natgillin/translations-raw huggingface dataset:
Harvoni is contraindicated with rifampicin (see section 4.3).
Harvoni je kontraindiciran s rifampicinom (vidjeti dio 4.3).
Cirrhosisd
Ciklosporing
LDV/SOF 12 weeks (n = 335)
LDV/SOF 12 tjedana (n = 335)
LDV/SOF 24 weeks (n = 109)
LDV/SOF 24 tjedna (n = 109)
LDV/SOF+RBV 8 weeks (n = 216)
LDV/SOF+RBV 8 tjedana (n = 216)
Patients with renal impairment
Bolesnici bez ciroze
When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Kad se daje s lopinavirom/ritonavirom koji se primjenjivao zajedno s tenofovirdizoproksilfumaratom, očekuje se da će Harvoni povećati koncentraciju tenofovira.
LDV/SOF+RBV 8 weeks (n = 210)
LDV/SOF+RBV 8 tjedana (n = 210)
Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni.
Očekuje se da će istovremena primjena lijeka Harvoni s rifapentinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
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/ tenofovirdizoproksilfumarat (150 mg/ 150 mg/ 200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c
Genotype 1b
Genotip 1a Genotip 1b
Table 14: Response rates in study ION-2 LDV/SOF
Tablica 14: Stope odgovora u ispitivanju ION-2 LDV/SOF
LDV/SOF 8 weeks (n = 215)
LDV/SOF 8 tjedana (n = 215)
Severe RI (eGFR
Teško oštećenje bubrega (eGFR
When given with darunavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni increased the concentration of tenofovir.
Kad se daje s darunavirom/ritonavirom koji se primjenjivao zajedno s tenofovirdizoproksilfumaratom, Harvoni će povećati koncentraciju tenofovira.
Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)h
Ciklosporin (jedna doza od 600 mg)/ sofosbuvir (jedna doza od 400 mg)h
LDV/SOF 24 weeks (n = 217)
LDV/SOF 24 tjedna (n = 217)
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
Darunavir pojačan ritonavirom (800 mg/ 100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
Concerning recommended regimens with different HCV genotypes, see section 4.2.
Za preporučene režime kod različitih genotipova HCV-a, vidjeti dio 4.2. Za virološko i kliničko djelovanje na određeni genotip, vidjeti dio 5.1.
Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Očekuje se da će istovremena primjena lijeka Harvoni s okskarbazepinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
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 istovremeno zaraženi HCV/HIV-om - ERADICATE ERADICATE je bilo otvoreno ispitivanje kojim se procijenilo 12 tjedana liječenja ledipasvirom/sofosbuvirom u 50 bolesnika s CHC-om uzrokovanim genotipom 1 i istovremenom HIV-infekcijom.
Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c, d
(jedna doza od 40 mg)/ ledipasvir (jedna doza od 90 mg)c/ sofosbuvir (jedna doza od 400 mg)c, d
IMMUNOSUPPRESSANTS Ciclosporing
Inhibitori protonske pumpe
Abacavir ↔ Cmax 0.92 (0.87, 0.97)
Abakavir ↔ Cmax 0,92 (0,87; 0,97) ↔ AUC 0,90 (0,85; 0,94)
↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir
↔ Dolutegravir ↔ Ledipasvir ↔ Sofosbuvir ↔ GS-331007
Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50)
Sofosbuvir ↑ Cmax 1,15 (0,88; 1,50) ↔ AUC 1,11 (1,00; 1,24)
Vitamin K antagonists
Antagonisti vitamina
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
Emtricitabin/ rilpivirin/ tenofovirdizoproksilfumarat (200 mg/ 25 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)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
Atazanavir pojačan ritonavirom (300 mg/ 100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
LDV/SOF 12 weeks (n = 216)
LDV/SOF 12 tjedana (n = 216)
Genotype
Genotip
• light-headedness
• ošamućenost
Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62)
Sofosbuvir ↓ Cmax 0,52 (0,43; 0,62) ↓ AUC 0,52 (0,46; 0,59) Cmin (NA)
Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c
Omeprazol (20 mg jedanput na dan)/ ledipasvir (jedna doza od 90 mg)c/ sofosbuvir (jedna doza od 400 mg)c
Close monitoring of INR is recommended with all vitamin K antagonists.
Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja lijekom Harvoni.
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment.
