FrancophonIA/ELRC3.0 huggingface dataset:
English: Esomeprazole Lansoprazole Mechanism: CYP2C19 induction by ritonavir.
Slovak: Klinické poznámky indukcia CYP2C19 ritonavirom.
English: Similar effect is expected as observed with Viekirax + dasabuvir.
Slovak: Očakáva sa podobný účinok, ako bol zaznamenaný v prípade Viekiraxu + dasabuviru.
English: Overall SVR12 HCV genotype 1a Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers HCV genotype 1b Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers Outcome for subjects without SVR12 On-treatment VF Relapse Other a. 97.5% confidence intervals are used for the primary efficacy endpoints (overall SVR12 rate); 95% confidence intervals are used for additional efficacy endpoints (SVR12 rates in HCV genotype 1a and 1b-infected subjects).
Slovak: 97,5 % intervaly spoľahlivosti sú používané pre primárne cieľové ukazovatele účinnosti (celková miera SVR12); 95 % intervaly spoľahlivosti sú používané pre dodatočné cieľové ukazovatele účinnosti (hodnoty SVR12 pre pacientov infikovaných HCV genotypu 1a a 1b).
English: PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis
Slovak: PEARL-I - genotyp 4, predtým neliečení pacienti alebo pacienti predtým liečení s pegINF + RBV bez cirhózy Dizajn:
English: randomised, global multicentre, open-label
Slovak: randomizované, globálne muticentrické, otvorené
English: Telithromycin
Slovak: Telitromycín
English: SN:
Slovak: Tel.:
English: The EC50 of ombitasvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 14.1 and 5 pM, respectively.
Slovak: EC50 ombitasviru proti genotypu kmeňov 1a-H77 respektíve 1b-Con1 v testoch zameraných na replikónové bunkové kultúry HCV mal hodnoty 14,1 respektíve 5 pM. Aktivita ombitasviru bola oslabená 11- až 13-násobne v prítomnosti 40 % ľudskej plazmy.
English: − Confusion
Slovak: Svrbenie
English: Viekirax and dasabuvir with weight-based ribavirin for 12 weeks
Slovak: Viekirax a dasabuvir s ribavirínom dávkovaným podľa hmotnosti počas 12 týždňov
English: Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir.
Slovak: Mechanizmus: inhibícia CYP3A4/P-gp erytromycínom, paritaprevirom, ritonavirom a dasabuvirom.
English: Viekirax and dasabuvir with or without RBV for 12 or 24 weeks
Slovak: Viekirax a dasabuvir s ribavirínom alebo bez neho počas 12 alebo 24 týždňov
English: Medicinal products metabolised by glucuronidation (UGT1A1) Paritaprevir, ombitasvir and dasabuvir are inhibitors of UGT1A1.
Slovak: Paritaprevir, ombitasvir a dasabuvir sú inhibítormi UGT1A1.
English: Viekirax with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
Slovak: Viekirax s dasabuvirom alebo bez neho spolu s ribavirínom dávkovaným podľa hmotnosti alebo bez neho počas 12 alebo 24 týždňov.
English: Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir.
Slovak: Mechanizmus: inhibícia P-gp paritaprevirom, ritonavirom a dasabuvirom.
English: Paritaprevir/ ritonavir + dasabuvir paritaprevir
Slovak: Paritaprevir/ ritonavir + dasabuvir paritaprevir nevzťahuje sa
English: Disopyramide
Slovak: Dizopyramid
English: Mechanism: CYP3A4 induction apalutamide enzalutamide or mitotane.
Slovak: Mechanizmus: indukcia CYP3A4 apalutamidom, enzalutamidom alebo mitotánom.
English: Prior pegIFN/RBV relapser
Slovak: Ostatné zlyhania PegIFN/RBV SPOLU
English: Mechanism: CYP3A4 inhibition by
Slovak: Mechanizmus: inhibícia CYP3A4/
English: Enzalutamide
Slovak: PODÁVANIA
English: No dose adjustment is necessary for buprenorphine/naloxone and Viekirax with or without dasabuvir.
Slovak: Nie je potrebná úprava dávkovania buprenorfínu/naloxónu a Viekiraxu s dasabuvirom alebo bez neho.
English: Mechanism: BCRP and Pgp inhibition by paritaprevir, ritonavir and dasabuvir
Slovak: Mechanizmus: Inhibícia BCRP a P-gp paritaprevirom, ritonavirom a dasabu
English: Subjects with liver transplant and GT4 infection were dosed with Viekirax with RBV (non-cirrhotic for 12 weeks [n=2] and cirrhotic for 24 weeks [n=1].
