FrancophonIA/ELRC3.0 huggingface dataset:
English: In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the NS3 Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 5.1).
Slovenian: Pri bolnikih s cirozo, okuženih s HCV genotipa 1a, se lahko pred uvedbo zdravljenja z zdravilom OLYSIO v kombinaciji s sofosbuvirjem razmisli o testiranju na prisotnost polimorfizma NS3 Q80K (glejte poglavje 5.1).
English: Hepatic decompensation and hepatic failure, including fatal cases, have been reported post-marketing in patients treated with OLYSIO in combination with peginterferon alfa and ribavirin and in combination with sofosbuvir.
Slovenian: Dekompenzacija in odpoved jeter V obdobju trženja zdravila so pri bolnikih, ki so zdravilo OLYSIO prejemali v kombinaciji s peginterferonom alfa in ribavirinom ali v kombinaciji s sofosbuvirjem, poročali o dekompenzaciji in odpovedi jeter, vključno s smrtnimi primeri.
English: 1 HCV/HIV-1 co-infected patients.
Slovenian: 1 bolniki s sočasno okužbo s HCV/HIV-1
English: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.2 and 4.4).
Slovenian: Uporaba zdravila OLYSIO pri bolnikih z zmerno ali hudo okvaro jeter ni priporočljiva (razreda B ali C po Child-Pughu) (glejte poglavji 4.2 in 4.4).
English: D168V
Slovenian: R155K
English: Median baseline HCV RNA levels (log10 IU/ml) Presence of cirrhosis no cirrhosis with cirrhosis Prior treatment history treatment-naïve treatment-experienced1 IL28B genotype CC non-CC HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a HCV genotype 1a with Q80K HCV genotype 1b
Slovenian: i.e./ml) Prisotnost ciroze brez ciroze s cirozo Podatki o predhodnem zdravljenju predhodno nezdravljeni predhodno zdravljeni1 genotip IL28B CC ne-CC HCV geno/podtip in prisotnost polimorfizma Q80K ob izhodišču pri HCV genotipa 1a HCV genotip 1a s Q80K HCV genotip 1b
English: Budesonide Fluticasone Methylprednisolone Prednisone
Slovenian: budezonid flutikazon metilprednizolon prednizon
English: Each capsule contains simeprevir sodium equivalent to 150 milligrams of simeprevir.
Slovenian: Ena kapsula vsebuje natrijev simeprevir v količini, ki ustreza 150 mg simeprevirja.
English: > 1.5 to ≤ 2.5 x ULN
Slovenian: > 1,5 do ≤ 2,5 x ZMN
English: Serious adverse reactions were reported in 0.3% of simeprevir-treated patients (2 photosensitivity events requiring hospitalisation) and in none of the patients receiving placebo with peginterferon alfa and ribavirin.
Slovenian: (2 fotosenzitivnostna dogodka, ki sta zahtevala hospitalizacijo), in pri nobenem od tistih, ki so prejemali placebo skupaj s peginterferonom alfa in z ribavirinom.
English: (OATP1B1/3 transporter and/or CYP3A4 enzyme inhibition)
Slovenian: (zaviranje prenašalca OATP1B1/3 in/ali CYP3A4)
English: Table 20: Treatment outcome in treatment-experienced1 HCV genotype 1 infected patients
Slovenian: Preglednica 20: Izidi zdravljenja pri že zdravljenih bolnikih1, okuženih s HCV genotipa 1
English: 2 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT.
Slovenian: 2 Pogostnost ponovitve bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno koncentracijo HCV RNK ob dejanskem zaključku zdravljenja.
English: (OATP1B1 transporter and/or CYP3A4 enzyme inhibition)
Slovenian: (zaviranje prenašalca OATP1B1 in/ali CYP3A4)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje natrijev simeprevir v količini, ki ustreza 150 mg simeprevirja.
English: The impact of prior exposure to simeprevir in patients not achieving SVR on the efficacy of subsequent HCV NS3/4A PI-based treatment regimens has not been established.
Slovenian: Vpliva predhodne izpostavljenosti simeprevirju na učinkovitost nadaljnjega zdravljenja z zaviralci proteaze HCV NS3/4A pri bolnikih, ki niso dosegli
English: Erythromycin 500 mg three times a day erythromycin AUC 1.90 (1.53-2.36) ↑ erythromycin Cmax 1.59 (1.23-2.05) ↑ erythromycin Cmin 3.08 (2.54-3.73) ↑ simeprevir AUC 7.47 (6.41-8.70) ↑ simeprevir Cmax 4.53 (3.91-5.25) ↑ simeprevir Cmin 12.74 (10.19-15.93) ↑
Slovenian: AUC eritromicina 1,90 (1,53-2,36) ↑ Cmax eritromicina 1,59 (1,23-2,05) ↑ Cmin eritromicina 3,08 (2,54-3,73) ↑ AUC simeprevirja 7,47 (6,41-8,70) ↑ Cmax simeprevirja 4,53 (3,91-5,25) ↑ Cmin simeprevirja 12,74 (10,19-15,93) ↑
English: Altered plasma concentrations of simeprevir are expected.
