natgillin/translations-raw huggingface dataset:
In studies in lamivudine-refractory patients, with only limited numbers of patients being followed up, 11% of entecavir-treated patients and no lamivudine-treated patients developed ALT elevations during posttreatment follow-up.
V študijah pri bolnikih, neodzivnih na lamivudin, so po prekinitvi zdravljenja spremljali le manjše število bolnikov.
Patients with decompensated liver disease: a higher rate of serious hepatic adverse events (regardless of causality) has been observed in patients with decompensated liver disease, in particular in those with Child-Turcotte-Pugh (CTP) class C disease, compared with rates in patients with compensated liver function.
Bolniki z dekompenzirano boleznijo jeter: V primerjavi z bolniki s kompenziranim delovanjem jeter so pri bolnikih z dekompenzirano boleznijo jeter opazili večji odstotek resnih jetrnih neželenih dogodkov
HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
HBeAg pozitivni (študija 022): pri zdravljenju z entekavirjem do 96 tednov (n = 354) so bili kumulativni odstotki odziva naslednji: 80% za HBV DNA < 300 kopij/ml (s PCR), 87% za normalizacijo vrednosti ALT, 31% za serokonverzijo HBeAg in 2% za serokonverzijo HBsAg (5% za izginotje HBsAg).
Adefovir Dipivoxil 10 mg once daily
1 mg enkrat na dan adefovirdipivoksil 10 mg enkrat na dan
Baseline HBV DNA < 8 log10 IU/ml Baseline HBV DNA ≥ 8 log10 IU/ml aNC=F (noncompleter=failure) * Patients randomized to placebo who did not have HBe- seroconversion by Week 48 rolled over to open-label entecavir for the second year of the study; therefore randomized comparison data are available only through Week 48.
* Bolniki, randomizirani na placebo, ki niso dosegli serokonverzije Hbe do 48. tedna, so v drugem letu študije prešli na odprto zdravljenje z entekavirjem, zato so randomizirani primerjalni podatki na voljo le do 48. tedna.
If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
Paediatric population: the steady-state pharmacokinetics of entecavir were evaluated (study 028) in 24 nucleoside naïve and 19 lamivudine-experienced HBeAg-positive paediatric subjects from 2 to < 18 years of age with compensated liver disease.
(študija 028) pri 24 z nukleozidi predhodno še nezdravljenimi in 19 z lamivudinom predhodno zdravljenimi HBeAg pozitivnimi pediatričnimi bolniki, starih od 2 do < 18 let, s kompenzirano boleznijo jeter.
Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
s kompenzirano boleznijo jeter in dokazano aktivno replikacijo virusa, persistentno povečanimi vrednostmi serumske alanin-aminotransferaze (ALT) in histološko dokazanim aktivnim vnetjem in/ali fibrozo.
Entecavir Accord 0.5 mg tablets entecavir
Entecavir Accord 0,5 mg tablete entekavir
MELD score Mean change from baselinec,e
Ocena po MELD točkovanju Povprečna sprememba od izhodiščac,e -2,0
Some patients must take Entecavir Accord on an empty stomach (see Entecavir Accord with food and drink in Section 2).
Nakateri bolniki morajo jemati zdravilo Entecavir Accord na prazen želodec (glejte Zdravilo
Therefore, in patients with both decompensated liver disease and lamivudine-resistant HBV, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy.
Pri bolnikih s potrjeno okužbo z virusom HBV, odpornim na lamivudin, je treba razmisliti o uvedbi kombiniranega zdravljenja z entekavirjem in drugim protivirusnim zdravilom (ki si ne deli navzkrižne odpornosti ne z lamivudinom ne z entekavirjem) in takšnemu zdravljenju dati prednost pred monoterapijo z entekavirjem.
