natgillin/translations-raw huggingface dataset:
The pharmacokinetics of telaprevir were assessed after administration of a single dose of 750 mg to HCV-negative subjects with severe renal impairment (CrCl < 30 ml/min).
Farmakokinetika telaprevira procijenila se nakon primjene jednokratne doze od 750 mg u HCV negativnih ispitanika s teškim oštećenjem funkcije bubrega (CrCl < 30 ml/min).
In clinical trials, the majority of these events (e.g., haemorrhoids, anorectal discomfort, anal pruritus, and rectal burning) were mild to moderate, very few led to treatment discontinuation and resolved after completion of INCIVO dosing.
U kliničkim je ispitivanjima većina ovih događaja (npr. hemoroidi, anorektalna nelagoda, analni svrbež i rektalno žarenje) bila blaga do umjerena, dok su u vrlo malog broja bolesnika doveli do prestanka liječenja i povukli se nakon završetka primjene INCIVA.
Telaprevir readily crosses the placenta in both rat and mouse giving a foetal: maternal exposure of 19 - 50%.
Telaprevir lako prolazi posteljicu u štakora i miša, čime omjer izloženosti fetusa i majke iznosi od 19% do 50%.
Telaprevir is a weak in vitro inhibitor of the transporters multidrug and toxin extrusion (MATE) MATE1 and MATE2-K with an IC50 of 28.3 μM and 32.5 μM, respectively.
In vitro, telaprevir je slab inhibitor transportera više lijekova i toksina ekstruzije (MATE) MATE1 i MATE2-K uz IC50 od 28,3 μM odnosno 32,5 μM.
In a fertility and early embryonic development study in rats, an increase in non-viable conceptuses was observed.
U ispitivanjima utjecaja na plodnost i rani embrionalni razvoj u štakora primijećeno je povećanje neživih zametaka.
Toxic epidermal necrolysis (TEN) including fatal outcome has been observed in post-marketing experience (see section 4.8).
Toksična epidermalna nekroliza (TEN), uključujući onu s fatalnim ishodom, zabilježena je nakon stavljanja lijeka u promet (vidjeti dio 4.8).
clarithromycin, erythromycin, telithromycin, troleandomycin to treat bacterial infections (antibacterials)
klaritromicin, eritromicin, telitromicin, troleandomicin za liječenje bakterijskih infekcija (antibiotici)
No relevant inhibition by telaprevir of the organic cation transporter (OCT) OCT2 was observed in vitro.
In vitro nije zabilježena relevantna inhibicija organskih kation transportera (OCT) OCT2 telaprevirom.
Of the 393 resistant variants detected in the 255 patients, 68% of NS3-36, 84% of NS3-54, 59% of NS3-155, 86% of NS3-156, and 52% of NS3-36M+NS3-155K variants were no longer detected.
Od 393 rezistentne varijante otkrivene u 255 bolesnika, više se nije moglo otkriti 68% NS3-36, 84% NS3-54, 59% NS3-155, 86% NS3-156 i 52% NS3-36M+NS3-155K varijanti.
In vitro studies demonstrated that telaprevir is not an inhibitor of UGT1A9 or UGT2B7.
In vitro ispitivanja su pokazala da telaprevir ne inhibira UGT1A9 ili UGT2B7.
Interruption of ribavirin may be required sooner if the rash worsens despite discontinuation of telaprevir.
Primjenu ribavirina treba prekinuti i prije ako se osip nastavi pogoršavati unatoč prekidu primjene telaprevira.
Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment.
Teške, potencijalno po život opasne i fatalne kožne reakcije prijavljene su uz kombinirano liječenje s lijekom INCIVO.
Syncope and retinopathy have been reported in some patients taking INCIVO and should be considered when assessing a patient's ability to drive or operate machines.
U nekih bolesnika koji uzimaju INCIVO zabilježene su sinkopa i retinopatija, koje treba uzeti u obzir kad se procjenjuje bolesnikova sposobnost upravljanja vozilima i rada sa strojevima.
The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia (see section 4.4).
Ova kombinacija može rezultirati povećanim rizikom kardiovaskularnih nuspojava povezanih sa salmeterolom, uključujući produljenje QT intervala, palpitacije i sinusnu tahikardiju (vidjeti dio 4.4).
