natgillin/translations-raw huggingface dataset:
ledsmerter, smertende eller ømme muskler, som ikke skyldes motion Når Daklinza anvendes sammen med sofosbuvir og ribavirin, er følgende bivirkninger blevet 
nausea (feeling sick), diarrhoea, abdominal pain joint pain, aching or tender muscles, not caused by exercise When Daklinza is used together with sofosbuvir and ribavirin, the following side effects have been
* Hovedsageligt interferon-baseret behandling +/-NS3/4 PI. ** Cirrose blev konstateret ved leverbiopsi, FibroScan >14,6 kPa eller FibroTest score ≥0,75 og aspartataminotransferase (ASAT): blodplade-indeks (APRI) >2. 
* Mainly interferon-based therapy +/-NS3/4 PI. ** Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2.
kløe, tør hud, unormalt hårtab eller udtynding af håret, udslæt ledsmerter, smertende eller ømme muskler, som ikke skyldes motion, usædvanlig svaghedsfølelse nedsat mængde røde blodlegemer (anæmi), nedsat mængde hvide blodlegemer 
itching, dry skin, unusual hair loss or thinning, rash joint pain, aching or tender muscles, not caused by exercise, unusual weakness reduction in red blood cells (anaemia), reduction in white blood cells
Tdiligere mislykket behandling med telaprevir eller boceprevir 
Prior telaprevir or boceprevir failures
Den anbefalede dosis af Daklinza er 60 mg en gang dagligt og indtages oralt med eller uden et måltid. 
Posology The recommended dose of Daklinza is 60 mg once daily, to be taken orally with or without meals.
Ovenstående doseringsvejledning for hæmoglobin følges 200 mg hver anden dag Ribavirin seponeres 
Follow guidelines above for haemoglobin 200 mg every other day Discontinue ribavirin
Nukleosid/nukleotid revers transkriptasehæmmere (NRTI'er) 
Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Der forventes ingen klinisk relevant indvirkning på farmakokinetikken af hverken det ene eller det andet lægemiddel ved administration af daclatasvir sammen med nogen af følgende: PDE-5-hæmmere, ACE-hæmmere (f.eks. enalapril), angiotensin II-receptorantagonister (f.eks. losartan, irbesartan, olmesartan, candesartan, valsartan), disopyramid, propafenon, flecainid, mexilitin, kinidin eller 
No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with any of the following: PDE-5 inhibitors, medicinal products in the ACE inhibitor class (e.g. enalapril), medicinal products in the angiotensin II receptor antagonist class (e.g. losartan, irbesartan, olmesartan, candesartan, valsartan), disopyramide, propafenone, flecainide,
Behandlingserfare n N=24 
Treatmentexperienced N=24
På grund af amiodarons lange halveringstid skal der desuden foretages passende overvågning af patienter, som inden for de seneste måneder har fået seponeret amiodaron og skal sættes i behandling med Daklinza i kombination med sofosbuvir. 
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Daklinza in
For daclatasvir-behandlede patienter med HCV-RNA-resultater ved både opfølgningsuge 12 og 24, var konkordansen mellem SVR12 og SVR24 97% for HCV-genotype 1 og 100% for 
For daclatasvirtreated patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance of SVR12 and SVR24 was 97% for HCV genotype 1 and 100% for HCV genotype 4.
Forventes: ↔ Daclatasvir ↔ NRTI 
Expected: ↔ Daclatasvir ↔ NRTI
Doseringsvejledning for ribavirin 
Ribavirin Dosing Guidelines
Hver filmovertrukket tablet indeholder 30 mg eller 60 mg daclatasvir 
Each film-coated tablet contains 30 mg or 60 mg daclatasvir
Blandt behandlingsnaive patienter med HCV-RNA-resultater ved både opfølgningsuge 12 og 24 var konkordansen mellem SVR12 og SVR24 99,5% uanset behandlingsvarighed. 
Among treatment-naïve patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance between SVR12 and SVR24 was 99.5% independent of
Behandlingserfaren* N=51 
Treatmentexperienced* N=51
Patienter med diabetes kan opleve forbedret blodsukkerkontrol efter påbegyndelse af HCV-behandling med direkte virkende antivirale lægemidler, hvilket potentielt kan resultere i symptomatisk hypoglykæmi. 
