natgillin/translations-raw huggingface dataset:
TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
TURQUOISE-II - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s kompenzirano cirozo Oblika:
The recommended dose of darunavir is 800 mg once daily, without ritonavir, when administered at the same time as ombitasvir/paritaprevir/ ritonavir + dasabuvir (ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide darunavir pharmacokinetic enhancement).
Mehanizem: ni znan paritaprevir se ga daje ob istem času kot ombitasvir/paritap revir/ritonavir + dasabuvir (odmerek ritonavirja v kombinaciji ombitasvir/paritap revir/ritonavir zagotavlja farmakokinetično okrepitev darunavirja).
Co-administration of efavirenz (enzyme inducer) based regimens with paritaprevir /ritonavir + dasabuvir resulted in ALT elevations and therefore, early discontinuation of the study.
+ dasabuvir je povzročila zvišanje ALT in zaradi tega zgodnje prenehanje študije.
How to store Exviera
Shranjevanje zdravila Exviera
Genotype 1b, without cirrhosis or with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir
Trajanje genotip 1b, brez ciroze ali s kompenzirano cirozo dasabuvir + ombitasvir/paritaprevir/ritonavir
Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Skupina A: dasabuvir in ombitasvir/paritaprevir/ritonavir + RBV Skupina B: dasabuvir in ombitasvir/paritaprevir/ritonavir
Expected: ↓ dasabuvir ↓ombitasvir ↓ paritaprevir
Pričakovano: ↓ dasabuvir ↓ ombitasvir ↓ paritaprevir
Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
Skupina A: dasabuvir in ombitasvir/paritaprevir/ritonavir + RBV Skupina B: Placebo
• There is a risk for birth defects when ribavirin is given to a female patient that becomes pregnant.
• Pri dajanju ribavirina bolnicam, ki zanosijo, obstaja tveganje prirojenih okvar pri novorojenčku.
See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Za priporočila o odmerjanju pri bolnikih, sookuženih s HCV/HIV-1, glejte poglavje 4.2.
Croscarmellose sodium Colloidal anhydrous silica (E 551) Magnesium stearate (E 470b)
mikrokristalna celuloza (E 460(i)) laktoza monohidrat kopovidon premreženi natrijev karmelozat koloidni brezvodni silicijev dioksid (E 551) magnezijev stearat (E 470b)
Refer to the tacrolimus or sirolimus Summary of Product Characteristics for additional dosing and monitoring instructions.
Za dodatne informacije glede odmerjanja in navodil za spremljanje glejte Povzetek glavnih značilnosti zdravila za takrolimus oziroma sirolimus.
↑ dabigatran etexilate dasabuvir + ombitasvir/paritaprevir/ ritonavir may increase the plasma concentrations of dabigatran etexilate.
↑ dabigatran eteksilat dasabuvir + ombitasvir/paritap revir/ritonavir lahko zveča koncentracijo dabigatran eteksilata.
DIURETICS Furosemide 20 mg single dose
Posamezen odmerek 20 mg
CYP3A by atazanavir and CYP3A inhibition by the additional dose of ritonavir.
OATP1B1/B3 in CYP3A z atazanavirjem in zavrtja CYP3A z dodatnim odmerkom ritonavirja
Mechanism: P-gp inhibition by dasabuvir, paritaprevir, and ritonavir.
Zavrtje P-gp z dasabuvirjem, paritaprevirjem in ritonavirjem.
The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
ombitasvir/ paritaprevi r/ritonavir dasabuvir atazanavirja je 300 mg, brez ritonavirja, v kombinaciji dasabuvir + ombitasvir/paritap revir/ritonavir.
Do not pass it on to others.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Exviera contains lactose
Zdravilo Exviera vsebuje laktozo
Genotype 1a, with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
12 tednov genotip 1a, s kompenzirano cirozo dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
In genotype 1b, substitutions C316N, C316Y, M414T, Y448H, and S556G in HCV NS5B reduced susceptibility to dasabuvir.
M414T, Y448H in S556G v NS5B HCV zmanjšale občutljivost za dasabuvir.
