natgillin/translations-raw huggingface dataset:
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Harvoni.
Zaradi dolge razpolovne dobe amiodarona je treba ustrezno spremljati tudi bolnike, ki so prekinili zdravljenje z amiodaronom v zadnjih nekaj mesecih in bodo začeli zdravljenje z zdravilom Harvoni.
If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Harvoni.
Če jemljete antacid, ga vzemite vsaj 4 ure pred zdravilom Harvoni ali najmanj 4 ure po tem.
Posology The recommended dose of Harvoni is one tablet once daily with or without food (see section 5.2).
Priporočeni odmerek zdravila Harvoni je ena tableta enkrat na dan s hrano ali brez nje (glejte poglavje 5.2).
Of the seven patients who did not achieve SVR12, none experienced virologic failure or relapsed.
Med sedmimi bolniki, ki niso dosegli SVR12, ni nobeden doživel virološkega neuspeha ali relapsa.
Body weight did not have a significant effect on sofosbuvir exposure according to a population pharmacokinetic analysis.
Telesna masa ni pomembno vplivala na izpostavljenost sofosbuvirju glede na analizo populacijske farmakokinetike.
The adverse reactions are listed below by body system organ class and frequency.
Neželeni učinki so spodaj navedeni po organskih sistemih in pogostnosti.
Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded as recommended in the Summary of Product Characteristics for ribavirin.
Ženske v rodni dobi ali njihovi moški partnerji morajo med zdravljenjem in še v obdobju po zaključku zdravljenja uporabljati učinkovito obliko kontracepcije, kot je priporočeno v povzetku glavnih značilnosti za zdravilo za ribavirin.
Concerning recommended regimens with different HCV genotypes, see section 4.2.
Za priporočene režime z različnimi genotipi HCV glejte poglavje 4.2.
Haemodialysis is unlikely to result in significant removal of ledipasvir as ledipasvir is highly bound to plasma protein.
Ni verjetno, da bi hemodializa pomembno odstranila ledipasvir, saj se ledipasvir v visoki meri veže na beljakovine v plazmi.
Table 1: Recommended treatment duration for Harvoni and the recommended use of co-administered ribavirin for certain subgroups
Preglednica 1: Priporočeno trajanje zdravljenja za zdravilo Harvoni in priporočena uporaba sočasno dajanega ribavirina za nekatere podskupine
Non-CC
Ne-CC
Swallow the tablet whole with or without food.
Tableto pogoltnite celo s hrano ali brez nje.
Your doctor will know if any of the following conditions apply to you.
Opozorila in previdnostni ukrepi Zdravnik bo vedel, če se katero koli od naslednjih stanj nanaša na vas.
Patients were enrolled in one of the seven groups based on liver transplantation status and severity of hepatic impairment (see Table 17).
Bolniki so bili vključeni v sedem skupin glede na status presaditve jeter in resnost jetrne okvare (glejte preglednico 17).
a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
a. Povprečno razmerje (90-odstotni IZ) farmakokinetike s sočasno uporabljenimi študijskimi zdravili posamezno ali v kombinaciji.
As liver function may change during treatment with Harvoni, a close monitoring of International Normalised Ratio (INR) values is recommended.
Ker se delovanje jeter v času zdravljenja z zdravilom Harvoni lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
Due to the limited size of studies, the impact of baseline NS5A RAVs on treatment outcome for patients with genotype 2, 3, 4, 5 or 6 CHC has not been fully evaluated.
Zaradi omejene velikosti študij učinka izhodiščnih RAV NS5A na izid zdravljenja za bolnike s CHC genotipa 2, 3, 4, 5 ali 6 niso povsem ovrednotili.
d 3/3 of these patients had cirrhosis.
d. 3 od teh 3 bolnikov so imeli cirozo.
Harvoni treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Zdravljenje z zdravilom Harvoni mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov s CHC.