Slovak: GT4 dostávali Viekirax s RBV (bez cirhózy 12 týždňov [n =
English: No dose adjustment is necessary for norethindrone or Viekirax with or without dasabuvir.
Slovak: Nie je nutná úprava dávkovania noretindrónu alebo Viekiraxu s dasabuvirom alebo bez neho.
English: Viekirax + dasabuvir rosuvastatin
Slovak: Viekirax + dasabuvir rosuvastatín
English: GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
Slovak: GT1b Rameno A: Viekirax a dasabuvir + RBV Rameno B: Viekirax a dasabuvir
English: Medicines you must tell your doctor about before taking Viekirax Medicine or active substance
Slovak: Lieky, o ktorých musíte informovať svojho lekára predtým, ako začnete užívať
English: ↑ telithromycin ↑ paritaprevir
Slovak: ↑ telitromycín ↑ paritaprevir
English: Viekirax with or without dasabuvir
Slovak: Viekirax s dasabuvirom alebo bez neho
English: Not studied: Similar effect is expected as observed with Viekirax + dasabuvir.
Slovak: Nesledovalo sa, predpokladá sa podobný účinok, ako bol zaznamenaný v prípade Viekiraxu + dasabuviru.
English: Concomitant use is contraindicated (see section
Slovak: Súbežné používanie je kontraindikované (pozri
English: Tacrolimus
Slovak: Gemfibrozil
English: ↑ itraconazole ↑ posaconazole ↑ paritaprevir ↑ dasabuvir
Slovak: Očakáva sa: ↑ diltiazem, verapamil ↑ paritaprevir ↑/↔ dasabuvir
English: Serum ALT elevations
Slovak: Zvýšenie sérového ALT
English: Viekirax without dasabuvir omeprazole
Slovak: Viekirax bez dasabuviru pravastatín
English: pegIFN + RBVexperienced
Slovak: skúsenosť s pegIFN + RBV S RBV
English: PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis
Slovak: PEARL-III - genotyp 1b, predtým neliečení pacienti, bez cirhózy
English: Tell your doctor or pharmacist before taking Viekirax also if you are using hormonal contraceptives.
Slovak: Poraďte sa so svojím lekárom alebo lekárnikom predtým, ako začnete užívať Viekirax, ak: - máte ochorenie pečene iné ako hepatitída C;
English: CYP3A4 induction by phenobarbital.
Slovak: Mechanizmus: indukcia CYP3A4 fenobarbitalom.
English: Sulfamethoxazole, Trimethoprim
Slovak: Sulfametoxazol,
English: Viekirax and dasabuvir with RBV 12 weeks
Slovak: Viekirax a dasabuvir s RBV počas 12 týždňov n/N
English: Caution should be used when sulfasalazine is coadministered with Viekirax with or without dasabuvir.
Slovak: Pri súbežnom podávaní sulfasalazínu s Viekiraxom s dasabuvirom alebo bez neho je potrebná opatrnosť.
English: AGATE-1 -treatment-naïve or pegIFN +RBV experienced patients with compensated cirrhosis
Slovak: AGATE-1 - predtým neliečení pacienti alebo pacienti predtým liečení s pegIFN + RBV
English: THYROID HORMONES
Slovak: HORMÓNY ŠTÍTNEJ ŽĽAZY
English: Expected: ↑ ergot derivatives
Slovak: Očakáva sa: ↑ deriváty ergotu
English: ↑ colchicine
Slovak: ↑ fluvastatín
English: 250 mg single dose
Slovak: Karisoprodol 250 mg jednorazová dávka
English: Contents of the pack and other information What Viekirax contains
Slovak: Čo Viekirax obsahuje
English: Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong inhibitors of CYP3A4 is expected to increase paritaprevir plasma concentrations and must not be co-administered with Viekirax (see section 4.5).
Slovak: CYP3A4 sa predpokladá zvýšenie hladiny plazmatickej koncentrácie paritapreviru nesmú byť súbežne podávané s Viekiraxom (pozri časť 4.5).
English: Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/
Slovak: abakavirom/lamivudínom, dolutegravirom, metformínom, sulfametoxazolom/trimetoprimom, cyklobenzaprínom, karisoprodolom, hydrokodónom/paracetamolom alebo diazepamom, ale nie pre režim Viekirax bez dasabuviru.
