FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Icelandic: Sjúklingum sem upphaflega fengu lyfleysu og þeir sem voru í daclatasvir hópnum og höfðu ekki náð HCV RNA < lægri magngreiningarmörk í viku 4 og ógreinanlegt í viku
English: In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes.
Icelandic: In vitro rannsóknir benda til virks og óvirks flutnings daclatasvirs í lifrarfrumur.
English: No dose adjustment of Daklinza or raltegravir is required.
Icelandic: Hvorki þarf að aðlaga skammta Daklinza né raltegravir.
English: Cirrhotic cohort N = 60
Icelandic: Sjúklingar með skorpulifur N= 60
English: ↑ Daclatasvir ↔ Fluconazole
Icelandic: ↔ Fluconazol
English: Simeprevir 150 mg once daily (daclatasvir 60 mg once daily)
Icelandic: Simeprevir 150 mg einu sinni á dag (daclatasvir 60 mg einu sinni á dag)
English: INFORMATION IN BRAILLE Daklinza 90 mg
Icelandic: MEÐ BLINDRALETRI Daklinza 90 mg
English: AUC: 0.95 (0.82, 1.10) Cmax: 0.88 (0.78, 0.99) Cmin: 0.91 (0.71, 1.16)
Icelandic: ↔ Daclatasvir* AUC: 0,95 (0,82; 1,10) Cmax: 0,88 (0,78; 0,99) Cmin: 0,91 (0,71; 1,16)
English: Daklinza 90 mg film-coated tablets
Icelandic: Daklinza 90 mg filmuhúðaðar töflur
English: 200 mg daily
Icelandic: 200 mg daglega
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
Icelandic: Daklinza 90 mg filmuhúðaðar töflur eru ljósgrænar, tvíkúptar kringlóttar töflur með „BMS“ á annarri hliðinni og „011“ á hinni.
English: Laboratory Value/Clinical Criteria
Icelandic: Rannsóknargildi/klínísk viðmið
English: Gastrointestinal disorders very common nausea common diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Icelandic: Meltingarfæri mjög algengar ógleði algengar niðurgangur, uppköst, kviðverkir, vélindabakflæði, hægðatregða, munnþurrkur, uppþemba ógleði, niðurgangur, kviðverkir
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 30 mg daclatasvir (sem tvíhýdróklóríð).
English: BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.
Icelandic: BRISTOL-MYERS SQUIBB POLSKA SP.
English: Expected due to CYP3A4 inhibition by boceprevir:
Icelandic: Áætlað vegna CYP3A4 hömlunar af völdum boceprevirs:
English: Daklinza 30 mg film-coated tablets
Icelandic: Daklinza 30 mg filmuhúðaðar töflur
English: Do not stop taking Daklinza unless your doctor told you to stop.
Icelandic: Daklinza nema samkvæmt fyrirmælum læknisins.
English: Toxicology
Icelandic: Eiturefnafræði
English: AUC: 1.37 (1.24, 1.52) Cmax: 1.30 (1.03, 1.64) Cmin: 1.17 (1.03, 1.32)
Icelandic: ↑ Buprenorphin AUC: 1,37 (1,24; 1,52) Cmax: 1,30 (1,03; 1,64) Cmin: 1,17 (1,03; 1,32)
English: If you become pregnant, stop taking Daklinza and tell your doctor immediately.
Icelandic: Daklinza og láta lækninn tafarlaust vita.
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.
Icelandic: Greint hefur verið frá sundli meðan á samsettri meðferð með Daklinza og sofosbuvir stóð, og sundli, skertri árvekni, þokusýn, minnkaðri sjónskerpu meðan á meðferð með Daklinza í samsettri meðferð með peginterferóni alfa og ribavirini stóð.
English: AUC: 0.84 (0.73, 0.96) Cmax: 0.64 (0.54, 0.77) Cmin: 0.92 (0.80, 1.05)
Icelandic: ↔ Daclatasvir AUC: 0,84 (0,73; 0,96) Cmax: 0,64 (0,54; 0,77) Cmin: 0,92 (0,80; 1,05)
English: D.