HBV screening should be performed in all patients before initiation of treatment.
Pri vseh bolnikih je treba pred začetkom zdravljenja izvesti presejanje za HBV.
IMMUNOSUPPRESSANTS Ciclosporing
IMUNOSUPRESIVI Ciklosporing
The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.
Test je imel spodnjo mejo kvantifikacije (LLOQ-lower limit of quantification) 25 i.e./ml.
Haemoglobin in patients with no cardiac disease
Hemoglobin pri bolnikih brez bolezni srca
• statins used to treat high cholesterol;
• statini, ki se uporabljajo za zdravljenje visoke ravni holesterola,
Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.).
Delovanje jeter se lahko zaradi zdravljenja hepatitisa C spremeni, kar lahko vpliva na druga zdravila (npr. zdravila, ki se uporabljajo za zaviranje imunskega sistema, itd.).
Baseline NS5A RAVs were overrepresented in patients who experienced relapse in the Phase 3 studies (see “Clinical efficacy and safety”).
Izhodiščne RAV NS5A so bile prekomerno zastopane pri bolnikih, ki so v študijah 3. faze doživeli relaps (glejte »Klinična učinkovitost in varnost«).
Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed (see section 5.2).
Zaradi grenkega okusa je priporočljivo, da se filmsko obložene tablete ne žveči in ne drobi (glejte poglavje 5.2).
In vitro, no detectable metabolism of ledipasvir was observed by human CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
In vitro niso opazili zaznavne presnove ledipasvirja s pomočjo človeških encimov CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4.
Taking Harvoni with any of these may stop your medicines from working properly, or make any side effects worse.
Jemanje zdravila Harvoni s katerim koli od teh zdravil lahko povzroči, da vaša zdravila morda ne bodo pravilno delovala ali pa se bodo neželeni učinki okrepili.
If the starting dose is not well tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels
Če bolnik začetnega odmerka ne prenaša dobro, je treba odmerek zmanjšati, kot je klinično indicirano na podlagi vrednosti hemoglobina.
Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Harvoni.
Zdravnik bo morda moral skrbno spremljati ta zdravila, ki jih jemljete, in po uvedbi zdravila Harvoni izvesti prilagoditve.
All three Phase 3 studies evaluated the efficacy of ledipasvir/sofosbuvir with or without ribavirin.
V vseh treh študijah 3. faze so ocenjevali učinkovitost ledipasvirja/sofosbuvirja z ribavirinom ali brez njega.
Ledipasvir activity (EC50, nM)
Aktivnost ledipasvirja (EC50, nM)
What Harvoni is and what it is used for
Kaj je zdravilo Harvoni in za kaj ga uporabljamo
The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of ledipasvir by 12-fold against genotype 1a HCV replicons.
Prisotnost 40 % humanega seruma ni vplivala na aktivnost sofosbuvirja proti HCV, je pa aktivnost ledipasvirja proti HCV zmanjšala za 12-krat proti replikonom HCV genotipa 1a.
Adults-Genotype 2, 3, 4, 5 and 6
Odrasli, genotip 2, 3, 4, 5 in 6
↔ indicates no clinically relevant change in the exposure of Ledipasvir.
↔ pomeni, da ni klinično pomembne spremembe izpostavljenosti ledipasvirju.
Although adverse events, including serious adverse events, occurred more frequently in this study compared to studies that excluded decompensated patients and/or patients who were postliver transplantation, the adverse events observed were those expected as clinical sequelae of advanced liver disease and/or transplantation or were consistent with the known safety profile of ribavirin (see section 5.1 for details of this study).
Čeprav so se neželeni učinki, vključno z resnimi neželenimi učinki, v teh študijah pojavili pogosteje kot v študijah, ki so izključile dekompenzirane bolnike in/ali bolnike po presaditvi jeter, so bili opaženi učinki pričakovani kot klinična posledica napredovale bolezni jeter in/ali presaditve ali pa so bili skladni z znanim profilom varnosti zdravljenja z ribavirinom (za podrobnosti te študije glejte poglavje 5.1).
