FrancophonIA/ELRC3.0 huggingface dataset:
English: A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 68.4% had IL28B non-CC genotype; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
Croatian: 800,000 IU/ml a većina (84.2%) je imala infekciju HCV-om genotipa 1a, 68,4% je imalo IL28B nonCC genotip, 15,8% je imalo portalnu fibrozu (F2) a 5,3% premoštavajuću („bridging“) fibrozu (F3)
English: The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: Preporučena doza atazanavira je 300 mg bez primjene ritonavira s lijekom Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Dasabuvir is predominantly metabolised by CYP2C8 and to a lesser extent by CYP3A.
Croatian: Dasabuvir se najvećim dijelom metabolizira posredstvom CYP2C8, a u manjoj mjeri posredstvom
English: No dose adjustment of Exviera 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 Exviera 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: No dose adjustment of Exviera 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 Exviera 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: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg tablets dasabuvir
Croatian: NAZIV LIJEKA Exviera 250 mg tablete dasabuvir
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Croatian: primijećena su prolazna povišenja razina bilirubina u serumu (najčešće indirektnog bilirubina), što je bilo povezano s inhibicijom prijenosnika bilirubina OATP1B1/1B3 koju uzrokuje paritaprevir te hemolizom induciranom primjenom ribavirina.
English: ANTIARRYTHMICS
Croatian: ANTIKONVULZIVI
English: ANTICANCER AGENTS Enzalutamid e
Croatian: ANTITUMORSKI LIJEKOVI Enzalutamid
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 with or without naloxone (N=19) received 12 weeks of Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
Croatian: Kliničko ispitivanje u ispitanika na zamjenskoj terapiji kod liječenja ovisnosti o opioidima U fazi 2 multicentričnog, otvorenog ispitivanja s jednom skupinom od 38 neliječenih ispitanika ili liječenih kombinacijom pegIFN/RBV, bez ciroze, s infekcijom HCV-om genotipa 1 koji uzimaju stalnu dozu metadona (N=19) ili buprenorfina s ili bez naloksona (N=19), ispitanici su tijekom 12 tjedana primali lijekove Exviera i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom.
English: Clinical Trial in subjects with HCV genotype 1 Infection/HIV-1 co-infection
Croatian: Kliničko ispitivanje s ispitanicima koji imaju infekciju genotipom 1 HCV-a i istodobnu infekciju virusom HIV -1
English: When starting coadministration with dasabuvir and ombitasvir/paritaprevir/ ritonavir administer 0.5 mg tacrolimus once every week.
Croatian: Kada se započinje istodobna primjena s dasabuvirom i ombitasvirom/paritaprevi rom/ritonavirom, primijeniti 0,5 mg
English: Clinical Comments ritonavir.
Croatian: uključujući ritonavir.
English: Phenobarbita l
Croatian: Karisoprodo l
English: Treatment-emergent amino acid substitutions in the pooled analysis of Exviera and ombitasvir/paritaprevir/ritonavir, with and without RBV regimens in Phase 2b and Phase 3 clinical trials (N=2510)
Croatian: Tablica 5. Aminokiselinske supstitucije nastale tijekom liječenja primijećene u analizi objedinjenih podataka za režime liječenja lijekovima Exviera i ombitasvir/paritaprevir/ritonavir, s ribavirinom ili bez njega, u kliničkim ispitivanjima faze 2b i faze 3 (N=2510)
English: The majority of adverse reactions presented in Table 3 were of grade 1 severity in Exviera- and ombitasvir/paritaprevir/ritonavir-containing regimens.
Croatian: Većina nuspojava navedenih u Tablici 3 bila je 1. stupnja težine u režimima liječenja koji su sadržavali lijekove Exviera i ombitasvir/paritaprevir/ritonavir.
English: r paritaprevir
Croatian: ↓ paritaprevir
English: NARCOTIC ANALGESICS Paracetamol (given as fixed dose hydrocodone /paracetamol
Croatian: ↔ dasabuvir ombitasvir paritaprevir hidrokodon (primijenjen kao fiksna kombinacija hidrokodon/ paracetamol
English: Tacrolimus 2 mg single dose4
Croatian: Takrolimus 2 mg pojedinačna
English: Co-administration of Exviera with medicinal products that are strong or moderate enzyme inducers is expected to decrease dasabuvir plasma concentrations and reduce its therapeutic effect (see section 4.5.
