natgillin/translations-raw huggingface dataset:
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.
Vpliv predhodnega zdravljenja z ombitasvirjem, paritaprevirjem ali dasabuvirjem na učinkovitost drugih zaviralcev NS5A, zaviralcev proteaz NS3/4A ali zaviralcev NS5B ni raziskan.
CYP3A4 substrates:
Substrati CYP3A4:
Following dosing of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, mean plasma half-life of ombitasvir was approximately 21 to 25 hours.
Po uporabi ombitasvirja/paritaprevirja/ritonavirja (z dasabuvirjem ali brez njega) je bil povprečni plazemski razpolovni čas ombitasvirja približno 21 do 25 ur.
GT1b Viekirax and dasabuvir (8 weeks) Peginterferon+ribavirin experienced -, without cirrhosis SAPPHIRE II
GT1b Viekirax in dasabuvir (8 tednov) Že zdravljeni s peginterferonom + ribavirinom, brez ciroze SAPPHIRE II
Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete
Subjects with HCV GT4 received Viekirax with ribavirin for 12 or 24 Weeks.
Preiskovanci s HCV GT4 so prejemali zdravilo Viekirax z ribavirinom 12 ali 24 tednov.
Following a 200 mg 14C -paritaprevir dose with 100 mg ritonavir, approximately 88% of the radioactivity was recovered in faeces with limited radioactivity (8.8%) in urine.
Po uporabi odmerka 200 mg 14C-paritaprevirja s 100 mg ritonavirja se je približno 88 % radioaktivnosti pojavilo v blatu in le malo radioaktivnosti (približno 8,8 %) v urinu.
Expected ↑ alfuzosin
Pričakovano: ↑ alfuzosin
Genotype 1b, without cirrhosis or with compensated cirrhosis
Genotip 1b, brez ciroze ali s kompenzirano cirozo
Ombitasvir treatment-emergent variants M28T, M28V or Q30R in NS5A were observed in 32 subjects.
Med zdravljenjem z ombitasvirjem nastale variante M28T, M28V ali Q30R gena NS5A so ugotovili pri 32 preiskovancih.
Mechanism: decrease possibly due to CYP1A2 induction by ritonavir
Mehanizem: Možno zmanjšanje zaradi zavrtja CYP1A2 z ritonavirjem.
Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events are contraindicated (see section 4.3 and Table 2).
Kontraindicirana so zdravila, ki so zelo odvisna od očistka s CYP3A in katerih zvišana koncentracija v plazmi je povezana z resnimi učinki (glejte poglavje 4.3 in preglednico 2).
The doses of ombitasvir, paritaprevir, ritonavir were 25 mg 150 mg, 100 mg once daily in PEARL-I, while the dose of paritaprevir was 100 mg or 150 mg in study M12-536.
Odmerki ombitasvirja, paritaprevirja in ritonavirja so bili v študiji PEARL-I 25 mg,150 mg in 100 mg 1-krat na dan, odmerek paritaprevirja v študiji M12-536 pa je bil 100 mg ali 150 mg.
Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Viekirax and dasabuvir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Pri preiskovancih, ki so dobivali zdravilo Viekirax in dasabuvir z ribavirinom, so opažali prehodno zvišanje bilirubina v serumu (pretežno indirektnega), ki je povezano z zavrtjem bilirubinskih prenašalcev OATP1B1/1B3 s paritaprevirjem in s hemolizo zaradi ribavirina.
ANTITPLATELET AGENTS Ticagrelor
ZAVIRALCI AGREGACIJE TROMBOCITOV ticagrelor
Co-administration of Viekirax with or without dasabuvir together with medicinal products that are substrates of BCRP may increase plasma concentrations of these transporter substrates, potentially requiring dose adjustment/clinical monitoring.
Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z zdravili, ki so substrati BCRP, lahko zvišajo koncentracijo teh substratov prenašalcev v plazmi, zato sta lahko potrebna prilagoditev odmerka oziroma klinični nadzor.
Clinical Comments
Klinične opombe
Viekirax without dasabuvir may increase the plasma concentrations of dabigatran etexilate.