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg were not evaluated in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (ChildPugh C) hepatic impairment.
Slovak: Farmakokinetické vlastnosti kombinácie ombitasviru 25 mg, paritapreviru 200 mg a ritonaviru 100 mg neboli hodnotené u pacientov s miernou (trieda
English: • Feeling very tired (fatigue)
Slovak: • pocit veľkej únavy;
English: Expected
Slovak: PODÁVANÝ
English: The safety summary is based on pooled data from phase 2 and 3 clinical trials in subjects who received Viekirax and dasabuvir with or without ribavirin.
Slovak: Súhrn bezpečnostného profilu je založený na súhrnných údajoch z klinických skúšaní fázy 2 a 3
English: The EC50 of paritaprevir against genotype 1a-H77 and 1b-Con1 strains in the HCV replicon cell culture assay was 1.0 and 0.21 nM, respectively.
Slovak: HCV v teste zameranom na replikónové bunkové kultúry mal hodnoty 1,0 respektíve 0,21 nM.
English: Clinical Comments raltegravir exposures may be due to UGT1A1 inhibition by paritaprevir, ombitasvir.
Slovak: Mechanizmus: zvýšenie expozícií raltegraviru môže byť výsledkom inhibície UGT1A1 paritaprevirom, ombitasvirom a dasabuvirom.
English: S-warfarin paritaprevir
Slovak: S-warfarín paritaprevir ombitasvir
English: Subjects (N=135) had a median age of 51 years (range: 19 to 70); 63,7% were treatment-naïve, 17.0% were prior pegIFN/RBV null responders, 6.7% were prior pegIFN/RBV partial responders, 12.6% were prior pegIFN/RBV relapsers; 65.2%were male; 8.9% were Black, 69.6% had baseline HCV RNA levels at least 800,000 IU/mL; 6.7% had bridging fibrosis (F3).
Slovak: 135) mali priemerný vek 51 rokov (rozsah: 19 až 70 rokov); 63,7 % boli pacienti s predchádzajúcou nulovou odpoveďou na PegIFN/RBV, 6,7 % boli pacienti s predchádzajúcou čiastočnou odpoveďou na PegIFN/RBV, 12,6 % boli pacienti s predchádzajúcim relapsom po liečbe
English: ANTICONVULSANTS Carbamazepine
Slovak: ANTIKONVULZÍVA Karbamazepín
English: On-treatment VF Relapse
Slovak: VF počas liečbya
English: • alfuzosin hydrochloride
Slovak: • alfuzosíniumchlorid;
English: Mechanism: CYP3A inhibition by ritonavir
Slovak: Mechanizmus: inhibícia CYP3A ritonavirom.
English: Pitavastatin Mechanism: OATP1B inhibition by paritaprevir
Slovak: Mechanizmus: inhibícia OATP1B/
English: Arm A: Viekirax and dasabuvir + RBV (12 weeks)
Slovak: Rameno A: Viekirax a dasabuvir + RBV
English: ↑ ombitasvir ↑ paritaprevir ↑ dasabuvir
Slovak: bez neho ↑ paritaprevir ↑ dasabuvir
English: • lovastatin, simvastatin, atorvastatin
Slovak: • lovastatín, simvastatín, atorvastatín;
English: Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
Slovak: Mechanizmus: inhibícia CYP3A4 a/alebo P-gp itrakonazolom, posakonazolom a paritaprevirom /ritonavirom/ ombitasvirom.
English: Age, median (range) years Male gender, n (%) Prior HCV Treatment: naïve, n (%) Peg-IFN + RBV, n (%) Baseline albumin, median g/L < 35, n (%)
Slovak: Vek, priemer (rozpätie) roky Mužské pohlavie, n (%)
English: global multicentre, open-label
Slovak: globálne muticentrické, otvorené
English: Arm B: Viekirax and dasabuvir + RBV (24 weeks)
Slovak: Rameno B: Viekirax a dasabuvir + RBV
English: Clinical Comments ombitasvir paritaprevir dasabuvir
Slovak: Klinické poznámky paritaprevir dasabuvir
English: Expected: lomitapide
Slovak: Očakáva sa: ↑ ombitasvir
English: AbbVie SA Belgique/Belgien
Slovak: Belgique/Belgien Tél/Tel:
English: Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Slovak: Mechanizmus: indukcia CYP2C19 a CYP3A4 ritonavirom.
