natgillin/translations-raw huggingface dataset:
Table 9: Response rates in study ION-3 LDV/SOF
Preglednica 9: Stopnje odziva v študiji ION-3 LDV/SOF
≥50 and mL/min/1.
< 50 ml/min/
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
Z ritonavirjem okrepljeni atazanavir (300 mg/ 100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirat fumarat (200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/
HCV protease inhibitor + PEG-IFN+RBV
Zaviralec proteaze HCV +
No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
Pri bolnikih z dekompenzirano cirozo in/ali po presaditvi jeter, ki so prejemali ledipasvir/sofosbuvir z ribavirinom niso opazili nobenih novih neželenih učinkov zdravila.
No target organs of toxicity were identified in rat and dog studies with ledipasvir at AUC exposures approximately 7 times the human exposure at the recommended clinical dose.
V študijah ledipasvirja na podganah in psih z izpostavljenostjo AUC, ki je bila približno 7-krat večja od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso opredelili ciljnih organov za toksičnost.
LDV/SOF 24 weeks (n = 109)
LDV/SOF 24 tednov (n = 109)
No dose adjustment of Harvoni or abacavir/ lamivudine is required.
Odmerka zdravila Harvoni ali abakavirja/
Harvoni [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Harvoni [samo zunanja ovojnina]
Polyvinyl alcohol
Etinilestradiol
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.
Odrasli s sočasno okužbo HCV/HIV - ERADICATE ERADICATE je bila odprta študija, v kateri so ocenjevali 12-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem pri 50 bolnikih z okužbo CHC genotipa 1 in sočasno okužbo s HIV.
Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni.
Harvoni z rifapentinom zmanjšalo koncentracije ledipasvirja in sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Harvoni.
Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir + ribavirin ± PEG-IFN.
Pri predhodno zdravljenih bolnikih je bilo predhodno zdravljenje s PEG-IFN + ribavirinom ± zaviralcem proteaze
Genotype 6a
15b genotip 6a
The following adverse drug reactions have been identified with Harvoni (Table 6).
Pri uporabi zdravila Harvoni so ugotovili naslednje neželene učinke zdravila (preglednica 6).
Table 12: Response rates in study ION-1 LDV/SOF
Preglednica 12: Stopnje odziva v študiji ION-1 LDV/SOF
Cirrhosisd
Ciklosporin
Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Rifampicin (600 mg enkrat na dan)/ sofosbuvir
How to store Harvoni
Shranjevanje zdravila Harvoni
Co-administration with such medicinal products is not recommended with Harvoni (see section 4.4).
Sočasna uporaba teh zdravil z zdravilom Harvoni ni priporočljiva (glejte poglavje 4.4).
12 weeks (n = 217)
12 tednov (n = 217)
Harvoni is contraindicated with carbamazepine (see section 4.3).
Zdravilo Harvoni je kontraindicirano s karbamazepinom (glejte poglavje 4.3).
Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62)
Sofosbuvir ↓ Cmax 0,52 (0,43; 0,62) ↓ AUC 0,52 (0,46; 0,59)
Harvoni is contraindicated with rifabutin (see section 4.3).
Zdravilo Harvoni je kontraindicirano z rifabutinom (glejte poglavje 4.3).
Other effects that may be seen during treatment with Harvoni
Možni neželeni učinki Shranjevanje zdravila Harvoni
When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Pri sočasni uporabi z lopinavirjem/ritonavirjem v povezavi z dizoproksiltenofoviratom fumaratom se pričakuje, da zdravilo Harvoni poveča koncentracijo tenofovirja.
LDV/SOF+RBV 8 weeks (n = 216)
LDV/SOF+RBV 8 tednov (n = 216)
LDV/SOF 12 weeks (n = 335)
LDV/SOF 12 tednov (n = 335)
Impact of DAA therapy on drugs metabolized by the liver
Vpliv zdravljenja z neposredno delujočim protivirusnim zdravilom na zdravila, ki se presnavljajo v jetrih
LDV/SOF+RBV 8 weeks (n = 210)
LDV/SOF+RBV 8 tednov (n = 210)
Norelgestromin ↔ Cmax 1.02 (0.89, 1.16)
Norelgestromin ↔ Cmax 1,02 (0,89; 1,16) ↔ AUC 1,03 (0,90; 1,18)
Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
(1.000 mg pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg), če bolnik zdravilo dobro prenaša.
