natgillin/translations-raw huggingface dataset:
Tell your doctor if any of the following applies: you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this you have a current or previous infection with the hepatitis B virus, since your doctor may want to your liver is damaged and not functioning properly (decompensated liver disease) you have diabetes.
Povejte zdravniku, če se kar koli od naslednjega nanaša na vas: jemljete ali ste v zadnjih nekaj mesecih jemali zdravilo amiodaron za zdravljenje nerednega srčnega utripa (če jemljete ali ste jemali to zdravilo, bo zdravnik morda razmislil o drugih če imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno če imate okvaro jeter, zaradi katere jetra ne delujejo pravilno (dekompenzirana bolezen jeter).
Because daclatasvir is highly protein bound (99%) and has a molecular weight >500, dialysis is unlikely to significantly reduce plasma concentrations of daclatasvir.
Ker se daklatasvir močno veže na beljakovine (99 %), njegova molekulska masa pa je > 500, je malo verjetno, da bi dializa pomembneje zmanjšala koncentracije
The most frequently reported adverse reactions were fatigue, headache, and nausea.
Najpogosteje poročani neželeni učinki so bili utrujenost, glavobol in navzea.
SVR12 was achieved by 83% (50/60) of patients in the cirrhosis cohort, with a marked difference between patients with Child-Pugh A or B (92-94%) as compared to those with Child-Pugh C and 94% of patients in the post-liver transplant cohort (Table 9).
SVR12 je bil dosežen pri 83 % (50/60) bolnikov v kohorti s cirozo, z izrazito razliko med bolniki s Child-Pugh A ali B (92-94 %) v primerjavi z bolniki s Child-Pugh C in pri 94 % bolnikov v kohorti po presaditvi jeter (tabela 9).
Patients with HCV infection (across genotypes) at high risk of decompensation or death within 12 months if left untreated were treated under compassionate use programmes.
Bolnike z okužbo s HCV (kateri koli genotip) in visokim tveganjem za dekompenzacijo ali smrt v 12 mesecih brez zdravljenja so zdravili v programih sočutne uporabe zdravila.
Concerning recommended regimens with different HCV genotypes, see section 4.2.
Za priporočene režime pri različnih genotipih HCV glejte poglavje 4.2.
Following single-dose oral administration of 14C-daclatasvir in healthy subjects, 88% of total radioactivity was recovered in feces (53% as unchanged drug) and 6.6% was excreted in the urine (primarily as unchanged drug).
Po enkratnem peroralnem odmerku z radioaktivnim izotopom 14C označenega daklatasvirja se je pri zdravih osebah 88 % celotne radioaktivnosti izločilo z blatom (53 % v obliki nespremenjenega zdravila), 6,6 % pa z urinom (v glavnem v nespremenjeni obliki).
No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective
Klinično pomembne protivirusne aktivnosti proti različnim RNA in DNA virusom, vključno z virusom HIV, niso opazili, kar potrjuje, da je daklatasvir, ki zavira za HCV specifično tarčo, zelo selektiven za HCV.
General disorders and administration site conditions fatigue
Splošne težave in spremembe na mestu aplikacije utrujenost
↔ Daclatasvir AUC: ↔*
↔ Daklatasvir AUC: ↔*
The pharmacokinetics of daclatasvir in paediatric patients have not been evaluated.
Farmakokinetike daklatasvirja pri pediatričnih bolnikih niso vrednotili.
If you accidentally take more Daklinza tablets than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Če ste vzeli večji odmerek zdravila Daklinza, kot bi smeli Če ste pomotoma vzeli več tablet zdravila Daklinza kot bi smeli, se nemudoma posvetujte s svojim zdravnikom ali poiščite zdravniško pomoč v najbližji bolnišnici.
In vitro and in vivo studies demonstrate that daclatasvir is a substrate of CYP3A, with CYP3A4 being the major CYP isoform responsible for the metabolism.
In vitro ter in vivo študije kažejo, da je daklatasvir substrat za CYP3A, pri čemer je CYP3A4 glavna izooblika CYP, odgovorna za presnovo.