• you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine).
• jemljete ali ste v zadnjih nekaj mesecih jemali zdravilo amiodaron za zdravljenje nerednega srčnega utripa (če jemljete ali ste jemali to zdravilo, bo zdravnik morda razmislil o drugih možnostih zdravljenja).
Harvoni (without ribavirin) for 24 weeks.
Zdravilo Harvoni (brez ribavirina) 24 tednov.
This data indicate that renal clearance is the major elimination pathway for GS-331007 with a large part actively secreted.
Ta podatek kaže, da je ledvični očistek glavna pot izločanja za GS-331007, pri čemer se velik del aktivno izloči.
Interactions cannot be excluded with other HMG-CoA reductase inhibitors.
Interakcij z drugimi zaviralci reduktaze HMG-CoA ni mogoče izključiti.
HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Pri bolnikih s sočasno okužbo s HBV/HCV obstaja tveganje za reaktivacijo HBV, zato jih je treba spremljati in zdraviti po trenutno veljavnih kliničnih smernicah.
Table 4 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and cardiac status.
V preglednici 4 so navedene smernice za prilagajanje in ukinitev odmerka na podlagi bolnikovih koncentracij hemoglobina in srčnega statusa.
Site-directed mutagenesis of the S282T substitution in replicons of 8 genotypes conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the viral replication capacity by 89% to 99% compared to the corresponding wild-type.
Usmerjena mutageneza substitucije S282T v replikonih 8 genotipov je doprinesla k 2- do 18-krat zmanjšani dovzetnosti za sofosbuvir in zmanjšala replikacijsko sposobnost virusa za 89 % do 99 % v primerjavi z ustreznim nemutiranim tipom virusa.
• If you or your partner become pregnant during Harvoni and ribavirin treatment or in the months that follow, you must contact your doctor immediately.
• Če vi ali vaša partnerka med zdravljenjem z zdravilom Harvoni in ribavirinom ali v mesecu, ki mu sledi, zanosite, morate o tem takoj obvestiti zdravnika.
In adolescent patients aged 12 to < 18 years the following ribavirin dosing is recommended where ribavirin is divided into two daily doses and given with food:
Pri mladostnikih, starih od 12 do < 18 let, se priporoča naslednje odmerjanje ribavirina, pri čemer se ribavirin razdeli v dva dnevna odmerka in daje s hrano:
NS5A substitutions conferring resistance to ledipasvir may reduce the antiviral activity of other NS5A inhibitors.
Substitucije NS5A, ki bi doprinesle k odpornosti na ledipasvir, lahko zmanjšajo protivirusno aktivnost drugih zaviralcev NS5A.
The medicinal product interactions described are based on studies conducted with either ledipasvir/sofosbuvir or ledipasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with ledipasvir/sofosbuvir.
Opisane interakcije med zdravili temeljijo na študijah, izvedenih z bodisi ledipasvirjem/sofosbuvirjem ali ledipasvirjem in sofosbuvirjem kot posameznimi učinkovinami ali so predvidene interakcije med zdravili, ki se lahko pojavijo z ledipasvirjem/sofosbuvirjem.
264b a. Transient replicons carrying NS5A or NS5B from patient isolates.
264b a. Prehodni replikoni ki nosijo NS5A ali NS5B, iz izolatov bolnikov,
Adolescents: for ribavirin dosing recommendations see table 3 below.
Mladostniki: za priporočila za odmerjanje ribavirina glejte preglednico 3 spodaj.
Each film-coated tablet contains 156.8 mg of lactose (as monohydrate) and 261 micrograms of sunset yellow FCF aluminium lake.
Ena filmsko obložena tableta vsebuje 156,8 mg laktoze (v obliki monohidrata) in 261 mikrogramov barvila sončno rumeno FCF.
