FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/001 28 tablets (calendar pack) EU/1/14/939/002 28 x 1 tablet
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/001 28 tablet (koledarsko pakiranje) EU/1/14/939/002 28 x 1 tableta
English: 0.180/0.215/0.250 mg is recommended with Daklinza.
Slovenian: Daklinza priporočamo peroralni kontraceptiv s 35 μg etinilestradiola in 0,180/0,215/0,250 mg norgestimata.
English: If you are unsure of any information in the package leaflets, please contact your doctor or pharmacist.
Slovenian: Če imate o informacijah v teh navodilih kakršno koli vprašanje ali ste kakor koli negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: CYP3A4 inhibition by ritonavir
Slovenian: Zaviranje CYP3A4 z ritonavirjem.
English: No dose adjustment of Daklinza or methadone is required.
Slovenian: Odmerka zdravila Daklinza ali metadona ni treba prilagajati.
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with efavirenz.
Slovenian: Pri sočasni uporabi efavirenza je treba odmerek zdravila Daklinza povečati na 90 mg enkrat na dan.
English: CYP3A4 inhibition by telaprevir
Slovenian: Zaviranje CYP3A4 s telaprevirjem.
English: No data are available on the persistence of daclatasvir resistance-associated substitutions beyond 6 months post-treatment in patients treated with daclatasvir and sofosbuvir with/without ribavirin.
Slovenian: Pri bolnikih, ki so se zdravili z daklatasvirjem in sofosbuvirjem z/brez ribavirina, podatki o trajanju substitucij, povezanih z odpornostjo proti daklatasvirju, več kot 6 mesecev po zdravljenju niso na voljo.
English: Each 30-mg film-coated tablet contains 58 mg of lactose (as anhydrous).
Slovenian: Ena 30-mg filmsko obložena tableta vsebuje 58 mg brezvodne laktoze.
English: Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily)
Slovenian: Zaviralci integraze Dolutegravir 50 mg enkrat na dan (daklatasvir 60 mg enkrat na dan)
English: Expected: ↔ Triazolam
Slovenian: Pričakovano: ↔ Daklatasvir
English: AUC: 0.95 (0.82, 1.10) Cmax: 0.88 (0.78, 0.99) Cmin: 0.91 (0.71, 1.16)
Slovenian: ↔ Daklatasvir* AUC: 0,95 (0,82; 1,10) Cmax: 0,88 (0,78; 0,99) Cmin: 0,91 (0,71; 1,16)
English: 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.
Slovenian: Daklinza 60 mg: svetlo zelena, obojestransko izbočena, peterokotna filmsko obložena tableta z vtisnjeno oznako “BMS” na eni in “215” na drugi strani.
English: 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
Slovenian: Pri enem bolniku SVR ni bil dosežen zaradi neupoštevanja protokola (brez-SVR) Nadzirane RAV NS5A na aminokislinskih pozicijah so 28, 29, 30, 31, 32, 58, 62, 92 in 93.
English: 600 mg daily
Slovenian: 600 mg na dan
English: ↔ Daclatasvir AUC: 1.41 (1.32, 1.50) Cmax: 0.77 (0.70, 0.85)
Slovenian: AUC: 1,41 (1,32; 1,50) Cmax: 0,77 (0,70; 0,85)
English: ≥ F3 liver fibrosis
Slovenian: fibroza jeter ≥ F3 Virusni neodziv
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/003 28 tablet (koledarsko pakiranje) EU/1/14/939/004 28 x 1 tableta
English: No dose adjustment of Daklinza or raltegravir is required.
Slovenian: Odmerka zdravila Daklinza ali raltegravirja ni treba prilagajati.
English: Refer to section 4.5 for established and other potentially significant drug-drug interactions.
Slovenian: Za ugotovljene in druge možne pomembne interakcije med zdravili glejte poglavje 4.5.
English: oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum).
Slovenian: 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).
English: 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.
Slovenian: N]-daklatasvirja, je ocenjeni volumen porazdelitve v stanju dinamičnega ravnovesja znašal 47 l. In vitro študije kažejo, da daklatasvir aktivno in pasivno prehaja v hepatocite.