- genotypic ETVr c with virologic breakthrough d a Results reflect use of a 1-mg dose of entecavir for 147 of 149 patients in Year 3 and all patients in Years 4 and 5 and of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 20 weeks for 130 of 149 patients in Year 3 and for 1 week for 1 of 121 patients in Year 4 in a rollover study.
5. letu ter kombinirano zdravljenje z entekavirjem in lamivudinom (čemur je sledilo dolgotrajno zdravljenje z entekavirjem) z mediano 20 tednov pri 130 od 149 bolnikov v 3. letu ter 1 tedna pri 1 od 121 bolnikov v 4 letu v nadaljnji študiji.
How to store Entecavir Accord
Shranjevanje zdravila Entecavir Accord
had a ≥ 2-point decrease.
Zasledili pa so manjše količine presnovkov II.
Following administration of 14C-entecavir, no oxidative or acetylated metabolites and minor amounts of the phase II metabolites, glucuronide and sulfate conjugates, were observed.
Po dajanju 14C-entekavirja niso zasledili oksidiranih ali acetiliranih presnovkov.
Entecavir Accord dosage*
Odmerjanje* zdravila Entecavir Accord
Among lamivudine-refractory patients with baseline HBV DNA < 107 log10 copies/ml, 64% (9/14)
Pri bolnikih, neodzivnih na lamivudin, z izhodiščno vrednostjo HBV DNA <107 log10 kopij/ml je bila v 48. tednu pri 64% (9/14) dosežena vrednost HBV DNA <300 kopij/ml.
Experience in patients co-infected with HIV: the safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudine-containing HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
in HBV, ki so se med protiretrovirusnem zdravljenju po režimu HAART zdravili tudi z lamivudinom, je bil varnostni profil entekavirja podoben kot pri bolnikih, okuženih le s HBV (glejte poglavje 4.4).
0.05 mg once daily* OR 0.5 mg every 5-7 days
0,5 mg vsakih 5-7 dni
There was no apparent difference in efficacy for entecavir based on gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients > 65 years of age).
Glede na spol (≈ 25% žensk v kliničnih preskušanjih) ali starost (≈ 5% bolnikov, starejših od 65 let) se učinkovitost entekavirja očitneje ne razlikuje.
ALT normalisation (≤ 1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
Ob koncu zdravljenja je 27% z entekavirjem zdravljenih in 21% z lamivudinom zdravljenih bolnikov imelo normalne vrednosti ALT (≤ 1 krat ULN).
Exacerbations during treatment: in studies with nucleoside naive patients, on treatment ALT elevations > 10 times ULN and > 2 times baseline occurred in 2% of entecavir treated patients vs 4% of lamivudine treated patients.
Poslabšanja med zdravljenjem: V študijah pri bolnikih, ki se še niso zdravili z nukleozidi, so se vrednosti ALT med zdravljenjem povečale za > 10 krat od ULN in > 2 krat od izhodiščnih vrednosti pri 2% bolnikov, ki so se zdravili z entekavirjem in 4% bolnikov, ki so se zdravili z lamivudinom.
In a small percentage of lamivudine-refractory patients, ETVr substitutions at residues rtT184, rtS202 or rtM250 were present at baseline.
Pri majhnem odstotku bolnikov, neodzivnih na lamivudin, so bile ETVr substitucije na ostankih rtT184,
Some people get very serious hepatitis symptoms when they stop taking Entecavir Accord.
Pri nekaterih bolnikih se po prekinitvi zdravljenja z zdravilom Entecavir Accord lahko pojavijo zelo resni bolezenski znaki hepatitisa.
The entecavir dosage was 0.5 mg daily in the pivotal studies (mean exposure 85 weeks) and 1 mg daily in the rollover study (mean exposure 177 weeks), and 51 patients in the rollover study initially also received lamivudine (median duration 29 weeks).
