FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 101 subjects treated, the median age was 58 years (range 32-87); 53% had HCV genotype 1; 27% had HCV genotype 2; 15% had HCV genotype 3; 4% had HCV genotype 4; 59% were male; 73% were White; 80% were HCV treatment-naïve; 13% had cirrhosis and 65% had a baseline fibrosis state of F0 or F1; 7% were CKD stage 3b; 17% were CKD Stage 4, and 76% were CKD Stage 5 (all receiving dialysis); 84 subjects received 8 weeks of treatment, 13 subjects received 12 weeks of treatment, and 4 subjects received 16 weeks of treatment.
Slovak: U 101 liečených jedincov bol medián veku 58 rokov (rozsah: 32 až 87), 53 % malo HCV genotypu 1; 27 % malo HCV genotypu 2; 15 % malo HCV genotypu 3; 4 % mali HCV genotypu 4; 59 % bolo mužov; 73 % bolo belochov; 80 % bolo predtým neliečených na HCV; 13 % malo cirhózu a 65 % malo východiskový stav fibrózy F0 alebo F1; 7 % bolo v štádiu 3b CKD; 17 % bolo v štádiu 4 CKD a 76 % bolo v štádiu 5 CKD (všetci boli na dialýze); 84 jedincov dostalo 8-týždňovú liečbu, 13 jedincov dostalo 12-týždňovú liečbu a 4 jedinci dostali 16-týždňovú liečbu.
English: No subject experienced virologic failure.
Slovak: U žiadneho jedinca sa nezaznamenalo virologické zlyhanie.
English: − Tablet core: copovidone (Type K 28), vitamin E polyethylene glycol succinate, silica, anhydrous colloidal, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate.
Slovak: Ďalšie zložky sú: Jadro tablety: kopovidón (typ K 28), tokofersolán, oxid kremičitý koloidný bezvodý, propylénglykol monokaprylát (typ II), sodná soľ kroskarmelózy, sodná soľ stearylfumarátu.
English: General disorders and administration site conditions Very common fatigue
Slovak: Celkové poruchy a reakcie v mieste podania Veľmi časté únava
English: Tacrolimus 1 mg single dose
Slovak: Takrolimus 1 mg jednorazová dávka
English: It contains the active substances glecaprevir and pibrentasvir.
Slovak: Obsahuje liečivá glekaprevir a pibrentasvir.
English: Expected: ↓ glecaprevir and ↓ pibrentasvir
Slovak: Očakáva sa: ↓ glekaprevir a ↓ pibrentasvir
English: Maviret for 12 weeks (TN only, n=64) or 16 weeks (TE only, n=51)
Slovak: Maviret počas 12 týždňov (iba TN, n = 64) alebo 16 týždňov (len TE, n
English: Maviret 100 mg/40 mg film-coated tablets glecaprevir/pibrentasvir
Slovak: Maviret 100 mg/40 mg filmom obalené tablety glekaprevir/pibrentasvir
English: (CYP3A4 and P-gp inhibition)
Slovak: (Inhibícia CYP3A4 a P-gp)
English: Among the 10 genotype 1-infected subjects with virologic failure, treatment-emergent NS3 substitutions V36A/M, R155K/T, A156G/T/V, or D168A/T were observed in 7 subjects.
Slovak: Z 10 jedincov infikovaných genotypom 1 s virologickým zlyhaním boli u 7 jedincov pozorované substitúcie V36A/M, R155K/T, A156G/T/V alebo D168A/T v NS3.
English: Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor
Slovak: Pacienti, u ktorých zlyhal predchádzajúci režim s inhibítorom NS5A a/alebo NS3/4A
English: Treatment-experienced with or without cirrhosis
Slovak: Predtým liečení s cirhózou alebo bez nej
English: ↑ tacrolimus
Slovak: ↑ takrolimus
English: Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir.
Slovak: Každá filmom obalená tableta obsahuje 100 mg glekapreviru a 40 mg pibrentasviru.
English: No dose adjustment of Maviret is required in adolescents aged 12 to <18 years (see sections 5.1 and 5.2).
Slovak: 18 rokov nie je potrebná úprava dávky Maviretu (pozri časti 5.1 a 5.2.).
