FrancophonIA/ELRC3.0 huggingface dataset:
English: Eliglustat is extensively metabolized with high clearance, mainly by CYP2D6 and to a lesser extent CYP3A4.
Danish: Eliglustat metaboliseres i udpræget grad med høj clearance, hovedsageligt af CYP2D6 og i mindre grad af CYP3A4.
English: - If you are an extensive metaboliser and you have mildly or moderately reduced liver function while taking a strong or moderate CYP2D6 inhibitor.
Danish: - Hvis du er en ekstensiv metabolisator, og du har let eller moderat nedsat leverfunktion, samtidig med at du tager en stærk eller moderat CYP2D6-hæmmer.
English: Use of eliglustat under these conditions results in substantially elevated plasma concentrations of eliglustat.
Danish: Brugen af eliglustat under disse forhold resulterer i væsentligt forhøjede plasmakoncentrationer af eliglustat.
English: Concomitant use of eliglustat with CYP2D6 or CYP3A4 inhibitors in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment can result in further elevation of eliglustat plasma concentrations, with the magnitude of the effect depending on the enzyme inhibited and the potency of the inhibitor.
Danish: Samtidig brug af eliglustat med CYP2D6- eller CYP3A4-hæmmere hos CYP2D6-ekstensive metabolisatorer (EM'er) med let nedsat leverfunktion kan resultere i en yderligere forhøjelse af eliglustat-plasmakoncentrationerne, hvor omfanget af denne effekt afhænger af det hæmmede enzym og hæmmerens styrke.
English: • Change in taste (dysgeusia)
Danish: • Smagsforstyrrelser (dysgeusi)
English: Medicines that may decrease the level of Cerdelga in the blood:
Danish: Lægemidler, der kan reducere mængden af Cerdelga i blodet:
English: - If you are an intermediate or extensive metaboliser and use medicines known as strong or moderate CYP2D6 inhibitors (examples are quinidine and terbinafine) used in combination with strong or moderate CYP3A inhibitors (examples are erythromycin and itraconazole).
Danish: - hvis du er en intermediær eller ekstensiv metabolisator, og bruger lægemidler, der er kendt under betegnelsen potente eller moderate CYP2D6-hæmmere (eksempler er quinidin og terbinafin), der anvendes i kombination med potente eller moderate CYP3A-hæmmere (eksempler er erythromycin og itraconazol).
English: Agents that may decrease eliglustat exposure
Danish: Stoffer, der kan mindske eliglustat-eksponeringen
English: Eliglustat is metabolised primarily by CYP2D6 and to a lesser extent by CYP3A4.
Danish: Eliglustat metaboliseres primært af CYP2D6 og i mindre grad af CYP3A4.
English: • phenothiazines - antipsychotics (used to treat schizophrenia and psychosis)
Danish: • phenothiaziner - antipsykotika (bruges til at behandle skizofreni og psykose)
English: 5% (40.57%) [n=39], 74.6% (49.57%) [n=35], and 86.8% (54.20%) [n=12]; mean reduction in spleen volume (MN) 46.5% (9.75%) [n=38], 54.2% (9.51%) [n=32], and 65.6% (7.43%) [n=13]; and mean reduction in liver volume (MN) 13.7% (10.65%) [n=38], 18.5% (11.22%) [n=32], and 23.4% (10.59%) [n=13].
Danish: Resultater (ændring i forhold til baseline) efter 18 måneder, 30 måneder og 4,5 års eksponering for Cerdelga på følgende endepunkter var: absolut ændring i hæmoglobinniveau (g/dl) 1,1 (1,03) [n=39]; 1,4 (0,93) [n=35]; og 1,4 (1,31) [n=12]; gennemsnitlig stigning i trombocyttal (mm3) 58,5% (40,57%) [n=39]; 74,6% (49,57%) [n=35]; og 86,8% (54,20%) [n=12]; gennemsnitlig reduktion i miltvolumen(MN) 46,5% (9,75%) [n=38]; 54,2% (9,51%) [n=32]; og 65,6% (7,43%) [n=13]; og gennemsnitlig reduktion i levervolumen (MN) 13,7% (10,65%) [n=38]; 18,5% (11,22%)
English: How to pull the blister/wallet from the sleeve
Danish: Sådan trækkes blisterpakken/kortet ud af hylsteret.
English: o Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1).
Danish: • Cerdelga er indiceret til langtidsbehandling af voksne patienter med Gauchers sygdom type 1 (Gauchers Disease type 1, GD1).
