natgillin/translations-raw huggingface dataset:
(OATP1B1/3, BCRP transporter inhibition)
(zaviranje prenašalcev OATP1B1/3, BCRP)
800/100 mg once daily darunavir AUC 1.18 (1.11-1.25) ↑ darunavir Cmax 1.04 (0.99-1.10) ↔ darunavir Cmin 1.31 (1.13-1.52) ↑ ritonavir AUC 1.32 (1.25-1.40) ↑ ritonavir Cmax 1.23 (1.14-1.32) ↑ ritonavir Cmin 1.44 (1.30-1.61) ↑ simeprevir AUC 2.59 (2.15-3.11) ↑* simeprevir Cmax 1.79 (1.55-2.06) ↑* simeprevir Cmin 4.58 (3.54-5.92) ↑*
AUC darunavirja 1,18 (1,11-1,25) ↑ Cmax darunavirja 1,04 (0,99-1,10) ↔ Cmin darunavirja 1,31 (1,13-1,52) ↑ AUC ritonavirja 1,32 (1,25-1,40) ↑ Cmax ritonavirja 1,23 (1,14-1,32) ↑ Cmin ritonavirja 1,44 (1,30-1,61) ↑ AUC simeprevirja 2,59 (2,15-3,11) ↑* Cmax simeprevirja 1,79 (1,55-2,06) ↑* Cmin simeprevirja 4,58 (3,54-5,92) ↑*
Description of selected adverse reactions
Opis izbranih neželenih učinkov Izpuščaj in srbenje
Rilpivirine 25 mg once daily rilpivirine AUC 1.12 (1.05-1.19) ↔ rilpivirine Cmax 1.04 (0.95-1.13) ↔ rilpivirine Cmin 1.25 (1.16-1.35) ↑ simeprevir AUC 1.06 (0.94-1.19) ↔ simeprevir Cmax 1.10 (0.97-1.26) ↑ simeprevir Cmin 0.96 (0.83-1.11) ↔
AUC rilpivirina 1,12 (1,05-1,19) ↔ Cmax rilpivirina 1,04 (0,95-1,13) ↔ Cmin rilpivirina 1,25 (1,16-1,35) ↑ AUC simeprevirja 1,06 (0,94-1,19) ↔ Cmax simeprevirja 1,10 (0,97-1,26) ↑ Cmin simeprevirja 0,96 (0,83-1,11) ↔
Atorvastatin 40 mg atorvastatin AUC 2.12 (1.72-2.62) ↑ atorvastatin Cmax 1.70 (1.42-2.04) ↑ atorvastatin Cmin not studied 2-OH-atorvastatin AUC 2.29 (2.08-2.52) ↑ 2-OH-atorvastatin Cmax 1.98 (1.70-2.31) ↑ 2-OH-atorvastatin Cmin not studied
AUC 2-OH-atorvastatina 2,29 (2,08-2,52) ↑ Cmax 2-OH-atorvastatina 1,98 (1,70-2,31) ↑ Cmin 2-OH-atorvastatina niso preučevali
Genotype 1, treatment-naïve or treatment-experienced2, with compensated cirrhosis
genotip 1, predhodno nezdravljeni ali že zdravljeni bolniki2, s kompenzirano cirozo
It is not recommended to co-administer OLYSIO with rifabutin or rifapentine as co-administration may result in loss of therapeutic effect of OLYSIO.
OLYSIO z rifabutinom ali rifapentinom ni priporočljiva, saj lahko zmanjša terapevtski učinek zdravila OLYSIO.
