FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanism: BCRP inhibition by paritaprevir, ritonavir and dasabuvir.
Croatian: Mehanizam: BCRP inhibicija paritaprevir om, ritonavirom i dasabuviro m.
English: AbbVie Kft. Tel.: +36 1 455 8600
Croatian: Tel.: +36 1 455 8600
English: 0.5 mg single dose
Croatian: 0,5 mg pojedinačna doza
English: The efficacy of dasabuvir has not been established in patients with HCV genotypes other than genotype 1; dasabuvir should not be used for the treatment of patients infected with other genotypes than 1.
Croatian: Dasabuvir se ne smije primjenjivati za liječenje bolesnika koji su inficirani bilo kojim drugim genotipom osim genotipom 1.
English: GARNET - Genotype 1b, Treatment-Naïve without cirrhosis.
Croatian: GARNET - prethodno neliječeni ispitanici s infekcijom genotipom 1b, bez ciroze
English: Side effects when taking Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin:
Croatian: Nuspojave koje se javljaju kada se lijekovi Exviera i ombitasvir/paritaprevir/ritonavir uzimaju s ribavirinom:
English: 40 mg once daily
Croatian: 40 mg jedanput na dan
English: In Part 1b, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 weeks.
Croatian: U dijelu 1b svi su ispitanici primali dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom tijekom 12 tjedana.
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 D559G/N nastale u
English: 600 mg twice daily
Croatian: 600 mg dvaput na dan
English: The recommended dose of darunavir is 800 mg once daily, without ritonavir, when administered at the same time as ombitasvir/paritaprevir/ ritonavir + dasabuvir (ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide darunavir pharmacokinetic enhancement).
Croatian: Preporučena doza darunavira je 800 mg jedanput na dan bez ritonavira kada se primjenjuje u isto vrijeme s ombitasvir/paritaprevir/rito navir + dasabuvir (doza
English: Wort.
Croatian: om.
English: If tacrolimus or sirolimus are used together with dasabuvir and ombitasvir/paritaprevir/ritonavir, caution is advised, and recommended doses and monitoring strategies can be found in section 4.5.
Croatian: Potreban je oprez ako se takrolimus ili sirolimus primjenjuju zajedno s dasabuvirom i ombitasvirom/paritaprevirom/ritonavirom, a preporučene doze i strategije za praćenje nalaze se u dijelu 4.5. Everolimus se ne može primjenjivati jer ne postoje odgovarajuće jačine lijeka za prilagodbu doziranja.
English: Liver transplant subjects with cirrhosis were dosed with dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV (GT1a for 24 weeks [n=4], GT1b for 12 weeks [n=2]).
Croatian: Ispitanici s jetrenim transplantatom i cirozom primali su dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s RBV-om (ispitanici s genotipom 1a tijekom 24 tjedna [n=4], ispitanici s genotipom 1b tijekom 12 tjedana [n=2]).
English: PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design:
Croatian: PEARL-III - prethodno neliječeni ispitanici s infekcijom genotipom 1b, bez ciroze Dizajn:
English: GT1-infected subjects with or without cirrhosis with severe renal impairment or end-stage renal disease (ESRD)
Croatian: Ispitanici s infekcijom genotipom 1, s cirozom ili bez nje, koji imaju teško oštećenje funkcije bubrega ili završni stadij bubrežne bolesti
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Croatian: Tablica 11. SVR12 za ispitanike s infekcijom genotipom 1 prethodno liječene kombinacijom peginterferon+ribavirin u ispitivanju SAPPHIRE-II
English: 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).