EU/1/14/939/001 28 tablets (calendar pack)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/001 28 tablet (koledarsko pakiranje)
Cirrhotic cohort N=60
Kohorta s cirozo N=60
The efficacy and safety of daclatasvir 60 mg once daily in combination with sofosbuvir 400 mg once daily in the treatment of patients with chronic HCV infection were evaluated in five open-label studies (AI444040, ALLY-1, ALLY-2, ALLY-3, and ALLY-3C).
Učinkovitost in varnost daklatasvirja v odmerku 60 mg enkrat na dan v kombinaciji s sofosbuvirjem v odmerku 400 mg enkrat na dan pri zdravljenju bolnikov s kronično okužbo s HCV so vrednotili v petih odprtih študijah (AI444040, ALLY-1, ALLY-2, ALLY-3 in ALLY-3C).
Total N=78
Skupaj N=78
In phase 1 clinical studies, healthy subjects who received up to 100 mg once daily for up to 14 days or single doses up to 200 mg had no unexpected adverse reactions.
V kliničnih študijah 1. faze uporaba odmerkov do 100 mg enkrat na dan v trajanju 14 dni ali enkratnih odmerkov do 200 mg pri zdravih osebah ni bila povezana s pojavom nepričakovanih neželenih
What Daklinza looks like and contents of the pack
Izgled zdravila Daklinza in vsebina pakiranja
In vitro daclatasvir is an inhibitor of renal uptake transporters, OAT1 and 3, and OCT2, but is not expected to have a clinical effect on the pharmacokinetics of substrates of these transporters.
Daklatasvir je in vitro zaviralec ledvičnih prenašalcev privzema, OAT1 in 3 ter OCT2, vendar pa kliničnega učinka na farmakokinetiko substratov za te prenašalce ne
EU/1/14/939/003 28 tablets (calendar pack)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/003 28 tablet (koledarsko pakiranje)
NARCOTIC ANALGESICS Buprenorphine/naloxone, 8/2 mg to 24/6 mg once daily
NARKOTIČNI ANALGETIKI Buprenorfin/nalokson, od 8/2 mg do 24/6 mg enkrat na
Close monitoring of INR values is recommended with all vitamin K antagonists.
Pri vseh antagonistih vitamina K se priporoča natančno spremljanje vrednosti INR.
This medicine contains less than 1 mmol sodium (23 mg) per maximum dose of 90 mg, that is to say
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na največji odmerek 90 mg, kar v bistvu pomeni
All patients receiving Daklinza and sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Vse bolnike, ki prejemajo zdravilo Daklinza in sofosbuvir v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško
Daclatasvir was excreted into the milk of lactating rats with concentrations 1.7- to 2-fold maternal
Daklatasvir se je izločal v mleko doječih podgan v koncentracijah, ki so bile od 1,7-krat do 2-krat
Due to the lack of data, coadministration of Daklinza and etravirine or nevirapine is not recommended.
Zaradi pomanjkanja podatkov sočasna uporaba zdravila Daklinza in etravirina ali nevirapina ni priporočljiva.
No metabolites circulated at levels more than 5% of the parent concentration.
Ugotovljena količina presnovkov v obtoku ni presegala 5 % koncentracije izhodne učinkovine.
** Other non-responders included 4 patients with HCV RNA < LLOQ target not detected (TND) at end of treatment, but who were lost to follow-up at post-treatment Week 12 and subsequent time points, and 1 patient who had no on-treatment HCV RNA results due to early discontinuation.
** Neuspeh iz drugih razlogov vključuje 4 bolnike, pri katerih ciljna vrednost HCV RNA < LLOQ ob koncu zdravljenja ni bila dokazana (target not detected - TND), vendar pa 12. teden po koncu zdravljenja in v vseh kasnejših časovnih točkah niso bili na voljo za spremljanje, in 1 bolnika, pri katerem rezultati HCV RNA med zdravljenjem zaradi zgodnjega prenehanja zdravljenja niso bili znani.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bristol-Myers Squibb Pharma EEIG
The safety and efficacy of Daklinza in children and adolescents aged below 18 years have not yet been
Varnost in učinkovitost zdravila Daklinza pri otrocih in mladostnikih, mlajših od 18 let, še nista bili
Very common (may affect more than 1 in 10 people): headache, nausea (feeling sick), fatigue reduction in red blood cells (anaemia) Common (may affect up to 1 in 10 people):
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): glavobol, navzea (siljenje na bruhanje), utrujenost zmanjšanje števila rdečih krvnih celic (anemija)
The SVR12 rates were achieved by 88.5% of patients, including 92.6% of treatment-naïve and 79.2% of treatment-experienced patients (see Table 13).