600 mg once daily efavirenz AUC 0.90 (0.85-0.95) ↔ efavirenz Cmax 0.97 (0.89-1.06) ↔ efavirenz Cmin 0.87 (0.81-0.93) ↔ simeprevir AUC 0.29 (0.26-0.33) ↓ simeprevir Cmax 0.49 (0.44-0.54) ↓ simeprevir Cmin 0.09 (0.08-0.12) ↓
AUC efavirenza 0,90 (0,85-0,95) ↔ Cmax efavirenza 0,97 (0,89-1,06) ↔ Cmin efavirenza 0,87 (0,81-0,93) ↔ AUC simeprevirja 0,29 (0,26-0,33) ↓ Cmax simeprevirja 0,49 (0,44-0,54) ↓ Cmin simeprevirja 0,09 (0,08-0,12) ↓
2 Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin.
2 Vključuje bolnike s ponovitvijo bolezni, bolnike z delnim odzivom ali brez odziva na predhodno zdravljenje z interferonom (pegiliranim ali nepegiliranim), z ribavirinom ali brez ribavirina.
- carbamazepine, oxcarbazepine, phenobarbital or phenytoin to prevent seizures - astemizole or terfenadine to treat allergies - itraconazole, fluconazole, ketoconazole, posaconazole or voriconazole (when taken by mouth or given by injection) to treat fungal infections - rifabutin, rifampicin or rifapentine to treat infections like tuberculosis - amlodipine, bepridil, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine or verapamil
- kobicistat za zvečanje koncentracije nekaterih zdravil, ki se uporabljajo za zdravljenje okužbe z virusom HIV - atazanavir, darunavir, delavirdin, efavirenz, etravirin, fosamprenavir, indinavir, lopinavir, nelfinavir, nevirapin, ritonavir, sakvinavir ali tipranavir za zdravljenje okužbe z virusom HIV - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin ali simvastatin za zmanjševanje koncentracije holesterola
2 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT and with at least one follow-up HCV RNA assessment.
2 Pogostnost ponovitve bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno koncentracijo HCV RNK ob dejanskem zaključku zdravljenja in z najmanj eno meritvijo koncentracije HCV RNK v času spremljanja po zaključku zdravljenja.
Caution is warranted when this medicinal product with narrow therapeutic index is co-administered with OLYSIO via the oral route.
Pri peroralnem vnosu tega zdravila z ozkim terapevtskim indeksom in sočasni uporabi zdravila
4 Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin.
4 Vključuje bolnike s ponovitvijo bolezni, bolnike z delnim odzivom ali brez odziva na predhodno zdravljenje z interferonom (pegiliranim ali nepegiliranim), z ribavirinom ali brez ribavirina.
Genotype 1, treatment-naïve or treatment-experienced2, without cirrhosis
genotip 1, predhodno nezdravljeni ali že zdravljeni bolniki2, brez ciroze
Genotype 4, treatment-naïve or treatment-experienced2, with compensated cirrhosis or without cirrhosis
genotip 4, predhodno nezdravljeni ali že zdravljeni bolniki2, s kompenzirano cirozo ali brez ciroze
Simeprevir in combination with peginterferon alfa and ribavirin: During the first 12 weeks treatment with simeprevir, dyspnoea was reported in 11.8% of simeprevir-treated patients, compared to 7.6% in placebo-treated patients (all grades; pooled phase 3).
Dispneja Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom: Med-12 tedenskim zdravljenjem s simeprevirjem so o dispneji poročali pri 11,8% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 7,6% bolnikov, ki so prejemali placebo (vse stopnje, združeni podatki iz študij faze 3).
0.035 mg once daily/ 1 mg once daily ethinylestradiol AUC 1.12 (1.05-1.20) ↔ ethinylestradiol Cmax 1.18 (1.09-1.27) ↑ ethinylestradiol Cmin 1.00 (0.89-1.13) ↔ norethindrone AUC 1.15 (1.08-1.22) ↔ norethindrone Cmax 1.06 (0.99-1.14) ↔ norethindrone Cmin 1.24 (1.13-1.35) ↑
AUC etinilestradiola 1,12 (1,05-1,20) ↔ Cmax etinilestradiola 1,18 (1,09-1,27) ↑ Cmin etinilestradiola 1,00 (0,89-1,13) ↔ AUC noretindrona 1,15 (1,08-1,22) ↔ Cmax noretindrona 1,06 (0,99-1,14) ↔ Cmin noretindrona 1,24 (1,13-1,35) ↑
It is not recommended to co-administer OLYSIO with systemic dexamethasone as co-administration may result in loss of therapeutic effect of OLYSIO.
