natgillin/translations-raw huggingface dataset:
AUC: ↑96% (↑74 to ↑121) Cmax: ↑68% (↑54 to ↑84) Cmin: ↑118% (↑91 to ↑150)
AUC: ↑96% (↑74Cmax: ↑68% (↑54 - ↑84) Cmin: ↑118% (↑91
AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14)
AUC: ↑ 5% (↓ 2 - ↑ 13) Cmax: ↑ 5% (↓ 3 - ↑ 14)
AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
AUC: ↓ 34% (↓ 41 - ↓ Cmax: ↓ 34% (↓ 41 - ↑ Cmin: ↓ 34% (↓ 43 - ↑
AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
AUC: ↓ 25% (↓ 42 - ↓ Cmax: ↓ 28% (↓ 50 - ↑ Cmin: ↓ 26% (↓ 46 - ↑
Cmin: ↑ 39% (↑ 20 to ↑ 61)
Cmin: ↑ 39% (↑ 20
Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosinerelated adverse reactions.
Istovremena primjena tenofovirdizoproksila i didanozina rezultira 40 - 60%-tnim povećanjem sistemske izloženosti didanozinu,
AUC: ↑ 40% (↑ 34 to ↑ 45) Cmax: ↑ 46% (↑ 39 to ↑ 54) Cmin: ↑ 70% (↑ 61 to ↑ 79)
AUC:↑40% (↑34 - ↑45) Cmax:↑46% (↑ 39 - ↑54) Cmin: ↑70% (↑61 - ↑79)
Recommendation concerning co-administration with Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Preporuka za istovremenu primjenu s lijekom Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabin 200 mg, tenofovirdizoproksil 245 mg)
AUC: ↑ 32% (↑ 25 to ↑ 38) Cmax: ↔
AUC: ↑ 32% (↑ 25 - ↑ Cmax: ↔
Mixed/Other
Miješani/drugi Azijati
Age (Yrs), Mean (SD)
Dob (godine), srednja vrijednost (SD) Rasa, N (%)
The adverse reactions considered at least possibly related to treatment with the components of emtricitabine/tenofovir disoproxil from clinical study and post-marketing experience in HIV-1 infected patients are listed in Table 3, below, by body system organ class and frequency.
Nuspojave za koje se na temelju kliničkog ispitivanja i iskustva nakon stavljanja lijeka u promet u bolesnika zaraženih virusom HIV-1 smatra da su barem moguće povezane s liječenjem komponentama emtricitabinom i tenofovirdizoproksilom navedene su u sljedećoj tablici 3 po organskim sustavima i učestalosti.
AUC: ↔ Cmax: ↓ 19% (↓ 40 to ↑ 10)
AUC: ↔ Cmax: ↓ 19% (↓ 40 - ↑
Name and address of the manufacturer(s) responsible for batch release
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108)
AUC: ↓ 4% (↓ 15 - ↑ 8) Cmax: ↑ 102% (↓ 96 - ↑
AUC: ↑ 142% (↑ 123 to ↑ 164) Cmax: ↑ 55% (↑ 41 to ↑ 71) Cmin: ↑ 301% (↑ 257 to ↑ 350)
AUC: ↑ 142% (↑ 123Cmax: ↑ 55% (↑ 41Cmin: ↑ 301% (↑ 257
Emtricitabine/ tenofovir disoproxil (n = 1,579)
Emtricitabi n/ tenofovirdiz oproksil (n = 1579)
AUC: ↑ 40% (↑ 31 to ↑ 50) Cmax: ↔
AUC: ↑40% (↑ 31 - ↑ Cmax: ↔
AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0)
AUC: ↓ 11% (↓ 14 - ↓ Cmax: ↓ 7% (↓ 13 - ↓ 0)
Emtricitabine/Tenofovir disoproxil Zentiva should not be given to adolescents with existing kidney problems.
Lijek Emtricitabine/Tenofovir disoproxil Zentiva se ne smije propisati adolescentima koji imaju tegobe s bubrezima.
Consideration should be given to interrupting treatment with Emtricitabine/Tenofovir disoproxil Zentiva in patients with creatinine clearance decreased to < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Treba razmotriti mogućnost prekida liječenja lijekom Emtricitabine/Tenofovir disoproxil Zentiva u bolesnika u kojih je klirens kreatinina smanjen na < 50 ml/min ili im je vrijednost fosfata u serumu snižena na < 1,0 mg/dl
The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng·h/ml in subjects 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 subjects with mild, moderate and severe renal impairment, respectively.
