FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment of Exviera is required for patients with mild, moderate, or severe renal impairment or end-stage-renal disease on dialysis (see section 5.2).
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 Exviery (pozri časť 5.2).
English: Co-administration of Exviera and ombitasvir/paritaprevir/ ritonavir with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QTprolongation coadministered medicinal products.
Slovak: Súbežné podávanie Exviery a ombitasviru/ paritapreviru/ritonaviru s rilpivirínom jedenkrát denne sa môže zvážiť len u pacientov bez známeho
English: SVR12 for HIV-1 co-infected Subjects in TURQUOISE-I
Slovak: Tabuľka 16. SVR12 u pacientov so súbežnou infekciou HIV-1 v štúdii TURQUOISE-I
English: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets
Slovak: Exviera 250 mg filmom obalené tablety
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4) Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4) Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper Limit of Normal
Slovak: 80 - 65 g/l (Stupeň 3) < 65 g/l (Stupeň 4)
English: Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
Slovak: V36A/M, R155K alebo D168V, ktoré sa objavili počas liečby paritaprevirom, boli pozorované v NS3
English: HCV Genotype 1a Exviera and ombitasvir/paritaprevir/ritonavir with RBV
Slovak: HCV genotyp 1a Exviera a ombitasvir/paritaprevir/ritonavir s RBV
English: Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection enzalutamide for prostate cancer ethinylestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception gemfibrozil to lower cholesterol and other fats in the blood mitotane for some tumours of the adrenal glands rifampicin for bacterial infections
Slovak: enzalutamid na liečbu karcinómu prostaty lieky obsahujúce etinylestradiol, ktorý obsahuje väčšina antikoncepčných tabletiek a antikoncepčné vaginálne krúžky na antikoncepciu gemfibrozil na zníženie hladiny cholesterolu a ďalších tukov v krvi mitotán na niektoré zhubné nádory nadobličiek rifampicín na liečbu bakteriálnych infekcií ľubovník bodkovaný (Hypericum perforatum) rastlinný liek na úzkosť a miernu depresiu, tento liek je dostupný bez lekárskeho predpisu
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Slovak: Jedna filmom obalená tableta obsahuje 250 mg dasabuviru (vo forme monohydrátu sodnej soli).
English: SAPPHIRE-I was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 631 treatment-naïve adults with genotype 1 chronic hepatitis C virus infection without cirrhosis.
Slovak: SAPPHIRE-I bola randomizovaná, globálna multicentrická, dvojito zaslepená, placebom kontrolovaná štúdia vykonaná na 631 predtým neliečených dospelých pacientoch s chronickou infekciou vírusom hepatitídy
English: The mean EC50 of dasabuvir against replicons containingNS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
Slovak: EC50 dasabuviru proti replikónom obsahujúcim NS5B zo skupiny doteraz neliečených izolátov genotypu 1a respektíve 1b v teste zameranom na replikónové bunkové kultúry HCV bola 0,77 nM (rozsah 0,4 až 2,1 nM, n =
English: Patients should be informed that fatigue has been reported during treatment with Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin (see section 4.8).
Slovak: Je potrebné informovať pacientov, že počas liečby Exvierou v kombinácii s ombitasvirom/paritaprevirom/ritonavirom a ribavirínom bola hlásená únava (pozri časť 4.8). 4.8 Nežiaduce účinky
English: Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Slovak: Exviera sa neodporúča u pacientov so stredne ťažkou poruchou funkcie pečene (trieda
English: ↑ dabigatran etexilate
Slovak: Očakáva sa: ↑ dabigatránetexilát
English: D168Y V36A
Slovak: V36A
English: Subjects were randomised in a 1:2 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Slovak: Pacienti boli randomizovaní v pomere 1:2 na podávanie Exviery a ombitasviru/paritapreviru/ritonaviru s ribavirínom alebo bez neho počas 12 týždňov liečby.
English: Subjects were randomised in a 1:1 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Slovak: Pacienti boli randomizovaní v pomere 1:1 na podávanie Exviery a ombitasviru/paritapreviru/ritonaviru s ribavirínom alebo bez neho počas 12 týždňov liečby.