Slovenian: Pričakovana je sprememba koncentracije simeprevirja v plazmi.
English: This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite - confusion.
Slovenian: - siljenje na bruhanje (nauzea), bruhanje ali izguba apetita - zmedenost.
English: In these patients the SVR12 rates were 96%, 94%, 100% and 68%, respectively.
Slovenian: Pri teh bolnikih je bila stopnja SVR12 94%.
English: 1 Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin, and interferon-intolerant patients.
Slovenian: 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, in bolnike, ki ne prenešajo interferona.
English: In a biochemical assay, simeprevir inhibited the proteolytic activity of recombinant genotype 1a and 1b HCV NS3/4A proteases, with median Ki values of 0.5 nM and 1.4 nM, respectively.
Slovenian: HCV NS3/4A genotipa 1a in 1b z medianima vrednostima inhibicijske konstante Ki 0,5 nM in 1,4 nM.
English: (when taken by mouth) to decrease blood pressure - dexamethasone (when given by injection or taken by mouth) to treat asthma or inflammation and auto-immune diseases - cisapride to treat stomach problems - milk thistle (a herbal medicine) for liver problems - St John's wort (Hypericum perforatum, a herbal medicine) for anxiety or depression - ledipasvir to treat hepatitis C infection - cobicistat to increase levels of some medicines used to treat HIV infection - atazanavir, darunavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir,
Slovenian: zdravljenje vnetnih ali avtoimunskih bolezni - cisaprid za zdravljenje težav z želodcem - pegasti badelj (zdravilo rastlinskega izvora) za zdravljenje težav z jetri - šentjanževka (Hypericum perforatum, zdravilo rastlinskega izvora) za zdravljenje tesnobe in depresije - ledipasvir za zdravljenje okužbe z virusom hepatitisa C
English: It is not recommended to co-administer OLYSIO with ciclosporin.
Slovenian: OLYSIO in ciklosporinov ni priporočljiva.
English: HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a HCV genotype 1a with Q80K
Slovenian: HCV geno/podtip in prisotnost polimorfizma Q80K ob izhodišču pri HCV genotipa 1 HCV genotipa 1a s Q80K
English: 300 mg once daily tenofovir AUC 1.18 (1.13-1.24) ↔ tenofovir Cmax 1.19 (1.10-1.30) ↑ tenofovir Cmin 1.24 (1.15-1.33) ↑ simeprevir AUC 0.86 (0.76-0.98) ↓ simeprevir Cmax 0.85 (0.73-0.99) ↓ simeprevir Cmin 0.93 (0.78-1.11) ↓
Slovenian: AUC tenofovirja 1,18 (1,13-1,24) ↔ Cmax tenofovirja 1,19 (1,10-1,30) ↑ Cmin tenofovirja 1,24 (1,15-1,33) ↑ AUC simeprevirja 0,86 (0,76-0,98) ↓ Cmax simeprevirja 0,85 (0,73-0,99) ↓ Cmin simeprevirja 0,93 (0,78-1,11) ↓
English: (strong CYP3A4 induction)
Slovenian: (močna indukcija CYP3A4)
English: 400 mg twice a day raltegravir AUC 1.08 (0.85-1.38) ↑ raltegravir Cmax 1.03 (0.78-1.36) ↔ raltegravir Cmin 1.14 (0.97-1.36) ↑ simeprevir AUC 0.89 (0.81-0.98) ↔ simeprevir Cmax 0.93 (0.85-1.02) ↔ simeprevir Cmin 0.86 (0.75-0.98) ↓
Slovenian: AUC raltegravirja 1,08 (0,85-1,38) ↑ Cmax raltegravirja 1,03 (0,78-1,36) ↔ Cmin raltegravirja 1,14 (0,97-1,36) ↑ AUC simeprevirja 0,89 (0,81-0,98) ↔ Cmax simeprevirja 0,93 (0,85-1,02) ↔ Cmin simeprevirja 0,86 (0,75-0,98) ↓
English: Table 16: Treatment outcome in HCV genotype 4 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC2014 and HPC3021) Treatment outcome
Slovenian: Preglednica 16: Izid zdravljenja pri bolnikih, okuženih s HCV genotipa 4, ki so 12 tednov prejemali simeprevir + sofosbuvir (študiji HPC2014 in HPC3021) Izid zdravljenja študija HPC2014 N = 43 % (n/N)
English: Genotype 1, treatment-naïve patients, with compensated cirrhosis or without cirrhosis
Slovenian: genotip 1, nezdravljeni bolniki s kompenzirano cirozo ali brez ciroze
English: Patients had compensated liver disease (including cirrhosis), HCV RNA of at least 10,000 IU/ml, and liver histopathology consistent with CHC (if available).
