natgillin/translations-raw huggingface dataset:
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
AUC: 3.00 (2.62, 3.44) Cmax: 1.57 (1.31, 1.88)
↑ Daklatasvir AUC: 3,00 (2,62; 3,44) Cmax: 1,57 (1,31; 1,88)
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.
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.
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
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
ACID REDUCING AGENTS H2-receptor antagonists Famotidine 40 mg single dose (daclatasvir 60 mg single dose)
Antagonisti histaminskih receptorjev H2 Famotidin, enkratni 40-mg odmerek (daklatasvir, enkratni 60-mg odmerek)
With cirrhosis
S cirozo
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 presaditivi jeter
Administration of Daklinza with erythromycin may result in increased concentrations of daclatasvir.
Daklinza in eritromicina se koncentracije daklatasvirja v plazmi lahko povečajo.
Expected due to CYP3A4 induction by dexamethasone:
Pričakovano zaradi indukcije CYP3A4 z deksametazonom:
No dose adjustment of Daklinza or tenofovir is required.
Odmerka zdravila Daklinza ali tenofovirja ni treba prilagajati.
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.
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.
If you have any questions, ask your doctor or pharmacist.
Če imate kakršno koli vprašanje, se posvetujte z zdravnikom ali farmacevtom.
This regimen is an alternative recommended regimen for patients with genotype 4 infection, without cirrhosis or with compensated cirrhosis.
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.
Benzodiazepines Midazolam 5 mg single dose (daclatasvir 60 mg once daily)
Benzodiazepini Midazolam, enkratni 5-mg odmerek (daklatasvir 60 mg enkrat na dan)
No dose adjustment of Daklinza is required.
Odmerka zdravila Daklinza ni treba prilagajati.
Due to the lack of data, coadministration of Daklinza and etravirine or nevirapine is not recommended.
Daklinza in etravirina ali nevirapina ni priporočljiva.
ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
Rifampicin 600 mg enkrat na dan (daklatasvir, enkratni 60-mg odmerek)
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.
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.
↑ 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)
Daklinza 30 mg and 60 mg film-coated tablets
Daklinza 30 mg in 60 mg filmsko obložene tablete 30 mesecev
↔ Tacrolimus AUC: 1.00 (0.88, 1.13) Cmax: 1.05 (0.90, 1.23)
↔ Takrolimus AUC: 1,00 (0,88; 1,13) Cmax: 1,05 (0,90; 1,23)
AUC: 1.96 (1.84, 2.10) Cmax: 1.50 (1.39, 1.62) Cmin: 2.68 (2.42, 2.98)
↑ Daklatasvir AUC: 1,96 (1,84; 2,10) Cmax: 1,50 (1,39; 1,62) Cmin: 2,68 (2,42; 2,98)
Some patients have reported dizziness, difficulty concentrating, and vision problems while taking Daklinza with other medicines for their hepatitis C infection.
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.
Inhibition of P-gp and BCRP by daclatasvir
Zaviranje P-gp in BCRP z daklatasvirjem.
Ribavirin Dosing Guideline
Smernice za odmerjanje ribavirina
LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Rosuvastatin 10 mg single dose (daclatasvir 60 mg once daily)
ZDRAVILA ZA ZMANJŠANJE RAVNI LIPIDOV Zaviralci reduktaze HMG-CoA Rosuvastatin, enkratni 10-mg odmerek (daklatasvir 60 mg enkrat na dan)
↑ Dolutegravir AUC: 1.33 (1.11, 1.59) Cmax: 1.29 (1.07, 1.57) Cmin: 1.45 (1.25, 1.68)
AUC: 1,33 (1,11; 1,59) Cmax: 1,29 (1,07; 1,57) Cmin: 1,45 (1,25; 1,68)
Nifedipine
Rilpivirin
Respiratory, thoracic and mediastinal disorders common dyspnoea, dyspnoea exertional, cough, nasal congestion
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti dispneja, dispneja pri telesnem naporu, kašelj, kongestija nosne sluznice
No dose adjustment of Daklinza or rilpivirine is required.
Odmerka zdravila Daklinza ali rilpivirina ni treba prilagajati.
