natgillin/translations-raw huggingface dataset:
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).
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).
• colchicine - used to treat gout
• kolhicin - uporablja se za zdravljenje protina
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora draženje grla
Spleen Volume
Volumen vranice
Caution should be used with strong or moderate CYP3A inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Previdnost je potrebna pri uporabi močnih ali zmernih zaviralcev CYP3A pri srednje dobrih presnavljalcih (IM) in dobrih presnavljalcih (EM).
Haemoglobin Level Percentage of Patients with stable haemoglobin levela
Koncentracija hemoglobina Bolniki s stabilno koncentracijo hemoglobina (%)
Year 4
4. leto
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).
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).
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.
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.
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.
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.
The recommended dose is 84 mg eliglustat once daily in CYP2D6 poor metabolisers (PMs).
Priporočeni odmerek je 84 mg eliglustata enkrat dnevno pri slabih presnavljalcih (PM) encima CYP2D6.
Year 3
3. leto
• dronedarone, quinidine, verapamil - antiarrhythmic medicines (used to treat irregular heartbeat)
• dronedaron, kinidin, verapamil - antiaritmiki (uporabljajo se za zdravljenje nepravilnega srčnega utripa)
o Do not consume grapefruit products.
o Ne uživajte grenivk in izdelkov iz njih.
• Joint pain (arthalagia)
• bolečine v sklepih (artralgija)
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.
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.
Medicines that may decrease the level of Cerdelga in the blood:
Zdravila, ki lahko vodijo v znižano raven zdravila Cerdelga v krvi, kot so:
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.
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.
Table 2: Change from baseline to Month 9 (primary analysis period) in treatment-naïve patients with GD1 receiving treatment with Cerdelga in study 02507
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
o Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).
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).
Please speak to your doctor regarding these medicines before you start taking Cerdelga.
Pred začetkom jemanja zdravila Cerdelga se o teh zdravilih posvetujte s svojim zdravnikom.
• Stomach ache (upper abdominal pain)
• bolečine v želodcu (bolečine v zgornjem abdominalnem delu)
Patients with hepatic impairment
Bolniki z okvarjenim delovanjem ledvic
• atomoxetine - used to treat attention deficit hyperactivity disorder (ADHD) • pravastatin - used to lower cholesterol and prevent heart disease
• pravastatin - uporablja se za zniževanje holesterola in preprečevanje srčnih bolezni
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).
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).
Each capsule contains 84.4 mg of eliglustat (as tartrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena kapsula vsebuje 84,4 mg eliglustata (v obliki tartrata).
• Hives (urticaria)
• izpuščaji (urtikarija)
Placental transfer of eliglustat and its metabolites was shown in the rat.
Pri podganah so opazili prehajanje eliglustata in njegovih presnovkov skozi placento.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / WALLET
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
• are an intermediate or poor metaboliser and you have reduced kidney function.
• če ste srednje dober ali slab presnavljalec in imate zmanjšano delovanje ledvic,
How to store Cerdelga
Shranjevanje zdravila Cerdelga
Arthralgia, pain in extremity*, back pain* General disorders and administration site conditions Fatigue
Artralgija, bolečine v ekstremitetah*, bolečina v križu*
• Dry mouth
• draženje grla
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).
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.
How to pull the blister/wallet from the sleeve
PRETISNI OMOT/ZGIBANKA
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).
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.
In CYP2D6 EMs with end stage renal disease (ESRD), eliglustat is not recommended (see sections 4.4 and 5.2).
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).
p valueb
Vrednost pb
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.
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.
Spleen Volume Patients with stable spleen volume (%)*
Bolniki s stabilnim volumnom vranice (%)* Sprememba volumna vranice MN (%)*
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.
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.
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).
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).
In CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment (Child-Pugh class B), eliglustat is not recommended (see sections 4.4 and 5.2).
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).
14 hard capsules
56 trdih kapsul
• are an extensive metaboliser and you have moderately reduced liver function.
• če ste hiter presnavljalec in imate zmerno zmanjšano delovanje jeter,
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.
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.
• are taking an antiarrhythmic medicine (used to treat irregular heart beat) like quinidine,
• če jemljete antiaritmike (ki se uporabljajo za zdravljenje nepravilnega srčnega utripa), kot so kinidin, amiodaron ali sotalol.
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.
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.
In extensive metabolisers (EMs) with moderate or severe hepatic impairment: see sections 4.2 and 4.3.
Pri dobrih presnavljalcih (EM) z zmerno ali hudo okvaro jeter: glejte poglavji 4.2 in 4.3
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.
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.
o Eliglustat is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) who are taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor.
o Eliglustat je kontraindiciran pri bolnikih, ki so srednje dobri (IM) ali dobri presnavljalci (EM) z encimom CYP2D6 in jemljejo kakšen močan ali zmeren zaviralec CYP2D6 hkrati z močnim ali zmernim zaviralcem CYP3A.
o Caution should be used with moderate CYP2D6 inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Pri uporabi zmernih zaviralcev encima CYP2D6 je potrebna previdnost pri srednje dobrih (IM) in dobrih presnavljalcih (EM).