Slovenian: 10.000 i.e./ml in histopatološki izvid jetrne biopsije skladen z diagnozo kroničnega hepatitisa C (če je bil na voljo).
English: 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 BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.01 log10 IU/ml; 37% had cirrhosis; 30% had HCV genotype 4a, and 56% HCV genotype 4c or 4d; 79% had non-CC IL28B alleles (CT or TT); 52% were treatment-naïve, and 48% were treatment-experienced.
Slovenian: je imelo ITM ≥ 30 kg/m2; mediana izhodiščne koncentracije HCV RNK je bila 6,01 log10 i.e./ml; 37% jih je imelo cirozo; 30% je bilo okuženih s HCV genotipa 4a, in 56% okužbo s HCV genotipa 4c ali 4d; 79% jih je imelo ne-CC IL28B alele (CT ali TT); 52% bolnikov še ni bilo zdravljenih, in 48% bolnikov je že bilo zdravljenih.
English: Daclatasvir 60 mg once daily daclatasvir AUC 1.96 (1.84-2.10) ↑ daclatasvir Cmax 1.50 (1.39-1.62) ↑ daclatasvir Cmin 2.68 (2.42-2.98) ↑ simeprevir AUC 1.44 (1.32-1.56) ↑ simeprevir Cmax 1.39 (1.27-1.52) ↑ simeprevir Cmin 1.49 (1.33-1.67) ↑
Slovenian: AUC daklatasvirja 1,96 (1,84-2,10) ↑ Cmax daklatasvirja 1,50 (1,39-1,62) ↑ Cmin daklatasvirja 2,68 (2,42-2,98) ↑ AUC simeprevirja 1,44 (1,32-1,56) ↑ Cmax simeprevirja 1,39 (1,27-1,52) ↑ Cmin simeprevirja 1,49 (1,33-1,67) ↑
English: OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.4 and 5.2).
Slovenian: Uporaba zdravila OLYSIO pri bolnikih z zmerno do hudo okvaro jeter ni priporočljiva (razreda B ali C po Child-Pughu) (glejte poglavji 4.4 in 5.2).
English: ANTIDEPRESSANTS Escitalopram 10 mg once daily escitalopram AUC 1.00 (0.97-1.03) ↔ escitalopram Cmax 1.03 (0.99-1.07) ↔ escitalopram Cmin 1.00 (0.95-1.05) ↔ simeprevir AUC 0.75 (0.68-0.83) ↓ simeprevir Cmax 0.80 (0.71-0.89) ↓ simeprevir Cmin 0.68 (0.59-0.79) ↓
Slovenian: AUC escitaloprama 1,00 (0,97-1,03) ↔ Cmax escitaloprama 1,03 (0,99-1,07) ↔ Cmin escitaloprama 1,00 (0,95-1,05) ↔ AUC simeprevirja 0,75 (0,68-0,83) ↓ Cmax simeprevirja 0,80 (0,71-0,89) ↓ Cmin simeprevirja 0,68 (0,59-0,79) ↓
English: Prior treatment history treatment-naïve treatment-experienced2
Slovenian: Podatki o predhodnem zdravljenju predhodno nezdravljeni predhodno zdravljeni2
English: HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a Genotype 1a with Q80K without Q80K Genotype 1b
Slovenian: HCV geno/podtip in prisotnost polimorfizma Q80K ob izhodišču pri HCV genotipa 1a genotip 1a s Q80K brez Q80K genotip 1b
English: SOC
Slovenian: SZO1
English: (OATP1B1/3, BCRP transporter inhibition)
Slovenian: (zaviranje prenašalcev OATP1B1/3, BCRP)
English: 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) ↑*
Slovenian: 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) ↑*
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Izpuščaj in srbenje
English: 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) ↔
Slovenian: 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) ↔
English: 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
Slovenian: 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
English: Genotype 1, treatment-naïve or treatment-experienced2, with compensated cirrhosis
Slovenian: genotip 1, predhodno nezdravljeni ali že zdravljeni bolniki2, s kompenzirano cirozo
English: It is not recommended to co-administer OLYSIO with rifabutin or rifapentine as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovenian: OLYSIO z rifabutinom ali rifapentinom ni priporočljiva, saj lahko zmanjša terapevtski učinek zdravila OLYSIO.