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment.
Efter flere orale doser af daclatasvir 60 mg en gang dagligt i kombination med peginterferon alfa og ribavirin hos behandlingsnaive patienter med kronisk genotype 1-HCV var gennemsnitlig (CV%) Cmax for daclatasvir 1534 (58) ng/ml, AUC0-24h var 14122 (70) ng•h/ml, og Cmin var 232 (83) ng/ml. 
Following multiple oral doses of daclatasvir 60 mg once daily in combination with peginterferon alfa and ribavirin in treatment-naïve patients with genotype 1 chronic HCV, the geometric mean (CV%) daclatasvir Cmax was 1534 (58) ng/ml, AUC0-24h was 14122 (70) ng•h/ml, and
Tabel 3: Regler for seponering hos patienter, der får Daklinza i kombination med peginterferon alfa og ribavirin med utilstrækkelig virologisk respons under 
Table 3: Treatment stopping rules in patients receiving Daklinza in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
SVR-raten for patienter, der blev behandlet i 8 uger, var lavere end for patienter, som fik 12 ugers behandling, hvilket er vist i 
The SVR rate for patients treated for 8 weeks was lower with this treatment duration as summarized in Table 11.
600 mg dagligt 400 mg dagligt 200 mg dagligt Ribavirin seponeres 
600 mg daily 400 mg daily 200 mg daily Discontinue ribavirin
Disse aktive stoffer omfatter, men er ikke begrænset til phenytoin, carbamazepin, oxcarbazepin, phenobarbital, rifampicin, rifabutin, rifapentin, systemisk dexamethason og naturlægemidlet perikon (Hypericum perforatum). 
These active substances include but are not limited to phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum).
Daclatasvir hæmmer både viral RNA 
Daclatasvir inhibits both viral RNA replication
artralgi, myalgi artralgi, myalgi 
Musculoskeletal and connective tissue disorders arthralgia, myalgia arthralgia, myalgia
Du må ikke amme dit barn under behandling 
You should not breastfeed during
Du må ikke stoppe med at tage Daklinza, medmindre din læge har bedt dig om det. 
Do not stop taking Daklinza unless your
Langtidsdata 
Due date
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. 
Daklinza 30 mg: the film-coated tablet is green, biconvex, pentagonal shape with "BMS" debossed on one side and "213" on the other side.
N]-daclatasvir som intravenøs dosis, var det estimerede distributionsvolumen ved steady-state (Vss) 47 l. In vitro-studier viser, at daclatasvir transporteres aktivt og passivt ind i hepatocytter. 
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.
Fortæl det til lægen eller apotekspersonalet, hvis du tager følgende medicin: amiodaron eller digoxin mod uregelmæssig hjerterytme atazanavir/ritonavir, atazanavir/cobicistat, kombinationstablet med elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat, etravirin, nevirapin eller efavirenz boceprevir eller telaprevir til behandling af hepatitis C-infektion clarithromycin, telithromycin eller erythromycin til behandling af bakterielle infektioner Warfarin og lignende lægemidler, såkaldte vitamin K-antagonister, der anvendes til fortynding af blodet. 
Tell your doctor or pharmacist 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 warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
En behandlingsnaiv patient manglede data for både uge 12 og 24 efter behandlingen. 
One treatment-naïve patient was missing both post-treatment Weeks 12
Forventes: ↔ Daclatasvir ↔ Enfuvirtid 
Expected: ↔ Daclatasvir ↔ Enfuvirtide
Baseret på klinisk vurdering af den enkelte patient kan ribavirin 
Ribavirin may be added based on clinical assessment of an individual patient.
Mødre skal oplyses om, at de ikke må amme deres 
Mothers should be instructed not to breastfeed if they are taking Daklinza.
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. 
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
ALLY-2-studiet 12 ugers behandling HCV-behandlingsnaive N=101 
12 weeks therapy HCV Treatmentnaïve N=101
dabigatranetexilat til forebygelse af blodpropper ketoconazol, itraconazol, posaconazol eller voriconazol til behandling af svampeinfektioner verapamil, diltiazem, nifedipin eller amlodipin til behandling af forhøjet blodtryk rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin eller pravastatin til behandling af for meget kolesterol i blodet p-piller 
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
Det samlede median-HCV-RNA var 6,38 log10 IE/ml, og størstedelen af patienterne (59%) havde IL-28B rs12979860 non-CC-genotyper. 
