natgillin/translations-raw huggingface dataset:
The relapse rate was around 15%, and similar for patients with Child-Pugh A, B and C. The programmes do not allow for a direct comparison of efficacy between the 12- and 24-week regimens. 
Stopa relapsa je bila oko 15%, i slično u bolesnika s Child-Pugh stadijem A, B i C.
Expected: ↔ Triazolam 
Očekuje se: ↔ daklatazvir
No dose adjustment of Daklinza or rilpivirine is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni rilpivirina.
Emergent daclatasvir resistance-associated substitutions have been shown to persist for 2 years posttreatment and beyond for patients treated with other daclatasvir-based regimens. 
održane tijekom 2 godine nakon liječenja i dulje u bolesnika liječenih drugim režimima utemeljenima na daklatazviru.
No dose adjustment of Daklinza or tenofovir is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni tenofovira.
↑ Norbuprenorphine AUC: 1.62 (1.30, 2.02) Cmax: 1.65 (1.38, 1.99) Cmin: 1.46 (1.12, 1.89) 
↔↑ norbuprenorfin AUC: 1,62 1,30, 2,02) Cmax: 1,65 (1,38; 1,99) Cmin: 1,46 1,12, 1,89)
↔ R-methadone AUC: 1.08 (0.94, 1.24) Cmax: 1.07 (0.97, 1.18) Cmin: 1.08 (0.93, 1.26) 
↔ R-metadon AUC: 1,08 (0,94; 1,24) Cmax: 1,07 (0,97; 1,18) Cmin: 1,08 (0,93; 1,26)
In 9 phase 2/3 studies with daclatasvir in combination with peginterferon alfa + ribavirin or in combination with sofosbuvir +/- ribavirin, the following frequencies of such RAVs were seen at baseline: 7% in genotype 1a infection (M28T, Q30, L31, and/or Y93), 11% in genotype 1b infection (L31 and/or Y93H), 51% in genotype 2 infection (L31M), 8% in genotype 3 infection (Y93H) and 64% in genotype 4 infection (L28 and/or L30). 
(M28T, Q30, L31 i/ili Y93), 11% s infekcijom u genotipom 1b (L31 i/ili Y93H), 51% bolesnika s infekcijom genotipom 2 (L31M), 8% bolesnika s infekcijom genotipom 3 (Y93H) te 64% bolesnika s infekcijom genotipom 4 (L28 i/ili L30).
Daclatasvir inhibits both viral RNA replication and virion assembly. 
Daklatazvir inhibira i replikaciju virusne RNK i sklapanje viriona.
Relapse was defined as HCV RNA ≥LLOQ during follow-up after HCV RNA <LLOQ at end of treatment. 
HCV RNK ≥ LLOQ tijekom praćenja, nakon što je na kraju liječenja HCV RNK bio < LLOQ. Relaps obuhvaća opažanja do kraja 24. tjedna praćenja.
Each 60-mg film-coated tablet contains 116 mg of lactose (as anhydrous). 
Jedna filmom obložena tableta od 60 mg sadrži 116 mg laktoze (bezvodne).
It is not known whether Daklinza passes into human breast milk. 
Nije poznato izlučuje li se Daklinza u majčino mlijeko.
≥ F3 liver fibrosis 
fibroza jetre stupnja ≥ F3
Discontinue ribavirin 
Obustaviti primjenu ribavirina
If you do miss a dose: and you notice within 20 hours of the time you usually take Daklinza, you must take the tablet as soon as possible. 
i primijetite to unutar 20 sati od uobičajenog vremena uzimanja lijeka, dozu morate uzeti što je prije moguće.
Haemoglobin >12 g/dL 
>12 g/dl
No dose adjustment of Daklinza or the NRTI is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni NRTI-ja.
