FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Daklinza 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Daklinza 30 mg
English: ↑ Digoxin
Slovenian: ↑ Digoksin
English: Administration of daclatasvir 60 mg tablet after a light meal resulted in no reduction in daclatasvir exposure.
Slovenian: Pri uporabi daklatasvirja v obliki 60-mg tablete po lahkem obroku se izpostavljenost daklatasvirju ni spremenila.
English: 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.
Slovenian: zmanjšanje telesne mase in manjše uživanje hrane, kar so opazili pri obeh vrstah pri izpostavljenosti, ki so bile na osnovi vrednosti AUC 25-krat (podgane) in 72-krat (kunčice) večje od izpostavljenosti pri klinični uporabi.
English: 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.
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri podganah pri odmerkih do 50 mg/kg/dan, kar ustreza vrednostim AUC, ki so 2-krat večje od vrednosti AUC pri klinični uporabi, niso ugotovili niti toksičnih učinkov za mater niti za razvoj.
English: Gastrointestinal disorders very common nausea common diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Slovenian: Bolezni prebavil zelo pogosti navzea pogosti driska, bruhanje, bolečina v trebuhu, gastroezofagealna refluksna bolezen, zaprtost, suha usta, flatulenca navzea, driska, bolečina v trebuhu
English: INFORMATION IN BRAILLE Daklinza 60 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Daklinza 60 mg
English: ↔ Daclatasvir ↔ Rilpivirine
Slovenian: Pričakovano: ↔ Daklatasvir ↔ Rilpivirin
English: Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily)
Slovenian: Digoksin 0,125 mg enkrat na dan (daklatasvir 60 mg enkrat na dan)
English: INFORMATION IN BRAILLE Daklinza 90 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Daklinza 90 mg
English: The film-coated tablet should not be chewed or crushed due the unpleasant taste of the active substance.
Slovenian: Zaradi neprijetnega okusa zdravilne učinkovine se filmsko obložene tablete ne sme žvečiti ali drobiti.
English: ↔ Daclatasvir ↔ Maraviroc
Slovenian: Pričakovano: ↔ Daklatasvir ↔ Maravirok
English: ≤30 mL/min or haemodialysis
Slovenian: ≤ 30 ml/min ali hemodializa ukinite ribavirin
English: 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.
Slovenian: 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.
English: However, as this is a limited effect, dose adjustment of concomitantly administered CYP3A4 substrates is not necessary.
Slovenian: Zaradi tega omejenega učinka pri sočasni uporabi substratov za CYP3A4
English: ANTIVIRALS, HCV Nucleotide analogue polymerase inhibitor Sofosbuvir 400 mg once daily (daclatasvir 60 mg once daily) Study conducted in patients with chronic HCV infection
Slovenian: ZDRAVILA ZA ZDRAVLJENJE VIRUSNIH OKUŽB, HCV Nukleotidni analog zaviralca polimeraze Sofosbuvir 400 mg enkrat na dan (daklatasvir 60 mg enkrat na dan)
English: 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).
Slovenian: 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.
English: The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: Pack size of 28 film-coated tablets in perforated unit dose blisters.
Slovenian: Velikost pakiranja: 28 filmsko obloženih tablet v perforiranih enoodmernih pretisnih omotih.
English: Table 3: Treatment stopping rules in patients receiving Daklinza in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Slovenian: Tabela 3: Pravila za ukinitev zdravljenja pri bolnikih z nezadostnim virusnim odzivom med zdravljenjem z zdravilom Daklinza v kombinaciji s peginterferonom alfa in z ribavirinom
English: No dose adjustment of Daklinza is required for patients aged ≥65 years (see section 5.2).
Slovenian: Pri bolnikih, starih 65 let ali starejših, odmerka zdravila Daklinza ni treba prilagajati (glejte poglavje 5.2).
English: Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen.
Slovenian: Za podatke o interakcijah drugih zdravil, uporabljenih v režimu zdravljenja, glejte ustrezne povzetke glavnih značilnosti zdravila.
English: No dose adjustment of Daklinza or sofosbuvir is required.