You should contact your doctor immediately if you develop a rash or have a rash that gets worse.
Odmah se trebate javiti liječniku ako dobijete osip ili vam se osip pogorša.
astemizole, terfenadine to treat allergy symptoms (antihistamines)
astemizol, terfenadin za liječenje simptoma alergija (antihistaminici)
The clinical relevance of this is uncertain as administration of telaprevir with a single dose of buprenorphine, a partial UGT1A3 substrate, to healthy adult subjects did not result in increases in buprenorphine exposures.
Klinički značaj ovog nalaza nije siguran, obzirom da primjena telaprevira s jednom dozom buprenorfina, djelomičnog supstrata UGT1A3, zdravim odraslim ispitanicima nije dovela do povećene izloženosti buprenorfinu.
only includes data on patients who had week 4 HCV RNA available
Uključuje samo bolesnike za koje su bili dostupni podaci o HCV RNK u 4. tjednu
Fertility INCIVO had no effects on fertility or fecundity when evaluated in rats.
Plodnost INCIVO nije imao učinaka na plodnost ni oplodnju kada se ispitivao u štakora.
During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception.
Za to vrijeme, bolesnice reproduktivne dobi trebaju koristiti dvije učinkovite nehormonske metode kontracepcije.
When INCIVO is used in patients with advanced liver disease very close monitoring and early management of adverse events is recommended.
Kada INCIVO uzimaju bolesnici s uznapredovalom bolešću jetre, preporučen je strogi nadzor i rano zbrinjavanje
In patients who have an inadequate viral response, treatment should be discontinued (see sections 4.2 and 4.4, Laboratory tests).
Liječenje treba prekinuti u bolesnika koji imaju neodgovarajući virusni odgovor (vidjeti dijelove 4.2 i 4.4, Laboratorijske pretrage).
Telaprevir has not been tested for its carcinogenic potential.
Kancerogeni potencijal telaprevira nije ispitivan.
All patients N = 74 % (n/N)
Svi bolesnici N = 74 % (n/N)
Telaprevir-resistant variants were tested for cross-resistance against representative protease inhibitors in the HCV replicon system.
Za varijante rezistentne na telaprevir bila je ispitana ukrižena rezistencija na reprezentativne inhibitore proteaze u HCV replikonskom sustavu.
In patients with normal renal and hepatic function, an interruption of colchicine treatment is recommended, or only a limited colchicine treatment course at a reduced colchicine dose should be used.
U bolesnika s normalnom funkcijom bubrega ili jetre, preporučuje se prekid liječenja kolhicinom ili primjena samo kratke kure liječenja smanjenom dozom kolhicina.
In an HCV subtype 1b replicon assay, the telaprevir IC50 value against wild-type HCV was 0.354 µM similar to a subtype 1a infectious virus assay IC50 of 0.28 µM.
U testu replikona HCV-a podtipa 1b, IC50 vrijednost telaprevira protiv divljeg tipa HCV-a od 0,354 µM, bila je slična IC50 vrijednosti od 0,28 µM u testu s infektivnim virusom podtipa 1a.
The total duration of treatment of peginterferon alfa and ribavirin varies from 24 to 48 weeks depending on treatment response and whether you have been treated before.
Ukupno trajanje liječenja peginterferonom alfa i ribavirinom varira od 24 do 48 tjedana, ovisno o terapijskom odgovoru i o tome jeste li se već prije liječili.
Increase in thyroid stimulating hormone (TSH) may occur during INCIVO combination treatment, which may indicate worsening or recurrence of pre-existing or previous hypothyroidism, or new-onset hypothyroidism (see section 4.8).
Tijekom kombiniranog liječenja INCIVOM može se povisiti koncentracija tiroidnog stimulirajućeg hormona (TSH), što može ukazivati na pogoršanje postojeće ili povratak prethodne hipotireoze ili novonastalu hipotireozu (vidjeti dio 4.8).
Histopathological findings in the liver were similar in both rat and dog studies, of which not all were fully resolved after recovery.
Patohistološki nalazi jetre u ispitivanjima na štakorima i onima na psima bili su slični, s tim da se nisu svi povukli nakon oporavka.
In the analysis of an additional study, Study C211, the safety profile of combination therapy with INCIVO 1,125 mg twice daily was similar to the safety profile for patients receiving combination therapy with INCIVO 750 mg every 8 hours.