Daklinza + peginterferon alfa + ribavirin 
Daklinza, peginterferonom alfa i ribavirinom
HCV RNA 
HCV GT 3
Ribavirin Dosing Guidelines The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients 
Doza ribavirina, kada se primjenjuje u kombinaciji s lijekom Daklinza, određuje se na temelju tjelesne težine (1000 mg ili 1200 mg u bolesnika teških < 75 kg odnosno ≥75 kg).
Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5). 
Slučajevi teške bradikardije i srčanog bloka uočeni su kada je Daklinza korišten u kombinaciji sa sofosbuvirom i istovremeno s amiodaronom i/ili drugim lijekovima koji snižavaju srčanu frekvenciju
Expected due to CYP3A4 induction by etravirine or nevirapine: 
Budući da etravirin i nevirapin induciraju CYP3A4, očekuje se:
Calcium channel blockers Diltiazem 
Blokatori kalcijevih kanala diltiazem nifedipin amlodipin
Darunavir 800 mg/ritonavir 100 mg once daily (daclatasvir 30 mg once daily) 
↑ daklatazvir darunavir800 mg/ritonavir 100 mg jedanput na dan (daklatazvir 30 mg jedanput na dan)
Expected due to CYP3A4 inhibition by the calcium channel blocker: 
Budući da blokatori kalcijevih kanala inhibiraju CYP3A4, očekuje se:
ACID REDUCING AGENTS H2-receptor antagonists Famotidine 40 mg single dose (daclatasvir 60 mg single dose) 
ANTACIDI Antagonisti H2-receptora famotidin u pojedinačnoj dozi od 40 mg
Daklinza 60 mg: the film-coated tablet is light green, biconvex, pentagonal shape with "BMS" debossed on one side and "215" on the other side. 
Daklinza 60 mg: filmom obložena tableta je svijetlozelena bikonveksna peterokutna tableta s utisnutom oznakom "BMS" na jednoj i "215" na drugoj strani.
Discontinue Daklinza, peginterferon alfa and ribavirin 
Isključiti lijek Daklinza, peginterferon alfa i ribavirin
LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Rosuvastatin 10 mg single dose (daclatasvir 60 mg once daily) 
LIJEKOVI ZA SNIŽAVANJE LIPIDA Inhibitori HMG-KoA reduktaze rosuvastatin u pojedinačnoj dozi od 10 mg (daklatazvir 60 mg jedanput na dan)
Each 30-mg film-coated tablet contains 58 mg of lactose (as anhydrous). 
Jedna filmom obložena tableta od 30 mg sadrži 58 mg laktoze (bezvodne).
Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir. 
Jedna filmom obložena tableta sadrži daklatazvir diklorid u količini koja odgovara 30 mg daklatazvira.
No cirrhosis** 
Bez ciroze**
Benzodiazepines Midazolam 5 mg single dose (daclatasvir 60 mg once daily) 
Benzodiazepini midazolam u pojedinačnoj dozi od 5 mg (daklatazvir 60 mg jedanput na dan)
Excipient(s) with known effect 
Pretvorba rezultata s
Nifedipine 
rilpivirin
Subjects with end-stage renal disease requiring haemodialysis had a 27% increase in daclatasvir AUC and a 20% increase in unbound AUC compared to subjects with normal renal function (see section 4.2). 
AUC daklatazvira i 20% veći AUC nevezanog daklatazvira nego ispitanici s normalnom bubrežnom funkcijom (vidjeti dio 4.2).
Observed emergent NS5A resistance-associated variants are reported in Table 14. 
Primijećene varijante NS5A koje su uzrokovale rezistenciju,
No dose adjustment of Daklinza or enfuvirtide is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni enfuvirtida.
Telaprevir 500 mg q12h (daclatasvir 20 mg once daily) 
telaprevir 500 mg svakih 12 sati (daklatazvir 20 mg jedanput na dan)
↔ Alprazolam 
↔ triazolam
BRISTOL-MYERS SQUIBB S.R.L. 