Concomitant use is contraindicated (see
Sočasna uporaba je kontraindicirana (glejte poglavje
↑ darunavir ↓ dasabuvir ombitasvir paritaprevir lopinavir / ritonavir 400/100 mg dasabu vir + ombitas vir/parit lopinavir
↑ darunavir ↓ dasabuvir ↔ ombitasvir ↓ paritaprevir lopinavir / ritonavir 400/100 mg dvakrat na dan1 Mehanizem:
Sirolimus 2 mg was dosed alone, 0.5 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Sirolimus 2 mg je bil uporabljen samostojno, odmerek 0,5 mg pa skupaj z dasabuvirjem + kombinacijo ombitasvir/paritaprevir/ritonavir.
GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (8 weeks)
GT1b dasabuvir in ombitasvir/paritaprevir/ritonavir (8 tednov)
MUSCLE RELAXANTS Carisoprodol
MIŠIČNI RELAKSANTI
Tacrolimus 2 mg single dose7
AUC Ctrough Klinične opombe takrolimus Posamezen odmerek 2 mg 7
Cross-resistance is expected among NS5A inhibitors, NS3/4A protease inhibitors, and non-nucleoside NS5B inhibitors by class.
NS3/4A in nenukleozidnimi zaviralci NS5B.
Film-coating
Filmska obloga:
Adverse reactions identified with dasabuvir in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Preglednica 3: Neželeni učinki ugotovljeni z dasabuvirjem v kombinaciji z ombitasvir/paritaprevir/ritonavir ali z ombitasvir/paritaprevir/ritonavir in ribavirinom
GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (12 weeks)
GT1b dasabuvir in ombitasvir/paritaprevir/ritonavir (12 tednov)
Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily dasabu vir + ombitas vir/parit aprevir/ ritonavi r
200 mg enkrat na dan/300 mg enkrat na dan dasabuvir ombitasvir/ paritaprevi r/ritonavir emtricitabin
250 mg single dose
karisoprodol Posamezen odmerek 250 mg
Dasabuvir must always be administered together with ombitasvir/paritaprevir/ritonavir .
Dasabuvir je treba vedno uporabiti skupaj z ombitasvirjem/paritaprevirjem/ritonavirjem.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; therefore, ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant.
Pri vseh živalskih vrstah, izpostavljenih ribavirinu, so ugotovili teratogene in/ali embriocidne učinke.
HCV Genotype 1b dasabuvir and ombitasvir/paritaprevir/ritonavir
HCV Genotip 1b dasabuvir in ombitasvir/paritaprevir/ritonavir
ANTIMYCOBACTERIALS Rifampicin
ZDRAVILA Z DELOVANJEM NA BAKTERIJO MYCOBACTERIUM TUBERCULOSIS rifampicin
Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV (24 weeks)
Skupina B: dasabuvir in ombitasvir/paritaprevir/ritonavir + RBV (24 tednov)
Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV
Skupina A: dasabuvir in ombitasvir/paritaprevir/ritonavir + RBV
Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders; and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Zdravljeni preiskovanci (N = 394) so bili mediano stari 54 let (razpon: od 19 do 71); 49,0 % jih predhodno ni imelo odziva na pegIFN/RBV; 21,8 % jih je predhodno imelo delen odziv na pegIFN/RBV in 29,2 % jih je predhodno imelo recidiv ob pegIFN/RBV; 57,6 % je bilo moških; 8,1 % je bilo črncev; 20,6 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 87,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 17,8 % jih je imelo portalno fibrozo (F2) in 14,5 % jih je imelo fibrozo z mostiči (F3); 58,4 % jih je imelo okužbo s HCV genotipa 1a; 41,4 % jih je imelo okužbo s HCV genotipa 1b.
dasabuvir and ombitasvir/paritaprevir /ritonavir + ribavirin
dasabuvir in ombitasvir/paritaprevir /ritonavir + ribavirin
Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders; and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; ; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Zdravljeni preiskovanci (N = 179) so bili mediano stari 57 let (razpon: od 26 do 70); 35,2 % jih predhodno ni imelo odziva na pegIFN/RBV; 28,5 % jih je predhodno imelo delen odziv na pegIFN/RBV in 36,3 % jih je predhodno imelo recidiv ob pegIFN/RBV; 54,2 % je bilo moških; 3,9 % je bilo črncev; 12,8 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 87,7 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 17,9 % jih je imelo portalno fibrozo (F2) in 14,0 % jih je imelo fibrozo z mostiči (F3).