Icelandic: T
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Icelandic: Ef spurningar vakna um lyfin skal leita ráða hjá lækninum eða lyfjafræðingi.
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
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum) svefnerfiðleikar  sundl  mígreni ógleði, niðurgangur, kviðverkir liðverkir, vöðvaverkir eða eymsli, ekki tengt hreyfingu
English: Expected due to CYP3A4 inhibition by cobicistat:
Icelandic: Áætlað vegna CYP3A4 hömlunar af völdum cobicistats:
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.
Icelandic: Ekki á að nota Daklinza þegar það er notað í samsettri meðferð með lyfjum sem eru öflugir virkjar sýtókróm P450 3A4 (CYP3A4) og P-glýkóflutningspróteins (P-gp) þar sem það getur dregið úr útsetningu og verkun Daklinza.
English: Dose adjustment of Daklinza is recommended when coadministered with strong inhibitors of CYP3A4 (see Table 4).
Icelandic: Daklinza þegar það er gefið samhliða öflugum CYP3A4 hemlum (sjá töflu 4).
English: CYP3A4 induction by rifampicin
Icelandic: CYP3A4 virkjum fyrir tilstilli rifampicins
English: AUC: 1.10 (1.05, 1.15) Cmax: 0.95 (0.89, 1.02) Cmin: 1.17 (1.10, 1.24)
Icelandic: ↔ Tenofovir AUC: 1,10 (1,05; 1,15) Cmax: 0,95 (0,89; 1,02) Cmin: 1,17 (1,10; 1,24)
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil fumarate 300 mg once daily (daclatasvir 60 mg once daily)
Icelandic: Tenofovir disoproxil fumarat 300 mg einu sinni á dag (daclatasvir 60 mg einu sinni á dag)
English: Telaprevir 750 mg q8h (daclatasvir 20 mg once daily)
Icelandic: Telaprevir 750 mg á 8 klst. fresti (daclatasvir 20 mg einu sinni á dag)
English: Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily)
Icelandic: Tacrolimus 5 mg stakur skammtur (daclatasvir 60 mg einu sinni á dag)
English: Refer to the Summary of Product Characteristics of ribavirin.
Icelandic: Sjá samantekt á eiginleikum ribavirins.
English: There are no virologic treatment stopping rules that apply to the combination of Daklinza with sofosbuvir.
Icelandic: Reglur um stöðvun meðferðar með veiruhemlandi lyfjum sem eiga við um samsetninguna Daklinza ásamt sofobusvir eru ekki fyrir hendi.
English: AUC: 1.12 (1.01, 1.26) Cmax: 1.14 (0.98, 1.32) Cmin: 1.23 (1.09, 1.38)
Icelandic: ↔ Daclatasvir AUC: 1,12 (1,01; 1,26) Cmax: 1,14 (0,98; 1,32) Cmin: 1,23 (1,09; 1,38)
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir.
Icelandic: Hver filmuhúðuð tafla inniheldur daclatasvirtvíhýdróklóríð sem jafngildir 30 mg af daclatasviri.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 60 mg daclatasvir (sem tvíhýdróklóríð).
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir
Icelandic: HEITI LYFS Daklinza 30 mg töflur daclatasvir
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 90 mg daclatasvir (sem tvíhýdróklóríð).
English: With cirrhosis**
Icelandic: Með skorpulifur**
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.
Icelandic: Daklinza 60 mg filmuhúðaðar töflur eru ljósgrænar, tvíkúptar fimmhyrndar töflur með „BMS“ á annarri hliðinni og „215“ á hinni.
English: What Daklinza contains The active substance is daclatasvir.
Icelandic: Virka innihaldsefnið er daclatasvir.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/001 28 tablets (calendar pack) EU/1/14/939/002 28 x 1 tablet
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/939/001 28 töflur (dagatalspakkning)
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with clarithromycin, telithromycin or other strong inhibitors of CYP3A4.
