FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing ombitasvir, paritaprevir, and dasabuvir with or without ribavirin (for 8, 12, or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Croatian: Od 2510 ispitanika s infekcijom HCV-om genotipa 1 koji su u kliničkim ispitivanjima faze 2b i 3 liječeni režimima koji su sadržavali ombitasvir, paritaprevir i dasabuvir, u kombinaciji s ribavirinom ili bez njega (tijekom 8, 12 ili 24 tjedna), ukupno je njih 74 (3%) doživjelo virološki neuspjeh
English: Treatment-naïve Without RBV
Croatian: Prethodno neliječeni bez RBV-a
English: Genotype 1b, without cirrhosis or with compensated cirrhosis
Croatian: Bolesnici s genotipom 1b, bez ciroze ili s kompenziranom cirozom
English: Viekirax is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.2, 4.3, 4.8 and 5.2).
Croatian: Viekirax je kontraindiciran u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (Child-Pugh stadij B ili C) (vidjeti dijelove 4.2, 4.3, 4.8 i 5.2).
English: Medicinal products metabolised by CYP2C19
Croatian: Lijekovi koji se metaboliziraju posredstvom CYP2C19
English: 200 mg once daily followed by 200 mg twice daily
Croatian: 200 mg jedanput na dan, a potom 200 mg dvaput na dan
English: Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Croatian: Viekirax 12,5 mg/75 mg/50 mg filmom obložene tablete
English: Treated subjects (N = 233) had a median age of 49 years (range: 26 to 69); 10% were Black; 12% had compensated cirrhosis; 66% were treatment-naïve; 32% had failed prior treatment with pegIFN/RBV; 2% had failed prior treatment with sofosbuvir.
Croatian: Medijan dobi liječenih ispitanika (N = 233) iznosio je 49 godina (raspon: 26 do 69); 10% bili su crnci; 12% imalo je kompenziranu cirozu; 66% prethodno nije bilo liječeno; 32% bilo je prethodno neuspješno liječeno pegIFN/RBV-om; 2% bilo je prethodno neuspješno liječeno sofosbuvirom.
English: In genotype 1b, substitutions L28T, L31F/V, as well as Y93H alone or in combination with L28M, R30Q, L31F/M/V or P58S in HCV NS5A reduced susceptibility to ombitasvir.
Croatian: Kod genotipa 1b, supstitucije L28T, L31F/V, kao i Y93H samostalno ili u kombinaciji s L28M, R30Q, L31F/M/V ili P58S u proteinu NS5A HCV-a smanjile su osjetljivost na ombitasvir.
English: In genotype 1a, substitutions M28T/V, Q30E/R, L31V, H58D, Y93C/H/N, and M28V + Q30R in HCV NS5A reduced susceptibility to ombitasvir.
Croatian: Kod genotipa 1a, supstitucije M28T/V, Q30E/R, L31V, H58D, Y93C/H/N i M28V + Q30R u proteinu NS5A HCV-a smanjile su osjetljivost na ombitasvir.
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Viekirax with or without dasabuvir is required.
Croatian: Preporučuje se smanjnjenje doze ili prekid liječenja kolhicinom u bolesnika s normalnom funkcijom bubrega ili jetre ukoliko je potrebno liječenje lijekom
English: Ombitasvir-derived material was minimally transferred through the placenta in pregnant rats.
Croatian: Tvari potekle od ombitasvira u minimalnoj su mjeri prolazile kroz placentu skotnih ženki štakora.
English: In the genotype 1a replicon, the activity of ombitasvir was reduced by 896-, 58- and 243-fold against the M28T/V and H58D substitutions, respectively, and 1326-, 800-, 155-foldand 1675- to 66740- fold by the Q30E/R, L31V and Y93C/H/N substitutions, respectively.
Croatian: U replikonu genotipa 1a, aktivnost ombitasvira bilo je 896 puta manje protiv supstitucije M28T, 58 puta manje protiv supstitucije M28V, 243 puta manje protiv supstitucije H58D, 1326 puta manje protiv supstitucije Q30E, 800 puta manje protiv supstitucije Q30R, 155 puta manje protiv supstitucije L31V, te 1675 do 66 740 puta manje protiv supstitucija Y93C/H/N.
