FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who are taking ethinylestradiol-containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Viekirax and dasabuvir therapy (see sections 4.3 and 4.5).
Danish: Patienter, der tager ethinylestradiol-holdige lægemidler (dvs. de fleste kombinerede p-piller og p-ringe), skal skifte til en alternativ præventionsmetode (f.eks. prævention med gestagen alene eller ikkehormonelle metoder), inden de starter behandling med Viekirax og dasabuvir (se pkt.
English: What Viekirax contains
Danish: Viekirax indeholder:
English: 5 mg single dose and other vitamin K antagonists
Danish: 5 mg enkeltdosis og andre vitamin Kantagonister
English: Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4).
Danish: Samtidig brug med fluvastatin og pitavastatin anbefales ikke (se pkt.
English: Number of Responders at the End of Treatment AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
Danish: AFP* < 20 ng/ml, trombocyttal ≥ 90 x 109/l og albumin ≥ 35 g/l før behandling
English: These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3).
Danish: Forhøjet ALAT sås signifikant hyppigere i den undergruppe, der brugte ethinylestradiol-holdige lægemidler som f.eks. kombinerede p-piller eller p-ringe (6 ud af 25 forsøgspersoner) (se pkt.
English: SVR12 for HCV Genotype 4-Infected Subjects with Compensated Cirrhosis Ombitasvir + Paritaprevir + Ritonavir with RBV 12 Weeks
Danish: SVR12 for HCV Genotype 4-smittede forsøgspersoner med kompenseret cirrose Ombitasvir + Paritaprevir + Ritonavir with RBV 12 uger
English: Treated subjects had a median age of 51 years (range: 26 to 64); 65.8% were male and 5.3% were Black.
Danish: De behandlede forsøgspersoner havde en median alder på 51 år (interval: 26-64), 65,8 % var mænd og
English: Other CYP2C9 substrates (NSAIDs (e.g. ibuprofen), antidiabetics (e.g. glimepiride, glipizide) are not expected to require dose adjustments.
Danish: Andre CYP2C9-substrater (NSAID-præparater (f.eks. ibuprofen), antidiabetika (f.eks. glimepirid, glipizid))forventes ikke at nødvendiggøre dosisjustering.
English: b. Other includes early drug discontinuation not due to virologic failure missing HCV RNA values in the
Danish: b. 'Andet' omfatter tidlig stop i behandlingen som ikke skyldes virologisk svigt og manglende HCV-rna værdier i SVR12-vinduet).
English: The efficacy and safety of Viekirax in combination with dasabuvir with and without ribavirin was evaluated in seven Phase 3 clinical trials, including two trials exclusively in subjects with cirrhosis (Child-Pugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Danish: Virkningen af og sikkerheden ved Viekirax i kombination med dasabuvir med og uden ribavirin blev undersøgt i syv kliniske fase 3-studier, hvoraf to udelukkende omfattede patienter med cirrose (ChildPugh A), og som tilsammen omfattede over 2.360 patienter med kronisk hepatitis C genotype 1-infektion (se tabel 6).
English: Polyvinyl alcohol (E1203) Polyethylene glycol 3350 Talc (E553b) Titanium dioxide (E171) Iron oxide red (E172)
Danish: Filmovertræk Polyvinylalkohol (E1203) Polyethylenglykol 3350 Talkum (E553b) Titaniumdioxid (E171) Rød jernoxid (E172)
English: In subjects receiving Viekirax and dasabuvir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
Danish: Hos de forsøgspersoner, der fik Viekirax og dasabuvir uden ribavirin, var de typisk indberettede bivirkninger associeret til ribavirin (f.eks. kvalme, søvnløshed, anæmi) mindre hyppige og ingen forsøgspersoner (0/588) stoppede behandlingen permanent på grund af bivirkninger.
English: The safety profile of Viekirax and dasabuvir was similar in subjects without cirrhosis, and with compensated cirrhosis with the exception of increased rates of transient hyperbilirubinemia when ribavirin was part of the regimen.
Danish: Sikkerhedsprofilen for Viekirax og dasabuvir var den samme som hos patienter uden cirrose og med kompenseret cirrose med undtagelse af øget hyppighed af forbigående hyperbilirubinæmi, når ribavirin var en del af behandlingsregimet.
English: The recommended oral dose of Viekirax is two 12.5 mg / 75 mg / 50 mg tablets once daily with food.
Danish: Den anbefalede orale dosis Viekirax er to 12,5 mg/75 mg/50 mg-tabletter én gang dagligt sammen med mad.