The overall median HCV RNA was 6.38 log10 IU/mL; the majority of patients (59%) had IL-28B rs12979860 non-CC genotypes.
AUC associeret med denne dosis i hanner er 19 gange større end klinisk AUC-eksponering. 
The AUC associated with this dose in males is 19-fold the clinical
AI444043 var et åbent, enkeltarmsstudie med daclatasvir sammen med pegIFN/RBV hos behandlingsnaive voksne med kronisk HCV-genotype 1-infektion, 
AI444043 was an open-label, single-arm study of daclatasvir with pegIFN/RBV in treatment-naïve adults with chronic HCV genotype 1 infection who were co-infected
AUC: 1,10 (1,05; 1,15) Cmax: 0,95 (0,89; 1,02) Cmin: 1,17 (1,10; 1,24) 
Cmax: 0.95 (0.89, 1.02) Cmin: 1.17 (1.10, 1.24)
Tabel 15: Oversigt over observerede nyopståede HCV-NS5A-substitutioner under behandling eller followup hos behandlede non-SVR12 forsøgspersoner med 
Table 15: Summary of noted newly emergent HCV NS5A substitutions on treatment or during follow-up in treated non-SVR12 subjects infected with HCV genotypes 1
Dalkoncentrationerne for PK for peginterferon alfa hos patienter, som fik peginterferon alfa, ribavirin og patienter, som fik peginterferon alfa, 
PK trough levels for peginterferon alfa in patients who received peginterferon alfa, ribavirin, and daclatasvir were received peginterferon alfa, ribavirin,
Cmax og AUC af total-daclatasvir (frit og proteinbundet lægemiddel) var lavere hos forsøgspersoner med nedsat leverfunktion. 
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
Patienter, som oprindeligt blev placeret i behandlingsgruppen, der fik placebo og patienter i daclatasvir-gruppen, som ikke nåede HCV-RNA <LLOQ ved uge 4 og ikke-detekterbart HCV-RNA ved uge 10 fortsattte med pegIFN/RBV og gennemførte 48 ugers behandling. 
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
Daklinza administreres i 24 uger i kombination med 24-48 ugers behandling - Hvis HCV-RNA er ikke-detekterbart ved både behandlingsuge 4 og 12, bør alle 3 komponenter i - Hvis der opnås ikke-detekterbart HCV-RNA, men ikke både ved behandlingsuge 4 og 12, bør Daklinza seponeres ved uge 24, og peginterferon alfa og ribavirin bør fortsætte i i alt 48 uger. 
Daklinza is given for 24 weeks, in combination with 24-48 weeks of peginterferon alfa and ribavirin: - If HCV RNA is undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for a total duration of 24 weeks.
Tabel 6: Behandlingsresultater, daclatasvir i kombination med sofosbuvir, HCV-genotype 1 i 
Table 6: Treatment outcomes, daclatasvir in combination with sofosbuvir, HCV genotype 1 in
Behandlingsvarigheden vil afhænge af, om du tidligere er blevet behandlet for hepatitis C-infektion, din levers tilstand og, hvilken anden medicin du skal tage sammen med Daklinza. 
infection, the condition of your liver, and what other medicines you will take with Daklinza.
↔ Ethinylestradiol AUC: 1,01 (0,95; 1,07) 
↔ Ethinylestradiol AUC: 1.01 (0.95, 1.07) Cmax: 1.11 (1.02, 1.20)
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 
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
Forventes på grund af antimykobakterielle midlers induktion af CYP3A4: 
Expected due to CYP3A4 induction by the anticonvulsant:
Hvis det er nødvendigt at afbryde behandlingen med andre behandlingskomponenter på grund af bivirkninger, må Daklinza ikke gives 
If treatment interruption of components in the regimen is necessary because of adverse reactions, Daklinza must There are no virologic treatment stopping rules that apply to the combination of Daklinza with
Stop med at tage Daklinza og fortæl det straks til lægen, hvis du bliver 
If you become pregnant, stop taking Daklinza and tell your doctor immediately.