Srednja vrijednost (% CV) izloženosti tenofoviru porasla je s 2185 (12%) ng•h/ml u ispitanika s normalnom bubrežnom funkcijom na 3064 (30%) ng•h/ml, 6009 (42%) ng•h/ml te
Co-administration of Emtricitabine/Tenofovir disoproxil Zentiva and didanosine is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena lijeka Emtricitabine/Tenofovir disoproxil Zentiva i didanozina (vidjeti dio 4.4).
Mean change from baseline in CD4 cell count (cells/mm3) p-value
Srednja vrijednost promjene broja CD4 stanica od početne vrijednosti
FTC/tenofovir disoproxil groupa
FTC/tenofovirdizo proksila
In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Zscore was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
U bolesnika koji su primili tenofovirdizoproksil odnosno placebo, početna srednja z-vrijednost BMD-a u području lumbalne kralježnice bila je -1,004 odnosno -0,809, a početna srednja z-vrijednost ukupnog
See Table 1.
PRILOG II.
AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1)
AUC: ↑ 26% (↑ 20 - ↑ Cmax: ↓ 5% (↓ 11 - ↑ 1)
Only samples from subjects randomized to emtricitabine/tenofovir disoproxil were evaluated for detectable plasma or intracellular tenofovir disoproxil-DP levels.
Mjerljive razine tenofovirdizoproksila-DP-a u plazmi ili unutar stanica bile su procijenjene samo u uzorcima ispitanika randomiziranih na primanje lijeka Emtricitabine/Tenofovir disoproxil Zentiva.
The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Povećana izloženost tenofoviru mogla bi pojačati nuspojave povezane s tenofovirdizoproksilom, uključujući poremećaje bubrega.
AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2)
AUC: ↓ 4% (↓ 7 - ↓ 1) Cmax: ↓ 4% (↓ 9 - ↑ 2)
The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIVinfected patients in study GS-01-934 who were co-infected with HBV (n = 13) or HCV (n = 26) was similar to that observed in patients infected with HIV without co-infection.
Bolesnici istovremeno zaraženi HIV-om i HBV-om ili HCV-om U ispitivanju GS-01-934, profil nuspojava emtricitabina i tenofovirdizoproksila u ograničenog broja bolesnika zaraženih HIV-om koji su istovremeno bili zaraženi HBV-om (n = 13) ili HCV-om (n = 26)
If serum phosphate is < 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to < 50 ml/min in any patient receiving Emtricitabine/Tenofovir disoproxil Zentiva, renal function should be reevaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Ako je u bilo kojeg bolesnika koji prima Emtricitabine/Tenofovir disoproxil Zentiva vrijednost fosfata u serumu < 1,5 mg/dl (0,48 mmol/l) ili se klirens kreatinina smanji na < 50 ml/min, unutar jednog tjedna treba ponovno procijeniti funkciju bubrega, kao i izmjeriti koncentracije glukoze u krvi, kalija u krvi i glukoze u mokraći (vidjeti dio 4.8, proksimalna tubulopatija).
AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5)
AUC: ↓ 5% (↓ 9 - ↓ 1) Cmax: ↓ 11% (↓ 17 - ↓
AUC: ↓ 53% (↓ 61 to ↓ 43) Cmax: ↓ 47% (↓ 57 to ↓ 36) Cmin: ↓ 57% (↓ 64 to ↓ 48)
AUC: ↓ 53% (↓ 61Cmax: ↓ 47% (↓ 57Cmin: ↓ 57% (↓ 64
Table 5: Study population from study CO-US-104-0288 (iPrEx)
Tablica 5: Ispitivana populacija u ispitivanju CO-US-104-0288 (iPrEx) Placebo (n = 1248)
The recommended dose of Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV is:
Preporučena doza lijeka Emtricitabine/Tenofovir disoproxil Zentiva za smanjivanje rizika od dobivanja HIV-a:
+ emtricitabine/rilpivirine/tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
+ emtricitabin/rilpivirin/tenofovirdizoproksil (200 mg/25 mg/245 mg jedanput na dan)
Individuals with renal impairment
Osobe s oštećenjem funkcije bubrega
The 48-week primary endpoint data showed that the combination of emtricitabine, tenofovir disoproxil and efavirenz provided superior antiviral efficacy as compared with the fixed combination of lamivudine and zidovudine with efavirenz as shown in Table 4.
tenofovirdizoproksila i efavirenza imala veću antivirusnu djelotvornost u usporedbi s fiksnom kombinacijom lamivudina i zidovudina s efavirenzom, kako je prikazano u tablici 4. Podaci za sekundarne mjere ishoda nakon 144 tjedna također su prikazani u tablici 4.