English: 25 mg once daily administered in the morning, with food
Danish: 25 mg én gang dagligt taget om morgenen med mad2
English: CYP3A substrates evaluated in drug interaction studies which may require dose adjustment and/or clinical monitoring include (see Table 2) cyclosporine, tacrolimus, amlodipine, rilpivirine and alprazolam.
Danish: CYP3A-substrater, der er undersøgt i lægemiddelinteraktionsstudier, og som kan nødvendiggøre dosisjustering og/eller klinisk monitorering, omfatter (se tabel 2) ciclosporin, tacrolimus, amlodipin, rilpivirin og alprazolam.
English: Thirty four subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Danish: Fireogtredive forsøgspersoner (29 med HCV genotype 1a-infektion og 5 med HCV genotype 1binfektion), som ikke havde fået behandling for HCV-infektion efter transplantationen, og som havde en METAVIR-fibrose-score på F2 eller lavere, blev rekrutteret.
English: Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/ paracetamol or diazepam.
Danish: Lægemiddelinteraktioner blev undersøgt for Viekirax med dasabuvir-regimet, men ikke for Viekirax uden dasabuvir-regimet, administreret sammen med carbamazepin, furosemid, zolpidem, darunavir to gange dagligt, darunavir (administreret om aftenen), atazanavir (administreret om aftenen), rilpivirin, abacavir/lamivudin, dolutegravir, metformin, sulfamethoxazol/trimethoprim, cyclobenzaprin, carisoprodol, hydrocodon/ paracetamol eller diazepam.
English: • enzalutamide
Danish: • enzalutamid
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 56 (4 packs of 14) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 56 (4 æsker a 14) filmovertrukne tabletter
English: Effect of dasabuvir on paritaprevir/ritonavir and ombitasvir In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
Danish: Indvirkningen af dasabuvir på paritaprevir/ritonavir og ombitasvir Når dasabuvir var til stede, steg eksponeringen for paritaprevir med 50-65 %, mens der ikke sås nogen ændring i eksponeringen for ombitasvir.
English: • Check for side effects of Viekirax or other antiviral medicines your doctor has prescribed for you to use with Viekirax (such as “dasabuvir” and “ribavirin”).
Danish: • se, om der er bivirkninger ved Viekirax eller de andre antivirale lægemidler, som lægen har ordineret sammen med Viekirax (f.eks. dasabuvir og ribavirin).
English: Medicinal products renally excreted via transport proteins Ombitasvir, paritaprevir, and ritonavir do not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate).
Danish: Lægemidler, der udskilles renalt via transportproteiner Ombitasvir, paritaprevir og ritonavir hæmmer ikke den organiske aniontransporter OAT1 in vivo, idet der ikke ses nogen interaktion med tenofovir (OAT1-substrat).
English: Clinical trials in peginterferon+ribavirin-experienced adults
Danish: Kliniske studier med peginterferon/ribavirin-erfarne voksne
English: Low dose ritonavir, which is part of the fixed dose combination Viekirax, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Danish: Lavdosis-ritonavir, der indgår i den faste kombinationsdosering sammen med Viekirax, kan medføre PIresistens hos patienter med samtidig HIV-infektion, der ikke er i antiretroviral behandling.
English: Accumulation is minimal for ombitasvir and approximately 1.5- to 2-fold for ritonavir and paritaprevir.
Danish: Akkumulationen af ombitasvir er minimal, mens akkumulationen af ritonavir og paritaprevir er ca. 1,5-2 gange så stor.
English: • quinidine
Danish: • quinidin
English: PEARL II (open-label)
Danish: PEARL II (ikke-blindet)
English: 4-24 mg/16 mg once daily
Danish: 4-24 mg/16 mg én gang dagligt5
English: Genotype 4, without cirrhosis or with compensated cirrhosis
Danish: Genotype 4, uden cirrose eller med kompenseret cirros
English: Coadministration with enzyme inducers may increase the risk of adverse events and ALT elevations (see Table 2).
Danish: Samtidig administration af enzym-inducere kan øge risikoen for bivirkninger og forhøjet ALAT (se tabel 2).
English: ANTIHISTAMINES Astemizole
Danish: ANTIHISTAMINER Astemizol
English: Patients with severe hepatic impairment (Child-Pugh C) (see section 5.2).
Danish: Patienter med svært nedsat leverfunktion (Child-Pugh C) (se pkt.
English: Expected: ↑ ticagrelor
Danish: Forventet: ↑ ticagrelor
English: Terfenadine
Danish: Terfenadin
English: Viekirax, when co-administered with dasabuvir, combines three direct-acting antiviral agents with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Danish: Ved samtidig administration af Viekirax og dasabuvir kombineres tre direkte virkende antivirale midler med særskilte virkningsmekanismer og ikke-overlappende resistensprofiler, der er målrettet HCV i flere faser af den virale livscyklus.