Slovenian: Odmerka zdravila Daklinza ali sofosbuvirja ni treba prilagajati.
English: Very common (may affect more than 1 in 10 people): headache, nausea (feeling sick), fatigue reduction in red blood cells (anaemia)
Slovenian: glavobol, navzea (siljenje na bruhanje), utrujenost zmanjšanje števila rdečih krvnih celic (anemija) Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: 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.
Slovenian: Mediana starost zdravljenih bolnikov je bila 49 let (razpon: od 20 do 71 let), 77 % bolnikov je bilo belcev, 19 % bolnikov črncev/Afroameričanov, 4 % bolnikov pa so bili hispanskega ali latinskega porekla.
English: 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).
Slovenian: Posebno skrb je tako treba nameniti preprečitvi nosečnosti pri bolnicah in partnerkah bolnikov (glejte povzetek glavnih značilnosti zdravila za ribavirin).
English: Since Daklinza must always be used with other medicines against hepatitis C infection, please read the package leaflets for these medicines.
Slovenian: Ker je zdravilo Daklinza treba vedno uporabljati skupaj z drugimi zdravili za zdravljenje okužbe z virusom hepatitisa C, preberite ustrezna navodila za uporabo.
English: Daklinza + sofosbuvir + ribavirin for 12 weeks (see section 5.1)
Slovenian: Daklinza + sofosbuvir + ribavirin 12 tednov (glejte poglavje 5.1)
English: AUC: 2.32 (2.06, 2.62) Cmax: 1.46 (1.28, 1.66)
Slovenian: ↑ Daklatasvir AUC: 2,32 (2,06; 2,62) Cmax: 1,46 (1,28; 1,66)
English: ANTIFUNGALS Ketoconazole 400 mg once daily (daclatasvir 10 mg single dose)
Slovenian: Ketokonazol 400 mg enkrat na dan (daklatasvir, enkratni 10-mg odmerek)
English: Darunavir 800 mg/ritonavir 100 mg once daily (daclatasvir 30 mg once daily)
Slovenian: Darunavir 800 mg/ritonavir 100 mg enkrat na dan (daklatasvir 30 mg enkrat na dan)
English: ↔ Cyclosporine AUC: 1.03 (0.97, 1.09) Cmax: 0.96 (0.91, 1.02)
Slovenian: ↔ Ciklosporin AUC: 1,03 (0,97; 1,09) Cmax: 0,96 (0,91; 1,02)
English: HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
Slovenian: ZDRAVILA RASTLINSKEGA IZVORA Šentjanževka (Hypericum perforatum)
English: Simeprevir 150 mg once daily (daclatasvir 60 mg once daily)
Slovenian: Simeprevir 150 mg enkrat na dan (daklatasvir 60 mg enkrat na dan)
English: There are no virologic treatment stopping rules that apply to the combination of Daklinza with sofosbuvir.
Slovenian: Pravila za ukinitev virološkega zdravljenja, ki bi se nanašala na kombinirano zdravljenje z zdravilom Daklinza in sofosbuvirjem, niso na voljo.
English: AUC: 0.21 (0.19, 0.23) Cmax: 0.44 (0.40, 0.48)
Slovenian: ↓ Daklatasvir AUC: 0,21 (0,19; 0,23) Cmax: 0,44 (0,40; 0,48)
English: Close monitoring is recommended if this medicinal product is administered with Daklinza in combination with sofosbuvir (see sections 4.4 and
Slovenian: Kadar se to zdravilo uporablja sočasno z zdravilom Daklinza v kombinaciji s sofosbuvirjem, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
English: In vitro daclatasvir is an inhibitor of renal uptake transporters, OAT1 and 3, and OCT2, but is not expected to have a clinical effect on the pharmacokinetics of substrates of these transporters.
Slovenian: ter OCT2, vendar pa kliničnega učinka na farmakokinetiko substratov za te prenašalce ne pričakujemo.
English: 400 mg daily
Slovenian: 400 mg na dan
English: Steady state was achieved after 4 days of once-daily administration.
Slovenian: Pri uporabi zdravila enkrat na dan je bilo stanje dinamičnega ravnovesja doseženo po 4 dneh.