Bristol-Myers Squibb S.r.l. Loc.
AUC: 0.98 (0.83, 1.15) Cmax: 1.03 (0.84, 1.25) Cmin: 1.06 (0.88, 1.29) 
↔ daklatazvir AUC: 0,98 (0,83, 1,15) Cmax: 1,03 (0,84, 1,25) Cmin: 1,06 (0,88, 1,29)
↔ Daclatasvir ↔ Immunosuppressant 
↔ imunosupresiv
Telaprevir 750 mg q8h (daclatasvir 20 mg once daily) 
telaprevir 750 mg svakih 8 sati (daklatazvir 20 mg jedanput na dan)
600 mg daily 
600 mg na dan
Non-responders (non-SVR12) with baseline and postbaseline sequence with emergent NS5A RAVs M28: T Q30: H, K, R L31: I, M, V P32-deletion H58: D, P S62: L Y93: C, H, N Patient(s) lost to follow-up One patient considered a protocol failure (non-SVR) achieved SVR *** NS5A RAVs monitored at amino acid positions are 28, 29, 30, 31, 32, 58, 62, 92, and 93 
Jedan bolesnik za kojeg se smatralo da nije udovoljavao zahtjevima protokola (bolesnik bez SVR-a) postigao je SVR *** Praćene varijante NS5A koje uzrokuju rezistenciju nalazile su se na aminokiselinskim položajima 28, 29, 30, 31, 32, 58, 62, 92 i 93
Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir. 
Jedna filmom obložena tableta sadrži daklatazvir diklorid u količini koja odgovara 60 mg daklatazvira.
Daklinza 30 mg and 60 mg film-coated tablets 
Daklinza 30 mg i 60 mg filmom obložene tablete 30 mjeseci
No dose adjustment of Daklinza or methadone is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni metadona.
The baseline NS5A RAVs described above had no major impact on cure rates in patients treated with sofosbuvir + daclatasvir +/- ribavirin, with the exception of the Y93H RAV in genotype 3 infection (seen in 16/192 [8%] of patients). 
ribavirinom, uz izuzetak varijante Y93H kod infekcije genotipom 3 (opažene u 16/192 [8%] bolesnika).
Inhibition of OATP 1B1 and BCRP by daclatasvir 
Daklatazvir inhibira OATP1B1 i BCRP.
The dose of Daklinza should be reduced to 30 mg once daily when coadministered with boceprevir or other strong inhibitors of CYP3A4. 
Dozu lijeka Daklinza treba smanjiti na 30 mg jedanput na dan kada se primjenjuje istodobno s boceprevirom ili drugim snažnim inhibitorima CYP3A4.
The AUC associated with this dose in males is 19-fold the clinical AUC exposure. 
AUC nakon primjene navedene doze u mužjaka je 19 puta veći od
Patients with CP C cirrhosis 
Bolesnici s cirozom CP stadija C
Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3). 
Istodobna primjena lijeka Daklinza sa sistemskim deksametazonom ili drugim snažnim induktorima CYP3A4 je kontraindicirana (vidjeti dio 4.3).
Detectable HCV RNA at end of treatment 
Virološki neuspjeh Virološki proboj Mjerljiva HCV RNK na kraju liječenja
Daklinza 90 mg: the film-coated tablet is light green, biconvex, round shape with "BMS" embossed on one side and "011" on the other side 
Daklinza 90 mg filmom obložena tableta je svijetlozelena bikonveksna okrugla tableta s otisnutnom oznakom "BMS" na jednoj i "011" na drugoj strani.
Daklinza 90 mg film-coated tablets 
Daklinza 90 mg filmom obložene tablete
No dose adjustment of Daklinza or warfarin is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni varfarina.
No dose adjustment of either medicinal product is required when Daklinza is coadministered with cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil. 
