natgillin/translations-raw huggingface dataset:
This medicine works by stopping the hepatitis C virus from multiplying and infecting new cells.
Ovaj lijek djeluje tako da zaustavlja umnažanje virusa hepatitisa C i zaražavanje novih stanica.
Coadministration of Daklinza can alter the concentration of other medicinal products and other medicinal products may alter the concentration of daclatasvir.
Istodobna primjena lijeka Daklinza može izmijeniti koncentracije drugih lijekova, a drugi lijekovi mogu izmijeniti koncentraciju daklatazvira.
All Genotype 2 N=26
svi s genotipom 2 N=26
ANTIBACTERIALS Clarithromycin Telithromycin
LIJEKOVI klaritromicin telitromicin
If treatment interruption of components in the regimen is necessary because of adverse reactions, Daklinza must not be given as monotherapy.
Ako se primjena drugih lijekova u režimu mora privremeno prekinuti zbog nuspojava, Daklinza se ne smije davati u monoterapiji.
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 su supstitucije uzrokovale rezistenciju niskog stupnja (EC50 < 1 nM) kod genotipa 1b te rezistenciju višeg stupnja kod genotipa 1a (EC50 do 350 nM).
Some patients have reported dizziness, difficulty concentrating, and vision problems while taking Daklinza with other medicines for their hepatitis C infection.
Neki su bolesnici prijavili omaglicu, poteškoće s koncentracijom i tegobe s vidom tijekom liječenja lijekom Daklinza u kombinaciji s drugim lijekovima za liječenje infekcije hepatitisom C.
Total N=152
Ukupno N=152
Cirrhosis status was not reported for four patients in the daclatasvir + pegIFN/RBV group.
Status ciroze nije bio prijavljen za četiri bolesnika u skupini koja je primala daklatazvir + pegIFN/RBV.
The SVR rate for patients treated for 8 weeks was lower with this treatment duration as summarized in Table 11.
Stopa SVR-a u bolesnika liječenih tijekom 8 tjedana bila je niža kod ovog trajanja liječenja, što je i sažeto prikazano u
Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Daklinza in combination with sofosbuvir.
Ako se istovremena primjena amiodarona smatra neophodnom, preporučuje se da se bolesnike pažljivo prati prilikom početka uzimanja lijeka Daklinza u kombinaciji sa sofosbuvirom.
In vitro and in vivo studies showed that daclatasvir is a substrate of P-gp.
In vitro i in vivo ispitivanja pokazala su da je daklatazvir supstrat za P-gp.
All N=41
svi N=41
Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete,obratite se svom liječniku.
Antiviral activity in cell culture
Antivirusno djelovanje u staničnoj kulturi
Administration of Daklinza may increase systemic exposure to medicinal products that are substrates of P-gp, OATP 1B1, OCT1 or BCRP, which could increase or prolong their therapeutic effect and adverse reactions.
Primjena lijeka Daklinza može povećati sistemsku izloženost lijekovima koji su supstrati za P-gp, OATP 1B1, OCT1ili BCRP, što može pojačati ili produljiti njihov terapijski učinak i nuspojave.
Strong inhibitors of CYP3A4 may increase the plasma levels of daclatasvir.
Snažni inhibitori CYP3A4 mogu povećati razine daklatazvira u plazmi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TEKST NA KUTIJI
0.180/0.215/0.250 mg is recommended with Daklinza.
0,180/0,215/0,250 mg norgestimata s lijekom Daklinza.
*Comparison for daclatasvir was to a historical reference (data from 3 studies of daclatasvir 60 mg once daily with peginterferon alfa and ribavirin).
*Usporedba za daklatazvir temelji se na podacima iz prethodnih ispitivanja (podaci iz 3 ispitivanja daklatazvira u dozi od 60 mg jedanput na dan u kombinaciji s peginterferonom alfa i ribavirinom).