English: 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) ↓
Slovenian: 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) ↓
English: 2 Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin.
Slovenian: 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.
English: - 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
Slovenian: - 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
English: 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.
Slovenian: 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.
English: Caution is warranted when this medicinal product with narrow therapeutic index is co-administered with OLYSIO via the oral route.
Slovenian: Pri peroralnem vnosu tega zdravila z ozkim terapevtskim indeksom in sočasni uporabi zdravila
English: 4 Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin.
Slovenian: 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.
English: Genotype 1, treatment-naïve or treatment-experienced2, without cirrhosis
Slovenian: genotip 1, predhodno nezdravljeni ali že zdravljeni bolniki2, brez ciroze
English: Genotype 4, treatment-naïve or treatment-experienced2, with compensated cirrhosis or without cirrhosis
Slovenian: genotip 4, predhodno nezdravljeni ali že zdravljeni bolniki2, s kompenzirano cirozo ali brez ciroze
English: 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).
Slovenian: 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).
English: 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) ↑
Slovenian: 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) ↑
English: It is not recommended to co-administer OLYSIO with systemic dexamethasone as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovenian: OLYSIO s sistemsko obliko deksametazona ni priporočljiva, saj lahko povzroči izgubo terapevtskega učinka zdravila OLYSIO.
English: Outcome for patients without SVR12 On-treatment failure2
Slovenian: Izid zdravljenja pri bolnikih brez SVR12
English: (OATP1B1/3 transporter inhibition)
Slovenian: (zaviranje prenašalca OATP1B1/3)
English: Chemistry
Slovenian: ZDRAVILA
English: The dosing recommendation is applicable to the recommended dose of simeprevir 150 mg once daily.
Slovenian: Priporočilo za odmerjanje se nanaša na priporočeni odmerek 150 mg simeprevirja enkrat na dan. 2 Primerjava s podatki zgodovinskih kontrol.
English: Mild increases in concentrations of these antiarrhythmics may be expected when these medicinal products are administered orally.
Slovenian: Pri peroralni uporabi je mogoče pričakovati blago zvečanje koncentracije navedenih antiaritmikov.
English: Triazolam (oral)
Slovenian: triazolam (peroralni) Niso preučevali.
English: Nizatidine
Slovenian: genotipe
English: Maximum plasma concentrations (Cmax) are typically achieved between 4 to 6 hours post dose.
Slovenian: Učinkovina doseže najvišjo koncentracijo v plazmi (Cmax) praviloma 4
English: NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules simeprevir
Slovenian: IME ZDRAVILA OLYSIO 150 mg trde kapsule simeprevir
English: 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.
Slovenian: - 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
English: Cobicistat-containing medicinal products
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: - Keep this medicine out of the sight and reach of children.
Slovenian: Zdravilo shranjujte nedosegljivo otrokom!
English: HCV PRODUCTS Antiviral
Slovenian: Pri bolnikih s HCV
English: Treatment Outcome simeprevir + peginterferon + ribavirin N = 521 % (n/N)
Slovenian: Simeprevir + peginterferon alfa + ribavirin N = 521 % (n/N)
English: 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).
Slovenian: (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.
English: 2 Treatment-experienced to prior treatment with peginterferon and ribavirin.
Slovenian: 2 predhodno zdravljeni s peginterferonom alfa in ribavirinom
English: Mild increases in simeprevir concentrations may occur due to mild inhibition of OATP1B1 by sildenafil.
Slovenian: Zaradi šibkega zaviranja OATP1B1 s sildenafilom se lahko pričakuje blago zvečanje koncentracij simeprevirja.
English: Hepatic impairment
Slovenian: - težko dihanje
English: (inhibition of CYP3A4 enzymes and P-gp transporter by both erythromycin and simeprevir)
Slovenian: (eritromicin in simeprevir zavirata CYP3A4 in prenašalec P-gp)
English: sofosbuvir N = 286 n (%)
Slovenian: 12 tednov simeprevir + sofosbuvir N = 286 n (%)
English: 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
Slovenian: 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) ↔
English: Increased plasma concentrations of pitavastatin and pravastatin are expected.
Slovenian: Pričakovano je zvečanje koncentracij pitavastatina oziroma pravastatina v plazmi.
English: 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.
Slovenian: - opazite, da so vaša koža ali oči postali rumeni - je vaš urin temejši kot običajno
English: 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.
Slovenian: 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
English: 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).
Slovenian: 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).
English: No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh class A).
Slovenian: Pri bolnikih z blago okvaro jeter (razred A po Child-Pughu) prilagajanje odmerkov zdravila OLYSIO ni potrebno.