In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat mg once daily should be considered (see sections 4.2 and 5.2).
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 (glejte poglavji 4.2 in
Cerdelga is indicated in patients who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Zdravilo Cerdelga je indicirano pri bolnikih, ki so slabi presnavljalci (PM), srednje dobri presnavljalci (IM) ali dobri presnavljalci (EM) encima CYP2D6.
Eliglustat is an inhibitor of P-gp and CYP2D6 in vitro; concomitant administration of eliglustat with P-gp or CYP2D6 substrate substances may increase the plasma concentration of those substances.
Sočasno jemanje eliglustata s substrati P-glikoproteina ali encima CYP2D6 lahko vodi v povečanje njihovih plazemskih koncentracij.
Each capsule contains 84 mg of eliglustat (as tartrate)
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 84 mg eliglustata (v obliki tartrata).
In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, eliglustat is not recommended (see sections 4.4 and 5.2).
Pri srednje dobrih presnavljalcih (IM) ali pri slabih presnavljalcih (PM) s CYP2D6 s katerokoli stopnjo jetrne okvare uporaba eliglustata ni priporočljiva (glejte poglavji 4.4 in 5.2).
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 (see sections 4.4 and 5.2).
Pri dobrih presnavljalcih (EM) s CYP2D6, ki imajo blago okvaro jeter in hkrati jemljejo šibek zaviralec CYP2D6 ali močan, zmeren ali blag zaviralec CYP3A, je treba razmisliti o uporabi odmerka 84 mg eliglustata enkrat na dan (glejte poglavji 4.4 in 5.2).
N Baseline Value (Mean)
N Izhodiščna vrednost (povprečna)
The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Priporočeni odmerek je 84 mg eliglustata dvakrat dnevno pri srednje dobrih (IM) ali dobrih presnavljalcih (EM) encima CYP2D6.
Cerdelga is contraindicated in 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 in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor (see section 4.3).
Zdravilo Cerdelga je kontraindicirano pri bolnikih, 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 pri bolnikih, ki so slabi presnavljalci (PM) encima CYP2D6 in jemljejo močan zaviralec encima CYP3A (glejte poglavje 4.3).
Limited data are available in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment.
Podatkov o dobrih presnavljalcih (EM) s CYP2D6, ki imajo zmerno okvaro jeter, je malo.
Study 304 was a single-arm, open-label, multicenter study of Cerdelga in 26 patients.
Dolgotrajni klinični rezultati pri bolnikih z GD1, ki predhodno niso bili zdravljeni - študija 304 Študija 304 je bila enoskupinska, odprta, multicentrična študija zdravila Cerdelga pri 26 bolnikih.
In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class C) hepatic impairment, eliglustat is contraindicated (see sections 4.3 and 5.2).
Eliglustat je kontraindiciranpri dobrih presnavljalcih (EM) s CYP2D6, ki imajo hudo okvaro jeter (Child-Pugh razred C) (glejte poglavji 4.3 in 5.2).
CYP2D6 phenotype
Fenotip encima CYP2D 6
b Estimates and p-values are based on an ANCOVA model * All patients transitioned to Cerdelga treatment after Month 9.
b Predvidene vrednosti in vrednosti p temeljijo na modelu ANCOVA
Limited or no data were available in patients with ESRD and in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers(PMs) with severe renal impairment (see sections 4.2 and 4.4).
Pri bolnikih z ESRD in pri srednje dobrih presnavljalcih (IM) ali slabih presnavljalcih (PM) s hudo okvaro ledvic je podatkov malo ali jih ni (glejte poglavji 4.2 in 4.4).
o In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, Cerdelga is not recommended.
o Uporaba zdravila Cerdelga ni priporočljiva pri srednje dobrih (IM) ali slabih presnavljalcih (PM) s kakršnokoli stopnjo okvare jeter.
CYP2D6 inhibitors used simultaneously with CYP3A inhibitors In intermediate (IMs) and extensive metabolisers (EMs):
Zaviralci CYP2D6, uporabljeni sočasno z zaviralci CYP3A
Contents of the pack and other information What Cerdelga contains
Shranjevanje zdravila Cerdelga Vsebina pakiranja in dodatne informacije
What you need to know before you take Cerdelga 3.
Kaj je zdravilo Cerdelga in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Cerdelga Kako jemati zdravilo Cerdelga Možni neželeni učinki
In extensive metabolisers (EMs) with mild or moderate hepatic impairment: see sections 4.2, 4.3 and
Pri dobrih presnavljalcih (EM) z blago ali zmerno okvaro jeter: glejte poglavja 4.2., 4.3 in 4.4.
