natgillin/translations-raw huggingface dataset:
Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone with or without other drugs that lower heart rate.
Slučajevi teške bradikardije i srčanog bloka uočeni su kada se Harvoni koristi s amiodaronom i drugim lijekovima koji snižavaju srčanu frekvenciju ili bez njih.
The adverse reactions observed were consistent with those observed in clinical studies of ledipasvir/sofosbuvir in adults (see Table 6).
Opažene nuspojave bile su sukladne onima opaženima u kliničkim ispitivanjima ledipasvira/sofosbuvira u odraslih (vidjeti tablicu 6).
If you are not sure about taking any other medicines, talk to your doctor or pharmacist.
Ako niste sigurni u vezi s uzimanjem drugih lijekova, obratite se svom liječniku ili ljekarniku.
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 and GS-331007 is not an inhibitor of OAT1, OCT2 and MATE1.
Sofosbuvir i GS-331007 nisu inhibitori prijenosnika lijekova P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1, a GS-331007 nije inhibitor OAT1, OCT2 i MATE1.
Patients were randomised in a 1:1:1 ratio to one of the three treatment groups and stratified by HCV genotype (1a versus 1b).
Bolesnici su bili randomizirani u omjeru 1:1:1 u jednu od tri terapijske skupine i stratificirani prema genotipu HCV-a (1a naspram 1b).
What you need to know before you take Harvoni Do not take Harvoni
Što morate znati prije nego počnete uzimati Harvoni
HCV replicons with reduced susceptibility to ledipasvir have been selected in cell culture for genotype 1a and 1b.
Replikoni HCV-a sa smanjenom osjetljivošću na ledipasvir odabrani su u staničnoj kulturi za genotip 1a i 1b.
No human data on the effect of Harvoni on fertility are available.
Nema dostupnih podataka o utjecaju lijeka Harvoni na plodnost u ljudi.
Animal studies do not indicate direct harmful effects with respect to reproductive toxicity.
Ispitivanja na životinjama ne ukazuju na izravan štetan učinak na reprodukciju.
TOTAL (n = 865)
UKUPNO (n = 865)
Relative to fasting conditions, the administration of a single dose of ledipasvir/sofosbuvir with a moderate fat or high fat meal increased the sofosbuvir AUC0-inf by approximately 2-fold, but did not significantly affect the sofosbuvir Cmax.
U odnosu na stanje natašte, primjena jedne doze ledipasvira/sofosbuvira s umjereno masnim ili visoko-masnim obrokom povećala je AUC0-inf sofosbuvira za približno 2 puta, ali nije značajno utjecala na Cmax sofosbuvira.
Use with certain HIV antiretroviral regimens
Primjena s određenim antiretrovirusnim režimima liječenja HIV-a
Such co-administration is not recommended (see section 4.4).
Ne preporučuje se njihova istodobna primjena (vidjeti dio 4.4).
Animal studies do not indicate harmful effects of ledipasvir or sofosbuvir on fertility.
Ispitivanja na životinjama ne ukazuju na štetne učinke ledipasvira ili sofosbuvira na plodnost.
Table 18: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection
Tablica 18: Stope odgovora (SVR12) na ledipasvir/sofosbuvir tijekom 12 tjedana u bolesnika s infekcijom genotipom 2, 4, 5 i 6 HCV-a
Cirrhosis was defined by biopsy, Fibroscan (> 12.5 kPa) or FibroTest > 0.75 and an AST:platelet ratio index (APRI) of > 2.
Ciroza je bila definirana na temelju biopsije, Fibroscana (> 12,5 kPa) ili FibroTesta > 0,75 i indeksa omjera AST-a i trombocita (APRI) > 2.
Table 3: Guidance for ribavirin dosing when administered with Harvoni to adolescents aged 12 to < 18 years.