English: Overall SVR12 Outcome for subjects without SVR12 On-treatment VF Relapse Other * Ombitasvir tablets, paritaprevir tablets and ritonavir capsules administered separately.
Slovak: Iné *Tablety ombitasviru, tablety paritapreviru a kapsuly ritonaviru podávané samostatne.
English: No dose adjustment is necessary for methadone and Viekirax with or without dasabuvir.
Slovak: Nie je potrebná úprava dávkovania metadónu a Viekiraxu s dasabuvirom alebo bez neho.
English: General disorders and administration and administration site conditions Very common
Slovak: Celkové poruchy a reakcie v mieste podania
English: ↑ dabigatran etexilate
Slovak: Dabigatránetexilát
English: Mitotane
Slovak: ANTIMYKOTIKÁ
English: Trial
Slovak: Štúdia
English: No dose adjustment needed for Viekirax with or without dasabuvir.
Slovak: Nie je potrebná úprava dávkovania Viekiraxu s dasabuvirom alebo bez neho.
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir paritaprevir
Slovak: Mechanizmus: inhibícia CYP3A4/P-gp ketokonazolom a paritaprevirom/ritonavirom/ombitasvirom.
English: TURQUOISE-II: Relapse Rates by Baseline Laboratory Values after 12 and 24 Weeks of Treatment in Subjects with Genotype 1a Infection and Compensated Cirrhosis
Slovak: Výskyt relapsov u pacientov s infekciou spôsobenou genotypom 1a s kompenzovanou cirhózou podľa východiskových laboratórnych hodnôt
English: GT1 Arm A: Viekirax and dasabuvir + RBV Arm B: Placebo
Slovak: GT1a Rameno A: Viekirax a dasabuvir + RBV Rameno B: Viekirax a dasabuvir
English: Oral midazolam Triazolam
Slovak: Perorálny midazolam Triazolam
English: Viekirax without dasabuvir
Slovak: Viekirax bez dasabuviru
English: The impact of prior ombitasvir, paritaprevir or dasabuvir treatment experience on the efficacy of other NS5A inhibitors, NS3/4A protease inhibitors, or NS5B inhibitors has not been studied.
Slovak: NS5A, inhibítorov proteázy NS3/4A, alebo inhibítorov NS5B.
English: ↓ esomeprazole, lansoprazole
Slovak: Očakáva sa: ↓ ezomeprazol, lanzoprazol
English: Cyclobenzapr ine 5 mg single dose
Slovak: ANTIDEPRESÍVA Escitalopram 10 mg jednorazová dávka
English: No dose adjustment of Viekirax with and without dasabuvir is required for patients with mild, moderate or severe renal impairment , or end-stage-renal disease on dialysis (see section 4.2).
Slovak: U pacientov s miernou, stredne ťažkou alebo ťažkou poruchou funkcie obličiek alebo v konečnom štádiu ochorenia obličiek na dialýze nie je potrebná úprava dávky Viekiraxu s dasabuvirom alebo bez neho (pozri časť 4.2).
English: Results from the pharmacokinetic evaluation of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg can be extrapolated to the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg.
Slovak: 200 mg a ritonaviru 100 mg s dasabuvirom 400 mg možno extrapolovať na kombináciu ombitasviru
English: Smephenytoin
Slovak: Rifampicín
English: ↓ voriconazole ↑ paritaprevir ↑ dasabuvir
Slovak: ↓ vorikonazol ↑ paritaprevir
English: While no dose adjustment is necessary for digoxin, appropriate monitoring of serum digoxin levels is ombitasvir
Slovak: Aj keď v prípade digoxínu nie je potrebná žiadna úprava dávkovania,
English: ↔ ombitasvir paritaprevir ↔ dasabuvir
Slovak: ↓ paritaprevir ↓ dasabuvir
English: ↑ sulfasalazine
Slovak: ↑sulfametoxazol
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir
Slovak: Mechanizmus: možná inhibícia UGT1A1 paritaprevirom, dasabuvirom a ombitasvirom
English: Mechanism: CYP3A4 induction by carbamazepine
Slovak: Mechanizmus: indukcia CYP3A4 karbamazepínom.
English: Mechanism: CYP3A4/Pgp inhibition by clarithromyci n and ritonavir.
Slovak: Mechanizmus: inhibícia CYP3A4/P-gp klaritomycínom a ritonavirom.
