natgillin/translations-raw huggingface dataset:
No dose adjustment of Sovaldi is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Pri bolnikih z blago, zmerno ali hudo jetrno okvaro (stopnja A, B ali C po Child-Pugh-Turcotteu [CPT]) odmerka zdravila Sovaldi ni treba prilagajati (glejte poglavje 5.2).
Sovaldi 400 mg film-coated tablets
IME ZDRAVILA Sovaldi 400 mg filmsko obložene tablete
Tenofovir disoproxilf (245 mg once daily)d
Dizoproksiltenofoviratf (245 mg enkrat na dan)d
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Sovaldi.
Po začetku jemanja zdravila Sovaldi morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
(n = 327)
12 tednov (n = 327)
Table 2: Ribavirin dose modification guideline for co-administration with Sovaldi in adults
Preglednica 2: Smernice za prilagajanje odmerka ribavirina pri sočasnem dajanju z zdravilom Sovaldi pri odraslih
How to store Sovaldi
Shranjevanje zdravila Sovaldi
Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Defosforilacija povzroči nastanek nukleozidnega presnovka GS-331007, ki ga ni mogoče učinkovito ponovno refosforilati in ki in vitro ni aktiven proti HCV. Sofosbuvir in GS-331007 nista substrata ali zaviralca
Sofosbuvir is not a substrate for hepatic uptake transporters, organic anion-transporting polypeptide (OATP) 1B1 or 1B3, and organic cation transporter (OCT) 1.
(OATP-organic anion-transporting polypeptide) 1B1 ali 1B3 in prenašalca organskih kationov (OCT
Study 4062 was an open-label study that evaluated a fixed dose combination of sofosbuvir and velpatasvir in 59 HCV-infected patients with ESRD requiring dialysis.
Študija 4062 je bila odprta študija, v kateri so ocenili kombinacijo s fiksim odmerkom sofosbuvirja in ledipasvirja pri 59 bolnikih z okužbo s HCV in ESRD, zaradi katere je potrebna dializa.
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Sovaldi.
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Sovaldi,
Such co-administration is not recommended (see also section 4.5).
Taka sočasna uporaba ni priporočljiva (glejte poglavje 4.5).
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir .
Med kliničnim razvojem sofosbuvirja je bila sočasna uporaba amiodarona omejena.
No effects on foetal development have been observed in rats and rabbits at the highest doses tested.
Pri najvišjih testiranih odmerkih pri podganah in kuncih niso opazili učinkov na razvoj ploda.
Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in patients who are interferon intolerant, ineligible or unwilling.
Odrasli, ki niso prenašali interferona, niso bili primerni ali voljni - POSITRON (študija 107) Študija POSITRON je bila randomizirana, dvojno slepa, s placebom kontrolirana študija, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom (n = 207) v primerjavi s placebom
Sovaldi in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Pri prejemnikih presajenih jeter se priporoča 24-tedenska uporaba zdravila Sovaldi v kombinaciji z ribavirinom.
• diarrhoea, feeling sick (nausea), being sick (vomiting)
• driska, siljenje na bruhanje (navzea), bruhanje
Sovaldi + ribavirina for 12 weeks b
Sovaldi + ribavirina 12 tednovb
No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Pri sočasni uporabi sofosbuvirja in norgestimata/etinilestradiola odmerka norgestimata/etinilestradiola ni treba prilagajati.
Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
Za dodatne informacije o zmanjšanju in/ali ukinitvi odmerka peginterferona alfa glejte povzetek glavnih značilnosti zdravila za peginterferon alfa.
Hepatic impairment
Predhodno nezdravljeni
After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Po enkratnem 400-miligramskem peroralnem odmerku [14C]-sofosbuvirja je sofosbuvir prispeval približno 4 % sistemske izpostavljenosti z zdravilom povezanega materiala (vsota vrednosti AUC
Table 16 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
V preglednici 16 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in izpostavljenost predhodnemu zdravljenju HCV.