English: CARDIOVASCULAR AGENTS Antiarrhythmics
Slovenian: ZDRAVILA ZA BOLEZNI SRCA IN OŽILJA Antiaritmiki
English: Telaprevir 750 mg q8h (daclatasvir 20 mg once daily)
Slovenian: Telaprevir 750 mg vsakih 8 ur (daklatasvir 20 mg enkrat na dan)
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir.
Slovenian: Ena filmsko obložena tableta vsebuje daklatasvirjev diklorid v količini, ki ustreza 30 mg daklatasvirja.
English: Daklinza 90 mg film-coated tablets
Slovenian: Daklinza 90 mg filmsko obložene tablete
English: The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza.
Slovenian: Pred uvedbo zdravljenja z zdravilom Daklinza se je treba seznaniti tudi s povzetki glavnih značilnosti drugih zdravil, uporabljenih v režimu kombiniranega zdravljenja.
English: 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
Slovenian: vročinski oblivi suha koža, neobičajno izpadanje ali redčenje las, izpuščaj, srbenje driska, bruhanje, bolečina v trebuhu, zaprtost, zgaga, nabiranje plinov v želodcu ali črevesu suha usta bolečina v sklepih, bolečina ali občutljivost v mišicah, ki nista posledica telesne aktivnosti
English: How to store Daklinza
Slovenian: Shranjevanje zdravila Daklinza
English: Pregnancy
Slovenian: Starostniki
English: Embryo-foetal development
Slovenian: Razvoj zarodkov in plodov
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI
English: 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.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev 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.
English: 11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI)
Slovenian: (> 14,6 kPa), pri 7 bolnikih pa z oceno FibroTesta ≥ 0,75 in indeksom razmerja med aspartataminotransferazo (AST) in trombociti (APRI) > 2.
English: Telaprevir 500 mg q12h (daclatasvir 20 mg once daily)
Slovenian: Telaprevir 500 mg vsakih 12 ur (daklatasvir 20 mg enkrat na dan)
English: No dose adjustment of Daklinza or simeprevir is required.
Slovenian: Odmerka zdravila Daklinza ali simeprevirja ni treba prilagajati.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir
Slovenian: IME ZDRAVILA Daklinza 90 mg tablete daklatasvir
English: No dose adjustment of Daklinza or warfarin is required.
Slovenian: Odmerka zdravila Daklinza ali varfarina ni treba prilagajati.
English: Tell your doctor 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 dabigatran etexilate, used to to prevent blood clots ketoconazole, itraconazole, posaconazole or voriconazole, used to treat fungal infections verapamil, diltiazem, nifedipine or amlodipine, used to decrease blood pressure rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin or pravastatin, used to lower blood cholesterol oral contraceptives
Slovenian: 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.
English: 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.
Slovenian: Pri sočasni uporabi atazanavirja/ritonavirja, atazanavirja/kobicistata ali drugih močnih zaviralcev
English: 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
Slovenian: težave s spanjem omotica migrena navzea (siljenje na bruhanje), driska, bolečina v trebuhu bolečina v sklepih, bolečina ali občutljivost v mišicah, ki nista posledica telesne aktivnosti
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir
Slovenian: IME ZDRAVILA Daklinza 30 mg tablete daklatasvir
English: Daklinza 30 mg film-coated tablets
Slovenian: Daklinza 30 mg filmsko obložene tablete
English: Age (years): median (range) Race: White Black/African American Other HCV genotype: 1a 1b
Slovenian: Starost (leta): mediana (razpon) Rasa: Belci
English: No cirrhosis**
Slovenian: Brez ciroze**
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg daclatasvir (as dihydrochloride) The other ingredients are - 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)
Slovenian: Druge sestavine zdravila so: - Jedro tablete: brezvodna laktoza (glejte poglavje 2), mikrokristalna celuloza, premreženi natrijev karmelozat, silicijev dioksid (E551) in magnezijev stearat.