English: Ciclosporin 100 mg dosed alone and 30 mg administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Slovak: Cyklosporín 100 mg podávaný samostatne a 30 mg podávaný súbežne s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
English: Exviera and ombitasvir/paritaprevir/ritonavir were given for 12 weeks of treatment in combination with ribavirin.
Slovak: Exviera a ombitasvir/paritaprevir/ritonavir boli podávané počas 12 týždňov liečby v kombinácii s ribavirínom.
English: Mechanism: CYP3A4 inhibition by ritonavir
Slovak: Mechanizmus: inhibícia CYP3A4 ritonavirom
English: ANTIBIOTICS (SYSTEMIC ADMINISTRATION) Sulfamethoxazole, trimethoprim
Slovak: Sulfametoxazol, trimetoprim
English: A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with Exviera + ombitasvir/paritaprevir /ritonavir.
Slovak: NA Pri podávaní s Exvierou + ombitasvirom/paritaprevirom/ritonavirom sa má zvážiť zníženie dávkovania hydrokodónu o 50 % a/alebo klinické monitorovanie.
English: The overall safety profile in HCV-infected transplant recipients who were administered Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin (in addition to their immunosuppressant medicinal products) was similar to subjects treated with Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Slovak: Celkový bezpečnostný profil u pacientov infikovaných HCV po transplantácii pečene, ktorým bola podávaná Exviera a ombitasvir/paritaprevir/ritonavir a ribavirín (popri imunosupresívnych liekoch),
English: Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
Slovak: Mechanizmus: inhibícia OATP1B paritaprevirom a inhibícia BCRP dasabuvirom, paritaprevirom a ritonavirom.
English: Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin were administered for either 12 or 24 weeks of treatment.
Slovak: Exviera a ombitasvir/paritaprevir/ritonavir v kombinácii s ribavirínom boli podávané počas 12- alebo 24-týždňovej liečby.
English: OTHER
Slovak: Ostatné
English: Other a. These virologic failures appear to have resulted from reinfection based on analyses of baseline and virologic failure samples
Slovak: Na základe analýzy východiskového stavu a vzoriek virologického zlyhania sa zdá, že tieto virologické zlyhania boli výsledkom reinfekcie.
English: Contents of the pack and other information
Slovak: Obsah balenia a ďalšie informácie Čo Exviera obsahuje
English: While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Slovak: Aj keď v prípade warfarínu sa neočakáva žiadna zmena vo farmakokinetike,
English: ANTIMYCOBACTERIALS
Slovak: ANTINEOPLASTIKÁ
English: Dose normalized cyclosporine ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Slovak: Pomery cyklosporínu normalizované na dávku sú uvedené pre interakciu s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
English: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets dasabuvir
Slovak: Exviera 250 mg filmom obalené tablety dasabuvir
English: Adverse reactions identified with Exviera in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Slovak: Tabuľka 3. Nežiaduce reakcie zistené pri Exviere v kombinácii s ombitasvirom/paritaprevirom/ritonavirom alebo s ombitasvirom/paritaprevirom/ritonavirom a ribavirínom
English: In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Slovak: V štúdii TURQUOISE-I boli hodnoty SVR12 u pacientov infikovaných HCV so súbežnou infekciou HIV-1 konzistentné s hodnotami SVR12 zistenými v rámci klinických štúdií fázy 3 zameraných na pacientov s monoinfekciou HCV. 7 zo 7 pacientov s infekciou genotypom 1b a 51 z 56 pacientov s infekciou genotypom 1a dosiahlo SVR12.
English: PEARL-III was a randomised, global multicentre, double-blind, controlled trial conducted in 419 treatment-naïve adults with genotype 1b chronic hepatitis C virus infection without cirrhosis.
Slovak: PEARL-III bola randomizovaná, globálna multicentrická, dvojito zaslepená, kontrolovaná štúdia vykonaná na 419 predtým neliečených dospelých pacientoch s chronickou infekciou vírusom hepatitídy
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
Slovak: Mechanizmus: inhibícia CYP3A4/P-gp ketokonazolom a dasabuvirom, paritaprevi rom/ritonavirom /ombitasvirom.
English: ↔ carba mazepine
Slovak: ↔ karba mazepín
English: Tacrolimus 2 mg single dose4
Slovak: 2 mg jednorazová dávka4
English: In subjects with mild, moderate and severe renal impairment, dasabuvir mean AUC values were 21% higher, 37% higher and 50% higher, respectively.
