FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment of Viekirax is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka Viekirax u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega, ili u bolesnika sa završnim stadijem bubrežne bolesti koji su na dijalizi (vidjeti dio 5.2).
English: The maximum daily dose of rosuvastatin should be 5 mg (see section 4.4).
Croatian: Najveća dnevna doza rosuvastatina smije biti 5 mg (vidjeti dio 4.4)
English: All treatment-emergent variants in NS5A remained detectable at post-treatment Week 48.
Croatian: Sve varijante u NS5A nastale tijekom liječenja bile su mjerljive u
English: Clinical trials in peginterferon+ribavirin-experienced adults
Croatian: Klinička ispitivanja u odraslih ispitanika prethodno liječenih peginterferonom i ribavirinom
English: Subjects with liver transplant and GT4 infection were dosed with Viekirax with RBV (non-cirrhotic for 12 weeks [n=2] and cirrhotic for 24 weeks [n=1].
Croatian: Ispitanici s jetrenim transplantatom i infekcijom genotipom 4 primali su Viekirax u kombinaciji s RBV-om (bolesnici bez ciroze tijekom 12 tjedana [n=2], a oni s cirozom tijekom 24 tjedna [n=1]).
English: Viekirax and dasabuvir with weight-based ribavirin for 12 weeks 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.
Croatian: Viekirax i dasabuvir tijekom 12 tjedana s ribavirinom čija je doza temeljena na težini Medijan dobi liječenih ispitanika (N=631) iznosio je 52 godine (raspon: 18 do 70); 54,5% bili su muškarci; 5,4% bili su crnci; 15,2% imalo je depresiju ili bipolarni poremećaj u anamnezi; 79,1% imalo je početne razine HCV RNK od najmanje 800 000 IU/ml; 15,4% imalo je portalnu fibrozu (F2), a 8,7% premoštavajuću fibrozu (F3); 67,7% imalo je infekciju HCV-om genotipa 1a; 32,3% imalo je infekciju HCV-om genotipa 1b.
English: 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.
Croatian: SVR-a (98,5%) bila je usporediva s onom postignutom u ispitanika koji su tijekom čitavog liječenja primali početnu dozu ribavirina.
English: Clinical Comments
Croatian: Kliničke napomene
English: Similarly, ombitasvir was not carcinogenic in a 2-year rat study up to the highest dose tested (30 mg per kg per day), resulting in ombitasvir exposures approximately 16-fold higher than those in humans at 25 mg.
Croatian: Slično tome, u 2-godišnjem istraživanju na štakorima ombitasvir nije bio kancerogen ni pri najvišoj ispitivanoj dozi (30 mg/kg/dan), koja je dovela do približno 16 puta veće izloženosti ombitasviru od izloženosti koja se postiže u ljudi nakon primjene doze od 25 mg.
English: Ombitasvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (150 mg/kg/day), resulting in ombitasvir AUC exposures approximately 26-fold higher than those in humans at the recommended clinical dose of 25 mg.
Croatian: 6-mjesečnom istraživanju na transgeničnim miševima, ombitasvir nije bio kancerogen ni pri najvišoj ispitivanoj dozi (150 mg/kg/dan), koja je dovela do približno 26 puta veće izloženosti ombitasviru (određene na temelju AUC-a) od izloženosti koja se postiže u ljudi nakon primjene preporučene kliničke doze od 25 mg.
English: Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
Croatian: Varijante V36A/M, R155K ili D168V u NS3 nastale tijekom primjene paritaprevira primijećene su u 47 ispitanika.
English: The safety of Viekirax in children and adolescents aged < 18 years has not yet been established.
Croatian: Sigurnost primjene lijeka Viekirax u djece i adolescenata mlađih od 18 godina nije ustanovljena.
English: • Each tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Croatian: • Jedna tableta sadrži sadrži 12,5 mg ombitasvira, 75 mg paritaprevira i 50 mg ritonavira.
English: Tacrolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax and 2 mg was administered with Viekirax + dasabuvir.
Croatian: Takrolimus od 2 mg je primijenjen sam, 0,5 mg je primijenjen s lijekom Viekirax te je od 2 mg primijenjen s lijekom Viekirax + dasabuvir.