Croatian: Pri istodobnoj primjeni lijeka Exviera s lijekovima koji su snažni ili umjereni induktori enzima očekuje se snižavanje koncentracije dasabuvira u plazmi i smanjenje njegovog terapijskog učinka
English: metabolite were not meaningfully different in subjects with hepatic impairment compared to normal control subjects (see sections 4.2, 4.4 and 4.8).
Croatian: Vezanje dasabuvira i M1 metabolita na proteine plazme nije bilo značajno različito u odnosu na kontrolnu skupinu (vidjeti dijelove 4.2, 4.4 i 4.8).
English: PEARL-II - genotype 1b, peginterferon+ribavirin-experienced
Croatian: PEARL-II - ispitanici s infekcijom genotipom 1b prethodno liječeni kombinacijom peginterferon+ribavirin
English: Exviera and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
Croatian: Exviera i ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2044
English: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets
Croatian: NAZIV LIJEKA Exviera 250 mg filmom obložene tablete
English: Table 2.
Croatian: Tablicu 2).
English: PEARL-II was a randomised, global multicentre, open-label trial conducted in 179 adults with chronic genotype 1b hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Croatian: PEARL-II bilo je randomizirano, globalno, multicentrično, otvoreno ispitivanje provedeno u 179 odraslih ispitanika s kroničnom infekcijom virusom hepatitisa C genotipa 1b bez ciroze koji nisu postigli SVR uz prethodno liječenje kombinacijom pegIFN/RBV.
English: Duration
Croatian: TVARI
English: Table 3 lists adverse reactions for which a causal relationship between dasabuvir, in combination with ombitasvir/paritaprevir/ritonavir, with or without ribavirin, and the adverse event is at least a reasonable possibility.
Croatian: Tablici 3 navode se nuspojave za koje se može s razumnom vjerojatnošću smatrati da su uzročno povezane s primjenom dasabuvira u kombinaciji s ombitasvirom/paritaprevirom/ritonavirom s ili bez ribavirina.
English: Table 12 shows the SVR12 rates for genotype 1-infected subjects with compensated cirrhosis who were treatment-naïve or previously treated with pegIFN/RBV.
Croatian: U Tablici 12 prikazane su stope SVR12 za ispitanike s infekcijom genotipom 1 i kompenziranom cirozom koji prethodno nisu bili liječeni ili su primali pegIFN/RBV
English: The replicon activity of dasabuvir was attenuated 12- to 13
Croatian: Aktivnost dasabuvira protiv replikona bilo je 12 do 13 puta slabije u prisutnosti 40% ljudske plazme.
English: Other pegIFN/RBV failures
Croatian: Ostale vrste neuspjeha liječenja kombinacijom pegIFN/RBV UKUPNO
English: No increase in incidence of ALT elevations was observed with other types of systemic estrogens commonly used for hormone replacement therapy (e.g., estradiol and conjugated estrogens).
Croatian: U ispitanica koje su primale druge vrste sistemskih lijekova koji sadrže estrogene i uobičajeno se koriste u hormonskom nadomijesnom liječenju (npr. estradiol i konjugirani estrogeni), povećanje incidencije povišenja razine ALT-a nije zabilježeno.
English: SAPPHIRE-I was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 631 treatment-naïve adults with genotype 1 chronic hepatitis C virus infection without cirrhosis.
Croatian: SAPPHIRE-I bilo je randomizirano, globalno, multicentrično, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno u 631 prethodno neliječenog odraslog ispitanika s kroničnom infekcijom virusom hepatitisa C genotipa 1 bez ciroze.
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 81% of subjects had IL28B non-CC genotype; 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.
Croatian: Medijan dobi liječenih ispitanika (N=63) iznosio je 51 godinu (raspon: 31 do 69), 24% ispitanika bili su crnci, 81% ispitanika imalo je IL28B non-CC genotip, 19 % je imalo kompenziranu cirozu, 67% ispitanika nije prethodno liječilo infekciju HCV-om, 33% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 89% ispitanika imalo je infekciju HCV-om genotipa 1a.
