natgillin/translations-raw huggingface dataset:
Population pharmacokinetic analysis identified gender as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) with female subjects having slightly lower CL/F, but the magnitude of the effect on daclatasvir exposure is not clinically important.
Analiza populacijske farmakokinetike je pokazala, da je spol statistično pomembna kovariata za navidezni peroralni očistek daklatasvirja (CL/F), pri čemer je bila vrednost CL/F pri ženskah nekoliko nižja, obseg učinka na izpostavljenost daklatasvirju pa ni bil klinično pomemben.
8 weeks therapy
8-tedensko zdravljenje
5.3 Preclinical safety data
5.3 Predklinični podatki o varnosti Toksičnost
Your doctor may need to adjust the dose of Daklinza or you may not be able to take Daklinza with certain medicines.
Zdravnik bo odmerek zdravila Daklinza morda moral prilagoditi ali pa zdravila Daklinza skupaj z nekaterimi drugimi zdravili ne boste smeli jemati.
Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Zdravilo Daklinza je v kombinaciji z drugimi zdravili indicirano za zdravljenje kronične okužbe z virusom hepatitisa C (HCV - hepatitis C virus) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
Daclatasvir was excreted into the milk of lactating rats with concentrations 1.7- to 2-fold maternal plasma levels.
Daklatasvir se je izločal v mleko doječih podgan v koncentracijah, ki so bile od 1,7-krat do 2-krat večje od vrednosti v plazmi matere.
These data indicate that the liver is the major clearance organ for daclatasvir in humans.
Ti podatki kažejo, da se daklatasvir pri ljudeh v največji meri izloča preko jeter.
SVR rates were comparable regardless of age, race, gender, IL28B allele status, or baseline HCV RNA level.
Deleži SVR so bili primerljivi ne glede na starost, raso, spol, status alela IL28B ali izhodiščno vrednost HCV RNA.
Psychiatric disorders common insomnia, irritability insomnia
Psihiatrične motnje pogosti nespečnost, razdražljivost nespečnost
Total N=152
Skupaj N=152
Daklinza must be administered in combination with other medicinal products for the treatment of chronic HCV infection (see sections 4.1 and 4.2).
Zdravilo Daklinza je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje kronične okužbe s HCV (glejte poglavji 4.1 in 4.2).
Patients with HCV genotype 1, 2, 3, 4, 5 or 6 infection were eligible to enroll.
Bolniki z okužbo z genotipom 1, 2, 3, 4, 5 ali 6 HCV so izpolnjevali pogoje za vključitev.
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 (JFH-1) virusa pa 0,020 nM.
Response was rapid (viral load at Week 4 showed that more than 97% of patients responded to therapy), and was not influenced by HCV subtype (1a/1b), IL28B genotype, or use of ribavirin.
Odziv je bil hiter (virusno breme v 4. tednu je pokazalo, da se je na zdravljenje odzvalo več kot 97 % bolnikov), podtip HCV (1a/1b), genotip IL28B ali uporaba ribavirina pa na odziv niso vplivali.
Patients received daclatasvir 60 mg once daily, sofosbuvir 400 mg once daily, and ribavirin (600 mg starting dose) for 12 weeks and were monitored for 24 weeks post treatment.
Bolniki so 12 tednov prejemali daklatasvir v odmerku 60 mg enkrat na dan, sofosbuvir v odmerku 400 mg enkrat na dan in ribavirin (začetni odmerek 600 mg), po zdravljenju pa so jih nadzirali še 24 tednov.
* Evaluated in opioid-dependent adults on stable methadone maintenance therapy.
* Ovrednoteno pri od opioidov odvisnih odraslih na vzdrževalnem zdravljenju s stabilnim odmerkom metadona.
SVR rates were comparable regardless of HIV regimen, age, race, gender, IL28B allele status, or baseline HCV RNA level.
Deleži SVR so bili primerljivi ne glede na režim HIV, starost, raso, spol, status alela IL28B ali izhodiščno vrednost HCV RNA.