Post-LiverTransplant N=53
Po presaditivi jeter N = 53
If you forget to take Daklinza It is important not to miss a dose of this medicine.
Pomembno je, da odmerka tega zdravila ne pozabite vzeti.
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 presaditivi jeter Laboratorijska vrednost/klinični kriterij
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: svetlo zelena, obojestransko izbočena, okrogla filmsko obložena tableta z vtisnjeno oznako “BMS” na eni in “011” na drugi strani.
No dose adjustment of Daklinza or the NRTI is required.
Odmerka zdravila Daklinza ali NRTI-ja ni treba prilagajati.
Frequency of baseline NS5A resistance-associated variants (RAVs) Baseline NS5A RAVs were frequently observed in clinical studies of daclatasvir.
V kliničnih študijah daklatasvirja so v izhodišču pogosto opazili RAV NS5A.
Each 90-mg film-coated tablet contains 173 mg of lactose (as anhydrous).
Ena 90-mg filmsko obložena tableta vsebuje 173 mg brezvodne laktoze.
Laboratory abnormalities
Nenormalni izvidi laboratorijskih preiskav
Light green biconvex round of dimension 10.16 mm diameter, embossed tablet with "BMS" on one side and "011" on the other side.
Svetlo zelena, obojestransko izbočena, okrogla tableta, premera 10,16 mm, z vtisnjeno oznako “BMS” na eni in “011” na drugi strani.
↔ Daclatasvir AUC: 1.40 (1.29, 1.53) Cmax: 1.04 (0.94, 1.15) Cmin: 1.56 (1.41, 1.71)
↔ Daklatasvir AUC: 1,40 (1,29; 1,53) Cmax: 1,04 (0,94; 1,15) Cmin: 1,56 (1,41; 1,71)
Indigo carmine aluminum lake (E132) Yellow iron oxide (E172)
Filmska obloga tablete hipromeloza titanov dioksid (E171) makrogol 400 indigotin (E132) rumeni železov oksid (E172)
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs).
Med kliničnim razvojem sofosbuvirja v kombinaciji z zdravili z direktnim delovanjem na viruse je bila sočasna uporaba amiodarona omejena.
↑ Dabigatran etexilate
↑ Dabigatran eteksilat
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.
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.
Table 6: Treatment outcomes, daclatasvir in combination with sofosbuvir, HCV genotype 1 in Study AI444040
Tabela 6: Izidi zdravljenja v študiji AI444040, daklatasvir v kombinaciji s sofosbuvirjem, genotip 1 HCV
Virologic failure
Virusni neodziv
daclatasvir + pegIFN/RBV N=82
daklatasvir + pegIFN/RBV N=12
Inhibition of OATP 1B1 and BCRP by daclatasvir
Zaviranje OATP 1B1 in BCRP z daklatasvirjem.
Daclatasvir was not carcinogenic in mice or in rats at exposures 8-fold or 4-fold, respectively, the clinical AUC exposure.
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.
Each 60-mg film-coated tablet contains 116 mg of lactose (as anhydrous).
Ena 60-mg filmsko obložena tableta vsebuje 116 mg brezvodne laktoze.
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, obojestransko izbočena, peterokotna tableta, velikosti 7,2 mm x 7,0 mm, z vtisnjeno oznako “BMS” na eni in “213” na drugi strani.
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.
Delež ponovitev je znašal približno 15 % in je bil pri bolnikih z okvaro jeter Child-Pugh A, B ali C podoben.
The recommended dose of Daklinza is 60 mg once a day.
Priporočeni odmerek zdravila Daklinza je 60 mg enkrat na dan. Tableto pogoltnite celo.
Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes.
Deset odstotkov bolnikov je imelo kompenzirano cirozo, 75 % bolnikov pa je imelo ne-CC genotipe IL-28B
Daklinza + sofosbuvir + ribavirin for 12 weeks or
Daklinza + sofosbuvir + ribavirin 12 tednov ali
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.
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.
No dose adjustment of Daklinza or enfuvirtide is required.