Slovak: U pacientov s miernou, stredne ťažkou a ťažkou poruchou funkcie pečene boli hodnoty AUC o 17 %
English: PEARL-IV was a randomised, global multicentre, double-blind, controlled trial conducted in 305 treatment-naïve adults with genotype 1a chronic hepatitis C virus infection without cirrhosis.
Slovak: PEARL-IV bola randomizovaná, globálna multicentrická, dvojito zaslepená, kontrolovaná štúdia vykonaná na 305 predtým neliečených dospelých pacientoch s chronickou infekciou vírusom hepatitídy
English: Biotransformation
Slovak: Cyklosporín
English: A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 68.4% had IL28B non-CC genotype; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
Slovak: % malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 15,4 % malo portálnu fibrózu (F2) a 8,7 % malo premosťujúcu fibrózu (F3); 67,7 % malo infekciu HCV genotypu 1a; 32,3 % malo infekciu HCV genotypu 1b.
English: PEARL-IV- genotype 1a, treatment-naïve
Slovak: PEARL-IV- genotyp
English: Age, median (range) years Male gender, n (%) IL28B Non-CC genotype, n (%) Prior HCV Treatment:
Slovak: Vek, priemer (rozpätie) roky Mužské pohlavie, n (%)
English: Baseline platelet count, median (× 109/L) < 90, n (%) ≥ 90, n (%) Pooled analyses of clinical trials Durability of response Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Slovak: Dovedna 660 pacientov v klinických skúšaniach fázy 2 a 3 malo výsledky HCV RNA tak v časovom bode SVR12, ako aj SVR24.
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV
Slovak: Rameno A: Exviera a ombitasvir/paritaprevir/ritonavir + RBV
English: No dose adjustment is necessary for emtricitabine/tenofovir and Exviera + ombitasvir/paritaprevir/ ritonavir.
Slovak: Nie je potrebná úprava dávkovania emtricitabínu/tenofoviru a Exviery + ombitasviru/ paritapreviru/ritonaviru.
English: ANTICONVULSANTS carbamazepine
Slovak: ANTIKONVULZÍVA Karbamazepín
English: Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin was given for 12 weeks of treatment.
Slovak: Exviera a ombitasvir/paritaprevir/ritonavir v kombinácii s ribavirínom boli podávané počas 12-týždňovej liečby.
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 81% of subjects had IL28B non-CC genotype; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
Slovak: 63) mali medián veku 51 rokov (rozsah: 31 až 69); 24 % pacientov boli černosi; 81 % pacientov malo genotyp IL28B non-CC;
English: Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Slovak: Rameno B: Exviera a ombitasvir/paritaprevir/ritonavir
English: Resistance to dasabuvir conferred by variants in NS5B selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons.
Slovak: Mutácie NS5B, identifikované v bunkových kultúrach alebo počas klinických štúdií fázy IIb a III,
English: r paritaprevir
Slovak: ↓ paritaprevir
English: In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had a similar SVR12 rate (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (97.7%).
Slovak: V tejto štúdii Exviera a ombitasvir/paritaprevir/ritonavir bez ribavirínu mali podobnú mieru SVR12 (100
English: Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily
Slovak: 200 mg jedenkrát denne/ 300 mg jedenkrát denne
English: Dose normalized tacrolimus ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Slovak: Pomery takrolimu normalizované na dávku sú uvedené pre interakciu s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
English: trimethopri m
Slovak: trimethoprim
English: Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 19.7% had a body mass index of at least 30 kg/m2; 20.7% had a history of depression or bipolar disorder; 69.2% had IL28B non-CC genotype; 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; 19,7 % malo index telesnej hmotnosti najmenej 30 kg/m2; 20,7 % malo v anamnéze depresiu alebo bipolárnu poruchu; 69,2 % malo IL28B non-CC genotyp; 86,6 % malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 18,4
English: Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
Slovak: Koloidný oxid kremičitý (E551)
English: aprevir/ ritonavi r ombitasvir with dasabuvir and ombitasvir/paritaprevir/r itonavir due to increase in paritaprevir exposures (see Summary of Product Characteristics of ombitasvir/paritaprevir/r itonavir).