English: Caution should be used with weak CYP3A inhibitors (e.g. amlodipine, cilostazol, fluvoxamine, goldenseal, isoniazid, ranitidine, ranolazine) in PMs.
Danish: Der bør udvises forsigtighed, når det bruges sammen med svage CYP3A-hæmmere (f.eks. amlodipin, cilostazol, fluvoxamin, gyldensegl, isoniazid, ranitidin, ranolazin) hos PM'er.
English: PETG/COC.PETG/PCTFE-aluminium blister Each blister wallets contains 14 hard capsules.
Danish: PETG/COC.PETG/PCTFE-aluminium blister
English: CYP2D6 phenotype
Danish: CYP2D6 fænotype
English: Year 4
Danish: År 4
English: • atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir antiretrovirals (used to treat HIV)
Danish: • atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir antiretrovirale lægemidler (bruges til at behandle HIV)
English: These medicines are known as strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors.
Danish: Disse lægemidler er kendt som potente eller moderate CYP2D6-hæmmere og potente eller moderate CYP3A-hæmmere.
English: Mean [95% CI]
Danish: [95% CI]
English: • paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide - antidepressants (used to treat depression)
Danish: • paroxetin, fluoxetin, fluvoxamin, duloxetin, bupropion, moclobemid - antidepressiva (bruges til at behandle depression)
English: • terbinafine, itraconazole, fluconazole, posaconazole, voriconazole - antifungals (used to treat fungal infections)
Danish: • terbinafin, itraconazol, fluconazol, posaconazol, voriconazol - antisvampemidler (bruges til at behandle svampeinfektioner)
English: • carbamazepine, phenobarbital, phenytoin -anti-epileptics (used to treat epilepsy and seizures)
Danish: • carbamazepin, phenobarbital, phenytoin -anti-epileptika (bruges til at behandle epilepsi og anfald)
English: • conivaptan - diuretic (used to increase low blood sodium levels)
Danish: • conivaptan - diuretika (bruges til at øge et lavt indhold af natrium i blodet)
English: N Baseline Value (Mean)
Danish: N Baselineværdi (middel)
English: Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide is not effectively broken down by your body.
Danish: Gauchers sygdom type 1 er en sjælden, arvelig sygdom, hvor et stof betegnet glucosylceramid ikke nedbrydes af kroppen på effektiv vis. Som følge heraf hober glucosylceramid sig op i milten, leveren og knoglerne.
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).
Danish: Cerdelga er indiceret til langtidsbehandling af voksne patienter med Gauchers sygdom type 1 (GD1), som er CYP2D6-langsomme metabolisatorer (poor metabolisers, PM'er), intermediære metabolisatorer (IM'er) eller ekstensive metabolisatorer (EM'er).
English: The predicted exposures with 84 mg eliglustat once daily in patients who are PMs are expected to be similar to exposures observed with 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs).
Danish: De forudsagte eksponeringer med 84 mg eliglustat en gang om dagen hos patienter, som er PM'er, forventes at ligne de eksponeringer, der blev observeret med 84 mg eliglustat to gange dagligt hos CYP2D6-intermediære metabolisatorer (IM'er).
English: Use of Cerdelga under these conditions results in substantially elevated eliglustat plasma concentrations.
Danish: Brug af Cerdelga under disse forhold giver anledning til væsentligt forhøjede eliglustat-plasmakoncentrationer.
English: Adverse reactions from long term clinical trial data reported in at least 4 patients are presented in Table 1.Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Alle bivirkninger fra langsigtede kliniske forsøgsdata indberettet hos mindst 4 patienter er vist i tabel 1.
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.
Danish: Steady state PK-eksponering kunne ikke forudsiges hos CYP2D6-intermediære metabolisatorer (IM'er) og langsomme metabolisatorer (PM'er) med let og moderat nedsat leverfunktion på grund af begrænsede eller ingen enkeltdosisdata.
English: Percentage Change in Spleen Volume MN (%)*
Danish: Procentvis ændring i miltvolumen MN (%)*
English: Shellac
Danish: Schellak
English: For use of eliglustat with one strong or moderate inhibitor of CYP2D6 or CYP3A, see section 4.5.
Danish: Ved brug af eliglustat med en stærk eller moderat CYP2D6-hæmmer eller CYP3A, se pkt.
English: The use of strong CYP3A inhibitors is contraindicated in PMs.
Danish: Brugen af potente CYP3A-hæmmere er kontraindikeret hos PM'er.