Daclatasvir Cmax, AUC, and Cmin increased in a near dose-proportional manner.
Vrednosti Cmax, AUC in Cmin daklatasvirja se povečujejo skoraj sorazmerno z odmerkom.
and you notice 20 hours or more after the time you usually take Daklinza, wait and take the next dose at your usual time.
in je od običajnega časa, ko vzamete zdravilo Daklinza, minilo že 20 ur ali več, počakajte in vzemite naslednji odmerek ob običajnem času.
The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient infected with genotype 3.
Substitucija S282T, povezana z odpornostjo proti sofosbuvirju, se je pojavila le pri 1 bolniku, okuženem z genotipom 3, pri katerem SVR12 ni bil dosežen.
These medicines lower the effect of Daklinza so your treatment will not work.
Ta zdravila zmanjšajo učinek zdravila Daklinza, zato zdravljenje z njim ne bo uspešno.
It is therefore very important that you (or your partner) do not become pregnant during this treatment.
Če se zdravite (ali se vaš partner zdravi) s tem zdravilom, je zelo pomembno, da med zdravljenjem s tem zdravilom ne zanosite.
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.
Biotransformacija In vitro ter in vivo študije kažejo, da je daklatasvir substrat za CYP3A, pri čemer je CYP3A4 glavna izooblika CYP, odgovorna za presnovo.
Treatment week 24: ≥25 IU/ml
24. teden zdravljenja: ≥ 25 i.e./ml
HCV/HBV (hepatitis B virus) co-infection
Sočasna okužba s HCV/HBV (virus hepatitisa B)
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 were post-liver transplant).
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 jeter).
The safety and efficacy of Daklinza in the treatment of HCV infection in patients with Child-Pugh C liver disease have been established in the clinical study ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin for 12 weeks); however, SVR rates were lower than in patients with Child-Pugh A and B. Therefore, a conservative treatment regimen of Daklinza + sofosbuvir +/- ribavirin for 24 weeks is proposed for patients with Child-Pugh C (see sections 4.2 and 5.1).
Varnost in učinkovitost zdravila Daklinza pri zdravljenju okužbe s HCV pri bolnikih z boleznijo jeter Child-Pugh C so ugotovili v klinični študiji ALLY-1 (AI444215, zdravilo Daklinza + sofosbuvir + ribavirin 12 tednov), vendar pa so bili deleži SVR manjši kot pri bolnikih s Child-Pugh A in B. Pri bolnikih s Child-Pugh C je tako priporočen konzervativen režim zdravljenja, to je zdravilo Daklinza + sofosbuvir +/- ribavirin 24 tednov (glejte poglavji 4.2 in 5.1).
Interactions with medicinal products
Interakcije z zdravili
At steady state, protein binding of daclatasvir in HCV-infected patients was approximately 99% and independent of dose at the dose range studied (1 mg to 100 mg).
Pri s HCV okuženih bolnikih je vezava daklatasvirja na beljakovine v stanju dinamičnega ravnovesja znašala približno 99 % in v razponu preiskovanih odmerkov (1 mg do 100 mg) ni bila odvisna od odmerka.
Daklinza 30 mg, 60 mg and 90 mg film-coated tablets are available in packs of 28 tablets in nonperforated calendar blisters and perforated unit dose blisters.
Daklinza 30 mg, 60 mg in 90 mg filmsko obložene tablete so na voljo v pakiranjih po 28 tablet v neperforiranih koledarskih pretisnih omotih in perforiranih enoodmernih pretisnih omotih.
Daklinza should not be used during pregnancy or in women of childbearing potential not using contraception (see section 4.4).
Zdravila Daklinza ne smete uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (glejte poglavje 4.4).
Response was rapid (viral load at Week 4 showed that more than 95% of patients responded to therapy) and was not influenced by IL28B genotype.
Odziv je bil hiter (virusno breme v 4. tednu je pokazalo, da se je na zdravljenje odzvalo več kot 95 % bolnikov), genotip IL28B pa na odziv ni vplival.