Slovak: Exviera + ombitasvir/ paritaprevir/ ritonavir ketokonazol nevzťahuje a Súbežné používanie je kontraindikované (pozri súhrn charakteristických vlastností lieku pre ombitasvir/paritaprevir /ritonavir).
English: TURQUOISE-II was a randomised, global multicentre, open-label trial conducted exclusively in 380 genotype 1-infected subjects with compensated cirrhosis (Child-Pugh A) who were either treatmentnaïve or did not achieve SVR with prior treatment with pegIFN/RBV.
Slovak: TURQUOISE-II- pacienti infikovaní genotypom 1, predtým neliečení alebo predtým liečení peginterferónom + ribavirínom s kompenzovanou cirhózou TURQUOISE-II bola randomizovaná, globálna multicentrická, otvorená (open-label) štúdia vykonaná výlučne na 380 dospelých pacientoch infikovaných genotypom 1 s kompenzovanou cirhózou (trieda
English: No dose adjustment of Exviera 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, strednou alebo závažnou poruchou funkcie obličiek alebo v konečnom štádiu ochorenia obličiek na dialýze nie je potrebná úprava dávky Exviery (pozri časť
English: NA No dose adjustment needed for abacavir or lamivudine when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Slovak: NA Nie je potrebná úprava dávkovania abakaviru alebo lamivudínu pri podávaní s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
English: NAME OF THE MARKETING AUTHORISATION HOLDER AbbVie Ltd
Slovak: DRŽITEĽA ROZHODNUTIA O REGISTRÁCII AbbVie
English: Exviera and ombitasvir/paritaprevir/ritonavir for 12 weeks
Slovak: Exviera a ombitasvir/paritaprevir /ritonavir 12 týždňov
English: Exviera and ombitasvir/paritaprevir/ritonavir for 12 weeks With RBV
Slovak: Exviera a ombitasvir/paritaprevir/ritonavir počas 12 týždňov s RBV
English: No dose adjustment is necessary for raltegravir or Exviera + ombitasvir/paritaprevir/ ritonavir.
Slovak: Nie je potrebná úprava dávkovania raltegraviru alebo Exviery + ombitasviru/paritapreviru/ritonaviru.
English: Mechanism: OATP1B inhibition by paritaprevir.
Slovak: Mechanizmus: inhibícia OATP1B paritaprevirom pôsobením ritonaviru.
English: HIV-1 Co-infection
Slovak: INHIBÍTOR HMG-CoA
English: Following a 400 mg 14C-dasabuvir dose, approximately 94% of the radioactivity was recovered in faeces with limited radioactivity (approximately 2%) in urine.
Slovak: Po podaní dávky 400 mg 14C-dasabuviru bolo približne 94 %
English: Exviera ombitas vir/parit aprevir/ ritonavi r atazanavir
Slovak: Exviera + ombitasvir/ paritaprevir/ ritonavir atazanavir
English: SAPPHIRE-I - genotype 1, treatment-naïve
Slovak: Klinické skúšania u predtým neliečených dospelých SAPPHIRE-I - genotyp 1, predtým neliečení pacienti
English: Clinical Comments possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovak: Mechanizmus: pravdepodobne dôsledkom inhibície UGT1A1 paritaprevirom, ombitasvirom a dasabuvirom.
English: NA No dose adjustment is necessary for paracetamol when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Slovak: NA Nie je potrebná úprava dávkovania paracetamolu pri podávaní s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
English: (see also Table 2).
Slovak: (pozri časť 5.3).
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine with or without naloxone (N=19) received 12 weeks of Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
Slovak: Klinické skúšanie u pacientov, ktorí dostávali dlhodobú opioidnú substitučnú terapiu V multicentrickej, otvorenej štúdii fázy 2 s jedným ramenom 38 predtým neliečených pacientov alebo liečených PegIFN/RBV bez cirhózy s infekciou genotypom 1, ktorí boli na stabilných dávkach metadónu (N =
English: NA Concomitant use is contraindicated (see the Summary of Product Characteristics for ombitasvir/paritaprevir/ ritonavir).
Slovak: Podrobnosti pozri v súhrne charakteristických vlastností pre ombitasvir/paritaprevir/ritonavir (pozri aj tabuľku 2).