English: Table 5: Changes from Month 12 (primary analysis period) to Month 48 in patients with GD1 in the Long Term Treatment Period on Cerdelga in study 02607
Danish: Tabel 5: Ændringer fra måned 12 (primær analyseperiode) til måned 48 hos patienter med GD1 i perioden med langtidsbehandling med Cerdelga i studie 02607
English: Medicines of this type will interfere with your body's abilty to break down Cerdelga and this can result in higher levels of the active substance in your blood (see the section ‘Other medicines and Cerdelga' for an expanded list of medicines).
Danish: Denne type medicin vil forstyrre din krops evne til at nedbryde Cerdelga, og det kan resultere i højere niveauer af det aktive stof i dit blod (se afsnittet “Brug af anden medicin sammen med Cerdelga” for en udvidet medicinliste).
English: Table 4: Changes from baseline to Month 12 (primary analysis period) in patients with GD1 switching to Cerdelga in study 02607
Danish: Tabel 4: Ændringer fra baseline til måned 12 (primær analyseperiode) hos patienter med GD1, som skiftede til Cerdelga i studie 02607
English: Use of a moderate CYP3A inhibitor with eliglustat is not recommended in PMs.
Danish: Anvendelse af en moderat CYP3A-hæmmer sammen med eliglustat anbefales ikke hos PM´er.
English: Drug-drug interactions
Danish: Lægemiddel-interaktioner
English: • St. John's wort - (also known as Hypericum perforatum) a herbal preparation obtained without a prescription, used to treat depression and other conditions
Danish: • Perikum - (også kendt som Hypericum perforatum) et naturlægemiddel, der kan købes uden recept og anvendes til at behandle depression og andre sygdomme
English: Each capsule contains 84.4 mg of eliglustat (as tartrate).
Danish: Hver kapsel indeholder 84,4 mg eliglustat (som tartrat).
English: Before initiation of treatment with Cerdelga, patients should be genotyped for CYP2D6 to determine the CYP2D6 metaboliser status (see section 4.2, Special populations).
Danish: Før påbegyndelse af behandling med Cerdelga skal patienterne genotypebestemmes for CYP2D6 for bestemmelse af CYP2D6-metaboliseringsstatus (se pkt.
English: After repeated 84 mg twice daily doses of eliglustat in PMs, concomitant administration of repeated 600 mg once daily doses of rifampicin resulted in an approximately 95% decrease in eliglustat exposure.
Danish: Efter gentagne doser med 84 mg eliglustat to gange dagligt hos PM'er, resulterede samtidig administration af gentagne doser med 600 mg rifampicin en gang om dagen i et fald i eliglustat-eksponering på ca. 95 %.
English: Percentage Change in Liver Volume MN (%)
Danish: Procentvis ændring i levervolumen MN (%)
English: 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.
Danish: Hos CYP2D6-ekstensive metabolisatorer (EM´er) med let nedsat leverfunktion (Child-Pugh klasse A) er der ikke behov for dosisjustering, og den anbefalede dosis er 84 mg eliglustat to gange dagligt.
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
Danish: Tabel 2: Ændring fra baseline til måned 9 (primær analyseperiode) hos behandlingsnaive patienter med GD1-behandling, som fik Cerdelga i studie 02507
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.
Danish: Ved en dosering med eliglustat på 84 mg to gange dagligt hos ikke-PM'er, forudsiges det, at samtidig brug af potente eller moderate CYP2D6-hæmmere og potente eller moderate CYP3A-hæmmere vil forøge Cmax og AUC0-12 med henholdsvis 17- og 25-gange større.
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.
Danish: Efter en enkelt 0,25 mg dosis digoxin, et P-gp-substrat, resulterede samtidig administration af 127 mg doser af eliglustat to gange dagligt i henholdsvis 1,7- og 1,5-gange større digoxin Cmax og AUClast.
English: Following repeated dosing of eliglustat 84 mg twice daily in non-PMs and once daily in PMs, steady state was reached by 4 days, with an accumulation ratio of 3-fold or less.
Danish: Efter gentagen dosering af eliglustat 84 mg to gange dagligt hos ikke-langsomme metabolisatorer og en gang dagligt hos langsomme metabolisatorer (PM'er), blev steady state nået efter 4 dage med et akkumuleringsforhold på en 3-dobling eller derunder.
