FrancophonIA/ELRC3.0 huggingface dataset:
English: Eliglustat is also contraindicated in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor.
Slovenian: Eliglustat je kontraindiciran tudi pri bolnikih, ki so slabi presnavljalci (PM) z encimom CYP2D6 in jemljejo kakšen močan zaviralec CYP3A.
English: Percentage of Patients with stable liver volumea
Slovenian: Bolniki s stabilnim volumnom jeter (%)
English: SRT aims to reduce the rate of synthesis of the major substrate glucosylceramide (GL-1) to match its impaired rate of catabolism in patients with GD1, thereby preventing glucosylceramide accumulation and alleviating clinical manifestations.
Slovenian: Zdravljenje z zmanjševanjem substrata (SRT) cilja na zmanjševanje hitrosti sinteze glavnega substrata glukozilceramida (GL-1) tako, da bi ta ustrezala njegovi zmanjšani hitrosti razgradnje pri bolnikih z GD1.
English: Swallow one 84 mg capsule whole twice a day with water.
Slovenian: Dvakrat dnevno z vodo pogoltnite celo kapsulo 84 mg.
English: Caution should be used with weak CYP3A inhibitors in poor metabolisers (PMs).
Slovenian: Previdnost je potrebna pri uporabi šibkih zaviralcev CYP3A pri slabih presnavljalcih (PM).
English: In the Cerdelga group 34 (32%) patients received a dose escalation to 84 mg eliglustat twice daily and 51 (48%) to 127 mg twice daily during the 12month primary analysis period , and 21 (20%) patients continued to receive 42 mg twice daily.
Slovenian: V skupini z zdravilom Cerdelga je v 12-mesečnem obdobju primarne analize 34 (32 %) bolnikov dvakrat dnevno prejemalo odmerek eligustata, ki so ga večali do odmerka 84 mg, 51 (48 %) bolnikov pa dvakrat dnevno odmerek, ki so ga povečevali do 127 mg. 21 (20 %) bolnikov pa je še naprej prejemalo odmerek 42 mg dvakrat dnevno.
English: Table 4: Changes from baseline to Month 12 (primary analysis period) in patients with GD1 switching to Cerdelga in study 02607
Slovenian: Preglednica 4: Spremembe od izhodišča do 12. meseca (obdobje primarne analize) pri bolnikih z GD1, ki so prešli na zdravljenje z zdravilom Cerdelga, v študiji 02607
English: • terbinafine, itraconazole, fluconazole, posaconazole, voriconazole - antifungals (used to treat fungal infections)
Slovenian: • terbinafin, itrakonazol, flukonazol, posakonazol, vorikonazol - antimikotiki (uporabljajo se za zdravljenje glivičnih okužb)
English: • aprepitant - antiemetic (used to reduce vomiting)
Slovenian: • aprepitant - antiemetik (uporablja se za preprečevanje siljenja na bruhanje)
English: • phenytoin - anti-epileptic (used to treat epilepsy and seizures)
Slovenian: • fenitoin - antiepileptik (uporablja se za zdravljenje epilepsije in konvulzij)
English: After a single 0.25 mg dose of digoxin, a P-gp substrate, concomitant administration of 127 mg twice daily doses of eliglustat resulted in a 1.7- and 1.5-fold increase in digoxin Cmax and AUClast, respectively.
Slovenian: Po enkratnem odmerku digoksina (substrata P-glikoproteina) 0,25 mg je sočasno dajanje odmerkov eliglustata 127 mg dvakrat dnevno povzročilo 1,7-kratno zvišanje vrednosti Cmax in 1,5-kratno zvišanje vrednosti AUClast za digoksin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE PACKAGING FOR SINGLE BLISTER SLEEVE
Slovenian: PODATKI NA ZUNANJI OVOJNINI VMESNA OVOJNINA ZA POSAMEZNI PRETISNI OMOT: OVOJ
English: Cerdelga 84 mg hard capsules
Slovenian: IME ZDRAVILA Cerdelga 84 mg trde kapsule
English: - If you are allergic to eliglustat or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Cerdelga Ne jemljite zdravila Cerdelga - če ste alergični na eliglustat ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: The overall adverse reaction profile of Cerdelga is based on 1400 patient-years of treatment exposure and pooled results from the primary analysis periods and extension periods of two pivotal Phase 3 studies (ENGAGE and ENCORE), one 8-year, long term Phase 2 study (Study 304) and one supporting Phase 3b study (EDGE).