English: Hepatic impairment
Slovenian: glavobol, utrujenost
English: ↔ Daclatasvir AUC: 1.15 (1.07, 1.24) Cmax: 0.67 (0.61, 0.74)
Slovenian: AUC: 1,15 (1,07; 1,24) Cmax: 0,67 (0,61; 0,74)
English: 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).
Slovenian: nevezanega daklatasvirja pa večja za 20 % kot pri osebah z normalnim delovanjem ledvic (glejte poglavje 4.2).
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
Slovenian: IME ZDRAVILA Daklinza 60 mg tablete daklatasvir
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir.
Slovenian: Ena filmsko obložena tableta vsebuje daklatasvirjev diklorid v količini, ki ustreza 60 mg daklatasvirja.
English: Ribavirin Dosing Guidelines The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients
Slovenian: Pri kombiniranem zdravljenju z zdravilom Daklinza je odmerek ribavirina odvisen od telesne mase (1.000 mg pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg).
English: daclatasvir + sofosbuvir N=17
Slovenian: daklatasvir + sofosbuvir N=17
English: What Daklinza contains The active substance is daclatasvir.
Slovenian: Kaj je zdravilo Daklinza in za kaj ga uporabljamo Zdravilna učinkovina zdravila Daklinza je daklatasvir.
English: See section 4.5.
Slovenian: (glejte poglavji 4.4 in 4.5).
English: ↔ Daclatasvir ↔ Enfuvirtide
Slovenian: Pričakovano: ↔ Daklatasvir ↔ Enfuvirtid
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir.
Slovenian: Ena filmsko obložena tableta vsebuje daklatasvirjev diklorid v količini, ki ustreza 90 mg daklatasvirja.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (PERFORATED) TEXT
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Discontinue Daklinza, peginterferon alfa and ribavirin
Slovenian: Ukinite zdravljenje z zdravilom Daklinza, s peginterferonom alfa in z ribavirinom.
English: No dose adjustment of Daklinza or escitalopram is required.
Slovenian: Odmerka zdravila Daklinza ali escitaloprama ni treba prilagajati.
English: Contraindications of concomitant use (see section 4.3) Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A4 and P-gp, e.g. phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum), and thus may lead to lower exposure and loss of efficacy of Daklinza.
Slovenian: in P-gp, npr. fenitoin, karbamazepin, okskarbazepin, fenobarbital, rifampicin, rifabutin, rifapentin, sistemski deksametazon in zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), saj se pri sočasni uporabi lahko zmanjša izpostavljenost zdravilu Daklinza in izgubi njegova učinkovitost.
English: Expected due to CYP3A4 inhibition by the antibacterial:
Slovenian: Pričakovano zaradi zaviranja CYP3A4 z zdravili za zdravljenje glivičnih okužb:
English: HIV antiviral agents, refer to section 4.5.
Slovenian: Za priporočila za odmerjanje skupaj s protivirusnimi zdravili proti HIV glejte poglavje 4.5.
English: Expected due to CYP3A4 inhibition by the calcium channel blocker:
Slovenian: Pričakovano zaradi zaviranja CYP3A4 z zaviralcem kalcijevih kanalčkov: ↑ Daklatasvir
English: daclatasvir + sofosbuvir N=21
Slovenian: daklatasvir + sofosbuvir N=21
English: Follow guidelines above for haemoglobin
Slovenian: > 50 ml/min upoštevajte zgornje smernice za hemoglobin
English: Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3
Slovenian: Tabela 12: Izidi zdravljenja v študiji ALLY-3, daklatasvir v kombinaciji s sofosbuvirjem 12 tednov, bolniki z genotipom 3 HCV Predhodno nezdravljeni N=101
English: No dose adjustment of Daklinza or maraviroc is required.
Slovenian: Odmerka zdravila Daklinza ali maraviroka ni treba prilagajati.
English: GT: Genotype; CP: Child Pugh * Includes patients co-infected with human immunodeficiency virus (HIV).
Slovenian: GT: genotip; CP: Child-Pugh
English: 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.
Slovenian: 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.
English: Daclatasvir administered as a tablet was readily absorbed following multiple oral doses with peak plasma concentrations occurring between 1 and 2 hours.
