FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: Du må ikke tage Daklinza sammen med følgende medicin: phenytoin, carbamazepin, oxcarbazepin eller phenobarbital til behandling af epileptiske anfald rifampicin, rifabutin eller rifapentin, antibiotika til behandling af tuberkulose dexamethason, et steroid til behandling af allergiske reaktioner og betændelsessygdomme medicin, der indeholder perikon (Hypericum perforatum, et naturlægemiddel).
English: Table 1: Recommended treatment for Daklinza interferon-free combination therapy
Danish: Tabel 1: Anbefalinger for Daklinza-kombinationsbehandling uden interferon Patientpopulation*
English: Administration of Daklinza with erythromycin may result in increased concentrations of daclatasvir.
Danish: Administration af Daklinza sammen med erythromycin kan medføre øget koncentration af daclatasvir.
English: Coadministration of Daklinza with carbamazepine, oxcarbazepine, phenobarbital, phenytoin or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Danish: Samtidig administration af Daklinza og carbamazepin, oxcarbazepin, phenobarbital, phenytoin eller andre potente CYP3A4-induktorer er kontraindiceret (se pkt.4.3).
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).
Danish: Daklinza er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis C-virusinfektion (HCV) hos voksne (se pkt.
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.
Danish: De behandlede patienter havde en gennemsnitsalder på 49 år (interval: 20 til 71); 77% of patienterne var hvide; 19% var sorte/afroamerikanere; 4% var latinamerikanere.
English: Moderate inducers of CYP3A4
Danish: Moderate CYP3A4-induktorer
English: Toxicology
Danish: Toksikologi
English: Respiratory, thoracic and mediastinal disorders common dyspnoea, dyspnoea exertional, cough, nasal congestion
Danish: Luftveje, thorax og mediastinum almindelig dyspnø, funktionsdyspnø, hoste, tilstoppet næse
English: No dose adjustment of Daklinza or sofosbuvir is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller sofosbuvir.
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.
Danish: De 211 patienter havde en gennemsnitsalder på 54 år (interval: 20 til 70); 83% var hvide; 12% var sorte/afroamerikanere; 2% var asiatere og 20% var latinamerikanere.
English: Expected due to CYP3A4 inhibition by atazanavir/cobicistat: ↑ Daclatasvir
Danish: Forventes på grund af atazanavirs/cobicistats hæmning af CYP3A4: ↑ Daclatasvir
English: ANTIFUNGALS Ketoconazole 400 mg once daily (daclatasvir 10 mg single dose)
Danish: ANTIMYKOTIKA Ketoconazol 400 mg en gang dagligt (daclatasvir 10 mg enkeltdosis)
English: Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3
Danish: Tabel 12: Behandlingsresultater, daclatasvir i kombination med sofosbuvir i 12 uger, patienter med HCV-genotype 3 i ALLY-3-studiet
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).
Danish: Der er iagttaget svær bradykardi og hjerteblok ved anvendelse af Daklinza i kombination med sofosbuvir samtidig med amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
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
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): nedsat appetit søvnbesvær, irritabilitet svimmelhed migræne åndenød, hoste, tilstoppet næse hedeture tør hud, unormalt hårtab eller udtynding af håret, udslæt, kløe diarre, opkastning, mavesmerter, forstoppelse, halsbrand, unormalt meget luft i maven eller tarmen mundtørhed ledsmerter, smertende eller ømme muskler, som ikke skyldes motion
English: INFORMATION IN BRAILLE Daklinza 30 mg
Danish: INFORMATION I BRAILLESKRIFT Daklinza 30 mg
English: No dose adjustment of Daklinza or tenofovir is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller tenofovir.
English: INFORMATION IN BRAILLE Daklinza 60 mg
Danish: INFORMATION I BRAILLESKRIFT Daklinza 60 mg
English: INFORMATION IN BRAILLE Daklinza 90 mg
Danish: INFORMATION I BRAILLESKRIFT Daklinza 90 mg
English: Daclatasvir is an inhibitor of P-gp, OATP 1B1 and BCRP.
Danish: Daclatasvir hæmmer P-gp, OATP 1B1 og BCRP.