V ključnih študijah so bolniki prejemali entekavir v odmerku 0,5 mg na dan (srednji čas izpostavljenosti 85 tednov), v obnovljeni študiji pa 1 mg na dan (srednji čas izpostavljenosti
Entecavir Accord tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Entecavir Accord tablete uporabljamo tudi za zdravljenje kronične (dolgotrajne) okužbe s HBV
Therefore, therapy with entecavir should not be used for HIV/HBV co-infected patients who are not receiving HAART.
Pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki se ne zdravijo po režimu HAART, se entekavir torej ne sme uporabljati.
At end of dosing, among patients who continued treatment beyond 52 weeks (median of 96 weeks), 81% of 243 entecavir-treated and 39% of 164 lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR while ALT normalisation (≤ 1 times ULN) occurred in 79% of entecavirtreated and 68% of lamivudine-treated patients.
81% od 243 z entekavirjem zdravljenih bolnikov in 39% od 164 z lamivudinom zdravljenih bolnikov imelo HBV DNA < 300 kopij/ml (s PCR), normalne vrednosti ALT (≤ 1 krat ULN) pa 79% z entekavirjem zdravljenih in 68% z lamivudinom zdravljenih bolnikov.
Two-year carcinogenicity studies: in male mice, increases in the incidences of lung tumours were observed at exposures ≥ 4 and ≥ 2 times that in humans at 0.5 mg and 1 mg respectively.
Dvoletne študije kancerogenosti: pri mišjih samcih so opazili večjo pojavnost pljučnih tumorjev pri izpostavljenosti ≥ 4-krat od izpostavljenosti človeka pri odmerku 0,5 mg in ≥ 2-kratni izpostavljenosti človeka pri odmerku 1 mg. Pred pojavom tumorja so zasledili proliferacijo pnevmocitov, česar pa pri podganah, psih ali opicah niso opazili, kar kaže, da je ključni dogodek pri razvoju pljučnega tumorja, ki so ga opazili pri miših, lahko vrstno specifičen.
Entecavir Accord 1 mg film-coated tablets entecavir
Entecavir Accord 1 mg filmsko obložene tablete entekavir
b NC=F (noncompleter=failure), meaning treatment discontinuations before the analysis week, including reasons such as death, lack of efficacy, adverse event, noncompliance/loss-to-follow-up, are counted as failures (e.g., HBV DNA ≥ 300 copies/ml) c NC=M (noncompleters=missing) dDefined as decrease or no change from baseline in CTP score.
Vzroki za predčasno prekinitev zdravljenja so lahko smrt, pomanjkanje učinkovitosti, neželeni učinki, nesodelovanje bolnika, onemogočeno spremljanje bolnika ipd. c NC=M (bolnik, pri katerem študija ni bila dokončana=manjkajoči podatek).
*p<0.05
*p vrednost v primerjavi z lamivudinom < 0,05
Exacerbations of hepatitis: spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Pri nekaterih bolnikih se po uvedbi protivirusnega zdravljenja vrednosti serumske ALT lahko povišajo, medtem ko se vrednosti serumske HBV DNA zmanjšajo (glejte poglavje 4.8).
0.3 mg once daily* OR 0.5 mg every 48 hours
0,5 mg vsakih 48 ur
For patients with baseline Ishak fibrosis score ≥ 2, 25/43 (58%)
≥ 2-točki ugotovili pri 25/43 bolnikov (58%).
Entecavir Accord 1 mg film-coated tablets Bottle packs:
Entecavir Accord 1 mg filmsko obložene tablete Pakiranje v plastenkah:
Entecavir Accord 0.5 mg film-coated tablets
Entecavir Accord 0,5 mg filmsko obložene tablete
Entecavir Accord 0.5 mg film-coated tablets Bottle packs:
Entecavir Accord 0,5 mg filmsko obložene tablete Pakiranje v plastenkah:
Patients should be monitored closely for adverse reactions when entecavir is coadministered with such medicinal products.
Bolnike, ki se sočasno zdravijo z entekavirjem in omenjenimi zdravili, je treba skrbno nadzirati glede pojava neželenih učinkov.
