FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovak: U jedného pacienta sa však zistila v čase virologického zlyhania po 8 týždňoch liečby ledipasvirom/sofosbuvirom v štúdii fázy 2 (LONESTAR) substitúcia S282T v NS5B v kombinácii so substitúciami L31M, Y93H a Q30L v NS5A.
English: GS-331007 ↓ Cmax 0.73 (0.65, 0.83)
Slovak: Cmax 0,73 (0,65; 0,83) ↔
English: IL28 genotype
Slovak: IL28
English: ↑ Cmin 1.47 (1.38, 1.57) Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
Slovak: Cmax 1,68 (1,54; 1,84) ↑
English: Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
Slovak: 191) o 24 % nižšie a o 32 % nižšie, v uvedenom poradí.
English: R-methadone ↔ Cmax 0.99 (0.85, 1.16)
Slovak: Cmax 0,99 (0,85; 1,16) ↔
English: Genotype 1b
Slovak: Genotyp 1a Genotyp 1b
English: Common side effects
Slovak: Hlásenie vedľajších účinkov
English: Refer to the Summary of Product Characteristics for ribavirin for additional information.
Slovak: Ďalšie informácie nájdete v súhrne charakteristických vlastností lieku pre ribavirín.
English: Sofosbuvir ↔ Cmax 1.00 (0.76, 1.32)
Slovak: Cmax 1,00 (0,76; 1,32) ↔
English: LDV/SOF+RBV 8 weeks (n = 210)
Slovak: LDV/SOF+RBV 8 týždňov (n =
English: Table 12: Response rates in study ION-1 LDV/SOF
Slovak: Tabuľka 12: Miery odpovede v štúdii ION-1
English: Sofosbuvir ↔ Cmax 1.12 (0.88, 1.42)
Slovak: Cmax 1,12 (0,88; 1,42) ↔
English: Pravastating
Slovak: VÝDAJA
English: 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
Slovak: Odporúčania týkajúce sa súbežného podávania s Harvoni elvitegravir/ kobicistát/ emtricitabín/ tenofovirdizoproxilfumarát (150 mg/ 150 mg/ 200 mg/ 300 mg jedenkrát denne)/ ledipasvir (90 mg jedenkrát denne)c/ sofosbuvir (400 mg jedenkrát denne)c
English: Forty patients with genotype 4 CHC were enrolled in SOLAR-1 and SOLAR-2 studies, SVR12 were 92% (11/12) and 100% (10/10) in post-transplant patients without decompensated cirrhosis and 60% (6/10) and 75% (6/8) in patients with decompensated cirrhosis (pre- and post-liver transplantation) treated for 12 or 24 weeks, respectively.
Slovak: Štyridsať pacientov s CHC genotypu 4 bolo zaradených do štúdií SOLAR-1 a SOLAR-2, pričom SVR 12 bolo 92 % (11/12) a 100
English: Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77)
Slovak: Cmax 0,64 (0,53; 0,77) ↓
English: Treatment-naïve Patients without cirrhosis 100% (20/20) Patients with cirrhosis Treatment-experienced
Slovak: u predtým neliečených pacientov a 100 % [20/20] u predtým liečených pacientov).
English: Female
Slovak: Muži Ženy
English: Haemoglobin in patients with history of stable cardiac disease
Slovak: Hodnoty hemoglobínu u pacientov s anamnézou stabilného ochorenia srdca poklesne koncentrácia hemoglobínu o ≥
English: ANTIARRHYTHMICS Amiodarone
Slovak: Inhibítor proteázy
English: Table 9: Response rates in study ION-3 LDV/SOF
Slovak: Tabuľka 9: Miery odpovede v štúdii ION-3
English: GS-331007 ↔ Cmax 0.86 (0.76, 0.96)
Slovak: Cmax 0,86 (0,76; 0,96) ↔
English: Lamivudine ↔ Cmax 0.93 (0.87, 1.00)
Slovak: Cmax 0,93 (0,87; 1,00) ↔
English: 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.