All N=126
svi N=126
Following multiple-dose administration of daclatasvir in HCV-infected patients, the terminal elimination half-life of daclatasvir ranged from 12 to 15 hours.
Nakon primjene višestrukih doza daklatazvira u bolesnika s infekcijom HCV-om, terminalno poluvrijeme eliminacije daklatazvira kretalo se u rasponu od 12 do 15 sati.
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Daklinza in combination with sofosbuvir.
Zbog dugog poluvijeka amiodarona, treba također provesti odgovarajuće nadziranje bolesnika koji su prekinuli uzimanje amiodarona unutar nekoliko posljednjih mjeseci, a započet će terapiju lijekom
The most resistant variants with single amino acid substitution in genotype 2a and genotype 3a were F28S (EC50 >300 nM) and Y93H (EC50 >1,000 nM), respectively.
Najrezistentnije varijante sa samo jednom aminokiselinskom zamjenom u genotipu 2a odnosno genotipu 3a bile su F28S (EC50 > 300 nM) odnosno Y93H (EC50 >1000 nM).
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 four open-label studies (AI444040, ALLY-1, ALLY-2 and ALLY-3).
Djelotvornost i sigurnost daklatazvira u dozi od 60 mg jedanput na dan u kombinaciji sa sofosbuvirom u dozi od 400 mg jedanput na dan u liječenju bolesnika s kroničnom infekcijom HCV-om bile su ocijenjene u četiri otvorena ispitivanja (AI444040, ALLY-1, ALLY-2 i ALLY-3).
Caution should be used when Daklinza is coadministered with rosuvastatin or other substrates of OATP 1B1 or BCRP.
Potreban je oprez kada se Daklinza primjenjuje istodobno s rosuvastatinom ili drugim supstratima za OATP 1B1 ili BCRP.
For detailed recommendations regarding pregnancy and contraception, refer to the Summary of Product Characteristics for ribavirin and peginterferon alfa.
Za detaljne preporuke o trudnoći i kontracepciji, pročitajte Sažetke opisa svojstava lijeka za ribavirin i peginterferon alfa.
<75 kg or ≥75 kg, respectively).
(prijelomna vrijednost: 75 kg).
L31V and Y93H were frequently observed resistance substitutions in genotype 1b, while M28T, L31V/M, Q30E/H/R, and Y93C/H/N were frequently observed resistance substitutions in genotype 1a.
L31V i Y93H bile su često primijećene supstitucije koje uzrokuju rezistenciju genotipa 1b, dok su M28T, L31V/M, Q30E/H/R i Y93C/H/N bile često primijećene supstitucije koje uzrokuju rezistenciju genotipa 1a.
Table 8: Demographics and main disease characteristics in Study ALLY-1 Cirrhotic cohort N = 60
Tablica 8: Demografske značajke bolesnika i glavne značajke bolesti u ispitivanju ALLY-1 Kohorta s cirozom N = 60
Table 4: Interactions and dose recommendations with other medicinal products Medicinal products by therapeutic areas
Tablica 4: Interakcije i preporuke za doziranje kod primjene s drugim lijekovima Lijekovi prema terapijskim područjima
If the starting dose is not well-tolerated, the dose should be reduced as clinically indicated, based on haemoglobin and creatinine clearance measurements (see Table 2).
Ako bolesnik ne podnosi dobro početnu dozu, treba je smanjiti sukladno kliničkoj potrebi, na temelju izmjerenih vrijednosti hemoglobina i klirensa kreatinina (vidjeti
Warnings and precautions Talk to your doctor or pharmacist before taking Daklinza.
Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Daklinza.
For HCV genotype specific activity, see sections 4.4 and 5.1.
Za aktivnost protiv pojedinog HCV genotipa vidjeti dijelove 4.4 i 5.1.
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 patients in all subgroups.
