natgillin/translations-raw huggingface dataset:
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).
Compared to healthy subjects with normal hepatic function, the mean steady-state AUC of simeprevir was 2.4-fold higher in non-HCV infected subjects with moderate hepatic impairment (Child-Pugh class B) and 5.2-fold higher in non-HCV infected subjects with severe hepatic impairment (Child-Pugh class C).
V primerjavi z zdravimi osebami z normalnim delovanjem jeter je bila povprečna vrednost AUC simeprevirja v stanju dinamičnega ravnovesja 2,4-krat večja pri osebah brez okužbe s HCV, ki so imele zmerno okvaro jeter (razreda B po Child-Pughu), in 5,2-krat večja pri osebah brez okužbe s HCV in s hudo okvaro jeter (razreda C po Child-Pughu).
Simeprevir is highly protein bound, therefore dialysis is unlikely to result in significant removal of simeprevir (see section 5.2).
Simeprevir se obsežno veže na beljakovine, zato ga z dializo po vsej verjetnosti ni mogoče v večji meri odstraniti iz telesa (glejte poglavje 5.2).
Disopyramide Flecainide Mexiletine Propafenone Quinidine
dizopiramid flekainid meksiletin propafenon kinidin
SVR12 rates for selected subgroups METAVIR fibrosis score F0-2
Stopnje SVR za izbrane podskupine Stopnja fibroze po klasifikaciji METAVIR F0-2
The median baseline CD4+ cell count in patients on highly active antiretroviral therapy (HAART) was 561 x 106 cells/ml (range: 275-1,407 x 106 cells/ml).
Pri bolnikih, ki so prejemali visoko aktivno protiretrovirusno zdravljenje (HAART, highly active antiretroviral therapy), je bilo ob izhodišču mediano število celic CD4+ 561 x 106 celic/ml (od 275 do 1.407 x 106 celic/ml).
with cirrhosis, who are co-infected with HIV
s cirozo, ki so okuženi tudi s HIV
- If you are a man, your female partner must not become pregnant during your treatment and for several months afterwards.
- Če ste moški, vaša partnerka ne sme zanositi v času, ko vi jemljete zdravila in še nekaj mesecev po zaključku zdravljenja z njimi.
There were no adverse effects of simeprevir on vital functions (cardiac, respiratory and central nervous system) in animal studies.
V študijah na živalih simeprevir ni izkazoval neželenega delovanja na vitalne funkcije (na delovanje srca, dihal in centralnega živčevja).
If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the reaction has resolved.
Če se pojavijo fotosenzitivnostne reakcije, je treba razmisliti o prenehanju uporabe zdravila OLYSIO, bolnika pa spremljati do izboljšanja.
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
2 Following prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin (see section 5.1).
2 Po predhodnem zdravljenju z interferonom (pegiliranim ali nepegiliranim), skupaj z ribavirinom ali brez ribavirina (glejte poglavje 5.1).
Respiratory, thoracic and mediastinal disorders: very common dyspnoea*
Bolezni dihal, prsnega koša in mediastinalnega prostora: zelo pogosti dispneja*
Discontinuation of simeprevir due to rash or pruritus occurred in 0.8% and 0.1% of simeprevir-treated patients, compared to 0.3% and 0% of placebo-treated patients, respectively.
Do prekinitve zdravljenja s simeprevirjem zaradi izpuščaja ali srbenja je prišlo pri 0,8% in 0,1% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 0,3% in 0% bolnikov, ki so prejemali placebo.
Mild increases in concentrations of triazolam may be expected.
Pričakovati je mogoče blago zvečanje koncentracije triazolama.
Other ritonavir-boosted or unboosted HIV PIs (Atazanavir, (Fos)amprenavir, Lopinavir, Indinavir, Nelfinavir, Saquinavir, Tipranavir)
drugi zaviralci proteaz, okrepljeni z ritonavirjem ali ne (atazanavir, amprenavir, fosamprenavir, lopinavir, indinavir, nelfinavir, sakvinavir, tipranavir)
treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12.
Načrtovano skupno trajanje zdravljenja HCV je bilo 24 tednov, če so bili doseženi naslednji od odziva odvisni in v protokolu določeni kriteriji: zaznavna koncentracija HCV RNK < 25 i.e./ml ali nezaznavna po 4. tednu IN nezaznavna koncentracija HCV RNK po 12. tednu.