Tablica 3: Smjernice za doziranje ribavirina kada se primjenjuje s lijekom Harvoni, kod adolescenata u dobi od 12 do < 18 godina
c Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
c. Ostalo uključuje bolesnike koji nisu postigli SVR i nisu zadovoljili kriterije virološkog neuspjeha (npr. izgubljeni iz praćenja).
Lopinavir boosted with ritonavir + emtricitabine/ tenofovir disoproxil fumarate
Lopinavir pojačan ritonavirom + emtricitabin/ tenofovirdizoproksilfumarat
• You or your partner must use an effective birth control method during treatment with Harvoni together with ribavirin and for some time afterwards.
• Vi ili Vaš(a) partner(ica) morate primjenjivati učinkovitu metodu kontrole začeća tijekom i neko vrijeme nakon liječenja lijekom Harvoni zajedno s ribavirinom.
Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively due to the parent drug (> 98%).
Nakon jedne doze od 90 mg [14C]-ledipasvira, sistemska izloženost bila je gotovo isključivo posljedica izloženosti ishodišnom lijeku (> 98 %).
Relapsea
Relapsa
Co-administration of Harvoni with digoxin may increase the concentration of digoxin.
Istovremena primjena lijeka Harvoni s digoksinom može povećati koncentraciju digoksina.
In genotype 3 infected patients experiencing virologic failure, development of NS5A RAVs (including enrichment of RAVs present at baseline) was typically not detected at the time of failure (n = 17).
U bolesnika zaraženih genotipom 3 u kojih je došlo do virološkog neuspjeha, razvoj NS5A RAV-ova (uključujući obogaćenje RAV-ova prisutno na početku) obično nije bio otkriven u vrijeme virološkog neuspjeha (n =17).
Ledipasvir activity (EC50, nM)
Djelovanje ledipasvira (EC50, nM)
NS5B transient replicons Median (range)a
NS5B prolazni replikoni Medijan (raspon)a
Ledipasvir, sofosbuvir, and GS-331007 exposures in adolescents aged 12 to < 18 years were similar to those in adults from Phase 2/3 studies, following administration of ledipasvir/sofosbuvir (90 mg/400 mg).
Izloženost ledipasviru, sofosbuviru i GS-331007 u adolescenata u dobi od 12 do < 18 godina bila je slična onoj u odraslih u ispitivanjima faze 2/3 nakon primjene ledipasvira/sofosbuvira (90 mg/400 mg).
The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT class B and C).
Farmakokinetika sofosbuvira bila je ispitana nakon 7 dana doziranja 400 mg sofosbuvira u bolesnika zaraženih HCV-om s umjerenim i teškim oštećenjem jetre (CPT stadij B i C).
Table 17: Combined response rates (SVR12) in studies SOLAR-1 and SOLAR-2 LDV/SOF+RBV 12 weeks (n = 307)a,b
Tablica 17: Kombinirane stope odgovora (SVR12) u ispitivanjima SOLAR-1 i SOLAR-2 LDV/SOF+RBV 12 tjedana (n = 307)a,b
Use with strong P-gp inducers
Primjena s jakim induktorima P-gp-a
IL28CC genotype
IL28CC genotip
Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow FCF aluminium lake (E110)
Film ovojnica: poli(vinilni alkohol), titanijev dioksid, makrogol 3350, talk, boja sunset yellow FCF aluminium lake (E110).
Ribavirin Dose* 15 mg/kg/day 600 mg/day 800 mg/day 1000 mg/day
Doza ribavirina* 15 mg/kg na dan 600 mg na dan 800 mg na dan 1000 mg na dan
• Tell your doctor or pharmacist if you are taking any of the medicines below:
Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova:
• Do not take any other medicine that contains sofosbuvir, one of the active substances in
• Nemojte uzimati nijedan drugi lijek koji sadrži sofosbuvir, što je jedna od djelatnih tvari u lijeku Harvoni.
There are presently no data to support the effectiveness of retreatment of patients who have failed ledipasvir/sofosbuvir with a subsequent regimen that contains an NS5A inhibitor.