PHARMACEUTICAL FORM AND CONTENTS
FARMACEVTSKA OBLIKA IN VSEBINA 14 trdih kapsul
Use of a moderate CYP3A inhibitor with eliglustat is not recommended in PMs.
Pri PM hkrati z eliglustatom ni priporočljivo uporabljati zmernih zaviralcev CYP3A.
Long-term clinical outcomes in treatment-naïve GD1 patients - study 304
Ključna študija zdravila Cerdelga pri bolnikih z GD1, ki predhodno niso bili zdravljeni - študija 02507 (ENGAGE)
In extensive metabolisers (EMs) with mild hepatic impairment: see sections 4.2 and 4.4.
Pri dobrih presnavljalcih (EM) z blago okvaro jeter: glejte poglavji 4.2. in 4.4.
Limited or no data are available in CYP2D6 extensive metabolisers (EMs), intermediate metabolisers (IMs) or poor metabolisers (PMs) with ESRD and in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with mild, moderate, or severe renal impairment; use of eliglustat in these patients is not recommended (see sections 4.2 and 5.2).
Podatkov o dobrih presnavljalcih (EM), srednje dobrih presnavljalcih (IM) ali slabih presnavljalcih (PM) s CYP2D6, z ESRD ter o srednje dobrih presnavljalcih (IM) ali slabih presnavljalcih (PM) s CYP2D6, z blago, zmerno ali hudo okvaro ledvic, je malo ali jih ni.
o In CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment, Cerdelga is contraindicated.
o Zdravilo Cerdelga je kontraindicirano pri dobrih presnavljalcih (EM) s CYP2D6 s hudo okvaro jeter.
Caution should be used with moderate CYP3A inhibitors in IMs and EMs.
Pri uporabi zmernih zaviralcev encima CYP3A je potrebna previdnost pri srednje dobrih (IM) in dobrih presnavljalcih (EM).
In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment (Child-Pugh class A), no dosage adjustment is required and the recommended dose is 84 mg eliglustat twice daily.
o Priporočeni odmerek eliglustata pri srednje dobrih (IM) in dobrih presnavljalcih (EM) encima CYP2D6 je 84 mg dvakrat na dan. Priporočeni odmerek eliglustata pri slabih presnavljalcih (PM) z encimom CYP2D6 je 84 mg enkrat na dan.
Caution should be used with strong CYP3A inhibitors in IMs and EMs.
Pri uporabi močnih zaviralcev encima CYP3A je potrebna previdnost pri srednje dobrih (IM) in dobrih presnavljalcih (EM).
Limited or no data are available in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment.
Podatkov o srednje dobrih presnavljalcih (IM) ali slabih presnavljalcih (PM) s kakršno koli stopnjo okvare jeter, je malo ali jih ni.
In CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor, Cerdelga is contraindicated (see sections 4.3 and 5.2).
Zdravilo Cerdelga je kontraindicirano pri dobrih presnavljalcih (EM) s CYP2D6, ki imajo blago okvaro jeter in hkrati jemljejo močan ali zmeren zaviralec CYP2D6 (glejte poglavji 4.3 in 5.2).
Date of first authorisation: 14 April 2011 Date of first renewal: 18 February 2016
Datum prve odobritve: 14. april 2011 Datum prvega podaljšanja: 18. februar 2016
Therefore, your baby may be protected from certain infections.
Zato je vaš dojenček morda zaščiten pred določenimi okužbami.
Produced from the plasma of human donors.
Narejeno iz plazme človeških darovalcev.
• there has been a long interval (more than eight weeks) since the previous infusion.
• je od zadnjega infundiranja poteklo dlje časa (več kot osem tednov).
Please refer also to section 5.1.
Glejte tudi poglavje 5.1.
This includes conditions such as:
To vključuje bolezni, kot so:
This may need to be divided over several days.
Ta se lahko porazdeli na več dni.
You will be instructed in:
Dobili boste navodila za:
If this happens, you should not drive or use machines until these effects have disappeared.
Če se to zgodi, ne smete voziti ali upravljati s stroji, dokler ti učinki ne izzvenijo.
• measures to be taken in case of severe side effects.
• ukrepe v primeru resnih neželenih učinkov.
Consequences of an overdose are not known.
Posledice prevelikega odmerka niso znane.
If large doses are given (> 50 ml), try to administer them at multiple sites.
Če se dajejo veliki odmerki (> 50 ml), jih poskušajte dati na več mestih.
Infusion parameter and responder rate (%)
Parameter infundiranja in delež odziva (%)
In these cases, it is recommended that you are monitored during the first infusion and for an hour afterwards.
V teh primerih vas morajo spremljati med prvim infundiranjem in še eno uro po njem.
Do not use solutions that have been frozen.
Ne uporabljajte raztopin, ki so bile zamrznjene.
► into a blood vessel.
► v krvno žilo.
All other patients should be observed for at least 20 minutes after administration.
Vse druge bolnike je treba opazovati vsaj 20 minut po dajanju zdravila.