Entecavir Accord 0.5 mg film-coated tablets: White to off white, triangle shaped, biconvex filmcoated tablets debossed with ‘J' on one side and ‘110' on other side.
Entecavir Accord 0,5 mg filmsko obložene tablete: bele do umazano bele barve, bikonveksne in trikotne oblike.
Elimination: entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose.
V stanju dinamičnega ravnovesja se približno 75% odmerka izloči v nespremenjeni obliki.
Pre-existing lamivudine-resistant HBV is associated with an increased risk for subsequent entecavir resistance regardless of the degree of liver disease; in patients with decompensated liver disease, virologic breakthrough may be associated with serious clinical complications of the underlying liver disease.
Že obstoječa odpornost virusa HBV proti lamivudinu je povezana z večjim tveganjem za kasnejši razvoj odpornosti proti entekavirju, ne glede na stopnjo bolezni jeter.
These trials provide experience in 195 HBeAg-positive nucleosidetreatment-naïve subjects treated with entecavir for a median duration of 99 weeks.
195 HBeAg pozitivnih bolnikih, ki se predhodno še niso zdravili z nukleozidi.
Mild
Normalen
Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)
Delež nedokazljivih (<300 kopij/ml)b
An oral solution may be available for patients with body weight less than 32.6 kg.
Pri bolnikih s telesno maso, manjšo od 32,6 kg, je treba uporabljati peroralno raztopino.
In studies in nucleoside-naive patients, 6% of entecavir-treated patients and 10% of lamivudine-treated patients experienced ALT elevations (> 10 times ULN and > 2 times reference [minimum of baseline or last end-of-dosing measurement]) during post-treatment follow-up.
študijah pri bolnikih, ki se še niso zdravili z nukleozidi, so se med spremljanjem po zdravljenju vrednosti ALT povečale (za > 10 krat od ULN in > 2 krat od referenčne vrednosti [najmanjše ob izhodišču ali zadnje, izmerjene ob prekinitvi zdravljenja]) pri 6% bolnikov, ki so se zdravili z entekavirjem in 10% bolnikov, ki so se zdravili z lamivudinom.
Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Ena tableta vsebuje 0,5 mg entekavirja v obliki entekavir monohidrata.
Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Ena tableta vsebuje 1 mg entekavirja v obliki entekavir monohidrata.
The time to onset of HCC or death (whichever occurred first) was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with entecavir and adefovir dipivoxil, respectively, and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for entecavir and adefovir dipivoxil, respectively.
Pri bolnikih, ki so se zdravili z entekavirjem, je bil kumulativni delež smrtnih izidov med študijo 23-odstoten (23/102), pri bolnikih, ki so se zdravili z adefovirdipivoksilom pa 33-odstoten (29/89).
Method of administration Entecavir Accord should be taken orally.
Zdravilo Entecavir Accord mora bolnik jemati peroralno.
Week 96 .
177 tednov).
Talk to your doctor or pharmacist before taking Entecavir Accord if you have ever had problems with your kidneys, tell your doctor.
Pred začetkom jemanja zdravila Entecavir Accord se posvetujte s svojim zdravnikom ali s farmacevtom.
Among entecavir-treated patients, on-treatment ALT elevations had a median time to onset of 4-5 weeks, generally resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10/ml reduction in viral load that preceded or coincided with the ALT elevation.
Pri bolnikih, ki so se zdravili z entekavirjem, so se poslabšanja med zdravljenjem pojavila v povprečju po 4 - 5 tednih zdravljenja in so običajno pri nadaljevanju zdravljenja izzvenela.
Liver transplant recipients: renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2).
Bolniki s presajenimi jetri: Pri bolnikih s presajenimi jetri, ki se zdravijo s ciklosporinom ali takrolimusom, je treba pred začetkom zdravljenja z entekavirjem skrbno oceniti delovanje ledvic.