SVR12 je bil dosežen pri 88,5 % bolnikov, vključno z 92,6 % pri predhodno še nezdravljenih bolnikih in 79,2 % pri predhodno že zdravljenih bolnikih (glejte tabelo 13).
HCV RNA values in the ALLY-3C (AI444379) study were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test (version 2.0), with an LLOQ of 15 IU/mL.
V študiji ALLY-3C (AI444379) so vrednosti HCV RNA izmerili s testom Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV (različica 2.0), z LLOQ 15 i.e./ml.
In the majority of clinical studies of daclatasvir in combination with sofosbuvir or with peginterferon alfa and ribavirin, plasma HCV RNA values were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, with a lower limit of quantification (LLOQ) of 25 IU/ ml.
V večini kliničnih študij daklatasvirja v kombinaciji s sofosbuvirjem ali peginterferonom alfa in ribavirinom, so vrednosti HCV RNA v plazmi izmerili s testom COBAS TaqMan HCV (različica 2.0) v visoko prečiščenem sistemu, s spodnjo mejo kvantifikacije (LLOQ - lower limit of quantification) 25 i.e./ml.
daclatasvir monotherapy for 14 days.
monoterapiji 14 dni.
Grade 3/4 increases in total bilirubin were observed in 5% of patients (all in patients with HIV coinfection who were receiving concomitant atazanavir, with Child-Pugh A, B, or C cirrhosis, or who
O povečanju vrednosti skupnega bilirubina stopnje 3/4 so poročali pri 5 % bolnikov (vsa ta povečanja so bila pri bolnikih s sočasno okužbo z virusom HIV, ki so sočasno prejemali atazanavir, s cirozo Child-Pugh A, B ali C ali po presaditvi
The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are
Mejne vrednosti HCV RNA, ki so razlog za ukinitev zdravljenja (pravila za ukinitev zdravljenja), so predstavljena v tabeli 3.
HCV replicons expressing daclatasvir-associated resistance substitutions remained fully sensitive to interferon alfa and other anti-HCV agents with different mechanisms of action, such as NS3 protease and NS5B polymerase (nucleoside and non-nucleoside) inhibitors.
Replikoni HCV s substitucijami, povezanimi z odpornostjo proti daklatasvirju, so ostali popolnoma občutljivi za interferon alfa in druga zdravila proti HCV, ki imajo drugačen mehanizem delovanja, kot so zaviralci proteaze NS3 in zaviralci polimeraze NS5B (nukleozidni in nenukleozidni).
* Patients who had missing data at follow-up Week 12 were considered responders if their next available HCV RNA value was <LLOQ.
* Bolniki z manjkajočim podatkom pri obisku v 12. tednu so bili obravnavani kot bolniki z odzivom, če je bila naslednja razpoložljiva vrednost HCV RNA manjša od LLOQ.
Table 4: Interactions and dose recommendations with other medicinal products Medicinal products by therapeutic areas
Tabela 4: Interakcije in priporočila za odmerjanje pri sočasni uporabi drugih zdravil Zdravila po terapevtskih področjih
The efficacy of Daklinza as part of a retreatment regimen in patients with prior exposure to a NS5A
Učinkovitosti zdravila Daklinza kot del režima ponovne uvedbe zdravljena pri bolnikih, predhodno zdravljenih z zaviralcem NS5A, niso ugotovili.
Daclatasvir is an inhibitor of nonstructural protein 5A (NS5A), a multifunctional protein that is an essential component of the HCV replication complex.