English: Genotype 4, without cirrhosis or with compensated cirrhosis
Croatian: Bolesnici s genotipom 4, bez ciroze ili s kompenziranom cirozom
English: Nifedipine Mechanism: CYP3A4 inhibition
Croatian: Nifedipin Mehanizam : Inhibicija CYP3A4
English: In the genotype 1a replicon, the activity of paritaprevir was reduced 20-, 37-, and 17-fold by the F43L, R155K and A156T substitutions, respectively.
Croatian: U replikonu genotipa 1a, supstitucija F43L smanjila je aktivnost paritaprevira 20 puta, supstitucija R155K 37 puta, a supstitucija A156T 17 puta.
English: Monitor ciclosporin levels and adjust dose and/or dosing frequency as needed.
Croatian: Pratiti razine ciklosporina te po potrebi prilagoditi dozu i/ili učestalost primjene.
English: In genotype 1a, substitutions F43L, R155K, A156T, and D168A/F/H/V/Y in HCV NS3 reduced susceptibility to paritaprevir.
Croatian: Kod genotipa 1a, supstitucije F43L, R155K, A156T i D168A/F/H/V/Y u proteinu NS3 HCV-a smanjile su osjetljivost na paritaprevir.
English: Medicinal products metabolised by CYP2C9
Croatian: Lijekovi koji se metaboliziraju posredstvom CYP2C9
English: Table 19.
Croatian: Tablica 19.
English: If tacrolimus with Viekirax and dasabuvir are used concomitantly, tacrolimus should not be administered on the day Viekirax and dasabuvir are initiated.
Croatian: Viekirax i dasabuvirom, takrolimus se ne smije primijeniti na dan kada se uvode Viekirax i dasabuvir.
English: In subjects with mild hepatic impairment, paritaprevir, ritonavir and ombitasvir mean Cmax and AUC values decreased by 29% to 48%, 34% to 38% and up to 8%, respectively, compared to subjects with normal hepatic function.
Croatian: U ispitanika s blagim oštećenjem funkcije jetre, srednje vrijednosti Cmax i AUC-a paritaprevira, ritonavira odnosno ombitasvira smanjile su se za 29% do 48%, 34% do 38% odnosno do 8%, u usporedbi s ispitanicima s normalnom funkcijom jetre.
English: Subjects with HCV GT4 received Viekirax with ribavirin for 12 or 24 Weeks.
Croatian: Ispitanici s infekcijom HCV-om genotipa 4 primali su Viekirax u kombinaciji s ribavirinom tijekom 12 ili 24 tjedna.
English: NA No dose adjustment is necessary for zolpidem.
Croatian: Nije potrebno prilagođavati dozu za zolpidem.
English: 800/100 mg once daily
Croatian: 800/100 mg jedanput na dan
English: These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin, lomitapide 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 apalutamide,enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinyloestradiol-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)
Croatian: Ti lijekovi mogu biti dostupni i bez recepta. atorvastatin, lovastatin, simvastatin, lomitapid za snižavanje razine kolesterola u krvi karbamazepin, fenitoin, fenobarbital za liječenje epilepsije cisaprid za ublažavanje određenih želučanih tegoba klaritromicin, fusidatna kiselina, rifampicin, telitromicin za liječenje bakterijskih infekcija kolhicin u bolesnika koji imaju teške tegobe s jetrom ili bubrezima za liječenje napadaja gihta konivaptan za reguliranje razine natrija u krvi efavirenz, etravirin, lopinavir/ritonavir, sakvinavir, tipranavir, nevirapin, indinavir, kobicistat za liječenje HIV infekcije apalutamid, enzalutamid za liječenje karcinoma prostate ergotamin, dihidroergotamin za liječenje migrenskih glavobolja ergonovin, metilergometrin lijekovi koji se koriste pri porodu lijekovi koji sadrže etinilestradiol koji se nalazi u većini kontracepcijskih tableta i vaginalnim prstenovima koji se koriste za kontracepciju za kontracepciju itrakonazol, ketokonazol, posakonazol, vorikonazol za liječenje gljivičnih infekcija midazolam, triazolam (kada se uzimaju kroz usta)
English: Paritaprevir -derived material was minimally transferred through the placenta in pregnant rats.
