natgillin/translations-raw huggingface dataset:
Medicines you must not take with Viekirax Medicine or active substance
Zdravila, ki jih ne smete jemati z zdravilom Viekirax Zdravilo ali zdravilna učinkovina
Phase 3 global multicentre studies conducted with Viekirax and dasabuvir with or without ribavirin (RBV).
Globalne multicentrične študije 3. faze z zdravilom Viekirax in dasabuvirjem, z ribavirinom (RBV) ali brez njega.
20-120 mg once daily
20-120 mg enkrat na dan
Table 3 lists adverse reactions for which a causal relationship between paritaprevir/ombitasvir/ritonavir, in combination with dasabuvir and/or ribavirin, and the adverse event is at least a reasonable possibility.
Seznam neželenih učinkov v preglednici Preglednica 3 navaja neželene učinke, za katere je vzročna povezanost med kombinacijo paritaprevir/ombitasvir/ritonavir skupaj z dasabuvirjem in/ali ribavirinom ter neželenim učinkom vsaj upravičeno možna.
Monitor tacrolimus levels and adjust dose and/or dosing frequency as needed.
Kontrolirajte koncentracijo takrolimusa in prilagodite odmerek in/ali pogostnost uporabe, kot je potrebno.
CONTRACEPTIVES Ethinylestradiol/ norgestimate
KONTRACEPTIVI etinilestradiol/n orgestimat
Mechanism: decrease possibly due to CYP1A2 induction by ritonavir
Mehanizem: Možno zmanjšanje zaradi zavrtja CYP1A2 z ritonavirjem
The safety profile of Viekirax and dasabuvir was similar in subjects without cirrhosis, and with compensated cirrhosis with the exception of increased rates of transient hyperbilirubinemia when ribavirin was part of the regimen.
Varnostne značilnosti zdravila Viekirax in dasabuvirja so bile podobne pri preiskovancih brez ciroze in pri tistih s kompenzirano cirozo, z izjemo večjega deleža prehodne hiperbilirubinemije ob jemanju z ribavirinom.
↑ quinidine ↑ ranolazine
↑ kinidin ↑ ranolazin
− Tablet core: copovidone, vitamin E polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E551), sodium stearyl fumarate.
− Jedro tablete: kopovidon, vitamin E, poletilenglikol sukcinat, propilenglikol monolavrat, sorbitan monolavrat, koloidni brezvodni silicijev dioksid (E551), natrijev stearilfumarat.
In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1).
V študiji po presaditvi jeter je bilo odmerjanje ribavirina individualizirano in večina preiskovancev ga je prejemala od 600 do 800 mg na dan
Interactions between Viekirax with or without dasabuvir and other medicinal products
Interakcije med zdravilom Viekirax (z dasabuvirjem ali brez njega) in drugimi zdravili
D168Y V36Ac, V36Mc, F43Lc, D168H, E357Kc NS5A M28T M28Ve Q30Re Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Observed in at least 2 subjects of the same subtype.
Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Opažene pri vsaj 2 preiskovancih istega podtipa.
What Viekirax looks like and contents of the pack Viekirax tablets are pink, oblong film-coated tablets of dimmensions 18.8 mm x 10.0 mm, marked with ‘AV1'.
Tablete zdravila Viekirax so rožnate, podolgovate, filmsko obložene tablete velikosti 18,8 mm x 10,0 mm, z oznako "AV1".
It contains the active substances ombitasvir, paritaprevir and ritonavir.
Zdravilo vsebuje zdravilne učinkovine ombitasvir, paritaprevir in ritonavir.
The majority of adverse reactions presented in Table 3 were of grade 1 severity in Viekirax and dasabuvircontaining regimens.
Večina neželenih učinkov, predstavljenih v preglednici 3, je bila v shemah, ki so vključevale zdravilo Viekirax in dasabuvir, 1. stopnje glede na resnost.
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
Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim
Mehanizem: Možno povečanje dasabuvirja zaradi zavrtja CYP2C8 s trimetoprimom
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.
Clinical studies in subjects with genotype 1 hepatitis C infection
Klinična učinkovitost in varnost Klinične študije pri preiskovancih, okuženih s hepatitisom C genotipa 1
Table 18.
Preglednica 18.
AMINOSALICYLATE Sulfasalazine
Klinične opombe sulfasalazin
ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4)
ALT > 5-20 × ZNM*
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu
↑ telithromycin ↑ paritaprevir
↑ dasabuvir ↑ paritaprevir
In a pooled analysis of clinical trials with Viekirax and dasabuvir with and without ribavirin, 1% of subjects experienced serum ALT levels greater than 5 times the upper limit of normal (ULN) after starting treatment.