Slovenian: Daklatasvir v obliki tablete se pri ponavljajočih se peroralnih odmerkih hitro absorbira.
English: Patients with HCV infection (across genotypes) at high risk of decompensation or death within 12 months if left untreated were treated under compassionate use programmes.
Slovenian: Bolnike z okužbo s HCV (kateri koli genotip) in visokim tveganjem za dekompenzacijo ali smrt v
English: In addition some medicines may affect the way Daklinza works.
Slovenian: Nekatera druga zdravila lahko vplivajo na delovanje zdravila Daklinza in spremenijo količino zdravila
English: Daklinza 60 mg film-coated tablets
Slovenian: Daklinza 60 mg filmsko obložene tablete
English: IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
Slovenian: ZDRAVILA ZA ZAVIRANJE IMUNSKE ODZIVNOSTI Ciklosporin, enkratni 400-mg odmerek (daklatasvir 60 mg enkrat na dan)
English: On-treatment virologic failure
Slovenian: Virusni neodziv med zdravljenjem
English: AUC: 1.01 (0.95, 1.07) Cmax: 1.11 (1.02, 1.20)
Slovenian: ↔ Etinilestradiol AUC: 1,01 (0,95; 1,07) Cmax: 1,11 (1,02; 1,20)
English: Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily)
Slovenian: Takrolimus, enkratni 5-mg odmerek (daklatasvir 60 mg enkrat na dan)
English: Administration of Daklinza with verapamil may result in increased concentrations of daclatasvir.
Slovenian: Daklinza in verapamila se koncentracije daklatasvirja lahko povečajo.
English: daclatasvir + sofosbuvir N=13
Slovenian: daklatasvir + sofosbuvir N=13
English: ↔ Darunavir AUC: 0.90 (0.73, 1.11) Cmax: 0.97 (0.80, 1.17) Cmin: 0.98 (0.67, 1.44)
Slovenian: AUC: 0,90 (0,73; 1,11) Cmax: 0,97 (0,80; 1,17) Cmin: 0,98 (0,67; 1,44)
English: Induction of CYP3A4 by efavirenz
Slovenian: Indukcija CYP3A4 z efavirenzem.
English: HCV Treatmentnaïve
Slovenian: Druga protivirusna zdravila za zdravljenje okužbe s HCV
English: Titanium dioxide (E171) Macrogol 400
Slovenian: - Filmska obloga: hipromeloza, titanov dioksid (E171), makrogol 400, indigotin (E132) in rumeni železov oksid (E172).
English: daclatasvir + sofosbuvir + ribavirin N=56
Slovenian: daklatasvir + sofosbuvir + ribavirin N=56
English: Coadministration with medicinal products that strongly induce cytochrome P450 3A4 (CYP3A4) and P-glycoprotein transporter (P-gp) and thus may lead to lower exposure and loss of efficacy of Daklinza.
Slovenian: Pri sočasni uporabi zdravil, ki so močni induktorji citokroma P450 3A4 (CYP3A4) in prenašalca
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Slovenian: Če imate o predpisanih zdravilih kakršno koli vprašanje, se posvetujte z zdravnikom ali farmacevtom.
English: daclatasvir + sofosbuvir + ribavirin N=20
Slovenian: daklatasvir + sofosbuvir + ribavirin N=20
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Srčne aritmije
English: 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.
Slovenian: Daklinza 30 mg: zelena, obojestransko izbočena, peterokotna filmsko obložena tableta z vtisnjeno oznako “BMS” na eni in “213” na drugi strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 90 mg daklatasvirja (v obliki daklatasvirjevega diklorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 30 mg daklatasvirja (v obliki daklatasvirjevega diklorida).
English: No dose adjustment of either medicinal product is required when Daklinza is coadministered with cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil.
Slovenian: Daklinza in ciklosporina, takrolimusa, sirolimusa ali mofetilmikofenolata odmerka nobenega od zdravil ni treba prilagajati.
English: Expected due to inhibition of OATP 1B1 and/or BCRP by daclatasvir:
Slovenian: OATP 1B1 in/ali BCRP z daklatasvirjem: ↑ koncentracija statina
English: NNRTI-based Other
Slovenian: na osnovi PI na osnovi NNRTI drugo brez
English: This is because Daklinza may affect the way some medicines work.
