natgillin/translations-raw huggingface dataset:
0.180/0.215/0.250 mg once daily for 7/7/7 days (daclatasvir 60 mg once daily)
etinilestradiol 35 μg jedanput na dan tijekom 21 dana + norgestimat 0,180/0,215/0,250 mg jedanput na dan tijekom 7/7/7 dana (daklatazvir 60 mg jedanput na dan)
Population pharmacokinetic analysis of data from clinical studies identified race (categories “other” [patients who are not white, black or Asian] and “black”) as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) and apparent volume of distribution (Vc/F) resulting in slightly higher exposures compared to white patients, but the magnitude of the effect on daclatasvir exposure is not clinically important.
(kategorija „drugi“[bolesnici koje nisu bijele rase, crne rase ili Azijati] i „crna rasa“) predstavlja statistički značajnu kovarijantu za prividni oralni klirens (CL/F) i prividni volumen distribucije (Vc/F)
Expected due to inhibition of OATP 1B1 and/or BCRP by daclatasvir:
OATP 1B1 i/ili BCRP, očekuje se:
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).
Child-Pugh stadija C ustanovljene su u kliničkom ispitivanju ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin tijekom 12 tjedana); međutim, stope SVR-a bile su niže nego u bolesnika s bolešću Child-Pugh stadija A i B.
How to store Daklinza
Kako čuvati lijek Daklinza
INFORMATION IN BRAILLE Daklinza 30 mg
16. PODACI NA BRAILLEOVOM PISMU Daklinza 30 mg
Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes.
Deset posto bolesnika imalo je kompenziranu cirozu, a 75% bolesnika imalo je polimorfizam IL-28B rs12979860 koji nije CC genotipa.
Median age was 55 years (range: 24 to 73); 90% of patients were white; 4% were black/African-American; 5% were Asian; 16% were Hispanic or Latino.
Medijan dobi bio je 55 godina (raspon: 24 do 73); 90% bolesnika su bili bijelci; 4% crnci/Afroamerikanci; 5% Azijati; 16% su bili hispano ili latino porijekla.
ANTIVIRALS, HCV Nucleotide analogue polymerase inhibitor Sofosbuvir 400 mg once daily (daclatasvir 60 mg once daily) Study conducted in patients with chronic HCV infection
ANTIVIROTICI, HCV Nukleotidni analogni inhibitor polimeraze sofosbuvir 400 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
The 211 patients had a median age of 54 years (range: 20 to 70); 83% were white; 12% were black/African-American; 2% were Asian; 20% were Hispanic or Latino.
Tih 211 bolesnika imalo je medijan dobi od 54 godine (raspon: 20 do 70); 83% bolesnika bili su bijelci, 12% crnci/Afroamerikanci, 2% Azijati, a njih 20%
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).
Istodobna primjena sa snažnim induktorima CYP3A4 i P-gp je kontraindicirana, a pri istodobnoj primjeni s umjerenim induktorima ili snažnim inhibitorima CYP3A4 i P-gp preporučuje se prilagoditi dozu lijeka Daklinza (vidjeti Tablicu 4).
↑ Digoxin
↑ digoksin
Table 7: Treatment outcomes, daclatasvir in combination with sofosbuvir for 24 weeks, treatment-naïve patients with HCV genotype 2 or 3 in Study AI444040 Genotype 2
Tablica 7: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom tijekom 24 tjedna, prethodno neliječeni bolesnici s HCV-om genotipa 2 ili 3 u ispitivanju AI444040
↔ Raltegravir
↔ daklatazvir ↔ raltegravir
Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with "BMS" on one side and "215" on the other side.
Svjetlozelena bikonveksna peterokutna tableta dimenzija 9,1 mm x 8,9 mm, s utisnutom oznakom "BMS" na jednoj i "215" na drugoj strani.
Genotype-specific activity
Aktivnost protiv pojedinog genotipa
The dose of Daklinza should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4.