5 mg single dose
Posamezni odmerek 5 mg
No dose adjustment of dasabuvir is required in patients with mild hepatic impairment (Child-Pugh A).
Bolnikom z blago okvaro jeter (Child-Pugh A) odmerkov dasabuvirja ni treba prilagoditi.
HCV Genotype 1a dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV
HCV Genotip 1a dasabuvir in ombitasvir/paritaprevir/ritonavir Z RBV
Stop taking Exviera and talk to your doctor or get medical help immediately if any of the following occur:
Prenehajte z jemanjem zdravila Exviera in se pogovorite z zdravnikom ali si nemudoma priskrbite zdravniško pomoč, če se pojavi kaj od naslednjega: Neželeni učinki, ki se lahko pojavijo pri jemanju zdravila Exviera z ombitasvirjem/paritaprevirjem/ritonavirjem z ali brez ribavirina:
Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Skupina B: dasabuvir in ombitasvir/paritaprevir/ritonavir
Genotype 1a, without cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
genotip 1a, brez ciroze dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin
Mechanism: OATP1B1 inhibition by paritaprevir.
OATP1B1 s paritaprevirjem.
Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
Skupina A: dasabuvir in ombitasvir/paritaprevir/ritonavir + RBV (12 tednov)
Trial
Preskušanje
St. John's Wort (hypericum perforatum)
ZDRAVILA RASTLINSKEGA IZVORA šentjanževka (hypericum perforatum)
Mechanism: CYP3A4 inhibition by ritonavir.
Učinek na sirolimus je posledica CYP3A4 inhibicije z ritonavirjem.
↔ nor ethindrone
↔ tenofovir
SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
Preglednica 7: SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1, v preskušanju SAPPHIRE-I
IMMUNOSUPPRESSANTS Ciclosporin
ANTIDEPRESIVI escitalopram
Refer to the Summary of Product Characteristics for ribavirin for additional information.
Za dodatne informacije glejte povzetek glavnih značilnosti zdravila za ribavirin.
See Table 2 for guidance regarding potential drug interactions and dosing recommendations for dasabuvir administered with ombitasvir/paritaprevir/ritonavir.
Za smernice o možnih medsebojnih delovanjih zdravil in priporočila za odmerjanje dasabuvirja, uporabljenega s kombinacijo ombitasvir/paritaprevir/ritonavir, glejte preglednico 2.
IRON CHELATORS Deferasirox dasabu vir + ombitas vir/parit aprevir/ ritonavi r
KELATORJI ŽELEZA deferasiroks dasabuvir ombitasvir/ paritaprevi r/ritonavir
For contra-indications with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Za kontraindikacije s kombinacijo ombitasvir/paritaprevir/ritonavir glejte povzetek glavnih značilnosti zdravila za ombitasvir/paritaprevir/ritonavir.
dasabuvir and ombitasvir/paritaprevir/ritonavir for 8 weeks Treated subjects (N=166) had a median age of 53 years (range: 22 to 82); 56.6% were female; 3.0% were Asian; 0.6% were Black; 7.2% had baseline HCV RNA levels of at least 6,000,000 IU per mL;
Zdravljeni preiskovanci (N=166) so bili mediano stari 53 let (razpon: od 22 do 82); 56,6 % je bilo žensk; 3,0 % je bilo Azijcev; 0,6 % je bilo črncev; 7,2 % jih je imelo izhodiščno koncentracijo HCV
They are always taken with another antiviral medicine containing ombitasvir/paritaprevir/ritonavir.
Vedno se jemljejo skupaj z drugim protivirusnim zdravilom, ki vsebuje kombinacijo ombitasvirja/paritaprevirja/ritonavirja.