English: Prior telaprevir or boceprevir failures daclatasvir + sofosbuvir N=70
Slovenian: Predhodno neuspešno zdravljenje s telaprevirjem ali boceprevirjem daklatasvir + sofosbuvir N=70
English: The AUC associated with this dose in males is 19-fold the clinical AUC exposure.
Slovenian: Vrednost AUC, povezana s tem odmerkom pri samcih, je bila 19-krat večja od vrednosti AUC pri klinični uporabi.
English: CYP3A4 induction by rifampicin
Slovenian: Indukcija CYP3A4 z rifampicinom.
English: Expected due to inhibition of P-gp by daclatasvir:
Slovenian: Pričakovano zaradi zaviranja P-gp z daklatasvirjem:
English: 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.
Slovenian: Mediana starost 211 bolnikov je bila 54 let (razpon: od 20 do 70 let), 83 % bolnikov je bilo belcev, 12 % bolnikov črncev/Afroameričanov, 2 % bolnikov Azijcev, 20 % bolnikov pa hispanskega ali latinskega porekla.
English: Treatmentexperienced*
Slovenian: Predhodno že zdravljeni*
English: Lopinavir 400 mg/ritonavir 100 mg twice daily (daclatasvir 30 mg once daily)
Slovenian: Lopinavir 400 mg/ritonavir 100 mg dvakrat na dan (daklatasvir 30 mg enkrat na dan)
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1)
Slovenian: Daklinza + sofosbuvir +/- ribavirin 24 tednov (glejte poglavji 4.4 in 5.1)
English: 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).
Slovenian: Sočasna uporaba z močnimi induktorji CYP3A4 in P-gp je kontraindicirana, pri sočasni uporabi zmernih induktorjev CYP3A4 in P-gp pa je odmerek zdravila
English: AUC: 3.00 (2.62, 3.44) Cmax: 1.57 (1.31, 1.88)
Slovenian: ↑ Daklatasvir AUC: 3,00 (2,62; 3,44) Cmax: 1,57 (1,31; 1,88)
English: 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.
Slovenian: Mediana starost bolnikov je bila 55 let (razpon: od 24 do 73), 90 % bolnikov je bilo belcev, 4 % bolnikov črncev/Afroameričanov, 5 % bolnikov Azijcev, 16 % bolnikov pa je bilo hispanskega ali latinskega porekla.
English: 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
Slovenian: Tabela 7: Izidi zdravljenja v študiji AI444040, daklatasvir v kombinaciji s sofosbuvirjem 24 tednov, predhodno nezdravljeni bolniki z genotipom 2 ali 3 HCV Genotip 2
English: ACID REDUCING AGENTS H2-receptor antagonists Famotidine 40 mg single dose (daclatasvir 60 mg single dose)
Slovenian: Antagonisti histaminskih receptorjev H2 Famotidin, enkratni 40-mg odmerek (daklatasvir, enkratni 60-mg odmerek)
English: With cirrhosis
Slovenian: S cirozo
English: ↔ R-methadone AUC: 1.08 (0.94, 1.24) Cmax: 1.07 (0.97, 1.18) Cmin: 1.08 (0.93, 1.26)
Slovenian: ↔ R-metadon AUC: 1,08 (0,94; 1,24) Cmax: 1,07 (0,97; 1,18) Cmin: 1,08 (0,93; 1,26)
English: 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
Slovenian: Tabela 9: Izidi zdravljenja v študiji ALLY-1, daklatasvir v kombinaciji s sofosbuvirjem in ribavirinom 12 tednov, bolniki s cirozo ali ponovitvijo HCV po presaditivi jeter
English: Administration of Daklinza with erythromycin may result in increased concentrations of daclatasvir.
Slovenian: Daklinza in eritromicina se koncentracije daklatasvirja v plazmi lahko povečajo.
English: Expected due to CYP3A4 induction by dexamethasone:
Slovenian: Pričakovano zaradi indukcije CYP3A4 z deksametazonom:
English: No dose adjustment of Daklinza or tenofovir is required.