Entecavir Accord 1 mg film-coated tablets: Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side.
Entecavir Accord 1 mg filmsko obložene tablete: rožnate barve, bikonveksne in trikotne oblike.
Mean serum HBV DNA by PCR was 7.83 log10 copies/ml and mean serum ALT was 100 U/l; 54% of patients were HBeAg positive, and 35% of patients had LVDr substitutions at baseline.
Srednja vrednost HBV DNA (s PCR) v izhodišču je bila 7,83 log10 kopij/ml, srednja vrednost ALT v serumu pa 100 enot/l.
Entecavir Accord 0.5 mg film-coated tablets entecavir
Entecavir Accord 0,5 mg filmsko obložene tablete entekavir
Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
Pri pediatričnih bolnikih s kompenzirano boleznijo jeter zaradi HBeAg pozitivnega kroničnega hepatitisa B mora biti serumska vrednost ALT pred uvedbo zdravljenja persistentno povečana vsaj
Package leaflet: Information for the user Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets entecavir
Navodilo za uporabo Entecavir Accord 0,5 mg filmsko obložene tablete Entecavir Accord 1 mg filmsko obložene tablete entekavir
Entecavir Accord can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Zdravilo Entecavir Accord se lahko uporablja tako pri bolnikih z okvaro jeter, ki še delujejo normalno (kompenzirana bolezen jeter),
Laboratory test abnormalities: through week 48 among entecavir-treated patients with decompensated liver disease, none had ALT elevations both > 10 times ULN and > 2 times baseline, and 1% of patients had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Odstopanja od normalnih vrednosti laboratorijskih preiskav: med 48-tedenskim zdravljenjem pri nobenem od bolnikov, ki so prejemali entekavir, niso poročali o zvišanju vrednosti ALT, ki bi bile več kot 10 krat večje od zgornje meje normalne vrednosti (ULN - Upper Limit of Normal) in sočasno več kot 2 krat večje od izhodiščnih vrednosti.
Among entecavir-treated nucleoside naive patients, post-treatment exacerbations had a median time to onset of 23-24 weeks, and most were reported in HBeAg negative patients (see section 4.8).
Pri predhodno z nukleozidi nezdravljenih bolnikih, ki so se zdravili z entekavirjem, so se poslabšanja po zdravljenju pojavila v povprečju 23 - 24 tednov po prekinitvi zdravljenja.
0.15 mg once daily* OR 0.5 mg every 72 hours
0,5 mg vsakih 72 ur
(see a. Summary of the safety profile and section 5.1)
(glejte poglavje 5.1) pri odraslih:
Bottle pack:
Pakiranje v plastenki:
Also, patients with decompensated liver disease may be at higher risk for lactic acidosis and for specific renal adverse events such as hepatorenal syndrome.
(ne glede na vzrok), še posebej pri bolnikih, ki so po Child-Turcotte-Pugh-ovi (CTP) lestvici spadali v skupino C. Pri bolnikih z dekompenzirano boleznijo jeter je večje lahko tudi tveganje za pojav laktacidoze in specifičnih neželenih učinkov na ledvicah, na primer hepatorenalnega sindroma.
Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment.
Da bi bila korist zdravila popolna, tveganje za pojav odpornosti na zdravljenje pa čim manjše, morate vedno jemati le odmerek, ki vam ga je predpisal zdravnik.
* for doses < 0.5 mg entecavir oral solution is recommended.
0,5 mg vsakih 72 ur * za odmerke < 0,5 mg priporočamo uporabo peroralne raztopine entekavirja.
Reductions in HIV RNA have been reported in HIV/HBV co-infected patients receiving entecavir monotherapy without HAART.
Pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki so se zdravili samo z entekavirjem, brez zdravljenja po režimu HAART, so poročali o zmanjšanju vrednosti HIV RNA.
Albumin levels < 2.5 g/dl occurred in 30% of patients, lipase levels > 3 times baseline in 10% and platelets < 50,000/mm3 in 20%.