English: No dose adjustment needed for Viekirax with dasabuvir.
Croatian: Nije potrebno prilagođavati dozu za lijek Viekirax s dasabuvirom.
English: Caution should be used and dose decrease maybe needed for repaglinide when administered with Viekirax with or without dasabuvir.
Croatian: Potreban je oprez te će možda biti potrebno smanjenje doze repaglinida kada se primjenjuje istodobno s lijekom Viekirax s dasabuvirom ili bez njega.
English: SVR12 for genotype 4-infected, subjects who were treatment-naïve or previously treated with pegIFN/RBV in PEARL I
Croatian: Stope SVR12 za ispitanike s infekcijom genotipom 4, prethodno neliječene ili prethodno liječene pegIFN/RBV-om u ispitivanju PEARL I
English: Viekirax is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.3 and 5.2).
Croatian: Viekirax je kontraindiciran u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (Child-Pugh stadij B ili C) (vidjeti dijelove 4.3 i 5.2).
English: Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong inhibitors of CYP3A4 is expected to increase paritaprevir plasma concentrations and must not be co-administered with Viekirax (see section 4.5).
Croatian: Očekuje se da će istodobna primjena lijeka Viekirax s dasabuvirom ili bez njega i lijekova koji su snažni inhibitori CYP3A4 povisiti koncentracije paritaprevira u plazmi te se ne smiju primjenjivati istodobno s lijekom Viekirax (vidjeti dio 4.5).
English: The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Croatian: Jačina interakcije bila je slična onoj primijećenoj kod primjene kombinacije Viekirax + dasabuvir.
English: Clinical monitoring and dose adjustment maybe needed for s-mephenytoin.
Croatian: Može biti potrebno kliničko praćenje i prilagodba doze S-mefenitoina.
English: NS3
Croatian: NS5B.
English: Treated subjects (N=68) had a median age of 58 years (range: 32-77 years); 83.8% were male; 58.8% were Black; 73.5% of subjects were infected with HCV GT1a; 75.0%% had Stage 5 CKD and 69.1% were on haemodialysis.
Croatian: iznosio je 58 godina (raspon: 32-77 godina); 83,8% bili su muškarci; 58,8% bili su crnci; 73,5% ispitanika bilo je inficirano HCV-om genotipa 1a; 75,0% imalo je kroničnu bubrežnu bolest stadija 5, a 69,1% ispitanika bilo je na hemodijalizi.
English: Effect of paritaprevir/ritonavir on ombitasvir and dasabuvir
Croatian: Učinak paritaprevira/ritonavira na ombitasvir i dasabuvir
English: Side effects when taking Viekirax with or without dasabuvir and with or without ribavirin:
Croatian: Nuspojave koje se javljaju kada se Viekirax uzima u kombinaciji s dasabuvirom ili bez njega i u kombinaciji s ribavirinom ili bez njega:
English: 95% CIa F0-F1
Croatian: SVR12 95% CIa
English: If clinically indicated, higher doses of esomeprazole/lansoprazole may be needed.
Croatian: Primijeniti veće doze esomeprazola/lanzoprazola,
English: ↓ voriconazole ↑ paritaprevir ↑ dasabuvir
Croatian: ↓ vorikonazol ↑ paritaprevir ↑ dasabuvir
English: Metabolism and nutrition disorders Uncommon
Croatian: Poremećaji metabolizma i prehrane manje često dehidracija Psihijatrijski poremećaji vrlo često nesanica
English: Medicinal products metabolised by CYP3A4
Croatian: Lijekovi koji se metaboliziraju posredstvom enzima CYP3A4
English: 20-120 mg once daily8
Croatian: OPIOIDI metadon 20-120 mg jedanput na dan8
English: 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]).
Croatian: Ispitanici s jetrenim transplantatom i cirozom primali su lijek Viekirax i dasabuvir u kombinaciji s RBV-om (ispitanici s genotipom 1a tijekom 24 tjedna [n=4], ispitanici s genotipom 1b tijekom 12 tjedana [n=2]).