≥2 g/dL decrease in haemoglobin during any 4 week treatment period
Hemoglobin pri bolnikih s stabilno boleznijo srca v anamnezi zmanjšanje hemoglobina za ≥ 2 g/dl v 4-tedenskem obdobju zdravljenja
↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC) ↔ GS-331007 (TPV ali
• fever, chills, flu-like symptoms
• povečana telesna temperatura, mrzlica, gripi podobni simptomi
The safety profile of sofosbuvir and ribavirin in liver transplant adult recipients with chronic hepatitis C was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Profil varnosti sofosbuvirja in ribavirina pri odraslih prejemnikih presajenih jeter s kroničnim hepatitisom C je bil podoben tistemu, ki so ga opazili pri bolnikih, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
What Sovaldi is and what it is used for What you need to know before you take Sovaldi How to take Sovaldi
Kaj morate vedeti, preden boste vzeli zdravilo Sovaldi Kako jemati zdravilo Sovaldi
Sovaldi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Zdravilo Sovaldi je kontraindicirano v kombinaciji s fenobarbitalom in fenitoinom (glejte poglavje 4.3).
In addition, S282R and L320F substitutions were detected on treatment by deep sequencing in a pre-transplant subject with a partial treatment response.
S podatki karakterizacije strukture genoma med zdravljenjem so pri osebah pred presaditvijo z delnim odzivom na zdravljenje odkrili tudi substituciji S282R in L320F.
Table 14 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
V preglednici 14 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in odziv na predhodno zdravljenje HCV.
IMMUNOSUPPRESSANTS Ciclosporine (600 mg single dose)
Ciklosporine (600 mg enkratni odmerek)
Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected patients.
V primerjavi z zdravimi osebami (n = 284) je bila pri bolnikih, okuženih s HCV, vrednost AUC0-24 za sofosbuvir za 57 % višja in vrednost AUC0-24 za GS-331007 za 39 % nižja.
Genotype 1 treatment-naïve SOF+RBV 24 weeks (n = 114)
Genotip 1 predhodno nezdravljeni SOF+RBV 24 tednov (n = 114)
* The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food.
1.200 mg/dan * Odmerek ribavirina na dan temelji na telesni masi in se daje peroralno s hrano, razdeljen na dva odmerka.
Safety data are limited in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) in
The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥50 and <80 mL/min/1.73 m2), moderate (eGFR ≥30 and <50 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir, relative to patients with normal renal function (eGFR >80 mL/min/1.73 m2).
Farmakokinetiko sofosbuvirja so preučili pri bolnikih, negativnih za HCV, z blago (eGFR ≥ 50 in < 80 ml/min/1,73 m2), zmerno (eGFR ≥ 30 in < 50 ml/min/1,73m2) in hudo ledvično okvaro
Table 18 presents the subgroup analysis by genotype for cirrhosis.
V preglednici 18 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo.
Otherc a. The efficacy analysis includes 6 patients with recombinant genotype 2/1 HCV infection.
Drugoc a. Analiza učinkovitosti vključuje 6 bolnikov z okužbo s HCV z rekombinantnim genotipom 2/1.
Table 16: SVR12 rates for selected subgroups by genotype in study VALENCE
Preglednica 16: Stopnje SVR12 za izbrane podskupine po genotipu v študiji VALENCE Genotip 2
Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms
zelo pogosti artralgija, mialgija pogosti artralgija, bolečine v hrbtu, mišični spazmi, mialgija bolečine v hrbtu, mišični spazmi
The efficacy of sofosbuvir in HCV-infected patients aged 12 to <18 years was evaluated in a Phase 2, open label clinical trial that enrolled 50 patients with genotype 2 (n = 13) or genotype 3 (n = 37) chronic HCV infection.
Učinkovitost sofosbuvirja pri bolnikih, okuženih s HCV, starih 12 do < 18 let, so ocenili v odprtem kliničnem preskušanju 2. faze, v katero je bilo vključenih 50 bolnikov s kronično okužbo s HCV
Co-administration of such medicinal products is not recommended with Sovaldi (see section 4.5).