AUC: ↓ 29% (↓ 36 to ↓ 22) Cmax: ↓ 41% (↓ 51 to ↓ 29)
AUC: ↓ 29% (↓ 36Cmax: ↓ 41% (↓ 51
Cmin: ↑ 91% (↑ 74 to ↑ 110)
Cmin: ↑91% (↑ 74 - ↑
AUC: ↔ Cmax: ↓ 23% (↓ 30 to ↑ 16)
AUC: ↔ Cmax: ↓ 23% (↓ 30 - ↑
As Emtricitabine/Tenofovir disoproxil Zentiva contains emtricitabine and tenofovir disoproxil, any interactions that have been identified with these agents individually may occur with Emtricitabine/Tenofovir disoproxil Zentiva.
Emtricitabine/Tenofovir disoproxil Zentiva sadrži emtricitabin i tenofovirdizoproksil, pa sve interakcije koje su utvrđene u zasebnoj primjeni tih lijekova mogu nastupiti i uz
AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6)
AUC: ↓ 2% (↓ 5 - ↑ 0) Cmax: ↓ 1% (↓ 7 - ↑ 6)
The recommended dose of Emtricitabine/Tenofovir disoproxil Zentiva to treat HIV is:
Preporučena doza lijeka Emtricitabine/Tenofovir disoproxil Zentiva za liječenje HIV--a je
If serum phosphate is < 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to < 60 ml/min in any individual receiving Emtricitabine/Tenofovir disoproxil Zentiva for pre-exposure prophylaxis, renal function should be re evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Ako su u bilo koje osobe koja prima lijek Emtricitabine/Tenofovir disoproxil Zentiva za predekspozicijsku profilaksu fosfati u serumu < 1,5 mg/dl (0,48 mmol/l) ili se klirens kreatinina smanji na < 60 ml/min, unutar jednoga tjedna treba ponovno ocijeniti funkciju bubrega, kao i izmjeriti koncentracije glukoze u krvi, kalija u krvi i glukoze u mokraći (vidjeti dio 4.8, proksimalna tubulopatija).
Before taking Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV:
Prije uzimanja lijeka Emtricitabine/Tenofovir disoproxil Zentiva radi smanjenja rizika od dobivanja HIV-a:
AUC: ↓ 28% (↓ 34 to ↓ 20) Cmax: ↓ 38% (↓ 46 to ↓ 29)
AUC: ↓ 28% (↓ 34Cmax: ↓ 38% (↓ 46
Cmin: NC Emtricitabine:
Cmin: NI Emtricitabin:
AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22)
AUC: ↓ 1% (↓ 8 - ↑ 6) Cmax: ↑ 7% (↓ 6 - ↑ 22)
Common elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia abdominal pain, abdominal distension, flatulence
bolovi u abdomenu, dispepsija bolovi u abdomenu, distenzija abdomena, flatulencija
AUC: ↑ 65% (↑ 59 to ↑ 71) Cmax: ↑ 61% (↑ 51 to ↑ 72) Cmin: ↑ 115% (↑ 105 to ↑ 126)
AUC: ↑ 65% (↑ 59 - ↑ Cmax: ↑ 61% (↑ 51 - ↑ Cmin: ↑ 115% (↑105 - ↑
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 subjects with mild, moderate and severe renal impairment, respectively.
Srednja vrijednost (% koeficijenta varijacije, CV) izloženosti emtricitabinu porasla je s 12 (25%) µg•h/ml u ispitanika s normalnom funkcijom bubrega na 20 (6%) µg•h/ml,
Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva.
HIV-1 i u osoba s neotkrivenom infekcijom virusom HIV-1 koje uzimaju samo lijek Emtricitabine/Tenofovir disoproxil Zentiva pojavile su se mutacije povezane s rezistencijom virusa HIV-1.
The co-administration of Emtricitabine/Tenofovir disoproxil Zentiva and didanosine is not recommended (see section 4.4 and Table 2).
Didanozin Ne preporučuje se istovremena primjena lijeka Emtricitabine/Tenofovir disoproxil Zentiva i didanozina (vidjeti dio 4.4 i tablicu 2).