Slovak: Do štúdie bolo zaradených 8 pacientov s infekciou HCV genotypu 4, pričom 8/8 dosiahlo SVR12.
English: 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
Slovak: Odporúčania týkajúce sa súbežného podávania s Harvoni emtricitabín/ rilpivirín/ tenofovir-dizoproxilfumarát (200 mg / 25 mg/ 300 mg jedenkrát denne)/ ledipasvir (90 mg jedenkrát denne)c/ sofosbuvir (400 mg jedenkrát denne)c, d emtricitabín ↔
English: In HCV-infected patients with severe renal impairment treated with ledipasvir/sofosbuvir for 12 weeks (n = 18), the pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Slovak: 18), boli farmakokinetické vlastnosti ledipasviru, sofosbuviru a GS-331007 rovnaké ako u HCV negatívnych pacientov so závažným poškodením obličiek.
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)c
Slovak: Inhibítory protónovej pumpy omeprazol (20 mg jedenkrát denne)/ ledipasvir (90 mg jednorazová dávka)c/ sofosbuvir (400 mg jednorazová dávka)c omeprazol podávaný súbežne s Harvoni lanzoprazole rabeprazole pantoprazole ezomeprazole ledipasvir ↓
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14)
Slovak: Cmax 0,97 (0,83; 1,14)
English: Atazanavir ↔ Cmax 1.07 (0.99, 1.14)
Slovak: Cmax 1,07 (0,99; 1,14) ↔
English: Breast-feeding Do not breast-feed during treatment with Harvoni.
Slovak: Počas liečby Harvoni nedojčite.
English: Yesd
Slovak: Ánod
English: Among the 8 patients who had no NS5A RAVs at failure, 7 patients received 8 weeks of treatment (n = 3 with ledipasvir/sofosbuvir; n = 4 with ledipasvir/sofosbuvir + ribavirin) and 1 patient received ledipasvir/sofosbuvir for 12 weeks.
Slovak: 3 s ledipasvirom/sofosbuvirom, n = 4 s ledipasvirom/sofosbuvirom a ribavirínom) a 1 pacient dostával ledipasvir/sofosbuvir počas 12 týždňov.
English: No dose adjustment of Harvoni or darunavir (ritonavir boosted) is required.
Slovak: Nie je potrebná žiadna úprava dávky Harvoni ani darunaviru.
English: Midazolam ↔ Cmax 1.07 (1.00, 1.14)
Slovak: Cmax 1,07 (1,00; 1,14) ↔
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69)
Slovak: Cmax 0,60 (0,53; 0,69) ↔
English: • The active substances are ledipasvir and sofosbuvir.
Slovak: Liečivá sú ledipasvir a sofosbuvir.
English: GS-331007 ↔ Cmax 1.09 (0.99, 1.19)
Slovak: Cmax 1,09 (0,99; 1,19) ↔
English: Efavirenz ↔ Cmax 0.87 (0.79, 0.97)
Slovak: Cmax 0,87 (0,79; 0,97) ↔
English: GS 331007 ↔ Cmax 1.04 (0.97, 1.11)
Slovak: Cmax 1,04 (0,97; 1,11) ↔
English: No dose adjustment of Harvoni or atazanavir (ritonavir boosted) is required.
Slovak: Nie je potrebná žiadna úprava dávky Harvoni ani atazanaviru.
English: Darunavir ↔ Cmax 0.97 (0.94, 1.01)
Slovak: Cmax 0,97 (0,94; 1,01) ↔
English: GS-331007 ↔ Cmax 0.97 (0.90, 1.05)
Slovak: Cmax 0,97 (0,90; 1,05) ↔
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Slovak: Najväčšia časť dávky sofosbuviru vylúčenej v moči bola vo forme GS-331007 (78
English: GS-331007 ↔ Cmax 1.13 (1.07, 1.20)
Slovak: Cmax 1,13 (1,07; 1,20) ↔
English: No significant effects on foetal development have been observed with ledipasvir or sofosbuvir in rats and rabbits.
