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Cerdelga · 4.5 · CYP3A inhibitors in EMs with mild hepatic impairment See sections 4.2 and 4.4.
Eintrag öffnenCerdelga · 4.5 · CYP3A inhibitors in EMs with moderate or severe hepatic impairment See sections 4.2 and 4.3.
Eintrag öffnenCerdelga · 4.5 · CYP3A inhibitors in IMs and EMs After repeated 84 mg twice daily doses of eliglustat in non-PMs, concomitant a
Eintrag öffnenCerdelga · 4.5 · CYP3A inhibitors in PMs At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant us
Eintrag öffnenCerdelga · 4.5 · Caution should be used with weak CYP3A inhibitors (e.g., amlodipine, cilostazol, fluvoxamine, goldenseal, ison
Eintrag öffnenCerdelga · 4.5 · Cerdelga is contraindicated in patients who are CYP2D6 IMs or EMs taking a strong or moderate CYP2D6 inhibitor
Eintrag öffnenCerdelga · 4.5 · Eliglustat is metabolised primarily by CYP2D6 and to a lesser extent by CYP3A4. Concomitant administration of
Eintrag öffnenCerdelga · 4.5 · Grapefruit products contain one or more components that inhibit CYP3A and can increase plasma concentrations o
Eintrag öffnenCerdelga · 4.5 · P-gp substrates After a single 0.25 mg dose of digoxin, a P-gp substrate, concomitant administration of 127 mg
Eintrag öffnenCerdelga · 4.5 · Strong CYP3A inducers After repeated 127 mg twice daily doses of eliglustat in non-PMs, concomitant administra
Eintrag öffnenCerdelga · 4.5 · The list of substances in section 4.5 is not an inclusive list and the prescriber is advised to consult the Sm
Eintrag öffnenCerdelga · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenCerdelga · 4.8 Undesirable effects · 1
Eintrag öffnenCerdelga · 4.8 · 8 Reporting of suspected adverse reactions
Eintrag öffnenCerdelga · 4.8 · Adverse reactions are ranked by system organ class and frequency ([very common (≥ 1/10); common (≥ 1/100 to <
Eintrag öffnenCerdelga · 4.8 · In the ELIKIDS paediatric study Cohort 1 (eliglustat monotherapy), the most common adverse reactions were dysp
Eintrag öffnenCerdelga · 4.8 · Paediatric population
Eintrag öffnenCerdelga · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenCerdelga · 4.8 · Summary of the safety profile
Eintrag öffnenCerdelga · 4.8 · System organ class Common Nervous system disorders Headache*, dizziness*, dysgeusia Cardiac disorders Palpitat
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