natgillin/translations-raw huggingface dataset:
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 farmacevtom, preden vzamete to zdravilo.
ULN = Upper Limit of Normal. 
ZMN = zgornja meja normalnih vrednosti.
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.
3 Recommended duration of treatment provided that patient does not meet a stopping rule (see table 3). 
3 Priporočeno trajanje zdravljenja, pod pogojem, da bolnik ne doseže smernic za ukinitev zdravljenja (glejte preglednico 3).
EU/1/14/924/002 (28 capsules) 
EU/1/14/924/002 (28 kapsul)
Amiodarone 
amiodaron
What OLYSIO is and what it is used for What you need to know before you take OLYSIO How to take OLYSIO 
Kaj je zdravilo OLYSIO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo OLYSIO Kako jemati zdravilo OLYSIO
In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a and 0.3% (3/877) in genotype 1b. 
V Evropi je bila prevalenca manjša, 19% (73/377) pri bolnikih s HCV genotipa 1a in 0,3% (3/877) pri bolnikih s HCV genotipa 1b.
Amylase and lipase elevations were not associated with pancreatitis. 
Zvečanje koncentracij amilaze in lipaze ni bilo povezano s pankreatitisom.
1 WHO worst toxicity grades 1 to 4. 
1 največja stopnja toksičnosti po SZO 1 do 4
Hyperbilirubinemia Grade 1 
Hiperbilirubinemija stopnja 1
Study HPC3007 
Študija HPC3007
The long-term clinical impact of the emergence or persistence of simeprevir-resistance-associated substitutions is unknown. 
Dolgoročni klinični pomen pojavljanja oziroma vztrajanja substitucij, ki povzročajo odpornost na simeprevir, ni znan.
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 trakovi).
5 Comparison based on historic controls. 
5 Primerjava s podatki zgodovinskih kontrol.
C206 (ASPIRE; Phase 2) 
C206 (ASPIRE; faza 2)
The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). 
(≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
ANTIHISTAMINES Astemizole Terfenadine 
ANTIHISTAMINIKI astemizol terfenadin
Lipase Grade 1 
Lipaza stopnja 1
C208 - C216 (QUEST-1 and QUEST-2; 
C208 - C216 (QUEST-1 in QUEST-2; faza 3)
Table 4: Interactions and dose recommendation with other medicinal products Medicinal products by therapeutic areas 
Preglednica 4: Interakcije in priporočila za odmerjanje z drugimi zdravili
Genotype 1 (N = 9) Genotype 2 (N = 6) Genotype 3 (N = 8) Genotype 4 (N = 8) Genotype 5 (N = 7) Genotype 6 (N = 8) 
genotip 1 (N = 9) genotip 2 (N = 6) genotip 3 (N = 8) genotip 4 (N = 8) genotip 5 (N = 7) genotip 6 (N = 8)
4 Patient individualised dose at the discretion of the physician, according to local clinical practice. 
4 Odmerek, prilagojen posameznemu bolniku po presoji zdravnika glede na lokalne klinične smernice.
- If you are a woman, you must not become pregnant during treatment and for several months afterwards. 
- Če ste ženska, ne smete zanositi med zdravljenjem in še nekaj mesecev po zaključku zdravljenja.
Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL) 
Srednja (SE) sprememba v HCV RNA na dan 7/8 (log10 i.e./ml)
* darunavir/ritonavir + 50 mg simeprevir compared to 150 mg simeprevir alone. 
* darunavir/ritonavir + 50 mg simeprevirja v primerjavi s 150 mg simeprevirja samostojno
Any substitution at NS3 position 43, 80, 122, 155, 156, or 1682 
katera koli substitucija na položaju NS3 43, 80, 122, 155, 156 ali 1682
How to remove capsule Press either edge of the pocket to push the capsule through the foil, as shown. 
Kako iztisniti kapsulo iz žepka Kot je prikazano na sliki, pritisnite na rob žepka in potisnite kapsulo skozi folijo.
4.6 Fertility, pregnancy and lactation 
4.6 Plodnost nosečnost in dojenje
12 weeks N = 286 
12 tednov n = 286
Patients with cirrhosis1 
Bolniki s cirozo1
NARCOTIC ANALGESICS Methadone7 
OPIOIDNI ANALGETIKI metadon7
Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience: - shortness of breath - light-headedness - palpitations - fainting. 