English: Of the 84 subjects treated, the median age was 59 years (range 24-79); 27% had HCV genotype 5, 73% had HCV genotype 6; 54% were female, 30% were White, 68% were Asian; 90% were HCV TN; 11% had compensated cirrhosis.
Slovak: U 84 liečených jedincov bol medián veku 59 rokov (rozsah 24 až 79); 27 % malo HCV genotypu 5; 73 % malo HCV genotypu 6; 54 % bolo žien, 30 % bolo belochov, 68 % bolo aziatov; 90 % nebolo predtým liečených na HCV; 11
English: In TN subjects without cirrhosis who received the recommended duration of 8 weeks, 97.5% (749/768) achieved SVR12, while 0.1% (1/768) experienced on-treatment virologic failure and 0.7% (5/755) experienced post-treatment relapse.
Slovak: U TN jedincov bez cirhózy, ktorí dostali odporúčanú dĺžku liečby 8 týždňov; 97,5 % (749/768) dosiahlo SVR12, zatiaľ čo 0,1
English: Maviret for 8 weeks (n=58)
Slovak: Maviret počas 8 týždňov (n =
English: DAA=direct acting antiviral a. Effect of rifampicin on glecaprevir and pibrentasvir 24 hours after final rifampicin dose.
Slovak: Účinok rifampicínu na glekaprevir a pibrentasvir 24 hodín po poslednej dávke rifampicínu.
English: Adverse reactions observed in greater than or equal to 5% of subjects receiving Maviret for 12 weeks were headache (17%), fatigue (16%), nausea (8%) and pruritus (7%).
Slovak: Nežiaduce reakcie zaznamenané u viac ako alebo najmenej u 5 % jedincov, ktorí dostávali Maviret po dobu 12 týždňov, zahŕňali bolesť hlavy (17
English: What Maviret is and what it is used for 2.
Slovak: 1. Čo je Maviret a na čo sa používa 2. Čo potrebujete vedieť predtým, ako užijete Maviret 3.
English: Purpose of the medicine ciclosporin, tacrolimus to suppress the immune system darunavir, efavirenz, lopinavir, ritonavir for HIV infection digoxin for heart problems fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol warfarin and other similar medicines*
Slovak: Účel lieku cyklosporín, takrolimus na potlačenie imunitného systému darunavir, efavirenz, lopinavir, ritonavir na liečbu infekcie HIV
English: The recommended Maviret treatment durations for HCV genotype 1, 2, 3, 4, 5, or 6 infected patients with compensated liver disease (with or without cirrhosis) are provided in Table 1 and Table 2.
Slovak: 1, 2, 3, 4, 5 alebo 6 s kompenzovaným ochorením pečene (s cirhózou alebo bez nej) sú uvedené v tabuľke 1 a v tabuľke
English: The pharmacokinetic properties of the components of Maviret are provided in Table 11.
Slovak: Maviretu sú uvedené v tabuľke 11.
English: P-gp and not excluded BCRP a. Median Tmax following single doses of glecaprevir and pibrentasvir in healthy subjects.
Slovak: Medián Tmax po jednorazových dávkach glekapreviru a pibrentasviru u zdravých jedincov.
English: Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.
Slovak: Každá tableta obsahuje 100 mg glekapreviru a 40 mg pibrentasviru.
English: Simvastatin 5 mg once daily
Slovak: Simvastatín 5 mg jedenkrát denne
English: Subjects with Genotype 1, 2, 4, 5, or 6 Infection with Cirrhosis who received 8 weeks of Maviret The safety and efficacy of Maviret given for 8 weeks in GT 1, 2, 4, 5 or 6 treatment naïve subjects with compensated cirrhosis was evaluated in a single-arm, open-label study (EXPEDITION-8).
Slovak: Bezpečnosť a účinnosť Maviretu podávaného počas 8 týždňov predtým neliečeným jedincom s genotypom 1, 2, 4, 5 alebo 6 s kompenzovanou cirhózou bola hodnotená v jednoramennej, otvorenej štúdii (EXPEDITION-8).