U analizi dodatnog ispitivanja, Ispitivanja C211, sigurnosni profil kombiniranog liječenja s lijekom INCIVO 1125 mg dva puta na dan bio je sličan sigurnosnom profilu za bolesnike koji primaju kombinirano liječenje s lijekom INCIVO 750 mg svakih 8 sati.
Concomitant use may lead to adverse events such as nausea, dizziness, hypotension and syncope.
Istodobna primjena može dovesti do nuspojava kao što su mučnina, omaglica, hipotenzija i sinkopa.
If improvement is not observed within 7 days of INCIVO discontinuation, sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon alfa should be considered.
Ako se ne primijeti poboljšanje unutar 7 dana nakon prekida primjene INCIVA, potrebno je razmotriti prekid i prestanak primjene ribavirina i/ili peginterferona alfa, istodobno ili jednog za drugim.
Administration of INCIVO may increase systemic exposure to medicinal products that are substrates of CYP3A or P-gp, which could increase or prolong their therapeutic effect and adverse reactions.
Primjena INCIVA može povisiti sistemsku izloženost lijekovima koji su supstrati CYP3A ili P-gp, što može povisiti ili produžiti njihov terapijski učinak i nuspojave.
Tell your doctor if you have heart failure, irregular heartbeat, slow heart rate, an abnormality shown in your heart tracing (ECG) called 'long QT syndrome', or a family history of a heart condition called 'congenital QT syndrome'.
Obavijestite svog liječnika ako imate zatajenje srca, nepravilne otkucaje srca, usporene otkucaje srca, poremećaj koji se vidi na elektrokardiogramu (EKG) a naziva se “sindrom produljenog QT intervala” ili ako Vam je netko u obitelji imao srčani poremećaj koji se naziva “kongenitalni sindrom produljenog QT intervala”.
Due to the combined treatment with peginterferon alfa and ribavirin, female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during INCIVO treatment.
Zbog kombiniranog liječenja s peginterferonom alfa i ribavirinom, bolesnice reproduktivne dobi i njihovi partneri, kao i muški bolesnici i njihove partnerice, moraju koristiti 2 učinkovite kontracepcijske metode za vrijeme liječenja INCIVOM.
If you need help, ask your doctor or pharmacist.
Ako Vam je potrebna pomoć, upitajte svog liječnika ili ljekarnika.
Efavirenz: with this combination the telaprevir dose must be increased to 1,125 mg three times per day (q8h).
Efavirenz: u ovoj kombinaciji doza telaprevira mora se povisiti na 1125 mg, tri puta na dan (svakih 8 sati).
All telaprevir-resistant variants studied remained fully sensitive to interferon-alfa, ribavirin, and representative HCV nucleoside and non-nucleoside polymerase inhibitors in the replicon system.
Sve ispitane varijante rezistentne na telaprevir ostale su potpuno osjetljive na interferon-alfa, ribavirin i nukleozidne i nenukleozidne reprezentativne inhibitore HCV polimeraze u replikonskom sustavu.
The lower limit of the 95% CI (-4.9%) was greater than the pre-determined noninferiority margin of -11% and therefore the non inferiority of T12(b.i.d.
Niža granica 95% CI (-4,9%) bila je veća od unaprijed određene margine neinferiornosti od -11% te je stoga pokazana neinferiornost T12(b.i.d.)/PR u usporedbi s T12(q8h)/PR.
Similar proportions of patients in both treatment groups had telaprevir-resistant variants at the time of failure.
Slični udjeli bolesnika u obje liječene skupine imale su, u vrijeme neuspjeha, varijante rezistentne na telaprevir.
Fifty-five out of 60 patients received ribavirin at a fixed dose of 800 mg/day and the remaining 5 patients received a weight-based ribavirin dose.
Pedeset i pet od 60 bolesnika primalo je ribavirin stalne doze od 800 mg/na dan, a preostalih 5 bolesnika primalo je dozu ribavirina ovisno o tjelesnoj težini.
ECG should be monitored at baseline and regularly during telaprevir treatment.
Potrebno je snimiti EKG na početku i redovito tijekom liječenja telaprevirom.