English: Breastfeeding
Slovak: Repaglinid
English: Apalutamide
Slovak: Amlodipín
English: Concomitant use of tacrolimus with Viekirax and dasabuvir is not recommended unless the benefits outweigh the risks (see section 4.4).
Slovak: Súbežné používanie takrolimu s Viekiraxom a dasabuvirom sa neodporúča, pokiaľ prínosy neprevyšujú riziká
English: ↑ disopyramide
Slovak: ↑ dizopyramid
English: Poly(vinyl alcohol) (E 1203) Macrogol (3350) Talc (E 553b)
Slovak: Mastenec (E 553b)
English: PC:
Slovak: PC SN
English: No dose adjustment is necessary for raltegravir or Viekirax with or without dasabuvir.
Slovak: Nie je potrebná úprava dávkovania raltegraviru alebo Viekiraxu s dasabuvirom alebo bez neho.
English: Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL increase in
Slovak: Celková SVR12 HCV genotyp 1a HCV genotyp 1b Výsledok pre pacientov bez SVR12
English: Viekirax and dasabuvir without ribavirin for 12 weeks 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
Slovak: 60 pacientov bolo randomizovaných a liečených a 60/60 (100
English: 12 or 24 weeks N = 380 n (%)
Slovak: 11) respektíve 0,06 nM (rozsah 0,03 až 0,09 nM, n =
English: NA No dose adjustment needed for abacavir or lamivudine when coadministered with Viekirax with or without dasabuvir.
Slovak: NA Nie je nutná úprava dávkovania abakaviru alebo lamivudínu a Viekiraxu s dasabuvirom alebo bez neho.
English: Viekirax + dasabuvir duloxetine
Slovak: Viekirax + dasabuvir duloxetín nevzťahuje sa
English: ↑ levothyroxine
Slovak: ↑ klaritromycín
English: SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
Slovak: Tabuľka 8. SVR12 u predtým neliečených pacientov infikovaných genotypom 1b v štúdii
English: • conivaptan
Slovak: SAPPHIRE
English: Viekirax and dasabuvir with RBV 24-week arm
Slovak: Viekirax a dasabuvir s RBV počas
English: ↑ valsartan
Slovak: Lurazidón
English: CYP3A4 inhibition by ritonavir.
Slovak: Klinické poznámky a inhibícia CYP3A4 ritonavirom.
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Slovak: % boli černosi; 20,7 % malo v anamnéze depresiu alebo bipolárnu poruchu; 86,6 % malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 18,4
English: ↑ clarithromycin
Slovak: Metylergometrín
English: Viekirax + dasabuvir furosemide
Slovak: Viekirax + dasabuvir metformín
English: GT1b Viekirax and dasabuvir (8 weeks) Peginterferon+ribavirin experienced -, without cirrhosis SAPPHIRE II
Slovak: Genotyp 1a, s kompenzovanou cirhózou Viekirax + dasabuvir + ribavirín* 24 týždňov (pozri časť 5.1)
English: Indinavir Saquinavir Tipranavir
Slovak: Indinavir Sachinavir
English: NA No dose adjustment needed for sofosbuvir when administered with Viekirax with or without dasabuvir.
Slovak: NA Nie je nutná úprava dávkovania sofosbuviru a Viekiraxu s dasabuvirom alebo bez neho.
English: Treatment with atazanavir + Viekirax without dasabuvir is not recommended-(↑ paritaprevir).
Slovak: Viekirax bez dasabuviru sa neodporúča (↑ paritapre vir).
English: Expected in CYP2C19 Extensive Metabolisers:
Slovak: Očakávané u rýchlych CYP2C19
English: ↑ encorafenib
Slovak: ↑ enkorafenib
English: SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
Slovak: Tabuľka 7. SVR12 u predtým neliečených pacientov infikovaných genotypom 1 v štúdii
English: SVR12 % (n/N) Outcome for subjects without SVR12
Slovak: %) SVR12;
English: There is also a potential risk of autoimmune disease.
Slovak: Existuje aj potenciálne riziko autoimunitného ochorenia.
English: Strimvelis
Slovak: Liek
English: It is not intended to provide practical advice on how to use Strimvelis.
Slovak: Účelom tohto dokumentu nie je poskytnúť praktické rady o tom, ako používať liek Strimvelis.
English: As a result, patients lack the ADA enzyme.
Slovak: Výsledkom je, že pacienti nemajú enzým ADA.
