FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2).
Slovenian: Starejšim bolnikom odmerkov zdravila Viekirax ni treba prilagoditi (glejte poglavje 5.2).
English: 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.
Slovenian: 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
English: Adverse drug reactions identified with Viekirax in combination with dasabuvir with and without ribavirin
Slovenian: Neželeni učinki zdravila ugotovljeni z zdravilom Viekirax v kombinaciji z dasabuvirjem ter z ribavirinom ali brez njega
English: Ombitasvir, paritaprevir and ritonavir were absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Slovenian: Absorpcija Ombitasvir, paritaprevir in ritonavir so se po peroralni uporabi absorbirali s povprečnim tmax približno 4
English: AbbVie Deutschland GmbH & Co. KG Knollstrasse,
Slovenian: AbbVie Deutschland GmbH & Co.
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine +/- naloxone (N=19) received 12 weeks of Viekirax and dasabuvir with ribavirin.
Slovenian: 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.
English: Expected: ↑ ticagrelor
Slovenian: Pričakovano: ↑ ticagrelor
English: Examples of other CYP3A4 substrates which may require dose adjustment and/or clinical monitoring include calcium channel blockers (e.g. nifedipine), and trazodone.
Slovenian: Med primeri drugih substratov CYP3A4, pri katerih je lahko potrebna prilagoditev odmerka, klinično spremljanje ali oboje, so zaviralci kalcijevih kanalčkov
English: Table 14.
Slovenian: Preglednica 14.
English: Not applicable.
Slovenian: njega ni potrebna.
English: Similar effect expected as observed with Viekirax + dasabuvir.
Slovenian: Pričakovan podoben učinek kot s kombinacijo Viekirax + dasabuvir.
English: 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)
Slovenian: 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
English: 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.
Slovenian: 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.
English: SAPPHIRE-II - genotype 1, pegIFN+RBV-experienced, without cirrhosis
Slovenian: SAPPHIRE-II - genotip 1, že zdravljeni s pegIFN + RBV, brez ciroze
English: Following a single 25 mg dose of 14C- ombitasvir approximately 90% of the radioactivity was recovered in faeces and 2% in urine.
Slovenian: 14C-ombitasvirja se je približno 90 % radioaktivnosti pojavilo v blatu in 2 % v urinu.
English: CYP3A4 induction by phenobarbital.
Slovenian: Indukcija CYP3A4 s fenobarbitalom
English: 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.
Slovenian: 400 mg (s 100 mg ritonavirja), za ritonavir 200 mg (s 100 mg paritaprevirja) in za ombitasvir 350 mg. S
English: Alprazolam 0.5 mg single dose
Slovenian: alprazolam enkraten odmerek 0,5 mg
English: Clinical efficacy and safety
Slovenian: Zdravilo ali zdravilna učinkovina
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Psychiatric disorders Very common
Slovenian: Bolezni prebavil Zelo pogosti navzea
English: ANTICANCER AGENTS Enzalutamide
Slovenian: ZDRAVILA PROTI RAKU enzalutamid mitotan
English: Marketing Authorisation Holder AbbVie Ltd
Slovenian: Imetnik dovoljenja za promet z zdravilom AbbVie Ltd
English: Mechanism: CYP3A4 induction enzalutamide or mitotane.
Slovenian: Indukcija CYP3A4 z enzalutamidom ali mitotanom
English: Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Slovenian: Mehanizem: Indukcija CYP2C19 in indukcija CYP3A4 z ritonavirjem
English: Mechanism: CYP3A4 induction by carbamazepine
Slovenian: Mehanizem: Indukcija CYP3A4 s karbamazepino m
English: ↑ voriconazole
Slovenian: ↑ vorikonazol
English: 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)
Slovenian: 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)
English: S-warfarin paritaprevir ombitasvir
Slovenian: S-varfarin paritaprevir ombitasvir dabigatran eteksilat
English: randomised, global multicentre, open-label
Slovenian: Oblika preskušanja: randomizirano, globalno, multicentrično, odprto
English: 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.
Slovenian: 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,
English: 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.