Stope SVR12 bile su više u bolesnika koji su imali CC genotip za IL-28B nego u onih koji nisu imali CC genotip te u bolesnika u kojih je početna razina HCV RNK bila manja od 800 000 IU/ml, ali su u svim podskupinama bile dosljedno više u bolesnika liječenih daklatazvirom nego u onih koji su primali placebo.
Patients who had missing data at follow-up Week 12 were considered responders if their next available HCV RNA value was <LLOQ.
Za bolesnike za koje su nedostajali podaci u 12. tjednu praćenja smatralo se da su odgovorili na liječenje ako im je sljedeća dostupna razina HCV RNK bila <LLOQ.
An oral contraceptive containing ethinylestradiol 35 μg and norgestimate
Preporučuje se primjena oralnog kontraceptiva koji sadrži 35 μg etinilestradiola i
Metabolism and nutrition disorders common decreased appetite
Poremećaji metabolizma i prehrane često smanjen tek
In 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.
U kliničkim ispitivanjima daklatazvira u kombinaciji sa sofosbuvirom ili peginterferonom alfa i ribavirinom, vrijednosti HCV RNK u plazmi mjerene su COBAS TaqMan HCV testom (verzija 2.0), namijenjenim za uporabu sa sustavom High Pure System, uz donju granicu kvantifikacije (engl. lower limit of quantification, LLOQ) od 25 IU/ml.
Daclatasvir is an inhibitor of P-gp, organic anion transporting polypeptide (OATP) 1B1, OCT1 and breast cancer resistance protein (BCRP).
Daklatazvir je inhibitor P-gp-a, organskog anionskog transportnog polipeptida (OATP) 1B1, OCT1 te proteina rezistencije na rak dojke (BCRP).
In the cirrhosis cohort, 4 patients with hepatocellular carcinoma underwent liver transplantation after 1-71 days of treatment; 3 of the 4 patients received 12 weeks of post-liver transplant treatment extension and 1 patient, treated for 23 days before transplantation, did not receive treatment extension.
U kohorti s cirozom, 4 bolesnika s hepatocelularnim karcinomom bila su podvrgnuta presađivanju jetre nakon 1 - 71 dana liječenja; u 3 od ta 4 bolesnika liječenje se nakon presađivanja jetre produljilo za 12 tjedana, dok se u 1 bolesnika, koji je primao liječenje tijekom 23 dana prije presađivanja, liječenje nije produljilo.
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).
Daklinza je indicirana u kombinaciji s drugim lijekovima za liječenje kronične infekcije virusom hepatitisa C (HCV) u odraslih (vidjeti dijelove 4.2, 4.4 i 5.1).
Elimination 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).
Nakon peroralne primjene jednokratne doze 14C-daklatazvira u zdravih ispitanika, 88% ukupne radioaktivnosti otkriveno je u fecesu (53% u neizmijenjenu obliku), a 6,6% izlučeno je kroz mokraću
The duration of your treatment will depend on whether you have previously received treatment for your hepatitis C infection, the condition of your liver, and what other medicines you will take with Daklinza.
Trajanje liječenja ovisit će o tome jeste li prethodno već primili liječenje za infekciju hepatitisom C, o stanju jetre i o lijekovima koje ćete uzimati istodobno s lijekom Daklinza.Možda ćete morati uzimati druge lijekove u različitim vremenskim periodima.
Daclatasvir was excreted into the milk of lactating rats with concentrations 1.7- to 2-fold maternal plasma levels.
Daklatazvir se izlučivao u mlijeko ženki štakora u laktaciji u koncentracijama 1,7 do 2 puta većima od razina lijeka u plazmi majke.
Steady state was achieved after 4 days of once-daily administration.
Stanje dinamičke ravnoteže postignuto je nakon 4 dana primjene jedanput na dan.
There are no clinical data in patients with genotype 5 (see section 5.1).
Nema kliničkih podataka o primjeni u bolesnika s infekcijom genotipom 5 (vidjeti dio 5.1).
Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
Podaci koji podupiru liječenje infekcije genotipom 2 lijekom Daklinza i sofosbuvirom su ograničeni.