Icelandic: Skammt Daklinza á að minnka í 30 mg einu sinni á dag við samhliða gjöf clarithromycins, telithromycins eða annarra öflugra CYP3A4 hemla.
English: Treatment discontinuation in patients with inadequate on-treatment virologic response during treatment with Daklinza, peginterferon alfa and ribavirin It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR); therefore discontinuation of treatment is recommended in these patients.
Icelandic: Ólíklegt er að sjúklingar með ófullnægjandi veirufræðilega svörun meðan á meðferðinni stendur nái viðvarandi veirufræðilegri svörun (SVR) því er mælt með að meðferð sé hætt hjá þessum sjúklingum, HCV RNA viðmið sem gefa til kynna að hætta skuli meðferð (þ.e. reglur um stöðvun meðferðar) koma fram í töflu
English: AUC: 0.98 (0.83, 1.15) Cmax: 1.03 (0.84, 1.25) Cmin: 1.06 (0.88, 1.29)
Icelandic: ↔ Daclatasvir AUC: 0,98 (0,83; 1,15) Cmax: 1,03 (0,84; 1,25) Cmin: 1,06 (0,88; 1,29)
English: Patients assigned to daclatasvir 60 mg once-daily treatment group who had HCV RNA <LLOQ at Week 4 and undetectable at Week 10 were then randomised to receive another 12 weeks of daclatasvir 60 mg + pegIFN/RBV or placebo + pegIFN/RBV for a total treatment duration of 24 weeks.
Icelandic: 10 var síðan slembiraðað og fengu daclatasvir 60 mg + pegIFN/RBV í 12 vikur til viðbótar eða lyfleysu + pegIFN/RBV í 24 vikur.
English: ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
Icelandic: Rifampicin 600 mg einu sinni á dag (daclatasvir 60 mg stakur skammtur)
English: Administration of Daklinza with any of these calcium channel blockers may result in increased concentrations of daclatasvir.
Icelandic: Samhliða gjöf Daklinza og einhverra þessara kalsíumgangaloka getur aukið þéttni daclatasvirs.
English: Rilpivirine
Icelandic: Rilpivirin
English: SEDATIVES
Icelandic: Meðferðarsvið
English: See section 4.
Icelandic: Arfgerð 4
English: If you can become pregnant, use effective contraception during and for 5 weeks after your treatment with Daklinza.
Icelandic: Konur á barneignaraldri eiga að nota örugga getnaðarvörn meðan á meðferð með Daklinza stendur og í 5 vikur eftir að henni er lokið.
English: ↔ Daclatasvir ↔ Maraviroc
Icelandic: ↔ Maraviroc
English: The pharmacokinetics of daclatasvir following a single 60 mg oral dose were studied in non-HCV infected subjects with renal impairment.
Icelandic: Lyfjahvörf daclatasvirs eftir stakan 60 mg skammt til inntöku voru rannsökuð hjá einstaklingum með skerta nýrnastarfsemi en ekki með HCV smit.
English: AUC: 1.12 (1.02, 1.23) Cmax: 1.07 (0.99, 1.16)
Icelandic: ↔ Norgestrel AUC: 1,12 (1,02; 1,23) Cmax: 1,07 (0,99; 1,16)
English: P-gp inhibition by daclatasvir
Icelandic: P-gp af völdum daclatasvirs:
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with ketoconazole or other strong inhibitors of CYP3A4.
Icelandic: Skammt Daklinza á að minnka í 30 mg einu sinni á dag þegar það er gefið ásamt ketoconazoli eða öðrum öflugum CYP3A4 hemlum.
English: Table 4: Interactions and dose recommendations with other medicinal products
Icelandic: Milliverkanir og leiðbeiningar um skammta samhliða öðrum lyfjum
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/939/003 28 töflur (dagatalspakkning)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/005 28 tablets (calendar pack) EU/1/14/939/006 28 x 1 tablet
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/939/005 28 töflur (dagatalspakkning)
English: In clinical studies of Daklinza in combination with sofosbuvir with or without ribavirin, 2% of patients had Grade 3 haemoglobin decreases; all of these patients received Daklinza + sofosbuvir + ribavirin.