Nakon uvođenja liječenja direktno djelujućim antivirusnim lijekovima, bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
Table 6: Adverse drug reactions identified with Harvoni Frequency
Tablica 6: Nuspojave utvrđene uz Harvoni
Ledipasvir ↓ Cmax 0.89 (0.61, 1.30)
Ledipasvir ↓ Cmax 0,89 (0,61; 1,30) ↓ AUC 0,96 (0,66; 1,39)
↑ Pravastatin
Nuspojava
CC
K
Other effects that may be seen during treatment with Harvoni
Mogućnost utjecaja drugih lijekova na Harvoni
GS-331007 ↑ Cmax 1.33 (1.22, 1.44)
GS-331007 ↑ Cmax 1,33 (1,22; 1,44) ↑ AUC 1,44 (1,41; 1,48) ↑ Cmin 1,53 (1,47; 1,59)
LDV/SOF 12 weeks (n = 211)
LDV/SOF 12 tjedana (n = 211)
Demographics and baseline characteristics were balanced across the two treatment groups.
Dvije terapijske skupine bile su slične po demografskim i početnim značajkama.
GS-331007 ↔ Cmax 1.09 (0.99, 1.19)
GS-331007 ↔ Cmax 1,09 (0,99; 1,19) ↔ AUC 1,02 (0,97; 1,08)
a One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon-based regimen.
Prethodno liječenje režimom na temelju nepegiliranog interferona bilo je neuspješno u jednog bolesnika u terapijskoj skupini liječenoj 24 tjedna LDV/SOF-om i jednog bolesnika u skupini liječenoj 24 tjedna LDV/SOF+RBV-om.
FibroTest-Determined Metavir scoreb F0-F1
Metavir-rezultat određen FibroTestomb
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.
U dva bolesnika u terapijskoj skupini liječenoj 12 tjedana LDV/SOF-om, jednog bolesnika u skupini liječenoj 12 tjedana LDV/SOF + RBV-om, dva bolesnika u terapijskoj skupini liječenoj 24 tjedna LDV/SOF-om i dva bolesnika u terapijskoj skupini liječenoj 24 tjedna LDV/SOF+RBV-om nije bila potvrđena podvrsta genotipa 1. b. Rezultati FibroTesta koji nisu nedostajali bili su mapirani na Metavir-rezultate prema sljedećem: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,59-1,00 = F3-F4.
Harvoni is contraindicated with St. John's wort (see section 4.3).
Harvoni je kontraindiciran s gospinom travom (vidjeti dio 4.3).
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) Cmin (NA)
• headache
• glavobolja • umor
LDV/SOF 12 weeks (n = 214)
LDV/SOF 12 tjedana (n = 214)
Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43)
Sofosbuvir ↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57)
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)d
Raltegravir (400 mg dvaput na dan)/ ledipasvir (90 mg jedanput na dan)d
Of the 100 treated patients, the median age was 15 years (range: 12 to 17); 63% of the patients were female; 90% were White, 7% were Black, and 2% were Asian; 13% were Hispanic/Latino; mean weight was 61.3 kg (range: 33.0 to 126.0 kg); 55% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 81% had genotype 1a HCV infection; 76% had non-CC IL28B alleles (CT or TT) and 1% had known cirrhosis.
U 100 liječenih bolesnika medijan dobi bio je 15 godina (raspon: od 12 do 17); 63 % bolesnika bilo je ženskog spola; 90 % bolesnika bili su bijelci, 7 % crnci, a 2 % Azijci; 13 % bili su Hispano/Latinoamerikanci; srednja vrijednost tjelesne težine iznosila je 61,3 kg (raspon: od 33,0 do
↑ Cmin 1.63 (1.45, 1.84) Ritonavir ↔ Cmax 0.86 (0.79, 0.93)
Etinilestradiol ↑ Cmax 1,40 (1,18; 1,66) ↔ AUC 1,20 (1,04; 1,39) ↔ Cmin 0,98 (0,79; 1,22)
↑ Cmin 1.39 (1.29, 1.51)