LDV/SOF 8 weeks (n = 215)
LDV/SOF 8 tednov (n = 215)
When given with darunavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni increased the concentration of tenofovir.
Pri sočasni uporabi z darunavirjem/ritonavirjem v povezavi z dizoproksiltenofoviratom fumaratom je zdravilo Harvoni povečalo koncentracijo tenofovirja.
The exposures to GS-331007 and ledipasvir were not altered in the presence of either meal type.
Prisotnost nobene vrste obroka ni spremenila izpostavljenosti presnovku GS-331007 in ledipasvirju.
Recommendation concerning co-administration with Harvoni
Priporočila glede sočasne uporabe z zdravilom Harvoni
Table 14: Response rates in study ION-2 LDV/SOF
Preglednica 14: Stopnje odziva v študiji ION-2 LDV/SOF
Among post-transplant patients with compensated liver disease (SOLAR-1 and SOLAR-2 studies), no relapse occurred in patients with baseline NS5A RAVs (n = 23) following 12 weeks of treatment with ledipasvir/sofosbuvir + ribavirin.
Po 12 tednih zdravljenja z ledipasvirjem/sofosbuvirjem + ribavirinom pri bolnikih s kompenzirano jetrno boleznijo po presaditvi (študiji SOLAR-1 in SOLAR-2) pri bolnikih z izhodiščnimi RAV NS5A (n = 23) ni prišlo do relapsa.
ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)d
0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/
Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
Famotidin (40 mg enkratni odmerek)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir
Reduced susceptibility to ledipasvir was associated with the primary NS5A substitution Y93H in both genotype 1a and 1b.
Zmanjšana dovzetnost za ledipasvir je bila povezana s primarno substitucijo Y93H v polimerazi
Renal impairment No dose adjustment of Harvoni is required for patients with mild or moderate renal impairment.
Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro odmerka zdravila Harvoni ni treba prilagajati.
However, the NS5B S282T substitution in combination with NS5A substitutions L31M, Y93H and Q30L were detected in one patient at failure following 8 weeks of treatment with ledipasvir/sofosbuvir from a Phase 2 study (LONESTAR).
Vendar pa so pri enem bolniku ob neuspehu po 8-tedenskem zdravljenju z ledipasvirjem/sofosbuvirjem v študiji 2. faze (LONESTAR) odkrili substitucijo S282T v polimerazi NS5B v kombinaciji s substitucijami L31M, Y93H in Q30L v polimerazi NS5A.
Harvoni is contraindicated with rifampicin (see section 4.3).
Zdravilo Harvoni je kontraindicirano z rifampicinom (glejte poglavje 4.3).
Emtricitabine ↔ Cmax 1.02 (0.98, 1.06)
Emtricitabin ↔ Cmax 0,98 (0,94; 1,02)
LDV/SOF 24 weeks (n = 217)
LDV/SOF 24 tednov (n = 217)
ANTICOAGULANTS Dabigatran etexilate
ANTIKOAGULANTI
virus.
bolnikov.
Hepatic impairment
Huda ledvična okvara
Age (years): median (range) Male gender Race: Black/ African American White Genotype 1aa IL28CC genotype FibroTest-Determined Metavir scoreb F0-F1 F2 F3-F4 Not interpretable a Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Razlaga ni mogoča a. Dva bolnika v skupini 12-tedenskega zdravljenja z LDV/SOF, en bolnik v skupini 12-tedenskega zdravljenja z LDV/SOF+RBV, dva bolnika v skupini 24-tedenskega zdravljenja z LDV/SOF in dva bolnika v skupini 24-tedenskega zdravljenja z LDV/SOF+RBV niso imeli potrjenega podtipa genotipa 1. b. Nemanjkajoči rezultati FibroTest so kartirani v rezultate Metavir glede na: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,59
Darunavir ↔ Cmax 1.01 (0.96, 1.06)
Darunavir ↔ Cmax 1,01 (0,96; 1,06) ↔ AUC 1,04 (0,99; 1,08)
Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h
Ciklosporin (600 mg enkratni odmerek)/ sofosbuvir
Darunavir ↔ Cmax 1.02 (0.88, 1.19)
↔ Cmax 1,02 (0,88; 1,19)
As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these active substances individually may occur with Harvoni.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravilo Harvoni vsebuje ledipasvir in sofosbuvir, zato se pri uporabi zdravila Harvoni lahko pojavijo katere koli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.