Slovak: U potkanov a králikov sa nepozorovali žiadne významné účinky ledipasviru ani sofosbuviru na vývoj plodu.
English: ↔ Cmin 0.97 (0.86, 1.10) Ledipasvir ↑ Cmax 1.45 (1.34, 1.56)
Slovak: Cmax 0,97 (0,65; 1,43) ↑
English: Norelgestromin ↔ Cmax 1.07 (0.94, 1.22)
Slovak: Cmax 1,07 (0,94; 1,22) ↔
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Slovak: %, 0 % a 2 % v prípade pacientov dostávajúcich kombinovanú liečbu ledipasvirom/sofosbuvirom a ribavirínom počas 8, 12 a 24 týždňov, v uvedenom poradí.
English: (eGFR ≥30
Slovak: Stredné PO (eGFR ≥
English: ↑ Cmin 2.63 (2.32, 2.97) Ledipasvir ↓ Cmax 0.66 (0.59, 0.75)
Slovak: Cmin 2,36 (2,08; 2,67)
English: GS-331007 ↔ Cmax 1.13 (1.08, 1.19)
Slovak: Cmax 1,13 (1,08; 1,19) ↔
English: Darunavir ↔ Cmax 1.01 (0.96, 1.06)
Slovak: Cmax 1,01 (0,96; 1,06) ↔
English: ↑ Digoxin ↔ Ledipasvir
Slovak: Očakáva sa: ↑ lopinavir ↑ ritonavir
English: HCV protease inhibitor (ION-2).
Slovak: + ribavirínom +/- inhibítorom proteázy HCV.
English: Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively.
Slovak: %) po začatí štúdie boli k dispozícii pre 37/37 a 36/37 pacientov, v uvedenom poradí.
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
Slovak: Cmax 0,63 (0,52; 0,75) ↓
English: ↔ Cmin 1.09 (0.91, 1.31) Norgestrel ↔ Cmax 1.03 (0.87, 1.23)
Slovak: Cmax 1,03 (0,87; 1,23) ↔
English: GS-331007 ↔ Cmax 1.00 (0.94, 1.07)
Slovak: Cmax 1,00 (0,94; 1,07) ↔
English: used to treat HIV infection;
Slovak: Podáva sa na liečbu chronickej (dlhodobej) infekcie vírusom hepatitídy
English: GS-331007 ↑ Cmax 1.33 (1.22, 1.44)
Slovak: Cmax 1,33 (1,22; 1,44) ↑
English: LDV/SOF+RBV 24 weeks (n = 307)a,b
Slovak: LDV/SOF+RBV 24 týždňov (n =
English: ↑ Ledipasvir ↔ Sofosbuvir
Slovak: ↑ digoxín ↔ ledipasvir ↔ sofosbuvir ↔
English: Table 14: Response rates in study ION-2 LDV/SOF
Slovak: Tabuľka 14: Miery odpovede v štúdii ION-2
English: ↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Slovak: Cmax 1,32 (1,25; 1,39) ↑
English: Titanium dioxide
Slovak: tenofovir ↔
English: ↑ Cmin 4.25 (3.47, 5.22) Ledipasvir ↑ Cmax 1.63 (1.51, 1.75)
Slovak: Cmin 4,25 (3,47; 5,22)
English: Study 4063 was an open-label three-arm clinical study that evaluated 8, 12, and 24 weeks of treatment with ledipasvir/sofosbuvir in a total of 95 patients with genotype 1 (72%), 2 (22%), 4 (2%), 5 (1%), or 6 (2%) CHC and ESRD requiring dialysis: 45 treatment-naïve genotype 1 HCV-infected patients without cirrhosis received ledipasvir/sofosbuvir for 8 weeks; 31 treatment-experienced genotype 1
Slovak: Štúdia 4063 bola otvorená trojramenná klinická štúdia, v ktorej sa hodnotilo 8, 12 a 24 týždňov liečby ledipasvirom/sofosbuvirom u celkovo 95 pacientov s CHC genotypu 1 (72
English: Otherc
Slovak: Inéc
English: Patients with renal impairment
Slovak: Pacienti bez cirhózy
English: Harvoni + ribavirinA for 24 weeks (see sections 4.4 and 5.1).