Patients demographics and main disease characteristics are summarised in Table 8.
Demografske značajke bolesnika i glavne značajke bolesti sažeto su prikazane u Tablici 8.
Toxicology
Toksikologija
All 44 patients with HCV genotype 2 (n=26) or 3 (n=18) infection were treatment-naïve.
Niti jedan od 44 bolesnika s infekcijom HCV-om genotipa 2 (n=26) ili 3 (n=18) prethodno nije bio liječen.
No human data on the effect of daclatasvir on fertility are available.
Nema dostupnih podataka o utjecaju daklatazvira na plodnost u ljudi.
Protease inhibitors (PIs) Boceprevir
Inhibitori proteaze (PI) boceprevir
Sirolimus Mycophenolate mofetil
sirolimus mikofenolat mofetil
In a study of pre- and postnatal development in rats, there was neither maternal nor developmental toxicity at doses up to 50 mg/kg/day, associated with AUC values 2-fold the clinical AUC exposure.
U ispitivanju prenatalnog i postnatalnog razvoja u štakora, nisu primijećene ni toksičnost za majku ni razvojna toksičnost pri dozama do 50 mg/kg na dan, uz vrijednosti AUC-a 2 puta veće od AUC-a nakon kliničke izloženosti u ljudi.
Daclatasvir was not carcinogenic in mice or in rats at exposures 8-fold or 4-fold, respectively, the clinical AUC exposure.
Daklatazvir nije bio kancerogen u miševa niti u štakora pri izloženosti 8 puta, odnosno 4 puta većoj od kliničke AUC izloženosti.
Carcinogenesis and mutagenesis
Kancerogenost i mutagenost
Resistance in cell culture
Rezistencija u staničnoj kulturi
Use of highly effective contraception should be continued for 5 weeks after completion of Daklinza therapy (see section 4.6).
Vrlo učinkovitu kontracepciju treba nastaviti koristiti još 5 tjedana nakon završetka terapije lijekom Daklinza (vidjeti dio 4.6).
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.
EC50 vrijednosti daklatazvira iznosile su 0,003-1,25 nM protiv replikona genotipova 3a, 4a, 5a i 6a, 0,034-19 nM protiv replikona genotipa 2a te 0,020 nM protiv infektivnog virusnog genotipa 2a (JFH-1).
Daklinza must be administered in combination with other medicinal products for the treatment of chronic HCV infection (see sections 4.1 and 4.2).
Daklinza se mora primjenjivati u kombinaciji s drugim lijekovima za liječenje kronične infekcije HCV-om (vidjeti dijelove 4.1 i 4.2).
SVR12 rates were lower among patients with cirrhosis (see Table 12).
Stope SVR12 bile su niže kod bolesnika s cirozom (vidjeti Tablicu 12).
The recommended dose of Daklinza is 60 mg once a day.
Preporučena doza lijeka Daklinza je 60 mg jedanput na dan.
Itraconazole Posaconazole Voriconazole
itrakonazol posakonazol vorikonazol
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 postiglo je 83% (50/60) bolesnika u kohorti s cirozom, uz značajnu razliku između bolesnika s bolešću Child-Pugh stadija A ili B (92 - 94%) u odnosu na one s bolešću Child-Pugh stadija C, te
Refer to section 4.5 for established and other potentially significant drug-drug interactions.
Vidjeti dio 4.5 za potvrđene i druge moguće interakcije s drugim lijekovima.
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.
Bolesnici s infekcijom genotipom 3, liječeni su kombinacijom daklatazvir + sofosbuvir +/- ribavirin tijekom 12 ili 24 tjedna, pri čemu je dulje liječenje bilo povezano s manjim rizikom od relapsa (oko 5%) u preliminarnim analizama.
Overall, SVR12 was achieved by 97% (149/153) of patients administered daclatasvir and sofosbuvir for 12 weeks in ALLY-2.