Kada se Daklinza primjenjuje s ciklosporinom, takrolimusom, sirolimusom ili mikofenolat mofetilom, nije potrebno prilagođavati dozu niti jednog lijeka.
Proton pump inhibitors Omeprazole 40 mg once daily (daclatasvir 60 mg single dose) 
Inhibitori protonske pumpe omeprazol 40 mg jedanput na dan (daklatazvir u pojedinačnoj dozi od 60 mg)
Common (may affect up to 1 in 10 people): decreased appetite difficulty sleeping, irritability dizziness migraine shortness of breath, cough, nasal congestion (blocked nose) hot flush dry skin, unusual hair loss or thinning, rash, itching diarrhoea, vomiting, abdominal pain, constipation, heartburn, excessive gas in the stomach or bowel dry mouth joint pain, aching or tender muscles, not caused by exercise 
navala vrućine suha koža, neuobičajeno opadanje ili stanjivanje kose, osip, svrbež proljev, povraćanje, bol u trbuhu, zatvor, žgaravica, prekomjerna količina plinova u želucu ili crijevima suha usta bol u zglobovima, bol u mišićima ili osjetljivost mišića na dodir koja nije posljedica tjelovježbe
Teл. 
Daklinza.
↔ Daclatasvir AUC: 1.40 (1.29, 1.53) Cmax: 1.04 (0.94, 1.15) Cmin: 1.56 (1.41, 1.71) 
AUC: 1,40 (1,29; 1,53) Cmax: 1,04 (0,94; 1,15) Cmin: 1,56 (1,41; 1,71)
GT: Genotype; CP: Child Pugh * Includes patients co-infected with human immunodeficiency virus (HIV). 
GT: genotip; CP: Child-Pugh
CYP3A4 inhibition by ketoconazole 
Ketokonazol inhibira CYP3A4.
Strong or moderate inducers of CYP3A4 and P-gp may decrease the plasma levels and therapeutic effect of daclatasvir. 
Daklatazvir je supstrat CYP3A4, P-gp i organskog kationskog transportera (OCT) 1. Snažni ili umjereni induktori CYP3A4 i P-gp mogu smanjiti razine daklatazvira u plazmi i njegov terapijski učinak.
Inhibition of P-gp and BCRP by daclatasvir 
Daklatazvir inhibira P-gp i BCRP.
Lopinavir 400 mg/ritonavir 100 mg twice daily (daclatasvir 30 mg once daily) 
Očekuje se: ↔ daklatazvir lopinavir 400mg/ritonavir 100 mg dva puta na dan (daklatazvir 30 mg jedanput na dan)
CYP3A4 inhibition by telaprevir 
Telaprevir inhibira CYP3A4
Daklinza 30 mg film-coated tablets 
Daklinza 30 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir 
NAZIV LIJEKA Daklinza 90 mg tablete daklatazvir
NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir 
NAZIV LIJEKA Daklinza 30 mg tablete daklatazvir
daclatasvir + sofosbuvir N=17 
daklatazvir + sofosbuvir N=17
Rilpivirine 
↔ rilpivirin
Age (years): median (range) Race: White Black/African American Other HCV genotype: 1a 1b 
Rasa: bijela crna/afroamerička druga
End of treatment HCV RNA undetectable SVR12 
HCV RNK nemjerljive razine SVR12
↔ Cyclosporine AUC: 1.03 (0.97, 1.09) Cmax: 0.96 (0.91, 1.02) 
AUC: 1,03 (0,97; 1,09) Cmax: 0,96 (0,91; 1,02)
What Daklinza looks like and contents of the pack Daklinza 30 mg: the film-coated tablet is green, biconvex, pentagonal shape with "BMS" debossed on one side and "213" on the other side. 
Daklinza 30 mg: filmom obložena tableta je zelena bikonveksna peterokutna tableta s utisnutom oznakom "BMS" na jednoj i "213" na drugoj strani.
Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for 
Ciroza je bila određena biopsijom jetre (METAVIR F4) za 14 bolesnika, FibroScan >14,6 kPa za 11 bolesnika ili rezultat FibroTesta ≥0,75 te indeks omjera aspartat aminotransferaza (AST): trombociti (APRI) >2 za 7 bolesnika.
Concerning recommended regimens with different HCV genotypes, see section 4.2. 
Za preporučene režime liječenja s obzirom na različite genotipove HCV-a, vidjeti dio 4.2. Za virološku i kliničku aktivnost protiv pojedinog genotipa, vidjeti dio 5.1.
Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen. 
Za informacije o interakcijama ostalih lijekova u režimu, pročitajte Sažetke opisa svojstava tih lijekova.
daclatasvir + sofosbuvir N=21 
daklatazvir + sofosbuvir N=21
Simeprevir 150 mg once daily (daclatasvir 60 mg once daily) 
Preporuke za istodobnu primjenu simeprevir 150 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
The dose of Daklinza should be reduced to 30 mg once daily when coadministered with cobicistat or other strong inhibitors of CYP3A4. 
Dozu lijeka daklinza potrebno je smanjiti na 30 mg jedanput na dan kada se primjenjuje istodobno s kobicistatom ili drugim snažnim inhibitorima CYP3A4.
Triazolam Alprazolam 
Preporuke za istodobnu primjenu triazolam alprazolam
Table 13: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4 
HCV genotipa 4. Tablica 13: Ishodi liječenja, daklatazvir u kombinaciji s peginterferonom alfa i ribavirinom
NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir 
NAZIV LIJEKA Daklinza 60 mg tablete daklatazvir
Prior telaprevir or boceprevir failures daclatasvir + sofosbuvir N=70 
Bolesnici koji nisu odgovorili na prethodno liječenje telaprevirom ili boceprevirom daklatazvir + sofosbuvir N=70
Ribavirin Dosing Guideline 
Smjernica za doziranje ribavirina
Daklinza 60 mg film-coated tablets 
Daklinza 60 mg filmom obložene tablete
↔ Ribavirin AUC: 0.94 (0.80, 1.11) Cmax: 0.94 (0.79, 1.11) Cmin: 0.98 (0.82, 1.17) 
AUC: 0,94 (0,80; 1,11) Cmax: 0,94 (0,79; 1,11) Cmin: 0,98 (0,82; 1,17)
No dose adjustment of Daklinza is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza.
SVR rates were comparable regardless of HIV regimen, age, race, gender, IL28B allele status, or baseline HCV RNA level. 
Stope SVR-a bile su usporedive neovisno o režimu liječenja HIV-a, dobi, rasi, spolu, statusu alela
↔ Daclatasvir AUC: 1.15 (1.07, 1.24) Cmax: 0.67 (0.61, 0.74) 
AUC: 1,15 (1,07, 1,24) Cmax: 0,67 (0,61, 0,74)
Treatment-naïve 
• ošamućenost
Increase in gastric pH 
Povećanje želučanog pH.
↔ Midazolam AUC: 0.87 (0.83, 0.92) Cmax: 0.95 (0.88, 1.04) 
AUC: 0,87 (0,83; 0,92) Cmax: 0,95 (0,88; 1,04)
daclatasvir + sofosbuvir N=13 
daklatazvir + sofosbuvir N=13
↔ Tacrolimus AUC: 1.00 (0.88, 1.13) Cmax: 1.05 (0.90, 1.23) 
AUC: 1,00 (0,88; 1,13) Cmax: 1,05 (0,90; 1,23)
daclatasvir + sofosbuvir + ribavirin N=56 
daklatazvir + sofosbuvir + ribavirin N=56
Expected due to inhibition of P-gp by daclatasvir: 
Budući da daklatazvir inhibira P-gp,
Skin and subcutaneous tissue disorders common rash, alopecia, pruritus, dry skin Musculoskeletal and connective tissue disorders common arthralgia, myalgia arthralgia, myalgia 
Poremećaji kože i potkožnog tkiva često osip, alopecija, pruritus, suha koža
CYP3A4 inhibition by ritonavir 
Ritonavir inhibira CYP3A4
Coadministration of Daklinza with St. John's wort or other strong inducers of CYP3A4 is contraindicated (see section 4.3). 