Daclatasvir is an inhibitor of P-gp, organic anion transporting polypeptide (OATP) 1B1, OCT1 and breast cancer resistance protein (BCRP).
Daklatasvir je zaviralec P-gp, polipeptidnega prenašalca organskih anionov (OATP - organic anion transporting polypeptide) 1B1, OCT1 in rezistentnega proteina pri raku dojke (BCRP - breast cancer resistance protein).
Caution should be used if the medicinal product has a narrow therapeutic range (see Table 4).
Previdnost je potrebna pri uporabi zdravil z ozkim terapevtskim indeksom (glejte tabelo 4).
Peginterferon alfa 180 µg once weekly and ribavirin 1000 mg or 1200 mg/day in two divided doses (daclatasvir 60 mg once daily)
Peginterferon alfa 180 µg enkrat na teden in ribavirin 1.000 mg ali 1.200 mg/dan v obliki dveh deljenih odmerkov (daklatasvir 60 mg enkrat na dan)
Paediatric population The pharmacokinetics of daclatasvir in paediatric patients have not been evaluated.
Farmakokinetike daklatasvirja pri pediatričnih bolnikih niso vrednotili.
The European Medicines Agency has deferred the obligation to submit the results of studies with daclatasvir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z daklatasvirjem za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C
Lamivudine Zidovudine Emtricitabine Abacavir Didanosine Stavudine
Lamivudin Zidovudin Emtricitabin Abakavir Didanozin Stavudin
SVR12 was achieved by 99% patients with HCV genotype 1, 96% of those with genotype 2 and 89% of those with genotype 3 (see Tables 6 and 7).
SVR12 je bil dosežen pri 99 % bolnikov z genotipom 1 HCV, 96 % bolnikov z genotipom 2 HCV in 89 % bolnikov z genotipom 3 HCV (glejte tabeli 6 in 7).
You should not breastfeed during treatment with Daklinza.
Med zdravljenjem z zdravilom Daklinza ne smete dojiti.
> 8.5 to ≤10 g/dL
> 8,5 do ≤ 10 g/dl
Strong or moderate inducers of CYP3A4 and P-gp may decrease the plasma levels and therapeutic effect of daclatasvir.
Močni ali zmerni induktorji CYP3A4 in P-gp lahko zmanjšajo vrednosti daklatasvirja v plazmi in njegov terapevtski učinek.
All N=41
Vsi N=41
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), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study AI444010.
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), 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).
No human data on the effect of daclatasvir on fertility are available.
O vplivu daklatasvirja na plodnost človeka ni podatkov.
CP A CP B CP C Genotype 1 1a 1b Genotype 2 Genotype 3 Genotype 4 Genotype 6 ND: Not determined * 2 patients had detectable HCV RNA at end of treatment; 1 of these patients achieved SVR.
CP A CP B CP C Genotip 1 1a 1b Genotip 2 Genotip 3 Genotip 4 Genotip 6 ND: ni bilo določeno * 2 bolnika sta ob koncu zdravljenja imela zaznavno raven HCV RNA.
> 10 to ≤12 g/dL
> 10 do ≤ 12 g/dl
Developmental toxicity consisted of increased embryofoetal lethality, reduced foetal body weights and increased incidence of foetal malformations and variations.
Toksični učinki za razvoj so vključevali večjo smrtnost zarodkov in plodov, manjšo telesno maso zarodkov in večjo pojavnost malformacij in odstopanj pri zarodkih.
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.
Navzkrižna odpornost 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).
Daklinza can be taken with or without a meal.
Zdravilo Daklinza lahko jemljete skupaj s hrano ali brez nje.
In case of non-response to therapy with daclatasvir + peginterferon alfa + ribavirin, NS5A RAVs generally emerged at failure (139/153 genotype 1a and 49/57 genotype 1b).
