natgillin/translations-raw huggingface dataset:
- Do not use this medicine after the expiry date which is stated on the carton and blister packaging after EXP.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem traku poleg oznake "EXP".
OLYSIO is available in packs containing 7 capsules (1 blister) or 28 capsules (4 blisters).
Zdravilo OLYSIO je na voljo v pakiranjih po 7 kapsul (1 pretisni trak) ali po 28 kapsul (4 pretisni
Especially avoid intense or prolonged exposure to sunlight (including tanning devices).
Izogibajte se zlasti intenzivnemu oziroma dolgotrajnemu sončenju (velja tudi za uporabo solarijev).
Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate).
Pomožne snovi z znanim učinkom: ena kapsula vsebuje 78,4 mg laktoze (v obliki laktoze
The majority of the adverse reactions reported were grade 1 in severity.
Večina poročanih neželenih učinkov je bila stopnje jakosti 1.
Other medicines and OLYSIO
Druga zdravila in zdravilo OLYSIO
12 weeks OLYSIO + sofosbuvir (without ribavirin) may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see sections 4.4 and 5.1)
12 tednov OLYSIO + sofosbuvir (brez ribavirina) se lahko pretehta pri bolnikih z ocenjenim majhnim tveganjem za klinično napredovanje bolezni in možnostmi za kasnejše ponovno zdravljenje (glejte poglavji 4.4 in 5.1)
OLYSIO capsules contain lactose monohydrate.
Kapsule zdravila OLYSIO vsebujejo laktozo monohidrat.
* darunavir/ritonavir + 50 mg simeprevir compared to
* darunavir/ritonavir + 50 mg simeprevirja v primerjavi
Simeprevir is extensively bound to plasma proteins ( 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Simeprevir se močno veže na beljakovine v plazmi (> 99,9%), največ na albumin in manj na alfa-1-kisli glikoprotein.
If you take more OLYSIO than you should If you take more OLYSIO than you should, talk to your doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila OLYSIO, kot bi smeli Če ste vzeli več zdravila OLYSIO, kot bi smeli, takoj obvestite zdravnika ali farmacevta.
Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AE14.
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, protivirusna zdravila z neposrednim delovanjem, oznaka ATC: J05AE14
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from OLYSIO therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom OLYSIO, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
It acts against the virus that causes hepatitis C infection, called ‘hepatitis C virus' (HCV).
Deluje proti virusu, ki povzroča hepatitis C in ga imenujemo virus hepatitisa C (HCV).
What you need to know before you take OLYSIO
Kaj morate vedeti, preden boste vzeli zdravilo OLYSIO
Steady-state was reached after 7 days of once daily dosing.
Do stanja dinamičnega ravnovesja je prišlo po 7 dneh odmerjanja enkrat na dan.
- OLYSIO must not be used by itself.
- Zdravila OLYSIO se ne sme uporabljati samostojno.
Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Simeprevir je opredeljen kot snov, ki izpolnjuje kriterije PBT (je obstojen, bioakumulativen in strupen) (glejte poglavje 6.6).
* In a clinical study in Asian patients from China and South-Korea, increased blood ‘bilirubin' levels were reported in more than 1 in 10 people (very common).
* V klinični študiji pri bolnikih azijskega porekla s Kitajske in Južne Koreje so poročali o zvečani koncentraciji bilirubina v krvi pri več kot 1 od 10 bolnikov (zelo pogosto).
Pregnant women should not take OLYSIO unless specifically directed by the doctor.
Nosečnice ne smejo jemati zdravila OLYSIO, razen če se je tako odločil zdravnik.
Do not stop taking OLYSIO unless your doctor tells you to.
Ne prenehajte jemati zdravila OLYSIO, razen če vam ta naroči zdravnik.
* Ketoconazole: pending further ATC classification.
* ketokonazol: oznaka ATC še ni dodeljena.
Eighty-eight percent (n = 93) of the patients were on HIV therapy, most commonly with 2 NRTIs + raltegravir.
Oseminosemdeset odstotkov (n = 93) bolnikov se je zdravilo zaradi okužbe s HIV, najpogosteje z dvema NRTI + raltegravirjem.
Patient individualised dose at the discretion of the physician, according to local clinical practice.
Odmerek, prilagojen posameznemu bolniku po presoji zdravnika glede na lokalne klinične smernice.