English: 10 mg once daily
Slovak: 10 mg jedenkrát denne
English: Rosuvastatin 5 mg once daily
Slovak: Rosuvastatín 5 mg jedenkrát denne
English: Glecaprevir and pibrentasvir AUC were similar with and without dialysis (≤ 18% difference) in dialysis-dependent non-HCV infected subjects.
Slovak: Hodnoty AUC glekapreviru a pibrentasviru boli podobné s dialýzou aj bez dialýzy ( ≤
English: Treatment-emergent NS5A substitutions M28G, A30G/K, L31F, P58T, or Y93H were observed in 16 subjects, and 13 subjects had A30K (n=9) or Y93H (n=5) at baseline and posttreatment.
Slovak: U16 jedincov boli v NS5A pozorované substitúcie M28G, A30G/K, L31F, P58T alebo Y93H v NS5A, ktoré sa objavili počas liečby, a u 13 jedincov bola A30K (n =
English: 50 mg single dose
Slovak: 50 mg jednorazová dávka
English: Cirrhosis a. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Slovak: Relaps je definovaný ako HCV RNA ≥
English: (Inhibition of OATP1B1/3, P-gp, BCRP)
Slovak: (Inhibícia OATP1B1/3, P-gp, BCRP)
English: The most commonly reported adverse reactions (incidence ≥ 10%) were headache and fatigue.
Slovak: Najčastejšie hlásené nežiaduce reakcie (výskyt ≥
English: In subjects who are treatment-naïve (TN) or treatment-experienced to combinations of interferon, peginterferon, ribavirin and/or sofosbuvir (TE-PRS) who received the recommended duration, 97.5% (1,252/1,284) achieved SVR12 overall, while 0.3% (4/1,284) experienced on-treatment virologic failure and 0.9% (11/1,262) experienced post-treatment relapse.
Slovak: U jedincov bez predchádzajúcej liečby (TN) alebo s prechádzajúcou liečbou kombináciami interferónu, peginterferónu, ribavirínu a/alebo sofosbuviru (TE-PRS), ktorí dostali odporúčanú dĺžku liečby, celkovo 97,5 % (1252/1284) dosiahlo SVR12, zatiaľ čo 0,3
English: Maviret for 8 weeks (n=199) or 12 weeks (n=25)
Slovak: Maviret počas 8 týždňov (n = 351) alebo 12 týždňov (n =
English: In TN or TE-PRS subjects with compensated cirrhosis who received the recommended duration, 97.0% (288/297) achieved SVR12 (among which 98.0% [192/196] of TN subjects achieved SVR12), while 0.7% (2/297) experienced on-treatment virologic failure and 1.0% (3/289) experienced posttreatment relapse.
Slovak: U TN alebo TE-PRS jedincov s kompenzovanou cirhózou, ktorí dostali odporúčanú dĺžku liečby; 97,0 % (288/297) dosiahlo SVR12 (z toho 98,0 % [192/196]
English: ANTIMYCOBACTERIALS Rifampicin
Slovak: ANTIMYKOBAKTERIÁLNE LIEKY
English: ↑ lovastatin
Slovak: ↑ pravastatín
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovak: ŠPECIFICKÝ IDENTIFIKÁTOR - DVOJROZMERNÝ ČIAROVÝ KÓD Dvojrozmerný čiarový kód so špecifickým identifikátorom.
English: 400 mg single dose
Slovak: 400 mg jednorazová dávka
English: (P-gp/BCRP inhibition)
Slovak: (Inhibícia Pgp/BCRP)
English: Effect on medicinal product levels
Slovak: Účinok na hladiny lieku Cmax
English: 600 mg single dose
Slovak: 600 mg jednorazová dávka
English: Common asthenia
Slovak: Starší pacienti
English: Twenty two of the approximately 2,300 subjects treated with Maviret for 8, 12, or 16 weeks in registrational Phase 2 and 3 clinical studies experienced virologic failure (2 with genotype 1, 2 with genotype 2, 18 with genotype 3 infection).
Slovak: Štúdie u doteraz neliečených jedincov a jedincov s predchádzajúcou liečbou peginterferónom (pegINF), ribavirínom (RBV) a/alebo sofosbuvirom s cirhózou alebo bez cirhózy Dvadsaťdva z približne 2300 jedincov liečených Maviretom počas 8, 12 alebo 16 týždňov v registračných klinických štúdiách fázy 2 a 3 malo virologické zlyhanie (2 s infekciou genotypu 1, 2 s infekciou genotypu 2, 18 s infekciou genotypu 3).