Slovenian: 3. faze (ENGAGE in ENCORE), ene 8-letne dolgoročne študije 2. faze (študija 304) in ene podporne študije faze 3b (EDGE).
English: Use of a strong CYP3A inducer (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin, rifabutin and St. John's wort) with eliglustat is not recommended in IMs, EMs and PMs.
Slovenian: Sočasna uporaba močnega spodbujevalca encima CYP3A (npr. rifampicina, karbamazepina, fenobarbitala, fenitoina, rifabutina in šentjanževke) z eliglustatom je odsvetovana pri srednje dobrih (IM), dobrih (EM) in slabih presnavljalcih (PM).
English: The use of a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor is contraindicated in IMs and EMs.
Slovenian: Uporaba močnih ali zmernih zaviralcev CYP2D6 sočasno z močnimi ali zmernimi zaviralci CYP3A je pri IM in EM kontraindicirana.
English: After a single 84 mg dose, eliglustat Cmax and AUC were similar in CYP2D6 extensive metabolisers (EMs) with severe renal impairment and healthy CYP2D6 extensive metabolisers (EMs).
Slovenian: Po enkratnem odmerku 84 mg sta bili Cmax in AUC eliglustata pri dobrih presnavljalcih (EM) s CYP2D6 s hudo okvaro ledvic in pri zdravih dobrih presnavljalcih (EM) s CYP2D6 podobni.
English: Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Slovenian: Zdravilo Cerdelga je indicirano za dolgotrajno zdravljenje Gaucherjeve bolezni tipa 1 (GD1 - Gaucher disease type 1) pri odraslih bolnikih, ki so slabi presnavljalci (PM - poor metabolisers), srednje dobri presnavljalci (IM - intermediate metabolisers) ali dobri presnavljalci (EM - extensive metabolisers) encima CYP2D6.
English: Agents that may increase eliglustat exposure
Slovenian: Snovi, ki lahko vodijo v povišano izpostavljenost eliglustatu
English: Caution should be used with weak CYP3A inhibitors (e.g. amlodipine, cilostazol, fluvoxamine, goldenseal, isoniazid, ranitidine, ranolazine) in PMs.
Slovenian: S šibkimi zaviralci CYP3A (npr. z amlodipinom, cilostazolom, fluvoksaminom, hidrastisom, izoniazidom, ranitidinom, ranolazinom) je pri PM potrebna previdnost.
English: • Bloating (abdominal distension)
Slovenian: • vetrovi (abdominalno napenjanje)
English: A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 inhibitor (e.g. paroxetine, fluoxetine, quinidine, bupropion) is used concomitantly in IMs and EMs.
Slovenian: Odmerk eliglustata 84 mg enkrat dnevno je treba upoštevati pri sočasni uporabi močnega zaviralca encima CYP2D6 (npr. paroksetin, fluoksetin, kinidin, bupropion) pri srednje dobrih (IM) in dobrih presnavljalcih (EM).
English: After repeated 127 mg twice daily doses of eliglustat in non-PMs, concomitant administration of repeated 600 mg once daily doses of rifampicin (a strong inducer of CYP3A as well as the efflux transporter P-gp) resulted in an approximately 85% decrease in eliglustat exposure.
Slovenian: Po ponovljenih odmerkih eliglustata 127 mg dvakrat dnevno pri osebah, ki niso bile slabi presnavljalci, je sočasno dajanje ponovljenih odmerkov rifampicina (močnega spodbujevalca encima CYP3A in efluksnega prenašalca P-glikoproteina) 600 mg enkrat dnevno povzročilo približno 85odstotno znižanje izpostavljenosti eliglustatu.
