natgillin/translations-raw huggingface dataset:
Medicinal products that inhibit CYP3A4 and transport proteins Paritaprevir is eliminated via CYP3A4 mediated metabolism and biliary excretion (substrate of the hepatic transporters OATP1B1, P-gp and BCRP).
Paritaprevir se odstranjuje s presnovo, ki poteka preko CYP3A4, in z izločanjem v žolču (substrat jetrnih prenašalcev OATP1B1, P-gp in BCRP).
600/300 mg once daily
600/300 mg enkrat na dan
In all eight trials, the Viekirax dose was 25 mg/150 mg/100 mg once daily and the dasabuvir dose was 250 mg twice daily.
V vseh osmih preskušanjih je bil odmerek zdravila Viekirax 25 mg/150 mg/100 mg enkrat na dan in odmerek dasabuvirja 250 mg dvakrat na dan. Preiskovanci, ki so dobivali ribavirin, so dobivali odmerek
Contraindicated enzyme inducers are provided in section 4.3 and Table
Primeri kontraindiciranih induktorjev encimov so navedeni v poglavju 4.3 in preglednici 2.
Ombitasvir-derived material was minimally transferred through the placenta in pregnant rats.
Iz ombitasvirja nastale snovi so minimalno prehajale skozi placento brejih podgan.
Co-administration of Viekirax with or without dasabuvir with strong inhibitors of CYP3A may increase paritaprevir concentrations (see section 4.3 and Table 2).
Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z močnimi zaviralci CYP3A lahko poveča koncentracijo paritaprevirja (glejte poglavje 4.3 in preglednico 2).
Not studied; No interaction expected when gemfibrozil is used in combination with Viekirax without dasabuvir.
brez interakcije, če je gemfibrozil uporabljen v kombinaciji z zdravilom Viekirax brez dasabuvirja.
Treated subjects (N=68) had a median age of 58 years (range: 32-77 years); 83.8% were male; 58.8% were Black; 73.5% of subjects were infected with HCV GT1a; 75.0%% had Stage 5 CKD and 69.1% were on haemodialysis.
Zdravljeni preiskovanci (N = 68) so imeli povprečno starost 58 let (razpon: 32-77 let); 83,8 % je bilo moških; 58,8 % je bilo črne rase; 73,5 % preiskovancev je bilo okuženih s HCV GT1a; 75,0 % je imelo
Sirolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax + dasabuvir.
Sirolimus 2 mg je bil uporabljen samostojno, odmerek 0,5 mg pa skupaj z zdravilom Viekirax + dasabuvir.
The efficacy of Viekirax in patients previously exposed to Viekirax, or to medicinal products of the same classes as those of Viekirax (NS3/4A inhibitors or NS5A inhibitors), has not been demonstrated.
Viekirax ali zdravilom iz iste skupine, v katero spada zdravilo Viekirax (zaviralci NS3/4A ali zaviralci NS5A).
randomised, global multicentre, double-blind, regimen-controlled
Oblika preskušanja: randomizirano, globalno, multicentrično, dvojno slepo, s kontrolirano shemo
5 subjects required erythropoietin, all of whom initiated ribavirin at the starting dose of 1000 to 1200 mg daily.
5 preiskovancev je potrebovalo eritropoetin; pri vseh se je zdravljenje z ribavirinom začelo z odmerkom od 1000 do 1200 mg na dan. Noben preiskovanec ni dobil transfuzije krvi.
ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 8-57 days) and most resolved with ongoing therapy.
Z drugimi vrstami estrogenov, ki se pogosto uporabljajo za hormonsko nadomestno zdravljenje (npr. z estradiolom in konjugiranimi estrogeni), niso opažali večje incidence zvišanj ALT. Zvišanja ALT so bila praviloma asimptomatska, po navadi so se pojavila v prvih 4 tednih zdravljenja (povprečni čas 20 dni, razpon od 8 do 57 dni) in so večinoma minila med nadaljevanjem zdravljenja.