English: (Inhibition of OATP1B1/3, BCRP)
Slovak: (Inhibícia OATP1B1/3, BCRP)
English: Pibrentasvir AUC was similar in Child-Pugh A subjects, 26% higher in Child-Pugh B subjects, and 114% higher in Child-Pugh C subjects.
Slovak: A podľa Childa-Pugha, o 26 % vyššia u jedincov s poruchou triedy
English: Maviret 12 weeks (N=40)
Slovak: Maviret počas 12 týždňov (n=100)
English: None of the GT5 subjects were TE-PRS, and 3 GT6 subjects were TE-PRS.
Slovak: % u genotypov 1, 2, 4, 5 a 6 v uvedenom poradí. Žiadny z jedincov GT5 nebol TE-PRS a 3 jedinci GT6 boli TE-PRS. b.
English: Clinical Study in Subjects with Genotype 5 or 6 Infection ENDURANCE-5,6 was an open-label study in 84 HCV GT5 (N=23) or 6-infected (N=61) TN or TEPRS subjects.
Slovak: ENDURANCE-5,6 bola otvorená štúdia s účasťou 84 jedincov s infekciou HCV GT5 (N =
English: Posology
Slovak: Štúdie
English: No dose adjustment of Maviret is required in patients with mild hepatic impairment (Child-Pugh A).
Slovak: Maviret sa neodporúča u pacientov so stredne ťažkou poruchou funkcie pečene (trieda
English: 300/100 mg once dailyb
Slovak: 300/100 mg jedenkrát denneb
English: Maviret is not recommended in patients with moderate hepatic impairment (Child Pugh-B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3, 4.4, and
Slovak: B podľa Childa-Pugha) a je kontraindikovaný u pacientov s ťažkou poruchou funkcie pečene (trieda C podľa Childa-Pugha) (pozri časti 4.3, 4.4 a 5.2).
English: Of the genotype 1-, 2-, 4-, 5-, or 6-infected subjects with end stage renal disease enrolled in EXPEDITION-4, 97.8% (91/93) achieved SVR12 with no virologic failures.
Slovak: Z jedincov infikovaných genotypom 1, 2, 4, 5 alebo 6 v konečnom štádiu ochorenia obličiek zaradených do štúdie EXPEDITION-4 dosiahlo 97,8
English: HMG-COA REDUCTASE INHIBITORS Atorvastatin
Slovak: INHIBÍTORY HMG-CoA
English: ENDURANCE-2 Maviret (n=202) or Placebo (n=100) for 12 weeks SURVEYOR-2b
Slovak: 202) alebo placebo (n =
English: One subject experienced on-treatment virologic failure (0.6%, 1/168) and no subjects relapsed (0%, 0/166).
Slovak: %, 1/168) a žiaden jedinec nezaznamenal relaps (0
English: • current or previous infection with the hepatitis B virus
Slovak: • infekciu vírusom hepatitídy
English: ↓ glecaprevir ↓ pibrentasvir
Slovak: ↓ glekaprevir ↓ pibrentasvir
English: Propylene glycol monocaprylate (Type II) Croscarmellose sodium
Slovak: Jadro tablety kopovidón (typ K 28) tokofersolán koloidný oxid kremičitý bezvodý propylénglykolmonokaprylát (typ II) sodná soľ kroskarmelózy sodná soľ stearylfumarátu
English: Skin and subcutaneous tissue disorders Not known pruritus
Slovak: Poruchy kože a podkožného tkaniva
English: Pravastatin 10 mg once daily
Slovak: Pravastatín 10 mg jedenkrát denne
English: • feeling very tired (fatigue)
Slovak: • pocit veľkej únavy
English: At the clinical dose, compared to non-HCV infected subjects with normal hepatic function, glecaprevir AUC was 33% higher in Child-Pugh A subjects, 100% higher in Child-Pugh B subjects, and increased to 11-fold in Child-Pugh C subjects.