Croatian: Tvari potekle od paritaprevira u minimalnoj su mjeri prolazile kroz placentu skotnih ženki štakora.
English: HCV Genotype 1a Viekirax and dasabuvir with RBV
Croatian: HCV genotipa 1a Viekirax i dasabuvir s RBV-om
English: 13/15 (86.7)c a. Calculated using the normal approximation to the binomial distribution b. 1 patient discontinued due to non-compliance c. Relapse in 2/15 patients (confirmed HCV RNA ≥ 15 IU/mL post-treatment before or during SVR12 window among subjects with HCV RNA < 15 IU/mL at last observation with at least 51 days of treatment).
Croatian: Relaps u 2/15 bolesnika (potvrđena razina HCV RNK nakon liječenja od ≥ 15 IU/ml prije ili tijekom razdoblja određivanja SVR12, među ispitanicima koji su imali HCV RNK < 15 IU/ml na zadnjem mjerenju uz najmanje 51 dan liječenja).
English: Concomitant use of sirolimus with Viekirax and dasabuvir is not recommended unless the benefits outweigh the risks
Croatian: Istodobna primjena takrolimusa s lijekom Viekirax i dasabuvirom se ne preporučuje osim ako koristi ne nadmašuju rizike ombitasvir
English: Clinical trials in subjects with genotype 4 chronic hepatitis C
Croatian: Klinička ispitivanja u ispitanika s infekcijom virusom hepatitisa C genotipa 1
English: Interactions between Viekirax with or without dasabuvir and other medicinal products
Croatian: Tablica 2. Interakcije između lijeka Viekirax, s dasabuvirom ili bez njega, i drugih lijekova
English: The recommended dose of darunavir is 800 mg once daily, without ritonavir, when administered at the same time as Viekirax + dasabuvir (ritonavir dose in Viekirax will provide darunavir pharmacokinetic enhancement).
Croatian: Preporučena doza darunavira je 800 mg jedanput na dan, bez ritonavira, kada se primjenjuje u isto vrijeme s lijekom Viekirax s dasabuvirom (doza ritonavira sadržana u lijeku
English: Pack-size of 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Croatian: Pakiranje od 56 tableta (višestruko pakiranje sadrži 4 unutarnje kutije, od kojih svaka ima 14 tableta).
English: The activity of ombitasvir was reduced by 661-, 77-, 284- and 142-fold against the genotype 1b substitutions L28T, Y93H, R30Q in combination with Y93H, and L31M in combination with Y93H, respectively.
Croatian: Kod genotipa 1b, aktivnost ombitasvira bilo je 661 puta manje protiv supstitucije L28T, 77 puta manje protiv supstitucije Y93H, 284 puta manje protiv supstitucije R30Q u kombinaciji s Y93H te 142 puta manje protiv supstitucije L31M u kombinaciji s Y93H.
English: Tacrolimus or sirolimus whole blood concentrations should be monitored upon initiation and throughout co-administration with Viekirax and dasabuvir and the dose and/or dosing frequency should be adjusted as needed.
Croatian: Potrebno je pratiti koncentracije takrolimusa u punoj krvi nakon započinjanja i tijekom cijelog razdoblja istodobne primjene s lijekom Viekirax i dasabuvirom te po potrebi prilagođavati dozu i/ili učestalost doziranja.
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Viekirax and dasabuvir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Croatian: U ispitanika koji su primali lijekove Viekirax i dasabuvir u kombinaciji s ribavirinom 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: Effect of dasabuvir on paritaprevir/ritonavir and ombitasvir
Croatian: Učinak dasabuvira na paritaprevir/ritonavir i ombitasvir
English: Ombitasvir had no effect on fertility when evaluated in mice.
Croatian: U ispitivanjima na miševima, ombitasvir nije utjecao na plodnost.
English: In subjects with liver transplant, no cirrhosis and GT1 infection, patients were dosed with Viekirax and dasabuvir for 12-24 weeks, with and without RBV.