English: Tacrolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax and 2 mg was administered with Viekirax + dasabuvir.
Danish: Tacrolimus 2 mg doseret alene, 0,5 mg administreret sammen med Viekirax og 2 mg administreret sammen med Viekirax med dasabuvir.
English: Clinical trials in subjects with genotype 4 chronic hepatitis C PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis Design:
Danish: Klinisk studier hos patienter med kronisk hepatitis C genotype 4-infektion PEARL I - genotype 4, behandlingsnaive eller pegIFN + RBV -erfarne uden cirrose Design:
English: A pooled analysis of subjects with genotype 1 HCV infection, who were treated with ombitasvir, paritaprevir, and dasabuvir (a non-nucleotide NS5B inhibitor) with or without ribavirin in the Phase 2b and 3 clinical trials was conducted to explore the association between baseline NS3/4A, NS5A or NS5B substitutions/polymorphisms and treatment outcome in recommended regimens.
Danish: Der blev gennemført en samlet analyse af de forsøgspersoner med genotype 1 HCV-infektion, der blev behandlet med ombitasvir, paritaprevir og dasabuvir (en non-nukleotid NS5B-hæmmer) med eller uden ribavirin i de kliniske fase 2b- og fase 3-studier, for at undersøge sammenhængen mellem NS3/4A-, NS5A- eller NS5B-substitutioner/polymorfismer ved baseline og behandlingsresultatet af de anbefalede regimer.
English: One subject with HCV genotype 1a infection relapsed post-treatment.
Danish: Én forsøgsperson med HCV genotype 1a-infektion fik recidiv efter behandlingen.
English: TURQUOISE III (open-label)
Danish: TURQUOISE III (ikke-blindet)
English: HIV protease inhibitors other than atazanavir and darunavir (e.g., indinavir, saquinavir, tipranavir, lopinavir/ritonavir) are contraindicated (see section 4.3).
Danish: Andre HIV-proteasehæmmere end atazanavir og darunavir (f.eks. indinavir, saquinavir, tipranavir og lopinavir/ritonavir) er kontraindiceret (se pkt.
English: It contains the active substances ombitasvir, paritaprevir and ritonavir.
Danish: Viekirax indeholder de aktive stoffer ombitasvir, paritaprevir og ritonavir.
English: − Tablet film-coating: polyvinyl alcohol (E1203), polyethylene glycol 3350, talc (E553b), titanium dioxide (E171) and red iron oxide (E172).
Danish: − Filmovertræk: polyvinylalkohol (E1203), polyethylenglykol 3350, talkum (E553b), titaniumdioxid (E171), og rød jernoxid (E172),.
English: Other a. These virologic failures appear to have resulted from reinfection based on analyses of baseline and virologic failure samples
Danish: Andet a. På baggrund af prøver fra baseline og virologiske analyser synes disse tilfælde af virologisk svigt at skyldes reinfektion.
English: Not studied.
Danish: Ikke undersøget.
English: See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Danish: 4.2 for doseringsanbefalinger hos patienter med HCV og samtidig HIV-1-infektion.
English: Treatment-naïve pegIFN + RBV experienced Prior relapse Prior partial response Prior null response 100% (32/32) Other pegIFN/RBV failures TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure.
Danish: Behandlingsnaive pegIFN/RBV-erfarne 100 % (91/91) Tidligere recidiv 100 % (33/33) Tidligere delvis respons Tidligere nul respons Andre typer af pegIFN/RBV svigt I ALT +Andre typer af pegIFN/RBV svigt inklusive mindre vel-dokumenteret non-respons, recidiv/virologisk gennembrud eller anden pegIFN svigt.
English: The overall safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV monoinfected subjects.
Danish: Den overordnede sikkerhedsprofil hos forsøgspersoner med HCV og samtidig HIV-1-infektion var den samme som sikkerhedsprofilen hos forsøgspersoner, der kun var smittet med HCV.