Zdravilo Viekirax brez dasabuvirja lahko poveča plazemske koncentracije dabigatran eteksilata.
Atazanavir must be administered at the same time as Viekirax with dasabuvir.
Atazanavir je treba dajati ob istem času kot zdravilo Viekirax in dasabuvir.
In subjects with liver transplant, no cirrhosis and GT1 infection, patients were dosed with Viekirax and dasabuvir for 12-24 weeks, with and without RBV.
Preiskovanci s presajenimi jetri, brez ciroze in z okužbo GT1, so prejemali zdravilo Viekirax in dasabuvir 12-24 tednov, z ali brez RBV.
Clinical Comments inhibition of OATP1B1/B3 and CYP3A by atazanavir and CYP3A by the additional dose of ritonavir.
OATP1B1/B3 in CYP3A z atazanavirjem ter CYP3A z dodatnim odmerkom ritonavirja.
The overall safety profile in HCV-infected transplant recipients who were administered Viekirax and dasabuvir and ribavirin (in addition to their immunosuppressant medications) was similar to subjects treated with Viekirax and dasabuvir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Celotne varnostne značilnosti pri prejemnikih presadka, okuženih s HCV, ki so (poleg imunosupresivnih zdravil) prejemali zdravilo Viekirax in dasabuvir ter ribavirin, je bila podobna kot pri preiskovancih,
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral medicinal products.
Med zdravljenjem ali po zdravljenju z zdravili z direktnim delovanjem na viruse so poročali o reaktivaciji virusa hepatitisa B (HBV), nekateri primeri so bili smrtni.
Medicinal products metabolised by CYP2C9
Zdravila, ki se presnovijo s CYP2C9
200 mg once daily/300 mg once daily
200 mg enkrat na dan/300 mg enkrat na dan
Treatment-naïve, without cirrhosis SAPPHIRE I
Še nezdravljeni, brez ciroze SAPPHIRE I
• Hepatic laboratory testing including direct bilirubin levels should be performed at baseline, during the first 4 weeks of starting treatment and as clinically indicated thereafter.
• na začetku, v prvih 4 tednih po začetku zdravljenja in pozneje kot je klinično indicirano je treba opraviti jetrne laboratorijske teste, vključno z ravnjo direktnega bilirubina,
For immunosuppressive medication, most subjects were taking tacrolimus (81%), with the remainder taking cyclosporine.
61 % jih je bilo pred presaditvijo že zdravljenih za HCV. Kot imunosupresivno terapijo je večina preiskovancev dobivala takrolimus (81 %), ostali pa ciklosporin.
5 mg single dose and other vitamin K antagonists
ANTIKOAGULANTI varfarin enkraten odmerek 5 mg in drugi antagonisti vitamina K
On-treatment virologic failure Post-treatment relapse Other
Virusna neodzivnost med zdravljenjem Recidiv po zdravljenju Drugo
Poly(vinyl alcohol) (E 1203) Macrogol (3350) Talc (E 553b)
Filmska obloga polivinilalkohol (E 1203) makrogol 3350 smukec (E 553b) titanov dioksid (E 171)
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Viekirax.
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Viekirax, nizke ravni sladkorja v krvi
ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4)
(3. stopnja) > 20 × ZNM (4. stopnja)
In this combination, the maximum daily dose of rosuvastatin should be 10 mg (see section 4.5, Table 2).
V tej kombinaciji sme biti največji dnevni odmerek rosuvastatina 10 mg (glejte poglavje 4.5, preglednico 2).
Sirolimus 0.5 mg single dose5
sirolimus 0,5 mg enkratni odmerek5
• alfuzosin hydrochloride
• alfuzosinijev klorid
Liver transplant subjects with cirrhosis were dosed with Viekirax and dasabuvir with RBV (GT1a for 24 weeks [n=4], GT1b for 12 weeks [n=2]).
Preiskovanci s presajenimi jetri z cirozo so prejemali zdravilo Viekirax in dasabuvir z RBV (GT1a 24 tednov [n=4], GT1b 12 tednov [n=2]).