Ukupno je SVR12 postiglo 97% (149/153) bolesnika koji su primali daklatazvir + sofosbuvir tijekom 12 tjedana u ispitivanju ALLY-2.
The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient infected with genotype 3.
Supstitucija S282T, koja je povezana s rezistencijom na sofosbuvir, pojavila se u samo 1 bolesnika s infekcijom genotipom 3 koji nije postigao SVR12.
Daclatasvir unbound AUC was estimated to be 18%, 39% and 51% higher for subjects with creatinine clearance (CLcr) values of 60, 30 and 15 ml/min, respectively, relative to subjects with normal renal function.
Procijenjeno je da je AUC nevezanog daklatazvira bio 18%, 39% odnosno 51% veći u ispitanika u kojih je klirens kreatinina (CLcr) bio 60, 30 odnosno 15 ml/min nego u ispitanika s normalnom bubrežnom funkcijom.
Tabulated summary of interactions
Tablični sažetak interakcija
The overall safety profile of daclatasvir is based on data from 2215 patients with chronic HCV infection who received Daklinza once daily either in combination with sofosbuvir with or without ribavirin (n=679, pooled data) or in combination with peginterferon alfa and ribavirin (n=1536, pooled data) from a total of 14 clinical studies.
Ukupan profil sigurnosti daklatazvira temelji se na podacima prikupljenima u 2215 bolesnika s kroničnom infekcijom HCV-om koji su primali lijek Daklinza jedanput na dan u kombinaciji sa sofosbuvirom, uz ribavirin ili bez njega (n=679, objedinjeni podaci) ili u kombinaciji s peginterferonom alfa i ribavirinom (n=1536, objedinjeni podaci) u ukupno 14 kliničkih ispitivanja.
There are no virologic treatment stopping rules that apply to the combination of Daklinza with sofosbuvir.
Nema pravila o prekidu virološkog liječenja koja bi se mogla primijeniti na kombinaciju lijeka Daklinza sa sofosbuvirom.
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.
U populacijskoj farmakokinetičkoj analizi utvrđeno je da spol predstavlja statistički značajnu kovarijantu za prividni klirens daklatazvira (CL/F) nakon peroralne primjene jer je CL/F bio nešto niži u žena, ali opseg tog učinka na izloženost daklatazviru nije klinički značajan.
It is not known whether daclatasvir is excreted in human milk.
Nije poznato izlučuje li se daklatazvir u humano mlijeko.
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).
U stanju dinamičke ravnoteže je vezivanje daklatazvira za proteine u bolesnika s infekcijom HCV-om iznosilo približno 99% te nije ovisilo o dozi u ispitivanom rasponu doza (1 mg do 100 mg).
These medicines lower the effect of Daklinza so your treatment will not work.
Navedeni lijekovi smanjuju učinak lijeka Daklinza pa Vaše liječenje neće biti djelotvorno.
Study conducted in patients with chronic HCV infection
Ispitivanje je provedeno u bolesnika s kroničnom infekcijom HCV-om
In study AI444040, 211 adults with HCV genotype 1, 2, or 3 infection and without cirrhosis received daclatasvir and sofosbuvir, with or without ribavirin.
U ispitivanju AI444040, 211 odraslih osoba s infekcijom HCV-om genotipa 1, 2 ili 3 i bez ciroze je primilo daklatazvir i sofosbuvir, sa ili bez ribavirina.
No dose adjustment of Daklinza is required for patients aged ≥65 years (see section 5.2).
Nije potrebno prilagođavati dozu lijeka Daklinza u bolesnika u dobi od ≥ 65 godina (vidjeti dio 5.2).
↔ Daclatasvir*
↔ daklatazvir*
Lamivudine Zidovudine Emtricitabine Abacavir Didanosine Stavudine
lamivudin zidovudin emtricitabin abakavir didanozin stavudin
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs).