English: HIV/HCV co-infected patients
Danish: Patienter med samtidig HIV/HCV-infektion
English: Viekirax + dasabuvir + ribavirin* N = 2,044
Danish: Viekirax med dasabuvir plus ribavirin* N = 2.044
English: Vitamin E polyethylene glycol succinate Propylene glycol monolaurate Sorbitan monolaurate Colloidal anhydrous silica (E551) Sodium stearyl fumarate
Danish: E-vitamin polyethylenglycolsuccinat Propylenglycolmonolaurat Sorbitanmonolaurat Kolloid vandfri silica (E551) Natriumstearylfumarat
English: Dabigatran etexilate
Danish: Dabigatran etexilat
English: Trazodone
Danish: Trazodon
English: Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim
Danish: Mekanisme: Øget dasabuvireksponering skyldes muligvis CYP2C8hæmning af trimethoprim
English: In all seven trials, the Viekirax dose was 25 mg/150 mg/100 mg once daily and the dasabuvir dose was 250 mg twice daily.
Danish: I alle syv studier var Viekirax-dosen 25 mg/150 mg/100 mg én gang dagligt, og dasabuvir-dosen var 250 mg to gange dagligt.
English: In the genotype 1a replicon, the activity of ombitasvir was reduced by 896-, 58- and 243-fold against the M28T/V and H58D substitutions, respectively, and 1326-, 800-, 155-foldand 1675- to 66740- fold by the Q30E/R, L31V and Y93C/H/N substitutions, respectively.
Danish: I genotype 1a-replikonen blev aktiviteten af ombitasvir reduceret med henholdsvis 896, 58 og 243 gange af substitutionerne M28T/V og H58D og med henholdsvis 1.326, 800 og 155 gange samt 1.675-66740 gange af substitutionerne Q30E/R, L31V og Y93C/H/N.
English: NA No dose adjustment required for diazepam; increase dose if clinically indicated.
Danish: med dasabuvir relevant nødvendig for diazepam; øgning af dosis, hvis klinisk indiceret.
English: SVR12 for HIV-1 co-infected Subjects in TURQUOISE-I
Danish: SVR12 for forsøgspersoner med samtidig HIV-1-infektion i TURQUOISE I
English: Viekirax dasabuvir hydrocodone
Danish: Viekirax med dasabuvir hydrocodon
English: − Tablet core: copovidone, vitamin E polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E551), sodium stearyl fumarate.
Danish: − Tabletkerne: copovidon, E-vitamin polyethylenglycolsuccinat, propylenglykolmonolaurat, sorbitanmonolaurat, kolloid vandfri silica(E551), natriumstearylfumarat.
English: ↑ pimozide
Danish: ↑ pimozid
English: NAME OF THE MARKETING AUTHORISATION HOLDER AbbVie Ltd
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AbbVie Ltd
English: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Viekirax with and without dasabuvir and with and without ribavirin.
Danish: Der er efter markedsføring rapporteret om dekompenseret leversygdom og leversvigt, inklusive levertransplantation og dødeligt udfald, hos patienter, som har været behandlet med Viekirax med eller uden dasabuvir og med eller uden ribavirin.
English: 20-120 mg once daily
Danish: 20-120 mg én gang dagligt
English: TURQUOISE II (open-label)
Danish: TURQUOISE II (ikke-blindet)
English: Viekirax and dasabuvir + ribavirin 12 or 24 weeks N = 380 n (%)
Danish: Viekirax og dasabuvir med ribavirin 12 eller 24 uger N = 380 n (%)
English: To be noted, atazanavir should be taken without ritonavir, since ritonavir 100 mg once daily is provided as part of Viekirax.
Danish: Bemærk, at atazanavir skal tages uden ritonavir, da ritonavir 100 mg én gang dagligt indgår i Viekirax doseringen.
English: The pharmacokinetic properties of the combination of Viekirax with dasabuvir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 19 shows mean Cmax and AUC of Viekirax 25 mg/150 mg/100 mg once daily with dasabuvir 250 mg twice daily following multiple doses with food in healthy volunteers.
Danish: De farmakokinetiske egenskaber ved kombinationen af Viekirax og dasabuvir er blevet undersøgt hos raske voksne og hos patienter med kronisk hepatitis C. Tabel 19 viser gennemsnitlig Cmax og AUC for Viekirax 25 mg/150 mg/100 mg én gang dagligt i kombination med dasabuvir 250 mg to gange dagligt efter multiple doser sammen med mad hos raske forsøgspersoner.
English: What Viekirax looks like and contents of the pack Viekirax tablets are pink, oblong film-coated tablets of dimmensions 18.8 mm x 10.0 mm, marked with ‘AV1'.
Danish: Viekirax-tabletterne er lyserøde, aflange filmovertrukne tabletter på 18,8 mm x 10,0 mm præget med "AV1".