OLYSIO s sistemsko obliko deksametazona ni priporočljiva, saj lahko povzroči izgubo terapevtskega učinka zdravila OLYSIO.
Outcome for patients without SVR12 On-treatment failure2
Izid zdravljenja pri bolnikih brez SVR12
(OATP1B1/3 transporter inhibition)
(zaviranje prenašalca OATP1B1/3)
Chemistry
ZDRAVILA
The dosing recommendation is applicable to the recommended dose of simeprevir 150 mg once daily.
Priporočilo za odmerjanje se nanaša na priporočeni odmerek 150 mg simeprevirja enkrat na dan. 2 Primerjava s podatki zgodovinskih kontrol.
Mild increases in concentrations of these antiarrhythmics may be expected when these medicinal products are administered orally.
Pri peroralni uporabi je mogoče pričakovati blago zvečanje koncentracije navedenih antiaritmikov.
Triazolam (oral)
triazolam (peroralni) Niso preučevali.
Nizatidine
genotipe
Maximum plasma concentrations (Cmax) are typically achieved between 4 to 6 hours post dose.
Učinkovina doseže najvišjo koncentracijo v plazmi (Cmax) praviloma 4
NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules simeprevir
IME ZDRAVILA OLYSIO 150 mg trde kapsule simeprevir
or amiodarone to treat irregular heart beat - clarithromycin, erythromycin (when taken by mouth or given by injection) or telithromycin to treat bacterial infections - warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
- digoksin, dizopiramid, flekainid, meksiletin, propafenon ali kinidin (če zdravilo zaužijete) ali amiodaron za zdravljenje motenj srčnega ritma - klaritromicin, eritromicin (če zdravilo zaužijete ali ga prejmete z injekcijo) ali telitromicin za zdravljenje bakterijskih okužb
Cobicistat-containing medicinal products
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
- Keep this medicine out of the sight and reach of children.
Zdravilo shranjujte nedosegljivo otrokom!
HCV PRODUCTS Antiviral
Pri bolnikih s HCV
Treatment Outcome simeprevir + peginterferon + ribavirin N = 521 % (n/N)
Simeprevir + peginterferon alfa + ribavirin N = 521 % (n/N)
Compared to healthy subjects with normal renal function (classified using the Modification of Diet in Renal Disease [MDRD] eGFR formula; eGFR ≥ 80 ml/min), the mean steady-state AUC of simeprevir was 1.62-fold higher (90% confidence interval: 0.73-3.6) in subjects with severe renal impairment (eGFR below 30 ml/min).
(90% IZ: 0,73-3,6) kot pri zdravih osebah z normalno ledvično funkcijo (opredeljeni s formulo za ocenjeno glomerulno filtracijo po metodi Modification of Diet in Renal Disease [MDRD] kot eGFR ≥ 80 ml/min), Ker se lahko pri bolnikih z okužbo s HCV in hudo okvaro ledvic izpostavljenost poveča, je pri predpisovanju simeprevirja tem bolnikom potrebna previdnost.
2 Treatment-experienced to prior treatment with peginterferon and ribavirin.
2 predhodno zdravljeni s peginterferonom alfa in ribavirinom
Mild increases in simeprevir concentrations may occur due to mild inhibition of OATP1B1 by sildenafil.
Zaradi šibkega zaviranja OATP1B1 s sildenafilom se lahko pričakuje blago zvečanje koncentracij simeprevirja.