Takoj obvestite zdravnika če jemljete zdravilo OLYSIO, sofosbuvir in katerokoli zdravilo za zdravljenje težav s srcem in se med zdravljenjem pojavijo: - zasoplost - omotica - palpitacije - omedlevica.
The capsule should be swallowed as a whole. 
Kapsule je treba pogoltniti cele.
None of the patients discontinued treatment due to ‘blood bilirubin increased'. 
Noben bolnik pa ni prekinil zdravljenja zaradi 'zvečanja koncentracije bilirubina v krvi'.
Clarithromycin Telithromycin 
klaritromicin telitromicin
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 barvilom.
HMG CO-A REDUCTASE INHIBITORS Rosuvastatin 
ZAVIRALCI REDUKTAZE HMG-CoA rosuvastatin
Oral: 0.075 mg/kg Intravenous: 
0,075 mg/kg intravenski:
If you forget to take OLYSIO - If it is more than 12 hours until your next dose, take the missed dose as soon as possible with food. 
Če ste pozabili vzeti zdravil OLYSIO - Če je do naslednjega odmerka več kot 12 ur, vzemite pozabljeni odmerek čimprej skupaj s hrano.
If the capsule shell is indented or bent - without being broken or opened - the capsule can still be used. 
Če pa je kapsula vdrta ali zmečkana, ni pa zlomljena ali odprta, kapsulo lahko uporabite.
Dexlansoprazole Esomeprazole Lansoprazole Pantoprazole Rabeprazole 
dekslansoprazol esomeprazol lansoprazol pantoprazol rabeprazol
Environmental Risk Assessment (ERA) 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).
The clinical relevance of this difference in viral breakthrough rates is unknown. 
Klinični pomen razlik v stopnjah virusnega preboja med različnimi podskupinami ni znan.
2 Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event. 
2 Med 3 bolniki z neuspehom v času zdravljenja sta imela 2 bolnika virusni preboj, en bolnik pa je zdravljenje kmalu zaključil zaradi neželenega učinka.
Co-administration is not recommended. 
Sočasna uporaba ni priporočena.
INFORMATION IN BRAILLE olysio 150 mg 
PODATKI V BRAILLOVI PISAVI olysio 150 mg
Hepatitis B virus (HBV) co-infection 
Sočasna okužba z virusom hepatitisa B (HBV)
HCV genotype 1b 
HCV genotipa 1b
Study1 
Študija1
ANTITUSSIVE Dextromethorphan (DXM) 
ANTITUSIKI dekstrometorfan (DXM)
Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Hispanic 
Starost (leta) mediana (razpon) % nad 65 let Moški Rasa belci črna rasa/afroameričani
Female patients of childbearing potential and male patients with female partners of childbearing potential must use an effective form of contraception during treatment with ribavirin and after completion of ribavirin treatment for a duration as specified in the Summary of Product Characteristics for ribavirin. 
Bolnice, ki so v rodni dobi, in bolniki s partnerkami v rodni dobi morajo uporabljati učinkovito metodo kontracepcije v času zdravljenja in po zaključku zdravljenja z ribavirinom še tako dolgo, kot je opredeljeno v Povzetku glavnih značilnosti zdravila za ribavirin.
Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the treatment of CHC 
Prilagajanje odmerkov ali začasna prekinitev zdravljenja z zdravili, ki se uporabljajo v kombinaciji z zdravilom OLYSIO za zdravljenje CHC
HIV PRODUCTS Antiretroviral - CCR5 antagonist Maraviroc 
ZDRAVILA ZA ZDRAVLJENJE OKUŽBE S HIV Protiretrovirusna zdravila - antagonist CCR5 maravirok
Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Asian Hispanic 
Starost (leta) mediana (razpon) % več kot 65 let Moški Rasa belci črna rasa/afroameričani azijskega porekla latinoameričani
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 experience them. 
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.
Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease, which is essential for viral replication. 
Mehanizem delovanja Simeprevir je specifičen zaviralec serinske proteaze HCV NS3/4A, ki je bistvena za replikacijo virusov.
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 (P-gp).
Based on the elimination pathway of azithromycin, no drug interactions are expected between azithromycin and simeprevir. 
Na osnovi poti izločanja azitromicina se ne pričakuje interakcij med azitromicinom in simeprevirjem.
1 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.
Paediatric population The pharmacokinetics of simeprevir in children aged below 18 years have not been investigated. 