Patienternes demografiske data og vigtigste sygdomskarakteristika ved baseline er vist i 
Patient demographics and baseline disease characteristics are summarised in Table 10.
** Cirrose blev konstateret ved hjælp af leverbiopsi (METAVIR F4) hos 14 patienter, FibroScan >14,6 kPa hos 11 patienter eller FibroTest score ≥0,75 og aspartataminotransferase (ASAT): indeks for trombocytratio (APRI) >2 hos 7 patienter. 
* Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a ** Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for 11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2 for 7 patients.
Tabel 7: Behandlingsresultater, daclatasvir i kombination med sofosbuvir i 24 uger, behandlingsnaive patienter med HCV-genotype 2 eller 3 i AI444040-studiet 
Table 7: Treatment outcomes, daclatasvir in combination with sofosbuvir for 24 weeks, treatment-naïve patients with HCV genotype 2 or 3 in Study AI444040
Er du i tvivl, så spørg lægen eller 
If you have any questions about your medicines, please ask your doctor or
Daklinza + sofosbuvir + ribavirin i 12 uger Daklinza + sofosbuvir +/- ribavirin i 24 uger Daklinza + sofosbuvir +/- ribavirin i 24 uger (se pkt. 
Daklinza + sofosbuvir + ribavirin for 12 weeks Daklinza + sofosbuvir +/- ribavirin for 24 weeks
kvalme, diarre, abdominalsmerter udslæt, alopeci, pruritus, 
Skin and subcutaneous tissue disorders rash, alopecia, pruritus,
Udløbsdatoen er den 
The expiry date refers to the last day of that month.
Tabel 9: Behandlingsresultater for daclatasvir i kombination med sofosbuvir og ribavirin i 12 uger hos patienter med cirrose eller recidiv af HCV efter levertransplantation. 
Table 9: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks, patients with cirrhosis or HCV recurrence after liver transplantation,
Den sofosbuvir-resistensassocierede substitution S282T opstod kun hos 1 non-SVR12 patient med 
The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient Emergent daclatasvir resistance-associated substitutions have been shown to persist for 3 years posttreatment and beyond for patients treated with daclatasvir-based regimens.
Daklinza 30 mg filmovertrukne tabletter Daklinza 60 mg filmovertrukne tabletter daclatasvir 
Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets daclatasvir
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. 
Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with "BMS" on one
Dosisjustering af Daklinza er ikke nødvendig hos patienter med hvilken som helst grad af 
No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see
Responderende (SVR12) Ikke-responderende (non 
Non-responder (non-SVR12) Virologic failure Virologic breakthrough
Daklinza + sofosbuvir +/- ribavirin i 24 uger (se pkt. 
Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see section 5.1)
Samtidig infektion med HCV/hiv (ALLY-2) 
All 3 HCV/HIV co
Daclatasvirs hæmning af OATP1B1 og 
Inhibition of OATP 1B1 and BCRP by
Hos patienter, som fik daclatasvir 60 mg 
In patients who received daclatasvir
Daklinza 30 mg filmovertrukne tabletter Grøn bikonveks pentagonal tablet, der måler 7,2 mm x 7,0 mm og er mærket med “BMS” på den ene 
Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with "BMS" on one side
** Cirrose-status blev ikke rapporteret for fire patienter i daclatasvir + pegIFN/RBV guppen. 
* Patients who had missing data at follow-up Week 12 were considered responders if their next available ** Cirrhosis status was not reported for four patients in the daclatasvir + pegIFN/RBV group.
Ingen 
Other None
antibakterielle middels hæmning af 
CARDIOVASCULAR AGENTS Antiarrhythmics
Blod og lymfesystem insomni, irritabilitet insomni hovedpine svimmelhed, migræne svimmelhed, migræne dyspnø, funktionsdyspnø, hoste, tilstoppet næse diarre, opkastning, abdominalsmerter, gastroøsofageal reflukssygdom, obstipation, mundtørhed, 
Respiratory, thoracic and mediastinal disorders dyspnoea, dyspnoea exertional, cough, nasal diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Seponering af Daklinza, peginterferon alfa og ribavirin 
Discontinue Daklinza, peginterferon alfa and ribavirin Discontinue Daklinza, peginterferon alfa and ribavirin
Tabel 14: Behandlingsresultater, daclatasvir i kombination med peginterferon alfa og ribavirin (pegIFN/RBV), behandlingsnaive patienter med HCV-genotype 4 Studie AI444010 daclatasvir + pegIFN/RBV N=12 
Table 14: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4
Fordeling 
Elimination
En patient med HCV-genotype 2-infektion manglede data for både uge 12 og 24 efter behandlingen. 