Hepatic impairment
- težko dihanje
(inhibition of CYP3A4 enzymes and P-gp transporter by both erythromycin and simeprevir)
(eritromicin in simeprevir zavirata CYP3A4 in prenašalec P-gp)
sofosbuvir N = 286 n (%)
12 tednov simeprevir + sofosbuvir N = 286 n (%)
Sofosbuvir2 400 mg once daily sofosbuvir AUC 3.16 (2.25-4.44) ↑ sofosbuvir Cmax 1.91 (1.26-2.90) ↑ sofosbuvir Cmin not studied GS-331007 AUC 1.09 (0.87-1.37) ↔ GS-331007 Cmax 0.69 (0.52-0.93) ↓ GS-331007 Cmin not studied simeprevir AUC 0.94 (0.67-1.33) ↔ simeprevir Cmax 0.96 (0.71-1.30) ↔ simeprevir Cmin not studied
AUC GS-331007 1,09 (0,87-1,37) ↔ Cmax GS-331007 0,69 (0,52-0,93) ↓ Cmin GS-331007 niso preučevali AUC simeprevirja 0,94 (0,67-1,33) ↔ Cmax simeprevirja 0,96 (0,71-1,30) ↔
Increased plasma concentrations of pitavastatin and pravastatin are expected.
Pričakovano je zvečanje koncentracij pitavastatina oziroma pravastatina v plazmi.
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 - your urine is darker than normal - notice swelling of your stomach area.
- opazite, da so vaša koža ali oči postali rumeni - je vaš urin temejši kot običajno
Refer to the Summary of Product Characteristics of peginterferon alfa and ribavirin for pre-treatment, on-treatment and post-treatment laboratory testing requirements including haematology, biochemistry (including hepatic enzymes and bilirubin), and pregnancy testing requirements.
Za laboratorijske preiskave, ki jih je treba opraviti pred, med ter po zaključku zdravljenja s peginterferonom alfa in ribavirinom, vključno s hematološkimi in biokemijskimi preiskavami
The overall safety profile of simeprevir is based on data from 580 HCV genotype 1 infected patients who received simeprevir in combination with sofosbuvir with or without ribavirin (pooled data from the clinical phase 2 study HPC2002 and the clinical phase 3 studies HPC3017 and HPC3018) and 1,486 HCV genotype 1 infected patients who received simeprevir (or placebo) in combination with peginterferon alfa and ribavirin (pooled data from the clinical phase 2 studies C205 and C206 and the clinical phase 3 studies C208, C216 and HPC3007).
HPC3018)) in na podatkih 1.486 bolnikov, okuženih s HCV genotipa 1, ki so prejemali simeprevir (ali placebo) v kombinaciji s peginterferonom alfa in ribavirinom (združeni podatki kliničnih študij faze 2 (študiji C205 in C206) in kliničnih študij faze 3 (študije C208, C216 in HPC3007).
No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh class A).
Pri bolnikih z blago okvaro jeter (razred A po Child-Pughu) prilagajanje odmerkov zdravila OLYSIO ni potrebno.
Ledipasvir 30 mg once daily ledipasvir AUC 1.92 (1.77-2.07) ↑ ledipasvir Cmax 1.81 (1.69-2.94) ↑ ledipasvir Cmin not studied simeprevir AUC 2.69 (2.44-2.96) ↑ simeprevir Cmax 2.61 (2.34-2.86) ↑ simeprevir Cmin not studied
ledipasvir 30 mg enkrat na dan ledipasvir AUC 1,92 (1,77-2,07) ↑ ledipasvir Cmax 1,81 (1,69-2,94) ↑
In study HPC2002, photosensitivity reactions (grouped term) was reported in 7.1% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 5.6% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
V študiji HPC2002 so o fotosenzitivnih reakcijah (skupni termin) po poročali pri 7,1% bolnikov, ki so12 tednov prejemali simeprevir in sofosbuvir brez ribavirina, v primerjavi s 5,6% bolnikov, ki so 12 tednov prejemali simeprevir s sofosbuvirjem in ribavirinom Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom: med 12-tedenskim zdravljenjem s simeprevirjem so o fotosenzitivnih reakcijah poročali pri 4,7% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 0,8% bolnikov, zdravljenih s placebom (vse stopnje, združeni podatki iz študij faze 3).