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
Croatian: skupina A: Exviera i ombitasvir/paritaprevir/ritonavir + RBV skupina B: placebo
English: Exviera and ombitasvir/paritaprevir/ritonavir were given for 12 weeks of treatment in combination with ribavirin.
Croatian: Exviera i ombitasvir/paritaprevir/ritonavir primjenjivali su se tijekom 12 tjedana liječenja u kombinaciji s ribavirinom.
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Croatian: Exviera i ombitasvir/paritaprevir/ritonavir s RBV-om tijekom 12 tjedana n/N % 95% CI
English: SAPPHIRE-II was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 394 subjects with genotype 1 chronic hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Croatian: SAPPHIRE-II bilo je randomizirano, globalno, multicentrično, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno u 394 ispitanika s kroničnom infekcijom virusom hepatitisa C genotipa 1 bez ciroze koji nisu postigli SVR uz prethodno liječenje kombinacijom pegIFN/RBV.
English: Genotype 1a N=67
Croatian: Genotip 1a N=67b % (n)
English: Mechanism: CYP2C19 induction by ritonavir.
Croatian: Mehanizam: CYP2C19 indukcija ritonavirom
English: Geometric mean Cmax, AUC of multiple doses of Exviera 250 mg twice daily and ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily with food in healthy volunteers
Croatian: Tablica 17. Geometrijske srednje vrijednosti Cmax i AUC-a nakon višekratnih doza lijeka Exviera 250 mg dvaput na dan i ombitasvirom/paritaprevirom/ritonavirom 25 mg/150 mg/100 mg jedanput na dan primijenjenih s hranom u zdravih dobrovoljaca
English: ANTICONVULSANTS carbamazepine
Croatian: Klinička napomena karbamazepin
English: Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received open-label Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Croatian: Ispitanici randomizirani u skupinu koja je primala placebo dobivali su placebo tijekom 12 tjedana, a nakon toga su u otvorenom dijelu ispitivanja tijekom 12 tjedana primali lijekove Exviera i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom.
English: Dose normalized cyclosporine ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Croatian: Omjeri normalizirani za dozu ciklosporina prikazani su za interakciju s lijekom Exviera + ombitasvir/paritaprevir/ritonavir.
English: Clinical Trial in patients receiving chronic opioid substitution therapy
Croatian: Klinička ispitivanja na bolesnicima s jetrenim presatkom
English: Phase 3 global multicentre trials conducted with Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin (RBV).
Croatian: Tablica 6. Globalna, multicentrična ispitivanja faze 3 provedena s lijekovima Exviera i ombitasvir/paritaprevir/ritonavir, u kombinaciji s ribavirinom (RBV) ili bez njega
English: Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin were administered for either 12 or 24 weeks of treatment.
Croatian: Exviera i ombitasvir/paritaprevir/ritonavir primjenjivali su se u kombinaciji s ribavirinom tijekom 12 ili 24 tjedna liječenja.
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Croatian: SVR12 za ispitanike s infekcijom genotipom 1 prethodno liječene kombinacijom peginterferon+ribavirin u ispitivanju SAPPHIRE-II
English: Mechanism: BCRP and Pgp inhibition by paritaprevir, ritonavir and dasabuvir
Croatian: Mehanizam: BCRP i Pgp inhibicija paritaprevir om, ritonavirom i dasabuviro m
English: Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Croatian: Ispitanici randomizirani u skupinu koja je primala placebo dobivali su placebo tijekom 12 tjedana, a nakon toga su tijekom 12 tjedana primali lijekove Exviera i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom.
English: Co-administration of dasabuvir with medicinal products that inhibit CYP2C8 (e.g. teriflunomide, deferasirox) may increase dasabuvir plasma concentrations.
Croatian: Istodobna primjena dasabuvira i lijekova koji inhibiraju CYP2C8 (npr. teriflunomid, deferasiroks)
English: Microcrystalline cellulose (E460(i)) Lactose monohydrate Copovidone
Croatian: celuloza, mikrokristalična (E460(i))
English: NA Concomitant use is contraindicated (see the Summary of Product Characteristics for ombitasvir/paritaprevir/ ritonavir).
