and tenofovir disoproxil fumarate is converted to tenofovir.
Pri zdravih osebah se po peroralnem vnosu zdravila Truvada emtricitabin in tenofovirdizoproksil fumarat hitro absorbirata in tenofovirdizoproksil fumarat se pretvori v tenofovir.
Maximum emtricitabine and tenofovir concentrations are observed in serum within 0.5 to 3.0 h of dosing in the fasted state.
Najvišje koncentracije emtricitabina in tenofovirja so opažene v serumu znotraj 0, 5 ure do 3, 0 ur po zaužitju na tešče.
12 Distribution:
Porazdelitev:
Following intravenous administration the volume of distribution of emtricitabine and tenofovir was approximately 1.4 l/ kg and 800 ml/ kg, respectively.
Po intravenskem odmerku je volumen porazdelitve emtricitabina znašal približno 1, 4 l/ kg in volumen porazdelitve tenofovirja približno 800 ml/ kg.
After oral administration of emtricitabine or tenofovir disoproxil fumarate, emtricitabine and tenofovir are widely distributed throughout the body.
Po peroralnem vnosu emtricitabina ali tenofovirdizoproksil fumarata sta emtricitabin in tenofovir v telesu široko distribuirana.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/ ml.
In vitro je bila vezava emtricitabina na humane plazemske proteine manj kot 4% in je neodvisna od koncentracije v razponu med 0, 02 in 200 µg/ ml.
In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/ ml.
In vitro je bila vezava tenofovirja na plazemske proteine manjša od 0, 7% oziroma na serumske proteine manjša od 7, 2% v koncentracijskem območju tenofovirja od 0, 01 do 25 µg/ ml.
In vitro studies have determined that neither tenofovir disoproxil fumarate nor tenofovir are substrates for the CYP450 enzymes.
In vitro študije so pokazale, da niti tenofovirdizoproksil fumarat niti tenofovir nista substrata za CYP450 encime.
Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Tenofovir se primarno izloča preko ledvic tako s filtracijo kot z aktivnim tubularnim transportnim sistemom, pri čemer se po intravenskem vnosu približno 70- 80% odmerka izloči nespremenjenega z urinom.
The apparent clearance of tenofovir averaged approximately 307 ml/ min.
Navidezni očistek tenofovirja je povprečno znašal približno 307 ml/ min.
Renal clearance has been estimated to be approximately 210 ml/ min, which is in excess of the glomerular filtration rate.
Ocenjeno je, da znaša ledvični očistek približno 210 ml/ min, kar presega nivo glomerularne filtracije.
Pharmacokinetic studies have not been performed with tenofovir in children and adolescents (under 18 years).
Farmakokinetične študije s tenofovirjem niso bile izvedene pri otrocih in mladostnikih (mlajših od 18 let).
Pharmacokinetic studies have not been performed with emtricitabine or tenofovir in the elderly (over 65 years).
Farmakokinetične študije z emtricitabinom ali tenofovirjem niso bile izvedene pri starejših (nad 65 let).
Limited pharmacokinetic data are available for emtricitabine and tenofovir after co-administration of separate preparations or as Truvada in patients with renal impairment.
Na voljo je malo farmakokinetičnih podatkov za emtricitabin in tenofovir po sočasnem jemanju ločenih pripravkov ali v obliki zdravila Truvada pri bolnikih z motnjami v delovanju ledvic.
Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Farmakokinetične parametre so v glavnem določili po vzetju enkratnih odmerkov 200 mg emtricitabina ali 245 mg tenofovirdizoproksilata pri bolnikih, ki niso bili okuženi s HIV, z različnimi motnjami v delovanju ledvic.
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).
Stopnja motnje v delovanju ledvic je bila določena glede na začetno vrednost očistka kreatinina (ClCr) (normalna ledvična funkcija je pri ClCr > 80 ml/ min; blaga
The mean (%CV) emtricitabine drug exposure increased from 12 (25%) µg• h/ ml in subjects 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 blagimi motnjami v delovanju ledvic zvišala na 20 (6%) µg• h/ ml, pri bolnikih z zmernimi motnjami na 25 (23%) µg• h/ ml in na 34 (6%) µg• h/ ml pri bolnikih s hudimi motnjami v delovanju ledvic.
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 blagimi motnjami v delovanju ledvic zvišala na 3. 064 (30%) ng• h/ ml, pri bolnikih z zmernimi motnjami na 6. 009 (42%) ng• h/ ml in na 15. 985 (45%) ng• h/ ml pri bolnikih s hudimi motnjami v delovanju ledvic.
The increased dose interval for Truvada in patients with moderate renal impairment is expected to result in higher peak plasma concentrations and lower Cmin levels as compared to patients with normal renal function.
Pričakuje se, da se bo odmerjanje zdravila Truvada v daljših časovnih intervalih za bolnike z zmernimi motnjami v delovanju ledvic odražalo v višjih najvišjih plazemskih koncentracijah in nižjih nivojih Cmin v primerjavi z bolniki z normalno ledvično funkcijo.
13 In patients 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.
Pri bolnikih z ledvičnim obolenjem v končni fazi (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.
It is recommended that the dosing interval for Truvada is modified in patients with creatinine clearance between 30 and 49 ml/ min.
Priporočljivo je prilagoditi interval med odmerki za zdravilo Truvada pri bolnikih z očistkom kreatinina med 30 in 49 ml/ min.
Truvada is not suitable for patients with CrCl < 30 ml/ min or for those on haemodialysis (see section 4.2).
Zdravilo Truvada ni primerno za bolnike s CLCR < 30 ml/ min ali za bolnike na hemodializi (glejte poglavje 4. 2).
A small clinical study was conducted to evaluate the safety, antiviral activity and pharmacokinetics of tenofovir disoproxil fumarate in combination with emtricitabine in HIV infected patients with renal impairment.
Izvedena je bila majhna klinična študija za ocenitev varnosti, protivirusne aktivnosti in farmakokinetike tenofovirdizoproksil fumarata v kombinaciji z emtricitabinom pri bolnikih, okuženih z virusom HIV z motnjami v delovanju ledvic.
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.
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.
The pharmacokinetics of Truvada have not been studied in patients with hepatic impairment.
Farmakokinetike zdravila Truvada niso proučevali pri bolnikih z motnjami v delovanju jeter.
However, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment.
Vendar je malo verjetno, da bi bilo potrebno prilagoditi odmerek zdravila Truvada pri bolnikih z motnjami v delovanju jeter.