Istovremena primjena amiodarona bila je ograničena tijekom kliničkog razvoja sofosbuvira uz izravno djelujuće antivirotike.
Rifabutin Rifapentine
rifabutin rifapentin
Warfarin
varfarin
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 majku koja je uključivala smrtnost, pobačaje, štetne kliničke znakove, smanjenje tjelesne težine i smanjen unos hrane, primijećena je u obje vrste životinja, pri izloženosti 25 puta (štakor) i 72 puta (kunić) većoj od AUC-a nakon kliničke izloženosti u ljudi.
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).
Povećanja vrijednosti ukupnog bilirubina 3./4. stupnja primijećena su u 5% bolesnika (sva u bolesnika s istodobnom infekcijom HIV-om koji su istodobno primali i atazanavir, bolesnika s cirozom Child-Pugh stadija A, B ili C te bolesnika kojima je presađena jetra).
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-a s ekspresijom supstitucija koje uzrokuju rezistenciju na daklatazvir i dalje su bili potpuno osjetljivi na interferon alfa i druge lijekove protiv HCV-a s drugačijim mehanizmima djelovanja, poput (nukleozidnih i nenukleozidnih) inhibitora NS3 proteaze i NS5B polimeraze.
daclatasvir + pegIFN/RBV
daklatazvir + pegIFN/RBV
SVR12 was achieved in 90% of treatment-naïve patients and 86% of treatment-experienced patients.
SVR12 je postignut kod 90% prethodno neliječenih bolesnika te kod 86% onih koji su već bili liječeni.
Among the 167 patients with HCV genotype 1 infection, 126 were treatment-naïve and 41 had failed prior therapy with a PI regimen (boceprevir or telaprevir).
Od 167 bolesnika s infekcijom HCV-om genotipa 1, njih 126 prethodno nije bilo liječeno, a 41 bolesnik nije odgovorio na prethodno liječenje režimom koji je uključivao inhibitor proteaze (boceprevir ili telaprevir).
Use of highly effective contraception should be continued for 5 weeks after completion of Daklinza therapy (see section 4.5).
Vrlo učinkovitu kontracepciju treba nastaviti koristiti još 5 tjedana nakon završetka terapije lijekom Daklinza (vidjeti dio 4.5).
- If undetectable HCV RNA is achieved, but not at both treatment weeks 4 and 12, Daklinza should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.
- ako se postigne nemjerljiva razina HCV RNK, ali ne i u 4. i u 12. tjednu, primjenu lijeka Daklinza treba prekinuti nakon 24 tjedna, a primjenu peginterferona alfa i ribavirina nastaviti tijekom ukupno 48 tjedana.
Modest increases in concentrations of daclatasvir are expected, but no dose adjustment of Daklinza or fluconazole is required.
Očekuju se skromna povećanja koncentracija daklatazvira, ali nije potrebno prilagođavati dozu lijeka Daklinza ni flukonazola.
HCV/HIV co-infection (ALLY-2)
Istodobna infekcija HCV-om i HIV-om (ALLY-2)
Since Daklinza must always be used in combination with other medicines against hepatitis C infection, please make sure that you read the "Do not take" section of the package leaflets for these medicines.
Budući da se Daklinza uvijek mora uzimati u kombinaciji s drugim lijekovima protiv infekcije hepatitisom C, obavezno pročitajte dio "Nemojte uzimati" u Uputama o tim lijekovima.
Nervous system disorders very common headache headache common dizziness, migraine dizziness, migraine
Poremećaji živčanog sustava vrlo često glavobolja glavobolja često omaglica, migrena omaglica, migrena
Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see section 5.1) Recurrent HCV infection post-liver transplant (GT 1, 3 or 4) Patients without cirrhosis
Daklinza + sofosbuvir +/- ribavirin tijekom 24 tjedna (vidjeti dio 5.1) Povrat infekcije HCV-om nakon presađivanja jetre (GT 1, 3 ili 4) Bolesnici bez ciroze