V kumulativni analizi kliničnih preskušanj zdravila Viekirax in dasabuvirja, z ribavirinom ali brez njega, se je zvišanje ALT v serumu nad 5-kratno zgornjo normalno mejo (ZNM) po začetku zdravljenja pojavilo pri 1 % preiskovancev.
What Viekirax contains
Kaj vsebuje zdravilo Viekirax
Relapse rates in GT1a cirrhotic subjects by baseline laboratory values are presented in Table 13.
Deleži recidivov pri preiskovancih z GT1a in cirozo so predstavljeni v preglednici 13 glede na izhodiščne laboratorijske vrednosti.
Table 16.
Preglednica 16.
56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
56 tablet (večkratno pakiranje, ki vsebuje 4 škatle, vsaka s po 14 tabletami).
Table 17.
Preglednica 17.
Vitamin E polyethylene glycol succinate Propylene glycol monolaurate Sorbitan monolaurate Colloidal anhydrous silica (E551) Sodium stearyl fumarate
Jedro tablete kopovidon vitamin E poletilenglikol sukcinat propilenglikol monolavrat sorbitan monolavrat koloidni brezvodni silicijev dioksid (E551) natrijev stearilfumarat
SVR12 for HIV-1 co-infected Subjects in TURQUOISE-I
SVR12 pri preiskovancih, sočasno okuženih s HIV-1, v študiji TURQUOISE-I
The safety and efficacy of Viekirax in children below 18 years have not been established.
Varnost in učinkovitost zdravila Viekirax nista bili ugotovljeni pri otrocih, mlajših od 18 let.
PHARMACEUTICAL FORM AND CONTENTS Multipack: 56 (4 packs of 14) film-coated tablets
Večkratno pakiranje: 56 (4 škatle po 14) filmsko obloženih tablet
Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinylestradiol.
Zaradi zvišanja ALT sta zdravilo Viekirax in dasabuvir prenehali uporabljati dve osebi; ena od njiju je dobivala etinilestradiol.
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 s stroji.
NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
IME ZDRAVILA Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
trombocite ≥ 90 x 109/l in albumin ≥ 35 g/l), so bili deleži recidiva, pri zdravljenih 12 tednov in zdravljenih 24 tednov, podobni.
Effect of paritaprevir/ritonavir on ombitasvir and dasabuvir
Vpliv paritaprevirja/ritonavirja na ombitasvir in dasabuvir
Table 15.
Preglednica 15.
Side effects when taking Viekirax with dasabuvir:
Neželeni učinki pri jemanju zdravila Viekirax z dasabuvirjem:
SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatmentnaïve or previously treated with pegIFN/RBV
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.
As liver function may change during treatment with Viekirax administered with or without dasabuvir, a close monitoring of International Normalised Ratio (INR) values is recommended.
Bolniki zdravljeni z antagonisti vitamina K Ker se delovanje jeter med zdravljenjem z zdravilom Viekirax ob jemanju z ali brez dasabuvirja lahko spremeni, je priporočljivo skrbno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR
Clinical trials in peginterferon+ribavirin-experienced adults
Klinična preskušanja pri odraslih, že zdravljenih s peginterferonom + ribavirinom
Talk to your doctor or pharmacist before taking Viekirax if you: - have liver disease other than hepatitis C;
Pred začetkom jemanja zdravila Viekirax se posvetujte z zdravnikom ali farmacevtom, če: - imate tudi bolezen jeter, ki ni hepatitis C; - imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal.
800/100 mg once daily
800/100 mg enkrat na dan
NAME OF THE MARKETING AUTHORISATION HOLDER AbbVie Ltd
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM AbbVie Ltd
Table 12.
Preglednica 12.
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)
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
TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HIV-1 co-infection, without cirrhosis or with compensated cirrhosis
TURQUOISE-I - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s sočasno okužbo s HIV-1, brez ciroze ali s kompenzirano cirozo
In patients with renal or hepatic impairment, use of colchicine with Viekirax with or without dasabuvir is contraindicated (see section 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).
The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Viekirax and dasabuvir with or without ribavirin.
Povzetek o varnosti temelji na kumulativnih podatkih kliničnih preskušanj 2. in 3. faze pri več kot 2.600
24 weeks (see section 5.1.)
(glejte poglavje 5.1).
See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Za priporočila o odmerjanju pri bolnikih, sočasno okuženih s HCV/HIV-1, glejte poglavje 4.2.
Table 13.
Preglednica 13.
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: 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
Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B) (see sections 4.4 and 4.8).