Primary SVR12 Assessment for Part 2 Subjects with HCV GT1/HIV-1 co-infection in TURQUOISE-I
Preglednica 17: Primarna SVR12 ocena za del 2, preiskovanci, sočasno okuženi s HCV GT1/HIV-1, v študiji TURQUOISE-I
Ombitasvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (150 mg/kg/day), resulting in ombitasvir AUC exposures approximately 26-fold higher than those in humans at the recommended clinical dose of 25 mg.
Ombitasvir ni bil kancerogen v 6-mesečni študiji pri transgenskih miših vse do največjega testiranega odmerka (150 mg/kg/dan), ki je povzročil približno 26-krat večjo AUC izpostavljenost ombitasvirju, kot je dosežena pri človeku ob priporočenem kliničnem odmerku 25 mg.
How to take Viekirax
Kako jemati zdravilo Viekirax
These medicinal products may show clinically relevant increases in exposures of paritaprevir (e.g., ritonavir with atazanavir, erythromycin, diltiazem or verapamil).
(npr. ritonavir z atazanavirjem, eritromicin, diltiazem ali verapamil).
Viekirax + dasabuvir amlodipine
Viekirax + dasabuvir amlodipin
St. John's Wort (hypericum perforatum)
šentjanževka (hypericum perforatum)
Duloxetine 60 mg single dose
paritaprevir duloksetin enkraten odmerek 60 mg
Treatment-naïve Without RBV
Še nezdravljeni Brez RBV
The activity of paritaprevir was attenuated 24 to 27 -fold in the presence of 40% human plasma.
V prisotnosti 40 % človeške plazme je aktivnost paritaprevirja oslabela za 24- do 27-krat.
OATP1B1 inhibition by paritaprevir.
OATP1B1 z paritaprevirjem.
NA No dose adjustment required for carisoprodol; increase dose if clinically indicated.
NP Prilagoditev odmerka karisoprodola ni potrebna; povečajte odmerek, če je klinično indicirano.
NA No dose adjustment is necessary for duloxetine.
NP Prilagoditev odmerka duloksetina ni potrebna.
The treatment-experienced subjects studied were primarily pegIFN/RBV null responders.
so bili primarno neodzivni na pegIFN/RBV.
While no change to the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Čeprav ni pričakovati nobenih sprememb v farmakokinetiki varfarina, je priporočljivo skrbno spremljanje mednarodnega normaliziranega razmerja (INR) pri vseh antagonistih vitamina K. To je zaradi sprememb delovanja jeter med zdravljenjem z zdravilom Viekirax + dasabuvir.
Arm A: Viekirax and dasabuvir + RBV (12 weeks)
Skupina A: Viekirax in dasabuvir + RBV (12 tednov)
Treatment-emergent amino acid substitutions in the pooled analysis of Viekirax and dasabuvir with and without RBV regimens in Phase 2b and Phase 3 clinical trials (N=2510)
Preglednica 5: Med zdravljenjem nastale aminokislinske substitucije v kumulativni analizi shem z zdravilom Viekirax in dasabuvirjem (z RBV ali brez njega) v kliničnih preskušanjih faze 2b in 3
SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatmentnaïve or previously treated with pegIFN/RBV
Preglednica 13: SVR12 pri preiskovancih, okuženih z genotipom 1, ki so imeli kompenzirano cirozo in še niso bili zdravljeni ali so bili predhodno zdravljeni s pegIFN/RBV.
Caution is advised if co-administering Viekirax with medicinal products that are both moderate inhibitors of CYP3A4 and inhibitors of multiple transporters (P-gp, BCRP and/or OATP1B1/ OATP1B3).
Previdnost je potrebna v primeru sočasne uporabe zdravila Viekirax z zdravili, ki so zmerni zaviralci CYP3A4 in zaviralci več prenašalcev (P-gp, BCRP in/ali
If parenteral midazolam is co-administered with Viekirax with or without dasabuvir, close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised and dosage adjustment should be considered.
Če se sočasno daje midazolam parenteralno in zdravilo Viekirax z dasabuvirjem ali brez njega, je potrebno natančno klinično spremljanje zaradi depresije dihanja in/ali sedacije.