English: Darunavir 800 mg/ritonavir 100 mg once daily (daclatasvir 30 mg once daily)
Danish: Darunavir 800 mg/ritonavir 100 mg en gang dagligt (daclatasvir 30 mg en gang dagligt)
English: Prior telaprevir or boceprevir failures daclatasvir + sofosbuvir N=70
Danish: Tdiligere mislykket behandling med telaprevir eller boceprevir daclatasvir + sofosbuvir N=70
English: Light green biconvex round of dimension 10.16 mm diameter, embossed tablet with "BMS" on one side and "011" on the other side.
Danish: Lysegrøn bikonveks rund tablet, der måler 10,16 mm i diameter og er mærket med “BMS” på den ene side og “011” på den anden side.
English: On-treatment virologic failure
Danish: Virologisk svigt under behandling
English: Daklinza is to be taken orally with or without meals.
Danish: Til oral anvendelse, med eller uden et måltid.
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.
Danish: Grøn bikonveks pentagonal tablet, der måler 7,2 mm x 7,0 mm og er mærket med “BMS” på den ene side og “213” på den anden side.
English: Daklinza + sofosbuvir + ribavirin for 12 weeks or
Danish: Daklinza + sofosbuvir + ribavirin i 12 uger eller
English: Cirrhotic cohort N=60
Danish: ALLY-1-studiet Cirrosekohorte N=60
English: Ribavirin Dosing Guidelines The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients
Danish: Dosis af ribavirin er vægtbaseret ved kombination med Daklinza (1.000 eller 1.200 mg hos patienter på henholdsvis <75 kg eller ≥75 kg).
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.
Danish: Lysegrøn bikonveks pentagonal tablet, der måler 9,1 mm x 8,9 mm og er mærket med “BMS” på den ene side og “215” på den anden side.
English: Virologic breakthrough
Danish: Virologisk gennembrud
English: Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC genotypes.
Danish: De fleste patienter i dette studie (71%, herunder 98% med tidligere mislykket PI-behandling) havde IL28B rs12979860 non-CC-genotyper.
English: Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily)
Danish: Digoxin 0,125 mg en gang dagligt (daclatasvir 60 mg en gang dagligt)
English: Each 90-mg film-coated tablet contains 173 mg of lactose (as anhydrous).
Danish: Hver 90 mg filmovertrukket tablet indeholder 173 mg lactose (vandfri).
English: ↑ Norbuprenorphine AUC: 1.62 (1.30, 2.02) Cmax: 1.65 (1.38, 1.99) Cmin: 1.46 (1.12, 1.89)
Danish: ↑ Norbuprenorphin AUC: 1,62 (1,30; 2,02) Cmax: 1,65 (1,38 ; 1,99) Cmin: 1,46 (1,12; 1,89)
English: CORTICOSTEROIDS Systemic dexamethasone
Danish: KORTIKOSTEROIDER Systemisk dexamethason Interaktion ikke undersøgt.
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.
Danish: Medianalderen var 55 år (aldersspænd: 24 til 73); 90% af patienterne var hvide; 4% var sorte/afroamerikanske; 5% var asiatiske; 16% var latinamerikanske.
English: No dose adjustment of Daklinza or simeprevir is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller simeprevir.
English: 400 mg daily
Danish: 400 mg dagligt
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.
Danish: Daklinza 60 mg: den filmovertrukne tablet er lysegrøn, bikonveks, pentagonal-formet og mærket med “BMS” på den ene side og “215” på den anden side.
English: No dose adjustment of Daklinza or methadone is required.
Danish: Dosisjustering af Daklinza eller methadon er ikke nødvendig.
English: Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2
Danish: Tabel 11: Behandlingsresultater for daclatasvir i kombination med sofosbuvir hos patienter med samtidig HCV/hiv-infektion.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Danish: ADMINISTRATIONSMETODE Bristol-Myers Squibb Pharma EEIG
English: Lopinavir 400 mg/ritonavir 100 mg twice daily (daclatasvir 30 mg once daily)
Danish: Lopinavir 400 mg/ritonavir 100 mg to gange dagligt (daclatasvir 30 mg en gang dagligt)
English: Benzodiazepines Midazolam 5 mg single dose (daclatasvir 60 mg once daily)
Danish: Benzodiazepiner Midazolam 5 mg enkeltdosis (daclatasvir 60 mg en gang dagligt)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (PERFORATED) TEXT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ENKELTDOSISBLISTER (PERFORERET) TEKST
English: ↔ R-methadone AUC: 1.08 (0.94, 1.24) Cmax: 1.07 (0.97, 1.18) Cmin: 1.08 (0.93, 1.26)
Danish: ↔ R-methadon AUC: 1,08 (0,94; 1,24) Cmax: 1,07 (0,97; 1,18) Cmin: 1,08 (0,93; 1,26)
English: Coadministration of Daklinza with rifampicin, rifabutin, rifapentine or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Danish: Samtidig administration af Daklinza og rifampicin, rifabutin, rifapentin eller andre potente induktorer af CYP3A4 er kontraindiceret (se pkt.