Daklatasvir je zaviralec nestrukturne beljakovine 5A (NS5A), multifunkcijske beljakovine, ki je bistveni sestavni del replikacijskega kompleksa HCV. Daklatasvir zavira tako replikacijo virusne RNA
In patients who received daclatasvir 60 mg tablet orally followed by 100 μg [
Pri bolnikih, ki so peroralno prejeli 60-mg tableto daklatasvirja, ki ji je sledil intravenski 100-μg odmerek [
Expected due to inhibition of P-gp by
Pričakovano zaradi zaviranja P-gp z
SVR12 rates were consistently high across most subgroups including gender, age, race, baseline HCV RNA, and IL28B genotype.
Delež SVR12 je bil konsistentno visok v večini podskupin, vključno glede na spol, starost, raso, izhodiščno vrednost HCV RNA in genotip IL28B.
Population pharmacokinetic analysis of data from clinical studies identified race (categories “other” [patients who are not white, black or Asian] and “black”) as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) and apparent volume of distribution (Vc/F) resulting in slightly higher exposures compared to white patients, but the magnitude of the effect on daclatasvir
Analiza podatkov populacijske farmakokinetike iz kliničnih študij kaže, da je rasa (kategoriji “drugi” [bolniki, ki niso belci, črnci ali Azijci] in “črni”) statistično pomembna kovariata za navidezni peroralni očistek daklatasvirja (CL/F) in navidezni volumen porazdelitve (Vc/F), pri čemer so bile izpostavljenosti nekoliko višje v primerjavi z bolniki bele rase, obseg učinka na izpostavljenost daklatasvirju pa ni bil klinično pomemben.
4.2 Posology and method of administration Treatment with Daklinza should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Zdravljenje z zdravilom Daklinza mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa C.
It is used to treat adults with hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Daklatasvir uporabljamo za zdravljenje odraslih s hepatitisom C. Hepatitis C je nalezljiva bolezen, ki prizadene jetra in je posledica okužbe z
Treatment outcomes in study AI444010 for patients with HCV genotype 4 are presented in Table 14.
Izidi zdravljenja v študiji AI444010 pri bolnikih z genotipom 4 HCV so prikazani v tabeli 14.
Among 258 patients who achieved SVR12 with daclatasvir and sofosbuvir (± ribavirin) with a median duration of post-SVR12 follow-up of 38 months, no relapses occurred (with relapses defined as confirmed or last available HCV RNA ≥ LLOQ).
Pri 258 bolnikih, ki so pri zdravljenju z daklatasvirjem in sofosbuvirjem (± ribavirin) dosegli SVR12, 38 mesecev (mediana vrednost trajanja spremljanja) po-SVR12 ni prišlo do ponovitve (ponovitev je bila opredeljena kot potrjena ali zadnja znana vrednost HCV RNA ≥ LLOQ).
Daclatasvir in combination with peginterferon alfa and ribavirin AI444042 and AI444010 were randomised, double-blind studies that evaluated the efficacy and safety of daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV) in the treatment of chronic HCV infection in treatment-naïve adults with compensated liver disease (including cirrhosis).
Daklatasvir v kombinaciji s peginterferonom alfa in ribavirinom Študiji AI444042 in AI444010 sta bili randomizirani, dvojno slepi študiji, ki sta vrednotili učinkovitost in varnost daklatasvirja v kombinaciji s peginterferonom alfa in ribavirinom (pegIFN/RBV) pri zdravljenju kronične okužbe s HCV pri predhodno še nezdravljenih odraslih s kompenzirano boleznijo jeter (vključno s cirozo).
Frequency of baseline NS5A resistance-associated variants (RAVs) Baseline NS5A RAVs were frequently observed in clinical studies of daclatasvir.
Pogostnost RAV NS5A (RAV - resistance-associated variants) v izhodišču V kliničnih študijah daklatasvirja so v izhodišču pogosto opazili RAV NS5A.
Daklinza 30 mg and 60 mg film-coated tablets are available in packs of 28 tablets in non-perforated calendar blisters and perforated unit dose blisters.
Daklinza 30 mg in 60 mg filmsko obložene tablete so na voljo v pakiranjih po 28 tablet v neperforiranih koledarskih pretisnih omotih in perforiranih enoodmernih pretisnih omotih.