Since INCIVO must be used in combination with ribavirin and ribavirin can be very damaging to an unborn baby, both female and male patients must take special precautions in order to prevent pregnancy.
Obzirom da se INCIVO mora uzimati u kombinaciji s ribavirinom koji može biti vrlo štetan za nerođeno dijete, i žene i muškarci moraju poduzeti posebne mjere opreza za sprječavanje trudnoće.
The assay had a lower limit of quantification of 25 IU/ml.
Test je imao donju granicu kvantifikacije od samo 25 IU/ml.
There is limited pharmacokinetic data on the use of INCIVO in HCV patients aged ≥ 65 years and no data in subjects > 70 years of age.
Postoje samo ograničeni farmakokinetički podaci o primjeni INCIVA u bolesnika s HCV-infekcijom s ≥ 65 godina starosti, dok podaci za osobe s > 70 godina starosti ne postoje.
Maraviroc 150 mg twice daily when co-administered with telaprevir.
Kada se Maravirok 150 mg, dva puta na dan, primjenjuje istodobno s telaprevirom.
The median time for telaprevir-resistant variants to become undetectable by population sequencing was longer for variants NS3-36 (6 months), NS3-155 (9 months) and NS3-36M+NS3-155K (12 months) predominantly observed in patients with genotype 1a than for variants NS3-54 (2 months) and NS3-156 (3 months) predominantly observed in patients with genotype 1b.
Medijan vremena do nemjerljivosti varijanti rezistentnih na telaprevir prema populacijskoj analizi nukleotidnih sljedova genoma, bilo je dulje za varijante NS3-36 (6 mjeseci), NS3-155 (9 mjeseci) i NS3-36M+NS3-155K (12 mjeseci) pretežno opažene u bolesnika s genotipom 1a nego za varijante NS3-54 (2 mjeseca) i NS3-156 (3 mjeseca) pretežno opažene u bolesnika s genotipom 1b.
(< 25,000/mm absolute lymphocyte count
(< 25 000/mm apsolutni broj limfocita
Signs and symptoms of dehydration include increased thirst, dry mouth, decreased urine frequency or volume, and dark coloured urine.
Znakovi i simptomi dehidracije uključuju pojačanu žeđ, suha usta, smanjenu učestalost ili količinu mokrenja i mokraću tamne boje.
The highest documented INCIVO dose administered is 1,875 mg every 8 hours for 4 days in healthy volunteers.
Najviša primijenjena zabilježena doza INCIVA iznosi 1875 mg svakih 8 sati tijekom 4 dana u zdravih ispitanika.
No studies on the effects of INCIVO on the ability to drive and use machines have been performed.
Nisu provedena ispitivanja učinaka INCIVA na sposobnost upravljanja vozilima i rada sa strojevima.
Co-administration of sildenafil or tadalafil and telaprevir in the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Istodobna primjena sildenafila ili tadalafila i telaprevira u liječenju plućne arterijske hipertenzije je kontraindicirana (vidjeti dio 4.3).
Table 14: Pooled response rates: Study C208
Tablica 14: Objedinjene stope odgovora: Ispitivanje C208
If a patient achieved undetectable HCV RNA (target not detected) at week 4, the total treatment duration was 24 weeks.
Ako je bolesnik postigao nemjerljivu HCV RNK (cilj nije izmjeren) u 4. tjednu, ukupno trajanje liječenja bilo je 24 tjedna.
In general, exposure levels in relation to human values were low in animal pharmacology and toxicology studies.
Općenito, razine izloženosti u farmakološkim i toksikološkim ispitivanjima na životinjama bile su niže u odnosu na vrijednosti u ljudi.
Patients receiving cyclosporine A N = 24 % (n/N)
Bolesnici koji su primali ciklosporin A N = 24 % (n/N)
The denominator when calculating the relapse rate represents the number of patients with end-of-treatment response (HCV RNA < 25 IU/ml).
Nazivnik pri izračunu stope relapsa predstavlja broj bolesnika s odgovorom na kraju liječenja (HCV RNK < 25 IU/ml).
Increased clinical and laboratory monitoring are warranted (see section 4.4).
Nalaže se pojačan klinički i laboratorijski nadzor (vidjeti dio 4.4).
Refer to section 4.5 for established and other potentially significant drug-drug interactions.