Icelandic: Í klínískum rannsóknum með Daklinza í samsettri meðferð með sofosbuviri með eða án ribavarins voru 2% sjúklinga með 3. stigs lækkun blóðrauða.
English: IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
Icelandic: Cyclosporin 400 mg stakur skammtur (daclatasvir 60 mg einu sinni á dag)
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs).
Icelandic: Samhliða notkun amíódaróns var takmörkuð í klíníska fasanum við þróun sofosbuvir ásamt veirulyfjum með beina verkun.
English: HCV Treatmentnaïve
Icelandic: VEIRUHEMLANADI LYF, HCV
English: Daklinza 60 mg film-coated tablets
Icelandic: Daklinza 60 mg filmuhúðaðar töflur
English: Genotype 3
Icelandic: Tafla 3:
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir.
Icelandic: Hver filmuhúðuð tafla inniheldur daclatasvirtvíhýdróklóríð sem jafngildir 60 mg af daclatasviri.
English: Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Icelandic: Ekki á að gefa Daklinza samhliða dexamethasoni til altækrar notkunar eða öðrum öflugum CYP3A4 virkjum (sjá kafla 4.3).
English: Palpitations
Icelandic: Takttruflanir
English: Impact of baseline NS5A RAVs on cure rates
Icelandic: Áhrif NS5A RAV við upphaf á lækningarhlutfall
English: If you are unsure of any information in the package leaflets, please contact your doctor or pharmacist.
Icelandic: Ef ekki er ljóst hvernig nota á lyfið skal leita upplýsinga hjá lækninum eða lyfjafræðingi.
English: No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see section 5.2).
Icelandic: Daklinza hjá sjúklingum með skerta nýrnastarfsemi óháð alvarleikastigi (sjá kafla 5.2).
English: Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
Icelandic: Upplýsingar sem styðja meðferð með Daklinza og sofobuvir hjá sjúklingum með arfgerð 2 eru takmarkaðar.
English: AUC: 1.01 (0.95, 1.07) Cmax: 1.11 (1.02, 1.20)
Icelandic: ↔ Ethinylestradiol AUC: 1,01 (0,95; 1,07) Cmax: 1,11 (1,02; 1,20)
English: Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Icelandic: C (HCV) hjá fullorðnum (sjá kafla 4.2, 4.4 og 5.1).
English: AUC: 1.10 (1.01, 1.21) Cmax: 1.06 (0.98, 1.15) Cmin: 1.15 (1.02, 1.30)
Icelandic: ↔ Daclatasvir AUC: 1,10 (1,01; 1,21) Cmax: 1,06 (0,98; 1,15) Cmin: 1,15 (1,02; 1,30)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
Icelandic: Lýsing á útliti Daklinza og pakkningastærðir
English: Expected due to CYP3A4 induction by the antimycobacterial:
Icelandic: Áætlað vegna CYP3A4 virkjunar af völdum lyfs við mýkóbakteríum:
English: Cross-resistance
Icelandic: Krossónæmi
English: HCV replicons expressing daclatasvir-associated resistance substitutions remained fully sensitive to interferon alfa and other anti-HCV agents with different mechanisms of action, such as NS3 protease and NS5B polymerase (nucleoside and non-nucleoside) inhibitors.
Icelandic: HCV afrit sem tjá aminósýruútskiptingar sem tengjast daclatasvir ónæmi voru áfram að fullu næm fyrir interferóni alfa og öðrum lyfjum gegn-HCV með mismunandi verkunarhátt t.d.
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4.
Icelandic: Skammt Daklinza á að auka í 90 mg einu sinni á dag þegar það er gefið samhliða meðalöflugum CYP3A4 virkjum.
English: Daclatasvir administered as a tablet was readily absorbed following multiple oral doses with peak plasma concentrations occurring between 1 and 2 hours.