Istodobna primjena lijeka Daklinza s gospinom travom ili drugim snažnim induktorima CYP3A4 je kontraindicirana (vidjeti dio 4.3).
Verapamil 
daklatazvir
ANTIFUNGALS Ketoconazole 400 mg once daily (daclatasvir 10 mg single dose) 
ANTIFUNGICI ketokonazol 400 mg jedanput na dan
Common (may affect up to 1 in 10 people): difficulty sleeping dizziness migraine nausea (feeling sick), diarrhoea, abdominal pain joint pain, aching or tender muscles, not caused by exercise 
Često (mogu se javiti u do 1 na 10 osoba): smanjen tek tegobe sa spavanjem, razdražljivost omaglica migrena nedostatak zraka, kašalj, kongestija nosa (začepljen nos)
End of treatment HCV RNA undetectable 
Nemjerljiva razina HCV RNK
Treatment-naïve N=101 
Prethodno liječeni* N=51
daclatasvir + sofosbuvir + ribavirin N=20 
daklatazvir + sofosbuvir + ribavirin N=20
Expected due to CYP3A4 induction by the antimycobacterial: 
Budući da antimikobakterijski lijekovi induciraju CYP3A4, očekuje se:
A third treatment group in study ALLY-2 included 50 HCV treatment-naïve HIV co-infected patients who received daclatasvir and sofosbuvir for 8 weeks. 
HIV-om koji prethodno nisu primali liječenje za HCV i koji su u ovom ispitivanju primali daklatazvir i sofosbuvir tijekom 8 tjedana.
Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222 
Bristol-Myers Squibb spol. s r.o. Tel: +386 1 2355 100
No dose adjustment of Daklinza or escitalopram is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni escitaloprama.
The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza. 
Prije početka liječenja lijekom Daklinza, treba pročitati i Sažetke opisa svojstava drugih lijekova koji se primjenjuju u tom režimu.
IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily) 
ciklosporin u pojedinačnoj dozi od 400 mg (daklatazvir 60 mg jedanput na dan)
Vascular disorders common hot flush 
Krvožilni poremećaji često navala vrućine
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/001 28 tablets (calendar pack) EU/1/14/939/002 28 x 1 tablet 
EU/1/14/939/001 28 tableta (kalendarski označeno pakiranje)
Tablet film-coat 
Tablični prikaz nuspojava
Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily) 
takrolimus u pojedinačnoj dozi od 5 mg (daklatazvir 60 mg jedanput na dan)
*PK parameters for daclatasvir when administered with peginterferon alfa and ribavirin in this study were similar to those observed in a study of HCVinfected subjects administered daclatasvir monotherapy for 14 days. 
*U ovom su ispitivanju farmakokinetički parametri daklatazvira pri istodobnoj primjeni s peginterferonom alfa i ribavirinom bili slični onima primijećenima u ispitivanju
BRISTOL-MYERS SQUIBB, S.A. 
Bristol-Myers Squibb B.V.
daclatasvir + sofosbuvir + ribavirin N=9 
daklatazvir + sofosbuvir + ribavirin N=9
daclatasvir + sofosbuvir + ribavirin N=5 
daklatazvir + sofosbuvir + ribavirin N=5
No dose adjustment of Daklinza or maraviroc is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni maraviroka.
Daclatasvir in combination with peginterferon alfa and ribavirin Baseline NS5A RAVs (at M28T, Q30, L31, and Y93 for genotype 1a; at L31 and Y93 for genotype 1b) increase the risk for non-response in treatment-naive patients infected with genotype 1a and genotype 1b infection. 