Croatian: Ispitanici s jetrenim transplantatom i infekcijom genotipom 1 bez ciroze primali su Viekirax i dasabuvir tijekom 12 - 24 tjedna, u kombinaciji s RBV-om ili bez njega.
English: TURQUOISE-II: Relapse Rates by Baseline Laboratory Values after 12 and 24 Weeks of Treatment in Subjects with Genotype 1a Infection and Compensated Cirrhosis
Croatian: Stope relapsa u odnosu na početne laboratorijske vrijednosti u ispitanika s infekcijom genotipom 1a i kompenziranom cirozom nakon 12 i 24 tjedna liječenja Viekirax i dasabuvir s RBV-om
English: Treatment-emergent amino acid substitutions in the pooled analysis of Viekirax and dasabuvir with and without RBV regimens in Phase 2b and Phase 3 clinical trials (N=2510)
Croatian: Tablica 5. Aminokiselinske supstitucije nastale tijekom liječenja primijećene u analizi objedinjenih podataka za režime liječenja lijekovima Viekirax i dasabuvir s RBV-om ili bez njega, u kliničkim ispitivanjima faze 2b i faze 3 (N=2510)
English: Tél/Tel: +32 10 477811
Croatian: Belgique/Belgien Tél/Tel: +32 10 477811
English: *Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
Croatian: 12 tjedana * Napomena: Za bolesnike s infekcijom genotipom 1 nepoznatog podtipa ili mješovitom infekcijom genotipom 1, treba slijediti preporuke za doziranje za genotip 1a.
English: Relapse
Croatian: Relaps
English: In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Croatian: Učinak prilagodbe doze ribavirina na vjerojatnost postizanja SVR-a U kliničkim ispitivanjima faze 3, u 91,5% ispitanika nije bilo potrebno prilagođavati dozu ribavirina tijekom terapije.
English: The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively.
Croatian: U testu replikona HCV-a u staničnoj kulturi, srednja vrijednost EC50 paritaprevira protiv replikona koji sadrže NS3 iz palete izolata genotipa 1a odnosno 1b prikupljenih u prethodno neliječenih ispitanika iznosila je 0,86 nM (raspon: 0,43 do 1,87 nM; n=11) odnosno 0,06 nM (raspon: 0,03 do 0,09 nM; n=9).
English: Itraconazole Posaconazole
Croatian: itrakonazol posakonazo l
English: NA ↔ ombitasvir/paritaprevir/dasabuvir (based on the crossstudy comparison)
Croatian: ↔ paritaprevir/ombitasvir/dasabuvir (na temelju usporedbe podataka iz različitih ispitivanja)
English: Paritaprevir had an EC50 value of 5.3 nM against the 2a-JFH-1 replicon cell line, and EC50 values of 19, 0.09, and 0.68 nM against replicon cell lines containing NS3 from a single isolate each of genotype 3a, 4a, and 6a, respectively
Croatian: Vrijednost EC50 paritaprevira protiv stanične linije replikona 2a-JFH-1 iznosila je 5,3 nM, dok su vrijednosti EC50 protiv staničnih linija replikona koji su sadržavali NS3 iz po jednog izolata genotipa 3a, 4a odnosno 6a iznosile 19; 0,09 odnosno 0,68 nM.
English: Expected in CYP2C19 Poor Metabolisers:
Croatian: Očekuje se u CYP2C19 sporih metabolizatora:
English: Propylene glycol monolaurate Sorbitan monolaurate Colloidal anhydrous silica (E 551) Sodium stearyl fumarate
Croatian: kopovidon tokofersolan propilenglikolmonolaurat sorbitanmonolaurat silicijev dioksid, koloidni, bezvodni (E 551) natrijev stearilfumarat
English: 200 mg once daily/300 mg once daily
Croatian: 200 mg jedanput na dan/300 mg jedanput na dan
English: treatment naïve: Viekirax without ribavirin or with weight-based ribavirin for 12 weeks pegIFN + RBV experienced: Viekirax with weight-based ribavirin for 12 weeks
Croatian: prethodno neliječeni ispitanici: Viekirax tijekom 12 tjedana bez ribavirina ili s ribavirinom čija je doza temeljena na težini ispitanici prethodno liječeni pegIFN i RBV: Viekirax tijekom 12 tjedana s ribavirinom čija je doza temeljena na težini
English: Viekirax may be administered with or without dasabuvir.