Croatian: NP Istodobna primjena je kontraindicirana (vidjeti Sažetak opisa svojstava lijeka ombitasvir/paritaprevir/ri tonavir)
English: Treatment duration was fixed in each trial and was not guided by subjects'
Croatian: Trajanje liječenja u svakom je ispitivanju bilo fiksno i nije se vodilo prema razinama HCV RNK u ispitanika (nije se primjenjivao algoritam liječenja prema odgovoru).
English: In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had similar SVR12 rates (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (99.5%).
Croatian: U tom su ispitivanju stope SVR12 uz primjenu lijekova Exviera i ombitasvir/paritaprevir/ritonavir bez ribavirina (100%) bile slične onima postignutima uz primjenu lijekova Exviera i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom (99,5%).
English: ANTIBIOTICS (SYSTEMIC ADMINISTRATION) Sulfamethoxazole, trimethoprim
Croatian: Sulfametoks azol, trimetoprim
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
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: No dose adjustment is necessary for emtricitabine/tenofovir and Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: Nije potrebno prilagođavati dozu za emtricitabin/tenofovir i Exviera + ombitasvir/paritaprevir/ri tonavir.
English: Refer to the Summary of Product Characteristics of ombitasvir/paritaprevir/ritonavir for its pharmacological properties.
Croatian: Za informacije o farmakološkim svojstvima lijekova koji sadrže ombitasvir/paritaprevir/ritonavir pročitati njihov Sažetak upute o svojstvima lijeka.
English: Table 10 shows the SVR12 rates for treatment-experienced subjects with genotype 1-infection receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-II.
Croatian: Tablici 10 prikazane su stope SVR12 za prethodno liječene ispitanike s infekcijom genotipom 1 koji su primali lijekove Exviera i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom tijekom 12 tjedana u ispitivanju SAPPHIRE-II.
English: CYP3A4 inhibition by ritonavir.
Croatian: CYP3A4 inhibicija ritonavirom
English: The effect on Cmax and AUC of DAAs and lopinavir was similar to that observed when lopinavir/ritonavir 400/100 mg twice daily was administered with dasabuvir and ombitasvir/paritaprevir/ritonavir.
Croatian: Učinak na Cmax i AUC antivirusnih lijekova izravnog učinka i lopinavira bila je slična kao i kad se doza od 400/100 mg lopinavira/ritonavira primjenila dvaput
English: SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Croatian: Tablica 11. SVR12 za ispitanike s infekcijom genotipom 1b prethodno liječene kombinacijom peginterferon+ribavirin u ispitivanju PEARL II
English: In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had a similar SVR12 rate (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (97.7%).
Croatian: Exviera i ombitasvir/paritaprevir/ritonavir bez ribavirina (100%) bila slična onoj postignutoj uz primjenu lijekova Exviera i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom (96,6%).
English: Subjects were randomised in a 1:1 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Croatian: Ispitanici su bili randomizirani u omjeru 1:1 za primanje lijekova Exviera i ombitasvir/paritaprevir/ritonavir, s ribavirinom ili bez njega, tijekom 12 tjedana liječenja.
English: HCV Genotype 1a Exviera and ombitasvir/paritaprevir/ritonavir with RBV
Croatian: HCV genotipa 1a Exviera i ombitasvir/paritaprevir/ritonavir
English: Dose normalized tacrolimus ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Croatian: Omjeri normalizirani za dozu takrolimusa prikazani su za interakciju s lijekom Exviera + ombitasvir/paritaprevir/ritonavir.
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Croatian: GT1a skupina A: Exviera i ombitasvir/paritaprevir/ritonavir + RBV skupina B: Exviera i ombitasvir/paritaprevir/ritonavir
English: The majority of these ALT elevations were transient and assessed as related to Exviera and ombitasvir/paritaprevir/ritonavir.
Croatian: Većina tih povišenja razine ALT-a bila su prolaznog karaktera i ocijenjena kao povezana s primjenom lijeka Exviera s ombitasvirom/paritaprevirom/ritonavirom.
English: SVR12 for HIV-1 co-infected Subjects in TURQUOISE-I
Croatian: Stopa SVR12 kod ispitanika koji imaju istodobnu infekciju virusom HIV-1 u kliničkom ispitivanju TURQUOISE-I
English: Ciclosporin 100 mg dosed alone and 30 mg administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Croatian: Samostalna doza od 100 mg ciklosporina ili doza od 30 mg ciklosporina primijenjena s lijekovima Exviera i ombitasvir/paritaprevir/ritonavir.