Side effects when taking Viekirax with or without dasabuvir and with or without ribavirin:
Neželeni učinki, ki se lahko pojavijo pri jemanju zdravila Viekirax z ali brez dasabuvirja in z ali brez ribavirina:
Viekirax + dasabuvir duloxetine
Viekirax + dasabuvir duloksetin
Refer to the Summary of Product Characteristics of dasabuvir for its pharmacological properties.
Za farmakološke lastnosti dasabuvirja glejte povzetek glavnih značilnosti zdravila z dasabuvirjem.
Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in non-HCV infected subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment.
Farmakokinetiko kombinacije 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja s 400 mg dasabuvirja so ocenili pri preiskovancih brez okužbe z virusom hepatitisa C z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (Child-Pugh C) okvaro jeter.
↔ ombitasvir/paritaprevir (based on the cross-study comparison)
↔ ombitasvir/paritaprevir/(na podlagi primerjave med študijami)
RUBY-I; treatment-naïve or pegIFN + RBV experienced with or without cirrhosis who have severe renal impairment or end stage renal disease (ESRD)
RUBY-I - še nezdravljeni ali zdravljeni s pegIFN + RBV z ali brez ciroze, ki imajo hudo okvaro ledvic ali končno ledvično odpoved Oblika: multicentrična, odprta
ANTIANGINA/ANTIARRYTHMICS Amiodarone
KONTRACEPTIVI etinilestradiol/n orgestimat
treatment naïve: Viekirax without ribavirin or with weight-based ribavirin for 12 weeks pegIFN + RBV experienced: Viekirax with weight-based ribavirin for 12 weeks
Zdravljenje: še nezdravljeni: zdravilo Viekirax brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov že zdravljeni s kombinacijo pegIFN + RBV: Viekirax z ribavirinom, odvisnim od telesne mase, 12 tednov
ALT elevations
Zvišanja ALT
Upon completion of Viekirax and dasabuvir treatment, the appropriate dose and dosing frequency of tacrolimus should be guided by assessment of tacrolimus blood concentrations.
Klinične opombe dasabuvirjem, je potrebno odmerek in pogostnost odmerjanja takrolimusa nadzirati s pomočjo ocene koncentracij takrolimusa v krvi.
Interactions between Viekirax with or without dasabuvir and other medicinal products
Preglednica 2: Interakcije med zdravilom Viekirax (z dasabuvirjem ali brez njega) in drugimi zdravili
The activity of ombitasvir was attenuated 11- to 13-fold in the presence of 40% human plasma.
V prisotnosti 40 % človeške plazme je aktivnost ombitasvirja oslabela za 11- do 13-krat.
Ciclosporin 100 mg dosed alone, 10 mg administered with Viekirax and 30 mg administered with Viekirax + dasabuvir.
Odmerek 100 mg ciklosporina je bil uporabljen sam, odmerek 10 mg z zdravilom Viekirax in odmerek 30 mg z zdravilom Viekirax + dasabuvirjem.
The persistence of paritaprevir, ombitasvir, and dasabuvir resistance-associated amino acid substitutions in NS3, NS5A, and NS5B, respectively, was assessed in genotype 1a-infected subjects in Phase 2b trials.
Trajnost aminokislinskih substitucij v NS3, NS5A oziroma NS5B, povezanih z odpornostjo proti paritaprevirju, ombitasvirju oziroma dasabuvirju, so ocenili pri preiskovancih, okuženih z genotipom 1a, v preskušanjih faze 2b.
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.
Farmakokinetike kombinacije 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja niso ocenili pri preiskovancih z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (Child-Pugh C) okvaro jeter.
Medicines you must not take with Viekirax Medicine or active substance
Zdravila, ki jih ne smete jemati z zdravilom Viekirax
Transient increases in indirect bilirubin were observed at the highest doses of paritaprevir/ritonavir.
Med uporabo največjih odmerkov paritaprevirja/ritonavirja so opažali prehodno zvišanje indirektnega bilirubina.
Viekirax and dasabuvir without ribavirin for 12 weeks 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
60 bolnikov je bilo randomiziranih in zdravljenih in 60/60 (100 %) jih je doseglo SRV12.
nordiazepam
diazepam
• Itching.
• driska.
Compared to the subjects with normal renal function, paritaprevir Cmax values were comparable, but AUC values were 19%, 33% and 45% higher in mild, moderate and severe renal impairment, respectively.