Croatian: Viekirax se može primjenjivati s dasabuvirom ili bez njega.
English: Medicinal products transported by P-gp in the intestine While paritaprevir, ritonavir and dasabuvir are in vitro inhibitors of P-gp, no significant change was observed in the exposure of the P-gp substrate digoxin when administered with Viekirax and dasabuvir.
Croatian: Iako su paritaprevir, ritonavir i dasabuvir inhibitori P-gp-a in vitro, nije primijećena značajna promjena izloženosti digoksinu, supstratu za P-gp, kada se primjenjivao istodobno s lijekom Viekirax i dasabuvirom.
English: paritaprevir recommended.
Croatian: paritaprevir do 50%.
English: 300 mg single dose
Croatian: 300 mg pojedinačna doza
English: 800/160 mg twice daily
Croatian: 800/160 mg dvaput na dan
English: Expected: ↑ ergot derivatives
Croatian: ↑ ergot derivati
English: Ciclosporin 100 mg dosed alone, 10 mg administered with Viekirax and 30 mg administered with Viekirax + dasabuvir.
Croatian: Ciklosporin od 100 mg primijenjen sam, od 10 mg primijenjen s lijekom Viekirax i od 30 mg primijenjen s lijekom Viekirax + dasabuvir.
English: Ranolazine
Croatian: ↑ ranolazin
English: Viekirax and dasabuvir without ribavirin for 12 weeks 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
Croatian: 60 je bolesnika bilo randomizirano i liječeno te je 60/60 (100%) postiglo SVR12.
English: Side effects when taking Viekirax with dasabuvir:
Croatian: Nuspojave koje se javljaju kada se Viekirax uzima s dasabuvirom:
English: Erythromycin
Croatian: eritromicin
English: No dose adjustment needed for Viekirax.
Croatian: Nije potrebna prilagodba doze za lijek Viekirax.
English: Yes (for all three parameters listed above) No (for any parameter listed above) *AFP= serum alpha fetoprotein In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Croatian: U ispitanika koji su prije početka ispitivanja imali povoljne vrijednosti za sva tri parametra (AFP < 20 ng/ml, broj trombocita ≥ 90 x 109/l i albumin ≥ 35 g/l), stope relapsa bile su slične kod ispitanika iz skupine koja je liječena 12 tjedana kao i kod ispitanika iz skupine koja je liječena 24 tjedna.
English: 600/300 mg once daily
Croatian: 600/300 mg jedanput na dan
English: Duloxetine 60 mg single dose
Croatian: paritaprevir duloksetin pojedinačna doza od 60 mg
English: Potent inhibitors of P-gp, BCRP, OATP1B1 and/or OATP1B3 have the potential to increase the exposure to paritaprevir.
Croatian: Lijekovi koji inhibiraju prijenosne proteine Snažni inhibitori P-gp-a, BCRP-a, OATP1B1 i/ili OATP1B3 mogu povećati izloženost paritapreviru.
English: ↑ fusidic acid
Croatian: fusidatna kiselina
English: Genotype 1a, without cirrhosis
Croatian: Bolesnici s genotipom 1a, bez ciroze
English: Paritaprevir/ritonavir has shown malformations (open eye lids) at a low incidence in mice at exposures 32/8-fold higher than the exposure in humans at the recommended clinical dose.
Croatian: U ispitivanjima na miševima, uočene su malformacije vjeđa (otvorene vjeđe, engl. open eyelid) s malom incidencijom pri izloženostima paritapreviru/ritonaviru 32/8 puta većima od izloženosti koja se postiže u ljudi pri preporučenoj kliničkoj dozi.
English: Not studied; No interaction expected when gemfibrozil is used in combination with Viekirax without dasabuvir.
Croatian: Ne očekuje se interakcija pri primjeni gemfibrozila u kombinaciji s lijekom Viekirax bez dasabuvira.