The efficacy of OLYSIO has not been studied in patients with HCV genotypes 2, 3, 5 or 6; therefore OLYSIO should not be used in these patients (see section 5.1).
Učinkovitosti zdravila OLYSIO niso preučevali pri bolnikih s HCV genotipa 2, 3, 5 ali 6, zato se zdravila OLYSIO pri teh bolnikih ne sme uporabljati (glejte poglavje 5.1).
This is due to potential liver function changes during treatment with OLYSIO.
Razlog za to so možne spremembe delovanja jeter pri zdravljenju z zdravilom OLYSIO.
The terminal elimination half-life of simeprevir was 10 to 13 hours in healthy subjects and 41 hours in HCV infected patients receiving 200 mg simeprevir.
Končni razpolovni čas izločanja simeprevirja je 10 do 13 ur pri zdravih osebah in 41 ur pri bolnikih, okuženih s HCV, ki prejemajo odmerek 200 mg simeprevirja.
The European Medicines Agency has deferred the obligation to submit the results of studies with simeprevir in one or more subsets of the paediatric population from 3 years to less than 18 years of age in the treatment of chronic viral hepatitis C (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s simeprevirjem za eno ali več podskupin pediatrične populacije pri preiskovancih, ki so stari od 3 do manj kot 18 let za zdravljenje kroničnega virusnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Recommended duration of treatment provided that patient does not meet a stopping rule (see table 3).
Priporočeno trajanje zdravljenja, pod pogojem, da bolnik ne doseže smernic za ukinitev zdravljenja (glejte
Study HPC3021 N = 40 % (n/N)
študija HPC3021 N = 40 % (n/N)
Metabolites identified in faeces were formed via oxidation at the macrocyclic moiety or aromatic moiety or both and by O-demethylation followed by oxidation.
Metaboliti, ki so jih odkrili v blatu, so nastali z oksidacijo na makrociklični ali aromatski skupini ali na obeh in z O-demetilacijo, ki ji sledi oksidacija.
No dose adjustment is necessary based on body weight or body mass index.
Prilagajanje odmerkov na podlagi telesne mase ali indeksa telesne mase ni potrebno.
Unchanged simeprevir in faeces accounted for on average 31% of the administered dose.
Nespremenjeni simeprevir v blatu je predstavljal povprečno 31% danega odmerka.
The 63 enrolled patients had a median age of 51 years (range 24 to 68 years; with 2% above 65 years); 54% were male; 43% had a
63 vključenih bolnikov je imelo mediano starost 51 let (razpon 24 do 68 let; z 2% starejših od 65 let); 54% je bilo moških; 43%
There were no grade 3 or 4 photosensitivity reactions reported and none of the patients discontinued treatment due to photosensitivity reactions.
O fotosenzitivnih reakcijah stopnje 3 ali 4 niso poročali in noben bolnik zdravljenja ni prekinil zaradi fotosenzitivnih reakcij.
The doctor will advise you to stop breast-feeding or to stop taking OLYSIO while breast-feeding.
Zdravnik vam bo svetoval, da prenehate dojiti ali pa prenehate jemati zdravilo OLYSIO, dokler dojite.
C-simeprevir to healthy subjects, the majority of the radioactivity in plasma (up to 98%) was accounted for by unchanged drug and a small part of the radioactivity in plasma was related to metabolites (none being major metabolites).
C označenega simeprevirja zdravim osebam je bilo večino (do 98%) radioaktivnosti v plazmi mogoče pripisati nespremenjeni učinkovini, le majhen del radioaktivnosti v plazmi pa izvira iz presnovkov (pri čemer nobeden od njih ni glavni presnovek).
Patients with mild to moderate rashes should be monitored for possible progression of rash, including the development of mucosal signs or systemic symptoms.
Bolnike z blagim do zmernim izpuščajem je treba spremljati glede pojava napredovanja izpuščaja, vključno z razvojem znakov na sluznici ali sistemskih simptomov.
Do not stop taking OLYSIO
Ne prenehajte jemati zdravila OLYSIO
In order to evaluate the recurrence of hepatocellular carcinoma associated with OLYSIO, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom OLYSIO, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
In pregnant rats, simeprevir concentrations in placenta, fetal liver and foetus were lower compared to those observed in blood.
Pri brejih podganah je bila koncentracija simeprevirja v placenti, plodovih jetrih in plodu nižja od koncentracije v krvi.
Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in
Bolnike, z velikom tveganjem za pojav bradikardije je treba 48 ur neprekinjeno spremljati v ustreznem kliničnem okolju.
Tell your doctor if any of the following applies: - you currently take, or have taken in the last few months, the medicine amiodarone (your doctor may consider alternative treatments if you have taken this medicine) - you take other medicines to treat irregular heart beat or high blood pressure.
- trenutno jemljete ali ste v zadnjih mesecih jemali amiodaron (če ste jamali to zdravilo, bo vaš zdravnik razmislil o drugih možnostih zdravljenja) - jemljete druga zdravila za zdravljenje motenj srčnega ritma ali visokega krvnega tlaka.
Disposal: Read the package leaflet.
Odstranjevanje: glejte navodilo za uporabo.
Studies in animals have shown reproductive effects (see section 5.3).
Rezultati študij pri živalih kažejo učinke na sposobnost razmnoževanja (glejte poglavje 5.3).
The pharmacokinetics of simeprevir in children aged below 18 years have not been investigated.
Farmakokinetike simeprevirja niso raziskovali pri otrocih, mlajših od 18 let.
As liver function may change during treatment with OLYSIO, close monitoring of International Normalised Ratio (INR) values is recommended.
Ker se delovanje jeter v času zdravljenja z zdravilom OLYSIO lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
The HCV RNA thresholds that trigger discontinuation of treatment (i.e., treatment stopping rules) are presented in table 3.
Pražne koncentracije HCV RNK, pri katerih je treba zdravljenje ukiniti, (tj. smernice za ukinitev zdravljenja), so prikazane v preglednici 3.
Read all of this leaflet carefully before you start taking this medicine because it contains
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne
Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease, which is essential for viral replication.
Simeprevir je specifičen zaviralec serinske proteaze HCV NS3/4A, ki je bistvena za replikacijo virusov.
OLYSIO must be taken orally once a day with food (see section 5.2).
Zdravilo OLYSIO je treba jemati peroralno enkrat na dan, skupaj s hrano (glejte poglavje 5.2).
White gelatin capsule of approximately 22 mm in length, marked with “TMC435 150” in black ink.
Bela želatinska kapsula dolžine približno 22 mm z oznako "TMC435 150", natisnjeno s črnim
If the capsule shell is indented or bent - without being broken or opened - the capsule can still
Če pa je kapsula vdrta ali zmečkana, ni pa zlomljena ali odprta, kapsulo lahko uporabite.
In the pooled phase 3 safety data, the majority of the adverse reactions reported during 12 weeks treatment with simeprevir were grade 1 to 2 in severity.
V bazi združenih podatkov o varnosti študij faze 3 je večina neželenih učinkov, poročanih v 12 tednih zdravljenja s simeprevirjem, dosegla stopnjo jakosti 1 do 2.
This interaction study has been performed with a dose higher than the recommended dose for simeprevir assessing the maximal effect on the co-administered drug.
V tej interakcijski študiji so uporabljali večji odmerek simeprevirja od priporočenega, da bi lahko ocenili največji učinek na sočasno uporabljano zdravilo.
Treatment with OLYSIO should be initiated and monitored by a physician experienced in the
Zdravljenje z zdravilom OLYSIO mora uvesti in spremljati zdravnik z izkušnjami pri zdravljenju
Compared to intake without food, administration of simeprevir with food to healthy subjects increased the AUC by 61% after a high-fat, high-caloric (928 kcal) and 69% after a normal caloric (533 kcal) breakfast, and delayed the absorption by 1 hour and 1.5 hours, respectively.
V primerjavi z vnosom zdravila brez hrane je pri zdravih osebah odmerjanje simeprevirja skupaj s hrano povečalo AUC za 61% po zaužitju zelo kaloričnega zajtrka (928 kcal) z veliko vsebnostjo maščob, za 69% pa po zaužitju zajtrka z normalnim številom kalorij (533 kcal), pri čemer je prišlo do zakasnitve absorpcije za 1 uro oziroma za 1, 5 ure.
Ελλάδα
Po enkratnem
Due to the long elimination 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 OLYSIO combination treatment with sofosbuvir.
Zaradi dolgega razpolovnega časa izločanja amiodarona, je potrebno tudi ustrezno spremljanje bolnikov, ki so v preteklih mesecih prenehali jemati amiodaron in bodo začeli s kombiniranim zdravljenjem z zdravilom OLYSIO in sofosbuvirjem.