Hepatic impairment
DIURETIKI furosemid
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Cyclobenzap rine 5 mg single dose
dasabuvir ombitasvir paritaprevir sirolimus 0,5 mg enkratni odmerek5
Lansoprazole Mechanism: CYP2C19 induction by ritonavir.
↔ dasabuvir ↔ ombitasvir ↔ paritaprevir esomeprazol lansoprazol Mehanizem: Indukcija CYP2C19 z ritonavirjem.
Dose normalized cyclosporine ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Za odmerek normalizirana razmerja ciklosporina so prikazana za medsebojno delovanje z dasabuvirjem + kombinacijo ombitasvir/paritaprevir/ritonavir.
buprenorphin e/ naloxone 4-24 mg/16 mg once daily8
4-24 mg/1-6 mg enkrat na dan8
Interactions between dasabuvir with ombitasvir/paritaprevir/ritonavir and other medicinal products
Preglednica 2: Medsebojna delovanja z drugimi zdravili med uporabo dasabuvirja s kombinacijo ombitasvir/paritaprevir/ritonavir
Use with statins
Uporaba s statini Rosuvastatin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when dasabuvir is used with ribavirin.
Če je dasabuvir uporabljen z ribavirinom, je potrebna skrajna previdnost, da bi preprečili nosečnost bolnic in partnerk bolnikov.
Ciclosporin 100 mg dosed alone and 30 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Ciklosporin 100 mg, uporabljen sam, ali 30 mg skupaj z dasabuvirjem + kombinacijo ombitasvir/paritaprevir/ritonavir.
Atazanavir/ ritonavir 300/100 mg once daily
AUC Ctrough Klinične opombe atazanavir 300 mg enkrat na dan (dan ob istem času)
MEDICINAL PRODUCTS USED IN MULTIPLE SCLEROSIS Teriflunomid e dasabu vir +
ZDRAVILA, KI SE UPORABLJAJO PRI ZDRAVLJENJU MULTIPLE SKLEROZE teriflunomid dasabuvir ombitasvir/ paritaprevi r/ritonavir
↑ norgestrel ↑ nor elgestromin e
norgestrel norelgestromi n dasabuvir
Reduce pravastatin dose by 50%.
NP Zmanjšajte odmerek pravastatina za
The effect on rilpivirine exposures was similar to that observed when rilpivirine was administered in the morning with food with dasabuvir + ombitasvir/paritaprevir/ritonavir.
če je bil rilpivirin uporabljen zjutraj s hrano z dasabuvirjem + kombinacijo ombitasvir/paritaprevir/ritonavir.
Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks With RBV
Izid zdravljenja dasabuvir in ombitasvir/paritaprevir/ritonavir 12 tednov Z RBV
Transient elevations in total bilirubin >3 x ULN (mostly indirect) occurred in 17 (27.0%) subjects; 15 of these subjects were receiving atazanavir.
Bolniki, sočasno okuženi s HIV in HCV Celotne varnostne značilnosti pri preiskovancih sočasno okuženih s HCV in HIV-1 so bile podobne kot so jih opažali pri preiskovancih, okuženih samo s HCV. Prehodna zvišanja celokupnega bilirubina (v glavnem indirektnega) na > 3-kratno ZNM so se pojavila pri 17 (27,0 %) preiskovancih; 15 teh preiskovancev je prejemalo atazanavir.
Efavirenz/ emtricitabine / tenofovir disoproxil fumarate mg once daily
efavirenz/emtricit abin/tenofovirijev dizoproksilfumar at
No dose adjustment is necessary for emtricitabine/tenofovir and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Prilagoditev odmerka ni potrebna za emtricitabin/tenof ovir in kombinacijo dasabuvir + ombitasvir/paritap revir/ritonavir.
Pravastatin 10 mg once daily
10 mg enkrat na dan
Mechanism: CYP2C19 induction by ritonavir dasabu vir +
Mehanizem: Indukcija CYP2C19 z ritonavirjem dasabuvir ombitasvir/ paritaprevi r/ritonavir
to thin the blood
(ODGOVORNI) ZA SPROŠČANJE SERIJ
Treatment duration 12 weeks
Trajanje zdravljenja
Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with dasabuvir.
uporabljenih v kombinaciji z dasabuvirjem.