Farmakokinetike simeprevirja niso raziskovali pri otrocih, mlajših od 18 let.
In study C208, all patients received peginterferon alfa-2a; in study C216, 69% of the patients received peginterferon alfa-2a and 31% received peginterferon alfa-2b. 
V študiji C208 so vsi bolniki prejemali peginterferon alfa-2a; v študij C216 je 69% bolnikov prejemalo peginterferon alfa-2a in 31% peginterferon alfa-2b.
Fluconazole Voriconazole 
flukonazol vorikonazol
(inhibition of P-gp transporter) 
(zaviranje prenašalca P-gp)
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking OLYSIO. 
Če karkoli od zgoraj navedenega velja za vas (ali če o tem niste prepričani), se pred začetkom uporabe zdravila OLYSIO posvetujte z zdravnikom ali farmacevtom.
3 Overall treatment duration with peg-IFN-alfa and RBV was response-guided. 
3 Celokupno trajanje zdravljenja s peg-IFN-alfa in RBV je bilo odvisno od odziva.
1 Double-blind, randomised, placebo-controlled, except for studies C212 and HPC3011 which were open-label, single arm. 
1 Dvojno slepa, randomizirana, nadzorovana s placebom, z izjemo študij C212 in HPC3011, ki sta bili odprti študiji z eno skupino.
Antiretroviral - nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTIs) Tenofovir disoproxil fumarate 
Protiretrovirusna zdravila - nukleozidni ali nukleotidni zaviralci reverzne transkriptaze(N(t)RTI) tenofovir dizoproksil fumarat
Antiretroviral - integrase inhibitor Raltegravir 
Protiretrovirusna zdravila - zaviralec integraze raltegravir
There are no data on the effect of simeprevir on human fertility. 
O vplivu simeprevirja na plodnost pri ljudeh ni podatkov.
Do not take OLYSIO if you are allergic to simeprevir or any of the other ingredients of this medicine (listed in section 6). 
Kaj morate vedeti, preden boste vzeli zdravilo OLYSIO Ne jemljite zdravila OLYSIO, če ste alergični na simeprevir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Table 21: SVR12 rates for selected subgroups (study HPC3007) Subgroup simeprevir + peginterferon + ribavirin % (n/N) 
Preglednica 21: Stopnje SVR12 za izbrane podskupine (študija HPC3007) Podskupina simeprevir + peginterferon + ribavirin % (n/N)
Most of the rash and pruritus events in simeprevir-treated patients were of mild or moderate severity (grade 1 or 2). 
Večina primerov izpuščaja in srbenja pri bolnikih, ki so prejemali simeprevir, je bila blagih ali zmernih (stopnje 1 ali 2).
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. 
Povejte zdravniku če: - trenutno jemljete ali ste v zadnjih mesecih jemali amiodaron (če ste jamali to zdravilo, bo vaš zdravnik razmislil o drugih možnostih zdravljenja)
Organ transplant patients 
Bolniki po presaditvi organa
Discontinuation of simeprevir due to ‘blood bilirubin increased' was rare (0.1%; n = 1). 
Prekinitev zdravljenja s simeprevirjem zaradi zvečanja koncentracije bilirubina v krvi je bila redka (0,1%; n = 1).
1 The one patient with on-treatment failure discontinued treatment early due to an adverse event. 
1 En bolnik z neuspehom v času zdravljenja je zdravljenje kmalu zaključil zaradi neželenega učinka.
Treatment with OLYSIO should be initiated and monitored by a physician experienced in the management of CHC. 
Zdravljenje z zdravilom OLYSIO mora uvesti in spremljati zdravnik z izkušnjami pri zdravljenju bolnikov s CHC.
Following a single oral administration of 200 mg 14C-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). 
Po enkratnem peroralnem odmerjanju 200 mg s 14C 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).
HORMONAL CONTRACEPTIVES Ethinylestradiol and norethindrone 
HORMONSKI KONTRACEPTIVI etinilestradiol in noretindron
In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis were enrolled (table 12). 
V študijo HPC3017 so vključili bolnike brez ciroze, v študijo HPC3018 pa bolnike s cirozo (preglednica 12).
2 Relapsers after prior interferon-based therapy. 
2 Ponovitev bolezni po predhodnem zdravljenju na osnovi interferona.
Antiretroviral - protease inhibitors (PIs) Darunavir/ritonavir3 
Protiretrovirusna zdravila - zaviralci proteaze (PI) darunavir/ritonavir3
Table 21 shows the SVR rates for selected subgroups for study HPC3007. 