Slovak: V porovnaní s jedincami bez infekcie HCV s normálnou funkciou pečene bola hodnota AUC glekapreviru v klinickej dávke u jedincov s poruchou triedy
English: Maviret for 8 weeks (n=44) or 16 weeks (n=3)
Slovak: Maviret počas 12 týždňov (n = 66) alebo 16 týždňov (n =
English: Ciclosporin 400 mg single dose
Slovak: Cyklosporín 100 mg jednorazová dávka
English: ↔ glecaprevir ↔ pibrentasvir tacrolimus exposure is expected.
Slovak: Predpokladá sa zvýšenie expozície takrolimu.
English: The median age was 14 years (range: 12 to 17); 79% had HCV genotype 1, 6% had HCV genotype 2, 9% had HCV genotype 3, 6% had HCV genotype 4; 55% were female; 11% were Black; 77% were HCV treatment-naïve; 23% were treatment-experienced to interferon; 4% had HIV-coinfection; none had cirrhosis; the mean weight was 59 kg (range: 32 to 109 kg).
Slovak: Medián veku bol 14 rokov (rozsah: 12 až 17); 79 % malo HCV genotypu 1; 6 % malo HCV genotypu 2; 9 % malo HCV genotypu 3, 6 % malo HCV genotypu 4; 55 % boli ženy; 11
English: Among GT3b subjects without cirrhosis, a numerically lower SVR12 rate of 58.3% (7/12) [62.5% (5/8) for TN subjects and 50% (2/4) for TE-PRS subjects] was observed compared to GT3a subjects without cirrhosis (92.9% (13/14)).
Slovak: u TE-PRS jedincov] v porovnaní s jedincami s GT3a bez cirhózy (92,9 % (13/14)).
English: IMMUNOSUPPRESSANTS Ciclosporin
Slovak: IMUNOSUPRESÍVA
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, AUC, and Cmin) in glecaprevir, pibrentasvir, and the coadministered medicinal product (↑ = increase (more than 25%), ↓ = decrease (more than 20%), ↔ = no change (equal to or less than 20% decrease or 25% increase)).
Slovak: Smer šípky udáva smer zmeny v expozíciách (Cmax, AUC a Cmin) v prípade glekapreviru, pibrentasviru a súbežne podávaného lieku ↑
English: ↑ atorvastatin
Slovak: ↑ atorvastatín
English: norelgestromin ↑ norgestrel
Slovak: ↑ kyselina lovastatínová
English: c. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Slovak: LLOQ po ukončení liečby u tých, ktorí dokončili liečbu.
English: TN and PRS-TE subjects with cirrhosis GT1, 2, 4, 5, 6 EXPEDITION-1 Maviret for 12 weeks (n=146) GT3
Slovak: GT1, 2, 4, 5, 6 EXPEDITION-8 Maviret počas 8 týždňov (n =
English: EXPEDITION-5 was an open-label study in 101 HCV GT1-6 infected subjects without cirrhosis or with compensated cirrhosis and chronic kidney disease (CKD) stage 3b, 4, or 5.
Slovak: Klinická štúdia u jedincov s poruchou funkcie obličiek EXPEDITION-5 bola otvorená štúdia u 101 HCV infikovaných jedincov genotypu 1-6 bez cirhózy alebo s kompenzovanou cirhózou a chronickým ochorením obličiek (CKD) v štádiu 3b, 4 alebo 5. Jedinci boli buď predtým neliečení alebo boli predtým liečení kombináciami (peg) interferónu, ribavirínu a/alebo sofosbuviru a dostávali Maviret počas 8, 12 alebo 16 týždňov podľa schválených trvaní liečby.
English: c. GT3 without cirrhosis from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=29) or 12 weeks (n=54); GT3 without cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=22) or 16 weeks (n=22).
Slovak: GT3 bez cirhózy zo SURVEYOR-2 častí 1 a 2 - Maviret počas 8 týždňov (n =
English: Talk to your doctor before taking Maviret if you are breast-feeding.
Slovak: Ak dojčíte, poraďte sa so svojím lekárom skôr, ako užijete Maviret.