Trenutno nema podataka koji podupiru učinkovitost ponovnog liječenja bolesnika u kojih su ledipasvir/sofosbuvir bili neuspješni pomoću režima koji sadrži inhibitor NS5A.
• outer cartons containing 1 bottle of 28 film-coated tablets
• kutije koje sadrže 1 bocu s 28 filmom obloženih tableta
Adults with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant
Odrasli s dekompenziranom cirozom i/ili koji čekaju transplantaciju jetre ili poslije transplantacije jetre
Mean ratio (90% confidence interval) for
Srednja vrijednost omjera (90 % interval pouzdanosti) za AUC,
Warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Varfarin i drugi slični lijekovi pod nazivom antagonisti vitamina
Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%.
Hemodijalizom se može učinkovito odstraniti glavni cirkulirajući metabolit sofosbuvira, GS-331007, uz omjer ekstrakcije od 53 %.
Following oral administration of ledipasvir/sofosbuvir to HCV-infected patients, ledipasvir median peak plasma concentration was observed at 4.0 hours post-dose.
Nakon peroralne primjene ledipasvira/sofosbuvira u bolesnika zaraženih HCV-om, medijan vršnih koncentracija ledipasvira u plazmi bio je opažen 4,0 sata nakon uzimanja doze.
b Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
b. Ostalo uključuje bolesnike koji nisu postigli SVR i nisu zadovoljili kriterije virološkog neuspjeha (npr. izgubljeni iz praćenja).
If ribavirin is co-administered with Harvoni, the contraindications regarding use of ribavirin during pregnancy and breast-feeding apply (see also the Summary of Product Characteristics for ribavirin).
Ako se ribavirin primjenjuje istovremeno s lijekom Harvoni, vrijede kontraindikacije za primjenu ribavirina tijekom trudnoće i dojenja (vidjeti također sažetak opisa svojstava lijeka za ribavirin).
a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Srednja vrijednost omjera (90 % CI) farmakokinetike lijekova istovremeno primijenjenih s jednim ispitivanim lijekom ili u kombinaciji s oba ispitivana lijeka.
In phenotypic analyses, post-baseline isolates from patients who harboured NS5A RAVs at failure showed 20- to at least a 243-fold (the highest dose tested) reduced susceptibility to ledipasvir.
U fenotipskim analizama, izolati nakon početka ispitivanja kod bolesnika koji su nosili NS5A RAV u vrijeme virološkog neuspjeha pokazali su 20 do najmanje 243 puta (najviša ispitana doza) smanjenu osjetljivost na ledipasvir.
b Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4.
b. Rezultati FibroTesta koji nisu nedostajali bili su mapirani na Metavir-rezultate prema sljedećem: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,59-1,00 = F3-F4.
NS5A transient replicons Median (range)a
NS5A prolazni replikoni Medijan (raspon)a
Medicinal products that are strong P-gp inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
Lijekovi koji su jaki induktori P-gp (karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin i gospina trava) mogu značajno smanjiti koncentracije ledipasvira i sofosbuvira u plazmi i tako dovesti do smanjenog terapijskog učinka ledipasvira/sofosbuvira te su stoga kontraindicirani s lijekom Harvoni (vidjeti dio 4.3).
Proton pump inhibitors should not be taken before Harvoni.
Inhibitori protonske pumpe ne smiju se uzeti prije lijeka Harvoni.
It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk.
Nije poznato izlučuju li se ledipasvir ili sofosbuvir i njihovi metaboliti u majčino mlijeko.
Table 19: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Tablica 19: Stope odgovora (SVR12) u bolesnika s infekcijom genotipom 3 (ELECTRON-2) LDV/SOF+RBV 12 tjedana
Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
AUC0-24 i Cmax sofosbuvira i GS-331007 bile su slične u zdravih odraslih ispitanika i bolesnika s HCV-infekcijom.
Similarly, there are presently no data to support the effectiveness of NS3/4A protease inhibitors in patients who previously failed prior therapy that included an NS3/4A protease inhibitor.
