natgillin/translations-raw huggingface dataset:
Among treatment-naïve patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance between SVR12 and SVR24 was 99.5% independent of 
Pri predhodno nezdravljenih bolnikih z ovrednoteno vrednostjo HCV-RNA pri obeh kontrolnih obiskih, to je v 12. in 24. tednu, je bila ugotovljena 99,5-% skladnost med SVR12 in SVR24, neodvisno od trajanja zdravljenja.
- Tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, silicon dioxide (E551) and magnesium stearate - Film-coating: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake (E132), yellow iron oxide (E172) 
- Filmska obloga: hipromeloza, titanov dioksid (E171), makrogol 400, indigotin (E132) in
How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it. 
Zdravilo Daklinza morate jemati tako dolgo, kot vam je to predpisal zdravnik.
Coadministration with strong inducers of CYP3A4 and P-gp is contraindicated while dose adjustment of Daklinza is recommended when coadministered with moderate inducers of CYP3A4 and P-gp (see Table 4). 
Sočasna uporaba z močnimi induktorji CYP3A4 in P-gp je kontraindicirana, pri sočasni uporabi zmernih induktorjev CYP3A4 in P-gp pa je odmerek zdravila Daklinza priporočljivo prilagoditi (glejte tabelo 4).
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment. 
Pri sladkornih bolnikih se lahko po začetku zdravljenja okužbe s HCV z neposredno delujočim protivirusnim zdravilom izboljša nadzor nad sladkorjem, kar ima lahko za posledico simptomatsko hipoglikemijo.
Table 4: Interactions and dose recommendations with other medicinal products 
Tabela 4: Interakcije in priporočila za odmerjanje pri sočasni uporabi drugih zdravil Priporočila pri sočasni uporabi
* Mainly interferon-based therapy +/-NS3/4 PI. ** 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.
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
Daklinza contains less than 1 mmol sodium (23 mg) per maximum dose of 90 mg, that is to say 
Bolniki na dieti z nadzorovanim vnosom natrija Zdravilo Daklinza vsebuje manj kot 1 mmol (23 mg) natrija na največji odmerek 90 mg, kar v bistvu
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Daklinza. 
Po začetku jemanja zdravila Daklinza morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
Respiratory, thoracic and mediastinal disorders dyspnoea, dyspnoea exertional, cough, nasal diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain 
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, dispneja pri telesnem naporu, kašelj, kongestija nosne sluznice driska, bruhanje, bolečina gastroezofagealna refluksna bolezen, zaprtost, suha usta,
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), talk to 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev (npr. laktoze), se pred začetkom jemanja zdravila Daklinza posvetujte s svojim zdravnikom.
Administration of Daklinza with any of these calcium channel blockers may result in increased concentrations of daclatasvir. 
Pri sočasni uporabi zdravila Daklinza in katerega koli zaviralca kalcijevih kanalčkov se koncentracije daklatasvirja lahko povečajo.
Table 14: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4 
Tabela 14: Izidi zdravljenja, daklatasvir v kombinaciji s peginterferonom alfa in ribavirinom (pegIFN/RBV), predhodno nezdravljeni bolniki z genotipom 4 HCV
These active substances include but are not limited to phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum). 
Med te zdravilne učinkovine med drugim spadajo fenitoin, karbamazepin, okskarbazepin, fenobarbital, rifampicin, rifabutin, rifapentin, sistemski deksametazon in zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum).
* 2 patients had detectable HCV RNA at end of treatment; 1 of these patients achieved SVR. 
* 2 bolnika sta ob koncu zdravljenja imela zaznavno raven HCV RNA.
Table 2: Ribavirin dosing guidelines for coadministration with Daklinza regimen for patients with cirrhosis or post-transplant 
Tabela 2: Smernice za odmerjanje ribavirina pri sočasni uporabi z zdravilom Daklinza pri bolnikih s cirozo ali po presaditvi jeter
AI444043 was an open-label, single-arm study of daclatasvir with pegIFN/RBV in treatment-naïve adults with chronic HCV genotype 1 infection who were co-infected 
Študija AI444043 je bila odprta, enoskupinska študija uporabe daklatasvirja v kombinaciji s pegIFN/RBV pri zdravljenju predhodno še nezdravljenih odraslih bolnikov s kronično okužbo z genotipom 1 HCV in sočasno okužbo z virusom HIV.