V primeru neodzivnosti na zdravljenje s kombinacijo daklatasvir + peginterferon alfa + ribavirin, so se običajno pojavile RAV NS5A ob neuspehu (139/153 pri genotipu 1a in 49/57 pri genotipu 1b).
Treatment week 12: ≥25 IU/ml
12. teden zdravljenja: ≥ 25 i.e./ml
Protease inhibitors (PIs) Boceprevir
Zaviralci proteaz (PI-ji) Boceprevir
The lowest dose of digoxin should be initially prescribed.
Zdravljenje z digoksinom je treba uvesti v najmanjšem možnem odmerku.
Daklinza is given for 24 weeks, in combination with 24-48 weeks of peginterferon alfa and ribavirin: - If HCV RNA is undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for a total duration of 24 weeks.
Zdravilo Daklinza se uporablja 24 tednov v kombinaciji s 24-48 tedni zdravljenja s peginterferonom alfa in z ribavirinom: - Če je raven HCV RNA nezaznavna tako v 4. kot 12. tednu zdravljenja, se mora zdravljenje z vsemi 3 komponentami režima nadaljevati tako, da v celoti traja 24 tednov.
Patients with genotype 3 infection were treated with daclatasvir + sofosbuvir +/- ribavirin for 12 or 24 weeks, where the longer treatment duration was associated with a lower risk for relapse (around 5%) in a preliminary analysis.
Bolniki z okužbo z genotipom 3 so se zdravili z daklatasvirjem + sofosbuvirjem +/- ribavirinom 12 ali 24 tednov, če je preliminarna analiza pokazala, da je daljše trajanje zdravljenja povezano z manjšim tveganjem za ponovitev (približno 5 %).
Use of highly effective contraception should be continued for 5 weeks after completion of Daklinza therapy (see section 4.6).
Z uporabo zelo učinkovite kontracepcije je treba nadaljevati še 5 tednov po zaključku zdravljenja z zdravilom Daklinza (glejte poglavje 4.6).
Treatment-naïve patients with HCV genotype 1 who received 12 weeks of treatment had a similar response as those treated for 24 weeks (Table 6).
Pri predhodno nezdravljenih bolnikih z genotipom 1 HCV, ki so se zdravili 12 tednov, je bil odziv podoben kot pri bolnikih, ki so se zdravili 24 tednov (tabela 6).
Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a cyclophilin inhibitor.
7 bolnikov je prejemalo sofosbuvir + ribavirin, 2 bolnika pa sta prejemala zaviralec ciklofilina.
Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
Podatki, ki podpirajo zdravljenje okužbe z genotipom 2 z zdravilom Daklinza in sofosbuvirjem, so omejeni.
Treatment outcomes in study AI444010 for patients with HCV genotype 4 are presented in Table 13.
Izidi zdravljenja v študiji AI444010 pri bolnikih z genotipom 4 HCV so prikazani v tabeli 13.
Overall, SVR12 was achieved by 97% (149/153) of patients administered daclatasvir and sofosbuvir for 12 weeks in ALLY-2.
V študiji ALLY-2 je bil SVR12 dosežen pri 97 % (149/153) bolnikov, ki so daklatasvir in sofosbuvir prejemali 12 tednov.
If treatment interruption of components in the regimen is necessary because of adverse reactions, Daklinza must not be given as monotherapy.
Če je treba zdravljenje z drugimi zdravili v režimu zdravljenja zaradi pojava neželenih učinkov prekiniti, se zdravila Daklinza ne sme uporabljati v monoterapiji.
Anhydrous lactose Microcrystalline cellulose Croscarmellose sodium Silicon dioxide (E551) Magnesium stearate
Jedro tablete brezvodna laktoza mikrokristalna celuloza premreženi natrijev karmelozat silicijev dioksid (E551) magnezijev stearat
HCV Treatmentnaïve N=101
HCV, brez predhodnega zdravljenja N=101
Emergent daclatasvir resistance-associated substitutions have been shown to persist for 2 years posttreatment and beyond for patients treated with other daclatasvir-based regimens.