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see section 5.1) Recurrent HCV infection post-liver transplant (GT 1, 3 or 4) Patients without cirrhosis
Danish: 5.1) Recidiv af HCV-infektion efter levertransplantation (GT 1, 3 eller 4) Patienter uden cirrose
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
Danish: Tabel 9: Behandlingsresultater for daclatasvir i kombination med sofosbuvir og ribavirin i 12 uger hos patienter med cirrose eller recidiv af HCV efter levertransplantation.
English: No dose adjustment of Daklinza or rilpivirine is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller rilpivirin.
English: If you take any of these medicines, tell your doctor immediately.
Danish: Fortæl det straks til lægen, hvis du tager et eller flere af disse lægemidler.
English: Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets Daklinza 90 mg film-coated tablets daclatasvir
Danish: Daklinza 30 mg filmovertrukne tabletter Daklinza 60 mg filmovertrukne tabletter Daklinza 90 mg filmovertrukne tabletter daclatasvir
English: Each 60-mg film-coated tablet contains 116 mg of lactose (as anhydrous).
Danish: Hver 60 mg filmovertrukket tablet indeholder 116 mg lactose (vandfri).
English: Ribavirin Dosing Guideline
Danish: Doseringsvejledning for ribavirin
English: Increase in gastric pH
Danish: Intragastrisk pH-stigning
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Danish: 4.2 for anbefalede behandlinger med forskellige HCV-genotyper.
English: Laboratory abnormalities
Danish: Afvigelser ved laboratoriefund
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
Danish: Daklinza 90 mg: den filmovertrukne tablet er lysegrøn, bikonveks, rund og mærket med “BMS” på den ene side og “011” på den anden side.
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.
Danish: Dosis af Daklinza bør reduceres til 30 mg en gang dagligt, når det administreres samtidigt med atazanavir/ritonavir, atazanavir/cobicistat eller andre potente CYP3A4-hæmmere.
English: No dose adjustment of Daklinza or warfarin is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller warfarin.
English: ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifampicin 600 mg en gang dagligt (daclatasvir 60 mg enkeltdosis)
English: IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
Danish: IMMUNOSUPPRESSIVA Ciclosporin 400 mg enkeltdosis (daclatasvir 60 mg en gang dagligt)
English: Daklinza 30 mg and 60 mg film-coated tablets
Danish: Daklinza 30 mg og 60 mg filmovertrukne tabletter 30 måneder
English: Telaprevir 500 mg q12h (daclatasvir 20 mg once daily)
Danish: Telaprevir 500 mg hver 12. time (daclatasvir 20 mg en gang dagligt)
English: Inhibition of OATP 1B1 and BCRP by daclatasvir
Danish: Daclatasvirs hæmning af OATP1B1 og BCRP
English: Each 30-mg film-coated tablet contains 58 mg of lactose (as anhydrous).
Danish: Hver 30 mg filmovertrukket tablet indeholder 58 mg lactose (vandfri).
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4.
Danish: Dosis af Daklinza bør øges til 90 mg en gang dagligt ved samtidig administration af moderate CYP3A4-induktorer.
English: No dose adjustment of Daklinza or raltegravir is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller raltegravir.