Sočasna uporaba teh zdravil z zdravilom Sovaldi ni priporočljiva (glejte poglavje 4.5).
Very common haemoglobin decreased anaemia, neutropenia, lymphocyte count decreased, platelet count decreased
Bolezni krvi in limfatičnega sistema zelo pogosti znižana raven hemoglobina anemija, nevtropenija, znižano število limfocitov, znižano število trombocitov pogosti anemija
Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection
Zdravljenje brez interferona za okužbo s HCV genotipa 1, 4, 5 in 6
Table 14: SVR12 rates for selected subgroups by genotype in study FUSION
Preglednica 14: Stopnje SVR12 za izbrane podskupine po genotipu v študiji FUSION Genotip 2
Sofosbuvir in a fixed dose combination with ledipasvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Kombinacijo s fiksnim odmerkom sofosbuvirja in ledipasvirja so v odprti študiji (študija 0154) 12 tednov dajali 18 bolnikom s CHC genotipa 1 in hudo okvaro ledvic.
Treatment-experienced (VALENCE)
Predhodno nezdravljeni in predhodno zdravljeni odrasli - VALENCE (študija 133)
Treatment-naïve (QUANTUMb and 11-1-0258b) SOF+RBV 24 weeks
Predhodno nezdravljeni (QUANTUMb in 11-1-0258b)
24 weeks (n = 28)
12 tednov (n = 68)
If sofosbuvir is used in combination with peginterferon alfa, and a patient has a serious adverse reaction potentially related to this medicinal product, the peginterferon alfa dose should be reduced or discontinued.
Če se sofosbuvir uporablja v kombinaciji s peginterferonom alfa in ima bolnik resne neželene učinke,
HCV/HIV co-infected adult patients - PHOTON-1 (study 123) Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in patients with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Klinična učinkovitost in varnost pri posebnih populacijah Odrasli bolniki s sočasno okužbo z virusoma HCV in HIV - PHOTON-1 (študija 123) Sofosbuvir so preučili v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost 12- ali 24-tedenskega zdravljenja s sofosbuvirjem in ribavirinom pri bolnikih s kroničnim hepatitisom C
• shortness of breath when exercising
• zasoplost pri telesni vadbi
The dose of ribavirin, when used in combination with Sovaldi is weight-based (<75 kg = 1,000 mg and ≥75 kg = 1,200 mg) and administered orally in two divided doses with food.
(< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg) in se daje peroralno v dveh razdeljenih odmerkih s hrano.
Sovaldi is contraindicated with carbamazepine (see section 4.3).
Zdravilo Sovaldi je kontraindicirano v kombinaciji s karbamazepinom (glejte poglavje 4.3).
Contents of the pack and other information
Shranjevanje zdravila Sovaldi Vsebina pakiranja in dodatne informacije
Sovaldi is contraindicated with rifampicin (see section 4.3).
Zdravilo Sovaldi je kontraindicirano v kombinaciji z rifampicinom (glejte poglavje 4.3).
Co-administration with such medicinal products is not recommended with Sovaldi (see section 4.4).
Sočasna uporaba teh zdravil z zdravilom Sovaldi ni priporočljiva (glejte poglavje 4.4).
Sovaldi [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Sovaldi [samo zunanja ovojnina]
The sofosbuvir-associated resistance substitution S282T was not detected in any of these patients by deep sequencing or population sequencing.
Substitucije S282T, povezane z odpornostjo na sofosbuvir, s karakterizacijo strukture genoma ali karakterizacijo nukleotidnih sledi genoma niso odkrili pri nobenem od teh bolnikov.
The safety profile of sofosbuvir and ribavirin in HCV infected adult patients prior to liver transplantation was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Profil varnosti sofosbuvirja in ribavirina pri odraslih bolnikih, okuženih z virusom HCV, pred presaditvijo jeter, je bil podoben tistemu, ki so ga opazili pri bolnikih, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
Otherc a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Drugoc a. Analiza učinkovitosti vključuje 3 bolnike z okužbo s HCV z rekombinantnim genotipom 2/1.