V preglednici 21 pa so prikazani deleži bolnikov s SVR pri izbranih podskupinah v študiji HPC3007.
In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic effects. 
In vitro je kombinacija simeprevirja z interferonom, ribavirinom, zaviralci NS5A ali NS5B delovala aditivno ali sinergistično.
Simeprevir is not a clinically relevant inhibitor of cathepsin A enzyme activity. 
Simeprevir ni klinično pomemben zaviralec encimske dejavnosti katepsina A.
The effect of simeprevir 150 mg once daily and 350 mg once daily for 7 days on the QT interval was evaluated in a randomised, double-blind, placebo- and positive-controlled (moxifloxacin 400 mg once daily), 4-way cross-over study in 60 healthy subjects. 
Vpliv 7-dnevnega odmerjanja simeprevirja v odmerku 150 mg enkrat na dan in v odmerku 350 mg enkrat na dan na interval QT so ocenjevali v randomizirani, dvojno slepi, s placebom in aktivno nadzorovani (s 400 mg moksifloksacina, enkrat na dan), štirikratno navzkrižni študiji pri 60 zdravih preiskovancih.
photosensitivity reaction* 
fotosenzitivnostna reakcija*
In the event of an overdose with OLYSIO, it is recommended to employ the usual supportive measures and observe the patient's clinical status. 
V primeru prevelikega odmerjanja zdravila OLYSIO se priporočajo splošni podporni ukrepi in spremljanje klinične slike bolnika.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/924/001 (7 capsules) 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/924/001 (7 kapsul)
1 p < 0.001 compared to historical control of peginterferon alfa and ribavirin. 
1 p < 0,001 v primerjavi z zgodovinskimi kontrolami, za uporabo peginterferona alfa in ribavirina.
Simeprevir does not inhibit OCT2 in vitro. 
Simeprevir ne zavira OCT2 in vitro.
HPC3011 (RESTORE; Phase 3) 
HPC3011 (RESTORE; faza 3)
If adverse reactions, potentially related to the medicinal products that are used in combination with OLYSIO for the treatment of CHC, require dosage adjustment or interruption of the medicinal product(s), refer to the instructions outlined in the respective Summary of Product Characteristics for these medicinal products. 
Če se pojavijo neželeni učinki, ki bi bili lahko povezani z uporabo zdravil, ki se uporabljajo v kombinaciji z zdravilom OLYSIO za zdravljenje CHC in zaradi katerih bi bilo treba prilagoditi odmerjanje ali prekiniti zdravljenje s temi zdravili, je treba upoštevati navodila v povzetku glavnih značilnosti zdravila teh zdravil.
Cases are potentially life threatening, therefore amiodarone should only be used in patients on OLYSIO combination treatment with sofosbuvir when other alternative antiarrhythmic treatments are not tolerated or are contraindicated. 
Ti pojavi so lahko življensko nevarni, zato se pri bolnikih, ki prejemajo zdravilo OLYSIO v kombinaciji sofosbuvirjem, lahko amidaron uporablja le kadar so druga antiaritmična zdravila kontraindicirana ali jih bolnik ne prenaša.
X represents multiple amino acids. 
predstavlja več aminokislin.
pruritus*, photosensitivity reaction* 
srbenje *, fotosenzitivnostna reakcija*
Contents of the pack and other information 
Shranjevanje zdravila OLYSIO Vsebina pakiranja in dodatne informacije
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 več zdravila OLYSIO, kot bi smeli, takoj obvestite zdravnika ali farmacevta.
- you have ever taken any medicines to treat hepatitis C; - you have any other liver problems in addition to hepatitis C; - you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely; - you have had or are going to have an organ transplant. 
- imate hepatitis C, ki ni ‘genotipa 1' ali ‘genotipa 4' - ste že jemali katero koli zdravilo za zdravljenje hepatitisa C - imate poleg hepatitisa C tudi druge težave z jetri - imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal
HPC3007 (PROMISE; Phase 3) 
HPC3007 (PROMISE; faza 3)
NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag International NV 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Janssen-Cilag International NV
Posology 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.