English: Expected due to CYP3A4 induction by etravirine or nevirapine:
Danish: Forventes på grund af etravirins eller nevirapins hæmning af CYP3A4:
English: HCV Treatmentnaïve
Danish: HCV-behandlingsnaive
English: ↑ Dolutegravir AUC: 1.33 (1.11, 1.59) Cmax: 1.29 (1.07, 1.57) Cmin: 1.45 (1.25, 1.68)
Danish: AUC: 1,33 (1,11; 1,59) Cmax: 1,29 (1,07; 1,57) Cmin: 1,45 (1,25; 1,68)
English: Simeprevir 150 mg once daily (daclatasvir 60 mg once daily)
Danish: Simeprevir 150 mg en gang daligt (daclatasvir 60 mg en gang dagligt)
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Danish: Tabel over bivirkninger Bivirkningerne er anført i Tabel 5 efter behandlingsregime, systemorganklasse og hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til <1/100), sjælden
English: With cirrhosis
Danish: Med cirrose
English: Tacrolimus 5 mg single dose (daclatasvir 60 mg once daily)
Danish: Tacrolimus 5 mg enkeltdosis (daclatasvir 60 mg en gang dagligt)
English: Telaprevir 750 mg q8h (daclatasvir 20 mg once daily)
Danish: Telaprevir 750 mg hver 8. time (daclatasvir 20 mg en gang dagligt)
English: No dose adjustment of Daklinza or escitalopram is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller escitalopram.
English: You may have to take your other medicines for different lengths of time.
Danish: Du vil muligvis skulle tage din anden medicin længere eller kortere tid end Daklinza.
English: If you accidentally take more Daklinza tablets than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Danish: Kontakt lægen eller nærmeste hospital, hvis du ved en fejl har taget flere Daklinza-tabletter end lægen har anvist.
English: Calcium channel blockers Diltiazem
Danish: Calciumantagonister Diltiazem
English: Expected due to CYP3A4 induction by dexamethasone:
Danish: Forventes på grund af dexamethasons induktion af CYP3A4:
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), talk to your doctor before taking Daklinza.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter (f.eks. lactose).
English: Expected due to CYP3A4 and P-gp inhibition by verapamil:
Danish: Forventes på grund af verapamils hæmning af CYP3A4 og P-gp:
English: No dose adjustment of Daklinza is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza.
English: Skin and subcutaneous tissue disorders common rash, alopecia, pruritus, dry skin Musculoskeletal and connective tissue disorders common arthralgia, myalgia arthralgia, myalgia
Danish: Knogler, led, muskler og bindevæv almindelig artralgi, myalgi artralgi, myalgi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/005 28 tablets (calendar pack) EU/1/14/939/006 28 x 1 tablet
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/939/005 28 tabletter (kalenderpakning) EU/1/14/939/006 28 x 1 tablet
English: The Cmax and AUC of total daclatasvir (free and protein-bound drug) were lower in subjects with hepatic impairment; however, hepatic impairment did not have a clinically significant effect on the free drug concentrations of daclatasvir (see section 4.2).
Danish: Cmax og AUC af total-daclatasvir (frit og proteinbundet lægemiddel) var lavere hos forsøgspersoner med nedsat leverfunktion.
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir.
Danish: Hver filmovertrukket tablet indeholder daclatasvirdihydrochlorid svarende til 30 mg daclatasvir.
English: In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, the total clearance was
Danish: Hos patienter, som fik daclatasvir 60 mg tablet oralt efterfulgt af 100 µg [
English: No dose adjustment of Daklinza or enfuvirtide is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller enfuvirtid.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/001 28 tablets (calendar pack) EU/1/14/939/002 28 x 1 tablet
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/939/001 28 tabletter (kalenderpakning) EU/1/14/939/002 28 x 1 tablet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/939/003 28 tabletter (kalenderpakning) EU/1/14/939/004 28 x 1 tablet
English: Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Danish: Samtidig administration af Daklinza og systemisk dexamethason eller andre potente CYP3A4-induktorer er kontraindiceret (se pkt.
English: ↔ Lopinavir* AUC: 1.15 (0.77, 1.72) Cmax: 1.22 (1.06, 1.41) Cmin: 1.54 (0.46, 5.07)
Danish: AUC: 1,15 (0,77; 1,72) Cmax: 1,22 (1,06; 1,41) Cmin: 1,54 (0,46; 5,07)
English: Discontinue ribavirin
Danish: ↔ Ribavirin
English: Daklinza 90 mg film-coated tablets
Danish: Daklinza 90 mg filmovertrukne tabletter
English: ↔ Daclatasvir AUC: 1.41 (1.32, 1.50) Cmax: 0.77 (0.70, 0.85)
Danish: AUC: 1,41 (1,32; 1,50) Cmax: 0,77 (0,70; 0,85)
English: Daklinza 30 mg film-coated tablets
Danish: Daklinza 30 mg filmovertrukne tabletter
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.