Renal and bone effects in the paediatric population There are uncertainties associated with the long-term renal and bone effects of tenofovir disoproxil during the treatment of HIV-1 infection in the paediatric population.
Pri liječenju infekcije virusom HIV-1 u pedijatrijskoj populaciji postoje nesigurnosti vezane uz dugoročne učinke tenofovirdizoproksila na bubrege i kosti.
The pharmacokinetics of emtricitabine / tenofovir disoproxil have not been studied in subjects with hepatic impairment.
Oštećenje funkcije jetre Farmakokinetika emtricitabina/tenofovirdizoproksila nije ispitana u osoba s oštećenjem funkcije jetre.
Emtricitabine/tenofovir disoproxil has not been studied in individuals over the age of 65 years.
Starije osobe Kombinacija emtricitabina/tenofovirdizoproksila nije se ispitivala u osoba starijih od 65 godina.
See also under Use with ledipasvir and sofosbuvir or sofosbuvir and velpatasvir below.
Vidjeti također odlomak „Primjena s ledipasvirom i sofosbuvirom ili sofosbuvirom i velpatasvirom“ u nastavku.
It is preferable that Emtricitabine/Tenofovir disoproxil Zentiva is taken with food.
Emtricitabine/Tenofovir disoproxil Zentiva najbolje je uzimati s hranom.
AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11)
AUC: ↓ 9% (↓ 16 - ↓ 1) Cmax: ↓ 7% (↓ 22 -↑ 11)
Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly (see section 4.4).
Lamivudin i Emtricitabine/Tenofovir disoproxil Zentiva ne smiju se primjenjivati istovremeno (vidjeti dio 4.4).
Table 1: Dosing recommendations in adults with renal impairment Treatment of HIV-1 infection Pre-exposure prophylaxis
Vidjeti tablicu 1. Tablica 1: Preporuke za doziranje u odraslih osoba s oštećenjem funkcije bubrega
AUC: ↑ 39% (↑ 33 to ↑ 44) Cmax: ↑ 55% (↑ 45 to ↑ 66) Cmin: ↑ 52% (↑ 45 to ↑ 59)
AUC: ↑ 39% (↑ 33Cmax: ↑ 55% (↑ 45Cmin: ↑ 52% (↑ 45
p-value % difference (95% CI)
% razlike (95% CI)
If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil Zentiva, another tablet should be taken.
Ako nastupi povraćanje, a prošlo je manje od 1 sata od uzimanja lijeka Emtricitabine/Tenofovir disoproxil Zentiva, treba uzeti drugu tabletu.
P-valuea, b mITT Analysis Seroconversions / N Relative Risk Reduction (95% CI)b URAI Within 12 Weeks Prior to Screening, mITT Analysis Seroconversions / N 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).
Serokonverzije / N Smanjenje relativnog rizika (95% CI)b a P-vrijednosti prema log-rang testu.
Do not take Emtricitabine/Tenofovir disoproxil Zentiva to reduce your risk unless you are confirmed to be HIV negative.
Zentiva da biste smanjili svoj rizik osim ako nije potvrđeno da ste HIV negativni.
AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24)
AUC: ↓ 4% (↓ 32 - ↑ Cmax: ↓ 5% (↓ 27 - ↑
when taken daily, together with safer sex practices: See section 2 for a list of precautions to take against HIV infection.
Pogledajte dio 2 za popis mjera opreza koje treba poduzeti za zaštitu od HIV-infekcije.
Emtricitabine/ tenofovir disoproxil
Emtricitabin/ tenofovirdizoproksil
• Although there are limited clinical data on the use of Emtricitabine/Tenofovir disoproxil Zentiva in pregnant women, it is not usually used unless absolutely necessary.
Zentiva u trudnica, pa se lijek obično ne primjenjuje osim ako to nije apsolutno potrebno.
AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1)
AUC: ↓ 7% (↓ 13 - ↓ 1) Cmax: ↓ 11% (↓ 20 - ↑
IMMUNOSUPPRESSANTS Tacrolimus/tenofovir disoproxil /emtricitabine
Takrolimus/tenofovirdizoproksil /emtricitabin
Male
DJECE
AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197)
AUC: ↑98% (↑ 77 - ↑ Cmax: ↑ 79% (↑ 56 - ↑ Cmin: ↑ 163% (↑ 137 - ↑
Atazanavir/ritonavir/emtricitabine Interaction not studied.