Duloxetine 60 mg single dose dasabu vir + ombitas vir/parit aprevir/ ritonavi r duloxetine
dasabuvir ombitasvir paritaprevir duloksetin Posamezen odmerek 60 mg dasabuvir ombitasvir/ paritaprevi r/ritonavir duloksetin
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; 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; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Zdravljeni preiskovanci (N = 380) so bili mediano stari 58 let (razpon: od 21 do 71); 42,1 % jih še ni bilo zdravljenih, 36,1 % jih predhodno ni imelo odziva na pegIFN/RBV; 8,2 % jih je predhodno imelo delen odziv na pegIFN/RBV in 13,7 % jih je predhodno imelo recidiv ob pegIFN/RBV; 70,3 % je bilo moških; 3,2 % je bilo črncev; 14,7 % jih je imelo število trombocitov manj kot 90 x 109/l; 49,7 % jih je imelo albumin manj kot 40 g/l; 86,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj
Refer to the Summary of Product Characteristics of ombitasvir/paritaprevir/ritonavir for its pharmacological properties.
Za njegove farmakološke lastnosti glejte povzetek glavnih značilnosti zdravila za ombitasvir/paritaprevir/ritonavir.
No dose adjustment of dasabuvir is required for patients with mild, moderate, or severe renal impairment or end-stage-renal disease on dialysis (see section 5.2).
Bolnikom z blago, zmerno ali hudo okvaro ledvic ali bolnikom s končno ledvično odpovedjo, ki so na dializi, odmerkov dasabuvirja ni treba prilagoditi (glejte poglavje 5.2).
No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and one subject with HCV genotype 1b infection experienced relapse.
Virusna neodzivnost med zdravljenjem se ni pojavila pri nobenem preiskovancu, okuženem s HCV genotipa 1b, recidiv pa se je pojavil pri enem takšnem preiskovancu.
The SVR12 rates in HCV/HIV-1 co-infected subjects were thus consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Deleži SVR12 pri preiskovancih, sočasno okuženih s HCV/HIV-1, so se skladali z deleži SVR12,
Dose normalized tacrolimus ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Za odmerek normalizirana razmerja takrolimusa so prikazana za medsebojno delovanje z dasabuvirjem + kombinacijo ombitasvir/paritaprevir/ritonavir.
NA No dose adjustment required for diazepam; increase dose if clinically indicated.
povečajte odmerek, če je klinično indicirano.
Caution should be used when sulfasalazine is co-administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Previdnost je potrebna, ko se sulfasalazin daje sočasno z dasabuvirjem + ombitasvir/paritap revir/ritonavir.
SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
Preglednica 8: SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1b, v preskušanju PEARL III
CYP3A4 inhibition by ritonavir.
Zavrtje CYP3A4 z ritonavirjem.
SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV
Preglednica 9: SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1a, v preskušanju PEARL IV
No dose adjustment is necessary for norethindrone or dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Prilagoditev odmerka ni potrebna za noretindron ali kombinacijo dasabuvir + ombitasvir/paritap revir/ritonavir
• If you get any side effects, talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Zavrtje UGT1A1 s paritaprevirjem, ombitasvirjem in dasabuvirjem.