Croatian: Medijan dobi liječenih ispitanika (N=305) iznosio je 54 godine (raspon: 19 do 70); 65,2% bili su muškarci; 11,8% bili su crnci; 20,7% imalo je depresiju ili bipolarni poremećaj u anamnezi; 86,6% imalo je početne razine HCV RNK od najmanje 800 000 IU/ml; 18,4% imalo je portalnu fibrozu (F2),
English: Tel: +420 233 098 111
Croatian: AbbVie s.r.o. Tel: +420 233 098 111
English: Cyclobenzap rine 5 mg single dose
Croatian: ↔ dasabuvir ↔ ombitasvir paritaprevir ciklobenzap rin 5 mg pojedinačna doza
English: HIV ANTIVIRALS: NUCLEOSIDE INHIBITORS Abacavir/ lamivudine
Croatian: ANTIVIROTICI ZA LIJEČENJE HIV-a: NUKLEOZIDNI INHIBITORI Abakavir/
English: The majority of these ALT elevations were transient and assessed as related to dasabuvir and ombitasvir/paritaprevir/ritonavir.
Croatian: Većina tih povišenja razine ALT-a bila su prolaznog karaktera i ocijenjena kao povezana s primjenom dasabuvira s ombitasvirom/paritaprevirom/ritonavirom.
English: Esomeprazol e
Croatian: I DOHVATA
English: 50 mg once daily
Croatian: 50 mg jedanput na dan
English: GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (12 weeks)
Croatian: GT1b dasabuvir i ombitasvir/paritaprevir/ritonavir (12 tjedana)
English: This is due to liver function changes during treatment with dasabuvir + ombitasvir/paritaprevir/ ritonavir
Croatian: To je posljedica promjene funkcije jetre prilikom liječenja dasabuvirom + ombitasvir/paritaprevir/rito navir
English: Dasabuvir safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Croatian: Istodobna primjena s drugim direktno djelujućim antiviroticima protiv HCV-a Ustanovljene su sigurnost i djelotvornost dasabuvira u kombinaciji s ombitasvirom/ paritaprevirom /ritonavirom, s ribavirinom ili bez njega.
English: Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 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; 9,3% imalo je depresiju ili bipolarni poremećaj u anamnezi; 73,3% imalo je početnu razinu HCV RNK od najmanje 800 000 IU/ml; 20,3% imalo je portalnu fibrozu (F2), a
English: Atazanavir/ ritonavir 300/100 mg once daily
Croatian: Etinilestradiol/ norgestimat mg jedanput na dan
English: Croscarmellose sodium Colloidal anhydrous silica (E 551) Magnesium stearate (E 470b)
Croatian: celuloza, mikrokristalična (E 460(i)) laktoza hidrat kopovidon karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni (E 551) magnezijev stearat (E 470b)
English: 400 mg twice daily
Croatian: 400 mg dvaput na dan
English: Dose normalized cyclosporine ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Croatian: Omjeri normalizirani za dozu ciklosporina prikazani su za interakciju s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
English: Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena s fluvastatinom i pitavastatinom (vidjeti dio
English: Genotype 1a, with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Croatian: Bolesnici s genotipom 1a, s kompenziranom cirozom dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
English: HCV Genotype 1b dasabuvir and ombitasvir/paritaprevir/ritonavir
Croatian: HCV genotipa 1b dasabuvir i ombitasvir/paritaprevir/ritonavir
English: GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (8 weeks)
Croatian: GT1b dasabuvir i ombitasvir/paritaprevir/ritonavir (8 tjedana)
English: Drug interaction studies
Croatian: Ispitivanja interakcija između lijekova
English: Genotype 1a, without cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Croatian: Bolesnici s genotipom 1a, bez ciroze dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
English: Concomitant use of tacrolimus with dasabuvir and ombitasvir/paritaprevir/ ritonavir is not recommended unless the benefits outweigh dasabuvir ombitasvir
Croatian: Istodobna primjena takrolimusa s dasabuvirom i ombitasvirom/paritaprevir om/ritonavirom se ne preporučuje osim ako
English: Other CYP2C9 substrates (NSAIDs (e.g. ibuprofen), antidiabetics (e.g. glimepiride, glipizide) are not expected to require dose adjustments.
Croatian: Za ostale supstrate za CYP2C9 (NSAIL-i (npr. ibuprofen), antidijabetici (npr.