Slovenian: Sočasna uporaba zdravila Viekirax z dasabuvirjem združuje tri direktno delujoča protivirusna zdravila z različnimi mehanizmi delovanja.
English: SVR12 for genotype 4-infected, subjects who were treatment-naïve or previously treated with pegIFN/RBV in PEARL I
Slovenian: SVR12 pri še nezdravljenih preiskovancih ali takih, ki so bili predhodno zdravljeni s pegIFN/RBV, okuženih z genotipom 4, v preskušanju PEARL I
English: SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Slovenian: SVR12 pri preiskovancih, že zdravljenih s peginterferonom + ribavirinom, okuženih z genotipom 1b, v preskušanju PEARL II
English: Side effects when taking Viekirax with dasabuvir and ribavirin:
Slovenian: Neželeni učinki pri jemanju zdravila Viekirax dz asabuvirjem in ribavirinom:
English: 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.
Slovenian: OATP1B1/B3 in CYP3A z atazanavirjem ter CYP3A z dodatnim odmerkom ritonavirja.
English: Mechanism: CYP3A4 induction by rifampicin.
Slovenian: Mehanizem: Indukcija CYP3A4 z rifampicinom
English: (0.81-0.96) (0.88-1.02) monitoring of INR is recommended with all vitamin K antagonists.
Slovenian: (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.
English: 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).
Slovenian: Viekirax z zdravili, ki so zmerni zaviralci CYP3A4 in zaviralci več prenašalcev (P-gp, BCRP in/ali
English: Viekirax and dasabuvir with RBV Arm A 12 Weeks N = 31
Slovenian: Viekirax in dasabuvir z RBV Skupina A 12 tednov N = 31
English: Mechanism: OATP1B1 inhibition by paritaprevir.
Slovenian: OATP1B1 z paritaprevirjem
English: Viekirax and dasabuvir with investigator chosen ribavirin dose for 24 weeks
Slovenian: Zdravljenje: Viekirax in dasabuvir z odmerkom ribavirina, ki ga izbere raziskovalec, 24 tednov
English: TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Slovenian: TURQUOISE-II - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s kompenzirano cirozo
English: Viekirax + dasabuvir atazanavir
Slovenian: Viekirax + ↔ atazanavir
English: Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir.
Slovenian: CYP3A4/P-gp z eritromicinom, paritaprevirjem, ritonavirjem in dasabuvirjem
English: Hepatobiliary Disorders: Hepatic decompensation, hepatic failure have been observed during treatment with Viekirax with and without dasabuvir and with or without ribavirin (see section 4.4).
Slovenian: Bolezni jeter, žolčnika in žolčevodov: med zdravljenjem z zdravilom Viekirax z ali brez dasabuvirja in z ali brez ribavirina so opazili dekompenzacijo jeter in okvaro jeter (glejte poglavje 4.4).
English: Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/ paracetamol or diazepam.
Slovenian: (uporaba zvečer), rilpivirinom, abakavir/lamivudinom, dolutegravirjem, metforminom, sulfametoksazol/trimetoprimom, ciklobenzaprinom, karisoprodolom, hidrokodon/paracetamolom ali diazepamom.
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Slovenian: Zdravljenje: Viekirax in dasabuvir brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov Zdravljeni preiskovanci (N = 305) so bili mediano stari 54 let (razpon: od 19 do 70); 65,2 % je bilo moških; 11,8 % je bilo črncev; 20,7 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 86,6 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 18,4 % jih je imelo portalno fibrozo (F2) in 17,7 % jih je imelo fibrozo z mostiči (F3).
English: Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovenian: CYP3A4 z ritonavirjem in zavrtje UGT s paritaprevirjem, ombitasvirjem in dasabuvirjem.