OLYSIO 150 mg hard capsules simeprevir
Navodilo za uporabo OLYSIO 150 mg trde kapsule simeprevir
Decreased plasma concentrations of simeprevir are expected.
Pričakovano je zmanjšanje koncentracije simeprevirja v plazmi.
Table 19: Treatment outcome in treatment-naïve HCV genotype 1 infected patients (pooled data studies C208 and C216)
Preglednica 22: Izid zdravljenja pri bolnikih, okuženih s HCV genotipa 1 in s sočasno okužbo s HIV-1 (študija C212)
Consult the Summary of Product Characteristics of the co-prescribed medicinal products before starting therapy with OLYSIO.
Pred uvedbo zdravljenja z zdravilom OLYSIO preberite povzetek glavnih značilnosti zdravila sočasno predpisanih zdravil.
Buprenorphine Naloxone
buprenorfin nalokson
Grade 2 and 3 adverse reactions were reported in 3.5% (n = 10) and 0.3% (n = 1) of patients, respectively, receiving 12 weeks simeprevir with sofosbuvir; no grade 4 adverse reactions were reported.
(n = 10) oziroma pri 0,3% (n = 1) bolnikov, ki so 12 tednov prejemali simeprevir in sofosbuvir.
Baseline HCV RNA levels > 800,000 IU/ml
Mediane izhodiščne koncentracije HCV RNA (log10
1 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment.
1 Pogostnost ponovitve bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno koncentracijo HCV RNK ob dejanskem zaključku zdravljenja in z najmanj eno meritvijo koncentracije HCV RNK v času spremljanja po zaključku zdravljenja.
had non-CC IL28B alleles (CT or TT); 33% were treatment-naïve, and 68% were treatment-experienced.
genotipa 1b, 86% jih je imelo ne- CC IL28B alele (CT ali TT), 76% bolnikov se ni odzvalo na predhodno zdravljenje s peginterferonom alfa in ribavirinom in 24% jih še ni prejemalo zdravljenja.
Genotype 1, treatment-naïve or null responders3, with compensated cirrhosis or without cirrhosis
genotip 1, predhodno nezdravljeni bolniki ali bolniki brez odziva3, s kompenzirano cirozo ali brez ciroze
Bepridil
Izpuščaj
Ranitidine
Dojenje
* Skin rash may affect more than 1 in 10 people (very common) when OLYSIO is used in combination with sofosbuvir for 24 weeks.
- zvečana koncentracija bilirubina v krvi (bilirubin je barvilo, ki nastaja v jetrih) * Kadar se zdravilo OLYSIO v kombinaciji s sofosbuvirjem jemlje 24 tednov, se kožni izpuščaj lahko pojavi pri več kot 1 od 10 bolnikov (zelo pogosto).
No meaningful changes in QTc interval were observed with either the recommended dose of 150 mg once daily or the supratherapeutic dose of 350 mg once daily.
150 mg enkrat na dan niti pri supraterapevtskem odmerku 350 mg enkrat na dan. Pediatrična populacija
OLYSIO in combination with peginterferon alfa and ribavirin: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients, except for co-infected patients with cirrhosis who should receive 36 weeks of treatment with peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment duration of 48 weeks).