Serum HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Vrednosti RNA HCV v serumu so izmerili med kliničnimi študijami s testom COBAS TaqMan za virus HCV (različica 2.0), za uporabo s sistemom High Pure System.
Baseline HCV RNAa HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
HCV RNA < 6 milijonov i.e./ml HCV RNA ≥ 6 milijonov i.e./ml
It is given to treat chronic (long-term) hepatitis C virus infection in adults and adolescents 12 to less than 18 years of age.
Daje se za kronično (dolgotrajno) zdravljenje okužbe z virusom hepatitisa C pri odraslih in mladostnikih, starih od 12 do < 18 let.
The safety of Harvoni has been evaluated in a 12-week non-controlled study including 95 patients with ESRD requiring dialysis (Study 4063).
Varnost zdravila Harvoni so ovrednotili v 12-tedenski nenadzorovani študiji, v katero je bilo vključenih 95 bolnikov z ESRD, ki so potrebovali dializo (študija 4063).
The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1,200 mg, respectively.
Najvišja dokumentirana odmerka ledipasvirja in sofosbuvirja sta bila 120 mg dvakrat na dan 10 dni oz. enkratni odmerek 1.200 mg.
The relative efficacy of a 12-week regimen consisting of ledipasvir/sofosbuvir + ribavirin, compared to a 24-week regimen of sofosbuvir + ribavirin has not been investigated.
Relativna učinkovitost 12-tedenskega režima ledipasvirja/sofosbuvirja + ribavirina v primerjavi s 24-tedenskim režimom sofosbuvirja + ribavirina ni bila preučena.
Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome.
Opravili so analize, s katerimi so preučili povezavo obstoječih izhodiščnih RAV NS5A in izidom zdravljenja.
Ledipasvir plasma exposure (AUCinf) was similar in patients with severe hepatic impairment and control patients with normal hepatic function.
Izpostavljenost ledipasvirja v plazmi (AUCinf) je bila pri bolnikih s hudo jetrno okvaro podobna kot pri kontrolnih bolnikih z normalnim delovanjem jeter.
HCV replicons with reduced susceptibility to sofosbuvir have been selected in cell culture for multiple genotypes including 1b, 2a, 2b, 3a, 4a, 5a and 6a.
Replikoni HCV z zmanjšano dovzetnostjo za sofosbuvir so bili izbrani v celični kulturi za več genotipov, vključno z 1b, 2a, 2b, 3a, 4a, 5a in 6a.
Carcinogenicity studies in mice and rats do not indicate any carcinogenicity potential of sofosbuvir administered at doses up to 600 mg/kg/day in mouse and 750 mg/kg/day in rat.
Študije kancerogenosti pri miših in podganah niso pokazale kancerogenega potenciala sofosbuvirja ki so ga miši dobivale v odmerkih do 600 mg/kg/dan in podgane 750 mg/kg/dan.
b Two patients who did not have decompensated cirrhosis and had also not received a liver transplant were excluded due to failure to meet the inclusion criteria for any of the treatment groups.
b. Dva bolnika, ki nista imela dekompenzirane ciroze in ki nista opravila presaditve, sta bila izključena, ker nista ustrezala kriterijem za vključitev v nobeno od skupin zdravljenja.
Medicinal product by therapeutic areas
Zdravila po terapevtskih področjih
All 5 patients who did not achieve SVR12 relapsed after having end-of-treatment response (see section “Resistance” - “In clinical studies” above).
Pri vseh 5 bolnikih, ki niso dosegli SVR12, je prišlo po odzivu ob koncu zdravljenja do relapsa (glejte zgornje poglavje »Odpornost« - »V kliničnih študijah«).
Harvoni + ribavirinA for 12 weeks or
Zdravilo Harvoni + ribavirinA 12 tednov ali
When administered to lactating rats, ledipasvir was detected in plasma of suckling rats likely due to excretion of ledipasvir via milk.