English: Haemoglobin Level Patients with stable haemoglobin level (%) Change from baseline in Haemoglobin Level (g/dL) Liver Volume Patients with stable liver volume (%)
Slovenian: Prostornina vranice Odstotek bolnikov s stabilno prostornino vranice*a Odstotek spremembe v prostornini vranice MN (%)* Raven hemoglobina Odstotek bolnikov s stabilno ravnjo hemoglobinaa Absolutna sprememba v ravni hemoglobina (g/dl) Prostornina jeter Odstotek bolnikov s stabilno prostornino jetera Odstotek spremembe v prostornini jeter MN (%) Število trombocitov Odstotek bolnikov s stabilnim številom trombocitova Odstotek spremembe v številu trombocitov (%)
English: After a single 50 mg dose of metoprolol, a CYP2D6 substrate, concomitant administration of repeated 127 mg twice daily doses of eliglustat resulted in a 1.5- and 2.1-fold increase in metoprolol Cmax and AUC, respectively.
Slovenian: Po enkratnem odmerku metoprolola (substrata encima CYP2D6) 50 mg je sočasno dajanje ponovljenih odmerkov eliglustata 127 mg dvakrat dnevno vodilo v 1,5-kratno zvišanje vrednosti Cmax in 2,1-kratno zvišanje vrednosti AUC za metoprolol.
English: • Change in taste (dysgeusia)
Slovenian: • sprememba okusa (disgevzija)
English: o Always consult the doctor who prescribed eliglustat before you start using other medicines.
Slovenian: Informacije za bolnika: o Preden začnete jemati kakšna druga zdravila, se morate vedno posvetovati z zdravnikom, ki vam je predpisal eliglustat.
English: • are an intermediate or poor metaboliser and you have any level of reduced liver function.
Slovenian: • če ste srednje dober ali slab presnavljalec in imate kakršnokoli stopnjo zmanjšanega delovanja jeter,
English: Table 1: Tabulated list of adverse reactions
Slovenian: Preglednica 1: Seznam neželenih učinkov v obliki preglednice Organski sistem
English: Pivotal study of Cerdelga in treatment-naïve GD1 patients - study 02507(ENGAGE) Study 02507 was a randomized, double-blind, placebo-controlled, multicenter clinical study in 40 patients with GD1.
Slovenian: Študija 02507 je bila randomizirana, dvojno slepa, s placebom nadzorovana, multicentrična klinična študija pri 40 bolnikih z GD1.
English: After repeated 84 mg once daily doses of Cerdelga, Cmax and AUC0-24 are predicted to be 3.1- and 3.2fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs ) receiving Cerdelga 84 mg twice daily (see sections 4.2 and 4.4).
Slovenian: Po ponavljajočih se odmerkih 84 mg zdravila Cerdelga enkrat na dan je pri dobrih presnavljalcih (EM) s CYP2D6 z zmerno okvaro jeter Cmax predvidoma 3,1-krat večja in AUC0-24 predvidoma 3,2-krat večja kot pri zdravih dobrih presnavljalcih (EM) s CYP2D6, ki so prejemali 84 mg zdravila Cerdelga dvakrat na dan (glejte poglavji 4.2 in 4.4).
English: • colchicine - used to treat gout
Slovenian: • kolhicin - uporablja se za zdravljenje protina
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora draženje grla
English: Spleen Volume
Slovenian: Volumen vranice
English: Caution should be used with strong or moderate CYP3A inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Slovenian: Previdnost je potrebna pri uporabi močnih ali zmernih zaviralcev CYP3A pri srednje dobrih presnavljalcih (IM) in dobrih presnavljalcih (EM).
English: Haemoglobin Level Percentage of Patients with stable haemoglobin levela
Slovenian: Koncentracija hemoglobina Bolniki s stabilno koncentracijo hemoglobina (%)
English: Year 4
Slovenian: 4. leto
English: Due to significantly increased eliglustat plasma concentrations, Cerdelga is contraindicated in CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment and in CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor (see sections 4.2 and 5.2).