Uporaba zdravila OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom: bolnike s sočasno okužbo s HCV/HIV-1 je treba zdraviti enako dolgo kot bolnike, ki so okuženi samo s HCV, razen v primeru bolnikov s sočasno okužbo z obema virusoma in s cirozo: ti bolniki naj po zaključenem
Q80R3
D168E D168V Q80R3
Genotype 4, treatment-naïve or treatment-experienced2, with compensated cirrhosis or without cirrhosis patients without cirrhosis: 8 or 12 weeks SMV + sofosbuvir; patients with cirrhosis:
Bolniki brez ciroze: 8 ali 12 tednov SMV + sofosbuvir; Bolniki s cirozo: 12 tednov SMV + sofosbuvir
Rifampicin1 600 mg once daily rifampicin AUC 1.00 (0.93-1.08) ↔ rifampicin Cmax 0.92 (0.80-1.07) ↔ rifampicin Cmin not studied 25-desacetyl-rifampicin AUC 1.24 (1.13-1.36) ↑ 25-desacetyl-rifampicin Cmax 1.08 (0.98-1.19) ↔ 25-desacetyl-rifampicin Cmin not studied simeprevir AUC 0.52 (0.41-0.67) ↓ simeprevir Cmax 1.31 (1.03-1.66) ↑ simeprevir Cmin 0.08 (0.06-0.11) ↓
AUC rifampicina 1,00 (0,93-1,08) ↔ Cmax rifampicina 0,92 (0,80-1,07) ↔ Cmin rifampicina niso preučevali AUC 25-dezacetil-rifampicina 1,24 (1,13-1,36)
Co-administration of OLYSIO with ciclosporin is not recommended as this leads to significantly higher exposure of simeprevir based on interim data from an ongoing phase 2 study in HCV infected post-liver transplant patients (see section 4.5).
Na osnovi vmesnih podatkov še potekajoče študije faze 2 pri bolnikih po presaditvi jeter, okuženih s HCV (glejte poglavje 4.5), sočasna uporaba zdravila OLYSIO s ciklosporinom ni priporočljiva, ker pomembno zveča izpostavljenost simeprevirju.
(mild to moderate CYP3A4 enzyme inhibition)
(šibko do zmerno zaviranje CYP3A4)
(moderate CYP3A4 enzyme induction)
(zmerna indukcija CYP3A4)
Significantly increased plasma concentrations of simeprevir are expected.
Pričakuje se pomembno zvečanje koncentracije simeprevirja v plazmi.
Genotype 1, prior relapsers2, with compensated cirrhosis or without cirrhosis
genotip 1, bolniki s ponovitvijo bolezni2, s kompenzirano cirozo ali brez ciroze
In HCV genotype 1a infected patients without cirrhosis, simeprevir efficacy in combination with sofosbuvir at the recommended 12-week treatment duration was not impacted by the presence of the NS3 Q80K polymorphism (see section 5.1).
Prisotnost polimorfizma NS3 Q80K (glejte poglavje 5.1), pri bolnikih s HCV genotipa 1 brez ciroze ni vplivala na učinkovitost simeprevirja v kombinaciji s sofosbuvirjem med priporočenim 12-tedenskem zdravljenjem.
METAVIR fibrosis score
Stopnja fibroze po klasifikaciji METAVIR F0-2
3 The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Medsebojno delovanje med simeprevirjem in tem zdravilom so ocenjevali v farmakokinetični podštudiji v okviru študije faze 2 pri 22 bolnikih, okuženih s HCV. 3 V tej interakcijski študiji so 50 mg simeprevirja v kombinaciji z darunavirjem oziroma ritonavirjem primerjali s 150 mg simeprevirja samostojno.
The 167 enrolled patients had a median age of 57 years (range 27 to 70 years; with 5% above 65 years); 64% were male; 81% were White, 19% Black or African American, and 21% Hispanic; 37% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.7 log10 IU/ml;
64% je bilo moških, 81% belcev, 19% črne rase ali afroameričanov in 21% latinskoameriške etnične skupine; 37% jih je imelo ITM ≥ 30 kg/m2; mediana izhodiščne koncentracije HCV RNK je bila 6,7 log10 i.e./ml; 75% ni imelo ciroze (ocena fibroze po klasifikaciji METAVIR F0-3), 25% jih je imelo cirozo (ocena fibroze po klasifikaciji METAVIR F4); 78% je bilo okuženih s HCV genotipa 1a,
Increased simeprevir concentrations may occur due to inhibition of OATP1B1 by atorvastatin.