English: Tacrolimus 2 mg was dosed alone and 2 mg was administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Croatian: Samostalna doza od 2 mg takrolimusa i doza od 2 mg primijenjena s lijekovima Exviera i ombitasvir/paritaprevir/ritonavir.
English: ↑ Sulfamethoxazole,
Croatian: Atazanavir se
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV 12 weeks
Croatian: Exviera i ombitasvir/paritaprevir/ritonavir s RBV-om 12 tjedana
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 250 mg dasabuvira (u obliku natrijeva hidrata).
English: The pharmacokinetic properties of the combination of Exviera with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 17 shows mean Cmax and AUC of Exviera 250 mg twice daily with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily following multiple doses with food in healthy volunteers.
Croatian: U Tablici 17 navode se srednje vrijednosti Cmax i AUC-a lijeka Exviera u dozi od 250 mg dvaput na dan u kombinaciji s ombitasvirom/paritaprevirom/ritonavirom u dozi od 25 mg/150 mg/100 mg jedanput na dan nakon višekratnih doza primijenjenih s hranom u zdravih dobrovoljaca.
English: Treatment-naïve and peginterferon+ribavirin-experienced, with compensated cirrhosis
Croatian: Ispitanici prethodno liječeni s kombinacijom peginterferon+ribavirin, bez ciroze
English: 20-120 mg once daily5
Croatian: 20-120 mg jedanput na dan
English: *Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
Croatian: 24 tjedna (vidjeti dio 5.1.) *Napomena: za bolesnike s infekcijom genotipom 1 nepoznatog podtipa ili mješovitom infekcijom genotipom 1 preporuča se slijediti upute navedene za liječenje bolesnika s infekcijom genotipom 1a.
English: Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir.
Croatian: Mehanizam: crijevna Pgp inhibicija paritaprevir om i ritonavirom.
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 16.2% had a body mass index of at least 30 kg/m2; 15.2% had a history of depression or bipolar disorder; 69.3% had IL28B non-CC genotype; 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: Medijan dobi liječenih ispitanika (N=631) iznosio je 52 godine (raspon: 18 do 70); 54,5% bili su muškarci; 5,4% bili su crnci; 16,2% imalo je indeks tjelesne mase od najmanje 30 kg/m2; 15,2% imalo je depresiju ili bipolarni poremećaj u anamnezi; 69,3% imalo je IL28B non-CC genotip; 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: ↔ digoxin 1.15
Croatian: ↑ furosemid 1,42
English: Mechanism: CYP3A4 induction by phenytoin.
Croatian: Mehanizam: indukcija CYP3A4 fenitoinom
English: Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 16.5% had a body mass index of at least 30 kg/m2; 9.3% had a history of depression or bipolar disorder; 79.0% had IL28B non-CC genotype; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
Croatian: Medijan dobi liječenih ispitanika (N=419) iznosio je 50 godina (raspon: 19 do 70); 45,8% bili su muškarci; 4,8% bili su crnci; 16,5% imalo je indeks tjelesne mase od najmanje 30 kg/m2; 9,3% imalo je depresiju ili bipolarni poremećaj u anamnezi; 79,0% imalo je IL28B non-CC genotip; 73,3% imalo je početnu razinu HCV RNK od najmanje 800 000 IU/ml; 20,3% imalo je portalnu fibrozu (F2), a 10,0% premoštavajuću fibrozu (F3).
English: croscarmellose sodium, colloidal anhydrous silica (E551), magnesium stearate (E470b).
Croatian: Jezgra tablete: mikrokristalična celuloza (E460(i)), laktoza hidrat, kopovidon, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid (E551), magnezijev stearat (E470b).
English: Clinical Comments paritaprevir changes during treatment with Exviera ombitasvir/paritaprevir/ ritonavir
Croatian: To je posljedica promjene funkcije jetre prilikom liječenja lijekom Exviera ombitasvir/paritaprevir/riton avir
English: Caution should be used when sulfasalazine is co-administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Croatian: Sulfasalazin se mora primjenjivati s oprezom istodobno s lijekom Exviera + ombitasvir/paritaprevir/ri tonavir.