English: Tel: +385 (0)1 5625 501
Croatian: AbbVie d.o.o. Tel: +385 (0)1 5625 501
English: Apalutamide, enzalutamide for prostate cancer ethinyloestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception gemfibrozil to lower cholesterol and other fats in the blood mitotane for some tumours of the adrenal glands rifampicin for bacterial infections
Croatian: gemfibrozil za snižavanje razine kolesterola i drugih masnoća u krvi mitotan za liječenje nekih tumora nadbubrežnih žlijezda rifampicin za liječenje bakterijskih infekcija gospina trava (Hypericum perforatum)
English: In Part 2, subjects with HCV GT1 received dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 weeks.
Croatian: U drugom su dijelu ispitanici s infekcijom HCV-om genotipa 1 primali dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna.
English: THYROID HORMONES Levothyroxin e
Croatian: TIROIDNI HORMONI Levotiroksi n
English: Serum ALT elevations
Croatian: Povišene razine ALT-a u serumu
English: Τηλ: +357 22 34 74 40
Croatian: Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40
English: Very common
Croatian: Od ukupno
English: Genotype 1b, without cirrhosis or with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir
Croatian: Bolesnici s genotipom 1b, bez ciroze ili s kompenziranom cirozom dasabuvir + ombitasvir/paritaprevir/ritonavir
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: Overall SVR12 HCV genotype 1a Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers HCV genotype 1b Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers Outcome for subjects without SVR12 On-treatment VF Relapse Other a. 97.5% confidence intervals are used for the primary efficacy endpoints (overall SVR12 rate); 95% confidence intervals are used for additional efficacy endpoints (SVR12 rates in HCV genotype 1a and 1b-infected subjects).
Croatian: Za primarnu mjeru ishoda za djelotvornost (ukupna stopa SVR12) koriste se intervali pouzdanosti od 97,5%; za dodatne mjere ishoda za djelotvornost (stope SVR12 u ispitanika s infekcijom HCV-om genotipa 1a i 1b) koriste se intervali pouzdanosti od 95%.
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Croatian: GT1a skupina A: dasabuvir i ombitasvir/paritaprevir/ritonavir + RBV skupina B: dasabuvir i ombitasvir/paritaprevir/ritonavir
English: CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments.
Croatian: metoprolol i dekstrometorfan) ne očekuje se potreba prilagodbe doze.
English: increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
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 HCV RNK od ≥ 25 IU/ml uz najmanje 6 tjedana liječenja.
English: Outcome for subjects without SVR12 On-treatment VF
Croatian: Ishodi za ispitanike bez SVR12 Virološki neuspjeh tijekom liječenja
English: Everolimus cannot be used due to lack of suitable dose strengths for dose adjustments.
Croatian: čija se doza ne može pravilno prilagoditi s dostupnim jačinama lijeka.
English: buprenorphin e/ naloxone 4-24 mg/16 mg once daily8
Croatian: 4-24 mg/1-6 mg jedanput na dan8
English: 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.
Croatian: C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a.
English: The pharmacokinetic properties of the combination of dasabuvir with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 18 shows mean Cmax and AUC of dasabuvir 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 18 navode se srednje vrijednosti Cmax i AUC-a dasabuvira 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: NA No dose adjustment for cyclobenzaprine required; increase dose if clinically indicated.
Croatian: NP Nije potrebno prilagođavati dozu za ciklobenzaprin; primijeniti veću dozu ako je to klinički indicirano.
English: Subjects with liver transplant and GT4 infection were dosed with ombitasvir/paritaprevir/ritonavir with RBV (noncirrhotic for 12 weeks [n=2] and cirrhotic for 24 weeks [n=1].
Croatian: Ispitanici s jetrenim transplantatom i infekcijom genotipom 4 primali su ombitasvir/paritaprevir/ritonavir u kombinaciji s RBV-om (bolesnici bez ciroze tijekom 12 tjedana
English: dasabuvir and ombitasvir/paritaprevir /ritonavir + ribavirin
Croatian: dasabuvir i ombitasvir/paritaprevir /ritonavir + ribavirin
English: Sirolimus 2 mg was dosed alone, 0.5 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Croatian: Sirolimus se u dozi od 2 mg primjenjivao sam, a u dozi od 0,5 mg s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
English: • Monitoring should be performed for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Croatian: • Potreban je nadzor zbog moguće pojave kliničkih znakova i simptoma dekompenzacije jetre
English: CYP3A/efflu x transporters by lopinavir and higher dose of ritonavir.