SVR12 was achieved by 74% of patients in this study (genotype 1a: 70%, genotype 1b: 79%).
V tej študiji je bil SVR12 dosežen pri 74 % bolnikov (genotip 1a:
SVR was the primary endpoint to determine the HCV cure rate, which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12) for studies AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), ALLY-3C (AI444379), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study
Trajen virološki odziv (SVR - sustained virologic response) je bil primarni opazovani dogodek za določitev deleža ozdravitve HCV in je bil v študijah AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), ALLY-3C (AI444379), AI444042 in AI444043 opredeljen kot vrednost HCV RNA, manjša od LLOQ v 12. tednu po koncu zdravljenja (SVR12), v študiji AI444010 pa kot nezaznavna raven HCV RNA v 24. tednu po koncu zdravljenja (SVR24).
Table 15: Summary of noted newly emergent HCV NS5A substitutions on treatment or during follow-up in treated non-SVR12 subjects infected with HCV genotypes 1
Tabela 15: Povzetek opaženih novih pojavov substitucij NS5A HCV med zdravljenjem ali spremljanjem pri zdravljenih bolnikih brez SVR12, okuženih z genotipi 1 do
decreased appetite insomnia, irritability insomnia headache dizziness, migraine dizziness, migraine
zmanjšanje apetita nespečnost, razdražljivost nespečnost glavobol omotica, migrena omotica, migrena vročinski oblivi
Maternal toxicity including mortality, abortions, adverse clinical signs, decreases in body weight and food consumption was noted in both species at exposures 25-fold (rat) and 72-fold (rabbit) the clinical AUC exposure.
Toksičnost za matere je vključevala pogine, splave, neželene klinične znake, zmanjšanje telesne mase in manjše uživanje hrane, kar so opazili pri obeh vrstah pri izpostavljenosti, ki so bile na osnovi vrednosti AUC 25-krat (podgane) in 72-krat (kunčice) večje od izpostavljenosti
Table 8: Demographics and main disease characteristics in Study ALLY-1 Cirrhotic cohort N = 60
Tabela 8: Demografske lastnosti bolnikov in glavne značilnosti bolezni v študiji ALLY-1 Kohorta s cirozo
At the 60 mg dose, exposure to daclatasvir was similar between healthy subjects and HCV-infected patients.
Pri uporabi 60 mg odmerka je bila izpostavljenost daklatasvirju pri zdravih osebah in bolnikih, okuženih s HCV,
60 mg tablet orally followed by 100 μg [13C,15N]-daclatasvir intravenous dose, estimated volume of distribution at steady state was 47 l. In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes.
100-μg odmerek [13C,15N]-daklatasvirja, je ocenjeni volumen porazdelitve v stanju dinamičnega ravnovesja znašal 47 l. In vitro študije kažejo, da daklatasvir aktivno in pasivno prehaja v hepatocite.
Table 10: Demographics and baseline characteristics in Study ALLY-2 daclatasvir + sofosbuvir 12 weeks N = 153
Tabela 10: Demografske in izhodiščne lastnosti v študiji ALLY-2 daklatasvir + sofosbuvir 12 tednov N = 153
However, as this is a limited effect, dose adjustment of concomitantly administered CYP3A4 substrates is not necessary.
Zaradi tega omejenega učinka pri sočasni uporabi substratov za CYP3A4 njihovega odmerka ni treba prilagajati.
When Daklinza is used together with sofosbuvir (without ribavirin), the following side effects have
Pri uporabi zdravila Daklinza skupaj s sofosbuvirjem (brez ribavirina) so poročali o naslednjih
The daclatasvir EC50 values in the replicon system were 0.003-1.25 nM for genotypes 3a, 4a, 5a and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for infectious genotype 2a (JFH-1) virus.
Vrednosti EC50 daklatasvirja v sistemih replikona za genotipe 3a, 4a, 5a in 6a znašajo 0,003-1,25 nM, za genotip 2a 0,034-19 nM, za kužni genotip 2a
Glucose levels of diabetic patients initiating DAA therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Pri sladkornih bolnikih, ki so se začeli zdraviti z neposredno delujočim protivirusnim zdravilom, je treba zlasti v prvih treh mesecih skrbno spremljati ravni krvnega sladkorja ter po potrebi prilagoditi zdravilo za zdravljenje sladkorne bolezni.