Slovenian: Odmerka zdravila Daklinza ali tenofovirja ni treba prilagajati.
English: 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.
Slovenian: 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.
English: If you have any questions, ask your doctor or pharmacist.
Slovenian: Če imate kakršno koli vprašanje, se posvetujte z zdravnikom ali farmacevtom.
English: This regimen is an alternative recommended regimen for patients with genotype 4 infection, without cirrhosis or with compensated cirrhosis.
Slovenian: Zdravilo Daklinza + peginterferon alfa + ribavirin Ta režim je alternativni priporočeni režim zdravljenja pri bolnikih z okužbo z genotipom 4 brez ciroze ali s kompenzirano cirozo.
English: Benzodiazepines Midazolam 5 mg single dose (daclatasvir 60 mg once daily)
Slovenian: Benzodiazepini Midazolam, enkratni 5-mg odmerek (daklatasvir 60 mg enkrat na dan)
English: No dose adjustment of Daklinza is required.
Slovenian: Odmerka zdravila Daklinza ni treba prilagajati.
English: Due to the lack of data, coadministration of Daklinza and etravirine or nevirapine is not recommended.
Slovenian: Daklinza in etravirina ali nevirapina ni priporočljiva.
English: ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
Slovenian: Rifampicin 600 mg enkrat na dan (daklatasvir, enkratni 60-mg odmerek)
English: There was no Y93H RAV present at baseline for genotype-3 infected patients treated for 12-weeks with sofosbuvir + daclatasvir + ribavirin, and thus SVR outcomes cannot be assessed.
Slovenian: Pri bolnikih, okuženih z genotipom 3, ki so se 12 tednov zdravili s sofosbuvirjem + daklatasvirjem + ribavirinom, RAV Y93H v izhodišču ni bila prisotna, zato teh izidov SVR ni mogoče ovrednotiti.
English: ↑ Norbuprenorphine AUC: 1.62 (1.30, 2.02) Cmax: 1.65 (1.38, 1.99) Cmin: 1.46 (1.12, 1.89)
Slovenian: ↑ Norbuprenorfin AUC: 1,62 (1,30; 2,02) Cmax: 1,65 (1,38; 1,99) Cmin: 1,46 (1,12; 1,89)
English: Daklinza 30 mg and 60 mg film-coated tablets
Slovenian: Daklinza 30 mg in 60 mg filmsko obložene tablete 30 mesecev
English: ↔ Tacrolimus AUC: 1.00 (0.88, 1.13) Cmax: 1.05 (0.90, 1.23)
Slovenian: ↔ Takrolimus AUC: 1,00 (0,88; 1,13) Cmax: 1,05 (0,90; 1,23)
English: AUC: 1.96 (1.84, 2.10) Cmax: 1.50 (1.39, 1.62) Cmin: 2.68 (2.42, 2.98)
Slovenian: ↑ Daklatasvir AUC: 1,96 (1,84; 2,10) Cmax: 1,50 (1,39; 1,62) Cmin: 2,68 (2,42; 2,98)
English: Some patients have reported dizziness, difficulty concentrating, and vision problems while taking Daklinza with other medicines for their hepatitis C infection.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri bolniki so pri uporabi zdravila Daklinza skupaj z drugimi zdravili za zdravljenje okužbe z virusom hepatitisa C poročali o pojavu omotice, težavah s koncentracijo in težavah z vidom.
English: Inhibition of P-gp and BCRP by daclatasvir
Slovenian: Zaviranje P-gp in BCRP z daklatasvirjem.
English: Ribavirin Dosing Guideline
Slovenian: Smernice za odmerjanje ribavirina
English: LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Rosuvastatin 10 mg single dose (daclatasvir 60 mg once daily)
Slovenian: ZDRAVILA ZA ZMANJŠANJE RAVNI LIPIDOV Zaviralci reduktaze HMG-CoA Rosuvastatin, enkratni 10-mg odmerek (daklatasvir 60 mg enkrat na dan)
English: ↑ Dolutegravir AUC: 1.33 (1.11, 1.59) Cmax: 1.29 (1.07, 1.57) Cmin: 1.45 (1.25, 1.68)
Slovenian: AUC: 1,33 (1,11; 1,59) Cmax: 1,29 (1,07; 1,57) Cmin: 1,45 (1,25; 1,68)
English: Nifedipine
Slovenian: Rilpivirin
English: Respiratory, thoracic and mediastinal disorders common dyspnoea, dyspnoea exertional, cough, nasal congestion
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja, dispneja pri telesnem naporu, kašelj, kongestija nosne sluznice
English: No dose adjustment of Daklinza or rilpivirine is required.