Atazanavir/ritonavir/emtricitabin
Treatment of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg One tablet, once daily.
Liječenje HIV-a u odraslih osoba i adolescenata u dobi od 12 godina i starijih, tjelesne težine najmanje 35 kg:
AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12)
AUC: ↓ 3% (↓ 8% - ↑ Cmax: ↓ 24% (↓ 44 -↓
In the iPrEx clinical study, no HIV-1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 after enrollment in the study.
K70E, M184V ili M184I u vrijeme serokonverzije u ispitanika koji su se zarazili virusom HIV-1 tijekom ispitivanja.
Common pain, asthenia 1 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
1 Ova nuspojava može nastati kao posljedica proksimalne bubrežne tubulopatije.
Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Emtricitabine/Tenofovir disoproxil Zentiva in patients with hepatic impairment (see sections 4.2 and 5.2).
S obzirom na minimalni jetreni metabolizam i eliminaciju emtricitabina putem bubrega, malo je vjerojatno da bi u bolesnika s oštećenjem funkcije jetre bilo potrebno prilagođavati dozu lijeka Emtricitabine/Tenofovir disoproxil
Darunavir/ritonavir/emtricitabine Interaction not studied.
Darunavir/ritonavir/emtricitabin
• Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Tenofovir disoproxil Zentiva.
• Prije početka liječenja lijekom Emtricitabine/Tenofovir disoproxil Zentiva morate provjeriti jeste li zaraženi virusom hepatitisa B (HBV).
• Reminder of the key safety information regarding the use of Emtricitabine/Tenofovir disoproxil
• Postoje tek ograničeni klinički podaci o uporabi lijeka Emtricitabine/Tenofovir disoproxil
ORAL CONTRACEPTIVES Norgestimate/ethinyl oestradiol/tenofovir disoproxil
Norgestimat/etinilestradiol/ tenofovirdizoproksil
The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
sofosbuvirom/velpatasvirom ili sofosbuvirom, velpatasvirom i voksilaprevirom i farmakokinetičkim pojačivačem nije ustanovljena.
Uncommon rhabdomyolysis1, muscular weakness1
Manje često rabdomioliza1,
Lamivudine/tenofovir disoproxil
Lamivudin/tenofovirdizoproksil
Do not stop taking Emtricitabine/Tenofovir disoproxil Zentiva
Nemojte uzimati lijek Emtricitabine/Tenofovir disoproxil
Didanosine / tenofovir disoproxil
Didanozin / tenofovirdizoproksil
AUC: ↑ 40% (↑ 34 to ↑ 46) Cmax: ↑ 44% (↑ 33 to ↑ 55) Cmin: ↑ 84% (↑ 76 to ↑ 92)
AUC: ↑ 40% (↑ 34Cmax: ↑ 44% (↑ 33Cmin: ↑ 84% (↑ 76
The incidences of HIV seroconversion overall and in the subset reporting unprotected receptive anal intercourse are shown in Table 6.
Incidencija serokonverzije HIV-a u svih ispitanika i u podskupini koja je prijavila nezaštićeni receptivni analni spolni odnos prikazani su u tablici 6. Djelotvornost je snažno korelirala s pridržavanjem terapije, kako je procijenjeno otkrivanjem razine lijeka u plazmi ili unutar stanica u ispitivanju parova (tablica 7).
General disorders and administration site conditions Very common asthenia
Opći poremećaji i reakcije na mjestu primjene Vrlo često astenija
No dose adjustment of famciclovir is required.
Nije potrebna prilagodba doze famciklovira.
• vomiting or diarrhoea
• proljev, povraćanje, mučnina
Renally eliminated medicinal products
Lijek neotkriven
Common vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)2
Često vezikulobulozni osip, pustulozni osip, makulopapularni osip, osip, svrbež, urtikarija,
Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg One tablet, once daily.
Sprječavanje HIV-a u odraslih osoba i adolescenata u dobi od 12 godina i starijih, tjelesne težine najmanje 35 kg
Cmax: ↔ Cmin: ↑ 42% (↑ 37 to ↑ 49)
Cmin: ↑ 42% (↑ 37
In a study of 498 men, the mean changes from baseline to week 24 in BMD ranged from 0.4% to 1.0% across hip, spine, femoral neck and trochanter in men who received daily emtricitabine/tenofovir disoproxil prophylaxis (n = 247) vs. placebo (n = 251).
kralježnici, vratu i trohanteru bedrene kosti u muškaraca koji su svakodnevno primali profilaksu emtricitabinom/tenofovirdizoproksilom (n = 247) u odnosu na one koji su primali placebo (n = 251).