Slovenian: Zaradi bistveno zvišane koncentracije eliglustata v plazmi je zdravilo Cerdelga kontraindicirano pri dobrih presnavljalcih (EM) s CYP2D6 s hudo okvaro jeter ter pri dobrih presnavljalcih (EM) s CYP2D6 z blago ali zmerno okvaro jeter, ki hkrati jemljejo močan ali zmeren zaviralec CYP2D6 (glejte poglavji 4.2 in 5.2).
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that the concomitant use of strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors would increase Cmax and AUC0-12 up to 17- and 25-fold, respectively.
Slovenian: Pri bolnikih, ki niso slabi presnavljalci, bo ob uporabi 84 mg eliglustata dvakrat na dan sočasna uporaba močnih ali zmernih zaviralcev CYP2D6 ter močnih ali zmernih zaviralcev CYP3A predvidoma povečala Cmax eliglustata za 17-krat in njegovo AUC0-12 za 25,0-krat.
English: Steady state PK exposure could not be predicted in CYP2D6 intermediate metabolisers (IMs) and poor metabolisers (PMs) with mild and moderate hepatic impairment due to limited or no single-dose data.
Slovenian: Izpostavljenosti v stanju farmakokinetičnega dinamičnega ravnovesja pri srednje dobrih (IM) in slabih (PM) presnavljalcih s CYP2D6 z blago in zmerno okvaro jeter ni bilo mogoče predvideti, ker je podatkov o uporabi enkratnega odmerka malo ali jih ni.
English: The recommended dose is 84 mg eliglustat once daily in CYP2D6 poor metabolisers (PMs).
Slovenian: Priporočeni odmerek je 84 mg eliglustata enkrat dnevno pri slabih presnavljalcih (PM) encima CYP2D6.
English: Year 3
Slovenian: 3. leto
English: • dronedarone, quinidine, verapamil - antiarrhythmic medicines (used to treat irregular heartbeat)
Slovenian: • dronedaron, kinidin, verapamil - antiaritmiki (uporabljajo se za zdravljenje nepravilnega srčnega utripa)
English: o Do not consume grapefruit products.
Slovenian: o Ne uživajte grenivk in izdelkov iz njih.
English: • Joint pain (arthalagia)
Slovenian: • bolečine v sklepih (artralgija)
English: After repeated 84 mg twice daily doses of eliglustat in non-PMs, concomitant administration with repeated 30 mg once daily doses of paroxetine, a strong inhibitor of CYP2D6, resulted in a 7.3- and 8.9-fold increase in eliglustat Cmax and AUC0-12, respectively.
Slovenian: Po ponovljenih odmerkih eliglustata 84 mg dvakrat dnevno pri osebah, ki niso bile slabi presnavljalci, je sočasno dajanje ponovljenih odmerkov paroksetina (močnega zaviralca encima CYP2D6) 30 mg enkrat dnevno povzročilo 7,3-kratno zvišanje vrednosti Cmax in 8,9-kratno zvišanje vrednosti AUC0-12 za eliglustat.
English: Medicines that may decrease the level of Cerdelga in the blood:
Slovenian: Zdravila, ki lahko vodijo v znižano raven zdravila Cerdelga v krvi, kot so:
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of moderate CYP2D6 inhibitors (e.g. duloxetine, terbinafine, moclobemide, mirabegron, cinacalcet, dronedarone) would increase eliglustat exposure approximately up to 4-fold.
Slovenian: Pri odmerku eliglustata 84 mg dvakrat dnevno pri osebah, ki niso bile slabi presnavljalci, naj bi sočasna uporaba zmernih zaviralcev encima CYP2D6 (npr. duloksetin, terbinafin, moklobemid, mirabegron, cinakalcet, dronedaron) za približno do 4-krat zvišala izpostavljenost eliglustatu.
English: Table 2: Change from baseline to Month 9 (primary analysis period) in treatment-naïve patients with GD1 receiving treatment with Cerdelga in study 02507
Slovenian: Preglednica 2: Sprememba od izhodišča do 9. meseca (obdobje primarne analize) pri bolnikih z GD1, ki predhodno niso bili zdravljeni, zdaj pa so deležni zdravljenja z zdravilom Cerdelga, v študiji 02507
English: o Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).