Zaradi zaviranja OATP1B1 z atorvastatinom se lahko pričakuje zvečanje koncentracij simeprevirja.
nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol levels - ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant failures - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
- sildenafil ali tadalafil za zdravljenje pljučne arterijske hipertenzije - midazolam ali triazolam (če ju zaužijete) za zdravljenje nespečnosti ali za lajšanje tesnobe
Outcome for patients without SVR12 On-treatment failure Viral relapse1
Rezultati zdravljenja pri bolnikih, ki niso dosegli SVR12 neuspeh v času zdravljenja ponovitev bolezni2 brez podatkov o SVR125
Mild increases in simeprevir concentrations may occur due to inhibition of CYP3A4 by amiodarone.
Zaradi zaviranja CYP3A4 z amiodaronom lahko pride do blagega zvečanja koncentracij simeprevirja v plazmi.
tacrolimus AUC 0.83 (0.59-1.16) ↓ tacrolimus Cmax 0.76 (0.65-0.90) ↓ tacrolimus Cmin not studied simeprevir AUC 1.85 (1.18-2.91) ↑6 simeprevir Cmax 1.79 (1.22-2.62) ↑6 simeprevir Cmin not studied6
AUC simeprevirja 1,85 (1,18-2,91) ↑6 Cmax simeprevirja 1,79 (1,22-2,62) ↑6
Outcome for patients without SVR12 On-treatment failure Viral relapse2
SVR12 Izid zdravljenja pri bolnikih brez SVR12
Table 22: Treatment outcome in HCV genotype 1 infected patients with HIV-1 co-infection
Preglednica 19: Izid zdravljenja pri predhodno nezdravljenih bolnikih, okuženih s HCV
1 In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 4.4).
HCV genotipa 1a razmislite o testiranju na prisotnost polimorfizma Q80K (glejte poglavje 4.4).
3 Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable)
3 Pogostnost ponovitve bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno (ali nepotrjeno zaznavno) koncentracijo HCV RNK ob dejanskem zaključku zdravljenja.
The following side effects may happen with OLYSIO when used in combination with peginterferon alfa and ribavirin:
Pri jemanju zdravila OLYSIO skupaj s peginterferonom alfa in ribavirinom se lahko pojavijo naslednji neželeni učinki:
Increased plasma concentrations of simeprevir are expected.
Pričakovano je zvečanje koncentracije simeprevirja v plazmi.
- digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth)
- itrakonazol, flukonazol, ketokonazol, posakonazol ali vorikonazol (če zdravilo zaužijete ali ga prejmete z injekcijo) za zdravljenje glivičnih okužb
It is not recommended to co-administer OLYSIO with darunavir/ritonavir.
OLYSIO z darunavirjem oziroma ritonavirjem ni priporočljiva.
The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people: - itching of the skin - skin rash* - constipation - being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver).
Pri jemanju zdravila OLYSIO skupaj s sofosbuvirjem se lahko pojavijo naslednji neželeni učinki: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov: - srbenje kože
The company wanted the authorisation to be recognised in Belgium, Germany, Italy, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Družba je želela, da se dovoljenje za promet z zdravilom prizna v Belgiji, Nemčiji, Italiji, Španiji, na Švedskem in v Združenem kraljestvu (zadevne države članice).
The review was carried out under an ‘Article 29' referral1.
Pregled je bil izveden v skladu z napotitvenim postopkom1 iz člena 29.
Dr Robert James Hemmings
dr. Robert James Hemmings dr. Tomas Salmonson
Questions and answers on the referral for Ciclosporin IDL and associated names capsules containing ciclosporin 25 mg, 50 mg and 100 mg
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Ciclosporin IDL in povezana imena kapsule, ki vsebujejo ciklosporin v odmerku 25 mg, 50 mg in 100 mg