English: Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 16.5% had a body mass index of at least 30 kg/m2; 9.3% had a history of depression or bipolar disorder; 79.0% had IL28B non-CC genotype; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
Slovak: % boli černosi; 16,5 % malo index telesnej hmotnosti najmenej 30 kg/m2; 9,3 % malo v anamnéze depresiu alebo bipolárnu poruchu; 79,0 % malo IL28B non-CC genotyp; 73,3
English: In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had similar SVR12 rates (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (99.5%).
Slovak: Exviera a ombitasvir/paritaprevir/ritonavir bez ribavirínu neboli non-inferior v porovnaní s Exvierou a ombitasvirom/paritaprevirom/ritonavirom s ribavirínom.
English: ↑ imatinib
Slovak: ↑ takrolimus
English: NA No dose adjustment needed for sofosbuvir when administered with Exviera + ombitasvir/paritaprevir /ritonavir.
Slovak: NA Nie je potrebná úprava dávkovania sofosbuviru pri podávaní s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
English: 400 mg twice daily
Slovak: Raltegravir 400 mg dvakrát denne
English: No dose adjustment needed for dolutegravir when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Slovak: Nie je potrebná úprava dávkovania dolutegraviru pri podávaní s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
English: Prior pegIFN/RBV relapser
Slovak: Predtým neliečení Predtým liečení pegIFN/RBV V minulosti relaps
English: Atazanavir must be administered at dasabuvir ombitasvir
Slovak: Atazanavir sa musí podávať v rovnakom čase ako Exviera+
English: Refer to the Summary of Product Characteristics of ombitasvir/paritaprevir/ritonavir for its pharmacological properties.
Slovak: a v súhrne charakteristických vlastností pre ombitasvir/paritaprevir/ritonavir.
English: Rosuvastatin
Slovak: Pravastatín
English: No dose adjustment is necessary for norethindrone or Exviera + ombitasvir/paritaprevir/ ritonavir.
Slovak: Nie je potrebná úprava dávkovania noretindrónu alebo Exviery + ombitasviru/paritapreviru /ritonaviru.
English: Arm B: Exviera and ombitasvir/paritaprevir/ritonavir + RBV (24 weeks)
Slovak: Rameno B: Exviera a ombitasvir/paritaprevir/ritonavir + RBV
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 16.2% had a body mass index of at least 30 kg/m2; 15.2% had a history of depression or bipolar disorder; 69.3% had IL28B non-CC genotype; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Slovak: 54,5 % z nich boli muži; 5,4 % boli černosi; 16,2 % malo index telesnej hmotnosti najmenej 30 kg/m2; 15,2 % malo v anamnéze depresiu alebo bipolárnu poruchu; 69,3 % malo IL28B non-CC genotyp; 79,1
English: MEDICINAL PRODUCTS USED IN MULTIPLE SCLEROSIS Teriflunomid e
Slovak: LIEKY POUŹÍVANÉ NA SKLERÓZU
English: For contra-indications with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Slovak: Informácie o kontraindikáciách ombitasviru/ paritapreviru/ ritonaviru pozri v súhrne charakteristických vlastností lieku.
English: Smephenytoin
Slovak: Rosuvastatín
English: GIVEN WITH
Slovak: PODÁVANÝ
English: • Itching.
Slovak: • svrbenie.
English: Peginteferon+ribavirin-experienced, without cirrhosis SAPPHIRE II
Slovak: + ribavirínom, bez cirhózy
English: Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 28.4% had a body mass index of at least 30 kg/m2; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 81.8% had IL28B non-CC genotype; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Slovak: % malo index telesnej hmotnosti najmenej 30 kg/m2; 14,7 % malo počet krvných doštičiek nižší ako 90 x 109/l; 49,7 % malo hodnotu albumínu nižšiu ako 40 g/l; 86,1% malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 81,8
English: Lopinavir/ritonavir 400/100 mg twice daily or 800/200 mg once daily is contraindicated dasabuvir
Slovak: Lopinavir/ritonavir 400/100 mg dvakrát denne alebo 800/200 mg jedenkrát denne je kontraindikovaný s dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom kvôli zvýšeniu expozícií paritapreviru (pozri súhrn charakteristických vlastností lieku pre ombitasvir/paritaprevir/ ritonavir ).