Ledipasvir ↑ Cmax 1,45 (1,34; 1,56) ↑ AUC 1,39 (1,28; 1,49) ↑ Cmin 1,39 (1,29; 1,51)
Fertility
Nizatidine
ACID REDUCING AGENTS
LIJEKOVI KOJI SMANJUJU KISELOST
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) Cmin (NA)
Tel: + 420 910 871 986
Česká republika Gilead Sciences s.r.o. Tel: + 420 910 871 986
↑ Cmin 1.91 (1.76, 2.08) Sofosbuvir ↑ Cmax 1.33 (1.14, 1.56)
Sofosbuvir ↑ Cmax 1,33 (1,14; 1,56) ↑ AUC 1,36 (1,21; 1,52)
Norelgestromin ↔ Cmax 1.07 (0.94, 1.22)
Norelgestromin ↔ Cmax 1,07 (0,94; 1,22) ↔ AUC 1,06 (0,92; 1,21) ↔ Cmin 1,07 (0,89; 1,28)
GS-331007 ↓ Cmax 0.73 (0.65, 0.83)
GS-331007 ↓ Cmax 0,73 (0,65; 0,83) ↔ AUC 1,04 (0,89; 1,22)
GS-331007 ↓ Cmax 0.60 (0.53, 0.69)
GS-331007 ↓ Cmax 0,60 (0,53; 0,69) ↔ AUC 1,04 (0,90; 1,20)
Ledipasvir ↓ Cmax 0.80 (0.69, 0.93)
Ledipasvir ↓ Cmax 0,80 (0,69; 0,93) ↔ AUC 0,89 (0,76; 1,06)
GS-331007 ↔ Cmax 1.13 (1.07, 1.20)
GS-331007 ↔ Cmax 1,13 (1,07; 1,20) ↔ AUC 1,06 (1,01; 1,12)
Ledipasvir ↓ Cmax 0.83 (0.69, 1.00)
Ledipasvir ↓ Cmax 0,83 (0,69; 1,00) ↔ AUC 0,98 (0,80; 1,20)
HCV protease inhibitor (ION-2).
HIV ANTIVIRUSNI LIJEKOVI: INHIBITORI PROTEAZE HIV-A
Outcome for patients without SVR On-treatment virologic failure Relapseb Otherc SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12.
U ispitivanje je bilo uključeno 8 bolesnika s infekcijom HCV-om genotipa 4; 8/8 ih je postiglo SVR12. b. Nazivnik za relaps je broj bolesnika s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja terapije.
Ledipasvir ↓ Cmax 0.65 (0.56, 0.76)
Ledipasvir ↓ Cmax 0,66 (0,59; 0,75) ↓ AUC 0,66 (0,59; 0,75) ↓ Cmin 0,66 (0,57; 0,76)
↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, 1.13)
↔ Cmax 0,95 (0,79; 1,13) ↔ AUC 0,95 (0,77; 1,17) ↔ Cmin 0,95 (0,74; 1,22)
↔ Cmin 1.04 (0.98, 1.11) Tenofovir ↑ Cmax 1.79 (1.56, 2.04)
Tenofovir ↑ Cmax 1,79 (1,56; 2,04) ↑ AUC 1,98 (1,77; 2,23) ↑ Cmin 2,63 (2,32; 2,97)
GS-331007 ↔ Cmax 0.97 (0.83, 1.14)
GS-331007 ↔ Cmax 0,97 (0,83; 1,14) ↔ AUC 1,00 (0,87; 1,13)
Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42)
Sofosbuvir ↔ Cmax 1,12 (0,88; 1,42) ↔ AUC 1,00 (0,80; 1,25)
Norelgestromin ↔ Cmax 1.02 (0.89, 1.16)
Norelgestromin ↔ Cmax 1,02 (0,89; 1,16) ↔ AUC 1,03 (0,90; 1,18) ↔ Cmin 1,09 (0,91; 1,31)
GS-331007 ↔ Cmax 1.06 (0.97, 1.14)
GS-331007 ↔ Cmax 1,06 (0,97; 1,14) ↔ AUC 1,06 (1,02; 1,11)
Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
Sofosbuvir ↓ Cmax 0,63 (0,52; 0,75) ↓ AUC 0,73 (0,65; 0,82)
GS-331007 ↔ Cmax 0.97 (0.90, 1.05)
GS-331007 ↔ Cmax 0,97 (0,90; 1,05) ↔ AUC 1,24 (1,18; 1,30)
↔ Cmin 1.12 (1.03, 1.21) Tenofovir ↔ Cmax 1.32 (1.25, 1.39)
Tenofovir ↔ Cmax 1,32 (1,25; 1,39) ↑ AUC 1,40 (1,31; 1,50) ↑ Cmin 1,91 (1,74; 2,10)
↑ Cmin 1.59 (1.49, 1.70) Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Tenofovir ↑ Cmax 1,64 (1,54; 1,74) ↑ AUC 1,50 (1,42; 1,59) ↑ Cmin 1,59 (1,49; 1,70)
↔ Cmin 0.97 (0.86, 1.10) Ledipasvir ↑ Cmax 1.45 (1.34, 1.56)
Sofosbuvir ↑ Cmax 1,45 (1,10; 1,92) ↑ AUC 1,34 (1,12; 1,59)
Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
Sofosbuvir ↓ Cmax 0,64 (0,53; 0,77) ↓ AUC 0,76 (0,63; 0,91) Cmin (NA)
↔ 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) ↔ Cmin 1,00 (0,81; 1,23)
Not interpretable a One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype.