Slovak: Pacienti s kompenzovanou cirhózou a/alebo zlyhaním predchádzajúcej liečby Harvoni + ribavirínA počas 24 týždňov (pozri časti 4.4 a 5.1).
English: Other effects that may be seen during treatment with Harvoni
Slovak: Potenciál účinku iných liekov na Harvoni
English: ↔ Cmin 1.16 (1.08, 1.25) Sofosbuvir ↔ Cmax 1.05 (0.93, 1.20)
Slovak: Cmax 1,05 (0,93; 1,20) ↔
English: b Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2;
Slovak: Jeden pacient v skupine s 8-týždňovou liečbou LDV/SOF nemal potvrdený podtyp genotypu 1. b. Dostupné výsledky testu FibroTest boli priradené ku skóre Metavir nasledovne: 0-0,31 = F0-F1; 0,32-0,58 =
English: Contents of the pack and other information What Harvoni contains
Slovak: Čo Harvoni obsahuje
English: ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, 1.13)
Slovak: Cmax 0,95 (0,79; 1,13) ↔
English: CPT Class C cirrhosis pre-transplant CPT Class B or C cirrhosis posttransplant
Slovak: Pred transplantáciou CPT B
English: LDV/SOF 12 weeks
Slovak: LDV/SOF
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault, median [range] CrCl 22 [17-29] mL/min).
Slovak: Farmakokinetické vlastnosti ledipasviru sa skúmali s jednorazovou dávkou 90 mg ledipasviru u HCV negatívnych pacientov so závažným poškodením obličiek (eGFR <
English: GS-331007 ↔ Cmax 1.06 (0.97, 1.14)
Slovak: Cmax 1,06 (0,97; 1,14) ↔
English: Carbamazepine
Slovak: karbamazepín
English: ↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Slovak: Cmin 1,12 (1,05; 1,20)
English: ↑ Cmin 1.59 (1.49, 1.70) Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Slovak: AUC 1,59 (1,49; 1,70) ↑
English: Following 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin in treatment-experienced patients with compensated cirrhosis (SIRIUS, n = 77), 8/8 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir achieved SVR12.
Slovak: Po 12 týždňoch liečby ledipasvirom/sofosbuvirom s ribavirínom u predtým liečených pacientov s kompenzovanou cirhózou (SIRIUS, n =
English: ↔ Cmin 0.91 (0.83, 0.99) Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Slovak: Cmax 1,08 (0,97; 1,21) ↔
English: Hepatic impairment
Slovak: Predtým neliečení
English: Harvoni.
Slovak: darunavir ↔
English: (Inhibition of CYP3A) Midazolam ↔ Cmax 0.95 (0.87, 1.04)
Slovak: AUC 0,99 (0,95; 1,04) (inhibícia CYP3A)
English: No clinically relevant pharmacokinetic differences due to race have been identified for ledipasvir, sofosbuvir or GS-331007.
Slovak: Pre ledipasvir, sofosbuvir a GS-331007 sa nezistili žiadne klinicky významné farmakokinetické rozdiely v dôsledku rasy.
English: Copovidone
Slovak: amiodarón
English: Norelgestromin ↔ Cmax 1.02 (0.89, 1.16)
Slovak: Cmax 1,02 (0,89; 1,16) ↔
English: Male
Slovak: min/
English: Among the patients who had decompensated cirrhosis (pre- or post-transplant), 64% and 36% were CPT class B and C at screening, respectively, 24% had a baseline Model for End Stage Liver Disease (MELD) score greater than 15.