English: Raltegravir 400 mg twice daily
Slovak: Raltegravir 400 mg dvakrát denne (Inhibícia UGT1A1)
English: EXPEDITION-4 Maviret for 12 weeks (n=104)
Slovak: EXPEDITION-2 Maviret počas 8 týždňov (n =
English: In patients with chronic hepatitis C infection without cirrhosis, following 3 days of monotherapy with either glecaprevir 300 mg per day (N=6) or pibrentasvir 120 mg per day (N=8) alone, geometric mean AUC24 values were 13600 ng∙h/mL for glecaprevir and 459 ng∙h/mL for pibrentasvir.
Slovak: 8) boli hodnoty geometrického priemeru AUC24 13 600 ng∙h/ml pre glekaprevir a 459 ng∙h/ml pre pibrentasvir.
English: ↑ rosuvastatin
Slovak: ↑ rosuvastatín
English: b. GT2 from SURVEYOR-2 Parts 1 and 2 - Maviret for 8 weeks (n=54) or 12 weeks (n=25); GT2 from SURVEYOR-2 Part 4 - Maviret for 8 weeks (n=145).
Slovak: GT2 zo SURVEYOR-2 častí 1 a 2 - Maviret počas 8 týždňov (n =
English: ↑ simvastatin acid
Slovak: REDUKTÁZY Atorvastatín
English: ↑ simvastatin
Slovak: ANTIARYTMIKÁ
English: Among subjects with compensated cirrhosis, the overall SVR12 rate for GT3b infected subjects was 87.5% (7/8) [85.7% (6/7) for TN subjects and 100% (1/1) for TE-PRS subjects] and 100% (6/6) for GT3a infected subjects.
Slovak: U jedincov s kompenzovanou cirhózou bola celková miera SVR12 u jedincov infikovaných GT3b 87,5
English: Activity of glecaprevir and pibrentasvir against transient replicons containing NS3 or
Slovak: Tabuľka 6. Aktivita glekapreviru a pibrentasviru proti prechodným replikónom obsahujúcim NS3 alebo NS5A z klinických izolátov HCV genotypu 1-6
English: Absorption
Slovak: Dojčenie
English: GT1, 2, 4, 5, 6 EXPEDITION-8 Maviret for 8 weeks (n=280) (TN only) Subjects with CKD stage 3b, 4 and 5 with or without cirrhosis GT1-6
Slovak: (iba TN) Jedinci s CKD stupeň 3b, 4 a 5 s cirhózou alebo bez nej GT1-6
English: Copovidone (Type K 28)
Slovak: Genotyp (GT)
English: • The active substances are glecaprevir and pibrentasvir.
Slovak: Liečivá sú glekaprevir a pibrentasvir.
English: d. GT3 with cirrhosis from SURVEYOR-2 Part 2 - Maviret for 12 weeks (n=24) or 16 weeks (n=4); GT3 with cirrhosis from SURVEYOR-2 Part 3 - Maviret for 12 weeks (n=40) or 16 weeks (n=47).
Slovak: 4); GT3 s cirhózou zo SURVEYOR-2 časť 3 - Maviret počas 12 týždňov (n =
English: Baseline polymorphisms in NS3 were detected in 1.1% (9/845), 0.8% (3/398), 1.6% (10/613), 1.2% (2/164), 41.9% (13/31), and 2.9% (1/34) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
Slovak: % (13/31) a 2,9 % (1/34) jedincov s infekciou HCV genotypu 1, 2, 3, 4, 5 a 6 v uvedenom poradí.
English: Of the 100 subjects treated, the median age was 60 years (range: 39 to 78); 57% had HCV genotype 1, 13% had HCV genotype 2, 24% had HCV genotype 3, 4% had HCV genotype 4, 2% had HCV genotype 6; 75% were male; 8% were Black; 66% were HCV treatment-naïve; none had cirrhosis and 80% had a baseline fibrosis state of F0 or F1; 80% of subjects were post-liver transplant and 20% were post-kidney transplant.
Slovak: genotypu 6; 75 % bolo mužov; 8 % bolo černochov; 66 % bolo predtým neliečených na HCV; žiadny nemal cirhózu a 80 % malo východiskový stav fibrózy F0 alebo F1; 80 % pacientov bolo po transplantácii pečene a 20 % bolo po transplantácii obličiek.