Uporaba zdravila Viekirax pri bolnikih z zmerno okvaro jeter (Child-Pugh B) se ne priporoča (glejte poglavji 4.4 in 4.8).
Ethinylestradiol-containing oral contraceptives are contraindicated (see section 4.3).
Peroralni kontraceptivi z etinilestradiolom so kontraindicirani (glejte poglavje 4.3).
Other a. These virologic failures appear to have resulted from reinfection based on analyses of baseline and virologic failure samples
Drugo a. Glede na analize izhodiščnih vzorcev in vzorcev ob virološkem neuspehu se zdi, da so bili ti virološki neuspehi posledica ponovne okužbe.
Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.3, 4.8 and
Zdravilo Viekirax je kontraindicirano pri bolnikih s hudo okvaro jeter (Child-Pugh C) (glejte poglavja 4.2, 4.8 in 5.2.).
Patients should be informed that fatigue has been reported during treatment with Viekirax in combination with dasabuvir and ribavirin (see section 4.8).
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Bolnikom je treba povedati, da je bila med zdravljenjem z zdravilom Viekirax v kombinaciji z dasabuvirjem in ribavirinom opisana utrujenost (glejte poglavje 4.8).
SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
SVR12 pri preiskovancih, že zdravljenih s peginterferonom + ribavirinom, okuženih z genotipom 1, v preskušanju SAPPHIRE-II
No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2).
Starejšim bolnikom odmerkov zdravila Viekirax ni treba prilagoditi (glejte poglavje 5.2).
In all seven trials, the Viekirax dose was 25 mg/150 mg/100 mg once daily and the dasabuvir dose was 250 mg twice daily.
V vseh sedmih 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
Adverse drug reactions identified with Viekirax in combination with dasabuvir with and without ribavirin
Neželeni učinki zdravila ugotovljeni z zdravilom Viekirax v kombinaciji z dasabuvirjem ter z ribavirinom ali brez njega
Ombitasvir, paritaprevir and ritonavir were absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Absorpcija Ombitasvir, paritaprevir in ritonavir so se po peroralni uporabi absorbirali s povprečnim tmax približno 4
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 +/- naloxone (N=19) received 12 weeks of Viekirax and dasabuvir with ribavirin.
že zdravljenih s pegIFN/RBV, brez ciroze, in okuženih z genotipom 1, ki so dobivali stabilne odmerke metadona (N = 19) ali buprenorfina, z naloksonom ali brez njega (N = 19), 12 tednov prejemalo zdravilo Viekirax in dasabuvir skupaj z ribavirinom.
Expected: ↑ ticagrelor
Pričakovano: ↑ ticagrelor
Examples of other CYP3A4 substrates which may require dose adjustment and/or clinical monitoring include calcium channel blockers (e.g. nifedipine), and trazodone.
Med primeri drugih substratov CYP3A4, pri katerih je lahko potrebna prilagoditev odmerka, klinično spremljanje ali oboje, so zaviralci kalcijevih kanalčkov
Table 14.
Preglednica 14.
Not applicable.
njega ni potrebna.
Similar effect expected as observed with Viekirax + dasabuvir.
Pričakovan podoben učinek kot s kombinacijo Viekirax + dasabuvir.
Alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, 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 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 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)
Alprazolam, diazepam pri tesnobi, napadih panike in težavah s spanjem ciklosporin, 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 furosemid pri prekomernem kopičenju tekočine v telesu hidrokodon proti bolečini levotiroksin pri težavah s ščitnico rilpivirin, darunavir, atazanavir pri okužbah z virusom HIV
Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 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.
Mediana starost zdravljenih preiskovancev (N = 63) je bila 51 let (razpon: od 31 do 69); 24 % preiskovancev je bilo črncev, 19 % preiskovancev je imelo kompenzirano cirozo, 67 % preiskovancev še ni bilo zdravljenih zaradi HCV, 33 % preiskovancev je doživelo neuspeh predhodnega zdravljenja s pegIFN/RBV, 89 % preiskovancev je imelo okužbo s HCV genotipa 1a.
SAPPHIRE-II - genotype 1, pegIFN+RBV-experienced, without cirrhosis
SAPPHIRE-II - genotip 1, že zdravljeni s pegIFN + RBV, brez ciroze
Following a single 25 mg dose of 14C- ombitasvir approximately 90% of the radioactivity was recovered in faeces and 2% in urine.
14C-ombitasvirja se je približno 90 % radioaktivnosti pojavilo v blatu in 2 % v urinu.
CYP3A4 induction by phenobarbital.
Indukcija CYP3A4 s fenobarbitalom
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.