Concomitant use of tacrolimus with Viekirax and dasabuvir is not recommended unless the benefits outweigh the risks (see section 4.4).
Sočasna uporaba takrolimusa z zdravilom Viekirax in dasabuvirjem ni priporočljiva, razen kadar koristi prevladajo nad tveganji (glejte poglavje 4.4).
Paritaprevir is an inhibitor of the hepatic uptake transporters OATP1B1 and OATP1B3, and paritaprevir and ritonavir are inhibitors of OATP2B1.
Paritaprevir zavira jetrna privzemna prenašalca OATP1B1 in OATP1B3, paritaprevir in ritonavir pa zavirata OATP2B1.
Cross-resistance is expected among NS5A inhibitors, NS3/4A protease inhibitors, and non-nucleoside NS5B inhibitors by class.
Po skupini je mogoče navzkrižno odpornost pričakovati med zaviralci NS5A, zaviralci proteaz NS3/4A in nenukleozidnimi zaviralci NS5B.
The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively.
Povprečna EC50 paritaprevirja proti replikonom, ki so vsebovali NS3 iz skupine izolatov še nezdravljenih bolnikov z genotipom 1a in 1b, je bila v preizkusu replikonske celične kulture HCV 0,86 nM (razpon od 0,43 do 1,87 nM, n = 11) za 1a in 0,06 nM (razpon od 0,03 do 0,09 nM, n = 9) za 1b.
Some patients have reported feeling very tired when taking Viekirax with other medicines for their hepatitis C infection.
Nekateri bolniki so poročali o hudi utrujenosti med jemanjem zdravila Viekirax in drugih zdravil za zdravljenje hepatitisa C. Če ste utrujeni, ne vozite ali upravljajte stroje.
Table 2.
preglednico 2).
Nifedipine Mechanism: CYP3A4 inhibition
nifedipin Mehanizem: Zavrtje CYP3A4
PHARMACEUTICAL FORM AND CONTENTS
SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA
Effect of baseline HCV substitutions/polymorphisms on treatment outcome A pooled analysis of subjects with genotype 1 HCV infection, who were treated with ombitasvir, paritaprevir, and dasabuvir (a non-nucleotide NS5B inhibitor) with or without ribavirin in the Phase 2b and 3 clinical trials was conducted to explore the association between baseline NS3/4A, NS5A or NS5B substitutions/polymorphisms and treatment outcome in recommended regimens.
Opravljena je bila kumulativna analiza preiskovancev, okuženih s HCV genotipa 1, ki so bili zdravljeni z ombitasvirjem, paritaprevirjem in dasabuvirjem (nenukleozidnim zaviralcem NS5B), z ribavirinom ali brez njega, v kliničnih preskušanjih faze 2b in 3, za preučitev vpliva izhodiščnih substitucij/polimorfizmov NS3/4A, NS5A oziroma NS5B na izid zdravljenja pri priporočenih shemah.
Mechanism: CYP3A4 induction apalutamide enzalutamide or mitotane.
Indukcija CYP3A4 z apalutamidom, enzalutamidom ali mitotanom
Tacrolimus or sirolimus whole blood concentrations should be monitored upon initiation and throughout co-administration with Viekirax and dasabuvir and the dose and/or dosing frequency should be adjusted as needed.
Koncentracije takrolimusa ali sirolimusa v polni krvi je potrebno spremljati na začetku in vseskozi med sočasno uporabo z zdravilom Viekirax in dasabuvirjem, odmerek in/ali pogostnost odmerjanja je potrebno ustrezno prilagoditi.
Medicinal products renally excreted via transport proteins Ombitasvir, paritaprevir, and ritonavir do not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate).
Ombitasvir, paritaprevir in ritonavir in vivo ne zavirajo prenašalca organskih anionov (OAT1), kar se kaže z odsotnostjo medsebojnega delovanja s tenofovirjem (substrat OAT1).
In Part 2, subjects with HCV GT1 received Viekirax and dasabuvir with or without ribavirin for 12 or 24 weeks.
V delu 2 so preiskovanci s HCV GT1 prejemali zdravilo Viekirax in dasabuvir z ali brez ribavirina 12 ali 24 tednov.