Pri dajanju podganam v laktaciji, so ledipasvir odkrili v plazmi dojenih podgan, verjetno kot posledico izločanja ledipasvirja v mleko.
Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet.
Zdravilo Harvoni je zdravilo, ki vsebuje učinkovini ledipasvir in sofosbuvir v eni sami tableti.
Table 7: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Preglednica 7: Aktivnost ledipasvirja in sofosbuvirja proti himeričnim replikonom Genotip replikonov
Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected.
Klinično pomembnih medsebojnih delovanj z ledipasvirjem/sofosbuvirjem, pri katerih bi posredovali encimi CYP450 ali UGT1A1, se ne pričakuje.
Patients treated with vitamin K antagonists
Bolniki, ki se zdravijo z antagonisti vitamina K
* - If a more normalized dose of ribavirin (by weight and renal function) cannot be reached for reasons of tolerability, 24 weeks of Harvoni + ribavirin should be considered in order to minimize the risk for relapse.
* - Če bolj normaliziranega odmerka ribavirina (glede na telesno maso in ledvično funkcijo) ni mogoče doseči zaradi slabega prenašanja zdravila, je treba razmisliti o 24 tednih zdravila Harvoni + ribavirina, da se zmanjša tveganje za relaps.
ANTIARRHYTHMICS Amiodarone
ANTIARITMIKI Amiodaron
Such co-administration is not recommended.
Taka sočasna uporaba ni priporočljiva.
A total of 80 patients (80%) were treatment-naïve, while 20 patients (20%) were treatment-experienced.
Skupaj 80 bolnikov (80 %) še ni bilo predhodno zdravljenih, medtem ko se je 20 bolnikov (20 %) že predhodno zdravljenih.
SVR was the primary endpoint to determine the HCV cure rate which was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment.
SVR je bil primarni opazovani dogodek za ugotovitev stopnje ozdravljenja HCV, ki je bil opredeljen kot RNA HCV manj kot LLOQ 12 tednov po koncu zdravljenja.
The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Silikagelsko sušilno sredstvo je v posebni vrečici ali vsebniku, ki ga ne smete zaužiti.
ESRD Requiring Dialysis
ESRD, zaradi katere je potrebna dializa
Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir.
Zdravila Harvoni se ne sme dati sočasno z drugimi zdravili, ki vsebujejo sofosbuvir.
In rabbit studies exposure to sofosbuvir was 6 times the expected clinical exposure.
V študijah na kuncih je bila izpostavljenost sofosbuvirju 6-krat večja od pričakovane klinične izpostavljenosti.
B For ribavirin dosing recommendations in patients with decompensated cirrhosis, see table 2 below.
B Za priporočila za odmerjanje ribavirina pri bolnikih z dekompenzirano cirozo glejte preglednico 2 spodaj.
f One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis.
f. En bolnik, ki je dosegel virusno obremenitev < LLOQ ob koncu zdravljenja, ni imel izhodiščnih podatkov za NS5A in je bil iz analize izključen.
This is due to liver function changes during treatment with Harvoni.
Razlog za to so spremembe delovanja jeter pri zdravljenju z zdravilom Harvoni.
A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Harvoni compared to subjects with normal renal function, as described in the text below, are provided in Table 20.
Ledvična okvara Povzetek učinka različnih stopenj ledvične okvare na izpostavljenost sestavinam zdravila Harvoni v primerjavi z osebami z normalnim delovanjem ledvic, kot je opisano spodaj, so na voljo v preglednici 20.
1200 mg/day
1.200 mg/dan
• antacids (such as aluminium/magnesium hydroxide or calcium carbonate).
• antacide (kot so aluminijev/magnezijev hidroksid ali kalcijev karbonat).
In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients.