English: HERBAL PRODUCTS St. John's Wort (hypericum perforatum)
Slovenian: ZDRAVILA RASTLINSKEGA IZVORA šentjanževka (Hypericum perforatum)
English: ANTIHISTAMINES Astemizole
Slovenian: ANTIHISTAMINIKI astemizol terfenadin
English: Expected: ↓ esomeprazole, lansoprazole
Slovenian: ↓ esomeprazol, lansoprazol
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Slovenian: Zdravljeni preiskovanci (N = 631) so bili mediano stari 52 let (razpon: od 18 do 70); 54,5 % je bilo moških; 5,4 % je bilo črncev; 15,2 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 79,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 15,4 % jih je imelo portalno fibrozo (F2) in 8,7 % jih je imelo fibrozo z mostiči (F3); 67,7 % jih je imelo okužbo s HCV genotipa 1a; 32,3 % jih je imelo okužbo s HCV genotipa 1b.
English: Mechanism: CYP3A4/Pgp inhibition by clarithromyci n and ritonavir.
Slovenian: CYP3A4/P-gp s klaritromicinom in ritonavirjem
English: Selected treatment emergent laboratory abnormalities
Slovenian: Izbrane laboratorijske nepravilnosti, ki so se pojavile med zdravljenjem
English: Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir
Slovenian: Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete ombitasvir/paritaprevir /ritonavir
English: Pitavastatin Mechanism: OATP1B inhibition by paritaprevir
Slovenian: OATP1B s paritaprevirjem
English: Viekirax without dasabuvir duloxetine
Slovenian: Viekirax brez dasabuvirja duloksetin
English: 500 mg single dose
Slovenian: 500 mg
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
Slovenian: CYP3A4/P-gp s ketokonazolom in paritaprevirjem/ ritonavirjem/om bitasvirjem
English: No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and 2 subjects with HCV genotype 1b infection experienced relapse.
Slovenian: Virološki neuspeh med zdravljenjem se ni pojavil pri nobenem preiskovancu, okuženem s HCV genotipa 1b, recidiv pa se je pojavil pri 2 takšnih preiskovancih.
English: 2 mg single dose
Slovenian: Posamezen odmerek 2 mg
English: No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and one subject with HCV genotype 1b infection experienced relapse.
Slovenian: Virološki neuspeh med zdravljenjem se ni pojavil pri nobenem preiskovancu, okuženem s HCV genotipa 1b, recidiv pa se je pojavil pri enem takšnem preiskovancu.
English: SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
Slovenian: SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1, v preskušanju SAPPHIRE-I
English: Viekirax and dasabuvir with weight-based ribavirin for 12 or 24 weeks
Slovenian: Zdravljenje: Viekirax in dasabuvir z ribavirinom, odvisnim od telesne mase, 12 ali 24 tednov
English: Anaemia
Slovenian: AMINOSALICILATI
English: No dose adjustment is necessary for emtricitabine/tenofovir and Viekirax with or without dasabuvir.
Slovenian: Prilagoditev odmerka emtricitabina/tenofov irja in zdravila Viekirax z dasabuvirjem ali brez njega ni potrebna.
English: NA Reduce pravastatin dose by
Slovenian: Prilagoditev odmerka dolutegravirja ni
English: ANTIPSYCHOTICS Lurasidone
Slovenian: ANTIPSIHOTIKI lurasidon pimozid kvetiapin
English: Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovenian: UGT1A1 s paritaprevirjem, ombitasvirjem in dasabuvirjem
English: GT1a Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Peginterferon+ribavirin experienced -, without cirrhosis
Slovenian: GT1a Skupina A: Viekirax in dasabuvir+ RBV Skupina B: Viekirax in dasabuvir Že zdravljeni s peginterferonom + ribavirinom, brez ciroze
English: ↑ naloxone
Slovenian: ↑ dronedaron
English: Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate mg once daily
Slovenian: efavirenz/emtri citabin/dizopro ksiltenofovirat fumarat 600/300/200 m g enkrat na dan
English: CYP3A4/Pgp inhibition.
Slovenian: CYP3A4/P-gp
English: Viekirax with weight-based ribavirin for 12 or 16 weeks Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL.