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.
Za priporočila o spremljanju ledvic glejte povzetke glavnih značilnosti zdravila za dizoproksiltenofovirat fumarat, emtricitabin/dizoproksiltenofovirat fumarat ali elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirat fumarat.
Dosed 1 hr Before Dialysis
1 uro pred dializo
Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone with or without other drugs that lower heart rate.
Pri uporabi zdravila Harvoni z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
↔ Cmin 1.12 (1.03, 1.21) Tenofovir ↔ Cmax 1.32 (1.25, 1.39)
↔ Cmin 1,12 (1,03; 1,21) Tenofovir
Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Harvoni z okskarbazepinom zmanjšalo koncentracije ledipasvirja in sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Harvoni.
For the combination of tenofovir/emtricitabine + darunavir/ritonavir, please see below.
darunavirja/ritonavirja glejte spodaj.
LDV/SOF 12 weeks (n = 216)
LDV/SOF 12 tednov (n = 216)
No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
rilpivirina/ dizoproksiltenofovirat fumarata ni treba prilagajati.
Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)d
Raltegravir (400 mg dvakrat na dan)/ ledipasvir (90 mg enkrat na dan)d
Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c
Omeprazol (20 mg enkrat na dan)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir
GS 331007 ↔ Cmax 1.15 (1.03, 1.27)
GS 331007 ↔ Cmax 1,15 (1,03; 1,27) ↔ AUC 1,03 (0,95; 1,12)
Do not take it before Harvoni.
Zdravila ne jemljite pred zdravilom Harvoni.
The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n=94) for 8, 12, or 24 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir Phase 2/3 trials.
ESRD, zaradi katere so potrebovali dializo, zdravljenih z ledipasvirjem/sofosbuvirjem (n = 94) 8, 12 ali 24 tednov, in primerjali s farmakokinetiko pri bolnikih brez ledvične okvare v preskušanjih 2./3.
This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment.
Ta bolnik se je nato 24 tednov ponovno zdravil z ledipasvirjem/sofosbivirjem +
Genotype 1b 0.004 Genotype 2a
Genotip 1a Genotip 1b
↑ Cmin 1.53 (1.47, 1.59)
↑ AUC 1,44 (1,41; 1,48) ↑ Cmin 1,53 (1,47; 1,59)
LDV/SOF 12 weeks (n = 211)
LDV/SOF 12 tednov (n = 211)
NS
V
Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29)
↓ Cmax 0,23 (0,19; 0,29)
LDV/SOF 12 weeks (n = 214)
LDV/SOF 12 tednov (n = 214)
CPT C
↔ AUC
GS-331007 ↔ Cmax 1.17 (1.12, 1.23)
GS-331007 ↔ Cmax 1,17 (1,12; 1,23) ↔ AUC 1,31 (1,25; 1,36)
FibroTest-Determined Metavir scoreb F0-F1
F0-F1 F2 F3-F4
↑ Cmin 1.63 (1.45, 1.84) Ritonavir ↔ Cmax 0.86 (0.79, 0.93)
↑ Cmax 1,40 (1,18; 1,66) ↔ AUC 1,20 (1,04; 1,39) ↔ Cmin 0,98 (0,79; 1,22)
↔ Cmin 1.04 (0.98, 1.11) Tenofovir ↑ Cmax 1.79 (1.56, 2.04)
↔ Cmin 1,04 (0,98; 1,11) Tenofovir
However, it is not recommended that ribavirin be increased to the originally assigned dose (1,000 mg to 1,200 mg daily).
Prilagajanje odmerka ribavirina pri odraslih, ki jemljejo 1.000-1.200 mg na dan
GS 331007 ↔ Cmax 1.04 (0.97, 1.11)
GS 331007 ↔ Cmax 1,04 (0,97; 1,11) ↔ AUC 0,99 (0,94; 1,04)
Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
Sofosbuvir ↓ Cmax 0,64 (0,53; 0,77) ↓ AUC 0,76 (0,63; 0,91)
Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
(600 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir
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
100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirat fumarat (200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/
LDV/SOF+RBV 24-week treatment arm as both patients were infected with genotype 4 CHC.