Taking Emtricitabine/Tenofovir disoproxil Zentiva with other medicines containing didanosine
Uzimanje lijeka Emtricitabine/Tenofovir disoproxil Zentiva s drugim lijekovima koji sadrže didanozin (za liječenje HIV-infekcije): Uzimanjem lijeka Emtricitabine/Tenofovir disoproxil
No human data on the effect of emtricitabine/tenofovir disoproxil are available.
Nema podataka o učinku emtricitabina/tenofovirdizoproksila na plodnost u čovjeka.
Cmin: ↑ 51% (↑ 37 to ↑ 66)
Cmin: ↑ 51% (↑ 37 - ↑
If serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving emtricitabine/tenofovir disoproxil, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Ako su u bilo kojeg pedijatrijskog bolesnika koji prima lijek Emtricitabine/Tenofovir disoproxil Zentiva fosfati u serumu < 3,0 mg/dl (0,96 mmol/l), unutar jednog tjedna treba ponovno procijeniti funkciju bubrega, kao i izmjeriti koncentracije glukoze u krvi, kalija u krvi i glukoze u mokraći
Staggered administration (12 hours apart)
Primjena s vremenskim odmakom (12 sati razmaka) dala je slične rezultate.
Uncommon anaemia2
Manje često anemija2
There is insufficient information on the effects of emtricitabine and tenofovir in newborns/infants.
Nema dovoljno podataka o učincima emtricitabina i tenofovira za novorođenčad/dojenčad, stoga se Emtricitabine/Tenofovir disoproxil Zentiva ne bi trebalo primjenjivati tijekom dojenja.
Cmax: ↑ 47% (↑ 37 to ↑ 58) Cmin: ↑ 47% (↑ 38 to ↑ 57)
Cmin: ↑ 47% (↑ 38 - ↑
Protease inhibitors Atazanavir / ritonavir / tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Atazanavir / ritonavir / tenofovirdizoproksil (300 mg jedanput na dan / 100 mg jedanput na dan / 245 mg jedanput na dan)
Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg q.d.
Sofosbuvir/velpatasvir/ voksilaprevir (400 mg/100 mg/100 mg+100 mg jedanput na dan)3 + darunavir (800 mg jedanput na dan) + ritonavir (100 mg jedanput na dan) + emtricitabin/tenofovirdizoproksil (200 mg/300 mg jedanput na dan)
• The active substances are emtricitabine and tenofovir disoproxil phosphate.
• Djelatne tvari su emtricitabin i tenofovirdizoproksilfosfat.
Paediatrics with renal impairment Not recommended for use in individuals under the age of 18 years with renal impairment (see section
Ne preporučuje se primjena u osoba mlađih od 18 godina koje imaju oštećenje bubrega (vidjeti dio
Hepatitis C virus (HCV) antiviral agents Ledipasvir/sofosbuvir (90 mg/400 mg q.d.)
Antivirusni lijekovi za virus hepatitisa C (HCV) Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan) + atazanavir/ritonavir (300 mg jedanput na dan/100 mg jedanput na dan) + emtricitabin/tenofovirdizoproksil (200 mg/245 mg jedanput na dan)1
Seroconversions / Na Incidence per 100 person-years (95% CI) 1.99 (1.49, 2.62) Relative Risk Reduction (95% CI) a Relative risk reduction calculated for mITT cohort based on incident (post-baseline) seroconversion.
Incidencija na 100 osoba-godina (95% CI) Smanjenje relativnog rizika (95% CI)
Emtricitabine/Tenofovir disoproxil Zentiva should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
HIV-1 koji nosi mutaciju K65R, a koji su već bili liječeni antiretrovirusnim lijekovima (vidjeti dio 5.1).
Efavirenz/tenofovir disoproxil
Efavirenz/tenofovirdizoproksil
The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Sigurnost tenofovirdizoproksila prilikom istovremene primjene s ledipasvirom/sofosbuvirom i farmakokinetičkim pojačivačem (npr.
The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Sigurnost tenofovirdizoproksila prilikom istovremene primjene sa sofosbuvirom/velpatasvirom i farmakokinetičkim pojačivačem (npr.