In Part 1b, all subjects received Viekirax and dasabuvir with ribavirin for 12 weeks.
V delu 1b so vsi preiskovanci prejemali zdravilo Viekirax in dasabuvir z ribavirinom 12 tednov.
Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, a 10 year increase or decrease in age from 54 years (median age in the Phase 3 studies) would result in approximately 10%
Na osnovi analize populacijske farmakokinetike iz kliničnih študij 3. faze bi 10-letno povečanje ali zmanjšanje starosti od 54 let (mediana starost v študijah 3. faze) imela za posledico približno 10 % spremembo izpostavljenosti ombitasvirju in ≤ 20 % spremembo izpostavljenosti paritaprevirju.
Viekirax is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.2, 4.3, 4.8 and 5.2).
Zdravilo Viekirax je kontraindicirano pri bolnikih z zmerno do hudo okvaro jeter (Child-Pugh B ali C) (glejte poglavja 4.2, 4.8 in 5.2.
In genotype 1a, substitutions F43L, R155K, A156T, and D168A/F/H/V/Y in HCV NS3 reduced susceptibility to paritaprevir.
Pri genotipu 1a so substitucije F43L, R155K, A156T in D168A/F/H/V/Y v genu NS3 HCV zmanjšale občutljivost za paritaprevir.
In vitro studies show that ombitasvir, paritaprevir, and ritonavir are not inhibitors of organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Študije in vitro kažejo, da ombitasvir, paritaprevir in ritonavir v klinično pomembnih koncentracijah ne zavirajo prenašalcev organskih kationov (OCT2), prenašalcev organskih anionov (OAT3) ali ekstruzijskih beljakovin več zdravil in toksinov (MATE1 in MATE2K).
Side effects when taking Viekirax with dasabuvir and ribavirin:
Neželeni učinki pri jemanju zdravila Viekirax z dasabuvirjem in ribavirinom:
800/160 mg twice daily
800/160 mg dvakrat na dan
Each carton contains 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Ena škatla vsebuje 56 tablet (večkratno pakiranje, ki vsebuje 4 škatle, vsaka s po 14 tabletami).
Viekirax tablets are usually taken with other anti-viral medicines such as “dasabuvir” and “ribavirin”.
Tablete zdravila Viekirax se običajno jemljejo z drugimi protivirusnimi zdravili, kot sta “dasabuvir” in
The combination was not linked to any particular safety issues in a limited set of patients treated for 12-24 weeks.
Pri majhnem številu bolnikov, zdravljenih od 12 do 24 tednov, kombinacije niso spremljale kakšne posebne težave z varnostjo.
Paritaprevir -derived material was minimally transferred through the placenta in pregnant rats.
Iz paritaprevirja nastale snovi so minimalno prehajale skozi placento brejih podgan.
Viekirax with ribavirin & without dasabuvir was evaluated for 12 weeks in genotype 1 treatment naive and treatment experienced non-cirrhotic subjects in a phase 2 study M11-652 (AVIATOR).
Zdravilo Viekirax z ribavirinom in brez dasabuvirja so preučevali 12 tednov pri preiskovancih, okuženih z genotipom 1, brez ciroze, in sicer takih, ki še niso bili zdravljeni kot tudi takih, ki so že bili zdravljeni v študiji 2. faze M11-652 (AVIATOR).
Trazodone should be used with caution and a lower dose of trazodone may be considered.
Trozadon naj se uporablja previdno, v poštev pridejo manjši odmerki.
ALT elevations were asymptomatic and generally occurred during the first 4 weeks of treatment, without concomitant elevations of bilirubin, and declined within approximately two weeks of onset with continued dosing of Viekirax and dasabuvir with or without ribavirin.
tednih zdravljenja, brez hkratnega zvišanja bilirubina; znižala so se v približno dveh tednih po začetku stalne uporabe zdravila Viekirax z dasabuvirjem, z ribavirinom ali brez njega.
The highest documented single dose administered to healthy volunteers was 400 mg for paritaprevir (with 100 mg ritonavir), 200 mg for ritonavir (with 100 mg paritaprevir) and 350 mg for ombitasvir.