Odmerka zdravila Daklinza ali enfuvirtida ni treba prilagajati.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/005 28 tablets (calendar pack) EU/1/14/939/006 28 x 1 tablet
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/005 28 tablet (koledarsko pakiranje) EU/1/14/939/006 28 x 1 tableta
Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2
Tabela 11: Izidi zdravljenja v študiji ALLY-2, daklatasvir v kombinaciji s sofosbuvirjem 12 tednov, bolniki s sočasno okužbo s HCV/HIV
Daclatasvir is a very weak inducer of CYP3A4 and caused a 13% decrease in midazolam exposure.
Daklatasvir je zelo šibek induktor CYP3A4.
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
AUC: 0.82 (0.70, 0.96) Cmax: 0.56 (0.46, 0.67) Cmin: 0.89 (0.75, 1.06)
↔ Daklatasvir AUC: 0,82 (0,70; 0,96) Cmax: 0,56 (0,46; 0,67) Cmin: 0,89 (0,75; 1,06)
↔ Lopinavir* AUC: 1.15 (0.77, 1.72) Cmax: 1.22 (1.06, 1.41) Cmin: 1.54 (0.46, 5.07)
AUC: 1,15 (0,77; 1,72) Cmax: 1,22 (1,06; 1,41) Cmin: 1,54 (0,46; 5,07)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/001 28 tablets (calendar pack) EU/1/14/939/002 28 x 1 tablet
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/001 28 tablet (koledarsko pakiranje) EU/1/14/939/002 28 x 1 tableta
0.180/0.215/0.250 mg is recommended with Daklinza.
Daklinza priporočamo peroralni kontraceptiv s 35 μg etinilestradiola in 0,180/0,215/0,250 mg norgestimata.
If you are unsure of any information in the package leaflets, please contact your doctor or pharmacist.
Če imate o informacijah v teh navodilih kakršno koli vprašanje ali ste kakor koli negotovi, se posvetujte z zdravnikom ali farmacevtom.
CYP3A4 inhibition by ritonavir
Zaviranje CYP3A4 z ritonavirjem.
No dose adjustment of Daklinza or methadone is required.
Odmerka zdravila Daklinza ali metadona ni treba prilagajati.
The dose of Daklinza should be increased to 90 mg once daily when coadministered with efavirenz.
Pri sočasni uporabi efavirenza je treba odmerek zdravila Daklinza povečati na 90 mg enkrat na dan.
CYP3A4 inhibition by telaprevir
Zaviranje CYP3A4 s telaprevirjem.
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.
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.
Each 30-mg film-coated tablet contains 58 mg of lactose (as anhydrous).
Ena 30-mg filmsko obložena tableta vsebuje 58 mg brezvodne laktoze.
Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily)
Zaviralci integraze Dolutegravir 50 mg enkrat na dan (daklatasvir 60 mg enkrat na dan)
Expected: ↔ Triazolam
Pričakovano: ↔ Daklatasvir
AUC: 0.95 (0.82, 1.10) Cmax: 0.88 (0.78, 0.99) Cmin: 0.91 (0.71, 1.16)
↔ Daklatasvir* AUC: 0,95 (0,82; 1,10) Cmax: 0,88 (0,78; 0,99) Cmin: 0,91 (0,71; 1,16)
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: svetlo zelena, obojestransko izbočena, peterokotna filmsko obložena tableta z vtisnjeno oznako “BMS” na eni in “215” na drugi strani.
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
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.
↔ Daclatasvir AUC: 1.41 (1.32, 1.50) Cmax: 0.77 (0.70, 0.85)
AUC: 1,41 (1,32; 1,50) Cmax: 0,77 (0,70; 0,85)
≥ F3 liver fibrosis
fibroza jeter ≥ F3 Virusni neodziv
MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/003 28 tablet (koledarsko pakiranje) EU/1/14/939/004 28 x 1 tableta
No dose adjustment of Daklinza or raltegravir is required.
Odmerka zdravila Daklinza ali raltegravirja ni treba prilagajati.
Refer to section 4.5 for established and other potentially significant drug-drug interactions.
Za ugotovljene in druge možne pomembne interakcije med zdravili glejte poglavje 4.5.
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).
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.
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.