Slovak: Z 32 pacientov, ktorí mali cirhózu CPT C vo východiskovom stave, malo 53 % (17/32) pacientov 12 týždňov po ukončení liečby cirhózu CPT B.
English: Sofosbuvir ↑ Cmax 1.15 (0.88, 1.50)
Slovak: Cmax 1,15 (0,88; 1,50) ↔
English: ↑ Cmin 1.91 (1.74, 2.10) Ledipasvir ↔ Cmax 1.01 (0.95, 1.07)
Slovak: Cmax 1,01 (0,95; 1,07) ↔
English: • fainting
Slovak: • mdloby.
English: GS-331007 ↔ Cmax 1.10 (1.04, 1.16)
Slovak: Cmax 1,10 (1,04; 1,16) ↔
English: ↔ Cmin 1.08 (0.98, 1.20) Ritonavir ↔ Cmax 1.17 (1.01, 1.35)
Slovak: Cmax 1,08 (0,85; 1,35) ↔
English: Atazanavir ↔ Cmax 1.07 (1.00, 1.15) ↔ AUC 1.33 (1.25, 1.42) ↑ Cmin 1.75 (1.58, 1.93)
Slovak: AUC 1,33 (1,25; 1,42) ↑
English: 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
Slovak: + emtricitabín/ tenofovir-dizoproxilfumarát (200 mg/ 300 mg jedenkrát denne)/ ledipasvir (90 mg jedenkrát denne)c/ sofosbuvir (400 mg jedenkrát denne)c, d súbežné podávanief atazanavir ↔
English: mL/min/1.
Slovak: IU/ml
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Slovak: < 30 ml/min/1,73 m2) a s ESRD vyžadujúcim hemodialýzu sú obmedzené.
English: The 8-week treatment of ledipasvir/sofosbuvir without ribavirin was non-inferior to the 8-week treatment of ledipasvir/sofosbuvir with ribavirin (treatment difference 0.9%; 95% confidence interval: -3.9% to 5.7%) and the 12-week treatment of ledipasvir/sofosbuvir (treatment difference -2.3%; 97.5% confidence interval: -7.2% to 3.6%).
Slovak: % rozdiel v liečbe, 97,5 % interval spoľahlivosti: -7,2 % až 3,6 %).
English: Excipients
Slovak: Belosi
English: Decreases in haemoglobin to < 10 g/dL and < 8.5 g/dL during treatment were experienced by 39% and 13% of patients treated with ledipasvir/sofosbuvir with ribavirin, respectively.
Slovak: Počas liečby došlo u 39 % pacientov liečených ledipasvirom/sofosbuvirom s ribavirínom k poklesu koncentrácie hemoglobínu na <
English: 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
Slovak: + emtricitabín/ tenofovir-dizoproxilfumarát (200 mg/ 300 mg jedenkrát denne)/ ledipasvir (90 mg jedenkrát denne)c/ sofosbuvir (400 mg jedenkrát denne)c, d súbežné podávanief darunavir ↔
English: ↔ Cmin 1.03 (0.97, 1.10) Tenofovir ↑ Cmax 1.64 (1.54, 1.74)
Slovak: Cmax 1,64 (1,54; 1,74) ↑
English: These measures will help to protect the environment .
Slovak: Tieto opatrenia pomôžu chrániť životné prostredie.
English: These effects usually do not last longer than 30 minutes.
Slovak: Tieto účinky zvyčajne netrvajú dlhšie ako 30 minút.
English: • if you are pregnant, think you are pregnant or planning to have a baby.
Slovak: • ak ste tehotná, ak si myslíte, že ste tehotná, alebo ak plánujete otehotnieť.
English: They don't usually need any treatment.
Slovak: Zvyčajne nevyžadujú žiadnu liečbu.
English: The half-life of this initial phase is approximately 2 to 4 minutes.
Slovak: Polčas tejto prvej fázy je približne 2 až 4 minúty.
English: Harmful effects have been seen in animal studies but it is not known if there is a risk to humans.