English: • fusidic acid
Croatian: • fusidatna kiselina
English: Sirolimus 0.5 mg single dose5
Croatian: Sirolimus 0,5 mg pojedinačna doza5 Mehanizam:
English: Geometric mean Cmax, AUC of multiple doses of Viekirax 150 mg/100 mg/25 mg once daily with dasabuvir 250 mg twice daily with food in healthy volunteers
Croatian: Geometrijske srednje vrijednosti Cmax i AUC-a nakon višekratnih doza lijeka Viekirax 150 mg/100 mg/25 mg jedanput na dan i dasabuvira 250 mg dvaput na dan primijenjenih s hranom u zdravih dobrovoljaca
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg were not evaluated in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (ChildPugh 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 nije ocijenjena u ispitanika s blagim (Child-Pugh stadij A), umjerenim (Child-Pugh stadij B) i teškim (Child-Pugh stadij C) oštećenjem funkcije jetre.
English: (≤25% difference in the Least Square Means ratio) for Viekirax with or without dasabuvir, unless otherwise noted.
Croatian: Jačina interakcija pri istodobnoj primjeni s lijekovima navedenima u Tablici 2 slična je (razlika u omjeru srednje vrijednosti dobivenih metodom najmanjih kvadrata ≤ 25%) za Viekirax s dasabuvirom ili bez njega, osim ako nije drugačije naznačeno.
English: RUBY-I; treatment-naïve or pegIFN + RBV experienced with or without cirrhosis who have severe renal impairment or end stage renal disease (ESRD)
Croatian: RUBY-I; ispitanici s cirozom ili bez nje, prethodno neliječeni ili prethodno liječeni pegIFN i RBV koji imaju teško oštećenje funkcije bubrega ili završni stadij bubrežne bolesti Dizajn:
English: • quetiapine
Croatian: • kvetiapin
English: Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong or moderate enzyme inducers is expected to decrease ombitasvir, paritaprevir, and ritonavir plasma concentrations and reduce their therapeutic effect and must not be co-administered (see section 4.5).
Croatian: Istodobna primjena lijeka Viekirax, s dasabuvirom ili bez njega, s lijekovima koji su snažni ili umjereni induktori enzima, može sniziti koncentracije ombitasvira, paritaprevira i ritonavira u plazmi i smanjiti njihov terapijski učinak pa se ne smiju uzimati istodobno (vidjeti dio 4.5).
English: Viekirax + dasabuvir atazanavir ombitasvir paritaprevir
Croatian: Viekirax + dasabuvir atazanavir ombitasvir paritaprevir dasabuvir
English: In Part 2, subjects with HCV GT1 received Viekirax and dasabuvir with or without ribavirin for 12 or 24 weeks.
Croatian: U drugom su dijelu ispitanici s infekcijom HCV-om genotipa 1 primali Viekirax i dasabuvir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna.
English: Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir
Croatian: Viekirax 12,5 mg / 75 mg / 50 mg tablete ombitasvir / paritaprevir / ritonavir
English: Transient increases in indirect bilirubin were observed at the highest doses of paritaprevir/ritonavir.
Croatian: Pri najvišim dozama paritaprevira/ritonavira zabilježeno je prolazno povišenje razina indirektnog bilirubina.
English: The persistence of paritaprevir, ombitasvir, and dasabuvir resistance-associated amino acid substitutions in NS3, NS5A, and NS5B, respectively, was assessed in genotype 1a-infected subjects in Phase 2b trials.
Croatian: Postojanost aminokiselinskih supstitucija u NS3, NS5A odnosno NS5B povezanih s rezistencijom na paritaprevir, ombitasvir odnosno dasabuvir ocijenjena je u ispitanika s infekcijom genotipom 1a u kliničkim ispitivanjima faze 2b.
English: GIVEN WITH
Croatian: PRIMIJENJEN UZ
English: ↑ fluvastatin ↑ pitavastatin
Croatian: Očekuje se: ↑ fluvastatin ↑ pitavastatin
English: Possible side effects
Croatian: mogući mehanizam interakcije