Slovenian: Odmerka zdravila Daklinza ali rilpivirina ni treba prilagajati.
English: Post-LiverTransplant N=53
Slovenian: Po presaditivi jeter N = 53
English: If you forget to take Daklinza It is important not to miss a dose of this medicine.
Slovenian: Pomembno je, da odmerka tega zdravila ne pozabite vzeti.
English: Table 2: Ribavirin dosing guidelines for coadministration with Daklinza regimen for patients with cirrhosis or post-transplant
Slovenian: Tabela 2: Smernice za odmerjanje ribavirina pri sočasni uporabi z zdravilom Daklinza pri bolnikih s cirozo ali po presaditivi jeter Laboratorijska vrednost/klinični kriterij
English: 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
Slovenian: Daklinza 90 mg: svetlo zelena, obojestransko izbočena, okrogla filmsko obložena tableta z vtisnjeno oznako “BMS” na eni in “011” na drugi strani.
English: No dose adjustment of Daklinza or the NRTI is required.
Slovenian: Odmerka zdravila Daklinza ali NRTI-ja ni treba prilagajati.
English: Frequency of baseline NS5A resistance-associated variants (RAVs) Baseline NS5A RAVs were frequently observed in clinical studies of daclatasvir.
Slovenian: V kliničnih študijah daklatasvirja so v izhodišču pogosto opazili RAV NS5A.
English: Each 90-mg film-coated tablet contains 173 mg of lactose (as anhydrous).
Slovenian: Ena 90-mg filmsko obložena tableta vsebuje 173 mg brezvodne laktoze.
English: Laboratory abnormalities
Slovenian: Nenormalni izvidi laboratorijskih preiskav
English: Light green biconvex round of dimension 10.16 mm diameter, embossed tablet with "BMS" on one side and "011" on the other side.
Slovenian: Svetlo zelena, obojestransko izbočena, okrogla tableta, premera 10,16 mm, z vtisnjeno oznako “BMS” na eni in “011” na drugi strani.
English: ↔ Daclatasvir AUC: 1.40 (1.29, 1.53) Cmax: 1.04 (0.94, 1.15) Cmin: 1.56 (1.41, 1.71)
Slovenian: ↔ Daklatasvir AUC: 1,40 (1,29; 1,53) Cmax: 1,04 (0,94; 1,15) Cmin: 1,56 (1,41; 1,71)
English: Indigo carmine aluminum lake (E132) Yellow iron oxide (E172)
Slovenian: Filmska obloga tablete hipromeloza titanov dioksid (E171) makrogol 400 indigotin (E132) rumeni železov oksid (E172)
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs).
Slovenian: Med kliničnim razvojem sofosbuvirja v kombinaciji z zdravili z direktnim delovanjem na viruse je bila sočasna uporaba amiodarona omejena.
English: ↑ Dabigatran etexilate
Slovenian: ↑ Dabigatran eteksilat
English: Daclatasvir is embryotoxic and teratogenic in rats and rabbits at exposures at or above 4-fold (rat) and 16-fold (rabbit) the clinical AUC exposure.
Slovenian: Pri podganah in kunčicah je daklatasvir pri izpostavljenostih, ki so bile vsaj 4-krat (podgane) in 16-krat (kunčice) večje od vrednosti AUC pri klinični uporabi, deloval embriotoksično in teratogeno.