Interaction studies have been performed in healthy adults with the recommended dose of 150 mg simeprevir once daily unless otherwise noted.
Interakcijske študije so izvajali pri zdravih odraslih s priporočenim odmerkom 150 mg simeprevirja enkrat na dan, kjer ni navedeno drugače.
peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin); SMV = simeprevir.
peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (odmerjanje ribavirina glede na telesno maso, dvakrat na dan, v skladu s povzetkom glavnih značilnosti zdravila za ribavirin); SMV = simeprevir.
Table 4: Interactions and dose recommendation with other medicinal products Recommendation for co-administration
Preglednica 4: Interakcije in priporočila za odmerjanje z drugimi zdravili
Female patients of childbearing potential must use an effective form of contraception (see section 4.6).
Bolnice v rodnem obdobju morajo uporabljati učinkovito obliko kontracepcije (glejte poglavje 4.6).
150 mg simeprevir 12 weeks % (n/N)
150 mg simeprevir 12 tednov % (n/N)
Opaque polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PE/PVDC) aluminium push-through blister strips of 7 capsules.
Neprozoren pretisni trak iz polivinilklorida/polietilena/polivinilidenklorida (PVC/PE/PVDC) z aluminijastim pokritjem, skozi katerega se potisne kapsulo.
- If it is less than 12 hours until your next dose, skip the missed dose.
- Če je do naslednjega odmerka manj kot 12 ur, izpustite pozabljeni odmerek.
Simeprevir is not a clinically relevant inhibitor of cathepsin A enzyme activity.
Simeprevir ni klinično pomemben zaviralec encimske dejavnosti
While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Čeprav ni pričakovati nobenih sprememb farmakokinetike, se pri vseh antagonistih vitamina K priporoča natančno spremljanje vrednosti INR.
The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food.
Priporočeno odmerjanje zdravila OLYSIO je ena 150 mg kapsula enkrat na dan skupaj s hrano.
Only grade 1 and 2 events were reported and there were no events leading to discontinuation of any of the study drugs.
Poročani so bili samo neželeni učinki stopnje 1 in 2, od katerih noben primer ni vodil v prekinitev zdravljenja s katerim koli študijskim zdravilom.
Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
Celokupno trajanje zdravljenja s peg-IFN-alfa in RBV je bilo odvisno od odziva.
Double-blind, randomised, placebo-controlled, except for studies C212 and HPC3011 which were open-label, single arm.
Dvojno slepa, randomizirana, nadzorovana s placebom, z izjemo študij C212 in HPC3011, ki sta bili odprti študiji z eno
- The other ingredients are sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) and shellac (E904).
- Druge sestavine zdravila so natrijev lavrilsulfat, magnezijev stearat, koloidni brezvodni silicijev dioksid, premreženi natrijev karmelozat, laktoza monohidrat, želatina, titanov dioksid (E171), črni železov oksid (E172) in šelak (E904).
In vitro, simeprevir induced a phototoxic response on BALB/c 3T3 fibroblasts after UVA exposure, in the absence and presence of protein supplements.
In vitro je simeprevir sprožil fototoksičen odziv pri fibroblastih BALB/c 3T3 po izpostavljenosti UVA svetlobi ob dodatku beljakovin ali brez njih.
No serious adverse reactions
O resnih neželenih učinkih
OLYSIO has no or negligible influence on the ability to drive and use machines.
Zdravilo OLYSIO nima vpliva ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
It is not known whether simeprevir or its metabolites are excreted in human milk.
Ni znano, ali se simprevir oziroma njegovi presnovki izločajo v materinem mleku.
Common: may affect up to 1 in 10 people: - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver)* - being sensitive to sunlight (photosensitivity)
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov: - zvečana koncentracija bilirubina v krvi (bilirubin je barvilo, ki nastaja v jetrih)* - povečana občutljivost kože na sončno svetlobo (fotosenzitivnost)
The most frequently reported adverse reactions (incidence ≥ 5% following 12 or 24 weeks of treatment) were rash, pruritus, constipation and photosensitivity reaction (see section 4.4).
Najpogosteje poročani neželeni učinki (s pogostnostjo ≥ 5% po 12 ali 24 tednih zdravljenja) so bili izpuščaj, srbenje, zaprtje in fotosenzitivne reakcije (glejte poglavje 4.4).