Slovenian: Vodnik za zdravnike, ki predpisujejo zdravilo mora vsebovati naslednje ključne elemente: o Zdravilo Cerdelga je indicirano za dolgotrajno zdravljenje odraslih bolnikov z Gaucherjevo boleznijo tipa 1 (GD1).
English: Please speak to your doctor regarding these medicines before you start taking Cerdelga.
Slovenian: Pred začetkom jemanja zdravila Cerdelga se o teh zdravilih posvetujte s svojim zdravnikom.
English: • Stomach ache (upper abdominal pain)
Slovenian: • bolečine v želodcu (bolečine v zgornjem abdominalnem delu)
English: Patients with hepatic impairment
Slovenian: Bolniki z okvarjenim delovanjem ledvic
English: • atomoxetine - used to treat attention deficit hyperactivity disorder (ADHD) • pravastatin - used to lower cholesterol and prevent heart disease
Slovenian: • pravastatin - uporablja se za zniževanje holesterola in preprečevanje srčnih bolezni
English: In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with mild, moderate or severe renal impairment or ESRD, eliglustat is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri srednje dobrih (IM) ali slabih presnavljalcih (PM) s CYP2D6 z blago, zmerno ali hudo okvaro ledvic ali ESRD uporaba eliglustata ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: Each capsule contains 84.4 mg of eliglustat (as tartrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena kapsula vsebuje 84,4 mg eliglustata (v obliki tartrata).
English: • Hives (urticaria)
Slovenian: • izpuščaji (urtikarija)
English: Placental transfer of eliglustat and its metabolites was shown in the rat.
Slovenian: Pri podganah so opazili prehajanje eliglustata in njegovih presnovkov skozi placento.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / WALLET
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: • are an intermediate or poor metaboliser and you have reduced kidney function.
Slovenian: • če ste srednje dober ali slab presnavljalec in imate zmanjšano delovanje ledvic,
English: How to store Cerdelga
Slovenian: Shranjevanje zdravila Cerdelga
English: Arthralgia, pain in extremity*, back pain* General disorders and administration site conditions Fatigue
Slovenian: Artralgija, bolečine v ekstremitetah*, bolečina v križu*
English: • Dry mouth
Slovenian: • draženje grla
English: After a single 84 mg dose, eliglustat Cmax and AUC were 1.2- and 1.2-fold higher in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment, and 2.8- and 5.2-fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs).
Slovenian: Po enkratnem odmerku 84 mg eliglustata je bila pri dobrih presnavljalcih (EM) s CYP2D6 in blago okvaro jeter Cmax 1,2-krat večja in AUC 1,2-krat večja, pri dobrih presnavljalcih (EM) s CYP2D6 in zmerno okvaro jeter pa Cmax 2,8-krat večja in AUC 5,2-krat večja kot pri zdravih dobrih presnavljalcih (EM) s CYP2D6.
English: How to pull the blister/wallet from the sleeve
Slovenian: PRETISNI OMOT/ZGIBANKA
English: After repeated 84 mg twice daily doses of Cerdelga, Cmax and AUC0-12 are predicted to be 2.4- and 2.9fold higher in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment and 6.4- and 8.9fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs).
Slovenian: Po ponavljajočih se odmerkih zdravila Cerdelga 84 mg dvakrat na dan je pri dobrih presnavljalcih (EM) s CYP2D6 z blago okvaro jeter Cmax predvidoma 2,4-krat večja in AUC0-12 predvidoma 2,9-krat večja, pri dobrih presnavljalcih (EM) s CYP2D6 z zmerno okvaro jeter pa je Cmax predvidoma 6,4-krat večja in AUC0-12 predvidoma 8,9-krat večja kot pri zdravih dobrih presnavljalcih (EM) s CYP2D6.
English: In CYP2D6 EMs with end stage renal disease (ESRD), eliglustat is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri dobrih presnavljalcih (EM) s CYP2D6 s končno odpovedjo ledvic (ESRD- end stage renal disease) uporaba eliglustata ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: p valueb
Slovenian: Vrednost pb
English: At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, boceprevir) would increase the Cmax and AUC0-24 of eliglustat 4.3- and 6.2-fold.