Slovak: V štúdiách u zvierat sa pozorovali škodlivé účinky, nie je však známe, či existuje riziko pre ľudí.
English: More serious side effects include:
Slovak: Medzi závažnejšie vedľajšie účinky patria:
English: The dose injected does not depend on your weight.
Slovak: Podaná dávka nezávisí od vašej hmotnosti.
English: 400 micrograms
Slovak: 400 mikrogramov
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovak: Pozorne si prečítajte celú písomnú informáciu predtým, ako dostanete tento liek, pretože obsahuje pre vás dôležité informácie.
English: The side effects are usually mild.
Slovak: Tieto vedľajšie účinky sú zvyčajne mierne.
English: The doctor, nurse or medical technician will let you know when you can stand up.
Slovak: Lekár, zdravotná sestra alebo zdravotný technik vám povedia, kedy sa môžete postaviť.
English: • if you have heart failure.
Slovak: • ak máte zlyhanie srdca.
English: Adverse reactions occurred in approximately 80% of patients.
Slovak: Nežiaduce účinky sa vyskytli u približne 80 % pacientov.
English: However, given the proposed duration of use, the effects of the drug transporters are unlikely to be clinically relevant.
Slovak: Pri zohľadnení navrhovanej dĺžky použitia však vplyvy transportérov liekov nie sú pravdepodobne klinicky relevantné.
English: The median time between scans was 7 days (range of 1-104 days).
Slovak: Medián času medzi scintigrafiami bol 7 dní (v rozsahu 1-104 dní).
English: Patients initiated exercise using a standard or modified Bruce protocol.
Slovak: Pacienti začali cvičiť podľa štandardného alebo upraveného Bruceovho protokolu.
English: Regadenoson should not be used during pregnancy unless clearly necessary.
Slovak: Regadenozon sa nemá používať počas gravidity, pokiaľ to nie je nevyhnutné.
English: Most increases resolved within 10 to 15 minutes, but in some cases, increases were observed at 45 minutes following administration.
Slovak: Väčšina zvýšení odoznela do 10 až 15 minút, ale v niektorých prípadoch sa zvýšenia pozorovali 45 minút po podaní.
English: Do not drive or operate machinery until these effects have improved.
Slovak: Neveďte vozidlá a neobsluhujte stroje, kým sa tieto účinky neupravia.
English: 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.
Slovak: Nejedzte jedlo a nepite nápoje obsahujúce kofeín (napríklad čaj, káva, kakao, kola alebo čokoláda) po dobu najmenej 12 hodín predtým, ako dostanete Rapiscan.
English: It is not known whether Rapiscan can pass into breast milk and will only be given to you if your doctor thinks it is necessary.
Slovak: Nie je známe, či Rapiscan môže prechádzať do materského mlieka a preto vám bude podaný iba v prípade, ak to váš lekár bude považovať za potrebné.
English: The healthcare professionals will be responsible for the storage and disposal of this medicinal product.
Slovak: Za uchovávanie a likvidáciu tohto lieku sú zodpovední zdravotnícki pracovníci.
English: The headache was considered severe in 3% of subjects.
Slovak: Bolesť hlavy sa považovala za závažnú u 3 % pacientov.
English: For the measurement of FFR, five independent studies have been conducted.
Slovak: Na meranie FFR bolo vykonaných päť nezávislých štúdií.
English: Rapiscan with food and drink
Slovak: Rapiscan a jedlo a nápoje
English: Children and adolescents Rapiscan should not be used in children and adolescents below the age of 18 years.
Slovak: Deti a dospievajúci Rapiscan sa nemá používať u detí a dospievajúcich mladších ako 18 rokov.
English: Classification agreement Cohen's kappa
Slovak: Zhoda klasifikácie podľa Cohenovej kappa
English: What Rapiscan is and what it is used for
Slovak: Čo je Rapiscan a na čo sa používa
English: Safety and tolerability of repeated use of this product within 24 hours has not been characterised.