Vrednosti Cmax paritaprevirja so bile v primerjavi z osebami z normalnim delovanjem ledvic primerljive, vrednosti AUC pa so bile pri bolnikih z blago okvaro ledvic 19 % večje, z zmerno okvaro ledvic 33 % večje in s hudo okvaro ledvic 45 % večje.
Mechanism: Increase in
Mehanizem: Zavrtje
The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑ = increase (more than 20%), ↓ = decrease (of more than 20%), ↔ = no change or change less than 20%).
dasabuvirju in sočasno uporabljenemu zdravilu (↑ = povečanje za več kot 20 %, ↓ = zmanjšanje za več kot
600 mg twice daily
600 mg dvakrat na dan
Ritonavir plasma concentrations increased when renal function was reduced: Cmax and AUC values were 26% to 42% higher, 48% to 80% higher and 66% to 114% higher in subjects with mild, moderate and severe renal impairment, respectively.
Cmax in AUC sta bili od 26 do 42 % večji pri bolnikih z blago okvaro ledvic, od 48 do 80 % večji pri bolnikih z zmerno okvaro ledvic ter od 66 do 114 % večji pri bolnikih s hudo okvaro ledvic.
ANGIOTENSIN RECEPTOR BLOCKER Valsartan
ANTAGONISTI ANGIOTENZINA valsartan losartan kandesartan
In subjects with mild hepatic impairment, paritaprevir, ritonavir and ombitasvir mean Cmax and AUC values decreased by 29% to 48%, 34% to 38% and up to 8%, respectively, compared to subjects with normal hepatic function.
Pri preiskovancih z blago okvaro jeter so bile v primerjavi s preiskovanci z normalnim delovanjem jeter vrednosti naslednje: povprečni Cmax in AUC paritaprevirja sta se zmanjšali za 29 do 48 %, ritonavirja za 34 do 38 % in ombitasvirja do 8 %.
Purpose of the medicine alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, everolimus, sirolimus, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms colchicine for patients whose kidney and liver function test are normal for treating gout attacks or familial Mediterranean fever digoxin, amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan for heart problems or high blood pressure encorafenib for skin cancer furosemide for the build-up of too much fluid in the body hydrocodone for pain levothyroxine for thyroid problems rilpivirine, darunavir, atazanavir for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems ibrutinib, imatinib for the treatment of some cancers of the blood fluvastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol dabigatran to thin the blood fexofenadine for hay fever s-mephenytoin for epilepsy sulfasalazine for inflammatory bowel disease repaglinide for lowering blood sugar erythromycin for bacterial infections steroid or corticosteroid medicines (such as fluticasone)
Namen uporabe zdravila alprazolam, diazepam pri tesnobi, napadih panike in težavah s spanjem ciklosporin, everolimus, sirolimus, takrolimus za zaviranje imunskega sistema ciklobenzaprin, karisoprodol pri mišičnih krčih kolhicin pri bolnikih, ki imajo normalne izvide ledvičnih in jetrnih testov pri protinu ali družinski mediteranski vročici digoksin, amlodipin, nifedipin, valsartan, diltiazem, verapamil, kandesartan, losartan pri težavah s srcem ali visokem krvnem tlaku enkorafenib pri kožnem raku furosemid pri prekomernem kopičenju tekočine v telesu hidrokodon proti bolečini levotiroksin pri težavah s ščitnico rilpivirin, darunavir, atazanavir pri okužbah z virusom HIV
Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Viekirax with and without dasabuvir and with and without ribavirin.
Tveganje za dekompenzacijo jeter in okvaro jeter pri bolnikih s cirozo Pri bolnikih, ki so jih zdravili z zdravilom Viekirax z ali brez dasabuvirja in z ali brez ribavarina so po prihodu zdravila na trg poročali o dekompenzaciji jeter in okvari jeter, vključno s presaditvijo jeter ali smrtnimi izidi.
In Part 1a, SVR12 was achieved by 29/31 (93.5%) subjects on the 12-week arm (95% CI: 79.3%, 98.2%) and by 29/32 (90.6%) subjects on the 24-week arm (95% CI: 75.8% - 96.8%).