V tem omejenem naboru podatkov klinične varnosti, stopnja neželenih učinkov in smrti ni bila očitno večja od tiste, ki je pričakovana pri bolnikih z ESRD.
In genotype 3-infection, the use of Harvoni (always in combination with ribavirin) should only be considered for patients who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Pri okužbi z genotipom 3 smemo o uporabi zdravila Harvoni (vedno v kombinaciji z ribavirinom) razmišljati le pri bolnikih, ki veljajo za visoko tvegane z vidika kliničnega napredovanja bolezni in pri katerih ni na voljo drugačnih možnosti zdravljenja.
HCV replicons with reduced susceptibility to ledipasvir have been selected in cell culture for genotype 1a and 1b.
Replikoni HCV z zmanjšano dovzetnostjo za ledipasvir so bili izbrani v celični kulturi za genotipa 1a in 1b.
Concerning genotype-specific virological and clinical activity, see section 5.1.
Glede virološke in klinične aktivnosti, specifične za genotip, glejte poglavje 5.1.
Film-coating:
Filmska obloga:
The median terminal half-life of ledipasvir in healthy volunteers following administration of ledipasvir/sofosbuvir in the fasted state was 47 hours.
Mediani končni razpolovni čas za ledipasvir pri zdravih prostovoljcih po uporabi ledipasvirja/sofosbuvirja na tešče je bil 47 ur.
Table 5 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined equivalence boundaries).
V preglednici 5 je seznam ugotovljenih ali možnih klinično pomembnih interakcij med zdravili (pri čemer je bil 90-odstotni interval zaupanja [IZ] razmerja geometričnega povprečja najmanjših kvadratov [GLSM-geometric least-squares mean] znotraj "↔", razširjenimi nad "↑" ali razširjenimi pod "↓" vnaprej določenih mej ekvivalentnosti).
The adverse reactions observed were consistent with those observed in clinical studies of ledipasvir/sofosbuvir in adults (see Table 6).
Neželeni učinki, ki so jih opazili, so bili skladni s tistimi, ki so jih opazili v kliničnih študijah z ledipasvirjem/sofosbuvirjem pri odraslih (glejte preglednico 6).
The safety assessment of Harvoni was mainly based on pooled Phase 3 clinical studies, without a control, in 1952 patients who received Harvoni for 8, 12 or 24 weeks, including 872 patients who received Harvoni in combination with ribavirin.
Ocena varnosti zdravila Harvoni večinoma temelji na združenih podatkih iz kliničnih študij 3. faze brez kontrolne skupine pri 1952 bolnikih, ki so zdravilo Harvoni prejemali 8, 12 ali 24 tednov, vključno z 872 bolniki, ki so zdravilo Harvoni prejemali v kombinaciji z ribavirinom.
• Do not take any other medicine that contains sofosbuvir, one of the active substances in
• Ne jemljite nobenih drugih zdravil, ki vsebujejo sofosbuvir, ki je ena od učinkovin v zdravilu Harvoni.
Unchanged ledipasvir excreted in faeces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose.
Nespremenjeni ledipasvir, ki se je izločil v blatu, je predstavljal povprečno 70 % uporabljenega odmerka, oksidativni presnovek M19 pa je predstavljal 2,2 % odmerka.
The use of Harvoni in children has not yet been studied.
Uporabe zdravila Harvoni pri otrocih niso preučili.
Animal studies do not indicate harmful effects of ledipasvir or sofosbuvir on fertility.
Študije na živalih ne kažejo škodljivih učinkov ledipasvirja ali sofosbuvirja na plodnost.
• if you are awaiting a liver transplant; • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
• če imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal;
Patients with decompensated cirrhosis irrespective of transplant status
Bolniki z dekompenzirano cirozo ne glede na presaditev
If you are taking a proton pump inhibitor, take it at the same time as Harvoni.
Če jemljete zaviralec protonske črpalke, ga vzemite sočasno z zdravilom Harvoni.