Dozu lijeka Daklinza treba povećati na 90 mg jedanput na dan kada se uzima istodobno s umjerenim induktorima CYP3A4.
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, mexilitine, quinidine or antacids.
inhibitora (npr. enalaprilom), lijekovima iz razreda antagonista receptora angiotenzina II (npr. losartanom, irbesartanom, olmesartanom, kandesartanom, valsartanom), dizopiramidom, propafenonom, flekainidom, meksilitinom, kinidinom ili antacidima.
In study ALLY-2, the combination of daclatasvir and sofosbuvir administered for 12 weeks was evaluated in 153 adults with chronic hepatitis C and HIV co-infection; 101 patients were HCV treatment-naïve and 52 patients had failed prior HCV therapy.
U ispitivanju ALLY-2 ocjenjivalo se 12-tjedno liječenje kombinacijom daklatazvira i sofosbuvira u 153 odrasle osobe s istodobnim kroničnim hepatitisom C i infekcijom HIV-om; 101 bolesnik prethodno nije primao liječenje za HCV, a 52 bolesnika nisu uspješno odgovorila na prethodnu terapiju za HCV.
HCV Treatmentnaïve N=101
Prethodno liječeni za HCV* N=52
↔ Daclatasvir ↔ Enfuvirtide
↔ enfuvirtid
Administration of Daklinza with erythromycin may result in increased concentrations of daclatasvir.
Primjena lijeka Daklinza s eritromicinom može povećati koncentracije daklatazvira.
In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, the total clearance was
U bolesnika koji su nakon peroralne primjene tablete daklatazvira od 60 mg primili intravensku dozu [13C,15N]-daklatazvira od 100 µg, ukupni je klirens iznosio 4,24 l/h.
Daklinza in combination with peginterferon alfa and ribavirin The most frequently reported adverse reactions were fatigue, headache, pruritus, anaemia, influenzalike illness, nausea, insomnia, neutropenia, asthenia, rash, decreased appetite, dry skin, alopecia, pyrexia, myalgia, irritability, cough, diarrhoea, dyspnoea and arthralgia.
Najčešće prijavljene nuspojave bile su umor, glavobolja, pruritus, anemija, bolest nalik gripi, mučnina, nesanica, neutropenija, astenija, osip, smanjen tek, suha koža, alopecija, pireksija, mialgija, razdražljivost, kašalj, proljev, dispneja i artralgija.
Daklinza can be taken with or without a meal.
Daklinza se može uzimati neovisno o obrocima.
Treated patients had a median age of 49 years (range: 20 to 71); 77% of patients were white; 19% were black/African-American; 4% were Hispanic or Latino.
Medijan dobi liječenih bolesnika bio je 49 godina (raspon: 20 do 71); 77% bolesnika bili su bijelci, 19% crnci/Afroamerikanci, a 4% hispanskog ili latinoameričkog podrijetla.
Table 14: Summary of noted newly emergent HCV NS5A substitutions on treatment or during follow-up in treated non-SVR12 subjects infected with HCV genotypes 1 through 3
Tablica 14: Sažetak primijećenih novonastalih supstitucija u proteinu NS5A HCV-a koje su se razvile tijekom liječenja ili tijekom praćenja liječenih ispitanika s infekcijom
INFORMATION IN BRAILLE Daklinza 60 mg
16. PODACI NA BRAILLEOVOM PISMU Daklinza 60 mg
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.
Tijekom liječenja lijekom Daklinza u kombinaciji sa sofosbuvirom prijavljena je omaglica, dok su tijekom liječenja lijekom Daklinza u kombinaciji s peginterferonom alfa i ribavirinom prijavljeni omaglica, poremećaj pažnje, zamagljen vid i smanjena oštrina vida.
Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with "BMS" on one side and "213" on the other side.
Zelena bikonveksna peterokutna tableta dimenzija 7,2 mm x 7,0 mm, s utisnutom oznakom "BMS" na jednoj i "213" na drugoj strani.
Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily)
Inhibitor integraze dolutegravir 50 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, estimated volume of distribution at steady state was 47 l. In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes.