English: Regarding safety, Strimvelis was relatively well tolerated although data are limited due to the small number of patients studied.
Slovak: Pokiaľ ide o bezpečnosť, liek Strimvelis bol pomerne dobre znášaný, aj keď údaje sú obmedzené z dôvodu malého počtu skúmaných pacientov.
English: The most common side effect with Strimvelis (which may affect up to 1 in 10 people) is pyrexia (fever).
Slovak: Najčastejší vedľajší účinok lieku Strimvelis (ktorý môže postihnúť až jednu osobu z desiatich) je pyrexia (horúčka).
English: Other information about Strimvelis
Slovak: Ďalšie informácie o lieku Strimvelis
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Strimvelis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovak: Výbor pre lieky na humánne použitie (CHMP) agentúry rozhodol, že prínosy lieku Strimvelis sú väčšie ako riziká spojené s jeho používaním a odporučil udeliť povolenie na jeho používanie v EÚ.
English: The rate of severe infections declined after treatment and continued to decline with longer-term follow-up beyond 3 years.
Slovak: Miera závažných infekcií po liečbe klesla a pri sledovaní dlhšom ako tri roky naďalej klesala.
English: This is a summary of the European public assessment report (EPAR) for Strimvelis.
Slovak: Tento dokument je súhrn Európskej verejnej hodnotiacej správy (EPAR) o lieku Strimvelis.
English: The dose depends on the bodyweight of the patient.
Slovak: Dávka závisí od telesnej hmotnosti pacienta.
English: A risk management plan has been developed to ensure that Strimvelis is used as safely as possible.
Slovak: Na zaistenie čo najbezpečnejšieho používania lieku Strimvelis bol vypracovaný plán riadenia rizík.
English: However, measures are in place to monitor such events once the medicine is in use by using a registry of patients to study their long-term progress.
Slovak: Sú však zavedené opatrenia na monitorovanie takýchto udalostí, akonáhle sa liek začne používať, a to na základe registra pacientov na skúmanie ich dlhodobého pokroku.
English: All patients were treated with Strimvelis and were still alive 3 years after treatment.
Slovak: Všetci pacienti boli liečení liekom Strimvelis a tri roky po liečbe boli stále nažive.
English: Patients in the study had no appropriate bone marrow donor and alternative treatment had not worked or was not available.
Slovak: Pacienti v štúdii nemali vhodného darcu kostnej drene a alternatívna liečba neúčinkovala alebo nebola k dispozícii.
English: Because Strimvelis is produced using a retrovirus, there could be a potential risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Slovak: Keďže liek Strimvelis sa vyrába pomocou retrovírusu, mohlo vzniknúť riziko rakoviny zapríčinené nežiaducimi zmenami v genetickom materiáli, hoci doteraz sa nepozorovali žiadne takéto prípady.
English: Patients are also given an antihistamine injection just before treatment to reduce the risk of allergic reactions.
Slovak: Pacienti dostanú tesne pred liečbou aj injekciu antihistaminika na zníženie rizika alergických reakcií.
English: These lymphocytes improve the patient's ability to fight infection, and so overcome the symptoms of the condition related to the immune system.
Slovak: Tieto lymfocyty zlepšujú schopnosť pacienta bojovať proti infekcii, a tak prekonať príznaky stavu súvisiaceho s imunitným systémom.
English: Serious side effects with Strimvelis may include effects linked to autoimmunity (when the immune system attacks the body's own cells) such as haemolytic anaemia (low red blood cell counts due to their too rapid breakdown), aplastic anaemia (low blood cell counts due to damaged bone marrow), hepatitis (liver inflammation), thrombocytopenia (low blood platelet count) and Guillain-Barré syndrome (damage to nerves that can result in pain, numbness, muscle weakness and difficulty walking).
Slovak: Strimvelis môžu zahŕňať účinky súvisiace s autoimunitou (ak imunitný systém napáda vlastné bunky tela), ako je hemolytická anémia (nízky počet červených krviniek v dôsledku ich príliš rýchleho rozpadu), aplastická anémia (nízky počet krvných buniek zapríčinený poškodením kostnej drene), hepatitída (zápal pečene), trombocytopénia (nízky počet krvných doštičiek) a Guillainov-Barrého syndróm (poškodenie nervov, ktoré môže viesť k bolesti, necitlivosti, svalovej slabosti a problémom s chôdzou).