LDV/SOF+RBV sta bila izključena, ker sta bila okužena s CHC genotipa 4. b. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
Prior HCV therapy
Predhodno zdravljenje HCV
84 (3 bottles of 28) film-coated tablets.
FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet 84 (3 plastenke po 28) filmsko obloženih tablet
When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
emtricitabinom/ dizoproksiltenofovirat fumaratom se pričakuje, da bo zdravilo Harvoni povečalo koncentracijo tenofovirja.
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
Z ritonavirjem okrepljeni atazanavir (300 mg/ 100 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir
GS-331007 ↔ Cmax 1.00 (0.94, 1.07)
GS-331007 ↔ Cmax 1,00 (0,94; 1,07) ↔ AUC 1,05 (1,01; 1,09)
↑ Cmin 1.59 (1.49, 1.70) Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
↑ Cmax 1,64 (1,54; 1,74) ↑ AUC 1,50 (1,42; 1,59) ↑ Cmin 1,59 (1,49; 1,70)
Male
Odmerjeno
↔ Cmin 1.07 (0.89, 1.28) Norgestrel ↔ Cmax 1.18 (0.99, 1.41)
Norgestrel ↔ Cmax 1,03 (0,87; 1,23) ↔ AUC 0,99 (0,82; 1,20)
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
Elvitegravir/ kobicistat/emtricitabin/ dizoproksiltenofovirat fumarat (150 mg/ 150 mg/ 200 mg/
Package leaflet: Information for the user Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir This medicine is subject to additional monitoring.
Navodilo za uporabo Harvoni 90 mg/400 mg filmsko obložene tablete ledipasvir/sofosbuvir
Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42)
↔ Cmax 1,12 (0,88; 1,42)
↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Ledipasvir ↔ Cmax 1,10 (1,01; 1,19)
↑ Digoxin ↔ Ledipasvir
Abakavir/ lamivudin
SVR Outcome for patients without SVR On-treatment virologic failure Relapsea Otherb SVR rates for selected subgroups Genotype Genotype 1a Genotype 1b Cirrhosis No
Stabilni replikoni prehodni replikoni NS5B mediana (razpon)a genotip 1a genotip 1b genotip 2a genotip 2b
Titanium dioxide
Norgestimat/ etinilestradiol
Excipients
Emtricitabin
Atazanavir ↔ Cmax 1.07 (0.99, 1.14)
Ledipasvir ↔ Cmax 1,11 (0,99; 1,24)
↔ Cmin 0.91 (0.83, 0.99) Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
↓ Cmax 0,83 (0,69; 1,00) ↔ AUC 0,98 (0,80; 1,20)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI
Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)h
sofosbuvir (400 mg enkratni odmerek)h
↔ Cmin 1.08 (0.98, 1.20) Ritonavir ↔ Cmax 1.17 (1.01, 1.35)
↔ Cmin 1,08 (0,98; 1,20) Ritonavir
GS-331007 ↑ Cmax 1.33 (1.22, 1.44)
↑ Cmax 1,33 (1,22; 1,44)
Skin and subcutaneous tissue disorders: Common rash
Bolezni kože in podkožja:
↔ Cmin 1.07 (1.02, 1.13)
↔ Cmax 1,14 (1,01; 1,29)
STATEMENT OF ACTIVE SUBSTANCE(S)
(vzdrževalna terapija z metadonom [30 do
Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ sofosbuvir (400 mg once daily)
(800 mg/ 100 mg enkrat na dan)/ sofosbuvir (400 mg enkrat na dan)
Ledipasvir ↓ Cmax 0.89 (0.61, 1.30)
↓ Cmax 0,89 (0,61; 1,30) ↓ AUC 0,96 (0,66; 1,39)
Treatment-naïve Patients without cirrhosis 100% (20/20) Patients with cirrhosis Treatment-experienced
Predhodno nezdravljeni Bolniki brez ciroze Bolniki s cirozo Predhodno zdravljeni
used to treat HIV infection;
PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI PROTEAZE HIV
Ledipasvir ↓ Cmax 0.65 (0.56, 0.76)
↓ Cmax 0,66 (0,59; 0,75) ↓ AUC 0,66 (0,59; 0,75) ↓ Cmin 0,66 (0,57; 0,76)
GS-331007 ↔ Cmax 1.06 (1.01, 1.11)
GS-331007 ↔ Cmax 1,06 (1,01; 1,11) ↔ AUC 1,15 (1,11; 1,19)
Moderate RI
Zmerna ledvična okvara
Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
↓ Cmax 0,80 (0,69; 0,93) ↔ AUC 0,89 (0,76; 1,06)
↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
↔ Cmax 1,02 (0,98; 1,06) ↔ AUC 1,05 (1,02; 1,08) ↔ Cmin 1,06 (0,97; 1,15)
GS-331007 ↔ Cmax 0.97 (0.83, 1.14)
GS-331007 ↓ Cmax 0,73 (0,65; 0,83) ↔ AUC 1,04 (0,89; 1,22)
↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
↔ Cmax 1,25 (1,18; 1,32) ↑ AUC 1,59 (1,49; 1,70) ↑ Cmin 4,25 (3,47; 5,22)
Abacavir ↔ Cmax 0.92 (0.87, 0.97)
↔ Cmax 0,92 (0,87; 0,97) ↔ AUC 0,90 (0,85; 0,94)
↑ Cmin 1.91 (1.74, 2.10) Ledipasvir ↔ Cmax 1.01 (0.95, 1.07)
↑ Cmax 1,68 (1,54; 1,84) ↑ AUC 1,96 (1,74; 2,21) ↑ Cmin 2,18 (1,91; 2,50)
No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required.
Odmerka zdravila Harvoni ali emtricitabina/
↔ Cmin 1.28 (1.21, 1.36)
↔ Cmax 1,23 (1,14; 1,34)
FCH
PC
↑ Ritonavir
Jetrna okvara
↑ Cmin 1.47 (1.38, 1.57) Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
↑ Cmax 1,47 (1,37; 1,58) ↔ AUC 1,35 (1,29; 1,42) ↑ Cmin 1,47 (1,38; 1,57)
Cirrhosis
Cirozad
↔ Cmin 0.95 (0.74, 1.22) Sofosbuvir ↓ Cmax 0.95 (0.68, 1.33)
↔ Cmax 0,95 (0,87; 1,04) ↔ AUC 0,89 (0,84; 0,95) (indukcija CYP3A)
LDV/SOF+RBV 24 weeks (n = 307)a,b
LDV/SOF+RBV 24 tednov (n = 111)
↓ Cmin 0.66 (0.57, 0.76) Sofosbuvir ↔ Cmax 1.03 (0.87, 1.23)
↓ Cmax 0,65 (0,56; 0,76) ↓ AUC 0,41 (0,36; 0,48)
These measures will help to protect the environment .
Taki ukrepi pomagajo varovati okolje.
These effects usually do not last longer than 30 minutes.
Ti učinki običajno ne trajajo dlje kot 30 minut.
Date of first authorisation: 06/09/2010 Date of latest renewal: 24/04/2015
Datum prve odobritve: 06/09/2010 Datum zadnjega podaljšanja: 24/04/2015
Not known (frequency cannot be estimated from the available data)
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
• if you are pregnant, think you are pregnant or planning to have a baby.
• če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
They don't usually need any treatment.
Običajno jih ni treba zdraviti.
Adverse reactions occurred in approximately 80% of patients.
Neželeni učinki so se pojavili pri približno 80% bolnikov.
The half-life of this initial phase is approximately 2 to 4 minutes.
Razpolovna doba te začetne faze je približno 2 do 4 minute.
More serious side effects include:
Resnejši neželeni učinki vključujejo:
For the measurement of FFR, five independent studies have been conducted.
Za merjenje FFR so izvedli pet neodvisnih študij.
The data are insufficient to conclude about the risk of interactions at the level of these transporters given that a single concentration was evaluated in most instances.
Toda podatkov ni dovolj, da bi se lahko sklepalo o tveganju za interakcije na ravni teh prenašalcev, glede na to, da so v večini primerov ocenjevali samo eno kocentracijo.