Danish: Daklinza 30 mg: den filmovertrukne tablet er grøn, bikonveks, pentagonal-formet og mærket med “BMS” på den ene side og “213” på den anden side.
English: 600 mg daily
Danish: 600 mg dagligt
English: Daklinza + sofosbuvir + ribavirin for 12 weeks (see section 5.1)
Danish: Daklinza + sofosbuvir + ribavirin i 12 uger (se pkt.
English: Induction of CYP3A4 by efavirenz
Danish: Efavirenzs induktion af CYP3A4
English: ↔ Daclatasvir AUC: 1.40 (1.29, 1.53) Cmax: 1.04 (0.94, 1.15) Cmin: 1.56 (1.41, 1.71)
Danish: AUC: 1,40 (1,29; 1,53) Cmax: 1,04 (0,94; 1,15) Cmin: 1,56 (1,41; 1,71)
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with clarithromycin, telithromycin or other strong inhibitors of CYP3A4.
Danish: Dosis af Daklinza bør reduceres til 30 mg en gang dagligt, når det administreres sammen med clarithromycin, telithromycin eller andre potente CYP3A4-hæmmere.
English: If you take more Daklinza than you should
Danish: Hvis du har taget for meget Daklinza
English: LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Rosuvastatin 10 mg single dose (daclatasvir 60 mg once daily)
Danish: LIPIDSÆNKENDE MIDLER HMG-CoA-reduktasehæmmere Rosuvastatin 10 mg enkeltdosis (daclatasvir 60 mg en gang dagligt)
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir.
Danish: Hver filmovertrukket tablet indeholder daclatasvirdihydrochlorid svarende til 60 mg daclatasvir.
English: Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily)
Danish: Integrasehæmmere Dolutegravir 50 mg en gang dagligt (daclatasvir 60 mg en gang dagligt)
English: oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum).
Danish: Disse aktive stoffer omfatter, men er ikke begrænset til phenytoin, carbamazepin, oxcarbazepin, phenobarbital, rifampicin, rifabutin, rifapentin, systemisk dexamethason og naturlægemidlet perikon (Hypericum perforatum).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 30 mg daclatasvir (som dihydrochlorid).
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir.
Danish: Hver filmovertrukket tablet indeholder daclatasvirdihydrochlorid svarende til 90 mg daclatasvir.
English: Follow guidelines above for haemoglobin
Danish: Ovenstående doseringsvejledning for hæmoglobin følges
English: No cirrhosis
Danish: Cirrosekohorte
English: AUC: 1.37 (1.24, 1.52) Cmax: 1.30 (1.03, 1.64) Cmin: 1.17 (1.03, 1.32)
Danish: ↑ Buprenorphin AUC: 1,37 (1,24; 1,52) Cmax: 1,30 (1,03 ; 1,64) Cmin: 1,17 (1,03; 1,32)
English: ↔ Daclatasvir AUC: 1.15 (1.07, 1.24) Cmax: 0.67 (0.61, 0.74)
Danish: AUC: 1,15 (1,07; 1,24) Cmax: 0,67 (0,61; 0,74)
English: ↔ Ribavirin AUC: 0.94 (0.80, 1.11) Cmax: 0.94 (0.79, 1.11) Cmin: 0.98 (0.82, 1.17)
Danish: AUC: 0,94 (0,80; 1,11) Cmax: 0,94 (0,79; 1,11) Cmin: 0,98 (0,82; 1,17)
English: ↔ Cyclosporine AUC: 1.03 (0.97, 1.09) Cmax: 0.96 (0.91, 1.02)
Danish: AUC: 1,03 (0,97; 1,09) Cmax: 0,96 (0,91; 1,02)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg of daclatasvir (as dihydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 90 mg daclatasvir (som dihydrochlorid).
English: Do not take Daklinza if you are allergic to daclatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet) if you are taking (by mouth or other ways that affect the whole body) 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).
Danish: hvis du tager et eller flere af følgende lægemidler (gennem munden eller på andre måder, der påvirker hele kroppen) - phenytoin, carbamazepin, oxcarbazepin eller phenobarbital, bruges til at behandle epileptiske anfald - rifampicin, rifabutin eller rifapentin, antibiotika mod tuberkulose