English: Poly(vinyl alcohol) (E 1203) Macrogol (3350) Talc (E 553b)
Croatian: poli(vinilni alkohol) (E 1203) makrogol (3350) talk (E 553b) titanijev dioksid (E 171) željezov oksid, crveni (E 172)
English: The interaction between Viekirax with or without dasabuvir and colchicine has not been evaluated.
Croatian: Interakcija između lijeka Viekirax, u primjeni s dasabuvirom ili bez njega, i kolhicina nije ispitana.
English: Phenytoin
Croatian: fenitoin
English: Use of colchicine is contraindicated with Viekirax with or without dasabuvir in patients with renal or hepatic impairment (see sections 4.3 and 4.4).
Croatian: Primjena kolhicina je kontraindicirana s lijekom Viekirax s dasabuvirom ili bez njega u bolesnika s oštećenjem funkcije bubrega ili jetre (vidjeti dijelove 4.3 i 4.4)
English: Increase in dasabuvir exposure is possibly due to CYP2C8 inhibition and increase in paritaprevir possibly due to OATP1B1 inhibition by gemfibrozil.
Croatian: : Povećanje izloženosti dasabuviru moglo bi biti posljedica inhibicije CYP2C8, a povećanje izloženosti paritaprevir u moglo bi biti posljedica paritaprevir/ ritonavir + dasabuvir paritaprevir
English: A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with Viekirax.
Croatian: Preporučuje se privremeno prekinuti primjenu pitavastatina/fluvastatina tijekom liječenja s lijekom
English: This is because serious or lifethreatening effects can occur when Viekirax is taken with these medicines.
Croatian: Viekirax s tim lijekovima može izazvati ozbiljne ili po život opasne učinke.
English: Indinavir Saquinavir Tipranavir
Croatian: paritaprevir indinavir sakvinavir
English: Paritaprevir /ritonavir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 38-fold higher than those in humans at the recommended dose of 150 mg.
Croatian: 6-mjesečnom istraživanju na transgeničnim miševima, paritaprevir/ritonavir nije bio kancerogen ni pri najvišoj ispitivanoj dozi (300 mg/30 mg/kg/dan), koja je dovela do približno 38 puta veće izloženosti paritapreviru (određene na temelju AUC-a) od izloženosti koja se postiže u ljudi nakon primjene preporučene doze od 150 mg.
English: Each film coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Croatian: Jedna filmom obložena tableta sadrži 12,5 mg ombitasvira, 75 mg paritaprevira i 50 mg ritonavira.
English: Dose normalized cyclosporine ratios are shown for interaction with Viekirax with or without dasabuvir.
Croatian: Omjeri normalizirani za dozu ciklosporina prikazani su za interakciju s lijekom Viekirax s dasabuvirom ili bez njega.
English: Treatment with darunavir + Viekirax without dasabuvir is not recommended-(↑ paritaprevir).
Croatian: Liječenje darunavirom u kombinaciji s lijekom Viekirax bez dasabuvira ne preporuča se (↑
English: Ombitasvir has EC50 values of 12, 4.3, 19, 1.7, 3.2, and 366 pM against replicon cell lines constructed with NS5A from single isolates representing genotypes 2a, 2b, 3a, 4a, 5a, and 6a, respectively.
Croatian: ombitasvira protiv staničnih linija replikona konstruiranih s NS5A iz pojedinačnih izolata koji su predstavljali genotipove 2a, 2b, 3a, 4a, 5a odnosno 6a iznosile su 12; 4,3; 19; 1,7; 3,2 odnosno 366 pM.
English: Darunavir combined with Viekirax + dasabuvir is not recommended in patients with extensive PI resistance.
Croatian: Darunavir u kombinaciji s lijekom Viekirax s dasabuvirom ne preporuča se kod bolesnika koji imaju ombitasvir paritaprevir dasabuvir
English: ↑ itraconazole ↑ posaconazole ↑ paritaprevir ↑ dasabuvir
Croatian: ↑ itrakonazol ↑ posakonazol ↑ paritaprevir ↑ dasabuvir
English: Similar effect is expected as observed with Viekirax + dasabuvir.