Največji dokumentirani enkratni odmerek, uporabljen pri zdravih prostovoljcih, je bil za paritaprevir 400 mg (s 100 mg ritonavirja), za ritonavir 200 mg (s 100 mg paritaprevirja) in za ombitasvir 350 mg. S paritaprevirjem, ritonavirjem ali ombitasvirjem niso opažali s študijo povezanih neželenih učinkov.
Elderly No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2).
Starejši bolniki Starejšim bolnikom odmerkov zdravila Viekirax ni treba prilagoditi (glejte poglavje 5.2).
The European Medicines Agency has deferred the obligation to submit the results of studies with Viekirax in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Viekirax za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with Viekirax with dasabuvir.
300 mg brez ritonavirja, v kombinaciji z zdravilom Viekirax in dasabuvirjem.
Cyclobenzapr ine 5 mg single dose
ciklobenzaprin Posamezni odmerek 5 mg
Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim
Mehanizem: Možno povečanje dasabuvirja zaradi zavrtja CYP2C8 s trimetoprimom.
In the 8.5% of subjects who had ribavirin dose adjustments during therapy, the SVR rate (98.5%) was comparable to subjects who maintained their starting ribavirin dose throughout treatment.
je bil delež SVR (98,5 %) primerljiv tistemu med preiskovanci, ki so začetni odmerek ribavirina ohranili ves čas zdravljenja.
In the genotype 1a replicon, the activity of ombitasvir was reduced by 896-, 58- and 243-fold against the M28T/V and H58D substitutions, respectively, and 1326-, 800-, 155-foldand 1675- to 66740- fold by the Q30E/R, L31V and Y93C/H/N substitutions, respectively.
H58D zmanjšale aktivnost ombitasvirja za 896-,58- in 243-krat, substitucije Q30E/R, L31V in Y93C/H/N pa za 1326-, 800-, 155-krat in 1675- do 66740-krat.
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
12 tednov *Opomba: Pri bolnikih z neznano podvrsto genotipa 1 ali z mešano okužbo z genotipom 1 upoštevajte priporočila za odmerjanje pri genotipu 1a.
Dose normalized sirolimus ratios are shown for interaction with Viekirax + dasabuvir.
Za odmerek normalizirana razmerja sirolimusa so prikazana za medsebojno delovanje z zdravilom Viekirax + dasabuvir.
Note: Doses used for Viekirax and dasabuvir were: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
Opomba: Uporabljeni odmerki zdravila Viekirax in dasabuvirja so bili: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg enkrat na dan in dasabuvir 400 mg dvakrat na dan ali 250 mg dvakrat na dan. Izpostavljenosti dasabuvirju, ki so bile dosežene pri 400 mg formulaciji in 250 mg tableti so podobne.
Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Mehanizem: morda zavrtje UGT1A1 s paritaprevirjem, ombitasvirjem in dasabuvirjem.
The following section describes the specific transporters and metabolizing enzymes that are affected by Viekirax with or without dasabuvir.
Naslednje poglavje opisuje specifične prenašalce in presnovne encime, na katere vpliva zdravilo Viekirax
SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis
SAPPHIRE-I - genotip 1, še nezdravljeni, brez ciroze
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of multipack of 14 film-coated tablets - without blue box
Notranja škatla (večkratno pakiranje) vsebuje 14 filmsko obloženih tablet -brez modrega okenca IME ZDRAVILA
Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
Med zdravljenjem s paritaprevirjem nastale variante V36A/M, R155K ali D168V gena NS3 so ugotovili pri 47 preiskovancih.
If you are not sure, talk to your doctor or pharmacist before taking Viekirax.
Če ste negotovi, se pred začetkom jemanja zdravila Viekirax posvetujte z zdravnikom ali farmacevtom.
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).