Slično tome, trenutno nema podataka koji podupiru učinkovitost inhibitora proteaze NS3/4A u bolesnika u kojih je prethodna terapija koja je uključivala inhibitor proteaze NS3/4A bila neuspješna.
Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Ledipasvir je inhibitor HCV-a usmjeren na protein HCV NS5A, koji je neophodan kako za replikaciju RNK, tako i za sklapanje viriona HCV-a.
This may make Harvoni work less well.
To može oslabiti djelovanje lijeka Harvoni.
• dabigatran used to thin the blood;
• dabigatran koji se primjenjuje za razrjeđivanje krvi;
The safety profile of ledipasvir/sofosbuvir with ribavirin for 12 or 24 weeks in adults with decompensated liver disease and/or those post-liver transplant was assessed in two open-label studies (SOLAR-1 and SOLAR-2).
Sigurnosni profil ledipasvira/sofosbuvira s ribavirinom tijekom 12 ili 24 tjedna u odraslih s dekompenziranom bolešću jetre i/ili onih poslije transplantacije jetre bio je procijenjen u dva otvorena ispitivanja (SOLAR-1 i SOLAR-2).
Sofosbuvir and GS-331007 are not inhibitors or inducers of CYP or uridine diphosphate glucuronosyltransferase (UGT) 1A1 enzymes.
Sofosbuvir i GS-331007 nisu ni inhibitori niti induktori enzima CYP ili uridin difosfat glukuronoziltransferaze (UGT) 1A1.
Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
U odnosu na one u zdravih ispitanika (n = 191), AUC0-24 i Cmax ledipasvira u bolesnika zaraženih HCV-om iznosile su 24 % manje odnosno 32 % manje.
The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV virus.
Na farmakokinetiku lijekova koji se metaboliziraju putem jetre (npr. imunosupresivi, kao što su inhibitori kalcineurina) mogu utjecati promjene u funkciji jetre tijekom terapije direktno djelujućim antiviroticima, a koje su povezane s klirensom HCV-a.
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Sofosbuvir je nukleotidni predlijek iz kojeg unutarstaničnim metabolizmom nastaje farmakološki djelatan uridinu analogni trifosfat (GS-461203), koji se može ugraditi u RNK HCV-a pomoću NS5B polimeraze i djelovati kao terminator lanca.
Patients were stratified by HCV genotype (1a versus 1b) and prior treatment response (whether HCV RNA < LLOQ had been achieved).
Bolesnici su bili stratificirani prema genotipu HCV-a (1a naspram 1b) i prethodnom terapijskom odgovoru (je li bio postignut HCV RNK < LLOQ).
TOTAL (n = 440)
UKUPNO (n = 440)
The efficacy of ledipasvir/sofosbuvir in genotype 5 and genotype 6 HCV-infected patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant has not been investigated.
Djelotvornost ledipasvira/sofosbuvira u bolesnika zaraženih HCV-om genotipa 5 i genotipa 6 s dekompenziranom cirozom i/ili onih koji čekaju transplantaciju jetre ili poslije transplantacije jetre nije ispitana.
In the SIRIUS study (see “Clinical efficacy and safety”, below) 5 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with or without ribavirin.
U ispitivanju SIRIUS (vidjeti niže „Klinička djelotvornost i sigurnost“), 5 bolesnika zaraženih genotipom 1 imalo je relaps nakon liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega.
264b a. Transient replicons carrying NS5A or NS5B from patient isolates.
Prolazni replikoni koji nose NS5A ili NS5B iz izolata bolesnika.
Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Harvoni.
Potreban je oprez i preporučuje se nadzor terapijskih koncentracija digoksina kad se primjenjuje istovremeno s lijekom Harvoni.
Sofosbuvir had no effects on embryo-foetal viability or on fertility in rat and was not teratogenic in rat and rabbit development studies.