Croatian: Očekuje se učinak sličan onome primijećenom kod primjene kombinacije Viekirax + dasabuvir.
English: No dose adjustment of Viekirax with and without dasabuvir is required for patients with mild, moderate or severe renal impairment , or end-stage-renal disease on dialysis (see section 4.2).
Croatian: Nije potrebno prilagođavati dozu lijeka Viekirax u kombinaciji s dasabuvirom ili bez njega u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega, ili u bolesnika sa završnim stadijem bubrežne bolesti koji su na dijalizi (vidjeti dio 4.2).
English: Caution should be used when sulfasalazine is coadministered with Viekirax with or without dasabuvir.
Croatian: Potreban je oprez kada se sulfosalazin primjenjuje istodobno s lijekom Viekirax s dasabuvirom ili bez njega.
English: Sirolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax + dasabuvir.
Croatian: Sirolimus se u dozi od 2 mg primjenjivao sam, a u dozi od 0,5 mg s lijekom Viekirax + dasabuvirom.
English: 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).
Croatian: Kod bolesnika s oštećenjem funkcije bubrega ili jetre je kontraindicirana istodobna primjena kolhicina i lijeka Viekirax s dasabuvirom ili bez njega (vidjeti dijelove 4.3 i 4.5).
English: 30 mg once daily single dose3
Croatian: 30 mg jedanput na dan pojedinačna doza3 Mehanizam:
English: Mechanism: OATP1B1 inhibition by paritaprevir.
Croatian: Mehanizam : OATP1B1 inhibicija paritaprevir om.
English: In subjects with severe hepatic impairment, paritaprevir mean Cmax and AUC values increased by 3.2-to 9.5-fold; ritonavir mean Cmax values were 35% lower and AUC values were 13% higher and ombitasvir mean Cmax and AUC values decreased by 68% and 54%, respectively, compared to subjects with normal hepatic function, therefore, Viekirax must not be used in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Croatian: U ispitanika s teškim oštećenjem funkcije jetre, srednja vrijednost Cmax i AUC-a paritaprevira povećala se 3,2 do 9,5 puta; srednja vrijednost Cmax ritonavira bila je 35% manja, a vrijednost AUC-a 13% veća, dok se srednja vrijednost Cmax ombitasvira smanjila za 68%, a srednja vrijednost AUC-a za 54% u usporedbi s ispitanicima s normalnom funkcijom jetre.
English: S-warfarin ombitasvir paritaprevir dasabuvir
Croatian: S-varfarin ombitasvir paritaprevir dasabuvir
English: Co-administration of Viekirax and dasabuvir with systemic tacrolimus, sirolimus or everolimus increases the concentrations of the immunosuppressant due to CYP3A inhibition by ritonavir (see section 4.5).
Croatian: Primjena s takrolimusom, sirolimusom i everolimusom Istodobna primjena lijeka Viekirax i dasabuvira sa sistemskim takrolimusom, sirolimusom ili everolimusom povećava koncentracije imunosupresivnog lijeka zbog inhibicije izoenzima CYP3A
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in non-HCV infected subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment.
Croatian: Farmakokinetika kombinacije ombitasvira u dozi od 25 mg, paritaprevira u dozi od 200 mg i ritonavira u dozi od 100 mg s dasabuvirom u dozi od 400 mg ocijenjena je u ispitanika neinficiranih HCV-om s blagim (Child-Pugh stadij A), umjerenim (Child-Pugh stadij B) i teškim (Child-Pugh stadij C)
English: ↑ fluticasone
Croatian: ↑ flutikazon
English: Following administration of Viekirax and dasabuvir
Croatian: Nakon primjene lijeka Viekirax i dasabuvira
English: lamivudine ombitasvir paritaprevir
Croatian: ↓ lamivudin ombitasvir paritaprevir
English: Ombitasvir and paritaprevir do not inhibit organic anion transporter (OAT1) in vivo and are not expected to inhibit organic cation transporters (OCT1 and OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations.