Sovaldi is not recommended for administration as monotherapy and should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection.
Zdravilo Sovaldi je indicirano v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C
Treatment-naïve and previously treated adults - VALENCE (study 133) VALENCE was a Phase 3 study that evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve patients or patients who did not achieve SVR with prior interferon-based treatment, including patients with compensated cirrhosis.
VALENCE je bila študija 3. faze, v kateri so ocenili sofosbuvir v kombinaciji z ribavirinom na podlagi telesne mase za zdravljenje okužbe s HCV genotipa 2 ali 3 pri predhodno nezdravljenih bolnikih ali pri bolnikih, ki niso dosegli SVR s predhodnim zdravljenjem na podlagi interferona, vključno z bolniki s kompenzirano cirozo.
Sofosbuvir retained activity against the NS5B substitutions L159F and L320F associated with resistance to other nucleoside inhibitors.
Replikoni HCV z izraženo substitucijo S282T, povezano z odpornostjo na sofosbuvir, so bili v celoti dovzetni za druge razrede učinkovin proti HCV. Sofosbuvir je ohranil aktivnost proti substitucijama NS5B L159F in L320F, povezanima z odpornostjo na druge nukleozidne zaviralce.
No dose adjustment of sofosbuvir is recommended for patients with mild, moderate and severe hepatic impairment (see section 4.2).
Pri bolnikih z blago, zmerno in hudo jetrno okvaro prilagajanje odmerka sofosbuvirja ni potrebno (glejte poglavje 4.2).
Clinical studies in patients with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Klinične študije pri bolnikih s kroničnim hepatitisom C genotipa 2 in 3
Table 11: Response rates in study POSITRON
Preglednica 11: Stopnje odziva v študiji POSITRON SOF+RBV
No dose adjustment of sofosbuvir or emtricitabine is required when sofosbuvir and emtricitabine are used concomitantly.
Pri sočasni uporabi sofosbuvirja in emtricitabina odmerka sofosbuvirja ali emtricitabina ni treba prilagajati.
Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA)
↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57) Cmin (n/n)
The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1).
Klinični podatki, ki bi podprli uporabo zdravila Sovaldi pri bolnikih z okužbo s HCV genotipa 5 in 6,
Clinical studies in patients with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve adult patients - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 1, 4, 5 or 6 HCV infection.
Odrasli bolniki, ki se predhodno še niso zdravili - NEUTRINO (študija 110) Študija NEUTRINO je bila odprta študija z enim krakom, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem v kombinaciji s peginterferonom alfa 2a in ribavirinom pri zdravljenju bolnikov z okužbo s HCV genotipa 1, 4, 5 ali 6, ki se predhodno še niso zdravili.
Metabolism and nutrition disorders: Very common decreased appetite
zelo pogosti zmanjšan apetit pogosti zmanjšanje telesne mase
The primary endpoint of the study was post-transplant virologic response (pTVR, HCV RNA <LLOQ at 12 weeks post-transplant).
Primarni opazovani dogodek študije je bil virološki odziv po presaditvi (pTVR-post-transplant virologic response;
Table 23: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Preglednica 23: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipov 4, 5 in 6
Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C.
Zdravilo Sovaldi vedno jemljite v kombinaciji z drugimi zdravili proti hepatitisu C. Težave z ledvicami
Impact of DAA therapy on drugs metabolized by the liver
Vpliv zdravil z direktnim delovanjem na viruse (DAA - direct-acting antivirals) na zdravila, ki se presnavljajo v jetrih
• Decide what other medicines you should take with Sovaldi and for how long;
• odloči, katera druga zdravila morate jemati z zdravilom Sovaldi in kako dolgo • potrdi, da je bilo pri vas zdravljenje učinkovito in da ste brez virusa hepatitisa C
Treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection
Predhodno zdravljeni bolniki z okužbo s HCV genotipa 1, 4, 5 in 6
b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
b. Razmisliti je treba o možnem podaljšanju trajanja zdravljenja na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (npr. napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28B, predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom).