English: Viekirax with or without dasabuvir ethinylestradiol
Danish: Viekirax med eller uden dasabuvir ethinylestrad iol
English: ↑ amiodarone
Danish: ↑amiodaron
English: Alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms colchicine for patients whose kidney and liver function test are normal for treating gout attacks or familial Mediterranean fever digoxin, amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain levothyroxine for thyroid problems rilpivirine, darunavir, atazanavir for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems imatinib for the treatment of some cancers of the blood fluvastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol dabigatran to thin the blood fexofenadine for hay fever s-mephenytoin for epilepsy sulfasalazine for inflammatory bowel disease repaglinide for lowering blood sugar erythromycin for bacterial infections steroid or corticosteroid medicines (such as fluticasone)
Danish: Lægemidlet tages/gives alprazolam, diazepam mod angst, panikanfald og søvnbesvær ciclosporin, tacrolimus for at undertrykke immunsystemet cyclobenzaprin, carisoprodol mod muskelkramper colchicin til patienter med normal nyre- og leverfunktionstest mod urinsyregigt eller familiær middelhavsfeber digoxin, amlodipin, nifedipin, valsartan, diltiazem, verapamil, candesartan, losartan mod hjerteproblemer eller forhøjet blodtryk furosemid mod væskeophobning i kroppen hydrokodon mod smerter levothyroxin mod problemer med skjoldbruskkirtlen rilpivirine, darunavir, atazanavir mod hiv-infektion omeprazol, lansoprazol, esomeprazol mod mavesår og andre maveproblemer imatinib til behandling af visse former for kræft i blodet fluvastatin, pitavastatin, pravastatin, rosuvastatin mod forhøjet kolesterol dabigatran til fortynding af blodet fexofenadin mod høfeber s-mephenytoin mod epilepsi sulfasalazin mod inflammatorisk tarmsygdom repaglinid mod forhøjet blodsukker erythromycin mod bakterie-infektion steroider eller binyrebarkhormon (f.eks. fluticason) mod mange forskellige tilstande, herunder alvorlige sygdomme og allergier trazodon mod angst og depression
English: Ethinylestradiol is contraindicated in combination with Viekirax (see sections 4.3 and 4.4).
Danish: Ethinylestradiol er kontraindiceret i kombination med Viekirax (se pkt.
English: 0.035/0.25 mg once daily
Danish: 0,035/0,25 m g én gang
English: Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL
Danish: Recidiv Andet b a. Bekræftet HCV ≥ 25 IE/ml efter HCV-rna < 25 IE/ml under behandling, bekræftet 1 log10 IE/ml stigning i HCV-rna fra nadir eller HCV-rna vedvarende ≥ 25 IE/ml efter mindst 6 ugers behandling.
English: HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine2
Danish: HIV-ANTIVIRALE MIDLER: NON-NUKLEOSID REVERS TRANSKRIPTASE-HÆMMERE Rilpivirin
English: 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Danish: 56 tabletter (multipakning med 4 æsker, som hver indeholder 14 tabletter).
English: CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 12 months post liver transplant
Danish: CORAL-I: behandlingsnaive eller pegIFN + RBV-erfarne med levertransplantation for mindst 12 måneder siden
English: Table 3 lists adverse reactions for which a causal relationship between paritaprevir/ombitasvir/ritonavir, in combination with dasabuvir and/or ribavirin, and the adverse event is at least a reasonable possibility.
Danish: Tabel 3 indeholder en liste over de bivirkninger, hvor det som minimumskriterium er rimeligt sandsynligt, at der er en årsagssammenhæng mellem en given bivirkning og administrationen paritaprevir/ombitasvir/ritonavir i kombination med dasabuvir og/eller ribavirin.
English: NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Viekirax 12,5 mg/75 mg/50 mg filmovertrukne tabletter
English: Candesartan
Danish: Losartan Candesartan
English: Ethinylestradiol-containing oral contraceptives are contraindicated (see section 4.3).
Danish: Ethinylestradiol-holdige præventionsmidler er kontraindicerede (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 12,5 mg ombitasvir, 75 mg paritaprevir og 50 mg ritonavir.
English: Marketing Authorisation Holder AbbVie Ltd
Danish: Indehaver af markedsføringstilladelsen AbbVie Ltd
English: In vitro studies show that ombitasvir, paritaprevir, and ritonavir are not inhibitors of organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Danish: In vitro-studier har vist, at ombitasvir, paritaprevir og ritonavir ikke hæmmer den organiske kationtransporter OCT2, den organiske aniontransporterer OAT3 eller multilægemiddel- og toksinekstrusionsproteinerne MATE1 og MATE2K ved klinisk relevante koncentrationer.
English: No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis af Viekirax hos ældre patienter (se pkt.