Slovenian: Preiskovanci so bili mediano stari 56 let (razpon: 32 do 81); 50 % jih še ni bilo zdravljenih, 28 % se jih predhodno ni odzvalo na pegIFN/RBV; 10 % se jih je predhodno delno odzvalo na pegIFN/RBV, 13 % se je predhodno pojavil recidiv s pegIFN/RBV; 70 % je bilo moških; 17 % je bilo črncev; 73 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i.e./ml; 17 % jih je imelo število trombocitov manj kot 90 x 109/l; in 4 % jih je imelo albumin manj kot 3,5 mg/dl.
English: Viekirax + dasabuvir alprazolam
Slovenian: Viekirax + dasabuvir escitalopram
English: Mechanism: CYP3A4 induction by phenytoin.
Slovenian: Mehanizem: Indukcija CYP3A4 s fenitoinom
English: Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
Slovenian: CYP3A4 in/ali P-gp z itrakonazolom, posakonazolom in paritaprevirjem/ ritonavirjem/om bitasvirjem
English: ↓ voriconazole ↑ paritaprevir
Slovenian: ↓ vorikonazol ↑ paritaprevir
English: Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL
Slovenian: Celotni SVR12 HCV genotip 1a HCV genotip 1b Izid pri preiskovancih brez SVR12 VN med zdravljenjema Recidiv Drugo b 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.
English: Following a 25 mg single dose of 14C-ombitasvir given alone, unchanged parent drug accounted for 8.9% of total radioactivity in human plasma; a total of 13 metabolites were identified in human plasma.
Slovenian: Po 25-mg enkratnem odmerku 14C-ombitasvirja, uporabljenega samega, je šlo na račun nespremenjenega matičnega zdravila 8,9 %
English: One subject with HCV genotype 1a infection relapsed post-treatment.
Slovenian: Recidiv po zdravljenju se je pojavil enemu preiskovancu, okuženem s HCV genotipa 1a.
English: SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
Slovenian: SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1b, v preskušanju PEARL III
English: NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir
Slovenian: Navodilo za uporabo Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete ombitasvir/paritaprevir/ritonavir
English: In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Slovenian: V študiji TURQUOISE-I so se deleži SVR12 pri preiskovancih, sočasno okuženih s HCV/HIV-1, skladali z deleži SVR12, ugotovljenimi v preskušanjih 3. faze pri preiskovancih, okuženih samo s HCV. SVR12 je doseglo 7 od 7 preiskovancev, okuženih z genotipom 1b, in 51 od 56 preiskovancev, okuženih z genotipom 1a.
English: Ciclosporin
Slovenian: ↑ ciklosporin
English: ↑ quetiapine ↑ lurasidone
Slovenian: ↑ kvetiapin ↑ lurasidon
English: CYP3A4 inhibition by ritonavir.
Slovenian: Zavrtje CYP3A4 z ritonavirjem
English: Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter (Child-Pugh C) je zdravilo Viekirax kontraindicirano (glejte poglavji 4.3 in 5.2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Slovenian: Ena filmsko obložena tableta vsebuje 12,5 mg ombitasvirja, 75 mg paritaprevirja in 50 mg ritonavirja.
English: Mechanism: CYP3A4 inhibition by ritonavir
Slovenian: Mehanizem: Zavrtje CYP3A4 z ritonavirjem
English: Clinical trials in subjects with genotype 4 chronic hepatitis C PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis Design:
Slovenian: PEARL- I- genotip 4, še nezdravljeni ali že zdravljeni s kombinacijo pegIFN + RBV, brez ciroze
English: Expected: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir
Slovenian: Pričakovano: ↓ dasabuvir ↓ ombitasvir ↓ paritaprevir
English: The pharmacokinetic properties of the combination of Viekirax with dasabuvir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 19 shows mean Cmax and AUC of Viekirax 25 mg/150 mg/100 mg once daily with dasabuvir 250 mg twice daily following multiple doses with food in healthy volunteers.
Slovenian: Farmakokinetične lastnosti kombinacije zdravila Viekirax in dasabuvirja so ocenili pri zdravih odraslih in pri bolnikih s kroničnim hepatitisom C. Preglednica 18 prikazuje povprečni Cmax in AUC za zdravilo