Effect of caffeine
Učinek kofeina
Tell your doctor straight away if you think you are having severe side effects.
Zdravniku takoj povejte, če menite, da imate hude neželene učinke.
However, given the proposed duration of use, the effects of the drug transporters are unlikely to be clinically relevant.
Vendar pa zaradi predlaganega trajanja uporabe učinki prenašalcev zdravil verjetno ne bodo klinično pomembni.
• ringing in the ears
• zvonjenje v ušesih
Patients initiated exercise using a standard or modified Bruce protocol.
Bolniki so začeli s telesno vadbo z uporabo standardnega ali modificiranega Bruce-ovega protokola.
The doctor, nurse or medical technician will let you know when you can stand up.
Zdravnik, medicinska sestra ali medicinski tehnik vam bo povedal/-a, kdaj lahko vstanete.
The median time between scans was 7 days (range of 1-104 days).
Mediani čas med slikanji je bil 7 dni (razpon 1-104 dni).
Regadenoson should not be used during pregnancy unless clearly necessary.
Regadenozona ne smete uporabljati pri nosečnicah, razen če je to jasno potrebno.
Stolker et al. 2015 (n=149) van Nunen et al. 2015 (n=98)
Stolker in sodelavci 2015 (n=194) van Nunen in sodelavci 2015 (n = 98)
Dyspnoea did not correlate with a decrease in FEV1.
Dispneja ni korelirala z zmanjšanjem FEV1.
Distribution Regadenoson is moderately bound to human plasma proteins (25-30%).
Porazdelitev Regadenozon se zmerno veže na beljakovine človeške plazme (25-30%).
C-radiolabeled regadenoson to rats and dogs, most radioactivity (85-96%) was excreted in the form of unchanged regadenoson.
C-označenega regadenozona podganam in psom se je večina radioaktivnosti (85-96%) izločila v obliki nespremenjenega regadenozona.
• changes in heart tracing tests (electrocardiogram)
• spremembe preiskav sledenja srca (elektrokardiogram)
Children and adolescents Rapiscan should not be used in children and adolescents below the age of 18 years.
Otroci in mladostniki Zdravilo Rapiscan se ne sme uporabljati pri otrocih in mladostnikih, starih manj kot 18 let.
Do not drive or operate machinery until these effects have improved.
Ne vozite avtomobila in ne upravljajte s stroji, dokler ti učinki ne izzvenijo.
Adenosine was treated as a gold standard to estimate sensitivity, specificity, and the proportion of accuracy.
Adenozin je predstavljal zlati standard za oceno občutljivosti, specifičnosti in razmerja natančnosti.
If any of these apply to you, tell your doctor before you are given the injection.
Če kar koli od naštetega velja za vas, to povejte zdravniku, preden vam da injekcijo.
Rate Difference (regadenoson - Adenosine) (± 95% Confidence Interval
Stopnja razlike (regadenozon - adenozin) (± SE) 95% interval zaupanja
• excessive sweating
• pretirano znojenje
Harmful effects have been seen in animal studies but it is not known if there is a risk to humans.
Pri študijah na živalih so opazili škodljive učinke, vendar tveganja za človeka niso znana.
They normally start soon after the Rapiscan injection and are usually over within 30 minutes.
Običajno se začnejo kmalu po injiciranju zdravila Rapiscan in običajno izzvenijo v 30 minutah.
The side effects are usually mild.
Neželeni učinki so običajno blagi.
During the exercise, a small amount of radiopharmaceutical is injected into the body, often into a vein in the hand.
Med vadbo se v telo vbrizga majhna količina radiofarmacevtskega izdelka, pogosto v veno na roki.
Most increases resolved within 10 to 15 minutes, but in some cases, increases were observed at 45 minutes following administration.
Povišanja so večinoma izginila v 10 do 15 minutah, vendar so v nekaterih primerih opazili povišanje 45 minut po uporabi zdravila.
• if you have asthma or lung disease.
• ali imate astmo ali bolezen pljuč.
This leaflet was last revised in MM/YYYY
Navodilo je bilo nazadnje revidirano dne MM/LLLL
Images are then taken of the heart.
Zatem se naredijo posnetki srca.