Vidjeti dio 4.5 za ustanovljene i druge potencijalno značajne
Taking INCIVO without food or without regard to the dosing interval may result in decreased plasma concentrations of telaprevir which could reduce the
Uzimanje INCIVA bez hrane ili nepridržavanje preporučenog doziranja može dovesti do smanjene koncentracije telaprevira u plazmi te smanjenja terapijskog učinka INCIVA.
Such patients should be closely monitored, including ECG assessments.
Takve bolesnike treba pomno pratiti, uključujući EKG praćenje.
Sildenafil or tadalafil must not be used to treat a heart and lung disorder called pulmonary arterial hypertension.
Sildenafil ili tadalafil se ne smiju primjenjivati za liječenje poremećaja srca i pluća koji se zove plućna arterijska hipertenzija.
Patients were randomised in a 2:2:1 ratio to one of three treatment groups: simultaneous start (T12/PR48): INCIVO from day 1 through week 12; delayed start (T12(DS)/PR48): INCIVO from week 5 through week 16; Pbo/PR48: placebo through week 16.
Bolesnici su bili randomizirani u omjeru 2:2:1 u jednu od tri terapijske skupine: istodobni početak (T12/PR48): INCIVO od 1. dana do 12. tjedna; odgođeni početak (T12(DS)/PR48): INCIVO od 5. tjedna do 16. tjedna; Pbo/PR48: placebo do 16. tjedna.
To manage anaemia, at initiation of INCIVO treatment a lower starting dose of ribavirin (600 mg/day) was used; during the overall treatment phase the ribavirin dose was further reduced in 36.5% of patients, 41.9% received ESAs and 21.6% received blood transfusions (see sections 4.4 and 4.5, Immunosuppressants).
Zbog zbrinjavanja anemije, na početku liječenja INCIVOM koristila se niža početna doza ribavirina (600 mg/dan); tijekom ukupne faze liječenja doza ribavirina je dalje snižena u 36,5% bolesnika, 41,9% je primilo lijekove koji stimuliraju eritropoezu, a 21,6% je primilo transfuzije krvi (vidjeti djelove 4.4 i 4.5, Imunosupresivi).
After the end of INCIVO treatment, uric acid values typically decrease over the following 8 weeks and are comparable to those observed in patients receiving peginterferon alfa and ribavirin alone.
Nakon završetka liječenja INCIVOM, vrijednosti mokraćne kiseline obično se smanjuju tijekom sljedećih 8 tjedana i postaju usporedive s vrijednostima opaženima u bolesnika koji primaju samo peginterferon alfa i ribavirin.
Clinical and laboratory monitoring for hyperbilirubinaemia is recommended (see section 4.4 and 4.8).
Preporučuje se kliničko i laboratorijsko praćenje zbog hiperbilirubinemije (vidjeti dio 4.4 i 4.8).
When compared to administration following a standard normal caloric meal, exposure (AUC) decreased by 73% when telaprevir was taken on an empty stomach, by 26% following a low-calorie high-protein meal (9 g fat, 260 kcal), and by 39% following a low-calorie low-fat meal (3.6 g fat, 249 kcal).
Usporedba s primjenom nakon standardnog obroka normalne kalorijske vrijednosti pokazala je smanjenje izloženosti (AUC) za 73% kad se telaprevir uzimao na prazan želudac, za 26% kad se uzimao nakon niskokaloričnog obroka bogatog bjelančevinama (9 g masti, 260 kcal) te za 39% kad se uzimao nakon niskokaloričnog obroka s malim sadržajem masti (3,6 g masti, 249 kcal).
In the case of missing data within the week 72 window, the last HCV RNA data point from week 12 of follow-up onwards was used.
U slučaju da su podaci iz 72. tjedna nedostajali, koristili su se podaci zadnjeg prethodnog mjerenja HCV RNK 12. tjedna praćenja.
Population pharmacokinetic analysis of INCIVO in HCV-infected subjects indicated that the exposure to telaprevir was similar in Blacks/African-Americans and Caucasians.
Analiza populacijske farmakokinetike INCIVA u ispitanika s HCV infekcijom pokazala je da je izloženost telapreviru u ispitanika crne rase/afroamerikanaca bila slična onoj u ispitanika bijele rase.