400 mg (s 100 mg ritonavirja), za ritonavir 200 mg (s 100 mg paritaprevirja) in za ombitasvir 350 mg. S
Alprazolam 0.5 mg single dose
alprazolam enkraten odmerek 0,5 mg
Clinical efficacy and safety
Zdravilo ali zdravilna učinkovina
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.
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.
Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in 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 z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (ChildPugh C) okvaro jeter.
Psychiatric disorders Very common
Bolezni prebavil Zelo pogosti navzea
ANTICANCER AGENTS Enzalutamide
ZDRAVILA PROTI RAKU enzalutamid mitotan
Marketing Authorisation Holder AbbVie Ltd
Imetnik dovoljenja za promet z zdravilom AbbVie Ltd
Mechanism: CYP3A4 induction enzalutamide or mitotane.
Indukcija CYP3A4 z enzalutamidom ali mitotanom
Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Mehanizem: Indukcija CYP2C19 in indukcija CYP3A4 z ritonavirjem
Mechanism: CYP3A4 induction by carbamazepine
Mehanizem: Indukcija CYP3A4 s karbamazepino m
These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin to lower blood cholesterol carbamazepine, phenytoin, phenobarbital for epilepsy cisapride for relieving certain stomach problems clarithromycin, fusidic acid, rifampicin, telithromycin for bacterial infections colchicine in patients who have severe problems with their liver or kidneys for treating gout attacks conivaptan for making the sodium levels in the blood normal efavirenz, etravirine, lopinavir/ritonavir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat for HIV infection enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinylestradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception itraconozole, ketoconozole, posaconazole, voriconazole for fungal infections midazolam, triazolam (when taken by mouth) for anxiety or trouble sleeping mitotane for symptoms of malignant tumours of the adrenal glands pimozide, lurasidone for schizophrenia quetiapine for schizophrenia, bipolar disorder and major depressive disorder quinidine for abnormal heart rhythms or malaria ranolazine for chronic angina (chest pain)
enzalutamid pri raku prostate ergotamin, dihidroergotamin pri migrenskih glavobolih ergonovin, metilergometrin uporaba pri porodu zdravila, ki vsebujejo etinilestradiol, kot je večina kontracepcijskih tablet in vaginalnih obročkov, ki se uporabljajo kot kontracepcija kontracepcija itrakonazol, ketokonazol, posakonazol, vorikonazol pri glivičnih okužbah midazolam, triazolam (če se jemlje skozi usta) pri občutku tesnobe ali težavah s spanjem mitotan pri simptomih malignih tumorjev nadledvičnih žlez pimozid, lurasidon pri shizofreniji kvetiapin pri shizofreniji, bipolarni motnji in veliki depresivni motnji kinidin pri nerednem srčnem utripu ali malariji ranolazin pri kronični angini pektoris (bolečine v prsnem košu)
randomised, global multicentre, open-label
Oblika preskušanja: randomizirano, globalno, multicentrično, odprto
CYP3A substrates evaluated in drug interaction studies which may require dose adjustment and/or clinical monitoring include (see Table 2) cyclosporine, tacrolimus, amlodipine, rilpivirine and alprazolam.
Med substrati CYP3A, ki so bili ocenjeni v študijah medsebojnega delovanja zdravil in pri katerih je lahko potrebna prilagoditev odmerka, klinično spremljanje ali oboje (glejte preglednico 2) so ciklosporin,
Viekirax, when co-administered with dasabuvir, combines three direct-acting antiviral agents 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.
SVR12 for genotype 4-infected, subjects who were treatment-naïve or previously treated with pegIFN/RBV in PEARL I
SVR12 pri še nezdravljenih preiskovancih ali takih, ki so bili predhodno zdravljeni s pegIFN/RBV, okuženih z genotipom 4, v preskušanju PEARL I
SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
SVR12 pri preiskovancih, že zdravljenih s peginterferonom + ribavirinom, okuženih z genotipom 1b, v preskušanju PEARL II
Side effects when taking Viekirax with dasabuvir and ribavirin:
Neželeni učinki pri jemanju zdravila Viekirax dz asabuvirjem in ribavirinom:
Mechanism: Increase in paritaprevir exposures may be due to 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.
Mechanism: CYP3A4 induction by rifampicin.
Mehanizem: Indukcija CYP3A4 z rifampicinom
(0.81-0.96) (0.88-1.02) monitoring of INR is recommended with all vitamin K antagonists.
(0,84-0,99) (0,93-1,10) (0,81-1,01) atazanavirja je 300 mg brez ritonavirja, v kombinaciji z zdravilom Viekirax in dasabuvirjem.