No dose adjustment of Daklinza is required for patients with mild (Child-Pugh A, score 5-6), moderate (Child-Pugh B, score 7-9) or severe (Child-Pugh C, score ≥10) hepatic impairment (see sections 4.4 
Pri bolnikih z blago (Child-Pugh A, ocena 5-6), zmerno (Child-Pugh B, ocena 7-9) ali s hudo (Child-Pugh C, ocena ≥ 10) okvaro jeter odmerka zdravila Daklinza ni treba prilagajati.
However, if the missed dose is remembered more than 20 hours after the scheduled dose, the dose should be skipped and the next 
Če pa je od predvidenega časa minilo že več kot 20 ur, mora pozabljeni odmerek izpustiti in vzeti le naslednji odmerek ob običajnem času.
Warnings and precautions Talk to your doctor or pharmacist before taking Daklinza. 
Pred začetkom jemanja zdravila Daklinza se posvetujte z zdravnikom ali farmacevtom.
No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see 
Pri bolnikih s katero koli stopnjo okvare ledvic odmerka zdravila Daklinza ni treba prilagajati (glejte
Missed doses 
Okvara ledvic
If treatment interruption of components in the regimen is necessary because of adverse reactions, Daklinza must There are no virologic treatment stopping rules that apply to the combination of Daklinza with 
Če je treba zdravljenje z drugimi zdravili v režimu zdravljenja zaradi pojava neželenih učinkov prekiniti, se zdravila Daklinza ne sme uporabljati v monoterapiji.
Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets daclatasvir 
Daklinza 30 mg filmsko obložene tablete Daklinza 60 mg filmsko obložene tablete
PK trough levels for peginterferon alfa in patients who received peginterferon alfa, ribavirin, and daclatasvir were received peginterferon alfa, ribavirin, 
Pri bolnikih, ki so prejemali peginterferon alfa, ribavirin prejemali peginterferon alfa, ribavirin
No data are available. 
V tabeli niso navedene
Post-LiverTransplant N=53 
Po presaditvi jeter N = 53
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: zelena, obojestransko izbočena, peterokotna filmsko obložena tableta z vtisnjeno oznako “BMS” na eni in “213” na drugi strani.
The table is not all-inclusive. 
Navedba smiselno ni potrebna.
In clinical studies of Daklinza in combination with sofosbuvir with or without ribavirin, 2% of patients had Grade 3 haemoglobin decreases; all of these patients received Daklinza + sofosbuvir + ribavirin. 
V kliničnih študijah zdravila Daklinza v kombinaciji s sofosfubovirjem, z ribavirinom ali brez njega, so pri 2 % bolnikov poročali o zmanjšanju vrednosti hemoglobina stopnje 3.
*PK parameters for daclatasvir when administered with peginterferon alfa and ribavirin in this study were similar to those observed in a study of HCV 
*V tej študiji so bili farmakokinetični parametri za daklatasvir pri uporabi s peginterferonom alfa in ribavirinom študiji pri bolnikih, okuženih s HCV,
The film-coated tablet should not be chewed or crushed due the unpleasant taste of the 
Zaradi neprijetnega okusa zdravilne učinkovine se filmsko obložene tablete ne sme žvečiti ali drobiti.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients (see the Summary of Product Characteristics for ribavirin). 
Posebno skrb je tako treba nameniti preprečitvi nosečnosti pri bolnicah in partnerkah bolnikov (glejte povzetek glavnih značilnosti zdravila za
Follow guidelines above for haemoglobin 200 mg every other day Discontinue ribavirin 
600 mg na dan 400 mg na dan 200 mg na dan ukinite ribavirin upoštevajte zgornje smernice za hemoglobin 200 mg vsak drugi dan ukinite ribavirin
SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies. 
Po režimih kombiniranega protiretrovirusnega zdravljenja (cART - combination antiretroviral therapy), vključno z zdravljenji na osnovi okrepljenega PI, NNRTI in zaviralca integraze
Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with "BMS" on one 
Svetlo zelena, obojestransko izbočena, peterokotna tableta, velikosti 9,1 mm x 8,9 mm, z vtisnjeno oznako “BMS” na eni in “215” na drugi strani.
Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen. 
Za podatke o interakcijah drugih zdravil, uporabljenih v režimu zdravljenja, glejte ustrezne povzetke
12 weeks therapy HCV Treatmentnaïve N=101 
HCV, brez predhodnega zdravljenja N=101
* One treatment-experienced patient achieved SVR12 per local HCV RNA results. 
* Pri enem predhodno že zdravljenem bolniku je bila SVR12 dosežena v skladu z lokalnimi rezultati
One treatment-naïve patient was missing both post-treatment Weeks 12 
Pri enem predhodno nezdravljenem bolniku so manjkali podatki tako v 12. kot 24. tednu po zdravljenju.