U jednog bolesnika u terapijskoj skupini liječenoj 8 tjedana LDV/SOF-om nije bila potvrđena podvrsta genotipa 1. b. Rezultati FibroTesta koji nisu nedostajali bili su mapirani na Metavir-rezultate prema sljedećem: 0-0,31 = F0-F1;
EXP
Ostaloc
↔ Cmin 1.16 (1.08, 1.25) Sofosbuvir ↔ Cmax 1.05 (0.93, 1.20)
Sofosbuvir ↔ Cmax 1,08 (0,85; 1,35) ↔ AUC 1,21 (1,09; 1,35)
↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Sofosbuvir ↔ Cmax 1,05 (0,93; 1,20) ↔ AUC 1,10 (1,01; 1,21)
Ciclosporin ↔ Cmax 1.06 (0.94, 1.18)
Ciklosporin ↔ Cmax 1,06 (0,94; 1,18) ↔ AUC 0,98 (0,85; 1,14)
↔ Cmin 0.91 (0.83, 0.99) Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Emtricitabin ↔ Cmax 1,02 (0,96; 1,08) ↔ AUC 1,04 (1,00; 1,08) ↔ Cmin 1,03 (0,97; 1,10)
(Inhibition of CYP3A) Midazolam ↔ Cmax 0.95 (0.87, 1.04)
Midazolam ↔ Cmax 0,95 (0,87; 1,04) ↔ AUC 0,89 (0,84; 0,95) (Indukcija CYP3A)
↑ Cmin 2.18 (1.91, 2.50) Sofosbuvir ↔ Cmax 1.01 (0.88, 1.15)
Sofosbuvir ↔ Cmax 1,01 (0,88; 1,15) ↔ AUC 1,11 (1,02; 1,21)
f Staggered administration (12 hours apart) of atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate or darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate and Harvoni provided similar results.
+ emtricitabin/tenofovirdizoproksilfumarata ili darunavira/ritonavira
↔ Cmin 0.95 (0.81, 1.12) Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08)
Sofosbuvir ↔ Cmax 0,96 (0,88; 1,05) ↔ AUC 1,08 (1,02; 1,15)
↔ Cmin 1.08 (0.98, 1.20) Ritonavir ↔ Cmax 1.17 (1.01, 1.35)
Ledipasvir ↔ Cmax 1,01 (0,95; 1,07) ↔ AUC 1,08 (1,02; 1,15) ↔ Cmin 1,16 (1,08; 1,25)
↔ Cmin 1.26 (1.17, 1.36) Sofosbuvir ↔ Cmax 1.08 (0.85, 1.35)
Sofosbuvir ↔ Cmax 1,00 (0,76; 1,32) ↔ AUC 0,95 (0,82; 1,10)
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
Efavirenz/ emtricitabin/ tenofovirdizoproksilfumarat (600 mg/ 200 mg/ 300 mg/ jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
Emtricitabin ↔ Cmax 1,02 (0,98; 1,06) ↔ AUC 1,05 (1,02; 1,08) ↔ Cmin 1,06 (0,97; 1,15)
Copovidone
Okskarbazepin
↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Kobicistat ↔ Cmax 1,25 (1,18; 1,32) ↑ AUC 1,59 (1,49; 1,70) ↑ Cmin 4,25 (3,47; 5,22)
GS-331007 ↔ Cmax 1.23 (1.14, 1.34)
GS-331007 ↔ Cmax 1,23 (1,14; 1,34) ↔ AUC 0,95 (0,88; 1,03)
↑ Cmin 1.15 (0.90, 1.46) Ledipasvir ↔ Cmax 0.92 (0.85, 1.00)
Raltegravir ↓ Cmax 0,82 (0,66; 1,02) ↔ AUC 0,85 (0,70; 1,02) ↑ Cmin 1,15 (0,90; 1,46)
Excipients
Pravastatin
Darunavir ↔ Cmax 0.97 (0.94, 1.01)
Darunavir ↔ Cmax 0,97 (0,94; 1,01) ↔ AUC 0,97 (0,94; 1,00) ↔ Cmin 0,86 (0,78; 0,96)
Ledipasvir ↑ Cmax 1.98 (1.78, 2.20)
Ledipasvir ↑ Cmax 1,98 (1,78; 2,20) ↑ AUC 2,13 (1,89; 2,40) ↑ Cmin 2,36 (2,08; 2,67)
↑ Cmin 1.48 (1.34, 1.63) Emtricitabine ↔ Cmax 1.02 (0.96, 1.08)
Emtricitabin ↔ Cmax 0,98 (0,94; 1,02) ↔ AUC 1,00 (0,97; 1,04) ↔ Cmin 1,04 (0,96; 1,12)
↔ Cmin 0.95 (0.74, 1.22) Sofosbuvir ↓ Cmax 0.95 (0.68, 1.33)
Sofosbuvir ↔ Cmax 0,87 (0,71; 1,08) ↔ AUC 0,95 (0,82; 1,09)
These effects usually do not last longer than 30 minutes.