Za substitucije, povezane z odpornostjo proti daklatasvirju, ki so se pojavile med zdravljenjem, je bilo dokazano, da so prisotne še 2 leti po zdravljenju in dlje pri bolnikih, zdravljenih z drugimi režimi na osnovi daklatasvirja.
Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2.
Ciroza je bila določena z biopsijo jeter, z metodo FibroScan (> 14,6 kPa) ali z oceno FibroTesta ≥ 0,75 in indeksom razmerja med aspartat-aminotransferazo (AST) in trombociti (APRI) > 2.
Patient demographics and baseline disease characteristics are summarised in Table 10.
Demografske lastnosti bolnikov in izhodiščne značilnosti bolezni so povzete v tabeli 10.
The majority of genotype 1a failures had emergent NS5A variants detected at Q30 (127/139 [91%]), and the majority of genotype 1b failures had emergent NS5A variants detected at L31 (37/49 [76%]) and/or Y93H (34/49 [69%]).
Večina neodziva pri genotipu 1a je bila povezana s pojavom variant NS5A, odkritih pri Q30 (127/139 [91 %]), večina neodziva pri genotipu 1b pa s pojavom variant NS5A, odkritih pri L31 (37/49 [76 %]) in/ali Y93H (34/49 [69 %]).
Moderate inducers of CYP3A4
Zmerni induktorji CYP3A4
These substitutions conferred low level resistance (EC50 <1 nM) for genotype 1b, and higher levels of resistance for genotype 1a (EC50 up to 350 nM).
Te substitucije so bile pri genotipu 1b povezane z odpornostjo nizke stopnje (EC50 < 1 nM), pri genotipu 1a pa z odpornostjo višje stopnje (EC50 do 350 nM).
In healthy subjects, administration of daclatasvir 60 mg tablet after a high-fat meal decreased daclatasvir Cmax and AUC by 28% and 23%, respectively, compared with administration under fasting conditions.
Pri zdravih osebah sta se pri uporabi daklatasvirja v obliki 60-mg tablete po obroku z visoko vsebnostjo maščob vrednosti Cmax in AUC daklatasvirja zmanjšali, in sicer Cmax za 28 %, AUC pa za 23 %, v primerjavi z uporabo na tešče.
In study AI444040, 211 adults with HCV genotype 1, 2, or 3 infection and without cirrhosis received daclatasvir and sofosbuvir, with or without ribavirin.
V študiji AI444040 je 211 odraslih bolnikov brez ciroze, okuženih z genotipi 1, 2 ali 3 HCV, prejemalo daklatasvir in sofosbuvir, z ribavirinom ali brez njega.
AI444010: Patients received daclatasvir 60 mg once daily (n=158) or placebo (n=78) plus pegIFN/RBV through Week 12.
AI444010: Bolniki so prejemali daklatasvir v odmerku 60 mg enkrat na dan (n=158) ali placebo (n=78) in pegIFN/RBV do 12. tedna.
Posology The recommended dose of Daklinza is 60 mg once daily, to be taken orally with or without meals.
Priporočeni odmerek zdravila Daklinza je 60 mg enkrat na dan, ki ga je treba vzeti peroralno skupaj s hrano ali brez nje.
Lower rates of SVR were observed for patients with cirrhosis (see section 5.1).
Pri bolnikih s cirozo so poročali o nižjih deležih SVR (glejte poglavje 5.1).
Table 1: Recommended treatment for Daklinza interferon-free combination therapy
Tabela 1: Priporočeno kombinirano zdravljenje z zdravilom Daklinza brez interferona
Mothers should be instructed not to breastfeed if they are taking Daklinza.
Materam je treba naročiti, da med zdravljenjem z zdravilom Daklinza ne smejo dojiti.
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 kot sestavo viriona.
Use of highly effective contraception should be continued for 5 weeks after completion of Daklinza therapy (see section 4.5).
Z uporabo zelo učinkovite kontracepcije je treba nadaljevati še 5 tednov po zaključku zdravljenja z zdravilom Daklinza (glejte poglavje 4.5).