Sofosbuvir nije imao učinaka na embriofetalnu održivost ili na plodnost u štakora i nije bio teratogen u ispitivanjima razvojne toksičnosti u štakora i kunića.
Do not take it before Harvoni.
Nemojte ga uzeti prije lijeka Harvoni.
Patients who are post-liver transplant without cirrhosis or with compensated cirrhosis
Bolesnici poslije transplantacije jetre bez ciroze ili s kompenziranom cirozom
The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 7.
Vrijednosti EC50 ledipasvira i sofosbuvira protiv replikona pune duljine ili kimeričkih replikona koji kodiraju sekvence NS5A i NS5B iz kliničkih izolata navedene su u tablici 7.
All patients in the study were treated with ledipasvir/sofosbuvir for 12 weeks.
Svi bolesnici u ispitivanju liječeni su ledipasvirom/sofosbuvirom 12 tjedana.
Neither ledipasvir nor sofosbuvir are substrates for hepatic uptake transporters, organic cation transporter (OCT) 1, organic anion-transporting polypeptide (OATP) 1B1 or OATP1B3.
Ni ledipasvir niti sofosbuvir nisu supstrati prijenosnika za unos u jetru, prijenosnika organskih kationa (OCT)1, polipeptida za prijenos organskih aniona (OATP) 1B1 ili OATP1B3.
Gilead Sciences Ireland UC Тел.
Gilead Sciences Ireland UC.
Treatment-naïve adults without cirrhosis - ION-3 (study 0108) - Genotype 1
Odrasli bez ciroze koji prethodno nisu bili liječeni - ION-3 (ispitivanje 0108) - genotip 1
TOTAL (n = 647)
UKUPNO (n = 647)
HCV/HIV co-infected adults - ION-4
Odrasli istovremeno zaraženi HCV/HIV-om - ION-4
Harvoni treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Liječenje lijekom Harvoni treba započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s CHC-om.
Randomisation was stratified by the presence or absence of cirrhosis and HCV genotype (1a versus 1b).
Randomizacija je bila stratificirana prema prisutnosti ili odsutnosti ciroze i genotipu HCV-a (1a naspram 1b).
If a dose is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Ako se propusti uzeti dozu, a još nije proteklo 18 sati od uobičajenog vremena uzimanja, bolesnicima treba savjetovati da uzmu tabletu čim prije i zatim uzmu sljedeću dozu u uobičajeno vrijeme.
However, the NS5B S282T substitution in combination with NS5A substitutions L31M, Y93H and Q30L were detected in one patient at failure following 8 weeks of treatment with ledipasvir/sofosbuvir from a Phase 2 study (LONESTAR).
Međutim, bila je otkrivena supstitucija NS5B S282T u kombinaciji s NS5A supstitucijama L31M, Y93H i Q30L u jednog bolesnika u vrijeme virološkog neuspjeha nakon 8 tjedana liječenja ledipasvirom/sofosbuvirom u jednom ispitivanju faze 2 (LONESTAR).
• tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate,
• tenofovirdizoproksilfumarat ili bilo koji lijek koji sadrži tenofovirdizoproksilfumarat, koji se primjenjuje za liječenje HIV-infekcije;
b. The chimeric replicons carrying NS5A genes from genotype 2b, 5a, 6a and 6e were used for testing ledipasvir while the chimeric replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing sofosbuvir.
b. Za ispitivanje ledipasvira bili su uporabljeni kimerički replikoni koji nose NS5A gene iz genotipova 2b, 5a, 6a i 6e, dok su za ispitivanje sofosbuvira bili uporabljeni kimerički replikoni koji nose NS5B gene iz genotipova 2b, 5a ili 6a.
Harvoni can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Harvoni se u tih bolesnika može primjenjivati bez prilagodbe doze kada nisu dostupne nikakve druge odgovarajuće mogućnosti liječenja (vidjeti dijelove 4.8, 5.1 i 5.2).
However, patients should be advised that fatigue was more common in patients treated with ledipasvir/sofosbuvir compared to placebo.