↑ Digoxin AUC: 1.27 (1.20, 1.34) 
↔ Daklatasvir AUC: 1,40 (1,29; 1,53)
and you notice within 20 hours of the time you usually take Daklinza, you must take the tablet as soon as possible. 
in od običajnega časa, ko vzamete zdravilo Daklinza, še ni minilo več kot 20 ur, tableto vzemite takoj, ko je to mogoče, nato pa vzemite naslednji odmerek ob običajnem času.
Since Daklinza is used in combination with other agents, the contraindications and warnings for those 
Ker se zdravilo Daklinza uporablja v kombinaciji z drugimi zdravili, je treba upoštevati tudi kontraindikacije in opozorila za uporabo teh zdravil.
Pravastatin 
Predhodno
The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient Emergent daclatasvir resistance-associated substitutions have been shown to persist for 3 years posttreatment and beyond for patients treated with daclatasvir-based regimens. 
Substitucija S282T, povezana z odpornostjo proti sofosbuvirju, se je pojavila le pri 1 bolniku, okuženem z genotipom 3, pri katerem SVR12 ni bil dosežen.
No dose adjustment of midazolam, other benzodiazepines or other CYP3A4 substrates is required when coadministered with Daklinza. 
Pri sočasni uporabi zdravila Daklinza odmerka midazolama, drugih benzodiazepinov ali drugih substratov za CYP3A4 ni treba prilagajati.
Dizziness has been reported during treatment with Daklinza in combination with sofosbuvir, and dizziness, disturbance in attention, blurred vision and reduced visual acuity have been reported during treatment with Daklinza in combination with peginterferon alfa and ribavirin. 
Pri zdravljenju z zdravilom Daklinza v kombinaciji s sofosbuvirjem so poročali o pojavu omotice, pri zdravljenju z zdravilom Daklinza v kombinaciji s sofosbuvirjem in peginterferonom alfa ter ribavirinom pa o omotici, motnjah pozornosti, zamegljenem vidu in zmanjšani ostrini vida.
Daklinza in combination with sofosbuvir 
Zdravilo Daklinza v kombinaciji s sofosbuvirjem
Do not take Daklinza if you are taking 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). 
Ne jemljite zdravila Daklinza, če jemljete katero koli od naslednjih zdravil: fenitoin, karbamazepin, okskarbazepin ali fenobarbital, ki se uporabljajo za zdravljenje rifampicin, rifabutin ali rifapentin, antibiotiki za zdravljenje tuberkuloze.
Other None 
Ελλάδα
If you have any questions about your medicines, please ask your doctor or 
Če imate o predpisanih zdravilih kakršno koli vprašanje, se posvetujte z
Coadministration of Daklinza with rifampicin, rifabutin, rifapentine or other strong inducers of CYP3A4 is contraindicated (see section 4.3). 
Sočasna uporaba zdravila Daklinza z rifampicinom, rifabutinom, rifapentinom ali drugimi močnimi induktorji CYP3A4 je kontraindicirana (glejte poglavje 4.3).
Daclatasvir in combination with sofosbuvir 
Daklatasvir v kombinaciji s sofosbuvirjem
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 
suha koža, neobičajno izpadanje ali redčenje las, izpuščaj, srbenje driska, bruhanje, bolečina v trebuhu, zaprtost, zgaga, nabiranje plinov v želodcu ali črevesu bolečina v sklepih, bolečina ali občutljivost v mišicah, ki nista posledica telesne aktivnosti
Daclatasvir in vitro did not inhibit (IC50 >40 µM) CYP enzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 2D6. 
Daklatasvir in vitro ni zaviral (IC50 > 40 µM) encimov CYP 1A2,
Post-Liver Transplant N = 53 
Po presaditvi jeter N=53
With some of these medicines, your doctor may need to adjust your dose of Daklinza. 
Pri sočasni uporabi nekaterih navedenih zdravil bo zdravnik odmerek zdravila Daklinza morda moral
Table 3: Treatment stopping rules in patients receiving Daklinza in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response 
Tabela 3: Pravila za ukinitev zdravljenja pri bolnikih z nezadostnim virusnim odzivom med zdravljenjem z zdravilom Daklinza v kombinaciji s peginterferonom alfa in z
If you become pregnant, stop taking Daklinza and tell your doctor immediately. 
Če med zdravljenjem z zdravilom Daklinza zanosite, takoj prenehajte jemati zdravilo in o tem nemudoma
*Comparison for daclatasvir was to a studies of daclatasvir 60 mg once daily with peginterferon alfa and ribavirin). 