Croatian: Ombitasvir i paritaprevir ne inhibiraju prijenosnik organskih aniona (OAT1) in vivo te se ne očekuje da će inhibirati prijenosnike organskih kationa (OCT1 i OCT2), prijenosnike organskih aniona
English: ↔ digoxin
Croatian: ↔ digoksin
English: Dose decrease and clinical monitoring of calcium channel blockers is recommended when coadministered with Viekirax with and without dasabuvir.
Croatian: Preporučuje se smanjenje doze blokatora kalcijevih kanala i kliničko praćenje kada se primjenjuju istodobno s lijekom Viekirax s dasabuvirom ili bez njega.
English: Viekirax safety and efficacy have been established in combination with dasabuvir and/or ribavirin.
Croatian: Istodobna primjena s drugim direktno djelujućim antiviroticima protiv HCV-a Ustanovljene su sigurnost i djelotvornost lijeka Viekirax u kombinaciji s dasabuvirom i/ili ribavirinom.
English: Effect of ombitasvir on paritaprevir/ritonavir and dasabuvir
Croatian: Učinak ombitasvira na paritaprevir/ritonavir i dasabuvir
English: Viekirax with dasabuvir
Croatian: Viekirax s dasabuvirom
English: 500 mg single dose
Croatian: 500 mg pojedinačna doza
English: During clinical trials with Viekirax and dasabuvir with or without ribavirin, transient elevations of ALT to greater than 5 times the upper limit of normal occurred in approximately 1% of subjects (35 of 3,039).
Croatian: Tijekom kliničkih ispitivanja lijeka Viekirax i dasabuvira s ribavirinom ili bez njega došlo je do prolaznog povišenja razina ALT-a više od 5 puta iznad gornje granice normale (GGN) kod oko
English: Viekirax with or without dasabuvir
Croatian: Viekirax sa ili bez dasabuvira
English: 600/100 mg twice daily
Croatian: 600/100 mg dvaput na dan
English: Viekirax and dasabuvir with/without ribavirin for 12 or 24 Weeks N = 200a
Croatian: Viekirax i dasabuvir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna N = 200a
English: Dose normalized tacrolimus ratios are shown for interaction with Viekirax with or without dasabuvir.
Croatian: Omjeri normalizirani za dozu takrolimusa prikazani su za interakciju s lijekom Viekirax s dasabuvirom ili bez njega.
English: THYROID HORMONES
Croatian: TIROIDNI HORMONI levotiroksin
English: Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL increase in
Croatian: Potvrđena razina HCV-a od ≥ 25 IU/ml nakon što je HCV RNK tijekom liječenja bio < 25 IU/ml, potvrđeno povećanje HCV RNK od 1 log10 IU/ml u odnosu na najnižu zabilježenu vrijednosti (nadir) ili postojana razina
English: Primary SVR12 Assessment for Part 2 Subjects with HCV GT1/HIV-1 co-infection in TURQUOISE-I
Croatian: Primarna ocjena SVR12 u 2. dijelu ispitivanja TURQUOISE-I kod ispitanika s istodobnom infekcijom HCV-om genotipa 1 i HIV-om tipa 1
English: Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir
Croatian: Viekirax 12,5 mg / 75 mg / 50 mg filmom obložene tablete ombitasvir / paritaprevir / ritonavir
English: Nearly the entire plasma radioactivity after a single 600 mg dose of 14C-ritonavir oral solution in humans was attributed to unchanged ritonavir.
Croatian: Nakon primjene jednokratne doze od 600 mg oralne otopine 14C-ritonavira u ljudi, gotovo cjelokupna radioaktivnost u plazmi pripisana je ritonaviru u neizmijenjenu obliku.
English: Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Croatian: Varijante M414T, G554S, S556G, G558R ili
English: CYP3A4 substrates:
Croatian: Supstrati za CYP3A4:
English: SEDATIVES / HYPNOTICS Zolpidem
Croatian: SEDATIVI / HIPNOTICI zolpidem pojedinačna doza od 5 mg
English: Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir.
Croatian: CYP3A4/Pgp inhibicija erithromicin om, paritaprevir om, ritonavirom i dasabuviro m.
English: Do not take Viekirax if any of the above apply to you.