Haemoglobin should be monitored at regular intervals prior to and during INCIVO combination treatment (see section 4.4, Laboratory tests).
Hemoglobin treba redovito pratiti prije i tijekom kombiniranog liječenja INCIVOM (vidjeti dio 4.4, Laboratorijski nalazi).
- painful inflammation of the joints most commonly in the foot (gout);
- bolna upala zglobova, najčešće zglobova stopala (giht);
Concomitant administration of INCIVO and drugs transported by these transporters such as fluvastatin, pravastatin, rosuvastatin, pitavastatin, bosentan and repaglinide should be undertaken with caution (see table 2).
Istodobna primjena lijeka INCIVO i lijekova koji su preneseni navedenim transporterima poput fluvastatina, pravastatina, rosuvastatina, pitavastatina, bosentana i repaglinida moraju se uzimati s oprezom (vidjeti Tablicu 2).
Concomitant administration with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Istodobna primjena s djelatnim tvarima čiji klirens uvelike ovisi o CYP3A i čije su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima.
HCV RNA levels should be monitored at weeks 4 and 12.
Razine HCV RNK treba pratiti u 4. i 12. tjednu.
All patients started with a dose of 600 mg/day of ribavirin and 180 µg/week of peginterferon alfa-2a.
Svi bolesnici započeli su s dozom od 600 mg/dan ribavirina i 180 µg/tjedan peginterferona alfa-2a.
INCIVO is not for use in children or adolescents, because it has not been sufficiently studied in
INCIVO nije namijenjen za primjenu u djece i adolescenata zbog toga što nije dovoljno ispitan u bolesnika mlađih od 18 godina,
Telaprevir is orally available, most likely absorbed in the small intestine, with no evidence for absorption in the colon.
Telaprevir postaje raspoloživ nakon peroralne primjene i najvjerojatnije se apsorbira u tankom crijevu, bez dokaza da se apsorbira u debelom crijevu.
It is not known whether telaprevir is dialyzable by peritoneal or haemodialysis.
Nije poznato može li se telaprevir ukloniti peritonejskom dijalizom ili hemodijalizom.
In HCV-negative patients with severe renal impairment, no clinically relevant change in telaprevir exposure was observed (see section 5.2).
U HCV negativnih bolesnika s teškim oštećenjem funkcije bubrega nisu primijećene klinički važne promjene izloženosti telapreviru (vidjeti dio 5.2).
Variants V36A/M, T54A/S, R155K/T, and A156S conferred lower levels of in vitro resistance to telaprevir (3- to 25-fold increase in telaprevir IC50), and the A156V/T and V36M+R155K variants conferred higher levels of in vitro resistance to telaprevir (> 25-fold increase in telaprevir IC50).
Varijante V36A/M, T54A/S, R155K/T i A156S pokazale su in vitro nižu razinu rezistencije na telaprevir (povećanje IC50 telaprevira za 3 do 25 puta), dok su varijante A156V/T i V36M+R155K in vitro pokazale više razine rezistencije na telaprevir (povećanje IC50 telaprevira za > 25 puta).
• Rash and Severe Cutaneous Adverse Reactions safety data from Phases 2 and 3
• Sigurnosne podatke o osipu i teškim kožnim nuspojavama iz faze II i III ispitivanja
All rashes should be monitored for progression and until the rash is resolved.
Sve vrste osipa treba pratiti zbog progresije i to do njegovog povlačenja.
(1.9-3.4 x ULN)
(1,9-3,4 x GGN)
Table 16: Treatment outcome in adult patients with genotype 1 HCV infection and HIV-1 co-infection in Study HPC3008)
Tablica 16: Ishod liječenja u odraslih bolesnika s HCV infekcijom gentipom 1 i istodobnom infekcijom HIVom-1 u Ispitivanju HPC3008)
If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage.
Ako je indicirano, uklanjanje neapsorbirane djelatne tvari može se postići povraćanjem ili lavažom želuca.
The primary assessment was an evaluation of non-inferiority, using a margin of -10.5% of the 24-week regimen compared to the 48-week regimen in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12.
Primarna procjena bila je ocjena neinferiornosti, uz marginu od -10,5% 24-tjednog režima u odnosu na 48-tjedni režim u bolesnika s nemjerljivim HCV RNK (cilj nije