English: Table 6: Treatment outcomes, daclatasvir in combination with sofosbuvir, HCV genotype 1 in Study AI444040
Slovenian: Tabela 6: Izidi zdravljenja v študiji AI444040, daklatasvir v kombinaciji s sofosbuvirjem, genotip 1 HCV
English: Virologic failure
Slovenian: Virusni neodziv
English: daclatasvir + pegIFN/RBV N=82
Slovenian: daklatasvir + pegIFN/RBV N=12
English: Inhibition of OATP 1B1 and BCRP by daclatasvir
Slovenian: Zaviranje OATP 1B1 in BCRP z daklatasvirjem.
English: Daclatasvir was not carcinogenic in mice or in rats at exposures 8-fold or 4-fold, respectively, the clinical AUC exposure.
Slovenian: Daklatasvir pri miših pri izpostavljenosti, ki je bila na osnovi vrednosti AUC 8-krat večja od izpostavljenosti pri klinični uporabi, ali pri podganah pri izpostavljenosti, ki je bila na osnovi vrednosti AUC 4-krat večja od izpostavljenosti pri klinični uporabi, ni deloval karcinogeno.
English: Each 60-mg film-coated tablet contains 116 mg of lactose (as anhydrous).
Slovenian: Ena 60-mg filmsko obložena tableta vsebuje 116 mg brezvodne laktoze.
English: 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.
Slovenian: Zelena, obojestransko izbočena, peterokotna tableta, velikosti 7,2 mm x 7,0 mm, z vtisnjeno oznako “BMS” na eni in “213” na drugi strani.
English: 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.
Slovenian: Delež ponovitev je znašal približno 15 % in je bil pri bolnikih z okvaro jeter Child-Pugh A, B ali C podoben.
English: The recommended dose of Daklinza is 60 mg once a day.
Slovenian: Priporočeni odmerek zdravila Daklinza je 60 mg enkrat na dan. Tableto pogoltnite celo.
English: Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes.
Slovenian: Deset odstotkov bolnikov je imelo kompenzirano cirozo, 75 % bolnikov pa je imelo ne-CC genotipe IL-28B
English: Daklinza + sofosbuvir + ribavirin for 12 weeks or
Slovenian: Daklinza + sofosbuvir + ribavirin 12 tednov ali
English: Daclatasvir is an inhibitor of HCV genotypes 1a and 1b replication in cell-based replicon assays with effective concentration (50% reduction, EC50) values of 0.003-0.050 and 0.001-0.009 nM, respectively, depending on the assay method.
Slovenian: Vrednost efektivne koncentracije (50-% zmanjšanje, EC50) za genotip 1a znaša 0,003-0,050 nM, za genotip 1b pa 0,001-0,009 nM, odvisno od testne metode.
English: No dose adjustment of Daklinza or enfuvirtide is required.
Slovenian: Odmerka zdravila Daklinza ali enfuvirtida ni treba prilagajati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/005 28 tablets (calendar pack) EU/1/14/939/006 28 x 1 tablet
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/005 28 tablet (koledarsko pakiranje) EU/1/14/939/006 28 x 1 tableta
English: Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2
Slovenian: Tabela 11: Izidi zdravljenja v študiji ALLY-2, daklatasvir v kombinaciji s sofosbuvirjem 12 tednov, bolniki s sočasno okužbo s HCV/HIV
English: Daclatasvir is a very weak inducer of CYP3A4 and caused a 13% decrease in midazolam exposure.
Slovenian: Daklatasvir je zelo šibek induktor CYP3A4.
English: 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.
Slovenian: Pri bolnikih, ki se zdravijo z dabigatran eteksilatom ali drugimi substrati za črevesni
English: AUC: 0.82 (0.70, 0.96) Cmax: 0.56 (0.46, 0.67) Cmin: 0.89 (0.75, 1.06)
Slovenian: ↔ Daklatasvir AUC: 0,82 (0,70; 0,96) Cmax: 0,56 (0,46; 0,67) Cmin: 0,89 (0,75; 1,06)
English: ↔ Lopinavir* AUC: 1.15 (0.77, 1.72) Cmax: 1.22 (1.06, 1.41) Cmin: 1.54 (0.46, 5.07)
Slovenian: AUC: 1,15 (0,77; 1,72) Cmax: 1,22 (1,06; 1,41) Cmin: 1,54 (0,46; 5,07)