Slovenian: Zdravilo Daklinza lahko vpliva na delovanje nekaterih drugih zdravil, nekatera druga zdravila pa lahko vplivajo na delovanje zdravila Daklinza.
English: CORTICOSTEROIDS Systemic dexamethasone
Slovenian: KORTIKOSTEROIDI Sistemski deksametazon
English: When Daklinza is used together with sofosbuvir (without ribavirin), the following side effects have been reported.
Slovenian: Pri uporabi zdravila Daklinza skupaj s sofosbuvirjem (brez ribavirina) so poročali o naslednjih neželenih učinkih: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone with or without other drugs that lower heart rate.
Slovenian: Pri uporabi zdravila Daklinza v kombinaciji s sofosbuvirjem in sočasni uporabi amiodarona, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
English: Coadministration of Daklinza with carbamazepine, oxcarbazepine, phenobarbital, phenytoin or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Slovenian: Daklinza s karbamazepinom, z okskarbazepinom, s fenobarbitalom, fenitoinom ali z drugimi močnimi induktorji
English: Virologic breakthrough
Slovenian: Povečanje virusnega bremena med zdravljenjem (“virologic breakthrough”)
English: Dose adjustment of Daklinza is recommended when coadministered with strong inhibitors of CYP3A4 (see Table 4).
Slovenian: Uporaba zdravila Daklinza je kontraindicirana v kombinaciji z zdravili, ki močno inducirajo CYP3A4
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 60 mg daklatasvirja (v obliki daklatasvirjevega diklorida).
English: Sirolimus Mycophenolate mofetil
Slovenian: Sirolimus Mofetilmikofenolat
English: daclatasvir + sofosbuvir + ribavirin N=5
Slovenian: daklatasvir + sofosbuvir + ribavirin N=5
English: daclatasvir + sofosbuvir + ribavirin N=9
Slovenian: daklatasvir + sofosbuvir + ribavirin N=9
English: ANTIVIRALS, HIV or HBV Protease inhibitors (PIs) Atazanavir 300 mg/ritonavir 100 mg once daily (daclatasvir 20 mg once daily)
Slovenian: Atazanavir 300 mg/ritonavir 100 mg enkrat na dan (daklatasvir 20 mg enkrat na dan)
English: Vascular disorders common hot flush
Slovenian: Žilne bolezni pogosti vročinski oblivi
English: Palpitations
Slovenian: ANTIDEPRESIVI
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER (NON-PERFORATED) TEXT
Slovenian: BESEDILO NA KOLEDARSKEM (NEPERFORIRANEM) PRETISNEM OMOTU
English: 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.
Slovenian: V študiji ALLY-2 so proučevali uporabo kombinacije daklatasvirja in sofosbuvirja 12 tednov pri 153 odraslih s sočasno kronično okužbo z virusom hepatitisa C in virusom HIV.
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with ketoconazole or other strong inhibitors of CYP3A4.
Slovenian: Pri sočasni uporabi ketokonazola ali drugih močnih zaviralcev CYP3A4 je treba odmerek zdravila Daklinza zmanjšati na 30 mg enkrat na dan.
English: Fainting
Slovenian: Izločanje
English: Expected due to CYP3A4 inhibition by boceprevir:
Slovenian: Pričakovano zaradi zaviranja CYP3A4 z boceprevirjem: ↑ Daklatasvir
English: Toxicology
Slovenian: ZDRAVILOM
English: 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).
Slovenian: Pri uporabi zdravila Daklinza v kombinaciji s sofosbuvirjem in sočasni uporabi amiodarona in/ali drugih zdravil, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka
English: HCV genotype:
Slovenian: Genotip HCV: 1a
English: Biotransformation
Slovenian: Organski sistem
English: D.
Slovenian: V
English: ≤8.5 g/dL
Slovenian: ≤ 8,5 g/dl ukinite ribavirin
English: Route of administration Immediate Packaging Pack size
Slovenian: Velikost pakiranja