Celotni SVR12 HCV genotip 1a Še nezdravljeni Predhodno brez odziva na pegIFN/RBV Predhodno delno odzivni na pegIFN/RBV Predhodno recidiv ob pegIFN/RBV HCV genotip 1b Še nezdravljeni Predhodno brez odziva na pegIFN/RBV Predhodno delno odzivni na pegIFN/RBV Predhodno recidiv ob pegIFN/RBV Izid pri preiskovancih brez SVR12 VN med zdravljenjem 1/208 0,5 Recidiv Drugo a. Za primarne opazovane dogodke učinkovitosti (celotni delež SVR12) so uporabljeni 97,5 % intervali zaupanja; za dodatne opazovane dogodke učinkovitosti (deleži SVR12 pri preiskovancih, okuženih s
The mean EC50 of ombitasvir against replicons containing NS5A from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.66 pM (range 0.35 to 0.88 pM; n=11) and 1.0 pM (range 0.74 to 1.5 pM; n=11), respectively.
Povprečna EC50 ombitasvirja proti replikonom, ki so vsebovali NS5A iz skupine izolatov še nezdravljenih bolnikov z genotipom 1a in 1b, je bil v preizkusu replikonske celične kulture HCV 0,66 pM (razpon od 0,35 do 0,88 pM, n = 11) za 1a in 1,0 pM (razpon od 0,74 do
Methadone ↔ paritaprevir /ombitasvir/dasabuvir (based on the cross study comparison)
↔ S-metadon ↔ paritaprevir/ombitasvir/dasabuvir (na podlagi primerjave med študijami)
Viekirax and dasabuvir with RBV for 12 weeks n/N % 95% CI
Viekirax in dasabuvir z RBV 12 tednov n/N % 95 % IZ
Ethinyloestradiolcontaining oral contraceptives are contraindicated (see section 4.3).
Peroralni kontraceptivi z etinilestradiolom so kontraindicirani (glejte poglavje 4.3).
NA No dose adjustment is necessary for zolpidem.
NA Prilagoditev odmerka zolpidema ni potrebna.
CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (see Table 2).
Med substrati CP2C19, raziskanimi v študijah medsebojnega delovanja zdravil, sta omeprazol in escitalopram (glejte preglednico 2).
Treatment with atazanavir + Viekirax without dasabuvir is not recommended-(↑ paritaprevir).
Zdravljenje z atazanavirjem in zdravilom Viekirax brez dasabuvirja ni priporočljivo - (↑
4.8 Undesirable effects
4.8 Neželeni učinki Povzetek varnostnih značilnosti
Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinyloestradiol.
Zaradi zvišanja ALT sta zdravilo Viekirax in dasabuvir prenehali uporabljati dve osebi; ena od njiju je dobivala etinilestradiol.
Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 18% to 21% higher ombitasvir exposures, and 37% to 39% higher paritaprevir exposures than non-Asian subjects.
Na osnovi analize populacijske farmakokinetike iz kliničnih študij 3. faze so imeli aziati od 18 % do 21 %
The interaction between Viekirax with or without dasabuvir and colchicine has not been evaluated.
Medsebojno delovanje med zdravilom Viekirax z dasabuvirjem ali brez njega ter kolhicinom ni ovrednoteno.
In patients with renal or hepatic impairment, use of colchicine with Viekirax with or without dasabuvir is contraindicated (see sections 4.3 and 4.5).
Pri bolnikih z okvaro ledvic ali jeter je uporaba kolhicina skupaj z zdravilom Viekirax z dasabuvirjem ali brez njega kontraindicirana (glejte poglavji 4.3 in 4.5).
In Part 1a, all subjects received Viekirax and dasabuvir with ribavirin for 12 or 24 weeks.
V delu 1a so vsi preiskovanci prejemali zdravilo Viekirax in dasabuvir z ribavirinom 12 ali 24 tednov.
Package leaflet: Information for the patient Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir This medicine is subject to additional monitoring.
Navodilo za uporabo Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete ombitasvir/paritaprevir/ritonavir Za to zdravilo se izvaja dodatno spremljanje varnosti.
NA If clinically indicated higher doses of omeprazole should be used.
NP Če je klinično indicirano, uporabite večje odmerke omeprazola.
Arm B: Viekirax and dasabuvir + RBV (24 weeks)
Skupina B: Viekirax in dasabuvir + RBV (24 tednov)