Međutim, bolesnike treba upozoriti da je umor bio češći u bolesnika liječenih ledipasvirom/sofosbuvirom nego placebom.
Co-administration of Harvoni and HMG-CoA reductase inhibitors (statins) can significantly increase the concentration of the statin, which increases the risk of myopathy and rhabdomyolysis (see section 4.5).
Istovremena primjena lijeka Harvoni i inhibitora HMG-CoA reduktaze (statina) može značajno povećati koncentraciju statina, što povećava rizik od miopatije i rabdomiolize (vidjeti dio 4.5).
A NS5B substitution E237G was detected in 3 patients (1 genotype 1b and 2 genotype 1a) in the Phase 3 studies (ION-3, ION-1 and ION-2) and 3 patients with genotype 1a infection in the SOLAR-1 and SOLAR-2 studies at the time of relapse.
NS5B supstitucija E237G otkrivena je u 3 bolesnika (1 s genotipom 1b i 2 s genotipom 1a) u ispitivanjima faze 3 (ION-3, ION-1 i ION-2) i 3 bolesnika s infekcijom genotipom 1a u ispitivanjima SOLAR-1 i SOLAR-2 u vrijeme relapsa.
For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 18).
Za infekciju genotipom 2, 4, 5 i 6, terapija se sastojala od ledipasvira/sofosbuvira bez ribavirina, koja se davala 12 tjedana (tablica 18).
When co-administered with Harvoni, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 4.4).
Kad se primjenjuju istovremeno s lijekom Harvoni, potrebno je razmotriti sniženu dozu statina i provoditi pažljivo praćenje zbog nuspojava statina (vidjeti dio 4.4).
Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Pokazalo se da Harvoni povećava izloženost tenofoviru, osobito kad se primjenjuje zajedno s režimom liječenja HIV-a koji sadrži tenofovirdizoproksilfumarat i farmakokinetički pojačivač (ritonavir ili kobicistat).
The SVR rates for the 8, 12, and 24 week ledipasvir/sofosbuvir treatment groups were 93% (42/45), 100% (31/31), and 79% (15/19), respectively.
Stope SVR-a u skupinama liječenima ledipasvirom/sofosbuvirom tijekom 8, 12 odnosno 24 tjedna bile su 93 % (42/45), 100 % (31/31) odnosno 79 % (15/19).
Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to ledipasvir.
Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om pokazala je da ciroza (uključujući dekompenziranu cirozu) nije imala klinički važan utjecaj na izloženost ledipasviru.
Do not take proton pump inhibitors before Harvoni.
Nemojte uzimati inhibitore protonske pumpe prije lijeka Harvoni.
Of the remaining 154 patients, a total of 149 achieved SVR12 across both treatment groups; 96% (74/77) of patients in the ledipasvir/sofosbuvir with ribavirin 12-week group and 97% (75/77) of patients in the ledipasvir/sofosbuvir 24-week group.
Od preostala 154 bolesnika, njih ukupno 149 iz obje terapijske skupine postiglo je SVR12; 96 % (74/77) bolesnika u skupini liječenoj ledipasvirom/sofosbuvirom s ribavirinom tijekom 12 tjedana i 97 % (75/77) bolesnika u skupini liječenoj ledipasvirom/sofosbuvirom tijekom 24 tjedna.
It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk.
Nije poznato prelaze li ledipasvir ili sofosbuvir, dvije djelatne tvari u lijeku Harvoni, u majčino mlijeko kod ljudi.
The clinical data to support the use of Harvoni in adults infected with HCV genotype 2 and 6 are limited (see section 5.1).
Klinički podaci koji podupiru primjenu lijeka Harvoni u odraslih zaraženih HCV-om genotipa 2 i 6 su ograničeni (vidjeti dio 5.1).
Adult and adolescent patients 12 years of age or older with genotype 3 CHC
Odrasli i adolescenti u dobi od 12 ili više godina s CHC-om uzrokovanim genotipom 3