98,2 %) in pri 29/32 (90,6 %) preiskovancih v 24-tedenski skupini (95 % CI: 75,8 % - 96,8 %).
Medicinal products transported by P-gp in the intestine While paritaprevir, ritonavir and dasabuvir are in vitro inhibitors of P-gp, no significant change was observed in the exposure of the P-gp substrate digoxin when administered with Viekirax and dasabuvir.
Paritaprevir, ritonavir in dasabuvir in vitro sicer zavirajo P-gp, toda po uporabi z zdravilom Viekirax in dasabuvirjem se izpostavljenost substratu P-gp, digoksinu, ni spremenila.
In genotype 1a, substitutions M28T/V, Q30E/R, L31V, H58D, Y93C/H/N, and M28V + Q30R in HCV NS5A reduced susceptibility to ombitasvir.
Pri genotipu 1a so substitucije M28T/V, Q30ER, L31V, H58D, Y93C/H/N in M28V + Q30R v genu
PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis
PEARL-II - genotip 1b, že zdravljeni s pegIFN + RBV, brez ciroze
Dose normalized cyclosporine ratios are shown for interaction with Viekirax with or without dasabuvir.
Za odmerek normalizirana razmerja ciklosporina so prikazana za medsebojno delovanje z zdravilom Viekirax z dasabuvirjem ali brez njega.
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
Celotni SVR12 HCV genotip 1a HCV genotip 1b Izid pri preiskovancih brez SVR12 VN med zdravljenjema Recidiv Drugob a. Potrjen HCV ≥ 25 i.e./ml po HCV RNA < 25 i.e./ml med zdravljenjem, potrjeno povečanje HCV RNA za 1 log10 i.e./ml od najnižje točke, ali HCV RNA stalno ≥ 25 i.e./ml ob vsaj 6 tednih zdravljenja.
Viekirax, when co-administered with dasabuvir, combines three direct-acting antiviral medicinal products with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Sočasna uporaba zdravila Viekirax z dasabuvirjem združuje tri direktno delujoča protivirusna zdravila z različnimi mehanizmi delovanja.
GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Treatment-naïve and peginterferon+ribavirin -experienced, with compensated cirrhosis
GT1b Skupina A: Viekirax in dasabuvir+ RBV Skupina B: Viekirax in dasabuvir Še nezdravljeni in že zdravljeni peginterferonom + ribavirinom, s kompenzirano cirozo
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medicines after starting Viekirax.
Po začetku jemanja zdravila Viekirax morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
THYROID HORMONES
ŠČITNIČNI HORMONI
Viekirax with or without dasabuvir
Viekirax z ali brez dasabuvirja
300 mg single dose
Posamezni odmerek 300 mg
HCV Genotype 1a Viekirax and dasabuvir with RBV
HCV Genotip 1a Viekirax in dasabuvir z RBV
paritaprevir recommended.
- Navodilo shranite.
GT1 Arm A: Viekirax and dasabuvir + RBV Arm B: Placebo
GT1 Skupina A: Viekirax in dasabuvir + RBV Skupina B: Placebo
Similarly, paritaprevir/ritonavir was not carcinogenic in a 2-year rat study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 8-fold higher than those in humans at 150 mg.
Podobno paritaprevir/ritonavir nista bila kancerogena v 2-letni študiji na podganah vse do največjega testiranega odmerka (300 mg/30 mg/kg/dan), ob čemer je bila AUC izpostavljenost paritaprevirju približno 8-krat večja kot pri človeku ob uporabi 150 mg.
Paritaprevir /ritonavir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 38-fold higher than those in humans at the recommended dose of 150 mg.
Paritaprevir/ritonavir v 6-mesečni študiji pri transgenskih miših nista bila kancerogena vse do največjega testiranega odmerka (300 mg/30 mg/kg/dan), ob čemer je bila AUC izpostavljenost paritaprevirju približno 38-krat večja od izpostavljenosti pri človeku, ob priporočenem odmerku 150 mg.
NA No dose adjustment required for diazepam; increase dose if clinically indicated.
NP Prilagoditev odmerka diazepama ni potrebna; povečajte odmerek, če je klinično indicirano.