HCV Treatmentexperienced* N=52
HCV, predhodno zdravljenje* N=52
nausea (feeling sick), diarrhoea, abdominal pain joint pain, aching or tender muscles, not caused by exercise When Daklinza is used together with sofosbuvir and ribavirin, the following side effects have been
navzea (siljenje na bruhanje), driska, bolečina v trebuhu bolečina v sklepih, bolečina ali občutljivost v mišicah, ki nista posledica telesne aktivnosti Pri uporabi zdravila Daklinza skupaj s sofosbuvirjem in z ribavirinom so poročali o naslednjih neželenih učinkih:
For dosing recommendations with HIV antiviral agents, refer to section 4.5.
Za priporočila za odmerjanje skupaj s protivirusnimi zdravili proti HIV glejte poglavje 4.5.
Daklinza must always be used together with other medicines against hepatitis C infection and must
Zdravilo Daklinza je treba vedno uporabljati skupaj z drugimi zdravili proti okužbi z virusom hepatitisa C in se ga nikoli ne sme uporabljati samega.
The active transport is mediated by OCT1 and other unidentified uptake transporters, but not by organic anion transporter (OAT) 2, sodium-taurocholate cotransporting
Aktivni transport poteka s pomočjo OCT1 in z drugimi neznanimi prenašalci privzema, ne pa tudi s prenašalcem organskih anionov (OAT - organic anion transporter) 2, polipeptidnim soprenašalcem za natrijev tavroholat (NTCP - sodium-taurocholate cotransporting polypeptide) ali polipeptidnimi prenašalci organskih anionov (OATP - organic anion transporting polypeptide).
For patients with Child-Pugh A, B, or C cirrhosis or recurrence of HCV infection after liver transplantation, the recommended initial dose of ribavirin is 600 mg daily with food.
Priporočeni začetni odmerek ribavirina pri bolnikih s cirozo Child-Pugh A, B ali C ali ponovitvijo okužbe s HCV po presaditvi jeter je 600 mg na dan skupaj s hrano.
The overall median HCV RNA was 6.38 log10 IU/mL; the majority of patients (59%) had IL-28B rs12979860 non-CC genotypes.
Mediana skupna vrednost HCV RNA je bila 6,38 log10 i.e./ml, večina bolnikov (59 %) pa je imela ne-CC genotipe IL-28B rs12979860.
This is due to liver function that may change during treatment with Daklinza.
Razlog za to so možne spremembe delovanja jeter pri zdravljenju z zdravilom Daklinza.
The Cmax and AUC of total daclatasvir (free and protein-bound drug) were lower in subjects with hepatic impairment; however, hepatic impairment did not have a clinically significant effect on the free drug concentrations of daclatasvir
Vrednosti Cmax in AUC skupnega daklatasvirja (prosto in na beljakovine vezano zdravilo) so bile pri bolnikih z okvaro jeter manjše, vendar pa okvara jeter ni imela klinično pomembnega učinka na proste koncentracije daklatasvirja (glejte poglavje 4.2).
SVR12 rates were higher for patients with the IL-28B CC genotype than for those with non-CC genotypes and for patients with baseline HCV RNA less than 800,000 IU/ml but consistently higher in the daclatasvir-treated patients than for placebo-treated
Pri bolnikih s CC genotipi IL-28B so bili deleži SVR12 višji kot pri bolnikih z ne-CC genotipi in bolnikih z izhodiščno vrednostjo HCV RNA manjšo od 800.000 i.e./ml, vendar v vseh podskupinah dosledno višji pri bolnikih, ki so se zdravili z daklatasvirjem, kot pri bolnikih, ki so prejemali placebo.
Caution should be used when Daklinza is coadministered with rosuvastatin or other substrates of OATP 1B1 or BCRP.
Pri sočasni uporabi zdravila Daklinza in rosuvastatina ali drugih substratov za OATP 1B1 ali BCRP je potrebna previdnost.
Treatmentexperienced N=24
Predhodno že zdravljeni N=24