U bolesnika koji su nakon peroralne primjene daklatazvir tablete od 60 mg primili intravensku dozu [13C,15N]-daklatazvira od 100 µg, procijenjeni volumen distribucije u stanju dinamičke ravnoteže iznosio je 47 l.
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.
HCV-om genotipa 1, geometrijska srednja vrijednost (CV%) Cmax daklatazvira iznosila je 1534 (58) ng/ml, AUC0-24h je bio14122 (70) ng•h/ml, a Cmin 232 (83) ng/ml.
Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2
Tablica 11: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom u bolesnika s istodobnom infekcijom HCV-om i HIV-om u ispitivanju ALLY-2
400 mg daily
400 mg na dan
Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3
Tablica 12: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom tijekom 12 tjedana, bolesnici s HCV-om genotipa 3 u ispitivanju ALLY-3
Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC genotypes.
Većina bolesnika (71%, uključujući 98% bolesnika koji nisu odgovorili na prethodno liječenje inhibitorom proteaze) imala je polimorfizam IL-28B rs12979860 koji nije CC genotipa.
Table 2: Ribavirin dosing guidelines for coadministration with Daklinza regimen for patients with cirrhosis or post-transplant
Tablica 2: Smjernice za doziranje ribavirina pri njegovoj istodobnoj primjeni s režimom liječenja lijekom Daklinza u bolesnika s cirozom ili nakon presađivanja Laboratorijska vrijednost/Klinički kriteriji
Patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection were eligible to enroll, including patients with compenstated cirrhosis (ChildPugh A).
4, 5 ili 6, uključujući bolesnike s kompenziranom cirozom (Child-Pugh stadij A).
Some other medicines can interact with Daklinza, affecting the levels of Daklinza in your body.
Neki drugi lijekovi mogu djelovati na lijek Daklinza i tako utjecati na njegove koncentracije u organizmu.
Laboratory Value/Clinical Criteria
Odstupanja laboratorijskih vrijednosti
↔ Daclatasvir AUC: 1.41 (1.32, 1.50) Cmax: 0.77 (0.70, 0.85)
↔ daklatazvir 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 to complete 48 weeks of treatment.
Bolesnici koji su izvorno randomizirani za primanje placeba i oni u skupini liječenoj daklatazvirom koji u 4. tjednu nisu imali HCV RNK < LLOQ, niti nemjerljive razine HCV RNK u 10. tjednu, nastavili su liječenje kombinacijom pegIFN/RBV do ukupno 48 tjedana liječenja.
If you have any questions, ask your doctor or pharmacist.
Ako imate bilo kakvih pitanja, obratite se svom liječniku ili ljekarniku.
Coadministration of Daklinza with rifampicin, rifabutin, rifapentine or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Istodobna primjena lijeka Daklinza s rifampicinom, rifabutinom, rifapentinom ili drugim snažnim induktorima CYP3A4 je kontraindicirana (vidjeti dio 4.3).
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 and 5.2).
umjerenim (Child-Pugh stadij B, vrijednost: 7-9) ili teškim (Child-Pugh stadij C, vrijednost: ≥ 10)
Each 90-mg film-coated tablet contains 173 mg of lactose (as anhydrous).
Jedna filmom obložena tableta od 90 mg sadrži 173 mg laktoze (bezvodne).
Light green biconvex round of dimension 10.16 mm diameter, embossed tablet with "BMS" on one side and "011" on the other side.
Svijetlozelena bikonveksna okrugla tableta promjera 10,16 mm, s otisnutom oznakom "BMS"na jednoj i "011" na drugoj strani.
Coadministration of Daklinza with carbamazepine, oxcarbazepine, phenobarbital, phenytoin or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Istodobna primjena lijeka Daklinza s karbamazepinom, okskarbazepinom, fenobarbitalom, fenitoinom ili drugim snažnim induktorima CYP3A4 je kontraindicirana (vidjeti dio 4.3).
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)