Croatian: povećanje izloženosti paritaprevir u moglo bi biti posljedica inhibicije CYP3A/eflu ksnih prijenosnika koju uzrokuju lopinavir i viša doza ritonavira.
English: Frequency dasabuvir and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
Croatian: Učestalost dasabuvir i ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2044
English: TURQUOISE II (open-label)
Croatian: ribavirin, s kompenziranom cirozom TURQUOISE II (otvoreno ispitivanje)
English: The activity of dasabuvir was reduced by 5- and 11-fold by C316N and S556G, respectively; 46-fold by M414T or Y448H; and 1569-fold by the C316Y substitutions in the genotype 1b replicon.
Croatian: U replikonu genotipa 1b, supstitucija C316N smanjila je aktivnost dasabuvira 5 puta, supstitucija S556G 11 puta, supstitucije M414T i Y448H 46 puta, a supstitucija C316Y 1569 puta.
English: Dabigatran etexilate Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir.
Croatian: Mehanizam: crijevna Pgp inhibicija paritaprevir om i ritonavirom.
English: Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Croatian: Medijan dobi liječenih ispitanika (N=380) iznosio je 58 godina (raspon: 21 do 71); 42,1% prethodno nije bilo liječeno; 36,1% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 8,2% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 13,7% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 70,3% ispitanika bili su muškarci; 3,2% bili su crnci; 14,7% imalo je broj trombocita manji od 90 x 109/l, 49,7% imalo je razinu albumina manju od 40 g/l; 86,1% imalo je početne razine HCV RNK od najmanje 800 000
English: The adverse reactions are listed below by system organ class and frequency.
Croatian: Nuspojave u nastavku razvrstane su prema organskim sustavima i učestalosti.
English: 0.75 mg single dose
Croatian: Everolimus 0,75 mg pojedinačna doza Mehanizam:
English: global multicentre, open-label
Croatian: globalno, multicentrično, otvoreno ispitivanje
English: Dose normalized tacrolimus ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Croatian: Omjeri normalizirani za dozu takrolimusa prikazani su za interakciju s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
English: TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Croatian: TURQUOISE-III: ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni kombinacijom pegIFN + RBV
English: ↔ ethinyl oestradiol
Croatian: KG Knollstrasse
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% were Black; 19% had compensated cirrhosis; 67% were treatment-naïve; 33% had failed prior treatment with pegIFN/RBV; 89% had HCV genotype 1a infection.
Croatian: (raspon: 31 do 69); 24% bili su crnci; 19% imalo je kompenziranu cirozu; 67% prethodno nije bilo liječeno; 33% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 89% imalo je infekciju HCV-om genotipa 1a.
English: PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis Design:
Croatian: PEARL-II - ispitanici s infekcijom genotipom 1b prethodno liječeni kombinacijom pegIFN+RBV, bez ciroze
English: Ciclosporin 100 mg dosed alone and 30 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Croatian: Samostalna doza od 100 mg ciklosporina ili doza od 30 mg ciklosporina primijenjena s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
English: DIURETICS Furosemide 20 mg single dose
Croatian: 20 mg pojedinačna doza
English: Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser Outcome for subjects without SVR12 On-treatment VF
Croatian: Relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV Ishodi za ispitanike bez SVR12
English: NS5A M28T M28Ve
Croatian: NS5B A553T
English: The highest documented single dose of dasabuvir administered to healthy volunteers was 2 g. No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed.
Croatian: 2 g. Nisu zabilježene nuspojave povezane s primjenom ispitivanoga lijeka ni klinički značajna odstupanja u laboratorijskim vrijednostima..