When taking OLYSIO combination treatment, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - notice yellowing of your skin or eyes
Obvestite zdravnika, če se med kombiniranim zdravljenjem z zdravilom OLYSIO pojavijo naslednji simptomi, ki lahko kažejo na poslabšanje jetrne bolezni: - opazite, da so vaša koža ali oči postali rumeni
The one patient with on-treatment failure discontinued treatment early due to an adverse event.
En bolnik z neuspehom v času zdravljenja je zdravljenje kmalu zaključil zaradi neželenega učinka.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
During your treatment with OLYSIO, use appropriate sun protection (such as a sun hat, sunglasses and sunscreen).
Med zdravljenjem z zdravilom OLYSIO uporabljajte ustrezna zaščitna sredstva (kot so zaščitno pokrivalo, sončna očala in zaščitne kreme).
In vitro experiments with human Caco-2 cells indicated that simeprevir is a substrate of P-gp.
In vitro testiranja na človeških celicah Caco-2 so pokazala, da je simeprevir substrat P-glikoproteina
In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a
V Evropi je bila prevalenca manjša, 19% (73/377) pri bolnikih s HCV genotipa 1a in 0,3% (3/877) pri bolnikih s HCV
The safety and efficacy of OLYSIO in children aged below 18 years have not yet been established.
Varnost in učinkovitost zdravila OLYSIO pri otrocih, mlajših od 18 let, še nista bili dokazani.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 0.80 - 1.25 range.
Smer puščice (↑ = zvečanje, ↓ = zmanjšanje, ↔ = ni spremembe) za vsak farmakokinetični parameter temelji na 90% intervalu zaupanja za razmerje geometrične sredine, ki je v okviru razpona 0,80 - 1,25 (↔) ali pod (↓) oziroma nad (↑) njim.
Table 12: Demographics and baseline characteristics (studies HPC3017 and HPC3018) HPC3017 N = 310
Preglednica 12: Demografske in izhodiščne značilnosti (študiji HPC3017 in HPC3018) HPC3017 N = 310
Studies carried out in rats did not reveal significant findings on fertility, embryo-fetal development or pre- and post-natal development at any of the tested doses (corresponding to a systemic exposure in rats similar or lower than that observed in humans at the recommended dose of 150 mg once daily).
Rezultati študij na podganah ne kažejo pomembnega vpliva na plodnost, razvoj zarodka oziroma ploda in na prenatalni ter postnatalni razvoj pri nobenem od testiranih odmerkov (glede na sistemsko izpostavljenost pri podganah, ki je bila podobna ali manjša kot izpostavljenost pri ljudeh pri uporabi priporočenega odmerka 150 mg enkrat na dan).
OLYSIO has not been studied in HCV infected patients with severe renal impairment (creatinine clearance below 30 ml/min) or end stage renal disease, including patients requiring haemodialysis.
Zdravila OLYSIO niso proučevali pri bolnikih, okuženih s HCV in hudo okvaro ledvic (očistek kreatinina manj kot 30 ml/min) ali končno ledvično odpovedjo, vključno z bolniki, ki potrebujejo hemodializo.
OLYSIO must be used in combination with other medicinal products for the treatment of CHC (see section 5.1).
Zdravilo OLYSIO je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje CHC (glejte poglavje 5.1).
No dose adjustment is necessary based on gender.
Prilagajanje odmerkov na podlagi spola ni potrebno.
If you are pregnant, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali
In a phase 3 study conducted in China and South-Korea, the mean plasma exposure of simeprevir in Asian HCV infected patients was 2.1-fold higher compared to non-Asian HCV infected patients in a pooled phase 3 population from global studies.
V študiji faze 3, izvedeni na Kitajskem in v Južni Koreji, je bila povprečna izpostavljenost simeprevirju pri bolnikih azijskega porekla, okuženih s HCV, 2,1-krat večja kot pri populaciji bolnikov v združenih globalnih študijah faze 3, okuženimi s HCV, ki niso bili azijskega porekla.
All patients receiving OLYSIO combination treatment with sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they
Vse bolnike, ki prejemajo zdravilo OLYSIO in sofosbuvir v kombinaciji z amiodaronom (z ali brez drugih zdravil, ki zmanjšujejo srčno frekvenco) je treba opozoriti na simptome bradikardije in srčnega bloka in jim svetovati naj v primeru pojava teh simptomov takoj poiščejo zdravniško pomoč.