One patient with HCV genotype 2 infection was missing both post
Tabel 13: Behandlingsresultater, daclatasvir i kombination med sofosbuvir og ribavirin i 24 uger, patienter med HCV-genotype 3 med cirrose i ALLY-3C-studiet Behandlingsnaiv N=54 
Table 13: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 24 weeks, HCV genotype 3 patients with cirrhosis in Study ALLY-3C Treatment-naïve N=54
Recidivraten var ca. 15% og var ens hos patienter med Child-Pugh A, B og C. 
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.
Patienter, der opnåede virologisk respons [ikke-detekterbart HCV-RNA ved uge 4 og 12], afsluttede behandlingen efter 24 uger, mens patienter, som ikke opnåede virologisk respons, 
Patients achieving virologic response [HCV RNA undetectable at weeks 4 and 12] completed therapy after 24 weeks while those who did not achieve virologic response received an additional 24 weeks of treatment with pegIFN/RBV, to complete a total of 48 weeks of study therapy.
Tabletformuleringens absolutte biotilgængelighed er 67%. 
The absolute bioavailability
LÆGEMIDLETS NAVN Daklinza 60 mg tabletter 
NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
4.5 for dosisanbefalinger sammen med antivirale hiv-midler. 
For dosing recommendations with HIV antiviral agents, refer to section 4.5.
- phenytoin, carbamazepin, oxcarbazepin eller phenobarbital, bruges til at behandle epileptiske anfald - rifampicin, rifabutin eller rifapentin, antibiotika mod tuberkulose - dexamethason, et steroidhormon, der anvendes mod allergiske reaktioner og betændelsessygdomme - medicin, der indeholder perikon (Hypericum perforatum, et naturlægemiddel). 
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).
Hos patienter, som fik daclatasvir 60 mg tablet oralt efterfulgt af 100 μg [13C,15N]-daclatasvir som intravenøs dosis, var total-clearance 
In patients who received daclatasvir 60 mg tablet orally followed by 100 μg [
Der foreligger kun begrænsede data til at understøtte behandling af genotype 2-infektion med 
Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
LÆGEMIDLETS NAVN Daklinza 30 mg tabletter 
NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir
LÆGEMIDLETS NAVN Daklinza 30 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 60 mg daclatasvir (som dihydrochlorid). 
Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 30 mg daclatasvir (som dihydrochlorid). 
Each film-coated tablet contains 30 mg of daclatasvir (as dihydrochloride).
Tabel 13: Behandlingsresultater, daclatasvir i kombination med sofosbuvir og ribavirin i 24 uger, patienter med HCV-genotype 3 med cirrose i ALLY-3C-studiet 
Table 13: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 24 weeks, HCV genotype 3 patients with cirrhosis in Study ALLY-3C Treatmentexperienced N=24
Tabel 12: Behandlingsresultater, daclatasvir i kombination med sofosbuvir i 12 uger, patienter med HCV-genotype 3 i ALLY-3-studiet 
Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3 Treatment-naïve N=101
Genotype 1a Genotype 1b Genotype 2 Genotype 3 N=301 
HCV genotype: 1a
Spørg lægen eller apotekspersonalet, hvis du har spørgsmål om din medicin. 
If you have any questions, ask your doctor or pharmacist.
LÆGEMIDLETS NAVN Daklinza 60 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg film-coated tablets daclatasvir
Dosis af Daklinza bør reduceres til 30 mg en gang dagligt ved samtidig administration af potente CYP3A4-hæmmere. 
The dose of Daklinza should be reduced to 30 mg once daily when coadministered with strong inhibitors of CYP3A4.
Forventes på grund perikons induktion ↓ Daclatasvir 
Expected due to inhibition of P-gp by