SOF+RBV 24 weeks (n = 250)
SOF+RBV 24 tednov (n = 250)
SOF+PEG+RBV 12 weeks
SOF+PEG+RBV 12 tednov
The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and 0.085 ± 0.034 μM for genotype 3a (n = 106).
Povprečje ± SD EC50 za sofosbuvir proti himeričnim replikonom, ki kodirajo zaporedje NS5B iz kliničnih izolatov, je bilo 0,068 ± 0,024 μM za genotip 1a (n = 67),
SVR12 to SVR24 concordance
Ujemanje med SVR12 in SVR24
PEG+RBV 24 weeks (n = 176)
PEG+RBV 24 tednov (n = 176)
No dose adjustment of sofosbuvir or methadone is required when sofosbuvir and methadone are used concomitantly.
Pri sočasni uporabi sofosbuvirja in metadona odmerka sofosbuvirja ali metadona ni treba prilagajati.
The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected adult patients was similar to that observed in mono-infected HCV patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Profil varnosti sofosbuvirja in ribavirina pri odraslih bolnikih, sočasno okuženih z virusoma HCV in HIV, je bil podoben tistemu, ki so ga opazili pri bolnikih, okuženih samo z virusom HCV, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
SOF+RBV 16 weeks
SOF+RBV 16 tednov
Dose modification in adults Dose reduction of Sovaldi is not recommended.
Zmanjšanje odmerka zdravila Sovaldi se ne priporoča.
GS 331007 ↔ Cmax 1.04 (0.97, 1.11) ↔ AUC 0.99 (0.94, 1.04) Cmin (NA)
GS 331007 ↔ Cmax 1,04 (0,97; 1,11) ↔ AUC 0,99 (0,94; 1,04) Cmin (n/n) (indukcija P-gp)
SOF+RBV 24 weeks
SOF+RBV 24 tednov
The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 6).
Pri uporabi sofosbuvirja v kombinaciji z ribavirinom ali v kombinaciji s peginterferonom alfa in ribavirinom so ugotovili naslednje neželene učinke zdravila (preglednica 6).
Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
↑ AUC 1,34 (1,12; 1,59) Cmin (n/n)
Not applicable.
Niso voljni
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) Yellow iron oxide (E172)
smukec (E553b) rumeni železov oksid (E172)
Norgestrel ↔ Cmax 1.18 (0.99, 1.41)
↔ Cmax 1,18 (0,99; 1,41)
Co-administration of Sovaldi with rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Sovaldi z rifapentinom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
Renal impairment No dose adjustment of Sovaldi is required for patients with mild or moderate renal impairment.
Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro odmerka zdravila Sovaldi ni treba prilagajati.
No dose adjustment of sofosbuvir or rilpivirine is required when sofosbuvir and rilpivirine are used concomitantly.
Pri sočasni uporabi sofosbuvirja in rilpivirina odmerka sofosbuvirja ali rilpivirina ni treba prilagajati.
Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Razmisliti je treba o zdravljenju teh bolnikov in morebitnem podaljšanju trajanja zdravljenja s sofosbuvirjem, peginterferonom alfa in ribavirinom na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28b).
Ethinyl estradiol ↔ Cmax 1.14 (0.96, 1.36)
↔ Cmax 1,14 (0,96; 1,36)
Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Pri uporabi režimov zdravljenja, ki vključujejo sofosbuvir v kombinaciji z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
PEG+RBV 24 weeks (n = 243)
PEG+RBV 24 tednov (n = 243)
Sofosbuvir is a nucleotide prodrug that is extensively metabolised.
5.2 Farmakokinetične lastnosti Sofosbuvir je nukleotidno predzdravilo, ki se obsežno presnavlja.
GS-331007 ↓ Cmax 0.77 (0.70, 0.84) ↔ AUC 0.84 (0.76, 0.92) Cmin (NA)
↓ Cmax 0,77 (0,70; 0,84) ↔ AUC 0,84 (0,76; 0,92) Cmin (n/n)
SOF+RBV 16 weeks (n = 98)a
SOF+RBV 16 tednov (n = 98)a