• Serious allergic reactions, signs may include: o Difficulty breathing or swallowing o Dizziness or light-headedness, which may be due to low blood pressure o Swelling of the face, lips, tongue or throat o Rash and itching of the skin
• vrtoglavica ali omotica, ki je lahko posledica nizkega krvnega tlaka
Medicinal products that inhibit CYP2C8
Možnost vpliva drugih zdravil na farmakokinetiko dasabuvirja Zdravila, ki zavirajo CYP2C8
Metabolism and nutrition disorders Uncommon Dehydration Psychiatric disorders Very common Insomnia Gastrointestinal disorders Very common Nausea, Diarrhoea Common
Neznana pogostnost dekompenzacija jeter in okvara jeter dekompenzacija jeter in okvara jeter Bolezni kože in podkožja
Pooled efficacy analysis
UČINKOVITO UPORABO ZDRAVILA
Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV 12 weeks
Izid zdravljenja dasabuvir in ombitasvir/paritaprevir/ritonavir z RBV 12 tednov
Breastfeeding
amlodipin
Atazanavir must be administered at dasabuvir ombitasvir
↔ atazanavir dasabuvir
Concomitant use of tacrolimus with dasabuvir and ombitasvir/paritaprevir/ ritonavir is not recommended unless the benefits outweigh dasabuvir ombitasvir
Sočasna uporaba sirolimusa z dasabuvirjem + kombinacijo ombitasvir/paritap revir/ritonavir ni priporočljiva,
dasabuvir and ombitasvir/paritaprevir/ritonavir without ribavirin or with weight-based ribavirin for 12 weeks
Zdravljenje: dasabuvir in ombitasvir/paritaprevir/ritonavir brez ribavirina ali z ribavirinom, odmerjenim glede na telesno maso, 12 tednov
Methadone
↓ metformin
NA Concomitant use is contraindicated (see the Summary of Product Characteristics for
Sočasna uporaba je kontraindicirana (glejte poglavje imatinib
300 mg single dose itonavir ombitasvir/paritaprevir/ ritonavir.
Posamezni odmerek 300 mg dasabuvir ombitasvir/ paritaprevi r/ ritonavir paracetamol
Rare
Recidiv
A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with ombitasvir/paritaprevir/ritonavir.
V času zdravljenja s kombinacijo ombitasvir/paritaprevir/ritonavir je priporočljivo začasno opustiti suspenzijo pitavastatina/fluvastatina.
dasabuvir and ombitasvir/paritaprevir/ritonavir with weight-based ribavirin for 12 or 24 weeks
Zdravljenje: dasabuvir in ombitasvir/paritaprevir/ritonavir z ribavirinom, odmerjenim glede na telesno maso, 12 ali 24 tednov
Mechanism: CYP3A4 induction by carbamazepi ne.
Mehanizem: Indukcija CYP3A4 s šentjanževko.
For interactions with ombitasvir/ paritaprevir /ritonavir refer to the Summary of Product Characteristics.
Za interakcije z ombitasvirjem/paritaprevirjem/ritonavirjem glejte povzetek glavnih značilnosti zdravila.
Skin and subcutaneous tissue disorders Very common Pruritus Common
Splošne težave in spremembe na mestu aplikacije Zelo pogosti astenija utrujenost
Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser Outcome for subjects without SVR12 On-treatment VF
Celotni SVR12 HCV genotip 1a Predhodno brez odziva na pegIFN/RBV Predhodno delen odziv na pegIFN/RBV Predhodno recidiv ob pegIFN/RBV HCV genotip 1b Predhodno brez odziva na pegIFN/RBV Predhodno delen odziv na pegIFN/RBV Predhodno recidiv ob pegIFN/RBV Izid pri preiskovancih brez SVR12 VN med zdravljenjem Recidiv Drugo
Mechanism: CYP3A inhibition by ritonavir.
Zavrtje CYP3A z ritonavirjem.
No increase in incidence of ALT elevations was observed with other types of systemic oestrogens commonly used for hormone replacement therapy (e.g., oestradiol and conjugated oestrogens).
Z drugimi vrstami sistemskih 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, so se po navadi pojavila v prvih 4 tednih zdravljenja (povprečni čas 20 dni, razpon od
Dasabuvir is administered with ombitasvir/paritaprevir/ritonavir.
Dasabuvir se uporablja s kombinacijo ombitasvir/paritaprevir/ritonavir.
paritaprevir the same time as dasabuvir +ombitasvir/paritaprevi r/ritonavir.
Mehanizem: ni znan dasabuvir ombitasvir/ paritaprevi r/ritonavir.
dasabuvir and ombitasvir/paritaprevir /ritonavir
dasabuvir in ombitasvir/paritaprevir/ritonavir
dasabuvir and ombitasvir/paritaprevir/ritonavir
dasabuvir in ombitasvir/paritaprevir /ritonavir