Pri 10% bolnikov so bile vrednosti lipaze > 3 krat večje od izhodiščnih vrednosti, število trombocitov pa je bilo pri 20% bolnikov < 50.000/mm3.
Subjects were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
180 z nukleozidi predhodno še nezdravljenimi otroci in mladostniki, starimi od 2 do < 18 let, s HBeAg pozitivno kronično okužbo z virusom hepatitisa B, kompenzirano boleznijo jeter in povečano vrednostjo ALT. Bolnike so randomizirali (2:1) na slepo zdravljenje z entekavirjem v odmerku 0,015 mg/kg do največ 0,5 mg/dan (N = 120) ali placebo (N = 60).
At the time of the long-term biopsy, all patients had HBV DNA < 300 copies/ml and 49/57 (86%) had serum ALT ≤ 1 times ULN.
Po dolgotrajnem zdravljenju so imeli vsi bolniki v času biopsije vrednost HBV DNA < 300 kopij/ml.
3 of the 10 patients experienced virologic breakthrough (≥ 1 log10 increase above nadir).
Pri dveh od teh 3 bolnikov je prišlo do povečanja virusnega bremena (glejte preglednico).
The active substance is entecavir.
Absorpcija: Absorpcija entekavirja je hitra.
Lamivudine-refractory patients (i.e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose in adults is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Bolniki, neodzivni na lamivudin (to je z dokazano viremijo med zdravljenjem z lamivudinom ali prisotnostjo mutacij, povezanih z odpornostjo na lamivudin [LVDr]) (glejte poglavji 4.4 in 5.1):
For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Pri bolnikih, ki so od začetka prejemali entekavir, so se vrednosti HBV DNA v 48. tednu zmanjšale za -4,20 log10 kopij/ml,
*p value vs lamivudine < 0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint.
a bolniki z ovrednoteno histološko sliko v izhodišču (stopnja vnetja in nekroze po Knodell-u v izhodišču ≥ 2)
In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Pri 1% bolnikov so bile vrednosti ALT > 2 krat večje od izhodiščnih vrednosti in sočasno povečane tudi vrednosti skupnega bilirubina, ki so bile > 2 krat večje od zgornje meje normalne vrednosti in > 2 krat večje od izhodiščnih vrednosti.
- genotypic ETVrc with virologic breakthrough d
- genotipsko ETVr c s d povečanjem virusnega bremena a
Invented name Strength Pharmaceutical Form
Izmišljeno ime Jakost
Route of administration Packaging
Način uporabe zdravila
Date of first authorisation: 11 January 2008 Date of latest renewal: 11 January 2013
Datum prve odobritve: 11. januar 2008 Datum zadnjega podaljšanja: 11. januar 2013
Your doctor may therefore have to monitor the condition of your liver.
Zdravnik bo zato morda moral spremljati stanje vaših jeter.
Relationship between concentration and effect
Povezava med koncentracijo in učinkom
Difference (95 % CI)
Razlika (95 % IZ)
Swirl the vial gently.
Vialo nežno vrtite.
Elderly (≥65 years)
Starejši (≥ 65 let)
Other side effects that have been reported are listed below.
Ostali neželeni učinki o katerih so poročali so navedeni spodaj.
Pack sizes: 1 or 10 vials.
Velikost pakiranja: 1 ali 10 vial.
The safety profile of aprepitant was evaluated in approximately 6,500 adults and 184 children and adolescents.
Varnostni profil aprepitanta je bil ovrednoten pri približno 6.500 odraslih in 184 otrocih in mladostnikih.
**N: Number of adult patients included in the primary analysis of complete response.
**N: Število odraslih bolnikov vključenih v primarno analizo popolnega odziva.
NR = Not Reported
NP = ni poročano
What IVEMEND is and what it is used for
Kaj je zdravilo IVEMEND in za kaj ga uporabljamo