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Croatian: Mehanizam: mogao bi biti posljedica inhbicije UGT1A1 koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
English: Methadone
Croatian: Metformin
English: Genotype-specific activity
Croatian: Aktivnost protiv pojedinih genotipova
English: Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
Croatian: Mehanizam: paritaprevir inhibira OATP1B, a dasabuvir, paritaprevir, ritonavir inhibiraju BCRP.
English: Resistance-associated variants at amino acid positions R155 and D168 in NS3 were rarely observed (less than 1%) at baseline.
Croatian: Varijante na aminokiselinskim položajima R155 i D168 u NS3,
English: dasabuvir and ombitasvir/paritaprevir/ritonavir without ribavirin for 12 weeks
Croatian: dasabuvir i ombitasvir/paritaprevir/ritonavir tijekom 12 tjedana, bez ribavirina
English: randomised, global multicentre, open-label, regimen-controlled
Croatian: randomizirano, globalno, multicentrično, otvoreno ispitivanje kontrolirano terapijskim režimom
English: Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Croatian: Mehanizam: mogao bi biti posljedica inhibicije UGT-a koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
English: AbbVie d.o.o.
Croatian: AbbVie B.V.
English: 800/160 mg twice daily dasabu vir +
Croatian: 800/160 mg dvaput na dan
English: ANTIMYCOBACTERIALS Rifampicin
Croatian: ANTIKONVULZIVI karbamazepin
English: Tacrolimus 2 mg was dosed alone and 2 mg was administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Croatian: Samostalna doza od 2 mg takrolimusa i doza od 2 mg primijenjena s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
English: AbbVie B.V. Tel: +31 (0)88 322 2843
Croatian: Tel: +31 (0)88 322 2843
English: Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
Croatian: R155K ili D168V u NS3 nastale tijekom primjene paritaprevira primijećene su u 47 ispitanika.
English: Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Croatian: Mehanizam: ritonavir inhibira CYP3A4 a paritaprevir, ombitasvir i dasabuvir inhibiraju UGT.
English: ↑ fluvastatin ↑ pitavastatin ↔ dasabuvir ↔ ombitasvir ↔ paritaprevir
Croatian: ↑ darunavir ↓ dasabuvir ombitasvir
English: HCV Genotype 1a dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV
Croatian: HCV genotipa 1a dasabuvir i ombitasvir/paritaprevir/ritonavir
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir aprevir/ ritonavi r ombitasvir
Croatian: Mehanizam: CYP3A4 inhibicija ritonavirom ombitasvir/p aritaprevir/ri tonavir
English: Poly(vinyl alcohol) (E 1203) Titanium dioxide (E 171) Macrogol (3350) Talc (E 553b)
Croatian: poli(vinilni alkohol) (E 1203) titanijev dioksid (E 171) makrogol (3350) talk (E 553b) željezov oksid, žuti (E 172) željezov oksid, crveni (E 172) željezov oksid, crni (E 172)
English: Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders; and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; ; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Croatian: Medijan dobi liječenih ispitanika (N=179) iznosio je 57 godina (raspon: 26 do 70); 35,2% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 28,5% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 36,3% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 54,2% ispitanika bili su muškarci; 3,9% bili su crnci; 12,8% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,7% imalo je početne razine
English: Pravastatin 10 mg once daily
Croatian: 10 mg jedanput na dan
English: Tell your doctor or pharmacist if you notice any of the following side effects: Side effects when taking Exviera with ombitasvir/paritaprevir/ritonavir:
Croatian: Recite svom liječniku ako imate sljedeće simptome tijekom uzimanja lijeka Exviera i ombitasvira/paritaprevira/ritonavira jer oni mogu biti znakovi pogoršanja jetrenih tegoba:
English: TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Croatian: TURQUOISE-II - ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni kombinacijom pegIFN + RBV
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: Ukupan SVR12 HCV genotipa 1a HCV genotipa 1b Ishodi za ispitanike bez SVR12
English: randomised, global multicentre, open-label
Croatian: randomizirano, globalno, multicentrično, otvoreno ispitivanje