CARDIOVASCULAR AGENTS Antiarrhythmics
ZDRAVILA ZA BOLEZNI SRCA IN OŽILJA Antiaritmiki
Telaprevir 750 mg q8h (daclatasvir 20 mg once daily)
Telaprevir 750 mg vsakih 8 ur (daklatasvir 20 mg enkrat na dan)
Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir.
Ena filmsko obložena tableta vsebuje daklatasvirjev diklorid v količini, ki ustreza 30 mg daklatasvirja.
Daklinza 90 mg film-coated tablets
Daklinza 90 mg filmsko obložene tablete
The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza.
Pred uvedbo zdravljenja z zdravilom Daklinza se je treba seznaniti tudi s povzetki glavnih značilnosti drugih zdravil, uporabljenih v režimu kombiniranega zdravljenja.
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
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
How to store Daklinza
Shranjevanje zdravila Daklinza
Pregnancy
Starostniki
Embryo-foetal development
Razvoj zarodkov in plodov
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI
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.
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.
11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI)
(> 14,6 kPa), pri 7 bolnikih pa z oceno FibroTesta ≥ 0,75 in indeksom razmerja med aspartataminotransferazo (AST) in trombociti (APRI) > 2.
Telaprevir 500 mg q12h (daclatasvir 20 mg once daily)
Telaprevir 500 mg vsakih 12 ur (daklatasvir 20 mg enkrat na dan)
No dose adjustment of Daklinza or simeprevir is required.
Odmerka zdravila Daklinza ali simeprevirja ni treba prilagajati.
NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir
IME ZDRAVILA Daklinza 90 mg tablete daklatasvir
No dose adjustment of Daklinza or warfarin is required.
Odmerka zdravila Daklinza ali varfarina ni treba prilagajati.
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
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.
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
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
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
NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir
IME ZDRAVILA Daklinza 30 mg tablete daklatasvir
Daklinza 30 mg film-coated tablets
Daklinza 30 mg filmsko obložene tablete
Age (years): median (range) Race: White Black/African American Other HCV genotype: 1a 1b
Starost (leta): mediana (razpon) Rasa: Belci
No cirrhosis**
Brez ciroze**
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)
Druge sestavine zdravila so: - Jedro tablete: brezvodna laktoza (glejte poglavje 2), mikrokristalna celuloza, premreženi natrijev karmelozat, silicijev dioksid (E551) in magnezijev stearat.
Hepatic impairment
glavobol, utrujenost
↔ Daclatasvir AUC: 1.15 (1.07, 1.24) Cmax: 0.67 (0.61, 0.74)
AUC: 1,15 (1,07; 1,24) Cmax: 0,67 (0,61; 0,74)
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).
nevezanega daklatasvirja pa večja za 20 % kot pri osebah z normalnim delovanjem ledvic (glejte poglavje 4.2).
NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
IME ZDRAVILA Daklinza 60 mg tablete daklatasvir
Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir.
Ena filmsko obložena tableta vsebuje daklatasvirjev diklorid v količini, ki ustreza 60 mg daklatasvirja.
Ribavirin Dosing Guidelines The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients
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).
daclatasvir + sofosbuvir N=17
daklatasvir + sofosbuvir N=17
What Daklinza contains The active substance is daclatasvir.
Kaj je zdravilo Daklinza in za kaj ga uporabljamo Zdravilna učinkovina zdravila Daklinza je daklatasvir.
See section 4.5.
(glejte poglavji 4.4 in 4.5).
↔ Daclatasvir ↔ Enfuvirtide
Pričakovano: ↔ Daklatasvir ↔ Enfuvirtid
Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir.
Ena filmsko obložena tableta vsebuje daklatasvirjev diklorid v količini, ki ustreza 90 mg daklatasvirja.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (PERFORATED) TEXT
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Discontinue Daklinza, peginterferon alfa and ribavirin
Ukinite zdravljenje z zdravilom Daklinza, s peginterferonom alfa in z ribavirinom.
No dose adjustment of Daklinza or escitalopram is required.
Odmerka zdravila Daklinza ali escitaloprama ni treba prilagajati.