FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products transported by P-gp in the intestine While paritaprevir, ritonavir and dasabuvir are in vitro inhibitors of P-gp, no significant change was observed in the exposure of the P-gp substrate digoxin when administered with Viekirax and dasabuvir.
Danish: Skønt paritaprevir, ritonavir og dasabuvir er P-gp-hæmmere in vitro, blev der ikke observeret nogen signifikant ændring i eksponeringen for P-gp-substratet digoxin, når det blev administreret sammen med Viekirax og dasabuvir.
English: NA No dose adjustment is necessary for duloxetine.
Danish: Dosisjustering er ikke nødvendig for duloxetin.
English: OTHER
Danish: Andet
English: Ritonavir plasma concentrations increased when renal function was reduced: Cmax and AUC values were 26% to 42% higher, 48% to 80% higher and 66% to 114% higher in subjects with mild, moderate and severe renal impairment, respectively.
Danish: Plasmakoncentrationen af ritonavir steg hos forsøgspersoner med nedsat nyrefunktion: Cmax og AUC var henholdsvis 26-42 %, 48-80 % og 66-114 % højere hos forsøgspersoner med let, moderat og svært nedsat nyrefunktion.
English: Following a single 25 mg dose of 14C- ombitasvir approximately 90% of the radioactivity was recovered in faeces and 2% in urine.
Danish: Efter en enkeltdosis 14C-ombitasvir 25 mg blev ca. 90 % af radioaktiviteten udskilt i fæces og 2 % i urinen.
English: Sirolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax + dasabuvir.
Danish: Sirolimus 2 mg blev doseret alene, 0,5 mg administreret med Viekirax + dasabuvir.
English: Severe renal impairment or ESRD includes CKD Stage 4 defined as eGFR <30-15 mL/min/1.73 m2 or CKD Stage 5 defined as <15 mL/min/1.73 m2 or requiring haemodialysis.
Danish: Behandling: Viekirax og dasabuvir med eller uden ribavirin i 12 eller 24 uger Alvorlig nedsat nyrefunktion eller ESRD omfatter CKD-stadium 4 defineret som eGFR <30-15 ml / min / 1,73 m2 eller CKD-stadium 5 defineret som <15 ml / min / 1,73 m2 eller hæmodialyse krævende.
English: Mechanism: CYP3A4/OA TP1B inhibition
Danish: Mekanisme: Hæmning af CYP3A4/OA TP1B
English: SVR12 for genotype 4-infected, subjects who were treatment-naïve or previously treated with pegIFN/RBV in PEARL I
Danish: SVR12 for genotype 4-smittede forsøgspersoner, der var behandlingsnaive eller tidligere behandlet med pegIFN/RBV i PEARL I
English: Levothyroxine
Danish: Levothyroxin
English: Side effects when taking Viekirax with dasabuvir:
Danish: Bivirkninger ved indtagelse af Viekirax sammen med dasabuvir:
English: Liver transplant subjects with cirrhosis were dosed with Viekirax and dasabuvir with RBV (GT1a for 24 weeks [n=4], GT1b for 12 weeks [n=2]).
Danish: Levertransplanterede forsøgspersoner med cirrose blev doseret med Viekirax og dasabuvir med RBV (GT1a i 24 uger [n = 4], GT1b i 12 uger [n = 2]).
English: Co-administration of Viekirax and dasabuvir with medicinal products that are moderate or strong enzyme inducers is expected to decrease ombitasvir, paritaprevir, ritonavir and dasabuvir plasma concentrations and reduce their therapeutic effect.
Danish: Samtidig administration af Viekirax med dasabuvir og lægemidler, der er moderate eller stærke enzyminducere, forventes at reducere plasmakoncentrationen af ombitasvir, paritaprevir og dasabuvir og deres terapeutiske virkning.
English: Elderly No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis af Viekirax hos ældre patienter (se pkt.
English: Examples of contraindicated enzyme inducers are provided in section 4.3.
Danish: Eksempler på kontraindicerede enzym-inducere er angivet i pkt.
English: Refer to the prescribing information of encorafenib for details on co-administration with strong CYP3A inhibitors.
Danish: Se encorafenibs produktresumé vedrørende detaljer om samtidig administration med stærke CYP3A-hæmmere.
English: ↑ fluticasone
Danish: ↑ fluticason
English: Clinical monitoring and dose reduction is recommended for angiotensin receptor blockers when coadministered with Viekirax with or without dasabuvir.
Danish: Klinisk overvågning og dosisreduktion anbefales for angiotensin-receptor blokkere ved samtidig administration med Viekirax med eller uden dasabuvir.
English: ↑ levothyroxine
Danish: ↑ levothyroxin
English: Refer to the prescribing information of ibrutinib for details on co-administration with strong CYP3A inhibitors.
Danish: Se ibrutinibs produktresumé vedrørende detaljer om samtidig administration med stærke CYP3A-hæmmere.
English: Ombitasvir and paritaprevir do not inhibit organic anion transporter (OAT1) in vivo and are not expected to inhibit organic cation transporters (OCT1 and OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Danish: Ombitasvir og paritaprevir hæmmer ikke den organiske aniontransporter (OAT1) in vivo og forventes ikke at hæmme de organiske kationtransportere OCT1 og OCT2, den organiske aniontransporter (OAT3) eller multilægemiddel- og toksinekstrusionsproteinerne (MATE1 og MATE2K) ved klinisk relevante koncentrationer.
English: Following a 200 mg 14C -paritaprevir dose with 100 mg ritonavir, approximately 88% of the radioactivity was recovered in faeces with limited radioactivity (8.8%) in urine.
Danish: Efter en dosis på 200 mg 14C-paritaprevir plus 100 mg ritonavir blev ca. 88 % af radioaktiviteten udskilt i fæces og en begrænset andel (8,8 %) i urinen.
English: NNRTIs other than rilpivirine (efavirenz, etravirine and nevirapine) are contraindicated (see section 4.3).
Danish: Bortset fra rilpivirin er non-nukleosid revers transkriptase-hæmmere (efavirenz, etravirin og nevirapin) kontraindicerede (se pkt.
English: Medicinal products metabolised by CYP3A4
Danish: Lægemidler, der metaboliseres af CYP3A4
English: Increase in dasabuvir exposure is possibly due to CYP2C8 inhibition and increase in paritaprevir possibly due to OATP1B1 inhibition by gemfibrozil.
Danish: Mekanisme: Øget dasabuvireksponering skyldes muligvis gemfibrozils CYP2C8hæmning, og øget paritaprevireksponering skyldes muligvis gemfibrozils OATP1B1hæmning.
English: Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Danish: Viekirax 12,5 mg / 75 mg / 50 mg filmovertrukne tabletter
English: 24 weeks
Danish: 24 uger.
English: Each carton contains 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Danish: Hver æske indeholder 56 tabletter (multipakning med 4 æsker a hver 14 tabletter).
English: Viekirax and dasabuvir with RBV for 12 weeks n/N % 95% CI
Danish: Viekirax og dasabuvir + RBV i 12 uger n/N % 95 %-KI
English: Paritaprevir is an inhibitor of the hepatic uptake transporters OATP1B1 and OATP1B3, and paritaprevir and ritonavir are inhibitors of OATP2B1.
Danish: Paritaprevir hæmmer de hepatiske uptake-transportere OATP1B1 og OATP1B3, og paritaprevir og ritonavir hæmmer OATP2B1.
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: Viekirax with or without dasabuvir was also evaluated without ribavirin in 18 GT1a- and GT4-infected patients; no adverse events of anaemia were seen in these subjects.
Danish: Hos 18 GT1aog GT4-inficerede patienter blev Viekirax med eller uden dasabuvir også undersøgt uden ribavirin; der blev ikke set anæmi-bivirkninger hos disse patienter.
English: Enzalutamide
Danish: Enzalutamid
English: Co-administration of Viekirax with or without dasabuvir together with medicinal products that are substrates of BCRP may increase plasma concentrations of these transporter substrates, potentially requiring dose adjustment/clinical monitoring.
Danish: Samtidig administration af Viekirax med eller dasabuvir sammen med lægemidler, der er substrater af BCRP, kan øge plasmakoncentrationen af disse substrater og nødvendiggøre dosisjustering/klinisk overvågning.
English: Treatment with atazanavir + Viekirax without dasabuvir is not recommended-(↑ paritaprevir).
Danish: Behandling med atazanavir plus Viekirax uden dasabuvir anbefales ikke (↑
English: • fusidic acid
Danish: • fusidinsyre
English: The persistence of paritaprevir, ombitasvir, and dasabuvir resistance-associated amino acid substitutions in NS3, NS5A, and NS5B, respectively, was assessed in genotype 1a-infected subjects in Phase 2b trials.
Danish: Persistensen af paritaprevir-, ombitasvir- og dasabuvir-resistensrelaterede aminosyresubstitutioner i henholdsvis NS3, NS5A og NS5B blev undersøgt hos genotype 1a-smittede forsøgspersoner i fase 2bstudier.
English: A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with Viekirax.
Danish: Det anbefales at afbryde behandlingen med pitavastatin/fluvastatin midlertidigt, så længe Viekirax-behandlingen pågår.
English: Tacrolimus or sirolimus whole blood concentrations should be monitored upon initiation and throughout co-administration with Viekirax and dasabuvir and the dose and/or dosing frequency should be adjusted as needed.
Danish: Koncentrationen af tacrolimus eller sirolimus i helblod bør overvåges ved initiering og under samtidig administration med Viekirax og dasabuvir og dosis og/eller doseringshyppighed bør justeres efter behov.
English: Darunavir, dosed 800 mg once daily, if administered at the same time as Viekirax and dasabuvir, can be used in the absence of extensive PI resistance (darunavir exposure lowered).
Danish: Darunavir 800 mg én gang dagligt kan bruges i kombination med Viekirax og dasabuvir, hvis administration er på samme tid, og der ikke er udtalt PI-resistens (nedsat darunavir-eksponering).
English: CALCIUM CHANNEL BLOCKERS Amlodipine
Danish: CALCIUMANTAGONISTER Amlodipin
English: ↑ repaglinide
Danish: ↑ repaglinid
English: A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment with Viekirax.
Danish: Det anbefales at afbryde behandlingen med fluvastatin og pitavastatin midlertidigt, så længe Viekirax-behandlingen pågår.
English: Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong inhibitors of CYP3A4 is expected to increase paritaprevir plasma concentrations and must not be co-administered with Viekirax (see section 4.5).
Danish: Samtidig administration af Viekirax med eller uden dasabuvir og lægemidler, der er stærke hæmmere af CYP3A4, forventes at øge paritaprevir plasmakoncentration og må derfor ikke administreres samtidig med Viekirax (se pkt.
English: Genotype 1b, without cirrhosis or with compensated cirrhosis
Danish: Genotype 1b, uden cirrose eller med kompenseret cirrose
English: Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL increase in
Danish: Samlet SVR12 HCV genotype 1a HCV genotype 1b Resultat for patienter uden SVR12 VF under behandlinga Recidiv Andetb 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: PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design:
Danish: PEARL III - genotype 1b, behandlingsnaive, uden cirrose Design:
English: Ciclosporin 100 mg dosed alone, 10 mg administered with Viekirax and 30 mg administered with Viekirax + dasabuvir.
Danish: Ciclosporin 100 mg doseret alene, 10 mg administreret sammen med Viekirax og 30 mg administreret sammen med Viekirax med dasabuvir.
English: Caution is advised.
Danish: Der bør udvises forsigtighed.
English: Viekirax is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.3 and 5.2).
Danish: Viekirax er kontraindiceret hos patienter med moderat til svært nedsat leverfunktion (Child-Pugh B eller C) (se pkt.
English: ↑ dabigatran etexilate
Danish: ↑ dabigatran etexilat
English: Clinical Comments without dasabuvir
Danish: Klinisk kommentar dasabuvir
English: Table 20.
Danish: Tabel 20.
English: Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Danish: Følgende dasabuvirbehandlingsrelaterede varianter i NS5B blev observeret hos 34 forsøgspersoner: M414T, G554S, S556G, G558R eller D559G/N.
English: • St. John's Wort (Hypericum perforatum)
Danish: • prikbladet perikon (hypericum perforatum)
English: 2 mg single dose7
Danish: 2 mg enkeltdosis7
English: In genotype 1a, substitutions F43L, R155K, A156T, and D168A/F/H/V/Y in HCV NS3 reduced susceptibility to paritaprevir.
Danish: I genotype 1a reducerede substitutionerne F43L, R155K, A156T og D168A/H/V/Y i HCV-NS3 følsomheden over for paritaprevir.
English: Take two tablets in the morning
Danish: Oral anvendelse Tag to tabletter om morgenen
English: These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin, lomitapide to lower blood cholesterol carbamazepine, phenytoin, phenobarbital for epilepsy cisapride for relieving certain stomach problems clarithromycin, fusidic acid, rifampicin, telithromycin for bacterial infections colchicine in patients who have severe problems with their liver or kidneys for treating gout attacks conivaptan for making the sodium levels in the blood normal efavirenz, etravirine, lopinavir/ritonavir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat for HIV infection apalutamide,enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinyloestradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception itraconozole, ketoconozole, posaconazole, voriconazole for fungal infections midazolam, triazolam (when taken by mouth) for anxiety or trouble sleeping mitotane for symptoms of malignant tumours of the adrenal glands pimozide, lurasidone for schizophrenia quetiapine for schizophrenia, bipolar disorder and major depressive disorder quinidine for abnormal heart rhythms or malaria ranolazine for chronic angina (chest pain)
Danish: Amiodaron, disopyramid, dronedaron mod uregelmæssig hjerterytme astemizol, terfenadin mod allergisymptomer - fås i håndkøb atorvastatin, lovastatin, simvastatin, lomitapid mod forhøjet kolesterol carbamazepin, phenytoin, phenobarbital mod epilepsi cisaprid til lindring af visse maveproblemer clarithromycin, fusidinsyre, rifampicin, telithromycin mod bakterieinfektioner colchicin hos patienter, som har alvorlige problemer med deres lever eller nyrer mod urinsyregigt conivaptan til normalisering af natrium i blodet efavirenz, etravirin, lopinavir/ritonavir, saquinavir, tipranavir, nevirapin, indinavir, cobicistat mod hiv-infektion apalutamid, enzalutamid mod prostatakræft ergotamin, dihydroergotamin mod migræne ergonovin, methylergometrin i forbindelse med fødsler ethinyløstradiol-holdige lægemidler som f.eks. de fleste p-piller og p-ringe som prævention itraconozol, ketoconazol, posaconazol, voriconazol mod svampeinfektioner midazolam, triazolam (når de tages gennem munden)
English: While no dose adjustment is necessary for digoxin, appropriate monitoring of serum digoxin levels is ombitasvir
Danish: Selvom dosisjustering af digoxin ikke er nødvendig, anbefales det at overvåge
English: The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively.
Danish: Paritaprevirs gennemsnitlige EC50-værdi mod replikoner indeholdende NS3 fra et panel af behandlingsnaive genotype 1a- og 1b-isolater i HCV-replikoncellekulturanalysen var henholdsvis 0,86 nM (interval: 0,43-1,87 nM; n = 11) og 0,06 nM (interval: 0,030,09 nM; n = 9).
English: Dose normalized sirolimus ratios are shown for interaction with Viekirax + dasabuvir.
Danish: Dosisnormaliserede sirolimus -ratioer er vist for interaktion med Viekirax + dasabuvir.
English: Viekirax and dasabuvir with/without ribavirin for 12 or 24 Weeks N = 200a
Danish: Viekirax og dasabuvir med/eller uden ribavirin i 12 eller 24 uger N = 200a
English: 200 mg once daily/300 mg once daily
Danish: 200 mg én gang dagligt/ 300 mg én gang dagligt
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Viekirax with or without dasabuvir is required.
Danish: Det anbefales at nedsætte colchicin-dosen eller afbryde colchicinbehandlingen hos patienter med normal nyre- og leverfunktion, hvis behandling med Viekirax med eller uden dasabuvir er nødvendig.
English: PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis
Danish: PEARL II - genotype 1b, pegIFN + RBV-erfarne, uden cirrose
English: Viekirax in combination with ribavirin is recommended in genotype 4 infection.
Danish: Til patienter med genotype 4-infektion anbefales Viekirax i kombination med ribavirin.
English: Concomitant use of Viekirax and glucocorticoids, particularly long-term use, should only be initiated if the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.5).
Danish: Brug af glukokortikoider sammen med Viekirax, navnlig i længere tid, må kun finde sted, hvis de potentielle fordele opvejer risikoen for systemiske glukokortikoid-bivirkninger (se pkt.
English: salmeterol for asthma sildenafil when used to treat a heart and lung disorder called “pulmonary arterial hypertension”
Danish: salmeterol mod astma sildenafil mod forhøjet blodtryk i lungekredsløbet ("pulmonal arteriel hypertension")
English: Viekirax and dasabuvir for 8 weeks
Danish: Viekirax og dasabuvir i 8 uger
English: In genotype 1b, substitutions L28T, L31F/V, as well as Y93H alone or in combination with L28M, R30Q, L31F/M/V or P58S in HCV NS5A reduced susceptibility to ombitasvir.
Danish: I genotype 1b reducerede substitutionerne L28T, L31F/V samt Y93H alene eller i kombination med L28M, R30Q, L31F/M/V eller P58S i HCV-NS5A følsomheden over for ombitasvir.
English: Ethinyloestradiol is contraindicated in combination with Viekirax (see sections 4.3 and 4.4).
Danish: Ethinyløstradiol er kontraindiceret i kombination med Viekirax (se pkt.
English: All clinical trials with ombitasvir, paritaprevir and ritonavir have been conducted following administration with food.
Danish: I alle de kliniske studier med ombitasvir, paritaprevir og ritonavir blev forsøgslægemidlet administreret sammen med mad.
English: Pack-size of 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Danish: Pakningsstørrelser a 56 tabletter (multipakning med 4 æsker, som hver indeholder 14 tabletter).
English: Tell your doctor or pharmacist if you are taking, have recently taken and before starting any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: HCV Genotype 1b Viekirax and dasabuvir
Danish: HCV genotype 1b Viekirax og dasabuvir
English: In Part 1b, all subjects received Viekirax and dasabuvir with ribavirin for 12 weeks.
Danish: I del 1b blev alle forsøgspersoner behandlet med Viekirax og dasabuvir med ribavirin i 12 uger.
English: Geometric mean Cmax, AUC of multiple doses of Viekirax 150 mg/100 mg/25 mg once daily with dasabuvir 250 mg twice daily with food in healthy volunteers
Danish: Geometrisk gennemsnit af Cmax og AUC for multiple doser af Viekirax 150 mg/100 mg/25 mg én gang dagligt i kombination med dasabuvir 250 mg to gange dagligt sammen med mad hos raske forsøgspersoner
English: Mechanism: Increase in paritaprevir exposures may be due to inhibition of CYP3A/efflu x transporters by lopinavir and higher dose of ritonavir
Danish: Mekanisme: Øget paritaprevireksponering kan skyldes lopinavirs og den højere ritonavirdosis' hæmning af CYP3A/ efflukstransportere.
English: The maximum daily dose of rosuvastatin should be 10 mg (see section 4.4).
Danish: Den daglige rosuvastatindosis må højst være 10 mg (se pkt.
English: The mean EC50 of ombitasvir against replicons containing NS5A from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.66 pM (range 0.35 to 0.88 pM; n=11) and 1.0 pM (range 0.74 to 1.5 pM; n=11), respectively.
Danish: Ombitasvirs gennemsnitlige EC50-værdi mod replikoner indeholdende NS5A fra et panel af behandlingsnaive genotype 1a- og 1b-isolater i HCV-replikoncellekulturanalysen var henholdsvis 0,66 pM (interval: 0,35-0,88 pM; n = 11) og 1,0 pM (interval: 0,741,5 pM; n = 11).
English: Treated subjects (N=68) had a median age of 58 years (range: 32-77 years); 83.8% were male; 58.8% were Black; 73.5% of subjects were infected with HCV GT1a; 75.0%% had Stage 5 CKD and 69.1% were on haemodialysis.
Danish: De behandlede patienter (N = 68) havde en median alder på 58 år (interval: 32-77 år); 83,8% var mænd; 58,8% var sorte; 73,5% af patienterne var inficeret med HCV GT1a; 75,0 % havde CKD-stadium 5 og 69,1% var i hæmodialyse.
English: Medicinal products that inhibit CYP3A4
Danish: Lægemidler, der hæmmer CYP3A4
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 + dasabuvir.
English: Adverse drug reactions identified with Viekirax in combination with dasabuvir with and without ribavirin
Danish: Bivirkninger, der er set ved Viekirax i kombination med dasabuvir med eller uden ribavirin
English: EFFECT Cmax
Danish: Cmax
English: NA ↔ ombitasvir/paritaprevir/dasabuvir (based on the crossstudy comparison)
Danish: ↔ ombitasvir/paritaprevir/dasabuvir (baseret på en sammenligning på tværs af studier)
English: Concomitant use of Viekirax and fluticasone particularly long-term use, should only be initiated if the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Danish: Samtidig brug af Viekirax og fluticason navnlig i længere tid, må kun finde sted, hvis de potentielle fordele opvejer risikoen for systemiske glukokortikoidbivirkninger (se pkt.
English: No dose adjustment of Viekirax is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis af Viekirax hos patienter med let, moderat eller svært nedsat nyrefunktion eller hos patienter i dialyse med nyresygdom i slutstadiet (se pkt.
English: Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir
Danish: Viekirax 12,5 mg / 75 mg / 50 mg tabletter ombitasvir / paritaprevir / ritonavir
English: Take two tablets in the morning.
Danish: Oral anvendelse Tag to tabletter om morgenen.
English: ↑ itraconazole ↑ posaconazole ↑ paritaprevir ↑ dasabuvir
Danish: ↑ itraconazol ↑ posaconazol ↑ paritaprevir ↑ dasabuvir
English: HCV ANTIVIRALS Sofosbuvir
Danish: ANTIVIRALT MIDDEL MOD HEPATITIS C-VIRUS Sofosbuvir
English: Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
Danish: Viekirax er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis C (CHC) hos voksne (se pkt.
English: Caution should be used and dose decrease maybe needed for repaglinide when administered with Viekirax with or without dasabuvir.
Danish: Der bør udvises forsigtighed og reduktion af dosis kan være nødvendig for repaglinid ved samtidig administration med Viekirax med eller uden dasabuvir