GLUCOCORTICOIDS Dexamethasone (systemic)
GLUKOKORTIKOIDI deksametazon (sistemski)
During the first 12 weeks of treatment, the most frequently reported adverse reactions (incidence ≥ 5%) were nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction (see section 4.4).
V prvih 12 tednih zdravljenja so najpogosteje (pri ≥ 5%) poročali o naslednjih neželenih učinkih: navzea, izpuščaj, srbenje, dispneja, zvečanje koncentracije bilirubina v krvi in fotosenzitivnostna reakcija (glejte poglavje 4.4).
1 May include few patients with HCV non-genotype 1a/1b.
Lahko vključuje nekaj bolnikov z virusom hepatitisa C, ki niso genotipa 1a ali 1b.
As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Simeprevir se v veliki meri veže na beljakovine v plazmi, zato ga z dializo po vsej verjetnosti ni mogoče v večji meri odstraniti iz telesa.
- Swallow the capsule whole.
- Kapsulo morate pogoltniti celo.
HERBAL PRODUCTS Milk thistle (Silybum marianum)
ZDRAVILA RASTLINSKEGA IZVORA pegasti badelj (Silybum marianum)
1 Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin).
1 Superioren v primerjavi s predhodnimi kontrolami (predhodne stopnje SVR odobrene kombinacije zdravljenja z direktnim delovanjem na viruse s peginterferonom alfa in ribavirinom).
OLYSIO contains lactose
Zdravilo OLYSIO vsebuje laktozo
PHOSPHODIESTERASE TYPE 5 INHIBITORS Sildenafil
ZAVIRALCI FOSFODIESTERAZE TIPA 5 sildenafil tadalafil vardenafil
Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and summary of study design
Preglednica 17: Študije, izvedene s kombinacijo simeprevir + peginterferon alfa + ribavirin: populacija in povzetek načrta študij
As exposure may be increased in HCV infected patients with severe renal impairment, caution is recommended when prescribing OLYSIO to these patients (see section 5.2).
Izpostavljenost se lahko poveča pri bolnikih, okuženih s HCV in s hudo okvaro jeter, zato je pri predpisovanju zdravila OLYSIO tem bolnikom priporočljiva previdnost (glejte poglavje 5.2).
Capsule content Sodium lauryl sulfate Magnesium stearate Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate
Vsebina kapsule natrijev lavrilsulfat magnezijev stearat koloidni brezvodni silicijev dioksid premreženi natrijev karmelozat laktoza monohidrat
Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Preglednica 11: Študije s simeprevirjem in sofosbuvirjem: populacija in povzetek načrta študij
Interim data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Vmesna analiza podatkov iz študije faze 2 pri 11 bolnikih s presaditvijo jeter, okuženih s HCV.
In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated patients (all grades; pooled phase 3).
Pri bolnikih, starih > 45 let, so o dispneji poročali pri 16,4% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 9,1% bolnikov, ki so prejemali placebo (vse stopnje, združeni podatki iz študij faze 3).
If a dose of OLYSIO is missed by more than 12 hours after the usual dosing time, the patient should not take the missed dose of OLYSIO and should resume dosing of OLYSIO with food at the regularly scheduled time.
Če se bolnik na pozabljeni odmerek zdravila OLYSIO spomni po več kot 12 urah od običajnega časa odmerjanja, naj ne vzame pozabljenega odmerka zdravila OLYSIO, ampak naj nadaljuje z odmerjanjem zdravila OLYSIO skupaj s hrano po običajnem razporedu.
Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Genotype
Preglednica 9: Protivirusno delovanje 200 mg simeprevirja v monoterapiji (študiji C201 in C202)
How to take OLYSIO
Kako jemati zdravilo OLYSIO
R(-) methadone AUC 0.99 (0.91-1.09) ↔ R(-) methadone Cmax 1.03 (0.97-1.09) ↔ R(-) methadone Cmin 1.02 (0.93-1.12) ↔
AUC R(-) metadona 0,99 (0,91-1,09) ↔ Cmax R(-) metadona 1,03 (0,97-1,09) ↔ Cmin R(-) metadona 1,02 (0,93-1,12) ↔
IL28B genotype
F4 genotip IL28B
Patients co-infected with HIV-1
Bolniki s sočasno okužbo s HIV-1