*Primerjava podatkov za daklatasvir s peginterferonom alfa in ribavirinom).
Expected due to CYP3A4 induction by 
Pričakovano zaradi indukcije CYP3A4
↔ Ethinylestradiol AUC: 1.01 (0.95, 1.07) Cmax: 1.11 (1.02, 1.20) 
↔ Daklatasvir AUC: 1,41 (1,32; 1,50) Cmax: 0,77 (0,70; 0,85)
Patients originally assigned to placebo and those in the daclatasvir group who did not achieve HCV RNA <LLOQ at Week 4 and undetectable at Week 10 continued pegIFN/RBV 
Bolniki, ki so bili prvotno razporejeni v skupino s placebom in bolniki v skupini z daklatasvirjem, ki v 4. tednu niso dosegli vrednost HCV RNA < LLOQ in nezaznavne ravni v 10. tednu, so nadaljevali zdravljenje s pegIFN/RBV celotno 48-tedensko obdobje zdravljenja.
Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with "BMS" on one side 
Zelena, obojestransko izbočena, peterokotna tableta, velikosti 7,2 mm x 7,0 mm, z vtisnjeno oznako “BMS” na eni in “213” na drugi strani.
No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with any of the following: PDE-5 inhibitors, medicinal products in the ACE inhibitor class (e.g. enalapril), medicinal products in the angiotensin II receptor antagonist class (e.g. losartan, irbesartan, olmesartan, candesartan, valsartan), disopyramide, propafenone, flecainide, 
Pri sočasni uporabi daklatasvirja in zaviralcev PDE-5, zdravil iz skupine zaviralcev ACE (npr. enalapril), zdravil iz skupine antagonistov angiotenzina II (npr. losartan, irbesartan, olmesartan, kandesartan, valsartan), dizopiramida, propafenona, flekainida, meksilitina in kinidina ali antacidov ne pričakujemo klinično pomembnih učinkov na farmakokinetiko katerega koli od uporabljenih zdravil.
Coadministration of Daklinza with carbamazepine, oxcarbazepine, phenobarbital, phenytoin or other strong inducers of CYP3A4 is contraindicated (see section 4.3). 
Sočasna uporaba zdravila Daklinza s karbamazepinom, z okskarbazepinom, s fenobarbitalom, fenitoinom ali z drugimi močnimi induktorji CYP3A4 je kontraindicirana (glejte poglavje 4.3).
Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see section 5.1) 
Daklinza + sofosbuvir +/- ribavirin 24 tednov (glejte poglavje 5.1)
Administration of Daklinza with erythromycin may result in increased concentrations of daclatasvir. 
Pri sočasni uporabi zdravila Daklinza in eritromicina se koncentracije daklatasvirja v plazmi lahko povečajo.
The physician in charge of the diabetic care of the patient should be informed when DAA therapy is initiated. 
O začetku zdravljenja z neposredno delujočim protivirusnim zdravilom je treba obvestiti zdravnika, odgovornega za zdravljenje sladkorne bolezni pri
Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily) 
Darunavir 800 mg/ritonavir 100 mg enkrat na dan (daklatasvir 30 mg enkrat na dan)
No dose adjustment of either medicinal product is required when Daklinza is coadministered with cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil. 
Pri sočasni uporabi zdravila Daklinza in ciklosporina, takrolimusa, sirolimusa ali mofetilmikofenolata odmerka nobenega od zdravil ni treba prilagajati.
NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets 
IME ZDRAVILA Daklinza 30 mg filmsko obložene tablete
CP A 
C,
Interactions with medicinal products 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
infection, the condition of your liver, and what other medicines you will take with Daklinza. 
Trajanje zdravljenja je odvisno od predhodnega zdravljenja okužbe z virusom hepatitisa C, stanja jeter in vrste zdravil, ki jih jemljete skupaj z zdravilom Daklinza.
Tell your doctor or pharmacist if you take any of the following medicines: amiodarone or digoxin, used to treat irregular heart beats atazanavir/ritonavir, atazanavir/cobicistat, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate combination tablet, etravirine, nevirapine or efavirenz, used to treat HIV infection boceprevir or telaprevir, used to treat hepatitis C infection clarithromycin, telithromycin or erythromycin, used to treat bacterial infections warfarin and other similar medicines called vitamin K antagonists used to thin the blood. 
atazanavir/ritonavir, atazanavir/kobicistat, elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksil fumarat v obliki kombinirane tablete, etravirin, nevirapin ali efavirenz, ki se uporabljajo za zdravljenje okužbe z virusom HIV.