Ovi učinci obično ne traju duže od 30 minuta.
• if you are pregnant, think you are pregnant or planning to have a baby.
• ako ste trudni, mislite da biste mogli biti trudni ili planirate imate dijete.
Rapiscan with food and drink
Rapiscan s hranom i pićem
They don't usually need any treatment.
Obično ne zahtijevaju liječenje.
400 micrograms
400 mikrograma
The half-life of this initial phase is approximately 2 to 4 minutes.
Poluvijek ove inicijalne faze iznosi oko 2 do 4 minute.
Regadenoson should not be used during pregnancy unless clearly necessary.
Regadenoson se ne bi smio primjenjivati tijekom trudnoće osim ako to nije izričito potrebno.
Harmful effects have been seen in animal studies but it is not known if there is a risk to humans.
Primijećeni su štetni učinci u ispitivanjima na životinjama, ali nije poznato postoji li rizik za ljude.
NO-0485 Oslo Norway
NO-0485 Oslo Norveška
Classification agreement Cohen's kappa
Klasifikacijsko slaganje Cohen's kappa
The doctor, nurse or medical technician will let you know when you can stand up.
Liječnik, medicinska sestra ili medicinski tehničar reći će Vam kad smijete ustati.
For the measurement of FFR, five independent studies have been conducted.
Za mjerenje FFR-a provedeno je pet neovisnih studija.
Patients initiated exercise using a standard or modified Bruce protocol.
Bolesnici su započeli vježbu primjenom standardnog ili modificiranog Bruce-ovog protokola.
Stolker et al. 2015 (n=149) van Nunen et al. 2015 (n=98)
Stolker i sur., 2015 (n=149) van Nunen i sur., 2015 (n=98)
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.
Podaci nisu dovoljni za donošenje zaključka o riziku interakcija na razini tih transportera s obzirom da je u većini slučajeva procijenjena jedna koncentracija.
Multiple injections
Višestruke injekcije
Tell your doctor straight away if you think you are having severe side effects.
Odmah recite svom liječniku ako mislite da imate teške nuspojave.
Effect of caffeine
Učinak kofeina
These measures will help to protect the environment .
Ove će mjere pomoći u očuvanju okoliša.
This is because caffeine can interfere with the effect of Rapiscan.
To je zato što kofein može interferirati s učinkom Rapiscana.
Particular care should be taken with the following medicines:
Posebno treba biti oprezan kod uzimanja sljedećih lijekova:
Do not eat food or have drinks containing caffeine (for example, tea, coffee, cocoa, cola or chocolate) for at least 12 hours before you are given Rapiscan.
Nemojte jesti hranu ili piti pića koja sadrže kofein (primjerice čaj, kavu, kakao, kolu ili čokoladu) najmanje 12 sati prije nego primite Rapiscan.
The median time between scans was 7 days (range of 1-104 days).
Medijan vremena između dva snimanja bila je 7 dana (raspon 1-104 dana).
Images are then taken of the heart.
Potom se slika srce.
Children and adolescents Rapiscan should not be used in children and adolescents below the age of 18 years.
Rapiscan se ne bi smio koristiti u djece i adolescenata mlađih od 18 godina.
If you are given more Rapiscan than you should
Ako primite više Rapiscana nego što ste trebali
However, given the proposed duration of use, the effects of the drug transporters are unlikely to be clinically relevant.