Početne varijante NS5A koje su povezane s rezistencijom (M28T, Q30, L31 i Y93 za genotip 1a; L31
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/005 28 tablets (calendar pack) EU/1/14/939/006 28 x 1 tablet 
EU/1/14/939/005 28 tableta (kalendarski označeno pakiranje)
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride). 
Jedna filmom obložena tableta sadrži 30 mg daklatazvira (u obliku daklatazavir diklorida).
Respiratory, thoracic and mediastinal disorders common dyspnoea, dyspnoea exertional, cough, nasal congestion 
Poremećaji dišnog sustava, prsišta i sredoprsja često dispneja, dispneja u naporu, kašalj, kongestija nosa
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride). 
Jedna filmom obložena tableta sadrži 90 mg daklatazvira (u obliku daklatazavir diklorida).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride). 
Jedna filmom obložena tableta sadrži 60 mg daklatazvira (u obliku daklatazvir diklorida).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet 
EU/1/14/939/003 28 tableta (kalendarski označeno pakiranje)
Impact of baseline NS5A RAVs on cure rates 
Utjecaj početnih varijanti proteina NS5A koje su povezane s rezistencijom na stope izlječenja
Dose modification, interruption and discontinuation Dose modification of Daklinza to manage adverse reactions is not recommended. 
Ne preporučuje se prilagođavanje doze lijeka Daklinza radi zbrinjavanja nuspojava.
ND 
U
↑ Dabigatran etexilate 
očekuje se: ↑ dabigatran eteksilat
↓ Daclatasvir 
↔ midazolam
Expected due to CYP3A4 inhibition by the antibacterial: 
Budući da antibakterijski lijekovi inhibiraju CYP3A4, očekuje se: ↑ daklatazvir
P-gp inhibition by daclatasvir 
Daklatazvir inhibira P-gp.
Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil fumarate 300 mg once daily (daclatasvir 60 mg once daily) 
tenofovir dizoproksilfumarat 300 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
Expected due to CYP3A4 inhibition by boceprevir: 
Budući da boceprevir inhibira CYP3A4,
Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 40 (0)21 272 16 00 
Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 111
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. 
Daklinza se primjenjuje tijekom 24 tjedna, u kombinaciji s 24 - 48 tjedana liječenja peginterferonom alfa i ribavirinom:
Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir. 
Jedna filmom obložena tableta sadrži daklatazvir diklorid u količini koja odgovara 90 mg daklatazvira Pomoćne tvari s poznatim učinkom
No dose adjustment of Daklinza or dolutegravir is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni dolutegravira.
Do not take Daklinza if you are allergic to daclatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet) if you are taking (by mouth or other ways that affect the whole body) any of the following medicines - phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures - rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis - dexamethasone, a steroid used to treat allergic and inflammatory diseases - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation). 
ako uzimate (kroz usta ili na drugi način koji utječe na cijelo tijelo) neki od sljedećih lijekova - fenitoin, karbamazepin, okskarbazepin ili fenobarbital, koji se koriste za liječenje epileptičkih napadaja
ANTICONVULSANTS 
ANTIMIKOBAKTERIJSKI
Expected due to CYP3A4 inhibition by atazanavir/cobicistat: ↑ Daclatasvir 
CYP3A4, očekuje se: ↑ daklatazvir flukonazol
Expected due to CYP3A4 inhibition by the antifungal: 
Budući da kobicistat inhibira CYP3A4 očekuje se ↑ daklatazvir
Response was rapid (at Week 4 91% of daclatasvir-treated patients had HCV RNA <LLOQ). 
Ishodi liječenja iz ispitivanja AI444042 prikazani su u Tablici 13. Odgovor je bio brz (u 4. tjednu je 91% bolesnika liječenih daklatazvirom imalo HCV RNK <LLOQ).