English: Clinical experience in CYP2D6 poor metabolisers (PMs) and ultra-rapid metabolisers (URMs)
Danish: Kliniske erfaringer hos poor CYP2D6- metabolisers (PM'er) og ultra-hurtige metabolisers (URM'er):
English: Eliglustat is also contraindicated in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor.
Danish: Eliglustat er også kontraindiceret til patienter, som har dårlig (PM´er) CYP2D6 metabolisering, og som tager en stærk CYP3Ahæmmer.
English: • aprepitant - antiemetic (used to reduce vomiting)
Danish: • aprepitant - antiemetika (bruges til at reducere opkastning)
English: • phenytoin - anti-epileptic (used to treat epilepsy and seizures)
Danish: • phenytoin - anti-epileptika (bruges til at behandle epilepsi og anfald)
English: What you need to know before you take Cerdelga Do not take Cerdelga
Danish: Det skal du vide, før du begynder at tage Cerdelga Tag ikke Cerdelga:
English: Limited data are available in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment.
Danish: Begrænsede data er tilgængelige hos CYP2D6-ekstensive metabolisatorer (EM'er) med moderat nedsat leverfunktion.
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.
Danish: Efter gentagne doser af eliglustat på 127 mg to gange dagligt hos ikke-PM'er resulterede samtidig administration én gang dagligt af gentagne 600 mg doser af rifampicin (en stærk induktor af CYP3A samt efflukstransporteren P-gp) i et fald i eliglustat-eksponering på ca. 85 %.
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.
Danish: Man bør overveje en dosis på 84 mg eliglustat en gang om dagen, når der samtidig bruges en stærk CYP2D6-hæmmer (f.eks. paroxetin, fluoxetin, quinidin, bupropion) hos IM'er og EM'er.
English: Other medicines and Cerdelga
Danish: Brug af anden medicin sammen med Cerdelga
English: o Use of eliglustat with strong CYP3A inducers substantially decreases the exposure to eliglustat, which may reduce the therapeutic effectiveness; therefore concomitant administration is not recommended.
Danish: Brug af eliglustat med potente CYP3A-induktorer nedsætter eksponeringen for eliglustat væsentligt, hvilket kan reducere den terapeutiske effektivitet af eliglustat.
English: Year 3
Danish: År 3
English: Caution should be used with strong or moderate CYP3A inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Danish: Der bør udvises forsigtighed med stærke eller moderate CYP3A-hæmmere hos intermediære metabolisatorer (IM´er) og ekstensive metabolisatorer (EM´er).
English: 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).
Danish: Begrænsede eller ingen data er tilgængelige hos CYP2D6-ekstensive metabolisatorer (EM'er), intermediære metabolisatorer (IM'er) eller langsomme metabolisatorer (PM'er) med ESRD og hos CYP2D6-intermediære metabolisatorer (IM'er) eller langsomme metabolisatorer (PM'er) med let, moderat eller alvorlig nedsat nyrefunktion; Anvendelse af eliglustat hos disse patienter anbefales ikke (se pkt.
English: • nortryptyline, amitriptyline, imipramine, desipramine - antidepressants (used to treat depression)
Danish: • nortryptylin, amitriptylin, imipramin, desipramin - antidepressiva (bruges til at behandle depression)
English: o A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 inhibitor is used concomitantly in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Danish: • En dosis eliglustat 84 mg en gang dagligt bør overvejes, når en stærk CYP2D6-hæmmer anvendes samtidigt hos intermediære metabolisatorer (IM´er) og ekstensive metabolisatorer (EM´er).
English: The use of a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor is contraindicated in IMs and EMs.
Danish: Brugen af potente eller moderate CYP2D6-hæmmere samtidigt med en stærk eller moderat CYP3A-hæmmer er kontraindikeret hos IM'er og EM'er.
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.
Danish: Efter en enkelt 50 mg dosis metoprolol, et CYP2D6-substrat, resulterede samtidig administration af gentagne 127 mg doser eliglustat to gange dagligt i henholdsvis 1,5- og 2,1-gange større metoprolol Cmax og AUC.
English: Each capsule contains 106 mg lactose (as monohydrate).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver kapsel indeholder 106 mg laktose (som monohydrat).
English: How to take Cerdelga
Danish: Sådan skal du tage Cerdelga
English: Tел: +359 2 9705300
Danish: SANOFI-BULGARIA EOOD Tел: +359 2 9705300
English: After 18 months of Cerdelga treatment in the open-label extension phase, the mean (SD) lumbar spine Bone Mineral Density T-score increased from -1.14 (1.0118) at Baseline (n=34) to -0.918 (1.1601) (n=33) in the normal range.