(studies HPC3007 and C206) Treatment Outcome 
(študiji HPC3007 in C206)
All HCV genotypes N = 197 % (n) 
vsi genotipi HCV N = 197 % (n)
Increased concentrations of cisapride may be possible. 
Lahko pride do zvečanja koncentracije cisaprida.
ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin 
ANTIKONVULZIVI karbamazepin okskarbazepin fenobarbital fenitoin
If you develop a photosensitivity reaction during treatment, contact your doctor immediately. 
Če se pri vas med zdravljenjem pojavi fotosenzitivna reakcija, se nemudoma obrnite na svojega zdravnika.
Effect on drug levels Least Squares Mean Ratio (90%CI) 
Vpliv na koncentracije zdravil - razmerje povprečja najmanjših kvadratov (90%IZ)
Antiviral activity in vivo 
Protivirusno delovanje in vivo
Genotype 1a1 N = 116 % (n) 
genotip 1a1 N = 116 % (n)
Co-administration of OLYSIO with substances that moderately or strongly induce or inhibit cytochrome P450 3A (CYP3A4) is not recommended as this may lead to significantly lower or higher exposure of simeprevir, respectively. 
Sočasna uporaba zdravila OLYSIO z zdravili, ki zmerno ali močno inducirajo ali zavirajo citokrom P450 3A (CYP3A4), ni priporočljiva, saj lahko bistveno zmanjša oziroma poveča izpostavljenost simeprevirju.
12, 24 or 48 weeks SMV in combination with 48 weeks peg-IFN-alfa + RBV; control group: 48 weeks placebo + peg-IFN-alfa + RBV 
12, 24 ali 48 tednov SMV v kombinaciji peg-IFN-alfa + RBV, 48 tednov; kontrolna skupina: 48 tednov placebo + peg-IFN-alfa + RBV
- 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),
2 The daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food; also refer to the Summary of Product Characteristics of ribavirin. 
2 Dnevni odmerek ribavirina temelji na telesni masi (< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg) in se daje peroralno v dveh razdeljenih odmerkih s hrano.
Recommendation for co-administration 
Priporočilo glede sočasne uporabe
Antibiotics - macrolides (systemic administration) Azithromycin 
PROTIMIKROBNA ZDRAVILA Antibiotiki - makrolidi (sistemska uporaba) azitromicin
Other NRTIs (Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Zidovudine) 
drugi nukleozidni zaviralci reverzne transkriptaze (abakavir, didanozin, emtricitabin, lamivudin, stavudin, zidovudin)
SVR12 rates for selected subgroups Prior treatment history treatment-naïve treatment-experienced4 
Stopnje SVR12 za izbrane podskupine Podatki o predhodnem zdravljenju predhodno nezdravljeni predhodno zdravljeni4
Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with OLYSIO. 
Glejte tudi povzetek glavnih značilnosti zdravila za zdravila, ki se uporabljajo v kombinaciji z zdravilom OLYSIO.
1 Open-label, randomised, except for studies HPC3018 and HPC3021 which were single arm, and study HPC2014 which was partly randomised. 
SMV = simeprevir 1 Odprte, randomizirane študije, razen študij HPC3018 in HPC3021, ki sta bili enokraki, in študije HPC2014, ki je bila delno randomizirana.
Note, substitutions at NS3 position 43 and 156 associated with reduced simeprevir activity in vitro were not observed at time of failure. 
Opozoriti velja na substituciji NS3 na položajih 43 in 156, ki sta in vitro zmanjšali aktivnost simeprevirja, pri bolnikih pa ju v času neuspeha zdravljenja niso opažali.
HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1 and 5.2). 
Sočasna okužba s HCV/virusom humane imunske pomanjkljivosti-1 (HIV-1) Pri bolnikih s sočasno okužbo s HCV/HIV-1 prilagajanje odmerkov zdravila OLYSIO ni potrebno (glejte poglavja 4.8, 5.1 in 5.2).
Medicinal products that affect simeprevir exposure 
Zdravila, na katera vpliva simeprevir
48 weeks3 
48 tednov3
- Take this medicine by mouth. 
- Zdravilo zaužijte.
4 Body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin. 
4 Odmerjanje ribavirina glede na telesno maso, dvakrat na dan, v skladu s povzetkom glavnih značilnosti zdravila za ribavirin.
Race No dose adjustment is necessary based on race (see section 5.2). 
Rasa Prilagajanje odmerkov glede na rasno pripadnost ni potrebno (glejte poglavje 5.2).