Table 2 provides the Least Squares Means Ratio (90% Confidence Interval) effect on concentration of Viekirax with or without dasabuvir and concomitant medicinal products.
Preglednica 2 prikazuje vpliv na koncentracijo zdravila Viekirax (z dasabuvirjem ali brez njega) ter sočasno uporabljanih zdravil z razmerjem povprečij po metodi najmanjših kvadratov (90 % interval zaupanja).
Dose normalized tacrolimus ratios are shown for interaction with Viekirax with or without dasabuvir.
Za odmerek normalizirana razmerja takrolimusa so prikazana za medsebojno delovanje z zdravilom Viekirax z dasabuvirjem ali brez njega.
pegIFN + RBVexperienced
Zdravljeni s pegIFN + RBV
NA No dose adjustment is necessary for escitalopram.
NP Prilagoditev odmerka escitaloprama ni potrebna.
Metabolism as well as biliary excretion of parent drug contribute to the elimination of paritaprevir.
K odstranjevanju paritaprevirja pripomoreta presnova in biliarno izločanje matičnega zdravila.
Concomitant use with efavirenz is contraindicated (see section 4.3).
Sočasna uporaba z efavirenzom je kontraindicirana (glejte poglavje 4.3).
A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with Viekirax.
Med zdravljenjem z zdravilom Viekirax je priporočljivo začasno opustiti suspenzijo pitavastatina/fluvastatina.
NA No dose adjustment required for cyclobenzaprine; increase dose if clinically indicated.
Prilagoditev odmerka ciklobenzaprina ni potrebna; povečajte odmerek, če je klinično indicirano.
Mechanism: CYP3A4 and/or OATP1B inhibition by paritaprevir.
CYP3A4 in/ali OATP1B s paritaprevirjem.
Viekirax and dasabuvir with/without ribavirin for 12 or 24 Weeks N = 200a
Zdravilo Viekirax in dasabuvir z ali brez ribavirina 12 or 24 tednov N = 200a
Treated subjects (N = 22) had a median age of 54 years (range: 34 to 68); 41% were Black; 14% had compensated cirrhosis; 86% were HCV treatment-naïve; 14% had failed prior treatment with pegIFN/RBV; 68% had HCV genotype 1a infection.
Mediana starosti zdravljenih preiskovancev (N = 22) je bila 54 let (razpon: od 34 do 68); 41 % je bilo črncev; 14 % jih je imelo kompenzirano cirozo; 86 % jih še ni bilo zdravljenih; 14 % jih je doživelo neuspeh predhodnega zdravljenja s pegIFN/RBV; 68 % jih je imelo okužbo HCV genotipa 1a.
CYP3A4 induction by phenobarbital.
Indukcija CYP3A4 s fenobarbitalom.
SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Preglednica 11: SVR12 pri preiskovancih, že zdravljenih s peginterferonom + ribavirinom, okuženih z genotipom 1, v preskušanju SAPPHIRE-II
2 mg single dose7
Enkraten odmerek 2 mg 7
Mechanism: CYP3A4/OA TP1B inhibition
CYP3A4/OAT P1B
Similarly, ombitasvir was not carcinogenic in a 2-year rat study up to the highest dose tested (30 mg per kg per day), resulting in ombitasvir exposures approximately 16-fold higher than those in humans at 25 mg.
Podobno, ombitasvir ni bil kancerogen v 2-letni študiji pri podganah, vse do največjega testiranega odmerka (30 mg/kg/dan), ki je povzročil približno 16-krat večjo AUC izpostavljenost ombitasvirju, kot pri človeku pri 25 mg.
No dose adjustment of Viekirax is required in patients with mild hepatic impairment (Child-Pugh A).
Bolnikom z blago okvaro jeter (Child-Pugh A) odmerka zdravila Viekirax ni treba prilagoditi.
Hepatic impairment
Še nezdravljeni
Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir
Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete ombitasvir/paritaprevir /ritonavir
Viekirax and dasabuvir + ribavirin
Viekirax in dasabuvir + ribavirin
• Anaemia (low number of red blood cells)
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov • anemija (majhno število rdečih krvnih celic)