Danish: BMD) fra -1,14 [1,0118] ved baseline (n=34) til -0,918 [1,1601] (n=33) i normalområdet.
English: • are an extensive metaboliser and you have moderately reduced liver function.
Danish: • er en ekstensiv metabolisator, og du har moderat nedsat leverfunktion.
English: Percentage of Patients with stable liver volumea
Danish: Levervolumen Procentdel af patienter med stabilt levervolumena
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).
Danish: Efter en enkelt dosis på 84 mg var eliglustat Cmax og AUC ensartet hos CYP2D6-ekstensive metabolisatorer (EM'er) med alvorlig nedsat nyrefunktion og raske CYP2D6- ekstensive metabolisatorer (EM'er).
English: • are an intermediate or poor metaboliser and you have any level of reduced liver function.
Danish: • er en intermediær eller en langsom metabolisator, og du har nogen form for nedsat leverfunktion.
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.
Danish: Efter gentagne doser af eliglustat 84 mg to gange dagligt hos ikke-PM'er resulterede samtidig administration med gentagne 30 mg doser én gang dagligt af paroxetin, en stærk hæmmer af CYP2D6, i en stigning på 7,3- og 8,9-gange større af henholdsvis eliglustat Cmax og AUC0-12.
English: Change from Baseline (Mean)
Danish: Ændring i forhold til baseline (middel)
English: • Periodic safety update reports (PSURs)
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: 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.
Danish: Samtidig administration af eliglustat med P-gp- eller CYP2D6-substratstoffer kan øge plasmakoncentrationen af disse stoffer.
English: Limited or no data are available in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment.
Danish: Begrænsede eller ingen data er tilgængelige hos CYP2D6-intermediære metabolisatorer (IM'er) eller langsomme metabolisatorer (PM'er) med nogen grad af nedsat leverfunktion.
English: Each capsule contains 84 mg of eliglustat (as tartrate)
Danish: Hver kapsel indeholder 84 mg eliglustat (som tartrat).
English: Use of Cerdelga under these conditions results in substantially elevated eliglustat plasma concentrations (see section 4.4 and 4.5).
Danish: Brug af Cerdelga under disse forhold resulterer i væsentligt forhøjede eliglustat-plasmakoncentrationer (se pkt.
English: The effect of severe hepatic impairment was not studied in subjects with any CYP2D6 phenotype (see sections 4.2, 4.3 and 4.4).
Danish: Virkningen af alvorlig nedsat leverfunktion blev ikke undersøgt hos personer med nogen CYP2D6-fænotype (se pkt.
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).
Danish: Efter gentagne doser 84 mg Cerdelga en gang daglig forventes Cmax og AUC0-24 at være 3,1 og 3,2 gange højere hos CYP2D6-ekstensive metabolisatorer (EM'er) med moderat nedsat leverfunktion sammenlignet med raske CYP2D6-ekstensive metabolisatorer (EM'er), som modtager Cerdelga 84 mg to gange dagligt (se pkt.
English: Caution should be used with moderate CYP2D6 inhibitors in IMs and EMs.
Danish: Der skal udvises forsigtighed med moderate CYP2D6-hæmmere hos IM'er og EM'er.
English: Caution should be used with weak CYP3A inhibitors in poor metabolisers (PMs).
Danish: Der bør udvises forsigtighed med svage CYP3Ahæmmere hos langsomme metabolisatorer (PM´er).
English: In poor metabolisers (PMs):
Danish: Hos langsomme metabolisatorer (PM'er)
English: In CYP2D6 EMs with end stage renal disease (ESRD), eliglustat is not recommended (see sections 4.4 and 5.2).
Danish: Hos CYP2D6-EM´er med nyresygdom i slutstadiet (ESRD) anbefales eliglustat ikke (se pkt.
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).
Danish: Efter gentagne doser 84 mg Cerdelga to gange dagligt forventes Cmax og AUC0-12 at være 2,4 og 2,9 gange højere hos CYP2D6-ekstensive metabolisatorer (EM'er) med let nedsat leverfunktion og 6,4 og 8,9 gange højere hos CYP2D6-ekstensive metabolisatorer (EM'er) med moderat nedsat leverfunktion sammenlignet med raske CYP2D6- ekstensive metabolisatorer (EM'er).
English: Agents that may increase eliglustat exposure
Danish: Stoffer, som kan øge koncentrationen af eliglustat