Administration of daclatasvir 60 mg tablet after a light meal resulted in no reduction in 
Pri uporabi daklatasvirja v obliki 60-mg tablete po lahkem obroku se izpostavljenost daklatasvirju ni spremenila.
The AUC associated with this dose in males is 19-fold the clinical 
Vrednost AUC, povezana s tem odmerkom pri samcih, je bila 19-krat večja od vrednosti AUC pri klinični uporabi.
Table 7: Treatment outcomes, daclatasvir in combination with sofosbuvir for 24 weeks, treatment-naïve patients with HCV genotype 2 or 3 in Study AI444040 
Tabela 7: Izidi zdravljenja v študiji AI444040, daklatasvir v kombinaciji s sofosbuvirjem 24 tednov, predhodno nezdravljeni bolniki z genotipom 2 ali 3 HCV
* Patients who had missing data at follow-up Week 12 were considered responders if their next available ** Cirrhosis status was not reported for four patients in the daclatasvir + pegIFN/RBV group. 
** Pri štirih bolnikih v skupini z daklatasvirjem + pegIFN/RBV o statusu ciroze niso poročali.
Table 9: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks, patients with cirrhosis or HCV recurrence after liver transplantation, 
Tabela 9: Izidi zdravljenja v študiji ALLY-1, daklatasvir v kombinaciji s sofosbuvirjem in ribavirinom 12 tednov, bolniki s cirozo ali ponovitvijo HCV po presaditvi jeter
Safety monitoring is advised when initiating treatment with Daklinza in patients receiving dabigatran etexilate or other intestinal P-gp substrates that have a narrow therapeutic range. 
Pri bolnikih, ki se zdravijo z dabigatran eteksilatom ali drugimi substrati za črevesni P-gp, ki imajo ozki terapevtski indeks, priporočamo skrbno spremljanje po uvedbi zdravljenja z zdravilom Daklinza.
Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride). 
Ena filmsko obložena tableta vsebuje 30 mg ali 60 mg daklatasvirja (v obliki daklatasvirjevega diklorida).
Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3). 
Sočasna uporaba zdravila Daklinza s sistemskim deksametazonom ali z drugimi močnimi induktorji CYP3A4 je kontraindicirana (glejte poglavje 4.3).
Table 9: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks, patients with cirrhosis or HCV recurrence after liver transplantation, Study ALLY-1 
Tabela 9: Izidi zdravljenja v študiji ALLY-1, daklatasvir v kombinaciji s sofosbuvirjem in ribavirinom 12 tednov, bolniki s cirozo ali ponovitvijo HCV po presaditvi jeter Kohorta s cirozo N=60
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Bristol-Myers Squibb S.r.l. 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
The dose of Daklinza should be reduced to 30 mg once daily when coadministered with atazanavir/ritonavir, atazanavir/cobicistat or other strong inhibitors of CYP3A4. 
Pri sočasni uporabi atazanavirja/ritonavirja, atazanavirja/kobicistata ali drugih močnih zaviralcev CYP3A4 je treba odmerek zdravila Daklinza zmanjšati na 30 mg enkrat na dan.
Cross-resistance 
Pojav odpornosti
0.180/0.215/0.250 mg is recommended with Daklinza. 
Za uporabo skupaj z zdravilom Daklinza priporočamo peroralni kontraceptiv s 35 μg etinilestradiola in 0,180/0,215/0,250 mg norgestimata.
Tabulated summary of interactions 
Interakcij s to kombinacijo učinkovin
Table 13: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 24 weeks, HCV genotype 3 patients with cirrhosis in Study ALLY-3C Treatmentexperienced N=24 
Tabela 13: Izidi zdravljenja v študiji ALLY-3C, daklatasvir v kombinaciji s sofosbuvirjem in ribavirinom 24 tednov, bolniki z genotipom 3 HCV s cirozo
Lamivudine Zidovudine Emtricitabine Abacavir 
BESEDILO NA ENOODMERNEM (PERFORIRANEM) PRETISNEM OMOTU
If you can become pregnant, use effective contraception during and for 5 weeks after your treatment 
Ženske v rodni dobi morajo med zdravljenjem in še 5 tednov po zdravljenju z zdravilom Daklinza
Administration of Daklinza with verapamil may result in increased concentrations of daclatasvir. 
Pri sočasni uporabi zdravila Daklinza in verapamila se koncentracije daklatasvirja lahko povečajo.
Daklinza +sofosbuvir + ribavirin N=203 
Neželeni učinki Daklinza +sofosbuvir + ribavirin N=203