Međutim, s obzirom na preporučeno trajanje primjene, učinci transportera lijeka vjerojatno neće biti klinički relevantni.
This leaflet was last revised in MM/YYYY
Ova uputa je zadnji puta revidirana u MM/GGGG
Sensitivity Specificity
Osjetljivost Specifičnost
Safety and tolerability testing
Testiranje sigurnosti i podnošljivosti
Hyperaemia may fluctuate between sub-maximum and maximum until it slowly vanishes.
Hiperemija može fluktuirati između submaksimalne i maksimalne dok polako ne nestane.
However, the maximum observed plasma concentrations as well as volumes of distribution estimates were similar across the groups.
Ipak, zabilježena maksimalna koncentracija u plazmi kao i procjene volumena distribucije bili su slični u svim skupinama.
What Rapiscan is and what it is used for
Što je Rapiscan i za što se koristi
PACKAGE LEAFLET: INFORMATION FOR THE USER
Uputa o lijeku: Informacije za korisnika
They normally start soon after the Rapiscan injection and are usually over within 30 minutes.
Obično se javljaju odmah nakon injekcije Rapiscana i obično prolaze unutar 30 minuta.
Other medicines and Rapiscan
Drugi lijekovi i Rapiscan
Adverse reactions occurred in approximately 80% of patients.
Nuspojave su se javljale u oko 80% bolesnika.
The dose injected does not depend on your weight.
Injicirana doza ne ovisi o Vašoj tjelesnoj težini.
Dyspnoea did not correlate with a decrease in FEV1.
Dispneja nije korelirala sa smanjenjem FEV1.
Adenosine was treated as a gold standard to estimate sensitivity, specificity, and the proportion of accuracy.
Adenozin je uzet kao zlatni standard kako bi se procijenila osjetljivost, specifičnost i omjer točnosti.
If any of these apply to you, tell your doctor before you are given the injection.
Ako se bilo što od navedenog odnosi na Vas, recite to svom liječniku prije nego primite injekciju.
The side effects are usually mild.
Nuspojave su obično blage.
Do not drive or operate machinery until these effects have improved.
Nemojte voziti, rukovati alatima niti strojevima dok ovi učinci ne prođu.
Your doctor will only give you Rapiscan if it is clearly necessary.
Vaš će Vam liječnik dati Rapiscan samo ako je to neophodno.
Distribution Regadenoson is moderately bound to human plasma proteins (25-30%).
Distribucija Regadenoson se umjereno veže na proteine plazme u ljudi (25-30%).
• if you have low blood pressure (hypotension).
- ako imate niski krvni tlak (hipotenziju).
This belongs to a group of medicines called ‘coronary vasodilators'.
Pripada skupini lijekova koji se nazivaju "koronarni vazodilatatori".
Bronchoconstriction
Bronhokonstrikcija
Respiratory effects
Respiratorni učinci
The terminal phase consists of a decline in plasma concentration with a half-life of approximately 2 hours.
Terminalna faza sastoji se od pada koncentracije u plazmi s poluvijekom od oko 2 sata.
You should avoid breast-feeding for at least 10 hours after you are given Rapiscan.
Morate izbjegavati dojiti barem 10 sati nakon što primite Rapiscan.
What you need to know before you are given Rapiscan
Što morate znati prije nego primite Rapiscan
When administered twice 10 minutes apart in a 24-hour period, full safety data for the second injection of Rapiscan are not available.
Kod primjene dva puta u razmaku od 10 minuta tijekom razdoblja od 24 sata, kompletni sigurnosni podaci za drugu injekciju Rapiscana nisu dostupni.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100) i rijetko (≥ 1/10 000 do < 1/1000).
AndersonBrecon (UK) Ltd Wye Valley Business Park Hay-on-Wye, Hereford HR3 5PG, United Kingdom
AndersonBrecon (UK) Ltd Wye Valley Business Park Hay-on-Wye, Hereford HR3 5PG,
It may cause other symptoms (headache or shortness of breath) that could affect your ability to drive or use machinery.
Može uzrokovati i druge simptome (glavobolju ili nedostatak zraka) koji mogu utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
Rarely, Rapiscan can cause a stroke (also known as a cerebrovascular accident).
Rijetko, Rapiscan može uzrokovati moždani udar (što se naziva i cerebrovaskularnim inzultom).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, genotoxicity, or embryo-fetal development.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti pojedinačnih i ponovljenih doza, genotoksičnosti ili embriofetalnog razvoja.