The overall cure rate for genotype-3 infected patients who were treated for 12 weeks with sofosbuvir + daclatasvir (without ribavirin) in the presence and absence of the Y93H RAV was 7/13 (54%) and 134/145 (92%), respectively.
Celokupen delež ozdravitev pri bolnikih z okužbo z genotipom 3, ki so se zdravili 12 tednov s sofosbuvirjem + daklatasvirjem (brez ribavirina), je v prisotnosti RAV Y93H znašal 54 % (7/13), v njeni odsotnosti pa 92 % (134/145).
AI444043: 301 treatment-naïve patients with HCV genotype 1 infection and HIV co-infection (10% with compensated cirrhosis) were treated with daclatasvir in combination with pegIFN/RBV.
AI444043: 301 predhodno nezdravljen bolnik z okužbo z genotipom 1 HCV in sočasno okužbo z virusom HIV (10 % s kompenzirano cirozo) se je zdravil z daklatasvirjem v kombinaciji s pegIFN/RBV.
Refer to section 4.3 for a listing of medicinal products that are contraindicated for use with Daklinza due to potential loss of therapeutic effect.
Za seznam zdravil, ki so kontraindicirana za sočasno uporabo z zdravilom Daklinza zaradi možne izgube terapevtskega učinka, glejte poglavje 4.3.
The impact of baseline NS5A RAVs on cure rates of genotype 4 infection is not apparent.
Vpliv RAV NS5A v izhodišču na delež ozdravitve pri okužbi z genotipom 4 ni opažen.
Following multiple oral doses of daclatasvir 60 mg once daily in combination with peginterferon alfa and ribavirin in treatment-naïve patients with genotype 1 chronic HCV, the geometric mean (CV%) daclatasvir Cmax was 1534 (58) ng/ml, AUC0-24h was 14122 (70) ng•h/ml, and Cmin was 232 (83) ng/ml.
Pri ponavljajočih se peroralnih odmerkih daklatasvirja v odmerku 60 mg enkrat na dan v kombinaciji s peginterferonom alfa in ribavirinom pri predhodno nezdravljenih bolnikih s kronično okužbo z genotipom 1 HCV so bile geometrijske srednje (KV %) vrednosti daklatasvirja naslednje: vrednost Cmax 1.534 (58) ng/ml, vrednost AUC0-24h 14.122 (70) ng•h/ml, vrednosti Cmin pa 232 (83) ng/ml.
HCV RNA undetectable SVR12*
HCV RNA nezaznavna SVR12*
The pharmacokinetics of daclatasvir following a single 30 mg oral dose were studied in non-HCV infected subjects with mild (Child-Pugh A), moderate (Child-Pugh B), and severe (Child-Pugh C) hepatic impairment compared with unimpaired subjects.
Farmakokinetiko daklatasvirja po enkratnem 30-mg peroralnem odmerku so preučevali pri bolnikih brez okužbe s HCV z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (Child-Pugh C) okvaro jeter v primerjavi z osebami brez okvare jeter.
Relapse**
Ponovitev**
Daklinza must not be administered as monotherapy.
Zdravilo Daklinza se ne sme uporabljati v monoterapiji.
Cirrhotic cohort N = 60
Kohorta s cirozo N=60
The safety and efficacy of Daklinza in children and adolescents aged below 18 years have not yet been established.
Varnost in učinkovitost zdravila Daklinza pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
Seven percent of patients had compensated cirrhosis; 92% had HCV genotype 1 (72% 1a and 20% 1b) and 8% had HCV genotype 4; 65% of patients had IL-28B rs12979860 non-CC genotypes.
Sedem odstotkov bolnikov je imelo kompenzirano cirozo jeter, 92 % bolnikov je imelo genotip 1 HCV (72 % 1a in 20 % 1b) ter 8 % bolnikov genotip 4 HCV. 65 % bolnikov je imelo ne-CC genotipe IL-28B rs12979860.