English: Description
Slovak: PÍSOMNÁ INFORMÁCIA
English: VF=virologic failure a. Percent of subjects with prior treatment experience to PRS is 26%, 14%, 24%, 0%, and 13% for genotypes 1, 2, 4, 5, and 6, respectively.
Slovak: Percento jedincov s predchádzajúcou liečbou PRS je 26 %, 14
English: Treatment-naïve with cirrhosis
Slovak: TN a PRS-TE jedinci s cirhózou
English: ↑ lovastatin acid
Slovak: ZATRIEDENIE LIEKU
English: Elderly
Slovak: Ostatnéd
English: Maviret 12 weeks N=233
Slovak: N=233
English: Lovastatin 10 mg once daily
Slovak: Lovastatín 10 mg jedenkrát denne
English: A 16-week treatment duration should be considered in genotype 3-infected patients who are treatment experienced with peg-IFN + ribavirin +/sofosbuvir, or sofosbuvir + ribavirin.
Slovak: + ribavirínom +/- sofosbuvirom alebo sofosbuvirom + ribavirínom, je potrebné zvážiť 16-týždňové trvanie liečby.
English: What you need to know before you take Maviret Do not take Maviret if:
Slovak: Neužívajte Maviret ak:
English: The following adverse reactions were identified in patients treated with Maviret.
Slovak: Maviretom boli zistené nasledujúce nežiaduce reakcie.
English: However, in some cases this does not happen.
Slovak: V niektorých prípadoch však k tomu nedôjde.
English: These are detailed below:
Slovak: Tieto sú podrobne popísané nižšie:
English: All patients recovered with conventional treatment.
Slovak: Všetci pacienti sa uzdravili pri bežnej liečbe.
English: The following information is intended for medical or healthcare professionals only:
Slovak: Nasledujúca informácia je určená len pre lekárov a zdravotníckych pracovníkov:
English: * see below
Slovak: * pozri nižšie
English: This can cause heart problems in your baby.
Slovak: To môže Vášmu dieťaťu spôsobiť srdcové problémy.
English: Date of first authorisation: 29 July 2004 Date of renewal: 29 July 2009
Slovak: Dátum prvej registrácie: 29. júla 2004
English: Pedea must therefore be used cautiously in the presence of an infection (see also section 4.3).
Slovak: Pedea sa musí preto pri infekcii používať s opatrnosťou (pozri tiež časť 4.3).
English: If you have further questions, please ask your doctor or your pharmacist.
Slovak: - Ak máte ďalšie otázky, obráťte sa na svojho lekára alebo lekárnika.
English: While a baby is inside its mother's womb it does not need to use its lungs.
Slovak: Keď je dieťa v maternici matky, nepotrebuje používať svoje pľúca.
English: The first injection should be given after the first 6 hours of life.
Slovak: Prvá injekcia sa má podať po prvých 6 hodinách života.
English: This medicine has been prescribed for your baby.
Slovak: - Tento liek bol predpísaný Vášmu dieťaťu.
English: However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
Slovak: Je však obtiažne ich odlíšiť od častých komplikácií, ktoré sa vyskytujú u predčasne narodených detí a od komplikácií daných ochorením dieťaťa.
English: For intravenous use only.
Slovak: Len na intravenózne použitie.
English: Careful monitoring of both renal and gastrointestinal function is recommended.
Slovak: Odporúča sa starostlivé monitorovanie funkcie obličiek a gastrointestinálnych funkcií.
English: This medicinal product does not require any special storage conditions.
Slovak: Tento liek nevyžaduje žiadne zvláštne podmienky uchovávania.
English: The apparent volume of distribution is on average 200 ml/kg (62 to 350 according to various studies).
Slovak: Zdanlivý distribučný objem je v priemere 200 ml/kg (62 až 350 podľa rôznych štúdií).
English: There are no preclinical data considered relevant to clinical safety beyond data included in other sections of this Summary of Product Characteristics.
Slovak: Neexistujú žiadne predklinické údaje o klinickej bezpečnosti, ktoré sa dajú považovať za relevantné, okrem údajov zaradených do iných častí tohto Súhrnu charakteristických vlastností lieku.