Slovak: Bezpečnosť a znášanlivosť opakovaného použitia tohto lieku počas 24 hodín sa neskúmala.
English: However, the maximum observed plasma concentrations as well as volumes of distribution estimates were similar across the groups.
Slovak: Maximálne pozorované plazmatické koncentrácie aj odhady distribučných objemov boli však podobné v rámci všetkých skupín.
English: • if you have low blood pressure (hypotension).
Slovak: • ak máte nízky krvný tlak (hypotenzia).
English: Like all medicines, Rapiscan can cause side effects, although not everybody gets them.
Slovak: Tak ako všetky lieky, aj tento liek môže spôsobovať vedľajšie účinky, hoci sa neprejavia u každého.
English: They normally start soon after the Rapiscan injection and are usually over within 30 minutes.
Slovak: Obvykle začínajú krátko po injekcii Rapiscanu a zvyčajne ustúpia do 30 minút.
English: This belongs to a group of medicines called ‘coronary vasodilators'.
Slovak: Ten patrí do skupiny liekov nazývaných „koronárne vazodilatátory”.
English: Other medicines and Rapiscan
Slovak: Iné lieky a Rapiscan
English: • if you have high blood pressure that is not controlled, especially if this has been accompanied by recent episodes of nose bleed, headache or blurred or double vision.
Slovak: • či máte vysoký krvný tlak, ktorý nie je kontrolovaný, najmä ak bol sprevádzaný nedávnymi epizódami krvácania z nosa, bolesťami hlavy alebo rozmazaným alebo dvojitým videním.
English: Date of first authorisation: 06/09/2010 Date of latest renewal: 24/04/2015
Slovak: Dátum posledného predĺženia registrácie: 24/04/2015
English: The terminal phase consists of a decline in plasma concentration with a half-life of approximately 2 hours.
Slovak: Konečná fáza pozostáva z poklesu plazmatickej koncentrácie s polčasom približne 2 hodiny.
English: Adenosine was treated as a gold standard to estimate sensitivity, specificity, and the proportion of accuracy.
Slovak: Adenozín bol považovaný za zlatý štandard pre odhad senzitivity, špecificity a pomeru presnosti.
English: Repeated use
Slovak: Opakované použitie
English: The risk of significant increases in blood pressure may be higher in patients with uncontrolled hypertension.
Slovak: Riziko významných zvýšení krvného tlaku môže byť vyššie u pacientov s nekontrolovanou hypertenziou.
English: Your doctor will only give you Rapiscan if it is clearly necessary.
Slovak: Váš lekár vám podá Rapiscan, iba ak to bude nevyhnutné.
English: The safety and efficacy of regadenoson in children below the age of 18 years have not yet been established.
Slovak: Bezpečnosť a účinnosť regadenozonu u detí vo veku do 18 rokov neboli doteraz stanovené.
English: • if you have asthma or lung disease.
Slovak: • či máte astmu alebo pľúcne ochorenie.
English: Dyspnoea did not correlate with a decrease in FEV1.
Slovak: Dyspnoe nekorelovalo so znížením hodnoty FEV1.
English: The images from MPI 1 and MPI 2 were compared for presence or absence of perfusion defects.
Slovak: Obrázky z MPI 1 a MPI 2 boli porovnávané na prítomnosť alebo neprítomnosť defektov perfúzie.
English: Bronchoconstriction
Slovak: Bronchokonstrikcia
English: • changes in heart tracing tests (electrocardiogram)
Slovak: • zmeny výsledkov testov na sledovanie činnosti srdca (elektrokardiogram)
English: Suboptimal Exercise Stress Test
Slovak: Suboptimály záťažový test
English: Assessment of adverse reactions for regadenoson is based on safety data from clinical studies and postmarketing experience.
Slovak: Vyhodnotenie nežiaducich účinkov regadenozonu je založené na údajoch o bezpečnosti z klinických štúdií a postmarketingových skúseností.