Icelandic: Daclatasvir í töfluformi frásogast hratt eftir endurtekna skammta til inntöku með hámarksplasmaþéttni eftir 1 til 2 klst.
English: AUC: 1.05 (1.02, 1.08) Cmax: 1.00 (0.92, 1.08) Cmin: 1.10 (1.04, 1.16)
Icelandic: ↔Escitalopram AUC: 1,05 (1,02; 1,08) Cmax: 1,00 (0,92; 1,08) Cmin: 1,10 (1,04; 1,16)
English: Not applicable.
Icelandic: Ekki skráð
English: Expected due to CYP3A4 inhibition by the antibacterial:
Icelandic: Áætlað vegna CYP3A4 hömlunar af völdum bakteríuhemjandi lyfsins:
English: Refer to the respective Summary of Product Characteristics for drug interaction information for other medicinal products in the regimen.
Icelandic: Sjá samantekt á eiginleikum annarra lyfja í meðferðinni varðandi milliverkanaupplýsingar.
English: Do not take Daklinza if you are taking any of the following medicines: phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis dexamethasone, a steroid used to treat allergic and inflammatory diseases medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Icelandic: fenytoin, carbamazepin, oxcarbazepin eða fenobarbital notuð við flogaveiki rifampicin, rifabutin eða rifapentin sýklalyf notuð við berklum dexamethason til altækrar notkunar sem er steri notaður við ofnæmis- og bólgusjúkdómum lyf sem innihalda jóhannesarjurt (Hypericum perforatum, náttúrulyf).
English: SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies.
Icelandic: Tíðni SVR var > 94% í samsettri andretróveirumeðferð sem fól í sér örvaða próteasahemla, bakritahemla sem ekki eru núkleósíð og integrasahemla.
English: Benzodiazepines Midazolam 5 mg single dose (daclatasvir 60 mg once daily)
Icelandic: Midazolam 5 mg stakur skammtur (daclatasvir 60 mg einu sinni á dag)
English: Manufacturer Bristol-Myers Squibb S.r.l.
Icelandic: Framleiðandi Bristol-Myers Squibb S.r.l. Loc.
English: Very common (may affect more than 1 in 10 people): decreased appetite difficulty sleeping headache shortness of breath nausea fatigue flu-like illness, fever itching, dry skin, unusual hair loss or thinning, rash diarrhoea cough joint pain, aching or tender muscles, not caused by exercise, unusual weakness irritability reduction in red blood cells (anaemia), reduction in white blood cells
Icelandic: Mjög algengar (geta komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum) minnkuð matarlyst svefnerfiðleikar höfuðverkur mæði ógleði þreyta flensulík veikindi, hiti kláði, húðþurrkur, óvenjulegt hárlos eða hárþynning, útbrot
English: Interaction not studied.
Icelandic: Milliverkanir hafa ekki verið rannsakaðar.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir
Icelandic: HEITI LYFS Daklinza 90 mg töflur daclatasvir
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir.
Icelandic: Hver filmuhúðuð tafla inniheldur daclatasvirtvíhýdróklóríð sem jafngildir 90 mg af daclatasviri.
English: Frequency
Icelandic: Veirugegnumbrot
English: ANTIVIRALS, HIV or HBV Protease inhibitors (PIs) Atazanavir 300 mg/ritonavir 100 mg once daily (daclatasvir 20 mg once daily)
Icelandic: Atazanavir 300 mg/ritonavir 100 mg einu sinni á dag (daclatasvir 20 mg einu sinni á dag)
English: Strong or moderate inducers of CYP3A4 and P-gp may decrease the plasma levels and therapeutic effect of daclatasvir.
Icelandic: Daclatasvir er hvarfefni CYP3A4, P-gp og flutningspróteins fyrir lífrænar katjónir (OCT)°1. Öflugir eða meðalöflugir CYP3A4 og P-gp virkjar geta dregið úr plasmaþéttni og áhrifum daclatasvirs.