Slovenian: Ob uporabi 84 mg eliglustata enkrat na dan pri PM bo sočasna uporaba močnih zaviralcev CYP3A (npr. ketokonazola, klaritromicina, itrakonazola, kobicistata, indinavirja, lopinavirja, ritonavirja, sakvinavirja, telaprevirja, tipranavirja, posakonazola, vorikonazola, telitromicina, konivaptana, boceprevirja) predvidoma povečala Cmax eliglustata za 4,3-krat in njegovo AUC0-24 za 6,2-krat.
English: Spleen Volume Patients with stable spleen volume (%)*
Slovenian: Bolniki s stabilnim volumnom vranice (%)* Sprememba volumna vranice MN (%)*
English: At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of moderate CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase the Cmax and AUC0-24 of eliglustat 2.4- and 3.0-fold, respectively.
Slovenian: Ob uporabi 84 mg eliglustata enkrat na dan pri PM bo sočasna uporaba zmernih zaviralcev CYP3A (npr. eritromicina, ciprofloksacina, flukonazola, diltiazema, verapamila, aprepitanta, atazanavirja, darunavirja, fosamprenavirja, imatiniba, cimetidina) predvidoma povečala Cmax eliglustata za 2,4-krat in njegovo AUC0-24 za 3,0-krat.
English: CYP2D6 ultra-rapid metabolisers (URMs) and indeterminate metabolisers Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or indeterminate metabolisers (see section 4.4).
Slovenian: Eliglustata se ne sme uporabljati pri bolnikih, ki so ultra dobri presnavljalci (URM) ali pri osebah z neugotovljenim/nedoločenim presnavljalskim statusom) encima CYP2D6 (glejte poglavje 4.4).
English: In CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment (Child-Pugh class B), eliglustat is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri dobrih presnavljalcih (EM) s CYP2D6, ki imajo zmerno okvaro jeter (Child-Pugh razred B), uporaba eliglustata ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: 14 hard capsules
Slovenian: 56 trdih kapsul
English: • are an extensive metaboliser and you have moderately reduced liver function.
Slovenian: • če ste hiter presnavljalec in imate zmerno zmanjšano delovanje jeter,
English: o In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat once daily should be considered.
Slovenian: o Pri dobrih presnavljalcih (EM) s CYP2D6 z blago okvaro jeter, ki jemljejo šibek zaviralec CYP2D6 ali močan, zmeren ali šibek zaviralec CYP3A, je treba razmisliti o odmerku 84 mg eliglustata enkrat na dan.
English: • are taking an antiarrhythmic medicine (used to treat irregular heart beat) like quinidine,
Slovenian: • če jemljete antiaritmike (ki se uporabljajo za zdravljenje nepravilnega srčnega utripa), kot so kinidin, amiodaron ali sotalol.
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of moderate CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase eliglustat exposure approximately up to 3-fold.
Slovenian: Pri odmerku eliglustata 84 mg dvakrat dnevno pri osebah, ki niso bile slabi presnavljalci, naj bi sočasna uporaba zmernih zaviralcev encima CYP3A (npr. eritromicin, ciprofloksacin, flukonazol, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidin) za približno 3-krat zvišala izpostavljenost eliglustatu.
English: In extensive metabolisers (EMs) with moderate or severe hepatic impairment: see sections 4.2 and 4.3.
Slovenian: Pri dobrih presnavljalcih (EM) z zmerno ali hudo okvaro jeter: glejte poglavji 4.2 in 4.3
English: Patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor.
Slovenian: Bolniki, ki so srednje dobri presnavljalci (IM) ali dobri presnavljalci (EM) encima CYP2D6 in jemljejo močan ali zmeren zaviralec encima CYP2D6 sočasno z močnim ali zmernim zaviralcem encima CYP3A in bolniki, ki so slabi presnavljalci (PM) encima CYP2D6 in jemljejo močan zaviralec encima CYP3A.