Croatian: tikagrelor za sprječavanje zgrušavanja krvi Nemojte uzeti lijek Viekirax ako se nešto od navedenoga odnosi na Vas.
English: Treatment-naïve pegIFN + RBV experienced Prior relapse Prior partial response Prior null response 100% (32/32) Other pegIFN/RBV failures TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure.
Croatian: +Ostale vrste neuspjeha liječenja kombinacijom pegIFN/RBV uključuje manji precizno dokumentirani izostanak odgovora, relaps/proboj ili druge oblike neuspjeha liječenja kombinacijom pegIFN/RBV.
English: GT1 Arm A: Viekirax and dasabuvir + RBV Arm B: Placebo
Croatian: skupina A: Viekirax i dasabuvir + RBV skupina B: placebo
English: Following administration of a single 200 mg/100 mg oral dose of 14C paritaprevir /ritonavir to humans, the parent drug was the major circulating component, accounting for approximately 90% of the plasma radioactivity.
Croatian: 200 mg/100 mg u ljudi, glavna cirkulirajuća komponenta bio je ishodišni spoj, koji je činio približno 90% radioaktivnosti u plazmi.
English: GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
Croatian: GT1b skupina A: Viekirax i dasabuvir + RBV skupina B: Viekirax i dasabuvir
English: SVR12 for Genotype 1b-infected treatment-naïve subjects without cirrhosis
Croatian: SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1b, bez ciroze
English: With RBV n/N % n/N % n/N %
Croatian: Prethodno liječeni pegIFN + RBV s RBV-om n/N % n/N % n/N %
English: Concomitant use is contraindicated (See section
Croatian: Istodobna primjena je kontraindicirana (vidjeti dio
English: In subjects with moderate hepatic impairment, ombitasvir and ritonavir mean Cmax and AUC values decreased by 29% to 30% and 30 to 33%, respectively, while paritaprevir mean Cmax and AUC values increased by 26% to 62% compared to subjects with normal hepatic function.
Croatian: U ispitanika s umjerenim oštećenjem funkcije jetre, srednje vrijednosti Cmax i AUC-a ombitasvira i ritonavira smanjile su se za 29% do 30% odnosno za 30% do 33%, srednje vrijednosti Cmax i AUC-a paritaprevira povećale su se za 26% do 62%, u usporedbi s ispitanicima s normalnom funkcijom jetre (vidjeti dijelove 4.2, 4.4 i 4.8).
English: SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatmentnaïve or previously treated with pegIFN/RBV
Croatian: Tablica 13. SVR12 za ispitanike s infekcijom genotipom 1 i kompenziranom cirozom koji prethodno nisu bili liječeni ili su primali pegIFN/RBV Ishod liječenja
English: No study related adverse reactions with paritaprevir, ritonavir, or ombitasvir were observed.
Croatian: Nisu zabilježene nuspojave povezane s ispitivanim lijekom paritaprevirom, ritonavirom ili ombitasvirom.
English: ↑ Sulfamethoxazole,
Croatian: Sulfametoksazol,
English: GT1a Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir
Croatian: GT1a skupina A: Viekirax i dasabuvir + RBV skupina B: Viekirax i dasabuvir
English: Expected: ↑ amiodarone
Croatian: ↑ amiodaron
English: Viekirax and dasabuvir + ribavirin
Croatian: Viekirax i dasabuvir + ribavirin
English: Viekirax without dasabuvir rosuvastatin
Croatian: Viekirax bez dasabuvira rosuvastatin
English: ↑ colchicine
Croatian: ↑ kolhicin
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medicines after starting Viekirax.
Croatian: Nakon što počnete uzimati lijek Viekirax, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijekove protiv šećerne bolesti.
English: If you are not sure, talk to your doctor or pharmacist before taking Viekirax.
Croatian: Ako se bilo što od navedenoga odnosi na Vas (ili niste sigurni), razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete lijek Viekirax.
English: If the combination is used, repeated ECG-monitoring should be done, see section 4.4.
Croatian: Ako se primjenjuje kombinacija, potrebno je redovito EKG praćenje,