English: Pregnancy and contraception
Icelandic: Meðferð og meðferðarlengd
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
Icelandic: HEITI LYFS Daklinza 60 mg töflur daclatasvir
English: Expected due to CYP3A4 induction by the anticonvulsant:
Icelandic: Áætlað vegna CYP3A4 virkjunar af völdum krampalyfsins:
English: 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).
Icelandic: NS5A RAV við upphaf sem lýst var hér að ofan hafði engin stórvægileg áhrif á lækningarhlutfall hjá sjúklingum sem fengu meðferð með sofosbuvir + daclatasvir +/- ribavirin að undanskildu
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2014
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS
English: Fainting
Icelandic: Dreifing
English: Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily)
Icelandic: Dolutegravir 50 mg einu sinni á dag (daclatasvir 60 mg einu sinni á dag)
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with boceprevir or other strong inhibitors of CYP3A4.
Icelandic: Skammt Daklinza á að minnka í 30 mg einu sinni á dag þegar það er gefið ásamt boceprevir eða öðrum öflugum CYP3A4 hemlum.
English: Patients with cirrhosis
Icelandic: Sjúklingar með skorpulifur
English: AUC: 1.12 (1.06, 1.17) Cmax: 1.06 (0.99, 1.14)
Icelandic: ↔ Norelgestromin AUC: 1,12 (1,06; 1,17) Cmax: 1,06 (0,99; 1,14)
English: Patients should be instructed to swallow the tablet whole.
Icelandic: Töflurnar á að gleypa heilar.
English: HCV genotype:
Icelandic: HCV arfgerð 3
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.
Icelandic: frá því að Daklinza er venjulega tekið, þá á að taka töfluna eins fljótt og mögulegt er.
English: No antagonism of antiviral activity was observed.
Icelandic: Mótverkandi áhrif veiruvirkni komu ekki fram.
English: Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Icelandic: Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium
English: Recommended dose
Icelandic: Ráðlagður skammtur
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.
Icelandic: Daklinza 30 mg filmuhúðaðar töflur eru grænar, tvíkúptar fimmhyrndar töflur með „BMS“ á annarri hliðinni og „213“ á hinni.
English: Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for
Icelandic: Skorpulifur var greind með vefjasýni úr lifur (METAVIR F4) hjá 14 sjúklingum, FibroScan > 14,6 kPa hjá 11 sjúklingum eða FibroTest skor ≥ 0,75 og hlutfall aspartat amínótransferasa (AST): blóðflagnastuðull (APRI) > 2 hjá 7 sjúklingum.
English: ↔ Norelgestromin
Icelandic: Natríumkroskaramellósi
English: NARCOTIC ANALGESICS
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with cobicistat or other strong inhibitors of CYP3A4.
Icelandic: Skammt Daklinza á að minnka í 30 mg einu sinni á dag þegar það er gefið samhliða cobicistat eða öðrum öflugum CYP3A4 hemlum.
English: Table 10: Demographics and baseline characteristics in Study ALLY-2
Icelandic: Lýðfræðilegar upplýsingar og sjúkdómseinkenni við upphaf í ALLY-2 rannsókn
English: CORTICOSTEROIDS Systemic dexamethasone
Icelandic: Dexamethason til altækrar notkunar
English: Expected due to CYP3A4 inhibition by the calcium channel blocker:
Icelandic: Áætlað vegna CYP3A4 hömlunar af völdum kalsíumgangalokans:
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Icelandic: Innan hvers tíðniflokks eru algengustu aukaverkanirnar taldar upp fyrst.
English: Coadministration of Daklinza with St. John's wort or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Icelandic: Ekki á að gefa Daklinza samhliða jóhannesarjurt eða öðrum öflugum CYP3A4 virkjum (sjá kafla 4.3).
English: Expected due to CYP3A4 inhibition by atazanavir/cobicistat: ↑ Daclatasvir
Icelandic: Áætlað vegna CYP3A4 hömlunar af völdum atazanavirs/cobicistats: