natgillin/translations-raw huggingface dataset:
Blandt de 670 behandlede patienter var medianalderen 59 år (interval 21 til 81 år); 77 % af patienterne var mænd; 91 % var hvide; det gennemsnitlige kropsmasseindeks var 28 kg/m2 (interval 18 til 49 kg/m2); 94 % og 6 % havde hhv. genotype 1 og 4 HCV-infektion; tidligere HCV-behandling svigtede hos 78 % af patienterne.
Of the 670 treated patients, the median age was 59 years (range: 21 to 81 years); 77% of the patients were male; 91% were White; mean body mass index was 28 kg/m2 (range: 18 to 49 kg/m2); 94% and 6% had genotype 1 and 4 HCV infection, respectively; 78% of the patients failed a prior HCV therapy.
Behandlingsnaive voksne med eller uden cirrose - ION-1 (studie 0102) - genotype 1 ION-1 var et randomiseret, åbent studie der undersøgte 12 og 24 ugers behandling med ledipasvir/sofosbuvir med eller uden ribavirin hos 865 behandlingsnaive patienter med CHC forårsaget af infektion med HCV af genotype 1, herunder patienter med cirrose (randomiseret 1:1:1:1).
Treatment-naïve adults with or without cirrhosis - ION-1 (study 0102) - Genotype 1 ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC including those with cirrhosis (randomised 1:1:1:1).
Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af Harvoni med amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Ingen dosisjustering af Harvoni eller methadon er nødvendig.
No dose adjustment of Harvoni or methadone is required.
Eksponeringen for den primære metabolit, GS-331007, ved doser, der forårsager bivirkninger, var imidlertid 16 gange (rotter) og 71 gange (hunde) højere end den kliniske eksponering med 400 mg sofosbuvir.
Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at doses which cause adverse effects was 16 times (rat) and 71 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
ANTIMYKOBAKTERIELLE MIDLER Rifampicin (600 mg én gang dagligt)/ ledipasvir (90 mg enkeltdosis)d
ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)d
a. Disse 4 patienter uden cirrose med recidiv havde alle NS5A-polymorfisme forbundet med resistens ved baseline.
24% (4/17)e a These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
Administration af Harvoni sammen med tipranavir (ritonavir-boostet) forventes at nedsætte koncentrationen af ledipasvir og føre til en nedsat terapeutisk virkning af Harvoni.
Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni.
Ribavirin-dosis*
Ribavirin dose*
24 uger (n = 111)
24 weeks (n = 111)
Gennemsnitligt forhold (90 % konfidensinterval) for AUC, Cmax, Cmina,b
AUC, Cmax, Cmina, b
Darunavir boostet med ritonavir (800 mg/ 100 mg én gang dagligt)/ sofosbuvir (400 mg én gang dagligt)
Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ sofosbuvir (400 mg once daily)
Når det gives med elvitegravir/ cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat, forventes Harvoni at øge koncentrationen af tenofovir.
When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Samtidig administration af sådanne lægemidler og Harvoni anbefales ikke (se pkt.
Co-administration of such medicinal products is not recommended with Harvoni (see section 4.5).
d. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
d Patients with missing cirrhosis status were excluded from this subgroup analysis.
Se produktresuméerne for tenofovirdisoproxilfumarat, emtricitabin/tenofovirdisoproxilfumarat eller elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat for anbefalinger om nyreovervågning.
Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Ved koncentrationer, der blev opnået i klinikken, er ledipasvir ikke en hæmmer af levertransportere, herunder OATP 1B1 eller 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug- og toksisk stofekstrusion (MATE) 1-transporter, multidrug resistance protein (MRP) 2 eller MRP4.Sofosbuvir og GS-331007 er ikke hæmmere af lægemiddeltransporterne P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 og GS-331007 er ikke en hæmmer af OAT1, OCT2 og MATE1.
At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4.
Ingen dosisjustering af Harvoni eller atazanavir (ritonavir-boostet) er nødvendig.
No dose adjustment of Harvoni or atazanavir (ritonavir boosted) is required.
Ingen dosisjustering af Harvoni eller efavirenz/ emtricitabin/ tenofovirdisoproxilfumarat er nødvendig.
No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required.
Raltegravir (400 mg to gange dagligt)/ sofosbuvir (400 mg én gang dagligt)d
Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d
Lægemidler, der er stærke P-gp-inducere (carbamazepin, phenobarbital, phenytoin, rifampicin, rifabutin og perikon), kan nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir signifikant og føre til en reduceret terapeutisk virkning af ledipasvir/sofosbuvir.
Medicinal products that are strong P-gp inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
b. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
b Patients with missing cirrhosis status were excluded from this subgroup analysis.
Famotidin doseret sammen med Harvonid
Famotidine dosed simultaneously with Harvonid
Ingen patient oplevede virologisk svigt (se pkt.
No patient experienced virologic failure (see section 4.2 for information on paediatric use).
HIV ANTIVIRALE STOFFER: INTEGRASEHÆMMERE Raltegravir (400 mg to gange dagligt)/ ledipasvir (90 mg én gang dagligt)d
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)d
• Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Sådan skal du tage Harvoni
How to take Harvoni
c. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
c Patients with missing cirrhosis status were excluded from this subgroup analysis.
Amning Du må ikke amme under behandlingen med Harvoni.
Breast-feeding Do not breast-feed during treatment with Harvoni.
Tabel 15: Recidivrater for udvalgte undergrupper i studie ION-2 LDV/SOF
Table 15: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Tacrolimus (5 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)h
Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)h
Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ ethinylestradiol 0,025 mg)/ sofosbuvir (400 mg én gang dagligt)d
Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
↑ Statiner
↑ Statins
↑ Cmin 1,48 (1,34; 1,63) Emtricitabin ↔ Cmax 1,02 (0,96; 1,08)
↑ Cmin 1.48 (1.34, 1.63) Emtricitabine ↔ Cmax 1.02 (0.96, 1.08)
Harvoni + ribavirinA i 12 uger (se pkt.
Harvoni + ribavirinA for 12 weeks (see section 5.1).
8 uger (n = 215)
8 weeks (n = 215)
Ingen dosisjustering af Harvoni eller emtricitabin/ rilpivirin/ tenofovirdisoproxilfumarat er nødvendig.
No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
H2-receptorantagonister Famotidin (40 mg enkeltdosis)/ ledipasvir (90 mg enkeltdosis)c/ sofosbuvir (400 mg enkeltdosis)c,d
H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Abacavir/ lamivudin (600 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Medianalderen var 52 år (interval 26 til 72), 82 % af patienterne var mænd, 61 % var hvide, 34 % var sorte, 75 % havde genotype 1a HCV-infektion, 2 % havde genotype 4-infektion, 76 % havde non-CC IL28B-alleller (CT eller TT), og 20 % havde kompenseret cirrose.
The median age was 52 years (range: 26 to 72); 82% of the patients were male; 61% were white; 34% were black; 75% had genotype 1a HCV infection; 2% had genotype 4 infection; 76% had non-CC IL28B alleles (CT or TT); and 20% had compensated cirrhosis.
12 uger (n = 111)
12 weeks (n = 111)
Administration af Harvoni sammen med oxcarbazepin forventes at nedsætte koncentrationen af ledipasvir og sofosbuvir og føre til en nedsat terapeutisk virkning af Harvoni.
Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Almene symptomer: Meget almindelig
General disorders: Very common fatigue
8 uger (n = 213)
8 weeks (n = 213)
c. Andet omfatter patienter, der ikke opnåede SVR og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
c Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Administration af Harvoni sammen med rifapentin forventes at nedsætte koncentrationen af ledipasvir og sofosbuvir og føre til en nedsat terapeutisk virkning af Harvoni.
Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni.
b. Andet omfatter patienter, der ikke opnåede SVR og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
b Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Rifampicin (600 mg én gang dagligt)/ sofosbuvir (400 mg enkeltdosis)d
Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
12 uger (n = 214)
12 weeks (n = 214)
Når det gives med tenofovirdisoproxilfumarat, der bruges sammen med atazanavir/ritonavir, øgede Harvoni koncentrationen af tenofovir.
When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir.
Harvoni er kontraindiceret sammen med rifabutin (se pkt.
Harvoni is contraindicated with rifabutin (see section 4.3).
Darunavir boostet med ritonavir (800 mg/ 100 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)d
Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)d
Harvoni er kontraindiceret sammen med rifampicin (se pkt.
Harvoni is contraindicated with rifampicin (see section 4.3).
I studie ION-4 indgik 13 patienter med samtidig HCV/hiv 1-infektion med genotype 1, herunder 1 patient med cirrose, hvor et regime med sofosbuvir + ribavirin havde svigtet.
In study ION-4, 13 HCV/HIV-1 co-infected patients with genotype 1, including 1 cirrhotic patient, who had failed a sofosbuvir + ribavirin regimen were enrolled; the SVR was 100% (13/13) after 12 weeks of treatment with ledipasvir/sofosbuvir.
Voksne og unge patienter 12 år eller ældre med genotype 3-CHC Patienter med kompenseret cirrose og/eller tidligere behandlingssvigt
Adult and adolescent patients 12 years of age or older with genotype 3 CHC
Hvis du har taget for meget Harvoni
If you take more Harvoni than you should
Ja a. En patient blev ekskluderet fra behandlingsarmen med 12 ugers LDV/SOF, og en patient blev ekskluderet fra behandlingsarmen med 24 ugers LDV/SOF+RBV, da begge patienter var inficeret med genotype 4 CHC.
LDV/SOF+RBV 24-week treatment arm as both patients were infected with genotype 4 CHC.
Ciclosporin (600 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)h
Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h
(Hæmning af CYP3A) Midazolam ↔ Cmax 0,95 (0,87; 1,04) ↔ AUC 0,89 (0,84; 0,95) (Induktion af CYP3A) Forventet:
(Inhibition of CYP3A) Midazolam ↔ Cmax 0.95 (0.87, 1.04)
For den samme behandlingsarm opstod der recidiv hos 4/13 (31 %) patienter med baseline-NS5A-RAVs, der gav >100 gange større ændring, sammenlignet med 3/95
For the same treatment arm, patients with baseline NS5A RAVs conferring a fold-change of > 100, relapse occurred in 4/13 (31%), as compared to 3/95 (3%) in those without any baseline RAVs or RAVs conferring a fold-change of ≤ 100.
Tabel 12: Responsrater i ION-1-studiet LDV/SOF
Table 12: Response rates in study ION-1 LDV/SOF
Tabel 14: Responsrater i studie ION-2 LDV/SOF
Table 14: Response rates in study ION-2 LDV/SOF
HIV ANTIVIRALE STOFFER: HIV PROTEASEHÆMMERE Atazanavir boostet med ritonavir (300 mg/ 100 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Når det gives med lopinavir/ritonavir, der bruges sammen med tenofovirdisoproxilfumarat, forventes Harvoni at øge koncentrationen af tenofovir.
When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Protonpumpehæmmere Omeprazol (20 mg én gang dagligt)/ ledipasvir (90 mg enkeltdosis)c/ sofosbuvir (400 mg enkeltdosis)c
Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c
Når det gives med darunavir/ritonavir, der bruges sammen med tenofovirdisoproxilfumarat, øgede Harvoni koncentrationen af tenofovir.
When given with darunavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni increased the concentration of tenofovir.
Elvitegravir/ cobicistat/ emtricitabin/ tenofovirdisoproxilfumarat (150 mg/ 150 mg/ 200 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c
Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c
b. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
b The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Ledipasvir gange↑
1.6-fold↑
Voksne med samtidig infektion med HCV/hiv - ERADICATE ERADICATE var et åbent studie til evaluering af 12 ugers behandling med ledipasvir/sofosbuvir hos 50 patienter med genotype 1 CHC med samtidig hiv-infektion.
ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
Harvoni + ribavirinA i 24 uger (se pkt.
Harvoni + ribavirinA for 24 weeks (see sections 4.4 and 5.1).
4.4) Ledipasvir/sofosbuvirs sikkerhed og virkning til behandling af non-genotype 1-infektion blev evalueret i små fase 2-studier.
Clinical efficacy and safety in genotype 2, 3, 4, 5 and 6 (see also section 4.4) Ledipasvir/sofosbuvir has been evaluated for the treatment of non-genotype 1 infection in small Phase 2 studies, as summarised below.
↑ Ledipasvir
↑ Ritonavir
Q30H/R, L31I/M/V, P32L og Y93T i genotype 1a og P58D og Y93S i genotype 1b, og substitutioner, der giver en >1.000 gange større ændring er M28A/G, Q30E/G/K, H58D, Y93C/H/N/S i genotype 1a og A92K og Y93H i genotype 1b.
Site-directed mutagenesis of NS5A RAVs showed that substitutions conferring a fold-change > 100 and ≤ 1,000 in ledipasvir susceptibility are Q30H/R, L31I/M/V, P32L and Y93T in genotype 1a and P58D and Y93S in genotype 1b; and substitutions conferring a fold-change > 1,000 are M28A/G, Q30E/G/K, H58D, Y93C/H/N/S in genotype 1a and A92K and Y93H in genotype 1b.
Efter transplantation Metavir-score F0-F3 CPT Ac
Metavir score F0-F3 95% (94/99) CPT Ac
↑ AUC 1,50 (1,42; 1,59)
↑ Cmin 1.53 (1.47, 1.59)
Harvoni er kontraindiceret sammen med carbamazepin (se pkt.
Harvoni is contraindicated with carbamazepine (see section 4.3).
LDV/SOF 24 uger (n = 109)
LDV/SOF 24 weeks (n = 109)
LDV/SOF 12 uger (n = 335)
LDV/SOF 12 weeks (n = 335)
Det skal du vide, før du begynder at tage Harvoni Sådan skal du tage Harvoni Bivirkninger
What Harvoni is and what it is used for What you need to know before you take Harvoni How to take Harvoni
HIV ANTIVIRALE STOFFER: REVERS TRANSKRIPTASEHÆMMERE Efavirenz/ emtricitabin/ tenofovirdisoproxilfumarat (600 mg/ 200 mg/ 300 mg/ én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
LDV/SOF 8 uger (n = 215)
LDV/SOF 8 weeks (n = 215)
• rifampicin og rifabutin (antibiotika, der anvendes til behandling af infektioner, herunder tuberkulose)
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression);
Abacavir ↔ Cmax 0,92 (0,87; 0,97) ↔ AUC 0,90 (0,85; 0,94)
Abacavir ↔ Cmax 0.92 (0.87, 0.97)
Den højeste dokumenterede dosis af ledipasvir og sofosbuvir var hhv. 120 mg to gange dagligt i 10 dage, og en enkeltdosis på 1.200 mg. I disse studier med raske frivillige blev der ikke dokumenteret nogen uønskede virkninger ved disse dosisniveauer, og bivirkningerne var sammenlignelige med hensyn til hyppighed og sværhedsgrad med dem, der blev rapporteret i placebogrupperne.
The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1,200 mg, respectively.
↑ Lopinavir ↑ Ritonavir
↑ Dabigatran ↔ Ledipasvir
Darunavir boostet med ritonavir (800 mg/ 100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c, d
Darunavir boosted with ritonavir (800 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
↔ AUC 1,31 (1,25; 1,36)
↔ Cmin 1.28 (1.21, 1.36)
Doseret samtidigtf
Dosed simultaneouslyf
LDV/SOF+RBV 8 uger (n = 210)
LDV/SOF+RBV 8 weeks (n = 210)
Emtricitabin/ rilpivirin/ tenofovirdisoproxilfumarat (200 mg/ 25 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c,d
Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
LDV/SOF 24 uger (n = 217)
LDV/SOF 24 weeks (n = 217)
LDV/SOF +RBV 8 uger (n = 216)
LDV/SOF+RBV 8 weeks (n = 216)
Atazanavir boostet med ritonavir (300 mg/ 100 mg én gang dagligt) + emtricitabin/ tenofovirdisoproxilfumarat (200 mg/ 300 mg én gang dagligt)/ ledipasvir (90 mg én gang dagligt)c/ sofosbuvir (400 mg én gang dagligt)c, d
Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Træthed
Relapsea
de to aktive stoffer i Harvoni, udskilles i modermælken.
It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk.
LDV/SOF 12 uger (n = 216)
LDV/SOF 12 weeks (n = 216)
Stabile replikoner NS5A transitoriske replikoner
NS5A transient replicons Median (range)a
ledipasvir (90 mg enkeltdosis)c/ sofosbuvir (400 mg enkeltdosis)c,d
Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Famotidin
Pravastating
↔ AUC 1,11 (1,02; 1,21)
↔ Cmin 1.07 (1.02, 1.13)
Stabile replikoner NS5B transitoriske replikoner
NS5B transient replicons Median (range)a
↔ AUC 1,04 (0,99; 1,08)
↔ Cmin 0.99 (0.80, 1.23)
LDV/SOF 12 uger (n = 211)
LDV/SOF 12 weeks (n = 211)
Recidiva
Otherb
↑ AUC 1,96 (1,74; 2,21)
Ledipasvir ↑ Cmax 1.98 (1.78, 2.20)
Tabel 9: Responsrater i ION-3-studiet LDV/SOV
Table 9: Response rates in study ION-3 LDV/SOF
ANTIKOAGULANTIA Dabigatranetexilat
ANTICOAGULANTS Dabigatran etexilate
↔ AUC 1,04 (1,00; 1,08)
↔ Cmin 1.08 (1.01, 1.14)
Behandlingsnaive Patienter uden cirrose Patienter med cirrose Behandlingserfarne
Treatment-naïve Patients without cirrhosis 100% (20/20) Patients with cirrhosis Treatment-experienced
LDV/SOF 12 uger (n = 214)
LDV/SOF 12 weeks (n = 214)
Cirrosed
Cirrhosisd
Svært RI (eGFR <30 ml/min/ 1,73 m2)
and <50 mL/min/1.73 m2)
Ledipasvir ↓ Cmax 0,80 (0,69: 0,93) ↔ AUC 0,89 (0,76; 1,06)
Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
↔ AUC 1,27 (1,18; 1,37)
↔ Cmin 1.18 (1.13, 1.24)
SYREREDUCERENDE STOFFER
ACID REDUCING AGENTS
Samtidig administration af lægemidler, der er stærke P-glykoprotein (P-gp)-inducere i tarmen (carbamazepin, phenobarbital, phenytoin, rifampicin, rifabutin og perikon) vil nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir signifikant og kan medføre manglende virkning af Harvoni (se pkt.
Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
I alt
Overall
Cirrose
Cirrhosis
Ciclosporin ↔ Cmax 1,06 (0,94; 1,18) ↔ AUC 0,98 (0,85; 1,14)
Ciclosporin ↔ Cmax 1.06 (0.94, 1.18)
Median (interval)a
Cmin (NA)
Tacrolimus ↓ Cmax 0,73 (0,59; 0,90) ↑ AUC 1,09 (0,84; 1,40)
Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
↔ AUC 1,35 (1,29; 1,42)
↑ Cmin 1.39 (1.29, 1.51)
↔ AUC 0,97 (0,89; 1,05)
↔ Cmin 0.98 (0.79, 1.22)
Cobicistat ↔ Cmax 1,25 (1,18; 1,32) ↑ AUC 1,59 (1,49; 1,70) ↑ Cmin 4,25 (3,47; 5,22)
↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Tabletkerne
• palpitations
• træthed
• feeling tired
GS-331007 ↔ Cmax 0,97 (0,83; 1,14) ↔ AUC 1,00 (0,87; 1,13)
GS-331007 ↔ Cmax 0.97 (0.83, 1.14)
Disse virkninger varer normalt ikke længere end 30 minutter.
These effects usually do not last longer than 30 minutes.
NO-0485 Oslo Norge
NO-0485 Oslo Norway
Regadenoson bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
Regadenoson should not be used during pregnancy unless clearly necessary.
Mere alvorlige bivirkninger omfatter:
More serious side effects include:
Dato for første markedsføringstilladelse: 06/09/2010 Dato for seneste fornyelse: 24/04/2015
Date of first authorisation: 06/09/2010 Date of latest renewal: 24/04/2015
De behøver normalt ikke at blive behandlet.
They don't usually need any treatment.
• Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
• if you are pregnant, think you are pregnant or planning to have a baby.
Dernæst tages der billeder af hjertet.
Images are then taken of the heart.
Halveringstiden for denne indledende fase er ca. 2 til 4 minutter.
The half-life of this initial phase is approximately 2 to 4 minutes.
Til måling af FFR er der gennemført fem uafhængige undersøgelser.
For the measurement of FFR, five independent studies have been conducted.
Brug af Rapiscan sammen med mad og drikke
Rapiscan with food and drink
Klassifikationsaftale Cohen's kappa
Classification agreement Cohen's kappa
Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
Not known (frequency cannot be estimated from the available data)
400 mikrogram
400 micrograms
Den injicerede dosis afhænger ikke af din vægt.
The dose injected does not depend on your weight.